what is the advance plan of research called

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Advance Care Planning: Advance Directives for Health Care

On this page:

What is advance care planning?

What are advance directives, who needs an advance care plan, what happens if you do not have an advance directive, will an advance directive guarantee your wishes are followed.

• Other advance care planning decisions and forms

How can you get started with advance care planning?

How to find advance directive forms.

During an emergency or at the end of life , you may face questions about their medical treatment and not be able answer them. You may assume your loved ones know what you would want, but that’s not always true. In one study, people guessed nearly one out of three end-of-life decisions for their loved one incorrectly.

Research shows that you are more likely to get the care you want if you have conversations about your future medical treatment and put a plan in place. It may also help your loved ones grieve more easily and feel less burden, guilt, and depression.

Advance care planning involves discussing and preparing for future decisions about your medical care if you become seriously ill or unable to communicate your wishes. Having meaningful conversations with your loved ones is the most important part of advance care planning. Many people also choose to put their preferences in writing by completing legal documents called advance directives.

Advance Care Planning: A Conversation Guide

Want to learn more about advance care planning? NIA's guide offers conversation tips, worksheets, and more.

Advance directives are legal documents that provide instructions for medical care and only go into effect if you cannot communicate your own wishes.

The two most common advance directives for health care are the living will and the durable power of attorney for health care.

• Living will: A living will is a legal document that tells doctors how you want to be treated if you cannot make your own decisions about emergency treatment. In a living will, you can say which common medical treatments or care you would want, which ones you would want to avoid, and under which conditions each of your choices applies. Learn more about preparing a living will .
• Durable power of attorney for health care: A durable power of attorney for health care is a legal document that names your health care proxy, a person who can make health care decisions for you if you are unable to communicate these yourself. Your proxy, also known as a representative, surrogate, or agent, should be familiar with your values and wishes. A proxy can be chosen in addition to or instead of a living will. Having a health care proxy helps you plan for situations that cannot be foreseen, such as a serious car accident or stroke. Learn more about choosing a health care proxy .

Think of your advance directives as living documents that you review at least once each year and update if a major life event occurs such as retirement, moving out of state, or a significant change in your health.

Advance care planning is not just for people who are very old or ill. At any age, a medical crisis could leave you unable to communicate your own health care decisions. Planning now for your future health care can help ensure you get the medical care you want and that someone you trust will be there to make decisions for you.

Advance care planning for people with dementia

Many people do not realize that Alzheimer’s disease and related dementias are terminal conditions and ultimately result in death. People in the later stages of dementia often lose their ability to do the simplest tasks. If you have dementia, advance care planning can give you a sense of control over an uncertain future and enable you to participate directly in decision-making about your future care. If you are a loved one of someone with dementia, encourage these discussions as early as possible. In the later stages of dementia, you may wish to discuss decisions with other family members, your loved one’s health care provider, or a trusted friend to feel more supported when deciding the types of care and treatments the person would want.

If you do not have an advance directive and you are unable to make decisions on your own, the state laws where you live will determine who may make medical decisions on your behalf. This is typically your spouse, your parents if they are available, or your children if they are adults. If you are unmarried and have not named your partner as your proxy, it’s possible they could be excluded from decision-making. If you have no family members, some states allow a close friend who is familiar with your values to help. Or they may assign a physician to represent your best interests. To find out the laws in your state, contact your state legal aid office or state bar association.

An advance directive is legally recognized but not legally binding. This means that your health care provider and proxy will do their best to respect your advance directives, but there may be circumstances in which they cannot follow your wishes exactly. For example, you may be in a complex medical situation where it is unclear what you would want. This is another key reason why having conversations about your preferences is so important. Talking with your loved ones ahead of time may help them better navigate unanticipated issues.

There is the possibility that a health care provider refuses to follow your advance directives. This might happen if the decision goes against:

• The health care provider’s conscience
• The health care institution’s policy
• Accepted health care standards

In these situations, the health care provider must inform your health care proxy immediately and consider transferring your care to another provider.

Other advance care planning forms and orders

You might want to prepare documents to express your wishes about a single medical issue or something else not already covered in your advance directives, such as an emergency. For these types of situations, you can talk with a doctor about establishing the following orders:

• Do not resuscitate (DNR) order: A DNR becomes part of your medical chart to inform medical staff in a hospital or nursing facility that you do not want CPR or other life-support measures to be attempted if your heartbeat and breathing stop. Sometimes this document is referred to as a do not attempt resuscitation (DNR) order or an allow natural death (AND) order. Even though a living will might state that CPR is not wanted, it is helpful to have a DNR order as part of your medical file if you go to a hospital. Posting a DNR next to your hospital bed might avoid confusion in an emergency. Without a DNR order, medical staff will attempt every effort to restore your breathing and the normal rhythm of your heart.
• Do not intubate (DNI) order: A similar document, a DNI informs medical staff in a hospital or nursing facility that you do not want to be on a ventilator.
• Do not hospitalize (DNH) order: A DNH indicates to long-term care providers, such as nursing home staff, that you prefer not to be sent to a hospital for treatment at the end of life.
• Out-of-hospital DNR order: An out-of-hospital DNR alerts emergency medical personnel to your wishes regarding measures to restore your heartbeat or breathing if you are not in a hospital.
• Physician orders for life-sustaining treatment (POLST) and medical orders for life-sustaining treatment (MOLST) forms: These forms provide guidance about your medical care that health care professionals can act on immediately in an emergency. They serve as a medical order in addition to your advance directive. Typically, you create a POLST or MOLST when you are near the end of life or critically ill and understand the specific decisions that might need to be made on your behalf. These forms may also be called portable medical orders or physician orders for scope of treatment (POST). Check with your state department of health to find out if these forms are available where you live.

You may also want to document your wishes about organ and tissue donation and brain donation . As well, learning about care options such as palliative care and hospice care can help you plan ahead.

To get started with advance care planning, consider the following steps:

• Reflect on your values and wishes. This can help you think through what matters most at the end of life and guide your decisions about future care and medical treatment.
• Talk with your doctor about advance directives. Advance care planning is covered by Medicare as part of your annual wellness visit. If you have private health insurance, check with your insurance provider. Talking to a health care provider can help you learn about your current health and the kinds of decisions that are likely to come up. For example, you might ask about the decisions you may face if your high blood pressure leads to a stroke.
• Choose someone you trust to make medical decisions for you. Whether it’s a family member, a loved one, or your lawyer, it’s important to choose someone you trust as your health care proxy. Once you’ve decided, discuss your values and preferences with them. If you’re not ready to discuss specific treatments or care decisions yet, try talking about your general preferences. You can also try other ways to share your wishes, such as writing a letter or watching a video on the topic together.
• Complete your advance directive forms. To make your care and treatment decisions official, you can complete a living will. Similarly, once you decide on your health care proxy, you can make it official by completing a durable power of attorney for health care.
• Share your forms with your health care proxy, doctors, and loved ones. After you’ve completed your advance directives, make copies and store them in a safe place. Give copies to your health care proxy, health care providers, and lawyer. Some states have registries that can store your advance directive for quick access by health care providers and your proxy.
• Keep the conversation going. Continue to talk about your wishes and update your forms at least once each year or after major life changes. If you update your forms, file and keep your previous versions. Note the date the older copy was replaced by a new one. If you use a registry, make sure the latest version is on record.

Everyone approaches the process differently. Remember to be flexible and take it one step at a time. Start small. For example, try simply talking with your loved ones about what you appreciate and enjoy most about life. Your values, treatment preferences, and even the people you involve in your plan may change over time. The most important part is to start the conversation.

You can establish your advance directives for little or no cost. Many states have their own forms that you can access and complete for free. Here are some ways you might find free advance directive forms in your state:

• Contact your State Attorney General’s Office.
• Contact your local Area Agency on Aging . You can find your area agency phone number by visiting the Eldercare Locator or by calling 800-677-1116.
• Download your state’s form online from one of these national organizations: AARP , American Bar Association , or National Hospice and Palliative Care Organization .
• If you are a veteran, contact your local Veteran’s Affairs (VA) office . The VA offers an advance directive specifically for veterans .

Some people spend a lot of time in more than one state. If that's your situation, consider preparing advance directives using the form for each state, and keep a copy in each place, too.

Do you need a lawyer to create advance directives?

Not necessarily. A lawyer can help but is not required to create your advance directives. However, if you have a lawyer, you should give them a copy of your advance directive. If you need help with planning, contact your local Area Agency on Aging. Other possible sources of legal assistance and referral include state legal aid offices, state bar associations, and local nonprofit agencies, foundations, and social service agencies.

There are also organizations that enable you to create, download, and print your forms online, but they may charge fees. Before you pay, remember there are several ways to get your forms for free. Some free online resources include:

• PREPARE for Your Care : An interactive online program that was funded in part by NIA. It is available in English and Spanish.
• The Conversation Project : A series of online conversation guides and advance care documents available in English, Spanish, and Chinese. The Conversation Project is a public engagement initiative led by the Institute for Healthcare Improvement.

If you use forms from a website, check to make sure they are legally recognized in your state. You should also make sure the website is secure and will protect your personal information. Read the website’s privacy policy and check that the website link begins with “https” (make sure it has an “s”) and that it has a small lock icon next to its web address.

Some people also choose to carry a card in their wallet indicating they have an advance directive and where it is kept. Below is an example from the American Hospital Association (PDF, 40KB).

You may also be interested in

• Finding out more about choosing a health care proxy
• Learning about legal and financial planning for people with dementia
• Reading about preparing a living will

Sign up for e-alerts about healthy aging

For more information about advance directives.

Administration for Community Living (ACL) 202-401-4634 https://www.acl.gov

Department of Veterans Affairs 877-222-8387 www.va.gov/geriatrics

OrganDonor.gov Health Resources & Services Administration www.organdonor.gov

American Bar Association 800-285-2221  www.americanbar.org

CaringInfo National Hospice and Palliative Care Organization 800-658-8898 [email protected] www.caringinfo.org

The Conversation Project 866-787-0831 https://theconversationproject.org

National POLST 202-780-8352 [email protected] www.polst.org

PREPARE for Your Care [email protected] https://prepareforyourcare.org 

This content is provided by the NIH National Institute on Aging (NIA). NIA scientists and other experts review this content to ensure it is accurate and up to date.

Content reviewed: October 31, 2022

nia.nih.gov

An official website of the National Institutes of Health

Advanced research methods: Overview

• Reading scholarly research

This guide is a  general introduction  to scholarly inquiry and the use of advanced research methods, scroll down for definitions, examples and helpful resources.

Understanding Formal Research

Research is defined as the systematic investigation of a subject in order to find something new.

There are many different Advanced Research Methods which are used to conduct research . These methods include:

• Originating with a question or problem
• Starting with a clear articulation of a goal
• Creating a specific plan for proceeding
• Dividing the problem into smaller more manageable sub-problems
• Leading with the specific research problem, question, or hypothesis
• Explaining the assumptions the researcher is starting with
• The collection & interpretation of data
• Results in further questions and new tangents for further research

[Adapted from: Leedy, Paul D, Jeanne E. Ormrod, and Laura R. Johnson.  Practical Research: Planning and Design . Ninth edition, Pearson, 2010. ]

Qualitative versus Quantitative

Quantitative studies are best suited for answering questions that require 'count-able' data, quantities that are often easy to translate into a graph.

For example: "How many times an hour do 22 to 32 year olds check their cell-phone?"

Quantitative: think "describe" ... precise measurements - specific data variables - large sample size - randomly selected - Objective - generalisable to larger populations - Confirmatory : the researcher expects to prove or disprove a hypothesis - Output = Statistical report with clear categories of data

Quantitative Methods: surveys, questionnaires, experiments, analyzing existing data

Qualitative studies are best suited for investigating qualities of a specific issue, often human behaviours or motivations which cannot be easily transformed in to a graph. 

For example: "Why do 22 to 32 year olds prefer social media app A over social media app B." or “what motivates 22 to 32 year olds to stop using a social media platform or app?”

Qualitative: think "discover" ...open-ended responses - non-specific data - small sample size - not randomly selected - Subjective - situational or highly specific information - Exploratory : the researcher is looking for connections, patterns or themes  Output = narrative and contextual reporting or summaries of responses. 

Qualitative Methods: Interviews, case studies, action research, historical research, participant observer, phenomenology and philosophical / intellectual analysis

Mixed Method studies are best suited for highly complex questions: for example the number of times a specific  behaviour is observed, under what conditions.

The research question for a mixed methods study could be " Are people who check their phone more than average also more likely to discard social media apps?”

Sampling and Sample types

You must choose a sample that is likely to help answer your research question!

Sample types: the many diverse possible sources of data that researchers choose from.

Sampling: the process of choosing which source of data to focus on.

Example: Choosing between an online survey , or interviewing 22 to 32 year olds , to discover which social media apps they have used and then discarded, or used and kept, and what they think motivated those decisions? The researcher could also contact the App creators for any demographic or usage statistics that they are willing to provide.

Validity and Reliability

Validity means that your methods measure what you actually set out to measure and that the results you gain from your methods can be trusted.

Reliability means that a different researcher could reproduce your methods - using similar conditions/ same variables - and see the same results as you did or draw similar conclusions.

If you chose to use a  question with   Likert scale  responses on your survey about social media apps:

“How likely are you to Keep Social media app 'A3' on your mobile device?”

Answer options: 1. “very likely” 2. “somewhat likely” 3. Neutral    4. “somewhat unlikely” 5. “very unlikely”

How can you guarantee that the people taking the survey will interpret those categories in the way you meant them?  Perhaps you could change the question to something more concrete and less open to interpretation.

"How long did you use social media app 'A3' on your Mobile device before deleting it?"

A. 5 days or less.      B. 1 -2 weeks      C.   1 - 2 months        D. 3 to 6 months      E. 7 months or longer.

Definition of Likert Scale: "A method of ascribing quantitative value to qualitative data, to make it amenable to statistical analysis. A numerical value is assigned to each potential choice and a mean figure for all the responses is computed at the end of the evaluation or survey."   <Definition from: Business Dictionary >

VIDEO Adv Research Methods

Advanced Research Methods

Before you get started ⇒ think about the questions below, and keep them in mind as you work on your project.

• What type of new knowledge are you seeking?
• Will your research answer a clearly defined question or fill a specific information gap?
• Have you considered how each method might impact your results?
• Are you certain that the methods you have chosen are valid and reliable?

Remember: 

• Your method should be directly related to the nature of the answers you are seeking.
• Each research method requires unique measures of validity
• Tutorial: How to Read Scholarly Materials (2019 update)
• Video: How to Read Scholarly Materials
• Reading Scholarly Research - Camosun
• Conducting a Literature Review - UToronto
• Research methods and statistics in psychology
• Essentials of business research methods
• A concise introduction to mixed methods research

Examples & more resources

• RADAR Framework - Loyola Marymount University Rationale - Authority - Date - Accuracy - Relevance
• Writing a Research Proposal - UCLA
• "Mixed Methods" Chap 7 of Leedy & Ormond's Practical Research
• Sample Qualitative Study (UBC ~ Health Research)
• Sample Mixed Methods study (Undergrad UBC)

Evaluating sources

• Evaluating the Evidence:Evidence-Based Practice for Nursing (East Carolina University)
• Evidence Based Medicine 'Evidence Pyramid' (UToronto)

Resources from other colleges

• Research Questions - the good and the not so good. (Prezi)
• Key Elements of the Research Proposal
• Tips for Reading scholarly research (AET Guide)
• UCLA Guide to Advanced Research Methods
• The Four Types of Data
• NCRM Podcasts Podcasts from the National Centre for Research Methods (UK)
• Duke University Qualitative Methods Guide
• Duke University Research Data Management

BC Campus Open Textbooks

Find more Open Access Textbooks at:

• BC Open Campus
• Principles of Sociological Inquiry: Qualitative and Quantitative Methods
• Research Methods in Psychology
• Communication Theory

Ask a librarian

Need help with your research? Use AskAway, a chat-based library help service.

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• Last Updated: May 9, 2022 11:07 AM
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Advanced research projects agency for health (arpa-h).

Visit the ARPA-H.gov website

The Advanced Research Projects Agency for Health (ARPA-H) supports the development of high-impact research to drive biomedical and health breakthroughs to deliver transformative, sustainable, and equitable health solutions for everyone.* ARPA-H’s mission focuses on leveraging research advances for real world impact.

ARPA-H advances high-potential, high-impact biomedical and health research that cannot be readily accomplished through traditional research or commercial activity. ARPA-H awardees are developing entirely new ways to tackle the hardest challenges in health. The ARPA model enables visionary Program Managers to tackle a specific problem, working with a range of performers and a variety of approaches to solve that problem, while incorporating measurement and evaluation throughout the process. Program Managers serve for limited terms to ensure a constant infusion of fresh thinking and new perspectives.

ARPA-H is collaborative, spirited, and driven by a commitment to accelerating life-changing health solutions. ARPA-H staff embody teamwork, mutual respect, and dedication to diversity in all its forms. If this sounds like the environment for you, check out the  opportunities  to work with ARPA-H.

Stay up to date and engage with ARPA-H on LinkedIn , Twitter , Instagram, and YouTube.

* President Biden proposed the creation of the Advanced Research Projects Agency for Health (ARPA-H) to improve the U.S. government’s ability to speed biomedical and health research. Public Law 117-103 was enacted on March 15, 2022, authorizing the establishment of ARPA-H within the U.S. Department of Health and Human Services.  

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Advance care planning explained

Advance care planning involves planning for your future health care and communicating your treatment preferences.

Advance care planning involves planning for your future health care. It enables you to make some decisions now about the health care you would or would not like to receive if you were to become seriously ill and unable to communicate your preferences or make treatment decisions.

Advance care planning gives you the opportunity to think about, discuss and record your preferences for the type of care you would like to receive and the outcomes you would consider acceptable. Advance care planning helps to ensure your loved ones and health providers know what matters most to you and respect your treatment preferences.

Ideally, advance care planning will result in your preferences being  documented in a plan known as an advance care directive and the appointment of a  substitute decision-maker to help ensure your preferences are respected.

Life is full of moments when it's important to be open, to be ready and to be heard. This is especially true when it's time to consider advance care planning. To help, here's how you can plan for tomorrow so you can live for today.

Be open to thinking about your beliefs and preferences for care. This includes thinking about what you value most and the treatments you would choose to have or not have. Most importantly, you'll need to think of who you would trust to make these decisions for you.

Be ready to talk about your beliefs and preferences for care with your loved ones, your health care professionals, and make sure they understand the way you see things. Ask questions if anything is uncertain, and try to consider what they might need to know about you to make decisions later. Be ready to make choices, starting with the appointment of your substitute decision-maker. They'll need to be over 18, as well as someone who listens carefully and understands your preferences. Either way, it needs to be someone you trust to make decisions on your behalf. Be heard by documenting and sharing your plan. First, write it down so that if others need to make decisions for you, they'll know what you would have wanted. Share your plan with your loved ones, your substitute decision-maker and the health care professionals responsible for your care. This way, everyone's on the same page.

It may be difficult, but it makes sense to plan for tomorrow so you can live for today. Be open, be ready, be heard. To make your plan, visit our website or call for advice and support.

Why it's important

Advance care planning benefits everyone: you, your family, carers and health professionals.

• It helps to ensure you receive the care you actually want
• It improves ongoing and end-of-life care, along with personal and family satisfaction
• Families of people who have undertaken advance care planning have less anxiety, depression, stress and are more satisfied with care
• For healthcare professionals and organisations, it reduces unnecessary transfers to acute care and unwanted treatment

If you haven't documented your preferences or identified a substitute decision-maker, and you become seriously ill or injured, doctors will make treatment decisions based on their assessment of your best interests. This may include treatments that you would not want.

Planning is for everyone

Everyone should consider advance care planning, regardless of your age or health. Ideally, you should start planning when you're healthy - before there's actually an urgent need for a plan.

It is particularly important if you:

• have a chronic illness
• have multiple diseases
• have an early cognitive impairment
• are approaching the end of your life

It's a team effort

Advance care planning requires a team effort. It involves having conversations with your family, friends, doctors, care workers and other health professionals. Having these conversations will help you start thinking about what's important to you.

Learn more about  starting the conversation .

The process

Advance care planning doesn't need to be complicated but it does require careful consideration. It involves thinking about your values and preferences for care and acceptable outcomes, talking about them with others, appointing someone to make decisions on your behalf and documenting everything.

Learn more about the  advance care planning process .

Advance care directives and advance care plans

These two terms are used regularly when talking about advance care planning, however they are distinctly different and it's important to understand this difference.

Advance care directives

An advance care directive involves documenting your preferences for future care yourself. It can include your values, life goals and preferred outcomes, and directions about care and treatments. You can also formally appoint a substitute decision-maker in an advance care directive.

The process of creating an advance care directive and the names of the required documents varies between states and territories.

Advance care directives are legally binding and the preferences for health care that you document must be followed.

Advance care plans

An advance care plan is created by someone else on behalf of a person with diminished or no capacity to make decisions for themselves.

An advance care plan can include an individual’s beliefs, values and preferences in relation to future care decisions. They are often helpful in providing information for substitute decision-makers and health practitioners and may guide care decisions but are not necessarily legally binding.

Some states and territories provide forms to help document an advance care plan for a non-competent person.

It's not voluntary assisted dying

There are very significant differences between advance care planning and voluntary assisted dying (VAD). Advance care planning is the process of discussing and choosing future health care and medical treatment options. It is about people making decisions about their medical treatment including future consent to, refusal or withdrawing of treatment, and substitute decision-making. All people can do advance care planning and all adults (and children in Victoria) with decision-making capacity are eligible to document an advance care directive.

Voluntary assisted dying involves a process to access medication and to enable a person to legally choose the manner and timing of their death. Voluntary assisted dying (VAD) laws have now been passed in all of Australia’s six states -   Victoria, New South Wales, Western Australia, Tasmania, South Australia, and Queensland . It is still illegal in the Northern Territory and the Australian Capital Territory as Commonwealth laws currently prevent the Territories from legislating on VAD.

Notification of death

Death notifications are not part of the advance care planning process. To find information about this, we recommend visiting the  Australian Death Notification Service .

Contact our   National Advance Care Planning Support Service TM on  1300 208 582 for more information and advice. We're available 9am – 5pm, Monday – Friday (AEST).

Christina's story

Christina was 68, two years into retirement and living the ‘sea change’ dream when she suffered a brain aneurysm at home. Her condition was serious but treatable and she agreed to surgery. During the operation Christina unfortunately suffered a massive bleed in the brain. She never regained her ability to talk to her family again.

With the plan Christina had created to guide them, her sons and medical team made the tough but necessary decisions to ensure her preferences were respected.

Read Christina's story

Last updated:  April 2024

GENERAL | October 15, 2020

19 Evidence-Based Benefits of Advance Care Planning

Reading Time: 2 minutes

Advance care planning (ACP) is an ongoing conversation that involves shared decision making to clarify and document – through an advance directive – an individual’s wishes, preferences, and goals regarding future medical care. This comprehensive process is critically important to ensuring patients receive the medical care they want in the event they lose the capacity to make their own decisions. Although advance care planning and completion of an advance directive can bridge the gap between the medical care patients want and the care they receive, a recent study found that two-thirds of U.S. adults do not have an advance directive .

Not only does ACP enable patients and their families to make informed healthcare decisions, it also supports the delivery of high quality care and more effective utilization of healthcare services. Studies have also shown that advance care planning improves quality of care and patient outcomes.

Here are nineteen evidence-based benefits of ACP for healthcare systems, healthcare professionals, patients, and their families:

• Enables healthcare professionals to conduct structured, meaningful conversations with patients about their wishes and preferences regarding treatment goals, preferences, and location of care 1
• Promotes patient-centered care by focusing on the patients’ personal preferences about their medical care and treatments 2
• Helps ensure that patients receive care that is consistent with their preferences 3
• Raises the likelihood that healthcare providers and families understand and comply with a patient’s preferences for medical care when the patient lacks decision-making capacity 4 , 5
• Increases the probability that patients with life-limiting illnesses can die in their preferred place, such as their home 6
• Allows healthcare professionals and caregivers to proactively arrange for patients near end of life to remain at home, in a nursing home, or in a hospice facility rather than going to a hospital 6 , 7
• Reduces the decisional burden of families as to whether they are making decisions that are consistent with the preferences of a loved one 3
• Improves the bereavement experience of families by reducing stress, anxiety, and depression after a loved one’s death 8 , 9
• Enhances families’ satisfaction with end-of-life care and understanding of what to expect during a loved one’s dying process 10 , 11
• May reduce moral distress among critical care nurses 12
• Positively impacts quality of life and end-of-life care by preventing unwanted hospitalizations and increasing the utilization of palliative and hospice services 13 , 11
• Diminishes the use of aggressive or intensive treatments at the end of life and reduces the number and/or length of hospital admissions 8 , 14 , 11
• Decreases in-hospital and intensive care unit deaths 13
• Reduces the cost of end-of-life care without increasing mortality 15 , 11
• Promotes higher completion rates of advance directives 5 , 10
• Boosts the effectiveness of meeting patients’ end-of-life wishes over written documents alone 13
• Improves end-of-life care for individuals with dementia by allowing them to express their care preferences before cognitive function deteriorates to the point they are unable to make their own medical decisions 16
• Improves outcomes and patient experience while reducing health-related costs for high-risk, high-needs patients 17
• Improves population health as a result of increased goal-concordant care 18

Is your healthcare organization interested in implementing or improving your advance care planning initiative? We can help! The efficacy of ACP Decision’s extensive advance care planning video library has been proven in over 20 clinical trials involving over thousands of people from diverse patient populations in various clinical settings. Contact us today to get started!

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Module 1: Introduction: What is Research?

Learning Objectives

By the end of this module, you will be able to:

• Explain how the scientific method is used to develop new knowledge
• Describe why it is important to follow a research plan

The Scientific Method consists of observing the world around you and creating a  hypothesis  about relationships in the world. A hypothesis is an informed and educated prediction or explanation about something. Part of the research process involves testing the  hypothesis , and then examining the results of these tests as they relate to both the hypothesis and the world around you. When a researcher forms a hypothesis, this acts like a map through the research study. It tells the researcher which factors are important to study and how they might be related to each other or caused by a  manipulation  that the researcher introduces (e.g. a program, treatment or change in the environment). With this map, the researcher can interpret the information he/she collects and can make sound conclusions about the results.

Research can be done with human beings, animals, plants, other organisms and inorganic matter. When research is done with human beings and animals, it must follow specific rules about the treatment of humans and animals that have been created by the U.S. Federal Government. This ensures that humans and animals are treated with dignity and respect, and that the research causes minimal harm.

No matter what topic is being studied, the value of the research depends on how well it is designed and done. Therefore, one of the most important considerations in doing good research is to follow the design or plan that is developed by an experienced researcher who is called the  Principal Investigator  (PI). The PI is in charge of all aspects of the research and creates what is called a  protocol  (the research plan) that all people doing the research must follow. By doing so, the PI and the public can be sure that the results of the research are real and useful to other scientists.

Module 1: Discussion Questions

• How is a hypothesis like a road map?
• Who is ultimately responsible for the design and conduct of a research study?
• How does following the research protocol contribute to informing public health practices?

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Advanced Research Methods

• Writing a Research Proposal
• What Is Research?
• Library Research

What Is a Research Proposal?

Reference books.

• Writing the Research Paper
• Presenting the Research Paper

When applying for a research grant or scholarship, or, just before you start a major research project, you may be asked to write a preliminary document that includes basic information about your future research. This is the information that is usually needed in your proposal:

• The topic and goal of the research project.
• The kind of result expected from the research.
• The theory or framework in which the research will be done and presented.
• What kind of methods will be used (statistical, empirical, etc.).
• Short reference on the preliminary scholarship and why your research project is needed; how will it continue/justify/disprove the previous scholarship.
• How much will the research project cost; how will it be budgeted (what for the money will be spent).
• Why is it you who can do this research and not somebody else.

Most agencies that offer scholarships or grants provide information about the required format of the proposal. It may include filling out templates, types of information they need, suggested/maximum length of the proposal, etc.

Research proposal formats vary depending on the size of the planned research, the number of participants, the discipline, the characteristics of the research, etc. The following outline assumes an individual researcher. This is just a SAMPLE; several other ways are equally good and can be successful. If possible, discuss your research proposal with an expert in writing, a professor, your colleague, another student who already wrote successful proposals, etc.

• Author, author's affiliation
• Explain the topic and why you chose it. If possible explain your goal/outcome of the research . How much time you need to complete the research?
• Give a brief summary of previous scholarship and explain why your topic and goals are important.
• Relate your planned research to previous scholarship. What will your research add to our knowledge of the topic.
• Break down the main topic into smaller research questions. List them one by one and explain why these questions need to be investigated. Relate them to previous scholarship.
• Include your hypothesis into the descriptions of the detailed research issues if you have one. Explain why it is important to justify your hypothesis.
• This part depends of the methods conducted in the research process. List the methods; explain how the results will be presented; how they will be assessed.
• Explain what kind of results will justify or  disprove your hypothesis. 
• Explain how much money you need.
• Explain the details of the budget (how much you want to spend for what).
• Describe why your research is important.
• List the sources you have used for writing the research proposal, including a few main citations of the preliminary scholarship.

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What Is Research, and Why Do People Do It?

• Open Access
• First Online: 03 December 2022

Cite this chapter

You have full access to this open access chapter

• James Hiebert 6 ,
• Jinfa Cai 7 ,
• Stephen Hwang 7 ,
• Anne K Morris 6 &
• Charles Hohensee 6  

Part of the book series: Research in Mathematics Education ((RME))

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Abstractspiepr Abs1

Every day people do research as they gather information to learn about something of interest. In the scientific world, however, research means something different than simply gathering information. Scientific research is characterized by its careful planning and observing, by its relentless efforts to understand and explain, and by its commitment to learn from everyone else seriously engaged in research. We call this kind of research scientific inquiry and define it as “formulating, testing, and revising hypotheses.” By “hypotheses” we do not mean the hypotheses you encounter in statistics courses. We mean predictions about what you expect to find and rationales for why you made these predictions. Throughout this and the remaining chapters we make clear that the process of scientific inquiry applies to all kinds of research studies and data, both qualitative and quantitative.

You have full access to this open access chapter,  Download chapter PDF

Part I. What Is Research?

Have you ever studied something carefully because you wanted to know more about it? Maybe you wanted to know more about your grandmother’s life when she was younger so you asked her to tell you stories from her childhood, or maybe you wanted to know more about a fertilizer you were about to use in your garden so you read the ingredients on the package and looked them up online. According to the dictionary definition, you were doing research.

Recall your high school assignments asking you to “research” a topic. The assignment likely included consulting a variety of sources that discussed the topic, perhaps including some “original” sources. Often, the teacher referred to your product as a “research paper.”

Were you conducting research when you interviewed your grandmother or wrote high school papers reviewing a particular topic? Our view is that you were engaged in part of the research process, but only a small part. In this book, we reserve the word “research” for what it means in the scientific world, that is, for scientific research or, more pointedly, for scientific inquiry .

Exercise 1.1

Before you read any further, write a definition of what you think scientific inquiry is. Keep it short—Two to three sentences. You will periodically update this definition as you read this chapter and the remainder of the book.

This book is about scientific inquiry—what it is and how to do it. For starters, scientific inquiry is a process, a particular way of finding out about something that involves a number of phases. Each phase of the process constitutes one aspect of scientific inquiry. You are doing scientific inquiry as you engage in each phase, but you have not done scientific inquiry until you complete the full process. Each phase is necessary but not sufficient.

In this chapter, we set the stage by defining scientific inquiry—describing what it is and what it is not—and by discussing what it is good for and why people do it. The remaining chapters build directly on the ideas presented in this chapter.

A first thing to know is that scientific inquiry is not all or nothing. “Scientificness” is a continuum. Inquiries can be more scientific or less scientific. What makes an inquiry more scientific? You might be surprised there is no universally agreed upon answer to this question. None of the descriptors we know of are sufficient by themselves to define scientific inquiry. But all of them give you a way of thinking about some aspects of the process of scientific inquiry. Each one gives you different insights.

Exercise 1.2

As you read about each descriptor below, think about what would make an inquiry more or less scientific. If you think a descriptor is important, use it to revise your definition of scientific inquiry.

Creating an Image of Scientific Inquiry

We will present three descriptors of scientific inquiry. Each provides a different perspective and emphasizes a different aspect of scientific inquiry. We will draw on all three descriptors to compose our definition of scientific inquiry.

Descriptor 1. Experience Carefully Planned in Advance

Sir Ronald Fisher, often called the father of modern statistical design, once referred to research as “experience carefully planned in advance” (1935, p. 8). He said that humans are always learning from experience, from interacting with the world around them. Usually, this learning is haphazard rather than the result of a deliberate process carried out over an extended period of time. Research, Fisher said, was learning from experience, but experience carefully planned in advance.

This phrase can be fully appreciated by looking at each word. The fact that scientific inquiry is based on experience means that it is based on interacting with the world. These interactions could be thought of as the stuff of scientific inquiry. In addition, it is not just any experience that counts. The experience must be carefully planned . The interactions with the world must be conducted with an explicit, describable purpose, and steps must be taken to make the intended learning as likely as possible. This planning is an integral part of scientific inquiry; it is not just a preparation phase. It is one of the things that distinguishes scientific inquiry from many everyday learning experiences. Finally, these steps must be taken beforehand and the purpose of the inquiry must be articulated in advance of the experience. Clearly, scientific inquiry does not happen by accident, by just stumbling into something. Stumbling into something unexpected and interesting can happen while engaged in scientific inquiry, but learning does not depend on it and serendipity does not make the inquiry scientific.

Descriptor 2. Observing Something and Trying to Explain Why It Is the Way It Is

When we were writing this chapter and googled “scientific inquiry,” the first entry was: “Scientific inquiry refers to the diverse ways in which scientists study the natural world and propose explanations based on the evidence derived from their work.” The emphasis is on studying, or observing, and then explaining . This descriptor takes the image of scientific inquiry beyond carefully planned experience and includes explaining what was experienced.

According to the Merriam-Webster dictionary, “explain” means “(a) to make known, (b) to make plain or understandable, (c) to give the reason or cause of, and (d) to show the logical development or relations of” (Merriam-Webster, n.d. ). We will use all these definitions. Taken together, they suggest that to explain an observation means to understand it by finding reasons (or causes) for why it is as it is. In this sense of scientific inquiry, the following are synonyms: explaining why, understanding why, and reasoning about causes and effects. Our image of scientific inquiry now includes planning, observing, and explaining why.

We need to add a final note about this descriptor. We have phrased it in a way that suggests “observing something” means you are observing something in real time—observing the way things are or the way things are changing. This is often true. But, observing could mean observing data that already have been collected, maybe by someone else making the original observations (e.g., secondary analysis of NAEP data or analysis of existing video recordings of classroom instruction). We will address secondary analyses more fully in Chap. 4 . For now, what is important is that the process requires explaining why the data look like they do.

We must note that for us, the term “data” is not limited to numerical or quantitative data such as test scores. Data can also take many nonquantitative forms, including written survey responses, interview transcripts, journal entries, video recordings of students, teachers, and classrooms, text messages, and so forth.

Exercise 1.3

What are the implications of the statement that just “observing” is not enough to count as scientific inquiry? Does this mean that a detailed description of a phenomenon is not scientific inquiry?

Find sources that define research in education that differ with our position, that say description alone, without explanation, counts as scientific research. Identify the precise points where the opinions differ. What are the best arguments for each of the positions? Which do you prefer? Why?

Descriptor 3. Updating Everyone’s Thinking in Response to More and Better Information

This descriptor focuses on a third aspect of scientific inquiry: updating and advancing the field’s understanding of phenomena that are investigated. This descriptor foregrounds a powerful characteristic of scientific inquiry: the reliability (or trustworthiness) of what is learned and the ultimate inevitability of this learning to advance human understanding of phenomena. Humans might choose not to learn from scientific inquiry, but history suggests that scientific inquiry always has the potential to advance understanding and that, eventually, humans take advantage of these new understandings.

Before exploring these bold claims a bit further, note that this descriptor uses “information” in the same way the previous two descriptors used “experience” and “observations.” These are the stuff of scientific inquiry and we will use them often, sometimes interchangeably. Frequently, we will use the term “data” to stand for all these terms.

An overriding goal of scientific inquiry is for everyone to learn from what one scientist does. Much of this book is about the methods you need to use so others have faith in what you report and can learn the same things you learned. This aspect of scientific inquiry has many implications.

One implication is that scientific inquiry is not a private practice. It is a public practice available for others to see and learn from. Notice how different this is from everyday learning. When you happen to learn something from your everyday experience, often only you gain from the experience. The fact that research is a public practice means it is also a social one. It is best conducted by interacting with others along the way: soliciting feedback at each phase, taking opportunities to present work-in-progress, and benefitting from the advice of others.

A second implication is that you, as the researcher, must be committed to sharing what you are doing and what you are learning in an open and transparent way. This allows all phases of your work to be scrutinized and critiqued. This is what gives your work credibility. The reliability or trustworthiness of your findings depends on your colleagues recognizing that you have used all appropriate methods to maximize the chances that your claims are justified by the data.

A third implication of viewing scientific inquiry as a collective enterprise is the reverse of the second—you must be committed to receiving comments from others. You must treat your colleagues as fair and honest critics even though it might sometimes feel otherwise. You must appreciate their job, which is to remain skeptical while scrutinizing what you have done in considerable detail. To provide the best help to you, they must remain skeptical about your conclusions (when, for example, the data are difficult for them to interpret) until you offer a convincing logical argument based on the information you share. A rather harsh but good-to-remember statement of the role of your friendly critics was voiced by Karl Popper, a well-known twentieth century philosopher of science: “. . . if you are interested in the problem which I tried to solve by my tentative assertion, you may help me by criticizing it as severely as you can” (Popper, 1968, p. 27).

A final implication of this third descriptor is that, as someone engaged in scientific inquiry, you have no choice but to update your thinking when the data support a different conclusion. This applies to your own data as well as to those of others. When data clearly point to a specific claim, even one that is quite different than you expected, you must reconsider your position. If the outcome is replicated multiple times, you need to adjust your thinking accordingly. Scientific inquiry does not let you pick and choose which data to believe; it mandates that everyone update their thinking when the data warrant an update.

Doing Scientific Inquiry

We define scientific inquiry in an operational sense—what does it mean to do scientific inquiry? What kind of process would satisfy all three descriptors: carefully planning an experience in advance; observing and trying to explain what you see; and, contributing to updating everyone’s thinking about an important phenomenon?

We define scientific inquiry as formulating , testing , and revising hypotheses about phenomena of interest.

Of course, we are not the only ones who define it in this way. The definition for the scientific method posted by the editors of Britannica is: “a researcher develops a hypothesis, tests it through various means, and then modifies the hypothesis on the basis of the outcome of the tests and experiments” (Britannica, n.d. ).

Notice how defining scientific inquiry this way satisfies each of the descriptors. “Carefully planning an experience in advance” is exactly what happens when formulating a hypothesis about a phenomenon of interest and thinking about how to test it. “ Observing a phenomenon” occurs when testing a hypothesis, and “ explaining ” what is found is required when revising a hypothesis based on the data. Finally, “updating everyone’s thinking” comes from comparing publicly the original with the revised hypothesis.

Doing scientific inquiry, as we have defined it, underscores the value of accumulating knowledge rather than generating random bits of knowledge. Formulating, testing, and revising hypotheses is an ongoing process, with each revised hypothesis begging for another test, whether by the same researcher or by new researchers. The editors of Britannica signaled this cyclic process by adding the following phrase to their definition of the scientific method: “The modified hypothesis is then retested, further modified, and tested again.” Scientific inquiry creates a process that encourages each study to build on the studies that have gone before. Through collective engagement in this process of building study on top of study, the scientific community works together to update its thinking.

Before exploring more fully the meaning of “formulating, testing, and revising hypotheses,” we need to acknowledge that this is not the only way researchers define research. Some researchers prefer a less formal definition, one that includes more serendipity, less planning, less explanation. You might have come across more open definitions such as “research is finding out about something.” We prefer the tighter hypothesis formulation, testing, and revision definition because we believe it provides a single, coherent map for conducting research that addresses many of the thorny problems educational researchers encounter. We believe it is the most useful orientation toward research and the most helpful to learn as a beginning researcher.

A final clarification of our definition is that it applies equally to qualitative and quantitative research. This is a familiar distinction in education that has generated much discussion. You might think our definition favors quantitative methods over qualitative methods because the language of hypothesis formulation and testing is often associated with quantitative methods. In fact, we do not favor one method over another. In Chap. 4 , we will illustrate how our definition fits research using a range of quantitative and qualitative methods.

Exercise 1.4

Look for ways to extend what the field knows in an area that has already received attention by other researchers. Specifically, you can search for a program of research carried out by more experienced researchers that has some revised hypotheses that remain untested. Identify a revised hypothesis that you might like to test.

Unpacking the Terms Formulating, Testing, and Revising Hypotheses

To get a full sense of the definition of scientific inquiry we will use throughout this book, it is helpful to spend a little time with each of the key terms.

We first want to make clear that we use the term “hypothesis” as it is defined in most dictionaries and as it used in many scientific fields rather than as it is usually defined in educational statistics courses. By “hypothesis,” we do not mean a null hypothesis that is accepted or rejected by statistical analysis. Rather, we use “hypothesis” in the sense conveyed by the following definitions: “An idea or explanation for something that is based on known facts but has not yet been proved” (Cambridge University Press, n.d. ), and “An unproved theory, proposition, or supposition, tentatively accepted to explain certain facts and to provide a basis for further investigation or argument” (Agnes & Guralnik, 2008 ).

We distinguish two parts to “hypotheses.” Hypotheses consist of predictions and rationales . Predictions are statements about what you expect to find when you inquire about something. Rationales are explanations for why you made the predictions you did, why you believe your predictions are correct. So, for us “formulating hypotheses” means making explicit predictions and developing rationales for the predictions.

“Testing hypotheses” means making observations that allow you to assess in what ways your predictions were correct and in what ways they were incorrect. In education research, it is rarely useful to think of your predictions as either right or wrong. Because of the complexity of most issues you will investigate, most predictions will be right in some ways and wrong in others.

By studying the observations you make (data you collect) to test your hypotheses, you can revise your hypotheses to better align with the observations. This means revising your predictions plus revising your rationales to justify your adjusted predictions. Even though you might not run another test, formulating revised hypotheses is an essential part of conducting a research study. Comparing your original and revised hypotheses informs everyone of what you learned by conducting your study. In addition, a revised hypothesis sets the stage for you or someone else to extend your study and accumulate more knowledge of the phenomenon.

We should note that not everyone makes a clear distinction between predictions and rationales as two aspects of hypotheses. In fact, common, non-scientific uses of the word “hypothesis” may limit it to only a prediction or only an explanation (or rationale). We choose to explicitly include both prediction and rationale in our definition of hypothesis, not because we assert this should be the universal definition, but because we want to foreground the importance of both parts acting in concert. Using “hypothesis” to represent both prediction and rationale could hide the two aspects, but we make them explicit because they provide different kinds of information. It is usually easier to make predictions than develop rationales because predictions can be guesses, hunches, or gut feelings about which you have little confidence. Developing a compelling rationale requires careful thought plus reading what other researchers have found plus talking with your colleagues. Often, while you are developing your rationale you will find good reasons to change your predictions. Developing good rationales is the engine that drives scientific inquiry. Rationales are essentially descriptions of how much you know about the phenomenon you are studying. Throughout this guide, we will elaborate on how developing good rationales drives scientific inquiry. For now, we simply note that it can sharpen your predictions and help you to interpret your data as you test your hypotheses.

Hypotheses in education research take a variety of forms or types. This is because there are a variety of phenomena that can be investigated. Investigating educational phenomena is sometimes best done using qualitative methods, sometimes using quantitative methods, and most often using mixed methods (e.g., Hay, 2016 ; Weis et al. 2019a ; Weisner, 2005 ). This means that, given our definition, hypotheses are equally applicable to qualitative and quantitative investigations.

Hypotheses take different forms when they are used to investigate different kinds of phenomena. Two very different activities in education could be labeled conducting experiments and descriptions. In an experiment, a hypothesis makes a prediction about anticipated changes, say the changes that occur when a treatment or intervention is applied. You might investigate how students’ thinking changes during a particular kind of instruction.

A second type of hypothesis, relevant for descriptive research, makes a prediction about what you will find when you investigate and describe the nature of a situation. The goal is to understand a situation as it exists rather than to understand a change from one situation to another. In this case, your prediction is what you expect to observe. Your rationale is the set of reasons for making this prediction; it is your current explanation for why the situation will look like it does.

You will probably read, if you have not already, that some researchers say you do not need a prediction to conduct a descriptive study. We will discuss this point of view in Chap. 2 . For now, we simply claim that scientific inquiry, as we have defined it, applies to all kinds of research studies. Descriptive studies, like others, not only benefit from formulating, testing, and revising hypotheses, but also need hypothesis formulating, testing, and revising.

One reason we define research as formulating, testing, and revising hypotheses is that if you think of research in this way you are less likely to go wrong. It is a useful guide for the entire process, as we will describe in detail in the chapters ahead. For example, as you build the rationale for your predictions, you are constructing the theoretical framework for your study (Chap. 3 ). As you work out the methods you will use to test your hypothesis, every decision you make will be based on asking, “Will this help me formulate or test or revise my hypothesis?” (Chap. 4 ). As you interpret the results of testing your predictions, you will compare them to what you predicted and examine the differences, focusing on how you must revise your hypotheses (Chap. 5 ). By anchoring the process to formulating, testing, and revising hypotheses, you will make smart decisions that yield a coherent and well-designed study.

Exercise 1.5

Compare the concept of formulating, testing, and revising hypotheses with the descriptions of scientific inquiry contained in Scientific Research in Education (NRC, 2002 ). How are they similar or different?

Exercise 1.6

Provide an example to illustrate and emphasize the differences between everyday learning/thinking and scientific inquiry.

Learning from Doing Scientific Inquiry

We noted earlier that a measure of what you have learned by conducting a research study is found in the differences between your original hypothesis and your revised hypothesis based on the data you collected to test your hypothesis. We will elaborate this statement in later chapters, but we preview our argument here.

Even before collecting data, scientific inquiry requires cycles of making a prediction, developing a rationale, refining your predictions, reading and studying more to strengthen your rationale, refining your predictions again, and so forth. And, even if you have run through several such cycles, you still will likely find that when you test your prediction you will be partly right and partly wrong. The results will support some parts of your predictions but not others, or the results will “kind of” support your predictions. A critical part of scientific inquiry is making sense of your results by interpreting them against your predictions. Carefully describing what aspects of your data supported your predictions, what aspects did not, and what data fell outside of any predictions is not an easy task, but you cannot learn from your study without doing this analysis.

Analyzing the matches and mismatches between your predictions and your data allows you to formulate different rationales that would have accounted for more of the data. The best revised rationale is the one that accounts for the most data. Once you have revised your rationales, you can think about the predictions they best justify or explain. It is by comparing your original rationales to your new rationales that you can sort out what you learned from your study.

Suppose your study was an experiment. Maybe you were investigating the effects of a new instructional intervention on students’ learning. Your original rationale was your explanation for why the intervention would change the learning outcomes in a particular way. Your revised rationale explained why the changes that you observed occurred like they did and why your revised predictions are better. Maybe your original rationale focused on the potential of the activities if they were implemented in ideal ways and your revised rationale included the factors that are likely to affect how teachers implement them. By comparing the before and after rationales, you are describing what you learned—what you can explain now that you could not before. Another way of saying this is that you are describing how much more you understand now than before you conducted your study.

Revised predictions based on carefully planned and collected data usually exhibit some of the following features compared with the originals: more precision, more completeness, and broader scope. Revised rationales have more explanatory power and become more complete, more aligned with the new predictions, sharper, and overall more convincing.

Part II. Why Do Educators Do Research?

Doing scientific inquiry is a lot of work. Each phase of the process takes time, and you will often cycle back to improve earlier phases as you engage in later phases. Because of the significant effort required, you should make sure your study is worth it. So, from the beginning, you should think about the purpose of your study. Why do you want to do it? And, because research is a social practice, you should also think about whether the results of your study are likely to be important and significant to the education community.

If you are doing research in the way we have described—as scientific inquiry—then one purpose of your study is to understand , not just to describe or evaluate or report. As we noted earlier, when you formulate hypotheses, you are developing rationales that explain why things might be like they are. In our view, trying to understand and explain is what separates research from other kinds of activities, like evaluating or describing.

One reason understanding is so important is that it allows researchers to see how or why something works like it does. When you see how something works, you are better able to predict how it might work in other contexts, under other conditions. And, because conditions, or contextual factors, matter a lot in education, gaining insights into applying your findings to other contexts increases the contributions of your work and its importance to the broader education community.

Consequently, the purposes of research studies in education often include the more specific aim of identifying and understanding the conditions under which the phenomena being studied work like the observations suggest. A classic example of this kind of study in mathematics education was reported by William Brownell and Harold Moser in 1949 . They were trying to establish which method of subtracting whole numbers could be taught most effectively—the regrouping method or the equal additions method. However, they realized that effectiveness might depend on the conditions under which the methods were taught—“meaningfully” versus “mechanically.” So, they designed a study that crossed the two instructional approaches with the two different methods (regrouping and equal additions). Among other results, they found that these conditions did matter. The regrouping method was more effective under the meaningful condition than the mechanical condition, but the same was not true for the equal additions algorithm.

What do education researchers want to understand? In our view, the ultimate goal of education is to offer all students the best possible learning opportunities. So, we believe the ultimate purpose of scientific inquiry in education is to develop understanding that supports the improvement of learning opportunities for all students. We say “ultimate” because there are lots of issues that must be understood to improve learning opportunities for all students. Hypotheses about many aspects of education are connected, ultimately, to students’ learning. For example, formulating and testing a hypothesis that preservice teachers need to engage in particular kinds of activities in their coursework in order to teach particular topics well is, ultimately, connected to improving students’ learning opportunities. So is hypothesizing that school districts often devote relatively few resources to instructional leadership training or hypothesizing that positioning mathematics as a tool students can use to combat social injustice can help students see the relevance of mathematics to their lives.

We do not exclude the importance of research on educational issues more removed from improving students’ learning opportunities, but we do think the argument for their importance will be more difficult to make. If there is no way to imagine a connection between your hypothesis and improving learning opportunities for students, even a distant connection, we recommend you reconsider whether it is an important hypothesis within the education community.

Notice that we said the ultimate goal of education is to offer all students the best possible learning opportunities. For too long, educators have been satisfied with a goal of offering rich learning opportunities for lots of students, sometimes even for just the majority of students, but not necessarily for all students. Evaluations of success often are based on outcomes that show high averages. In other words, if many students have learned something, or even a smaller number have learned a lot, educators may have been satisfied. The problem is that there is usually a pattern in the groups of students who receive lower quality opportunities—students of color and students who live in poor areas, urban and rural. This is not acceptable. Consequently, we emphasize the premise that the purpose of education research is to offer rich learning opportunities to all students.

One way to make sure you will be able to convince others of the importance of your study is to consider investigating some aspect of teachers’ shared instructional problems. Historically, researchers in education have set their own research agendas, regardless of the problems teachers are facing in schools. It is increasingly recognized that teachers have had trouble applying to their own classrooms what researchers find. To address this problem, a researcher could partner with a teacher—better yet, a small group of teachers—and talk with them about instructional problems they all share. These discussions can create a rich pool of problems researchers can consider. If researchers pursued one of these problems (preferably alongside teachers), the connection to improving learning opportunities for all students could be direct and immediate. “Grounding a research question in instructional problems that are experienced across multiple teachers’ classrooms helps to ensure that the answer to the question will be of sufficient scope to be relevant and significant beyond the local context” (Cai et al., 2019b , p. 115).

As a beginning researcher, determining the relevance and importance of a research problem is especially challenging. We recommend talking with advisors, other experienced researchers, and peers to test the educational importance of possible research problems and topics of study. You will also learn much more about the issue of research importance when you read Chap. 5 .

Exercise 1.7

Identify a problem in education that is closely connected to improving learning opportunities and a problem that has a less close connection. For each problem, write a brief argument (like a logical sequence of if-then statements) that connects the problem to all students’ learning opportunities.

Part III. Conducting Research as a Practice of Failing Productively

Scientific inquiry involves formulating hypotheses about phenomena that are not fully understood—by you or anyone else. Even if you are able to inform your hypotheses with lots of knowledge that has already been accumulated, you are likely to find that your prediction is not entirely accurate. This is normal. Remember, scientific inquiry is a process of constantly updating your thinking. More and better information means revising your thinking, again, and again, and again. Because you never fully understand a complicated phenomenon and your hypotheses never produce completely accurate predictions, it is easy to believe you are somehow failing.

The trick is to fail upward, to fail to predict accurately in ways that inform your next hypothesis so you can make a better prediction. Some of the best-known researchers in education have been open and honest about the many times their predictions were wrong and, based on the results of their studies and those of others, they continuously updated their thinking and changed their hypotheses.

A striking example of publicly revising (actually reversing) hypotheses due to incorrect predictions is found in the work of Lee J. Cronbach, one of the most distinguished educational psychologists of the twentieth century. In 1955, Cronbach delivered his presidential address to the American Psychological Association. Titling it “Two Disciplines of Scientific Psychology,” Cronbach proposed a rapprochement between two research approaches—correlational studies that focused on individual differences and experimental studies that focused on instructional treatments controlling for individual differences. (We will examine different research approaches in Chap. 4 ). If these approaches could be brought together, reasoned Cronbach ( 1957 ), researchers could find interactions between individual characteristics and treatments (aptitude-treatment interactions or ATIs), fitting the best treatments to different individuals.

In 1975, after years of research by many researchers looking for ATIs, Cronbach acknowledged the evidence for simple, useful ATIs had not been found. Even when trying to find interactions between a few variables that could provide instructional guidance, the analysis, said Cronbach, creates “a hall of mirrors that extends to infinity, tormenting even the boldest investigators and defeating even ambitious designs” (Cronbach, 1975 , p. 119).

As he was reflecting back on his work, Cronbach ( 1986 ) recommended moving away from documenting instructional effects through statistical inference (an approach he had championed for much of his career) and toward approaches that probe the reasons for these effects, approaches that provide a “full account of events in a time, place, and context” (Cronbach, 1986 , p. 104). This is a remarkable change in hypotheses, a change based on data and made fully transparent. Cronbach understood the value of failing productively.

Closer to home, in a less dramatic example, one of us began a line of scientific inquiry into how to prepare elementary preservice teachers to teach early algebra. Teaching early algebra meant engaging elementary students in early forms of algebraic reasoning. Such reasoning should help them transition from arithmetic to algebra. To begin this line of inquiry, a set of activities for preservice teachers were developed. Even though the activities were based on well-supported hypotheses, they largely failed to engage preservice teachers as predicted because of unanticipated challenges the preservice teachers faced. To capitalize on this failure, follow-up studies were conducted, first to better understand elementary preservice teachers’ challenges with preparing to teach early algebra, and then to better support preservice teachers in navigating these challenges. In this example, the initial failure was a necessary step in the researchers’ scientific inquiry and furthered the researchers’ understanding of this issue.

We present another example of failing productively in Chap. 2 . That example emerges from recounting the history of a well-known research program in mathematics education.

Making mistakes is an inherent part of doing scientific research. Conducting a study is rarely a smooth path from beginning to end. We recommend that you keep the following things in mind as you begin a career of conducting research in education.

First, do not get discouraged when you make mistakes; do not fall into the trap of feeling like you are not capable of doing research because you make too many errors.

Second, learn from your mistakes. Do not ignore your mistakes or treat them as errors that you simply need to forget and move past. Mistakes are rich sites for learning—in research just as in other fields of study.

Third, by reflecting on your mistakes, you can learn to make better mistakes, mistakes that inform you about a productive next step. You will not be able to eliminate your mistakes, but you can set a goal of making better and better mistakes.

Exercise 1.8

How does scientific inquiry differ from everyday learning in giving you the tools to fail upward? You may find helpful perspectives on this question in other resources on science and scientific inquiry (e.g., Failure: Why Science is So Successful by Firestein, 2015).

Exercise 1.9

Use what you have learned in this chapter to write a new definition of scientific inquiry. Compare this definition with the one you wrote before reading this chapter. If you are reading this book as part of a course, compare your definition with your colleagues’ definitions. Develop a consensus definition with everyone in the course.

Part IV. Preview of Chap. 2

Now that you have a good idea of what research is, at least of what we believe research is, the next step is to think about how to actually begin doing research. This means how to begin formulating, testing, and revising hypotheses. As for all phases of scientific inquiry, there are lots of things to think about. Because it is critical to start well, we devote Chap. 2 to getting started with formulating hypotheses.

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Hiebert, J., Cai, J., Hwang, S., Morris, A.K., Hohensee, C. (2023). What Is Research, and Why Do People Do It?. In: Doing Research: A New Researcher’s Guide. Research in Mathematics Education. Springer, Cham. https://doi.org/10.1007/978-3-031-19078-0_1

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Advance Care Planning Frequently Asked Questions

Does talking about end of life mean it will happen sooner?

Nobody knows how today will end or what will happen tomorrow. Therefore, it is important for everyone to have a plan for when it is needed.

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After you have had the conversation , it is important to document it. Your wishes can be documented by creating an advance care plan .

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I don’t want to burden my family with having to make decisions for me.

Caring for others is what families do. Sometimes part of that caring involves making decisions. End-of-life decisions can be difficult, and an advance care plan is one way to ease some of the decision-making burden. A person’s wishes are communicated in an advance care plan. It is the role of the power of attorney to express those wishes after the decision has already been made about end-of-life treatments.

When is the right time to complete an advance care plan?

Anyone over the age of 18 can create an advance care plan. As a person ages, it is a good idea to consider end-of-life treatment options. It is never too early to create one.

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Your health care team generally will follow your health care directive or any instructions from your agent, as long as the health care follows reasonable medical practice. You should inform others of your health care documents and give people copies of them. You may wish to inform family members, your health care agent or agents, and your health care team that you have health care documents. You should give them a copy. It’s a good idea to review and update your directive as your needs change. Keep it in a safe place where it can be easily found.

How should I make decisions about my health care?

It is most important that you think about what is best for you and not what your family, friends or doctors would want for you. Decision-making should be aligned with your values. Your values are what is most important to you and what gives your life meaning. If your values would be threatened with treatments, what would quality of life look like for you?

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If a person can no longer communicate his or her wishes, it is too late to complete an advance care plan. Contact the patient's primary care provider with questions.

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Advance care plan documents can be obtained by contacting your local hospital social work department or contacting your primary care professional's office. You also can obtain the form on the Create It page .

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What is Scientific Research and How Can it be Done?

Scientific researches are studies that should be systematically planned before performing them. In this review, classification and description of scientific studies, planning stage randomisation and bias are explained.

Research conducted for the purpose of contributing towards science by the systematic collection, interpretation and evaluation of data and that, too, in a planned manner is called scientific research: a researcher is the one who conducts this research. The results obtained from a small group through scientific studies are socialised, and new information is revealed with respect to diagnosis, treatment and reliability of applications. The purpose of this review is to provide information about the definition, classification and methodology of scientific research.

Before beginning the scientific research, the researcher should determine the subject, do planning and specify the methodology. In the Declaration of Helsinki, it is stated that ‘the primary purpose of medical researches on volunteers is to understand the reasons, development and effects of diseases and develop protective, diagnostic and therapeutic interventions (method, operation and therapies). Even the best proven interventions should be evaluated continuously by investigations with regard to reliability, effectiveness, efficiency, accessibility and quality’ ( 1 ).

The questions, methods of response to questions and difficulties in scientific research may vary, but the design and structure are generally the same ( 2 ).

Classification of Scientific Research

Scientific research can be classified in several ways. Classification can be made according to the data collection techniques based on causality, relationship with time and the medium through which they are applied.

• Observational
• Experimental
• Descriptive
• Retrospective
• Prospective
• Cross-sectional
• Social descriptive research ( 3 )

Another method is to classify the research according to its descriptive or analytical features. This review is written according to this classification method.

I. Descriptive research

• Case series
• Surveillance studies

II. Analytical research

• Observational studies: cohort, case control and cross- sectional research
• Interventional research: quasi-experimental and clinical research
• Case Report: it is the most common type of descriptive study. It is the examination of a single case having a different quality in the society, e.g. conducting general anaesthesia in a pregnant patient with mucopolysaccharidosis.
• Case Series: it is the description of repetitive cases having common features. For instance; case series involving interscapular pain related to neuraxial labour analgesia. Interestingly, malignant hyperthermia cases are not accepted as case series since they are rarely seen during historical development.
• Surveillance Studies: these are the results obtained from the databases that follow and record a health problem for a certain time, e.g. the surveillance of cross-infections during anaesthesia in the intensive care unit.

Moreover, some studies may be experimental. After the researcher intervenes, the researcher waits for the result, observes and obtains data. Experimental studies are, more often, in the form of clinical trials or laboratory animal trials ( 2 ).

Analytical observational research can be classified as cohort, case-control and cross-sectional studies.

Firstly, the participants are controlled with regard to the disease under investigation. Patients are excluded from the study. Healthy participants are evaluated with regard to the exposure to the effect. Then, the group (cohort) is followed-up for a sufficient period of time with respect to the occurrence of disease, and the progress of disease is studied. The risk of the healthy participants getting sick is considered an incident. In cohort studies, the risk of disease between the groups exposed and not exposed to the effect is calculated and rated. This rate is called relative risk. Relative risk indicates the strength of exposure to the effect on the disease.

Cohort research may be observational and experimental. The follow-up of patients prospectively is called a prospective cohort study . The results are obtained after the research starts. The researcher’s following-up of cohort subjects from a certain point towards the past is called a retrospective cohort study . Prospective cohort studies are more valuable than retrospective cohort studies: this is because in the former, the researcher observes and records the data. The researcher plans the study before the research and determines what data will be used. On the other hand, in retrospective studies, the research is made on recorded data: no new data can be added.

In fact, retrospective and prospective studies are not observational. They determine the relationship between the date on which the researcher has begun the study and the disease development period. The most critical disadvantage of this type of research is that if the follow-up period is long, participants may leave the study at their own behest or due to physical conditions. Cohort studies that begin after exposure and before disease development are called ambidirectional studies . Public healthcare studies generally fall within this group, e.g. lung cancer development in smokers.

• Case-Control Studies: these studies are retrospective cohort studies. They examine the cause and effect relationship from the effect to the cause. The detection or determination of data depends on the information recorded in the past. The researcher has no control over the data ( 2 ).

Cross-sectional studies are advantageous since they can be concluded relatively quickly. It may be difficult to obtain a reliable result from such studies for rare diseases ( 2 ).

Cross-sectional studies are characterised by timing. In such studies, the exposure and result are simultaneously evaluated. While cross-sectional studies are restrictedly used in studies involving anaesthesia (since the process of exposure is limited), they can be used in studies conducted in intensive care units.

• Quasi-Experimental Research: they are conducted in cases in which a quick result is requested and the participants or research areas cannot be randomised, e.g. giving hand-wash training and comparing the frequency of nosocomial infections before and after hand wash.
• Clinical Research: they are prospective studies carried out with a control group for the purpose of comparing the effect and value of an intervention in a clinical case. Clinical study and research have the same meaning. Drugs, invasive interventions, medical devices and operations, diets, physical therapy and diagnostic tools are relevant in this context ( 6 ).

Clinical studies are conducted by a responsible researcher, generally a physician. In the research team, there may be other healthcare staff besides physicians. Clinical studies may be financed by healthcare institutes, drug companies, academic medical centres, volunteer groups, physicians, healthcare service providers and other individuals. They may be conducted in several places including hospitals, universities, physicians’ offices and community clinics based on the researcher’s requirements. The participants are made aware of the duration of the study before their inclusion. Clinical studies should include the evaluation of recommendations (drug, device and surgical) for the treatment of a disease, syndrome or a comparison of one or more applications; finding different ways for recognition of a disease or case and prevention of their recurrence ( 7 ).

Clinical Research

In this review, clinical research is explained in more detail since it is the most valuable study in scientific research.

Clinical research starts with forming a hypothesis. A hypothesis can be defined as a claim put forward about the value of a population parameter based on sampling. There are two types of hypotheses in statistics.

• H 0 hypothesis is called a control or null hypothesis. It is the hypothesis put forward in research, which implies that there is no difference between the groups under consideration. If this hypothesis is rejected at the end of the study, it indicates that a difference exists between the two treatments under consideration.
• H 1 hypothesis is called an alternative hypothesis. It is hypothesised against a null hypothesis, which implies that a difference exists between the groups under consideration. For example, consider the following hypothesis: drug A has an analgesic effect. Control or null hypothesis (H 0 ): there is no difference between drug A and placebo with regard to the analgesic effect. The alternative hypothesis (H 1 ) is applicable if a difference exists between drug A and placebo with regard to the analgesic effect.

The planning phase comes after the determination of a hypothesis. A clinical research plan is called a protocol . In a protocol, the reasons for research, number and qualities of participants, tests to be applied, study duration and what information to be gathered from the participants should be found and conformity criteria should be developed.

The selection of participant groups to be included in the study is important. Inclusion and exclusion criteria of the study for the participants should be determined. Inclusion criteria should be defined in the form of demographic characteristics (age, gender, etc.) of the participant group and the exclusion criteria as the diseases that may influence the study, age ranges, cases involving pregnancy and lactation, continuously used drugs and participants’ cooperation.

The next stage is methodology. Methodology can be grouped under subheadings, namely, the calculation of number of subjects, blinding (masking), randomisation, selection of operation to be applied, use of placebo and criteria for stopping and changing the treatment.

I. Calculation of the Number of Subjects

The entire source from which the data are obtained is called a universe or population . A small group selected from a certain universe based on certain rules and which is accepted to highly represent the universe from which it is selected is called a sample and the characteristics of the population from which the data are collected are called variables. If data is collected from the entire population, such an instance is called a parameter . Conducting a study on the sample rather than the entire population is easier and less costly. Many factors influence the determination of the sample size. Firstly, the type of variable should be determined. Variables are classified as categorical (qualitative, non-numerical) or numerical (quantitative). Individuals in categorical variables are classified according to their characteristics. Categorical variables are indicated as nominal and ordinal (ordered). In nominal variables, the application of a category depends on the researcher’s preference. For instance, a female participant can be considered first and then the male participant, or vice versa. An ordinal (ordered) variable is ordered from small to large or vice versa (e.g. ordering obese patients based on their weights-from the lightest to the heaviest or vice versa). A categorical variable may have more than one characteristic: such variables are called binary or dichotomous (e.g. a participant may be both female and obese).

If the variable has numerical (quantitative) characteristics and these characteristics cannot be categorised, then it is called a numerical variable. Numerical variables are either discrete or continuous. For example, the number of operations with spinal anaesthesia represents a discrete variable. The haemoglobin value or height represents a continuous variable.

Statistical analyses that need to be employed depend on the type of variable. The determination of variables is necessary for selecting the statistical method as well as software in SPSS. While categorical variables are presented as numbers and percentages, numerical variables are represented using measures such as mean and standard deviation. It may be necessary to use mean in categorising some cases such as the following: even though the variable is categorical (qualitative, non-numerical) when Visual Analogue Scale (VAS) is used (since a numerical value is obtained), it is classified as a numerical variable: such variables are averaged.

Clinical research is carried out on the sample and generalised to the population. Accordingly, the number of samples should be correctly determined. Different sample size formulas are used on the basis of the statistical method to be used. When the sample size increases, error probability decreases. The sample size is calculated based on the primary hypothesis. The determination of a sample size before beginning the research specifies the power of the study. Power analysis enables the acquisition of realistic results in the research, and it is used for comparing two or more clinical research methods.

Because of the difference in the formulas used in calculating power analysis and number of samples for clinical research, it facilitates the use of computer programs for making calculations.

It is necessary to know certain parameters in order to calculate the number of samples by power analysis.

• Type-I (α) and type-II (β) error levels
• Difference between groups (d-difference) and effect size (ES)
• Distribution ratio of groups
• Direction of research hypothesis (H1)

a. Type-I (α) and Type-II (β) Error (β) Levels

Two types of errors can be made while accepting or rejecting H 0 hypothesis in a hypothesis test. Type-I error (α) level is the probability of finding a difference at the end of the research when there is no difference between the two applications. In other words, it is the rejection of the hypothesis when H 0 is actually correct and it is known as α error or p value. For instance, when the size is determined, type-I error level is accepted as 0.05 or 0.01.

Another error that can be made during a hypothesis test is a type-II error. It is the acceptance of a wrongly hypothesised H 0 hypothesis. In fact, it is the probability of failing to find a difference when there is a difference between the two applications. The power of a test is the ability of that test to find a difference that actually exists. Therefore, it is related to the type-II error level.

Since the type-II error risk is expressed as β, the power of the test is defined as 1–β. When a type-II error is 0.20, the power of the test is 0.80. Type-I (α) and type-II (β) errors can be intentional. The reason to intentionally make such an error is the necessity to look at the events from the opposite perspective.

b. Difference between Groups and ES

ES is defined as the state in which statistical difference also has clinically significance: ES≥0.5 is desirable. The difference between groups is the absolute difference between the groups compared in clinical research.

c. Allocation Ratio of Groups

The allocation ratio of groups is effective in determining the number of samples. If the number of samples is desired to be determined at the lowest level, the rate should be kept as 1/1.

d. Direction of Hypothesis (H1)

The direction of hypothesis in clinical research may be one-sided or two-sided. While one-sided hypotheses hypothesis test differences in the direction of size, two-sided hypotheses hypothesis test differences without direction. The power of the test in two-sided hypotheses is lower than one-sided hypotheses.

After these four variables are determined, they are entered in the appropriate computer program and the number of samples is calculated. Statistical packaged software programs such as Statistica, NCSS and G-Power may be used for power analysis and calculating the number of samples. When the samples size is calculated, if there is a decrease in α, difference between groups, ES and number of samples, then the standard deviation increases and power decreases. The power in two-sided hypothesis is lower. It is ethically appropriate to consider the determination of sample size, particularly in animal experiments, at the beginning of the study. The phase of the study is also important in the determination of number of subjects to be included in drug studies. Usually, phase-I studies are used to determine the safety profile of a drug or product, and they are generally conducted on a few healthy volunteers. If no unacceptable toxicity is detected during phase-I studies, phase-II studies may be carried out. Phase-II studies are proof-of-concept studies conducted on a larger number (100–500) of volunteer patients. When the effectiveness of the drug or product is evident in phase-II studies, phase-III studies can be initiated. These are randomised, double-blinded, placebo or standard treatment-controlled studies. Volunteer patients are periodically followed-up with respect to the effectiveness and side effects of the drug. It can generally last 1–4 years and is valuable during licensing and releasing the drug to the general market. Then, phase-IV studies begin in which long-term safety is investigated (indication, dose, mode of application, safety, effectiveness, etc.) on thousands of volunteer patients.

II. Blinding (Masking) and Randomisation Methods

When the methodology of clinical research is prepared, precautions should be taken to prevent taking sides. For this reason, techniques such as randomisation and blinding (masking) are used. Comparative studies are the most ideal ones in clinical research.

Blinding Method

A case in which the treatments applied to participants of clinical research should be kept unknown is called the blinding method . If the participant does not know what it receives, it is called a single-blind study; if even the researcher does not know, it is called a double-blind study. When there is a probability of knowing which drug is given in the order of application, when uninformed staff administers the drug, it is called in-house blinding. In case the study drug is known in its pharmaceutical form, a double-dummy blinding test is conducted. Intravenous drug is given to one group and a placebo tablet is given to the comparison group; then, the placebo tablet is given to the group that received the intravenous drug and intravenous drug in addition to placebo tablet is given to the comparison group. In this manner, each group receives both the intravenous and tablet forms of the drug. In case a third party interested in the study is involved and it also does not know about the drug (along with the statistician), it is called third-party blinding.

Randomisation Method

The selection of patients for the study groups should be random. Randomisation methods are used for such selection, which prevent conscious or unconscious manipulations in the selection of patients ( 8 ).

No factor pertaining to the patient should provide preference of one treatment to the other during randomisation. This characteristic is the most important difference separating randomised clinical studies from prospective and synchronous studies with experimental groups. Randomisation strengthens the study design and enables the determination of reliable scientific knowledge ( 2 ).

The easiest method is simple randomisation, e.g. determination of the type of anaesthesia to be administered to a patient by tossing a coin. In this method, when the number of samples is kept high, a balanced distribution is created. When the number of samples is low, there will be an imbalance between the groups. In this case, stratification and blocking have to be added to randomisation. Stratification is the classification of patients one or more times according to prognostic features determined by the researcher and blocking is the selection of a certain number of patients for each stratification process. The number of stratification processes should be determined at the beginning of the study.

As the number of stratification processes increases, performing the study and balancing the groups become difficult. For this reason, stratification characteristics and limitations should be effectively determined at the beginning of the study. It is not mandatory for the stratifications to have equal intervals. Despite all the precautions, an imbalance might occur between the groups before beginning the research. In such circumstances, post-stratification or restandardisation may be conducted according to the prognostic factors.

The main characteristic of applying blinding (masking) and randomisation is the prevention of bias. Therefore, it is worthwhile to comprehensively examine bias at this stage.

Bias and Chicanery

While conducting clinical research, errors can be introduced voluntarily or involuntarily at a number of stages, such as design, population selection, calculating the number of samples, non-compliance with study protocol, data entry and selection of statistical method. Bias is taking sides of individuals in line with their own decisions, views and ideological preferences ( 9 ). In order for an error to lead to bias, it has to be a systematic error. Systematic errors in controlled studies generally cause the results of one group to move in a different direction as compared to the other. It has to be understood that scientific research is generally prone to errors. However, random errors (or, in other words, ‘the luck factor’-in which bias is unintended-do not lead to bias ( 10 ).

Another issue, which is different from bias, is chicanery. It is defined as voluntarily changing the interventions, results and data of patients in an unethical manner or copying data from other studies. Comparatively, bias may not be done consciously.

In case unexpected results or outliers are found while the study is analysed, if possible, such data should be re-included into the study since the complete exclusion of data from a study endangers its reliability. In such a case, evaluation needs to be made with and without outliers. It is insignificant if no difference is found. However, if there is a difference, the results with outliers are re-evaluated. If there is no error, then the outlier is included in the study (as the outlier may be a result). It should be noted that re-evaluation of data in anaesthesiology is not possible.

Statistical evaluation methods should be determined at the design stage so as not to encounter unexpected results in clinical research. The data should be evaluated before the end of the study and without entering into details in research that are time-consuming and involve several samples. This is called an interim analysis . The date of interim analysis should be determined at the beginning of the study. The purpose of making interim analysis is to prevent unnecessary cost and effort since it may be necessary to conclude the research after the interim analysis, e.g. studies in which there is no possibility to validate the hypothesis at the end or the occurrence of different side effects of the drug to be used. The accuracy of the hypothesis and number of samples are compared. Statistical significance levels in interim analysis are very important. If the data level is significant, the hypothesis is validated even if the result turns out to be insignificant after the date of the analysis.

Another important point to be considered is the necessity to conclude the participants’ treatment within the period specified in the study protocol. When the result of the study is achieved earlier and unexpected situations develop, the treatment is concluded earlier. Moreover, the participant may quit the study at its own behest, may die or unpredictable situations (e.g. pregnancy) may develop. The participant can also quit the study whenever it wants, even if the study has not ended ( 7 ).

In case the results of a study are contrary to already known or expected results, the expected quality level of the study suggesting the contradiction may be higher than the studies supporting what is known in that subject. This type of bias is called confirmation bias. The presence of well-known mechanisms and logical inference from them may create problems in the evaluation of data. This is called plausibility bias.

Another type of bias is expectation bias. If a result different from the known results has been achieved and it is against the editor’s will, it can be challenged. Bias may be introduced during the publication of studies, such as publishing only positive results, selection of study results in a way to support a view or prevention of their publication. Some editors may only publish research that extols only the positive results or results that they desire.

Bias may be introduced for advertisement or economic reasons. Economic pressure may be applied on the editor, particularly in the cases of studies involving drugs and new medical devices. This is called commercial bias.

In recent years, before beginning a study, it has been recommended to record it on the Web site www.clinicaltrials.gov for the purpose of facilitating systematic interpretation and analysis in scientific research, informing other researchers, preventing bias, provision of writing in a standard format, enhancing contribution of research results to the general literature and enabling early intervention of an institution for support. This Web site is a service of the US National Institutes of Health.

The last stage in the methodology of clinical studies is the selection of intervention to be conducted. Placebo use assumes an important place in interventions. In Latin, placebo means ‘I will be fine’. In medical literature, it refers to substances that are not curative, do not have active ingredients and have various pharmaceutical forms. Although placebos do not have active drug characteristic, they have shown effective analgesic characteristics, particularly in algology applications; further, its use prevents bias in comparative studies. If a placebo has a positive impact on a participant, it is called the placebo effect ; on the contrary, if it has a negative impact, it is called the nocebo effect . Another type of therapy that can be used in clinical research is sham application. Although a researcher does not cure the patient, the researcher may compare those who receive therapy and undergo sham. It has been seen that sham therapies also exhibit a placebo effect. In particular, sham therapies are used in acupuncture applications ( 11 ). While placebo is a substance, sham is a type of clinical application.

Ethically, the patient has to receive appropriate therapy. For this reason, if its use prevents effective treatment, it causes great problem with regard to patient health and legalities.

Before medical research is conducted with human subjects, predictable risks, drawbacks and benefits must be evaluated for individuals or groups participating in the study. Precautions must be taken for reducing the risk to a minimum level. The risks during the study should be followed, evaluated and recorded by the researcher ( 1 ).

After the methodology for a clinical study is determined, dealing with the ‘Ethics Committee’ forms the next stage. The purpose of the ethics committee is to protect the rights, safety and well-being of volunteers taking part in the clinical research, considering the scientific method and concerns of society. The ethics committee examines the studies presented in time, comprehensively and independently, with regard to ethics and science; in line with the Declaration of Helsinki and following national and international standards concerning ‘Good Clinical Practice’. The method to be followed in the formation of the ethics committee should be developed without any kind of prejudice and to examine the applications with regard to ethics and science within the framework of the ethics committee, Regulation on Clinical Trials and Good Clinical Practice ( www.iku.com ). The necessary documents to be presented to the ethics committee are research protocol, volunteer consent form, budget contract, Declaration of Helsinki, curriculum vitae of researchers, similar or explanatory literature samples, supporting institution approval certificate and patient follow-up form.

Only one sister/brother, mother, father, son/daughter and wife/husband can take charge in the same ethics committee. A rector, vice rector, dean, deputy dean, provincial healthcare director and chief physician cannot be members of the ethics committee.

Members of the ethics committee can work as researchers or coordinators in clinical research. However, during research meetings in which members of the ethics committee are researchers or coordinators, they must leave the session and they cannot sign-off on decisions. If the number of members in the ethics committee for a particular research is so high that it is impossible to take a decision, the clinical research is presented to another ethics committee in the same province. If there is no ethics committee in the same province, an ethics committee in the closest settlement is found.

Thereafter, researchers need to inform the participants using an informed consent form. This form should explain the content of clinical study, potential benefits of the study, alternatives and risks (if any). It should be easy, comprehensible, conforming to spelling rules and written in plain language understandable by the participant.

This form assists the participants in taking a decision regarding participation in the study. It should aim to protect the participants. The participant should be included in the study only after it signs the informed consent form; the participant can quit the study whenever required, even when the study has not ended ( 7 ).

Peer-review: Externally peer-reviewed.

Author Contributions: Concept - C.Ö.Ç., A.D.; Design - C.Ö.Ç.; Supervision - A.D.; Resource - C.Ö.Ç., A.D.; Materials - C.Ö.Ç., A.D.; Analysis and/or Interpretation - C.Ö.Ç., A.D.; Literature Search - C.Ö.Ç.; Writing Manuscript - C.Ö.Ç.; Critical Review - A.D.; Other - C.Ö.Ç., A.D.

Conflict of Interest: No conflict of interest was declared by the authors.

Financial Disclosure: The authors declared that this study has received no financial support.

Advance Care Planning

Compassion & Choices is working to help people and providers initiate open, honest conversations, memorialize their wishes in advance directives, and become strong advocates for themselves and their loved ones while at the same time advancing federal policy solutions to improve the enforceability and access to advance directives.

What is Advance Care Planning?

Advance care planning is the process of planning for future medical care in the event that the patient is unable to make their own decisions. Advance Care Planning is not a single decision; it is a process that occurs over a lifetime as goals and values change. During the process, patients: 

• Decide who will speak for them if they can no longer make decisions themselves
• identify and clarify their values, priorities and goals about health and medical treatment. 
• Gain clarity around the types of decisions that might need to be made and identify the care they would like to receive or not receive in various situations. 
• Let others know—both family and health care providers—about care preferences at life’s end.  

Advance care planning is designed to ensure that a patient's wishes will be respected in the event that the patient is unable to participate in decision-making.

Why Does Advance Care Planning Matter?

Advance care planning helps ensure future medical treatment conforms with an individual's beliefs and values, mitigates bias to ensure people get the full breadth of care they want, and protects against excessive, unwanted treatment. Not having documentation of your end-of-life care plans and wishes could mean: 

• Physicians and family members may be left to make uninformed, agonizing, life-and-death decisions  
• Potentially receiving excessive and unwanted care which could reduce quality of life. 
• Prolonging suffering, making those last months, weeks and days difficult for you and your loved ones. 
• Potentially not getting the care that you would want.

What is an Advance Directive?

Advance directive is a general term for any document that contains instructions pertaining to a person’s wishes related to medical treatment if they can not make care decisions on their own. Everyone over 18 should have an advance directive to increase the likelihood you will get the care you want. Common advance directives include:

• a living will (“what I want”)
• a medical durable power of attorney (“who will speak for me”) - this person is sometimes referred to as a health care proxy
• Do not resuscitate and do not intubate orders; simple orders indicating when or if you want this care.
• POLST: Portable Medical Order (described below)

In most states, a lawyer is not required to fill out an advance directive; one simply needs to sign in front of the required witnesses. Advance directives are one important output of advance care planning; however, they are not the only aspect. Understanding and communicating your priorities are just as important.

Use the links below to explore the resources available to you:

How do i get started with advance care planning .

Our  end-of-life decisions guide  is an excellent place to get started. In short, below are the steps involved in advance care planning.

• Think about your wishes for future care if you become seriously ill. Your wishes may be shaped by your experiences, cultural and religious views, your values and your goals.
• Select a healthcare agent – someone that you trust to make medical decisions for you if you can’t make them yourself.
• Discuss your wishes with your healthcare agent and other loved ones. This step is sometimes difficult, but it is very important and may help avoid future conflicts.
• Complete an Advance Care Planning document, like an Advance Directive. In some situations, a health care provider might suggest also completing a Physician Order for Life-Sustaining Treatment (POLST) form.
• Make copies and share copies with your healthcare agent, physicians and loved ones. Make sure that your Advance Directive is in your medical record.
• Periodically reviewing your Advance Care Planning documents to be sure names, contact information and healthcare wishes haven’t changed.

What is a POLST: Portable Medical Order?

POLST has  different names in different states . At the national level, it is currently called POLST: Portable Medical Orders, or POLST for short. A POLST:

• Is a medical order created by your physician through a process of shared-decision making.
• Reflects the types of life-sustaining treatments– such as CPR or tube-feeding– that a patient wants or doesn’t want based on their diagnosis, prognosis, values, beliefs and goals for care.
• Is a part of advance care planning that is designed for patients with serious illness or frailty, for whom a healthcare professional would not be surprised if the patient died within one year.
• Is created by a medical provider; in some states, the patient or designated surrogate signs it.
• A means to translate advance directive decisions into physician orders that all medical personnel follow for people who are within a year of death.

A POLST is not an advance directive and does not substitute for naming a health care agent or durable power of attorney for health care.  

Currently, only about half of all states have POLST forms available. Make sure to check with your physician about whether or not your state uses a version of POLST.

Other common names for POLST are:

• physician orders for life-sustaining treatment
• portable orders for Life-Sustaining Treatment
• provider orders for Life-Sustaining Treatment
• medical orders for Life-Sustaining Treatment

For more information about POLST, see  National POLST .

What is a DNR?

DNR means "Do Not Resuscitate." DNR orders are written instructions telling healthcare providers not to perform Cardiopulmonary Resuscitation (CPR). CPR uses mouth-to-mouth or machine breathing and chest compressions to restore the work of the heart and lungs when someone's heart or breathing has stopped. It is an emergency rescue technique that was developed to save the life of people who are generally in good health

During CPR, you may receive compressions (pushing) on your chest or electrical shock and drugs to restart your heart. In a small number of cases, CPR can save a patient's life and allow them to recover fully and leave the hospital. However, the likelihood of surviving resuscitation for chronically ill elderly patients is very low.

• CPR recovery. After CPR, more likely than not, you will need to be moved to the ICU. You may also have damaged or broken ribs caused by chest compressions. If your heart and breathing are stopped for a while, brain damage may occur.
• CPR survival.  Research  suggests that only 10–20% of all people who get CPR will survive and recover enough to leave the hospital. For chronically ill elderly patients, one  study  has shown a less than 5% chance of surviving long enough to leave the hospital after receiving CPR. The study does not evaluate the quality of life for those who leave the hospital.

Patients who do not want CPR should fill out a DNR order, making sure that it is on the proper color paper. If you do not have a DNR order, healthcare providers will begin CPR in an emergency.

What are Do Not Intubate Orders?

Intubation with ventilation is for people who are severely ill and not able to breathe on their own. It is used when other methods of treatment are no longer working. The procedure is performed in the hospital. You’ll remain in the intensive care unit (ICU) throughout the ventilation process.

For intubation, a tube goes into your mouth or nose, down your throat and into your windpipe. It is connected to a machine called a ventilator. You cannot speak or swallow. You would be in a medically induced coma and given pain-relieving medications before and throughout the process.

Ventilation is a life support treatment. It pushes oxygen into your lungs to help you breathe and into your heart and kidneys so they can work properly. Ventilation helps keep you alive, giving the lungs a longer time to recover on their own. It essentially buys time.

Intubation with ventilation will extend your life and may allow you to recover. However, it is an invasive procedure that has the potential to diminish the quality of life for those who do survive. People least likely to recover are those who are seriously ill from heart, lung, liver or kidney failure, who are over age 65, or who have a terminal illness like cancer or advanced dementia.

If you do not want to be intubated, you should fill out a Do Not Intubate order. Otherwise, you will likely be intubated.

What are the Limitations of Advance Directives?

Below is an excerpt from  Finish Strong  based on a 2016 oped by Kim Callinan outlining the limitations of Advance Directives.

An advance directive may provide peace of mind by explaining to your doctors and family what healthcare you would prefer to receive if you become incapacitated. But unfortunately, they do little to prevent the kind of futile overtreatment most people wish to avoid. There is increasing understanding that people’s advance directives alone are not enough to ensure that people’s end-of-life goals, priorities and values are honored. Some of the reasons advance directives fail include:

• Limited applicability: Standard advance directives take effect only when one of two conditions is established: 1) terminal illness and 2) permanent unconsciousness. Confirming that a person is definitely in one of those two categories may take days or weeks, during which time an unwanted hospitalization and much avoidable suffering may have already occurred. The wording of those documents encourages hopeful thinking about forestalling imminent death and restoring absent brain function.
• Lack of dialogue: Instructions on paper are mostly ineffective unless the people authorized to give them the effect know in advance what the instructions say. The unconscious person and health care proxy often have not discussed the goals, preferences and values outlined in the advance directive. In fact, fewer than three in ten people have actually talked with their loved ones about end-of-life care, according to a survey conducted by the Conversation Project.
• Lack of relevance. Since advance directives are, by definition, written in advance - sometimes many years in advance - they often lack relevance to current events and the circumstances in place at the time the documents are needed.
• Lack of access. It is all too common that an advanced directive along with the DNR order is locked away in a desk or safe when a life-threatening emergency arises, leaving family members and medical providers unsure whether they even exist.
• Lack of enforcement: Doctors are not held accountable for following (or not following) advance directives. In fact, most states grant doctors legal protection for either following the instructions in an advance directive or not following them. Until the documents include enforcement mechanisms, physicians have little incentive to follow them. They are more likely to revert to training, to do everything possible to keep a terminally ill person alive, regardless of whether the treatment only prolongs an agonizing dying process.

Are There Ways to Increase the Likelihood my Advance Directive will be Honored?

The most important ways to increase the likelihood your advance directive will be honored is:

• Select a healthcare proxy who is a strong advocate and will honor your wishes. Have regular and frequent conversations about the care you want and don’t want and share your advance directions, any addendums and the values and priorities worksheet from our End-of-Life Planning guide.
• Share your advance directive with any friend or family member who may be present at the end and make sure they are clear about your priorities; if any family member seems unwilling to honor your wishes, specifically note in your advance directive that you do not want them to speak for you.
• Consider videotaping your advance directive as one additional confirmation of your wishes.
• Set up an appointment with your provider to review your advance directive and confirm they will honor your request; ask them to add it to your medical record.
• Share your advance directive with any hospitals in the area and ask them to include it in your medical record.

In addition to filling out the forms noted above, we’d also recommend you consider the following:

• Dementia Addendum : a Compassion & Choices exclusive online tool that creates a customized addendum to your advance directive to direct your care should dementia take hold.
• Sectarian Healthcare Directive  is an addendum to clarify that your wishes supersede those of any institution’s religious policies and that you wish to be transferred if any facility refuses to follow the preferences you’ve outlined in your advance directive.
• Hospital Visitation Form  gives unmarried couples hospital visitation authorization.
• Assisted Living Facility (ALF) Rider  is a contract rider for people who live in assisted-living facilities and would like to stay there until they die. This will ensure an individual’s home is suited to their choices.

Tools and Resources

• End-of-Life Decisions Guide (English)  and  Spanish . Helping you think through your values and priorities, choose a healthcare proxy and document your care preferences for life’s end.
• Plan Your Care Resource Center . Everything you need to begin planning for the end.
• 1 in 2 older adults now die with a dementia diagnosis , by Kim Callinan

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VICTORY: Colorado Gov. Jared Polis signed the improved End-of-Life Options Act.

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• Knowledge Base

Methodology

Research Methods | Definitions, Types, Examples

Research methods are specific procedures for collecting and analyzing data. Developing your research methods is an integral part of your research design . When planning your methods, there are two key decisions you will make.

First, decide how you will collect data . Your methods depend on what type of data you need to answer your research question :

• Qualitative vs. quantitative : Will your data take the form of words or numbers?
• Primary vs. secondary : Will you collect original data yourself, or will you use data that has already been collected by someone else?
• Descriptive vs. experimental : Will you take measurements of something as it is, or will you perform an experiment?

Second, decide how you will analyze the data .

• For quantitative data, you can use statistical analysis methods to test relationships between variables.
• For qualitative data, you can use methods such as thematic analysis to interpret patterns and meanings in the data.

Table of contents

Methods for collecting data, examples of data collection methods, methods for analyzing data, examples of data analysis methods, other interesting articles, frequently asked questions about research methods.

Data is the information that you collect for the purposes of answering your research question . The type of data you need depends on the aims of your research.

Qualitative vs. quantitative data

Your choice of qualitative or quantitative data collection depends on the type of knowledge you want to develop.

For questions about ideas, experiences and meanings, or to study something that can’t be described numerically, collect qualitative data .

If you want to develop a more mechanistic understanding of a topic, or your research involves hypothesis testing , collect quantitative data .

You can also take a mixed methods approach , where you use both qualitative and quantitative research methods.

Primary vs. secondary research

Primary research is any original data that you collect yourself for the purposes of answering your research question (e.g. through surveys , observations and experiments ). Secondary research is data that has already been collected by other researchers (e.g. in a government census or previous scientific studies).

If you are exploring a novel research question, you’ll probably need to collect primary data . But if you want to synthesize existing knowledge, analyze historical trends, or identify patterns on a large scale, secondary data might be a better choice.

Descriptive vs. experimental data

In descriptive research , you collect data about your study subject without intervening. The validity of your research will depend on your sampling method .

In experimental research , you systematically intervene in a process and measure the outcome. The validity of your research will depend on your experimental design .

To conduct an experiment, you need to be able to vary your independent variable , precisely measure your dependent variable, and control for confounding variables . If it’s practically and ethically possible, this method is the best choice for answering questions about cause and effect.

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Your data analysis methods will depend on the type of data you collect and how you prepare it for analysis.

Data can often be analyzed both quantitatively and qualitatively. For example, survey responses could be analyzed qualitatively by studying the meanings of responses or quantitatively by studying the frequencies of responses.

Qualitative analysis methods

Qualitative analysis is used to understand words, ideas, and experiences. You can use it to interpret data that was collected:

• From open-ended surveys and interviews , literature reviews , case studies , ethnographies , and other sources that use text rather than numbers.
• Using non-probability sampling methods .

Qualitative analysis tends to be quite flexible and relies on the researcher’s judgement, so you have to reflect carefully on your choices and assumptions and be careful to avoid research bias .

Quantitative analysis methods

Quantitative analysis uses numbers and statistics to understand frequencies, averages and correlations (in descriptive studies) or cause-and-effect relationships (in experiments).

You can use quantitative analysis to interpret data that was collected either:

• During an experiment .
• Using probability sampling methods .

Because the data is collected and analyzed in a statistically valid way, the results of quantitative analysis can be easily standardized and shared among researchers.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

• Chi square test of independence
• Statistical power
• Descriptive statistics
• Degrees of freedom
• Pearson correlation
• Null hypothesis
• Double-blind study
• Case-control study
• Research ethics
• Data collection
• Hypothesis testing
• Structured interviews

Research bias

• Hawthorne effect
• Unconscious bias
• Recall bias
• Halo effect
• Self-serving bias
• Information bias

Quantitative research deals with numbers and statistics, while qualitative research deals with words and meanings.

Quantitative methods allow you to systematically measure variables and test hypotheses . Qualitative methods allow you to explore concepts and experiences in more detail.

In mixed methods research , you use both qualitative and quantitative data collection and analysis methods to answer your research question .

A sample is a subset of individuals from a larger population . Sampling means selecting the group that you will actually collect data from in your research. For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

In statistics, sampling allows you to test a hypothesis about the characteristics of a population.

The research methods you use depend on the type of data you need to answer your research question .

• If you want to measure something or test a hypothesis , use quantitative methods . If you want to explore ideas, thoughts and meanings, use qualitative methods .
• If you want to analyze a large amount of readily-available data, use secondary data. If you want data specific to your purposes with control over how it is generated, collect primary data.
• If you want to establish cause-and-effect relationships between variables , use experimental methods. If you want to understand the characteristics of a research subject, use descriptive methods.

Methodology refers to the overarching strategy and rationale of your research project . It involves studying the methods used in your field and the theories or principles behind them, in order to develop an approach that matches your objectives.

Methods are the specific tools and procedures you use to collect and analyze data (for example, experiments, surveys , and statistical tests ).

In shorter scientific papers, where the aim is to report the findings of a specific study, you might simply describe what you did in a methods section .

In a longer or more complex research project, such as a thesis or dissertation , you will probably include a methodology section , where you explain your approach to answering the research questions and cite relevant sources to support your choice of methods.

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The Case for Advance Care Planning

• Case for Advance Care Planning - Fact Sheet

The problem: Too few Americans have planned the care that they wish to receive near the end of their lives, despite the many proven benefits that such planning provides for patients and their families. As a result, many people receive care that does not align with their preferences and values.

The solution: Increase the use of advance care planning, which will give more patients the opportunity to understand their options, communicate their preferences, and ensure that their wishes are recorded and honored by health providers and family members.

What Is Advance Care Planning?

Advance care planning is the “discussion of end-of-life care, clarification of related values and goals, and embodiment of preferences through written documents and medical orders.” 1  These discussions occur among patients, their doctors, and their families and are updated as needed. Advance care planning conversations can help people understand their diagnoses, the health care choices they are likely to face, and the potential risks and benefits of different treatment options.

Why is advance care planning important?

Numerous studies demonstrate that even the sickest people rarely discuss their preferences for end-of-life care—the medical treatment received in the final months and weeks of life—with loved ones or their medical care teams. For example, a recent study of patients with advanced cancer found that only 27 percent had discussed end-of-life issues with their oncologists, and most had never discussed pain management with any doctor. 2 A 2012 survey by the California HealthCare Foundation found that more than three-quarters of respondents wanted to talk to their doctors about their end-of-life care wishes, yet 90 percent said a doctor had never asked them about those issues. 3

Unfortunately, health care agents, or surrogates, often have to make decisions on behalf of seriously ill loved ones. When advance care planning conversations have not occurred, caregivers are forced to guess what patients would want. 4 Research has found that people often receive aggressive treatments in the intensive care unit and ultimately die in the hospital when they would have preferred to die in their homes. Furthermore, family members struggle to make decisions for dying patients and experience stress, guilt, and regret when they aren’t confident that they know their loved one’s wishes. 5

It’s always too early, until it’s too late.  The Conversation Project, 2013

Benefits of advance care planning

Rigorous research has demonstrated that people who participate in advance care planning reap many benefits. They are more likely to have their end-of-life wishes known and respected. 6 Patients and their families are more satisfied with the care received after they have these conversations with doctors. 7  Furthermore, people are less likely to receive unwanted aggressive medical treatments in their last weeks of life, 8 less likely to die in the hospital or intensive care unit, 9  and more likely to enroll in hospice, 10 the comprehensive care that supports patients and their families in the final phase of terminal illness with a focus on comfort and quality of life.

Some people worry that talking about death can cause patients and families to lose hope and even become sicker. However, research shows that advance care planning does not lead to depression, anxiety, or emotional suffering 11 and has no impact on patient survival. 12 Although these conversations can be very emotional, families and patients generally find them helpful and appreciate the opportunity to prepare for the future.

How Advance Care Planning Helps Families

Family members of dying patients also benefit from advance care planning. Relatives of those who participate have a better understanding of the patient’s wishes, and therefore greater confidence and less stress in making end-of-life treatment decisions for their loved one. 13  Families that have frank conversations in preparation for death experience less burden as caregivers 14 and go through less post-traumatic stress, depression, anxiety, and emotional trauma after the patient’s passing. 15  A 2013 survey revealed that more than 9 in 10 Americans think it is important to talk about their wishes for end-of-life care, yet only 3 in 10 have held these discussions. 16

Increasing the use of advance care planning

Given the importance of advance care planning, we all must work together to eliminate barriers to its effective use. One historical barrier has been that providers have not been paid for these conversations with patients. 17 In July 2015, however, Medicare addressed this challenge by proposing to pay providers for time spent engaging with patients on advance care planning.

Other challenges remain, however. For example, it can be difficult to access advance care planning documents across different care settings. We also lack good ways to measure the quality of care received at the end of life, and whether that care was consistent with a patient’s preferences. The Care Planning Act, sponsored by Senators Johnny Isakson (R-GA) and Mark Warner (D-VA) , would address these and other issues. The passage of this and similar legislation can ensure that some of the most vulnerable patients are able to express their preferences and have their wishes honored at the end of their lives.

• Institute of Medicine, Dying in America: Improving Quality and Honoring Individual Preferences Near the End of Life , (Washington, DC: National Academies Press, 2014), 3–4.
• Jennifer W. Mack et al., “End-of-Life Discussions Among Patients with Advanced Cancer: A Cohort Study,” Annals of Internal Medicine 153, no. 3 (2012): 4–5, doi: 10.7326/0003-4819-156-3-201202070-00008.
• California HealthCare Foundation, “Final Chapter: Californians’ Attitudes and Experiences With Death and Dying” (2012), http://www.chcf.org/publications/2012/02/final-chapter-death-dying .
• Maria J. Silveira, Scott Y. H. Kim, and Kenneth M. Langa, “Advance Directives and Outcomes of Surrogate Decision Making Before Death,” New England Journal of Medicine 362, no. 13 (2010): 12141216, doi: 10.1056/NEJMsa0907901.
• David Wendler and Annette Rid, “Systematic Review: The Effect on Surrogates of Making Treatment Decisions for Others,” Annals of Internal Medicine 154, no. 5 (2011): 344, doi: 10.7326/0003-4819-154-5-201103010-00008.
• Karen M. Detering et al., “The Impact of Advance Care Planning on End-of-Life Care in Elderly Patients: Randomized Controlled Trial,” BMJ 340 (2010): 4–5, doi: 10.1136/bmj.c1345.
• Joan M. Teno et al., “Association Between Advance Directives and Quality of End-of-Life Care: A National Study,” Journal of the American Geriatrics Society 55, no. 2 (2007): 192, doi: 10.1111/j.1532-5415.2007.01045.x.
• Rhea A. Stein et al., “Randomized Controlled Trial of a Structured Intervention to Facilitate End-of-Life Decision Making in Patients With Advanced Cancer,” Journal of Clinical Oncology 31, no. 27 (2013): 3406, doi: 10.1200/JCO.2011.40.8872; Detering et al., “The Impact of Advance Care Planning,” 4–5. 
• Lauren H. Nicholas et al., “Regional Variation in the Association Between Advance Directives and End-of-Life Medicare Expenditures,” Journal of the American Medical Association 306, no. 13 (2011): 1451, doi: 10.1001/jama.2011.1410.
• Stein et al., “Randomized Controlled Trial of a Structured Intervention,” 3406.
• Detering et al., “The Impact of Advance Care Planning,” 4–5.
• Wendler and Rid, “Systematic Review: The Effect on Surrogates,” 344.
• The Conversation Project, “New Survey Reveals 'Conversation Disconnect': 90 Percent Of Americans Know They Should Have a Conversation About What They Want at the End of Life, Yet Only 30 Percent Have Done So” (2013), http://theconversationproject.org/wp-content/uploads/2013/09/TCP-Survey-Release_FINAL-9-18-13.pdf .
• Institute of Medicine, “Dying in America,” 3-1.

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• To the Health Care Provider site

Advance Care Planning

Advance care planning (ACP) is a process of preparing a person and/or their substitute decision-maker (SDM) to make healthcare decisions in the future if necessary. ACP conversations include discussions about:

• Identifies the future Substitute Decision-Maker by confirming that he or she is satisfied with his or her default/automatic SDM in the hierarchy list that is in section 21 of the Health Care Consent Act OR by preparing a POA Personal Care to choose someone else to act as their SDM.  [1] 
• Learning about any illness the person may have and considering how they may progress over time.
• While capable, talks with his or her future substitute decision maker about his or her “wishes”, values and beliefs about future care to prepare the SDM to make health decisions for the person when the person becomes incapable of making their own decisions.  [2]  If the person is not capable, they may still express incapable wishes and values that may be of help to the SDM in the future.

What does this mean?

The automatic SDMs and the hierarchy list of SDMs are explained in more detail in another Q and A. The terms “wishes, values and beliefs” are explained in another Q and A.

The important thing to understand is that:

ACP wishes about future care are NOT decisions (informed consent) to care.   Decisions about specific care and treatment (consents) may only be made when a person understands their illness and knows the possible treatment options. Informed consent is required before treatment is provided.  [3] 

When the person communicates ACP wishes, he or she is speculating about their future health and what care he or she may want or not want. The person may have some information about their health if they have a progressive illness but even then it’s impossible to have a full picture of how their illness will progress or what their future treatment options will be. ACP is still important as it helps prepare both the person and their future SDM for health decision making.

ACP wishes are not “advance consent”. ACP discussions between a person and their future SDM prepare SDMs for when the person is incapable and the SDM must step in to make the informed consent decisions for the incapable person.

ACP wishes are NOT directions to health practitioners. ACP wishes and information on the person’s values and beliefs guide the person’s future SDM when the SDM must step in to provide health decisions for that person when incapable. Until the person becomes incapable, the health practitioners must discuss any health decisions with the person even if they have engaged in advance care planning. When the person becomes incapable, the health practitioners must discuss any health decisions with the person’s SDM even if the person previously has engaged in advance care planning.  [4] 

Even though the health practitioner cannot take direction from the ACP wishes, if the health practitioner is aware of the patient’s previous wishes about health care, this may help start the discussion between the health practitioner and the person making the treatment decisions whether that is the patient or the incapable patient’s SDM.

ACP wishes are NOT “goals of care”. Goals of care discussions help the health practitioner understand how the person perceives their illness as well as what they consider is quality of life. GOC are not specific treatments but from this discussion of goals, a plan of treatment may be developed. After discussing goals of treatment, the health practitioner still needs to get informed consent to a plan of treatment before providing that care.  [5] 

More information on Goals of care is in another Q and A.

Only people, when mentally capable for health care decisions, can engage in ACP. SDMs cannot ACP for an incapable person. SDMs can only give or refuse consent to treatment  [6]  or other health care on behalf of an incapable person.

• [1] Health Care Consent Act, s.21
• [2] Health Care Consent Act, s.5
• [3] Health Care Consent Act, s.10(1)
• [4] Health Care Consent Act, s.10(1)
• [5] Health Care Consent Act, s.10(1)
• [6] Health Care Consent Act, s.10(1)

The term “advance care planning” does not appear in the Ontario law. However the Health Care Consent Act (HCCA) and the Substitute Decisions Act (SDA) do support what has become known as “advance care planning”.  It is important to look at how ACP works under Ontario law because the law related to this issue is provincial specific and there are variations in it across Canada.

The Health Care Consent Act and Substitute Decisions Act include sections:

• On who has to give informed consent – patient or SDM (HCCA s.10),
• On the requirement for informed consent to come from a person (person or SDM) and not an “advance care plan” before treatment is delivered (HCCA s.10)
• on who is an SDM  ( CCA SDM Hierarchy s.21)
• on how to choose a particular person to be one’s SDM ( POA Personal care SDA s. 46) ,
• on how SDMs make decisions for the incapable person ( wishes – best interests (HCCA s. 21)
• on how wishes may be communicated by the person, when capable, to their SDM ( oral, in writing , by alternative means HCCA s. 5)
• on how last known wishes however expressed are the wishes to be honoured

 (HCCA s. 5)

All of these sections are relevant to understanding what is advance care planning in Ontario.

Only a person, when mentally capable for health care decisions, and age 16 or older, may do advance care planning for themselves. [7]  A SDM cannot advance care plan for a person that is incapable. Forms used in health facilities that are called “advance directives by an SDM for an incapable person “  or advance care planning documents signed by an SDM for another person are not valid. SDMs may only give or refuse informed consent on behalf of an incapable person. [8]  

The fact that only people when capable may do advance care planning makes sense in that ACP involves confirming or choosing a future SDM and communicating wishes about future care and information about a person’s own values and beliefs to a future SDM . Only the person can do this for themselves as these are personal tasks and cannot be assigned to anyone else to do.  

• [7] Health Care Consent Act, s.5
• [8] Health Care Consent Act, s.10(1)

An SDM cannot make advance care planning wishes for a person that is incapable to make their own health decisions [9] . An SDM cannot prepare and sign a Power of attorney for Personal care on behalf of a person that is incapable of preparing a POA Personal Care for themselves. [10]

SDMs may only give or refuse consent to treatment or other health care decisions on behalf of the person that is incapable for these decisions. [11]

Some of the misunderstandings about the role of SDMs related to advance care planning may be as a result of forms and policies in some health facilities, as well as from information on the internet and in other materials that make it appear that SDMs may do advance care planning for a person incapable for health care decision making.

Health facilities and organizations that have such forms and policies should review and make changes to these forms and policies to bring them into compliance with the Ontario law on health care consent and substitute decision making.   Such a review would help support health practitioners, allied health staff, as well as patients and their SDMs to engage in better patient centred care practices.

• [9] Health Care Consent Act, s.5
• [10] Substitute Decisions Act, s.46
• [11] Health Care Consent Act, s.10(1)

Any advance care planning wishes, however expressed, in writing, orally or communicated by alternative means, are primarily directions to the patient’s future SDM.  [12]  Only in an emergency when it is not possible to get an informed consent, may a health practitioner use the wishes expressed by a patient to refuse treatment to decide on what emergency treatment should be provided to that patient.

The wishes are not directions to the health practitioners and health team taking care of the patient .The wishes are not health decisions that direct care. Wishes are not informed consents.

Wishes also should not be used by health practitioners to limit treatments options offered to the patient.

Since expressing the wishes, the patient may have changed his or her mind about what health care he or she might want. After the patient understands their current health condition, they may have different goals of care and may want different treatment options.

The health practitioners may use the previous wishes to start a conversation with the patient, but the health practitioner should not limit that conversation and should not restrict discussions to treatment options that the health practitioner thinks the patient would prefer based on their previous wishes.

• [12] Health Care Consent Act, s.5

Advance care planning wishes may be communicated in writing, orally, or in any way that the person uses to communicates , such as via a computer, picture board or other assistive device. [13]  

The only part of advance care planning that must be done in writing is the choice of an SDM if the person does not want their automatic SDM to make decisions for them when they are incapable for health decisions. [14]  That must be done through the preparation of a Power of Attorney for Personal Care,

Information about the automatic SDMs and the SDM hierarchy and about how to prepare a Power of Attorney for Personal Care to choose another SDM are in other Q and As.

If a person wants to communicate their ACP wishes in a written format, they may do that in a Power of Attorney for Personal Care although any written format – a formal “form:” or just a piece of paper or computer file may be used.  [15]

Written ACP wishes do not take precedent over oral wishes or wishes communicated by other means.  It is the duty of SDMs to honour the last known capable wishes of a person however communicated, even if the last known capable wishes are oral and the previous wishes are in a written format.  [16]

• [13] Health Care Consent Act .5(2)
• [14] Substitute Decisions Act, s.46
• [15] Health Care Consent Act, s.5(2)
• [16] Health Care Consent Act, s 5(3)

No. Advance care planning wishes may be communicated in writing, orally, or in any way that the person uses to communicates, such as via a computer, picture board or other assistive device. Oral wishes or wishes communicated by other means are as valid as written wishes. [17]

In fact, later oral wishes or wishes communicated by other means will override earlier written wishes.  

The only part of advance care planning that must be done in writing is the choice of an SDM if the person does not want their automatic SDM to make decisions for them when they are incapable for health decisions. That must be done through the preparation of a Power of Attorney for Personal Care. [18]  

• [17] Health Care Consent Act, s.5(2)
• [18] Substitute Decisions Act, s.46

It is not necessarily better to put ACP wishes in writing because ACP wishes may also be communicated orally or by other means. In fact later oral wishes or wishes communicated by other means will override earlier written wishes [19] .  

Whether to put ACP wishes in writing is a personal choice.

Some people want to put their wishes in writing because they think that will be most helpful to their SDM. They think the SDM may have a better understanding of what they meant by their wish if they write it down. If it is in writing, the SDM can refer back to it when making decisions for the person when incapable.

If the person anticipates that other family and friends, who are not the SDM, may challenge the SDM over decisions that the SDM will need to make for the person when incapable, putting the wishes in writing may help the SDM to justify these decisions.  The written format would be direct evidence that the person when capable did express the wishes.

If a person decides to put their ACP wishes in writing, he or she must remember that if they change their wishes, they should also change the written form. Although later oral wishes will override the earlier written wishes, to avoid confusion, the written wishes should also be changed.

Also, if a person puts the wishes in writing, he or she should still discuss these wishes with their future SDM to make certain that the SDM understands what the wishes mean. The person making the wishes may think the wish is obvious and easy to understand but in fact the SDM may have a different interpretation of the written wish.

However a person expresses ACP wishes, he or she should make sure that they and their future SDM have a common understanding of the wishes.

• [19] Health Care Consent Act, s.5

THERE IS NO REFERENCE IN THE HEALTH CARE CONSENT ACT OR SUBSTITUTE DECISIONS ACT TO “ADVANCE DIRECTIVES” OR “LIVING WILLS”. “ADVANCE DIRECTIVES” AND “LIVING WILLS” ARE THE NAMES OF DOCUMENTS DESCRIBED IN THE LAW IN OTHER JURISDICTIONS (I.E., OTHER PROVINCES, US STATES). THESE TERMS ARE USED IN COMMON LANGUAGE IN ONTARIO TO DESCRIBE ANY DOCUMENTS IN WHICH A PERSON WRITES DOWN THEIR WISHES FOR FUTURE HEALTH CARE,

The health care consent act does include a section about wishes. it states that a a  person may, while capable, express wishes with respect to treatment, admission to a care facility or a personal assistance service. [20]    wishes may be expressed in writing in a power of attorney for personal care or in any other written form, or may be expressed orally or communicated by any means that the person uses to communicate such as through assistive devices. [21]  later wishes expressed while capable prevail over earlier wishes. [22]  , the substitute decisions act does refer to powers of attorney for personal care [23]  which are documents that a person may use to appoint someone, known as their attorney, to make personal care decisions for them if that person becomes incapable for personal care decisions. personal care decisions include decisions about health care, shelter, nutrition, hygiene, clothing and safety.  [24].

THE TERMS “ADVANCE DIRECTIVE” AND “LIVING WILL” SHOULD NOT BE USED IN ONTARIO BECAUSE THERE IS NO REFERENCE IN THE LAW TO SUCH DOCUMENTS AND THE USE OF THESE TERMS CAUSES CONFUSION.

THERE ARE DOCUMENTS, KNOWN AS DIRECTIVES, USED IN THE HEALTH SYSTEM THAT ARE AUTHORITATIVE AND THAT GIVE DIRECTIONS TO HEALTH PRACTITIONERS WHEN PROVIDING CERTAIN TYPES OF CARE.  IN CONTRAST ADVANCE CARE PLANNING WISHES AND INFORMATION IN THESE “ADVANCE DIRECTIVES” AND LIVING WILLS” ARE NOT DIRECTIONS TO A HEALTH PRACTITIONER BUT ARE COMMUNICATIONS TO THE PATIENT’S FUTURE SDM TO BE USED BY THAT SDM WHEN GIVING OR REFUSING CONSENT ON BEHALF OF THE INCAPABLE PATIENT.

By using the terminology in the Health Care Consent Act it should increase understanding about ACP as it is done in Ontario and reduce confusion about who takes direction from ACP wishes.

• [20] Health Care Consent Act ,s. 5(1)
• [21] Health Care Consent Act, s. 5(2)
• [22] Health Care Consent Act, s. 5(3)
• [23] Substitute Decisions Act, s.46
• [24] Substitute Decisions Act, s.45

When a person is advance care planning, that person has an opportunity to communicate their “wishes” about future care to prepare their SDM for the SDM’s future role as decision maker for the person. What are ACP “wishes”?

Wishes are NOT decisions and are not informed consents.  Wishes are not directions to the health practitioners or to others providing care to a person.  Only in an emergency, when it’s not possible to get an informed consent to treatment, if the health practitioner knows of any wishes expressed by the person when capable to refuse a treatment, the health practitioner may honour that wish when deciding on what emergency care to give to that person. [25]  Otherwise, the health practitioner must get an informed consent from a person or an incapable person SDM despite knowledge of a “wish” about care.  [26]

The word “wishes” in the Health Care Consent Act refers to wishes about treatment, admission to long term care, and personal assistance services (HCCA S. 5). Treatment, admission to long term care and personal assistance services are all types of health care. These terms are explained in another Q and A.

Wishes do not need to be about specific treatments or care options although a person could do that.  A person could express a wish that they would never want to have a specific type of treatment (tube feeding, CPR, certain medications etc.) or a specific type of care (a wish never to live in a long term care home, a wish to be able to die at home).

Wishes also may also be statements about what the person thinks of as quality of life and what makes life worth living. Wishes may include communications to the future SDM about what the person thinks is important (prolonging life even if living with some limitations; being able to communicate with family; having food and drink even if artificial nutrition would prolong life). The person may communicate how they do a risk-benefit analysis when making health decisions and ask that the SDM try to do the same type of analysis when the SDM steps into the decision making role.

Wishes may also be expressed to the SDM to consider the person’s values and beliefs held by that person when capable, when considering care options and treatments.  The values and beliefs may be from a particular faith or religion or may be opinions of that person about the value of life and how life should be lived. Values and beliefs usually affect how a person sets priorities in their life are the measures that the person uses to determine if their life is being lived in the way they want to live it.

When expressing wishes about future care, the person must understand that he or she cannot fully anticipate what their health might be in the future or how they will experience a particular health problem. Also treatment options change as science advances so what would be a treatment that the person is convinced that they would not want might be a treatment that the person would have consented to if still capable and had all the information to make an informed decision.

If a person has a progressive disorder, they may have a better understanding of the trajectory of their illness but even then it’s not possible to predict everything that might happen.

When making wishes about future health care as part of advance care planning, the person needs to understand the principles that their SDM must follow when making substitute decisions. Understanding these principles of honouring the persons wishes expressed when capable and acting in the incapable person’s “best interests” when wishes are not known or are impossible to honour will help a person do better advance care planning and better prepare their SDM for this future decision making role. How an SDM is required to make decisions for an incapable person is explained in another Q and A.

ACP wishes are NOT “goals of care”. Goals of care discussions help the health practitioner understand how the person perceives their illness as well as what they consider is quality of life. GOC are not specific treatments but from this discussion of goals, a plan of treatment may be developed. The health practitioner then needs to get informed consent to that plan of treatment before providing that care. More information on Goals of care is in another Q and A.

Only capable persons can engage in ACP. SDMs cannot ACP for an incapable person. SDMs can only give or refuse consent to treatment or other health care on behalf of an incapable person.

• [25] Health Care Consent Act, s26.
• [26] Health Care Consent Act, s. 10(1)

The SDM is required to honour the person’s capable wishes when making health decisions for that person when he or she is incapable. How the SDM honours a person’s capable wishes is explained in another Q and A.

There are two exceptions to this rule about following the wishes:

a. If the wish is impossible to honour (HCCA s.21(2)) then the SDM does not need to try to follow it but instead must determine what is in the “best interests” of the incapable person and make decisions using that best interest standard.  “Best interests” is explained in another Q and A.  

b. if the wish directed the SDM to refuse consent to a treatment or any other type of health care, the substitute decision-maker or the person’s health practitioner may apply to the Consent and Capacity Board for permission to consent to the treatment despite the wish. [27]  The Consent and Capacity Board may give permission for the SDM to consent to the treatment despite the wish if it is satisfied that the incapable person, if capable, would probably give consent because the likely result of the treatment is significantly better than would have been anticipated at the time the wish was expressed. This application to the Consent and Capacity Board is explained in another Q and A.

• [27] Health Care Consent Act,  s.36

The SDM is required to make decisions for an incapable person by following or “honouring” the wishes about health care, [28]  made by the person when capable, but that may be a challenging task. It’s unlikely the person when capable had communicated wishes about every possible health decision that might need to be made after that person became incapable.

Some wishes also may be broad in scope and not specific, such as wishes for “no heroic measures” if the person is at end of life.  General wishes, although not specific to a treatment or type of care, such as wishes that express what the person thinks of as quality of life may help the SDM to determine what to do when making a specific decision.

The SDM has to apply the wishes when making decisions but also has to interpret what the person meant by the wish.  What a wish means may not be that obvious except to a person, like the SDM, that knew the person when he or she was capable.

Before applying the wishes and making a decision for the incapable person, the SDM must determine:

• whether the wishes of the person were expressed when the person was capable (and were expressed voluntarily);
• whether the wishes are the last known capable wishes of the person;
• what the person meant by the wish;
• If there are no applicable capable wishes, how the patient’s values, beliefs, and incapable/inapplicable wishes would apply to the patient’s best interests
• [28] Health Care Consent Act, s. 21(1)

Forms for advance care planning, goals of care and health care consent developed in other provinces or in national or international research projects should NOT be used in Ontario UNLESS the forms have been checked as to whether they reflect Ontario law related to ACP, GOC and health care consent and modified appropriately if necessary.

A research paper commissioned by the Law Commission of Ontario on forms, policies and practices used in Ontario health facilities for advance care planning , goals of care,  and health care consent [29]  found that many health facilities and organizations were using forms, policies, and practice systems from other jurisdictions without adaptation  to comply with Ontario law.  This results in practices that are not patient centred, and that do not respect patients/SDM’s rights in health decision making. This also could expose health practitioners to claims for damages and claims of professional misconduct for failure to get informed consent before providing treatment.

There may be great value in the forms and systems developed in other jurisdictions and in research studies despite the fact that these do not reflect Ontario law.  That work needs to be put into the context of the Ontario legal framework and could be ADAPTED to fit into that framework although NOT DIRECTLY ADOPTED or implemented in Ontario without the necessary changes.

• [29] Health Care Consent, Advance Care Planning, and Goals Of Care Practice Tools: The Challenge To Get It Right, December 2016 , Judith A. Wahl,  Mary Jane Dykeman, Tara Walton    https://www.lco-cdo.org/wp-content/uploads/2010/10/ACE%20DDO%20Walton%20Formatted%20Dec%202%2C2016%20LCO.pdf

Health facilities cannot require patients to use particular forms to write down their wishes about future care.  

Doing advance care planning is voluntary. No one needs to express their wishes about future care to anyone although it would be helpful to do this, particularly in order to prepare a person’s SDM for their future decision making responsibilities. Health facilities and health practitioners need to get informed consent before treatment and this can be done even if a person has not engaged in any advance care planning.

No health facility or health service may require a person to prepare a POA Personal Care to appoint someone as their attorney (SDM). The Health Care Consent Act includes an SDM Hierarchy that ensures that everyone in Ontario has an automatic SDM even if they have never prepared a POA Personal Care.

ACP wishes do not need to be written down to be valid. Patients may express ACP wishes, in writing, orally, or communicate these by whatever means that persons use to communicate such as through an assistive device. [30]  Health facilities cannot require a person to put their wishes in writing.

Although health facilities cannot require patients to use particular ACP forms or to write down their wishes about future care, health facilities may create forms about advance care planning that may be used to promote advance care planning and inform patients about the requirement for informed consent and how ACP relates to health care consent.  The form completion by the patient would remain optional.

The forms may support good practice.   Forms may help patients understand who would be their future SDM, how SDMs make decisions for them and about the value of the patient talking with their future SDM about their wishes for future care. .Patients may voluntarily agree to use a facility form to write down their wishes or may provide their wishes about future care to staff in other forms or formats.

If health facilities are using any forms to help engage patients in ACP, they need to check that the forms reflect Ontario law, include the right SDM hierarchy list from the Health Care Consent Act, are clear that the wishes even if written down are not consents, and are clear that staff do not take direction for care of the patient from the recorded wishes.

• [30] Health Care Consent Act, s.5

Health practitioners are encouraged to tell their patient’s about advance care planning as well as to engage in such discussions with patients and the patient’s future SDMs.  However many busy health practitioners question whether they have the time and resources to do this effectively.

There is medical and health literature that detail the benefits to the health system, to patients and their families, and to health practices if patients engage in advance care planning.  By doing advance care planning, there may be savings in time and money and a reduction of conflicts and family disputes about decision-making for an incapable patient.

What does the law state about who should do specific tasks related to ACP and consent?

The law does require the health practitioner offering treatment:

• to get the informed consent before treatment, [31]
• to determine whether the patient is capable to provide that consent  [32]
• to determine who is the incapable patient’s SDM,  [33]
• to explain to the SDM their duty to make decisions for the patient by honouring the patient’s previous capable wishes or acting in the nest interests of the patient.  [34]

More details on what is involved in getting informed consent and what must be communicated by the health practitioner to the patient or SDM is explained in other Q and As. Also other Q and As detail whether any of these obligations may be delegated to another health practitioner or person although the health practitioner is responsible.

In respect to tasks related to advance care planning discussions, the law does not specifically place an obligation on any particular person to explain to a patient that they can express wishes about future care and to inform them that that their SDMs would make decisions for them when incapable although this would be of great benefit to a patient to know.

The law also doesn’t place a specific obligation on anyone to explain to the patient that the SDM is required to follow their capable wishes when making decisions for them and that if wishes are not know that the SDM then must make decisions in their best interests.  This is in contrast to the legal requirement placed on health practitioner to explain to SDMs these principles of substitute decision making (wishes-best interests).

The law also doesn’t specify how some tasks need to be done. Do certain tasks need to be done through discussions whereas some information may be conveyed through written materials, posters, audio and video clips?

Could certain tasks, such as the asking the patient who would be a patient’s future SDM be incorporated into administrative procedures?  

Assuming there is a benefit to the health practitioner, the patients and the SDMs, and to the health system to have everyone be more knowledgeable about advance care planning and health care consent, health practitioners and persons responsible for health systems management should think about the various elements of both health care consent and advance care planning and determine which tasks should be done by which people in a health practice, health facility or health service.  

Who should do what tasks and the best way of doing those tasks related to health care consent and advance care planning is too complex to answer in a simple Q and A.  

This question should alert health practitioners and health systems managers that attention should be paid to thinking through how information on advance care planning and health care consent should be communicated in the health system and in health services.  

This is a more complex issue than it may appear on the surface and good advance care planning and good consent practices involve a variety of health practitioners, allied health and others.  It is critical to understand how advance care planning is related to the requirement for informed consent before designing programmes on advance care planning. Any programmes on advance care planning or health care consent need to be reviewed to ensure that these are compliant with Ontario law before being used.

The relationship between ACP and health care consent is explained in another Q and A.

• [31] Health Care Consent Act, s.10(1)
• [32] Health Care Consent Act, s.10(1)
• [33] Health Care Consent Act, s.10(1)
• [34] M. (A.) v. Benes, 1999 CanLII 3807 (ON CA).

Level of care (LOC)  forms are forms that have been used primarily in long term care homes, and some hospitals, to record general statements about what a resident would want in the event of a sudden change in their present condition. By having these forms in a resident’s chart it is assumed that health staff use these forms to determine what care to provide to the residents.

The LOC forms include tick boxes that list care options in four or five levels, from full care with resuscitation (full code) to lesser degrees of intervention, the lowest level being “comfort care only”. The levels often also often include statements about whether or not a resident would want transfer to hospital or care only at the long term care home and no transfer to hospital.

These forms are not consents to treatments as they are not specific to any treatments and not specific to the individual patient and their particular health condition. Level of care forms are usually not discussed in detail with patients before completion and are too often completed by the patient or the patient's SDM (whether or not the patient is incapable of treatment decision-making) without a prior explanation of the patient's present health condition or the way the completed form will be used by the health team members. LOC forms leave it up to the health practitioners to decide what specific care and treatments that the patient should receive based on a generalized direction.

These forms do not assist health practitioners in fulfilling their duty to get an informed consent to specific treatments from the right person, the resident or the incapable residents SDM. The forms may mislead the health practitioners in thinking that consent has been obtained to no CPR or to other treatments.

Although often referred to as “advance care planning documents” by many long term care homes, there is a serious question about whether the execution of these forms is a valid expression of a resident’s “wishes” for use by health practitioners in an emergency. The value for that purpose would depend on whether the resident was given information on how the LOC form would be used.

The forms as usually drafted give little guidance to the resident’s SDM when the SDM is called upon to make decisions for the resident when incapable because the forms are so broadly worded.  Completion of these forms may not be discussed with the resident and SDM together so they may have different understandings of what the form content means.

Often the form is presented as “required” by the long term care home although any advance care planning should be voluntary. In some cases residents that want to have their wishes recorded in their chart using different forms that they found more meaningful to themselves and their SDM, are told that only the facility form may be used.

These forms have also been misused to not transfer a resident to a hospital for treatment just because the form section on no transfer was ticked off.

It is not possible to give a blanket direction about transfer to hospital in advance of a health incident.

Although a resident may express that if at end of life they would not want to be transferred to hospital and would prefer that the long term care home be their place of death, they might want transfer to hospital to receive treatments for injuries or illnesses that may not be able to be treated at the long term care home, with return to the long term care home post treatment.

The decision of transfer or not to hospital must be specific to the needs of the patient at the time that transfer is considered and cannot be a blanket direction

The wishes on level of care forms should not be driving the care provided to residents. Although some LOC forms correctly state that wishes expressed are not consent to treatment, it would appear that LOC forms are used as consents or used to limit treatment options because health care staff and health practitioners in those homes assume that these forms record consents.

The alternative to LOC forms is changing practices to ensure that plans of treatments are developed for all residents that include treatments such as CPR/ No CPR and that informed consent is obtained for all treatments and plans of treatments.

Advance care planning is not just about end of life care.

Any adult (age 16 or older) needs to understand who would be their SDM if he or she was not able to provide their own consents to health care. All adults have the right to choose someone to be their SDM if they want someone other than their automatic SDM as in the SDM hierarchy in the Health Care Consent Act. [35]  

Advance care planning wishes may be about anything related to health care and may include information about the person’s value and beliefs that influence how they may decisions about health care. The advance care planning wishes are not limited to health care and values and beliefs about health care just at end of life.  [36]

Advance care planning wishes are expressed to help prepare the person’s SDM to make decisions for the person whenever that person may lack capacity to make health care decisions and needs a SDM. That need may arise at any time over the course of a person life.

• [35] Health Care Consent Act, s.20
• [36] Health Care Consent Act, s.5

Advance care planning and health care consent are closely related. Advance care planning is done to help the patient and their SDM understand the health practitioner’s duty to get consent before treatment from the patient if capable and how the patient can prepare for an SDM to give or refuse that consent if the patient should become incapable.

Health care practitioners must always obtain informed consent or refusal of consent from either the mentally capable patient or their substitute decision maker (SDM) before providing treatment  [37]

Advance care planning is done to prepare the patient’s future SDM to give or refuse consent to health care on behalf of the patient if the patient is not capable to speak for themselves at some future date. ACP is done to support better decision-making for the patient in the consent process.

A summary of what patients, SDMs, and health practitioners need to know about advance care planning and health care consent to understand this connection is as follows:

• there is a  requirement for health practitioners to get an informed consent from before any treatment is provided
• a patient is their own decision maker if capable [38]  
• the health practitioner must turn to the person’s SDM for any health decisions if the patient is incapable for a health decision  [39]
• the patient has an automatic SDM by law even if he or she has done no advance care planning. If the patient  wants another person to be their health decision maker then they must prepare a POA Personal care  [40]
• the patient can prepare their future SDM (SDMs) to make decisions for them by talking with the SDM about the patients  “wishes, values, beliefs” [41]  that affect how the patient makes their own health decisions. These conversations are to help the future SDM “step into the shoes” of the patient when the SDM has to make decisions for that patient.
• ACP wishes don’t have to be specific statements about treatments the person would want or not want. It is often not possible to give specific directions about specific treatments because it is hard to predict exactly what health problems a person may have in the future. ACP wishes are not advance health decisions but are information that will be used by the patient’s SDM to make health decisions for that person should the person becomes incapable.
• By having conversations with their future SDM, the person is helping the SDM understand how the person makes their own health decisions – what is important to them in their own life, what is quality of life. The conversations are to help prepare the SDM to be confident in the decisions they may have to make for the person when incapable.
• When the SDM is required to step in and make decisions for the person, the SDM is required to honour the wishes, values and beliefs of that person expressed to the SDM when the person was capable. The SDM must apply the person’s wishes values and beliefs when considering what decisions to make for that person [42] .
• If the SDM is not aware of wishes that are applicable to the particular decision to be made then the SDM is required to act in the best interests of the person  [43]
• Best interests involves the SDM considering the values and beliefs that the SDM knows the incapable person held when capable and believes he or she would still act on if capable as well as considering whether the incapable person’s condition or well-being is likely to improve, remain the same or deteriorate without the treatment. Best interests include weighing the risks and benefits of the treatment options.
• SDMs do not have to follow a wish that is impossible to honour. For example, a person may communicate to their future SDM that they want to live in their own home and not a long term care home or that they want to die in their own home but these types of wishes may be impossible to honour depending on the actual state of health of the person, their care needs, the availability of public and private home care, the person’s financial resources, and the availability of family and others to care for the person in their own home.
• [37] Health Care Consent Act, s.10(1)
• [38] Health Care Consent Act, s.10(1)
• [39] Health Care Consent Act, s.10(1)
• [40] Health Care Consent Act, s.20
• [41] Health Care Consent Act, s.5
• [42] Health Care Consent Act, s.21(1)
• [43] Health Care Consent Act, s.21(2)

Consents to treatment [44]  are decisions made by a patient when capable or the incapable patient’s SDM after a health practitioner has provided the patient or the SDM with information about the patient’s current health condition and the risks, benefits, side effects of any proposed treatments, alternatives to these treatments and what would happen if the treatments offered were refused.

In contrast ACP wishes [45]  about future care are NOT decisions (informed consent) to treatments or care.  When a person communicates ACP wishes, he or she is thinking about what their health condition may be in the future and what health care they may or may not want. When a person expresses advance care planning wishes, he or she does not yet know what their health condition will be, or what care options might be available.

ACP wishes are not “advance consent”.  Consent can only be given after a person has all the information to make a decision. This cannot be done in advance.

ACP discussions between a person and their future SDM prepare SDMs for when the person is incapable and the SDM must step in to make the informed consent decisions for the incapable person.  

Before making a decision on behalf of the incapable person, the SDM must be given the same information that the patient would have been given if still capable about the patient’s current condition and treatments options. [46]  The SDM then uses the advance care planning wishes and their knowledge of the patient’s values and beliefs to then make a decision on behalf of the patient, The SDM applies that information from the ACP process to inform their decisions on behalf of the patient.

• [44] Health Care Consent Act, s.11
• [45] Health Care Consent Act, s.5
• [46] Health Care Consent Act, s.22

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Substitute Decision Maker(s)

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• Health Info

Periodontal (Gum) Disease

On this page, helpful tips, additional resources, related publications.

Periodontal (gum) disease is an infection of the tissues that hold your teeth in place. It's typically caused by poor brushing and flossing habits that allow plaque—a sticky film of bacteria—to build up on the teeth and harden. It starts with swollen, red, and bleeding gums. If left untreated, it can spread to the bones surrounding the gums, making it painful to chew. In the worst cases, teeth may become loose or need to be removed.

Ask the Expert

Timothy J. Iafolla, DMD, MPH answers all your questions about flossing. Read the interview here .

Dental plaque that is not removed every day can harden and form tartar, and tartar build-up can lead to gum disease. Only a professional cleaning by a dentist or dental hygienist can remove tartar.

There are several risk factors for gum disease, but smoking is the most significant. Smoking also can make treatment for gum disease less successful. Other risk factors include hormonal changes in girls and women; certain illnesses, such as diabetes or AIDS and their medications; and genetics.

Symptoms of gum disease can affect various areas of the mouth.

At a dental visit, a dentist or dental hygienist will perform tests to diagnose periodontal disease:

Your dental professional may also refer you to a periodontist, a specialist in the diagnosis and treatment of gum disease, who may provide other treatment options not provided by your dentist.

The main goal of treatment is to control the infection. The number and types of treatments will vary, depending on the extent of the gum disease. Any type of treatment requires that the patient keep up good daily care at home. The dentist may also suggest changing certain behaviors, such as quitting smoking, as a way to improve your treatment results.

You can keep your gums and teeth healthy by:

• Brushing your teeth twice a day with a fluoride toothpaste.
• Flossing regularly to remove plaque from between teeth. Or, you can use a device such as an interdental (between-the-teeth) brush , a wooden or plastic pick, or a “water flosser” recommended by a dental professional.
• Visiting the dentist routinely for a check-up and professional cleaning.
• Quitting smoking.
• Periodontal Disease Information from the Centers for Disease Control and Prevention about the causes of periodontal disease, its warning signs, risk factors, and prevention and treatment.
• MedlinePlus: Gum Disease The NIH National Library of Medicine's collection of links to government, professional, and non-profit/voluntary organizations with information on periodontal disease and gingivitis.
• How to Quit Smoking Information from the Centers for Disease Control and Prevention (CDC) on quitting smoking.

Fact sheet on maintaining oral health for a lifetime.

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Periodontal (Gum) Disease Research from NIDCR

• Healthy Mouth, Healthy Body
• Gum Cells Detect Shift in Mouth Microbes That May Trigger Inflammation, Gum Disease
• Probing Periodontal Disease
• Researchers Call in a Swarm of Tiny, Tooth-Scrubbing Robots
• The Gut’s Role in Oral Bone Health
• Disarming a Blood-Clotting Protein Prevents Gum Disease in Mice
• Tooth Protein Prevents Bone Loss in Mice
• A Census Inside Your Mouth
• Turning Back the Clock on Gum Disease
• Genes Are Key to Oral Health & Beyond

First Cancer TIL Therapy Gets FDA Approval for Advanced Melanoma

March 5, 2024 , by Carmen Phillips

FDA has approved the first treatment for cancer that uses tumor-infiltrating lymphocytes, or TILs.

In an event more than three decades in the making, the Food and Drug Administration (FDA) has approved lifileucel (Amtagvi), the first treatment for cancer that uses immune cells called tumor-infiltrating lymphocytes, or TILs. Announced on February 16, the agency’s decision also makes lifileucel the first cellular therapy to be approved for a solid tumor , the skin cancer melanoma.

The agency’s accelerated approval covers the use of lifileucel for people with advanced melanoma that has gotten worse after treatment with certain immunotherapy drugs or targeted therapies.

As is the case with CAR T-cell therapy , another type of cellular therapy, lifileucel is made using a patient’s own T cells . And with both therapies, the cells are collected at the hospital where the patient is being treated but are sent away to be manufactured into the final treatment. 

But there’s a key difference between TILs and CAR T-cell therapies.

For the approved CAR T-cell therapies, the T cells are collected from a patient’s circulating blood. For TIL therapy, by contrast, the T cells are collected from the patient’s tumor. 

Lifileucel’s approval was based on findings from a clinical trial sponsored by Iovance Biotherapeutics. Among more than 70 participants who were treated with the lifileucel dose ultimately approved by FDA, nearly one-third had at least some reduction in the size of their tumors (a tumor response), with tumors disappearing completely (a complete response ) in several participants.

Moreover, about 40% of those whose cancer responded to lifileucel still had no progression of their cancer a year after receiving the one-time infusion treatment. 

TIL therapy was pioneered by Steven Rosenberg, M.D., and his colleagues in NCI’s Surgery Branch . In the late 1980s, Dr. Rosenberg led the first-ever clinical trials of TIL therapy, showing that it could shrink tumors in people with very advanced melanoma. (Dr. Rosenberg was recently given the nation’s highest award for technology and innovation for his work on immunotherapy , including the development of TIL therapy.)

Over the ensuing years, the NCI researchers further refined the process for manufacturing and delivering TIL therapy. In 2011, NCI entered into a cooperative research agreement with Iovance to further develop this particular TIL therapy, including conducting larger clinical trials and developing a manufacturing infrastructure, paving the way for FDA approval.

It’s been a long time coming, Dr. Rosenberg acknowledged. The new approval “is a big step,” he said, one which demonstrates that “cellular therapy is joining the mainstream of cancer treatment.”

TILs that just need a little help

Six different CAR T-cell therapies have been approved by FDA, all of which are used to treat blood cancers like leukemia and lymphoma.

With CAR T-cell therapy, the collected immune cells undergo genetic engineering in the laboratory to give them the ability to recognize cancer cells and enhance their ability to kill them. Next, they are grown, or expanded, into the hundreds of millions, and then infused into the patient.

Tumor-infiltrating lymphocytes, or TILs, are T cells collected from a patient's own tumor. Once isolated from the tumor sample, the TILs are expanded into the billions and infused back into the patient.

With lifileucel, the collected T cells are not engineered before being expanded. That’s because, having been collected from samples of tumor tissue, they’ve already proven that they can recognize and navigate to tumors, Dr. Rosenberg explained. That recognition relies on the presence of specific abnormal proteins , or antigens , on the surface of the tumor cells.

But, like a robber who sneaks into a bank but doesn’t have the tools to open the safe, the collected TILs lack the ability or support required to complete the job. What the TILs need are reinforcements—a lot of them—and some encouragement.

So, although the TILs collected from a patient’s tumor are not genetically changed, there are steps taken during the manufacturing process—including mixing them with a drug called IL-2 —to help them expand into billions of cancer-fighting immune cells.

In addition, as part of lifileucel treatment, two measures are taken to enhance the infused TILs ability to attack the cancer and their overall potency. First, in the days prior to receiving lifileucel, patients undergo a few rounds of high-dose “lymphodepleting” chemotherapy. And, second, shortly after the lifileucel infusion, they are given several doses of IL-2.

Long-lasting tumor responses to lifileucel

FDA’s approval was based on data from a group of 73 patients in the trial whose cancer had gotten worse despite treatment with a PD-1 / PD-L1 -targeted immune checkpoint inhibitor or a BRAF inhibitor and whose lifileucel dose was at least 7.5 billion cells (the dose specified in the approval).

Longer-term findings from a larger group of 153 patients in the trial were reported in December 2023 at the European Society of Medical Oncology’s (ESMO) 2023 Immuno-Oncology Congress, and they largely mirror the findings from these 73 patients.

Of the 48 people (31.5%) whose cancer responded to treatment with lifileucel, more than half have lived at least a year without any evidence of their cancer getting worse . About 10% of these responses are ongoing—that is, there continues to be no evidence that their cancer is getting worse—and nearly all have lasted several years.

The longest lasting response is nearly 5 years, one of the trial’s lead researchers, Martin Wermke, M.D., Ph.D., of the University of Dresden in Germany, reported at the ESMO meeting.

The researchers plan to follow all patients for 5 years from the time of their lifileucel infusion, Dr. Wermke said. Based on the results thus far, he continued, the researchers anticipate that cancer will not get worse or come back in any participants with ongoing responses.

Who will respond to lifileucel? What about side effects?

There are some hints from the results in the larger patient group that might help identify who is most likely to respond to lifileucel, Dr. Wermke explained.

For example, few people whose cancer had spread to the brain or liver, which was the case for about half of the 153 patients, responded. Responses were also unlikely in people who had larger tumor burdens—that is, a substantial amount of cancer in their body.

These findings, he noted, suggest that lifileucel might be most effective if it’s given before the cancer has spread to many other parts of the body or individual tumors have become quite large.

All participants in the trial had side effects caused by the treatment, Dr. Wermke reported. Most, however, were not dangerous and were largely caused by the chemotherapy given before the lifileucel infusion and IL-2 given afterward. The most common included anemia , high fevers, and substantial drops in levels of platelets and certain white blood cells . 

TIL therapy does not appear to cause the often serious immune-related side effects commonly seen in people treated with CAR T-cell therapy, including cytokine release syndrome and neurologic effects, Dr. Wermke said.

He also stressed that the side effects seen in the trial had a consistent and familiar pattern.

“They’re all occurring during the first 2 or 3 weeks” after someone receives the treatment, he said.  “There are hardly any new [side effects] occurring in the long term,” he said.

From clinical trials to using TILs in everyday cancer care

Iovance announced that it has approved more than 30 treatment centers across the United States to collect tumor samples for making lifileucel and administering the final treatment to patients. There are expected to be 50 such centers by the end of May. 

Initially, all treatments will be manufactured at an Iovance facility or a contracting facility, both in Philadelphia.

One CAR T-Cell Therapy for Blood Cancers?

Using CRISPR, researchers have developed a potential “universal” immunotherapy for blood cancers like leukemia and lymphoma.

According to the company, a single treatment with lifileucel will cost $515,000. During a company webcast held after the approval, Iovance officials said they expect that many insurance companies will cover the treatment at the same levels as they have for CAR T-cell therapies, which also cost hundreds of thousands of dollars. The company has also established a financial assistance program for patients.

William Sharfman, M.D., a co-director of the melanoma program at the Johns Hopkins Sidney Kimmel Cancer Center, said the approval is “very exciting” news for people with advanced melanoma.

But, Dr. Sharfman cautioned, “there are several limiting factors” for using lifileucel in patients.

Among them, he said, is that patients need to be relatively healthy to receive it, which isn’t always the case for people with advanced cancer who have undergone other treatments. 

“Patients really need to have normal heart and lung function,” he said.

Alexander Shoushtari, M.D., of Memorial Sloan Kettering Cancer Center, who studies cellular therapies, agreed that practical considerations may limit lifileucel’s use. 

“The relatively high doses of … chemotherapy given before treatment and the high dose Interleukin-2 after [lifileucel] infusion currently limit the types of people who can undergo it,” Dr. Shoushtari said. 

After lifileucel approval, what comes next?

FDA’s approval for melanoma is only the first step for lifileucel. Iovance has already started enrolling participants in a large trial combining lifileucel with the immunotherapy drug pembrolizumab (Keytruda) as an initial treatment for advanced melanoma.

Lifileucel is also well along in testing as a treatment for other cancers, including showing promising tumor responses in people with advanced lung cancer , as well as ovarian and head and neck cancers.

Dr. Rosenberg’s lab and others are testing newer forms of TIL-based therapies in clinical trials, and not just for melanoma, but for other solid cancers.

“There are clear examples where TIL therapy has caused regression of [other solid] tumors,” Dr. Rosenberg said. That includes complete eradication of tumors in individual patients with advanced colon cancer and advanced breast cancer treated in clinical trials at the NIH Clinical Center. 

With this “landmark approval” in hand, there is a lot of optimism surrounding TIL therapy and cellular therapy more broadly, Dr. Shoushtari said. “I expect that this [approval] will be the tip of the iceberg for cellular-based immune therapy for solid tumors,” he added. 

The first-generation TILs like lifileucel are “an important advance and proof of concept” that these treatments can be highly effective, he said. “But much remains to be done to broaden [their] use, both for other cancer types and to a broader range of people with melanoma.”

Dr. Sharfman agreed. “That is the challenge: to design better TILs.”

Researchers are already taking up this challenge, include finding ways to make TILs that are more potent and that can be used in a broader range of solid tumors. Dr. Rosenberg’s group at NCI, for example, has developed a process for identifying TILs that strongly recognize a tumor and are most likely to attack it.

Researchers have also begun genetic engineering of TILs, with the goal of increasing the number of people who respond to the treatment or eliminating the need for the pre-infusion chemotherapy or post-infusion IL-2. 

Dr. Rosenberg stressed that the decades of research on cancer cellular therapies by his and other groups has paved the way for rapid advances.

“We now have the knowledge of how to help the immune system target tumors,” particularly the solid tumors “that are responsible for the vast majority of cancer deaths,” he said. “There is a world of opportunities out there.”

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Inflation Reduction Act   Guidebook

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On August 16, 2022, President Biden signed the Inflation Reduction Act into law, marking the most significant action Congress has taken on clean energy and climate change in the nation’s history. With the stroke of his pen, the President redefined American leadership in confronting the existential threat of the climate crisis and set forth a new era of American innovation and ingenuity to lower consumer costs and drive the global clean energy economy forward.

This guidebook provides an overview of the clean energy, climate mitigation and resilience, agriculture, and conservation-related investment programs in President Biden’s Inflation Reduction Act, including who is eligible to apply for funding and for what activities.

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