(a therapeutic question)
While formulating your research question, it's also important to consider the type of question you are asking because this will affect the type of studies (or study design ) to be included in your review.
Each type of question defines its type of studies in order to provide the best evidence. For example, to answer a therapeutic question, you need to include as many Randomized Controlled Trials (RCTs) as possible, because RCTs are considered to have the highest level of evidence (least bias) for solving a therapeutic problem.
The table below suggests the best designs for specific type of question. The Level of Evidence pyramid, which is widely adopted in the medical research area, shows a hierarchy of the quality of medical research evidence in different type of studies ( Level of Evidence (2011), Oxford Centre for Evidence-based Medicine, CEBM ).
Type of Question | Ideal Type of Study (or Study Design) | Level of Evidence |
Therapy / Intervention | > Cohort Study > Case Control Study > Case Series | |
Diagnosis | (with consistently applied reference standard and blinding) | |
Prognosis | > Case Control Study > Case Series | |
Etiology / Harm | RCT > Cohort Study > Case Control Study > Case Series |
Usually, the study design of a research work will be clearly indicated either in its title or abstract, especially for RCT. Some databases also allow to search or refine results to one or a few study designs, which helps you locate as many as possible the relevant studies. If you are not sure the study design of a research work, refer to this brief guide for spotting study designs (by CEBM).
Learn to build a good clinical question from this EBP Tutorial: Module 1: "Introduction to Evidence-Based Practice"
It is provided by Duke University and University of North Carolina at Chapel Hill, USA.
PICO Framework and the Question Statement The above named section in the Library guide: Evidence-Based Practice in Health , provided by the University of Canberra Library, explains the PICO framework with examples and in various question types.
Systematic review requires a detailed and structured reporting of the search strategy and selection criteria used in the review. Therefore we strongly advise you to document your search process from the very beginning. You may use this workbook to help you with the documentation.
The documentation should include:
and the whole search process, including:
Eventually, you will need to include the information above when you start writing your review. A highly recommended structure for reporting the search process is the PRISMA Flow Diagram . You may also use PRISMA Flow Diagram Generator to generate a diagram in a different format (based on your input).
A systematic review aims to answer a clear and focused clinical question. The question guides the rest of the systematic review process. This includes determining inclusion and exclusion criteria, developing the search strategy, collecting data and presenting findings. Therefore, developing a clear, focused and well-formulated question is critical to successfully undertaking a systematic review.
A good review question:
Types of clinical questions
Research topic vs review question
A research topic is the area of study you are researching, and the review question is the straightforward, focused question that your systematic review will attempt to answer.
Developing a suitable review question from a research topic can take some time. You should:
When considering the feasibility of a potential review question, there should be enough evidence to answer the question whilst ensuring that the quantity of information retrieved remains manageable. A scoping search will aid in defining the boundaries of the question and determining feasibility.
For more information on FINER criteria in systematic review questions, read Section 2.1 of the Cochrane Handbook .
Check for existing or prospective systematic reviews
Before finalising your review question, you should determine if any other systematic review is in progress or has been completed on your intended question (i.e. consider if the review is N ovel).
To find systematic reviews you might search specialist resources such as the Cochrane Library , Joanna Briggs Institute EBP Database or the Campbell Collaboration . "Systematic review" can also be used as a search term or limit when searching the recommended databases .
You should appraise any systematic reviews you find to assess their quality. An article may include ‘systematic review’ in its title without correctly following the systematic review methodology. Checklists, including those developed by AMSTAR and JBI , are useful tools for appraisal.
You may undertake a review on a similar question if that posed by a previously published review had issues with its methodology such as not having a comprehensive search strategy, for example. You may choose to narrow the parameters of a previously conducted search or to update the review if it was published some years ago.
Searching a register of prospective systematic reviews such as PROSPERO will allow you to check that you are not duplicating research already underway.
Once you have performed scoping searches and checked for other systematic reviews on your topic, you can focus and refine your review question. Any PICO elements identified during the initial development of the review question from the research topic should now be further refined.
The review question should always be:
Work through the first section of the to define your review question |
Review questions may be broad or narrow in focus; however, you should consider the FINER criteria when determining the breadth of the PICO elements of your review question.
A question that is too broad may present difficulty with searching, data collection, analysis, and writing, as the number of studies retrieved would be unwieldy. A broad review question could be more suited to another type of review .
A question that is too narrow may not have enough evidence to allow you to answer your review question. Table 2.3.a in the Cochrane Handbook summarises the advantages and disadvantages of broad versus narrow reviews and provides examples of how you could broaden or narrow different PICO elements.
It is essential to formulate your research question with care to avoid missing relevant studies or collecting a potentially biased result set.
A systematic review protocol is a document that describes the rationale, question, and planned methods of a systematic review. Creating a protocol is an essential part of the systematic review process, ensuring careful planning and detailed documentation of what is planned before undertaking the review.
The Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) checklist outlines recommended items to address in a systematic review protocol, including:
The has been designed to help you create your systematic review protocol |
Systematic reviews must have pre-specified criteria for including and excluding studies in the review. The Cochrane Handbook states that "predefined, unambiguous eligibility criteria are a fundamental prerequisite for a systematic review."
The first step in developing a protocol is determining the PICO elements of the review question and how the intervention produces the expected outcomes in the specified population. You should then specify the types of studies that will provide the evidence to answer your review question. Then outline the inclusion and exclusion criteria based on these PICO elements.
For more information on defining eligibility criteria, see Chapter 3 of the Cochrane Handbook .
A key purpose of a protocol is to make plans to minimise bias in the findings of the review; where possible, changes should not be made to the eligibility criteria of a published protocol. Where such changes are made, they must be justified and documented in the review. Appropriate time and consideration should be given to creating the protocol.
You may wish to register your protocol in a publicly accessible way. This will help prevent other people from completing a review on your topic.
If you intend to publish a systematic review in the health sciences, it should conform to the IOM Standards for Reporting Systematic Reviews .
If you intend to publish a systematic review in the Cochrane Database of Systematic Reviews , it should conform to the Methodological Expectations in Cochrane Intervention Review s (MECIR).
A clinical question needs to be directly relevant to the patient or problem and phrased to facilitate the search for an answer. A clear and focused question is more likely to lead to a credible and useful answer, whereas a poorly formulated question can lead to an uncertain answer and create confusion.
The population and intervention should be specific, but if any or both are described too narrowly, it may not be easy to find relevant studies or sufficient data to demonstrate a reliable answer.
Question type | Explanation | Evidence types required to answer the question |
---|---|---|
Diagnosis | Questions about the ability of a test or procedure to differentiate between those with and without a disease or condition | Randomised controlled trial (RCT) or cohort study |
Etiology (causation) | Questions about the harmful effect of an intervention or exposure on a patient | Cohort study |
Meaning | Questions about patients' experiences and concerns | Qualitative study |
Prevention | Questions about the effectiveness of an intervention or exposure in preventing morbidity and mortality. Questions are similar to treatment questions. When assessing preventive measures, it is essential to evaluate potential harms as well as benefits | Randomised controlled trial (RCT) or prospective study |
Prognosis (forecast) | Questions about the probable cause of a patient's disease or the likelihood that they will develop an illness | Cohort study and/or case-control series |
Therapy (treatment) | Questions about the effectiveness of interventions in improving outcomes in patients suffering from an illness, disease or condition. This is the most frequently asked type of clinical question. Treatments may include medications, surgical procedures, exercise and counselling about lifestyles changes | Randomised controlled trial (RCT) |
PICO is a framework for developing a focused clinical question.
Slightly different versions of this concept are used to search for quantitative and qualitative reviews, examples are given below:
PICO for quantitative studies
What are the characteristics of the opulation or atient?
| How do you wish to ntervene? What do you want to do with this patient - treat, diagnose, observe, etc.? | What is the omparison or alternative to the intervention - placebo, different drug or therapy, surgery, etc.? | What are the possible utcomes - morbidity, death, complications, etc.? |
Here is an example of a clinical question that outlines the PICO components:
PICo for qualitative studies
P | I | Co |
---|---|---|
What are the characteristics of the opulation or atient?
| nterest relates to a defined event, activity, experience or process | ntext is the setting or distinct characteristics |
Here is an example of a clinical question that outlines the PICo components:
Two other mnemonics may be used to frame questions for qualitative and quantitative studies - SPIDER and SPICE .
SPIDER for qualitative or quantitative studies
SPIDER can be used for both qualitative and quantitative studies:
ample size may vary in quantitative and qualitative studies | henomena of nterest include behaviours, experiences and interventions | esign influences the strength of the study analysis and findings | valuation outcomes may include more subjective outcomes such as views, attitudes, etc. | esearch types include qualitative, quantitative, or mixed-method studies |
Within social sciences research, SPICE may be more appropriate for formulating research questions:
etting is the context for the question - | erspective is the users, potential users or stakeholders of the service - | ntervention is the action taken for the users, potential users or stakeholders - | omparison is the alternative actions or outcomes - | valuation is the result or measurement that will determine the success of the intervention - or |
More question frameworks
For more question frameworks, see the following:
Why use pico.
Systematic reviews require focused clinical questions. PICO is a useful tool for formulating such questions. For information on PICO and other frameworks please see our tutorial below.
Systematic Reviews: Formulating the Research Question [PDF, 191kB]
This PowerPoint covers:
The PICO (Patient, Intervention, Comparison, Outcome) framework is commonly used to develop focused clinical questions for quantitative systematic reviews.
atient, opulation or roblem | |
ntervention or exposure | |
omparison | |
utcome |
Sample topic:
In middle aged women suffering migraines, is Botulinium toxin type A compared to placebo effective at decreasing migraine frequency?
P - Middle aged women suffering migraines
I - Botulinium toxin type A
C - Placebo
O - Decreased migraine frequency
Use the following worksheet to complete a search strategy:
PICO SR worksheet [DOCX, 17kB]
Completed PICO SR worksheet [PDF, 114kB]
The PICO (Patient, Intervention, Comparison, Outcome) framework is commonly used to develop focused clinical questions for quantitative systematic reviews. A modified version, PICo , can be used for qualitative questions.
opulation | |
nterest | |
ntext |
What are caregivers’ experiences with providing home-based care to patients with HIV/AIDS in Africa?
P - Caregivers providing home-based care to persons with HIV/AIDS
I - Experiences
Co - Africa
Use the following worksheet to create a search strategy:
PICo qualitative worksheet [DOCX, 18kB]
Completed PICo Qualitative worksheet [PDF, 115kB]
The SPIDER framework is an alternative search strategy tool (based on PICo) for qualitative/mixed methods research.
ample | |
henomenon of nterest | |
esign | |
valuation | |
esearch type |
What are the experiences of women undergoing IVF treatment?
PI - IVF treatment
D - Questionnaire or survey or interview
E - Experiences or views or attitudes or feelings
R - Qualitative or mixed method
Cooke, A., Smith, D., & Booth, A. (2012). Beyond PICO: The SPIDER tool for qualitative evidence synthesis
Methley, A. M., Campbell, S., Chew-Graham, C., McNally, R., & Cheraghi-Sohi, S. (2014). PICO, PICOS and SPIDER: A comparison study of specificity and sensitivity in three search tools for qualitative systematic reviews
SPICE can be used for both qualitative and quantitative studies. SPICE stands for S etting (where?), P erspective (for whom?), I ntervention (what?), C omparison (compared with what?) and E valuation (with what result?).
What are the coping skills of parents of children with autism undergoing behavioural therapy in schools?
S - Schools
P - Parents of children with autism
I - Behavioural therapy
E - Coping skills
Booth, A. (2006). Clear and present questions: Formulating questions for evidence based practice
Pico for quantitative studies, pico for qualitative studies, other frameworks (for qualitative studies), further reading.
The first key stage of a systematic review would be to formulate a focused, answerable research question . A well-defined and clear research question is an essential starting point for a systematic search. To create a logical search strategy, always start by identifying the key elements of the research question - i.e., establish what the main concepts of the topic are. With these concepts, you can then create the search blocks that form the basis for the search strategies used in the different databases.
Use the PICO framework to translate the research question into search concepts that can be applied in a structured search strategy. In general, you should not use all parts of the PICO question in the search. The key focus of the search would be generally on the P (Population / Patient / Problem) and the I (Intervention), and sometimes C (Comparison intervention) if the volume of search results is too great, or the concept is exceptionally clear and regularly reported.
Karolinska Institutet University Library (2022). Systematic reviews [ Systematic Search Technique s] : https://kib.ki.se/en/search-evaluate/systematic-reviews
The patient, population or problem which the question applies to. | Drugs, surgical and therapeutic procedures being evaluated. | What is the alternative intervention? (e.g. placebo, different drug, surgery, gold standard) | The clinical outcomes of interest. |
An example of the use of PICO (Quantitative)
Formulate a clear and focused PICO question. An example of an initial unfocused question would be: Is caffeine effective in preventing daytime drowsiness (DTD)?
A focused clinical question would be: Among adults with a history of DTD, does a cup of caffeinated coffee in the morning improve alertness? A question is made focused by clearly specifying the PICO elements...
adults with a history of DTD |
A cup of caffeinated coffee in the morning |
No caffeinated coffee (implied) |
Alertness |
Dr Lorraine Tudor Car. 1.2 Focused Question & the Parallel Group RCT Design.
What are the characteristics of the atient or opulation? What is the condition or disease you are interested in? | The phenomena of nterest relates to a defined event, activity, experience or process | ntext is the setting or distinct characteristics. |
Murdoch University Library. [2022]. Using PICO or PICo - Systematic Reviews: https://libguides.murdoch.edu.au/systematic/PICO .
An example of a qualitative research question: Do mindfulness programs improve the academic, behavioral, and socio-emotional functioning of primary and secondary students?
Let's apply this to the SPIDER framework.
Pre-school, primary and secondary students | ||
| Mindfulness programs | |
Quasi-experimental design (QED) | ||
Socio-emotional outcomes Behavioral outcomes Academic outcomes | ||
Mixed Methods |
Another example of a qualitative research question: What is the effect of climate change on the seed quality of legume crops?
Let's apply this to the SPICE framework.
(where?) | n/a (global - all countries) | |
(for who or what?) | Legumes | |
(phenomenon of interest) | Elevated CO2 | |
No elevation in CO2 | ||
(Outcome) | Seed mass Germination Seed vigour |
Steven Chang (La Trobe University). Systematic Searching for Systematic Reviews.
St Joseph's Health Centre Toronto. Study Design [Matching Question Types with Study Design]. https://library.stjoestoronto.ca/home/ebm/studydesign
Elsevier Author Services. FINR : a Research Framework. https://scientific-publishing.webshop.elsevier.com/research-process/finer-research-framework/
You are expected to comply with University policies and guidelines namely, Appropriate Use of Information Resources Policy , IT Usage Policy and Social Media Policy . Users will be personally liable for any infringement of Copyright and Licensing laws. Unless otherwise stated, all guide content is licensed by CC BY-NC 4.0 .
This video illustrates how to use the PICO framework to formulate an effective research question, and it also shows how to search a database using the search terms identified. The database used in this video is CINAHL but the process is very similar in databases from other companies as well.
A longer on the important pre-planning and protocol development stages of systematic reviews, including tips for success and pitfalls to avoid.
* You can start watching this video from around the 9 minute mark.*
Having a focused and specific research question is especially important when undertaking a systematic review. If your search question is too broad you will retrieve too many search results and you will be unable to work with them all. If your question is too narrow, you may miss relevant papers. Taking the time to break down your question into separate, focused concepts will also help you search the databases effectively.
Deciding on your inclusion and exclusion criteria early on in the research process can also help you when it comes to focusing your research question and your search strategy.
A literature searching planning template can help to break your search question down into concepts and to record alternative search terms. Frameworks such as PICO and PEO can also help guide your search. A planning template is available to download below, and there is also information on PICO and other frameworks ( Adapted from: https://libguides.kcl.ac.uk/systematicreview/define).
Looking at published systematic reviews can give you ideas of how to construct a focused research question and an effective search strategy.
Example of an unfocused research question: How can deep vein thrombosis be prevented?
Example of a focused research question: What are the effects of wearing compression stockings versus not wearing them for preventing DVT in people travelling on flights lasting at least four hours.
In this Cochrane systematic review by Clarke et al. (2021), publications on randomised trials of compression stockings versus no stockings in passengers on flights lasting at least four hours were gathered. The appendix of the published review contains the comprehensive search strategy used. This research question has focused on a particular method (wearing compression stockings) in a particular setting (flights of at least 4 hrs) and included only specific studies (randomised trails). An additional way of focusing a question could be to look at a particular section of the population.
Clarke M. J., Broderick C., Hopewell S., Juszczak E., and Eisinga A., 20121. Compression stockings for preventing deep vein thrombosis in airline passengers. Cochrane Database of Systematic Reviews 2021, Issue 4. Art. No.: CD004002 [Accessed 30th April 2021]. Available from: 10.1002/14651858.CD004002.pub4
There are many different frameworks that you can use to structure your research question with clear parameters. The most commonly used framework is PICO:
Adapted from: https://libguides.reading.ac.uk/systematic-review/protocol
As well as PICO, there are other frameworks available, for instance:
This page from City, University of London, contains useful information on several frameworks, including the ones listed above.
Atfer you have created your research question, the next step is to develop a protocol which outlines the study methodology. You need to include the following:
To find out how much has been published on a particular topic, you can perform scoping searches in relevant databases. This can help you decide on the time limits of your study.
It is good practice to register your protocol and often this is a requirement for future publication of the review.
You can register your protocol here:
Adapted from: https://libguides.bodleian.ox.ac.uk/systematic-reviews/methodology
On the Systematic Review Request form you will be asked to outline your research question in PICO format. This allows us to easily understand the main concepts of your research question. Here is what PICO stands for:
P = Problem/Population
I = Intervention (or the experimental variable)
C = Comparison (or the control variable) [Optional]
O = Outcome
If your research question does not fit neatly into PICO that is okay. Just try to include the elements of your question as closely as possible into the format. Your collaborating librarian will discuss any questions or concerns about your research topic before putting together your systematic review search strategy.
What is a systematic review.
Before diving into the meaning of a PICO framework systematic review, it is important to have a quick overview of the meaning of a systematic review. You have probably come across the hierarchy of evidenc e, which is used to rank the strength of evidence obtained from research studies to power clinical decision-making. Systematic reviews (and meta-analyses) are usually placed at the top of the pyramid as the highest level of evidence. For this reason, many universities are accepting systematic reviews and meta-analyses for undergraduate, masters, and PhD dissertations. Similarly, many reputable academic journals are accepting systematic reviews and meta-analyses as a source of credible evidence for publications.
Table of Contents
A systematic review is the highest level of evidence, especially in clinical sciences. It aims to answer focused clinical questions to power evidence-based clinical decision-making by collating findings from various empirical studies. These empirical studies must meet a pre-specified eligibility criteria. Therefore, when doing a systematic review, the first step is to formulate a research question . That is where the idea of a PICO framework emerges.
In summary, when formulating a research question to be answered using a systematic review methodology, you must follow a specified structure. One of the frameworks commonly employed in formulating systematic review research questions is the PICO framework. Similarly, the empirical studies whose findings are collated in a systematic review must meet pre-specified eligibility criteria. Also, the PICO framework is used in guiding the formulation of these eligibility criteria. Therefore, before describing the specific meaning of the PICO framework, it is important to note its two functions in systematic reviews, namely (a) framing research questions and (b) formulating eligibility criteria. The PICO framework is recommended by the Cochrane Collaboration in framing research questions and formulating eligibility criteria.
A PICO Framework systematic review refers to a systematic review or meta-analysis that relies on the PICO process.
The “P” element of PICO refers to the target population of your research. For example, you could be focusing on adults diagnosed with diabetes. In your research question, you must indicate that you systematic review is focusing on adults diagnosed with diabetes. Similarly, in your eligibility criteria, you must indicate that you’re selecting only empirical studies that used adults diagnosed with diabetes in their sample. Thus, studies that use a sample of children or adolescents diagnosed with diabetes may not meet your eligibility criteria.
The “I” element of PICO defines the intervention whose effects you’re investigating in your systematic review. For example, as a clinician or researcher, you might be interested in understanding the effectiveness of interventions derived from self-determination theory for adults diagnosed with diabetes . In this regard, the specific interventions are not yet identified. In that case, you can add an objective to your systematic review about identifying or summarizing interventions derived from the self-determination theory. Therefore, in your eligibility criteria, you must also mention that you’re only focusing on interventions derived from the self-determination theory. In other words, studies to be selected in your systematic review must focus on investigating such interventions.
The “C” element of a PICO framework outlines the comparison. In this case, the comparison refers to the alternative that you’re comparing your intervention against. Take the example of a systematic review investigating the effectiveness of interventions derived from the self-determination theory. For you to determine whether such interventions are effective, you can compare them with usual or routine care. If the intervention shows better effectiveness than usual or routine care, you can recommend it in your systematic review.
Finally, the “O” element of the PICO framework refers to the outcome, which defines the specific outcome or result you want to measure. In the case of a systematic review focusing on adult patients diagnosed with diabetes, interventions derived from self-determination theory, and usual treatment as the comparison, the outcome can include self-management. In other words, you want to determine the extent to which the intervention improves self-management among adult patients diagnosed with diabetes.
In systematic reviews and meta-analyses, the PICO framework is commonly used to frame a research question. To do so, you must start by defining the PICO elements. In most cases, the population of interest is known by a clinician or researcher. The intervention may be known or unknown. The comparison is also usually known, in most cases determined as “usual care” in various healthcare settings. Finally, in most cases, the outcome(s) is unknown, but it can also be pre-defined.
What I mean in this case is that, sometimes the researcher or clinician may be interested in identifying interventions (unknown) that bring about a certain outcome or results in a given target population. Since the intervention is unknown, the researcher can formulate the research question to imply that they are investigating interventions that bring about a certain effect. For example, “In adults diagnosed with diabetes (P), which interventions (I), compared to usual care (C), can improve self-management? (O)” In such a research question, the researcher or clinician knows the population, the comparison, and the outcome, but does not know the interventions, which will be the focus on their systematic review.
However, in most cases, the researcher knows the population, intervention, and comparison, but does not know the outcomes. For instance, “In adults diagnosed with diabetes (P), compared to usual care (C), what is the effectiveness of self-determination-based interventions (I) in improving self-management?” In this case, the researcher does not know whether the identified interventions improves self-management or not. It is important noting that any element of the PICO framework can be unknown.
Apart from framing a research question, the PICO framework can also be used in formulating eligibility criteria for systematic reviews. Take the example of a systematic review focusing on the effectiveness of self-determination theory-based interventions for improving self-management in adults diagnosed with diabetes. The eligibility criteria derived from the PICO framework can be as follows:
The four elements above are usually combined with study design, year of publication, and article language to formulate a complete eligibility criteria in PICO framework systematic reviews. The PICO framework guides the formulation of an eligibility criteria that can be used to select empirical studies that can answer a specific research question for clinical practice decision-making.
Finally, the PICO framework can be used in developing a literature search strategy. However, its use for this purpose is highly contentious. Some argue that when developing a search strategy, the outcomes should not be captured because they can lower the retrieval potential of that search strategy. Instead, the keywords used should only focus on the population and intervention elements. The outcomes will be determined when screening the articles for eligibility. Because of such disagreements among scholars, we did not include the development of a literature search strategy as one of the functions of a PICO framework in systematic reviews. Even so, we heavily recommend experimenting first. For example, you can harvest keywords relevant to each of the PICO elements. In the first search round, include keywords for population and intervention elements only. In the second round, introduce keywords from other PICO elements.
There are different types of systematic reviews depending on the type of research question being answered. Some research question types are suitable for other frameworks like SPIDER and CIMO. Other research questions are strictly suitable for a PICO framework. Therefore, before choosing PICO as your preferred framework, it is important to begin by determining whether the type of your research question is suitable. The following types of research questions are suitable for a PICO framework systematic review:
Once you have identified the suitability of PICO for your research question, the next step is to formulate the research question accordingly. The table below provides a detailed guidance on how to frame each question type based on the PICO framework:
PICO framework systematic reviews are those whose research questions and eligibility criteria are derived from the PICO framework. The PICO framework is one of the most common frameworks used in systematic reviews because it ensures research questions and eligibility criteria are not too specific or too broad.
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Systematic and systematic-like review toolkit.
Tip: Look for these icons for guidance on which technique is required
Email your Librarians
The first stage in a review is formulating the research question. The research question accurately and succinctly sums up the review's line of inquiry. This page outlines approaches to developing a research question that can be used as the basis for a review.
It can be useful to use a framework to aid in the development of a research question. Frameworks can help you identify searchable parts of a question and focus your search on relevant results
A technique often used in research for formulating a clinical research question is the PICO model. Slightly different versions of this concept are used to search for quantitative and qualitative reviews.
The PICO/ PECO framework is an adaptable approach to help you focus your research question and guide you in developing search terms. The framework prompts you to consider your question in terms of these four elements:
P : P atient/ P opulation/ P roblem
I/E : I ntervention/ I ndicator/ E xposure/ E vent
C : C omparison/ C ontrol
O : O utcome
For more detail, there are also the PICOT and PICOS additions:
PICO T - adds T ime
PICO S - adds S tudy design
Consider this scenario:
Current guidelines indicate that nicotine replacement therapies (NRTs) should not be used as an intervention in young smokers. Counselling is generally the recommended best practice for young smokers, however youth who are at high risk for smoking often live in regional or remote communities with limited access to counselling services. You have been funded to review the evidence for the effectiveness of NRTs for smoking cessation in Australian youths to update the guidelines.
The research question stemming from this scenario could be phrased in this way:
In (P) adolescent smokers , how does (I) nicotine replacement therapy compared with (C) counselling affect (O) smoking cessation rates ?
PICO element | Definition | Scenario |
---|---|---|
P (patient/population/problem) | Describe your patient, population, or problem | adolescent smokers |
I (intervention/indicator | Describe your intervention or indicator | Nicotine Replacement Therapy (NRT) |
C (comparison/control) | What is your comparison or control? | counselling |
O (outcome) | What outcome are you looking for? | smoking cessation / risk of continued nicotine dependency |
PICO is one of the most frequently used frameworks, but there are several other frameworks available to use, depending on your question.
Try PIC or SPIDER :
Cooke, A., Smith, D., & Booth, A. (2012). Beyond PICO: the SPIDER tool for qualitative evidence synthesis . Qualitative health research, 22(10), 1435-1443.
Moola, Sandeep; Munn, Zachary; Sears, Kim; Sfetcu, Ralucac; Currie, Marian; Lisy, Karolina; Tufanaru, Catalin; Qureshi, Rubab; Mattis, Patrick; Mu, Peifanf. Conducting systematic reviews of association (etiology) , International Journal of Evidence-Based Healthcare: September 2015 - Volume 13 - Issue 3 - p 163-169.
Try SPICE :
Booth, A. (2006), " Clear and present questions: formulating questions for evidence based practice ", Library Hi Tech, Vol. 24 No. 3, pp. 355-368. https://doi-org.ezproxy-b.deakin.edu.au/10.1108/07378830610692127
Try ECLIPSE :
Wildridge, V., & Bell, L. (2002). How CLIP became ECLIPSE: a mnemonic to assist in searching for health policy/management information . Health Information & Libraries Journal, 19(2), 113-115.
Try CoCoPop :
Munn, Z., Moola, S., Lisy, K., Riitano, D., & Tufanaru, C. (2015). Methodological guidance for systematic reviews of observational epidemiological studies reporting prevalence and cumulative incidence data . International journal of evidence-based healthcare, 13(3), 147-153.
Try PICOC :
Petticrew, M., & Roberts, H. (2006). Systematic reviews in the social sciences: a practical guide . Blackwell Pub.
JBI recommends the PCC (Population (or Participants), Concept, and Context) search framework to develop the research question of a scoping review. In some instances, just the concept and context are used in the search.
The University of Notre Dame Australia provides information on some different frameworks available to help structure the research question.
Booth A, Noyes J, Flemming K, et al, Formulating questions to explore complex interventions within qualitative evidence synthesis . BMJ Global Health 2019;4:e001107. This paper explores the importance of focused, relevant questions in qualitative evidence syntheses to address complexity and context in interventions.
Kim, K. W., Lee, J., Choi, S. H., Huh, J., & Park, S. H. (2015). Systematic review and meta-analysis of studies evaluating diagnostic test accuracy: a practical review for clinical researchers-part I. General guidance and tips . Korean journal of radiology, 16(6), 1175-1187. As the use of systematic reviews and meta-analyses is increasing in the field of diagnostic test accuracy (DTA), this first of a two-part article provides a practical guide on how to conduct, report, and critically appraise studies of DTA.
Methley, A. M., Campbell, S., Chew-Graham, C., McNally, R., & Cheraghi-Sohi, S. (2014). PICO, PICOS and SPIDER: A comparison study of specificity and sensitivity in three search tools for qualitative systematic reviews . BMC Health Services Research, 14(1), 579. In this article the ‘SPIDER’ search framework, developed for more effective searching of qualitative research, was evaluated against PICO and PICOD.
Munn, Z., Stern, C., Aromataris, E., Lockwood, C., & Jordan, Z. (2018). What kind of systematic review should I conduct? A proposed typology and guidance for systematic reviewers in the medical and health sciences . BMC medical research methodology, 18(1), 5. https://doi.org/10.1186/s12874-017-0468-4 This article aligns review types to question development frameworks.
Before you start searching, find out whether any systematic reviews have been conducted recently on your topic. This is because similar systematic reviews could help with identifying your search terms, and information on your topic. It is also helpful to know if there is already a systematic review on your topic as it may mean you need to change your question.
Cochrane Library and Joanna Briggs Institute publish systematic reviews. You can also search for the term "systematic review" in any of the subject databases. You can also search PROSPERO , an international register of systematic reviews, to see if there are any related reviews underway but not yet published; there are additional review registers detailed below.
Watch this video to find out how to search for published systematic reviews
It is recommended that authors consult relevant guidelines and create a protocol for their review.
Protocols provide a clear plan for how the review will be conducted, including what will and will not be included in the final review. Protocols are widely recommended for any systematic review and are increasingly a requirement for publication of a completed systematic review.
Guidelines provide specific information on how to perform a review in your field of study. A completed review may be evaluated against the relevant guidelines by peer reviewers or readers, so it makes sense to follow the guidelines as best you can.
Click the headings below to learn more about the importance of protocols and guidelines.
Your protocol (or plan for conducting your review) should include the rationale, objectives, hypothesis, and planned methods used in searching, screening and analysing identified studies used in the review. The rationale should clearly state what will be included and excluded from the review. The aim is to minimise any bias by having pre-defined eligibility criteria.
Base the protocol on the relevant guidelines for the review that you are conducting. PRISMA-P was developed for reporting and development of protocols for systematic reviews. Their Explanation and Elaboration paper includes examples of what to write in your protocol. York's CRD has also created a document on how to submit a protocol to PROSPERO .
There are several registers of protocols, often associated with the organisation publishing the review. Cochrane and Joanna Briggs Institute both have their own protocol registries, and PROSPERO is a wide-reaching registry covering protocols for Cochrane, non-Cochrane and non-JBI reviews on a range of health, social care, education, justice, and international development topics.
Before beginning your protocol, search within protocol registries such as those listed above, or Open Science Framework or Research Registry , or journals such as Systematic Reviews and BMJ Open . This is a useful step to see if a protocol has already been submitted on your review topic and to find examples of protocols in similar areas of research.
While a protocol will contain details of the intended search strategy, a protocol should be registered before the search strategy is finalised and run, so that you can show that your intention for the review has remained true and to limit duplication of in progress reviews.
A protocol should typically address points that define the kind of studies to be included and the kind of data required to ensure the systematic review is focused on the appropriate studies for the topic. Some points to think about are:
PLoS Medicine Editors. (2011). Best practice in systematic reviews: the importance of protocols and registration . PLoS medicine, 8(2), e1001009.
The Cochrane handbook of systematic reviews of interventions is a world-renowned resource for information on designing systematic reviews of intervention.
Many other guidelines have been developed from these extensive guidelines.
General systematic reviews
Meta-analyses
Surgical systematic reviews
Nursing/Allied Health systematic reviews
Joanna Briggs Institute Manual for Evidence Synthesis a comprehensive guide to conducting JBI systematic and similar reviews
Nutrition systematic reviews
Occupational therapy
Education/Law/ Sociology systematic reviews
Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy
COSMIN Guideline for Systematic Reviews of Outcome Measurement Instruments – This was developed for patient reported outcomes (PROMs) but has since been adapted for use with other types of outcome measurements in systematic reviews.
Prinsen, C.A.C., Mokkink, L.B., Bouter, L.M. et al. COSMIN guideline for systematic reviews of patient-reported outcome measures . Qual Life Res 27, 1147–1157 (2018). https://doi.org/10.1007/s11136-018-1798-3
HuGENet™ Handbook of systematic reviews – particularly useful for describing population-based data and human genetic variants.
AHRQ: Methods Guide for Effectiveness and Comparative Effectiveness Reviews - from the US Department of Health and Human Services, guidelines on conducting systematic reviews of existing research on the effectiveness, comparative effectiveness, and harms of different health care interventions.
Mariano, D. C., Leite, C., Santos, L. H., Rocha, R. E., & de Melo-Minardi, R. C. (2017). A guide to performing systematic literature reviews in bioinformatics . arXiv preprint arXiv:1707.05813.
Integrative reviews may incorporate experimental and non-experimental data, as well as theoretical information. They differ from systematic reviews in the diversity of the study methodologies included.
Guidelines:
Rapid reviews differ from systematic reviews in the shorter timeframe taken and reduced comprehensiveness of the search.
Cochrane has a methods group to inform the conduct of rapid reviews with a bibliography of relevant publications .
A modified approach to systematic review guidelines can be used for rapid reviews, but guidelines are beginning to appear:
Crawford C, Boyd C, Jain S, Khorsan R and Jonas W (2015), Rapid Evidence Assessment of the Literature (REAL©): streamlining the systematic review process and creating utility for evidence-based health care . BMC Res Notes 8:631 DOI 10.1186/s13104-015-1604-z
Philip Moons, Eva Goossens, David R. Thompson, Rapid reviews: the pros and cons of an accelerated review process , European Journal of Cardiovascular Nursing, Volume 20, Issue 5, June 2021, Pages 515–519, https://doi.org/10.1093/eurjcn/zvab041
Rapid Review Guidebook: Steps for conducting a rapid review National Collaborating Centre for Methods and Tools (McMaster University and Public Health Agency Canada) 2017
Tricco AC, Langlois EV, Straus SE, editors (2017) Rapid reviews to strengthen health policy and systems: a practical guide (World Health Organization). This guide is particularly aimed towards developing rapid reviews to inform health policy.
Scoping reviews can be used to map an area, or to determine the need for a subsequent systematic review. Scoping reviews tend to have a broader focus than many other types of reviews, however, still require a focused question.
Scoping reviews: what they are and how you can do them - Series of Cochrane Training videos presented by Dr. Andrea C. Tricco and Kafayat Oboirien
Martin, G. P., Jenkins, D. A., Bull, L., Sisk, R., Lin, L., Hulme, W., ... & Group, P. H. A. (2020). Toward a framework for the design, implementation, and reporting of methodology scoping reviews . Journal of Clinical Epidemiology, 127, 191-197.
Khalil, H., McInerney, P., Pollock, D., Alexander, L., Munn, Z., Tricco, A. C., ... & Peters, M. D. (2021). Practical guide to undertaking scoping reviews for pharmacy clinicians, researchers and policymakers . Journal of clinical pharmacy and therapeutics.
Colquhoun, H (2016) Current best practices for the conduct of scoping reviews (presentation)
Arksey H & O'Malley L (2005) Scoping studies: towards a methodological framework , International Journal of Social Research Methodology, 8:1, 19-32, DOI: 10.1080/1364557032000119616
Noyes, J., Booth, A., Cargo, M., Flemming, K., Garside, R., Hannes, K., ... & Thomas, J. (2018). Cochrane Qualitative and Implementation Methods Group guidance series—paper 1: introduction . Journal of clinical epidemiology, 97, 35-38.
Harris, J. L., Booth, A., Cargo, M., Hannes, K., Harden, A., Flemming, K., ... & Noyes, J. (2018). Cochrane Qualitative and Implementation Methods Group guidance series—paper 2: methods for question formulation, searching, and protocol development for qualitative evidence synthesis . Journal of clinical epidemiology, 97, 39-48.
Noyes, J., Booth, A., Flemming, K., Garside, R., Harden, A., Lewin, S., ... & Thomas, J. (2018). Cochrane Qualitative and Implementation Methods Group guidance series—paper 3: methods for assessing methodological limitations, data extraction and synthesis, and confidence in synthesized qualitative findings . Journal of clinical epidemiology, 97, 49-58.
Cargo, M., Harris, J., Pantoja, T., Booth, A., Harden, A., Hannes, K., ... & Noyes, J. (2018). Cochrane Qualitative and Implementation Methods Group guidance series—paper 4: methods for assessing evidence on intervention implementation . Journal of clinical epidemiology, 97, 59-69.
Harden, A., Thomas, J., Cargo, M., Harris, J., Pantoja, T., Flemming, K., ... & Noyes, J. (2018). Cochrane Qualitative and Implementation Methods Group guidance series—paper 5: methods for integrating qualitative and implementation evidence within intervention effectiveness reviews . Journal of clinical epidemiology, 97, 70-78.
Flemming, K., Booth, A., Hannes, K., Cargo, M., & Noyes, J. (2018). Cochrane Qualitative and Implementation Methods Group guidance series—Paper 6: Reporting guidelines for qualitative, implementation, and process evaluation evidence syntheses . Journal of Clinical Epidemiology, 97, 79-85.
Walsh, D. and Downe, S. (2005), Meta-synthesis method for qualitative research: a literature review . Journal of Advanced Nursing, 50: 204–211. doi:10.1111/j.1365-2648.2005.03380.x
The RAMESES Projects - Includes information on publication, quality, and reporting standards, as well as training materials for realist reviews, meta-narrative reviews, and realist evaluation.
Rycroft-Malone, J., McCormack, B., Hutchinson, A. M., DeCorby, K., Bucknall, T. K., Kent, B., ... & Wilson, V. (2012). Realist synthesis: illustrating the method for implementation research . Implementation Science, 7(1), 1-10.
Wong, G., Westhorp, G., Manzano, A. et al. RAMESES II reporting standards for realist evaluations. BMC Med 14, 96 (2016). https://doi.org/10.1186/s12916-016-0643-1
Wong, G., Greenhalgh, T., Westhorp, G., Buckingham, J., & Pawson, R. (2013). RAMESES publication standards: realist syntheses. BMC medicine, 11, 21. https://doi.org/10.1186/1741-7015-11-21
Wong, G., Greenhalgh, T., Westhorp, G., Buckingham, J., & Pawson, R. (2013). RAMESES publication standards: realist syntheses. BMC medicine, 11(1), 1-14. https://doi.org/10.1186/1741-7015-11-21
Social sciences
Uttley, L., Montgomery, P. The influence of the team in conducting a systematic review . Syst Rev 6, 149 (2017). https://doi.org/10.1186/s13643-017-0548-x
According to the Centre for Evidence Based Medicine (CEBM), well-formed clinical questions are essential in practicing EBM. "To benefit patients and clinicians, such questions need to be both directly relevant to patients' problems and phrased in ways that direct your search to relevant and precise answers." - CEBM, University of Toronto, Asking Focused Questions
The PICO model is a tool that can help you formulate a good clinical question. Sometimes it's referred to as PICO-T, containing an optional 5th factor.
P - Patient, Population, or Problem | What are the most important characteristics of the patient? How would you describe a group of patients similar to yours? |
I - Intervention, Exposure, Prognostic Factor | What main intervention, prognostic factor, or exposure are you considering? What do you want to do for the patient (prescribe a drug, order a test, etc.)? |
C - Comparison | What is the main alternative to compare with the intervention? |
O - Outcome | What do you hope to accomplish, measure, improve, or affect? |
T - Time Factor, Type of Study (optional) | How would you categorize this question? What would be the best study design to answer this question? |
This page was adapted from (PA/MPH) PICO by George Washington University, Himmelfarb Health Sciences Library.
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Home | Blog | How To | How to formulate the review question using PICO. 5 steps to get you started.
You’ve decided to go ahead. You have identified a gap in the evidence and you know that conducting a systematic review, with its explicit methods and replicable search, is the best way to fill it – great choice 🙌.
The review will produce useful information to enable informed decision-making and to improve patient care. Your review team’s first job is to capture exactly what you need to know in a well-formulated review question.
At this stage there is a lot to plan. You might be recruiting people to your review team, thinking about the time-frame for completion and considering what software to use. It’s tempting to get straight on to the search for studies 🏃.
Take it slowly: it’s vital to get the review question right. A clear and precise question will ensure that you gather the appropriate data to answer your question. Time invested up-front to consider every aspect of the question will pay off once the review is underway. The review question will shape all the subsequent stages in the review, particularly setting the criteria for including and excluding studies, the search strategy, and the way you choose to present the results. So it’s worth taking the time to get this right!
Let’s take a look at five key steps in formulating the question for a standard systematic review of interventions. It’s a process that requires careful thought from a range of stakeholders and meticulous planning. But what if, once you have started the review, you find that you need to tweak the question anyway? Don’t worry, we’ll cover that too ✅.
Who will use this review? What do they want to know? How do they measure effectiveness? Good review teams partner with the people who will use the evidence and make sure that their research plan (or protocol) asks a question that is relevant and important for patients.
How much do you need to know about the topic area at this stage? Ideally, enough to come up with a relevant, useful question but not so much that your knowledge influences the way in which you phrase it. Why? Because setting a review question when you are already familiar with the data can introduce bias by allowing you to direct the question in favour of achieving a particular result. In practice, the review team is very likely to have some knowledge of relevant studies and some preconceived ideas about how the treatments work. That’s fine – and it’s useful – but it’s also good practice to recognise the influence this knowledge and these ideas might have on the choice of question. Issues of bias will come up again as we work through the rest of these steps.
If not enough is known about the subject area to ask a useful question, you might undertake a scoping review . This is a separate exercise from a systematic review and is sometimes used by researchers to map the literature and highlight gaps in the evidence before they start work on a systematic review.
Faced with a heady mixture of concepts, ideas, aims and outcomes, researchers in every field have come up with question frameworks (and some great backronyms ) to help them. Question frameworks impose order on a complex thought process by breaking down a question into its component parts. A commonly used framework in clinical medicine is PICO:
👦 P opulation (or patients) refers to the characteristics of the people that you want to study. For example, the review might look at children with nocturnal enuresis.
💊 I ntervention is the treatment you are investigating. For example, the review might look at the effectiveness of enuresis alarms.
💊 C omparison, if you decide to use one, is the treatment you want to compare the intervention with. For example, the review might look at the effectiveness of enuresis alarms versus the effectiveness of drug therapy.
📏 O utcomes are the measures used to assess the effectiveness of the treatment. It’s particularly important to select outcomes that matter to the end users of the review. In this example, a useful outcome might be bedwetting. (Helpfully, some clinical areas use standardised sets of outcomes in their clinical trials to facilitate the comparison of data between studies 👏.)
But back to bedwetting. In our example, a PICO review question would look something like this:
“In children with nocturnal enuresis (population), how effective are alarms (intervention) versus drug treatments (comparison) for the prevention of bedwetting (outcome)?”
PICO is suitable for reviews of interventions. If you plan to review prognostic or qualitative data, or diagnostic test accuracy, PICO is unlikely to be a suitable framework for your question. In Covidence you can save your PICO for easy reference throughout the screening, extraction and quality assessment phases of your review.
The scope of a review question requires careful thought. To answer the example PICO question above, the review would compare one treatment (alarms) with another (drug therapy). A broader question might consider all the available treatments for nocturnal enuresis in children. The broad scope of this question would still allow the review team to drill down and separate the data into groups of specific treatments later in the review process. And to minimise bias, the intended grouping of data would be pre-specified and justified in the protocol or research plan.
Broader systematic reviews are great because they summarise all the evidence on a given topic in one place. A potential disadvantage is that they can produce a large volume of data that is difficult to manage.
If the size of the review has started to escalate beyond your comfort zone, you might consider narrowing the scope. This can make the size of the review more manageable, both for the review team and for the reader. But it’s worth examining the motivations for narrowing the scope more closely. Suppose we wanted to define a smaller population in the example PICO question. Is there a good reason (other than to reduce the review team’s workload) to restrict the population to boys with nocturnal enuresis? Or to children under 10 years old? On the basis of what is already known, could the treatment effect be expected to differ by sex or age of the study participants? 🤔 Be prepared to explain your choices and to demonstrate that they are legitimate.
Some reviews with a narrow scope retrieve only a small number of studies. If this happens, there is a risk that the data collected from these studies might not be enough to produce a useful synthesis or to guide decision-making. It can be frustrating for review teams who have spent time defining the question, planning the methods, and conducting an extensive search to find that their question is unanswerable. This is another reason why it is useful for the review team to have prior knowledge of the subject area and some familiarity with the existing evidence. The Cochrane Handbook contains some useful contingencies for dealing with sparse data .
Covidence can help review teams to save time whatever the scope and size of the review. In Covidence, data can be grouped to the review team’s exact specification for seamless export into data analysis software. The intuitive workflow makes collaboration simple so if one reviewer spots a problem, they can alert the rest of the team quickly and easily.
Systematic reviews follow explicit, pre-specified methods. So it’s no surprise to learn that the review question needs to be considered carefully and explained in detail before the review gets underway. But what about the unknown unknowns – those issues that the review teams will have to deal with later in the process but that they cannot foresee at the outset, no matter how much time they spend on due diligence?
Clearly, reviews need the agility to control for issues that the project plan did not anticipate – strict adherence to the pre-specified process when a good reason to deviate has come to light would carry its own risks for the quality of the review. So if an initial scan of, for example, the search results indicates that it would be sensible to modify the question, this can be done. The research plan might make explicit the process for dealing with these types of changes. It might also contain plans for sensitivity analysis , to examine whether these choices have any effect on the findings of the review. As mentioned above with regard to scope, it might be difficult to defend a data-driven change to the question. And as before, the issue is the risk of bias and the danger of producing a spurious result.
(Figure 4. Image from Eshun‐Wilson I, Siegfried N, Akena DH, Stein DJ, Obuku EA, Joska JA. Antidepressants for depression in adults with HIV infection. Cochrane Database of Systematic Reviews 2018, Issue 1. Art. No.: CD008525. DOI: 10.1002/14651858.CD008525.pub3. Accessed 27 May 2021.)
This blog post is part of the Covidence series on how to write a systematic review.
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Clarifying the review question leads to specifying what type of studies can best address that question and setting out criteria for including such studies in the review. This is often called inclusion criteria or eligibility criteria. The criteria could relate to the review topic, the research methods of the studies, specific populations, settings, date limits, geographical areas, types of interventions, or something else.
Systematic reviews address clear and answerable research questions, rather than a general topic or problem of interest. They also have clear criteria about the studies that are being used to address the research questions. This is often called inclusion criteria or eligibility criteria.
Six examples of types of question are listed below, and the examples show different questions that a review might address based on the topic of influenza vaccination. Structuring questions in this way aids thinking about the different types of research that could address each type of question. Mneumonics can help in thinking about criteria that research must fulfil to address the question. The criteria could relate to the context, research methods of the studies, specific populations, settings, date limits, geographical areas, types of interventions, or something else.
Examples in practice : Seasonal influenza vaccination of health care workers: evidence synthesis / Loreno et al. 2017
Research question: What are the views and experiences of UK healthcare workers regarding vaccination for seasonal influenza?
It is important to consider the reasons that the research question is being asked. Any research question has ideological and theoretical assumptions around the meanings and processes it is focused on. A systematic review should either specify definitions and boundaries around these elements at the outset, or be clear about which elements are undefined.
For example if we are interested in the topic of homework, there are likely to be pre-conceived ideas about what is meant by 'homework'. If we want to know the impact of homework on educational attainment, we need to set boundaries on the age range of children, or how educational attainment is measured. There may also be a particular setting or contexts: type of school, country, gender, the timeframe of the literature, or the study designs of the research.
Research question: What is the impact of homework on children's educational attainment?
Some mnemonics that sometimes help to formulate research questions, set the boundaries of question and inform a search strategy.
Intervention effects
PICO Population – Intervention– Outcome– Comparison
Variations: add T on for time, or ‘C’ for context, or S’ for study type,
Policy and management issues
ECLIPSE : Expectation – Client group – Location – Impact ‐ Professionals involved – Service
Expectation encourages reflection on what the information is needed for i.e. improvement, innovation or information. Impact looks at what you would like to achieve e.g. improve team communication .
Analysis tool for management and organisational strategy
PESTLE: Political – Economic – Social – Technological – Environmental ‐ Legal
An analysis tool that can be used by organizations for identifying external factors which may influence their strategic development, marketing strategies, new technologies or organisational change.
Service evaluations with qualitative study designs
SPICE: Setting (context) – Perspective– Intervention – Comparison – Evaluation
Perspective relates to users or potential users. Evaluation is how you plan to measure the success of the intervention.
Read more about some of the frameworks for constructing review questions:
Inclusion/exclusion criteria, has your review already been done, where to find other reviews or syntheses, references on question formulation frameworks.
Formulating a well-constructed research question is essential for a successful review. You should have a draft research question before you choose the type of knowledge synthesis that you will conduct, as the type of answers you are looking for will help guide your choice of knowledge synthesis.
A systematic review question | A scoping review question |
---|---|
Typically a focused research question with narrow parameters, and usually fits into the PICO question format | Often a broad question that looks at answering larger, more complex, exploratory research questions and often does not fit into the PICO question format |
Example: "In people with multiple sclerosis, what is the extent to which a walking intervention, compared to no intervention, improves self-report fatigue?" | Example: "What rehabilitation interventions are used to reduce fatigue in adults with multiple sclerosis?" |
Developing a good research question is not a straightforward process and requires engaging with the literature as you refine and rework your idea.
It is important to think about which studies will be included in your review when you are writing your research question. The Cochrane Handbook chapter (linked below) offers guidance on this aspect.
McKenzie, J. E., Brennan, S. E., Ryan, R. E., Thomson, H. J., Johnston, R. V, & Thomas, J. (2021). Chapter 3: Defining the criteria for including studies and how they will be grouped for the synthesis. Retrieved from https://training.cochrane.org/handbook/current/chapter-03
Once you have a reasonably well defined research question, it is important to make sure your project has not already been recently and successfully undertaken. This means it is important to find out if there are other knowledge syntheses that have been published or that are in the process of being published on your topic.
If you are submitting your review or study for funding, for example, you may want to make a good case that your review or study is needed and not duplicating work that has already been successfully and recently completed—or that is in the process of being completed. It is also important to note that what is considered “recent” will depend on your discipline and the topic.
In the context of conducting a review, even if you do find one on your topic, it may be sufficiently out of date or you may find other defendable reasons to undertake a new or updated one. In addition, looking at other knowledge syntheses published around your topic may help you refocus your question or redirect your research toward other gaps in the literature.
The Cochrane Library (including systematic reviews of interventions, diagnostic studies, prognostic studies, and more) is an excellent place to start, even if Cochrane reviews are also indexed in MEDLINE/PubMed.
By default, the Cochrane Library will display “ Cochrane Reviews ” (Cochrane Database of Systematic Reviews, aka CDSR). You can ignore the results which show up in the Trials tab when looking for systematic reviews: They are records of controlled trials.
The example shows the number of Cochrane Reviews with hiv AND circumcision in the title, abstract, or keywords.
Alternatively, you can use a search hedge/filter; for example, the filter used by BMJ Best Practice to find systematic reviews in Embase (can be copied and pasted into the Embase search box then combined with the concepts of your research question):
(exp review/ or (literature adj3 review$).ti,ab. or exp meta analysis/ or exp "Systematic Review"/) and ((medline or medlars or embase or pubmed or cinahl or amed or psychlit or psyclit or psychinfo or psycinfo or scisearch or cochrane).ti,ab. or RETRACTED ARTICLE/) or (systematic$ adj2 (review$ or overview)).ti,ab. or (meta?anal$ or meta anal$ or meta-anal$ or metaanal$ or metanal$).ti,ab.
Alternative interface to PubMed: You can also search MEDLINE on the Ovid platform, which we recommend for systematic searching. Perform a sufficiently developed search strategy (be as broad in your search as is reasonably possible) and then, from Additional Limits , select the publication type Systematic Reviews, or select the subject subset Systematic Reviews Pre 2019 for more sensitive/less precise results.
The subject subset for Systematic Reviews is based on the filter version used in PubMed .
Perform a sufficiently developed search strategy (be as broad in your search as is reasonably possible) and then, from Additional Limits , select, under Methodology, 0830 Systematic Review
See Systematic Reviews Search Strategy Applied in PubMed for details.
Munn Z, Stern C, Aromataris E, Lockwood C, Jordan Z. What kind of systematic review should I conduct? A proposed typology and guidance for systematic reviewers in the medical and health sciences. BMC Med Res Methodol. 2018;18(1):5. doi: 10.1186/s12874-017-0468-4
Scoping reviews: Developing the title and question . In: Aromataris E, Munn Z (Editors) . JBI Manual for Evidence Synthesis. JBI; 2020. https://doi.org/10.46658/JBIMES-20-01
Due to a large influx of requests, there may be an extended wait time for librarian support on knowledge syntheses.
Find a librarian in your subject area to help you with your knowledge synthesis project.
Or contact the librarians at the Schulich Library of Physical Sciences, Life Sciences, and Engineering s [email protected]
Online training resources.
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Writing your question statement.
This YouTube presentation by Jeffery Hill covers structuring a focussed clinical question using the PICO framework:
The first step in performing a Systematic Review is to formulate the research question. Without a well-focused question, it can be very difficult and time consuming to identify appropriate resources and search for relevant evidence. Practitioners of Evidence-Based Practice (EBP) often use a specialised framework, called PICO , to form the question and facilitate the literature search. 1 PICO stands for:
For Systematic Reviews an additional item, T is sometimes added to the framework. The T can stand for :
When forming your question using PICO , keep the following points in mind:
When forming your question using the PICO framework it is useful to think about what type of question it is you are asking, (therapy, prevention, diagnosis, prognosis, etiology). The table below illustrates ways in which P roblems, I nterventions, C omparisons and O utcomes vary according to the t ype (domain) of your question. 2
Once you have clearly identified the main elements of your question using the PICO framework, it is easy to write your question statement. The following table provides some examples.
1. Schardt, C., Adams, M. B., Owens, T., Keitz, S., & Fontelo, P. (2007). Utilization of the PICO framework to improve searching PubMed for clinical questions. BMC Medical Informatics and Decision Making , 7, 16. doi: http://dx.doi.org/10.1186/1472-6947-7-1
2. Fineout-Overholt, E., & Johnston, L. (2005). Teaching EBP: asking searchable, answerable clinical questions. Worldviews On Evidence-Based Nursing , 2, 157-160.
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Abigail m methley.
University of Manchester, Centre for Primary Care, Williamson Building, Oxford Road, Manchester, M13 9PL UK
NIHR Greater Manchester Primary Care Patient Safety Translational Research Centre, Institute of Population Health, The University of Manchester, Manchester, M13 9WL UK
Institute of Primary Care and Health Sciences, Keele University, Keele, UK
Central Manchester Hospitals Site, Manchester Mental Health and Social Care Trust, Research and Innovation 3rd Floor, Rawnsley Building, Hathersage Road, Manchester, M13 9WL UK
Qualitative systematic reviews are increasing in popularity in evidence based health care. Difficulties have been reported in conducting literature searches of qualitative research using the PICO search tool. An alternative search tool, entitled SPIDER, was recently developed for more effective searching of qualitative research, but remained untested beyond its development team.
In this article we tested the ‘SPIDER’ search tool in a systematic narrative review of qualitative literature investigating the health care experiences of people with Multiple Sclerosis. Identical search terms were combined into the PICO or SPIDER search tool and compared across Ovid MEDLINE, Ovid EMBASE and EBSCO CINAHL Plus databases. In addition, we added to this method by comparing initial SPIDER and PICO tools to a modified version of PICO with added qualitative search terms (PICOS).
Results showed a greater number of hits from the PICO searches, in comparison to the SPIDER searches, with greater sensitivity. SPIDER searches showed greatest specificity for every database. The modified PICO demonstrated equal or higher sensitivity than SPIDER searches, and equal or lower specificity than SPIDER searches. The modified PICO demonstrated lower sensitivity and greater specificity than PICO searches.
The recommendations for practice are therefore to use the PICO tool for a fully comprehensive search but the PICOS tool where time and resources are limited. Based on these limited findings the SPIDER tool would not be recommended due to the risk of not identifying relevant papers, but has potential due to its greater specificity.
Systematic reviews are a crucial method, underpinning evidence based practice and informing health care decisions [ 1 , 2 ]. Traditionally systematic reviews are completed using an objective and primarily quantitative approach [ 3 ] whereby a comprehensive search is conducted, attempting to identify all relevant articles which are then integrated and assimilated through statistical analysis. The comprehensiveness of the search process has been viewed as a key factor in preventing bias and providing a true representation of available research [ 4 ]. Current research investigating the process of quantitative systematic reviews therefore focuses on methods for ensuring the most comprehensive and bias free searches possible [ 5 ]. Because of the time and resources required to complete a systematic and comprehensive search, efforts have been made to investigate the sensitivity of searches, and thus lessen the amount of time spent reviewing irrelevant articles with no benefit [ 6 ].
However, conducting comprehensive searches also forms the bedrock of qualitative or narrative reviews, now commonly referred to as qualitative evidence syntheses [ 7 ]. Qualitative evidence syntheses are now acknowledged as a necessary and valuable type of information to answer health services research questions [ 8 ]. However, difficulties in completing a sensitive yet comprehensive search of qualitative literature have been previously noted [ 9 - 11 ] including: poor indexing and use of key words of qualitative studies, the common use of titles that lack the keywords describing the article, and unstructured abstracts.
When devising a search strategy, a search tool is used as an organising framework to list terms by the main concepts in the search question, especially in teams where it is not possible to have an experienced information specialist as a member of the review team. The PICO tool focuses on the Population, Intervention, Comparison and Outcomes of a (usually quantitative) article. It is commonly used to identify components of clinical evidence for systematic reviews in evidence based medicine and is endorsed by the Cochrane Collaboration [ 2 ]. Due to its target literature base several of these search terms such as “control group” and “intervention” are not relevant to qualitative research which traditionally does not utilise control groups or interventions, and therefore may not appropriately locate qualitative research. However, these terms may become more relevant in the future as more trials and interventions incorporate qualitative research [ 12 ].
As the PICO tool does not currently accommodate terms relating to qualitative research or specific qualitative designs, it has often been modified in practice to “PICOS” where the “S” refers to the Study design [ 4 ], thus limiting the number of irrelevant articles.
Cooke et al. also addressed this issue of relevance by developing a new search tool entitled “SPIDER” (sample, phenomenon of interest, design, evaluation, research type), designed specifically to identify relevant qualitative and mixed-method studies [ 9 ]. The key features and differences of the SPIDER and PICO search tools are shown in Table 1 . The addition of the “design” and “research type” categories to the SPIDER tool was intended to further increase the ability of this tool to identify qualitative articles, whilst removing irrelevant PICO categories such as the “comparison” group [ 9 ].
Search categories and SPIDER and PICO headings
Multiple Sclerosis and patient/service user | opulation | opulation | ample |
Health care services | ntervention | ntervention | henomenon of nterest |
Named types of qualitative data collection and analysis | omparison | omparison | esign |
Experiences, perceptions | utcome | utcome | valuation |
Qualitative or qualitative method | not applicable | tudy type | esearch type |
Cooke et al. recommended that the SPIDER tool was tested further in qualitative literature searches [ 9 ]. Although it has been used previously in a scoping review to investigate gaps in an evidence base on community participation in rural health care [ 13 ], SPIDER has not yet been tested and evaluated in a qualitative systematic narrative review context. The authors of this article recently completed a systematic review of the qualitative research investigating experiences of health care services for people with Multiple Sclerosis [ 14 ]. On embarking on this review topic we faced many of the difficulties commonly discussed in identifying qualitative literature on a given topic, and identified SPIDER as a potential way of overcoming some of these difficulties. Therefore, the aim of this article was to test SPIDER by broadly replicating the work of Cooke et al. [ 9 ], specifically by comparing the two approaches: 1) the traditional PICO method of searching electronic databases with 2) the newly devised SPIDER tool, developed for qualitative and mixed-method research. In addition we wished to build and expand on the work of Cooke et al. [ 9 ] and so our third aim was to compare PICO and SPIDER to a modified PICO with qualitative study designs (PICOS, see Table 1 by investigating specificity and sensitivity across 3 major databases.
Studies eligible for inclusion were those that qualitatively investigated patients’ experiences, views, attitudes to and perceptions of health care services for Multiple Sclerosis. No date restriction was imposed on searches as this was an original review. Qualitative research, for this purpose, was defined by the Cochrane qualitative methods group [ 7 ] as using both a qualitative data collection method and qualitative analysis. Quantitative and mixed method studies were therefore excluded.
We define experience as “ Patients’ reports of how care was organised and delivered to meet their needs p.301” [ 15 ]. Patients’ reports could refer to either experience of health care services delivery and organisation overall or their experiences of care by specific health care personnel. We included studies that investigated adults (aged 18 years old and older) with a diagnosis of Multiple Sclerosis, who had experience of utilising health care services at any time point. There were no restrictions on subtype of Multiple Sclerosis, gender, ethnicity or frequency of use of health care. Health care in this sense referred to routine clinical care (either state funded or privately funded) not trial protocols or interventions. Excluded studies included studies that focussed on self-management and studies that investigated quality of life.
Because of the focus on Multiple Sclerosis, studies were excluded if they used a mixed sample of various conditions (e.g. studies reported a mixed sample of people with neurological conditions) or if they used a sample of mixed respondents (i.e. people with Multiple Sclerosis and their carers) where results of patients with Multiple Sclerosis could not be clearly separated. If an article had a section or subtheme on health care services but this was not the main research area of the article, then that article was included; however only data from the relevant subtheme were extracted and included in the findings. Additional exclusion criteria were articles that only described carer or health care professional experiences not patient experiences. Conference abstracts, editorials and commentaries were not included.
For this systematic search we developed a detailed search strategy in collaboration with a specialist librarian and information specialist. This search strategy was tailored to the three largest medical and nursing databases (Ovid MEDLINE, Ovid EMBASE, and EBSCO CINAHL Plus) as in Cooke et al.’s study [ 9 ] and search terms used a mixture of medical subject headings and keywords. To investigate the benefit of the SPIDER,PICO and PICOS tools we used identical search terms but combined them in different ways as shown in Tables 2 , ,3 3 and and4 4 below.
The search terms used in the SPIDER search
S | [MH Multiple Sclerosis OR TX multiple sclerosis] AND MH patients OR TX service user* or TX service-user* | [exp multiple sclerosis/OR multiple sclerosis.tw]AND [exp Patients/OR patient*.tw OR service user*.tw OR service-user*.tw OR exp consumer participation/OR consumer.tw] | [exp multiple sclerosis/OR multiple sclerosis.tw] AND [exp patient/patient$.tw OR service user$.tw OR service-user$ OR consumer$.tw] |
P and I | MH (health services needs and demands) OR TX health care OR TX health services OR TX care OR MH patient care OR MH health personnel OR MH health services administration OR MH health services OR MH health facilities OR MH mental health services OR MH therapeutics OR TX specialist care MM “Multiple Sclerosis Psychosocial Factors” OR MM “Multiple sclerosis diagnosis” OR MM “Multiple sclerosis drug therapy” | exp “health care facilities, manpower and services”/OR health care.tw OR health services.tw OR exp Health Services Administration/OR exp Therapeutics/OR exp Diagnosis/OR organisations.tw OR exp Health Occupations/OR consultation.tw OR referral.tw OR exp Health Personnel/OR Health Education/OR hospital*.tw OR consultant*.tw OR neurologist*.tw OR doctor* OR practice nurse*.tw OR specialist nurse* OR psychologist*.tw OR general practitioner*.tw OR exp “psychiatry and psychology (non mesh)”/OR exp/Dentistry/ OR exp investigative techniques/OR exp “health care economics and organisations”/ OR specialist care.tw OR mental health services.tw OR mental health care.tw OR secondary care.tw | exp health care/OR health care.tw OR exp health service/OR exp health care organisation/OR exp health care utilization/ OR exp “care and caring”/OR care.tw OR medical care.tw OR exp health care personnel/OR health service$.tw OR health care professional$.tw OR exp health care quality/OR exp terminal care/OR exp health care management/ OR exp medical procedures/OR exp health care facility/OR hospital$.tw OR welfare/or *human needs/or *social welfare OR exp medical ethics/ OR consultant$.tw OR neurologist$.tw OR doctor$.tw OR practice nurse$.tw OR specialist nurse$.tw OR psychologist$.tw OR general practitioner$.tw OR mental health care.tw OR mental health services.tw or psycholog$ services.tw OR specialist care.tw OR secondary care.tw OR primary care.tw OR primary health care.tw |
D | TX qualitative interview OR MH focus groups OR MH content analysis OR MH constant comparative method OR MH thematic analysis OR MH grounded theory OR MH ethnographic research OR MH phenomenological research OR MH semantic analysis OR TX interview* | exp interviews as Topic/OR exp Nursing Methodology Research/OR content analysis.tw OR constant comparative.tw OR grounded theory.tw OR ethography.tw OR interpretative phenomenological analysis.tw | exp interview/OR exp grounded theory/OR exp ethnography/OR interpretative phenomenological analysis.tw OR exp phenomenology/OR focus group$.tw OR exp content analysis/ OR exp thematic analysis/ OR exp constant comparative/ |
E | TX perception* OR MH patient satisfaction OR TX satisf* OR TX value* OR TX perceive* OR TX perspective* OR TX view* OR TX experience OR MH (health services needs and demand) OR TX opinion* OR MH consumer satisfaction OR TX belie* OR MM “Patient Attitudes” OR MM “Attitude to illness” | perceive*.tw OR perception*.tw OR exp Consumer Participation/OR *personal satisfaction/OR exp Consumer Satisfaction/OR satis*.tw OR exp Hospital-Patient Relations/OR exp Professional- Patient Relations/OR value*.tw OR perspective*.tw OR view*.tw OR experience*.tw OR need*.tw OR exp “Health Services Needs and Demand”/OR issue*.tw OR exp Attitude/OR belie*.tw OR opinion*.tw OR feel*.tw OR know*.tw OR understand*.tw | Perception$.tw OR exp satisfaction/OR satis$.tw OR value$.tw OR perceive$.tw OR exp psychological aspect/OR perspective$.tw OR view$.tw OR exp personal experience/OR experience$.tw OR exp health care need/OR need$.tw OR exp human needs/OR issue$.tw OR exp medical ethics/OR opinion$.tw OR exp attitude/OR exp health belief/OR attitude$.tw OR belie$.tw OR feel$.tw OR know$.tw OR understand$.tw |
R | AB qualitative OR MH qualitative studies | exp Qualitative Research/ OR qualitative.tw | qualitative.tw OR qualitative analysis.tw OR exp qualitative research/ |
a [S AND P of I] AND [(D or E) AND R].
Footnote: * is a truncation symbol to retrieve terms with a common root within CINHAL Plus and MEDLINE. $ is a truncation symbol to retrieve terms with a common root within EMBASE.
The search terms used in the PICO search
P | [MH Multiple Sclerosis OR TX multiple sclerosis] AND MH patients OR TX service user* or TX service-user* | [exp multiple sclerosis/OR multiple sclerosis.tw]AND [exp Patients/OR patient*.tw OR service user*.tw OR service-user*.tw OR exp consumer participation/ OR consumer.tw] | [exp multiple sclerosis/OR multiple sclerosis.tw] AND [exp patient/patient$.tw OR service user$.tw OR service-user$ OR consumer$.tw] |
I | MH (health services needs and demands) OR TX health care OR TX health services OR TX care OR MH patient care OR MH health personnel OR MH health services administration OR MH health services OR MH health facilities OR MH mental health services OR MH therapeutics OR TX specialist care MM “Multiple Sclerosis Psychosocial Factors”OR MM “Multiple sclerosis diagnosis” OR MM “Multiple sclerosis drug therapy” | exp “health care facilities, manpower and services”/OR health care.tw OR health services.tw OR exp Health Services Administration/OR exp Therapeutics/OR exp Diagnosis/OR organisations.tw OR exp Health Occupations/OR consultation.tw OR referral.tw OR exp Health Personnel/OR Health Education/OR hospital*.tw OR consultant*.tw OR neurologist*.tw OR doctor* OR practice nurse*.tw OR specialist nurse* OR psychologist*.tw OR general practitioner*.tw OR exp “psychiatry and psychology (non mesh)”/OR exp/Dentistry/OR exp investigative techniques/OR exp “health care economics and organisations”/ OR specialist care.tw OR mental health services.tw OR mental health care.tw OR secondary care.tw | exp health care/OR health care.tw OR exp health service/OR exp health care organisation/OR exp health care utilization/ OR exp “care and caring”/OR care.tw OR medical care.tw OR exp health care personnel/OR health service$.tw OR health care professional$.tw OR exp health care quality/OR exp terminal care/ OR exp health care management/ OR exp medical procedures/OR exp health care facility/OR hospital$.tw OR welfare/or *human needs/or *social welfare OR exp medical ethics/OR consultant$.tw OR neurologist$.tw OR doctor$.tw OR practice nurse$.tw OR specialist nurse$.tw OR psychologist$.tw OR general practitioner$.tw OR mental health care.tw OR mental health services.tw or psycholog$ services.tw OR specialist care.tw OR secondary care.tw OR primary care.tw OR primary health care.tw |
C | n/a | n/a | n/a |
O | TX perception* OR MH patient satisfaction OR TX satisf* OR TX value* OR TX perceive* OR TX perspective* OR TX view* OR TX experience OR MH (health services needs and demand) OR TX opinion* OR MH consumer satisfaction OR TX belie* OR MM “Patient Attitudes” OR MM “Attitude to illness” | perceive*.tw OR perception*.tw OR exp Consumer Participation/ OR *personal satisfaction/OR exp Consumer Satisfaction/ OR satis*.tw OR exp Hospital-Patient Relations/OR exp Professional- Patient Relations/ OR value*.tw OR perspective*.tw OR view*.tw OR experience*.tw OR need*.tw OR exp “Health Services Needs and Demand”/OR issue*.tw OR exp Attitude/OR belie*.tw OR opinion*.tw OR feel*.tw OR know*.tw OR understand*.tw | Perception$.tw OR exp satisfaction/OR satis$.tw OR value$.tw OR perceive$.tw OR exp psychological aspect/OR perspective$.tw OR view$.tw OR exp personal experience/OR experience$.tw OR exp health care need/OR need$.tw OR exp human needs/OR issue$.tw OR exp medical ethics/OR opinion$.tw OR exp attitude/OR exp health belief/OR attitude$.tw OR belie$.tw OR feel$.tw OR know$.tw OR understand$.tw |
a (P and I and O).
The terms used in the PICOS search
P | [MH Multiple Sclerosis OR TX multiple sclerosis] AND MH patients OR TX service user* or TX service-user* | [exp multiple sclerosis/OR multiple sclerosis.tw]AND [exp Patients/OR patient*.tw OR service user*.tw OR service-user*.tw OR exp consumer participation/ OR consumer.tw] | [exp multiple sclerosis/OR multiple sclerosis.tw] AND [exp patient/patient$.tw OR service user$.tw OR service-user$ OR consumer$.tw] |
I | MH (health services needs and demands) OR TX health care OR TX health services OR TX care OR MH patient care OR MH health personnel OR MH health services administration OR MH health services OR MH health facilities OR MH mental health services OR MH therapeutics OR TX specialist care MM “Multiple Sclerosis Psychosocial Factors” OR MM “Multiple sclerosis diagnosis” OR MM “Multiple sclerosis drug therapy” | exp “health care facilities, manpower and services”/OR health care.tw OR health services.tw OR exp Health Services Administration/OR exp Therapeutics/OR exp Diagnosis/OR organisations.tw OR exp Health Occupations/OR consultation.tw OR referral.tw OR exp Health Personnel/OR Health Education/OR hospital*.tw OR consultant*.tw OR neurologist*.tw OR doctor* OR practice nurse*.tw OR specialist nurse* OR psychologist*.tw OR general practitioner*.tw OR exp “psychiatry and psychology (non mesh)”/OR exp/Dentistry/OR exp investigative techniques/ OR exp “health care economics and organisations”/OR specialist care.tw OR mental health services.tw OR mental health care.tw OR secondary care.tw | exp health care/OR health care.tw OR exp health service/OR exp health care organisation/ OR exp health care utilization/OR exp “care and caring”/OR care.tw OR medical care.tw OR exp health care personnel/OR health service$.tw OR health care professional$.tw OR exp health care quality/OR exp terminal care/OR exp health care management/OR exp medical procedures/OR exp health care facility/OR hospital$.tw OR welfare/or *human needs/or *social welfare OR exp medical ethics/OR consultant$.tw OR neurologist$.tw OR doctor$.tw OR practice nurse$.tw OR specialist nurse$.tw OR psychologist$.tw OR general practitioner$.tw OR mental health care.tw OR mental health services.tw or psycholog$ services.tw OR specialist care.tw OR secondary care.tw OR primary care.tw OR primary health care.tw |
C | n/a | n/a | n/a |
O | TX perception* OR MH patient satisfaction OR TX satisf* OR TX value* OR TX perceive* OR TX perspective* OR TX view* OR TX experience OR MH (health services needs and demand) OR TX opinion* OR MH consumer satisfaction OR TX belie* OR MM “Patient Attitudes” OR MM “Attitude to illness” | perceive*.tw OR perception*.tw OR exp Consumer Participation/OR *personal satisfaction/OR exp Consumer Satisfaction/ OR satis*.tw OR exp Hospital-Patient Relations/OR exp Professional- Patient Relations/OR value*.tw OR perspective*.tw OR view*.tw OR experience*.tw OR need*.tw OR exp “Health Services Needs and Demand”/OR issue*.tw OR exp Attitude/OR belie*.tw OR opinion*.tw OR feel*.tw OR know*.tw OR understand*.tw | Perception$.tw OR exp satisfaction/OR satis$.tw OR value$.tw OR perceive$.tw OR exp psychological aspect/OR perspective$.tw OR view$.tw OR exp personal experience/OR experience$.tw OR exp health care need/OR need$.tw OR exp human needs/OR issue$.tw OR exp medical ethics/ OR opinion$.tw OR exp attitude/OR exp health belief/OR attitude$.tw OR belie$.tw OR feel$.tw OR know$.tw OR understand$.tw |
S | AB qualitative OR MH qualitative studies | Exp Qualitative Research/OR qualitative.mp AB qualitative OR MH qualitative studies | Qualitative.tw OR qualitative analysis.tw OR exp qualitative research/ |
a (P AND I AND C AND O AND S).
One reviewer judged titles and abstracts against the inclusion criteria. If a title and abstract met the inclusion criteria then full text copies of all articles were retrieved for further investigation. Two authors reviewed these full text articles independently for relevance to the search aim (i.e. patients/service users with multiple sclerosis, experiences of health care services and qualitative research). Any disagreements were resolved via discussion. Data from included studies were extracted by both reviewers independently to ensure accuracy and then stored on a Microsoft Excel spread sheet. No ethical approval was required for this study.
All searches spanned from database inception until 12th October 2013. As in Cooke et al. [ 9 ], we reviewed our findings based on two metrics; the number of hits generated and of these, the number relevant to the search aim (see Table 5 ).
Hits generated and articles searched
CINAHL plus | 1350 | After abstract and title =78 | 146 | After abstract and title =56 | 146 | After abstract and title =56 |
After full review =14 | After full review =12 | After full review =12 | ||||
EMBASE | 14250 | After abstract and title =35 | 189 | After abstract and title =15 | 55 | After abstract and title =9 |
After full review =14 | After full review =7 | After full review =3 | ||||
MEDLINE | 8158 | After abstract and title =34 | 113 | After abstract and title =16 | 38 | After abstract and title =14 |
After full review =12 | After full review =6 | After full review =5 |
As found in Cooke et al. [ 9 ], PICO created a much greater number of hits compared to SPIDER. A total of 23758 hits were generated using PICO, 448 hits were generated using PICOS and 239 hits were generated using SPIDER. Overall, the average reduction of hits (% across all three databases) was 98.58% for SPIDER vs. PICO, 97.94% for PICO vs. PICOS and 68.64% for PICOS vs. SPIDER. The time spent screening hits for relevant articles equated to weeks for the PICO hits and hours for the PICOS and SPIDER hits.
Articles which met the inclusion criteria after full text review are displayed in Table 6 [ 16 - 33 ]. Examination of the titles and abstracts of the identified articles resulted in the obtainment of 18 full text articles relevant at full text, across all databases and search tools.
Articles identified by database and search tool
Lohne et al. [ ]. | The lonely battle for dignity | X | X | X | X | X | X | X | X | |
Mackereth et al. [ ]. | What do people talk about during reflexology | X | X | |||||||
Isaksson, and Ahlström [ ]. | Managing chronic sorrow | X | X | X | X | X | X | X | X | |
Edwards, Barlow & Turner [ ]. | Experiences of diagnosis and treatment among people with MS | X | X | X | X | X | X | X | X | X |
Barker-Collo, Cartwright & Read [ ]. | Into the unknown: The experiences of individuals | X | X | X | X | X | ||||
Isaksson, & Ahlström [ ]. | From symptoms to diagnosis | X | X | X | X | X | X | X | X | |
Miller & Jezewski [ ]. | Relapsing MS patients experiences with galtiramer acetate | X | X | X | X | X | X | X | X | X |
Johnson [ ]. | On receiving the diagnosis of ms | X | X | |||||||
Miller & Jezewski [ ]. | A phenomenologic assessment of relapsing MS patients’ experiences during treatment with Interferon Beta-1(*) | X | X | X | X | X | X | X | ||
Miller [ ]. | The lived experience of relapsing ms | X | X | X | X | X | ||||
Aars & Bruusgaard [ ]. | Chronic disease and sexuality: An interview study | X | X | |||||||
Rintell et al. [ ]. | Patients’ perspectives on quality of mental health care | X | X | X | ||||||
Laidlaw & Henwood [ ]. | Patients with multiple sclerosis: Their experiences and perceptions of MRI | X | X | X | ||||||
Koopman & Schweitzer [ ]. | The journey to multiple sclerosis | X | X | X | ||||||
Hansen, Krogh, Bangsgaard & Aabling [ ]. | Facing the diagnosis | X | ||||||||
Loveland [ ]. | The experiences of African Americans and Euro-Americans with multiple sclerosis | X | X | X | ||||||
Moriya & Suzuki [ ]. | A qualitative study relating to the experiences of people with MS | X | X | X | ||||||
Classen & Lou [ ]. | Exploring rehabilitation and wellness needs of people with MS living in South Florida | X | X | X |
For the PICO tool in CINAHL Plus, 5.78% of hits were deemed relevant after the title and abstract stage (78 articles/1350 articles), and 14/78 articles (17.95%) were confirmed to meet the inclusion criteria after full text review. For the PICO tool in MEDLINE, 0.42% of hits were deemed relevant after the title and abstract stage (34 articles/8158 articles) and 12/34 (35.29%) articles were confirmed to meet the inclusion criteria after full text review. For the PICO tool in EMBASE, 0.25% hits were deemed relevant after the title and abstract stage (35 articles/ 14250 articles) and 14/35(40%) articles were confirmed to meet the inclusion criteria after full text review.
For the PICOS tool in CINAHL Plus, 38.36% of articles were relevant after the title and abstract stage (56 articles/146 articles) and 12/56 (21.43%) were confirmed to meet the inclusion criteria after full text review. For the PICOS tool in MEDLINE 14.16% of articles were relevant after the title and abstract stage (16 articles/ 113 articles) and 6/16 (37.5%) were confirmed to meet the inclusion criteria after full text review. For the PICOS tool in EMBASE 7.94% of articles were deemed relevant after the title and abstract stage (15 articles/189 articles) and 7/15 (46.67%) were confirmed to meet the inclusion criteria after full text review.
For the SPIDER tool in CINAHL Plus 38.36% of articles were relevant after the title and abstract stage (56 articles/146 articles) and 12/56 (21.43%) were confirmed to meet the inclusion criteria after full text review. For the SPIDER tool in MEDLINE, 36.81% hits were deemed relevant at the title stage (14 articles/38 articles) and 5/14 articles (35.71%) were confirmed to meet the inclusion criteria after full text review. For the SPIDER tool in EMBASE, 16.36% were relevant at the title stage (9 articles/55 articles) and 3/9 (33.33%) were confirmed to meet the inclusion criteria after full text review.
The SPIDER tool identified 13 relevant articles out of 239 articles across all three databases (5.43%) compared to PICOS which identified 13 articles out of 448 articles (2.90%) and PICO which identified 18 articles out of 23758 articles (0.076%). Of the 18 relevant articles identified by the PICO tool, 66.66% came from both MEDLINE and CINAHL Plus (12 articles each), and 72.22% came from EMBASE (13 articles). Of the 13 relevant articles identified by the PICOS tool 46.15% came from MEDLINE (6 articles), 53.84% came from EMBASE (7 articles) and 92.31% came from CINAHL Plus (12 articles). Of the 13 relevant articles identified by SPIDER, 38.46% came from MEDLINE (5 articles) and 23.07% came from EMBASE (3 articles) and 92.30% came from CINAHL Plus (12 articles) Table 7 .
Sensitivity and specificity for each search tool by database
CINAHL PICO | 14/18 = 77.78 | 14/1350 = 1.04 |
CINAHL PICO S | 12/18 = 66.67 | 12/146 = 8.22 |
CINAHL SPIDER | 12/18 = 66.67 | 12/146 = 8.22 |
MEDLINE PICO | 12/18 66.67 | 12/8158 = 0.15 |
MEDLINE PICO S | 6/18 = 33.33 | 6/113 = 5.32 |
MEDLINE SPIDER | 5/18 = 27.78 | 5/14 = 35.71 |
EMBASE PICO | 13/18 = 72.22 | 14/14250 = 0.1 |
EMBASE PICO S | 7/18 = 38.88 | 7/189 = 3.7 |
EMBASE SPIDER | 3/18 = 16.67 | 3/55 = 5.45 |
Different articles were found across different tools and databases (as shown in Table 6 ). All three databases were checked for all articles. One article was available in CINAHL Plus but not identified by any of the tools [ 17 ]. Two papers were identified in all databases through all search tools. Five papers were identified in MEDLINE through all search tools, three identified in EMBASE through all search tools and 12 identified in CINAHL through all search tools. Five papers were identified solely in CINAHL Plus, with one of these papers only identified using the PICO search method. One paper was identified by all search tools in EMBASE but not identified by any in MEDLINE. No new studies were identified using the SPIDER or PICOS tools alone in any database.
In this article we addressed the aim of replicating a comparison between the SPIDER, PICOS and PICO search tools. As previously described in Cooke et al. [ 9 ], the SPIDER tool produced a greatly reduced number of initial hits to sift through, however in this study it missed five studies that were identified through the PICO method. This may be partly be explained by the nature of the research question prompting the search. As this study included subthemes of studies whose focus differed from the initial research question (i.e. only a smaller section of the paper related to health care) then it’s possible that these studies were picked up by a broader search but not the highly specific SPIDER search. Other authors researching the process of qualitative literature reviews have previously commented that there appears to be a decision to be made about the benefits of comprehensiveness of findings versus the accuracy of the studies identified [ 11 ]. Given the common nature of using sub-sections of papers for systematic reviews then our findings suggest that comprehensiveness needs to be the key for this type of search.
The PICOS tool was more specific than the PICO tool, but did not identify any additional relevant hits to the SPIDER tool, suggesting it is of approximately equal sensitivity. PICOS identified the same number of papers as the SPIDER tool and both demonstrated a substantially lower number of hits generated than a regular PICO search. The SPIDER tool showed the greatest specificity due the small number of hits generated. This may mean that review teams with very limited resources or time, and who are not aiming for a totally comprehensive search (i.e. in the case of scoping studies), would benefit from using the SPIDER tool. This might be applicable particularly to studies such as qualitative syntheses, where the research aim is theoretical saturation, not a comprehensive search [ 34 ]. In addition, articles written to influence policy often require swift publication, providing another area in which either SPIDER or PICOS might improve current practice.
The issue of time was also related to the number of relevant articles identified per database. Whilst EMBASE generated nearly twice as many hits as MEDLINE, only one additional paper was found. The PICO tool identified all articles, suggesting that where time is not a factor, it might be of more benefit to use this tool, as SPIDER demonstrated lower sensitivity, did not identify any new articles and identified fewer relevant articles than PICO.
Our findings indicate that it is worthwhile testing a chosen search tool across various databases as they produce different results; i.e. CINHAL Plus identified papers not identified in MEDLINE or EMBASE databases. It is therefore important for future research to investigate the potential of the SPIDER vs. PICOS and PICO tools as a base for the recommended comprehensive searching process, by investigating the contribution of the SPIDER and PICOS tools at every stage from the initial search hits, to the final included relevant articles.
As CINAHL is a database dedicated to nursing and allied health research, it was expected that it would produce a greater number of relevant articles than more medically focussed databases [ 10 ], as nursing and allied areas have traditionally been at the forefront of qualitative investigations into Multiple Sclerosis.
SPIDER proved to be a tool designed to formulate search terms easily, as it naturally fits the crucial elements of the search question. However, even though some qualitative keywords are necessary to identify qualitative studies, including the words “ qualitative research ” AND the name of the type of research e.g. “ grounded theory ” might be too restrictive, particularly given the poor use of the qualitative index term, and might partially explain the fewer studies identified by SPIDER in comparison to PICO. Studies not identified by the SPIDER model in MEDLINE and EMBASE databases did not use keywords such as “ qualitative ”, but some described qualitative methods, such as “ phenomenological-hermeneutic ” [ 16 ] or “ interview(s) ” [ 20 , 23 ].
In all PICO searches for MEDLINE and EMBASE the word “ qualitative ” combined with the phrase “ multiple sclerosis ” identified many quantitative studies reporting brain scan assessments that were wholly unrelated to the search aim. This was because the word “ qualitative ” in this context referred to using a qualitative method to provide information about the quality of the scan and any potential flaws [ 35 ]. This caused a problem with specificity, resulting in thousands of inappropriate hits as there was no way to exclude studies with the word “ qualitative ” unless all articles clearly utilised and indexed qualitative research methods in the title, abstract and keywords.
Many studies were excluded at the full text stage on the basis that the samples were mixed: being comprised of either various neurological conditions or mixed groups of people i.e. patients and carers/patients and health care professionals and so forth. Without clearer titles and abstracts, and potentially an indexing phrase that indicates mixed samples, there is no way of avoiding this issue. Excluding the phrases “ caregivers ” or “ health care professionals ” would have excluded any studies that used these phrases (for example in the introduction or implication for future research sections) and therefore it is difficult to see how this could be prevented. A strength and limitation of our study is that whilst it details a real world example of evidence searching, it only addresses one topic. Further research should test these search tools against a wider variety of narrative review and meta-synthesis topics.
SPIDER greatly reduced the initial number of articles identified on a given search due to increased specificity, however because of lower sensitivity omitted many relevant papers. The PICOS tool resulted in an overall more sensitive search, but still demonstrated poor specificity on this topic. Further investigations of the specificity and sensitivity of SPIDER and PICOS on varied topics will be of benefit to research teams with limited time and resources or articles necessary to impact on policy or change current practice. However, where comprehensiveness is a key factor we suggest that the PICO tool should be used preferentially. Part of the lower identification rate for SPIDER (in comparison to PICO) was poor labelling and use of qualitative keywords in indexing studies. As both individual research submissions and journal/database indexers improve, or standardise, the indexing of qualitative studies, it is likely that the relevance of the SPIDER tool will increase. The recommendation for current practice therefore is to use the PICO tool across a variety of databases. In this article we have shown that SPIDER is relevant for those researchers completing systematic narrative reviews of qualitative literature but not as effective as PICO. Future research should investigate the use of SPIDER and PICOS across varied databases.
This study was funded by a School for Primary Care Research PhD studentship from the National Institute of Health Research. Support in selecting search terms is acknowledged from Olivia Walsby, Academic Engagement Librarian at the University of Manchester. We are grateful to Professor Peter Bower for his comments on the protocol.
Competing interests
The authors declare that they have no competing interests.
Authors’ contributions
AM designed the study, conducted all searches, appraised all potential studies and wrote and revised the draft manuscript and subsequent manuscripts. SC made significant contributions to the conception and design of the study, assisted with the presentation of findings and assisted with drafting and revising the manuscript. CCG and RM made significant contributions to the conception and design of the study, assisted with the presentation of findings and assisted with drafting and revising the manuscript. SCS conceived and designed the study, assisted with searches, appraised relevant studies and assisted with drafting and revising the manuscript. All authors read and approved the final manuscript.
Authors’ information
Caroly Chew-Graham is part-funded by the National Institute for Health Research (NIHR) Collaborations for Leadership in Applied Health Research and Care West Midlands.
Abigail M Methley, Email: [email protected] .
Stephen Campbell, Email: [email protected] .
Carolyn Chew-Graham, Email: [email protected] .
Rosalind McNally, Email: [email protected] .
Sudeh Cheraghi-Sohi, Email: [email protected] .
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CDC vaccine recommendations are developed using an explicit evidence-based method based on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.
A Grading of Recommendations, Assessment, Development and Evaluation (GRADE) review of the evidence for benefits and harms for Novavax coronavirus disease 2019 (COVID-19) vaccine was presented to the Advisory Committee on Immunization Practices (ACIP) on July 19, 2022. GRADE evidence type indicates the certainty in estimates from the available body of evidence. Evidence certainty ranges from type 1 (high certainty) to type 4 (very low certainty) 1 .
The policy question was, "Should vaccination with Novavax COVID-19 vaccine be recommended for persons 18 years of age and older during an Emergency Use Authorization?" The potential benefits pre-specified by the ACIP COVID-19 Vaccines Work Group were prevention of symptomatic laboratory-confirmed COVID-19 (critical), hospitalization due to COVID-19 (critical), death due to COVID-19 (important), and asymptomatic SARS-CoV-2 infection (important). The two pre-specified harms were serious adverse events (critical) and reactogenicity grade ≥3 (important).
A systematic review of evidence on the efficacy and safety of a two-dose regimen of Novavax COVID-19 vaccine among persons aged 18 years and older was conducted. The quality of evidence from one Phase III randomized controlled trial was assessed using a modified GRADE approach. 2 3
A lower risk of symptomatic COVID-19 was observed with vaccination compared to placebo (relative risk [RR] 0.10, 95% confidence interval [CI]: 0.06, 0.18, evidence type 1), corresponding to a vaccine efficacy of 89.6% (95% CI: 82.4%, 93.8%). This was observed with a median follow-up of 2.5 months, during a period of Alpha variant predominance. The vaccine was also associated with a lower risk of severe illness due to COVID-19 (RR 0.00; 95% CI: 0.00, 1.00; evidence type 3), corresponding to a vaccine efficacy of 100% (95% CI: 0%, 100%). The measure of severe COVID-19 was used as surrogate for the GRADE outcome of hospitalization due to COVID-19. No hospitalizations or deaths due to COVID-19 were identified among vaccine recipients or placebo recipients in the per-protocol population.*
In terms of harms, the available data indicated that serious adverse events were balanced between the vaccine and placebo arms (RR 0.92; 95% CI: 0.73, 1.16; evidence type 1). Reactogenicity grade ≥3 was associated with vaccination (RR 4.11; 95% CI: 3.70, 4.57; evidence type 1), 16.3% of vaccine recipients and 4% of placebo recipients reported any grade ≥3 local or systemic reactions following either dose 1 or dose 2.
On July 13, 2022, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Novavax COVID-19 (NVX-CoV2373) vaccine for prevention of symptomatic COVID-19 for persons aged ≥18 years. 4 As part of the process employed by the ACIP, a systematic review and GRADE evaluation of the evidence for Novavax COVID-19 vaccine was conducted and presented to ACIP. The ACIP adopted a modified GRADE approach in 2010 as the framework for evaluating the scientific evidence that informs recommendations for vaccine use. Evidence of benefits and harms were reviewed based on the GRADE approach. 1
The policy question was, "Should vaccination with Novavax COVID-19 vaccine be recommended for persons 18 years of age and older under an Emergency Use Authorization?" (Table 1).
We conducted a systematic review of evidence on the efficacy and safety of a two-dose regimen of Novavax (5 μg antigen plus 50 μg Matrix-M adjuvant) COVID-19 vaccine. We assessed outcomes and evaluated the quality of evidence using the GRADE approach.
During Work Group calls, members were asked to pre-specify and rate the importance of relevant patient-important outcomes (including benefits and harms) before the GRADE assessment. No conflicts of interest were reported by CDC and ACIP COVID-19 Vaccines Work Group members involved in the GRADE analysis. Outcomes of interest included individual benefits and harms (Table 2). The critical benefits of interest are prevention of symptomatic laboratory-confirmed COVID-19 and prevention of hospitalization due to COVID-19. Other important outcomes include prevention of death due to COVID-19 and prevention of asymptomatic SARS-CoV-2 infection. The critical harm of interest was serious adverse events; reactogenicity grade ≥3 was deemed an important harm.
We identified clinical trials through clinicaltrials.gov. Records of relevant Phase I, II, or III RCTs of COVID-19 vaccine were included if they 1) provided data on persons aged ≥18 years vaccinated with NVX-CoV2373; 2) involved human subjects; 3) reported primary data; and 4) included data relevant to the efficacy and safety outcomes being measured. We identified relevant observational studies through an ongoing systematic review conducted by the International Vaccine Access Center (IVAC) and the World Health Organization (WHO). 4 Relevant observational studies were restricted to the defined population, intervention, comparison, and outcome outlined in the policy question, or related outcomes if direct data were not available. In addition, unpublished and other relevant data were obtained by hand-searching reference lists, and consulting with vaccine manufacturers and subject matter experts. The systematic review was limited to studies published from January 1, 2020 to July 7, 2022. Characteristics of all included studies are shown in Appendix 1 and evidence retrieval methods are found in Appendix 2.
The evidence certainty assessment addressed risk of bias, inconsistency, indirectness, imprecision, and other characteristics. The GRADE assessment across the body of evidence for each outcome was presented in an evidence profile; the evidence certainty of Type 1, 2, 3, or 4 corresponds to high, moderate, low, or very low certainty, respectively.
Relative risks (RR) were calculated from numerators and denominators available in the body of evidence. Vaccine efficacy estimates were defined as 100% x (1-RR).
The initial GRADE evidence level was type 1 (high) for each outcome because the body of evidence was from a randomized controlled trial (Table 4). In terms of critical benefits, the available data indicated that the vaccine was effective for preventing symptomatic COVID-19 during a period of Alpha variant predominance, and no serious concerns impacting certainty in the estimate were identified (type 1, high). The certainty in the effect estimate for severe illness due to COVID-19 was downgraded one point for serious concern of indirectness because severe illness due to COVID-19 was evaluated as a surrogate for hospitalization due to COVID-19 and one point for serious concern of imprecision due to the small number of events during the observation period (type 3, low). No serious concerns impacted the certainty in the estimate for serious adverse events or reactogenicity (both type 1, high) (Table 4).
* Cases were included in the analysis if they were confirmed in a designated central laboratory, per manufacturer protocol
† Additional studies which evaluated the Novavax vaccine were excluded as the vaccines were manufactured at a different facility and by a different process
Abbreviations : IM = intramuscular.
a Assessed through serial PCR testing.
Outcome | Importance | Included in evidence profile |
---|---|---|
Symptomatic laboratory-confirmed COVID-19 | Critical | Yes |
Hospitalization due to COVID-19 | Critical | Yes |
Death due to COVID-19 | Important | No |
Asymptomatic SARS-CoV-2 infection | Important | No |
Serious adverse events | Critical | Yes |
Reactogenicity grade ≥3 | Important | Yes |
a Severe illness due to COVID-19 evaluated as a surrogate measure for this critical outcome.
b No events occurred in the study included in the review of evidence.
c Data were not available to inform an evaluation of asymptomatic SARS-CoV-2 infection in studies identified in the review of evidence.
References in this table: 2 3
Authors last name, pub year | Age or other characteristic of importance | n/N intervention | n/N comparison | Comparator | Vaccine Efficacy (95% CI) [100 x (1-RR)] | Study limitations (Risk of Bias) |
---|---|---|---|---|---|---|
Novavax, 2021 [ , ] | Primary outcome SARS-CoV-2 RT-PCR-positive symptomatic illness , in seronegative persons aged ≥18 years, ≥7 days post vaccination | 17/17272 | 79/8385 | Placebo | 89.6% (82.4%, 93.8%) | Not serious |
Abbreviations: RT-PCR = real-time polymerase chain reaction; CI = confidence interval; RR = relative risk.
a 19,965 and 9,984 persons were randomized to vaccine and placebo
b Primary outcome, defined as SARS-CoV-2 RT-PCR-positive symptomatic illness, in seronegative adults, ≥7 days post vaccination.
c Symptomatic illness defined as any mild, moderate or severe COVID-19. Mild COVID-19 was defined as fever, new onset cough OR ≥2 additional COVID-19 symptoms: pyretic, new onset or worsening of shortness of breath or difficulty breathing compared to baseline, new onset fatigue, new onset generalized muscle or body aches, new onset headache, new loss of taste or smell, acute onset of sore throat, congestion, and runny nose, or new onset nausea, vomiting, or diarrhea. Moderate COVID-19 was defined as high fever (≥38.4°C) for ≥3 days or any evidence of significant lower respiratory tract infection. Severe COVID-19 was defined as any of the following symptoms: tachypnea: ≥ 30 breaths per minute at rest, resting heart rate ≥125 beats per minute, oxygen saturation ≤93% on room air or ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen <300 mm Hg, high flow oxygen therapy or non-invasive ventilation/non-invasive positive pressure ventilation, mechanical ventilation or extracorporeal membrane oxygenation, one or more major organ system dysfunction or failure.
d Based on data cutoff September 27, 2021; participants had a median of two months follow-up.
References in this table: 3
Authors last name, pub year | Age or other characteristic of importance | |||||
---|---|---|---|---|---|---|
Novavax, 2021 [ ] | Severe COVID-19 in persons aged ≥18 years with no evidence of prior infection, ≥7 d after vaccination | 0/17272 | 4/8385 | Placebo | 100 (0,100) | Not serious |
Abbreviations: CI = confidence interval; RR = relative risk; NE=Not estimable
a Severe COVID-19 was defined as any of the following symptoms: tachypnea: ≥ 30 breaths per minute at rest, resting heart rate ≥125 beats per minute, oxygen saturation ≤93% on room air or ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen <300 mm Hg, high flow oxygen therapy or non-invasive ventilation/non-invasive positive pressure ventilation, mechanical ventilation or extracorporeal membrane oxygenation, one or more major organ system dysfunction or failure.
b Based on data cutoff September 27, 2021.
Authors last name, pub year | Age or other characteristic of importance | n/N (%) intervention | n/N (%) comparison | Comparator | ||
---|---|---|---|---|---|---|
Novavax, 2021 [ ] | Phase III RCT, persons aged ≥18 years | 199/19735 (1.0%) | 108/9847 (1.1%) | Placebo | 0.92 (0.73, 1.16) | Not serious |
Abbreviations: RR = relative risk; CI = confidence interval; RCT = randomized controlled trial.
a Death, life-threatening event, hospitalization, incapacity to perform normal life functions, medically important event, or congenital anomaly/birth defect
b Five participants in the vaccine arm experienced SAEs that were considered related to vaccination by the investigator (n=1 each of headache, angioedema, Basedow's disease, thrombocytopenia, nervous system disorder). Among these, FDA considered the event of angioedema as potentially related to vaccination. There was one event of myocarditis in a 67-year-old male, with concomitant COVID-19 infection, 28 days after dose 1, which was not considered related to vaccination. Additional cases of myocarditis were observed after placebo crossover
Authors last name, pub year | Age or other characteristic of importance | Comparator | RR (95% CI) | Study limitations (Risk of Bias) | ||
---|---|---|---|---|---|---|
Novavax, 2021 [ ] | Phase III RCT, persons aged ≥18 years | 3048/18725 (16.3%) | 366/9237 (4.0%) | Placebo | 4.11 (3.70, 4.57) | Not serious |
Abbreviations: RR = relative risk; CI = confidence interval.
a Reactogenicity outcome includes local and systemic events, grade ≥3. For local reactions, grade 3 pain or tenderness defined as any narcotic pain reliever or prevents daily activity, grade 4 defined as emergency department visit or hospitalization. Grade 3 redness or swelling is defined as >10 cm or prevents daily activity, grade 4 is necrosis or exfoliative dermatitis. For systemic reactions, grade 3 fever defined as 39.0 to 40.0 °C, grade 4 defined as >40°C. Grade 3 headache, fatigue/malaise, muscle pain, and joint pain defined as any use of narcotic pain reliever or prevents daily activity, grade 4 defined as emergency department visit or hospitalization. Grade 3 nausea/vomiting defined as prevents daily activity or requires outpatient IV hydration, grade 4 defined as emergency department visit or hospitalization for hypotensive shock.
b Based on interim analysis, data cutoff September 27, 2021.
Certainty assessment | № of patients | Effect | Certainty | Importance | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
№ of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Novavax COVID-19 vaccine, 5 mcg antigen plus 50 mcg Matrix-M adjuvant, 2 doses, 21 days apart | No COVID-19 vaccine | Relative (95% CI) | Absolute (95% CI) | ||
Symptomatic laboratory-confirmed COVID-19 | ||||||||||||
1 | RCT | not serious | not serious | not serious | not serious | none | 17/17272 (0.1%) | 79/8385 (0.9%) | (0.06 to 0.18) | (from 886 fewer to 773 fewer) | High | CRITICAL |
Severe Illness due to COVID-19 | ||||||||||||
1 | RCT | not serious | not serious | serious | serious | none | 0/17272 (0.0%) | 4/8385 (0.0%) | (0.00 to 1.00) | (from 0 fewer to 48 fewer) | Low | CRITICAL |
Serious adverse events | ||||||||||||
1 | RCT | not serious | not serious | not serious | not serious | none | 199/19735 (1.0%) | 108/9847 (1.1%) | (0.73 to 1.16) | (from 296 fewer to 175 more) | High | CRITICAL |
Reactogenicity, grade ≥3 | ||||||||||||
1 | RCT | not serious | not serious | not serious | not serious | none | 3048/18725 (16.3%) | 366/9237 (4.0%) | (3.70 to 4.57) | (from 10,698 more to 14,146 more) | High | IMPORTANT |
Abbreviations: CI = confidence interval; RR = relative risk; COVID-19 = coronavirus disease 2019; RCT = randomized controlled trial.
a. Risk of bias related to blinding of participants and personnel was present. Although participants and study staff were blinded to intervention assignments, they may have inferred receipt of vaccine or placebo based on reactogenicity. This was deemed unlikely to overestimate efficacy or underestimate risk of serious adverse events, therefore the risk of bias was rated as not serious.
b. Concern for indirectness was noted due to the short duration of observation in the available body of evidence. The vaccine efficacy observed at a median 2-month follow-up may differ from the efficacy observed with ongoing follow-up. However, in consideration that this recommendation is under an Emergency Use Authorization, the length of follow up time was deemed sufficient to support efficacy in that context. Additionally, it should be noted that the efficacy assessment took place during Alpha variant predominance and efficacy may differ for other variants.
c. The effects noted are from a per protocol analysis with outcomes assessed at least 7 days post dose 2 among persons who received two doses and had no evidence of prior SARS-CoV-2 infection.
d. The RCT excluded persons with prior COVID-19 diagnosis, pregnant women or women planning to become pregnant within 3 months of vaccination, and persons who were immunocompromised due to conditions and/or treatments (participants with stable/well-controlled HIV infection were not excluded). The population included in the RCT may not represent all persons aged ≥18 years.
e. Absolute risk was calculated using the observed outcomes in the placebo arm during the available clinical trial follow-up. Absolute risk estimates should be interpreted in this context.
f. Serious concern for indirectness was noted because severe illness due to COVID-19 is being evaluated as a surrogate for hospitalization due to COVID-19.
g. Serious concern for imprecision was noted due to the small number of events during the observation period.
h. There were no events in the vaccine group, therefore the relative risk was calculated using the standard offset of 0.5.
i. Absolute risk based on relative risk calculated using an offset due to zero events in the vaccine group
Last name first author, Publication year | Study design | Country (or more detail, if needed) | Total population | N Intervention | N comparison | Outcomes | Funding source | |
---|---|---|---|---|---|---|---|---|
Dunkle, 2022 [ ] | Phase III RCT | USA, Mexico | Persons aged ≥18 years | 29945 | 19963 | 9982 | Government, Industry |
a Additional data provided by sponsor.References in this table:
Abbreviations: SD = standard deviation; RCT = randomized controlled trial; COVID-19 = coronavirus disease 2019.
Database | Strategy |
---|---|
Relevant Phase 1, 2, or 3 randomized controlled trials of COVID-19 vaccine Search criteria: Unpublished and other relevant data by consulting with vaccine manufacturers and subject matter experts | |
Vaccine effectiveness estimate calculated comparing vaccinated to unvaccinated**
|
a. Most recent search conducted July 11, 2022.
ACIP comprises medical and public health experts who develop recommendations on the use of vaccines in the civilian population of the United States.
Systematic Reviews volume 13 , Article number: 237 ( 2024 ) Cite this article
Metrics details
The Brazilian Ministry of Health has developed and provided the Citizen’s Electronic Health Record (PEC e-SUS APS), a health information system freely available for utilization by all municipalities. Given the substantial financial investment being made to enhance the quality of health services in the country, it is crucial to understand how users evaluate this product. Consequently, this scoping review aims to map studies that have evaluated the PEC e-SUS APS.
This scoping review is guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) framework, as well as by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Checklist extension for scoping reviews (PRISMA-ScR). The research question was framed based on the “CoCoPop” mnemonic (Condition, Context, Population). The final question posed is, “How has the Citizen’s Electronic Health Record (PEC e-SUS APS) been evaluated?” The search strategy will be executed across various databases (LILACS, PubMed/MEDLINE, Scopus, Web of Science, ACM Digital Library, and IEEE Digital Library), along with gray literature from ProQuest Dissertation and Theses Global and Google Scholar, with assistance from a professional healthcare librarian skilled in supporting systematic reviews. The database search will encompass the period from 2013 to 2024. Articles included will be selected by three independent reviewers in two stages, and the findings will undergo a descriptive analysis and synthesis following a “narrative review” approach. Independent reviewers will chart the data as outlined in the literature.
The implementation process for the PEC e-SUS APS can be influenced by the varying characteristics of the over 5500 Brazilian municipalities. These factors and other challenges encountered by health professionals and managers may prove pivotal for a municipality’s adoption of the PEC e-SUS APS system. With the literature mapping to be obtained from this review, vital insights into how users have evaluated the PEC will be obtained.
The protocol has been registered prospectively at the Open Science Framework platform under the number 10.17605/OSF.IO/NPKRU.
Peer Review reports
The Brazilian Unified Health System (SUS) was launched in Brazil in 1998 [ 1 , 2 , 3 ]. Its structure adheres to a triad of principles: integrality, universality, and equity of health services offered to the nation’s population [ 4 ]. In 1990, Primary Health Care (PHC) was established as a national policy under Basic Operational Standard 96, which provided support for the implementation of Family Health and Community Health Agents programs throughout Brazil [ 5 , 6 ]. Currently, PHC has become a central component within the organization of the health care network and is considered the main entry point to the Brazilian health system, extending healthcare provision throughout the entire territory [ 3 , 7 , 8 ].
Examining Brazil’s demographic and epidemiological aspects is crucial to ensure these services reach all citizens. Hence, health policy planning depends on this information, which is typically sourced from healthcare system data [ 9 ]. This data may represent the reality and needs of a specific community, municipality, state, or country and, thus, directly influences health surveillance activities, forming the basis of health service management [ 10 ]. Health information systems aim to generate, organize, and analyze health indicators, thereby producing knowledge about the health status of the population [ 11 ].
To digitize SUS and facilitate health professionals’ efforts in care coordination, the Brazilian Ministry of Health instituted the e-SUS Primary Care Strategy in 2013. Its key objectives were to individualize records, integrate data between official systems, reduce redundancy in data collection, and computerize health units [ 12 ]. It is worth noting that this strategy extends beyond a federal management and national information system context; it touches on the daily routines of professionals, the challenges faced, and the information essential for individual care in territories [ 13 ]. To further facilitate this process, the Ministry introduced the Citizen’s Electronic Health Record (PEC), which is a freely available health information system for municipalities, aiding the computerization of Basic Health Units throughout Brazil [ 1 , 14 ].
The role of software products and intensive computer systems has grown to become essential for a broad array of business and personal operations. Consequently, achieving personal satisfaction, business success, and human security increasingly rely on the quality of these software and systems [ 15 ]. The development and implementation of these technologies are fundamental; however, they require substantial financial resources, and their success hinges on user acceptance [ 16 ]. Therefore, it is critical for those investing in technology to understand what factors affect acceptance and usage, aiding organizations in implementing user-level interventions [ 17 ].
Understanding how users evaluate a software product is critical in a nation of continental proportions like Brazil, especially given the significant financial investment to enhance health services’ quality. Given this context, this scoping review aims to map out the studies that have evaluated the PEC e-SUS APS using various quality models. This will be done using ISO/IEC 25010 as a theoretical foundation to define these models, which present in-depth quality models for computer systems, software products, data quality, and usage.
The protocol and its registration have been adapted based on elements taken from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Checklist extension for scoping reviews (PRISMA-ScR) [ 18 , 19 ]. The adapted protocol was subsequently registered on Open Science Framework under the number https://doi.org/10.17605/OSF.IO/NPKRU . The research question was formulated and structured around the CoCoPop approach (Condition, Context, and Population), as shown in Table 1 .
All studies evaluating the PEC e-SUS APS will be considered for the inclusion criteria. Given the myriad aspects of electronic health record systems open to analysis (e.g., user experience, usability, efficiency, accessibility, security, and economic aspects), this review will include studies evaluating the general function and effectiveness of the PEC e-SUS APS, regardless of the language. The exclusion criteria will include studies that will not clearly outline the evaluation method used for the health information system; will not employ an evaluative tool or method; will focus solely on medical records differing from the PEC e-SUS APS; will be published before 2013 (i.e., PEC e-SUS APS was first distributed to municipalities in 2013); will be conducted by authors from the Bridge Laboratory (i.e., the group responsible for the PEC implementation); will be review articles, letters, book chapters, conference abstracts, opinion articles, brief communications, editorials, and clinical guidelines; and if the full text will not found for full reading or correspondence authors will not reply to contact attempts.
A comprehensive search strategy will be deployed across various databases: LILACS, PubMed/MEDLINE, Scopus, Web of Science, ACM Digital Library, and IEEE Digital Library. Moreover, the gray literature will also be explored using the ProQuest Dissertation and Theses Global and Google Scholar databases with support from a healthcare librarian experienced in systematic reviews. The search strategy developed for the PubMed/MEDLINE databases is presented in Table 2 .
Furthermore, experts will be contacted for the potential inclusion of more studies, with manual searches of bibliographies from included studies and key journals also conducted. The database search will cover the period from 2013 until 2024. The search will be implemented in March 2024, and the results will be imported into the EndNote Online reference software (Thomson Reuters, USA).
Three independent reviewers will decide on what will be included in the final studies. In the first stage, the three reviewers will assess the titles and abstracts for eligibility. In the second stage, they will examine the full texts of the articles, applying the same criteria as in the first stage. The reviewers will then cross-validate all the information gathered during both stages. If disagreements occur, an arbitrator, not involved in the initial article selection stage, will be brought in before a final decision is reached. If review-critical data are missing or ambiguous, the study’s corresponding author will be contacted for resolution or clarification. The data mapping process and related entities will involve these same three independent reviewers.
A descriptive analysis will synthesize the results, following the narrative review approach of Pawson and Bellamy [ 20 ]. Independent reviewers will chart the data based on the method of Hilary Arksey and Lisa O’Malley (2005), as depicted in Table 3 .
In the event of discrepancies, a consensus discussion will ensue and, if necessary, independent reviewers will be brought in to reach a final decision. Any disagreements will be addressed among the reviewers. The corresponding author will be contacted if any crucial information is unclear or missing. The studies included will be grouped according to the various characteristics and sub-characteristics pertinent to all software products and computer systems, as defined by the ISO/IEC 25010–2011 standard .
Tabular summaries will be employed to present the findings and cover study characteristics, methodologies, and aspects evaluated. Subsequently, a narrative synthesis will be carried out to elucidate the evidence found relating to the review objective.
The success of PEC implementation can be influenced by various characteristics of municipalities, including their location, population density, level of urbanization, municipal management assistance, computerization levels, and technological infrastructure, among others [ 21 ]. These factors, coupled with the challenges confronted by healthcare professionals and managers, may determine a municipality’s adoption of the PEC. Literature emphasizes several barriers or difficulties encountered during implementation and usage, such as inadequate material resources in municipalities, lack of professional technology training, and poor internet connectivity [ 22 , 23 , 24 ].
Considering the myriad software product quality assessment models available, this review will utilize ISO/IEC 25010–2011 as its theoretical foundation. This model provides precise definitions of the attributes that must be evaluated. It is crucial to note that this international standard underwent rigorous evaluation by numerous international organizations before publication, reinforcing its suitability for assessing software product quality.
The literature map derived from this review will provide crucial insights into user evaluations of the PEC. Through these insights, it will be possible to identify the strengths and weaknesses of this software product. This knowledge will empower those responsible for developing and implementing this system to make significant improvements, thereby ensuring a substantial return on investment.
Not applicable.
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The authors would like to thank Mrs. Karyn Munik Lehmkuhl for her support with the search strategies.
This study will be financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior [Coordination for the Improvement of Higher Education Personnel] – Brazil (CAPES) – Finance Code 001, and by Brazilian Ministry of Health (e-SUS PHC Project Stage 6). The RSW and EMD are productivity fellows in technology development and innovative extension of CNPq.
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Mariano Felisberto, Júlia Meller Dias de Oliveira, Eduarda Talita Bramorski Mohr, Daniel Henrique Scandolara, Ianka Cristina Celuppi, Miliane dos Santos Fantonelli, Raul Sidnei Wazlawick & Eduardo Monguilhott Dalmarco
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Júlia Meller Dias de Oliveira
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Ianka Cristina Celuppi
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Felisberto, M., de Oliveira, J.M.D., Mohr, E.T.B. et al. Mapping the evaluation of the electronic health system PEC e-SUS APS in Brazil: a scoping review protocol. Syst Rev 13 , 237 (2024). https://doi.org/10.1186/s13643-024-02648-4
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A decade ago paper questionnaires were more common in epidemiology than those administered online, but increasing Internet access may have changed this. Researchers planning to use a self-administered questionnaire should know whether response rates to questionnaires administered electronically differ to those of questionnaires administered by post. We analysed trials included in a recently updated Cochrane Review to answer this question.
We exported data of randomised controlled trials included in three comparisons in the Cochrane Review that had evaluated hypotheses relevant to our research objective and imported them into Stata for a series of meta-analyses not conducted in the Cochrane review. We pooled odds ratios for response using random effects meta-analyses. We explored causes of heterogeneity among study results using subgroups. We assessed evidence for reporting bias using Harbord’s modified test for small-study effects.
Twenty-seven trials (66,118 participants) evaluated the effect on response of an electronic questionnaire compared with postal. Results were heterogeneous (I-squared = 98%). There was evidence for biased (greater) effect estimates in studies at high risk of bias; A synthesis of studies at low risk of bias indicates that response was increased (OR = 1.43; 95% CI 1.08–1.89) using postal questionnaires. Ten trials (39,523 participants) evaluated the effect of providing a choice of mode (postal or electronic) compared to an electronic questionnaire only. Response was increased with a choice of mode (OR = 1.63; 95% CI 1.18–2.26). Eight trials (20,909 participants) evaluated the effect of a choice of mode (electronic or postal) compared to a postal questionnaire only. There was no evidence for an effect on response of a choice of mode compared with postal only (OR = 0.94; 95% CI 0.86–1.02).
Postal questionnaires should be used in preference to, or offered in addition to, electronic modes.
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When collecting information from large, geographically dispersed populations, a self-administered questionnaire is usually the only financially viable option [ 1 ]. Non-responses to questionnaires reduce effective sample sizes, reducing study power, and may introduce bias in study results [ 2 ]. The Cochrane Methodology Review of methods to increase response to self-administered questionnaires has provided a much-used scientific evidence base for effective data collection by questionnaire since the publication of the first version of the review in 2003 which focused on postal questionnaires [ 3 ].
A decade ago paper-and-pencil administration of questionnaires in epidemiological studies was twenty times more common than electronic administration [ 4 ], but increased Internet access and decreasing volumes of mailed letters suggests that electronic administration has gained favour [ 5 , 6 , 7 ]. Researchers planning to collect data from participants using a self-administered questionnaire need to know how will the proportion of participants responding to a questionnaire administered electronically compare with one administered by post? We conducted further analyses of the trials included in the recently updated Cochrane Review [ 8 ] to answer this question.
To assess whether response rates to questionnaires administered electronically differ to those of questionnaires administered by post.
We exported data of randomised controlled trials included in the updated Cochrane Review [ 8 ] from RevMan and imported them into Stata for a series of meta-analyses not conducted in the Cochrane review.
We focused on data from trials included in three comparisons in the Cochrane Review that had evaluated hypotheses relevant to our research objective:
Postal vs. electronic questionnaire (Cochrane Comparison 81).
Electronic questionnaire only vs. choice (postal or electronic) (Cochrane Comparison 84).
Choice (electronic or postal) vs. postal questionnaire only (Cochrane Comparison 82).
These comparisons assess: response to questionnaires administered by post compared with questionnaires administered electronically, response to a questionnaire administered electronically compared with response when including a postal response option, and response when including an electronic response option compared with response to a questionnaire administered by post only, respectively.
The data obtained from each trial included the numbers of participants randomised to each arm of the trial with the numbers of completed, or partially completed questionnaires returned after all mailings (for trials including a postal questionnaire), and the numbers of participants randomised to each arm of the trial with the numbers of participants submitting the completed, or partially completed online questionnaires after all contacts (electronic questionnaire).
Additional data were also extracted on the:
Year of publication of the study.
Risk of bias in each included study (a judgment - high, low, or unclear); we assessed the overall risk of bias in each study using the Cochrane Collaboration’s tool [ 9 ].
For each of the three comparisons (2.1.1 above), we pooled the odds ratios for response in each included study in a random effects meta-analysis (to allow for heterogeneity of effect estimates between studies) using the metan command in Stata [ 10 ]. This command also produced a forest plot (a visual display of the results of the individual studies and syntheses) for each comparison. We quantified any heterogeneity using the I 2 statistic that describes the percentage of the variability in effect estimates that is due to heterogeneity [ 11 ].
We explored possible causes of heterogeneity among study results by conducting subgroup analyses according to two study-level factors: Year of study publication, and risk of bias in studies. We used a statistical test of homogeneity of the pooled effects in subgroups to assess evidence for subgroup differences. The statistical test of homogeneity used is Cochran’s Q test, where the Q statistic is distributed as a chi-square statistic with k-1 degrees of freedom, where k is the number of subgroups. If there was evidence for subgroup differences provided by the test of homogeneity, we chose the ‘best estimate of effect’ as the estimate from the subgroup of studies with low risk of bias, or the subgroup of studies published after 2012. If there was no evidence for subgroup differences, we chose our best estimate of effect based on the synthesis of all studies.
From 2012, household access to a computer exceeded 40%: [ 5 ] As the odds ratios for response to questionnaires administered electronically may be associated with household access to a computer, we analysed trial results in two subgroups – before 2012 and after 2012, where we used the year of publication as an approximation of the year of study conduct.
The odds ratios for response estimated in the included studies may be associated with trial quality. [ 12 , 13 ] For this reason we analysed trial results in two subgroups – trials judged to be at low and at high risk of bias.
We assessed evidence for reporting bias using Harbord’s modified test for small-study effects implemented in Stata using the metabias command [ 14 ]. This test maintains better control of the false-positive rate than the test proposed by Egger at al [ 14 ].
Thirty-five studies [ 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 ] reported 45 independent trials included in one or more of the three comparisons (Table 1 ). The studies were conducted in the US ( n = 20), Europe ( n = 13), and Australasia ( n = 2). The studies included between 133 and 12,734 participants and were published between 2001 and 2020. Eight studies were judged to be at high risk of bias [ 16 , 19 , 33 , 34 , 42 , 43 , 45 , 46 ].
Comparison 1 - postal vs. electronic questionnaire.
Twenty-seven trials (66,118 participants) evaluated the effect on questionnaire response of postal administration compared with electronic. [ 15 , 16 , 17 , 18 , 19 , 20 , 23 , 24 , 25 , 26 , 27 , 28 , 31 , 32 , 33 , 34 , 35 , 36 , 38 , 39 , 40 , 41 , 43 , 44 , 46 , 47 , 48 ] The odds of response were increased by over half (OR 1.76; 95% CI 1.34 to 2.32) using a postal questionnaire when compared with an electronic one (Fig. 1 ). There was considerable heterogeneity between the trial results (I-squared = 98%), but most of the studies showed response was greater with postal questionnaires than with electronic questionnaires, and the high I-squared is due to differences in the size of the benefit for postal questionnaires, rather than being due to an even spread of results between those favouring postal and those favouring electronic questionnaires.
Effect on response of mode of administration
Ten trials (39,523 participants) evaluated the effect on questionnaire response of providing a choice of response mode (postal or electronic) compared to an electronic questionnaire only [ 20 , 21 , 27 , 29 , 30 , 35 , 37 , 40 , 42 , 45 ]. The odds of response were increased by over half when providing a choice of response mode (OR 1.63; 95% CI 1.18 to 2.26; Fig. 2 ). There was considerable heterogeneity between the trial results (I-squared = 97.1%), but again, most of the studies favoured giving people the choice of response mode rather than electronic questionnaire only, and the high I-squared is due to differences in the size of the benefit for choice, rather than being due to an even spread of results between those favouring choice and those favouring electronic only.
Effect on response of choice of response mode compared with electronic only
Eight trials (20,909 participants) evaluated the effect of providing a choice of response mode (electronic or postal) compared to postal response only [ 20 , 22 , 27 , 29 , 34 , 35 , 40 , 49 ]. There was no evidence for an effect on response of providing a choice (OR 0.94; 95% CI 0.86 to 1.02; Fig. 3 ). There was moderate heterogeneity among the trial results (I-squared = 50.9%).
Effect on response of choice of response mode compared with postal only
Table 2 presents the results of subgroup analyses according to the two study-level factors (forest plots of these subgroup analyses are included in supplementary figures).
Year of publication.
A third of studies were published before 2012 [ 15 , 16 , 17 , 23 , 24 , 33 , 35 , 40 , 47 , 48 ]. In this subgroup of studies the odds of response were 85% greater (OR 1.85; 95% CI 1.12 to 3.06) with a postal questionnaire compared with an electronic one. In the subgroup of studies published after 2012 the effect was lower (OR 1.70; 1.19 to 2.43), consistent with our concern (Sect. 2.4.1 ) that higher household access to a computer from 2012 may have improved preference for electronic questionnaires, however the statistical test of homogeneity of the pooled effects in these two subgroups was not significant ( p = 0.788), indicating no evidence from these studies for different effects by year of study (Supplementary Fig. 1 a).
Seven of the trials [ 16 , 17 , 26 , 33 , 34 , 43 , 46 ] were judged to be at high risk of bias and for these trials the odds of response were more than tripled (OR 3.24; 95% CI 1.68 to 6.25) using a postal questionnaire when compared with an electronic one. There was considerable heterogeneity between the trial results (I-squared = 99%).
When only the 20 trials deemed to be at low risk of bias were synthesised, the odds of response were increased by two-fifths (OR 1.43; 95% CI 1.08 to 1.89). There was also considerable heterogeneity between these trial results (I-squared = 96.8%).
The statistical test of homogeneity of the pooled effects in these two subgroups ( p = 0.025) provides some evidence for greater effect estimates in studies at high risk of bias (Supplementary Fig. 1 b). Our best estimate of the effect on response of mode of administration is hence from a synthesis of the studies at low risk of bias (OR 1.43; 95% CI 1.08 to 1.89). Results overall were thus confounded by risk of bias, but this did not explain the between study heterogeneity.
Half of studies were published before 2012 [ 35 , 40 , 42 , 45 ]. In this subgroup of studies there was no evidence for an effect on response of providing a postal response option (OR 1.22; 95% CI 0.93 to 1.61). In the subgroup of studies published after 2012 there was evidence for an effect on response of providing a postal response option (OR 2.02; 95% CI 1.30 to 3.13). The statistical test of homogeneity of the pooled effects in these two subgroups was significant ( p = 0.057), indicating some evidence from these studies for different effects by year of study (Supplementary Fig. 2 a). This apparent preference for a postal response option in studies published after 2012 was counter to our concern (Sect. 2.4.1 ) that higher household access to a computer from 2012 would improve preference for electronic questionnaires. There was considerable heterogeneity between the trial results (I-squared = 98.2%), but most of the studies favoured giving people the choice of response mode rather than electronic questionnaire only, and the high I-squared is due to differences in the size of the benefit for choice, rather than being due to an even spread of results between those favouring choice and those favouring electronic only.
Two of the trials were judged to be at high risk of bias [ 42 , 45 ]. There was no evidence for an effect on response of a postal option in these studies (OR 1.08; 95% CI 0.43 to 2.71). When only the 8 trials deemed to be at low risk of bias were synthesised, there was evidence that the odds of response were increased when providing a postal response option (OR 1.77; 95% CI 1.23 to 2.55). There was considerable heterogeneity between these trial results (I-squared = 97.7%). The statistical test of homogeneity of the pooled effects in these two subgroups ( p = 0.326) provides no evidence for different effects by risk of bias (Supplementary Fig. 2 b). Our best estimate of the effect on response of providing a postal response option is hence from a synthesis of all of these studies (OR 1.63; 95% CI 1.18 to 2.26).
In the subgroup of studies published before 2012 there was very weak evidence that the odds of response were lower with an electronic option (OR 0.85; 0.73 to 0.98), whereas in studies published after 2012 there was no evidence for a difference between an electronic option and postal only – perhaps due to electronic methods being more acceptable with increased computer access. The results in both subgroups were more homogeneous (I-squared = 48.5% and 7.0% respectively). The statistical test of homogeneity of the pooled effects in these two subgroups ( p = 0.04) provides some evidence for different effects by year of study (Supplementary Fig. 3 a). If we consider the most recent trials to better represent the situation today (i.e., greater access to computers than prior to 2012), then our best estimate of the effect on response of providing an electronic response option is from a synthesis of the studies published after 2012 (OR 1.01; 95% CI 0.93 to 1.08), i.e., no evidence for an effect.
There was one study at high risk of bias [ 34 ]. Its results were entirely consistent with the results of the seven studies at low risk of bias (the statistical test of homogeneity of the pooled effects in these two subgroups was not significant ( p = 0.454), Supplementary Fig. 3 b).
There was no evidence for small study effects (Harbord’s modified test p = 0.148).
There was no evidence for small study effects (Harbord’s modified test p = 0.841).
There was no evidence for small study effects (Harbord’s modified test p = 0.139).
This study has shown that response to a postal questionnaire is more likely than response to an electronic questionnaire. It has also shown that response is more likely when providing the option for postal response with an electronic questionnaire. It has further shown that providing an electronic response option with a postal questionnaire has no effect on response. Response is thus increased using postal rather than electronic questionnaires.
A previous meta-analysis of 43 mixed-mode surveys from 1996 to 2006 also found paper and postal administration produced greater response than electronic administration [ 50 ]. Our result that providing an electronic response option to postal administration does not increase response is consistent with a previous meta-analysis of randomised trials that found that mailed surveys that incorporate a concurrent Web option have significantly lower response rates than those that do not [ 51 ].
We suggest two possible reasons for these results:
Paper questionnaires are more accessible than electronic questionnaires .
Although access to the Internet increased over the period during which the studies included in this study were conducted [ 5 , 52 ], a ‘digital divide’ [ 53 ] persists in many populations where completion of a paper questionnaire may be possible, but completion of an electronic one may not.
Paper questionnaires are more personal than electronic questionnaires .
Personalised materials have been shown to increase response [ 54 ]. If participants perceive a paper questionnaire with a return envelope to be more ‘personal’ than a request to go to a website to answer some questions, we should expect a higher response with paper.
The main strengths of this study are that our results are based on syntheses of the results of 45 randomised controlled trials that span two decades, and most of which were judged to be at low risk of bias.
There was, however, considerable heterogeneity between the results of the included studies. Our subgroup analyses did not identify any causes of heterogeneity among study results, but they did reveal confounding of the pooled result for postal versus electronic questionnaires. The unexplained heterogeneity means that we cannot be confident about the magnitude of the effects on response using postal rather than electronic questionnaires. However, from inspection of the forest plots we can be confident about the direction of these effects.
The evidence included in this review addresses ‘unit’ non-response only (i.e., return of questionnaires). ‘Item’ response (i.e., completion of individual questions) may be greater with electronic methods, but this was not addressed in this review and requires investigation in the future.
We assessed evidence for reporting bias using Harbord’s modified test for small-study effects and found no evidence for bias. This test may not be reliable given the substantial heterogeneity between the results of the included trials [ 55 ].
Due to the nature of this study (secondary analysis of a published review), there is no pre-registered protocol for the subgroup analyses provided in this study.
These results will help researchers and healthcare providers to improve data collection from study participants and patients, helping to maintain study power and reduce bias due to missing data in research studies. In addition to the methods already known to be effective in increasing questionnaire response [ 8 , 56 ], postal questionnaires should be used in preference to, or offered in addition to, electronic modes as this will help to increase the proportion of participants that responds. It should be noted, however, that the evidence upon which this recommendation is based is from studies published between 2001 and 2020, and this may change in the future as access to the Internet increases and more people become ‘tech-savvy’. Furthermore, we consider that the certainty of the evidence provided in this study is “Moderate”, due to the unexplained heterogeneity between the results of the included studies.
Evidence on effective data collection in low- and middle-income settings is needed. Research centres such as LSHTM can embed studies within trials (SWATs) in their research in these settings to help to increase the evidence base [ 57 ].
Participation rates for epidemiologic studies have been declining [ 58 ]. Our study has presented evidence that postal questionnaires are preferable to electronic questionnaires to improve participation, but it does not tell us why . Research is still needed to advance sociological and psychological theories of participation in data collection procedures [ 59 ].
Electronic administration provides benefits for researchers over paper administration which have not been addressed by this study: A well-designed Web questionnaire can control skip patterns, check for allowable values and ranges and response consistencies, and it can include instructions and explanations about why a question is being asked [ 60 ]. These options could help to improve the completeness and quality of self-administered data collection, maintaining study power, reducing the risk of bias in study results, and saving study resources. Further research into the cost-effectiveness of electronic administration compared with postal administration in different settings will be needed to inform practice [ 61 ].
Data extracted from included studies will be available in the forthcoming update on the Cochrane Library.
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Edwards, P., Perkins, C. Response is increased using postal rather than electronic questionnaires – new results from an updated Cochrane Systematic Review. BMC Med Res Methodol 24 , 209 (2024). https://doi.org/10.1186/s12874-024-02332-0
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Objectively measured physical activity and sedentary behaviour on cardiovascular risk and health-related quality of life in adults: a systematic review.
2. materials and methods, 2.1. search strategies, 2.2. eligibility criteria and selection of studies, 2.3. data extraction, 2.4. quality and risk of bias assessment, 3.1. data search, 3.2. characteristics of studies.
Author, Year, Country | Sample Size (n Total; n ♂/n ♀) | Age (Years) (Mean ± SD; Range) | Study Design | Sedentary Behaviour/Physical Activity Assessment | Health Related Quality of Life (HRQOL) Assessment | Cardiovascular Risk Assessment | Main Outcomes | Main Goals | Main Results | Quality and Risk of Bias Assessment |
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1. Marín-Jiménez et al. [ ] Spain Fitness League Against MENopause COst (FLAMENCO) project | 182 (182 ♀) | 52.6 ± 4.5 (45–60 y) | Cross-sectional study | Device: GT3X, Pensacola, FL; Days of wear: 9 days, but the first and the last was excluded from the analyses Minimum wear: Not applicable (N/A) Epochs: N/A Cut points: N/A Parameters evaluated: Sedentary time (ST), time in light, moderate, moderate-vigorous (MVPA), and vigorous physical activity (PA), total PA time per day and per week, bouted MVPA (period of 10 or more consecutive minutes (min) of duration in MVPA) and percentage of participants who met the international PA recommendations of at least 150 min of MVPA per week | Short-Form Health Survey 36 (SF-36) (score) | _________ | Weight, Height, body mass index (BMI), ST, PA and health-related quality of life (HRQoL) | To analyse the association of ST and PA with HRQoL in middle-aged women | Lower ST and greater light PA were associated with a better SF-36 emotional role (B: −0.03; 95% confidence interval (CI): −0.07 to −0.00; p = 0.02 and B: 0.04, 95% CI: 0.00–0.08; p = 0.01, respectively). Higher MVPA was associated with a better SF-36 physical function (B: 0.01, 95% CI: 0.00–0.02; p = 0.05) and SF-36 vitality (B: 0.02, 95% CI: 0.00–0.03; p = 0.01). Higher vigorous PA was associated with a better SF-36 physical function (B: 0.34, 95% CI: 0.0–0.66; p = 0.03), SF-36 bodily pain (B: 0.63, 95% CI: 0.02–1.25; p = 0.04), and the SF-36 physical component scale (B: 0.20, 95% CI: 0.00–0.39 p = 0.04). Higher total PA was associated with a better SF-36 emotional role (B: 0.03, 95% CI: 0.00–0.07: p = 0.02). | 9/12 (75%) |
2. Tigbe et al. [ ] United Kingdom | 111 (96 ♂/15 ♀) | 39 ± 8 ♂/42 ± 9 ♀ (22 to 60 y) | Cross-sectional study | Device: ActivPAL monitor; Days of wear: 7 consecutive days; Minimum wear: three 24-h periods, including a non-work day Epochs: N/A Cut points: N/A Parameters evaluated: time spent stepping, standing and sitting/lying as well as steps, mean stepping rate and number of sit-to-stand transitions per day. | ________ | PROCAM (score) Presence of the metabolic syndrome using the following specific criteria | PA, weight, height, waist circumference and CHD risk | To examined the associations between CHD risk and time spent in objectively- measured postures (sitting, lying and standing) and of stepping | Higher 10-year PROCAM risk was significantly (p < 0.05) associated with ST adjusting for age, sex, Scottish Index of Multiple Deprivation (SIMD), family history of CHD, job type and shift worked. | 7/12 (58.3%) |
3. Niemelä et al. [ ] Finland | 4582 (1916 ♂/2666 ♀) | (46–48 y) | Cross-sectional | Device: Polar Active, Polar Electro Oy, Kempele Finland; Days of wear: 14 days Minimum wear: 7 consecutive days with enough PA data (wear time ≥ 600 min/day), starting from the second measured day; Epochs: N/A Cut points: very light: 1–1.99 MET, light: 2–3.49 MET, moderate: 3.5–4.99 MET, vigorous: 5–7.99 MET, and vigorous+ ≥8 MET; MVPA was assessed as all activity at least 3.5 METs, while ST was assessed as the duration of very light activity Parameters evaluated: Daily averages of time spent in different activity levels; Total daily duration obtained in MVPA and ST bouts (at least 30 min of consecutive MET values between 1 and 2 METs). | ________ | Framingham risk model (percentage) | Height, weight, BMI, body fat percentage and visceral fat area, total cholesterol, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol levels, Systolic (SBP) and diastolic blood pressures (DBP), PA, CVD risk, | To identify temporal patterns of continuously measured physical activity beneficial for cardiovascular health in a middle-aged group using cluster analysis and to study how the widely used 10-year CVD risk model is associated with different PA profiles. | Significant differences in CVD risk between clusters were found both in men (p = 0.028) and women (p < 0.001). The inactive cluster had higher CVD risk compared with the very active cluster in men (p < 0.05). In women, the inactive cluster had higher CVD risk compared to moderately active and very active clusters, and the evening active cluster had higher risk compared to the moderately active cluster (p < 0.05). | 8/12 (66.7%) |
4. Kobayashi Frisk et al. [ ] Sweden | 812 (48% ♂/52% ♀) | 57.6 ± 4.4 (50–64 y) | Cross-sectional analysis | Device: ActiGraph GT3X and GT3X +, ActiGraph, LCC, Pensacola, FL, USA. Days of wear: 7 consecutive days Minimum wear: at least 600 min per day of wear time for at least 4 days Epochs: N/A Cut points: time spent sedentary (SED): 0–199 cpm, time spent in light intensity physical activity (LIPA): > 199 & < 2690 cpm, and time spend in moderate to vigorous intensity physical activity (MVPA): ≥ 2690 cpm Parameters evaluated: Daily percentage of SED and MVPA, total volume of physical activity (mean cpm of wear time), bout of SED (at least 20 min of consecutive cpm values <199 with no allowance for interruption above the threshold), bout of MVPA (10 min consecutive ≥ 2690 cpm, with an allowance of up to 2 min below this threshold), percentages of SED and MVPA in the morning (06:00 to 12:00), afternoon (12:00 to 18:00) and evening (18:00 to 00:00) | ________ | SCORE2 (score) | Chronotype, Mid-sleep time, Subjective sleep quality, Habitual sleep duration, PA, SED, Estimation of the 10-year risk of frst-onset CVD, | To investigate the relationship between chronotype, objectively measured physical activity patterns, and 10-year frst-onset CVD risk assessed by the Systematic Coronary Risk Evaluation 2 (SCORE2) | Extreme evening chronotypes exhibited the most sedentary lifestyle and least MVPA (55.3 ± 10.2 and 5.3 ± 2.9% of wear-time, respectively). Extreme evening chronotype was associated with increased SCORE2 risk compared to extreme morning type independent of confounders (β = 0.45, SE = 0.21, p = 0.031). SED was a significant mediator of the relationship between chronotype and SCORE2. | 8/12 (66.7%) |
5. Kolt et al. [ ] Australia WALK 2.0 randomised controlled trial | 504 (176 ♂/328 ♀) | 50.8 ±13.1 (18–65 y) | Cross-sectional | Device: ActiGraph GT3X activity monitor Days of wear: 7 consecutive days Minimum wear: 10 h of wear time on at least 5 days in the 7 day period. Epochs- 1 s Cut-points: MVPA—more than 1951 counts/min; Sedentary behaviour—less than 100 counts/min; Parameters evaluated: Daily measures of MVPA, sedentary behaviour, bouts (consecutive 10-min period) of MVPA, bouts of sedentary time and wear time. | 5-item ‘general health’ subscale of the RAND 36-Item Health Survey (RAND-36) (Score) | _________ | PA, Sedentary behaviour (SB), HRQoL | To examine the association of HRQoL with PA and sedentary behaviour, using both continuous duration (average daily minutes) and frequency measures (average daily number of bouts ≥10 min). | The duration measure (average daily minutes) of physical activity was positively related to general HRQoL (path coefficient = 0.294, p < 0.05) after adjusting for covariates of age, gender, BMI, level of education, and activity monitor wear time. In contrast, the physical activity bouts measure was negatively related to general HRQoL (path coefficient = −0.226, p < 0.05) after adjusting for covariates. The duration measure (average daily minutes) of sedentary behaviour was negatively related to general HRQoL (path coefficient = −0.217, p < 0.05) after adjusting for covariates of age, gender, BMI, level of education, and activity monitor wear time. | 8/12 (66.7%) |
4. discussion, 5. conclusions, author contributions, institutional review board statement, informed consent statement, data availability statement, acknowledgments, conflicts of interest.
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Santos, B.; Monteiro, D.; Silva, F.M.; Flores, G.; Bento, T.; Duarte-Mendes, P. Objectively Measured Physical Activity and Sedentary Behaviour on Cardiovascular Risk and Health-Related Quality of Life in Adults: A Systematic Review. Healthcare 2024 , 12 , 1866. https://doi.org/10.3390/healthcare12181866
Santos B, Monteiro D, Silva FM, Flores G, Bento T, Duarte-Mendes P. Objectively Measured Physical Activity and Sedentary Behaviour on Cardiovascular Risk and Health-Related Quality of Life in Adults: A Systematic Review. Healthcare . 2024; 12(18):1866. https://doi.org/10.3390/healthcare12181866
Santos, Beatriz, Diogo Monteiro, Fernanda M. Silva, Gonçalo Flores, Teresa Bento, and Pedro Duarte-Mendes. 2024. "Objectively Measured Physical Activity and Sedentary Behaviour on Cardiovascular Risk and Health-Related Quality of Life in Adults: A Systematic Review" Healthcare 12, no. 18: 1866. https://doi.org/10.3390/healthcare12181866
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Mario Alejandro Bravo-Ortiz is supported by a Ph.D. grant Convocatoria 22 OCAD de Ciencia, Tecnología e Innovación del Sistema General de Regalías de Colombia y Ministerio de Ciencia, Tecnología e Innovación de Colombia. We would like to thank Universidad Autónoma de Manizales for making this paper as part of the “Clasificación de los estadios del Alzheimer utilizando Imágenes de Resonancia Magnética Nuclear y datos clínicos a partir de técnicas de Deep Learning” with code 873-139 and "Aplicación de Vision Transformer para clasificar estadios del Alzheimer utilizando imágenes de resonancia magnética nuclear y datos clínicos" project with code 847-2023 TD. Additionally, we acknowledge the support from the projects ANID PIA/BASAL FB0002 and ANID/PIA/ANILLO ACT210096. We also extend our gratitude to Universidad de Caldas for their support, as this paper is part of the project “Plataforma tecnológica para la clasificación de los estadios de la enfermedad de alzheimer utilizando imágenes de resonancia magnética nuclear, datos clínicos y técnicas de deep learning.” with code PRY-89. We also thank the National Agency for Research and Development (ANID); Applied Research Subdirection (SIA); through the instrument IDeA I+D 2023, code ID23I10357, and ORIGEN 0011323, Sistema General de Regalías (SGR) - Asignación para la Ciencia, Tecnología e Innovación, project BPIN 2021000100368, and PRY-121 - Interactive Virtual Didactic Strategy for the Promotion of ICT Skills and their Relationship with Computational Thinking.
This work was funded by Universidad Autonoma de Manizales as part of the project “Clasificación de los estadios del Alzheimer utilizando Imágenes de Resonancia Magnética Nuclear y datos clínicos a partir de técnicas de Deep Learning” with code 873-139, and also by the projects “CH-T1246: Oportunidades de Mercado para las Empresas de Tecnología-Compras Públicas de Algoritmos Responsables, Éticos y Transparentes,” ANID PIA/BASAL FB0002, and ANID/PIA/ANILLOS ACT210096.
Mario Alejandro Bravo-Ortiz and Sergio Alejandro Holguin-Garcia have contributed equally to this work.
Departamento de Electrónica y Automatización, Universidad Autónoma de Manizales, Manizales, 170001, Caldas, Colombia
Mario Alejandro Bravo-Ortiz, Sergio Alejandro Holguin-Garcia, Sebastián Quiñones-Arredondo, Ernesto Guevara-Navarro, Harold Brayan Arteaga-Arteaga & Reinel Tabares-Soto
Departamento de Sistemas e Informática, Universidad de Caldas, Manizales, 170004, Caldas, Colombia
Mario Alejandro Bravo-Ortiz, Sergio Alejandro Holguin-Garcia, Ernesto Guevara-Navarro & Reinel Tabares-Soto
Facultad de Ingeniería y Ciencias, Universidad Adolfo Ibáñez, 7941169, Santiago, Chile
Gonzalo A. Ruz & Reinel Tabares-Soto
Center of Applied Ecology and Sustainability (CAPES), 8331150, Santiago, Chile
Gonzalo A. Ruz
Data Observatory Foundation, 7941169, Santiago, Chile
Unidad Mixta de Imagen Biomédica FISABIO-CIPF, Fundación para el Fomento de la Investigación Sanitario y Biomédica de la Comunidad Valenciana, 46020, Valencia, Spain
Alejandro Mora-Rubio
Centro de Bioinformática y Biología Computacional (BIOS), 170001, Manizales, Colombia
Mario Alejandro Bravo-Ortiz & Sergio Alejandro Holguin-Garcia
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MABO contributed to Conceptualization, Methodology, Investigation, Writing—original draft, Writing—review and editing. SAHG contributed to Conceptualization, Methodology, Investigation, Writing—original draft, Writing—review and editing. SQA contributed to Writing—review and editing. EGN contributed to Writing—review and editing. AMR: Writing—review and editing. HBAA contributed to Writing—review and editing. GAR: Writing—review and editing, acquired the funding and provided the resources. RTS contributed to Writing—review and editing, acquired the funding and provided the resources.
Correspondence to Mario Alejandro Bravo-Ortiz .
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Bravo-Ortiz, M.A., Holguin-Garcia, S.A., Quiñones-Arredondo, S. et al. A systematic review of vision transformers and convolutional neural networks for Alzheimer’s disease classification using 3D MRI images. Neural Comput & Applic (2024). https://doi.org/10.1007/s00521-024-10420-x
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DOI : https://doi.org/10.1007/s00521-024-10420-x
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Formulating a research question takes time and your team may go through different versions until settling on the right research question. A research question framework can help structure your systematic review question. PICO/T is an acronym which stands for. P Population/Problem; I Intervention/Exposure; C Comparison; O Outcome
There are three different sorts of PICOs within Cochrane Reviews. PICO stands for four different potential components of a health question used in Cochrane Review research: Patient, Population or Problem; Intervention; Comparison; Outcome. These components give you the specific who, what, when, where and how, of an evidence-based health-care research question.
In Chapter 2, Section 2.3, we introduced the ideas of a review PICO (on which eligibility of studies ... The chosen subset of comparisons should address the most important clinical and research questions. For example, if an established intervention (or dose of an intervention) is used in practice, then the synthesis would ideally compare novel ...
Your systematic review or systematic literature review will be defined by your research question. A well formulated question will help: Frame your entire research process. Determine the scope of your review. Provide a focus for your searches. Help you identify key concepts. Guide the selection of your papers.
The PICO model is also frequently used as a tool for structuring clinical research questions in connection with evidence syntheses (e.g., systematic reviews). The Cochrane Handbook for Systematic Reviews of Interventions specifies using PICO as a model for developing a review question, thus ensuring that the relevant components of the question ...
A systematic review aims to answer a specific research (clinical) question. A well-formulated question will guide many aspects of the review process, including determining eligibility criteria, searching for studies, collecting data from included studies, and presenting findings (Cochrane Handbook, Sec. 5.1.1).To define a researchable question, the most commonly used structure is PICO, which ...
Research topic vs review question. A research topic is the area of study you are researching, and the review question is the straightforward, focused question that your systematic review will attempt to answer.. Developing a suitable review question from a research topic can take some time. You should: perform some scoping searches; use a framework such as PICO
Systematic reviews require focused clinical questions. PICO is a useful tool for formulating such questions. For information on PICO and other frameworks please see our tutorial below. The PICO (Patient, Intervention, Comparison, Outcome) framework is commonly used to develop focused clinical questions for quantitative systematic reviews.
Use the PICO framework to translate the research question into search concepts that can be applied in a structured search strategy. In general, you should not use all parts of the PICO question in the search. The key focus of the search would be generally on the P (Population / Patient / Problem) and the I (Intervention), and sometimes C ...
This video illustrates how to use the PICO framework to formulate an effective research question, and it also shows how to search a database using the search terms identified. ... Having a focused and specific research question is especially important when undertaking a systematic review. If your search question is too broad you will retrieve ...
Depending on the scope of the review, authors should decide if it is more beneficial to lump things together resulting in a broader PICO question or if it is more useful to split comparisons and create narrow PICO questions. 2 To define the scope of the review, research priorities should be identified, and stakeholders should be engaged. The ...
The literature search forms the underlying basis of systematic reviews and thus the quality of the literature search is of crucial importance to the overall quality of the systematic review [].The use of the four-part PICO model to facilitate searching for a precise answer is recommended [] stating that a clinical question must be focused and well-articulated for all four parts: the patient or ...
On the Systematic Review Request form you will be asked to outline your research question in PICO format. This allows us to easily understand the main concepts of your research question. Here is what PICO stands for: P = Problem/Population. I = Intervention (or the experimental variable) C = Comparison (or the control variable) [Optional] O ...
Framing a Research Question in a PICO Framework Systematic Review. In systematic reviews and meta-analyses, the PICO framework is commonly used to frame a research question. To do so, you must start by defining the PICO elements. In most cases, the population of interest is known by a clinician or researcher. The intervention may be known or ...
A technique often used in research for formulating a clinical research question is the PICO model. Slightly different versions of this concept are used to search for quantitative and qualitative reviews. The PICO/ PECO framework is an adaptable approach to help you focus your research question and guide you in developing search terms. The ...
"To benefit patients and clinicians, such questions need to be both directly relevant to patients' problems and phrased in ways that direct your search to relevant and precise answers." - CEBM, University of Toronto, Asking Focused Questions. The PICO model is a tool that can help you formulate a good clinical question.
1. Introduction. The literature search forms the underlying basis of systematic reviews and thus the quality of the literature search is of crucial importance to the overall quality of the systematic review [1].The use of the four-part PICO model to facilitate searching for a precise answer is recommended [2] stating that a clinical question must be focused and well-articulated for all four ...
Covidence covers five key steps to formulate your review question using PICO. You've decided to go ahead. You have identified a gap in the evidence and you know that conducting a systematic review, with its explicit methods and replicable search, is the best way to fill it - great choice . The review will produce useful information to ...
Systematic reviews address clear and answerable research questions, rather than a general topic or problem of interest. ... Research question: What are the views and experiences of UK healthcare workers regarding vaccination for seasonal influenza? ... PICO Population - Intervention- Outcome- Comparison. Variations: add T on for time, or ...
A systematic review question A scoping review question; Typically a focused research question with narrow parameters, and usually fits into the PICO question format: ... (can be copied and pasted into the Embase search box then combined with the concepts of your research question): (exp review/ or (literature adj3 review$).ti,ab. or exp meta ...
This article will assist researchers by providing step-by-step guidance on the formulation of a research question. This paper also describes PICO (population, intervention, control, and outcomes) criteria in framing a research question. Finally, we also assess the characteristics of a research question in the context of initiating a research ...
PICO Framework. The first step in performing a Systematic Review is to formulate the research question. Without a well-focused question, it can be very difficult and time consuming to identify appropriate resources and search for relevant evidence. Practitioners of Evidence-Based Practice (EBP) often use a specialised framework, called PICO, to ...
Background. Systematic reviews are a crucial method, underpinning evidence based practice and informing health care decisions [1,2].Traditionally systematic reviews are completed using an objective and primarily quantitative approach [] whereby a comprehensive search is conducted, attempting to identify all relevant articles which are then integrated and assimilated through statistical analysis.
Introduction. On July 13, 2022, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Novavax COVID-19 (NVX-CoV2373) vaccine for prevention of symptomatic COVID-19 for persons aged ≥18 years. 4 As part of the process employed by the ACIP, a systematic review and GRADE evaluation of the evidence for Novavax COVID-19 vaccine was conducted and presented to ...
Inclusion and exclusion criteria. All studies evaluating the PEC e-SUS APS will be considered for the inclusion criteria. Given the myriad aspects of electronic health record systems open to analysis (e.g., user experience, usability, efficiency, accessibility, security, and economic aspects), this review will include studies evaluating the general function and effectiveness of the PEC e-SUS ...
Data sources/measurement. We exported data of randomised controlled trials included in the updated Cochrane Review [] from RevMan and imported them into Stata for a series of meta-analyses not conducted in the Cochrane review.Comparisons. We focused on data from trials included in three comparisons in the Cochrane Review that had evaluated hypotheses relevant to our research objective:
A systematic review was performed on all publications concerning the recurrence of OL after various surgical treatments following the Preferred Reported Items for Systematic Reviews and Meta-Analyses guidelines. The PICO criteria for study selection were as follows: P, patients with oral leukoplakia; I, surgical treatment; C, different surgical ...
Background: This systematic review analysed the association between objectively measured physical activity and sedentary behaviour with cardiovascular risk and HRQoL in adults without previous CVD. Additionally, we analysed the impact of the intensity of the physical activity in this association. Methods: The search was carried out in three electronic databases with access until February 2023 ...
A Systematic Scoping Review. Using the framework developed by Arksey and O'Malley (), a systematic scoping review methodology was used to identify the available research literature on the disclosure of child sexual abuse.To clarify the use of the term 'systematic' in the context of a scoping review, we adopted a methodologically sound process for searching the literature to scope the ...
2.2 Research questions. This systematic review, structured around the PRISMA (see Fig. 4) (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, evaluated the diagnostic performance of CNNs and ViTs in detecting and classifying AD. Although previous studies have shown that both CNNs and ViTs outperform traditional ...