8. Patient and public involvement

What to write

Details of patient or public involvement in the design, conduct, and reporting of the trial

Examples

“A study patient advisory group advised on study design before funding, in study set-up, and during recruitment. They chose the term best current treatment and informed the design of clinic procedures (including how best to reduce the burden of intervention), questionnaire design, and participant information. This group informed protocol modifications in response to low recruitment, and guided interpretation of the findings. Two public contributors were members of the independent trial steering committee.”1

“The UK Musculoskeletal Trauma Patient and Public Involvement (PPI) Group co-designed this study. In particular, the group advised on the choice of outcome measures and the follow-up arrangements, which were designed to limit the number of face-to-face hospital visits needed. Subsequently, a patient member from this group became a member of the DRAFFT2 Trial Management Group, overseeing all elements of the set-up and delivery of the trial and the dissemination of the lay summary at completion. Another patient member of the group was also a member of the independent Trial Steering Committee.”2

“Office workers, workplace champions, and managers within the target organisation were involved in the study design during the grant application process and the study delivery phase. During the grant application phase, the purpose and design of the study as well as the suggested intervention strategies were presented to two large groups of council employees. As a result of these meetings, the study design included using finger prick blood testing rather than taking venous blood samples, participants receiving feedback on health measures, and incentives for attending follow-up. During the study set-up and delivery, a council employee advisory group met several times and provided advice on delivery of the interventions (feedback showed that workplace champions would not be comfortable delivering the initial education session because of the training and planning time required, so this session was delivered online instead), recruitment processes (feedback was provided on participant documents and recruitment messages and strategies within the council), installation of the height adjustable desk, and troubleshooting. Two council employees were also part of the trial steering committee, which met twice a year during the study”.3

“In the context of the pandemic and the need to design the study in a short period, no patients were involved in setting the research questions or the outcome measures, nor were they involved in developing plans for recruitment, design, or implementation of the study. No patients were asked to advise on interpretation or writing up of results.”4

Explanation

Patient and public involvement (PPI) has been shown to be particularly beneficial in clinical trials.5 It can help researchers to identify and prioritise research topics and questions; identify relevant outcome measures; boost recruitment and retention; improve trial design and tools; and improve the acceptability of trials.5,6 PPI can also improve the communication and dissemination of the trial results to participants. Public involvement in other types of health research has been shown to help researchers to engage under-served populations and recruit diverse participant groups.5 Thus, transparent reporting of PPI is essential to allow readers to appraise the relevance and usefulness of findings to end users and to fully evaluate and understand a trial’s methodology and conduct. If patients and the public were not involved, authors should report this with the reasons why.

PPI in health research entails collaborating or partnering with patients and members of the public to design, conduct, report, interpret, or disseminate research: the research is done by or with patients and the public—rather than done for, at, or about them.7,89 Importantly, this is distinct from including patients or members of the public in a trial as participants. PPI contributors can be people with current or past experience of a health condition; their families, carers, and advocates; members of communities who are target users of an intervention or service; or members of the wider public with a broader perspective. The terminology used differs internationally: for example, such activity is most commonly known as “patient and public involvement” in the UK, whereas “patient engagement” is more common in mainland Europe and North America,8,9, “community and public engagement” is commonly used in part of Africa, and “consumer involvement” is frequently used in Australia.10

The GRIPP (Guidance for Reporting Involvement of Patients and Public) checklist was developed in 2011 with the aim of improving the reporting of PPI activities in health research11; followed in 2017 by GRIPP2.12 The GRIPP2 checklist includes GRIPP2-SF, which is a short form of the GRIPP2 checklist where PPI is the secondary focus of the research.12 Examples of reporting of PPI involvement could include whether and how patients were involved in the trial objectives, whether patients advised on optimising patient recruitment and retention, and whether and how patients were included in selection of the trial outcomes.

Funding bodies are increasingly encouraging or requiring researchers to include PPI in grant applications,7,13,14 but mandating of PPI reporting by journals has remained uncommon. In 2014, The BMJ introduced a requirement for submitted manuscripts to include a PPI statement,15 and this was extended to other BMJ journals from 2018.16,17 A 2023 study of trials addressing chronic conditions found that approximately 80% of trial reports published in these journals included a PPI subsection, and around 40% of these reported that PPI activities had been conducted.18 Few other journals have followed suit in mandating reporting of PPI activities.1921 In the absence of an explicit requirement, reporting of PPI activities remains infrequent, appearing in an estimated 0-5% of published trial reports.2224 There is limited evidence to indicate the extent to which this reflects a lack of PPI activity versus PPI activity being conducted but not reported. In a small survey of authors of trials published in high impact factor journals, only one of 29 respondents reported PPI activities having been included but not mentioned in the published article24; while in a survey of authors of pragmatic trials, 47% reported including PPI activities during a trial but less than a quarter of these reported the activity in the corresponding publication.25

Training

The UK EQUATOR Centre runs training on how to write using reporting guidelines.

Discuss this item

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References

1.
Paskins Z, Bromley K, Lewis M, et al. Clinical effectiveness of one ultrasound guided intra-articular corticosteroid and local anaesthetic injection in addition to advice and education for hip osteoarthritis (HIT trial): Single blind, parallel group, three arm, randomised controlled trial. BMJ. Published online April 2022:e068446. doi:10.1136/bmj-2021-068446
2.
Costa ML, Achten J, Ooms A, et al. Surgical fixation with k-wires versus casting in adults with fracture of distal radius: DRAFFT2 multicentre randomised clinical trial. BMJ. Published online January 2022:e068041. doi:10.1136/bmj-2021-068041
3.
Edwardson CL, Biddle SJH, Clemes SA, et al. Effectiveness of an intervention for reducing sitting time and improving health in office workers: Three arm cluster randomised controlled trial. BMJ. Published online August 2022:e069288. doi:10.1136/bmj-2021-069288
4.
BMJ. Published online January 2022:e068407. doi:10.1136/bmj-2021-068407
5.
Staley k. Exploring impact: Public involvement in NHS, public health and social care research. INVOLVE, eastleigh. Https://wellcomecollection.org/works/wtbmggvr. 2009.
6.
Price A, Albarqouni L, Kirkpatrick J, et al. Patient and public involvement in the design of clinical trials: An overview of systematic reviews. Journal of Evaluation in Clinical Practice. 2017;24(1):240-253. doi:10.1111/jep.12805
7.
National institute for health and care research. Briefing notes for researchers - public involvement in NHS, health and social care research (version 1.0) [accessed 11 sept 2023] 2021.
8.
Forsythe LP, Carman KL, Szydlowski V, et al. Patient engagement in research: Early findings from the patient-centered outcomes research institute. Health Affairs. 2019;38(3):359-367. doi:10.1377/hlthaff.2018.05067
9.
Vanderhout S, Nicholls S, Monfaredi Z, et al. Facilitating and supporting the engagement of patients, families and caregivers in research: The “ottawa model” for patient engagement in research. Research Involvement and Engagement. 2022;8(1). doi:10.1186/s40900-022-00350-0
10.
NHMRC. Guidelines for guidelines: Consumer involvement. Https://www.nhmrc.gov.au/guidelinesforguidelines/plan/consumer-involvement. 2018. [Accessed 11 sept 2023].
11.
Staniszewska S, Brett J, Mockford C, Barber R. The GRIPP checklist: Strengthening the quality of patient and public involvement reporting in research. International Journal of Technology Assessment in Health Care. 2011;27(4):391-399. doi:10.1017/s0266462311000481
12.
Staniszewska S, Brett J, Simera I, et al. GRIPP2 reporting checklists: Tools to improve reporting of patient and public involvement in research. BMJ. Published online August 2017:j3453. doi:10.1136/bmj.j3453
13.
NHMRC. Statement on consumer and community involvement in health and medical research. Https://www.nhmrc.gov.au/sites/default/files/documents/reports/consumer-community-involvement.pdf [accessed 09 sept 2023]: Consumers health forum of australia; 2016.
14.
CIHR-IRSC. Strategy for patient-oriented research patient engagement framework. 2019. Https://cihr-irsc.gc.ca/e/documents/spor_framework-en.pdf [accessed 09 sept 2023].
15.
Richards T, Godlee F. The BMJ’s own patient journey. BMJ. 2014;348(jun10 4):g3726-g3726. doi:10.1136/bmj.g3726
16.
BMJ. New requirements for patient and public involvement statements in BMJ open. 2018. Https://blogs.bmj.com/bmjopen/2018/03/23/new-requirements-for-patient-and-public-involvement-statements-in-bmj-open/ [accessed 09 sept 2023].
17.
BMJ. BMJ author hub: Patient and public partnership. Https://authors.bmj.com/policies/patient-public-partnership/ [accessed 11 sept 2023] [.
18.
Husson M, Dechartres A, Ramdjee B, et al. Patient and public involvement is suboptimal in randomized controlled trials addressing a chronic condition. Journal of Clinical Epidemiology. 2023;160:71-82. doi:10.1016/j.jclinepi.2023.06.012
19.
Iongh A de, Severwright A, Taylor J. Patient and public involvement statements in british journal of occupational therapy: An important step. British Journal of Occupational Therapy. 2021;84(8):459-460. doi:10.1177/03080226211030103
20.
Research involvement and engagement: Preparing your manuscript. Https://researchinvolvement.biomedcentral.com/submission-guidelines/preparing-your-manuscript/research [accessed 2023-10-19].
21.
Davis S, Pinfold V, Catchpole J, Lovelock C, Senthi B, Kenny A. Reporting lived experience work. The Lancet Psychiatry. 2024;11(1):8-9. doi:10.1016/s2215-0366(23)00402-9
22.
Gray R, Brasier C, Zirnsak TM, Ng AH. Reporting of patient and public involvement and engagement (PPIE) in clinical trials published in nursing science journals: A descriptive study. Research Involvement and Engagement. 2021;7(1). doi:10.1186/s40900-021-00331-9
23.
Patel VA, Shelswell J, Hillyard N, Pavitt S, Barber SK. A study of the reporting of patient and public involvement and engagement (PPIE) in orthodontic research. Journal of Orthodontics. 2020;48(1):42-51. doi:10.1177/1465312520968574
24.
Benizri N, Hallot S, Burns K, Goldfarb M. Patient and family representation in randomized clinical trials published in 3 medical and surgical journals: A systematic review. JAMA Network Open. 2022;5(9):e2230858. doi:10.1001/jamanetworkopen.2022.30858
25.
Vanderhout S, Nevins P, Nicholls SG, et al. Patient and public involvement in pragmatic trials: Online survey of corresponding authors of published trials. CMAJ Open. 2023;11(5):E826-E837. doi:10.9778/cmajo.20220198

Reuse

Most of the reporting guidelines and checklists on this website were originally published under permissive licenses that allowed their reuse. Some were published with propriety licenses, where copyright is held by the publisher and/or original authors. The original content of the reporting checklists and explanation pages on this website were drawn from these publications with knowledge and permission from the reporting guideline authors, and subsequently revised in response to feedback and evidence from research as part of an ongoing scholarly dialogue about how best to disseminate reporting guidance. The UK EQUATOR Centre makes no copyright claims over reporting guideline content. Our use of copyrighted content on this website falls under fair use guidelines.

Citation

For attribution, please cite this work as:
Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ. 2025;389:e081123. doi:10.1136/bmj-2024-081123

Reporting Guidelines are recommendations to help describe your work clearly

Your research will be used by people from different disciplines and backgrounds for decades to come. Reporting guidelines list the information you should describe so that everyone can understand, replicate, and synthesise your work.

Reporting guidelines do not prescribe how research should be designed or conducted. Rather, they help authors transparently describe what they did, why they did it, and what they found.

Reporting guidelines make writing research easier, and transparent research leads to better patient outcomes.

Easier writing

Following guidance makes writing easier and quicker.

Smoother publishing

Many journals require completed reporting checklists at submission.

Maximum impact

From nobel prizes to null results, articles have more impact when everyone can use them.

Who reads research?

You work will be read by different people, for different reasons, around the world, and for decades to come. Reporting guidelines help you consider all of your potential audiences. For example, your research may be read by researchers from different fields, by clinicians, patients, evidence synthesisers, peer reviewers, or editors. Your readers will need information to understand, to replicate, apply, appraise, synthesise, and use your work.

Cohort studies

A cohort study is an observational study in which a group of people with a particular exposure (e.g. a putative risk factor or protective factor) and a group of people without this exposure are followed over time. The outcomes of the people in the exposed group are compared to the outcomes of the people in the unexposed group to see if the exposure is associated with particular outcomes (e.g. getting cancer or length of life).

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Case-control studies

A case-control study is a research method used in healthcare to investigate potential risk factors for a specific disease. It involves comparing individuals who have been diagnosed with the disease (cases) to those who have not (controls). By analysing the differences between the two groups, researchers can identify factors that may contribute to the development of the disease.

An example would be when researchers conducted a case-control study examining whether exposure to diesel exhaust particles increases the risk of respiratory disease in underground miners. Cases included miners diagnosed with respiratory disease, while controls were miners without respiratory disease. Participants' past occupational exposures to diesel exhaust particles were evaluated to compare exposure rates between cases and controls.

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Cross-sectional studies

A cross-sectional study (also sometimes called a "cross-sectional survey") serves as an observational tool, where researchers capture data from a cohort of participants at a singular point. This approach provides a 'snapshot'— a brief glimpse into the characteristics or outcomes prevalent within a designated population at that precise point in time. The primary aim here is not to track changes or developments over an extended period but to assess and quantify the current situation regarding specific variables or conditions. Such a methodology is instrumental in identifying patterns or correlations among various factors within the population, providing a basis for further, more detailed investigation.

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Systematic reviews

A systematic review is a comprehensive approach designed to identify, evaluate, and synthesise all available evidence relevant to a specific research question. In essence, it collects all possible studies related to a given topic and design, and reviews and analyses their results.

The process involves a highly sensitive search strategy to ensure that as much pertinent information as possible is gathered. Once collected, this evidence is often critically appraised to assess its quality and relevance, ensuring that conclusions drawn are based on robust data. Systematic reviews often involve defining inclusion and exclusion criteria, which help to focus the analysis on the most relevant studies, ultimately synthesising the findings into a coherent narrative or statistical synthesis. Some systematic reviews will include a [meta-analysis]{.defined data-bs-toggle="offcanvas" href="#glossaryItemmeta_analyses" aria-controls="offcanvasExample" role="button"}.

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Systematic review protocols

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Meta analyses of Observational Studies

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Randomised Trials

A randomised controlled trial (RCT) is a trial in which participants are randomly assigned to one of two or more groups: the experimental group or groups receive the intervention or interventions being tested; the comparison group (control group) receive usual care or no treatment or a placebo. The groups are then followed up to see if there are any differences between the results. This helps in assessing the effectiveness of the intervention.

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Randomised Trial Protocols

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Qualitative research

Research that aims to gather and analyse non-numerical (descriptive) data in order to gain an understanding of individuals' social reality, including understanding their attitudes, beliefs, and motivation. This type of research typically involves in-depth interviews, focus groups, or field observations in order to collect data that is rich in detail and context. Qualitative research is often used to explore complex phenomena or to gain insight into people's experiences and perspectives on a particular topic. It is particularly useful when researchers want to understand the meaning that people attach to their experiences or when they want to uncover the underlying reasons for people's behaviour. Qualitative methods include ethnography, grounded theory, discourse analysis, and interpretative phenomenological analysis.

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Case Reports

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Diagnostic Test Accuracy Studies

Diagnostic accuracy studies focus on estimating the ability of the test(s) to correctly identify people with a predefined target condition, or the condition of interest (sensitivity) as well as to clearly identify those without the condition (specificity).

Prediction Models

Prediction model research is used to test the accurarcy of a model or test in estimating an outcome value or risk. Most models estimate the probability of the presence of a particular health condition (diagnostic) or whether a particular outcome will occur in the future (prognostic). Prediction models are used to support clinical decision making, such as whether to refer patients for further testing, monitor disease deterioration or treatment effects, or initiate treatment or lifestyle changes. Examples of well known prediction models include EuroSCORE II for cardiac surgery, the Gail model for breast cancer, the Framingham risk score for cardiovascular disease, IMPACT for traumatic brain injury, and FRAX for osteoporotic and hip fractures.

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Animal Research

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Quality Improvement in Healthcare

Quality improvement research is about finding out how to improve and make changes in the most effective way. It is about systematically and rigourously exploring "what works" to improve quality in healthcare and the best ways to measure and disseminate this to ensure positive change. Most quality improvement effectiveness research is conducted in hospital settings, is focused on multiple quality improvement interventions, and uses process measures as outcomes. There is a great deal of variation in the research designs used to examine quality improvement effectiveness.

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Economic Evaluations in Healthcare

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Meta Analyses

A meta-analysis is a statistical technique that amalgamates data from multiple studies to yield a single estimate of the effect size. This approach enhances precision and offers a more comprehensive understanding by integrating quantitative findings. Central to a meta-analysis is the evaluation of heterogeneity, which examines variations in study outcomes to ensure that differences in populations, interventions, or methodologies do not skew results. Techniques such as meta-regression or subgroup analysis are frequently employed to explore how various factors might influence the outcomes. This method is particularly effective when aiming to quantify the effect size, odds ratio, or risk ratio, providing a clearer numerical estimate that can significantly inform clinical or policy decisions.

How Meta-analyses and Systematic Reviews Work Together

Systematic reviews and meta-analyses function together, each complementing the other to provide a more robust understanding of research evidence. A systematic review meticulously gathers and evaluates all pertinent studies, establishing a solid foundation of qualitative and quantitative data. Within this framework, if the collected data exhibit sufficient homogeneity, a meta-analysis can be performed. This statistical synthesis allows for the integration of quantitative results from individual studies, producing a unified estimate of effect size. Techniques such as meta-regression or subgroup analysis may further refine these findings, elucidating how different variables impact the overall outcome. By combining these methodologies, researchers can achieve both a comprehensive narrative synthesis and a precise quantitative measure, enhancing the reliability and applicability of their conclusions. This integrated approach ensures that the findings are not only well-rounded but also statistically robust, providing greater confidence in the evidence base.

Why Don't All Systematic Reviews Use a Meta-Analysis?

Systematic reviews do not always have meta-analyses, due to variations in the data. For a meta-analysis to be viable, the data from different studies must be sufficiently similar, or homogeneous, in terms of design, population, and interventions. When the data shows significant heterogeneity, meaning there are considerable differences among the studies, combining them could lead to skewed or misleading conclusions. Furthermore, the quality of the included studies is critical; if the studies are of low methodological quality, merging their results could obscure true effects rather than explain them.

Protocol

A plan or set of steps that defines how something will be done. Before carrying out a research study, for example, the research protocol sets out what question is to be answered and how information will be collected and analysed.

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