A systematic review to identify and collate factors influencing patient journeys through clinical trials
Open accessAbstract
Summary Patient-centred trial design and delivery; improves recruitment and retention; increases participant satisfaction; encourages participation by a more representative cohort; and allows researchers to better meet participants’ needs. Research in this area mostly focusses on narrow facets of trial participation. We aimed to systematically identify the breadth of patient-centred factors influencing participation and engagement in trials, and collate them into a framework. Through this we hoped to assist researchers to identify factors that could improve patient-centred trial design and delivery. Robust qualitative and mixed methods systematic reviews are becoming increasingly common in health research. The protocol for this review was prospectively registered on PROSPERO, CRD42020184886. We used the SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, Research Type) framework as a standardised systematic search strategy tool. 3 databases were searched as well as references checking, and thematic synthesis was conducted. Screening agreement was performed and code and theme checking were conducted by 2 independent researchers. Data were drawn from 285 peer-reviewed articles. 300 discrete factors were identified, and sorted into 13 themes and subthemes. The full catalogue of factors is included in the Supplementary Material . A summary framework is included in the body of the article. This paper focusses on outlining common ground that themes share, highlighting critical features, and exploring interesting points from the data. Through this, we hope researchers from multiple specialities may be better able to meet patients’ needs, protect patients’ psychosocial wellbeing, and optimise trial recruitment and retention, with direct positive impact on research time and cost efficiency.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Surveys have shown that a potential barrier to trial participation is the possibility of being allocated a placebo only or active comparator intervention that is perceived to be less desirable than the study intervention.
“In addition, surveys have shown that a potential barrier to trial participation is the possibility of being allocated a placebo only or active comparator intervention that is perceived to be less desirable than the study intervention.140”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [140]
Information about background is particularly important to trial participants as it provides motivation for contributing to the trial.
“This information is particularly important to the trial participants as it provides motivation for contributing to the trial.140”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [140]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Using thematic analysis in psychology
Braun, V., & Clarke, V. (2006) · Qualitative Research in Psychology · doi:10.1191/1478088706qp063oa · Cited by 194,414 · see citing works
Frailty: implications for clinical practice and public health
Hoogendijk, E. O., Afilalo, J., Ensrud, K. E., Kowal, P. R., Onder, G., & Fried, L. P. (2019) · The Lancet · doi:10.1016/s0140-6736(19)31786-6 · Cited by 3,369 · see citing works
Participation in Cancer Clinical Trials: Race-, Sex-, and Age-Based Disparities
Murthy, V. H., Krumholz, H. M., & Gross, C. P. (2004) · JAMA · doi:10.1001/jama.291.22.2720 · Cited by 2,078 · see citing works
Developing the Review Question and Inclusion Criteria
Stern, C., Jordan, Z., & McArthur, A. (2014) · AJN, American Journal of Nursing · doi:10.1097/01.naj.0000445689.67800.86 · Cited by 629 · see citing works
Campbell, M., Snowdon, C., Francis, D., Elbourne, D., McDonald, A., Knight, R., Entwistle, V, Garcia, J., Roberts, I., Grant, A., et al. (2007) · Health Technology Assessment · doi:10.3310/hta11480 · Cited by 433 · see citing works
Prevalence, Characteristics, and Publication of Discontinued Randomized Trials
Kasenda, B., von Elm, E. B., You, J. J., Blümle, A., Tomonaga, Y., Saccilotto, R. T., Amstutz, A., Bengough, T., Meerpohl, J. J., Stegert, M., et al. (2014) · JAMA · doi:10.1001/jama.2014.1361 · Cited by 416 · see citing works
Stryker, J. E., Wray, R. J., Emmons, K. M., Winer, E. P., & Demetri, G. D. (2005) · Patient Education and Counseling · doi:10.1016/j.pec.2005.09.006 · Cited by 136 · see citing works
Identifying the factors affecting ‘patient engagement’ in exercise rehabilitation
Teo, J. L., Zheng, Z., & Bird, S. R. (2022) · BMC Sports Science, Medicine and Rehabilitation · doi:10.1186/s13102-022-00407-3 · Cited by 96 · see citing works
Barnett, J., Aguilar, S., Brittner, M. R., & Bonuck, K. A. (2012) · Contemporary Clinical Trials · doi:10.1016/j.cct.2012.06.005 · Cited by 87 · see citing works
Parra-Medina, D. M., D'Antonio, A. M., Smith, S. M. R., Levin, S., Kirkner, G. J., & Mayer‐Davis, E. J. (2004) · Journal of the American Dietetic Association · doi:10.1016/j.jada.2003.10.014 · Cited by 87 · see citing works
Why do people cooperate with medical research? Findings from three studies
Dixon‐Woods, M., & Tarrant, C. (2009) · Social Science & Medicine · doi:10.1016/j.socscimed.2009.03.034 · Cited by 75 · see citing works
Boakye, E. A., Varble, A., Rojek, R. P., Peavler, O., Trainer, A. K., Osazuwa‐Peters, N., & Hinyard, L. (2018) · Public Health Reports · doi:10.1177/0033354918794935 · Cited by 63 · see citing works
Patient satisfaction with clinical trial participation
Verheggen, F. W. S. M., Nieman, F. H. M., Reerink, E., et al. (1998) · International Journal for Quality in Health Care · doi:10.1093/intqhc/10.4.319 · Cited by 60 · see citing works
Furimsky, I., Cheung, A. H., Dewa, C. S., & Zipursky, R. B. (2008) · Contemporary Clinical Trials · doi:10.1016/j.cct.2008.07.005 · Cited by 57 · see citing works
"I Had Already Made Up My Mind"
Shannon‐Dorcy, K., & Drevdahl, D. J. (2011) · Cancer Nursing · doi:10.1097/ncc.0b013e318207cb03 · Cited by 40 · see citing works
Racial Differences Among Factors Associated with Participation in Clinical Research Trials
Kurt, A., Semler, L., Jacoby, J. L., Johnson, M. B., Careyva, B. A., Stello, B., Friel, T. J., Knouse, M. C., Kincaid, H. M., & Smulian, J. C. (2016) · Journal of Racial and Ethnic Health Disparities · doi:10.1007/s40615-016-0285-1 · Cited by 38 · see citing works
Is Taking Part in Clinical Trials Good for your Health? A Cohort Study
Clark, A. L., Lammiman, M. J., Goode, K. M., & Cleland, J. G. F. (2009) · European Journal of Heart Failure · doi:10.1093/eurjhf/hfp133 · Cited by 28 · see citing works
Briel, M., Elger, B. S., von Elm, E. B., & Satalkar, P. P. (2017) · Swiss Medical Weekly · doi:10.4414/smw.2017.14556 · Cited by 26 · see citing works
Impact of Race, Age, and Socioeconomic Status on Participation in Pancreatic Cancer Clinical Trials
El‐Rayes, B. F., Jasti, P., Severson, R. K., et al. (2010) · Pancreas · doi:10.1097/mpa.0b013e3181da91dd · Cited by 24 · see citing works
Motivators for Alzheimer’s disease clinical trial participation
Bardach, S. H., Holmes, S., & Jicha, G. A. (2017) · Aging Clinical and Experimental Research · doi:10.1007/s40520-017-0771-2 · Cited by 21 · see citing works
The patient's experience of being a human subject
Kerrison, S., Laws, S., Cane, M., & Thompson, A. J. (2008) · Journal of the Royal Society of Medicine · doi:10.1258/jrsm.2007.070288 · Cited by 12 · see citing works
Dobra, R., Scott, S. F., Davies, J. C., et al. (2019) · Journal of Cystic Fibrosis · doi:10.1016/j.jcf.2019.04.008 · Cited by 11 · see citing works
Self-citationDobra, R., Davies, G. A., Pike, K. C., et al. (2021) · Journal of Cystic Fibrosis · doi:10.1016/j.jcf.2021.03.027 · Cited by 8 · see citing works
Self-citationLægreid, I. K., Aasarød, K., & Jordhøy, M. (2011) · Scandinavian Journal of Urology and Nephrology · doi:10.3109/00365599.2011.568957 · Cited by 7 · see citing works
Dillard, J. P., Meyer, B. J. F., Solomon, D. H., et al. (2015) · Patient Education and Counseling · doi:10.1016/j.pec.2015.01.007 · Cited by 4 · see citing works
“Fortunate are those who take the first steps”? The psychosocial impact of novel drug development
Dobra, R., Madge, S. L., Martin, I., et al. (2019) · Paediatric Respiratory Reviews · doi:10.1016/j.prrv.2019.02.005 · Cited by 4 · see citing works
Self-citation
Flagged first, then by citations
Research works printed but not linked: 2
- [6]Dobra R Guilmant E Higgins T Fleming S. Understanding and improving participants’ experience of health research; Patient evaluation of research participation in a dedicated respiratory biomedical reserach unit (BRU) Clinical resreach facility (CRF). In: Thorax, British Thoracic Society Winter Meeting, The Queen Elizabeth II Centre Broad Sanctuary Westminster London SW1P 3EE 2 to 4 December 2015 Programme and Abstracts, Vol. 70(Suppl 3), 2017.
- [15]Jiang D Kong W Jiang JJ. Patient engagement in randomized controlled clinical trials with Tai Chi intervention. Rev Recent Clin Trials 2016; 12(1): 24–33. 27527892
Cited by
Sorted by citations
SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials
Hróbjartsson, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · BMJ · doi:10.1136/bmj-2024-081660 · Cited by 171 · see citing works
- Authors
- Dobra, R., Wilson, G., Matthews, J., Boeri, M., Elborn, S., Kee, F., Davies, J. C., & Madge, S.
- Affiliations
- Royal Brompton Hospital (GB)
- Imperial College London (GB)
- RTI Solutions, Belfast, UK
- Queen's University, Belfast, UK
- Queen's University Belfast (GB)
- Corresponding author
- Dobra, Rebecca
- Venue
- JRSM Open
- Publisher
- SAGE Publications
- Published
- 2023-06
- Volume
- 14
- Issue
- 6
- Pages
- 20542704231166621-20542704231166621
- ISSN
- 2054-2704 (ISSN-L)
- PMC
- PMC10262634
- OpenAlex
- W4379795600
- Cited by
- 13
- References
- 26
- Citations by year
- 2026: 8 · 2025: 3 · 2024: 2
- FWCI
- 0.64
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- JRSM Open (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Research Portal (Queen's University Belfast) (acceptedVersion, cc-by-nc)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Spiral (Imperial College London) (submittedVersion, cc-by-nc)
- Funders
- National Institute for Health and Care Research (NIHR201402)
- Medical Research Council (MR/K023241/1)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Health Professions › General Health Professions › Mental Health and Patient Involvement
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- clinical trial participation, trial recruitment, trial retention, participant engagement, patient needs, psychosocial well-being
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
