IDEAS home Printed from https://ideas.repec.org/a/plo/pone00/0056560.html
   My bibliography  Save this article

Centre Selection for Clinical Trials and the Generalisability of Results: A Mixed Methods Study

Author

Listed:
  • Adrian Gheorghe
  • Tracy E Roberts
  • Jonathan C Ives
  • Benjamin R Fletcher
  • Melanie Calvert

Abstract

Background: The rationale for centre selection in randomised controlled trials (RCTs) is often unclear but may have important implications for the generalisability of trial results. The aims of this study were to evaluate the factors which currently influence centre selection in RCTs and consider how generalisability considerations inform current and optimal practice. Methods and Findings: Mixed methods approach consisting of a systematic review and meta-summary of centre selection criteria reported in RCT protocols funded by the UK National Institute of Health Research (NIHR) initiated between January 2005-January 2012; and an online survey on the topic of current and optimal centre selection, distributed to professionals in the 48 UK Clinical Trials Units and 10 NIHR Research Design Services. The survey design was informed by the systematic review and by two focus groups conducted with trialists at the Birmingham Centre for Clinical Trials. 129 trial protocols were included in the systematic review, with a total target sample size in excess of 317,000 participants. The meta-summary identified 53 unique centre selection criteria. 78 protocols (60%) provided at least one criterion for centre selection, but only 31 (24%) protocols explicitly acknowledged generalisability. This is consistent with the survey findings (n = 70), where less than a third of participants reported generalisability as a key driver of centre selection in current practice. This contrasts with trialists’ views on optimal practice, where generalisability in terms of clinical practice, population characteristics and economic results were prime considerations for 60% (n = 42), 57% (n = 40) and 46% (n = 32) of respondents, respectively. Conclusions: Centres are rarely enrolled in RCTs with an explicit view to external validity, although trialists acknowledge that incorporating generalisability in centre selection should ideally be more prominent. There is a need to operationalize ‘generalisability’ and incorporate it at the design stage of RCTs so that results are readily transferable to ‘real world’ practice.

Suggested Citation

  • Adrian Gheorghe & Tracy E Roberts & Jonathan C Ives & Benjamin R Fletcher & Melanie Calvert, 2013. "Centre Selection for Clinical Trials and the Generalisability of Results: A Mixed Methods Study," PLOS ONE, Public Library of Science, vol. 8(2), pages 1-9, February.
    • Handle: RePEc:plo:pone00:0056560
    DOI: 10.1371/journal.pone.0056560
    as

    Download full text from publisher

    File URL: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0056560
    Download Restriction: no
    File URL: https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0056560&type=printable
    Download Restriction: no
    File URL: https://libkey.io/10.1371/journal.pone.0056560?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    References listed on IDEAS

    as
    1. Andrea Manca & Nigel Rice & Mark J. Sculpher & Andrew H. Briggs, 2005. "Assessing generalisability by location in trial‐based cost‐effectiveness analysis: the use of multilevel models," Health Economics, John Wiley & Sons, Ltd., vol. 14(5), pages 471-485, May.
    2. Elizabeth R. DeLong & Laura P. Coombs & T. Bruce Ferguson Jr. & Eric D. Peterson, 2005. "The Evaluation of Treatment When Center-Specific Selection Criteria Vary with Respect to Patient Risk," Biometrics, The International Biometric Society, vol. 61(4), pages 942-949, December.
    3. Kenneth F Schulz & Douglas G Altman & David Moher & for the CONSORT Group, 2010. "CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials," PLOS Medicine, Public Library of Science, vol. 7(3), pages 1-7, March.
    4. Andrea Manca & Paul C. Lambert & Mark Sculpher & Nigel Rice, 2007. "Cost-Effectiveness Analysis Using Data from Multinational Trials: The Use of Bivariate Hierarchical Modeling," Medical Decision Making, , vol. 27(4), pages 471-490, July.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. Raymond Oppong & Sue Jowett & Tracy E Roberts, 2015. "Economic Evaluation alongside Multinational Studies: A Systematic Review of Empirical Studies," PLOS ONE, Public Library of Science, vol. 10(6), pages 1-22, June.
    2. Adrian Gheorghe & Tracy Roberts & Thomas D. Pinkney & Dion G. Morton & Melanie Calvert, 2015. "Rational Centre Selection for RCTs with a Parallel Economic Evaluation—the Next Step Towards Increased Generalisability?," Health Economics, John Wiley & Sons, Ltd., vol. 24(4), pages 498-504, April.
    3. Adam Steventon & Richard Grieve & Martin Bardsley, 2015. "An Approach to Assess Generalizability in Comparative Effectiveness Research," Medical Decision Making, , vol. 35(8), pages 1023-1036, November.
    4. Arnaud Vaganay, 2016. "Cluster Sampling Bias in Government-Sponsored Evaluations: A Correlational Study of Employment and Welfare Pilots in England," PLOS ONE, Public Library of Science, vol. 11(8), pages 1-21, August.
    5. David G. Lugo‐Palacios & Patrick Bidulka & Stephen O’Neill & Orlagh Carroll & Anirban Basu & Amanda Adler & Karla DíazOrdaz & Andrew Briggs & Richard Grieve, 2025. "Going beyond randomised controlled trials to assess treatment effect heterogeneity across target populations," Health Economics, John Wiley & Sons, Ltd., vol. 34(1), pages 85-104, January.

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Moreno, Elías & Girón, F.J. & Vázquez-Polo, F.J. & Negrín, M.A., 2012. "Optimal healthcare decisions: The importance of the covariates in cost–effectiveness analysis," European Journal of Operational Research, Elsevier, vol. 218(2), pages 512-522.
    2. Ángel Enrique & Juana Bretón-López & Guadalupe Molinari & Rosa M. Baños & Cristina Botella, 2018. "Efficacy of an adaptation of the Best Possible Self intervention implemented through positive technology: a randomized control trial," Applied Research in Quality of Life, Springer;International Society for Quality-of-Life Studies, vol. 13(3), pages 671-689, September.
    3. Gerben ter Riet & Paula Chesley & Alan G Gross & Lara Siebeling & Patrick Muggensturm & Nadine Heller & Martin Umbehr & Daniela Vollenweider & Tsung Yu & Elie A Akl & Lizzy Brewster & Olaf M Dekkers &, 2013. "All That Glitters Isn't Gold: A Survey on Acknowledgment of Limitations in Biomedical Studies," PLOS ONE, Public Library of Science, vol. 8(11), pages 1-6, November.
    4. Spyridon N Papageorgiou & Georgios N Antonoglou & George K Sándor & Theodore Eliades, 2017. "Randomized clinical trials in orthodontics are rarely registered a priori and often published late or not at all," PLOS ONE, Public Library of Science, vol. 12(8), pages 1-13, August.
    5. Eun-Hi Kong & Myoungsuk Kim & Seonho Kim, 2021. "Effects of a Web-Based Educational Program Regarding Physical Restraint Reduction in Long-Term Care Settings on Nursing Students: A Cluster Randomized Controlled Trial," IJERPH, MDPI, vol. 18(13), pages 1-10, June.
    6. Stavros Petrou & Oliver Rivero-Arias & Helen Dakin & Louise Longworth & Mark Oppe & Robert Froud & Alastair Gray, 2015. "Preferred Reporting Items for Studies Mapping onto Preference-Based Outcome Measures: The MAPS Statement," Medical Decision Making, , vol. 35(6), pages 1-8, August.
    7. Alexander P. L. Martindale & Carrie D. Llewellyn & Richard O. Visser & Benjamin Ng & Victoria Ngai & Aditya U. Kale & Lavinia Ferrante Ruffano & Robert M. Golub & Gary S. Collins & David Moher & Melis, 2024. "Concordance of randomised controlled trials for artificial intelligence interventions with the CONSORT-AI reporting guidelines," Nature Communications, Nature, vol. 15(1), pages 1-11, December.
    8. Maria Giné-Garriga & Carme Martin-Borràs & Anna Puig-Ribera & Carlos Martín-Cantera & Mercè Solà & Antonio Cuesta-Vargas & on behalf of the PPAF Group, 2013. "The Effect of a Physical Activity Program on the Total Number of Primary Care Visits in Inactive Patients: A 15-Month Randomized Controlled Trial," PLOS ONE, Public Library of Science, vol. 8(6), pages 1-8, June.
    9. Nahid Norouzi-Gheidari & Alejandro Hernandez & Philippe S. Archambault & Johanne Higgins & Lise Poissant & Dahlia Kairy, 2019. "Feasibility, Safety and Efficacy of a Virtual Reality Exergame System to Supplement Upper Extremity Rehabilitation Post-Stroke: A Pilot Randomized Clinical Trial and Proof of Principle," IJERPH, MDPI, vol. 17(1), pages 1-11, December.
    10. Juliusz Huber & Katarzyna Kaczmarek & Katarzyna Leszczyńska & Przemysław Daroszewski, 2022. "Post-Stroke Treatment with Neuromuscular Functional Electrostimulation of Antagonistic Muscles and Kinesiotherapy Evaluated with Electromyography and Clinical Studies in a Two-Month Follow-Up," IJERPH, MDPI, vol. 19(2), pages 1-17, January.
    11. Süreyya Kılıç & Sema Dereli Yılmaz, 2023. "Virtual Reality Headset Simulating a Nature Environment to Improve Health Outcomes in Pregnant Women: A Randomized-Controlled Trial," Clinical Nursing Research, , vol. 32(8), pages 1104-1114, November.
    12. Denise Howel & Suzanne Moffatt & Catherine Haighton & Andrew Bryant & Frauke Becker & Melanie Steer & Sarah Lawson & Terry Aspray & Eugene M G Milne & Luke Vale & Elaine McColl & Martin White, 2019. "Does domiciliary welfare rights advice improve health-related quality of life in independent-living, socio-economically disadvantaged people aged ≥60 years? Randomised controlled trial, economic and p," PLOS ONE, Public Library of Science, vol. 14(1), pages 1-31, January.
    13. Reynolds, J.P. & Pilling, M. & Marteau, T.M., 2018. "Communicating quantitative evidence of policy effectiveness and support for the policy: Three experimental studies," Social Science & Medicine, Elsevier, vol. 218(C), pages 1-12.
    14. Marlene De Fabritiis & Federica Trisolini & Gloria Bertuletti & Ionut Daniel Fagadau & Davide Ginelli & Katiuscia Pia Lalopa & Lisa Peverelli & Alessia Pirola & Gaia Sala & Marta Maisto & Fabio Madedd, 2022. "An Internet-Based Multi-Approach Intervention Targeting University Students Suffering from Psychological Problems: Design, Implementation, and Evaluation," IJERPH, MDPI, vol. 19(5), pages 1-15, February.
    15. Andreas C Drichoutis & Rodolfo M Nayga, 2020. "Economic Rationality under Cognitive Load," The Economic Journal, Royal Economic Society, vol. 130(632), pages 2382-2409.
    16. Natalia Stanulewicz & Emily Knox & Melanie Narayanasamy & Noureen Shivji & Kamlesh Khunti & Holly Blake, 2019. "Effectiveness of Lifestyle Health Promotion Interventions for Nurses: A Systematic Review," IJERPH, MDPI, vol. 17(1), pages 1-36, December.
    17. Jörg Peters & Jörg Langbein & Gareth Roberts, 2018. "Generalization in the Tropics – Development Policy, Randomized Controlled Trials, and External Validity," The World Bank Research Observer, World Bank, vol. 33(1), pages 34-64.
    18. Jonas Czwikla & Alexandra Herzberg & Sonja Kapp & Stephan Kloep & Heinz Rothgang & Ina Nitschke & Cornelius Haffner & Falk Hoffmann, 2021. "Effectiveness of a Dental Intervention to Improve Oral Health among Home Care Recipients: A Randomized Controlled Trial," IJERPH, MDPI, vol. 18(17), pages 1-13, September.
    19. Yuan Sheng & Li-Hong Yang & Yan Wu & Wei Gao & Sheng-Yi Dongye, 2024. "Implementation of Tunneled Peripherally Inserted Central Catheters Placement in Cancer Patients: A Randomized Multicenter Study," Clinical Nursing Research, , vol. 33(1), pages 19-26, January.
    20. Maria Paula Valk-Draad & Sabine Bohnet-Joschko, 2022. "Nursing Home-Sensitive Hospitalizations and the Relevance of Telemedicine: A Scoping Review," IJERPH, MDPI, vol. 19(19), pages 1-23, October.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:plo:pone00:0056560. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: plosone (email available below). General contact details of provider: https://journals.plos.org/plosone/ .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.