Chlebowski RT, Hendrix SL, Langer RD, et al. Influence of estrogen plus progestin on breast cancer and mammography in healthy postmenopausal women: the Women’s Health Initiative randomized trial. JAMA. 2003;289(24):3243–53.
Article
CAS
PubMed
Google Scholar
Nipp RD, Powell E, Chabner B, Moy B. Recognizing the financial burden of cancer patients in clinical trials. Oncologist. 2015;20(6):572–5.
Article
PubMed
PubMed Central
Google Scholar
Kimmelman J, Resnik DB, Peppercorn J, Ratain MJ: Burdensome research procedures in trials: why less is more. J Natl Cancer Inst. 2017;109(4):djw315.
Townsley CA, Selby R, Siu LL. Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials. J Clin Oncol. 2005;23(13):3112–24.
Article
PubMed
Google Scholar
Treweek S, Pitkethly M, Cook J, Fraser C, Mitchell E, Sullivan F, Jackson C, Taskila TK, Gardner H. Strategies to improve recruitment to randomised trials. Cochrane Database Syst Rev. 2018;2:MR000013.
PubMed
Google Scholar
Brueton VC, Tierney J, Stenning S, Harding S, Meredith S, Nazareth I, Rait G. Strategies to improve retention in randomised trials. Cochrane Database Syst Rev. 2013;12:MR000032.
Google Scholar
Skea ZC, Newlands R, Gillies K. Exploring non-retention in clinical trials: a meta-ethnographic synthesis of studies reporting participant reasons for drop out. BMJ Open. 2019;9(6):e021959.
Article
PubMed
PubMed Central
Google Scholar
Thomas J, Harden A. Methods for the thematic synthesis of qualitative research in systematic reviews. BMC Med Res Methodol. 2008;8:45.
Article
PubMed
PubMed Central
Google Scholar
Harris JL, Booth A, Cargo M, Hannes K, Harden A, Flemming K, Garside R, Pantoja T, Thomas J, Noyes J. Cochrane Qualitative and Implementation Methods Group guidance paper 6: methods for question formulation, searching, and protocol development for qualitative evidence synthesis. J Clin Epidemiol. 2017.
Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097.
Article
PubMed
PubMed Central
Google Scholar
Tong A, Flemming K, McInnes E, Oliver S, Craig J. Enhancing transparency in reporting the synthesis of qualitative research: ENTREQ. BMC Med Res Methodol. 2012;12(1):181.
Article
PubMed
PubMed Central
Google Scholar
Methley AM, Campbell S, Chew-Graham C, McNally R, Cheraghi-Sohi S. PICO, PICOS and SPIDER: a comparison study of specificity and sensitivity in three search tools for qualitative systematic reviews. BMC Health Serv Res. 2014;14:579.
Article
PubMed
PubMed Central
Google Scholar
Shaw RL, Booth A, Sutton AJ, Miller T, Smith JA, Young B, Jones DR, Dixon-Woods M. Finding qualitative research: an evaluation of search strategies. BMC Med Res Methodol. 2004;4:5–5.
Article
PubMed
PubMed Central
Google Scholar
Evans D. Database searches for qualitative research. J Med Library Association. 2002;90(3):290–3.
Google Scholar
Booth A: Chapter 3: searching for studies. In: Supplementary guidance for inclusion of qualitative research in Cochrane systematic reviews of interventions. Edited by Noyes J BA, Hannes K, Harden A, Harris J, Lewin S, Lockwood C, vol. version 1 (updated August 2011): Cochrane Collaboration Qualitative Methods Group, 2011; 2011.
Booth A. Searching for qualitative research for inclusion in systematic reviews: a structured methodological review. Syst Rev. 2016;5:74.
Article
PubMed
PubMed Central
Google Scholar
Lingler JH, Schmidt K, Gentry A, Hu L, Terhorst L. Perceived Research Burden Assessment (PeRBA): instrument development and psychometric evaluation. JERHRE. 2014;9(4):46–9.
Article
PubMed
Google Scholar
Ulrich CM, Wallen GR, Feister A, Grady C. Respondent burden in clinical research: when are we asking too much of subjects? IRB. 2005;27(4):17–20.
Article
PubMed
Google Scholar
Mays N, Pope C. Rigour and qualitative research. Br Med J. 1995;311(6997):109–12.
Article
CAS
Google Scholar
Verboom B, Montgomery P, Bennett S. What factors affect evidence-informed policymaking in public health? Protocol for a systematic review of qualitative evidence using thematic synthesis. Syst Rev. 2016;5:61.
Article
PubMed
PubMed Central
Google Scholar
Lingler JH, Schmidt KL, Gentry AL, Hu L, Terhorst LA. A new measure of research participant burden: brief report. J Empir Res Hum Res Ethics. 2014;9(4):46–9.
Article
PubMed
PubMed Central
Google Scholar
Anderson A, Borfitz D, Getz K. Global public attitudes about clinical research and patient experiences with clinical trials. JAMA Netw Open. 2018;1(6):e182969.
Article
PubMed
PubMed Central
Google Scholar
Healy P, Galvin S, Williamson PR, Treweek S, Whiting C, Maeso B, Bray C, Brocklehurst P, Moloney MC, Douiri A, et al. Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - the PRioRiTy (Prioritising Recruitment in Randomised Trials) study. Trials. 2018;19(1):147.
Article
PubMed
PubMed Central
Google Scholar
What are the most important unanswered questions in trial retention? A James Lind Alliance Priority Setting Partnership - The PRioRiTy 2 (Prioritising Retention in Randomised Trials) Study [https://www.researchsquare.com/article/588284a5-b216-40cb-a405-25138610efa2/v1]. Accessed 10 Dec.
Mills EJ, Seely D, Rachlis B, Griffith L, Wu P, Wilson K, Ellis P, Wright JR. Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. Lancet Oncol. 2006;7(2):141–8.
Article
PubMed
Google Scholar
Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999;52(12):1143–56.
Article
CAS
PubMed
Google Scholar
Gross CP, Mallory R, Heiat A, Krumholz HM. Reporting the recruitment process in clinical trials: who are these patients and how did they get there? Ann Intern Med. 2002;137(1):10–6.
Article
PubMed
Google Scholar
McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, Elbourne DR, Francis D, Garcia J, Roberts I, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9.
Article
PubMed
PubMed Central
Google Scholar
Fletcher B, Gheorghe A, Moore D, Wilson S, Damery S. Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open. 2012;2(1):e000496.
Article
PubMed
PubMed Central
Google Scholar
Shimm DS, Spece RG. Rate of refusal to participate in clinical trials. IRB. 1992;14(2):7–9.
Article
PubMed
Google Scholar
Toerien M, Brookes ST, Metcalfe C, de Salis I, Tomlin Z, Peters TJ, Sterne J, Donovan JL. A review of reporting of participant recruitment and retention in RCTs in six major journals. Trials. 2009;10:52.
Article
PubMed
PubMed Central
Google Scholar
Dechartres A, Trinquart L, Boutron I, Ravaud P. Influence of trial sample size on treatment effect estimates: meta-epidemiological study. BMJ. 2013;346:f2304.
Article
PubMed
PubMed Central
Google Scholar
Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, Briel M, Lacchetti C, Leung TW, Darling E, Bryant DM, et al. Randomized trials stopped early for benefit: a systematic review. JAMA. 2005;294(17):2203–9.
Article
CAS
PubMed
Google Scholar
Rothwell PM. External validity of randomised controlled trials: “to whom do the results of this trial apply?”. Lancet. 2005;365(9453):82–93.
Article
PubMed
Google Scholar
Ahmad N, Boutron I, Moher D, Pitrou I, Roy C, Ravaud P. Neglected external validity in reports of randomized trials: the example of hip and knee osteoarthritis. Arthritis Rheum. 2009;61(3):361–9.
Article
PubMed
PubMed Central
Google Scholar
Dekkers OM, von Elm E, Algra A, Romijn JA, Vandenbroucke JP. How to assess the external validity of therapeutic trials: a conceptual approach. Int J Epidemiol. 2009;39(1):89–94.
Article
PubMed
Google Scholar
Ethgen M, Boutron L, Steg PG, Roy C, Ravaud P. Quality of reporting internal and external validity data from randomized controlled trials evaluating stents for percutaneous coronary intervention. BMC Med Res Methodol. 2009;9:24.
Article
PubMed
PubMed Central
Google Scholar
Tobias JS, Souhami RL. Fully informed consent can be needlessly cruel. BMJ. 1993;307(6913):1199–201.
Article
CAS
PubMed
PubMed Central
Google Scholar
Sara Dick M, CCRP: minimally disruptive research: a respectful approach to conducting clinical studies. In. Edited by UNIT K; 2017.
Todres L, Galvin KT, Holloway I. The humanization of healthcare: a value framework for qualitative research. Int J Qual Stud Health Well Being. 2009;4(2):68–77.
Article
Google Scholar
Youngson R, Blennerhassett M. Humanising healthcare. BMJ. 2016;355:i6262.
Article
PubMed
Google Scholar
Treweek S, Bevan S, Bower P, Campbell M, Christie J, Clarke M, Collett C, Cotton S, Devane D, El Feky A, et al. Trial forge guidance 1: what is a Study Within A Trial (SWAT)? Trials. 2018;19(1):139.
Article
PubMed
PubMed Central
Google Scholar
Relton C, Torgerson D, O’Cathain A, Nicholl J. Rethinking pragmatic randomised controlled trials: introducing the “cohort multiple randomised controlled trial” design. BMJ. 2010;340:c1066.
Article
PubMed
Google Scholar
Wicks P, Richards T, Denegri S, Godlee F. Patients’ roles and rights in research. BMJ. 2018;362:k3193.
Article
PubMed
Google Scholar
Montori V. Why we revolt: a patient revolution for careful and kind care: patient revolution; 2017.
Google Scholar
O'Leary E, Seow H, Julian J, Levine M, Pond GR. Data collection in cancer clinical trials: too much of a good thing? Clin Trials. 2013;10(4):624–32.
Article
PubMed
Google Scholar
Caron-Flinterman JF, Broerse JE, Bunders JF. The experiential knowledge of patients: a new resource for biomedical research? Soc Sci Med. 2005;60(11):2575–84.
Article
PubMed
Google Scholar
Domecq JP, Prutsky G, Elraiyah T, Wang Z, Nabhan M, Shippee N, Brito JP, Boehmer K, Hasan R, Firwana B, et al. Patient engagement in research: a systematic review. BMC Health Serv Res. 2014;14:89.
Article
PubMed
PubMed Central
Google Scholar
Rolfe DE, Ramsden VR, Banner D, Graham ID. Using qualitative Health Research methods to improve patient and public involvement and engagement in research. Res Involvement Engagement. 2018;4:49.
Article
Google Scholar
Price A, Albarqouni L, Kirkpatrick J, Clarke M, Liew SM, Roberts N, Burls A. Patient and public involvement in the design of clinical trials: an overview of systematic reviews. J Eval Clin Pract. 2018;24(1):240–53.
Article
PubMed
Google Scholar
Borno HT, Zhang L, Siegel A, Chang E, Ryan CJ. At what cost to clinical trial enrollment? A retrospective study of patient travel burden in cancer clinical trials. Oncologist. 2018;23(10):1242–9.
Article
PubMed
PubMed Central
Google Scholar
Noyes J, Booth A, Flemming K, Garside R, Harden A, Lewin S, Pantoja T, Hannes K, Cargo M, Thomas J. Cochrane Qualitative and Implementation Methods Group guidance paper 3: methods for assessing methodological limitations, data extraction and synthesis, and confidence in synthesized qualitative findings. J Clin Epidemiol. 2018;97:49–58.
Article
PubMed
Google Scholar