Strategies for Increasing Recruitment to Randomised Controlled Trials: Systematic Review

English version České info

Background:
Recruitment of participants into randomised controlled trials (RCTs) is critical for successful trial conduct. Although there have been two previous systematic reviews on related topics, the results (which identified specific interventions) were inconclusive and not generalizable. The aim of our study was to evaluate the relative effectiveness of recruitment strategies for participation in RCTs.

Methods and Findings:
A systematic review, using the PRISMA guideline for reporting of systematic reviews, that compared methods of recruiting individual study participants into an actual or mock RCT were included. We searched MEDLINE, Embase, The Cochrane Library, and reference lists of relevant studies. From over 16,000 titles or abstracts reviewed, 396 papers were retrieved and 37 studies were included, in which 18,812 of at least 59,354 people approached agreed to participate in a clinical RCT. Recruitment strategies were broadly divided into four groups: novel trial designs (eight studies), recruiter differences (eight studies), incentives (two studies), and provision of trial information (19 studies). Strategies that increased people's awareness of the health problem being studied (e.g., an interactive computer program [relative risk (RR) 1.48, 95% confidence interval (CI) 1.00–2.18], attendance at an education session [RR 1.14, 95% CI 1.01–1.28], addition of a health questionnaire [RR 1.37, 95% CI 1.14–1.66]), or a video about the health condition (RR 1.75, 95% CI 1.11–2.74), and also monetary incentives (RR1.39, 95% CI 1.13–1.64 to RR 1.53, 95% CI 1.28–1.84) improved recruitment. Increasing patients' understanding of the trial process, recruiter differences, and various methods of randomisation and consent design did not show a difference in recruitment. Consent rates were also higher for nonblinded trial design, but differential loss to follow up between groups may jeopardise the study findings. The study's main limitation was the necessity of modifying the search strategy with subsequent search updates because of changes in MEDLINE definitions. The abstracts of previous versions of this systematic review were published in 2002 and 2007.

Conclusion:
Recruitment strategies that focus on increasing potential participants' awareness of the health problem being studied, its potential impact on their health, and their engagement in the learning process appeared to increase recruitment to clinical studies. Further trials of recruitment strategies that target engaging participants to increase their awareness of the health problems being studied and the potential impact on their health may confirm this hypothesis.

: Please see later in the article for the Editors' Summary

Vyšlo v časopise: Strategies for Increasing Recruitment to Randomised Controlled Trials: Systematic Review. PLoS Med 7(11): e32767. doi:10.1371/journal.pmed.1000368
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1000368

Souhrn

Zdroje

1. BartonS

2000 Which clinical studies provide the best evidence? The best RCT still trumps the best observational study. BMJ 321 255 256

2. SackettDL

RosenbergWM

GrayJA

HaynesRB

RichardsonWS

1996 Evidence based medicine: what it is and what it isn't. BMJ 312 71 72

3. LovatoLC

HillK

HertertS

HunninghakeDB

ProbstfieldJL

1997 Recruitment for controlled clinical trials: literature summary and annotated bibliography. Control Clin Trials 18 328 352

4. SwansonGM

WardAJ

1995 Recruiting minorities into clinical trials: toward a participant-friendly system. J Natl Cancer Inst 87 1747 1759

5. WalsonPD

1999 Patient recruitment: US perspective. Pediatrics 104 619 622

6. EasterbrookPJ

MatthewsDR

1992 Fate of research studies. J R Soc Med 85 71 76

7. BainesCJ

1984 Impediments to recruitment in the Canadian National Breast Screening Study: response and resolution. Control Clin Trials 5 129 140

8. ZifferblattSM

1975 Recruitment in large-scale clinical trials.

WeissSM

Proceedings of the National Heart and Lung Institute Working Conference on health behavior Bethesda NIH 187 195

9. MapstoneJ

ElbourneD

RobertsI

2007 Strategies to improve recruitment to research studies. Cochrane Database Syst Rev MR000013

10. WatsonJM

TorgersonDJ

2006 Increasing recruitment to randomised trials: a review of randomised controlled trials. BMC Med Res Methodol 6 34

11. CaldwellP

CraigJ

HamiltonS

ButowPN

2002 Strategies for recruitment to RCTs: a systematic review of controlled trials and observational studies. 2002 Oct 21; Sydney, Australia; International Clinical Trials Symposium: improving health care in the new millennium. http://www.ctc.usyd.edu.au/education/4news/Symposium2002_report/caldwell.htm

12. CaldwellP

CraigJ

HamiltonS

ButowPN

2007 Systematic review of strategies for enhancing recruitment of participants for randomised controlled trials. 2007 Sep 24; Sydney, Australia; International Clinical Trials Symposium

13. HigginsJ

GreenS

CochraneC

2008 Cochrane handbook for systematic reviews of interventions Chichester, England Wiley-Blackwell

14. HalpernSD

KarlawishJH

CasarettD

BerlinJA

AschDA

2004 Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials. Arch Intern Med 164 801 803

15. AvenellA

GrantAM

McGeeM

McPhersonG

CampbellMK

2004 The effects of an open design on trial participant recruitment, compliance and retention–a randomized controlled trial comparison with a blinded, placebo-controlled design. Clin Trials 1 490 498

16. HemminkiE

HoviS-L

VeerusP

SevonT

TuimalaR

2004 Blinding decreased recruitment in a prevention trial of postmenopausal hormone therapy. J Clin Epidemiol 57 1237 1243

17. WeltonAJ

VickersMR

CooperJA

MeadeTW

MarteauTM

1999 Is recruitment more difficult with a placebo arm in randomised controlled trials? A quasirandomised, interview based study. BMJ 318 1114 1117

18. GalloC

PerroneF

De PlacidoS

GiustiC

1995 Informed versus randomised consent to clinical trials. Lancet 346 1060 1064

19. MylesPS

FletcherHE

CairoS

MadderH

McRaeR

1999 Randomized trial of informed consent and recruitment for clinical trials in the immediate preoperative period. Anesthesiology 91 969 978

20. CooperKG

GrantAM

GarrattAM

1997 The impact of using a partially randomised patient preference design when evaluating alternative managements for heavy menstrual bleeding. BJOG 104 1367 1373

21. RogersCG

TysonJE

KennedyKA

BroylesRS

HickmanJF

1998 Conventional consent with opting in versus simplified consent with opting out: an exploratory trial for studies that do not increase patient risk. J Pediatr 132 606 611

22. SimelDL

FeussnerJR

1991 A randomized controlled trial comparing quantitative informed consent formats. J Clin Epidemiol 44 771 777

23. QuinauxE

LienardJL

SlimaniZ

JouhardA

PiedboisP

BuyseM

2003 Impact of monitoring visits on patient recruitment and data quality: case study of a phase IV trial in oncology. Control Clin Trials 24 99S [conference abstract]

24. KimmickGG

PetersonBL

KornblithAB

MandelblattJ

JohnsonJL

2005 Improving accrual of older persons to cancer treatment trials: a randomized trial comparing an educational intervention with standard information: CALGB 360001. J Clin Oncol 23 2201 2207

25. MonaghanH

RichensA

ColmanS

CurrieR

GirgisS

2007 A randomised trial of the effects of an additional communication strategy on recruitment into a large-scale, multi-centre trial. Contemp Clin Trials 28 1 5

26. LarkeyLK

StatenLK

RitenbaughC

HallRA

BullerDB

2002 Recruitment of Hispanic women to the Women's Health Initiative: the case of Embajadoras in Arizona. Control Clin Trials 23 289 298

27. FleissigA

JenkinsV

FallowfieldL

2001 Results of an intervention study to improve communication about randomised clinical trials of cancer therapy. Eur J Cancer 37 322 331

28. DonovanJL

PetersTJ

NobleS

PowellP

GillattD

2003 Who can best recruit to randomized trials? Randomized trial comparing surgeons and nurses recruiting patients to a trial of treatments for localized prostate cancer (the ProtecT study). J Clin Epidemiol 56 605 609

29. MillerNL

MarkowitzJC

KocsisJH

LeonAC

BriscoST

1999 Cost effectiveness of screening for clinical trials by research assistants versus senior investigators. J Psychiatr Res 33 81 85

30. LitchfieldJ

FreemanJ

SchouH

ElsleyM

FullerR

2005 Is the future for clinical trials internet-based? A cluster randomized clinical trial. Clin Trials 2 72 79

31. MartinsonBC

LazovichD

LandoHA

PerryCL

McGovernPG

2000 Effectiveness of monetary incentives for recruiting adolescents to an intervention trial to reduce smoking. Prev Med 31 706 713

32. KendrickD

WatsonM

DeweyM

WoodsAJ

2001 Does sending a home safety questionnaire increase recruitment to an injury prevention trial? A randomised controlled trial. J Epidemiol Community Health 55 845 846

33. KiernanM

PhillipsK

FairJM

KingAC

2000 Using direct mail to recruit Hispanic adults into a dietary intervention: an experimental study. Ann Behav Med 22 89 93

34. TworogerSS

YasuiY

UlrichCM

NakamuraH

LaCroixK

2002 Mailing strategies and recruitment into an intervention trial of the exercise effect on breast cancer biomarkers. Cancer Epidemiol Biomarkers Prev 11 73 77

35. ValanisB

BlankJ

GlassA

1998 Mailing strategies and costs of recruiting heavy smokers in CARET, a large chemoprevention trial. Control Clin Trials 19 25 38

36. NystuenP

HagenKB

2004 Telephone reminders are effective in recruiting nonresponding patients to randomized controlled trials. J Clin Epidemiol 57 773 776

37. FordME

HavstadSL

DavisSD

2004 A randomized trial of recruitment methods for older African American men in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. Clin Trials 1 343 351

38. LeiraEC

AhmedA

LambDL

OlaldeHM

CallisonRC

2009 Extending acute trials to remote populations a pilot study during interhospital helicopter transfer. Stroke 40 895 901

39. CoyneCA

XuR

RaichP

PlomerK

DignanM

2003 Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group. J Clin Oncol 21 836 842

40. EllisPM

ButowPN

TattersallMH

2002 Informing breast cancer patients about clinical trials: a randomized clinical trial of an educational booklet. Ann Oncol 13 1414 1423

41. DuW

MoodD

GadgeelS

SimonMS

2008 An educational video to increase clinical trials enrollment among lung cancer patients. J Thorac Oncol 3 23 29

42. HutchisonC

CowanC

McMahonT

PaulJ

2007 A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials. Br J Cancer 97 705 711

43. Llewellyn-ThomasHA

ThielEC

SemFW

WoermkeDE

1995 Presenting clinical trial information: a comparison of methods. Patient Educ Couns 25 97 107

44. WestonJ

HannahM

DownesJ

1997 Evaluating the benefits of a patient information video during the informed consent process. Patient Educ Couns 30 239 245

45. BernerES

PartridgeEE

BaumSK

1997 The effects of the pdq patient information file (pif) on patients' knowledge, enrollment in clinical trials, and satisfaction. J Cancer Educ 12 121 125

46. WadlandWC

HughesJR

Secker-WalkerRH

BronsonDL

FenwickJ

1990 Recruitment in a primary care trial on smoking cessation. Fam Med 22 201 204

47. AaronsonNK

Visser-PolE

LeenhoutsGH

MullerMJ

van der SchotAC

1996 Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. J Clin Oncol 14 984 996

48. MandelblattJ

KaufmanE

SheppardVB

PomeroyJ

KavanaughJ

2005 Breast cancer prevention in community clinics: Will low-income Latina patients participate in clinical trials? Prev Med 40 611 612

49. SimesRJ

TattersallMH

CoatesAS

RaghavanD

SolomonHJ

1986 Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer. Br Med J (Clin Res Ed) 293 1065 1068

50. WraggJA

RobinsonEJ

LilfordRJ

2000 Information presentation and decisions to enter clinical trials: a hypothetical trial of hormone replacement therapy. Soc Sci Med 51 453 462

51. PighillsA

TorgensonDJ

SheldonT

2009 Publicity does not increase recruitment to falls prevention trials: the results of two quasi-randomized trials. J Clin Epidemiol 62 1332 1335

52. LeaderMA

NeuwirthE

1978 Clinical research and the noninstitutional elderly: a model for subject recruitment. Journal J Am Geriatr Soc 26 27 31

53. CaldwellPH