Challenges of Recruitment and Retention in Multisite Clinical Research

Cooley, Mary E.; Sarna, Linda; Brown, Jean K.; Williams, Roma D.; Chernecky, Cynthia; Padilla, Geraldine; Danao, Leda L.

doi:10.1097/00002820-200310000-00006

Cited by 83 publications

(83 citation statements)

References 37 publications

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“…A further 21% completed two of the outcome assessments, which increased the overall data available for statistical analysis. High attrition rates are commonplace in this type of research (Bottomley et al, 2003) with previous studies in palliative care settings finding that only 44% of patients completed all study procedures (Ling et al, 2000) and attrition rates of 47% occurred at some recruitment sites in a large American lung cancer study (Cooley et al, 2003). The main reasons for not completing assessments were death or deterioration in health and again this concurs with other research in this area.…”

Section: Attrition Ratesupporting

confidence: 79%

Feasibility of a standardised quality of life questionnaire in a weekly diary format for inoperable lung cancer patients

Mills¹,

Murray²,

Johnston³

et al. 2008

European Journal of Oncology Nursing

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a b s t r a c tObjective: Previous studies testing quality of life assessment (QoL) in routine oncology clinical practice have been based at single institutions and many have utilised touch-screen computer technology. The objective of this study was to test the feasibility of a low-tech QoL diary that could be held by the patient and shared with professionals across the health care setting. Methods:The EORTC-QLQ-C30 and LC13 were used and adapted into an A5 diary format. Patients were instructed to complete the questions each week at home and to share the information with any health professional involved in their care. Feasibility of the diary format was examined through assessment of compliance, utilisation and satisfaction using a mixed methods approach.Results: Diary completion rates were good; however, utilisation of the diary was poor, with only 23% (13/57) of patients stating explicitly that they had shared the diary with a health professional. Patients were generally satisfied with the diary format; however, qualitative analysis did identify some negative effects of diary completion. Conclusions: A patient-held QoL diary is feasible for a proportion of palliative care patients but the importance of training and support for patients and staff cannot be underestimated when implementing a new tool into clinical practice.

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Section: Attrition Ratesupporting

confidence: 79%

Feasibility of a standardised quality of life questionnaire in a weekly diary format for inoperable lung cancer patients

Mills¹,

Murray²,

Johnston³

et al. 2008

European Journal of Oncology Nursing

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“…In addition, high attrition requires larger sample sizes to maintain statistical power and subsequently inflates trial duration and costs. 3,4 Amyotrophic lateral sclerosis (ALS) is a rare neurologic disorder that has many potential therapies currently in development. 5 With a small patient population and limited funds, it is critical that clinical trials are well designed and efficiently run.…”

mentioning

confidence: 99%

Analysis of start-up, retention, and adherence in ALS clinical trials

Atassi¹,

Yerramilli-Rao²,

Szymonifka³

et al. 2013

Neurology

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Objective: To investigate predictors of trial start-up times, high attrition, and poor protocol adherence in amyotrophic lateral sclerosis (ALS) trials.Methods: Retrospective analysis of start-up times, retention, and protocol adherence was performed on 5 clinical studies conducted by the Northeast ALS Consortium and 50 ALS clinical trials identified by PubMed search. Predictors of start-up times were estimated by accelerated failure time models with random effects. Predictors of retention and protocol deviations were estimated by mixed-model logistic regression.Results: Median times for contract execution and institutional review board (IRB) approval were 105 days and 125 days, respectively. Contract execution was faster at sites with more ongoing trials (p 5 0.005), and more full-time (p 5 0.006) and experienced (p , 0.001) coordinators. IRB approval was faster at sites with more ongoing trials (p 5 0.010) and larger ALS clinics (p 5 0.038). Site activation after IRB approval was faster at sites with more full-time (p 5 0.038) and experienced (p , 0.001) coordinators. Twenty-two percent of surviving participants withdrew before completing the trial. Better participant functional score at baseline was an independent predictor of trial completion (odds ratio 1.29, p 5 0.002) and fewer protocol deviations (odds ratio 0.86, p 5 0.030).Conclusion: Delays in IRB review contribute the most to prolonged trial start-up times, and these timelines are faster in sites with more experienced staff. Strategies to improve protocol adherence and participants' retention may include enrolling people at early disease stages. The translation of basic research to clinical practice depends on the conduct of well-designed and efficient clinical trials. Delays in study start-up, high participant attrition, and poor adherence to the study protocol reduce trial validity and inflate the timelines and costs of drug development. In published clinical trials, enrollment and retention data are routinely reported; however, factors affecting study start-up times, retention, and adherence to the protocol are rarely mentioned. 1,2Conducting efficient clinical trials involves completing study start-up processes in a timely manner. This includes execution of the site contracts, obtaining institutional review board (IRB) approvals, and completing protocol, pharmacy, and outcomes trainings. Delays in the study start-up process can extend trial duration and costs, threaten trial feasibility, and delay answering important clinical questions.The internal validity of a clinical trial depends largely on good conduct including retention and maintaining good protocol adherence (i.e., complying with the study protocol). In addition, high attrition requires larger sample sizes to maintain statistical power and subsequently inflates trial duration and costs. 3,4 Amyotrophic lateral sclerosis (ALS) is a rare neurologic disorder that has many potential therapies currently in development.5 With a small patient population and limited funds, it is critical

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“…Investigators have noted that monetary appreciation plays a role in motivating women to participate, and can be preferred over other tokens such as gifts (Cooley et al, 2003). The incentives in WTW were different for the computer groups versus the control group.…”

Section: Discussionmentioning

confidence: 99%

Retention in a computer-based outreach intervention for chronically ill rural women

Weinert¹,

Cudney²,

Hill³

2008

Applied Nursing Research

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The study's purpose was to examine retention factors in a computer intervention with 158 chronically ill rural women. After a 22 week intervention, 18.9 percent of the women had dropped out. A Cox regression survival analysis was performed to assess the effects of selected covariates on retention. Reasons for dropping were tallied and categorized. Major reasons for dropping were: lack of time; decline in health status, and non-participation in study activities. Four covariates predicted survival time: level of computer skills, marital status, work outside of home, and impact of social events on participants' lives. Retention-enhancing strategies are suggested for implementation. Factors Related to Retention in a Computer Outreach Intervention For Chronically Ill Rural WomenA consistent problem in interventional longitudinal research is the loss of participants over time (Mason, 1999). Participants' dropping out of a project before its completion or researchers dropping participants from a study if they missed data-collection points is known as attrition. Although longitudinal design is useful in interventional studies because it provides an opportunity to study the nature and results of change as individuals move through developmental and transitional experiences such as chronic illness, participant attrition is one of its greatest disadvantages (Marcellus, 2004). Rates for attrition vary across the literature for intervention and longitudinal follow-up, with 80% completion rate considered reasonable. Although a drop-out rate of 20% can be expected, bias is a concern if attrition exceeds 20%. Non-completion can have significant impact on the validity of the study and theory development resulting from the study (Mason, 1999;Sullivan, 2004).Factors associated with retention/attrition are considered by Marcellus (2004) to be underreported and understudied. To improve participant retention in research-based interventions, the barriers to retaining participants need to be identified to make it possible for appropriate strategies to be implemented that can overcome them (Sullivan, 2004). Sage (2001) proposed that there could be a difference in participants who stay with a study throughout its entire duration and those who do not. Consistent with these recommendations * Lead author and address for reprint requests.No conflict of interest or financial disclosure statements are required. for the study of retention/attrition phenomena, the factors that influenced retention and attrition in a computer-based outreach project for chronically ill rural women in sparsely populated western states were examined. NIH Public AccessThe Women to Women Project (WTW) at Montana State University College of Nursing has been using telecommunication to shrink the distances from health resources and counter the isolation of rural women living with chronic illness. WTW connects the women with one another and gives them access to information on living with long-term illness in an attempt to help them better adapt to their chronic con...

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Challenges of Recruitment and Retention in Multisite Clinical Research

Cited by 83 publications

References 37 publications

Feasibility of a standardised quality of life questionnaire in a weekly diary format for inoperable lung cancer patients

Feasibility of a standardised quality of life questionnaire in a weekly diary format for inoperable lung cancer patients

Analysis of start-up, retention, and adherence in ALS clinical trials

Retention in a computer-based outreach intervention for chronically ill rural women

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