Recruitment for controlled clinical trials: Literature summary and annotated bibliography

Lovato, Laura; Hill, Kristin; Hertert, Stephanie; Hunninghake, Donald B.; Probstfield, Jeffrey L.

doi:10.1016/s0197-2456(96)00236-x

Cited by 369 publications

(324 citation statements)

References 68 publications

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“…Although there are discreet scientific and ethical challenges in each phase of clinical trial, the randomised phase III trial has been shown to be particularly problematic in relation to misinterpretation and poor understanding of patient information, often in relation to the concept of randomisation (Sutherland et al, 1990;Lovato et al, 1997;Featherstone and Donovan, 2002). Compared with earlier phase studies (Gordon and Daugherty, 2001), relatively high rates of patient refusal have been reported: 28% (Jenkins and Fallowfield, 2000), 40% (Klabunde et al, 1999) and 49% (Lara et al, 2001).…”

Section: Clinical Trials and Recruitmentmentioning

confidence: 99%

A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials

et al. 2007

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Recruitment to cancer clinical trials needs to be improved, as does patient knowledge and understanding about clinical trials, in order for patients to make an informed choice about whether or not to take part. Audiovisual patient information (AVPI) has been shown to improve knowledge and understanding in various areas of practice, but there is limited information about its effect in the cancer clinical trial setting, particularly in relation to consent rates. In this study, 173 patients were randomised to receive either the AVPI, in addition to the standard trial-specific written information, or the written information alone. There was no difference in clinical trial recruitment rates between the two groups with similar study entry rates: 72.1% in the AVPI group and 75.9% in the standard information group. The estimated odds ratio for refusal (intervention/no intervention) was 1.19 (95% CI 0.55 -2.58, P ¼ 0.661). Knowledge scores increased more in the AVPI group compared to the standard group (P ¼ 0.0072). The change in anxiety score between the arms was also statistically significant (P ¼ 0.011) with anxiety improving in the intervention arm more than in the no intervention arm. Audiovisual patient information was shown to be a useful tool in improving patient knowledge and anxiety, but further work is necessary in relation to its effect on clinical trial recruitment rates.

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Section: Clinical Trials and Recruitmentmentioning

confidence: 99%

A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials

et al. 2007

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“…Historically, many barriers have been described in recruiting individuals from ethnic minorities into clinical research (25)(26)(27)(28).…”

Section: Factors Associated With Missing Datamentioning

confidence: 99%

Enrollment in a Brain Magnetic Resonance Study: Results From the Women’s Health Initiative Memory Study Magnetic Resonance Imaging Study (WHIMS-MRI)

et al. 2007

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Rationale and Objectives-The rates of enrollment of volunteers for brain magnetic resonance imaging (MRI) studies vary by demographic and clinical characteristics. We use data from a large MRI study to identify factors associated with differential enrollment and to examine potential biases this may produce in study results.Materials and Methods-Results from recruitment of 1,431 women into the MRI substudy of the Women's Health Initiative Memory Study (WHIMS-MRI) are described. A sensitivity analysis was conducted to estimate the degree of bias associated with missing data on estimates of risk factor relationships.Results-Of 2,345 women contacted from an established cohort of women older than 70 years of age, 72% consented to undergo screening for WHIMS-MRI. Scanning was ultimately completed on 61%. Completion rates varied according to a range of sociodemographic, lifestyle, and clinical characteristics that may be related to study outcomes. Plausible levels of selective enrollment in magnetic resonance imaging studies may produce moderate biases (< ±20%) in characterizations of risk factor relationships. Adverse events, such as claustrophobia, occurred during 1.7% of the attempted scans and, in 0.8% of instances, led to lost data.Conclusions-Enrollment of older women into brain imaging studies is feasible, although selection biases may limit how well study cohorts reflect more general populations.

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“…Increasingly, attention is being paid to the barriers to participation that physicians and healthcare systems create as well. 7,8 It is likely that successful recruitment strategies will feature versatile, dynamic, and multidisciplinary approaches that ultimately link women with investigators by overcoming these common barriers.…”

Section: Introductionmentioning

confidence: 99%

Recruitment of Women Research Participants: The Women's Health Registry at the University of Michigan

Rogers

Johnson

Brown

et al. 2007

Journal of Women's Health

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Objective: The goal was to develop the Women's Health Registry, a research participant database that prospectively collects detailed information on potential research subjects to assist in linking them with open research protocols and to assess investigator use and satisfaction with this Registry. Methods:The Women's Health Registry was launched in 1999. Women aged ≥18 years were recruited to enroll in a database of women with interest in research participation and to complete a health questionnaire. Women's health researchers with IRB-approved projects were encouraged to apply for access to the Registry participants. In 2003, the first 15 investigators to use the Women's Health Registry were asked to participate in a standardized open-ended interview to assess investigator satisfaction with this recruitment tool.Results: The Women's Health Registry is currently populated with 2436 women: 36.8% aged 18-34, 39.9% aged 35-54, 16.8% aged 55-69, and 6.4% aged ≥70 years. Of these women, 84% are Caucasian and 8.5% are African American. Structured interviews with 13 of the 15 investigators contacted revealed that 36.4% of the total subject enrollment recruited by these investigators was recruited from the Women's Health Registry. In addition, Registry participants were more likely to enroll in their research protocols than women contacted through other methods. Most of the investigators' expectations from the Women's Health Registry were met, except for access to menopausal women. Conclusions:The Women's Health Registry was successfully developed, and the goal of linking women with appropriate protocols was met with significant investigator satisfaction.

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Recruitment for controlled clinical trials: Literature summary and annotated bibliography

Cited by 369 publications

References 68 publications

A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials

A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials

Enrollment in a Brain Magnetic Resonance Study: Results From the Women’s Health Initiative Memory Study Magnetic Resonance Imaging Study (WHIMS-MRI)

Recruitment of Women Research Participants: The Women's Health Registry at the University of Michigan

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