Impact of on-site initiation visits on patient recruitment and data quality                 in a randomized trial of adjuvant chemotherapy for breast cancer

Liénard, J-L; Quinaux, Emmanuel; Fabre-Guillevin, Élizabeth; Piedbois, Pascal; Jouhaud, A.; Decoster, G.; Buyse, Marc

doi:10.1177/1740774506070807

Cited by 44 publications

(48 citation statements)

References 18 publications

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“…Two studies compared clinicians (nurses vs surgeons; community vs university medical practices) 23 30. Two studies assessed the effect of extra involvement of trial coordinators with clinicians (extra communication; on-site initiation visits) 24 25. One study assessed the effect of change to training and paying for protected research time on recruitment 29…”

Section: Resultsmentioning

confidence: 99%

Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review

et al. 2012

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Background: Poor recruitment to randomised controlled trials (RCTs) is a widespread problem. Provision of interventions aimed at supporting or incentivising clinicians may improve recruitment to RCTs.Objectives: To quantify the effects of strategies aimed at improving the recruitment activity of clinicians in RCTs, complemented with a synthesis of qualitative evidence related to clinicians' attitudes towards recruiting to RCTs. Study eligibility criteria: Quantitative studies were included if they evaluated interventions aimed at improving the recruitment activity of clinicians or compared recruitment by different groups of clinicians. Information about host trial, study design, participants, interventions, outcomes and host RCT was extracted by one researcher and checked by another. Studies that met the inclusion criteria were assessed for quality using a standardised tool, the Effective Public Health Practice Project tool. Qualitative studies were included if they investigated clinicians' attitudes to recruiting patients to RCTs. All results/findings were extracted, and content analysis was carried out. Overarching themes were abstracted, followed by a metasummary analysis. Studies that met the inclusion criteria were assessed for quality using the Critical Appraisal Skills Programme qualitative checklist.Data extraction: Data extraction was carried out by one researcher using predefined data fields, including study quality indicators, and verified by another.Results: Eight quantitative studies were included describing four interventions and a comparison of recruiting clinicians. One study was rated as strong, one as moderate and the remaining six as weak when assessed for quality using the Effective Public Health Practice Project tool. Effective interventions included the use of qualitative research to identify and overcome barriers to recruitment, reduction of the clinical workload associated with participation in RCTs and the provision of extra training and protected research time. Eleven qualitative studies were identified, and eight themes were abstracted from the data: understanding of research, communication, perceived patient barriers, patienteclinician relationship, effect on patients, effect on clinical practice, individual benefits for clinicians and methods associated with successful recruitment. Metasummary analysis identified the most frequently reported subthemes to be: difficulty communicating trial methods, poor understanding of research and priority given to patient well-being. Overall, the qualitative studies were found to be of good quality when assessed using the Critical Appraisal Skills Programme checklist.Conclusions: There were few high-quality trials that tested interventions to improve clinicians' recruitment activity in RCTs. The most promising intervention was ARTICLE SUMMARYArticle focus -A systematic review to identify and synthesise evidence of evaluations of interventions aimed at improving clinician recruitment activity in RCTs, and evidence of clinicians' attitudes t...

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Section: Resultsmentioning

confidence: 99%

Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review

et al. 2012

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“…Excessive site monitoring was identified as a barrier to reform [3], although the conference-endorsed monitoring aimed at detecting procedural errors that could compromise patient safety or bias outcome data (essential for unblinded trials) [24]. Furthermore, the conference proposed that site monitoring should focus on training and enthusing staff, solving problems, assessing protocol adherence, and checking resources [24], all elements of the PRIME system. These wider aims for site monitoring were supported by results from the Women's Health Initiative trial, where sites with low staff turnover had higher follow-up rates [25].…”

Section: Discussionmentioning

confidence: 99%

“…Developments to tailor site monitoring to the needs of the trial based on the risks to patient safety and data are currently under investigation [12]. Techniques for remote statistical monitoring are also being developed [24] and are used by some academic trial units to replace site visits [15]. Intensive site monitoring systems can be costly [3,26], and a simulation model estimated that the costs of an industry-designed IMP trial could be nearly halved by reducing the CRF length and site monitoring frequency by up to 75% [27].…”

Section: Discussionmentioning

confidence: 99%

A Peer Review Intervention for Monitoring and Evaluating sites (PRIME) that improved randomized controlled trial conduct and performance

Lane¹,

Wade²,

Down³

et al. 2011

Journal of Clinical Epidemiology

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“…A recent randomized trial showed that systematic center initiation visits (without qualitative research) did not improve recruitment or randomization [14]. The centers reviewed in this study were fully compliant with Good Clinical Practice according to the audit of consent procedures, but the qualitative research identified aspects of study information and presentation that could be improved to ensure better informed consent and high levels of randomization.…”

Section: Box 3 Examples Of Poor Descriptions Of Randomizationmentioning

confidence: 96%

Development of a complex intervention improved randomization and informed consent in a randomized controlled trial

Donovan

Lane

Peters

et al. 2009

Journal of Clinical Epidemiology

137

186

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Impact of on-site initiation visits on patient recruitment and data quality in a randomized trial of adjuvant chemotherapy for breast cancer

Abstract: Systematic on-site initiation visits did not contribute significantly to this clinical trial.

Cited by 44 publications

References 18 publications

Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review

Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review

A Peer Review Intervention for Monitoring and Evaluating sites (PRIME) that improved randomized controlled trial conduct and performance

Development of a complex intervention improved randomization and informed consent in a randomized controlled trial

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