A systematic review of models to predict recruitment to multicentre clinical trials.
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ABSTRACT:
SUBMITTER: Barnard KD
PROVIDER: S-EPMC2908107 | biostudies-literature | 2010
REPOSITORIES: biostudies-literature
Publications
A systematic review of models to predict recruitment to multicentre clinical trials.
Barnard Katharine D KD Dent Louise L Cook Andrew A
BMC medical research methodology 20100706
<h4>Background</h4>Less than one third of publicly funded trials managed to recruit according to their original plan often resulting in request for additional funding and/or time extensions. The aim was to identify models which might be useful to a major public funder of randomised controlled trials when estimating likely time requirements for recruiting trial participants. The requirements of a useful model were identified as usability, based on experience, able to reflect time trends, accounti ...[more]
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Project description:BackgroundRecruitment for clinical trials continues to be a challenge, as patient recruitment is the single biggest cause of trial delays. Around 80% of trials fail to meet the initial enrollment target and timeline, and these delays can result in lost revenue of as much as US $8 million per day for drug developing companies.ObjectiveThis study aimed to conduct a systematic review and meta-analysis examining the effectiveness of online recruitment of participants for clinical trials compared with traditional in-clinic/offline recruitment methods.MethodsData on recruitment rates (the average number of patients enrolled in the study per month and per day of active recruitment) and conversion rates (the percentage of participants screened who proceed to enroll into the clinical trial), as well as study characteristics and patient demographics were collected from the included studies. Differences in online and offline recruitment rates and conversion rates were examined using random effects models. Further, a nonparametric paired Wilcoxon test was used for additional analysis on the cost-effectiveness of online patient recruitment. All data analyses were conducted in R language, and P<.05 was considered significant.ResultsIn total, 3861 articles were screened for inclusion. Of these, 61 studies were included in the review, and 23 of these were further included in the meta-analysis. We found online recruitment to be significantly more effective with respect to the recruitment rate for active days of recruitment, where 100% (7/7) of the studies included had a better online recruitment rate compared with offline recruitment (incidence rate ratio [IRR] 4.17, P=.04). When examining the entire recruitment period in months we found that 52% (12/23) of the studies had a better online recruitment rate compared with the offline recruitment rate (IRR 1.11, P=.71). For cost-effectiveness, we found that online recruitment had a significantly lower cost per enrollee compared with offline recruitment (US $72 vs US $199, P=.04). Finally, we found that 69% (9/13) of studies had significantly better offline conversion rates compared with online conversion rates (risk ratio 0.8, P=.02).ConclusionsTargeting potential participants using online remedies is an effective approach for patient recruitment for clinical research. Online recruitment was both superior in regard to time efficiency and cost-effectiveness compared with offline recruitment. In contrast, offline recruitment outperformed online recruitment with respect to conversion rate.
| S-EPMC7673977 | biostudies-literature
Project description:ObjectivesTo identify studies that applied behavioural approaches to issues of recruitment and/or retention to trials; to describe these approaches; and to identify gaps for future research.DesignSystematic mapping review of research undertaken in clinical trials within peer-reviewed sources. Review participants were individuals involved in clinical trials, including trial staff, participants, potential participants and former participants.Data sourcesMEDLINE, EMBASE, CINAHL, ERIC, PsycINFO, Web of Science and ASSIA from inception to 15 January 2020 with no date or language restrictions.Eligibility criteriaStudies within the context of clinical trials reporting the barriers/facilitators to recruitment and retention, or developing/evaluating solutions to said barriers/facilitators, using a behavioural approach.Results31 articles were included. Recruitment-focused studies (n=22, 71%) represented the majority. Studies tended to focus on participant behaviours (n=22, 71%). Underserved populations (n=11, 35%) were a notable subset of studies. Most studies (n=23, 74%) were exploratory but those that evaluated interventions (n=8, 26%) often did so within underserved populations (n=6). A majority of studies (n=30, 97%) did not specify their behaviours consistent with guidelines from behavioural scientists. The most used approaches were social cognitive theory (n=8, 26%), the theory of planned behaviour (n=6, 19%) and the theoretical domains framework (n=5, 16%).ConclusionsA range of behavioural approaches have been applied to recruitment and retention to trials. The multitude of recruitment research here is consistent with trials research generally and emphasises the need for research into retention. Authors report target behaviours minimally, which is not conducive to replication. Further research should build on lessons here, such as clearly specifying behaviours. Increased methodological rigour and transparency will lead to robust evidence bases and less research waste in poor recruitment and retention. Overall, trials informed by behavioural approaches promises to be efficient and more participant focused.
| S-EPMC8915327 | biostudies-literature
Project description:BackgroundRecruitment 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 findingsA 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.ConclusionRecruitment 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.
| S-EPMC2976724 | biostudies-literature
Project description:BackgroundAs well as being a risk factor for cardiovascular disease, hypertension is also a health condition in its own right. Risk prediction models may be of value in identifying those individuals at risk of developing hypertension who are likely to benefit most from interventions.Methods and findingsTo synthesize existing evidence on the performance of these models, we searched MEDLINE and EMBASE; examined bibliographies of retrieved articles; contacted experts in the field; and searched our own files. Dual review of identified studies was conducted. Included studies had to report on the development, validation, or impact analysis of a hypertension risk prediction model. For each publication, information was extracted on study design and characteristics, predictors, model discrimination, calibration and reclassification ability, validation and impact analysis. Eleven studies reporting on 15 different hypertension prediction risk models were identified. Age, sex, body mass index, diabetes status, and blood pressure variables were the most common predictor variables included in models. Most risk models had acceptable-to-good discriminatory ability (C-statistic>0.70) in the derivation sample. Calibration was less commonly assessed, but overall acceptable. Two hypertension risk models, the Framingham and Hopkins, have been externally validated, displaying acceptable-to-good discrimination, and C-statistic ranging from 0.71 to 0.81. Lack of individual-level data precluded analyses of the risk models in subgroups.ConclusionsThe discrimination ability of existing hypertension risk prediction tools is acceptable, but the impact of using these tools on prescriptions and outcomes of hypertension prevention is unclear.
| S-EPMC3702558 | biostudies-literature
Project description:BackgroundRecruitment and retention challenges are very common in mental health randomised trials. Investigators utilise different methods to improve recruitment or retention. However, evidence of the effectiveness and efficiency of these strategies in mental health has not been synthesised. This systematic review is to investigate and assess the effectiveness and cost-effectiveness of different strategies to improve recruitment and retention in mental health randomised trials.Methods and materialsMEDLINE, EMBASE, the Cochrane Methodology Register and PsycINFO were searched from beginning of record up to July 2016. Randomised trials involving participants with mental health problems which compared different strategies for recruitment or retention were selected. Two authors independently screened identified studies for eligibility.ResultsA total of 5,157 citations were identified. Thirteen articles were included, 11 on recruitment and 2 on retention. Three randomised controlled trials compared different recruitment strategies, none of which found statistically significant differences between the interventional recruitment strategies and the routine recruitment methods. Retrospective comparisons of recruitment methods showed that non-web-based advertisement and recruitment by clinical research staff each have advantages in efficiency. Web-based adverts had the lowest cost per person recruited (£13.41 per person recruited). Specialised care referral cost £183.24 per person, non-web-based adverts cost £372.03 per patient and recruitment via primary care cost £407.65 for each patient. Financial incentives, abridged questionnaires and pre-notification had a positive effect on retention rates.ConclusionThe recruitment studies included showed differences in strategies, clinical settings, mental health conditions and study design. It is difficult to assess the overall effectiveness of any particular recruitment strategy as some strategies that worked well for a particular population may not work as well for others. Paying attention to the accessibility of information and consent materials may help improve recruitment. More research in this area is needed given its important implications.
| S-EPMC6114918 | biostudies-literature
Project description:BackgroundThere is little evidence on the accuracy of psychosis relapse prediction models. Our objective was to undertake a systematic review of relapse prediction models in psychosis.MethodWe conducted a literature search including studies that developed and/or validated psychosis relapse prediction models, with or without external model validation. Models had to target people with psychosis and predict relapse. The key databases searched were; Embase, Medline, Medline In-Process Citations & Daily Update, PsychINFO, BIOSIS Citation Index, CINAHL, and Science Citation Index, from inception to September 2016. Prediction modelling studies were assessed for risk of bias and applicability using the PROBAST tool.ResultsThere were two eligible studies, which included 33,088 participants. One developed a model using prodromal symptoms and illness-related variables, which explained 14% of relapse variance but was at high risk of bias. The second developed a model using administrative data which was moderately discriminative (C = 0.631) and associated with relapse (OR 1.11 95% CI 1.10, 1.12) and achieved moderately discriminative capacity when validated (C = 0.630). The risk of bias was low.ConclusionsDue to a lack of high quality evidence it is not possible to make any specific recommendations about the predictors that should be included in a prognostic model for relapse. For instance, it is unclear whether prodromal symptoms are useful for predicting relapse. The use of routine data to develop prediction models may be a more promising approach, although we could not empirically compare the two included studies.
| S-EPMC5608199 | biostudies-literature
Project description: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. Data sources A systematic review of English and non-English articles identified from: The Cochrane Library, Ovid MEDLINE, Ovid EMBASE, Ovid PsycINFO, Ebsco CINAHL, Index to Theses and Open SIGLE from 2001 to March 2011. Additional reports were identified through citation searches of included articles. 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, patient-clinician 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 the use of qualitative methods to identify and overcome barriers to clinician recruitment activity. More good quality studies of interventions are needed to add to the evidence base. The metasummary of qualitative findings identified understanding and communicating RCT methods as a key target for future interventions to improve recruitment. Reinforcement of the potential benefits, both for clinicians and for their patients, could also be a successful factor in improving recruitment. A bias was found towards investigating barriers to recruitment, so future work should also encompass a focus on successfully recruiting trials.
| S-EPMC3253423 | biostudies-literature
Project description:Practical clinical trials (PCTs) are randomized experiments under typical practice conditions with the aim of testing the "real-life" benefits and risks of therapeutic interventions. Influential PCTs have been conducted in cardiology, oncology, and internal medicine. Psychotropic medications are widely and increasingly used in medical practice. This review examines recent progress in conducting PCTs in psychopharmacology. The January 2000 to October 2014 MEDLINE, Scopus, and ClinicalTrials.gov databases were searched for peer-reviewed publications of PCTs with at least 100 subjects per treatment arm. Most PCTs in psychiatry evaluated mental health services or psychosocial interventions rather than specific pharmacotherapies. Of 157 PCTs in psychiatry, 30 (19%) were in psychopharmacology, with a median of 2 publications per year and no increase during the period of observation. Sample size ranged from 200 to 18,154; only 11 studies randomized 500 patients or more. Psychopharmacology PCTs were equally likely to be funded by industry as by public agencies. There were 10 PCTs of antidepressants, for a total of 4206 patients (in comparison with at least 46 PCTs of antihypertensive medications, for a total of 208,014 patients). Some psychopharmacology PCTs used suicidal behavior, treatment discontinuation, or mortality as primary outcome and produced effectiveness and safety data that have influenced both practice guidelines and regulatory decisions. Practical clinical trials can constitute an important source of information for clinicians, patients, regulators, and policy makers but have been relatively underused in psychopharmacology. Electronic medical records and integrated practice research networks offer promising platforms for a more efficient conduct of PCTs.
| S-EPMC4427905 | biostudies-literature
Project description:ObjectiveThe aim of this study was to examine the efficacy, safety and dosing practices of rimabotulinumtoxinB (BoNT-B) for the treatment of patients with sialorrhea based on a systematic review of clinical trials.MethodsA systematic literature review was performed to identify randomized controlled trials and other comparative clinical studies of BoNT-B for the treatment of sialorrhea published in English between January 1999 and December 2015. Medical literature databases (PubMed, Cochrane Library, and EMBASE) were searched and a total of 41 records were identified. Of these, six primary publications that evaluated BoNT-B for the treatment of sialorrhea met criteria and were included in the final data report.SynthesisTotal BoNT-B doses ranged from 1500 to 4000 units for sialorrhea. Most of the studies in sialorrhea showed statistically significant benefits of BoNT-B versus placebo (range 4-19.2 weeks). BoNT-B was generally well tolerated across the individual studies; most adverse events reported were considered unrelated to treatment. Adverse events considered potentially associated with BoNT-B included: dry mouth, change in saliva thickness, mild transient dysphagia, mild weakness of chewing and diarrhea.ConclusionsBoNT-B significantly reduces sialorrhea at doses between 1500 and 4000 units. The relatively mild dose-dependent adverse events suggest both direct and remote toxin effects.
| S-EPMC5460542 | biostudies-literature
Project description:There is urgent need for clinical trials of novel interventions to reduce the burden of acute ischemic stroke. A key impediment to such trials is slow recruitment. Since obtaining written informed consent in the setting of acute stroke is especially challenging, some experts have endorsed relaxing the requirement for informed consent by permitting verbal consent or waivers to facilitate recruitment. This systematic review of 36 randomized controlled trials of acute interventions for ischemic stroke assesses whether alternatives to written informed consent are associated with increased recruitment rates. After the exclusion of 2 outlier trials that differed from other trials in conduct and interventions studied, no association was observed on univariable analysis (8.9 participants/month in trials requiring written consent vs 6.1 participants/month in trials with alternatives, p = 0.43) or multivariable analysis (when adjusting for the number of centers, number of countries, and exclusions based on modified Rankin Scale scores). Alternatives to written informed consent in acute stroke trials may enable trial designs that would not be feasible otherwise. However, we did not find evidence that, within traditional trial designs, such alternatives are associated with faster recruitment.
| S-EPMC4836887 | biostudies-literature