Recruitment, Retention, and Blinding in Clinical Trials

Page, Stephen J.; Persch, Andrew

doi:10.5014/ajot.2013.006197

Cited by 106 publications

(97 citation statements)

References 19 publications

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“…The inconsistency in providing sample size calculation should also be pointed out here. Furthermore, the study by Brahe et al [38] only used a single-blind method, which may increase the likelihood of bias [72].…”

Section: Discussionmentioning

confidence: 99%

Probiotic Foods and Supplements Interventions for Metabolic Syndromes: A Systematic Review and Meta-Analysis of Recent Clinical Trials

Dong

Chen

et al. 2019

Ann Nutr Metab

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Background: Individual clinical trials suggested that when treated with probiotic foods or supplements with Lactobacillus and Bifidobacterium, specific symptoms of metabolic syndrome (MetS) could be alleviated, but the results have been inconclusive. Aims: The objective of the present meta-analysis was to use anthropometric and biochemical as indicators to evaluate the efficacy of using these probiotic foods or supplements among individuals with MetS. Methods: PubMed, Cochrane Library, and CINAHL Plus were used to collect randomized controlled trials (RCTs) studies published from January 2000 to January 2018. Studies were included if they had at least one of the following outcome measurements: body mass index (BMI), waist circumference, hip circumference, waist-to-hip ratio, body fat mass (BFM), body fat percentage (BFP), systolic blood pressure (SBP), diastolic blood pressure (DBP), fasting glucose, fasting insulin, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides, and/or hemoglobin A1c (HbA1c). Results: The 356 records were identified during the literature search, of which only 18 met the selection criteria. The 18 RCTs with a total of 1,544 participants were included in this analysis. This meta-analysis indicated that there were no significant differences of BMI, BFM, waist circumference, hip circumference, waist-to-hip ratio, SBP, DBP, fasting glucose, fasting insulin, TC, HDL-C, HbA1c, or triglycerides between the intervention and control groups. Significant standardized mean net differences were found in the BFP and LDL-C between the intervention and control groups. Conclusions: The results indicated that probiotic food and supplement with Lactobacillus and Bifidobacterium could be used as interventions to improve specific anthropometric and biochemical outcomes among individuals with MetS. However, probiotic treatment alone could not reduce overall health risks. In addition, there were methodological drawbacks among reviewed studies, and further research is needed.

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Section: Discussionmentioning

confidence: 99%

Probiotic Foods and Supplements Interventions for Metabolic Syndromes: A Systematic Review and Meta-Analysis of Recent Clinical Trials

Dong

Chen

et al. 2019

Ann Nutr Metab

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“…As other researchers have pointed out, taking a multipronged approach over the course of the enrollment phase has the greatest impact and we have seen that approach confirmed in PPMI [3]. At any given time, sites were holding events to inform local physicians of the study to seek referrals from these clinics.…”

Section: Resultsmentioning

confidence: 80%

Improving patient participation in Parkinson‘s clinical trials: the experience of the Michael J Fox Foundation

Chowdhury¹,

Meunier²,

Cappelletti³

et al. 2014

Clinical Investigation

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Timely and efficient clinical trial recruitment is a chronic problem across diseases. The Michael J Fox Foundation for Parkinson's Research (MJFF) is a leading funder and sponsor of Parkinson's disease research. Solving recruitment challenges in Parkinson's disease is a priority for the MJFF and led to the development of an online tool -Fox Trial Finder -that connects participants to trials. As the sponsor of the Parkinson's Progression Markers Initiative, an observational biomarkers study, the MJFF developed first-hand expertise in recruitment planning and tactical implementation.Solving poor enrollment relies on all stakeholders involved -sponsors, funders, site personnel and patients -to work together to raise awareness of the problem and implement strategies to increase the number of people who participate in research.

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“…The term passive recruiting strategies refers to strategies in which the research team makes an initial effort to gain participants' attention (e.g., study advertisement), but the onus is largely on the participant to take action [42]. In this view, computer-based platforms may play a role in recruitment.…”

Section: Passive and Active Recruitmentmentioning

confidence: 98%

Recruitment strategies and patient selection in clinical trials for Parkinson's disease: Going viral and keeping science and ethics at the highest standards

Picillo

Kou

Barone

et al. 2015

Parkinsonism & Related Disorders

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Recruitment, Retention, and Blinding in Clinical Trials

Cited by 106 publications

References 19 publications

Probiotic Foods and Supplements Interventions for Metabolic Syndromes: A Systematic Review and Meta-Analysis of Recent Clinical Trials

Probiotic Foods and Supplements Interventions for Metabolic Syndromes: A Systematic Review and Meta-Analysis of Recent Clinical Trials

Improving patient participation in Parkinson‘s clinical trials: the experience of the Michael J Fox Foundation

Recruitment strategies and patient selection in clinical trials for Parkinson's disease: Going viral and keeping science and ethics at the highest standards

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