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Do variations in allocation concealment methods influence the effects found in intervention reviews?

Naing C, Hasan SS, Aung K

J Evid Based Med, 2011 Nov;4(4):255-8.
PMID: 23672756 DOI: 10.1111/j.1756-5391.2011.01156.x

(i) To explore any discrepancies in intervention effects between a set of Cochrane reviews that includes trials with liberal criteria and a set with restrictive criteria in which trials with liberal design have been removed from the review, and (ii) to suggest ways to improve the quality of evidence.

Matched MeSH terms: Clinical Trials as Topic/standards*
Fulltext Good clinical practice: issues and challenges

Merican MI

Med J Malaysia, 2000 Jun;55(2):159-63.
PMID: 19839142
Matched MeSH terms: Clinical Trials as Topic/standards*
Garlic supplementation and serum cholesterol: a meta-analysis

Khoo YS, Aziz Z

J Clin Pharm Ther, 2009 Apr;34(2):133-45.
PMID: 19250134 DOI: 10.1111/j.1365-2710.2008.00998.x

Prevention of cardiovascular disease by modifying its major risk factors, including serum cholesterol levels, is an important strategy. Regular intake of garlic has been suggested, but its impact on cholesterol levels has been inconsistent.

Matched MeSH terms: Clinical Trials as Topic/standards
Clinical trials among Arab diabetic patients; the challenges

Mikhael EM, Hassali MA, Hussain SA

Diabetes Metab Syndr, 2019 11 21;14(1):1.
PMID: 31805470 DOI: 10.1016/j.dsx.2019.11.011
Matched MeSH terms: Clinical Trials as Topic/standards*
Fulltext The COMiT'ID Study: Developing Core Outcome Domains Sets for Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults

Hall DA, Smith H, Hibbert A, Colley V, Haider HF, Horobin A, et al.

Trends Hear, 2018;22:2331216518814384.
PMID: 30488765 DOI: 10.1177/2331216518814384

Subjective tinnitus is a chronic heterogeneous condition that is typically managed using intervention approaches based on sound devices, psychologically informed therapies, or pharmaceutical products. For clinical trials, there are currently no common standards for assessing or reporting intervention efficacy. This article reports on the first of two steps to establish a common standard, which identifies what specific tinnitus-related complaints ("outcome domains") are critical and important to assess in all clinical trials to determine whether an intervention has worked. Using purposive sampling, 719 international health-care users with tinnitus, health-care professionals, clinical researchers, commercial representatives, and funders were recruited. Eligibility was primarily determined by experience of one of the three interventions of interest. Following recommended procedures for gaining consensus, three intervention-specific, three-round, Delphi surveys were delivered online. Each Delphi survey was followed by an in-person consensus meeting. Viewpoints and votes involved all stakeholder groups, with approximately a 1:1 ratio of health-care users to professionals. "Tinnitus intrusiveness" was voted in for all three interventions. For sound-based interventions, the minimum set included "ability to ignore," "concentration," "quality of sleep," and "sense of control." For psychology-based interventions, the minimum set included "acceptance of tinnitus," "mood," "negative thoughts and beliefs," and "sense of control." For pharmacology-based interventions, "tinnitus loudness" was the only additional core outcome domain. The second step will next identify how those outcome domains should best be measured. The uptake of these intervention-specific standards in clinical trials will improve research quality, enhance clinical decision-making, and facilitate meta-analysis in systematic reviews.

Matched MeSH terms: Clinical Trials as Topic/standards*
Fulltext Quality of adverse event reporting in clinical trials of remdesivir in patients with COVID-19

Kow CS, Aldeyab M, Hasan SS

Eur J Clin Pharmacol, 2021 Mar;77(3):435-437.
PMID: 33011825 DOI: 10.1007/s00228-020-03008-6
Matched MeSH terms: Clinical Trials as Topic/standards*
Identifying critically important vascular access outcomes for trials in haemodialysis: an international survey with patients, caregivers and health professionals

Viecelli AK, Howell M, Tong A, Teixeira-Pinto A, O'Lone E, Ju A, et al.

Nephrol Dial Transplant, 2020 04 01;35(4):657-668.
PMID: 31369099 DOI: 10.1093/ndt/gfz148

BACKGROUND: Vascular access outcomes reported across haemodialysis (HD) trials are numerous, heterogeneous and not always relevant to patients and clinicians. This study aimed to identify critically important vascular access outcomes.
METHOD: Outcomes derived from a systematic review, multi-disciplinary expert panel and patient input were included in a multilanguage online survey. Participants rated the absolute importance of outcomes using a 9-point Likert scale (7-9 being critically important). The relative importance was determined by a best-worst scale using multinomial logistic regression. Open text responses were analysed thematically.
RESULTS: The survey was completed by 873 participants [224 (26%) patients/caregivers and 649 (74%) health professionals] from 58 countries. Vascular access function was considered the most important outcome (mean score 7.8 for patients and caregivers/8.5 for health professionals, with 85%/95% rating it critically important, and top ranked on best-worst scale), followed by infection (mean 7.4/8.2, 79%/92% rating it critically important, second rank on best-worst scale). Health professionals rated all outcomes of equal or higher importance than patients/caregivers, except for aneurysms. We identified six themes: necessity for HD, applicability across vascular access types, frequency and severity of debilitation, minimizing the risk of hospitalization and death, optimizing technical competence and adherence to best practice and direct impact on appearance and lifestyle.
CONCLUSIONS: Vascular access function was the most critically important outcome among patients/caregivers and health professionals. Consistent reporting of this outcome across trials in HD will strengthen their value in supporting vascular access practice and shared decision making in patients requiring HD.

Matched MeSH terms: Clinical Trials as Topic/standards*
Fulltext Development of standard clinical endpoints for use in dengue interventional trials

Tomashek KM, Wills B, See Lum LC, Thomas L, Durbin A, Leo YS, et al.

PLoS Negl Trop Dis, 2018 10;12(10):e0006497.
PMID: 30286085 DOI: 10.1371/journal.pntd.0006497

Dengue is a major public health problem worldwide. Although several drug candidates have been evaluated in randomized controlled trials, none has been effective and at present, early recognition of severe dengue and timely supportive care are used to reduce mortality. While the first dengue vaccine was recently licensed, and several other candidates are in late stage clinical trials, future decisions regarding widespread deployment of vaccines and/or therapeutics will require evidence of product safety, efficacy and effectiveness. Standard, quantifiable clinical endpoints are needed to ensure reproducibility and comparability of research findings. To address this need, we established a working group of dengue researchers and public health specialists to develop standardized endpoints and work towards consensus opinion on those endpoints. After discussion at two working group meetings and presentations at international conferences, a Delphi methodology-based query was used to finalize and operationalize the clinical endpoints. Participants were asked to select the best endpoints from proposed definitions or offer revised/new definitions, and to indicate whether contributing items should be designated as optional or required. After the third round of inquiry, 70% or greater agreement was reached on moderate and severe plasma leakage, moderate and severe bleeding, acute hepatitis and acute liver failure, and moderate and severe neurologic disease. There was less agreement regarding moderate and severe thrombocytopenia and moderate and severe myocarditis. Notably, 68% of participants agreed that a 50,000 to 20,000 mm3 platelet range be used to define moderate thrombocytopenia; however, they remained divided on whether a rapid decreasing trend or one platelet count should be case defining. While at least 70% agreement was reached on most endpoints, the process identified areas for further evaluation and standardization within the context of ongoing clinical studies. These endpoints can be used to harmonize data collection and improve comparability between dengue clinical trials.

Matched MeSH terms: Clinical Trials as Topic/standards