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N-of-1 Randomized Intervention Trials in Health Psychology: A Systematic Review and Methodology Critique.

ABSTRACT: Background:Single-patient, multiple cross-over designs (N-of-1 or single-case randomized clinical trials) with systematic data collection on treatment effects may be useful for increasing the precision of treatments in health psychology. Purposes:To assess the quality of the methods and statistics, describe interventions and outcomes, and explore the heterogeneity of treatment effect of health psychology N-of-1 trials. Methods:We conducted a systematic review of N-of-1 trials from electronic database inception through June 1, 2015. Potentially relevant articles were identified by searching the biomedical electronic databases Ovid, MEDLINE, EMBASE, all six databases in the Cochrane Library, CINAHL, and PsycINFO, and conference proceedings, dissertations, ongoing studies, Open Grey, and the New York Academy's Grey Literature Report. Studies were included if they had health behavior or psychological outcomes and the order of interventions was randomized. We abstracted study characteristics and analytic methods and used the Consolidated Standards of Reporting Trials extension for reporting N-of-1 trials as a quality checklist. Results:Fifty-four N-of-1 trial publications composed of 1,193 participants were included. Less than half of these (36%) reported adequate information to calculate the heterogeneity of treatment effect. Nearly all (90%) provided some quantitative information to determine the superior treatment; 79% used an a priori statistical cutoff, 12% used a graph, and 10% used a combination. Conclusions:N-of-1 randomized trials could be the next major advance in health psychology for precision therapeutics. However, they must be conducted with more methodologic and statistical rigor and must be transparently and fully reported.

SUBMITTER: Shaffer JA

PROVIDER: S-EPMC6128372 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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N-of-1 Randomized Intervention Trials in Health Psychology: A Systematic Review and Methodology Critique.

Shaffer Jonathan A JA Kronish Ian M IM Falzon Louise L Cheung Ying Kuen YK Davidson Karina W KW

Annals of behavioral medicine : a publication of the Society of Behavioral Medicine 20180801 9

<h4>Background</h4>Single-patient, multiple cross-over designs (N-of-1 or single-case randomized clinical trials) with systematic data collection on treatment effects may be useful for increasing the precision of treatments in health psychology.<h4>Purposes</h4>To assess the quality of the methods and statistics, describe interventions and outcomes, and explore the heterogeneity of treatment effect of health psychology N-of-1 trials.<h4>Methods</h4>We conducted a systematic review of N-of-1 tria ...[more]

PMID: 30124759

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Project description:OBJECTIVES:To explore the commonly utilized sham acupressure procedures in existing acupressure trials, and to assess whether different types of sham interventions yield different therapeutic outcomes, and, as far as possible, to identify directions for the future development of an adequate sham acupressure method. METHODS:Randomized controlled trials comparing true acupressure with sham interventions were included. Thirteen electronic databases were adopted to locate relevant studies from inception to July 3, 2014. Meanwhile, eight Chinese journals on complementary and alternative medicine were manually searched to locate eligible articles. In addition, eligible studies listed in the reference lists of the included papers and other related systematic reviews on acupressure were also screened to further search any potentially eligible trials. Methodological quality of the included studies was evaluated using the risk of bias assessment tool developed by the Cochrane Back Review Group. Descriptive analysis was adopted to summarize the therapeutic outcomes. RESULTS:Sixty-six studies with 7265 participants were included. Methodological quality of the included trials was generally satisfactory. Six types of sham acupressure approaches were identified and "non-acupoint" stimulation was the most frequently utilized sham point while an acupressure device was the most commonly used approach for administering sham treatments. Acupressure therapy was a beneficial approach in managing a variety of health problems and the therapeutic effect was found to be more effective in the true acupressure groups than that in the sham comparative groups. No clear association could be identified between different sham acupressure modalities and the reported treatment outcomes. CONCLUSIONS:A great diversity of sham acupressure controls have been used in clinical practice and research. A solid conclusion whether different sham alternatives are related to different treatment outcomes cannot be derived because of significant clinical heterogeneity among the analyzed trials. Non-acupoints are generally recommended but the definite locations should be identified with caution. For studies using single sham acupoints on hands or legs, it is suggested to apply identical acupressure devices on the same acupoint as in the active intervention without any stimulation. While for studies on pain, stimulation of sham acupoints should be avoided.

Project description:BACKGROUND: Although arthroscopy of upper extremity joints was initially a diagnostic tool, it is increasingly used for therapeutic interventions. Randomized controlled trials (RCTs) are considered the gold standard for assessing treatment efficacy. We aimed to review the literature for intervention RCTs involving wrist and shoulder arthroscopy. METHODS: We performed a systematic review for RCTs in which at least one arm was an intervention performed through wrist arthroscopy or shoulder arthroscopy. PubMed and Cochrane Library databases were searched up to December 2012. Two researchers reviewed each article and recorded the condition treated, randomization method, number of randomized participants, time of randomization, outcomes measures, blinding, and description of dropouts and withdrawals. We used the modified Jadad scale that considers the randomization method, blinding, and dropouts/withdrawals; score 0 (lowest quality) to 5 (highest quality). The scores for the wrist and shoulder RCTs were compared with the Mann-Whitney test. RESULTS: The first references to both wrist and shoulder arthroscopy appeared in the late 1970s. The search found 4 wrist arthroscopy intervention RCTs (Kienböck's disease, dorsal wrist ganglia, volar wrist ganglia, and distal radius fracture; first 3 compared arthroscopic with open surgery). The median number of participants was 45. The search found 50 shoulder arthroscopy intervention RCTs (rotator cuff tears 22, instability 14, impingement 9, and other conditions 5). Of these, 31 compared different arthroscopic treatments, 12 compared arthroscopic with open treatment, and 7 compared arthroscopic with nonoperative treatment. The median number of participants was 60. The median modified Jadad score for the wrist RCTs was 0.5 (range 0-1) and for the shoulder RCTs 3.0 (range 0-5) (p = 0.012). CONCLUSION: Despite the increasing use of wrist arthroscopy in the treatment of various wrist disorders the efficacy of arthroscopically performed wrist interventions has been studied in only 4 randomized studies compared to 50 randomized studies of significantly higher quality assessing interventions performed through shoulder arthroscopy.

Project description:BackgroundThe therapeutic evidence collected from well-designed studies is needed to help manage the global pandemic of the coronavirus disease 2019 (COVID-19). Evaluating the quality of therapeutic data collected during this most recent pandemic is important for improving future clinical research under similar circumstances.ObjectiveTo assess the methodological quality and variability in implementation of randomized controlled trials (RCTs) for treating COVID-19, and to analyze the support that should be provided to improve data collected during an urgent pandemic situation.Search strategyPubMed, Excerpta Medica Database, China National Knowledge Infrastructure, Wanfang, and Chongqing VIP, and the preprint repositories including Social Science Research Network and MedRxiv were systematically searched, up to September 30, 2020, using the keywords "coronavirus disease 2019 (COVID-19)," "2019 novel coronavirus (2019-nCoV)," "severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2)," "novel coronavirus pneumonia (NCP)," "randomized controlled trial (RCT)" and "random."Inclusion criteriaRCTs studying the treatment of COVID-19 were eligible for inclusion.Data extraction and analysisScreening of published RCTs for inclusion and data extraction were each conducted by two researchers. Analysis of general information on COVID-19 RCTs was done using descriptive statistics. Methodological quality was assessed using the risk-of-bias tools in the Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1.0). Variability in implementation was assessed by comparing consistency between RCT reports and registration information.ResultsA total of 5886 COVID-19 RCTs were identified. Eighty-one RCTs were finally included, of which, 45 had registration information. Methodological quality of the RTCs was not optimal due to deficiencies in five main domains: allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, and selective reporting. Comparisons of consistency between published protocols and registration information showed that the 45 RCTs with registration information had common deviations in seven items: inclusion and exclusion criteria, sample size, outcomes, research sites of recruitment, interventions, and blinding.ConclusionThe methodological quality of COVID-19 RCTs conducted in early to mid 2020 was consistently low and variability in implementation was common. More support for implementing high-quality methodology is needed to obtain the quality of therapeutic evidence needed to provide positive guidance for clinical care. We make an urgent appeal for accelerating the construction of a collaborative sharing platform and preparing multidisciplinary talent and professional teams to conduct excellent clinical research when faced with epidemic diseases of the future. Further, variability in RCT implementation should be clearly reported and interpreted to improve the utility of data resulting from those trials.

Project description:BackgroundThe purported ergogenic and health effects of probiotics have been a topic of great intrigue among researchers, practitioners, and the lay public alike. There has also been an increased research focus within the realm of sports science and exercise medicine on the athletic gut microbiota. However, compared to other ergogenic aids and dietary supplements, probiotics present unique study challenges. The objectives of this systematic scoping review were to identify and characterize study methodologies of randomized controlled trials investigating supplementation with probiotics in athletes and physically active individuals.MethodsFour databases (MEDLINE, CINAHL, Cochrane CENTRAL, and Cochrane Database of Systematic Reviews) were searched for randomized controlled studies involving healthy athletes or physically active individuals. An intervention with probiotics and inclusion of a control and/or placebo group were essential. Only peer-reviewed articles in English were considered, and there were no date restrictions. Results were extracted and presented in tabular form to detail study protocols, characteristics, and outcomes. Bias in randomized controlled trials was determined with the RoB 2.0 tool.ResultsA total of 45 studies were included in the review, with 35 using a parallel group design and 10 using a cross-over design. Approximately half the studies used a single probiotic and the other half a multi-strain preparation. The probiotic dose ranged from 2 × 108 to 1 × 1011 colony forming units daily, and the length of intervention was between 7 and 150 days. Fewer than half the studies directly assessed gastrointestinal symptoms, gut permeability, or the gut microbiota. The sex ratio of participants was heavily weighted toward males, and only 3 studies exclusively investigated females. Low-level adverse events were reported in only 2 studies, although the methodology of reporting varied widely. The risk of bias was generally low, although details on randomization were lacking in some studies.ConclusionThere is a substantial body of research on the effects of probiotic supplementation in healthy athletes and physically active individuals. Considerable heterogeneity in probiotic selection and dosage as well as outcome measures has made clinical and mechanistic interpretation challenging for both health care practitioners and researchers. Attention to issues of randomization of participants, treatments and interventions, selection of outcomes, demographics, and reporting of adverse events will facilitate more trustworthy interpretation of probiotic study results and inform evidence-based guidelines.

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N-of-1 Randomized Intervention Trials in Health Psychology: A Systematic Review and Methodology Critique.

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N-of-1 Randomized Intervention Trials in Health Psychology: A Systematic Review and Methodology Critique.

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