scholarly journals Use of wearable biometric monitoring devices to measure outcomes in randomized clinical trials: a methodological systematic review

BMC Medicine ◽  
2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Carolina Graña Possamai ◽  
Philippe Ravaud ◽  
Lina Ghosn ◽  
Viet-Thi Tran
Keyword(s):  
Systematic Review ◽  
Randomized Clinical Trials ◽  
Outcome Data ◽  
Pharmacological Intervention ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Outcome Reporting Bias ◽  
Hand Search ◽  
Clinical Trial Registries ◽  
Monitoring Devices

Abstract Background Wearable biometric monitoring devices (BMDs) have the potential to transform the conduct of randomized controlled trials (RCTs) by shifting the collection of outcome data from single measurements at predefined time points to dense continuous measurements. Methods Methodological systematic review to understand how recent RCTs used BMDs to measure outcomes and to describe the reporting of these RCTs. Electronic search was performed in the Cochrane Central Register of Controlled Trials, PubMed, and EMBASE and completed a page-by-page hand search in five leading medical journals between January 1, 2018, and December 31, 2018. Three reviewers independently extracted all primary and secondary outcomes collected using BMDs, and assessed (1) the definitions used to summarize BMD outcome data; (2) whether the validity, reliability, and responsiveness of sensors was reported; (3) the discrepancy with outcomes prespecified in public clinical trial registries; and (4) the methods used to manage missing and incomplete BMD outcome data. Results Of the 4562 records screened, 75 RCTs were eligible. Among them, 24% tested a pharmacological intervention and 57% used an inertial measurement sensor to measure physical activity. Included trials involved 464 outcomes (average of 6 [SD = 8] outcomes per trial). In total, 35 trials used a BMD to measure a primary outcome. Several issues affected the value and transparency of trials using BMDs to measure outcomes. First, the definition of outcomes used in the trials was highly heterogeneous (e.g., 21 diabetes trials had 266 outcomes and 153 had different unique definitions to measure diabetes control), which limited the combination and comparison of results. Second, information on the validity, reliability, and responsiveness of sensors used was lacking in 74% of trials. Third, half (53%) of the outcomes measured with BMDs had not been prespecified, with a high risk of outcome reporting bias. Finally, reporting on the management of incomplete outcome data (e.g., due to suboptimal compliance with the BMD) was absent in 68% of RCTs. Conclusions Use of BMDs to measure outcomes is becoming the norm rather than the exception in many fields. Yet, trialists need to account for several methodological issues when specifying and conducting RCTs using these novel tools.

Clinical, Endoscopic and Histological Outcomes in Induction of Moderate-to-Severe Ulcerative Colitis: A Systematic Review with Meta-Analysis

2020 ◽  
Author(s):  
Fernando Magro ◽  
Maria Manuela Estevinho ◽  
Cláudia Camila Dias ◽  
Luís Correia ◽  
Paula Lago ◽  
...  
Keyword(s):  
Systematic Review ◽  
Ulcerative Colitis ◽  
Assessment Tool ◽  
Meta Analysis ◽  
Pharmacological Intervention ◽  
Controlled Trials ◽  
Significant Heterogeneity ◽  
Cochrane Central Register ◽  
Histological Remission ◽  
The Impact

Abstract Background and Aims Interest in histology for ulcerative colitis [UC] has increased recently. This systematic review and meta-analysis aims to assess, for the first time, whether histological outcomes are more informative than endoscopic and clinical outcomes in distinguishing the impact of intervention over placebo in induction trials. Methods MEDLINE, ScienceDirect and Cochrane Central Register of Controlled Trials were searched to identify randomized placebo-controlled trials [RCTs] enrolling moderate-to-severe UC patients. Studies were assessed using the Quality Assessment Tool for Studies with Diverse Designs. We analysed the pooled proportion of patients achieving clinical, endoscopic and histological remission and response after a pharmacological intervention and compared the results with those of placebo-treated patients by using a random-effects model. Results From 889 identified records, 13 RCTs were included. The odds ratio [OR] for remission was higher in patients receiving intervention than in those under placebo for clinical (OR 2.13, 95% confidence interval [CI] 1.33–3.43), endoscopic [OR 1.46, 95% CI 0.19–11.18] and histological remission [OR 1.85, 95% CI 1.20–2.84]. Significant differences were observed for all response outcomes [clinical: OR 2.27, 95% CI 1.84–2.85; endoscopic: OR 2.16, 95% CI 1.51–3.10; histological: OR 3.63, 95% CI, 1.41–9.36]. No significant heterogeneity existed; no subgroup effects were found for duration of the induction or histological scale [p > 0.05]. Clinical and histological remission and endoscopic response were concordant in discriminating interventions from placebo. Conclusion Histological outcomes are informative in trials of moderate-to-severe UC. Further studies analysing histology at the end of induction are needed to confirm its relevance in distinguishing the efficacy of an intervention over placebo in comparison to clinical and endoscopic outcomes and to explore its prognostic value.

scholarly journals Systematic Review of Randomized Clinical Trials of Acupressure Therapy for Primary Dysmenorrhea

2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Hui-ru Jiang ◽  
Shuang Ni ◽  
Jin-long Li ◽  
Miao-miao Liu ◽  
Ji Li ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Statistical Analysis ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Primary Dysmenorrhea ◽  
Randomized Controlled ◽  
Central Register

The evidence of acupressure is limited in the management of dysmenorrhea. To evaluate the efficacy of acupressure in the treatment of primary dysmenorrhea based on randomized controlled trials (RCTs), we searched MEDLINE, the Chinese Biomedical Database (CBM), and the Cochrane Central Register of Controlled Trials (CENTRAL) databases from inception until March 2012. Two reviewers independently selected articles and extracted data. Statistical analysis was performed with RevMan 5.1 software. Eight RCTs were identified from the retrieved 224 relevant records. Acupressure improved pain measured with VAS (−1.41 cm 95% CI [−1.61, −1.21]), SF-MPQ at the 3-month followup (WMD −2.33, 95% CI [−4.11, −0.54]) and 6-month followup (WMD −4.67, 95% CI [−7.30, −2.04]), and MDQ at the 3-month followup (WMD −2.31, 95% CI [−3.74, −0.87]) and 6-month followup (WMD −4.67, 95% CI [−7.30, −2.04]). All trials did not report adverse events. These results were limited by the methodological flaws of trials.

scholarly journals Randomized Controlled Trials of Early Ambulatory Hydroxychloroquine in the Prevention of COVID-19 Infection, Hospitalization, and Death: Meta-Analysis

2020 ◽  
Author(s):  
Joseph A. Ladapo ◽  
John E. McKinnon ◽  
Peter A. McCullough ◽  
Harvey Risch
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Side Effects ◽  
Fixed Effects ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomized Controlled ◽  
Exposure Prophylaxis

Objective--To determine if hydroxychloroquine (HCQ) reduces the incidence of new illness, hospitalization or death among outpatients at risk for or infected with SARS-CoV-2 (COVID-19). Design--Systematic review and meta-analysis of randomized clinical trials. Data sources--Search of MEDLINE, EMBASE, PubMed, medRxiv, PROSPERO, and the Cochrane Central Register of Controlled Trials. Also review of reference lists from recent meta-analyses. Study selection--Randomized clinical trials in which participants were treated with HCQ or placebo/standard-of-care for pre-exposure prophylaxis, post-exposure prophylaxis, or outpatient therapy for COVID-19. Methods--Two investigators independently extracted data on trial design and outcomes. Medication side effects and adverse reactions were also assessed. The primary outcome was COVID-19 hospitalization or death. When unavailable, new COVID-19 infection was used. We calculated random effects meta-analysis according to the method of DerSimonian and Laird. Heterogeneity between the studies was evaluated by calculation of Cochran Q and I2 parameters. An Egger funnel plot was drawn to investigate publication bias. We also calculated the fixed effects meta-analysis summary of the five studies. All calculations were done in Excel, and results were considered to be statistically significant at a two-sided threshold of P=.05. Results--Five randomized controlled clinical trials enrolling 5,577 patients were included. HCQ was associated with a 24% reduction in COVID-19 infection, hospitalization or death, P=.025 (RR, 0.76 [95% CI, 0.59 to 0.97]). No serious adverse cardiac events were reported. The most common side effects were gastrointestinal. Conclusion--Hydroxychloroquine use in outpatients reduces the incidence of the composite outcome of COVID-19 infection, hospitalization, and death. Serious adverse events were not reported and cardiac arrhythmia was rare. Systematic review registration--This review was not registered.

scholarly journals Dental Composite Restorations Repair: A Systematic Review and Meta-analysis

2021 ◽  
pp. 707-738
Author(s):  
Abdulmohsen Al Rabiah ◽  
Alamri Zahrah ◽  
Tuwaym Malath ◽  
Al Daghri Ebtihal ◽  
Al Suhaibani Daniyah ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Prospective Cohort ◽  
Randomized Clinical Trials ◽  
Assessment Tool ◽  
Risk Of Bias ◽  
Dental Composite ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Bias Assessment

Background: Controversy exists in the literature regarding the most optimal repair procedure for improving the adhesion between the repair resin and the existing resin composite materials. Hence the aim of the present study was to do a systematic review and to analyze the adhesion potential of resin-based composites to similar and dissimilar composites and aimed to determine the possible dominant factors affecting the bond strength results. Materials & Methods: Randomized clinical trials (RCTs) and prospective cohort design were searched through electronic databases including MEDLINE, PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials for randomized clinical trials (RCTs) until July 2020 that compared different methods of composite restoration repair and a minimum mean follow-up time of 1 year. There were no restrictions on a particular treatment indication or outcome measures. Two authors independently conducted screening, risk of bias assessment, and data extraction of eligible trials in duplicate. We applied the Cochrane risk of bias assessment tool to consider the risk of bias. Results: We identified 10 articles; two of them were RCTs, and eight prospective cohort studies. There were 530 participants, with 990 teeth, dealing with resin-based composite (RBC) restorations. The intervention of defective restorations ranged from minimal intervention to total restoration replacement. The evaluation criteria were also varied with different evaluation protocols. The low number and heterogeneity of RCTs did not allow for meta-analyses. Conclusions: Although different repair protocols are mentioned in the literature according to the included studies, an appropriate and definitive conclusion can't be drawn. However, it seems repairs versus replacements should be considered as the first line of treatment when all factors lead to repair rather than replacement. Further randomized controlled trials with high methodological quality need to be conducted in order to establish evidence-based recommendations, particularly for RBC repair.

Acupuncture for Recurrent Headaches: A Systematic Review of Randomized Controlled Trials

Cephalalgia ◽  
1999 ◽  
Vol 19 (9) ◽  
pp. 779-786 ◽  
Author(s):  
D Melchart ◽  
K Linde ◽  
P Fischer ◽  
A White ◽  
G Allais ◽  
...  
Keyword(s):  
Systematic Review ◽  
Rate Ratio ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Real Life ◽  
Outcome Data ◽  
Responder Rate ◽  
Control Group ◽  
Controlled Trials

Objective: To assess whether there is evidence that acupuncture is effective in the treatment of recurrent headaches. Design: Systematic review. Study selection: Randomized or quasi-randomized clinical trials comparing acupuncture with any type of control intervention for the treatment of recurrent headaches. Data sources: Electronic databases (Medline, Embase, Cochrane Field for Complementary Medicine, Cochrane Controlled Trials Register), personal communications and bibliographies. Data collection and analysis: Information on patients, interventions, methods, and results were extracted by at least two independent reviewers using a pretested form. A pooled estimate of the responder rate ratio (responder rate in treatment group/responder rate in control group) was calculated as a crude indicator of trial results as meta-analysis of more specific outcome data was impossible due to heterogeneity and insufficient reporting. Results: Twenty-two trials, including a total of 1042 patients (median 36, range 10-150), met the inclusion criteria. Fifteen trials were in migraine patients, six in tension-headache patients, and in one trial patients with various headaches were included. The majority of the 14 trials comparing true and sham acupuncture showed at least a trend in favor of true acupuncture. The pooled responder rate ratio was 1.53 (95% confidence interval 1.11 to 2.11). The eight trials comparing acupuncture and other treatment forms had contradictory results. Conclusions: Overall, the existing evidence suggests that acupuncture has a role in the treatment of recurrent headaches. However, the quality and amount of evidence is not fully convincing. There is urgent need for well-planned, large-scale studies to assess effectiveness and efficiency of acupuncture under real life conditions.

scholarly journals Surgical Interventions for the Treatment of Supracondylar Humerus Fractures in Children: Protocol of a Systematic Review (Preprint)

2017 ◽  
Author(s):  
Oreste Lemos Carrazzone ◽  
João Carlos Belloti ◽  
Fabio Teruo Matsunaga ◽  
Nacime Salomão Barbachan Mansur ◽  
Marcelo Hide Matsumoto ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Surgical Treatment ◽  
Randomized Controlled Trials ◽  
Outcome Data ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Surgical Interventions ◽  
Randomized Controlled

BACKGROUND The treatment of supracondylar humerus fracture in children (SHFC) is associated with complications such as functional deficit, residual deformity, and iatrogenic neurological damage. The standard treatment is closed reduction and percutaneous Kirschner wire fixation with different configurations. Despite this fact, there is still no consensus on the most effective technique for the treatment of these fractures. OBJECTIVE The aim of this systematic review will be to evaluate the effect of surgical interventions on the treatment of Gartland type II and III SHFC by assessing function, complications, and error as primary outcomes. Clinical outcomes such as range of motion and pain and radiographic outcomes will also be judged. METHODS A systematic review of randomized controlled trials or quasi-randomized controlled trials evaluating the surgical treatment of SHFC will be carried out in the Cochrane Central Register of Controlled Trials, PubMed, Literatura Latino-Americana e do Caribe em Ciências da Saúde, and Excerpta Medica Database. The search will also occur at ongoing and recently completed clinical trials in selected databases. Data management and extraction will be performed using a data withdrawal form and by analyzing the following: study method characteristics, participant characteristics, intervention characteristics, results, methodological domains, and risk of bias. To assess the risk of bias of the included trials, the Cochrane Risk of Bias Tool will be used. Dichotomous outcome data will be analyzed as risk ratios, and continuous outcome data will be expressed as mean differences, both with 95% confidence intervals. Also, whenever possible, subgroup analysis, sensitivity analysis, and assessment of heterogeneity will be performed. RESULTS Following the publication of this protocol, searches will be run and included studies will be deeply analyzed. We hope to obtain final results in the next few months and have the final paper published by the end of 2018. This study was funded by a government-based noncommercial agency, Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP). CONCLUSIONS This study may provide surgical treatment effects evidence for SHFC. The results will assist clinical practice by demonstrating the effectiveness and potential complications of these interventions and might serve as a reference for future clinical trials on the topic. CLINICALTRIAL PROSPERO CRD42014009304; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=9304 (Archived by WebCite at http://www.webcitation.org/6usiDHzD7)

Effective Parental intervention strategies to reduce screen time among preschool-aged children: A systematic review (Preprint)

2020 ◽  
Author(s):  
Diana Raj ◽  
Halimatus Sakdiah Minhat ◽  
Nor Afiah Mohd. Zulkefli ◽  
Norliza Ahmad
Keyword(s):  
Systematic Review ◽  
Preschool Children ◽  
Young Children ◽  
Screen Time ◽  
Mode Of Delivery ◽  
Intervention Strategies ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Negative Consequences ◽  
Parental Intervention

BACKGROUND The increasing screen time exposure among young children in general and the reported negative consequences associated with excessive ST, calls for focused strategies to reduce ST, especially among young children. OBJECTIVE This systematic review aimed to identify effective parental intervention strategies to reduce ST among preschool children. METHODS A total of five databases, namely Cochrane Central Register of Controlled Trials, CINAHL, Medline Complete, PubMed, and Scopus, were searched for randomised controlled trials that involved intervention strategies in ST reduction among preschool children. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines were used. RESULTS A total of nine studies were assessed. The results showed that besides providing knowledge and awareness regarding ST, having restrictive practices, offering alternative activities to parents, and removal of screen from child’s bedroom were the most common strategies used by studies that reported successful intervention. Intervention duration of between six to eight weeks was sufficient to produce ST reduction. Face-to-face method was the commonest mode of delivery. Theoretical constructs that aimed at increasing parental self-efficacy, listing outcome expectations, and offering reinforcement of strategies that targeted both the parents and home environment were beneficial in reducing ST. CONCLUSIONS By offering appropriate strategies to parents, a reduction in the amount of ST was observed among the children. Future intervention studies could benefit in exploring culturally adapted strategies, especially in developing countries. Trials of higher quality would also facilitate the drawing of conclusions in future research. CLINICALTRIAL PROSPERO No: CRD42020199398

scholarly journals Effect of gut microbiota modulation on feeding tolerance of enterally fed critically ill adult patients: a systematic review

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Najmeh Seifi ◽  
Ali Jafarzadeh Esfahani ◽  
Alireza Sedaghat ◽  
Reza Rezvani ◽  
Majid Khadem-Rezaiyan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Gut Microbiota ◽  
Beneficial Effect ◽  
Critically Ill ◽  
Energy Intake ◽  
Adult Patients ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Clinical Endpoints ◽  
Feeding Tolerance

Abstract Purpose The objective of this systematic review was to evaluate the effect of pre-, pro-, and synbiotics on feeding tolerance of enterally fed critically ill adult patients. Methods MEDLINE, Science Direct, Web of Knowledge, and the Cochrane Central Register of Controlled Trials were searched up to November 2019. English language randomized controlled trials reporting the effect of pre, pro or synbiotics on the feeding tolerance of enterally fed critically ill adult patients were included. Results Overall, 15 papers were selected for review. Among six studies reporting the energy intake, only two studies showed significantly higher energy intake in the prebiotic-receiving groups. Among four RCTs reporting frequency or time to achieve the target calorie, only one found a significant effect of probiotics to reduce the time to achieve a target dose of calorie. About the prevalence or duration of diarrhea, 7 out of 12 RCTs reported a beneficial effect. All but one study found no beneficial effects for gut microbiota manipulation on clinical endpoints including length of stay (LOS) in hospital and intensive care unit (ICU). Conclusion It should be noticed that the heterogeneity in study designs, product format, and ICU patient populations makes it difficult to draw any general conclusion. Overall, it seems that pre, pro, or synbiotics have no significant beneficial effect on feeding tolerance and clinical endpoints in critically ill adults, but they may reduce the prevalence or duration of diarrhea.

scholarly journals Efficacy and safety of inulin supplementation for functional constipation: a systematic review protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e042597
Author(s):  
Xinyuan Liu ◽  
Qing Yang ◽  
Zhongning He ◽  
Shukun Yao
Keyword(s):  
Systematic Review ◽  
Lifestyle Intervention ◽  
Functional Constipation ◽  
Biomedical Literature ◽  
Basic Material ◽  
Economic Losses ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Clinical Trial Registry

IntroductionFunctional constipation (FC) is a common digestive system disease, with an uptrend in morbidity and mortality, resulting in huge social and economic losses. Although the guidelines recommend lifestyle intervention as a first-line treatment, lifestyle intervention is not widely used in clinic. Inulin can be used as the basic material of functional food. Clinical studies have shown that inulin supplementation is associated with increased frequency of bowel movements, but has certain side effects. Therefore, the efficacy and safety of inulin in the treatment of FC need to be further evaluated.Methods and analysisWe will search Medline, Web of Science, Embase, China National Knowledge Infrastructure Database, Wanfang Database and China Biomedical Literature Database. We will also search the China Clinical Trial Registry, the Cochrane Central Register of Controlled Trials and related conference summaries. This systematic review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RevMan V.5.3.5 will be used for analysis.Ethics and disseminationThis systematic review will evaluate the efficacy and safety of inulin supplementation for the treatment of FC. All included data will be obtained from published articles, there is no need for the ethical approval, and it will be published in a peer-reviewed journal. Due to lack of a new systematic review in this field, this study will combine relevant randomised controlled trials to better explore the evidence of inulin supplementation in the treatment of FC and guide clinical practice and clinical research.PROSPERO registration numberCRD42020189234.

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