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Ideal vs. real: a systematic review on handling covariates in randomized controlled trials.

ABSTRACT: BACKGROUND:In theory, efficient design of randomized controlled trials (RCTs) involves randomization algorithms that control baseline variable imbalance efficiently, and corresponding analysis involves pre-specified adjustment for baseline covariates. This review sought to explore techniques for handling potentially influential baseline variables in both the design and analysis phase of RCTs. METHODS:We searched PubMed for articles indexed "randomized controlled trial", published in the NEJM, JAMA, BMJ, or Lancet for two time periods: 2009 and 2014 (before and after updated CONSORT guidelines). Upon screening (343), 298 articles underwent full review and data abstraction. RESULTS:Typical articles reported on superiority (86%), multicenter (92%), two-armed (79%) trials; 81% of trials involved covariates in the allocation and 84% presented adjusted analysis results. The majority reported a stratified block method (69%) of allocation, and of the trials reporting adjusted analyses, 91% were pre-specified. Trials published in 2014 were more likely to report adjusted analyses (87% vs. 79%, p?=?0.0100) and more likely to pre-specify adjustment in analyses (95% vs. 85%, p?=?0.0045). Studies initiated in later years (2010 or later) were less likely to use an adaptive method of randomization (p?=?0.0066; 7% of those beginning in 2010 or later vs. 31% of those starting before 2000) but more likely to report a pre-specified adjusted analysis (p?=?0.0029; 97% for those initiated in 2010 or later vs. 69% of those started before 2000). CONCLUSION:While optimal reporting procedures and pre-specification of adjusted analyses for RCTs tend to be progressively more prevalent over time, we see the opposite effect on reported use of covariate-adaptive randomization methods.

SUBMITTER: Ciolino JD

PROVIDER: S-EPMC6610785 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Ideal vs. real: a systematic review on handling covariates in randomized controlled trials.

Ciolino Jody D JD Palac Hannah L HL Yang Amy A Vaca Mireya M Belli Hayley M HM

BMC medical research methodology 20190703 1

<h4>Background</h4>In theory, efficient design of randomized controlled trials (RCTs) involves randomization algorithms that control baseline variable imbalance efficiently, and corresponding analysis involves pre-specified adjustment for baseline covariates. This review sought to explore techniques for handling potentially influential baseline variables in both the design and analysis phase of RCTs.<h4>Methods</h4>We searched PubMed for articles indexed "randomized controlled trial", published ...[more]

PMID: 31269898

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Project description:Objective: The optimal management for cervical artery dissection (CAD) is uncertain. This study aimed to summarize the current randomized controlled trials (RCTs) to compare the efficacy and safety of antiplatelet and anticoagulation therapies for CAD. Methods: A literature search was conducted in the major databases, such as MEDLINE, Embase, and the Cochrane Library. Only the RCTs comparing the antiplatelet and anticoagulation therapies for the patients with CAD were included. Combined estimates of the relative risk (RR) of antiplatelet vs. anticoagulation were analyzed. Heterogeneity was measured using the I 2 statistical analysis. The analyses were performed in the intention-to-treat (ITT) and per-protocol (PP) population, respectively. Results: Two RCTs involving 444 patients in the ITT population and 370 patients in the PP population were included. The quality of studies was high overall. In the ITT population, compared with the patients in the anticoagulation group, the patients in the antiplatelet group showed a higher rate of ischemic stroke within 3 months (RR = 6.73 [95% CI, 1.22-37.15], I 2 = 0%, P = 0.029). No difference between these two treatment groups was found for the outcomes of transient ischemic attack (RR = 0.37 [95% CI, 0.09-1.58], I 2 = 0%, P = 0.181), intracranial hemorrhage (RR = 0.33 [95% CI, 0.01-7.98], I 2 = 0%, P = 0.494), major extracranial bleeding (RR = 0.31 [95% CI, 0.01-7.60], I 2 = 0%, P = 0.476), or the composite of these outcomes within 3 months. For the PP population, the results of the meta-analysis of outcomes between the antiplatelet and anticoagulation groups were consistent with the ITT population. Conclusions: Compared with the antiplatelet group, the anticoagulation group has a lower risk of ischemic stroke without increasing bleeding risk when treating CAD. Anticoagulation seems to be superior over the antiplatelet in treating CAD but needs to be further tested by specifying several issues, such as location, initial symptom types, and treatment protocols.

Project description:BackgroundThis systematic review evaluated the effectiveness of process interventions (education for clinicians, parent presence, education of parents [before and on day of vaccination], and education of patients on day of vaccination) on reducing vaccination pain, fear, and distress and increasing the use of interventions during vaccination.Design/methodsDatabases were searched using a broad search strategy to identify relevant randomized and quasi-randomized controlled trials. Critical outcomes were pain, fear, distress (when applicable), and use of pain management interventions. Data were extracted according to procedure phase (preprocedure, acute, recovery, combinations of these) and pooled using established methods. Analyses were conducted using standardized mean differences (SMD) and risk ratios (RR).ResultsThirteen studies were included. Results were generally mixed. On the basis of low to very low-quality evidence, the following specific critical outcomes showed significant effects suggesting: (1) clinicians should be educated about vaccine injection pain management (use of interventions: SMD 0.66; 95% confidence interval [CI]: 0.47, 0.85); (2) parents should be present (distress preprocedure: SMD -0.85; 95% CI: -1.35, -0.35); (3) parents should be educated before the vaccination day (use of intervention preprocedure: SMD 0.83; 95% CI: 0.25, 1.41 and RR, 2.08; 95% CI: 1.51, 2.86; distress acute: SMD, -0.35; 95% CI: -0.57, -0.13); (4) parents should be educated on the vaccination day (use of interventions: SMD 1.02; 95% CI: 0.22, 1.83 and RR, 2.42; 95% CI: 1.47, 3.99; distress preprocedure+acute+recovery: SMD -0.48; 95% CI: -0.82, -0.15); and (5) individuals 3 years of age and above should be educated on the day of vaccination (fear preprocedure: SMD -0.67; 95% CI: -1.28, -0.07).ConclusionsEducating individuals involved in the vaccination procedure (clinicians, parents of children being vaccinated; individuals above 3 y of age) is beneficial to increase use of pain management strategies, reduce distress surrounding with vaccination, and to reduce fear. When possible, parent presence is also recommended for children undergoing vaccination.

Project description:BackgroundTelemedicine modalities, such as videoconferencing, are used by health care providers to remotely deliver health care to patients. Telemedicine use in pediatrics has increased in recent years. This has resulted in improved health care access, optimized disease management, progress in the monitoring of health conditions, and fewer exposures to patients with illnesses during pandemics (eg, the COVID-19 pandemic).ObjectiveWe aimed to systematically evaluate the most recent evidence on the feasibility and accessibility of telemedicine services, patients' and care providers' satisfaction with these services, and treatment outcomes related to telemedicine service use among pediatric populations with different health conditions.MethodsStudies were obtained from the PubMed database on May 10, 2020. We followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. In this review, we included randomized controlled trials from the last 10 years that used a telemedicine approach as a study intervention or assessed telemedicine as a subspecialty of pediatric care. Titles and abstracts were independently screened based on the eligibility criteria. Afterward, full texts were retrieved and independently screened based on the eligibility criteria. A standardized form was used to extract the following data: publication title, first author's name, publication year, participants' characteristics, study design, the technology-based approach that was used, intervention characteristics, study goals, and study findings.ResultsIn total, 11 articles met the inclusion criteria and were included in this review. All studies were categorized as randomized controlled trials (8/11, 73%) or cluster randomized trials (3/11, 27%). The number of participants in each study ranged from 22 to 400. The health conditions that were assessed included obesity (3/11, 27%), asthma (2/11, 18%), mental health conditions (1/11, 9%), otitis media (1/11, 9%), skin conditions (1/11, 9%), type 1 diabetes (1/11, 9%), attention deficit hyperactivity disorder (1/11, 9%), and cystic fibrosis-related pancreatic insufficiency (1/11). The telemedicine approaches that were used included patient and doctor videoconferencing visits (5/11, 45%), smartphone-based interventions (3/11, 27%), telephone counseling (2/11, 18%), and telemedicine-based screening visits (1/11, 9%). The telemedicine interventions in all included studies resulted in outcomes that were comparable to or better than the outcomes of control groups. These outcomes were related to symptom management, quality of life, satisfaction, medication adherence, visit completion rates, and disease progression.ConclusionsAlthough more research is needed, the evidence from this review suggests that telemedicine services for the general public and pediatric care are comparable to or better than in-person services. Patients, health care professionals, and caregivers may benefit from using both telemedicine services and traditional, in-person health care services. To maximize the potential of telemedicine, future research should focus on improving patients' access to care, increasing the cost-effectiveness of telemedicine services, and eliminating barriers to telemedicine use.

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Ideal vs. real: a systematic review on handling covariates in randomized controlled trials.

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Ideal vs. real: a systematic review on handling covariates in randomized controlled trials.

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