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Superiority Claims for Spinal Devices: A Systematic Review of Randomized Controlled Trials.

ABSTRACT: Study Design:Systematic review. Objectives:Superiority claims for medical devices are commonly derived from noninferiority trials, but interpretation of such claims can be challenging. This study aimed to (a) establish the prevalence of noninferiority and superiority designs among spinal device trials, (b) assess the frequency of post hoc superiority claims from noninferiority studies, and (c) critically evaluate the risk of bias in claims that could translate to misleading conclusions. Methods:Study bias was assessed using the Cochrane Risk of Bias Tool. The risk of bias for the superiority claim was established based on post hoc hypothesis specification, analysis of the intention-to-treat population, post hoc modification of a priori primary outcomes, and sensitivity analyses. Results:Forty-one studies were identified from 1895 records. Nineteen (46%) were noninferiority trials. Fifteen more (37%) were noninferiority trials with a secondary superiority hypothesis specified a priori. Seven (17%) were superiority trials. Of the 34 noninferiority trials, 14 (41%) made superiority claims. A medium or high risk of bias was related to the superiority claim in 9 of those trials (64%), which was due to the analyzed population, lacking sensitivity analyses, claims not being robust during sensitivity analyses, post hoc hypotheses, or modified endpoints. Only 4 of the 14 (29%) noninferiority studies provided low bias in the superiority claim, compared with 3 of the 5 (60%) superiority trials. Conclusions:Health care decision makers should carefully evaluate the risk of bias in each superiority claim and weigh their conclusions appropriately.

SUBMITTER: Golish SR

PROVIDER: S-EPMC7160807 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Superiority Claims for Spinal Devices: A Systematic Review of Randomized Controlled Trials.

Golish S Raymond SR Groff Michael W MW Araghi Ali A Inzana Jason A JA

Global spine journal 20190607 3

<h4>Study design</h4>Systematic review.<h4>Objectives</h4>Superiority claims for medical devices are commonly derived from noninferiority trials, but interpretation of such claims can be challenging. This study aimed to (<i>a</i>) establish the prevalence of noninferiority and superiority designs among spinal device trials, (<i>b</i>) assess the frequency of post hoc superiority claims from noninferiority studies, and (<i>c</i>) critically evaluate the risk of bias in claims that could translate ...[more]

PMID: 32313799

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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.

Project description:In 2012, the United States Food and Drug Administration (FDA) issued a warning regarding potential adverse effects of HMG-CoA reductase inhibitors (statins) on cognition, based on the Adverse Events Reporting System and a review of the medical literature. We aimed to synthesize randomized clinical trial (RCTs) evidence on the association between statin therapy and cognitive outcomes.We searched MEDLINE, EMBASE, and Cochrane CENTRAL through December 2012, and reviewed published systematic reviews of statin treatment. We sought RCTs that compared statin treatment versus placebo or standard care, and reported at least one cognitive outcome (frequency of adverse cognitive events or measurements using standard neuropsychological cognitive test scores). Studies reporting sufficient information to calculate effect sizes were included in meta-analyses. Standardized and unstandardized mean differences were calculated for continuous outcomes for global cognition and for pre-specified cognitive domains. The main outcome was change in cognition measured by neuropsychological tests; an outcome of secondary interest was the frequency of adverse cognitive events observed during follow-up.We identified 25 RCTs (all placebo-controlled) reporting cognitive outcomes in 46,836 subjects, of which 23 RCTs reported cognitive test results in 29,012 participants. Adverse cognitive outcomes attributable to statins were rarely reported in trials involving cognitively normal or impaired subjects. Furthermore, meta-analysis of cognitive test data (14 studies; 27,643 participants) failed to show significant adverse effects of statins on all tests of cognition in either cognitively normal subjects (standardized mean difference 0.01, 95% confidence interval, CI, -0.01 to 0.03, p?=?0.42) or Alzheimer's disease subjects (standardized mean difference -0.05, 95% CI -0.19 to 0.10, p?=?0.38).Statin therapy was not associated with cognitive impairment in RCTs. These results raise questions regarding the continued merit of the FDA warning about potential adverse effects of statins on cognition.

Project description:BackgroundArtificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have shown potential for a range of clinical tasks such as diagnostics, prognostics, and therapeutic decision-making such as drug dosing. There is, however, an urgent need to ensure that these technologies remain safe for all populations. Recent literature demonstrates the need for rigorous performance error analysis to identify issues such as algorithmic encoding of spurious correlations (eg, protected characteristics) or specific failure modes that may lead to patient harm. Guidelines for reporting on studies that evaluate AI medical devices require the mention of performance error analysis; however, there is still a lack of understanding around how performance errors should be analyzed in clinical studies, and what harms authors should aim to detect and report.ObjectiveThis systematic review will assess the frequency and severity of AI errors and adverse events (AEs) in randomized controlled trials (RCTs) investigating AI medical devices as interventions in clinical settings. The review will also explore how performance errors are analyzed including whether the analysis includes the investigation of subgroup-level outcomes.MethodsThis systematic review will identify and select RCTs assessing AI medical devices. Search strategies will be deployed in MEDLINE (Ovid), Embase (Ovid), Cochrane CENTRAL, and clinical trial registries to identify relevant papers. RCTs identified in bibliographic databases will be cross-referenced with clinical trial registries. The primary outcomes of interest are the frequency and severity of AI errors, patient harms, and reported AEs. Quality assessment of RCTs will be based on version 2 of the Cochrane risk-of-bias tool (RoB2). Data analysis will include a comparison of error rates and patient harms between study arms, and a meta-analysis of the rates of patient harm in control versus intervention arms will be conducted if appropriate.ResultsThe project was registered on PROSPERO in February 2023. Preliminary searches have been completed and the search strategy has been designed in consultation with an information specialist and methodologist. Title and abstract screening started in September 2023. Full-text screening is ongoing and data collection and analysis began in April 2024.ConclusionsEvaluations of AI medical devices have shown promising results; however, reporting of studies has been variable. Detection, analysis, and reporting of performance errors and patient harms is vital to robustly assess the safety of AI medical devices in RCTs. Scoping searches have illustrated that the reporting of harms is variable, often with no mention of AEs. The findings of this systematic review will identify the frequency and severity of AI performance errors and patient harms and generate insights into how errors should be analyzed to account for both overall and subgroup performance.Trial registrationPROSPERO CRD42023387747; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=387747.International registered report identifier (irrid)PRR1-10.2196/51614.

Dataset Information

Superiority Claims for Spinal Devices: A Systematic Review of Randomized Controlled Trials.

Publications

Superiority Claims for Spinal Devices: A Systematic Review of Randomized Controlled Trials.

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