Randomized Controlled Trials Of Interventions Research Articles

Supporting smoking cessation and preventing relapse following a stay in a smoke-free setting: a meta-analysis and investigation of effective behaviour change techniques.

Admission to a smoke-free setting presents a unique opportunity to encourage smokers to quit. However, risk of relapse post-discharge is high, and little is known about effective strategies to support smoking cessation following discharge. We aimed to identify interventions that maintain abstinence following a smoke-free stay and determine their effectiveness, as well as the probable effectiveness of behaviour change techniques (BCTs) used in these interventions. Systematic review and meta-analyses of studies of adult smokers aged ≥18years who were temporarily or fully abstinent from smoking to comply with institutional smoke-free policies. Institutions included prison, inpatient mental health, substance misuse or acute hospital settings. A Mantel-Haenszel random-effects meta-analysis of randomized controlled trials (RCTs) was conducted using biochemically verified abstinence (7-day point prevalence or continuous abstinence). BCTs were defined as 'promising' in terms of probable effectiveness (if BCT was present in two or more long-term effective interventions) and feasibility (if BCT was also delivered in ≥25% of all interventions). Thirty-seven studies (intervention n=9041, control n=6195) were included: 23 RCTs (intervention n=6593, control n=5801); three non-randomized trials (intervention n=845, control n=394) and 11 cohort studies (n=1603). Meta-analysis of biochemically verified abstinence at longest follow-up (4weeks-18months) found an overall effect in favour of intervention [risk ratio (RR)=1.27, 95% confidence interval (CI)=1.08-1.49, I2 =42%]. Nine BCTs (including 'pharmacological support', 'goal-setting (behaviour)' and 'social support') were characterized as 'promising' in terms of probable effectiveness and feasibility. A systematic review and meta-analyses indicate that behavioural and pharmacological support is effective in maintaining smoking abstinence following a stay in a smoke-free institution. Several behaviour change techniques may help to maintain smoking abstinence up to 18months post-discharge.

Teaching Back Health in the School Setting: A Systematic Review of Randomized Controlled Trials.

School-based interventions have reported effectiveness on back health; however, there are no specific guidelines for teaching body mechanics and posture in primary and secondary schools. To identify, describe, and analyze the educative features of randomized controlled trials (RCTs) on back health developed to date in the school setting, a systematic review was performed following the preferred reporting items for systematic reviews and meta-analyses (PRISMA) recommendations. RCTs exclusively focused on educational setting electronic databases included PubMed, EMBASE, PEDro, Web of Science, SPORTDiscus, ERIC, and MEDLINE on the Ovid platform. Databases were searched for potentially eligible studies from the earliest date up to 18th March 2020. A total of 584 records were obtained from the database searches. A total of six articles that applied inclusion criteria were assessed for eligibility. All of these studies found improvements in postural habits and the level of knowledge with regard to back health, as well as a reduction in the prevalence of back pain. None of the studies used the student-centered method, and three studies used evaluation instruments with a pilot validation. Research on RCT interventions concerning back health in the school setting is scarce. None of the interventions applied a constructivist or student-centered method. The use of validated and standardized assessment instruments is required.

Interventions to prevent anastomotic leak after esophageal surgery: a systematic review and meta-analysis

BackgroundAnastomotic leakage (AL) is a common and serious complication following esophagectomy. We aimed to provide an up-to-date review and critical appraisal of the efficacy and safety of all previous interventions aiming to reduce AL risk.MethodsWe searched MEDLINE and Embase from 1946 to January 2019 for randomized controlled trials (RCTs) evaluating interventions to minimize esophagogastric AL. Pooled risk ratios (RR) for AL were obtained using a random effects model.ResultsTwo reviewers screened 441 abstracts and identified 17 RCTs eligible for inclusion; 11 studies were meta-analyzed. Omentoplasty significantly reduced the risk of AL by 78% [RR: 0.22; 95% CI: 0.10, 0.50] compared to conventional anastomosis (3 studies, n = 611 patients). Early removal of NG tube significantly reduced the risk of AL by 62% [RR: 0.38; 95% CI: 0.02, 0.65] compared to prolonged NG tube removal (2 studies, n = 293 patients); Stapled anastomosis did not significantly reduce the risk of AL [RR: 0.92; 95% CI: 0.45, 1.87] compared to hand-sewn anastomosis (6 studies, n = 1454 patients). The quality of evidence was high for omentoplasty (vs. conventional anastomosis), moderate for early NG tube removal (vs. prolonged NG tube removal), and very low for stapled anastomosis (vs. hand-sewn anastomosis).ConclusionsThis is the first meta-analysis to summarize the graded quality of evidence for all RCT interventions designed to reduce the risk of AL following esophagectomy. Our findings demonstrated that omentoplasty significantly reduced the risk of AL with a high quality of evidence. Although early NG tube removal significantly reduced AL risk, there is a need for further research to strengthen the quality of evidence for this finding. Evidence profiles presented in our review may help inform the development of future clinical practice recommendations.Systematic review registration: CRD42019127181.

Examining Organizational Factors Supporting the Adoption and Use of Evidence-Based Interventions.

The purpose of this study was to develop a greater understanding of the factors influencing the adoption of evidence-based interventions in outpatient mental health clinics serving youth. An improved understanding of these factors can potentially improve efforts to ensure effective adoption, implementation, and sustainment of evidence-based interventions, and thus improve treatment for youth in mental health settings. This explanatory cross-sectional study involves secondary data analysis of a longitudinal randomized control intervention trial. The SEM- based model that was tested supported the primary hypothesis that a more supportive organizational climate with greater readiness for change is more likely to improve the chances for the adoption of evidence-based interventions in outpatient mental health clinics serving youths.

Effectiveness of preventive interventions and Randomised Controlled Trials in Occupational Health: an overview of the last five decades.

Introduction: Evidence-Based Medicine, as a new scientific paradigm, modified the approach to diagnosis, treatment and prevention of diseases based on the best available scientific evidence synthesized in systematic reviews since the last decade of the past century. To evaluate its influence, we assessed the trend in the number and proportion of randomised controlled trials (RCTs) and systematic reviews of preventive interventions in occupational health (OH) over the last five decades. Methods: PubMed has been searched using established search filters regarding occupational determinants of diseases, OH preventive interventions, RCTs and systematic reviews. The number of hits were assessed per decade. We estimated the number of pertinent studies in the systematically recruited samples of retrieved citations. Results: Over the years, the number of studies concerning the effectiveness of preventive interventions in OH increased 3.5-fold from 986 in 1970-1979 to 3,428 in 2010-2019. RCTs of preventive interventions increased more than 60-fold from 6 in the seventies to 370 in the last decade. Systematic reviews first appeared at the end of the past century with a 30-fold increase (from 4 to 120) over the last three decades. Discussion: The number of high-quality studies, such as RCTs and systematic reviews evaluating the effectiveness of preventive interventions in OH, has increased more rapidly than other studies on this topic. The Evidence-Based Medicine philosophy, diffused by researchers worldwide, has promoted the evaluation of the effectiveness of preventive interventions in OH.

A Protocol of Process Evaluations of Interventions for the Prevention of Type 2 Diabetes in Women With Gestational Diabetes Mellitus: A Systematic Review

Background Process evaluations of randomised controlled trials (RCTs) can provide insight and inform us on the intervention implementation, the causal mechanisms and the contextual factors. This will inform about interventions’ success or failure due to their implementation or the interventions themselves. We aim to consolidate the methodology from previous process evaluations of complex interventions upon their findings on facilitators and barriers to address the prevention of type 2 diabetes mellitus among women with gestational diabetes mellitus (GDM). Methods Comprehensive search will be conducted on electronic databases and reference lists of recent reviews for RCTs of complex interventions which address process evaluations of diabetes prevention intervention (DPI) for women with GDM in healthcare settings. There is no restriction on the language of the papers and year of publication until December 2020. Data from each study will be extracted by two reviewers independently using standardised forms. Data extracted include descriptive items on the study design and the outcomes of process evaluations from the three dimensions: (1) implementation; (2) mechanism of impact and (3) context. The quality of the studies will be assessed using mixed methods appraisal tool which is designed for the appraisal of mixed studies in systematic reviews. A narrative and framework analysis of the findings will be presented to inform the contents of a new DPI for women with GDM. Discussion The findings from this process evaluation findings are valuable in determining whether a complex intervention should be scaled up or modified for other contexts in future plan. It will give deeper understanding of potential challenges and solutions to aid in the implementation of effective DPIs for GDM in Malaysia.

Antenatal interventions for preventing stillbirth, fetal loss and perinatal death: an overview of Cochrane systematic reviews.

Antenatal interventions for preventing stillbirth, fetal loss and perinatal death: an overview of Cochrane systematic reviews.

Experience of Elderly People Regarding the Effect of Yoga/Light Exercise on Sedentary Behavior: A Longitudinal Qualitative Study in Madhya Pradesh, India.

This study is set on the background of a randomized control trial (RCT) in which intervention was carried to observe the effects of yoga/light exercise on the improvement in health and well-being among the elderly population. A longitudinal qualitative study was conducted as part of RCT interventions to explore the experience of the elderly practicing yoga/light exercise in relation to sedentary behavior in the Ujjain district of Madhya Pradesh, India. Participants of the RCT were selected for this study. Eighteen focus group discussions were conducted—six during each phase of RCT interventions (before, during, and after). The findings regarding motivating and demotivating factors in various phases of intervention were presented in three categories: experience and perception of the effects of yoga/light exercise on sedentary behavior (1) before, (2) during, and (3) after intervention. This study explores the positive effect of yoga/light exercise on sedentary behavior and subjective well-being on the elderly population. They were recognized to have undergone changes in their physical and emotional well-being by consistently practicing yoga/light exercise. The main driving factors were periodic health check-ups and the encouragement of qualified trainers without any cost. This study concludes with the notion that these interventions should be encouraged in the community to use physical exercise as a method to better control the physical and social effects of aging.

Systematic Review of Primary Outcome Measurements for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) in Randomized Controlled Trials.

Background: Due to its unknown etiology, the objective diagnosis and therapeutics of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) are still challenging. Generally, the patient-reported outcome (PRO) is the major strategy driving treatment response because the patient is the most important judge of whether changes are meaningful. Methods: In order to determine the overall characteristics of the main outcome measurement applied in clinical trials for CFS/ME, we systematically surveyed the literature using two electronic databases, PubMed and the Cochrane Library, throughout June 2020. We analyzed randomized controlled trials (RCTs) for CFS/ME focusing especially on main measurements. Results: Fifty-two RCTs out of a total 540 searched were selected according to eligibility criteria. Thirty-one RCTs (59.6%) used single primary outcome and others adapted ≥2 kinds of measurements. In total, 15 PRO-derived tools were adapted (50 RCTs; 96.2%) along with two behavioral measurements for adolescents (4 RCTs; 7.7%). The 36-item Short Form Health Survey (SF-36; 16 RCTs), Checklist Individual Strength (CIS; 14 RCTs), and Chalder Fatigue Questionnaire (CFQ; 11 RCTs) were most frequently used as the main outcomes. Since the first RCT in 1996, Clinical Global Impression (CGI) and SF-36 have been dominantly used each in the first and following decade (26.1% and 28.6%, respectively), while both CIS and Multidimensional Fatigue Inventory (MFI) have been the preferred instruments (21.4% each) in recent years (2016 to 2020). Conclusions: This review comprehensively provides the choice pattern of the assessment tools for interventions in RCTs for CFS/ME. Our data would be helpful practically in the design of clinical studies for CFS/ME-related therapeutic development.

The impact of adult behavioural weight management interventions on mental health: A systematic review and meta-analysis.

There is good evidence that behavioural weight management interventions improve physical health; however, the impact on mental health remains unclear. We evaluated the impact of behavioural weight management interventions on mental health-related outcomes in adults with overweight or obesity at intervention-end and 12 months from baseline. Eligible studies were randomized controlled trials (RCTs) or cluster RCTs of adult behavioural weight loss interventions reporting affect, anxiety, binge eating, body image, depression, emotional eating, quality of life, self-esteem and stress. We searched seven databases from inception to 7 May 2019 and included 43 articles reporting 42 RCTs. Eighteen studies were deemed to be at high risk of bias. We conducted random-effects meta-analyses, stratified analyses and meta-regression using Stata. Interventions generated greater improvements than comparators for depression, mental health-related quality of life and self-efficacy at intervention-end and 12 months from baseline. There was no difference between groups for anxiety, overall quality of life, self-esteem or stress at intervention-end. There was insufficient evidence to assess the impact on anxiety, binge eating, body image, emotional eating, affect, life satisfaction, self-esteem or stress at intervention-end and/or 12 months from baseline. Although evidence suggests that interventions benefit some aspects of mental health, high-quality, transparently reported RCTs measuring a range of mental health outcomes over longer durations are required to strengthen the evidence base.

A systematic review and meta-analysis of effects of psychosocial interventions on spiritual well-being in adults with cancer.

Spiritual well-being (SpWb) is an important dimension of health-related quality of life for many cancer patients. Accordingly, an increasing number of psychosocial intervention studies have included SpWb as a study endpoint, and may improve SpWb even if not designed explicitly to do so. This meta-analysis of randomized controlled trials (RCTs) evaluated effects of psychosocial interventions on SpWb in adults with cancer and tested potential moderators of intervention effects. Six literature databases were systematically searched to identify RCTs of psychosocial interventions in which SpWb was an outcome. Doctoral-level rater pairs extracted data using Covidence following Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. Standard meta-analytic techniques were applied, including meta-regression with robust variance estimation and risk-of-bias sensitivity analysis. Forty-one RCTs were identified, encompassing 88 treatment effects among 3883 survivors. Interventions were associated with significant improvements in SpWb (g = 0.22, 95% CI [0.14, 0.29], p < 0.0001). Studies assessing the FACIT-Sp demonstrated larger effect sizes than did those using other measures of SpWb (g = 0.25, 95% CI [0.17, 0.34], vs. g = 0.10, 95% CI [-0.02, 0.23], p = 0.03]. No other intervention, clinical, or demographic characteristics significantly moderated effect size. Psychosocial interventions are associated with small-to-medium-sized effects on SpWb among cancer survivors. Future research should focus on conceptually coherent interventions explicitly targeting SpWb and evaluate interventions in samples that are diverse with respect to race and ethnicity, sex and cancer type.

Facilitating smoking cessation using reduced nicotine cigarettes: Intervention development and RCT study design

Smoking cigarettes with substantially lower nicotine than conventional cigarettes prior to a quit attempt may reduce the reinforcing effects of smoking, which could facilitate smoking cessation through extinction learning. This paper describes the development of a smoking cessation intervention designed to optimize extinction processes using reduced nicotine cigarettes, as well as the design and methods for an ongoing randomized controlled trial (RCT) to evaluate this intervention. Qualitative methods and pilot testing were conducted to develop the novel facilitated extinction (FE) intervention, with a key focus on maximizing opportunities for extinction learning during a five-week pre-quit period. The primary aims of the RCT are to test the effects of the FE intervention versus a standard (cognitive-behavioral) intervention, while also comparing two nicotine reduction schedules for providing very low nicotine content (VLNC) cigarettes. The efficacy of the intervention is currently being evaluated with treatment-seeking smokers (n = 208) randomly assigned to one of four conditions crossing FE versus standard intervention with immediate versus gradual transition to VLNC cigarettes.

Universal childhood obesity prevention in a rural community: Study design, methods and baseline participant characteristics of the NU-HOME randomized controlled trial

Childhood obesity is a major health concern in the United States (US) and those living in rural communities are at higher risk than their urban counterparts. Few prevention trials have engaged whole families of school-age children in community settings, and none to date have promoted family meals, family activity and healthful home environments in rural settings through a rigorous, randomized controlled trial (RCT). The New Ulm at HOME (NU-HOME) study recruited 114 parent/child dyads in a two-arm (intervention versus wait-list control) RCT to test the efficacy of a family meals-focused program aimed to prevent excess weight gain among 7–10 year-old children in rural Minnesota. The NU-HOME program was adapted from a previously tested program for urban families through a unique community collaboration. The program included 7 monthly in-person sessions for all family members. Parents also participated in 4 motivational goal-setting phone calls. The primary outcome measures were age- and sex-adjusted child body mass index (BMI) z-score, percent body fat, and incidence of overweight and obesity post-intervention. Secondary outcomes included quality of food and beverage availability in the home; family meals and snacks; children's dietary intake quality (e.g., Healthy Eating Index (HEI)-2015, fruits and vegetables, sugar-sweetened beverages, snacks); and children's screen time and weekly minutes of moderate-to-vigorous physical activity, total physical activity, and sedentary behavior. The NU-HOME RCT was a collaborative effort of academic and health system researchers, interventionists and community leaders that aimed to prevent childhood obesity in rural communities through engagement of the whole family in an interactive intervention.

Randomized controlled trials in non-pharmacological rehabilitation research: a scoping review of the reporting of sample size calculation, randomization procedure, and statistical analyses.

The randomized controlled trials (RCTs) are often considered as the gold standard for clinical trials and researchers argue that the quality of RCT reports should be of the highest standards due to their clinical significance. To review the quality of reporting of the sample size calculation methods, and randomization procedures, and assess whether the statistical analyses correlate as reported in the trials' Evidence acquisition and Evidence synthesis sections in non-pharmacological, physiological rehabilitation RCT interventions. A systematic electronic search was conducted in Cochrane Central from 1 January 2019 to 16 December 2019. Titles and abstracts were analyzed for inclusion independently by two authors, and disagreements were resolved by a third reader. Studies were included if they met the following criteria: 1) assessed and reported a type of non-pharmacological rehabilitation RCT (e.g. physiotherapy); 2) randomized intervention to patients with a disease comparing to healthy or patients without intervention as the comparison group; 3) published in an indexed journal; and 4) original research, available full text, human study, published in 2019, and written in English. The following information was extracted from the included articles: journal impact factor (JIF), sample size calculation methods (SS), randomization procedure (RND), and statistical analyses (STAT) reported. Analyzing the full text, whether SS and RND were reported or not and whether the STAT correlated with the Methods and Results sections. The prevalence of each statistical method was derived from the Methods section of the report and compared if it was reported in the Results section. The continuous variable of JIF was tested for normality and used for independent t-test for equality of means between categories. In addition, using Downs and Black checklist the methodological quality of the articles was assessed and categorized to be poor, fair, good, and excellent based on the checklist's score. Finally, the association between the assessed quality (categorical variable) of the articles and the reporting variables (categorical variables) was analyzed utilizing the Pearson χ2. One hundred and nighty-four articles were retrieved from the systematic search out of which 99 (51%) were included for data extraction and further analyses. About one in five (20.2%) and two in five (37.4%) did not properly and adequately report the SS and RND while one in five (19.2%) there was at least one mismatch in STAT. The JIF was not significantly associated to the quality of reporting of SS (t=1.974, P=0.051), RND (t=0.309, P=0.758), and STAT (t=-0.275, P=0.784). This finding could indicate that the quality of the journal did not assure the quality of the reporting these methods. However, there was a significant association between the assessed quality of the article measured with the Down's and Black checklist and the reporting of SS (χ2=29.149, DF=2, P<0.0001), RND (χ2=55.079, df=2, P<0.0001) and STAT (χ2=25.778, df=2, P<0.0001). Recent reporting quality of non-pharmacological rehabilitation RCTs was investigated. We found that the quality of the article but not the quality of the journal in which it is published in may be associated to the quality of reporting in sample size methods, randomization processes, and statistical analyses reporting. The quality of study reporting may be enhanced utilizing a guideline that addresses the required information in sample size calculation, randomization of individuals, and proper statistical analyses used and reported.

Health promotion interventions to improve oral health of adolescents: A systematic review and meta-analysis.

To evaluate the effectiveness of health promotion interventions on oral health knowledge, behaviour and status of healthy adolescents. This review included randomized controlled trials (RCTs) of oral health promotion interventions targeting adolescents. Primary clinical outcomes (gingival health, plaque scores, caries) and secondary proxy outcomes were evaluated. Meta-analysis of primary outcomes was conducted where possible, with subgroup analysis based on intervention (comprehensive health promotion and education-only). Thirty-seven eligible publications reporting on 28 unique RCTs of oral health promotion interventions were included. Quality appraisal of studies ranged from 48% to 96%. Interventions reported ranged from single-session interventions to community-wide programmes, including clinical preventive procedures and take-home products. Half used a health behaviour change theory to inform their intervention. The meta-analysis pooling of results favoured the intervention over control for all clinical outcomes, except DMFS in the education-only subgroup. Stronger intervention effects were seen in the comprehensive intervention subgroup than the education-only subgroup for DMFS (P=.02). This effect was slight, but not as clear in all other clinical categories. The majority of studies reported improvements in oral health knowledge, attitudes and behaviours. More positive outcomes were found with longer programmes, especially for dental caries outcomes. Oral health promotion programmes targeting adolescents have the ability to improve clinical oral health outcomes in the short and long term. Programmes should use more behavioural theory-based interactive and strategic methods, including self-awareness and the use of the wider community and peers for oral health promotion activities over a longer intervention duration.

Interventions outside the workplace for reducing sedentary behaviour in adults under 60 years of age

Interventions outside the workplace for reducing sedentary behaviour in adults under 60 years of age

Development of the PTSD-Repository: A Publicly Available Repository of Randomized Controlled Trials for Posttraumatic Stress Disorder.

Given the extensive research on posttraumatic stress disorder (PTSD) treatment, a single, updatable repository of data from PTSD treatment studies would be useful for clinical, research, and policy stakeholders. To meet this need, we established a preliminary dataset of abstracted PTSD trial data, which serve as the basis for the PTSD Trials Standardized Data Repository (PTSD-Repository), maintained by the National Center for PTSD (NCPTSD). We followed systematic review methods to identify published randomized controlled trials (RCTs) of PTSD interventions. We consulted with a panel of experts to determine a priori inclusion criteria, ensure that we captured all relevant studies, and identify variables for abstraction. We searched multiple databases for materials published from 1980 to 2018 and reviewed reference lists of relevant systematic reviews and clinical practice guidelines. In total, 318 RCTs of PTSD interventions that enrolled almost 25,000 participants were included. We abstracted 337 variables across all studies, including study, participant, and intervention characteristics as well as results. In the present paper, we describe our methods and define data elements included in the data tables. We explain coding challenges, identify inconsistencies in reporting across study types, and discuss ways stakeholders can use PTSD-Repository data to enhance research, education, and policy. The abstracted data are currently publicly available on the NCPTSD website and can be used for future systematic reviews and identifying research gaps and as an information resource for clinicians, patients, and family members.

Quality, scope and reporting standards of randomised controlled trials in Irish Health Research: an observational study

BackgroundDespite efforts to improve the accuracy and transparency of the design, conduct, and reporting of randomised controlled trials (RCTs), deficiencies remain. Such deficiencies contribute to significant, avoidable waste of health research investment and impede reproducibility. This study aimed to synthesise and critically analyse changes over time in the conduct and reporting of internationally published evidence on patient and/or population health-oriented RCTs conducted in one country.MethodsThis observational study drew on systematic review methods. We searched six databases for published RCTs (database inception to December 2018) where ≥ 80% of participants were recruited in the Republic of Ireland. RCTs of interventions targeted at patients, providers and/or policy makers intended to improve health, healthcare or health research were included. For each study, screening, data extraction and methodological quality appraisal were conducted by one member of the author team.ResultsFrom 17,560 titles and abstracts, 752 unique RCTs were published in 745 papers between 1968 and 2018, with a steady year-on-year increase since 1968. The number of participants was in the range of 2–8628. The majority were parallel design (86%) and classified as treatment evaluation. Of the 418 RCTs published since the introduction of mandatory clinical trial registration by the International Committee of Medical Journal Editors in 2005, 32% (n = 134) provided a trial registration number. This increased to 47% when taking studies published between 2013 and 2018 (n = 232). Since the 1996 publication of the CONSORT statement, 16% of included RCTs made specific reference to a standardised reporting guideline and this increased to 31% for more recent studies published between 2013 and 2018. Overall, 7% (n = 53) of studies referred to a published study protocol, increasing to 20% for studies published between 2013 and 2018.ConclusionEvidence from this single-country study of RCTs published in the international literature suggests that both the number overall, the number registered and the number referencing reporting guidelines have increased steadily over time. Despite widespread endorsement of reporting standards, reporting of RCTs remains suboptimal in domains such as compliance with the CONSORT statement and prospective trial registration. Researchers, funders and journal editors, nationally and internationally, should continue to focus on improving reporting and examining avoidable waste of health research investment.

Randomized Controlled Trials of Electronic Health Record Interventions: Design, Conduct, and Reporting Considerations.

Electronic health record (EHR) systems can be configured to deliver novel EHR interventions that influence clinical decision making and to support efficient randomized controlled trials (RCTs) designed to evaluate the effectiveness, safety, and costs of those interventions. In designing RCTs of EHR interventions, one should carefully consider the unit of randomization (for example, patient, encounter, clinician, or clinical unit), balancing concerns about contamination of an intervention across randomization units within clusters (for example, patients within clinical units) against the superior control of measured and unmeasured confounders that comes with randomizing a larger number of units. One should also consider whether the key computational assessment components of the EHR intervention, such as a predictive algorithm used to target a subgroup for decision support, should occur before randomization (so that only 1 subgroup is randomized) or after randomization (including all subgroups). When these components are applied after randomization, one must consider expected heterogeneity in the effect of the differential decision support across subgroups, which has implications for overall impact potential, analytic approach, and sample size planning. Trials of EHR interventions should be reviewed by an institutional review board, but may not require patient-level informed consent when the interventions being tested can be considered minimal risk or quality improvement, and when clinical decision making is supported, rather than controlled, by an EHR intervention. Data and safety monitoring for RCTs of EHR interventions should be conducted to guide institutional pragmatic decision making about implementation and ensure that continuing randomization remains justified. Reporting should follow the CONSORT (Consolidated Standards of Reporting Trials) Statement, with extensions for pragmatic trials and cluster RCTs when applicable, and should include detailed materials to enhance reproducibility.

Use of Sham Interventions in Randomized Controlled Trials in Neurosurgery.

The use of sham interventions in randomized controlled trials (RCTs) is essential to minimize bias. However, their use in surgical RCTs is rare and subject to ethical concerns. To date, no studies have looked at the use of sham interventions in RCTs in neurosurgery. This study evaluated the frequency, type, and indication of sham interventions in RCTs in neurosurgery. RCTs using sham interventions were also characterized in terms of design and risk of bias. From a total of 1,102 identified RCTs in neurosurgery, 82 (7.4%) used sham interventions. The most common indication for the RCT was the treatment of pain (67.1%), followed by the treatment of movement disorders and other clinical problems (18.3%) and brain injuries (12.2%). The most used sham interventions were saline injections into spinal structures (31.7%) and peripheral nerves (10.9%), followed by sham interventions in cranial surgery (26.8%), and spine surgery (15.8%). Insertion of probes or catheters for a sham lesions was performed in 14.6%.In terms of methodology, most RCTs using sham interventions were double blinded (76.5%), 9.9% were single blinded, and 13.6% did not report the type of blinding. Sham-controlled RCTs in neurosurgery are feasible. Most aim to minimize bias and to evaluate the efficacy of pain management methods, especially in spinal disorders. The greatest proportion of sham-controlled RCTs involves different types of substance administration routes, with sham surgery the less commonly performed.