Randomized Control Trial Design Research Articles

Influencing Canadian young adults to receive additional COVID-19 vaccination shots: the efficacy of brief video interventions focusing on altruism and individualism.

Younger adults, aged 18-39 years, exhibit low COVID-19 additional vaccine (i.e., vaccination beyond the original 2-dose series) uptake recommended in Canada. No study has examined how altruistic and individualistic messaging can influence COVID-19 additional dose intentions. The present study aimed to estimate the efficacy of altruism and individualism-based videos on vaccine intentions and to explore the multivariable associations between vaccine related individual psychosocial factors and intention to receive the COVID-19 vaccine. Using a web-based survey in a three-arm, pre-post randomized control trial design, we recruited Canadians aged 18-39 years in both English and French. Participants were randomly allocated in a 1:1:1 ratio to receive the active control (COVID-19 general information), control + altruism or control + altruism + individualism. The video interventions were developed with a media company, based on results of a focus group study conducted previously. The measurement of COVID-19 additional dosage intentions before and after completing the interventions was informed by the multistage Precaution Adoption Process Model. The McNemar Chi-square was used to evaluate within-group changes, and the Pearson Chi-square test was used to evaluate between-group changes post-intervention. The measurement of various psychosocial factors was informed by use of validated scale and self-report questions. We employed a generalized Structural Equation Model to evaluate the associations between COVID-19 vaccine intentions and the psychosocial factors. Analyses were performed on 3,431 participants (control: n = 1,149, control + altruism: n = 1,142, control + altruism + individualism: n = 1,140). Within-group results showed that participants transitioned significantly in all three groups in the direction of higher intentions for receiving additional COVID-19 vaccine doses. The between-group differences in post intervention vaccine intentions were not significant. We found that psychosocial factors that include, collectivism, intellectual humility, intolerance to uncertainty, religiosity, identifying as gender diverse, and being indigenous were associated with higher vaccine intentions, whereas pandemic fatigue was associated with lower vaccine intentions. Our study highlighted that a short video that includes altruism and individualism messaging or general COVID-19 information can increase intentions to vaccine among young adults. Furthermore, we gained a comprehensive understanding of various psychosocial factors that influence ongoing COVID-19 vaccination. Our findings can be used to influence public health messaging around COVID-19 vaccination.

An animated education program to reduce anxiety, vascular complications, and flat time among children undergoing cardiac catheterization: A randomized control trial, study protocol

One of the most dangerous and prevalent birth disorders is congenital heart defects (CHD). Children diagnosed with CHD may need many operations or medical treatments throughout their lives, including cardiac catheterization (CC). Children undergoing CC experience elevated levels of anxiety. Elevated levels of anxiety among children undergoing CC can be harmful to children physiologically, psychologically, and behaviorally. Additionally, vascular complications such as bleeding and hematoma represented the majority of complications among children undergoing CC. To achieve positive management outcomes, nurses must use an effective method to prepare children for CC. This study present the protocol for developing and implementing an animated education program (AEP) about CC on anxiety, vascular complications, and flat time among children undergoing CC for the first time. A Parallel Randomized Control Trial (RCT) design will be utilized to test the study hypotheses. It is an experimental design where participants are assigned randomly to either receive an intervention or not, and the outcome of interest is then evaluated after the intervention to assess its impact. The trial had been registered as Clinical Trails.gov PRS (Protocol Registration and Result system) Identifier: Protocol ID 101271-6 and clinical trials.gov ID (NCT06483087) under the brief title: Effect of Animated Education on Anxiety and Vascular Complications (VAEda) ClinicalTrials.gov Protocol Registration and Results System (PRS). A random sample of 98 children scheduled for a CC, whose ages range from 6 to 12 years old, will be recruited from a military hospital for medical and surgical heart disease in Jordan, with 49 children in the intervention group and 45 children in the control group. Children in the control group will receive routine care. However, children in the experimental group will receive an AEP, an 8-minute carton animated video that illustrates pediatric CC. The animated cartoon video was developed in Arabic using age-appropriate information. The study’s intervention is intended to give adequate information to children to prepare them for the events occurring before, during, and after the CC procedure, it will be presented to the intervention group 24 hours before the procedure. Outcome measures include anxiety levels that will be assessed 2 hours before children undergo CC. Bleeding and hematoma at the CC site will be assessed 2 hours postsheath removal, and flat time will be assessed by recording the hours that the child stays in a flat position postsheath removal. This exploratory experiment is a necessary first step in investigating important components of a full-scale clinical study. This study presents a novel technique designed for children undergoing CC to lower their anxiety, vascular complications, and flat time. The results of the current study provide evidence-based data that can improve nursing practice and research in pediatric cardiac nursing. Create a policy that emphasizes the critical role that nurses play in delivering high-quality health education through the use of AEP.

Evaluation of control arm quality in recent radiation oncology randomized clinical trials.

295 Background: Randomized controlled trials (RCTs) are designed to provide the highest levels of evidence for clinical practice; consequently, RCTs are the mainstay for creating guidelines and approving new treatments. It is ethically essential for patients assigned to the control arm in RCTs to receive standard-of-care treatment. This serves to protect patients, optimize adequate treatment, and ensures that RCT findings are compared to current standard-of-care therapy – an ethical imperative of RCT design and implementation. Oncologic medical trials investigating new systemic agents for cancer have a high proportion of RCTs with inadequate control arms (PMID 31046071). It is unknown whether this finding is prevalent in oncologic trials investigating radiation therapy (RT) for cancer. Methods: We identified registered clinical trials investigating RT in patients with cancer over the past decade. ClinicalTrials.gov was queried for RT as the intervention and cancer and other related terms as the condition between 1/1/13 and 1/1/23. Exclusion criteria included trials with incomplete status or non-oncologic indications. Trials were categorized by indication/primary disease site, first posted date, investigational arm, control arm, and sponsor/collaborator. Each control arm was analyzed, and the standard of care was determined according to National Comprehensive Cancer Center Network (NCCN) guidelines at the time of first posting on ClinicalTrials.gov. Results: A total of 508 interventional studies with results registered on ClinicalTrials.gov were included. Of these, 360 single-arm studies were excluded. 116 studies investigating a treatment other than RT were excluded. 20 studies that were not completed were excluded. The remaining 12 studies were included in the final analysis. Of the included trials, 2 each investigated RT usage in central nervous system, prostate, head and neck, and breast disease sites, and 1 each for lung, hepatobiliary, rectal, and bone disease sites. A majority of the trials were industry-funded (83%), and over 2/3 of studies took place in the United States (75%). 100% of the trials were found to have an adequate control arm per the corresponding NCCN guidelines. Conclusions: 100% of oncologic RCTs investigating radiation therapy for cancer were found to have an adequate control arm. This finding contrasts with medical oncology trials, which have been shown to have a high proportion of RCTs with inadequate control arms. This disparity highlights the importance of designing oncologic RCTs with adequate control arms, which is crucial for providing the highest level of evidence to guide optimal clinical practice and ensure the safety of patients. These findings indicate that the field of Radiation Oncology is ensuring ethical trial design with adequate control arm treatments and emphasizes the need for a continued focus on improving the quality of ethical oncologic research trials.

Assessing the Impact of Educational Strategies on Reducing Needle Stick Injuries for Nurses in Jordanian Hospitals

Background: Needle stick injuries (NSIs) are frequent occupational health hazards among nurses with several consequences including blood-borne infections. Literature indicates inadequate knowledge among nurses as an important associated risk factor. Notwithstanding, little attention has been given to the intervention programs to reduce the occurrences of NSIs in Jordan. The main objective of this research was to implement and assessing the impact of educational modules and strategies to minimize NSIs for nurses in Jordanian hospitals. Methods: a randomized control trial design with four arms including three intervention groups and one control group was applied. A total of 400 nurses were selected based on stratified random sampling from the four randomly sampled private hospitals. The educational intervention was then provided through three different strategies (Social Media (SM), Audio-Visual (AV), and combined method). Data were collected in three phases, at baseline, after three months, and after six months of the intervention. Results: There were statistically significant differences in the number of NSIs between the control and combined strategy groups (P= 0.002). After 6 months, significant differences were found between control and SM groups (P=0.032), control and AV groups (P= 0.007), and control and combined groups (P<0.001). The leading risk factors of NSIs included fatigue (P<0.001), lack of assistance (P= 0.001), emotional distress (P= .021), being rushed (P= .002), and Lack of skills (P= .001). The hierarchical regression for the prediction of changes in NSIs occurrence produced a model with four predictors after three months (P< .001), and six predictors after six months (P< .001). Conclusion: The educational intervention significantly decreased the occurrences of NSIs. Hospital administrators must consider significant risk factors for NSIs.

Targeted therapies, novel antibodies, and immunotherapies in advanced non-small cell lung cancer: clinical evidence and drug approval patterns.

Since 2011, the U.S. FDA has approved 30 new drugs for use in advanced non-small-cell lung cancer (NSCLC), mainly comprising tyrosine kinase inhibitors and immune checkpoint inhibitors. NSCLC with oncogene driver alterations is amenable to treatment with targeted drugs, usually small molecule inhibitors. In these cases, the demonstration of high overall response rates, coupled with a lasting duration of response, has allowed for accelerated approval in the U.S., based on single or multi-cohort trials. Confirmatory clinical evidence was subsequently provided through post-marketing trials. In NSCLC without such driver alterations, regulatory agencies in both the U.S. and the EU set clinical evidence expectations that foster the conduct of studies primarily focused on determining survival or event-free survival, based on randomized-controlled trial designs. This review analyzes the approval patterns of novel therapeutics for NSCLC with a focus on small molecule inhibitors that target driver alterations, as well as biologicals. The latter include monoclonal antibodies inhibiting immune checkpoints like PD-(L)1 or cell surface receptors, and antibody-drug conjugates, highly potent biologics linked to a cytotoxic compound. The differentiation of NSCLC into oncogene- and non-oncogene-addicted subtypes determines drug development strategies, the extent of the clinical development program, access to orphan drug development incentives, and regulatory approval strategies.

Comparative Efficacy of Biologics and Small Molecule in Ulcerative Colitis: A Systematic Review and Network Meta-analysis

Background & aimsTreatment options for moderate to severe ulcerative colitis (UC) are increasing rapidly, but the lack of comparative efficacy trials makes treatment choices a clinical challenge. This network-meta-analysis aimed to compare the relative efficacy of biologics and small molecules in achieving remission in patients with moderate to severe UC. MethodsThe literature was searched up to May 2024. Phase 3 placebo or active comparator randomized controlled trials (RCTs) were included. The primary outcome was induction and maintenance of endoscopic improvement (Mayo endoscopic score [MES] ≤1). Secondary outcomes were the induction and maintenance of clinical remission, endoscopic (MES = 0) and histological remission. A sub-analysis was performed based on the RCT design and previous exposure to biologic therapy. ResultsWe identified 36 studies that met our inclusion criteria, with 14,270 patients with UC. Upadacitinib ranked highest in inducing clinical remission (99.6%), and endoscopic improvement (99.2%), followed by risankizumab (91.4%) and (82.3%) respectively. In maintenance of endoscopic improvement, upadacitinib ranked first (98.6%) followed by filgotinib 200 mg (79.2%). Risankizumab ranked first in the induction of histological remission (89.4%). Followed by guselkumab (88.3%). Upadacitinib ranked first (93.1%) in maintaining histological remission followed by guselkumab (89.5%). ConclusionUpadacitinib appears to be superior to other therapies in achieving clinical remission, endoscopic improvement and remission, and histological remission. Furthermore, novel biologics such as risankizumab and guselkumab ranked high in achieving these outcomes. This study highlights the efficacy of small molecule drugs and novel selective IL-23s as alternatives to other biologics.

A combined program of education plus exercise versus general advice for ankle osteoarthritis: A feasibility randomised controlled trial

BackgroundUnlike hip and knee OA, there is little evidence to guide the management of ankle osteoarthritis (OA) and there are no clinical guidelines for ankle OA. Regardless of the body region, guidelines for treating OA typically include education, weight loss and exercise as the key components of management. Such an intervention has not been investigated in people with ankle OA. ObjectivesTo determine the feasibility of conducting a randomised controlled trial (RCT) that compares physiotherapist-delivered education plus exercise to physiotherapist-delivered general advice for people with ankle OA. Secondarily, to inform planning for future RCTs. DesignA randomised parallel-group feasibility trial. MethodStudy participants were recruited, assessed for eligibility, and randomised using 1:1 concealed allocation to receive either physiotherapist-delivered education plus exercise, or physiotherapist-delivered general advice. Primary feasibility outcomes were evaluated based on predetermined feasibility criteria. Secondary participant-reported and physical outcomes were collected to inform the design of future RCTs. ResultsThirty participants (67% (n = 20) women, mean (standard deviation) age: 66.1 (11.5) years) were randomised. Data for key feasibility outcomes met a priori feasibility criteria: consent rate (97%), participant adherence with their allocated intervention arm (71%), fidelity of the intervention (94%) and rate of completion of outcome measures at 3 months (87%). ConclusionsThis study demonstrates that it is feasible to run an adequately powered RCT comparing physiotherapist-delivered education plus exercise versus physiotherapist-delivered general advice for people with ankle OA. Study data will inform the planning of a full-scale RCT.

Exploring the Impact of Astaxanthin Supplementation in Conjunction with a 12-Week CrossFit Training Regimen on Selected Adipo-Myokines Levels in Obese Males.

Obesity is associated with an exacerbated metabolic condition that is mediated through impairing balance in the secretion of some adipo-myokines. Therefore, the objective of the present study was to explore the impact of astaxanthin supplementation in conjunction with a 12-week CrossFit training regimen on some selected adipo-myokines, insulin insensitivity, and serum lipid levels in obese males. This study is a randomized control trial design; 60 obese males were randomly divided into four groups of 15, including the control group (CG), supplement group (SG), training group (TG), and combined training and supplement group (TSG). The participants were subjected to 12 weeks of astaxanthin (AST) supplementation [20 mg/d capsule, once/d] or CrossFit training or a combination of both interventions. The training regimen comprised 36 sessions of CrossFit, each lasting 60 min, conducted three times per week. The metabolic indices, body composition, anthropometrical, cardio-respiratory, and also some plasma adipo-myokine factors, including decorin (DCN), activin A, myostatin (MST), transforming growth factor (TGF)-β1, and follistatin (FST), were examined 12 and 72 h before the initiation of the main interventional protocols, and then 72 h after the final session of the training protocol. There was no significant difference in the baseline data between the groups (p > 0.05). There were significant interactions between group x time for DCN (η2 = 0.82), activin A (η2 = 0.50), FST (η2 = 0.92), MST (η2 = 0.75), and TGFB-1 (η2 = 0.67) (p < 0.001 for all the variables). Significantly changes showed for DCN in TSG compared to TG and SG and also TG compared to SG (p = 0.0001); for activin A in SG compared to TG (p = 0.01) and TSG (p = 0.002); for FST in SG compared to TG and TSG (p = 0.0001), also in TSG compared to TG (p = 0.0001); for MST in SG, TG, and TSG compared to CG (p = 0.0001) and also in TSG compared to SG (p = 0.0001) and TG (p = 0.001); for TGFB-1 in SG, TG, and TSG compared to CG (p = 0.0001) and also TSG compared to SG (p = 0.0001) and TG (p = 0.001). The 12-week CrossFit training concurrent with AST supplementation reduced anthropometric and metabolic factors and also serum lipid levels while producing positive changes in body composition and cardiovascular factors. Increased FST and DCN and reduced activin A, MST, and TGF-β1 were other affirmative responses to both interventions.

Effect of tirzepatide on the progression of coronary atherosclerosis using MDCT: Rationale and design of the tirzepatide treatment on coronary atherosclerosis progression: The (T-Plaque) randomized-controlled trial design

Introduction: Tirzepatide is a novel once-week dual GIP/GLP-1 RA agonist approved for T2DM and its role to reduce cardiovascular events remains to be elucidated. The goal of this trial is to assess how tirzepatide affects the progression of atherosclerotic plaque as determined by multidetector computed tomography angiography (MDCTA). Methods: This trial is a double blind, randomized, prospective, placebo-controlled multi-center phase IV trial.Participant eligible for the study will be adults with T2DM between 40 and 80 years of age who have HbA1c ≥7.0% to ≤10.5% and at least 20% stenosis in major epicardial vessel on CCTA. Baseline examination will include the results of their demographics, lab tests, coronary calcium, as well as coronary plaque volume/composition. Following randomization, tirzepatide or placebo will be given at a weekly dose of 2.5 mg, and a fixed dose-escalation strategy will be followed. Patients will undergo quarterly visits for safety assessments and labs, and follow up with repeat CCTA at 1 year. Discussion: This study evaluates the anti-atherogenic potential of tirzepatide, providing a mechanism of potential CV benefit. This is crucial to our understanding of T2DM treatment and CVD since plaque progression portends worse outcomes in these populations. MDCTA is a noninvasive method that assesses the volume, composition, and degree of coronary vessel stenosis. Conclusion: This study will be the first study to assess the effects of tirzepatide on atherosclerotic plaque progression measured by MDCTA in participants with T2DM.

Endotracheal Intubation Performance in Novices: Comparing the Training Effect Resulting From Two Airway Management Training Simulators.

Between 2011 and 2014, the Combat Casualty Training Consortium research study sought to evaluate all aspects of combat casualty care, including mortality, with a special focus on the incidence and causes of potentially preventable deaths among American combat fatalities. This study identified a major training gap in critical airway management. Because of the high rate of morbidity and mortality associated with poor or incorrect airway management, an effort to address this training gap was necessary. This experiment compared the training using the Advanced Joint Airway Management System, a novel high-fidelity airway simulator, relative to one of the most utilized simulators for endotracheal intubation (ETI) via a parallel group randomized control trial design. Before training, participants (n = 19) attempted an ETI on a cadaver using direct laryngoscopy. Performance during the attempt was recorded and scored by trained blinded raters. Participants were then randomly allocated to either novel or conventional training. Post-training, participants completed a second ETI under the same parameters. Analysis was completed via 2 × 2 mixed analysis of variance for (1) ETI Score, (2) Errors, (3) Critical Failures, and (4) Duration, across both the pre- and post-training tests and between the two groups. A priori power analysis required a total sample size of 84 participants in this experimental design. Consequently, this study is under-powered to reach statistical significance. Scores for all trainees did improve with training, yet analyses did not reveal a difference in overall ETI score between the novel and conventional training group, at baseline or at the post-training test (P = .249). The Advanced Joint Airway Management System simulator presents a training effect that is comparable to the conventional training model. However, given this study's small sample size, these results must be considered preliminary and further research is merited to draw firm conclusions about its impact on trainee performance. Future studies engaging larger cohorts of trainees and exploring the other capabilities of the Advanced Joint Airway Management System (cricothyroidotomy, needle chess decompression) are needed to further examine the educational potential of this novel airway management training system.

A pilot pragmatic randomized controlled trial of a nicotine metabolite ratio-guided smoking cessation intervention in a lung health and screening program

IntroductionPatients with pulmonary nodules detected through lung cancer screening or as incidental findings are often followed in lung health and screening programs. The use of personalized pharmacotherapy for smoking cessation informed by the nicotine metabolite ratio (NMR), a measure of nicotine metabolism, has not yet been evaluated in this setting. This pilot randomized controlled trial (RCT) evaluated the feasibility of conducting a larger trial. MethodsThrough a pragmatic RCT design, participants were recruited from a Mid-Atlantic lung health and screening program. Eligible participants smoked >5 cigarettes per day and completed a blood draw to determine NMR before being randomized to standard or NMR-guided care treatment arms. Standard care participants were offered nicotine replacement therapy (NRT) or varenicline and a referral to phone-based smoking cessation counseling. NMR-guided participants received standard care except they were provided a personalized medication recommendation based on their NMR. Study outcomes included measures of feasibility, medication uptake, and treatment matching (i.e., uptake of the optimal medication). ResultsMore than 80 % of 205 screened patients were eligible. However, only 37 (22 %) of these patients enrolled in the study, with a mean age of 65 years, 43 % female, and 25 % Black. Nearly all patients who declined cited a disinterest in smoking cessation. Participants in both treatment arms had high rates of medication uptake (68 %), with NMR-guided participants showing a trend towards greater treatment matching (55 % vs. 29 %). ConclusionsThe results of this pilot study provide support for conducting a larger RCT of an NMR-guided smoking cessation intervention in a lung health and screening setting. Consideration should be given to augmenting the intervention to address barriers to study entry.

Evaluating the Efficacy of Psycho-Behavioral Interventions for Cardiovascular Risk among People Living with HIV: A Systematic Review and Meta-Synthesis of Randomized Controlled Trials.

People with HIV (PWH) are disproportionately affected by cardiovascular disease (CVD). Psycho-behavioral therapies are capable of targeting the pathophysiology underlying HIV-CVD comorbidity. This study synthesized findings from randomized controlled trials (RCTs) of psycho-behavioral therapies for reducing CVD risk among PWH following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Inclusion criteria were: (1) utilized an RCT design, (2) evaluated a cognitive-behavioral or mindfulness-based therapy, (3) sampled adults (age ≥18 years) with HIV, (4) measured a behavioral (e.g., diet) or biological (e.g., immune functioning) CVD risk factor, and (5) published in an English-language peer-reviewed journal. Electronic searches were conducted in six databases (e.g., MEDLINE) using controlled vocabulary and free-text synonyms for HIV, psycho-behavioral therapy, and CVD risk. Data were independently extracted with consensus reached. Outcomes were immune activation, tobacco-smoking, stress, inflammation, and physical activity from 33 studies. There were stronger effects for psycho-behavioral interventions compared to controls on CD4 (Hedge's g=0.262, 95% Confidence Interval [CI]=0.127, 0.396) and tobacco-smoking abstinence (Hedge's g=0.537, 95% CI=0.215, 0.86). There were no differences or insufficient data for stress, inflammation, or physical activity. No eligible studies examined psycho-behavioral interventions on blood pressure, lipids, or weight in PWH. There is increasing importance to further invest in broader CVD risk reduction effort for PWH that include psycho-behavioral intervention strategies.

Leveraging local knowledge to contextualize the opioid epidemic within HEALing Communities Study communities: A Photovoice protocol

Since its inception 30 years ago, Photovoice has gained increasing popularity as a research method and more recently has been incorporated within randomized controlled trial (RCT) designs. Photovoice is a participatory action research method that pairs photography with focus group discussions to record community strengths and concerns, build critical consciousness, and reach policymakers. Adherence of Photovoice implementation to these original tenets of Photovoice varies. This article provides the Photovoice protocol developed by the authors to improve the methodological rigor of Photovoice integration into RCTs and help contextualize the landscape for the HEALing Communities Study (HCS: NCT04111939), a greater than $350 million investment by the National Institute on Drug Abuse along with the Substance Abuse and Mental Health Services Administration to reduce opioid overdose deaths in 67 of the hardest-hit communities in four states (Kentucky, Massachusetts, New York, and Ohio). The product of a cross-state collaboration, this HCS Photovoice protocol provides ethical and methodological tools for incorporating Photovoice into RCT designs to enhance community engagement, communication campaigns, and data-driven decision-making about evidence-based practice selection and implementation.

Remotely-delivered exercise training program for improving physical and cognitive functions among older adults with multiple sclerosis: Protocol for an NIH stage-I randomized controlled trial

BackgroundOlder adults with multiple sclerosis (MS) present with low physical activity participation, cognitive and ambulatory dysfunctions, and compromised quality of life (QOL). ObjectiveWe propose a NIH Stage-I, randomized controlled trial (RCT) that examines the feasibility and efficacy of a 16-week theory-based, remotely-delivered, exercise training program for improving cognitive and physical functions in older adults with MS who have moderate mobility disability without severe cognitive impairment. MethodsThis Stage-I study utilizes a parallel-group RCT design. Participants (N = 50; age ≥ 50 years) will be randomly assigned into exercise training (combined aerobic and resistance exercise) or active control (flexibility and stretching) conditions. The conditions will be undertaken within a participant's home/community over a 16-week period, and monitored remotely and supported by Zoom-based chats guided by social cognitive theory (SCT) via a behavioral coach. Participants will receive training manuals and equipment, one-on-one behavioral coaching, action-planning calendars, self-monitoring logs, and SCT-based newsletters. The primary outcomes include feasibility (e.g., recruitment and retention rates), exercise behavior and physical activity; other outcomes include physical function (lower-extremity function, mobility, walking), cognition (processing speed, learning and memory, executive function), MS symptoms, QOL, and vascular function. We will collect outcome data at baseline (Week 0), post-intervention (Week 16), and follow-up (Week-32). Data analysis will follow intent-to-treat principles using linear mixed-effects models. DiscussionThis Stage-I trial adopts an innovative approach for exercise training via telerehabilitation and is convenient and accessible for older adults with MS. If successful, the study will provide foundations for future research using remotely-delivered exercise intervention for managing the consequences of aging with MS.Trial Registration Number:NCT05930821

The effect of antenatal hypnosis training on pharmacological analgesia use during labour and birth: A systematic review and meta-analysis

BackgroundThe use of hypnosis as a means of pain management during labour is becoming increasingly popular. While recent reviews have reported on pain perception, relaxation and other psychological benefits the impact of hypnosis on the use of pharmacological analgesia use has not been specifically examined. QuestionFor women in labour at term, does antenatal hypnosis instruction compared to no instruction result in decreased use of pharmacological analgesia and influence maternal and infant birth outcomes. MethodsDatabases such as PubMed, CINAHL, Cochrane Central Register of Controlled Trials and Embase were searched with dates ranging from 1947-2024. We included randomised controlled trials (RCTs) that compared antenatal hypnosis training to no hypnosis control groups, published in English and reported on pharmacological analgesia use. The Cochrane's Risk of Bias 2 for RCTs was used to assess design quality. Study selection, quality assessment, data extraction and analysis were undertaken by two independent researchers. FindingsSix RCTs met the inclusion criteria (n=2937). The use of hypnosis did not result in a significant reduction in the risk of epidural use (RR. 0.79 95% CI 0.39-1.61) or other forms of pharmacological analgesia. Factors such as blinding of care providers to the participants allocated group may have reduced the chances of successful use of hypnosis. Variations in the presentation of hypnosis between studies may also impact on outcomes. Discussion and ConclusionThis review reports no effect on the use of pharmacological analgesia in women trained in hypnosis antenatally compared with those who were not. Our review does highlight several RCT design characteristics that could impact on the measurement and analysis of the use and efficacy of hypnosis.

The Relational Approach to Treating Self-Harm (RELATE): study protocol for a feasibility randomised controlled trial study of cognitive analytic therapy for adults who self-harm versus treatment at usual

BackgroundSelf-harm is a prevalent behaviour that has a major detrimental impact on a person’s life. Psychological therapies have the potential to help, but evidence of effective interventions remains limited. Access and acceptability of interventions can also be a significant challenge, with individuals either being unable to access help or having to endure long waiting lists. Cognitive analytic therapy (CAT) is a time-limited and relationally-focused psychotherapy that may provide a valuable treatment option for people who self-harm. This protocol outlines the methodology for the first feasibility randomised controlled trial (RCT) of CAT for adults that self-harm. The trial will aim to determine the feasibility, acceptability and safety of undertaking larger-scale evaluations of CAT for self-harm within an RCT context.MethodAn RCT design with 1:1 allocation to CAT plus treatment as usual (TAU) or TAU alone. Participants will be adult outpatients with three or more instances of self-harm in the past year (target sample of n = 60). CAT will be 8 one-to-one weekly 60-min sessions plus a follow-up session up to 8 weeks after the last session. Assessments will occur at baseline, 12 weeks and 18 weeks after randomisation. Qualitative interviews with participants will gain insights into the feasibility and acceptability of CAT. Feasibility outcomes will be judged against progression criteria.DiscussionCAT may be an effective and accessible treatment option for people who self-harm, providing a more relationally orientated alternative to more behavioural therapies. The proposed feasibility RCT is an important first step in evaluating CAT as a treatment for self-harm.Trial registrationThe trial was pre-registered (21/10/22) on ISR CTN (ISRCTN code: ISRCTN75661422).

RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial: Study rationale and design

Out-of-hospital cardiac arrest (OHCA) occurs in nearly 350,000 people each year in the United States (US). Despite advances in pre- and in-hospital care, OHCA survival remains low and is highly variable across systems and regions. The critical barrier to improving cardiac arrest outcomes is not a lack of knowledge about effective interventions, but rather the widespread lack of systems of care to deliver interventions known to be successful. The RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial is a 7-year pragmatic, cluster-randomized trial of 60 counties (57 clusters) in North Carolina using an established registry and is testing whether implementation of a customized set of strategically targeted community-based interventions improves survival to hospital discharge with good neurologic function in OHCA relative to control/standard care. The multi-faceted intervention comprises rapid cardiac arrest recognition and systematic bystander CPR instructions by 9-1-1 telecommunicators, comprehensive community CPR training and enhanced early automated external defibrillator (AED) use prior to emergency medical systems (EMS) arrival. Approximately 20,000 patients are expected to be enrolled in the RACE CARS Trial over 4 years of the assessment period. The primary endpoint is survival to hospital discharge with good neurologic outcome defined as a cerebral performance category (CPC) of 1 or 2. Secondary outcomes include the rate of bystander CPR, defibrillation prior to arrival of EMS, and quality of life. We aim to identify successful community- and systems-based strategies to improve outcomes of OHCA using a cluster randomized-controlled trial design that aims to provide a high level of evidence for future application.

Impact of Tai Chi and Aerobic Exercise on Cognitive Function, Balance, Cardiovascular Fitness, and Quality of Life in Older Adults: Randomized Control Trial.

Introduction Tai chi, an ancient Chinese martial art, was originally developed for combat and self-defense. Over time, it has evolved into both a sport and a form of exercise. This gentle, low-impact exercise involves performing a series of deliberate, flowing motions while focusing on deep, slow breaths. This study investigates the effects of chen tai chi and aerobic exercises on cognition, balance, cardiopulmonary fitness, and quality of life in older adults. Methodology This study employed a single-blinded randomized control trial design, enrolling 60 participants aged between 60 and 75 years. Participants were divided into three groups: Group A (aerobics), Group B (chen tai chi), and Group C (control). Exercise sessions were held four days per week over a period of four weeks. Evaluations included the Montreal Cognitive Assessment for cognition, a one-leg stand test for static balance, a Timed Up and Go Test for dynamic balance, a six-minute walk test for cardiopulmonary fitness, and a health-related quality-of-life scale. Assessments were conducted at baseline, immediately after the intervention, and at follow-up was taken after eight weeks. Results Post-intervention, improvements were observed in cognition and static balance across all groups. Within-group analysis revealed that the aerobics group experienced statistically significant enhancements in cognition (p = 0.0001) and static balance (p = 0.01). Although no statistically significant differences were found between groups in terms of dynamic balance, cardiopulmonary fitness, and quality of life, the within-group analysis showed significant improvements in the aerobics group in dynamic balance (p = 0.0009), cardiopulmonary fitness (p = 0.03), and quality of life (p = 0.0001). Conclusion Compared to chen tai chi and no intervention, the study concludes that aerobic exercise has a more pronounced effect on improving cognition, balance, cardiopulmonary fitness, and quality of life in older adults. Aerobic exercise is recommended as an effective method to prevent frailty and promote independence among the elderly.

Addressing missing outcome data in randomised controlled trials: A methodological scoping review

BackgroundMissing outcome data is common in trials, and robust methods to address this are needed. Most trial reports currently use methods applicable under a missing completely at random assumption (MCAR), although this strong assumption can often be inappropriate. ObjectiveTo identify and summarise current literature on the analytical methods for handling missing outcome data in randomised controlled trials (RCTs), emphasising methods appropriate for data missing at random (MAR) or missing not at random (MNAR). Study design and settingWe conducted a methodological scoping review and identified papers through searching four databases (MEDLINE, Embase, CENTRAL, and CINAHL) from January 2015 to March 2023. We also performed forward and backward citation searching. Eligible papers discussed methods or frameworks for handling missing outcome data in RCTs or simulation studies with an RCT design. ResultsFrom 1878 records screened, our search identified 101 eligible papers. 90 (89%) papers described specific methods for addressing missing outcome data and 11 (11%) described frameworks for overall methodological approach. Of the 90 methods papers, 30 (33%) described methods under the MAR assumption, 48 (53%) explored methods under the MNAR assumption and 11 (12%) discussed methods under a hybrid of MAR and MNAR assumptions. Control-based methods under the MNAR assumption were the most common method explored, followed by multiple imputation under the MAR assumption. ConclusionThis review provides guidance on available analytic approaches for handling missing outcome data, particularly under the MNAR assumption. These findings may support trialists in using appropriate methods to address missing outcome data.

Using PRECIS-2 in Chinese herbal medicine randomized controlled trials for irritable bowel syndrome: A methodological exploration based on literature

BackgroundThe pragmatism levels of randomized controlled trials (RCTs) mean how similar the interventions delivered in the trial setting match those in the setting where the results will be applied. We aimed to investigate the association between the consistency of pragmatism among the characteristics of RCT design and its effect size of results in Chinese herbal medicine (CHM) for irritable bowel syndrome (IBS). MethodsEight English and Chinese language databases were searched for RCTs on CHM for IBS. Six reviewers independently assessed the pragmatism of trials using the pragmatic-explanatory continuum indicator summary 2 (PRECIS-2) tool. The consistency of pragmatism levels among the characteristics of RCT design was calculated using the coefficient of variation. Linear regression models were adopted to explore influence factors of the pragmatism of RCTs. Results78 RCTs were included. The level of consistency in the pragmatism for RCT's design was significantly correlated with the effect size of the results (binary outcome, r = -0.413; P = 0.005; continuous outcome, r = -0.779, P < 0.001). PRECIS-2 score was higher in trials with individualized interventions than fixed interventions (3.29 [0.32] vs 2.90 [0.32]; Cohen's d relative effect size, 0.52; P < 0.001) and in standard or usual-treatment-controlled trials than placebo-controlled (3.05 [0.37] vs 2.83 [0.28]; Cohen's d relative effect size, 0.32; P = 0.048). ConclusionThe consistency of pragmatism level across the 9 domains of the PRECIS-2 tool in CHM IBS RCTs was positively correlated with the effect size of the results.