Stepped Wedge Research Articles

Cast-OFF 2: One Week Versus 3-5 Weeks of Plaster Cast Immobilization for Non- or Minimally Displaced Distal Radius Fractures-A Stepped Wedge Cluster Randomized Controlled Trial.

Implementation of 1 week of cast immobilization followed by gradually increasing wrist mobilization for non- or minimally displaced distal radius fracture (DRF) and comparison of the functional outcomes and pain scores with the usual care (3-5 weeks of cast immobilization). A randomized stepped wedge cluster design, prospective cohort. Academic and peripheral hospitals in levels 1, 2, and 3 trauma centers. All patients between 18 and 85 years old with an isolated non- or minimally and nonreduced DRF were eligible for inclusion. Participating hospitals were randomized to transition from usual care (3-5 weeks of cast immobilization) to 1 week of cast immobilization, following the stepped wedge design. Patient characteristics, secondary dislocation, surgical treatment, visual analog scale, Patient Rated Wrist Evaluation (PRWE), Patient Reported Outcomes Measurement Information System Pain Interference, Pain Catastrophizing Scale 4, and patient satisfaction were compared between control and intervention group at weeks 1, 3-5, 6, months 3, 6, and 12. A difference around 11 points on the PRWE scale was considered clinically significant. Four hundred two patients were included (control n = 197 vs. intervention n = 205, 267/135, female/male). There were no differences in age (53.7 ± 18.6 vs. 53.3 ± 19.5, P = 0.27), sex (66% vs. 67% female, P = 0.44), dominant hand fractured (44% vs. 53%, P = 0.39), and type of fracture (39% vs. 41% extra-articular, P = 0.44). After 6 weeks, the PRWE score showed no clinically significant differences (-4.5 [confidence interval -12.9 to 4.02], P = 0.30). No significant differences were observed for function, pain scores, and patient satisfaction between groups (all P > 0.05). Furthermore, there was no significant difference in secondary dislocation rate (control 1.5% vs. intervention 1.0%, P = 0.32) and operation rate (control 1.5% vs. 1.5% intervention, P = 0.92). This study compared 1 week of cast immobilization followed by gradually increasing wrist mobilization to the usual care of 3-5 weeks for nonreduced DRF. No clinically significant differences in function, pain scores, patient satisfaction, secondary dislocation, and operations were observed. Therefore, 1 week of plaster immobilization can be safely recommended for the non- or minimally displaced and nonreduced DRF treatment. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

P-315. Safety and Effectiveness of Nasal Povidone-Iodine Decolonization Among Patients on Hemodialysis: A Multicenter Stepped-Wedge Cluster Randomized Trial

Abstract Background The SHEA/IDSA/APIC Strategies to Prevent MRSA Transmission and Infection Practice Recommendations advised that facilities consider decolonizing patients on hemodialysis. We implemented a nasal decolonization intervention in which patients self-administered povidone-iodine (PVI) at each dialysis session. We aimed to assess intervention safety and effectiveness. Methods We performed a stepped wedge cluster randomized trial at 16 outpatient hemodialysis units affiliated with 5 academic medical centers between 2020-2023. Adverse events were self-reported at 1 and 6 months. While the analysis was at the hemodialysis unit level, patients were required to give verbal informed consent for PVI use. Outcomes included National Healthcare Safety Network reportable dialysis events aggregated at hemodialysis unit level, including bloodstream infections (BSI), access-related BSI, and central venous catheter (CVC) BSI for all pathogens and for Staphylococcus aureus (SA). The primary outcome was SA BSI. A generalized linear mixed model with a negative binomial distribution, log link function, and an offset for person-months with a random intercept for each hemodialysis unit was performed. Results Overall, 1,351 patients received hemodialysis at these centers each month. Of those, 362 patients verbally consented to use PVI. Among these, 3.9% reported side effects: nasal drip, congestion or burning/stinging, unpleasant smell, headache, or minor nose bleed. A reported side effect ‘yellow tears’ was assessed via chart review and resolved by discontinuing PVI. There were no statistically significant associations between unit level randomization to the PVI intervention and infections. However, there was a non-statistically significant trend toward a protective association between unit-level randomization to PVI and SA infections, particularly SA CVC BSI.(Table) Conclusion Long-term nasal decolonization with PVI was safe with few adverse events. Unit level randomization to the PVI intervention did not significantly decrease unit-level infections. Given low patient enrollment and added infection prevention interventions due to COVID-19, the study could not determine if PVI decolonization could decrease BSI rates in the hemodialysis setting. Disclosures Marin Schweizer, PhD, 3M: Grant/Research Support Anitha Vijayan, MD, Baxter: Honoraria|NxStage: Advisor/Consultant|Qanta: Honoraria David A. Pegues, MD, DaVita/Total Renal Care: Advisor/Consultant Daniel Diekema, MD, Affinity Biosensors: Grant/Research Support|bioMerieux, Inc: Grant/Research Support Loreen Herwaldt, MD, 3M: Grant/Research Support|PDI: Grant/Research Support

Physical, chemical and biological properties of MTA Angelus and novel AGM MTA: an in vitro analysis

IntroductionMineral trioxide aggregate (MTA) is a calcium silicate-based cement that has changed conventional dental therapeutic approaches. This study aimed to evaluate physical, chemical and biological properties of novel AGM MTA, in comparison with MTA Angelus.MethodsThe samples were prepared according to the manufacturer’s instructions. The initial and final setting times were measured via a Gillmore needle following the ISO 6876:2012 standard. The radiopacity of the materials was evaluated against an aluminium step wedge on the basis of the ISO 6876 and 13,116 standards. The pH changes were measured at intervals of 3, 6, 24, 72, 96 and 144 h postimmersion in Hank’s solution and calcium ion release was analysed after 168 h of immersion via inductively coupled plasma optical emission spectroscopy (ICP‒OES). Moreover, the cytotoxicity was assessed through the MTT assay on human dental pulp stem cells (hDPSCs) after 24 and 72 h of exposure to the set/fresh status of various dilutions of MTA extracts, following the ISO 10993-12 standard.ResultsNo significant difference was found between the initial setting times of the two materials (Angelus: 11.0 ± 1.0 min, AGM: 10.3 ± 1.5 min); however, MTA Angelus demonstrated a significantly shorter final setting time. Both materials met the minimum radiopacity requirements according to the ISO 6876 standard, with MTA Angelus exhibiting greater radiopacity than AGM MTA. Both materials created an alkaline environment without presenting any differences in each time point and AGM MTA released significantly greater amounts of calcium ions. In the cytotoxicity assessment, while the diluted extracts of both materials did not elicit any cytotoxic effects, the nondiluted samples, after 72 h of exposure, as well as the 30-min set AGM MTA after 24 h of exposure, were shown to be cytotoxic.ConclusionsIn conclusion, MTA Angelus presented a faster setting time and lower cytotoxicity, while AGM MTA demonstrated greater calcium ion release. However, both materials presented clinically acceptable properties and AGM MTA could be a potential alternative to MTA Angelus. However, further clinical studies are required to confirm its application.

Using behavioural science to improve antibiotic stewardship in Canadian long-term care homes: Protocol for a multi-center cluster randomized quality improvement study.

Antimicrobial resistance (AMR) is associated with significant human and financial costs, particularly among vulnerable populations like older adults living in long-term care homes (LTCHs). Urinary tract infection (UTI) is the leading indication for antibiotic use in this population, with some estimates suggesting that up to 70% of these prescriptions may be avoidable. The purpose of this study is to develop and test novel behavioural science-informed antimicrobial stewardship (AMS) quality improvement strategies in Canadian LTCHs, which aim to decrease unnecessary testing and treatment for residents who lack the minimum clinical signs and symptoms of UTI. The quality improvement strategy is a two-pronged approach that includes 1) targeted education for essential care providers (family and friends of LTCH residents) about UTI and benefits of AMS, which strives to outline a positive role for this group in UTI management, and 2) monthly feedback to LTCH staff on their facility's urine culture ordering rates. The protocol was piloted in a single LTCH; a process evaluation of the pilot implementation served to refine the research protocol, which is being implemented in eight LTCHs across Canada using an eight-month stepped wedge randomized cluster design. This protocol represents a behavioural science-informed intervention to improve AMS across LTCHs. If successful, this model of care could be scalable across Canadian LTCHs, offering an inclusive approach that aims to empower clinicians, non-regulated healthcare staff, residents and their family and friends to improve health outcomes as antibiotic stewards.

Multilevel intervention for follow-up of abnormal FIT in the safety-net: IMProving Adherence to Colonoscopy through Teams and Technology (IMPACTT).

Fecal immunochemical testing (FIT) is a widely used first step for colorectal cancer (CRC) screening. Abnormal FIT results require a colonoscopy for screening completion and CRC diagnosis, but the rate of timely colonoscopy is low, especially among patients in safety-net settings. Multi-level factors at the clinic- and patient-levels influence colonoscopy completion after an abnormal FIT. Our study aims to implement a multi-level approach consisting of a clinic- and patient-level intervention to improve the completion of diagnostic colonoscopy after an abnormal FIT. We will test a multilevel intervention with one safety-net system across 12 primary care clinics - a clinic-level intervention using a stepped wedge design and a patient-level intervention with patient-level randomization. At the clinic level, we will implement a "best practices bundle" to improve workflow for primary care providers and staff using a stepped-wedge design. At the patient level, we will randomize 2000 patients to receive text messages and call reminders or usual care. For the main analysis, we will use a mixed effects logistic model to assess the impact of the clinic intervention on the primary outcome (completion of colonoscopy within 180 days after abnormal FIT). Secondary outcomes include median days to colonoscopy completion, rate of referral to colonoscopy at 42 days, rate of scheduled colonoscopy at 56 days, and bowel preparation quality at colonoscopy. This study will assess the extent to which a multi-level intervention can improve timely colonoscopy completion in a diverse patient population cared for in a safety-net setting. NCT, NCT06191185. Registered 20 December 2023, https://clinicaltrials.gov/study/NCT06191185.

Exploring the mechanism of change in exercise behavior during a theory-based exercise intervention among community-dwelling (pre)frail older adults: A stepped wedge cluster randomized trial.

This study evaluated the effectiveness of a theory-based exercise intervention on exercise beliefs and behavior, and clarified the underlying mechanism of the exercise intervention among community-dwelling (pre)frail older adults. A 12-week exercise intervention based on the integration of Health Belief Model, Theory of Planned Behavior and Health Action Process Approach was implemented to 149 participants. The positive effects were significant on exercise beliefs (β = -1.630 - 3.500, P < 0.05) and exercise behavior (β = 0.851, P < 0.001), and most of them persisted at 12- and 24-week postintervention. Furthermore, perceived barriers (β1β2 = 0.118, P = 0.037) and descriptive norms (β1β2 = 0.144, P = 0.047) mediated the relationship between exercise intervention and exercise behavior. The theory-based exercise intervention improves exercise beliefs and behavior, and perceived barriers and descriptive norms play a crucial role in increasing exercise behavior among the target population.

Study protocol for a multi-center stepped-wedge cluster randomized trial to explore the usability and outcomes among young people living with HIV in Kiambu and Kirinyaga counties of Kenya, using an online health portal.

While the incidence of Human Immunodeficiency Virus (HIV) infection is decreasing in most age groups worldwide, it is rising among adolescents and young adults, who also face a higher rate of HIV-related deaths. This tech-savvy demographic may benefit from an online patient portal designed to enhance patient activation-empowering them to manage their health independently. However, the effectiveness of such digital health interventions on young HIV patients in Kenya remains uncertain. We will conduct a 12-month stepped wedge cluster randomized trial involving 15-24-year-old HIV patients with smartphone access. The primary outcome will be patient activation, with secondary outcomes including self-reported adherence, social engagement and viral suppression. We will also evaluate the portal's functionality, usability, fidelity, and costs. Participants will be recruited from 47 antiretroviral treatment (ART) sites with electronic medical records (EMR), forming 16 clusters of 30 participants each. Clusters will be randomized into three sequences for intervention every three months. Baseline measurements (patient activation, adherence, social engagement and viral suppression) will be collected over two weeks, followed by checks at 3, 6, and 12 months. Data will be analyzed using generalized linear mixed models and adjusted for cluster effects and potential confounders. Results will be disseminated through stakeholder forums, scientific conferences, peer-reviewed publications, and the media.

Serum GFAP and UCH-L1 for the identification of clinically important traumatic brain injury in children in France: a diagnostic accuracy substudy

Many children with mild traumatic brain injury (mTBI), defined by a Glasgow Coma Scale (GCS) score between 13 and 15, undergo hospitalisation or cranial CT (CCT) scans despite the absence of clinically important traumatic brain injury (ciTBI; ie, hospitalisation >2 days associated with intracranial lesions on CCT, neurosurgical intervention, intensive care admission, or death). Clinical algorithms have reduced CCT scans and hospitalisations by 10%. We aimed to established age-appropriate reference values for GFAP and UCH-L1 and evaluate their diagnostic test performance in identifying ciTBI in children. This study was a diagnostic test accuracy substudy within the PROS100B stepped wedge cluster randomised trial that included children aged 16 years or younger, clinically managed within 3 h of mTBI, with a GCS score of 15 requiring hospitalisation or CCT scan according to French Pediatric Society guidelines (equivalent to the intermediate risk group of the PECARN algorithm). Enrolment for PROS100B occurred from Nov 1, 2016, to Oct 31, 2021, at 11 hospital emergency departments in France. Stored blood samples collected from March 1, 2015, to Oct 31, 2015, from children aged 16 years or younger who were outpatients for allergic conditions unrelated to mTBI and free of neurological disease were used as a control group to calculate reference values of GFAP and UCH-L1 across four age groups (<6 months, 6 months to <2 years, 2 years to <4 years, and 4 years to <16 years). The diagnostic test performance of GFAP and UCH-L1, both above the reference range to identify ciTBI, was evaluated in the children with mTBI. GFAP and UCH-L1 were measured with the Alinity analyser (Abbott, Chicago, IL, USA). Reference values were calculated from GFAP and UCH-L1 measured in samples from 718 control children (378 [53%] boys and 340 [47%] girls). 531 children (334 [63%] boys and 197 [37%] girls) aged 0-16 years with mTBI were included. By applying our reference values for GFAP and UCH-L1 across four age groups the biomarker combination (both biomarkers above reference ranges) had a sensitivity of 100% (95% CI 69-100), a negative predictive value of 100% (99-100), a specificity of 67% (63-71), a positive likelihood ratio of 3·01 (2·67-3·40), a negative likelihood ratio of 0, and an area under the curve of 0·83 (0·81-0·85) in identifying ciTBI. Serum GFAP and UCH-L1 identify ciTBI in children with 100% sensitivity and 67% specificity, which could potentially reduce unnecessary CCT scans and hospitalisations in children with mTBI if implemented. French Ministry of Health.

The IMproving treatment decisions for Patients with AortiC stenosis Through Shared Decision Making (IMPACT SDM) Study: study protocol for a cluster randomized stepped wedge trial

BackgroundThe American College of Cardiology, American Heart Association, and Centers for Medicare and Medicaid Services recommend shared decision-making (SDM) for patients with severe aortic stenosis choosing between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). Although tools such as patient decision aids (DAs) and training in SDM have been shown to improve SDM, implementation of SDM and DAs is limited. The IMproving treatment decisions for Patients with AortiC stenosis Through Shared Decision Making (IMPACT SDM) study aims to (1) determine the effectiveness of the interventions (a DA and clinician SDM training) in achieving SDM (primary outcome) and improving the quality of decisions about aortic valve replacement, (2) determine the reach of the DAs and adoption of training, and (3) explore potential mechanisms of effectiveness and implementation at the patient-, clinician-, and clinic-level.MethodsThe study is a hybrid type II effectiveness-implementation study using a cluster randomized batched stepped wedge trial with 8 sites across the USA. Eligible patients will be surveyed before and after visits with the heart valve team; clinicians will be surveyed after visits. Reach of DAs and adoption of training will be tracked. Clinicians will be interviewed regarding barriers and facilitators to implementation.DiscussionThe IMPACT SDM Study seeks to provide evidence of the ability of the interventions to improve SDM and decision quality, and also to shed light on barriers and facilitators to SDM implementation to promote future implementation efforts.Trial registrationClinicalTrials.gov NCT06171737. Registered on December 15, 2023.

A Systematic Review of Stepped Wedge Cluster Randomized Trials in High Impact Journals: Assessing the Design, Rationale, and Analysis

ObjectiveStepped wedge cluster randomized trials (SW-CRTs) are an appealing study design because they enable sequential roll out of an intervention across clusters, bringing logistical advantages. This review aimed to evaluate the design rationale, design features, stepped wedge diagram, and analytical approaches of SW-CRTs published in high-impact medical journals from 2020 to 2023, focusing particularly on adherence to key guidelines from the CONSORT extension to SW-CRTs. Study Design and SettingWe conducted searches across PubMed and Cochrane Central Registry of Controlled Trials (CENTRAL) databases for SW-CRTs published between January 2020 and December 2023 in eight high-impact journals. Eligibility criteria included peer-reviewed publications of randomised SW-CRTs involving human participants, published in English. ResultsOf the 23 SW-CRTs included in the review, 70% had "stepped wedge" explicitly mentioned in their titles. Most studies (96%) included a stepped wedge diagram, but only 65% of these diagrams clearly communicated the duration of each time period. There was considerable variability in design features, including number of sequences (median of 7, range 3-20) and clusters (median of 15, range 9-19). The majority of trials (78%) provided robust justifications for selecting SW-CRT design, for example citing practical or logistical constraints. However, 22% of the studies offered less convincing rationales. Generalized linear mixed models (GLMMs) were the most frequent analysis method employed. ConclusionOur review has highlighted areas for improvement in the presentation of SW-CRTs, particularly in clearly indicating the duration of time periods within diagrams and providing robust justifications for selecting a SW-CRT design.

Efficient designs for three-sequence stepped wedge trials with continuous recruitment.

The standard approach to designing stepped wedge trials that recruit participants in a continuous stream is to divide time into periods of equal length. But the choice of design in such cases is infinitely more flexible: each cluster could cross from the control to the intervention at any point on the continuous time-scale. We consider the case of a stepped wedge design with clusters randomised to just three sequences (designs with small numbers of sequences may be preferred for their simplicity and practicality) and investigate the choice of design that minimises the variance of the treatment effect estimator under different assumptions about the intra-cluster correlation. We make some simplifying assumptions in order to calculate the variance: in particular that we recruit the same number of participants, , from each cluster over the course of the trial, and that participants present at regularly spaced intervals. We consider an intra-cluster correlation that decays exponentially with separation in time between the presentation of two individuals from the same cluster, from a value of for two individuals who present at the same time, to a value of for individuals presenting at the start and end of the trial recruitment interval. We restrict attention to three-sequence designs with centrosymmetry - the property that if we reverse time and swap the intervention and control conditions then the design looks the same. We obtain an expression for the variance of the treatment effect estimator adjusted for effects of time, using methods for generalised least squares estimation, and we evaluate this expression numerically for different designs, and for different parameter values. There is a two-dimensional space of possible three-sequence, centrosymmetric stepped wedge designs with continuous recruitment. The variance of the treatment effect estimator for given and can be plotted as a contour map over this space. The shape of this variance surface depends on and on the parameter , but typically indicates a broad, flat region of close-to-optimal designs. The 'standard' design with equally spaced periods and 1:1:1 allocation rarely performs well, however. In many different settings, a relatively simple design can be found (e.g. one based on simple fractions) that offers close-to-optimal efficiency in that setting. There may also be designs that are robustly efficient over a wide range of settings. Contour maps of the kind we illustrate can help guide this choice. If efficiency is offered as one of the justifications for using a stepped wedge design, then it is worth designing with optimal efficiency in mind.

Improving colonoscopy quality in the national VA healthcare system.

Colorectal cancer (CRC) prevention is a Veterans Affairs (VA) priority. Colonoscopy quality, especially adenoma detection rate (ADR), is critical for effective screening. Our research indicates considerable variation in ADR among VA providers. Even a slight increase in ADR can reduce fatal CRC rates, and audit and feedback strategies have improved ADR in other settings. A recent report identified deficiencies in VA colonoscopy quality, highlighting the need for standardized documentation and reporting. To address this, we developed the VA Endoscopy Quality Improvement Program (VA-EQuIP), which aims to improve colonoscopy quality through benchmarking and collaborative learning, aligning with VA's modernization priorities and HSR&D and QUERI goals of accelerating evidence-based implementation. We will conduct a stepped wedge cluster randomized trial to evaluate whether VA-EQuIP improves provider ADR compared to usual care, the implementation of VA-EQuIP, site-level factors associated with colonoscopy quality improvement, and components of provider behavior change. Using mixed methods our study will measure outcomes like reach, implementation, adoption, maintenance of VA-EQuIP, and provider behavior change. The analysis will include primary and secondary outcomes, such as overall and screening ADR, cecal intubation rate, and bowel preparation quality, using mixed effects generalized linear models and interrupted time-series analyses. Adoption and implementation will be evaluated through usage statistics, surveys, and qualitative interviews to identify factors influencing success. This study will assess the impact of VA-EQuIP on colonoscopy quality metrics and factors associated with effective implementation. VA-EQuIP infrastructure allows for national-scale implementation and evaluation of quality reporting with minimal manual labor, guiding future quality improvement efforts to ensure optimal patient care.

What does it cost to expand two-way texting for post-operative follow-up? A cost analysis in routine voluntary medical male circumcision settings in South Africa.

Up to 98% of adult voluntary medical male circumcision (VMMC) clients heal without adverse events (AEs) in South Africa and in the sub-Saharan Africa (SSA) region, yet all clients in South Africa (SA) are still required to attend in-person reviews, creating added work for providers and barriers for clients. A randomized controlled trial (RCT) using our fee-free, open-source, two-way texting (2wT) approach showed that males could independently monitor their healing with support from VMMC nurse-led telehealth and that 2wT was more cost-effective than routine visits for quality post-operative monitoring. The objectives of this costing activity were to assess the additive cost of 2wT vs. SoC during a stepped wedge design (SWD) expansion trial; costing an augmentation of 2wT with dedicated personnel during peak VMMC periods; and estimate the cost savings of 2wT from the payer perspective if scaled in routine VMMC settings. Data was collected from routine financial reports and complemented by previous RCT time-motion estimates. We conducted activity-based costing of SWD and peak season periods; sensitivity analysis estimated 2wT costs at scale. We included data from 6,842 males, with 2,586 (38%) opting for 2wT. 2wT participants attended an average of zero visits; SoC males had an average of 2 visits. Under 2wT, quality care markers improved and AE ascertainment increased while loss to follow-up (LTFU) decreased. Given a VMMC population of 10,000 adults, scenario analysis suggests that: 1) 2wT becomes cost neutral with 45% 2wT enrollment; 2) 2wT saves $0.29/client with 60% 2wT enrollment; and 3) 2wT saves $0.46/client with 80% 2wT enrollment. When implemented at scale, 2wT appears to significantly reduce costs to the healthcare system while improving the quality of post-operative care and requiring no additional client costs. 2wT should be expanded for eligible males across VMMC and other post-operative contexts in South Africa.

Implementation of a cardiovascular toolkit in primary care increased women Veterans' engagement in behavior change programs: results from a non-randomized stepped wedge trial.

Cardiovascular (CV) disease is the leading cause of death among U.S. women, yet women have a limited understanding of their CV-related morbidity and mortality risks. Provider-, system-, and patient-level barriers point to a need for multi-level evidence-based strategies to facilitate CV risk reduction. Guided by the Replicating Effective Programs framework and complexity theory, we implemented a CV Toolkit in primary care clinics for women Veterans. The objective was to evaluate the effect of implementation of CV toolkit on participation in behavior change programs that target CV risk reduction. In partnership with the Veterans Health Administration (VA) Office of Women's Health and National Center for Health Promotion and Disease Prevention, we developed and implemented a CV Toolkit at five geographically diverse VA sites between March 2017-March 2020. Using a non-randomized stepped wedge design, we evaluated the effect of the implementation of toolkit on participation in the VA MOVE! weight management program, and on participation in health promotion and disease prevention (HPDP) programs (coaching, facilitated groups, etc.) and/or complementary integrative health (CIH) programs (yoga, meditation, etc.). We utilized a three-level (patient, site, time) non-linear fixed effect model with stratification by age (65 and older versus younger). Patient participation, utilization, and demographics were extracted from VA administrative data for all women with at least one primary care visit at a participating site from December 2016-March 2020 (n = 6009). Women were on average 45 years old; 38% were white, 31% Black, 17% Hispanic; and over a third had CV risk factors and/or mental health diagnoses. For women 65 years and older (n = 540), active toolkit implementation resulted in increased odds of MOVE! participation (OR = 1.09; 95% CI:1.030-1.152) compared to when the toolkit was not active either within or between sites. Women younger than 65 (n = 5469) had increased odds of using HPDP/CIH programs during active toolkit implementation (OR = 1.01; 95% CI:1.002-1.022). Active implementation of the CV Toolkit intervention was significantly associated with increasing participation in behavior change programs. Variation in program participation by age suggests that the diversity of behavior change programs available to women Veterans may facilitate participation across the lifespan. Clinical Trials.gov, NCT02991534. Registered 12-09-2016, https://clinicaltrials.gov/study/NCT02991534?cond=NCT02991534&rank=1.

Care bundles to improve enteral nutrition management in stroke patients: study protocol for a stepped wedge cluster randomised trial

BackgroundEnteral nutrition for stroke patients in China presents major shortcomings. This aspect of care involves multiple components, and poor implementation of any one of them may affect the patients’ enteral nutrition. Most current studies only confirm the effectiveness of the application of single interventions and lack any scientific evaluation of the overall ensemble of enteral nutrition interventions in stroke patients. This study focuses on evaluating the overall effectiveness of a care bundles for the management of enteral nutrition in stroke patients by targeting multiple simultaneous interventions.MethodsThis study is to be conducted over 10 periods in the stroke patient wards of eight hospitals across China. As the trial progresses, each hospital begins by receiving the control group care and then shifts to the intervention group care. The point at which each hospital shifts care is randomised. During this time, the control group implements its usual care, while the intervention group implements an evidence-based care bundles for enteral nutrition management in stroke patients. The primary indicator in this study is feeding intolerance; indicators for the evaluation of nutritional status, gastrointestinal complications, and disease prognosis are also included.DiscussionWe anticipate that the care bundles developed by pooling this evidence will be manifestly more beneficial than harmful and will be worthy of replication. Hence, we chose a stepped wedge cluster randomised trial to validate the application of these interventions. This study will provide experience and reference on how to promote the clinical translation of evidence-based evidence and standardise enteral nutrition care management in stroke patients.Trial registrationChiCTR2300067930. Registered on January 31, 2023.

Levers and challenges to recruiting clinical settings for a shared decision-making stepped wedge cluster randomized trial

Levers and challenges to recruiting clinical settings for a shared decision-making stepped wedge cluster randomized trial

Application of machine learning techniques to profile smoking behavior of adolescent girls in Ghana

Background Tobacco use trends among adolescents in low- and middle-income countries, and in particular narrowing gender gaps, highlight the need for interventions to prevent and/or reduce tobacco use among adolescent girls. We evaluated a social marketing program in Ghana discouraging tobacco use among adolescent girls and additionally investigated the pathways influencing smoking behaviors to identify programmatic opportunities for impact. Leveraging the data collected through the stepped wedge cluster randomized trial and panel survey of 9000 girls aged 13–19 , we sought to apply machine learning (ML) techniques to identify the most important variables for predicting initiation of smoking. Methods To identify predictors of smoking initiation we sought to develop a model which could accurately differentiate smokers from non-smokers and evaluated various ML approaches for training classifier algorithms to achieve this. We selected a Synthetic Minority Over-sampling Technique (SMOTE) because it optimized the recall and precision of the model. We then utilized the technique of feature importance for greater insight into how the model arrived at its decisions and to rank the most important variables for predicting smokers. To explore different dimensions of smoking behavior, including initiation and continuation, we trained our model by using several combinations of target outcomes and input variables from the panel survey. Results The resulting features of smokers highlight the importance of girls’ independence and connectivity, social environment, and peer influence on likelihood of smoking, and in particular subsequent initiation. These results were largely consistent with our formative research findings based on qualitative interviews informed by behavioral science. Conclusions This novel application of ML techniques demonstrates how data science approaches can generate new programmatic insights from rigorous evaluation data, especially when data collection is informed by behavioral theory. Such insights about the relative importance of different features can be valuable input for program planning and outreach.

Review article: Primer for clinical researchers on innovative trial designs for emergency medicine.

Randomised trials have long been recognised as the gold standard research tool for evidence-based medicine. The past decade has seen the emergence of several innovative trial designs that are revolutionising how trials are conducted. These innovative designs enable more efficient, pragmatic trials that can address complex research questions which were previously not possible. In this paper, we provide an overview of the key innovative designs that are likely to be useful in the emergency medicine context, namely cluster crossover and stepped wedge designs, sequential multiple assignment randomised trial (SMART) designs, and platform trials. We describe the main features of each design, outline their pros and cons, and describe when they may or may not be useful. We also provide examples of these innovative designs in contexts that are relevant to emergency medicine.

A stepped wedge randomised controlled trial assessing the efficacy and patient acceptability of virtual clinical pharmacy in rural and remote Australian hospitals

BackgroundDespite medication being the most common healthcare intervention and medication-related incidents being common in hospitals, many rural and remote hospitals in Australia lack onsite pharmacy services due to resource constraints. A Virtual Clinical Pharmacy Service (VCPS) staffed by two senior, rural generalist hospital pharmacists assigned to four hospitals each was implemented in rural and remote facilities to determine whether the VCPS increased adherence to National Safety and Quality Health Service Standards (NSQHS).MethodsA stepped-wedge randomised controlled trial was employed to sequentially implement a telehealth pharmacy service at one-month intervals in eight hospitals. The primary outcomes were patient-level medication reconciliation completion rates on admission and discharge. Secondary measures evaluated compliance with other NSQHS standards (including Best Possible Medication History, Medication Reconciliation and venous thromboembolism risk assessment), patient outcomes (including representation within 48 h, readmission within 28 days and length of stay), and detection of potential medication-related harms (including pharmacist identified medication related problems, reported medication errors and falls). Patients were invited to complete a patient-reported experience questionnaire. Data were collected from electronic medical records and analysed using mixed logistic regression models to estimate the effectiveness of the VCPS. Antimicrobial usage, falls, and medication errors were analysed at the facility level, while other data were analysed at the patient level.ResultsCompared to control (n = 535), patients in the intervention period (n = 527) were more likely to have an admission medication reconciliation completed (Odds Ratio (OR) 11.16, 95% confidence interval (CI) 5.59–22.30, p < 0.001) in models adjusted for the study period. A similar improvement was observed for discharge medication reconciliation completion (OR 4.07, CI 2.38–6.95, p < 0.001), whereas a 33-fold improvement was seen in Best Possible Medication History completion (OR 33.27, CI 17.53–63.14, p < 0.001). The VCPS documented 879 medication related problems, with 61% of patients having at least one medication-related problem documented by a pharmacist. There was no change in length of stay, falls, readmission rates or reported medication error rates; however, the study was not powered to detect these changes. Patient feedback was positive and comparable to in-person care, with 95% (179/189) reporting their overall experience as ‘good’ or ‘very good.’ No unintended harms were reported.ConclusionsThe VCPS improved compliance with national standards for medication safety, had high patient acceptability and resulted in the detection of clinically relevant medication-related issues in rural and remote settings. The applicability of virtual pharmacy should be explored in further rural and remote locations in addition to other settings such as metropolitan locations with no onsite clinical pharmacists.Ethics numberGWHREC 2019/ETH13355.Trial registrationANZCTR registration number ACTRN12619001757101. Registered on 11/12/2019. Published trial protocol: A stepped wedge trial of efficacy and scalability of a virtual clinical pharmacy service (VCPS) in rural and remote NSW health facilities.

Investigation of Mechanical Properties, Shade, and Water Sorption/Solubility of Commercial Composite Resins

Objectives: Assessment of mechanical properties of composite resins is important since they can affect the clinical performance and longevity of restorations. This study aimed to assess and compare different properties of dental composite resins available in the market. Materials and Methods: In this comparative study, samples of four different dental composite resins (Edge COM, Saremco, FGM, and Kulzer) were tested according to ISO 4049:2019 guidelines. Flexural strength (by using a universal testing machine), depth of cure (using the ISO 4049 scrape technique), radiopacity (with aluminum step wedge), water sorption/solubility (by using immersion and drying cycles), and shade (by using Vita Easy Shade) of the samples were assessed. Data were analyzed by one-way ANOVA and Tukey's post-hoc test (alpha=0.05). Results: No significant difference was found in flexural strength among the four groups (P&gt;0.05). The depth of cure of FGM was significantly higher than that of other groups (P&lt;0.05). Solubility and water sorption were the highest in Kulzer, and the lowest in Edge COM (P&lt;0.05). All tested composites met the necessary radiopacity standards for precise radiographic diagnosis; radiopacity was higher in Saremco and FGM groups. None of the composite resins matched the reference A2 shade. Conclusion: Although no significant difference was found in flexural strength of the tested composites, they had differences in other properties. Edge COM exhibited high flexural strength, while Saremco had optimal radiopacity.