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• Most respiratory tract infections (RTI) do not require antibiotics. • In Nigerian private community pharmacies, non-prescription use of antibiotics for RTI is usual. • Such practice could contribute to the spread of antibiotic resistance. • C-reactive protein testing intervention in these pharmacies reduces their antibiotic use for RTI. To ascertain if access to C-reactive protein (CRP) test kits—and staff training on how to use them in respiratory tract infection (RTI) management—in private community pharmacies (PCPs) can reduce non-prescription antibiotic dispensing for RTI. A parallel cluster randomized controlled trial was conducted in Nigeria. The clusters—which were equally the participating units—were PCPs with blood testing experience. Stratified block randomization was done. PCPs were stratified by the baseline value of the primary outcome. PCPs were not blinded. The intervention PCPs were provided with CRP kits and trained to use them to make decisions regarding non-prescription antibiotic dispensing for RTI. The control PCPs received no intervention. The primary outcome was the non-prescription antibiotic dispensing rate for RTI. Data were collected by blinded simulated clients who visited each PCP 30 times before and after the intervention without prescriptions. Analyses were by intention-to-treat. Twenty PCPs were randomized, 1:1. Ten PCPs were analyzed in each arm. Each PCP contributed 30 data points to the multiple imputation analysis where antibiotic dispensing decreased by 15.66% (209/300 [intervention] vs 256/300 [control]) in the adjusted analysis (odds ratio = 0·279, 95% confidence interval = 0.107-0.726; P -value = 0.0090) and 16% (208/300 [intervention] vs 256/300 [control]) in the crude analysis (odds ratio = 0.299, 95% confidence interval = 0.098-0.911; P -value = 0.034). Access to CRP kits—and staff training on how to use them in RTI management—in PCPs reduced non-prescription antibiotic dispensing for RTI. [ABSTRACT FROM AUTHOR]

Prior research demonstrates that nearly all (95 %) people with lung cancer (PwLC) report stigma, and approximately half (48 %) PwLC experience stigma during clinical encounters with oncology care providers (OCPs). When stigma is experienced in a medical context, it can have undesirable consequences including patients' delaying and underreporting of symptoms, misreporting of smoking behavior, and avoiding help-seeking such as psychosocial support and cessation counseling. Multi-level interventions are needed to prevent and mitigate lung cancer stigma. One promising intervention for reducing patient perception and experience of stigma is to train OCPs in responding empathically to patient emotions and promoting empathic communication within clinical encounters. This paper describes the study protocol for a cluster randomized trial comparing Usual Care (waitlist control group) with Empathic Communication Skills (ECS) training (intervention group). For this study, we will recruit 16 community oncology practice sites, 9–11 OCPs per site, and 6 PwLCs per OCP. The goal of this trial is to investigate the effect of the ECS training on (a) OCP primary outcomes (communication and empathic skill uptake) and secondary outcomes (ECS training appraisal – relevance, novelty, clarity; self-efficacy, attitude towards communication with patients); and (b) patient-reported primary outcomes (lung cancer stigma), and secondary outcomes (perceived clinician empathy, satisfaction with OCP communication, psychological distress, social isolation, and appraisal of care). Findings from this trial will advance understanding of the effectiveness of the ECS training intervention and inform future provider-level training interventions that may reduce lung cancer stigma and improve cancer care delivery. ClinicalTrials.gov Identifier : NCT05456841 [ABSTRACT FROM AUTHOR]

Cardiopulmonary resuscitation training is a mandatory competency, especially for healthcare professionals. However, the spread of COVID-19 caused a sharp decline in the number of participants on advanced life support training, thereby accelerating the diversification of educational methods. Gamification is an increasingly popular method of diversifying instruction, but its effectiveness remains controversial. To evaluate the effectiveness of gamification learning in advanced life support training. A cluster randomized controlled trial. A single advanced life support training center. Clinical nurses who are currently practicing in a hospital. A part of the existing advanced life support course was gamified using Kahoot! platform. Conventional learning and gamified learning were each conducted 11 times, and the level of knowledge after training was assessed. The assessment questions were categorized into advanced life support algorithms, teamwork, and cardiac arrest rhythms. A total of 267 were enrolled in the study, and 148 and 139 learners were assigned to CL and GL, respectively. There was no difference in post-training knowledge related to teamwork, and cardiac arrest rhythms between the conventional learning and gamified learning groups, but knowledge related to the advanced life support algorithm was low in the gamified learning group. Even if the learners are the same, advanced life support gamification training can lead to negative outcomes depending on the simplicity or goal of the training content. To improve the effectiveness of the training, various methods of gamification training should be applied depending on the goal and content of the training. • COVID-19 prompted a decline in ALS training, accelerating innovative methods. • Despite popularity, gamification's effectiveness in ALS training remains debated. • Conducted at an ALS center, evaluating gamified vs. conventional learning. • Tailored gamification methods are crucial for effective training. [ABSTRACT FROM AUTHOR]

In people with knee osteoarthritis, how much more effective is stratified exercise therapy that distinguishes three subgroups (high muscle strength subgroup, low muscle strength subgroup, obesity subgroup) in reducing knee pain and improving physical function than usual exercise therapy? Pragmatic cluster randomised controlled trial in a primary care setting. A total of 335 people with knee osteoarthritis: 153 in an experimental arm and 182 in a control arm. Physiotherapy practices were randomised into an experimental arm providing stratified exercise therapy (supplemented by a dietary intervention from a dietician for the obesity subgroup) or a control arm providing usual, non-stratified exercise therapy. Primary outcomes were knee pain severity (numerical rating scale for pain, 0 to 10) and physical function (Knee Injury and Osteoarthritis Outcome Score subscale activities of daily living, 0 to 100). Measurements were performed at baseline, 3 months (primary endpoint) and 6 and 12 months (follow-up). Intention-to-treat, multilevel, regression analysis was performed. Negligible differences were found between the experimental and control groups in knee pain (mean adjusted difference 0.2, 95% CI –0.4 to 0.7) and physical function (–0.8, 95% CI –4.3 to 2.6) at 3 months. Similar effects between groups were also found for each subgroup separately, as well as at other time points and for nearly all secondary outcome measures. This pragmatic trial demonstrated no added value regarding clinical outcomes of the model of stratified exercise therapy compared with usual exercise therapy. This could be attributed to the experimental arm therapists facing difficulty in effectively applying the model (especially in the obesity subgroup) and to elements of stratified exercise therapy possibly being applied in the control arm. Netherlands National Trial Register NL7463. [ABSTRACT FROM AUTHOR]

Background: Soutenir l'Exploitation Familiale pour Lancer l'Élevage des Volailles et Valoriser l'Économie Rurale (SELEVER) is a nutrition- and gender-sensitive poultry value chain project designed and implemented by international nongovernmental organization Tanager, which consists of poultry market facilitation and behavior change activities aiming at increasing poultry production and improving diets without free inputs transfer.Objectives: The study aimed at assessing the impact of SELEVER on diets of women and children during the lean season.Methods: Within a cluster randomized controlled trial, 45 communes were assigned to 1 of 3 arms, including 1) SELEVER interventions, 2) SELEVER with an intensive hygiene and sanitation component (SELEVER + WASH), and 3) a control group without intervention. Two rounds of survey were conducted 2 y apart during the lean season. Primary dietary outcomes were the probability of adequacy (PA) of iron, zinc, and vitamin A intakes; mean PA of 11 micronutrients and individual dietary diversity score collected through quantitative 24-h recall in longitudinal samples of women and index children (2-4 y old) in 1054 households; and minimum acceptable diet in the repeated cross-sectional sample of their younger sibling aged 6-23 mo. Impacts were assessed by intention-to-treat ANCOVA.Results: Relative to control, SELEVER interventions (groups 1 + 2) increased the PA of iron intakes in women by 1.8 percentage points (pp) (P = 0.030). We found no further impact on primary outcomes, although egg consumption increased in index children (+0.73 pp, P = 0.010; +0.69 kcal/d, P = 0.036). Across the 3 groups, we observed negative effects of SELEVER on the PA of zinc intakes in women relative to SELEVER + WASH (-4.1 pp, P = 0.038) and on a variety of secondary dietary outcomes relative to both other groups. The study was registered on the ISCRCTN registry (ISRCTN16686478).Conclusions: Information-only-based value chain interventions may not have meaningful positive effects on diets of women and children in the lean season in settings with largely inadequate diets. We found suggestive evidence that synergies between intervention components may have introduced heterogeneity in effects on diet. [ABSTRACT FROM AUTHOR]

Objectives: To reduce all-cause maternal and perinatal mortality and major morbidity through Lady Health Worker (LHW)-facilitated community engagement and early diagnosis, stabilization and referral of women with preeclampsia, an important contributor to adverse maternal and perinatal outcomes given delays in early detection and initial management.Study Design: In the Pakistan Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial (NCT01911494), LHWs engaged the community, recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization.Main Outcome Measures: The primary outcome was a composite of maternal, fetal and newborn mortality and major morbidity.Findings: We recruited 39,446 women in intervention (N = 20,264) and control clusters (N = 19,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively). The primary outcome did not differ between intervention (26·6%) and control (21·9%) clusters (adjusted odds ratio, aOR, 1∙20 [95% confidence interval 0∙84-1∙72]; p = 0∙31). There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77); early (0·95 [0·82-1·09]; p = 0·46) or late neonatal deaths (1·23 [0·97-1·55]; p = 0·09); or neonatal morbidity (1·22 [0·77, 1·96]; p = 0·40). Improvements in outcome rates were observed with 4-7 (p = 0·015) and ≥8 (p < 0·001) (vs. 0) CLIP contacts.Interpretation: The CLIP intervention was well accepted by the community and implemented by LHWs. Lack of effects on adverse outcomes could relate to quality care for mothers with pre-eclampsia in health facilities. Future strategies for community outreach must also be accompanied by health facility strengthening.Funding: The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337). [ABSTRACT FROM AUTHOR]

Objectives: Pregnancy hypertension is associated with 7.1% of maternal deaths in India. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.Study Design: The Indian Community-Level Interventions for Pre-eclampsia (CLIP) open-label cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka. The CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4 h) or non-urgently (<24 h), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of mHealth-guided CHW-provided contacts.Main Outcome Measures: 20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.Results: All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up. The primary outcome did not differ between intervention and control arms (adjusted odds ratio (aOR) 0.92 [95% confidence interval 0.74, 1.15]; p = 0.47; intraclass correlation coefficient 0.013). There were no intervention-related safety concerns following administration of either methyldopa or MgSO4, and 401 facility referrals. Compared with intervention arm women without CLIP contacts, those with ≥8 contacts suffered fewer stillbirths (aOR 0.19 [0.10, 0.35]; p < 0.001), at the probable expense of survivable neonatal morbidity (aOR 1.39 [0.97, 1.99]; p = 0.072).Conclusions: As implemented, solely community-level interventions focussed on pre-eclampsia did not improve outcomes in northwest Karnataka. [ABSTRACT FROM AUTHOR]

Objectives: Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.Study Design: The Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently (<24hrs), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of CLIP contacts.Main Outcome Measures: 20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.Results: 15,013 women (15,123 pregnancies) were recruited in intervention (N = 7930; 2·0% loss to follow-up (LTFU)) and control (N = 7190; 2·8% LTFU) clusters. The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40). Compared with intervention arm women without CLIP contacts, those with ≥8 contacts experienced fewer primary outcomes (aOR 0·79 (95% CI 0·63, 0·99); p = 0·041), primarily due to improved maternal outcomes (aOR 0·72 (95% CI 0·53, 0·97); p = 0·033).Interpretation: As generally implemented, the CLIP intervention did not improve pregnancy outcomes; community implementation of the WHO eight contact model may be beneficial.Funding: The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337). [ABSTRACT FROM AUTHOR]

Background: Young children in Malawi consume low-quality diets lacking micronutrients critical for their development.Objective: To evaluate the impact of an agriculture and nutrition behavior change communication (BCC) intervention implemented through community-based childcare centers on the nutrient adequacy of diets of children living in food-insecure settings in Malawi.Methods: A cluster randomized trial was undertaken in 60 community-based childcare centers, including 1248 children aged 3-6 y. Nutrient intakes were estimated using interactive, multipass 24-h recall. Dietary adequacy was estimated through the probability of adequacy (PA) and mean probability of adequacy (MPA) of 11 micronutrients. Impacts were assessed by difference-in-difference (DID) estimates, adjusted for geographic clustering and child age and sex.Results: Intervention groups were similar for most baseline characteristics. Loss to follow-up was low (7% over a 12-mo period) and participation in the intervention was high (>90% enrollment and 80% attendance during the 5 d before the survey). Positive impacts were found for the PA of several individual micronutrient intakes: vitamin A [DID: 9 percentage points (pp), SE 3 pp], vitamin C (14 pp, SE 3 pp), riboflavin (11 pp, SE 3 pp), zinc (8 pp, SE 3 pp), and for the MPA for the 11 nutrients considered (5 pp, SE 1 pp). These impacts were driven by effects on younger children (aged 3-4 y).Conclusions: Using a preschool platform to implement a nutrition-sensitive BCC intervention is an effective strategy to improve the adequacy of micronutrient intake of preschool children in food-insecure settings. The trial was registered at ISCRCTN as ISCRCTN96497560. [ABSTRACT FROM AUTHOR]

Despite clear evidence for the lack of effectiveness and safety, physical restraints are frequently applied in nursing homes. Multicomponent interventions addressing nurses' attitudes and organizational culture have been effective in reducing physical restraints. To evaluate the effectiveness of two versions of a guideline and theory-based multicomponent intervention to reduce physical restraints in nursing homes. Pragmatic cluster randomized controlled trial. The study was conducted in 120 nursing homes in four regions in Germany. All residents living in the participating nursing home during follow-up, newly admitted residents were also included. A total of 12,245 residents included in the primary analysis (4126 and 3547 residents in intervention group 1 and 2 and 4572 residents in the control group). Intervention group 1 received an updated version of a successfully tested guideline-based multicomponent intervention (comprising brief education for the nursing staff, intensive training of nominated key nurses in each cluster, introduction of a least-restraint policy and supportive material), intervention group 2 received a concise version of the original program and the control group received optimized usual care (i.e. supportive materials only). Primary outcome was physical restraint prevalence at twelve months, assessed through direct observation by blinded investigators. Intervention and control groups were compared using baseline-adjusted linear regression on cluster level, Bonferroni-adjusted for double testing. Secondary outcomes included falls, fall-related fractures, and quality of life. We also described intervention costs and performed a comprehensive process analysis. At baseline, mean physical restraint prevalence was 17.4% and 19.6% in intervention groups 1 and 2, and 18.8% in the control group. After twelve months, mean prevalence was 14.6%, 15.7%, and 17.6%. Baseline-adjusted differences between mean prevalences were 2.0% (97.5% CI, -5.8 to 1.9) lower in intervention group 1 and 2.5% (97.5% CI, -6.4 to 1.4) lower in intervention group 2 compared to controls. Physical restraint prevalence showed a pronounced variation between the different clusters in all study groups. We found no significant differences in the secondary outcomes. According to the process evaluation, the intervention was mainly implemented as planned, but the expected change towards a least restraint culture of care was not achieved in all clusters. Neither intervention showed a clear advantage compared to control. The pronounced center variation in physical restraint prevalence indicates that other approaches like governmental policies are needed to sustainably change physical restraint practice and reduce center variations in nursing homes. ClinicalTrials.gov : NCT02341898. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effectiveness of a universal parent-oriented alcohol prevention program ("Effekt") in Estonia. The main objective of the program was to delay and reduce adolescents' alcohol consumption by maintaining parental restrictive attitudes towards adolescents' alcohol use over time.Methods: A matched-pair cluster randomized controlled trial with a three-year assessment period (baseline (T1), 18-months (T2) and 30-months (T3) follow-ups) was undertaken in 2012-2015 among 985 fifth grade adolescents and 790 parents in sixty-six schools (34 intervention, 32 control). The primary outcome measure was adolescents' alcohol use initiation. Secondary outcome measures were lifetime drunkenness and alcohol use in the past year. Intermediate outcomes were restrictive parental attitudes towards adolescents' alcohol use reported by parents and perceived restrictive parental attitudes and parental alcohol supply reported by adolescents.Results: There were no significant differences in adolescents' alcohol use initiation, lifetime drunkenness, alcohol use in the past year, parental alcohol supply, and adolescent's perception of parental restrictive attitudes between intervention and control school participants at T2 and T3. There were significant differences in parental attitudes - the odds of having restrictive attitudes were 2.05 (95% confidence interval (CI) = 1.32-3.17) times higher at T2 and 1.92 (95% CI = 1.31-2.83) times higher at T3 in the intervention group than in the control group.Conclusions: The Estonian version of the "Effekt" program had a positive effect on parental attitudes, but it did not succeed in delaying or reducing adolescents' alcohol consumption. [ABSTRACT FROM AUTHOR]

Abstract Introduction Approximately 5–8% of children report severe chronic pain and disability. Although evidence supports pain-self management as effective for reducing pain and disability, most youth do not have access to psychological intervention. Our prior studies demonstrate that an existing internet-delivered pain self-management program (WebMAP) can reduce barriers to care, is feasible, acceptable, and is effective in reducing pain-related disability in youth with chronic pain. The current trial seeks to: 1) determine the effectiveness of a mobile app version of WebMAP for improving patient pain-related outcomes, and 2) evaluate a novel implementation strategy to maximize the public health impact of the intervention including the determination of adoption, reach, and sustainability of WebMAP in specialty clinics serving children with chronic pain in the United States. Methods This hybrid effectiveness-implementation cluster randomized controlled trial employs a stepped wedge design in which the WebMAP mobile intervention is sequentially implemented in 8 specialty pain clinics following a usual care period. This trial aims to enroll a minimum of 120 youth (ages 10–17) who have chronic pain. Outcome analyses will determine effectiveness of treatment on adolescent pain-related outcomes as well as public health impact via reach, adoption, implementation, and maintenance. Conclusions This trial examines an innovative approach to evaluate a technology-delivered pain self-management program for youth with chronic pain. Findings are expected to yield a strategic approach for delivering a digital pain management program for youth with chronic pain that can be sustained in clinical settings. Clinical Trial Registration #: NCT03332563 [ABSTRACT FROM AUTHOR]

Background: Adherence to guidelines for patients with proximal femur fracture is suboptimal.Objective: To evaluate the effect of a care pathway for the in-hospital management of older geriatric hip fracture patients on adherence to guidelines and patient outcomes.Design: The European Quality of Care Pathways study is a cluster randomized controlled trial.Setting: 26 hospitals in Belgium, Italy and Portugal.Subjects: Older adults with a proximal femur fracture (n = 514 patients) were included.Methods: Hospitals treating older adults (>65) with a proximal femur fracture were randomly assigned to an intervention group, i.e. implementation of a care pathway, or control group, i.e. usual care. Thirteen patient outcomes and 24 process indicators regarding in-hospital management, as well as three not-recommended care activities were measured. Adjusted and unadjusted regression analyses were conducted using intention-to-treat procedures.Results: In the intervention group 301 patients in 15 hospitals were included, and in the control group 213 patients in 11 hospitals. Sixty-five percent of the patients were older than 80 years. The implementation of this care pathway had no significant impact on the thirteen patient outcomes. The preoperative management improved significantly. Eighteen of 24 process indicators improved, but only two improved significantly. Only for a few teams a geriatrician was an integral member of the treatment team.Discussion: Implementation of a care pathway improved compliance to evidence, but no significant effect on patient outcomes was found. The impact of the collaboration between surgeons and geriatricians on adherence to guidelines and patient outcomes should be studied.Trial Registration: ClinicalTrials.gov: NCT00962910. [ABSTRACT FROM AUTHOR]

Objective: Improving adherence is a challenge and multiple barriers are likely to explain non-adherence. These barriers differ per patient and over course of the regimen. Hence, personalized interventions tailored to the specific barriers are needed. In a theoretical and evidence-based Tailored Multimedia Intervention, technology (online preparatory assessment, text messaging) was used as an add-on to a tailored counseling session (learned during a communication skills training), with the expectation of synergistic effects.Methods: A cluster randomized controlled trial was conducted in six hospitals, eight nurses and 160 chronic patients. Patient satisfaction with communication, beliefs about medication, self-efficacy and medication adherence were assessed at initiation of the treatment and after six months.Results: Intervention effects were found for patient satisfaction with nurses' affective communication and self-efficacy at the initiation of treatment. The effect on self-efficacy remained after six months.Conclusion: By combining tailored counseling with technology, this intervention resulted in positive changes in important prerequisites of medication adherence.Practical Implications: Technology can contribute significantly to health care providers' ability to tailor information to the patients' needs. [ABSTRACT FROM AUTHOR]

• A multi-faceted computerized antimicrobial stewardship programme (ASP), including a guideline-based decision-support tool, weekly performance reporting tool and real-time feedback repository, was integrated with the physician order entry systems. • In this randomized clinical trial that included 2470 patients, the multi-faceted computerized ASP significantly reduced antimicrobial use by 14.2%, measured by days of therapy/1000 patient-days without raising safety issues. • In surgical settings, clinical application of the multi-faceted computerized ASP would be an effective, safe and efficient practice in the management of antimicrobial use. Inappropriate antimicrobial use is common among patients undergoing surgery. It remains unclear whether a multi-faceted computerized antimicrobial stewardship programme is effective and safe in reducing inappropriate antimicrobial use in surgical settings. A multi-faceted computerized antimicrobial stewardship intervention system was developed, and an open-label, cluster-randomized, controlled trial was conducted among 18 surgical teams that enrolled 2470 patients for open chest cardiovascular surgery. The surgical teams were divided at random into intervention and control groups at a ratio of 1:1. The primary endpoints were days of therapy (DOT)/1000 patient-days, defined daily dose (DDD)/1000 patient-days and length of therapy (LOT)/1000 patient-days. Mean DOT, DDD and LOT per 1000 patient-days were significantly lower in the intervention group compared with the control group (472.2 vs 539.8, 459.5 vs 553.8, and 438.4 vs 488.7; P <0.05), with reductions of 14.2% [95% confidence interval (CI) 11.8–16.7%], 18.7% (95% CI 15.9–21.4%) and 11.9% (95% CI 9.6–14.1%), respectively. The daily risk of inappropriate antimicrobial use after discharge from the intensive care unit decreased by 23.9% [95% CI 15.5–31.5% (incidence risk ratio 0.76, 95% CI 0.69–0.85)] in the intervention group. There was no significant difference in rates of infection or surgical-related complications between the groups. Median antimicrobial costs were significantly lower in the intervention group {873.4 [interquartile range (IQR) 684.5–1255.4] RMB vs 1178.7 (IQR 869.1–1814.5) RMB; P <0.001} (1 RMB approximately equivalent to 0.16 US$ in 2022). The multi-faceted computerized antimicrobial stewardship interventions reduced inappropriate antimicrobial use safely. Clinicaltrials.gov: NCT04328090. [ABSTRACT FROM AUTHOR]

• Current evidence showed that exercise therapy is a cost-effective treatment in knee OA. • Our stratified approach of exercise therapy did not appear to be cost-effective compared to usual exercise therapy. • Policy-makers should decide whether stratified exercise therapy can be implemented. A stratified approach to exercise therapy may yield superior clinical and economic outcomes, given the large heterogeneity of individuals with knee osteoarthritis (OA). To evaluate the cost-effectiveness during a 12-month follow-up of a model of stratified exercise therapy compared to usual exercise therapy in patients with knee OA, from a societal and healthcare perspective. An economic evaluation was conducted alongside a cluster-randomized controlled trial in patients with knee OA (n = 335), comparing subgroup-specific exercise therapy for a 'high muscle strength subgroup', 'low muscle strength subgroup', and 'obesity subgroup' supplemented by a dietary intervention for the 'obesity subgroup' (experimental group), with usual ('non-stratified') exercise therapy (control group). Clinical outcomes included quality-adjusted life years – QALYs (EuroQol-5D-5 L), knee pain (Numerical Rating Scale) and physical functioning (Knee Injury and Osteoarthritis Outcome Score in daily living). Costs were measured by self-reported questionnaires at 3, 6, 9 and 12-month follow-up. Missing data were imputed using multiple imputation. Data were analyzed through linear regression. Bootstrapping techniques were applied to estimate statistical uncertainty. During 12-month follow-up, there were no significant between-group differences in clinical outcomes. The total societal costs of the experimental group were on average lower compared to the control group (mean [95% confidence interval]: € 405 [-1728, 918]), albeit with a high level of uncertainty. We found a negligible difference in QALYs between groups (mean [95% confidence interval]: 0.006 [-0.011, 0.023]). The probability of stratified exercise therapy being cost-effective compared to usual exercise therapy from the societal perspective was around 73%, regardless of the willingness-to-pay threshold. However, this probability decreased substantially to 50% (willingness-to-pay threshold of €20.000/QALY) when using the healthcare perspective. Similar results were found for knee pain and physical functioning. We found no clear evidence that stratified exercise therapy is likely to be cost-effective compared to usual exercise therapy in patients with knee OA. However, results should be interpreted with caution as the study power was lower than intended, due to the Coronavirus disease (COVID-19) pandemic. [ABSTRACT FROM AUTHOR]

Introduction In 2014, Fire & Rescue New South Wales piloted the delivery of its home fire safety checks program (HFSC) aimed at engaging and educating targeted top “at risk” groups to prevent and prepare for fire. This pilot study aimed to assess the effectiveness of smoke alarms using a cluster randomized controlled trial. Methods Survey questionnaires were distributed to the households that had participated in the HFSC program (intervention group). A separate survey questionnaire was distributed to the control group that was identified with similar characteristics to the intervention group in the same suburb. To adjust for potential clustering effects, generalized estimation equations with a log link were used. Results Multivariable analyses revealed that battery and hardwired smoking alarm usage increased by 9% and 3% respectively among the intervention group compared to the control group. Females were more likely to install battery smoke alarms than males. Respondents who possessed a certificate or diploma (AOR = 1.31, 95% CI 1.00–1.70, P = 0.047) and those who were educated up to years 8–12 (AOR = 1.32, 95% CI 1.06–1.64, P = 0.012) were significantly more likely to install battery smoke alarms than those who completed bachelor degrees. Conversely, holders of a certificate or diploma and people who were educated up to years 8–12 were 31% (AOR = 0.69, 95% CI 0.52–0.93, P = 0.014) and 24% (AOR = 0.76, 95% CI 0.60–0.95, P = 0.015) significantly less likely to install a hardwired smoke alarm compared to those who completed bachelor degrees. Conclusions This pilot study provided evidence of the benefit of the HFSC in New South Wales. Practical Applications: Fire safety intervention programs, like HFSC, need to be targeted to male adults with lower level of schooling even when they are aware of their risks. [ABSTRACT FROM AUTHOR]

Objective Assess effects of pharmacists’ counseling by telephone on patients’ satisfaction with counseling, satisfaction with information and beliefs about medicines for newly prescribed medicines. Methods A cluster randomized trial in Dutch community pharmacies. Patients ≥18 years were included when starting with antidepressants, bisphosphonates, RAS-inhibitors or statins. The intervention comprised counseling by telephone to address barriers to adherent behavior. It was supported by an interview protocol. Controls received usual care. Outcomes were effects on beliefs about medication, satisfaction with information and counseling. Data was collected with a questionnaire. Results Responses of 211 patients in nine pharmacies were analyzed. More intervention arm patients were satisfied with counseling (adj. OR 2.2 (95% CI 1.3, 3.6)). Patients with counseling were significantly more satisfied with information on 4 items, had less concerns and less frequently had a ‘skeptical’ attitude towards medication (adj. OR 0.5 (0.3–0.9)). Effects on most outcomes were more pronounced in men than in women. Conclusions Telephone counseling by pharmacists improved satisfaction with counseling and satisfaction with information on some items. It had a small effect on beliefs about medicines. Practice implications Pharmacists can use counseling by telephone, but more research is needed to find out which patients benefit most. [ABSTRACT FROM AUTHOR]

Background Recent evidence demonstrates that children are not engaging in the recommended 60 min of moderate to vigorous physical activity per day. Physical activity (PA) interventions have been acknowledged by the WHO (2010) as a key strategy to increase the PA levels of children. School has been recognised as a primary location for reaching the majority of children and providing PA opportunities for them. However, the sedentary nature of lessons carried out in the classroom has been identified as a contributing factor to physical inactivity among this age group. Purpose The aim of this study is to develop and evaluate a classroom-based intervention which integrates PA and academic content, and evaluate its effects on the PA levels of children aged 8–11 in Ireland. Methods Active Classrooms is an 8-week classroom based intervention guided by the behaviour change wheel (BCW) framework (Michie et al. 2011) that will be evaluated using a cluster randomised controlled trial (RCT). Study measures will be taken at baseline, during the final week of the intervention and at follow-up after 4 months. The primary outcome is minutes of moderate-to-vigorous intensity physical activity during school time objectively assessed using accelerometers (Actigraph). Teachers' perceptions on the effectiveness and use of the intervention and students' enjoyment of the programme will be evaluated post intervention. Conclusions Changing teacher behaviour towards using physically active teaching methods may increase the moderate to vigorous physical activity levels of their students. Therefore, the results of this study may have important implications for the health of children both now and into the future. Trial Registration: ISRCTN14265493 [ABSTRACT FROM AUTHOR]

Abstract: Background: Cardiovascular disease (CVD) is a leading cause of hospitalizations, death, and health care costs. Although studies have shown that modifying CVD risk factors at the patient level improves patient prognosis, the effect of community-wide interventions at the population level has been uncertain. Objective: To evaluate the resource use and cost consequences of a community-wide Cardiovascular Health Awareness Program (CHAP). Methods: Thirty-nine medium-sized communities in Ontario, Canada, participated in a community cluster randomized controlled trial stratified by population size and geographic location. All community-dwelling elderly residents (>65 years) in each community were included. Family physicians, pharmacists, community nurses, local organizations, and volunteers in the intervention communities implemented the program. Rates and costs of CVD hospitalizations, all hospitalizations, emergency department visits, physician visits, and prescription medication use in the year before and after the intervention were compared for the 19 control and 20 CHAP communities by using province-wide linked administrative databases. The cost of implementing and administrating CHAP in each community was combined with total community health care cost to determine the net cost effect. Results: CHAP was associated with a reduction in CVD hospitalization costs. There were no differences in utilization rates or costs for overall hospitalizations, in visits to emergency rooms, physicians, or specialists, or in the use of prescription medications. Results were robust over a range of cost assumptions. Conclusions: A community-wide CVD awareness program can be implemented and can reduce CVD-related hospitalization costs at the level of the community without a corresponding increase in overall health care costs. [Copyright &y& Elsevier]

Summary: With the rapid development of the Internet, online testing is becoming more widely-used in education. The purpose of this study is to explore the learning effectiveness of nursing students using online testing as an assistant tool. The participants were 146 junior college nursing students aged 19 to 20 taking the community health nursing course. With a class as the unit, three classes were randomized and allocated to one experimental group and two control groups. Two structured questionnaires were used to obtain the basic data, and the groups'' examination results were also collected. The results of this study showed that before the intervention, there were no significant differences between the experimental and two control groups. After the intervention and adjusting for potential confounders, the score of midterm test in the experimental group was significantly better than those of the control groups. Over half of the students felt that answering 21 to 30 questions in 31 to 60min for one unit of testing were appropriate. The results of this study showed that online testing is feasible for use as an assistant tool for learning. However, the positive effects of this approach appeared to be short- rather than long-term, and thus more studies are required in future. [Copyright &y& Elsevier]

Abstract: Objective: To describe the application of the stepped wedge cluster randomized controlled trial (CRCT) design. Study Design and Setting: Systematic review. We searched Medline, Embase, PsycINFO, HMIC, CINAHL, Cochrane Library, Web of Knowledge, and Current Controlled Trials Register for articles published up to January 2010. Stepped wedge CRCTs from all fields of research were included. Two authors independently reviewed and extracted data from the studies. Results: Twenty-five studies were included in the review. Motivations for using the design included ethical, logistical, financial, social, and political acceptability and methodological reasons. Most studies were evaluating an intervention during routine implementation. For most of the included studies, there was also a belief or empirical evidence suggesting that the intervention would do more good than harm. There was variation in data analysis methods and insufficient quality of reporting. Conclusions: The stepped wedge CRCT design has been mainly used for evaluating interventions during routine implementation, particularly for interventions that have been shown to be effective in more controlled research settings, or where there is lack of evidence of effectiveness but there is a strong belief that they will do more good than harm. There is need for consistent data analysis and reporting. [Copyright &y& Elsevier]

Abstract: Aim: To evaluate the effectiveness of a school-based substance abuse prevention program developed in the EU-Dap study (EUropean Drug Addiction Prevention trial). Materials and methods: Cluster Randomized Controlled Trial. Seven European countries participated in the study; 170 schools (7079 pupils 12–14 years of age) were randomly assigned to one of three experimental conditions or to a control condition during the school year 2004/2005. The program consisted of a 12-h curriculum based on a comprehensive social influence approach. A pre-test survey assessing past and current substance use was conducted before the implementation of the program, while a post-test survey was carried out about 18 months after the pre-test. The association between program condition and change in substance use at post-test was expressed as adjusted prevalence odds ratio (POR), estimated by multilevel regression models. Results: Persisting beneficial program effects were found for episodes of drunkenness (any, POR=0.80; 0.67–0.97; frequent, POR=0.62; 0.47–0.81) and for frequent cannabis use in the past 30 days (POR=0.74; 0.53–1.00), whereas daily cigarette smoking was not affected by the program as it was at the short-term follow-up. Baseline non-smokers that participated in the program progressed in tobacco consumption to a lower extent than those in the control condition, but no difference was detected in the proportion of quitters or reducers among baseline daily smokers. Conclusion: The experimental evaluation of an innovative school curriculum based on a comprehensive social influence approach, indicated persistent positive effects over 18 months for alcohol abuse and for cannabis use, but not for cigarette smoking. [Copyright &y& Elsevier]

• We conducted a cluster randomized controlled trial (RCT) to examine impact of extension services and Development Agents on adoption of new variety. • Improved extension services result in higher propensity to adopt the new improved variety. • Improved capacity of Development Agents exerts a positive and statistically significant impact on adoption of the new improved variety. • Wealthier households benefit from improved capacity of Development Agents and extension services. Although many studies have shown that sub-Saharan African countries could increase agricultural productivity and output through better technologies and improved crop varieties, the adoption of yield-enhancing technologies by smallholder farmers in the region still remains very low. In this paper, we use a cluster randomized controlled trial to examine whether improved extension services influence smallholder farmers' decisions to try a newly introduced improved wheat variety in Ethiopia. The experiment involved demonstration trials and field days, and improved capacity of Development Agents in facilitation and communication skills. The empirical results revealed that farmers' decisions to try the newly introduced wheat variety were highest in the villages where demonstration trials and field days, and improvements in the Development Agents' facilitation and communication capacity were introduced simultaneously. We also found a positive effect of improved extension services on yields, and the use of chemical fertilizer, herbicides and pesticides, but only the use of herbicides and pesticides were statistically significant. Our findings provide some insights into the significance of revisiting the curriculums of the Technical and Vocational Education and Training, and Farmers' Training Centers. [ABSTRACT FROM AUTHOR]

There is an identified need to improve the evidence-base in relation to contact visits for children in the out-of-home-care (OOHC) system, to ensure optimal outcomes. The aim of this cluster randomized controlled trial (RCT) was to test the effectiveness of a contact intervention for parents having supervised contact with children in long-term OOHC. 183 study children in 15 clusters (OOHC services) and their parent(s) were randomized to the intervention (8 clusters, 100 children) and control groups (7 clusters, 83 children) in three Australian jurisdictions. The manualized intervention consisted of increasing the preparation and support provided by caseworkers to parents before and after their contact visits. Interviews were conducted with carers, parents and caseworkers of the study children at baseline and nine months post-randomization. Interviews included standardized assessment tools measuring child and adult wellbeing and relationships, carer and caseworker ability to support contact, and contact visit cancellations by the parent. Compared with controls, the intention-to-treat (ITT) analyses showed that fewer visits were cancelled by parents in the intervention group at follow-up (−10.27; 95 % CI: −17.04 to −3.50, p =.006). In addition, per-protocol (PP) analyses showed higher caseworker receptivity to contact (6.03; 95 % CI: 0.04–12.03, p =.04), and higher parent satisfaction with contact (7.41; 95 % CI: 0.70–14.11, p =.03) in the intervention group at follow-up. While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits. The findings of the current study provide an important contribution to knowledge in an area where few RCTs have been completed, notwithstanding the null findings. [ABSTRACT FROM AUTHOR]

To investigate the effects of two school-based physical activity interventions on mental health in Norwegian adolescents. Students from 29 lower secondary schools in Norway (n = 2084; 14–15 years; 49% female) were cluster-randomized into either a control group or one of two intervention groups (M1 and M2). Two interventions based on different theoretical frameworks aimed to increase physical activity in school by approximately 120 min per week, throughout a 29-week intervention period. M1 consisted of 30 min physically active learning, 30 min physical activity and one 60 min physical education lesson. M2 consisted of one physical education lesson and one physical activity lesson, both focusing on facilitating students' interest, responsibility and social relationships. The self-report version of the Strengths and Difficulties Questionnaire was used to assess mental health. Physical activity was measured by accelerometry. Linear mixed effects models were used to examine the effects of the interventions. No effects were found for the overall study population. Interaction effects warranted subgroup analyses: M1 showed favorable results in the subgroup with the highest levels of psychological difficulties at baseline (b = −2.9; −5.73 to −0.07; p =.045) and in the immigrant subgroup (b = −1.6; −3.53 to 0.27; p =.093). M2 showed favorable results in the immigrant subgroup (b = −2.1; −4.36 to 0.21; p =.075). The two interventions did not improve mental health in the full study population. However, results indicated beneficial effects among immigrants and those with poor mental health at baseline. More research is needed due to missing values and the results should therefore be interpreted with caution. • Effect of school-based physical activity interventions on mental health. • Cluster-RCT design with 1391 Norwegian 14-15-year-olds. • Results were not compatible with an effect for the overall study population. • Two subgroups showed beneficial effects: those with the poorest mental health at baseline and immigrants. • The results are uncertain, and more research is needed to refute or support them. [ABSTRACT FROM AUTHOR]

To assess the application of a structured process to consolidate the number of medication administration times for residents of aged care facilities. A nonblinded, matched-pair, cluster randomized controlled trial. Permanent residents who were English-speaking and taking at least 1 regular medication, recruited from 8 South Australian residential aged care facilities (RACFs). The intervention involved a clinical pharmacist applying a validated 5-step tool to identify opportunities to reduce medication complexity (eg, by administering medications at the same time or through use of longer-acting or combination formulations). Residents in the comparison group received routine care. The primary outcome at 4-month follow-up was the number of administration times per day for medications charted regularly. Resident satisfaction and quality of life were secondary outcomes. Harms included falls, medication incidents, hospitalizations, and mortality. The association between the intervention and primary outcome was estimated using linear mixed models. Overall, 99 residents participated in the intervention arm and 143 in the comparison arm. At baseline, the mean resident age was 86 years, 74% were female, and medications were taken an average of 4 times daily. Medication simplification was possible for 62 (65%) residents in the intervention arm, with 57 (62%) of 92 simplification recommendations implemented at follow-up. The mean number of administration times at follow-up was reduced in the intervention arm in comparison to usual care (−0.36, 95% confidence interval −0.63 to −0.09, P =.01). No significant changes in secondary outcomes or harms were observed. One-off application of a structured tool to reduce regimen complexity is a low-risk intervention to reduce the burden of medication administration in RACFs and may enable staff to shift time to other resident care activities. [ABSTRACT FROM AUTHOR]

Foundational elements of lifelong health are formed during the preschool years. Child care attendance has nearly doubled in the past 5 years making child care centers an ideal setting to establish healthy habits that prevent pediatric obesity. Despite the promising evidence of efficacy of child care-based obesity prevention interventions, limited attention has been directed to criteria needed for implementation at scale. There is potential to improve children's dietary and physical activity behaviors in diverse communities through theory-based, culturally appropriate, manualized interventions, delivered by child care staff. CHAMP (Creating Healthy Habits Among Maryland Preschoolers) is a 3-arm cluster randomized controlled childhood obesity prevention trial, aiming to improve motor skills, physical activity and willingness to try new foods among 864 preschoolers (age 3–5 years) enrolled in 54 child care centers in 10 Maryland counties. CHAMP is informed by social-cognitive and bioecological theories and based on an evidence-based program, The Food Friends®. The two intervention arms include: 1) child care-center based lessons (18-week gross motor and 12-week nutrition) administered by trained child care staff, and 2) a web-based intervention for caregivers in addition to center-based lessons. Evaluations are conducted among children, caregivers, and child care staff at fall enrollment, midline, and spring, following intervention completion. Analyses include linear mixed-models, accounting for clustering and repeated measures, incorporating center-arms as moderators. CHAMP will provide evidence-based information to inform wellness guidelines and policies that can be disseminated broadly, to ensure that child care centers provide opportunities for children to develop healthy eating, and physical activity habits. Trial Registration: NCT03111264 ; https://clinicaltrials.gov/ct2/show/NCT03111264 [ABSTRACT FROM AUTHOR]

The recent Ebola virus epidemic was waning by the time stakeholders were ready to field vaccines for testing but an evidence-based response to a novel pathogen will surely be required again. Here, we present a design for such a randomized controlled trial. The permuted locus trial was originally intended for studying the influence of water wells on trachoma. While outcomes can be measured in individuals, neither individuals nor groups are themselves randomized to arms, just potential well-sites, or in the case of an epidemic, index cases. The permuted locus trial may be used when classic individual and cluster-randomized trial design and analyses may not be optimal. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: To assess the impact of a hygiene-encouragement program on reducing infection rates (primary end point) by 5%. Design: A cluster randomized study was carried out over a 5-month period. Settings and participants: Fifty nursing homes (NHs) with 4345 beds in France were randomly assigned by stratified-block randomization to either a multicomponent intervention (25 NHs) or an assessment only (25 NHs). Intervention: The multicomponent intervention was targeted to caregivers and consisted of implementing a bundle of infection prevention consensual measures. Interactive educational meetings using a slideshow were organized at the intervention NHs. The NHs were also provided with color posters emphasizing hand hygiene and a kit that included hygienic products such as alcoholic-based hand sanitizers. Knowledge surveys were performed periodically and served as reminders. Measurements: The primary end point was the total infection rate (urinary, respiratory, and gastrointestinal infections) in those infection cases classified either as definite or probable. Analyses corresponded to the underlying design and were performed according to the intention-to-treat principle. This study was registered (#NCT01069497). Results: Forty-seven NHs (4515 residents) were included and followed. The incidence rate of the first episode of infection was 2.11 per 1000 resident-days in the interventional group and 2.15 per 1000 resident-days in the control group; however, the difference between the groups did not reach statistical significance in either the unadjusted (Hazard Ratio [HR] = 1.00 [95% confidence interval (CI) 0.89–1.13]; P = .93]) or the adjusted (HR = 0.99 [95% CI 0.87–1.12]; P = .86]) analysis. Conclusion: Disentangling the impact of this type of intervention involving behavioral change in routine practice in caregivers from the prevailing environmental and contextual determinants is often complicated and confusing to interpret the results. [Copyright &y& Elsevier]