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Objectives: Responsible workplaces strive to minimize the harmful effects of alcohol and drug abuse. However, gambling is still a neglected area in workplace research. This study describes workplace gambling and investigates variables associated with at-risk problem gambling and knowing about colleagues who gambles during work, using cross-sectional data from a large cluster-randomized controlled trial on gambling prevention in the workplace (N=3629). Methods: Measures included prevalence of workplace gambling policies, at-risk and problem gambling, and knowledge about colleagues who gamble during work. Results: Of the respondents, 168 (4.7%) knew of someone who gambles at work, of whom 29 (17.3%) also worried about the harmful consequences of workplace gambling. Moreover, 395 (11.2%) believed that a gambling policy existed in their workplace. Knowing about a colleague who gambles during work was more common among employees who were men (OR = 2.98), aged 16–34 (OR = 1.97), knew about a gambling policy (OR = 1.57), and who themselves were classified as at-risk problem gamblers (OR = 2.95). Similarly, being classified as an at-risk problem gambler was significantly associated with being male (OR = 2.14), aged 16–34 (OR = 2.35) or 35–44 (OR=2.36), being a subordinate (OR = 2.53), and knowing about a colleague who gambles during work (OR=4). Conclusions: Gambling during work is a prevalent phenomenon. Organizations should consider implementing gambling policies that facilitate helping workers who are problem gamblers. To determine policy contents and measures to implement, the type of gambling and its effect on employees should be explored., This study was funded by the Public Health Agency of Sweden.

Heart failure is a prevalent condition and a frequent cause of hospital readmissions and poor quality of life. Teleconsultation support from cardiologists to primary care physicians managing patients with heart failure may improve care, but the effect on patient-relevant outcomes is unclear. We aim to evaluate whether collaboration through a novel teleconsultation platform in the Brazilian Heart Insufficiency with Telemedicine (BRAHIT) project, tested on a previous feasibility study, can improve patient-relevant outcomes. We will conduct a parallel-group, two-arm, cluster-randomised superiority trial with a 1:1 allocation ratio, with primary care practices from Rio de Janeiro as clusters. Physicians from the intervention group practices will receive teleconsultation support from a cardiologist to assist patients discharged from hospitals after admission for heart failure. In contrast, physicians from the control group practices will perform usual care. We will include 10 patients per each of the 80 enrolled practices (n = 800). The primary outcome will be a composite of mortality and hospital admissions after six months. Secondary outcomes will be adverse events, symptoms frequency, quality of life, and primary care physicians’ compliance with treatment guidelines. We hypothesise that teleconsulting support will improve patient outcomes.

bjective The MAMAACT intervention aims to reduce ethnic and social disparities in stillbirth and infant death by improving communication between pregnant women and midwives regarding warning signs of pregnancy complications. This study evaluates the effect of the intervention on pregnant women's health literacy (two domains from the Health Literacy Questionnaire) and complication management — interpreted as improved health literacy responsiveness among midwives. Design Cluster randomized controlled trial, 2018–2019. Setting 19 of 20 Danish maternity wards. Participants Cross-sectional survey data were collected using telephone interviews (n = 4150 pregnant women including 670 women with a non-Western immigrant background). Intervention A six-hour training session for midwives in intercultural communication and cultural competence, two follow-up dialog meetings, and health education materials for pregnant women on warning signs of pregnancy complications — in six languages. Main outcome measures Differences in mean scores at post-implementation of the domains Active engagement with healthcare providers (Active engagement) and Navigating the healthcare system from the Health Literacy Questionnaire, and differences in the certainty of how to respond to pregnancy complication signs between women in the intervention and control group. Results No difference was observed in women's level of Active engagement or Navigating the healthcare system. Women from the intervention group were more certain of how to respond to complication signs: Redness, swelling, and heat in one leg: 69.4 % vs 59.1 %; aOR 1.57 (95 % CI 1.32–1.88), Severe headache: 75.6 % vs 67.3 %; aOR 1.50 (95 % CI 1.24–1.82), and Vaginal bleeding: 97.3 % vs 95.1 %; aOR 1.67 (95 % CI 1.04–2.66). Conclusion The intervention improved women's certainty of how to respond to complication signs, but was unable to improve pregn, Objective: The MAMAACT intervention aims to reduce ethnic and social disparities in stillbirth and infant death by improving communication between pregnant women and midwives regarding warning signs of pregnancy complications. This study evaluates the effect of the intervention on pregnant women's health literacy (two domains from the Health Literacy Questionnaire) and complication management — interpreted as improved health literacy responsiveness among midwives. Design: Cluster randomized controlled trial, 2018–2019. Setting: 19 of 20 Danish maternity wards. Participants: Cross-sectional survey data were collected using telephone interviews (n = 4150 pregnant women including 670 women with a non-Western immigrant background). Intervention: A six-hour training session for midwives in intercultural communication and cultural competence, two follow-up dialog meetings, and health education materials for pregnant women on warning signs of pregnancy complications — in six languages. Main outcome measures: Differences in mean scores at post-implementation of the domains Active engagement with healthcare providers (Active engagement) and Navigating the healthcare system from the Health Literacy Questionnaire, and differences in the certainty of how to respond to pregnancy complication signs between women in the intervention and control group. Results: No difference was observed in women's level of Active engagement or Navigating the healthcare system. Women from the intervention group were more certain of how to respond to complication signs: Redness, swelling, and heat in one leg: 69.4 % vs 59.1 %; aOR 1.57 (95 % CI 1.32–1.88), Severe headache: 75.6 % vs 67.3 %; aOR 1.50 (95 % CI 1.24–1.82), and Vaginal bleeding: 97.3 % vs 95.1 %; aOR 1.67 (95 % CI 1.04–2.66). Conclusion: The intervention improved women's certainty of how to respond to complication signs, but was unable to improve pregnant women's health literacy levels of Active engagement and Navigating the healthca

Background: It has been more than 20 years since the malaria epidemiologic shift to school-aged children was noted. In the meantime, school-aged children (5–15 years) have become increasingly more vulnerable with asymptomatic malaria prevalence reaching up to 70%, making them reservoirs for subsequent transmission of malaria in the endemic communities. Intermittent Preventive Treatment of malaria in schoolchildren (IPTsc) has proven to be an effective tool to shrink this reservoir. As of 3rd June 2022, the World Health Organization recommends IPTsc in moderate and high endemic areas. Even so, for decision-makers, the adoption of scientific research recommendations has been stifled by real-world implementation challenges. This study presents methodology, challenges faced, and mitigations used in the evaluation of the implementation of IPTsc using dihydroartemisinin-piperaquine (DP) in three councils (Handeni District Council (DC), Handeni Town Council (TC) and Kilindi DC) of Tanga Region, Tanzania so as to understand the operational feasibility and effectiveness of IPTsc on malaria parasitaemia and clinical malaria incidence. Methods: The study deployed an effectiveness-implementation hybrid design to assess feasibility and effectiveness of IPTsc using DP, the interventional drug, against standard of care (control). Wards in the three study councils were the randomization unit (clusters). Each ward was randomized to implement IPTsc or not (control). In all wards in the IPTsc arm, DP was given to schoolchildren three times a year in four-month intervals. In each council, 24 randomly selected wards (12 per study arm, one school per ward) were chosen as representatives for intervention impact evaluation. Mixed design methods were used to assess the feasibility and acceptability of implementing IPTsc as part of a more comprehensive health package for schoolchildren. The study reimagined an existing school health programme for Neglected Tropical Diseases (NT

Background: It has been more than 20 years since the malaria epidemiologic shift to school-aged children was noted. In the meantime, school-aged children (5–15 years) have become increasingly more vulnerable with asymptomatic malaria prevalence reaching up to 70%, making them reservoirs for subsequent transmission of malaria in the endemic communities. Intermittent Preventive Treatment of malaria in schoolchildren (IPTsc) has proven to be an effective tool to shrink this reservoir. As of 3rd June 2022, the World Health Organization recommends IPTsc in moderate and high endemic areas. Even so, for decision-makers, the adoption of scientific research recommendations has been stifled by real-world implementation challenges. This study presents methodology, challenges faced, and mitigations used in the evaluation of the implementation of IPTsc using dihydroartemisinin-piperaquine (DP) in three councils (Handeni District Council (DC), Handeni Town Council (TC) and Kilindi DC) of Tanga Region, Tanzania so as to understand the operational feasibility and effectiveness of IPTsc on malaria parasitaemia and clinical malaria incidence. Methods: The study deployed an effectiveness-implementation hybrid design to assess feasibility and effectiveness of IPTsc using DP, the interventional drug, against standard of care (control). Wards in the three study councils were the randomization unit (clusters). Each ward was randomized to implement IPTsc or not (control). In all wards in the IPTsc arm, DP was given to schoolchildren three times a year in four-month intervals. In each council, 24 randomly selected wards (12 per study arm, one school per ward) were chosen as representatives for intervention impact evaluation. Mixed design methods were used to assess the feasibility and acceptability of implementing IPTsc as part of a more comprehensive health package for schoolchildren. The study reimagined an existing school health programme for Neglected Tropical Diseases (NT

ObjectiveWe examine the efficacy of short message service (SMS) and SMS with peer navigation (SMS + PN) in improving linkage to HIV care and initiation of antiretroviral therapy (ART).DesignI-Care was a cluster randomized trial conducted in primary care facilities in North West Province, South Africa. The primary study outcome was retention in HIV care; this analysis includes secondary outcomes: linkage to care and ART initiation.MethodsEighteen primary care clinics were randomized to automated SMS ( n = 7), automated and tailored SMS + PN ( n = 7), or standard of care (SOC; n = 4). Recently HIV diagnosed adults ( n = 752) were recruited from October 2014 to April 2015. Those not previously linked to care ( n = 352) contributed data to this analysis. Data extracted from clinical records were used to assess the days that elapsed between diagnosis and linkage to care and ART initiation. Cox proportional hazards models and generalized estimating equations were employed to compare outcomes between trial arms, overall and stratified by sex and pregnancy status.ResultsOverall, SMS ( n = 132) and SMS + PN ( n = 133) participants linked at 1.28 [95% confidence interval (CI): 1.01-1.61] and 1.60 (95% CI: 1.29-1.99) times the rate of SOC participants ( n = 87), respectively. SMS + PN significantly improved time to ART initiation among non-pregnant women (hazards ratio: 1.68; 95% CI: 1.25-2.25) and men (hazards ratio: 1.83; 95% CI: 1.03-3.26) as compared with SOC.ConclusionResults suggest SMS and peer navigation services significantly reduce time to linkage to HIV care in sub-Saharan Africa and that SMS + PN reduced time to ART initiation among men and non-pregnant women. Both should be considered candidates for integration into national programs.Trial registrationNCT02417233, registered 12 December 2014; closed to accrual 17 April 2015.

bjective The MAMAACT intervention aims to reduce ethnic and social disparities in stillbirth and infant death by improving communication between pregnant women and midwives regarding warning signs of pregnancy complications. This study evaluates the effect of the intervention on pregnant women's health literacy (two domains from the Health Literacy Questionnaire) and complication management — interpreted as improved health literacy responsiveness among midwives. Design Cluster randomized controlled trial, 2018–2019. Setting 19 of 20 Danish maternity wards. Participants Cross-sectional survey data were collected using telephone interviews (n = 4150 pregnant women including 670 women with a non-Western immigrant background). Intervention A six-hour training session for midwives in intercultural communication and cultural competence, two follow-up dialog meetings, and health education materials for pregnant women on warning signs of pregnancy complications — in six languages. Main outcome measures Differences in mean scores at post-implementation of the domains Active engagement with healthcare providers (Active engagement) and Navigating the healthcare system from the Health Literacy Questionnaire, and differences in the certainty of how to respond to pregnancy complication signs between women in the intervention and control group. Results No difference was observed in women's level of Active engagement or Navigating the healthcare system. Women from the intervention group were more certain of how to respond to complication signs: Redness, swelling, and heat in one leg: 69.4 % vs 59.1 %; aOR 1.57 (95 % CI 1.32–1.88), Severe headache: 75.6 % vs 67.3 %; aOR 1.50 (95 % CI 1.24–1.82), and Vaginal bleeding: 97.3 % vs 95.1 %; aOR 1.67 (95 % CI 1.04–2.66). Conclusion The intervention improved women's certainty of how to respond to complication signs, but was unable to improve pregn, Objective: The MAMAACT intervention aims to reduce ethnic and social disparities in stillbirth and infant death by improving communication between pregnant women and midwives regarding warning signs of pregnancy complications. This study evaluates the effect of the intervention on pregnant women's health literacy (two domains from the Health Literacy Questionnaire) and complication management — interpreted as improved health literacy responsiveness among midwives. Design: Cluster randomized controlled trial, 2018–2019. Setting: 19 of 20 Danish maternity wards. Participants: Cross-sectional survey data were collected using telephone interviews (n = 4150 pregnant women including 670 women with a non-Western immigrant background). Intervention: A six-hour training session for midwives in intercultural communication and cultural competence, two follow-up dialog meetings, and health education materials for pregnant women on warning signs of pregnancy complications — in six languages. Main outcome measures: Differences in mean scores at post-implementation of the domains Active engagement with healthcare providers (Active engagement) and Navigating the healthcare system from the Health Literacy Questionnaire, and differences in the certainty of how to respond to pregnancy complication signs between women in the intervention and control group. Results: No difference was observed in women's level of Active engagement or Navigating the healthcare system. Women from the intervention group were more certain of how to respond to complication signs: Redness, swelling, and heat in one leg: 69.4 % vs 59.1 %; aOR 1.57 (95 % CI 1.32–1.88), Severe headache: 75.6 % vs 67.3 %; aOR 1.50 (95 % CI 1.24–1.82), and Vaginal bleeding: 97.3 % vs 95.1 %; aOR 1.67 (95 % CI 1.04–2.66). Conclusion: The intervention improved women's certainty of how to respond to complication signs, but was unable to improve pregnant women's health literacy levels of Active engagement and Navigating the healthca

Heart failure is a prevalent condition and a frequent cause of hospital readmissions and poor quality of life. Teleconsultation support from cardiologists to primary care physicians managing patients with heart failure may improve care, but the effect on patient-relevant outcomes is unclear. We aim to evaluate whether collaboration through a novel teleconsultation platform in the Brazilian Heart Insufficiency with Telemedicine (BRAHIT) project, tested on a previous feasibility study, can improve patient-relevant outcomes. We will conduct a parallel-group, two-arm, cluster-randomised superiority trial with a 1:1 allocation ratio, with primary care practices from Rio de Janeiro as clusters. Physicians from the intervention group practices will receive teleconsultation support from a cardiologist to assist patients discharged from hospitals after admission for heart failure. In contrast, physicians from the control group practices will perform usual care. We will include 10 patients per each of the 80 enrolled practices (n = 800). The primary outcome will be a composite of mortality and hospital admissions after six months. Secondary outcomes will be adverse events, symptoms frequency, quality of life, and primary care physicians’ compliance with treatment guidelines. We hypothesise that teleconsulting support will improve patient outcomes.

Stepped wedge design (SWD) trials are cluster randomized trials that feature staggered, unidirectional cross-over between treatment conditions. Existing literature for SWDs focuses primarily on designs with two conditions, typically a control and an intervention condition, and a continuous outcome. The work for this dissertation is motivated by the NORVAX study, a SWD trial implemented at clinics in a safety-net health system to estimate the effectiveness of two interventions for promoting HPV vaccination among adolescents. The outcome for the NORVAX study is patient vaccination status, which is a multistate outcome (no doses, one dose, or two doses). This dissertation has two parts that make contributions to the literature regarding two salient features of the NORVAX study: the multiple interventions in a SWD and the multistate vaccination status outcome.The first part of this dissertation develops methods for conducting power calculations for SWDs with multiple treatment conditions and a continuous outcome. We present a linear mixed model for such designs and derive standard errors of the intervention effect coefficients. Power for detecting intervention effects is calculated analytically assuming a normally distributed Wald test statistic under an alternative hypothesis. We apply the proposed method to both repeated cross-sectional and cohort designs. Design features, with a focus on treatment sequencing across periods, are examined to determine their impact on power. Simulations are used to verify results. %For factorial designs, power is maximized by allowing clusters to transition to several different treatment conditions. Power is maximized in multi-arm trials by ensuring each treatment condition is introduced early enough in the SWD.The second part of this dissertation focuses on the vaccination status outcome and quantifying intervention effects for this outcome within the context of a SWD. A goal of the NORVAX study is to estimate intervention effects as c

Stepped wedge design (SWD) trials are cluster randomized trials that feature staggered, unidirectional cross-over between treatment conditions. Existing literature for SWDs focuses primarily on designs with two conditions, typically a control and an intervention condition, and a continuous outcome. The work for this dissertation is motivated by the NORVAX study, a SWD trial implemented at clinics in a safety-net health system to estimate the effectiveness of two interventions for promoting HPV vaccination among adolescents. The outcome for the NORVAX study is patient vaccination status, which is a multistate outcome (no doses, one dose, or two doses). This dissertation has two parts that make contributions to the literature regarding two salient features of the NORVAX study: the multiple interventions in a SWD and the multistate vaccination status outcome.The first part of this dissertation develops methods for conducting power calculations for SWDs with multiple treatment conditions and a continuous outcome. We present a linear mixed model for such designs and derive standard errors of the intervention effect coefficients. Power for detecting intervention effects is calculated analytically assuming a normally distributed Wald test statistic under an alternative hypothesis. We apply the proposed method to both repeated cross-sectional and cohort designs. Design features, with a focus on treatment sequencing across periods, are examined to determine their impact on power. Simulations are used to verify results. %For factorial designs, power is maximized by allowing clusters to transition to several different treatment conditions. Power is maximized in multi-arm trials by ensuring each treatment condition is introduced early enough in the SWD.The second part of this dissertation focuses on the vaccination status outcome and quantifying intervention effects for this outcome within the context of a SWD. A goal of the NORVAX study is to estimate intervention effects as c

Background: Healthcare costs are rising, and a substantial proportion of medical care is of little value. De-implementation of low-value practices is important for improving overall health outcomes and reducing costs. We aimed to identify and synthesize randomized controlled trials (RCTs) on de-implementation interventions and to provide guidance to improve future research. Methods: MEDLINE and Scopus up to May 24, 2021, for individual and cluster RCTs comparing de-implementation interventions to usual care, another intervention, or placebo. We applied independent duplicate assessment of eligibility, study characteristics, outcomes, intervention categories, implementation theories, and risk of bias. Results: Of the 227 eligible trials, 145 (64%) were cluster randomized trials (median 24 clusters; median follow-up time 305 days), and 82 (36%) were individually randomized trials (median follow-up time 274 days). Of the trials, 118 (52%) were published after 2010, 149 (66%) were conducted in a primary care setting, 163 (72%) aimed to reduce the use of drug treatment, 194 (85%) measured the total volume of care, and 64 (28%) low-value care use as outcomes. Of the trials, 48 (21%) described a theoretical basis for the intervention, and 40 (18%) had the study tailored by context-specific factors. Of the de-implementation interventions, 193 (85%) were targeted at physicians, 115 (51%) tested educational sessions, and 152 (67%) multicomponent interventions. Missing data led to high risk of bias in 137 (60%) trials, followed by baseline imbalances in 99 (44%), and deficiencies in allocation concealment in 56 (25%). Conclusions: De-implementation trials were mainly conducted in primary care and typically aimed to reduce low-value drug treatments. Limitations of current de-implementation research may have led to unreliable effect estimates and decreased clinical applicability of studied de-implementation strategies. We identified potential research gaps, including de

Background and Aims: This study evaluated whether a preventive intervention program for problem gambling would increase managers' inclination to act when concerned about gambling in the workplace. Design: Cluster randomized controlled trial. Ten workplaces were randomized to either intervention or control condition. Participants: At the 12-month endpoint, there were n = 136 managers and n = 1594 subordinates in the intervention group, and n = 137 managers and n = 1150 subordinates in the waitlist group. Intervention: The intervention consisted of (1) six hours of skill-development training for managers regarding gambling, problem gambling, gaming, and harmful use of psychoactive drugs, and (2) six to eight hours of assistance in developing or improving workplace gambling policy. Measurements: The primary outcome was the managers' self-rated (on a 1 to 10 scale) inclination to act when concerned about an employee's problem gambling 12 months after baseline. Findings: The between -group difference in the managers' inclination for the full intervention group (M = 8) and the control group (M = 7.4) was not significant at the 12-month follow-up, but it was when only including managers who attended the skill development training (M = 8.2), d = 0.31, p = .04. Conclusion: A workplace prevention program aimed to increase managers' inclination to act when they are concerned regarding an employee's gambling resulted in statistically significant changes for those who attended training, but not for the whole intervention group when non-attendees were included.

Background and Aims: This study evaluated whether a preventive intervention program for problem gambling would increase managers' inclination to act when concerned about gambling in the workplace. Design: Cluster randomized controlled trial. Ten workplaces were randomized to either intervention or control condition. Participants: At the 12-month endpoint, there were n = 136 managers and n = 1594 subordinates in the intervention group, and n = 137 managers and n = 1150 subordinates in the waitlist group. Intervention: The intervention consisted of (1) six hours of skill-development training for managers regarding gambling, problem gambling, gaming, and harmful use of psychoactive drugs, and (2) six to eight hours of assistance in developing or improving workplace gambling policy. Measurements: The primary outcome was the managers' self-rated (on a 1 to 10 scale) inclination to act when concerned about an employee's problem gambling 12 months after baseline. Findings: The between -group difference in the managers' inclination for the full intervention group (M = 8) and the control group (M = 7.4) was not significant at the 12-month follow-up, but it was when only including managers who attended the skill development training (M = 8.2), d = 0.31, p = .04. Conclusion: A workplace prevention program aimed to increase managers' inclination to act when they are concerned regarding an employee's gambling resulted in statistically significant changes for those who attended training, but not for the whole intervention group when non-attendees were included.

IntroductionIn low- and middle-income countries, children experience multiple risks for delayed development. We evaluated a multicomponent, group-based early child development intervention including behavioural recommendations on responsive stimulation, nutrition, water, sanitation, hygiene, mental health and lead exposure prevention.MethodsWe conducted a 9-month, parallel, multiarm, cluster-randomised controlled trial in 31 rural villages in Kishoreganj District, Bangladesh. Villages were randomly allocated to: group sessions ('group'); alternating groups and home visits ('combined'); or a passive control arm. Sessions were delivered fortnightly by trained community members. The primary outcome was child stimulation (Family Care Indicators); the secondary outcome was child development (Ages and Stages Questionnaire Inventory, ASQi). Other outcomes included dietary diversity, latrine status, use of a child potty, handwashing infrastructure, caregiver mental health and knowledge of lead. Analyses were intention to treat. Data collectors were independent from implementers.ResultsIn July-August 2017, 621 pregnant women and primary caregivers of children<15 months were enrolled (group n=160, combined n=160, control n=301). At endline, immediately following intervention completion (July-August 2018), 574 participants were assessed (group n=144, combined n=149, control n=281). Primary caregivers in both intervention arms participated in more play activities than control caregivers (age-adjusted means: group 4.22, 95% CI 3.97 to 4.47; combined 4.77, 4.60 to 4.96; control 3.24, 3.05 to 3.39), and provided a larger variety of play materials (age-adjusted means: group 3.63, 3.31 to 3.96; combined 3.81, 3.62 to 3.99; control 2.48, 2.34 to 2.59). Compared with the control arm, children in the group arm had higher total ASQi scores (adjusted mean difference in standardised scores: 0.39, 0.15 to 0.64), while in the combined arm scores were not significantly different from the

In low- and middle-income countries, children experience multiple risks for delayed development. We evaluated a multicomponent, group-based early child development intervention including behavioural recommendations on responsive stimulation, nutrition, water, sanitation, hygiene, mental health and lead exposure prevention. We conducted a 9-month, parallel, multiarm, cluster-randomised controlled trial in 31 rural villages in Kishoreganj District, Bangladesh. Villages were randomly allocated to: group sessions ('group'); alternating groups and home visits ('combined'); or a passive control arm. Sessions were delivered fortnightly by trained community members. The primary outcome was child stimulation (Family Care Indicators); the secondary outcome was child development (Ages and Stages Questionnaire Inventory, ASQi). Other outcomes included dietary diversity, latrine status, use of a child potty, handwashing infrastructure, caregiver mental health and knowledge of lead. Analyses were intention to treat. Data collectors were independent from implementers. In July-August 2017, 621 pregnant women and primary caregivers of children<15 months were enrolled (group n=160, combined n=160, control n=301). At endline, immediately following intervention completion (July-August 2018), 574 participants were assessed (group n=144, combined n=149, control n=281). Primary caregivers in both intervention arms participated in more play activities than control caregivers (age-adjusted means: group 4.22, 95% CI 3.97 to 4.47; combined 4.77, 4.60 to 4.96; control 3.24, 3.05 to 3.39), and provided a larger variety of play materials (age-adjusted means: group 3.63, 3.31 to 3.96; combined 3.81, 3.62 to 3.99; control 2.48, 2.34 to 2.59). Compared with the control arm, children in the group arm had higher total ASQi scores (adjusted mean difference in standardised scores: 0.39, 0.15 to 0.64), while in the combined arm scores were not significantly different from the control (0.25, -0.07 to

Lead exposure is harmful at any time in life, but pre-natal and early childhood exposures are particularly detrimental to cognitive development. In Bangladesh, multiple household-level lead exposures pose risks, including turmeric adulterated with lead chromate and food storage in lead-soldered cans. We developed and evaluated an intervention to reduce lead exposure among children and their caregivers in rural Bangladesh. We conducted formative research to inform theory-based behavioral recommendations. Lead exposure was one of several topics covered in the multi-component intervention focused on early child development. Community health workers (CHWs) delivered the lead component of the intervention during group sessions with pregnant women and mother-child dyads (<15 months old) in a cluster-randomized trial. We administered household surveys at baseline (control n = 301; intervention n = 320) and 9 months later at endline (control n = 279; intervention n = 239) and calculated adjusted risk and mean differences for primary outcomes. We conducted two qualitative assessments, one after 3 months and a second after 9 months, to examine the feasibility and benefits of the intervention. At endline, the prevalence of lead awareness was 52 percentage points higher in the intervention arm compared to the control (adjusted risk difference: 0.52 [95% CI 0.46 to 0.61]). Safe turmeric consumption and food storage practices were more common in the intervention versus control arm at endline, with adjusted risk differences of 0.22 [0.10 to 0.32] and 0.13 [0.00 to 0.19], respectively. Semi-structured interviews conducted with a subset of participants after the intervention revealed that the perceived benefit of reducing lead exposure was high because of the long-term negative impacts that lead can have on child cognitive development. The study demonstrates that a group-based CHW-led intervention can effectively raise awareness about and m

Introduction: South Asians are at high risk of type 2 diabetes (T2D). We assessed whether intensive family-based lifestyle intervention leads to significant weight loss, improved glycaemia and blood pressure in adults at elevated risk for T2D. Methods: This cluster randomised controlled trial (iHealth-T2D) was conducted at 120 locations across India, Pakistan, Sri Lanka and the UK. We included 3684 South Asian men and women, aged 40–70 years, without T2D but with raised haemoglobin A1c (HbA1c) and/or waist circumference. Participants were randomly allocated either to the family-based lifestyle intervention or control group by location clusters. Participants in the intervention received 9 visits and 13 telephone contacts by community health workers over 1-year period, and the control group received usual care. Reductions in weight (aim >7% reduction), waist circumference (aim ≥5 cm reduction), blood pressure and HbA1C at 12 months of follow-up were assessed. Our linear mixed-effects regression analysis was based on intention-to-treat principle and adjusted for age, sex and baseline values. Results: There were 1846 participants in the control and 1838 in the intervention group. Between baseline and 12 months, mean weight of participants in the intervention group reduced by 1.8 kg compared with 0.4 kg in the control group (adjusted mean difference −1.10 kg (95% CI −1.70 to −1.06), p<0.001). The adjusted mean difference for waist circumference was −1.9 cm (95% CI −2.5; to 1.3), p<0.001). No overall difference was observed for blood pressure or HbA1c. People who attended multiple intervention sessions had a dose-dependent effect on waist circumference, blood pressure and HbA1c, but not on weight. Conclusion: An intensive family-based lifestyle intervention adopting low-resource strategies led to effective reduction in weight and waist circumference at 12 months, which has potential long-term benefits for preventing T2D. A higher number of attended sessi

BACKGROUND: Universal tobacco-prevention programs targeting youths usually involve significant adults, who are assumed to be important social influences. Commitment not to use tobacco, or to quit use, as a formal contract between an adolescent and a significant adult is a preventive model that has not been widely practiced or explored and has been formally evaluated even less. In this paper, we present the rationale and protocol for the evaluation of the Swedish Tobacco-free Duo program, a multicomponent school-based program the core of which rests on a formal agreement between an adolescent and an adult. The adolescent's commitment mainly concerns avoiding the onset of any tobacco use while the adult commits to support the adolescent in staying tobacco free, being a role model by not using tobacco themselves. OBJECTIVE: To assess (1) whether Tobacco-free Duo is superior to an education-only program in preventing smoking onset among adolescents and promoting cessation among their parents, (2) whether exposure to core components (adult-child agreement) entails more positive effects than exposure to other components, (3) the impact of the program on whole school tobacco use, (4) potential negative side effects, and (5) school-level factors related to fidelity of the program's implementation. METHODS: A mixed-design approach was developed. First, a cluster randomized controlled trial was designed with schools randomly assigned to either the comprehensive multicomponent program or its educational component only. Primary outcome at the adolescent level was identified as not having tried tobacco during the 3-year junior high school compulsory grades (12-15 years of age). An intention-to-treat cohort-wise approach and an as-treated approach complemented with a whole school repeated cross-sectional approach was devised as analytical methods of the trial data. Second, an observational study was added in order to compare smoking incidence in the schools participating in the e

BACKGROUND: Universal tobacco-prevention programs targeting youths usually involve significant adults, who are assumed to be important social influences. Commitment not to use tobacco, or to quit use, as a formal contract between an adolescent and a significant adult is a preventive model that has not been widely practiced or explored and has been formally evaluated even less. In this paper, we present the rationale and protocol for the evaluation of the Swedish Tobacco-free Duo program, a multicomponent school-based program the core of which rests on a formal agreement between an adolescent and an adult. The adolescent's commitment mainly concerns avoiding the onset of any tobacco use while the adult commits to support the adolescent in staying tobacco free, being a role model by not using tobacco themselves. OBJECTIVE: To assess (1) whether Tobacco-free Duo is superior to an education-only program in preventing smoking onset among adolescents and promoting cessation among their parents, (2) whether exposure to core components (adult-child agreement) entails more positive effects than exposure to other components, (3) the impact of the program on whole school tobacco use, (4) potential negative side effects, and (5) school-level factors related to fidelity of the program's implementation. METHODS: A mixed-design approach was developed. First, a cluster randomized controlled trial was designed with schools randomly assigned to either the comprehensive multicomponent program or its educational component only. Primary outcome at the adolescent level was identified as not having tried tobacco during the 3-year junior high school compulsory grades (12-15 years of age). An intention-to-treat cohort-wise approach and an as-treated approach complemented with a whole school repeated cross-sectional approach was devised as analytical methods of the trial data. Second, an observational study was added in order to compare smoking incidence in the schools participating in the e

BACKGROUND: Universal tobacco-prevention programs targeting youths usually involve significant adults, who are assumed to be important social influences. Commitment not to use tobacco, or to quit use, as a formal contract between an adolescent and a significant adult is a preventive model that has not been widely practiced or explored and has been formally evaluated even less. In this paper, we present the rationale and protocol for the evaluation of the Swedish Tobacco-free Duo program, a multicomponent school-based program the core of which rests on a formal agreement between an adolescent and an adult. The adolescent's commitment mainly concerns avoiding the onset of any tobacco use while the adult commits to support the adolescent in staying tobacco free, being a role model by not using tobacco themselves. OBJECTIVE: To assess (1) whether Tobacco-free Duo is superior to an education-only program in preventing smoking onset among adolescents and promoting cessation among their parents, (2) whether exposure to core components (adult-child agreement) entails more positive effects than exposure to other components, (3) the impact of the program on whole school tobacco use, (4) potential negative side effects, and (5) school-level factors related to fidelity of the program's implementation. METHODS: A mixed-design approach was developed. First, a cluster randomized controlled trial was designed with schools randomly assigned to either the comprehensive multicomponent program or its educational component only. Primary outcome at the adolescent level was identified as not having tried tobacco during the 3-year junior high school compulsory grades (12-15 years of age). An intention-to-treat cohort-wise approach and an as-treated approach complemented with a whole school repeated cross-sectional approach was devised as analytical methods of the trial data. Second, an observational study was added in order to compare smoking incidence in the schools participating in the e

BackgroundDelays in diagnosis and treatment of tuberculosis (TB) remain common in high-burden countries. To improve case detection, substantial investments have been made to scale-up Xpert MTB/RIF (Xpert), a cartridge-based nucleic acid amplification test that can detect TB within 2 hours, as a replacement for sputum smear microscopy. However, the optimal strategy for implementation of Xpert testing remains unclear.MethodsThe Xpert Performance Evaluation for Linkage to Tuberculosis Care (XPEL-TB) trial uses an ultra-pragmatic, hybrid type II effectiveness-implementation design to assess the effectiveness and implementation of a streamlined strategy for delivery of Xpert testing in real-world settings. Twenty health centers with TB microscopy units were selected to participate in the trial, with ten health centers randomized to the intervention strategy (onsite molecular testing using GeneXpert Edge, process redesign to facilitate same-day TB diagnosis and treatment, and performance feedback) or routine care (onsite sputum smear microscopy plus referral of sputum samples to Xpert testing sites). The primary outcome is the number of patients with microbiologically confirmed TB who were initiated on treatment within 14 days of presentation to the health center, which reflects successful completion of the TB diagnostic evaluation process. Secondary outcomes include health outcomes (6-month vital status), as well as measures of the reach, adoption, and implementation of the intervention strategy.DiscussionThe design elements and implementation approach for the XPEL-TB trial were intentionally selected to minimize disruptions to routine care procedures, with the goal of limiting their influence on key primary and secondary outcomes. Trial findings may result in increased support and funding for rapid, onsite molecular testing as the standard-of-care for all patients being evaluated for TB.Trial registrationUS National Institutes of Health's ClinicalTrials.gov, NCT03044158

BackgroundAntiretroviral therapy (ART) for HIV, taken daily, is an effective strategy to clinically suppress the virus, providing the dual benefit of improved survival and vastly decreasing the risk of transmission. However, this highly effective intervention has not yet reached all who could benefit. Cash transfers are increasingly recognized as an effective strategy to motivate behavior change and improve HIV care and treatment outcomes, including engagement in HIV care and adherence to ART. Despite a growing evidence base and strong theoretical foundation for the cash transfer approach, key questions remain. To address these questions and begin to bridge the "know-do gap" with respect to cash transfers, our team is employing an implementation science approach to iterative development of an incentive-based intervention to promote ART uptake and adherence among people living with HIV (PLHIV) in the Lake Zone region, Tanzania.MethodsWe will conduct a type I hybrid implementation-effectiveness trial to test the effectiveness of a cash transfer intervention on the outcome of HIV viral suppression, and concurrently examine the potential for real-world implementation with a mobile health technology (mHealth) system. Specifically, our team will expand the intervention to 32 clinics and enroll 1984 PLHIV to (a) evaluate its effectiveness by conducting a cluster randomized controlled trial with clinics as the unit of randomization and 12-month viral suppression as the primary outcome and (b) evaluate the implementation challenges and successes at multiple levels (patient, provider, clinic).DiscussionThis trial will provide evidence not only about the real-world effectiveness of cash transfers for retention in HIV care and viral suppression, but also on the implementation challenges and successes that will facilitate or hinder wider scale-up within Tanzania and beyond.Trial registrationClinicalTrials.gov NCT04201353 . Registered on December 17, 2019.

BackgroundDelays in diagnosis and treatment of tuberculosis (TB) remain common in high-burden countries. To improve case detection, substantial investments have been made to scale-up Xpert MTB/RIF (Xpert), a cartridge-based nucleic acid amplification test that can detect TB within 2 hours, as a replacement for sputum smear microscopy. However, the optimal strategy for implementation of Xpert testing remains unclear.MethodsThe Xpert Performance Evaluation for Linkage to Tuberculosis Care (XPEL-TB) trial uses an ultra-pragmatic, hybrid type II effectiveness-implementation design to assess the effectiveness and implementation of a streamlined strategy for delivery of Xpert testing in real-world settings. Twenty health centers with TB microscopy units were selected to participate in the trial, with ten health centers randomized to the intervention strategy (onsite molecular testing using GeneXpert Edge, process redesign to facilitate same-day TB diagnosis and treatment, and performance feedback) or routine care (onsite sputum smear microscopy plus referral of sputum samples to Xpert testing sites). The primary outcome is the number of patients with microbiologically confirmed TB who were initiated on treatment within 14 days of presentation to the health center, which reflects successful completion of the TB diagnostic evaluation process. Secondary outcomes include health outcomes (6-month vital status), as well as measures of the reach, adoption, and implementation of the intervention strategy.DiscussionThe design elements and implementation approach for the XPEL-TB trial were intentionally selected to minimize disruptions to routine care procedures, with the goal of limiting their influence on key primary and secondary outcomes. Trial findings may result in increased support and funding for rapid, onsite molecular testing as the standard-of-care for all patients being evaluated for TB.Trial registrationUS National Institutes of Health's ClinicalTrials.gov, NCT03044158

BackgroundAntiretroviral therapy (ART) for HIV, taken daily, is an effective strategy to clinically suppress the virus, providing the dual benefit of improved survival and vastly decreasing the risk of transmission. However, this highly effective intervention has not yet reached all who could benefit. Cash transfers are increasingly recognized as an effective strategy to motivate behavior change and improve HIV care and treatment outcomes, including engagement in HIV care and adherence to ART. Despite a growing evidence base and strong theoretical foundation for the cash transfer approach, key questions remain. To address these questions and begin to bridge the "know-do gap" with respect to cash transfers, our team is employing an implementation science approach to iterative development of an incentive-based intervention to promote ART uptake and adherence among people living with HIV (PLHIV) in the Lake Zone region, Tanzania.MethodsWe will conduct a type I hybrid implementation-effectiveness trial to test the effectiveness of a cash transfer intervention on the outcome of HIV viral suppression, and concurrently examine the potential for real-world implementation with a mobile health technology (mHealth) system. Specifically, our team will expand the intervention to 32 clinics and enroll 1984 PLHIV to (a) evaluate its effectiveness by conducting a cluster randomized controlled trial with clinics as the unit of randomization and 12-month viral suppression as the primary outcome and (b) evaluate the implementation challenges and successes at multiple levels (patient, provider, clinic).DiscussionThis trial will provide evidence not only about the real-world effectiveness of cash transfers for retention in HIV care and viral suppression, but also on the implementation challenges and successes that will facilitate or hinder wider scale-up within Tanzania and beyond.Trial registrationClinicalTrials.gov NCT04201353 . Registered on December 17, 2019.

BACKGROUND: Universal tobacco-prevention programs targeting youths usually involve significant adults, who are assumed to be important social influences. Commitment not to use tobacco, or to quit use, as a formal contract between an adolescent and a significant adult is a preventive model that has not been widely practiced or explored and has been formally evaluated even less. In this paper, we present the rationale and protocol for the evaluation of the Swedish Tobacco-free Duo program, a multicomponent school-based program the core of which rests on a formal agreement between an adolescent and an adult. The adolescent's commitment mainly concerns avoiding the onset of any tobacco use while the adult commits to support the adolescent in staying tobacco free, being a role model by not using tobacco themselves. OBJECTIVE: To assess (1) whether Tobacco-free Duo is superior to an education-only program in preventing smoking onset among adolescents and promoting cessation among their parents, (2) whether exposure to core components (adult-child agreement) entails more positive effects than exposure to other components, (3) the impact of the program on whole school tobacco use, (4) potential negative side effects, and (5) school-level factors related to fidelity of the program's implementation. METHODS: A mixed-design approach was developed. First, a cluster randomized controlled trial was designed with schools randomly assigned to either the comprehensive multicomponent program or its educational component only. Primary outcome at the adolescent level was identified as not having tried tobacco during the 3-year junior high school compulsory grades (12-15 years of age). An intention-to-treat cohort-wise approach and an as-treated approach complemented with a whole school repeated cross-sectional approach was devised as analytical methods of the trial data. Second, an observational study was added in order to compare smoking incidence in the schools participating in the e

BACKGROUND: Universal tobacco-prevention programs targeting youths usually involve significant adults, who are assumed to be important social influences. Commitment not to use tobacco, or to quit use, as a formal contract between an adolescent and a significant adult is a preventive model that has not been widely practiced or explored and has been formally evaluated even less. In this paper, we present the rationale and protocol for the evaluation of the Swedish Tobacco-free Duo program, a multicomponent school-based program the core of which rests on a formal agreement between an adolescent and an adult. The adolescent's commitment mainly concerns avoiding the onset of any tobacco use while the adult commits to support the adolescent in staying tobacco free, being a role model by not using tobacco themselves. OBJECTIVE: To assess (1) whether Tobacco-free Duo is superior to an education-only program in preventing smoking onset among adolescents and promoting cessation among their parents, (2) whether exposure to core components (adult-child agreement) entails more positive effects than exposure to other components, (3) the impact of the program on whole school tobacco use, (4) potential negative side effects, and (5) school-level factors related to fidelity of the program's implementation. METHODS: A mixed-design approach was developed. First, a cluster randomized controlled trial was designed with schools randomly assigned to either the comprehensive multicomponent program or its educational component only. Primary outcome at the adolescent level was identified as not having tried tobacco during the 3-year junior high school compulsory grades (12-15 years of age). An intention-to-treat cohort-wise approach and an as-treated approach complemented with a whole school repeated cross-sectional approach was devised as analytical methods of the trial data. Second, an observational study was added in order to compare smoking incidence in the schools participating in the e

IntroductionCommunity health workers (CHWs)-shown to improve access to care and reduce maternal, newborn, and child morbidity and mortality-are re-emerging as a key strategy to achieve health-related Sustainable Development Goals (SDGs). However, recent evaluations of national programmes for CHW-led integrated community case management (iCCM) of common childhood illnesses have not found benefits on access to care and child mortality. Developing innovative ways to maximise the potential benefits of iCCM is critical to achieving the SDGs.Methods and analysisAn unblinded, cluster randomised controlled trial in rural Mali aims to test the efficacy of the addition of door-to-door proactive case detection by CHWs compared with a conventional approach to iCCM service delivery in reducing under-five mortality. In the intervention arm, 69 village clusters will have CHWs who conduct daily proactive case-finding home visits and deliver doorstep counsel, care, referral and follow-up. In the control arm, 68 village clusters will have CHWs who provide the same services exclusively out of a fixed community health site. A baseline population census will be conducted of all people living in the study area. All women of reproductive age will be enrolled in the study and surveyed at baseline, 12, 24 and 36 months. The survey includes a life table tracking all live births and deaths occurring prior to enrolment through the 36 months of follow-up in order to measure the primary endpoint: under-five mortality, measured as deaths among children under 5 years of age per 1000 person-years at risk of mortality.Ethics and disseminationThe trial has received ethical approval from the Ethics Committee of the Faculty of Medicine, Pharmacy and Dentistry, University of Bamako. The results will be disseminated through peer-reviewed publications, national and international conferences and workshops, and media outlets.Trial registration numberNCT02694055; Pre-results.

BACKGROUND Health system strengthening is needed to improve delivery of secondary prophylaxis against rheumatic heart disease. METHODS AND RESULTS We undertook a stepped-wedge, randomized trial in northern Australia. Five pairs of Indigenous community clinics entered the study at 3-month steps. Study phases comprised a 12 month baseline phase, 3 month transition phase, 12 month intensive phase and a 3- to 12-month maintenance phase. Clinics received a multicomponent intervention supporting activities to improve penicillin delivery, aligned with the chronic care model, with continuous quality-improvement feedback on adherence. The primary outcome was the proportion receiving ≥80% of scheduled penicillin injections. Secondary outcomes included "days at risk" of acute rheumatic fever recurrence related to late penicillin and acute rheumatic fever recurrence rates. Overall, 304 patients requiring prophylaxis were eligible. The proportion receiving ≥80% of scheduled injections during baseline was 141 of 304 (46%)-higher than anticipated. No effect attributable to the study was evident: in the intensive phase, 126 of 304 (41%) received ≥80% of scheduled injections (odds ratio compared with baseline: 0.78; 95% confidence interval, 0.54-1.11). There was modest improvement in the maintenance phase among high-adhering patients (43% received ≥90% of injections versus 30% [baseline] and 28% [intensive], P<0.001). Also, the proportion of days at risk in the whole cohort decreased in the maintenance phase (0.28 versus 0.32 [baseline] and 0.34 [intensive], P=0.001). Acute rheumatic fever recurrence rates did not differ between study sites during the intensive phase and the whole jurisdiction (3.0 versus 3.5 recurrences per 100 patient-years, P=0.65). CONCLUSIONS This strategy did not improve adherence to rheumatic heart disease secondary prophylaxis within the study time frame. Longer term primary care strengthening strategies are needed. CLINICAL TRIAL REGISTRATION URL: www.anzct

Background: Acute malnutrition is a continuum condition, but severe and moderate forms are treated separately, with different protocols and therapeutic products, managed by separate United Nations agencies. The Combined Protocol for Acute Malnutrition Study (ComPAS) aims to simplify and unify the treatment of uncomplicated severe and moderate acute malnutrition (SAM and MAM) for children 6-59 months into one protocol in order to improve the global coverage, quality, continuity of care and cost-effectiveness of acute malnutrition treatment in resource-constrained settings. Methods/design: This study is a multi-site, cluster randomized non-inferiority trial with 12 clusters in Kenya and 12 clusters in South Sudan. Participants are 3600 children aged 6-59 months with uncomplicated acute malnutrition. This study will evaluate the impact of a simplified and combined protocol for the treatment of SAM and MAM compared to the standard protocol, which is the national treatment protocol in each country. We will assess recovery rate as a primary outcome and coverage, defaulting, death, length of stay, average weekly weight gain and average weekly mid-upper arm circumference (MUAC) gain as secondary outcomes. Recovery rate is defined across both treatment arms as MUAC ≥125 mm and no oedema for two consecutive visits. Per-protocol and intention-to-treat analyses will be conducted. Discussion: If the combined protocol is shown to be non-inferior to the standard protocol, updating guidelines to use the combined protocol would eliminate the need for separate products, resources and procedures for MAM treatment. This would likely be more cost-effective, increase availability of services, enable earlier case finding and treatment before deterioration of MAM into SAM, promote better continuity of care and improve community perceptions of the programme.

Background: Acute malnutrition is a continuum condition, but severe and moderate forms are treated separately, with different protocols and therapeutic products, managed by separate United Nations agencies. The Combined Protocol for Acute Malnutrition Study (ComPAS) aims to simplify and unify the treatment of uncomplicated severe and moderate acute malnutrition (SAM and MAM) for children 6-59 months into one protocol in order to improve the global coverage, quality, continuity of care and cost-effectiveness of acute malnutrition treatment in resource-constrained settings. Methods/design: This study is a multi-site, cluster randomized non-inferiority trial with 12 clusters in Kenya and 12 clusters in South Sudan. Participants are 3600 children aged 6-59 months with uncomplicated acute malnutrition. This study will evaluate the impact of a simplified and combined protocol for the treatment of SAM and MAM compared to the standard protocol, which is the national treatment protocol in each country. We will assess recovery rate as a primary outcome and coverage, defaulting, death, length of stay, average weekly weight gain and average weekly mid-upper arm circumference (MUAC) gain as secondary outcomes. Recovery rate is defined across both treatment arms as MUAC ≥125 mm and no oedema for two consecutive visits. Per-protocol and intention-to-treat analyses will be conducted. Discussion: If the combined protocol is shown to be non-inferior to the standard protocol, updating guidelines to use the combined protocol would eliminate the need for separate products, resources and procedures for MAM treatment. This would likely be more cost-effective, increase availability of services, enable earlier case finding and treatment before deterioration of MAM into SAM, promote better continuity of care and improve community perceptions of the programme.

Background: HIV transmission can be decreased substantially by reducing the burden of undiagnosed HIV infection and expanding early and consistent use of antiretroviral therapy (ART). Treatment as prevention (TasP) has been proposed as key to ending the HIV epidemic. To activate TasP in high prevalence countries, like South Africa, communities must be motivated to know their status, engage in care, and remain in care. Community mobilization (CM) has the potential to significantly increase uptake testing, linkage to and retention in care by addressing the primary social barriers to engagement with HIV care-including poor understanding of HIV care; fear and stigma associated with infection, clinic attendance and disclosure; lack of social support; and gender norms that deter men from accessing care. Methods/design: Using a cluster randomized trial design, we are implementing a 3-year-theory-based CM intervention and comparing gains in HIV testing, linkage, and retention in care among individuals residing in 8 intervention communities to that of individuals residing in 7 control communities. Eligible communities include 15 villages within a health and demographic surveillance site (HDSS) in rural Mpumalanga, South Africa, that were not exposed to previous CM efforts. CM activities conducted in the 8 intervention villages map onto six mobilization domains that comprise the key components for community mobilization around HIV prevention. To evaluate the intervention, we will link a clinic-based electronic clinical tracking system in all area clinics to the HDSS longitudinal census data, thus creating an open, population-based cohort with over 30,000 18-49-year-old residents. We will estimate the marginal effect of the intervention on individual outcomes using generalized estimating equations. In addition, we will evaluate CM processes by conducting baseline and endline surveys among a random sample of 1200 community residents at each time point to monitor intervention ex

Background: HIV transmission can be decreased substantially by reducing the burden of undiagnosed HIV infection and expanding early and consistent use of antiretroviral therapy (ART). Treatment as prevention (TasP) has been proposed as key to ending the HIV epidemic. To activate TasP in high prevalence countries, like South Africa, communities must be motivated to know their status, engage in care, and remain in care. Community mobilization (CM) has the potential to significantly increase uptake testing, linkage to and retention in care by addressing the primary social barriers to engagement with HIV care-including poor understanding of HIV care; fear and stigma associated with infection, clinic attendance and disclosure; lack of social support; and gender norms that deter men from accessing care. Methods/design: Using a cluster randomized trial design, we are implementing a 3-year-theory-based CM intervention and comparing gains in HIV testing, linkage, and retention in care among individuals residing in 8 intervention communities to that of individuals residing in 7 control communities. Eligible communities include 15 villages within a health and demographic surveillance site (HDSS) in rural Mpumalanga, South Africa, that were not exposed to previous CM efforts. CM activities conducted in the 8 intervention villages map onto six mobilization domains that comprise the key components for community mobilization around HIV prevention. To evaluate the intervention, we will link a clinic-based electronic clinical tracking system in all area clinics to the HDSS longitudinal census data, thus creating an open, population-based cohort with over 30,000 18-49-year-old residents. We will estimate the marginal effect of the intervention on individual outcomes using generalized estimating equations. In addition, we will evaluate CM processes by conducting baseline and endline surveys among a random sample of 1200 community residents at each time point to monitor intervention ex

Background: HIV transmission can be decreased substantially by reducing the burden of undiagnosed HIV infection and expanding early and consistent use of antiretroviral therapy (ART). Treatment as prevention (TasP) has been proposed as key to ending the HIV epidemic. To activate TasP in high prevalence countries, like South Africa, communities must be motivated to know their status, engage in care, and remain in care. Community mobilization (CM) has the potential to significantly increase uptake testing, linkage to and retention in care by addressing the primary social barriers to engagement with HIV care-including poor understanding of HIV care; fear and stigma associated with infection, clinic attendance and disclosure; lack of social support; and gender norms that deter men from accessing care. Methods/design: Using a cluster randomized trial design, we are implementing a 3-year-theory-based CM intervention and comparing gains in HIV testing, linkage, and retention in care among individuals residing in 8 intervention communities to that of individuals residing in 7 control communities. Eligible communities include 15 villages within a health and demographic surveillance site (HDSS) in rural Mpumalanga, South Africa, that were not exposed to previous CM efforts. CM activities conducted in the 8 intervention villages map onto six mobilization domains that comprise the key components for community mobilization around HIV prevention. To evaluate the intervention, we will link a clinic-based electronic clinical tracking system in all area clinics to the HDSS longitudinal census data, thus creating an open, population-based cohort with over 30,000 18-49-year-old residents. We will estimate the marginal effect of the intervention on individual outcomes using generalized estimating equations. In addition, we will evaluate CM processes by conducting baseline and endline surveys among a random sample of 1200 community residents at each time point to monitor intervention ex

ObjectiveTo evaluate whether race or ethnicity was independently associated with parental refusal of consent for their child's participation in a multisite pediatric critical care clinical trial.Study designWe performed a secondary analyses of data from Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a 31-center cluster randomized trial of sedation management in critically ill children with acute respiratory failure supported on mechanical ventilation. Multivariable logistic regression modeling estimated associations between patient race and ethnicity and parental refusal of study consent.ResultAmong the 3438 children meeting enrollment criteria and approached for consent, 2954 had documented race/ethnicity of non-Hispanic White (White), non-Hispanic Black (Black), or Hispanic of any race. Inability to approach for consent was more common for parents of Black (19.5%) compared with White (11.7%) or Hispanic children (13.2%). Among those offered consent, parents of Black (29.5%) and Hispanic children (25.9%) more frequently refused consent than parents of White children (18.2%, P < .0167 for each). Compared with parents of White children, parents of Black (OR 2.15, 95% CI 1.56-2.95, P < .001) and Hispanic (OR 1.44, 95% CI 1.10-1.88, P = .01) children were more likely to refuse consent. Parents of children offered participation in the intervention arm were more likely to refuse consent than parents in the control arm (OR 2.15, 95% CI 1.37-3.36, P < .001).ConclusionsParents of Black and Hispanic children were less likely to be approached for, and more frequently declined consent for, their child's participation in a multisite critical care clinical trial. Ameliorating this racial disparity may improve the validity and generalizability of study findings.Trial registrationClinicalTrials.gov: NCT00814099.

ObjectiveTo evaluate whether race or ethnicity was independently associated with parental refusal of consent for their child's participation in a multisite pediatric critical care clinical trial.Study designWe performed a secondary analyses of data from Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a 31-center cluster randomized trial of sedation management in critically ill children with acute respiratory failure supported on mechanical ventilation. Multivariable logistic regression modeling estimated associations between patient race and ethnicity and parental refusal of study consent.ResultAmong the 3438 children meeting enrollment criteria and approached for consent, 2954 had documented race/ethnicity of non-Hispanic White (White), non-Hispanic Black (Black), or Hispanic of any race. Inability to approach for consent was more common for parents of Black (19.5%) compared with White (11.7%) or Hispanic children (13.2%). Among those offered consent, parents of Black (29.5%) and Hispanic children (25.9%) more frequently refused consent than parents of White children (18.2%, P < .0167 for each). Compared with parents of White children, parents of Black (OR 2.15, 95% CI 1.56-2.95, P < .001) and Hispanic (OR 1.44, 95% CI 1.10-1.88, P = .01) children were more likely to refuse consent. Parents of children offered participation in the intervention arm were more likely to refuse consent than parents in the control arm (OR 2.15, 95% CI 1.37-3.36, P < .001).ConclusionsParents of Black and Hispanic children were less likely to be approached for, and more frequently declined consent for, their child's participation in a multisite critical care clinical trial. Ameliorating this racial disparity may improve the validity and generalizability of study findings.Trial registrationClinicalTrials.gov: NCT00814099.

The ‘stepped-wedge cluster randomised trial’ (SW-CRT) harbours promise when for ethical or practical reasons the recruitment of a control group is not possible or when a staggered implementation of an intervention is required. Yet SW-CRT designs can create considerable challenges in terms of methodological integration, implementation, and analysis. While cross-sectional methods in participants recruitment of the SW-CRT have been discussed in the literature the cohort method is a novel feature that has not been considered yet. This paper provides a succinct overview of the methodological, analytical, and practical aspects of cohort SW-CRTs. We discuss five issues that are of special relevance to SW-CRTs. First, issues relating to the design, secondly size of clusters and sample size; thirdly, dealing with missing data in the fourth place analysis; and finally, the advantages and disadvantages of SW-CRTs are considered. An Australian study employing a cohort SW-CRT to evaluate a domiciliary aged care intervention is used as case study. The paper concludes that the main advantage of the cohort SW-CRT is that the intervention rolls out to all participants. There are concerns about missing a whole cluster, and difficulty of completing clusters in a given time frame due to involvement frail older people. Cohort SW-CRT designs can be successfully used within public health and health promotion context. However, careful planning is required to accommodate methodological, analytical, and practical challenges.

Background: HIV transmission can be decreased substantially by reducing the burden of undiagnosed HIV infection and expanding early and consistent use of antiretroviral therapy (ART). Treatment as prevention (TasP) has been proposed as key to ending the HIV epidemic. To activate TasP in high prevalence countries, like South Africa, communities must be motivated to know their status, engage in care, and remain in care. Community mobilization (CM) has the potential to significantly increase uptake testing, linkage to and retention in care by addressing the primary social barriers to engagement with HIV care-including poor understanding of HIV care; fear and stigma associated with infection, clinic attendance and disclosure; lack of social support; and gender norms that deter men from accessing care. Methods/design: Using a cluster randomized trial design, we are implementing a 3-year-theory-based CM intervention and comparing gains in HIV testing, linkage, and retention in care among individuals residing in 8 intervention communities to that of individuals residing in 7 control communities. Eligible communities include 15 villages within a health and demographic surveillance site (HDSS) in rural Mpumalanga, South Africa, that were not exposed to previous CM efforts. CM activities conducted in the 8 intervention villages map onto six mobilization domains that comprise the key components for community mobilization around HIV prevention. To evaluate the intervention, we will link a clinic-based electronic clinical tracking system in all area clinics to the HDSS longitudinal census data, thus creating an open, population-based cohort with over 30,000 18-49-year-old residents. We will estimate the marginal effect of the intervention on individual outcomes using generalized estimating equations. In addition, we will evaluate CM processes by conducting baseline and endline surveys among a random sample of 1200 community residents at each time point to monitor intervention ex

Background: HIV transmission can be decreased substantially by reducing the burden of undiagnosed HIV infection and expanding early and consistent use of antiretroviral therapy (ART). Treatment as prevention (TasP) has been proposed as key to ending the HIV epidemic. To activate TasP in high prevalence countries, like South Africa, communities must be motivated to know their status, engage in care, and remain in care. Community mobilization (CM) has the potential to significantly increase uptake testing, linkage to and retention in care by addressing the primary social barriers to engagement with HIV care-including poor understanding of HIV care; fear and stigma associated with infection, clinic attendance and disclosure; lack of social support; and gender norms that deter men from accessing care. Methods/design: Using a cluster randomized trial design, we are implementing a 3-year-theory-based CM intervention and comparing gains in HIV testing, linkage, and retention in care among individuals residing in 8 intervention communities to that of individuals residing in 7 control communities. Eligible communities include 15 villages within a health and demographic surveillance site (HDSS) in rural Mpumalanga, South Africa, that were not exposed to previous CM efforts. CM activities conducted in the 8 intervention villages map onto six mobilization domains that comprise the key components for community mobilization around HIV prevention. To evaluate the intervention, we will link a clinic-based electronic clinical tracking system in all area clinics to the HDSS longitudinal census data, thus creating an open, population-based cohort with over 30,000 18-49-year-old residents. We will estimate the marginal effect of the intervention on individual outcomes using generalized estimating equations. In addition, we will evaluate CM processes by conducting baseline and endline surveys among a random sample of 1200 community residents at each time point to monitor intervention ex

OBJECTIVE: We identify complexities encountered, including unanticipated crossover between trial arms and inadequate 'standard of care' violence services, during a cluster randomized trial (CRT) of a community-level intimate partner violence (IPV) and HIV prevention intervention in Uganda. METHODS: Concepts in public health ethics - beneficence, social value of research, fairness, standard of care, and researcher responsibilities for post-trial benefits - are used to critically reflect on lessons learned and guide discussion on practical and ethical challenges of violence intervention CRTs. RESULTS: Existing ethical guidelines provide incomplete guidance for responding to unexpected crossover in CRTs providing IPV services. We struggled to balance duty of care with upholding trial integrity, and identifying and providing appropriate standard of care. While we ultimately offered short-term IPV services to controls, we faced additional challenges related to sustaining services beyond the 'short-term' and post-trial. CONCLUSION: Studies evaluating community-level violence interventions, including those combined with HIV reduction strategies, are limited yet critical for developing evidence-based approaches for effectively preventing IPV. Although CRTs are a promising design, further guidance is needed to implement trials that avoid introducing tensions between validity of findings, researchers' responsibilities to protect participants, and equitable distribution of CRT benefits.

ObjectiveWe identify complexities encountered, including unanticipated crossover between trial arms and inadequate 'standard of care' violence services, during a cluster randomized trial (CRT) of a community-level intimate partner violence (IPV) and HIV prevention intervention in Uganda.MethodsConcepts in public health ethics - beneficence, social value of research, fairness, standard of care, and researcher responsibilities for post-trial benefits - are used to critically reflect on lessons learned and guide discussion on practical and ethical challenges of violence intervention CRTs.ResultsExisting ethical guidelines provide incomplete guidance for responding to unexpected crossover in CRTs providing IPV services. We struggled to balance duty of care with upholding trial integrity, and identifying and providing appropriate standard of care. While we ultimately offered short-term IPV services to controls, we faced additional challenges related to sustaining services beyond the 'short-term' and post-trial.ConclusionStudies evaluating community-level violence interventions, including those combined with HIV reduction strategies, are limited yet critical for developing evidence-based approaches for effectively preventing IPV. Although CRTs are a promising design, further guidance is needed to implement trials that avoid introducing tensions between validity of findings, researchers' responsibilities to protect participants, and equitable distribution of CRT benefits.

In cluster randomized trials (CRTs), groups are randomized to treatment arms rather than individuals while the outcome is assessed on the individuals within each cluster. Individuals within clusters tend to be more similar than in a randomly selected sample, which poses issues with dependence, which may lead to underestimated standard errors if ignored. To adjust for the correlation between individuals within clusters, two main approaches are used to analyze CRTs: cluster-level and individual-level analysis. In a cluster-level analysis summary measures are obtained for each cluster and then the two sets of cluster-specific measures are compared, such as with a t-test of the cluster means. A mixed model which takes into account cluster membership is an example of an individual-level analysis. We used a simulation study to quantify and compare power and bias of these two methods. We further take into account the effect of missing data. Complete datasets were generated and then data were deleted to simulate missing completely at random (MCAR) and missing at random (MAR) data. A balanced design, with two treatment groups and two time points was assumed. Cluster size, variance components (including within-subject, within-cluster and between-cluster variance) and proportion of missingness were varied to simulate common scenarios seen in practice. For each combination of parameters, 1,000 datasets were generated and analyzed. Results of our simulation study indicate that cluster-level analysis resulted in substantial loss of power when data were MAR. Individual-level analysis had higher power and remained unbiased, even with a small number of clusters.

BACKGROUND: Osteoporosis is a debilitating disease. Adequate calcium consumption and physical activity are the two major modifiable risk factors. This paper describes the major outcomes and efficacy of a workplace-based targeted behaviour change intervention to improve the dietary and physical activity behaviours of working women in sedentary occupations in Singapore. METHODS: A cluster-randomized design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the units of randomization and intervention. Sixteen workplaces were recruited from a pool of 97, and randomly assigned to intervention and control arms (eight workplaces in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organization-wide educational activities. Workplaces in the control/standard care arm received print resources. Outcome measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, 4 weeks and 6 months post intervention. Adjusted cluster-level analyses were conducted comparing changes in intervention versus control groups, following intention-to-treat principles and CONSORT guidelines. RESULTS: Workplaces in the intervention group reported a significantly greater increase in calcium intake and duration of load-bearing moderate to vigorous physical activity (MVPA) compared with the standard care control group. Four weeks after intervention, the difference in adjusted mean calcium intake was 343.2 mg/day (95 % CI = 337.4 to 349.0, p < .0005) and the difference in adjusted mean load-bearing MVPA was 55.6 min/week (95 % CI = 54.5 to 56.6, p < .0005). Six months post intervention, the mean differences attenuated slightly to 290.5 mg/day (95 % CI = 28

OBJECTIVE: We identify complexities encountered, including unanticipated crossover between trial arms and inadequate 'standard of care' violence services, during a cluster randomized trial (CRT) of a community-level intimate partner violence (IPV) and HIV prevention intervention in Uganda. METHODS: Concepts in public health ethics - beneficence, social value of research, fairness, standard of care, and researcher responsibilities for post-trial benefits - are used to critically reflect on lessons learned and guide discussion on practical and ethical challenges of violence intervention CRTs. RESULTS: Existing ethical guidelines provide incomplete guidance for responding to unexpected crossover in CRTs providing IPV services. We struggled to balance duty of care with upholding trial integrity, and identifying and providing appropriate standard of care. While we ultimately offered short-term IPV services to controls, we faced additional challenges related to sustaining services beyond the 'short-term' and post-trial. CONCLUSION: Studies evaluating community-level violence interventions, including those combined with HIV reduction strategies, are limited yet critical for developing evidence-based approaches for effectively preventing IPV. Although CRTs are a promising design, further guidance is needed to implement trials that avoid introducing tensions between validity of findings, researchers' responsibilities to protect participants, and equitable distribution of CRT benefits.

ObjectiveWe identify complexities encountered, including unanticipated crossover between trial arms and inadequate 'standard of care' violence services, during a cluster randomized trial (CRT) of a community-level intimate partner violence (IPV) and HIV prevention intervention in Uganda.MethodsConcepts in public health ethics - beneficence, social value of research, fairness, standard of care, and researcher responsibilities for post-trial benefits - are used to critically reflect on lessons learned and guide discussion on practical and ethical challenges of violence intervention CRTs.ResultsExisting ethical guidelines provide incomplete guidance for responding to unexpected crossover in CRTs providing IPV services. We struggled to balance duty of care with upholding trial integrity, and identifying and providing appropriate standard of care. While we ultimately offered short-term IPV services to controls, we faced additional challenges related to sustaining services beyond the 'short-term' and post-trial.ConclusionStudies evaluating community-level violence interventions, including those combined with HIV reduction strategies, are limited yet critical for developing evidence-based approaches for effectively preventing IPV. Although CRTs are a promising design, further guidance is needed to implement trials that avoid introducing tensions between validity of findings, researchers' responsibilities to protect participants, and equitable distribution of CRT benefits.

In cluster randomized trials (CRTs), groups are randomized to treatment arms rather than individuals while the outcome is assessed on the individuals within each cluster. Individuals within clusters tend to be more similar than in a randomly selected sample, which poses issues with dependence, which may lead to underestimated standard errors if ignored. To adjust for the correlation between individuals within clusters, two main approaches are used to analyze CRTs: cluster-level and individual-level analysis. In a cluster-level analysis summary measures are obtained for each cluster and then the two sets of cluster-specific measures are compared, such as with a t-test of the cluster means. A mixed model which takes into account cluster membership is an example of an individual-level analysis. We used a simulation study to quantify and compare power and bias of these two methods. We further take into account the effect of missing data. Complete datasets were generated and then data were deleted to simulate missing completely at random (MCAR) and missing at random (MAR) data. A balanced design, with two treatment groups and two time points was assumed. Cluster size, variance components (including within-subject, within-cluster and between-cluster variance) and proportion of missingness were varied to simulate common scenarios seen in practice. For each combination of parameters, 1,000 datasets were generated and analyzed. Results of our simulation study indicate that cluster-level analysis resulted in substantial loss of power when data were MAR. Individual-level analysis had higher power and remained unbiased, even with a small number of clusters.

BackgroundUnhealthy alcohol use is a major contributor to the global burden of disease and injury. The US Preventive Services Task Force has recommended alcohol screening and intervention in general medical settings since 2004. Yet less than one in six US adults report health care professionals discussing alcohol with them. Little is known about methods for increasing implementation; different staffing models may be related to implementation effectiveness. This implementation trial compared delivery of alcohol screening, brief intervention and referral to specialty treatment (SBIRT) by physicians versus non-physician providers receiving training, technical assistance, and feedback reports.MethodsThe study was a cluster randomized implementation trial (ADVISe [Alcohol Drinking as a Vital Sign]). Within a private, integrated health care system, 54 adult primary care clinics were stratified by medical center and randomly assigned in blocked groups of three to SBIRT by physicians (PCP arm) versus non-physician providers and medical assistants (NPP and MA arm), versus usual care (Control arm). NIH-recommended screening questions were added to the electronic health record (EHR) to facilitate SBIRT. We examined screening and brief intervention and referral rates by arm. We also examined patient-, physician-, and system-level factors affecting screening rates and, among those who screened positive, rates of brief intervention and referral to treatment.ResultsScreening rates were highest in the NPP and MA arm (51 %); followed by the PCP arm (9 %) and the Control arm (3.5 %). Screening increased over the 12 months after training in the NPP and MA arm but remained stable in the PCP arm. The PCP arm had higher brief intervention and referral rates (44 %) among patients screening positive than either the NPP and MA arm (3.4 %) or the Control arm (2.7 %). Higher ratio of MAs to physicians was related to higher screening rates in the NPP and MA a

Small sample inference with clustered data has received increased attention recently in the methodological literature with several simulation studies being presented on the small sample behavior of various methods. There are several different classes of methods that can be implemented to account for clustering and disciplinary allegiances are quite rigid: for instance, recent reviews have found that 94% of psychology studies use multilevel models whereas only 3% of economics studies use multilevel models. In economics, fixed effects models are far more popular and in biostatistics there is a tendency to employ generalized estimating equations. As a result of these strong disciplinary preferences, methodological studies tend to focus only a single class of methods (e.g., multilevel models in psychology) while largely ignoring other possible methods. Therefore, the performance of small sample methods have been investigated within classes of methods but studies have not expanded investigations across disciplinary boundaries to more broadly compare the performance of small sample methods that exist in the various classes of methods to accommodate clustered data. Motivated by an applied educational psychology study with a few clusters, in this dissertation the various methods to accommodate clustered data and their small sample extensions are introduced. Then a wide ranging simulation study is conducted to compare 12 methods to model clustered data with a small number of clusters. Many small sample studies generate data from fairly unrealistic models that only feature a single predictor at each level so this study generates data from a more complex model with 8 predictors that is more reminiscent of data researchers might have in an applied study. Few studies have also investigated extremely small numbers of clusters (less than 10) that are quite common in many researchers areas where clusters contain many observations and are there expensive to recruit (e.g., schools, h

The Prevention of Low Back Pain in the Military (POLM) clinical trial has been successfully completed. With the no cost extension year the research team completed all remaining SOW tasks with particular attention paid to the primary data analyses. In the no cost extension year the research team presented data at a national physical therapy conference and 2 manuscripts were accepted for publication in J Ultrasound Med BMC and Musculoskelet Disord. Our primary analyses suggest that the core stabilization exercise approach did not have preventative effects for low back pain. However, the brief psychosocial education approach did have preventative effects by resulting in a 3.3% decrease in low back pain incidence over 2 years (NNT = 30). The analyses for incidence outcomes are in review with Archives Int Med and for severity outcomes with Pain. The completion of the POLM trial provides important evidence that Soldiers may benefit from patient education approaches to reduce incidence of low back pain., The original document contains color images.

Background: Syncope is estimated to account for 1% to 3% of emergency department (ED) annual visits in North America. Although most potential causes of syncope are benign and self-limited, others are associated with serious morbidity and substantial mortality. Recent efforts have focused on prospective identification of ED patients with syncope who are at high risk for early serious adverse outcomes in an attempt to hospitalize them at their first visit to the ED. Objective: The purpose of this thesis is to describe the methodological issues related to the design of a study to determine whether the Revised Strategy of Syncope Diagnosis in the Emergency Room at the General Hospital Structured Care Pathway (RESASTER-SCP) is superior to usual care in identifying patients at low risk for serious adverse outcomes presenting to the ED who can be safely discharged home. Design and Methods: A cluster randomized trial will be conducted with EDs (16 teaching and 46 non-teaching general hospitals) as the unit of randomization and patients presenting with syncope (TLOC) as the unit of analysis. Study participants will be followed at 1, 3, 5, and 12 months after the intervention (RESASTER-SCP vs. usual care) has been applied in the ED. Intention to treat analysis will be used. The analysis will be conducted at the individual level using proportions. Alpha level will be set at 0.05 with a power of 0.80 for the primary outcome. Conclusion: This thesis describes some of the methodological issues concerning the design of a cluster randomized trial to determine whether or not RESASTER-SCP is superior to usual care in identifying patients presenting with syncope to the ED who can be safely discharged home., Master of Science (MSc)

OBJECTIVE - To evaluate whether an electronic reminder integrated into a routine computer system increases the use of antiplatelet drugs for diabetic patients among Italian general practitioners (GPs). RESEARCH DESIGN AND METHODS - A randomized controlled trial was carried out among 300 GPs and their patients selected from the Health Search Database. Among these, 150 GPs (intervention group) received instructions to activate an electronic reminder plus a letter summarizing the beneficial effects of antiplatelet drugs in diabetic patients with at least one additional cardiovascular risk factor ("high risk"), whereas the other 150 GPs (control group) received only the letter. The electronic reminder, integrated into a standard software system for the management of the daily clinical practice, was displayed when every participating GP opened the medical record of diabetic patients aged ≥30 years. Only high-risk diabetic patients were included in the analysis. Patients were considered under antiplatelet treatment if they received two or more prescriptions at baseline and during the follow-up. RESULTS - We selected 15,343 high-risk diabetic patients, 7,313 belonging to GPs of the control group and 8,030 belonging to GPs of the intervention group. Overall, 1,672 patients (22.9%) of the control group and 1,886 (23.5%) patients of the intervention group received antiplatelet drugs at baseline (P = N.S.). At the end of the follow-up, the number of treated patients was significantly increased in the intervention group (odds ratio 1.99, 95% CI 1.79-2.22) versus the control group. The effect of the electronic reminder was more relevant among those patients with one or more cardiovascular risk factors but without previous cardiovascular diseases (CVDs), compared with those with CVDs. CONCLUSIONS - These findings provide evidence for the effect of an electronic reminder in affecting the prescriptive behavior of GPs