Dataset Information

Inconsistency in Diarrhea Measurements when Assessing Intervention Impact in a Non-Blinded Cluster-Randomized Controlled Trial.

ABSTRACT: To explore the consistency in impact evaluation based on reported diarrhea, we compared diarrhea data collected through two different surveys and with observed diarrhea-associated hospitalization for children aged ? 5 years from a non-blinded cluster-randomized trial conducted over 2 years in urban Dhaka. We have previously reported that the interventions did not reduce diarrhea-associated hospitalization for children aged ? 5 years in this trial. We randomly allocated 90 geographic clusters comprising > 60,000 low-income households into three groups: cholera vaccine only, vaccine plus behavior change (cholera vaccine and handwashing plus drinking water chlorination promotion), and control. We calculated reported diarrhea prevalence within the last 2 days using data collected from two different survey methods. The "census" data were collected from each household every 6 months for updating household demographic information. The "monthly survey" data were collected every month from a subset of randomly selected study households for monitoring the uptake of behavior change interventions. We used binomial regression with a logarithmic link accounting for clustering to compare diarrhea prevalence across intervention and control groups separately for both census and monthly survey data. No intervention impact was detected in the census (vaccine only versus control: 2.32% versus 2.53%; P = 0.49; vaccine plus behavior change versus control: 2.44% versus 2.53%; P = 0.78) or in the vaccine only versus control in the monthly survey (3.39% versus 3.80%; P = 0.69). However, diarrhea prevalence was lower in the vaccine-plus-behavior-change group than control in the monthly survey (2.08% versus 3.80%; P = 0.02). Although the reasons for different observed treatment effects in the census and monthly survey data in this study are unclear, these findings emphasize the importance of assessing objective outcomes along with reported outcomes from non-blinded trials.

SUBMITTER: Najnin N

PROVIDER: S-EPMC6609177 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Inconsistency in Diarrhea Measurements when Assessing Intervention Impact in a Non-Blinded Cluster-Randomized Controlled Trial.

Najnin Nusrat N Leder Karin K Forbes Andrew A Unicomb Leanne L Qadri Firdausi F Ram Pavani K PK Winch Peter J PJ Begum Farzana F Biswas Shwapon S Parvin Tahmina T Yeasmin Farzana F Cravioto Alejandro A Luby Stephen P SP

The American journal of tropical medicine and hygiene 20190701 1

To explore the consistency in impact evaluation based on reported diarrhea, we compared diarrhea data collected through two different surveys and with observed diarrhea-associated hospitalization for children aged ≤ 5 years from a non-blinded cluster-randomized trial conducted over 2 years in urban Dhaka. We have previously reported that the interventions did not reduce diarrhea-associated hospitalization for children aged ≤ 5 years in this trial. We randomly allocated 90 geographic clusters com ...[more]

PMID: 31162005

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Project description:PURPOSE: Targeted interventions to reduce the risk and increase the early detection of melanoma have the potential to save lives. We aimed to assess the effect of such an intervention on patient prevention behavior. METHODS: We conducted a pilot clustered randomized controlled trial, comparing a targeted screening and education intervention with a conventional information-based campaign in 20 private surgeries in western France. In the intervention group, 10 general practitioners identified patients at elevated risk for melanoma with a validated assessment tool, the Self-Assessment Melanoma Risk Score (SAMScore), examined their skin, and counseled them using information leaflets. In the control group, 10 general practitioners displayed a poster and the leaflets in their waiting room and examined patients' skin at their own discretion. The main outcome measures were sunbathing and skin self-examinations among patients at elevated risk, assessed 5 months later with a questionnaire. RESULTS: Analyses were based on 173 patients. Compared with control patients, intervention patients were more likely to remember the campaign (81.4% vs 50.0%, P = .0001) and to correctly identify their elevated risk of melanoma (71.1% vs 42.1%, P = .001). Furthermore, intervention patients had higher levels of prevention behaviors: they were less likely to sunbathe in the summer (24.7% vs 40.8%, P = .048) and more likely to have performed skin self-examinations in the past year (52.6% vs 36.8%, P = .029). The intervention was not associated with any clear adverse effects, although there were trends whereby intervention patients were more likely to worry about melanoma and to consult their general practitioner again about the disease. CONCLUSIONS: The combination of use of the SAMScore and general practitioner examination and counseling during consultations is an efficient way to promote patient behaviors that may reduce melanoma risk. Extending the duration of follow-up and demonstrating an impact on morbidity and mortality remain major issues for further research.

Project description:Epidemiological studies have shown that patient transfer is a risk factor for back pain, back injuries and long term sickness absence, whereas consistent use of assistive devices during patient transfer seems to be protective. While classical ergonomic interventions based on education and training in lifting and transferring techniques have not proven to be effective in preventing back pain, participatory ergonomics, that is meant to engage and motivate the involved parties while at the same time making the intervention maximally relevant, may represent a better solution. However, these findings are largely based on uncontrolled studies and thus lack to be confirmed by studies with better study designs. In this article, we present the design of a study which aims to evaluate the effect and process of a participatory organizational intervention for improved use of assistive devices.The study was performed as a cluster randomized controlled trial. We recruited 27 departments (clusters) from five hospitals in Denmark to participate in the study. Prior to randomization, interviews, observations and questionnaire answers (baseline questionnaire) were collected to gain knowledge of barriers and potential solutions for better use of assistive devices. In April 2016, the 27 departments were randomly allocated using a random numbers table to a participatory intervention (14 clusters, 324 healthcare workers) or a control group (13 clusters, 318 healthcare workers). The participatory intervention will consist of workshops with leaders and selected healthcare workers of each department. Workshop participants will be asked to discuss the identified barriers, develop solutions for increasing the use of assistive devices and implement them in their department. Use of assistive devices (using digital counters -, primary outcome, and accelerometers and questionnaire - secondary outcome), perceived physical exertion during patient transfer, pain intensity in the lower back, occurrence of work-related back injuries during patient transfer, organizational readiness to change, knowledge on how to perform proper patient transfer, social capital and work ability (secondary outcomes) were assessed at baseline and will also be assessed at 1 year follow-up. Process evaluation will be based on qualitative and quantitative data to assess the implementation, the change process, and the impact of context aspects.The study will evaluate the effect and process of a participatory intervention on improving the use of assistive devices for patient transfer among hospital healthcare workers. By using cluster-randomization, as well as process- and effect evaluation based on objective measures we will contribute to the evidence base of a promising intervention approach.ClinicalTrials.gov ( NCT02708550 ). March, 2016.

Project description:BACKGROUND:Construction work frequently involves heavy physical work, and a reduction of the physical workload should have high priority. Technological development has made it possible to obtain field measurements with surface electromyography (sEMG), kinematics measured with inertial measurement units (IMUs), and video recordings. However, no studies have used these methods simultaneously to detect situations with excessive physical workload (events) during a working day. Thus, knowledge about these specific events may combat work-related risk factors. Participatory ergonomics (PE) has shown promising results, but whether it can be used as a tool to reduce the physical workload during construction work remains unknown. OBJECTIVE:This cluster randomized controlled trial investigated whether a PE intervention with technical measurements consisting of IMUs, sEMG, heart rate monitoring, and video recordings of physical workload could reduce the number of events with excessive physical workload during a working day. Furthermore, other outcomes were obtained from questionnaires. METHODS:A total of 80 male full-time construction workers (aged 19 to 67 years) were randomized at the cluster level (gang) to a PE intervention consisting of 3 workshops (7 gangs and 32 workers) or to a control group (8 gangs and 48 workers). The physical workload was recorded by technical measurements, that is, IMUs, sEMG, heart rate monitoring, and video recordings during a full working day at baseline and 3 and 6 months' follow-up. On the basis of the technical measurements, a custom-made computer program detected the situations (events) where the construction workers were exposed to excessive physical workload and used in the intervention. Differences in the number of events from baseline to follow-up between intervention and control were evaluated using linear mixed models (intention-to-treat), with individual nested in cluster as a random factor. Furthermore, questionnaires were filled out on test days. RESULTS:The results of the primary outcome showed no change in the number of events with excessive physical workload. However, compared with the control group, the other outcomes showed decreased general fatigue after a typical working day (P=.001) and increased influence on own work (P=.04). CONCLUSIONS:This PE intervention with technical measurements did not reduce the number of events with excessive physical workload during construction work. However, the intervention led to decreased general fatigue and increased influence on own work. TRIAL REGISTRATION:ClinicalTrials.gov NCT02498197; https://clinicaltrials.gov/ct2/show/NCT02498197 (Archived by WebCite at http://www.webcitation.org/74SZ3DIWS).

Project description:We assessed the impact of handwashing promotion on reported respiratory illness as a secondary outcome from among > 60,000 low-income households enrolled in a cluster-randomized trial conducted in Bangladesh. Ninety geographic clusters were randomly allocated into three groups: cholera-vaccine-only; vaccine-plus-behavior-change (handwashing promotion and drinking water chlorination); and control. Data on respiratory illness (fever plus either cough or nasal congestion or breathing difficulty within previous 2 days) and intervention uptake (presence of soap and water at handwashing station) were collected through monthly surveys conducted among a different subset of randomly selected households during the intervention period. We determined respiratory illness prevalence across groups and used log-binomial regression to examine the association between respiratory illness and presence of soap and water in the handwashing station. Results were adjusted for age, gender, wealth, and cluster-randomized design. The vaccine-plus-behavior-change group had more handwashing stations with soap and water present than controls (45% versus 25%; P < 0.001). Reported respiratory illness prevalence was similar across groups (vaccine-plus-behavior-change versus control: 2.8% versus 2.9%; 95% confidence interval [CI]: -0.008, 0.006; P = 0.6; cholera-vaccine-only versus control: 3.0% versus 2.9%; 95% CI: -0.006, 0.009; P = 0.4). Irrespective of intervention assignment, respiratory illness was lower among people who had soap and water present in the handwashing station than among those who did not (risk ratioadjusted: 0.82; 95% CI: 0.69-0.98). With modest uptake of the handwashing intervention, we found no impact of this large-scale intervention on respiratory illness. However, those who actually had a handwashing station with soap and water had less illness. This suggests improving the effectiveness of handwashing promotion in achieving sustained behavior change could result in health benefits.

Project description:BackgroundYouth are using social media regularly and represent a group facing substantial risk for sexually transmitted infection (STI). Although there is evidence that the Internet can be used effectively in supporting healthy sexual behavior, this has not yet extended to social networking sites.PurposeTo determine whether STI prevention messages delivered via Facebook are efficacious in preventing increases in sexual risk behavior at 2 and 6 months.DesignCluster RCT, October 2010-May 2011.Setting/participantsIndividuals (seeds) recruited in multiple settings (online, via newspaper ads and face-to-face) were asked to recruit three friends, who in turn recruited additional friends, extending three waves from the seed. Seeds and waves of friends were considered networks and exposed to either the intervention or control condition.InterventionExposure to Just/Us, a Facebook page developed with youth input, or to control content on 18-24 News, a Facebook page with current events for 2 months.Main outcome measuresCondom use at last sex and proportion of sex acts protected by condoms. Repeated measures of nested data were used to model main effects of exposure to Just/Us and time by treatment interaction.ResultsA total of 1578 participants enrolled, with 14% Latino and 35% African-American; 75% of participants completed at least one study follow-up. Time by treatment effects were observed at 2 months for condom use (intervention 68% vs control 56%, p=0.04) and proportion of sex acts protected by condoms (intervention 63% vs control 57%, p=0.03) where intervention participation reduced the tendency for condom use to decrease over time. No effects were seen at 6 months.ConclusionsSocial networking sites may be venues for efficacious health education interventions. More work is needed to understand what elements of social media are compelling, how network membership influences effects, and whether linking social media to clinical and social services can be beneficial.Trial registrationThis study is registered at www.clinicaltrials.govNCT00725959.

Project description:BACKGROUND:Child care workers are among the lowest paid US workers and experience a wide array of health concerns. The physical and mental demands of their job and the lack of employer-provided health-insurance increase health risks. The Caring and Reaching for Health (CARE) study evaluated a 6-month Healthy Lifestyles intervention targeting child care workers' physical activity (primary outcome), other health behaviors, and their workplace health environment. METHODS:Eligible child care centers, defined as being in operation for at least 2 years and employing at least four staff, were enrolled into CARE's cluster-randomized trial. Centers and their child care staff were randomly assigned to either the Healthy Lifestyles (HL) intervention arm or the Healthy Finances (HF) attention control arm using a block randomization approach. Intervention components were delivered through in-person workshops, center-level displays, informational magazines, director coaching, electronic messaging, and an interactive website. Outcome measures were collected during center visits at baseline and immediately post-intervention by trained data collectors blinded to center arm assignment. Workers' physical activity was assessed with accelerometers, worn for 7 days. Secondary outcome measures included biometric assessments of health and fitness, web-based surveys about health behaviors, and an environmental audit of workplace supports for health. Multi-level linear mixed models assessed worker- and center-level changes in these outcomes. RESULTS:Participants included 553 child care workers representing 56 centers (HL?=?250 staff/28 centers, HF?=?303 staff/28 centers). At 6 months, moderate-to-vigorous physical activity declined slightly in both arms (-?1.3?min/day, 95% CI: -?3.0, 0.3 in HL; -?1.9?min/day, 95% CI: -?3.3, -?0.5 in HF), but there was no significant group by time interaction. Several secondary outcomes for other health behaviors and workplace health environment showed improvements in favor of the intervention arm, yet differences did not remain statistically significant after adjustment for multiple comparisons. CONCLUSIONS:While the Healthy Lifestyles intervention did not improve health behaviors or the workplace health environment, results confirmed the pressing need to focus on the health of child care workers. Future interventions should focus on prevalent health issues (e.g., weight, stress), include both high-tech and high-touch intervention strategies, and address work conditions or other social determinants of health (e.g. wages) as a means of improving the health of these essential workers. TRIAL REGISTRATION:Care2BWell: Worksite Wellness for Child Care (NCT02381938).

Dataset Information

Inconsistency in Diarrhea Measurements when Assessing Intervention Impact in a Non-Blinded Cluster-Randomized Controlled Trial.

Publications

Inconsistency in Diarrhea Measurements when Assessing Intervention Impact in a Non-Blinded Cluster-Randomized Controlled Trial.

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