scholarly journals WASH Upgrades for Health in Amhara (WUHA): study protocol for a cluster-randomised trial in Ethiopia

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e039529
Author(s):  
Dionna M Wittberg ◽  
Solomon Aragie ◽  
Wondyifraw Tadesse ◽  
Jason S Melo ◽  
Kristen Aiemjoy ◽  
...  
Keyword(s):  
San Francisco ◽  
Human Subjects ◽  
Randomised Trial ◽  
Clinical Signs ◽  
Chlamydia Infection ◽  
Secondary Outcome ◽  
Cluster Randomised Trial ◽  
Link Type ◽  
Study Protocols ◽  
Hygiene Promotion

IntroductionFacial hygiene promotion and environmental improvements are central components of the global trachoma elimination strategy despite a lack of experimental evidence supporting the effectiveness of water, sanitation and hygiene (WASH) measures for reducing trachoma transmission. The objective of the WUHA (WASH Upgrades for Health in Amhara) trial is to evaluate if a comprehensive water improvement and hygiene education programme reduces the prevalence of ocular chlamydia infection in rural Africa.Methods and analysisForty study clusters, each of which had received at least annual mass azithromycin distributions for the 7 years prior to the start of the study, are randomised in a 1:1 ratio to the WASH intervention arm or a delayed WASH arm. The WASH package includes a community water point, community-based hygiene promotion workers, household wash stations, household WASH education books, household soap distribution and a primary school hygiene curriculum. Educational activities emphasise face-washing and latrine use. Mass antibiotic distributions are not provided during the first 3 years but are provided annually over the final 4 years of the trial. Annual monitoring visits are conducted in each community. The primary outcome is PCR evidence of ocular chlamydia infection among children aged 0–5 years, measured in a separate random sample of children annually over 7 years. A secondary outcome is improvement of the clinical signs of trachoma between the baseline and final study visits as assessed by conjunctival photography. Laboratory workers and photo-graders are masked to treatment allocation.Ethics and disseminationStudy protocols have been approved by human subjects review boards at the University of California, San Francisco, Emory University, the Ethiopian Food and Drug Authority, and the Ethiopian Ministry of Innovation and Technology. A data safety and monitoring committee oversees the trial. Results will be disseminated through peer-reviewed publications and presentations.Trial registration number(http://www.clinicaltrials.gov): NCT02754583; Pre-results.

scholarly journals Effectiveness of expanding annual mass azithromycin distribution treatment coverage for trachoma in Niger: a cluster randomised trial

2017 ◽  
Vol 102 (5) ◽  
pp. 680-686 ◽  
Author(s):  
Abdou Amza ◽  
Boubacar Kadri ◽  
Beido Nassirou ◽  
Sun Y Cotter ◽  
Nicole E Stoller ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Randomised Trial ◽  
Chlamydia Infection ◽  
Cluster Randomised Trial ◽  
Active Trachoma ◽  
Treatment Coverage ◽  
Significant Difference ◽  
Registration Number ◽  
Rate Of Decline ◽  
Antibiotic Coverage

Background/aimsThe WHO recommends 3–5 years of annual mass azithromycin distribution with at least 80% treatment coverage to districts with active trachoma prevalence over 10% among children. Here, we assess the efficacy of expanding the coverage target to at least 90% for trachoma control in a mesoendemic region of Niger.MethodsTwenty-four communities were randomised to a single day of azithromycin distribution with a coverage target of 80% of the community or up to 4 days of treatment, aiming for greater than 90% coverage. Distributions were annual and individuals above 6 months of age were treated. Children under 5 years of age were monitored for ocular chlamydia infection and active trachoma.ResultsAt baseline, ocular chlamydia prevalence was 20.5% (95% CI 9.8% to 31.2%) in the standard coverage arm and 21.9% (95% CI 11.3% to 32.5%) in the enhanced coverage arm, which reduced to 4.6% (95% CI 0% to 9.5%, p=0.008) and 7.1% (95% CI 2.7% to 11.4%, p<0.001) at 36 months, respectively. There was no significant difference in 36-month ocular chlamydia prevalence between the two arms (p=0.21). There was no difference in the rate of decline in ocular chlamydia between the two arms in a repeated measures model (p=0.80).ConclusionsFor annual mass azithromycin distribution programme to an entire community, there may be no additional benefit of increasing antibiotic coverage above the WHO’s 80% target.Trial registration numberNCT00792922, post-results.

scholarly journals Village-Integrated Eye Worker trial (VIEW): rationale and design of a cluster-randomised trial to prevent corneal ulcers in resource-limited settings

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e021556 ◽  
Author(s):  
Kieran S O’Brien ◽  
Raghunandan Byanju ◽  
Ram Prasad Kandel ◽  
Bimal Poudyal ◽  
Mariya Gautam ◽  
...  
Keyword(s):  
Community Health ◽  
San Francisco ◽  
Negative Binomial ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Corneal Ulceration ◽  
Resource Limited Settings ◽  
Corneal Ulcers ◽  
Cluster Randomised ◽  
Resource Limited

IntroductionCorneal opacity is a leading cause of blindness worldwide. In resource-limited settings, untreated traumatic corneal abrasions may result in infection and ultimately, opacity. Although antimicrobial treatment of corneal ulcers may successfully cure infections, the scarring that accompanies the resolution of infection can still result in visual impairment. Prevention may be the optimal approach for reducing corneal blindness. Studies have employed community health workers to provide prompt administration of antimicrobials after corneal abrasions to prevent infections, but these studies were not designed to determine the effectiveness of such a programme.Methods and analysisThe Village-Integrated Eye Worker trial (VIEW) is a cluster-randomised trial designed to assess the effectiveness of a community health worker intervention to prevent corneal ulcers. Twenty-four Village Development Committees (VDCs) in Nepal were randomised to receive a corneal ulcer prevention programme or to no intervention. Female Community Health Volunteers (FCHVs) in intervention VDCs are trained to diagnose corneal abrasions, provide antimicrobials and to refer participants when needed. An annual census is conducted over 3 years in all study VDCs to assess the incidence of corneal ulceration via corneal photography (primary outcome). Masked outcome assessors grade corneal photographs to determine the presence or absence of incident corneal opacities. The primary analysis is negative binomial regression to compare the incidence of corneal ulceration by study arm.Ethics and disseminationThe University of California San Francisco Committee on Human Research, Nepal Netra Jyoti Sangh and the Nepal Health Research Council have given ethical approval for the trial. The results of this trial will be presented at local and international meetings and submitted to peer-reviewed journals for publication.Trial registration numberNCT01969786; Pre-results.

scholarly journals Effectiveness and cost-utility of a multifaceted eHealth strategy to improve back pain beliefs of patients with non-specific low back pain: a cluster randomised trial

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e030879 ◽  
Author(s):  
Arnela Suman ◽  
Frederieke G. Schaafsma ◽  
Johanna M. van Dongen ◽  
Petra J.M. Elders ◽  
Rachelle Buchbinder ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Randomised Trial ◽  
Intervention Group ◽  
Cost Utility ◽  
Secondary Outcome ◽  
Cluster Randomised Trial ◽  
Low Back ◽  
Pain Beliefs ◽  
Cluster Randomised

ObjectivesTo assess the effectiveness and cost-utility of a multifaceted eHealth strategy compared to usual care in improving patients’ back pain beliefs, and in decreasing disability and absenteeism.DesignStepped-wedge cluster randomised trial with parallel economic evaluation.SettingDutch primary healthcare.ParticipantsPatients diagnosed with non-specific low back pain by their general practitioner or physiotherapist. Patients with serious comorbidities or confirmed pregnancy were excluded. 779 patients were randomised into intervention group (n=331, 59% female; 60.4% completed study) or control group (n=448, 57% female; 77.5% completed study).InterventionsThe intervention consisted of a multifaceted eHealth strategy that included a (mobile) website, digital monthly newsletters, and social media platforms. The website provided information about back pain, practical advice (eg, on self-management), working and returning to work with back pain, exercise tips, and short video messages from healthcare providers and patients providing information and tips. The control consisted of a digital patient information letter. Patients and outcome assessors were blinded to group allocation.Primary and secondary outcome measuresThe primary outcome was back pain beliefs. Secondary outcome measures were disability and absenteeism, and for the preplanned economic evaluation quality of life and societal costs were measured.ResultsThere were no between-group differences in back pain beliefs, disability, or absenteeism. Mean intervention costs were €70— and the societal cost difference was €535—in favour of the intervention group, but no significant cost savings were found. The incremental cost-effectiveness ratio indicated that the intervention dominated usual care and the probability of cost-effectiveness was 0.85 on a willingness-to-pay of €10.000/quality adjusted life year (QALY).ConclusionsA multifaceted eHealth strategy was not effective in improving patients’ back pain beliefs or in decreasing disability and absenteeism, but showed promising cost-utility results based on QALYs.Trial registration numberNTR4329.

scholarly journals Cost-effectiveness of a patient-centred approach to managing multimorbidity in primary care: a pragmatic cluster randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e030110 ◽  
Author(s):  
Joanna Thorn ◽  
Mei-See Man ◽  
Katherine Chaplin ◽  
Peter Bower ◽  
Sara Brookes ◽  
...  
Keyword(s):  
Primary Care ◽  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Randomised Trial ◽  
Mean Difference ◽  
Secondary Outcome ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
The Cost

ObjectivePatients with multiple chronic health conditions are often managed in a disjointed fashion in primary care, with annual review clinic appointments offered separately for each condition. This study aimed to determine the cost-effectiveness of the 3D intervention, which was developed to improve the system of care.DesignEconomic evaluation conducted alongside a pragmatic cluster-randomised trial.SettingGeneral practices in three centres in England and Scotland.Participants797 adults with three or more chronic conditions were randomised to the 3D intervention, while 749 participants were randomised to receive usual care.InterventionThe 3D approach: comprehensive 6-monthly general practitioner consultations, supported by medication reviews and nurse appointments.Primary and secondary outcome measuresThe primary economic evaluation assessed the cost per quality-adjusted life year (QALY) gained from the perspective of the National Health Service (NHS) and personal social services (PSS). Costs were related to changes in a range of secondary outcomes (QALYs accrued by both participants and carers, and deaths) in a cost–consequences analysis from the perspectives of the NHS/PSS, patients/carers and productivity losses.ResultsVery small increases were found in both QALYs (adjusted mean difference 0.007 (−0.009 to 0.023)) and costs (adjusted mean difference £126 (£−739 to £991)) in the intervention arm compared with usual care after 15 months. The incremental cost-effectiveness ratio was £18 499, with a 50.8% chance of being cost-effective at a willingness-to-pay threshold of £20 000 per QALY (55.8% at £30 000 per QALY).ConclusionsThe small differences in costs and outcomes were consistent with chance, and the uncertainty was substantial; therefore, the evidence for the cost-effectiveness of the 3D approach from the NHS/PSS perspective should be considered equivocal.Trial registration numberISCRTN06180958

scholarly journals Validation of the Transition Readiness and Appropriateness Measure (TRAM) for the Managing the Link and Strengthening Transition from Child to Adult Mental Healthcare in Europe (MILESTONE) study

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e033324 ◽  
Author(s):  
Paramala Santosh ◽  
Jatinder Singh ◽  
Laura Adams ◽  
Mathilde Mastroianni ◽  
Natalie Heaney ◽  
...  
Keyword(s):  
Mental Health ◽  
Cohort Study ◽  
Mental Health Services ◽  
Young People ◽  
Health Services ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Transition Readiness ◽  
Link Type ◽  
Cluster Randomised

ObjectiveYoung people moving from child and adolescent mental health services (CAMHS) to adult mental health services (AMHS) are faced with significant challenges. To improve this state of affairs, there needs to be a recognition of the problem and initiatives and an urgent requirement for appropriate tools for measuring readiness and outcomes at the transfer boundary (16–18 years of age in Europe). The objective of this study was to develop and validate the Transition Readiness and Appropriateness Measure (TRAM) for assessing a young person’s readiness for transition, and their outcomes at the transfer boundary.DesignMILESTONE prospective study.SettingEight European Union (EU) countries participating in the EU-funded MILESTONE study.ParticipantsThe first phase (MILESTONE validation study) involved 100 adolescents (pre-transition), young adults (post-transition), parents/carers and both CAMHS and AMHS clinicians. The second phase (MILESTONE cohort study and nested cluster randomised trial) involved over 1000 young people.ResultsThe development of the TRAM began with a literature review on transitioning and a review of important items regarding transition by a panel of 34 mental health experts. A list of 64 items of potential importance were identified, which together comprised the TRAM. The psychometric properties of the different versions of the TRAM were evaluated and showed that the TRAM had good reliability for all versions and low-to-moderate correlations when compared with other established instruments and a well-defined factor structure. The main results of the cohort study with the nested cluster randomised trial are not reported.ConclusionThe TRAM is a reliable instrument for assessing transition readiness and appropriateness. It highlighted the barriers to a successful transition and informed clinicians, identifying areas which clinicians on both sides of the transfer boundary can work on to ease the transition for the young person.Trial registration numberISRCTN83240263 (Registered 23 July 2015), NCT03013595 (Registered 6 January 2017); Pre-results.

scholarly journals Menstrual health intervention and school attendance in Uganda (MENISCUS-2): a pilot intervention study

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e031182 ◽  
Author(s):  
Catherine Kansiime ◽  
Laura Hytti ◽  
Ruth Nalugya ◽  
Kevin Nakuya ◽  
Prossy Namirembe ◽  
...  
Keyword(s):  
Pain Management ◽  
School Attendance ◽  
Qualitative Interviews ◽  
Randomised Trial ◽  
Secondary Outcome ◽  
Cluster Randomised Trial ◽  
Behavioural Intervention ◽  
Cluster Randomised ◽  
Menstrual Health ◽  
Pilot Intervention

ObjectivesAchieving good menstrual health and hygiene (MHH) is a public health challenge and there is little evidence to inform interventions. The aim of this study was to pilot test an intervention to improve MHH and school attendance in Uganda, in preparation for a future cluster-randomised trial.DesignLongitudinal study with pre–post evaluation of a pilot intervention.SettingTwo secondary schools in Entebbe, Uganda.ParticipantsOf the 473 eligible students in secondary 2 (S2) at baseline, 450 (95.1%; 232 girls and 218 boys) consented/assented. 369 students (188 girls; 81.0%; and 181 boys; 83.0%) participated in the endline survey.InterventionThe intervention comprised training teachers to improve delivery of government guidelines for puberty education, training in use of a menstrual kit and pain management, a drama skit, provision of analgesics and improvements to school water and sanitation hygiene facilities.Primary and secondary outcome measuresFeasibility and acceptability of delivering the intervention. Baseline and endline quantitative surveys were conducted, with qualitative interviews conducted at endline. School attendance was assessed using self-completed daily diaries among a nested cohort of 100 female students.ResultsThere were high levels of uptake of the individual and behavioural intervention components (puberty education, drama skit, menstrual hygiene management (MHM) kit and pain management). The proportion of girls reporting anxiety about next period decreased from 58.6% to 34.4%, and reported use of effective pain management increased from 76.4% to 91.4%. Most girls (81.4%) reported improved school toilet facilities, which improved their comfort managing menstruation. The diary data and qualitative data indicated a potential intervention impact on improving menstrual-related school absenteeism.ConclusionsThe pilot study showed that the multicomponent MHM intervention was acceptable and feasible to deliver, and potentially effective in improving menstruation knowledge and management. A cluster-randomised trial is needed to evaluate rigorously the intervention effects on MHM and school attendance.Trial registration numberNCT04064736; Pre-results.

scholarly journals Cluster-randomised trial to test the effect of a behaviour change intervention on toilet use in rural India: results and methodological considerations

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Wolf-Peter Schmidt ◽  
Kavita Chauhan ◽  
Priya Bhavsar ◽  
Sandul Yasobant ◽  
Vaibhav Patwardhan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Behaviour Change ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Post Intervention ◽  
Open Defecation ◽  
Link Type ◽  
Cluster Randomised ◽  
Household Members ◽  
Activity Questionnaire

Abstract Background Effective and scalable behaviour change interventions to increase use of existing toilets in low income settings are under debate. We tested the effect of a novel intervention, the ‘5 Star Toilet’ campaign, on toilet use among households owning a toilet in a rural setting in the Indian state of Gujarat. Methods The intervention included innovative and digitally enabled campaign components delivered over 2 days, promoting the upgrading of existing toilets to achieve use by all household members. The intervention was tested in a cluster randomised trial in 94 villages (47 intervention and 47 control). The primary outcome was the proportion of households with use of toilets by all household members, measured through self- or proxy-reported toilet use. We applied a separate questionnaire tool that masked open defecation questions as a physical activity study, and excluded households surveyed at baseline from the post-intervention survey. We calculated prevalence differences using linear regression with generalised estimating equations. Results The primary study outcome was assessed in 2483 households (1275 intervention and 1208 control). Exposure to the intervention was low. Post-intervention, toilet use was 83.8% in the control and 90.0% in the intervention arm (unadjusted difference + 6.3%, 95%CI 1.1, 11.4, adjusted difference + 5.0%, 95%CI -0.1, 10.1. The physical activity questionnaire was done in 4736 individuals (2483 intervention and 2253 control), and found no evidence for an effect (toilet use 80.7% vs 82.2%, difference + 1.7%, 95%CI -3.2, 6.7). In the intervention arm, toilet use measured with the main questionnaire was higher in those exposed to the campaign compared to the unexposed (+ 7.0%, 95%CI 2.2%, 11.7%), while there was no difference when measured with the physical activity questionnaire (+ 0.9%, 95%CI -3.7%, 5.5%). Process evaluation suggested that insufficient campaign intensity may have contributed to the low impact of the intervention. Conclusion The study highlights the challenge in achieving high intervention intensity in settings where the proportion of the total population that are potential beneficiaries is small. Responder bias may be minimised by masking open defecation questions as a physical activity study. Over-reporting of toilet use may be further reduced by avoiding repeated surveys in the same households. Trial registration The trial was registered on the RIDIE registry (RIDIE-STUDY-ID-5b8568ac80c30, 27-8-2018) and retrospectively on clinicaltrials.gov (NCT04526171, 30-8-2020).

scholarly journals Performance and evaluation in computed tomographic colonography screening: protocol for a cluster randomised trial

2020 ◽  
Author(s):  
Andrew A Plumb ◽  
Anu E Obaro ◽  
Paul Bassett ◽  
Rachel Baldwin-Cleland ◽  
Steve Halligan ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Patient Outcome ◽  
Randomised Trial ◽  
Research Network ◽  
Cluster Randomised Trial ◽  
Computed Tomographic Colonography ◽  
Computed Tomographic ◽  
Link Type ◽  
Cluster Randomised ◽  
The Impact

ABSTRACTBackgroundColorectal cancer (CRC) is a common, important healthcare priority and improving patient outcome relies on early diagnosis. Colonoscopy and computed tomographic colonography (CTC) are commonly-used diagnostic tests. Although colonoscopists are highly regulated and must be accredited, no analogous process exists for CTC. There are currently no universally accepted radiologist performance indicators for CTC, and lack of regulatory oversight may lead to variability in quality and lower neoplasia detection rates. This study aims to determine whether a structured educational training and feedback programme can improve radiologist interpretation accuracy.MethodsNHS England CTC reporting radiologists will be cluster randomised to either an intervention (one-day individualised training and assessment with feedback) or control (assessment with no training or feedback) arm. Each cluster represents radiologists reporting CTC in a single NHS site. Both the intervention and control arm will undertake four CTC assessments at baseline, 1-month (after training; intervention arm or enrolment; control arm), 6- and 12 months to assess their detection of colorectal cancer (CRC) and 6mm+ polyps. The primary outcome will be difference in sensitivity at the 1-month test between arms. Secondary outcomes will include sensitivity at 6 and 12 months and radiologist characteristics associated with improved performance. Multilevel logistic regression will be used to analyse per-polyp and per-case sensitivity. Local ethical and Health Research Authority approval have been obtained.DiscussionLack of infrastructure to ensure that CTC radiologists can report adequately and lack of consensus regarding appropriate quality metrics may lead to variability in performance. Our provision of a structured education programme with feedback will evaluate the impact of individualised training and identify the factors related to improved radiologist performance in CTC reporting. An improvement in performance could lead to increased neoplasia detection and better patient outcome.RegistrationClinical Trials (ClinicalTrials.gov Identifier: NCT02892721); available from: https://clinicaltrials.gov/ct2/show/NCT02892721. NIHR Clinical Research Network (CPMS ID 32293).

scholarly journals ‘Screen and Treat for Anaemia Reduction (STAR)’ strategy: study protocol of a cluster randomised trial in rural Telangana, India

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e052238
Author(s):  
Bharati Kulkarni ◽  
Little Flower Augustine ◽  
Raghu Pullakhandam ◽  
Anju Sinha Pradhan ◽  
Teena Dasi ◽  
...  
Keyword(s):  
Rural Areas ◽  
Randomised Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Cluster Randomised Trial ◽  
Control Group ◽  
Population Mean ◽  
Cluster Randomised ◽  
The Difference ◽  
The Impact

IntroductionCurrent anaemia control programme focusing on prophylactic iron supplementation and facility-based screening with haemoglobin estimation is inadequate to reduce the high prevalence of anaemia in India. This study aims to examine the impact of community level ‘screen and treat’ strategy for increasing population mean haemoglobin and reducing anaemia prevalence in the rural population.Methods and analysisAn open-labelled cluster randomised controlled trial will be conducted in rural areas of Medchal district, Telangana, India. All individuals served by one Accredited Social Health Activist (ASHA) constitute one cluster and will be randomised in the ratio of 1:1 by covariate constrained randomisation. Eligible members aged between 6 months and 50 years (men, women, children and adolescents) will be included in the study. Intervention group will be screened for anaemia using a point of care haemoglobin estimation followed by treatment with iron–folic acid for 3 months. The intervention delivered by the ASHAs will be supported by an electronic decision support system and simplified medication regimen. Educational videos and interactive voice response system will be used to enhance compliance. The control group will continue to receive benefits of ongoing anaemia control programmes but there will be no active intervention by the study team. At 6 months, haemoglobin will be measured in participants from both arms. The primary outcome will be the difference in population mean haemoglobin in two arms and the secondary outcome will be the difference in the anaemia prevalence in two arms among 6–59 months old children. Multilevel models will be used for analysis accounting for data clustering.Ethics and disseminationThe study is approved by the institutional ethics committee of National Institute of Nutrition, Hyderabad. The results will be published in peer-reviewed journals and disseminated to policymakers. Findings will also be shared with study participants and community leaders.Trial registration numberCTRI/2019/01/016918.

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