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 Barriers to a software reminder system for risk assessment of stroke in atrial fibrillation: a process evaluation of a cluster randomised trial in general practice

2018 ◽  
Vol 68 (677) ◽  
pp. e844-e851
Author(s):  
Tim A Holt ◽  
Andrew RH Dalton ◽  
Susan Kirkpatrick ◽  
Jenny Hislop ◽  
Tom Marshall ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Risk Assessment ◽  
General Practice ◽  
Process Evaluation ◽  
Oral Anticoagulants ◽  
Qualitative Interviews ◽  
Randomised Trial ◽  
Software Tool ◽  
Cluster Randomised Trial ◽  
Cluster Randomised

BackgroundOral anticoagulants reduce the risk of stroke in patients with atrial fibrillation (AF), but are underused. AURAS-AF (AUtomated Risk Assessment for Stroke in AF) is a software tool designed to identify eligible patients and promote discussions within consultations about initiating anticoagulants.AimTo investigate the implementation of the software in UK general practice.Design and settingProcess evaluation involving 23 practices randomly allocated to use AURAS-AF during a cluster randomised trial.MethodAn initial invitation to discuss anticoagulation was followed by screen reminders appearing during consultations until a decision had been made. The reminders required responses, giving reasons for cases where an anticoagulant was not initiated. Qualitative interviews with clinicians and patients explored acceptability and usability.ResultsIn a sample of 476 patients eligible for the invitation letter, only 159 (33.4%) were considered suitable for invitation by their GPs. Reasons given were frequently based on frailty, and risk of falls or haemorrhage. Of those invited, 35 (22%) started an anticoagulant (7.4% of those originally identified). A total of 1695 main-screen reminders occurred in 940 patients. In 883 instances, the decision was taken not to initiate and a range of reasons offered. Interviews with 15 patients and seven clinicians indicated that the intervention was acceptable, though the issue of disruptive screen reminders was raised.ConclusionAutomated risk assessment for stroke in atrial fibrillation and prompting during consultations are feasible and generally acceptable, but did not overcome concerns about frailty and risk of haemorrhage as barriers to anticoagulant uptake.

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 A Police Partnership Targeting Truancy: Study Protocol for a Cluster Randomised Controlled Trial

2020 ◽  
Vol 4 (3-4) ◽  
pp. 134-159
Author(s):  
Lorraine Mazerolle ◽  
Sarah Bennett ◽  
Stephanie M. Cardwell
Keyword(s):  
School Engagement ◽  
Statistical Power ◽  
School Attendance ◽  
Controlled Trial ◽  
Research Question ◽  
Randomised Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Research Question How can an Australian police agency best test its role in a truancy prevention programme that can help to prevent crime? Data Operational and analytic planning for testing the Ability School Engagement Partnership (ASEP) programme in Queensland that aims to increase school attendance and reduce anti-social behaviour, including offending. Methods Fulfilling the requirements for registering a randomised trial protocol with the Clinicaltrials.gov Registry (NCT04281966; date registered 24 February 2020). Findings A protocol deploying a cluster randomised trial offers sufficient statistical power to detect a moderately large effect size as statistically significant with 80% probability. Conclusion Implementation of this protocol as planned would provide an internally valid test of the effectiveness of the ASEP programme in real-world conditions.

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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