Protocol of the randomised placebo controlled pilot trial of the management of acute sciatica (SCIATICA): a feasibility study

IntroductionAcute sciatica (symptom duration less than 4 weeks), a major cause of pain and disability, is a common presentation to medical practices and hospital emergency departments. Selective CT fluoroscopy transforaminal epidural steroid injection is often used with the hope of reducing pain and improving function. Recently, there has been interest in using systemic corticosteroids in acute sciatica. However, there is limited evidence to inform management of selective CT fluoroscopy transforaminal epidural steroid in subacute and chronic sciatica and there is no evidence in acute sciatica, even though the practice is widespread. There is also limited evidence for the use of systemic corticosteroids in acute sciatica. Furthermore, the management of selective CT fluoroscopy transforaminal epidural steroid versus systemic steroids has never been directly studied.Methods and analysisSCIATICA is a pilot/feasibility study of patients with acute sciatica designed to evaluate the feasibility of undertaking a blinded four-arm randomised controlled intervention study of (1) selective CT fluoroscopy transforaminal epidural steroid (arm 1), (2) selective CT fluoroscopy transforaminal epidural saline (arm 2), (3) 15 days tapering dose of oral steroids (arm 3) and (4) a sham epidural and oral placebo control (arm 4). This feasibility study is designed to evaluate head-to-head, route versus pharmacology of interventions. The primary outcome measure is the Oswestry Disability Index (ODI) at 3 weeks. Secondary outcome is the ODI at 48 weeks. Other outcomes include numerical rating scale for leg pain, Pain DETECT Questionnaire, quality of life, medication use, rescue procedures or surgery, and adverse events. Results of outcomes from this randomised controlled trial will be used to determine the feasibility, sample size and power calculations for a large multicentre study.Ethics and disseminationThe study has been approved by South Eastern Sydney Local Health District Human Research Ethics Committee (HREC/15/331/POHW/586).Trial registration numberNCT03240783; Pre-results.

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Clinical efficacy of a dry extract of five herbal drugs in acute viral rhinosinusitis

Rhinology Journal ◽

10.4193/rhino12.015 ◽

2012 ◽

Vol 50 (4) ◽

pp. 417-426

Author(s):

R. Jund ◽

M. Mondigler ◽

H. Steindl ◽

H. Stammer ◽

P. Stierna ◽

...

Keyword(s):

Controlled Trial ◽

Symptom Relief ◽

Secondary Outcome ◽

Number Needed To Treat ◽

Symptom Duration ◽

Serious Adverse Events ◽

Dry Extract ◽

End Of Treatment ◽

Bno 1016 ◽

Randomised Controlled

Objective: A herbal drug combination (Dry Extract BNO 1016) has been assessed for efficacy and tolerability in patients with acute viral rhinosinusitis. Methodology: In this randomised, controlled trial patients with symptom duration of up to 3 days, mild to moderate facial pain and a Major Symptom Score (MSS) between 8 and 12 were treated for 15 days with BNO 1016 or placebo (coated tablets administered orally). Primary efficacy endpoint was mean MSS at end of treatment. Secondary outcome measures included treatment response and changes in paranasal sinuses assessed by ultrasonography. Results: Treatment resulted in clinically relevant, significant differences in mean MSS for BNO 1016 versus placebo. BNO 1016 provided symptom relief two days earlier than placebo. The number needed to treat for healing is 8. BNO 1016 was superior regarding responder rates at Day 10 and Day 14 and percentage of patients without signs of acute viral rhinosinusitis assessed by ultrasonography at end of treatment. BNO 1016 was well tolerated; no serious adverse events were reported. Conclusion: The herbal dry extract BNO 1016 is efficacious and well tolerated in patients with acute viral rhinosinusitis. Trial registration: ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT01146860; EudraCT: 2009-016682-28).

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Using personalised avatars as an adjunct to a weight loss management programme: a randomised controlled feasibility study (Preprint)

10.2196/preprints.36275 ◽

2022 ◽

Author(s):

Maria Horne ◽

Maryan Hardy ◽

Trevor Murrells ◽

Hassan Ugail ◽

Andrew Hill

Keyword(s):

Quality Of Life ◽

Weight Loss ◽

Feasibility Study ◽

Self Efficacy ◽

Routine Care ◽

Health Concern ◽

Secondary Outcome ◽

Motivation To Change ◽

Randomised Controlled

BACKGROUND Obesity is a global public health concern. Interventions rely predominantly on managing dietary intake and/or increasing physical activity but sustained adherence to behavioural regimens is often poor. As with all interventions, the lack of sustained motivation, self-efficacy and poor adherence to behavioural regimens are recognized barriers to successful weight loss. Avatar-based interventions have been found to achieve better patient outcomes in the management of chronic conditions by promoting more active engagement and the virtual representations of ‘self’ have been shown to impact real-world behaviour, acting as a catalyst for sustained weight loss behaviour. OBJECTIVE We aimed to evaluate whether a personalised avatar, offered as an adjunct to an established weight loss programme, could increase participant motivation and sustain engagement, optimise service delivery, and improve participant health outcomes. METHODS A feasibility randomised design was used to determine the case for future development and evaluation of avatar-based technology in a randomised controlled trial. Participants were recruited from GP referrals to a 12-week NHS weight improvement programme. The main outcome measure was weight loss. Secondary outcome measures were quality-of-life and self-efficacy. Quantitative data were subjected to descriptive statistical tests and exploratory comparison between intervention and control arms. Feasibility and acceptability were assessed through interviews analysed using the framework approach. HRA ethical approval was granted. RESULTS 10 males (7 intervention; 3 routine care) and 33 females (23 intervention; 10 routine care) were recruited. Initial mean weight of participants was greater in the intervention than routine care arm (126.3 kg vs 122.9 kg); pattern of weight loss was similar across both arms of the study in period T0-T1 but accelerated in period T1-T2 for intervention participants, suggesting that access to the self-resembling avatar may promote greater engagement with weight loss initiatives in the short to medium term. Mean change in weight of participants from T0 to T2 was 4.5kg (95% CI: 2.7-6.3) in routine care arm and 5.3kg (95% CI: 3.9-6.8) in the intervention arm. Quality-of-life and self-efficacy measures demonstrated greater improvement in the intervention arm at both T1 (105.5 routine care; 99.7 intervention arm) and T2 (100.1 routine care; 81.2 intervention arm). 13 participants (11 Female, 2 Male) and two healthcare professionals were interviewed about their experience of using the avatar programme. CONCLUSIONS Overall, participants found using the personalised avatar acceptable and feedback reiterated that seeing a future ‘self’ helped reinforce motivation to change behaviour. This feasibility study demonstrated that avatar-based technology may successfully promote engagement and motivation in weight loss programmes, enabling participants to achieve greater weight loss gains and build self-confidence and belief. CLINICALTRIAL 17953876

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Randomised controlled trial of rhinothermy for treatment of the common cold: a feasibility study

BMJ Open ◽

10.1136/bmjopen-2017-019350 ◽

2018 ◽

Vol 8 (3) ◽

pp. e019350 ◽

Cited By ~ 1

Author(s):

Susanne van de Hei ◽

Steven McKinstry ◽

George Bardsley ◽

Mark Weatherall ◽

Richard Beasley ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Vitamin C ◽

Feasibility Study ◽

Common Cold ◽

Controlled Trial ◽

Secondary Outcome ◽

Pcr Analysis ◽

Control Group ◽

The Common ◽

Randomised Controlled

ObjectiveTo determine the feasibility of a randomised controlled trial (RCT) of rhinothermy for the common cold.DesignOpen label, randomised, controlled feasibility study.SettingSingle-centre research institute in New Zealand recruiting participants from the community.Participants30 adult participants with symptoms of a common cold, presenting within 48 hours of the onset of symptoms.InterventionsParticipants were randomly assigned 2:1 to receive either 35 L/min of 100% humidified air at 41°C via high flow nasal cannulae, 2 hours per day for up to 5 days (rhinothermy), or vitamin C 250 mg daily for 5 days (control).Primary and secondary outcome measuresThe primary outcome was the proportion of screened candidates who were randomised. Secondary outcomes included: proportion of randomised participants who completed the study; modified Jackson scores from randomisation to 10 days after initiation of randomised regimen; time until feeling ‘a lot better’ compared with study entry; time until resolution of symptoms or symptom score at 10 days postrandomisation; proportion of organisms identified by PCR analysis of nasal swabs taken at baseline; the patterns of use of the rhinothermy device; estimated adherence of the control group; and rhinothermy device tolerability.ResultsIn all 30/79 (38%, 95% CI 27% to 50%) of potential participants screened for eligibility were randomised. Rhinothermy was well tolerated, and all randomised participants completed the study (100%, 95% CI 88% to 100%). The reduction from baseline in the modified Jackson score was greater with rhinothermy compared with control at days 2, 3, 4, 5 and 6, with the maximum difference at day 4 (−6.4, 95% CI −9.4 to −3.3). The substantial clinical benefit threshold for modified Jackson score was a 5-unit change.ConclusionsThis study shows that an RCT of rhinothermy compared with low-dose vitamin C in the treatment of the common cold is feasible.Trial registration numberACTRN12616000470493; Results.

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Exercise for people living with frailty and receiving haemodialysis: a mixed-methods randomised controlled feasibility study

BMJ Open ◽

10.1136/bmjopen-2020-041227 ◽

2020 ◽

Vol 10 (11) ◽

pp. e041227

Author(s):

Hannah M L Young ◽

Daniel S March ◽

Patrick J Highton ◽

Matthew P M Graham-Brown ◽

Darren C Churchward ◽

...

Keyword(s):

Mixed Methods ◽

Feasibility Study ◽

Controlled Trial ◽

Exercise Programme ◽

Exercise Group ◽

Moderate Intensity ◽

Secondary Outcome ◽

Link Type ◽

Patient Reported ◽

Randomised Controlled

ObjectivesFrailty is highly prevalent in haemodialysis (HD) patients, leading to poor outcomes. This study aimed to determine whether a randomised controlled trial (RCT) of intradialytic exercise is feasible for frail HD patients, and explore how the intervention may be tailored to their needs.DesignMixed-methods feasibility.Setting and participantsPrevalent adult HD patients of the CYCLE-HD trial with a Clinical Frailty Scale Score of 4–7 (vulnerable to severely frail) were eligible for the feasibility study.InterventionsParticipants in the exercise group undertook 6 months of three times per week, progressive, moderate intensity intradialytic cycling (IDC).OutcomesPrimary outcomes were related to feasibility. Secondary outcomes were falls incidence measured from baseline to 1 year following intervention completion, and exercise capacity, physical function, physical activity and patient-reported outcomes measured at baseline and 6 months. Acceptability of trial procedures and the intervention were explored via diaries and interviews with n=25 frail HD patients who both participated in (n=13, 52%), and declined (n=12, 48%), the trial.Results124 (30%) patients were eligible, and of these 64 (52%) consented with 51 (80%) subsequently completing a baseline assessment. n=24 (71% male; 59±13 years) dialysed during shifts randomly assigned to exercise and n=27 (81% male; 65±11 years) shifts assigned to usual care. n=6 (12%) were lost to follow-up. The exercise group completed 74% of sessions. 27%–89% of secondary outcome data were missing. Frail HD patients outlined several ways to enhance trial procedures. Maintaining ability to undertake activities of daily living and social participation were outcomes of primary importance. Participants desired a varied exercise programme.ConclusionsA definitive RCT is feasible, however a comprehensive exercise programme may be more efficacious than IDC in this population.Trial registration numbersISRCTN11299707; ISRCTN12840463.

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Metformin reduces 12-month change in body weight among people newly commenced on clozapine: a retrospective naturalistic cohort study

Therapeutic Advances in Psychopharmacology ◽

10.1177/20451253211000609 ◽

2021 ◽

Vol 11 ◽

pp. 204512532110006

Author(s):

Jessica Spokes ◽

Samantha Hollingworth ◽

Karl Winckel ◽

Steve Kisely ◽

Andrea Baker ◽

...

Keyword(s):

Cohort Study ◽

Weight Gain ◽

Tobacco Smoking ◽

Digital Health ◽

Controlled Trial ◽

Bodyweight Gain ◽

Metabolic Effects ◽

Secondary Outcome ◽

Standard Clinical Practice ◽

Randomised Controlled

Background: People with schizophrenia have a 15–20-year reduction in life expectancy, driven in part by the metabolic effects of antipsychotics. Clozapine is associated with the highest rates of weight gain. As clozapine remains the most effective antipsychotic for treatment-resistant schizophrenia (TRS), identifying treatments to ameliorate clozapine-induced weight gain (CIWG) is urgently needed to reduce this morality gap. Methods: We retrospectively analysed digital health records of patients with TRS aged 18–65 newly initiated on clozapine at four tertiary hospitals in south-east Queensland from 1 March 2017 to 30 June 2019. Our primary outcome was the effect of metformin on change in percentage bodyweight at 12 months after clozapine initiation, with secondary outcome being proportion with >5% or >7% bodyweight change. We also explored impact on bodyweight change of other variables including sex, tobacco smoking, type 2 diabetes (T2DM), age, clozapine level and dose and clozapine/norclozapine ratio. Results: Among 90 patients initiated on clozapine, metformin use ( n = 48) was associated with a smaller increase in percentage bodyweight (1.32% versus 5.95%, p = 0.031), lower rates of >7% gain in bodyweight (37.8% versus 63.0%, p = 0.025) but not >5% gain in bodyweight. Age below the median (32.0 years) was associated with greater bodyweight gain (5.55% versus 1.22%, p = 0.046). Sex, tobacco smoking, T2DM, clozapine dose and level and clozapine/norclozapine ratio were not associated with differences in change in bodyweight. Conclusion: In this small retrospective cohort study, use of metformin within 12-months of clozapine initiation was associated with a statistically and clinically significant reduction in CIWG. Although there is increasing evidence for the role of metformin to ameliorate bodyweight gain at time of clozapine initiation, our findings need replication and testing in a randomised controlled trial before recommending metformin co-commencement with clozapine as standard clinical practice.

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O26 Testing an intervention to reduce fatigue impact in inflammatory arthritis: design and outcomes of a single-arm feasibility study

Rheumatology ◽

10.1093/rheumatology/keab246.025 ◽

2021 ◽

Vol 60 (Supplement_1) ◽

Author(s):

Susan Bridgewater ◽

Joe Lomax ◽

Bryan Abbott ◽

Jo Adams ◽

Alice Berry ◽

...

Keyword(s):

Feasibility Study ◽

Inflammatory Arthritis ◽

Primary Outcome ◽

Time Frame ◽

Secondary Outcome ◽

Control Group ◽

Regression To The Mean ◽

Intervention Delivery ◽

Cognitive Behavioural ◽

One To One

Abstract Background/Aims Patients with inflammatory arthritis report that fatigue can be a challenging symptom to manage, with little support available. In response, we developed a brief one-to-one cognitive-behavioural manualised intervention, delivered by rheumatology health professionals (RHPs), to help patients manage their fatigue. Methods We designed a single-arm feasibility study called FREE-IA (Fatigue - Reducing its Effects through individualised support Episodes in Inflammatory Arthritis). Patients were eligible if they were ≥18 years, had a clinician confirmed diagnosis of inflammatory arthritis, scored ≥6/10 on the BRAF NRS Fatigue Impact with fatigue that they considered recurrent, frequent, and/or persistent, and were not accessing support for their fatigue. Following training, RHPs delivered 2-4 one-to-one sessions to participants. The initial two core sessions were delivered face-to-face in clinic; participants then had the option of up to two further sessions, either in clinic, by telephone or online. We proposed delivering sessions 1 and 2 within two weeks of each other, and sessions 3 and 4 in the following two weeks. Baseline data were collected before the first session (T0), and outcomes at six weeks (T1) and six months (T2). The primary outcome was fatigue impact (BRAF NRS Fatigue Effect), collected by telephone. Secondary outcomes included fatigue severity, fatigue coping, multi-dimensional impact of fatigue, disease impact and disability and measures of therapeutic mechanism (self-efficacy, and perceived confidence and autonomy to manage health). These outcomes were collected by post. This study allowed us to test the feasibility and acceptability of RHP training, study design and materials, intervention delivery and outcome collection, ahead of a possible RCT to determine intervention effectiveness. Results Eight RHPs at five hospitals delivered 113 sessions to 46 participants. Four sessions were delivered by phone and none online. Session 2 was only delivered within the two-week time frame for 37% of participants attending both core sessions. Out of a potential 138 primary and secondary outcome responses at T0, T1 and T2, there were 13 missing primary outcome responses and 27 missing secondary outcome responses. Results indicated improvements in all measures except disability at either T1 or T2, or both, with confidence intervals supporting an interpretation of improvement. Conclusion We were able to design and deliver FREE-IA training to RHPs, deliver FREE-IA sessions to patients, and collect outcomes at three time points with low levels of attrition. Outcomes in all measures except disability were in a direction to suggest improvement at T1, T2, or both. Study numbers were small, there was no control group and regression to the mean was a possibility. However, outcomes were in the direction to cautiously suggest benefit, and there is evidence of promise of the intervention. A definitive RCT is the next step to test clinical and cost effectiveness of the intervention. Disclosure S. Bridgewater: None. J. Lomax: None. B. Abbott: None. J. Adams: None. A. Berry: None. S. Creanor: None. P. Ewings: None. S. Hewlett: None. L. McCracken: None. M. Ndosi: None. J. Thorn: None. M. Urban: None. E. Dures: None.

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PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

BMJ Open ◽

10.1136/bmjopen-2021-050582 ◽

2021 ◽

Vol 11 (6) ◽

pp. e050582

Author(s):

Annette Mollerup ◽

Sofus Christian Larsen ◽

Anita Selmer Bennetzen ◽

Marius Henriksen ◽

Mette Kildevaeld Simonsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Hospital Admission ◽

Usual Care ◽

Pulmonary Disease ◽

Controlled Trial ◽

Self Care ◽

Secondary Outcome ◽

Link Type ◽

Randomised Controlled ◽

At Home

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; Pre-results.

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Reamed intramedullary nailing versus circular frame external fixation for segmental tibial fractures (STIFF-F): a mixed methods feasibility study

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00821-3 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Caroline B. Hing ◽

Elizabeth Tutton ◽

Toby O. Smith ◽

Molly Glaze ◽

Jamie R. Stokes ◽

...

Keyword(s):

Mixed Methods ◽

External Fixation ◽

Intramedullary Nailing ◽

Feasibility Study ◽

Online Survey ◽

Tibial Fracture ◽

Tibial Fractures ◽

Circular Frame ◽

Pilot Rct ◽

Randomised Controlled

Abstract Background Segmental tibial fractures are fractures in two or more areas of the tibial diaphysis resulting in a separate intercalary segment of the bone. Surgical fixation is recommended for patients with segmental tibial fractures as non-operative treatment outcomes are poor. The most common surgical interventions are intramedullary nailing (IMN) and circular frame external fixation (CFEF), but evidence about which is better is of poor quality. An adequately powered randomised controlled trial (RCT) to determine optimum treatment is required. STIFF-F aimed to assess the feasibility of a multicentre RCT comparing IMN with CFEF for segmental tibial fracture. Methods STIFF-F was a mixed-methods feasibility study comprising a pilot RCT conducted at six UK Major Trauma Centres, qualitative interviews drawing on Phenomenology and an online survey of rehabilitation. The primary outcome was recruitment rate. Patients, 16 years and over, with a segmental tibial fracture (open or closed) deemed suitable for IMN or CFEF were eligible to participate. Randomisation was stratified by site using random permuted blocks of varying sizes. Participant or assessor blinding was not possible. Interviews were undertaken with patients about their experience of injury, treatment, recovery and participation. Staff were interviewed to identify contextual factors affecting trial processes, their experience of recruitment and the treatment pathway. An online survey was developed to understand the rehabilitation context of the treatments. Results Eleven patients were screened and three recruited to the pilot RCT. Nineteen staff and four patients participated in interviews, and 11 physiotherapists responded to the survey. This study found the following: (i) segmental tibial fractures were rarer than anticipated, (ii) the complexity of the injury, study setup times and surgeon treatment preferences impeded recruitment, (iii) recovery from a segmental tibial fracture is challenging, and rehabilitation protocols are inconsistent and (iv) despite the difficulty recruiting, staff valued this research question and strived to find a way forward. Conclusion The proposed multicentre RCT comparing IMN with CFEF is not feasible. This study highlighted the difficulty of recruiting patients to an RCT of a complex rare injury over a short time period. Trial registration The study was registered with the International Standard Randomised Controlled Trials Number Registry: ISRCTN11229660

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Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-042627 ◽

2021 ◽

Vol 11 (3) ◽

pp. e042627

Author(s):

María Reina-Bueno ◽

María del Carmen Vázquez-Bautista ◽

Inmaculada C Palomo-Toucedo ◽

Gabriel Domínguez-Maldonado ◽

José Manuel Castillo-López ◽

...

Keyword(s):

Quality Of Life ◽

Randomised Controlled Trial ◽

Outcome Measures ◽

Controlled Trial ◽

Secondary Outcome ◽

Foot Orthoses ◽

Systemic Lupus ◽

Custom Made ◽

Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

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Cost-effectiveness analysis of an intimate partner violence prevention intervention targeting men, women and couples in rural Ethiopia: evidence from the Unite for a Better Life randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-042365 ◽

2021 ◽

Vol 11 (3) ◽

pp. e042365

Author(s):

Jessica Leight ◽

Negussie Deyessa ◽

Vandana Sharma

Keyword(s):

Intimate Partner Violence ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Partner Violence ◽

Controlled Trial ◽

Intimate Partner ◽

Community Level ◽

Secondary Outcome ◽

Randomised Controlled ◽

The Cost

ObjectivesExperience of intimate partner violence (IPV) is associated with adverse health and psychosocial outcomes for women. However, rigorous economic evaluations of interventions targeting IPV prevention are rare. This paper analyses the cost-effectiveness of Unite for a Better Life (UBL), a gender-transformative intervention designed to prevent IPV and HIV risk behaviours among men, women and couples.DesignWe use an economic evaluation nested within a large-scale cluster randomised controlled trial, analysing financial and economic costs tracked contemporaneously.SettingUBL was implemented in rural southern Ethiopia between 2013 and 2015.ParticipantsThe randomised controlled trial included 6770 households in 64 villages.InterventionsUBL is an intervention delivered within the context of the Ethiopian coffee ceremony, a culturally established forum for community discussion, and designed to assist participants to build skills for healthy, non-violent, equitable relationships.Primary and secondary outcome measuresThis paper reports on the unit cost and cost-effectiveness of the interventions implemented. Cost-effectiveness is measured as the cost per case of past-year physical and/or sexual IPV averted.ResultsThe estimated annualised cost of developing and implementing UBL was 2015 US$296 772, or approximately 2015 US$74 per individual directly participating in the intervention and 2015 US$5 per person annually for each community-level beneficiary (woman of reproductive age in intervention communities). The estimated cost per case of past-year physical and/or sexual IPV averted was 2015 US$2726 for the sample of direct beneficiaries, and 2015 US$194 for the sample of all community-level beneficiaries.ConclusionsUBL is an effective and cost-effective intervention for the prevention of IPV in a low and middle-income country setting. Further research should explore strategies to quantify the positive effects of the intervention across other domains.Trial registration numberNCT02311699 (ClinicalTrials.gov); AEARCTR-0000211 (AEA Registry)

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