scholarly journals Effectiveness and cost-effectiveness of Self-Help Plus (SH+) for preventing mental disorders in refugees and asylum seekers in Europe and Turkey: study protocols for two randomised controlled trials

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e030259 ◽  
Author(s):  
Marianna Purgato ◽  
Kenneth Carswell ◽  
Ceren Acarturk ◽  
Teresa Au ◽  
Sena Akbai ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Mental Disorders ◽  
Asylum Seekers ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Link Type ◽  
Self Help ◽  
Intervention Cost ◽  
Randomised Controlled ◽  
Asylum Seekers And Refugees

IntroductionThis article describes two randomised controlled trials that will evaluate the effectiveness and cost-effectiveness of Self-Help Plus (SH+), a group self-help intervention developed by the WHO to reduce distress. In these trials SH+ is being tested as a preventative intervention to lower the incidence of mental disorders in asylum seekers and refugees with psychological distress resettled in Europe and Turkey.Methods and analysisTwo prospective, multicentre, randomised, rater-blinded, parallel-group studies will follow participants over a period of 12 months. One trial will be conducted in Europe and one in Turkey. In each trial, 600 asylum seekers and refugees screening positive on the General Health Questionnaire (≥3), but without a formal diagnosis of any mental disorders according to the Mini International Neuropsychiatric Interview, will be randomly allocated to SH+or to enhanced treatment-as-usual. The primary outcome will be a lower incidence of mental disorders at 6 month follow-up. Secondary outcomes will include the evaluation of psychological symptoms, functioning, well-being, treatment acceptability and indicators of intervention cost-effectiveness.Ethics and disseminationThe two trials received ethical clearance from the local Ethics Committees of the participating sites (seven sites), as well as from the WHO Ethics Committee. All participants will provide informed consent before screening and before study inclusion (a two-step procedure). The results of the trials will be disseminated in agreement with a dissemination plan that includes publication(s) in peer-reviewed journals and presentations at relevant national and international conferences and meetings.Trials registration numbersNCT03571347,NCT03587896.

A Systematic Review of Cost-Effectiveness Analyses Alongside Randomised Controlled Trials of Acupuncture

2012 ◽  
Vol 30 (4) ◽  
pp. 273-285 ◽  
Author(s):  
Song-Yi Kim ◽  
Hyangsook Lee ◽  
Younbyoung Chae ◽  
Hi-Joon Park ◽  
Hyejung Lee
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Randomised Controlled Trials ◽  
Risk Of Bias ◽  
Economic Evaluations ◽  
Controlled Trials ◽  
German Studies ◽  
Life Years ◽  
Randomised Controlled ◽  
The Cost

Objective To summarise the evidence on the cost-effectiveness of acupuncture. Methods We identified full economic evaluations such as cost-effectiveness analysis (CEA), cost-utility analysis (CUA) and cost-benefit analysis (CBA) alongside randomised controlled trials (RCTs) that assessed the consequences and costs of acupuncture for any medical condition. Eleven electronic databases were searched up to March 2011 without language restrictions. Eligible RCTs were assessed using the Cochrane criteria for risk of bias and a modified version of the checklist for economic evaluation. The general characteristics and the results of each economic analysis such as incremental cost-effectiveness ratios (ICERs) were extracted. Results Of 17 included studies, nine were CUAs that measured quality-adjusted life years (QALYs) and eight were CEAs that assessed effectiveness of acupuncture based on improvements in clinical symptoms. All CUAs showed that acupuncture with or without usual care was cost-effective compared with waiting list control or usual care alone, with ICERs ranging from ¢3011/QALY (dysmenorrhoea) to ¢22 298/QALY (allergic rhinitis) in German studies, and from £3855/QALY (osteoarthritis) to £9951/QALY (headache) in UK studies. In the CEAs, acupuncture was beneficial at a relatively low cost in six European and Asian studies. All CUAs were well-designed with a low risk of bias, but this was not the case for CEAs. Conclusions Overall, this review demonstrates the cost-effectiveness of acupuncture. Despite such promising results, any generalisation of these results needs to be made with caution given the diversity of diseases and the different status of acupuncture in the various countries.

scholarly journals Clinical and cost-effectiveness of non-medical prescribing: a systematic review of randomised controlled trials

Physiotherapy ◽  
2019 ◽  
Vol 105 ◽  
pp. e90-e91
Author(s):  
T. Noblet ◽  
J. Marriott ◽  
E. Graham-Clarke ◽  
D. Shirley ◽  
A. Rushton
Keyword(s):  
Systematic Review ◽  
Cost Effectiveness ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Randomised Controlled

scholarly journals ‘Not clinically effective but cost-effective’ - paradoxical conclusions in randomised controlled trials with ‘doubly null’ results: a cross-sectional study

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e029596 ◽  
Author(s):  
James Raftery ◽  
HC Williams ◽  
Aileen Clarke ◽  
Jim Thornton ◽  
John Norrie ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Technology Assessment ◽  
Randomised Controlled Trials ◽  
Cost Effective ◽  
Health Technology ◽  
Controlled Trials ◽  
Cross Sectional ◽  
Null Results ◽  
Health Technology Assessment Programme ◽  
Randomised Controlled

ObjectivesRandomised controlled trials in healthcare increasingly include economic evaluations. Some show small differences which are not statistically significant. Yet these sometimes come to paradoxical conclusions such as: ‘the intervention is not clinically effective’ but ‘is probably cost-effective’. This study aims to quantify the extent of non-significant results and the types of conclusions drawn from them.DesignCross-sectional retrospective analysis of randomised trials published by the UK’s National Institute for Health Research (NIHR) Health Technology Assessment programme. We defined as ‘doubly null’ those trials that found non-statistically significant differences in both primary outcome and cost per patient. Paradoxical was defined as concluding in favour of an intervention, usually compared with placebo or usual care. No human participants were involved. Our sample was 226 randomised trial projects published by the Health Technology Assessment programme 2004 to 2017. All are available free online.ResultsThe 226 projects contained 193 trials with a full economic evaluation. Of these 76 (39%) had at least one ‘doubly null’ comparison. These 76 trials contained 94 comparisons. In these 30 (32%) drew economic conclusions in favour of an intervention. Overall report conclusions split roughly equally between those favouring the intervention (14), and those favouring either the control (7) or uncertainty (9).DiscussionTrials with ‘doubly null’ results and paradoxical conclusions are not uncommon. The differences observed in cost and quality-adjustedlife year were small and non-statistically significant. Almost all these trials were also published in leading peer-reviewed journals. Although some guidelines for reporting economic results require cost-effectiveness estimates regardless of statistical significance, the interpretability of paradoxical results has nowhere been addressed.ConclusionsReconsideration is required of the interpretation of cost-effectiveness analyses in randomised controlled trials with ‘doubly null’ results, particularly when economics favours a novel intervention.

scholarly journals Clinical and cost-effectiveness of non-medical prescribing: A systematic review of randomised controlled trials

PLoS ONE ◽  
2018 ◽  
Vol 13 (3) ◽  
pp. e0193286 ◽  
Author(s):  
Timothy Noblet ◽  
John Marriott ◽  
Emma Graham-Clarke ◽  
Debra Shirley ◽  
Alison Rushton
Keyword(s):  
Systematic Review ◽  
Cost Effectiveness ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Randomised Controlled

scholarly journals Increasing engagement in advance care planning using a behaviour change model: study protocol for the STAMP randomised controlled trials

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e025340 ◽  
Author(s):  
Terri R Fried ◽  
Colleen A Redding ◽  
Steven Martino ◽  
Andrea Paiva ◽  
Lynne Iannone ◽  
...  
Keyword(s):  
Usual Care ◽  
Behaviour Change ◽  
Advance Care Planning ◽  
Randomised Controlled Trials ◽  
Institutional Review Boards ◽  
Controlled Trials ◽  
Care Planning ◽  
Link Type ◽  
Advance Care ◽  
Randomised Controlled

IntroductionAdvance care planning (ACP) is a key component of high-quality end-of-life care but is underused. Interventions based on models of behaviour change may fill an important gap in available programmes to increase ACP engagement. Such interventions are designed for broad outreach and flexibility in delivery. The purpose of the Sharing and Talking about My Preferences study is to examine the efficacy of three behaviour change approaches to increasing ACP engagement through two related randomised controlled trials being conducted in different settings (Veterans Affairs (VA) medical centre and community).Methods and analysisEligible participants are 55 years or older. Participants in the community are being recruited in person in primary care and specialty outpatient practices and senior living sites, and participants in the VA are recruited by telephone. In the community, randomisation is at the level of the practice or site, with all persons at a given practice/site receiving either computer-tailored feedback with a behaviour stage-matched brochure (computer-tailored intervention (CTI)) or usual care. At the VA, randomisation is at the level of the participant and is stratified by the number of ACP behaviours completed at baseline. Participants are randomised to one of four groups: CTI, motivational interviewing, motivational enhancement therapy or usual care. The primary outcome is completion of four key ACP behaviours: identification of a surrogate decision maker, communication about goals, completing advance directives and ensuring documents are in the medical record. Analysis will be conducted using mixed effects models, taking into account the clustered randomisation for the community study.Ethics and randomisationThe studies have been approved by the appropriate Institutional Review Boards and are being overseen by a Safety Monitoring Committee. The results of these studies will be disseminated to academic audiences and leadership in in the community and VA sites.Trial registration numbersNCT03137459andNCT03103828.

scholarly journals Child outcomes after induction of labour or expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks of gestation: study protocol of the PPROMEXIL Follow-up trial. A long-term follow-up study of the randomised controlled trials PPROMEXIL and PPROMEXIL-2

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046046
Author(s):  
Annemijn A de Ruigh ◽  
Noor E Simons ◽  
Janneke Van ‘t Hooft ◽  
Aleid G van Wassenaer-Leemhuis ◽  
Cornelieke S H Aarnoudse-Moens ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Expectant Management ◽  
Induction Of Labour ◽  
Late Preterm ◽  
Controlled Trials ◽  
Link Type ◽  
Long Term Follow Up ◽  
Randomised Controlled

IntroductionLate preterm prelabour rupture of membranes (PROM between 34+0 and 36+6 weeks gestational age) is an important clinical dilemma. Previously, two large Dutch randomised controlled trials (RCTs) compared induction of labour (IoL) to expectant management (EM). Both trials showed that early delivery does not reduce the risk of neonatal sepsis as compared with EM, although prematurity-related risks might increase. An extensive, structured long-term follow-up of these children has never been performed.Methods and analysisThe PPROMEXIL Follow-up trial (NL6623 (NTR6953)) aims to assess long-term childhood outcomes of the PPROMEXIL (ISRCTN29313500) and PPROMEXIL-2 trial (ISRCTN05689407), two multicentre RCTs using the same protocol, conducted between 2007 and 2010 evaluating IoL versus EM in women with late preterm PROM. The PPROMEXIL Follow-up will analyse children of mothers with a singleton pregnancy (PPROMEXIL trial n=520, PPROMEXIL-2 trial n=191, total IoL n=359; total EM n=352). At 10–12 years of age all surviving children will be invited for a neurodevelopmental assessment using the Wechsler Intelligence Scale for Children-V, Color-Word Interference Test and the Movement Assessment Battery for Children-2. Parents will be asked to fill out questionnaires assessing behaviour, motor function, sensory processing, respiratory problems, general health and need for healthcare services. Teachers will fill out the Teacher Report Form and answer questions regarding school attainment. For all tests means with SDs will be compared, as well as predefined cut-off scores for abnormal outcome. Sensitivity analyses consisting of different imputation techniques will be used to deal with lost to follow-up.Ethics and disseminationThe study has been granted approval by the Medical Centre Amsterdam (MEC) of the AmsterdamUMC (MEC2016_217). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders. This protocol is published before analysis of the results.Trial registration numberNL6623 (NTR6953).

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