Tensions between the conduct of randomised controlled trials in health promotion research and the role of autonomy in human health and well being

BackgroundHomelessness is associated with poor health. A policy approach aiming to end homelessness across Europe and North America, the ‘Housing First’ (HF) model, provides rapid housing, not conditional on abstinence from substance use. We aimed to systematically review the evidence from randomised controlled trials for the effects of HF on health and well-being.MethodsWe searched seven databases for randomised controlled trials of interventions providing rapid access to non-abstinence-contingent, permanent housing. We extracted data on the following outcomes: mental health; self-reported health and quality of life; substance use; non-routine use of healthcare services; housing stability. We assessed risk of bias and calculated standardised effect sizes.ResultsWe included four studies, all with ‘high’ risk of bias. The impact of HF on most short-term health outcomes was imprecisely estimated, with varying effect directions. No clear difference in substance use was seen. Intervention groups experienced fewer emergency department visits (incidence rate ratio (IRR)=0.63; 95% CI 0.48 to 0.82), fewer hospitalisations (IRR=0.76; 95% CI 0.70 to 0.83) and less time spent hospitalised (standardised mean difference (SMD)=−0.14; 95% CI −0.41 to 0.14) than control groups. In all studies intervention participants spent more days housed (SMD=1.24; 95% CI 0.86 to 1.62) and were more likely to be housed at 18–24 months (risk ratio=2.46; 95% CI 1.58 to 3.84).ConclusionHF approaches successfully improve housing stability and may improve some aspects of health. Implementation of HF would likely reduce homelessness and non-routine health service use without an increase in problematic substance use. Impacts on long-term health outcomes require further investigation.Trial registration numberCRD42017064457

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The effects of welfare to work interventions on the health and well-being of lone parents and their children – a systematic review of randomised controlled trials

European Journal of Public Health ◽

10.1093/eurpub/cku161.010 ◽

2014 ◽

Vol 24 (suppl_2) ◽

Cited By ~ 1

Author(s):

M Gibson ◽

K Banas ◽

V Lutje ◽

MJ McKee ◽

S Martin ◽

...

Keyword(s):

Systematic Review ◽

Randomised Controlled Trials ◽

Well Being ◽

Controlled Trials ◽

Welfare To Work ◽

Lone Parents ◽

Randomised Controlled ◽

Health And Well Being

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Study design, rationale and methods of the Revitalising Informal Settlements and their Environments (RISE) study: a cluster randomised controlled trial to evaluate environmental and human health impacts of a water-sensitive intervention in informal settlements in Indonesia and Fiji

BMJ Open ◽

10.1136/bmjopen-2020-042850 ◽

2021 ◽

Vol 11 (1) ◽

pp. e042850

Author(s):

Karin Leder ◽

John J Openshaw ◽

Pascale Allotey ◽

Ansariadi Ansariadi ◽

S Fiona Barker ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Human Health ◽

Controlled Trial ◽

Informal Settlements ◽

Cluster Randomised Controlled Trial ◽

Well Being ◽

Cluster Randomised ◽

Abundance And Diversity ◽

Randomised Controlled ◽

Health And Well Being

IntroductionIncreasing urban populations have led to the growth of informal settlements, with contaminated environments linked to poor human health through a range of interlinked pathways. Here, we describe the design and methods for the Revitalising Informal Settlements and their Environments (RISE) study, a transdisciplinary randomised trial evaluating impacts of an intervention to upgrade urban informal settlements in two Asia-Pacific countries.Methods and analysisRISE is a cluster randomised controlled trial among 12 settlements in Makassar, Indonesia, and 12 in Suva, Fiji. Six settlements in each country have been randomised to receive the intervention at the outset; the remainder will serve as controls and be offered intervention delivery after trial completion. The intervention involves a water-sensitive approach, delivering site-specific, modular, decentralised infrastructure primarily aimed at improving health by decreasing exposure to environmental faecal contamination. Consenting households within each informal settlement site have been enrolled, with longitudinal assessment to involve health and well-being surveys, and human and environmental sampling. Primary outcomes will be evaluated in children under 5 years of age and include prevalence and diversity of gastrointestinal pathogens, abundance and diversity of antimicrobial resistance (AMR) genes in gastrointestinal microorganisms and markers of gastrointestinal inflammation. Diverse secondary outcomes include changes in microbial contamination; abundance and diversity of pathogens and AMR genes in environmental samples; impacts on ecological biodiversity and microclimates; mosquito vector abundance; anthropometric assessments, nutrition markers and systemic inflammation in children; caregiver-reported and self-reported health symptoms and healthcare utilisation; and measures of individual and community psychological, emotional and economic well-being. The study aims to provide proof-of-concept evidence to inform policies on upgrading of informal settlements to improve environments and human health and well-being.EthicsStudy protocols have been approved by ethics boards at Monash University, Fiji National University and Hasanuddin University.Trial registration numberACTRN12618000633280; Pre-results.

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Little evidence from randomised controlled trials regarding effects of routine health promotion interventions for pregnant women

Evidence-Based Nursing ◽

10.1136/ebn.13.1.20 ◽

2010 ◽

Vol 13 (1) ◽

pp. 20-21

Author(s):

M. M Aruda

Keyword(s):

Health Promotion ◽

Pregnant Women ◽

Randomised Controlled Trials ◽

Controlled Trials ◽

Randomised Controlled ◽

Health Promotion Interventions

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The Role of Extra Corporeal Membrane Oxygenation for Treatment of the Adult Respiratory Distress Syndrome: Review and Quantitative Analysis

Anaesthesia and Intensive Care ◽

10.1177/0310057x0803600203 ◽

2008 ◽

Vol 36 (2) ◽

pp. 152-161 ◽

Cited By ~ 29

Author(s):

R. P. Chalwin ◽

J. L. Moran ◽

P. L. Graham

Keyword(s):

Respiratory Distress Syndrome ◽

Respiratory Distress ◽

Adult Respiratory Distress Syndrome ◽

Randomised Controlled Trials ◽

Distress Syndrome ◽

Controlled Trials ◽

Extra Corporeal Membrane Oxygenation ◽

Membrane Oxygenation ◽

Randomised Controlled

The role of Extra corporeal membrane oxygenation (ECMO) has not been formally validated for patients with adult respiratory distress syndrome. In anticipation of publication of the conventional ventilation versus ECMO in severe adult respiratory failure (CESAR) trial, the role of ECMO in this setting was reviewed. An electronic search for studies reporting the use of ECMO for the treatment of adult respiratory distress syndrome revealed two randomised controlled trials and three non-controlled trials. Bayesian analysis on the two randomised controlled trials produced an odds ratio mortality of 1.28 (credible interval 0.24 to 6.55) demonstrating no significant harm or benefit. Pooling was not possible for the non-controlled studies because of differing admission status and ECMO selection criteria and an inability to control for these differences in the absence of individual patient data. A large number (n=35) of case series have been published with generally more positive results. We also present a comprehensive narrative commentary on the history, current practice and future for ECMO. ECMO, as rescue therapy for adult respiratory distress syndrome, appears to be an unvalidated rescue treatment option. Analysis and review of trial data does not support its application; however the body of reported cases suggests otherwise. Until the CESAR trial provides an authoritative answer ECMO will continue to be offered on a case by case basis.

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