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The purpose of this paper is to report the process evaluation of a pilot randomised control trial of an anti-smoking intervention for Malaysian 13-14-year olds, conducted in 2011/2012. It was hypothesised that trained peer supporters would promote non-smoking among classmates through informal conversations.

Smoking-related baseline and follow-up questionnaires were administered, seven months apart, to Form 1 students (n=2,118) attending eight schools across two districts in Sabah (Kota Kinabalu; Keningau). Concealed stratified randomisation assigned two schools per district to the control and intervention arms. Control schools received usual care. Intervention schools received usual care and the peer supporter intervention. Peer supporters completed smoking-related knowledge and attitudes questionnaires before and after peer supporter training and peer supporter training evaluation questionnaires. They also discussed the peer supporter training and role in focus groups immediately following training (n=4) and three months later (n=3), and additionally, recorded post-training anti-smoking activity in diaries.

The pilot trial found that student recruitment was high (baseline students matched at follow-up n=1,681 (79 per cent of class-registered students). More boys (n=38) than girls (n=35) attended peer supporter training. Post-training, most peer supporters had improved smoking-related knowledge (n=55; 75 per cent) and attitudes (n=57; 78 per cent) and returned diaries (n=49; 67 per cent). Some focus group boys reported they were reluctant peer supporters and/or found resisting smoking difficult.

Future trials would benefit from outlined modifications to peer supporter selection, recruitment and training and additionally, assessments of context and intervention acceptability and reach.

Trials of complex public health interventions are scarce in economically developing countries.

The purpose of this study was to assess whether a multifaceted intervention could improve mental health literacy, facilitate help seeking and reduce psychological distress and alcohol misuse in staff of a multi-campus university in Australia.

In this cluster randomised trial (ACTRN12610001027000), nine campuses were paired, with one of each pair randomly assigned to either intervention or control. Interventions (which were whole-of-campus) included e-mails, posters, campus events, factsheets/booklets and mental health first aid training courses. A monitoring sample of staff were recruited from each campus. Participants had a 20-minute computer-assisted telephone interview at baseline, and at the end of academic years 1 and 2. The interview assessed mental health literacy, help seeking for mental health problems, psychological distress and alcohol use. The primary outcomes were depression and anxiety levels and alcohol use and pertained to the individual level. Six campuses were randomised to intervention and three to control and all campuses were included in the analysis.

There were no effects on depression and anxiety levels and alcohol use. Recall of intervention elements was greater in the intervention group at the end of the two-year assessment period. Staff in the intervention group showed better recognition of depression, greater knowledge of the National Health and Medical Research Council guidelines for safe levels of drinking and a greater intention to seek help for alcohol misuse from a general practitioner.

Future interventions should involve more focused interventions that include consideration of working conditions and their influence on mental health, as well as addressing mental illness among employees, regardless of cause.

The aim of this randomised intervention study was to test the use of two counselling styles in reducing alcohol consumption in offenders who were hazardous drinkers and who had been charged with alcohol‐related offences. An additional aim was to evaluate the research process itself before embarking on a larger trial. Participants were recruited from a police custody suite in the south east of England and randomised to receive either a motivational interviewing brief intervention (MIBI) or a standard brief intervention (BI). The Alcohol Use Disorder Identification Test (AUDIT) was used to screen offenders for hazardous drinking. Participants were asked to complete a second AUDIT 12 weeks later. Two hundred offenders with alcohol‐related offences were screened over a 10‐month period. Of these, 182 were alcohol dependent and were therefore excluded from the study. Of the 18 who were eligible to enter the study, six refused to participate. Five were randomised to the MIBI group and seven into the BI group (BI). The mean age of the MIBI group was 25 (SD±3.86) years and the mean age of the BI group was 32.4 (SD±7.9). Audit scores were significantly lower at time 2 compared to time 1 for both intervention groups (t(11) = 17.60; p < 0.05). There was no significant difference between the different intervention groups.

The purpose of this paper is to evaluate the effectiveness of a free book gifting programme, called “Bookstart+”, in improving family reading outcomes.

Bookstart+ consists of a pack of books and reading materials provided to families at their two-year-old child's statutory health visit. The pack is accompanied by a short priming demonstration, delivered by the health visitor, on shared reading. The evaluation took the form of a randomised controlled trial (RCT) with 460 families from the client lists of 115 health visitors.

The study found evidence of: a positive significant effect on parents’ attitudes to reading and books (Cohen's d=+0.192, p=0.034); no significant effect on parental attitudes to their child reading (d=+0.085, p=0.279); and a negative effect, approaching significance, on public library usage (d=−0.160, p=0.055).

The attrition rate was high, with only 43.9 per cent of the target families completing all of the research. However, this level of attrition did not lead to any significant differences between the control and intervention groups on their pre-test measures.

The study provides recommendations for free book gifting service provision in relation to pack contents and delivery.

This paper contributes to the limited international RCT evidence on free book gifting programmes.

Community-based HIV testing and counselling (HTC) has been recommended for improving access to prevention, care, and treatment services in at-risk populations. Earlier systematic reviews and meta-analyses have been undertaken, but due to some methodological limitations, their findings do not yet provide a practical significance. The purpose of this paper is to re-examine the recent evidence of the efficacy of community-based HTC approaches on the uptake of HTC in at-risk populations.

The database of PubMed online, Science Direct, the Lancet Global Health, the Cochrane Central Register of Controlled Trials, and Google Scholar were systematically searched using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to obtain empirical papers published between March 2013 and December 2015.

Of 600 collected papers, there were 6 cluster randomized trials papers which met the inclusion criteria. Compared to the health facilities-based HTC, community-based HTC approaches have been shown to improve the uptake of HIV testing from 5.8 to 37 per cent, and improve HIV testing in men and their partners together from 6.8 to 34 per cent. The community approaches also detected lower HIV-positive cases (0.29 per cent as compared to 4 per cent), improved access to treatment services from 0.3 to 25 per cent, demonstrated higher cluster differentiation 4 count in newly diagnosed patients (median of 400-438 cells/µl), and increased the rate of first-time HIV testing from 9 to 11.8 per cent. With respect to social and behavioural outcomes, community-based HTC increased social norms for HIV testing by 6 per cent (95 per cent CI 3-9), decreased multiple sex partners by 55 per cent (95 per cent CI 42-73), lowered casual sex by 45 per cent (95 per cent CI 33-62), increased knowledge about HIV (83.2 vs 28.9 per cent), improved positive attitudes towards HIV patients (73.0 vs 34.3 per cent), and increased the use of condoms (28.0 vs 12.3 per cent).

Community-based HTC combined with behavioural interventions have been found to be more effective in increasing the uptake of HIV testing as well as other outcomes as compared to the conventional health facilities-based testing and counselling approaches.

Involvement of parents/carers may increase effectiveness of primary school-based alcohol-misuse prevention projects through strengthening family-based protective factors, but rates of parental engagement are typically low. This paper reports findings from an exploratory trial of a school-based prevention intervention – Kids, Adults Together (KAT), based on the Social Development Model, which aimed to promote pro-social family communication in order to prevent alcohol misuse, and incorporated strategies to engage parents/carers. The purpose of this paper is to assess the feasibility and value of conducting an effectiveness trial of KAT.

The study was a parallel-group cluster randomised exploratory trial with an embedded process evaluation. The study took place in south Wales, UK, and involved nine primary schools, 367 pupils in Years 5/6 (aged 9-11 years) and their parents/carers and teachers. Questionnaires were completed by pupils at baseline and four month follow-up, and by parents at six month follow-up.

Overall KAT was delivered with good fidelity, but two of five intervention schools withdrew from the study without completing implementation. In total, 50 per cent of eligible parents participated in the intervention, and KAT had good acceptability among pupils, parents and teachers. However, a number of “progression to effectiveness trial” criteria were not met. Intermediate outcomes on family communication (hypothesised to prevent alcohol misuse) showed insufficient evidence of an intervention effect. Difficulties were encountered in identifying age appropriate outcome measures for primary school-age children, particularly in relation to family communication processes. The study was unable to find comprehensive methodological guidance on exploratory trials.

It would not be appropriate to conduct an effectiveness trial as key progression criteria relating to intervention and trial feasibility were not met. There is a need for new measures of family communication which are suitable for primary school-age children, and more guidance on the design and conduct of exploratory/feasibility trials.

KAT achieved high rates of parental involvement, and its theoretical framework and processes could be adapted by other interventions which experience difficulties with recruitment of parents/carers.

Interest has grown in integrated care models as means of responding better to the needs of frail older adults. In order to provide appropriate input for health policy reforms, the effects of integrated care must be assessed with sound methodologies. Based on three experiments conducted in the province of Quebec, Canada, this article provides practical advice on key issues involved in evaluating integrated care models.

Examines a particular system for reporting clinical trials: the revised CONSORT system. Identifies its evolution and key components, indicating who may go on to use it, posting its key strengths, and concludes by identifying its outstanding limitations.

The widespread deployment of telehealth (TH) has been conducted in the absence of any clear understanding of how acceptable these devices are to patients. One potential limitation of the widespread deployment of TH is that patients may refuse. Moreover an understanding of the reasons for refusing to use TH devices will provide an understanding of the barriers.

This investigation from the Whole Systems Demonstrator (WSD) programme, a pragmatic cluster randomised controlled trial into the effectiveness of TH, examined reasons for patients in the intervention cohort of the trial refusing TH, and the potential barriers to its deployment.

Active rejection of the TH intervention was the most frequent reason for withdrawal. After examination of trial-related, health, socio-demographic, cognitive, emotional and behavioural factors, patients diagnosed with diabetes, as opposed to heart failure or chronic obstructive pulmonary disease, and patients’ beliefs about the acceptability of the intervention predicted whether or not they withdrew from the trial because of the intervention.

Beliefs that the TH intervention resulted in increased accessibility to care, satisfaction with equipment and fewer concerns about the privacy, safety and discomfort associated with using TH equipment predicted continued participation in the WSD trial. Findings suggest that potentially modifiable beliefs about TH predict those more likely to reject the intervention. These findings have important implications for understanding individual differences in the acceptance of TH and subsequent success in mainstreaming TH in healthcare services.