Peter W Slane

Advising parents of asthmatic children on passive smoking: randomised controlled trial

Abstract Objective: To investigate whether parents of asthmatic children would stop smoking or alter their smoking habits to protect their children from environmental tobacco smoke. Design: Randomised controlled trial. Setting: Tayside and Fife, Scotland. Participants: 501 families with an asthmatic child aged 2-12 years living with a parent who smoked. Intervention: Parents were told about the impact of passive smoking on asthma and were advised to stop smoking or change their smoking habits to protect their childs health. Main outcome measures: Salivary cotinine concentrations in children, and changes in reported smoking habits of the parents 1 year after the intervention. Results: At the second visit, about 1 year after the baseline visit, a small decrease in salivary cotinine concentrations was found in both groups of children: the mean decrease in the intervention group (0.70 ng/ml) was slightly smaller than that of the control group (0.88 ng/ml), but the net difference of 0.19 ng/ml had a wide 95% confidence interval (−0.86 to 0.48). Overall, 98% of parents in both groups still smoked at follow up. However, there was a non-significant tendency for parents in the intervention group to report smoking more at follow up and to having a reduced desire to stop smoking. Conclusions: A brief intervention to advise parents of asthmatic children about the risks from passive smoking was ineffective in reducing their childrens exposure to environmental tobacco smoke. The intervention may have made some parents less inclined to stop smoking. If a clinician believes that a childs health is being affected by parental smoking, the parents smoking needs to be addressed as a separate issue from the childs health. Key messages Many asthmatic children are exposed to high levels of environmental tobacco smoke A brief intervention informing parents of asthmatic children on the harmful effects of passive smoking did not lead to a reduction in exposure of their children to tobacco smoke Low rates of smoking cessation were found in both the intervention group and the control group Some parents may have been less inclined to stop smoking after the intervention Brief interventions requesting smokers to stop for another persons health seem ineffective

Strategies for achieving a high response rate in a home interview survey

BackgroundResponse rates in surveys have been falling over the last 20 years, leading to the need for novel approaches to enhance recruitment. This study describes strategies used to maximise recruitment to a home interview survey of mothers with young children living in areas of high deprivation.MethodsMothers of two year old children received a letter from their GP inviting them to take part in a survey on diet. Participants were subsequently recruited by a researcher. The researcher first tried to contact potential participants by telephone, to discuss the study and make an appointment to conduct a home interview. Where telephone numbers for women could not be obtained from GP records, web searches of publicly available databases were conducted. After obtaining correct telephone numbers, up to six attempts were made to establish contact by telephone. If this was unsuccessful, a postal request for telephone contact was made. Where no telephone contact was achieved, the researcher sent up to two appointments by post to conduct a home interview.ResultsParticipating GPs invited 372 women to take part in a home based interview study. GP practices provided telephone numbers for 162 women, of which 134 were valid numbers. The researcher identified a further 187 numbers from electronic directories. Further searches of GP records by practice staff yielded another 38 telephone numbers. Thus, telephone numbers were obtained for 99% of potential participants.The recruitment rate from telephone contacts was 77%. Most of the gain was achieved within four calls. For the remaining women, contact by post and home visits resulted in 18 further interviews, corresponding to 35% of the women not recruited by telephone. The final interview rate was 82%. This was possible because personal contact was established with 95% of potential participants.ConclusionThis study achieved a high response rate in a hard to reach group. This was mainly achieved by first establishing contact by telephone. The use of multiple sources identified the telephone numbers of almost all the sample. Multiple attempts at telephone contact followed by postal approaches led to a high home interview rate.

Alcohol and disadvantaged men: A feasibility trial of an intervention delivered by mobile phone

Abstract Introduction and Aims Disadvantaged men suffer substantial harm from heavy drinking. This feasibility study developed and evaluated the methods for a trial of a brief intervention delivered by text messages to disadvantaged men. It aimed to test the methods for recruitment and retention, to monitor engagement with the intervention and assess the overall acceptability of study methods. Design and Methods Disadvantaged men aged 25–44 years who had ≥2 episodes of binge drinking (≥8 units in one session) in the preceding month were recruited. Two recruitment strategies were assessed: recruitment from general practice registers and by a community outreach strategy. Theoretically and empirically based text messages were tailored to the target group. Results The study recruited 67 disadvantaged men at high risk of alcohol‐related harm, exceeding the target of 60. Evaluation showed that 95% of text messages were delivered, and the men engaged enthusiastically with the intervention. Retention at follow up was 96%. Outcomes were successfully measured on all men followed up. This provided data for the sample size calculation for the full trial. Post‐study evaluation showed high levels of satisfaction with the study. Discussion and Conclusions This study has shown that disadvantaged men can be recruited and follow‐up data obtained in an alcohol intervention study. The study methods were acceptable to the participants. The men recruited were at high risk of alcohol‐related harms. It also clarified ways in which the recruitment strategy, the baseline questionnaire and the intervention could be improved. The full trial is currently underway. [Crombie IK, Irvine L, Falconer DW, Williams B, Ricketts IW, Jones C, Humphris G, Norrie J, Slane P, Rice P. Alcohol and disadvantaged men: A feasibility trial of an intervention delivered by mobile phone. Drug Alcohol Rev 2017;36:468‐476]

Modifying Alcohol Consumption to Reduce Obesity (MACRO): development and feasibility trial of a complex community-based intervention for men

BACKGROUND Obese men who consume alcohol are at a greatly increased risk of liver disease; those who drink > 14 units of alcohol per week have a 19-fold increased risk of dying from liver disease. OBJECTIVES To develop an intervention to reduce alcohol consumption in obese men and to assess the feasibility of a randomised controlled trial (RCT) to investigate its effectiveness. DESIGN OF THE INTERVENTION The intervention was developed using formative research, public involvement and behaviour change theory. It was organised in two phases, comprising a face-to-face session with trained laypeople (study co-ordinators) followed by a series of text messages. Participants explored how alcohol consumption contributed to weight gain, both through direct calorie consumption and through its effect on increasing food consumption, particularly of high-calorie foodstuffs. Men were encouraged to set goals to reduce their alcohol consumption and to make specific plans to do so. The comparator group received an active control in the form of a conventional alcohol brief intervention. Randomisation was carried out using the secure remote web-based system provided by the Tayside Clinical Trials Unit. Randomisation was stratified by the recruitment method and restricted using block sizes of randomly varying lengths. Members of the public were involved in the development of all study methods. SETTING Men were recruited from the community, from primary care registers and by time-space sampling (TSS). The intervention was delivered in community settings such as the participants home, community centres and libraries. PARTICIPANTS Men aged 35-64 years who had a body mass index (BMI) of > 30 kg/m2 and who drank > 21 units of alcohol per week. RESULTS The screening methods successfully identified participants meeting the entry criteria. Trial recruitment was successful, with 69 men (36 from 419 approached in primary care, and 33 from 470 approached via TSS) recruited and randomised in 3 months. Of the 69 men randomised, 35 were allocated to the intervention group and 34 to the control group. The analysis was conducted on 31 participants from the intervention group and 30 from the control group. The participants covered a wide range of ages and socioeconomic statuses. The average alcohol consumption of the men recruited was 47.2 units per week, more than twice that of the entry criterion (> 21 units per week). Most (78%) engaged in binge drinking (> 8 units in a session) at least weekly. Almost all (95%) exceeded the threshold for a 19-fold increase in the risk of dying from liver disease (BMI of > 30 kg/m2 and > 14 units of alcohol per week). Despite this, they believed that they were at low risk of harm from alcohol, possibly because they seldom suffered acute harms (e.g. hangovers) and made few visits to a general practitioner or hospital. INTERVENTION The intervention was delivered with high fidelity. A high follow-up rate was achieved (98%) and the outcomes for the full RCT were measured. A process evaluation showed that participants engaged with the main components of the intervention. The acceptability of the study methods was high. CONCLUSIONS This feasibility study developed a novel intervention and evaluated all of the stages of a RCT that would test the effectiveness of the intervention. The main stages of a trial were completed successfully: recruitment, randomisation, intervention delivery, follow-up and measurement of study outcomes. Most of the men recruited drank very heavily and were also obese. This places them at a very high risk of liver disease, making them a priority for intervention. FUTURE WORK A RCT to test the effectiveness and cost-effectiveness of the intervention. TRIAL REGISTRATION Current Controlled Trials ISRCTN55309164. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 19. See the NIHR Journals Library website for further project information.

Risky single-occasion drinking and disadvantaged men: will recruitment through primary care miss hazardous drinkers?

BACKGROUND Men who are socially disadvantaged are at a substantially higher risk of developing alcohol-related diseases. People from deprived areas are known to be more difficult to recruit to research studies. As part of a feasibility assessment for an intervention study, 2 recruitment strategies were investigated. This article compares the drinking patterns of the disadvantaged men identified by the 2 strategies. METHODS A cross-sectional survey compared 2 strategies for recruiting disadvantaged men to a study on alcohol consumption: recruitment through general practice (GP) registers and through a community outreach strategy, respondent-driven sampling (RDS). Men aged 25 to 44 years were recruited from deprived areas in the community. The entry criterion was binge drinking (≥8 units in a single session) at least twice in the previous 4 weeks. Demographic characteristics, total consumption of alcohol, frequency of binge drinking (≥8 units in a session), and heavy binge drinking (≥16 units in a session) were measured. RESULTS Men recruited by RDS drank more than twice as much as the men recruited through GP (137 units in the previous 30 days compared with 62 units; p = 0.003). They also had many more binge drinking days: more than half (57%) of men from RDS had 6 or more binge drinking days in the previous 30 days, whereas only 16% of the GP sample had 6 or more binge drinking days (p = 0.001). Many more men recruited by RDS (37% vs. 5%; p = 0.002) had more than 5 very heavy drinking sessions in the previous month (≥16 units in a session). The RDS group also had fewer alcohol-free days. CONCLUSIONS The 2 sampling strategies recruited different types of drinkers. The men recruited through RDS were much more likely to engage in frequent harmful drinking. The results indicate that the 2 methods recruit different samples of disadvantaged men. Intervention studies that are only conducted through primary care may miss many harmful drinkers.

Modifying Alcohol Consumption to Reduce Obesity: A Randomized Controlled Feasibility Study of a Complex Community-based Intervention for Men

Abstract Objectives Being obese and drinking more than 14 units of alcohol per week places men at very high risk of developing liver disease. This study assessed the feasibility of a trial to reduce alcohol consumption. It tested the recruitment strategy, engagement with the intervention, retention and study acceptability. Methods Men aged 35–64 years who drank >21 units of alcohol per week and had a BMI > 30 were recruited by two methods: from GP patient registers and by community outreach. The intervention was delivered by a face to face session followed by a series of text messages. Trained lay people (Study Coordinators) delivered the face to face session. Participants were followed up for 5 months from baseline to measure weekly alcohol consumption and BMI. Results The recruitment target of 60 was exceeded, with 69 men recruited and randomized. At baseline, almost all the participants (95%) exceeded the threshold for a 19-fold increase in the risk of dying from liver disease. The intervention was delivered with high fidelity. A very high follow-up rate was achieved (98%) and the outcomes for the full trial were measured. Process evaluation showed that participants responded as intended to key steps in the behaviour change strategy. The acceptability of the study methods was high: e.g. 80% of men would recommend the study to others. Conclusions This feasibility study identified a group at high risk of liver disease. It showed that a full trial could be conducted to test the effectiveness and cost-effectiveness of the intervention. Trial registration Current controlled trials: ISRCTN55309164. Trial funding National Institute for Health Research Health Technology Assessment (NIHR HTA). Short summary This feasibility study recruited 69 men at high risk of developing liver disease. The novel intervention, to reduce alcohol consumption through the motivation of weight loss, was well received. A very high follow-up rate was achieved. Process evaluation showed that participants engaged with key components of the behaviour change strategy.