Texting to Reduce Alcohol Misuse (TRAM): main findings from a randomized controlled trial of a text message intervention to reduce binge drinking among disadvantaged men.

AIMS: To test the effectiveness of a theoretically based text-message intervention to reduce binge drinking among socially disadvantaged men. DESIGN: A multi-centre parallel group, pragmatic, individually randomized controlled trial. SETTING: Community-based study conducted in four regions of Scotland. PARTICIPANTS: A total of 825 men aged 25-44 years recruited from socially disadvantaged areas who had two or more episodes of binge drinking (> 8 UK units on a single occasion) in the preceding 28 days: 411 men were randomized to the intervention and 414 to the control. INTERVENTION AND COMPARATOR: A series of 112 interactive text messages was delivered by mobile phone during a 12-week period. The intervention was structured around the Health Action Process Approach, a comprehensive model which allows integration of a range of evidence-based behaviour change techniques. The control group received 89 texts on general health, with no mention of alcohol or use of behaviour change techniques. MEASUREMENTS: The primary outcome measure was the proportion of men consuming > 8 units on three or more occasions (in the previous 28 days) at 12 months post-intervention. FINDINGS: The proportion of men consuming > 8 units on three or more occasions (in the previous 28 days) was 41.5% in the intervention group and 47.8% in the control group. Formal analysis showed that there was no evidence that the intervention was effective [odds ratio (OR) = 0.79, 95% confidence interval (CI) = 0.57-1.08; absolute reduction 5.7%, 95% CI = -13.3 to 1.9]. The Bayes factor for this outcome was 1.3, confirming that the results were inconclusive. The retention was high and similar in intervention (84.9%) and control (86.5%) groups. Most men in the intervention group engaged with the text messages: almost all (92%) replied to text messages and 67% replied more than 10 times. CONCLUSIONS: A theoretically based text-messaging intervention aimed at reducing binge drinking in disadvantaged men was not found to reduce prevalence of binge drinking at 12-month follow-up.

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

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].

A primary care Web-based Intervention Modeling Experiment replicated behavior changes seen in earlier paper-based experiment.

OBJECTIVES: Intervention Modeling Experiments (IMEs) are a way of developing and testing behavior change interventions before a trial. We aimed to test this methodology in a Web-based IME that replicated the trial component of an earlier, paper-based IME. STUDY DESIGN AND SETTING: Three-arm, Web-based randomized evaluation of two interventions (persuasive communication and action plan) and a "no intervention" comparator. The interventions were designed to reduce the number of antibiotic prescriptions in the management of uncomplicated upper respiratory tract infection. General practitioners (GPs) were invited to complete an online questionnaire and eight clinical scenarios where an antibiotic might be considered. RESULTS: One hundred twenty-nine GPs completed the questionnaire. GPs receiving the persuasive communication did not prescribe an antibiotic in 0.70 more scenarios (95% confidence interval [CI] = 0.17-1.24) than those in the control arm. For the action plan, GPs did not prescribe an antibiotic in 0.63 (95% CI = 0.11-1.15) more scenarios than those in the control arm. Unlike the earlier IME, behavioral intention was unaffected by the interventions; this may be due to a smaller sample size than intended. CONCLUSIONS: A Web-based IME largely replicated the findings of an earlier paper-based study, providing some grounds for confidence in the IME methodology.

A mobile phone intervention to reduce binge drinking among disadvantaged men: study protocol for a randomised controlled cost-effectiveness trial.

BACKGROUND: Socially disadvantaged men are at a substantially higher risk of developing alcohol-related problems. The frequency of heavy drinking in a single session is high among disadvantaged men. Brief alcohol interventions were developed for, and are usually delivered in, healthcare settings. The group who binge drink most frequently, young to middle-aged disadvantaged men, have less contact with health services and there is a need for an alternative method of intervention delivery. Text messaging has been used successfully to modify other adverse health behaviours. This study will test whether text messages can reduce the frequency of binge drinking by disadvantaged men. METHODS/DESIGN: Disadvantaged men aged 25 to 44 years who drank >8 units of alcohol at least twice in the preceding month will be recruited from the community. Two recruitment strategies will be used: contacting men listed in primary care registers, and a community outreach method (time-space sampling). The intended sample of 798 men will be randomised to intervention or control, stratifying by recruitment method. The intervention group will receive a series of text messages designed to reduce the frequency of binge drinking through the formation of specific action plans. The control group will receive behaviourally neutral text messages intended to promote retention in the study. The primary outcome measure is the proportion of men consuming >8 units on at least three occasions in the previous 30 days. Secondary outcomes include total alcohol consumption and the frequency of consuming more than 16 units of alcohol in one session in the previous month. Process measures, developed during a previous feasibility study, will monitor engagement with the key behaviour change components of the intervention. The study will incorporate an economic evaluation comparing the costs of recruitment and intervention delivery with the benefits of reduced alcohol-related harm. DISCUSSION: This study will assess the effectiveness of a brief intervention, delivered by text messages, aimed at reducing the frequency of binge drinking in disadvantaged men. The process measures will identify components of the intervention which contribute to effectiveness. The study will also determine whether any benefit of the intervention is justified by the costs of intervening. TRIAL REGISTRATION: ISRCTN07695192. Date assigned: 14 August 2013.

Paper-based and web-based intervention modeling experiments identified the same predictors of general practitioners' antibiotic-prescribing behavior.

OBJECTIVES: To evaluate the robustness of the intervention modeling experiment (IME) methodology as a way of developing and testing behavioral change interventions before a full-scale trial by replicating an earlier paper-based IME. STUDY DESIGN AND SETTING: Web-based questionnaire and clinical scenario study. General practitioners across Scotland were invited to complete the questionnaire and scenarios, which were then used to identify predictors of antibiotic-prescribing behavior. These predictors were compared with the predictors identified in an earlier paper-based IME and used to develop a new intervention. RESULTS: Two hundred seventy general practitioners completed the questionnaires and scenarios. The constructs that predicted simulated behavior and intention were attitude, perceived behavioral control, risk perception/anticipated consequences, and self-efficacy, which match the targets identified in the earlier paper-based IME. The choice of persuasive communication as an intervention in the earlier IME was also confirmed. Additionally, a new intervention, an action plan, was developed. CONCLUSION: A web-based IME replicated the findings of an earlier paper-based IME, which provides confidence in the IME methodology. The interventions will now be evaluated in the next stage of the IME, a web-based randomized controlled trial.

E-mail invitations to general practitioners were as effective as postal invitations and were more efficient.

OBJECTIVE: To evaluate which of two invitation methods, e-mail or post, was most effective at recruiting general practitioners (GPs) to an online trial. STUDY DESIGN AND SETTING: Randomized controlled trial. Participants were GPs in Scotland, United Kingdom. RESULTS: Two hundred and seventy GPs were recruited. Using e-mail did not improve recruitment (risk difference=0.7% [95% confidence interval -2.7% to 4.1%]). E-mail was, however, simpler to use and cheaper, costing £3.20 per recruit compared with £15.69 for postal invitations. Reminders increased recruitment by around 4% for each reminder sent for both invitation methods. CONCLUSIONS: In the Scottish context, inviting GPs to take part in an online trial by e-mail does not adversely affect recruitment and is logistically easier and cheaper than using postal invitations.

Can text messages reach the parts other process measures cannot reach: an evaluation of a behavior change intervention delivered by mobile phone?

BACKGROUND: Process evaluation is essential in developing, piloting and evaluating complex interventions. This often involves observation of intervention delivery and interviews with study participants. Mobile telephone interventions involve no face to face contact, making conventional process evaluation difficult. This study assesses the utility of novel techniques for process evaluation involving no face to face contact. METHODS: Text messages were delivered to 34 disadvantaged men as part of a feasibility study of a brief alcohol intervention. Process evaluation focused on delivery of the text messages and responses received from study participants. The computerized delivery system captured data on receipt of the messages. The text messages, delivered over 28 days, included nine which asked questions. Responses to these questions served as one technique for process evaluation by ascertaining the nature of engagement with the study and with steps on the causal chain to behavior change. RESULTS: A total of 646 SMS text messages were sent to participants. Of these, 613 messages (95%) were recorded as delivered to participants' telephones. 88% of participants responded to messages that asked questions. There was little attenuation in responses to the questions across the intervention period. Content analysis of the responses revealed that participants engaged with text messages, thought deeply about their content and provided carefully considered personal responses to the questions. CONCLUSIONS: Socially disadvantaged men, a hard to reach population, engaged in a meaningful way over a sustained period with an interactive intervention delivered by text message. The novel process measures used in the study are unobtrusive, low cost and collect real-time data on all participants. They assessed the fidelity of delivery of the intervention and monitored retention in the study. They measured levels of engagement and identified participants' reactions to components of the intervention. These methods provide a valuable addition to conventional process evaluation techniques.

Developing and evaluating interventions to reduce inappropriate prescribing by general practitioners of antibiotics for upper respiratory tract infections: a randomised controlled trial to compare paper-based and web-based modelling experiments.

BACKGROUND: Much implementation research is focused on full-scale trials with little evidence of preceding modelling work. The Medical Research Council Framework for developing and evaluating complex interventions has argued for more and better theoretical and exploratory work prior to a trial as a means of improving intervention development. Intervention modelling experiments (IMEs) are a way of exploring and refining an intervention before moving to a full-scale trial. They do this by delivering key elements of the intervention in a simulation that approximates clinical practice by, for example, presenting general practitioners (GPs) with a clinical scenario about making a treatment decision. METHODS: The current proposal will run a full, web-based IME involving 250 GPs that will advance the methodology of IMEs by directly comparing results with an earlier paper-based IME. Moreover, the web-based IME will evaluate an intervention that can be put into a full-scale trial that aims to reduce antibiotic prescribing for upper respiratory tract infections in primary care. The study will also include a trial of email versus postal invitations to participate. DISCUSSION: More effective behaviour change interventions are needed and this study will develop one such intervention and a system to model and test future interventions. This system will be applicable to any situation in the National Health Service where behaviour needs to be modified, including interventions aimed directly at the public. TRIAL REGISTRATION: ClinicalTrials (NCT): NCT01206738.

Reducing prescribing errors: can a well-designed electronic system help?

RATIONALE, AIMS AND OBJECTIVES: In this study, the aim was to investigate if an electronic prescribing system designed specifically to reduce errors would lead to fewer errors in prescribing medicines in a secondary care setting. METHOD: The electronic system was compared with paper prescription charts on 16 intensive care patients to assess any change in the number of prescribing errors. RESULTS: The overall level of compliance with nationally accepted standards was significantly higher with the electronic system (91.67%) compared with the paper system (46.73%). Electronically generated prescriptions were found to contain significantly fewer deviations (28 in 329 prescriptions, 8.5%) than the written prescriptions (208 in 408 prescriptions, 51%). CONCLUSION: Taking an interdisciplinary approach to work on the creation of a system designed to minimize the risk of error has resulted in a favoured system that significantly reduces the number of errors made.

Automated assessment of polyethylene wear in cemented acetabular components using anteroposterior radiographs of total hip replacements.

Polyethylene wear in the acetabular components of hip prostheses is implicated in loosening and failure. Radiographic measurement of wear is used to identify patients at risk and to assess prosthesis designs. This paper focuses on analysis of prostheses with cemented acetabular cups from anteroposterior (AP) radiographs. The articular surface of the femoral head and the acetabular rim marker are modelled as spherical and circular respectively, resulting in elliptical image projections. Methods for automatically localising these structures in radiographs are presented using robust ellipse fitting and various error functions. Special attention is paid to the acetabular marker since this often projects as a highly eccentric ellipse. Robust fitting enables successful localisation in the presence of clutter without the need for user interaction. Finally, the use of these ellipses as reference structures for wear estimation is investigated and the effect of eccentricity errors is highlighted.

Learning active shape models for bifurcating contours.

Statistical shape models are often learned from examples based on landmark correspondences between annotated examples. A method is proposed for learning such models from contours with inconsistent bifurcations and loops. Automatic segmentation of tibial and femoral contours in knee X-ray images is investigated as a step towards reliable, quantitative radiographic analysis of osteoarthritis for diagnosis and assessment of progression. Results are presented using various features, the Mahalanobis distance, distance weighted K-nearest neighbours, and two relevance vector machine-based methods as quality of fit measure.

Decision-making about mode of delivery after previous caesarean section: development and piloting of two computer-based decision aids.

OBJECTIVE: To develop and pilot two computer-based decision aids to assist women with decision-making about mode of delivery after a previous caesarean section (CS), which could then be evaluated in a randomized-controlled trial. BACKGROUND: Women with a previous CS are faced with a decision between repeat elective CS and vaginal birth after caesarean. Research has shown that women may benefit from access to comprehensive information about the risks and benefits of the delivery options. DESIGN: A qualitative pilot study of two novel decision aids, an information program and a decision analysis program, which were developed by a multidisciplinary research team. PARTICIPANTS AND SETTING: 15 women who had recently given birth and had previously had a CS and 11 pregnant women with a previous CS, recruited from two UK hospitals. Women were interviewed and observed using the decision aids. RESULTS: Participants found both decision aids useful and informative. Most liked the computer-based format. Participants found the utility assessment of the decision analysis program acceptable although some had difficulty completing the tasks required. Following the pilot study improvements were made to expand the program content, the decision analysis program was accompanied by a training session and a website version of the information program was developed to allow repeat access. CONCLUSIONS: This pilot study was an essential step in the design of the decision aids and in establishing their acceptability and feasibility. In general, participating women viewed the decision aids as a welcome addition to routine antenatal care. A randomized trial has been conducted to establish the effectiveness and cost-effectiveness of the decision aids.