Search

BACKGROUND: Alcohol is challenging to discuss, and patients may be reluctant to disclose drinking partly because of concern about being judged. This report presents an overview of the development of a medications review intervention co-produced with the pharmacy profession and with patients, which breaks new ground by seeking to give appropriate attention to alcohol within these consultations. METHODS: This intervention was developed in a series of stages and refined through conceptual discussion, literature review, observational and interview studies, and consultations with advisory groups. In this study we reflect on this process, paying particular attention to the methods used, where lessons may inform innovations in other complex clinical consultations. RESULTS: Early work with patients and pharmacists infused the entire process with a heightened sense of the complexity of consultations in everyday practice, prompting careful deliberation on the implications for intervention development. This required the research team to be highly responsive to both co-production inputs and data gathered in formally conducted studies, and to be committed to working through the implications for intervention design. The intervention thus evolved significantly over time, with the greatest transformations resulting from patient and pharmacist co-design workshops in the second stage of the process, where pharmacists elaborated on the nature of the need for training in particular. The original research plans provided a helpful structure, and unanticipated issues for investigation emerged throughout the process. This underscored the need to engage dynamically with changing contexts and contents and to avoid rigid adherence to any early prescribed plan. CONCLUSIONS: Alcohol interventions are complex and require careful developmental research. This can be a messy enterprise, which can nonetheless shed new insights into the challenges involved in optimising interventions, and how to meet

BACKGROUND: Alcohol interventions are important to the developing public health role of community pharmacies. The Medicines and Alcohol Consultation (MAC) is a new intervention, co-produced with community pharmacists (CPs) and patients, which involves a CP practice development programme designed to integrate discussion of alcohol within existing NHS medicine review services. We conducted a pilot trial of the MAC and its delivery to investigate all study procedures to inform progression to a definitive trial. METHODS: This cluster pilot RCT was conducted in 10 community pharmacies in Yorkshire, UK, with a CP from each who regularly conducted Medicine Use Review (MUR) and New Medicine Service (NMS) consultations. Randomisation was conducted using a secure remote randomisation service. Intervention CPs (n = 5) were trained to deliver the MAC in MUR/NMS consultations. Control CPs (n = 5) provided these services as usual. Consecutive MUR/NMS patients were asked by CPs to participate, screened for eligibility (consumption of alcohol at least twice per week), and baseline data collected for those eligible. A two-month follow-up telephone interview was conducted. Blinding of CPs was not possible, but patients were blinded to the alcohol focus of the trial. Primary outcomes were total weekly UK units (8 g of ethanol per unit) of alcohol consumption in the week prior to follow-up, and confidence in medications management. Trial procedures were assessed by recruitment, attrition, and follow-up rates. RESULTS: 260 patients were approached by CPs to take part in the trial, 68% (n = 178) were assessed for eligibility and 30% (n = 54) of these patients were eligible. Almost all eligible patients (n = 51; 94%) consented to participate, of whom 92% (n = 47) were followed-up at 2 months; alcohol consumption was lower in the intervention arm and confidence in medication management reduced slightly for both groups. Exploration of recall issues at follow-up showed a high level of agreem

OBJECTIVES: To investigate how distressing participating in medical research is perceived to be, compared to everyday events. DESIGN: Anonymous questionnaire. SETTING: Scotland and New Zealand. PARTICIPANTS: One hundred members of the Scottish general public, 94 University of Auckland students, 22 New Zealand Ministry of Health ethics committee members. MAIN OUTCOME MEASURES: Distress ratings made on a 0-10 scale for everyday events and common medical research procedures. RESULTS: Both general population and student samples generally rated the distress caused by participating in various medical research procedures as low or very low. Most research procedures were rated less than the distress caused by not being able to find a car park at a supermarket. In contrast, the ethics committee members rated the distress caused by most of the medical research procedures at a significantly higher level than the ratings of the student and general population samples. Ethics committee members overestimated the distress caused by interview or questionnaire assessments (M = 203.31%, SE = 11.42, 95% CI [179.79, 226.83]) more than medical testing for research (M = 158.06%, SE = 12.33, 95% CI [132.66, 183.46], p = 0.04) and everyday events (M = 133.10%, SE = 7.80, 95% CI [117.03, 149.16], p < 0.001). CONCLUSIONS: Common medical research procedures are not rated as particularly distressing by the general public, and ethics committees may be adopting an over-protective role when evaluating research applications that involve the use of questionnaire or survey methodology.