Understanding and optimising patient and public involvement in trial oversight: an ethnographic study of eight clinical trials.

BACKGROUND: Trial oversight is important for trial governance and conduct. Patients and/or lay members of the public are increasingly included in trial oversight committees, influenced by international patient and public involvement (PPI) initiatives to improve the quality and relevance of research. However, there is a lack of guidance on how to undertake PPI in trial oversight and tokenistic PPI remains an issue. This paper explores how PPI functions in existing trial oversight committees and provides recommendations to optimise PPI in future trials. This was part of a larger study investigating the role and function of oversight committees in trials facing challenges. METHODS: Using an ethnographic study design, we observed oversight meetings of eight UK trials and conducted semi-structured interviews with members of their trial steering committees (TSCs) and trial management groups (TMGs) including public contributors, trial sponsors and funders. Thematic analysis of data was undertaken, with findings integrated to provide a multi-perspective account of how PPI functions in trial oversight. RESULTS: Eight TSC and six TMG meetings from eight trials were observed, and 66 semi-structured interviews conducted with 52 purposively sampled oversight group members, including three public contributors. PPI was reported as beneficial in trial oversight, with public members contributing a patient voice and fulfilling a patient advocacy role. However, public contributors were not always active at oversight meetings and were sometimes felt to have a tokenistic role, with trialists reporting a lack of understanding of how to undertake PPI in trial oversight. To optimise PPI in trial oversight, the following areas were highlighted: the importance of planning effective strategies to recruit public contributors; considering the level of oversight and stage(s) of trial to include PPI; support for public contributors by the trial team between and during oversight meetings. CONCLUSIONS: We present evidence-based recommendations to inform future PPI in trial oversight. Consideration should be given at trial design stage on how to recruit and involve public contributors within trial oversight, as well as support and mentorship for both public contributors and trialists (in how to undertake PPI effectively). Findings from this study further strengthen the evidence base on facilitating meaningful PPI within clinical trials.

Use of alternative medicines in diabetes mellitus.

AIMS: Enormous advances have been made in medical care but more people are still using herbal or alternative remedies. In chronic conditions such as diabetes patients may turn to alternative remedies that have been purported to improve glycaemic control. This study surveyed diabetic and control subjects about their use of all prescribed medication, over-the-counter supplements, and alternative medications. METHODS: Subjects were prospectively contacted in person or by telephone. Five hundred and two diabetic subjects and 201 control subjects were asked to provide details about themselves, their diabetes (for the diabetic subjects) and their use of prescribed medication, over-the-counter supplements and alternative medications. Subjects were asked to rank their assessment of the effectiveness of each medication. Costs were calculated on a per month basis from average prices obtained from five alternative health stores and five chemist shops. RESULTS: Of the diabetic subjects, 78% were taking prescribed medication for their diabetes, 44% were taking over-the-counter supplements and 31% were taking alternative medications. Of the control subjects, 63% were taking prescribed medication, 51% were taking over-the-counter supplements, and 37% were taking alternative medications. Multivitamins, vitamin E, vitamin C, calcium and aspirin were the most commonly used over the counter supplements. Garlic, echinacea, herbal mixtures, glucosamine were the most commonly used alternative medications. Chromium was used only by diabetic subjects and then only rarely. Subjects rated the effectiveness of the alternative medications significantly lower than for prescribed medications but still thought them efficacious. Alternative medications purported to have some hypoglycaemic effect were little used by diabetic subjects. Diabetic subjects spent almost as much money on over-the-counter supplements and alternative medications together as they did on their diabetic medications. CONCLUSIONS: One-third of diabetic patients are taking alternative medications that they consider efficacious but this is no more than in the control group. The money spent on alternative and non-prescription supplements nearly equals that spent on prescription medications. In view of the money spent in this area the time is past due to evaluate these remedies and to establish what merit they have.

Oat bran concentrate bread products improve long-term control of diabetes: a pilot study.

OBJECTIVE: To evaluate the long-term effects oat bran concentrate bread products in the diet of free-living subjects with non-insulin-dependent diabetes (NIDDM) via dietary, clinical, and biochemical methods. DESIGN: A 24-week crossover study consisting of two 12-week periods. SUBJECTS/SETTING: Eight men with NIDDM (mean age = 45 years) who lived in the community. Glucose and insulin profiles were conducted in a clinical investigation unit. INTERVENTION: Palatable, high-fiber, oat bran concentrate (soluble fiber [beta-glucan] content = 22.8%) bread products were developed. Four randomly chosen subjects ate oat bran concentrate breads first; the other subjects ate control white bread first. MAIN OUTCOME MEASURES: Dietary intake (four 48-hour dietary recalls per period) was assessed. Blood glucose and insulin (8-hour profiles) and lipid parameters after fasting were measured (at 0, 12, and 24 weeks). STATISTICAL ANALYSES PERFORMED: Analysis of variance and repeated-measures analysis of variance. RESULTS: Total energy and macronutrient intakes were similar in both periods. Mean total dietary fiber intake was 19 g/day in the white bread period and 34 g/day (9 g soluble fiber per day from oat bran concentrate) in the oat bran concentrate period. Body weight remained stable. Mean glycemic and insulin response areas (area under the curve) were lower (P < or = .05 and not significant, respectively) for the oat bran concentrate period than the white bread period. After breakfast, area under the curve for the oat bran concentrate period was lower for glucose (P < or = .01) and insulin (P < or = .05); insulin peak was reached earlier (P < or = .05) than in the white bread period. Dietary fiber intake was correlated negatively with insulin area under the curve (P < or = .05). Mean total plasma cholesterol and low-density lipoprotein cholesterol levels were lower (P < or = .01) in the oat bran concentrate period than in the white bread period. In the oat bran concentrate period, the mean ratio of low-density lipoprotein cholesterol to high-density lipoprotein cholesterol was reduced by 24% (P < or = .05). CONCLUSIONS: The well-accepted oat bran concentrate bread products improved glycemic, insulinemic, and lipidemic responses.