Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial.

BACKGROUND: Complex interventions in obese pregnant women should be theoretically based, feasible and shown to demonstrate anticipated behavioural change prior to inception of large randomised controlled trials (RCTs). The aim was to determine if a) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours, and b) to refine the intervention protocol through process evaluation of intervention fidelity. METHODS: We undertook a pilot RCT of a complex intervention in obese pregnant women, comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake, and increase physical activity. Subjects included 183 obese pregnant women (mean BMI 36.3 kg/m2). RESULTS: Compared to women in the control arm, women in the intervention arm had a significant reduction in dietary glycaemic load (33 points, 95% CI -47 to -20), (p < 0.001) and saturated fat intake (-1.6% energy, 95% CI -2.8 to -0. 3) at 28 weeks' gestation. Objectively measured physical activity did not change. Physical discomfort and sustained barriers to physical activity were common at 28 weeks' gestation. Process evaluation identified barriers to recruitment, group attendance and compliance, leading to modification of intervention delivery. CONCLUSIONS: This pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity, and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a complex intervention in obese pregnant women before undertaking a large RCT. TRIAL REGISTRATION NUMBER: ISRCTN89971375.

Management of common gastrointestinal disorders: quality criteria based on patients' views and practice guidelines.

BACKGROUND: Although gastrointestinal disorders are common in general practice, clinical guidelines are not always implemented, and few patient-generated quality criteria are available to guide management. AIM: To develop quality criteria for the management of four common gastrointestinal disorders: coeliac disease, gastro-oesophageal reflux disease (GORD), inflammatory bowel disease, and irritable bowel syndrome. DESIGN OF STUDY: Qualitative study including thematic analysis of transcripts from patient focus groups and content analysis of published clinical practice guidelines. Emergent themes were synthesised by a consensus panel, into quality criteria for each condition. SETTING: Community-based practice in England, UK. METHODS: Fourteen focus groups were conducted (four for coeliac disease, irritable bowel syndrome, and inflammatory bowel disease, and two for GORD) involving a total of 93 patients (64 females, 29 males; mean age 55.4 years). Quality criteria were based on patients' views and expectations, synthesised with an analysis of clinical practice guidelines. RESULTS: A chronic disease management model was developed for each condition. Key themes included improving the timeliness and accuracy of diagnosis, appropriate use of investigations, better provision of information for patients, including access to patient organisations, better communication with, and access to, secondary care providers, and structured follow-up and regular review, particularly for coeliac disease and inflammatory bowel disease. CONCLUSION: This study provides a model for the development of quality markers for chronic disease management in gastroenterology, which is likely to be applicable to other chronic conditions.

What difference does training make? A randomized trial with waiting-list control of general practitioners seeking advanced training in drug misuse.

AIM: To measure changes in knowledge, attitudes and clinical practice of general practitioners (GPs) enrolled to receive training in the management of drug misusers. DESIGN: Two-group randomized trial with training (T) and waiting-list (WL) control comparison conditions. SETTING AND PARTICIPANTS: A total of 112 GPs working in primary care practices in England. INTERVENTIONS: A 6-month, part-time, mixed-methods training course provided by the Royal College of General Practitioners. GPs randomized to the WL control received no special training or guidance during the study period. OUTCOME MEASURES AND ANALYSIS: Knowledge, therapeutic attitudes (commitment, role security, situational constraints and prescribing confidence) and clinical practice behaviour change (numbers of drug misusers seen, treated). Intention-to-treat/train (ITT) analysis, supplemented by treatment/training received (TR) analysis. FINDINGS: Training applicants had positive attitudes towards and were already involved in the care of drug misusers. Improvements in attitudes and behaviour were greatest among the T group, although only 'role security' and 'situational constraint' reached statistical significance (ITT). A subgroup in the WL group circumvented their allocation and received training, prompting supplementary analysis by TR. Overall, GPs who received training showed markedly greater improvements in knowledge, attitudinal and prescribing confidence measures and remained more actively involved in treating drug misusers than GPs who remained in the WL control group (TR analysis). CONCLUSIONS: GPs seeking special training for the care of drug misusers are both positively disposed to this patient population and clinically active. Benefits unambiguously attributable to the course were modest. While a TR effect was observed, strict adherence to ITT analysis failed to identify significant benefits observed with the training provided. Randomisation and waiting-list controls design are insufficient as a research method for training evaluation studies if ITT analysis is used exclusively.