Toby Prevost

Fidelity of delivery of a physical activity intervention: predictors and consequences.

Assessing fidelity of behavioural interventions is important, but demanding and rarely done. This study assessed adherence to behaviour change techniques used in an intervention to increase physical activity among sedentary adults ( ProActive ; N = 365). Transcripts of 108 sessions with a sub-sample of 27 participants were assessed. An independent assessor coded adherence of four ‘facilitators’ who delivered the intervention to 208 protocol-specified facilitator behaviours (e.g. ‘elicit perceived advantages of becoming more active’) in four key sessions. Four raters classified the 208 behaviours under 14 techniques (e.g., goal setting, use of rewards) to enable calculation of adherence to techniques. Observed adherence to techniques across participants was modest (median 44%, IQR 35–62%), and lower than that reported by facilitators. Adherence differed between facilitators (range: 26–63%) and decreased across the four sessions (mean drop 9% per session, 95% confidence interval 7–11%). In this small sample facilitator adherence was unrelated to (change in) participants’ physical activity or its cognitive predictors: Attitudes, subjective norm, perceived behavioural control and intention. Future research should investigate causal pathways between fidelity indicators and outcomes in larger samples and develop and test less intensive measures of fidelity.

Investigating theoretical explanations for behaviour change: The case study of ProActive

Developing more effective behavioural interventions requires an understanding of the mechanisms of behaviour change, and methods to rigorously test their theoretical basis. The delivery and theoretical basis of an intervention protocol were assessed in ProActive, a UK trial of an intervention to increase the physical activity of those at risk of Type 2 diabetes (N = 365). In 108 intervention sessions, behaviours of facilitators were mapped to four theories that informed intervention development and behaviours of participants were mapped to 17 theoretical components of these four theories. The theory base of the intervention specified by the protocol was different than that delivered by facilitators, and that received by participants. Of the intervention techniques delivered, 25% were associated with theory of planned behaviour (TPB), 42% with self-regulation theory (SRT), 24% with operant learning theory (OLT) and 9% with relapse prevention theory (RPT). The theoretical classification of participant talk showed a different pattern, with twice the proportion associated with OLT (48%), 21% associated with TPB, 31% with SRT and no talk associated with RPT. This study demonstrates one approach to assessing the extent to which the theories used to guide intervention development account for any changes observed.

A randomized controlled trial of day hospital and day centre therapy

Objective: To compare the outcome of day hospital to day centre rehabilitation. Design: Single blind randomized controlled trial with home assessments at baseline (twice), six weeks and three months. Setting: Mainly rural health district. Day hospital and social services day centres in market towns. Subjects: One hundred and five physically disabled older patients living at home referred for day hospital rehabilitation or maintenance before discharge from hospital (66) or referred as outpatients (39). Interventions: Day hospital treatment or day centre rehabilitation by a physiotherapist and two health support workers. Main outcome measures: Barthel Index, Philadelphia Geriatric Morale Scale and Caregiver Strain Index. Results: More day centre (23/55) than day hospital patients (6/50) (p <0.001) withdrew from allocated treatment by choice or because of operational difficulties. Both groups improved significantly in functional ability and reduction of care-giver strain by three months but there was no significant difference between groups. The mean improvement in Barthel Index (standard error) for day hospital = +1.5 (0.41) (n = 34) and day centres = +1.5 (0.48) (n = 38). The mean difference (95% confidence interval) between day hospital and day centre was 0 (–1.28, +1.28). Likewise the mean Philadelphia Geriatric Morale Scale improvement for day hospital +1.8 (0.66) (n = 35) and day centres was +0.9 (0.63) (n = 38). The mean difference was –0.88 (–2.7, +0.95). The mean reduction in Caregiver Strain for day hospital was –1.45 (0.5) (n = 23) and day centre was –1.59 (0.47) (n = 27). The difference was –0.14 (1.52,+1.24). (These analyses are all on an intention-to-treat basis.) Conclusion: Whilst the improvement in functional ability and care-giver strain was similar in both groups, day centre rehabilitation was less popular and had practical difficulties. If these difficulties can be overcome the model should be tested elsewhere.

Using the 7-point checklist as a diagnostic aid for pigmented skin lesions in general practice: A diagnostic validation study

BACKGROUND GPs need to recognise significant pigmented skin lesions, given rising UK incidence rates for malignant melanoma. The 7-point checklist (7PCL) has been recommended by NICE (2005) for routine use in UK general practice to identify clinically significant lesions which require urgent referral. AIM To validate the Original and Weighted versions of the 7PCL in the primary care setting. DESIGN AND SETTING Diagnostic validation study, using data from a SIAscopic diagnostic aid randomised controlled trial in eastern England. METHOD Adults presenting in general practice with a pigmented skin lesion that could not be immediately diagnosed as benign were recruited into the trial. Reference standard diagnoses were histology or dermatology expert opinion; 7PCL scores were calculated blinded to the reference diagnosis. A case was defined as a clinically significant lesion for primary care referral to secondary care (total 1436 lesions: 225 cases, 1211 controls); or melanoma (36). RESULTS For diagnosing clinically significant lesions there was a difference between the performance of the Original and Weighted 7PCLs (respectively, area under curve: 0.66, 0.69, difference = 0.03, P<0.001). For the identification of melanoma, similar differences were found. Increasing the Weighted 7PCLs cut-off score from recommended 3 to 4 improved detection of clinically significant lesions in primary care: sensitivity 73.3%, specificity 57.1%, positive predictive value 24.1%, negative predictive value 92.0%, while maintaining high sensitivity of 91.7% and moderate specificity of 53.4% for melanoma. CONCLUSION The Original and Weighted 7PCLs both performed well in a primary care setting to identify clinically significant lesions as well as melanoma. The Weighted 7PCL, with a revised cut-off score of 4 from 3, performs slightly better and could be applied in general practice to support the recognition of clinically significant lesions and therefore the early identification of melanoma.

Protocol for the OUTREACH trial: a randomised trial comparing delivery of cancer systemic therapy in three different settings - patient's home, GP surgery and hospital day unit

BackgroundThe national Cancer Reform Strategy recommends delivering care closer to home whenever possible. Cancer drug treatment has traditionally been administered to patients in specialist hospital-based facilities. Technological developments mean that nowadays, most treatment can be delivered in the out-patient setting. Increasing demand, care quality improvements and patient choice have stimulated interest in delivering some treatment to patients in the community, however, formal evaluation of delivering cancer treatment in different community settings is lacking. This randomised trial compares delivery of cancer treatment in the hospital with delivery in two different community settings: the patients home and general practice (GP) surgeries.Methods/designPatients due to receive a minimum 12 week course of standard intravenous cancer treatment at two hospitals in the Anglia Cancer Network are randomised on a 1:1:1 basis to receive treatment in the hospital day unit (control arm), or their own home, or their choice of one of three neighbouring GP surgeries. Overall patient care, treatment prescribing and clinical review is undertaken according to standard local practice. All treatment is dispensed by the local hospital pharmacy and treatment is delivered by the hospital chemotherapy nurses. At four time points during the 12 week study period, information is collected from patients, nursing staff, primary and secondary care teams to address the primary end point, patient-perceived benefits (using the emotional function domain of the EORTC QLQC30 patient questionnaire), as well as secondary end points: patient satisfaction, safety and health economics.DiscussionThe Outreach trial is the first randomised controlled trial conducted which compares delivery of out-patient based intravenous cancer treatment in two different community settings with standard hospital based treatment. Results of this study may better inform all key stakeholders regarding potential costs and benefits of transferring clinical services from hospital to the community.Trial registration numberISRCTN: ISRCTN66219681

The Huntingdon Day Hospital Trial: secondary outcome measures

Objective: To compare day hospital to day centre rehabilitation using scales to measure mobility, activities of daily living and quality of life. Design: Single blind randomized controlled trial with home assessments at baseline (twice), six weeks and three months. Setting: Mainly rural health district. Day hospital and social services day centres in market towns. Interventions: Day hospital treatment or day centre rehabilitation by a physiotherapist and two health support workers. Main outcome measures: World Health Organization mobility scale scored with and without aid, Nottingham Extended Activities of Daily Living Scale and Nottingham Health Profile. Subjects: One hundred and five physically disabled older patients living at home referred for day hospital rehabilitation or maintenance before discharge from hospital (66) or referred as outpatients (39). Results: At three months there were no statistically significant differences between rehabilitation at day hospital and day centre for any of the outcome measurements. However, there were significant improvements between baseline and three months for the following subscales [mean change per six-week period (95% confidence interval)]: WHO mobility subscale (with aid) – 0.67 (–0.99,–0.35); Nottingham Health Profile mobility subscale –10 (–15.5,–4.5) Nottingham extended ADL mobility subscale +3.08 (1.78,4.37); Nottingham extended ADL leisure subscale +1.66 (0.96,2.36). Conclusion: There were no differences between day hospital and day centre in the outcomes measured. Day rehabilitation appeared to improve functional ability and mobility and scales reflecting these domains deserve further evaluation as outcome measures in this patient group. However, no improvement in quality of life was observed.

Protocol for the ADDITION-Plus study

BackgroundThe increasing prevalence of type 2 diabetes poses both clinical and public health challenges. Cost-effective approaches to prevent progression of the disease in primary care are needed. Evidence suggests that intensive multifactorial interventions including medication and behaviour change can significantly reduce cardiovascular morbidity and mortality among patients with established type 2 diabetes, and that patient education in self-management can improve short-term outcomes. However, existing studies cannot isolate the effects of behavioural interventions promoting self-care from other aspects of intensive primary care management. The ADDITION-Plus trial was designed to address these issues among recently diagnosed patients in primary care over one year.Methods/DesignADDITION-Plus is an explanatory randomised controlled trial of a facilitator-led, theory-based behaviour change intervention tailored to individuals with recently diagnosed type 2 diabetes. 34 practices in the East Anglia region participated. 478 patients with diabetes were individually randomised to receive (i) intensive treatment alone (n = 239), or (ii) intensive treatment plus the facilitator-led individual behaviour change intervention (n = 239). Facilitators taught patients key skills to facilitate change and maintenance of key behaviours (physical activity, dietary change, medication adherence and smoking), including goal setting, action planning, self-monitoring and building habits. The intervention was delivered over one year at the participants surgery and included a one-hour introductory meeting followed by six 30-minute meetings and four brief telephone calls. Primary endpoints are physical activity energy expenditure (assessed by individually calibrated heart rate monitoring and movement sensing), change in objectively measured dietary intake (plasma vitamin C), medication adherence (plasma drug levels), and smoking status (plasma cotinine levels) at one year. We will undertake an intention-to-treat analysis of the effect of the intervention on these measures, an assessment of cost-effectiveness, and analyse predictors of behaviour change in the cohort.DiscussionThe ADDITION-Plus trial will establish the medium-term effectiveness and cost-effectiveness of adding an externally facilitated intervention tailored to support change in multiple behaviours among intensively-treated individuals with recently diagnosed type 2 diabetes in primary care. Results will inform policy recommendations concerning the management of patients early in the course of diabetes. Findings will also improve understanding of the factors influencing change in multiple behaviours, and their association with health outcomes.Trial registrationISRCTN: ISRCTN99175498

Changes in physical activity and modelled cardiovascular risk following diagnosis of diabetes

Diabet. Med. 30, 233–238 (2013)

Who attends a UK diabetes screening programme

Diabet. Med. 27, 995–1003 (2010)