Protocol for the ADDITION-Plus study: a randomised controlled trial of an individually-tailored behaviour change intervention among people with recently diagnosed type 2 diabetes under intensive UK general practice care.

BACKGROUND: The 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/DESIGN: ADDITION-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 participant's 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. DISCUSSION: The 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.RIGHTS : This article is licensed under the BioMed Central licence at http://www.biomedcentral.com/about/license which is similar to the 'Creative Commons Attribution Licence'. In brief you may : copy, distribute, and display the work; make derivative works; or make commercial use of the work - under the following conditions: the original author must be given credit; for any reuse or distribution, it must be made clear to others what the license terms of this work are

Erratum to: Methods for evaluating medical tests and biomarkers

[This corrects the article DOI: 10.1186/s41512-016-0001-y.]

Evidence synthesis to inform model-based cost-effectiveness evaluations of diagnostic tests: a methodological systematic review of health technology assessments

Background: Evaluations of diagnostic tests are challenging because of the indirect nature of their impact on patient outcomes. Model-based health economic evaluations of tests allow different types of evidence from various sources to be incorporated and enable cost-effectiveness estimates to be made beyond the duration of available study data. To parameterize a health-economic model fully, all the ways a test impacts on patient health must be quantified, including but not limited to diagnostic test accuracy. Methods: We assessed all UK NIHR HTA reports published May 2009-July 2015. Reports were included if they evaluated a diagnostic test, included a model-based health economic evaluation and included a systematic review and meta-analysis of test accuracy. From each eligible report we extracted information on the following topics: 1) what evidence aside from test accuracy was searched for and synthesised, 2) which methods were used to synthesise test accuracy evidence and how did the results inform the economic model, 3) how/whether threshold effects were explored, 4) how the potential dependency between multiple tests in a pathway was accounted for, and 5) for evaluations of tests targeted at the primary care setting, how evidence from differing healthcare settings was incorporated. Results: The bivariate or HSROC model was implemented in 20/22 reports that met all inclusion criteria. Test accuracy data for health economic modelling was obtained from meta-analyses completely in four reports, partially in fourteen reports and not at all in four reports. Only 2/7 reports that used a quantitative test gave clear threshold recommendations. All 22 reports explored the effect of uncertainty in accuracy parameters but most of those that used multiple tests did not allow for dependence between test results. 7/22 tests were potentially suitable for primary care but the majority found limited evidence on test accuracy in primary care settings. Conclusions: The uptake of appropriate meta-analysis methods for synthesising evidence on diagnostic test accuracy in UK NIHR HTAs has improved in recent years. Future research should focus on other evidence requirements for cost-effectiveness assessment, threshold effects for quantitative tests and the impact of multiple diagnostic tests

Erratum to: Methods for evaluating medical tests and biomarkers

[This corrects the article DOI: 10.1186/s41512-016-0001-y.]

Survival and success of maxillary canine autotransplantation: a retrospective investigation

The aim of this study was to evaluate survival and success rates following autotransplantation of permanent maxillary canine teeth. Sixty-three cases of maxillary canine autotransplantation from 49 subjects (mean age at transplantation 21.8 years, range 13-42.1 years) undertaken between 1977 and 2003 were collected as part of an audit project of transplantation success. All maxillary canines had complete root development at the time of transplantation. The sample was divided into two groups, a matched case-control study to compare 27 unilateral transplanted canines with the non-transplanted canine on the contralateral side, and all 63 transplanted canines with no controls. Teeth were assessed clinically using established criteria for success: tooth presence for survival and resorption, mobility, probing pocket depth (PPD), gingival bleeding, vitality, and colour. Radiographic investigation for success assessed internal and external inflammatory resorption (including the amount) bone levels and any signs of pathology. Data were described with descriptive statistics and analytical tests were used to assess frequencies of occurrence. The survival rate was 83 per cent with an average duration of 14.5 years in situ. Thirty-eight per cent of the transplants were deemed successful. There were statistically significant associations between the transplanted and non-transplanted teeth in PPD (P = 0.006), gingival bleeding (P = 0.006), vitality (P = 0.004), and colour (P = 0.002). Autotransplantation of impacted maxillary canines can be successful in the long term and may be indicated in selected cases. Although the rate for complete success in this study was low (no signs of resorption, mobility, and sound periodontal tissues), the survival rate can be considered favourable when evaluating autotransplantation as a treatment option for grossly malpositioned canines with little scope for orthodontic alignment

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

Efficacy of a theory-based behavioural intervention to increase physical activity in an at-risk group in primary care (ProActive UK):A randomised trial

Background: Declining physical activity is associated with a rising burden of global disease. Efforts to reverse this trend have not been successful. We aimed to assess the efficacy of a facilitated behavioural intervention to increase the physical activity of sedentary individuals at familial risk of diabetes. Methods: We enrolled 365 sedentary adults who had a parental history of type 2 diabetes. They were recruited from either diabetes or family history registers at 20 general practice clinics in the UK. Eligible participants were randomly assigned to one of two intervention groups, or to a comparison group. All participants were posted a brief advice leaflet. One intervention group was offered a 1-year behaviour-change programme, to be delivered by trained facilitators in participants' homes, and the other the same programme by telephone. The programme was designed to alter behavioural determinants, as defined by the theory of planned behaviour, and to teach behaviour-change strategies. The principal outcome at 1 year was daytime physical activity, which was objectively measured as a ratio to resting energy expenditure. Analysis was by intention to treat. This study is registered as ISRCTN61323766. Findings: Of 365 patients, we analysed primary endpoints for 321 (88%) for whom we had data after 1 year of follow-up. At 1 year, the physical-activity ratio of participants who received the intervention, by either delivery route, did not differ from the ratio in those who were given a brief advice leaflet. The mean difference in daytime physical-activity ratio, adjusted for baseline, was -0·04 (95% CI -0·16 to 0·08). The physical-activity ratio did not differ between participants who were delivered the intervention face-to-face or by telephone (mean difference -0·05; 95% CI -0·19 to 0·10). Interpretation: A facilitated theory-based behavioural intervention was no more effective than an advice leaflet for promotion of physical activity in an at-risk group; therefore health-care providers should remain cautious about commissioning behavioural programmes into individual preventive health-care services

Erratum to: Methods for evaluating medical tests and biomarkers

The original MEMTAB Abstracts in Diagnostic and Prognostic Research contains the incorrect year on individual abstracts in the PDF [1].“Diagnostic and Prognostic Research 2016” under the correspondence line should therefore have been written as “Diagnostic and Prognostic Research 2017” as the journal did not launch until 2017