27 research outputs found
Enhanced invitation methods and uptake of health checks in primary care. Rapid randomised controlled trial using electronic health records
Background: A national programme of health checks to identify risk of cardiovascular disease is being rolled out but is encountering difficulties of low uptake. Objective: To evaluate the effectiveness of an enhanced invitation method using the Question-Behaviour Effect (QBE), with or without the offer of a financial incentive to return the QBE questionnaire, at increasing the uptake of health checks. Secondary objectives were to evaluate reasons for low uptake of invitations and to compare case-mix for invited and opportunistic health checks. Trial design: Three-arm randomised trial. Participants: All participants invited for health checks from 18 general practices. Randomisation: Individual participants were randomised. Interventions: i) standard health check invitation only, ii) QBE questionnaire followed by standard invitation; iii) QBE questionnaire with offer of a financial incentive to return the questionnaire, followed by standard invitation. Outcomes: The primary outcome was completion of health check within six months of randomisation. A P value of 0.0167 was used for significance. Case-mix was evaluated for invited and opportunistic health checks. Blinding: Participants were not aware that several types of invitation were in use. The research team were blind to trial arm allocation at outcome data extraction. Results: There were 12,459 participants allocated and health check uptake was evaluated for 12,052 participants for whom outcome data were collected. Health check uptake was: standard invitation, 590 / 4,095 (14.4%); QBE questionnaire, 630 / 3,988 (15.8%); QBE questionnaire and financial incentive, 629 / 3,969 (15.9%). The increase in uptake associated with QBE questionnaire was 1.43% (95% confidence interval -0.12 to 2.97%, P=0.070) and for the QBE questionnaire and offer of financial incentive was 1.52% (-0.03 to 3.07%, P=0.054). The difference in uptake associated with the offer of an incentive to return the QBE questionnaire was -0.01% (-1.59 to 1.58%, P=0.995). During the study, 58% of health check cardiovascular risk assessments did not follow a trial invitation. People who received ‘opportunistic’ health checks had greater odds of ≥10% cardiovascular disease (CVD) risk; adjusted odds ratio 1.70, 95% confidence interval 1.45 to 1.99, P<0.001) compared with invited health checks. Conclusion: Uptake of health checks following an invitation letter is low and is not increased through an enhanced invitation method using the QBE, with or without an incentive. A high proportion of all health checks are performed opportunistically. Participants receiving opportunistic checks are at higher risk of CVD than those responding to standard invitations. Trial registration: Current Controlled Trials ISRCTN42856343
Effectiveness and cost-effectiveness of serum B-type natriuretic peptide testing and monitoring in patients with heart failure in primary and secondary care:an evidence synthesis, cohort study and cost-effectiveness mode
Background: Heart failure (HF) affects around 500,000 people in the UK. HF medications are frequently underprescribed and B-type natriuretic peptide (BNP)-guided therapy may help to optimise treatment. Objective: To evaluate the clinical effectiveness and cost-effectiveness of BNP-guided therapy compared with symptom-guided therapy in HF patients. Design: Systematic review, cohort study and cost-effectiveness model. Setting: A literature review and usual care in the NHS. Participants: (a) HF patients in randomised controlled trials (RCTs) of BNP-guided therapy; and (b) patients having usual care for HF in the NHS. Interventions: Systematic review: BNP-guided therapy or symptom-guided therapy in primary or secondary care. Cohort study: BNP monitored (≥ 6 months’ follow-up and three or more BNP tests and two or more tests per year), BNP tested (≥ 1 tests but not BNP monitored) or never tested. Cost-effectiveness model: BNP-guided therapy in specialist clinics. Main outcome measures: Mortality, hospital admission (all cause and HF related) and adverse events; and quality-adjusted life-years (QALYs) for the cost-effectiveness model. Data sources: Systematic review: Individual participant or aggregate data from eligible RCTs. Cohort study: The Clinical Practice Research Datalink, Hospital Episode Statistics and National Heart Failure Audit (NHFA). Review methods: A systematic literature search (five databases, trial registries, grey literature and reference lists of publications) for published and unpublished RCTs. Results: Five RCTs contributed individual participant data (IPD) and eight RCTs contributed aggregate data (1536 participants were randomised to BNP-guided therapy and 1538 participants were randomised to symptom-guided therapy). For all-cause mortality, the hazard ratio (HR) for BNP-guided therapy was 0.87 [95% confidence interval (CI) 0.73 to 1.04]. Patients who were aged < 75 years or who had heart failure with a reduced ejection fraction (HFrEF) received the most benefit [interactions (p = 0.03): < 75 years vs. ≥ 75 years: HR 0.70 (95% CI 0.53 to 0.92) vs. 1.07 (95% CI 0.84 to 1.37); HFrEF vs. heart failure with a preserved ejection fraction (HFpEF): HR 0.83 (95% CI 0.68 to 1.01) vs. 1.33 (95% CI 0.83 to 2.11)]. In the cohort study, incident HF patients (1 April 2005–31 March 2013) were never tested (n = 13,632), BNP tested (n = 3392) or BNP monitored (n = 71). Median survival was 5 years; all-cause mortality was 141.5 out of 1000 person-years (95% CI 138.5 to 144.6 person-years). All-cause mortality and hospital admission rate were highest in the BNP-monitored group, and median survival among 130,433 NHFA patients (1 January 2007–1 March 2013) was 2.2 years. The admission rate was 1.1 patients per year (interquartile range 0.5–3.5 patients). In the cost-effectiveness model, in patients aged < 75 years with HFrEF or HFpEF, BNP-guided therapy improves median survival (7.98 vs. 6.46 years) with a small QALY gain (5.68 vs. 5.02) but higher lifetime costs (£64,777 vs. £58,139). BNP-guided therapy is cost-effective at a threshold of £20,000 per QALY. Limitations: The limitations of the trial were a lack of IPD for most RCTs and heterogeneous interventions; the inability to identify BNP monitoring confidently, to determine medication doses or to distinguish between HFrEF and HFpEF; the use of a simplified two-state Markov model; a focus on health service costs and a paucity of data on HFpEF patients aged < 75 years and HFrEF patients aged ≥ 75 years. Conclusions: The efficacy of BNP-guided therapy in specialist HF clinics is uncertain. If efficacious, it would be cost-effective for patients aged < 75 years with HFrEF. The evidence reviewed may not apply in the UK because care is delivered differently. Future work: Identify an optimal BNP-monitoring strategy and how to optimise HF management in accordance with guidelines; update the IPD meta-analysis to include the Guiding Evidence Based Therapy Using Biomarker Intensified Treatment (GUIDE-IT) RCT; collect routine long-term outcome data for completed and ongoing RCTs. Trial registration: Current Controlled Trials ISRCTN37248047 and PROSPERO CRD42013005335. Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 40. See the NIHR Journals Library website for further project information. The British Heart Foundation paid for Chris A Rogers’ and Maria Pufulete’s time contributing to the study. Syed Mohiuddin’s time is supported by the NIHR Collaboration for Leadership in Applied Health Research and Care West at University Hospitals Bristol NHS Foundation Trust. Rachel Maishman contributed to the study when she was in receipt of a NIHR Methodology Research Fellowship
Improving the assessment and management of obesity in UK children and adolescents: the PROMISE research programme including a RCT
BackgroundFive linked studies were undertaken to inform identified evidence gaps in the childhood obesity pathway.Objectives(1) To scope the impact of the National Child Measurement Programme (NCMP) (study A). (2) To develop a brief evidence-based electronic assessment and management tool (study B). (3) To develop evidence-based algorithms for identifying the risk of obesity comorbidities (study B). (4) To conduct an efficacy trial of the Healthy Eating and Lifestyle Programme (HELP) (study C). (5) To improve the prescribing of anti-obesity drugs in UK adolescents (study D). (6) To investigate the safety, outcomes and predictors of outcome of adolescent bariatric surgery in the UK (study E).MethodsFive substudies – (1) a parental survey before and after feedback from the National Childhood Measurement Programme, (2) risk algorithm development and piloting of a new primary care management tool, (3) a randomised controlled trial of the Healthy Eating and Lifestyle Programme, (4) quantitative and qualitative studies of anti-obesity drug treatment in adolescents and (5) a prospective clinical audit and cost-effectiveness evaluation of adolescent bariatric surgery in one centre.ResultsStudy A – before the National Childhood Measurement Programme feedback, three-quarters of parents of overweight and obese children did not recognise their child to be overweight. Eighty-seven per cent of parents found the National Childhood Measurement Programme feedback to be helpful. Feedback had positive effects on parental knowledge, perceptions and intentions. Study B – risk estimation models for cardiovascular and psychosocial comorbidities of obesity require further development. An online consultation tool for primary care practitioners is acceptable and feasible. Study C – the Healthy Eating and Lifestyle Programme, when delivered in the community by graduate mental health workers, showed no significant effect on body mass index at 6 months (primary outcome) when compared with enhanced usual care. Study D – anti-obesity drugs appear efficacious in meta-analysis, and their use has expanded rapidly in the last decade. However, the majority of prescriptions are rapidly discontinued after 1–3 months of treatment. Few young people described positive experiences of anti-obesity drugs. Prescribing was rarely compliant with the National Institute for Health and Care Excellence guidance. Study E – bariatric surgery appears safe, effective and highly cost-effective in adolescents in the NHS.Future work and limitationsWork is needed to evaluate behaviour and body mass index change in the National Childhood Measurement Programme more accurately and improve primary care professionals’ understanding of the National Childhood Measurement Programme feedback, update and further evaluate the Computer-Assisted Treatment of CHildren (CATCH) tool, investigate delivery of weight management interventions to young people from deprived backgrounds and those with significant psychological distress and obtain longer-term data on anti-obesity drug use and bariatric surgery outcomes in adolescence.Trial registrationCurrent Controlled Trials ISRCTN99840111.FundingThis project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full inProgramme Grants for Applied Research; Vol. 8, No. 3. See the NIHR Journals Library website for further project information.</jats:sec