Research For Patient Benefit Programme Research Articles

Does a complex intervention by primary care nurses increase walking in older people? Outcomes at 3 and 12 months in the PACE-Lift (Pedometer Accelerometer Consultation Evaluation-Lift) cluster-randomised controlled trial

BackgroundWalking is the commonest physical activity done by older people. Intensity can be light if strolling, and moderate if brisker. We assessed whether a primary care nurse-delivered complex intervention increased walking. MethodsOur study was a parallel two-arm cluster-randomised trial, randomised by household, by researcher using an internet randomisation service. 988 people aged 60–75 years, with no contraindications to increasing their walking, randomly selected from three UK general practices, were invited to participate. 298 people from 250 households were randomised to intervention (150 individuals) or usual care control group (148 individuals). During 3 months, intervention participants received four consultations from their own practice nurse about their physical activity, incorporating behaviour change techniques, feedback on step-counts as measured by pedometer and intensity of physical activity as measured by accelerometer, and an individual physical activity diary and plan. Outcomes were accelerometer-assessed change in average daily step counts over 7 days (primary outcome) and average time spent in physical activity of moderate-to-vigorous intensity weekly (secondary outcome) between baseline, 3 months, and 12 months. Adverse events were recorded by self-administered questionnaire. Assessors were not masked to group allocation. Analysis was by intention to treat, controlling for household clustering (intraclass correlation coefficient=0·004 at 3 months, 0·16 at 12 months). This trial is registered with Current Controlled Trials, ISRCTN42122561. FindingsOutcome data were available for 280 (94%) individuals. Mean baseline average daily step-count was 7388 (SD 2218) in the intervention group and 7453 (2463) in the control group. At 3 months both average daily step-counts and average weekly moderate-to-vigorous physical activity increased significantly more in the intervention than in the control group by 1037 steps per day (95% CI 513–1560) and 66 min per week (36–96), respectively. At 12 months the corresponding differences were 609 (104–1115) and 40 (10–70). Differences in adverse events between intervention and control groups were not significant at either 3 months or 12 months (−4% [95% CI −15 to 7] vs −1% [–13 to 11], respectively). InterpretationIn the PACE-Lift trial, both step-counts and moderate-to-vigorous physical activity increased in people aged 60–75 years at 3 and 12 months. To our knowledge, this is the first trial in older people to show objective increases in moderate-to-vigorous physical activity, and it highlights the value of both accelerometry physical activity assessment and primary care as a setting for phyisical activity interventions. If these differences in physical activity are sustained they should lead to important differences in health outcomes. FundingNational Institute for Health Research Research for Patient Benefit Programme.

The effects of using cognitive behavioural therapy to improve sleep for patients with delusions and hallucinations (the BEST study): study protocol for a randomized controlled trial.

BackgroundPatients with psychosis frequently report difficulties getting or staying asleep (insomnia). Dissatisfaction with sleep is high. Insomnia should be treated in this group, but typically it is not even assessed. Importantly, recent evidence indicates that insomnia triggers and exacerbates delusions and hallucinations. The clinical implication is that if the insomnia is treated then the psychotic symptoms will significantly lessen. In a case series with 15 patients with persecutory delusions resistant to previous treatment this is exactly what we found: cognitive behavioural therapy for insomnia (CBT-I) led to large reductions in both the insomnia and delusions. The clear next step is a pilot randomized controlled test. The clinical aim is to test whether CBT-I can reduce both insomnia and psychotic symptoms. The trial will inform decisions for a definitive large-scale evaluation.Methods/designWe will carry out a randomized controlled trial (the Better Sleep Trial, or the BEST study) with 60 patients with distressing delusions or hallucinations in the context of a schizophrenia spectrum diagnosis. Half of the participants will be randomized to receive CBT-I, in addition to their standard treatment, for up to eight sessions over 12 weeks. The other half will continue with treatment as usual. Blind assessments will take place at 0 weeks, 12 weeks (post-treatment) and 24 weeks (follow-up). The primary outcome hypotheses are that CBT-I added to treatment as usual will improve sleep, delusions and hallucinations compared with only treatment as usual. All main analyses will be carried out at the end of the last follow-up assessments and will be based on the intention-to-treat principle. The trial is funded by the NHS National Institute for Health Research (NIHR) Research for Patient Benefit Programme. Data collection will be complete by the end of 2014.DiscussionThis will be the first controlled test of CBT-I for patients with delusions and hallucinations. It will provide significant evidence for an easily administered intervention that is likely to prove very popular with patients experiencing the difficult-to-treat problems of delusions and hallucinations.Trial registrationCurrent Controlled Trials ISRCTN 33695128

Modelling of future outcomes to estimate the cost effectiveness of interventions related to child and adolescent overweight and obesity

BackgroundChildhood overweight and obesity is a major public health priority. Overweight or obese children are likely to become overweight or obese adults, are likely to be at increased risk of a wide range of chronic diseases (eg, type 2 diabetes, cardiovascular disease, and some cancers), and can have broader effects on lifestyle, health, and wellbeing compared with their peers. A clear need exists for cost-effective interventions or programmes that can help with the problems associated with childhood obesity. However, the conduct of cost-effectiveness analyses (and health technology assessment more broadly) in childhood obesity presents challenges. Translation of measures of effectiveness, for example body-mass index, into the potential effects of interventions on future health outcomes, such as prevention of diabetes, is one such challenge. The current methods available to model future outcomes in this way are limited. We aimed to develop a decision-analytic model to estimate the effect of interventions aimed at childhood overweight and obesity, for use in cost-effectiveness analyses in a public health context. MethodsWe developed a decision-analytic modelling framework using a simple model structure (in the first instance) consisting of three stages: prediction of adult weight status (healthy, overweight, or obese) from childhood weight status; prediction of obesity-related disease or events in adult years (type 2 diabetes, coronary heart disease, stroke, and colorectal cancer); and estimation of the effects of interventions for childhood obesity on prevention of these future events. The model was developed with longitudinal data for the 1958 UK birth cohort in which participants were followed up between ages 11 and 33 years, applying UK90 growth reference standards. Incidence rates for obesity-related health events were calculated on the basis of a 2009 systematic review and meta-analysis. The model was applied to a case study with data from an exploratory trial of a novel, drama-based, school-located obesity intervention, the Healthy Lifestyles Programme (HeLP), to present an example of the potential use of the model in a public health setting. HeLP was delivered to children aged 9–10 years during three school terms, and aimed to deliver a general healthy lifestyle message, seeking to change behaviours in the family, at school, and individually. Three key behaviours were emphasised: decrease in consumption of sweetened fizzy drinks, increase in proportion of healthy snacks to unhealthy snacks, and a reduction in television viewing and other screen-based activities. The empirical or mechanistic element of the model, prediction of adult weight status, was a major challenge, and sensitivity analyses explore the effect of the use of different sources of longitudinal data for prediction of adult weight status. FindingsIn a base-case scenario with a typical control cohort of 1000 children aged 11 years, the model predicted adult weight status at age 33 years, and thereafter an expected minimum of 274 health events (mainly coronary heart disease and type 2 diabetes) in this cohort between age 33 and 63 years (30 year time horizon). The model was used to estimate the expected effect of the HeLP intervention (a change in the distribution of weight status at age 11 years) on the expected number of health events over time, compared with standard practice and applying a third party payer (National Health Service or Personal Social Services) perspective. Outputs from the model can be used to estimate cost-effectiveness based on various input measures and assumptions. The sensitivity of judgments on cost effectiveness to different structural and data inputs were considered. InterpretationFindings suggest a reduction in future obesity-related health effects even when interventions are used in a broad public health context, and when average population effects are small. The model developed for use in cost-effectiveness analyses is a simple first stage, and the parsimonious nature of the model is subject to obvious limitations, but its potential usefulness in a public health decision making context is promising. FundingNIHR Research for Patient Benefit Programme; PenCLAHRC, the NIHR CLAHRC for the Southwest Peninsula.

A systematic review of prevention and intervention strategies for populations at high risk of engaging in violent behaviour: update 2002–8.

It has been estimated that violence accounts for more than 1.6 million deaths worldwide each year and these fatal assaults represent only a fraction of all assaults that actually occur. The problem has widespread consequences for the individual and for the wider society in physical, psychological, social and economic terms. A wide range of pharmacological, psychosocial and organisational interventions have been developed with the aim of addressing the problem. This review was designed to examine the effectiveness of these interventions when they are developed in mental health and criminal justice populations. To update a previous review that examined the evidence base up to 2002 for a wide range of pharmacological, psychosocial and organisational interventions aimed at reducing violence, and to identify the key variables associated with a significant reduction in violence. Nineteen bibliographic databases were searched from January 2002 to April 2008, including PsycINFO (CSA) MEDLINE (Ovid), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Allied and Complementary Medicine Database (AMED), British Nursing Index/Royal College of Nursing, International Bibliography of the Social Sciences (IBSS), Education Resources Information Center (ERIC)/International ERIC, The Cochrane Library (Cochrane reviews, other reviews, clinical trials, methods studies, technology assessments, economic evaluations), Web of Science [Science Citation Index Expanded (SCIE), Social Sciences Citation Index (SSCI), Arts & Humanities Citation Index (A&HCI)]. The assessment was carried out according to accepted procedures for conducting and reporting systematic reviews, including identification of studies, application of inclusion criteria, data extraction and appropriate analysis. Studies were included in meta-analyses (MAs) if they followed a randomised control trial (RCT) design and reported data that could be converted into odds ratios (ORs). For each MA, both a fixed-effects model and a random-effects model were fitted, and both Q statistic and I2 estimates of heterogeneity were performed. A total of 198 studies were identified as meeting the inclusion criteria; of these, 51 (26%) were RCTs. Bivariate analyses exploring possible sources of variance in whether a study reported a statistically significant result or not, identified six variables with a significant association. An outcome was less likely to be positive if the primary intervention was something other than a psychological or pharmacological intervention, the study was conducted in an penal institution, the comparator was another active treatment or treatment as usual and if a between-groups design had been used. An outcome was more likely to be positive if it was conducted with people with a mental disorder. The variation attributable to these variables when added to a binary logistic regression was not large (Cox and Snell R(2) = 0.12), but not insignificant given the small number of variables included. The pooled results of all included RCTs suggested a statistically significant advantage for interventions over the various comparators [OR 0.59, 95% confidence interval (CI) 0.53 to 0.65, fixed effects; OR 0.35, 95% CI 0.26 to 0.49 random effects, 40 studies]. However, there was high heterogeneity {I(2) = 86, Q = 279 [degrees of freedom (df) = 39], p < 0.0001}, indicating the need for caution in interpreting the observed effect. Analysis by subgroups showed that most results followed a similar pattern, with statistically significant advantages of treatments over comparators being suggested in fixed- and/or random-effects models but in the context of large heterogeneity. Three exceptions were atypical antipsychotic drugs [OR 0.21, 95% CI 0.16 to 0.27, fixed effects; OR 0.24, 95% CI 0.14 to 0.43, random effects; 10 studies, I(2) = 72.2, Q = 32.4 (df = 9), p < 0.0001], psychological interventions [OR 0.63, 95% CI 0.48 to 0.83, fixed effects; OR 0.53, 95% CI 0.31 to 0.93, random effects; nine studies, I(2) = 62.1, Q = 21.1 (df = 8), p = 0.007] and cognitive behavioural therapy (CBT) as a primary intervention [OR 0.61, 95% CI 0.42 to 0.88, fixed effects; OR 0.61, 95% CI 0.37 to 0.99, random effects; seven studies, I(2) = 21.6, Q = 7.65 (df = 6), p = 0.26]. The heterogenity of the included studies inhibits both robust MA and the clear application of findings to establishing improvements in clinical practice. Results from this review show small-to-moderate effects for CBT, for all psychological interventions combined, and larger effects for atypical antipsychotic drugs, with relatively low heterogeneity. There is also evidence that interventions targeted at mental health populations, and particularly male groups in community settings, are well supported, as they are more likely to achieve stronger effects than interventions with the other groups. Future work should focus on improving the quality of evidence available and should address the issue of heterogenity in the literature. The National Institute for Health Research Health Technology Assessment programme and the Research for Patient Benefit programme.

P4-12-01: The Breast-Activity and Healthy Eating after Diagnosis (B-AHEAD) Study – A Randomised Comparison of Weight Control Programmes during Adjuvant Treatment.

Abstract Background: Excess weight at diagnosis and weight gain during treatment are linked to increased mortality from breast cancer. Since 60% of breast cancer patients are overweight at diagnosis and 75% gain weight during treatment, weight control should improve outcome but the optimal intervention is unknown. Aim: To compare 3 programmes for weight control after surgery for primary breast cancer. Methods: We have recruited a randomised trial of 2 diet and exercise weight control interventions (1. a community based supervised group programme, 2. a mail and phone programme) compared to standard written advice (control). We are comparing the relative effects of the 3 programmes on body weight and composition (by dual energy x-ray absorptiometry), cardiovascular risk parameters (lipids, blood pressure), a marker of breast cancer prognosis (insulin resistance), fitness and quality of life over the first year after diagnosis. In total 409 women have been randomised (45% of eligible women) and 21 women have left the trial (5.1%), 357 have completed the 6 month assessments, all are due to complete the trial in December 2011. Results: Weight and body fat results at 6 months indicate that the low cost mail and phone programme is equal to the supervised programme and both are significantly superior to written advice, but not in patients receiving chemotherapy. The high uptake and adherence to the trial shows interest and motivation of a significant number of cancer patients to make positive changes to lifestyle at the time of diagnosis. The final trial results will be presented at the December meeting. This abstract presents independent research commissioned by the National Institute for Health Research under the Research for Patient Benefit programme. The views expressed here are those of the authors and not necessarily those of the funding organisations. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P4-12-01.