Clinical- and cost-effectiveness of a technology-supported and solution-focused intervention (DIALOG+) in treatment of patients with chronic depression-study protocol for a multi-site, cluster randomised controlled trial [TACK].

BACKGROUND: Many with an acute depressive disorder go on to develop chronic depression, despite ongoing care. There are few specifically designed interventions to treat chronic depression. DIALOG+, a technology-assisted intervention based on the principles of solution-focused therapy, may be beneficial. It has been shown to be effective as a treatment for patients with psychotic disorders, especially in regards to increasing quality of life. DIALOG+ was designed to be flexibly applied and not diagnosis-specific, aiming to structure communication and generate a personally-tailored care plan. This cluster randomised controlled trial (RCT) is part of a programme of research to adapt and test DIALOG+ for patients with chronic depression. METHODS: Patients will be eligible for the trial, if they have exhibited symptoms of depression or non-psychotic low mood for at least 2 years, have regular contact with a clinician and have a low subjective quality of life and moderate depressive symptoms. Clinicians, who routinely see eligible patients, will be recruited from a number of sites across NHS England. Clusters will have between 1 and 6 patients per clinician and will be randomised in a 1:1 ratio to either the intervention (DIALOG+) or active control group (treatment as usual + DIALOG scale). Clinicians in the intervention group are trained and asked to deliver the intervention regularly for 12 months. Active control participants receive treatment as usual and are asked to rate their satisfaction with areas of life and treatment on the DIALOG scale at the end of the clinical session. Approximately 112 clinician clusters will be recruited to reach a total patient sample size of 376. Clinical and social outcomes including costs are assessed at baseline and 3, 6 and 12 months post randomisation. The primary outcome will be subjective quality of life at 12 months. DISCUSSION: This definitive multi-site, cluster RCT aims to evaluate the clinical- and cost-effectiveness of DIALOG+ for people with chronic depression. If shown to be effective for this patient population it could be used to improve outcomes of mental health care on a larger scale, ensuring that patients with complex and co-morbid diagnoses can benefit. TRIAL REGISTRATION: ISRCTN11301686 . Registered on 13 Jun 2019.

Measuring change in trials of physical activity interventions: a comparison of self-report questionnaire and accelerometry within the PACE-UP trial.

BACKGROUND: Few trials have compared estimates of change in physical activity (PA) levels using self-reported and objective PA measures when evaluating trial outcomes. The PACE-UP trial offered the opportunity to assess this, using the self-administered International Physical Activity Questionnaire (IPAQ) and waist-worn accelerometry. METHODS: The PACE-UP trial (N = 1023) compared usual care (n = 338) with two pedometer-based walking interventions, by post (n = 339) or with nurse support (n = 346). Participants wore an accelerometer at baseline and 12 months and completed IPAQ for the same 7-day periods. Main outcomes were weekly minutes, all in ≥10 min bouts as per UK PA guidelines of: i) accelerometer moderate-to-vigorous PA (Acc-MVPA) ii) IPAQ moderate+vigorous PA (IPAQ-MVPA) and iii) IPAQ walking (IPAQ-Walk). For each outcome, 12 month values were regressed on baseline to estimate change. RESULTS: Analyses were restricted to 655 (64%) participants who provided data on all outcomes at baseline and 12 months. Both intervention groups significantly increased their accelerometry MVPA minutes/week compared with control: postal group 42 (95% CI 22, 61), nurse group 43 (95% CI 24, 63). IPAQ-Walk minutes/week also increased: postal 57 (95% CI 2, 112), nurse 43 (95% CI -11, 97) but IPAQ-MVPA minutes/week showed non-significant decreases: postal -11 (95% CI -65, 42), nurse -34 (95% CI -87, 19). CONCLUSIONS: Our results demonstrate the necessity of using a questionnaire focussing on the activities being altered, as with IPAQ-Walk questions. Even then, the change in PA was estimated with far less precision than with accelerometry. Accelerometry is preferred to self-report measurement, minimising bias and improving precision when assessing effects of a walking intervention. TRIAL REGISTRATION: ISRCTN, ISRCTN98538934 . Registered 2 March 2012.

Short-term and long-term cost-effectiveness of a pedometer-based exercise intervention in primary care: a within-trial analysis and beyond-trial modelling.

OBJECTIVES: A short-term and long-term cost-effectiveness analysis (CEA) of two pedometer-based walking interventions compared with usual care. DESIGN: (A) Short-term CEA: parallel three-arm cluster randomised trial randomised by household. (B) Long-term CEA: Markov decision model. SETTING: Seven primary care practices in South London, UK. PARTICIPANTS: (A) Short-term CEA: 1023 people (922 households) aged 45-75 years without physical activity (PA) contraindications. (b) Long-term CEA: a cohort of 100 000 people aged 59-88 years. INTERVENTIONS: Pedometers, 12-week walking programmes and PA diaries delivered by post or through three PA consultations with practice nurses. PRIMARY AND SECONDARY OUTCOME MEASURES: Accelerometer-measured change (baseline to 12 months) in average daily step count and time in 10 min bouts of moderate to vigorous PA (MVPA), and EQ-5D-5L quality-adjusted life-years (QALY). METHODS: Resource use costs (£2013/2014) from a National Health Service perspective, presented as incremental cost-effectiveness ratios for each outcome over a 1-year and lifetime horizon, with cost-effectiveness acceptability curves and willingness to pay per QALY. Deterministic and probabilistic sensitivity analyses evaluate uncertainty. RESULTS: (A) Short-term CEA: At 12 months, incremental cost was £3.61 (£109)/min in ≥10 min MVPA bouts for nurse support compared with control (postal group). At £20 000/QALY, the postal group had a 50% chance of being cost saving compared with control. (B) Long-term CEA: The postal group had more QALYs (+759 QALYs, 95% CI 400 to 1247) and lower costs (-£11 million, 95% CI -12 to -10) than control and nurse groups, resulting in an incremental net monetary benefit of £26 million per 100 000 population. Results were sensitive to reporting serious adverse events, excluding health service use, and including all participant costs. CONCLUSIONS: Postal delivery of a pedometer intervention in primary care is cost-effective long term and has a 50% chance of being cost-effective, through resource savings, within 1 year. Further research should ascertain maintenance of the higher levels of PA, and its impact on quality of life and health service use. TRIAL REGISTRATION NUMBER: ISRCTN98538934; Pre-results.

A pedometer-based walking intervention in 45- to 75-year-olds, with and without practice nurse support: the PACE-UP three-arm cluster RCT.

BACKGROUND: Guidelines recommend walking to increase moderate to vigorous physical activity (MVPA) for health benefits. OBJECTIVES: To assess the effectiveness, cost-effectiveness and acceptability of a pedometer-based walking intervention in inactive adults, delivered postally or through dedicated practice nurse physical activity (PA) consultations. DESIGN: Parallel three-arm trial, cluster randomised by household. SETTING: Seven London-based general practices. PARTICIPANTS: A total of 11,015 people without PA contraindications, aged 45-75 years, randomly selected from practices, were invited. A total of 6399 people were non-responders, and 548 people self-reporting achieving PA guidelines were excluded. A total of 1023 people from 922 households were randomised to usual care (n = 338), postal intervention (n = 339) or nurse support (n = 346). The recruitment rate was 10% (1023/10,467). A total of 956 participants (93%) provided outcome data. INTERVENTIONS: Intervention groups received pedometers, 12-week walking programmes advising participants to gradually add '3000 steps in 30 minutes' most days weekly and PA diaries. The nurse group was offered three dedicated PA consultations. MAIN OUTCOME MEASURES: The primary and main secondary outcomes were changes from baseline to 12 months in average daily step counts and time in MVPA (in ≥ 10-minute bouts), respectively, from 7-day accelerometry. Individual resource-use data informed the within-trial economic evaluation and the Markov model for simulating long-term cost-effectiveness. Qualitative evaluations assessed nurse and participant views. A 3-year follow-up was conducted. RESULTS: Baseline average daily step count was 7479 [standard deviation (SD) 2671], average minutes per week in MVPA bouts was 94 minutes (SD 102 minutes) for those randomised. PA increased significantly at 12 months in both intervention groups compared with the control group, with no difference between interventions; additional steps per day were 642 steps [95% confidence interval (CI) 329 to 955 steps] for the postal group and 677 steps (95% CI 365 to 989 steps) for nurse support, and additional MVPA in bouts (minutes per week) was 33 minutes per week (95% CI 17 to 49 minutes per week) for the postal group and 35 minutes per week (95% CI 19 to 51 minutes per week) for nurse support. Intervention groups showed no increase in adverse events. Incremental cost per step was 19p and £3.61 per minute in a ≥ 10-minute MVPA bout for nurse support, whereas the postal group took more steps and cost less than the control group. The postal group had a 50% chance of being cost-effective at a £20,000 per quality-adjusted life-year (QALY) threshold within 1 year and had both lower costs [-£11M (95% CI -£12M to -£10M) per 100,000 population] and more QALYs [759 QALYs gained (95% CI 400 to 1247 QALYs)] than the nurse support and control groups in the long term. Participants and nurses found the interventions acceptable and enjoyable. Three-year follow-up data showed persistent intervention effects (nurse support plus postal vs. control) on steps per day [648 steps (95% CI 272 to 1024 steps)] and MVPA bouts [26 minutes per week (95% CI 8 to 44 minutes per week)]. LIMITATIONS: The 10% recruitment level, with lower levels in Asian and socioeconomically deprived participants, limits the generalisability of the findings. Assessors were unmasked to the group. CONCLUSIONS: A primary care pedometer-based walking intervention in 45- to 75-year-olds increased 12-month step counts by around one-tenth, and time in MVPA bouts by around one-third, with similar effects for the nurse support and postal groups, and persistent 3-year effects. The postal intervention provides cost-effective, long-term quality-of-life benefits. A primary care pedometer intervention delivered by post could help address the public health physical inactivity challenge. FUTURE WORK: Exploring different recruitment strategies to increase uptake. Integrating the Pedometer And Consultation Evaluation-UP (PACE-UP) trial with evolving PA monitoring technologies. TRIAL REGISTRATION: Current Controlled Trials ISRCTN98538934. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 37. See the NIHR Journals Library website for further project information.

Interpreting population reach of a large, successful physical activity trial delivered through primary care.

BACKGROUND: Failure to include socio-economically deprived or ethnic minority groups in physical activity (PA) trials may limit representativeness and could lead to implementation of interventions that then increase health inequalities. Randomised intervention trials often have low recruitment rates and rarely assess recruitment bias. A previous trial by the same team using similar methods recruited 30% of the eligible population but was in an affluent setting with few non-white residents and was limited to those over 60 years of age. METHODS: PACE-UP is a large, effective, population-based walking trial in inactive 45-75 year-olds that recruited through seven London general practices. Anonymised practice demographic data were available for all those invited, enabling investigation of inequalities in trial recruitment. Non-participants were invited to complete a questionnaire. RESULTS: From 10,927 postal invitations, 1150 (10.5%) completed baseline assessment. Participation rate ratios (95% CI), adjusted for age and gender as appropriate, were lower in men 0.59 (0.52, 0.67) than women, in those under 55 compared with those ≥65, 0.60 (0.51, 0.71), in the most deprived quintile compared with the least deprived 0.52 (0.39, 0.70) and in Asian individuals compared with whites 0.62 (0.50, 0.76). Black individuals were equally likely to participate as white individuals. Participation was also associated with having a co-morbidity or some degree of health limitation. The most common reasons for non-participation were considering themselves as being too active or lack of time. CONCLUSIONS: Conducting the trial in this diverse setting reduced overall response, with lower response in socio-economically deprived and Asian sub-groups. Trials with greater reach are likely to be more expensive in terms of recruitment and gains in generalizability need to be balanced with greater costs. Differential uptake of successful trial interventions may increase inequalities in PA levels and should be monitored. TRIAL REGISTRATION: ISRCTN.com ISRCTN98538934 . Registered 2nd March 2012.

Effects of antenatal diet and physical activity on maternal and fetal outcomes: individual patient data meta-analysis and health economic evaluation.

BACKGROUND: Diet- and physical activity-based interventions in pregnancy have the potential to alter maternal and child outcomes. OBJECTIVES: To assess whether or not the effects of diet and lifestyle interventions vary in subgroups of women, based on maternal body mass index (BMI), age, parity, Caucasian ethnicity and underlying medical condition(s), by undertaking an individual patient data (IPD) meta-analysis. We also evaluated the association of gestational weight gain (GWG) with adverse pregnancy outcomes and assessed the cost-effectiveness of the interventions. DATA SOURCES: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects and Health Technology Assessment database were searched from October 2013 to March 2015 (to update a previous search). REVIEW METHODS: Researchers from the International Weight Management in Pregnancy Collaborative Network shared the primary data. For each intervention type and outcome, we performed a two-step IPD random-effects meta-analysis, for all women (except underweight) combined and for each subgroup of interest, to obtain summary estimates of effects and 95% confidence intervals (CIs), and synthesised the differences in effects between subgroups. In the first stage, we fitted a linear regression adjusted for baseline (for continuous outcomes) or a logistic regression model (for binary outcomes) in each study separately; estimates were combined across studies using random-effects meta-analysis models. We quantified the relationship between weight gain and complications, and undertook a decision-analytic model-based economic evaluation to assess the cost-effectiveness of the interventions. RESULTS: Diet and lifestyle interventions reduced GWG by an average of 0.70 kg (95% CI -0.92 to -0.48 kg; 33 studies, 9320 women). The effects on composite maternal outcome [summary odds ratio (OR) 0.90, 95% CI 0.79 to 1.03; 24 studies, 8852 women] and composite fetal/neonatal outcome (summary OR 0.94, 95% CI 0.83 to 1.08; 18 studies, 7981 women) were not significant. The effect did not vary with baseline BMI, age, ethnicity, parity or underlying medical conditions for GWG, and composite maternal and fetal outcomes. Lifestyle interventions reduce Caesarean sections (OR 0.91, 95% CI 0.83 to 0.99), but not other individual maternal outcomes such as gestational diabetes mellitus (OR 0.89, 95% CI 0.72 to 1.10), pre-eclampsia or pregnancy-induced hypertension (OR 0.95, 95% CI 0.78 to 1.16) and preterm birth (OR 0.94, 95% CI 0.78 to 1.13). There was no significant effect on fetal outcomes. The interventions were not cost-effective. GWG, including adherence to the Institute of Medicine-recommended targets, was not associated with a reduction in complications. Predictors of GWG were maternal age (summary estimate -0.10 kg, 95% CI -0.14 to -0.06 kg) and multiparity (summary estimate -0.73 kg, 95% CI -1.24 to -0.23 kg). LIMITATIONS: The findings were limited by the lack of standardisation in the components of intervention, residual heterogeneity in effects across studies for most analyses and the unavailability of IPD in some studies. CONCLUSION: Diet and lifestyle interventions in pregnancy are clinically effective in reducing GWG irrespective of risk factors, with no effects on composite maternal and fetal outcomes. FUTURE WORK: The differential effects of lifestyle interventions on individual pregnancy outcomes need evaluation. STUDY REGISTRATION: This study is registered as PROSPERO CRD42013003804. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Development and validation of Prediction models for Risks of complications in Early-onset Pre-eclampsia (PREP): a prospective cohort study.

BACKGROUND: The prognosis of early-onset pre-eclampsia (before 34 weeks' gestation) is variable. Accurate prediction of complications is required to plan appropriate management in high-risk women. OBJECTIVE: To develop and validate prediction models for outcomes in early-onset pre-eclampsia. DESIGN: Prospective cohort for model development, with validation in two external data sets. SETTING: Model development: 53 obstetric units in the UK. Model transportability: PIERS (Pre-eclampsia Integrated Estimate of RiSk for mothers) and PETRA (Pre-Eclampsia TRial Amsterdam) studies. PARTICIPANTS: Pregnant women with early-onset pre-eclampsia. SAMPLE SIZE: Nine hundred and forty-six women in the model development data set and 850 women (634 in PIERS, 216 in PETRA) in the transportability (external validation) data sets. PREDICTORS: The predictors were identified from systematic reviews of tests to predict complications in pre-eclampsia and were prioritised by Delphi survey. MAIN OUTCOME MEASURES: The primary outcome was the composite of adverse maternal outcomes established using Delphi surveys. The secondary outcome was the composite of fetal and neonatal complications. ANALYSIS: We developed two prediction models: a logistic regression model (PREP-L) to assess the overall risk of any maternal outcome until postnatal discharge and a survival analysis model (PREP-S) to obtain individual risk estimates at daily intervals from diagnosis until 34 weeks. Shrinkage was used to adjust for overoptimism of predictor effects. For internal validation (of the full models in the development data) and external validation (of the reduced models in the transportability data), we computed the ability of the models to discriminate between those with and without poor outcomes (c-statistic), and the agreement between predicted and observed risk (calibration slope). RESULTS: The PREP-L model included maternal age, gestational age at diagnosis, medical history, systolic blood pressure, urine protein-to-creatinine ratio, platelet count, serum urea concentration, oxygen saturation, baseline treatment with antihypertensive drugs and administration of magnesium sulphate. The PREP-S model additionally included exaggerated tendon reflexes and serum alanine aminotransaminase and creatinine concentration. Both models showed good discrimination for maternal complications, with anoptimism-adjusted c-statistic of 0.82 [95% confidence interval (CI) 0.80 to 0.84] for PREP-L and 0.75 (95% CI 0.73 to 0.78) for the PREP-S model in the internal validation. External validation of the reduced PREP-L model showed good performance with a c-statistic of 0.81 (95% CI 0.77 to 0.85) in PIERS and 0.75 (95% CI 0.64 to 0.86) in PETRA cohorts for maternal complications, and calibrated well with slopes of 0.93 (95% CI 0.72 to 1.10) and 0.90 (95% CI 0.48 to 1.32), respectively. In the PIERS data set, the reduced PREP-S model had a c-statistic of 0.71 (95% CI 0.67 to 0.75) and a calibration slope of 0.67 (95% CI 0.56 to 0.79). Low gestational age at diagnosis, high urine protein-to-creatinine ratio, increased serum urea concentration, treatment with antihypertensive drugs, magnesium sulphate, abnormal uterine artery Doppler scan findings and estimated fetal weight below the 10th centile were associated with fetal complications. CONCLUSIONS: The PREP-L model provided individualised risk estimates in early-onset pre-eclampsia to plan management of high- or low-risk individuals. The PREP-S model has the potential to be used as a triage tool for risk assessment. The impacts of the model use on outcomes need further evaluation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN40384046. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Pilot study of a cluster randomised trial of a guided e-learning health promotion intervention for managers based on management standards for the improvement of employee well-being and reduction of sickness absence: GEM Study.

OBJECTIVES: To investigate the feasibility of recruitment, adherence and likely effectiveness of an e-learning intervention for managers to improve employees' well-being and reduce sickness absence. METHODS: The GEM Study (guided e-learning for managers) was a mixed methods pilot cluster randomised trial. Employees were recruited from four mental health services prior to randomising three services to the intervention and one to no-intervention control. Intervention managers received a facilitated e-learning programme on work-related stress. Main outcomes were Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), 12-item GHQ and sickness absence <21 days from human resources. 35 in-depth interviews were undertaken with key informants, managers and employees, and additional observational data collected. RESULTS: 424 of 649 (65%) employees approached consented, of whom 350 provided WEMWBS at baseline and 284 at follow-up; 41 managers out of 49 were recruited from the three intervention clusters and 21 adhered to the intervention. WEMWBS scores fell from 50.4-49.0 in the control (n=59) and 51.0-49.9 in the intervention (n=225), giving an intervention effect of 0.5 (95% CI -3.2 to 4.2). 120/225 intervention employees had a manager who was adherent to the intervention. HR data on sickness absence (n=393) showed no evidence of effect. There were no effects on GHQ score or work characteristics. Online quiz knowledge scores increased across the study in adherent managers. Qualitative data provided a rich picture of the context within which the intervention took place and managers' and employees' experiences of it. CONCLUSIONS: A small benefit from the intervention on well-being was explained by the mixed methods approach, implicating a low intervention uptake by managers and suggesting that education alone may be insufficient. A full trial of the guided e-learning intervention and economic evaluation is feasible. Future research should include more active encouragement of manager motivation, reflection and behaviour change. TRIAL REGISTRATION NUMBER: ISRCTN58661009.

Numbers are not the whole story: a qualitative exploration of barriers and facilitators to increased physical activity in a primary care based walking intervention.

BACKGROUND: The majority of mid-life and older adults in the UK are not achieving recommended physical activity levels and inactivity is associated with many health problems. Walking is a safe, appropriate exercise. The PACE-UP trial sought to increase walking through the structured use of a pedometer and handbook, with and without support from a practice nurse trained in behaviour change techniques (BCTs). Understanding barriers and facilitators to engagement with a primary care based physical activity intervention is essential for future trials and programmes. METHODS: We conducted semi-structured telephone interviews using a topic guide with purposive samples of participants who did and did not increase their walking from both intervention groups. Interviews were audio-recorded, transcribed and coded independently by researchers prior to performing a thematic analysis. Responsiveness to the specific BCTs used was also analysed. RESULTS: Forty-three trial participants were interviewed in early 2014. Almost all felt they had benefitted, irrespective of their change in step-count, and that primary care was an appropriate setting.Important facilitators included a desire for a healthy lifestyle, improved physical health, enjoyment of walking in the local environment, having a flexible routine allowing for an increase in walking, appropriate self and external monitoring and support from others.Important barriers included physical health problems, an inflexible routine, work and other commitments, the weather and a mistrust of the monitoring equipment.BCTs that were reported to have the most impact included: providing information about behaviour-health link; prompting self-monitoring and review of goals and outcomes; providing feedback; providing specific information about how to increase walking; planning social support/change; and relapse prevention. Rewards were unhelpful. CONCLUSIONS: Despite our expectation that there would be a difference between the experiences of those who did and did not objectively increase their walking, we found that most participants considered themselves to have succeeded in the trial and benefitted from taking part. Barriers and facilitators were similar across demographic groups and trial outcomes. Findings indicated several BCTs on which PA trial and programme planners could focus efforts with the expectation of greatest impact as well as strong support for primary care as an appropriate venue. TRIAL REGISTRATION: ISRCTN98538934.

Study protocol: differential effects of diet and physical activity based interventions in pregnancy on maternal and fetal outcomes--individual patient data (IPD) meta-analysis and health economic evaluation.

BACKGROUND: Pregnant women who gain excess weight are at risk of complications during pregnancy and in the long term. Interventions based on diet and physical activity minimise gestational weight gain with varied effect on clinical outcomes. The effect of interventions on varied groups of women based on body mass index, age, ethnicity, socioeconomic status, parity, and underlying medical conditions is not clear. Our individual patient data (IPD) meta-analysis of randomised trials will assess the differential effect of diet- and physical activity-based interventions on maternal weight gain and pregnancy outcomes in clinically relevant subgroups of women. METHODS/DESIGN: Randomised trials on diet and physical activity in pregnancy will be identified by searching the following databases: MEDLINE, EMBASE, BIOSIS, LILACS, Pascal, Science Citation Index, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, and Health Technology Assessment Database. Primary researchers of the identified trials are invited to join the International Weight Management in Pregnancy Collaborative Network and share their individual patient data. We will reanalyse each study separately and confirm the findings with the original authors. Then, for each intervention type and outcome, we will perform as appropriate either a one-step or a two-step IPD meta-analysis to obtain summary estimates of effects and 95% confidence intervals, for all women combined and for each subgroup of interest. The primary outcomes are gestational weight gain and composite adverse maternal and fetal outcomes. The difference in effects between subgroups will be estimated and between-study heterogeneity suitably quantified and explored. The potential for publication bias and availability bias in the IPD obtained will be investigated. We will conduct a model-based economic evaluation to assess the cost effectiveness of the interventions to manage weight gain in pregnancy and undertake a value of information analysis to inform future research. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2013: CRD42013003804.

PACE-UP (Pedometer and consultation evaluation--UP)--a pedometer-based walking intervention with and without practice nurse support in primary care patients aged 45-75 years: study protocol for a randomised controlled trial.

BACKGROUND: Most adults do not achieve the 150 minutes weekly of at least moderate intensity activity recommended for health. Adults' most common physical activity (PA) is walking, light intensity if strolling, moderate if brisker. Pedometers can increase walking; however, most trials have been short-term, have combined pedometer and support effects, and have not reported PA intensity. This trial will investigate whether pedometers, with or without nurse support, can help less active 45-75 year olds to increase their PA over 12 months. DESIGN: Primary care-based 3-arm randomized controlled trial with 12-month follow-up and health economic and qualitative evaluations. PARTICIPANTS: Less active 45-75 year olds (n = 993) will be recruited by post from six South West London general practices, maximum of two per household and households randomised into three groups. Step-count and time spent at different PA intensities will be assessed for 7 days at baseline, 3 and 12 months by accelerometer. Questionnaires and anthropometric assessments will be completed. INTERVENTION: The pedometer-alone group will be posted a pedometer (Yamax Digi-Walker SW-200), handbook and diary detailing a 12-week pedometer-based walking programme, using targets from their baseline assessment. The pedometer-plus-support group will additionally receive three practice nurse PA consultations. The handbook, diary and consultations include behaviour change techniques (e.g., self-monitoring, goal-setting, relapse prevention planning). The control group will receive usual care. OUTCOMES: Changes in average daily step-count (primary outcome), time spent sedentary and in at least moderate intensity PA weekly at 12 months, measured by accelerometry. Other outcomes include change in body mass index, body fat, self-reported PA, quality of life, mood and adverse events. Cost-effectiveness will be assessed by the incremental cost of the intervention to the National Health Service and incremental cost per change in step-count and per quality adjusted life year. Qualitative evaluations will explore reasons for trial non-participation and the interventions' acceptability. DISCUSSION: The PACE-UP trial will determine the effectiveness and cost-effectiveness of a pedometer-based walking intervention delivered by post or practice nurse to less active primary care patients aged 45-75 years old. Approaches to minimise bias and challenges anticipated in delivery will be discussed. TRIAL REGISTRATION: ISRCTN98538934.

Home blood pressure monitoring in hypertensive stroke patients: a prospective cohort study following a randomized controlled trial.

BACKGROUND: We found little data on long-term home blood pressure monitoring in stroke patients. OBJECTIVES: After completing a 12-month trial of home monitoring in hypertensive stroke patients, we investigated the following: 1. The proportion of 118 control patients offered a monitor at the end of the trial without nurse support who used it at least monthly after 6 months. 2. The proportion of 119 intervention patients continuing to use their monitor monthly after 18 months. 3. Possible predictors of monitoring weekly in the first month after receiving a monitor: age, gender, ethnicity, cognition, anxiety, disability, ability to monitor blood pressure unaided and smoking. METHODS: Participants (mean age 71, 34% with disability and 21% from ethnic minorities) were surveyed 1 and/or 6 months after the trial ended by postal and/or telephone questionnaire. RESULTS: Of 237 potential participants, 53 (22%) declined, 16 (6%) were lost and 9 (4%) died during follow-up. Overall, reported monthly use of the monitor without nurse support was 47% [54/114, 95% confidence interval (CI) 38.2-56.5] at 6 months and 50% (57/114, 95% CI 40.8-59.2) at 18 months. Participants who monitored weekly after 1 month were more likely than the remainder to have no disability [Rankin score ≤ 1; relative risk (RR) 1.2; 95% CI 1.0-1.5] and low anxiety levels (FEAR score = 0; RR 1.5; 95% CI 1.1-2.0). CONCLUSION: Around half of hypertensive stroke patients offered a blood pressure monitor but no support continued to use it after 6 and 18 months. Monitoring in the first month was common in those who were not anxious or disabled.

Randomised controlled trial of a complex intervention by primary care nurses to increase walking in patients aged 60-74 years: protocol of the PACE-Lift (Pedometer Accelerometer Consultation Evaluation - Lift) trial.

BACKGROUND: Physical activity is essential for older peoples' physical and mental health and for maintaining independence. Guidelines recommend at least 150 minutes weekly, of at least moderate intensity physical activity, with activity on most days. Older people's most common physical activity is walking, light intensity if strolling, moderate if brisker. Less than 20% of United Kingdom 65-74 year olds report achieving the guidelines, despite most being able to. Effective behaviour change techniques include strategies such as goal setting, self-monitoring, building self-efficacy and relapse prevention. Primary care physical activity consultations allow individual tailoring of advice. Pedometers measure step-counts and accelerometers measure physical activity intensity. This protocol describes an innovative intervention to increase walking in older people, incorporating pedometer and accelerometer feedback within a primary care nurse physical activity consultation, using behaviour change techniques. DESIGN: Randomised controlled trial with intervention and control (usual care) arms plus process and qualitative evaluations. PARTICIPANTS: 300 people aged 60-74 years registered with 3 general practices within Oxfordshire and Berkshire West primary care trusts, able to walk outside and with no restrictions to increasing their physical activity. INTERVENTION: 3 month pedometer and accelerometer based intervention supported by practice nurse physical activity consultations. Four consultations based on behaviour change techniques, physical activity diary, pedometer average daily steps and accelerometer feedback on physical activity intensity. Individual physical activity plans based on increasing walking and other existing physical activity will be produced. OUTCOMES: Change in average daily steps (primary outcome) and average time spent in at least moderate intensity physical activity weekly (secondary outcome) at 3 months and 12 months, assessed by accelerometry. Other outcomes include quality of life, mood, exercise self-efficacy, injuries. Qualitative evaluations will explore reasons for trial non-participation, the intervention's acceptability to patients and nurses and factors enhancing or acting as barriers for older people in increasing their physical activity levels. DISCUSSION: The PACE-Lift trial will determine the feasibility and efficacy of an intervention for increasing physical activity among older primary care patients. Steps taken to minimise bias and the challenges anticipated will be discussed. Word count 341. TRIAL REGISTRATION NUMBER: ISRCTN42122561.

How reliable are stroke patients' reports of their numbers of general practice consultations over 12 months?

BACKGROUND: Data on primary health care use are frequently used in economic evaluations. However, it is unclear how patient self-reports of their number of consultations with their general practitioner (GP) relate to actual consultations in the electronic records. These data are crucial if self-reports are used to conduct economic evaluations. OBJECTIVES: To report the accuracy of stroke patients' self-reports of their number of primary care consultations over a 12-month period by comparison with practice-held electronic records. We also recorded the number of contacts required to collect service use data from the practices. METHODS: We contacted 65 practices requesting electronic consultation records over 12 months for 115 stroke patients who took part in a trial of home blood pressure monitoring. Consultation rates from the electronic records were compared with patients' self-reported number of consultations from a questionnaire covering the same period. RESULTS: Fifty-one practices (78%) responded. Patients' questionnaires (n = 83) reported a mean of 5.7 consultations with their GP per year compared with 7.2 in the electronic records (difference 1.6, 95% confidence interval 0.5-2.7, P < 0.01). The mean time taken to obtain records from practices was 6 weeks. CONCLUSIONS: Patients modestly under-reported the number of consultations they had with a GP. Obtaining patient records from practices required more effort than obtaining information from patient questionnaires at the same time as assessing main trial outcomes. If patient self-reports of health care usage are used in economic evaluations in primary care, researchers should consider validating a sample against electronic records.

What is the cost of pelvic inflammatory disease and how much could be prevented by screening for chlamydia trachomatis? Cost analysis of the Prevention of Pelvic Infection (POPI) trial.

OBJECTIVES: To describe healthcare settings attended by women with clinical pelvic inflammatory disease (PID), to calculate the cost of a PID episode and to estimate how many cases could be prevented in London annually at current chlamydia screening levels. METHODS: An ethnically diverse sample of 2259 16-24 year old, sexually active, female London students were recruited to a chlamydia screening trial in 2004-2006 of whom 94% (2115) were followed up after 12 months for incidence of PID. A cost analysis examined healthcare settings attended by women with PID, the cost of an episode of PID and the number of cases of PID in London due to untreated chlamydia at baseline that could be prevented per year at 2009 annual screening levels. RESULTS: Of 35 PID cases, 17 (47%) first presented in general practice, 15 (42%) at a genitourinary medicine clinic, two elsewhere and one was admitted to hospital. The average number of consultations for a PID episode was 2.0 (range 1-4) and the average cost was £163 (range £29-960). Assuming 414,345 sexually active women aged 16-24 in London, 6% chlamydia prevalence at baseline and a 7.3% difference in PID rates between screened and unscreened chlamydia positives, 391 (95% CI--44 to 882) cases of chlamydia-associated PID costing £63,733 could be prevented each year in London at 21.5% 2009 annual screening levels. CONCLUSIONS: Most women with PID were managed in the community. The number and cost of PID cases prevented by a single annual chlamydia screen is low suggesting that cost effectiveness may depend mainly on the prevention of long-term sequelae.

Assessment of GFR by four methods in adults in Ashanti, Ghana: the need for an eGFR equation for lean African populations.

BACKGROUND: Equations for estimating glomerular filtration rate (GFR) have not been validated in Sub-Saharan African populations, and data on GFR are few. METHODS: GFR by creatinine clearance (Ccr) using 24-hour urine collections and estimated GFR (eGFR) using the four-variable Modification of Diet in Renal Disease (MDRD-4)[creatinine calibrated to isotope dilution mass spectrometry (IDMS) standard], Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Cockcroft-Gault equations were obtained in Ghanaians aged 40-75. The population comprised 1013 inhabitants in 12 villages; 944 provided a serum creatinine and two 24-hour urines. The mean weight was 54.4 kg; mean body mass index was 21.1 kg/m(2). RESULTS: Mean GFR by Ccr was 84.1 ml/min/1.73 m(2); 86.8% of participants had a GFR of >/=60 ml/min/1.73 m(2). Mean MDRD-4 eGFR was 102.3 ml/min/1.73 m(2) (difference vs. Ccr, 18.2: 95% CI: 16.8-19.5); when the factor for black race was omitted, the value (mean 84.6 ml/min/1.73 m(2)) was close to Ccr. Mean CKD-EPI eGFR was 103.1 ml/min/1.73 m(2), and 89.4 ml/min/1.73 m(2) when the factor for race was omitted. The Cockcroft-Gault equation underestimated GFR compared with Ccr by 9.4 ml/min/1.73 m(2) (CI: 8.3-10.6); particularly in older age groups. GFR by Ccr, and eGFR by MDRD-4, CKD-EPI and Cockcroft-Gault showed falls with age: MDRD-4 5.5, Ccr 7.7, CKD-EPI 8.8 and Cockcroft-Gault 11.0 ml/min/1.73 m(2)/10 years. The percentage of individuals identified with CKD stages 3-5 depended on the method used: MDRD-4 1.6% (7.2 % without factor for black race; CKD-EPI 1.7% (4.7% without factor for black race), Ccr 13.2% and Cockcroft-Gault 21.0%. CONCLUSIONS: Mean eGFR by both MDRD-4 and CKD-EPI was considerably higher than GFR by Ccr and Cockcroft-Gault, a difference that may be attributable to leanness. MDRD-4 appeared to underestimate the fall in GFR with age compared with the three other measurements; the fall with CKD-EPI without the adjustment for race was the closest to that of Ccr. An equation tailored specifically to the needs of the lean populations of Africa is urgently needed. For the present, the CKD-EPI equation without the adjustment for black race appears to be the most useful.

Rural and semi-urban differences in salt intake, and its dietary sources, in Ashanti, West Africa.

OBJECTIVES: To provide a socioeconomic profile of rural and semi-urban settings in Ashanti, West Africa and to investigate the relationship between urbanization and sources of salt in the diet. SETTING: 12 villages (6 rural, 6 semi-urban) participating in a cluster randomized controlled trial of a health promotion in the Ashanti region of Ghana. PARTICIPANTS: 1013 adult men (N = 385) and women (N = 628), aged 40-75. METHOD: Between June 2001 and June 2002, participants completed a detailed questionnaire on demography, occupation and education, housing, radio and television use, personal and family medical history, drug therapy, smoking, alcohol consumption, and diet. RESULTS: 532 subjects lived in semi-urban and 481 in rural communities. Ninety-two percent of the participants were of the Ashanti tribe and 94% spoke Twi. The semi-urban villages were closer to Kumasi, the second largest city in Ghana, had larger population (1727 vs 1100 people) and household sizes (14.6 vs 8.8 persons per household; P < .001), had fewer farmers (53% vs 81%; P < .001) and more traders (22% vs 7%; P < .001), and had more homes with electricity (81% vs 17%; P < .001) and piped water (28% vs 0.2%; P < .05). Semi-urban villagers had higher systolic blood pressure than rural villagers (129 vs 121 mm Hg difference 8 mm Hg [95% CI 5-11]; P < .001). Salt is almost invariably added to food in cooking (98%), and salted foods such as fish and meat are eaten in both communities. Salt is often added at the table (52%), more often in rural villages than in semi-urban settings (59% vs 45%; P < .01), although the total salt consumed as measured by urinary sodium was similar (99 vs 103 mmol/day). Potassium levels were higher in rural villages (58 vs 40 mmol/day difference 18 mmol/day [95% CI 11-26]; P < .001). CONCLUSIONS: In this mainly farming community were clear differences in housing, population structure, and blood pressure between rural and semi-urban communities. While no significant differences were in the amount of salt consumed, the sources of salt differed between rural and semi-urban settings. Finally, rural villagers ate more potassium than semi-urban participants.

Prevalence, detection, management, and control of hypertension in Ashanti, West Africa.

Hypertension and stroke are important threats to the health of adults in sub-Saharan Africa. Nevertheless, detection of hypertension is haphazard and stroke prevention targets are currently unattainable. Prevalence, detection, management, and control of hypertension were assessed in 1013 men (n=385) and women (n=628), both aged 55 [SD 11] years, living in 12 villages in Ashanti, Ghana. Five hundred thirty two lived in semi-urban and 481 in rural villages. The participants underwent measurements of height, weight, and blood pressure (BP) and answered a detailed questionnaire. Hypertension was defined as BP > or =140 and/or > or =90 mm Hg or being on drug therapy. Women were heavier than men. Participants in semi-urban areas were heavier and had higher BP (129/76 [26/14] versus 121/72 [25/13] mm Hg; P<0.001 for both) than in rural areas. Prevalence of hypertension was 28.7% overall and comparable in men and women, but higher in semi-urban villages (32.9% [95% CI 28.9 to 37.1] versus 24.1% [20.4 to 28.2]), and increased with age. Detection rate was lower in men than women (13.9% versus 27.3%; P=0.007). Treatment and control rates were low in both groups (7.8% and 4.4% versus 13.6% and 1.7%). Detection, treatment, and control rates were higher in semi-urban (25.7%, 14.3%, and 3.4%) than in rural villages (16.4%, 6.9%, and 1.7%). Hypertension is common in adults in central Ghana, particularly in urban areas. Detection rates are suboptimal in both men and women, especially in rural areas. Adequate treatment of high BP is at a very low level. There is an urgent need for preventive strategies on hypertension control in Ghana.