Antenatal couples' counselling in Uganda (ACCU): study protocol for a randomised controlled feasibility trial.

BACKGROUND: Common avoidable factors leading to maternal, perinatal and neonatal deaths include lack of birth planning (and delivery in an inappropriate place) and unmet need for contraception. Progress has been slow because routine antenatal care has focused only on women. Yet, in Uganda, many women first want the approval of their husbands. The World Health Organization recommends postpartum family planning (PPFP) as a critical component of health care. The aim of this trial is to test the feasibility of recruiting and retaining participants in a trial of a complex community-based intervention to provide counselling to antenatal couples in Uganda. METHODS: This is a two-group, non-blinded cluster-randomised controlled feasibility trial of a complex intervention. Primary health centres in Uganda will be randomised to receive the intervention or usual care provided by the Ministry of Health. The intervention consists of training village health teams to provide basic counselling to couples at home, encouraging men to accompany their wives to an antenatal clinic, and secondly of training health workers to provide information and counselling to couples at antenatal clinics, to facilitate shared decision-making on the most appropriate place of delivery, and postpartum contraception. We aim to recruit 2 health centres in each arm, each with 10 village health teams, each of whom will aim to recruit 35 pregnant women (a total of 700 women per arm). The village health teams will follow up and collect data on pregnant women in the community up to 12 months after delivery and will directly enter the data using the COSMOS software on a smartphone. DISCUSSION: This intervention addresses two key avoidable factors in maternal, perinatal and neonatal deaths (lack of family planning and inappropriate place of delivery). Determining the acceptability and feasibility of antenatal couples' counselling in this study will inform the design of a fully randomised controlled clinical trial. If this trial demonstrates the feasibility of recruitment and delivery, we will seek funding to conduct a fully powered trial of the complex intervention for improving uptake of birth planning and postpartum family planning in Uganda. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR202102794681952 . Approved on 10 February 2021. ISRCTN Registry ISRCTN97229911. Registered on 23 September 2021.

Mapping the Oxford hip score onto the EQ-5D utility index.

PURPOSE: To assess different mapping methods for the estimation of a group's mean EQ-5D score based on responses to the Oxford hip score (OHS) questionnaire. METHODS: Four models were considered: a) linear regression using total OHS as a continuous regressor; b) linear regression employing responses to the twelve OHS questions as categorical predictors; c) two-part approach combining logistic and linear regression; and d) response mapping. The models were internally validated on the estimation data set, which included OHS and EQ-5D scores for total hip replacements, both before and six months after procedure for 1,759 operations. An external validation was also performed. RESULTS: All models estimated the mean EQ-5D score within 0.005 of an observed health-state utility estimate, ordinary least squares (OLS) continuous being the most accurate and OLS categorical the most consistent. Age, gender and deprivation did not improve the models. More accurate estimations at the individual level were achieved for higher scores of observed OHS and EQ-5D. CONCLUSION: Based on these results, when EQ-5D scores are not available, answers to the OHS questionnaire can be used to estimate a group's mean EQ-5D with a high degree of accuracy.

Paying for costly pharmaceuticals: regulation of new drugs in Australia, England and New Zealand.

The United Kingdom, Australia and New Zealand use different criteria for public funding of pharmaceuticals, but all include estimates of clinical effectiveness and cost-effectiveness. Drug appraisal is done through the National Institute for Health and Clinical Excellence (NICE) in the UK, the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia, and the Pharmaceutical Management Agency (PHARMAC) in NZ. Of the 10 drugs deemed least cost-effective by NICE between 1996 and 2005, all were approved for funding in the UK, six were approved in Australia and five were approved in NZ. Australia and NZ refused funding for drugs for obesity, influenza and growth deficiency. All three countries made exceptions in order to fund drugs of poor cost-effectiveness for some "dread" diseases, but some drugs for less alarming conditions were either not funded or heavily restricted.

Cost effectiveness of nurse led secondary prevention clinics for coronary heart disease in primary care: follow up of a randomised controlled trial.

OBJECTIVE: To establish the cost effectiveness of nurse led secondary prevention clinics for coronary heart disease based on four years' follow up of a randomised controlled trial. DESIGN: Cost effectiveness analysis. SETTING: 19 general practices in north east Scotland. PARTICIPANTS: 1343 patients (673 in intervention group and 670 in control group, as originally randomised) aged under 80 years with a diagnosis of coronary heart disease but without terminal illness or dementia and not housebound. INTERVENTION: Nurse led clinics to promote medical and lifestyle components of secondary prevention. MAIN OUTCOME MEASURES: Costs of clinics; overall costs to health service; and cost per life year and per quality adjusted life year (QALY) gained, expressed as incremental gain in intervention group compared with control group. RESULTS: The cost of the intervention (clinics and drugs) was 136 pounds sterling (254 dollars; 195 euros) per patient higher (1998-9 prices) in the intervention group, but the difference in other NHS costs, although lower for the intervention group, was not statistically significant. Overall, 28 fewer deaths occurred in the intervention group leading to a gain in mean life years per patient of 0.110 and of 0.124 QALYs. The incremental cost per life year saved was 1236 pounds sterling and that per QALY was 1097 pounds sterling. CONCLUSION: Nurse led clinics for the secondary prevention of coronary heart disease in primary care seem to be cost effective compared with most interventions in health care, with the main gains in life years saved.

Home-based versus hospital-based cardiac rehabilitation after myocardial infarction or revascularisation: design and rationale of the Birmingham Rehabilitation Uptake Maximisation Study (BRUM): a randomised controlled trial [ISRCTN72884263].

BACKGROUND: Cardiac rehabilitation following myocardial infarction reduces subsequent mortality, but uptake and adherence to rehabilitation programmes remains poor, particularly among women, the elderly and ethnic minority groups. Evidence of the effectiveness of home-based cardiac rehabilitation remains limited. This trial evaluates the effectiveness and cost-effectiveness of home-based compared to hospital-based cardiac rehabilitation. METHODS/DESIGN: A pragmatic randomised controlled trial of home-based compared with hospital-based cardiac rehabilitation in four hospitals serving a multi-ethnic inner city population in the United Kingdom was designed. The home programme is nurse-facilitated, manual-based using the Heart Manual. The hospital programmes offer comprehensive cardiac rehabilitation in an out-patient setting. PATIENTS: We will randomise 650 adult, English or Punjabi-speaking patients of low-medium risk following myocardial infarction, coronary angioplasty or coronary artery bypass graft who have been referred for cardiac rehabilitation. MAIN OUTCOME MEASURES: Serum cholesterol, smoking cessation, blood pressure, Hospital Anxiety and Depression Score, distance walked on Shuttle walk-test measured at 6, 12 and 24 months. Adherence to the programmes will be estimated using patient self-reports of activity.In-depth interviews with non-attendees and non-adherers will ascertain patient views and the acceptability of the programmes and provide insights about non-attendance and aims to generate a theory of attendance at cardiac rehabilitation. The economic analysis will measure National Health Service costs using resource inputs. Patient costs will be established from the qualitative research, in particular how they affect adherence. DISCUSSION: More data are needed on the role of home-based versus hospital-based cardiac rehabilitation for patients following myocardial infarction and revascularisation, which would be provided by the Birmingham Rehabilitation Uptake Maximisation Study (BRUM) study and has implications for the clinical management of these patients. A novel feature of this study is the inclusion of non-English Punjabi speakers.

SMART: self-management of anticoagulation, a randomised trial [ISRCTN19313375].

BACKGROUND: Oral anticoagulation monitoring has traditionally taken place in secondary care because of the need for a laboratory blood test, the international normalised ratio (INR). The development of reliable near patient testing (NPT) systems for INR estimation has facilitated devolution of testing to primary care. Patient self-management is a logical progression from the primary care model. This study will be the first to randomise non-selected patients in primary care, to either self-management or standard care. METHOD: The study was a multi-centred randomised controlled trial with patients from 49 general practices recruited. Those suitable for inclusion were aged 18 or over, with a long term indication for oral anticoagulation, who had taken warfarin for at least six months. Patients randomised to the intervention arm attended at least two training sessions which were practice-based, 1 week apart. Each patient was assessed on their capability to undertake self management. If considered capable, they were given a near patient INR testing monitor, test strips and quality control material for home testing. Patients managed their own anticoagulation for a period of 12 months and performed their INR test every 2 weeks. Control patients continued with their pre-study care either attending hospital or practice based anticoagulant clinics. DISCUSSION: The methodology used in this trial will overcome concerns from previous trials of selection bias and relevance to the UK health service. The study will give a clearer understanding of the benefits of self-management in terms of clinical and cost effectiveness and patient preference.