Title: Improving outcomes in Hypertension and Pregnancy through self-monitoring of blood pressure
Funder: Department of Health and Social Care

Abstract: OVERALL BACKGROUND: high blood pressure is a key risk factor for cardiovascular disease, the greatest cause of morbidity and mortality worldwide and a major marker of the development of pre-eclampsia in pregnancy. Currently the detection and treatment of hypertension is sub-optimal, and pre-eclampsia is a leading cause of mortality in pregnancy. Collaborating with patients in the monitoring of blood pressure has the potential to revolutionise the management of both hypertension and pregnancy. Over the last decade I have undertaken a series of studies developing the evidence base for self-monitoring of blood pressure. The proposed programme aims to build on this through my own research teams, collaborating with others and developing colleagues. SUMMARY: over the five years of the proposed Professorship, I will complete a series of programmes of work, so far funded by over £3m of (largely NIHR) grants, aiming to prevent adverse outcomes by improving the management of raised blood pressure in the areas of essential hypertension and pregnancy. The core research elements will comprise an NIHR self-monitoring programme grant and a new stream of work around self-monitoring of blood pressure in pregnancy (NIHR funded pilot). These are supplemented by a series of new collaborations building on my research including development of a web based self-management intervention, implementation of self-monitoring via a CLAHRC collaboration and an individual patient data meta-analysis. A fourth work stream will include the support and development of both specialist colleagues translating their work in primary care (MRC and RfPB funded) plus development of academic primary care through mentorship of juniors, supervision of PhDs and involvement of students. The key financial requests over and above my salary are for a post doc research fellow and two PhD studentships to both assist in the delivery of and provide added value to this significant programme of work. PROGRAMME 1: OPTIMISING THE DIAGNOSIS AND MANAGEMENT OF HYPERTENSION IN PRIMARY CARE THROUGH SELF-MONITORING. Funded NIHR Programme Grant 2012-17, CI McManus, £2m. Aims and objectives: to assess the role of self-monitoring in screening for hypertension, cardiovascular risk assessment and achieving BP targets, arranged across three work streams and twelve research questions. Background: Hypertension is a key risk factor for cardiovascular disease but primary care currently underperforms in its detection and management: around 13% of adults in the UK appear on hypertension registers but only half are controlled to currently accepted targets and at least as many again are undetected. Self-monitoring of hypertension is under-utilised by primary care despite around a third of patients practicing it, due to both a modest evidence base and a lack of implementation. It has the potential to increase detection of hypertension and improve BP control. Collaboration: the programme is a collaboration of NHS Oxfordshire with Primary Care Departments from Oxford, Birmingham and Cambridge. The co-investigators form a multidisciplinary team including social scientists, clinical academics, patients, administrators and a health service manager. Research Plans: this programme of work will provide the evidence to underpin the integration of self-monitoring of blood pressure (BP) into daily practice in primary care. The major areas of study are set out in 3 work streams (WS): WS1.1 Self-monitoring in the screening of hypertension: currently, although around 10% of the general population have self-monitored their own blood pressure there are very few data evaluating the utility of self-screening in the diagnosis of hypertension. This work stream comprises a systematic review of self- screening in hypertension, a survey of the provision of self-screening (eg in pharmacies and GP practice waiting rooms) with adjunct qualitative work to judge current and future practice. This will be followed by the development of a self-screening intervention and pilot testing of that intervention. At the end of WS1.1 we will be in the position to apply for substantive funding for a trial of self-screening in the diagnosis of hypertension or alternatively to show that such a strategy is not feasible. WS1.2 Statistical and health economic modelling: Our group has a wide range of data from previous blood pressure monitoring projects (TASMINH, TASMINH2 and soon TASMIN-SR, BP Eth and HyBET). These will be utilised along with our expertise in both statistical and health economic modelling to re-calibrate both the Framingham and QRISK cardiovascular (CV) risk equations to use self-monitored blood pressure. The next phase will test this re-calibration in practice (using patients recruited in WS1.1) to assess both its effectiveness and cost effectiveness. Statistical modelling using clinic measured blood pressure to predict future BP forms the last part of this WS - preliminary work from the TASMINH2 study suggests that repeated measurement in a clinic setting may allow prediction of self-monitored blood pressures and may capture at least some of the variability seen between visits. One potential application of this may be the ability to detect masked and white coat hypertension on the basis of clinic BP readings. WS1.3 Self-monitoring in the management of hypertension: this work stream is built around an RCT of the management of hypertension in primary care using self-monitored blood pressure. The trial is in two stages with the main outcome being a comparison of General Practitioners adjusting antihypertensive medication using self-monitoring with adjustment using usual (clinic) measurements in terms of achieved blood pressure. There is a second comparison within the self-monitoring group of telemonitoring compared to self-monitoring without telemonitoring aiming to assess whether the additional cost of telemonitoring brings benefit over and above a simpler system. We have been fortunate to gain significant co-funding from our industrial partners Omron of around £100k. The trial is accompanied by a systematic review to ascertain the most appropriate protocol to use for self-management (in collaboration with colleagues from the National Clinical Guideline Centre). A calibration study will assess whether home monitoring equipment currently in use by patients is sufficiently accurate to be used in both the trial and dailypractice. Health economic and qualitative strands complete the work stream providing data on both cost effectiveness and acceptability of the intervention. I lead this programme of work supported by a programme manager and work stream leads. The first studentship (year 1) will work supporting this programme (WS 1.3) and developing a DPhil proposal in parallel. PROGRAMME 2: SELF_MONITORING IN THE DIAGNOSIS OF PRE-ECLAMPSIA. Developmental. Pilot work leading to Programme grant bid in years 2-3 of Professorship(Funded by NSPCR, £237k). CI McManus Aim: This project aims to undertake the preliminary investigation needed to develop a self-monitoring intervention in pregnancy with the aim of applying for substantive funding to trial the intervention on the basis of these results. Background: Raised blood pressure affects 10% of pregnancies worldwide of which a high proportion develop pre-eclampsia. Around 15% of maternal mortality is due to pre-eclampsia so early detection and prevention is paramount. Pre-eclampsia is defined as a combination of a clinic blood pressure measurement of >140/90 mmHg with a PCR > 0.3mg/mmol. Self-monitoring of blood pressure in pregnancy could improve detection whilst empowering women and reducing screening visits but needs to take into account normal changes occurring through the trimesters and be integrated in standard care. To our knowledge, three small scale studies have suggested that self-monitoring is feasible but have not been operationalised in a way conducive to implementation or testing in a trial. Collaboration: This work builds on a successful partnership between the Departments of Primary Care in Oxford and Birmingham and will develop a new collaboration including PPI representation (Saunders), expertise in Obstetric care and Midwifery and research into the diagnosis of pre-eclampsia from London, Birmingham and Oxford. Research Methods: This work stream is developmental and the aim is to gain programme grant / substantive trial funding midway through the five years of the professorship. We will develop pilot work comprising 4 work streams: 2.1 Systematic Review: this will assess current evidence for patient experience of self-monitoring, schedules for self-monitoring of blood pressure in pregnancy and thresholds for the diagnosis of both pre-eclampsia and gestational hypertension. Standard methods for quantitative and qualitative data extraction and analysis will be used with meta-analysis where appropriate. 2.2 Pilot study: field work will be undertaken with a group of 100 women testing performance of self-monitoring in terms of number of measurements needed to provide an appropriate estimate of underlying blood pressure. This will draw upon evidence from the systematic review as well as previous work by our group outside of pregnancy. Eligible women will be at high risk of pre-eclampsia under NICE guidance as this population requires more extensive monitoring and therefore might be expected to gain the most from any new intervention. 2.3 Qualitative study: participating women and clinicians will be interviewed regarding the acceptability and feasibility of the intervention. Participants will be purposively recruited using maximum variation sampling, to ensure that we have the widest possible representation. Results will be incorporated into a forthcoming “healthtalkonline” module. 2.4 Statistical modelling: based on data from the systematic review, from our previous studies of blood pressure monitors, and from the field work, we will estimate the test performance of home blood pressure monitoring in pregnancy, and how this can be optimised; hence, we will develop a monitoring protocol for later study in a randomised trial proposal. Data from all four strands will inform a subsequent application for substantive trial/programme grant funding. At the time of writing (March 2012), we have just received confirmation of funding (£237k) for this pilot work from NSPCR. The second studentship (year 2) will work supporting the development and delivery of this programme of work. PROGRAMME 3: COLLABORATIONS IN SELF-MONITORING/MANAGEMENT. This programme comprises three collaborations which arise directly from our self-monitoring and management portfolio, namely development of a web based self-management intervention, implementation of self-monitoring under the auspices of the Manchester CLAHRC and finally a collaborative individual patient data meta-analysis. Collaboration: each element of programme 3 entails significant collaborations with national and international colleagues and will build on both my national and international reputations. WS3.1 Integrating self-management into a digital intervention: Pilot funded (NSPCR), Programme Grant Application submitted (Yardley lead, McManus Co-App) [National Collaboration] Background and Aims: The TASMINH2 study was the first major trial to show evidence for the efficacy of self-monitoring of blood pressure with self-titration of antihypertensive medications. Whilst the intervention used telemonitoring, the patient information and data collection was paper based and rather unwieldy. Developing a web-based self-management programme (delivered by PC and/or phone) is an obvious next step. This kind of digital intervention (DI) can potentially improve healthcare efficiency by automating routine aspects of patient education, monitoring and support, while improving provision through convenient, 24 hour access to detailed personalised advice, as well as linking patients and professionals. This work aims to develop and test a DI for self-management. Research Plans: A hypertension DI (pilot work funded, NSPCR, collaborators Yardley, Little, Southampton) will be further developed into a potentially cost effective intervention suitable for use in the NHS which will then be trialled. The hypertension DI allows patients and professionals to log onto a secure website to gain access to a range of tools. These include detailed instructions (with videos) for self-monitoring blood pressure (BP); the ability to send email and text message reminders to self-monitor at patient-selected times; facilitation to help patients set goals for lifestyle changes (e.g. salt restriction, weight loss); support to allow patients to enter data (BP, weight, goal achievement) and create progress charts; the provision of automated personalised feedback based on progress; and access to allow health professionals to remotely monitor patient status, goals, and progress. Initial feasibility work will compare theeffects and cost-effectiveness of different forms and levels of support for the hypertension DI and confirm acceptability and feasibility. A substantive trial will establish the cost-effectiveness of the optimal package of hypertension DI. WS3.2 Implementation of self-monitoring. Funded (CLAHRC & Lloyds Pharmacy). [National collaboration] Background and Aims: In collaboration with Dr Pippa Tyrrell and colleagues in the Manchester CLAHRC, this work stream comprises the implementation of self-monitoring of blood pressure in groups of practices in Wigan and Bury. This directly develops and implements work undertaken by myself. The aim is to engage with practices and to implement self-monitoring of blood pressure using validated monitors (provided via a collaboration with Lloyds pharmacy facilitated by myself) for patients with poorly controlled blood pressure. Research Plans: Unlike the rest of the projects in the proposed programme, this WS is entirely about implementation using PDSA (Plan, Do, Study, Act) cycles to test identified models of care using self-monitoring at an individual practice level, learn from each test and refine the model of care in an iterative process. My role on this is to provide expert advice to the steering group, to provide training to practices and their staff and to assist Dr Tyrell in overseeing the project. This is a new paradigm for me and experience gained from WS3.2 will be utilised in my work to help local development of hypertension monitoring in Oxfordshire (see NHS-HEI Partnership below). WS3.3 Individual patient data meta-analysis for self-monitoring. Funded (NIHR InPractice Fellowship Qamar £107k plus NSPCR project funding £50k (CI)) [International Collaboration] Aim: To undertake an IPD of self-monitoring of BP in order to better understand the effects of self-monitoring. Research Plans: We will undertake an individual patient data analysis including randomised trials that have compared self-monitoring of hypertension(with or without other co-interventions) with a control group. Published and unpublished randomised controlled trials will be eligible where self-monitoring of blood pressure formed part of the intervention. Eligible trials will be identified from an allied Cochrane systematic review and meta-analysis undertaken by Qamar (NIHR InPractice fellowship 4.4 below) under my supervision and in collaboration with colleagues from Oxford, Birmingham, Cambridge and Eire. There will be no language restrictions. Standard methods will be employed for data extraction and assessment of methodological quality. A range of data will be requested from included trialists for each trial that meets the inclusion criteria. The primary outcome will be mean difference in systolic and diastolic blood pressure; secondary outcomes will include alternative measures of blood pressure and exploration of causes of heterogeneity including cardiovascular risk profiles of participants, age, sex, persistence with monitoring, measures of health status and anxiety/depression. Authors in the UK and Europe have already agreed to participate and will be invited to contribute to a collaborative meeting to discuss the results and plan the publication in year 1.

Lay abstract: High blood pressure affects over seven million people in the UK and is an important risk factor for heart attack and stroke. In pregnancy, high blood pressure can lead to significant problems for women and their babies. Professor McManus' programme of work evaluates how involving people in monitoring their own blood pressure might lead to better diagnosis and control of high blood pressure in both hypertension and pregnancy.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH