Blood pressure self-monitoring in pregnancy: examining feasibility in a prospective cohort study

Background: Raised blood pressure (BP) affects approximately 10% of pregnancies worldwide, and a high proportion of affected women develop pre-eclampsia. This study aimed to evaluate the feasibility of self-monitoring of BP in pregnancy in women at higher risk of pre-eclampsia. Methods: This prospective cohort study of self-monitoring BP in pregnancy was carried out in two hospital trusts in Birmingham and Oxford and thirteen primary care practices in Oxfordshire. Eligible women were those defined by the UK National Institute for Health and Care Excellence (NICE) guidelines as at higher risk of pre-eclampsia. A total of 201 participants were recruited between 12 and 16 weeks of pregnancy and were asked to take two BP readings twice daily three times a week through their pregnancy. Primary outcomes were recruitment, retention and persistence of self-monitoring. Study recruitment and retention were analysed with descriptive statistics. Survival analysis was used to evaluate the persistence of self-monitoring and the performance of self-monitoring in the early detection of gestational hypertension, compared to clinic BP monitoring. Secondary outcomes were the mean clinic and self-monitored BP readings and the performance of self-monitoring in the detection of gestational hypertension and pre-eclampsia compared to clinic BP. Results: Of 201 women recruited, 161 (80%) remained in the study at 36 weeks or to the end of their pregnancy, 162 (81%) provided any home readings suitable for analysis, 148 (74%) continued to self-monitor at 20 weeks and 107 (66%) at 36 weeks. Self-monitored readings were similar in value to contemporaneous matched clinic readings for both systolic and diastolic BP. Of the 23 who developed gestational hypertension or pre-eclampsia and self-monitored, 9(39%) had a raised home BP prior to a raised clinic BP. Conclusions: Self-monitoring of BP in pregnancy is feasible and has potential to be useful in the early detection of gestational hypertensive disorders but maintaining self-monitoring throughout pregnancy requires support and probably enhanced training

Patients’ and clinicians’ views on the optimum schedules for self-monitoring of blood pressure: a qualitative focus group and interview study

BACKGROUND: Self-monitoring of blood pressure is common but guidance on how it should be carried out varies and it is currently unclear how such guidance is viewed. AIM: To explore patients' and healthcare professionals' (HCPs) views and experiences of the use of different self-monitoring regimens to determine what is acceptable and feasible, and to inform future recommendations. DESIGN AND SETTING: Thirteen focus groups and four HCP interviews were held, with a total of 66 participants (41 patients and 25 HCPs) from primary and secondary care with and without experience of self-monitoring. METHOD: Standard and shortened self-monitoring protocols were both considered. Focus groups and interviews were recorded, transcribed verbatim, and analysed using the constant comparative method. RESULTS: Patients generally supported structured schedules but with sufficient flexibility to allow adaptation to individual routine. They preferred a shorter (3-day) schedule to longer (7-day) regimens. Although HCPs could describe benefits for patients of using a schedule, they were reluctant to recommend a specific schedule. Concerns surrounded the use of different schedules for diagnosis and subsequent monitoring. Appropriate education was seen as vital by all participants to enable a self-monitoring schedule to be followed at home. CONCLUSION: There is not a 'one size fits all approach' to developing the optimum protocol from the perspective of users and those implementing it. An approach whereby patients are asked to complete the minimum number of readings required for accurate blood pressure estimation in a flexible manner seems most likely to succeed. Informative advice and guidance should incorporate such flexibility for patients and professionals alike

Cost-effectiveness of telemonitoring and self-monitoring of blood pressure for antihypertensive titration in primary care (TASMINH4)

The use of self-monitoring of Blood Pressure (BP), with or without telemonitoring, to guide therapy decisions by physicians for patients with hypertension has been recently demonstrated to reduce BP compared with using clinic monitoring (usual care). However, both the cost-effectiveness of these strategies compared to usual care, and whether the additional benefit of telemonitoring compared with self-monitoring alone could be considered value for money, are unknown. This study assessed the cost-effectiveness of physician titration of antihypertensive medication using self-monitored BP, with or without telemonitoring, to make hypertension treatment decisions in primary care compared with usual care. A Markov patient-level simulation model was developed taking a UK Health Service/Personal Social Services perspective. The model adopted a lifetime time horizon with six month time cycles. At a willingness to pay of £20,000 per Quality Adjusted Life Year, self-monitoring plus telemonitoring was the most cost-effective strategy (£17,424 per QALY gained) compared with usual care or self-monitoring alone (posting the results to the physician). However, deterministic sensitivity analysis showed that self-monitoring alone became the most cost-effective option when changing key assumptions around long term effectiveness and time horizon. Overall, probabilistic sensitivity analysis suggested that self-monitoring regardless of transmission modality was very likely to be cost-effective compared with usual care (89% probability of cost-effectiveness at £20,000/QALY), with high uncertainty as to whether telemonitoring or self-monitoring alone was the most cost-effective option. Self-monitoring in clinical practice is cost-effective and likely to lead to reduced cardiovascular mortality and morbidity

Self-monitoring blood pressure in pregnancy: evaluation of women’s experiences of the BUMP trials

Background: The COVID-19 pandemic accelerated the adoption of remote care, or telemedicine, in many clinical areas including maternity care. One component of remote care, the use of self-monitoring of blood pressure in pregnancy, could form a key component in post-pandemic care pathways. The BUMP trials evaluated a self-monitoring of blood pressure intervention in addition to usual care, testing whether it improved detection or control of hypertension for pregnant people at risk of hypertension or with hypertension during pregnancy. This paper reports the qualitative evaluation which aimed to understand how the intervention worked, the perspectives of participants in the trials, and, crucially, those who declined to participate. Methods: The BUMP trials were conducted between November 2018 and May 2020. Thirty-nine in-depth qualitative interviews were carried out with a diverse sample of pregnant women invited to participate in the BUMP trials across five maternity units in England. Results: Self-monitoring of blood pressure in the BUMP trials was reassuring, acceptable, and convenient and sometimes alerted women to raised BP. While empowering, taking a series of self-monitored readings also introduced uncertainty and new responsibility. Some declined to participate due to a range of concerns. In the intervention arm, the performance of the BUMP intervention may have been impacted by women’s selective or delayed reporting of raised readings and repeated testing in pursuit of normal BP readings. In the usual care arm, more women were already self-monitoring their blood pressure than expected. Conclusions: The BUMP trials did not find that among pregnant individuals at higher risk of preeclampsia, blood pressure self-monitoring with telemonitoring led to significantly earlier clinic-based detection of hypertension nor improved management of blood pressure. The findings from this study help us understand the role that self-monitoring of blood pressure can play in maternity care pathways. As maternity services consider the balance between face-to-face and remote consultations in the aftermath of the COVID-19 pandemic, these findings contribute to the evidence base needed to identify optimal, effective, and equitable approaches to self-monitoring of blood pressure

Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials):protocol for two linked randomised controlled trials

INTRODUCTION: Self-monitoring of blood pressure (BP) in pregnancy could improve the detection and management of pregnancy hypertension, while also empowering and engaging women in their own care. Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2).METHODS AND ANALYSES: Both are multicentre, non-masked, parallel group, randomised controlled trials. Participants will be randomised to self-monitoring with telemonitoring or usual care. BUMP 1 will recruit a minimum of 2262 pregnant women at higher risk of pregnancy hypertension and BUMP 2 will recruit a minimum of 512 pregnant women with either gestational or chronic hypertension. The BUMP 1 primary outcome is the time to the first recording of raised BP by a healthcare professional. The BUMP 2 primary outcome is mean systolic BP between baseline and delivery recorded by healthcare professionals. Other outcomes will include maternal and perinatal outcomes, quality of life and adverse events. An economic evaluation of BP self-monitoring in addition to usual care compared with usual care alone will be assessed across both study populations within trial and with modelling to estimate long-term cost-effectiveness. A linked process evaluation will combine quantitative and qualitative data to examine how BP self-monitoring in pregnancy is implemented and accepted in both daily life and routine clinical practice.ETHICS AND DISSEMINATION: The trials have been approved by a Research Ethics Committee (17/WM/0241) and relevant research authorities. They will be published in peer-reviewed journals and presented at national and international conferences. If shown to be effective, BP self-monitoring would be applicable to a large population of pregnant women.TRIAL REGISTRATION NUMBER: NCT03334149.</p

Blood pressure self-monitoring in pregnancy (BuMP) feasibility study; a qualitative analysis of women’s experiences of self-monitoring

Background: Hypertensive disorders in pregnancy are a leading cause of maternal and fetal morbidity worldwide. Raised blood pressure (BP) affects 10% of pregnancies worldwide, of which almost half develop pre-eclampsia. Theproportion of pregnant women who have risk factors for pre-eclampsia (such as pre-existing hypertension, obesity and advanced maternal age) is increasing. Pre-eclampsia can manifest itself before women experience symptoms and can develop between antenatal visits. Incentives to improve early detection of gestational hypertensive disorders are therefore strong and self-monitoring of blood pressure (SMBP) in pregnancy might be one means to achieve this, whilst improving women’s involvement in antenatal care. The Blood Pressure Self-Monitoring in Pregnancy (BuMP) study aimed to evaluate the feasibility and acceptability of SMBP in pregnancy.Methods: To understand women’s experiences of SMBP during pregnancy, we undertook a qualitative study embedded within the BuMP observational feasibility study. Women who were at higher risk of developing hypertension and/or preeclampsia were invited to take part in a study using SMBP and also invited to take part in an interview. Semi-structured interviews were conducted at the women’s homes in Oxfordshire and Birmingham with women who were selfmonitoring their BP as part of the BuMP feasibility study in 2014. Interviews were conducted by a qualitative researcher and transcribed verbatim. A framework approach was used for analysis.Results: Fifteen women agreed to be interviewed. Respondents reported general willingness to engage with monitoring their own BP, feeling that it could reduce anxiety around their health during pregnancy, particularly if they had previousexperience of raised BP or pre-eclampsia. They felt able to incorporate self-monitoring into their weekly routines, although this was harder post-partum. Self-monitoring of BP made them more aware of the risks of hypertension and pre-eclampsia in pregnancy. Feelings of reassurance and empowerment were commonly reported by the women in our sample

Blood Pressure Self-Monitoring in Pregnancy: Examining Feasibility in a Prospective Cohort Study

BACKGROUND: Raised blood pressure (BP) affects approximately 10% of pregnancies worldwide, and a high proportion of affected women develop pre-eclampsia. This study aimed to evaluate the feasibility of self-monitoring of BP in pregnancy in women at higher risk of pre-eclampsia. METHODS: This prospective cohort study of self-monitoring BP in pregnancy was carried out in two hospital trusts in Birmingham and Oxford and thirteen primary care practices in Oxfordshire. Eligible women were those defined by the UK National Institute for Health and Care Excellence (NICE) guidelines as at higher risk of pre-eclampsia. A total of 201 participants were recruited between 12 and 16 weeks of pregnancy and were asked to take two BP readings twice daily three times a week through their pregnancy. Primary outcomes were recruitment, retention and persistence of self-monitoring. Study recruitment and retention were analysed with descriptive statistics. Survival analysis was used to evaluate the persistence of self-monitoring and the performance of self-monitoring in the early detection of gestational hypertension, compared to clinic BP monitoring. Secondary outcomes were the mean clinic and self-monitored BP readings and the performance of self-monitoring in the detection of gestational hypertension and pre-eclampsia compared to clinic BP. RESULTS: Of 201 women recruited, 161 (80%) remained in the study at 36 weeks or to the end of their pregnancy, 162 (81%) provided any home readings suitable for analysis, 148 (74%) continued to self-monitor at 20 weeks and 107 (66%) at 36 weeks. Self-monitored readings were similar in value to contemporaneous matched clinic readings for both systolic and diastolic BP. Of the 23 who developed gestational hypertension or pre-eclampsia and self-monitored, 9 (39%) had a raised home BP prior to a raised clinic BP. CONCLUSIONS: Self-monitoring of BP in pregnancy is feasible and has potential to be useful in the early detection of gestational hypertensive disorders but maintaining self-monitoring throughout pregnancy requires support and probably enhanced training

Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial

Background Previous evidence supports androgen deprivation therapy (ADT) with primary radiotherapy as initial treatment for intermediate-risk and high-risk localised prostate cancer. However, the use and optimal duration of ADT with postoperative radiotherapy after radical prostatectomy remains uncertain. Methods RADICALS-HD was a randomised controlled trial of ADT duration within the RADICALS protocol. Here, we report on the comparison of short-course versus long-course ADT. Key eligibility criteria were indication for radiotherapy after previous radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to add 6 months of ADT (short-course ADT) or 24 months of ADT (long-course ADT) to radiotherapy, using subcutaneous gonadotrophin-releasing hormone analogue (monthly in the short-course ADT group and 3-monthly in the long-course ADT group), daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as metastasis arising from prostate cancer or death from any cause. The comparison had more than 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 75% to 81% (hazard ratio [HR] 0·72). Standard time-to-event analyses were used. Analyses followed intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov , NCT00541047 . Findings Between Jan 30, 2008, and July 7, 2015, 1523 patients (median age 65 years, IQR 60–69) were randomly assigned to receive short-course ADT (n=761) or long-course ADT (n=762) in addition to postoperative radiotherapy at 138 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 8·9 years (7·0–10·0), 313 metastasis-free survival events were reported overall (174 in the short-course ADT group and 139 in the long-course ADT group; HR 0·773 [95% CI 0·612–0·975]; p=0·029). 10-year metastasis-free survival was 71·9% (95% CI 67·6–75·7) in the short-course ADT group and 78·1% (74·2–81·5) in the long-course ADT group. Toxicity of grade 3 or higher was reported for 105 (14%) of 753 participants in the short-course ADT group and 142 (19%) of 757 participants in the long-course ADT group (p=0·025), with no treatment-related deaths. Interpretation Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy. For individuals who can accept the additional duration of adverse effects, long-course ADT should be offered with postoperative radiotherapy. Funding Cancer Research UK, UK Research and Innovation (formerly Medical Research Council), and Canadian Cancer Society

Effect of self-monitoring of blood pressure on diagnosis of hypertension during higher-risk 2 pregnancy: the BUMP 1 randomized trial

Abstract Importance: Inadequate management of elevated BP is a significant contributing factor to maternal deaths. Self-monitoring of blood pressure (BP) in the general population has been shown to improve the diagnosis and management of hypertension, however little is known about its use in pregnancy. Objective: To determine whether self-monitoring of BP in higher risk pregnancies leads to earlier detection of pregnancy hypertension. Design, setting and participants: Unmasked, randomised clinical trial that recruited between November 2018 and October 2019. 2441 pregnant individuals at higher risk of pre-eclampsia were recruited at 20 weeks’ gestation from 15 hospital maternity units in England with final follow-up in April 2020. Interventions: Participating individuals were randomised to either BP self-monitoring with telemonitoring (n=1223) plus usual care or usual antenatal care alone (n=1218) without access to telemonitored BP. Main Outcomes: The primary outcome was time to first recorded hypertension measured by a healthcare professional. Results: Among 2441 participants who were randomized (mean age, 33; median gestation 20 weeks), 2346 (96%) completed the trial. The time from randomisation to clinic recording of hypertension was not significantly different between individuals in the self-monitoring group (mean 104 days) vs the usual care group (mean 106 days) (mean difference -1.6 days (95% confidence intervals -8.1, 4.9, p = 0.6). Eighteen serious adverse events were reported during the trial with none judged as related to the intervention: 12 (1%) in the self-monitoring group and 6 (0.5%) in those receiving usual care. Conclusions and relevance: Among pregnant individuals at higher risk of pre-eclampsia, blood pressure self-monitoring with telemonitoring compared with usual care did not lead to significantly earlier clinic-based detection of hypertensionNIHR Programme Grants for Applied Researc