Search

Additional file 3. Questionnaire responses from healthcare professionals regarding the care and management for AF.

Additional file 2. Demographic characteristics of included participants.

Supplementary Material 1

Additional file 5. Supporting quotes from healthcare professional’s response to the open-ended questions.

Additional file 1. Quantitative questionnaire for healthcare professionals.

Additional file 4. Questionnaire responses from healthcare professionals regarding the treatment and monitoring for AFa.

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 hypertension

Additional file 6. Data Extraction Form. A copy of the data extraction form used to extract data from each study included in the review.

Supplemental Material for Risk of Bias in Cluster Randomised Controlled Trials of Individual-Level Interventions: Protocol for a Semi-Structured Interview Study by Christina Easter, Caroline Kristunas, Karla Hemming and Sheila Greenfield in Qualitative Study Protocol

Additional file 1.

Additional file 2.

Additional file 2: Table S2.1. Unadjusted and adjusted odds ratio of malarial infection with solid biomass fuels and kerosene cooking compared to cleaner cooking—Analysis 1. Table S2.2. Unadjusted and adjusted odds ratio of malarial infection with wood cooking compared to charcoal cooking—Analysis 2. Table S2.3. Unadjusted and adjusted odds ratio of malarial infection with cooking location (outdoor, in a separate building) compared to indoors—Analysis 3.

Additional file 2. Search Strategy. A detailed description of the search strategies for each database searched in the review.

Additional file 4. Study Results Table. Summary table detailing the results of each included cross-sectional study.

Additional file 3: Table S3.1. Unadjusted odds ratio of malarial infection for each cooking practices for the combined dataset, exploratory and sub-analysis.

Additional file 1. Eligibility Criteria. Eligibility criteria for the research question, using the SPIDER search tool.

Additional file 5. AXIS Summary Table [41]. Summary table of results of the appraisal of cross-sectional studies (AXIS) for each study.

Additional file 1: Table S1.1. Predictors included with the PCA analysis for the modified wealth index by country.

Additional file 3. Study Characteristics Table. Summary table detailing the characteristics of each included cross-sectional study.

Additional file 1. Topic guide for patient focus groups about AF and anticoagulation.

Additional file 7. AXIS Form. A copy of the AXIS form used for the assessment of bias and quality of each study included in the review.

Pregnancy is not a disease or illness, but requires clinical surveillance as life-threatening complications can develop. Preeclampsia, one such potentially serious complication, puts both mother and baby at risk. Self-monitoring blood pressure in the general population is well established, and its potential in pregnancy is currently being explored. In the context of self-monitoring, the information and guidance given to women regarding hypertension, and the literature they themselves seek out during pregnancy, are vital to perceptions of disease risk and subsequent responses to, and management of, any symptoms. Drawing on online, offline, official, and unofficial sources of information, discourses are examined to provide analysis of how self-responsibilization is reflected in contemporary information, advice, and guidance drawn from multiple sources. A paradox emerges between the paternalistic and lay discourses that seek to challenge and regain control. Findings are discussed in the context of Foucault's governmentality and medical power.

Additional file 3. List of themes for participants and practice nurses.

Additional file 1.

Additional file 2. Participants demographics.

Supplemental material, sj-docx-1-qhr-10.1177_10497323211003067 for “You Probably Won’t Notice Any Symptoms”: Blood Pressure in Pregnancy—Discourses of Contested Expertise in an Era of Self-Care and Responsibilization by Lisa Hinton, Alison Chisholm, Beth Jakubowski, Sheila Greenfield, Katherine L Tucker, Richard J McManus and Louise Locock in Qualitative Health Research

Additional file 1. Interview schedules for trial participants and practice nurses.

Supplemental material, sj-docx-1-qhr-10.1177_10497323211003067 for “You Probably Won’t Notice Any Symptoms”: Blood Pressure in Pregnancy—Discourses of Contested Expertise in an Era of Self-Care and Responsibilization by Lisa Hinton, Alison Chisholm, Beth Jakubowski, Sheila Greenfield, Katherine L Tucker, Richard J McManus and Louise Locock in Qualitative Health Research

Importance Inadequate management of elevated blood pressure is a significant contributing factor to maternal deaths. The role of blood pressure self-monitoring in pregnancy in improving clinical outcomes for the pregnant individual and infant is unclear. Objective To evaluate the effect of blood pressure self-monitoring, compared with usual care alone, on blood pressure control and other related maternal and infant outcomes, in individuals with pregnancy hypertension. Design, Setting, and Participants Unblinded, randomized clinical trial that recruited between November 2018 and September 2019 in 15 hospital maternity units in England. Individuals with chronic hypertension (enrolled up to 37 weeks’ gestation) or with gestational hypertension (enrolled between 20 and 37 weeks’ gestation). Final follow-up was in May 2020. Interventions Participants were randomized to either blood pressure self-monitoring using a validated monitor and a secure telemonitoring system in addition to usual care (n = 430) or to usual care alone (n = 420). Usual care comprised blood pressure measured by health care professionals at regular antenatal clinics. Main Outcomes and Measures The primary maternal outcome was the difference in mean systolic blood pressure recorded by health care professionals between randomization and birth. Results Among 454 participants with chronic hypertension (mean age, 36 years; mean gestation at entry, 20 weeks) and 396 with gestational hypertension (mean age, 34 years; mean gestation at entry, 33 weeks) who were randomized, primary outcome data were available from 444 (97.8%) and 377 (95.2%), respectively. In the chronic hypertension cohort, there was no statistically significant difference in mean systolic blood pressure for the self-monitoring groups vs the usual care group (133.8 mm Hg vs 133.6 mm Hg, respectively; adjusted mean difference, 0.03 mm Hg [95% CI, −1.73 to 1.79]). In the gestational hypertension cohort, there was also no significant difference in mean systolic blood pressure (137.6 mm Hg compared with 137.2 mm Hg; adjusted mean difference, −0.03 mm Hg [95% CI, −2.29 to 2.24]). There were 8 serious adverse events in the self-monitoring group (4 in each cohort) and 3 in the usual care group (2 in the chronic hypertension cohort and 1 in the gestational hypertension cohort). Conclusions and Relevance Among pregnant individuals with chronic or gestational hypertension, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly improved clinic-based blood pressure control. Trial Registration ClinicalTrials.gov Identifier: NCT03334149

Additional file 1.

Additional file 1.

Additional file 1. Interview guide. A copy of the interview guide can be provided upon request.

Additional file 2.

Clinical guidelines in the United States and United Kingdom recommend that individuals with suspected hypertension should have ambulatory blood pressure (BP) monitoring to confirm the diagnosis. This approach reduces misdiagnosis because of white coat hypertension but will not identify people with masked hypertension who may benefit from treatment. The Predicting Out-of-Office Blood Pressure (PROOF-BP) algorithm predicts masked and white coat hypertension based on patient characteristics and clinic BP, improving the accuracy of diagnosis while limiting subsequent ambulatory BP monitoring. This study assessed the cost-effectiveness of using this tool in diagnosing hypertension in primary care. A Markov cost-utility cohort model was developed to compare diagnostic strategies: the PROOF-BP approach, including those with clinic BP ≥130/80 mm Hg who receive ambulatory BP monitoring as guided by the algorithm, compared with current standard diagnostic strategies including those with clinic BP ≥140/90 mm Hg combined with further monitoring (ambulatory BP monitoring as reference, clinic, and home monitoring also assessed). The model adopted a lifetime horizon with a 3-month time cycle, taking a UK Health Service/Personal Social Services perspective. The PROOF-BP algorithm was cost-effective in screening all patients with clinic BP ≥130/80 mm Hg compared with current strategies that only screen those with clinic BP ≥140/90 mm Hg, provided healthcare providers were willing to pay up to £20 000 ($26 000)/quality-adjusted life year gained. Deterministic and probabilistic sensitivity analyses supported the base-case findings. The PROOF-BP algorithm seems to be cost-effective compared with the conventional BP diagnostic options in primary care. Its use in clinical practice is likely to lead to reduced cardiovascular disease, death, and disability.

Topic guide. (DOCX 14Â kb)

BACKGROUND: Self-monitoring of hypertension is associated with lower systolic blood pressure (SBP). However, evidence for the use of self-monitoring to titrate antihypertensive medication by physicians is equivocal. Furthermore, there is some evidence for the efficacy of telemonitoring in the management of hypertension but it is not clear what this adds over and above self-monitoring. This trial aims to evaluate whether GP led antihypertensive titration using self-monitoring results in lower SBP compared to usual care and whether telemonitoring adds anything to self-monitoring alone. METHODS/DESIGN: This will be a pragmatic primary care based, unblinded, randomised controlled trial of self-monitoring of BP with or without telemonitoring compared to usual care. Eligible patients will have poorly controlled hypertension (>140/90 mmHg) and will be recruited from primary care. Participants will be individually randomised to either usual care, self-monitoring alone, or self-monitoring with telemonitoring. The primary outcome of the trial will be difference in clinic SBP between intervention and control groups at 12 months adjusted for baseline SBP, gender, BP target and practice. At least 1110 patients will be sufficient to detect a difference in SBP between self-monitoring with or without telemonitoring and usual care of 5 mmHg with 90% power with an adjusted alpha of 0.017 (2-sided) to adjust for all three pairwise comparisons. Other outcomes will include adherence of anti-hypertensive medication, lifestyle behaviours, health-related quality of life, and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative sub study will gain insights into the views, experiences and decision making processes of patients and health care professionals focusing on the acceptability of self-monitoring and telemonitoring in the routine management of hypertension. DISCUSSION: The results of the trial will be directly applicable to primary care in the UK. If successful, self-monitoring of BP in people with hypertension would be applicable to hundreds of thousands of individuals in the UK. TRIAL REGISTRATION: ISRCTN 83571366 . Registered 17 July 2014.

Background Hypertension is a major risk factor for cardiovascular disease and prevalence varies by ethnic group. The diagnosis and management of blood pressure are informed by guidelines largely based on data from white populations. This study addressed whether accuracy of blood pressure measurement in terms of diagnosis of hypertension varies by ethnicity by comparing two measurement modalities (clinic blood pressure and home monitoring) with a reference standard of ambulatory BP monitoring in three ethnic groups. Methods Cross-sectional population study (June 2010 - December 2012) with patients (40–75 years) of white British, South Asian and African Caribbean background with and without a previous diagnosis of hypertension recruited from 28 primary care practices. The study compared the test performance of clinic BP (using various protocols) and home-monitoring (1 week) with a reference standard of mean daytime ambulatory measurements using a threshold of 140/90 mmHg for clinic and 135/85 mmHg for out of office measurement. Results A total of 551 participants had complete data of whom 246 were white British, 147 South Asian and 158 African Caribbean. No consistent difference in accuracy of methods of blood pressure measurement was observed between ethnic groups with or without a prior diagnosis of hypertension: for people without hypertension, clinic measurement using three different methodologies had high specificity (75–97%) but variable sensitivity (33–65%) whereas home monitoring had sensitivity of 68–88% and specificity of 64–80%. For people with hypertension, detection of a raised blood pressure using clinic measurements had sensitivities of 34–69% with specificity of 73–92% and home monitoring had sensitivity (81–88%) and specificity (55–65%). Conclusions For people without hypertension, ABPM remains the choice for diagnosing hypertension compared to the other modes of BP measurement regardless of ethnicity. Differences in accuracy of home monitoring and clinic monitoring (higher sensitivity of the former; higher specificity of the latter) were also not affected by ethnicity. Electronic supplementary material The online version of this article (doi:10.1186/s12872-017-0491-8) contains supplementary material, which is available to authorized users.

Study Procedures. (DOCX 20 kb)

Diagnostic output of raw data at different BP thresholds. (DOCX 19Â kb)

Exclusions of home data. (DOCX 21 kb)

PRISMA-P 2015 checklist. (DOCX 36Â kb)

Exclusions of home data. (DOCX 21 kb)

Participant Interpretation Chart. (DOCX 13 kb)

Participant Interpretation Chart. (DOCX 13 kb)

Medline search strategy. (DOCX 15Â kb)

Interview Topic Guide- topic guide used for individual interviews. (PDF 50 kb)

Focus Group Protocol- protocol used for focus group discussion. (PDF 49 kb)