Adaptive servo-ventilation for sleep-disordered breathing in patients with heart failure with reduced ejection fraction (ADVENT-HF): a multicentre, multinational, parallel-group, open-label, phase 3 randomised controlled trial

BACKGROUND: In patients with heart failure and reduced ejection fraction, sleep-disordered breathing, comprising obstructive sleep apnoea (OSA) and central sleep apnoea (CSA), is associated with increased morbidity, mortality, and sleep disruption. We hypothesised that treating sleep-disordered breathing with a peak-flow triggered adaptive servo-ventilation (ASV) device would improve cardiovascular outcomes in patients with heart failure and reduced ejection fraction. METHODS: We conducted a multicentre, multinational, parallel-group, open-label, phase 3 randomised controlled trial of peak-flow triggered ASV in patients aged 18 years or older with heart failure and reduced ejection fraction (left ventricular ejection fraction ≤45%) who were stabilised on optimal medical therapy with co-existing sleep-disordered breathing (apnoea-hypopnoea index [AHI] ≥15 events/h of sleep), with concealed allocation and blinded outcome assessments. The trial was carried out at 49 hospitals in nine countries. Sleep-disordered breathing was stratified into predominantly OSA with an Epworth Sleepiness Scale score of 10 or lower or predominantly CSA. Participants were randomly assigned to standard optimal treatment alone or standard optimal treatment with the addition of ASV (1:1), stratified by study site and sleep apnoea type (ie, CSA or OSA), with permuted blocks of sizes 4 and 6 in random order. Clinical evaluations were performed and Minnesota Living with Heart Failure Questionnaire, Epworth Sleepiness Scale, and New York Heart Association class were assessed at months 1, 3, and 6 following randomisation and every 6 months thereafter to a maximum of 5 years. The primary endpoint was the cumulative incidence of the composite of all-cause mortality, first admission to hospital for a cardiovascular reason, new onset atrial fibrillation or flutter, and delivery of an appropriate cardioverter-defibrillator shock. All-cause mortality was a secondary endpoint. Analysis for the primary outcome was done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT01128816) and the International Standard Randomised Controlled Trial Number Register (ISRCTN67500535), and the trial is complete. FINDINGS: The first and last enrolments were Sept 22, 2010, and March 20, 2021. Enrolments terminated prematurely due to COVID-19-related restrictions. 1127 patients were screened, of whom 731 (65%) patients were randomly assigned to receive standard care (n=375; mean AHI 42·8 events per h of sleep [SD 20·9]) or standard care plus ASV (n=356; 43·3 events per h of sleep [20·5]). Follow-up of all patients ended at the latest on June 15, 2021, when the trial was terminated prematurely due to a recall of the ASV device due to potential disintegration of the motor sound-abatement material. Over the course of the trial, 41 (6%) of participants withdrew consent and 34 (5%) were lost to follow-up. In the ASV group, the mean AHI decreased to 2·8-3·7 events per h over the course of the trial, with associated improvements in sleep quality assessed 1 month following randomisation. Over a mean follow-up period of 3·6 years (SD 1·6), ASV had no effect on the primary composite outcome (180 events in the control group vs 166 in the ASV group; hazard ratio [HR] 0·95, 95% CI 0·77-1·18; p=0·67) or the secondary endpoint of all-cause mortality (88 deaths in the control group vs. 76 in the ASV group; 0·89, 0·66-1·21; p=0·47). For patients with OSA, the HR for all-cause mortality was 1·00 (0·68-1·46; p=0·98) and for CSA was 0·74 (0·44-1·23; p=0·25). No safety issue related to ASV use was identified. INTERPRETATION: In patients with heart failure and reduced ejection fraction and sleep-disordered breathing, ASV had no effect on the primary composite outcome or mortality but eliminated sleep-disordered breathing safely.

Adaptive servo-ventilation for sleep-disordered breathing in patients with heart failure with reduced ejection fraction (ADVENT-HF): a multicentre, multinational, parallel-group, open-label, phase 3 randomised controlled trial.

BACKGROUND: In patients with heart failure and reduced ejection fraction, sleep-disordered breathing, comprising obstructive sleep apnoea (OSA) and central sleep apnoea (CSA), is associated with increased morbidity, mortality, and sleep disruption. We hypothesised that treating sleep-disordered breathing with a peak-flow triggered adaptive servo-ventilation (ASV) device would improve cardiovascular outcomes in patients with heart failure and reduced ejection fraction. METHODS: We conducted a multicentre, multinational, parallel-group, open-label, phase 3 randomised controlled trial of peak-flow triggered ASV in patients aged 18 years or older with heart failure and reduced ejection fraction (left ventricular ejection fraction ≤45%) who were stabilised on optimal medical therapy with co-existing sleep-disordered breathing (apnoea-hypopnoea index [AHI] ≥15 events/h of sleep), with concealed allocation and blinded outcome assessments. The trial was carried out at 49 hospitals in nine countries. Sleep-disordered breathing was stratified into predominantly OSA with an Epworth Sleepiness Scale score of 10 or lower or predominantly CSA. Participants were randomly assigned to standard optimal treatment alone or standard optimal treatment with the addition of ASV (1:1), stratified by study site and sleep apnoea type (ie, CSA or OSA), with permuted blocks of sizes 4 and 6 in random order. Clinical evaluations were performed and Minnesota Living with Heart Failure Questionnaire, Epworth Sleepiness Scale, and New York Heart Association class were assessed at months 1, 3, and 6 following randomisation and every 6 months thereafter to a maximum of 5 years. The primary endpoint was the cumulative incidence of the composite of all-cause mortality, first admission to hospital for a cardiovascular reason, new onset atrial fibrillation or flutter, and delivery of an appropriate cardioverter-defibrillator shock. All-cause mortality was a secondary endpoint. Analysis for the primary outcome was done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT01128816) and the International Standard Randomised Controlled Trial Number Register (ISRCTN67500535), and the trial is complete. FINDINGS: The first and last enrolments were Sept 22, 2010, and March 20, 2021. Enrolments terminated prematurely due to COVID-19-related restrictions. 1127 patients were screened, of whom 731 (65%) patients were randomly assigned to receive standard care (n=375; mean AHI 42·8 events per h of sleep [SD 20·9]) or standard care plus ASV (n=356; 43·3 events per h of sleep [20·5]). Follow-up of all patients ended at the latest on June 15, 2021, when the trial was terminated prematurely due to a recall of the ASV device due to potential disintegration of the motor sound-abatement material. Over the course of the trial, 41 (6%) of participants withdrew consent and 34 (5%) were lost to follow-up. In the ASV group, the mean AHI decreased to 2·8-3·7 events per h over the course of the trial, with associated improvements in sleep quality assessed 1 month following randomisation. Over a mean follow-up period of 3·6 years (SD 1·6), ASV had no effect on the primary composite outcome (180 events in the control group vs 166 in the ASV group; hazard ratio [HR] 0·95, 95% CI 0·77-1·18; p=0·67) or the secondary endpoint of all-cause mortality (88 deaths in the control group vs. 76 in the ASV group; 0·89, 0·66-1·21; p=0·47). For patients with OSA, the HR for all-cause mortality was 1·00 (0·68-1·46; p=0·98) and for CSA was 0·74 (0·44-1·23; p=0·25). No safety issue related to ASV use was identified. INTERPRETATION: In patients with heart failure and reduced ejection fraction and sleep-disordered breathing, ASV had no effect on the primary composite outcome or mortality but eliminated sleep-disordered breathing safely. FUNDING: Canadian Institutes of Health Research and Philips RS North America.

Characterizing Hypertension Specialist Care in Canada: A National Survey.

Background: The hypertension specialist often receives referrals of patients with young-onset, severe, difficult-to-control hypertension, patients with hypertensive emergencies, and patients with secondary causes of hypertension. Specialist hypertension care compliments primary care for these complex patients and contributes to an overall hypertension control strategy. The objective of this study was to characterize hypertension centres and the practice patterns of Canadian hypertension specialists. Methods: Adult hypertension specialists across Canada were surveyed to describe hypertension centres and specialist practice in Canada, including the following: the patient population managed by hypertension specialists; details on how care is provided; practice pattern variations; and differences in access to specialized hypertension resources across the country. Results: The survey response rate was 73.5% from 25 hypertension centres. Most respondents were nephrologists and general internal medicine specialists. Hypertension centres saw between 50 and 2500 patients yearly. A mean of 17% (± 15%) of patients were referred from the emergency department and a mean of 52% (± 24%) were referred from primary care. Most centres had access to specialized testing (adrenal vein sampling, level 1 sleep studies, autonomic testing) and advanced therapies for resistant hypertension (renal denervation). Considerable heterogeneity was present in the target blood pressure in young people with low cardiovascular risk and in the diagnostic algorithms for investigating secondary causes of hypertension. Conclusions: These results summarize the current state of hypertension specialist care and highlight opportunities for further collaboration among hypertension specialists, including standardization of the approach to specialist care for patients with hypertension.

Contexte: Le spécialiste de l'hypertension reçoit souvent des patients orientés pour une hypertension sévère, d'apparition précoce et difficile à maîtriser, pour une urgence hypertensive ou pour des causes secondaires de l'hypertension. Les soins spécialisés de l'hypertension complètent les soins primaires pour ces cas complexes et font partie d'une stratégie globale de maîtrise de l'hypertension. Cette étude avait pour objectif de caractériser les centres de traitement de l'hypertension et les habitudes de pratique des spécialistes canadiens qui traitent l'hypertension. Méthodologie: Un sondage a été mené auprès de spécialistes de l'hypertension adulte de l'ensemble du Canada afin de décrire les centres de traitement de l'hypertension et la pratique des spécialistes au Canada, notamment les éléments suivants : la population de patients prise en charge par des spécialistes de l'hypertension, les renseignements sur la façon dont les soins sont prodigués, les variations dans les habitudes de pratique ainsi que les différences relatives à l'accès aux ressources spécialisées en hypertension à l'échelle du pays. Résultats: Le taux de réponse au sondage a été de 73,5 % dans 25 centres de l'hypertension. La plupart des répondants étaient des néphrologues et des spécialistes en médecine interne générale. Les centres de l'hypertension recevaient entre 50 et 2500 patients par année. En moyenne, 17 % (± 15 %) des patients provenaient du service des urgences et 52 % (± 24 %) provenaient d'une unité de soins primaires. La plupart des centres avaient accès à des tests spécialisés (prélèvements veineux surrénaliens, études du sommeil de niveau 1, tests autonomes) et à des traitements avancés pour l'hypertension résistante (dénervation rénale). Une hétérogénéité considérable a été constatée en ce qui concerne la pression artérielle cible chez les jeunes présentant un faible risque cardiovasculaire et les algorithmes diagnostiques pour étudier les causes secondaires de l'hypertension. Conclusions: Ces résultats résument la situation actuelle des soins spécialisés de l'hypertension et font ressortir des occasions d'accroître la collaboration entre les spécialistes de l'hypertension, notamment en ce qui concerne une normalisation de l'approche des soins spécialisés pour les patients hypertendus.

Design and Development of a Digital Counseling Program for Chronic Kidney Disease.

Background: Self-management has shown to improve the quality of life in patients with chronic kidney disease (CKD). Readily accessible self-management tools are essential in promoting adherence to self-care behaviors. In recognizing that digital health facilitates efficient access to self-management programs, we developed a digital counseling program, ODYSSEE Kidney Health, to promote self-care behaviors while supporting health-related quality of life. Objective: To present the design and development of ODYSSEE Kidney Health for digital counseling for patients with CKD. Design: The study involved an iterative design process based on user-centered design principles to develop the digital counseling program, ODYSSEE Kidney Health. Setting: A sample of 10 to 15 participants were purposively sampled from nephrology clinics at the University Health Network, Toronto, Canada. Methods: Participants underwent 2 phases in the development process. In each phase, participants were presented with a component of the program, asked to perform goal-oriented tasks, and participate in the "think-aloud" process. Semi-structured interviews followed the first phase to identify feedback about the overall program. Thematic analysis of the interviews identified themes from the usability testing. Descriptive statistics were used to summarize patient demographic data. Results: We enrolled 11 participants (n = 7 males, n = 4 females, ages 30-82). The main themes generated anchored on (1) impact on nephrology care, (2) technical features, and (3) CKD content. Overall, participants reported positive satisfaction toward the navigation, layout, and content of the program. They cited the value of the program in their daily CKD care. Limitations: Study limitations included using a single center to recruit participants, most of the participants having prior technology use, and using one module as a representative of the entire digital platform. Conclusion: The acceptability of a digital counseling program for patients with CKD relies on taking the patients' perspective using a user-centered design process. It is vital in ensuring adoption and adherence to self-management interventions aimed at sustaining behavioral change.

Contexte: L'autogestion s'est avérée efficace pour améliorer la qualité de vie des patients atteints d'insuffisance rénale chronique (IRC). Des outils d'autogestion facilement accessibles sont essentiels pour favoriser l'adhésion aux comportements d'autogestion. Conscients que la santé numérique facilite l'accès efficace aux programmes d'autogestion, nous avons mis au point un programme de consultation numérique, ODYSSEE Kidney Health, afin de promouvoir les comportements d'autogestion tout en soutenant la qualité de vie liée à la santé. Objectif: Présenter la conception et le développement du programme de consultation numérique ODYSSEE Kidney Health, destiné aux patients atteints d'IRC. Conception: L'étude a impliqué un processus de conception itératif fondé sur des principes de conception axés sur l'utilisateur pour développer le programme de consultation numérique, ODYSSEE Kidney Health. Participants: Un échantillon de 10 à 15 participants choisis à dessein dans des cliniques de néphrologie du University Health Network de Toronto (Canada). Méthodologie: Les participants ont pris part à deux phases du processus de développement. À chaque phase, une composante du programme a été présentée aux participants et ceux-ci ont été invités à effectuer des tâches axées sur les objectifs et à participer à un processus de « réflexion à voix haute ¼. Des entretiens semi-structurés ont suivi la première phase pour fournir de la rétroaction sur le programme dans son ensemble. L'analyse thématique des entretiens a permis de dégager les thèmes des tests d'utilisabilité. Des statistiques descriptives ont servi à présenter les données démographiques des patients. Résultats: Nous avons inclus 11 participants (7 hommes, 4 femmes; de 30 à 82 ans). Les principaux thèmes générés sont ancrés sur: 1) l'impact sur les soins de néphrologie, 2) les caractéristiques techniques et 3) le contenu sur l'IRC. Dans l'ensemble, les participants étaient satisfaits de leur expérience de navigation, de la disposition des contenus et du contenu du programme. Ils ont mentionné la valeur du programme dans leurs soins quotidiens d'IRC. Limites: Un seul centre a été utilisé pour recruter des participants, la majorité des participants avait déjà utilisé la technologie et un seul module a été utilisé pour représenter l'ensemble de la plateforme numérique. Conclusion: L'acceptabilité d'un programme de consultation numérique destiné aux patients atteints d'IRC repose sur la prise en compte du point de vue des patients par le biais d'un processus de conception axé sur l'utilisateur. Ceci est essentiel pour garantir l'adoption et l'adhésion aux interventions d'autogestion visant à pérenniser les changements de comportement.

The worldwide impact of telemedicine during COVID-19: current evidence and recommendations for the future.

During the COVID-19 pandemic, telemedicine has emerged worldwide as an indispensable resource to improve the surveillance of patients, curb the spread of disease, facilitate timely identification and management of ill people, but, most importantly, guarantee the continuity of care of frail patients with multiple chronic diseases. Although during COVID-19 telemedicine has thrived, and its adoption has moved forward in many countries, important gaps still remain. Major issues to be addressed to enable large scale implementation of telemedicine include: (1) establishing adequate policies to legislate telemedicine, license healthcare operators, protect patients' privacy, and implement reimbursement plans; (2) creating and disseminating practical guidelines for the routine clinical use of telemedicine in different contexts; (3) increasing in the level of integration of telemedicine with traditional healthcare services; (4) improving healthcare professionals' and patients' awareness of and willingness to use telemedicine; and (5) overcoming inequalities among countries and population subgroups due to technological, infrastructural, and economic barriers. If all these requirements are met in the near future, remote management of patients will become an indispensable resource for the healthcare systems worldwide and will ultimately improve the management of patients and the quality of care.

Challenges of Telemonitoring Programs for Complex Chronic Conditions: Randomized Controlled Trial With an Embedded Qualitative Study.

BACKGROUND: Despite the growing prevalence of people with complex conditions and evidence of the positive impact of telemonitoring for single conditions, little research exists on telemonitoring for this population. OBJECTIVE: This randomized controlled trial and embedded qualitative study aims to evaluate the impact on and experiences of patients and health care providers (HCPs) using a telemonitoring system with decision support to manage patients with complex conditions, including those with multiple chronic conditions, compared with the standard of care. METHODS: A pragmatic, unblinded, 6-month randomized controlled trial sought to recruit 146 patients with ≥1 diagnosis of heart failure (HF), uncontrolled hypertension (HT), and insulin-requiring diabetes mellitus (DM) from outpatient specialty settings in Toronto, Ontario, Canada. Participants were randomized into the control and telemonitoring groups, with the latter being instructed to take readings relevant to their conditions. The telemonitoring system contained an algorithm that generated decision support in the form of actionable self-care directives to patients and alerts to HCPs. The primary outcome was health status (36-Item Short Form Health Survey questionnaire). Secondary outcomes included anxiety and depression, self-efficacy in chronic disease management, and self-reported health service use. HF-related quality of life and self-care measures were also collected from patients followed for HF. Within- and between-group change scores were analyzed for statistical significance (P<.05). A convenience sample of HCPs and patients in the intervention group was interviewed about their experiences. RESULTS: A total of 96 patients were recruited and randomized. Recruitment was terminated early because of implementation challenges and the onset of the COVID-19 pandemic. No significant within- and between-group differences were found for the main primary and secondary outcomes. However, a within-group analysis of patients with HF found improvements in self-care maintenance (P=.04) and physical quality of life (P=.046). Opinions expressed by the 5 HCPs and 13 patients who were interviewed differed based on the monitored conditions. Although patients with HF reported benefitting from actionable self-care guidance and meaningful interactions with their HCPs, patient and HCP users of the DM and HT modules did not think telemonitoring improved the clinical management of those conditions to the same degree. These differing experiences were largely attributed to the siloed nature of specialty care and the design of the decision support, whereby fluctuations in the status of HT and DM typically required less urgent interventions compared with patients with HF. CONCLUSIONS: We recommend that future research conceive telemonitoring as a program and that self-management and clinical decision support are necessary but not sufficient components of such programs for patients with complex conditions and lower acuity. We conclude that telemonitoring for patients with complex conditions or within multidisciplinary care settings may be best operationalized through nurse-led models of care. TRIAL REGISTRATION: ClinicalTrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.8367.

Twelve tips for teaching and supervising post-graduate trainees in clinic.

By providing quality teaching and supervision, medical educators can contribute to productive and fulfilling outpatient experiences for postgraduate trainees (sometimes called residents, registrars, or GP trainees). The recent literature addressing practical steps to improve outpatient teaching is limited. Here we present specific trainee-centric behaviors, techniques, and language that educators can employ to enhance their teaching in the outpatient clinic, in the form of twelve tips. The first two tips pertain to navigating the patient-trainee-supervisor dynamic in the exam room, the next four address listening to an oral presentation, and the last six are tips on being an effective teacher and coach.

Virtual Interactive Case-Based Education (VICE): A Conference for Deliberate Practice of Diagnostic Reasoning.

Introduction: Current approaches to teaching diagnostic reasoning minimally address the need for deliberate practice. We developed an educational conference for internal medicine residents to practice diagnostic reasoning and examine how biases affect their differential diagnoses through cognitive autopsies. Methods: We formatted the Virtual Interactive Case-Based Education (VICE) conference as a clinical problem-solving exercise, in which a facilitator presents a case to a single discussant selected from the audience. We delivered VICE on an internet-based conferencing platform with screen-sharing capability over approximately 30 minutes. To maximize learners' psychological safety, we employed an active facilitation model that normalized uncertainty and prioritized the diagnostic process over arriving at the correct diagnosis. Results: Resident attitudes toward VICE were assessed by utilizing a postconference survey and gathering descriptive data for 11 sessions. Ninety-seven percent of respondents (n = 35) felt that VICE was a novel and valuable addition to their curriculum. Qualitative data suggested that positive features of the conference included the opportunity to practice diagnostic reasoning, the single-discussant format, and the supportive learning environment. Discussants reported that holding the conference in person would have negatively impacted their experience. Discussion: Internal medicine residents universally valued the opportunity to engage in deliberate practice of case-based reasoning in a psychologically safe environment during the VICE conference. The virtual nature of the conference contributed significantly to discussants' positive experience. This resource includes all materials necessary to implement VICE, as well as an instructional video on facilitation.

"It's that longitudinal relationship that pays off": A qualitative study of internal medicine residents' perspectives on learning to prescribe buprenorphine.

Background: The opioid use disorder (OUD) epidemic is a national public health crisis. Access to effective treatment with buprenorphine is limited, in part because few physicians are trained to prescribe it. Little is known about how post-graduate trainees learn to prescribe buprenorphine or how to optimally train them to prescribe. We therefore aimed to explore the experiences and attitudes of residents learning to prescribe buprenorphine within two primary care-based opioid treatment models. Methods: We performed semi-structured interviews with second- and third-year internal medicine residents at an urban academic residency program. Participating residents practiced in clinics providing buprenorphine care using either a nurse care manager model or a provider-centric model. Subjects were sampled purposively to ensure that a diversity of perspectives were included. Interviews were conducted until theoretical saturation was reached and were analyzed using principles of thematic analysis. The research team developed a consensus code list. Each transcript was then independently coded by two researchers. The team then summarized each code and generated a set of themes that captured the main ideas emerging from the data. Results: We completed 14 interviews. Participants reported learning to prescribe buprenorphine through didactics, longitudinal outpatient prescribing, mentorship, and inpatient experiences. We characterized their attitudes toward patients with OUD, medication treatment of OUD, their own role in buprenorphine care, and future prescribing. Participants practicing in both clinical models viewed learning to prescribe buprenorphine as a normal part of their training and demonstrated positive attitudes toward buprenorphine prescribing. Conclusions: Longitudinal outpatient experiences with buprenorphine prescribing can prepare residents to prescribe buprenorphine and stimulate interest in prescribing after residency. Both nurse care manager and provider-centric clinical models can provide meaningful experiences for medical residents. Educators should attend to the volume of patients and inductions managed by each trainee, patient-provider continuity, and supporting trainees in the clinical encounter.

Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial.

BACKGROUND AND OBJECTIVES: Patients with CKD are at risk for adverse drug reactions, but effective community-based preventive programs remain elusive. In this study, we compared the effectiveness of two digital applications designed to improve outpatient medication safety. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In a 1-year randomized controlled trial, 182 outpatients with advanced CKD were randomly assigned to receive a smartphone preloaded with either eKidneyCare (n=89) or MyMedRec (n=93). The experimental intervention, eKidneyCare, includes a medication feature that prompted patients to review medications monthly and report changes, additions, or medication problems to clinicians for reconciliation and early intervention. The active comparator was MyMedRec, a commercially available, standalone application for storing medication and other health information that can be shared with patients' providers. The primary outcome was the rate of medication discrepancy, defined as differences between the patient's reported history and the clinic's medication record, at exit. RESULTS: At exit, the eKidneyCare group had fewer total medication discrepancies compared with MyMedRec (median, 0.45; interquartile range, 0.33-0.63 versus 0.67; interquartile range, 0.40-1.00; P=0.001), and the change from baseline was 0.13±0.27 in eKidneyCare and 0.30±0.41 in MyMedRec (P=0.007). eKidneyCare use also reduced the severity of clinically relevant medication discrepancies in all categories, including those with the potential to cause serious harm (estimated rate ratio, 0.40; 95% confidence interval, 0.27 to 0.63). Usage data revealed that 72% of patients randomized to eKidneyCare completed one or more medication reviews per month, whereas only 30% of patients in the MyMedRec group (adjusted for dropouts) kept their medication profile on their phone. CONCLUSIONS: In patients who are high risk and have CKD, eKidneyCare significantly reduced the rate and severity of medication discrepancies, the proximal cause of medication errors, compared with the active comparator. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: www.ClinicalTrials.gov, NCT:02905474.

Pregnancy Outcomes and Blood Pressure Visit-to-Visit Variability and Level in Three Less-Developed Countries.

[Figure: see text].

Evidence and Recommendations on the Use of Telemedicine for the Management of Arterial Hypertension: An International Expert Position Paper.

Telemedicine allows the remote exchange of medical data between patients and healthcare professionals. It is used to increase patients' access to care and provide effective healthcare services at a distance. During the recent coronavirus disease 2019 (COVID-19) pandemic, telemedicine has thrived and emerged worldwide as an indispensable resource to improve the management of isolated patients due to lockdown or shielding, including those with hypertension. The best proposed healthcare model for telemedicine in hypertension management should include remote monitoring and transmission of vital signs (notably blood pressure) and medication adherence plus education on lifestyle and risk factors, with video consultation as an option. The use of mixed automated feedback services with supervision of a multidisciplinary clinical team (physician, nurse, or pharmacist) is the ideal approach. The indications include screening for suspected hypertension, management of older adults, medically underserved people, high-risk hypertensive patients, patients with multiple diseases, and those isolated due to pandemics or national emergencies.

Are blood pressure level and variability related to pregnancy outcome? Analysis of control of hypertension in pregnancy study data.

OBJECTIVE: To examine the relationship between pregnancy outcomes and BP level and variability. DESIGN: Secondary analysis of CHIPS trial data (Control of Hypertension In Pregnancy Study, NCT01192412). SETTING: International. POPULATION OR SAMPLE: Women with chronic or gestational hypertension. METHODS: BP measurement was standardised in outpatient clinics. Adjusted (including for allocated group) mixed effects logistic regression was used to assess relationships between major CHIPS outcomes and both BP level (mean of clinic readings) and visit-to-visit within-participant BP variability (standard deviation and average real variability of absolute successive difference of BP values). BP values 7-28 days prior to outcomes (or birth for perinatal outcomes) were excluded in sensitivity analyses. MAIN OUTCOME MEASURES: Major CHIPS outcomes. RESULTS: Among 961 (97.4%) women, higher BP level was associated with more adverse maternal and perinatal outcomes (usually at p < 0.001) except for serious maternal complications. Among 913 (92.5%) women with at least two post-randomisation outpatient visits, higher BP variability was associated with increased odds of severe hypertension and pre-eclampsia (usually at p < 0.01). Sensitivity analyses suggested reverse causality for these maternal outcomes, but greater diastolic BP variability may have been associated with fewer adverse perinatal outcomes. CONCLUSIONS: Higher BP is an adverse prognostic marker, regardless of target BP. While the association between higher BP variability and severe hypertension and pre-eclampsia may be related to higher BP at diagnosis, our results suggest a possible advantage of BP variability for the fetus, through undefined mechanisms. TWEETABLE ABSTRACT: Higher blood pressure (BP) is associated with more adverse pregnancy outcomes, but higher BP variability may be good for the baby.

Management of non-severe pregnancy hypertension - A summary of the CHIPS Trial (Control of Hypertension in Pregnancy Study) research publications.

The international CHIPS Trial (Control of Hypertension In Pregnancy Study) enrolled 987 women with chronic (75%) or gestational (25%) hypertension. Pre-eclampsia developed in 48%; women remained on their allocated BP control and delivered an average of two weeks later. 'Less tight' control (target diastolic BP 100 mmHg) achieved BP that was 6/5mmHg higher (p < 0.001) than 'tight' control (target diastolic 85 mmHg, BP achieved 133/85 mmHg). 'Less tight' (vs. 'tight') control resulted in similar adverse perinatal outcomes (31.5% vs. 30.7%; p = 0.84) that balanced birthweight < 10th percentile (16.1% vs. 19.8%; p = 0.14) against preterm birth (35.6% vs. 31.5%; p = 0.18). 12-month follow-up revealed no compelling evidence for developmental programming of child growth. However, 'less tight' (vs. 'tight') control resulted in more severe maternal hypertension (40.6% vs. 27.5%; p < 0.001), and more women with platelets < 100 × 109/L (4.3% vs. 1.6%; p = 0.02) or symptomatic elevated liver enzymes (4.3% vs. 1.8%; p = 0.03), with no difference in serious maternal complications (3.7% vs. 2.0%; p = 0.17). Labetalol was the drug of choice. Methyldopa did not result in inferior outcomes. Post-hoc, severe hypertension, independent of pre-eclampsia, was associated with heightened increased risk of adverse outcomes, and in 'less tight' control, of serious maternal complications. At no gestational age at initiation of BP control was 'less tight' superior to 'tight'. Women in both groups were equally satisfied with care. 'Less tight' control tended to be more expensive by CAD$6000 (p =0.07) based on neonatal care costs. Collectively, CHIPS publications have provided evidence that women with non-severe pregnancy hypertension should receive 'tight' BP control achieved by a simple algorithm.

"Rebuilding what has eroded": a descriptive, survey-based study of near-peer instructors' experiences in a critical pedagogy-based sociomedical course.

Purpose: Near-peer assisted learning has been deployed in numerous settings within medical education with promising results. However, there is very little experience utilizing near-peers in sociomedical or cultural competency training. We recently described a novel model for sociomedical learning based on Introduction to Medicine and Society (IMS), a critical pedagogy-based course at the Perelman School of Medicine at the University of Pennsylvania (PSOM). Near-peer facilitation, by senior medical students, is central to this model. The aim of this descriptive study is to examine how facilitating within this curriculum impacts senior medical students' self-reported attitudes toward course content, medical education, as well as self-care and medical practice. Methods: At the conclusion of the course, near-peer facilitator attitudes were assessed in three key domains through an anonymous survey. Attitudes were rated according to a 5-point Likert scale. Data from subgroups were analyzed using standard two-tailed t-tests. Optional narrative data were also collected. Results: Twenty six of 34 (76%) eligible facilitators completed the survey. Strong majorities of facilitators felt that their experience facilitating IMS had a favorable effect on attitudes related to course content (sociomedical issues and communication skills). A majority also endorsed favorable changes in their attitudes toward teaching and medical education. Large proportions of facilitators endorsed positive changes in a number of domains linked to trainee resilience. Conclusions: Our descriptive data suggest that acting as a near-peer facilitator as a senior medical student within a critical pedagogy-based course could help to fill multiple important curricular gaps at the transition from medical school to residency. Moreover, we find that a sociomedical facilitation experience during this important transition may increase enthusiasm for careers in medical education and undo some of the negative impacts of clinical training during medical school.

Hypertension Canada's 2018 Guidelines for the Management of Hypertension in Pregnancy.

We present Hypertension Canada's inaugural evidence-based Canadian recommendations for the management of hypertension in pregnancy. Hypertension in pregnancy is common, affecting approximately 7% of pregnancies in Canada, and requires effective management to reduce maternal, fetal, and newborn complications. Because of this importance, these guidelines were developed in partnership with the Society of Obstetricians and Gynaecologists of Canada with the main common objective of improving the management of women with hypertension in pregnancy. Guidelines for the diagnosis, assessment, prevention, and treatment of hypertension in adults and children are published separately. In this first Hypertension Canada guidelines for hypertension in pregnancy, 7 recommendations for the management of nonsevere and severe hypertension in pregnancy are presented. For nonsevere hypertension in pregnancy (systolic blood pressure 140-159 mm Hg and/or diastolic blood pressure 80-109 mm Hg), we provide guidance for the threshold for initiation of antihypertensive therapy, blood pressure targets, as well as first- and second-line antihypertensive medications. Severe hypertension (systolic blood pressure ≥ 160 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg) requires urgent antihypertensive therapy to reduce maternal, fetal, and newborn adverse outcomes. The specific evidence and rationale underlying each of these guidelines are discussed.