ABSTRACT
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.
Subject(s)
Sleep Apnea Syndromes/complications , Ventricular Function, Left , Stroke Volume , Heart Failure/complicationsABSTRACT
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.
Subject(s)
Heart Failure , Sleep Apnea Syndromes , Sleep Apnea, Central , Sleep Apnea, Obstructive , Humans , Stroke Volume , Sleepiness , Ventricular Function, Left , Canada , Sleep Apnea Syndromes/complications , Sleep Apnea Syndromes/therapy , Heart Failure/complications , Heart Failure/therapy , Sleep Apnea, Central/therapy , Sleep Apnea, Central/complications , Sleep Apnea, Obstructive/therapy , Treatment OutcomeABSTRACT
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.
ABSTRACT
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.
ABSTRACT
In pregnancy in well-resourced settings, limited data suggest that higher blood pressure (BP) visit-to-visit variability may be associated with adverse pregnancy outcomes. Included were pregnant women in 22 intervention clusters of the CLIP (Community-Level Interventions for Preeclampsia) cluster randomized trials, who had received at least 2 prenatal contacts from a community health worker, including standardized BP measurement. Mixed-effects adjusted logistic regression assessed relationships between pregnancy outcomes and both BP level (median [interquartile range]) and visit-to-visit variability (SD and average real variability [ARV], adjusted for BP level), among all women and those who became hypertensive. The primary outcome was the CLIP composite of maternal and perinatal mortality and morbidity. Among 17 770 pregnancies, higher systolic and diastolic BP levels were associated with increased odds of the composite outcome per 5 mm Hg increase in BP (odds ratio [OR], 1.05 [95% CI, 1.031.07] and OR, 1.08 [1.061.11], respectively). Higher BP visit-to-visit variability was associated with increased odds, per a SD increase in BP variability measure, of (1) hypertension (systolic: OR, 2.09 [1.982.21] for SD and 1.52 [1.451.60] for ARV; diastolic: OR, 2.70 [2.542.87] for SD and 1.86 [1.761.96] for ARV); and (2) the composite outcome (systolic: OR, 1.10 [1.061.14] for SD and 1.06 [1.021.10] for ARV; diastolic: OR, 1.07 [1.031.11] for SD and 1.06 [1.021.09] for ARV). In 3 less-developed countries, higher BP level and visit-to-visit variability predicted adverse pregnancy outcomes, providing an opportunity for high-definition medicine.
Subject(s)
Humans , Female , Pregnancy , Middle Aged , Young Adult , Pregnancy Outcome , Hypertension, Pregnancy-Induced/physiopathology , Arterial Pressure/physiology , Maternal Mortality , MozambiqueABSTRACT
[Figure: see text].
Subject(s)
Blood Pressure/physiology , Hypertension, Pregnancy-Induced/physiopathology , Pregnancy Outcome , Adolescent , Adult , Child , Female , Humans , India , Maternal Mortality , Middle Aged , Mozambique , Pakistan , Pregnancy , Young AdultABSTRACT
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.
Subject(s)
Ambulatory Care/methods , Drug-Related Side Effects and Adverse Reactions/prevention & control , Renal Insufficiency, Chronic , Smartphone , Telemedicine , Adult , Aged , Female , Humans , Male , Middle Aged , Risk Assessment , Single-Blind MethodABSTRACT
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.
Subject(s)
Coronavirus Infections/prevention & control , Cross Infection/prevention & control , Hypertension/drug therapy , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Telemedicine/statistics & numerical data , Blood Pressure Determination/methods , COVID-19 , Coronavirus Infections/epidemiology , Disease Management , Evidence-Based Medicine , Female , Humans , Hypertension/diagnosis , Italy , Male , Occupational Health , Pandemics/statistics & numerical data , Patient Safety , Pneumonia, Viral/epidemiology , Severity of Illness IndexABSTRACT
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 7-28â¯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 pâ¯<â¯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 pâ¯<â¯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.
Subject(s)
Birth Weight , Hypertension, Pregnancy-Induced/epidemiology , Hypertension/epidemiology , Pre-Eclampsia/epidemiology , Pregnancy Complications, Cardiovascular/epidemiology , Premature Birth/epidemiology , Adult , Antihypertensive Agents/therapeutic use , Female , Humans , Hypertension/drug therapy , Hypertension, Pregnancy-Induced/drug therapy , Labetalol/therapeutic use , Logistic Models , Pregnancy , Pregnancy Complications, Cardiovascular/drug therapy , Prognosis , Severity of Illness IndexABSTRACT
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 100â¯mmHg) achieved BP that was 6/5mmHg higher (pâ¯<â¯0.001) than 'tight' control (target diastolic 85â¯mmHg, BP achieved 133/85â¯mmHg). 'Less tight' (vs. 'tight') control resulted in similar adverse perinatal outcomes (31.5% vs. 30.7%; pâ¯=â¯0.84) that balanced birthweightâ¯<â¯10th percentile (16.1% vs. 19.8%; pâ¯=â¯0.14) against preterm birth (35.6% vs. 31.5%; pâ¯=â¯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%; pâ¯<â¯0.001), and more women with plateletsâ¯<â¯100â¯×â¯109/L (4.3% vs. 1.6%; pâ¯=â¯0.02) or symptomatic elevated liver enzymes (4.3% vs. 1.8%; pâ¯=â¯0.03), with no difference in serious maternal complications (3.7% vs. 2.0%; pâ¯=â¯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 (pâ¯=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.
Subject(s)
Antihypertensive Agents/therapeutic use , Hypertension, Pregnancy-Induced/drug therapy , Labetalol/therapeutic use , Adult , Canada , Female , Humans , Hypertension, Pregnancy-Induced/economics , Pregnancy , Randomized Controlled Trials as Topic , Research Design , Treatment OutcomeSubject(s)
Heart Failure/complications , Heart Failure/physiopathology , Noninvasive Ventilation/statistics & numerical data , Patient Compliance/statistics & numerical data , Sleep Apnea Syndromes/complications , Sleep Apnea Syndromes/physiopathology , Adolescent , Adult , Aged , Cardiovascular Diseases , Cardiovascular System , Female , Humans , International Cooperation , Male , Middle Aged , Noninvasive Ventilation/methods , Sleep Apnea, Central , Sleep Apnea, Obstructive , Treatment Outcome , Young AdultSubject(s)
Dietary Approaches To Stop Hypertension , Renal Dialysis , Adult , Cohort Studies , HumansABSTRACT
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.
Subject(s)
Blood Pressure Determination , Blood Pressure Monitoring, Ambulatory , Hypertension , Pregnancy Complications, Cardiovascular , Preventive Health Services/methods , Adult , Antihypertensive Agents/administration & dosage , Antihypertensive Agents/classification , Blood Pressure Determination/instrumentation , Blood Pressure Determination/methods , Blood Pressure Determination/standards , Blood Pressure Monitoring, Ambulatory/instrumentation , Blood Pressure Monitoring, Ambulatory/methods , Canada , Evidence-Based Practice , Female , Health Promotion/methods , Humans , Hypertension/complications , Hypertension/diagnosis , Hypertension/therapy , Pregnancy , Pregnancy Complications, Cardiovascular/diagnosis , Pregnancy Complications, Cardiovascular/therapy , Risk Assessment/methodsABSTRACT
OBJECTIVE: Apps promoting patient self-management may improve health outcomes. However, methods to secure stored information on mobile devices may adversely affect usability. We tested the reliability and usability of common user authentication techniques in younger and older adults. METHODOLOGY: Usability testing was conducted in two age groups, 18 to 30 years and 50 years and older. After completing a demographic questionnaire, each participant tested four authentication options in random order: four-digit personal identification number (PIN), graphical password (GRAPHICAL), Android pattern-lock (PATTERN), and a swipe-style Android fingerprint scanner (FINGERPRINT). Participants rated each option using the Systems Usability Scale (SUS). RESULTS: A total of 59 older and 43 younger participants completed the study. Overall, PATTERN was the fastest option (3.44s), and PIN had the fewest errors per attempt (0.02). Participants were able to login using PIN, PATTERN, and GRAPHICAL at least 98% of the time. FINGERPRINT was the slowest (26.97s), had an average of 1.46 errors per attempt, and had a successful login rate of 85%. Overall, PIN and PATTERN had higher SUS scores than FINGERPRINT and GRAPHICAL. Compared to younger participants, older participants were also less likely to find PATTERN to be tiring, annoying or time consuming and less likely to consider PIN to be time consuming. Younger participants were more likely to rate GRAPHICAL as annoying, time consuming and tiring than older participants. CONCLUSIONS: On mobile devices, PIN and pattern-lock outperformed graphical passwords and swipe-style fingerprints. All participants took longer to authenticate using the swipe-style fingerprint compared to other options. Older participants also took two to three seconds longer to authenticate using the PIN, pattern and graphical passwords though this did not appear to affect perceived usability.
Subject(s)
Computer Security , Mobile Applications , Telemedicine , Adolescent , Adult , Female , Humans , Male , Middle Aged , Reproducibility of Results , Surveys and Questionnaires , User-Computer Interface , Young AdultABSTRACT
BACKGROUND: The rising prevalence of chronic illnesses hinders the sustainability of the health care system because of the high cost of frequent hospitalizations of patients with complex chronic conditions. Clinical trials have demonstrated that telemonitoring can improve health outcomes, but they have generally been limited to single conditions such as diabetes, hypertension, or heart failure. Few studies have examined the impact of telemonitoring on complex patients with multiple chronic conditions, although these patients may benefit the most from this technology. OBJECTIVE: The aim of this study is to investigate the impact of a smartphone-based telemonitoring system on the clinical care and health outcomes of complex patients across several chronic conditions. METHODS: A mixed-methods, 6-month randomized controlled trial (RCT) of a smartphone-based telemonitoring system is being conducted in specialty clinics. The study will include patients who have been diagnosed with one or more of any of the following conditions: heart failure, chronic obstructive pulmonary disease, chronic kidney disease, uncontrolled hypertension, or insulin-requiring diabetes. The primary outcome will be the health status of patients as measured with SF-36. Patients will be randomly assigned to either the control group receiving usual care (n=73) or the group using the smartphone-based telemonitoring system in addition to usual care (n=73). RESULTS: Participants are currently being recruited for the trial. Data collection is anticipated to be completed by the fall of 2018. CONCLUSIONS: This RCT will be among the first trials to provide evidence of the impact of telemonitoring on costs and health outcomes of complex patients who may have multiple chronic conditions. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 41238563; http://www.isrctn.com/ISRCTN41238563 (Archived by WebCite at http://www.webcitation.org/6ug2Sk0af) and Clinicaltrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852 (Archived by WebCite at http://www.webcitation.org/6uvjNosBC).
ABSTRACT
STUDY OBJECTIVES: In heart failure (HF), we observed two patterns of hyperpnea during Cheyne-Stokes respiration with central sleep apnea (CSR-CSA): a positive pattern where end-expiratory lung volume remains at or above functional residual capacity, and a negative pattern where it falls below functional residual capacity. We hypothesized the negative pattern is associated with worse HF. METHODS: Patients with HF underwent polysomnography. During CSR-CSA, hyperpnea, apnea-hyperpnea cycle, and lung to finger circulation times (LFCT) were measured. Plasma N-terminal prohormone of brain natriuretic peptide (NT-proBNP) concentration and left ventricular ejection fraction (LVEF) were assessed. RESULTS: Of 33 patients with CSR-CSA (31 men, mean age 68 years), 9 had a negative hyperpnea pattern. There was no difference in age, body mass index, and apnea-hypopnea index between groups. Patients with a negative pattern had longer hyperpnea time (39.5 ± 6.4 versus 25.8 ± 5.9 seconds, P < .01), longer cycle time (67.8 ± 15.9 versus 51.7 ± 9.9 seconds, P < .01), higher NT-proBNP concentrations (2740 [6769] versus 570 [864] pg/ml, P = .01), and worse New York Heart Association class (P = .02) than those with a positive pattern. LFCT and LVEF did not differ between groups. CONCLUSIONS: Patients with HF and a negative CSR-CSA pattern have evidence of worse cardiac function than those with a positive pattern. Greater positive expiratory pressure during hyperpnea is likely generated during the negative pattern and might support stroke volume in patients with worse cardiac function. COMMENTARY: A commentary on this article appears in this issue on page 1227. CLINICAL TRIAL REGISTRATION: The trial is registered with Current Controlled Trials (www.controlled-trials.com; ISRCTN67500535) and Clinical Trials (www.clinicaltrials.gov; NCT01128816).