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1.
Australas Psychiatry ; : 10398562211022748, 2021 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-34126787

RESUMO

OBJECTIVE: COVID-19 propelled e-mental health within the Australian health system. It is important to learn from this to inform mental healthcare during future crises. METHOD: A lexical analysis was conducted of clinician reflections during COVID-19 as they delivered psychiatry services to children and families in New South Wales (n = 6) and transitioned to e-mental health. RESULTS: E-mental health can extend the reach of, and access to psychiatry services, particularly for individuals disadvantaged by inequity. Yet e-mental health can be problematic. It is partly contingent on technological prowess, equipment, internet access as well as space and privacy. Relatedly, e-mental health can hinder clinician capacity to conduct examinations, monitor child development as well as assess risk and the need for child protection. CONCLUSIONS: Given the benefits and limitations of e-mental health, a model that supports face-to-face mental healthcare and e-mental health may be of value. This model would require practical, yet flexible policies and protocols that protect the privacy of children and families, safeguard them from harm, and respect the needs and preferences of children, families and clinicians.

2.
Clin Cardiol ; 2021 Jun 08.
Artigo em Inglês | MEDLINE | ID: mdl-34101211

RESUMO

BACKGROUND: Women with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention historically experience worse in-hospital outcomes compared to men. HYPOTHESIS: Implementation of a regional STEMI system will reduce care gaps in reperfusion times and in-hospital outcomes between women and men. METHODS: 1928 patients (413 women, 21.4%) presented with an acute STEMI between June 2007 and March 2016. The population was divided into an early cohort (n = 728 patients, 2007-May 2011), and a late cohort (n = 1200 patients, June 2011-2016). The primary endpoints evaluated were reperfusion times and in-hospital outcomes. RESULTS: Compared to men, women experienced significant delays in first medical contact (FMC) to arrival at the emergency room (26.0 vs. 22.0 min, p < 0.001) and FMC-to-device (109 vs. 101 min p = 0.001). Women had higher incidences of post-PCI heart failure and death compared to men (p < 0.05). Following multivariable adjustment, no mortality difference was observed for women versus men (adjusted OR; 0.82; 95% confidence interval [CI], 0.51-1.34; p = 0.433) or for early versus late cohorts (adjusted OR; 1.04; 95% CI, 0.68-1.60; p = 0.856). CONCLUSION: Following STEMI regionalization, women continued to experience significantly longer reperfusion times, although there was no difference in adjusted mortality. These results highlight the ongoing disparity of STEMI care between women and men, and suggest that regionalization alone is insufficient to close sex-based care gaps.

3.
Artigo em Inglês | MEDLINE | ID: mdl-34124856

RESUMO

OBJECTIVE: To determine whether a Mediterranean-style ketogenic diet mobile health application (app) with breath acetone biofeedback is superior to a calorie-restricted low-fat diet app in promoting weight loss. METHODS: Participants (N = 155) with overweight/obesity (mean±SD: 41±11 y, BMI = 34±5 kg/m2 , 71% female) were randomized to one of the interventions that were delivered entirely via app. Participants received a wireless scale and were instructed to take daily weight measurements. A third-party laboratory collected blood samples at baseline and 12 weeks. RESULTS: Weight loss at 12 weeks was greater in the ketogenic (-5.6 kg; 95% CI, -6.7 kg to -4.5 kg) compared to the low-fat group (-2.5 kg; 95% CI, -3.6 kg to -1.4 kg) (between-group difference: -3.1 kg; 95% CI, -4.6 kg to -1.5 kg; p < 0.001). Weight loss at 24 weeks indicated durability of the effect (between-group difference: -5.5 kg; 95% CI, -8.3 kg to -2.8 kg; p < 0.001). Secondary/exploratory outcomes of HbA1c and liver enzymes were improved to a greater extent in the ketogenic diet group (p < 0.01). CONCLUSIONS: Among adults with overweight/obesity, a ketogenic diet app with breath acetone biofeedback was superior to a calorie-restricted diet app at promoting weight loss in a real-world setting.

4.
JMIR Mhealth Uhealth ; 9(5): e24530, 2021 05 14.
Artigo em Inglês | MEDLINE | ID: mdl-33988519

RESUMO

BACKGROUND: Acute coronary syndrome (ACS) is a leading cause of hospital admission in North America. Many patients with ACS experience challenges after discharge that impact their clinical outcomes and psychosocial well-being. SMS text messaging has the potential to provide support to patients during this postdischarge period. OBJECTIVE: This study pilot tested a 60-day SMS text messaging intervention (Txt2Prevent) for patients with ACS. The primary objective was to compare self-management domains between usual care and usual care plus Txt2Prevent. The secondary objectives were to compare medication adherence, health-related quality of life, self-efficacy, and health care resource use between groups. The third objective was to assess the feasibility of the study protocol and the acceptability of the intervention. METHODS: This was a randomized controlled trial with blinding of outcome assessors. We recruited 76 patients with ACS from St. Paul's Hospital in Vancouver, Canada, and randomized them to 1 of 2 groups within 7 days of discharge. The Txt2Prevent program included automated 1-way SMS text messages about follow-up care, self-management, and healthy living. Data were collected during the index admission and at 60 days after randomization. The primary outcome was measured with the Health Education Impact Questionnaire (heiQ). Other outcomes included the EQ-5D-5L, EQ-5D-5L Visual Analog Scale, a modified Sullivan Cardiac Self-Efficacy Scale, and Morisky Medication Adherence Scale scores, and self-reported health care resource use. Analyses of covariance were used to test the effect of group assignment on follow-up scores (controlling for baseline) and were considered exploratory in nature. Feasibility was assessed with descriptive characteristics of the study protocol. Acceptability was assessed with 2 survey questions and semistructured interviews. RESULTS: There were no statistically significant differences between the groups for the heiQ domains (adjusted mean difference [Txt2Prevent minus usual care] for each domain-Health-directed activity: -0.13, 95% CI -0.39 to 0.13, P=.31; Positive and active engagement in life: 0.03, 95% CI -0.19 to 0.25, P=.76; Emotional distress: 0.04, 95% CI -0.22 to 0.29, P=.77; Self-monitoring and insight: -0.14, 95% CI -0.33 to 0.05, P=.15; Constructive attitudes and approaches: -0.10, 95% CI -0.36 to 0.17, P=.47; Skill technique and acquisition: 0.05, 95% CI -0.18 to 0.27, P=.69; Social integration and support: -0.12, 95% CI -0.34 to 0.10, P=.27; and Health services navigation: -0.05, 95% CI -0.29 to 0.19, P=.69). For the secondary outcomes, there were no statistically significant differences in adjusted analyses except in 1 self-efficacy domain (Total plus), where the Txt2Prevent group had lower scores (mean difference -0.36, 95% CI -0.66 to -0.50, P=.03). The study protocol was feasible, but recruitment took longer than expected. Over 90% (29/31 [94%]) of participants reported they were satisfied with the program. CONCLUSIONS: The Txt2Prevent study was feasible to implement; however, although exploratory, there were no differences between the 2 groups in adjusted analyses except for 1 self-efficacy domain. As the intervention appeared acceptable, there is potential in using SMS text messages in this context. The design of the intervention may need to be reconsidered to have more impact on outcome measures. TRIAL REGISTRATION: ClinicalTrials.gov NCT02336919; https://clinicaltrials.gov/ct2/show/NCT02336919. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.6968.


Assuntos
Síndrome Coronariana Aguda , Envio de Mensagens de Texto , Síndrome Coronariana Aguda/tratamento farmacológico , Assistência ao Convalescente , Canadá , Hospitais , Humanos , Alta do Paciente , Projetos Piloto , Qualidade de Vida
5.
Crit Care Med ; 2021 Apr 19.
Artigo em Inglês | MEDLINE | ID: mdl-33870918

RESUMO

OBJECTIVES: Severe acute respiratory syndrome-related coronavirus-2 binds and inhibits angiotensin-converting enzyme-2. The frequency of acute cardiac injury in patients with coronavirus disease 2019 is unknown. The objective was to compare the rates of cardiac injury by angiotensin-converting enzyme-2-binding viruses from viruses that do not bind to angiotensin-converting enzyme-2. DATA SOURCES: We performed a systematic review of coronavirus disease 2019 literature on PubMed and EMBASE. STUDY SELECTION: We included studies with ten or more hospitalized adults with confirmed coronavirus disease 2019 or other viral pathogens that described the occurrence of acute cardiac injury. This was defined by the original publication authors or by: 1) myocardial ischemia, 2) new cardiac arrhythmia on echocardiogram, or 3) new or worsening heart failure on echocardiogram. DATA EXTRACTION: We compared the rates of cardiac injury among patients with respiratory infections with viruses that down-regulate angiotensin-converting enzyme-2, including H1N1, H5N1, H7N9, and severe acute respiratory syndrome-related coronavirus-1, to those with respiratory infections from other influenza viruses that do not bind angiotensin-converting enzyme-2, including Influenza H3N2 and influenza B. DATA SYNTHESIS: Of 57 studies including 34,072 patients, acute cardiac injury occurred in 50% (95% CI, 44-57%) of critically ill patients with coronavirus disease 2019. The overall risk of acute cardiac injury was 21% (95% CI, 18-26%) among hospitalized patients with coronavirus disease 2019. In comparison, 37% (95% CI, 26-49%) of critically ill patients with other respiratory viruses that bind angiotensin-converting enzyme-2 (p = 0.061) and 12% (95% CI, 7-22%) of critically ill patients with other respiratory viruses that do not bind angiotensin-converting enzyme-2 (p < 0.001) experienced a cardiac injury. CONCLUSIONS: Acute cardiac injury may be associated with whether the virus binds angiotensin-converting enzyme-2. Acute cardiac injury occurs in half of critically ill coronavirus disease 2019 patients, but only 12% of patients infected by viruses that do not bind to angiotensin-converting enzyme-2.

6.
Can J Cardiol ; 2021 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-33839244

RESUMO

BACKGROUND: One of the most common fetal complications in pregnant women with cardiovascular disease is small for gestational age (SGA) which is associated with a higher risk of perinatal morbidity/mortality and poor long-term health outcomes. The objective of this study was to identify cardiac determinants/derive a risk score of clinically relevant SGA < 5th percentile (SGA-5th). METHODS: A prospective cohort of 1812 pregnancies in women with heart disease was studied. SGA-5th was the outcome of interest, defined as birth weight less than 5th percentile for gestational age and sex. Multivariable logistic regression analysis identified predictors for SGA-5th. Based on the regression coefficients a weighted risk score was created. RESULTS: SGA-5th complicated 10% of pregnancies, eleven predictors of SGA-5th were identified and each was assigned a weighted score: maternal cyanosis (8), Fontan palliation (7), smoking (3), moderate or severe valvular regurgitation (3), beta-blocker use throughout pregnancy (4) or only in the 2nd and 3rd trimester (2), high baseline beta-blocker dose (4), BMI < 18.5 (3) or 18.5-24.9 (1), Asian/other ethnicity (2) and significant outflow tract obstruction (1). In the absence of identified risk factors, the risk of SGA-5th was approximately 4%. Pregnancies with risk scores/SGA-5th rate were as follows: 0/4%, 1/5%, 2/7%, 3/9%, 4/12%, 5/14%, 6/18%, 7/23%, 8/28% and ≥ 9/34%. CONCLUSIONS: There are a number of cardiac predictors that are associated with increased risk of SGA-5th. This is a prognostically important outcome and consideration should be given to routinely predicting and modifying the risk whenever possible.

7.
Lancet Public Health ; 6(5): e324-e334, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33857455

RESUMO

BACKGROUND: The synchronised monthly disbursement of income assistance, whereby all recipients are paid on the same day, has been associated with increases in illicit drug use and serious associated harms. This phenomenon is often referred to as the cheque effect. Because payment variability can affect consumption patterns, this study aimed to assess whether these harms could be mitigated through a structural intervention that varied income assistance payment timing and frequency. METHODS: This randomised, parallel group trial was done in Vancouver, Canada, and enrolled recipients of income assistance whose drug use increased around payment days. The recipients were randomly assigned 1:2:2 to a control group that received monthly synchronised income assistance payments on government payment days, a staggered group in which participants received single desynchronised monthly income assistance payments, or a split and staggered group in which participants received desynchronised income assistance payments split into two instalments per month, 2 weeks apart, for six monthly payment cycles. Desynchronised payments in the intervention groups were made on individual payment days outside the week of the standard government schedules. Randomisation was through a pre-established stratified block procedure. Investigators and statisticians were masked to group allocation, but participants and front-line staff were not. Complete final results are reported after scheduled interim analyses and the resulting early stoppage of recruitment. Under intention-to-treat specifications, generalised linear mixed models were used to analyse the primary outcome, which was escalations in drug use, predefined as a 40% increase in at least one of: use frequency; use quantity; or number of substances used during the 3 days after government payments. Secondary analyses examined analogous drug use outcomes coinciding with individual payments as well as exposure to violence. This trial is registered with ClinicalTrials.gov, NCT02457949. FINDINGS: Between Oct 27, 2015, and Jan 2, 2019, 45 participants were enrolled to the control group, 72 to the staggered group, and 77 to the split and staggered group. Intention-to-treat analyses showed a significantly reduced likelihood of increased drug use coinciding with government payment days, relative to the control group, in the staggered (adjusted odds ratio 0·38, 95% CI 0·20-0·74; p=0·0044) and split and staggered (0·44, 0·23-0·83; p=0·012) groups. Findings were consistent in the secondary analyses of drug use coinciding with individual payment days (staggered group 0·50, 0·27-0·96, p=0·036; split and staggered group 0·49, 0·26-0·94, p=0·030). However, secondary outcome analyses of exposure to violence showed increased harm in the staggered group compared with the control group (2·71, 1·06-6·91, p=0·037). Additionally, 51 individuals had a severe or life-threatening adverse event and there were six deaths, none of which was directly attributed to study participation. INTERPRETATION: Complex results indicate the potential for modified income assistance payment schedules to mitigate escalations in drug use, provided measures to address unintended harms are also undertaken. Additional research is needed to clarify whether desynchronised schedules produce other unanticipated consequences and if additional measures could mitigate these harms. FUNDING: Canadian Institutes of Health Research, Providence Health Care Research Institute, Peter Wall Institute for Advanced Research, Michael Smith Foundation for Health Research.


Assuntos
Assistência Pública/estatística & dados numéricos , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Adulto , Canadá/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Tempo
9.
Resuscitation ; 159: 105-114, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33385471

RESUMO

STUDY OBJECTIVE: Post-resuscitation prognostic biomarkers for out-of-hospital cardiac arrest (OHCA) outcomes have not been fully elucidated. We examined the association of acid-base blood values (pH) with patient outcomes and calculated the pH test performance to predict prognosis. METHODS: This was a post-hoc analysis of data from the continuous chest compression trial, which enrolled non-traumatic adult emergency medical system-treated OHCA in Canada and the United States. We examined cases who survived a minimum of 24 h post hospital arrival. The independent variables of interest were initial pH, final pH, and the change in pH (δpH). The primary outcome was neurological status at hospital discharge, with favorable status defined as modified Rankin Scale (mRS) ≤ 3. We reported adjusted odds ratios for favorable neurological outcome using multivariable logistic regression models. We calculated the test performance of increasing pH thresholds in 0.1 increments to predict unfavorable neurological status (defined as mRS >3) at hospital discharge. RESULTS: We included 4189 patients. 32% survived to hospital discharge with favorable neurological status. In the adjusted analysis, higher initial pH (OR 6.82; 95% CI 3.71-12.52) and higher final pH (OR 7.99; 95% CI 3.26-19.62) were associated with higher odds of favorable neurological status. pH thresholds with highest positive predictive values were initial pH < 6.8 (92.5%; 95% CI 86.2 %-98.8%) and final pH < 7.0 (100%; 95% CI 95.2 %-100%). CONCLUSION: In patients with OHCA, pH values were associated with patients' subsequent neurological status at hospital discharge. Final pH may be clinically useful to predict unfavorable neurological status at hospital discharge.

10.
Can J Kidney Health Dis ; 7: 2054358120970093, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33294204

RESUMO

Purpose of program: Traditionally, peer review was a closed process conducted only by individuals working in the research field. To establish a more integrated and patient-centered approach, one of Canada's largest kidney research networks (Can-SOLVE CKD) has created a Research Operations Committee (ROC) that includes patients as key members. The ROC represents one way for achieving meaningful patient-oriented research (POR). Source of information: Can-SOLVE CKD, a network created as part of the Canadian Institutes of Health Research (CIHR) Strategy for Patient-Oriented Research (SPOR). Methods: The ROC consists of patients, physicians, scientists, Indigenous partners, experts in research methodology, and a member of Can-SOLVE CKD's operational team. On an annual basis, Can-SOLVE CKD's research teams provide the ROC with a review package, which incorporates information from patient engagement check-in calls and surveys, the project's knowledge translation plan and products, and a progress report written by the project team. The ROC evaluates the review package and provides feedback and recommendations accordingly. Key findings: The transparent nature of the process, regular feedback and review, along with an overt accountability and scoring system, has been embraced by both patients and researchers. As a result of the ROC process, the number of patient leads for each project has grown over a 3-year period and more researchers have received POR and cultural sensitivity training. Limitations: While anecdotal evidence suggests this approach is beneficial for achieving POR, formal mechanisms of evaluation are currently lacking. Implications: This ROC framework ensures patients are active contributors throughout the research process and could be adopted by other organizations to achieve a more patient-centered approach to research.

11.
BMJ Open ; 10(12): e040768, 2020 12 07.
Artigo em Inglês | MEDLINE | ID: mdl-33293316

RESUMO

INTRODUCTION: The COVID-19 epidemic grows and there are clinical trials of antivirals. There is an opportunity to complement these trials with investigation of angiotensin II type 1 receptor blockers (ARBs) because an ARB (losartan) was effective in murine influenza pneumonia. METHODS AND ANALYSIS: Our innovative design includes: ARBs; alignment with the WHO Ordinal Scale (primary endpoint) to align with other COVID-19 trials; joint longitudinal analysis; and predictive biomarkers (angiotensins I, 1-7, II and ACE1 and ACE2). Our hypothesis is: ARBs decrease the need for hospitalisation, severity (need for ventilation, vasopressors, extracorporeal membrane oxygenation or renal replacement therapy) or mortality of hospitalised COVID-19 infected adults. Our two-pronged multicentre pragmatic observational cohort study examines safety and effectiveness of ARBs in (1) hospitalised adult patients with COVID-19 and (2) out-patients already on or not on ARBs. The primary outcome will be evaluated by ordinal logistic regression and main secondary outcomes by both joint longitudinal modelling analyses. We will compare rates of hospitalisation of ARB-exposed versus not ARB-exposed patients. We will also determine whether continuing ARBs or not decreases the primary outcome. Based on published COVID-19 cohorts, assuming 15% of patients are ARB-exposed, a total sample size of 497 patients can detect a proportional OR of 0.5 (alpha=0.05, 80% power) comparing WHO scale of ARB-exposed versus non-ARB-exposed patients. ETHICS AND DISSEMINATION: This study has core institution approval (UBC Providence Healthcare Research Ethics Board) and site institution approvals (Health Research Ethics Board, University of Alberta; Comite d'etique de la recerche, CHU Sainte Justine (for McGill University and University of Sherbrook); Conjoint Health Research Ethics Board, University of Calgary; Queen's University Health Sciences & Affiliated Hospitals Research Ethics Board; Research Ethics Board, Sunnybrook Health Sciences Centre; Veritas Independent Research Board (for Humber River Hospital); Mount Sinai Hospital Research Ethics Board; Unity Health Toronto Research Ethics Board, St. Michael's Hospital). Results will be disseminated by peer-review publication and social media releases. TRIAL REGISTRATION NUMBER: NCT04510623.

12.
BJOG ; 2020 Nov 23.
Artigo em Inglês | MEDLINE | ID: mdl-33230924

RESUMO

OBJECTIVE: To examine the relationship between pre-eclampsia definition and pregnancy outcome. DESIGN: Secondary analysis of CHIPS trial data. SETTING: International multi-centre RCT. POPULATION: 987 women with non-severe non-proteinuric pregnancy hypertension. METHODS: We evaluated the relationship between pre-eclampsia definitions and adverse pregnancy outcomes, stratified by hypertension type and blood pressure control. MAIN OUTCOME MEASURES: Main CHIPS trial outcomes: primary (perinatal loss or high-level neonatal care for >48hr), secondary (serious maternal complications), birth weight <10th centile, severe maternal hypertension, delivery at <34 or <37 weeks, and maternal hospitalisation before birth. RESULTS: Of 979/987 women with informative data, 280 (28.6%) progressed to pre-eclampsia defined restrictively by new proteinuria, and 471 (48.1%) to pre-eclampsia defined broadly as proteinuria or one/more maternal symptoms, signs, or abnormal laboratory tests. The broad (vs. restrictive) definition had significantly higher sensitivities (range 62-79% vs. 36-50%), lower specificities (range 53-65% vs. 72-82%), and similar or higher DOR and 'true' to 'false' positives ratios. Stratified analyses showed similar results. Addition of available fetoplacental manifestations (stillbirth or birthweight <10th centile) to the broad pre-eclampsia definition improved sensitivity (74-87%). CONCLUSIONS: A broad (vs. restrictive) pre-eclampsia definition better identifies women who develop adverse pregnancy outcomes. These findings should be replicated in a prospective study within routine health care to ensure that the anticipated increase in surveillance and intervention in a larger number of women with pre-eclampsia is associated with improved outcomes, reasonable costs, and congruence with women's values.

13.
Am Heart J ; 229: 18-28, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32916606

RESUMO

Despite evidence that high-sensitivity cardiac troponin (hs-cTn) levels in women are lower than in men, a single threshold based on the 99th percentile upper reference limit of the overall reference population is commonly used to diagnose myocardial infarction in clinical practice. This trial aims to determine whether the use of a lower female-specific hs-cTn threshold would improve the diagnosis, treatment, and outcomes of women presenting to the emergency department with symptoms suggestive of myocardial ischemia. METHODS/DESIGN: CODE-MI (hs-cTn-Optimizing the Diagnosis of Acute Myocardial Infarction/Injury in Women) is a multicenter, stepped-wedge, cluster-randomized trial of 30 secondary and tertiary care hospitals across 8 Canadian provinces, with the unit of randomization being the hospital. All adults (≥20 years of age) presenting to the emergency department with symptoms suggestive of myocardial ischemia and at least 1 hs-cTn test are eligible for inclusion. Over five, 5-month intervals, hospitals will be randomized to implement lower female hs-cTn thresholds according to the assay being used at each site. Men will continue to be assessed using the overall thresholds throughout. Women with a peak hs-cTn value between the female-specific and the overall thresholds will form our primary cohort. The primary outcome, a 1-year composite of all-cause mortality or readmission for nonfatal myocardial infarction, incident heart failure, or emergent/urgent coronary revascularization, will be compared before and after the implementation of female thresholds using mixed-effects logistic regression models. The cohort and outcomes will be obtained from routinely collected administrative data. The trial is designed to detect a 20% relative risk difference in the primary outcome, or a 2.2% absolute difference, with 82% power. CONCLUSIONS: This pragmatic trial will assess whether adopting lower female hs-cTn thresholds leads to appropriate assessment of women with symptoms suggestive of myocardial infarction, thereby improving treatment and outcomes.

14.
JMIR Res Protoc ; 9(8): e19053, 2020 Aug 17.
Artigo em Inglês | MEDLINE | ID: mdl-32804087

RESUMO

BACKGROUND: Obesity and being overweight are major contributing factors for many diseases. Calorie restricted diets often fail to result in sustained long-term weight loss. Very low-carbohydrate, high-fat ketogenic diets have been suggested to have superior metabolic and weight loss effects. Keyto is a low-cost, highly scalable mobile health (mHealth) app paired with a noninvasive biofeedback tool aimed at facilitating weight loss through a personalized healthy and predominantly plant- and fish-based ketogenic diet. OBJECTIVE: This protocol describes a randomized trial comparing the efficacy of the Keyto mHealth app and device intervention to that of Weight Watchers' WW app in individuals who are overweight or obese. The primary outcome is weight loss after 12 weeks. Secondary and exploratory outcomes, including metabolic and cardiovascular risk factors, will be assessed at 12, 24, and 48 weeks. METHODS: A total of 144 participants will be recruited and randomized to either the Keyto program or Weight Watchers program. Study participants will be guided through the study via video conference or phone calls and will undergo a fasting blood analysis performed by a third-party diagnostic lab at weeks 0 and 12 to assess metabolic and cardiovascular risk markers. All participants will be asked to weigh themselves daily on a study-provided Bluetooth-enabled scale. Participants randomized to the Keyto arm will also be asked to measure their breath acetone levels, a measure of ketosis, with the Keyto device 3 times per day. RESULTS: Recruitment started in December 2019. Rolling recruitment is expected to be completed by July 2020. Data collection and analysis of the primary intervention phase is expected to be completed in October 2020. The 24- and 48-week follow-ups are expected to be completed in January 2021 and July 2021, respectively. CONCLUSIONS: This trial will provide high-quality evidence regarding the efficacy of the Keyto weight loss program in individuals who are overweight and obese in a free-living condition. This study also fills a gap by examining the impact of a ketogenic diet emphasizing plant- and fish-based fats on blood lipid profile and cardiovascular disease risk. TRIAL REGISTRATION: ClinicalTrials.gov NCT04165707; https://clinicaltrials.gov/ct2/show/NCT04165707. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19053.

15.
Pregnancy Hypertens ; 22: 109-118, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32777710

RESUMO

OBJECTIVES: To reduce all-cause maternal and perinatal mortality and major morbidity through Lady Health Worker (LHW)-facilitated community engagement and early diagnosis, stabilization and referral of women with preeclampsia, an important contributor to adverse maternal and perinatal outcomes given delays in early detection and initial management. STUDY DESIGN: In the Pakistan Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial (NCT01911494), LHWs engaged the community, recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization. MAIN OUTCOME MEASURES: The primary outcome was a composite of maternal, fetal and newborn mortality and major morbidity. FINDINGS: We recruited 39,446 women in intervention (N = 20,264) and control clusters (N = 19,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively). The primary outcome did not differ between intervention (26·6%) and control (21·9%) clusters (adjusted odds ratio, aOR, 1∙20 [95% confidence interval 0∙84-1∙72]; p = 0∙31). There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77); early (0·95 [0·82-1·09]; p = 0·46) or late neonatal deaths (1·23 [0·97-1·55]; p = 0·09); or neonatal morbidity (1·22 [0·77, 1·96]; p = 0·40). Improvements in outcome rates were observed with 4-7 (p = 0·015) and ≥8 (p < 0·001) (vs. 0) CLIP contacts. INTERPRETATION: The CLIP intervention was well accepted by the community and implemented by LHWs. Lack of effects on adverse outcomes could relate to quality care for mothers with pre-eclampsia in health facilities. Future strategies for community outreach must also be accompanied by health facility strengthening. FUNDING: The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).

16.
Lancet ; 396(10250): 553-563, 2020 08 22.
Artigo em Inglês | MEDLINE | ID: mdl-32828187

RESUMO

BACKGROUND: To overcome the three delays in triage, transport and treatment that underlie adverse pregnancy outcomes, we aimed to reduce all-cause adverse outcomes with community-level interventions targeting women with pregnancy hypertension in three low-income countries. METHODS: In this individual participant-level meta-analysis, we de-identified and pooled data from the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trials in Mozambique, Pakistan, and India, which were run in 2014-17. Consenting pregnant women, aged 12-49 years, were recruited in their homes. Clusters, defined by local administrative units, were randomly assigned (1:1) to intervention or control groups. The control groups continued local standard of care. The intervention comprised community engagement and existing community health worker-led mobile health-supported early detection, initial treatment, and hospital referral of women with hypertension. For this meta-analysis, as for the original studies, the primary outcome was a composite of maternal or perinatal outcome (either maternal, fetal, or neonatal death, or severe morbidity for the mother or baby), assessed by unmasked trial surveillance personnel. For this analysis, we included all consenting participants who were followed up with completed pregnancies at trial end. We analysed the outcome data with multilevel modelling and present data with the summary statistic of adjusted odds ratios (ORs) with 95% CIs (fixed effects for maternal age, parity, maternal education, and random effects for country and cluster). This meta-analysis is registered with PROSPERO, CRD42018102564. FINDINGS: Overall, 44 clusters (69 330 pregnant women) were randomly assigned to intervention (22 clusters [36 008 pregnancies]) or control (22 clusters [33 322 pregnancies]) groups. 32 290 (89·7%) pregnancies in the intervention group and 29 698 (89·1%) in the control group were followed up successfully. Median maternal age of included women was 26 years (IQR 22-30). In the intervention clusters, 6990 group and 16 691 home-based community engagement sessions and 138 347 community health worker-led visits to 20 819 (57·8%) of 36 008 women (of whom 11 095 [53·3%] had a visit every 4 weeks) occurred. Blood pressure and dipstick proteinuria were assessed per protocol. Few women were eligible for methyldopa for severe hypertension (181 [1%] of 20 819) or intramuscular magnesium sulfate for pre-eclampsia (198 [1%]), of whom most accepted treatment (162 [89·5%] of 181 for severe hypertension and 133 [67·2%] of 198 for pre-eclampsia). 1255 (6%) were referred to a comprehensive emergency obstetric care facility, of whom 864 (82%) accepted the referral. The primary outcome was similar in the intervention (7871 [24%] of 32 290 pregnancies) and control clusters (6516 [22%] of 29 698; adjusted OR 1·17, 95% CI 0·90-1·51; p=0·24). No intervention-related serious adverse events occurred, and few adverse effects occurred after in-community treatment with methyldopa (one [2%] of 51; India only) and none occurred after in-community treatment with magnesium sulfate or during transport to facility. INTERPRETATION: The CLIP intervention did not reduce adverse pregnancy outcomes. Future community-level interventions should expand the community health worker workforce, assess general (rather than condition-specific) messaging, and include health system strengthening. FUNDING: University of British Columbia, a grantee of the Bill & Melinda Gates Foundation.


Assuntos
Pré-Eclâmpsia/epidemiologia , Resultado da Gravidez/epidemiologia , Adolescente , Adulto , Criança , Serviços de Saúde Comunitária/normas , Feminino , Humanos , Índia/epidemiologia , Morte Materna/estatística & dados numéricos , Pessoa de Meia-Idade , Moçambique/epidemiologia , Paquistão/epidemiologia , Pré-Eclâmpsia/diagnóstico , Pré-Eclâmpsia/terapia , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto Jovem
17.
Trials ; 21(1): 593, 2020 Jun 29.
Artigo em Inglês | MEDLINE | ID: mdl-32600389

RESUMO

BACKGROUND: Sickle cell disease (SCD) is a genetic disorder which causes dysfunctional red blood cells (RBC) and is thought to increase requirements for folate, an essential B vitamin, due to increased RBC production and turnover in the disease. High-dose supplementation with 1-5 mg/d folic acid, synthetic folate, has been the standard recommendation for children with SCD. There is concern about whether children with SCD need such high doses of folic acid, following mandatory folic acid fortification of enriched grains in Canada, and advancements in medical therapies which extend the average lifespan of RBCs. In animal and human studies, high folic acid intakes (1 mg/d) have been associated with accelerated growth of some cancers, and the biological effects of circulating unmetabolized folic acid (UMFA), which can occur with doses of folic acid ≥ 0.2 mg/d, are not fully understood. The objective of this study is to determine efficacy of, and alterations in folate metabolism from high-dose folic acid in children with SCD during periods of folic acid supplementation versus no supplementation. METHODS: In this double-blind randomized controlled cross-over trial, children with SCD (n = 36, aged 2-19 years) will be randomized to either receive 1 mg/d folic acid, the current standard of care, or a placebo for 12 weeks. After a 12-week washout period, treatments will be reversed. Total folate concentrations (serum and RBC), different folate forms (including UMFA), folate-related metabolites, and clinical outcomes will be measured at baseline and after treatment periods. The sum of the values measured in the two periods will be calculated for each subject and compared across the two sequence groups by means of a test for independent samples for the primary (RBC folate concentrations) and secondary (UMFA) outcomes. Dietary intake will be measured at the beginning of each study period. DISCUSSION: As the first rigorously designed clinical trial in children with SCD, this trial will inform and assess current clinical practice, with the ultimate goal of improving nutritional status of children with SCD. TRIAL REGISTRATION: ClinicalTrials.gov NCT04011345 . Registered on July 8, 2019.

19.
BMC Musculoskelet Disord ; 21(1): 467, 2020 Jul 16.
Artigo em Inglês | MEDLINE | ID: mdl-32677938

RESUMO

BACKGROUND: To evaluate whether knee osteoarthritis (OA) manifestations predict depression and anxiety using cross-sectional and longitudinal prediction models. METHODS: A population-based cohort (n = 122) with knee pain, aged 40-79, was evaluated at baseline, 3 and 7 years. Baseline predictors were: age decade; sex; BMI ≥ 25; physical exam knee effusion; crepitus; malalignment; quadriceps atrophy; flexion; flexion contracture; Kellgren-Lawrence (KL) x-ray grade (0/1/2/3+); WOMAC pain ≥25; WOMAC stiffness ≥25; self-reported knee swelling; and knee OA diagnosis (no/probable/definite). Depression and anxiety, cutoffs 5+ and 7+ respectively, were measured via the Hospital Anxiety and Depression Scale. We fit logistic models at each cycle using multivariable models selected via lowest Akaike's information criterion. RESULTS: Baseline depression model: sex (female OR = 0.27; 0.10, 0.76) and KL grade (KL 1 OR = 4.21; 1.31, 13.48). Three-year depression model: KL grade (KL 1 OR = 18.92; 1.73, 206.25). Seven-year depression model: WOMAC stiffness ≥25 (OR = 3.49; 1.02, 11.94) and flexion contracture ≥1 degree (OR = 0.23; 0.07, 0.81). Baseline anxiety model: knee swelling (OR = 4.11; 1.51, 11.13) and age (50-59 vs. 40-49 OR = 0.31 [0.11, 0.85]; 60-69 OR = 0.07 [0.01, 0.42]). Three-year anxiety model: WOMAC stiffness ≥25 (OR = 5.80; 1.23, 27.29) and KL grade (KL 1 OR = 6.25; 1.04, 37.65). Seven-year anxiety model: sex (female OR = 2.71; 0.87, 8.46). CONCLUSION: Specific knee OA-related manifestations predict depression and anxiety cross-sectionally, 3 years in the future, and for depression, 7 years in the future. This information may prove useful to clinicians in helping to identify patients most at risk of present or future depression and anxiety, thus facilitating preemptive discussions that may help counter that risk.

20.
Ann Otol Rhinol Laryngol ; 129(11): 1063-1070, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32484033

RESUMO

OBJECTIVES: To assess voice outcomes using the novel technique of in-office laryngeal electromyography-guided vocal fold injections (LEVFI) with hyaluronic acid to treat glottal insufficiency. Secondary objectives included determining the complication/completion rates and if any factors were associated with improved voice outcomes. METHODS: Retrospective review of patients who received their first LEVFI from August 2017 to December 2018. Three- and six-month voice outcomes were assessed. Outcomes included voice handicap index-10 (VHI-10), maximum phonation time (MPT), perceptual analysis of voice (GRBAS), fundamental frequency, and stroboscopy. RESULTS: Of the 121 eligible patients (55.4% male, age 63.7 years), 94 (77.7%) had complete 3-month data and 59 (48.8%) had complete 6-month data. VHI-10 was significantly improved from 25.7 ± 7.5 to 20.9 ± 10.9 at 3 months (P < .001) and to 19.1 ± 11.5 at 6 months (P < .001). MPT improved from 6.2 ± 5.4 seconds to 9.4 ± 7.1 seconds at 3 months (P < .001) and to 11.3 ± 8.2 seconds at 6 months (P < .001). GRBAS was improved in 74.8% of patients ([65.2, 82.8] 95% CI) at 3 months and 80.8% ([69.9, 89.1]) 95% CI) at 6 months. Stroboscopy showed a glottic gap improvement in 74.8% of patients ([65.8, 82.4] 95% CI) at 3 months and in 80.3% ([65.9, 88.5] 95% CI) at 6 months. Fundamental frequency was unchanged, as expected. Multivariate analysis reported that no factors were associated with better voice outcomes. Overall, 177/181 (97.8%) injections were completed. There were no complications. CONCLUSION: In-office LEVFI is an effective, novel technique to treat glottic insufficiency with improved voice outcomes, high completion rate, and no significant complications.


Assuntos
Eletromiografia/métodos , Ácido Hialurônico/administração & dosagem , Laringoplastia/métodos , Paralisia das Pregas Vocais/diagnóstico , Qualidade da Voz/fisiologia , Feminino , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Viscossuplementos/administração & dosagem , Paralisia das Pregas Vocais/fisiopatologia , Paralisia das Pregas Vocais/terapia , Prega Vocal
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