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2.
N Engl J Med ; 385(12): 1067-1077, 2021 09 16.
Artigo em Inglês | MEDLINE | ID: mdl-34459569

RESUMO

BACKGROUND: Salt substitutes with reduced sodium levels and increased potassium levels have been shown to lower blood pressure, but their effects on cardiovascular and safety outcomes are uncertain. METHODS: We conducted an open-label, cluster-randomized trial involving persons from 600 villages in rural China. The participants had a history of stroke or were 60 years of age or older and had high blood pressure. The villages were randomly assigned in a 1:1 ratio to the intervention group, in which the participants used a salt substitute (75% sodium chloride and 25% potassium chloride by mass), or to the control group, in which the participants continued to use regular salt (100% sodium chloride). The primary outcome was stroke, the secondary outcomes were major adverse cardiovascular events and death from any cause, and the safety outcome was clinical hyperkalemia. RESULTS: A total of 20,995 persons were enrolled in the trial. The mean age of the participants was 65.4 years, and 49.5% were female, 72.6% had a history of stroke, and 88.4% a history of hypertension. The mean duration of follow-up was 4.74 years. The rate of stroke was lower with the salt substitute than with regular salt (29.14 events vs. 33.65 events per 1000 person-years; rate ratio, 0.86; 95% confidence interval [CI], 0.77 to 0.96; P = 0.006), as were the rates of major cardiovascular events (49.09 events vs. 56.29 events per 1000 person-years; rate ratio, 0.87; 95% CI, 0.80 to 0.94; P<0.001) and death (39.28 events vs. 44.61 events per 1000 person-years; rate ratio, 0.88; 95% CI, 0.82 to 0.95; P<0.001). The rate of serious adverse events attributed to hyperkalemia was not significantly higher with the salt substitute than with regular salt (3.35 events vs. 3.30 events per 1000 person-years; rate ratio, 1.04; 95% CI, 0.80 to 1.37; P = 0.76). CONCLUSIONS: Among persons who had a history of stroke or were 60 years of age or older and had high blood pressure, the rates of stroke, major cardiovascular events, and death from any cause were lower with the salt substitute than with regular salt. (Funded by the National Health and Medical Research Council of Australia; SSaSS ClinicalTrials.gov number, NCT02092090.).


Assuntos
Doenças Cardiovasculares/prevenção & controle , Dieta Hipossódica , Hipertensão/dietoterapia , Acidente Vascular Cerebral/prevenção & controle , Idoso , Doenças Cardiovasculares/epidemiologia , China , Dieta Hipossódica/efeitos adversos , Feminino , Humanos , Hiperpotassemia/complicações , Hipertensão/complicações , Hipertensão/epidemiologia , Masculino , Pessoa de Meia-Idade , Mortalidade , Potássio na Dieta/efeitos adversos , Prevenção Secundária , Acidente Vascular Cerebral/epidemiologia
3.
BMJ Open ; 11(8): e053446, 2021 08 27.
Artigo em Inglês | MEDLINE | ID: mdl-34452971

RESUMO

INTRODUCTION: Heart disease in chronic obstructive pulmonary disease (COPD) is a common but neglected comorbidity. Patients with COPD are frequently excluded from clinical trials of treatments aimed at reducing cardiac morbidity and mortality, which has led to undertreatment of cardiovascular disease in patients with COPD. A particular concern in COPD is the underuse of beta (ß)-blockers. There is observational evidence that cardioselective ß-blockers are safe and may even reduce mortality risk in COPD, although some evidence is conflicting. There is an urgent need to answer the research question: Are cardioselective ß-blockers safe and of benefit in people with moderately severe COPD? The proposed study will investigate whether cardioselective ß-blocker treatment in patients with COPD reduces mortality and cardiac and respiratory morbidity. METHODS AND ANALYSES: This is a double-blind, randomised controlled trial to be conducted in approximately 26 sites in Australia, New Zealand, India, Sri Lanka and other countries as required. Participants with COPD will be randomised to either bisoprolol once daily (range 1.25-5 mg, dependent on tolerated dose) or matched placebo, in addition to receiving usual care for their COPD over the study duration of 24 months.The study will enrol 1164 participants with moderate to severe COPD, aged 40-85 years. Participants will be symptomatic from their COPD and have a postbronchodilator forced expiratory volume in 1 s (FEV1) ≥30% and ≤70% predicted and a history of at least one exacerbation requiring systemic corticosteroids, antibiotics or both in the prior 24 months. ETHICS AND DISSEMINATION: The study protocol has been approved by the Sydney Local Health District Human Research Ethics Committee at The Concord Repatriation General Hospital. TRIAL REGISTRATION NUMBERS: NCT03917914; CTRI/2020/08/027322.


Assuntos
Bisoprolol , Doença Pulmonar Obstrutiva Crônica , Bisoprolol/uso terapêutico , Progressão da Doença , Método Duplo-Cego , Volume Expiratório Forçado , Humanos , Doença Pulmonar Obstrutiva Crônica/complicações , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto
4.
Eur Respir J ; 2021 Aug 24.
Artigo em Inglês | MEDLINE | ID: mdl-34385278

RESUMO

BACKGROUND: Individual case series and cohort studies have reported conflicting results on the vulnerability to and risk of mortality of people with asthma from COVID-19. RESEARCH QUESTION: Are people with asthma at a higher risk of being infected, hospitalised or of poorer clinical outcomes from COVID-19? METHODS: A systematic review and meta-analysis based on five main databases including the WHO COVID-19 database between December 1, 2019 to July 11, 2021 on studies with a control (non-asthma) group was conducted. Prevalence and risk ratios were pooled using Sidik-Jonkman random effects meta-analyses. FINDINGS: Fifty-one studies with an 8.08% (95% CI 6.87-9.30) pooled prevalence of people with asthma among COVID-19 positive cases. The risk ratios were 0.83 (95% CI 0.73-0.95, p=0.01) for acquiring COVID-19; 1.18 (95% CI 0.98-1.42, p=0.08) for hospitalisation; 1.21 (95% CI 0.97-1.51, p=0.09) for ICU admission; 1.06 (95% CI 0.82-1.36, p=0.65) for ventilator use and 0.94 (95% CI 0.76-1.17; p=0.58) for mortality for people with asthma. Subgroup analyses by continent revealed a significant difference in risk of acquiring COVID-19, ICU admission, ventilator use and death between the continents. INTERPRETATION: The risk of being infected with SARS-CoV-2 was reduced compared to the non-asthma group. No statistically significant differences in hospitalisation, ICU admission and ventilator use were found between groups. Subgroup analyses showed significant differences in outcomes from COVID-19 between America, Europe and Asia. Additional studies are required to confirm this risk profile, particularly in Africa and South America where few studies originate.

5.
World J Clin Cases ; 9(23): 6759-6767, 2021 Aug 16.
Artigo em Inglês | MEDLINE | ID: mdl-34447822

RESUMO

BACKGROUND: Acute colonic diverticulitis (ACD) is common in Western countries, with its prevalence increasing throughout the world. As a result of the coronavirus disease 2019 (COVID-19), elective surgery and in-patients' visits have been cancelled or postponed worldwide. AIM: To systematically explore the impact of the pandemic in the management of ACD. METHODS: MEDLINE, Embase, Scopus, MedxRiv, and the Cochrane Library databases were searched to 22 December 2020. Studies which reported on the management of patients with ACD during the COVID-19 pandemic were eligible. For cross sectional studies, outcomes of interest included the number of hospital admission for ACD, as well as key features of disease severity (complicated or not) across two time periods (pre- and during lockdown). RESULTS: A total of 69 papers were inspected, and 21 were eligible for inclusion. Ten papers were cross sectional studies from seven world countries; six were case reports; three were qualitative studies, and two review articles. A 56% overall decrease in admissions for ACD was observed during lockdown, peaking 67% in the largest series. A 4%-8% decrease in the rate of uncomplicated diverticulitis was also noted during the lockdown phase. An initial non-operative management was recommended for complicated diverticulitis, and encouraged to an out-of-hospital regimen. Despite initial concerns on the use of laparoscopy for Hinchey 3 and 4 patients to avoid aerosolized contamination, societal bodies have progressively mitigated their initial recommendations as actual risks are yet to be ascertained. CONCLUSION: During the COVID-19 pandemic, fewer patients presented and were diagnosed with ACD. Such decline may have likely affected the spectrum of uncomplicated disease. Established outpatient management and follow up for selected cases may unburden healthcare resources in time of crisis.

6.
Glob Heart ; 16(1): 47, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34381669

RESUMO

Background: The implications of city lockdown on vital signs during the COVID-19 outbreak are unknown. Objective: We longitudinally tracked vital signs using data from wearable sensors and determined associations with anxiety and depression. Methods: We selected all participants in the HUAWEI Heart Study from Wuhan and four nearby large provincial capital cities (Guangzhou, Chongqing, Hangzhou, Zhengzhou) and extracted all data from 26 December 2019 (one month before city lockdown) to 21 February 2020. Sleep duration and quality, daily steps, oxygen saturation and heart rate were collected on a daily basis. We compared the vital signs before and after the lockdown using segmented regression analysis of the interrupted time series. The depression and anxiety cases were defined as scores ≥8 on the Hospital Anxiety and Depression Scale depression and anxiety subscales [HADS-D and HADS-A] in 727 participants who finished the survey. Results: We included 19,960 participants (mean age 36 yrs, 90% men). Compared with pre-lockdown, resting heart rate dropped immediately by 1.1 bpm after city lockdown (95% confidence interval [CI]: -1.8, -0.4). Sleep duration increased by 0.5 hour (95% CI: 0.3, 0.8) but deep sleep ratio decreased by 0.9% (95% CI: -1.2, -0.6). Daily steps decreased by 3352 steps (95% CI: -4333, -2370). Anxiety and depression existed in 26% and 17% among 727 available participants, respectively, and associated with longer sleep duration (0.2 and 0.1 hour, both p < 0.001). Conclusions: Lockdown of Wuhan in China was associated with an adverse vital signs profile (reduced physical activity, heart rate, and sleep quality, but increased sleep duration). Wearable devices in combination with mobile-based apps may be useful to monitor both physical and mental health. Clinical trial registration: The trial is registered at Chinese Clinical Trial Registry (ChiCTR) website (ChiCTR-OOC-17014138).


Assuntos
COVID-19/epidemiologia , Controle de Doenças Transmissíveis , Exercício Físico , Frequência Cardíaca , Oxigênio/metabolismo , Política Pública , Sono , Adulto , Ansiedade/psicologia , China/epidemiologia , Cidades/epidemiologia , Depressão/psicologia , Feminino , Humanos , Análise de Séries Temporais Interrompida , Masculino , Pessoa de Meia-Idade , Oximetria , Estudos Retrospectivos , SARS-CoV-2 , Sinais Vitais , Dispositivos Eletrônicos Vestíveis , Adulto Jovem
7.
Updates Surg ; 2021 Jul 26.
Artigo em Inglês | MEDLINE | ID: mdl-34312817

RESUMO

Coronavirus disease 2019 (COVID-19) is revolutionizing healthcare delivery. The aim of the study was to reach consensus among experts on the possible applications of telemedicine in colorectal surgery. A group of 48 clinical practice recommendations (CPRs) was developed by a clinical guidance group based on coalescence of evidence and expert opinion. The Telemedicine in Colorectal Surgery Italian Working Group included 54 colorectal surgeons affiliated to the Italian Society of Colo-Rectal Surgery (SICCR) who were involved in the evaluation of the appropriateness of each CPR, based on published RAND/UCLA methodology, in two rounds. Stakeholders' median age was 44.5 (IQR 36-60) years, and 44 (81%) were males. Agreement was obtained on the applicability of telemonitoring and telemedicine for multidisciplinary pre-operative evaluation. The panel voted against the use of telemedicine for a first consultation. 15/48 statements deemed uncertain on round 1 and were re-elaborated and assessed by 51/54 (94%) panelists on round 2. Consensus was achieved in all but one statement concerning the cost of a teleconsultation. There was strong agreement on the usefulness of teleconsultation during follow-up of patients with diverticular disease after an in-person visit. This e-consensus provides the boundaries of telemedicine in colorectal surgery in Italy. Standardization of infrastructures and costs remains to be better elucidated.

8.
Aust Crit Care ; 2021 Jul 26.
Artigo em Inglês | MEDLINE | ID: mdl-34325975

RESUMO

OBJECTIVE: The aim of the study was to determine whether adjunctive hydrocortisone reduced healthcare expenditure and was cost-effective compared with placebo in New Zealand patients in the Adjunctive Glucocorticoid Therapy in Patients with Septic Shock (ADRENAL) trial. DESIGN: This is a health economic analysis using data linkage to New Zealand Ministry of Health databases to determine resource use, costs, and cost-effectiveness for a 24-month period. SETTING: The study was conducted in New Zealand. PARTICIPANTS AND INTERVENTION: Patients with septic shock were randomised to receive a 7-day continuous infusion of 200 mg of hydrocortisone or placebo in the ADRENAL trial. MAIN OUTCOME MEASURES: Healthcare expenditure was associated with all hospital admissions, emergency department presentations, outpatient visits, and pharmacy expenditure. Effectiveness outcomes included mortality at 6 months and 24 months and quality of life at 6 months. Cost-effectiveness outcomes were assessed with reference to quality-adjusted life years gained at 6 months and life years gained at 24 months. RESULTS: Of 3800 patients in the ADRENAL trial, 419 (11.0%) were eligible, and 405 (96.7% of those eligible) were included. The mean total costs per patient over 24 months were $143,627 ± 100,890 and $143,772 ± 97,117 for the hydrocortisone and placebo groups, respectively (p = 0.99). Intensive care unit costs for the index admission were $50,492 and $62,288 per patient for the hydrocortisone and placebo groups, respectively (p = 0.09). The mean number of quality-adjusted life years gained at 6 months and mean number of life years gained at 24 months was not significantly different by treatment group, and the probability of hydrocortisone being cost-effective was 55% at 24 months. CONCLUSIONS: In New Zealand, adjunctive hydrocortisone did not reduce total healthcare expenditure or improve outcomes compared with placebo in patients with septic shock.

9.
Crit Care Explor ; 3(6): e0445, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-34124687

RESUMO

OBJECTIVES: To investigate the association between plasma sodium concentrations and 6-month neurologic outcome in critically ill patients with aneurysmal subarachnoid hemorrhage. DESIGN: Prospective cohort study. SETTING: Eleven ICUs in Australia and New Zealand. PARTICIPANTS: Three-hundred fifty-six aneurysmal subarachnoid hemorrhage patients admitted to ICU between March 2016 and June 2018. The exposure variable was daily measured plasma sodium. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Six-month neurologic outcome as measured by the modified Rankin Scale. A poor outcome was defined as a modified Rankin Scale greater than or equal to 4. The mean age was 57 years (± 12.6 yr), 68% were female, and 32% (n = 113) had a poor outcome. In multivariable analysis, including age, illness severity, and process of care measures as covariates, higher mean sodium concentrations (odds ratio, 1.17; 95% CI, 1.05-1.29), and greater overall variability-as measured by the sd (odds ratio, 1.53; 95% CI, 1.17-1.99)-were associated with a greater likelihood of a poor outcome. Multivariable generalized additive modeling demonstrated, specifically, that a high initial sodium concentration, followed by a gradual decline from day 3 onwards, was also associated with a poor outcome. Finally, greater variability in sodium concentrations was associated with a longer ICU and hospital length of stay: mean ICU length of stay ratio (1.13; 95% CI, 1.07-1.20) and mean hospital length of stay ratio (1.08; 95% CI, 1.01-1.15). CONCLUSIONS: In critically ill aneurysmal subarachnoid hemorrhage patients, higher mean sodium concentrations and greater variability were associated with worse neurologic outcomes at 6 months, despite adjustment for known confounders. Interventional studies would be required to demonstrate a causal relationship.

10.
Eur J Surg Oncol ; 2021 May 14.
Artigo em Inglês | MEDLINE | ID: mdl-34052038

RESUMO

BACKGROUND: Mixed adeno-neuroendocrine carcinomas (MANEC) are a subgroup of mixed neuroendocrine non-neuroendocrine neoplasms (MiNEN) described as mixed neoplasms containing dual neuroendocrine and non-neuroendocrine components. The aim of this study was to appraise the prevalence of MANEC in the lower gastrointestinal (GI) tract and provide reliable estimates of survival. METHOD: A systematic review was undertaken in accordance with PRISMA guidelines using PubMed, Embase, Cochrane Library of Systematic Review, Web of Science, and Scopus databases, and a Bayesian hierarchical survival pooled analysis was performed. RESULTS: Of 182 unique records identified, 71 studies reporting on 752 patients met the inclusion criteria. Mean age was 64.2 ± 13.6, with a male-to-female ratio of 1.25. Overall, 60.3% of MANEC were located in the appendix, 29.3% in the colon, and 10.4% in the anorectum. More than a quarter (29%) of patients had stage IV disease at diagnosis, with higher prevalence in appendiceal than colonic and anorectal primaries. More than 80% had a high-grade (G3) endocrine component. Of the 152 patients followed up for a median of 20 months (interquartile range limits, 16.5-32), median overall survival was 12.3 months (95% credible interval [95%CrI], 11.3-13.7), with a 1.12 [95%CrI, 0.67-1.83] age-adjusted hazard ratio between metastatic and non-metastatic MANEC. Stage IV disease at diagnosis was more prognostically unfavorable in cases of colonic compared to anorectal origin. CONCLUSION: MANEC is a clinically aggressive pathological entity. The results of this study provide new insights for the understanding of tumor location within the lower GI tract and its prognosis in terms of overall survival.

11.
Cochrane Database Syst Rev ; 5: CD012423, 2021 05 31.
Artigo em Inglês | MEDLINE | ID: mdl-34057734

RESUMO

BACKGROUND: Intimate partner violence (IPV) includes any violence (physical, sexual or psychological/emotional) by a current or former partner. This review reflects the current understanding of IPV as a profoundly gendered issue, perpetrated most often by men against women. IPV may result in substantial physical and mental health impacts for survivors. Women affected by IPV are more likely to have contact with healthcare providers (HCPs) (e.g. nurses, doctors, midwives), even though women often do not disclose the violence. Training HCPs on IPV, including how to respond to survivors of IPV, is an important intervention to improve HCPs' knowledge, attitudes and practice, and subsequently the care and health outcomes for IPV survivors. OBJECTIVES: To assess the effectiveness of training programmes that seek to improve HCPs' identification of and response to IPV against women, compared to no intervention, wait-list, placebo or training as usual. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase and seven other databases up to June 2020. We also searched two clinical trials registries and relevant websites. In addition, we contacted primary authors of included studies to ask if they knew of any relevant studies not identified in the search. We evaluated the reference lists of all included studies and systematic reviews for inclusion. We applied no restrictions by search dates or language. SELECTION CRITERIA: All randomised and quasi-randomised controlled trials comparing IPV training or educational programmes for HCPs compared with no training, wait-list, training as usual, placebo, or a sub-component of the intervention. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures outlined by Cochrane. Two review authors independently assessed studies for eligibility, undertook data extraction and assessed risks of bias. Where possible, we synthesised the effects of IPV training in a meta-analysis. Other analyses were synthesised in a narrative manner. We assessed evidence certainty using the GRADE approach. MAIN RESULTS: We included 19 trials involving 1662 participants. Three-quarters of all studies were conducted in the USA, with single studies from Australia, Iran, Mexico, Turkey and the Netherlands. Twelve trials compared IPV training versus no training, and seven trials compared the effects of IPV training to training as usual or a sub-component of the intervention in the comparison group, or both. Study participants included 618 medical staff/students, 460 nurses/students, 348 dentists/students, 161 counsellors or psychologists/students, 70 midwives and 5 social workers. Studies were heterogeneous and varied across training content delivered, pedagogy and time to follow-up (immediately post training to 24 months). The risk of bias assessment highlighted unclear reporting across many areas of bias. The GRADE assessment of the studies found that the certainty of the evidence for the primary outcomes was low to very low, with studies often reporting on perceived or self-reported outcomes rather than actual HCPs' practices or outcomes for women. Eleven of the 19 included studies received some form of research grant funding to complete the research. Within 12 months post-intervention, the evidence suggests that compared to no intervention, wait-list or placebo, IPV training: · may improve HCPs' attitudes towards IPV survivors (standardised mean difference (SMD) 0.71, 95% CI 0.39 to 1.03; 8 studies, 641 participants; low-certainty evidence); · may have a large effect on HCPs' self-perceived readiness to respond to IPV survivors, although the evidence was uncertain (SMD 2.44, 95% CI 1.51 to 3.37; 6 studies, 487 participants; very low-certainty evidence); · may have a large effect on HCPs' knowledge of IPV, although the evidence was uncertain (SMD 6.56, 95% CI 2.49 to 10.63; 3 studies, 239 participants; very low-certainty evidence); · may make little to no difference to HCPs' referral practices of women to support agencies, although this is based on only one study (with 49 clinics) assessed to be very low certainty; · has an uncertain effect on HCPs' response behaviours (based on two studies of very low certainty), with one trial (with 27 participants) reporting that trained HCPs were more likely to successfully provide advice on safety planning during their interactions with standardised patients, and the other study (with 49 clinics) reporting no clear impact on safety planning practices; · may improve identification of IPV at six months post-training (RR 4.54, 95% CI 2.5 to 8.09) as in one study (with 54 participants), although three studies (with 48 participants) reported little to no effects of training on identification or documentation of IPV, or both. No studies assessed the impact of training HCPs on the mental health of women survivors of IPV compared to no intervention, wait-list or placebo. When IPV training was compared to training as usual or a sub-component of the intervention, or both, no clear effects were seen on HCPs' attitudes/beliefs, safety planning, and referral to services or mental health outcomes for women. Inconsistent results were seen for HCPs' readiness to respond (improvements in two out of three studies) and HCPs' IPV knowledge (improved in two out of four studies). One study found that IPV training improved HCPs' validation responses. No adverse IPV-related events were reported in any of the studies identified in this review. AUTHORS' CONCLUSIONS: Overall, IPV training for HCPs may be effective for outcomes that are precursors to behaviour change. There is some, albeit weak evidence that IPV training may improve HCPs' attitudes towards IPV. Training may also improve IPV knowledge and HCPs' self-perceived readiness to respond to those affected by IPV, although we are not certain about this evidence. Although supportive evidence is weak and inconsistent, training may improve HCPs' actual responses, including the use of safety planning, identification and documentation of IPV in women's case histories. The sustained effect of training on these outcomes beyond 12 months is undetermined. Our confidence in these findings is reduced by the substantial level of heterogeneity across studies and the unclear risk of bias around randomisation and blinding of participants, as well as high risk of bias from attrition in many studies. Further research is needed that overcomes these limitations, as well as assesses the impacts of IPV training on HCPs' behavioral outcomes and the well-being of women survivors of IPV.


Assuntos
Pessoal de Saúde/educação , Violência por Parceiro Íntimo , Adulto , Viés , Odontólogos/educação , Feminino , Humanos , Corpo Clínico/educação , Tocologia/educação , Recursos Humanos de Enfermagem/educação , Psicologia/educação , Ensaios Clínicos Controlados Aleatórios como Assunto , Assistentes Sociais/educação , Estudantes de Ciências da Saúde
12.
Am J Kidney Dis ; 2021 May 23.
Artigo em Inglês | MEDLINE | ID: mdl-34029680

RESUMO

RATIONALE & OBJECTIVE: Canagliflozin reduced the risk of kidney failure and related outcomes in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) in the CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) trial. This analysis of CREDENCE trial data examines the effect of canagliflozin on the incidence of kidney-related adverse events (AEs). STUDY DESIGN: A randomized, double-blind, placebo-controlled, multicenter international trial. SETTING & PARTICIPANTS: 4,401 trial participants with T2DM, CKD, and urinary albumin-creatinine ratio >300-5,000 mg/g. INTERVENTIONS: Participants were randomly assigned to receive canagliflozin 100 mg/d or placebo. OUTCOMES: Rates of kidney-related AEs were analyzed using an on-treatment approach, overall and by screening estimated glomerular filtration rate (eGFR) strata (30-<45, 45-<60, and 60-<90 mL/min/1.73 m2). RESULTS: Canagliflozin was associated with a reduction in the overall incidence rate of kidney-related AEs (60.2 vs 84.0 per 1,000 patient-years; hazard ratio [HR], 0.71 [95% CI, 0.61-0.82]; P < 0.001), with consistent results for serious kidney-related AEs (HR, 0.72 [95% CI, 0.51-1.00]; P = 0.05) and acute kidney injury (AKI; HR, 0.85 [95% CI, 0.64-1.13]; P = 0.3). The rates of kidney-related AEs were lower with canagliflozin relative to placebo across the 3 eGFR strata (HRs of 0.73, 0.60, and 0.81 for eGFR 30-<45, 45-<60, and 60-<90 mL/min/1.73 m2, respectively; P = 0.3 for interaction), with similar results for AKI (P = 0.9 for interaction). Full recovery of kidney function within 30 days after an AKI event occurred more frequently with canagliflozin versus placebo (53.1% vs 35.4%; odds ratio, 2.2 [95% CI, 1.0-4.7]; P = 0.04). LIMITATIONS: Kidney-related AEs including AKI were investigator-reported and collected without central adjudication. Biomarkers of AKI and structural tubular damage were not measured, and creatinine data after an AKI event were not available for all participants. CONCLUSIONS: Compared with placebo, canagliflozin was associated with a reduced incidence of serious and nonserious kidney-related AEs in patients with T2DM and CKD. These results highlight the safety of canagliflozin with regard to adverse kidney-related AEs. FUNDING: The CREDENCE trial and this analysis were funded by Janssen Research & Development, LLC, and were conducted as a collaboration between the funder, an academic steering committee, and an academic research organization, George Clinical. TRIAL REGISTRATION: The CREDENCE trial was registered at ClinicalTrials.gov with identifier number NCT02065791.

13.
Dis Colon Rectum ; 64(11): 1385-1397, 2021 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-33833142

RESUMO

BACKGROUND: Barium defecography can assess structural and functional abnormalities in patients with chronic constipation. OBJECTIVE: The purpose of this study was to determine the prevalence of individual and overlapping defecographic findings in this setting. DESIGN: This was a cross-sectional study. SETTINGS: The study was conducted at a university hospital tertiary GI physiology department. PATIENTS: Consecutive examinations of 827 consecutive patients presenting over a 30-month period with well-defined symptom severity (≥12 points on the Cleveland Clinic Constipation score) were included. Systematic evaluation of images with results stratified by sex is described. MAIN OUTCOME MEASURES: Six individual functional or anatomic (intussusception, rectocele, enterocele, megarectum, excessive dynamic perineal descent) defecographic observations were defined a priori, thus permitting 26 possible combinations of findings (ie, 63 abnormal types + 1 normal). RESULTS: Patients with constipation (mean symptom score = 19) were predominantly female (88%), with median age of 49 years (range, 17-98 y) . All 6 individual radiologic findings were identified with a total of 43 combinations found in the cohort; the 14 most prevalent of these accounted for >85% of patients. Only 136 patients (16.4%) had a normal defecography (34.3% males vs 13.9% females; p < 0.0001). Overall, 612 patients (74.0%) had structural (n = 508 (61.4%)) or functional (n=104 (12.6%)) abnormalities in isolation, with 79 (9.6%) others exhibiting combinations of both. Functional abnormalities in isolation were more common in males compared with females (22.5% vs11.2%; p = 0.025) as opposed to structural abnormalities (57.8% vs 85.7%; p < 0.0001). Expulsion time was longer in females compared with males (110 s (60-120 s) vs 90 s (60-120 s); p = 0.049). LIMITATIONS: The study was limited by its lack of multiorgan opacification. CONCLUSIONS: These results provide a contemporary atlas of defecographic findings in constipation. Several individual structural and functional features have been systematically classified, with overlap greater than previously acknowledged and profound differences among sexes that carry implications for tailoring management. See Video Abstract at http://links.lww.com/DCR/B552. CARACTERIZACIN SISTEMTICA DE ANOMALAS DEFECOGRFICAS EN UNA SERIE CONSECUTIVA DE PACIENTES CON ESTREIMIENTO CRNICO: ANTECEDENTES:La defecografía con bario puede evaluar anomalías estructurales y funcionales en pacientes con estreñimiento crónico.OBJETIVO:Determinar la prevalencia de hallazgos defecográficos individuales y superpuestos en este entorno.DISEÑO:Transversal.ENTORNO CLINICO:Hospital Universitario de tercer nivel, departamento de fisiología gastrointestinal.PACIENTES:Exploraciones consecutivas de 827 pacientes consecutivos que se presentaron durante un período de 30 meses con una gravedad de los síntomas bien definida (≥12 puntos en la escala de estreñimiento de la Cleveland Clinic): evaluación sistemática de imágenes con resultados estratificados por sexo.PRINCIPALES MEDIDAS DE VALORACION:Se definieron a priori seis observaciones defecográficas individuales, funcionales o anatómicas (intususcepción, rectocele, enterocele, megarecto, descenso perineal dinámico excesivo), lo que permitió 26 combinaciones posibles de hallazgos (es decir, 63 tipos anormales + 1 normal).RESULTADOS:Los pacientes con estreñimiento (puntuación media de síntomas, 19) eran predominantemente mujeres (88%) con una edad mediana de 49 (17-98) años. Se identificaron 6 hallazgos radiológicos individuales con un total de 43 combinaciones encontradas en la cohorte; los 14 más predominantes de éstos representaron >85% de los pacientes.Solo 136 (16,4%) pacientes tuvieron una defecografía normal (34,3% hombres vs. 13,9% mujeres; P < 0,0001). En general, 612 (74,0%) pacientes tenían anomalías estructurales (n = 508 [61,4%]) o funcionales (n = 104 [12,6%]) de forma aislada, y otros 79 (9,6%) presentaban combinaciones de ambas. Las anomalías funcionales aisladas fueron más comunes en los hombres en comparación con las mujeres (22,5% vs. 11,2%, P = 0,025) en comparación con las anomalías estructurales (57,8 vs. 85,7%, P < 0,0001). El tiempo de expulsión fue mayor en las mujeres en comparación con los hombres (110 [60-120] vs. 90 [60-120] segundos; P = 0,049).LIMITACIONES:Falta de opacificación multiorgánica.CONCLUSIONES:Estos resultados proporcionan un atlas contemporáneo de hallazgos defecográficos en estreñimiento. Varias características individuales, estructurales y funcionales; se han clasificado sistemáticamente, con una superposición mayor que la reconocida anteriormente y con grandes diferencias entre los sexos que tienen implicaciones para adaptar su tratamiento. Consulte Video Resumen en http://links.lww.com/DCR/B552.

14.
Med J Aust ; 214(9): 420-427, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33899216

RESUMO

OBJECTIVES: To determine whether a multifaceted primary health care intervention better controlled cardiovascular disease (CVD) risk factors in patients with high risk of CVD than usual care. DESIGN, SETTING: Parallel arm, cluster randomised trial in 71 Australian general practices, 5 December 2016 - 13 September 2019. PARTICIPANTS: General practices that predominantly used an electronic medical record system compatible with the HealthTracker electronic decision support tool, and willing to implement all components of the INTEGRATE intervention. INTERVENTION: Electronic point-of-care decision support for general practices; combination cardiovascular medications (polypills); and a pharmacy-based medication adherence program. MAIN OUTCOME MEASURES: Proportion of patients with high CVD risk not on an optimal preventive medication regimen at baseline who had achieved both blood pressure and low-density lipoprotein (LDL) cholesterol goals at study end. RESULTS: After a median 15 months' follow-up, primary outcome data were available for 4477 of 7165 patients in the primary outcome cohort (62%). The proportion of patients who achieved both treatment targets was similar in the intervention (423 of 2156; 19.6%) and control groups (466 of 2321; 20.1%; relative risk, 1.06; 95% CI, 0.85-1.32). Further, no statistically significant differences were found for a number of secondary outcomes, including risk factor screening, preventive medication prescribing, and risk factor levels. Use of intervention components was low; it was highest for HealthTracker, used at least once for 347 of 3236 undertreated patients with high CVD risk (10.7%). CONCLUSIONS: Despite evidence for the efficacy of its individual components, the INTEGRATE intervention was not broadly implemented and did not improve CVD risk management in participating Australian general practices. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12616000233426 (prospective).


Assuntos
Doenças Cardiovasculares/terapia , Sistemas de Apoio a Decisões Clínicas/organização & administração , Adesão à Medicação/estatística & dados numéricos , Sistemas Automatizados de Assistência Junto ao Leito/organização & administração , Atenção Primária à Saúde/organização & administração , Adulto , Austrália , Registros Eletrônicos de Saúde/organização & administração , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Melhoria de Qualidade
15.
Diabetes Obes Metab ; 23(8): 1961-1967, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33908683

RESUMO

High protein intake may increase intraglomerular pressure through dilation of the afferent arteriole. Sodium-glucose cotransporter-2 (SGLT2) inhibitors may reduce intraglomerular pressure through activation of tubuloglomerular feedback. Given these opposing effects, we assessed whether the effect of dapagliflozin on glomerular filtration rate (GFR) and urinary albumin-to-creatinine ratio (UACR) was modified by estimated dietary protein intake using data from three separate randomized controlled trials (DELIGHT, IMPROVE and DIAMOND). The median protein intake was 58.4, 63.6 and 90.0 g/d, respectively. In the DELIGHT trial (n = 233), dapagliflozin compared to placebo caused an acute and reversible dip in GFR of 2.1 and 2.2 mL/min/1.73 m2 , and reduced UACR by 20.5% and 28.4% in participants with high and low protein intake, respectively. Similarly, in IMPROVE (n = 30) and DIAMOND (n = 53), the effect of dapagliflozin on GFR and UACR was comparable in participants with high and low protein intake (all P for interaction > 0.40). This post hoc, exploratory analysis of three clinical trials suggests that dietary protein intake does not modify the individual response of clinical kidney variables to dapagliflozin.


Assuntos
Diabetes Mellitus Tipo 2 , Inibidores do Transportador 2 de Sódio-Glicose , Compostos Benzidrílicos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Proteínas na Dieta , Taxa de Filtração Glomerular , Glucose , Hemodinâmica , Humanos , Rim , Ensaios Clínicos Controlados Aleatórios como Assunto , Sódio , Transportador 2 de Glucose-Sódio , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico
16.
J Endovasc Ther ; 28(3): 415-424, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33660577

RESUMO

PURPOSE: Evaluate the impact of hybrid operating room (HOR) guidance on the long-term clinical outcomes following fenestrated and branched endovascular repair (F-BEVAR) for complex aortic aneurysms. MATERIALS AND METHODS: Prospectively collected registry data were retrospectively analyzed to compare the procedural, short- and long-term outcomes of consecutive F-BEVAR performed from January 2010 to December 2014 under standard mobile C-arm versus hybrid room guidance in a high-volume aortic center. RESULTS: A total of 262 consecutive patients, including 133 patients treated with a mobile C-arm equipped operating room and 129 with a HOR guidance, were enrolled in this study. Patient radiation exposure and contrast media volume were significantly reduced in the HOR group. Short-term clinical outcomes were improved despite higher case complexity in the HOR group, with no statistical significance. At a median follow-up of 63.3 months (Q1 33.4, Q3 75.9) in the C-arm group, and 44.9 months (Q1 25.1, Q3 53.5, p=0.53) in the HOR group, there was no statistically significant difference in terms of target vessel occlusion and limb occlusion. When the endograft involved 3 or more fenestrations and/or branches (complex F-BEVAR), graft instability (36% vs 25%, p=0.035), reintervention on target vessels (20% vs 11%, p=0.019) and total reintervention rates (24% vs 15%, p=0.032) were significantly reduced in the HOR group. The multivariable Cox regression analysis did not show statistically significant differences for long-term death and aortic-related death between the 2 groups. CONCLUSION: Our study suggests that better long-term clinical outcomes could be observed when performing complex F-BEVAR in the latest generation HOR.


Assuntos
Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Prótese Vascular , Implante de Prótese Vascular/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Humanos , Salas Cirúrgicas , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento
17.
Surgery ; 170(2): 405-411, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33766426

RESUMO

BACKGROUND: Coronavirus disease 2019 is revolutionizing healthcare delivery. The aim of this study was to reach a consensus among experts as to the possible applications of telemedicine in the proctologic field. METHODS: A group of 55 clinical practice recommendations was developed by a clinical guidance group based on coalescence of evidence and expert opinion. The Telemedicine in Proctology Italian Working Group included 47 Italian Society of Colorectal Surgery nominated experts evaluating the appropriateness of each clinical practice recommendations based on published RAND/UCLA methodology in 2 rounds. RESULTS: Stakeholder median age was 53 years (interquartile range limits 40-60), and 38 (81%) were men. Nine (19%) panelists reported no experience with telemedicine before the pandemic. Agreement was obtained on a minimum of 3 to 5 years of practice in the proctologic field before starting teleconsultations, which should be regularly paid, with advice and prescriptions incorporated into a formal report sent to the patient by e-mail along with a receipt. Of the panelists, 35 of 47 (74%) agreed that teleconsultation carries the risk of misdiagnosis of cancer, thus recommending an in-person assessment before scheduling any surgery. Fifteen additional clinical practice recommendations were re-elaborated in the second round and assessed by 44 of 47 (93.6%) panelists. The application of telemedicine for the diagnosis of common proctologic conditions (eg, hemorrhoidal disease, anal abscess and fistula, anal condylomas, and anal fissure) and functional pelvic floor disorders was generally considered inappropriate. Teleconsultation was instead deemed appropriate for the diagnosis and management of pilonidal disease. CONCLUSION: This e-consensus revealed the boundaries of telemedicine in Italy. Standardization of infrastructures, logistics, and legality remain to be better elucidated.


Assuntos
Cirurgia Colorretal/normas , Telemedicina/normas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
18.
J Asthma ; : 1-14, 2021 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-33556287

RESUMO

OBJECTIVE: As COVID-19 spreads across the world, there are concerns that people with asthma are at a higher risk of acquiring the disease, or of poorer outcomes. This systematic review aimed to summarize evidence on the risk of infection, severe illness and death from COVID-19 in people with asthma. DATA SOURCES AND STUDY SELECTION: A comprehensive search of electronic databases including preprint repositories and WHO COVID-19 database was conducted (until 26 May 2020). Studies reporting COVID-19 in people with asthma were included. For binary outcomes, we performed Sidik-Jonkman random effects meta-analysis. We explored quantitative heterogeneity by subgroup analyses, meta regression and evaluating the I2 statistic. RESULTS: Fifty-seven studies with an overall sample size of 587 280 were included. The prevalence of asthma among those infected with COVID-19 was 7.46% (95% CI = 6.25-8.67). Non-severe asthma was more common than severe asthma (9.61% vs. 4.13%). Pooled analysis showed a 14% risk ratio reduction in acquiring COVID-19 (95% CI = 0.80-0.94; p < 0.0001) and 13% reduction in hospitalization with COVID-19 (95% CI = 0.77-0.99, p = 0.03) for people with asthma compared with those without. There was no significant difference in the combined risk of requiring admission to ICU and/or receiving mechanical ventilation for people with asthma (RR = 0.87 95% CI = 0.94-1.37; p = 0.19) and risk of death from COVID-19 (RR = 0.87; 95% CI = 0.68-1.10; p = 0.25). CONCLUSION: The findings from this study suggest that the prevalence of people with asthma among COVID-19 patients is similar to the global prevalence of asthma. The overall findings suggest that people with asthma have a lower risk than those without asthma for acquiring COVID-19 and have similar clinical outcomes.

19.
Drug Alcohol Depend ; 219: 108459, 2021 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-33401031

RESUMO

BACKGROUND: Experience of childhood maltreatment (CM) is a risk factor for opioid use disorder (OUD). CM is also associated with comorbid mental disorders and poor treatment outcomes among people with OUD. To our knowledge, this is the first systematic review and meta-analysis to estimate the prevalence of CM among people with OUD. METHODS: We searched MEDLINE, EMBASE, and PsycINFO to identify observational studies that evaluated CM among people with OUD from January 1990 to June 2020. Prevalence of each CM type, sample characteristics, and methodological factors were extracted from each eligible study. Random-effects meta-analyses were used to pool prevalence estimates. Stratified meta-analyses were used to assess heterogeneity. RESULTS: Of the 6,438 publications identified, 113 studies reported quantitative CM data among people with OUD and 62 studies (k = 62; N = 21,871) were included in primary analyses. Among people with OUD, the estimated prevalence of sexual abuse was 41% (95% CI 36-47%; k = 38) among women and 16% (95% CI 12-20%; k = 25) among men. Among all people with OUD, prevalence estimates were 38% (95% CI 33-44%; k = 48) for physical abuse, 43% (95% CI 38-49%; k = 31) for emotional abuse, 38% (95% CI 30-46%; k = 17) for physical neglect, and 42% (95% CI 32-51%; k = 17) for emotional neglect. Sex, history of injecting drug use, recruitment methods, and method of assessing CM were associated with substantial heterogeneity. CONCLUSIONS: People with OUD frequently report the experience of CM, supporting the need for trauma-informed interventions among this population. Future research should consider the impact of CM on OUD presentations and when assessment is appropriate, use of validated instruments.


Assuntos
Maus-Tratos Infantis/estatística & dados numéricos , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Adulto , Criança , Maus-Tratos Infantis/psicologia , Feminino , Humanos , Masculino , Prevalência , Fatores de Risco
20.
Pharmacoeconomics ; 39(1): 63-80, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33015754

RESUMO

BACKGROUND: Recently, there has been an increase in use of the stepped wedge trial (SWT) design in the context of health services research, due to its pragmatic and methodological advantages over the parallel group design. OBJECTIVE: Our objective was to summarise the statistical methods used when conducting economic evaluations alongside SWTs. METHODS: A systematic literature search extending to February 2020 was conducted in the PubMed, Scopus, Cochrane and National Health Service Economic Evaluation Database (NHS-EED) databases to find and evaluate studies where there was an intention to conduct an economic evaluation alongside an SWT. Studies were assessed for their eligibility, findings, reporting of statistical methods and quality of reporting. RESULTS: Of the 586 studies retrieved from the literature search, 69 studies were identified and included in this systematic review. A total of 54 studies were published protocols, with eight economic evaluations and seven studies reporting full trial results. Included studies varied in terms of their reporting of statistical methods, in both detail and methodology. There were 34 studies that did not report any statistical methods for the economic evaluation, and only 16 studies reported appropriate methods, mainly using some form of mixed/multilevel model, and two used seemingly unrelated regression. Twelve studies reported the use of generic bootstrap methods and other modelling techniques, whilst the remaining studies failed to appropriately account for clustering, correlation or adjustment for time. CONCLUSIONS: The use of appropriate statistical methods that account for time, clustering and correlation between costs and outcomes is an important part of SWT health economics analysis, one that will benefit from an effort to communicate the methods available and their performance.

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