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2.
Artigo em Inglês | MEDLINE | ID: mdl-32899534

RESUMO

(1) Objective: The World Health Organization's (WHO) International Classification of Functioning, Disability and Health (ICF) classification is a unified framework for the description of health and health-related states. This study aimed to use the ICF framework to classify outcome measures used in follow-up studies of coronavirus outbreaks and make recommendations for future studies. (2) Methods: EMBASE, MEDLINE, CINAHL and PsycINFO were systematically searched for original studies assessing clinical outcomes in adult survivors of severe acute respiratory distress syndrome (SARS), middle east respiratory syndrome (MERS) and coronavirus disease-19 (COVID-19) after hospital discharge. Individual items of the identified outcome measures were linked to ICF second-level and third-level categories using ICF linking rules and categorized according to an ICF component. (3) Results: In total, 33 outcome measures were identified from 36 studies. Commonly used (a) ICF body function measures were Pulmonary Function Tests (PFT), Impact of event scale (IES-R) and Hospital Anxiety and Depression Scale (HADS); (b) ICF activity was 6-Minute Walking Distance (6MWD); (c) ICF participation measures included Short Form-36 (SF-36) and St George's Respiratory Questionnaire (SGRQ). ICF environmental factors and personal factors were rarely measured. (4) Conclusions: We recommend future COVID-19 follow-up studies to use the ICF framework to select a combination of outcome measures that capture all the components for a better understanding of the impact on survivors and planning interventions to maximize functional return.


Assuntos
Infecções por Coronavirus/diagnóstico , Avaliação de Resultados da Assistência ao Paciente , Pneumonia Viral/diagnóstico , Síndrome Respiratória Aguda Grave/diagnóstico , Atividades Cotidianas , Adulto , Betacoronavirus , Avaliação da Deficiência , Humanos , Classificação Internacional de Funcionalidade, Incapacidade e Saúde , Coronavírus da Síndrome Respiratória do Oriente Médio , Pandemias , Vírus da SARS , Organização Mundial da Saúde
3.
Lancet ; 396(10254): 819-829, 2020 09 19.
Artigo em Inglês | MEDLINE | ID: mdl-32877652

RESUMO

BACKGROUND: Both DAPA-HF (assessing dapagliflozin) and EMPEROR-Reduced (assessing empagliflozin) trials showed that sodium-glucose co-transporter-2 (SGLT2) inhibition reduced the combined risk of cardiovascular death or hospitalisation for heart failure in patients with heart failure with reduced ejection fraction (HFrEF) with or without diabetes. However, neither trial was powered to assess effects on cardiovascular death or all-cause death or to characterise effects in clinically important subgroups. Using study-level published data from DAPA-HF and patient-level data from EMPEROR-Reduced, we aimed to estimate the effect of SGLT2 inhibition on fatal and non-fatal heart failure events and renal outcomes in all randomly assigned patients with HFrEF and in relevant subgroups from DAPA-HF and EMPEROR-Reduced trials. METHODS: We did a prespecified meta-analysis of the two single large-scale trials assessing the effects of SGLT2 inhibitors on cardiovascular outcomes in patients with HFrEF with or without diabetes: DAPA-HF (assessing dapagliflozin) and EMPEROR-Reduced (assessing empagliflozin). The primary endpoint was time to all-cause death. Additionally, we assessed the effects of treatment in prespecified subgroups on the combined risk of cardiovascular death or hospitalisation for heart failure. These subgroups were based on type 2 diabetes status, age, sex, angiotensin receptor neprilysin inhibitor (ARNI) treatment, New York Heart Association (NYHA) functional class, race, history of hospitalisation for heart failure, estimated glomerular filtration rate (eGFR), body-mass index, and region (post-hoc). We used hazard ratios (HRs) derived from Cox proportional hazard models for time-to-first event endpoints and Cochran's Q test for treatment interactions; the analysis of recurrent events was based on rate ratios derived from the Lin-Wei-Yang-Ying model. FINDINGS: Among 8474 patients combined from both trials, the estimated treatment effect was a 13% reduction in all-cause death (pooled HR 0·87, 95% CI 0·77-0·98; p=0·018) and 14% reduction in cardiovascular death (0·86, 0·76-0·98; p=0·027). SGLT2 inhibition was accompanied by a 26% relative reduction in the combined risk of cardiovascular death or first hospitalisation for heart failure (0·74, 0·68-0·82; p<0·0001), and by a 25% decrease in the composite of recurrent hospitalisations for heart failure or cardiovascular death (0·75, 0·68-0·84; p<0·0001). The risk of the composite renal endpoint was also reduced (0·62, 0·43-0·90; p=0·013). All tests for heterogeneity of effect size between trials were not significant. The pooled treatment effects showed consistent benefits for subgroups based on age, sex, diabetes, treatment with an ARNI and baseline eGFR, but suggested treatment-by-subgroup interactions for subgroups based on NYHA functional class and race. INTERPRETATION: The effects of empagliflozin and dapagliflozin on hospitalisations for heart failure were consistent in the two independent trials and suggest that these agents also improve renal outcomes and reduce all-cause and cardiovascular death in patients with HFrEF. FUNDING: Boehringer Ingelheim.


Assuntos
Compostos Benzidrílicos/efeitos adversos , Glucosídeos/efeitos adversos , Insuficiência Cardíaca/tratamento farmacológico , Inibidores do Transportador 2 de Sódio-Glicose/efeitos adversos , Volume Sistólico/efeitos dos fármacos , Idoso , Antagonistas de Receptores de Angiotensina/uso terapêutico , Compostos Benzidrílicos/uso terapêutico , Índice de Massa Corporal , Estudos de Casos e Controles , Causas de Morte/tendências , Ensaios Clínicos como Assunto , Morte , Diabetes Mellitus Tipo 2/complicações , Quimioterapia Combinada , Feminino , Taxa de Filtração Glomerular/efeitos dos fármacos , Taxa de Filtração Glomerular/fisiologia , Glucosídeos/uso terapêutico , Insuficiência Cardíaca/classificação , Insuficiência Cardíaca/fisiopatologia , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Neprilisina/antagonistas & inibidores , Avaliação de Resultados da Assistência ao Paciente , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico
4.
Lancet ; 396(10253): 759-769, 2020 09 12.
Artigo em Inglês | MEDLINE | ID: mdl-32871100

RESUMO

BACKGROUND: Cardiac muscle hypercontractility is a key pathophysiological abnormality in hypertrophic cardiomyopathy, and a major determinant of dynamic left ventricular outflow tract (LVOT) obstruction. Available pharmacological options for hypertrophic cardiomyopathy are inadequate or poorly tolerated and are not disease-specific. We aimed to assess the efficacy and safety of mavacamten, a first-in-class cardiac myosin inhibitor, in symptomatic obstructive hypertrophic cardiomyopathy. METHODS: In this phase 3, randomised, double-blind, placebo-controlled trial (EXPLORER-HCM) in 68 clinical cardiovascular centres in 13 countries, patients with hypertrophic cardiomyopathy with an LVOT gradient of 50 mm Hg or greater and New York Heart Association (NYHA) class II-III symptoms were assigned (1:1) to receive mavacamten (starting at 5 mg) or placebo for 30 weeks. Visits for assessment of patient status occurred every 2-4 weeks. Serial evaluations included echocardiogram, electrocardiogram, and blood collection for laboratory tests and mavacamten plasma concentration. The primary endpoint was a 1·5 mL/kg per min or greater increase in peak oxygen consumption (pVO2) and at least one NYHA class reduction or a 3·0 mL/kg per min or greater pVO2 increase without NYHA class worsening. Secondary endpoints assessed changes in post-exercise LVOT gradient, pVO2, NYHA class, Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS), and Hypertrophic Cardiomyopathy Symptom Questionnaire Shortness-of-Breath subscore (HCMSQ-SoB). This study is registered with ClinicalTrials.gov, NCT03470545. FINDINGS: Between May 30, 2018, and July 12, 2019, 429 adults were assessed for eligibility, of whom 251 (59%) were enrolled and randomly assigned to mavacamten (n=123 [49%]) or placebo (n=128 [51%]). 45 (37%) of 123 patients on mavacamten versus 22 (17%) of 128 on placebo met the primary endpoint (difference +19·4%, 95% CI 8·7 to 30·1; p=0·0005). Patients on mavacamten had greater reductions than those on placebo in post-exercise LVOT gradient (-36 mm Hg, 95% CI -43·2 to -28·1; p<0·0001), greater increase in pVO2 (+1·4 mL/kg per min, 0·6 to 2·1; p=0·0006), and improved symptom scores (KCCQ-CSS +9·1, 5·5 to 12·7; HCMSQ-SoB -1·8, -2·4 to -1·2; p<0·0001). 34% more patients in the mavacamten group improved by at least one NYHA class (80 of 123 patients in the mavacamten group vs 40 of 128 patients in the placebo group; 95% CI 22·2 to 45·4; p<0·0001). Safety and tolerability were similar to placebo. Treatment-emergent adverse events were generally mild. One patient died by sudden death in the placebo group. INTERPRETATION: Treatment with mavacamten improved exercise capacity, LVOT obstruction, NYHA functional class, and health status in patients with obstructive hypertrophic cardiomyopathy. The results of this pivotal trial highlight the benefits of disease-specific treatment for this condition. FUNDING: MyoKardia.


Assuntos
Benzilaminas/uso terapêutico , Miosinas Cardíacas/antagonistas & inibidores , Cardiomiopatia Hipertrófica/tratamento farmacológico , Uracila/análogos & derivados , Antagonistas Adrenérgicos beta/uso terapêutico , Idoso , Benzilaminas/efeitos adversos , Bloqueadores dos Canais de Cálcio/uso terapêutico , Cardiomiopatia Hipertrófica/fisiopatologia , Fármacos Cardiovasculares/uso terapêutico , Método Duplo-Cego , Tolerância ao Exercício/fisiologia , Feminino , Hemodinâmica/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Consumo de Oxigênio/fisiologia , Avaliação de Resultados da Assistência ao Paciente , Uracila/efeitos adversos , Uracila/uso terapêutico
5.
Lancet ; 396(10248): 390-401, 2020 08 08.
Artigo em Inglês | MEDLINE | ID: mdl-32771106

RESUMO

BACKGROUND: Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. The use of immediate surgical fixation to manage this type of fracture has increased, despite insufficient evidence of improved outcomes over non-surgical management. The SWIFFT trial compared the clinical effectiveness of surgical fixation with cast immobilisation and early fixation of fractures that fail to unite in adults with scaphoid waist fractures displaced by 2 mm or less. METHODS: This pragmatic, parallel-group, multicentre, open-label, two-arm, randomised superiority trial included adults (aged 16 years or older) who presented to orthopaedic departments of 31 hospitals in England and Wales with a clear bicortical fracture of the scaphoid waist on radiographs. An independent remote randomisation service used a computer-generated allocation sequence with randomly varying block sizes to randomly assign participants (1:1) to receive either early surgical fixation (surgery group) or below-elbow cast immobilisation followed by immediate fixation if non-union of the fracture was confirmed (cast immobilisation group). Randomisation was stratified by whether or not there was displacement of either a step or a gap of 1-2 mm inclusive on any radiographic view. The primary outcome was the total patient-rated wrist evaluation (PRWE) score at 52 weeks after randomisation, and it was analysed on an available case intention-to-treat basis. This trial is registered with the ISRCTN registry, ISRCTN67901257, and is no longer recruiting, but long-term follow-up is ongoing. FINDINGS: Between July 23, 2013, and July 26, 2016, 439 (42%) of 1047 assessed patients (mean age 33 years; 363 [83%] men) were randomly assigned to the surgery group (n=219) or to the cast immobilisation group (n=220). Of these, 408 (93%) participants were included in the primary analysis (203 participants in the surgery group and 205 participants in the cast immobilisation group). 16 participants in the surgery group and 15 participants in the cast immobilisation group were excluded because of either withdrawal, no response, or no follow-up data at 6, 12, 26, or 52 weeks. There was no significant difference in mean PRWE scores at 52 weeks between the surgery group (adjusted mean 11·9 [95% CI 9·2-14·5]) and the cast immobilisation group (14·0 [11·3 to 16·6]; adjusted mean difference -2·1 [95% CI -5·8 to 1·6], p=0·27). More participants in the surgery group (31 [14%] of 219 participants) had a potentially serious complication from surgery than in the cast immobilisation group (three [1%] of 220 participants), but fewer participants in the surgery group (five [2%]) had cast-related complications than in the cast immobilisation group (40 [18%]). The number of participants who had a medical complication was similar between the two groups (four [2%] in the surgery group and five [2%] in the cast immobilisation group). INTERPRETATION: Adult patients with scaphoid waist fractures displaced by 2 mm or less should have initial cast immobilisation, and any suspected non-unions should be confirmed and immediately fixed with surgery. This treatment strategy will help to avoid the risks of surgery and mostly limit the use of surgery to fixing fractures that fail to unite. FUNDING: National Institute for Health Research Health Technology Assessment Programme.


Assuntos
Moldes Cirúrgicos , Fixação Interna de Fraturas , Fraturas Ósseas/terapia , Osso Escafoide/lesões , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Parafusos Ósseos , Feminino , Fixação de Fratura , Fixação Interna de Fraturas/métodos , Fraturas Ósseas/cirurgia , Fraturas não Consolidadas/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados da Assistência ao Paciente , Osso Escafoide/cirurgia , Tempo para o Tratamento , Adulto Jovem
6.
Plast Reconstr Surg ; 146(3): 339e-350e, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32842117

RESUMO

LEARNING OBJECTIVES: After studying this article, the participant should be able to: 1. Understand the relevant anatomy involved in breast reduction. 2. Understand the different breast reduction techniques and their indications. 3. Appreciate the outcomes of these techniques as they pertain to clinical outcomes. SUMMARY: This continuing medical education article is designed to refresh one's knowledge on breast reduction while placing emphasis on clinical outcomes. It reviews the relevant anatomy, techniques, and published literature on outcomes, including those that are patient-reported. Photographic representations of most techniques are shown, in addition to supplemental digital video content, to demonstrate each technique. This is designed to be an overview, and the reader should appreciate that no one technique is "right," and the technique used should be selected with patient factors and desired outcomes in mind.


Assuntos
Mamoplastia/métodos , Medicina Baseada em Evidências , Feminino , Humanos , Avaliação de Resultados da Assistência ao Paciente , Assistência Perioperatória , Resultado do Tratamento
7.
J Am Acad Orthop Surg ; 28(16): 684-691, 2020 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-32769724

RESUMO

BACKGROUND: Diabetic foot ulcers with associated infection and osteomyelitis often lead to partial or complete limb loss. Determination of the appropriate level for amputation based on the patient's baseline physical function, extent of infection, vascular patency, and comorbidities can be challenging. Although Chopart amputation preserves greater limb length than more proximal alternatives such as Syme or below-the-knee amputations (BKA), challenges with wound healing and prosthesis fitting have been reported. We aimed to investigate the functional and clinical outcomes of Chopart amputation combined with tendon transfers. METHODS: We identified patients who underwent Chopart amputations for diabetic foot infections by an academic orthopaedic group between August 2013 and September 2018. Subjects completed three Patient-Reported Outcomes Measurement Information Systems (PROMIS) instruments. Incidence of postoperative complications and change in patient-reported outcomes before and after surgery were recorded. RESULTS: Eighteen patients with an average age of 60.8 (range, 44 to 79) years were identified. The mean follow-up was 22.8 months (range, 6.7 to 51.0). Seventeen of the 18 total patients developed postoperative wound complications. These lead to revision amputations in 10 Chopart amputees, consisting of two Syme and eight BKAs. Half of the Chopart patients never received a prosthesis because of delayed wound healing and revision amputation. PROMIS physical function (PF) (31.1 pre-op and 28.6 post-op), pain interference (63.1 pre-op and 59.4 post-op), and depression (53.0 pre-op and 54.8 post-op) did not show significant change (P-values = 0.38, 0.29, 0.72, respectively). Pre- and post-op the PROMIS physical function scores were well below the US average. DISCUSSION: In our patient cohort, 94% of patients developed postoperative wound complication. Only 44% of patients ever successfully ambulated with a prosthesis after Chopart amputation, and the others (56%) required revision amputations such as a BKA. Even after wound healing, Chopart amputees may struggle with obtaining a prosthesis suitable for ambulation. Surgeons should exercise judicious patient selection before performing Chopart amputation. LEVEL OF EVIDENCE: IV, Case Series.


Assuntos
Amputação/métodos , Pé Diabético/cirurgia , Adulto , Idoso , Amputação/efeitos adversos , Pé Diabético/complicações , Feminino , Humanos , Infecções/etiologia , Masculino , Pessoa de Meia-Idade , Osteomielite/etiologia , Avaliação de Resultados da Assistência ao Paciente , Seleção de Pacientes , Complicações Pós-Operatórias/epidemiologia , Ajuste de Prótese , Transferência Tendinosa , Resultado do Tratamento , Cicatrização
8.
J Am Acad Orthop Surg ; 28(16): e729-e734, 2020 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-32769725

RESUMO

INTRODUCTION: Patient-reported outcome measures (PROMs) are used to assess performance and value. The type of health insurance coverage may influence outcomes scores. The goal of this study was to determine if the type of insurance coverage is associated with the trends in PROMs within an orthopaedic cohort. METHODS: We reviewed the electronic medical records of 10,745 adult foot and ankle patients who completed PROMs questionnaires from 2015 to 2017. Patients completed the Foot and Ankle Ability Measure, PROMIS Global-Mental, PROMIS Global-Physical, and PROMIS Physical Function Short Form 10a. Descriptive analyses, analysis of variance, and Tukey HSD (honest significant difference) post hoc analyses were conducted. RESULTS: Patients with commercial insurance consistently had the highest outcomes scores, whereas those with Workers Comp/Motor Vehicle and Medicaid had the lowest. PROMs of patients with commercial insurance were statistically significantly higher than the pooled scores of all other patients. Markedly poorer scores were also seen for Workers Comp/Motor Vehicle and Medicaid. In addition, these differences in PROMs for Workers Comp/Motor Vehicle and Medicaid exceeded the minimal clinically important differences. Patients with Medicare or Free Care had generally lower scores than the pooled averages, but these results were not statistically significant. DISCUSSION: PROMs scores vary between the patients with different insurance types in an orthopaedic foot and ankle cohort. These data suggest that patient insurance type may affect patient-reported outcomes. LEVEL OF EVIDENCE: Level III, Retrospective Cohort.


Assuntos
Cobertura do Seguro , Seguro Saúde/classificação , Doenças Musculoesqueléticas/cirurgia , Avaliação de Resultados da Assistência ao Paciente , Adulto , Idoso , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários
9.
PLoS One ; 15(7): e0236948, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32735636

RESUMO

Protein energy wasting (PEW) including muscle atrophy is a common complication in chronic hemodialysis patients. The ubiquitin proteasome system (UPS) is the main proteolytic system causing muscle atrophy in chronic kidney disease and proteasome 20S is the catalytic component of the UPS. Circulating proteasome 20S (c20S proteasome) is present in the blood and its level is related to disease severity and prognosis in several disorders. We hypothesized that c20S proteasome could be related with muscle mass, other PEW criteria and their evolution in hemodialysis patients. Stable hemodialysis patients treated at our center for more than 3 months were followed over 2 years. C20S proteasome assay was performed at baseline. Biological and clinical data were collected, muscle mass was assessed by multi-frequency bio-impedancemetry, and nutritional scores were calculated at baseline, 1 year and 2 years. Hospitalizations and mortality data were collected over the 2 years. Forty-nine patients were included. At baseline, the c20S proteasome level was 0.40[0.26-0.55] µg/ml. Low muscle mass as defined by a lean tissue index (LTI) < 10th in accordance with the International Society of Renal Nutrition and Metabolism guidelines was observed in 36% and PEW in 62%. Increased c20S proteasome levels were related with LTI at baseline (R = 0.43, p = 0.004) and with its 2 year-variation (R = -0.56, p = 0.003). Two-year survival rate was not different between higher and lower c20S proteasome values (78.9 vs 78.4%, p = 0.98 log-rank test). C20S proteasome is not a good marker for assessing nutritional status in hemodialysis patients and predicting patient outcomes.


Assuntos
Biomarcadores/sangue , Complexo de Endopeptidases do Proteassoma/sangue , Desnutrição Proteico-Calórica , Diálise Renal/efeitos adversos , Síndrome de Emaciação , Idoso , Feminino , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Mortalidade , Estado Nutricional , Avaliação de Resultados da Assistência ao Paciente , Complexo de Endopeptidases do Proteassoma/análise , Desnutrição Proteico-Calórica/diagnóstico , Desnutrição Proteico-Calórica/metabolismo , Síndrome de Emaciação/diagnóstico , Síndrome de Emaciação/metabolismo
10.
PLoS One ; 15(7): e0236360, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32706825

RESUMO

In 2011 Yale New Haven Hospital, in response to high utilization of acute care services and widespread patient and health care personnel dissatisfaction, set out to improve its care of adults living with sickle cell disease. Re-organization components included recruitment of additional personnel; re-locating inpatients to a single nursing unit; reducing the number of involved providers; personalized care plans for pain management; setting limits upon access to parenteral opioids; and an emphasis upon clinic visits focused upon home management of pain as well as specialty and primary care. Outcomes included dramatic reductions in inpatient days (79%), emergency department visits (63%), and hospitalizations (53%); an increase in outpatient visits (31%); and a decrease in costs (49%). Providers and nurses viewed the re-organization and outcomes positively. Most patients reported improvements in pain control and life style; many patients thought the re-organization process was unfair. Their primary complaint was a lack of shared decision-making. We attribute the contrast in these perspectives to the inherent difficulties of managing recurrent acute and chronic pain with opioids, especially within the context of the imbalance in wellness, power, and privilege between persons living with sickle cell disease, predominantly persons of color and poor socio-economic status, and health care organizations and their personnel.


Assuntos
Anemia Falciforme/terapia , Hospitais Universitários , Atenção Primária à Saúde/organização & administração , Adulto , Assistência Ambulatorial/estatística & dados numéricos , Analgésicos Opioides/uso terapêutico , Custos e Análise de Custo/estatística & dados numéricos , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Pacientes Internados/estatística & dados numéricos , Masculino , Enfermeiras e Enfermeiros/estatística & dados numéricos , Manejo da Dor/estatística & dados numéricos , Avaliação de Resultados da Assistência ao Paciente , Médicos/estatística & dados numéricos , Fatores Socioeconômicos
12.
Lancet Infect Dis ; 20(8): e192-e197, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32539990

RESUMO

Clinical research is necessary for an effective response to an emerging infectious disease outbreak. However, research efforts are often hastily organised and done using various research tools, with the result that pooling data across studies is challenging. In response to the needs of the rapidly evolving COVID-19 outbreak, the Clinical Characterisation and Management Working Group of the WHO Research and Development Blueprint programme, the International Forum for Acute Care Trialists, and the International Severe Acute Respiratory and Emerging Infections Consortium have developed a minimum set of common outcome measures for studies of COVID-19. This set includes three elements: a measure of viral burden (quantitative PCR or cycle threshold), a measure of patient survival (mortality at hospital discharge or at 60 days), and a measure of patient progression through the health-care system by use of the WHO Clinical Progression Scale, which reflects patient trajectory and resource use over the course of clinical illness. We urge investigators to include these key data elements in ongoing and future studies to expedite the pooling of data during this immediate threat, and to hone a tool for future needs.


Assuntos
Betacoronavirus/isolamento & purificação , Ensaios Clínicos como Assunto/normas , Infecções por Coronavirus/terapia , Avaliação de Resultados em Cuidados de Saúde/normas , Avaliação de Resultados da Assistência ao Paciente , Pneumonia Viral/terapia , Resultado do Tratamento , Humanos , Pandemias , Análise de Sobrevida , Carga Viral
14.
N Engl J Med ; 382(24): 2289-2301, 2020 06 11.
Artigo em Inglês | MEDLINE | ID: mdl-32521132

RESUMO

BACKGROUND: Up-regulation of hepatic delta-aminolevulinic acid synthase 1 (ALAS1), with resultant accumulation of delta-aminolevulinic acid (ALA) and porphobilinogen, is central to the pathogenesis of acute attacks and chronic symptoms in acute hepatic porphyria. Givosiran, an RNA interference therapy, inhibits ALAS1 expression. METHODS: In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned symptomatic patients with acute hepatic porphyria to receive either subcutaneous givosiran (2.5 mg per kilogram of body weight) or placebo monthly for 6 months. The primary end point was the annualized rate of composite porphyria attacks among patients with acute intermittent porphyria, the most common subtype of acute hepatic porphyria. (Composite porphyria attacks resulted in hospitalization, an urgent health care visit, or intravenous administration of hemin at home.) Key secondary end points were levels of ALA and porphobilinogen and the annualized attack rate among patients with acute hepatic porphyria, along with hemin use and daily worst pain scores in patients with acute intermittent porphyria. RESULTS: A total of 94 patients underwent randomization (48 in the givosiran group and 46 in the placebo group). Among the 89 patients with acute intermittent porphyria, the mean annualized attack rate was 3.2 in the givosiran group and 12.5 in the placebo group, representing a 74% lower rate in the givosiran group (P<0.001); the results were similar among the 94 patients with acute hepatic porphyria. Among the patients with acute intermittent porphyria, givosiran led to lower levels of urinary ALA and porphobilinogen, fewer days of hemin use, and better daily scores for pain than placebo. Key adverse events that were observed more frequently in the givosiran group were elevations in serum aminotransferase levels, changes in serum creatinine levels and the estimated glomerular filtration rate, and injection-site reactions. CONCLUSIONS: Among patients with acute intermittent porphyria, those who received givosiran had a significantly lower rate of porphyria attacks and better results for multiple other disease manifestations than those who received placebo. The increased efficacy was accompanied by a higher frequency of hepatic and renal adverse events. (Funded by Alnylam Pharmaceuticals; ENVISION ClinicalTrials.gov number, NCT03338816.).


Assuntos
Acetilgalactosamina/análogos & derivados , Ácido Aminolevulínico/urina , Porfobilinogênio/urina , Porfiria Aguda Intermitente/tratamento farmacológico , Pirrolidinas/uso terapêutico , Terapêutica com RNAi , Acetilgalactosamina/efeitos adversos , Acetilgalactosamina/uso terapêutico , Adulto , Método Duplo-Cego , Fadiga/etiologia , Feminino , Humanos , Injeções Subcutâneas , Análise dos Mínimos Quadrados , Fígado/efeitos dos fármacos , Masculino , Náusea/etiologia , Dor/etiologia , Avaliação de Resultados da Assistência ao Paciente , Porfiria Aguda Intermitente/complicações , Porfiria Aguda Intermitente/urina , Pirrolidinas/efeitos adversos , Insuficiência Renal Crônica/induzido quimicamente , Transaminases/sangue
15.
Medicine (Baltimore) ; 99(23): e20527, 2020 Jun 05.
Artigo em Inglês | MEDLINE | ID: mdl-32502007

RESUMO

BACKGROUND: Shoulder-hand syndrome (SHS) is a common complication in post-stroke patients. SHS has a large impact on patients and their families, communities, healthcare systems and businesses throughout the world. Non-pharmaceutical therapy for post-stroke SHS is the most common treatment in clinical practice, but their effectiveness is still unclear. The aim of this study is to assess the effect and safety of non-pharmaceutical therapeutic strategies for post-stroke SHS. METHOD: We will search 3 in English and 4 in Chinese languages electronic databases regardless of publication date or language. We will include randomized controlled trials (RCTs) assessing the effect of any non-pharmaceutical therapy for post-stroke SHS. Primary outcomes will be any effective instrument for post-stroke SHS. Two authors will independently assess the risk of bias by using Cochrane tool of risk of bias. We will perform network meta-analysis in random effects model to estimate the indirect and mixed effects of different therapeutic strategies by R-3.5.1 software. We will assess the confidence in cumulative evidence by Grading of Recommendations Assessment, Development and Evaluation. RESULTS: This study will be to assess the effect and safety of non-pharmaceutical therapy for post-stroke SHS. CONCLUSIONS: This study will assess the effect of different non-pharmaceutical therapeutic strategies for post-stroke SHS and provide reliable evidence for the choice of treatments.Systematic review registration: PROSPERO (CRD42019139993).


Assuntos
Distrofia Simpática Reflexa/terapia , Acidente Vascular Cerebral/complicações , Terapias Complementares , Humanos , Metanálise em Rede , Avaliação de Resultados da Assistência ao Paciente , Distrofia Simpática Reflexa/etiologia , Projetos de Pesquisa , Revisões Sistemáticas como Assunto
16.
Medicine (Baltimore) ; 99(23): e20544, 2020 Jun 05.
Artigo em Inglês | MEDLINE | ID: mdl-32502016

RESUMO

BACKGROUND: Anterior cruciate ligament (ACL) injury experiences about 200,000 isolated cases annually, and ACL reconstruction has become the gold standard for the restoration of stability and functionality. In view of that incorrect graft placement is a common cause of ACL reconstruction failure, it is critically important to ensure that the tibial and femoral tunnels are properly placed during the operation. Therefore, we intend to conduct a network meta-analysis to comparatively evaluate the clinical outcomes among the different surgical techniques in ACL reconstruction. METHODS: Embase, PubMed, and Cochrane Library will be searched through to retrieve the relevant literature up to April 2020. The outcomes include the International Knee Documentation Committee subjective/objective score, Lachman test, Lysholm score, laxity of knee joint, pivot-shift test, Tegner activity scale, and the number of adverse events. A Bayesian hierarchical framework will be used to evaluate the comparative efficacy among different fixation devices. Cochrane Q test and I statistics will be applied to evaluate the heterogeneity, and the Cochrane risk of bias assessment tool will be employed to evaluate the study quality and the risk of bias. RESULTS: The comparative risk-benefit profiles of different femoral drilling techniques will be evaluated based on the existing evidence, in order to summarize a prioritization regimen. CONCLUSION: Findings from this network meta-analysis will provide useful reference to patients, surgeons, and guideline makers in the related fields. REGISTRATION: Open Science Framework (OSF) Preregistration. April 20, 2020. osf.io/uzahs.


Assuntos
Reconstrução do Ligamento Cruzado Anterior/métodos , Fêmur/cirurgia , Humanos , Metanálise como Assunto , Avaliação de Resultados da Assistência ao Paciente , Projetos de Pesquisa , Medição de Risco , Revisões Sistemáticas como Assunto
17.
Eur Radiol Exp ; 4(1): 39, 2020 06 26.
Artigo em Inglês | MEDLINE | ID: mdl-32592118

RESUMO

BACKGROUND: Computed tomography (CT) enables quantification of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, helping in outcome prediction. METHODS: From 1 to 22 March 2020, patients with pneumonia symptoms, positive lung CT scan, and confirmed SARS-CoV-2 on reverse transcription-polymerase chain reaction (RT-PCR) were consecutively enrolled. Clinical data was collected. Outcome was defined as favourable or adverse (i.e., need for mechanical ventilation or death) and registered over a period of 10 days following CT. Volume of disease (VoD) on CT was calculated semi-automatically. Multiple linear regression was used to predict VoD by clinical/laboratory data. To predict outcome, important features were selected using a priori analysis and subsequently used to train 4 different models. RESULTS: A total of 106 consecutive patients were enrolled (median age 63.5 years, range 26-95 years; 41/106 women, 38.7%). Median duration of symptoms and C-reactive protein (CRP) was 5 days (range 1-30) and 4.94 mg/L (range 0.1-28.3), respectively. Median VoD was 249.5 cm3 (range 9.9-1505) and was predicted by lymphocyte percentage (p = 0.008) and CRP (p < 0.001). Important variables for outcome prediction included CRP (area under the curve [AUC] 0.77), VoD (AUC 0.75), age (AUC 0.72), lymphocyte percentage (AUC 0.70), coronary calcification (AUC 0.68), and presence of comorbidities (AUC 0.66). Support vector machine had the best performance in outcome prediction, yielding an AUC of 0.92. CONCLUSIONS: Measuring the VoD using a simple CT post-processing tool estimates SARS-CoV-2 burden. CT and clinical data together enable accurate prediction of short-term clinical outcome.


Assuntos
Betacoronavirus , Infecções por Coronavirus/diagnóstico , Pulmão/diagnóstico por imagem , Pneumonia Viral/diagnóstico , Reação em Cadeia da Polimerase em Tempo Real/métodos , Tomografia Computadorizada por Raios X/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Infecções por Coronavirus/diagnóstico por imagem , Estudos de Avaliação como Assunto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Avaliação de Resultados da Assistência ao Paciente , Pneumonia Viral/diagnóstico por imagem , Valor Preditivo dos Testes , Prognóstico , Reprodutibilidade dos Testes
18.
Encephale ; 46(3): 169-172, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: covidwho-322038

RESUMO

OBJECTIVES: The ongoing COVID-19 pandemic has caused approximately 2,350,000 infections worldwide and killed more than 160,000 individuals. In Sainte-Anne Hospital (GHU PARIS Psychiatrie & Neuroscience, Paris, France) we have observed a lower incidence of symptomatic forms of COVID-19 among patients than among our clinical staff. This observation led us to hypothesize that psychotropic drugs could have a prophylactic action against SARS-CoV-2 and protect patients from the symptomatic and virulent forms of this infection, since several of these psychotropic drugs have documented antiviral properties. Chlorpromazine (CPZ), a phenothiazine derivative, is also known for its antiviral activity via the inhibition of clathrin-mediated endocytosis. Recentin vitro studies have reported that CPZ exhibits anti-MERS-CoV and anti-SARS-CoV-1 activity. METHODS: In this context, the ReCoVery study aims to repurpose CPZ, a molecule with an excellent tolerance profile and a very high biodistribution in the saliva, lungs and brain. We hypothesize that CPZ could reduce the unfavorable course of COVID-19 infection among patients requiring respiratory support without the need for ICU care, and that it could also reduce the contagiousness of SARS-CoV-2. For this purpose, we plan a pilot, multicenter, randomized, single blind, controlled, phase III therapeutic trial (standard treatment vs. CPZ+standard treatment). CONCLUSION: This repurposing of CPZ for its anti-SARS-CoV-2 activity could offer an alternative, rapid strategy to alleviate infection severity. This repurposing strategy also avoids numerous developmental and experimental steps, and could save precious time to rapidly establish an anti-COVID-19 therapy with well-known, limited and easily managed side effects.


Assuntos
Clorpromazina/uso terapêutico , Infecções por Coronavirus/tratamento farmacológico , Reposicionamento de Medicamentos , Pneumonia Viral/tratamento farmacológico , Antivirais/uso terapêutico , Ansiedade/complicações , Ansiedade/tratamento farmacológico , Ansiedade/epidemiologia , Ansiedade/patologia , Betacoronavirus/patogenicidade , Barreira Hematoencefálica/efeitos dos fármacos , Vesículas Revestidas por Clatrina/efeitos dos fármacos , Infecções por Coronavirus/complicações , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/patologia , Progressão da Doença , Dispneia/tratamento farmacológico , Dispneia/epidemiologia , Dispneia/patologia , Dispneia/psicologia , Endocitose/efeitos dos fármacos , França/epidemiologia , Humanos , Tempo de Internação , Mortalidade , Pandemias , Avaliação de Resultados da Assistência ao Paciente , Projetos Piloto , Pneumonia Viral/complicações , Pneumonia Viral/epidemiologia , Pneumonia Viral/patologia , Recuperação de Função Fisiológica , Método Simples-Cego , Tempo para o Tratamento , Resultado do Tratamento
19.
Med. intensiva (Madr., Ed. impr.) ; 44(4): 216-225, mayo 2020. graf, tab
Artigo em Inglês | IBECS | ID: ibc-190573

RESUMO

OBJECTIVE: The impact of postoperative intensive care upon patient outcomes was evaluated by retrospectively investigating the rate of poor outcomes among miscellaneous elective surgical patients with severe comorbidities. DESIGN: A retrospective cohort study was carried out. SETTING: University hospital. PATIENTS: Surgical patients with severe comorbidities. Intervention: The outcomes of 1218 surgical patients treated in intensive care units (ICUs) and postsurgical wards (ICU group vs. non-ICU group) were reviewed for poor outcomes (i. e. , no discharge or death). A propensity score analysis was used to generate 248 matched pairs of ICU-admitted patients and controls. Variables of interest: Poor outcome rates on postoperative day 90 and mortality on postoperative days 30 and 90. RESULTS: No significant between-group differences were observed in terms of poor outcomes on postoperative day 90 [ICU vs. non-ICU: 33/248 (13%) vs.28/248 (11%), respectively; ICU odds ratio (OR): 1.19, 95% confidence interval (CI), 0.71-2.01, p = 0.596] or in between-group differences in terms of mortality on postoperative days 30 and 90 [ICU vs. non-ICU: 4/248 (1.6%) vs.2/248 (0.8%) on postoperative day 30 and 5/248 (2.0%) vs.3/248 (1.2%) on day 90, respectively; ICU OR (95% CI), 2.00 (0.37-10.9) and 1.67 (0.40-6.97) for postoperative 30- and 90-day mortality, respectively (p = 0.683 and 0.724)]. Low preoperative body weight was negatively correlated to patient outcomes [OR (95% CI): 0.82/10 kg (0.70-0.97), p = 0.019], whereas regional analgesia combined with general anesthesia was positively correlated to patient outcomes [OR (95% CI): 0.39 (0.69-0.96), p = 0.006]. Extra ICU admission was correlated to poor patient outcomes [OR (95% CI): 4.18 (2.23-7.81), p < 0.0001]. CONCLUSIONS: Postoperative ICU admission failed to demonstrate any meaningful benefits in patients with severe comorbidities undergoing miscellaneous elective surgeries


OBJETIVO: Se evaluó el impacto de los cuidados intensivos postoperatorios sobre los desenlaces de los pacientes investigando de forma retrospectiva la tasa de desenlaces desfavorables en un grupo variado de pacientes con comorbilidades graves que se sometieron a cirugías programadas. DISEÑO: Estudio retrospectivo de cohortes. Ámbito: Hospital universitario. PACIENTES: Pacientes quirúrgicos con comorbilidades graves. INTERVENCIONES: Se revisaron los desenlaces de 1.218 pacientes quirúrgicos tratados en unidades de cuidados intensivos (UCI) y plantas posquirúrgicas (grupo UCI frente a grupo no UCI) en busca de desenlaces desfavorables (esto es, ausencia de alta o muerte). Se llevó a cabo un análisis de puntuación de la propensión para generar 248 parejas de pacientes ingresados en la UCI y sus respectivos pacientes de control. Variables de interés: Tasas de desenlaces desfavorables al día 90 tras la intervención y mortalidad a los 30 y 90 días de la intervención. RESULTADOS: No se observaron diferencias significativas entre los grupos en cuanto a desenlaces desfavorables el día 90 tras la intervención (UCI frente a no UCI: 33/248 [13%] frente a 28/248 [11%], respectivamente; oportunidad relativa [OR]: 1,19; intervalo de confianza [IC] del 95%: 0,71-2,01; p = 0,596) ni diferencias entre los grupos en términos de mortalidad al cabo de 30 y 90 días tras la intervención (UCI frente a no UCI: 4/248 [1,6%] frente a 2/248 [0,8%] el día 30 tras la intervención y 5/248 [2,0%] frente a 3/248 [1,2%] el día 90, respectivamente; OR UCI [IC del 95%]: 2,00 [0,37-10,9] y 1,67 [0,40-6,97] para la mortalidad a los 30 y 90 días de la intervención, respectivamente [p = 0,683 y 0,724]). El bajo peso preoperatorio presentó una correlación negativa con los desenlaces de los pacientes (OR [IC del 95%]: 0,82/10 kg [0,70-0,97]; p = 0,019), mientras que la analgesia regional combinada con anestesia general y el ingreso fuera de la UCI presentó una correlación positiva con los desenlaces de los pacientes (OR [IC del 95%]: 0,39 [0,69-0,96]; p = 0,006). El ingreso extra en la UCI se correlacionó con malos resultados para el paciente (OR [IC del 95%]: 4,18 [2,23-7,81], p < 0,0001). CONCLUSIONES: El ingreso posoperatorio en la UCI no demostró asociarse con ningún beneficio significativo en un grupo variado de pacientes con comorbilidades graves sometidos a cirugías programadas


Assuntos
Humanos , Masculino , Feminino , Idoso , Avaliação de Resultados da Assistência ao Paciente , Cuidados Pós-Operatórios/métodos , Comorbidade , Estudos de Coortes , Pontuação de Propensão , Unidades de Terapia Intensiva , Estudos Retrospectivos , Hospitais Universitários
20.
Respir Med ; 168: 105992, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32469708

RESUMO

BACKGROUND: Quality of life (QOL) is an important patient-related outcome (PRO) in patients with cystic fibrosis (CF). There are several QOL questionnaires like the "Cystic Fibrosis Questionnaire Revised" (CFQ-R) or the "St George's Respiratory Questionnaire" (SGRQ) that are well validated in CF. The aim of the study was to evaluate whether the easily applicable "COPD assessment test" (CAT) can be used in CF patients. METHODS: 42 CF patients were recruited within the PulmoHOM study, a prospective, observational cohort study. The CAT, the SGRQ and the CFQ-R were handed out to the patients. The spearman's rank correlation coefficient and the Cronbach's α coefficient were used for the statistical analysis. RESULTS: The internal consistencies of the CAT, SGRQ and the CFQ-R were high (Cronbach's α coefficients = 0.89, 0.91 and 0.83). There were significant correlations between the CAT and the total score of the SGRQ (r = 0.851, p < 0.01), between the CAT and many items of the CFQ-R (physical score of the CFQ-R and total score of the CAT: r = -0.872, p < 0.01) and between the SGRQ and the CFQ-R (physical score of the CFQ-R and total score of the SGRQ: r = -0.878, p < 0.01). CONCLUSION: The main finding was the high correlation between the CAT and the validated questionnaires in CF. The CAT is a PRO instrument that can be filled quickly and that correlates well with the CFQ-R. The CAT or similar tools might be applicable in the care of CF patients.


Assuntos
Fibrose Cística , Avaliação de Resultados da Assistência ao Paciente , Projetos Piloto , Qualidade de Vida , Testes de Função Respiratória/métodos , Adolescente , Adulto , Estudos de Coortes , Feminino , Humanos , Masculino , Estudos Prospectivos , Doença Pulmonar Obstrutiva Crônica , Índice de Gravidade de Doença , Inquéritos e Questionários , Adulto Jovem
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