RESUMEN
BACKGROUND: The Hospitalization or Outpatient Management of Patients With SARS-CoV-2 Infection (HOME-CoV) rule is a checklist of eligibility criteria for home treatment of patients with COVID-19, defined using a Delphi method. RESEARCH QUESTION: Is the HOME-CoV rule reliable for identifying a subgroup of COVID-19 patients with a low risk of adverse outcomes who can be treated at home safely? STUDY DESIGN AND METHODS: We aimed to validate the HOME-CoV rule in a prospective, multicenter study before and after trial of patients with probable or confirmed COVID-19 who sought treatment at the ED of 34 hospitals. The main outcome was an adverse evolution, that is, invasive ventilation or death, occurring within the 7 days after patient admission. The performance of the rule was assessed by the false-negative rate. The impact of the rule implementation was assessed by the absolute differences in the rate of patients who required invasive ventilation or who died and in the rate of patients treated at home, between an observational and an interventional period after implementation of the HOME-CoV rule, with propensity score adjustment. RESULTS: Among 3,000 prospectively enrolled patients, 1,239 (41.3%) demonstrated a negative HOME-CoV rule finding. The false-negative rate of the HOME-CoV rule was 4 in 1,239 (0.32%; 95% CI, 0.13%-0.84%), and its area under the receiver operating characteristic curve was 80.9 (95% CI, 76.5-85.2). On the adjusted populations, 25 of 1,274 patients (1.95%) experienced an adverse evolution during the observational period vs 12 of 1,274 patients (0.95%) during the interventional period: -1.00 (95% CI, -1.86 to -0.15). During the observational period, 858 patients (67.35%) were treated at home vs 871 patients (68.37%) during the interventional period: -1.02 (95% CI, -4.46 to 2.26). INTERPRETATION: A large proportion of patients treated in the ED with probable or confirmed COVID-19 have a negative HOME-CoV rule finding and can be treated safely at home with a very low risk of complications. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT04338841; URL: www.clinicaltrials.gov.
Asunto(s)
Atención Ambulatoria/métodos , COVID-19/terapia , Sistemas de Apoyo a Decisiones Clínicas , Manejo de la Enfermedad , Hospitalización/tendencias , Pacientes Ambulatorios , SARS-CoV-2 , Femenino , Humanos , Masculino , Persona de Mediana Edad , Alta del Paciente/tendenciasRESUMEN
Study Design Secondary analysis of a randomized trial. Background A clinical prediction rule to identify patients with carpal tunnel syndrome (CTS) most likely to respond to manual physical therapy has been published but requires further testing to determine its validity. Objective To assess the validity of a clinical prediction rule proposed for the management of patients with CTS in a different group of patients with a variety of treating clinicians. Methods A preplanned secondary analysis of a randomized controlled trial investigating the efficacy of manual physical therapies, including desensitization maneuvers of the central nervous system, in 120 women suffering from CTS was performed. Patients were randomized to receive 3 sessions of manual physical therapy (n = 60) or surgical release/decompression of the carpal tunnel (n = 60). Self-perceived improvement with a global rating of change was recorded at 6- and 12-month follow-ups. Pain intensity (mean pain and worst pain on a 0-to-10 numeric pain-rating scale) and scores on the Boston Carpal Tunnel Questionnaire (functional status and symptom severity subscales) were assessed at baseline and at 1, 3, 6, and 12 months. A baseline assessment of status on the clinical prediction rule was performed (positive status on the clinical prediction rule was defined as meeting at least 2 of the following criteria: pressure pain threshold of less than 137 kPa over the affected C5-6 joint; heat pain threshold of less than 39.6°C over the affected carpal tunnel; and general health score [Medical Outcomes Study 36-Item Short-Form Health Survey] of greater than 66 points). Linear mixed models with repeated measures were used to examine the validity of the rule. Results Participants with a positive status on the rule who received manual physical therapy did not experience greater improvements compared to those with a negative status on the rule for mean pain (P = .65), worst pain (P = .86), function (P = .99), or symptom severity (P = .85). Further, the clinical prediction rule performed no better than chance in identifying the individuals with CTS most likely to respond to manual physical therapy or surgery (mean pain, P = .87; worst pain, P = .91; function, P = .60; severity, P = .66). No differences in self-perceived improvement were observed at either 6 (P = .68) or 12 (P = .36) months, according to the rule. Conclusion The results of this study did not support the validity of the previously developed clinical prediction rule for manual physical therapy in women with CTS. Level of Evidence Prognosis, level 1b. J Orthop Sports Phys Ther 2016;46(6):443-451. Epub 23 Mar 2016. doi:10.2519/jospt.2016.6348.