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Background: The main objective of this study was to describe the relationship between working conditions, sleep and psycho-affective variables and medical errors., Methods: This was an observational, analytical and cross-sectional study in which 661 medical residents answered questionnaires about working conditions, sleep and psycho-affective variables. Actigraphic sleep parameters and peripheral temperature circadian rhythm were measured in a subgroup of 38 subjects. Bivariate and multivariate predictors of medical errors were assessed., Results: Medical residents reported working 66.2 ± 21.9 weekly hours. The longest continuous shift was of 28.4 ± 10.9 h. They reported sleeping 6.1 ± 1.6 h per day, with a sleep debt of 94 ± 129 min in workdays. A high percentage of them reported symptoms related to psycho-affective disorders. The longest continuous shift duration (OR = 1.03 [95% CI, 1.00-1.05], p = 0.01), working more than six monthly on-call shifts (OR = 1.87 [95% CI, 1.16-3.02], p = 0.01) and sleeping less than six hours per working day (OR = 1.66 [95% CI, 1.10-2.51], p = 0.02) were independently associated with self-reported medical errors. The report of medical errors was associated with an increase in the percentage of diurnal sleep (2.2% [95% CI, 0.1-4.3] vs 14.5% [95% CI, 5.9-23.0]; p = 0.01) in the actigraphic recording., Conclusions: Medical residents have a high working hour load that affect their sleep opportunities, circadian rhythms and psycho-affective health, which are also related to the report of medical errors. These results highlight the importance of implementing multidimensional strategies to improve medical trainees' sleep and wellbeing, increasing in turn their own and patients' safety., (© 2023. The Author(s).)

Objective: To evaluate the performance of clinical criteria (CC) for diagnosis and initiation of empirical treatment with continuous positive airway pressure (CPAP) in patients with suspected obstructive sleep apnea (OSA) compared with the treatment decision based on sleep studies (polysomnography or respiratory polygraphy), guidelines, and experience of participating physicians., Methods: This was a simulated intention-to-treat study in a retrospective (G1) and prospective (G2) cohort. Four observers (two per group) called CC1 and CC2 reviewed the sleep questionnaires and indicated CPAP if the patients presented snoring, frequent apneas (≥ 3-4/week), body mass index (BMI) > 25 kg/m 2 , sleepiness (Epworth > 11), or tiredness (at least 3-4 times per week) and some comorbidity (hypertension, coronary/cerebrovascular event, diabetes). Ten independent observers formed two groups of five (FD1 and FD2) and were blinded to each other's opinion. These observers in FD1 and FD2 decided CPAP treatment based on guidelines of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) or guidelines of the American Academy of Sleep Medicine (AASM) and factored in their own opinion. Sensitivity (S), specificity (Sp), and positive/negative likelihood ratios (LR+/-) were calculated with the test method: CC1/2, and the reference method: majority decision of FD1/2., Results: A total of 653 patients (264 women, 40%) were studied. Median age was 54 years, BMI 28 kg/m 2 , and apnea hypopnea index (AHI) 16.5 events/h. S ranged from 21 to 25% (p 0.60), Sp 96.1 to 97.6% (p 0.39), and LR+ of clinical criteria 6.4 to 8.9 (p 0.52)., Conclusion: CPAP indication without a previous sleep study showed a low sensitivity (≅ 22%) but a specificity greater than 95% in patients with high pretest probability for OSA (snoring, report of frequent apneas, BMI > 25 kg/m 2 and sleepiness or tiredness plus comorbidity).

The CODE questionnaire (COPD detection questionnaire), a simple, binary response scale (yes/no), screening questionnaire, was developed for the identification of patients with chronic obstructive pulmonary disease (COPD). We conducted a survey of 468 subjects with a smoking history in 10 public hospitals in Argentina. Patients with a previous diagnosis of COPD, asthma and other respiratory illness were excluded. Items that measured conceptual domains in terms of characteristics of symptoms, smoking history and demographics data were considered. 96 (20.5%) subjects had a diagnosis of COPD according to the 2010 Global Initiative for Chronic Obstructive Lung Disease strategy document. The variables selected for the final questionnaire were based on univariate and multivariate analyses and clinical criteria. Finally, we selected the presence or absence of six variables (age ≥50 years, smoking history ≥30 pack-years, male sex, chronic cough, chronic phlegm and dyspnoea). Of patients without any of these six variables (0 points), none had COPD. The ability of the CODE questionnaire to discriminate between subjects with and without COPD was good (the area under the receiver operating characteristic curve was 0.75). Higher scores were associated with a greater probability of COPD. The CODE questionnaire is a brief, accurate questionnaire that can identify smoking individuals likely to have COPD., (Copyright ©ERS 2015.)

A Phase I clinical trial was performed on patients with solid tumors refractory to conventional therapy. Crotoxin was administered i.m. for 30 consecutive days at doses ranging from 0.03 to 0.22 mg/m(2). Patients entered the study after providing a written informed consent. Although 26 patients were entered only 23 were evaluated. Reversible, nonlimiting neuromuscular toxicity evidenced as diplopia because of pareses of the external ocular muscles was present in 13 patients. It started at doses of 0.18 mg/m(2) and lasted from 2 to 6 h. These episodes did not require dose adjustment and disappeared in 1-3 weeks of treatment. Three patients experienced palpebral ptosis, nystagmus (grade 2), and anxiety (grade 2-3) at the dose-limiting toxicity of 0.22 mg/m(2). Also at dose-limiting toxicity, 1 patient showed nystagmus (grade 2) and anxiety (grade 3) without evidence of palpebral ptosis. Transient increases (grades 1-3) in the levels of creatinine kinase, aspartate aminotransferase, and alanine transaminase attributed to crotoxin myotoxicity were observed but returned to normal by the last week of treatment. At 0.21 mg/m(2) there was a case of grade-3 anaphylactic reaction on day 31, which required treatment. Hypersensitivity was regarded as an adverse drug-related reaction, and the patient was removed from the protocol. Two patients at different doses (0.12 mg/m(2) and 0.22 mg/m(2)) had sialorrhea. Four patients had asymptomatic transient increase in blood pressure (up to 20 mm Hg) 12 h after the first injection, which lasted 24 h. No treatment was required and toxicity did not reappear. Six patients experienced slight eosinophilia during the first 2 weeks. The maximum tolerated dose was set at 0.21 mg/m(2). Objective measurable partial responses (>50% reduction of tumor mass) were noted in 2 patients treated at 0.21 mg/m(2) and 1 at 0.12 mg/m(2). One patient (at 0.21 mg/m(2)) presented a complete response on day 110. Crotoxin pharmacokinetics showed rapid absorption from the injection site to blood (t(1/2 A) = 5.2 +/- 0.6 min). Plasma concentration reached a peak (C(max) = 0.79 +/- 0.1 ng/ml) at tau(max) = 19 +/- 3 min. The half-life of the distribution (alpha) phase is 22 +/- 2 min. Starting at 1.5 h after injection, the decrease in plasma concentration becomes slower, reaching 14 +/- 3 pg/ml 24 h after injection. The profile is dominated by the elimination (beta) phase with a half-life of 5.2 +/- 0.6 h. Consequently, 24 h after the injection ( approximately 5 half-life) 97% of the product was eliminated. The area under plasma concentration versus time curve was 0.19 +/- 0.05 microg/min/ml. Assuming availability (F) approximately 1, the clearance is C(L) = 26.3 +/- 7 ml/min, and the apparent volume of distribution is V(d) = 12 +/- 3 liter/kg. The recommended dose for a Phase II study is 0.18 mg/m(2).