Statistical machines for trauma hospital outcomes research: Application to the PRospective, Observational, Multi-center Major trauma Transfusion (PROMMTT) study

Improving the treatment of trauma, a leading cause of death worldwide, is of great clinical and public health interest. This analysis introduces flexible statistical methods for estimating center-level effects on individual outcomes in the context of highly variable patient populations, such as those of the PRospective, Observational, Multi-center Major Trauma Transfusion study. Ten US level I trauma centers enrolled a total of 1,245 trauma patients who survived at least 30 minutes after admission and received at least one unit of red blood cells. Outcomes included death, multiple organ failure, substantial bleeding, and transfusion of blood products. The centers involved were classified as either large or small-volume based on the number of massive transfusion patients enrolled during the study period. We focused on estimation of parameters inspired by causal inference, specifically estimated impacts on patient outcomes related to the volume of the trauma hospital that treated them. We defined this association as the change in mean outcomes of interest that would be observed if, contrary to fact, subjects from large-volume sites were treated at small-volume sites (the effect of treatment among the treated). We estimated this parameter using three different methods, some of which use data-adaptive machine learning tools to derive the outcome models, minimizing residual confounding by reducing model misspecification. Differences between unadjusted and adjusted estimators sometimes differed dramatically, demonstrating the need to account for differences in patient characteristics in clinic comparisons. In addition, the estimators based on robust adjustment methods showed potential impacts of hospital volume. For instance, we estimated a survival benefit for patients who were treated at large-volume sites, which was not apparent in simpler, unadjusted comparisons. By removing arbitrary modeling decisions from the estimation process and concentrating on parameters that have more direct policy implications, these potentially automated approaches allow methodological standardization across similar comparativeness effectiveness studies

Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study

Background: The impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on postoperative recovery needs to be understood to inform clinical decision making during and after the COVID-19 pandemic. This study reports 30-day mortality and pulmonary complication rates in patients with perioperative SARS-CoV-2 infection. Methods: This international, multicentre, cohort study at 235 hospitals in 24 countries included all patients undergoing surgery who had SARS-CoV-2 infection confirmed within 7 days before or 30 days after surgery. The primary outcome measure was 30-day postoperative mortality and was assessed in all enrolled patients. The main secondary outcome measure was pulmonary complications, defined as pneumonia, acute respiratory distress syndrome, or unexpected postoperative ventilation. Findings: This analysis includes 1128 patients who had surgery between Jan 1 and March 31, 2020, of whom 835 (74·0%) had emergency surgery and 280 (24·8%) had elective surgery. SARS-CoV-2 infection was confirmed preoperatively in 294 (26·1%) patients. 30-day mortality was 23·8% (268 of 1128). Pulmonary complications occurred in 577 (51·2%) of 1128 patients; 30-day mortality in these patients was 38·0% (219 of 577), accounting for 81·7% (219 of 268) of all deaths. In adjusted analyses, 30-day mortality was associated with male sex (odds ratio 1·75 [95% CI 1·28–2·40], p\textless0·0001), age 70 years or older versus younger than 70 years (2·30 [1·65–3·22], p\textless0·0001), American Society of Anesthesiologists grades 3–5 versus grades 1–2 (2·35 [1·57–3·53], p\textless0·0001), malignant versus benign or obstetric diagnosis (1·55 [1·01–2·39], p=0·046), emergency versus elective surgery (1·67 [1·06–2·63], p=0·026), and major versus minor surgery (1·52 [1·01–2·31], p=0·047). Interpretation: Postoperative pulmonary complications occur in half of patients with perioperative SARS-CoV-2 infection and are associated with high mortality. Thresholds for surgery during the COVID-19 pandemic should be higher than during normal practice, particularly in men aged 70 years and older. Consideration should be given for postponing non-urgent procedures and promoting non-operative treatment to delay or avoid the need for surgery. Funding: National Institute for Health Research (NIHR), Association of Coloproctology of Great Britain and Ireland, Bowel and Cancer Research, Bowel Disease Research Foundation, Association of Upper Gastrointestinal Surgeons, British Association of Surgical Oncology, British Gynaecological Cancer Society, European Society of Coloproctology, NIHR Academy, Sarcoma UK, Vascular Society for Great Britain and Ireland, and Yorkshire Cancer Research

Early abnormal fibrinolysis and mortality in patients with thermal injury: a prospective cohort study

Abnormal fibrinolysis early after injury has been associated with increased mortality in trauma patients, but no studies have addressed patients with burn injury. This prospective cohort study aimed to characterize fibrinolytic phenotypes in burn patients and to see if they were associated with mortality. Patients presenting to a regional burn centre within 4 h of thermal injury were included. Blood was collected for sequential viscoelastic measurements using thromboelastography (RapidTEG™) over 12 h. The percentage decrease in clot strength 30 min after the time of maximal clot strength (LY30) was used to categorize patients into hypofibrinolytic/fibrinolytic shutdown (SD), physiological (PHYS) and hyperfibrinolytic (HF) phenotypes. Injury characteristics, demographics and outcomes were compared. Of 115 included patients, just over two thirds were male. Overall median age was 40 (i.q.r. 28-57) years and median total body surface area (TBSA) burn was 13 (i.q.r. 6-30) per cent. Some 42 (36.5 per cent) patients had severe burns affecting over 20 per cent TBSA. Overall mortality was 18.3 per cent. At admission 60.0 per cent were PHYS, 30.4 per cent were SD and 9.6 per cent HF. HF was associated with increased risk of mortality on admission (odds ratio 12.61 (95 per cent c.i. 1.12 to 142.57); P = 0.041) but not later during the admission when its incidence also decreased. Admission SD was not associated with mortality, but incidence increased and by 4 h and beyond, SD was associated with increased mortality, compared with PHYS (odds ratio 8.27 (95 per cent c.i. 1.16 to 58.95); P = 0.034). Early abnormal fibrinolytic function is associated with mortality in burn patients

O papel da biópsia intraoperatória de congelação para os nódulos tireoidianos The role of intraoperative frozen sections for thyroid nodules

O valor da biópsia de congelação (BC) durante a tireoidectomia é controverso. OBJETIVO: Avaliar o papel da BC na conduta frente os nódulos tireoidianos. CASUÍSTICA E MÉTODO: Trabalho prospectivo de pacientes submetidos à cirurgia tireoidiana por doença nodular e com PAAF guiada por USG prévia em 2006. A BC intra-operatória foi classificada em benigna, maligna ou neoplasia folicular. PAAF, BC e exame de "parafina" foram comparados. RESULTADOS: À BC, 54% dos nódulos eram benignos, 30% neoplasia foliculares e 16% malignos. Todos os casos considerados benignos e malignos pela BC foram confirmados pelo exame de "parafina". Classificando as neoplásicas foliculares como "benignas" à BC, pois não possuem critério para indicação de tireoidectomia total, sensibilidade, especificidade, valores preditivos para os testes positivo e negativo e acurácia global foram, respectivamente, 69%, 100%, 100%, 91,5% e 77%. Casos classificados como "benignos" e "malignos" à PAAF foram confirmados pela BC e "parafina." Dentre os 42 casos de "neoplasia folicular" à PAAF, em um caso, a BC concluiu como carcinoma papilífero, em três, como benigno (confirmados pela "parafina"); e, em 38, manteve "padrão folicular", sendo 29 adenomas foliculares e nove carcinomas à "parafina". CONCLUSÕES: A BC somente está indicada nos casos cuja PAAF seja "neoplasia folicular."<br>The role of intraoperative frozen sections (FS) during thyroidectomy is controversial. AIM: to evaluate the role of FS for thyroid nodules management. PATIENTS AND METHODS: All patients who had thyroid surgery for nodular disease and previous USG-guided FNAB in 2006 were prospectively analyzed. They underwent intraoperative FS evaluation, and the biopsy material was classified as benign, malignant or follicular neoplasm. FNAB, FS and paraffin sections were compared. RESULTS: Under the FS, 54% of the nodules were benign, 30% were follicular neoplasms, and 16% were malignant. All cases considered benign and malignant under the FS evaluation were confirmed through the histological "paraffin" analysis. Since it is not considered a definitive indication for total thyroidectomy, if the follicular neoplasms were classified as "benign" under the FS, their sensitivity, specificity, positive and negative predictive values and global diagnostic accuracy were 69%, 100%, 100%, 91,5% e 77%, respectively. Among the 42 cases classified as "follicular neoplasm" under the FNAB, in 1 case the FS conclusion was for papillary carcinoma, in 3 cases as benign (all confirmed through the "paraffin"); and 38 cases continued as "follicular pattern", being 29 follicular adenomas and 9 carcinomas through the "paraffin". CONCLUSION: The FS is only indicated when the FNAB reports "follicular neoplasm"