Validation of the Canadian Institute for Health Information Diagnostic Codes for Benign Gynaecologic Surgery.

We investigated the validity of the 10th Revision Canadian modification of International Statistical Classification of Disease and Related Health Problems (ICD-10-CA) diagnostic codes for surgery for benign gynaecologic conditions in the Canadian Institute for Health Information Discharge Abstract Database (CIHI-DAD), the main source of routinely collected data in Canada. Reabstracted data from patient charts was compared to ICD-10-CA codes and measures of validity were calculated with 95% confidence intervals. A total of 1068 procedures were identified. More objective, structural diagnoses (fibroids, prolapse) had higher sensitivity and near-perfect Kappa coefficients, while more subjective, symptomatic diagnoses (abnormal uterine bleeding, pelvic pain) had lower sensitivity and moderate-substantial Kappa coefficients. Specificity, positive predictive values, and negative predictive values were generally high for all diagnoses. These findings support the use of CIHI-DAD data for gynaecologic research.

A Validation of Hysterectomy Procedural Codes in the Canadian Institute for Health Information Discharge Abstract Database.

OBJECTIVE: The Canadian Institute of Health Information (CIHI) Discharge Abstract Database (DAD) is the main source of routinely collected data for gynaecologic surgery in Canada and is increasingly used for research. These data are prone to error as they were originally collected for administrative purposes, and they therefore should be validated for clinical research. The objective of this study was to validate hysterectomy codes from the DAD at a single institution. METHODS: This was a retrospective observational study using an existing hospital database. We obtained a consecutive sample of all gynaecologic procedures performed at The Ottawa Hospital from April 2016 to March 2017 using the DAD. Patient data, including diagnosis, procedure type, concomitant procedure, and surgical approach, were reabstracted from records. These data were compared with the DAD Canadian Classification of Health Interventions (CCI) codes using sensitivity, specificity, positive predictive value (PPV), and κ coefficient with associated 95% confidence intervals (CIs). RESULTS: Of 1068 gynaecologic procedures, 639 hysterectomies were performed: 39.2% vaginally, 35.4% laparoscopically, and 25.4% abdominally. Median patient age was 46 years (IQR 41-54 y). The κ, sensitivity, specificity, and PPV for all hysterectomies were 0.92 (95% CI 0.90-0.95), 95.1% (95% CI 93.2-96.7), 97.9% (95% CI 96.6-99.3), and 98.5% (95% CI 97.6-99.5), respectively. The κ coefficients for vaginal, laparoscopic, and abdominal hysterectomy were 0.91 (95% CI 0.88-0.94), 0.92 (95% CI 0.89-0.95), and 0.92 (95% CI 0.89-0.95), respectively. Agreement for sub-total hysterectomy and bilateral salpingectomy with oophorectomy was excellent, with κ exceeding 0.80. The level of agreement for salpingectomy alone was poor, though specificity and PPV were high. CONCLUSIONS: Our study suggests that hysterectomy-associated CCI codes in CIHI's DAD have a high level of validity for clinical research purposes.

Exclusion criteria and adverse events in perioperative trials of tranexamic acid in cardiac surgery: a systematic review and meta-analysis.

PURPOSE: Tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement following cardiac surgery. Nevertheless, TXA remains underutilized because of concerns regarding development of adverse events. We conducted a systematic review to determine which patients are commonly excluded from TXA cardiac surgery clinical trials to determine if there are patient groups lacking safety data on TXA. METHODS: The databases Medline, EMBASE, and the Cochrane Central Register of Controlled Trials were searched until September 2017. Eligible studies were randomized-controlled trials (RCTs) administering systemic TXA perioperatively to patients undergoing any cardiac surgery. Our primary outcome was the exclusion criteria for each RCT, and the secondary endpoint was TXA safety. A descriptive synthesis was performed to analyze the exclusion criteria. TXA safety was assessed with meta-analysis. PRINCIPAL FINDINGS: Seventy eligible RCTs were included. The most common reasons for excluding patients from TXA cardiac surgery trials were major hepatic, renal, or cardiac comorbidities (76% of studies). Meta-analysis showed that TXA did not increase the risk of adverse events compared with placebo or no intervention (risk ratio, 0.97; 95% confidence interval, 0.88 to 1.07), including thrombosis and seizure. CONCLUSION: We found that systemic TXA is safe to use in cardiac surgery. Certain patient groups are frequently excluded from TXA cardiac surgery trials, and may consequently have limited efficacy and safety data on TXA. Further research in these patient groups may be needed; nevertheless, for many patient populations there are sufficient data to inform evidence-based guidelines for TXA use in cardiac surgery. TRIAL REGISTRATION: PROSPERO (CRD42017060971); registered 4 April, 2017.

RéSUMé: OBJECTIF: L'acide tranexamique (ATX) réduit les pertes sanguines périopératoires et les besoins transfusionnels après une chirurgie cardiaque. L'ATX demeure toutefois sous-utilisé en raison de craintes quant à la survenue d'événements indésirables. Nous avons réalisé une revue systématique afin d'identifier les patients le plus fréquemment exclus des études cliniques sur l'utilisation d'ATX en chirurgie cardiaque pour déterminer si les données d'innocuité de l'ATX sont insuffisantes pour certains groupes de patients. MéTHODE: Des recherches ont été effectuées dans les bases de données Medline, EMBASE et dans le Cochrane Central Register of Controlled Trials pour en tirer les études publiées jusqu'en septembre 2017. Pour être éligibles, les études devaient être des études randomisées contrôlées (ERC) examinant l'administration systémique d'ATX en période périopératoire à des patients subissant une chirurgie cardiaque, quelle qu'elle soit. Le critère d'évaluation principal de notre étude s'intéressait aux critères d'exclusion de chaque ERC, et le critère d'évaluation secondaire à l'innocuité de l'ATX. Une synthèse descriptive a été réalisée afin d'analyser les critères d'exclusion. L'innocuité de l'ATX a été évaluée par une méta-analyse. CONSTATATIONS PRINCIPALES: Soixante-dix ERC éligibles ont été incluses dans notre revue. Les raisons les plus fréquentes d'exclusion de patients des études d'ATX en chirurgie cardiaque étaient des comorbidités hépatiques, rénales ou cardiaques majeures (76 % des études). La méta-analyse a démontré que l'ATX n'augmentait pas le risque d'événements indésirables par rapport au placebo ou à toute autre intervention (risque relatif, 0,97; intervalle de confiance 95 %, 0,88 à 1,07), y compris le risque de thrombose ou de convulsion. CONCLUSION: Nous avons observé que l'ATX par voie systémique peut être utilisé en toute sécurité en chirurgie cardiaque. Certains groupes de patients sont fréquemment exclus des études portant sur l'ATX en chirurgie cardiaque, et les données sur l'efficacité et l'innocuité de l'ATX dans ces populations pourraient par conséquent être limitées. Des recherches supplémentaires dans ces groupes pourraient être nécessaires; toutefois, les données pour plusieurs populations de patients sont suffisantes pour établir des directives fondées sur les données probantes concernant l'utilisation d'ATX en chirurgie cardiaque. ENREGISTREMENT DE L'éTUDE: PROSPERO (CRD42017060971); enregistrée le 4 avril 2017.

Exclusion criteria and adverse events in perioperative trials of tranexamic acid: a systematic review and meta-analysis.

BACKGROUND: Tranexamic acid (TXA) is an inexpensive therapy effective at minimizing perioperative blood loss and transfusion. However, it remains underutilized due to safety concerns. To date, no evidence-based guidelines exist identifying which patients should not receive TXA therapy. This study determined patient groups for whom safety information regarding TXA is lacking due to common exclusion from perioperative TXA trials. STUDY DESIGN AND METHODS: A systematic review searching the databases Medline, EMBASE, CENTRAL, and Clinicaltrials.gov was performed. Randomized controlled trials (RCTs) administering systemic TXA perioperatively to elective or emergent surgery patients were eligible. Our primary outcome was to describe exclusion criteria of RCTs, and the secondary outcome was TXA safety. A descriptive synthesis of exclusion criteria was performed, and TXA safety was assessed by meta-analysis. RESULTS: A total of 268 eligible RCTs were included. Meta-analysis showed that systemic TXA did not increase risk of adverse events compared to placebo or no intervention (relative risk, 1.05; 95% confidence interval, 0.99-1.12). Patient groups commonly excluded from perioperative TXA trials, and thus potentially lacking TXA safety data, were those with major comorbidities, a history of thromboembolism, medication use affecting coagulation, TXA allergy, and coagulopathy. Exclusion of patients with major comorbidities may not be necessary; we showed that the risk of adverse events was similar in studies that excluded patients with major comorbidities and those that did not. CONCLUSION: Sufficient evidence exists to develop perioperative guidelines for TXA use in many populations. Further studies evaluating perioperative TXA use in patients with a history of thromboembolism are warranted.