A more comprehensive evaluation of quality of care after total hip and knee arthroplasty: combining 4 indicators in an ordered composite outcome

Background and purpose — Most arthroplasty registers give hospital-specific feedback on revision rates after total hip and knee arthroplasties (THA/TKA). However, due to the low number of events per hospital, multiple years of data are required to reliably detect worsening performance, and any single indicator provides only part of the quality of care delivered. Therefore, we developed an ordered composite outcome including revision, readmission, complications, and long length-of-stay (LOS) for a more comprehensive view on quality of care and assessed the ability to reliably differentiate between hospitals in their performance (rankability)with fewer years of data. Methods — All THA and TKA performed between 2017 and 2019 in 20 Dutch hospitals were included. All combinations of the 4 indicators were ranked from best to worst to create the ordinal composite outcome for THA and TKA separately. Between-hospital variation for the composite outcome was compared with individual indicators standardized for case-mix differences, and we calculated the statistical rankability using fixed and random effects models. Results — 22,908 THA and 20,423 TKA were included. Between-hospital variation for the THA and TKA composite outcomes was larger when compared with revision, readmission, and complications, and similar to long LOS. Rankabilities for the composite outcomes were above 80% even with 1 year of data, meaning that largely true hospital differences were detected rather than random variation. Interpretation — The ordinal composite outcome gives a more comprehensive overview of quality of delivered care and can reliably differentiate between hospitals in their performance using 1 year of data, thereby allowing earlier introduction of quality improvement initiatives.

Blood Pressure and Cardiovascular Disease in Older Patients With Diabetes: Retrospective Cohort Study

Background Blood pressure (BP) targets in elderly patients with diabetes remain unclear. We evaluated the association between BP and cardiovascular disease in elderly patients with diabetes without cardiovascular disease or heart failure. Methods and Results We performed a retrospective cohort study of 225 563 elderly (aged ≥65 years) patients with diabetes without cardiovascular disease or heart failure from 2009 to 2017 using the National Health Information Database. We divided the participants by systolic BP (SBP) and diastolic BP. Primary composite outcomes were stroke, myocardial infarction, heart failure, and all‐cause death analyzed by Cox proportional hazards regression analysis adjusted for baseline covariates. During a median follow‐up of 7.76 years, the incidence rate of primary composite outcomes was 26.62 per 1000 person‐years. In multivariable Cox proportional hazard modeling, the risk of the primary outcome had a U‐curved association with SBP/diastolic blood pressure with a nadir between 120 and 129 mm Hg/65 and 69 mm Hg, respectively. Hypertension medication was associated with lower risk of primary composite outcomes in SBP ≥140 mm Hg ( P for interaction for SBP <0.001) and diastolic blood pressure ≥90 mm Hg ( P for interaction for diastolic blood pressure=0.018). In participants aged ≥80 years, SBP ≥160 mm Hg was only a marginally higher risk for primary composite outcomes (hazard ratio=1.11; 95% CI, 0.98–1.24). Conclusions In this large sample of older Korean patients with diabetes, cardiovascular events were more common in people with resting SBP or diastolic BP ≥140 or 95 mm Hg, respectively, and also more common in people with resting SBP or diastolic BP <120 or 65 mm Hg, respectively.

Association of aortic valvular complex calcification burden with procedural and long-term clinical outcomes after transcatheter aortic valve replacement

Aims This study aimed to assess the impact of valvular/subvalvular calcium burden on procedural and long-term outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS). Methods and results In this prospective observational cohort study, we included patients with AS undergoing TAVR between March 2010 and December 2019. Calcium burden at baseline was quantified using multidetector computed tomography and the patients were classified into tertile groups according to the amount of calcium. Procedural outcomes [paravalvular leakage (PVL) or permanent pacemaker insertion (PPI)] and 12-month clinical outcomes (composite of death, stroke, or rehospitalization, and all-cause mortality) were assessed. A total of 676 patients (age, 79.8 ± 5.4 years) were analysed. The 30-day rates of moderate or severe PVL (P-for-trend = 0.03) and PPI (P-for-trend = 0.002) proportionally increased with the tertile levels of calcium volume. The 12-month rate of primary composite outcomes was 34.2% in low-tertile, 23.9% in middle-tertile, and 25.8% in high-tertile groups (log-rank P = 0.02). After multivariable adjustment, the risk for primary composite outcomes at 12 months was not significantly different between the tertile groups of calcium volume [reference = low-tertile; middle-tertile, hazard ratio (HR) 0.81; 95% confidence interval (CI) 0.54–1.22; P = 0.31; high-tertile, HR 0.93; 95% CI 0.56–1.57; P = 0.80]. A similar pattern was observed for all-cause mortality. Conclusion The rates of PVL and PPI proportionally increased according to the levels of valvular/subvalvular calcium volume, while the adjusted risks for composite outcomes and mortality at 12 months were not significantly different.

Heterogeneity in design and analysis of ICU delirium randomized trials: a systematic review

Background There is a growing number of randomized controlled trials (RCTs) evaluating interventions to prevent or treat delirium in the intensive care unit (ICU). Efforts to improve the conduct of delirium RCTs are underway, but none address issues related to statistical analysis. The purpose of this review is to evaluate heterogeneity in the design and analysis of delirium outcomes and advance methodological recommendations for delirium RCTs in the ICU. Methods Relevant databases, including PubMed and Embase, were searched with no restrictions on language or publication date; the search was conducted on July 8, 2019. RCTs conducted on adult ICU patients with delirium as the primary outcome were included where trial results were available. Data on frequency and duration of delirium assessments, delirium outcome definitions, and statistical methods were independently extracted in duplicate. The review was registered with PROSPERO (CRD42020141204). Results Among 65 eligible RCTs, 44 (68%) targeted the prevention of delirium. The duration of follow-up varied, with 31 (48%) RCTs having ≤7 days of follow-up, and only 24 (37%) conducting delirium assessments after ICU discharge. The incidence of delirium was the most common outcome (50 RCTs, 77%) for which 8 unique statistical methods were applied. The most common method, applied to 51 of 56 (91%) delirium incidence outcomes, was the two-sample test comparing the proportion of patients who ever experienced delirium. In the presence of censoring of patients at ICU discharge or death, this test may be misleading. The impact of censoring was also not considered in most analyses of the duration of delirium, as evaluated in 24 RCTs, with 21 (88%) delirium duration outcomes analyzed using a non-parametric test or two-sample t test. Composite outcomes (e.g., rank-based delirium- and coma-free days), used in 11 (17%) RCTs, seldom explicitly defined how ICU discharge, and death were incorporated into the definition and were analyzed using non-parametric tests (11 of 13 (85%) composite outcomes). Conclusions To improve delirium RCTs, outcomes should be explicitly defined. To account for censoring due to ICU discharge or death, survival analysis methods should be considered for delirium incidence and duration outcomes; non-parametric tests are recommended for rank-based delirium composite outcomes. Trial registration PROSPERO CRD42020141204. Registration date: 7/3/2019.

Comparison of Pregnancy Outcomes Using Different Gestational Diabetes Diagnostic Criteria and Treatment Thresholds in Multiethnic Communities between Two Tertiary Centres in Australian and New Zealand: Do They Make a Difference?

Introduction: Australia, but not New Zealand (NZ), has adopted the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria to diagnose gestational diabetes (GDM). We compared pregnancy outcomes using these different diagnostic approaches. Method: Prospective data of women with GDM were collected from one NZ (NZ) and one Australian (Aus) hospital between 2007–2018. Aus screening criteria with 2-step risk-based 50 g Glucose Challenge Testing (GCT) followed by 75 g-oral glucose tolerance testing (OGTT): fasting ≥ 5.5, 2-h ≥ 8.0 mmol/L (ADIPS98) changed to a universal OGTT and fasting ≥5.1, 1-h ≥ 10, 2-h ≥ 8.5 mmol/L (IADPSG). NZ used GCT followed by OGTT with fasting ≥ 5.5, 2-h ≥ 9.0 mmol/L (NZSSD); in 2015 adopted a booking HbA1c (NZMOH). Primary outcome was a composite of macrosomia, perinatal death, preterm delivery, neonatal hypoglycaemia, and phototherapy. An Aus subset positive using NZSSD was also defined. RESULTS: The composite outcome odds ratio compared to IADPSG (1788 pregnancies) was higher for NZMOH (934 pregnancies) 2.227 (95%CI: 1.84–2.68), NZSSD (1344 pregnancies) 2.19 (1.83–2.61), and ADIPS98 (3452 pregnancies) 1.91 (1.66–2.20). Composite outcomes were similar between the Aus subset and NZ. Conclusions: The IADPSG diagnostic criteria were associated with the lowest rate of composite outcomes. Earlier NZ screening with HbA1c was not associated with a change in adverse pregnancy outcomes.