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ObjectiveTo identify existing prognostic delirium prediction models and evaluate their validity and statistical methodology in the older adult (≥60 years) acute hospital population.DesignSystematic review.Data sources and methodsPubMed, CINAHL, PsychINFO, SocINFO, Cochrane, Web of Science and Embase were searched from 1 January 1990 to 31 December 2016. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses and CHARMS Statement guided protocol development. Inclusion criteria: age >60 years, inpatient, developed/validated a prognostic delirium prediction model. Exclusion criteria: alcohol-related delirium, sample size ≤50. The primary performance measures were calibration and discrimination statistics. Two authors independently conducted search and extracted data. The synthesis of data was done by the first author. Disagreement was resolved by the mentoring author.ResultsThe initial search resulted in 7,502 studies. Following full-text review of 192 studies, 33 were excluded based on age criteria (<60 years) and 27 met the defined criteria. Twenty-three delirium prediction models were identified, 14 were externally validated and 3 were internally validated. The following populations were represented: 11 medical, 3 medical/surgical and 13 surgical. The assessment of delirium was often non-systematic, resulting in varied incidence. Fourteen models were externally validated with an area under the receiver operating curve range from 0.52 to 0.94. Limitations in design, data collection methods and model metric reporting statistics were identified.ConclusionsDelirium prediction models for older adults show variable and typically inadequate predictive capabilities. Our review highlights the need for development of robust models to predict delirium in older inpatients. We provide recommendations for the development of such models.

ABSTRACTBackgroundUse of poton pump inhibitors (PPIs) is associated with increased risk of Clostridioides difficile–associated colitis, pneumonia, and acute kidney injury. Their effect on postoperative complications is unknown. The objective of this study was to investigate the association between PPIs and the risk of C. difficile–associated colitis, pneumonia, and acute kidney injury following elective surgery. MethodsIn this population-based, matched cohort study, we identified patients who had filled a PPI prescription within 90 days before major elective surgery (2010–2019). Study outcomes included C. difficile–associated colitis, pneumonia, acute kidney injury, gastrointestinal bleeding, and death within 90 days of surgery. We matched patients 1-to-1 on the basis of age, sex, procedure, date of surgery, and a propensity score predicting PPI exposure. We used logistic regression to evaluate between-group differences. ResultsOf 313 163 patients, 89 047 (28.4%) used PPIs; of those, 79 681 were successfully matched to patients who did not use PPIs. The risk of the composite outcome (acute kidney injury, pneumonia, C. difficile–associated colitis, and death) among the patients who used PPIs was slightly higher than among the patients who did not use PPIs (10.6% v. 10.2 4%), and was driven primarily by a higher rate of pneumonia among those who used PPIs (4.0% v. 3.7%). There was a lower rate of gastrointestinal bleeding among the patients who used PPIs (1.6% v. 1.8%). The risk of pneumonia was most pronounced in the subgroup undergoing hip and knee replacement (odds ratio 1.21, 95% confidence interval 1.08–1.36; p = 0.001). There were no significant differences between groups with regard to rates of C. difficile–associated colitis or acute kidney injury. ConclusionWe found that preoperative PPI use was associated with higher rates of pneumonia, particularly among patients undergoing hip and knee replacement surgery, and lower rates of gastrointestinal bleeding. Patients taking a PPI before surgery should be targeted for therapies aimed at reducing pneumonia risk, such as aggressive chest physiotherapy, following their operation.

BackgroundThe COVID-19 pandemic limited access to primary care and in-person assessments requiring healthcare providers to re-envision care delivery for acutely unwell outpatients. Design thinking methodology has the potential to support the robust evolution of a new clinical model.AimTo demonstrate how design thinking methodology can rapidly and rigorously create and evolve a safe, timely, equitable and patient-centred programme of care, and to share valuable lessons for effective implementation of design thinking solutions to address complex problems.MethodWe describe how design thinking methodology was employed to create a new clinical model of care. Using the example of a novel telemedicine programme to support acutely unwell, community-dwelling COVID-19-positive patients called the London Urgent COVID-19 Care Clinic (LUC3), we show how continuous quality outcomes (safety, timeliness, equity and patient-centredness), as well as patient experience survey responses, can drive iterative changes in programme delivery.ResultsThe inspiration phase identified four key needs for this patient population: monitoring COVID-19 signs and symptoms; self-managing COVID-19 symptoms; managing other comorbidities in the setting of COVID-19; and escalating care as needed. Guided by these needs, a cross-disciplinary stakeholder group was engaged in the ideation and implementation phases to create a unique and comprehensive telemedicine programme (LUC3). During the implementation phase, LUC3 assessed 2202 community-based patients diagnosed with acute COVID-19; the collected quality outcomes and end-user feedback led to evolution of programme delivery.ConclusionDesign thinking methodology provided an essential framework and valuable lessons for the development of a safe, equitable, timely and patient-centred telemedicine care programme. The lessons learnt here—the importance of inclusive collaboration, using empathy to guide equity-focused interventions, leveraging continuous metrics to drive iteration and aiming for good-if-not-perfect plans—can serve as a road map for using design thinking for targeted healthcare problems.

Objective To synthesise the association of shift work with major vascular events as reported in the literature.Data sources Systematic searches of major bibliographic databases, contact with experts in the field, and review of reference lists of primary articles, review papers, and guidelines.Study selection Observational studies that reported risk ratios for vascular morbidity, vascular mortality, or all cause mortality in relation to shift work were included; control groups could be non-shift (“day”) workers or the general population.Data extraction Study quality was assessed with the Downs and Black scale for observational studies. The three primary outcomes were myocardial infarction, ischaemic stroke, and any coronary event. Heterogeneity was measured with the I2 statistic and computed random effects models.Results 34 studies in 2 011 935 people were identified. Shift work was associated with myocardial infarction (risk ratio 1.23, 95% confidence interval 1.15 to 1.31; I2=0) and ischaemic stroke (1.05, 1.01 to 1.09; I2=0). Coronary events were also increased (risk ratio 1.24, 1.10 to 1.39), albeit with significant heterogeneity across studies (I2=85%). Pooled risk ratios were significant for both unadjusted analyses and analyses adjusted for risk factors. All shift work schedules with the exception of evening shifts were associated with a statistically higher risk of coronary events. Shift work was not associated with increased rates of mortality (whether vascular cause specific or overall). Presence or absence of adjustment for smoking and socioeconomic status was not a source of heterogeneity in the primary studies. 6598 myocardial infarctions, 17 359 coronary events, and 1854 ischaemic strokes occurred. On the basis of the Canadian prevalence of shift work of 32.8%, the population attributable risks related to shift work were 7.0% for myocardial infarction, 7.3% for all coronary events, and 1.6% for ischaemic stroke.Conclusions Shift work is associated with vascular events, which may have implications for public policy and occupational medicine.

A P-value <0.05 is one metric used to evaluate the results of a randomized controlled trial (RCT). We wondered how often statistically significant results in RCTs may be lost with small changes in the numbers of outcomes. A review of RCTs in high-impact medical journals that reported a statistically significant result for at least one dichotomous or time-to-event outcome in the abstract. In the group with the smallest number of events, we changed the status of patients without an event to an event until the P-value exceeded 0.05. We labeled this number the Fragility Index; smaller numbers indicated a more fragile result. The 399 eligible trials had a median sample size of 682 patients (range: 15–112,604) and a median of 112 events (range: 8–5,142); 53% reported a P-value <0.01. The median Fragility Index was 8 (range: 0–109); 25% had a Fragility Index of 3 or less. In 53% of trials, the Fragility Index was less than the number of patients lost to follow-up. The statistically significant results of many RCTs hinge on small numbers of events. The Fragility Index complements the P-value and helps identify less robust results.

Background Surgical bleeding is associated with postoperative cardiovascular complications. The efficacy and safety of tranexamic acid (TXA) in noncardiac surgery are still uncertain. Statins may prevent perioperative cardiovascular complications. We conducted a pilot to assess the feasibility of a perioperative trial of TXA and rosuvastatin. Methods Using a factorial design, we randomized patients at cardiovascular risk undergoing noncardiac surgery to intravenous TXA (1 g at the start and end of surgery) or placebo, and oral rosuvastatin (40 mg before and 20 mg daily for 30 days after surgery) or placebo. Feasibility outcomes included recruitment rates, follow-up, and compliance to interventions. Clinical outcomes were secondarily explored. Results After 3 months, we changed the design to a partial factorial due to the difficult recruitment of statin-naive patients. Over 6 months, 100 patients were randomized in the TXA trial (49 TXA, 51 placebo), 34 in the rosuvastatin trial (18 rosuvastatin, 16 placebo). Ninety-two percent (95% CI 80–98) of TXA and 86% (95% CI 74–94) of TXA-placebo patients received the 2 study doses. Thirty-three percent (95% CI 13–59) of rosuvastatin patients and 37% (95% CI 15–65) of rosuvastatin-placebo patients discontinued the study drug. A major cardiovascular complication occurred at 30 days in 1 TXA and 6 TXA-placebo patients, and 1 rosuvastatin and no rosuvastatin-placebo patients. Conclusions Our pilot study supports the feasibility of a perioperative TXA trial in noncardiac surgery. Feasibility of a perioperative rosuvastatin trial is uncertain because of a high prevalence of statin use in the target population and concerns about compliance. Trial registration ClinicalTrials.gov NCT02546648 .

BackgroundThe quality and safety movement has reinvigorated interest in optimising morbidity and mortality (M&M) rounds. We performed a systematic review to identify effective means of updating M&M rounds to (1) identify and address quality and safety issues, and (2) address contemporary educational goals.MethodsRelevant databases (Medline, Embase, PubMed, Education Resource Information Centre, Cumulative Index to Nursing and Allied Health Literature, Healthstar, and Global Health) were searched to identify primary sources. Studies were included if they (1) investigated an intervention applied to M&M rounds, (2) reported outcomes relevant to the identification of quality and safety issues, or educational outcomes relevant to quality improvement (QI), patient safety or general medical education and (3) included a control group. Study quality was assessed using the Medical Education Research Study Quality Instrument and Newcastle-Ottawa Scale-Education instruments. Given the heterogeneity of interventions and outcome measures, results were analysed thematically.ResultsThe final analysis included 19 studies. We identified multiple effective strategies (updating objectives, standardising elements of rounds and attaching rounds to a formal quality committee) to optimise M&M rounds for a QI/safety purpose. These efforts were associated with successful integration of quality and safety content into rounds, and increased implementation of QI interventions. Consistent effects on educational outcomes were difficult to identify, likely due to the use of methodologies ill-fitted for educational research.ConclusionsThese results are encouraging for those seeking to optimise the quality and safety mission of M&M rounds. However, the inability to identify consistent educational effects suggests the investigation of M&M rounds could benefit from additional methodologies (qualitative, mixed methods) in order to understand the complex mechanisms driving learning at M&M rounds.

Objectives To determine if coronary computed tomographic angiography enhances prediction of perioperative risk in patients before non-cardiac surgery and to assess the preoperative coronary anatomy in patients who experience a myocardial infarction after non-cardiac surgery.Design Prospective cohort study.Setting 12 centers in eight countries.Participants 955 patients with, or at risk of, atherosclerotic disease who underwent non-cardiac surgery.Interventions Coronary computed tomographic angiography was performed preoperatively; clinicians were blinded to the results unless left main disease was suspected. Results were classified as normal, non-obstructive (<50% stenosis), obstructive (one or two vessels with ≥50% stenosis), or extensive obstructive (≥50% stenosis in two vessels including the proximal left anterior descending artery, three vessels, or left main).Main outcome measure Composite of cardiovascular death and non-fatal myocardial infarction within 30 days after surgery (primary outcome). This was the dependent variable in Cox regression. The independent variables were scores on the revised cardiac risk index and findings on coronary computed tomographic angiography.Results The primary outcome occurred in 74 patients (8%). The model that included both scores on the revised cardiac risk index and findings on coronary computed tomographic angiography showed that coronary computed tomographic angiography provided independent prognostic information (P=0.014; C index=0.66). The adjusted hazard ratios were 1.51 (95% confidence interval 0.45 to 5.10) for non-obstructive disease; 2.05 (0.62 to 6.74) for obstructive disease; and 3.76 (1.12 to 12.62) for extensive obstructive disease. For the model with coronary computed tomographic angiography compared with the model based on the revised cardiac risk index alone, with 30 day risk categories of <5%, 5-15%, and >15% for the primary outcome, the results of risk reclassification indicate that in a sample of 1000 patients that coronary computed tomographic angiography would have resulted appropriately in 17 net patients receiving a higher risk estimation among the 77 patients who would have experienced the primary outcome (P<0.001). Coronary computed tomographic angiography, however, would have resulted inappropriately in 98 net patients receiving a higher risk estimation, among the 923 patients who would not have experienced the primary outcome (P<0.001). Among patients who had a perioperative myocardial infarction, preoperative coronary anatomy showed extensive obstructive disease in 31% (22/71), obstructive disease in 41% (29/71), non-obstructive disease in 24% (17/71), and normal findings in 4% (3/71).Conclusions Though findings on coronary computed tomographic angiography can improve estimation of risk for patients who will experience perioperative cardiovascular death or myocardial infarction, findings are more than five times as likely to lead to an inappropriate overestimation of risk among patients who will not experience these outcomes. Perioperative myocardial infarction occurs across the spectrum of coronary artery disease, suggesting that there could be several pathophysiologic mechanisms.

Background Mineralocorticoid receptor antagonists (MRAs) have been associated with improved patient outcomes in patients with heart failure with reduced ejection fraction (HFrEF) but not preserved ejection fraction (HFpEF). We conducted a systematic review and meta-analysis of selective and nonselective MRAs in HFrEF and HFpEF. Methods We searched Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE. We included randomized controlled trials (RCT) of MRAs in adults with HFpEF or HFrEF if they reported data on major adverse cardiac events or drug safety. Results We identified 15 studies representing 16321 patients. MRAs were associated with a reduced risk of cardiovascular death (RR 0.81 [0.75–0.87], I 2 0%), all-cause mortality (RR 0.83 [0.77–0.88], I 2 0%), and cardiac hospitalizations (RR 0.80 [0.70–0.92], I 2 58.4%). However, an a-priori specified subgroup analysis demonstrated that these benefits were limited to HFrEF (cardiovascular death RR 0.79 [0.73–0.86], I 2 0%; all-cause mortality RR 0.81 [0.75–0.87], I 2 0%; cardiac hospitalizations RR 0.76 [0.64–0.90], I 2 68%), but not HFpEF (all-cause mortality RR 0.92 [0.79–1.08], I 2 0%; cardiac hospitalizations RR 0.91 [0.67–1.24], I 2 17%). MRAs increased the risk of hyperkalemia (RR 2.03 [1.78–2.31], I 2 0%). Nonselective MRAs, but not selective MRAs increased the risk of gynecomastia (RR 7.37 [4.42–12.30], I 2 0% vs. RR 0.74 [0.43–1.27], I 2 0%). Evidence was of moderate quality for cardiovascular death, all-cause mortality and cardiovascular hospitalizations; and high-quality for hyperkalemia and gynecomastia. Conclusions MRAs reduce the risk of adverse cardiac events in HFrEF but not HFpEF. MRA use in HFpEF increases the risk of harm from hyperkalemia and gynecomastia. Selective MRAs are equally effective as nonselective MRAs, without a risk of gynecomastia.

Introduction: Atrial fibrillation (AF) burden progresses with time. Among ischemic stroke (IS) patients, AF can be detected at different burden progression stages based on the timing and screening method. We hypothesized that AF detected after IS on 12-lead ECGs (ECG-AF) and via 14-day-Holter prolonged cardiac monitoring (AFDAS) are linked to lower IS recurrence risk than AF known before stroke occurrence (KAF) because of being at an earlier progression stage than KAF. Additionally, we posited that IS recurrence risk differences between AF types vary over time due to their differential progression stages. Patients and methods: Retrospective observational cohort study including IS/TIA patients with KAF, ECG-AF, and AFDAS [2018–2021]. Adjusted hazard ratios (aHR) were estimated using multivariable cause-specific Cox proportional-hazard models to compare IS recurrence between ECG-AF versus KAF and AFDAS versus KAF. Proportional hazards assumptions were tested to assess whether IS recurrence risk differences were time-varying. Results: Of 758 AF patients (385 KAF, 236 ECG-AF, 137 AFDAS), 603 received anticoagulation and 59 experienced a recurrent IS after 1441 patient-years of follow-up. No IS recurrence risk differences were observed at the end of follow-up between ECG-AF and KAF (aHR 0.67, 95% CI 0.36–1.26), although ECG-AF showed lower risk only within the first year (aHR 0.15; 95% CI 0.04–0.56). AFDAS exhibited a lower IS recurrence risk than KAF (aHR 0.22, 95% CI 0.08–0.63), without time-varying differences. Discussion: Differences in IS recurrence risk between ECG-AF and KAF varied over time. However, AFDAS showed a consistently lower IS risk than KAF throughout the entire study period. Graphical abstract