Validity and reliability of the Patient-Reported Outcomes Measurement Information System (PROMIS®) using computerized adaptive testing in patients with advanced chronic kidney disease.

BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS®) has been recommended for computerized adaptive testing (CAT) of health-related quality of life. This study compared the content, validity, and reliability of seven PROMIS CATs to the 12-item Short-Form Health Survey (SF-12) in patients with advanced chronic kidney disease. METHODS: Adult patients with chronic kidney disease and an estimated glomerular filtration rate under 30 mL/min/1.73 m2 who were not receiving dialysis treatment completed seven PROMIS CATs (assessing physical function, pain interference, fatigue, sleep disturbance, anxiety, depression, and the ability to participate in social roles and activities), the SF-12, and the PROMIS Pain Intensity single item and Dialysis Symptom Index at inclusion and 2 weeks. A content comparison was performed between PROMIS CATs and the SF-12. Construct validity of PROMIS CATs was assessed using Pearson's correlations. We assessed the test-retest reliability of all patient-reported outcome measures by calculating the intraclass correlation coefficient and minimal detectable change. RESULTS: In total, 207 patients participated in the study. A median of 45 items (10 minutes) were completed for PROMIS CATs. All PROMIS CATs showed evidence of sufficient construct validity. PROMIS CATs, most SF-12 domains and summary scores, and Dialysis Symptom Index showed sufficient test-retest reliability (intraclass correlation coefficient ≥ 0.70). PROMIS CATs had a lower minimal detectable change compared with the SF-12 (range, 5.7-7.4 compared with 11.3-21.7 across domains, respectively). CONCLUSION: PROMIS CATs showed sufficient construct validity and test-retest reliability in patients with advanced chronic kidney disease. PROMIS CATs required more items but showed better reliability than the SF-12. Future research is needed to investigate the feasibility of PROMIS CATs for routine nephrology care.

Patients with a Ruptured Abdominal Aortic Aneurysm Are Better Informed in Hospitals with an "EVAR-preferred" Strategy: An Instrumental Variable Analysis of the Dutch Surgical Aneurysm Audit.

BACKGROUND: While several observational studies suggested a lower postoperative mortality after minimal invasive endovascular aneurysm repair (EVAR) in patients with a ruptured abdominal aortic aneurysm (RAAA) compared to conventional open surgical repair (OSR), landmark randomized controlled trials have not been able to prove the superiority of EVAR over OSR. Randomized controlled trials contain a selected, homogeneous population, influencing external validity. Observational studies are biased and adjustment of confounders can be incomplete. Instrumental variable (IV) analysis (pseudorandomization) may help to answer the question if patients with an RAAA have lower postoperative mortality when undergoing EVAR compared to OSR. METHODS: This is an observational study including all patients with an RAAA, registered in the Dutch Surgical Aneurysm Audit between 2013 and 2017. The risk difference (RD) in postoperative mortality (30 days/in-hospital) between patients undergoing EVAR and OSR was estimated, in which adjustment for confounding was performed in 3 ways: linear model adjusted for observed confounders, propensity score model (multivariable logistic regression analysis), and IV analysis (two-stage least square regression), adjusting for observed and unobserved confounders, with the variation in percentage of EVAR per hospital as the IV instrument. RESULTS: 2419 patients with an RAAA (1489 OSR and 930 EVAR) were included. Unadjusted postoperative mortality was 34.9% after OSR and 22.6% after EVAR (RD 12.3%, 95% CI 8.5-16%). The RD adjusted for observed confounders using linear regression analysis and propensity score analysis was, respectively, 12.3% (95% CI 9.6-16.7%) and 13.2% (95%CI 9.3-17.1%) in favor of EVAR. Using IV analysis, adjusting for observed and unobserved confounders, RD was 8.9% (95% CI -1.1-18.9%) in favor of EVAR. CONCLUSIONS: Adjusting for observed confounders, patients with an RAAA undergoing EVAR had a significant better survival than OSR in a consecutive large cohort. Adjustment for unobserved confounders resulted in a clinical relevant RD. An "EVAR preference strategy" in patients with an RAAA could result in lower postoperative mortality.

Toward Optimizing Risk Adjustment in the Dutch Surgical Aneurysm Audit.

BACKGROUND: To compare hospital outcomes of aortic aneurysm surgery, casemix correction for preoperative variables is essential. Most of these variables can be deduced from mortality risk prediction models. Our aim was to identify the optimal set of preoperative variables associated with mortality to establish a relevant and efficient casemix model. METHODS: All patients prospectively registered between 2013 and 2016 in the Dutch Surgical Aneurysm Audit (DSAA) were included for the analysis. After multiple imputation for missing variables, predictors for mortality following univariable logistic regression were analyzed in a manual backward multivariable logistic regression model and compared with three standard mortality risk prediction models: Glasgow Aneurysm Score (GAS, mainly clinical parameters), Vascular Biochemical and Haematological Outcome Model (VBHOM, mainly laboratory parameters), and Dutch Aneurysm Score (DAS, both clinical and laboratory parameters). Discrimination and calibration were tested and considered good with a C-statistic > 0.8 and Hosmer-Lemeshow (H-L) P > 0.05. RESULTS: There were 12,401 patients: 9,537 (76.9%) elective patients (EAAA), 913 (7.4%) acute symptomatic patients (SAAA), and 1,951 (15.7%) patients with acute rupture (RAAA). Overall postoperative mortality was 6.5%; 1.8% after EAAA surgery, 6.6% after SAAA, and 29.6% after RAAA surgery. The optimal set of independent variables associated with mortality was a mix of clinical and laboratory parameters: gender, age, pulmonary comorbidity, operative setting, creatinine, aneurysm size, hemoglobin, Glasgow coma scale, electrocardiography, and systolic blood pressure (C-statistic 0.871). External validation overall of VBHOM, DAS, and GAS revealed C-statistics of 0.836, 0.782, and 0.761, with an H-L of 0.028, 0.00, and 0.128, respectively. CONCLUSIONS: The optimal set of variables for casemix correction in the DSAA comprises both clinical and laboratory parameters, which can be collected easily from electronic patient files and will lead to an efficient casemix model.

Failure to Rescue - a Closer Look at Mortality Rates Has No Added Value for Hospital Comparisons but Is Useful for Team Quality Assessment in Abdominal Aortic Aneurysm Surgery in The Netherlands.

OBJECTIVES: Failure to rescue (FTR) is a composite quality indicator, defined as the proportion of deceased patients following major complications. The aims of this study were to compare FTR with mortality for hospital comparisons in abdominal aortic aneurysm (AAA) surgery in The Netherlands and investigate hospital volume and associated factors. METHODS: Patients prospectively registered between 2013 and 2015 in the Dutch Surgical Aneurysm Audit (DSAA) were analysed. FTR was analysed for AAA patients and subgroups elective (EAAA) and acute (AAAA; symptomatic or ruptured) aneurysms. Variables and hospital volume were analysed by uni- and multivariable regression analysis. Adjusted hospital comparisons for mortality, major complications, and FTR were presented in funnel plots. Isomortality lines were constructed when presenting FTR and major complication rates. RESULTS: A total of 9258 patients were analysed in 61 hospitals: 7149 EAAA patients (77.2%) and 2109 AAAA patients (22.8%). There were 2785 (30.1%) patients with complications (unadjusted range 5-65% per hospital): 2161 (77.6%) with major and 624 (28.4%) patients with minor complications. Overall mortality was 6.6% (adjusted range 0-16% per hospital) and FTR was 28.4% (n = 613) (adjusted range 0-60% per hospital). Glasgow Coma Scale, age, pulse, creatinine, electrocardiography, and operative setting were independently associated with FTR. Hospital volume was not associated with FTR. In AAAA patients hospital volume was significantly associated with a lower adjusted major complication and mortality rate (OR 0.62, 95% CI 0.49-0.78; and 0.64, 95% CI 0.48-0.87). Four hospitals had a significant lower adjusted FTR with different major complication rates on different isomortality lines. CONCLUSIONS: There was more variation in FTR than in mortality between hospitals. FTR identified the same best performing hospitals as for mortality and therefore was of limited additional value in measuring quality of care for AAA surgery. FTR can be used for internal quality improvement with major complications in funnel plots and diagrams with isomortality lines.

National Comparison of Hospital Performances in Lung Cancer Surgery: The Role of Case Mix Adjustment.

BACKGROUND: When comparing hospitals on outcome indicators, proper adjustment for case mix (a combination of patient and disease characteristics) is indispensable. This study examines the need for case mix adjustment in evaluating hospital outcomes for non-small cell lung cancer surgery. METHODS: Data from the Dutch Lung Cancer Audit for Surgery were used to validate factors associated with postoperative 30-day mortality and complicated course with multivariable logistic regression models. Between-hospital variation in case mix was studied by calculating medians and interquartile ranges for separate factors on the hospital level and the "expected" outcomes per hospital as a composite measure. RESULTS: A total of 8,040 patients, distributed over 51 Dutch hospitals, were included for analysis. Mean observed postoperative mortality and complicated course were 2.2% and 13.6%, respectively. Age, American Society of Anesthesiologists classification, Eastern Cooperative Oncology Group performance score, lung function, extent of resection, tumor stage, and postoperative histopathologic findings were individual significant predictors for both outcomes of postoperative mortality and complicated course. A considerable variation of these case mix factors among hospital populations was observed, with the expected mortality and complicated course per hospital ranging from 1.4% to 3.2% and from 11.5% to 17.1%, respectively. CONCLUSIONS: The between-hospital variation in case mix of patients undergoing surgical treatment for non-small cell lung cancer emphasizes the importance of proper adjustment when comparing hospitals on outcome indicators.