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Objective To determine whether informed consent for surgical procedures performed in US hospitals meet a minimum standard of quality, we developed and tested a quality measure of informed consent documents. Design Retrospective observational study of informed consent documents. Setting 25 US hospitals, diverse in size and geographical region. Cohort Among Medicare fee-for- service patients undergoing elective procedures in participating hospitals, we assessed the informed consent documents associated with these procedures. We aimed to review 100 qualifying procedures per hospital; the selected sample was representative of the procedure types performed at each hospital. Primary outcome The outcome was hospital quality of informed consent documents, assessed by two independent raters using an eight-item instrument previously developed for this measure and scored on a scale of 0–20, with 20 representing the highest quality. The outcome was reported as the mean hospital document score and the proportion of documents meeting a quality threshold of 10. Reliability of the hospital score was determined based on subsets of randomly selected documents; face validity was assessed using stakeholder feedback. Results Among 2480 informed consent documents from 25 hospitals, mean hospital scores ranged from 0.6 (95% CI 0.3 to 0.9) to 10.8 (95% CI 10.0 to 11.6). Most hospitals had at least one document score at least 10 out of 20 points, but only two hospitals had >50% of their documents score above a 10-point threshold. The Spearman correlation of the measures score was 0.92. Stakeholders reported that the measure was important, though some felt it did not go far enough to assess informed consent quality. Conclusion All hospitals performed poorly on a measure of informed consent document quality, though there was some variation across hospitals. Measuring the quality of hospital’s informed consent documents can serve as a first step in driving attention to gaps in quality. [ABSTRACT FROM AUTHOR]

Objective To develop a nationally applicable tool for assessing the quality of informed consent documents for elective procedures. Design Mixed qualitative-quantitative approach. Setting Convened seven meetings with stakeholders to obtain input and feedback on the tool. Participants Team of physician investigators, measure development experts, and a working group of nine patients and patient advocates (caregivers, advocates for vulnerable populations and patient safety experts) from different regions of the country. Interventions With stakeholder input, we identified elements of high-quality informed consent documents, aggregated into three domains: content, presentation and timing. Based on this comprehensive taxonomy of key elements, we convened the working group to offer input on the development of an abstraction tool to assess the quality of informed consent documents in three phases: (1) selecting the highest-priority elements to be operationalised as items in the tool; (2) iteratively refining and testing the tool using a sample of qualifying informed consent documents from eight hospitals; and (3) developing a scoring approach for the tool. Finally, we tested the reliability of the tool in a subsample of 250 informed consent documents from 25 additional hospitals. Outcomes Abstraction tool to evaluate the quality of informed consent documents. Results We identified 53 elements of informed consent quality; of these, 15 were selected as highest priority for inclusion in the abstraction tool and 8 were feasible to measure. After seven cycles of iterative development and testing of survey items, and development and refinement of a training manual, two trained raters achieved high item-level agreement, ranging from 92% to 100%. Conclusions We identified key quality elements of an informed consent document and operationalised the highest-priority elements to define a minimum standard for informed consent documents. This tool is a starting point that can enable hospitals and other providers to evaluate and improve the quality of informed consent. [ABSTRACT FROM AUTHOR]

Objective To compare trends in readmission rates among safety net and non-safety net hospitals under the US Hospital Readmission Reduction Program (HRRP). Design A retrospective time series analysis using Medicare administrative claims data from January 2008 to June 2015. Setting We examined 3254 US hospitals eligible for penalties under the HRRP, categorised as safety net or non-safety net hospitals based on the hospital's proportion of patients with low socioeconomic status. Participants Admissions for Medicare fee-for-service patients, age ≥65 years, discharged alive, who had a valid five-digit zip code and did not have a principal discharge diagnosis of cancer or psychiatric illness were included, for a total of 52 516 213 index admissions. Primary and secondary outcome measures Mean hospital-level, all-condition, 30-day risk-adjusted standardised unplanned readmission rate, measured quarterly, along with quarterly rate of change, and an interrupted time series examining: April-June 2010, after HRRP was passed, and October-December 2012, after HRRP penalties were implemented. Results 58.0% (SD 15.3) of safety net hospitals and 17.1% (SD 10.4) of non-safety net hospitals' patients were in the lowest quartile of socioeconomic status. The mean safety net hospital standardised readmission rate declined from 17.0% (SD 3.7) to 13.6% (SD 3.6), whereas the mean non-safety net hospital declined from 15.4% (SD 3.0) to 12.7% (SD 2.5). The absolute difference in rates between safety net and non-safety net hospitals declined from 1.6% (95% CI 1.3 to 1.9) to 0.9% (0.7 to 1.2). The quarterly decline in standardised readmission rates was 0.03 percentage points (95% CI 0.03 to 0.02, p<0.001) greater among safety net hospitals over the entire study period, and no differential change among safety net and non-safety net hospitals was found after either HRRP was passed or penalties enacted. Conclusions Since HRRP was passed and penalties implemented, readmission rates for safety net hospitals have decreased more rapidly than those for non-safety net hospitals. [ABSTRACT FROM AUTHOR]

Objectives To determine whether high performing hospitals with low 30 day risk standardized readmission rates have a lower proportion of readmissions from specific diagnoses and time periods after admission or instead have a similar distribution of readmission diagnoses and timing to lower performing institutions. Design Retrospective cohort study. Setting Medicare beneficiaries in the United States. Participants Patients aged 65 and older who were readmitted within 30 days after hospital admission for heart failure, acute myocardial infarction, or pneumonia in 2007-09. Main outcome measures Readmission diagnoses were classified with a modified version of the Centers for Medicare and Medicaid Services' condition categories, and readmission timing was classified by day (0-30) after hospital discharge. Hospital 30 day risk standardized readmission rates over the three years of study were calculated with public reporting methods of the US federal government, and hospitals were categorized with bootstrap analysis as having high, average, or low readmission performance for each index condition. High and low performing hospitals had ≥95% probability of having an interval estimate respectively less than or greater than the national 30 day readmission rate over the three year period of study. All remaining hospitals were considered average performers. Results For readmissions in the 30 days after the index admission, there were 320 003 after 1 291 211 admissions for heart failure (4041 hospitals), 102 536 after 517 827 admissions for acute myocardial infarction (2378 hospitals), and 208 438 after 1 135 932 admissions for pneumonia (4283 hospitals). The distribution of readmissions by diagnosis was similar across categories of hospital performance for all three conditions. High performing hospitals had fewer readmissions for all common diagnoses. Median time to readmission was similar by hospital performance for heart failure and acute myocardial infarction, though was 1.4 days longer among high versus low performing hospitals for pneumonia (P<0.001). Findings were unchanged after adjustment for other hospital characteristics potentially associated with readmission patterns. Conclusions High performing hospitals have proportionately fewer 30 day readmissions without differences in readmission diagnoses and timing, suggesting the possible benefit of strategies that lower risk of readmission globally rather than for specific diagnoses or time periods after hospital stay. [ABSTRACT FROM AUTHOR]

The article presents the study which examined the readmission performance and patterns of readmission of high performing hospitals with low 30 day readmission rates and lower performing hospitals with higher rates of readmission. The study was conducted to Medicare beneficiaries aged 65 and older in the U.S. The results showed that hospitals could best lessen readmissions with strategies that reduce readmission risk worldwide.