Summary Background Recent reductions in average door-to-balloon (D2B) times have not been associated with decreases in mortality at the population level. We investigated this seemingly paradoxical ...finding by assessing components of this association at the individual and population levels simultaneously. We postulated that the changing population of patients undergoing primary percutaneous coronary intervention (pPCI) contributed to secular trends toward an increasing mortality risk, despite consistently decreased mortality in individual patients with shorter D2B times. Methods This was a retrospective study of ST-elevation myocardial infarction (STEMI) patients who underwent pPCI between Jan 1, 2005, and Dec 31, 2011, in the National Cardiovascular Data Registry (NCDR) CathPCI Registry. We looked for catheterisation laboratory visits associated with STEMI. We excluded patients not undergoing pPCI, transfer patients for pPCI, patients with D2B times less than 15 min or more than 3 h, and patients at hospitals that did not consistently report data across the study period. We assessed in-hospital mortality in the entire cohort and 6-month mortality in elderly patients aged 65 years or older matched to data from the Centers for Medicare and Medicaid Services. We built multilevel models to assess the relation between D2B time and in-hospital and 6-month mortality, including both individual and population-level components of this association after adjusting for patient and procedural factors. Findings 423 hospitals reported data on 150 116 procedures with a 55% increase in the number of patients undergoing pPCI at these facilities over time, as well as many changes in patient and procedural factors. Annual D2B times decreased significantly from a median of 86 min (IQR 65–109) in 2005 to 63 min (IQR 47–80) in 2011 (p<0·0001) with a concurrent rise in risk-adjusted in-hospital mortality (from 4·7% to 5·3%; p=0·06) and risk-adjusted 6-month mortality (from 12·9% to 14·4%; p=0·001). In multilevel models, shorter patient-specific D2B times were consistently associated at the individual level with lower in-hospital mortality (adjusted OR for each 10 min decrease 0·92; 95% CI 0·91–0·93; p<0·0001) and 6-month mortality (adjusted OR for each 10 min decrease, 0·94; 95% CI 0·93–0·95; p<0·0001). By contrast, risk-adjusted in-hospital and 6-month mortality at the population level, independent of patient-specific D2B times, rose in the growing and changing population of patients undergoing pPCI during the study period. Interpretation Shorter patient-specific D2B times were consistently associated with lower mortality over time, whereas secular trends suggest increased mortality risk in the growing and changing pPCI population. The absence of association of annual D2B time and changes in mortality at the population level should not be interpreted as an indication of its individual-level relation in patients with STEMI undergoing primary PCI. Funding National Heart, Lung, and Blood Institute.
Failure to reliably diagnose ARDS may be a major driver of negative clinical trials and underrecognition and treatment in clinical practice. We sought to examine the interobserver reliability of the ...Berlin ARDS definition and examine strategies for improving the reliability of ARDS diagnosis.
Two hundred five patients with hypoxic respiratory failure from four ICUs were reviewed independently by three clinicians, who evaluated whether patients had ARDS, the diagnostic confidence of the reviewers, whether patients met individual ARDS criteria, and the time when criteria were met.
Interobserver reliability of an ARDS diagnosis was “moderate” (kappa = 0.50; 95% CI, 0.40-0.59). Sixty-seven percent of diagnostic disagreements between clinicians reviewing the same patient was explained by differences in how chest imaging studies were interpreted, with other ARDS criteria contributing less (identification of ARDS risk factor, 15%; cardiac edema/volume overload exclusion, 7%). Combining the independent reviews of three clinicians can increase reliability to “substantial” (kappa = 0.75; 95% CI, 0.68-0.80). When a clinician diagnosed ARDS with “high confidence,” all other clinicians agreed with the diagnosis in 72% of reviews. There was close agreement between clinicians about the time when a patient met all ARDS criteria if ARDS developed within the first 48 hours of hospitalization (median difference, 5 hours).
The reliability of the Berlin ARDS definition is moderate, driven primarily by differences in chest imaging interpretation. Combining independent reviews by multiple clinicians or improving methods to identify bilateral infiltrates on chest imaging are important strategies for improving the reliability of ARDS diagnosis.
Abstract Background The optimal approach to assess risk of venous thromboembolism in hospitalized medical patients is unknown. We examined how well the Caprini risk assessment model predicts venous ...thromboembolism in hospitalized medical patients. Methods Between January 2011 and March 2014, venous thromboembolism events and risk factors were collected from non-intensive care unit medical patients hospitalized in facilities across Michigan. After calculation of the Caprini score for each patient, mixed logistic spline regression was used to determine the predicted probabilities of 90-day venous thromboembolism by receipt of pharmacologic prophylaxis across the Caprini risk continuum. Results A total of 670 (1.05%) of 63,548 eligible patients experienced a venous thromboembolism event within 90 days of hospital admission. The mean Caprini risk score was 4.94 (range, 0-28). Predictive modeling revealed a consistent linear increase in venous thromboembolism for Caprini scores between 1 and 10; estimates beyond a score of 10 were unstable. Receipt of pharmacologic prophylaxis resulted in a modest decrease in venous thromboembolism risk (odds ratio, 0.85; 95% confidence interval, 0.72-0.99; P = .04). However, the low overall incidence of venous thromboembolism led to large estimates of numbers needed to treat to prevent a single venous thromboembolism event. A Caprini cut-point demonstrating clear benefit of prophylaxis was not detected. Conclusions Although a linear association between the Caprini risk assessment model and the risk of venous thromboembolism was noted, an extremely low incidence of venous thromboembolism events in non-intensive care unit medical patients was observed. The Caprini risk assessment model was unable to identify a subset of medical patients who benefit from pharmacologic prophylaxis.
Background
Readmission rates after pneumonia, heart failure, and acute myocardial infarction hospitalizations are risk-adjusted for age, gender, and medical comorbidities and used to penalize ...hospitals.
Objective
To assess the impact of disability and social determinants of health on condition-specific readmissions beyond current risk adjustment.
Design, Setting, and Participants
Retrospective cohort study of Medicare patients using 1) linked Health and Retirement Study-Medicare claims data (HRS-CMS) and 2) Healthcare Cost and Utilization Project State Inpatient Databases (Florida, Washington) linked with ZIP Code-level measures from the Census American Community Survey (ACS-HCUP). Multilevel logistic regression models assessed the impact of disability and selected social determinants of health on readmission beyond current risk adjustment.
Main Measures
Outcomes measured were readmissions ≤30 days after hospitalizations for pneumonia, heart failure, or acute myocardial infarction. HRS-CMS models included disability measures (activities of daily living ADL limitations, cognitive impairment, nursing home residence, home healthcare use) and social determinants of health (spouse, children, wealth, Medicaid, race). ACS-HCUP model measures were ZIP Code-percentage of residents ≥65 years of age with ADL difficulty, spouse, income, Medicaid, and patient-level and hospital-level race.
Key Results
For pneumonia, ≥3 ADL difficulties (OR 1.61, CI 1.079–2.391) and prior home healthcare needs (OR 1.68, CI 1.204–2.355) increased readmission in HRS-CMS models (N = 1631); ADL difficulties (OR 1.20, CI 1.063–1.352) and ‘other’ race (OR 1.14, CI 1.001–1.301) increased readmission in ACS-HCUP models (N = 27,297). For heart failure, children (OR 0.66, CI 0.437–0.984) and wealth (OR 0.53, CI 0.349–0.787) lowered readmission in HRS-CMS models (N = 2068), while black (OR 1.17, CI 1.056–1.292) and ‘other’ race (OR 1.14, CI 1.036-1.260) increased readmission in ACS-HCUP models (N = 37,612). For acute myocardial infarction, nursing home status (OR 4.04, CI 1.212–13.440) increased readmission in HRS-CMS models (N = 833); ‘other’ patient-level race (OR 1.18, CI 1.012–1.385) and hospital-level race (OR 1.06, CI 1.001–1.125) increased readmission in ACS-HCUP models (N = 17,496).
Conclusions
Disability and social determinants of health influence readmission risk when added to the current Medicare risk adjustment models, but the effect varies by condition.
Genetic testing is important for breast and ovarian cancer risk reduction and treatment, yet little is known about its evolving use.
SEER records of women of age ≥ 20 years diagnosed with breast or ...ovarian cancer from 2013 to 2017 in California or Georgia were linked to the results of clinical germline testing through 2019. We measured testing trends, rates of variants of uncertain significance (VUS), and pathogenic variants (PVs).
One quarter (25.2%) of 187,535 patients with breast cancer and one third (34.3%) of 14,689 patients with ovarian cancer were tested; annually, testing increased by 2%, whereas the number of genes tested increased by 28%. The prevalence of test results by gene category for breast cancer cases in 2017 were
PVs 5.2%, and VUS 0.8%; breast cancer-associated genes or ovarian cancer-associated genes (
and
), PVs 3.7%, and VUS 12.0%; other actionable genes (
and
) PVs 0.6%, and VUS 0.5%; and other genes, PVs 0.3%, and VUS 2.6%. For ovarian cancer cases in 2017, the prevalence of test results were
, PVs 11.0%, and VUS 0.9%; breast or ovarian genes, PVs 4.0%, and VUS 12.6%; other actionable genes, PVs 0.7%, and VUS 0.4%; and other genes, PVs 0.3%, and VUS 0.6%. VUS rates doubled over time (2013 diagnoses: 11.2%; 2017 diagnoses: 26.8%), particularly for racial or ethnic minorities (47.8% Asian and 46.0% Black,
24.6% non-Hispanic White patients;
< .001).
A testing gap persists for patients with ovarian cancer (34.3% tested
nearly all recommended), whereas adding more genes widened a racial or ethnic gap in VUS results. Most PVs were in 20 breast cancer-associated genes or ovarian cancer-associated genes; testing other genes yielded mostly VUS. Quality improvement should focus on testing indicated patients rather than adding more genes.
ABSTRACTTimely and accurate diagnosis is foundational to good clinical practice and an essential first step to achieving optimal patient outcomes. However, a recent Institute of Medicine report ...concluded that most of us will experience at least one diagnostic error in our lifetime. The report argues for efforts to improve the reliability of the diagnostic process through better measurement of diagnostic performance. The diagnostic process is a dynamic team-based activity that involves uncertainty, plays out over time, and requires effective communication and collaboration among multiple clinicians, diagnostic services, and the patient. Thus, it poses special challenges for measurement. In this paper, we discuss how the need to develop measures to improve diagnostic performance could move forward at a time when the scientific foundation needed to inform measurement is still evolving. We highlight challenges and opportunities for developing potential measures of “diagnostic safety” related to clinical diagnostic errors and associated preventable diagnostic harm. In doing so, we propose a starter set of measurement concepts for initial consideration that seem reasonably related to diagnostic safety and call for these to be studied and further refined. This would enable safe diagnosis to become an organizational priority and facilitate quality improvement. Health-care systems should consider measurement and evaluation of diagnostic performance as essential to timely and accurate diagnosis and to the reduction of preventable diagnostic harm.
Background
The COVID-19 pandemic required a change in outpatient care delivery models, including shifting from in-person to virtual visits, which may have impacted care of vulnerable patients.
...Objective
To describe the changes in management, control, and outcomes in older people with type 2 diabetes (T2D) associated with the shift from in-person to virtual visits.
Design and Participants
In veterans aged ≥ 65 years with T2D, we assessed the rates of visits (in person, virtual), A1c measurements, antidiabetic deintensification/intensification, ER visits and hospitalizations (for hypoglycemia, hyperglycemia, other causes), and A1c level, in March 2020 and April–November 2020 (pandemic period). We used negative binomial regression to assess change over time (reference: pre-pandemic period, July 2018 to February 2020), by baseline Charlson Comorbidity Index (CCI; > 2 vs. <= 2) and A1c level.
Key Results
Among 740,602 veterans (mean age 74.2 SD 6.6 years), there were 55% (95% CI 52–58%) fewer in-person visits, 821% (95% CI 793–856%) more virtual visits, 6% (95% CI 1–11%) fewer A1c measurements, and 14% (95% CI 10–17%) more treatment intensification during the pandemic, relative to baseline. Patients with CCI > 2 had a 14% (95% CI 12–16%) smaller relative increase in virtual visits than those with CCI <= 2. We observed a seasonality of A1c level and treatment modification, but no association of either with the pandemic. After a decrease at the beginning of the pandemic, there was a rebound in other-cause (but not hypo- and hyperglycemia-related) ER visits and hospitalizations from June to November 2020.
Conclusion
Despite a shift to virtual visits and a decrease in A1c measurement during the pandemic, we observed no association with A1c level or short-term T2D-related outcomes, providing some reassurance about the adequacy of virtual visits. Further studies should assess the longer-term effects of shifting to virtual visits in different populations to help individualize care, improve efficiency, and maintain appropriate care while reducing overuse.
Many patients have uncontrolled blood pressure (BP) because they are not taking medications as prescribed. Providers may have difficulty accurately assessing adherence. Providers need to assess ...medication adherence to decide whether to address uncontrolled BP by improving adherence to the current prescribed regimen or by intensifying the BP treatment regimen by increasing doses or adding more medications.
We examined how provider assessments of adherence with antihypertensive medications compared with refill records, and how providers' assessments were associated with decisions to intensify medications for uncontrolled BP. We studied a cross-sectional cohort of 1169 veterans with diabetes presenting with BP ≥140/90 to 92 primary care providers at 9 Veterans Affairs (VA) facilities from February 2005 to March 2006. Using VA pharmacy records, we utilized a continuous multiple-interval measure of medication gaps (CMG) to assess the proportion of time in prior year that patient did not possess the prescribed medications; CMG ≥20% is considered clinically significant non-adherence. Providers answered post-visit Likert-scale questions regarding their assessment of patient adherence to BP medications. The BP regimen was considered intensified if medication was added or increased without stopping or decreasing another medication.
1064 patients were receiving antihypertensive medication regularly from the VA; the mean CMG was 11.3%. Adherence assessments by providers correlated poorly with refill history. 211 (20%) patients did not have BP medication available for ≥ 20% of days; providers characterized 79 (37%) of these 211 patients as having significant non-adherence, and intensified medications for 97 (46%). Providers intensified BP medications for 451 (42%) patients, similarly whether assessed by provider as having significant non-adherence (44%) or not (43%).
Providers recognized non-adherence for less than half of patients whose pharmacy records indicated significant refill gaps, and often intensified BP medications even when suspected serious non-adherence. Making an objective measure of adherence such as the CMG available during visits may help providers recognize non-adherence to inform prescribing decisions.
IMPORTANCE: Older patients with diabetes mellitus receiving medical treatment whose blood pressure (BP) or blood glucose level are potentially dangerously low are rarely deintensified. Given the ...established risks of low blood pressure and blood glucose, this is a major opportunity to decrease medication harm. OBJECTIVE: To examine the rate of BP- and blood glucose–lowering medicine deintensification among older patients with type 1 or 2 diabetes mellitus who potentially receive overtreatment. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study conducted using data from the US Veterans Health Administration. Participants included 211 667 patients older than 70 years with diabetes mellitus who were receiving active treatment (defined as BP-lowering medications other than angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, or glucose-lowering medications other than metformin hydrochloride) from January 1 to December 31, 2012. Data analysis was performed December 10, 2013, to July 20, 2015. EXPOSURES: Participants were eligible for deintensification of treatment if they had low BP or a low hemoglobin A1c (HbA1c) level in their last measurement in 2012. We defined very low BP as less than 120/65 mm Hg, moderately low as systolic BP of 120 to 129 mm Hg or diastolic BP (DBP) less than 65 mm Hg, very low HbA1c as less than 6.0%, and moderately low HbA1c as 6.0% to 6.4%. All other values were not considered low. MAIN OUTCOMES AND MEASURES: Medication deintensification, defined as discontinuation or dosage decrease within 6 months after the index measurement. RESULTS: The actively treated BP cohort included 211 667 participants, more than half of whom had moderately or very low BP levels. Of 104 486 patients with BP levels that were not low, treatment in 15.1% was deintensified. Of 25 955 patients with moderately low BP levels, treatment in 16.0% was deintensified. Among 81 226 patients with very low BP levels, 18.8% underwent BP medication deintensification. Of patients with very low BP levels whose treatment was not deintensified, only 0.2% had a follow-up BP measurement that was elevated (BP ≥140/90 mm Hg). The actively treated HbA1c cohort included 179 991 participants. Of 143 305 patients with HbA1c levels that were not low, treatment in 17.5% was deintensified. Of 23 769 patients with moderately low HbA1c levels, treatment in 20.9% was deintensified. Among 12 917 patients with very low HbA1c levels, 27.0% underwent medication deintensification. Of patients with very low HbA1c levels whose treatment was not deintensified, fewer than 0.8% had a follow-up HbA1c measurement that was elevated (≥7.5%). CONCLUSIONS AND RELEVANCE: Among older patients whose treatment resulted in very low levels of HbA1c or BP, 27% or fewer underwent deintensification, representing a lost opportunity to reduce overtreatment. Low HbA1c or BP values or low life expectancy had little association with deintensification events. Practice guidelines and performance measures should place more focus on reducing overtreatment through deintensification.
Inappropriate diagnosis of infections results in antibiotic overuse and may delay diagnosis of underlying conditions. Here, we describe the development and characteristics of two safety measures of ...inappropriate diagnosis of urinary tract infection (UTI) and community-acquired pneumonia (CAP), the most common inpatient infections on general medicine services.
Measures were developed from guidelines and literature and adapted based on data from patients hospitalized with UTI and CAP in 49 Michigan hospitals and feedback from end-users, a technical expert panel (TEP), and a patient focus group. Each measure was assessed for reliability, validity, feasibility, and usability.
Two measures, now endorsed by the National Quality Forum (NQF), were developed. Measure reliability (derived from 24,483 patients) was excellent (0.90 for UTI; 0.91 for CAP). Both measures had strong validity demonstrated through a) face validity by hospital users, the TEPs, and patient focus group, b) implicit case review (ĸ 0.72 for UTI; ĸ 0.72 for CAP), and c) rare case misclassification (4% for UTI; 0% for CAP) due to data errors (<2% for UTI; 6.3% for CAP). Measure implementation through hospital peer comparison in Michigan hospitals (2017 to 2020) demonstrated significant decreases in inappropriate diagnosis of UTI and CAP (37% and 32%, respectively, p < 0.001), supporting usability.
We developed highly reliable, valid, and usable measures of inappropriate diagnosis of UTI and CAP for hospitalized patients. Hospitals seeking to improve diagnostic safety, antibiotic use, and patient care should consider using these measures to reduce inappropriate diagnosis of CAP and UTI.
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