Changes in Older Adult Trauma Quality When Evaluated Using Longer-Term Outcomes vs In-Hospital Mortality.

Importance: Lack of knowledge about longer-term outcomes remains a critical blind spot for trauma systems. Recent efforts have expanded trauma quality evaluation to include a broader array of postdischarge quality metrics. It remains unknown how such quality metrics should be used. Objective: To examine the utility of implementing recommended postdischarge quality metrics as a composite score and ascertain how composite score performance compares with that of in-hospital mortality for evaluating associations with hospital-level factors. Design, Setting, and Participants: This national hospital-level quality assessment evaluated hospital-level care quality using 100% Medicare fee-for-service claims of older adults (aged ≥65 years) hospitalized with primary diagnoses of trauma, hip fracture, and severe traumatic brain injury (TBI) between January 1, 2014, and December 31, 2015. Hospitals with annual volumes encompassing 10 or more of each diagnosis were included. The data analysis was performed between January 1, 2021, and December 31, 2022. Exposures: Reliability-adjusted quality metrics used to calculate composite scores included hospital-specific performance on mortality, readmission, and patients' average number of healthy days at home (HDAH) within 30, 90, and 365 days among older adults hospitalized with all forms of trauma, hip fracture, and severe TBI. Main Outcomes and Measures: Associations with hospital-level factors were compared using volume-weighted multivariable logistic regression. Results: A total of 573 554 older adults (mean [SD] age, 83.1 [8.3] years; 64.8% female; 35.2% male) from 1234 hospitals were included. All 27 reliability-adjusted postdischarge quality metrics significantly contributed to the composite score. The most important drivers were 30- and 90-day readmission, patients' average number of HDAH within 365 days, and 365-day mortality among all trauma patients. Associations with hospital-level factors revealed predominantly anticipated trends when older adult trauma quality was evaluated using composite scores (eg, worst performance was associated with decreased older adult trauma volume [odds ratio, 0.89; 95% CI, 0.88-0.90]). Results for in-hospital mortality showed inverted associations for each considered hospital-level factor and suggested that compared with nontrauma centers, level 1 trauma centers had a 17 times higher risk-adjusted odds of worst (highest quantile) vs best (lowest quintile) performance (odds ratio, 17.08; 95% CI, 16.17-18.05). Conclusions and Relevance: The study results challenge historical notions about the adequacy of in-hospital mortality as the single measure of older adult trauma quality and suggest that, when it comes to older adults, decisions about how quality is evaluated can profoundly alter understandings of what constitutes best practices for care. Composite scores appear to offer a promising means by which postdischarge quality metrics could be used.

Beyond In-hospital Mortality: Use of Postdischarge Quality-Metrics Provides a More Complete Picture of Older Adult Trauma Care.

OBJECTIVE: To identify the distributions of and extent of variability among 3 new sets of postdischarge quality-metrics measured within 30/90/365 days designed to better account for the unique health needs of older trauma patients: mortality (expansion of the current in-hospital standard), readmission (marker of health-system performance and care coordination), and patients' average number of healthy days at home (marker of patient functional status). BACKGROUND: Traumatic injuries are a leading cause of death and loss of independence for the increasing number of older adults living in the United States. Ongoing efforts seek to expand quality evaluation for this population. METHODS: Using 100% Medicare claims, we calculated hospital-specific reliability-adjusted postdischarge quality-metrics for older adults aged 65 years or older admitted with a primary diagnosis of trauma, older adults with hip fracture, and older adults with severe traumatic brain injury. Distributions for each quality-metric within each population were assessed and compared with results for in-hospital mortality, the current benchmarking standard. RESULTS: A total of 785,867 index admissions (305,186 hip fracture and 92,331 severe traumatic brain injury) from 3692 hospitals were included. Within each population, use of postdischarge quality-metrics yielded a broader range of outcomes compared with reliance on in-hospital mortality alone. None of the postdischarge quality-metrics consistently correlated with in-hospital mortality, including death within 1 year [ r =0.581 (95% CI, 0.554-0.608)]. Differences in quintile-rank revealed that when accounting for readmissions (8.4%, κ=0.029) and patients' average number of healthy days at home (7.1%, κ=0.020), as many as 1 in 14 hospitals changed from the best/worst performance under in-hospital mortality to the completely opposite quintile rank. CONCLUSIONS: The use of new postdischarge quality-metrics provides a more complete picture of older adult trauma care: 1 with greater room for improvement and better reflection of multiple aspects of quality important to the health and recovery of older trauma patients when compared with reliance on quality benchmarking based on in-hospital mortality alone.

Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM): Rationale for Study Design.

RATIONALE: Colorectal cancer (CRC) is preventable through screening, with colonoscopy and fecal occult blood testing comprising the two most commonly used screening tests. Given the differences in complexity, risk, and cost, it is important to understand these tests' comparative effectiveness. STUDY DESIGN: The CONFIRM Study is a large, pragmatic, multicenter, randomized, parallel group trial to compare screening with colonoscopy vs. the annual fecal immunochemical test (FIT) in 50,000 average risk individuals. CONFIRM examines whether screening colonoscopy will be superior to a FIT-based screening program in the prevention of CRC mortality measured over 10 years. Eligible individuals 50-75 years of age and due for CRC screening are recruited from 46 Veterans Affairs (VA) medical centers. Participants are randomized to either colonoscopy or annual FIT. Results of colonoscopy are managed as per usual care and study participants are assessed for complications. Participants testing FIT positive are referred for colonoscopy. Participants are surveyed annually to determine if they have undergone colonoscopy or been diagnosed with CRC. The primary endpoint is CRC mortality. The secondary endpoints are (1) CRC incidence (2) complications of screening colonoscopy, and (3) the association between colonoscopists' characteristics and neoplasia detection, complications and post-colonoscopy CRC. CONFIRM leverages several key characteristics of the VA's integrated healthcare system, including a shared medical record with national databases, electronic CRC screening reminders, and a robust national research infrastructure with experience in conducting large-scale clinical trials. When completed, CONFIRM will be the largest intervention trial conducted within the VA (ClinicalTrials.gov identifier: NCT01239082).

Pioglitazone after Ischemic Stroke or Transient Ischemic Attack.

BACKGROUND: Patients with ischemic stroke or transient ischemic attack (TIA) are at increased risk for future cardiovascular events despite current preventive therapies. The identification of insulin resistance as a risk factor for stroke and myocardial infarction raised the possibility that pioglitazone, which improves insulin sensitivity, might benefit patients with cerebrovascular disease. METHODS: In this multicenter, double-blind trial, we randomly assigned 3876 patients who had had a recent ischemic stroke or TIA to receive either pioglitazone (target dose, 45 mg daily) or placebo. Eligible patients did not have diabetes but were found to have insulin resistance on the basis of a score of more than 3.0 on the homeostasis model assessment of insulin resistance (HOMA-IR) index. The primary outcome was fatal or nonfatal stroke or myocardial infarction. RESULTS: By 4.8 years, a primary outcome had occurred in 175 of 1939 patients (9.0%) in the pioglitazone group and in 228 of 1937 (11.8%) in the placebo group (hazard ratio in the pioglitazone group, 0.76; 95% confidence interval [CI], 0.62 to 0.93; P=0.007). Diabetes developed in 73 patients (3.8%) and 149 patients (7.7%), respectively (hazard ratio, 0.48; 95% CI, 0.33 to 0.69; P<0.001). There was no significant between-group difference in all-cause mortality (hazard ratio, 0.93; 95% CI, 0.73 to 1.17; P=0.52). Pioglitazone was associated with a greater frequency of weight gain exceeding 4.5 kg than was placebo (52.2% vs. 33.7%, P<0.001), edema (35.6% vs. 24.9%, P<0.001), and bone fracture requiring surgery or hospitalization (5.1% vs. 3.2%, P=0.003). CONCLUSIONS: In this trial involving patients without diabetes who had insulin resistance along with a recent history of ischemic stroke or TIA, the risk of stroke or myocardial infarction was lower among patients who received pioglitazone than among those who received placebo. Pioglitazone was also associated with a lower risk of diabetes but with higher risks of weight gain, edema, and fracture. (Funded by the National Institute of Neurological Disorders and Stroke; ClinicalTrials.gov number, NCT00091949.).

Proximity to natural gas wells and reported health status: results of a household survey in Washington County, Pennsylvania.

BACKGROUND: Little is known about the environmental and public health impact of unconventional natural gas extraction activities, including hydraulic fracturing, that occur near residential areas. OBJECTIVES: Our aim was to assess the relationship between household proximity to natural gas wells and reported health symptoms. METHODS: We conducted a hypothesis-generating health symptom survey of 492 persons in 180 randomly selected households with ground-fed wells in an area of active natural gas drilling. Gas well proximity for each household was compared with the prevalence and frequency of reported dermal, respiratory, gastrointestinal, cardiovascular, and neurological symptoms. RESULTS: The number of reported health symptoms per person was higher among residents living < 1 km (mean ± SD, 3.27 ± 3.72) compared with > 2 km from the nearest gas well (mean ± SD, 1.60 ± 2.14; p = 0.0002). In a model that adjusted for age, sex, household education, smoking, awareness of environmental risk, work type, and animals in house, reported skin conditions were more common in households < 1 km compared with > 2 km from the nearest gas well (odds ratio = 4.1; 95% CI: 1.4, 12.3; p = 0.01). Upper respiratory symptoms were also more frequently reported in persons living in households < 1 km from gas wells (39%) compared with households 1-2 km or > 2 km from the nearest well (31 and 18%, respectively) (p = 0.004). No equivalent correlation was found between well proximity and other reported groups of respiratory, neurological, cardiovascular, or gastrointestinal conditions. CONCLUSION: Although these results should be viewed as hypothesis generating, and the population studied was limited to households with a ground-fed water supply, proximity of natural gas wells may be associated with the prevalence of health symptoms including dermal and respiratory conditions in residents living near natural gas extraction activities. Further study of these associations, including the role of specific air and water exposures, is warranted.

American Thyroid Association design and feasibility of a prospective randomized controlled trial of prophylactic central lymph node dissection for papillary thyroid carcinoma.

BACKGROUND: The role of prophylactic central lymph node dissection in papillary thyroid cancer (PTC) is controversial in patients who have no pre- or intraoperative evidence of nodal metastasis (clinically N0; cN0). The controversy relates to its unproven role in reducing recurrence rates while possibly increasing morbidity (permanent hypoparathyroidism and unintentional recurrent laryngeal nerve injury). METHODS AND RESULTS: We examined the design and feasibility of a multi-institutional prospective randomized controlled trial of prophylactic central lymph node dissection in cN0 PTC. Assuming a 7-year study with 4 years of enrollment, 5 years of average follow-up, a recurrence rate of 10% after 7 years, a 25% relative reduction in the rate of the primary endpoint (newly identified structural disease; i.e., persistent, recurrent, or distant metastatic disease) with central lymph node dissection and an annual dropout rate of 3%, a total of 5840 patients would have to be included in the study to achieve at least 80% statistical power. Similarly, given the low rates of morbidity, several thousands of patients would need to be included to identify a significant difference in rates of permanent hypoparathyroidism and unintentional recurrent laryngeal nerve injury. CONCLUSION: Given the low rates of both newly identified structural disease and morbidity after surgery for cN0 PTC, prohibitively large sample sizes would be required for sufficient statistical power to demonstrate significant differences in outcomes. Thus, a prospective randomized controlled trial of prophylactic central lymph node dissection in cN0 PTC is not readily feasible.

Methodological issues in comparative effectiveness research: clinical trials.

The US Department of Veterans Affairs (VA) Cooperative Studies Program has been conducting comparative effectiveness clinical trials for nearly 4 decades in many disease areas, including cardiovascular disease/surgery, diabetes mellitus, mental health, neurologic disorders, cancer, infectious diseases, and rheumatoid arthritis. The features that have made this program advantageous for conducting comparative effectiveness clinical trials are described along with methodological considerations for future trials based on lessons learned from its experience conducting these types of studies. Some of the lessons learned involve managing risk factors, clinical equipoise, patient preferences, evolving technology, the use of usual care as a comparator and pharmaceutical issues related to study drug blinding. These issues are not unique to the VA but can play an important role in enabling valid comparisons between treatments that may have differences in delivery or mechanisms of action and could affect the execution and feasibility of conducting a clinical trial with a comparative effectiveness aim. We also outline some future directions for comparative effectiveness clinical trials.

Comparative effectiveness research: what kind of studies do we need?

Comparative effectiveness research (CER) is increasingly popular, yet discussions of its conduct and consequences often overlook the extensive history of comparing different therapeutic options in patient-oriented research. In particular, research in the Department of Veterans Affairs (VA) has included a decades-long focus on generating information that can enhance medical decision making and improve health outcomes. Categories of such research include multisite randomized controlled trials (conducted by the Cooperative Studies Program) and observational studies involving either primary or secondary data collection. As representative examples from cardiology, a landmark VA clinical trial published in the 1970s evaluated the benefits of coronary artery bypass grafting surgery among patients with angina; a VA trial initiated in the 1990s, and identified formally as CER, demonstrated that percutaneous coronary intervention is not superior to optimal medical therapy; and a database investigation using information from the VA electronic medical record system in the 2000s found that use of proton pump inhibitor medication is associated with the attenuation of the benefits of clopidogrel among patients hospitalized for acute coronary syndrome. A review of these (and other) selected projects, based on their type of study design, serves to highlight the strengths, limitations, and potential of CER.

Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial.

CONTEXT: Limited data are available to assess whether endovascular repair of abdominal aortic aneurysm (AAA) improves short-term outcomes compared with traditional open repair. OBJECTIVE: To compare postoperative outcomes up to 2 years after endovascular or open repair of AAA in a planned interim report of a 9-year trial. DESIGN, SETTING, AND PATIENTS: A randomized, multicenter clinical trial of 881 veterans (aged > or = 49 years) from 42 Veterans Affairs Medical Centers with eligible AAA who were candidates for both elective endovascular repair and open repair of AAA. The trial is ongoing and this report describes the period between October 15, 2002, and October 15, 2008. INTERVENTION: Elective endovascular (n = 444) or open (n = 437) repair of AAA. MAIN OUTCOME MEASURES: Procedure failure, secondary therapeutic procedures, length of stay, quality of life, erectile dysfunction, major morbidity, and mortality. RESULTS: Mean follow-up was 1.8 years. Perioperative mortality (30 days or inpatient) was lower for endovascular repair (0.5% vs 3.0%; P = .004), but there was no significant difference in mortality at 2 years (7.0% vs 9.8%, P = .13). Patients in the endovascular repair group had reduced median procedure time (2.9 vs 3.7 hours), blood loss (200 vs 1000 mL), transfusion requirement (0 vs 1.0 units), duration of mechanical ventilation (3.6 vs 5.0 hours), hospital stay (3 vs 7 days), and intensive care unit stay (1 vs 4 days), but required substantial exposure to fluoroscopy and contrast. There were no differences between the 2 groups in major morbidity, procedure failure, secondary therapeutic procedures, aneurysm-related hospitalizations, health-related quality of life, or erectile function. CONCLUSIONS: In this report of short-term outcomes after elective AAA repair, perioperative mortality was low for both procedures and lower for endovascular than open repair. The early advantage of endovascular repair was not offset by increased morbidity or mortality in the first 2 years after repair. Longer-term outcome data are needed to fully assess the relative merits of the 2 procedures. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00094575.

Assessing multiple medication use with probabilities of benefits and harms.

OBJECTIVE: A quantitative framework to assess harms and benefits of candidate medications in the context of drugs that a patient is already taking is proposed. METHOD: Probabilities of harms and benefits of a given medication are averaged to yield a utility value. The utility values of all medications under consideration are combined as a geometric mean to yield an overall measure of favorability. The grouping of medications yielding the highest favorability value is chosen. RESULTS: Five examples of choosing between widely used candidate medications demonstrate the feasibility of the proposed framework. DISCUSSION: The framework proposed provides a simple method for considering the trade-offs involved in prescribing multiple medications. It can be adapted to include additional parameters representing severity of condition, prioritization of outcomes, patient preferences, dosages, and medication interactions. Inconsistent reporting in the medical literature of data about benefits and harms of medications, dosages, and interactions constitutes its primary limitation.

The effectiveness of screening for prostate cancer: a nested case-control study.

BACKGROUND: Screening for prostate cancer is done commonly in clinical practice, using prostate-specific antigen (PSA) tests or digital rectal examination (DRE). Evidence is lacking, however, to confirm a survival benefit among screened patients. We evaluated the effectiveness of PSA, with or without DRE, in reducing mortality. METHODS: We conducted a multicenter nested case-control study at 10 Veterans Affairs medical centers in New England. Among 71 661 patients receiving ambulatory care between 1989 and 1990, 501 case patients were identified as men who were diagnosed as having adenocarcinoma of the prostate from 1991 through 1995 and who died sometime between 1991 and 1999. Control patients were men who were alive at the time the corresponding case patient had died, matched (1:1 ratio) for age and Veterans Affairs facility. The exposure variable (determined blind to case-control status) was whether PSA testing or DRE was performed for screening prior to the diagnosis of prostate cancer among case patients, with the same time interval for control patients. The association of screening and overall or cause-specific (prostate cancer) mortality was adjusted for race and comorbidity. RESULTS: A benefit of screening was not found in our primary analysis assessing PSA screening and all-cause mortality (adjusted odds ratio, 1.08; 95% confidence interval, 0.71-1.64; P=.72), nor in a secondary analysis of PSA and/or DRE screening and cause-specific mortality (adjusted odds ratio, 1.13; 95% confidence interval, 0.63-2.06; P=.68). CONCLUSIONS: These results do not suggest that screening with PSA or DRE is effective in reducing mortality. Recommendations for obtaining "verbal informed consent" from men regarding such screening should continue.