N. Chantelle Hardy

Developing a simplified consent form for biobanking.

Background Consent forms have lengthened over time and become harder for participants to understand. We sought to demonstrate the feasibility of creating a simplified consent form for biobanking that comprises the minimum information necessary to meet ethical and regulatory requirements. We then gathered preliminary data concerning its content from hypothetical biobank participants. Methodology/Principal Findings We followed basic principles of plain-language writing and incorporated into a 2-page form (not including the signature page) those elements of information required by federal regulations and recommended by best practice guidelines for biobanking. We then recruited diabetes patients from community-based practices and randomized half (n = 56) to read the 2-page form, first on paper and then a second time on a tablet computer. Participants were encouraged to use “More information” buttons on the electronic version whenever they had questions or desired further information. These buttons led to a series of “Frequently Asked Questions” (FAQs) that contained additional detailed information. Participants were asked to identify specific sentences in the FAQs they thought would be important if they were considering taking part in a biorepository. On average, participants identified 7 FAQ sentences as important (mean 6.6, SD 14.7, range: 0–71). No one sentence was highlighted by a majority of participants; further, 34 (60.7%) participants did not highlight any FAQ sentences. Conclusions Our preliminary findings suggest that our 2-page form contains the information that most prospective participants identify as important. Combining simplified forms with supplemental material for those participants who desire more information could help minimize consent form length and complexity, allowing the most substantively material information to be better highlighted and enabling potential participants to read the form and ask questions more effectively.

Validity of Claims-Based Stroke Algorithms in Contemporary Medicare Data Reasons for Geographic and Racial Differences in Stroke (REGARDS) Study Linked With Medicare Claims

Background—The accuracy of stroke diagnosis in administrative claims for a contemporary population of Medicare enrollees has not been studied. We assessed the validity of diagnostic coding algorithms for identifying stroke in the Medicare population by linking data from the REasons for Geographic And Racial Differences in Stroke (REGARDS) Study to Medicare claims. Methods and Results—The REGARDS Study enrolled 30 239 participants ≥45 years in the United States between 2003 and 2007. Stroke experts adjudicated suspected strokes, using retrieved medical records. We linked data for participants enrolled in fee-for-service Medicare to claims files from 2003 through 2009. Using adjudicated strokes as the gold standard, we calculated accuracy measures for algorithms to identify incident and recurrent strokes. We linked data for 15 089 participants, among whom 422 participants had adjudicated strokes during follow-up. An algorithm using primary discharge diagnosis codes for acute ischemic or hemorrhagic stroke (International Classification of Diseases, Ninth Revision, Clinical Modification codes: 430, 431, 433.x1, 434.x1, 436) had a positive predictive value of 92.6% (95% confidence interval, 88.8%–96.4%), a specificity of 99.8% (99.6%–99.9%), and a sensitivity of 59.5% (53.8%–65.1%). An algorithm using only acute ischemic stroke codes (433.x1, 434.x1, 436) had a positive predictive value of 91.1% (95% confidence interval, 86.6%–95.5%), a specificity of 99.8% (99.7%–99.9%), and a sensitivity of 58.6% (52.4%–64.7%). Conclusions—Claims-based algorithms to identify stroke in a contemporary Medicare cohort had high positive predictive value and specificity, supporting their use as outcomes for etiologic and comparative effectiveness studies in similar populations. These inpatient algorithms are unsuitable for estimating stroke incidence because of low sensitivity.

Simplifying informed consent for biorepositories: Stakeholder perspectives

Purpose: Complex and sometimes controversial information must be conveyed during the consent process for participation in biorepositories, and studies suggest that consent documents in general are growing in length and complexity. As a first step toward creating a simplified biorepository consent form, we gathered data from multiple stakeholders about what information was most important for prospective participants to know when making a decision about taking part in a biorepository.Methods: We recruited 52 research participants, 12 researchers, and 20 institutional review board representatives from Durham and Kannapolis, NC. These subjects were asked to read a model biorepository consent form and highlight sentences they deemed most important.Results: On average, institutional review board representatives identified 72.3% of the sentences as important; researchers selected 53.0%, and participants 40.4% (P = 0.0004). Participants most often selected sentences about the kinds of individual research results that might be offered, privacy risks, and large-scale data sharing. Researchers highlighted sentences about the biorepositorys purpose, privacy protections, costs, and participant access to individual results. Institutional review board representatives highlighted sentences about collection of basic personal information, medical record access, and duration of storage.Conclusion: The differing mandates of these three groups can translate into widely divergent opinions about what information is important and appropriate to include a consent form. These differences could frustrate efforts to move simplified forms—for biobanking as well as for other kinds of research—into actual use, despite continued calls for such forms.

Has Public Reporting of Hospital Readmission Rates Affected Patient Outcomes?: Analysis of Medicare Claims Data.

BACKGROUND In 2009, the Centers for Medicare & Medicaid Services (CMS) began publicly reporting 30-day hospital readmission rates for patients discharged with acute myocardial infarction (MI), heart failure (HF), or pneumonia. OBJECTIVES This study assessed trends of 30-day readmission rates and post-discharge care since the implementation of CMS public reporting. METHODS We analyzed Medicare claims data from 2006 to 2012 for patients discharged after a hospitalization for MI, HF, or pneumonia. For each diagnosis, we estimated trends in 30-day all-cause readmissions and post-discharge care (emergency department visits and observation stays) by using hospitalization-level regression models. We modeled adjusted trends before and after the implementation of public reporting. To assess for a change in trend, we tested the difference between the slope before implementation and the slope after implementation. RESULTS We analyzed 37,829 hospitalizations for MI, 100,189 for HF, and 79,076 for pneumonia from >4,100 hospitals. When considering only recent trends (i.e., since 2009), we found improvements in adjusted readmission rates for MI (-2.3%), HF (-1.8%), and pneumonia (-2.0%), but when comparing the trend before public reporting with the trend after reporting, there was no difference for MI (p = 0.72), HF (p = 0.19), or pneumonia (p = 0.21). There were no changes in trends for 30-day post-discharge care for MI or pneumonia; however, the trend decreased for HF emergency department visits from 2.3% to -0.8% (p = 0.007) and for observation stays from 15.1% to 4.1% (p = 0.04). CONCLUSIONS The release of the CMS public reporting of hospital readmission rates was not associated with any measurable change in 30-day readmission trends for MI, HF, or pneumonia, but it was associated with less hospital-based acute care for HF.

Trends in 30-Day Readmission Rates for Patients Hospitalized With Heart Failure Findings From the Get With The Guidelines-Heart Failure Registry

Background—Reducing hospital readmissions for patients with heart failure is a national priority, and quality improvement campaigns are targeting reductions of ≥20%. However, there are limited data on whether such targets have been met. Methods and Results—We analyzed data from the American Heart Association’s Get With The Guidelines-Heart Failure registry linked to Medicare claims between 2009 and 2012 to describe trends and relative reduction of rates of 30-day all-cause readmission among patients with heart failure. A total of 21,264 patients with heart failure were included from 70 US sites from January 2009 to October 2012. Overall hospital-level, risk-adjusted, 30-day all-cause readmission rates declined slightly, from 20.0% (SD, 1.3%) in 2009 to 19.0% (SD, 1.2%) in 2012 (P=0.001). Only 1 in 70 (1.4%) hospitals achieved the 20% relative reduction in 30-day risk-adjusted readmission rates. A multivariable linear regression model was used to determine hospital-level factors associated with relative improvements in 30-day risk-adjusted readmissions between 2009 and 2012. Teaching hospitals had higher relative readmission rates as compared with their peers, and hospitals that used postdischarge heart failure disease management programs had lower relative readmission rates. Conclusions—Although there has been slight improvement in 30-day all-cause readmission rates during the past 4 years in patients with heart failure, few hospitals have seen large success.Background— Reducing hospital readmissions for patients with heart failure is a national priority, and quality improvement campaigns are targeting reductions of ≥20%. However, there are limited data on whether such targets have been met. Methods and Results— We analyzed data from the American Heart Association’s Get With The Guidelines-Heart Failure registry linked to Medicare claims between 2009 and 2012 to describe trends and relative reduction of rates of 30-day all-cause readmission among patients with heart failure. A total of 21,264 patients with heart failure were included from 70 US sites from January 2009 to October 2012. Overall hospital-level, risk-adjusted, 30-day all-cause readmission rates declined slightly, from 20.0% (SD, 1.3%) in 2009 to 19.0% (SD, 1.2%) in 2012 ( P =0.001). Only 1 in 70 (1.4%) hospitals achieved the 20% relative reduction in 30-day risk-adjusted readmission rates. A multivariable linear regression model was used to determine hospital-level factors associated with relative improvements in 30-day risk-adjusted readmissions between 2009 and 2012. Teaching hospitals had higher relative readmission rates as compared with their peers, and hospitals that used postdischarge heart failure disease management programs had lower relative readmission rates. Conclusions— Although there has been slight improvement in 30-day all-cause readmission rates during the past 4 years in patients with heart failure, few hospitals have seen large success.

Discharge heart rate and β-blocker dose in patients hospitalized with heart failure: Findings from the OPTIMIZE-HF registry

BACKGROUND Elevated heart rate of ≥70 beats/min despite β-blocker use may represent a new treatment target in patients in sinus rhythm with heart failure with reduced ejection fraction. However, little is known about the proportion of patients with elevated heart rate despite β-blocker therapy. METHODS We analyzed data from a large clinical registry to describe discharge heart rate as a function of β-blocker use and dose. We included patients with left ventricular ejection fraction <40% who were admitted with acute heart failure in 2003 and 2004; we excluded patients with a history of atrial arrhythmia or with a pacemaker or cardiac resynchronization therapy. We considered the β-blockers carvedilol, metoprolol succinate, bisoprolol, atenolol, and metoprolol tartrate and described discharge dose as a percentage of target dose (ie, <25%, 25%-49%, 50%-99%, and ≥100%). RESULTS Among 10,696 patients, median discharge heart rate was 76 beats/min (interquartile range [IQR] 66-86 beats/min). Of these, 7,826 (73%) were discharged on a β-blocker. For patients not on a β-blocker, median discharge heart rate was 80 beats/min (IQR 70-89 beats/min), compared with 78 beats/min (IQR 69-88 beats/min) on <25% of target dose, 75 beats/min (IQR 66-85 beats/min) on 25% to 49% of target dose, 74 beats/min (IQR 66-82 beats/min) on 50% to 99% of target dose, and 72 beats/min (IQR 65% to 80%) on 100% of target dose or greater (P < .001). Most patients, 7,647 (71%), had a discharge heart rate of ≥70 beats/min, including 1,460 (63%) of 2,301 patients discharged on 50% of target dose or greater. CONCLUSIONS Despite treatment with β-blockers, a substantial proportion of patients hospitalized with heart failure with reduced ejection fraction have elevated heart rate at discharge.

Databases in the Asia-pacific region: The potential for a distributed network approach

Background: This study describes the availability and characteristics of databases in Asian-Pacific countries and assesses the feasibility of a distributed network approach in the region. Methods: A web-based survey was conducted among investigators using healthcare databases in the Asia-Pacific countries. Potential survey participants were identified through the Asian Pharmacoepidemiology Network. Results: Investigators from a total of 11 databases participated in the survey. Database sources included four nationwide claims databases from Japan, South Korea, and Taiwan; two nationwide electronic health records from Hong Kong and Singapore; a regional electronic health record from western China; two electronic health records from Thailand; and cancer and stroke registries from Taiwan. Conclusions: We identified 11 databases with capabilities for distributed network approaches. Many country-specific coding systems and terminologies have been already converted to international coding systems. The harmonization of health expenditure data is a major obstacle for future investigations attempting to evaluate issues related to medical costs.

Oversight of Financial Conflicts of Interest in Commercially Sponsored Research in Academic and Nonacademic Settings

BACKGROUNDStudies of conflicts of interest in clinical research have focused on academic centers, but most clinical research takes place in nonacademic settings.OBJECTIVETo compare oversight and management of investigators’ financial relationships in academic and nonacademic research settings.DESIGN, SETTING, AND PARTICIPANTSSurvey of officials at 199 sites that contributed participants to commercially sponsored phase 3 clinical trials published in JAMA or the New England Journal of Medicine in 2006 and 2007.MEASUREMENTS AND MAIN RESULTSResponse rates were 66% for academic medical centers, 37% for nonacademic medical centers (inpatient), and 27% for outpatient nonacademic sites. Almost all academic medical centers (97%) and most nonacademic medical centers (87%) followed written conflict-of-interest policies, whereas 44% of outpatient nonacademic sites had written policies (P < 0.001). Academic and nonacademic medical centers relied mainly on internal institutional review boards (69% and 71%, respectively); outpatient nonacademic sites relied primarily on independent institutional review boards (59%; P < 0.001).CONCLUSIONSNonacademic sites have substantially different approaches to the oversight and management of financial relationships in commercially sponsored clinical research than academic medical centers. These differences warrant more attention to how financial relationships are monitored in community research settings.

Sex Differences in the Management and Outcomes of Heart Failure With Preserved Ejection Fraction in Patients Presenting to the Emergency Department With Acute Heart Failure.

BACKGROUND Heart failure (HF) with preserved ejection fraction (HFpEF) is more common in women than in men; data characterizing sex differences in the management and outcomes of HFpEF patients presenting to the emergency department (ED) are limited. METHODS AND RESULTS Using Acute Decompensated Heart Failure National Registry Emergency Module data linked to Medicare claims, we conducted a retrospective analysis of acute HF patients in the ED, identifying HFpEF (ejection fraction [EF] ≥40%) patients and stratifying by sex to compare baseline characteristics, ED therapies, hospital length of stay (LOS), in-hospital mortality, and post-discharge outcomes. Of 4161 HFpEF patients, 2808 (67%) were women, who were more likely to be older and hypertensive, but less likely to be diabetic or smokers (all P < .01). Women more often presented with systolic blood pressure >140 mm Hg (62.5% vs 56.4%; P = .0001) and higher EF. There were no sex differences in ED therapies, adjusted 30- and 180-day all-cause mortality, in-hospital mortality, or 30- and 180-day readmissions. After adjustment, women had longer LOS (0.40 days, 95% confidence interval [CI] 0.10-0.70; P = .008). CONCLUSIONS Women with HFpEF presenting to the ED were more likely to have elevated systolic blood pressure, but overall ED management strategies were similar to those in men. We observed adjusted differences in hospital LOS, but no differences in 30- and 180-day outcomes.

Relation of Elevated Heart Rate in Patients With Heart Failure With Reduced Ejection Fraction to One-Year Outcomes and Costs

There are limited data describing outcomes associated with an elevated heart rate in patients with heart failure with reduced ejection fraction (HFrEF) in routine clinical practice. We identified patients with HFrEF at Duke University Hospital undergoing echocardiograms and heart rate assessments without paced rhythms or atrial fibrillation. Outcomes (all-cause mortality or hospitalization and medical costs per day alive) were assessed using electronic medical records, hospital cost accounting data, and national death records. Patients were stratified by heart rate (<70 and ≥70 beats/min) and compared using generalized linear models specified with gamma error distributions and log links for costs and proportional hazard models for mortality/hospitalization. Of 722 eligible patients, 582 patients (81%) were treated with β blockers. The median heart rate was 81 beats/min (25th and 75th percentiles 69 to 96) and 527 patients (73%) had a heart rate ≥70 beats/min. After multivariate adjustment, a heart rate ≥70 beats/min was associated with increased 1-year all-cause mortality or hospitalization, hazard ratio 1.37 (95% CI 1.07 to 1.75) and increased medical costs per day alive, cost ratio 2.03 (95% CI 1.53 to 2.69). In conclusion, at a large tertiary care center, despite broad use of β blockers, a heart rate ≥70 beats/min was observed in 73% of patients with HFrEF and associated with worse 1-year outcomes and increased direct medical costs per day alive.