Publications

INTRODUCTION

Although traditional patient-centered medical homes (PCMHs) are effective for patients with complex needs, it is unclear whether homeless-tailored PCMHs work better for homeless veterans. We examined the impact of enrollment in a Veterans Health Administration (VHA) homeless-tailored PCMH on health services use, cost, and satisfaction compared with enrollment in a traditional, nontailored PCMH.

METHODS

We conducted a prospective, multicenter, quasi-experimental, single-blinded study at 2 VHA medical centers to assess health services use, cost, and satisfaction during 12 months among 2 groups of homeless veterans: 1) veterans receiving VHA homeless-tailored primary care (Homeless-Patient Aligned Care Team [H-PACT]) and 2) veterans receiving traditional primary care services (PACT). A cohort of 266 homeless veterans enrolled from June 2012 through January 2014.

RESULTS

Compared with PACT patients, H-PACT patients had more social work visits (4.6 vs 2.7 visits) and fewer emergency department (ED) visits for ambulatory care-sensitive conditions (0 vs 0.2 visits); a significantly smaller percentage of veterans in H-PACT were hospitalized (23.1% vs 35.4%) or had mental health-related ED visits (34.1% vs 47.6%). We found significant differences in primary care provider-specific visits (H-PACT, 5.1 vs PACT, 3.6 visits), mental health care visits (H-PACT, 8.8 vs PACT, 13.4 visits), 30-day prescription drug fills (H-PACT, 40.5 vs PACT, 58.8 fills), and use of group therapy (H-PACT, 40.1% vs PACT, 53.7%). Annual costs per patient were significantly higher in the PACT group than the H-PACT group ($37,415 vs $28,036). In logistic regression model of acute care use, assignment to the H-PACT model was protective as was rating health "good" or better.

CONCLUSION

Homeless veterans enrolled in the population-tailored primary care approach used less acute care and costs were lower. Tailored-care models have implications for care coordination in the US Department of Veterans Affairs VA and community health systems.

OBJECTIVES

To determine the relationship between manufacturer-related financial ties among investigators of published drug trials and rates of discrepant registered and published primary trial outcomes.

DESIGN

Cross-sectional study.

SETTING

Human subjects drug trials published in 'core clinical' MEDLINE journals in 2013.

PRIMARY AND SECONDARY OUTCOME MEASURES

The primary study endpoint was the presence of a prospectively registered, clearly defined primary outcome that matched the published primary outcome for each included trial. Secondary outcomes included assessments of registration timing and quality, and the impact of outcome discrepancies between registration and publication on the statistical significance of the included trials.

RESULTS

Of 192 included trials, 134 (70%) were positive and 58 (30%) were negative. Financial ties were present between first or last authors and drug manufacturers for 130 trials (68%), of which 78% were positive, versus 53% of trials with no financial ties that were positive. Clearly defined, prospectively registered outcomes that matched the published outcomes were present in just 76 of the 192 trials (40%). After adjusting for study start date and sample size, the observed relationship between investigator financial ties and the presence of a match between prospectively registered and published primary outcomes was of borderline statistical significance (OR 2.12, 95% CI 0.998 to 4.50). Studies with financial ties present were more likely than studies without ties to have been prospectively registered (78%vs48%, P<0.001) and were more likely to have prospectively registered a clearly defined primary outcome(62%vs35%, P<0.001).

CONCLUSIONS

Less than half of the trials in this cohort were prospectively registered with a clear primary outcome that was consistent with the primary outcome reported in the published manuscript. The presence of investigator financial ties was associated with higher quality registration practices, though this association diminished after adjusting for factors that impact registration quality.

HIV-positive individuals are at increased risk for kidney disease, including HIV-associated nephropathy, noncollapsing focal segmental glomerulosclerosis, immune-complex kidney disease, and comorbid kidney disease, as well as kidney injury resulting from prolonged exposure to antiretroviral therapy or from opportunistic infections. Clinical guidelines for kidney disease prevention and treatment in HIV-positive individuals are largely extrapolated from studies in the general population, and do not fully incorporate existing knowledge of the unique HIV-related pathways and genetic factors that contribute to the risk of kidney disease in this population. We convened an international panel of experts in nephrology, renal pathology, and infectious diseases to define the pathology of kidney disease in the setting of HIV infection; describe the role of genetics in the natural history, diagnosis, and treatment of kidney disease in HIV-positive individuals; characterize the renal risk-benefit of antiretroviral therapy for HIV treatment and prevention; and define best practices for the prevention and management of kidney disease in HIV-positive individuals.

BACKGROUND

HIV preexposure prophylaxis (PrEP) using daily oral tenofovir-disoproxil-fumarate/emtricitabine (TDF/FTC) is effective for preventing HIV acquisition, but concerns remain about its potential kidney toxicity. This study examined kidney function in individuals using PrEP in real-world clinical settings.

SETTING

Demonstration project in 2 sexually transmitted infection clinics and a community health center.

METHODS

We evaluated kidney function among men who have sex with men and transgender women taking tenofovir-disoproxil-fumarate/emtricitabine PrEP for up to 48 weeks. Serum creatinine and urine dipstick for protein were obtained at 12-week intervals. Kidney function was estimated using creatinine clearance (CrCl) (Cockcroft-Gault) and estimated glomerular filtration rate (eGFR) (CKD-EPI).

RESULTS

From October 2012 to January 2014, we enrolled 557 participants (median age 33). Mean creatinine increased from baseline to week 12 by 0.03 mg/dL (4.6%) (P < 0.0001); mean CrCl decreased by 4.8 mL/min (3.0%) (P < 0.0001). These changes remained stable through week 48 (P = 0.81, P = 0.71 respectively). There were 75/478 (15.7%) participants who developed worsening proteinuria at week 12 compared with baseline (P < 0.0001), and this percent remained stable through week 48 (P = 0.73). Twenty-five participants (5.1%) developed new-onset eGFR <70 mL/min/1.73 m; independent predictors of this outcome were age ≥40 years (OR 3.79, 95% CI: 1.43 to 10.03) and baseline eGFR <90 mL/min/1.73 m (OR 9.59, 3.69-24.94).

CONCLUSIONS

In a demonstration setting, daily tenofovir-disoproxil-fumarate/emtricitabine PrEP leads to reduced CrCl and eGFR; however, these eGFR changes are based on very small changes in serum creatinine and seem to be nonprogressive after the first 12 weeks. Future studies are needed to understand the prognostic significance of these small changes.