Interstitial lung disease and risk of mortality: 11-year nationwide population-based study.

BACKGROUND: Patients with interstitial lung disease (ILD) constitute a substantial disease burden. Although ILD outcomes have been investigated, the risk of death due to ILD has not been studied in the light of confounders and comorbidities. In this nationwide, 11-year longitudinal, population-based study, we aimed to discover if ILD is an independent risk factor for mortality. DESIGN: Data on 1 031 392 (2.2%) randomly selected subjects from 47 279 373 Korean residents were collected from the 2002 Korean National Health Insurance database. The ILD group comprised patients with an initial diagnosis of ILD between January 2003 and December 2007. Each patient was followed until 2013. We used Cox proportional hazard regression analyses to calculate the risk of death adjusted for comorbidities and confounders. RESULTS: ILD developed in 783 of the 303 385 subjects during the 5-year period (51 per 100 000 person-years). Death occurred in 157 (23.2%) cases and 272 controls (10.4%). ILD was significantly associated with the risk of death (hazard ratio 2.1, 95% confidence interval [CI] 1.6-2.7) and for those aged 40-59, 60-69 and 70 years. A high proportion of patients with ILD died due to respiratory causes. CONCLUSION: ILD patients had a significantly higher risk of death than matched controls, after adjustment for potential confounders and comorbidities.

Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making.

Analyses of healthcare databases (claims, electronic health records [EHRs]) are useful supplements to clinical trials for generating evidence on the effectiveness, harm, use, and value of medical products in routine care. A constant stream of data from the routine operation of modern healthcare systems, which can be analyzed in rapid cycles, enables incremental evidence development to support accelerated and appropriate access to innovative medicines. Evidentiary needs by regulators, Health Technology Assessment, payers, clinicians, and patients after marketing authorization comprise (1) monitoring of medication performance in routine care, including the materialized effectiveness, harm, and value; (2) identifying new patient strata with added value or unacceptable harms; and (3) monitoring targeted utilization. Adaptive biomedical innovation (ABI) with rapid cycle database analytics is successfully enabled if evidence is meaningful, valid, expedited, and transparent. These principles will bring rigor and credibility to current efforts to increase research efficiency while upholding evidentiary standards required for effective decision-making in healthcare.

Construction of the Korea Elderly Pharmacoepidemiologic Cohort: drug utilization review of cephalosporins in geriatric inpatients.

We performed a cohort-based pharmacoepidemiologic study in order to evaluate the pattern of cephalosporin prescriptions in elderly inpatients in Korea. The Korea Elderly Pharmacoepidemiologic Cohort was composed of a geriatric population of beneficiaries of the Korea Medical Insurance Corporation residing in Busan in 1993. The cohort consisted of 23,649 members, comprising 15,221 women (64.4%) and 8428 men (35.6%). The study population for drug utilization review consisted of those cohort members who were admitted into hospitals during the period January 1993 through December 1994. The number of hospitalized patients was 4262, comprising 2631 women (61.7%) and 1681 men (38.3%). The trend of cephalosporin prescriptions over the 2-year period showed that the use of second and third generation cephalosporins increased relative to the use of first generation. The use of cephalosporins combined with other antibiotics was found to occur in 22.8% aminoglycosides (76.7%) and quinolones (17.1%) being the most common antibiotics combined with cephalosporins. Our result demonstrates an increase in the prescription of second and third generation cephalosporins in Korea, which has implications not only for the elderly population but also for the total population because of the impact on health care costs and the potential for the emergence of antimicrobial resistance.