Launching PCORnet, a national patient-centered clinical research network

The Patient-Centered Outcomes Research Institute (PCORI) has launched PCORnet, a major initiative to support an effective, sustainable national research infrastructure that will advance the use of electronic health data in comparative effectiveness research (CER) and other types of research. In December 2013, PCORI's board of governors funded 11 clinical data research networks (CDRNs) and 18 patient-powered research networks (PPRNs) for a period of 18 months. CDRNs are based on the electronic health records and other electronic sources of very large populations receiving healthcare within integrated or networked delivery systems. PPRNs are built primarily by communities of motivated patients, forming partnerships with researchers. These patients intend to participate in clinical research, by generating questions, sharing data, volunteering for interventional trials, and interpreting and disseminating results. Rapidly building a new national resource to facilitate a large-scale, patient-centered CER is associated with a number of technical, regulatory, and organizational challenges, which are described here

Does the Funding Source Influence the Results in Economic Evaluations?: A Case Study in Bisphosphonates for the Treatment of Osteoporosis

Background: Research sponsored by the pharmaceutical industry is often assumed to be more likely to report favourable cost-effectiveness results. Objective: To determine whether there was a relationship between the source of funding and the reporting of positive results. Methods: We conducted a systematic review of the literature to identify economic evaluations of bisphosphonates for the treatment of osteoporosis. We extracted the source of funding, region of study, the journal name and impact factor, and all reported incremental cost-effectiveness ratios (ICERs). We identified which ICERs were under the thresholds of &dollar;US20 000, &dollar;US50 000 and &dollar;US100 000 per QALY. A quality score between 0 and 7 was also given to each of the studies. We used generalized estimating equations for the analysis. Results: The systematic review yielded 532 potential abstracts; 17 of these met our final eligibility criteria. Ten studies (59%) were funded by non-industry sources. A total of 571 ICERs were analysed. There was no significant difference between the number of industry- and non-industry-funded studies reporting ICERs below the thresholds of &dollar;US20 000 and &dollar;US50 000. However, industry-sponsored studies were more likely to report ICERs below &dollar;US100 000 (odds ratio - 4.69, 95% CI 1.77, 12.43). Studies of higher methodological quality (scoring >4.5 of 7) were less likely to report ICERs below &dollar;US20 000 and &dollar;US50 000 than studies of lower methodological quality (scores <4). Methodological quality was not significantly different between studies reporting ICERs under &dollar;US100 000. Conclusions: In this relatively small sample of studies of bisphosphonates, the funding source (industry vs non-industry) did not seem to significantly affect the reporting of ICERs below the &dollar;US20 000 and &dollar;US50 000 thresholds. We hypothesize that methodological quality might be a more significant factor than the source of funding in differentiating which studies are likely to report favourable ICERs, with the higher-quality studies significantly less likely to report ICERs below &dollar;US20 000 and &dollar;US50 000 per QALY. Further research should explore this finding.Bisphosphonates, therapeutic use, Cost-utility, Osteoporosis, treatment

Economic Outcomes Associated With Atypical Antipsychotics in Bipolar Disorder: A Systematic Review

Objective: Bipolar disorder is a serious condition that is costly to the health care system. Atypical antipsychotics are more expensive than conventional treatments. From a policy-making perspective, the additional cost must be justified by improved outcomes. The objective of this study was to conduct a systematic review to determine the relative costs and cost-effectiveness associated with atypical antipsychotics in bipolar disorder

The critical role of observational evidence in comparative effectiveness research

Although not the gold standard of clinical research, observational studies can play a central role as the nation’s health care system embraces comparative effectiveness research. Investigators generally prefer randomized trials to observational studies because the former are less subject to bias. Randomized studies, however, often don’t represent real-world patient populations, while observational studies can offer quicker results and the opportunity to investigate large numbers of interventions and outcomes among diverse populations—sometimes at lower costs. But some decisions based on observational studies have turned out to be wrong. We recommend that researchers adopt a “body of evidence” approach that includes both randomized and observational evidence