Comparing Patient-Reported Outcomes Among Anti-TNF Experienced Patients With Ulcerative Colitis Initiating Vedolizumab Versus Tofacitinib.

Background: Primary and secondary nonresponse to anti-tumor necrosis factor (TNF) therapy is common in patients with ulcerative colitis (UC), yet limited research has compared the effectiveness of subsequent biological therapy. Objective: We sought to compare the effectiveness of vedolizumab and tofacitinib in anti-TNF experienced patients with UC, focusing on patient-prioritized patient-reported outcomes (PROs). Methods: We conducted a prospective cohort study nested within the Crohn's & Colitis Foundation's IBD Partners and SPARC IBD initiatives. We identified anti-TNF experienced patients with UC initiating vedolizumab or tofacitinib and analyzed PROs reported approximately 6 months later (minimum 4 months, maximum 10 months). Co-primary outcomes were Patient Reported Outcome Measurement Information System (PROMIS) domains of Fatigue and Pain Interference. Secondary outcomes included PRO2, treatment persistence, and need for colectomy. Results: We compared 72 vedolizumab initiators and 33 tofacitinib initiators. At follow-up, Pain Interference (P = .04), but not Fatigue (P = .53) was lower among tofacitinib initiators. A trend toward higher Social Role Satisfaction was not significant. The remainder of secondary outcomes (PRO2, treatment persistence, colectomy) did not differ between treatment groups. Conclusions: Among anti-TNF experienced patients with UC, Pain Interference 4-10 months after treatment initiation was lower among tofacitinib users as compared with vedolizumab users. Many, but not all, secondary endpoints and subanalyses also favored tofacitinib. Future studies with larger sample sizes are needed to further evaluate these findings.

The Patient-Centered Outcomes Research Network Antibiotics and Childhood Growth Study: Implementing Patient Data Linkage.

PCORnet, the Patient-Centered Outcomes Research Network, is comprised of health systems and health plans that transform electronic health records (EHRs) and claims data to a common data model (CDM) to facilitate real-world clinical research. Because patients receive health care in multiple care delivery settings, linking health records across systems and health plan claims would provide a more comprehensive and accurate picture of health care for patients. The current study expanded on a PCORnet Antibiotics and Childhood Growth (ABX) study to (1) identify and implement a privacy-preserving patient linkage solution among a clinical data research network and a health plan network within the ABX Study, and (2) assess overlap in prescribed and dispensed antibiotics and additional data gained from claims among the linked patients. This manuscript describes the linkage process and resulting overlap analysis. The authors identified 549 patients from the EHR record study cohort who had claims records with the health plan. Sixty percent (n = 329) of patients had consistent antibiotic exposure data across the 2 sources, indicating antibiotic exposure (44.3%) or nonexposure (15.7%). Among total antibiotic prescribing records, 43.1% had a matched claims record for dispensing within 60 days. Among antibiotic dispense records 26.5% were not associated with a prescribing record in the linked health systems. These findings showcase the feasibility of linking health plan claims data to PCORnet CDM in a privacy-preserving manner while also demonstrating continued gaps in data that may occur. The study highlights the importance of combining multiple health data sources for comprehensive clinical research.

Iatrogenic disease management: moderating medication errors and risks in a pharmacy benefit management environment.

Disease Management (DM) programs have advanced to address costly chronic disease patterns in populations. This is in part due to the programs' significant clinical and economical value, coupled with interest by pharmaceutical manufacturers, managed care organizations, and pharmacy benefit management firms. While cost containment realizations for many such interventions have been less than anticipated, this article explores potentials in marrying Medication Error Risk Reduction into DM programs within managed care environments. Medication errors are an emergent serious problem now gaining attention in US health policy. They represent a failure within population-based health programs because they remain significant cost drivers. Therefore, medication errors should be addressed in an organized fashion, with DM being a worthy candidate for piggybacking such programs to achieve the best synergistic effects.

Impact of a migraine management program on improving health outcomes.

The goals of this program were to evaluate the effectiveness of migraine disease management techniques in improving patient satisfaction with migraine care, decreasing the frequency and severity of headaches and migraine-associated disability, increasing the effectiveness of migraine treatment and work productivity, improving physician diagnosis and treatment of migraine, and ultimately determining the program's impact on healthcare resource utilization. A prospective observational study was undertaken. This prospective Migraine Management Program (MMP) used active patient and healthcare physician-based disease management resources, tools, and techniques. Members were identified using administrative and medical claims databases indicating an ICD-9 diagnosis code (346.XX) for migraine during the previous twelve months. All identified patients received the Migraine Therapy Assessment Questionnaire (MTAQ) to assess their level of migraine control for pre/post measurement. Of the 2,134 patients responding to the initial MTAQ, 789 completed both a baseline and follow-up and 1,345 completed only a baseline questionnaire. For those patients completing both, there was a statistically significant reduction in all identified management issues: poor symptom control, high attack frequency, knowledge/behavior barriers, economic burden, and dissatisfaction with treatment. Comparing the former group to those completing only the baseline MTAQ, the latter were significantly more likely to report problems with three migraine management issues; poorer symptom control, greater economic burden, and dissatisfaction with their treatment. The use of appropriate patient and physician educational interventions, such as Aetna's MMP incorporating disease management principles and the MTAQ questionnaire, can have a significant impact on patient-centered outcomes and satisfaction with their migraine treatment.

Clinical and economic outcomes in thrombolytic treatment of peripheral arterial occlusive disease and deep venous thrombosis.

PURPOSE: Over the past 2 decades the use of thrombolytic therapy in the management of peripheral occlusive diseases, most notably peripheral arterial occlusion (PAO) and deep venous thrombosis (DVT), has become an accepted and potentially preferable alternative to surgery. We examined the period when urokinase was in short supply and subsequently unavailable, to explore potential differences in clinical outcome and economic effect between urokinase and recombinant tissue plasminogen activator (rt-PA). MATERIAL AND METHODS: Data were obtained from the Premier Perspective Database, a broad clinical database that contains information on inpatient medical practices and resource use. The study population included all patients hospitalized in 1999 and 2000 with a primary or secondary diagnosis of PAO or DVT. Incidence was calculated for common adverse events, including bleeding complications, intracranial hemorrhage, amputation, and death. Cost data were also abstracted from the database, and are expressed as mean +/- SD. RESULTS: Demographic variables were similar in the urokinase and rt-PA groups. The rate of bleeding complications was similar in the urokinase and rt-PA groups. There were no intracranial hemorrhages in the urokinase group, compared with a rate of 1.5% in the rt-PA PAO group (P = .087) and 1.9% in the rt-PA DVT group (P = .175). The in-hospital mortality rate was lower in the urokinase-treated PAO subgroup (3.6% vs 8.5%; P = .026), but a similar finding in the DVT subgroup did not achieve statistical significance (4% vs 9.8%; P = .069). While pharmacy costs were greater in the urokinase-treated group (US 5472 dollars +/- US 5579 dollars vs US 3644 dollars +/- US 6009 dollars, P < .001; PAO subgroup, US 11,070 dollars +/- US 15,409 dollars vs US 6150 dollars +/- US 12,398 dollars, P = .003), overall hospital costs did not differ significantly between the 2 groups. This finding appears to be explained by a shorter hospital stay and reduced room and board costs in the urokinase-treated group. CONCLUSION: There were significant differences in outcome in patients with PAO and DVT who received treatment with urokinase and rt-PA. While pharmacy costs were significantly greater when urokinase was used, reduction in length of stay accounted for similar total hospital costs compared with rt-PA. These findings must be considered in the context of the retrospective nature of the analysis and the potential to use dosing regimens that differ from those in this study.

An ongoing six-year innovative osteoporosis disease management program: challenges and success in an IPA physician group environment.

The goal of this ongoing comprehensive osteoporosis disease management initiative is to provide the adult primary care physicians' (PCPs) offices with a program enabling them to systematically identify and manage their population for osteoporosis. For over six years, Hill Physicians Medical Group (Hill Physicians) has implemented multiple strategies to develop a best practice for identifying and treating members who were candidates for osteoporosis therapy. Numerous tools were used to support this disease management effort, including: evidence-based clinical practice guidelines, patient education sessions, the Simple Calculated Osteoporosis Risk Estimation (SCORE) questionnaire tool, member specific reports for PCPs, targeted member mailings, office-based Peripheral Instantaneous X-ray Imaging (PIXI) test and counseling, dual x-ray absorptiometry (DEXA) scan guidelines, and web-based Electronic Simple Calculated Osteoporosis Risk Estimation (eSCORE) questionnaire tools. Hill Physicians tabulated results for patients who completed 2649 SCORE tests, screened 978 patients with PIXI tests, and identified 338 osteopenic and 124 osteoporotic patients. The preliminary results of this unique six-year ongoing educational initiative are slow but promising. New physician offices express interest in participating and those offices that have participated in the program continue to screen for osteoporosis. Hill Physicians' message is consistent and is communicated to the physicians repeatedly in different ways in accordance with the principles of educational outreach. Physicians who have conducted the program have positive feedback from their patients and office staff and have begun to communicate their experience to their peers.

Epidural steroids, epidural morphine and epidural steroids combined with morphine in the treatment of post-laminectomy syndrome.

Epidural morphine injection followed by a steroid has been reported to be effective for the post-laminectomy pain ('failed back') syndrome. This double-blind, parallel study was undertaken to evaluate that mode of therapy. Twenty-two patients who had undergone at least one prior laminectomy, who were still symptomatic, were randomized to receive 50 mg of lidocaine epidurally with: (a) 75 mg triamcinolone diacetate (TR); or (b) 8 mg of preservative-free morphine (MP); or (c) both (TR and MP), at 1 month intervals for 3 consecutive months. The spinal interspace identified with the patients' pain complaint was the site of injection. For each treatment, patients were admitted to the Clinical Research Center for 24 h and their condition continuously monitored with a pulse oximeter and apnea monitor. Five to 7 patients in each group had pain relief for less than 1 month. No patient given morphine had pain relief for more than 1 month. Life-threatening ventilatory depression occurred in the group given triamcinolone and morphine. The use of morphine alone or combined with slow release triamcinolone does not appear to be appropriate for the treatment of the post-laminectomy pain syndrome.