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Schnitzler M.A.,Saint Louis University | Johnston K.,Oxford Outcomes | Axelrod D.,Dartmouth Hitchcock Medical Center | Gheorghian A.,Saint Louis University | Lentine K.L.,Saint Louis University
Transplantation | Year: 2011

Background. Improved early kidney transplant outcomes limit the contemporary utility of standard clinical endpoints. Quantifying the relationship of renal function at 1 year after transplant with subsequent clinical outcomes and healthcare costs may facilitate cost-benefit evaluations among transplant recipients. Methods. Data for Medicare-insured kidney-only transplant recipients (1995-2003) were drawn from the United States Renal Data System. Associations of estimated glomerular filtration rate (eGFR) level at the first transplant anniversary with subsequent death-censored graft failure and patient death in posttransplant years 1 to 3 and 4 to 7 were examined by parametric survival analysis. Associations of eGFR with total health care costs defined by Medicare payments were assessed with multivariate linear regression. Results. Among 38,015 participants, first anniversary eGFR level demonstrated graded associations with subsequent outcomes. Compared with patients with 12-month eGFR more than or equal to 60 mL/min/1.73 m, the adjusted relative risk of death-censored graft failure in years 1 to 3 was 31% greater for eGFR 45 to 59 mL/min/1.73 m (P<0.0001) and 622% greater for eGFR 15 to 30 mL/min/1.73 m (P<0.0001). Associations of first anniversary eGFR level with graft failure and mortality remained significant in years 4 to 7. The proportions of recipients expected to return to dialysis or die attributable to eGFR less than 60 mL/min/1.73 m over 10 years were 23.1% and 9.4%, respectively, and were significantly higher than proportions attributable to delayed graft function or acute rejection. Reduced eGFR was associated with graded and significant increases in health care spending during years 2 and 3 after transplant (P<0.0001). Conclusion. eGFR is strongly associated with clinical and economic outcomes after kidney transplantation. Copyright © 2011 by Lippincott Williams & Wilkins.

Peters M.,University of Oxford | Crocker H.,University of Oxford | Jenkinson C.,University of Oxford | Doll H.,Oxford Outcomes | Fitzpatrick R.,University of Oxford
BMJ Open | Year: 2014

Objectives: To evaluate the feasibility of using patient-reported outcome measures (PROMs) for longterm conditions (LTCs) in primary care. Design: A cohort postal survey conducted from September 2010 to April 2012. Setting: Primary care practices (n=33) in London and the North-West of England. Participants: 4484 patients with a diagnosis of asthma, chronic obstructive pulmonary disease, diabetes, epilepsy, heart failure or stroke were sent a survey at baseline. Main outcome: The main outcome was to evaluate the feasibility of and the recruitment strategies for collecting PROMs data in LTCs by assessing the response rates for the baseline and follow-up surveys. Secondary outcomes were the evaluation of change scores of the EQ-5D index and visual analogue scale (VAS) between baseline and follow-up surveys. Results: The baseline survey achieved a response rate of 38.4% (n=1721/4485) and at follow-up 71.5% (n=1136/1589). Response rates varied by LTC. Little change was found in health-related quality of life for the total sample (-0.001 for the EQ-5D index score and 0.12 for the EQ-5D VAS) between patients responding to both the baseline and follow-up surveys. Conclusions: The response rate to the baseline survey was similar to that of other general practice surveys. Current UK policy aims to assess health service performance in LTCs by means of using PROMs. It thus would be desirable to improve response rates by making the invitation to self-reports of health-related quality of life more engaging for patients. Results on the EQ-5D score raise questions about optimal indicators for LTCs and appropriate timelines for assessment.

Shingler S.,Oxford Outcomes
The Cochrane database of systematic reviews | Year: 2013

Compression hosiery or stockings are often the first line of treatment for varicose veins in people without either healed or active venous ulceration. Evidence is required to determine whether the use of compression stockings can effectively manage and treat varicose veins in the early stages. This is an update of a review first published in 2011. To assess the effectiveness of compression stockings for the only and initial treatment of varicose veins in patients without healed or active venous ulceration. For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched August 2013) and CENTRAL (2013, Issue 5). Randomised controlled trials (RCTs) were included if they involved participants diagnosed with primary trunk varicose veins without healed or active venous ulceration (Clinical, Etiology, Anatomy, Pathophysiology (CEAP) classification C2 to C4). Included trials assessed compression stockings versus no treatment, compression versus placebo stockings, or compression stockings plus drug intervention versus drug intervention alone. Trials comparing different lengths and pressures of stockings were also included. Trials involving other types of treatment for varicose veins (either as a comparator to stockings or as an initial non-randomised treatment), including sclerotherapy and surgery, were excluded. Two authors assessed the trials for inclusion and quality (SS and LR). SS extracted the data, which were checked by LR. Attempts were made to contact trial authors where missing or unclear data were present. Seven studies involving 356 participants with varicose veins without healed or active venous ulceration were included. Different levels of pressure were exerted by the stockings in the studies, ranging from 10 to 50 mmHg. One study assessed compression hosiery versus no compression hosiery. The other six compared different types or pressures of stockings. The methodological quality of all included trials was unclear, mainly because of inadequate reporting.The symptoms subjectively improved with the wearing of stockings across trials that assessed this outcome, but these assessments were not made by comparing one randomised arm of a trial with a control arm and are therefore subject to bias.Meta-analyses were not undertaken due to inadequate reporting and actual or suspected high levels of heterogeneity. There is insufficient, high quality evidence to determine whether or not compression stockings are effective as the sole and initial treatment of varicose veins in people without healed or active venous ulceration, or whether any type of stocking is superior to any other type. Future research should consist of a large RCT of participants with trunk varices either wearing or not wearing compression stockings to assess the efficacy of this intervention. If compression stockings are found to be beneficial, further studies assessing which length and pressure is the most efficacious could then take place.

Anderson R.T.,Penn State College of Medicine | Linnehan J.E.,Oxford Outcomes | Keating K.,Bayer AG | Wirth L.J.,Harvard University
Thyroid | Year: 2013

Background: Thyroid cancer is the most common endocrine malignancy, with differentiated thyroid cancer (DTC) comprising ∼93% of all thyroid cancers. While most cases of DTC are curable with the use of surgery and radioactive iodine (RAI) ablation of the remaining thyroid remnant, prognosis is dire and treatment options limited when DTC becomes RAI-refractory (RAI-R). Standard cytotoxic chemotherapy has limited efficacy, making enrollment in clinical trials of novel targeted therapies the preferred treatment approach. Thus, we conducted a comprehensive systematic review of the clinical trial scientific literature with a focus on efficacy, safety, and economics to identify all potential treatment options that have been or are currently being evaluated for the treatment of RAI-R DTC. Methods: Embase.com (including Medline), Medline In-Process and other nonindexed citations, the Cochrane Libraries, ClinicalTrials.gov, and relevant recent conference proceedings were searched using predefined search criteria. Important inclusion criteria included English language, randomized controlled studies or interventional single-Arm studies only, and studies of drug therapies only. Search results were screened utilizing the discretion of multiple researchers, and key data were abstracted. Results: Forty-five unique trials (16 full-text, 4 conference abstracts, and 25 ClinicalTrials.gov entries) were included in the clinical review. No studies that met criteria for inclusion in the economic review were identified. Among 20 trials with results available, all were Phase II and only one was randomized. The most commonly studied drugs were tyrosine kinase inhibitors (TKIs); other drugs included celecoxib, doxorubicin with interferon alpha-2b, rosiglitazone, selumetinib (AZD6244), thalidomide, VEGF trap, and vorinostat. Overall, efficacy and safety profiles were specific to treatment regimen, with objective response rates (ORR) ranging from 0% on gefitinib, rosiglitazone, VEGF trap, and vorinostat to 50% on lenvatinib, a TKI. Conclusions: Limited clinical research and no economic research has been conducted in RAI-R DTC. Certain treatments, notably TKIs, have shown promise in Phase II trials, and two Phase III randomized placebo-controlled trials are ongoing. New research on the economic and humanistic burden of RAI-R DTC must be paired with the clinical evidence currently in development to examine the existing burden and future promise in treating patients with RAI-R DTC. © Copyright 2013, Mary Ann Liebert, Inc. 2013.

Dewilde S.,Services in Health Economics | Hawkins N.,Oxford Outcomes
Journal of Clinical Epidemiology | Year: 2012

Objective: To identify confounding factors that may explain the incoherence between direct and indirect evidence in a published analysis comparing extended-release dipyridamole (ERDP) plus aspirin to clopidogrel for the reduction of stroke. Study Design and Setting: An existing analysis was updated with new studies from a systematic literature review. Clinicians reviewed the studies for potential confounders. Network meta-analyses were conducted including or excluding potential confounders, and were estimated based on direct, indirect, or a combination of direct and indirect evidence. Model fit was compared using the residual deviance and the deviance information criterion (DIC); node splitting was used to test for incoherence between the networks. Results: Six trials and one meta-analysis were identified; aspirin dosage was identified as a potential confounder. The odds ratio (OR) for stroke of aspirin plus ERDP vs. clopidogrel based on indirect evidence without aspirin dosage adjustment is 0.85 (0.68-1.05); when accounting for the aspirin dose-response relationship it is 0.96 (0.73-1.25); and the direct evidence based on PRoFESS resulted in an OR of 1.02 (0.93-1.12). Conclusion: When analyzing networks of evidence, attention should be paid to identifying and adjusting for potentially confounding factors. Investigating rather than ignoring inconsistency in the data set leads to clearer insight into relative efficacy. © 2012 Elsevier Inc. All rights reserved.

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