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Wolowacz S.,Health Economics | Pearson I.,Health Economics | Shannon P.,Patient Reported Outcomes | Chubb B.,Novo Nordisk AS | And 3 more authors.
Diabetic Medicine | Year: 2015

Aims: To develop a health economic model to evaluate the cost-effectiveness of new interventions for Type 1 diabetes mellitus by their effects on long-term complications (measured through mean HbA1c) while capturing the impact of treatment on hypoglycaemic events. Methods: Through a systematic review, we identified complications associated with Type 1 diabetes mellitus and data describing the long-term incidence of these complications. An individual patient simulation model was developed and included the following complications: cardiovascular disease, peripheral neuropathy, microalbuminuria, end-stage renal disease, proliferative retinopathy, ketoacidosis, cataract, hypoglycemia and adverse birth outcomes. Risk equations were developed from published cumulative incidence data and hazard ratios for the effect of HbA1c, age and duration of diabetes. We validated the model by comparing model predictions with observed outcomes from studies used to build the model (internal validation) and from other published data (external validation). We performed illustrative analyses for typical patient cohorts and a hypothetical intervention. Results: Model predictions were within 2% of expected values in the internal validation and within 8% of observed values in the external validation (percentages represent absolute differences in the cumulative incidence). Conclusions: The model utilized high-quality, recent data specific to people with Type 1 diabetes mellitus. In the model validation, results deviated less than 8% from expected values. What's new?: A simple cost-utility model was developed to evaluate new interventions for Type 1 diabetes mellitus by assessing the association between the interventions' effects on mean HbA1c and long-term complications and the risk of hypoglycaemic events. High-quality, recently reported data specific to people with Type 1 diabetes mellitus were identified by a systematic review. Model validation included review by clinical and economic experts, verification of input data and formulae, and comparison of model predictions with observations from studies used to build the model and other published data. © 2015 Diabetes UK.

Finkelstein E.A.,National University of Singapore | Allaire B.T.,Rti International | Dibonaventura M.D.,Health Economics and Outcomes Research | Burgess S.M.,Patient Reported Outcomes
Journal of Occupational and Environmental Medicine | Year: 2011

Objective: To estimate the time to breakeven and 5-year net costs for laparoscopic adjustable gastric banding among obese patients with diabetes taking direct and indirect costs into account. Methods: Indirect cost savings were generated by quantifying the cross-sectional relationship between medical expenditures and absenteeism and between medical expenditures and presenteeism (reduced on-the-job productivity) and simulating indirect cost savings based on these multipliers and reductions in direct medical costs available in the literature. Results: Time to breakeven was estimated to be nine quarters with and without the inclusion of indirect costs. After 5 years, net savings increase from $26570 (±$9000) to $34160 (±$ 10380) when indirect costs are included. Conclusion: This study presented a novel approach for incorporating indirect costs into cost-benefit analyses. Application to gastric banding revealed that inclusion of indirect costs improves the financial outlook for the procedure. © 2011 by American College of Occupational and Environmental Medicine.

Fleming S.,Patient Reported Outcomes | Barsdorf A.I.,Pfizer | Howry C.,Product Strategy and Innovation | O'Gorman H.,Exco InTouch | Coons S.J.,Critical Path Institute
Therapeutic Innovation and Regulatory Science | Year: 2015

For a number of compelling scientific, operational, and regulatory reasons, the use of electronic data capture is becoming the preferred means of collecting clinical outcome assessment (eg, patient-reported outcome [PRO]) data in clinical trials. Electronic PRO (ePRO) data collection leverages screen-based technologies (eg, handheld devices, tablet computers, and web-based systems) and telephone-based (eg, interactive voice response) systems. Data collection is routinely either site based (ie, clinical study site) or field based (eg, subject’s home, school, or workplace). While tablet computers are often used for site-based PRO data collection, handheld devices have become the mainstay for ePRO data capture in field-based settings. The data collection devices are usually provisioned to the sites or subjects by an ePRO system provider contracted by the clinical trial sponsor. With site-based data collection, study staff are responsible for ensuring subject compliance with the protocol-driven data collection procedures, whereas with field-based data collection, the subject is responsible for compliance with the data entry requirements and sites are accountable for remotely monitoring the data for compliance. In addition to site and subject compliance issues, technology-related factors must be anticipated in order to adhere to the electronic PRO data collection plan. The objective of this paper is to describe study site-, subject-, and technology-related factors that may lead to deviations from the planned electronic collection of PRO data (eg, defaulting to paper-based data collection) and to provide recommendations aimed at preventing potential problems or quickly resolving problems once they occur. © 2015, © The Author(s) 2015.

Gater A.,Patient Reported Outcomes | Heron L.,Value Insight and Communication | Abetz-Webb L.,Patient Reported Outcomes | Coombs J.,Novartis | And 3 more authors.
Leukemia Research | Year: 2012

Ensuring adherence to therapy is a challenge in chronic diseases, particularly in cancers such as chronic myeloid leukemia (CML), where there has been increased availability and use of oral formulations. A conceptual model of adherence was developed based on findings from a comprehensive literature review, to inform strategies for improving adherence to oral CML therapies. A complex interplay of factors (including clinical, psychological and behavioural) influence adherence to such therapies. Healthcare professionals have a key role in promoting and facilitating adherence and future strategies should place greater emphasis on understanding patient-level experiences in order to create personalized solutions. © 2012 Elsevier Ltd.

Demuro C.,Patient Reported Outcomes | Clark M.,Patient Reported Outcomes | Doward L.,Patient Reported Outcomes | Evans E.,Patient Reported Outcomes | And 2 more authors.
Value in Health | Year: 2013

Background The US Food and Drug Administration (FDA) provides formal guidance for the use of patient-reported outcomes (PROs) in support of labeling claims, whereas the European Medicines Agency (EMA) offers insight in a reflection paper relating to health-related quality of life in lieu of formal guidance. Objectives PRO label claims granted for new molecular entities and biologic license applications from 2006 through 2010 were reviewed to evaluate consistencies and discrepancies in PRO label claims granted by the FDA and the EMA and to highlight trends in the acceptance of PRO claims across agencies. Methods Products approved by both the FDA and the EMA were identified. By using US Drug Approval Packages and European Public Assessment Reports packages, any PRO label claims made for the same product by the same company were compared. Results Both agencies approved a total of 75 products. Of these, 35 (47%) had at least one EMA-granted PRO label claim compared with 14 (19%) by the FDA. Most FDA-grated claims focused on symptoms; however, EMA-granted claims were more likely to include higher order concepts. Few (~12%) were granted the same label claims. Despite this discordance between the two agencies, where PRO label claims were granted by both the FDA and the EMA, there was similarity in the type of label claim. Conclusions The EMA is more likely than the FDA to grant PRO claims and for higher order constructs. On a macro level, there appears to be poor concordance between claims granted by both agencies. On close examination, however, there appears to be greater concordance than previously recognized, which may be instructive in formulating future PRO strategies. Further research to create strategic alignment across agencies may be beneficial. © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

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