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Saramago P.,University of York | Chuang L.-H.,Pharmerit International | Soares M.O.,University of York
BMC Medical Research Methodology | Year: 2014

Background: Network meta-analysis methods extend the standard pair-wise framework to allow simultaneous comparison of multiple interventions in a single statistical model. Despite published work on network meta-analysis mainly focussing on the synthesis of aggregate data, methods have been developed that allow the use of individual patient-level data specifically when outcomes are dichotomous or continuous. This paper focuses on the synthesis of individual patient-level and summary time to event data, motivated by a real data example looking at the effectiveness of high compression treatments on the healing of venous leg ulcers.Methods. This paper introduces a novel network meta-analysis modelling approach that allows individual patient-level (time to event with censoring) and summary-level data (event count for a given follow-up time) to be synthesised jointly by assuming an underlying, common, distribution of time to healing. Alternative model assumptions were tested within the motivating example. Model fit and adequacy measures were used to compare and select models.Results: Due to the availability of individual patient-level data in our example we were able to use a Weibull distribution to describe time to healing; otherwise, we would have been limited to specifying a uniparametric distribution. Absolute effectiveness estimates were more sensitive than relative effectiveness estimates to a range of alternative specifications for the model.Conclusions: The synthesis of time to event data considering individual patient-level data provides modelling flexibility, and can be particularly important when absolute effectiveness estimates, and not just relative effect estimates, are of interest. © © 2014 Saramago et al.; licensee BioMed Central Ltd. Source

Charokopou M.,Pharmerit International
Current Medical Research and Opinion | Year: 2016

This editorial accompanies a research article being published by Clinical Medical Research and Opinion (CMRO) journal, entitled »Methods applied in cost-effectiveness models for treatment strategies in type 2 diabetes mellitus and their use in Health Technology Assessments: a systematic review of the literature from 2008 to 2013». The importance and the contribution of this research to the scientific community are presented on the grounds of serving the decision-making process of evaluating and approving T2DM treatments for public funding. © 2015 Taylor & Francis. Source

Botteman M.,Pharmerit International | Detzel P.,Nestle
Annals of Nutrition and Metabolism | Year: 2015

Background: Atopic dermatitis (AD) is one of the most common skin conditions among infants. Proteins found in cow's milk formula (CMF) have been found to be attributable to heightened AD risk, particularly in infants with familial AD heredity. Previous studies have suggested that intervention with partially hydrolyzed formula in nonexclusively breastfed infants can have a protective effect against AD development. Objective: The aim of the present study was to compare the estimates of the economic impact of reducing the AD incidence by feeding a partially hydrolyzed whey-based formula (PHF-W) instead of a standard CMF to high-risk nonexclusively breastfed urban infants for the first 17 weeks of life in the Philippines, Malaysia, and Singapore. Methods: In each country, a mathematical model simulated AD incidence and burden from birth to 6 years of age of using PHF-W versus CMF in the target population using data from the German Infant Nutritional Intervention study. The models integrated literature, current cost and market data, and expert clinician opinion. Modeled outcomes included AD risk reduction, time spent after AD diagnosis, AD symptom-free days, quality-adjusted life years (QALYs), and costs (direct and indirect). Outcomes were discounted at 3% per year. Costs were expressed in USD. Results: Feeding high-risk infants PHF-W instead of CMF resulted in an estimated absolute 14% (95% CI 1-24) AD risk reduction, a 0.69-year (95% CI 0.25-1.13) reduction in the time spent after AD diagnosis per child, reductions of 16-38 AD days, and gains in 0.02-0.04 QALYs, depending on the country. The per-child AD-related 6-year cost-saving estimates of feeding high-risk infants with PHF-W versus CMF were USD 739 in Singapore, USD 372 in Malaysia, and USD 237 in the Philippines. © 2015 S. Karger AG, Basel. Source

Bredart A.,University of Paris Descartes | Marrel A.,Access France | Abetz-Webb L.,Patient Centred Outcomes Assessments | Lasch K.,Pharmerit International | Acquadro C.,Mapi Research Trust
Health and Quality of Life Outcomes | Year: 2014

Patient-reported outcome (PRO) measures must provide evidence that their development followed a rigorous process for ensuring their content validity. To this end, the collection of data is performed through qualitative interviews that allow for the elicitation of in-depth spontaneous reports of the patients' experiences with their condition and/or its treatment. This paper provides a review of qualitative research applied to PRO measure development. A clear definition of what is a qualitative research interview is given as well as information about the form and content of qualitative interviews required for developing PRO measures. Particular attention is paid to the description of interviewing approaches (e.g., semi-structured and in-depth interviews, individual vs. focus group interviews). Information about how to get prepared for a qualitative interview is provided with the description of how to develop discussion guides for exploratory or cognitive interviews. Interviewing patients to obtain knowledge regarding their illness experience requires interpersonal and communication skills to facilitate patients' expression. Those skills are described in details, as well as the skills needed to facilitate focus groups and to interview children, adolescents and the elderly. Special attention is also given to quality assurance and interview training. The paper ends on ethical considerations since interviewing for the development of PROs is performed in a context of illness and vulnerability. Therefore, it is all the more important that, in addition to soliciting informed consent, respectful interactions be ensured throughout the interview process. © 2014 Brédart et al.; licensee BioMed Central Ltd. Source

Palmer P.,AacelRx Pharmaceuticals Inc | Ji X.,Pharmerit International | Stephens J.,Pharmerit International
ClinicoEconomics and Outcomes Research | Year: 2014

Background: Intravenous patient-controlled analgesia (PCA) equipment and opioid cost analyses on specific procedures are lacking. This study estimates the intravenous PCA hospital cost for the first 48 postoperative hours for three inpatient surgeries. Methods: Descriptive analyses using the Premier database (2010-2012) of more than 500 US hospitals were conducted on cost (direct acquisition and indirect cost for the hospital, such as overhead, labor, pharmacy services) of intravenous PCA after total knee/hip arthroplasty (TKA/THA) or open abdominal surgery. Weighted average cost of equipment and opioid drug and the literature-based cost of adverse events and complications were aggregated for total costs. Results: Of 11,805,513 patients, 272,443 (2.3%), 139,275 (1.2%), and 195,062 (1.7%) had TKA, THA, and abdominal surgery, respectively, with approximately 20% of orthopedic and 29% of abdominal patients having specific intravenous PCA database cost entries. Morphine (57%) and hydromorphone (44%) were the most frequently used PCA drugs, with a mean cost per 30 cc syringe of $16 (30 mg) and $21 (6 mg), respectively. The mean number of syringes used for morphine and hydromorphone in the first 48 hours were 1.9 and 3.2 (TKA), 2.0 and 4.2 (THA), and 2.5 and 3.9 (abdominal surgery), respectively. Average costs of PCA pump, intravenous tubing set, and drug ranged from $46 to $48, from $20 to $22, and from $33 to $46, respectively. Pump, tubing, and saline required to maintain patency of the intravenous PCA catheter over 48 hours ranged from $9 to $13, from $8 to $9, and from $20 to $22, respectively. Supplemental non-PCA opioid use ranged from $56 for THA to $87 for abdominal surgery. Aggregated mean intravenous PCA equipment and opioid cost per patient were $196 (THA), $204 (TKA), and $243 (abdominal surgery). Total costs, including for adverse events, complications, and intravenous PCA errors, ranged from $647 to $694. Conclusion: Although there is variation between different types of surgery, the hospital cost of intravenous PCA after major surgery is substantial. Novel technology should demonstrate cost-effectiveness in addition to clinical superiority. © 2014 Palmer et al. Source

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