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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.

Botteman M.,Pharmerit International | Detzel P.,Nestlé
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.

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.

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.

Moots R.J.,University of Liverpool | Mays R.,Pharmerit International | Stephens J.,Pharmerit International | Tarallo M.,Pfizer
Clinical and Experimental Rheumatology | Year: 2015

Objective: Optimising therapy to minimise disease activity is the goal for treating rheumatoid arthritis (RA) today. In refractory disease requiring biologics, the ability to modify therapy may be limited. In the case of the most widely used biologics, the TNF inhibitors (TNFi), dose escalation consisting of increasing the dose and/or shortening the interval between doses is often reported. Methods: We systematically searched PubMed, EMBASE, Cochrane and Centre of Disseminated Reviews for reports of dose escalation of TNFi in RA and the economic effects of such a practice. Results: Of 41 publications, 36 reported dose escalation and a weighted proportion of dose escalators was calculated for each drug. The proportion of dose escalators varied widely (adalimumab 7.5% to 36%, etanercept 0% to 22%, and infliximab 0% to 80%) due to a variety of methods for defining dose escalation. Based on 33 studies, the weighted proportion of dose escalators was adalimumab 14.9%, etanercept 4.9% and infliximab 41.7%. Six studies reported economic data comparing dose escalators with non-dose escalators. Adalimumab drug costs increased 27% to 43%, with total costs increasing 28% to 34%; infliximab drug costs increased 14% to 71%, RA-related costs increased 25% to 54% and total costs increased 14% to 34% and etanercept drug costs increased 3.2% to 19%, RA-related costs increased 4.5% and total costs increased 2.2% to 15%. Conclusion: Escalating the dose of TNFi in inadequate responders in RA is widespread, occurring most frequently with infliximab and least with etanercept. This practice not only increases drug costs, but also RA-related and total costs. © Clinical and Experimental Rheumatology 2015.

Carter J.A.,Pharmerit International
Expert review of pharmacoeconomics & outcomes research | Year: 2013

Despite effective skeletal-related event (SRE)-limiting therapies such as zoledronic acid and denosumab, SREs continue to place a meaningful burden on patients, providers and payers. However, studies of SRE-related effects on clinical (i.e., survival), economic (i.e., cost per event) and humanistic (i.e., quality of life) outcomes often report results in a composite manner and frequently do not differentiate the effects by SRE-type (i.e., bone radiation, bone surgery, hypercalcemia, pathological fracture and spinal cord compression). Nevertheless, understanding the differential burdens of individual SRE types, which vary in severity and duration of effect, is an important consideration - particularly in pharmacoeconomic evaluations of SRE-limiting therapies. In this review of the clinical, economic and humanistic SRE burden, it was found that SRE types can be differentiated by these outcomes, although economic outcomes are far more frequently reported than clinical or humanistic.

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.

Wiegand P.N.,Pharmerit International | Nathwani D.,Ninewells Hospital and Medical School | Wilcox M.H.,University of Leeds | Stephens J.,Pharmerit International | And 2 more authors.
Journal of Hospital Infection | Year: 2012

PubMed, EMBASE and conference abstracts were reviewed systematically to determine the clinical and economic burden associated with . Clostridium difficile infection (CDI) acquired and treated in European healthcare facilities. Inclusion criteria were: published in the English language between 2000 and 2010, and study population of at least 20 patients with documented CDI acquired/treated in European healthcare facilities. Data collection was completed by three unblinded reviewers using the Cochrane Handbook and PRISMA statement. The primary outcomes were mortality, recurrence, length of hospital stay (LOS) and cost related to CDI. In total, 1138 primary articles and conference abstracts were identified, and this was narrowed to 39 and 30 studies, respectively. Data were available from 14 countries, with 47% of studies from UK institutions. CDI mortality at 30 days ranged from 2% (France) to 42% (UK). Mortality rates more than doubled from 1999 to 2004, and continued to rise until 2007 when reductions were noted in the UK. Recurrent CDI varied from 1% (France) to 36% (Ireland); however, recurrence definitions varied between studies. Median LOS ranged from eight days (Belgium) to 27 days (UK). The incremental cost of CDI was £4577 in Ireland and £8843 in Germany, after standardization to 2010 prices. Country-specific estimates, weighted by sample size, ranged from 2.8% to 29.8% for 30-day mortality and from 16 to 37 days for LOS. CDI burden in Europe was most commonly described using 30-day mortality, recurrence, LOS and cost data. The continued spread of CDI and resultant healthcare burden underscores the need for judicious use of antibiotics. © 2012 The Healthcare Infection Society.

Treur M.,Pharmerit International
The journal of mental health policy and economics | Year: 2015

RESULTS: The model estimates that AOM 400 improves clinical outcomes by reducing relapses per patient comparative to other LAIs over the model time horizon (2.38, 2.53, 2.70, and 2.67 for AOM 400, RLAI, PLAI and OLAI respectively). In the deterministic analysis, AOM 400 dominated PLAI and OLAI; an incremental cost-effectiveness ratio (ICER) of GBP 3,686 per QALY gained was observed against RLAI. Results from the univariate sensitivity analyses highlighted the probability and cost of relapse as main drivers for cost-effectiveness. In the probabilistic sensitivity analysis, AOM 400 demonstrated a marginally higher probability of being cost-effective (51%) than RLAI, PLAI and OLAI (48%, 1% and 0%, respectively) at a willingness to pay threshold of GBP 20,000.DISCUSSION: The model was built to accommodate results of an adjusted MTC analysis. Furthermore the model effectively captures repercussions of deteriorating compliance to treatment by incorporating three levels of compliance with elevated risks of relapse for partial compliance and non-compliance. Limitations of the analysis include the limited number of studies incorporated in the MTC, the extrapolation of short term clinical data and the exclusion of the wider societal burden.IMPLICATIONS FOR HEALTH CARE PROVISION AND USE: Comparative to other atypical antipsychotics, AOM 400 represents value for money in the maintenance treatment of chronic, stable schizophrenia; however, in light of the PSA findings and comparable cost-effectiveness (i.e. against RLAI), the product profile and wider benefits of the respective treatments must be taken into account when prescribing antipsychotics.IMPLICATIONS FOR FURTHER RESEARCH: Future research should assess the use of LAI antipsychotics earlier in the disease course of schizophrenia to see whether improved compliance and outcomes shortly following the onset of psychosis has the potential to alter the disease trajectory. Moreover it should be assessed whether changes in the disease trajectory can alleviate cost and resource pressures placed on national health services.BACKGROUND: Schizophrenia is a severe and debilitating psychiatric disorder. Pharmacological interventions aim to ameliorate symptoms and reduce the risk of relapse and costly hospitalisation. Despite the established efficacy of antipsychotic medication, compliance to treatment is poor, particularly with oral formulation. The emergence of long acting injectable (LAI) antipsychotic formulations in recent years has aimed to counteract the poor compliance rates observed and optimise long term patient outcomes.AIMS OF THE STUDY: To estimate the cost-effectiveness of aripiprazole once-monthly 400mg (AOM 400) vs. risperidone long acting injectable (RLAI), paliperidone long acting injectable (PLAI) and olanzapine long acting injectable (OLAI) in the maintenance treatment of chronic, stable schizophrenia patients in the United Kingdom.METHODS: A Markov model was developed to emulate the treatment pathway of a hypothetical cohort of patients initiating maintenance treatment with LAI antipsychotics. The economic analysis was conducted from a National Health Service (NHS) and Personal Social Services (PSS) perspective over a 10 year time horizon. Efficacy and safety probabilities were derived from mixed treatment comparisons (MTCs) where possible. Analyses were conducted assuming pooled dosing from randomised clinical trials included in the MTCs.

Snedecor S.J.,Pharmerit International | Sudharshan L.,Pharmerit International | Cappelleri J.C.,Pfizer | Sadosky A.,Pfizer | And 2 more authors.
Pain Practice | Year: 2014

Background: Painful diabetic peripheral neuropathy (pDPN) is prevalent among persons with diabetes and increases over time. Published guidelines recommend a number of medications to treat this condition providing clinicians with a variety of treatment options. This study provides a comprehensive systematic review and meta-analysis of published pharmacologic therapies for pDPN. Methods: The published literature was systematically searched to identify randomized, controlled trials of all available pharmacologic treatments for pDPN (recommended or nonrecommended) reporting predefined efficacy and safety outcomes. Bayesian fixed-effect mixed treatment comparison methods were used to assess relative therapeutic efficacy and harms. Results: Data from 58 studies including 29 interventions and 11,883 patients were analyzed. Pain reduction over that of placebo on the 11-point numeric rating scale ranged from -3.29 for sodium valproate (95% credible interval [CrI] = [-4.21, -2.36]) to 1.67 for Sativex (-0.47, 0.60). Estimates for most treatments were clustered between 0 and -1.5 and were associated with more study data and smaller CrIs. Pregabalin (≥ 300 mg/day) was the most effective on the 100-point visual analog scale (-21.88; [-27.06, -16.68]); topiramate was the least (-3.09; [-3.99, -2.18]). Relative risks (RRs) of 30% pain reduction ranged from 0.78 (Sativex) to 1.84 (lidocaine 5% plaster). Analysis of the RR ratio of these 2 treatments reveals marginal significance for Sativex (3.27; [1.07, 9.81]), indicating the best treatment is only slightly better than the worst. Relative risks of 50% pain reduction ranged from 0.98 (0.56, 1.52) (amitriptyline) to 2.25 (1.51, 3.00) (alpha-lipoic acid). RR ratio for these treatments was not statistically different (3.39; [0.88, 3.34]). Fluoxetine had the lowest risk of adverse events (0.94; [0.62, 1.23]); oxycodone had the highest (1.55; [1.45, 1.64]). Discontinuation RRs were clustered around 0.8 to 1.5, with those on the extreme having greater uncertainty. Conclusions: Selecting an appropriate pDPN therapy is key given the large number of available treatments. Comparative results revealed relative equivalence among many of the studied interventions having the largest overall sample sizes and highlight the importance of standardization of methods to effectively assess pain. © 2013 The Authors Pain Practice © 2013 World Institute of Pain.

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