The mapping of paediatric vaccination process in the United Kingdom (UK), as a precursor of a real-world study, is described. Methods: A targeted review of publicly available information was conducted to gain comprehensive understanding of the paediatric vaccination process in the UK. A survey was designed eliciting the chronology of vaccination process prior to and on vaccination day, including estimates of active health care professional involvement. Face-to-face interviews with a nurse were conducted at three general practitioner surgeries routinely performing vaccinations. A subsequent follow-up call with each nurse was also arranged. Descriptive statistics were generated and preliminary cost calculations made. Results: Paediatric vaccination process can be broken down in 6 and 8 clearly discernible steps prior to and on vaccination day, respectively. Activities prior to vaccination day include, among others, inventory, ordering, cold-chain management and are typically for multiple subjects. Mean time for those activities, recalculated per single vaccination visit, was 6.7 minutes, of which 61% dedicated to administrative duties. Activities on vaccination day include, among others, room preparation, consultation, vaccine administration. Estimated time per single visit totaled 25.4 minutes. Estimated total cost per single vaccine administration, with nurse salary cost from PSSRU, was £10.4. Costs may vary substantially depending on the level of "on-costs" to nurse's gross salary. ConClusions: The detailed mapping of paediatric vaccination process in the UK identified clearly discernible tasks, time estimates, factors impacting variability of time outcomes, and early cost estimates. This forms the basis of a real-world T&M study aiming to generate robust time and cost outcomes.objeCtives: Guidelines for Health Technology Assessment (HTA) and Comparative Effectiveness Research (CER) largely focus on pharmaceuticals and only few explicitly consider other health care technologies. CER of medical devices (MD) faces some challenges that raise questions about how adequate current CER methods account for the specific features of MD and how well MD fit in the paradigm of drug HTA. Our aim was to identify challenges and gaps in methodology related to specific issues of MD. Our comprehensive framework for the evaluation of clinical effectiveness of MD includes recommendations for generation of primary data and analyzing and synthesizing data in systematic reviews of CER of MD. Methods: We performed a targeted literature review for CER methods and specific features of MD. An electronic database search was combined with systematic screening of tables of content of selected journals in the fields of epidemiology, HTA, statistics, and evidence-based medicine, which have a strong focus on methods. Additionally, we screened the reference lists of the most relevant papers. Results: More than 200 publications about the general evaluation of MD and about specific CER methods were included. The MD's physical mechanism of action, t...
and diagnosis of bipolar I mixed disorder (ICD-9-CM: 296.6x) from MarketScan® claims databases, yielded 230 ASE, 2726 aripiprazole, 984 olanzapine, 3056 quetiapine, and 1623 risperidone patients. PS were derived using logistic regression models for ASE and each AA with baseline demographic and clinical characteristics as covariates. PS, inverse probability treatment weight (IPTW: 1/ PS ASE; 1/ (1-PS) AA), and standard mortality ratio weight (SMR: 1 ASE; PS/ (1-PS) AA) distributions were evaluated. ASE-AA un-weighted, IPTW, and SMR baseline characteristics were compared using standardized differences, chi-squares, and t-tests. Results: Un-weighted asenapine patients had pre-index greater bipolar I episodes rates, psychiatric drug use, dyslipidemia and obesity (all comparators). PS distributions for asenapine-olanzapine overlapped to some degree while PS of asenapine and the other comparators overlapped little to not at all. Comparing IPTW baseline characteristics, asenapine more resembled the AA cohorts. Demographic imbalance increased between asenapine and each AA. IPTW improved clinical characteristic balance for asenapine versus olanzapine and risperidone, but only slightly improved imbalance versus aripiprazole and quetiapine. However some clinical characteristics not previously balanced in the un-weighted analyses for asenapine versus each AA were now imbalanced. Applying SMR, AA cohorts more resembled the asenapine cohort and all baseline demographic and clinical characteristics were finally balanced. ConClusions: SMR, a less common PS method, resulted in balanced baseline characteristics. SMR should be considered when IPTW leaves imbalance and the cohort of primary interest differs significantly from the broader underlying population to which it's being compared.
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