| Patient Reported Outcomes Studies The Health Outcomes Group methodology: First,we develop the study design by choosing the appropriate patient reported outcomes questionnaire(s). Next, we carefully monitor data collection. Once the collection of the data is complete, we perform statistical analysis on the raw data. After we have finished the analysis the last step is to write the study report and publish our findings in the appropriate journals. Epidemiologic Studies Health Outcomes Group is experienced in the four major types of epidemiologic studies: Natural History of Disease - Follow patients longitudinally to characterize when the effects occur and their magnitudes Case Control Study - Non-interventional study to assess the effects of a case group relative to a control group Cohort Study - Follow similar groups of patients who all underwent the baseline treatment at different times to assess complications and side-effects and their timing Population Survey - Survey of the general population to estimate the incidence or prevalence of key events and to determine attitudes about subjects of interest | Statistical Validation of Questionnaires The Health Outcomes Group methodology for validating a questionnaire in multiple languages: First, we look for linguistic equivalence between the questionnaires in all required languages. Our goal is that patients in the target population reading a translation of the questionnaire have an understanding that is functionally equivalent to that of similar patients reading the questions in the source language. Next, we measure statistical equivalence by performing a statistical assessment of the performance characteristics of two or more samples of patients completing linguistically-equivalent questionnaires. When performing the statistical assessment we are looking for: internal consistency equivalence, reliability equivalence, responsiveness equivalence of both positive changes and negative changes and meaningfulness equivalence. Economic Evaluations Our objective for economic evaluations is to conduct studies to assess the cost of disease and treatment with analyses to determine whether a treatment provides cost-benefits or is cost-effective, when compared to alternative treatments. |
