Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
-
By using methods consistent with recent regulatory guidance on patient-reported outcomes as endpoints in clinical trials, we created a new version of the Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (FBSI), with emphasis on patient input during the development process. ⋯ Reflecting the priority symptoms of breast cancer patients and clinicians, the NFBSI-16 can be used to help evaluate the effectiveness of treatments for advanced breast cancer in clinical practice and research.
-
Existing productivity questionnaires do not capture sufficient information to enable the proper valuation of an individual's productivity loss to a society. The purpose of this article is to develop a questionnaire that captures the time lost from work due to a health problem and job and workplace characteristics so that the value of productivity loss to society can be calculated. ⋯ The new questionnaire enabled the job and workplace characteristics to be captured so that the actual productivity loss at the societal level attributable to absenteeism and presenteeism could be valued.
-
Multicenter Study Comparative Study
Further validation of the uterine fibroid symptom and quality-of-life questionnaire.
To further examine the reliability, validity and responsiveness of the uterine fibroid symptom and quality-of-life (UFS-QOL) questionnaire among women with and without uterine fibroids. ⋯ The UFS-QOL is a valid and reliable measure to assess symptoms and HRQL in women with uterine fibroids and is highly responsive to treatment-related changes.
-
The National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) roadmap initiative is a cooperative group program of research designed to develop, evaluate, and standardize item banks to measure patient-reported outcomes relevant across medical conditions. The objective of the current study was to assess feasibility and evaluation of the construct validity of PROMIS item banks versus legacy measures in an observational study in systemic sclerosis (SSc). We hypothesized that the PROMIS item banks can be administered in a clinical setting if there is adequate staff support without disrupting the flow of clinic. ⋯ Our study supports the construct validity of the CAT-administered PROMIS item banks and shows that they can be administered successfully in a clinic with support staff. Future studies should assess the feasibility of PROMIS item banks in a busy clinical practice.
-
The importance of content validity in developing patient reported outcomes (PRO) instruments is stressed by both the US Food and Drug Administration and the European Medicines Agency. Content validity is the extent to which an instrument measures the important aspects of concepts developers or users purport it to assess. A PRO instrument measures the concepts most relevant and important to a patient's condition and its treatment. ⋯ Part 2 details: 1) the methods for conducting cognitive interviews that address patient understanding of items, instructions, and response options; and 2) the methods for tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies. The task force report's two parts are meant to be read together. They are intended to offer suggestions for good practice in planning, executing, and documenting qualitative studies that are used to support the content validity of PRO instruments to be used in medical product evaluation.