Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
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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 that developers or users purport it to assess. A PRO instrument measures the concepts most significant and relevant to a patient's condition and its treatment. ⋯ Part 2 covers the instrument development process, the assessment of patient understanding of the draft instrument using cognitive interviews and steps for instrument revision. The two parts are meant to be read together. They are intended to offer suggestions for good practices 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.
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Meta Analysis
Developing and applying a stochastic dynamic population model for chronic obstructive pulmonary disease.
To develop a stochastic population model of disease progression in chronic obstructive pulmonary disease (COPD) that includes the effects of COPD exacerbations on health-related quality of life, costs, disease progression, and mortality and can be used to assess the effects of a wide range of interventions. ⋯ The COPD model provides policy makers with information about the long-term costs and effects of interventions over the entire chain of care, from primary prevention to care for very severe COPD and includes uncertainty around the outcomes.
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Comparative Study
Cost-effectiveness of dasatinib and nilotinib for imatinib-resistant or -intolerant chronic phase chronic myeloid leukemia.
To estimate the cost-effectiveness of dasatinib and nilotinib compared with high-dose imatinib for people with chronic phase chronic myeloid leukemia, which are resistant to normal-dose imatinib and compared with interferon-α for people intolerant to imatinib, from the perspective of the UK National Health Service. ⋯ The model should be viewed as an exploratory analysis of the cost-effectiveness of dasatinib and nilotinib because it relies on many assumptions. Whilst clinical data remains immature, the cost-effectiveness of dasatinib and nilotinib for imatinib-resistant people is highly uncertain. Both nilotinib and dasatinib are highly unlikely to be cost-effective versus interferon-α for people intolerant to imatinib.
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Meta Analysis
Esophageal Doppler monitoring during colorectal resection offers cost-effective improvement of hemodynamic control.
Hemodynamic control can improve the outcome of surgery. Esophageal Doppler monitoring measures blood flow by ultrasound waves. This work investigates the cost-effectiveness of this procedure during colorectal resection. ⋯ Although the information regarding the clinical effectiveness of esophageal Doppler monitoring in colorectal resection is limited, strategies including this form of blood flow monitoring may be cost-effective. Further comparisons of Doppler monitoring against other hemodynamic monitoring systems should be undertaken.
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Generic health status measures such as the short form health survey (SF-36) and EuroQol-5D (EQ-5D) are increasingly being used to inform health policy. They are claimed to be applicable across disease areas and have started to be used within mental health research. This review aims to assess the construct validity and responsiveness of four generic health status measures in schizophrenia, including the preference-based SF-6D and EQ-5D. ⋯ Although the evidence base is limited in a number of important respects, including problems with the measures used to develop constructs in the validation studies, it is sufficient to raise doubts about the use of generic measures of health like the EQ-5D and SF-36 in patients with schizophrenia.