Qualitative Development of the Allergan Satisfaction with Treatment Experience Questionnaire (ASTEQ) Instrument, a Patient-Reported Outcome Measure in Glaucoma and Ocular Hypertension.

Introduction: Sustained-release intraocular implants provide a therapeutic option for open-angle glaucoma (OAG) and ocular hypertension (OHT) patients who are non-compliant with eyedrops. Currently, there are no published patient-reported outcome (PRO) measures that assess treatment satisfaction with intraocular implants. To address this gap, a new PRO instrument, the Allergan Satisfaction with Treatment Experience Questionnaire (ASTEQ), has been developed in accordance with Food and Drug Administration guidance.

Patient-reported outcomes and quality of life in advanced ALK+ non-small-cell lung cancer trial of brigatinib (ALTA).

Patient-reported outcomes (PRO) can support clinically relevant primary end points. The ALTA trial, an open-label, Phase II, randomized dose-comparison study, evaluated the safety and efficacy of brigatinib in ALK+ non-small-cell lung cancer. PRO data collection included the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30).

Converting EORTC QLQ-C30 scores to utility scores in the brigatinib ALTA study.

Health utilities summarize a patient's overall health status. This study estimated utilities based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30), a widely used measure of health-related quality-of-life (HRQoL) in oncology, using published mapping algorithms. Data were from the Anaplastic Lymphoma Kinase (ALK) in Lung Cancer Trial of brigatinib (ALTA; NCT02094573), an open-label, international, phase 2 study.

Comparative efficacy of brigatinib versus ceritinib and alectinib in patients with crizotinib-refractory anaplastic lymphoma kinase-positive non-small cell lung cancer.

Objective: Brigatinib, ceritinib, and alectinib are approved to treat crizotinib-refractory anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC), but no trial has compared them head-to-head. A matching-adjusted indirect comparison (MAIC) was conducted to estimate the relative efficacy of these agents in the crizotinib-refractory setting.

Methods: MAIC is a propensity score-type method that adjusts for differences in baseline characteristics between trials to estimate relative efficacy.

The budget impact of cervical cancer screening using HPV primary screening.

Objectives: This study assessed the clinical and budgetary impacts of human papillomavirus (HPV) primary screening with HPV16/18 genotyping, in contrast to current cervical cancer screening strategies.

Study Design: A decision-tree framework and Markov model were used to model clinical and cost implications of screening and diagnosis of disease.

Methods: A model was developed to compare the annual clinical and budgetary impact of HPV screening with genotyping versus cytology, and co-testing with and without genotyping.

Cost effectiveness of human papillomavirus-16/18 genotyping in cervical cancer screening.

Background: There is limited understanding of the health economic implications of cervical screening with human papillomavirus (HPV)-16/18 genotyping.

Objective: The aim of this study was to evaluate the cost effectiveness of cervical cancer primary screening with a HPV-16/18 genotyping test which simultaneously detects 12 other high-risk HPV types.

Methods: A Markov cohort model compared four strategies: (1) cytology with reflex HPV testing for atypical squamous cells of undetermined significance (ASC-US); (2) co-testing with cytology and HPV testing; (3) HPV with reflex to cytology; and (4) HPV with 16/18 genotyping and reflex cytology (ASC-US threshold).

Cost effectiveness of denosumab versus oral bisphosphonates for postmenopausal osteoporosis in the US.

Background: In the US, 26 % of women aged ≥65 years, and over 50 % of women aged ≥85 years are affected with postmenopausal osteoporosis (PMO). Each year, the total direct health care costs are estimated to be $US12-18 billion.

Objective: The cost effectiveness of denosumab versus oral bisphosphonates in postmenopausal osteoporotic women from a US third-party payer perspective was evaluated.

Influence of patient perceptions and preferences for osteoporosis medication on adherence behavior in the Denosumab Adherence Preference Satisfaction study.

Objective: This study aims to evaluate patient perceptions of subcutaneous denosumab or oral alendronate in postmenopausal women with or at risk for osteoporosis and how these perceptions influence adherence.

Methods: Postmenopausal women with low bone mass were randomized to denosumab 60 mg every 6 months for 1 year (treatment period 1 [TP1]) followed by alendronate 70 mg once weekly for 1 year (treatment period 2 [TP2]), or vice versa. Beliefs about Medicines Questionnaire data were collected at baseline and at 6, 12, 18, and 24 months; a necessity-concerns differential (NCD) was calculated for each time point.

Prostate cancer screening trends in a large, integrated health care system.

Background: As the debate over the effectiveness of prostate-specific antigen (PSA) screening for prostate cancer continues, it is increasingly important to understand how PSA screening occurs in general-practice settings.

Methods: We conducted a retrospective cohort study within Kaiser Permanente Southern California, a large integrated health care system. Men aged 35 years and older at baseline, in 1998, were eligible.

Cost-effectiveness of Prostate Health Index for prostate cancer detection.

Objective: • To evaluate the cost-effectiveness of early prostate cancer detection with the Beckman Coulter Prostate Health Index (phi) (not currently available in the USA) adding to the serum prostate-specific antigen (PSA) test compared with the PSA test alone from the US societal perspective.

Patients And Methods: • Phi was developed as a combination of PSA, free PSA, and a PSA precursor form [-2]proPSA to calculate the probability of prostate cancer and was used as an aid in distinguishing prostate cancer from benign prostatic conditions for men with a borderline PSA test (e.g.

Economic burden of atopic manifestations in patients with atopic dermatitis--analysis of administrative claims.

Background: Atopic dermatitis (AD) has been associated with atopic manifestations (AMs), such as food allergies, asthma, allergic rhinitis, and allergic conjunctivitis.

Objectives: To (1) compare the risk of developing AMs in patients with AD versus those without AD, (2) estimate the incremental costs attributable to AMs in patients with AD, and (3) examine the factors associated with incremental costs.

Methods: In this retrospective cohort study, the authors used MarketScan research databases containing medical and pharmacy claims with dates of service from January 1, 1999, to December 31, 2004.