Patient-reported outcomes measures and patient preferences for minimally invasive glaucoma surgical devices.

BackgroundMany therapeutic options are available to glaucoma patients. One recent therapeutic option is minimally invasive glaucoma surgical (MIGS) devices. It is unclear how patients view different treatments and which patient-reported outcomes would be most relevant in patients with mild to moderate glaucoma. We developed a questionnaire for patients eligible for MIGS devices and a patient preference study to examine the value patients place on certain outcomes associated with glaucoma and its therapies.ObjectivesTo summarize the progress to date.MethodsQuestionnaire development: We drafted the questionnaire items based on input from one physician and four patient focus groups, and a review of the literature. We tested item clarity with six cognitive interviews. These items were further refined. Patient preference study: We identified important benefit and risk outcomes qualitatively using semi-structured, one-on-one interviews with patients who were eligible for MIGS devices. We then prioritized these outcomes quantitatively using best-worst scaling methods.ResultsQuestionnaire testing: Three concepts were deemed relevant for the questionnaire: functional limitations, symptoms, and psychosocial factors. We will evaluate the reliability and validity of the 52-item draft questionnaire in an upcoming field test. Patient preference study: We identified 13 outcomes that participants perceived as important. Outcomes with the largest relative importance weights were "adequate IOP control" and "drive a car during the day."ConclusionsPatients have the potential to steer clinical research towards outcomes that are important to them. Incorporating patients' perspectives into the MIGS device development and evaluation process may expedite innovation and availability of these devices

What outcome measures are commonly used for Complex Regional Pain Syndrome clinical trials? A systematic review of the literature

© 2015 European Pain Federation - EFIC®. Background and objective Complex Regional Pain Syndrome (CRPS) is a chronic pain condition, often triggered by trauma to a limb and characterized by sensory, motor, autonomic and trophic changes within the affected limb. Due to the multi-faceted nature of the condition there are a wide range of potential health outcome measures for use within CRPS related clinical trials. This aim of this systematic literature review was to identify which patient or health professional questionnaire format outcome measures have been used in CRPS specific clinical trials, and which of these have been developed specifically for use in CRPS populations. Information gained from this review will inform an international consortium project to define a Core Outcome measurement set for CRPS Clinical trials. Databases and data treatment The electronic databases EMBASE, Medline, PsycInfo, CINAHL and LILACS were systematically searched from January 2000 until April 2014. Results One hundred and four full text papers were obtained with 68 questionnaire outcome measures identified. Five of these outcome measures were validated for CRPS. Of those outcome measures used since 2000, those addressing physical functioning were most prevalent. Conclusions Currently, CRPS clinical trials use a wide range of outcome measures making the potential to synthesize evidence problematic. There is no internationally agreed core measurement set. This diversity of outcome measures demonstrates a clear need for the development of a core measurement set to be used in CRPS clinical trials

Electronic personal assessment questionnaire for vascular conditions (ePAQ-VAS): development and validity

Background This paper describes the development and validation of an electronic personal assessment questionnaire for vascular conditions (ePAQ‐VAS) that captures the symptomatology, quality of life and clinically relevant data of patients presenting to vascular services. Methods A two‐stage survey was conducted in patients attending a tertiary vascular department. Patients completed the ePAQ‐VAS remotely online, or on site using an electronic tablet. In the first stage of the survey, the responses were used to perform confirmatory factor analysis to assess the construct validity and remove redundant items. The internal reliability of disease‐specific scales was investigated. In the second stage of the survey, the acceptability, known‐group validity, test–retest reliability, and responsiveness of ePAQ‐VAS was assessed. Results In total, 721 patients completed ePAQ‐VAS. Their mean(s.d.) age was 63·5(15·7) years and 468 (64·9 per cent) were men. Some 553 patients (76·7 per cent) completed the questionnaire in clinic and the remainder completed the questionnaire online. The results of the confirmatory factor analysis confirmed the conceptual model for ePAQ‐VAS structure and eliminated six items. Internal reliability was acceptable for all the scales (Cronbach's α greater than 0·7). The test–retest reliability measured by the intraclass correlation coefficient ranged from 0·65 to 0·99. The results showed that the instrument was responsive over time with the standardized response mean ranging from 0·69 to 1·60. Conclusion ePAQ‐VAS is a holistic data‐collection process that is relevant to vascular service users and has potential to contribute to patient‐focused care and the collection of aggregate data for service evaluation. A demonstration version of the final version of ePAQ can be viewed at http://demo‐questionnaire.epaq.co.uk/home/project?id=VASC_1.7&page=1