These results indicate that improving compliance in actual practice may significantly decrease osteoporosis-related fracture risk.
IntroductionMigraine is a neurological disease characterized by recurring attacks that can cause severe disabling pain. This study described the burden of migraine as reported by individuals with migraine in the real world using a mobile application.MethodsA retrospective, cross-sectional analysis was conducted using data captured through the Migraine Buddy© smartphone application from adult, self-diagnosed individuals with migraine in 17 European countries. Data were analyzed descriptively for the most recent 28-day period reported by users (n = 3900) during the study period (June 2015–July 2016) who were randomly selected on the basis of data completeness (completion rates > 70%) and stratified by migraine headache days/month: 4–7 episodic migraine (EM; n = 1500), 8–14 EM (n = 1500), and chronic migraine (≥ 15; CM; n = 900).ResultsMore than 95% of users reported that migraine negatively affected their daily activities during at least one migraine attack. Attacks affected 50.5% (184.4 days/year), 26.9% (98 days/year), and 14.5% (53 days/year) of the year among CM, 8–14 EM, and 4–7 EM groups, respectively. On average, 44.8% CM, 40.9% 8–14 EM, and 34.7% of 4–7 EM sufferers, respectively, reported anxiety and/or depression symptoms during migraine attacks. Social or home activities, productivity, and sleep were highly affected, regardless of migraine frequency. Employed respondents (n = 3106) reported an average of 2.3 workdays missed per month and that at least one in four migraines led to work absenteeism; these migraines were commonly reported to have at least moderate to severe levels of pain, corresponding to the inability of persons to perform some or even any activities. Triptans (68%), opioids (46%), and nonsteroidal anti-inflammatory drugs (45%) were self-reported as the most common medicines used.ConclusionsThis study, leveraging patient-reported data collected through a mobile application, demonstrates the high burden and impact of migraine on health-related quality of life, work productivity, and overall well-being of individuals suffering from migraines.FundingNovartis Pharma AG, Switzerland.
Presbyopia is the age-related loss of near-distance focusing ability. The aim of this study was to identify patient-reported outcome measures (PROMs) used in clinical trials and quality-of-life studies conducted in individuals with presbyopia and to assess their suitability for use in individuals with phakic presbyopia. Literature searches were performed in Medline and Embase up until October 2017. Specific search terms were used to identify presbyopia studies that included a PROM. All clinical trials with PROM-supported endpoints in presbyopia were identified on ClinicalTrials.gov. Further searches were conducted to retrieve articles documenting the development and psychometric evaluation of the PROMs identified. A total of 703 records were identified; 120 were selected for full-text review. Twenty-one clinical trials employed PROMs to support a primary or secondary endpoint. In total, 13 PROMs were identified; a further 23 publications pertaining to the development and validation of these measures were retrieved. Most PROMs were developed prior to release of the Food and Drug Administration (FDA) 2009 patient-reported outcome guidance and did not satisfy regulatory standards. The Near Activity Visual Questionnaire (NAVQ) was identified as the most appropriate for assessing near-vision functioning in presbyopia. While the NAVQ was developed in line with the FDA guidance, the items do not reflect changes in technology that have occurred since the questionnaire was developed in 2008 (eg, the increase in smartphone use), and the measure was not validated in a purely phakic presbyopia sample. Further research is ongoing to refine the NAVQ to support trial endpoints related to changes in near-vision functioning associated with phakic presbyopia.
Key characteristics of chronic obstructive pulmonary disease (COPD) that significantly affect health-related quality of life (HRQoL) include chest symptoms, dyspnea, cough, sputum production, and exacerbations. Additional areas of impact are sleep, fatigue, emotional well-being, social functioning, and coping. Patient-reported outcomes (PROs) are essential to evaluate symptoms, impact of symptoms on activities of daily living, and treatment response. This review summarizes COPD-specific PRO endpoints from randomized controlled trials of approved and commonly used COPD drugs. A search conducted in “ClinicalTrials.gov” to identify COPD clinical trials (only completed Phase III and IV) incorporating PRO endpoints yielded a total of 104 clinical trials for inclusion in this analysis. Both symptom-based and HRQoL-specific PRO measures were reported. Several COPD-specific PRO measures are available; however, the St. George’s Respiratory Questionnaire (SGRQ) and the Baseline and Transition Dyspnea Indexes (BDI/TDI) were reported in the majority of the studies. Results reflected a gap in terms of full coverage of key impacted areas from a patient’s perspective. Methodological issues identified in this review related to scoring of instruments require careful consideration, as these challenges may limit the complete assessment of drug benefits. Selection of PRO measures aligned with the expected treatment benefit of a drug in a clinical trial should reflect patients’ perspective holistically.
Background Presbyopia is the age-related deterioration in the ability to focus on close objects. In order to develop a patient-reported outcome (PRO) instrument to assess near vision functioning, the Near Activity Visual Questionnaire (NAVQ) was adapted to incorporate modern technology (e.g. smartphones) and to be appropriate for use in phakic presbyopia, leading to the development of the NAVQ-Presbyopia (NAVQ-P). Additional single-item instruments of near vision correction independence (NVCI), correction preference (NVCP), and vision satisfaction (NVS) were also developed. The study aimed to evaluate the content validity of the NAVQ-P and additional instruments in individuals with phakic presbyopia. Methods Participants in the US (n = 15), Germany (n = 10) and France (n = 10) took part in face-to-face, qualitative, cognitive debriefing interviews. Seven healthcare professionals (HCPs) were also interviewed to assess the clinical relevance of the PRO instruments. Interviews started with open-ended qualitative concept elicitation questioning; participants then completed the PRO instruments on an electronic tablet using a “think-aloud” process and were asked about their understanding and relevance of each item, instruction, response scale and recall period. Interviews were conducted in two rounds allowing for modifications between rounds. Results The participants interpreted the majority of the PRO instruments and recall period correctly and consistently. They were able to select an appropriate response option without difficulty. Minor modifications were made to the PRO instruments based on interview findings. Instruction/item wording was modified to include reference to use of a magnifying glass, in addition to glasses and contact lenses. Two items were added to assess difficulty with precision tasks (e.g. sewing) and taking longer to adjust from distance to near vision. HCPs confirmed the relevance of the concepts being measured for presbyopia and recommended the addition of an item assessing contrast sensitivity. Conclusions Developed in accordance with the FDA PRO Guidance, the findings support content validity of the NAVQ-P as a suitable, well-understood instrument of relevant near vision functioning concepts in individuals with phakic presbyopia. The NVCI and additional PRO instruments are appropriate to assess near vision correction independence, correction preference, and vision satisfaction. Future work will assess the psychometric properties of the NAVQ-P and additional PRO instruments.
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