LABA/LAMA combinations versus LAMA monotherapy or LABA/ICS in COPD : a systematic review and meta-analysis

Acknowledgments The meta-analysis work was performed by Guruprasad Rao KS and Sharanbasappa Durg of Molecular Connections (P) Ltd, Bangalore, India, under the guidance of the manuscript authors and Novartis Pharma AG (Basel, Switzerland). Medical writing assistance was provided by Colette O’Sullivan, PhD, of Scriva Medical Communications Ltd, a professional medical writer funded by Novartis. Development of the manuscript was supported by Novartis Pharma AG (Basel, Switzerland). The authors received no compensation related to the development of the manuscript.Peer reviewedPublisher PD

Patient-reported outcome measures in presbyopia: a literature review

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

Evaluation of the content validity of patient-reported outcome (PRO) instruments developed for use with individuals with phakic presbyopia, including the Near Activity Visual Questionnaire-presbyopia (NAVQ-P) and the near vision correction independence (NVCI) instrument

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

Understanding the visual function symptoms and associated functional impacts of phakic presbyopia

Background: Presbyopia is defined as the age-related deterioration in the ability to focus on close objects, causing difficulty with near vision tasks. The study aim was to understand the lived experience of phakic presbyopia and identify all relevant visual function symptoms and associated functional impacts. Methods: Fifty individuals with clinician-confirmed phakic presbyopia (US n = 30, France n = 10, Germany n = 10) and seven healthcare professionals (HCPs) participated in in-depth, face-to-face, qualitative concept elicitation interviews. Verbatim transcripts were analyzed using thematic analysis methods. Results: Visual function symptoms reported by participants with phakic presbyopia were categorized as: primary near vision functioning symptoms (impaired near visual acuity, n = 50/50, 100%; difficulty with near vision in dim light, n = 42/50, 84%; difficulty focusing at close distances, n = 30/50, 60%; difficulty seeing things when glare is present, n = 30/50, 60%) and secondary symptoms (eye strain, n = 37/50, 74%; dry eyes, n = 35/50, 70%; headaches, n = 30/50, 60%). Proximal impacts on functional vision included difficulty reading in near vision (n = 49/50, 98%, including printed text and handwriting), seeing objects in near vision n = 48/50, 96%, and performing activities of daily living that require near vision (n = 49/50, 98%, including using a smartphone or computer). Distal impacts on functional vision included emotional, work, financial and social impacts. HCP interviews supported participant findings. Conclusion: Findings provide a comprehensive understanding of the lived experience of phakic presbyopia which informed the development of a presbyopia conceptual model and patient-reported outcome assessments of vision correction independence and near vision functioning. The sample did not include those whose vision cannot be adequately corrected with lenses or surgery

Comparison of Literature Review, Social Media Listening, and Qualitative Interview Research Methods in Generating Patient-Reported Symptom and Functional Impact Concepts of Presbyopia

INTRODUCTION: To compare the insights obtained about the experience of individuals with presbyopia (age-related impaired near vision) across three different sources of qualitative data: a structured targeted literature review, a social media listening (SML) review, and qualitative concept elicitation (CE) interviews with individuals with presbyopia and healthcare professionals (HCPs). The number of concepts identified, depth of data, cost and time implications, and value of the patient insights generated were explored and compared for each method. METHODS: Keyword searches in bibliographic databases and review of abstracts identified 120 relevant publications; in-depth targeted literature review of the qualitative studies identified key symptoms/functioning concepts. SML was conducted using publicly accessible social media sources with focus on ophthalmologic diseases using a pre-defined search string. Relevant posts from individuals with presbyopia (n = 270) were analysed and key concepts identified. Semi-structured CE interviews were conducted with individuals with presbyopia (US n = 30, Germany n = 10, France n = 10), and HCPs (US = 3, France n = 2, Germany n = 1, Japan n = 1) who were experienced in treating presbyopia. Verbatim transcripts were coded using thematic analysis. A conceptual model summarised concepts identified across sources RESULTS: Out of the total of 158 concepts identified across the three sources, qualitative CE interviews yielded the highest number of concepts (n = 151/158, 96%), with SML yielding a third of the concepts (n = 51/158, 32%) and the literature review yielding the fewest concepts (n = 33/158, 21%). Qualitative CE interviews provided greater depth of data than SML and literature reviews. SML and literature reviews were less costly and quicker to run than qualitative CE interviews and also were less burdensome for participants. CONCLUSION: Qualitative CE interviews are considered the gold standard in providing greater depth of understanding of the patient experience, and more robust data. However, research requirements, budget, and available time should be considered when choosing the most appropriate research method. More time and cost-effective SML and literature review methods can be used to supplement qualitative CE interview data and provide early identification of measurement concepts. More research and regulatory guidance into less traditional qualitative methods, however, are needed to increase the value of SML and literature review data

Anxiety and self-esteem as mediators of the relation between family communication and indecisiveness in adolescence

Abstract In this study, we explored the unique and common contributions of anxiety, self-esteem, and family communication on indecisiveness among adolescents. Three hundred and fifty pupils from 13 to 16 years of age completed selfreport measures on indecisiveness, quality of family communication, trait anxiety, and self-esteem. The findings in this study showed that students\u2019 indecisiveness is predicted by family communication mediated by anxiety and self-esteem. These results have important implications for practice as it stresses the importance of anxiety and self-esteem. Nevertheless, the counselors could also focus on enhancing relationship-building skills by introducing the adolescents\u2019 career formation as an adolescent\u2013parent joint project.L\u2019anxie\ub4te\ub4 et l\u2019estime de soi comme me\ub4diateurs de la relation entre communication au sein de la famille et indecision chronique a` l\u2019adolescence. Dans cette e\ub4tude, nous avons explore\ub4 les contributions uniques et communes de l\u2019anxiete\ub4, de l\u2019estime de soi et de la communication au sein de la famille sur l\u2019indecision chronique aupres d\u2019adolescents. Trois cent cinquante e\ub4le`ves a\u2c6ge\ub4s de 13 a` 16 ans ont rempli des mesures d\u2019auto-e\ub4valuation de l\u2019inde\ub4cision chronique, de la qualite\ub4 de la communication familiale, de l\u2019anxie\ub4te\ub4-trait et de l\u2019estime de soi. Les re\ub4sultats de cette e\ub4tude ont montre\ub4 que l\u2019inde\ub4cision des e\ub4tudiants est explique\ub4e par la communication au sein de la famille et que ce lien est me\ub4diatise\ub4 par l\u2019anxie\ub4te\ub4 et l\u2019estime de soi. Ces re\ub4sultats ont des implications importantes pour la pratique car ils soulignent l\u2019importance de l\u2019anxie\ub4te\ub4 et l\u2019estime de soi. Ne\ub4anmoins, les conseillers pourraient e\ub4galement se concentrer sur l\u2019ame\ub4lioration des compe\ub4tences de construction relationnelle en introduisant la formation professionnelle des adolescents comme un projet conjoint adolescent-parent.Resumen. Ansiedad y Autoestima como Mediadores de la Relacio\ub4n entre Comunicacio\ub4n Familiar e Indecisio\ub4n en la Adolescencia. En este estudio, exploramos las contribuciones u\ub4nicas y comunes de la ansiedad, la autoestima y la comunicacio\ub4n de familia en la indecisio\ub4n de los adolescentes. Tres y cientos cincuenta alumnos entre los 13 y 16 an\u2dcos completaron auto-evaluaciones sobre la indecisio\ub4n, la calidad de comunicacio\ub4n familiar, los rasgos de ansiedad y la autoestima. Los resultados en este estudio muestran que la indecisio\ub4n en los estudiantes es prevista por la comunicacio\ub4n familiar mediada por la ansiedad y la autoestima. Estos resultados tiene importantes implicaciones para la practica ya que destacan la importancia de la ansiedad y la autoestima. Sin embargo, los consejeros podr\u131\ub4an tambie\ub4n focalizarse en el aumento de sus habilidades para construir relaciones mediante la introduccio\ub4n de la formacio\ub4n profesional para adolescentes como un proyecto conjunto del adolescente-padre.Angst und Selbstwertgefu\ua8 hl als Mediatoren der Beziehung zwischen Kommunikation in der Familie und Unentschlossenheit in der Adoleszenz. In dieser Studie untersuchten wir die spezifischen und gemeinsamen Beitra\ua8ge von Angst, Selbstwertgefu\ua8hl und Kommunikation in der Familie auf Unentschlossenheit unter Jugendlichen. Dreihundertfu\ua8nfzig Schu\ua8ler, zwischen 13 bis 16 Jahre alt, fu\ua8llten Skalen zur Unentschlossenheit, Qualita\ua8t der Kommunikation in der Familie, A\ua8 ngstlichkeit und Selbstwertgefu\ua8hl aus. Die Ergebnisse dieser Studie zeigten, dass Unentschlossenheit der Schu\ua8ler von Kommunikation in der Familie vorhergesagt wird, vermittelt durch Angst und Selbstwertgefu\ua8 hl. Diese Ergebnisse haben wichtige Implikationen fu\ua8r die Praxis, da sie die Bedeutung von Angst und Selbstwertgefu\ua8hl hervorheben. Dennoch ko\ua8nnten sich die Beratungspersonen durch die Einfu\ua8hrung der beruflichen Bildung der Jugendlichen als ein gemeinsames Projekt von Jugendliche-Elternteil auch auf die Verbesserung der Fa\ua8higkeiten zum Aufbau von Beziehungen konzentrieren

Processo innovativo di assemblaggio per treni modulari ed analisi delle tolleranze in ambiente virtuale

Il presente lavoro riguarda il processo produttivo che conduce alla realizzazione della cassa completa di un veicolo ferroviario. La prima parte del lavoro riguarda un’ipotesi di “fabbrica digitale” realizzata per l’esigenza di sviluppare e visualizzare un ciclo di montaggio innovativo rispetto ai criteri che, quasi generalmente, rappresentano lo stato dell’arte nella fabbricazione del materiale rotabile. La cassa, secondo il processo di assemblaggio proposto, è composta da quattro moduli che vengono singolarmente allestiti di impianti ed arredi in postazioni dedicate e successivamente assemblati nella postazione di assemblaggio finale. La simulazione in ambiente virtuale ha consentito, da un lato, di evidenziare i punti critici sui quali i progettisti debbono focalizzare la loro attenzione per definire una soluzione innovativa, in grado di assicurare evidenti vantaggi in termini di fattibilità, di tempi e di costi; dall’altro, di rendere chiaramente visibile la movimentazione delle parti all’interno dell’impianto e le sequenze di assemblaggio dei componenti e dei moduli, valutando tutti i vincoli di compatibilità, dal punto di vista geometrico, funzionale e tecnologico. La seconda parte del lavoro riguarda la simulazione delle sequenze di assemblaggio e l’analisi delle tolleranze mediante un sistema di Computer Aided Tolerancing (CAT). In particolare la simulazione ha consentito di analizzare i requisiti di precisione che l’innovativo processo produttivo richiede. Infatti, è stato possibile confrontare l’accumulo degli errori dimensionali e geometrici relativi ad una soluzione che prevede l’impiego di particolari giunzioni rivettate con quello relativo alla soluzione, usualmente adottata, che prevede l’uso di collegamenti saldati

GOVERNO E GESTIONE DI BAGNOLI . Idee, confronti e prospettive

GOVERNO E GESTIONE DI BAGNOLI . Idee, confronti e prospettiv