scholarly journals FRI0472 Towards a multidimensional patient reported outcome measures assessment: development and validation of a questionnaire for patients with systemic sclerosis/scleroderma

Author(s):  
Y. El Miedany ◽  
M. El Gaafary ◽  
N. El Aroussy ◽  
S. Youssef ◽  
Y. Atef ◽  
...  
2020 ◽  
Vol 5 (2_suppl) ◽  
pp. 48-60
Author(s):  
Lesley Ann Saketkoo ◽  
Mary Beth Scholand ◽  
Matthew R. Lammi ◽  
Anne-Marie Russell

Systemic sclerosis (SSc) is a progressive vasculopathic, fibrosing autoimmune condition, portending significant mortality; wherein interstitial lung disease (ILD) is the leading cause of death. Although lacking a definitive cure, therapeutics for (SSc-ILD) that stave progression exist with further promising primary and adjuvant compounds in development, as well as interventions to reduce symptom burden and increase quality of life. To date, there has been a significant but varied history related to systemic sclerosis–related interstitial lung disease trial design and endpoint designation. This is especially true of endpoints measuring patient-reported perceptions of efficacy and tolerability. This article describes the underpinnings and complexity of the science, methodology, and current state of patient-reported outcome measures used in (SSc-ILD) systemic sclerosis–related interstitial lung disease in clinical practice and trials.


2019 ◽  
Vol 40 (3) ◽  
pp. 311-318 ◽  
Author(s):  
Gemma Sharp ◽  
Pascale Maynard ◽  
Christine A Hamori ◽  
Jayson Oates ◽  
David B Sarwer ◽  
...  

Abstract Background In the subspecialty of female genital cosmetic procedures, patient satisfaction and quality of life are key outcome measures. As such, valid and reliable patient-reported outcome measures (PROMs) examining these outcomes are essential. Objectives The authors sought to identify and scrutinize all PROMs developed for female patients undergoing genital cosmetic procedures. Methods The authors performed a systematic literature review utilizing MEDLINE, PreMEDLINE, Ebase, Embase, OVID, CINAHL, Cochrane Library, PsycINFO, PubMed, and Google Scholar to identify PROMs developed and validated for utilization in female genital cosmetic procedure patients. Instruments identified were assessed according to international guidelines for health outcome measures development and validation. Results The authors identified 50 outcome questionnaires employed in the female genital cosmetic procedure literature. Of these, 26 were ad hoc instruments (ie, had not been formally developed and tested) and 22 were generic instruments (ie, intended for use in broad groups of people, not only specific patient groups). Only 2 instruments have been validated in a female genital cosmetic procedure patient population. These were the Genital Appearance Satisfaction scale and the Cosmetic Procedure Screening Scale–Labiaplasty. Although both these scales had undergone fairly rigorous psychometric development and validation, both had content limitations. Conclusions There is a lack of specific, valid, and reliable satisfaction and quality-of-life PROMs in the field of female genital cosmetic procedures. Future research should involve the development of such measures to more accurately assess the outcomes and benefits of these procedures.


Author(s):  
Tracy M. Frech ◽  
John M. VanBuren ◽  
Emily Startup ◽  
Shervin Assassi ◽  
Elana J. Bernstein ◽  
...  

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