Content-balancing strategy in bifactor computerized adaptive patient-reported outcome measurement

2012 ◽  
Vol 22 (3) ◽  
pp. 491-499 ◽  
Author(s):  
Yi Zheng ◽  
Chih-Hung Chang ◽  
Hua-Hua Chang
Author(s):  
Nikunj Patel ◽  
Joshua Maher ◽  
Xandra Lie ◽  
Chad Gwaltney ◽  
Afsaneh Barzi ◽  
...  

Abstract Purpose This study aimed to elucidate the patient experience of hepatocellular carcinoma (HCC) to guide patient-centered outcome measurement in drug development. Methods Patients with HCC participated in qualitative interviews to elicit disease-related signs/symptoms and impacts, using discussion guides developed from literature searches and discussions with oncologists. Interview participants rated the disturbance of their experiences (0–10 scale). A conceptual model was developed and mapped against patient-reported outcome (PRO) instruments identified from database reviews. Results Interviews were conducted with 25 individuals with HCC (68% were men; median age: 63 years; 12% Barcelona clinic liver cancer (BCLC) stage A; 32% stage B; and 56% stage C) in the USA. Fifty-one HCC-related concepts were identified from the interviews and were grouped into eight sign/symptom categories (eating behavior/weight changes; extremities [arms, legs]; fatigue and strength; gastrointestinal; pain; sensory; skin; other) and four impact categories (emotional; physical; cognitive function; other) for the conceptual model. The most prevalent and disturbing experiences across the disease stages were fatigue/lack of energy and emotional impacts such as frustration, fear, and depression. Abdominal pain and skin-related issues were particularly common and disturbing in individuals with HCC stage C. The EORTC QLQ-C30 and HCC18 were identified as commonly used PRO instruments in HCC studies and captured the relevant signs/symptoms associated with the patient experience. Conclusion Patients with HCC reported a range of signs/symptoms and impacts that negatively affect daily functioning and quality of life. Including PRO measures in HCC clinical trials can provide meaningful patient perspectives during drug development.


2019 ◽  
Author(s):  
Christopher B. Forrest ◽  
Katherine B. Bevans ◽  
Ania Filus ◽  
Janine Devine ◽  
Brandon D. Becker ◽  
...  

2017 ◽  
Vol 29 (6) ◽  
pp. 874-879 ◽  
Author(s):  
John Øvretveit ◽  
Lisa Zubkoff ◽  
Eugene C Nelson ◽  
Susan Frampton ◽  
Janne Lehmann Knudsen ◽  
...  

2014 ◽  
Vol 30 (4) ◽  
pp. 879-884 ◽  
Author(s):  
Natália Fontes Caputo de Castro ◽  
Carlos Henrique Alves de Rezende ◽  
Tânia Maria da Silva Mendonça ◽  
Carlos Henrique Martins da Silva ◽  
Rogério de Melo Costa Pinto

O Patient-Reported Outcome Measurement Information System (PROMIS), estruturado em domínios físicos e psicossociais, superou lacunas ao propor nova ferramenta de avaliação de resultados aplicáveis às doenças crônicas com base em técnicas avançadas de estatística (TRI) e testes adaptativos computadorizados (CAT). O objetivo do estudo foi adaptar culturalmente os Bancos de Itens de Ansiedade e Depressão do PROMIS para a língua portuguesa. O processo seguiu rigorosas recomendações do FACIT por meio da tradução avançada, reconciliação, retrotradução, revisão do FACIT, revisores independentes, finalização das etapas pelo FACIT, pré-teste e incorporação dos resultados do pré- teste. A versão traduzida foi pré-testada em dez pacientes, sendo necessária a modificação nos itens 3, 46 e 53 de Ansiedade e no item 46 de Depressão. As alterações alcançaram a equivalência de significado e a versão final foi compatível com as habilidades linguísticas e culturais da população brasileira. Concluiu-se que a versão traduzida é semântica e conceitualmente equivalente aos originais.


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