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At its most elemental, patient-reported outcomes (PRO) assessment involves asking the patients questions and evaluating their answers. Instrument developers need to be clear about what they want to know, from whom they want to know it and why, whether what they learned is credible, and whether they can interpret what they learned in the context of the research objectives. Because credible instrument development is neither inexpensive nor technically trivial, researchers must first determine that no available measure meets their research objectives. We suggest that the tasks of either reviewing current instruments or developing new ones originate from the same basic premise: PRO assessment requires a well-articulated conceptual framework. Once defined in the context of the research objectives, the conceptual framework needs to be adapted to the population of interest. We discuss how qualitative methods enrich the conceptual framework and facilitate the technical measurement tasks of item development, testing, and reduction. We recognize that PRO assessment stands at a technological crossroads with the increasingly frequent application of "modern" psychometric methods and discuss how innovations such as item banks and computer-adaptive testing will influence PRO instrument development. Although items are the essential building blocks for instruments, scales are the primary unit of analysis for PRO assessment, and we discuss methods for scoring and combining them. Finally, PRO assessment is meaningless if the key figure chooses not to cooperate. We consider how respondent burden influences the quality of PRO assessment.

The use of electronic data capture (EDC) to assess health-related quality of life (HRQOL) using validated questionnaires is increasing; however, it must be determined how data collected electronically correlate with the original mode of administration used in validation. Our objective was to compare paper and electronic administration of the standardized Asthma Quality of Life Questionnaire (AQLQ(S)), Pediatric Asthma Quality of Life Questionnaire (PAQLQ(S)), and Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ). Using a crossover design, adults and children with asthma and caregivers of children with asthma were recruited from clinics. Subjects were asked to complete both forms of the appropriate HRQOL measures at enrollment and 24-48 hours later. In addition, 30 subjects from each group were asked to participate in a 1-week reproducibility assessment of the electronic versions of the three questionnaires. Psychometric properties were assessed for each of the EDC versions. Intraclass correlation coefficients (ICC) and Pearson correlations were calculated to compare EDC and paper versions. A total of 51 adults (mean age 37, 73% females), 52 children (mean age 13, 38% females), and 51 caregivers (mean age 43, 92% females) were evaluated. Internal consistency (Cronbach's alpha) for the overall score of each questionnaire was: 0.96 for the AQLQ(S) and the PAQLQ(S), and 0.92 for the PACQLQ. Overall ICCs comparing paper with EDC were: 0.96 for the AQLQ(S), 0.91 for the PAQLQ(S), and 0.82 for the PACQLQ. Pearson's correlations were identical. One-week reproducibility (ICC) of the EDC versions was: 0.88 for the AQLQ(S), 0.78 for the PAQLQ(S), and 0.85 for the PACQLQ. When asked which method subjects preferred, the electronic version was chosen by 69% of adults, 77% of children, and 73% of caregivers. Additionally, 14% of adults, 14% of children, and 18% of caregivers reported no difference in preference. As in previous studies comparing electronic with paper questionnaires, this study revealed statistical evidence to support the use of EDC of the AQLQ(S), PAQLQ(S), and PACQLQ for populations with asthma.

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IntroductionGuidelines for management of non-small cell lung cancer (NSCLC) strongly recommend EGFR mutation testing. These recommendations are particularly relevant in Asians that have higher EGFR mutation prevalence. This study aims to explore current testing practices, logistics of testing, types of EGFR mutation, and prevalence of EGFR mutations in patients with advanced NSCLC in a large comprehensive cancer center in Korea.MethodsOur retrospective cohort included 1,503 NSCLC patients aged ≥18 years, with stage IIIB/IV disease, who attended the Samsung Medical Center in Seoul, Korea, from January 2007 through July 2010. Trained oncology nurses reviewed and abstracted data from electronic medical records.ResultsThis cohort had a mean age (SD) of 59.6 (11.1) years, 62.7% were males, and 52.9% never-smokers. The most common NSCLC histological types were adenocarcinoma (70.5%) and squamous cell carcinoma (18.0%). Overall, 39.5% of patients were tested for EGFR mutations. The proportion of patients undergoing EGFR testing during January 2007 through July 2008, August 2008 through September 2009, and October 2009 through July 2010 were 23.3%, 38.3%, and 63.5%, respectively (P<0.001). The median time elapsed between cancer diagnoses and receiving EGFR testing results was 21 days. EGFR testing was most frequently ordered by oncologists (57.7%), pulmonologists (31.9%), and thoracic surgeons (6.6%). EGFR testing was more commonly requested for women, younger patients, stage IV disease, non-smokers, and adenocarcinoma histology. Of 586 cases successfully tested for EGFR mutations, 209 (35.7%) were positive, including 118 cases with exon 19 deletions and 62 with L858R mutations. EGFR mutation positive patients were more likely to be female, never-smokers, never-drinkers and to have adenocarcinoma.ConclusionsIn a large cancer center in Korea, the proportion of EGFR testing increased from 2007 through 2010. The high frequency of EGFR mutation positive cases warrants the need for generalized testing in Asian NSCLC patients.