Qualitative Development and Content Validity of the Non–small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ), A Patient-reported Outcome Instrument

Abstract

<div class="section"> <a class="named-anchor" id="S1"> <!-- named anchor --> </a> <h5 class="section-title" id="d5708623e167">PURPOSE</h5> <p id="P1">To describe the process and results of the preliminary qualitative development of a new symptom-based PRO measure intended to assess treatment benefit in advanced non-small cell lung cancer (NSCLC) clinical trials. </p> </div><div class="section"> <a class="named-anchor" id="S2"> <!-- named anchor --> </a> <h5 class="section-title" id="d5708623e172">METHODS</h5> <p id="P2">Individual qualitative interviews were conducted with adult NSCLC (Stage I–IV) patients in the US. Experienced interviewers conducted concept elicitation (CE) and cognitive interviews using semi-structured interview guides. The CE interview guide was used to elicit spontaneous reports of symptom experiences along with probing to further explore and confirm concepts. Interview transcripts were coded and analyzed by professional qualitative coders using Atlas.ti software, and were summarized by like-content using an iterative coding framework. </p> <p id="P3">Data from the CE interviews were considered alongside existing literature and clinical expert opinion during an item-generation process, leading to development of a preliminary version of the NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ). Three waves of cognitive interviews were conducted to evaluate concept relevance, item interpretability, and structure of the draft items to facilitate further instrument refinement. </p> </div><div class="section"> <a class="named-anchor" id="S3"> <!-- named anchor --> </a> <h5 class="section-title" id="d5708623e179">FINDINGS</h5> <p id="P4">Fifty-one patients (mean age 64.9 [SD=11.2]; 51.0% female) participated in the CE interviews. A total of 1,897 expressions of NSCLC-related symptoms were identified and coded in interview transcripts, representing approximately 42 distinct symptom concepts. A 9-item initial draft instrument was developed for testing in three waves of cognitive interviews with additional NSCLC patients (n=20), during which both paper and electronic versions of the instrument were evaluated and refined. Participant responses and feedback during cognitive interviews led to the removal of 2 items and substantial modifications to others. </p> </div><div class="section"> <a class="named-anchor" id="S4"> <!-- named anchor --> </a> <h5 class="section-title" id="d5708623e184">IMPLICATIONS</h5> <p id="P5">The NSCLC-SAQ is a 7-item PRO measure intended for use in advanced NSCLC clinical trials to support medical product labelling. The NSCLC-SAQ uses a 7-day recall period and verbal rating scales. It was developed in accordance with the FDA’s PRO Guidance and scientific best practices, and the resulting qualitative interview data provide evidence of content validity. The NSCLC-SAQ has been prepared in both paper and electronic administration formats and a tablet computer-based version is currently undergoing quantitative testing to confirm its measurement properties and support FDA qualification. </p> </div>