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However, no validated voice script for interviewer-led telephone administration was previously available. The aim of this study was to develop a voice script for interviewer administration via telephone.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Following guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Mixed Modes Good Research Practices Task Force, a randomised cross-over equivalence study, including cognitive debriefing, was conducted to assess equivalence between paper and telephone administration modes. Assuming an expected intraclass correlation coefficient (ICC) of 0.70 and a minimally acceptable level of 0.50, a sample size of 63 was required.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Cognitive interviews with five cancer patients found the voice script to be clear and understandable. Due to a protocol deviation in the first wave of testing, only 26 patients were available for analyses. A second wave of recruitment was conducted, adding 37 patients (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200963; mean age 55.48; 65.1% female). Total ICCs for mode comparison ranged from 0.72 (nausea and vomiting, 95% CI 0.48\u20130.86) to 0.90 (global health status\/QoL, 95% CI 0.80\u20130.95; pain, 95% CI 0.79\u20130.95; constipation, 95% CI 0.80\u20130.95). For paper first administration, all ICCs were above 0.70, except nausea and vomiting (ICC 0.55; 95% CI 0.24\u20130.76) and financial difficulties (ICC 0.60; 95% CI 0.31\u20130.79). For phone first administration, all ICCs were above 0.70.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The equivalence testing results support the voice script\u2019s validity for administration of the QLQ-C30 via telephone.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s11136-021-02955-6","type":"journal-article","created":{"date-parts":[[2021,7,20]],"date-time":"2021-07-20T14:02:36Z","timestamp":1626789756000},"page":"877-888","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Equivalence testing of a newly developed interviewer-led telephone script for the EORTC QLQ-C30"],"prefix":"10.1007","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3918-1174","authenticated-orcid":false,"given":"Claire","family":"Piccinin","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Madeline","family":"Pe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2289-2113","authenticated-orcid":false,"given":"Dagmara","family":"Kuli\u015b","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James W.","family":"Shaw","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0657-2483","authenticated-orcid":false,"given":"Sally J.","family":"Wheelwright","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Bottomley","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,7,20]]},"reference":[{"key":"2955_CR1","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/85.5.365","author":"NK Aaronson","year":"1993","unstructured":"Aaronson, N. 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Shaw is an employee and shareholder of Bristol-Myers Squibb. All other authors have no financial interests\/personal relationships, which may be considered as potential competing interests, to declare.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study approval was obtained in the United Kingdom (UK) by the Quorum Review independent review board.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"All patients provided written informed consent for their participation.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}