{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T07:54:02Z","timestamp":1787730842384,"version":"build-2784847793"},"reference-count":42,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2022,1,14]],"date-time":"2022-01-14T00:00:00Z","timestamp":1642118400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,1,14]],"date-time":"2022-01-14T00:00:00Z","timestamp":1642118400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Support Care Cancer"],"published-print":{"date-parts":[[2022,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>With higher efficacy of cancer therapies, the numbers and types of side effects experienced by patients have also increased, evidencing a need for brief assessments of side effect bother. The Functional Assessment of Cancer Therapy-General (FACT-G) includes the item \u201cI am bothered by side effects of treatment\u201d (GP5). This study aimed to confirm GP5\u2019s validity in a large, diverse, real-world patient sample.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Real-world data were drawn from 10 Adelphi Disease Specific Programmes (DSP\u2122) conducted between 2015 and 2019 in France, Germany, Italy, Spain, the UK and the USA, covering 10 cancer sites. We examined correlations between GP5 responses and varied measures of patient-reported global health and the number of side effects experienced. We explored whether more advanced patients and those with worse Eastern Cooperative Oncology Group Performance Status Rating (ECOG PSR) reported greater side effect bother. Finally, we conducted differential item functioning (DIF) assessment using the Mantel\u2013Haenszel approach.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The sample included 6755 advanced cancer patients. GP5 responses were distributed similarly across most cancer sites. A moderate, negative correlation (<jats:italic>r<\/jats:italic><jats:sub>polyserial<\/jats:sub>\u2009=\u2009\u2009\u2212\u20090.43) between GP5 responses and global health evidenced convergent validity. Known groups validity was evidenced by dichotomised distributions of GP5, showing expected results between cancer stage 2 vs. 3 and 4 and with ECOG PSR (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). Little evidence of DIF was found.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>GP5 exhibited evidence of validity across cancer sites and countries and appeared to measure the same construct across these countries. GP5 has significant promise as a summary indicator of side effect bother.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00520-022-06802-3","type":"journal-article","created":{"date-parts":[[2022,1,14]],"date-time":"2022-01-14T19:02:18Z","timestamp":1642186938000},"page":"3613-3623","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Validity of a single-item indicator of treatment side effect bother in a diverse sample of cancer patients"],"prefix":"10.1007","volume":"30","author":[{"given":"Pip","family":"Griffiths","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John Devin","family":"Peipert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Leith","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex","family":"Rider","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucy","family":"Morgan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Cella","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2595-708X","authenticated-orcid":false,"given":"Kim","family":"Cocks","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,1,14]]},"reference":[{"key":"6802_CR1","doi-asserted-by":"publisher","first-page":"356","DOI":"10.1016\/j.ejca.2018.07.005","volume":"103","author":"J Ferlay","year":"2018","unstructured":"Ferlay J, Colombet M, Soerjomataram I, Dyba T, Randi G, Bettio M, Gavin A, Visser O, Bray F (2018) Cancer incidence and mortality patterns in Europe: estimates for 40 countries and 25 major cancers in 2018. 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JNCCN Volume 9 Number 3","DOI":"10.6004\/jnccn.2011.0026"}],"container-title":["Supportive Care in Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00520-022-06802-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00520-022-06802-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00520-022-06802-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,2,18]],"date-time":"2022-02-18T21:16:46Z","timestamp":1645219006000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00520-022-06802-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,1,14]]},"references-count":42,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2022,4]]}},"alternative-id":["6802"],"URL":"https:\/\/doi.org\/10.1007\/s00520-022-06802-3","relation":{},"ISSN":["0941-4355","1433-7339"],"issn-type":[{"value":"0941-4355","type":"print"},{"value":"1433-7339","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,1,14]]},"assertion":[{"value":"28 April 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"31 December 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"14 January 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Data for this research study were collected via multiple surveys, each conducted in a different cancer site. Data collection was undertaken in line with the European Pharmaceutical Market Research Association (EphMRA) code of conduct. The EphMRA Code of Conduct states that research that meets the definition relating to market or consumer behaviour of the sort that pharmaceutical companies routinely commission, whether involving healthcare professionals, patients, carers or members of the public, does not require Clinical Research Ethics Committee or Independent Review Board approval. Each survey was performed in full accordance with relevant legislation at the time of data collection, including the US Health Insurance Portability and Accountability Act 1996 and the Health Information Technology for Economic and Clinical Health Act legislation.In line with the EphMRA Code of Conduct, ethical approval was not sought for surveys gathering research in breast cancer, NSCLC, prostate cancer and CLL.Although not required, ethical approval was gained via independent review boards for the remaining studies: Western Independent Review Board (WIRB; study in HCC, protocol number AG8522), Freiburg Ethics Commission International (FEKI; studies in Gastric [protocol #AG8194], Melanoma [protocol #AG8036], MM [protocol #7868], FL [protocol #AG8266] and DLBCL [protocol #AG8304]).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"A complete description of the methods of the survey has been previously published and validated [, ]. Using a check box, patients provided informed consent for use of their anonymised and aggregated data for research and publication in scientific journals. Data were collected in such a way that patients and physicians could not be identified directly; all data were aggregated and de-identified before receipt.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate and consent for publication"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}