{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,6]],"date-time":"2026-02-06T01:07:55Z","timestamp":1770340075155,"version":"3.49.0"},"reference-count":33,"publisher":"Springer Science and Business Media LLC","issue":"1","content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Health Qual Life Outcomes"],"published-print":{"date-parts":[[2006,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Background<\/jats:title>\n            <jats:p>Management of pain related to advanced or metastatic cancer, although the availability of several pharmacological and non-pharmacological interventions and the existence of well-known guidelines and protocols, is often difficult and inadequate. Evidence of the relative effectiveness of current options for treating cancer pain from comparative randomized studies is scanty.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>In the context of a wider project, a multicenter, open label, prospective Outcome Research study will be launched in Italy in 2006 to investigate the epidemiology of cancer pain and of its treatments, the quality of analgesic-drug therapy and the effectiveness of alternative analgesic strategies in a large, prospective, unselected cohort of cancer patients using the state-of-the art of patient-reported-outcomes. About 100 Italian centers will recruit 2500 patients with advanced\/progressive\/metastatic cancer with pain (related to the cancer disease) requiring analgesic treatments. Each center is expected to recruit 25 consecutive and eligible patients during the study inception period. Approximately two months will be allowed for subject recruitment and enrollment. Subject evaluation and follow-up will be for 3 months. The effect on outcomes of various therapeutic analgesic options administered by physicians, given the observational approach where patients are not assigned at random to different treatments, will be compared using the propensity score approach, allowing the adjustment for treatment selection bias. Later, after the launch of the observational study and on the basis of results, in specific subsamples of patients and in select centers of the network, a Randomized Controlled Trial will be carried out to formally compare the efficacy of alternative analgesic strategies, with particular emphasis on oral morphine (as comparator) and buprenorphine patch (as experimental arm). Results from the outcome (cohort) and experimental (Randomized Controlled Trial) studies will ensure both the external and internal validity.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1186\/1477-7525-4-7","type":"journal-article","created":{"date-parts":[[2006,2,4]],"date-time":"2006-02-04T14:16:50Z","timestamp":1139062610000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Pain in cancer. An outcome research project to evaluate the epidemiology, the quality and the effects of pain treatment in cancer patients"],"prefix":"10.1186","volume":"4","author":[{"given":"Giovanni","family":"Apolone","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Oscar","family":"Bertetto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Augusto","family":"Caraceni","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Oscar","family":"Corli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Franco","family":"De Conno","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roberto","family":"Labianca","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marco","family":"Maltoni","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mariaflavia","family":"Nicora","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Valter","family":"Torri","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Furio","family":"Zucco","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"the Cancer Pain Outcome Research Study Group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2006,2,2]]},"reference":[{"key":"241_CR1","doi-asserted-by":"publisher","first-page":"70","DOI":"10.3322\/canjclin.50.2.70","volume":"50","author":"N Cherny","year":"2000","unstructured":"Cherny N: The management of cancer pain. Cancer J Clin 2000, 50: 70\u2013116.","journal-title":"Cancer J Clin"},{"key":"241_CR2","volume-title":"Cancer Pain, Assessment and Management","author":"J Hearn","year":"2003","unstructured":"Hearn J, Higginson IJ: Cancer pain epidemiology: a systematic review. In Cancer Pain, Assessment and Management. Edited by: Bruera ED, Portenoy RK. Cambridge University Press; 2003."},{"key":"241_CR3","unstructured":"WHO Cancer Pain Relief: with a Guide to Opioid Availability. 2nd edition. WHO, Geneva, 1996. WHO, Geneva; 1990."},{"key":"241_CR4","doi-asserted-by":"publisher","first-page":"519","DOI":"10.1016\/S0885-3924(03)00068-X","volume":"25","author":"MZ Cohen","year":"2003","unstructured":"Cohen MZ, Easley MK, Ellis C, Hughes B, Ownby K, Rashad BG, Rude M, Taft E, Westbrooks JB: Cancer Pain Management and the JCAHO's Pain Standards. An Institutional Challenge. J Pain Symptom Manage 2003, 25: 519\u2013527. 10.1016\/S0885-3924(03)00068-X","journal-title":"J Pain Symptom Manage"},{"key":"241_CR5","doi-asserted-by":"publisher","first-page":"1262","DOI":"10.1016\/S0140-6736(96)90779-5","volume":"347","author":"C Ripamonti","year":"1996","unstructured":"Ripamonti C, De Conno F, Blumhuber H, Ventafridda V: Morphine for relief of cancer pain. Lancet 1996, 347: 1262\u20131263. 10.1016\/S0140-6736(96)90779-5","journal-title":"Lancet"},{"key":"241_CR6","doi-asserted-by":"publisher","first-page":"1075","DOI":"10.1016\/0140-6736(93)92425-S","volume":"341","author":"M Zenz","year":"1993","unstructured":"Zenz M, Willweber-Strumpf A: Opiophobia and cancer pain in Europe. Lancet 1993, 341: 1075\u20131076. 10.1016\/0140-6736(93)92425-S","journal-title":"Lancet"},{"key":"241_CR7","doi-asserted-by":"publisher","first-page":"254","DOI":"10.1016\/S0885-3924(97)00082-1","volume":"13","author":"S Ahmedzai","year":"1997","unstructured":"Ahmedzai S, Brooks D: Transdermal fentanyl versus sustained-release oral morphine in cancer pain: preference, efficacy and quality of life. J Pain Symptom Manage 1997, 13: 254\u2013261. 10.1016\/S0885-3924(97)00082-1","journal-title":"J Pain Symptom Manage"},{"key":"241_CR8","doi-asserted-by":"publisher","first-page":"150","DOI":"10.1016\/S0149-2918(03)90019-1","volume":"25","author":"R Sittl","year":"2003","unstructured":"Sittl R, Griessinger N, Likar R: Analgesic efficacy and tolerability of transdermal buprenorphine in patients with inadequately controlled chronic pain related to cancer and other disorders: a multicenter, randomized, double blind, placebo controlled trial. Clin Therapeutics 2003, 25: 150\u2013168. 10.1016\/S0149-2918(03)90019-1","journal-title":"Clin Therapeutics"},{"key":"241_CR9","doi-asserted-by":"publisher","first-page":"193","DOI":"10.1163\/156856903321579334","volume":"15","author":"K Bohme","year":"2003","unstructured":"Bohme K, Likar R: Efficacy and tolerability of a new opioid analgesic formulation, buprenorphine transdermal therapeutic sysytem (TDS), in the treatment of patients with chronic pain. A randomised, double-blind, placebo-controlled study. Pain Clinic 2003, 15: 193\u2013202. 10.1163\/156856903321579334","journal-title":"Pain Clinic"},{"key":"241_CR10","volume-title":"Cancer Pain, Assessment and Management","author":"JT Farar","year":"2003","unstructured":"Farar JT, Halpern SD: Understanding clinical trials in pain research. In Cancer Pain, Assessment and Management. Edited by: Bruera ED, Portenoy RK, . Cambridge University Press; 2003."},{"key":"241_CR11","doi-asserted-by":"publisher","first-page":"179","DOI":"10.1191\/0269216305pm1002oa","volume":"19","author":"F De Conno","year":"2005","unstructured":"De Conno F, Ripamanonti C, Brunelli C: Opiods purchase and expenditures in nine western European countries: are we killing off morphines? Palliat Med 2005, 19: 179\u2013184. 10.1191\/0269216305pm1002oa","journal-title":"Palliat Med"},{"key":"241_CR12","doi-asserted-by":"publisher","first-page":"78","DOI":"10.1016\/S0140-6736(03)13819-6","volume":"362","author":"A Chinellato","year":"2003","unstructured":"Chinellato A, Terrazzani G, Walley T, Giusti P: Opioids on Italy: is marketing more powerful than the law? Lancet 2003, 362: 78. 10.1016\/S0140-6736(03)13819-6","journal-title":"Lancet"},{"key":"241_CR13","unstructured":"PAIN.CARE\n[http:\/\/www.paincare.it]"},{"key":"241_CR14","first-page":"137","volume":"20","author":"G Apolone","year":"2004","unstructured":"Apolone G, Mosconi P, Colombo P, Tamburini M: Il dolore nel paziente con cancro: un progetto di ricerca. Ricerca & Pratica 2004, 20: 137\u2013143.","journal-title":"Ricerca & Pratica"},{"key":"241_CR15","unstructured":"PROGETTO \"IL DOLORE NEL PAZIENTE CON CANCRO\"\n[http:\/\/crc.marionegri.it\/cancerpain]"},{"key":"241_CR16","volume-title":"BMJ Books","author":"A Jadat","year":"1998","unstructured":"Jadat A: Randomized Controlled Trials. A user's guide. BMJ Books 1998."},{"key":"241_CR17","doi-asserted-by":"publisher","first-page":"684","DOI":"10.1136\/bmj.299.6694.313","volume":"299","author":"CR Brewin","year":"1989","unstructured":"Brewin CR, Bradley C: Patient preferences and randomised clinical trials. BMJ 1989, 299: 684\u2013685.","journal-title":"BMJ"},{"key":"241_CR18","doi-asserted-by":"publisher","first-page":"1250","DOI":"10.1056\/NEJMe048225","volume":"351","author":"C De Angelis","year":"2004","unstructured":"De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB, International Committee of Medical Journal Editors: Clinical trials registration. a statement from the International Committee of Medical Journal Editors. New Eng J Med 2004, 351: 1250\u20131251. 10.1056\/NEJMe048225","journal-title":"New Eng J Med"},{"key":"241_CR19","doi-asserted-by":"publisher","first-page":"592","DOI":"10.1056\/NEJM199403033300902","volume":"330","author":"CS Cleeland","year":"1994","unstructured":"Cleeland CS, Gonin R, Hatfield AK, Edmonson JH, Blum RH, Stewart JA, Pandya KJ: Pain and its treatments in outpatients with metastatic cancer. N Engl J Med 1994, 330: 592\u2013596. 10.1056\/NEJM199403033300902","journal-title":"N Engl J Med"},{"key":"241_CR20","doi-asserted-by":"publisher","first-page":"757","DOI":"10.7326\/0003-4819-127-8_Part_2-199710151-00064","volume":"127","author":"DB Rubin","year":"1997","unstructured":"Rubin DB: Estimating causal effects from large data sets using propensity scores. Ann Intern Med 1997, 127: 757\u2013763.","journal-title":"Ann Intern Med"},{"key":"241_CR21","doi-asserted-by":"publisher","first-page":"3992","DOI":"10.1200\/JCO.2002.03.083","volume":"20","author":"TJ Iwashyna","year":"2002","unstructured":"Iwashyna TJ, Lamont EB: Effectiveness of adjuvant fluorouracil in clinical practice. A population-based cohort study of elderly patients with stage III colon cancer. J Clin Oncol 2002, 20: 3992\u20133998. 10.1200\/JCO.2002.03.083","journal-title":"J Clin Oncol"},{"key":"241_CR22","doi-asserted-by":"publisher","first-page":"1892","DOI":"10.1200\/JCO.2003.99.238","volume":"21","author":"G Apolone","year":"2003","unstructured":"Apolone G, Cavuto S, Torri V, la Vecchia C: Effectiveness of adjuvant fluorouracil in elderly colon cancer patients. The internal and external validity of non randomized research design. J Clin Oncol 2003, 21: 1892\u20131897. 10.1200\/JCO.2003.99.238","journal-title":"J Clin Oncol"},{"key":"241_CR23","volume-title":"Measurement of pain by subjective report","author":"CS Cleeland","year":"1989","unstructured":"Cleeland CS: Measurement of pain by subjective report. Edited by: Chapman CR, Loeser JD. Issue in pain measurement. New York: Raven Press; 1989."},{"key":"241_CR24","doi-asserted-by":"publisher","first-page":"87","DOI":"10.1016\/0304-3959(95)00156-5","volume":"65","author":"A Caraceni","year":"1996","unstructured":"Caraceni A, Mendoza TR, Mencaglia E, Baratella C, Edwards K, Forjaz MJ, Martini C, Serlin RC, de Conno F, Cleeland CS: A validation study of an Italian version of the Brief Pain Inventory (Breve Questionario per la Valutazione del Dolore). Pain 1996, 65: 87\u201392. 10.1016\/0304-3959(95)00156-5","journal-title":"Pain"},{"key":"241_CR25","doi-asserted-by":"publisher","first-page":"55","DOI":"10.1016\/j.ejca.2005.06.022","volume":"42","author":"M Groenvold","year":"2006","unstructured":"Groenvold M, Petersen MA, Aaronson NK, Arraras JI, Blazeby JM, Bottomley A, Fayers PM, de Graeff A, Hammerlid E, Kaasa S, Sprangers MA, Bjorner JB, for the EORTC Quality of Life Group: The development of the EORTC QLQ-C15-PAL: A shortened questionnaire for cancer patients in palliative care. Eur J Cancer 2006, 42: 55\u201364. 10.1016\/j.ejca.2005.06.022","journal-title":"Eur J Cancer"},{"key":"241_CR26","doi-asserted-by":"publisher","first-page":"1333","DOI":"10.1001\/jama.291.11.1333","volume":"291","author":"ER Viscusi","year":"2004","unstructured":"Viscusi ER, Reynolds L, Chung F, Atkinson LE, Khanna S: Patient-controlled transdermal fentanyl hydrochloride vs intravenous morphine pump for postoperative pain: a randomized controlled trial. JAMA 2004, 291: 1333\u20131341. 10.1001\/jama.291.11.1333","journal-title":"JAMA"},{"key":"241_CR27","volume-title":"Cancer Pain, Assessment and Management","author":"C Sweeney","year":"2003","unstructured":"Sweeney C, Bruera ED: Opioids side effects and management. In Cancer Pain, Assessment and Management. Edited by: Bruera ED, Portenoy RK. Cambridge University Press; 2003."},{"key":"241_CR28","volume-title":"OICP, Progetto 2003. GPA-Net Milano","author":"C Corli","year":"2004","unstructured":"Corli C, Pizzuto M: Il trattamento del dolore nei malati oncologici seguiti in setting di cure non specificatamente palliative. OICP, Progetto 2003. GPA-Net Milano 2004."},{"key":"241_CR29","volume-title":"Patient-reported outcome measures: Use in medical product development to support labeling claims - Draft guidance","author":"FDA-Guidance for Industry","year":"2006","unstructured":"FDA-Guidance for Industry: Patient-reported outcome measures: Use in medical product development to support labeling claims - Draft guidance.\n2006. [http:\/\/www.fda.gov\/cder\/guidance\/5460dft.pdf]"},{"key":"241_CR30","doi-asserted-by":"publisher","first-page":"287","DOI":"10.1016\/S0304-3959(00)00339-0","volume":"88","author":"JT Farrar","year":"2000","unstructured":"Farrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL: Defining the clinically important differences in pain outcomes measures. Pain 2000, 88: 287\u2013294. 10.1016\/S0304-3959(00)00339-0","journal-title":"Pain"},{"key":"241_CR31","doi-asserted-by":"publisher","first-page":"149","DOI":"10.1016\/S0304-3959(01)00349-9","volume":"94","author":"JT Farrar","year":"2001","unstructured":"Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM: Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001, 94: 149\u2013158. 10.1016\/S0304-3959(01)00349-9","journal-title":"Pain"},{"key":"241_CR32","doi-asserted-by":"publisher","first-page":"417","DOI":"10.1016\/j.jpainsymman.2004.01.002","volume":"27","author":"A Caraceni","year":"2004","unstructured":"Caraceni A, Galbiati A, Brunelli C, Gorni G, Martini C, Zecca E, De Conno F: Cancer patient compliance in the self-administration of pain assessment. J Pain Symptom Manage 2004, 27: 417\u2013424. 10.1016\/j.jpainsymman.2004.01.002","journal-title":"J Pain Symptom Manage"},{"key":"241_CR33","volume-title":"Applied regression analysis and other multivariable methods","author":"DG Kleimbaum","year":"1988","unstructured":"Kleimbaum DG, Kupper LL, Muller KE: Applied regression analysis and other multivariable methods. PWS-Kent Publishing Company; 1988."}],"container-title":["Health and Quality of Life Outcomes"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/1477-7525-4-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,8,31]],"date-time":"2021-08-31T19:34:27Z","timestamp":1630438467000},"score":1,"resource":{"primary":{"URL":"https:\/\/hqlo.biomedcentral.com\/articles\/10.1186\/1477-7525-4-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2006,2,2]]},"references-count":33,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2006,12]]}},"alternative-id":["241"],"URL":"https:\/\/doi.org\/10.1186\/1477-7525-4-7","relation":{},"ISSN":["1477-7525"],"issn-type":[{"value":"1477-7525","type":"electronic"}],"subject":[],"published":{"date-parts":[[2006,2,2]]},"assertion":[{"value":"28 July 2005","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"2 February 2006","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"2 February 2006","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}}],"article-number":"7"}}