Quality of life assessment of randomized controlled trials

Tumori

Volumn 92, Issue 5, 2006, Pages 373-378

  Panzini, Ilaria ^a   Fioritti, Angelo ^b   Gianni, Lorenzo ^a   Tassinari, Davide ^a   Canuti, Debora ^a   Fabbri, Carla ^a   Rudnas, Britt ^a   Desiderio, Franco ^a   Ravaioli, Alberto ^a  

^a INFERMI HOSPITAL   (Italy)

^b Rimini Public Health Service   (Italy)

Author keywords

Literature review; Quality of life; Randomized controlled clinical trial

Indexed keywords

ARTICLE; CANCER; CANCER PATIENT; CLINICAL PRACTICE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; HEALTH SURVEY; HUMAN; INFORMATION PROCESSING; MEDICAL LITERATURE; ONCOLOGY; OUTCOME ASSESSMENT; PHYSICIAN; PUBLICATION; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; STATISTICAL ANALYSIS; SURVIVAL;

EID: 33845245671     PISSN: 03008916     EISSN: None     Source Type: Journal    
DOI: 10.1177/030089160609200501     Document Type: Article

References (48)

1. Guyatt GH, Sander JO, Feeny D, Patrik DL: Measuring quality of life in clinical trials: a taxonomy and review. CMAJ, 140: 1441-1448, 1989.
2. Beitz J, Gnecco C, Justice R: Quality of life end points in cancer clinical trials. The US Food and Drug Administration perspective. J Natl Cancer Inst, 20: 7-9, 1996.
3. Johnson JR, Temple R: Food and Drug Administration requirements for approval of new anticancer drugs. Cancer Treat Rep, 69: 1155-1159, 1985.
4. Zwinderman HA: Statistical analysis of longitudinal quality of life data with missing measurements. Qual Life Res, 1: 219-224, 1992.
5. Schumacher M, Olschewski M, Schulgen G: Assessment of quality of life in clinical trials. Stat Med, 10: 1915-1930, 1991.
6. Cox DR, Fitzpatrick R, Fletcher AE, Gore SM, Spiegelhalter DJ, Jones DR: Quality of life assessment: can we keep it simple? J R Statist Soc, 155: 353-393, 1992.
7. Nicolucci A, Grilli R, Alexanian AA, Apolone G, Torri V, Liberati A: Quality, evolution, and clinical implications of randomized controlled trials on the treatment of lung cancer. JAMA, 262: 2101-2105, 1989.
8. Schipper H, Clinch J, McMurray A, Levitt M: Measuring the quality of life of cancer patients: The Functional Living Index-Cancer: development and validation. J Clin Oncol, 2: 472-483, 1984.
9. Selby PJ, Chapman JAW, Etazadi-Amoli J, Dalley D, Boyd NF: The development of a method for assessing the quality of life of cancer patients. Br J Cancer, 50: 13-22, 1984.
10. Padilla GV, Presant C, Grant M, Metter G, Lipsett J, Heide F: Quality of life index for patients with cancer. Res Nurs Health, 6: 117-126, 1984.
11. Spitzer WO, Dobson AJ, Hall J, Chesterman E, Levi J, Shepherd R, Battista RN, Catchlove BR: Measuring the quality of life of cancer patients. A concise QL-index for use by physicians. J Chron Dis, 34: 595-597, 1981.
12. Aaronson NK, Bullinger M, Ahmedzai S: A modular approach to quality-of-life assessment in cancer clinical trials. Recent Results Cancer Res, 111: 231-249, 1988.
13. De Haes J: Measuring psychological and physical distress in cancer patients: structure and application of the Rotterdam Symptoms Check List. Br J Cancer, 62: 1034-1038, 1990.
14. Zigmond A: The Hospital Anxiety and Depression Scale. Acta Psychol Scand, 67: 361-370, 1983.
15. Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G: Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol, 15: 974-986, 1997.
16. Ferrell B, Wisdom C, Wenzl C, Brown J: Effects of controlled-released morphine on quality of life for cancer pain. Oncol Nurs Forum, 16: 521-526, 1989.
17. Della Cuna GR, Pellegrini A, Piazzi M: Effect of methylprednisolone sodium succinate on quality of life in preterminal cancer patients: a placebo-controlled, multicenter study. The Methylprednisolone Preterminal Cancer Study Group. Eur J Cancer Clin Oncol, 25: 1817-1821, 1989.
18. Kiebert GM, Hanneke J, de Haes CJ, Kievit J, van de Velde CJ: Effect of peri-operative chemotherapy on the quality of life of patients with early breast cancer. Eur J Cancer, 26: 1038-1042, 1990.
19. Van Holten-Verzantvoort AT, Zwinderman AH, Aaranson NK, Hermans J, van Emmerik B, van Dam FS, van den Bos B, Bijvoet OL, Cleton FJ: The effect of supportive pamidronate treatment on aspects of quality of life of patients with advanced breast cancer. Eur J Cancer, 27: 544-549, 1991.
20. Beller E, Tattersall M, Lumley T, Levi J, Dalley A, Olver I, Page J, Abdi E, Wynne C, Friedlander M, Boadle D, Wheeler H, Margrie S, Simes RJ: Improved quality of life with megestrol acetate in patients with endocrine-insensitive advanced cancer: a randomized placebo-controlled trial. Australasian Megestrol Acetate Cooperative Study Group. Ann Oncol, 8: 277-283, 1997.
21. Van Andel G, Kurth KH, Rietbroek RL, van de Velde-Muusers JA: Quality of life assessment in patients with hormone-resistant prostate cancer treated with epirubicin or with epirubicin plus medroxy progesterone acetate - is it feasible? Eur Urol, 38: 259-264, 2000.
22. Anderson H, Hopwood P, Stephens RJ, Tatcher N, Cottier B, Nicholson M, Milroy R, Maughan TS, Falk SJ, Bond MG, Burt PA, Connoly CK, McIllmurray MB, Carmichael J: Gemcitabine plus best supportive care (BSC) vs BSC inoperable non-small cell lung cancer - a randomized trial with quality of life as the primary outcome. UK NSCLC Gemcitabine Group. Non-small cell lung cancer. Br J Cancer, 83: 447-453, 2000.
23. Fowler JE Jr; Viadur Study Group: Patient-reported experience with the Viadur 12-month leuprolide implant for prostate cancer. Urology, 58: 430-434, 2001.
24. Sailer M, Fuchs KH, Fein M, Thiede A: Randomized clinical trial comparing quality of life after straight and pouch coloanal reconstruction. Br J Surg, 89: 1108-1117, 2002.
25. Osoba D, Slamon DJ, Burchmore M, Murphy M: Effects on quality of life of combined trastuzumab and chemotherapy in women with metastatic breast cancer. J Clin Oncol, 20: 3106-3113, 2002.
26. Kornblith AB, Herndon JE 2nd, Silverman LR, Demakos EP, Odchimar-Reissig R, Holland JF, Powell BL, DeCastro C, Ellerton J, Larson RA, Schiffer CA, Holland JC: Impact of azacytidine on the quality of life of patients with myelodysplastic syndrome treated in a randomized phase III trial: a Cancer and Leukemia Group B study. J Clin Oncol, 20: 2441-2452, 2002.
27. Kono K, Iizuka H, Sekikawa T, Sugai H, Takahashi A, Fujii H, Matsumoto Y: Improved quality of life with jejunal pouch reconstruction after total gastrectomy. Am J Surg, 185: 150-154, 2003.
28. Oefelein MG, Bayazit Y: Chronic pain syndrome after laparoscopic radical nephrectomy. J Urol, 70: 1939-1940, 2003.
29. Fisch MJ, Titzer ML, Kristeller JL, Shen J, Loehrer PJ, Jung SH, Passik SD, Einhorn LH: Assessment of quality of life in outpatients with advanced cancer: the accuracy of clinician estimations and the relevance of spiritual well-being - a Hoosier Oncology Group Study. J Clin Oncol, 21: 2754-2759, 2003.
30. Wong GY, Schroeder DR, Carns PE, Wilson JL, Martin DP, Kinney MO, Mantilla CB, Warner DO: Effect of neurolytic celiac plexus block on pain relief, quality of life, and survival in patients with unresectable pancreatic cancer: a randomized controlled trial. JAMA, 291: 1092-1099, 2004.
31. Pistevou-Gompaki K, Kouloulias VE, Varveris C, Mystakidou K, Georgakopoulos G, Eleftheriadis N, Gompakis N, Kouvaris J: Radiotherapy plus either transdermal fentanyl or paracetamol and codeine for painful bone metastases: a randomised study of pain relief and quality of life. Curr Med Res Opin, 20: 159-163, 2004.
32. Piao BK, Wang YX, Xie GR, Mansmann U, Matthes H, Beuth J, Lin HS: Impact of complementary mistletoe extract treatment on quality of life in breast, ovarian and non-small cell lung cancer patients. A prospective randomized controlled clinical trial. Anticancer Res, 24: 303-309, 2004.
33. Semiglasov VF, Stepula VV, Dudov A, Lehmacher W, Mengs U: The standardised mistletoe extract PS76A2 improves QoL in patients with breast cancer receiving adjuvant CMF chemotherapy: a randomised, placebo-controlled, double-blind, multicentre clinical trial. Anticancer Res, 24: 1293-1302, 2004.
34. Homs MY, Essink-Bot ML, Borsboom GJ, Steyerberg EW, Siersema PD: Quality of life after palliative treatment for oesophageal carcinoma - a prospective comparison between stent placement and single dose brachytherapy. Eur J Cancer, 40: 1862-1871, 2004.
35. Ahles TA, Herndon JE 2nd, Small EJ, Vogelzang NJ, Kornblith AB, Ratain MJ, Stadler W, Palchak D, Marshall ME, Wilding G, Petrylak D, Holland JC: Quality of life impact of three different doses of suramin in patients with metastatic hormone-refractory prostate carcinoma: results of Intergroup O159/Cancer and Leukemia Group B 9480. Cancer, 101: 2202-2208, 2004.
36. Ziolko E, Knopik J, Bucior J, Foltyn W, Jastrzebska-Okon K, Tomczyk A, Kempinski M: Evaluation of the usefulness and effectiveness of anxiolytic therapies in neoplastic diseases. Pol Merkuriusz Lek, 16: 561-564, 2004.
37. Erridge SC, Gaze MN, Price A, Kelly CG, Kerr GR, Cull A, MacDougall RH, Howard GC, Cowie VJ, Gregor A: Symptom control and quality of life in people with lung cancer: a randomised trial of two palliative radiotherapy fractionation schedules. Clin Oncol (R Coll Radiol), 17: 61-67, 2005.
38. MacGregor CA, Canney PA, Patterson G, McDonald R, Paul J: A randomised double-blind controlled trial of oral soy supplements versus placebo for treatment of menopausal symptoms in patients with early breast cancer. Eur J Cancer, 41: 708-714, 2005.
39. Marijnen CA, van de Velde CJ, Putter H, van den Brink M, Maas CP, Martijn H, Rutten HJ, Wiggers T, Kranenbarg EK, Leer JW, Stiggelbout AM: Impact of short-term preoperative radiotherapy on health-related quality of life and sexual functioning in primary rectal cancer: report of a multicenter randomized trial. J Clin Oncol, 23: 1847-1858, 2005.
40. Ringash J, Perkins G, Brierley J, Lockwood G, Islam M, Catton P, Cummings B, Kim J, Wong R, Dawson L: IMRT for adjuvant radiation in gastric cancer: A preferred plan? Int J Radiat Oncol Biol Phys, 63: 732-738, 2005.
41. Wardley A, Davidson N, Barrett-Lee P, Hong A, Mansi J, Dodwell D, Murphy R, Mason T, Cameron D: Zoledronic acid significantly improves pain scores and quality of life in breast cancer patients with bone metastases: a randomised, crossover study of community vs hospital bisphosphonate administration. Br J Cancer, 92: 1869-1876, 2005.
42. Marchin D: Suggestion for the presentation of quality of life data from clinical trial. Stat Med, 17: 711-724, 1998.
43. Curran D, Bacchi M, hsu Schmitz SF, Molenberghs G, Sylvester RJ: Identifying the types of missingness in quality of life data from clinical trials. Stat Med, 17: 739-756, 1998.
44. Tassinari D, Panzini I, Sartori S, Ravaioli A: Surrogate outcomes in quality-of-life research: where will we end up? J Clin Oncol, 21: 1894-1895, 2003.
45. Troxel AB, Fairclough DL, Curran D, Hahn EA: Statistical analysis of quality of life with missing data in cancer clinical trials. Stat Med, 17: 653-666, 1998.
46. Simes RJ, Greatorex V, Gebski VJ: Practical approches to minimize problems with missing quality of life data. Stat Med, 17: 725-737, 1998.
47. Goldhirsch A, Gelber RD, Simes RJ, Glasziou PP, Coates A: Costs and benefits of adjuvant therapy in breast cancer: a quality adjusted survival analysis. J Clin Oncol, 7: 36-44, 1989.
48. Fleming TL, De Mets DL: Surrogate endpoints in clinical trials: are we being misled? Ann Intern Med, 125: 605-613, 1996.