Evaluation of the quality of radiotherapy randomized trials for painful bone metastases: Implications for future research design and reporting

Cancer

Volumn 103, Issue 9, 2005, Pages 1976-1981

  Shakespeare, Thomas P ^a,b   Thiagarajan, Anuradha ^a,b   Gebski, Val ^a,b,c  

^a TAN TOCK SENG HOSPITAL   (Singapore)

^b PRIMER Collaboration   (Australia)

^c NHMRC Clinical Trials Centre   (Australia)

Author keywords

Bone metastases; Dose fractionation; Double blind method; Metaanalysis; Pain; Palliative care; Radiotherapy; Random allocation; Randomized controlled trials; Research design

Indexed keywords

ARTICLE; BONE METASTASIS; BONE PAIN; CANCER PALLIATIVE THERAPY; CANCER RADIOTHERAPY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; HUMAN; META ANALYSIS; PRIORITY JOURNAL; QUALITY CONTROL; RADIATION DOSE FRACTIONATION; RANDOMIZED CONTROLLED TRIAL; RETREATMENT; SCORING SYSTEM; SYSTEMATIC REVIEW;

BONE NEOPLASMS; DOUBLE-BLIND METHOD; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PAIN; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN;

EID: 17644371647     PISSN: 0008543X     EISSN: None     Source Type: Journal    
DOI: 10.1002/cncr.20993     Document Type: Article

References (39)

1. Wu JS-Y, Wong R, Johnston M, Bezjak A, Whelan T. Meta-analysis of dose-fractionation radiotherapy trials for the palliation of painful bone metastases. Int J Radiat Oncol Biol Phys. 2003;55:594-605.
2. Sze WM, Shelley MD, Held I, Wilt TJ, Mason MD. Palliation of metastatic bone pain: single fraction versus multifraction radiotherapy-a systematic review of randomized trials. Clin Oncol. 2003;15:345-352.
3. Ratanatharathorn V, Powers WE, Moss WT, Perez CA. Bone metastasis: review and critical analysis of random allocation trials of local field treatment. Int J Radiat Oncol Biol Phys. 1999;44:1-18.
4. Khan KS, Daya S, Jadad AR. The importance of quality of primary studies in producing unbiased systematic reviews. Arch Intern Med. 1996;156:661-666.
5. Shakespeare, Lu JJ, Back MF, Liang S, Mukherjee RK, Wynne CJ. Patient preference for radiotherapy fractionation schedule in the palliation of painful bone metastases. J Clin Oncol. 2003;21:2156-2162.
6. Steenland E, Leer JW, van Houwelingen H, et al. The effect of a single fraction compared to multiple fractions on painful bone metastases: a global analysis of the Dutch Bone Metastasis Study. Radiother Oncol. 1999;52:101-109.
7. van der Linden YM, Lok JJ, Steenland E, et al. Single fraction radiotherapy is efficacious: a further analysis of the Dutch Bone Metastasis Study controlling for the influence of retreatment. Int J Radiat Oncol Biol Phys. 2004;59:528-537.
8. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Controlled Clin Trials. 1996;17:1-12.
9. Gaze MN, Kelly CG, Kerr GR, et al. Pain relief and quality of life following radiotherapy for bone metastases: a randomized trial of two fractionation schedules. Radiother Oncol. 1997;45:109-116.
10. Ozsaran Z, Yalman D, Anacak Y, Esassolak A, Haydaroglu A. Palliative radiotherapy in bone metastases: results of a randomized trial comparing three fractionation schedules. J Balkan Union Oncol. 2001;6:43-48.
11. Bone Pain Trial Working Party. 8 Gy single fraction radiotherapy for the treatment of metastatic skeletal pain: randomized comparison with a multifraction schedule over 12 months of patient follow-up. Radiother Oncol. 1999:52:111-121.
12. Nielsen OS, Bentzen SM, Sandberg E, Gadeberg CC, Timothy AR. Randomized trial of single dose versus fractionated palliative radiotherapy of bone metastases. Radiother Oncol. 1998;47:233-240.
13. Price P, Hoskin PJ, Easton D, Austin D, Palmer SG, Yarnold JR. Prospective randomized trial of single and multifraction radiotherapy schedules in the treatment of painful bony metastases. Radiother Oncol. 1986;6:247-255.
14. Sarkar SK, Sarkar S, Pahari B, Majumdar D. Multiple and single fraction palliative radiotherapy in bone secondaries-a prospective study. Indian J Radiol Imaging. 2002;12:281-284.
15. Cole DJ. A randomized trial of a single treatment versus conventional fractionation in the palliative radiotherapy of painful bone metastases. Clin Oncol. 1989;1:59-62.
16. Niewald M, Tkocz HJ, Abel U, et al. Rapid course radiation therapy vs. more standard treatment: a randomized trial for bone metastases. Int J Radiat Oncol Biol Phys. 1996;36:1085-1089.
17. Salazar OM, Sandhu T, da Motta NW, et al. Fractionated half-body irradiation (HBI) for the rapid palliation of widespread, symptomatic, metastatic bone disease: a randomized phase III trial of the International Atomic Energy Agency (IAEA). Int J Radiat Oncol Biol Phys. 2001;50:765-775.
18. Hoskin PJ, Price P, Easton D, et al. A prospective randomized trial of 4 Gy or 8 Gy single doses in the treatment of metastatic bone pain. Radiother Oncol. 1992;23:74-78.
19. Madsen EL. Painful bone metastasis: efficacy of radiotherapy assessed by the patients: a randomized trial comparing 4 Gy × 6 versus 10 Gy × 2. Int J Radiat Oncol Biol Phys. 1983;9:1775-1779.
20. Jeremic B, Shibamato Y, Acimovic L, et al. A randomized trial of three single-dose radiation therapy regimens in the treatment of metastatic bone pain. Int J Radiat Oncol Biol Phys. 1998;42:161-167.
21. Okawa T, Kita M, Goto M, Nishijima H, Miyaji N. Randomized prospective clinical study of small, large and twice-a-day fraction radiotherapy for painful bone metastases. Radiother Oncol. 1988;13:99-104.
22. Rasmusson B, Vejborg I, Jensen AB, et al. Irradiation of bone metastases in breast cancer patients: a randomized study with 1 year follow-up. Radiother Oncol. 1995;34:179-184.
23. Tong D, Gillick L, Hendrickson FR. The palliation of symptomatic osseous metastases: final results of the study by the Radiation Therapy Oncology Group. Cancer. 1982;50:893-899.
24. Poulter CA, Cosmatos D, Rubin P, et al. A report of RTOG 8206: a phase III study of whether the addition of single dose hemibody irradiation to standard fractionated local field irradiation is more effective than local field irradiation alone in the treatment of symptomatic osseous metastases. Int J Radiat Oncol Biol Phys. 1992;23:207-214.
25. Roos DE, Fisher RJ. Radiotherapy for painful bone metastases: an overview of the overviews. Clin Oncol. 2003;15:342-344.
26. Macbeth F, Overgaard J. Expert reviews, systematic reviews and meta-analyses. Radiother Oncol. 2002;64:233-234.
27. Marcus DM, Sheils W, Johnson MH, et al. External beam irradiation of subfoveal choroidal neovascularization complicating age-related macular degeneration: one-year results of a prospective, double-masked, randomized clinical trial. Arch Ophthalmol. 2001;119:171-180.
28. Jadad AR, McQuay HJ. Meta-analyses to evaluate analgesic interventions: a systematic qualitative review of their methodology. J Clin Epidemiol. 1996;49:235-243.
29. McQuay HJ, Carroll D, Moore RA. Radiotherapy for painful bone metastases: a systematic review. Clin Oncol. 1997;9:150-154.
30. Liberati A, Himel HN, Chalmers TC. A quality assessment of randomized controlled trials of primary treatment of breast cancer. J Clin Oncol. 1986;4:942-951.
31. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. Med J Aust. 1988;148:189-194.
32. Moher D, Schulz KF, Altman DG, for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Lancet. 2001;357:1191-1194.
33. Kagei K, Suzuki K, Shirato H, Nambu T, Yoshikawa H, Irie G. A randomized trial of single and multifraction radiation therapy for bone metastasis: a preliminary report. Gan No Rinsho. 1990;36:2553-2558.
34. Schultz KF, Chalmers I, Grimes DA, et al. Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals. JAMA. 1994;272:125-128.
35. Chow E, Lutz S, Beyene J. A single fraction for all, or an argument for fractionation tailored to fit the needs of each individual patient with bone metastases? Int J Radiat Oncol Biol Phys. 2003;55:565-567.
36. Gorman CA, Garrity JA, Fatourechi V, et al. A prospective, randomized, double-blind, placebo-controlled study of orbital radiotherapy for Graves' ophthalmopathy. Ophthalmology. 2001;108:1523-1534.
37. Devereux CK, Vidaver R, Hafstein MP, et al. Total lymphoid irradiation for multiple sclerosis. Int J Radiat Oncol Biol Phys. 1988;14:197-203.
38. Pilepich MV, Sicard GA, Breaux SR, Etheredge EE, Blum J, Anderson CB. Renal graft irradiation in acute rejection. Transplantation. 1983;35:208-211.
39. Levitt SH, Aeppli D, Nierengarten MB. Evidence-based medicine: its effect on treatment recommendations as illustrated by the changing role of postmastectomy irradiation to treat breast cancer. Int J Radiat Oncol Biol Phys. 2003;55:645-650.