Use and Misuse of the Consolidated Standards of Reporting Trials (CONSORT) Guidelines to Assess Research Findings: Comment on Coyne, Stefanek, and Palmer (2007)

Psychological Bulletin

Volumn 135, Issue 2, 2009, Pages 173-178

  Kraemer, Helena C ^a   Kuchler, Thomas ^b   Spiegel, David ^a  

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF KIEL   (Germany)

Author keywords

cancer survival; CONSORT; group support; psychosocial oncology; survivorship

Indexed keywords

ARTICLE; BREAST TUMOR; EPIDEMIOLOGY; HUMAN; MORTALITY; NEOPLASM; PRACTICE GUIDELINE; PSYCHOLOGICAL ASPECT; PSYCHOTHERAPY; RANDOMIZED CONTROLLED TRIAL; RESEARCH; STANDARD; STATISTICS; SURVIVAL;

BIAS (EPIDEMIOLOGY); BREAST NEOPLASMS; GUIDELINES AS TOPIC; HUMANS; NEOPLASMS; PSYCHOTHERAPY; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH; SURVIVAL ANALYSIS;

EID: 61849158282     PISSN: 00332909     EISSN: None     Source Type: Journal    
DOI: 10.1037/0033-2909.135.2.173     Document Type: Article

References (55)

1. Acion L., Peterson J.J., Temple S., and Arndt S. Probabilistic index: An intuitive non-parametric approach to measuring the size of treatment effects. Statistics in Medicine 25 (2006) 591-602
2. Altman D.G., and Andersen K. Calculating the number needed to treat for trials where the outcome is time to an event. British Medical Journal 319 (1999) 1492-1495
3. Altman D.G., Schulz K.F., Hoher D., Egger M., Davidoff F., Elbourne D., et al. The revised CONSORT statement for reporting randomized trials: Explanation and elaboration. Annals of Internal Medicine 134 (2001) 663-694
4. Andersen B.L., Farrar W.B., Golden-Kreutz D., Emery C.F., Glaser R., Crespin T., and Carson III W.E. Distress reduction from a psychological intervention contributes to improved health for cancer patients. Brain, Behavior, and Immunity 21 (2007) 953-961
5. Andersen B.L., Farrar W.B., Golden-Kreutz D.M., Glaser R., Emery C.F., Crespin T.R., et al. Psychological, behavioral, and immune changes after a psychological intervention: A clinical trial. Journal of Clinical Oncology 22 (2004) 3570-3580
6. Begg C., Cho M., Eastwood S., Horton R., Moher D., Olkin I., et al. Improving the quality of reporting of randomized controlled trials: The CONSORT statement. JAMA 276 (1999) 637-639
7. Ben-Eliyahu S. The promotion of tumor metastasis by surgery and stress: Immunological basis and implications for psychoneuroimmunology. Brain, Behavior, and Immunity 17 Suppl. 1 (2003) 27-36
8. Berry D.A., Cirrincione C., Henderson I.C., Citron M.L., Budman D.R., Goldstein L.J., et al. Estrogen-receptor status and outcomes of modern chemotherapy for patients with node-positive breast cancer. JAMA 295 (2006) 1658-1667
9. Chan A.W., Hrobjartsson A., Haahr M.T., Gotzsche P.C., and Altman D.G. Empirical evidence for selective reporting of outcome in randomized trials. JAMA 291 (2004) 2457-2465
10. Cohen J. Statistical power analysis for the behavioral sciences (1988), Erlbaum, Hillsdale, NJ
11. Cooper H., and Hedges L.V. The handbook of research synthesis (1994), Russell Sage Foundation, New York
12. Coyne J.C., Stefanek M., and Palmer S.C. Psychotherapy and survival in cancer: The conflict between hope and evidence. Psychological Bulletin 133 (2007) 367-394
13. Cruess D.G., Antoni M.H., McGregor B.A., Kilbourn K.M., Boyers A.E., Alferi S.M., et al. Cognitive-behavioral stress management reduces serum cortisol by enhancing benefit finding among women being treated for early stage breast cancer. Psychosomatic Medicine 62 (2000) 304-308
14. DeAngelis C.D., Drazen J.M., Frizelle F.A., Haug C., Hoey J., Horton R., et al. Is this clinical trial fully registered?. JAMA 293 (2005) 2927-2929
15. Dhabhar F.S., Miller A.H., Stein M., McEwen B.S., and Spencer R.L. Diurnal and acute stress-induced changes in distribution of peripheral blood leukocyte subpopulations. Brain, Behavior, and Immunity 8 (1994) 66-79
16. Fawzy F.I., Canada A.L., and Fawzy N.W. Malignant melanoma: Effect of a brief, structured psychiatric intervention on survival and recurrence at 10-year follow-up. Archives of General Psychiatry 60 (2003) 100-103
17. Fawzy F.I., Fawzy N.W., Hyun C.S., Elasoff R., Guthrie D., Fahey J.L., and Morton D.L. Malignant melanoma: Effects of an early structured psychiatric intervention, coping, and affective state on recurrence and survival 6 years later. Archives of General Psychiatry 50 (1993) 681-689
18. Filipski E., King V.M., Li X., Granda T.G., Mormont M.C., Liu X., et al. Host circadian clock as a control point in tumor progression. Journal of the National Cancer Institute 94 (2002) 690-697
19. Filipski E., Li X.M., and Lévi F. Disruption of circadian coordination and malignant growth. Cancer Causes & Control 17 (2006) 509-514
20. Friedman L.M., Furberg C.D., and DeMets D.L. Fundamentals of clinical trials (1998), Springer, New York
21. Gallo J.J., Bogner H.R., Morales K.H., Post E.P., Lin J.Y., and Bruce M.L. The effect of a primary care practice-based depression intervention on mortality in older adults: A randomized trial. Annals of Internal Medicine 146 (2007) 689-698
22. Grissom R.J. Probability of the superior outcome of one treatment over another. Journal of Applied Psychology 79 (1994) 314-316
23. Grissom R.J., and Kim J.J. Effect sizes for research (2005), Erlbaum, Mahwah, NJ
24. Ilnyckyj A., Farber J., Cheang M., and Weinerman B. A randomized controlled trial of psychotherapeutic intervention in cancer patients. Annals of the Royal College of Physicians and Surgeons of Canada 27 2 (1994) 93-96
25. Kennedy S., Kiecolt-Glaser J.K., and Glaser R. Immunological consequences of acute and chronic stressors: Mediating role of interpersonal relationships. British Journal of Medical Psychology 61 Pt. 1 (1988) 77-85
26. Kissane D.W., Grabsch B., Clarke D.M., Smith G.C., Love A.W., Bloch S., et al. Supportive-expressive group therapy for women with metastatic breast cancer: Survival and psychosocial outcome from a randomized controlled trial. Psycho-Oncology 16 (2007) 277-286
27. Kissane D.W., Love A., Hatton A., Bloch S., Smith G., Clarke D.M., et al. Effect of cognitive-existential group therapy on survival in early-stage breast cancer. Journal of Clinical Oncology 22 (2004) 4255-4260
28. Kogan M.M., Biswas A., Pearl D., Carlson R., and Spiegel D. Effects of medical and psychotherapeutic treatment on the survival of women with metastatic breast carcinoma. Cancer 80 (1997) 225-230
29. equivalent. Psychological Methods 10 (2005) 413-419
30. Kraemer H.C., and Theimann S. How many subjects? Statistical power analysis in research (1987), Sage, Newbury Park, CA
31. Kraemer H.C., Wilson G.T., Fairburn C.G., and Agras W.S. Mediators and moderators of treatment effects in randomized clinical trials. Archives of General Psychiatry 59 (2002) 877-883
32. Kuchler T., Bestmann B., Rappat S., Henne-Bruns D., and Wood-Dauphinee S. Impact of psychotherapeutic support for patients with gastrointestinal cancer undergoing surgery: 10-year survival results of a randomized trial. Journal of Clinical Oncology 25 (2007) 2702-2708
33. Kuchler T., Henne-Bruns D., Rappat S., Graul J., Holst K., Williams J.I., et al. Impact of psychotherapeutic support on gastrointenstinal cancer patients undergoing surgery: Survival results of a trial. Hepato-Gastroenterology 46 (1999) 322-335
34. Landis J.R., and Koch G.G. An application of hierarchical kappa-type statistics in the assessment of majority agreement among multiple observers. Biometrics 33 (1977) 363-374
35. Levy S.M., Herberman R.B., Lee J., Whiteside T., Kirkwood J., and McFeeley S. Estrogen receptor concentration and social factors as predictors of natural killer cell activity in early-stage breast cancer patients: Confirmation of a model. Natural Immunity and Cell Growth Regulation 9 (1990) 313-324
36. Levy S.M., Herberman R.B., Lippman M., D'Angelo T., and Lee J. Immunological and psychosocial predictors of disease recurrence in patients with early-stage breast cancer. Behavioral Medicine 17 2 (1991) 67-75
37. Levy S.M., Herberman R.B., Whiteside T., Sanzo K., Lee J., and Kirkwood J. Perceived social support and tumor estrogen/progesterone receptor status as predictors of natural killer cell activity in breast cancer patients. Psychosomatic Medicine 52 (1990) 73-85
38. Linn M.W., Linn B.S., and Harris R. Effects of counseling for late stage cancer patients. Cancer 49 (1982) 1048-1055
39. Meinert C.L. Clinical trials: Design, conduct, and analysis (1986), Oxford University Press, New York
40. Mormont M.C., and Lévi F. Circadian-system alterations during cancer processes: A review. International Journal of Cancer 70 (1997) 241-247
41. Peto R., Boreham J., Clarke M., Davies C., and Beral V. UK and USA breast cancer deaths down 25% in year 2000 at ages 20-69 years. Lancet 355 (2000) 1822
42. Rennie D. How to report randomized controlled trials: The CONSORT statement. JAMA 276 (1996) 649
43. Richardson J.L., Shelton D.R., Krailo M., and Levine A.M. The effect of compliance with treatment on survival among patients with hematologic malignancies. Journal of Clinical Oncology 8 (1990) 356-364
44. Rosenbaum P.R., and Rubin D.B. The central role of the propensity score in observational studies for causal effects. Biometrika 70 (1983) 41-55
45. Sapolsky R.M., and Donnelly T.M. Vulnerability to stress-induced tumor growth increases with age in rats: Role of glucocorticoids. Endocrinology 117 (1985) 662-666
46. Schedlowski M., Jacobs R., Stratmann G., Richter S., Hadicke A., Tewes U., et al. Changes of natural killer cells during acute psychological stress. Journal of Clinical Immunology 13 2 (1993) 119-126
47. Sephton S.E., Sapolsky R.M., Kraemer H.C., and Spiegel D. Diurnal cortisol rhythm as a predictor of breast cancer survival. Journal of the National Cancer Institute 92 (2000) 994-1000
48. Sephton S., and Spiegel D. Circadian disruption in cancer: A neuroendocrine-immune pathway from stress to disease?. Brain, Behavior, and Immunity 17 (2003) 321-328
49. Smedslund G., and Ringdal G.I. Meta-analysis of the effects of psychosocial interventions on survival time in cancer patients. Journal of Psychosomatic Research 57 (2004) 123-131
50. Spiegel D., Bloom J.R., Kraemer H.C., and Gottheil E. Effect of psychosocial treatment on survival of patients with metastatic breast cancer. Lancet 2 (1989) 888-891
51. Spiegel D., Butler L.D., Giese-Davis J., Koopman C., Miller E., DiMiceli S., et al. Effects of supportive-expressive group therapy on survival of patients with metastatic breast cancer: A randomized prospective trial. Cancer 110 (2007) 1130-1138
52. Spiegel D., and Sephton S.E. Psychoneuroimmune and endocrine pathways in cancer: Effects of stress and support. Seminars in Clinical Neuropsychiatry 6 4 (2001) 252-265
53. Spiegel D., Sephton S.E., Terr A.I., and Stites D.P. Effects of psychosocial treatment in prolonging cancer survival may be mediated by neuroimmune pathways. In: McCann S.M., Sternberg E.M., Lipton J.M., Chrousos G.P., Gold P.W., and Smith C.C. (Eds). Annals of the New York Academy of Sciences: Vol. 840. Neuroimmunomodulation: Molecular aspects, integrative systems, and clinical advances (1998), New York Academy of Sciences, New York 674-683
54. Touitou Y., Lévi F., Bogdan A., Benavides M., Bailleul F., and Misset J.-L. Rhythm alteration in patients with metastatic breast cancer and poor prognostic factors. Journal of Cancer Research and Clinical Oncology 121 (1995) 181-188
55. Wilkinson L., and the Task Force on Statistical Inference. Statistical methods in psychology journals: Guidelines and explanations. American Psychologist 54 (1999) 594-604