Abstract
The UK Medical Research Council (MRC) Daily Diary Card for quality of life (QOL) assessment was first designed over ten years ago, and since then has been in continuous use in cancer clinical trials organized by the MRC Cancer Trials Office. However, clinical trials using this technique have only reached maturity since 1989 and later. Thus it is timely to review the experiences gained by use of this method of assessing QOL. Results from a series of clinical trials confirm that the Daily Diary Card appears to be a valid, reliable and sensitive instrument which is able to detect the transient changes in health and QOL which occur on a day to day basis during therapy for cancer. However, in early studies we also encountered a number of problems which were addressed during later MRC trials; we belleve that many of these are of general importance to any investigation of QOL in patients, many of the issues raised remain controversial, and the practical lessons learned from applying the Diary Card will be of relevance to those planning future studies of QOL assessment.
Similar content being viewed by others
References
Fayers PM, Jones DR. Measuring and analysing quality of life in cancer clinical trials: a review.Stat Med 1983;2: 429–446.
Bleehen NM, Fayers PM, Girling DJ, Stephens RJ. Survival, adverse reactions and quality of life during combination chemotherapy compared with selective palliative treatment for small-cell lung cancer. Report to the Medical Research Council by its Lung Cancer Working Party.Respir Med 1989;83: 51–58.
Bleehen NM, Fayers PM, Girling DJ, Stephens RJ. Controlled trial of twelve versus six courses of chemotherapy in the treatment of small-cell lung cancer. Report to the Medical Research Council by its Lung Cancer Working Party.Br J Cancer 1989;59: 584–590.
Fayers PM, Bleehen NM, Girling DJ, Sephens RJ. Assessment of quality of life in small-cell lung cancer using a Daily Diary Card developed by the Medical Research Council Lund Cancer Working Party.Br J Cancer 1991;64: 299–306.
Bleehen NM, Girling DJ, Fayers PM, et al. Inoperable non-small-cell lung cancer (NSCLC): a Medical Research Council randomised trial of palliative radiotherapy with two fractions or ten fractions. Report to the Medical Research Council by its Lung Cancer Working Party.Br J Cancer 1991;63: 265–270.
Bleehen NM, Bolger JJ, Girling DJ, et al. A Medical-Research Council (MRC) randomized trial of palliative radiotherapy with 2 fractions or a single fraction in patients with inoperable non-small-cell lung-cancer (NSCLC) and poor performance status.Br J Cancer 1992;65: 934–941.
Bleehen NM, Girling DJ, Machin D, Stephens RJ. A randomised trial of three or six courses of etoposide cyclophosphamide methotrexate and vincristine or six courses of etoposide and ifosfamide in small cell lung cancer (SCLC). II: Quality of life. Medical Research Council Lung Cancer Working Party.Br J Cancer 1993;68: 1157–1166.
Geddes DM, Dones L, Hill E, et al. Quality of life during chemotherapy for small cell lung cancer: assessment and use of a daily card in a randomized trial.Eur J Cancer 1990;26: 484–492.
Earl HM, Rudd RM, Spiro SG, et al. A randomised trial of planned versus as required chemotherapy in small cell lung cancer: a Cancer Research Campaign trial.Br J Cancer 1991;64: 566–572.
Lee CR, Nicholson PW, Souhami RL, Deshmukh AA. Patient compliance with oral chemotherapy as assessed by a novel electronic technique.J Clin Oncol 1992;10: 1007–1013.
de Haes JCJM, van Knippenberg FCE, Neijt JP. Measuring psychological and physical distress in cancer patients: Structure and application of the Rotterdam Symptom Checklist.Br J Cancer 1990;62: 1034–1038.
Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale.Acta Psychiatr Scand 1983;67: 361–370.
Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology.J Natl Cancer Inst 1993;85: 365–376.
Medical Research Council. Radiotherapy alone or with chemotherapy in the treatment of small-cell carcinoma of the lung. Medical Research Council Lung Cancer Working Party.Br J Cancer 1979;40: 1–10.
Fraser SC, Dobbs HJ, Ebbs SR, et al. Combination or mild single agent chemotherapy for advanced breast cancer? CMF vs epirubicin measuring quality of life.Br J Cancer 1993;67: 402–406.
Fraser SC, Ramirez AJ, Ebbs SR, et al. A daily diary for quality of life measurement in advanced breast cancer trials.Br J Cancer 1993;67: 341–346.
Lindley CM, Hirsch JD, O'Neill CV, et al. Quality of life consequences of chemotherapy-induced emesis.Qual Life Res 1992;1: 331–340.
Archer LNJ, Simpson H. Nigh cough counts and diary card scores in asthma.Arch Dis Child 1985;60: 473–474.
Machin D, d'Arcangues C, Busca B, et al. Vaginal bleeding patterns—the problem and an example data set.Appl Stoch Models Data Anal 1987;3: 27–35.
Aaronson NK, Cull A, Kaasa S, Sprangers MAG. The EORTC modular approach to quality-of-life assessment in oncology.Int J Ment Health 1994;23, 75–96.
Morittu L, Earl HM, Souhami RL, et al. Identification of patients at risk of chemotherapy-induced toxicity.Br J Cancer 1989;59: 801–804.
Stephens RJ, Girling DJ, Machin D. Treatment-related deaths in small cell lung cancer trials: can patients at risk be identified?Lung Cancer (Netherlands) 1994;1: 259–274.
Girling DJ, Hopwood P, Ahmedzai S. Assessing quality of life in palliative oncology.Prog Pall Care 1994;2: 80–86.
Streiner DL, Norman GR.Health Measurement Scales. Oxford: Oxford University Press, 1989.
Ganz PA, Haskell CM, Figlin RA, et al. Estimating the quality of life in a clinical trial of patients with metastatic lung cancer using the Karnofsky performance status and the Functional Living Index-Cancer.Cancer 1988;61: 849–856.
Ganz PA, Figlin RA, Haskell CM, et al. Supportive care versus supportive care and combination chemotherapy in metastatic non-small cell lung cancer. Does chemotherapy make a difference?Cancer 1989;63: 1271–1278.
Zwinderman AH. Statistical analysis of longitudinal quality of life data with missing measurements.Qual Life Res 1992;1: 219–224.
Cook DJ, Guyatt GH, Juniper EF, et al. Interviewer versus self-administered questionnaires in developing a disease-specific, health-related quality of life instrument for asthma.J Clin Epidemiol 1993;46: 529–534.
Bergner M, Bobbit RA, Carter WB, Gilson BS. The Sickness Impact Profile: development and final revision of a health status measure.Med Care 1981;19: 787–805.
Hutchinson TA, Boyd NF, Feinstein AR. Scientific Problems in Clinical Scales, as Demonstrated in the Karnofsky Index of Performance Status.J Chron Dis 1979;32: 661–666.
Aaronson NK. Quality of life assessment in clinical trials: methodologic issues.Control Clin Trials 1989;10 (Suppl): 195S-208S.
Olver IN, Matthews JP, Bishop JF, Smith RA. The roles of patient and observer assessments in anti-emetic trials.Eur J Cancer 1994;30A: 1223–1227.
Osoba D. Lessons learned from measuring health-related quality of life in oncology.J Clin Oncol 1994;12: 608–616.
de Bruin AF, de Witte LP, Stevens F, Diederiks JP. Sickness Impact Profile: the state of the art of a generic functional status measure.Soc Sci Med 1992;35: 1003–1014.
Ware JE Jr, Snow KK, Kosinski M, Gandek B.SF-36 Health Survey Manual and Interpretation Guide. Boston: New England Medical Center, 1993.
Sadura A, Pater J, Osoba D, et al. Quality-of-life assessment: Patient compliance with questionnaire completion.J Natl Cancer Inst 1992;84: 1023–1026.
Begg CB, Carbone PP, Elson PJ, Zelen M. Participation of community hospitals in clinical trials. Analysis of five years of experience in the Eastern Cooperative Oncology Group.New Engl J Med 1982;306: 1076–1080.
Meadows AT, Kramer S, Hopson R, et al. Survival in childhood acute lymphocytic leukaemia: effect of protocol and place of treatment.Cancer Invest 1983;1: 49–55.
Stiller CA, Draper GJ. Treatment centre size, entry to trials, and survival in acute lymphoblastic leukaemia.Arch Dis Child 1989;64: 657–661.
Karjalainen S, Palva I. Do treatment protocols improve end results? A study of survival of patients with multiple myeloma in Finland.Br Med J 1989;299: 1069–1072.
Stiller CA. Centralised treatment, entry to trials and survival.Br J Cancer 1994;70: 352–362.
Bailey KR. Generalizing the results of randomized clinical trials.Control Clin Trials 1994;15: 15–23.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Fayers, P. MRC quality of life studies using a daily diary card—practical lessons learned from cancer trials. Qual Life Res 4, 343–352 (1995). https://doi.org/10.1007/BF01593887
Issue Date:
DOI: https://doi.org/10.1007/BF01593887