Research Interests and Selected Bibliography

Quality of Life

Dr. Fairclough current research interests include the design and analysis of longitudinal studies of Quality of Life with non-random missing data due to disease morbidity or mortality. She has recently published a book entitled “Design and Analysis of Quality of Life Research in Clinical Trials” and has published over 100 publications on topics related to Quality of Life and psychosocial sequelae of cancer and its therapy in pediatric and adult patients.

Fairclough DL. Design and Analysis of Quality of Life Studies in Clinical Trials. Chapman and Hall/CRC Press, Boca Raton, Florida, 2002.

Cella D, Eton DT, Fairclough DL, et al. ‘What is a clinically meaningful change on the Functional Assessment of Cancer Therapy- Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592. J Clin Epi.35:285-295, 2002.

Sloan J, Aaronson N, Cappelleri J, Fairclough D, Varricchio C, and the Clinical Significance Consensus Meeting Group. Assessing the clinical significance of single items relative to summated scores. Mayo Clinic Proc 2002, in press.

Revicki DA, Osoba D, Fairclough D, Barofsky I, Berzon R, Leidy NK, Rothman M.  Recommendations on health-related quality of life research to support labeling and promotional claims in the United States.  Quality of Life Research 9:887-900, 2000.

Fairclough DL, Fetting JH, Cella D, Wonson W, Moinpour CM. Quality of Life and Quality Adjusted Survival for breast cancer patients receiving Adjuvant Therapy. Quality of Life Research, 8:723-731, 1999.

Fairclough DL. Quality of Life, Cancer Investigation and Clinical Practice. Cancer Investigation. 16: 478-484, 1998.

Fairclough DL, Cella DF. Functional assessment of cancer therapy (FACT-G): non-response to individual questions. Quality of Life Research 1996; 5:321-329.

Fairclough DL, Cella DF. A Cooperative Group Report on Quality of Life Research: Lessons Learned. Eastern Cooperative Oncology Group (ECOG). J Natl Cancer Instit 1996; 40:73-75.


Missing Data in longitudinal studies

In recent years, Dr. Fairclough has been extensively involved in exploring analytic methods for longitudinal studies with non-random missing data. This has included the examination of multiple imputation techniques, mixed-effects selection models and mixture models. As a results of collaborative efforts with major cancer cooperative groups (ECOG, IBCSG) and other consulting responsibilities, she has access to a number of large randomized trials to examine the performance of various methods in realistic settings.

Fairclough DL. Design and Analysis of Quality of Life Studies in Clinical Trials. Chapman and Hall/CRC Press, Boca Raton, Florida, 2002.

Fairclough DL, Peterson H, Chang V. Why are missing quality of life data a problem in clinical trials of therapy for cancer? Stat Med. 1998; 17:667-677.

Troxel AB, Fairclough DL, Curren D, Hahn EA. Statistical Analysis of Quality of Life with missing data in cancer clinical trials. Statistics in Medicine. 1998;17:653-666

Fairclough DL, Peterson HF, Cella D, Bonomi P. Comparison of Several Model-Based Methods for Analyzing Incomplete Quality of Life Data in Cancer Clinical Trials. Stats Med. 1998; 17:781-796.

Fairclough DL. Summary measures and statistics for comparison of quality of life in a clinical trial of cancer therapy. Stat Med 1997;16:1197-1209.

Fairclough DL, Gelber R. "Statistical Issues and Considerations" in Quality of Life and Pharmacoeconomics in Clinical Trials, ed Spliker B., Raven Press, 1996; 427-435.

Fairclough DL. Quality of Life in Cancer Clinical Trials: Now That We Have the Data, What Do We Do? J Appl Stat Sci 1996;4(4):253-269.

Fairclough DL. "Methods of analysis for longitudinal studies of health-related quality of life". In "Quality of Life Assessment in Clinical Trials: Methods and Practice". Ed Staquet MJ, Hayes RD, Fayers PM, Oxford University Press, 1998; 227-248.

Fairclough DL, Schwertman NC. Estimation of a positive definite general dispersion matrix from repeated measures with missing data: A Monte Carlo Comparison of the EM Algorithm, Smoothing, and Use of Complete Data Vectors. J Statist Comput Simul. 1994; 50:21-27.

Psychosocial outcomes in Childhood Cancer:

Dr. Fairclough is currently a member of the Pediatric Adaptation to Pediatric Cancer (PACC) collaboration and directs their Data management and Statistics Core. These investigations include interventions for the mothers and siblings of newly diagnosed pediatric cancer patients, children with cognitive impairments, bereaved mothers, and pediatric oncology nurses. Included in this are methodological investigations of mediational models. Dr. Fairclough also is a co-investigator on several of the Eastern Cooperative Group trials investigating quality of life in patients with advanced cancer.

Sahler OJZ, Varni JW, Fairclough DL, et al. Problem Solving Skills Traing for Mothers of Children with Newly Diagnosed Cancer; A Randomized Trial. J Dev Behav Pediatr 23:77-86,2002.

Elkin TD, Phipps S, Mulhern RK, Fairclough DL. Psychological functioning of adolescent and young adult survivors of pediatric malignancy. Med Pediatr Oncol. 1997;29(6):582-588.

Patenaude AF, Basili L, Fairclough DL, Li FP. Attitudes of 47 mothers of pediatric oncology patients toward genetic testing for cancer predisposition. J Clin Oncol 1996; 14:415-421.

Fairclough DL. The effects of a support group on selected psychosocial outcomes of bereaved parents whose child died from cancer, commentary. J Pediatr Oncol Nurs 1995; 12:59-61.

Waber DP, Tarbell NJ, Fairclough DL, Atmore K, Castro R, Isquith P, Lussier F, Romero I, Carpenter PJ, Schiller M, Sallan SE. Cognitive sequelae of treatment in childhood acute lymphoblastic leukemia: cranial radiation requires an accomplice! J Clin Oncol 1995; 15: 2490-2496.

Phipps S, Fairclough DL, Mulhern RK. Avoidant coping in children with cancer. J Pediatric Psych 1995; 20:217-32.

Mulhern RK, Fairclough DL, Smith B, Douglas SM. Maternal depression, assessment methods and physical symptom affect estimates of depression symptomatology among children with cancer. J Ped Psych 1992; 17:313-326.

Ochs J, Mulhern R, Fairclough DL, Parvey L, Whitaker J, Ch'ien L, Mauer A, Simone J. Comparison of neuropsychologic functioning and clinical indicators of neurotoxicity in long-term survivors of childhood leukemia given cranial radiation or parenteral methotrexate: A prospective study. J Clin Oncol 1991; 9:145-151.

Mulhern RK, Fairclough DL, Ochs J. A prospective comparison of neuropsychological performance of children surviving leukemia who received 18 Gy; 24 Gy or no cranial irradiation. J Clin Oncol 1991; 9:1348-1356.