Developing a questionnaire to measure the psychosocial impact of an abnormal cervical smear result and its subsequent management: the TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) trial Article Accepted: 23 December 2004 DOI:
Cite this article as: Gray, N.M., Sharp, L., Cotton, S.C. et al. Qual Life Res (2005) 14: 1553. doi:10.1007/s11136-004-8146-5 Abstract
This paper describes the process of developing and testing a new questionnaire, Process Outcome Specific Measure (POSM), including an assessment of its content validity and reliability. The questionnaire was developed within the context of Trial Of Management of Borderline and Other Low-grade Abnormal smears (TOMBOLA) to assess the psychosocial impact of a low-grade abnormal cervical smear result and the subsequent management. A literature search, focus groups and thorough pre-testing involving experts and patients resulted in a short (15-item), easily completed and understood questionnaire. Questions address issues including cancer, health, fertility and sexual concerns. Repeatability was assessed in 110 TOMBOLA recruits using weighted κ; all but one of the questions showed levels of reliability near to, or above, 0.5. Cronbach’s standardised α was 0.73, indicating acceptable internal consistency. Each POSM item was correlated with the anxiety and depression sub-scales of the Hospital Anxiety Depression Scale (HADS). All except one of the questions correlated more highly with the total POSM score than with the HADS sub-scales thus indicating discriminant validity. The POSM will enable comparison of the alternative management policies for low-grade cervical smears in terms of the benefits (or otherwise) perceived by the women managed by these policies.
Keywords Cervical intraepithelial neoplasia Mass screening Psychological factors Questionnaires References
NHS Cervical Screening Programme. Annual Review 2003 NHS cervical screening programme. Celebrating 15 years of achievement. NHS Cervical Screening Programme, 2003.
NHS Cervical Screening Programme. Colposcopy and programme management. Guidelines for the NHS Cervical Screening Programme. NHS Cervical Screening Programme, 2004.
Sharp, L 2002 How should women with an abnormal cervical smear be followed-up? Scott Cancer Therapy Network Newslett 35 15 17 Google Scholar
Lerman, C, Miller, SM, Scarborough, R, Hanjani, P, Nolte, S, Smith, D. 1991 Adverse psychologic consequences of positive cytologic cervical screening Am J Obstet Gynecol 165 658 662 PubMed Google Scholar
Paskett, ED, Rimer, BK. 1995 Psychosocial effects of abnormal Pap tests and mammograms: A review J Womens Health 4 73 82 Google Scholar
Doherty, IE, Richardson, PH, Wolfe, CD, Raju, KS. 1991 The assessment of the psychological effects of an abnormal cervical smear result and subsequent medical procedures J Psychosom Obstet Gynaecol 12 319 324 Google Scholar
Lamont, J. 1994 Psychosexual reactions of women to the diagnosis of conditions associated with pre-invasive cervical cancer Can J Hum Sex 3 181 183 Google Scholar
Lerman, CE, Rimer, BK. 1993 Psychosocial impact of cancer screening Oncology 7 67 72 Google Scholar
Marteau, TM, Walker, P, Giles, J, Smail, M. 1990 Anxieties in women undergoing colposcopy Br J Obstet Gynaecol 97 859 861 PubMed Google Scholar
Marteau, TM, Kidd, J, Cuddeford, L. 1996 Reducing anxiety in women referred for colposcopy using an information booklet Br J Health Psychol 1 181 189 Google Scholar
Posner, T, Vessey, M. 1988 Psychosexual trauma of an abnormal cervical smear Br J Obstet Gynaecol 95 729 732 PubMed Google Scholar
Roberts, RA, Blunt, SM. 1994 The psychological reaction of women to a colposcopy clinic Br J Obstet Gynaecol 101 751 752 PubMed Google Scholar
Wardle, J, Pernet, A, Stephens, D. 1995 Psychological consequences of positive results in cervical-cancer screening Psychol Health 10 185 194 Google Scholar
Zeisler, H, Mayerhofer, K, Joura, EA, Sator, M, Kainz, C. 1997 Psychological burden of women with mild cervical intraepithelial neoplasia Oncol Rep 4 1063 1065 Google Scholar
Gath, DH, Hallam, N, Mynors-Wallis, L, Day, A, Bond, SAK. 1995 Emotional reactions in women attending a UK colposcopy clinic J Epidemiol Commun Health 49 79 83 Google Scholar
Bell, S, Porter, M, Kitchener, H, Fraser, C, Fisher, P, Mann, E. 1995 Psychological response to cervical screening Prev Med 24 610 616 PubMed Google Scholar
Zigmond, AS, Snaith, RP. 1983 The hospital anxiety and depression scale Acta Psychiatr Scand 67 361 370 PubMed Google Scholar
Bennetts, A, Irwig, L, Oldenburg, B, et al. 1995 PEAPS-Q: A questionnaire to measure the psychosocial effects of having an abnormal pap smear J Clin Epidemiol 1995 1235 1243 Google Scholar
Campion, MJ, Brown, JR, McCance, DJ, et al. 1988 Psychosexual trauma of an abnormal cervical smear Br J Obstet Gynaecol 95 175 181 PubMed Google Scholar
Birch, S, Melnikow, J, Kuppermann, M. 2003 Conservative versus aggressive follow up of mildly abnormal Pap smears: Testing for process utility Health Econ 12 879 884 PubMed Google Scholar
Likert, R. 1952 A technique for the development of attitude scales Educ Psychol Meas 12 313 315 Google Scholar
Sprangers, M, Cull, A, Bjordal, K, Groenvold, M, Aaronson, NK. 1993 The European Organization for Research and Treatment of Cancer approach to quality of life assessment: Guidelines for developing questionnaire modules Qual Life Res 2 287 295 PubMed Google Scholar
The EuroQol Group. EuroQol – A new facility for the measurement of health-related quality of life. Health Policy 1990; 16: 199–208.
SPSS Inc. SPSS for Windows, Release 9.0.0. SPSS Inc, 1999.
Stata Corp. STATA Statistical Software, Release 8.0. Stata Corp, 2003.
Fayers, P, Machin, D. 2000Quality of Life. Assessment, Analysis and Interpretation Wiley Chichester Google Scholar
Streiner, DL, Norman, GR. 2001Health Measurement Scales. A Practical Guide to Their Development and Use Oxford University Press Oxford Google Scholar
Williams, S, Weinman, J, Dale, J, Newman, S. 1996 Expectations: A comparison between general practice patients with and without mood disorder Primary Care Psychiatry 2 229 235 Google Scholar
Cuzick, J, Sasieni, P, Davies, P, et al. 1999 A systematic review of the role of human papillomavirus testing within a cervical screening programme Health Technol Assess 3 i iv Google Scholar
Maissi, E, Marteau, TM, Hankins, M, Moss, S, Legood, R, Gray, A. 2004 Psychological impact of human papillomavirus testing in women with borderline or mildly dyskaryotic cervical smear test results: Cross sectional questionnaire study Br Med J 328 1293 1298 Google Scholar
National Statistics Online. People & Migration. Ethnicity, April 2001. http://www.statistics.gov.uk/cci/nugget.asp? id=764
Blanks, RG, Waller, M, Sanchez-Galvez, A, Moss, SM. 1994 Monitoring and evaluating the performance of the UK NHS Cervial Screening Programme: Monitoring performance by using cytology outcomes adjusted for population characteristics Cytopathology 15 5 11 Google Scholar