Community-randomised controlled trial embedded in the Anishinaabek Cervical Cancer Screening Study: Human papillomavirus self-sampling versus Papanicolaou cytology

BMJ Open

Volumn 6, Issue 10, 2016, Pages

  Zehbe, Ingeborg ^a,b,c   Jackson, Robert ^a,b   Wood, Brianne ^d   Weaver, Bruce ^c   Escott, Nicholas ^c,e   Severini, Alberto ^f   Krajden, Mel ^g   Bishop, Lisa ^b   Morrisseau, Kyla ^b   Ogilvie, Gina ^g,h   Burchell, Ann N ^i,j   Little, Julian ^d  

^a Thunder Bay Regional Research Institute   (Canada)

^b LAKEHEAD UNIVERSITY   (Canada)

^c NORTHERN ONTARIO SCHOOL OF MEDICINE   (Canada)

^d UNIVERSITY OF OTTAWA   (Canada)

^e THUNDER BAY REGIONAL HEALTH SCIENCES CENTRE   (Canada)

^f PUBLIC HEALTH AGENCY OF CANADA   (Canada)

^g BRITISH COLUMBIA CENTRE FOR DISEASE CONTROL   (Canada)

^h UNIVERSITY OF BRITISH COLUMBIA   (Canada)

ⁱ ONTARIO HIV TREATMENT NETWORK   (Canada)

^j UNIVERSITY OF TORONTO   (Canada)

more..

Author keywords

cervical screening; cluster randomized controlled trial; HPV self sampling; Indigenous health; Pap testing

Indexed keywords

ADULT; AGED; ANISHINAABEK CERVICAL CANCER SCREENING STUDY; ARTICLE; CANCER INCIDENCE; CANCER PATIENT; CANCER SCREENING; COMPARATIVE STUDY; CONTROLLED STUDY; DNA DETERMINATION; FEMALE; FOLLOW UP; HEALTH CARE UTILIZATION; HUMAN; MAJOR CLINICAL STUDY; NONHUMAN; OUTCOME ASSESSMENT; PAPANICOLAOU TEST; PRACTICE GUIDELINE; UTERINE CERVIX CANCER; WART VIRUS; AGE DISTRIBUTION; AMERICAN INDIAN; COMPLICATION; EARLY CANCER DIAGNOSIS; HEALTH EDUCATION; ISOLATION AND PURIFICATION; LONGITUDINAL STUDY; MASS SCREENING; MIDDLE AGED; ONTARIO; PAPILLOMAVIRIDAE; PAPILLOMAVIRUS INFECTION; PATIENT ATTITUDE; PROCEDURES; RANDOMIZED CONTROLLED TRIAL; SELF CARE; SPECIMEN HANDLING; STATISTICS AND NUMERICAL DATA; UTERINE CERVIX CARCINOMA IN SITU; UTERINE CERVIX TUMOR; VAGINA SMEAR; WOMEN'S HEALTH;

ADULT; AGE DISTRIBUTION; AGED; CERVICAL INTRAEPITHELIAL NEOPLASIA; EARLY DETECTION OF CANCER; FEMALE; HEALTH EDUCATION; HUMANS; INDIANS, NORTH AMERICAN; LONGITUDINAL STUDIES; MASS SCREENING; MIDDLE AGED; ONTARIO; PAPILLOMAVIRIDAE; PAPILLOMAVIRUS INFECTIONS; PATIENT ACCEPTANCE OF HEALTH CARE; SELF CARE; SPECIMEN HANDLING; UTERINE CERVICAL NEOPLASMS; VAGINAL SMEARS; WOMEN'S HEALTH;

EID: 84991200858     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2016-011754     Document Type: Article

References (46)

1. Ferlay J, Soerjomataram I, Ervik M, et al. GLOBOCAN 2012 v1.0, Cancer incidence and mortality worldwide: IARC CancerBase No. 11. Lyon, France: International Agency for Research on Cancer, 2013. http://globocan.iarc.fr (accessed 21 Jun 2014).
2. Quinn M, Babb P, Jones J, et al. Effect of screening on incidence of and mortality from cancer of cervix in England: evaluation based on routinely collected statistics. BMJ 1999;318:904-8.
3. Moore SP, Antoni S, Colquhoun A, et al. Cancer incidence in indigenous people in Australia, New Zealand, Canada and the USA: a comparative population-based study. Lancet Oncol 2015;16:1483-92.
4. Marrett LD, Chaudhry M. Cancer incidence and mortality in Ontario First Nations,1968 1991. Cancer Cause Control 2003;14:259-68.
5. Demers A, Kliewer E, Remes O, et al. Cervical cancer among Aboriginal women in Canada (Commentary). CMAJ 2012;18:743-4.
6. Colquhoun A, Jiang Z, Maiangowi G, et al. An investigation of cancer incidence in a First Nations community in Alberta, Canada, 1995-2006. Chronic Dis Can 2010;30:135-40.
7. Vasilevska M, Ross SA, Gesink D, et al. Relative risk of cervical cancer in indigenous women in Australia, Canada, New Zealand, the United States: a systematic review and meta-analysis. J Public Health Policy 2012;33:148-64.
8. Huh WK, Ault KA, Chelmow D, et al. Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Obstet Gynecol 2015;125:330-7.
9. Ogilvie GS, Krajden M, van Niekerk DJ, et al. Primary cervical cancer screening with HPV testing compared to liquid based cytology: results of round 1 of a randomized controlled trial-the HPV FOCAL Study. Br J Cancer 2012;107:1917-24.
10. Verdoodt F, Jentschke M, Hillemanns P, et al. Reaching women who do not participate in the regular cervical cancer screening programme by offering self-sampling kits: a systematic review and meta-analysis of randomised trials. Eur J Cancer 2015;51:2375-85.
11. Arrossi S, Thouyaret L, Herrero R, et al. Effect of self-collection of HPV DNA offered by community health workers at home visits on uptake of screening for cervical cancer (the EMA study): a population-based cluster-randomised trial. Lancet Glob Health 2015;3:e85-94.
12. Zehbe I, Moeller H, Severini A, et al. Feasibility of self-sampling and human papillomavirus testing for cervical cancer screening in First Nation women from northwest Ontario, Canada: a pilot study. BMJ Open 2011;1:e000030.
13. Wood B, Burchell AN, Escott N, et al. Using community engagement to inform and implement a community-randomized controlled trial in the Anishinaabek cervical cancer screening study. Front Oncol 2014;4:27.
14. Flicker S, Travers R, Guta A, et al. Ethical dilemmas in community-based participatory research: recommendations for institutional review boards. J Urban Health 2007;84:478-93.
15. Leykum LK, Pugh JA, Lanham HJ, et al. Implementation research design: integrating participatory action research into randomized controlled trials. Implement Sci 2009;4:69-77.
16. Maar M, Burchell A, Little J, et al. A qualitative study of provider perspectives of structural barriers to cervical cancer screening among First Nations women. Womens Health Issues 2013;23: e319-25.
17. Maar M, Wakewich P, Wood B, et al. Strategies for increasing cervical cancer screening amongst First Nations Communities in northwest Ontario, Canada. Health Care Women Int 2014;6:1-18.
18. Wakewich P, Wood B, Davey C, et al. Colonial legacy and the experience of First Nations women in cervical cancer screening: a Canadian multi-community study. Crit Public Health 2015;26: 368-80.
19. Campbell MK, Elbourne DR, Altman DG, CONSORT Group. CONSORT statement: extension to cluster randomised trials. BMJ 2004;328:702-8.
20. Campbell MK, Piaggio G, Elbourne DR, et al. CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ 2012;345:e5661.
21. Chan A-W, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200-7.
22. Chan AW, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586.
23. Aboriginal Affairs and Northern Development Canada. 2013 Indian Registration System (Communities, Age, Gender) [database]. https://www.aadnc-aandc.gc.ca/eng/1291132820288/1291132853616#stats (accessed 15 Jul 2014).
24. Murphy J, Kennedy EB, Dunn S, et al. Cervical Screening: a guideline for clinical practice in Ontario. J Obstet Gynaecol Can 2012;34:453-8.
25. Stenvall H, Wikström I, Wilander E. High prevalence of oncogenic human papillomavirus in women not attending organized cytological screening. Acta Derm Venereol 2007;87:243-5.
26. Wikstrom I, Stenvall H, Wilander E. Attitudes to self-sampling of vaginal smear for human papillomavirus analysis among women not attending organized cytological screening. Acta Obstet Gynecol Scand 2007;86:720-5.
27. Sanner K, Wikström I, Strand A, et al. Self-sampling of the vaginal fluid at home combined with high-risk HPV testing. Br J Cancer 2009;101:871-4.
28. Gail MH, Mark SD, Carroll RJ, et al. On design considerations and randomization-based inference for community intervention trials. Stat Med 1996;15:1069-92.
29. Cosby RH, Howard M, Kaczorowski J, et al. Randomizing patients by family practice: sample size estimation, intracluster correlation and data analysis. Fam Pract 2003;20:77-82.
30. Redmond C, Colton T. Biostatistics in clinical trials. New York: John Wiley and Sons Ltd, 2008:56.
31. Giraudeau B, Ravaud P. Preventing bias in cluster randomised trials. PLoS Med 2009;6:e1000065.
32. Hahn S, Puffer S, Torgerson DJ, et al. Methodological bias in cluster randomised trials. BMC Med Res Methodol 2005;5:10.
33. White IR, Carpenter J, Horton NJ. Including all individuals is not enough: lessons for intention-to-treat analysis. Clin Trials 2012;9:396-407.
34. Jo B, Asparouhov T, Muthén BO. Intention-to-treat analysis in cluster randomized trials with noncompliance. Stat Med 2008;27: 5565-77.
35. Rossi PG. Screening: the information individuals need to support their decision: per protocol analysis is better than intention-to-treat analysis at quantifying potential benefits and harms of screening. BMC Medical Ethics 2014;15:28.
36. Davison AC, Hinkley DV. Bootstrap methods and their application. Chapter 5. Cambridge, UK: Cambridge University Press, 1997.
37. Gray NM, Sharp L, Cotton SC, et al. 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. Qual Life Res 2005;14:1553-62.
38. Rosen NO, Knaüper B, Di Dio P. The impact of intolerance of uncertainty on anxiety after receiving an informational intervention about HPV: a randomised controlled study. Psychol Health 2010;25:651-68.
39. Campbell I. Chi-squared and Fisher-Irwin tests of two-by-two tables with small sample recommendations. Stat Med 2007;26:3661-75.
40. Howell D. Treatment of ordered variables in a contingency table. 2007. http://www.uvm.edu/~dhowell/methods7/Supplements/OrdinalChiSq.html (accessed 24 Apr 2015).
41. Germain MF, Costa R, Kelly-Scott K. 2006 Aboriginal population profile for Thunder Bay (component of statistics canada catalogue no. 89-638-X no. 2009001). Apr 2009. http://www.statcan.gc.ca/pub/89-638-x/2009001/article/10832-eng.pdf (accessed 26 Jul 2015).
42. Urban Aboriginal Population Study: Environics Institute, 2011. http://www.uaps.ca/wp-content/uploads/2010/02/UAPS-Summary-Final. pdf (accessed 29 Jul 2015).
43. Statistics Canada. Health Fact Sheets (Publication 82-625-X). Household Food Insecurity. 2013. http://www.statcan.gc. ca/pub/82-625-x/2013001/article/11889-eng.htm (accessed 27 Apr 2014).
44. Racey CS, Withrow DR, Gesink D. Self-collected HPV testing improves participation in cervical cancer screening: a systematic review and meta-analysis. Can J Public Health 2013;104: e159-66.
45. Cancer Care Ontario, Toronto: Screening Guidelines 2014. Toronto. https://www.cancercare.on.ca/pcs/screening/cervscreening/screening-guidelines/(accessed 26 Jul 2015).
46. Sameshima P, Slingerland D, Wakewich P, et al. Growing wellbeing through community participatory arts: the Anishinaabek Cervical Cancer Screening Study (ACCSS). The Palgrave Handbook of Global Arts Education. In press.