Ruth Elwood Martin

Primary cervical cancer screening with HPV testing compared with liquid-based cytology: results of round 1 of a randomised controlled trial – the HPV FOCAL Study

Background:Round 1 data of human papillomavirus (HPV) FOCAL, a three-arm, randomised trial, which aims to establish the efficacy of HPV DNA testing as a primary screen for cervical cancer, are presented.Methods:The three arms are: Control arm – liquid based cytology with atypical squamous cells of unknown significance (ASC-US) triage with hrHPV testing; Intervention Arm – hrHPV at entry with liquid-based cytology (LBC) triage of hrHPV positives, with exit screen at 4 years; Safety check arm – hrHPV at entry with LBC triage of hrHPV positives with exit screen at 2 years.Results:A total of 6154 women were randomised to the control arm and 12 494 to the HPV arms (intervention and safety check). In the HPV arm, the baseline cervical intraepithelial neoplasia (CIN)2+ and CIN3+ rate was 9.2/1000 (95%CI; 7.4, 10.9) and 4.8/1000 (95%CI; 3.6, 6.1), which increased to 16.1/1000 (95%CI 13.2, 18.9) for CIN2+ and to 8.0/1000 (95%CI; 5.9, 10.0) for CIN3+ after subsequent screening of HPV-DNA-positive/cytology-negative women. Detection rate in the control arm remained unchanged after subsequent screening of ASC-US-positive/hrHPV DNA-negative women at 11.0/1000 for CIN2+ and 5.0/1000 for CIN3+.Conclusion:After subsequent screening of women who were either hrHPV positive/cytology negative or ASC-US positive/HPV negative, women randomised to the HPV arms had increased CIN2+ detection compared with women randomised to the cytology arm.

A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial)

BackgroundIn the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome.Methods/DesignHPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the provinces population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive casesDiscussionTo date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5%) were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%). In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%). Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program.Trial RegistrationInternational Standard Randomised Controlled Trial Number Register, ISRCTN79347302

Dysphagia after stroke and its management

Dysphagia is common after stroke, presenting in 55% of all hospital-admitted patients with acute disease, and, depending on the lesion site and volume, can linger as a chronic problem for years.[1][1] It is estimated that every year in Canada there are 21 000 new elderly patients with dysphagia

Primary health care: applying the principles within a community-based participatory health research project that began in a Canadian women’s prison:

Objectives: the purpose of this research was to determine the feasibility of engaging incarcerated women in community-based participatory research and to identify, by and with the women, the health concerns to be addressed. Design: the integration of primary health care, community-based participatory research, a settings approach to health promotion and transformative action research guided the overall design of this study. Participants: Incarcerated women, correctional centre staff and academic researchers participated collaboratively. Setting. The study was conducted in the main short sentence (two years or less) minimum/medium security women’s correctional centre in a Canadian province. Results: In-depth interviews were conducted with 16 incarcerated women; in-depth group interviews were facilitated with 16 correctional centre staff. Twenty-one themes, which emerged from participatory, inductive and content analysis of the data, were presented at a face-to-face meeting attended by 120 incarcerated women, 10 correctional centre staff and 5 academic researchers. Underlying values and principles for the project were identified prior to a discussion of the results. During the course of this meeting, the themes were converged into five major categories: addictions and mental health; HIV, hepatitis and infections; health care in prison; life skills and re-entry into society (including homelessness and housing); and children, family and relationships. Numerous suggestions for health interventions and participatory projects were generated, each relating to one of the five major categories. Conclusions: this study was unique in that, to our knowledge, no other studies have utilized community-based participatory research methods in which incarcerated women played a role in designing the research questions and tools, collecting the data, analyzing the data, interpreting the data and authoring the publications and presentations. This study demonstrated that it is feasible for incarcerated women to engage in developing and utilizing community-based participatory research methods and that these methods can be grounded in a settings approach to whole prison health promotion. (Global Health Promotion, 2009; 16 (4): pp. 43—53)

Report of the 2003 Pan-Canadian Forum on Cervical Cancer Prevention and Control: The recommendations reported herein reflect the decisions of the pan-Canadian forum participants as individual experts and do not necessarily reflect official policies of their respective organizations.

OBJECTIVE To develop evidence-based consensus recommendations on the delivery of cervical cancer screening, human papillomavirus (HPV) education, HPV testing, and the optimal tool for cervical cytology within the Canadian health system. PARTICIPANTS Leading up to a forum held in Ottawa on November 21 and 22, 2003, 254 registrants reviewed position papers through a Web-based discussion group. Experts in program management, clinical practice, epidemiology, public health, economics, and womens health, representing 48 organizations, then participated in the 2-day forum to develop consensus recommendations. EVIDENCE Writing groups prepared position papers on optimal methods for cervical cytology; education concerning HPV; HPV testing in primary screening; HPV testing as a triage tool in cytopathology; and delivery mechanisms for cervical screening. Systematic reviews were the primary source of evidence supplemented by literature searches. CONSENSUS PROCESS Feedback from Web-based discussions was incorporated into consecutive drafts of position papers. At the forum, recommendations and supporting evidence were presented, further debated in small-group sessions, and discussed in a plenary session. Despite divergent professional mandates and opinions, consensus was achieved on 15 recommendations across all areas. Final recommendations were posted to the Web for further input and circulated for written consensus by participants. CONCLUSIONS The recommendations cover the use of new evidence and technologies in cervical cancer prevention in Canada and provide a framework for provision of HPV education, planning the implementation of new cervical screening technologies in Canada, the development of evaluation plans, and new research areas.

Projected Impact of HPV and LBC Primary Testing on Rates of Referral for Colposcopy in a Canadian Cervical Cancer Screening Program

OBJECTIVE To estimate the impact of implementing primary human papilloma virus liquid-based cytology (LBC) screening on four-year rates of referral for colposcopy in the British Columbia screening program. METHODS We used data on referral for colposcopy from an RCT (HPV FOCAL) comparing HPV testing every four years with LBC testing every two years. We also used data from population screening with conventional cytology among women aged 25 to 69. The predicted effect of adoption of either trial protocol on rates of referral for colposcopy was estimated using trial age-specific result and screening result-specific rates weighted by their screening program distribution. The cumulative age-specific rates of referral for colposcopy over four years were calculated. RESULTS Use of HPV testing initially increased rates of referral for colposcopy in the trial, but over four years the cumulative rates of referral were similar to those for LBC except in women aged 25 to 29, in whom a substantial excess persisted. Four-year rates of referral for colposcopy declined with age in women screened with HPV testing, LBC, and conventional cytology. Extrapolating the trial results to the distribution in the provincial screening program, implementation of either HPV or LBC throughout the provincial population would approximately double the current rates of referral for colposcopy. CONCLUSION Compared with LBC screening, primary screening for HPV increased rates of referral for colposcopy only among women aged 25 to 29. In contrast to current practice, referral for colposcopy was largely driven by the trial protocol recommendations for the management of abnormal results and not by which screening test was used.

Effect of Screening With Primary Cervical HPV Testing vs Cytology Testing on High-grade Cervical Intraepithelial Neoplasia at 48 Months: The HPV FOCAL Randomized Clinical Trial

Importance There is limited information about the relative effectiveness of cervical cancer screening with primary human papillomavirus (HPV) testing alone compared with cytology in North American populations. Objective To evaluate histologically confirmed cumulative incident cervical intraepithelial neoplasia (CIN) grade 3 or worse (CIN3+) detected up to and including 48 months by primary HPV testing alone (intervention) or liquid-based cytology (control). Design, Setting, and Participants Randomized clinical trial conducted in an organized Cervical Cancer Screening Program in Canada. Participants were recruited through 224 collaborating clinicians from January 2008 to May 2012, with follow-up through December 2016. Women aged 25 to 65 years with no history of CIN2+ in the past 5 years, no history of invasive cervical cancer, or no history of hysterectomy; who have not received a Papanicolaou test within the past 12 months; and who were not receiving immunosuppressive therapy were eligible. Interventions A total of 19 009 women were randomized to the intervention (n = 9552) and control (n = 9457) groups. Women in the intervention group received HPV testing; those whose results were negative returned at 48 months. Women in the control group received liquid-based cytology (LBC) testing; those whose results were negative returned at 24 months for LBC. Women in the control group who were negative at 24 months returned at 48 months. At 48-month exit, both groups received HPV and LBC co-testing. Main Outcomes and Measures The primary outcome was the cumulative incidence of CIN3+ 48 months following randomization. The cumulative incidence of CIN2+ was a secondary outcome. Results Among 19 009 women who were randomized (mean age, 45 years [10th-90th percentile, 30-59]), 16 374 (8296 [86.9%] in the intervention group and 8078 [85.4%] in the control group) completed the study. At 48 months, significantly fewer CIN3+ and CIN2+ were detected in the intervention vs control group. The CIN3+ incidence rate was 2.3/1000 (95% CI, 1.5-3.5) in the intervention group and 5.5/1000 (95% CI, 4.2-7.2) in the control group. The CIN3+ risk ratio was 0.42 (95% CI, 0.25-0.69). The CIN2+ incidence rate at 48 months was 5.0/1000 (95% CI, 3.8-6.7) in the intervention group and 10.6/1000 (95% CI, 8.7-12.9) in the control group. The CIN2+ risk ratio was 0.47 (95% CI, 0.34-0.67). Baseline HPV-negative women had a significantly lower cumulative incidence of CIN3+ at 48 months than cytology-negative women (CIN3+ incidence rate, 1.4/1000 [95% CI, 0.8-2.4]; CIN3+ risk ratio, 0.25 [95% CI, 0.13-0.48]). Conclusions and Relevance Among women undergoing cervical cancer screening, the use of primary HPV testing compared with cytology testing resulted in a significantly lower likelihood of CIN3+ at 48 months. Further research is needed to understand long-term clinical outcomes as well as cost-effectiveness. Trial Registration isrctn.org Identifier: ISRCTN79347302

Students' experience of prison health education during medical school

Background: Social responsibility and accountability can be important core values in medical education. At the University of British Columbia, undergraduate medical students engage in prison health community service-learning opportunities in regional correctional facilities. Methods: To describe the impact of prison health exposure on pre-clinical medical students, in-depth individual interviews were conducted with individuals who had participated in a prison health medical education program. All interviews were transcribed verbatim, and interpretive descriptive methods were used to inductively derive thematic findings to describe students’ experiences. Results: Major themes emerged as students reported how (1) exposure to incarcerated populations increases students’ insight into issues that diverse marginalized sub-populations encounter; (2) positive interactions with the incarcerated individuals enhances relationship building; (3) collaboration reinforces teamwork skills and (4) community placements garner important learning opportunities within the medical school curriculum. Conclusions: Our findings demonstrated that pre-clinical exposure to incarcerated individuals and prison health education provided a unique setting for medical students to develop an increased sense of social responsibility and accountability.

Homelessness as viewed by incarcerated women: participatory research

PURPOSE The purpose of this paper is to describe the development, by incarcerated women who were members of a prison participatory health research team, of a survey tool regarding homelessness and housing, the survey findings and recommendations for policy. DESIGN/METHODOLOGY/APPROACH A survey was developed by incarcerated women in a minimum/medium security womens prison in Canada. Associations were examined between socio-demographic factors and reports of difficulty finding housing upon release, homelessness contributing to a return to crime, and a desire for relocation to another city upon release. Open-ended questions were examined to look for recurrent themes and to illuminate the survey findings. FINDINGS In total, 83 women completed the survey, a 72 per cent response rate. Of the 71 who were previously incarcerated, 56 per cent stated that homelessness contributed to their return to crime. Finding housing upon release was a problem for 63 per cent and 34 per cent desired relocation to another city upon release. Women indicated that a successful housing plan should incorporate flexible progressive staged housing. RESEARCH LIMITATIONS/IMPLICATIONS The present study focuses only on incarcerated women but could be expanded in future to include men. PRACTICAL IMPLICATIONS Incarcerated women used the findings to create a housing proposal for prison leavers and created a resource database of the limited housing resources for women prison leavers. SOCIAL IMPLICATIONS Lack of suitable housing is a major factor leading to recidivism. This study highlights the reality of the cycle of homelessness, poverty, crime for survival, street-life leading to drug use and barriers to health, education and employment that incarcerated women face. ORIGINALITY/VALUE Housing is a recognized basic determinant of health. No previous studies have used participatory research to address homelessness in a prison population.

Disease detection and resource use in the safety and control arms of the HPV FOCAL cervical cancer screening trial.

Background:The HPV FOCAL Trial is a RCT comparing human papilloma virus (HPV) with Liquid Based Cytology (LBC) screening for cervical cancer. Results are presented for the comparison of the Safety and Control arms after two rounds.Methods:HPV FOCAL included randomisation of women aged 25–65 into the Safety arm, where they were initially screened with HPV and the Control arm, where they received entry screening with LBC, with both arms screened again with LBC at 24 months.Results:There are 6203 (Safety) and 6075 (Control) women included in this analysis. For the Safety vs Control arms, Round 1 screening resulted in increased detection of cervical intraepithelial neoplasia 2 or worse (CIN2+),15.3 vs 10.4 per 1000, RR=1.48 (95%CI=1.08–2.03) and higher colposcopy referral rates, 5.6% vs 3.2%. LBC screening at 24 months resulted in similar colposcopy referral rates, 1.5% vs 1.9%, and decreased CIN2+ detection, 2.0 vs 4.7 per 1000, RR=0.43 (95%CI=0.21–0.88) in the Safety vs Control arms. CIN2+ detection and colposcopy referral rates declined with increasing age in both arms. One round of HPV screening detected similar levels of CIN2+ as two rounds of LBC screening.Interpretation:CIN2+ detection at 2 years was lower in those screened by HPV, indicating an improved 2-year negative predictive value of the HPV test.