Cohort profile: indigenous human papillomavirus and oropharyngeal squamous cell carcinoma study - a prospective longitudinal cohort.

PURPOSE: Our aims are to: (1) estimate prevalence, incidence, clearance and persistence of oral human papillomavirus (HPV) infection among Indigenous Australians; (2) identify risk factors associated with oropharyngeal squamous cell carcinoma (OPSCC)-related HPV types (HPV 16 or 18); (3) develop HPV-related health state valuations and; (4) determine the impact on OPSCC and cervical cancers, and the cost-effectiveness of extending publicly-funded HPV vaccination among Indigenous Australians. PARTICIPANTS: Participants were recruited from February 2018 to January 2019. Twelve-month follow-up occurred from March 2019 to March 2020. Participants provided socio-demographic characteristics, health-related behaviours including tobacco and alcohol use and sexual history. Health state preferences in regard to HPV vaccination, knowledge regarding HPV infection, OPSCC and cervical cancer were collected using a two-stage standard gamble approach. Participants provided saliva samples and DNA for microbial genotyping was extracted. FINDINGS TO DATE: Of the 910 participants who were positive for ß-globin at baseline, 35% had any oral HPV infection. The most prevalent HPV types were 13 or 32 (Heck's disease; 23%). The second most prevalent types were associated with OPSCC (HPV 16 or 18; 3.3%). Of the 645 participants who were positive for ß-globin at 12-month follow-up, 43% had any HPV infection. Of these, 33% were HPV types 13 or 32 and 2.5% were HPV 16 or 18. Some 588 participants had ß-globin positive oral samples at baseline and 12-month follow-up. The prevalence of any oral HPV infection increased from 34% at baseline to 44% at 12-month follow-up; due to increases in HPV types 13 or 32 (20% at baseline and 34% at 12-month follow-up). FUTURE PLANS: Further funding will be sought to continue follow-up of this cohort, and to include (after a full medical history) a thorough clinical examination of the external head and neck; a complete oral examination and examination of the oropharynx. Blood tests for early stage OPSCC will also be undertaken.

Prevalence of Oral Human Papillomavirus Infection Among Australian Indigenous Adults.

Importance: Human papillomavirus (HPV) infection is associated with oropharyngeal squamous cell carcinoma. International estimates suggest overall oral HPV prevalence is 7.5%, with prevalence of oral HPV types 16 and 18 being 1.6%; prior Australian estimates suggest oral HPV prevalence is 2.3%, with HPV-16 and HPV-18 being 1.3%. Objectives: To estimate the prevalence of oral HPV infection among Indigenous Australians and to report the prevalence of factors associated with high-risk HPV types (ie, HPV-16 and HPV-18) and HPV types linked with Heck disease (ie, HPV-13 and HPV-32). Design, Setting, and Participants: This cross-sectional study analyzed HPV screening results from saliva samples collected from 1011 Indigenous Australians between February 2018 and January 2019. Data were analyzed from May 2018 to May 2019. Recruitment occurred through Aboriginal Community Controlled Health Organisations in South Australia. Eligibility included identifying as Indigenous, residing in South Australia, and being aged 18 years or older. Main Outcomes and Measures: Saliva samples were collected, with microbial DNA for genotyping extracted. Sociodemographic parameters, health-related behaviors, and sexual history data were collected. Analyses were stratified by sex as well as by HPV types 13 and 32 (Heck disease) and 16 and 18 (high risk of oropharyngeal squamous cell carcinoma). Multivariable analyses were conducted to obtain adjusted odds ratios (ORs). Results: Data were obtained for 910 participants (median [interquartile range] age, 37 [27-51] years); 595 participants (65%) were female and 572 (63%) resided in nonmetropolitan locations. In all, 321 saliva samples (35.3%; 95% CI, 32.2%-38.4%) were positive for oral HPV (106 [33.7%] men; 215 [36.1%] women). The highest prevalence was found for HPV types 13 and 32 (207 [22.7%] total; 60 [19.0%] men; 147 [24.7%] women) followed by HPV types 16 and 18 (30 [3.3%] total; 9 [2.9%] men; 21 [3.5%] women). After multivariable analysis, risk factors associated with HPV types 13 and 32 included nonmetropolitan residential status (OR, 2.06; 95% CI, 1.10-3.88) and not having had a tonsillectomy (OR, 2.74; 95% CI, 1.05-7.16). Among women, having obtained a high school education or less was associated with lower odds of HPV-16 and HPV-18 infection (OR, 0.16; 95% CI, 0.03-0.97). Conclusions and Relevance: Prevalence of oral HPV infection in a large sample of Indigenous Australians was high, with one-third testing positive. The most prevalent HPV types were those associated with Heck disease. The prevalence of HPV types associated with oropharyngeal squamous cell carcinoma exceeded both Australian and international population-level estimates.

Engaging with Indigenous Australian communities for a human papilloma virus and oropharyngeal cancer project; use of the CONSIDER statement.

BACKGROUND: The prevalence of oral HPV infection and HPV-related oropharyngeal squamous cell carcinoma (OPSCC) among Indigenous Australians is unknown. This paper outlines the engagement, consultation and recruitment strategies for a study involving investigation of HPV and OPSCC among Indigenous South Australians, based on the consolidated criteria for strengthening the reporting of health research involving Indigenous Peoples (CONSIDER) statement. METHODS: Initial consultations with all interested Aboriginal Community Controlled Health Organisations (ACCHOs) were done throughout 2014 and 2015. This resulted in a funding application submitted that reflected Indigenous community views and inputs in study design and methodology, and which included nine Indigenous investigators. Once funding was received, community consultation was again undertaken, with six ACCHOs providing structures, strategies and recommendations for how recruitment for participants taking part in the study should be undertaken. Staff were hired (n = 6), with non-Indigenous staff (n = 3) undertaking extensive cultural competency training. An Indigenous Reference Group was established to provide oversight and cultural guidance. Recruitment of Indigenous participants by trained field officers occurred between Feb 2018 and Dec 2018, with n = 1011 recruited. Qualitative records summarising research staff contact with ACCHOs and participants were documented. These records, together with field trip notes, key ACCHO stakeholder reflections and research staff comments, were reviewed to summarise the culturally sensitive strategies that appeared to work most successfully to facilitate ACCHO and participant buy-in. RESULTS: Findings were documented against the CONSIDER statement's research reporting framework of governance: relationships, prioritization, methodologies, participation, capacity, analysis and findings, and dissemination. The apparent success of the community engagement processes were then conceptualised into five domains: (1) engaging with ACCHOs as equal partners very early in the research process; (2) having an Indigenous Reference Group; (3) ACCHOs actively promoting the study; (4) having a flexible agenda responsive to broader environment demands and; (5) including Indigenous capacity building. CONCLUSIONS: Consultation and engagement with all sectors of the Indigenous community are essential in any research, especially a project involving HPV and OPSCC. Enabling local Indigenous staff to provide cultural guidance throughout the research process is helpful. Research that is culturally respectful and in partnership with Indigenous groups can be embraced when the research is collaborative and has clear translational benefits. The CONSIDER statement is a useful checklist against which to assess Indigenous health research processes. In future, the findings may be useful to yield important Aboriginal population estimates for both oral HPV infection and OPSCC. This may serve to convince funding bodies to provide health promotion personnel in the field of oral health, specifically OPSCC, in ACCHOs.

Human Papillomavirus and Oropharyngeal Cancer Among Indigenous Australians: Protocol for a Prevalence Study of Oral-Related Human Papillomavirus and Cost-Effectiveness of Prevention.

BACKGROUND: Oropharyngeal cancer is an important, understudied cancer affecting Aboriginal and Torres Strait Islander Australians. The human papillomavirus (HPV) is a significant risk factor for oropharyngeal cancer. Current generation HPV vaccines are effective against the 2 most common types of high-risk HPVs in cancer (hrHPVs 16/18). OBJECTIVES: This study aims (1) to yield population estimates of oncogenic genotypes of HPV in the mouth and oropharynx of defined Aboriginal and Torres Strait Islander populations; (2) to estimate the proportion of oropharyngeal cancer attributable to HPV among these Australian citizens; (3) to estimate the impact of HPV vaccination as currently implemented on rates of oropharyngeal cancer among Aboriginal and Torres Strait Islander Australians; and (4) taking into account impact on oropharyngeal as well as cervical cancer, to evaluate efficacy and cost-effectiveness of targeted extended HPV vaccination to older ages, among our study population. METHODS: Our study design and operation is straightforward, with minimal impost on participants. It involves testing for carriage of hrHPV in the mouth and oropharynx among 1000 Aboriginal South Australians by simple saliva collection and with follow-up at 12 and 24 months, collection of sexual history at baseline, collection of information for estimating health state (quality-of-life) utilities at baseline, genotyping of viruses, predictive outcome and cost-effectiveness modeling, data interpretation and development of vaccination, and follow-up management strategies driven by the Aboriginal community. RESULTS: Participant recruitment for this study commenced in February 2018 and enrollment is ongoing. The first results are expected to be submitted for publication in 2019. CONCLUSIONS: The project will have a number of important outcomes. Synthesis of evidence will enable generation of estimates of the burden of oropharyngeal cancer among Aboriginal and Torres Strait Islander Australians and indicate the likely effectiveness and cost-effectiveness of prevention. This will be important for health services planning, and for Aboriginal health worker and patient education. The results will also point to important areas where research efforts should be focused to improve outcomes in Aboriginal and Torres Strait Islander Australians with oropharyngeal cancer. There will be a strong focus on community engagement and accounting for the preferences of individuals and the community in control of HPV-related cancers. The project has international relevance in that it will be the first to systematically evaluate prevention of both cervical and oropharyngeal cancer in a high-risk Indigenous population taking into account all population, testing, and surveillance options. REGISTERED REPORT IDENTIFIER: RR1-10.2196/10503.

Accuracy of national key performance indicator reporting from two Aboriginal medical services: potential to underestimate the performance of primary health care.

Objective The aim of the present study was to assess the accuracy of extracting national key performance indicator (nKPI) data for the Online Community Health Reporting Environment for Health Services (OCHREStreams) program using the Pen Computer Systems (Leichhardt, NSW, Australia) Clinical Audit Tool (CAT) from Communicare (Telstra Health Communicare Systems, Perth, WA, Australia), a commonly used patient information management system (PIMS) in Aboriginal primary care. Methods Two Aboriginal Community-Controlled Health Services (ACCHSs) were recruited to the present study. A sample of regular clients aged ≥55 years from each ACCHS was selected and a subset of 13 nKPIs was examined. A manual case note audit of the nKPI subset within Communicare was undertaken by a clinician at each participating ACCHS and acted as a 'gold standard' comparator for three query methods: (1) internal Communicare nKPI reports; (2) PenCS CAT nKPI manual filtering (a third-party data-extraction tool); and (3) nKPI data submitted to the Improvement Foundation qiConnect portal. Results No errors were found in nKPI data extraction from Communicare using the CAT and subsequent submission to the qiConnect portal. However, the Communicare internal nKPI report included deceased clients and past patients, and we can be very confident that deceased clients and past patients are also included in the qiConnect portal data. This resulted in inflation of client denominators and an underestimation of health service performance, particularly for nKPIs recording activity in the past 6 months. Several minor errors were also detected in Communicare internal nKPI reports. Conclusions CAT accurately extracts a subset of nKPI data from Communicare. However, given the widespread use of Communicare in ACCHSs, the inclusion of deceased clients and past patients in the OCHREStreams nKPI data program is likely to have resulted in systematic under-reporting of health service performance nationally. What is known about the topic? There has been limited validation of health data exported via data-extraction tools in Australia. More specifically, there are no current published data describing the accuracy of the CAT in mapping health data extracted from Communicare or the accuracy of internal nKPI reports generated by Communicare. Further, no systematic review has been undertaken to assess the accuracy of the nKPI data submission pathway from PIMSs at the health service level to the OCHREStreams qiConnect portal using the CAT. What does this paper add? The CAT accurately extracts a subset of nKPI data from Communicare and accurately submits this to the qiConnect portal. Minor errors exist in some Communicare internal nKPI reports. The inclusion of deceased clients and past patients in the nKPI reporting system for ACCHSs is likely to have resulted in systematic under-reporting of health service performance nationally through this program. What are the implications for practitioners? The inclusion of deceased clients and past patients in the OCHREStreams nKPI program limits the usefulness of these data for local quality improvement activities and national monitoring of health service performance for participating ACCHSs. The use of the CAT by ACCHSs independently from the OCHREStreams program can enable deceased clients and past patients to be excluded from reports that can provide more accurate nKPI data from Communicare for local quality improvement and planning purposes.