研究动态
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乡村环境下宫颈癌预防措施的授权模式:一个集群随机交叉试验的方案。

A Model for Empowering Rural Solutions for Cervical Cancer Prevention (He Tapu Te Whare Tangata): Protocol for a Cluster Randomized Crossover Trial.

发表日期:2023 Sep 14
作者: Beverley Lawton, Evelyn Jane MacDonald, Francesca Storey, Jo-Ann Stanton, Anna Adcock, Melanie Gibson, Varsha Parag, Ngaire Kereru Sparkes, Bobby Kaimoana, Frances King, Marion Terry, Huti Watson, Matthew Bennett, Charles Seymour Lambert, Stacie Geller, Isitokia Paasi, Merilyn Hibma, Peter Sykes, David Hawkes, Marion Saville
来源: CLINICAL PHARMACOLOGY & THERAPEUTICS

摘要:

毛利人是奧特羅亞(新西蘭)的土著民族。儘管全球普遍認可子宮頸癌幾乎完全可以通過疫苗接種和篩查預防,但比起非毛利婦女,毛利婦女更容易患上子宮頸癌,且死亡率是她們的2.5倍。被診斷患有子宮頸癌的鄉村毛利居民的預後比城市居民更糟糕。在體驗到距離、缺乏社區資源以及健康系統和政府對鄉村需求的低優先級所導致的到恰當和及時的醫療保健存在著障礙方面,住在奧特羅亞的鄉村意味著面臨到複雜化的困境。目前的篩查程序和轉診途徑在每個步驟中均會引起延遲,這進一步加劇了這些障礙。高風險人類乳頭瘤病毒(hrHPV)篩查和點對點(POC)測試是全球預防子宮頸癌的科學進展。這項研究旨在比較社區控制途徑和標準護理對hrHPV檢測後的篩查接受性、可行性、及時性和進行子宮頸鏡檢查的轉診和出席情況。這是一項叢集隨機交叉試驗,有2個主要的初級保健實踐(研究地點)作為叢集。每個地點被隨機分派實施途徑1或2,15個月後交叉。途徑1(社區控制途徑)包括HPV自測、1小時POC結果、面對面的信息、支持和對陽性測試結果的立即轉診進行子宮頸鏡檢查。途徑2(標準護理)包括HPV自測、實驗室分析、常規結果提供、信息、支持和陽性測試結果的標準轉診途徑。主要結果是hrHPV陽性結果中,在HPV測試後的20個工作日內接受子宮頸鏡檢查的婦女比例(國家績效指標)。定性研究將從治理團體、臨床人員、婦女及其家庭的角度分析這兩種途徑的成功和挑戰。這些信息將直接為新的全國子宮頸癌篩查計劃提供指導。在首個15個月的期間,進行了743個符合標準的HPV自測:其中370個是在途徑1進行的同時進行POC測試,373個則是在途徑2進行的同時進行實驗室測試。hrHPV的陽性率為7.3%(54/743)。第二期數據收集、質性訪談和分析尚在進行中。這項以毛利為中心的研究結合了定量和定性研究,比較了從檢測到子宮頸鏡檢查的2種臨床途徑。該協議充分利用了鄉村社區實踐的優勢,成功地通過面對面的方式、非臨床社區衛生工作者和多個干預場所,接觸到毛利人,以推動傳統的家庭健康方法(whānau ora)、培養健康的文化氛圍。它將為理論和實踐提供基礎,探討使用創新技術的鄉村模式,解決毛利人子宮頸癌不平等問題,促進毛利人的健康。預計研究結果將適用於其他高收入國家的土著和鄉村人口。澳大利亞新西蘭臨床試驗登記庫(ANZCTR)ACTRN12621000553875; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12621000553875.©Beverley Lawton, Evelyn Jane MacDonald, Francesca Storey, Jo-Ann Stanton, Anna Adcock, Melanie Gibson, Varsha Parag, Ngaire Kereru Sparkes, Bobby Kaimoana, Frances King, Marion Terry, Huti Watson, Matthew Bennett, Charles Seymour Lambert, Stacie Geller, Isitokia Paasi, Merilyn Hibma, Peter Sykes, David Hawkes, Marion Saville. 原始刊登於JMIR Research Protocols (https://www.researchprotocols.org),日期14.09.2023.
Māori are the Indigenous people of Aotearoa (New Zealand). Despite global acceptance that cervical cancer is almost entirely preventable through vaccination and screening, wāhine Māori (Māori women) are more likely to have cervical cancer and 2.5 times more likely to die from it than non-Māori women. Rural Māori residents diagnosed with cervical cancer have worse outcomes than urban residents. Living in rural Aotearoa means experiencing barriers to appropriate and timely health care, resulting from distance, the lack of community resourcing, and low prioritization of rural needs by the health system and government. These barriers are compounded by the current screening processes and referral pathways that create delays at each step. Screening for high-risk human papillomavirus (hrHPV) and point-of-care (POC) testing are scientific advances used globally to prevent cervical cancer.This study aims to compare acceptability, feasibility, timeliness, referral to, and attendance for colposcopy following hrHPV detection between a community-controlled pathway and standard care.This is a cluster randomized crossover trial, with 2 primary care practices (study sites) as clusters. Each site was randomized to implement either pathway 1 or 2, with crossover occurring at 15 months. Pathway 1 (community-controlled pathway) comprises HPV self-testing, 1-hour POC results, face-to-face information, support, and immediate referral to colposcopy for women with a positive test result. Pathway 2 (standard care) comprises HPV self-testing, laboratory analysis, usual results giving, information, support, and standard referral pathways for women with a positive test result. The primary outcome is the proportion of women with hrHPV-positive results having a colposcopy within 20 working days of the HPV test (national performance indicator). Qualitative research will analyze successes and challenges of both pathways from the perspectives of governance groups, clinical staff, women, and their family. This information will directly inform the new National Cervical Screening Program.In the first 15-month period, 743 eligible HPV self-tests were performed: 370 in pathway 1 with POC testing and 373 in pathway 2 with laboratory testing. The positivity rate for hrHPV was 7.3% (54/743). Data collection for the second period, qualitative interviews, and analyses are ongoing.This Māori-centered study combines quantitative and qualitative research to compare 2 clinical pathways from detection of hrHPV to colposcopy. This protocol draws on rural community practices strengths, successfully engaging Māori from a whānau ora (family wellness) approach including kanohi ki te kanohi (face-to-face), kaiāwhina (nonclinical community health workers), and multiple venues for interventions. It will inform the theory and practice of rural models of the use of innovative technology, addressing Māori cervical cancer inequities and facilitating Māori wellness. The findings are anticipated to be applicable to other Indigenous and rural people in high-income countries.Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621000553875; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12621000553875.DERR1-10.2196/51643.©Beverley Lawton, Evelyn Jane MacDonald, Francesca Storey, Jo-Ann Stanton, Anna Adcock, Melanie Gibson, Varsha Parag, Ngaire Kereru Sparkes, Bobby Kaimoana, Frances King, Marion Terry, Huti Watson, Matthew Bennett, Charles Seymour Lambert, Stacie Geller, Isitokia Paasi, Merilyn Hibma, Peter Sykes, David Hawkes, Marion Saville. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 14.09.2023.