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"WE CAN ALL CONTRIBUTE IN OUR OWN WAY" : KNOWLEDGE MOBILIZATION TOOLS TO PROMOTE BEST PRACTICES IN UNIVERSAL ACCESSIBILITY "我们都能以自己的方式做出贡献":推广普及无障碍最佳做法的知识动员工具
Pub Date : 2024-09-18 DOI: 10.1101/2024.09.17.24313810
Maelle Corcuff, Marie-Eve Lamontagne, Francois Routhier
Background: Cities aim to enhance urban accessibility following the adoption of the United Nations' Convention on the Rights of Persons with Disabilities. However, implementation faces challenges due to complex municipal legislation, lack of awareness, and organizational obstacles. Engaging stakeholders and empowering municipal employees through knowledge mobilization is crucial, as shown in a Quebec City's partnership research process. Methods: The aim of this study is to report the implementation strategy as implemented, explore the perception of the employees about the format and feasibility of the implementation strategy and explore the induced changes of knowledge mobilization tools on the implementation determinants of universal accessibility measures for municipal employees. The study used a multi-method design, involving interviews and a questionnaire with the project steering committee, made up of city employees and the research team. Three 30-minute participatory workshops were conducted for culture, communications, and public consultation administrative units. Results: Participants appreciated the workshop format and video content, suggesting minor improvements for broader implementation. The tools effectively increased engagement in implementing universal accessibility measures, proving valuable for raising awareness. Discussion and Conclusion: The study demonstrates the advantages of a collaborative approach in developing knowledge mobilization tools, enhancing municipal personnel's capacity for universal accessibility measures, and highlighting the need for adaptable strategies.
背景:联合国通过《残疾人权利公约》后,各城市都致力于提高城市的无障碍环境。然而,由于复杂的市政立法、缺乏认识和组织障碍,实施工作面临挑战。正如魁北克市的合作研究过程所示,通过知识动员让利益相关者参与进来并增强市政员工的能力至关重要。方法:本研究的目的是报告已实施的实施策略,探索员工对实施策略的形式和可行性的看法,并探索知识动员工具对市政员工实施通用无障碍措施的决定因素所产生的诱导性变化。研究采用了多种方法设计,包括对由市政雇员和研究团队组成的项目指导委员会进行访谈和问卷调查。此外,还为文化、通信和公共咨询行政单位举办了三场 30 分钟的参与式研讨会。结果:与会者对研讨会的形式和视频内容表示赞赏,并建议在更广泛的实施过程中略作改进。这些工具有效地提高了参与实施通用无障碍措施的积极性,证明了其在提高认识方面的价值。讨论与结论:这项研究表明,在开发知识动员工具、提高市政人员实施无障碍通行措施的能力方面,合作方法具有优势,同时也突出了对适应性战略的需求。
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引用次数: 0
Geospatial Analysis of the Association between Medicaid Ex-pansion, Minimum Wage Policies, and Alzheimer's Disease Dementia Prevalence in the United States 对美国医疗补助扩展、最低工资政策和阿尔茨海默病痴呆症患病率之间关系的地理空间分析
Pub Date : 2024-09-11 DOI: 10.1101/2024.09.10.24313418
Abolfazl Mollalo, Sara Knox, Jessica Meng, Andreana Benitez, Leslie A. Lenert, Alexander V. Alekseyenko
Previous studies indicate that improved healthcare access through Medicaid expansion and alleviation of socioeconomic stressors via higher minimum wages improved health outcomes. This study investigates the spatial relationships between the Medicaid expansion, minimum wage policy, and AD dementia prevalence across the US. We employed the Getis-Ord Gi* statistic to identify hotspots and cold spots of AD dementia prevalence at the county level. We compared these locations with the overall social vulnerability index (SVI) scores and assessed the proportion of hot and cold spots at the state level based on Medicaid expansion and minimum wage status. Most vulnerable SVI quartile (Q4) had the highest number of hotspots (n=311, 64.8%), while the least vulnerable quartile (Q1) had the fewest hotspots (n=22, 4.6%) (Chis-squared=967;R2=307.41, P<0.01). States that adopted Medicaid expansion had a significantly lower proportion of hotspots compared to non-adopting states (P<0.05), and the non-adopting states had significantly higher odds of having hotspots than adopting states (OR=2.58, 95% CI: 2.04-3.26, P<0.001). Conversely, the non-adopting states had significantly lower odds of having cold spots compared to the adopting states (OR=0.24, 95% CI: 0.19-0.32, P<0.01). States with minimum wage levels at or below the federal level showed significantly higher odds of having hotspots than states with a minimum wage above the federal level (OR=1.94, 95% CI: 1.51-2.49, P<0.01). Our findings suggest significant disparities in AD dementia prevalence related to socioeconomic and policy factors and lay the groundwork for future causal analyses.
以往的研究表明,通过扩大医疗补助计划来改善医疗保健的可及性,以及通过提高最低工资来减轻社会经济压力,都能改善健康状况。本研究调查了美国各地医疗补助扩展、最低工资政策和注意力缺失性痴呆症发病率之间的空间关系。我们采用 Getis-Ord Gi* 统计法,在县一级识别出注意力缺失性痴呆症发病率的热点和冷点。我们将这些地点与总体社会脆弱性指数(SVI)得分进行了比较,并根据医疗补助计划的扩展和最低工资状况评估了州一级热点和冷点的比例。最脆弱的 SVI 四分位数(Q4)的热点数量最多(n=311,64.8%),而最不脆弱的四分位数(Q1)的热点数量最少(n=22,4.6%)(Chis-squared=967;R2=307.41, P<0.01)。与未采用医疗补助扩展方案的州相比,采用医疗补助扩展方案的州的热点比例明显较低(P<0.05),未采用医疗补助扩展方案的州出现热点的几率明显高于采用医疗补助扩展方案的州(OR=2.58,95% CI:2.04-3.26,P<0.001)。相反,未采用该指标的州与采用该指标的州相比,出现冷点的几率明显较低(OR=0.24,95% CI:0.19-0.32,P<0.01)。最低工资水平为联邦水平或低于联邦水平的州出现热点的几率明显高于最低工资水平高于联邦水平的州(OR=1.94,95% CI:1.51-2.49,P<0.01)。我们的研究结果表明,注意力缺失性痴呆症发病率的显著差异与社会经济和政策因素有关,并为未来的因果分析奠定了基础。
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引用次数: 0
The clinical and cost-effectiveness of interventions for preventing continence issues resulting from birth trauma: a rapid review 预防产伤导致的尿失禁问题的干预措施的临床和成本效益:快速审查
Pub Date : 2024-09-09 DOI: 10.1101/2024.09.09.24313310
Bethany Fern Anthony, Jacob Davies, Kalpa Pisavadia, Sofie Roberts, Llinos Haf Spencer, Elizabeth Gillen, Juliet Hounsome, Jane C Noyes, Dyfrig A Hughes, Deborah Fitzsimmons, Rhiannon Tudor Edwards, Adrian G Edwards, Alison Cooper, Ruth Lewis
Urinary and faecal incontinence, which are often linked to the stresses and strains of childbirth, particularly perineal trauma, are debilitating conditions that can significantly impact womens quality of life. Approximately 85% of vaginal births in the United Kingdom (UK) are affected by childbirth related perineal trauma, either spontaneously or due to episiotomy. Incontinence also places a significant financial burden on the healthcare system. Previous estimates have shown that stress urinary incontinence alone costs the National Health Service (NHS) 177 million UK pounds per year.The aim of this rapid review was to identify evidence on the clinical effectiveness and cost-effectiveness of interventions for preventing continence issues resulting from birth trauma. Twenty-three studies, published between 2023 and 2024, were included in this review: 20 systematic reviews of clinical effectiveness and three economic evaluations. A number of key findings, research implications and evidence gaps were identified.The findings support the use of exercise-based interventions including pelvic floor muscle training for prenatal and postnatal women to prevent urinary incontinence. However, there is limited evidence supporting their long-term effectiveness. Incontinence is a potential long-term burden as pregnancy and childbirth can weaken the pelvic floor, making women more susceptible to incontinence in later life. Menopause often exacerbates these issues due to hormonal changes and by further weakening the pelvic floor muscles. Non exercise-based interventions, such as prenatal perineal massage and vaginal devices were less represented in the available evidence base, especially for faecal incontinence outcomes. There was a paucity of economic evaluations assessing the cost-effectiveness of interventions for incontinence, however, the substantial economic burden of incontinence on the NHS necessitates investment in clinically effective, preventative options. Our findings present the case for investing in exercise-based interventions. Further research is needed to evaluate the maintenance and long-term effects of exercise-based therapy. More research is also needed that focus on alternative type interventions and the prevention of faecal incontinence. Future reviews need to consider qualitative findings of womens experiences and the acceptability and feasibility of rolling out interventions for the prevention of incontinence.
尿失禁和大便失禁通常与分娩时的压力和紧张有关,尤其是会阴部创伤,这种情况会使人衰弱,严重影响妇女的生活质量。在英国,大约 85% 的阴道分娩都会受到与分娩相关的会阴创伤的影响,这些创伤可能是自然造成的,也可能是外阴切开术造成的。尿失禁也给医疗系统带来了巨大的经济负担。根据之前的估算,仅压力性尿失禁一项每年就会给英国国民健康服务系统(NHS)造成 1.77 亿英镑的损失。本次快速审查旨在找出有关预防分娩创伤导致的尿失禁问题的干预措施的临床有效性和成本效益的证据。本综述纳入了 2023 年至 2024 年间发表的 23 项研究:其中包括 20 篇临床有效性系统综述和 3 篇经济评估。研究结果支持对产前和产后妇女进行运动干预,包括盆底肌肉训练,以预防尿失禁。然而,支持其长期有效性的证据有限。尿失禁是一种潜在的长期负担,因为怀孕和分娩会削弱骨盆底肌,使妇女在以后的生活中更容易出现尿失禁。由于荷尔蒙的变化以及骨盆底肌肉的进一步减弱,更年期往往会加剧这些问题。非运动型干预措施,如产前会阴按摩和阴道装置,在现有的证据库中较少出现,尤其是对大便失禁结果而言。对尿失禁干预措施的成本效益进行评估的经济评价很少,但是,尿失禁对国家医疗服务体系造成了巨大的经济负担,因此有必要对临床有效的预防性方案进行投资。我们的研究结果表明,有必要对以运动为基础的干预措施进行投资。还需要进一步的研究来评估运动疗法的维持效果和长期效果。还需要进行更多的研究,重点关注替代型干预措施和粪便失禁的预防。未来的审查需要考虑妇女经验的定性研究结果,以及推出预防尿失禁干预措施的可接受性和可行性。
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引用次数: 0
Supporting women, girls and people who menstruate to participate in physical activity - Rapid evidence summary 支持妇女、女孩和月经期妇女参加体育活动--快速证据摘要
Pub Date : 2024-09-09 DOI: 10.1101/2024.09.02.24311982
Judit Csontos, Deborah Edwards, Elizabeth Gillen, Juliet Hounsome, Meg Kiseleva, Mala Mann, Amrita Sidhu, Steven Macey, Ruth Lewis, Adrian Edwards, Alison Cooper
Insufficient physical activity is a leading risk factor for non-communicable diseases and has a negative effect on mental health and quality of life. Women, girls and people who menstruate living in Wales are less likely to engage in regular physical activity than boys and men. The aim of this rapid evidence summary is to identify research focusing on physical activity participation (including exercise and sport) of women, girls and people who menstruate in relation to the menstrual cycle, to inform the Welsh Government Period Proud Action Plan. Results42 reports were identified, including overviews of reviews, systematic reviews, a scoping review, organisational reports, and primary studies. The secondary research evidence was published between 2008 and 2024 with the most recent searches being conducted in September 2023. The primary studies were published between 2020 and 2022. The organisational reports were published between 2018 and 2024. Research Implications and Evidence GapsThere is a need for interventions that could support physical activity participation (including exercise or sport) of women, girls and people who menstruate in relation to the menstrual cycle. These interventions need to consider and address barriers that women, girls and people who menstruate face in relation to their menstrual cycle, and robust evaluations are required to determine effectiveness.
体育锻炼不足是非传染性疾病的主要风险因素,对心理健康和生活质量有负面影响。与男孩和男人相比,威尔士的妇女、女孩和月经期妇女不太可能经常参加体育锻炼。本快速证据摘要旨在确定有关妇女、女孩和月经期妇女参与与月经周期相关的体育活动(包括锻炼和运动)的研究,为威尔士政府的 "月经期骄傲行动计划 "提供信息。结果发现了 42 份报告,包括综述、系统性综述、范围界定综述、组织报告和初级研究。二次研究证据发表于 2008 年至 2024 年,最近一次搜索是在 2023 年 9 月进行的。主要研究发表于 2020 年至 2022 年。组织报告发表于 2018 年至 2024 年。研究意义和证据缺口需要采取干预措施,以支持妇女、女孩和月经期妇女参加与月经周期有关的体育活动(包括锻炼或运动)。这些干预措施需要考虑并解决妇女、女孩和月经患者在月经周期中面临的障碍,并需要进行有力的评估以确定其有效性。
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引用次数: 0
Performance of the Washington Group Questions in Measuring Blindness and Deafness 华盛顿组问题在测量盲人和聋人方面的表现
Pub Date : 2024-08-31 DOI: 10.1101/2024.08.27.24312660
Scott D. Landes, Bonnielin K. Swenor, Jean P. Hall
The Washington Group Short Set (WGSS) questions are intended to measure the severity of disability and disability status in US federal surveys. We used data from the 2010-2018 National Health Interview Survey to examine the performance of the WGSS visual disability and hearing disability questions in capturing blindness and deafness. We found that the WGSS questions failed to capture 35.7% of blind adults and 43.7% of deaf respondents as having a severe disability, or, per their recommended cut point, as being disabled at all. Coupled with prior evidence demonstrating the poor performance of the WGSS questions in estimating the size of the overall disability population, we contend that results from this study necessitate a pause in use of the WGSS questions to measure disability in US federal surveys.
在美国联邦调查中,华盛顿组简易问题集(WGSS)问题旨在测量残疾的严重程度和残疾状况。我们利用 2010-2018 年全国健康访谈调查的数据,研究了 WGSS 视力残疾和听力残疾问题在捕捉失明和失聪方面的表现。我们发现,WGSS 的问题未能将 35.7% 的成年盲人和 43.7% 的聋人受访者视为严重残疾,或根据其建议的切点,未能将其视为完全残疾。再加上之前有证据表明 WGSS 问题在估计整体残疾人口数量方面表现不佳,我们认为本研究的结果表明有必要暂停在美国联邦调查中使用 WGSS 问题来测量残疾情况。
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引用次数: 0
Application of chaos and systems theories to explore health workforce re-organisation following district splitting in Uganda 应用混沌和系统理论探讨乌干达地区分割后的医疗卫生队伍重组问题
Pub Date : 2024-08-30 DOI: 10.1101/2024.08.29.24312785
Aloysius Mutebi, Moses Mukuru, Suzanne Kiwanuka, Fredrick Makumbi, Elizeus Rutebemberwa
Background District splitting (DS) began in 1962 and intensified in 1997 during implementation of decentralization. This legislative process focuses on geographical demarcation. The health system, organized along local government structures, was re-organized as a result of DS. However, this study explored how the health workforce, as a component of the local government health system, re-organized following district splitting.
背景 地区划分(DS)始于 1962 年,1997 年在实施权力下放过程中得到加强。这一立法进程的重点是地理划分。卫生系统按照地方政府的结构进行了重组。然而,本研究探讨了作为地方政府卫生系统组成部分的卫生工作者队伍在地区分割后是如何重组的。
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引用次数: 0
Questionable practices in data and code sharing policy in high-profile medical journal and research 备受瞩目的医学期刊和研究在数据和代码共享政策方面的可疑做法
Pub Date : 2024-08-30 DOI: 10.1101/2024.08.29.24312818
Wei Li, Xuerong Liu, Qianyu Zhang, Liping Shi, Jing-Xuan Zhang, Xiaolin Zhang, Jia Luan, Yue Li, Ting Xu, Rong Zhang, Xiaodi Han, Jingyu Lei, Xueqian Wang, Yaozhi Wang, Hai Lan, Xiaohan Chen, Yi Wu, Yan Wu, Lei Xia, Haiping Liao, Chang Shen, Yang Yu, Xinyu Xu, Chao Deng, Pei Liu, Zhengzhi Feng, Chun-Ji Huang, Zhiyi Chen
Background The spurious and unavailable data/code sharing actions are crashing open medical sciences. In this study, we aimed to illustrate how high-profile medical journals are practically carried out their sharing policies and what questionable practices regarding data/code sharing are conducted by authors.
背景虚假和不可用的数据/代码共享行为正在摧毁开放的医学科学。在本研究中,我们旨在说明知名医学期刊是如何实际执行其共享政策的,以及作者在数据/代码共享方面有哪些可疑做法。
{"title":"Questionable practices in data and code sharing policy in high-profile medical journal and research","authors":"Wei Li, Xuerong Liu, Qianyu Zhang, Liping Shi, Jing-Xuan Zhang, Xiaolin Zhang, Jia Luan, Yue Li, Ting Xu, Rong Zhang, Xiaodi Han, Jingyu Lei, Xueqian Wang, Yaozhi Wang, Hai Lan, Xiaohan Chen, Yi Wu, Yan Wu, Lei Xia, Haiping Liao, Chang Shen, Yang Yu, Xinyu Xu, Chao Deng, Pei Liu, Zhengzhi Feng, Chun-Ji Huang, Zhiyi Chen","doi":"10.1101/2024.08.29.24312818","DOIUrl":"https://doi.org/10.1101/2024.08.29.24312818","url":null,"abstract":"<strong>Background</strong> The spurious and unavailable data/code sharing actions are crashing open medical sciences. In this study, we aimed to illustrate how high-profile medical journals are practically carried out their sharing policies and what questionable practices regarding data/code sharing are conducted by authors.","PeriodicalId":501386,"journal":{"name":"medRxiv - Health Policy","volume":"6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142188802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Overlap between ultra-processed food and food that is high in fat, salt or sugar: analysis of 11 annual waves of the UK National Diet and Nutrition Survey 2008/09-2018/19 超加工食品与高脂、高盐或高糖食品之间的重叠:对 2008/09-2018/19 年 11 次英国全国膳食与营养调查年度波次的分析
Pub Date : 2024-08-28 DOI: 10.1101/2024.08.27.24312650
Viktorija Kesaite, Yanaina Chavez-Ugalde, Martin White, Jean Adams
While many countries use guidance and policies based on nutrients and food groups to support citizens to consume healthy diets, fewer have explicitly adopted the concept of ultra-processed foods (UPF). UPF consumption is associated with many adverse health outcomes in cohort studies. In the UK, a nutrient profiling model (NPM) is used to identify foods high in fat, salt or sugar (HFSS) and several policies target these. It is not known how well the NPM also captures UPF. We aimed to quantify the proportion of food and drink items consumed in the UK that are HFSS, UPF, both or neither and describe the food groups making the largest contributions to each category. We analysed data from the National Diet and Nutrition Survey (NDNS), between 2008/09 and 2018/19, using descriptive statistics. We used three metrics of food consumption: all foods, % of energy in all foods (reflecting that different foods are consumed in different portion sizes and are of different energy densities), and % of food weight in all foods (reflecting that some UPFs have few calories but are consumed in large volumes). We found that, 33.4% of foods, 47.4% of energy, and 16.0% of food weight were HFSS; 36.2%, 59.8% and 32.9% respectively were UPFs; 20.1%, 35.1% and 12.6% were both; and 50.5%, 27.9% and 63.7% were neither. In total, 55.6% of UPF foods, 58.7% of energy from UPFs and 38.3% of food weight from UPF consumed were also HFSS. The most common food groups contributing to foods that were UPF but not HFSS were low calorie soft drinks and white bread. The UK NPM captures at best just over half of UPFs consumed in the UK. Expanding the NPM to include ingredients common in UPFs would capture a larger percentage of UPFs and could incentivise de-formulation of UPF products.
虽然许多国家采用基于营养素和食物类别的指导和政策来支持公民摄入健康饮食,但明确采用超加工食品(UPF)概念的国家较少。在队列研究中,超加工食品的消费与许多不良健康结果有关。在英国,营养素分析模型(NPM)被用来识别高脂、高盐或高糖食品(HFSS),有几项政策就是针对这些食品制定的。目前尚不清楚 NPM 对 UPF 的捕捉效果如何。我们的目标是量化英国人消费的食品和饮料中,高脂、高盐、高糖、两者皆有或两者皆无的比例,并描述对每类食品贡献最大的食品类别。我们使用描述性统计方法分析了 2008/09 年至 2018/19 年期间全国膳食和营养调查(NDNS)的数据。我们使用了三种食物消费指标:所有食物、所有食物中能量的百分比(反映出不同食物的食用份量不同,能量密度也不同),以及所有食物中食物重量的百分比(反映出一些 UPF 热量低,但食用量大)。我们发现,33.4%的食物、47.4%的能量和16.0%的食物重量属于高脂低糖食物;36.2%、59.8%和32.9%的食物属于高脂低糖食物;20.1%、35.1%和12.6%的食物既属于高脂低糖食物,也属于高脂低糖食物;50.5%、27.9%和63.7%的食物既不属于高脂低糖食物,也不属于高脂低糖食物。合 共 55.6% 的 UPF 食物、58.7% 的 UPF 能量和 38.3% 的 UPF 食物重量也是高饱和脂肪酸。低热量软饮料和白面包是最常见的低热量食品而非高热量低脂食品。英国国家预防机制最多只能捕捉到英国消费的一半以上的 UPF。扩大 "国家预防机制 "的范围,将 UPF 中常见的配料纳入其中,将能捕捉到更大比例的 UPF,并可鼓励取消 UPF 产品的配方。
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引用次数: 0
The Effects of Social Distancing Policy on the Changes of Floating Population in Korea 社会隔离政策对韩国流动人口变化的影响
Pub Date : 2024-08-28 DOI: 10.1101/2024.08.26.24312613
Jaehwan Oh, Minsu Choi, Kwang-soo Lee
Objectives In response to the World Health Organization’s declaration of the COVID-19 pandemic in March 2020, nations worldwide, including Korea, implemented social distancing as a critical Non-Pharmaceutical Intervention (NPI) to curb the spread of the disease. Social distancing measures aimed to reduce person-to-person contact through various strategies such as facility restrictions, gathering limitations, travel bans, and lockdowns.
目标 针对世界卫生组织于 2020 年 3 月宣布的 COVID-19 大流行,包括韩国在内的世界各国实施了社会隔离措施,作为遏制疾病传播的重要非药物干预措施(NPI)。社会隔离措施旨在通过各种战略,如设施限制、集会限制、旅行禁令和封锁,减少人与人之间的接触。
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引用次数: 0
A foggy minefield: Experiences of regulation among developers of AI and other medical software in the UK, survey and focus group study 迷雾重重的雷区:英国人工智能和其他医疗软件开发商的监管经验,调查与焦点小组研究
Pub Date : 2024-08-26 DOI: 10.1101/2024.08.25.24312551
Henry W W Potts, Paulina Bondaronek, Ana Luisa Neves, Alex Bolotov, Lucie Burgess, Jona Shehu, Gabriella Spinellli, Emanuela Volpi, Austen El-Osta
Introduction: Regulation is important for medical software, but advances in software, notably developments in artificial intelligence (AI), are developing quickly. There are concerns that regulatory processes are not keeping up and that there is a need for more pro-innovation approaches.Methods: We conducted a survey (n = 34) and four focus groups to discuss experiences of regulation among UK-based developers.Results: In the survey, 35% agreed/strongly agreed that they were confident in their knowledge of relevant regulation, while 50% agreed/strongly agreed that poor regulation was allowing bad products to come to market. The focus groups identified 10 themes around challenges with current processes: the process of obtaining regulatory approval is uncertain; lack of knowledge about regulatory approval; difficulties in obtaining reliable advice; complexity and slow pace of approvals; difficult to get NHS clinician involvement; process is costly and difficult to fund; implications for competition; international differences; incentives to develop lower classification products; and lack of harmonisation between NHS and MHRA. Respondents' suggestions for solutions to improve processes fell under four themes: financial and structural support; regulatory collaboration and commissioner involvement; process efficiency and adaptability; and education and guidance.Discussion: Developers are unhappy with the process of regulation for medical software in the UK, finding it confusing and expensive. They feel systems compare poorly to international comparators. Integration between the MHRA system and NHS commissioning is considered poor.
导言:监管对医疗软件非常重要,但软件的进步,尤其是人工智能(AI)的发展日新月异。有人担心监管程序跟不上,需要采取更有利于创新的方法:我们进行了一项调查(n = 34)和四个焦点小组,以讨论英国开发人员的监管经验:在调查中,35% 的人同意/非常同意他们对相关法规的了解很有信心,而 50%的人同意/非常同意监管不力导致不良产品流入市场。焦点小组围绕当前流程面临的挑战确定了 10 个主题:获得监管批准的流程不确定;缺乏监管批准方面的知识;难以获得可靠的建议;审批复杂且速度缓慢;难以获得 NHS 临床医生的参与;流程成本高且难以获得资金;对竞争的影响;国际差异;开发低分类产品的动机;以及 NHS 和 MHRA 之间缺乏协调。受访者提出的改善流程的解决方案分为四个主题:财政和结构支持;监管合作和专员参与;流程效率和适应性;教育和指导:开发人员对英国医疗软件的监管流程感到不满,认为监管流程混乱且成本高昂。他们认为,与国际相比,英国的监管系统很不完善。他们认为 MHRA 系统与 NHS 委托管理之间的整合不佳。
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引用次数: 0
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medRxiv - Health Policy
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