NHS

NHS
  • 文章类型: Journal Article
    目的:目前对精神分裂症反复发作及相关疾病患者的推荐治疗是抗精神病药物治疗。然而,许多抗精神病药物使用者仍然功能受损,并经历严重的身体和精神副作用。本研究旨在评估逐步减少和停用抗精神病药物的成本效益,与24个月的心理健康服务维持治疗相比,健康和社会护理,和社会观点。
    方法:19项精神健康信托基金招募患者参加RADAR随机对照试验。根据患者报告的EQ-5D-5L计算质量调整生命年(QALYs),根据患者报告的ICACAP-A计算出的全部能力年数(YFC)。从医疗记录中收集精神卫生服务的使用和药物。其他资源使用和生产率损失是使用自填问卷收集的。成本是从公布的来源计算出来的。
    结果:253名参与者被随机分配:126名被分配到抗精神病药物剂量减少和127名被分配到维持。从任何角度来看,武器之间的总成本没有显着差异。QALYs没有显着差异(-0.035;95%CI:-0.123至0.052),而与维持组相比,减少组的YFCs显著较低(基线校正差值:-0.103;95%CI:-0.192~-0.014).减少策略以维护所有分析为主,不太可能具有成本效益。
    结论:对于长期服用抗精神病药物的精神分裂症和其他复发性精神病患者,与维持两年相比,逐步减少和停用抗精神病药物的策略不太可能具有成本效益。
    OBJECTIVE: The current recommended treatment for patients with recurrent episodes of schizophrenia and related conditions is antipsychotic medication. However, many antipsychotic users remain functionally impaired and experience serious physical and mental side effects. This study aims to assess the cost-effectiveness of a gradual antipsychotic reduction and discontinuation strategy compared to maintenance treatment over 24 months from a mental health services, health and social care, and societal perspectives.
    METHODS: Nineteen mental health trusts recruited patients to the RADAR randomised controlled trial. Quality adjusted life years (QALYs) were calculated from patient-reported EQ-5D-5L, with years of full capability (YFCs) calculated from the patient-reported ICECAP-A. Mental health services use and medication was collected from medical records. Other resource use and productivity loss was collected using self-completed questionnaires. Costs were calculated from published sources.
    RESULTS: 253 participants were randomised: 126 assigned to antipsychotic dose reduction and 127 to maintenance. There were no significant differences between arms in total costs for any perspectives. There were no significant difference in QALYs (-0.035; 95% CI: -0.123 to 0.052), whereas YFCs were significantly lower in the reduction arm compared to the maintenance arm (baseline-adjusted difference: -0.103; 95% CI: -0.192 to -0.014). The reduction strategy was dominated by maintenance for all analyses and was not likely to be cost-effective.
    CONCLUSIONS: It is unlikely that gradual antipsychotic reduction and discontinuation strategy is cost-effective compared with maintenance over two-years for patients with schizophrenia and other recurrent psychotic disorders who are on long-term antipsychotics.
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  • 文章类型: Journal Article
    目的:结节性痒疹(PN)是一种皮肤疾病,其特征是皮肤结节严重发痒,与重要的医疗保健资源利用(HCRU)有关。这项研究旨在评估英格兰PN总体和中度至重度PN(MSPN)患者的HCRU。
    方法:这项回顾性队列研究使用了来自英国临床实践研究数据链和医院事件统计的数据。在主要分析中,将轻度PN(MiPN)患者与MSPN患者的年龄和性别进行匹配。患者在2007年4月1日至2019年3月1日期间纳入研究。计算了全因HCCU,包括初级和二级保健接触者和费用(成本年2022)。
    结果:在23,522名确定的患者中,8,933符合纳入标准,与2,479名PN患者的主要匹配队列。随访期间,MSPN组和MiPN组的匹配队列初级护理访视次数分别为21.27/患者年(PPY)和11.35PPY.MSPN和MiPN组的任何门诊量为10.72PPY和4.87PPY,分别。MSPN和MiPN组的门诊皮肤科访视为1.96PPY和1.14PPY,分别。
    结论:PN,尤其是MSPN,在英国有很高的HCCU负担,强调需要新的和改进的疾病管理治疗。
    Purpose: Prurigo nodularis (PN) is a skin disease characterized by intensely itchy skin nodules and is associated with a significant healthcare resource utilization (HCRU). This study aimed to estimate the HCRU of patients in England with PN overall and moderate-to-severe PN (MSPN) in particular.
    Methods: This retrospective cohort study used data from the Clinical Practice Research Datalink and Hospital Episode Statistics in England. Patients with Mild PN (MiPN) were matched to patients with MSPN by age and gender for the primary analysis. Patients were enrolled in the study between 1st April 2007 and 1st March 2019. All-cause HCRU was calculated, including primary and secondary care contacts and costs (cost-year 2022).
    Results: Of 23,522 identified patients, 8,933 met the inclusion criteria, with a primary matched cohort of 2,479 PN patients. During follow up, the matched cohort\'s primary care visits were 21.27 per patient year (PPY) for MSPN group and 11.35 PPY for MiPN group. Any outpatient visits were 10.72 PPY and 4.87 PPY in MSPN and MiPN groups, respectively. Outpatient dermatology visits were 1.96 PPY and 1.14 PPY in MSPN and MiPN groups, respectively.
    Conclusion: PN, especially MSPN, has a high HCRU burden in England, highlighting the need for new and improved disease management treatments.
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  • 文章类型: Journal Article
    背景:在没有增加资金或人员配备的情况下,大多数精神卫生保健提供者面临着对心理治疗需求增加的挑战。为了克服这种供需不平衡,护理提供者必须提高服务提供的效率。
    目的:在本研究中,我们研究了支持人工智能(AI)的数字解决方案是否可以帮助精神卫生保健从业者更有效地利用他们的时间,从而减轻服务压力,改善患者预后。
    方法:在本研究中,我们专注于使用AI解决方案(LimbicAccess)来支持英国国家卫生服务机构的初始患者转诊和临床评估.数据来自英格兰的9家谈话疗法服务机构,包括64,862名患者。
    结果:我们表明,使用此AI解决方案可以通过减少临床医生在心理健康评估上花费的时间来提高临床效率。此外,我们在几个关键指标中发现使用AI解决方案的患者的预后有所改善,例如减少等待时间,降低辍学率,改善对适当治疗途径的分配,and,最重要的是,提高回收率。在调查AI解决方案实现这些改进的机制时,我们发现,在临床评估之前提供临床相关信息对于这些观察到的效应至关重要.
    结论:我们的结果强调了使用AI解决方案来支持精神卫生劳动力的效用,进一步强调AI解决方案在提高医疗服务效率和改善患者临床结局方面的潜力.
    BACKGROUND: Most mental health care providers face the challenge of increased demand for psychotherapy in the absence of increased funding or staffing. To overcome this supply-demand imbalance, care providers must increase the efficiency of service delivery.
    OBJECTIVE: In this study, we examined whether artificial intelligence (AI)-enabled digital solutions can help mental health care practitioners to use their time more efficiently, and thus reduce strain on services and improve patient outcomes.
    METHODS: In this study, we focused on the use of an AI solution (Limbic Access) to support initial patient referral and clinical assessment within the UK\'s National Health Service. Data were collected from 9 Talking Therapies services across England, comprising 64,862 patients.
    RESULTS: We showed that the use of this AI solution improves clinical efficiency by reducing the time clinicians spend on mental health assessments. Furthermore, we found improved outcomes for patients using the AI solution in several key metrics, such as reduced wait times, reduced dropout rates, improved allocation to appropriate treatment pathways, and, most importantly, improved recovery rates. When investigating the mechanism by which the AI solution achieved these improvements, we found that the provision of clinically relevant information ahead of clinical assessment was critical for these observed effects.
    CONCLUSIONS: Our results emphasize the utility of using AI solutions to support the mental health workforce, further highlighting the potential of AI solutions to increase the efficiency of care delivery and improve clinical outcomes for patients.
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  • 文章类型: Journal Article
    目的:调查英国医学院学生职业意向的差异。
    方法:横截面,混合方法在线调查。
    方法:主要研究包括所有44所英国医学院,这项分析包括42所医学院。
    方法:一万四百八十六名英国医学生。
    方法:医学生的职业意向,关注医学院之间的差异。次要结果包括医学生对NHS未来职业满意度的差异,医学院。
    结果:2.89%的学生打算完全离开医学,剑桥医学院的受访者比例最高。32.35%的受访者计划移民实习,阿尔斯特医学院的学生是最有可能的。在那些打算移民的人中,中央兰开夏大学表示无意返回的比例最高。加的夫医学院在完成FY2后打算担任非培训临床职位的学生比例最高。35.23%的参与医学生打算在毕业后2年内离开NHS,布莱顿和苏塞克斯在这些受访者中所占比例最高。只有17.26%的人对在NHS工作的前景感到满意,在全国范围内差异很大;Barts和伦敦医科学生的不满率最高。
    结论:这项研究揭示了英国医学院学生职业情绪的差异,强调需要注意影响这些趋势的因素。有相当比例的学生打算在毕业后的2年内退出NHS,机构之间有很大的差异。学生的意图可能受到各种因素的影响,包括课程重点和招聘实践。必须在医学院内重新评估这些方面,同时考虑到更广泛的国情,提高学生对NHS职业的看法。未来的研究应针对这些差异的根本原因,以促进职业满意度和保留率的提高。
    OBJECTIVE: To investigate differences in students\' career intentions between UK medical schools.
    METHODS: Cross-sectional, mixed-methods online survey.
    METHODS: The primary study included all 44 UK medical schools, with this analysis comprising 42 medical schools.
    METHODS: Ten thousand four hundred eighty-six UK medical students.
    METHODS: Career intentions of medical students, focusing on differences between medical schools. Secondary outcomes included variation in medical students\' satisfaction with a prospective career in the NHS, by medical school.
    RESULTS: 2.89% of students intended to leave medicine altogether, with Cambridge Medical School having the highest proportion of such respondents. 32.35% of respondents planned to emigrate for practice, with Ulster medical students being the most likely. Of those intending to emigrate, the University of Central Lancashire saw the highest proportion stating no intentions to return. Cardiff Medical School had the greatest percentage of students intending to assume non-training clinical posts after completing FY2. 35.23% of participating medical students intended to leave the NHS within 2 years of graduating, with Brighton and Sussex holding the highest proportion of these respondents. Only 17.26% were satisfied with the prospect of working in the NHS, with considerable variation nationally; Barts and the London medical students had the highest rates of dissatisfaction.
    CONCLUSIONS: This study reveals variability in students\' career sentiment across UK medical schools, emphasising the need for attention to factors influencing these trends. A concerning proportion of students intend to exit the NHS within 2 years of graduating, with substantial variation between institutions. Students\' intentions may be shaped by various factors, including curriculum focus and recruitment practices. It is imperative to re-evaluate these aspects within medical schools, whilst considering the wider national context, to improve student perceptions towards an NHS career. Future research should target underlying causes for these disparities to facilitate improvements to career satisfaction and retention.
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  • 文章类型: Journal Article
    总医学委员会的数据显示,在英国注册执业的女医生人数继续以比男医生人数更快的速度增长。我们的研究批判性地讨论了这种基于性别的转变的影响,考虑到医疗培训模式仍然不适合支持劳动力内部的公平和包容性,尽管有这种性别转变,但对女性的影响尤为明显。利用我们研究项目的数据绘制欠医生区域:医疗培训途径对NHS劳动力分布和健康不平等的影响,本文探讨了在NHS工作的医生的经验,考虑到围绕劳动力和其他方面的政策如何影响人们继续他们选择的职业道路的意愿和能力。有明确的证据表明,女性在一些专业如手术中的代表性不足,在不同的职业阶段,包括高级领导角色,我们的研究重点是有助于加强这些不足表现的结构因素。众所周知,医学教育和培训是医生生活中的形成点,对NHS服务提供有长期影响。通过详细了解这些途径如何无意中塑造了医生的生活和工作地点,我们将能够考虑如何最好地改变现有系统,为患者提供及时和适当的医疗服务。我们采取跨学科的理论方法,带来历史,对医疗保健问题的时空和社会学见解。这里,我们借鉴了在NHS工作的执业医生的前50次采访,这些医生在努力招募和留住医生的领域,探索职业传记的性别性质。我们还关注医生如何开辟自己的职业道路,或者尽管,个人和职业中断。
    Data from the General Medical Council show that the number of female doctors registered to practise in the UK continues to grow at a faster rate than the number of male doctors. Our research critically discusses the impact of this gender-based shift, considering how models of medical training are still ill-suited to supporting equity and inclusivity within the workforce, with particular impacts for women despite this gender shift. Drawing on data from our research project Mapping underdoctored areas: the impact of medical training pathways on NHS workforce distribution and health inequalities, this paper explores the experiences of doctors working in the NHS, considering how policies around workforce and beyond have impacted people\'s willingness and ability to continue in their chosen career path. There is clear evidence that women are underrepresented in some specialties such as surgery, and at different career stages including in senior leadership roles, and our research focuses on the structural factors that contribute to reinforcing these under-representations. Medical education and training are known to be formative points in doctors\' lives, with long-lasting impacts for NHS service provision. By understanding in detail how these pathways inadvertently shape where doctors live and work, we will be able to consider how best to change existing systems to provide patients with timely and appropriate access to healthcare. We take a cross-disciplinary theoretical approach, bringing historical, spatiotemporal and sociological insights to healthcare problems. Here, we draw on our first 50 interviews with practising doctors employed in the NHS in areas that struggle to recruit and retain doctors, and explore the gendered nature of career biographies. We also pay attention to the ways in which doctors carve their own career pathways out of, or despite of, personal and professional disruptions.
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  • 文章类型: Journal Article
    医疗保健专业人员可能会遇到与普通人群不同的医疗保健障碍。我们使用与医疗保健专业人员(n=44)的定性故事完成方法,探索了医疗保健专业人员对经历一段时间压力后胸痛的预期反应。使用反身性专题分析对数据进行了分析,其中确定了三个主题:“我哭还是继续?”:“沉默中的痛苦文化”确定了担心表达健康问题会被视为软弱,对职业机会有潜在影响。参与者还描述了自我诊断和自我药物治疗,而不是寻求帮助。\'\“我?有恐慌发作吗?”:心身羞耻\'建议心理健康问题可能会由于耻辱而被忽略。\'\“我们绝对不照顾自己\”:将多重责任的压力优先于自我护理\'确定了真实或感知的压力,以降低他们的健康。未来的研究应该探索保密设计,为解决文化规范和自我护理障碍的医疗保健专业人员提供及时有效的支持。
    Healthcare professionals may experience barriers to seeking healthcare that differ from the general population. We explored healthcare professionals\' anticipated responses to experiencing chest pain following a period of stress using qualitative story completion method with healthcare professionals (n = 44). Data were analysed using reflexive thematic analysis, which identified three themes: \'\"Do I cry or just carry on?\": A Culture of Suffering in Silence\' identified worries that expressing health concerns would be perceived as weakness, with potential impact on career opportunities. Participants also described self-diagnosis and self-medication rather than help-seeking. \'\"Me? Have a panic attack?\": Psychosomatic Shame\' suggested mental health issues may be ignored due to stigma. \'\"We definitely don\'t take care of ourselves\": Prioritising Pressures of Multiple Responsibilities over Self-care\' identified real or perceived pressures to de-prioritise their health. Future research should explore the design of confidential, time efficient support for healthcare professionals that tackle cultural norms and barriers to self-care.
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  • 文章类型: Journal Article
    抗菌素耐药性(AMR)是一种沉默且迅速升级的流行病,对全球卫生安全构成重大挑战。大流行期间,这项研究是在英国NHS基金会信托基金中进行的,目的是探索呼吸道感染(RTIs)的抗生素处方趋势,包括肺炎,以及2019年和2020年的COVID-19大流行。这项研究,在世卫组织AWARE分类的指导下,试图了解大流行对抗生素处方和抗菌药物管理(AMS)的影响。研究方法包括对25岁及以上接受RTI的成年人的病历进行回顾性审查,包括肺炎,2019年和2020年。AWaRe分类的应用实现了抗生素使用的结构化描述。该研究评估了640例RTIs患者的抗生素使用情况。值得注意的是,它观察到阿莫西林/克拉维酸的使用略有增加,阿奇霉素处方大幅增加,突出处方趋势的变化。尽管有这些变化,一些抗生素显示出稳定的消耗率。这些发现强调了在AMR威胁期间了解抗生素使用模式的重要性。大流行期间“观察”类别抗生素的使用增加强调了采取强有力的AMS措施的紧迫性。研究证实,将AWaRe分类纳入处方决策对于患者安全和打击抗生素滥用至关重要。这项研究为全球健康危机期间抗生素处方的变化提供了重要的见解,加强对AMS持续保持警惕的必要性,以有效应对AMR挑战。
    Antimicrobial resistance (AMR) is a silent and rapidly escalating pandemic, presenting a critical challenge to global health security. During the pandemic, this study was undertaken at a NHS Foundation Trust in the United Kingdom to explore antibiotic prescribing trends for respiratory tract infections (RTIs), including pneumonia, and the COVID-19 pandemic across the years 2019 and 2020. This study, guided by the WHO\'s AWaRe classification, sought to understand the impact of the pandemic on antibiotic prescribing and antimicrobial stewardship (AMS). The research methodology involved a retrospective review of medical records from adults aged 25 and older admitted with RTIs, including pneumonia, in 2019 and 2020. The application of the AWaRe classification enabled a structured description of antibiotic use. The study evaluated antibiotic use in 640 patients with RTIs. Notably, it observed a slight increase in the use of amoxicillin/clavulanic acid and a substantial rise in azithromycin prescriptions, highlighting shifts in prescribing trends. Despite these changes, some antibiotics displayed steady consumption rates. These findings highlight the importance of understanding antibiotic use patterns during the AMR threat. The increase in the usage of \"Watch\" category antibiotics during the pandemic emphasises the urgency of robust AMS measures. The research confirms that incorporating the AWaRe classification in prescribing decisions is crucial for patient safety and combating antibiotic misuse. This study provides essential insights into the changing landscape of antibiotic prescribing during a global health crisis, reinforcing the necessity for ongoing AMS vigilance to effectively address AMR challenges.
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  • 文章类型: Journal Article
    背景:该研究是对2022日历年由Heatherwood和WexhamPark医院的整形外科服务管理的患者进行的一项分析,包括在国际和英国进行的整容手术后的并发症。
    方法:患者通过当地数据库进行鉴定,并通过对患者电子病历的回顾性研究证实了患者的遭遇和管理。
    结果:在2022年期间,有23例患者接受了整容手术后并发症的管理。91%(n=21)的并发症与乳房整容手术和/或腹部成形术有关。78%(n=18)的患者在手术后的前两个月内出现。最常见的并发症是伤口裂开43%(n=10),术后感染39%(n=9)和血清瘤30%(n=7)。患者选择进行手术的最常见国家是土耳其,接受治疗的患者占48%(n=11)。52%(n=12)的病例得到了保守治疗,48%(n=11)的病例需要包括手术在内的侵入性手术。87%(n=20)的患者完成治疗后出院。
    结论:整容手术和旅游业是一种需求旺盛的现象,并且在这里会持续下去。英国严格的监管和法律程序可能不适用于国外,不利于患者护理。需要做出更大的努力来提高公众对寻求国际选择所涉及的风险以及如何自我筛选合适的诊所的认识。目前正在进行的国家审计可能需要扩大,以了解在处理这些外科探险的后果时对NHS部门的真正影响。
    The study was an analysis of patients managed by plastic surgery services at Heatherwood and Wexham Park hospitals during the calendar year 2022 for complications following cosmetic surgeries performed both internationally and within the United Kingdom.
    Patients were identified via local databases and encounters and management confirmed with retrospective studies of patient electronic medical records.
    23 patients were managed during the year 2022 for complications post cosmetic surgery. 91% (n = 21) of complications were related to breast cosmetic surgery and/or abdominoplasties. 78% (n = 18) of patients presented within the first two months following their procedure. The most common complications identified were wound dehiscence 43% (n = 10), post-operative infection 39% (n = 9) and seromas 30% (n = 7). The most common country selected for surgery by patients was Turkey with 48% (n = 11) of managed patients. 52% (n = 12) of cases were managed conservatively and 48% (n = 11) of cases required invasive procedures including surgery. 87% (n = 20) of patients were discharged with completed treatment.
    Cosmetic surgery and tourism are an in-demand phenomenon and appear here to stay. The stringent regulatory and legal processes in place in the UK may not be applicable abroad to the detriment of patient care. Greater effort is needed to increase public awareness to the risks involved in seeking international options and how to self-screen suitable clinics. Ongoing current national auditing may need to be expanded to understand the true impact on NHS units in dealing with the aftermath of these surgical expeditions.
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  • 文章类型: Journal Article
    背景:在英国的医生中,关于推迟专业培训的情绪越来越高,移民到国外行医,或者完全离开这个行业。这一趋势可能对英国职业的未来产生重大影响。这种情绪在医学生群体中的存在程度尚不清楚。
    目的:我们的主要结果是确定当前医学生毕业后和完成基础课程后的职业意向,并确定这些意向背后的动机。次要结果包括确定哪些,如果有的话,人口因素改变了医学毕业生追求不同职业道路的倾向,确定医学生计划追求哪些专业,并了解目前对在国家卫生局(NHS)工作的前景的看法。
    方法:确定医学生的职业意向(AIMS)研究是一项全国性的,多机构,和横断面研究,英国所有医学院的所有医学生都有资格参加。它是通过一本小说管理的,混合方法,和基于网络的问卷,并通过为此目的招募的大约200名学生的合作网络进行传播。将进行定量分析和主题分析。
    结果:该研究于2023年1月16日在全国范围内启动。数据收集于2023年3月27日关闭,数据分析已经开始。预计结果将在今年晚些时候公布。
    结论:NHS中的医生职业满意度是一个经过充分研究的话题;但是,缺乏能够为医学生提供对未来职业前景的洞察力的高能研究。预计这项研究的结果将使这个问题变得清晰。确定的医疗培训或NHS内部的改进领域可以有针对性地改善医生的工作条件,并帮助留住医学毕业生。结果也可能有助于未来的劳动力规划工作。
    DERR1-10.2196/45992。
    BACKGROUND: Among doctors in the United Kingdom, there is growing sentiment regarding delaying specialist training, emigrating to practice medicine abroad, or leaving the profession altogether. This trend may have substantial implications for the future of the profession in the United Kingdom. The extent to which this sentiment is also present in the medical student population is not well understood.
    OBJECTIVE: Our primary outcome is to determine current medical students\' career intentions after graduation and upon completing the foundation program and to establish the motivations behind these intentions. Secondary outcomes include determining which, if any, demographic factors alter the propensity to pursue different career paths available to a medical graduate, determining which specialties medical students plan on pursuing, and understanding current views on the prospect of working in the National Health Service (NHS).
    METHODS: The Ascertaining the Career Intentions of Medical Students (AIMS) study is a national, multi-institution, and cross-sectional study in which all medical students at all medical schools in the United Kingdom are eligible to participate. It was administered via a novel, mixed methods, and web-based questionnaire and disseminated through a collaborative network of approximately 200 students recruited for this purpose. Both quantitative and thematic analyses will be performed.
    RESULTS: The study was launched nationally on January 16, 2023. Data collection was closed on March 27, 2023, and data analysis has commenced. The results are expected to be available later in the year.
    CONCLUSIONS: Doctors\' career satisfaction within the NHS is a well-researched topic; however, there is a shortage of high-powered studies that are able to offer insight into medical students\' outlook on their future careers. It is anticipated that the results of this study will bring clarity to this issue. Identified areas of improvement in medical training or within the NHS could be targeted to improve doctors\' working conditions and help retain medical graduates. Results may also aid future workforce-planning efforts.
    UNASSIGNED: DERR1-10.2196/45992.
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  • 文章类型: Journal Article
    背景:修正案是在临床试验获得监管批准后对其进行的更改。修正案可能需要大量的时间和资源来制定,在参与站点进行审查和实施。这可能会影响临床试验的有效交付,并可能造成研究浪费。这项研究旨在确定最常见的修正案是什么,为什么他们被提交,什么,如果有的话,可以避免它们。
    方法:采用解释性序贯混合方法设计。第一条涉及对修正案样本的内容分析,在2009年9月至2020年3月期间由大学医院NHS信托赞助的试验中提交,以确定最常见的更改和修改原因。第二个环节涉及对审判利益相关方的半结构化访谈进行主题分析,以探讨他们对提交修正案的原因的看法,以及可能阻止可避免的修订的潜在效率。
    结果:从53项临床研究中检查了242项批准的修正案。“增加网站”是最常见的修正案更改,修改的最常见原因是“为了实现审判的招募目标”。11名受访者确定的可避免的修改的根本原因包括:\“在知道以后需要修改的情况下匆忙提出最初的申请\”,\'在审判开始时不涉及所有合适的人输入\',和“在交付试验时在实践中实现它是不可行的”。在繁重且容易出错的申请过程中,缺少监管检查也被认为是某些修订的原因。
    结论:试验需要各利益相关方进行严格审查,并有足够的时间进行规划和可行性评估,以避免一些修改。这可能会提高临床试验效率,为了使试验参与者受益,研究人员,资助者,赞助商,和监管机构,并有可能更快地为患者带来新的治疗方法。
    BACKGROUND: Amendments are changes made to a clinical trial after it has received regulatory approval. An amendment can take a significant amount of time and resources to develop, review and implement at participating sites. This can affect the efficient delivery of clinical trials and potentially contribute to research waste. This study aimed to establish what the most common amendments are, why they are submitted, and what, if anything, can be done to avoid them.
    METHODS: An explanatory sequential mixed methods design was employed. The first strand involved a content analysis on a sample of amendments, submitted in trials sponsored by a University Hospital NHS Trust between September 2009 and March 2020, to establish the most common changes and reasons for amendments. The second strand involved thematically analysing semi-structured interviews with trial stakeholders to explore their views on the reasons underpinning the submission of amendments, and the potential for efficiencies that could prevent avoidable amendments.
    RESULTS: Two hundred forty-two approved amendments were examined from 53 clinical research studies. The \'Addition of sites\' was the most common amendment change, and the most common reason for amendments was \'To achieve the trial\'s recruitment target\'. The root causes for avoidable amendments identified by the 11 interviewees included the following: \'Rushing the initial application knowing an amendment will be needed later\', \'Not involving all the right people to input\' at the start of the trial, and \'Realising it\'s not feasible in practice when delivering the trial\'. Missing regulatory checks following an onerous and error-prone application process were also identified as the cause of some amendments.
    CONCLUSIONS: Trials need to be critically reviewed by various stakeholders and have sufficient time allocated to planning and feasibility assessments to avoid some amendments. This may improve clinical trial efficiency, to benefit the trial participants, researchers, funders, sponsors, and regulatory bodies, and potentially bring new treatments to patients faster.
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