医学期刊编辑对生物医学研究伦理问题的处理方式调研及建议

【目的】 探讨医学期刊编辑处理生物医学研究伦理问题的方式,为推动确立医学期刊伦理审查规范提供参考。【方法】 通过问卷星向国内医学期刊编辑发放调查问卷,对审稿时和论文出版后处理医学伦理相关问题的方式展开调研。【结果】 共回收问卷230份。调查显示:在审稿阶段,在保护患者隐私方面,英文期刊、中英双语期刊的编辑更注重要求作者提供授权同意相关证明材料;中、英文期刊以及中英双语期刊的编辑对涉及人体试验伦理问题的处理方式都比较规范。但是,对于研究是否获得患者知情同意、动物实验研究是否经过伦理委员会审查、回顾性研究是否需要伦理审查、涉及人的研究是否在临床试验注册中心注册等问题,编辑还需要进一步重视。在论文出版后,编辑发现的医学伦理问题主要是“涉及人的研究未说明是否经过伦理委员会审查”。对论文出版后发现的没有保护患者隐私和没有在临床试验注册中心注册的问题,大部分期刊缺乏相关处理方案。【结论】 编辑应加强对论文知情同意、动物实验伦理、回顾性研究伦理的审查,并审查涉及人的研究是否在临床试验注册中心注册,以推动我国医学期刊的高质量发展。     

Public Preferences for Policies to Promote COVID-19 Vaccination Uptake: A Discrete Choice Experiment in The Netherlands

ObjectivesThe COVID-19 pandemic forms an unprecedented public health, economic, and social crisis. Uptake of vaccination is critical for controlling the pandemic. Nevertheless, vaccination hesitancy is considerable, requiring policies to promote uptake. We investigate Dutch citizens’ preferences for policies that aim to promote vaccination through facilitating choice of vaccination, profiling it as the norm, making vaccination more attractive through rewards, or punishing people who reject vaccination.MethodsWe conducted a discrete choice experiment in which 747 respondents were asked to choose between policies to promote vaccination uptake and their impacts on the number of deaths, people with permanent health problems, households with income loss, and a tax increase.ResultsRespondents generally had a negative preference for policies that promote vaccination. They particularly disliked policies that punish those who reject the vaccine and were more favorable toward policies that reward vaccination, such as awarding additional rights to vaccinated individuals through vaccination passports. Respondents who reject vaccination were in general much more negative about the policy options than respondents who consider accepting the vaccine. Nevertheless, vaccination passports are supported by both respondents who accept the vaccine, those who reject vaccination, and those who are unsure about vaccination.ConclusionsThis study provides concrete directions for governments attempting to increase the vaccination uptake in ways that are supported by the public. Our results could encourage policy makers to focus on policy options that make vaccination easier and reward people who take the vaccine, as especially the implementation of vaccination passports was supported.     

基于正交试验的肾造瘘管固定方案研究

目的 探讨基于正交试验的肾造瘘管不同固定方案的比较效果。方法 将14Fr硅胶肾造瘘管固定在聚乙烯展板和拉力显示器上，以固定材料、固定方法、面积为3个影响因素，每个因素3个水平，每组进行3次试验再求平均值作为最后拉力值F，共进行9个固定方案共27次试验。利用L9（33）正交试验矩阵研究不同材料（医用橡皮膏、医用透气胶带、医用无纺布胶带）、固定方法（交叉固定法、“工”字固定法和改良“工”字固定法）及面积(16 cm2、24 cm2、32 cm2）对肾造瘘管固定强度的影响。结果 正交试验所选的3种影响因素中，对拉力值影响显著性排序为：材料＞方法＞面积；3种固定材料中，医用橡皮膏固定强度最大。结论 肾造瘘管固定方案中，最佳固定组合为以医用橡皮膏结合改良“工”字法固定，可为临床管道固定方案的选择提供参考。     

A Discrete Choice Experiment to Elicit General Population Preferences Around the Factors Influencing the Choice to Make Clinical Negligence Claims

ObjectivesThis article determines public stated preferences around different factors that influence the choice to make clinical negligence claims against a national healthcare system.MethodsA large online survey was conducted using a discrete choice experiment (DCE) with the UK general population (N = 1013). DCE tasks involved a single profile and participants chose whether to make a claim for compensation (yes/no) after one of 3 randomly allocated patient safety incident (PSI) “scenarios” of different severities (mild, moderate, severe). DCE attributes described the actions of the healthcare system after a PSI and characteristics of the clinical negligence claims process. The data were modeled separately for each scenario (mild, moderate, severe) using logistic regression. Marginal effects and the probability of making a claim in a baseline case were estimated.ResultsProbability of choosing to claim was reduced by receipt of an apology, investigation and prevention of recurrence of the PSI, and longer time until claim decision and increased by an easy and straightforward claims process and high chance of compensation and for the mild scenario higher compensation amounts. Marginal effects and baseline case probabilities differed by scenario severity.ConclusionsThe results suggest the actions of the healthcare system after a PSI and characteristics of the claims process have a larger impact on the probability of making a claim for milder PSIs. For more severe PSIs, a larger probability of making a claim was observed, and the choice was less influenced by the actions of the healthcare system after the PSI and characteristics of the claims process.     

Low percentage of patients passed the ‘Back in Action’ test battery 9 months after bone-patellar tendon-bone anterior cruciate ligament reconstruction

BackgroundAnterior cruciate ligament (ACL) reconstruction is recommended in patients who intend to return to high-level sports. However, there is only a 55–80% return to pre-injury level of sports after ACL reconstruction, with a re-injury rate up to 20%. The aim of this study was to determine the percentage of patients passing the Back in Action (BIA) test 9 months after primary bone-patellar-tendon-bone (BPTB) ACL reconstruction, and evaluate the association between passing the BIA test and patient reported outcome measurements (PROMs).MethodsPatients underwent the BIA test 9 months after BPTB ACL reconstruction. In total 103 patients were included. Passing the BIA test (PASSED-group) was defined as a normal or higher score at all sub-tests with limb symmetry index (LSI) ≥90% for the dominant leg and LSI >80% for the non-dominant leg. Patients who did not meet these criteria were defined as the FAILED-group. PROMs included the International Knee Documentation Committee, Knee injury Osteoarthritis Outcome Score and Anterior Cruciate Ligament-Return to Sport after Injury.ResultsEighteen patients (17.5%) passed the BIA test 9 months after BPTB ACL reconstruction. PROMs were not statistically significant different between the PASSED- and FAILED-group.ConclusionLow percentage of patients passed the BIA test 9 months after BPTB ACL reconstruction. Although current PROMs cut-off values were met, the BIA test results show persistent functional deficits. Therefore, the BIA test could be of additional value in the decision-making process regarding return to sport (RTS). This study highlights the need for additional rehabilitation as RTS in a condition of incomplete recovery may increase the risk of re-injury.Level of evidenceII.     

Accounting for Unobservable Preference Heterogeneity and Evaluating Alternative Anchoring Approaches to Estimate Country-Specific EQ-5D-Y Value Sets: A Case Study Using Spanish Preference Data

ObjectivesThe EuroQol Group published the EQ-5D-Y valuation protocol that recommends 2 valuation techniques to elicit preferences: composite time trade-off (C-TTO) and discrete choice experiments (DCEs). The protocol left the decision of what modeling approach to use open for researchers. Our aims were to explore modeling strategies allowing generation of EQ-5D-Y value sets and to produce an EQ-5D-Y Spanish value set.MethodsWe used EQ-5D-Y DCE and C-TTO data collected in Spain following the protocol and adopted a staged approach for our modeling exercise. First, we selected the best performing DCE latent class model and evaluated models from 2 to 10 classes. We selected the preferred model based on best goodness of fit in terms of the Bayesian information criterion. We considered 2 anchoring approaches to estimate utility values: (1) pits state anchoring and (2) hybrid models (using all available C-TTO responses). All analysis were weighted to be representative of the Spanish population.ResultsWe collected 1005 DCE and 200 C-TTO interviews. We selected a DCE model including 4 classes. Hybrid models using all available C-TTO observations produced a narrower range of values than the pits state anchoring approach.ConclusionsIn this article, we have presented an EQ-5D-Y value set that can be used for cost-utility analysis in Spain. The international EQ-5D-Y valuation protocol should be updated to include a different set of health states for the C-TTO experiment if researchers wish to use alternative anchoring approaches to the “pits state.”