基于COSMIN指南对癌症患者支持性照护需求量表的系统评价

背景国内外用于评估癌症患者支持性照护需求的量表较多，但有关此类量表质量的标准化评价研究及不同量表间的横向比较研究较为缺乏，也少有研究者对此类量表的测量特性进行系统的整合与评价。目的评价中文版癌症患者支持性照护需求量表的测量学性能及研究的方法学质量。方法2021年4月检索中国知网、万方数据知识服务平台、维普中文科技期刊全文数据库、中国生物医学文献数据库、PubMed、EmBase、Web of Science、CINAHL Complete数据库，获取有关中文版癌症患者支持性照护需求量表测量学性能评价的研究，检索时限均为建库至2021年3月30日。由两位研究者独立筛选文献、提取资料后，采用健康测量工具遴选标准（COSMIN）系统综述指南，在对量表的测量特性及研究的方法学质量进行评价的基础上，综合评定中文版癌症患者支持性照护需求评估量表各测量特性的证据等级，并形成对于量表的最终推荐意见。采用描述分析法对评价结果进行汇总、分析。结果共纳入15项研究，涉及8个中文版癌症患者支持性照护需求评估量表〔癌症患者支持性照护需求简明问卷中文版（SCNS-SF34）、中文版支持性照护需求筛查工具（SCNS-ST9-C）、癌症患者综合需求评估量表（CNAT）、癌症需求简明问卷（CNQ-SF）、中文版癌症患者未满足需求量表（CaSUN-C）、癌症患者未满足需求简明量表（SF-SUNS）、晚期癌症患者需求评估问卷（ACNQ-41）、晚期癌症患者需求评估表简表（ACNQ-29）〕。就量表的测量特性质量而言，除ACNQ-29的内容效度为"未提及"外，其余7个量表的内容效度均为"不确定"；除CaSUN-C、SF-SUNS的结构效度为"充分"外，其余6个量表的结构效度均为"不确定"；SCNS-SF34、CNQ-SF、CaSUN-C、SF-SUNS的内部一致性为"充分"，ACNQ-41的内部一致性为"不充分"，其余3个量表的内部一致性为"不确定"；CNAT、CNQ-SF、ACNQ-29的假设检验为"未提及"，CaSUN-C、SF-SUNS、ACNQ-41的假设检验为"不确定"，SCNS-SF34、SCNS-ST9-C的假设检验为"充分"；除ACNQ-41的稳定性为"不充分"，SCNS-ST9-C、ACNQ-29的稳定性为"未提及"外，其余5个量表的稳定性均为"充分"；仅SCNS-SF34的跨文化效度为"充分"，其余7个量表的跨文化效度均为"未提及"。8个量表的推荐等级均为B级。结论SCNS-SF34的测量特性得到了最为全面的评价，其具有较好的信效度，且临床应用可行性高，可暂时被推荐使用，但上述结论仍有待更多高质量证据加以支撑。     

药物饲料添加剂吉他霉素耐药性风险评估

目的 为给兽药减量政策的制定、动物源性食品安全的维护提供理论依据。方法 利用每日允许摄入量（ADI）、估算每日摄入量（EDI）及慢性风险熵（CRQ），对中国居民通过摄入肉蛋乳等动物性食品暴露于吉他霉素的耐药性风险进行点评估。结果 随着年龄增长，中国居民的吉他霉素膳食暴露量逐渐降低。2～7岁人群吉他霉素的膳食暴露量最高，男女分别为2.17和2.29 μg/ ( kg·bw·d)；＞65岁人群膳食暴露量最低，男女分别为0.45和0.46 μg/ ( kg·bw·d)。2～7岁人群通过摄入乳制品的吉他霉素的膳食暴露量最大，男女分别为1.15和1.22 μg/ ( kg·bw·d)，8岁以上人群通过摄入肉类食品的吉他霉素的膳食暴露量最大。中国居民通过摄入肉蛋乳等动物性食品暴露于吉他霉素，各年龄段CRQ均小于1。其中2～7岁人群CRQ值最高，风险最大；65岁以上人群CRQ值最低，风险最小。结论 中国居民通过摄入动物性食品的吉他霉素耐药性风险较低，危害程度较小，但儿童通过摄入乳制品的吉他霉素耐药性风险较高，有必要制定乳制品中吉他霉素残留的限量标准。     

Preventing Adverse Drug Reactions After Hospital Discharge (PADR-AD): Protocol for a randomised-controlled trial in older people

BackgroundAdverse drug reactions (ADRs) and adverse drug events (ADEs) in older people contribute to a significant proportion of hospital admissions and are common following discharge. Effective interventions are therefore required to combat the growing burden of preventable ADRs. The Prediction of Hospitalisation due to Adverse Drug Reactions in Elderly Community Dwelling Patients (PADR-EC) score is a validated risk score developed to assess the risk of ADRs in people aged 65 years and older and has the potential to be utilised as part of an intervention to reduce ADRs.ObjectivesThis trial was designed to investigate the effectiveness of an intervention to reduce ADR incidence in older people and to obtain further information about ADRs and ADEs in the 12–24 months following hospital discharge.MethodsThe study is an open-label randomised-controlled trial to be conducted at the Royal Hobart Hospital, a 500-bed public hospital in Tasmania, Australia. Community-dwelling patients aged 65 years and older with an unplanned overnight admission to a general medical ward will be recruited. Following admission, the PADR-EC ADR score will be calculated by a research pharmacist, with the risk communicated to clinicians and discussed with participants. Following discharge, nominated general practitioners and community pharmacists will receive the risk score and related medication management advice to guide their ongoing care of the patient. Follow-up with participants will occur at 3 and 12 and 18 and 24 months to identify ADRs and ADEs. The primary outcome is moderate-severe ADRs at 12 months post-discharge, and will be analysed using the cumulative incidence proportion, survival analysis and Poisson regression.SummaryIt is hypothesised that the trial will reduce ADRs and ADEs in the intervention population. The study will also provide valuable data on post-discharge ADRs and ADEs up to 24 months post-discharge.     

Implementing Real-World RECIST-based Tumor Response Assessment in Patients With Metastatic Non-small Cell Lung Cancer

BackgroundTo accelerate drug approvals while maintaining scientific rigor in the evaluation of a therapeutic's efficacy and safety, the United States Food and Drug Administration now considers real-world data (RWD) to support New Drug Applications and expanded indications. Response Evaluation Criteria in Solid Tumors (RECIST) are the gold standard in clinical trials, but the derivation of RECIST-based treatment response from RWD is unproven. This study investigated the feasibility of implementing RECIST criteria in RWD by comparing lung cancer response assessments from RECIST-based measurement of lesions on archived radiologic films with results from medical oncologist and radiologist narratives recorded in electronic health records (EHR).Materials and MethodsResponse to index treatment via different assessment approaches was compared among 30 metastatic non-small cell lung cancer (mNSCLC) patients receiving systemic treatment (index) after progression on a platinum or anti-PD(L)-1-containing regimen. Specifically, responses based on assessments documented in the medical oncologists’ narratives were compared to a radiologist's assessments of archived images using RECIST v1.1 criteria. Each patient's best overall response was characterized as complete or partial (CR/PR), stable disease (SD), progressive disease (PD), or not evaluable (NE).ResultsSimilar distributions of best overall response and substantial concordance (77%) between medical oncologist-reported and radiologist re-assessed responses were observed. There were no instances of CR/PR to PD or PD to CR/PR discordance.ConclusionsResults suggest that accurate treatment responses, similar to RECIST, may be derived using RWD. Further validation and improvement of real-world response assessment are needed to develop a scalable real-world approach for response assessment.     

一体化管理的老年综合评估护理模式对前列腺癌患者心理因素和生活质量的影响

目的探讨对前列腺癌患者采用一体化管理老年综合评估(CGA)护理模式对其心理因素和生活质量的影响。方法选取2020年3月至2021年3月在南京市第一医院就诊,确诊为前列腺癌,且首次行腹腔镜下前列腺癌根治术的患者96例,随机分为对照组、观察1组、观察2组,各32例。对照组为住院后采用常规护理模式进行护理,观察1组为入院后行CGA干预组,观察2组为一体化管理的CGA干预组。三组患者分别在干预前、出院时,进行焦虑自评量表(SAS)、抑郁自评量表(SDS)测评;在干预前、术后30 d,进行生活质量核心量表QLQ-C30(V3.0)和前列腺癌特异性补充量表QLQ-PR25测评。结果出院时,观察2组SAS、SDS评分显著优于对照组及观察1组(P<0.05);术后30 d,观察2组生活质量QLQ-C30、QLQ-PR25评分显著优于对照组及观察1组(P<0.05)。结论一体化管理CGA护理模式可有效改善前列腺癌患者的心理状态,提高其术后生活质量。     

What do we know about written assessment of health professionals’ communication skills? A scoping review

ObjectiveThe aim of this scoping review was to investigate the published literature on written assessment of communication skills in health professionals’ education.MethodsPubmed, Embase, Cinahl and Psychnfo were screened for the period 1/1995–7/2020. Selection was conducted by four pairs of reviewers. Four reviewers extracted and analyzed the data regarding study, instrument, item, and psychometric characteristics.ResultsFrom 20,456 assessed abstracts, 74 articles were included which described 70 different instruments. Two thirds of the studies used written assessment to measure training effects, the others focused on the development/validation of the instrument. Instruments were usually developed by the authors, often with little mention of the test development criteria. The type of knowledge assessed was rarely specified. Most instruments included clinical vignettes. Instrument properties and psychometric characteristics were seldom reported.ConclusionThere are a number of written assessments available in the literature. However, the reporting of the development and psychometric properties of these instruments is often incomplete. Practice implications written assessment of communication skills is widely used in health professions education. Improvement in the reporting of instrument development, items and psychometrics may help communication skills teachers better identify when, how and for whom written assessment of communication should be used.     

Differences in Evidentiary Requirements Between European Medicines Agency and European Health Technology Assessment of Oncology Drugs—Can Alignment Be Enhanced?

ObjectivesNational health technology assessments (HTAs) across Europe show differences in evidentiary requirements from assessments by the European Medicines Agency (EMA), affecting time to patient access for drugs after marketing authorization. This article analyzes the differences between EMA and HTA bodies’ evidentiary requirements for oncology drugs and provides recommendations on potential further alignment to minimize and optimally manage the remaining differences.MethodsInterviews were performed with representatives and drug assessment experts from EMA and HTA bodies to identify evidentiary requirements for several subdomains and collect recommendations for potentially more efficiently addressing differences. A comparative analysis of acceptability of the evidence by EMA and the HTA bodies and for potential further alignment between both authorities was conducted.ResultsAcceptability of available evidence was higher for EMA than HTA bodies. HTA bodies and EMA were aligned on evidentiary requirements in most cases. The subdomains showing notable differences concerned the acceptance of limitation of the target population and extrapolation of target populations, progression-free survival and (other) surrogate endpoints as outcomes, cross-over designs, short trial duration, and clinical relevance of the effect size. Recommendations for reducing or optimally managing differences included joint early dialogues, joint relative effectiveness assessments, and the use of managed entry agreements.ConclusionsDifferences between assessments of EMA and HTA bodies were identified in important areas of evidentiary requirements. Increased alignment between EMA and HTA bodies is suggested and recommendations for realization are discussed.     

Second primary malignancies after ovarian cancer: A SEER-based analysis (1975–2016)

ObjectiveTo investigate the risk of occurrence of second primary malignancies (SPMs) in survivors of ovarian cancer (OC) using large data from the Surveillance, Epidemiology, and End Results (SEER) database.Materials and methodsMultiple primaries standardized incidence ratios (MP-SIRs) to calculate the risk of developing second primary malignancies after a diagnosis of ovarian cancer.ResultsOf our included 59,880 women with OC, 3972 cases (6.6%) developed 4495 s primary malignancies over an average follow-up period of 114.39 (±102.66) months. Overall, the risk of occurrence of second primary malignancies after a diagnosis of OC was greater than what would be expected for a reference US population (SIR = 1.05, 95%CI = 1.02–1.08, p-value < 0.05). The occurrence of second myeloid malignancies and second thyroid cancer were most notable across our latency periods. Among the most significant second primary malignancies by latency were malignancies of the appendix (SIR = 14.04, 95%CI = 5.65–28.93, p-value <0.05) at 2–11 months, the small intestine (SIR = 3.15, 95%CI = 1.76–5.2, p-value <0.05) at 12–59 months, and the urinary bladder (SIR = 1.63, 95%CI = 1.3–2.02, p-value <0.05) after 10 years of an OC diagnosis.ConclusionWomen with OC are at significant risk for the development of second primary malignancies across all sites, as compared to a reference US population, and may benefit from second primary malignancies site-specific screening post-diagnosis.