Methodological Quality Assessment of Meta-analyses and Systematic Reviews of the Relationship Between Periodontal and Systemic Diseases

ObjectivesThe aims of this article are to identify all the published systematic reviews (SRs) and meta-analyses (MAs) that studied the relationship between periodontal and systemic diseases and to assess their quality using 2 scales (the Overview Quality Assessment Questionnaire [OQAQ] and A Measurement Tool to Assess Systematic Reviews [AMSTAR] checklist).MethodsFor SRs and MAs to be included, they should have investigated one of the following systemic diseases: pulmonary conditions, cardiac conditions, endocrine conditions, cancer, blood disorders, psychological conditions, anxiety, depression, mood disorders, and several other diseases. Two investigators screened MEDLINE via PubMed, Embase, Scopus, Web of Science, and the Cochrane Database of Systematic Reviews. The tools used to evaluate quality were the AMSTAR scale and OQAQ. The protocol was prospectively registered in PROSPERO (CRD42018102208).ResultsThe search strategy found 691 unique articles, 42 of which met the eligibility criteria and were included in this review. Diabetes mellitus was the most investigated disease (14 out of 42 studies), followed by obesity (11 studies) and cardiovascular diseases (5 studies). A total of 40 reviews reported on the characteristics of included studies, and, as per the AMSTAR scale, 39 reviews had an a priori design. The number of reviews that fulfilled the status of publication criterion was the lowest (7 reviews only), followed by the number used in the assessment of publication bias (11 reviews). The number of high-quality reviews was higher with the OQAQ than with the AMSTAR checklist (33 vs 25 studies), but the AMSTAR showed a higher number of medium-quality reviews than the OQAQ (14 vs 6 studies). Both showed the same number of low-quality reviews.ConclusionsHigh-quality SRs and MAs are crucial to understanding the relationship between systemic and periodontal diseases. Medical practitioners must be able to inform patients about oral health and specific periodontal health concerns.     

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.     

Credentialed Persons, Credentialed Knowledge

The vast experimental literature on human error agrees with history of medicine, folklore, and superstition In discrediting knowledge claims based solely on anecdotal impressions. Since clinical experience consists of anecdotal impressions by practitioners, tt Is unavoidably a mixture of truths, half-truths, and falsehoods. The scientific method is the only known way to distinguish these, and it is both unscholariy and unethical for psychologists who deal with other persons' health, careers, money, freedom, and even life itself to pretend that clinical experience suffices and that quantitative research on diagnostic and therapeutic procedures is not needed. Disputes about philosophy of science (e.g., logical positivism) are irrelevant to this issue, which is simply one of distinguishing knowledge claims that bring reliable credentials and others that do not.     

浅谈电子文档的原始性和真实性及法律证据作用

该文针对电子文件或档案的原始性真实性与电子档案的法律证据作用,参考了最新的研究结果,并提出了自己的思考,逐步探讨了它们的涵义及关系.     

从医务人员的证据意识谈举证责任倒置

文章从剖宫产术后伴发腰腿痛病例分析入手，认为举证责任倒置就在我们诊疗工作中，就在我们协调医患关系的过程中。因此需要在临床实践中去感悟举证责任置的深刻含义，从而树立证据意识，做好证据的收集与保存工作，一旦发生诉讼有证为据，并由此提出了“医学证据学”的构想，而医学证据的特点有待进一步深入研究。