Quality assurance in drug demand reduction in European countries: an overview

Background: The EMCDDA, through its network of National Focal Points, collects information on the quality assurance systems for drugs-related interventions across European countries. European National Drug Strategies include recommendations for systems and approaches for the assurance of the quality of interventions.

Methods: We searched National Drug Strategies for elements related to quality assurance in drug demand reduction and summarised information through questionnaires administered to the EMCDDA Network of National Focal Points.

Results: In total, 15 National Drug Strategies and 60 questionnaires were analysed. Almost all the strategies include quality-related topics. Frequently, the Ministry of Health leads quality assurance although sometimes jointly with the Ministries of Education, Labour, Family and Social Welfare. Accreditation systems are common, but implemented in different ways. Training and education are widely provided, for the vast majority of countries, consisting of short-term training to keep professionals updated. Guidelines and Standards are gathering momentum as the major tools for the implementation of evidence-based recommendations and are usually available across countries.

Conclusions: Although the evidence base for interventions in drug demand reduction is becoming available and accepted, attention needs to be given to implementation issues. The European countries are rapidly moving towards paying greater attention to the quality of interventions.     

State insurance mandates and off‐label use of chemotherapy

Access to cancer drugs used off‐label is important to cancer patients but may drive up healthcare costs with little evidence of clinical benefit. We hypothesized that state health insurance mandates for private insurers to provide coverage for off‐label use of cancer drugs cause higher rates of off‐label use. We used Truven MarketScan data from 1999 to 2007 on utilization of 35 infused chemotherapy drugs in private health plans in the United States, covering the period when eight states implemented off‐label coverage laws. We studied trends in off‐label use of drugs, distinguishing between appropriate and inappropriate off‐label use according to drug compendia, and estimated difference‐in‐difference regressions of the effect of state laws on off‐label use. We estimate 41% of utilization was off‐label, including 17% of use conservatively defined as inappropriate. Trends show gradual declines in off‐label use over time. We also find no discernable effect of state laws mandating coverage of off‐label use of cancer drugs on utilization patterns under multiple empirical specifications. Our conclusion is that policymakers should consider shifting away from mandating coverage as a way to ensure access to drugs off‐label and towards incentivizing adherence to clinical practice guidelines to improve the quality and value of off‐label use.     

Cochrane协作网结直肠癌组的结直肠肿瘤证据

截至Cochrane图书馆2008年第2期，Cochrane协作网结直肠癌组目前已完成的25篇与结直肠肿瘤相关的系统评价涉及结直肠肿瘤预防、镜检诊断、内外科治疗、预后、随访等方面。Cochrane系统评价肯定了非甾体抗炎药的预防作用，染色内镜的诊断价值，腹腔镜手术的短期效果，全直肠系膜切除术辅助腹腔镜手术的疗效等；质疑了纤维素在结直肠肿瘤预防、结直肠癌术前机械肠道准备、术后常规引流的意义。某些课题如中药在化疗中的作用，由于所纳入的研究质量不高而未能得出非常可靠的证据。本文试图通过介绍Cochrane协作网结直肠肿瘤的系统评价成果，向国内同行传递目前结直肠肿瘤的高级别临床证据，并提示结直肠肿瘤领域的研究方向。     

An approach to evidence-based therapeutic apheresis

This review is derived from a memorial lecture honoring Dr. Francis Morrison, a former President of the American Society For Apheresis (ASFA). The author had numerous professional contacts with Dr. Morrison through ASFA in the early 1990s, having served with him on the Board of Directors and followed him as President, and also came to know him well on a personal level. Professionally, Dr. Morrison stood out as a courtly gentleman with a marvelous baritone voice whose ability to facilitate organization contributed to a growing sense of dignity and purpose in the affairs of the society. On the personal side, however, there wasn't an ounce of pretension in him. He was accessible and down-to-earth; a genuine character with an active and appealing sense of humor. Not surprisingly, he seemed to have a wealth of insight and "common sense," and since the topic of this study is a kind of common sense approach to assessing the effectiveness of therapeutic apheresis, it seems a fitting way to honor his memory.     

Clinical practice guidelines in pediatric anesthesia: What constitutes high‐quality guidance?

The explosion of scientific evidence has outstripped the ability of individual clinicians to acquire, process, and apply it within a clinical context. Clinical practice guidelines bridge the gap between this large body of evidence and clinical practice by translating evidence into recommendations. As such, they are an important extension of the evidence‐based medicine paradigm. Guidelines promise to translate evidence into actionable clinical recommendations. However, this promise can only be realized if they are both useful and trustworthy. As the number of guidelines increases users’ question their role, the quality of the scientific evidence behind them and the strength of the recommendations made. In this article, we provide definitions and outline the features of the common forms of clinical guidance. We then describe the essential characteristics of good quality clinical guidance and outline initiatives aimed at improving quality. Specific issues and limitations related to guideline development in perioperative care of children are discussed. Finally, two clinical guidance documents, published recently in Pediatric Anesthesia, are discussed based upon these criteria.     

Patients’ and parents’ views about lower limb orthopaedic surgery for ambulant children and young people with cerebral palsy: a qualitative evidence synthesis

PurposeThe article identifies the aspects of health and outcomes that are considered important from the perspective of ambulatory children with cerebral palsy (CP) and their parents regarding lower limb orthopaedic surgery and explores how they experience surgical interventions.MethodsFour databases (Embase, MEDLINE (Ovid), CINAHL and PsycINFO) were searched from inception to 11 April 2020. Studies were included if they: 1) they involved children or young adults diagnosed with ambulant CP or their family, 2) participants had experience with lower limb orthopaedic surgery and 3) studies employed qualitative research methods. The Critical Appraisal Skills Programme was used to appraise identified studies. The ‘Best-fit framework’ synthesis approach was used by applying the International Classification of Functioning-Children and Youth (ICF–CY) linking rules and thematic synthesis. The review process was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.ResultsSix studies were included. Four themes were generated which were linked to the ICF–CY framework: Body function and structure, Activity and participation, Environmental factors, Personal factors, as well as non-ICF–CY themes including Emotional well-being and Goal setting. Important surgical outcomes identified were pain, fatigue, movement-related function, mobility, walking ability, community life, emotional well-being, and adequate provision of public and health services.ConclusionThese findings are important for understanding patient-centred outcomes in lower limb ortho-paedics surgery and providing focus for future interventional studies aimed at improving outcomes of importance to children with CP. These findings highlight the importance of long-term support to help people negotiate the challenge of surgical regimes and to achieve good outcomes after orthopaedic surgery. The outcomes identified will contribute to the development of a core outcome set in this field.Level of evidenceIII     

化疗致味觉改变评估及护理的最佳证据总结

目的总结化疗所致味觉改变(CITA)评估及护理的相关证据,为临床护理人员对味觉改变展开规范化评估和管理提供参考。方法针对CITA的护理提出循证问题,通过美国国家综合癌症网络(NCCN)、Best Practice、美国指南网(NGC)、澳大利亚循证卫生保健中心(JBI)、Cochrane数据库检索近10年CITA的相关研究。对符合质量标准的文献进行资料提取和证据归纳。结果纳入8篇文献,包含2篇证据总结、1篇最佳实践推荐及5篇系统评价。总结出在特定临床情景下具备可行性及适宜性的最佳证据共7条,包括CITA的筛查与评估、预防及干预等。结论护理人员可遵循最佳证据来完善肿瘤内科CITA的管理,促进化疗相关症状的循证实践。