Gopalakrishna Gowri, Leeflang Mariska M G, Davenport Clare, Sanabria Andrea Juliana, Alonso-Coello Pablo, McCaffery Kirsten, Bossuyt Patrick, Langendam Miranda W
Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Public Health, Epidemiology and Biostatistics, University of Birmingham, Birmingham, UK.
BMJ Open. 2016 Sep 16;6(9):e010549. doi: 10.1136/bmjopen-2015-010549.
Development of medical test guidelines differs from intervention guideline development. These differences can pose unique challenges in building evidence-based recommendations to guide clinical practice. The aim of our study was to better understand these challenges, explore reasons behind them and identify possible solutions.
In this qualitative study, we conducted in-depth interviews between February 2012 and April 2013 of a convenience sample of 17 European guideline developers experienced in medical test guideline development.
We used framework analysis with deductive and inductive approaches to generate the themes from the interviews. We kept interpretation grounded in the data.
Guideline developers acknowledged that inclusion of patient important outcomes in their guideline development was necessary but lacking. This and other challenges raised fell into 3 broad and overlapping domains: methodological issues, resource limitations and a lack of awareness on the need for evidence that links testing to patient outcomes. Education was mentioned as a key solution to increase awareness and address the resources limitations mentioned.
Challenges guideline developers face were interlinked across the domains of methodological issues, resource limitations and a lack of awareness. Solutions that addressed these challenges in parallel are needed. Raising awareness, education and training of relevant stakeholders such as medical doctors, funders and regulators to look beyond test accuracy is key to having a long-term resolution to the issues faced in medical test guideline development.
医学检验指南的制定与干预指南的制定有所不同。这些差异在构建基于证据的建议以指导临床实践方面可能带来独特的挑战。我们研究的目的是更好地理解这些挑战，探究其背后的原因并确定可能的解决方案。
在这项定性研究中，我们于2012年2月至2013年4月对17名在医学检验指南制定方面有经验的欧洲指南制定者进行了便利抽样的深入访谈。
我们采用框架分析，运用演绎和归纳方法从访谈中提炼主题。我们的解读以数据为依据。
指南制定者承认在其指南制定过程中纳入患者重要结局是必要的，但却有所欠缺。所提出的这一挑战及其他挑战可归为3个广泛且相互重叠的领域：方法学问题、资源限制以及缺乏对将检验与患者结局相联系的证据的必要性的认识。教育被提及是提高认识并解决所提到的资源限制的关键解决方案。
指南制定者面临的挑战在方法学问题、资源限制和缺乏认识等领域相互关联。需要并行解决这些挑战的方案。提高医生、资助者和监管者等相关利益者对超越检验准确性的认识、开展教育和培训，是长期解决医学检验指南制定中所面临问题的关键。
