Athena Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Centre for Trials Research, Cardiff University, Cardiff, UK.
J Eval Clin Pract. 2022 Feb;28(1):49-56. doi: 10.1111/jep.13625. Epub 2021 Oct 6.
At the start of the COVID-19 pandemic, guidance was needed more than ever to direct frontline healthcare and national containment strategies. Rigorous guidance based on robust research was compromised by the emergence of the pandemic and the urgency of need for guidance. Rather than aiming to "get guidance right", guidance developers needed to "get guidance right now".
To examine how guidance developers have responded to the need for credible guidance at the start of the COVID-19 pandemic.
An exploratory mixed-methods study was conducted among guidance developers. A web-based survey and follow-up interviews were used to examine the most pertinent challenges in developing COVID-19 guidance, strategies used to address these, and perspectives on the implications of the COVID-19 pandemic on future guidance development.
The survey was completed by 46 guidance developers. Survey findings showed that conventional methods of guidance development were largely unsuited for COVID-19 guidance, with 80% (n = 37) of respondents resorting to other methods. From the survey and five follow-up interviews, two themes were identified to bolster the credibility of guidance in a setting of extreme uncertainty: (1) strengthening end-user involvement and (2) conjoining evidence review and recommendation formulation. 70% (n = 32) of survey respondents foresaw possible changes in future guidance production, most notably shortening development time, by reconsidering how to balance between rigour and speed for different types of questions.
"Getting guidance right" and "getting guidance right now" are not opposites, rather uncertainties are always part of guidance development and require guidance developers to balance scientific robustness with usability, acceptability, adequacy and contingency. This crisis points to the need to acknowledge uncertainties of scientific evidence more explicitly and points to mechanisms to live with such uncertainty, thus extending guidance development methods and processes more widely.
在 COVID-19 大流行开始时，非常需要指导来指导一线医疗保健和国家遏制策略。由于大流行的出现和对指导的迫切需求，基于强有力研究的严格指导受到了影响。指导制定者的目标不是“使指导正确”，而是“现在就使指导正确”。
研究 COVID-19 大流行开始时指导制定者如何应对对可信指导的需求。
在指导制定者中进行了一项探索性混合方法研究。使用网络调查和后续访谈来研究制定 COVID-19 指导的最相关挑战、解决这些挑战的策略，以及对 COVID-19 大流行对未来指导制定的影响的看法。
46 名指导制定者完成了调查。调查结果表明，传统的指导制定方法在很大程度上不适合 COVID-19 指导，80%（n=37）的受访者转而采用其他方法。通过调查和五次后续访谈，确定了两个主题来增强在极端不确定情况下指导的可信度：（1）加强最终用户的参与，（2）结合证据审查和建议制定。70%（n=32）的调查受访者预计未来的指导制作可能会发生变化，最显著的是通过重新考虑如何在不同类型的问题之间平衡严谨性和速度，从而缩短开发时间。
“使指导正确”和“现在就使指导正确”并非相互矛盾，而是不确定性始终是指导制定的一部分，需要指导制定者在科学稳健性与可用性、可接受性、充分性和应急性之间取得平衡。这场危机表明，需要更明确地承认科学证据的不确定性，并指出应对这种不确定性的机制，从而更广泛地扩展指导制定方法和流程。
