6 Simple Rules for Creating a Plain Language Summary of a GRADE Guideline Recommendation

While seasoned clinicians and methodheads may consider the nuances of clinical guideline development everyday fare, there is generally a lack of awareness among the public about the implications and use of guidelines. In addition, there is some evidence of public concern that guidelines may be used to ration care as well as public confusion about how they should be applied to an individual's unique needs. The translation of guideline recommendations into plain language, however, may help improve public knowledge and awareness of the applications and implications of guidelines.

In a new paper published in the Journal of Clinical Epidemiology, Santesso and colleagues set out to develop a template for communicating guideline recommendations as well as explore public attitude around guidelines. First, the authors conducted semi-structured focus groups to gather information about general perceptions and opinions regarding guidelines. Then, these insights were used to develop a plain language template which was user-tested. The template was then revised into a final version. During the process, a few key themes emerged, including:

• an upfront and clear description of the population/individuals to whom the guideline applies
• a section detailing topics and questions to bring up with one's health care provider
• definitions surrounding the strength of the recommendation, and further considerations for decision-making around conditional recommendations
• formatting that makes use of bullets and tables rather than blocks of text

These themes informed the development of the final template, which includes six major items:

1. the recommendation, its strength (with a symbol), and an explanation 
2. the population/individuals to whom the recommendation applies
3. rationale for the strength of the recommendation
4. additional considerations when using the recommendation
5. benefits and harms 
6. implications, what a patient can do, and questions or topics to discuss with one's health care provider

Santesso, N., Wiercioch, W., Barbara, A.M., Dietl, H, and Schünemann, H.J. (2021). Focus groups and interviews with the public led to the development of a template for a GRADE plain language recommendation. J Clin Epidemiol, in-press.

Manuscript available at the publisher's website here. 

Re-analysis of a systematic review on injury prevention demonstrates that methods do really matter

How much of a difference can methodological decisions make? Quite a bit, argues a new paper published in the Journal of Clinical Epidemiology. A re-analysis of a 2018 meta-analysis on the role of the Nordic hamstring curl (NHE) on injury prevention, the study outlined and then executed several methodological changes within the context of an updated search and found that the resulting magnitude of effect - and strength of recommendations using GRADE - were not quite as dazzling as the original analysis.

Impellizzeri and colleagues noted several suggested changes to the 2018 paper, including:

• limiting the meta-analysis to higher-level evidence (randomized controlled trials) when available,
• clarifying the interventions used in the included studies and being cognizant of the effect of co-interventions (for instance, when NHE was used alone versus in combination with other exercises as part of an injury reduction program),
• being careful not to "double-dip" on events (i.e., injuries) that recur in the same individual when presenting the data as a risk ratio
• discussing the impact of between-study heterogeneity when discussing the certainty of resulting estimates,
• presenting the lower- and upper-bounds of 95% confidence intervals for estimates of effect in addition to the point estimates, and
• taking the limitations of the literature and other important considerations into account when formulating final summaries or recommendations (for instance, using the GRADE framework)

The authors ran an updated systematic search but excluded non-randomized controlled trials or studies that incorporated other exercises with the NHE in the intervention group. Risk of bias was assessed using the Cochrane tool for randomized studies. The overall certainty of evidence as assessed using GRADE was rated "low," although given that concerns regarding risk of bias, inconsistency, and imprecision were noted, the certainty may range to "very low" following the standard GRADE framework. The forest plot of the updated analysis can be seen below.

The results of the updated analysis show that rather than reduce the risk of hamstring injury by 50%, the range of possible effects was too large to draw a conclusion on the effectiveness of this intervention, and only a conditional recommendation can be warranted.

Impellizzeri, F.M., McCall, A., and van Smeden, M. (2021). Why methods matter in a meta-analysis: A reappraisal showed inconclusive injury preventive effect of Nordic hamstring exercise. J Clin Epidemiol, in-press.

The manuscript is available at the publisher's site here.