Making recommendations: Practical Considerations

1. Making recommendations:Practical Considerations Nov 15 2006 HHT Guidelines, Kingbridge Valerie Palda, MD, MSc

2. Process so far… • Some evidence based recommendations • Some consensus • Evidence-based recommendations will be discussed in detail at small group discussions • All recommendations will be presented to and voted on by large group session • Recommendations with substantial disagreement will be discussed further

3. Recommendations • Reflect the evidence • Consider values • Are clearly worded

4. Reflect the evidence • For each statement • What is the level of evidence? • CTF classification • Is recommendation consistent with the evidence? • e.g. Evidence suggests test is not sensitive, but recommendation is made in favour of test

5. Study designs and how they correspond to levels of evidence I At least one well-designed RCT II-1 Well-designed controlled trials without randomization II-2 Well-designed cohort or case-control analytic studies, preferably from more than one centre or research group II-3 Comparisons between times or places with or without the intervention: dramatic results from uncontrolled studies could be included here IIIOpinions of respected authorities, based on clinical experience; descriptive studies or reports of expert committees

6. Reflect the evidence • For each statement • What is the level of evidence? • CTF classification • Is recommendation consistent with the evidence? • e.g. Evidence suggests test is not sensitive, but recommendation is made in favour of test WHY MIGHT THIS BE A VALID RECOMMENDATION?

7. Consider values • Very important when making consensus recommendations • What are “values”? • sometimes called “preferences” if asking patient, “values” if research or guideline developer • Usually apply to outcomes e.g. HRT

8. Other values • Cost • Feasibility

9. How values might affect recommendations • Which is more important: • stroke or bleed? (depends on whom you ask) • preventing a potential disease outcome in an asymptomatic person, or not risking a procedural complication? • recommending a test that’s available and getting it done, or recommending the unavailable test for which there is the best evidence?

10. Numbers – are NOT values, but affect recommendations • Baseline risks of outcomes • Benefit of treatment • Harms of treatment • How certain is the point estimate of all of these? • Size of studies • Quality of studies

11. In the absence of published evidence… • recommendation developers bring their own values and numbers to the table • A sense of how often that patient bleeds • An idea of the complication rate of the procedure (also dependent on most recent) • Their own view of how bad a bleed can be • This may be different from their neighbour at the table, and lead to disagreement about the recommendation

12. When making a recommendation: • Explicitly address in the group: • Level of evidence • Values at stake • Baseline risks, benefits and harms of treatment • Precision of those estimates (how sure are we?) • Other factors: e.g. availability

13. When there is a disagreement: • Try to identify which component is the cause • Establish consensus. If cannot, may not be able to make a recommendation at this time

14. Group leaders will note • Precise wording of the recommendation • Main points of discussion • Important clinical considerations (these often stem from numbers, values and costs) • Table 2 in the ATS “GRADE” paper

15. Writing the recommendation: Be clear: Active tense –“The expert panel recommends the clinician do THIS…” Include the outcome –“to reduce THIS OUTCOME…” Include the level of evidence- “…Level II” Make a strength of recommendation “… weak recommendation”