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FORMULATION OF CLINICAL RECOMMENDATIONS (GCP)

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KCE Webmaster Tue, 11/16/2021 - 17:41

Writing recommendations is one of the most important steps in developing a clinical guideline. (NICE, 2009) According to the GRADE system, a recommendation is depending on several factors: not only the level of evidence, but also the balance between harm and benefit, the patients’ values and preferences, and the cost of the intervention. These factors allow allocating a level of strength to the recommendation which has to be translated in the formulation of the recommendation.

In specific situations, the available literature provides no evidence, or that conflicting or poor evidence that it is not possible to draw clear conclusions. In these cases, several solutions exist: no recommendation, recommendation without grading, recommendation with low strength or an “only in research” recommendation (see Figure 1). The choice between these solutions is not easy.

This part of the process note aims to provide guidance and tips to formulate clinical recommendations with consistency. It is based on documents from other guideline developers as NICE, SIGN, IKNL, from the GRADE literature and a discussion between KCE experts involved in GCP or in data analysis. It is intended to be used by all experts (intern and extern) involved in the development of clinical guidelines.

Figure - Situations after the literature search

Figure - Situations after the literature search

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WHICH TYPE OF RECOMMENDATIONS?

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Patrice.Chalon Tue, 11/16/2021 - 17:41

Formulating a recommendation (even if the level of evidence is low) should always be the aim. The other options (not to formulate a recommendation, formulate a “only in research recommendation” or formulate a recommendation without grading) should be exceptions.

Recommendation with grading

The panellists should not be afraid with the formulation of recommendations even if evidence is poor. Absence of a statistically significant effect is no proof that an intervention does not work. It is only proven that an intervention doesn’t work if the confidence interval around the effect estimation excludes a minimally important difference or decision threshold. Even when confidence in effect estimate is low and/or desirable and undesirable consequences are closely balanced, GRADE encourages to make recommendations (inevitably weak) to avoid clinicians frustration with the lack of guidance. (Andrews et al., 2013) As the US Preventative Services Task Force states : “Even though evidence is insufficient, the clinician must still provide advice, patient must make choices, and policy makers must establish policies”.(Petitti et al., 2009)

No recommendation

Decede NOT to formulate a recommendation could be proposed2:

  • When the confidence in effect estimates is so low that the panellists feel a recommendation is too speculative.
  • When “although the confidence in effect estimates is moderate or even high, the trade-offs are so closely balanced, and the values and preferences and ressource implications not known or too variable, that the panel has great difficulty deciding on the direction of the recommendation”.

But as said above, choosing not to make recommendation might be an exception. And if the panel chooses to make no recommendation, the reason (low confidence in effect estimate or close balance between harm and benefit) should be specified.(Andrews et al., 2013)

“Only in research” recommendation

“Only in research” recommendation will be appropriate when 3 conditions are met(Andrews et al., 2013) :

  • There is insufficient evidence supporting an intervention for a panel to recommend its use;
  • Further research has a large potential for reducing uncertainty about the effects of the intervention;
  • Further research is deemed good value for the anticipated costs.

Recommendation without grading

In some cases, grading a recommendation can be superfluous, but the eligibility criteria to choose this option still have to be determined by the KCE and are currently under discussion.

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WORDING OF RECOMMENDATIONS - TIPS AND TRICKS

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Patrice.Chalon Tue, 11/16/2021 - 17:41

Recommendations must be decidable and executable. Do not use assertions of fact as recommendations.(Hussain et al, 2009)

Example of assertion: Suppressive therapy is effective for preventing recurrent infections.(strength of recommendation A-1)

Focus on the action (NICE, 2009)
Recommendation should begin with what needs to be done and should be as specific as possible about the exact intervention being recommended.

Prefer active voice for clarity: choose a verb as “offer”, “measure”, “advise”, “discuss”

Example:

  • Instead of “an intervention is recommended”, say “offer the intervention”
  • Instead of “an intervention may be offered”, say “consider offering the intervention”

Start with the verb

Exception: If recommendations differ for slightly different circumstances, it can be clearer to start with details of the patient group or other information: e.g. “If surgery is being considered, offer to…”

Use direct instructions assuming you are talking to the healthcare professional (HCP) who is working with the patient at that time.

Example: “Record the person’s blood pressure every 6 months”

Exception:

  •  Recommendations about service organization or for target group not HCP: “Care should be provided by a multidisciplinary team”
  • Recommendations concerning a specific type of HCP: “An occupational therapist should assess the patient”
  • Recommendation that use ‘must’ or “must not” because of legal aspects (see below)

Present recommendations in favour of a particular management approach rather than against an approach

Except if a useless or harmful therapy is in wide use (Andrews, 2013)

Clearly distinguish between the distinct concepts of quality evidence and strength of recommendation

Choose the verb according to the strength of recommendation

  • For strong recommendation, “Offer”, “Avoid”,…
  • For weak recommendations, we can add “Consider” before the verb

Add a level of evidence immediatly after each recommendation and whrite it in words

  • From “Very low level of evidence” to “High level of evidence”

Use no symbols to translate the strength of the recommendation.

Be concise, unambiguous and easy to translate into clinical practice(NICE, 2009)

Consider only one action by recommendation, or by bullet point in each recommendation.

To combine briefness and accuracy, word the recommendation in one sentence and put a short text aside (e.g. by clicking) with the rational supporting the recommendation. This rational could encompass the level of evidence and the other considerations issues.

For example the reason why the recommendation is not strong: ”The addition of a systemic anti-inflammatory drug can be considered, but apart from case series, there is currently no convincing evidence that it accelerates the healing process. Moreover the balance benefit/harm is not clear’

In other words, when we're not sure, the clinician is has the right to know on what basis.

Include what readers need to know.
Even if recommendations should be clear and concise, they should contain enough information to be understood without reference to supporting material.(NICE, 2009). Recommendations too vague to be implemented (e.g. “take a comprehensive history” or “a detailed physical examination”) are unhelpful.(Guyatt, 2011) “An ideal recommendation should explicitly or implicitly answers the questions : WHO should do WHAT to WHOM, UNDER WHAT CIRCUMSTANCES, HOW, and WHY?”(Hussain, 2009)

Define any specialized terminology or abbreviation

Define the target population unless it is obvious from the context

Specify the comparator unless it is obvious. Sometimes, the setting can also be important.

Include cross-references to other recommendations if necessary to avoid the need to repeat information such as treatment regimens or definitions of terms.

Emphasise the patient’s involvement

Use “offer” and “discuss” rather than “prescribe” or “give”.(NICE, 2009)

Use words as “people” or “patients” rather than “individuals”, “cases” or “subjects”.(NICE, 2009)

For people with mental health problems, prefer “services users” or “people” instead of “patients”

For people with chronic condition, use “people” rather than “patients”

For healthy pregnant women, do not use “patients”

In the text aside the recommendation, frame values and preferences statements for recommendations particularly sensitive to the patients, and for those for which values and preferences are less certain.(Andrews, 2013)

Example:

“This recommendation places relatively more weight on this x outcome despite the increased risk of this xx adverse event”.

“Patients who prefer to avoid surgery and the high rates of gastro-oesophageal reflux disease seen after surgery, and who are willing to accept a higher initial failure rate and long-term recurrence rate, can reasonably choose pneumatic dilatation”

Formulate each “research recommendation” as an answerable questions or a set of closely related questions.(NICE, 2009)

Use the PICO framework.

Example: “Is benzoyl peroxide or adapalene more clinically and cost effective at reducing the number of non-inflammatory lesions in the treatment of acne vulgaris in adolescents?”

Group the recommendations together in a summary section to facilitate their identification
Provide an explanations of the tips in the beginning of each report for limiting the risk of misunderstanding.

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