How to write a guideline

In this article, we shed light on the process behind the creation of ESE Clinical Practice Guidelines, from formulating clinical questions to developing clinical recommendations.

ESE has a Clinical Practice Guideline programme, aiming to publish at least one (revised) guideline yearly. The first ESE guideline was published in 2015; the first revision of an ESE guideline (adrenal incidentalomas) has recently been published. The guidelines are widely read: the paper concerning adrenal incidentalomas was downloaded 21 330 times in a year.

Workflow

ESE’s Clinical Practice Guidelines aim to provide recommendations for patient care for specified endocrine conditions (see www.ese-hormones. org/publications/guidelines/about-our-guidelines). Guideline topics are directed by the ESE Clinical Committee, with input from ESE members. The topics ideally address areas not previously covered by other influential endocrine societies/specialty organisations, or areas where available recommendations are not applicable to the European standard of care.1

A dedicated working group, consisting of experts in the field and supported by a methodologist, is appointed for each guideline by the Clinical Committee. First drafts of guidelines are reviewed by ESE members and relevant parties (such as patient support groups and other specialist societies) before publication, and are presented during the Society’s annual Congress (ECE). Where considered beneficial, patient leaflets are prepared alongside the guidelines, to provide patients with assistance in understanding and managing their condition.

Methodological process

The guidelines use GRADE (Grading of Recommendations Assessment, Development and Evaluation) as a methodological base. This is a systematic approach for synthesising evidence and grading of recommendations.2

The first methodological step for the working group is defining clinical questions to be addressed in the guideline.3 These clinical questions form the basis of a systematic literature search. An example of such a clinical question is: which biochemical test predicts clinically relevant adrenal insufficiency optimally in patients using high dose corticosteroids?

After the search is performed and relevant articles are included, evidence is synthesised, for example by estimating the average effect for a specific outcome. Also, the quality of the evidence is graded in a standardised manner using GRADE, which results in a summary rating across studies for each outcome. Four categories are used: high, moderate, low and very low quality.

The quality of evidence forms a core element of the final recommendations. The second element is the balance between desirable and undesirable outcomes, the third element is values and preferences (patient preferences, goals for health, costs etc.).4 For example, a specific test or imaging modality might have the best diagnostic performance. However, if the test is very expensive or not widely available, the guideline may not recommend it as first choice.

Consensus on final recommendations is reached upon discussion within the working group. Minority positions are taken into account in the rationale behind recommendations.

The final recommendations are worded as recommend (strong recommendation) or suggest (weak recommendation). For a strong recommendation, it can be stated that reasonably informed persons (clinicians, politicians and patients) would act in accordance with the recommendation, whereas for a weak recommendation most persons would still act in accordance with the guideline, but a substantial number would not.4 The quality of evidence behind the recommendations is classified as very low (⨁◯◯◯), low (⨁⨁◯◯), moderate (⨁⨁⨁◯) and strong (⨁⨁⨁⨁).3

When there is no high quality evidence

In an ideal setting, guidelines are based on evidence from randomised trials and accompanied by strong recommendations.1 Unfortunately, for many areas in endocrinology, high quality evidence is scarce or even nonexistent. Another scenario is that high quality evidence is available, but does not translate into a strong recommendation, for instance because the outcome under study is judged as not important.3 Hence, standardised quality judgement still does not eliminate the need for clinical judgement.2

These limitations in evidence challenge a guideline working group. However, recommendations still have to be made, based on the simple fact that treatment decisions for patients have to made. The lack of solid evidence and the fact that the recommendation concerned is based on good clinical practice are emphasised in the guideline. Of note, good practice recommendations are not graded, since the lack of apparent evidence might wrongly suggest the lack of a good rationale for clinical practice.5 One example is that it is good clinical practice to treat patients with Addisonian crises with i.v. glucocorticoids, even though there are no randomised controlled trials showing its superiority over placebo.

In addition, all ESE guidelines incorporate a paragraph with uncovered gaps in clinical knowledge and specified suggestions for future research.

In summary

ESE’s Clinical Practice Guidelines are produced through a standardised process; the methodological part is based on GRADE. Lack of (high quality) evidence does not automatically mean lack of clinical recommendations, but merely uncovers literature gaps, leading to (ungraded) good practice recommendations and directing future research.

You can access ESE’s Clinical Practice Guidelines at www.ese-hormones.org/ publications/guidelines

Leonie T van Hulsteijn and Olaf M Dekkers The Netherlands

Leonie van Hulsteijn is a post-doc who works for ESE in the role of Clinical Guideline Methodologist.

REFERENCES

1. Dekkers & Burman 2015 European Journal of Endocrinology 173 E1−E2 https://doi.org/10.1530/EJE-15-0625

2. Guyatt et al. 2011 Journal of Clinical Epidemiology 64 383–394 https://doi.org/10.1016/j.jclinepi.2010.04.026

3. Bollerslev et al. 2015 European Journal of Endocrinology 173 G1−G20 https://doi.org/10.1530/EJE-15-0628

4. Andrews et al. 2013 Journal of Clinical Epidemiology 66 719−725 https://doi.org/10.1016/j.jclinepi.2012.03.013

5. Guyatt et al. 2015 Journal of Clinical Epidemiology 68 597–600 https://doi.org/10.1016/j.jclinepi.2014.12.011