Tool for developing population-specific recommendations

1. Introduction

Evidence-based guideline development begins with the systematic search for scientific evidence, usually in response to clinical care gaps experienced in practice. The conclusions from the literature are then translated into specific recommendations for practice with various considerations playing a role. It is important to note that the evidence on which the recommendations are based is applicable at group level, meaning the ‘average’ patient who meets the research inclusion and exclusion criteria. In reality, subgroups often exist that may differ from the study population. This may be a result of the severity or manifestation of the disease, genetic background, multimorbidity, comorbidity or concomitance, culture-driven habits or specific patient wishes. The recommendations in the guideline are intended to provide specific guidance for decision-making processes in practice, including decision-making for different patient subgroups. This can be achieved by systematically considering those subgroups from the beginning of the guideline development process.

2. Objective of this tool

This tool is a checklist for developing recommendations that are as specific as possible and focus mainly on the most common subgroups found in practice. The checklist can be used to fine tune recommendations in both the development of new guidelines and the revision of existing guidelines. If evidence is lacking for specific subgroups, guideline developers should use practical knowledge and experience when drafting the population-specific recommendations. A tool is also available for sex-specific aspects (see Tool considering sex differences in guideline development). For formulating action-focused recommendations, see Rosenfeld & Shiffman, 2009 and NICE, 2009.

3. Checklist for ‘Developing population-specific recommendations’

This checklist consists of a number of questions (see text box below) that a development group can ask when formulating recommendations. If they answer one or more of these questions in the affirmative, the development group will need to consider formulating different recommendations for the different subgroups.

The checklist can also be used in the phases prior to the recommendation development phase. The development group will need to consider the patient population and variations when first defining the topic and drafting the initial questions. In addition, they should consider the characteristics and composition of the patient population when preparing the literature research strategy and defining the inclusion and exclusion criteria. The same applies to interpreting the literature, at which stage they will need to determine whether the study population resembles the characteristics and composition of the patient population in real-world settings. If this is not the case, the evidence is categorised as ‘indirect evidence’ and assigned less weight than direct evidence. The guideline can specify when information about the effects on different subgroups is lacking, meaning the effects should be closely monitored. The guideline preferably also states when applying ‘general’ recommendations to subgroups in practice.

Drafting a checklist for population-specific recommendations

Are there any relevant biological differences in the patient population that could lead to differences in effectiveness and side effects or adverse effects of the intervention?
Consider the following factors:

  • Age (e.g. in the treatment of atrial fibrillation and prevention of cardiovascular diseases)
  • Sex (e.g. osteoporosis: see Tool considering sex differences in guideline development)
  • Ethnicity (e.g. reduced effectiveness of certain groups of antihypertensive drugs in people with black skin colour)
  • Metabolic disorders (e.g. lactose intolerance in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency)

Is there any relevant comorbidity or comedication that affects the effectiveness and side effects of the intervention?
Consider the following aspects:

  • Prevalence of most common comorbidity
  • Concordant (e.g. diabetes mellitus and hypertension) and discordant comorbidities (e.g. rheumatoid arthritis or COPD)
  • Nutritional circumstances
  • Decreased kidney or liver function
  • Addictions and psychiatric morbidity

Are there differences in the characteristics of the patient population in relation to the health care setting and system?
Consider the following aspects:

  • Primary care patient population (with or without a gatekeeper function) versus secondary care population
  • Outpatient versus hospital population
  • Acute care (emergency) versus chronic care
  • Specialist versus super specialist care

Are there any relevant social or cultural differences in the patient population that could influence the client’s/patient’s cooperation in the intervention ('compliance')?
Think of the following factors:

  • Level of education and literacy (e.g. in educational interventions)
  • Work status and economic capacity (e.g. regarding financial contributions by patient)
  • Living situations (e.g. presence or absence of informal caregivers)
  • Ethnicity (e.g. in psychotherapy)
  • Culture/religion (e.g. rejection of interventions by Jehovah's Witnesses)
  • Ethical standards and values (e.g. equality of men and women, autonomy)

4. Literature

  • Dans AL, Dans LF, Guyatt GH, Richardson S. Users' guides to the medical literature: XIV. How to decide on the applicability of clinical trial results to your patient. Evidence-Based Medicine Working Group. JAMA 1998; 279: 545-9.
  • Integraal Kankercentrum Nederland. Checklisten ‘Overige overwegingen’ en ‘Formuleren van aanbevelingen’, april 2011.
  • National Institute for Health and Clinical Excellence (January 2009) The guidelines manual. London: National Institute for Health and Clinical Excellence.
  • Rosenfeld RM, Shiffman RN. Clinical practice guideline development manual: a quality-driven approach for translating evidence into action 2009.
  • Werkgroep Richtlijn voor Richtlijnen. Richtlijn voor Richtlijnen. Den Haag: Regieraad Kwaliteit van Zorg, 2012.