Tool for the analysis of clinical care gaps

1. Introduction

To ensure that guidelines are properly aligned with their field, it is important that they are based on current problems, or clinical care gaps, found in that field of work. Clinical care gaps are experienced by health care professionals as well as patients and other stakeholders such as administrators, policymakers, insurers and the government. These clinical care gaps may relate to topics for which no guidelines currently exists or a topic for which the existing guidelines offer no solution. The clinical care gaps may require the development of new guidelines or the revision of existing guidelines. The choices that a guideline development group makes when defining a topic will determine what is or is not addressed in the guidelines and to what extent the guidelines meet the needs of the intended users. After defining the topic, the next stage is to formulate the topic and its scope, after which the development group will identify and analyse the clinical care gaps. Following this, they will decide on the development of the guideline. If they consider a particular guideline to be the best solution for the clinical care gap in question, they will then translate the clinical care gap into concrete review questions to which the guideline must provide the answers. It is often unclear to a guideline development group how to determine the guideline scope and how to select clinical care gaps. This tool provides recommendations for the preliminary research or preparation phase of guideline development and revision. The tool regards the stages of identifying, analysing and ultimately selecting the clinical care gaps as an independent process that occurs before any planned guideline project. In addition to developing guidelines, the selected clinical care gap can also be addressed through training or by formulating a viewpoint or recommendation.

2. Objective of this tool

This tool supports the following processes:

  1. defining the scope;
  2. identifying the clinical care gaps;
  3. analysing the clinical care gaps;
  4. selecting and prioritising the clinical care gaps.

The tool can also be used during the preliminary research or the preparation phase to help decide whether the most appropriate method for solving the clinical care gap is guideline development or revision.

3. Step-by-step plan/decision tree

NEW GUIDELINE GUIDELINE REVISION

PHASE 1:

DETERMINING THE SCOPE

STEP 1: SELECTION OF TOPIC

Based on clinical uncertainty, disease burden, health gains, incidence/prevalence, evidence availability, costs, feasibility, implementation aspects, patient safety, etc.

 


STEP 1: GUIDELINE REVISION

Reason for revision:

  • Availability of new evidence or considerations;
  • New clinical care gaps identified when implementing the guideline;
  • Expiry of a predetermined period for guideline revision.

STEP 2: MAPPING THE TOPIC

  • Short desk research on prevalence, incidence, costs, etc.
  • Collecting existing national, international and regional guidelines, work agreements and protocols;
  • Determining the preliminary scope, patient target group and professional target group.

STEP 2: MAPPING THE TOPIC

  • Collecting existing national, international and regional guidelines, work agreements and protocols;
  • Determining which parts of the guideline need to be revised.

PHASE 2:

SELECTING CLINICAL CARE GAPS THAT REQUIRE DEVELOPMENT

STEP 3: IDENTIFYING THE CLINICAL CARE GAPS

  • Done in consultation with experts and experienced parties on the topic concerned (e.g. professionals from the field, patients and patient representatives, professionals from related fields, policymakers, health insurers, government, owners of existing guidelines, scientists and implementing organisations);
  • Possible methods: brainstorming sessions, literature review, analysis of recorded data, interviews/focus groups with care providers and/or patients, surveys among care providers and/or patients, digital discussion forums, web-based inventories, etc.
STEP 3: IDENTIFYING THE CLINICAL CARE GAPS
  • Done in consultation with experts and experienced parties on the topic concerned (e.g. professionals from the field, patients and patient representatives, professionals from related fields, policymakers, health insurers, government, inspectorate, owners of existing guidelines, scientists and implementing organisations);
  • PO box for guideline commentary and feedback from the field;
  • Possible methods: brainstorming sessions, literature review, analysis of recorded data, interviews/focus groups with care providers and/or patients, surveys among care providers and/or patients, digital discussion forums, web-based inventories, etc.

STEP 4: ANALYSIS OF CLINICAL CARE GAPS

  • Classification/grouping of themes;
  • Identifying facilitating and obstructing factors with regard to implementation.

STEP 4: ANALYSIS OF CLINICAL CARE GAPS

  • Analysing the parts of the guidelines that need to be revised.

STEP 5: SELECTING/PRIORITISING CLINICAL CARE GAPS

Done by experts on the topic concerned (e.g. professionals and patients from the field, professionals from related fields, policy makers, health insurers, government, owners of existing guideline , scientists and implementing organisations);

PHASE 3:

ADDRESSING CLINICAL CARE GAPS

STEP 6: CHOICE OF METHOD FOR ADDRESSING SELECTED CLINICAL CARE GAPS

Possible outcomes:

  1. development of new guidelines;
  2. modification, revision or elimination of existing guidelines;
  3. different approach to addressing selected guideline, e.g. collaboration agreements, organisational or administrative measures, and laws and regulations.

CHOICE FOR GUIDELINE DEVELOPMENT OR REVISION: INFORMATION TRANSFER TO GUIDELINE DEVELOPMENT GROUP:

  1. parties participating in the analysis of clinical care gaps and which clinical care gaps were submitted by which party/parties;
  2. facilitating and obstructing factors with regard to implementing the new/revised guideline;
  3. problems anticipated in future development/revision of the guideline with regard to conflicting ideas or interests of the different parties.

Figure 1: step-by-step plan/decision tree for approach to preliminary research about clinical care gaps in practice

4. Phase 1: Determining the scope

4.1 Step 1: Topic selection

First, a comprehensive identification of possible topics must take place. It is important to expand the level of support and involve different perspectives. It is therefore recommended that the relevant patient organisations, as well as the care providers, be involved in selecting the topic. It may also be decided that insurance representatives and policymakers should be involved at this stage. It is advisable to base the choice of topic on the following criteria: clinical uncertainty (as evidenced by a significant variation in procedures between health care professionals), disease burden, possible health gains, incidence and/or prevalence of the condition or complaint, availability of medical research data, costs, patient safety, feasibility and implementation aspects. The following matrix can serve as a tool for weighing the various topic options. When revising a guideline, existing gaps in that guideline should be addressed.

Figure 2: selection of topic for guidelines

The final selection of a topic is not always a matter of choice, but is often partly motivated by external factors, such as agreements with other organisations (often involving cooperation on specific topics) or grants earmarked for developing guidelines that tie in with national priorities set by the government. This step-by-step plan must also be followed to prevent developing guidelines that do not meet the needs of the field.

4.2 Step 2: Mapping the topic

If no guidelines are available for the chosen topic, it is recommended to do some brief desk research on a number of important aspects such as prevalence, incidence and costs. To gain insight into knowledge currently available on the topic, existing regional work arrangements and protocols on the topic must be studied in addition to the existing national and international guidelines. It is also advisable to collect guidelines from related disciplines to foster cooperation and coordination. For reasons of efficiency, existing guidelines should be consulted first, such as those collected by the various knowledge centres (see Tool for electronic disclosure of guidelines). By going through existing material, a guideline development group can locate underlying inconsistencies and gaps in existing documentation. At the same time, they learn who has published what on the topic and who could therefore be involved in inventorying, analysing and selecting clinical care gaps or be involved in later stages once the guideline development process has begun. A guideline development group can also identify preliminary information on the topic together with experts. If possible, the development group will determine the scope of the topic. They can choose between prevention, diagnostics, treatment and/or aftercare relating to a complaint or condition. In addition, and if possible, they may also determine the patient group (for example whether to develop a guideline for depression in adults and whether to include postnatal depression, elderly people or children in these guidelines).

If a guideline is to be revised, the development group should determine which parts to revise by asking the following questions:

  • What does the new evidence apply to?
  • For which clinical care gaps experienced in daily practice do the existing guidelines offer no solution?
  • In which areas of professional practice do other methods appear to be used?
  • In which areas should new cooperation agreements be made?

5. Phase 2: Selecting the clinical care gaps that require a solution

5.1 Step 3: Identifying the clinical care gaps

The development group will identify and list the problems experienced in daily practice by care providers. Any revisions must explicitly address guideline commentary gathered from the field. Several options are available in terms of both the extent and the methodology for identifying clinical care gaps. The scope of the identification of clinical care gaps depends on the topic, professional groups and available funding. In general, it is recommended that an inventory of clinical care gaps is as simple as possible and as comprehensive as needed. In more concrete terms: a simpler inventory will suffice for topics on which there is much consensus, while a more extensive inventory will be needed for much debated topics or for topics on which there are conflicting views in order to take all views into account.

If an extensive inventory of clinical care gaps is required, it should be ‘tailored’. It is also important to critically consider who needs to be involved. This could include professionals from the field, patient and client organisations, associations of family members and other relevant parties, professionals from related fields, policymakers, health insurers, government, inspectorates, owners of existing guideline, scientists and implementing organisations. Due to local differences in health care services and organisation, it is desirable that those who are involved represent a diverse cross-section of the regional work field. Identifying clinical care gaps with patients often results in clinical care gaps related to the quality of all aspects of quality of care: relational, organisational and professional. It is also important to always document the motivation behind the clinical care gap in question so that at a later stage in the guideline development process an assessment can be made of whether the recommendations in the final guideline answer the clinical care gaps identified at the start. It is advisable to enquire about motivation, domain discussions and interests in order to detect obstacles to efficient health care cooperation, coordination and innovation.

Different methods can be used to compile an inventory of clinical care gaps. The following is a list of the possible methods (can also be applied in different combinations):

  • Structured brainstorming session with a pre-assembled focus group;
  • Invitational conference
  • Literature research;
  • Analysis of routinely collected data (records);
  • Individual interviews with care providers and/or patients;
  • Group interviews or focus group with care providers and/or patients;
  • Written surveys among care providers and/or patients;
  • Telephone surveys among care providers and/or patients;
  • Digital discussion forums with care providers and/or patients;
  • Web-based inventory.

The choice between the different methods (or combinations thereof) depends on the desired extent of the inventory of clinical care gaps (breadth of topic; number of professional groups that the topic concerns; perceived need for creating support) and the available resources (in time and money). It is advisable to conduct an exhaustive inventory of clinical care gaps until saturation is achieved or, in other words, until new efforts produce no new clinical care gaps. Please refer to the reference list for practical recommendations regarding the various methodologies for identifying clinical care gaps.

5.2 Step 4: Analysis of clinical care gaps

The purpose of the analysis is to conscientiously weigh the clinical care gaps, so that, in the next step, priorities can be made that do justice to the interests of all parties involved. It is advisable to classify/group clinical care gaps according to themes, for instance, based on previously identified literature. This could relate to prevention, diagnostics, treatment, organisation of care, etc. Dividing the clinical care gaps into themes will differ for each guideline development process. It is also advisable to verify whether the various clinical care gaps apply to the entire population or only to specific target groups.

5.3 Step 5: Selection of important clinical care gaps

If the result of the analysis of clinical care gaps consists of a large and heterogeneous list of clinical care gaps, a selection will first need to be made based on prioritisation in order to reach a workable plan. The majority of those involved in this step will be professionals from the field and patients and/or patient representatives. However, to include as many criteria/aspects as possible, other parties which were involved in compiling the inventory of clinical care gaps should also be involved in prioritising. The various parties may apply different crucial criteria when prioritising:

  • Professionals and patients from the field: extent to which the clinical care gap represents a problem in practice/urgency;
  • Professionals from related fields: aspects concerning both delimitation and cooperation in health care;
  • Owners of existing guideline: gaps and inconsistency in the knowledge;
  • Researchers: theoretical frameworks, available evidence and publication opportunities;
  • Policymakers/health insurers/government: feasibility, practicality, costs and urgency.

All parties involved should receive the results of the analysis of clinical care gaps with a request to select a top three (or five or ten) clinical care gaps that they feel have the highest priority. These parties should also indicate whether they have specific affinity with or interests related to the topic in question. It is important that the prioritisation process is done separately for each discipline, so that it is not the majority of votes alone that determines which clinical care gaps are prioritised. This can be done by use of a written or digital questionnaire or during a face-to-face meeting. Prioritising during face-to-face meetings (e.g. invitational conference) in which all relevant parties are represented has the advantage that mutual discussion can, in addition to scoring, contribute to making a good selection of clinical care gaps.

A thorough selection of clinical care gaps means that the guideline development group will be able to limit itself to answering only the most important clinical care gaps found in practice and will consequently be able to narrow the topic scope.

6. Phase 3: Addressing the clinical care gaps

6.1 Step 6: Choice of method for addressing/solving selected clinical care gaps

After selecting the clinical care gaps with the highest priority for further development, an assessment must be made whether a guideline is the most appropriate form to provide advice and recommendations on that topic. When the clinical care gap concerns lack of basic knowledge or skills, for example, training may be more appropriate than guideline development. When the clinical care gaps are strongly related to the health care system or structure, it may be better to formulate and promote a viewpoint or advice. And when sufficient evidence is available, but an overview of the available evidence is lacking, guideline development may be most appropriate.

This assessment process may lead to the following decisions:

  • To address the prioritised clinical care gaps by developing a new guideline. In this case, the development group should translate the clinical care gaps into review questions;
  • To address the prioritised clinical care gaps by modifying, revising or eliminating the existing guideline. The clinical care gaps should be translated into review questions;
  • To address the prioritised clinical care gaps by choosing a method other than guideline development.

The above steps should be followed to determine whether guideline development is the right method/tool for addressing the clinical care gaps. These steps should be taken as part of an independent process that occurs before any planned guideline project. Also, separate funding (5-15% of the total budget) should be made available for this. It is essential that professionals and patients from the field are involved as key participants in these preparatory steps. Professionals, policy makers, quality officers and guideline developers should decide together which method is most appropriate for addressing the selected clinical care gaps. If a decision is made to address the clinical care gaps through developing a guideline, the next step is for the guideline developers to translate the clinical care gaps into clearly defined and answerable review questions. If a guideline appears to offer the best solution for the prioritised clinical care gaps, the number of (evidence-based) review questions will depend on the available time and resources. The budget invested will be well-spent even if a decision is made to address the clinical care gaps in some other way rather than through guideline development: this other method may well lead to recommendations for training courses and viewpoints for organisations and governments.

7. Information transfer to guideline development group

If a decision is made to develop a guideline or revise an existing guideline, information on the following points from the preliminary research should be transferred to the guideline development group (in writing):

  • parties participating in the analysis of clinical care gaps and which clinical care gap was proposed by which party/parties;
  • existing information regarding the facilitating and obstructing factors related to the implementation of the future guideline (e.g. consideration for organisation/logistics and costs);
  • potential problems in the future development/revision of the guideline concerning conflicting ideas or interests of the different parties.

8. Literature

  • Evidence-based richtlijnontwikkeling (EBRO). Handleiding voor werkgroepleden (hoofdstuk 4: knelpuntenanalyse en opstellen van uitgangsvragen). Utrecht: CBO 2007 (www.cbo.nl/thema/Richtlijnen/EBRO-handleiding/4-Knelpunten-uitgangsvragen/).
  • The NICE Guidelines Manual 2009 (hoofdstuk 2: the scope). The UK National Institute for Health and Clinical Excellence (NICE) (www.nice.org.uk/GuidelinesManual).
  • Van Everdingen JJE, Burgers JS, Assendelft. WJJ, ea. Evidence-based richtlijnontwikkeling. Leidraad voor de praktijk. Houten: BSL, 2004.
  • Knelpunten, behoeften en wensen voor het ontwikkelen en implementeren van richtlijnen – Veldraadpleging in de cure, de care en de preventie. Den Haag: regieraad 2009 (www.regieraad.nl/downloads (pdf)).
  • Levende richtlijnen / actueel houden van richtlijnen. Den Haag: regieraad 2010 (www.regieraad.nl/downloads (pdf)).
  • SIGN 50: a guideline developer's handbook (hoofdstuk 3: selection of guideline topics). Revised edition 2008. Edinburgh, Scottish Intercollegiate Guidelines (pdf).
  • Jeanine Evers (red.) Kwalitatief interviewen: kunst en kunde. Den Haag: Lemma/Boom, 2007.
  • Kraaijeveld, K. & Weusten, S. ‘Helder denken, routeplanner voor je brein’. Kosmos Uitgevers B.V. 2010.