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KCE ProcessBook

Welcome!

This repository provides access to the KCE Process Notes and recommended research methods developed or acknowledged by KCE. 

You can open or download the documents directly or click on the title to view a summary, the full reference (most with .RIS to download) and the table of contents.

 This site is currently under reconstruction.

To conduct systematic reviews, KCE refers to the Cochrane Handbook for Systematic Reviews of Interventions:
  • it describes in detail the process of preparing and maintaining Cochrane systematic reviews on the effects of healthcare interventions
  • it includes guidance on the standard methods applicable to every review (planning a review, searching and selecting studies, data collection, risk of bias assessment, statistical analysis, GRADE and interpreting results), as well as more specialised topics (non-randomized studies, adverse effects, complex interventions, equity, economics, patient-reported outcomes, individual patient data, prospective meta-analysis, and qualitative research).
However, the protocol will be tailored for each project at the protocol meeting (see Project Guide).

Table of contents

Tools

Critical appraisal of the evidence:
  • GRADE book: to assess the certainty of evidence 
Critical appraisal of practice guidelines: 
  • AGREE II: to assess the methodological rigour and transparency in which a practice guideline is developed
  • AGREE Reporting Checklist: intended to assist practice guideline developers to improve the completeness and transparency of reporting in practice guidelines
Critical appraisal of systematic reviews: 
  • AMSTAR checklist: to assess the methodological quality of a review
  • ROBIS tool: to assess the level of bias present within a systematic review
  • ROB-ME tool: to assess the Risk Of Bias due to Missing Evidence
Critical appraisal of RCTs for interventions:
  • RoB 2 tool: to assess risk of bias in randomized trials
  • ROBUST-RCT tool (Risk Of Bias in Understanding the Strength of Trials—Randomised Controlled Trials): tool intended to address some of the practical limitations encountered with RoB 2 
Critical appraisal of diagnostic accuracy studies:
  • QUADAS-2 tool: instrument to assess the risk of bias and applicability of primary test accuracy studies for diagnosis, screening or staging disease (NB: This has now been superseded by the QUADAS-3 tool)
  • QUADAS-C: extension to QUADAS for assessing risk of bias in comparative accuracy studies
  • QUAPAS: extension of the QUADAS-2 tool to assess risk of bias in systematic reviews of prognostic test accuracy studies
Critical appraisal of observational studies:
  • ROBINS-I: preferred instrument for non-randomized studies of interventions
  • ROBINS-E tool: extends the ROBINS framework to observational epidemiological studies (cohort studies) that examine the effects of non-manipulable exposures
  • JBI Critical Appraisal tools: assist in assessing the trustworthiness, relevance and results of published papers

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NB: to see the list of tools for critical appraisal, please click on the title above


KCE Reports 411C (2026)

Summary


How to cite this document?

Jespers Vicky, Verleye Leen, Costa Elena, Vlayen Joan, Struyf Thomas. KCE Process Note: Research Methods for guidelines – update 2025. Methods. Brussels. Belgian Health Care Knowledge Centre (KCE). 2026. KCE Reports 411. (DOI: 10.57598/R411C)

Table of Contents

  1. Introduction
  2. general aspects of guideline developments
  3. Defining the scope and developing review questions
  4. Critical appraisal of the literature
  5. GRADE for interventions
  6. GRADE for diagnostic tests and test-treatment management strategies
  7. Recommendations
  8. Review and validation
  9. Dissemination
  10. Manual KCE - Validated assessment tools

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KCE Process Note (2016)

Summary


How to cite this document?

Mistiaen P, Leroy R, Van de Voorde C, Stordeur S, Van den Heede K. HSR Process Notes: Literature review and
international comparison. Methods. Brussels: Belgian Health Care Knowledge Centre (KCE). 2016.

Table of contents

  1. Introduction
  2. Literature review
  3. International comparison

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Summary

A literature review of economic evaluations can have three different objectives at KCE:
  1. To get a(n) (rough) idea of the cost-effectiveness of an intervention
  2. To identify variables and parameters to include in a to-be-developed Belgian economic evaluation
  3. To identify variables that need to be measured in the context of a KCE Trial to allow for a subsequent economic evaluation
The current guidance relates to the first objective only.

Tools

Three tools can support the researcher in its review. 
  1. A literature search strategy: A template has been created for all cost and cost-effectiveness related searches in different databases. It can be found here.
  2. A checklist for assessment of the quality of published economic evaluations : A reporting checklist can be used to assess whether all relevant information related to an economic evaluation has been reported.
    Appendix 3 of the Belgian Guidelines for Economic Evaluations and Budget Impact Analyses: Third Edition provides a checklist that can be used. The checklists do not have to be reported in the final KCE report but should be considered as a supporting tool for the reviewer. 
  3. A data extraction sheet: A data extraction sheet is a working document that can be used when extracting relevant information from published economic evaluations. This is a working document that can be used to prepare overview tables for e.g. the input used in these economic evaluations. It can support the critical assessment of existing literature.
    An example of a data extraction sheet is given in Appendix 4 of the Belgian Guidelines for Economic Evaluations and Budget Impact Analyses: Third Edition.

Files

  • Template for all cost and cost-effectiveness related literature searches in different databases (XLSX, KB)
  • Checklist for assessment of the quality of published economic evaluations, in Neyt Mattias, Thiry Nancy, Cleemput Irina. Belgian guidelines for economic evaluations and budget impact analyses: third edition. Methods. Brussels. Belgian Health Care Knowledge Centre (KCE). 2025. KCE Reports 400C. Appendix 3; p. 88-89. (PDF, 149 p., 2,21 MB)
  • Data extraction sheet, in Neyt Mattias, Thiry Nancy, Cleemput Irina. Belgian guidelines for economic evaluations and budget impact analyses: third edition. Methods. Brussels. Belgian Health Care Knowledge Centre (KCE). 2025. KCE Reports 400C. Appendix 4; p. 90 (PDF, 149 p., 2,21 MB)

KCE Reports 400C (2025)

Summary

In Belgium, cost-effectiveness is one of the criteria used by public authorities to assess applications for reimbursement of medicines and Class 1 medical devices, i.e. products for which the applicant claims added therapeutic value and for which a higher price may be charged. For other interventions as well (surgical procedures, vaccines, disease prevention strategies, screening programmes, etc.), economic evaluations and budget impact analyses provide valuable support for the efficient use of limited resources. This guideline is the result of the second update of the KCE guideline on economic evaluations in health and budget impact analyses. The aim is to improve the relevance, methodological quality, transparency and consistency of these economic evaluations of health interventions in Belgium.

How to refer to this document?

Neyt Mattias, Thiry Nancy, Cleemput Irina. Belgian guidelines for economic evaluations and budget impact analyses: third edition. Methods. Brussels. Belgian Health Care Knowledge Centre (KCE). 2025. KCE Reports 400C. DOI: 10.57598/R400C.

Table of contents

  1. Background
  2. Objectives
  3. Methods
  4. Brief overview of the Belgian guidelines and general remarks
  5. Guidelines for health economics evaluation
  6. Guidelines for budget impact analyses
  7. Discussion

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KCE Reports 342C (2021)

Summary

For a long time, decisions on whether to reimburse a health intervention have taken into account the impact of the illness and its treatment on patient life expectancy and quality of life. For life expectancy, there is a clear measure: time. However, quality of life is harder to quantify. Yet it is essential to know how to measure it in order to be able to make comparisons between patients suffering from different conditions and/or receiving different treatments.

EQ-5D is a tool that is widely used for measuring health-related quality of life (in other words, the specific impact of health or illness on quality of life). Its EQ-5D-5L version describes 3,125 states of health to which a “value” is attributed reflecting quality of life, called the “utility score”. For the first time, KCE has developed a set of values (valuation matrix) for EQ-5D-5L, based on an extensive survey among a representative sample of the Belgian population.

This valuation matrix proposes, for each health issue described by EQ-5D, a quality of life value reflecting the average preferences of the Belgian population.

When it comes to assessing health interventions, treatments or new technologies, these utility scores make it possible to choose between length of life and quality of life. 

The study was cofunded by EuroQol Research Foundation.

How to refer to this document?

Bouckaert Nicolas, Gerkens Sophie, Devriese Stephan, Cleemput Irina. An EQ-5D-5L value set for Belgium – How to value health-related quality of life? Health Services Research (HSR). Brussels. Belgian Health Care Knowledge Centre (KCE). 2021. KCE Reports 342. DOI: 10.57598/R342C. 

Table of contents

  1. Introduction
  2. Methods
  3. Data analysis
  4. Results: the Belgian EQ-5D-5L value set
  5. Discussion and conclusion

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KCE Reports 408C (2025)

Summary

In the context of KCE research, qualitative methods can provide a deeper, more concrete understanding of the topic under investigation than purely quantitative data, as well as valuable insights regarding its wider context. Their aim is not just to describe, but also to obtain more meaningful explanations of a phenomenon. They can also be useful in generating hypotheses. Qualitative research methods are particularly valuable in research on the organisation of healthcare (known as Health Services Research or HSR), but they can also be used in other types of projects like Health Technology Assessments (HTA) or the development of Good Clinical Practice guidelines (GCP).

How to cite this document?

Dauvrin Marie, Kohn Laurence, Christiaens Wens, Benahmed Nadia, Cornelis Justien, Desomer Anja, Paradis Julie, Cleemput Irina. KCE Process Note: Qualitative Research Methods. Methods. Brussels. Belgian Health Care Knowledge Centre (KCE). 2025. KCE Reports 408C. DOI: 10.57598/R408C. 

Table of contents

  1. Why this report?
  2. Aims
  3. Methodology
    PART 1
  4. What are the specificities of qualitative research?
  5. Frequently asked questions about qualitative research studies
  6. Preparing a qualitative research study 
  7. Ethical issues specific to qualitative health research
  8. Quality and validity of qualitative research methods
  9. Reflexivity in qualitative health research
    PART 2

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KCE Reports 410C (2025)

Summary

In order to inform decision-makers' choices, KCE is increasingly being asked to consider different possible developments in the field of healthcare. The uncertainties associated with these developments can be analysed using the scenario approach, i.e. coherent descriptions of plausible futures and the path(s) leading to these futures. In this context, KCE has developed a step-by-step guide providing practical advice on the use of the scenario approach in KCE studies.

Scenarios, as understood here, are narrative descriptions of different plausible and coherent futures that depend on the (still uncertain) evolution of external factors beyond the direct control of stakeholders. The approach described in this report is a deductive and participatory method. It is based on three key steps:

  • In the first phase (scoping), the focus question is defined and the stakeholders to be involved are identified.
  • The second phase (scanning) consists of systematically gathering information to identify factors that may influence future developments, assess their potential impact on the subject under study, and evaluate the degree of uncertainty surrounding their occurrence.
  • During the third phase (scenario building), the scenarios themselves are constructed on the basis of a conceptual framework and the narratives are written.

This guide is intended to be practical and non-exhaustive. It also includes numerous examples to facilitate understanding of the concepts.

How to refer to this document?

Lefèvre Mélanie, Benahmed Nadia, Christiaens Wens. Using the scenario approach in KCE studies. Methods. Brussels. Belgian Health Care Knowledge Centre (KCE). 2025. KCE Reports 410. DOI: 10.57598/R410C.

Table of contents

1 INTRODUCTION 
   1.1 THE SCENARIO APPROACH
   1.2 AIM OF THE REPORT
   1.3 METHODS 
2 THEORETICAL BACKGROUND 
   2.1 DEFINITION OF THE SCENARIO APPROACH 
   2.2 THREE-STEP APPROACH 
   2.3 SCOPING 
      2.3.1 Stakeholder involvement 
      2.3.2 Focal question 
   2.4 SCANNING 
      2.4.1 Identification 
      2.4.2 Grouping and selecting drivers
      2.4.3 Documenting 
   2.5 SCENARIO BUILDING 
      2.5.1 2x2 matrix 
      2.5.2 Morphological analysis 
3 LEARNING FROM PAST KCE EXPERIENCES 
4 A PRACTICAL GUIDE TO USE THE SCENARIO APPROACH IN A KCE STUDY 
   4.1 WHEN TO USE THE SCENARIO APPROACH? 
   4.2 STEP BY STEP GUIDE AND PRACTICAL TIPS 
APPENDIX 1. IDENTIFICATION OF PREVIOUS KCE REPORTS USING THE APPROACH
APPENDIX 2. EXAMPLE OF NARRATIVE SCENARIO 
   APPENDIX 2.1. SCÉNARIO CENTRÉ SUR L’HÔPITAL DANS LEQUEL LES SAGES-FEMMES OCCUPENT UNE PLACE CENTRALE
   APPENDIX 2.2. SCENARIO WAARBIJ HET ZIEKENHUIS CENTRAAL STAAT EN WAARBIJ VROEDVROUWEN EEN CENTRALE PLAATS INNEMEN 

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KCE Reports 340 (2021)

Summary

This process note aims at providing guidance on how to involve patients at various stages of a research process. It follows the publication of the Position Paper on Patient Involvement in KCE research in 2019 (KCE Report 320). The process note describes potential barriers and proposes practical solutions to help researchers to actively involve patients in their research projects.

This process note is accompanied by a practical guide of animation techniques that may help to involve patients in a practical, effective and pleasant way. These techniques could also be used with other target groups. 

Both of these publications are living documents: they will be updated based on the future experiences of KCE researchers when involving patients.  

How to cite this document?

Kohn Laurence, Dauvrin Marie, Cleemput Irina. Patient involvement in policy research at KCE: process note. Methods. Brussels. Health Care Knowledge Centre (KCE). 2021. KCE Reports 340. DOI: 10.57598/R340C. 

Table of Contents

  1. Introduction
  2. Methods
  3. Process note on "Patient involvement"

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KCE Reports 386C (2024)

Summary

Classic KCE reports are often time- and resource-consuming, but in a rapidly changing healthcare environment, there is sometimes a need for faster assessments of available evidence. To provide faster scientific answers to pressing healthcare questions, the KCE has developed a new ‘accelerated’ methodology.

How to refer to this document?

Roberfroid Dominique, Castanares-Zapatero Diego, Chalon Patrice, Costa Elena, Dauvrin Marie, de Meester Christophe, Desomer Anja, Fairon Nicolas, Hourlay Luc, Jonckheer Pascale, Kohn Laurence, Lefèvre Mélanie, Levy Muriel, Ombelet Sien, San Miguel Lorena, Schönborn Claudia, Van de Voorde Carine, Van den Heede Koen. Expedited Scientific Research and Reporting (ESRO) at KCE. Methods. Brussels. Belgian Health Care Knowledge Centre (KCE). 2024. KCE Reports 386C. DOI: 10.57598/R386C. 

Table of contents

  1. Rationale
  2. Objectives and methods
  3. General ESRO framework at KCE
  4. Expedited literature reviews
  5. Expedited international comparisons
  6. Rapid qualitative research
  7. Automation

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Process note Web survey (2015)

Summary

This process note aims to guide you in the building of an online survey. Examples of texts are given taken from already carried out surveys and part of the manual edited on this process note explains the basics to create and manage an online survey.

How to refer to this document?

Kohn Laurence, Devos Carl. Process Note: Websurvey@kce. Methods. Brussels. Belgian Health Care Knowledge Centre (KCE). 2015.

Table of contents

  1. Background
  2. Process
  3. How to prepare a survey?
  4. Sampling
  5. Recruitment of the participants
  6. Questionnaire building
  7. Put the questionnaire online
  8. Pilot the online survey
  9. Test-retest (optional)
  10. Launch the final survey
  11. Send reminders
  12. Close the survey
  13. Insert data manually
  14. Analysis and reporting

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Appendices

Guidance (2026)

Summary

The integration of Artificial Intelligence (AI), into workflows at the Belgian Health Care Knowledge Centre (KCE) presents both opportunities and risks. This guidance aims to support KCE staff, collaborators, and contractors in using AI tools responsibly and securely.

Key points

Responsible use of Artificial Intelligence at KCE is based on the following principles:
• Complete human oversight: AI can assist but not replace your judgment. You must review and take full responsibility for any AI-generated output before using or sharing it.
• Confidentiality: Always protect sensitive information. Use only AI tools with strong data protection (e.g. Microsoft Copilot 365 with KCE license), and never share personal data with any external AI tool.
• Transparency: If AI is used in a substantial and intentional way, disclose it clearly in reports, publications, and presentations, following the provided guidance.
• Proportionality & Environmental Awareness: Use AI only when it adds real value. Avoid using it for trivial tasks, design prompts carefully, and consider the environmental impact of each query.
• Legality: AI use should comply at all times with applicable European and Belgian law, in particular the EU Artificial Intelligence Act, the General Data Protection Regulation, copyright and intellectual property legislation and, where relevant, sector-specific healthcare regulations

How to cite this document?

Costa E, Bourgeois J, Camberlin C, Chalon P, de Meester C, Devriese S, D’Hollander K, Fairon N, Hourlay L, Van Deynse H, Vinck I. Responsible use of AI at KCE: a guidance. Brussels: Belgian Health Care Knowledge Centre (KCE). 2026.

Table of Contents

  1. Introduction
  2. Methods
  3. Guidance
    • Complete human oversight
    • Confidentiality
    • Transparency
    • Proportionality and environmental awareness
  4. Reviews and updates
  5. References

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