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Développement académique de médicaments de thérapie innovante (ATMP) en Belgique : considérations juridiques et stratégiques – Synthèse
No full text37 p.ill.,Les médicaments de thérapie avancée (ATMP, Advanced Therapy Medicinal Products) sont des thérapies complexes basées sur des cellules, des gènes ou des tissus. À l’heure actuelle, ils sont surtout développés et utilisés pour le traitement de certaines formes de cancer ou de maladies génétiques. Les ATMP actuellement commercialisés par l’industrie sont peu nombreux et souvent proposés à un coût élevé, pouvant atteindre plusieurs millions d’euros par traitement. À la demande de plusieurs associations belges de lutte contre le cancer, le Centre Fédéral d’Expertise des Soins de Santé (KCE) a examiné comment optimiser le rôle des universités belges dans ce domaine, dans le but d’améliorer l’accès à ces médicaments pour les patients. Pour atteindre cet objectif, il sera indispensable que les acteurs académiques et les autorités disposent d’une expertise de pointe et collaborent de façon plus étroite. Par ailleurs, sachant que le développement de tels produits peut s’étendre sur de nombreuses années, il faut que le financement couvre une période suffisamment longue et soit moins fragmenté.PRÉFACE 1 -- MESSAGES CLÉS 2 -- SYNTHÈSE 3 -- LISTE DES ABRÉVIATIONS 7 -- 1. INTRODUCTION 8 -- 1.1. QU’EST-CE QU’UN ATMP ? 8 -- 1.2. LE RÔLE MAJEUR DU MONDE ACADÉMIQUE 8 -- 2. OBJECTIF, PORTÉE ET MÉTHODOLOGIE 10 -- 2.1. OBJECTIF ET PORTÉE 10 -- 2.2. QU’AVONS-NOUS ÉTUDIÉ ? 10 -- 2.3. COMMENT AVONS-NOUS PROCÉDÉ ? 11 -- 3. CADRE JURIDIQUE RELATIF AUX ATMP 11 -- 3.1. UN CADRE JURIDIQUE SPÉCIFIQUE 11 -- 3.2. ET COMPLEXE 12 -- 3.2.1. Une limite floue avec la réglementation concernant le sang, les tissus et les cellules (BTC) 12 -- 3.2.2. Une compétence qui incombe également aux États membres 12 -- 3.3. RÉVISION FUTURE DE LA LÉGISLATION EUROPÉENNE SUR LES MÉDICAMENTS ET ENTRÉE EN VIGUEUR DU RÈGLEMENT EUROPÉEN HTA 12 -- 4. FILIÈRES D’ACCÈS POSSIBLES POUR L’ACCÈS AUX ATMP 13 -- 4.1. ACCÈS VIA LA PARTICIPATION À DES ESSAIS CLINIQUES 14 -- 4.1.1. Les études cliniques avec des ATMP, un défi particulier pour les acteurs académiques 14 -- 4.1.2. Les essais cliniques académiques ne visent souvent pas l’autorisation de mise sur le marché 14 -- 4.2. ACCÈS PAR LE BIAIS D’UNE AMM 14 -- 4.2.1. Obtenir une AMM, un défi encore plus grand pour les acteurs académiques 14 -- 4.2.2. Limites de l’AMM en tant que voie d’accès aux ATMP 15 -- 4.3. ACCÈS VIA L’EXEMPTION HOSPITALIÈRE 16 -- 4.3.1. Qu’est-ce qu’une exemption hospitalière ? 16 -- 4.3.2. L’utilisation de l’exemption hospitalière en Europe est difficile à estimer 17 -- 4.3.3. Adaptations possibles de la législation pharmaceutique de l’UE 17 -- 5. L’ACCÈS AUX ATMP EN BELGIQUE 18 -- 5.1. PAR LE BIAIS D’UNE AUTORISATION DE MISE SUR LE MARCHÉ (AMM) CENTRALISÉE ET D’UN REMBOURSEMENT 18 -- 5.1.1. Une AMM n’est pas toujours synonyme d’accès en Belgique 18 -- 5.1.2. Remboursement par le biais de contrats confidentiels uniquement 18 -- 5.1.4. Fonds spécial de solidarité 19 -- 5.2. PAR LE BIAIS D’ESSAIS CLINIQUES 19 -- 5.3. PAR LE BIAIS D’UNE EXEMPTION HOSPITALIÈRE 19 -- 5.3.1. Conditions d’octroi d’une exemption hospitalière en Belgique 19 -- 5.3.2. Quand l’EH est-elle refusée en Belgique ? 20 -- 5.3.3. Une seule EH octroyée 20 -- 5.3.4. Remboursement des ATMP dans le cadre de l’EH 20 -- 6. ENSEIGNEMENTS DE TROIS PROJETS DE DÉVELOPPEMENT ACADÉMIQUE EN COURS 21 -- 6.1. INTRODUCTION 21 -- 6.2. THÉRAPIE CELLULAIRE PAR LYMPHOCYTES D’INFILTRATION TUMORALE (TIL) – PAYS-BAS 21 -- 6.2.1. Qu’est-ce que la thérapie par lymphocytes d’infiltration tumorale ? 21 -- 6.2.2. Exemption hospitalière après des résultats d’étude favorables 22 -- 6.2.3. Création d’une entité à but non lucratif pour l’enregistrement et l’AMM 22 -- 6.3. THÉRAPIE CAR-T ARI-0001 – ESPAGNE 22 -- 6.3.1. Que sont les CAR-T 22 -- 6.3.2. Exemption hospitalière après des résultats d’étude favorables 23 -- 6.3.3. Soutien de l’EMA et développement ultérieur 23 -- 6.4. THÉRAPIE GÉNIQUE STRIMVELIS – ITALIE 24 -- 6.5. LEÇONS UTILES 24 -- 6.5.1. La présence d’un besoin médical 24 -- 6.5.2. Expertise académique 24 -- 6.5.3. Financement et soutien 25 -- 6.5.4. L’exemption hospitalière en tant que voie d’accès 25 -- 6.5.5. Une entité distincte comme titulaire de l’AMM 25 -- 7. DÉFIS POUR LE DÉVELOPPEMENT D’ATMP PAR LES ACTEURS ACADÉMIQUES EN BELGIQUE 25 -- 7.1. INTRODUCTION 25 -- 7.2. DIFFÉRENTES INTERPRÉTATIONS DE L’EXEMPTION HOSPITALIÈRE 25 -- 7.3. ABSENCE D’UN PLAN GLOBAL AXÉ SUR LES BESOINS ET FINANCEMENT FRAGMENTÉ 26 -- 7.4. BESOIN D’UNE PLUS GRANDE EXPERTISE TRANSLATIONNELLE AU NIVEAU DES POUVOIRS PUBLICS ET DES ACTEURS ACADÉMIQUES 27 -- 7.5. DÉFIS D’UNE PRODUCTION CONFORME AUX BPF 27 -- 7.5.1. Des installations coûteuses 27 -- 7.5.2. Défis et opportunités de la production décentralisée d’ATMP dans les centres académiques 28 -- 8. COMMENT PROMOUVOIR LE DÉVELOPPEMENT ACADÉMIQUES D’ATMP EN BELGIQUE ? 29 -- 8.1. SOUTIEN FINANCIER DES AUTORITÉS 29 -- 8.1.1. Analyse des aides d’État 29 -- 8.1.2. Octroi de licences socialement responsables et stratégies en matière de propriété intellectuelle 31 -- 8.2. AMÉLIORER LE PARCOURS D’EXEMPTION HOSPITALIÈRE 32 -- 8.3. DIALOGUE ET ÉCHANGE DE CONNAISSANCES 32 -- 8.3.1. Avec le soutien des pouvoirs publics 32 -- 8.3.2. Entre acteurs académiques 32 -- 9. CONCLUSION 33 -- RECOMMANDATIONS 3
Speech/ language therapy for children with neurodevelopmental disorders
No full text164 p.Ill.,SCIENTIFIC REPORT 8 -- 1 INTRODUCTION 8 -- 1.1 CONTEXT OF THIS REPORT 8 -- 1.1.1 Background 8 -- 1.1.2 Governance and organisation of health care, rehabilitation and education in Belgium: an outline in the context of this report 9 -- 1.1.3 History of reimbursement of monodisciplinary speech/language therapy in Belgium 15 -- 1.1.4 Current Request to KCE 20 -- 1.1.5 Definitions and scope of this research 20 -- 2 METHODS 29 -- 2.1 GENERAL APPROACH 29 -- 2.1.1 Development of Research Questions 29 -- 2.1.2 Development of research strategy and PICOS 30 -- 2.2 SEARCH FOR GUIDELINES 32 -- 2.3 SEARCH FOR SYSTEMATIC REVIEWS 34 -- 2.4 DATA EXTRACTION 36 -- 2.4.1 Data from guidelines 36 -- 2.4.2 Data from systematic reviews 45 -- 2.5 STAKEHOLDER CONSULTATION 46 -- 3 RESULTS GUIDELINES 47 -- 3.1 CHARACTERISTICS OF SELECTED GL 47 -- 3.1.1 Intellectual disability (ID) 47 -- 3.1.2 Autism spectrum disorder (ASD) 49 -- 3.1.3 Attention-deficit/hyperactivity disorder (ADHD) 51 -- 3.1.4 Communication disorders (CD) 51 -- 3.1.5 Specific learning disorder (LD) 51 -- 3.2 SUMMARY OF THE FINDINGS 52 -- 3.2.1 Intellectual disability (ID) 52 -- 3.2.2 Autism spectrum disorder (ASD) 79 -- 3.2.3 Attention-deficit/hyperactivity disorder (ADHD) 108 -- 3.2.4 Communication disorders (CD) 110 -- 3.2.5 Specific learning disorder (LD) 115 -- 4 RESULTS SYSTEMATIC REVIEWS 116 -- 4.1 CHARACTERISTICS OF INCLUDED STUDIES 116 -- 4.2 SUMMARY OF THE FINDINGS 117 -- 4.2.1 Systematic reviews with meta-analysis 117 -- 4.2.2 Systematic reviews with narrative synthesis 118 -- 5 NARRATIVE SYNTHESIS OF STAKEHOLDER VIEWS 131 -- 5.1 ASSESSMENT 131 -- 5.2 THERAPY 132 -- 5.3 SETTING 133 -- 5.4 ROLE OF EDUCATION 136 -- 5.5 PRACTITIONER 137 -- 5.6 AIMS 138 -- 5.7 CUMUL RULES AND THERAPY SETTINGS 139 -- 5.8 ADDITIONAL INFORMATION SHARED AFTER THE MEETINGS 140 -- 6 CONCLUSION AND DISCUSSION 142 -- 6.1 WHAT DID WE LEARN FROM THE LITERATURE? 143 -- 6.2 MAIN METHODOLOGICAL CONSIDERATIONS 145 -- 6.3 CONTEXTUAL CONSIDERATIONS: BELGIAN CONTEXT AND STAKEHOLDER VIEWS 147 -- 6.4 FROM EVIDENCE TO RECOMMENDATIONS 150 -- 6.4.1 Effectiveness of SLT in the target groups 150 -- 6.4.2 ID and ASD: SLT in the framework of multiprofessional treatment planning and therapy provision 152 -- 6.4.3 ID and ASD: monodisciplinary SLT 152 -- 6.4.4 Multidisciplinary diagnostic assessments 152 -- 6.4.5 Cumul rules: cumulation of treatment provision in different sectors 152 -- 6.4.6 Intermediate measures 153 -- 6.4.7 Accreditation and quality 154 -- 6.4.8 Education and training of professionals 154 -- 6.4.9 Early treatment 154 -- 6.4.10 Augmentative and alternative communication (AAC) 155 -- 6.4.11 Policy recommendations 155 -- REFERENCES 15
Need assessment framework 2025 : EU expert consensus and core version
No full text61 p.ill.,The goal of the NEED initiative is to assess patients’ and society’s unmet health-related needs in a scientific and structured way. This information, collected in a dedicated database, can then be used to inform innovation and healthcare policies to help them target the areas of highest need.
In 2024, the NEED research team developed a framework for assessing unmet needs for a given disease or health condition. Since then, it has been working tirelessly to refine the framework, taking on board the lessons learnt from two case studies and from an additional study on the applicability of the concept to rare diseases. It has also developed a methodology for the identification and selection of the health conditions to be assessed.
More recently, the framework was submitted to 26 experts from 17 EU member states in order to reach a consensus on its general structure and on its individual components (the criteria and indicators used to assess health-related needs). This is an important step to ensure the acceptability and relevance of the framework across diverse European contexts.
This new report presents the latest version of the framework following the European consensus and an internal team discussion. It also introduces a core version of the framework containing the minimally required criteria for a meaningful assessment of unmet health-related needs. This will hopefully speed up the process of filling up the NEED evidence database, as these core assessments, while still relevant to inform healthcare planning and decision-making, will require less time and resources.1 INTRODUCTION 3 -- 2 AIMS 4 -- 3 METHODS 5 -- 3.1 MODIFIED DELPHI STUDY 6 -- 3.1.1 Participants 6 -- 3.1.2 Data Collection 6 -- 3.2 INTERNAL DISCUSSIONS 7 -- 4 RESULTS 7 -- 4.1 INTERNATIONAL CONSENSUS ON THE NEED ASSESSMENT FRAMEWORK 8 -- 4.1.1 Participants 8 -- 4.1.2 Round 1 and 2 results 9 -- 4.1.3 Modifications to criteria and indicators through the Delphi process 15 -- 4.2 THE NEED ASSESSMENT FRAMEWORK 2025 15 -- 4.3 THE CORE NEED ASSESSMENT FRAMEWORK 16 -- 5 DISCUSSION 17 -- 6 CONCLUSION 1
Guideline for the diagnosis, treatment, and follow-up of cutaneous melanoma in secondary care : Supplement
No full text32 p.ill.,1 GENERAL ASPECTS OF A KCE GUIDELINE 4 -- 1.1 FUNDING AND DECLARATION OF INTEREST 4 -- 1.2 STATEMENT OF INTENT 4 -- 1.3 TARGET USERS OF A GUIDELINE 4 -- 1.4 STAKEHOLDERS, EXPERTS, PATIENT INVOLVEMENT 4 -- 1.4.1 The guideline development group 4 -- 1.4.2 Stakeholders 5 -- 1.4.3 Patient involvement 5 -- 2 METHODOLOGY 5 -- 2.1 SCOPING PHASE 5 -- 2.2 DEVELOPMENT OF RESEARCH QUESTIONS 6 -- 2.3 THE GRADE-ADOLOPMENT APPROACH 6 -- 2.4 EVIDENCE REVIEW 8 -- 2.4.1 Selection and quality assessment of systematic reviews 9 -- 2.4.2 Selection and quality assessment of primary studies 10 -- 2.4.1 Summarising the evidence 10 -- 2.4.2 The quality of evidence 10 -- 2.5 FROM EVIDENCE TO RECOMMENDATIONS 12 -- 2.6 GOOD PRACTICE STATEMENTS AND CLINICAL PRACTICE GUIDANCE 13 -- 2.7 EXTERNAL REVIEW AND VALIDATION 14 -- 2.7.1 Stakeholder review 14 -- 2.7.2 Validation by external experts 14 -- 2.7.3 Validation by the Belgian Centre for Evidence-Based Medicine 15 -- 2.8 DISSEMINATION AND IMPLEMENTATION 15 -- 3 VALIDATED ASSESSMENT TOOLS 16 -- 3.1 AGREE II – QUALITY GUIDELINES 16 -- 3.2 AMSTAR 2 – QUALITY SYSTEMATIC REVIEWS 17 -- 3.3 QUADAS-2 – RISK OF BIAS DIAGNOSTIC STUDIES 22 -- 3.4 ROB-1 – RISK OF BIAS FOR RCTS 25 -- 3.5 ROBINS-I – RISK OF BIAS IN NON-RANDOMISED STUDIES OF INTERVENTIONS 2
KCE Process Note: Qualitative Research Methods
No full text203 p.ill.,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).
The first KCE process note on qualitative research methods (QRM) was issued in 2012, as part of a collection of methodological guidance documents aiming to help in-house experts and subcontractors deliver high-quality research based on the best evidence available. It addressed the nature and usefulness of qualitative research and qualitative findings, but also the crucial issue of their quality and validity as evidence.
Thirteen years later, the importance of QRM in the field of health sciences in general and at KCE in particular has considerably increased, as has the underlying methodological basis. The world too has changed over the last decade, not least because of the profound impact of COVID-19 and the spectacular boost it gave to remote and online solutions. This evolution inevitably influenced qualitative research on a practical level, with remote or hybrid meetings or interviews becoming commonplace, but also, more fundamentally, with the increasing use of online data collection techniques. At KCE, COVID-19 also triggered an in-depth reflection on expedited research and reporting (ESRO), the qualitative component of which poses specific challenges.
For all these reasons, the time had come to revise, improve and develop the original process note to include recent evolutions and new experiences, and provide KCE researchers with up-to-date methodological guidance on qualitative research methods.
This new report aims to provide hands-on advice and criteria for the use of QRM in KCE studies, and to broaden the knowledge base about QRM within KCE. It contains some theoretical knowledge on QRM, advice for putting them in practice and (answers to) frequently asked questions to guide decision-making, as well as links to numerous more specific procedures, templates and other resources.INTRODUCTION 12 -- 1. WHY THIS REPORT? 12 -- 2. AIMS 13 -- 3. METHODOLOGY 13 -- 3.1 PREPARATORY WORK 13 -- 3.2 GENERAL DESIGN AND PROCESS 13 -- 3.3 HOW TO USE THIS REPORT 14 -- PART 1–TRANSVERSAL DIMENSIONS OF QUALITATIVE RESEARCH 16 -- 4. WHAT ARE THE SPECIFICITIES OF QUALITATIVE RESEARCH? 16 -- 4.1 KEY FEATURES OF QUALITATIVE RESEARCH 16 -- 4.2 THEORETICAL APPROACHES IN QUALITATIVE RESEARCH 17 -- 4.3 WHAT IS THE APPROACH TO QUALITATIVE RESEARCH AT KCE? 18 -- 5. FREQUENTLY ASKED QUESTIONS ABOUT QUALITATIVE RESEARCH STUDIES 19 -- 5.1 DOES THE STUDY REQUIRE A QUALITATIVE RESEARCH APPROACH? 19 -- 5.2 CAN A RAPID QUALITATIVE RESEARCH APPROACH BE APPLIED? 21 -- 5.3 DOES THE PROJECT REQUIRE PRIMARY QUALITATIVE DATA COLLECTION? 22 -- 5.4 CAN RELEVANT AND ROBUST PREEXISTING QUALITATIVE DATA BE USED IN A RESEARCH PROJECT? 22 -- 5.5 IS THE APPROVAL OF AN ETHICS COMMITTEE NECESSARY? 23 -- 5.6 IS STAKEHOLDER CONSULTATION A QUALITATIVE RESEARCH APPROACH? 23 -- 5.7 DOES PATIENT INVOLVEMENT REQUIRE QUALITATIVE RESEARCH METHODS? 24 -- 5.8 ARE EXPLORATORY INTERVIEWS AND SITE VISITS QUALITATIVE RESEARCH METHODS? 24 -- 5.9 IS ARTIFICIAL INTELLIGENCE OF INTEREST FOR QUALITATIVE RESEARCH METHODS? 25 -- 5.9.1 Added value of artificial intelligence for qualitative research methods 27 -- 5.9.2 Bias and other concerns related to artificial intelligence 28 -- 6. PREPARING A QUALITATIVE RESEARCH STUDY 29 -- 6.1 PLANNING A QUALITATIVE RESEARCH STUDY 29 -- 6.2 QUALITATIVE RESEARCH PROTOCOL 30 -- 6.3 CHOOSING AN A-PRIORI THEORETICAL FRAMEWORK 31 -- 7. ETHICAL ISSUES SPECIFIC TO QUALITATIVE HEALTH RESEARCH 32 -- 7.1 ETHICAL ISSUES RAISED BY QUALITATIVE RESEARCH 32 -- 7.2 HOW TO MANAGE ETHICAL ISSUES IN QUALITATIVE RESEARCH METHODS? 34 -- 7.2.1 Respecting ethical and deontological codes and guidelines 34 -- 7.2.2 Data protection and archiving 34 -- 7.2.3 Obtaining and proving informed consent 34 -- 7.2.4 Ensuring a voluntary consent and avoiding pressure to participate 35 -- 7.2.5 Avoiding adverse consequences for the participants 36 -- 7.2.6 Anticipating the need for disclosure of personal information of study participants 37 -- 7.2.7 Enabling participation 38 -- 7.2.8 Protecting researchers from adverse consequences 38 -- 7.3 IS THE APPROVAL OF AN ETHICS COMMITTEE NECESSARY? 39 -- 8. QUALITY AND VALIDITY OF QUALITATIVE RESEARCH METHODS 40 -- 8.1 BIAS IN QUALITATIVE RESEARCH METHODS 40 -- 8.2 GENERAL QUALITY CRITERIA 44 -- 8.2.1 Credibility and dependability: triangulation 44 -- 8.2.2 Transferability: thick description 45 -- 8.2.3 Dependability: researcher triangulation and audit 45 -- 8.2.4 Confirmability: audit and reflexivity 46 -- 8.3 APPRAISAL TOOLS AND CHECKLISTS 47 -- 8.3.1 Appraisal tools and checklists for qualitative syntheses and primary qualitative studies 47 -- 8.3.2 Appraisal tools for Delphi processes 47 -- 9. REFLEXIVITY IN QUALITATIVE HEALTH RESEARCH 48 -- 9.1 WHAT IS REFLEXIVITY? 48 -- 9.2 WORKING ON ONE'S REFLEXIVE POSTURE AS A RESEARCHER: WHAT DOES THIS IMPLY? 49 -- 9.3 HOW TO FEED THE REFLEXIVE POSTURE? 49 -- 9.4 WHICH TOOLS CAN BE USED TO ENHANCE REFLEXIVITY? 50 -- 9.5 WHEN TO THINK ABOUT REFLEXIVITY? 51 -- PART 2 – QUALITATIVE RESEARCH METHODS BASED ON EXISTING DATA 52 -- 10. LITERATURE REVIEWS OF QUALITATIVE EVIDENCE 52 -- 10.1 IS A SPECIFIC RESEARCH PROTOCOL NEEDED? 52 -- 10.2 WHY AND WHEN TO CONDUCT A LITERATURE REVIEW OF QUALITATIVE EVIDENCE? 53 -- 10.3 HOW TO CHOOSE BETWEEN A MAPPING, A SCOPING, OR A SYSTEMATIC LITERATURE REVIEW? 54 -- 10.4 IS A SPECIFIC SEARCH STRATEGY NEEDED FOR EXPLORING QUALITATIVE EVIDENCE IN LITERATURE? 57 -- 10.5 ARE THERE SPECIFIC DATABASES FOR QUALITATIVE RESEARCH? 58 -- 10.6 ARE THERE DATABASES INCLUDING FRENCH OR DUTCH LITERATURE? 61 -- 10.7 ARE THERE SPECIFIC FILTERS WHEN RETRIEVING QUALITATIVE EVIDENCE? 63 -- 10.8 HOW TO MANAGE DATA EXTRACTION? 63 -- 10.9 ARE THERE SPECIFIC METHODS FOR SYNTHESISING THE FINDINGS OF A QUALITATIVE LITERATURE REVIEW? 64 -- 10.10 CAN QUALITATIVE FINDINGS BE INTEGRATED IN AN EFFECTIVENESS REVIEW? 65 -- 11. USE OF OPEN DATA IN QUALITATIVE RESEARCH 65 -- 11.1 WHAT ARE OPEN QUALITATIVE DATA AND HOW TO FIND THEM? 65 -- 11.2 WHAT ARE THE STRENGTHS OF USING OPEN QUALITATIVE DATA, AND FOR WHAT PURPOSES? 66 -- 11.3 WHAT ARE THE WEAKNESSES OF USING OPEN QUALITATIVE DATA? 67 -- 11.4 HOW TO ACCESS OPEN QUALITATIVE DATA? 68 -- 11.5 HOW TO EVALUATE THE QUALITY OF OPEN QUALITATIVE DATA? 68 -- 11.6 HOW TO ANALYSE OPEN QUALITATIVE DATA? 72 -- 11.7 HOW TO REPORT OPEN QUALITATIVE DATA? 72 -- PART 3 - QUALITATIVE RESEARCH METHODS BASED ON PRIMARY DATA 73 -- 12. GENERAL PRINCIPLES OF PRIMARY DATA COLLECTION 73 -- 12.1 HOW TO PLAN THE PRIMARY DATA COLLECTION? 73 -- 12.2 HOW TO CHOOSE THE DATA COLLECTION TECHNIQUE? 75 -- 12.3 HOW TO DO THE SAMPLING? 81 -- 12.3.1 How to select participants? 81 -- 12.3.2 Can research be conducted with participants in vulnerable situations (including children under 18 years old)? 82 -- 12.3.3 Can proxies be recruited as participants? 84 -- 12.3.4 Can representatives be recruited as participants? 85 -- 12.3.5 Which type of sample? 87 -- 12.3.6 What is the expected sample size? 91 -- 12.3.7 How to recruit participants? 92 -- 12.3.8 Is it possible to accelerate the recruitment process? 94 -- 12.3.9 Should the recruitment be done via gatekeepers? 94 -- 12.3.10 Should participants be paid in a primary data collection process? 95 -- 12.3.11 Where to find participants? 95 -- 12.3.12 How to manage the follow-up of the recruitment process? 95 -- 12.3.13 How to manage the first contact with a participant 96 -- 12.4 HOW TO DEVELOP THE DATA COLLECTION MATERIAL? 97 -- 12.4.1 How to construct a topic list or an interview guide? 97 -- 12.4.2 What types of questions can be asked during an interview? 98 -- 12.4.3 Should the same data collection material be used for interviews and focus groups? 99 -- 12.4.4 Should enabling techniques be used? 100 -- 12.4.5 Should the data collection material be pilot tested? 101 -- 12.5 HOW TO RUN THE DATA COLLECTION? 101 -- 12.5.1 Should moderation and interviewing always be performed by qualitative researchers? 101 -- 12.5.2 Can the data collection benefit from an online approach? 102 -- 12.5.3 How to prepare for the interview? 108 -- 12.5.4 How to conduct the interview? 109 -- 12.5.5 How to take notes during an interview? 111 -- 12.5.6 What are memos and summaries? 112 -- 12.5.7 Should interpreters be used for the data collection? 112 -- 13. MORE THAN WHAT PEOPLE SAY: NATURALISTIC OBSERVATION 114 -- 13.1 SHOULD THE STUDY INCLUDE OBSERVATIONS? 114 -- 13.2 WHAT ARE THE STRENGTHS OF (NATURALISTIC) OBSERVATION, AND FOR WHAT PURPOSES? 115 -- 13.3 WEAKNESSES OF OBSERVATIONS 116 -- 13.4 HOW TO PLAN THE RESEARCH DESIGN? 117 -- 13.5 MODALITIES OF DATA COLLECTION 117 -- 13.5.1 Participant versus direct observation 117 -- 13.5.2 Structured versus unstructured observation 118 -- 13.5.3 Overt versus covert observation 118 -- 13.5.4 Types of observation techniques 118 -- 13.5.5 Data collection tools 119 -- 13.5.6 Sampling 121 -- 13.5.7 Required human resources 121 -- 13.5.8 Practical aspects 122 -- 13.6 HOW TO ANALYSE DATA FROM OBSERVATIONS? 122 -- 13.7 HOW TO REPORT THE FINDINGS OF OBSERVATIONS? 122 -- 13.8 SPECIFIC QUALITY CRITERIA 122 -- 14. WHAT PEOPLE SAYS WITHOUT INTERACTION: INTERVIEWS 123 -- 14.1 SHOULD THE STUDY INCLUDE INDIVIDUAL INTERVIEWS? 123 -- 14.2 WHAT ARE INDIVIDUAL INTERVIEWS? 123 -- 14.3 WHEN TO USE INDIVIDUAL SEMI-STRUCTURED INTERVIEWS? 124 -- 14.4 STRENGTHS AND WEAKNESSES OF INDIVIDUAL SEMI-STRUCTURED INTERVIEWS 125 -- 14.5 MODALITIES OF DATA COLLECTION 125 -- 14.5.1 Choosing the place of the interview 125 -- 14.5.2 Choosing the interviewer 126 -- 14.5.3 Is there a possibility to restrict the languages used when conducting interviews? 126 -- 14.6 DATA COLLECTION TOOLS 127 -- 14.7 REQUIRED HUMAN RESOURCES 127 -- 14.8 HOW TO ACCELERATE THE DATA COLLECTION BY INTERVIEWS? 127 -- 15. SYNCHRONOUS INTERACTIONS BETWEEN PARTICIPANTS: FOCUS GROUPS 129 -- 15.1 SHOULD THE STUDY INCLUDE FOCUS GROUPS? 129 -- 15.2 WHAT ARE FOCUS GROUPS? 130 -- 15.3 WHEN TO USE FOCUS GROUPS? 131 -- 15.4 STRENGTHS AND WEAKNESSES OF USING FOCUS GROUPS 131 -- 15.5 SPECIFIC ASPECTS OF SAMPLING FOR FOCUS GROUPS 132 -- 15.5.1 Identification of units of analysis 132 -- 15.5.2 Composition of the groups 132 -- 15.5.3 Number of participants per group 132 -- 15.5.4 Number of groups 133 -- 15.5.5 Strategies to accelerate the recruitment process in RQR 133 -- 15.6 DATA COLLECTION TOOLS 134 -- 15.7 REQUIRED HUMAN RESOURCES 134 -- 15.7.1 Focus groups in a single language 134 -- 15.7.2 Focus-groups in two languages 135 -- 15.8 HOW TO RUN THE DATA COLLECTION IN A FOCUS GROUP? 136 -- 15.8.1 Should the focus group be held in hybrid format? 136 -- 15.8.2 How to prepare for a focus group? 136 -- 15.8.3 How to run the focus group? 137 -- 15.9 SPECIFIC PRACTICAL ASPECTS RELATED TO FOCUS GROUPS 138 -- 15.9.1 Location and timing 138 -- 15.9.2 Duration 139 -- 15.9.3 Material 139 -- 15.10 HOW TO ANALYSE DATA FROM FOCUS GROUPS? 140 -- 15.11 HOW TO REPORT FINDINGS FROM FOCUS GROUPS? 140 -- 16. ASYNCHRONOUS INTERACTIONS BETWEEN PARTICIPANTS: RESEARCH FORUM 140 -- 16.1 SHOULD THE STUDY INCLUDE A RESEARCH FORUM? 140 -- 16.2 WHAT IS A RESEARCH FORUM? 141 -- 16.3 STRENGTHS AND WEAKNESSES OF RESEARCH FORUM 141 -- 16.4 MODALITIES OF DATA COLLECTION 142 -- 16.5 DATA COLLECTION TOOLS 143 -- 16.6 SPECIFIC ASPECTS OF SAMPLING FOR RESEARCH FORUM 143 -- 16.7 REQUIRED HUMAN RESOURCES 143 -- 16.7.1 Forum administrator 143 -- 16.7.2 Forum moderator 144 -- 16.8 HOW TO RUN THE DATA COLLECTION IN A RESEARCH FORUM? 144 -- 16.9 SPECIFIC PRACTICAL ASPECTS RELATED TO RESEARCH FORUM 144 -- 16.9.1 Location 144 -- 16.9.2 Duration 144 -- 16.10 HOW TO ANALYSE DATA FROM A RESEARCH FORUM? 144 -- 16.11 HOW TO REPORT FINDINGS FROM A RESEARCH FORUM? 144 -- 17. CONSENSUS WITHOUT INTERACTIONS: DELPHI PROCESS 145 -- 17.1 SHOULD THE STUDY INCLUDE A DELPHI PROCESS? 145 -- 17.2 WHAT IS A DELPHI PROCESS? 145 -- 17.3 WHY AND WHEN TO USE A DELPHI PROCESS? 146 -- 17.4 STRENGTHS AND WEAKNESSES OF THE DELPHI PROCESS 147 -- 17.5 HOW TO PLAN THE RESEARCH DESIGN? 147 -- 17.6 MODALITIES OF DATA COLLECTION 150 -- 17.7 DATA COLLECTION TOOLS 150 -- 17.8 SPECIFIC ASPECTS OF SAMPLING FOR THE DELPHI PROCESS 151 -- 17.9 REQUIRED HUMAN RESOURCES 151 -- 17.10 PRACTICAL ASPECTS 151 -- 17.11 HOW TO ANALYSE? 151 -- 17.12 HOW TO REPORT THE FINDINGS? 152 -- 17.13 SPECIFIC QUALITY CRITERIA 153 -- 18. CONSENSUS WITH INTERACTIONS: NOMINAL GROUPS 153 -- 18.1 SHOULD THE STUDY INCLUDE THE NOMINAL GROUPS? 153 -- 18.2 WHAT ARE NOMINAL GROUPS? 153 -- 18.3 WHY AND WHEN TO USE NOMINAL GROUPS? 153 -- 18.4 STRENGTHS AND WEAKNESSES OF NOMINAL GROUPS 154 -- 18.5 HOW TO ORGANISE NOMINAL GROUPS? 155 -- 18.5.1 Group size and length 155 -- 18.5.2 Nominal groups technique essentials 155 -- 18.5.3 Process 157 -- 18.5.4 Practical aspects 160 -- 18.6 SPECIFIC QUALITY CRITERIA 160 -- PART 4 – QUALITATIVE DATA ANALYSIS 161 -- 19. FREQUENTLY ASKED QUESTIONS IN QUALITATIVE DATA ANALYSIS 161 -- 19.1 SHOULD ALL THE DATA BE COLLECTED BEFORE STARTING THE ANALYSIS? 161 -- 19.2 SHOULD THE RESEARCHER IN CHARGE OF DATA COLLECTION CONDUCT THE DATA ANALYSIS? 161 -- 19.3 SHOULD ONE RESEARCHER CONDUCT THE ENTIRE ANALYSIS OF THE CORPUS? 162 -- 19.4 CAN THE ANALYSIS PROCESS BE EXPEDITED? 162 -- 19.5 SHOULD THE DATA BE ANALYSED ACCORDING TO THEIR SOURCE? 162 -- 19.6 SHOULD THE DATA BE ANALYSED WITH A QUALITATIVE DATA ANALYSIS SOFTWARE? 162 -- 20. THEORETICAL APPROACHES FOR QUALITATIVE DATA ANALYSIS 164 -- 20.1 ANALYTIC APPROACHES 164 -- 20.1.1 Thematic content analysis 164 -- 20.1.2 Analysis using conceptualising categories 165 -- 20.1.3 Phenomenological examination of the empirical data 166 -- 20.2 HOW TO CHOOSE THE ANALYTICAL APPROACH 166 -- 20.3 APPROACH TO QUALITATIVE DATA ANALYSIS AT KCE 166 -- 21. ANALYTIC JOURNEY 167 -- 21.1 PREPARING THE DATA FOR ANALYSIS 167 -- 21.2 FAMILIARISATION 168 -- 21.3 CODING THE DATA 168 -- 21.3.1 Initial coding 168 -- 21.3.2 Thematization 169 -- 21.3.3 Refine and regroup categories 170 -- 21.3.4 Constant comparison 172 -- 21.3.5 Accelerating the coding process 172 -- 21.4 NEW DATA COLLECTION (OPTIONAL) 173 -- 21.5 ABSTRACTION AND INTERPRETATION 173 -- 21.6 DESCRIPTION OF THE FINDINGS AND REPORTING 174 -- PART 5 - QUALITATIVE DATA REPORTING 175 -- 22. QUALITATIVE DATA REPORTING 175 -- 22.1 HOW TO REPORT QUALITATIVE RESEARCH FINDINGS? 175 -- 22.1.1 Is there a standardised structure for reporting qualitative findings? 175 -- 22.1.2 How to present the qualitative research methods used? 176 -- 22.1.3 How to present qualitative findings? 178 -- 22.2 HOW TO USE QUOTES? 18
