Clinical Scales for Headache Disorders

Description

This book provides an overview of planning and examining the methodology, analytic issues, primary and secondary endpoints and outcomes in headache trials. Throughout the book, guidance on how to design a high quality study and how to evaluate which study has relevant scientific qualification is discussed in detail. Clinical scales and patient related outcome measures (PROMs) to exclude secondary headaches, to diagnose primary headache disorders, to evaluate patients’ health-related quality of life, to detect psychiatric comorbidities, to assess patients’ headache-related disability and to monitor patients’ treatment optimization are clearly and concisely outlined in the chapters.   Clinical Scales for Headache Disorders highlights the components for planning an effective headache study including interpretation of primary and secondary endpoints, common clinical scales, PROMs and their clinical reliability and validation. Both clinicians and researchers will find this book to be a useful tool for their medical and academic practices on headache and migraine. Foreword Preface Acknowledgement Contents Chapter 1: What Is the Best Methodology for Headache or Migraine Research? 1.1 Introduction 1.2 Conclusions References Chapter 2: Clinical Scales for Headache and Migraine 2.1 Introduction 2.2 Diagnostic Screeners for Headache and Migraine (Table 2.1) 2.2.1 SNOOP 2.2.2 ID Migraine™ 2.2.3 The Erwin Test for Cluster Headache 2.2.4 The Brief Headache Screen (BHS) 2.2.5 Migraine Screen Questionnaire (MS-Q) 2.2.6 The Computerized Headache Assessment Tool (CHAT) 2.2.7 The Headache Under-Response to Treatment (HURT) 2.3 Scales for Impact, Disability, and Burden of Headache and Migraine (Table 2.5) 2.3.1 Headache Specific Impact 2.3.1.1 Headache Impact Test (HIT-6) 2.3.1.2 Headache-Attributed Lost Time (HALT-90) Index 2.3.1.3 Henry Ford Headache Disability Inventory (HDI) 2.3.1.4 Headache Impact Questionnaire (HImQ) 2.3.1.5 Cluster Headache Impact Questionnaire (CHIQ) 2.3.1.6 Headache-Attributed Restriction, Disability, Social Handicap and Impaired Participation (HARDSHIP) Questionnaire 2.3.1.7 Headache Activities of Daily Living Index (HADLI) 2.3.1.8 Headache Disability Questionnaire (HDQ) 2.3.1.9 Headache Needs Assessment Survey (HANA) 2.3.2 Migraine Specific Impact (Table 2.6) 2.3.2.1 Migraine Severity (MIGSEV) Scale 2.3.2.2 Migraine Disability Assessment Questionnaire (MIDAS) 2.3.2.3 Functional Assessment in Migraine (FAIM) Questionnaire 2.3.2.4 Migraine Interictal Burden Scale-4 (MIBS-4) 2.3.2.5 Migraine Functional Impact Questionnaire (MFIQ) 2.4 Scales for Generic and Migraine Specific Health-Related Quality of Life (HRQoL) (Table 2.7) 2.4.1 Generic HRQoL Scales 2.4.1.1 Short Form (SF) 36 (SF-36) (SF-12) (SF-8) 2.4.1.2 EuroQoL Quality of Life Scale (EQ-5D) 2.4.2 Migraine Specific HRQoL Scales 2.4.2.1 Migraine Specific Quality of Life (MSQ v2.1) Version 2.1 2.5 Scales for Treatment Monitoring and Optimization of Headache and Migraine (Table 2.8) 2.5.1 Completeness of Response to Migraine Therapy (CORS) 2.5.2 Migraine Assessment of Current Therapy (Migraine-ACT) 2.5.3 Migraine-Treatment Assessment Questionnaire (M-TAQ) 2.5.4 Migraine-Treatment Optimization Questionnaire (M-TOQ) 2.5.5 Migraine-Treatment Satisfaction Measure (MTSM) 2.5.6 Patient Perception of Migraine Questionnaire-Revised (PPMQ-R) 2.6 Conclusions References Chapter 3: Reliability and Validity of Clinical Scales Measurement 3.1 Introduction 3.2 Developing a Clinical Scale 3.3 Measurement of a Clinical Scale 3.3.1 Basic Concept 3.3.2 Measurement Tools 3.4 Assessment 3.4.1 Basic Concept 3.4.2 Domain-Referenced Assessment 3.4.3 Cut-Off Score-Based Assessment 3.4.4 Rank-Based Assessment 3.4.5 Norm-Referenced Assessment 3.5 Qualification Requirements for Clinical Measurement Tools 3.5.1 Reliability 3.5.1.1 Methods to Assess Reliability in Clinical Scales 3.5.2 Validity 3.5.2.1 Measurement Validity Content Validity Criterion-Related Validity Construct Validity 3.5.2.2 Decision Validity 3.5.2.3 A Rundown on Reliability and Validity in Clinical Scales 3.5.3 Error in Measurement 3.5.3.1 Standard Error of Measurement 3.6 Reliability Methods for Clinical Scales 3.6.1 Method for Multiple Applications 3.6.1.1 Alternate Form Method 3.6.1.2 Test-Retest Method 3.6.2 Methods Based on a Single Application 3.6.2.1 Split-Half Method The Conventional Method and Spearman-Brown Prophecy 3.6.2.2 Rulon Method 3.6.2.3 Guttman’s Method 3.6.3 Methods Based on Inter-item Covariance 3.6.3.1 Kuder-Richardson Method (KR-20) 3.6.3.2 Cronbach’s Alpha Method 3.7 Conclusions References Chapter 4: Patient Reported Outcome Measures (PROMs) in Migraine and Headache 4.1 Introduction 4.2 Patient Report Outcomes and Patient Reported Outcome Measures 4.2.1 Definitions 4.2.2 Patient Reported Outcome Measures (PROMs) Used in Migraine Clinical Trials 4.2.3 PROMS That Meet Standards for Use in Clinical Trials and Labeling 4.2.4 How to Develop, Validate and Evaluate PROMs 4.2.4.1 Regulatory Guidance on the Development and Necessary Qualities of PROMs 4.2.4.2 Phases of PROM Development and Validation 4.2.4.3 How to Interpret PROs in Trials and Clinical Practice 4.3 Discussion References Chapter 5: Measuring Pain Intensity in Headache Trials 5.1 Introduction 5.2 Unimodal Pain Intensity Scales 5.2.1 The Four-Point Verbal Rating Scale 5.2.2 The Six-Point Verbal Rating Scale 5.2.3 The Numerical Rating Scale 5.2.4 The Visual Analogue Scale 5.2.4.1 The Faces Pain Scale-Revised 5.3 Multimodal Pain Intensity Scales 5.3.1 The McGill Pain Questionnaire 5.3.2 Brief Pain Inventory 5.4 Pain Scales in Clinical Trials and Practice 5.5 Conclusion References Chapter 6: Clinical Instruments for Diagnosing and Screening of Headache and Migraine 6.1 Introduction 6.2 The International Classification of Headache Disorders 6.2.1 Migraine Without Aura 6.2.2 Migraine with Aura 6.2.3 Chronic Migraine 6.3 Primary or Secondary Etiology: Red and Green Flags in Headache 6.3.1 Red Flags (SNNOOP10) 6.3.2 Green Flags 6.3.3 Red Flags and Green Flags in Clinical Practice 6.4 Screening Tools for Headache 6.4.1 Brief Headache Screen (BHS) 6.4.2 Computerized Headache Assessment Tool (CHAT) 6.4.3 ID Migraine Screener 6.4.4 Identify Chronic Migraine (ID-CM) 6.4.5 Migraine Screen Questionnaire (MS-Q) 6.4.6 The Erwin Test for Cluster Headache (ETCH) 6.5 Conclusions References Chapter 7: Clinical Instruments for Disability, Impact and Burden in Headache and Migraine 7.1 Introduction 7.1.1 The Migraine Severity Scale (MIGSEV) 7.1.2 The Headache Impact Questionnaire (HImQ) 7.1.3 Migraine Disability Assessment Scale (MIDAS) 7.1.4 Headache-Attributed Lost Time (HALT) Index 7.1.5 Headache Impact Test (HIT) 7.1.6 Functional Assessment in Migraine (FAIM) Questionnaire 7.1.7 The Headache Needs Assessment (HANA) Survey 7.1.8 The Migraine Interictal Burden Scale (MIBS-4) 7.1.9 The Henry Ford Hospital Headache Disability Inventory (HDI) 7.1.10 Headache Activity of Daily Living Index (HADLI) 7.1.11 Burden of Migraine Instrument (BURMIG) 7.1.12 EUROLIGHT Questionnaire 7.1.13 Headache-Attributed Restriction, Disability, Social Handicap and Impaired Participation (HARDSHIP) Questionnaire 7.1.14 Migraine Physical Function Impact Diary (MPFID) 7.1.15 The Migraine Functional Impact Questionnaire (MFIQ) 7.1.16 Migraine Work and Productivity Loss Questionnaire (MWPLQ) 7.1.17 HEADWORK 7.2 Conclusion References Chapter 8: Patient-Reported Outcomes in Migraine and Cluster Headache 8.1 Introduction 8.2 PROs in Migraine 8.2.1 Premonitory Symptoms 8.2.2 Migraine Triggers 8.3 PROs in Cluster Headache 8.4 Conclusion References Chapter 9: Clinical Scales for Psychiatric Comorbidities and Cognitive Processes in Headache and Migraine 9.1 Introduction 9.2 Clinical Scales for Psychiatric Comorbidities in Headache and Migraine 9.2.1 Personality Traits and Mood or Anxiety Disorder 9.2.2 Anxiety and Depression 9.2.2.1 Anxiety 9.2.2.2 Depression 9.2.2.3 Mixed Instruments for Anxiety and Depression 9.2.3 PTSD 9.3 Clinical Scales to Assess Cognitive Status and Aspects in Pain Processing in Headache and Migraine 9.4 Conclusion References Chapter 10: Clinical Instruments for Treatment Monitoring and Optimization in Headache and Migraine 10.1 Introduction 10.2 Generic Instruments 10.2.1 Headache Under Response to Treatment (HURT) Questionnaire 10.2.2 Medication Dependence Questionnaire in Headache 10.2.3 Treatment Satisfaction Questionnaire for Medication (TSQM) 10.2.4 Screener and Opioid Assessment for Patients with Pain Revised 10.2.5 Current Opioid Misuse Measure 10.3 Migraine-Specific Instruments 10.3.1 Migraine Assessment of Current Therapy 10.3.2 Migraine Treatment Optimization Questionnaire 10.3.3 Patient Perception of Migraine Questionnaire Revised 10.3.4 Migraine Therapy Assessment Questionnaire 10.3.5 Migraine Prevention Questionnaire 10.3.6 Migraine Completeness of Response Survey 10.3.7 Migraine Treatment Satisfaction Measure 10.4 Conclusions References Chapter 11: Other Questionnaires We Don’t Want to Miss in Headache Studies 11.1 Introduction 11.1.1 Migraine Attacks-Subjective Cognitive Impairments Scale (Mig-SCog Scale) 11.1.2 Work Productivity and Activity Impairment Questionnaire (WPAI) 11.1.3 The Headache Triggers Sensitivity and Avoidance Questionnaire (HTSAQ) 11.1.4 Patient Global Impression of Change Scale (PGIC) 11.1.5 Patient Perception of Migraine Questionnaire-Revised (PPMQ-R) 11.1.6 Chronic Pain Acceptance Questionnaire (CPAQ-8) 11.1.7 The Headache Acceptance Questionnaire (HAQ) 11.1.8 The Loneliness of Migraine Scale (LMS) 11.1.9 Severity of Dependence Scale (SDS) 11.1.10 Quantitative Sensory Testing (QST) 11.2 Conclusion References Chapter 12: Clinical Scales for Special Groups 12.1 Introduction 12.2 Pain Severity Scales 12.3 Disability Scales 12.4 Psychiatric Comorbidity Assessment Scales 12.5 School Based Tool 12.6 Conclusion References Appendix Development and Validation of the Headache Needs Assessment (HANA) Survey The Headache Triggers Sensitivity and Avoidance Questionnaire The Headache Triggers Sensitivity and Avoidance Questionnaire Brief Headache Screen The Validity and Reproducibility of a Work Productivity and Activity Impairment Instrument Permission to Use the WPAI WPAI Scoring Chronic Pain Acceptance Questionnaire (CPAQ) The Migraine Therapy Assessment Questionnaire The Development of a Survey to Measure Completeness of Response to Migraine Therapy The Development of a Survey to Measure Completeness of Response to Migraine Therapy The Hospital Anxiety and Depression Scale EuroQoL Quality of Life Scale (EQ-5D) Short Form 36 (SF-36) Short Form 12 (SF-12) Headache Disability Questionnaire (HDQ) Migraine Interictal Burden Scale-4 (MIBS-4) Migraine Specific Quality of Life Questionnaire ( Version 2.1) Red and Orange Flags for Secondary Headaches in Clinical Practice The SNNOOP10 List of Red Flags Green Flags for Headache Disorders ID Migraine Screener Migraine Screen Questionnaire The Erwin Test for Cluster Headache Wong-Baker Faces Pain Rating Scales Headache-Attributed Lost Time (HALT-90) Index HARDSHIP Questionnaire Cluster Headache Impact Questionnaire (CHIQ) Headache Disability Questionnaire (HDQ)