Assessing Symptom Burden and Health-Related Quality of Life in patients living with arrhythmia and ASTA Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia

.................................................................................................................. 1 LIST OF PAPERS ........................................................................................................ 3 ABBREVIATIONS ....................................................................................................... 5 INTRODUCTION ......................................................................................................... 7 AIMS OF THE THESIS ............................................................................................... 9 BACKGROUND ......................................................................................................... 11 Arrhythmias ......................................................................................................... 11 Definition, prevalence and diagnosis .................................................................. 11 AV-Nodal reentry tachycardia and Wolff-Parkinson-White syndrome .......... 11 Atrial fibrillation .............................................................................................. 12 Other arrhythmias ............................................................................................... 12 Atrial flutter ..................................................................................................... 12 Other atrial macro-reentry arrhythmias ........................................................... 13 Focal Atrial Tachycardia ................................................................................. 13 Ventricular arrhythmias ................................................................................... 13 Treatment options for arrhythmia-patients ...................................................... 14 Symptoms and symptom burden ........................................................................ 15 Health, Quality of Life and Health-Related Quality of Life ............................ 16 Health and Quality of Life ............................................................................... 16 Health-Related Quality of Life ........................................................................ 17 Assessment of symptom burden and Health-Related Quality of Life in arrhythmia-patients with patient-reported outcomes ....................................... 18 Conceptualizing assessment of symptom burden and Health-Related Quality of Life .................................................................................................................... 20 Conceptualizing symptom burden and Health-Related Quality of Life assessment in the ASTA questionnaire ............................................................ 21 Conceptual model for the development of the disease-specific questionnaire ASTA ............................................................................................................... 22 METHODS .................................................................................................................. 23 Design and Setting................................................................................................ 23 Participants ........................................................................................................... 26 Study I .............................................................................................................. 26 Study II ............................................................................................................ 26 Study III ........................................................................................................... 27 Study IV ........................................................................................................... 28 Data collection ...................................................................................................... 30 Procedures ........................................................................................................ 30 Questionnaires used in the studies ..................................................................... 31 SF-36 ................................................................................................................ 31 EQ-5D .............................................................................................................. 32 SCL .................................................................................................................. 32 Development of the ASTA questionnaire .......................................................... 33 ASTA symptom burden ................................................................................... 33 ASTA Health-Related Quality of Life ............................................................. 34 Development and initial testing of the ASTA questionnaire ........................... 35 Statistical analysis of data ................................................................................... 39 Statistical tests in Studies I and II .................................................................... 39 Statistical tests in Studies III and IV ................................................................ 40 ETHICAL CONSIDERATIONS ............................................................................... 43 RESULTS .................................................................................................................... 45 Symptom burden .................................................................................................. 45 Health-Related Quality of Life ........................................................................... 46 The ASTA questionnaire ..................................................................................... 47 Data quality ...................................................................................................... 48 Validity ............................................................................................................ 48 Reliability (homogeneity) ................................................................................ 52 DISCUSSION .............................................................................................................. 53 Symptom burden .................................................................................................. 53 Health-Related Quality of Life ........................................................................... 54 The ASTA questionnaire ..................................................................................... 57 Data quality ...................................................................................................... 57 Validity ............................................................................................................ 58 Reliability (homogeneity) ................................................................................ 60 Methodological issues and limitations in Studies I-IV ..................................... 62 CONCLUSION ........................................................................................................... 65 CLINICAL IMPLICATIONS ................................................................................... 66 FUTURE ...................................................................................................................... 67 SVENSK SAMMANFATTNING .............................................................................. 68 ACKNOWLEDGEMENTS ....................................................................................... 70 APPENDIX 1 ............................................................................................................... 74 The ASTA questionnaire ..................................................................................... 74 ASTA background data ................................................................................... 74 ASTA symptom burden ................................................................................... 74 ASTA Health-Related Quality of Life ............................................................. 74 Recommendations for scoring of the ASTA questionnaire .............................. 75 General scoring information ............................................................................ 75 ASTA symptom burden scale .......................................................................... 75 ASTA symptoms near syncope and syncope................................................... 75 ASTA Health-Related Quality of Life ............................................................. 75 Transforming of scale scores ........................................................................... 76 REFERENCES ............................................................................................................ 79