Non-Interventional, cross-sectional study to describe health-related quality of life among controlled and uncontrolled patients with nonvalvular atrial fibrillation on anticoagulants (RE-QUOL study)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Evaluation of patient-reported outcomes
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medicinal product name:
  PRADAXA
• Study drug International non-proprietary name (INN) or common name:
  DABIGATRAN ETEXILATE
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AE07) dabigatran etexilate

  dabigatran etexilate
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Nonvalvular AF (NVAF) patients with uncontrolled anticoagulation status treated with VKA, and of NVAF patients with controlled anticoagulation status treated with vitamin K antagonists (VKA) or direct oral anticoagulants (DOAC).; Inclusion criteria were:; 1. The patient is willing and provides written informed consent to participate in this study.; 2. The patient is at least 18 years of age.; 3. The patient has a diagnosis of non-valvular atrial fibrillation.; 4. The patient is on the same anticoagulant therapy (VKA or DOAC) during at least 6 months and maximum 2 years.; 5. If treated with VKA, availability of %TTR in past analytical records or enough amount of INR measures to calculate it.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Non-valvular atrial fibrillation (NVAF) patients
• Estimated number of subjects:
  500

Study design details

• Study design:
  Observational multicenter and cross-sectional study
• Main study objective:
  The primary objective of the study is to describe the HRQoL in uncontrolled patients treated with VKA and controlled patients treated with VKA or DOAC.
• Setting:
  This study was conducted in the Autonomous Communities of Madrid, Valencia and Andalucía (Spain). Forty-seven internal medicine specialists from 38 Hospital sites regularly prescribing DOACs and VKA for stroke prevention in NVAF according to the respective Summary of Product Characteristics (SmPC) participated in the study.
• Outcomes:
  The primary outcome is the health-related quality of life and will be obtained with the results of the sawicki questionnaire at study visit. The questionnaire includes 32 itemsgrouped in 5 dimensions. Patients will estimate the impact of each item on their selfperceived treatment-related quality of life on a scale of 1 (total disagreement) to 6 (total agreement). The secondary outcome is the uncontrolled patient profile and will be defined by thefollowing variables collected from patient medical records.
• Data analysis plan:
  The primary outcome of the study is the health-related quality of life as measured by the Sawicki questionnaire. The scores of each individual question will be summarized descriptively in the controlled and uncontrolled patients. In addition, the summary score for each dimension of the questionnaire will be calculated for each patient by dividing the total score by the number of items included in that dimension and summarized in the same way as the individual questions.
• Summary results:
  DISCUSSION; The study presented HRQoL perceptions of NVAF patients on anticoagulants, either controlled or uncontrolled, assessed by the validated Spanish adaptation of the Sawicki questionnaire, which included five different dimensions (general treatment satisfaction, self-efficacy, distress, daily hassles and strained social network). From a descriptive point of view, controlled patients (treated with DOAC or VKA) had mean scores closer to a high perceived HRQoL in the 5 dimensions of the questionnaire, with remarkably high scores for general treatment satisfaction. These results suggest that TTR control might influence perceptions of HRQoL and highlight the importance of evaluate anticoagulation status, when assessing HRQoL.An understanding of the factors that influence HRQoL is required in order to adapt economic evaluations to the characteristics of a specific patient ; population and assess the clinical and cost-effectiveness of different therapeutic alternatives. Our study provided a detailed description of the demographic and clinical profile of uncontrolled NVAF patients on anticoagulants, which should warrant further exploration of the extent to which particular demographic and clinical characteristics of these patients might influence perceptions of their HRQoL.;