OBJECTIVES To identify and summarize the key characteristics, strengths, and weaknesses of available patient-reported outcome (PRO) measures assessing treatment satisfaction and health-related quality of life (HRQOL) related to anticoagulation therapy in patients with atrial fibrillation, including evaluating how well the measures meet current regulatory guidance requirements in Europe and the United States. METHODS Publications describing the development, validation, or use of PRO instruments in patients using anticoagulant therapy were identified through a comprehensive literature review. Several sources (PubMed, Patient-Reported Outcome and Quality of Life Instruments Database [PROQOLID], and ClinicalTrials.org) were reviewed to identify instruments. The development process and measurement properties (internal consistency and test-retest reliability, convergent and divergent construct validity, known-groups validity, and responsiveness) of the identified instruments were compared. RESULTS Five measures assessing anticoagulation-related PROs were identified: 1) Sawicki questionnaire (assesses treatment satisfaction and HRQOL); 2) Perception of Anticoagulant Treatment Questionnaire (PACT-Q); 3) Duke Anticoagulation Satisfaction Scale (DASS); 4) Anti-Clot Treatment Scale (ACTS) (based on the DASS conceptual model); and 5) Deep Venous Thrombosis Quality of Life (DVTQOL) (assesses HRQOL outcomes related to a primary event of DVT and includes items assessing anticoagulation burden). All of the measures except the Sawicki questionnaire involved anticoagulated patients in the process of item generation and refinement. The ACTS and the DASS exhibited the strongest measurement properties. To a limited degree, the ACTS, DASS, and Sawicki questionnaire have demonstrated responsiveness in clinical trial settings. CONCLUSIONS Although some of the identified measures have shown responsiveness in clinical trials, this review concluded that no existing measure appears likely to support an FDA or EMA PRO label claim in anticoagulation-related treatment satisfaction or HRQOL. However, concepts related to anticoagulation treatment satisfaction and HRQOL are important to patients and should be included in clinical trials, particularly as the burdens and benefits of anticoagulants evolve over time.