Introduction. Health-related quality of life (HRQOL) is a multidimensional concept, which subjectively measures a patient's physical, social, and emotional well-being. This information is becoming increasingly important in policy and clinical decisions. With such a wide range of tools available, careful selection is required to ensure they adequately reflect patient's concerns.
Aim. To critically assess HRQOL instruments used in studies of testosterone deficiency syndrome (TDS) to see whether they accurately measure these concerns.
Methods. A systematic review identified published articles. Studies were included if the population was adult men with TDS, with or without comorbid disease; used one or more HRQOL tools; and described the impact of treatment, the impact of TDS on the patient or the development of a questionnaire. Measurement properties and their use in clinical studies were described. Each study was assessed against 10 clinical face validity criteria to evaluate whether the questionnaires reflected issues that were of concern to patients.
Main Outcome Measure. Review of published literature.
Results. The study identified 29 articles that included 14 HRQOL questionnaires selected for use in 20 intervention studies, seven studies of the impact of TDS on the patient, and two studies describing the development of a HRQOL tool. Questionnaires displayed variable measurement properties and only nine studies complied with more than 50% of the clinical face validity criteria. Disease-specific instruments achieved a higher rate of compliance and more often demonstrated a positive effect of treatment on HRQOL compared to generic instruments.
Conclusion. Instruments used to measure HRQOL display variable measurement properties and often lack adequate clinical face validity. There are well-validated disease-specific HRQOL measures for age-related TDS, but none for classical TDS patients. Clinical and political decision-makers require HRQOL information using a combination of well-validated generic questionnaires and patient-focused, disease specific instruments relevant to the target TDS population under study. Langham S, Maggi M, Schulman C, Quinton R, and Uhl-Hochgraeber K. Health-related quality of life instruments in studies of adult men with testosterone deficiency syndrome: A critical assessment. J Sex Med **;**:**–**.