title: Lack of Health-Related Quality of Life and Patient-Centred Outcome Measures in Randomized Controlled Trials Conducted for Diabetes Pharmacotherapy: SGLT-2 Receptor Inhibitors as An Example.
abstract: Use of SGLT-2 receptor inhibitors has been associated with weight loss and a low rate of hypoglycemia in comparison to sulfonylureas. These factors may improve health-related quality of life for patients with diabetes.
  
  
  
  To systematically explore randomized controlled trials (RCTs) involving SGLT-2 receptor inhibitors that reported health-related quality of life changes.
  
  
  
  A systematic review of SGLT-2 receptor inhibitors clinical trials, limited to RCTs and English language, was conducted utilizing PubMed databases.
  
  
  
  One-hundred and eighteen RCTs were reviewed and 62 RCTs meeting the inclusion criteria were assessed. All 62 RCTs reported body mass index (BMI) changes and HgbA1c reduction. Measures of health-related quality-of-life (HRQoL) were reported in only 2 RCTs. Both studies illustrate improvement in HRQoL domains for SGLT-2 receptor inhibitors in comparison to the other arms in the RCTs.
  
  
  
  Only a small portion of RCTs involving SGLT-2 receptor inhibitors reported on HRQoL. Because of the potential for weight loss and hypoglycemia avoidance to improve HRQoL, future studies of SGLT-2 receptor inhibitors should measure and report on patient-centred outcomes such as HRQoL.
authors.affiliation: Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario.
authors.forename: Pendar
authors.initials: P
authors.lastname: Farahani
mesh_terms: D015992:Body Mass Index; D003920:Diabetes Mellitus / Q000188:drug therapy*; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018802:Patient-Centered Care; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D000077203:Sodium-Glucose Transporter 2 Inhibitors; D013453:Sulfonylurea Compounds / Q000627:therapeutic use; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000077203:Sodium-Glucose Transporter 2 Inhibitors; D013453:Sulfonylurea Compounds
keywords: SGLT-2; diabetes; hypoglycemia; obesity; quality of life; sulfonylurea