INTRODUCTION: In the highly active antiretroviral therapy (HAART) era, HIV-related diarrhea remains common. There is no gold standard to measure diarrhea, making comparison across trials difficult. We conducted a systematic review to determine current research practice in measuring HIV-related diarrhea. METHOD: MEDLINE was searched from 1980 to 2006 for clinical trials of treatment for HIV-related diarrhea. The following data were abstracted: type of trial, treatment studied, definition of diarrhea, and definition of improvement in diarrhea. RESULTS: We reviewed 384 articles; 46 met our inclusion criteria. Forty-two trials were prospective: 25 were open-label and 17 were controlled trials. Antimicrobials were studied most often (15 trials): octreotide was studied in 10 trials, and HAART in 5. Presence of diarrhea was most often defined by duration (33 trials, 72%), stool frequency (29 trials, 63%), and/or stool form (23 trials, 50%); often, more than one parameter was used. Stool frequency was used most often to measure diarrhea improvement (28 trials, 61%). Only one trial used a measure validated for HIV-related diarrhea. CONCLUSION: Investigators rely on non-validated and disparate measures of HIV-related diarrhea. An easy-to-use, well-accepted, and valid tool to measure HIV-related diarrhea would enhance research in this field.
INTRODUCTION: In the highly active antiretroviral therapy (HAART) era, HIV-related diarrhea remains common. There is no gold standard to measure diarrhea, making comparison across trials difficult. We conducted a systematic review to determine current research practice in measuring HIV-related diarrhea. METHOD: MEDLINE was searched from 1980 to 2006 for clinical trials of treatment for HIV-related diarrhea. The following data were abstracted: type of trial, treatment studied, definition of diarrhea, and definition of improvement in diarrhea. RESULTS: We reviewed 384 articles; 46 met our inclusion criteria. Forty-two trials were prospective: 25 were open-label and 17 were controlled trials. Antimicrobials were studied most often (15 trials): octreotide was studied in 10 trials, and HAART in 5. Presence of diarrhea was most often defined by duration (33 trials, 72%), stool frequency (29 trials, 63%), and/or stool form (23 trials, 50%); often, more than one parameter was used. Stool frequency was used most often to measure diarrhea improvement (28 trials, 61%). Only one trial used a measure validated for HIV-related diarrhea. CONCLUSION: Investigators rely on non-validated and disparate measures of HIV-related diarrhea. An easy-to-use, well-accepted, and valid tool to measure HIV-related diarrhea would enhance research in this field.
Authors: Jane W Wanyiri; Henry Kanyi; Samuel Maina; David E Wang; Paul Ngugi; Roberta O'Connor; Timothy Kamau; Tabitha Waithera; Gachuhi Kimani; Claire N Wamae; Mkaya Mwamburi; Honorine D Ward Journal: Trans R Soc Trop Med Hyg Date: 2013-10 Impact factor: 2.184