Article type
Year
Abstract
Background: Retrieving appropriate adverse drug reaction data from epidemiological studies is a challenging task, even when well-established outcomes (e.g. HIT- heparin-induced thrombocytopenia) are taken into account. Lipodystrophy (LD) is a disfiguring adverse reaction to antiretroviral therapy (ART), which has been reported without consensus on the case definition.
Objectives: To estimate the frequency of LD among HIV-infected patients on ART in order to establish occurrence estimates according to diagnostic methods and case definitions reported in the literature.
Methods: A systematic review of non-randomised studies (NRS) was carried out through a sensitive search of MEDLINE, CINAHL, LILACS, EMBASE and International Pharmaceutical Abstracts databases - up to June 2014. NRS reporting LD as a primary or secondary outcome and comparing HIV-infected patients on different ART for at least six months were considered eligible. The main measure of occurrence was the incidence and prevalence of LD.
Results: Twenty studies (12 cross-sectional and eight prospective) were included in the systematic review. Most studies (80%) provided detailed information on the definition of LD, describing the anatomical sites, and four (20%) reported the outcome in vague and unspecific terms. All the studies investigated morphological alterations in the abdomen, face and limbs, and other anatomical sites. The diagnostic methods varied between studies (n = 4; 20%), with the concomitant evaluation of the physician and the patient being the most used (n = 9; 45%). Considering the reported nomenclature, the prevalence of LD ranged between 11.7% and 67.8%. The incidence of LD ranged between 8.1% and 52.0%.
Conclusions: The very heterogeneous case definitions used in the NRS precluded the establishment of point estimates of LD. Instead, we were able to provide rough interval estimates. This might be a first effort to demonstrate that: i) improvement in the reporting of LD is needed, and ii) systematic reviewers must be aware of the challenges in estimating adverse drug reactions that require better clinical definition and depend on diagnostic methods to be identified.
Objectives: To estimate the frequency of LD among HIV-infected patients on ART in order to establish occurrence estimates according to diagnostic methods and case definitions reported in the literature.
Methods: A systematic review of non-randomised studies (NRS) was carried out through a sensitive search of MEDLINE, CINAHL, LILACS, EMBASE and International Pharmaceutical Abstracts databases - up to June 2014. NRS reporting LD as a primary or secondary outcome and comparing HIV-infected patients on different ART for at least six months were considered eligible. The main measure of occurrence was the incidence and prevalence of LD.
Results: Twenty studies (12 cross-sectional and eight prospective) were included in the systematic review. Most studies (80%) provided detailed information on the definition of LD, describing the anatomical sites, and four (20%) reported the outcome in vague and unspecific terms. All the studies investigated morphological alterations in the abdomen, face and limbs, and other anatomical sites. The diagnostic methods varied between studies (n = 4; 20%), with the concomitant evaluation of the physician and the patient being the most used (n = 9; 45%). Considering the reported nomenclature, the prevalence of LD ranged between 11.7% and 67.8%. The incidence of LD ranged between 8.1% and 52.0%.
Conclusions: The very heterogeneous case definitions used in the NRS precluded the establishment of point estimates of LD. Instead, we were able to provide rough interval estimates. This might be a first effort to demonstrate that: i) improvement in the reporting of LD is needed, and ii) systematic reviewers must be aware of the challenges in estimating adverse drug reactions that require better clinical definition and depend on diagnostic methods to be identified.