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Background: The minimum clinically important difference (MCID) is used to interpret the clinical relevance of results reported by trials and meta-analyses as well as to plan sample sizes in new studies. However, there is a lack of consensus about the size of MCID in acute pain, which is a core symptom affecting patients across many clinical conditions.Methods: We identified and systematically reviewed empirical studies of MCID in acute pain. We searched PubMed, EMBASE and Cochrane Library, and included prospective studies determining MCID using a patient-reported anchor and a one-dimensional pain scale (e.g. 100 mm visual analogue scale). We summarised results and explored reasons for heterogeneity applying meta-regression, subgroup analyses and individual patient data meta-analyses.Results: We included 37 studies (8479 patients). Thirty-five studies used a mean change approach, i.e. MCID was assessed as the mean difference in pain score among patients who reported a minimum degree of improvement, while seven studies used a threshold approach, i.e. MCID was assessed as the threshold in pain reduction associated with the best accuracy (sensitivity and specificity) for identifying improved patients. Meta-analyses found considerable heterogeneity between studies (absolute MCID: I2 = 93%, relative MCID: I2 = 75%) and results were therefore presented qualitatively, while analyses focused on exploring reasons for heterogeneity. The reported absolute MCID values ranged widely from 8 to 40 mm (standardised to a 100 mm scale) and the relative MCID values from 13% to 85%. From analyses of individual patient data (seven studies, 918 patients), we found baseline pain strongly associated with absolute, but not relative, MCID as patients with higher baseline pain needed larger pain reduction to perceive relief. Subgroup analyses showed that the definition of improved patients (one or several categories improvement or meaningful change) and the design of studies (single or multiple measurements) also influenced MCID values.Conclusions: The MCID in acute pain varied greatly between studies and was influenced by baseline pain, definitions of improved patients and study design. MCID is context-specific and potentially misguiding if determined, applied or interpreted inappropriately. Explicit and conscientious reflections on the choice of a reference value are required when using MCID to classify research results as clinically important or trivial. [ABSTRACT FROM AUTHOR]

Background: Quality of life of patients is an important element in the evaluation of outcome of health care, social services and clinical trials. The WHOQOL instruments were originally developed for measurement of quality of life across cultures. However, there were concerns raised about the cross-cultural equivalence of the WHOQOL-HIV when used among people with HIV in Ethiopia. Therefore, this study aimed at adapting the WHOQOL-HIV bref for the Ethiopian setting. Methods: A step-wise adaptation of the WHOQOL-HIV bref for use in Ethiopia was conducted to produce an Ethiopian version--WHOQOL-HIV-BREF-Eth. Semantic and item equivalence was tested on 20 people with HIV. One hundred people with HIV were interviewed to test for measurement equivalence (known group validity and internal consistency) of the WHOQOL-HIV-BREF-Eth. Confirmatory factor analysis was conducted using data from 348 people with HIV who were recruited from HIV clinics. Results: In the process of adaptation, new items of relevance to the context were added while seven items were deleted because of problems with acceptability and poor psychometric properties. The Cronbach's á for the final tool with twenty-seven items WHOQOL-HIV-BREF-Eth was 0.93. All six domains discriminated well between symptomatic and asymptomatic people with HIV (p < 0.001). Using confirmatory factor analysis, a second order factor structure with six first order indicator factors demonstrated moderate fit to the data ((÷2 = 627.75; DF = 259; p < 0.001), CFI = 0.82, TLI = 0.77 and RMSEA = 0.064). Conclusion: The WHOQOL-HIV-BREF-Eth has been shown to be a valid measure of quality of life for use in clinical settings among people with HIV in Ethiopia. [ABSTRACT FROM AUTHOR]

Background: Studies from high-income settings show that both food insecurity and common mental disorders (CMDs) are associated with lower quality of life among people living with HIV (PLHIV). However, there is limited research among PLHIV in sub-Saharan Africa. In this study we tested the hypothesis that food insecurity and CMDs would be associated with poorer quality of life of PLHIV in Ethiopia.Methods: A cross-sectional study was carried out with 348 PLHIV who were initiating antiretroviral therapy recruited from two primary care centers and a tertiary Hospital in southwest Ethiopia. Food insecurity, CMD, and quality of life were measured using instruments adapted and validated in Ethiopia (Household Food Insecurity Access Scale, Kessler-6, and WHOQOL-HIV-BREF-ETH, respectively). Multiple linear regression analysis was used to identify factors associated with quality of life after adjusting for confounders.Results: The prevalence of severe household food insecurity among PLHIV was 38.7 %. After adjusting for confounders, severe food insecurity (β = -3.24, 95 % CI: -6.19; -0.29) and higher levels of CMD symptoms (β = -1.72 for each 1 point increase, 95 % CI: -1.94; -1.49) were associated with lower quality of life. Other factors associated with lower quality of life were advanced HIV disease (β = -3.80, 95 % CI: -6.18; -1.42), and being underweight (BMI = 17.0 - 18.5 kg/m(2)) (β = -3.45, 95 % CI: -6.18; -0.71). Owning more household assets was associated with higher quality of life (β = 0.99 for owning one more asset, 95 % CI: 0.09; 1.89).Conclusion: Poor mental health and food insecurity are associated with lower quality of life in PLHIV. There is a need for longitudinal studies to elucidate the pathways linking CMD, food insecurity and quality of life. [ABSTRACT FROM AUTHOR]

Background The ongoing scale-up of antiretroviral therapy (ART) in sub-Saharan Africa has prompted the interest in surveillance of transmitted and acquired HIV drug resistance. Resistance data on virological failure and mutations in HIV infected populations initiating treatment in sub- Saharan Africa is sparse. Methods HIV viral load (VL) and resistance mutations pre-ART and after 6 months were determined in a prospective cohort study of ART-naïve HIV patients initiating first-line therapy in Jimma, Ethiopia. VL measurements were done at baseline and after 3 and 6 months. Genotypic HIV drug resistance (HIVDR) was performed on patients exhibiting virological failure (>1000 copies/mL at 6 months) or slow virological response (>5000 copies/mL at 3 months and <1000 copies/mL at 6 months). Results Two hundred sixty five patients had VL data available at baseline and at 6 months. Virological failure was observed among 14 (5.3%) participants out of 265 patients. Twelve samples were genotyped and six had HIV drug resistance (HIVDR) mutations at baseline. Among virological failures, 9/11 (81.8%) harbored one or more HIVDR mutations at 6 months. The most frequent mutations were K103N and M184VI. Conclusions Our data confirm that the currently recommended first-line ART regimen is efficient in the vast majority of individuals initiating therapy in Jimma, Ethiopia eight years after the introduction of ART. However, the documented occurrence of transmitted resistance and accumulation of acquired HIVDR mutations among failing patients justify increased vigilance by improving the availability and systematic use of VL testing to monitor ART response, and underlines the need for rapid, inexpensive tests to identify the most common drug resistance mutations. [ABSTRACT FROM AUTHOR]