Purpose Serious non-AIDS (SNA) diseases are important causes of morbidity and mortality in the HAART era. We describe development of standard criteria for 12 SNA events for Endpoint Review Committee (ERC) use in START, a multicenter international HIV clinical trial. Methods SNA definitions were developed based upon the following: (1) criteria from a previous trial (SMART), (2) review of published literature, (3) an iterative consultation and review process with the ERC and other content experts, and (4) evaluation of draft SNA criteria using retrospectively collected reports in another trial (ESPRIT). Results Final criteria are presented for acute myocardial infarction, congestive heart failure, coronary artery disease requiring drug treatment, coronary revascularization, decompensated liver disease, deep vein thrombosis, diabetes mellitus, end-stage renal disease, non-AIDS cancer, peripheral arterial disease, pulmonary embolism, and stroke. Of 563 potential SNA events reported in ESPRIT and reviewed by an ERC, 72% met “confirmed” and 13% “probable” criteria. Twenty-eight percent of cases initially reviewed by the ERC required follow-up discussion (adjudication) before a final decision was reached. Conclusion HIV clinical trials that include SNA diseases as clinical outcomes should have standardized SNA definitions to optimize event reporting and validation and should have review by an experienced ERC with opportunities for adjudication.
Purpose-Describe processes and challenges for an Endpoint Review Committee (ERC) in determining and adjudicating underlying causes of death in HIV clinical trials.Method-Three randomized HIV trials (two evaluating interleukin-2 and one treatment interruption) enrolled 11,593 persons from 36 countries during 1999-2008. Three ERC members independently reviewed each death report and supporting source documentation to assign underlying cause of death; differences of opinion were adjudicated.
IntroductionThe use of anti-retroviral therapy (ART) has dramatically reduced HIV-1 associated morbidity and mortality. However, HIV-1 infected individuals have increased rates of morbidity and mortality compared to the non-HIV-1 infected population and this appears to be related to end-organ diseases collectively referred to as Serious Non-AIDS Events (SNAEs). Circulating miRNAs are reported as promising biomarkers for a number of human disease conditions including those that constitute SNAEs. Our study sought to investigate the potential of selected miRNAs in predicting mortality in HIV-1 infected ART treated individuals.Materials and MethodsA set of miRNAs was chosen based on published associations with human disease conditions that constitute SNAEs. This case: control study compared 126 cases (individuals who died whilst on therapy), and 247 matched controls (individuals who remained alive). Cases and controls were ART treated participants of two pivotal HIV-1 trials. The relative abundance of each miRNA in serum was measured, by RTqPCR. Associations with mortality (all-cause, cardiovascular and malignancy) were assessed by logistic regression analysis. Correlations between miRNAs and CD4+ T cell count, hs-CRP, IL-6 and D-dimer were also assessed.ResultsNone of the selected miRNAs was associated with all-cause, cardiovascular or malignancy mortality. The levels of three miRNAs (miRs -21, -122 and -200a) correlated with IL-6 while miR-21 also correlated with D-dimer. Additionally, the abundance of miRs -31, -150 and -223, correlated with baseline CD4+ T cell count while the same three miRNAs plus miR-145 correlated with nadir CD4+ T cell count.DiscussionNo associations with mortality were found with any circulating miRNA studied. These results cast doubt onto the effectiveness of circulating miRNA as early predictors of mortality or the major underlying diseases that contribute to mortality in participants treated for HIV-1 infection.
Reliability of these three methods of measuring upper extremity muscle tone enhances their usefulness as well as therapists' confidence in their judicial application.
Relationships among three clinical measures of muscle tone in shoulders and wrists of patients with poststroke conditions ABSTRACT The association among three measures of muscle hypertonus were studied in shoulder internal rotation and wrist flexion on 49 poststroke subjects. Measures used were resting joint position, resistance to passive movement, and the angle at which the resistance appeared. Subjects were tested while seated with the affected arm supported and free to move in an adapted suspension armsling. Five of the six pairs of measurements (three at each joint) showed statistically significant associations with correlations between -.922 and .668 (p < .05) though the conditions under which they appeared differed. Results suggest that shoulder resting joint position and shoulder resistance to passive movernent might be used interchangeably when muscle tone is measured only or first at the shoulder joint. Patterns of correlations suggest that factors underlying resting joint position differ fundamentally from those underlying resistance to passive movement and the angle at which resistance appears. RÉSUMÉ L'association de trois mesures de l'hypertonie musculaire a été étudiée au niveau de la rotation interne de l'épaule et de la flexion du poignet chez 49 sujets atteints d'A.C.V. Les mesures utilisées étaient celle de l'articulation au repos, celle de la résistance au mouvement passif et celle de i'angle d'apparition de la résistance. Les sujets ont été évalués en position âssise, le bras affecté placé sur une suspension mobile adaptée. Des associations significatives au plan statistique avec des corrélations entre -.922 et .668 (p < .05) sont apparues dans cinq des six paires de mesures (trois à. chaque articulation), bien qu'on ait noté des différences dans les conditions de leur apparition. Les résultas suggèrent que la position de repos de l'articulation de l'épaule et la résistance de l'épaule au mouvement passif pourraient être utilisées de façon interchangeable lorsque la mesure du tonus musculaire se fait uniquement ou en premier l'articulation de l'épaule. Les modes de corrélation indiquent que les facteurs sous-jacents â. la position de repos de l'articulation diffèrent fondamentalement de ceux sous-jacents à. la résistance au mouvement passif et à. l'angle d'apparition de la résistance.
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