ObjectivesThere is increasing recognition that insufficient attention has been paid to the choice of outcomes measured in clinical trials. The lack of a standardized outcome classification system results in inconsistencies due to ambiguity and variation in how outcomes are described across different studies. Being able to classify by outcome would increase efficiency in searching sources such as clinical trial registries, patient registries, the Cochrane Database of Systematic Reviews, and the Core Outcome Measures in Effectiveness Trials (COMET) database of core outcome sets (COS), thus aiding knowledge discovery.Study Design and SettingA literature review was carried out to determine existing outcome classification systems, none of which were sufficiently comprehensive or granular for classification of all potential outcomes from clinical trials. A new taxonomy for outcome classification was developed, and as proof of principle, outcomes extracted from all published COS in the COMET database, selected Cochrane reviews, and clinical trial registry entries were classified using this new system.ResultsApplication of this new taxonomy to COS in the COMET database revealed that 274/299 (92%) COS include at least one physiological outcome, whereas only 177 (59%) include at least one measure of impact (global quality of life or some measure of functioning) and only 105 (35%) made reference to adverse events.ConclusionsThis outcome taxonomy will be used to annotate outcomes included in COS within the COMET database and is currently being piloted for use in Cochrane Reviews within the Cochrane Linked Data Project. Wider implementation of this standard taxonomy in trial and systematic review databases and registries will further promote efficient searching, reporting, and classification of trial outcomes.
Objectives Mortality in young people with perinatally acquired HIV infection (PHIV) following transfer to adult care has not been characterized in the UK. We conducted a multicentre audit to establish the number of deaths and associated factors. Methods Fourteen adult clinics caring for infected young people reported deaths to 30 September 2011 on a proforma. Deaths were matched to the Collaborative HIV Paediatric Study, a clinical database of HIV‐infected children in the UK/Ireland, to describe clinical characteristics in paediatric care of those who died post‐transition. Results Eleven deaths were reported from 14 clinics which cared for 248 adults with PHIV. For the 11 deaths, the median age at transfer to adult care was 17 years (range 15–21 years), and at death was 21 years (range 17–24 years). Causes of death were suicide (two patients), advanced HIV disease (seven patients) and bronchiectasis (one patient), with one cause missing. At death, the median CD4 count was 27 cells/μL (range 0–630 cells/μL); five patients were on antiretroviral therapy (ART) but only two had a viral load < 50 HIV‐1 RNA copies/mL. Nine had poor adherence when in paediatric care, continuing into adult care despite multidisciplinary support. Eight had ART resistance, although all had potentially suppressive regimens available. Nine had mental health diagnoses. Conclusions Our findings highlight the complex medical and psychosocial issues faced by some adults with PHIV, with nine of the 11 deaths in our study being associated with poor adherence and advanced HIV disease. Novel adherence interventions and mental health support are required for this vulnerable cohort.
c Triple-site testing (using pharyngeal, rectal, and urethral/first-void urine samples) for Neisseria gonorrhoeae and Chlamydia trachomatis using nucleic acid amplification tests detects greater numbers of infections among men who have sex with men (MSM). However, triple-site testing represents a cost pressure for services. MSM over 18 years of age were eligible if they requested testing for sexually transmitted infections (STIs), reported recent sexual contact with either C. trachomatis or N. gonorrhoeae, or had symptoms of an STI. Each patient underwent standard-of-care (SOC) triple-site testing, and swabs were taken to form a pooled sample (PS) (pharyngeal, rectal, and urine specimens). The PS was created using two methods during different periods at one clinic, but we analyzed the data in combination because the sensitivity of the two methods did not differ significantly for C. trachomatis (P ؍ 0.774) or N. gonorrhoeae (P ؍ 0.163). The sensitivity of PS testing (92%) was slightly lower than that of SOC testing (96%) for detecting C. trachomatis (P ؍ 0.167). For N. gonorrhoeae, the sensitivity of PS testing (90%) was significantly lower than that of SOC testing (99%) (P < 0.001). When pharynx-only infections were excluded, the sensitivity of PS testing to detect N. gonorrhoeae infections increased to 94%. Our findings show that pooling of self-taken samples could be an effective and cost-saving method, with high negative predictive values. (Interim results of this study were presented at the BASHH 2013 summer meeting.) I n the United States and Europe, genital Chlamydia trachomatis and Neisseria gonorrhoeae are the most prevalent bacterial sexually transmitted infections (STIs). In the United Kingdom, rates of gonorrhea and chlamydia among men who have sex with men (MSM) continue to rise (1), while studies highlight increases in the numbers of HIV-positive and HIV-negative MSM reporting high-risk sexual behavior since the advent of combination antiretroviral therapy (cART) (2-4).Coinfection with an STI and HIV has been shown to increase HIV transmission in epidemiological studies (5-7). Concomitant genital infections have been shown to increase shedding of HIV in the genital tract, in both vaginal secretions and seminal fluid (8, 9). Rectal C. trachomatis/N. gonorrhoeae infections have been associated with HIV acquisition in MSM (10), and it is plausible that they may also enhance HIV transmission.Nucleic acid amplification tests (NAATs) are being used increasingly to screen MSM for pharyngeal and rectal C. trachomatis/N. gonorrhoeae infections, in addition to the use of urethral or first-void urine (FVU) samples, and the use of NAATs is now recommended in national guidelines (11). While there are no NAATs licensed for use with extragenital specimens, several studies have demonstrated that NAATs perform well for the detection of both pharyngeal and rectal C. trachomatis/N. gonorrhoeae infections in . Studies evaluating the performance of these testing methodologies have demonstrated sensitivities and sp...
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