Recommendations for analytical antiretroviral treatment interruptions in HIV research trials: report of a consensus meeting

Analytical antiretroviral treatment interruption (ATI) is an important feature of HIV research, seeking to achieve sustained viral suppression in the absence of antiretroviral therapy (ART) when the goal is to measure effects of novel therapeutic interventions on time to viral load rebound or altered viral setpoint. Trials with ATIs also intend to determine host, virological, and immunological markers that are predictive of sustained viral control off ART. Although ATI is increasingly incorporated into proof-of-concept trials, no consensus has been reached on strategies to maximise its utility and minimise its risks. In addition, differences in ATI trial designs hinder the ability to compare efficacy and safety of interventions across trials. Therefore, we held a meeting of stakeholders from many interest groups, including scientists, clinicians, ethicists, social scientists, regulators, people living with HIV, and advocacy groups, to discuss the main challenges concerning ATI studies and to formulate recommendations with an emphasis on strategies for risk mitigation and monitoring, ART resumption criteria, and ethical considerations. In this Review, we present the major points of discussion and consensus views achieved with the goal of informing the conduct of ATIs to maximise the knowledge gained and minimise the risk to participants in clinical HIV research

The Cholecystectomy As A Day Case (CAAD) Score: A Validated Score of Preoperative Predictors of Successful Day-Case Cholecystectomy Using the CholeS Data Set

Background Day-case surgery is associated with significant patient and cost benefits. However, only 43% of cholecystectomy patients are discharged home the same day. One hypothesis is day-case cholecystectomy rates, defined as patients discharged the same day as their operation, may be improved by better assessment of patients using standard preoperative variables. Methods Data were extracted from a prospectively collected data set of cholecystectomy patients from 166 UK and Irish hospitals (CholeS). Cholecystectomies performed as elective procedures were divided into main (75%) and validation (25%) data sets. Preoperative predictors were identified, and a risk score of failed day case was devised using multivariate logistic regression. Receiver operating curve analysis was used to validate the score in the validation data set. Results Of the 7426 elective cholecystectomies performed, 49% of these were discharged home the same day. Same-day discharge following cholecystectomy was less likely with older patients (OR 0.18, 95% CI 0.15–0.23), higher ASA scores (OR 0.19, 95% CI 0.15–0.23), complicated cholelithiasis (OR 0.38, 95% CI 0.31 to 0.48), male gender (OR 0.66, 95% CI 0.58–0.74), previous acute gallstone-related admissions (OR 0.54, 95% CI 0.48–0.60) and preoperative endoscopic intervention (OR 0.40, 95% CI 0.34–0.47). The CAAD score was developed using these variables. When applied to the validation subgroup, a CAAD score of ≤5 was associated with 80.8% successful day-case cholecystectomy compared with 19.2% associated with a CAAD score >5 (p < 0.001). Conclusions The CAAD score which utilises data readily available from clinic letters and electronic sources can predict same-day discharges following cholecystectomy

Perceived barriers to flexible sigmoidoscopy screening for colorectal cancer among UK ethnic minority groups: a qualitative study

&lt;p&gt;Objectives: Evidence from existing UK screening programmes indicates disparities in uptake rates between UK ethnic minorities and the white majority population. The aim of this study was to explore barriers to the uptake of flexible sigmoidoscopy (FS) screening among UK ethnic minority populations. Specifically, beliefs about bowel cancer, perceived barriers to the test and ideas about ways to increase uptake were investigated.&lt;/p&gt; &lt;p&gt;Methods: Nine focus groups were conducted with a total of 53 participants from African-Caribbean, Gujarati Indian, Pakistani and white British communities. The topic guide was based on the Health Belief Model. Discussions were subject to framework analysis.&lt;/p&gt; &lt;p&gt;Results: Most participants expressed limited awareness of bowel cancer and cited this as a barrier to screening attendance. Anxiety regarding the invasiveness of the test, the bowel preparation and fear of a cancer diagnosis were common barriers across all ethnic groups. Language difficulties, failure to meet religious sensitivities and the expression of culturally influenced health beliefs were all discussed as specific barriers to uptake. Ethnically tailored health promotion and general practitioner involvement were recommended as ways of overcoming such barriers.&lt;/p&gt; &lt;p&gt;Conclusions: The study was the first attempt to qualitatively explore barriers to FS bowel cancer screening in UK ethnic minorities. Most barriers were shared by all ethnic groups but health educators should supplement approaches designed for the majority to incorporate the specific needs of individual minority groups to ensure equitable access.&lt;/p&gt

Socioeconomic inequalities in colorectal cancer screening uptake: does time perspective play a role?

Objective: This study examined the role of time perspective in explaining inequalities in colorectal cancer screening attendance. We tested a path model predicting that (a) socioeconomic status (SES) would be associated with consideration of future consequences (CFC), (b) CFC would be associated with perceived benefits/barriers, and (c) barriers and benefits would be associated longitudinally with screening attendance. Method: Data for these analyses came from the control arm (n = 809) of an intervention to increase screening uptake. Participants between 55 and 64 years were offered screening as part of the U.K. Flexible Sigmoidoscopy (FS) Trial. They completed a questionnaire that included demographic and psychological variables. Subsequent screening attendance was recorded. Results: There was clear evidence of SES differences in attendance, with 56% in the most deprived tertile attending their FS appointment, compared with 68% in the middle tertile and 71% in the least deprived tertile (p < .01). Lower SES was associated with lower CFC, higher perceived barriers, and lower perceived benefits (p < .05 for all). Higher CFC, higher perceived benefits, and lower perceived barriers were associated with attendance (p < .01 for all). CFC mediated the association between SES and perceived benefits/barriers, while perceived benefits/barriers mediated the association between CFC and attendance. Conclusion: SES differences in CFC contribute to SES differences in the perceived barriers and benefits of screening, which, in turn, contribute to differences in attendance. Interventions that take CFC into account, for example, by emphasizing short-term benefits, could promote equality in screening participation