HIV Pre-Exposure Prophylaxis (PrEP)—A Quantitative Ethics Appraisal

Background: There is now strong evidence that preventive oral antiretroviral therapy can moderately reduce likelihood of HIV infection. This concept is called HIV pre-exposure prophylaxis (PrEP). Premature closures of some previous PrEP clinical trials, secondary to ethical concerns, did not stop research. We aimed to appraise the extent of ethics considerations reporting in PrEP study documents. Methods: We conducted a systematic quantitative ethics appraisal, grounded in PrEP literature and using eight principles proposed by Ezechiel Emanuel. We developed an a priori checklist of 101 evidence-based ethics items. We obtained protocols for eleven of nineteen clinical controlled studies identified. Two reviewers independently appraised study documents against the checklist. Ethics appraisal was synthesized using adjusted percentages of items reported. Results: On average, 58 % of the 101 ethics items were mentioned or addressed in documents, with variations noted both across studies and across principles. Considerations pertaining to social value were least reported (43 % of checklist items, on average) whereas considerations related to informed consent and favorable risk-benefit ratio were most reported (75 % of checklist items, on average). Discussion: Some PrEP studies reportedly address more ethics considerations than others but, overall, ethics considerations reporting could be much improved. While this review does not allow us to comment on the actual execution of HIV PrE

Accommodating quality and service improvement research within existing ethical principles

Funds were provided by a Canadian Institute of Health Research grant (Nominated PI: Monica Taljaard, PJT – 153045). Funds were also generously provided by Charles Weijer, who is funded by a Tier 1 Canadian Research Chair.Peer reviewedPublisher PD

Can patient decision aids help people make good decisions about participating in clinical trials? A study protocol

<p>Abstract</p> <p>Background</p> <p>Evidence shows that the standard process for obtaining informed consent in clinical trials can be inadequate, with study participants frequently not understanding even basic information fundamental to giving informed consent. Patient decision aids are effective decision support tools originally designed to help patients make difficult treatment or screening decisions. We propose that incorporating decision aids into the informed consent process will improve the extent to which participants make decisions that are informed and consistent with their preferences. A mixed methods study will test this proposal.</p> <p>Methods</p> <p>Phase one of this project will involve assessment of a stratified random sample of 50 consent documents from recently completed investigator-initiated clinical trials, according to existing standards for supporting good decision making. Phase two will involve interviews of a purposive sample of 50 trial participants (10 participants from each of five different clinical areas) about their experience of the informed consent process, and how it could be improved. In phase three, we will convert consent forms for two completed clinical trials into decision aids and pilot test these new tools using a user-centered design approach, an iterative development process commonly employed in computer usability literature. In phase four, we will conduct a pilot observational study comparing the new tools to standard consent forms, with potential recruits to two hypothetical clinical trials. Outcomes will include knowledge of key aspects of the decision, knowledge of the probabilities of different outcomes, decisional conflict, the hypothetical participation decision, and qualitative impressions of the experience.</p> <p>Discussion</p> <p>This work will provide initial evidence about whether a patient decision aid can improve the informed consent process. The larger goal of this work is to examine whether study recruitment can be improved from (barely) informed consent based on disclosure-oriented documents, towards a process of high-quality participant decision-making.</p

a systematic review

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.OBJECTIVES: Current guidelines do not recommend direct oral anticoagulants (DOACs) to treat cerebral venous thrombosis (CVT) despite their benefits over standard therapy. We performed a systematic review to summarise the published experience of DOAC therapy in CVT. DATA SOURCES: MEDLINE, Embase and COCHRANE databases up to 18 November 2020. ELIGIBILITY CRITERIA: All published articles of patients with CVT treated with DOAC were included. Studies without follow-up information were excluded. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers screened articles and extracted data. A risk of bias analysis was performed. PRIMARY AND SECONDARY OUTCOME MEASURES: Safety data included mortality, intracranial haemorrhage (ICH) or other adverse events. Efficacy data included recurrent CVT, recanalisation rates and disability by modified Rankin Scales (mRS). RESULTS: 33 studies met inclusion criteria. One randomised controlled trial, 5 observational cohorts and 27 case series or studies reported 279 patients treated with DOAC for CVT: 41% dabigatran, 47% rivaroxaban, 10% apixaban and 2% edoxaban, in addition to 315 patients treated with standard therapy. The observational cohorts showed a similar risk of death in DOAC and standard therapy arms (RR 2.12, 95% CI 0.29 to 15.59). New ICH was reported in 2 (0.7%) DOAC-treated patients and recurrent CVT occurred in 4 (1.5%). A favourable mRS between 0 and 2 was reported in 94% of DOAC-treated patients, more likely than standard therapy in observational cohorts (RR 1.13, 95% CI 1.02 to 1.25). CONCLUSION: The evidence for DOAC use in CVT is limited although suggests sufficient safety and efficacy despite variability in timing and dose of treatment. This systematic review highlights that further rigorous trials are needed to validate these findings and to determine optimal treatment regimens.publishersversionpublishe

Describing the content of trial recruitment interventions using the TIDieR Reporting Checklist : A systematic methodology review

Peer reviewe

Mechanisms of Unexplained Anemia in the Nursing Home

To characterize anemia in elderly nursing home residents. Design : Prospective multiinstitutional cohort study. Setting : Five nursing homes. Participants : From retrospective analysis, residents found to be anemic using chart review were prospectively randomized. Of the 81 residents enrolled, 60 were anemic. Measurements : Chart review for medical history and factors related to treatment or history of anemia, extensive laboratory evaluation for causes of anemia, and classification of anemia by two hematologists. Results : Among the 60 anemic residents, the causes of anemia were idiopathic (n=27), iron-deficiency (n=14), anemia associated with chronic disease (n=8), anemia of renal insufficiency (n=6), and other (n=5). The eryrthropoietin (EPO) response to anemia was lower in residents with idiopathic anemia (IA) than in those with iron-deficiency anemia, and this correlated with renal function as estimated using calculated creatinine clearance. In this elderly population, advancing age was not correlated with lower EPO response. Conclusion : IA is common in nursing home residents. A lower EPO response contributes to the high prevalence of anemia in this setting and may be due, in part, to occult renal dysfunction.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/65745/1/j.1532-5415.2004.52116.x.pd