Trial reportAIDS (London, England)2016
The per-protocol effect of immediate versus deferred antiretroviral therapy initiation.
Trial report in AIDS (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed.
- Use of Machine Learning to Estimate the Per-Protocol Effect of Low-Dose Aspirin on Pregnancy Outcomes: A Secondary Analysis of a Randomized Clinical Trial.JAMA network open · 2022Trial
- Addressing treatment switching in the ALTA-1L trial with g-methods: exploring the impact of model specification.BMC medical research methodology · 2024Article
- Enhanced Cohort Methods for HIV Research and Epidemiology (ENCORE): Protocol for a Nationwide Hybrid Cohort for Transgender Women in the United States.JMIR research protocols · 2024Article
- Hypothetical Interventions on Cardiovascular Health Metrics for Abnormal Cognitive Aging: An Application of the Parametric g-formula in the CLHLS Cohort Study with 12 Years Follow-Up.The journal of prevention of Alzheimer's disease · 2024Article
- Estimating the per-protocol effect of lithium on suicidality in a randomized trial of individuals with depression or bipolar disorder.Journal of psychopharmacology (Oxford, England) · 2023Article
- Impact of immediate initiation of antiretroviral therapy among men who have sex with men infected with HIV in Chengdu, southwest China: trends analysis, 2008-2018.BMC public health · 2021Article
- Article
- Assessing strength of evidence for regulatory decision making in licensing: What proof do we need for observational studies of effectiveness?Pharmacoepidemiology and drug safety · 2020Article
- Defining and Identifying Per-protocol Effects in Randomized Trials.Epidemiology (Cambridge, Mass.) · 2020Article
- Effect Estimates in Randomized Trials and Observational Studies: Comparing Apples With Apples.American journal of epidemiology · 2019Article
- Estimating Human Immunodeficiency Virus (HIV) Prevention Effects in Low-incidence Settings.Epidemiology (Cambridge, Mass.) · 2019Article
- Generalizing the per-protocol treatment effect: The case of ACTG A5095.Clinical trials (London, England) · 2019Article
- A review of time scale fundamentals in the g-formula and insidious selection bias.Current epidemiology reports · 2018Article
- Comparing the Effectiveness of Dynamic Treatment Strategies Using Electronic Health Records: An Application of the Parametric g-Formula to Anemia Management Strategies.Health services research · 2018Article
- Serious Non-AIDS Conditions in HIV: Benefit of Early ART.Current HIV/AIDS reports · 2018Review
- Using Observational Data to Calibrate Simulation Models.Medical decision making : an international journal of the Society for Medical Decision Making · 2018Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
Abstract
objectiveThe Strategic Timing of AntiRetroviral Treatment (START) trial found a lower risk of a composite clinical outcome in HIV-positive individuals assigned to immediate initiation of antiretroviral therapy (ART) compared with those assigned to deferred initiation. However, 30% of those assigned to deferred initiation started ART earlier than the protocol specified. To supplement the published intention-to-treat (ITT) effect estimates, here we estimate the per-protocol effect of immediate versus deferred ART initiation in START.
designThe START trial randomized 4685 HIV-positive participants with CD4 cell counts more than 500 cells/μl to start ART immediately after randomization (immediate initiation group) or to wait until the CD4 cell count dropped below 350 cells/μl or an AIDS diagnosis (deferred initiation group).
methodsWe used the parametric g-formula to estimate and compare the cumulative 5-year risk of the composite clinical outcome in the immediate initiation group, and deferred initiation groups had all the trial participants adhered to the protocol.
resultsWe estimated that the 5-year risk of the composite outcome would have been 3.2% under immediate ART initiation and 7.0% under deferred initiation. The difference of 3.8% (95% confidence interval 1.5, 6.5) was larger than the ITT effect estimate of 3.1%, corresponding to a difference in effect estimates of 0.72% (-0.35, 2.35).
conclusionThe ITT effect estimate may underestimate the benefit of immediate ART initiation by 23%. This estimate can be used by patients and policy-makers who need to understand the full extent of the benefit of changes in ART initiation policies.
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Registered trials
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