Trial reportDrugs & aging2022
Assessment of Comorbidity Burden and Treatment Response: Reanalysis of the SCD-HEFT Trial.
Trial report in Drugs & aging, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper, 1 of them a synthesis that pooled it.
What it found
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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
1 citing paper in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.
- Prevalence and representation of comorbidities and multimorbidity in randomised controlled trials in sepsis or septic shock: a systematic review.Critical care (London, England) · 2026Pooled it
Corrections and comments
- Erratum issued
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionComorbidity burden may be associated with treatment-effect heterogeneity (HTE) in clinical trials, which could alter the interpretation or clinical translation of results for many patients in the real world.
objectiveIn this analysis, we sought to determine the distribution of multimorbidity scores in patients enrolled in SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) and tested the association between comorbidity burden and treatment efficacy for the outcome of all-cause death.
methodsEach patient was assigned a modified Charlson Comorbidity Index (mCCI) score from 1 to 14 based on available enrollment data. We investigated the relationship between mCCI score and time to all-cause death using Cox proportional hazards models. Models were fit for quartiles of the comorbidity index, reference coding was used, with quartile 1 (Q1; mCCI score of 1-2) selected as the reference. Hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) were reported from these models. Following the same analysis framework as the original manuscript, patients assigned to amiodarone or implantable cardioverter-defibrillator (ICD) were compared with those assigned to placebo in separate Cox models. Each model included the mCCI score in quartiles, group assignment, and an interaction term for the quartile and group assignment. HRs and corresponding 97.5% CIs were reported from these models.
resultsThe majority of patients had an mCCI score ≤5 (75.4%), and mortality risk was associated with increasing score. The HRs for Q2 (score 3), Q3 (scores 4-5), and Q4 (scores ≥6) were 1.46 (97.5% CI 1.06-1.99), 3.03 (97.5% CI 2.35-3.90), and 4.51 (97.5% CI 3.46-5.88), respectively. For the subgroup analysis, amiodarone was not associated with a significant difference compared with placebo for individuals in Q1-Q3; however, it was associated with an increase in death for those in Q4 (HR 1.50; 97.5% CI 1.03-2.18). ICD was associated with a significant reduction in death compared with placebo for individuals in Q1 and Q3 (HR 0.42; 97.5% CI 0.20-0.84 and HR 0.70; 97.5% CI 0.50-0.97, respectively) but not for those in Q2 or Q4. Interaction testing across subgroups suggested HTE for amiodarone (p = 0.07) and ICD (p = 0.08) versus placebo across mCCI quartiles.
conclusionsIncreasing comorbidity burden was associated with HTE when evaluating amiodarone and ICD compared with placebo in the SCD-HeFT trial. Our results highlight the importance of enrolling diverse patient populations in clinical trials and considering the possibility of HTE when translating results to clinical practice.
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