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Article ; Online: Assessing efficacy in non-inferiority trials with non-adherence to interventions: Are intention-to-treat and per-protocol analyses fit for purpose?

Dodd, Matthew / Carpenter, James / Thompson, Jennifer A / Williamson, Elizabeth / Fielding, Katherine / Elbourne, Diana

2024 Volume 43, Issue 12, Page(s) 2314–2331

Abstract: Background: Non-inferiority trials comparing different active drugs are often subject to treatment non-adherence. Intention-to-treat (ITT) and per-protocol (PP) analyses have been advocated in such studies but are not guaranteed to be unbiased in the ... ...

Abstract	Background: Non-inferiority trials comparing different active drugs are often subject to treatment non-adherence. Intention-to-treat (ITT) and per-protocol (PP) analyses have been advocated in such studies but are not guaranteed to be unbiased in the presence of differential non-adherence. Methods: The REMoxTB trial evaluated two 4-month experimental regimens compared with a 6-month control regimen for newly diagnosed drug-susceptible TB. The primary endpoint was a composite unfavorable outcome of treatment failure or recurrence within 18 months post-randomization. We conducted a simulation study based on REMoxTB to assess the performance of statistical methods for handling non-adherence in non-inferiority trials, including: ITT and PP analyses, adjustment for observed adherence, multiple imputation (MI) of outcomes, inverse-probability-of-treatment weighting (IPTW), and a doubly-robust (DR) estimator. Results: When non-adherence differed between trial arms, ITT, and PP analyses often resulted in non-trivial bias in the estimated treatment effect, which consequently under- or over-inflated the type I error rate. Adjustment for observed adherence led to similar issues, whereas the MI, IPTW and DR approaches were able to correct bias under most non-adherence scenarios; they could not always eliminate bias entirely in the presence of unobserved confounding. The IPTW and DR methods were generally unbiased and maintained desired type I error rates and statistical power. Conclusions: When non-adherence differs between trial arms, ITT and PP analyses can produce biased estimates of efficacy, potentially leading to the acceptance of inferior treatments or efficacious regimens being missed. IPTW and the DR estimator are relatively straightforward methods to supplement ITT and PP approaches.
MeSH term(s)	Humans ; Intention to Treat Analysis ; Computer Simulation ; Equivalence Trials as Topic ; Medication Adherence/statistics & numerical data ; Antitubercular Agents/therapeutic use ; Antitubercular Agents/administration & dosage ; Tuberculosis/drug therapy ; Treatment Outcome ; Bias ; Models, Statistical
Language	English
Publishing date	2024-04-01
Publishing country	England
Document type	Journal Article
ZDB-ID	843037-8
ISSN	1097-0258 ; 0277-6715
ISSN (online)	1097-0258
ISSN	0277-6715
DOI	10.1002/sim.10067
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Article ; Online: Statistical methods for non-adherence in non-inferiority trials: useful and used? A systematic review.

Dodd, Matthew / Fielding, Katherine / Carpenter, James R / Thompson, Jennifer A / Elbourne, Diana

BMJ open

2022 Volume 12, Issue 1, Page(s) e052656

Abstract: Background: In non-inferiority trials with non-adherence to interventions (or non-compliance), intention-to-treat and per-protocol analyses are often performed; however, non-random non-adherence generally biases these estimates of efficacy.: Objective! ...

Abstract	Background: In non-inferiority trials with non-adherence to interventions (or non-compliance), intention-to-treat and per-protocol analyses are often performed; however, non-random non-adherence generally biases these estimates of efficacy. Objective: To identify statistical methods that adjust for the impact of non-adherence and thus estimate the causal effects of experimental interventions in non-inferiority trials. Design: A systematic review was conducted by searching the Ovid MEDLINE database (31 December 2020) to identify (1) randomised trials with a primary analysis for non-inferiority that applied (or planned to apply) statistical methods to account for the impact of non-adherence to interventions, and (2) methodology papers that described such statistical methods and included a non-inferiority trial application. Outcomes: The statistical methods identified, their impacts on non-inferiority conclusions, and their advantages/disadvantages. Results: A total of 24 papers were included (4 protocols, 13 results papers and 7 methodology papers) reporting relevant methods on 26 occasions. The most common were instrumental variable approaches (n=9), including observed adherence as a covariate within a regression model (n=3), and modelling adherence as a time-varying covariate in a time-to-event analysis (n=3). Other methods included rank preserving structural failure time models and inverse-probability-of-treatment weighting. The methods identified in protocols and results papers were more commonly specified as sensitivity analyses (n=13) than primary analyses (n=3). Twelve results papers included an alternative analysis of the same outcome; conclusions regarding non-inferiority were in agreement on six occasions and could not be compared on six occasions (different measures of effect or results not provided in full). Conclusions: Available statistical methods which attempt to account for the impact of non-adherence to interventions were used infrequently. Therefore, firm inferences about their influence on non-inferiority conclusions could not be drawn. Since intention-to-treat and per-protocol analyses do not guarantee unbiased conclusions regarding non-inferiority, the methods identified should be considered for use in sensitivity analyses. Prospero registration number: CRD42020177458.
MeSH term(s)	Bias ; Humans
Language	English
Publishing date	2022-01-12
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Systematic Review
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2021-052656
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Article ; Online: Effect of PCI on Health Status in Ischemic Left Ventricular Dysfunction: Insights From REVIVED-BCIS2.

Ryan, Matthew / Taylor, Dylan / Dodd, Matthew / Spertus, John A / Kosiborod, Mikhail N / Shaukat, Aadil / Docherty, Kieran F / Clayton, Tim / Perera, Divaka / Petrie, Mark C

JACC. Heart failure

2024

Abstract: Background: In the REVIVED-BCIS2 (Revascularization for Ischemic Ventricular Dysfunction) trial, percutaneous coronary intervention (PCI) did not reduce the incidence of death or hospitalization for heart failure (HHF).: Objectives: This prespecified ...

Abstract	Background: In the REVIVED-BCIS2 (Revascularization for Ischemic Ventricular Dysfunction) trial, percutaneous coronary intervention (PCI) did not reduce the incidence of death or hospitalization for heart failure (HHF). Objectives: This prespecified secondary analysis investigated the effect of PCI on health status measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) combined with the primary outcome in a win ratio. Methods: Participants with severe ischemic left ventricular dysfunction were randomized to either PCI in addition to optimal medical therapy (OMT) (PCI) or OMT alone (OMT). The primary outcome was a hierarchical composite of all-cause death, HHF, and KCCQ-Overall Summary Score (OSS) at 24 months analyzed using the unmatched win ratio. The key secondary endpoint was a KCCQ-OSS responder analysis. Results: A total of 347 participants were randomized to PCI and 353 to OMT. Median age was 70.0 years (Q1-Q3: 63.3-76.1 years). Mean left ventricular ejection fraction was 27.0 ± 6.7%. PCI did not improve the primary endpoint (win ratio for PCI vs OMT: 1.05; 95% CI: 0.88-1.26; P = 0.58). PCI resulted in more KCCQ-OSS responders than OMT at 6 months (54.1% vs 40.7%; OR: 1.96; 95% CI: 1.41-2.71; P < 0.001) and fewer deteriorators (25.2% vs 31.4%; OR: 0.69; 95% CI: 0.47-1.00; P = 0.048). PCI did not impact KCCQ-OSS responders or deteriorators at 12 or 24 months. Conclusions: PCI did not improve the hierarchical composite of death, HHF, and health status at 2 years. PCI improved KCCQ-OSS at 6 months, but this benefit was not sustained to 1- or 2-year follow-up. (Revacularization for Ischemic Ventricular Dysfunction [REVIVED-BCIS2]; NCT01920048).
Language	English
Publishing date	2024-04-08
Publishing country	United States
Document type	Journal Article
ZDB-ID	2705621-1
ISSN	2213-1787 ; 2213-1779
ISSN (online)	2213-1787
ISSN	2213-1779
DOI	10.1016/j.jchf.2024.03.010
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Article ; Online: Is positive school climate associated with better adolescent mental health? Longitudinal study of young people in England.

Leurent, Baptiste / Dodd, Matthew / Allen, Elizabeth / Viner, Russell / Scott, Stephen / Bonell, Chris

SSM. Mental health

2021 Volume 1, Page(s) None

Abstract: Background and objectives: Studies suggest that individual student-reported connection to school is associated with better mental health. However, there is less evidence for associations between schools' overall school climate and the mental health of ... ...

Abstract	Background and objectives: Studies suggest that individual student-reported connection to school is associated with better mental health. However, there is less evidence for associations between schools' overall school climate and the mental health of their students. This may reflect limitations in which mental health outcomes have been examined. We conducted a large longitudinal study in schools, hypothesising that we would find associations at both the student and school levels between student-reported positive school climate, and reduced student conduct and emotional problems and improved mental wellbeing. Methods: We tracked students in 20 English secondary schools from near the end of the first year of secondary school (age 11/12) over 3 years using reliable measures of school climate and mental health. Results: We found associations between student-level reports of positive school climate at baseline, and reduced conduct and emotional problems and better mental wellbeing at 3-year follow-up adjusting for various potential confounders. We also found some evidence of adjusted associations between baseline school-level measures of overall positive climate and better student mental health at follow-up. However, these student- and school-level associations reduced considerably when also adjusting for baseline mental health. Conclusions: Our findings suggest that there are associations between school climate and student mental health at both the student and school level but these associations are complex and not necessarily causal.
Language	English
Publishing date	2021-12-20
Publishing country	England
Document type	Journal Article
ISSN	2666-5603
ISSN (online)	2666-5603
DOI	10.1016/j.ssmmh.2021.100033
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Article ; Online: Metabolically diverse primordial microbial communities in Earth's oldest seafloor-hydrothermal jasper.

Papineau, Dominic / She, Zhenbing / Dodd, Matthew S / Iacoviello, Francesco / Slack, John F / Hauri, Erik / Shearing, Paul / Little, Crispin T S

Science advances

2022 Volume 8, Issue 15, Page(s) eabm2296

Abstract: The oldest putative fossils occur as hematite filaments and tubes in jasper-carbonate banded iron formations from the 4280- to 3750-Ma Nuvvuagittuq Supracrustal Belt, Québec. If biological in origin, these filaments might have affinities with modern ... ...

Abstract	The oldest putative fossils occur as hematite filaments and tubes in jasper-carbonate banded iron formations from the 4280- to 3750-Ma Nuvvuagittuq Supracrustal Belt, Québec. If biological in origin, these filaments might have affinities with modern descendants; however, if abiotic, they could indicate complex prebiotic forms on early Earth. Here, we report images of centimeter-size, autochthonous hematite filaments that are pectinate-branching, parallel-aligned, undulated, and containing Fe
Language	English
Publishing date	2022-04-13
Publishing country	United States
Document type	Journal Article
ZDB-ID	2810933-8
ISSN	2375-2548 ; 2375-2548
ISSN (online)	2375-2548
ISSN	2375-2548
DOI	10.1126/sciadv.abm2296
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Article ; Online: Cost-effectiveness of short, oral treatment regimens for rifampicin resistant tuberculosis.

Sweeney, Sedona / Berry, Catherine / Kazounis, Emil / Motta, Ilaria / Vassall, Anna / Dodd, Matthew / Fielding, Katherine / Nyang'wa, Bern-Thomas

PLOS global public health

2022 Volume 2, Issue 12, Page(s) e0001337

Abstract: Current options for treating tuberculosis (TB) that is resistant to rifampicin (RR-TB) are few, and regimens are often long and poorly tolerated. Following recent evidence from the TB-PRACTECAL trial countries are considering programmatic uptake of 6- ... ...

Abstract	Current options for treating tuberculosis (TB) that is resistant to rifampicin (RR-TB) are few, and regimens are often long and poorly tolerated. Following recent evidence from the TB-PRACTECAL trial countries are considering programmatic uptake of 6-month, all-oral treatment regimens. We used a Markov model to estimate the incremental cost-effectiveness of three regimens containing bedaquiline, pretomanid and linezolid (BPaL) with and without moxifloxacin (BPaLM) or clofazimine (BPaLC) compared with the current mix of long and short standard of care (SOC) regimens to treat RR-TB from the provider perspective in India, Georgia, Philippines, and South Africa. We estimated total costs (2019 USD) and disability-adjusted life years (DALYs) over a 20-year time horizon. Costs and DALYs were discounted at 3% in the base case. Parameter uncertainty was tested with univariate and probabilistic sensitivity analysis. We found that all three regimens would improve health outcomes and reduce costs compared with the current programmatic mix of long and short SOC regimens in all four countries. BPaL was the most cost-saving regimen in all countries, saving $112-$1,173 per person. BPaLM was the preferred regimen at a willingness to pay per DALY of 0.5 GDP per capita in all settings. Our findings indicate BPaL-based regimens are likely to be cost-saving and more effective than the current standard of care in a range of settings. Countries should consider programmatic uptake of BPaL-based regimens.
Language	English
Publishing date	2022-12-07
Publishing country	United States
Document type	Journal Article
ISSN	2767-3375
ISSN (online)	2767-3375
DOI	10.1371/journal.pgph.0001337
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Article ; Online: The Impact of the Covid-19 Pandemic on Recovery from Cardiac Surgery Over Time: Results of the Cardiaccovid Study from three Uk National Lockdowns.

Sanders, Julie / Beaumont, Emma / Dodd, Matthew / Murray, Sarah E / Owens, Gareth / Berry, Alan / Hyde, Edward / Bueser, Teofila / Clayton, Tim / Oo, Aung Ye

European journal of cardiovascular nursing

2023

Abstract: This prospective study (clinicaltrials.gov NCT04366167) explores health-related quality of life (EQ-5D-5L), event-related distress (IES-R) and depression (CES-D) after cardiac surgery during the three UK national COVID-19 lockdowns. Overall, 253 patients ...

Abstract	This prospective study (clinicaltrials.gov NCT04366167) explores health-related quality of life (EQ-5D-5L), event-related distress (IES-R) and depression (CES-D) after cardiac surgery during the three UK national COVID-19 lockdowns. Overall, 253 patients participated (lockdown one n = 196; two n = 45; three n = 12) completing the above-mentioned questionnaires at baseline, one week after discharge and six weeks, six and 12 months after surgery. While EQ-5D-5L values were similar across all cohorts, those having surgery in lockdowns two and three had higher IES-R scores at 1-year and higher IES-R and CES-D baseline scores, respectively. Generally, increased distress, worse depression and poorer HRQoL were observed in women.
Language	English
Publishing date	2023-08-16
Publishing country	England
Document type	Journal Article
ZDB-ID	2151245-0
ISSN	1873-1953 ; 1474-5151
ISSN (online)	1873-1953
ISSN	1474-5151
DOI	10.1093/eurjcn/zvad084
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Article ; Online: Exaggerated elastin turnover in young individuals with Marfan syndrome: new insights from the AIMS trial.

Iskandar, Zaid / Dodd, Matthew / Huang, Jeffrey / Chin, Calvin W L / Stuart, Graham / Caputo, Massimo / Clayton, Tim / Child, Anne / Jin, Xu Yu / Aragon-Martin, José Antonio / Gibb, Jack / Flather, Marcus / Choy, Anna-Maria

European heart journal open

2023 Volume 3, Issue 5, Page(s) oead095

Abstract: Aims: The fragmentation and loss of elastic fibre in the tunica media of the aorta are pathological hallmarks of Marfan syndrome (MFS) but the dynamics of elastin degradation and its relationship to aortic size and physiological growth remain poorly ... ...

Abstract	Aims: The fragmentation and loss of elastic fibre in the tunica media of the aorta are pathological hallmarks of Marfan syndrome (MFS) but the dynamics of elastin degradation and its relationship to aortic size and physiological growth remain poorly understood. Methods and results: In this Conclusion: This study has shown that developmental age has a significant effect on levels of elastin turnover as measured by pDES in MFS individuals as well as healthy controls. This effect is exaggerated in those with MFS with increased levels seen during the period of physiologic development that plateaus towards adulthood. This suggests an early onset of pathophysiology that may present an important opportunity for disease-modifying intervention.
Language	English
Publishing date	2023-10-09
Publishing country	England
Document type	Journal Article
ISSN	2752-4191
ISSN (online)	2752-4191
DOI	10.1093/ehjopen/oead095
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Article ; Online: Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction: Cost-Effectiveness Analysis of the REVIVED-BCIS2 Trial.

Chivardi, Carlos / Morgan, Holly / Sculpher, Mark J / Clayton, Tim / Evans, Richard / Dodd, Matthew / Petrie, Mark / Rinaldi, Christopher A / O'Kane, Peter / Brown, Louise / Perera, Divaka / Saramago, Pedro

Circulation. Cardiovascular quality and outcomes

2023 Volume 17, Issue 1, Page(s) e010533

Abstract: Background: Percutaneous coronary intervention (PCI) is frequently undertaken in patients with ischemic left ventricular systolic dysfunction. The REVIVED (Revascularization for Ischemic Ventricular Dysfunction)-BCIS2 (British Cardiovascular Society-2) ... ...

Abstract	Background: Percutaneous coronary intervention (PCI) is frequently undertaken in patients with ischemic left ventricular systolic dysfunction. The REVIVED (Revascularization for Ischemic Ventricular Dysfunction)-BCIS2 (British Cardiovascular Society-2) trial concluded that PCI did not reduce the incidence of all-cause death or heart failure hospitalization; however, patients assigned to PCI reported better initial health-related quality of life than those assigned to optimal medical therapy (OMT) alone. The aim of this study was to assess the cost-effectiveness of PCI+OMT compared with OMT alone. Methods: REVIVED-BCIS2 was a prospective, multicenter UK trial, which randomized patients with severe ischemic left ventricular systolic dysfunction to either PCI+OMT or OMT alone. Health care resource use (including planned and unplanned revascularizations, medication, device implantation, and heart failure hospitalizations) and health outcomes data (EuroQol 5-dimension 5-level questionnaire) on each patient were collected at baseline and up to 8 years post-randomization. Resource use was costed using publicly available national unit costs. Within the trial, mean total costs and quality-adjusted life-years (QALYs) were estimated from the perspective of the UK health system. Cost-effectiveness was evaluated using estimated mean costs and QALYs in both groups. Regression analysis was used to adjust for clinically relevant predictors. Results: Between 2013 and 2020, 700 patients were recruited (mean age: PCI+OMT=70 years, OMT=68 years; male (%): PCI+OMT=87, OMT=88); median follow-up was 3.4 years. Over all follow-ups, patients undergoing PCI yielded similar health benefits at higher costs compared with OMT alone (PCI+OMT: 4.14 QALYs, £22 352; OMT alone: 4.16 QALYs, £15 569; difference: -0.015, £6782). For both groups, most health resource consumption occurred in the first 2 years post-randomization. Probabilistic results showed that the probability of PCI being cost-effective was 0. Conclusions: A minimal difference in total QALYs was identified between arms, and PCI+OMT was not cost-effective compared with OMT, given its additional cost. A strategy of routine PCI to treat ischemic left ventricular systolic dysfunction does not seem to be a justifiable use of health care resources in the United Kingdom. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01920048.
MeSH term(s)	Aged ; Humans ; Male ; Coronary Artery Disease/therapy ; Cost-Effectiveness Analysis ; Heart Failure/diagnosis ; Heart Failure/therapy ; Percutaneous Coronary Intervention ; Prospective Studies ; Quality of Life ; Treatment Outcome ; Ventricular Dysfunction, Left/diagnosis ; Ventricular Dysfunction, Left/therapy ; Female
Language	English
Publishing date	2023-11-06
Publishing country	United States
Document type	Randomized Controlled Trial ; Multicenter Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2483197-9
ISSN	1941-7705 ; 1941-7713
ISSN (online)	1941-7705
ISSN	1941-7713
DOI	10.1161/CIRCOUTCOMES.123.010533
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Article ; Online: Routine cerebral embolic protection in transcatheter aortic valve implantation: rationale and design of the randomised British Heart Foundation PROTECT-TAVI trial.

Kharbanda, Rajesh K / Perkins, Alexander David / Kennedy, James / Banning, Adrian P / Baumbach, Andreas / Blackman, Daniel J / Dodd, Matthew / Evans, Richard / Hildick-Smith, David / Jamal, Zahra / Ludman, Peter / Palmer, Stephen / Stables, Rodney / Clayton, Tim

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology

2023 Volume 18, Issue 17, Page(s) 1428–1435

Abstract: Transcatheter aortic valve implantation (TAVI) is an established treatment for aortic stenosis. Cerebral embolic protection (CEP) devices may impact periprocedural stroke by capturing debris destined for the brain. However, there is a lack of high- ... ...

Abstract	Transcatheter aortic valve implantation (TAVI) is an established treatment for aortic stenosis. Cerebral embolic protection (CEP) devices may impact periprocedural stroke by capturing debris destined for the brain. However, there is a lack of high-quality randomised trial evidence supporting the use of CEP during TAVI. The British Heart Foundation (BHF) PROTECT-TAVI trial will address whether the routine use of CEP reduces the incidence of stroke in patients undergoing TAVI. BHF PROTECT-TAVI is a prospective, open-label, outcome-adjudicated, multicentre randomised controlled trial. The trial is open to all adult patients scheduled for TAVI at participating specialist cardiac centres across the United Kingdom who are able to receive the CEP device. The trial will recruit 7,730 participants. Participants will be randomised in a 1:1 ratio to undergo TAVI with CEP or TAVI without CEP (standard of care). The primary outcome is the incidence of stroke at 72 hours post-TAVI. Key secondary outcomes include the incidence of stroke and all-cause mortality up to 12 months post-TAVI, disability and cognitive outcomes, stroke severity, access site complications and a health economics analysis. The sample size of 7,730 participants has 80% power to detect a 33% relative risk reduction from a 3% incidence of the primary outcome in the controls. Trial recruitment commenced in October 2020. As of October 2022, 3,068 patients have been enrolled. BHF PROTECT-TAVI is designed to provide definitive evidence on the clinical efficacy and cost-effectiveness of using routine CEP with the SENTINEL device to reduce stroke in TAVI.
MeSH term(s)	Humans ; Transcatheter Aortic Valve Replacement/adverse effects ; Prospective Studies ; Heart ; Aortic Valve Stenosis/therapy ; Stroke/etiology ; Stroke/prevention & control ; Stroke/epidemiology ; Treatment Outcome ; Aortic Valve/surgery ; Embolic Protection Devices ; Risk Factors
Language	English
Publishing date	2023-01-27
Publishing country	France
Document type	Randomized Controlled Trial ; Multicenter Study ; Journal Article
ZDB-ID	2457174-X
ISSN	1969-6213 ; 1774-024X
ISSN (online)	1969-6213
ISSN	1774-024X
DOI	10.4244/EIJ-D-22-00713
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