A new method of applying randomised control study data to the individual patient: A novel quantitative patient-centred approach to interpreting composite end points

Ahmad, Yousif; Nijjer, Sukhjinder; Cook, Christopher; El‐Harasis, Majd A.; Graby, John; Petraco, Ricardo; Kotecha, Tushar; Baker, Christopher; Malik, Iqbal; Bellamy, Michael; Sethi, Amarjit Singh; Mikhail, Ghada; Al-Bustami, Mahmud; Khan, Masood; Kaprielian, Raffi; Foale, Rodney A.; Mayet, Jamil; Davies, Justin E.; Francis, Dárrel P.; Sen, Sayan

doi:10.1016/j.ijcard.2015.05.109

Cited by 28 publications

(30 citation statements)

References 29 publications

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“…In addition, more than half of the patients stated that the avoidance of a major stroke is more important than the avoidance of death, suggesting that patients fear a loss of their mobility and independence most of all. Our results corroborate the findings of Ahmad et al and Stolker et al who described that patients considered disabling stroke worse than death. In addition, patients place greater emphasis on avoiding a redo CABG surgery , as compared to a redo PCI procedure , and do assign different weights to CE according to severity (major/minor event).…”

Section: Discussionsupporting

confidence: 93%

“…The current study and previous research in this field suggest that this is not the case . In accordance with previous recommendations, we therefore recommend using “weighted” CE, in which individual CEs a valued relative to one another . Prior efforts to weigh these CE often assumed that patients, doctors and other experts would assign similar values to individual CEs; however, the study of Stolker et al .…”

Section: Discussionsupporting

confidence: 75%

“…The attributes included in this study were determined in a stepwise manner, which subsequently included a literature review, expert review and individual interviews with patients. First, a list of attributes that describe possible unfavourable outcomes of revascularization was compiled based on previously published literature . Second, this list of unfavourable outcomes was discussed within the steering committee of the research team (including 2 cardiologists with expertise in these interventions, and 2 senior health scientists for specialist methodological input).…”

Section: Methodsmentioning

confidence: 99%

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Are component endpoints equal? A preference study into the practice of composite endpoints in clinical trials

Vaanholt

Kok

Birgelen

et al. 2018

Health Expectations

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ObjectivesTo examine patients’ perspectives regarding composite endpoints and the utility patients put on possible adverse outcomes of revascularization procedures.DesignIn the PRECORE study, a stated preference elicitation method Best‐Worst Scaling (BWS) was used to determine patient preference for 8 component endpoints (CEs): need for redo percutaneous coronary intervention (PCI) within 1 year, minor stroke with symptoms <24 hours, minor myocardial infarction (MI) with symptoms <3 months, recurrent angina pectoris, need for redo coronary artery bypass grafting (CABG) within 1 year, major MI causing permanent disability, major stroke causing permanent disability and death within 24 hours.SettingA tertiary PCI/CABG centre.ParticipantsOne hundred and sixty patients with coronary artery disease who underwent PCI or CABG.Main outcome measuresImportance weights (IWs).ResultsPatients considered need for redo PCI within 1 year (IW: 0.008), minor stroke with symptoms <24 hours (IW: 0.017), minor MI with symptoms <3 months (IW: 0.027), need for redo CABG within 1 year (IW: 0.119), recurrent angina pectoris (IW: 0.300) and major MI causing permanent disability (IW: 0.726) less severe than death within 24 hours (IW: 1.000). Major stroke causing permanent disability was considered worse than death within 24 hours (IW: 1.209). Ranking of CEs and the relative values attributed to the CEs differed among subgroups based on gender, age and educational level.ConclusionPatients attribute different weight to individual CEs. This has significant implications for the interpretation of clinical trial data.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionsupporting

confidence: 75%

Section: Methodsmentioning

confidence: 99%

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Are component endpoints equal? A preference study into the practice of composite endpoints in clinical trials

Vaanholt

Kok

Birgelen

et al. 2018

Health Expectations

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“…Six studies 1 , 4 – 8 that met our inclusion criteria were included in the final report ( Figure 2 ). The attributes most often cited in these studies coincided with those already used in clinical trials: death, 4 , 6 – 8 stroke, 4 , 6 – 8 myocardial infarction, 4 , 7 and repeat revascularization. 1 , 6 – 8 Other attributes examined within these studies included heart attack, 6 hospitalization, 6 repeat PCI, 4 repeat CABG, 4 atrial fibrillation, 4 mediastinitis, 4 postoperative chronic pain, 1 , 4 postprocedural angina, 4 , 6 length of stay, 1 , 4 duration of recovery, 1 , 4 depression, 4 procedural cost, 4 incision scar, 1 , 4 , 5 pseudoaneurysm, 4 pneumonia, 4 long-term use of clopidogrel, 4 renal failure, 4 acute respiratory distress syndrome, 4 bleeding, 4 symptom control, medication side effects, comfort in taking medication, well-being, the ability to do things, the prolonging of life, and cure.…”

Section: Resultsmentioning

confidence: 86%

Patient and physician preferences for attributes of coronary revascularization

Magliano¹,

Monteiro

Tura³

et al. 2018

PPA

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BackgroundPatients with a diagnosis of coronary artery disease (CAD) may face important decisions regarding treatment options, with the “right choice” depending on the relative weights of risks and benefits. Studies performed as discrete choice experiments are used to estimate these weights, and attribute selection is an essential step in the design of these studies. Attributes not included in the design cannot be analyzed. In this study, we aimed to elicit, rank, and rate attributes that may be considered important to patients and physicians who must choose between angioplasty and surgery for coronary revascularization.MethodsThe elicitation process involved performing a systematic review to search for attributes cited in declared preference studies in addition to face-to-face interviews with cardiologists and experts. The interviews were audio-recorded in digital format, and the collected data were transcribed and searched to identify new attributes. The criterion used to finish the data collection process was sampling saturation.ResultsA systematic review resulted in the selection of the following 14 attributes: atrial fibrillation, heart failure, incision scar, length of stay, long-term survival, myocardial infarction, periprocedural death, postoperative infection, postprocedural angina, pseudoaneurysm, renal failure, repeat coronary artery bypass grafting, repeat percutaneous coronary intervention, and stroke. The interviews added no new attributes. After rating, we identified significant differences in the values that patients and cardiologists placed on renal insufficiency (p<0.001), periprocedural death (p<0.001), and long-term survival (p<0.001).ConclusionDecisions regarding the best treatment option for patients with CAD should be made based on differences in risk and the patient’s preference regarding the most relevant endpoints. We elicited, ranked, and rated 14 attributes related to CAD treatment options. This list of attributes may help researchers who seek to perform future preference studies of CAD treatment options.

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“…Furthermore, patients consider a stroke a worse outcome than death, 21 and the patients enrolled in these trials—and who should be considered for device therapy in clinical practice—will be young and all have made a good recovery from their index stroke. Finally, this number needed to treat quoted is per year.…”

Section: Discussionmentioning

confidence: 99%

Patent foramen ovale closure vs. medical therapy for cryptogenic stroke: a meta-analysis of randomized controlled trials

Ahmad

Howard

Arnold

et al. 2018

European Heart Journal

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AimsThe efficacy of patent foramen ovale (PFO) closure for cryptogenic stroke has been controversial. We undertook a meta-analysis of randomized controlled trials (RCTs) comparing device closure with medical therapy to prevent recurrent stroke for patients with PFO.Methods and resultsWe systematically identified all RCTs comparing device closure to medical therapy for cryptogenic stroke in patients with PFO. The primary efficacy endpoint was recurrent stroke, analysed on an intention-to-treat basis. The primary safety endpoint was new onset atrial fibrillation (AF). Five studies (3440 patients) were included. In all, 1829 patients were randomized to device closure and 1611 to medical therapy. Across all patients, PFO closure was superior to medical therapy for prevention of stroke [hazard ratio (HR) 0.32, 95% confidence interval (95% CI) 0.13–0.82; P = 0.018, I2 = 73.4%]. The risk of AF was significantly increased with device closure [risk ratio (RR) 4.68, 95% CI 2.19–10.00, P<0.001, heterogeneity I2 = 27.5%)]. In patients with large shunts, PFO closure was associated with a significant reduction in stroke (HR 0.33, 95% CI 0.16–0.72; P = 0.005), whilst there was no significant reduction in stroke in patients with a small shunt (HR 0.90, 95% CI 0.50–1.60; P = 0.712). There was no effect from the presence or absence of an atrial septal aneurysm on outcomes (P = 0.994).ConclusionIn selected patients with cryptogenic stroke, PFO closure is superior to medical therapy for the prevention of further stroke: this is particularly true for patients with moderate-to-large shunts. Guidelines should be updated to reflect this.

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A new method of applying randomised control study data to the individual patient: A novel quantitative patient-centred approach to interpreting composite end points

Cited by 28 publications

References 29 publications

Are component endpoints equal? A preference study into the practice of composite endpoints in clinical trials

Are component endpoints equal? A preference study into the practice of composite endpoints in clinical trials

Patient and physician preferences for attributes of coronary revascularization

Patent foramen ovale closure vs. medical therapy for cryptogenic stroke: a meta-analysis of randomized controlled trials

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