Patient Comprehension and Reaction to Participating in a Double-blind Randomized Clinical Trial (ISIS-4) in Acute Myocardial Infarction

Yuval, Rita; Halon, David A.; Merdler, Amnon; Khader, Nader; Karkabi, Basheer; Uziel, K.; Lewis, Basil S.

doi:10.1001/archinte.160.8.1142

Cited by 85 publications

(69 citation statements)

References 33 publications

(30 reference statements)

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“…In other studies including patients with acute myocardial infarction, the rates of lack of recall were similar to our rate. However, the informed-consent procedures were performed in a more stressful and urgent condition than was our consent procedure [16,17]. In our study, as many as 25% of patients had incomplete recall of the study components.…”

Section: Discussionmentioning

confidence: 73%

Informed consent for research in ICU obtained before ICU admission

2006

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in a study, and 9/36 (25%) could not recall the study purpose and the related risk. Patients with incomplete recall stayed longer in ICU [median (range): 4 (3-6) vs 3 (1-5) days; p = 0.004]. None of these patients (0/9 vs 10/27; p < 0.04) had read the informative leaflet AND asked at least one question during the informed consent procedure. Conclusions: Even when the informed consent is obtained in the most optimal conditions for ICU research, its ethical value remains questionable. Indeed, a substantial number of patients were unaware of their study participation, or of the related purpose and risks. When the ICU stay is prolonged, we should at least repeatedly and actively (re)-inform patients about their study participation.

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Section: Discussionmentioning

confidence: 73%

Informed consent for research in ICU obtained before ICU admission

2006

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“…Verbal information is understood and retained significantly better by patients compared with written information in acute MI trials. [54][55][56] The assent procedure was successfully used in the Strategic Reperfusion Early after Myocardial Infarction (STREAM) 57 and the Reperfusion Facilitated by Local adjunctive therapy in STEMI (ReFLO-STEMI) 58 multicentre acute STEMI studies. If patients met the inclusion criteria after angiography they were asked to give further verbal assent before randomisation.…”

Section: Initial Assessment and Assentmentioning

confidence: 99%

The randomised Complete versus Lesion-only PRimary percutaneous coronary Intervention Trial: Cardiovascular Magnetic Resonance imaging substudy (CvLPRIT-CMR)

et al. 2016

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BackgroundComplete revascularisation in patients with multivessel disease who are treated with primary percutaneous coronary intervention (PPCI) may improve outcomes compared with an infarct-related artery (IRA)-only strategy. However, non-IRA percutaneous coronary intervention (PCI) may result in additional myocardial infarction (MI).ObjectivesTo determine whether or not in-hospital complete revascularisation was associated with increased total infarct size (IS) in patients participating in the Complete versus Lesion-only PPCI trial (CvLPRIT). Secondary objectives were to assess whether or not myocardial salvage index, myocardial ischaemia and final IS at follow-up were different with a complete revascularisation versus an IRA-only strategy.DesignMulticentre, prospective, randomised, controlled and open-label trial with blinded end-point analysis.SettingSeven PPCI centres in England, UK.ParticipantsST-segment elevation MI (STEMI) patients with multivessel disease (angiographic stenosis > 70% in one view or > 50% in orthogonal views) presenting within 12 hours of symptom onset and treated with the PPCI. Coronary artery bypass surgery, cardiogenic shock and contraindications to cardiovascular magnetic resonance (CMR; substudy only) imaging were exclusions.InterventionsPatients were randomised to either complete in-hospital revascularisation or an IRA-only strategy.Main outcome measuresThe primary outcome was IS as measured by CMR undertaken at 48–72 hours post PPCI. Secondary outcome measures included microvascular obstruction, myocardial salvage index, left ventricular volumes and ejection fraction and final IS on the acute and follow-up CMR carried out at 9 months post STEMI.ResultsPatients were recruited from May 2011 until May 2013 and followed up for 12 months. Of 296 patients randomised in the main CvLPRIT, 205 consented to participate in the CMR substudy and 203 had analysable images for the primary end point. Patients in the IRA-only group (n = 105) were well matched to those in the complete revascularisation group (n = 98) for all baseline characteristics {mean age 64.1 years [standard deviation (SD) 10.8 years] vs. 63.1 years (SD 11.3 years); male sex 89% vs. 79%, respectively}. Total IS was not significantly different in the IRA-only and complete revascularisation groups {median 13.5% [interquartile range (IQR) 6.2–21.9%] of left ventricular (LV) mass vs. median 12.6% (IQR 7.2–22.6%) LV mass, respectively; 95% confidence interval –4.09% to 31.17%;p = 0.57}. Myocardial salvage index was also not significantly different in the IRA-only and complete revascularisation groups [median 58.5% (IQR 32.8–74.9%) vs. median 60.5% (IQR 40.6–81.9%), respectively;p = 0.14]. The prevalence of non-IRA MI on acute CMR was higher in the complete revascularisation group than in the IRA-only group (22/98 vs. 11/105, respectively;p = 0.02). There was no difference in total IS, ischaemic burden or LV volumes between treatment groups at follow-up CMR.LimitationsThe CMR substudy population may not be a true representation of the overall study population. The optimal timing of CMR to measure IS post PPCI is uncertain. Myocardial salvage was assessable in only 70% of patients.ConclusionsMultivessel PCI, compared with an IRA-only revascularisation, in the setting of STEMI led to a small increase in CMR imaging-detected non-IRA MI, but total IS was not increased.Future workLarger studies are required to (1) confirm that death and MI are reduced by a complete revascularisation strategy; (2) assess whether or not functional assessment of non-IRA lesions results in similar outcomes to a pragmatic angiographic-based revascularisation strategy; and (3) assess the timing of in-hospital versus staged outpatient complete revascularisation.Trial registrationCurrent Controlled Trials ISRCTN70913605.FundingThis project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership. The main CvLPRIT was funded by the British Heart Foundation (SP/10/001) with support from the NIHR Comprehensive Local Research Networks.

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“…[1][2][3][4][5][6][7][8][9][10][11] A particular concern is that some patients do not have the requisite skill, numeracy, to understand and manipulate quantitative information about uncertain outcomes. For example, in a study of highly educated adults, Lipkus et al 12 found low levels of numeracy, with no more than one-third of respondents able to answer all 10 items correctly on the authors' numeracy scale.…”

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confidence: 99%

Understanding of an aggregate probability statement by patients who are offered participation in Phase I clinical trials

Weinfurt

DePuy

Castel

et al. 2004

Cancer

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BACKGROUNDThere is concern that patients with poor numeracy may have difficulty understanding the information necessary to make informed treatment decisions. The authors sought to characterize a special form of numeracy among patients with advanced cancer who were offered participation in Phase I oncology clinical trials.METHODSSurveys were administered to 328 cancer patients who were considering Phase I trials. Their frequency‐type numeracy was assessed using a multiple‐choice question involving a hypothetical scenario in which a physician stated that an experimental treatment would control cancer in “40% of cases like yours.” In univariate and multivariable analyses, patient characteristics that were associated with better numeracy were identified.RESULTSThe correct frequency‐type interpretation was selected by 72% of respondents. Fourteen percent of respondents incorrectly selected a belief‐type answer, “The doctor is 40% confident that the treatment will control my cancer.” In a multivariable model, patients who answered incorrectly tended to have less formal education and less experience with experimental therapies.CONCLUSIONSBecause the misunderstandings some patients demonstrated may influence their treatment decision making adversely, it is critical to identify such patients and to give them special consideration when communicating information about potential risks and benefits of treatment. Cancer 2004. © 2004 American Cancer Society.

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Patient Comprehension and Reaction to Participating in a Double-blind Randomized Clinical Trial (ISIS-4) in Acute Myocardial Infarction

Cited by 85 publications

References 33 publications

Informed consent for research in ICU obtained before ICU admission

Informed consent for research in ICU obtained before ICU admission

The randomised Complete versus Lesion-only PRimary percutaneous coronary Intervention Trial: Cardiovascular Magnetic Resonance imaging substudy (CvLPRIT-CMR)

Understanding of an aggregate probability statement by patients who are offered participation in Phase I clinical trials

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