a booklet on participants’ rights to improve consent for clinical research: a randomised trial

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Heart, Lung and Circulation Abstracts 5512013;22:548–593 CSANZ 2013 NZ Abstracts

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PFO Closure – The Christchurch Experience

P.J.P. Balfour ∗, D. Murphy, R.W. Troughton, J.W.H. Blake

Cardiology Department, Christchurch Public Hospital, Canter-bury District Health Board, New Zealand

Background: Percutaneous Patent Foramen Ovale (PFO)closure may reduce the risk of recurrent cryptogenic strokefrom paradoxical embolism in selected patients. Recentlypublished randomised controlled trials do not show signif-icant benefit over maximal medical treatment. We reportthe safety and efficacy of PFO closure in Christchurch.

Methods: All patients who underwent PFO closure atChristchurch Hospital were included. All procedures wereperformed with local anaesthetic under fluoroscopic andintra-cardiac echo guidance. Trans-thoracic echo was per-formed pre-discharge and repeated at six months withbubble study. We report peri-procedural complicationsand recurrent stroke, TIA, peripheral embolism and death.

Results: See table below.

n

Patient characteristics

Total 54

Age – median [IQR] (years) 45 [37–49]

Men 33 (61%)

Indication for closure

Stroke 35 (65%)

TIA 16 (30%)

Peripheral embolism 1 (2%)

Stroke + pulmonary embolism 1 (2%)

Decompression Illness 1 (2%)

Procedural characteristics

Procedural success 54 (100%)

Amplatzer PFO occluder 54 (100%)

Mean procedure length ± SD (mins) 22.4 ± 7.3

Peri-procedural complications

Haematoma 1 (2%)

Follow up

Mean follow up ± SD (years) 3.0 ± 1.4

6 month ECHO with bubble 51 (94%)

Residual shunt 12 (22%)

Death 0

Stroke/TIA/embolic recurrence 0

Conclusion: PFO closure has been performed safely andeffectively with no serious peri-procedural complicationsand no adverse events in three year follow-up. PFO closure

may have a role in the management of carefully selectedpatients with presumed paradoxical embolism.

http://dx.doi.org/10.1016/j.hlc.2013.04.010

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Retrospective Review of Outcomes Following StressEchocardiography: A Single Centres Experience

P. Barr 1,∗, J. Pemberton 2

1 North Shore Hospital, Auckland, New Zealand2 Auckland Hospital, Auckland, New Zealand

Background: Stress echocardiography has been wellvalidated as a diagnostic and prognostic test. This retro-spective review was carried out to assess the outcomeswith respect to mortality and revascularisation followingstress echocardiography at Auckland City Hospital.

Methods: Data from all patients who underwent a stressechocardiogram between the 26th of April 2010 and 30thDecember 2011 were retrospectively collated. Inclusioncriteria included patients without known obstructive coro-nary disease referred to exclude inducible ischaemia. 476patients met these criteria. Data was collected on stresstesting parameters, subsequent anatomic testing, and out-comes including revascularisation, acute coronary diseaseand death from all cause.

Results: Regional wall motion abnormality (RWMA)was demonstrated in 54 patients (11%). Fifty-six percent(30) of these patients had an angiogram and 20% (6) ofthese received revascularisation. 419 (88%) had no RWMA.Eight percent (32) of these had an angiogram and 50%(25%) of these received revascularisation. Four (1%) ofpatients with no RWMA had acute coronary syndrome.Twenty-four patients died during the assessment period.The odds ratio for mortality were 2.15 if RWMA wasdetected, 2.6 if <85% maximum age predicted heart ratewas achieved, and 5.5 if a dobutamine stress echocardio-gram was required.

Conclusion: Stress echocardiography has prognosticimplications including but not limited to assessment ofRWMA. Chronotropic response to stress and ability to per-form exercise stress may be more important prognosticindicators than RWMA.

http://dx.doi.org/10.1016/j.hlc.2013.04.011

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A Booklet on Participants’ Rights to Improve Consent forClinical Research: A Randomised Trial

J.R. Benatar ∗, J. Mortimer, M. Stretton, R.A.H. Stewart

Green Lane Cardiovascular Service, Auckland City Hospital,Auckland, New Zealand

Background: Information on the rights of subjects inclinical trials has become increasingly complex and diffi-cult to understand. This study evaluates whether a simplebooklet which is relevant to all research studies improves

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552 Abstracts Heart, Lung and CirculationCSANZ 2013 NZ Abstracts 2013;22:548–593

the understanding of rights needed for subjects to provideinformed consent.

Methods: A booklet designed to provide informationon participants’ rights which used simple language wasdeveloped to replace this information in current ICF’s. 282hospital inpatients were randomised to one of three waysto present research information; a standard ICF, the book-let combined with a short ICF, or the booklet combinedwith a simplified ICF. Comprehension of informationrelated to the research proposal and to participant’s rightswas assessed by questionnaire.

Results: Information related to participants’ rights con-tributed an average of 44% of the words in standard ICFs,and was harder to read than information describing theclinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003).Comprehension assessed in inpatients was better for thebooklet and short ICF 62%, (95% CI 56 to 67) correct, orsimplified ICF 62% (CI 58 to 68) correct compared to 52%,(CI 47 to 57) correct for the standard ICF, p = 0.009. This wasdue to better understanding of questions on rights (62% vs.49% correct, p = 0.0008). Comprehension of study relatedinformation was similar for the simplified and standardICF (60% vs. 64% correct, p = 0.68).

Conclusions: A booklet provides a simple, consistentapproach to providing information on participant rightswhich is relevant to all research studies, and improvescomprehension of patients who typically participate inclinical trials.

http://dx.doi.org/10.1016/j.hlc.2013.04.012

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A Randomised Trial Evaluating the Effects of Change inDairy Food Consumption on Cardio-Metabolic Risk Fac-tors

J.R. Benatar ∗, E. Jones, H. White, R.A.H. Stewart

Green Lane Cardiovascular Service, Auckland City Hospital,Auckland, New Zealand

Background: It is currently not known whether dairyfood influences the risk of cardiovascular disease or dia-betes. This study evaluates effects of changing dairy intakeon cardio metabolic risk factors.

Methods: 180 healthy volunteers were randomised toincrease, reduce or not change their dairy intake for onemonth in response to dietary advice. Body weight, waistcircumference, blood pressure, fasting plasma lipids,insulin resistance, and C-reactive protein (CRP) were mea-sured at baseline and after one month and compared bydietary group.

Results: Ninety-eight percent completed the study.Change in self-reported dairy intake for increaseddairy food was +09 ± 1.1 g/day (71%), no change was−2.1 ± 0.4 g/day (15%) and decreased dairy food was−10.8 ± 1.2 g/day (77%) respectively. There was no sta-tistically significant change in LDL or HDL cholesterol,triglycerides, systolic or diastolic blood pressure, C-reactive protein, glucose or insulin with 95% confidenceinterval standard mean differences <0.2 for all and

CRP < 0.3. There was a small increase in weight (0.4 kg (SD3.1)) in those asked to increase dairy food.

Conclusions: In healthy volunteers dietary advice tochange dairy intake for one month did not have a clinicallysignificant effect on cardio-metabolic risk factors. Theseobservations suggest that dairy food can be included aspart of a normal healthy diet without increasing cardio-metabolic risk.

http://dx.doi.org/10.1016/j.hlc.2013.04.013

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Effects of Increasing Dairy Food on Cardio-MetabolicRisk Factors: A Meta-Analysis of Randomised Studies

J.R. Benatar ∗, K. Sidhu, R.A.H. Stewart

Green Lane Cardiovascular Service, Auckland City Hospital,Auckland, New Zealand

Background: The effects of dairy food on cardiovascularand metabolic risk factors are uncertain, with conflictingassociations reported from large observational studies. Tobetter inform dietary guidelines we undertook a meta-analysis of randomised studies that evaluated effects ofchanging dairy intake on cardio-metabolic risk factors.

Methods: A systematic literature review identified allrandomised studies which compared at least one of thefollowing cardio-metabolic risk factors on a higher andlower dairy diet taken for at least one month; body weight,waist circumference, blood pressure, LDL cholesterol,insulin, glucose, insulin resistance (HOMA-IR) and C-reactive protein. Differences by dietary intervention wereexpressed as the effect size and 95% confidence interval(CI).

Results: Thirteen studies with 1131 participants wereincluded, 11 with a parallel group and two a cross-overdesign. The median duration of dietary change was 26 (IQR10–39) weeks and the mean change in dairy intake 3.6 (SD0.92) serves/day. On the higher compared to lower dairydiet there was no significant difference in weight, −0.06(95% CI, −0.026 to 0.086); systolic blood pressure 0.15 (95%CI −2.07 to 2.37; LDL cholesterol 0.16 (CI −0.04 to 2.14),HOMA-IR −0.65 (CI −2.61 to 1.31) or C-reactive protein−0.35 (CI −1.33 to 0.63).

Conclusion: Current evidence from randomised stud-ies suggests that changing dairy food intake has neitheradvantageous nor harmful effects on cardio-metabolic riskfactors.

http://dx.doi.org/10.1016/j.hlc.2013.04.014