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Cardiac rehabilitation versus usual care for patients treated with catheter ablation for atrial fibrillation: Results of the randomized CopenHeartRFA trial.

https://arctichealth.org/en/permalink/ahliterature282780
Source
Am Heart J. 2016 Nov;181:120-129
Publication Type
Article
Date
Nov-2016
Author
Signe S Risom
Ann-Dorthe Zwisler
Trine B Rasmussen
Kirstine Lærum Sibilitz
Trine L S Madsen
Jesper Hastrup Svendsen
Christian Gluud
Jane Lindschou
Per Winkel
Selina Kikkenborg Berg
Source
Am Heart J. 2016 Nov;181:120-129
Date
Nov-2016
Language
English
Publication Type
Article
Keywords
Aftercare
Aged
Atrial Fibrillation - psychology - rehabilitation - surgery
Cardiac Rehabilitation - methods
Catheter Ablation - methods
Denmark
Exercise Test
Exercise Therapy
Exercise Tolerance
Female
Humans
Male
Mental health
Middle Aged
Oxygen consumption
Patient Education as Topic
Quality of Life
Surveys and Questionnaires
Treatment Outcome
Abstract
To assess the effects of comprehensive cardiac rehabilitation compared with usual care on physical activity and mental health for patients treated with catheter ablation for atrial fibrillation.
The patients were randomized 1:1 stratified by paroxysmal or persistent atrial fibrillation and sex to cardiac rehabilitation consisting of 12 weeks physical exercise and four psycho-educational consultations plus usual care (cardiac rehabilitation group) versus usual care. The primary outcome was Vo2 peak. The secondary outcome was self-rated mental health measured by the Short Form-36 questionnaire. Exploratory outcomes were collected.
210 patients were included (mean age: 59 years, 74% men), 72% had paroxysmal atrial fibrillation prior to ablation. Compared with usual care, the cardiac rehabilitation group had a beneficial effect on Vo2 peak at four months (24.3mL kg(-1) min(-1) versus 20.7mL kg(-1) min(-1), p of main effect=0.003, p of interaction between time and intervention=0.020). No significant difference between groups on Short Form-36 was found (53.8 versus 51.9 points, P=.20). Two serious adverse events (atrial fibrillation in relation to physical exercise and death unrelated to rehabilitation) occurred in the cardiac rehabilitation group versus one in the usual care group (death unrelated to intervention) (P=.56). In the cardiac rehabilitation group 16 patients versus 7 in the usual care group reported non-serious adverse events (P=.047).
Comprehensive cardiac rehabilitation had a positive effect on physical capacity compared with usual care, but not on mental health. Cardiac rehabilitation caused more non-serious adverse events.
PubMed ID
27823683 View in PubMed
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Clarithromycin for stable coronary heart disease increases all-cause and cardiovascular mortality and cerebrovascular morbidity over 10years in the CLARICOR randomised, blinded clinical trial.

https://arctichealth.org/en/permalink/ahliterature268775
Source
Int J Cardiol. 2015 Mar 1;182:459-65
Publication Type
Article
Date
Mar-1-2015
Author
Per Winkel
Jørgen Hilden
Jørgen Fischer Hansen
Jens Kastrup
Hans Jørn Kolmos
Erik Kjøller
Gorm Boje Jensen
Maria Skoog
Jane Lindschou
Christian Gluud
Source
Int J Cardiol. 2015 Mar 1;182:459-65
Date
Mar-1-2015
Language
English
Publication Type
Article
Keywords
Aged
Anti-Bacterial Agents - administration & dosage - adverse effects
Cause of Death - trends
Clarithromycin - administration & dosage - adverse effects
Coronary Artery Disease - drug therapy - mortality
Denmark - epidemiology
Female
Follow-Up Studies
Forecasting
Humans
Male
Morbidity - trends
Retrospective Studies
Single-Blind Method
Stroke - chemically induced - epidemiology
Abstract
The CLARICOR trial reported that clarithromycin compared with placebo increased all-cause mortality in patients with stable coronary heart disease. This study investigates the effects of clarithromycin versus placebo during 10years follow up.
The CLARICOR trial is a randomised, placebo-controlled trial including 4373 patients with stable coronary heart disease. The interventions were 2weeks of clarithromycin 500mg a day versus placebo. 10year follow up was performed through Danish public registers and analysed with Cox regression.
Clarithromycin increased all-cause mortality (hazard ratio (HR): 1.10, 95% confidence interval (CI): 1.00-1.21) and cerebrovascular disease during 10years (HR: 1.19, 95% CI: 1.02-1.38). The increased mortality and morbidity were restricted to patients not on statin at entry (HR: 1.16, 95% CI: 1.04-1.31, and HR: 1.25, 95% CI: 1.03-1.50). The assumption of constant HR during the 10years was violated for cardiovascular death (P=0.01) and cardiovascular death outside hospital (P
PubMed ID
25602299 View in PubMed
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Comprehensive cardiac rehabilitation improves outcome for patients with implantable cardioverter defibrillator. Findings from the COPE-ICD randomised clinical trial.

https://arctichealth.org/en/permalink/ahliterature266783
Source
Eur J Cardiovasc Nurs. 2015 Feb;14(1):34-44
Publication Type
Article
Date
Feb-2015
Author
Selina Kikkenborg Berg
Preben U Pedersen
Ann-Dorthe Zwisler
Per Winkel
Christian Gluud
Birthe D Pedersen
Jesper H Svendsen
Source
Eur J Cardiovasc Nurs. 2015 Feb;14(1):34-44
Date
Feb-2015
Language
English
Publication Type
Article
Keywords
Adult
Aged
Arrhythmias, Cardiac - psychology - rehabilitation - therapy
Behavior Therapy - methods
Defibrillators, Implantable
Denmark
Exercise Therapy - methods
Female
Humans
Male
Middle Aged
Patient Satisfaction - statistics & numerical data
Prospective Studies
Quality of Life
Rehabilitation - methods
Risk assessment
Treatment Outcome
Abstract
The aim of this randomised clinical trial was to assess a comprehensive cardiac rehabilitation intervention including exercise training and psycho-education vs 'treatment as usual' in patients treated with an implantable cardioverter defibrillator (ICD).
In this study 196 patients with first time ICD implantation (mean age 57.2 (standard deviation (SD)=13.2); 79% men) were randomised (1:1) to comprehensive cardiac rehabilitation vs 'treatment as usual'. Altogether 144 participants completed the 12 month follow-up. The intervention consisted of twelve weeks of exercise training and one year of psycho-educational follow-up focusing on modifiable factors associated with poor outcomes. Two primary outcomes, general health score (Short Form-36 (SF-36)) and peak oxygen uptake (VO2), were used. Post-hoc analyses included SF-36 and ICD therapy history.
Comprehensive cardiac rehabilitation significantly increased VO2 uptake after exercise training to 23.0 (95% confidence interval (CI) 20.9-22.7) vs 20.8 (95% CI 18.9-22.7) ml/min/kg in the control group (p=0.004 (multiplicity p=0.015)). Comprehensive cardiac rehabilitation significantly increased general health; at three months (mean 62.8 (95% CI 58.1-67.5) vs 64.4 (95% CI: 59.6-69.2)) points; at six months (mean 66.7 (95% CI 61.5-72.0) vs 61.9 (95% CI 56.1-67.7) points); and 12 months (mean 63.5 (95% CI 57.7-69.3) vs 62.1 (95% CI 56.2-68.0)) points (p
PubMed ID
24504872 View in PubMed
Less detail

Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial.

https://arctichealth.org/en/permalink/ahliterature112942
Source
Trials. 2013;14:104
Publication Type
Article
Date
2013
Author
Kirstine Laerum Sibilitz
Selina Kikkenborg Berg
Tina Birgitte Hansen
Signe Stelling Risom
Trine Bernholdt Rasmussen
Christian Hassager
Lars Køber
Daniel Steinbrüchel
Christian Gluud
Per Winkel
Lau Caspar Thygesen
Jane Lindschou Hansen
Jean Paul Schmid
Viviane Conraads
Barbara Christina Brocki
Ann-Dorthe Zwisler
Author Affiliation
The Heart Centre, Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. kirstine.laerum.sibilitz@rh.regionh.dk
Source
Trials. 2013;14:104
Date
2013
Language
English
Publication Type
Article
Keywords
Cardiac Surgical Procedures - adverse effects - economics - mortality - psychology - rehabilitation
Clinical Protocols
Combined Modality Therapy
Cost-Benefit Analysis
Denmark
Exercise Test
Exercise Therapy - economics
Health Care Costs
Health Knowledge, Attitudes, Practice
Heart Valve Diseases - economics - mortality - physiopathology - psychology - rehabilitation - surgery
Humans
Mental health
Oxygen consumption
Patient Education as Topic - economics
Postoperative Care
Questionnaires
Recovery of Function
Referral and Consultation - economics
Research Design
Time Factors
Treatment Outcome
Abstract
Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery.
A randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study.
The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015).
ClinicalTrials.gov (http://NCT01558765).
Notes
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PubMed ID
23782510 View in PubMed
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Effect of guided self-determination youth intervention integrated into outpatient visits versus treatment as usual on glycemic control and life skills: a randomized clinical trial in adolescents with type 1 diabetes.

https://arctichealth.org/en/permalink/ahliterature263209
Source
Trials. 2014;15:321
Publication Type
Article
Date
2014
Author
Gitte R Husted
Birger Thorsteinsson
Bente Appel Esbensen
Christian Gluud
Per Winkel
Eva Hommel
Vibeke Zoffmann
Source
Trials. 2014;15:321
Date
2014
Language
English
Publication Type
Article
Keywords
Adolescent
Adolescent Behavior
Ambulatory Care - methods
Biological Markers - blood
Blood Glucose - drug effects - metabolism
Delivery of Health Care, Integrated
Denmark
Diabetes Mellitus, Type 1 - blood - diagnosis - psychology - therapy
Female
Health Behavior
Health Knowledge, Attitudes, Practice
Hemoglobin A, Glycosylated - metabolism
Humans
Hypoglycemia - blood - chemically induced - prevention & control
Hypoglycemic Agents - adverse effects - therapeutic use
Insulin - adverse effects - therapeutic use
Intention to Treat Analysis
Male
Motivation
Personal Autonomy
Self Care
Time Factors
Treatment Outcome
Abstract
Providing care for adolescents with type 1 diabetes is complex, demanding, and often unsuccessful. Guided self-determination (GSD) is a life skills approach that has been proven effective in caring for adults with type 1 diabetes. To improve care, GSD was revised for adolescents, their parents, and interdisciplinary healthcare providers (HCP) to create GSD-Youth (GSD-Y). We evaluated the impact of GSD-Y after it was integrated into pediatric outpatient visits versus treatment-as-usual, focusing on glycemic control and the development of life skills in adolescents with type 1 diabetes.
Seventy-one adolescents (mean age: 15 years, mean duration of diabetes: 5.7 years, mean HbA1c: 77 mmol/mol (9.1%), upon entering the study) from two pediatric departments were randomized into a GSD-Y group (n = 37, GSD-Y was provided during individual outpatient sessions) versus a treatment-as-usual group (n = 34). The primary outcome was the HbA1c measurement. The secondary outcomes were life skills development (assessed by self-reported psychometric scales), self-monitored blood glucose levels, and hypo- and hyperglycemic episodes. The analysis followed an intention-to-treat basis.
Fifty-seven adolescents (80%) completed the trial, and 53 (75%) completed a six-month post-treatment follow-up. No significant effect of GSD-Y on the HbA1c could be detected in a mixed-model analysis after adjusting for the baseline HbA1c levels and the identity of the HCP (P = 0.85). GSD-Y significantly reduced the amotivation for diabetes self-management after adjusting for the baseline value (P = 0.001). Compared with the control group, the trial completion was prolonged in the GSD-Y group (P
Notes
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PubMed ID
25118146 View in PubMed
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Excess sudden cardiac deaths after short-term clarithromycin administration in the CLARICOR trial: why is this so, and why are statins protective?

https://arctichealth.org/en/permalink/ahliterature135789
Source
Cardiology. 2011;118(1):63-7
Publication Type
Article
Date
2011
Author
Per Winkel
Jørgen Hilden
Jørgen Fischer Hansen
Per Hildebrandt
Jens Kastrup
Hans Jørn Kolmos
Erik Kjøller
Christian M Jespersen
Christian Gluud
Gorm Boje Jensen
Author Affiliation
Rigshospitalet, Copenhagen University Hospital and Institute of Preventive Medicine, The Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen, Denmark.
Source
Cardiology. 2011;118(1):63-7
Date
2011
Language
English
Publication Type
Article
Keywords
Anti-Bacterial Agents - adverse effects
Clarithromycin - adverse effects
Coronary Artery Disease - drug therapy - mortality
Death, Sudden, Cardiac - etiology - prevention & control
Denmark - epidemiology
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
Randomized Controlled Trials as Topic
Abstract
To elucidate potential mechanisms for the clarithromycin-induced excess mortality observed in the CLARICOR trial during 2.6 year follow-up of patients with stable coronary artery disease.
Cox analyses using out-of-hospital death as a proxy for sudden death compared to in-hospital (nonsudden) death.
In 100 of 189 (53%) cardiovascular (CV) deaths in which it was possible to examine the question, there was a strong association between place of death and the classification of CV death as sudden or not-sudden. The excess mortality in the clarithromycin group was confined to sudden CV death in patients not on statins at trial entry (HR: 2.61, 95% CI: 1.69-4.05, p
PubMed ID
21447948 View in PubMed
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Good interobserver agreement was attainable on outcome adjudication in patients with stable coronary heart disease.

https://arctichealth.org/en/permalink/ahliterature127854
Source
J Clin Epidemiol. 2012 Apr;65(4):444-53
Publication Type
Article
Date
Apr-2012
Author
Erik Kjoller
Jorgen Hilden
Per Winkel
Niels J Frandsen
Soren Galatius
Gorm Jensen
Jens Kastrup
Jorgen Fischer Hansen
Hans J Kolmos
Christian M Jespersen
Per Hildebrandt
Christian Gluud
Author Affiliation
Department of Cardiology, Copenhagen University Hospital, Herlev Hospital, Herlev Ringvej 75, Herlev, Denmark. kjoller@dadlnet.dk
Source
J Clin Epidemiol. 2012 Apr;65(4):444-53
Date
Apr-2012
Language
English
Publication Type
Article
Keywords
Algorithms
Anti-Bacterial Agents - therapeutic use
Chlamydia Infections - complications
Chlamydophila pneumoniae - isolation & purification
Clarithromycin - therapeutic use
Confidence Intervals
Coronary Disease - drug therapy - microbiology - mortality - therapy
Denmark
Follow-Up Studies
Humans
Inpatients
Myocardial Infarction - drug therapy - microbiology - therapy
Observer Variation
Prognosis
Risk assessment
Survival Analysis
Treatment Outcome
Abstract
In clinical trials, agreement on outcomes is of utmost importance for valid estimation of intervention effects. As there is limited knowledge about adjudicator agreement in cardiology, we examined the level of agreement among three cardiology specialists adjudicating all possible events in a randomized controlled clinical trial of patients with stable coronary heart disease.
All information (hospital records, death certificates, etc.) was forwarded to two randomly selected blinded adjudicators. If they disagreed, the third arbiter had to choose the more likely of the two alternatives. Files of 5,475 nonfatal and 362 fatal events were evaluated.
For nonfatal outcomes, pairwise kappa values ranged from 0.75 to 0.80. The three adjudicators had 4.3%, 9.5%, and 6.1% of their nonfatal outcome classifications overruled by their arbiter. If stable angina pectoris, unstable angina pectoris, and acute myocardial infarction were treated as one, agreement increased minimally. For fatal outcomes, the pairwise kappa values ranged from 0.65 to 0.90. The three adjudicators had 12%, 9%, and 10% of their death classifications overruled.
Specialists in cardiology can attain a reasonably high agreement on outcomes in patients with stable coronary heart disease.
PubMed ID
22257841 View in PubMed
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Group-based antenatal birth and parent preparation for improving birth outcomes and parenting resources: study protocol for a randomised trial.

https://arctichealth.org/en/permalink/ahliterature107206
Source
Sex Reprod Healthc. 2013 Oct;4(3):121-6
Publication Type
Article
Date
Oct-2013
Author
Vibeke Koushede
Carina Sjöberg Brixval
Solveig Forberg Axelsen
Jane Lindschou
Per Winkel
Rikke Damkjær Maimburg
Pernille Due
Author Affiliation
National Institute of Public Health, University of Southern Denmark, Denmark. Electronic address: vibe@niph.dk.
Source
Sex Reprod Healthc. 2013 Oct;4(3):121-6
Date
Oct-2013
Language
English
Publication Type
Article
Keywords
Adult
Analgesia, Epidural - utilization
Cost-Benefit Analysis
Denmark
Female
Health Resources
Humans
Parents
Patient Education as Topic - methods
Pregnancy
Prenatal Care - methods
Questionnaires
Research Design
Treatment Outcome
Abstract
To examine the efficacy and cost-effectiveness of group based antenatal education for improving childbirth and parenting resources compared to auditorium based education.
2350 Danish pregnant women and their partners =18 years old, recruited before 20+0 gestational weeks. Population-based individually randomised superiority trial with two parallel arms: Four sessions of birth and parent preparation in small groups (experimental group); two lectures in an auditorium (control group). Data is collected by (1) questionnaires at baseline (˜18 weeks of gestation), 37 weeks of gestation, 9 weeks-, 6 months-, and 1 year post-partum, (2) the hospital obstetric database, (3) national registers.
use of epidural analgesia.
stress, parenting alliance; explorative outcomes: depressive symptoms, use of health care services, self-efficacy, well-being, family break-ups. Analyses will be intention-to-treat as well as per protocol. Process evaluation will be conducted using questionnaires and qualitative interviews. The incremental societal cost of the intervention will be computed and compared to the measured outcomes in a cost-effectiveness analysis.
To the best of our knowledge this is the largest well-designed randomised trial of its kind to date. The trial will bring much-needed evidence for decision makers of the content and form of antenatal education.
PubMed ID
24041733 View in PubMed
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High-sensitivity C-reactive protein and N-terminal pro-B-type natriuretic peptide in patients with stable coronary artery disease: a prognostic study within the CLARICOR trial.

https://arctichealth.org/en/permalink/ahliterature139052
Source
Scand J Clin Lab Invest. 2011 Feb;71(1):52-62
Publication Type
Article
Date
Feb-2011
Author
Marina J Harutyunyan
Anders B Mathiasen
Per Winkel
Jens P Gøtze
Jørgen Fischer Hansen
Per Hildebrandt
Gorm Boje Jensen
Jørgen Hilden
Christian M Jespersen
Erik Kjøller
Hans J Kolmos
Christian Gluud
Jens Kastrup
Author Affiliation
Department of Medicine B, The Heart Centre, Rigshospitalet, Copenhagen University Hospital and Faculty of Health Sciences, Denmark.
Source
Scand J Clin Lab Invest. 2011 Feb;71(1):52-62
Date
Feb-2011
Language
English
Publication Type
Article
Keywords
Aged
Angina, Unstable - blood - complications
C-Reactive Protein - metabolism
Confidence Intervals
Coronary Artery Disease - blood - mortality
Denmark - epidemiology
Female
Humans
Male
Myocardial Infarction - blood
Natriuretic Peptide, Brain - blood
Peptide Fragments - blood
Prognosis
Proportional Hazards Models
Abstract
Patients with stable coronary artery disease (CAD) have a poor prognosis. The aim of the study was to evaluate the extent to which serum high-sensitivity C-reactive protein (hs-CRP) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) measurement alone or together could be prognostic biomarkers in patients with stable CAD.
During the 2.6-year follow-up period 270 patients among the 4264 patients with stable CAD in the CLARICOR trial suffered myocardial infarction (MI) and 377 died (187 cardiovascular deaths (CVD)).
Serum NT-proBNP was significantly associated with MI (hazard ratio (HR), 1. 65 (refers to a 2.72 fold increase in serum level, p = 0.0005), CVD (HR, 2.42, p
PubMed ID
21108561 View in PubMed
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Instructor feedback versus no instructor feedback on performance in a laparoscopic virtual reality simulator: a randomized educational trial.

https://arctichealth.org/en/permalink/ahliterature126613
Source
BMC Med Educ. 2012;12:7
Publication Type
Article
Date
2012
Author
Jeanett Oestergaard
Flemming Bjerrum
Mathilde Maagaard
Per Winkel
Christian Rifbjerg Larsen
Charlotte Ringsted
Christian Gluud
Teodor Grantcharov
Bent Ottesen
Jette Led Soerensen
Author Affiliation
Department of Obstetrics and Gynecology, Juliane Marie Centre, Centre for Women, Children and Reproduction, Rigshospitalet, University Hospital of Copenhagen, Blegdamsvej 9, Copenhagen 2100, Denmark. jeanett78@gmail.com
Source
BMC Med Educ. 2012;12:7
Date
2012
Language
English
Publication Type
Article
Keywords
Adult
Analysis of Variance
Clinical Competence
Computer simulation
Denmark
Education, Medical, Undergraduate - methods
Educational Measurement
Faculty, Medical
Feedback
Female
Humans
Laparoscopy - education
Linear Models
Male
Reference Values
Salpingectomy - education - methods
Students, Medical - statistics & numerical data
Task Performance and Analysis
User-Computer Interface
Young Adult
Abstract
Several studies have found a positive effect on the learning curve as well as the improvement of basic psychomotor skills in the operating room after virtual reality training. Despite this, the majority of surgical and gynecological departments encounter hurdles when implementing this form of training. This is mainly due to lack of knowledge concerning the time and human resources needed to train novice surgeons to an adequate level. The purpose of this trial is to investigate the impact of instructor feedback regarding time, repetitions and self-perception when training complex operational tasks on a virtual reality simulator.
The study population consists of medical students on their 4th to 6th year without prior laparoscopic experience. The study is conducted in a skills laboratory at a centralized university hospital. Based on a sample size estimation 98 participants will be randomized to an intervention group or a control group. Both groups have to achieve a predefined proficiency level when conducting a laparoscopic salpingectomy using a surgical virtual reality simulator. The intervention group receives standardized instructor feedback of 10 to 12 min a maximum of three times. The control group receives no instructor feedback. Both groups receive the automated feedback generated by the virtual reality simulator. The study follows the CONSORT Statement for randomized trials. Main outcome measures are time and repetitions to reach the predefined proficiency level on the simulator. We include focus on potential sex differences, computer gaming experience and self-perception.
The findings will contribute to a better understanding of optimal training methods in surgical education.
NCT01497782.
Notes
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PubMed ID
22373062 View in PubMed
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