Signe Stelling Risom

ICU-recovery in Scandinavia: a comparative study of intensive care follow-up in Denmark, Norway and Sweden.

OBJECTIVES The aim of our study was to describe and compare models of intensive care follow-up in Denmark, Norway and Sweden to help inform clinicians regarding the establishment and continuation of ICU aftercare programmes. METHODS Our study had a multi-centre comparative qualitative design with triangulation of sources, methods and investigators. We combined prospective data from semi-structured key-informant telephone interviews and unreported data from a precursory investigation. RESULTS Four basic models of follow-up were identified representing nurse-led or multidisciplinary programmes with or without the provision of patient diaries. A conceptual model was constructed including a catalogue of interventions related to the illness trajectory. We identified three temporal areas for follow-up directed towards the past, present or future. CONCLUSIONS ICU follow-up programmes in the Scandinavian countries have evolved as bottom-up initiatives conducted on a semi-voluntary basis. We suggest reframing follow-up as an integral part of patient therapy. The Scandinavian programmes focus on the human experience of critical illness, with more attention to understanding the past than looking towards the future. We recommend harmonization of programmes with clear goals enabling programme assessment, while moving towards a paradigm of empowerment, enabling patient and family to take an active role in their recovery and wellbeing.

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

BackgroundHeart 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.MethodsA 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.DiscussionThe 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).Trial registrationClinicalTrials.gov (http://NCT01558765).

The effect of integrated cardiac rehabilitation versus treatment as usual for atrial fibrillation patients treated with ablation: the randomised CopenHeartRFA trial protocol

Introduction Atrial fibrillation affects almost 2% of the population in the Western world. To preserve sinus rhythm, ablation is undertaken in symptomatic patients. Observational studies show that patients with atrial fibrillation often report a low quality of life and are less prone to be physically active due to fear of triggering fibrillation. Small trials indicate that exercise training has a positive effect on exercise capacity and mental health, and both patients with recurrent atrial fibrillation and in sinus rhythm may benefit from rehabilitation in managing life after ablation. No randomised trials have been published on cardiac rehabilitation for atrial fibrillation patients treated with ablation that includes exercise and psychoeducational components. Aim To test the effects of an integrated cardiac rehabilitation programme versus treatment as usual for patients with atrial fibrillation treated with ablation. Methods and analysis design The trial is a multicentre parallel arm design with 1:1 randomisation to the intervention and control group with blinded outcome assessment. 210 patients treated for atrial fibrillation with radiofrequency ablation will be included. The intervention consists of a rehabilitation programme including four psychoeducative consultations with a specially trained nurse and 12 weeks of individualised exercise training, plus the standard medical follow-up. Patients in the control group will receive the standard medical follow-up. The primary outcome measure is exercise capacity measured by the VO2 peak. The secondary outcome measure is self-rated mental health measured by the Short Form 36 questionnaire. Postintervention, qualitative interviews will be conducted in 10% of the intervention group. Ethics and dissemination The protocol is approved by the regional research ethics committee (number H-1-2011-135), the Danish Data Protection Agency (reg. nr. 2007-58-0015) and follows the latest version of the Declaration of Helsinki. The results will be published in peer-reviewed journals and may possibly impact on rehabilitation guidelines. Trial registration Clinicaltrials.gov identifier: NCT01523145.

Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial

Objective The evidence for cardiac rehabilitation after valve surgery remains sparse. Current recommendations are therefore based on patients with ischaemic heart disease. The aim of this randomised clinical trial was to assess the effects of cardiac rehabilitation versus usual care after heart valve surgery. Methods The trial was an investigator-initiated, randomised superiority trial (The CopenHeartVR trial, VR; valve replacement or repair). We randomised 147 patients after heart valve surgery 1:1 to 12 weeks of cardiac rehabilitation consisting of physical exercise and monthly psycho-educational consultations (intervention) versus usual care without structured physical exercise or psycho-educational consultations (control). Primary outcome was physical capacity measured by VO2 peak and secondary outcome was self-reported mental health measured by Short Form-36. Results 76% were men, mean age 62 years, with aortic (62%), mitral (36%) or tricuspid/pulmonary valve surgery (2%). Cardiac rehabilitation compared with control had a beneficial effect on VO2 peak at 4 months (24.8 mL/kg/min vs 22.5 mL/kg/min, p=0.045) but did not affect Short Form-36 Mental Component Scale at 6 months (53.7 vs 55.2 points, p=0.40) or the exploratory physical and mental outcomes. Cardiac rehabilitation increased the occurrence of self-reported non-serious adverse events (11/72 vs 3/75, p=0.02). Conclusions Cardiac rehabilitation after heart valve surgery significantly improves VO2 peak at 4 months but has no effect on mental health and other measures of exercise capacity and self-reported outcomes. Further research is needed to justify cardiac rehabilitation in this patient group. Trial registration number NCT01558765, Results.

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

BACKGROUND 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. METHODS 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. RESULTS 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). CONCLUSION 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.

A randomised clinical trial of comprehensive cardiac rehabilitation versus usual care for patients treated for infective endocarditis--the CopenHeartIE trial protocol.

Introduction Infective endocarditis (IE) is among the most serious infectious diseases in the western world. Treatment requires lengthy hospitalisation, high-dosage antibiotic therapy and possible valve replacement surgery. Despite advances in treatment, the 1-year mortality remains at 20–40%. Studies indicate that patients experience persisting physical symptoms, diminished quality of life and difficulties returning to work up to a year postdischarge. No studies investigating the effects of rehabilitation have been published. We present the rationale and design of the CopenHeartIE trial, which investigates the effect of comprehensive cardiac rehabilitation versus usual care for patients treated for IE. Methods and analysis We will conduct a randomised clinical trial to investigate the effects of comprehensive cardiac rehabilitation versus usual care on the physical and psychosocial functioning of patients treated for IE. The trial is a multicentre, parallel design trial with 1 : 1 individual randomisation to either the intervention or control group. The intervention consists of five psychoeducational consultations provided by specialised nurses and a 12-week exercise training programme. The primary outcome is mental health (MH) measured by the standardised Short Form 36 (SF-36). The secondary outcome is peak oxygen uptake measured by the bicycle ergospirometry test. Furthermore, a number of exploratory analyses will be performed. Based on sample size calculation, 150 patients treated for left-sided (native or prosthetic valve) or cardiac device endocarditis will be included in the trial. A qualitative and a survey-based complementary study will be undertaken, to investigate postdischarge experiences of the patients. A qualitative postintervention study will explore rehabilitation participation experiences. Ethics and dissemination The study complies with the Declaration of Helsinki and was approved by the regional research ethics committee (no H-1-2011-129) and the Danish Data Protection Agency (no 2007-58-0015). Study findings will be disseminated widely through peer-reviewed publications and conference presentations. Registration Clinicaltrials.gov identifier: NCT01512615.

Validating the HeartQoL questionnaire in patients with atrial fibrillation

Background Atrial fibrillation (AF) is associated with impaired health-related quality-of-life (HRQL). When assessing HRQL, disease-specific and generic instruments are used, which may hinder outcome comparisons across studies. A newly developed core ischaemic heart disease-specific HRQL questionnaire, the HeartQoL, offers a single measurement instrument which may allow outcome comparisons across cardiac diseases. The aim of the study was to evaluate the psychometric properties of HeartQoL in an AF population treated with ablation by assessing its factor structure, construct validity, internal consistency, and test–retest reliability. Design and methods Data were collected in two phases: (a) a cross-sectional study including 462 patients with AF/atrial flutter who completed the HeartQoL and the Short-Form 36 (SF-36), allowing for the evaluation of internal consistency, factor structure and construct validity; and (b) a longitudinal study including 55 patients completing HeartQoL twice to evaluate test–retest reliability. Results The two-factor structure of HeartQoL was largely confirmed in patients with AF. Internal consistency was high (Cronbach’s alpha (α) ≥ 0.90) and test–retest reliability good (intra-class correlation ≥ 0.90). The construct validity was supported, as subscales of HeartQoL correlated strongly with similar (r ≥ 0.78) and weakly (r ≤ 0.47) with dissimilar subscales of SF-36. The HeartQoL demonstrated ability to distinguish between different clinical subgroups of patients, indicating sensitivity. Conclusion The HeartQoL showed overall satisfactory psychometric properties, demonstrating it to be a valid instrument in the evaluation of HRQL in patients with AF treated with ablation. This suggests that HeartQoL may be a valuable instrument for making HRQL comparisons across the spectrum of cardiac diseases.

Sex differences in health status and rehabilitation outcomes in patients with atrial fibrillation treated with ablation: Results from the CopenHeartRFA trial.

Background: Increased physical capacity after comprehensive rehabilitation in patients with atrial fibrillation (AF) undergoing ablation has been found in the CopenHeartRFA trial. The purpose of this study was to investigate: (a) sex differences in health status, psychological distress and quality of life, (b) sex differences in rehabilitation outcomes and (c) predictors of effect of rehabilitation. Methods: We conducted an exploratory analysis of data from the randomized CopenHeartRFA trial, where patients treated with ablation were randomized with 1:1 to comprehensive rehabilitation consisting of a physical exercise program and psycho-educational consultations versus usual care. Sex disparities in health status were tested using Chi-square and t-tests. Results: Included were: 151 men (median age 59.25 years) and 59 women (median age 62.5 years). At hospital discharge, women reported lower physical health status compared with men. Among women, significant differences were found in the 6-min walk test [rehabilitation: 496.8 meters (SD 98.5) versus 559.3meters (SD 55.5) and usual care: 521.9 meters (SD 97.8) versus 530.9 meters (SD 102.2), p = 0.01] and exercise time [rehabilitation: 387.6 s (SD 126.0) versus 463.2 s (SD 121.8) and usual care: 353.4 s (SD 145.2) versus 355.8 s (SD 154.8), p < 0.004] and among men in the sit-to-stand test. Significant differences were found in mental health outcomes among men and in quality of life scores among women. Patients with a European Heart Rhythm Association (EHRA) score I-II had a positive effect of rehabilitation. Conclusion: The results suggest that sex differences exist in self-reported health after rehabilitation in patients ablated for AF. Patients with an I–II EHRA score seem more likely to gain from the rehabilitation programme compared with those with a III–IV score.

Effect of Rehabilitation on Sleep Quality After Ablation for Atrial Fibrillation: Data From a Randomized Trial

Background: Low sleep quality is common in patients with atrial fibrillation (AF). Positive effects of cardiac rehabilitation on patients treated for AF with ablation have been found, but whether cardiac rehabilitation affects sleep quality is unknown. The objectives of this study were to investigate (1) differences in sleep quality between cardiac rehabilitation and usual care groups and (2) whether other factors could affect sleep quality. Methods: From the randomized CopenHeartRFA trial, 210 patients treated for AF with ablation were included. A rehabilitation program consisting of physical exercise and psychoeducational consultations was tested. Sleep quality was measured with the Pittsburg Sleep Quality Index (PSQI) questionnaire before intervention and at the end of intervention. Anxiety, depression, and European Heart Rhythm Association scores were assessed. Results: No difference between groups in sleep quality was found (PSQI global mean [SD] score, 6.60 [3.61] points for the cardiac rehabilitation group [n = 83] and 6.08 [3.60] points for the usual care group [n = 90]; P = .34), although improvements in sleep quality were noted in both groups. Sleep latency, duration, and efficiency were significant by type of AF at 1 month. Anxiety, depression, and higher European Heart Rhythm Association scores at 4 months were associated with a higher PSQI global mean score at the end of intervention. Conclusion: The rehabilitation program showed no effect on sleep quality. A large proportion of patients reported poor sleep quality, and patients reporting anxiety, depression, or AF symptoms described worse sleep quality compared with patients who did not experience anxiety, depression, or AF symptoms. More research in the field is warranted.

Patient perspectives of participating in the cardiac CopenHeartRFA rehabilitation program for patients treated with ablation for atrial fibrillation

Purpose The CopenHeartRFA trial was designed and conducted to explore the effects of rehabilitation on patients treated with ablation for atrial fibrillation (AF). It included a cardiac rehabilitation program consisting of physical exercise and psychoeducational consultations over 6 months. As part of the evaluation of the CopenHeartRFA trial, both quantitative and qualitative data were collected. The intervention was delivered by a multidisciplinary team. Aim This study aimed to understand the experience of patients treated for AF with ablation who participated in the CopenHeartRFA cardiac rehabilitation program. Methods A qualitative descriptive design was used. A purposive sample of 10 patients who had completed the intervention consented to participate. The interviews were conducted face-to-face and were audio-recorded and transcribed. Qualitative content analyses were used to analyze the data. The interviews were analyzed individually by two researchers and themes were constructed and discussed. Results The sample included 10 participants, mean age 54.6 years. Four categories were identified and labeled: 1) strengthening belief in one’s own physical capacity and survival; 2) still struggling with fear of AF symptoms; 3) a need for support to move on; and 4) regaining confidence in one’s own mental strength with support from professionals. Conclusion The four themes describe a positive experience from participating in the rehabilitation program. The rehabilitation program promoted self-efficacy for engaging in physical activity and the benefit of a safe environment for processing the emotional responses and the value of the therapeutic relationship between the patient and the rehabilitation provider.