The heart & mind trial: intervention with cognitive-behavioural therapy in patients with cardiac disease and anxiety: randomised controlled trial protocol.

INTRODUCTION: Patients with cardiac disease often experience anxiety (prevalence about 20%-25%) and have a doubled mortality risk when suffering from anxiety compared with patients without anxiety. This calls for interventions aiming to reduce anxiety. METHODS AND ANALYSIS: The Heart & Mind Trial consists of three parts: (1) screening of all hospitalised and outpatient cardiac patients with arrhythmia, heart failure or ischaemic heart disease at four university hospitals in Denmark using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A); Patients scoring ≥8 is invited to participate; (2) Assessment of the type of anxiety by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders and (3) Randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive-behavioural therapy (CBT) performed by a CBT-trained cardiac nurse plus usual care or, usual care alone. The primary outcome is anxiety measured with HADS-A at 5 months. Secondary outcomes include anxiety symptoms measured with Becks Anxiety Inventory and heart rate variability. Exploratory outcomes measured at 12 months include blood cortisol (stress response), blood C reactive protein (stress response), health-related quality of life, readmission, mortality and attributable direct costs. A total of 336 patients will be included. The primary analyses are based on the intention-to-treat principle. For the primary outcome, we will use a linear regression model. For the long-term outcomes, mixed regression models will be used including repeated measurements. ETHICS AND DISSEMINATION: The trial is performed in accordance with the Declaration of Helsinki. All patients must give informed consent prior to participation and the trial is initiated after approval by the Danish Data Protection Agency (P-2020-894) and the National Committee on Health Research Ethics (H-20066739). Positive, neutral and negative results of the trial will be published. TRIAL REGISTRATION NUMBER: NCT04582734.

Cognitive behavioural therapy significantly reduces anxiety in patients with implanted cardioverter defibrillator compared with usual care: Findings from the Screen-ICD randomised controlled trial.

AIM: The aim of this study was to investigate the effect of a cognitive behavioural therapy intervention provided by trained cardiac nurses plus usual care compared with usual care alone in patients with an implanted cardioverter defibrillator who, prior to randomization, had presented with symptoms of anxiety measured by the Hospital Anxiety and Depression Scale. BACKGROUND: Around 20-25% of all patients with an implanted cardioverter defibrillator experience anxiety. Among these patients anxiety is associated with mortality, presumably explained by risk behaviour and activation of the autonomic nervous system. We hypothesised that cognitive behavioural therapy provided by cardiac nurses in an out-patient setting would be an effective treatment of anxiety. METHODS: This was an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive behavioural therapy plus usual care or to usual care. The primary outcome was Hospital Anxiety and Depression Scale-Anxiety mean score at 16 weeks. Secondary outcomes included Hospital Anxiety and Depression Scale-Depression, Becks Anxiety Inventory, HeartQoL and Hamilton Anxiety Scale. Primary outcome analysis was based on the intention-to-treat principle. RESULTS: A total of 88 participants were included, 66% men, mean age 64.3 years and 61% had primary indication implantable cardioverter defibrillator. A significant difference after 16 weeks was found between groups: intervention group (Hospital Anxiety and Depression Scale-A mean (standard deviation) 4.95 points (3.30) versus usual care group 8.98 points (4.03) (p < 0.0001)). Cohen's d was -0.86, indicating a strong clinical effect. The effect was supported by secondary outcomes. CONCLUSION: Cognitive behavioural therapy provided by cardiac nurses to patients with a positive screening for anxiety had a statistically and clinically significant effect on anxiety compared with patients not receiving cognitive behavioural therapy.

Subgroup Differences and Determinants of Patient-Reported Mental and Physical Health in Patients With Ischemic Heart Disease: Results From the DenHeart Study.

BACKGROUND: A growing population is living with ischemic heart disease (IHD). Patient-reported outcomes (PROs) are reliable prognostic tools. Studies exploring PROs are needed to identify vulnerable patients and guide targeted healthcare strategies. OBJECTIVES: The aims of this study were to (i) describe PROs at hospital discharge across 3 diagnostic subgroups: (1) chronic IHD/stable angina, (2) non-ST-elevation myocardial infarction (non-STEMI)/unstable angina, and (3) ST-elevation myocardial infarction (STEMI), and (ii) examine determinants for PROs at hospital discharge in patients with IHD. METHODS: This study included a national cohort with register-data linkage including 14 115 adults with IHD discharged from Danish heart centers. Eligible patients (n = 13 476) were invited to complete a questionnaire, and 7 167 (53%) responded. Questionnaires included the Medical Outcome Study Short-Form 12, the Hospital Anxiety and Depression Scale, EuroQoL, HeartQoL, the Edmonton Symptom Assessment Scale, and ancillary questions. Sociodemographic and clinical characteristics were obtained from national registers. Student t test, χ test, and adjusted linear and logistic regression analyses were conducted to investigate subgroup differences, and adjusted linear and logistic regression analyses were conducted to explore determinants for PROs. RESULTS: Statistically significant subgroup differences were found, with groups reporting worst to best scores for most of PROs being as follows: chronic IHD/stable angina, non-STEMI/unstable angina, and STEMI. Symptoms of anxiety were highly prevalent in the non-STEMI/unstable angina group, with 33.8% exceeding a Hospital Anxiety and Depression Scale-Anxiety cutoff score indicating a possible anxiety disorder. Determinants for worse PROs included female sex, lower educational level, obesity, and poor physical fitness. CONCLUSIONS: Significant differences in PROs across IHD subgroups were observed and determinants for poor outcomes suggested. Results may guide differentiated care initiatives and resource allocation for preventative strategies.

Do patients with ICD who report anxiety symptoms on Hospital Anxiety and Depression Scale suffer from anxiety?

OBJECTIVES: The objectives were to determine: 1) whether patients with an implantable cardioverter defibrillator (ICD) presenting with anxiety symptoms measured on the Hospital Anxiety and Depression Scale (HADS) have identifiable anxiety according to the Structured Clinical Interview for DSM disorders (SCID) and 2) the type of anxiety, if any, behind a HADS-A score ≥ 8 in patients with an ICD. METHODS: Patients with an ICD were screened using HADS and patients with a HADS-A score ≥ 8 were invited to participate. A total of 88 patients were included in the study and were interviewed using the SCID instrument to determine anxiety or adjustment disorder. RESULTS: A total of 56% met the criteria for an anxiety diagnosis, 20% for adjustment disorder with anxiety and 8% for adjustment disorder without anxiety. Frequent types of anxiety were panic disorder, generalized anxiety disorder (GAD) and post-traumatic stress disorder (PTSD). Furthermore, 24 (28%) had an adjustment disorder. CONCLUSION: A total of 84% meet the criteria for anxiety or adjustment disorder. The most common anxiety diagnoses were panic disorder, GAD and PTSD.

The Screen-ICD trial. Screening for anxiety and cognitive therapy intervention for patients with implanted cardioverter defibrillator (ICD): a randomised controlled trial protocol.

INTRODUCTION: Previous research shows that patients with an implanted cardioverter defibrillator (ICD) have a fourfold increased mortality risk when suffering from anxiety compared with ICD patients without anxiety. This research supports the screening of ICD patients for anxiety with the purpose of starting relevant intervention. METHODS AND ANALYSIS: Screen-ICD consists of 3 parts: (1) screening of all hospitalised and outpatient patients at two university hospitals using the Hospital Anxiety and Depression Scale (HADS), scores ≥8 are invited to participate. (2) Assessment of type of anxiety by Structured Clinical Interview for DSM Disorders (SCID). (3) Investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive-behavioural therapy (CBT) performed by a cardiac nurse with CBT training, plus usual care or usual care alone. The primary outcome is HADS-A measured at 16 weeks. Secondary outcomes include Becks Anxiety Inventory, HeartQoL, Hamilton Anxiety Scale, heart rate variability, ICD shock, time to first shock and antitachycardia pacing. A total of 88 participants will be included. The primary analyses are based on the intention-to-treat principle and we use a mixed model with repeated measurements for continuous outcomes. For binary outcomes (HADS-A score <8), we use a generalised mixed model with repeated measurements. ETHICS AND DISSEMINATION: The trial is performed in accordance with the Declaration of Helsinki. All patients must give informed consent prior to participation and the trial is initiated after approval by the Danish Data Protection Agency (RH-2015-282) and the regional ethics committee (H-16018868). Positive, neutral and negative results of the trial will be published. TRIAL REGISTRATION NUMBER: NCT02713360.

Patient-reported outcomes at hospital discharge from Heart Centres, a national cross-sectional survey with a register-based follow-up: the DenHeart study protocol.

INTRODUCTION: Patient reported health status, which includes symptom burden, functional status and quality of life, is an important measure of health. Differences in health status between diagnostic groups within cardiology have only been sparsely investigated. These outcomes may predict morbidity, mortality, labour market affiliation and healthcare utilisation in various diagnostic groups. A national survey aiming to include all cardiac diagnostic groups from a total Heart Centre population has been designed as the DenHeart survey. METHODS AND ANALYSIS: DenHeart is designed as a cross-sectional survey with a register-based follow-up. All diagnostic groups at the five national Heart Centres are included during 1 year (15 April 2013 to 15 April 2014) and asked to fill out a questionnaire at hospital discharge. The total eligible population, both responders and non-responders, will be followed in national registers. The following instruments are used: SF-12, Hospital Anxiety and Depression Scale, EQ-5D, Brief Illness Perception Questionnaire (B-IPQ), HeartQoL and Edmonton Symptom Assessment Scale. The following variables are collected from national registers: action diagnosis, procedures, comorbidity, length of hospital stay, type of hospitalisation, visits to general practitioners and other agents in primary healthcare, dispensed prescription medication, vital status and cause of death. Labour market affiliation, sick leave, early retirement pension, educational degree and income will be collected from registers. Frequency distributions and multiple logistic regression analyses will be used to describe and assess differences in patient reported outcomes at hospital discharge between diagnostic groups and in-hospital predicting factors. Cox proportional hazards regression models with age as the time scale will be used to investigate associations between patient reported outcomes at baseline and morbidity/mortality, labour market affiliation and healthcare utilisation after 1 year. ETHICS AND DISSEMINATION: The study complies with the Declaration of Helsinki. The study has been approved by the Danish Data Protection Agency: 2007-58-0015/30-0937 and registered at ClinicalTrials.gov (NCT01926145). Study findings will be disseminated widely through peer reviewed publications and conference presentations.

Constipation--prevalence and incidence among medical patients acutely admitted to hospital with a medical condition.

AIMS AND OBJECTIVES: To examine the prevalence and incidence of patient-reported symptoms of constipation in acutely hospitalised medical patients. BACKGROUND: Constipation is a common medical problem with severe consequences, and most people suffer from constipation at some point in their lives. In the general population, constipation is one of the most common complaints and is a significant personal and public health burden. Alteration in patients' patterns of elimination while in hospital has long been identified as either a potential or an actual problem that requires attention. Knowledge of the prevalence and incidence of constipation during hospitalisation is only sporadic. DESIGN: The study was descriptive and a prospective cohort design was chosen. METHODS: The Constipation Assessment Scale was translated into Danish and was used for the assessment of patient-reported bowel function. Five nurses made the assessments at admission to the acute medical ward and three days after admission. Three hundred and seventy-three patients participated in this study. RESULTS: Thirty-nine percent of the patients showed symptoms of constipation at admission. Of the patients who did not have the symptoms at admission, 43% developed the symptoms during the first three days of their stay in hospital. Significantly more of the older patients developed symptoms of moderate constipation. The incidence rate was 143 new cases per 1000 patient days. CONCLUSIONS: In this study, symptoms of constipation were common among patients acutely admitted to hospital due to different medical conditions. Symptoms of constipation were also developed during the first three days of the stay in hospital. RELEVANCE TO CLINICAL PRACTICE: The study highlights the need to develop both clinical guidelines towards treating constipation, and preventive measures to ensure that patients do not become constipated while staying in hospital.

Women's experiences of sexual health after first-time myocardial infarction.

AIMS AND OBJECTIVES: To investigate women's experience of sexual problems after a myocardial infarction. BACKGROUND: Sexual problems among female patients with ischaemic heart disease have received little study but have been found to be highly prevalent in the research. Sexual problems have been found to influence quality of life and well-being, and sexual dysfunction has been associated with anxiety and depression. International guidelines recommend that healthcare professionals address sexuality; however, this is rarely done in practice, due to multiple causes, for example ignorance, embarrassment and lack of systematic treatment. Insight into women's sexual challenges after having a myocardial infarction is much needed. DESIGN: Qualitative interview study. METHODS: Qualitative interviews were conducted with 11 patients representative of the population and later transcribed. The analysis was inspired by Ricoeur's theory of interpretation, which consists of three levels: naive reading, structured analysis, and critical interpretation and discussion. RESULTS: The overall finding that emerged regarding the women's sexual health was an anxious resuming of sexual activity. Four themes emerged: (1) the partner, (2) support, (3) the heart disease's influence on sex and (4) the relationship. CONCLUSION: The women experienced anxious resuming of sexual activity. The heart disease had influence on their sex life, and relationship with their partner could be affected. Some needed support from health professionals or their network to dare sexual activity again. RELEVANCE TO CLINICAL PRACTICE: This study indicates that health professionals should focus more on identifying anxiety and exhaustion after myocardial infarction and articulating their potential influence on women's sexual lives. Whether this should be addressed in the hospital setting, in the phase 2 rehabilitation at the general practitioner level or in combination has to be considered and may be the basis for further research.

Women's experiences and behaviour at onset of symptoms of ST segment elevation acute myocardial infarction.

BACKGROUND: Minimizing time from onset of symptoms to treatment (treatment delay) is crucial for patients with ST segment elevation acute myocardial infarction (STEMI), and one of the great challenges is to reduce the delay relating to the prehospital behaviour of the patient (patient delay). Studies indicate that women delay longer than men and insights into this area could lead to improved health education programmes aimed at reducing patient delay in women with STEMI. METHOD: Open interviews with 14 women with STEMI were held during their hospital stay from June to September 2009. The interviews were aimed at exploring determinants of treatment delay, and were carried out and analysed within a phenomenological framework. FINDINGS: Three themes emerged important for the delay in seeking medical assistance: (1) Knowledge and ideas of AMI symptoms and risks. (2) Ambivalence whether to call for medical assistance or to cope with the situation. (3) Actions and strategies taken after onset of symptoms. CONCLUSIONS: Three factors determined whether women showed appropriate behaviour for reduced patient delay after onset of symptoms: (1) identifying the symptoms as being of cardiac origin, (2) having a prepared action plan in case of an emergency situation, and (3) living with someone or contacting other persons.

Long-term global and regional brain volume changes following severe traumatic brain injury: a longitudinal study with clinical correlates.

Traumatic brain injury (TBI) results in neurodegenerative changes that progress for months, perhaps even years post-injury. However, there is little information on the spatial distribution and the clinical significance of this late atrophy. In 24 patients who had sustained severe TBI we acquired 3D T1-weighted MRIs about 8 weeks and 12 months post-injury. For comparison, 14 healthy controls with similar distribution of age, gender and education were scanned with a similar time interval. For each subject, longitudinal atrophy was estimated using SIENA, and atrophy occurring before the first scan time point using SIENAX. Regional distribution of atrophy was evaluated using tensor-based morphometry (TBM). At the first scan time point, brain parenchymal volume was reduced by mean 8.4% in patients as compared to controls. During the scan interval, patients exhibited continued atrophy with percent brain volume change (%BVC) ranging between -0.6% and -9.4% (mean -4.0%). %BVC correlated significantly with injury severity, functional status at both scans, and with 1-year outcome. Moreover, %BVC improved prediction of long-term functional status over and above what could be predicted using functional status at approximately 8 weeks. In patients as compared to controls, TBM (permutation test, FDR 0.05) revealed a large coherent cluster of significant atrophy in the brain stem and cerebellar peduncles extending bilaterally through the thalamus, internal and external capsules, putamen, inferior and superior longitudinal fasciculus, corpus callosum and corona radiata. This indicates that the long-term atrophy is attributable to consequences of traumatic axonal injury. Despite progressive atrophy, remarkable clinical improvement occurred in most patients.

Diffusion tensor imaging during recovery from severe traumatic brain injury and relation to clinical outcome: a longitudinal study.

Diffusion tensor imaging (DTI) has been proposed as a sensitive biomarker of traumatic white matter injury, which could potentially serve as a tool for prognostic assessment and for studying microstructural changes during recovery from traumatic brain injury (TBI). However, there is a lack of longitudinal studies on TBI that follow DTI changes over time and correlate findings with long-term clinical outcome. We performed a prospective longitudinal study of 30 adult patients admitted for subacute rehabilitation following severe traumatic brain injury. DTI and conventional MRI were acquired at mean 8 weeks (5-11 weeks), and repeated in 23 of the patients at mean 12 months (9-15 months) post-trauma. Using a region-of-interest-based approach, DTI parameters were compared to those of healthy matched controls, scanned during the same time period and rescanned with a similar interval as that of patients. At the initial scan, fractional anisotropy was reduced in all the investigated white matter regions in patients compared to controls (P

Unilateral ocular duplication.

PURPOSE: To present a boy with unilateral duplication of the eye. METHOD: The case history is described from the first visit at birth to the age of 14 years. RESULTS: A review of the literature shows that this malformation is compatible with life although malformations of the brain and epilepsy have been reported in all cases where a paediatric exam was described. We show that the malformation can appear as a synophthalmic eye in a single orbit or as two separate unilateral eyes in a separate orbit. CONCLUSION: We find the denomination, triophthalmia insufficient to differentiate between the two types and suggest a differentiation between unilateral synophthalmia and ipsilateral ocular duplication.

[Magnetic resonance imaging in severe traumatic brain injury]. / Magnetisk resonans-skanning ved svaer traumatisk hjerneskade.

Modern neuroimaging techniques are continuously improving the diagnostic and prognostic assessment of patients with traumatic brain injury. The rapid developments within the field of magnetic resonance imaging (MRI) in particular provide several complementary tools for evaluating structural and functional changes in the injured brain. This article summarizes the current clinical use and future potential of the main structural and functional MRI techniques in the evaluation of severe non-missile head injury in the subacute phase.

Source analysis of epileptic discharges using multiple signal classification analysis.

Multiple signal classification is an alternative to the traditional dipole fitting source analysis methods. Our aim was to assess the clinical usefulness of this algorithm and to compare the localization of the epileptiform electroencephalography discharges with the regions of altered cerebral blood flow in 10 patients with complex partial seizures undergoing preoperative investigation. We performed multiple signal classification analysis of ictal and interictal discharges, and registered single-photon emission computed tomography. Localization of the ictal, but not the interictal discharges, as determined by multiple signal classification analysis was consistent with the regions showing perfusion changes on the single-photon emission computed tomography. Multiple signal classification analysis is a promising tool in localizing foci in patients with complex partial seizures and may contribute to the preoperative evaluation.