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1.
Stroke ; 55(4): 874-879, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38299363

ABSTRACT

BACKGROUND: Remote ischemic conditioning (RIC) is a simple and noninvasive procedure that has proved to be safe and feasible in numerous smaller clinical trials. Mixed results have been found in recent large randomized controlled trials. This is a post hoc subgroup analysis of the RESIST trial (Remote Ischemic Conditioning in Patients With Acute Stroke), investigating the effect of RIC in different acute ischemic stroke etiologies, and whether an effect was modified by treatment adherence. METHODS: Eligible patients were adults (aged ≥18 years), independent in activities of daily living, who had prehospital stroke symptoms with a duration of less than 4 hours. They were randomized to RIC or sham. The RIC treatment protocol consisted of 5 cycles with 5 minutes of cuff inflation alternating with 5 minutes with a deflated cuff. Acceptable treatment adherence was defined as when at least 80% of planned RIC cycles were received. The analysis was performed using the entire range (shift analysis) of the modified Rankin Scale (ordinal logistic regression). RESULTS: A total of 698 had acute ischemic stroke, 253 (36%) were women, and the median (interquartile range) age was 73 (63-80) years. Median (interquartile range) overall adherence to RIC/sham was 91% (68%-100%). In patients with a stroke due to cerebral small vessel disease, who were adherent to treatment, RIC was associated with improved functional outcome, and the odds ratio for a shift to a lower score on the modified Rankin Scale was 2.54 (1.03-6.25); P=0.042. The association remained significant after adjusting for potential confounders. No significant associations were found with other stroke etiologies, and the overall test for interaction was not statistically significant (χ2, 4.33, P=0.23). CONCLUSIONS: In patients with acute ischemic stroke due to cerebral small vessel disease, who maintained good treatment adherence, RIC was associated with improved functional outcomes at 90 days. These results should only serve as a hypothesis-generating for future trials. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03481777.


Subject(s)
Cerebral Small Vessel Diseases , Ischemic Preconditioning , Ischemic Stroke , Stroke , Adult , Humans , Female , Adolescent , Aged , Aged, 80 and over , Male , Ischemic Preconditioning/methods , Activities of Daily Living , Stroke/therapy , Treatment Outcome , Randomized Controlled Trials as Topic
2.
Scand Cardiovasc J ; 58(1): 2373085, 2024 Dec.
Article in English | MEDLINE | ID: mdl-38957077

ABSTRACT

Objectives. The prevalence of patients with prior stroke is increasing globally. Accordingly, there is a need for up-to-date evidence of patient-related prognostic factors for stroke recurrence, post stroke myocardial infarction (MI) and death based on long-term follow-up of stroke survivors. For this purpose, the RIALTO study was established in 2004. Design. A prospective cohort study in which patients diagnosed with ischemic stroke (IS) or transient ischemic attack (TIA) in three Copenhagen hospitals were included. Data were collected from medical records and by structured interview. Data on first stroke recurrence, first MI and all-cause death were extracted from the Danish National Patient Registry and the Danish Civil Registration System. Results. We included 1215 patients discharged after IS or TIA who were followed up by register data from April 2004 to end of 2018 giving a median follow-up of 3.5-6.9 years depending on the outcome. At the end of follow-up 406 (33%) patients had been admitted with a recurrent stroke, 100 (8%) had a MI and 822 (68%) had died. Long-term prognostic predictors included body mass index, diabetes, antihypertensive and lipid lowering treatment, smoking, a sedentary lifestyle as well as poor self-rated health and psychosocial problems. Conclusions. Long-term risk of recurrent stroke and MI remain high in patients discharged with IS or TIA despite substantial improvements in tertiary preventive care in recent decades. Continued attention to the patient risk profile among patients surviving the early phase of stroke, including comorbidities, lifestyle, and psychosocial challenges, is warranted.


Subject(s)
Ischemic Attack, Transient , Ischemic Stroke , Myocardial Infarction , Patient Discharge , Recurrence , Registries , Humans , Male , Female , Ischemic Attack, Transient/mortality , Ischemic Attack, Transient/diagnosis , Ischemic Attack, Transient/epidemiology , Aged , Myocardial Infarction/mortality , Myocardial Infarction/diagnosis , Myocardial Infarction/epidemiology , Denmark/epidemiology , Risk Factors , Time Factors , Middle Aged , Prospective Studies , Risk Assessment , Ischemic Stroke/mortality , Ischemic Stroke/diagnosis , Ischemic Stroke/epidemiology , Prognosis , Aged, 80 and over , Cause of Death
3.
Scand J Public Health ; : 14034948231205822, 2024 Jan 05.
Article in English | MEDLINE | ID: mdl-38179955

ABSTRACT

BACKGROUND: Atrial fibrillation and flutter (AF) is the most common sustained arrhythmia with an increasing prevalence in Western countries. However, little is known about AF among immigrants compared to non-immigrants. AIM: To examine the incidence of hospital-diagnosed AF according to country of origin. METHOD: Immigrants were defined as individuals born outside Denmark by parents born outside Denmark. AF was defined as first-time diagnosis of AF. All individuals were followed from the age of 45 years from 1998 to 2017. The analyses were adjusted for sex, age, comorbidity, contact with the general practitioner and socioeconomic variables. Adjustment was conducted using standardised morbidity ratio weights, standardised to the Danish population in a marginal structural model. RESULTS: The study population consisted of 3,489,730 Danish individuals free of AF and 108,914 immigrants free of AF who had emigrated from the 10 most represented countries. A total of 323,005 individuals of Danish origin had an incident hospital diagnosis of AF, among the immigrants 7,300 developed AF. Adjusted hazard rate ratios (HRRs) of AF for immigrants from Iran (0.48 [95%CI:0.35;0.64]), Turkey (0.74 [95%CI:0.67;0.82]) and Bosnia-Herzegovina (0.42 [95%CI:0.22;0.79]) were low compared with Danish individuals. Immigrants from Sweden, Germany and Norway had an adjusted HRR of 1.13 [95%CI:1.03;1.23], 1.12 [95%CI:1.05;1.18] and 1.11 [95%CI:1.03;1.21], respectively (Danish individuals as reference). CONCLUSIONS: Substantial variation in the incidence of hospital-diagnosed AF according to country of origin was observed. The results may reflect true biological differences but could also reflect barriers to AF diagnosis for immigrants. Further efforts are warranted to determine the underlying mechanisms.

4.
Eur J Neurosci ; 58(4): 3116-3131, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37442794

ABSTRACT

Multinomial logistic regression (MLR) is often used to model the association between a nominal outcome variable and one or more covariates. The results of MLR are interpreted as relative risk ratios (RRR) and warrant a more coherent interpretation than ordinary logistic regression. Some authors compare the results of MLR to ordinal logistic regression (OLR), irrespective of the fact that these estimate different quantities. We aim to investigate the time trends in the use and misuse of MLR in studies including stroke patients, specifically the extent to which (1) the results are denoted as anything other than RRR, (2) comparisons are made of results with results of OLR and (3) results have been interpreted coherently. Secondarily, we examine the use of model validation techniques in studies with predictive aims. We searched EMBASE and PubMed for articles using MLR on populations of stroke patients. Identified studies were screened, and information pertaining to our aims was extracted. A total of 285 articles were identified through a systematic literature search, and 68 of these were included in the review. Of these, 60 articles (88%) did not denote exponentiated coefficients of MLR as relative risk ratios but rather some other measure. Additionally, 63 articles (93%) interpreted the results of MLR in a non-coherent manner. Two articles attempted to compare MLR results with those of OLR. Nine studies attempted to use MLR for predictive means, and three used relevant validation techniques. From these findings, it is clear that the interpretation of MLR is often suboptimal.

5.
Am Heart J ; 262: 100-109, 2023 08.
Article in English | MEDLINE | ID: mdl-37116603

ABSTRACT

BACKGROUND: Severe chronic obstructive pulmonary disease (COPD) has been associated with futile outcome after transcatheter aortic valve replacement (TAVR). Data on outcomes according to COPD severity are warranted to aid identification of patients who may not benefit from TAVR. We aimed to examine the association between risk of COPD exacerbation and 1-year mortality after TAVR. METHODS: Using Danish nationwide registries we identified patients undergoing first-time TAVR during 2008-2021 by COPD status. COPD severity levels were defined as low or high risk of acute exacerbation of COPD (AE-COPD) and treatment intensity levels (none or short-term, mono/dual, triple therapy, or home oxygen). Kaplan-Meier functions and adjusted Cox regression models were used to assess 1-year mortality comparing COPD severity groups with patients without COPD. RESULTS: We identified 7,047 patients with TAVR of whom 644 had a history of COPD (low risk of AE-COPD: 439, high risk of AE-COPD: 205). The median age of the TAVR cohort was 81.4 years (IQR: 76.8-85.1) and 55.8% were males. One-year mortality for TAVR patients without COPD was 8.5% (95% CI: 7.8-9.2) and 15.4% (95% CI: 12.5-18.2) for those with COPD (adjusted HR: 1.63 [95% CI: 1.28-2.07]). Patients with low or high risk of AE-COPD had 1-year mortality of 13.1% (95% CI: 9.8-16.3) and 20.2% (95% CI: 14.6-25.8) corresponding to adjusted HRs of 1.31 (95% CI: 0.97-1.78) and 2.44 (95% CI: 1.70-3.50) compared with patients without COPD. Patients with high risk of AE-COPD and no/short term therapy or use of home oxygen represented the subgroups of patients with the highest 1-year mortality (31.6% [95% CI: 14.5-48.7] and 30.9% [95% CI: 10.3-51.6]). CONCLUSION: Among patients undergoing TAVR, increasing risk of exacerbation with COPD was associated with increasing 1-year mortality compared with non-COPD patients. Patients with a high risk of exacerbation with COPD not using any guideline recommended COPD medication and those using home oxygen had the highest 1-year mortality.


Subject(s)
Aortic Valve Stenosis , Pulmonary Disease, Chronic Obstructive , Transcatheter Aortic Valve Replacement , Male , Humans , Aged , Aged, 80 and over , Female , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome , Aortic Valve Stenosis/complications , Pulmonary Disease, Chronic Obstructive/complications , Pulmonary Disease, Chronic Obstructive/epidemiology , Oxygen , Risk Factors , Aortic Valve/surgery , Severity of Illness Index , Registries
6.
Gynecol Oncol ; 172: 1-8, 2023 05.
Article in English | MEDLINE | ID: mdl-36905767

ABSTRACT

OBJECTIVE: To examine hospital-based specialist palliative care (SPC) utilisation among patients with gynaecological cancer, including temporal trends, predictors and associations with high-intensity end-of-life care. METHODS: We conducted a nationwide registry-based study for all patients dying from gynaecological cancer in Denmark during 2010-2016. We estimated the proportions of patients receiving SPC by year of death and used regression analyses to examine predictors of SPC utilisation. Use of high-intensity end-of-life care according to SPC utilisation was compared by regression analyses adjusting for type of gynaecological cancer, year of death, age, comorbidities, residential region, marital/cohabitation status, income level and migrant status. RESULTS: Among 4502 patients dying from gynaecological cancer, the proportion of patients receiving SPC increased from 24.2% in 2010 to 50.7% in 2016. Young age, three or more comorbidities, residence outside the Capital Region and being immigrant/descendant were associated with increased SPC utilisation, whereas income, cancer type and stage were not. SPC was associated with lower high-intensity end-of-life care utilisation. Particularly, when compared with patients not receiving SPC, patients who accessed SPC >30 days before death had 88% lower risk of intensive care unit admissions within 30 days before death (adjusted relative risk: 0.12 (95% CI: 0.06; 0.24)) and 96% lower risk of surgery within 14 days before death (adjusted relative risk: 0.04 (95% CI: 0.01; 0.31)). CONCLUSIONS: Among patients dying from gynaecological cancer, SPC utilisation increased over time and age, comorbidities, residential region and migrant status were associated with access to SPC. Furthermore, SPC was associated with lower use of high-intensity end-of-life care.


Subject(s)
Genital Neoplasms, Female , Hospice Care , Neoplasms , Terminal Care , Female , Humans , Palliative Care , Genital Neoplasms, Female/therapy , Hospitals
7.
Cerebrovasc Dis ; 52(3): 275-282, 2023.
Article in English | MEDLINE | ID: mdl-36315990

ABSTRACT

INTRODUCTION: We aimed to determine the treatment delay for ischemic stroke patients in Denmark. METHODS: A nationwide register-based study on acute ischemic stroke patients admitted through emergency medical services. Treatment delay comprised patient, prehospital, and in-hospital delay. Analyses were stratified according to length of prehospital delay (<3 vs. ≥3 h). RESULTS: A total of 5,356 ischemic stroke episodes were included. The median onset-to-door time was 187 min, and 2,405 (43%) arrived at the stroke unit within 3 h. Overall, the median patient delay was 115 min. For early arrival (n = 2,280), patient delay was 27 min compared to 437 min for late arrivals (n = 2,448). Median prehospital delay varied by 9 min between early- and late-arriving patients. Approximately 48% of the early-arriving patients compared to 9% of the late-arriving patients received i.v. thrombolysis. For thrombectomy, the numbers were 10% and 3%, respectively. This corresponded to an unadjusted relative risk (RR) of 0.18 (95% CI: 0.16-0.21) and adjusted (age, sex, cohabitation status, and stroke severity) RR of 0.20 (95% CI: 0.18-0.23) for i.v. thrombolysis when comparing patients arriving later than 3 h with patients arriving earlier. For thrombectomy, the unadjusted and adjusted RRs were 0.30 (95% CI: 0.23-0.39) and 0.40 (95% CI: 0.31-0.52), respectively. CONCLUSIONS: Patient delay remains the most important barrier for use of reperfusion therapy among acute ischemic stroke patients calling 1-1-2, whereas system delay seems independent of patient delay.


Subject(s)
Emergency Medical Services , Ischemic Stroke , Stroke , Humans , Time-to-Treatment , Thrombolytic Therapy/adverse effects , Stroke/therapy , Stroke/drug therapy , Reperfusion , Denmark , Treatment Outcome
8.
Colorectal Dis ; 25(1): 31-43, 2023 01.
Article in English | MEDLINE | ID: mdl-36031925

ABSTRACT

AIM: To (1) develop an assessment tool for laparoscopic complete mesocolic excision (LCME) and (2) report evidence of its content validity. METHOD: Assessment statements were revealed through (1) semi-structured expert interviews and (2) consensus by the Delphi method, both involving an expert panel of five LCME surgeons. All experts were interviewed and then asked to rate LCME describing statements from 1 (strongly disagree) to 5 (strongly agree). Responses were returned anonymously to the panel until consensus was reached. Statements were directly included as content in the assessment tool if ≥60% of the experts responded "agree" or "strongly agree" (ratings 4 and 5), with the remaining responses being "neither agree nor disagree" (rating 3). Interclass correlation coefficient (ICC) was calculated for expert agreement evaluation. All included statements were subsequently reformulated as tool items and approved by the experts. RESULTS: Four Delphi rounds were performed to reach consensus. Disagreement was reported for statements describing instrument handling around pancreas; visualisation of landmarks before inferior mesenteric artery ligation; lymphadenectomy around the inferior mesenteric artery, and division of the terminal ileum and transverse colon. ICC in the last Delphi-round was 0.84. The final tool content included 73 statements, converted to 48 right- and 40 left-sided items for LCME assessment. CONCLUSION: A procedure-specific, video-based tool, named complete mesocolic excision competency assessment tool (CMECAT), has been developed for LCME skill assessment. In the future, we hope it can facilitate assessment of LCME surgeons, resulting in improved patient outcome after colon cancer surgery.


Subject(s)
Colon, Transverse , Colonic Neoplasms , Laparoscopy , Humans , Laparoscopy/methods , Colonic Neoplasms/surgery , Colon, Transverse/surgery , Lymph Node Excision/methods , Ligation , Delphi Technique
9.
Colorectal Dis ; 25(11): 2139-2146, 2023 11.
Article in English | MEDLINE | ID: mdl-37776110

ABSTRACT

AIM: The complete mesocolic excision competency assessment tool (CMECAT) is a novel tool designed to assess technical skills in minimally invasive complete mesocolic excision (CME) surgery. The aim of this study was to assess construct validity and reliability of CMECAT in a clinical context. METHOD: Colorectal surgeons were asked to submit video recorded laparoscopic CME resections for independent assessment of their technical abilities. The videos were grouped by surgeons' training level, and four established CME experts were recruited as CMECAT assessors. Extended reliability analysis (G-theory) was applied to describe assessor agreement. RESULTS: A total of 19 videos and 72 assessments were included in the analysis. Overall, technical skills assessed by CMECAT improved with increased training level: the experts scored significantly better than the untrained surgeons (3.3 vs. 2.5 points; p < 0.01). On right-sided resections, significantly higher scores were reported with increased training level for all categories and sections, while for left-sided resections, the variance across groups was smaller and significantly higher scores were only reported for oncological safety describing items. Overall, assessor agreement was high (G-coefficient: 0.81). CONCLUSION: This study confirms that CMECAT can be applied to video recorded CME cases for technical skill assessment. Further, it can reliably assess technical performance in right sided CME surgery, where construct validity has now been established. More videos are required to evaluate its validity on left colonic CME. In the future, we hope CMECAT can improve feedback during CME training, serve as a tool in certification processes and contribute to distinguishing CME from conventional surgery in future research.


Subject(s)
Colonic Neoplasms , Laparoscopy , Mesocolon , Humans , Lymph Node Excision , Colonic Neoplasms/surgery , Reproducibility of Results , Mesocolon/surgery , Colectomy , Treatment Outcome
10.
JAMA ; 330(13): 1236-1246, 2023 10 03.
Article in English | MEDLINE | ID: mdl-37787796

ABSTRACT

Importance: Despite some promising preclinical and clinical data, it remains uncertain whether remote ischemic conditioning (RIC) with transient cycles of limb ischemia and reperfusion is an effective treatment for acute stroke. Objective: To evaluate the effect of RIC when initiated in the prehospital setting and continued in the hospital on functional outcome in patients with acute stroke. Design, Setting, and Participants: This was a randomized clinical trial conducted at 4 stroke centers in Denmark that included 1500 patients with prehospital stroke symptoms for less than 4 hours (enrolled March 16, 2018, to November 11, 2022; final follow-up, February 3, 2023). Intervention: The intervention was delivered using an inflatable cuff on 1 upper extremity (RIC cuff pressure, ≤200 mm Hg [n = 749] and sham cuff pressure, 20 mm Hg [n = 751]). Each treatment application consisted of 5 cycles of 5 minutes of cuff inflation followed by 5 minutes of cuff deflation. Treatment was started in the ambulance and repeated at least once in the hospital and then twice daily for 7 days among a subset of participants. Main Outcomes and Measures: The primary end point was improvement in functional outcome measured as a shift across the modified Rankin Scale (mRS) score (range, 0 [no symptoms] to 6 [death]) at 90 days in the target population with a final diagnosis of ischemic or hemorrhagic stroke. Results: Among 1500 patients who were randomized (median age, 71 years; 591 women [41%]), 1433 (96%) completed the trial. Of these, 149 patients (10%) were diagnosed with transient ischemic attack and 382 (27%) with a stroke mimic. In the remaining 902 patients with a target diagnosis of stroke (737 [82%] with ischemic stroke and 165 [18%] with intracerebral hemorrhage), 436 underwent RIC and 466 sham treatment. The median mRS score at 90 days was 2 (IQR, 1-3) in the RIC group and 1 (IQR, 1-3) in the sham group. RIC treatment was not significantly associated with improved functional outcome at 90 days (odds ratio [OR], 0.95; 95% CI, 0.75 to 1.20, P = .67; absolute difference in median mRS score, -1; -1.7 to -0.25). In all randomized patients, there were no significant differences in the number of serious adverse events: 169 patients (23.7%) in the RIC group with 1 or more serious adverse events vs 175 patients (24.3%) in the sham group (OR, 0.97; 95% CI, 0.85 to 1.11; P = .68). Upper extremity pain during treatment and/or skin petechia occurred in 54 (7.2%) in the RIC group and 11 (1.5%) in the sham group. Conclusions and Relevance: RIC initiated in the prehospital setting and continued in the hospital did not significantly improve functional outcome at 90 days in patients with acute stroke. Trial Registration: ClinicalTrials.gov Identifier: NCT03481777.


Subject(s)
Ischemia , Ischemic Postconditioning , Stroke , Aged , Female , Humans , Cerebral Hemorrhage/etiology , Cerebral Hemorrhage/therapy , Ischemic Attack, Transient/therapy , Ischemic Stroke/therapy , Stroke/therapy , Ischemic Postconditioning/methods , Extremities/blood supply , Recovery of Function , Denmark , Hemorrhagic Stroke/therapy
11.
Nord J Psychiatry ; 77(2): 188-197, 2023 Feb.
Article in English | MEDLINE | ID: mdl-35697087

ABSTRACT

BACKGROUND: Insomnia in depression is common and difficult to resolve. Unresolved depression-related sleep disturbances increase risk of relapse at high costs for individuals and society. Trials have suggested music for insomnia in various populations, but there is little research on the effectiveness of music for depression-related insomnia. METHODS: We examined the efficacy of a music intervention on insomnia, depression symptoms and quality of life in adults with depression-related insomnia. A two-armed randomized controlled trial was conducted, including depression outpatients with insomnia (n = 112) in a 1:1 ratio to music intervention and waitlist control group. The intervention group listened to music at bedtime for 4 weeks. Participants received treatment as usual during 8 weeks with assessments at baseline, at 4 and 8 weeks. The primary outcome measure was Pittsburgh Sleep Quality Index (PSQI), secondary outcomes comprised Actigraphy, the Hamilton Depression Rating Scale (HAMD-17) and World Health Organisation well-being questionnaires (WHO-5, WHOQOL-BREF). RESULTS: The music intervention group experienced significant improvements in sleep quality and well-being at 4 weeks according to global PSQI scores (effect size = -2.1, 95%CI -3.3; -0.9) and WHO-5 scores (effect size 8.4, 95%CI 2.7;14.0). At 8 weeks, i.e. 4 weeks after termination of the music intervention, the improvement in global PSQI scores had decreased (effect size = -0.1, 95%CI -1.3; 1.1). Actigraphy sleep assessments showed no changes and there was no detection of change in depression symptoms. CONCLUSIONS: Music intervention is suggested as a safe and moderately effective sleep aid in depression-related insomnia. Trial registration: Clinicaltrials.gov. ID NCT03676491.


Subject(s)
Music , Sleep Initiation and Maintenance Disorders , Humans , Adult , Sleep Initiation and Maintenance Disorders/etiology , Sleep Initiation and Maintenance Disorders/therapy , Sleep Quality , Depression/etiology , Depression/therapy , Quality of Life , Sleep , Treatment Outcome
12.
Am Heart J ; 243: 28-38, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34537184

ABSTRACT

BACKGROUND: The prevalence of atrial fibrillation (AF) is increasing globally, which is a major clinical and public health concern due to the 5-fold increased risk of stroke. Oral anticoagulation with novel oral anticoagulants (NOACs) is the current primary option for stroke prevention in patients with AF, although it increases the risk of major bleeding. Patients with prior ischemic cerebrovascular events are at particularly high risk of both recurrent ischemic events and major bleeding. Left atrial appendage occlusion (LAAO) provides an alternative option for stroke prevention in high-risk patients, however, with currently limited evidence. Thus, randomized trials comparing LAAO to NOACs are needed. OBJECTIVE: The Occlusion-AF trial is designed to assess whether LAAO is non-inferior to NOAC therapy for reduction of the combined endpoint of stroke, systemic embolism, major bleeding (Bleeding Academic Research Consortium ≥ 3) and all-cause mortality in patients with AF and a recent ischemic stroke or transient ischemic attack (TIA). METHODS AND ANALYSIS: Investigator-initiated multicenter, multinational, randomized open-label non-inferiority trial with blinded outcome evaluation (PROBE design). Patients with documented AF, and an ischemic stroke or TIA within 6 months will be eligible for enrollment. Major exclusion criteria are modified Rankin Scale > 3 at enrollment, glomerular filtration rate < 15 ml/min, and life-expectancy less than 2 years. A total of 750 patients will be randomized 1:1 to receive either a NOAC or LAAO using the Amplatzer Amulet (Abbott, MN, USA) or Watchman FLX (Boston Scientific, MN, USA) with subsequent life-long aspirin 75 mg daily. Follow-up will be based on in-office and telephone follow-up in combination with long-term follow-up (10 years) through national hospital discharge registries in the individual Nordic countries. The primary outcome will be a composite endpoint of stroke, systemic embolism, major bleeding (BARC ≥ 3) and all-cause mortality at 2-year follow-up. CONCLUSIONS: The Occlusion-AF trial is designed to compare LAAO to NOAC therapy for secondary stroke prevention in AF patients with a high risk of recurrent thromboembolic events, i.e. with previous ischemic stroke or TIA, and otherwise eligible for anticoagulation. The results are expected to contribute significantly to the understanding of the effects of LAAO compared to the standard contemporary pharmacological treatment in these patients.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Stroke , Administration, Oral , Anticoagulants/therapeutic use , Atrial Appendage/surgery , Atrial Fibrillation/complications , Atrial Fibrillation/drug therapy , Humans , Stroke/drug therapy , Stroke/etiology , Stroke/prevention & control , Treatment Outcome
13.
Int J Qual Health Care ; 34(2)2022 Apr 15.
Article in English | MEDLINE | ID: mdl-35323967

ABSTRACT

BACKGROUND: The aim of accreditation is to improve quality of care and patient safety. However, studies on the effectiveness of accreditation on clinical outcomes are limited and inconsistent. Comparative studies have contrasted accredited with non-accredited hospitals or hospitals without a benchmark, but assessments of clinical outcomes of patients treated at hospitals undergoing accreditation are sparse. The Faroe Islands hospitals were accredited for the first time in 2017, making them an ideal place to study the impact of accreditation. OBJECTIVE: We aimed to investigate the association between first-time hospital accreditation and length of stay (LOS), acute readmission (AR) and 30-day mortality in the unique situation of the Faroe Islands. METHODS: We conducted a before and after study based on medical record reviews in relation to first-time accreditation. All three Faroese hospitals were voluntarily accredited using a modified second version of the Danish Healthcare Quality Programme encompassing 76 standards. We included inpatients 18 years or older treated at a Faroese hospital with one of six clinical conditions (stroke/transient ischemic attack (TIA), bleeding gastic ulcer, chronic obstructive pulmonary disease (COPD), childbirth, heart failure and hip fracture) in 2012-2013 designated 'before accreditation'or 2017-2018' after accreditation'. The main outcome measures were LOS, all-cause AR and all-cause 30-day mortality. We computed adjusted cause-specific hazard rate (HR) ratios using Cox Proportional Hazard regression with before accreditation as reference. The analyses were controlled for age, sex, cohabitant status, in-hospital rehabilitation, type of admission, diagnosis and cluster effect at patient and hospital levels. RESULTS: The mean LOS was 13.4 days [95% confidence interval (95% CI): 10.8, 15.9] before accreditation and 7.5 days (95% CI: 6.10, 8.89) after accreditation. LOS of patients hospitalized after accreditation was significantly shorter [overall, adjusted HR = 1.23 (95% CI: 1.04, 1.46)]. By medical condition, only women in childbirth had a significantly shorter LOS [adjusted HR = 1.30 (95% CI: 1.04, 1.62)]. In total, 12.3% of inpatients before and 9.5% after accreditation were readmitted acutely within 30 days of discharge, and 30-day mortality was 3.3% among inpatients before and 2.8% after accreditation, respectively. No associations were found overall or by medical condition for AR [overall, adjusted HR = 1.34 (95% CI: 0.82, 2.18)] or 30-day mortality [overall, adjusted HR = 1.33 (95% CI: 0.55, 3.21)]) after adjustment for potential confounding factors. CONCLUSION: First-time hospital accreditation in the Faroe Islands was associated with a significant reduction in LOS, especially of women in childbirth. Notably, shorter LOS was not followed by increased AR. There was no evidence that first-time accreditation lowered the risk of AR or 30-day mortality.


Subject(s)
Accreditation , Heart Failure , Female , Hospitalization , Hospitals , Humans , Length of Stay , Patient Readmission
14.
BMC Health Serv Res ; 21(1): 917, 2021 Sep 05.
Article in English | MEDLINE | ID: mdl-34482842

ABSTRACT

BACKGROUND: Significant resources are spent on hospital accreditation worldwide. However, documentation of the effects of accreditation on processes, quality of care and outcomes in healthcare remain scarce. This study aimed to examine changes in the delivery of patient care in accordance with clinical guidelines (recommended care) after first-time accreditation in a care setting not previously exposed to systematic quality improvement initiatives. METHODS: We conducted a before and after study based on medical record reviews in connection with introducing first-time accreditation. We included patients with stroke/transient ischemic attack, bleeding gastric ulcer, diabetes, chronic obstructive pulmonary disease (COPD), childbirth, heart failure and hip fracture treated at public, non-psychiatric Faroese hospitals during 2012-2013 (before accreditation) or 2017-2018 (after accreditation). The intervention was the implementation of a modified second version of The Danish Healthcare Quality Program (DDKM) from 2014 to 2016 including an on-site accreditation survey in the Faroese hospitals. Recommended care was assessed using 63 disease specific patient level process performance measures in seven clinical conditions. We calculated the fulfillment and changes in the opportunity-based composite score and the all-or-none score. RESULTS: We included 867 patient pathways (536 before and 331 after). After accreditation, the total opportunity-based composite score was marginally higher though the change did not reach statistical significance (adjusted percentage point difference (%): 4.4%; 95% CI: - 0.7 to 9.6). At disease level, patients with stroke/transient ischemic attack, bleeding gastric ulcer, COPD and childbirth received a higher proportion of recommended care after accreditation. No difference was found for heart failure and diabetes. Hip fracture received less recommended care after accreditation. The total all-or-none score, which is the probability of a patient receiving all recommended care, was significantly higher after accreditation (adjusted relative risk (RR): 2.32; 95% CI: 2.03 to 2.67). The improvement was particularly strong for patients with COPD (RR: 16.22; 95% CI: 14.54 to 18.10). CONCLUSION: Hospitals were in general more likely to provide recommended care after first-time accreditation.


Subject(s)
Accreditation , Heart Failure , Denmark , Hospitals, Public , Humans , Quality Improvement
15.
Nord J Psychiatry ; 75(7): 547-552, 2021 Oct.
Article in English | MEDLINE | ID: mdl-33825660

ABSTRACT

BACKGROUND: Cardiovascular autonomic neuropathy (CAN) is an independent predictor of cardiovascular disease (CVD) in patients with diabetes as well as in patients with pre-diabetes and metabolic syndrome. Patients with schizophrenia have an increased rate of metabolic syndrome, pre-diabetes and diabetes as compared to the general population. Despite of this, occurrence CAN has not been investigated in patient with schizophrenia. Therefore, the aims of this study were (1) to evaluate the feasibility testing for CAN with a new clinical tool and (2) report the prevalence of early and manifest CAN in patients with schizophrenia. METHODS AND RESULTS: Patients with diagnosed schizophrenia and with a disease duration ≥10 years were matched 1:1 on age and gender at screening with psychiatric healthy controls. CAN was defined as ≥ two abnormal standard cardiovascular autonomic reflex tests (lying-to-standing, deep breathing, and Valsalva maneuver) using the VagusTM device. A total of 46 patients with schizophrenia were included and matched to psychiatric healthy controls. Manifest CAN were more frequently presented in patients with schizophrenia (39% vs. 6% for controls, p<.0001). Sensitivity analysis of 41 subjects with schizophrenia without diabetes matched to 41 psychiatric healthy controls, showed similar results (37% vs. 5% for controls, p<.0001). CONCLUSION: CAN is highly prevalent in patients with schizophrenia. Testing for CAN is feasible and might be a new clinically tool for detecting early stages of CVD in patients with schizophrenia.


Subject(s)
Autonomic Nervous System Diseases , Cardiovascular Diseases , Schizophrenia , Autonomic Nervous System , Autonomic Nervous System Diseases/diagnosis , Autonomic Nervous System Diseases/epidemiology , Autonomic Nervous System Diseases/etiology , Cardiovascular Diseases/epidemiology , Heart Rate , Humans , Schizophrenia/complications , Schizophrenia/epidemiology , Valsalva Maneuver
16.
Stroke ; 51(8): 2332-2338, 2020 08.
Article in English | MEDLINE | ID: mdl-32640943

ABSTRACT

BACKGROUND AND PURPOSE: Previous studies from local settings have reported that women with acute ischemic stroke have a lower chance of receiving reperfusion therapy treatment, including intravenous thrombolysis and thrombectomy, than men, but the underlying mechanisms of this disparity have not been identified. We aimed to examine sex differences in the utilization of reperfusion therapy focusing on all the phases of pre- and in-hospital time delay in a nationwide population-based cohort. METHODS: This study was based on data from nationwide public registries. The study population included patients aged at least 18 years admitted with acute ischemic stroke using emergency medical services in Denmark dispatched after an emergency call in the period 2016 to 2017. Study outcomes included time delays from symptom onset to start of reperfusion therapy and use of reperfusion therapy. Data were analyzed using multivariable quantile regression and logistic regression. RESULTS: A total of 5356 stroke events fulfilled the inclusion criteria. Women (26.6%) were less likely to receive intravenous thrombolysis than men (30.2 %), corresponding to an unadjusted odds ratio of 0.84 (95% CI, 0.74-0.95). In addition, women experienced a 20 minutes longer median time delay from stroke symptom onset to stroke unit arrival than men. Adjusting for onset-to-door time only appeared to have a limited effect on the sex differences in use of intravenous thrombolysis, whereas the odds ratio was 1.06 (95% CI, 0.93-1.21) when adjusting for age at stroke, stroke severity, and cohabitation status. No sex difference was observed for the use of thrombectomy. CONCLUSIONS: Women received less reperfusion therapy than men and had a longer time delay from symptom onset to stroke unit arrival, primarily due to a longer delay from symptom onset to emergency medical services call. These differences appeared to be due to the higher age and the higher proportion of women living alone at the time of the stroke.


Subject(s)
Brain Ischemia/therapy , Sex Characteristics , Stroke/therapy , Thrombolytic Therapy/methods , Aged , Aged, 80 and over , Brain Ischemia/diagnosis , Brain Ischemia/epidemiology , Denmark/epidemiology , Female , Humans , Male , Middle Aged , Registries , Stroke/diagnosis , Stroke/epidemiology
17.
Eur Eat Disord Rev ; 24(5): 366-76, 2016 09.
Article in English | MEDLINE | ID: mdl-27062554

ABSTRACT

OBJECTIVE: The aim of this study was to characterise the association between the cognitive profile and weight restoration in children and adolescents with anorexia nervosa. METHODS: The study was a longitudinal, matched case-control, multicentre study. An assessment of cognitive functions was conducted by using the Wechsler Intelligence Scale for Children-III/the Wechsler Adult Intelligence Scale-III, the Test of Memory and Learning-second edition, Trail Making Tests A and B, the Rey-Osterrieth Complex Figure Test and the Cambridge Neuropsychological Test Automated Battery. RESULTS: One hundred twenty individuals, 60 patients with anorexia nervosa with mean age of 14.65 (SD 1.820) years and 60 healthy controls with mean age of 14.76 (SD 1.704) years, participated. No association was found between weight recovery and cognitive functions. However, a significant increase in motor speed was found in Trail Making Test A (p = 0.004), Reaction Time (RTI) five-choice movement time (p = 0.002) and RTI simple movement time (p = 0.011), resulting in a normalisation corresponding to that found in healthy controls. Furthermore, a significantly lower score in the perceptual organization index (p = 0.029) was found at follow-up. CONCLUSIONS: Weight recovery appears not to be associated with cognition. Copyright © 2016 The Authors European Eating Disorders Review published by Eating Disorders Association and John Wiley & Sons Ltd.


Subject(s)
Anorexia Nervosa/psychology , Cognition Disorders/diagnosis , Cognition , Neuropsychological Tests/statistics & numerical data , Adolescent , Adult , Anorexia Nervosa/diagnosis , Body Weight , Child , Cognition Disorders/psychology , Female , Hospitalization , Humans , Intelligence , Intelligence Tests , Male , Memory , Trail Making Test , Wechsler Scales
18.
BMJ Open Qual ; 13(1)2024 02 12.
Article in English | MEDLINE | ID: mdl-38350672

ABSTRACT

BACKGROUND: Patient-reported outcome measures (PROMs) are valuable and necessary tools for establishing and maintaining patient-centred healthcare. The PRO-Psychiatry initiative was primarily initiated to support the patient's voice in treatment decision-making and secondarily to monitor patient-perceived quality of care. The result of the initiative is a patient-reported instrument developed in collaboration between patients and clinicians. We aimed to validate the PROM developed for measuring self-perceived health among psychiatric patients in North Denmark Region, in terms of internal consistency, criterion validity and responsiveness. METHOD: Patients in contact with a psychiatric hospital in the North Denmark Region from September 2018 to March 2021 were included in the study. The PROM constitutes a scale of 17 items covering various aspects of self-perceived health including well-being (7 items), lack of well-being (5 items) and social functioning (5 items), where the former domain entails the WHO-5 Well-Being Index. The potential range of the total scale score is 0-85. We applied McDonald's omega, average inter-item correlation (AIIC) and differential item functioning (DIF). In addition, we used mixed effects analyses to estimate temporal correlations. The instrument was compared with self-rated overall mental and psychiatric health. RESULTS: The patient population consisted of 1132 unique patients and a total of 2476 responses corresponding to one response per patient pathway. McDonald's omega was found to be 0.92 (95% CI 0.92 to 0.93), while the AIIC was found to be 0.42 (95% CI 0.39 to 0.44). For DIF, the largest systematic variation resulted in a maximum difference of 2.3 points on the total score when adjusting for the latent trait and was found when comparing initial measurements with follow-up measurements. The correlation between the total score and the outcomes regarding overall physical and mental health was 0.52 (95% CI 0.48 to 0.56) and 0.74 (95% CI 0.72 to 0.76). Similar correlations were found for the corresponding changes over time. CONCLUSION: The scale showed high consistency and little systematic variation between the comparison groups. The concurrent correlations and analyses of responsiveness coincided with the prespecified hypotheses. Overall, we deem the Danish PRO-Psychiatry instrument to possess suitable psychometric properties for measuring self-perceived health among a psychiatric population.


Subject(s)
Mental Health , Patient Reported Outcome Measures , Humans , Surveys and Questionnaires , Health Status , Denmark
19.
Intern Emerg Med ; 19(2): 445-453, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38123903

ABSTRACT

Accurate estimation of ambulance transport time from the scene of incident to arrival at the emergency department (ED) is important for effective resource management and emergency care system planning. Further, differences in transport times between different urgency levels highlight the benefits of ambulance transports with highest urgency level in a setting where ambulances are allowed to not follow standard traffic rules. The objective of the study is to compare ambulance urgency level on the differences in estimates of ambulance transport times generated by Google Maps and the observed transport times in a prehospital setting where emergency vehicles have their own traffic laws. The study was designed as a natural experiment and register study. Ambulance transports dispatched with different levels of urgency (Level A and B) were included in the Central Denmark Region (a mixed urban and rural area) from March 10 to June 11, 2021. Ambulance transports for highest urgency level were compared to lowest urgency level with Google Maps estimated transport times as reference. We analyzed 1981 highest urgency level and 8.958 lowest urgency level ambulance transports. Google Maps significantly overestimated the duration of transports operating at highest level of urgency (Level A) by 1.9 min/10 km (95% CI 1.8; 2.0) in average and 4.8 min/10 km (95% CI 3.9; 5.6) for the first driven 10 km. Contrary, Google Maps significantly underestimated the duration of transports operating at lowest level of urgency (Level B) by -1.8 min/10 km (95% CI -2.1; -1.5) in average and -4.4 min/10 km (95% CI -5.4; -3.5) for the first driven 10 km. Google Maps systematically overestimates transport times of ambulance transports driven with Level A, the highest level of urgency in a setting where ambulances are allowed to not follow standard traffic rules. The results highlight the benefit of using urgency Level A and provide valuable information for emergency care management.


Subject(s)
Emergency Medical Services , Humans , Ambulances , Emergency Service, Hospital
20.
Eur J Trauma Emerg Surg ; 50(3): 975-985, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38353716

ABSTRACT

PURPOSE: To compare patients with and without a history of mental illness on process and outcome measures in relation to prehospital and emergency surgical care for patients with perforated ulcer. METHODS: A nationwide registry-based cohort study of patients undergoing emergency surgery for perforated ulcer. We used data from the Danish Prehospital Database 2016-2017 and the Danish Emergency Surgery Registry 2004-2018 combined with data from other Danish databases. Patients were categorized according to severity of mental health history. RESULTS: We identified 4.767 patients undergoing emergency surgery for perforated ulcer. Among patients calling the EMS with no history of mental illness, 51% were identified with abdominal pain when calling the EMS compared to 31% and 25% among patients with a history of moderate and major mental illness, respectively. Median time from hospital arrival to surgery was 6.0 h (IQR: 3.6;10.7). Adjusting for age, sex and comorbidity, patients with a history of major mental illness underwent surgery 46 min (95% CI: 4;88) later compared to patients with no history of mental illness. Median number of days-alive-and-out-of-hospital at 90-day follow-up was 67 days (IQR: 0;83). Adjusting for age, sex and comorbidity, patients with a history of major mental illness had 9 days (95% CI: 4;14) less alive and out-of-hospital at 90-day follow-up. CONCLUSION: One-third of the population had a history of mental illness or vulnerability. Patients with a history of major mental illness were less likely to be identified with abdominal pain if calling the EMS prior to arrival. They had longer delays from hospital arrival to surgery and higher mortality.


Subject(s)
Mental Disorders , Peptic Ulcer Perforation , Registries , Humans , Male , Female , Denmark/epidemiology , Middle Aged , Aged , Peptic Ulcer Perforation/surgery , Peptic Ulcer Perforation/mortality , Emergency Medical Services , Healthcare Disparities/statistics & numerical data , Adult , Time-to-Treatment/statistics & numerical data , Cohort Studies
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