Association between heavy alcohol consumption and cryptogenic ischaemic stroke in young adults: a case-control study.

BACKGROUND: The underlying risk factors for young-onset cryptogenic ischaemic stroke (CIS) remain unclear. This multicentre study aimed to explore the association between heavy alcohol consumption and CIS with subgroup analyses stratified by sex and age. METHODS: Altogether, 540 patients aged 18-49 years (median age 41; 47.2% women) with a recent CIS and 540 sex-matched and age-matched stroke-free controls were included. Heavy alcohol consumption was defined as >7 (women) and >14 (men) units per week or at least an average of two times per month ≥5 (women) and ≥7 (men) units per instance (binge drinking). A conditional logistic regression adjusting for age, sex, education, hypertension, cardiovascular diseases, diabetes, hypercholesterolaemia, current smoking, obesity, diet and physical inactivity was used to assess the independent association between alcohol consumption and CIS. RESULTS: Patients were twice as more often heavy alcohol users compared with controls (13.7% vs 6.7%, p<0.001), were more likely to have hypertension and they were more often current smokers, overweight and physically inactive. In the entire study population, heavy alcohol consumption was independently associated with CIS (adjusted OR 2.11; 95% CI 1.22 to 3.63). In sex-specific analysis, heavy alcohol consumption was associated with CIS in men (2.72; 95% CI 1.25 to 5.92), but not in women (1.56; 95% CI 0.71 to 3.41). When exploring the association with binge drinking alone, a significant association was shown in the entire cohort (2.43; 95% CI 1.31 to 4.53) and in men (3.36; 95% CI 1.44 to 7.84), but not in women. CONCLUSIONS: Heavy alcohol consumption, particularly binge drinking, appears to be an independent risk factor in young men with CIS.

A metabolic profile of xenon and metabolite associations with 6-month mortality after out-of-hospital cardiac arrest: A post-hoc study of the randomised Xe-Hypotheca trial.

PURPOSE: Out-of-hospital cardiac arrest (OHCA) carries a relatively poor prognosis and requires multimodal prognostication to guide clinical decisions. Identification of previously unrecognized metabolic routes associated with patient outcome may contribute to future biomarker discovery. In OHCA, inhaled xenon elicits neuro- and cardioprotection. However, the metabolic effects remain unknown. MATERIALS AND METHODS: In this post-hoc study of the randomised, 2-group, single-blind, phase 2 Xe-Hypotheca trial, 110 OHCA survivors were randomised 1:1 to receive targeted temperature management (TTM) at 33°C with or without inhaled xenon during 24 h. Blood samples for nuclear magnetic resonance spectroscopy metabolic profiling were drawn upon admission, at 24 and 72 h. RESULTS: At 24 h, increased lactate, adjusted hazard-ratio 2.25, 95% CI [1.53; 3.30], p<0.001, and decreased branched-chain amino acids (BCAA) leucine 0.64 [0.5; 0.82], p = 0.007, and valine 0.37 [0.22; 0.63], p = 0.003, associated with 6-month mortality. At 72 h, increased lactate 2.77 [1.76; 4.36], p<0.001, and alanine 2.43 [1.56; 3.78], p = 0.001, and decreased small HDL cholesterol ester content (S-HDL-CE) 0.36 [0.19; 0.68], p = 0.021, associated with mortality. No difference was observed between xenon and control groups. CONCLUSIONS: In OHCA patients receiving TTM with or without xenon, high lactate and alanine and decreased BCAAs and S-HDL-CE associated with increased mortality. It remains to be established whether current observations on BCAAs, and possibly alanine and lactate, could reflect neural damage via their roles in the metabolism of the neurotransmitter glutamate. Xenon did not significantly alter the measured metabolic profile, a potentially beneficial attribute in the context of compromised ICU patients. TRIAL REGISTRATION: Trial Registry number: ClinicalTrials.gov Identifier: NCT00879892.

Andexanet for Factor Xa Inhibitor-Associated Acute Intracerebral Hemorrhage.

BACKGROUND: Patients with acute intracerebral hemorrhage who are receiving factor Xa inhibitors have a risk of hematoma expansion. The effect of andexanet alfa, an agent that reverses the effects of factor Xa inhibitors, on hematoma volume expansion has not been well studied. METHODS: We randomly assigned, in a 1:1 ratio, patients who had taken factor Xa inhibitors within 15 hours before having an acute intracerebral hemorrhage to receive andexanet or usual care. The primary end point was hemostatic efficacy, defined by expansion of the hematoma volume by 35% or less at 12 hours after baseline, an increase in the score on the National Institutes of Health Stroke Scale of less than 7 points (scores range from 0 to 42, with higher scores indicating worse neurologic deficit) at 12 hours, and no receipt of rescue therapy between 3 hours and 12 hours. Safety end points were thrombotic events and death. RESULTS: A total of 263 patients were assigned to receive andexanet, and 267 to receive usual care. Efficacy was assessed in an interim analysis that included 452 patients, and safety was analyzed in all 530 enrolled patients. Atrial fibrillation was the most common indication for factor Xa inhibitors. Of the patients receiving usual care, 85.5% received prothrombin complex concentrate. Hemostatic efficacy was achieved in 150 of 224 patients (67.0%) receiving andexanet and in 121 of 228 (53.1%) receiving usual care (adjusted difference, 13.4 percentage points; 95% confidence interval [CI], 4.6 to 22.2; P = 0.003). The median reduction from baseline to the 1-to-2-hour nadir in anti-factor Xa activity was 94.5% with andexanet and 26.9% with usual care (P<0.001). Thrombotic events occurred in 27 of 263 patients (10.3%) receiving andexanet and in 15 of 267 (5.6%) receiving usual care (difference, 4.6 percentage points; 95% CI, 0.1 to 9.2; P = 0.048); ischemic stroke occurred in 17 patients (6.5%) and 4 patients (1.5%), respectively. There were no appreciable differences between the groups in the score on the modified Rankin scale or in death within 30 days. CONCLUSIONS: Among patients with intracerebral hemorrhage who were receiving factor Xa inhibitors, andexanet resulted in better control of hematoma expansion than usual care but was associated with thrombotic events, including ischemic stroke. (Funded by Alexion AstraZeneca Rare Disease and others; ANNEXA-I ClinicalTrials.gov number, NCT03661528.).

Agreement between physician- and patient-reported Canadian cardiovascular society scores among patients undergoing elective coronary angiography-The CATS study.

The primary aim of revascularization in stable coronary artery disease (CAD) is symptom relief. The severity of symptoms is usually evaluated by the physician, not by the patient. We examined the agreement between physician- and patient-reported Canadian Cardiovascular Society (CCS) scores among patients scheduled for elective coronary angiography in a cross-sectional study. Patients (n = 650) and cardiologists evaluated the severity of angina symptoms by filling the CCS questionnaire before coronary angiography. Patients were divided into those without CAD (stenosis diameter <50%, n = 445) and those with CAD (stenosis diameter >50%, n = 205). CAD patients were further divided into three groups according to disease severity (single-, double- or triple-vessel disease). The mean age of the patients was 67.6 (9.9) years and 50.6% were women. In 51.8% (95% CI 44.5%-59.0%) of patients with CAD and 51.9% (95% CI 47.0%-56.8%) of those without, physician- and patient reported CCS scores agreed. The physician reported better CCS scores in 33.9% (95% CI 27.6%-40.7%) of patients with CAD and 36.2% (95% CI 31.8%-41.0%) of patients without CAD. The proportions of full or partial agreement between physician- and patient reported CCS scores were similar across the CAD severity groups. To summarize, we observed a significant discrepancy between the physician- and patient-reported symptom severity in patients with or without CAD scheduled for angiography. The physician underestimated the symptoms in third of the cases. Thus, patient-reported symptom severity, rather than physician's evaluation, should be the cornerstone of treatment decisions.

Health care costs and changes in subjective health-related quality of life among Finnish adolescents referred to secondary psychiatric out-patient services: a one-year follow-up study.

Background: There has been growing interest in economic evidence regarding treatment of mental disorders. Objective: The purpose of this one-year follow-up study was to evaluate the secondary health care costs and changes in health-related quality of life (HRQoL) in three common adolescent psychiatric disorder groups. Further, HRQoL of patients was compared to that of population controls. Methods: Twelve- to fourteen-year-old adolescents with behavioral and emotional disorders (n = 37), mood disorders (n = 35), and anxiety disorders (n = 34), completed the 16D HRQoL questionnaire when they entered the adolescent psychiatric outpatient clinics (baseline) and at follow-up. The direct secondary health care costs were calculated using a clinical patient administration system. Population controls included 373 same-aged pupils from randomly selected 13 comprehensive schools. Results: The direct secondary health care costs did not differ significantly between the three patient groups. However, in adolescents with mood disorders, this investment generated a significant and clinically important improvement in HRQoL, which was not observed in the other two patient groups. Conclusions: The costs of health care alone do not necessarily reflect its quality.

Digital solution in the follow-up of early breast cancer a randomized study.

BACKGROUND: After primary treatment, patients with early breast cancer (EBC) are followed-up for at least 5 years. At the Helsinki University Hospital (HUS) surveillance includes appointments at 1, 3 and 5 years, and between pre-planned visits a phone call service operated by a nurse practitioner for counseling about symptoms related to side-effects or potential recurrence. In 2015 HUS launched a digital solution for cancer patients. This study was designed to find out patient preference, Health related (HR) quality of life (QOL) and satisfaction with a digital solution compared to a phone call service during the first year of follow-up. MATERIAL AND METHODS: Patients with EBC were randomized at the final visit of radiotherapy to surveillance by phone calls or by the digital Noona solution during the first year outside pre-planned visits. After six months the groups were crossed over to the other arm. Primary endpoint was patient preference for either follow-up method among those who had contacted the study nurse at least once by both phone service and digital solution. RESULTS: Out of the 765 patients randomized, 142 had contacted the hospital with both methods and were eligible for inclusion in the analyses of the present study. Out of the 142 patients, 56 preferred phone calls, 43 the digital solution while 43 considered both modalities equal. Preference for the digital solution was higher among patients aged 65 or less. There were no differences in HR QoL or overall satisfaction between the modalities. However, the patients rated the timeliness of response better while using the digital solution. CONCLUSION: Of the patients 30% preferred the digital solution, 40% phone calls while 30% found them equal as the primary follow-up method for EBC during the first year outside pre-planned visits. There is a need to include also digital solutions in surveillance of EBC. CLINICALTRIALS.GOV IDENTIFIER: NCT04980989.

24-hour ambulatory blood pressure and cryptogenic ischemic stroke in young adults.

BACKGROUND: In young patients, up to 40% of ischemic strokes remain cryptogenic despite modern-day diagnostic work-up. There are limited data on blood pressure (BP) behavior in these patients. Thus, we aimed to compare ambulatory blood pressure (ABP) profiles between young patients with a recent cryptogenic ischemic stroke (CIS) and stroke-free controls. PATIENTS AND METHODS: In this substudy of the international multicenter case-control study SECRETO (NCT01934725), 24-hour ambulatory blood pressure monitoring (ABPM) was performed in consecutive 18-49-year-old CIS patients and stroke-free controls. The inclusion criteria were met by 132 patients (median age, 41.9 years; 56.1% males) and 106 controls (41.9 years; 56.6% males). We assessed not only 24-hour, daytime, and nighttime ABP but also hypertension phenotypes and nocturnal dipping status. RESULTS: 24-hour and daytime ABP were higher among controls. After adjusting for relevant confounders, a non-dipping pattern of diastolic blood pressure (DBP) was associated with CIS in the entire sample (odds ratio, 3.85; 95% confidence interval, 1.20-12.42), in participants without antihypertensives (4.86; 1.07-22.02), and in participants without a patent foramen ovale (PFO) (7.37; 1.47-36.81). After excluding patients in the first tertile of the delay between the stroke and ABPM, a non-dipping pattern of DBP was not associated with CIS, but a non-dipping pattern of both systolic BP and DBP was (4.85; 1.37-17.10). In participants with a PFO and in those without hypertension by any definition, no associations between non-dipping patterns of BP and CIS emerged. CONCLUSIONS: Non-dipping patterns of BP were associated with CIS in the absence of a PFO but not in the absence of hypertension. This may reflect differing pathophysiology underlying CIS in patients with versus without a PFO. Due to limitations of the study, results regarding absolute ABP levels should be interpreted with caution.Key MessagesNocturnal non-dipping patterns of blood pressure were associated with cryptogenic ischemic stroke except in participants with a patent foramen ovale and in those without hypertension by any definition, which may indicate differing pathophysiology underlying cryptogenic ischemic stroke in patients with and without a patent foramen ovale.It might be reasonable to include ambulatory blood pressure monitoring in the diagnostic work-up for young patients with ischemic stroke to detect not only the absolute ambulatory blood pressure levels but also their blood pressure behavior.

Health-related quality of life and anxiety levels among patients under surveillance for intraductal papillary mucinous neoplasm.

BACKGROUND: Because of the premalignant nature of intraductal papillary mucinous neoplasms (IPMNs), patients should undergo surveillance as long as they remain fit for surgery. This surveillance, with imaging and laboratory tests every 6 to 12 months, is expensive and may psychologically burden patients. This study aimed to determine the effects of IPMN surveillance on patients´ health-related quality of life (HRQoL) and anxiety levels. METHODS: We included a random subgroup of all IPMN patients undergoing a follow-up check-up at Helsinki University Hospital (HUH) between August 2017 and November 2018. Patients were asked to complete the 15D HRQoL and state-trait anxiety inventory (STAI) questionnaires just before and three months after an IPMN control. RESULTS: Among 899 patients in IPMN follow-up, 232 participated. The 15D HRQoL results showed differences in some IPMN patients' 15 analyzed dimensions compared to a sex- and age-standardized general population cohort, but the clinical relevance of these differences appear doubtful. We detected no significant difference in the anxiety levels determined using the STAI questionnaires before or three months after the IPMN control. CONCLUSION: Surveillance should be less harmful than the risk of disease. Among our patients, the recommended IPMN follow-up carried minimal negative impact on patients' HRQoL or anxiety levels. This result is important, because the number of patients under IPMN surveillance is rapidly increasing and the cancer risk among the majority of these patients remains small. TRIAL REGISTRATION: The Surgical Ethics Committee of Helsinki University Hospital approved this study (Dnro HUS 475/2017) and it was registered at ClinicalTrials.gov (NCT03131076) before patient enrollment began.

Comparison of the prognostic value of early-phase proton magnetic resonance spectroscopy and diffusion tensor imaging with serum neuron-specific enolase at 72 h in comatose survivors of out-of-hospital cardiac arrest-a substudy of the XeHypotheca trial.

PURPOSE: We compared the predictive accuracy of early-phase brain diffusion tensor imaging (DTI), proton magnetic resonance spectroscopy (1H-MRS), and serum neuron-specific enolase (NSE) against the motor score and epileptic seizures (ES) for poor neurological outcome after out-of-hospital cardiac arrest (OHCA). METHODS: The predictive accuracy of DTI, 1H-MRS, and NSE along with motor score at 72 h and ES for the poor neurological outcome (modified Rankin Scale, mRS, 3 - 6) in 92 comatose OHCA patients at 6 months was assessed by area under the receiver operating characteristic curve (AUROC). Combined models of the variables were included as exploratory. RESULTS: The predictive accuracy of fractional anisotropy (FA) of DTI (AUROC 0.73, 95% CI 0.62-0.84), total N-acetyl aspartate/total creatine (tNAA/tCr) of 1H-MRS (0.78 (0.68 - 0.88)), or NSE at 72 h (0.85 (0.76 - 0.93)) was not significantly better than motor score at 72 h (0.88 (95% CI 0.80-0.96)). The addition of FA and tNAA/tCr to a combination of NSE, motor score, and ES provided a small but statistically significant improvement in predictive accuracy (AUROC 0.92 (0.85-0.98) vs 0.98 (0.96-1.00), p = 0.037). CONCLUSION: None of the variables (FA, tNAA/tCr, ES, NSE at 72 h, and motor score at 72 h) differed significantly in predicting poor outcomes in this patient group. Early-phase quantitative neuroimaging provided a statistically significant improvement for the predictive value when combined with ES and motor score with or without NSE. However, in clinical practice, the additional value is small, and considering the costs and challenges of imaging in this patient group, early-phase DTI/MRS cannot be recommended for routine use. TRIAL REGISTRATION: ClinicalTrials.gov NCT00879892, April 13, 2009.

Surgery, Limb Edema and Health-related Quality of Life: A Prospective Follow-up Study on Patients With Cutaneous Malignant Melanoma.

BACKGROUND/AIM: The latest developments in oncological therapies for malignant melanoma, and the discovery that complete lymph node dissection offers no survival benefit, are changing the landscape of melanoma surgery. There is a need for more information on health-related quality of life (HRQoL) consequences of melanoma surgery. PATIENTS AND METHODS: This longitudinal cohort study was carried out from 2004 to 2009 in the Helsinki and Uusimaa Hospital District and patients were followed-up at 6, 12 and 24 months. The patients were asked to fill in the generic 15D questionnaire and the cancer-specific European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). In addition, they were asked selected questions from the EORTC Item Library regarding upper and lower limb edema. RESULTS: A total of 169 (64.5%) patients with local or locally advanced melanoma referred for surgical treatment responded, of whom 161 were included in the final analysis. For the whole patient group, distress, depression and emotional function improved over time. Worse HRQoL in some of the dimensions were associated with female sex, skin transplant versus direct wound closure and complications 30 days or more after surgery, but none was associated with worse overall HRQoL. Postoperative complications, type of wound closure or lymph node surgery had no effect on overall HRQoL. Patient-reported limb edema was associated with worse overall HRQoL at baseline and during follow-up by both instruments. Patients reporting limb edema reported worse mobility and more pain throughout the study. CONCLUSION: Patient-reported limb edema, regardless of the cause, seems to be an important predictor of worse HRQoL among patients with melanoma.

Factor XIa inhibition with asundexian after acute non-cardioembolic ischaemic stroke (PACIFIC-Stroke): an international, randomised, double-blind, placebo-controlled, phase 2b trial.

BACKGROUND: Asundexian (Bayer AG, Leverkusen, Germany), an oral small molecule factor XIa (FXIa) inhibitor, might prevent thrombosis without increasing bleeding. Asundexian's effect for secondary prevention of recurrent stroke is unknown. METHODS: In this randomised, double-blind, placebo-controlled, phase 2b dose-finding trial (PACIFIC-Stroke), patients with acute (within 48 h) non-cardioembolic ischaemic stroke were recruited from 196 hospitals in 23 countries. Patients were eligible if they were aged 45 years or older, to be treated with antiplatelet therapy, and able to have a baseline MRI (either before or within 72 h of randomisation). Eligible participants were randomly assigned (1:1:1:1), using an interactive web-based response system and stratified according to anticipated antiplatelet therapy (single vs dual), to once daily oral asundexian (BAY 2433334) 10 mg, 20 mg, or 50 mg, or placebo in addition to usual antiplatelet therapy, and were followed up during treatment for 26-52 weeks. Brain MRIs were obtained at study entry and at 26 weeks or as soon as possible after treatment discontinuation. The primary efficacy outcome was the dose-response effect on the composite of incident MRI-detected covert brain infarcts and recurrent symptomatic ischaemic stroke at or before 26 weeks after randomisation. The primary safety outcome was major or clinically relevant non-major bleeding as defined by International Society on Thrombosis and Haemostasis criteria. The efficacy outcome was assessed in all participants assigned to treatment, and the safety outcome was assessed in all participants who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov, NCT04304508, and is now complete. FINDINGS: Between June 15, 2020, and July 22, 2021, 1880 patients were screened and 1808 participants were randomly assigned to asundexian 10 mg (n=455), 20 mg (n=450), or 50 mg (n=447), or placebo (n=456). Mean age was 67 years (SD 10) and 615 (34%) participants were women, 1193 (66%) were men, 1505 (83%) were White, and 268 (15%) were Asian. The mean time from index stroke to randomisation was 36 h (SD 10) and median baseline National Institutes of Health Stroke Scale score was 2·0 (IQR 1·0-4·0). 783 (43%) participants received dual antiplatelet treatment for a mean duration of 70·1 days (SD 113·4) after randomisation. At 26 weeks, the primary efficacy outcome was observed in 87 (19%) of 456 participants in the placebo group versus 86 (19%) of 455 in the asundexian 10 mg group (crude incidence ratio 0·99 [90% CI 0·79-1·24]), 99 (22%) of 450 in the asundexian 20 mg group (1·15 [0·93-1·43]), and 90 (20%) of 447 in the asundexian 50 mg group (1·06 [0·85-1·32]; t statistic -0·68; p=0·80). The primary safety outcome was observed in 11 (2%) of 452 participants in the placebo group versus 19 (4%) of 445 in the asundexian 10 mg group, 14 (3%) of 446 in the asundexian 20 mg group, and 19 (4%) of 443 in the asundexian 50 mg group (all asundexian doses pooled vs placebo hazard ratio 1·57 [90% CI 0·91-2·71]). INTERPRETATION: In this phase 2b trial, FXIa inhibition with asundexian did not reduce the composite of covert brain infarction or ischaemic stroke and did not increase the composite of major or clinically relevant non-major bleeding compared with placebo in patients with acute, non-cardioembolic ischaemic stroke. FUNDING: Bayer AG.

The Cost of Breast Cancer Surgery - Is the Money Spent Reflected on Health-related Quality of Life?

BACKGROUND/AIM: Different treatment options of breast cancer (BC) are dependent on certain cancer- and patient-related features. The cost of treatment varies among patients. This study describes the cost distribution in the treatment of Finnish patients with BC for two years and relates the costs to important outcomes of modern BC treatment. PATIENTS AND METHODS: Health-related quality of life (HRQoL) of 1,065 patients was measured prospectively at baseline, and 3, 6, 12, and 24 months thereafter with a generic (15D) and a disease-specific (EORTC QLQ C-30 BR23) HRQoL-instrument. Clinical data and costs of care were collected from hospital records. Patients were divided into four groups according to the surgical approach: breast-conserving surgery (BCS n=661), mastectomy (n=319), immediate reconstruction (IBR n=51), and delayed reconstruction (DR n=34), and the costs according to the clinic responsible for treatment: oncological-, breast surgery-, and plastic surgery unit. Total costs of care during follow-up are presented groupwise alongside HRQoL results. RESULTS: The mean total cost for BC surgery was 6,015 Euros for BCS, 8,114 euros for mastectomy, 18,217 Euros for IBR, and 19,041 Euros for DR. BCS, IBR, and DR produced good HRQoL. Mastectomy patients had the lowest overall HRQoL and highest cost accumulation at the oncology unit. HRQoL of IBR and DR patients was similar. CONCLUSION: DR produces good HRQoL but generates the highest costs of care. If patients that require reconstruction could be identified earlier and offered IBR instead of mastectomy followed by later DR, the costs of care might be reduced.

Long-term health-related quality of life in patients with ruptured arteriovenous malformations treated in childhood.

OBJECTIVE: The aim of this study was to reveal the long-term health-related quality of life (HRQOL), educational level, and impact on occupation in 55 patients who experienced ruptured brain arteriovenous malformations (AVMs) that were treated during childhood. METHODS: In 2016, questionnaires including the 15D instrument were sent to all living patients older than 18 years (n = 432) in the Helsinki AVM database. The cohort was further specified to include only patients with ruptured AVMs who were younger than 20 years at the time of diagnosis (n = 55). Educational level was compared with the age-matched general population of Finland. The mean 15D scores were calculated for independent variables (Spetzler-Ponce classification, admission age, symptomatic epilepsy, and multiple bleeding episodes) and tested using the independent-samples t-test or ANCOVA. Linear regression was used to create a multivariate model. Bonferroni correction was used with multiple comparisons. RESULTS: The mean follow-up time from diagnosis to survey was 24.2 (SD 14.7) years. The difference in the mean 15D scores between Spetzler-Ponce classes did not reach statistical significance. The youngest age group (< 10 years at the time of diagnosis) performed less well on the dimension of usual activities than the older patients. Symptomatic epilepsy significantly reduced the long-term HRQOL. Multiple hemorrhages significantly reduced the scores on three dimensions: mobility, speech, and sexual activity. In the regression model, symptomatic epilepsy was the only significant predictor for a lower 15D score. The educational level of the cohort was for the most part comparable to that of the general population in the same age group. AVM was the reason for early retirement in 11% of the patients, while lowered performance because of the AVM was reported by 37% of the patients. CONCLUSIONS: Patients with ruptured AVMs treated in childhood can live an independent and meaningful life, even in the case of the highest-grade lesions. Symptomatic epilepsy significantly reduced the long-term HRQOL, highlighting the need for continuing support for these patients.

Correlation of the disease-specific Canadian Cardiovascular Society (CCS) classification and health-related quality of life (15D) in coronary artery disease patients.

BACKGROUND: Generic health-related quality of life (HRQoL) and disease-specific instruments measure HRQoL from different aspects, although generic instruments often contain dimensions that reflect common symptoms. We evaluated how the change in 15D HRQoL and Canadian Cardiovascular Society (CCS) grading of angina severity correlate among coronary artery disease patients during 12-month follow-up. METHODS: Altogether 1 271 patients scheduled for coronary angiography between June 2015 and February 2017 returned the 15D HRQoL and CCS questionnaires before angiography and after one-year follow-up as a part of routine clinical practice. Spearman correlations between one-year changes in the CCS and the 15D and its dimensions were evaluated. Changes in 15D were classified into 5 categories based on the reported minimal important difference (MID) for the instrument. RESULTS: Change in the CCS grade correlated moderately with the MID-based change in the 15D (r = 0.33, 95% confidence interval 0.27-0.39). Correlations between these instruments were similar in different age groups, between sexes and treatment modalities. Of the individual 15D dimensions, changes in breathing (r = 0.40) and vitality (r = 0.30) had the strongest correlations with CCS change. CONCLUSION: The symptom-based evaluation of the change in the CCS grade may not catch the full benefit or harm of the treatment and vice versa, a generic instrument, such as 15D, likely does not fully capture change in disease-specific symptoms. Thus, generic and disease-specific instruments are complementary and should be used in conjunction.

Worse health-related quality of life, impaired functioning and psychiatric comorbidities are associated with excess mortality in patients with severe chronic pain.

BACKGROUND: Severe chronic pain that interferes with daily activities is associated with an increased risk of mortality. We assessed the overall mortality of tertiary chronic pain patients in comparison with the general population, with a special aim to analyse the association of health-related quality of life (HRQoL) and its dimensions with the risk of death. METHODS: In this prospective observational follow-up study, patients with non-cancer chronic pain attended an outpatient multidisciplinary pain management (MPM) episode in a tertiary pain clinic in 2004-2012 and were followed until May 2019. Mortality between the patients and the general population was compared with standardized mortality ratios (SMR) in different age groups. Causes of death and comorbidities were compared among the deceased. Association of mortality and HRQoL and its dimensions, measured with the 15D instrument, was studied with Cox proportional hazards model. RESULTS: During a mean of 10.4-year follow-up of 1498 patients, 296 died. The SMR in the youngest age group (18-49 years) was significantly higher than that of the general population: 2.6 for males and 2.9 for females. Even elderly females (60-69 years) had elevated mortality (SMR 2.3). Low baseline HRQoL at the time of MPM, as well as poor ratings in the psychosocial dimensions of HRQoL, was associated with an increased risk of death. CONCLUSIONS: Our results support the role of HRQoL measurement by a validated instrument such as the 15D in capturing both the physical and the psychological symptom burden, and consequently, an elevated risk of death, in patients with chronic pain. SIGNIFICANCE: Severe chronic pain is associated with elevated mortality. In patients in chronic pain under 50 years old, the mortality was 2.5-3 times higher than in the general population. Psychological distress appears to contribute to the increased mortality. Regular follow-up by health-related quality of life (HRQoL) measurement could be useful in identifying patients in chronic pain who are in need of intensive symptom management and to prevent early death.

Differential Cognitive Functioning and Benefit From Surgery in Patients Undergoing Coronary Artery Bypass Grafting and Carotid Endarterectomy.

Background: Stenosing atherosclerosis in both coronary and carotid arteries can adversely affect cognition. Also their surgical treatments, coronary artery bypass grafting (CABG) and carotid endarterectomy (CEA), are associated with cognitive changes, but the mechanisms of cognitive decline or improvement may not be the same. This study was designed to compare the cognitive profile and outcome in patients undergoing surgical treatment for coronary or carotid disease. Methods: A total of 100 CABG patients and 44 CEA patients were recruited in two previously reported studies. They were subjected to a comprehensive neuropsychological examination prior to surgery and in the acute (3-8 days) and stable (3 months) phase after operation. A group of 17 matched healthy controls were assessed with similar intervals. We used linear mixed models to compare cognitive trajectories within six functional domains between the CABG, CEA and control groups. Postoperative cognitive dysfunction (POCD) and improvement (POCI) were determined with the reliable change index method in comparison with healthy controls. Results: Before surgery, the CEA patients performed worse than CABG patients or healthy controls in the domains of executive functioning and processing speed. The CABG patients exhibited postoperative cognitive dysfunction more often than the CEA patients in most cognitive domains in the acute phase but had regained their performance in the stable phase. The CEA patients showed more marked postoperative improvement in executive functioning than the CABG group in the acute phase, but the difference did not reach significance in the stable phase. Conclusion: Our findings suggest that anterior cerebral dysfunction in CEA patients impairs preoperative cognition more severely than global brain dysfunction in CABG patients. However, CEA may have more beneficial effects on cognition than CABG, specifically in executive functions mainly operated by the prefrontal lobes. In addition, the results underline that POCD is a heterogeneous condition and dependent on type of revascularization surgery.

Physical activity and health-related quality of life among high-risk women for type 2 diabetes in the early years after pregnancy.

BACKGROUND: Previous studies have shown that physical activity (PA) correlates positively with health-related quality of life (HRQoL) in the general population. Few studies have investigated associations between device-measured PA and HRQoL among premenopausal women at risk for type 2 diabetes (T2D). In addition to physical well-being, general well-being improved by PA has been suggested to strengthen PA's benefits in reducing metabolic diseases. The aim of this study was to examine the associations between PA and HRQoL (general and dimensions) among high-risk women in the early post-pregnancy years when T2D risk is highest and to estimate whether current obesity or prior gestational diabetes (GDM) modified these associations. METHODS: This cross-sectional study of high-risk women [body mass index (BMI) ≥ 30 kg/m2 and/or prior GDM)]4-6 years after delivery measured sleep, sedentary time, daily steps, and light (LPA), moderate-to-vigorous (MVPA), and vigorous PA (VPA) with the SenseWear ArmbandTM accelerometer for seven days and HRQoL with the 15D instrument. RESULTS: The analyses included 204 women with a median (IQR) age of 39 (6.0) years and a median BMI of 31.1 kg/m2 (10.9). 54% were currently obese (BMI ≥ 30 kg/m2), and 70% had prior gestational diabetes (GDM+). Women with obesity had lower PA levels than women with normal weight or overweight (p < 0.001) but there was no difference between the GDM+ or GDM- women. Women with both current obesity and GDM+ had highest sedentary time and lowest PA levels. The whole sample's median 15D score was 0.934 (IQR 0.092), lower among women with obesity compared to the others (p < 0.001), but not different between GDM+ or GDM-. There was a positive correlation between VPA (adjusted rs = 0.262 p = 0.001) and the 15D score. After grouping according to BMI (< and ≥ 30 kg/m2), the associations remained significant only in women without obesity. Among them, sleep, total steps, MVPA, and VPA were positively associated with 15D. CONCLUSIONS: Higher PA levels are associated with better HRQoL among high-risk women with normal weight and overweight but no differences were found among women affected by obesity in the early years after pregnancy. Trial registration Ethics committees of Helsinki University Hospital (Dnro 300/e9/06) and South Karelian Central Hospital (Dnro 06/08).

Obesity and the Risk of Cryptogenic Ischemic Stroke in Young Adults.

OBJECTIVES: We examined the association between obesity and early-onset cryptogenic ischemic stroke (CIS) and whether fat distribution or sex altered this association. MATERIALS AND METHODS: This prospective, multi-center, case-control study included 345 patients, aged 18-49 years, with first-ever, acute CIS. The control group included 345 age- and sex-matched stroke-free individuals. We measured height, weight, waist circumference, and hip circumference. Obesity metrics analyzed included body mass index (BMI), waist-to-hip ratio (WHR), waist-to-stature ratio (WSR), and a body shape index (ABSI). Models were adjusted for age, level of education, vascular risk factors, and migraine with aura. RESULTS: After adjusting for demographics, vascular risk factors, and migraine with aura, the highest tertile of WHR was associated with CIS (OR for highest versus lowest WHR tertile 2.81, 95%CI 1.43-5.51; P=0.003). In sex-specific analyses, WHR tertiles were not associated with CIS. However, using WHO WHR cutoff values (>0.85 for women, >0.90 for men), abdominally obese women were at increased risk of CIS (OR 2.09, 95%CI 1.02-4.27; P=0.045). After adjusting for confounders, WC, BMI, WSR, or ABSI were not associated with CIS. CONCLUSIONS: Abdominal obesity measured with WHR was an independent risk factor for CIS in young adults after rigorous adjustment for concomitant risk factors.

Breast Reconstruction-Prospective Follow up on Breast Cancer Patients' Health-Related Quality of Life.

BACKGROUND: Analysing the results of breast reconstruction is important both in terms of oncological safety and health-related quality of life (HRQoL). Immediate breast reconstruction (IBR) is thought to be prone to complications and heavy for patients with no time to adapt to having cancer. Delayed reconstruction (DR) is an option after primary surgery and oncological treatments, but requires patients to go through two recovery periods after surgery. METHODS: A prospective study of 1065 breast cancer patients with repeated measurement of HRQoL with both generic (15D) and disease specific (EORTC QLQ C-30 BR23) measuring tools included 51 IBR patients and 41 DR patients. These patients' HRQoL and reconstruction methods were studied in more detail alongside with clinical data to determine HRQoL levels for patients with IBR and those with mastectomy and DR during a 24-month follow-up. Measuring points were baseline, 3, 6, 12 and 24 months. RESULTS: Most frequent techniques used were abdominal flaps (IBR n = 16, DR n = 14), latissimus dorsi flaps (LD) (IBR n = 19, DR n = 10), implants (IBR n = 12) and fat grafting (DR n = 6). Smaller groups were excluded from group comparisons. Approximately one third of the patients encountered complications. Symptom scores did not differ between reconstruction methods. DR patients had better overall HRQoL at 12 months, but at 24 months the situation had changed in favour of IBR. Both approaches of reconstructive surgery produced good HRQoL with no significant differences between the approaches studied.

Behavioral therapy is superior to follow-up without intervention in patients with supragastric belching-A randomized study.

BACKGROUND: Behavioral therapy (BT) has been proven effective in the treatment of supragastric belching (SGB) in open studies. The aim was to compare BT to follow-up without intervention in patients with SGB in a randomized study. METHODS: Forty-two patients were randomized to receive 5 sessions of BT, comprising diaphragmatic breathing exercises, or to follow-up without intervention. Patients were evaluated at 6 months, at which point the control group was also offered BT and evaluated after another 6 months. The frequency and intensity of belching and mental well-being were evaluated with a visual analog scale (VAS). Depression, anxiety, and health-related quality of life (HRQoL) were evaluated with four questionnaires: BDI, BAI, 15D, and RAND-36. KEY RESULTS: The frequency and intensity of SGB were significantly lower in the therapy group (n = 19) than in the control group (n = 18) at the 6-month control (p < 0.001). When all patients (n = 36) were evaluated 6 months after BT, in addition to relief in the frequency and intensity of belching (p < 0.001), mental well-being had also improved (p < 0.05). Of all 36 patients, 27(75%) responded to BT. Depression scores were lower after therapy (p < 0.05). Only minor changes occurred in anxiety and HRQoL. CONCLUSIONS AND INFERENCES: Behavioral therapy is superior to follow-up without intervention in patients with SGB in reducing belching and depression; it also improves mental well-being but has only a modest effect on anxiety and HRQoL.