Browsing by Subject "quality of life"

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  • Ollila, Meri-Maija; Piltonen, Terhi T.; Tapanainen, Juha S.; Morin-Papunen, Laure (2020)
    Women with polycystic ovary syndrome (PCOS) in their reproductive years age present with metabolic dysfunction and thus increased likelihood of long-term health consequences and diminished well-being in later life. Due to their larger ovarian reserve, however, they may experience menopause at later age and protection from metabolic and cardiovascular diseases. Moreover, previous studies have indicated that late reproductive aged, normal-weight women with PCOS do not seem to have the expected high risk for type 2 diabetes (T2D), as previously thought. Health related quality of life (HRQoL), nevertheless, is decreased in women with PCOS up until late fertile age, warranting attention and actions from the health care personnel. Given conflicting reports regarding the risk of cardiovascular diseases, future research with well characterized and adequately sized PCOS populations are needed as well as studies aiming to improve their HRQoL.
  • Levola, Jonna; Eskelinen, Saana; Pitkanen, Tuuli (2020)
    Background: Alcohol and substance use disorders (SUDs) are known to be associated with various health problems and somatic comorbidities however, not much is known on how individuals with SUDs themselves view their own health. Depression is common in SUDs and it is also associated with various health problems. The aim of this study was to assess how individuals undergoing inpatient treatment for SUDs perceived their health status and quality of life (QoL) and how having symptoms of depression affected these perceptions. Methods: Data regarding a convenience sample of eighty inpatients with a diagnosis of alcohol or substance dependence were analyzed. Data were collected through a clinical interview and validated questionnaires. Results: Individuals undergoing inpatient treatment for SUDs reported various somatic comorbidities and their self-rated health was moderate. Back pain, high blood pressure and liver disease were the most commonly reported somatic comorbidities. More severe symptoms of depression were associated with poorer self-rated health, more comorbidities and poorer QoL after adjusting for potential confounders such as age. Conclusions: Individuals with SUDs have many health-related concerns and their QoL is impaired. Symptoms of depression are associated with self-rated health and QoL in this population.
  • Ehrnrooth, Anna (Helsingfors universitet, 2016)
    Goals As the proportion of the elderly population increases, studying biomarkers of cellular aging have become an important focus of research. However, these risk factors of age-related diseases have been difficult to identify. Recently an estimator of cellular aging, based on DNA methylation levels, the DNAm age, has been developed, and it has been linked to risk for both greater mortality and physical and mental health diseases. Effects of early life stress and later health on DNAm age have not yet been studied together. We set out to study, if early life stress and later quality of life and depression each separately or in combination associate with DNAm age. Methods The participants comprised Finnish males, of which 83 were separated from their families during the World War 2, and 83 non-separated controls belonging to the Helsinki Birth Cohort Study. Genome-wide methylation profiles, Rand-36 quality of life and BDI-1 depression inventory were assessed during years 2001-2004. DNAm age was estimated using the Horvath procedure. Associations of separation status, Rand-36 scores and BDI scores on DNAm age were studied with linear regression after adjusting for chronological age, cell type counts, tobacco smoking and frequency of alcohol consumption. Results and conclusions The separation status did not associate with the DNAm age. The Rand-36 Bodily Pain –scale associated differently with DNAm age in the separated group compared to the non-separated group. In analyses stratified for separation status, mild-severe depressive symptoms associated with lower DNAm age in the separated group. Similarly, lower quality of life on Rand-36 Role Functioning-scale and Emotional and Role Functioning Physical -scale associated with lower DNAm age in the separated group. Results are in line with previous studies, which have shown that early life stress doesn't associate with the DNAm age, but the cumulative total life stress and later adulthood diseases do associate with the DNAm age. This study brings novel information of the associations of early life stress and later depression symptomatology and psychosocial quality of life on the DNAm age, and suggests the early life stress and later depression and poorer psychosocial quality of life to have a cumulative effect on the DNAm age. More studies and longitudinal follow-up is needed to clarify the role of DNAm age as a biomarker of cellular aging, especially when examining the effects of early life stress exposure and later health together.
  • Honkanen, Nina (Helsingin yliopisto, 2021)
    Purpose: To assess the long-term outcome of breast reconstructions with special focus on chronic postsurgical pain (CPSP) in a larger cohort of breast cancer survivors. Materials and methods: A cross-sectional study on 121 women with mastectomy and breast reconstruction after mean 2 years 4 months follow up. The mean time from breast reconstruction to the follow-up visit was 4 years 2 months. We studied surveys on pain (Brief Pain Inventory, BPI and Douleur Neuropathique 4, DN4), quality of life (RAND-36), sleep (insomnia severity questionnaire, ISI), mood (Beck’s Depression Index, BDI; Hospital Anxiety and Depression Scale, HADS), and a detailed clinical sensory status. Patients were divided into three groups: abdominal flap (DIEP, fTRAM, and pTRAM), dorsal flap (LD and TDAP), and other (TMG, implant). Clinically meaningful pain was defined ≥ 4/10 on a numeric rating scale (NRS). We used patients’ pain drawings to localize the pain. We assessed preoperative pain NRS from previous data. Results: 106 (87.6%) of the patients did not have clinically meaningful persistent pain. We found no statistically significant difference between different reconstruction types with regards to persistent pain (p = 0.40), mood (BDI-II, p = 0.41 and HADS A, p = 0.54) or sleep (p = 0.14), respectively. Preoperative pain prior to breast reconstruction surgery correlated strongly with moderate or severe CPSP. Conclusion: Moderate to severe CPSP intensity was present in 14% of patients. We found no significant difference in the prevalence of pain across different reconstruction types. Preoperative pain associated significantly with postoperative persistent pain.
  • COSCA collaborators; Haywood, Kirstie; Castren, Maaret (2018)
    Cardiac arrest effectiveness trials have traditionally reported outcomes that focus on survival. A lack of consistency in outcome reporting between trials limits the opportunities to pool results for meta-analysis. The COSCA initiative (Core Outcome Set for Cardiac Arrest), a partnership between patients, their partners, clinicians, research scientists, and the International Liaison Committee on Resuscitation, sought to develop a consensus core outcome set for cardiac arrest for effectiveness trials. Core outcome sets are primarily intended for large, randomized clinical effectiveness trials (sometimes referred to as pragmatic trials or phase III/IV trials) rather than for pilot or efficacy studies. A systematic review of the literature combined with qualitative interviews among cardiac arrest survivors was used to generate a list of potential outcome domains. This list was prioritized through a Delphi process, which involved clinicians, patients, and their relatives/partners. An international advisory panel narrowed these down to 3 core domains by debate that led to consensus. The writing group refined recommendations for when these outcomes should be measured and further characterized relevant measurement tools. Consensus emerged that a core outcome set for reporting on effectiveness studies of cardiac arrest (COSCA) in adults should include survival, neurological function, and health-related quality of life. This should be reported as survival status and modified Rankin scale score at hospital discharge, at 30 days, or both. Health-related quality of life should be measured with >= 1 tools from Health Utilities Index version 3, Short-Form 36-Item Health Survey, and EuroQol 5D-5L at 90 days and at periodic intervals up to 1 year after cardiac arrest, if resources allow.
  • Hulkkonen, S.; Repo, J. P.; Häkkinen, A.; Karppinen, J.; Ryhänen, J. (2020)
    Background and Aims: Michigan Hand Outcomes Questionnaire is a widely used patient-reported outcome measure in hand surgery. The aim of this study was to translate and validate the Michigan Hand Outcomes Questionnaire into Finnish for Finnish patients with hand problems following international standards and guidelines. Material and Methods: The original English Michigan Hand Outcomes Questionnaire was translated into Finnish. Altogether, 115 patients completed the Finnish Michigan Hand Outcomes Questionnaire, and reference outcomes: Disabilities of the Arm and Shoulder, EQ-5D 3L and pain intensity on a visual analog scale. Grip and key pinch forces were measured. After 1-2 weeks, 63 patients completed the Finnish Michigan Hand Outcomes Questionnaire the second time. The Michigan Hand Outcomes Questionnaire was analyzed for internal consistency, repeatability, correlations with the reference outcomes, and factor analysis. Results: Cronbach's alpha ranged from 0.90 to 0.97 in all the Michigan Hand Outcomes Questionnaire subscales, showing high internal consistency. The intraclass correlation coefficient showed good to excellent test-retest reliability ranging from 0.66 to 0.91 in all the Michigan Hand Outcomes Questionnaire subscales. In factor analysis, the structure with six subscales was not confirmed. All the subscales correlated with Disabilities of the Arm and Shoulder score, and five subscales correlated with EQ-5D index. Conclusion: The Finnish version of the Michigan Hand Outcomes Questionnaire showed similar properties compared to the original English version and thus can be used as patient-reported outcome measure for Finnish patients with hand problems.
  • Urtamo, Annele; Jyväkorpi, Satu; Strandberg, Timo (2019)
    Successful ageing has become an important concept to describe the quality of ageing. It is a multidimensional concept, and the main focus is how to expand functional years in a later life span. The concept has developed from a biomedical approach to a wider understanding of social and psychological adaptation processes in later life. However, a standard definition of successful ageing remains unclear and various operational definitions of concept have been used in various studies. In this review we will describe some definitions and operational indicators of successful ageing with a multidimensional approach.
  • Kluger, Nicolas; Pankakoski, Anna; Panelius, Jaana (2020)
    Bullous pemphigoid is the most common autoimmune subepidermal blistering disease of the skin and mucous membranes. It is also associated with high mortality and poor prognosis due to advanced age of the patients and coexisting comorbidities. There is a dearth of data in the literature regarding depression and anxiety among those patients. The objective of this brief review is to discuss the intertwining relationship between depression and anxiety with bullous pemphigoid.
  • Lehto, Maria (Helsingin yliopisto, 2020)
    Helsinki Chronic Pain Index (HCPI) is a validated clinical metrology instrument used to measure canine chronic pain. In pain assessment, it is recommended to use validated instruments, and behavioural changes provide the best basis for pain measurement. A measuring instrument is valid when it does what it is intended to do. Validation can be done using many different methods. The aim of this study was to investigate which items of the HCPI are still useful and psychometrically test a new structure of the HCPI (HCPI-E3) after four new questions had been added to the test. The data consisted of 1140 internet-based questionnaire responses from dog owners. The study dogs were divided into different groups based on their reported amount of pain symptoms, pain medications, and other treatments to relieve pain. Based on the comparison of different items, five possible structures of the new HCPI were developed and tested with different statistical methods. Based on the initial item comparison, the “vocalization” item was deleted from the HCPI. Overall, the “ease in” locomotion items showed better criterion validity than the “willingness to” items. Both of the “jumping” items performed excellent compared to the other locomotion item pairs, as well as the new structure containing both “jumping” items and only the “ease in” items from the other locomotion items. Thus, this structure was chosen to be the best candidate for the new structure of the HCPI. Jumping is an easily assessed activity, which does not occur too frequently, possibly making it easier to measure the dog’s willingness to do it compared to gait changes (walking, trotting, and galloping). The HCPI-E3 is a reliable tool for canine chronic pain measurement; however, future validation in the form of repeatability and reliability are still needed.
  • Moberg, Nora (Helsingfors universitet, 2016)
    Music interventions carried out by caregivers of persons with dementia (PWDs) have lately become the focus of music rehabilitation in dementia research. Dementia can be burdening for caregivers and it may disrupt the relationship between PWDs and caregivers. The aim of this thesis was to determine whether 1) awareness deficits frequently observed in PWDs manifest in rating discrepancies between PWDs and their caregivers when rating mood and quality of life of PWDs or if these differences are primarily explained by caregiver burden and 2) a caregiver-based music intervention can attenuate the rating discrepancies. In the current study, 89 PWD-caregiver dyads were randomly allocated in three groups: singing group, music listening group, and control group. Cognition, mood, and quality of life of the PWDs were assessed at baseline, immediately after the intervention, and 6 months after intervention. Discrepancy scores were calculated between the PWDs' and caregivers' ratings in Cornell-Brown Scale for Quality of Life in Dementia (CBS) and Quality of Life in Alzheimer's Disease (QOL-AD). Correlations of the discrepancy scores to intervention outcomes and baseline PWD and caregiver characteristics were examined. Differences between intervention groups in CBS and QOL-AD discrepancies were analyzed with ANOVA. QOL-AD discrepancy was associated with dementia severity at baseline. CBS discrepancies were consistently associated with caregiver burden, higher discrepancies corresponding to higher burden. The intervention groups did not show any differences in change in the discrepancy scores in mixed-model ANOVAs. Further research with more focused measures is needed to determine whether music interventions can alleviate awareness deficits and/or PWD-caregiver discrepancies and, regarding the latter, to reveal the exact route of the effect.
  • Cork, Michael J.; Eckert, Laurent; Simpson, Eric L.; Armstrong, April; Barbarot, Sebastien; Puig, Luis; Girolomoni, Giampiero; de Bruin-Weller, Marjolein; Wollenberg, Andreas; Kataoka, Yoko; Remitz, Anita; Beissert, Stefan; Mastey, Vera; Ardeleanu, Marius; Chen, Zhen; Gadkari, Abhijit; Chao, Jingdong (2020)
    Background: Atopic dermatitis (AD) profoundly affects quality of life (QoL). Dupilumab significantly improves clinical outcomes, is well tolerated, and approved to treat inadequately controlled moderate-to-severe AD in adults; however, its effect on patient-reported outcomes (PROs) is not fully characterized. Objective: To evaluate the impact of dupilumab on patient-reported AD symptoms and QoL. Methods: Pooled data were analyzed from two identically designed phase 3 studies, LIBERTY AD SOLO 1 (NCT02277743) and SOLO 2 (NCT02277769), assessing the following PROs: Peak Pruritus Numerical Rating Scale (NRS), Pruritus Categorical Scale, SCORing AD (SCORAD), Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), Hospital Anxiety and Depression Scale (HADS), five-dimension EuroQoL questionnaire (EQ-5D), and patient-assessed disease status and treatment effectiveness. Results: Dupilumab rapidly improved (vs. placebo) Peak Pruritus NRS scores by day 2 (p <.05), anxiety and depression (HADS), and QoL (DLQI) by week 2, and maintained through week 16 (p <.0001). At week 16, more dupilumab-treated than placebo-treated patients reported improvement in SCORAD itch and sleep, and no pain/discomfort (EQ-5D) (p <.0001). Limitations: Cultural differences of translated PROs. Conclusion: Dupilumab had a significant, positive impact on AD symptoms, including itch, sleep, pain, anxiety and depression, and QoL in adults with moderate-to-severe AD.
  • Lucendo Noriega, Alicia (Helsingin yliopisto, 2022)
    Objectives. The world population aged over 60 years is estimated to increase to 1.4 billion by 2030. This increasing trend evidences the current need for promoting healthy ways of living and aging. Previous research has studied music as a protective factor for several aspects in aging-associated neurological illnesses. This thesis aims at researching if healthy amateur choir singers and controls across age in adulthood differ in self-reported cognitive functions, social support and quality of life. It is hypothesized that amateur choir singers will report higher values of the three aspects mentioned above. Methods. Participants (N=93) were recruited from two general population groups, amateur choir singers (N = 54) and controls (N = 46), from 3 age groups split as follows: young adults: 20–39 years (N=34, mean = 29.79, SD = 5.65); middle-aged adults: 40–59 years (N=32, mean = 50.31, SD = 6.47); and older adults: 60–90 years (N=27, mean = 69.37, SD = 7.62). Outcome measures were questionnaires on quality of life (WHO-QOL-BREF), social support (Social Provisions Scale, SPS), cognitive functioning (Cognitive Failures Questionnaire, CFQ; Prospective and Retrospective Memory Questionnaire, PRMQ). Statistical analyses were performed with SPSS. Results and conclusions. The variable “total years of education” was included as a covariate when comparing the age groups, due to significant difference in the demographic pre-analysis. When studying the effects of amateur choir singing (choir vs controls), none of the results were significant. In comparing the three age groups (young, middle-aged, old), significant group differences were found in all the domains of theCFQ (cognitive failures) questionnaire except for Names, with young adults scoring higher (indicating more cognitive failures) than the middle-aged and older adults. A significant singing x age interaction was observed in all CFQ domains (except Names) as well as in the Reliable alliance subdomain of the SPS, with choir singers showing a more positive trend (less cognitive failures, more social support) across the age groups compared to the control group. These findings suggest a possible protective effect of amateur choir singing on subjective cognitive and social functioning in aging, which should be further studied.
  • Tenhola, Heli (Helsingfors universitet, 2013)
    Prostate cancer is the most common cancer among men in Finland. Today, new prostate cancers are diagnosed in an early phase of the disease when the cancer is still local and effectiveness of the treatments good. There are many effective treatment options for localised prostate cancer but all of them cause multiple side effects. No comprehensive information about prostate cancer patients' experiences, treatment consequences and outcomes has been available. National Institute for Health and Welfare (THL) carried out a nationwide survey to prostate cancer patients diagnosed in 2004. The questionnaire was sent by mail in 2009. Patients were asked to report their experiences during the diagnosis and treatment selection (prostatectomy, hormone therapy, external beam radiation, brachytherapy, surveillance). They were asked about amount and harmfulness of side effects and satisfaction with outcome of the treatment. An association between the side effects and satisfaction with the treatment outcome was also studied. A total of 1239 responses were accepted for the study (response rate 73%). All treatments caused several side effects, and up to half of the patients had some adverse effect still present at the time of the survey. Most of the side effects concerned urinary or sexual dysfunction, in external beam radiation also bowel dysfunction. All treatments caused sexual dysfunction, but radiation therapy less than the other treatments. Side effects caused by hormone therapy were specific for this treatment, like hot flashes and mood disturbances. Patients treated with prostatectomy were least satisfied with the outcome of the treatment and dissatisfaction was mostly associated with sexual and urinary dysfunction. Patients treated with radiation therapy were most satisfied with the outcome. Urinary and bowel dysfunction impaired the satisfaction in patients treated with external beam radiation. All prostate cancer treatments cause plenty of potentially harmful side effects that may be challenging for psychological and psychosocial well-being of the patients. Thus, both treatment modalities and means to support well-being of the patients should be developed further. Actions that enhance well-being and prevent and relieve side effects should be an essential part of standard clinical procedures for every prostate cancer patient.
  • Paavola, Mika; Malmivaara, Antti; Taimela, Simo; Kanto, Kari; Järvinen, Teppo L. N. (2017)
    Introduction: Arthroscopic subacromial decompression (ASD) is the most commonly performed surgical intervention for shoulder pain, yet evidence on its efficacy is limited. The rationale for the surgery rests on the tenet that symptom relief is achieved through decompression of the rotator cuff tendon passage. The primary objective of this superiority trial is to compare the efficacy of ASD versus diagnostic arthroscopy (DA) in patients with shoulder impingement syndrome (SIS), where DA differs only by the lack of subacromial decompression. A third group of supervised progressive exercise therapy (ET) will allow for pragmatic assessment of the relative benefits of surgical versus non-operative treatment strategies. Methods and Analysis: Finnish Subacromial Impingement Arthroscopy Controlled Trial is an ongoing multicentre, three-group randomised controlled study. We performed two-fold concealed allocation, first by randomising patients to surgical (ASD or DA) or conservative (ET) treatment in 2:1 ratio and then those allocated to surgery further to ASD or DA in 1:1 ratio. Our two primary outcomes are pain at rest and at arm activity, assessed using visual analogue scale (VAS). We will quantify the treatment effect as the difference between the groups in the change in the VAS scales with the associated 95% CI at 24 months. Our secondary outcomes are functional assessment (Constant score and Simple shoulder test), quality of life (15D and SF-36), patient satisfaction, proportions of responders and non-responders, reoperations/treatment conversions, all at 2 years post-randomisation, as well as adverse effects and complications. We recruited a total of 210 patients from three tertiary referral centres. We will conduct the primary analysis on the intention-to-treat basis. Ethics and Dissemination: The study was approved by the Institutional Review Board of the Pirkanmaa Hospital District and duly registered at The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations. © 2017 Article author(s).
  • Eriksson, Daniel; Karlsson, Linda; Eklund, Oskar; Dieperink, Hans; Honkanen, Eero; Melin, Jan; Selvig, Kristian; Lundberg, Johan (2017)
    Background. A limited number of studies have assessed health related quality of life (HRQoL) in autosomal dominant polycystic kidney disease (ADPKD). Results to date have been conflicting and studies have generally focused on patients with later stages of the disease. This study aimed to assess HRQoL in ADPKD across all stages of the disease, from patients with early chronic kidney disease (CKD) to patients with end-stage renal disease. Methods. A study involving cross-sectional patient-reported outcomes and retrospective clinical data was undertaken April December 2014 in Denmark, Finland, Norway and Sweden. Patients were enrolled into four mutually exclusive stages of the disease: CKD stages 1-3; CKD stages 4-5; transplant recipients; and dialysis patients. Results. Overall HRQoL was generally highest in patients with CKD stages 1-3, followed by transplant recipients, patients with CKD stages 4-5 and patients on dialysis. Progressive disease predominately had an impact on physical health, whereas mental health showed less variation between stages of the disease. A substantial loss in quality of life was observed as patients progressed to CKD stages 4-5. Conclusions. Later stages of ADPKD are associated with reduced physical health. The value of early treatment interventions that can delay progression of the disease should be considered.
  • Nobre, Nuno; Pereira, Marco; Roine, Risto P.; Sutinen, Jussi; Sintonen, Harri (2018)
    We examined how HIV-related self-stigma was associated with different domains of quality of life (QoL), as measured by the World Health Organization Quality of Life in HIV-infected persons instrument (WHOQOL-HIV-Bref), and health-related quality of life (HRQoL) as measured by the generic 15D (15-dimensional measure of HRQoL), to identify the factors associated with self-stigma of people living with HIV (PLWH). The study sample included 440 patients living with HIV followed at the Infectious Disease Clinic of Helsinki University Hospital. Participants with more severe self-stigma reported significantly lower QoL and HRQoL. Male gender, cohabiting with a partner, and disclosure of HIV status were associated with less self-stigma; high education level and financial difficulties were associated with greater self-stigma. Having lived longer with HIV, being unemployed, and living alone were also predictors of self-stigma via financial difficulties. The findings suggest that self-stigma is a complex and multidimensional phenomenon that impacts the HRQoL of PLWH. Psychosocial interventions to enhance the well-being of PLWH are increasingly needed. Copyright (C) 2017 Association of Nurses in AIDS Care
  • Luoto, Kaisa E.; Lindholm, Lars H.; Koivukangas, Antti; Lassila, Antero; Sintonen, Harri; Leinonen, Esa; Kampman, Olli (2021)
    Background and Aim: In psychiatric clinical practice, comorbidity of depression and alcohol use disorder (AUD) is common. Both disorders have a negative impact on health-related quality of life (HRQoL) in general population. However, research on the impact of comorbid AUD on HRQoL among clinically depressed patients is limited. The purpose of this study was to explore the impact of a psychosocial treatment intervention on HRQoL for depressive patients in specialized psychiatric care with a special focus on the impact of AUD on HRQoL. Material and Methods: Subjects were 242 patients of the Ostrobothnia Depression Study ( Identifier NCT02520271). Patients referred to specialized psychiatric care who scored at least 17 points on the Beck Depression Inventory at baseline and who had no psychotic disorders were included in the ODS. The treatment intervention in ODS comprised behavioral activation for all but began with motivational interviewing for those with AUD. HRQoL was assessed regularly during 24-month follow-up by the 15D instrument. In the present study, HRQoL of ODS patients with or without AUD was compared and the factors explaining 15D score analyzed with a linear mixed model. In order to specify the impact of clinical depression on HRQoL during the early phase of treatment intervention, a general population sample of the Finnish Health 2011 Survey was used as an additional reference group. Results: HRQoL improved among all ODS study sample patients regardless of comorbid AUD during the first year of follow-up. During 12–24 months of follow-up the difference between groups was seen as HRQoL continued to improve only among the non-AUD patients. A combination of male gender, anxiety disorder, and AUD was associated with the poorest HRQoL in this sample. In combined sample analyses with the reference group, clinical depression had an impact on HRQoL in short-term follow-up regardless of the treatment intervention. Conclusions: This study suggests that, in terms of improvement in HRQoL, the heterogenous group of depressive patients in specialized psychiatric care can be successfully treated with behavioral activation in combination with motivational interviewing for those with AUD. Clinical Trial Registration: Identifier: NCT02520271. Ostrobothnia Depression Study (ODS). A Naturalistic Follow-up Study on Depression and Related Substance Use Disorders. (2015). Available online at:
  • Bonnet, Damien; Berger, Felix; Jokinen, Eero; Kantor, Paul F.; Daubeney, Piers E. F. (2017)
    BACKGROUND Heart rate reduction as a therapeutic target has been investigated in adults with heart failure (HF). Ivabradine has shown promising efficacy, but has not been evaluated in children. Currently, treatment recommendations for chronic pediatric HF are based mainly on chronic HF guidelines for adults. OBJECTIVES The authors explored the dose-response relationship of ivabradine in children with dilated cardiomyopathy and symptomatic chronic HF. The primary endpoint was >= 20% reduction in heart rate from baseline without inducing bradycardia or symptoms. METHODS This was a randomized, double-blind, placebo-controlled, phase II/III study with 12 months of follow-up. Children (n = 116) receiving stable HF therapy were randomized to either ivabradine or placebo. After an initial titration period, the dose was adjusted to attain the primary endpoint. Left ventricular function (echocardiography), clinical status (New York Heart Association functional class or Ross class), N-terminal pro-B-type natriuretic peptide, and quality of life (QOL) were assessed. RESULTS The primary endpoint was reached by 51 of 73 children taking ivabradine (70%) versus 5 of 41 taking placebo (12%) at varying doses (odds ratio: 17.24; p <0.0001). Between baseline and 12 months, there was a greater increase in left ventricular ejection fraction in patients taking ivabradine than placebo (13.5% vs. 6.9%; p = 0.024). New York Heart Association functional class or Ross class improved more with ivabradine at 12 months than placebo (38% vs. 25%; p = 0.24). There was a trend toward improvement in QOL for ivabradine versus placebo (p = 0.053). N-terminal pro-B-type natriuretic peptide levels decreased similarly in both groups. Adverse events were reported at similar frequencies for ivabradine and placebo. CONCLUSIONS Ivabradine safely reduced the resting heart rate of children with chronic HF and dilated cardiomyopathy. Ivabradine's effect on heart rate was variable, highlighting the importance of dose titration. Ivabradine treatment improved left ventricular ejection fraction, and clinical status and QOL showed favorable trends. (Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symptomatic chronic heart failure from ages 6 months to 18 years; ISRCTN60567801) (C) 2017 by the American College of Cardiology Foundation.
  • Talala, Kirsi; Heinävaara, Sirpa; Taari, Kimmo; Tammela, Teuvo L. J.; Kujala, Paula; Stenman, Ulf-Håkan; Malila, Nea; Auvinen, Anssi (2020)
    Background The long-term health-related quality of life (HRQOL) impacts of PCa screening have not been adequately evaluated. We aimed to compare the generic and disease-specific health-related quality of life (HRQOL) among men with prostate cancer in the screening arm with the control arm of the PSA-based prostate cancer screening trial in up to 15 years of follow-up. Materials and methods This study was conducted within population-based Finnish Randomized Study of Screening for Prostate Cancer (FinRSPC). During 1996-1999 80,458 men were randomized to the serum prostate-specific antigen (PSA) screening arm (SA, N = 32 000) and the control arm (CA, N = 48 458). Men in the screening arm were screened at 4-year intervals until 2007. HRQOL questionnaires were delivered to newly diagnosed prostate cancer patients in the screening and control arm 1996-2006 (N = 5128) at the time of diagnosis (baseline), at 3-month, 12-month and 5, 10, and 15-year follow-up. Validated UCLA Prostate Cancer Index (UCLA-PCI) and RAND 36-Item Health Survey were used for HRQOL assessment. The data were analyzed with a random effects model for repeated measures. Results At baseline, men with prostate cancer in the screening arm reported better Sexual Function, as well as less Sexual and Urinary Bother. Long-term follow-up revealed slightly higher HRQOL scores in the screening arm in prostate cancer specific measures at 10-year post diagnosis, but the differences were statistically significant only in Urinary Bother (UCLA-PCI score 77.9; 95% CI 75.2 to 80.5 vs. 70.9; 95% CI 66.8 to 74.9 P = .005).The generic HRQOL scores were comparable between the trial arms. The overall differences in disease-specific or generic HRQOL scores by trial arm did not vary during the follow-up. Conclusion No major differences were observed in HRQOL in men with prostate cancer between the prostate cancer screening and control arms during five to 15-year follow-up.
  • Peltola, Elina; Hannula, Päivi; Huhtala, Heini; Sintonen, Harri; Metso, Saara; Sand, Juhani; Laukkarinen, Johanna; Tiikkainen, Mirja; Schalin-Jäntti, Camilla; Siren, Jukka; Soinio, Minna; Nuutila, Pirjo; Moilanen, Leena; Ebeling, Tapani; Jaatinen, Pia (2021)
    Objective Insulinomas are rare pancreatic neoplasms, which can usually be cured by surgery. As the diagnostic delay is often long and the prolonged hyperinsulinemia may have long-term effects on health and the quality of life, we studied the long-term health-related quality of life (HRQoL) in insulinoma patients. Design, patients and measurements The HRQoL of adults diagnosed with an insulinoma in Finland in 1980-2010 was studied with the 15D instrument, and the results were compared to those of an age- and gender-matched sample of the general population. The minimum clinically important difference in the total 15D score has been defined as +/- 0.015. The clinical characteristics, details of insulinoma diagnosis and treatment, and the current health status of the subjects were examined to specify the possible determinants of long-term HRQoL. Results Thirty-eight insulinoma patients participated in the HRQoL survey (response rate 75%). All had undergone surgery with a curative aim, a median of 13 (min 7, max 34) years before the survey. The insulinoma patients had a clinically importantly and statistically significantly better mean 15D score compared with the controls (0.930 +/- 0.072 vs 0.903 +/- 0.039, P = .046) and were significantly better off regarding mobility, usual activities and eating. Among the insulinoma patients, younger age at the time of survey, higher level of education and smaller number of chronic diseases were associated with better overall HRQoL. Conclusions In the long term, the overall HRQoL of insulinoma patients is slightly better than that of the general population.