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Background: Health-related quality of life (HRQoL) following total hip and knee arthroplasty (THA/TKA) may decline more in Asian countries due to lifestyle and housing factors compared with patients in Western countries., Aims: To evaluate the psychometric properties of the Japanese version of 15D and clarify the characteristics of HRQoL in Japanese patients who underwent THA/TKA compared with Finnish patients., Methods: This longitudinal study included 182 patients between 2019 and 2021. Patients' HRQoL was measured using the 15D preoperatively and 3 months postoperatively. Student's t-tests were used to compare lifestyles between Japan and Finland., Results: The Japanese version of the 15D showed good internal consistency, reliability, construct validity, and responsiveness. Patients with many steps inside their house had worse HRQoL in the dimensions of mobility, distress, and vitality in Japan. There were significant differences in mobility, distress, vitality, and sexual activity dimensions between Japan and Finland 3 months postoperatively., Conclusions: The lower HRQoL in Japan in the dimensions of mobility, distress, and vitality is likely due to Japan's traditional housing structure with many steps. Identifying differences in cultural and psychological characteristics, as well as by residential setting, will enable health care providers to help patients improve their HRQoL., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Chest masculinization is the most common surgical intervention in transgender men. Studies indicate good patient-reported postoperative satisfaction, but only recently has a patient-reported outcome instrument, the BODY-Q Chest module, been developed and validated for this patient group. This study aimed to evaluate postoperative patient-reported satisfaction and health-related quality of life (HRQoL) using the BODY-Q Chest module and the 15D after surgical chest masculinization in transgender men. The data comprised all patients receiving chest masculinization from 2005 to 2018. The patients were invited by letter to complete the BODY-Q Chest module and the 15D questionnaire in May 2020. Of the 220 patients invited, 123 completed the survey, resulting in a response rate of 56%. The median chest and nipple scores were 76 and 68 out of 100, respectively. The number of secondary corrections was negatively associated with the chest score (p value < 0.001). The 15D index score was lower compared with the age-standardized male population (p value < 0.001), but similar to the age-standardized female population. Psychiatric comorbidity was associated with lower 15D index scores (p value < 0.001). There were no statistically significant differences between the BODY-Q Chest module scores or the 15D index score among the different surgical techniques. The postoperative satisfaction with chest masculinization was good and in line with previous literature. HRQoL resembles that of the reference population. The periareolar technique is not associated with better satisfaction despite causing less scar burden. The negative association between the chest score and number of secondary corrections is unsettling and requires further examination in a prospective setting., (Copyright © 2024 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Background: The aim of this study was to investigate the influence of primary congenital hypothyroidism (CH) on quality of life, level of education and socioeconomic status (SES)., Methods: Two independent study cohorts, a national and a regional, were collected from Finnish national registers and patient records. Data on social security benefits, SES, marital status, and education were collected from Statistics Finland. Health-related quality of life (HRQoL) was studied in the regional patient cohort with the standardized 15D and 16D instruments., Results: There were no statistically significant differences in education level, marital status, or SES between CH patients (n = 40) and their matched controls at the age of 25 years. The mean 15D score was both statistically significantly and clinically importantly lower in CH patients (n = 29) than controls (0.904 vs. 0.953, p = 0.008). CH patients reported significantly lower scores across various dimensions of physical and mental HRQoL, including breathing, sleeping, speech, excretion, mental function, distress, and vitality. The mean 16D score was lower in CH patients compared to controls (0.917, vs. 0.947), but without statistical significance., Conclusion: SES of CH patients did not differ from matched controls. Thus, most CH patients integrate well into society, but their HRQoL is impaired., Impact: Most patients with primary congenital hypothyroidism integrate well into society. In the current study, their socioeconomic and marital status did not differ from matched controls at the age of 25 years. However, health-related quality of life measured using 15D instrument was impaired. Every fourth patient reported that congenital hypothyroidism influenced everyday life., (© 2024. The Author(s).)

Objective: Spontaneous intracranial hypotension (SIH) is an important cause of orthostatic headaches caused by spinal CSF leaks. It has a strong negative impact on patients' socioeconomic status and health-related quality of life (HRQOL). This study aimed to analyze the impact of surgical and endovascular treatments on patients' HRQOL., Methods: The authors conducted a prospective, observational cohort study that included all patients treated for SIH with microsurgery or embolization, depending on the type of CSF leak, at their institution between April 2022 and May 2023. Patients were asked to complete a specifically designed questionnaire, as well as the 15D HRQOL questionnaire, before and 3 months after treatment., Results: A total of 21 patients (14 female; mean age 51.7 years) were treated in the study period. There were 12 (57%) type 1 leaks, 3 (14%) type 2, and 6 (29%) type 3. While 20 (95.2%) leaks were localized in the thoracic spine, only 1 (4.8%) was found in the lumbar spine. All patients completed the questionnaires. Fifteen (71.4%) patients underwent microsurgery and 6 (28.6%) endovascular embolization. The mean 15D score improved from 0.802 before to 0.889 after treatment (p = 0.013). Compared with an age- and sex-matched general population, HRQOL was significantly impaired in patients with SIH before treatment. After treatment, the authors found no significant difference in the overall HRQOL between patients and the healthy population. Mean headache intensity on a numeric rating scale improved from 8.1 before treatment to 2.3 after treatment (p = 0.003). Patients reported that SIH had a notable impact on their social and working life., Conclusions: SIH has a considerable negative impact on HRQOL. Microsurgery or embolization can dramatically improve HRQOL, subjective perception of health, and headache intensity. Therefore, surgical or endovascular treatment should be considered given the improvement observed in HRQOL for patients with SIH.

Purpose: In this randomized controlled trial, we analyzed the effects of a 12-month home-based exercise intervention on the health-related quality of life (HRQoL) of patients with a hip fracture., Methods: Participants (n = 121) aged ≥ 60 years, with a Mini-Mental State Examination (MMSE) score of ≥ 12 and an operated hip fracture, were placed into Exercise (n = 61) or Usual care (n = 60) groups. Physiotherapist-supervised, home-based training was given twice a week over 12 months. HRQoL was assessed using the 15D instrument at baseline and at 3, 6, and 12 months. The total 15D scores and dimension scores were analyzed and compared to national age- and sex-matched reference data., Results: The participants' mean age was 81 years (SD 7), 75% were women, and 61% had a femoral neck fracture. The mean within-group change in total 15D score over 12 months was 0.023 (95% CI: -0.003 to 0.048) in the Usual care group, and 0.028 (CI: 0.003 to 0.054) in the Exercise group (between-group p = 0.76). We found a statistically significant change in total 15D score in the Exercise group, as well as in the dimension scores of mobility and usual activities in both groups. All 15D scores remained below the general population reference level., Conclusion: Exercise training for 12 months did not enhance the HRQoL of home-dwelling patients with hip fractures any more than usual care. In addition, HRQoL remained below the population level in both groups., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Background/aims: To assess the frequency of immediate sequential bilateral cataract surgery (ISBCS) and endophthalmitis during 13-year period in Tays Eye Centre, Tampere University Hospital, Tampere, Finland., Methods: All cataract surgeries performed between 1 January 2008 and 31 December 2020, and all endophthalmitis cases during the same period were searched from electronic patient records. Numbers and frequencies of ISBCS, and complications, including endophthalmitis and vitreous loss, were recorded and compared with unilateral operations., Results: The study included 56 700 cataract surgeries in 34 797 patients of whom 39% (n=13 445) had ISBCS. The median age of the patients was 75 (IQR 68-80, range 0.08-99) years at the time of surgery. The proportion of ISBCS patients increased from 4.2% in 2008 to 46% in 2020. Vitreous loss occurred in 480 (0.9%) of cataract surgeries. There were no postoperative endophthalmitis after cataract surgery (n=0) during the 13-year period., Conclusion: The proportion of patients undergoing ISBCS increased from 4.2% in 2008 to 46% in 2020. No endophthalmitis were found to be associated with ISBCS., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Research on health-related quality of life (HRQoL) is crucial for developing comprehensive palliative care in idiopathic pulmonary fibrosis (IPF). Objectives: To study IPF patients' HRQoL compared with general population and its association with dyspnea in a longitudinal follow-up. Design: Assessment of IPF patients' HRQoL by a generic tool. Comparison of baseline data with the general population and a 30-month follow-up with 6 months intervals. Setting/Subjects: In total, 246 IPF patients were recruited from the Finnish nationwide real-life study, FinnishIPF. Measurements: Modified Medical Research Council (MMRC) dyspnea scale for dyspnea and the generic HRQoL tool 15D for the total and dimensional HRQoL were used. Results: At baseline, the mean 15D total score was lower (0.786, standard deviation [SD] 0.116) in IPF patients than in the general population (0.871, SD 0.043) ( p  < 0.001) and among the IPF patients with MMRC ≥2 compared with those with MMRC <2 ( p  < 0.001). In patients with MMRC ≥2, significant impairment compared with general population existed in 11 dimensions of HRQoL, such as breathing, usual activities, and sexual activity, whereas this was true in only 4 dimensions in MMRC <2 category. Mental function was not impaired in either group. During the follow-up, 15D total score decreased in both MMRC categories ( p  < 0.001) but stayed constantly worse in the MMRC ≥2 group. Seven and two dimensions of HRQoL significantly declined in the categories of MMRC <2 and MMRC ≥2, respectively. Conclusions: Patients with IPF, especially if dyspnea limits everyday life, suffer from widely impaired HRQoL, although self-assessed mental capability is preserved. Integrated palliative care is supported to face the multiple needs of IPF patients.

Background: Prenatal posttraumatic stress symptoms (PTSS), fear of childbirth (FOC), and depressive symptoms have been related to various negative effects during pregnancy, childbirth, and in the postnatal period. This study evaluates the prevalence of PTSS, FOC, depressive symptoms, and health-related quality of life (HRQoL) among pregnant women, their partners, and as couples., Methods: In a cohort of 3853 volunteered, unselected women at the mean of 17th weeks of pregnancy with 3020 partners, PTSS was evaluated by Impact of Event Scale (IES), FOC by Wijma Delivery Expectancy Questionnaire (W-DEQ-A), depressive symptoms by Edinburgh Postnatal Depression Scale (EPDS), and HRQoL by 15D instrument., Results: PTSS (IES score ≥ 33) was identified among 20.2% of the women, 13.4% of the partners, and 3.4% of the couples. Altogether, 5.9% of the women, but only 0.3% of the partners, and 0.04% of the couples experienced symptoms suggestive of phobic FOC (W-DEQ A ≥ 100). Respectively, 7.6% of the women, 1.8% of the partners, and 0.4% of the couples reported depressive symptoms (EPDS ≥ 13). Nulliparous women and partners without previous children experienced FOC more often than those with previous children, but there was no difference in PTSS, depressive symptoms, or HRQoL. Women's mean 15D score was lower than partners' and that of age- and gender-standardized general population, while partners' mean 15D score was higher than that of age- and gender-standardized general population. Women whose partners reported PTSS, phobic FOC, or depressive symptoms, often had the same symptoms (22.3%, 14.3%, and 20.4%, respectively)., Conclusions: PTSS were common in both women and partners, as well as in couples. FOC and depressive symptoms were common in women but uncommon in partners, thus they rarely occurred simultaneously in couples. However, special attention should be paid to a pregnant woman whose partner experiences any of these symptoms., (© 2023. The Author(s).)

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., Competing Interests: Conflict of interest: HS is one of the developers of the 16D. The other author(s) declare no potential conflicts of interest with respect to the research, authorship, or publication of this article., (© 2023 Anne Rissanen et al., published by Sciendo.)

Background: The long-term outcomes of a proximal humeral fracture during adolescence are not well known. We investigated the course of primary treatment for these injuries and the long-term outcomes in adulthood, comparing the outcomes with those from age-matched controls. We also compared outcomes after operative and nonoperative treatment via propensity score matching., Methods: We included children who sustained a proximal humeral fracture between the ages of 10.0 and 16.0 years and underwent treatment between 1995 and 2005. Data from primary treatment episodes were extracted from patient files. The patients were invited to a follow-up visit with outcome assessment and radiographs or to a telephone interview if unable to attend. The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The secondary outcomes were the Simple Shoulder Test (SST), pain at rest and with strenuous use, shoulder range of motion, strength measurements, health-related quality of life (15D), and harms. Participant results were compared with the normal values of an age-matched population. The effect of operative treatment was assessed using propensity score matching and the average treatment effect was calculated., Results: This study included 209 patients (210 fractures). The mean follow-up (and standard deviation) was 13.1 ± 3.2 years. Outcome data were obtained from 152 participants (153 fractures); 78 participants attended the follow-up visit. The primary treatment episodes were uneventful. The mean scores were 2.5 (95% confidence interval [CI], 1.8 to 3.3 [range, 0 to 13]) for the DASH and 11.7 (95% CI, 11.5 to 11.8 [range, 8 to 12]) for the SST. Other outcomes were similarly good. There were no differences in function compared with the normal population values. Propensity matching showed no treatment effect for operative treatment compared with nonoperative treatment., Conclusions: Proximal humeral fractures of adolescents heal well and rarely result in impairments whether treated operatively or nonoperatively., Level of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence., Competing Interests: Disclosure: The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article (http://links.lww.com/JBJS/H497)., (Copyright © 2023 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated. All rights reserved.)

(1) Background: Purpose: The assessment of quality of life is essential to the human condition and can be measured through questionnaires. This study aims to translate and culturally adapt the 15D questionnaire to assess the population's quality of life, as well as explore its relative reliability and internal consistency; (2) Methods: The translation and cultural adaptation of the 15D questionnaire was carried out independently, considering two translations. The synthesis version was applied to eight subjects, distributed by gender. Cognitive interviews were conducted to observe clarity, acceptability, and familiarity with the version of the questionnaire. The final version of the questionnaire, in Portuguese, was again translated into the official language by two translators who had never had contact with the questionnaire. To assess the test-retest reliability and internal consistency of the 15D questionnaire, 43 participants were interviewed; (3) Results: Participants indicated that they had some doubts about dimensions, breathing, and discomfort and symptoms; however, as there were no suggestions for change, the questionnaire had no changes. Items were clear and understandable. Internal consistency was observed using Cronbach's alpha, with values between 0.76 and 0.98. The test-retest reliability values were between 0.77 and 0.97; and (4) Conclusions: The Portuguese version of the 15D questionnaire was proved to be equivalent to the English version and to be reliable for the Portuguese population. This instrument is easy to access and apply.

Background: Depression undermines health-related quality of life (HRQoL). Remission is the central aim of all treatments for depression, but the degree of remission necessary for depressive patients' HRQoL to correspond to the normal range of the general population remains unknown., Methods: The Vantaa Primary Care Depression Study prospectively followed-up a screening-based cohort of depressive primary care patients for 5 years. The Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) was used to diagnose major depressive disorder. HRQoL was measured by the generic 15D instrument at baseline and at 5 years ( N = 106, 77% of baseline patients), and compared with the 15D results of an age-standardized general population sample from the Finnish Health 2011 Survey ( N = 4,157). Receiver operating characteristic analyses determined the optimal Hamilton Depression Rating Scale (HAMD), Beck Depression Inventory (BDI), and Beck Anxiety Inventory (BAI) cut-offs for remission, using the 15D score as the construct validator. Remission was defined as the score at which HRQoL reached the general population range (minimum mean - 1 SD). As age may influence HRQoL, patients older and younger than the median 52 years were investigated separately., Results: For HAMD, the optimal cut-off point score was 8.5, for BDI 10.5, and for BAI 11.5. The differences between the findings of the younger and older patients were small., Limitations: Cross-sectional analysis, small number of patients in the cohort., Conclusion: Depressive primary care patients' HRQoL reaches the normal variation range of the general population when their depression and anxiety scores reach the conventional clinical cut-offs for remission., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Riihimäki, Sintonen, Vuorilehto and Isometsä.)

Background: The effects of radiotherapy (RT) patients' health-related quality of life (HRQoL) are usually compared to those of other treatment modalities instead of HRQoL of the general population in oncological studies. We examined HRQoL of patients with an early prostate cancer (PC) not receiving hormonal treatment up to 3 years after RT using the 15D instrument and the FACT-P questionnaire., Methods: The 15D results were compared to those in the age-standardized general male population (N = 952) using an independent-sample t test. The study population (N = 73) received RT either with 78/2 Gy, 60/3 Gy or 36.25/7.25 Gy fractionation., Results: No significant differences in the mean total HRQoL scores were found between the RT groups and the general male population at any time point. Patients with PC had more depression (P = .015) and distress (P = .029) than the general male population before the treatment and depression up to 3 months after treatment (P = .019), which did not persist at 3 years. The sexual activity dimension had declined by the end of treatment, and this decline persisted 3 years later (P = .033). Excretion functions were worse compared to those in peers at the end of treatment (P < .001) but no longer at 3 months and later after RT. Regarding the FACT-P, HRQoL remained good at 3 years after RT in all the treatment groups and there were no significant differences between the different RT groups at this time point., Conclusion: This study demonstrated that patients treated with RT for early PC had similar HRQoL compared to the age-standardized general male population at 3 years after treatment., (Copyright © 2022. Published by Elsevier Inc.)

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., (© 2023. The Author(s).)

Introduction: Constitutional delay of growth and puberty (CDGP) is the most common reason for delayed puberty in healthy male adolescents. The main indication for medical treatment for this condition is psychosocial burden. However, to the best of our knowledge, no previous study has addressed the impact of puberty-promoting treatment on health-related quality of life (HRQoL) among boys with CDGP., Methods: We investigated HRQoL in 22 boys with CDGP, who participated in a randomized controlled trial in four Finnish pediatric endocrinology outpatient clinics between 2013 and 2017. The boys were randomized to receive either aromatase inhibitor letrozole (2.5mg/day; n=11) or intramuscular testosterone (1mg/kg/every 4 weeks; n=11) for 6 months and followed up to 12 months. HRQoL was assessed with a generic self-assessment 16D © instrument developed and validated for adolescents aged 12 to 15 years. The 16D includes 16 dimensions (vitality, sight, breathing, distress, hearing, sleeping, eating, discomfort and symptoms, speech, physical appearance, school and hobbies, mobility, friends, mental function, excretion and depression). The results were compared with an age-matched reference population that included 163 boys from the Finnish capital-city area. The study protocol is registered to ClinicalTrials.gov (registration number: NCT01797718)., Results: At baseline, the mean 16D score of the CDGP boys was similar to the age-matched reference population (0.95 vs 0.96, p=0.838). However, the physical appearance score (satisfaction with general appearance, height and weight) was significantly lower in the CDGP boys (0.75 vs 0.92, p=0.004) than their peers. Twelve months after treatment, Appearance had improved significantly (0.75 vs 0.87, p=0.004) and no HRQoL dimension was inferior compared to the age-matched reference population., Discussion: In terms of HRQoL, the main impact of delayed puberty was dissatisfaction with physical appearance. Puberty promoting therapy was associated with a positive change in perceived appearance, with no clear difference between low-dose testosterone and letrozole treatments., Competing Interests: HS is one of the developers of the 16D. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be constructed as a potential conflict of interest., (Copyright © 2022 Kariola, Varimo, Huopio, Tenhola, Voutilainen, Kosola, Toppari, Sintonen, Miettinen, Raivio and Hero.)

Objective: Spontaneous intracranial hypotension (SIH), which is often caused by a spinal cerebrospinal fluid leak, is an important cause of disabling headaches. Many patients report devastating changes in their quality of life because of their symptoms. This study aimed to evaluate the impact of SIH on patients' social/ working life and health-related quality of life (HRQoL)., Methods: We included consecutive patients with proven SIH treated at our institution from January 2013 to May 2020. Patients were contacted and asked to complete the 15D questionnaire for the collection of HRQoL data and to provide additional information on their social life status., Results: Of 112 patients, 79 (70.5%) returned the questionnaire and were included in the analysis. Of those, 69 were treated surgically (87.3%), and 10 were managed non-operatively (12.7%). Twenty-five (31.6%) patients reported a severe impact on their partnership, 32 (41.5%) reported a moderate or severe impact on their social life. Forty (54.8%) patients reported sick leave for more than 3 months. The mean 15D score was 0.890 (± 0.114) and significantly impaired compared to an age- and sex-matched general population (p = 0.001), despite treatment. Patients with residual SIH-symptoms (36, 45.6%) had significantly impaired HRQoL compared to those without any residual symptoms (41, 51.9%) (p < 0.001)., Conclusion: SIH had a notable impact on the patients' social life and HRQoL. It caused long periods of incapacity for work, and is therefore, associated with high economic costs. Although all patients were appropriately treated, reduced HRQoL persisted after treatment, underlining the chronic character of this disease., (© 2022. The Author(s).)

Background: Gynecological surgery has many impacts on women's physical and mental health, and efforts to improve recovery from surgery are constantly under evaluation. Resilience is an ability to overcome stressors and adversities, such as traumas and surgeries. This study aimed to explore patients' resilience and psychological symptoms in relation to recovery, health-related quality of life (HRQoL), and pain one year after gynecological surgery., Methods: In a prospective cohort study, we enrolled consecutive elective gynecologic surgery patients who completed questionnaires before and at one year after surgery: the Resilience Scale-25, the 15D instrument of HRQoL (15D), the Life Satisfaction Scale-4, and the Hospital Anxiety and Depression Scale. Their mean 15D scores were compared to those of an age-matched sample of women from the general Finnish population (n = 2743)., Results: We enrolled 271 women who underwent gynecological surgery due to benign (n = 190) and malignant (n = 81) diagnoses. Resilience was equally high in women with benign and malignant diagnoses at both time points. Higher resilience associated with less pain, analgesic use, and better pain relief from the use of pain medication at 12 months after surgery. Pain intensity was similar in the two groups, but patients with benign diseases had less pain at 12 months than before surgery. Before surgery, patients' HRQoL was worse than that of the general population, but at 12 months the mean HRQoL of patients with benign diseases had improved to the same level as that in the general population but had decreased further in patients with malignant diseases. Anxiety was higher and life satisfaction was lower in patients with malignant diseases before surgery. At 12 months, anxiety had decreased in both groups, and life satisfaction had increased in patients with malignant diseases. Depression was similarly low in both groups and time points., Conclusions: Resilience correlated with less pain one year after surgery. After surgery, HRQoL improved in patients with benign diseases but deteriorated in patients with malignant diseases. Patients with low resilience should be identified during preoperative evaluation, and health care professionals should give these patients psychological support to enhance their resilience. Trial Registration ClinicalTrials.gov; registered October 29, 2019; identifier: NCT04142203; retrospectively registered., (© 2022. The Author(s).)

Objective: The aim of the study was to evaluate if Neuro-orthopedic Activity-dependent Plasticity (N.A.P.) therapy combined with standard subterranean pulmonary rehabilitation (SPR) conducted in the salt mine influences the health-related quality of life (HRQoL) and chest mobility in patients with asthma or chronic upper respiratory tracts diseases., Methods: 54 patients enrolled for the study completed a 3-week SPR. The 15D questionnaire, chest mobility and back scratch flexibility tests were conducted before and after SPR. In the study group (N = 23,16 women, 7 men) the N.A.P. therapy was added to SPR, while the control group (N = 31, 21 women and 10 men) completed the SPR program., Results: After the SPR statistically significant improvements were observed on the 15D dimensions of breathing and vitality dimensions, in the chest mobility and back flexibility in both groups. With the baseline gender distribution, age, generic 15D score, chest mobility and back scratch adjusted, the change in the 15D score was 0.068 greater in the study group than in the control group. This difference is clinically important and statistically significant (p = 0.022). There was no statistically significant difference in the chest mobility and back scratch flexibility between the groups., Conclusions: Adding N.A.P. therapy techniques to the SPR program in the underground part of the 'Wieliczka' Salt Mine Health Resort results in a statistically significant and clinically important improvement in the subjects' HRQoL., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Pemphigus is associated with several autoimmune, dermatological, and psychiatric diseases. Previous studies have reported an increasing incidence of pemphigus in Finland, particularly pemphigus foliaceus and erythematosus., Objectives: The aim of this study was to determine the clinical presentation and associated comorbidities in pemphigus patients., Materials & Methods: We retrospectively assessed 66 pemphigus patients in Helsinki University Hospital and, with an age-standardised control group, performed a comparison of the studied comorbidities., Results: The patients displayed a 0.8 female:male distribution and a mean age of 57.4 years. Pemphigus vulgaris (41%), foliaceus (30%), and erythematosus (15%) were the most common subtypes. Hypertension (30%) and dyslipidaemia (21%) were the most prevalent comorbidities. We found a statistically significant association between pemphigus and a past history of, or concurrent malignancies and atopic dermatitis (p = 0.002 and p = 0.028, respectively). No significant difference was observed in the prevalence of cardiovascular disease, asthma, chronic obstructive lung disease, type I or II diabetes mellitus, inflammatory bowel disease, depression, or anxiety. Erosions (65%), bullae (59%), and crusted lesions (55%) were observed in most patients. Half of the patients experienced pruritus before or at diagnosis. Pruritus was associated with pemphigus without mucosal involvement (p = 0.01)., Conclusion: We found a significant association between pemphigus and atopic dermatitis and a history of malignancy. The clinical picture frequently included pruritus. These results support the findings of some recent studies of pruritus occurring more frequently in patients with pemphigus foliaceus and cutaneous pemphigus vulgaris.

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.

Introduction: Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease associated with various comorbidities and diminished quality of life (QoL). Among dermatological conditions, HS is reported to most severely diminish QoL. This study aimed to analyse the health-related QoL (HRQoL) of patients with HS in more detail by using generic to disease-specific HRQoL questionnaires. Correlations between the HRQoL measures and HS disease severity measures were assessed., Methods: We analysed the HRQoL and clinical severity of patients with HS ( N = 92) treated in 5 Finnish hospitals using HRQoL measurement tools most often used in dermatological clinics, as well as the generic 15D instrument (standardized and self-administered 15-dimensional measure of HRQoL). The disease severity was assessed using the Hurley stage, International Hidradenitis Suppurativa Severity Score System, and disease severity evaluation by the investigator., Results: The mean 15D score of HS patients was low and comparable with that of patients with cancers. No correlation was found between HS severity measures and 15D score, indicating that even mild HS has a high impact on HRQoL., Conclusions: Our findings strengthen the understanding about HS as a debilitating disease and even compared with non-dermatological conditions and highlight the need of comprehensive care of patients with HS., Competing Interests: Dr Huilaja has received educational grants from CSL Behring, Shire, Janssen-Cilag, Novartis, AbbVie, and LEO Pharma and honoraria from AbbVie, Takeda, Novartis, Sanofi Genzyme, and UCB Pharma for consulting and/or speaking and is an investigator for AbbVie. Dr. Tiina Lipitsä has received educational grants from AbbVie and is an investigator for AbbVie. Dr. Rauno Harvima has received educational grants from AbbVie. Dr. Armi Vihervaara has received educational grants from AbbVie, Janssen, Novartis, and Celgene. Dr. Rafael Pasternack has received educational grants from AbbVie, Janssen, LEO Pharma, Novartis, and Sanofi Genzyme and honoraria from AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Sanofi Genzyme, and UCB for consulting and/or speaking; participated in clinical studies sponsored by AbbVie, Novartis, Eli Lilly, and Regeneron; and is an investigator for Abb­Vie. Harri Sintonen is the developer of the 15D instrument and obtains royalties from its electronic versions. Martta Ranta and Mirkka Hirvonen are employees of AbbVie and may or may not own AbbVie shares. The sponsor of this study, AbbVie, participated in the study design, study research, collection, analysis and interpretation of data and writing, reviewing, and approval of this publication. All authors had access to the data and participated in the development, review, and approval and decision to submit this publication., (Copyright © 2021 by S. Karger AG, Basel.)

Background and Aims: Major trauma impairs health-related quality of life (HRQoL). The aim of this study was the Finnish translation and external validation of the Trauma Quality of Life (TQoL) questionnaire., Patients and Methods: The Finnish version of the TQoL questionnaire and the 15D, a generic HRQoL questionnaire, were sent by mail to 417 patients identified from the Helsinki Trauma Registry., Results: Altogether 222 patients (53.2%) returned the questionnaires. Participants' mean age was 49.9 ± 18.1 years and 68.8% were males. The mean 15D score was significantly lower than that of the age- and sex-standardized general Finnish population (0.817 vs. 0.918, p  < 0.001). The correlation between the Finnish translation and 15D scores was high (0.805). Factor analysis revealed that the Finnish TQoL questionnaire and the 15D have four common factors. Internal validation identified some differences between the Finnish and the original versions., Conclusions: The correlation between the Finnish TQoL questionnaire and the 15D was high. The factor structures of the original and Finnish versions of the TQoL questionnaire were not identical, which may be a consequence of cultural or patient population differences.Implications for rehabilitationTrauma causes a long-term decrease in health-related quality of life (HRQoL), and this impact should be assessed in rehabilitation.The Trauma-Specific Quality of Life (TQoL) questionnaire has many shared features with the generic HRQoL questionnaire, but it also contains features related to post-traumatic disorder syndrome.The TQoL questionnaire is a valid tool for monitoring HRQoL after trauma.

There is a need for a systematic approach to evaluate patients for potential face transplantation (FT). Ten patients with severe facial defects treated between 1995 and 2017 formed the study group. Data was collected from patient charts and clinical, radiological and laboratory examinations. Facial deficiencies were subdivided into four different categories: anatomical region (10 facial subunits), facial function, aesthetic defect (range 0-9-worst), and impact on health-related quality of life (HRQoL) (15D questionnaire, range 0-1). Immunological status and possible contraindications were also evaluated. Defect aetiology consisted of burns (4), ballistic injury (3), blunt injury (1), blast injury (1), and neurofibromatosis type I (1). All patients had central facial deficiencies and 6 patients had 8 to 10 injured facial subunits. All patients had at least partial loss of facial function. The mean aesthetic disfigurement score was 6.4. The median lowering of 15D score was -0.107. None were significantly sensitized although four patients had relative contraindications and one patient had an absolute contraindication for FT. Three patients with a severe overall facial deficiency were considered as potential FT candidates. We herein propose a comprehensive and systematic tool to evaluate potential candidates for FT. This approach includes assessment of 4 key categories: anatomical regions affected, facial function, aesthetics, and HRQoL.

Metastasectomy and/or local ablative therapy in metastatic colorectal cancer (mCRC) patients often provide long-term survival. Health-related quality of life (HRQoL) data in curatively treated mCRC are limited. In the RAXO-study that evaluated repeated resectability, a multi-cross-sectional HRQoL substudy with 15D, EQ-5D-3L, QLQ-C30, and QLQ-CR29 questionnaires was conducted. Mean values of patients in different treatment groups were compared with age- and gender-standardized general Finnish populations. The questionnaire completion rate was 444/477 patients (93%, 1751 questionnaires). Mean HRQoL was 0.89−0.91 with the 15D, 0.85−0.87 with the EQ-5D, 68−80 with the EQ-5D-VAS, and 68−79 for global health status during curative treatment phases, with improvements in the remission phase (disease-free >18 months). In the remission phase, mean EQ-5D and 15D scores were similar to the general population. HRQoL remained stable during first- to later-line treatments, when the aim was no longer cure, and declined notably when tumour-controlling therapy was no longer meaningful. The symptom burden affecting mCRC survivors’ well-being included insomnia, impotence, urinary frequency, and fatigue. Symptom burden was lower after treatment and slightly higher, though stable, through all phases of systemic therapy. HRQoL was high in curative treatment phases, further emphasizing the strategy of metastasectomy in mCRC when clinically meaningful.

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., (© 2021 John Wiley & Sons Ltd.)

Background: Air impurities can exacerbate or cause rhinologic diseases. However, only a few studies have assessed rhinologic patients' symptoms at work., Objective: This study surveys the impact of work on rhinology clinic patients' quality of life in relation to work-related respiratory exposures. In addition, we surveyed patients' sick leave periods., Methods: We recruited adult employed rhinology patients referred to the otorhinolaryngology clinic. A total of 177 patients were included. We collected data on patients' medical history, rhinologic disease-specific and generic quality of life, current or most recent job title, a description of current work, nasal symptoms, possible worked-related symptom triggers and sick leave periods during the preceding year., Results: In total, 101 (57.1%) patients reported exacerbated rhinologic symptoms at work and reported more severe rhinologic disease and a lower disease-specific quality of life compared to non-work-related rhinologic patients (P = 0.008). A minority, 24.3% of our patients were exposed to any specific occupational respiratory sensitizer or irritant at work. The mean sick leave period due to rhinologic disease was 7.7 days per year., Conclusions: Exposure to specific occupational sensitizers or irritants did not associate with increasing symptoms at work or quality of life amongst our patients. Most rhinology patients reported exacerbated symptoms at work. They appeared to be more symptomatic than the rest of the patients and, therefore, possibly hyperreactive to unspecific respiratory triggers at work. Rhinologic diseases caused our patients a marked burden with high work absenteeism.

Background: Health-related quality of life (HRQoL) impairment is often reported among COVID-19 ICU survivors, and little is known about their long-term outcomes. We evaluated the HRQoL trajectories between 3 months and 1 year after ICU discharge, the factors influencing these trajectories and the presence of clusters of HRQoL profiles in a population of COVID-19 patients who underwent invasive mechanical ventilation (IMV). Moreover, pathophysiological correlations of residual dyspnea were tested., Methods: We followed up 178 survivors from 16 Italian ICUs up to one year after ICU discharge. HRQoL was investigated through the 15D instrument. Available pulmonary function tests (PFTs) and chest CT scans at 1 year were also collected. A linear mixed-effects model was adopted to identify factors associated with different HRQoL trajectories and a two-step cluster analysis was performed to identify HRQoL clusters., Results: We found that HRQoL increased during the study period, especially for the significant increase of the physical dimensions, while the mental dimensions and dyspnea remained substantially unchanged. Four main 15D profiles were identified: full recovery (47.2%), bad recovery (5.1%) and two partial recovery clusters with mostly physical (9.6%) or mental (38.2%) dimensions affected. Gender, duration of IMV and number of comorbidities significantly influenced HRQoL trajectories. Persistent dyspnea was reported in 58.4% of patients, and weakly, but significantly, correlated with both DLCO and length of IMV., Conclusions: HRQoL impairment is frequent 1 year after ICU discharge, and the lowest recovery is found in the mental dimensions. Persistent dyspnea is often reported and weakly correlated with PFTs alterations., Trial Registration: NCT04411459., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Objective: To investigate long-term health-related quality of life (HRQoL) changes over time in younger compared to older disease-free breast cancer survivors who participated in a prospective randomized exercise trial., Methods: Survivors (aged 35-68 years) were randomized to a 12-month exercise trial after adjuvant treatment and followed up for ten years. HRQoL was assessed with the generic 15D instrument during follow-up and the younger (baseline age ≤ 50) and older (age >50) survivors' HRQoL was compared to that of the age-matched general female population (n = 892). The analysis included 342 survivors., Results: The decline of HRQoL compared to the population was steeper and recovery slower in the younger survivors (p for interaction < 0.001). The impairment was also larger among the younger survivors (p = 0.027) whose mean HRQoL deteriorated for three years after treatment and started to slowly improve thereafter but still remained below the population level after ten years (difference -0.017, 95% CI: -0.031 to -0.004). The older survivors' mean HRQoL gradually approached the population level during the first five years but also remained below it at ten years (difference -0.019, 95% CI: -0.031 to -0.007). The largest differences were on the dimensions of sleeping and sexual activity, on which both age groups remained below the population level throughout the follow-up., Conclusions: HRQoL developed differently in younger and older survivors both regarding the most affected dimensions of HRQoL and the timing of the changes during follow-up. HRQoL of both age groups remained below the population level even ten years after treatment., Competing Interests: Declaration of competing interest Harri Sintonen is the developer of the 15D., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Purpose: The onset of the coronavirus disease 19 (COVID-19) pandemic in Italy induced a dramatic increase in the need for intensive care unit (ICU) beds for a large proportion of patients affected by COVID-19-related acute respiratory distress syndrome (ARDS). The aim of the present study was to describe the health-related quality of life (HRQoL) at 90 days after ICU discharge in a cohort of COVID-19 patients undergoing invasive mechanical ventilation and to compare it with an age and sex-matched sample from the general Italian and Finnish populations. Moreover, the possible associations between clinical, demographic, social factors, and HRQoL were investigated., Methods: COVID-19 ARDS survivors from 16 participating ICUs were followed up until 90 days after ICU discharge and the HRQoL was evaluated with the 15D instrument. A parallel cohort of age and sex-matched Italian population from the same geographic areas was interviewed and a third group of matched Finnish population was extracted from the Finnish 2011 National Health survey. A linear regression analysis was performed to evaluate potential associations between the evaluated factors and HRQoL., Results: 205 patients answered to the questionnaire. HRQoL of the COVID-19 ARDS patients was significantly lower than the matched populations in both physical and mental dimensions. Age, sex, number of comorbidities, ARDS class, duration of invasive mechanical ventilation, and occupational status were found to be significant determinants of the 90 days HRQoL. Clinical severity at ICU admission was poorly correlated to HRQoL., Conclusion: COVID-19-related ARDS survivors at 90 days after ICU discharge present a significant reduction both on physical and psychological dimensions of HRQoL measured with the 15D instrument., Trial Registration: NCT04411459., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Background: Cardio-regenerative cell therapies offer additional biologic support to coronary artery bypass surgery (CABG) and are aimed at functionally repairing the myocardium that suffers from or is damaged by ischemia. This non-randomized open-label study assessed the safety and feasibility of epicardial transplantation of atrial appendage micrografts (AAMs) in patients undergoing CABG surgery. Methods: Twelve consecutive patients destined for CABG surgery were included in the study. Six patients received AAMs during their operation and six patients were CABG-operated without AAMs transplantation. Data from 30 elective CABG patients was collected for a center- and time-matched control group. The AAMs were processed during the operation from a biopsy collected from the right atrial appendage. They were delivered epicardially onto the infarct scar site identified in preoperative late gadolinium enhancement cardiac magnetic resonance imaging (CMRI). The primary outcome measures at the 6-month follow-up were (i) patient safety in terms of hemodynamic and cardiac function over time and (ii) feasibility of therapy administration in a clinical setting. Secondary outcome measures were left ventricular wall thickness, change in myocardial scar tissue volume, changes in left ventricular ejection fraction, plasma concentrations of N-terminal pro-B-type natriuretic peptide levels, NYHA class, number of days in hospital and changes in the quality of life. Results: Epicardial transplantation of AAMs was safe and feasible to be performed during CABG surgery. CMRI demonstrated an increase in viable cardiac tissue at the infarct site in patients receiving AAMs treatment. Conclusions and Relevance: Transplantation of AAMs shows good clinical applicability as performed during cardiac surgery, shows initial therapeutic effect on the myocardium and has the potential to serve as a delivery platform for cardiac gene therapies. Trial Registration: ClinicalTrials.gov, identifier: NCT02672163., Competing Interests: AN and EK are stakeholders in EpiHeart Ltd. developing medical devices for the operating room. HS is the developer of the 15D. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Nummi, Mulari, Stewart, Kivistö, Teittinen, Nieminen, Lampinen, Pätilä, Sintonen, Juvonen, Kupari, Suojaranta, Kankuri, Harjula, Vento and the AADC consortium.)

Purpose: The purpose of this study was to evaluate patients' health-related quality of life (HRQoL) before and after surgical treatment of orbital blow-out fracture., Methods: This prospective study comprises of all adult patients undergoing a surgical reconstruction of an orbital blow-out fracture in 2006-2010. Their HRQoL was evaluated for 6 months postoperatively with the aid of the standardized 15D instrument and was compared with that of an age- and gender-standardized sample of the general Finnish population. A complementary questionnaire for more detailed information was also administered., Results: Twenty-six patients completed the study. Mean 15D score among the patients preoperatively (0.898) was statistically significantly and clinically importantly worse than the score of the control population (0.936). Six months postoperatively, the mean 15D score was 0.920, with no significant difference compared with the control population and the significant differences on the different dimensions had disappeared. The most common complaint at 6 months postoperatively was diplopia in daily life (19%). Disturbances in facial sensation (27%) and defects in facial appearance (15%) were the most unpleasant subjective outcomes., Conclusion: The HRQoL is significantly decreased after orbital blow-out fracture compared with the general population but will recover completely in 6 months. Thus, the negative impact of orbital blow-out fracture on HRQoL is only transient. Disturbances in facial sensation, defects in facial appearance, and diplopia are the most common subjective complaints after the injury and its surgical treatment. However, these do not appear to affect the overall quality of life in the long term., (© 2020. The Author(s).)

Background: Due to lack of validated body contouring-specific patient-reported outcome (PRO) instruments, the outcomes of abdominoplasty after massive weight loss have been evaluated rather rarely and mainly using generic health-related quality of life (HRQoL) instruments. The aim of the current study was to examine, using body contouring-specific (BODY-Q) and generic (15D) HRQoL instruments, the HRQoL, and key factors related to HRQoL among patients having undergone massive weight loss and abdominoplasty., Methods: Altogether 52 patients who underwent abdominoplasty due to massive weight loss completed the BODY-Q and the 15D HRQoL instruments. The 15D scores were compared to those of age-, gender-, and BMI-adjusted control sample of the general population., Results: The mean score of the BODY-Q Abdomen scale was 50.7 out of 100 (SD 24.4). The HRQoL of abdominoplasty patients was lower than that of age-, gender-, and BMI-adjusted general population (p = 0.001). Sleeping, discomfort and symptoms, depression, excretion, and sexual activity were the patients' main concerns. Body image and psychological well-being were strongly associated with the perceived HRQoL. The satisfaction with appearance of the abdominal area was not associated with generic HRQoL., Conclusions: The HRQoL of abdominoplasty patients is lower than that of general population with similar age, gender and BMI. The most important factors associated with the HRQoL of the patients were body image, psychological well-being, and physical function., Competing Interests: Declaration of Competing Interests Harri Sintonen is the developer of the 15D and obtains royalties from its electronic versions. The other authors report no conflicts of interest., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: Patient-reported outcome (PRO) instruments measure health gains, including changes in health-related quality of life (HRQoL). Previous studies have assessed the reliability and relationship of multiple HRQoL instruments in search of the optimal instrument for feasible measurement of PROs. Although the 15D instrument was shown to have the best sensitivity and construct validity among cardiac patients, it is unknown how well it captures relevant disease-specific information scores compared to instruments included in the International Consortium for Health Outcomes Measurement (ICHOM) standard set. The aim of this study was to investigate whether the disease-specific PRO instruments and a generic HRQoL instrument capture disease related symptoms in coronary artery disease (CAD) patients., Methods: Health status and HRQoL were assessed with the instruments included in the ICHOM standard set: Seattle Angina Questionnaire short-form (SAQ-7), Rose Dyspnea Scale (RDS), two-item Patient Health Questionnaire (PHQ-2), and with the 15D HRQoL instrument at baseline and 1 year from the treatment in a university hospital setting. Spearman correlation and explanatory factor analysis were used to assess the relationship of baseline scores and 1-year change in scores of 297 patients., Results: At baseline, the overall 15D score and SAQ-physical limitation (SAQ-PL), 15D "breathing" and SAQ-PL, as well as "breathing" and RDS showed moderately strong correlations. The factor interpreted to reflect "Breathing-related physical activity", based on high loadings of "breathing", RDS, SAQ-PL, "mobility", "vitality", and "usual activities", explained 19.2% of the total variance. Correlations between 1-year changes in scores were fair. The factor of "Breathing-related physical activity", with significant loading of RDS, SAQ-PL, "breathing, "usual activities", "vitality", "sexual activity", "mobility", and disease-specific quality of life explained 20.5% of the total variance in 1-year change in scores. The correlation of angina frequency measured by SAQ-7 and the 15D instrument was poor., Conclusions: The 15D detects dyspnea and depression similarly to RDS and PHQ-2 but not angina similarly to the SAQ-7. This may call for supplementing the 15D instrument with a disease-specific instrument when studying CAD patients., (© 2021. The Author(s).)

Objectives: The impact of benign gynecological conditions on life of women and on costs for the society is high. The purpose of this study is to gain knowledge and understanding of costs of the treatment of these disorders in order to be able to improve the clinical care processes, gain insight into feasible savings opportunities and to allocate funds wisely., Methods: The healthcare processes of 311 women attending university or community hospitals in the Helsinki and Uusimaa Hospital District between June 2012 and August 2013 due to a benign gynecological condition were followed up for two years and treatment costs analysed., Results: Total direct hospital costs averaged 689€ at six months and 2194€ at two years. The most expensive treatment was that of uterine fibroids in the short term and that of endometriosis and fibroids later on. Costs did not depend on hospital size. Surgical operations caused nearly half of hospital costs. Productivity loss caused biggest expenses outside of the hospital. LNG-IUD (levonorgestrel-releasing intrauterine device) accounted for the largest pharmaceutical costs for patients. Hospital treatment was associated with a reduced need for outpatient services during follow-up., Conclusions: A majority of direct hospital costs arise over time. This stresses the need for prolonged healthcare management. To control costs, the need for repetitive doctors' appointments, monitoring tests, and ward treatments should be carefully evaluated. Procedures not needing an operation theatre (for example hysteroscopy for polypectomy), should be done ambulatorily., Competing Interests: None of the authors have any conflicts of interest regarding this study. Harri Sintonen is the developer of the 15D and receives royalties from its electronic versions. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Aims: To explore the effectiveness of a new perioperative practice model on anxiety and health-related quality of life in patients undergoing total hip arthroplasty and total knee arthroplasty under spinal anaesthesia., Design: A randomized clinical trial., Methods: Control group participants (N = 222) received standard perioperative care, meaning they were cared for by various nurses during their perioperative process without postoperative visits. Intervention group participants (N = 231) were assigned one named anaesthesia nurse during their entire perioperative process who visited them postoperatively. Both groups responded to two self-reported questionnaires: the generic 15D health-related quality of life instrument and the State-Trait Anxiety Inventory (STAI) measuring anxiety two to three weeks pre-operatively and three months postoperatively., Results: There were no statistically significant differences between the groups at baseline or at follow-up in health-related quality of life or anxiety., (© 2021 The Authors. Nursing Open published by John Wiley & Sons Ltd.)

Background: We wanted to understand how patients with different modified Rankin Scale (mRS) grades differ regarding their health-related quality of life (HRQoL) and how this affects the interpretation and dichotomization of the grade., Methods: In 2016, all adult patients in our brain arteriovenous malformation (AVM) database (n = 432) were asked to fill in mailed letters including a questionnaire about self-sufficiency and lifestyle and the 15D HRQoL questionnaire. The follow-up mRS was defined in 2016 using the electronic patient registry and the questionnaire data. The 15D profiles of each mRS grade were compared to those of the general population and to each other, using ANCOVA with age and sex standardization., Results: Patients in mRS 0 (mean 15D score = 0.954 ± 0.060) had significantly better HRQoL than the general population (mean = 0.927 ± 0.028), p < 0.0001, whereas patients in mRS 1-4 had worse HRQoL than the general population, p < 0.0001. Patients in mRS 1 (mean = 0.844 ± 0.100) and mRS 2 (mean = 0.838 ± 0.107) had a similar HRQoL. In the recently published AVM research, the most commonly used cut points for mRS dichotomization were between mRS 1 and 2 and between mRS 2 and 3., Conclusions: Using 15D, we were able to find significant differences in the HRQoL between mRS 0 and mRS 1 AVM patients, against the recent findings on stroke patients using EQ-5D in their analyses. Although the dichotomization cut point is commonly set between mRS 1 and 2, patients in these grades had a similar HRQoL and a decreased ability to continue their premorbid lifestyle, in contrast to patients in mRS 0.

Background: Seasonal variation in exacerbations, hospitalisations, and mortality statistics has been reported for some diseases. To our knowledge, however, no published studies exist on the seasonality of health-related quality of life (HRQoL) amongst rhinologic patients., Aims/objectives: This study, therefore, aimed to investigate the possible seasonal variation in rhinologic patients' HRQoL using the rhinologic disease-specific Sino-Nasal Outcome Test-22 (SNOT-22) and the generic 15D HRQoL instrument., Material and Methods: We enrolled unselected adult rhinologic patients requiring specialist care at the Helsinki University Hospital in this cross-sectional, questionnaire-based prospective study during four seasons: February (winter), May (spring), August (summer), and November (autumn). Patients received SNOT-22 and 15D questionnaires via post. The Finnish Meteorological Institute supplied climate data from these months., Results: SNOT-22 and 15D data were available for 301 and 298 patients, respectively. We found no statistically significant differences ( p = 0.948) between the mean monthly 15D scores or mean SNOT-22 scales. Furthermore, the mean SNOT-22 subscales did not differ between the monthly study periods., Conclusions and Significance: Our study shows that seasonality did not impact rhinologic patients' SNOT-22 or 15D HRQoL scores. Thus, these questionnaires can be used for follow-up amongst rhinologic patients regardless of season.

Aim: To assess health-related quality of life (HRQoL) of patients with benign gynecological disorders. Materials & methods: Prospective 2-year follow-up with the 15D HRQoL-instrument of 311 women treated in Helsinki-area hospitals in 2012-2013. Results: The initially impaired HRQoL regarding excretion, discomfort and symptoms, and vitality and sexual activity improved after treatment. However, only sexual activity reached similar levels as in the general population. Treatment of endometriosis, fibroids and polyps resulted in best and that of unspecific pelvic pain and bleeding disorders in worst HRQoL scores. Results were independent of hospital size. Conclusion: The impaired HRQoL dimensions were improved by treatment but HRQoL still remained poorer than in the general female population. Treatment of unspecific pelvic pain and bleeding disorders needs further evaluation.

Background: We aim to shed light on long-term subjective outcomes after re-operations for failed fundoplication., Methods: 1809 patients were operated on for hiatal hernia and/or gastroesophageal reflux disease (GERD) at the Helsinki University Hospital between 2000 and 2017. 111 (6%) of these had undergone a re-operation for a failed antireflux operation. Overall, HRQoL was assessed in 89 patients at the latest follow-up using the generic 15D© instrument. The results were compared to a sample of the general population, weighted to reflect the age and gender distribution of patients. Disease-specific HRQoL was assessed using the GERD-HRQoL questionnaire. We studied variation in the overall HRQoL with respect to disease-specific HRQoL and known patients' parameters using univariate and multivariable linear regression models., Results: The median postoperative follow-up period was 9.3 years. All patients were operated on laparoscopically (6% conversion rate), and 87% were satisfied with the re-operation. Postoperative complications were minimal (5%). Twelve patients (11%) underwent a second re-operation. The median GERD-HRQoL score was nine. In multivariable analysis, four variables were independently associated with the 15D score, suggesting a decrease in the 15D score with increasing GERD-HRQoL score, increasing Charlson Comorbidity Index (CCI) and the presence of chronic pain syndrome (CPS) and depression., Conclusion: Re-do LF is a safe procedure in experienced hands and may offer acceptable long-term alleviation in patients with recurring symptoms after antireflux surgery. Decreased HRQoL in the long run is related to recurring GERD and co-morbidities.

Background: Pulmonary diseases affect health-related quality of life (HRQoL), but there are few data on patients' adaptation to a serious illness. This study assessed resilience and its associations with HRQoL, life satisfaction, anxiety and depression in patients with pulmonary diseases receiving ambulatory oxygen therapy., Methods: In this prospective cohort study, we enrolled 42 patients with pulmonary diseases receiving ambulatory oxygen therapy. The patients completed the following questionnaires at baseline and after one and three months; the Resilience Scale-25, the Life Satisfaction Scale-4, the 15D instrument of HRQoL, the Hospital Anxiety and Depression Scale (HADS) and the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0). To compare HRQoL, we recruited age- and gender-matched controls from the general population (n = 3574). The primary outcome was the proportion of patients with low resilience., Results: Half (42-48%) of the patients had low resilience, which was correlated with low HRQoL, low levels of life satisfaction and higher levels of anxiety and depression. Patients had very low HRQoL compared to controls. Dissatisfaction with life increased during the 3-months follow-up, but only a few patients had anxiety or depression. Patient satisfaction with assistive technology was high; the median QUEST 2.0 score (scale 1-5) was 4.00 at baseline, 3.92 at one month and 3.88 at three months., Conclusions: Resilience was low in half of the patients with pulmonary diseases receiving ambulatory oxygen therapy. Higher resilience was positively correlated with HRQoL and life satisfaction and negatively correlated with anxiety and depression., Trial Registration: ClinicalTrials.gov Protocol Record 507A023. Registered 17 September 2020-Retrospectively registered, https://clinicaltrials.gov/ct2/results?cond=&term=NCT04554225&cntry=&state=&city=&dist= .

Background: The purpose of this study was to determine the mid-term clinical, radiographic and health-related quality of life (HRQoL) outcomes and define the survival rate in patients who had undergone revision total knee arthroplasty (TKA) using the single rotating hinged knee (RHK) design., Methods: Between January 2004 and December 2013, 125 revision TKAs were performed at our institution using the single RHK implant. We conducted both a retrospective analysis of prospectively collected outcome data of these patients and a prospective follow-up study of all 39 living patients (41 knees). The follow-up phase included an optional extra follow-up visit, PROM questionnaires, and plain radiographs., Results: The ten-year Kaplan-Meier survival rate of the revision RHK knees was 81.7% (95% CI 71.9-91.6%) with re-revision for any reason as the endpoint. Overall, 15 knees (12% of the total) underwent re-revision surgery during the follow-up. The median follow-up was 6.2 years (range, 0-12.7 years) post-operatively for the baseline group. One mechanical hinge mechanism-related failure occurred without any history of trauma or infection. At the time of the final follow-up, the majority of patients evinced a fairly good clinical outcome measured with patient-reported outcome measures and none of the components were radiographically loose., Conclusion: We found that in patients undergoing complex revision TKA, fairly good functional outcome and quality of life can be achieved using an RHK implant. Further, it seems that in this type of patient cohort, revision TKA using an RHK implant relieves pain more than it improves ability to function. The NexGen® RHK design can be regarded as a suitable option in complex revision TKA.

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., (© 2020 The Authors. Clinical Endocrinology published by John Wiley & Sons Ltd.)

Importance: Laparoscopic sleeve gastrectomy (LSG) is currently the predominant bariatric procedure, although long-term weight loss and quality-of-life (QoL) outcomes compared with laparoscopic Roux-en-Y gastric bypass (LRYGB) are lacking., Objective: To determine weight loss equivalence of LSG and LRYGB at 7 years in patients with morbid obesity, with special reference to long-term QoL., Design, Setting, and Participants: The SLEEVE vs byPASS (SLEEVEPASS) multicenter, multisurgeon, open-label, randomized clinical equivalence trial was conducted between March 10, 2008, and June 2, 2010, in Finland. The trial enrolled 240 patients with morbid obesity aged 18 to 60 years who were randomized to undergo either LSG or LRYGB with a 7-year follow-up (last follow-up, September 26, 2017). Analysis was conducted on an intention-to-treat basis. Statistical analysis was performed from June 4, 2018, to November 8, 2019., Interventions: Laparoscopic sleeve gastrectomy (n = 121) or LRYGB (n = 119)., Main Outcomes and Measures: The primary end point was percentage excess weight loss (%EWL) at 5 years. Secondary predefined follow-up time points were 7, 10, 15, and 20 years, with included 7-year secondary end points of QoL and morbidity. Disease-specific QoL (DSQoL; Moorehead-Ardelt Quality of Life questionnaire [range of scores, -3 to 3 points, where a higher score indicates better QoL]) and general health-related QoL (HRQoL; 15D questionnaire [0-1 scale for all 15 dimensions, with 1 indicating full health and 0 indicating death]) were measured preoperatively and at 1, 3, 5, and 7 years postoperatively concurrently with weight loss., Results: Of 240 patients (167 women [69.6%]; mean [SD] age, 48.4 [9.4] years; mean [SD] baseline body mass index, 45.9 [6.0]), 182 (75.8%) completed the 7-year follow-up. The mean %EWL was 47% (95% CI, 43%-50%) after LSG and 55% (95% CI, 52%-59%) after LRYGB (difference, 8.7 percentage units [95% CI, 3.5-13.9 percentage units]). The mean (SD) DSQoL total score at 7 years was 0.50 (1.14) after LSG and 0.49 (1.06) after LRYGB (P = .63), and the median HRQoL total score was 0.88 (interquartile range [IQR], 0.78-0.95) after LSG and 0.87 (IQR, 0.78-0.95) after LRYGB (P = .37). Greater weight loss was associated with better DSQoL (r = 0.26; P < .001). At 7 years, mean (SD) DSQoL scores improved significantly compared with baseline (LSG, 0.50 [1.14] vs 0.10 [0.94]; and LRYGB, 0.49 [1.06] vs 0.12 [1.12]; P < .001), unlike median HRQoL scores (LSG, 0.88 [IQR, 0.78-0.95] vs 0.87 [IQR, 0.78-0.90]; and LRYGB, 0.87 [IQR, 0.78-0.92] vs 0.85 [IQR, 0.77-0.91]; P = .07). The overall morbidity rate was 24.0% (29 of 121) for LSG and 28.6% (34 of 119) for LRYGB (P = .42)., Conclusions and Relevance: This study found that LSG and LRYGB were not equivalent in %EWL at 7 years. Laparoscopic Roux-en-Y gastric bypass resulted in greater weight loss than LSG, but the difference was not clinically relevant based on the prespecified equivalence margins. There was no difference in long-term QoL between the procedures. Bariatric surgery was associated with significant long-term DSQoL improvement, and greater weight loss was associated with better DSQoL., Trial Registration: ClinicalTrials.gov Identifier: NCT00793143.

Background: The prognosis of complex primary total knee arthroplasty (TKA) with severe deformity and ligament deficiency is not clear. There is a paucity of evidence in the current literature on treatment outcomes of the rotating hinge knee implants in primary TKA. The aim of this study was to determine the mid-term clinical, radiographic, and health-related quality of life (HRQoL) outcomes in patients who had undergone complex primary TKA using single hinged knee replacement., Methods: In total, 106 complex primary TKAs (101 patients) were performed using the single rotating hinged knee (RHK) implant design at our institution between January 2004 and December 2013. We conducted a retrospective analysis of prospectively collected outcome data of these patients, obtaining also information on all possible revision surgeries from the Finnish Arthroplasty Register, and conducted a prospective follow-up study of all living patients., Results: The 10-year Kaplan-Meier survival rate of the RHK knees was 91.6% (95% CI 86.0% to 97.2%) with revision for any reason as the endpoint. Overall, eight knees (7.5 %) underwent revision surgery during the follow-up. None of the unrevised RHK knees were radiographically loose. The majority of patients evinced good clinical outcome and quality of life as measured with patient reported outcome measures., Conclusion: The hinge knee replacement which was assessed current study can be regarded as a suitable option in complex primary TKA, provided adequate attention is paid to the correct indications and patient selection., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The author AE has received research support funding from DePuy Synthes and Zimmer Biomet and speaking/presentation fee from Zimmer Biomet., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Cardiovascular disease (CVD) and thyroid dysfunction are common in older people, but little is known about how they affect health-related quality of life (HRQoL)., Methods: We assessed HRQoL with the 15D instrument in 329 home-dwelling patients aged ≥ 75 years with stable CVD and compared the results to those of an age- and gender-matched general population (n = 103). We also studied the impact of age, BMI, number of medications, thyroid-stimulating hormone (TSH) concentration, levothyroxine (L-T4) substitution and Mini-Mental State Examination (MMSE) on HRQoL., Results: Overall HRQoL was impaired in older people with stable CVD (mean 15D score 0.777 vs 0.801, p = 0.001), and also on single dimensions of breathing, sleeping, discomfort and symptoms, distress, vitality (all p < 0.001), and depression (p = 0.016) compared to the age- and gender-matched general population. Furthermore, in the patients, L-T4 substitution associated with impaired sleeping (p = 0.018) and sexual activity (p = 0.030). Moreover, MMSE points, number of medications used, age (all p < 0.001) and BMI (p = 0.009) predicted impaired HRQoL., Conclusions: Older people with stable CVD are characterized by impaired HRQoL compared to age- and gender-matched controls. We demonstrate that this is the consequence of impaired breathing, sleeping, discomfort and symptoms, distress, vitality, and depression. L-T4 substitution has a negative impact on HRQoL in old patients with stable CVD. MMSE score, number of medications, age and BMI predict worse HRQoL.