Changes in health-related quality of life in common variable immunodeficiency: an eight-year journey, including the COVID-19 pandemic.

BACKGROUND: Personalized medicine requires the assessment of the impact of health care interventions on Health-Related Quality of Life. RESEARCH DESIGN AND METHODS: We run an observational study of HRQoL in 140 CVID patients with biannual assessments over 8 years using a disease-specific tool, the CVID_QoL, and the GHQ questionnaires. Factors influencing changes in HRQoL scores were identified using multiple linear regression models with a stepwise procedure. RESULTS: Infections frequency, female gender, and chronic enteropathy were associated with worse global CVID_QoL scores. The presence of permanent organ damage and older age contributed to the perception of being at risk of health deterioration, while chronic enteropathy was associated with fatigue. The presence of permanent organ damage was also associated with perceived difficulties in usual activities. The frequency of infections was the main risk factor for difficulties in long-term planning and perceptions of vulnerability. Before COVID-19, improved HRQoL scores were associated with reduced respiratory infections and changes in immunoglobulin replacement route and setting. The COVID-19 pandemic caused a sudden deterioration in all HRQoL dimensions, and a further deterioration in the emotional dimension was observed during the pandemic period. Patients who died during the study had worse CVID_QoL scores at all time points, confirming that HRQoL performance is strongly related to patient outcome. CONCLUSIONS: Periodic HRQoL assessments are needed to capture relevant issues that change over time in patients affected by long-term chronic conditions such CVID, possibly identifying areas of intervention.

Validation of the Lithuanian version of the Prolapse Quality-of-Life questionnaire.

INTRODUCTION AND HYPOTHESIS: We aimed to translate and validate the Lithuanian version of the Prolapse Quality-of-Life (P-QOL) questionnaire. METHODS: The P-QOL questionnaire was translated into Lithuanian and administered to women recruited from a gynaecology outpatient clinic at a tertiary referral centre. The scores of the final version were compared in symptomatic (n = 137) and asymptomatic (n = 137) women and with findings on vaginal examination using the Pelvic Organ Prolapse Quantification system. The reliability was assessed by calculating Cronbach's alpha and by performing a test-retest analysis. RESULTS: There was a significant difference in median score for each P-QOL domain between symptomatic and asymptomatic women (p < 0.001). P-QOL scores correlated significantly with the stage of urogenital prolapse in most domains. High internal consistency was shown in all domains with a Cronbach's alpha range of 0.775 to 0.958, except for the "social limitations" domain, which was shown to be acceptable (0.647). Test-retest reliability was also high in all domains (p < 0.05). CONCLUSION: The Lithuanian version of the P-QOL questionnaire has proven to be a valid, reliable and easily comprehensible instrument for assessing symptom severity and impact on the quality of life of Lithuanian-speaking women with urogenital prolapse.

Quality of life following a maternal near-miss event during the COVID-19 pandemic at a tertiary care center in South India.

OBJECTIVE: To assess the quality of life (QoL) in women following a maternal near-miss event and to assess the women's attitude towards future fertility and their contraceptive choices. METHODS: A cross-sectional observational study was conducted in Government Medical College, Kozhikode, India among women who had experienced a near-miss event (n = 50) between January 1, 2020 and May 31, 2021 during the peak of the COVID-19 pandemic. The QoL was assessed using the WHO Quality of Life, BREF Version, questionnaire, which was administered to the consenting participants over phone. Information regarding desire for future fertility, contraceptive choices, and urogenital symptoms was also collected. A comparison between the short-term and long-term effects on the QoL was also done. RESULTS: A maternal near-miss event was not found to adversely affect the overall quality of life in the present study. The scores in all the four domains-physical, psychological, social relationships, and environmental-suggested good QoL, although greater variability in values were observed in the physical and psychological domains. The influence in these two domains was more pronounced following a perinatal loss and following prolonged physical morbidities. There was no difference in short- and long-term QoL following a maternal near miss (MNM). The MNM did not influence the contraceptive choices and there was no subsequent pelvic floor dysfunction in most women. CONCLUSION: MNM was not found to adversely affect the overall subsequent QoL in the present study. There was no difference in short- and long-term QoL following a MNM. Studies carried out over a longer period of time with a control group would yield more information.

Effectiveness of a hysteroscopic tissue removal system device for hysteroscopic myomectomy on patients' quality of life: a randomized clinical trial.

PURPOSE: To evaluate the quality of life in patients treated for submucosal leiomyomas after hysteroscopic myomectomy compared to medical therapy. This is the first prospective randomized analysis comparing outcomes of medical therapy versus hysteroscopic myomectomy using the TruClear™ hysteroscopic tissue removal system to treat heavy menstrual bleeding from submucosal leiomyoma(s). METHODS: Setting: private practice and community-based hospital; subjects: female patients with symptomatic submucosal leiomyomas from 2014 to 2017. A total of 69 patients enrolled, with 47 completed. STATISTICAL ANALYSIS USED: randomization, linear mixed-effects modeling, hypothesis testing, and intent-to-treat analysis. Each patient was randomized to oral contraceptive pills/progesterone releasing intrauterine device or hysteroscopic myomectomy. Each patient was to complete the Uterine Fibroid Symptom and Health-related Quality of Life (UFS-QOL) questionnaire at baseline, one month, three months, and greater than or equal to six months after treatment. MAIN OUTCOME MEASURED: Primary outcome was the health-related quality of life (HR-QOL), as reflected from UFS-QOL scores. Contrasts were constructed from a linear mixed-effects model to compare the two treatment groups for changes from baseline in UFS-QOL scores. RESULTS: UFS-QOL scores were similar at baseline between the two treatment groups. There was an overall improvement in all UFS-QOL scores within each group. Higher improvement scores were noted in the surgical group compared to the medical group for almost all UFS-QOL scores. At ≥ 6 months, in comparison to the medically managed patients, the most considerable score improvements for the surgical group were reported in HR-QOL concern, activities, self-consciousness and symptom severity scores having mean change scores (95% CIs) of 35.3, 28.9, 28.6, and 32.2, respectively. CONCLUSION: Although there was no statistical difference in the change degree of improvement of overall quality of life among patients with symptomatic submucosal leiomyomas who received medical or surgical treatments in the study, there were greater differences in improvements in health-related quality of life scores over time after surgical treatment.

Spanish Version of the Anterior Cruciate Ligament-Quality of Life Questionnaire: Translation, Cross-cultural Adaptation, and Validation.

Background: The Anterior Cruciate Ligament-Quality of Life (ACL-QOL) questionnaire is a patient-reported outcome measure used to assess the effect of an anterior cruciate ligament (ACL) injury on the lives of patients. It was originally written in English, which may affect its use when completed by nonnative English speakers. Purpose: To translate and adapt the ACL-QOL to Spanish and provide evidence of its psychometric properties. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: A total of 183 patients with an ACL injury from 4 Catalan hospitals were included: 99 patients who had undergone ACL reconstruction (ACLR) completed the Spanish version of the ACL-QOL (ACL-QOL-Sp) twice (mean interval, 15.2 days) in 2 weeks for test-retest reliability, and 84 patients completed the ACL-QOL-Sp, the Lysholm knee scoring scale, the Knee injury and Osteoarthritis Outcome Score (KOOS), Tegner Activity Scale, and the 12-item Short Form Health Survey (SF-12) before and at 4 and 9 months after ACLR to assess responsiveness. The association between the ACL-QOL-Sp and the other outcome measures was evaluated with the Spearman correlation coefficient. Results: The ACL-QOL-Sp showed good internal consistency (Cronbach alpha = 0.96) and test-retest reliability (intraclass correlation coefficient = 0.97). The standard error of measurement was 3.6, also suggesting the precision of measurements. The smallest detectable change was 9.98 in 94% of patients. No association was found between the ACL-QOL-Sp score and the Tegner score or SF-12 mental component summary score; however, a moderate correlation was found with the overall KOOS score (r = -0.545), Lysholm score (r = 0.509), and SF-12 physical component summary score (r = 0.607). The correlation ranged from weak for the KOOS-Symptoms subscore (r = -0.290) to moderate for the KOOS-Quality of Life subscore (r = -0.698). No ceiling or floor effects were observed. The ACL-QOL-Sp showed a moderate effect size (0.73) at 4 months but a large effect size (1.70) at 9 months. Conclusion: The ACL-QOL-Sp showed adequate internal consistency, test-retest reliability, and responsiveness in evaluating quality of life after ACLR in Spanish-speaking patients.

[Spanish translation and cross-cultural adaptation of the Pressure Ulcer Quality of Life Questionnaire (PU-QOL).] / Traducción y adaptación transcultural al español del cuestionario de calidad de vida y úlceras por presión PU-QOL.

OBJECTIVE: Pressure ulcers (PU) are the most prevalent of the dependency-related injuries, affecting the quality of life of the patients who suffer them. However, there are no instruments adapted to the Spanish context to evaluate this quality of life. The use of specific tools in Spanish to evaluate the quality of life perceived by patients with PUs is considered an indispensable element for healthcare decisions. The aim of this paper was to translate and culturally adapt the Pressure Ulcer Quality of Life Questionnaire (PU-QOL) into Spanish for the measurement of health-related quality of life in patients with pressure ulcers. METHODS: A translation, back-translation, and pre-test method was used on the target population to obtain an adapted version of the original PU-QOL instrument. The area was Primary Care. The participants were fifteen Primary Care patients. Main steps: 1) Direct translation; 2) Synthesis and concordance of versions by an expert committee; 3) Back translation; 4) Consistency of the back translation with the author from the original questionnaire; and 5) Analysis of comprehensibility through cognitive interviews with a sample of patients. RESULTS: An instrument to measure perceived quality of life in patients with PU was obtained, composed of ten scales and eighty-three items. The scales and items of the original questionnaire were maintained. Conceptual and semantic analysis produced adjustments in wording, clarification and reformulations adapted to the Spanish context. CONCLUSIONS: We present this first phase of translation and cross-cultural adaptation of the PU-QOL questionnaire in Spanish, which could be a useful tool for decision-making on health care in patients with PUs.

OBJETIVO: Las úlceras por presión (UPP) son las lesiones más frecuentes de las relacionadas con la dependencia y tienen un gran impacto en la calidad de vida de quienes las sufren. Disponer de herramientas en español específicas para evaluar la calidad de vida percibida por los pacientes con UPP se considera un elemento indispensable para la toma de decisiones sobre los cuidados de salud. El objetivo de este estudio fue traducir al español y adaptar culturalmente el cuestionario Pressure Ulcer Quality of Life Questionnaire (PU-QOL) para la medición de la calidad de vida relacionada con la salud en pacientes con úlceras por presión. METODOS: Se utilizó un método de traducción, retrotraducción y pretest a la población diana para obtener una versión adaptada del instrumento original PU-QOL. El emplazamiento fue la Atención Primaria. Los participantes fueron quince pacientes de Atención Primaria. Mediciones principales: 1) Traducción directa; 2) Síntesis y conciliación de las versiones por un comité de expertos; 3) Traducción inversa; 4) Conciliación de la traducción inversa con la autora del cuestionario original; y 5) Análisis de la comprensibilidad mediante entrevistas cognitivas a una muestra de pacientes. RESULTADOS: Se obtuvo un instrumento de medición de calidad de vida percibida en pacientes con UPP, compuesto por diez escalas y ochenta y tres ítems. Se mantuvieron las escalas e ítems del cuestionario original. El análisis conceptual y semántico produjo ajustes de redacción, clarificación y reformulaciones adaptadas al contexto español. CONCLUSIONES: La disponibilidad de un cuestionario en español de medición de calidad de vida percibida, como es el PU-QOL, del que presentamos esta primera fase de traducción y adaptación transcultural, podrá ser un elemento útil para la toma de decisiones sobre los cuidados en salud en pacientes con UPP.

Health-related quality of life in children after surgical repair of esophageal atresia: a cross-sectional study in China.

Objective: To investigate health-related quality of life (HRQOL) in patients after surgical repair for esophageal atresia (EA) and identify its potential influencing factors. Methods: A total of 102 EA children who had previously visited our hospital participated in this cross-sectional study. Basic data and disease data of the patients were collected. The HRQOL was measured with the Pediatric Quality of Life Inventory™4.0 (PedsQL™4.0) and EA-QOL questionnaire and ranked on a reverse 0-100 scale, with a higher number indicative of a better HRQOL perception. The scores of PedsQL™4.0 in children with EA were collected and compared with that of the demographically matched healthy control group. Meanwhile, the condition-specific HRQOL of EA was analyzed by the EA-QOL questionnaire, and the potential clinical factors that influenced the HRQOL were determined by the generalized linear model. Results: The group of EA and control reached a similar score in the generic PedsQL™4.0 (EA group: 86.55 ± 9.69; control group: 89.41 ± 6.54; p = 0.670). There was no significant difference between the EA group and the control group in other domains except the school functioning. Condition-specific HRQOL in the 2-7-year-old group had the highest score in social isolation and stress domain and the lowest score in the physical health and treatment domain, with an overall quality of life score of 83.48 ± 10.22. The scores of the 8-17-year-old group were relatively high in social relationships and health and well-being and lowest in the eating domain, with an overall quality of life score of 89.43 ± 8.57. Heart malformation, complicated esophageal surgery history, respiratory symptoms,and digestive symptoms in the past 1 month were the main factors affecting the HRQOL of children aged 2-7 years. Complicated esophageal surgery history, respiratory symptoms, and digestive symptoms in the past 1 month were the main factors affecting the HRQOL of children aged 8-17 years. Conclusions: The findings suggest that patients with EA generally had a good HRQOL. However, EA children with postoperative complications and associated symptoms have lower scores in the EA-QOL questionnaire.

Short- and long-term evaluation of disease-specific symptoms and quality of life following uterine artery embolization of fibroids.

BACKGROUND: The purpose of this study is to evaluate uterine artery embolization (UAE) for the management of symptomatic uterine leiomyomas regarding changes in quality of life after treatment in a large patient collective. This study retrospectively analyzed prospectively acquired standardized questionnaires of patients treated with UAE. Clinical success was evaluated before and after embolization. Patients were stratified into short- (≤ 7 months) and long-term (> 7 months) follow-up groups depending on the time of completion of the post-interventional questionnaire. Uterine leiomyomas were furthermore divided into small (< 10 cm) and large (≥ 10 cm) tumors based on the diameter of the dominant fibroid. RESULTS: A total of 245 patients were included into the final data analysis. The Kaplan-Meier analysis showed a cumulative clinical success rate of 75.8% after 70 months until the end of follow-up (9.9 years). All questionnaire subscales showed a highly significant clinical improvement from baseline to short- and long-term follow-up (p < 0.001). Patients with small fibroids showed a significantly better response to UAE in multiple subcategories of the questionnaire than patients with fibroids ≥ 10 cm who had a twofold higher probability of re-intervention in the Cox-regression model. CONCLUSIONS: UAE is an effective treatment method for symptomatic fibroids that leads to quick relief of fibroid-related symptoms with marked improvement of quality of life and is associated with a low risk for re-interventions. Patients with small fibroids tend to show a better response to UAE compared to patients with large fibroids. Trial registration Charité institutional review board, EA4/167/20. Registered 27 November 2020-Retrospectively registered. https://ethikkommission.charite.de/.

Development and psychometric properties of the human papillomavirus-quality of life (HPV-QoL) questionnaire to assess the impact of HPV on women health-related-quality-of-life.

PURPOSE: The HPV-Quality-of-Life (HPV-QoL) questionnaire was developed to determine the impact of Human-Papillomavirus (HPV) infection and related interventions on women health-related quality-of-life. This study provides the development and preliminary psychometric properties of a novel HPV-QoL questionnaire for adult women with HPV. METHODS: After reviewing literature and cognitive debriefing interviews in women who had experienced HPV-related conditions, instrument items and domains were developed. A draft questionnaire was pilot tested for comprehension and ease of completion. Psychometric evaluation of the final HPV-QoL scale was conducted in a psychometric study including 252 adult women derived to our centre by a positive HPV test in the cervical cancer screening program and/or presenting genital warts. RESULTS: The present study reveals that the HPV-QoL questionnaire, structured in four domains: general well-being [including psychological well-being and social well-being subdomains], health, contagiousness and sexuality, showed good metric properties of feasibility irrespective of age or educational level, and time to administer was less than 5 min. Internal consistency and temporal stability (reliability) showed values above the acceptable standards. The instrument showed its concurrent validity by means of a significant correlation with mental and sexual existing instruments; GHQ-12 and FSFI questionnaires, respectively, and also known groups validity showing significant differences among the subgroups regarding either sexual dysfunction or mental deterioration. CONCLUSION: This study provides an HPV-QoL questionnaire with an innovative patient-reported outcomes specific measurement tool to assess HRQoL in women with HPV infection. The present study suggests this questionnaire has satisfactory psychometric properties, including validity and reliability. Results support the use of the HPV-QoL questionnaire as a HRQoL measurement instrument for daily medical practice and clinical research.

The safety and efficacy of peroral endoscopic cardial constriction in gastroesophageal reflux disease.

BACKGROUND AND AIM: Gastroesophageal reflux disease (GERD) is one of the most common digestive disorders, which seriously affects the quality of life and brings a heavy burden to the medical care. Peroral endoscopic cardial constriction (PECC) can narrow the cardia through mucosal ligation to alleviate acid reflux symptoms. This study aims to assess the clinical efficacy of PECC. METHODS: This was a retrospective case series including patients diagnosed with GERD and undergoing PECC from September 2019 to July 2021. GERD-Q questionnaire and GERD-QOL questionnaire were applied to evaluate the symptom severity and the impact of life because of GERD. RESULTS: A total of 16 patients were included in our study. The mean GERD-Q score was 10.94 ± 2.11 before PECC, while 5.38 ± 3.90 after PECC. The mean GERD-QOL score was 43.60 ± 16.94 before PECC, while 73.65 ± 22.08 after PECC. 62.5% of patients were satisfied with the symptom control and no serious complications were reported in our study. CONCLUSIONS: PECC is an efficient and safe minimally invasive endoscopic intervention for GERD. It can significantly improve GERD-related symptoms and quality of life.

Psychometric properties of Persian version of wound-QOL questionnaire among older adults suffering from chronic wounds.

Background: Patients with chronic wounds experience various biopsychosocial problems which severely affects their quality of life (QoL). Thus, a Persian instrument to assess the QoL of these patients is required. This study aimed to determine the psychometric properties of the Persian version of the wound-QOL questionnaire. Methods: This methodological study was performed on Iranian patients during 2021-2022. The translation was carried out via forward-backward method. Face validity was addressed with 10 patients and content validity with 12 wound specialists. Construct validity was also assessed by performing exploratory factor analysis (EFA) (n = 100) and convergent validation with EQ-5D-3L plus Pain VAS Score and known-groups validity. The reliability was assessed by internal consistency using Cronbach's alpha coefficient and test-retest. Results: A total of 100 patients with chronic wounds were included in the study. Two factors with cumulative variance of 65.39% were extracted during EFA. The results revealed a significant and high correlation between the total scores of wound-QOL questionnaire, the Persian version of EQ-5D-3L (p = 0.000, r = 0.502), and Pain score (0-10; p = 0.000, r = 0.627). The Cronbach's alpha was 0.743 and stability of the questionnaire (α = 0.872) was confirmed. In confirming the known-groups validity, the results showed that this tool can differentiate the QOL of patients with different wounds. Conclusion: The Persian version of the wound-QOL questionnaire is a valid and reliable questionnaire which can measure the QoL of patients with chronic wounds. This instrument can be used in clinical evaluation as well as research purposes across the Iranian population.

Cross-cultural adaptation and validation of the 22-item sinonasal outcome test (SNOT-22) in German-speaking patients: a prospective, multicenter cohort study.

PURPOSE: Chronic rhinosinusitis (CRS) is a common condition associated with a significant reduction of the health-related quality of life. One of the most widely used assessment tools in CRS is the disease-specific, health-related questionnaire SNOT-22. The aim of this study was to translate and validate the SNOT-22 into the German language. METHODS: The questionnaire was translated using the forward-backward translation technique. After the translation its reliability, validity, and sensitivity were evaluated. For this purpose, the questionnaire was completed by patients diagnosed with CRS before, 3 months and 1 year after endoscopic sinus surgery and by healthy individuals as controls at three university hospitals in Germany. The individual scores of the questionnaire before surgery was correlated with the Lund-Mackay score as well as a global disease-specific question. RESULTS: A total of 139 CRS patients and 31 healthy individuals participated in the study. Internal consistency at all timepoints was very good, with Cronbach's alpha scores of 0.897, 0.941, and 0.945. The questionnaire was able to discriminate between CRS patients and control subjects (p < 0.0001) and scores improved significantly 3 month and 1 year after sinus surgery (p < 0.0001), indicating a good test-retest reliability, validity, and responsiveness. A significant correlation to the single global disease-specific question could be found (p < 0.0001), but no correlation with the Lund-Mackay score. CONCLUSION: The German Version of the SNOT-22 is a reliable, valid, and sensitive instrument for measuring health-related quality of life in patients with CRS. It can be recommended for clinical practice and outcome research for German-speaking patients.

Quality of life improvement in patients with hard-to-heal leg wounds treated with Prontosan wound irrigation solution and wound gel.

OBJECTIVE: This study evaluated the impact of four weeks of treatment with Prontosan Wound Irrigation Solution and Prontosan Wound Gel (B. Braun Medical Inc., US) on adults with hard-to-heal leg wounds. Overall change (weeks 1-5) in the Global Quality of Life scale (GQOL), changes in body, psyche and everyday life (EDL) quality of life (QoL) subscores, and changes in wound appearance and size after treatment were assessed. METHOD: In this prospective, open-label, single-arm, five-centre study, non-hospitalised patients with no more than two wounds below the knee were recruited into the study; wounds were ≥5cm2 and ≤50cm2 and present for ≥4 weeks. The investigator or a designee applied the wound solution and gel to the wounds at clinic visits, and patients/caregivers applied the wound solution and gel at home. Wound-QoL questionnaires were completed at the initial screening and at each week of treatment. Wound size and photographs were obtained at pre- and post-treatment during clinic visits. RESULTS: A total of 43 patients were enrolled in the study. Mean GQOL scores decreased by 1.11 (46.1%). Body, psyche and EDL decreased by 1.17 (60.0%), 1.26 (41.8%) and 1.00 (42.2%), respectively. Wounds also showed improvement in odour, appearance and size. Adverse events were mild in intensity and transient in nature. CONCLUSION: This study demonstrated marked improvement in the QoL of patients with hard-to-heal leg wounds below the knee during four weeks of treatment with the wound solution and gel. Wounds also showed improvement in odour, appearance and size, and the treatment solution and gel were well tolerated. DECLARATION OF INTEREST: B. Braun Medical Inc. funded the research and preparation of this article. AK, DV, CRC and WC are employees of B. Braun Medical Inc. AO and RS declare no conflict of interest.

Development and evaluation of air pollution-linked quality of life (AP-QOL) questionnaire: insight from two different cohorts.

In this study, the air pollution-related quality of life (AP-QOL) questionnaire was carried out in two geographically and economically different groups including New Delhi (Megacity) and Hamirpur, Himachal Pradesh (town), and APE scores were linked with respiratory and cardiovascular illness. The APE-Score was developed by AP-QOL questionnaire responses using Delphi technique and further analyzed using principal component analysis (PCA). For reliability of APE-Score and AP-QOL questionnaire, α-Cronbach's test and basic statistics were performed. The linear mixed-effect model and odds ratios were used to evaluate air pollution exposure and health outcomes. Overall, 720 academicians and 276 security guards were invited to participate in the questionnaire. Cronbach's α coefficients ranged from 0.70 to 0.84 indicated significant reliability in the AP-QOL questionnaire conducted in this study. Substantial variation in respiratory symptoms and their medical history were found - 76.9% ([95% confidential interval (CI)]: (- 83.8, - 66.9) (p < 0.05)) and - 28.6% (95% CI: (- 37.8, - 18.0) (p < 0.05)), respectively, with interquartile range (IQR) increase of APE score. The odds ratios (ORs) of respiratory medical history (MH Res.) showed a significant increase from 1.01 to 1.35 for low to high air pollution exposure in the academic group of IIT Delhi. Interestingly, for an academic group of NITH, the ORs for medical history of cardiovascular (MH Card.) showed an increase from 1.08 to 1.13 for low to high APE which was not the case for IIT Delhi academicians.

Efficacy of high intensity focused ultrasound treatment for cystic adenomyosis: a report of four cases.

BACKGROUND: Cystic adenomyosis is a particular type of adenomyosis, High intensity focused ultrasound (HIFU), as a non-invasive method, has also been used to treat adenomyosis. The purpose of this study was to investigate the efficacy, safety, and feasibility of HIFU for the treatment of cystic adenomyosis. METHODS: Diagnosis of cystic adenomyosis was obtained through trans-vaginal ultrasound and magnetic resonance imaging (MRI). Ultrasound-guided HIFU ablation was performed under conscious sedation. The patients were evaluated by the comparison of pre-HIFU and post-HIFU imaging, as well as the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire subscales, consisting of Symptom Severity Score (SSS) and Heath Related Quality of Life (HRQL). RESULTS: HIFU was effective in treating cystic adenomyosis. No complications were observed in the four patients who were successfully treated with HIFU. Compared to preoperative symptoms and patient satisfaction, symptoms at the first follow-up observed significant improvements, with no dysmenorrhea and high health-related quality of life. During the outpatient follow-up of one month, three months, and six months postoperation, the four patients were still without dysmenorrhea and were highly satisfied with the HIFU ablation. CONCLUSIONS: HIFU, as a non-invasive treatment, supplies a safe and effective possibility for the treatment of cystic adenomyosis.

A translation and preliminary validation of the Dutch Wound-QoL questionnaire.

BACKGROUND: Chronic wounds have a major impact on patients' health-related quality of life (HRQoL). Therefore, measuring HRQoL is an indispensable part of the treatment of patients with chronic wounds. The aim of this study was to translate and validate the Wound-QoL, a wound-specific HRQoL questionnaire, in a Dutch population. METHODS: The Wound-QoL was translated into Dutch according to the international standards. Patients with chronic wounds were asked to complete questionnaires at baseline (T0) and after six weeks (T1), including Wound-QoL, EQ-5D-3L (a generic questionnaire to measure HRQoL) and a visual analogue scale (VAS) measuring wound pain. If patients were not able to complete the questionnaire by themselves, it was read out to them by a nurse. Further data were obtained from medical records. RESULTS: Of the 120 patients included, 64 (53.3%) completed the questionnaire by themselves. To 55 patients (45.8%), the questionnaire was read out. The internal consistency of the Wound-QoL global score was high at both time points (T0: Cronbach's α = 0.89, T1: Cronbach's α = 0.92). The item selectivity for global score ranged from r = 0.25 to r = 0.77 at T0 and from r = 0.40 to r = 0.79 at T1. Overall, the self-completion and read-out subgroups showed similar internal consistency and item selectivity scores. With regard to convergent validity, significant correlations were found between Wound-QoL and EQ-5D-3L (T0: r = - 0.45, p < 0.001, T1: r = - 0.50, p < 0.001) as well as between Wound-QoL and pain VAS (T0: r = 0.23, p = 0.012, T1: r = 0.37, p = 0.001) at both time points. Responsiveness analyses showed significant correlations between changes in Wound-QoL and changes in EQ-5D-3L (r = - 0.37, p < 0.001), pain VAS (r = 0.24, p = 0.044) and wound size (r = 0.24, p = 0.013). The self-completion and read-out subgroups showed differences in convergent validity and responsiveness. CONCLUSIONS: The results indicate that the Dutch version of the Wound-QoL has positive psychometric properties. However, more research is needed to further explore the differences between self-completed and read-out questionnaires.

Quality of life improvements by durable pulmonary vein isolation in patients with atrial fibrillation.

INTRODUCTION: Successful pulmonary vein isolation (PVI) can improve the quality of life (QOL) of patients with atrial fibrillation (AF). However, the role of durable PVI for such QOL improvement is not known. The aim of this study was to clarify the effectiveness of durable PVI in improving the QOL of patients with AF. METHODS AND RESULTS: We assessed 119 patients who underwent PVI (age 66.4 ± 9.6 years, 104 paroxysmal AF). A scheduled electrophysiological study was performed 6 months after the first PVI session-regardless of recurrence of AF-to assess the durability of PVI and to identify and re-isolate reconnected pulmonary veins. QOL scores were evaluated by an AF-specific QOL questionnaire and checked at baseline, 6 months, and 1 year after the first session. In patients without AF recurrence (nonrecurrence group, n = 93), the scores at 6 months improved compared with those at baseline; conversely, the scores did not improve in patients with AF recurrence (n = 26). Nevertheless, the scores at 1 year improved compared with those at 6 months in both groups. Within the nonrecurrence group, the score difference between 6 months and baseline was higher in the durable PVI group (n = 58) than that in the nondurable PVI group (n = 35). CONCLUSIONS: The QOL of AF patients improved by the resumption of sinus rhythm following PVI. Patients with durable PVI had increased QOL scores compared with those with nondurable PVI. The durability of PVI may achieve further improvements in the QOL of patients with AF.

A quality of life questionnaire for patients with scapula alata (SA-Q): development and validation.

BACKGROUND: No quality of life (QoL) questionnaire exists for patients with scapula alata (SA). The objective of this study was to develop and validate a QoL questionnaire for SA patients. METHODS: A team consisting of experts (n = 7) and SA patients (n = 7) developed, through five continuous phases, a QoL questionnaire for SA patients (SA-Q). The developed questionnaire consists of 21 items, grouped in five domains: physical symptoms (five items), work (four items), sport and leisure activities (four items), life style (four items) and emotions (four items). Content and face validity for the SA-Q questionnaire were evaluated by a sample of 48 (90%) out of 53 SA patients recruited from a university hospital. The Content Validity Index (CVI) and modified kappa index (κ*) assessed the relevance of SA-Q questionnaire. RESULTS: The SA patients evaluated 20 (95%) out of 21 items as excellent for content validity (I-CVI > 0.78, κ* > 0.74), one (5%) item was considered as good (I-CVI < 0.78, 0.60 < κ* < 0.74). The average scale (S-CVI/ave) for the entire SA-Q questionnaire was 0.93 indicating an excellent content validity. CONCLUSIONS: This study presents the development and validation of content validity of the first QoL questionnaire for SA patients. The SA-Q questionnaire has potential clinical implications for detected changes concerning the different items during rehabilitation. CLINICAL TRIALS: Not relevant.

Quality of life after refractive surgery: ReLEx SMILE vs Femto-LASIK.

PURPOSE: The safety and effectiveness of complex myopic astigmatism correction using ReLEx SMILE or Femto-LASIK techniques have been well established. The purpose of the current study is to compare quality of life (QoL) outcomes following ReLEx SMILE or Femto-LASIK procedures in parallel with functional vision and anatomic outcomes of treated eyes. PATIENTS AND METHODS: This prospective, consecutive series included 118 patients, 18-43 years of age, out of which 56 underwent ReLEx SMILE and 62 underwent Femto-LASIK surgery for correction of myopic astigmatism. All patients underwent standard comprehensive ophthalmic examinations, and additionally, completed The Quality of Life Impact of Refractive Correction Questionnaire to determine the impact the vision-correction treatment had on their QoL. RESULTS: In both treatment groups, the postoperative refractive outcomes were comparable, with visual acuity improvements for both groups noted the day following surgery. After laser correction of complex myopic astigmatism using Femto-LASIK and ReLEx SMILE methods, the overall QoL indicators are statistically significant (P<0.01) exceeding preoperative values 1 month after the operation and reaching the maximum values by the end of the observation period (P<0.0001). CONCLUSION: The results of the study suggest that patients require some time to adapt to their new visual function and its impact on their daily living, delaying detectable improvements in QoL. Moreover, these results may suggest a higher satisfaction trend and long-term QoL in patients undergoing ReLEx SMILE in comparison to Femto-LASIK. Long-term results from the study demonstrated high patient satisfaction with both methods.

Linguistic Validation of the Phenylketonuria - Quality of Life (PKU-QOL) Questionnaire Into Brazilian Portuguese

Abstract The phenylketonuria - quality of life (PKU-QOL) questionnaire was developed to assess the impact of phenylketonuria (PKU) and its treatment on the health-related quality of life (HRQL) of patients and their caregivers. Available in four versions (child, adolescent, adult and parent), it was developed and validated in eight countries. The objective of this study was to linguistically validate the PKU-QOL questionnaire in Brazilian Portuguese for use in Brazil by clinicians who take care of PKU patients. The translation method used a standard linguistic validation process. The British English version served as a basis for translation. No major cultural or semantic issues were found during the process. The main difficulty was the use of the acronym "PKU" in the first translations. During the cognitive interviews, respondents made the confusion between the disease itself and the food supplement since it is written "PKU" or "COMIDA-PKU" on the packaging of the product. To overcome this issue, it was decided to use fenilcetonuria (fenil) or fenil alone throughout all versions. The PKU-QOL will be valuable for Brazilian healthcare providers in individualizing treatment and managing patients with PKU.