SF-36 Domains Research Articles

Patient-reported outcome measures for transthyretin cardiac amyloidosis: the ITALY study

Background Transthyretin cardiac amyloidosis (ATTR-CA) has a deep impact on the quality of life (QoL), yet no specific patient-reported outcome measures (PROMs) for ATTR-CA exist. Methods The ITALY study involved 5 Italian referral centres (Pisa, Pavia, Ferrara, Florence, Messina) enrolling consecutive outpatients with ATTR-CA. Results Two 30-item questionnaires were created for wild-type (wt) and variant (v) ATTR-CA. Scores ranged from 100 (best condition) to 0 (worst condition). Out of 140 patients enrolled (77% with ATTRwt-CA), 115 repeated the re-evaluation at 6 months. At baseline, only 30% of patients needed help to fill out the questionnaires. Among baseline variables, all KCCQ and SF-36 domains were univariate predictors of ITALY scores in ATTRwt-CA patients, with the KCCQ Symptom Summary score (beta coefficient 0.759), Social Limitations (0.781), and Overall summary score (0.786) being the strongest predictors. The SF-36 Emotional well-being score (0.608), the KCCQ Overall summary score (0.656), and the SF-36 Energy/fatigue score (0.669) were the strongest univariate predictors of ITALY scores in ATTRv-CA. Similar results were found at 6 months. Conclusions The ITALY questionnaires are the first specific PROMs for ATTRwt- and ATTRv-CA. Questionnaire completion is feasible. ITALY scores display close relationships with non-ATTR-specific measures of QoL.

Quality of life in individuals with knee osteoarthritis versus asymptomatic individuals.

Osteoarthritis (OA) is characterised by joint degeneration and represents the leading cause of disability in old age. OA entails a personal burden, with suffering and reduced quality of life (QoL). To compare the QoL of individuals with OA to that of asymptomatic individuals in order to determine the actual impact of OA on the affected population. Cross-sectional study with a sample of 140 patients diagnosed with OA. Another 51 sex- and age-matched asymptomatic individuals with no clinical signs of knee OA or lower limb osteoarticular symptoms for at least the preceding six months were recruited. Knee OA was stratified radiologically according to the Ahlbäck classification (1968). QoL was measured using the SF-36 questionnaire (Medical Outcomes Study 36-Item Short-Form Health Survey). The participants were assigned to "osteoarthritis" (OG) or "asymptomatic" (AG) groups. The OG presented greater body mass and BMI than the AG. Perceived QoL was worse for the OG than the AG across SF-36 domains. In the comparison of the grades of OA degeneration, the group with Ahlbäck grades 4 and 5 (severe) perceived their QoL as poorer than those with grades 1, 2, and 3 (moderate). The grade of OA, older age, and BMI were shown to be strong independent predictors of poor perceived quality of life. Individuals with knee OA showed worse perceived QoL compared with asymptomatic individuals. The domains with the lowest scores were physical functioning and functional limitation. Quality of life was influenced by BMI, age, sex, and grade of osteoarthritis.

CLINICAL PROFILE AND TREATMENT RESPONSE TO SOFOSBUVIR-VELPATASVIR REGIMEN AND ITS IMPACT ON THE QUALITY OF LIFE IN CHRONIC HEPATITIS C PATIENTS

Objective: Chronic Hepatitis C infection is one of the major global contributors to liver-related morbidity and mortality. Successful antiviral therapy with the direct-acting antiviral combination sofosbuvir-velpatasvir has shown to improve survival, liver-related outcomes, all-cause mortality, and even reverse fibrosis. We evaluated the treatment response of this regimen in terms of its impact on the Quality of life of patients during and after the therapy. Methods: This is an Observational, prospective, descriptive study of serologic HCV RNA-positive cases. Data on change in clinical, biochemical profile, and quality of life using 2 standardized questionnaires SF-36 and CLDQ was analyzed at baseline, 12 w from baseline, and 24 w after therapy cessation. Results: 62 out of the 87 patients registered during the study completed the desired study duration. 95% achieved sustained virological response (SVR) at 12 w and 100% at 24 w from baseline. Improved clinical profile with symptom resolution and change in the biochemical parameters and quality-of-life scores was statistically significant (P value-<0.001 and 0.005) at 12 w from baseline and 24 w after therapy cessation, respectively. Conclusion: Patients achieving SVR with sofosbuvir-velpatasvir have been shown to improve clinical profile with normalization in biochemical markers of liver disease, which is reflected in all the quality-of-life domains of SF-36 and CLDQ-HCV. However, long-term follow-up with larger sample size is required for improved study validity and to improve long-term liver-related outcomes.

Individualized Homeopathic Medicines in the Treatment of Painful Diabetic Peripheral Neuropathy: A Single-Arm, Pre–Post Comparison Trial

AbstractPainful peripheral neuropathy is one of the most common microvascular complications of long-continued, uncontrolled diabetes mellitus. The role of individualized homeopathic treatment has not been well evaluated in managing such cases earlier. This aim of this study was to assess the impact of individualized homeopathic treatment on pain intensity in patients with painful diabetic peripheral neuropathy (PDN) through an open-label, single-arm, pre–post comparison clinical trial. A total of 39 patients diagnosed with PDN were included in the trial. The visual analog scale (VAS) for pain and the 36-Item Short Form Survey (SF-36) were utilized as outcome measures and administered at baseline and after 3 months of intervention. Homeopathic medicines were prescribed using a precision-guided approach based on individualized principles. The changes in VAS score and SF-36 domains were analyzed using the Wilcoxon matched pairs signed rank test. Statistically significant reduction in neuropathic pain (median: 8.0; interquartile range [IQR]: 7.0–9.0) compared with baseline (median: 6.0; IQR: 5.0–7.0) were observed (Z = −5.34; p < 0.001). Moreover, improvements were seen in various SF-36 domains related to physical and emotional well-being, social functioning, pain, general health, and health change after 3 months of treatment. The frequently prescribed medicines included Lycopodium clavatum (15.4%), Natrum muriaticum (15.4%), Causticum (15.4%), Medorrhinum (12.8%), and Sulphur (12.8%). Individualized homeopathic treatment significantly reduced pain and enhanced the quality of life in individuals suffering from PDN. However, further randomized trials with improved methodological rigor are needed to strengthen the conclusions drawn from this study. Trial Registration CTRI/2018/10/016196; UTN: U1111–1221–7664.

Adverse effects of frailty on the outcomes of surgery for degenerative cervical myelopathy: results from a prospective multicenter international data set of 757 patients.

The goal of this study was to determine the effect of the degree of frailty on long-term neurological and functional outcomes after surgery for degenerative cervical myelopathy (DCM). A combined database of patients enrolled in the Cervical Spondylotic Myelopathy-North America and Cervical Spondylotic Myelopathy-International prospective international multicenter observational studies who underwent surgery for DCM was used as the source data. All patients underwent baseline and follow-up assessment at 2 years after surgery for functional, disability, and quality of life measurements (modified Japanese Orthopaedic Association [mJOA] scale, Neck Disability Index, SF-36 physical and mental component summary scores). Patients were separated into 4 groups according to their baseline modified frailty index 5-point scale score: not frail, pre-frail, frail, and severely frail. Differences among groups were analyzed at baseline and at 2 years after surgery, including change in scores (delta values) and the odds ratio of achieving the minimum clinically important difference (MCID) through univariate and multivariable logistic regression adjusting for age, approach, number of levels treated, and sex. A total of 757 patients (63% male) with a mean age of 56 (95% CI 55.5-57.2) years were included: 470 patients underwent an anterior approach, 310 had a posterior approach, and 23 had a combined anterior/posterior approach. A total of 50% (n = 378) of patients were classified as not frail, with 33% (n = 250) pre-frail, 13% (n = 101) frail, and 4% (n = 28) severely frail. The baseline mJOA score was significantly lower with increasing frailty (14.00 [95% CI 13.75-14.19] for not frail vs 9.71 [95% CI 9.01-10.42] for severely frail patients; p < 0.05), but the change at 2 years was not significantly different among all groups (2.43 [95% CI 2.16-2.71] for not frail vs 2.56 [95% CI 1.10-4.02] for severely frail). The SF-36 delta values were also not different among groups, but significantly worse at baseline with increasing frailty. The odds ratio of achieving MCID for mJOA was significantly higher in the not frail group (1.89 [95% CI 1.36-2.61]; p < 0.05) compared to the other frailty cohorts, which remained after adjusting for age, approach, levels treated, and sex. The odds ratio of achieving MCID for the SF-36 domains was similar among all frailty groups. Increasing frailty is associated with worse baseline functional and quality of life measures in patients undergoing surgery for DCM. Frailty does not affect the magnitude of improvement in outcome measures after surgery, but reduces the chance of achieving the MCID for functional impairment significantly. Preoperative frailty assessment can therefore help guide clinicians in managing expectations after surgery for DCM. Potentially modifiable factors should be optimized in frail patients preoperatively to enhance functional outcomes.

Long-Term Impacts of COVID-19 Pneumonia on Quality of Life: A Single Institutional Pilot Study

Many studies have demonstrated poor quality of life (QoL) at 3, 6, 12, and 24 months after coronavirus disease 2019 (COVID-19). However, these studies were limited due to cross-sectional design, a longer gap between visits, and lack of controls for comparison. Therefore, the aim of our prospective study was to assess the impact of COVID-19 pneumonia on QoL in both physical and mental health. A prospective study was conducted on adult patients with COVID-19 pneumonia. We used the 36-Item Short Form Health Survey (SF-36) and Euro Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L), EQ visual analogue scale (EQ-VAS), and Hospital Anxiety and Depression Scale to collect data at months, 1, 3, 6, 9, and 12. Thirty-eight patients with COVID-19 pneumonia and twenty-five healthy subjects were completely followed up on all visits. All domains of SF-36, except bodily pain and EQ-5D-5L of the patients, were lower than controls. There was an improvement of EQ-VAS and SF-36 including physical functioning, social functioning, and role limitation (physical problems) domains throughout study period in the COVID-19 pneumonia group. Adult patients who recovered from COVID-19 pneumonia had lower QoL which improved over the one-year follow-up period.

QUALITY OF LIFE OF A PATIENT AFTER ENDARTERECTOMY OF THE INTERNAL CAROTID ARTERY (ICA) FOLLOWINGAN ACUTE ISCHEMIC STROKE (AIS) DURING COVID-19

The aim of the study was to evaluate the quality of life of a patient af- terendarterectomy (CEA) of the Internal Carotid Artery (ICA) following an Acute ischemic stroke (AIS) during COVID-19.A right-handed, 51-year-old patient, a visual artist, single, in good health and no chronic illnesses to date, became infected with SARS-CoV-2 and contracted COVID-19. The presence of SARS-CoV-2 virus was confirmed by a RT PCR antigen test. The patient was hospitalized, and required mechanical ventilation at an Intensive Care Unit (ICU) before an acute ischemic stroke (AIS) onset. Except for untreated hypertension, her medical history was unremarkable. Her blood pressure was 180/100 mm Hg; her pulse was 76 beats per minute and was regular. AIS from the left middle cerebral artery (MCA) has resulted primarily in damage to the left hemisphere, and secondary effects on the right side resulting in body weakness and mild anomic aphasia. Magnetic resonance imaging (MRI) confirmed stroke and detected brain tissue damaged by an AIS. It revealed hyperintense foci in the T2 and FLAIR sequences, 21 mm in size in the left hemisphere of the brain. In search of the cause of AIS, CT angiography was performed. It revealed a large (90%) ICA occlusion. The patient was admitted to the emergency room at the Vascular Surgery Clinic with an Endovascular Subunit. The revascularization procedure (CEA) was performed under general endotracheal anesthesia with the use of the protocol and techniques (elaborated at the Department of Vascular Surgery and Endovascular Procedures, The John Paul II Hospital in Krakow). The CEA procedure improved her general health: she regained the ability to name objects and her HRQOL also improved in her perception. The improvement achieved was statistically significant. She returned to painting and functions well in society.The patient’s perception of HRQoL measured by the SF-36 domains was better after the CEA: a significant improvement in self-reported overall health has occured. The HRQoL outcome measures may be valuable in future clinical trials of comparing different methods of treatment offered after AIS.

Quality of Life and Pain in Patients With Chronic Pancreatitis.

The quality of life (QoL) of patients with chronic conditions is a function of factors associated with the illness, its natural course, and treatment as well as those related to the patient. Chronic pancreatitis (CP) is a critical public health problem. Chronic pancreatitis patients can experience chronic pain with different mechanisms, malabsorption, diabetes, and cachexia. Chronic pancreatitis (CP) is a critical public health problem. CP patients can experience chronic pain with different mechanisms, malabsorption, diabetes, and cachexia. The aim of the study was to assess the Quality of Life (QoL) of patients with CP and identify factors affecting QoL. 104 patients diagnosed with CP from the hospital in Wrocław, Poland, were included. The study was conducted using our own questionnaire, the World Health Organization Quality of Life-BREF (WHOQOL-BREF) scale, the 36-Item Short Form Health Survey (SF-36), and the Visual Analog Scale (VAS). The mean total SF-36 score was 47.7, with the highest mean rating for the physical functioning domain. The mean VAS pain score was 5.13. Pain intensity was significantly correlated with impairments in activities of daily living (P = 0.001), the need to reduce their duration (P = 0.001), and the performance of physical activity (P = 0.003). Comorbidities, education, and age have a significant relationship with only some domains of SF-36. One aspect that has an impact on QoL impairment is pain which perception is governed by the same brain regions in which abnormalities result in depression and anxiety. QoL in CP patients also depends on the patient's age, comorbidities, and level of education.

Validation of the Polish Version of Knee Outcome Survey Activities of the Daily Living Scale in a Group of Patients after Arthroscopic Anterior Cruciate Ligament Reconstruction.

The study aimed to assess the reliability, validity, and responsiveness of the Polish version of Knee Outcome Survey Activities of the Daily Living Scale (KOS-ADLS) in a group of patients after arthroscopic reconstruction of the anterior cruciate ligament (ACL). The study was a longitudinal study with repeated measures. One hundred and twelve subjects who qualified for arthroscopic ACL reconstruction (mean age = 31.8 years) were initially enrolled in this study. The Polish version of KOS-ADLS and Short Form-36 v. 2.0 (SF-36) were used. The Polish version of KOS-ADLS in subjects after ACL rupture demonstrated excellent internal consistency (Cronbach's alpha for KOS-ADLS- total = 0.91), and test-retest reliability using the intraclass correlation coefficient (ICC-total = 0.98). The standard error of measurement (SEM) value was 0.81 and the minimal detectable change (MDC) was 2.23 for KOS-ADLS-total. The validity analysis showed a moderate and low correlation between KOS-ADLS and different domains of SF-36 from r = 0.354 between KOS-ADLS activity and the physical component scale (PCS) of SF-36: to r = 0.206 between KOS-ADLS activity and the mental component scale (MCS) of SF-36. The Polish version of KOS-ADLS turned out to be a reliable, valid and responsive self-reported outcome measure, allowing for the self-assessment of symptoms and function related to the knee joint impairment after ACL reconstruction. Therefore, the scale can be applied in clinical practice and research.

Impact of Obstructive Sleep Apnea on Health-Related Quality of Life in Patients With Partial Laryngectomy for Laryngeal Cancer.

Objectives: To evaluate the possible risk factors of obstructive sleep apnea (OSA) and its impact on the health-related quality of life (HRQoL) in patients with partial laryngectomy for laryngeal cancer. Methods: A cross-sectional method was used to carry out this study. Patients who underwent partial laryngectomy for laryngeal cancer completed overnight polygraphy (PG) home sleep tests and quality of life questionnaires. The Medical Outcome Study 36-item Short-Form Health Survey (SF-36) questionnaire was used to investigate the factors influencing HRQoL. Results: A total of 59 patients completed the PG tests and quality of life questionnaires, with 74.6% demonstrating evidence of OSA. There were significant differences in tumor area and neck dissection between OSA group and non-OSA groups. Based on sleep-related parameters, patients were divided into cluster 1 (n = 14) and cluster 2 (n = 45) using principal component analysis combined with K-means clustering. Two clusters had significantly different scores of body pain, general health, and health transition in SF-36 domains. Independent factors associated with general health were identified as tobacco use (OR = 4.716), alcohol use (OR = 3.193), and OSA-related condition (OR = 11.336). Conclusions: Larger tumor area and neck dissection might be associated with an increased risk for developing OSA in patients with partial laryngectomy for laryngeal cancer. OSA partially mediated the effect on physical health, including body pain, general health, and health transition. It is important to be aware of the potential impact of OSA on diminished HRQoL of these patients.

Oral Health-Related Quality of Life and Mental Health Impairment in Patients Affected by Medication-Related Osteonecrosis of the Jaws: A Case-Control Pilot Study.

In the present case-control study, the impact of medication-related osteonecrosis of the jaws (MRONJ) on patients' oral health-related quality of life (OHRQoL), overall quality of life (QoL), and psychological status was evaluated using a set of questionnaires. These questionnaires included the Oral Health Impact Profile-14 (OHIP-14), the Short Form 36 Health Survey Questionnaire (SF-36), and the hospital anxiety and depression scale (HADS). A total of 25 MRONJ patients and 25 controls were included in the study. The results showed that MRONJ patients had a significantly poorer OHRQoL (OHIP-14 score p-value: 0.003) and lower general QoL, particularly in the domains of "physical functioning", "physical role", "body pain", "general health", and "vitality" in the SF-36 questionnaire (p-values: 0.001, 0.001, 0.013, 0.001, and 0.020). Although there were no significant differences between the groups in the SF-36 domains of "social functioning", "emotional role", and "mental health", the mean sub-scores of the HADS, specifically the depression and anxiety scores (HADS-D and HADS-A), were significantly higher in MRONJ patients (p-values: 0.002 and 0.009). However, the "mental health" domain of the SF-36 questionnaire showed a correlation with both HADS-A and HADS-D scores (p-values: 0.003 and 0.031). Therefore, a comprehensive clinical examination of MRONJ patients should include the assessment of OHRQoL, overall QoL, and psychological profile using different questionnaires. This approach aims to gather detailed information about patients' physical and psychological well-being, enabling the development of tailored treatments.

Quality of Life, Fatigue, and Physical Symptoms Post-COVID-19 Condition: A Cross-Sectional Comparative Study.

The magnitude of post-COVID-19 syndrome was not thoroughly investigated. This study evaluated the quality of life and persistence of fatigue and physical symptoms of individuals post-COVID-19 compared with noninfected controls. The study included 965 participants; 400 had previous COVID-19 disease and 565 controls without COVID-19. The questionnaire collected data on comorbidities, COVID-19 vaccination, general health questions, and physical symptoms, in addition to validated measures of quality of life (SF-36 scale), fatigue (fatigue severity scale, FSS), and dyspnea grade. COVID-19 participants complained more frequently of weakness, muscle pain, respiratory symptoms, voice disorders, imbalance, taste and smell loss, and menstrual problems compared to the controls. Joint symptoms, tingling, numbness, hypo/hypertension, sexual dysfunction, headache, bowel, urinary, cardiac, and visual symptoms did not differ between groups. Dyspnea grade II-IV did not differ significantly between groups (p = 0.116). COVID-19 patients scored lower on the SF-36 domains of role physical (p = 0.045), vitality (p < 0.001), reported health changes (p < 0.001), and mental-components summary (p = 0.014). FSS scores were significantly higher in COVID-19 participants (3 (1.8-4.3) vs. 2.6 (1.4-4); p < 0.001). COVID-19 effects could persist beyond the acute infection phase. These effects include changes in quality of life, fatigue, and persistence of physical symptoms.

A Prospective Cohort Study (OUTSTRIP-COVID) on Functional and Spirometry Outcomes in COVID-19 ICU Survivors at 3 Months.

COVID-19 pandemic resulted in a significant number of critical care admissions secondary to severe pneumonia and acute respiratory distress syndrome. We evaluated the short-, medium- and long-term outcomes of lung function and quality of life in this prospective cohort study and reported the outcomes at 7 weeks and 3 months from discharge from intensive care unit. A prospective cohort study of ICU survivors with COVID-19 was conducted from August 2020 to May 2021 to evaluate baseline demographic and clinical variables as well as determine lung function, exercise capacity, and health-related quality of life (HRQOL) using spirometry and 6-minute walk test (6MWT) conducted in accordance with American Thoracic Society standards, and SF-36 (Rand), respectively. SF-36 is a generic 36 question standardized health survey. Descriptive and inferential statistics (alpha = 0.05) were used to analyse the data. At baseline, 100 participants were enrolled in the study of whom 76 followed up at 3 months. Majority of the patients were male (83%), Asians (84%) and less than 60 years of age (91%). HRQOL showed significant improvement in all domains of SF-36, except in emotional wellbeing. Spirometry variables also showed significant improvement in all variables over time with greatest improvement in percentage predicted Forced expiratory volume 1 (79% vs 88% p < 0.001). 6MWT showed significant improvement in variables of walk distance, dyspnea, and fatigue with greatest improvement in change in oxygen saturation (3% vs 1.44% p < 0.001). Intubation status did not impact the changes in SF-36, spirometry or 6MWT variables. Our findings suggest that ICU survivors of COVID-19 have significant improvement in their lung function, exercise capacity and HRQOL within 3 months of ICU discharge regardless of intubation status.

Validation of the Short-Form 36 for Adolescents Undergoing Reduction Mammaplasty.

Patients aged 12-21 years were prospectively recruited between 2008 and 2021 to unaffected or macromastia cohorts. Patients completed four baseline surveys: SF-36, Rosenberg Self-esteem Scale, Breast-related Symptoms Questionnaire, and Eating Attitudes Test. Surveys were repeated at 6 and 12 months postoperatively (macromastia cohort), and at 6 and 12 months from baseline (unaffected cohort). Content, construct, and longitudinal validity were assessed. A total of 258 patients with macromastia (median age: 17.5 years), and 128 unaffected patients (median age: 17.0 years) were included. Content validity was established, and construct validity was fulfilled: internal consistency was confirmed for all domains (Cronbach alpha >0.7); convergent validity was satisfied through expected correlations between the SF-36 and Rosenberg Self-esteem Scale, Breast-related Symptoms Questionnaire, and Eating Attitudes Test, and known-groups validity was established through significantly lower mean scores in all SF-36 domains in the macromastia cohort compared with unaffected patients. Longitudinal validity was established by significant improvements in domain scores from baseline to 6 and 12 months postoperatively in patients with macromastia (P < 0.05, all). The SF-36 is a valid instrument for adolescents undergoing reduction mammaplasty. Although other instruments have been used for older patients, we recommend the SF-36 when assessing health-related quality of life changes in younger populations.

0473 Multi-outcome of mandibular advancement device in Obstructive Sleep Apnea with different polysomnographic phenotype

Abstract Introduction The association of mandibular advancement device (MAD) treatment response and polysomnographic phenotype in patients with obstructive sleep apnea (OSA) has not been fully elucidated. We hypothesized MAD response would be associated with two polysomnographic phenotypes, including sleep stage and positional dependency in treatment-naïve patients with moderate-severe obstructive OSA. Methods This retrospective study recruited OSA patients with AHI ≥15/h, aged 20 to 80, treatment naïve, and received MAD treatment for more than three months. Positional phenotype included supine predominant (supine-p) and non-positional OSA. Sleep stage phenotype included REM-predominant (REM-p), NREM-predominant (NREM-p), and stage-independent (SI) OSA. MAD response was defined as criterion 1: residual AHI&amp;lt; 5/h with &amp;gt;50% reduction, and criterion 2: residual AHI&amp;lt; 10/h with &amp;gt;50% reduction. Outcomes included the change in PSG parameters, habitual latency of sleep onset and sleep hour, Epworth sleepiness scale, excessive daytime sleepiness, depression, physical, vitality and mental health domain of SF-36, and in-lab bedtime and wake blood pressure (BP). Results 379 patients with median age of 52.2 years, BMI of 26 kg/m2, 78.1% of men, and AHI of 28.2/h were recruited. Supine-p and REM-p OSA had lower baseline AHI and desaturation. The overall response rate were 34.7% (criterion 1 ) and 56% (Criterion 2). Supine-p OSA had higher response rate than non-positional OSA (criterion 1: 42.2% vs. 20.3%; criterion 2: 64.3% vs. 32.5%), while NREM-p OSA had lower response rate than REM-p and SI (REM-p vs. NREM-p vs. SI: criterion 1: 43.9% vs. 9.7% vs. 34.2%; criterion 2: 54.5% vs. 41.9% vs. 53.3%). Despite the more reduction in AHI, desaturaiotn, and arousal in responders, there was no differences in change of ESS, EDS, sleep pattern, depression, SF 36 domain, and BP between responders and non-responders which remained unchanged after stratified with sleep stage and position phenotypes. Conclusion Non-positional and NREM-predominant OSA had lower responses rate to MAD treatment. There were no differences in non-breathing outcomes between responders and nonresponders regardless of sleep stage and positional phenotype. Support (if any) The work was supported by grants from the National Science and Technology Council, Taiwan (NSTC 111-2314-B-002-293); Ministry of Science and Technology, Taiwan (MOST 109-2314-B-002-252); National Taiwan University Hospital (NTUH 107-19, 111-X0033, 111-S0298)

Tremor in Patients with Relapsing-Remitting Multiple Sclerosis: Clinical Characteristics and Impact on Quality of Life.

Little is known about the prevalence and clinical characteristics of tremors in patients with multiple sclerosis (MS), their associated clinical disability, and their impact on quality of life (QoL). This study aimed to investigate the frequency and types of tremors in patients with relapsing remitting MS (RRMS) in remission, and their impact on patients' QoL. A total of 250 patients with RRMS in remission were examined for tremors. All patients were assessed using the Expanded Disability Status Scale (EDSS). Patients with tremors underwent further assessment using the Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS), the Beck Depression Inventory (BDI), the Montreal Cognitive Assessment (MoCA) scale, and the Short Form 36 Health Survey Questionnaire (SF-36). Brain MRI was obtained for a subgroup of patients. Tremors were detected in 36 patients (14.4%) and were associated with significantly worse EDSS scores, BDI (P = 0.021), MoCA, most SF-36 domains, higher total and last year relapses (P < 0.001) and longer disease duration (P = 0.027). Patients with tremors showed higher lesion load (P = 0.007), more infratentorial (P ≤ 0.001), cerebellar and diencephalic lesions (P = 0.024), and cortical atrophy (P = 0.012). Total FTMTRS was significantly correlated to age, EDSS, and physical functioning. Dystonia was associated with tremors in 17 patients (6.8% of total RRMS patients and 47.2% of patients with tremors). The current study confirms the common occurrence of tremors and their subtypes among patients with RRMS with mild disability and demonstrates their association with increased disability and impaired QoL.

PROMIS Profile-29 is a valid instrument with distinct advantages over legacy instruments for measuring the quality of life in chronic liver disease.

The Patient-Reported Outcomes Measurement Information System (PROMIS) is increasingly used to measure health-related quality of life, yet, it has not been well-studied in chronic liver disease (CLD). This study compares PROMIS Profile-29 to Short-Form Health Survey (SF-36) and Chronic Liver Disease Questionnaire (CLDQ) in patients with CLD. In all, 204 adult outpatients with CLD completed PROMIS-29, CLDQ, SF-36 and usability questionnaires. Mean scores were compared between groups, the correlation between domain scores was assessed, and floor/ceiling effects were calculated. Etiologies of CLD were NAFLD (44%), hepatitis C (16%), and alcohol (16%). Fifty-three percent had cirrhosis and 33% were Child-Pugh B/C with a mean model for end-stage liver disease score of 12.0. In all 3 tools, the poorest scores were in physical function and fatigue. The presence of cirrhosis or complications was associated with worse scores in most PROMIS Profile-29 domains, indicating known group validity. Strong correlations ( r ≥ 0.7) were present between Profile-29 and SF-36 or CLDQ domains measuring similar concepts, indicating strong convergent validity. Profile-29 was completed faster than SF-36 and CLDQ (5.4 ± 3.0, 6.7 ± 3.3, 6.5 ± 5.2min, p = 0.003) and rated equally on usability. All CLDQ and SF-36 domains reached the floor or ceiling, while none were noted for Profile-29. These floor/ceiling effects were magnified when assessed in those with and without cirrhosis, indicating the improved depth of measurement by Profile-29. Profile-29 is a valid, more efficient, well-received tool that provides an improved depth of measurement when compared to SF-36 and CLDQ and, therefore, an ideal tool to measure general health-related quality of life in CLD.

Long Term Results of a Randomised Trial of Stenting of the Superficial Femoral Artery for Intermittent Claudication

Primary stenting of the superficial femoral artery (SFA) in intermittent claudication (IC) has been shown to increase health related quality of life (HRQoL) after 12 and 24 months. An extended follow up of HRQoL 36 and 60 months after randomisation is presented. A multicentre randomised controlled trial was conducted at seven vascular clinics in Sweden between 2010 and 2020. One hundred patients randomised to either primary stenting and best medical treatment (BMT; n = 48) or BMT alone (n = 52) were followed for 60 months. HRQoL, assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 36 and 60 months after randomisation, was the primary outcome. Walking Impairment Questionnaire (WIQ) score, re-interventions, progression to chronic limb threatening ischaemia (CLTI), amputation, and death were secondary outcomes. At the 36 month follow up, the stent group (n = 32) had statistically significantly better scores in the SF-36 domain “Role Physical” (p = .023) and the Physical Component Summary (p = .032) compared with the control group (n = 30); however, there was no statistically significant difference in EQ5D scores (p = .52). WIQ was statistically significantly better in the stent group compared with the control group (p = .029) at 36 months. At the 60 month follow up, no statistically significant difference in HRQoL was seen between patients in the stent (n = 31) and control groups (n = 32). Crossover from the control group to the stent group was 25% at 60 months. There were no differences in progression to CLTI, amputation (2.1% vs. 1.9%), or mortality (14.6% vs. 15.4%) between groups. In patients with IC caused by isolated SFA lesions, primary stenting conferred benefits to HRQoL until 36 months from treatment vs. BMT alone, but these benefits were no longer detectable at 60 months, where a high crossover rate affected the power of the final analysis.

The relationship between clinical phenotype and kallikrein-kinin bioregulation in different forms of arthritis

ObjectivePatients with rheumatoid arthritis (RA) have shown increased levels of neutrophils generating kallikrein-kinin peptides in blood which are potent mediators of inflammation. This study investigated the association between the bioregulation of kinin-mediated inflammation with the clinical, quality of life, and imaging characteristics (e.g. ultrasonography) of different arthritides.MethodsPatients with osteoarthritis (OA, n = 29), gout (n = 10) and RA (n = 8) were recruited and screened for clinical symptoms, quality of life, and ultrasonographical assessment of arthritis. Blood neutrophils were assessed for the expression of bradykinin receptors (B1R and B2R), kininogens and kallikreins by immunocytochemistry with visualization by bright field microscopy. Levels of plasma biomarkers were measured by ELISA and cytometric bead array.ResultsQuality of life (SF-36 domains and summary scores; including pain; and, HAQ) was similar across OA, gout and RA patients; with the exception of worse physical functioning scores between OA and gout patients. Synovial hypertrophy (on ultrasound) differed between groups (p = 0.001), and the dichotomised Power Doppler (PD) score of greater than or equal to 2 (PD-GE2) was marginally significant (p = 0.09). Plasma IL-8 were highest in patients with gout followed by RA and OA (both, P < 0.05). Patients with RA had higher plasma levels of sTNFR1, IL-1β, IL-12p70, TNF and IL-6, compared to OA and gout patients (all, P < 0.05). Patients with OA had higher expression of K1B and KLK1 on blood neutrophils followed by RA and gout patients (both, P < 0.05). Bodily pain correlated with B1R expression on blood neutrophils (r = 0.334, p = 0.05), and inversely with plasma levels of CRP (r = −0.55), sTNFR1 (r = −0.352) and IL-6 (r = −0.422), all P < 0.05. Expression of B1R on blood neutrophils also correlated with Knee PD (r = 0.403) and PD-GE2 (r = 0.480), both P < 0.05.ConclusionsPain levels and quality of life were similar between patients with OA, RA and gout with knee arthritis. Plasma inflammatory biomarkers and B1R expression on blood neutrophils correlated with pain. Targeting B1R to modulate the kinin-kallikrein system may pose as a new therapeutic target in the treatment of arthritis.

Validity of the German Menière's Disease Patient-Oriented Symptom Severity Index

The MD POSI is a disease-specific questionnaire to determine the health-related quality of life (HRQoL) of patients with Menière's disease (MD). Validity and reliability of the German translation of the MD POSI. Prospective data analysis of a patient group with vertigo (n = 162), which was treated in the otorhinolaryngology of a University Hospital from 2005-2019. A clinical selection was made according to the new Bárány classification in a "definite" and "probable" Menière's disease. HRQoL was assessed using the German translation of the MD POSI, the Vertigo Symptom Score (VSS) and the Short Form (SF-36). Reliability was measured by Cronbach's α and test-retesting after 12 months and again 2 weeks later. Content and agreement validity were examined. Cronbach α values greater than 0.9 indicated good internal consistency. There was no statistically significant difference from baseline to 12 months, except for the subscore "during the attack". There were significant positive correlations between the VSS overall/VER/AA and the overall index of the MD POSI and negative significant correlations with the SF-36 domains physical functioning, physical role functioning, social functioning, emotional role functioning, mental well-being. There were low SRM (standardized response mean) values below 0.5. The German translation of the MD POSI is a valid and reliable instrument to evaluate the impact of MD on patients' disease-specific quality of life.