36-Item Short Form Health Survey Research Articles

Effects of Mecobalamin on the Functional Outcomes of Complex Regional Pain Syndrome Type 1 of the Foot and Ankle.

Because of the unclear pathophysiology and the lack of consensus on the gold standard treatment of complex regional pain syndrome (CRPS), management requires a multidisciplinary approach, with the use of various treatment modalities. Nonetheless, no studies have ever been conducted to uncover the potential of mecobalamin as a treatment for CRPS type 1. Hence, the aim of this clinical trial was to evaluate the effects of mecobalamin on the functional outcomes of patients with CRPS type 1 of the foot and ankle, the total amount of pregabalin ingested, and the duration of pregabalin use in each patient. Forty-seven patients diagnosed with acute CRPS type 1 of the foot and ankle were recruited. Patients were randomly allocated into a control group (23 patients) and a mecobalamin group (24 patients), both receiving similar pain control medications and rehabilitation programs. Three divided doses of mecobalamin 1.5 mg/d were provided to the mecobalamin group for the first 3 months, whereas a placebo was administered to the control group. Data were collected from the pretreatment period, and from 1, 3, 6, and 12 months following the treatment. Both groups had similar demographics. The mean Foot and Ankle Ability Measure (FAAM) activities of daily living (ADL) and FAAM-sport scores in the mecobalamin group at 3 months were 74.5 ± 17.9 and 56.3 ± 22.9, whereas the mean FAAM-ADL and FAAM-sport scores in the placebo group at 3 months were 62.2.5 ± 15.2 and 43.4 ± 14.9, respectively (P < .05). The 36-Item Short Form Health Survey (SF-36) mental health subscale after 3 months were 83.3 ± 9.5 points and 75.8 ± 12.6 points in the mecobalamin and placebo group, respectively (P < .05). However, at other time points of assessment (1, 6, and 12 months), the improvement in symptoms was not distinguishable between the 2 groups. Both the amount and duration of total pregabalin required to achieve similar improvements in pain scores were significantly lower in the mecobalamin group than the control group. This small study revealed an improvement of the functional outcomes in patients with CRPS type 1 of the foot and ankle who received mecobalamin instead of a placebo at 3 months that was not sustained at 6 and 12 months. We identified an average 39% total reduction in the amount of total pregabalin used in the mecobalamin group in the first 12 months.

Mycophenolate Mofetil and New-Onset Systemic Lupus Erythematosus

Anti-double-stranded DNA (dsDNA) antibody has been reported to have a close relationship with systemic lupus erythematosus (SLE) flares and participates in the pathogenesis of lupus nephritis (LN) as well as causing damage to other organs. However, whether early use of mycophenolate mofetil (MMF) could prevent SLE flares is not clear. To assess the efficacy and safety of MMF plus prednisone and hydroxychloroquine sulfate compared with prednisone and hydroxychloroquine sulfate alone in patients with SLE. This investigator-initiated, multicenter, observer-blinded randomized clinical trial enrolled 130 participants aged 18 to 65 years and was conducted in 3 hospitals across China. Treatment-naive patients with newly diagnosed SLE, a high titer of anti-dsDNA antibody, and no major organ involvement were included. The study was started September 1, 2018, and the follow-up was completed September 30, 2021. Data were analyzed from December 1, 2021, to March 31, 2022. Patients were randomized 1:1 to receive oral prednisone (0.5 mg/kg/d) and hydroxychloroquine sulfate (5 mg/kg/d) (control group) or prednisone (0.5 mg/kg/d) and hydroxychloroquine sulfate (5 mg/kg/d) plus MMF (500 mg twice daily) (MMF group) for 96 weeks. The primary outcome was the proportion of patients presenting with flares according to the Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Flare Index. The secondary outcomes included the proportion with lupus low disease activity state at week 96, 36-Item Short Form Health Survey scores before and after treatment, proportion of adverse events (AEs), and changes in SLEDAI-2000 scores and prednisone doses. Among 130 randomized patients (mean [SD] age, 34.5 [12.5] years; 112 [86.2%] women), 119 (91.5%) completed the follow-up. The risk of severe flare was significantly lower in the MMF group (7 of 65 [10.8%]) vs the control group (18 of 65 [27.7%]) (relative risk [RR], 0.39 [95% CI, 0.17-0.87]; P = .01). Additionally, 1 of 65 patients in the MMF group (1.5%) and 9 of 65 in the control group (13.8%) manifested LN (RR, 0.11 [95% CI, 0.01-0.85]; P = .008). Most common serious study drug-related AEs were infections (20 of 65 [30.8%] in the control group and 22 of 65 [33.8%] in the MMF group). The findings of this randomized clinical trial suggest that MMF may reduce the rate of severe flare and lower the incidence of LN in patients with new-onset SLE and a high titer of anti-dsDNA antibody without major organ involvement. Chinese Clinical Trial Registry: ChiCTR1800017540.

Mental Health and Quality of Life of Patients with Differentiated Thyroid Cancer Pre and Post Radioactive Iodine Treatment: A Prospective Study.

Background: Although patients with differentiated thyroid cancer (DTC) have a good prognosis, their long-term clinical course can influence their mental health and their health-related quality of life (HRQoL). However, few studies have evaluated the psychological factors that influence subsequent HRQoL in this population, particularly during the initial treatment stage. Methods: In this 1-month cohort study, we evaluated depressive and anxiety symptoms and HRQoL of patients with DTC and examined possible predictors of further HRQoL impairment. Results: In total, 181 patients completed questionnaires where they self-rated their psychological status (the Chinese Health Questionnaire [CHQ], Taiwanese Depression Questionnaire [TDQ]) and HRQoL (the 36-item Short Form Health Survey [SF-36]) at baseline and 1 month after radioactive iodine (RAI) therapy. Compared with the general Taiwanese population, patients with DTC reported a worse HRQoL in all dimensions of the SF-36. Multivariate regression models indicated that anxiety and depressive symptoms were inversely correlated with some dimensions (physical functioning, bodily pain, and general health perceptions for the CHQ; role limitations due to physical problems and social functioning for the TDQ). However, psychiatric follow-up and treatment history were significantly associated with physical functioning and role limitations owing to the physical problem dimensions of HRQoL. Conclusions: In conclusion, although anxiety and depressive symptoms may negatively affect certain HRQoL domains, psychiatric follow-up can improve the physical dimensions.

Association of Quality of Life and Visual Function in Glaucoma with Tests of Structure and Function.

In addition to standard automated perimetry tests, contrast sensitivity testing and macular analyses may predict changes in the quality of life in patients at different stages of glaucoma. To examine the relationship between functional and structural tests of visual function and the 25-item National Eye Institute-Visual Function Questionnaire (NEI-VFQ-25) and the 36-item Short Form Health Survey (SF-36) in patients with different stages of glaucoma. Standard automated perimetry tests, optical coherence tomography scans, and contrast sensitivity (CS) testing were prospectively performed in 160 patients with glaucoma. The Hoddap-Parrish-Anderson staging system was used for glaucoma staging. Health-related quality of life questionnaires (NEI-VFQ-25, SF-36) were also administered to all patients. The study group comprised 29 patients with suspected glaucoma, 104 with mild glaucoma, 15 with moderate glaucoma, and 12 with severe glaucoma. The mean total score of the NEI-VFQ-25 was 88.8±8.2. The SF-36 did not show a significant correlation with the data on functional and structural tests of visual function, whereas the NEI-VFQ-25 showed a low to moderate correlation (r=0.212--0.492). Vision parameters can explain up to 18.6% of the total score of the NEI-VFQ-25. CS was the only function significantly correlated with glaucoma suspects, while in the early stages, VA was the strongest correlated function with the NEI-VFQ-25 total score (P=0.003 and r=0.551; P=0.001 and r=0.343, respectively). The impact of the visual field on vision-related quality of life increased in the advanced stages (P=0.013, r=0.688). The macular retinal ganglion cell plus inner plexiform layer thickness remained associated with NEI-VFQ-25 at all stages of glaucoma (r=0.335-0.802). The NEI-VFQ-25 total score and most of the subscales were correlated with the physical and mental component summary scores of the SF-36 (r=0.159-0.587). VA correlated the most with quality of life in glaucoma patients, as measured with the NEI-VFQ-25 to assess quality of life in glaucoma. The impact of visual functions on quality of life varies at different stages of glaucoma.

Frailty as a sequela of burn injury: a post hoc analysis of the “RE-ENERGIZE” multicenter randomized-controlled trial and the National Health Interview Survey

BackgroundWith advancements in burn treatment and intensive care leading to decreased mortality rates, a growing cohort of burn survivors is emerging. These individuals may be susceptible to frailty, characterized by reduced physiological reserve and increased vulnerability to stressors commonly associated with aging, which significantly complicates their recovery process. To date, no study has investigated burns as a potential risk factor for frailty. This study aimed to determine the short-term prevalence of frailty among burn survivors’ months after injury and compare it with that of the general population.MethodsA post hoc analysis was conducted on the Randomized Trial of Enteral Glutamine to Minimize the Effects of Burn Injury (RE-ENERGIZE) trial, an international randomized-controlled trial involving 1200 burn injury patients with partial- or full-thickness burns. Participants who did not complete the 36-Item Short Form Health Survey (SF-36) questionnaire were excluded. Data for the general population were obtained from the 2022 National Health Interview Survey (NHIS). Frailty was assessed using the FRAIL (Fatigue, Resistance, Ambulation, Illness, Loss of weight) scale. Due to lack of data on loss of weight, for the purposes of this study, malnutrition was used as the fifth variable. Illness and malnutrition were based on admission data, while fatigue, resistance, and ambulation were determined from post-discharge responses to the SF-36. The burn cohort and general population groups were matched using propensity score matching and compared in terms of frailty status. Within the burn group, patients were divided into different subgroups based on their frailty status, and the differences in their (instrumental) activities of daily living (iADL and ADL) were compared. A multivariable analysis was performed within the burn cohort to identify factors predisposing to frailty as well as compromised iADL and ADL.ResultsOut of the 1200 burn patients involved in the study, 600 completed the required questionnaires [follow-up time: (5.5 ± 2.3) months] and were matched to 1200 adults from the general population in the U.S. In comparison to the general population, burn patients exhibited a significantly higher likelihood of being pre-frail (42.3% vs. 19.8%, P < 0.0001), or frail (13.0% vs. 1.0%, P < 0.0001). When focusing on specific components, burn patients were more prone to experiencing fatigue (25.8% vs. 13.5%, P < 0.0001), limited resistance (34.0% vs. 2.7%, P < 0.0001), and restricted ambulation (41.8% vs. 3.8%, P < 0.0001). Conversely, the incidence rate of illness was observed to be higher in the general population (1.2% vs. 2.8%, P = 0.03), while no significant difference was detected regarding malnutrition (2.3% vs. 2.6%, P = 0.75). Furthermore, in comparison with robust burn patients, it was significantly more likely for pre-frail and frail patients to disclose compromise in ADL and iADL. The frail cohort reported the most pronounced limitation.ConclusionsOur findings suggest a higher incidence of post-discharge frailty among burn survivors in the short-term following injury. Burn survivors experience compromised fatigue, resistance, and ambulation, while rates of illness and malnutrition were lower or unchanged, respectively. These results underscore the critical need for early identification of frailty after a burn injury, with timely and comprehensive involvement of a multidisciplinary team including burn and pain specialists, community physicians, physiotherapists, nutritionists, and social workers. This collaborative effort can ensure holistic care to address and mitigate frailty in this patient population.

Validation of the HIV/AIDS-Targeted Quality of Life (HAT-QOL) for Evaluation of Health-related Quality of Life in People Living with HIV/AIDS in Brazil.

HIV/AIDS-Targeted Quality of Life (HAT-QOL) is an instrument for evaluating health-related quality of life (HRQOL) in people living with HIV (PLWHIV). This has been adapted into Brazilian Portuguese, but its dimensional structure has not been analyzed. This study evaluated the psychometric properties of the Brazilian Portuguese version of the HAT-QOL, using a sample of 319 PLWHIV in Salvador, Brazil. The study performed Exploratory Factor Analysis (EFA) to assess the HAT-QOL dimensional structure. The analysis used a polychoric correlation matrix, Robust Diagonally Weighted Least Squares (RDWLS) as an extraction method, Parallel Analysis for factor retention, robust promin as oblique rotation, and Generalized H-index (G-H) for construct replicability of each factor. Model adequacy was assessed using the Root Mean Square Error of Approximation (RMSEA), Comparative Fit Index (CFI), and Tucker-Lewis Index (TLI). Concurrent validity was evaluated with the 36-item Short Form Health Survey, version 2 (SF-36v2). EFA identified a HAT-QOL six-factor solution: Financial Worries, Sexual Function, Medication Concerns, Life Satisfaction, Health Worries, and Overall Function. This solution showed high G-H indexes, concurrent validity, and satisfactory adequacy indexes (X2 = 231.345, df = 291, p < 0,001; RMSEA = 0.001, CFI = 0.999, TLI = 1.028). HIV Mastery, Disclosure Worries, and Provider Trust domains were not retained in EFA and did not have evidence of concurrent validity. This study proposed a HAT-QOL six-factor model for measuring HRQOL in the Brazilian PLWHIV. Future research could help identify another latent construct from not-included domains.

Effect of oblique insertion at ashi point with long needle on joint function in female patients with knee osteoarthritis of early and middle stages

To compare the improvement of joint function in female patients with early-middle-stage knee osteoarthritis (KOA) treated by oblique insertion at ashi point with long needle and oral celecoxib capsule. A total of 105 female patients with early-middle-stage KOA were randomly divided into an observation group (65 cases, 6 cases dropped out, 3 cases were discontinued) and a control group (40 cases, 6 cases dropped out, 2 cases were discontinued). Patients in the observation group were treated with oblique insertion at ashi point (hard knots of quadriceps femoris, hamstring muscle, popliteal muscle, etc.) with long needle, once every other 3 days, twice a week, for a total of 2 weeks. Patients in the control group were treated with oral celecoxib capsules, 0.2 g each time, once a day for 2 weeks. Both groups started functional exercise after 2 weeks of treatment. The joint function score of Western Ontario and McMaster Universities osteoarthritis index (WOMAC) and pain visual analogue scale (VAS) score of the two groups were observed before and after treatment and after 6 weeks of treatment completion (follow-up), the 12-item short-form health survey (SF-12) score was compared between the two groups before treatment and in follow-up, and the safety of the two groups was evaluated. After treatment and during the follow-up, the joint function scores of WOMAC and VAS scores of the two groups were lower than those before treatment (P<0.05). During the follow-up, the joint function scores of WOMAC and VAS scores were lower than those after treatment (P<0.05), and the SF-12 scores were higher than those before treatment (P<0.05) in the two groups. After treatment, the joint function score of WOMAC of the observation group was lower and the VAS score was higher than those of the control group (P<0.001, P<0.01). During the follow-up, the SF-12 score of the observation group was higher than that of the control group (P<0.05). No serious adverse reactions occurred in both groups. The treatment of oblique insertion at ashi point with long needle can improve the knee joint function and quality of life of female patients with early-middle-staqe KOA, which is better than oral celecoxib capsule.

Analysis of disease burden in patients with hereditary angioedema from Japan by patient-reported outcomes.

Hereditary angioedema (HAE) symptoms can vary greatly. Disease burden evaluation is essential for providing adequate treatments for patients. Patient-reported outcome measures (PROMs), including the 12-Item Short Form Health Survey (SF-12), the Angioedema Quality of Life (AE-QoL), the Hospital Anxiety and Depression Scale (HADS), and the Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaires, were collected in 2021, before modern medications for long-term prophylaxis (LTP) of HAE were licensed in Japan. Patients also reported their HAE attack frequency as "annual" (several attacks annually), "monthly" (several attacks monthly) or "weekly" (several attacks weekly). Multiple linear regression analyses were conducted on the relationship between independent parameters (sex, age, attack frequency, HAE type, and HADS scores) and dependent parameters (AE-QoL and SF-12 scores). Fifty-four patients reported PROMs. All PROMs showed substantial health-related quality of life (HRQoL) impairment. Overall, the higher the attack frequencies, the greater the reported impairment in the PROMs tended to be. In multiple linear regression analyses, higher AE-QoL Fatigue/Mood and Fears/Shame domain scores (greater impairment) were associated with higher HADS anxiety subscale scores; higher AE-QoL total scores (greater HRQoL impairment) and lower SF-12 Physical and Mental Health Composite scores (greater general health impairment) were associated with higher HADS depression subscale scores. Patients with monthly or weekly HAE attacks reported numerically low absenteeism and numerically high presenteeism and work productivity loss as measured by the WPAI:SHP questionnaire. In this study, conducted before modern LTP options were available in Japan, patients with HAE reported notable impairment in HRQoL and work productivity. Weekly or monthly HAE attack frequencies were associated with a high disease burden. Furthermore, a substantial number of patients reported notable fatigue/mood impairment as measured by the AE-QoL and depression as measured by the HADS regardless of attack frequency. These results provide a basis for future studies evaluating the effect of LTP on the clinical manifestations and HRQoL in patients with HAE.

Psychometric analysis and validation of the SF-34 PREG: An adaptation of the SF-36 for assessing quality of life in pregnant women.

This study aims to perform a psychometric analysis of the 36-item short form health survey (SF-36) in a population of pregnant women and validate an adapted version of the instrument to measure health-related quality of life specific to pregnancy. A cross-sectional study design was carried out with data collection between 7 and 36 weeks of gestation, with a total sample of 547 pregnant women divided into two randomized subsamples. Data were collected between September 2021 and April 2023. An exploratory factor analysis was initially performed on one subsample, followed by a confirmatory factor analysis on the other. Internal consistency was assessed using Cronbach's alpha and McDonald's omega, and correlations between factors were analyzed. Results from the exploratory factor analysis proposed a seven-factor model explaining 56% of the variance. All proposed dimensions achieved Cronbach's alpha scores above 0.75, with a total test score of 0.92. Furthermore, all dimensions exhibited positive and statistically significant correlations. Bartlett's test of sphericity and the Kaiser-Meyer-Olkin test yielded values of 5599 (P < 0.001) and 0.871, respectively. The confirmatory factor analysis reaffirmed this model with good fit indices: χ2 792 (P < 0.001), comparative fit index (CFI) and Tucker-Lewis index (TLI) >0.90, and standardized root mean square residual (SRMR) and root mean square error of approximation (RMSEA) <0.06. This study developed and validated the "SF-34 PREG," an adapted version of the SF-36, specifically designed for pregnant women. The SF-34 PREG demonstrated high reliability and a robust factorial structure, making it a more precise and relevant tool for assessing health-related quality of life during pregnancy. Although it does not include the social functioning dimension of the original SF-36, the SF-34 PREG offers improved relevance and accuracy for this specific population. Further research and clinical use of the SF-34 PREG are recommended.

Early Improvements with Guselkumab Associate with Sustained Control of Psoriatic Arthritis: Post hoc Analyses of Two Phase 3 Trials.

Patterns of treatment response can inform clinical decision-making. This study assessed the course and impact of achieving minimal clinically important improvement (MCII) in clinical measures and patient-reported outcomes (PROs) with guselkumab in patients with active psoriatic arthritis (PsA). Post hoc analyses evaluated 1120 patients with PsA receiving guselkumab every 4or8weeks (Q4W/Q8W) or placebo from DISCOVER-1 (31% tumor necrosis factor inhibitor-experienced) and DISCOVER-2 (biologic-naïve). Achievement of MCII in clinical Disease Activity Index for PsA (cDAPSA), patient global assessment (PtGA) of arthritis, PtGA of psoriasis, patient-reported pain, Functional Assessment of Chronic Illness Therapy-Fatigue, Health Assessment Questionnaire-Disability Index, 36-item Short-Form Health Survey Physical Component Summary score, PtGA Arthritis + Psoriasis, and PsA Disease Activity Score (PASDAS) was compared between the guselkumab and placebo groups using Cox regression. Logistic regression adjusting for baseline factors evaluated associations between early (W4/W8) MCII achievement and stringent response (≥%50/%70 improvement in American College of Rheumatology response criteria, cDAPSA low disease activity [LDA], PASDAS LDA, and minimal disease activity) at W24/W52 among guselkumab-randomized patients. Among patients with highly active PsA (baseline cDAPSA = 44.1-45.0, PASDAS = 6.4-6.5), times to MCII were significantly faster for guselkumab vs. placebo (hazard ratios 1.3-2.5; P < 0.05). Across measures, at first timepoint assessed, MCII rates were significantly higher with guselkumab (Q4W/Q8W 28-68%/29-65%) vs. placebo (19-47%; both P < 0.05). Early (W4/W8) MCII with guselkumab associated with higher odds of achieving stringent responses at W24/W52 (odds ratios 1.4-17.2/1.4-5.4). In a mixed PsA population, significant proportions of patients treated with guselkumab achieved early (W4/W8) MCII across clinical and PRO measures, which associated with ahigher likelihood of attaining clinically relevant improvements and low levels of disease activity at W24/W52. DISCOVER-1 (NCT03162796). DISCOVER-2 (NCT03158285).

Establishing minimal clinically important differences for the quality of life scale QLICD-SLE for patients with systemic lupus erythematosus based on ROC curve

The minimal clinically important difference (MCID) is an important concept with big appeal in a field struggling to interpret quality of life (QOL) and other patient-reported outcomes (PRO), is also a bridge between statistics and clinical medicine. This study uses the ROC curve to formulate the MCID value of the Quality of Life Instruments for Chronic Diseases of Systemic lupus erythematosus (QLICD-SLE V2.0) scale. Using the representative item “In general, would you say your health is” of the MOS item short form health survey(SF-36) as an anchor, the questionnaire of QLICD-SLE V2.0 and the anchor item were used to investigate the patients on the first day of hospitalization, and the day before the patient was discharged. 279 patients with lupus erythematosus were participated in this longitudinal follow-up study. The ROC curve was constructed by using the classification based on the anchor item as the gold standard and the difference score of the scale as the test variable. The cut-off point corresponding to the maximum value of the Youden index in the ROC curve is taken as the minimum clinical importance difference (MCID) value of the QLICD-SLE (V2.0) scale. The Results showed that the MCID of physical domain, psychological domain, social domain, general module, specific module and QLICD-SLE (V2.0) total scale are 8.3, 2.3, 2.5, 2.7, 9.2 and 3.2, respectively. Area under the ROC curve of QLICD-SLE (V2.0) is 0.898, P (Area = 0.5) < 0.001, the sensitivity is 100%, the specificity is 66.9%. It concluded that if the total scores after treatments changes at least 3.2 points positively, the treatment intervention can be considered as clinically significant. It is more convincing to use the corresponding cut-off point as the MCID for ROC curve method can visualize the sensitivity and specificity.

Health service utilization, economic burden and quality of life of patients with mucopolysaccharidosis in China

BackgroundPatients with mucopolysaccharidosis (MPS) often face delayed diagnoses, limited treatment options and high healthcare costs, that may significantly affect patients' quality of life. The objective of this study was to understand medical service utilization related to diagnosis and treatment, economic burden during diagnosis period, and health-related quality of life among MPS patients in China.MethodsA series of patients diagnosed with MPS registered in the national patient organization were recruited for a cross-sectional survey from May to July 2019. Information were collected from patients or their parents via phone interview, including demographic data, utilization of services related to diagnosis and treatment, total cost during the period of MPS diagnosis and health-related quality of life (HRQoL). HRQoL was assessed by PedsQL 4.0 Generic Core Scale (PedsQL) and 36-item short-form health survey (SF-36) depending on the age of patients with MPS and compared with the general Chinese population.ResultsA total of 180 MPS patients (50, 67, 15, 46, 1 and 1 for type I, II, III, IV, VI and VII), with a mean age of 9.54 years and 137 (76.11%) males, were included in analysis. The mean age at first visit to a medical doctor for MPS related symptoms was 3.65 ± 2.58 years old, while only 12 patients (6.67%) were diagnosed on their first visit. The mean diagnostic delay, which is defined as the time between the first visit to a medical doctor for MPS related symptoms and the final diagnosis, was 9.42 months, with no significant difference between types. The average number of misdiagnosis was 4.56. Before the confirmed diagnosis, the patients made an average of 6.31 visits and visited 4.3 hospitals. During diagnosis period, the mean of ¥81,086.72 direct medical costs accounted for 63.75% of the total cost. Only 32.78% of the patients had ever received specific treatments. The mean scores of PedsQL and SF-36 of patients were significantly lower than the Chinese norms. Household annual income per person, specific treatment use and MPS subtype were significantly associated HRQoL of patients.ConclusionThe results highlight challenges faced by MPS patients in terms of diagnosis, access to specific treatments, economic burden and low HRQoL. There is an urgent need to improve early detection and diagnosis, create fair and consistent mechanisms to increase access to specialized treatment and reduce the economic burden of MPS patients in China.

The association of acute and chronic phase cerebrovascular reactivity with patient reported quality of life following moderate-to-severe traumatic brain injury

Global outcomes have been reported to be associated with cerebrovascular reactivity (CVR) in the acute phase following moderate and severe traumatic brain injury (TBI). The association of CVR in the acute and chronic phase of injury with patient-reported health-related quality of life metrics (HRQOL) metrics has never been explored. The aim of this study is to examine the association of CVR, as measured by the cerebral oxygen indices (COx and COx_a), in the acute and chronic phase following moderate and severe TBI, with patient reported HRQOL. In this prospective cohort study, performed in a Canadian quaternary care center, the association between continuous acute and chronic phase CVR with patient reported HRQOL outcomes following moderate and severe TBI was examined. The main outcomes of interest of this study were validated measures of patient-reported HRQOL over various domains as measured by both the 12-Item Short-Form Health Survey (SF-12) and a Quality of Life after Brain Injury (QOLIBRI) questionnaire. In the 29 subjects of this cohort, acute phase CVR was found to be significantly more active in those with a favorable Mental Component Summary (MCS) scores of the SF-12 at early follow-up when measured by COx (-0.015 [IQR: -0.067 to 0.032] vs 0.040 [IQR: 0.019 to 0.137] for Favorable first MCS vs Unfavorable respectively; Mann–Whitney U test p-value = 0.046) and COx_a (0.038 [IQR: 0.009 to 0.062] vs 0.112 [IQR: 0.065 to 0.167] for Favorable first MCS vs Unfavorable respectively; Mann–Whitney U test p-value = 0.014). Further, multivariable logistic regression analysis found acute phase COx and COx_a to improve model performance when predicting favorable versus unfavorable early MCS scores over established parameters such as age and measures of injury severity. Associations between outcomes and chronic phase CVR were limited, potentially due to short recording periods. This is the first ever pilot study to identify a relationship between acute phase CVR following moderate-to-severe TBI with mental and cognitive outcomes as experienced by patients. Given the small cohort, these findings will need to be confirmed in a larger multicenter study. This highlights the need for additional examination of the role dysfunctional CVR may play in mental and cognitive outcomes, as well as patient-reported outcomes more generally following TBI.

Higher energy delivery is associated with improved long-term survival among adults with major burn injury: A multicenter, multinational, observational study.

Numerous feeding strategies have been used to mitigate the catabolism of major burn injury. Whether higher energy and/or protein delivery results in better long-term outcomes is unknown. We performed a secondary analysis of data from adults with major burn injuries enrolled in the Randomized Trial of Enteral Glutamine to Minimize the Effects of Burn Injury at 54 burn centers in 18 countries. The sample was restricted to those who were mechanically ventilated within 72 hours of injury and for ≥7 days. Our key exposure was adequacy of energy, and protein ([Deliveredi/Prescribedi] × 100) was categorized into three groups each: low, 0% to 50%; moderate, ≥50% to 79%; and high, ≥80%. We also analyzed adequacy using restricted cubic splines. Primary and secondary outcomes included 6-month mortality and functional outcomes (i.e., 36-Item Short-Form Health Survey, Katz Index of Independence in Activities of Daily Living, Lawton Activities of Daily Living scores), respectively. Regression models were adjusted for age, body mass index, Charlson Comorbidity Index, baseline Acute Physiology and Chronic Health Evaluation II and modified Sequential Organ Failure Assessment scores, burn size, energy/protein adequacy, and study site. A total of 493 participants met the cohort restriction criteria; 336 participants were alive at 6 months. 36-Item Short-Form Health Survey, Katz Index of Independence in Activities of Daily Living, and Lawton Instrumental Activities of Daily Living Scale were completed by 218, 216, and 215 participants, respectively. The mean ± SD age was 48 ± 17 years, and 74% were male. The mean ± SD burn size was 41% ± 18% total body surface area. Participants who received 25% of recommended calories had nearly four times the hazard of death during the 6-month follow-up period than participants who received 100% of prescribed calories (adjusted hazard ratio, 3.89; 95% confidence interval, 1.35-11.20) (p = 0.02). There was no significant association between protein and 6-month mortality or energy/protein delivery and 6-month functional outcomes. There was a positive association between higher doses of energy and 6-month survival. This relationship conflicts somewhat with several energy studies among critically ill and non-burn-injured patients. The lack of consistent evidence on optimal nutrition for critically injured patients, a fundamental component of burn care, suggests potential for a randomized trial of lower versus higher energy to improve long-term outcomes after burn injury. Therapeutic/Care Management; Level III.

The SAInT study: a protocol for a randomized controlled trial of steroid injection for subacromial pain syndrome using the anterolateral versus posterior approach.

Steroid injections are used for subacromial pain syndrome and can be administered via the anterolateral or posterior approach to the subacromial space. It is not currently known which approach is superior in terms of improving clinical symptoms and function. This is the protocol for a randomized controlled trial (RCT) to compare the clinical effectiveness of a steroid injection given via the anterolateral or the posterior approach to the subacromial space. The Subacromial Approach Injection Trial (SAInT) study is a single-centre, parallel, two-arm RCT. Participants will be allocated on a 1:1 basis to a subacromial steroid injection via either the anterolateral or the posterior approach to the subacromial space. Participants in both trial arms will then receive physiotherapy as standard of care for subacromial pain syndrome. The primary analysis will compare the change in Oxford Shoulder Score (OSS) at three months after injection. Secondary outcomes include the change in OSS at six and 12 months, as well as the Pain Numeric Rating Scale (0 = no pain, 10 = worst pain), Disabilities of Arm, Shoulder and Hand questionnaire (DASH), and 36-Item Short-Form Health Survey (SF-36) (RAND) at three months, six months, and one year after injection. Assessment of pain experienced during the injection will also be determined. A minimum of 86 patients will be recruited to obtain an 80% power to detect a minimally important difference of six points on the OSS change between the groups at three months after injection. The results of this trial will demonstrate if there is a difference in shoulder pain and function after a subacromial space steroid injection between the anterolateral versus posterior approach in patients with subacromial pain syndrome. This will help to guide treatment for patients with subacromial pain syndrome.

A biopsychosocial questionnaire for patients with primer Sjögren's syndrome: The BETY-Biopsychosocial Questionnaire.

The BETY-Biopsychosocial Questionnaire (BETY-BQ) is a scale developed to assess the biopsychosocial domains of patients with rheumatic diseases under a single roof. The study aimed to determine the validity and reliability of the BETY-BQ in patients with primary Sjögren's Syndrome (pSS). At enrollment and one week, 91 patients with pSS completed the BETY-BQ. Construct validity was measured by correlating the BETY-BQ total score responses with the Health Assessment Questionnaire (HAQ), Hospital Anxiety and Depression Scale (HADS), 36-Item Short-Form Health Survey (SF-36), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), Primary Sjögren's Syndrome Quality of Life questionnaire (PSS-QoL), and Euro-QoL 5D (EQ-5D). The BETY-BQ correlated high to moderate with HAQ, bodily pain subscale of SF-36, Euro Qol-5D, PSS-QoL, HADS, and ESSPRI (0.776 to 0.557, p <0.05). Spearman's correlation coefficients between BETY-BQ total scores at baseline and average one week were very high (rho = 0.98, <0.001) and indicated substantial agreement between test-retest scores (ICC = 0.99, <0.001). Internal consistency reliability at baseline was 0.91 for the BETY-BQ. BETY-BQ is valid and reliable for assessing biopsychosocial status in patients with pSS and can be used to measure outcomes in pSS.

Cross-Cultural Adaptation and Psychometric Evaluation of the Brazilian Portuguese Version of the Nocturia Quality-of-Life Questionnaire.

The objective was to cross-culturally adapt and check for the reliability, internal consistency, and validity of the Nocturia Quality of Life Questionnaire (N-QoL) in Brazilian Portuguese (N-QoL-Br). The questionnaire was translated according to international guidelines, included forward-translation, back-translation, and consensus among an expert committee. Participants with nocturia completed the Pittsburgh Sleep Quality Index, International Consultation on Incontinence Questionnaire Overactive Bladder, and the General Quality of Life Assessment Questionnaire SF-36 (Medical Outcomes Study 36-Item Short-Form Health Survey), in addition to the N-QoL-Br. The Brazilian version was applied in men and women with nocturia twice within a range of 4weeks. Psychometric properties such as content validity, construct validity, internal consistency, and test-retest reliability were tested. Content validity was considered adequate. Eighty-four men and women participated in the study. Good internal consistency in the domains and final score of the N-QoL-Br was observed, with Cronbach α greater than 0.9. The test-retest reliability was also high, with an intraclass correlation coefficient greater than 0.9 for the domain sleep/energy, bother/concern, and total score (0.98, 0.98, and 0.97 respectively). The Portuguese version of the N-QoL-Br presents good internal consistency and reproducibility and it can be considered adequate and valid for evaluating the impact of nocturia on the quality of life of men and women in the Brazilian population.

A Study to Evaluate the Effect of Alpha-Lipoic Acid on Neuropathic Symptoms in Diabetic Neuropathy Patients on Gabapentin or Pregabalin.

Introduction Chronic hyperglycemia is a key factor in the development of diabetic peripheral neuropathy (DPN), contributing significantly to the progression of this condition through the induction of oxidative stress. Elevated blood glucose levels lead to increased production of reactive oxygen species (ROS), which cause damage to neuronal cells and exacerbate neuropathic symptoms. Alpha-lipoic acid (ALA) is a potent antioxidant that neutralizes ROS and reduces oxidative damage. By addressing the mechanisms of neuropathy, ALA mitigates the effects of chronic hyperglycemia through antioxidant regeneration, inflammation reduction, and endothelial function improvement. As a result, ALA is emerging as a promising intervention for managing oxidative stress and inflammation in DPN. Methods Prospective, double-blind, placebo-controlled study, a total of 52 DPN subjects on gabapentin or pregabalin were randomly assigned to either ALA 600 mg oral once daily or placebo oral once daily for 12 weeks. Treatment outcome was assessed using vibration perception threshold (VPT), Neuropathy Total Symptom Score 6 (NTSS-6), quality of life (QOL) assessed by 12-Item Short Form Health Survey (SF-12) Questionnaire, oxidative stress biomarkers (malondialdehyde (MDA), nitric oxide (NO), and glutathione (GSH)) and inflammatory biomarker (high-sensitivity C-reactive protein (hs-CRP)) at baseline and every visit (four, eight, and 12 weeks). Neuron-specific enolase (NSE) levels were done at baseline and 12 weeks. Glycated hemoglobin (HbA1C) and safety parameters were done at screening and 12 weeks. Compliance with the study medication was assessed by pill count. Reported adverse drug reactions were recorded. Results A total of 52 subjects (males = 22; females = 30) with a mean age of 55.63 ± 7.5 years were randomized to receive either ALA or placebo. A significant reduction in VPT was observed with ALA at 12 weeks compared to baseline (from 26.92 ± 3.58 to 22.14 ± 1.94; p < 0.0001). Secondary parameters like NTSS-6, QOL by SF-12 questionnaire, NSE levels, oxidative biomarkers levels, and inflammatory biomarkers showed significant improvement with ALA compared to placebo. No serious adverse events were reported. Conclusion ALA demonstrated a protective effect against DPN by its antioxidant and anti-inflammatory effects and was found to have good safety.

Multicentre investigation on the effect of decompressive surgery on Balance and physical ActiviTy Levels amongst patients with lumbar Spinal stenosis (B-ATLAS): protocol for a prospective cohort study

IntroductionPatients with lumbar spinal stenosis may have poor balance, decreased physical function and problems maintaining physical activity levels due to radiculopathy. Decompressive surgery is often indicated if conservative management fails...

Long-term outcomes of mechanochemical ablation using the Clarivein device for the treatment of great saphenous vein incompetence

ObjectiveThe short-term anatomical success rates of mechanochemical ablation using the Clarivein device (Merit Medical) in the treatment of great saphenous vein (GSV) incompetence are high. However, the anatomical success rates seem to drop over time. The aim of this study was to determine the long-term outcomes of GSV treatment using the Clarivein and to assess whether specific anatomical features better correlate with clinical or quality of life (QoL)-related outcomes. MethodsThis is a single-center, prospective cohort study in follow-up of a multicenter, randomized controlled trial using Clarivein with liquid polidocanol for the treatment of GSV incompetence. The primary outcome was anatomical success (AS), defined as complete occlusion or a recanalized segment, irrespective of reflux, of <10 cm in length. In addition, reflux-free anatomical success (RF-AS) was determined, and defined as complete occlusion or a recanalized segment with <10 cm of reflux. Clinical success was assessed using the Venous Clinical Severity Score (VCSS), and QoL was assessed using the Dutch version of the Aberdeen Varicose Vein Questionnaire (DAVVQ) and the 36-Item Short Form Health Survey (SF-36). Subgroup analyses were performed based on whether AS or RF-AS was achieved or not. ResultsA total of 109 patients (115 limbs) were included. The mean follow-up time was 8.4 ± 0.9 years (range, 5.5-10.3 years). AS was seen in 60.5% of limbs, and RF-AS was seen in 72.8% of limbs. Compared with baseline, the overall mean VCSS improved from 5.3 ± 2.4 to 4.1 ± 2.4, and the overall median DAVVQ score from 13.5 (interquartile range [IQR], 8.7-20.0) to 10.5 (IQR, 5.3-16.2) (P < .001). Improvement in VCSS was only significant in patients with successful treatment: from 5.5 ± 2.7 to 3.7 ± 2.5 (P < .001) if AS was achieved and from 5.0 ± 1.7 to 4.5 ± 1.9 (P = .20) if AS was not achieved. The same results were found for DAVVQ scores: improvement from13.5 (IQR, 8.7-20.6) to 10.3 (IQR, 3.0-14.5) (P < .01) if AS was achieved and from 12.9 (IQR, 8.3-19.3) to 10.8 (IQR, 6.7-18.2) (P = .35) if AS was not achieved. Regarding the overall SF-36 scores, the domains of vitality, mental health, and general health worsened significantly. ConclusionsIn over 8 years of follow-up, the anatomical success rate after the treatment of GSV incompetence using the Clarivein device decreased to 60.5%. However, clinical scores and disease-specific QoL still improved significantly compared with baseline. We found no convincing evidence that the absence of reflux correlates better with clinical and QoL-related outcomes compared with recanalization irrespective of reflux.