Association of systemic lupus erythematosus standard of care immunosuppressants with glucocorticoid use and disease outcomes: a multicentre cohort study.

BACKGROUND: This study examines the association of standard-of-care systemic lupus erythematosus (SLE) medications with key outcomes such as low disease activity attainment, flares, damage accrual, and steroid-sparing, for which there is current paucity of data. METHODS: The Asia Pacific Lupus Collaboration (APLC) prospectively collects data across numerous sites regarding demographic and disease characteristics, medication use, and lupus outcomes. Using propensity score methods and panel logistic regression models, we determined the association between lupus medications and outcomes. RESULTS: Among 1707 patients followed over 12,689 visits for a median of 2.19 years, 1332 (78.03%) patients achieved the Lupus Low Disease Activity State (LLDAS), 976 (57.18%) experienced flares, and on most visits patients were taking an anti-malarial (69.86%) or immunosuppressive drug (76.37%). Prednisolone, hydroxychloroquine and azathioprine were utilised with similar frequency across all organ domains; methotrexate for musculoskeletal activity. There were differences in medication utilisation between countries, with hydroxychloroquine less frequently, and calcineurin inhibitors more frequently, used in Japan. More patients taking leflunomide, methotrexate, chloroquine/hydroxychloroquine, azathioprine, and mycophenolate mofetil/mycophenolic acid were taking ≤ 7.5 mg/day of prednisolone (compared to > 7.5 mg/day) suggesting a steroid-sparing effect. Patients taking tacrolimus were more likely (Odds Ratio [95% Confidence Interval] 13.58 [2.23-82.78], p = 0.005) to attain LLDAS. Patients taking azathioprine (OR 0.67 [0.53-0.86], p = 0.001) and methotrexate (OR 0.68 [0.47-0.98], p = 0.038) were less likely to attain LLDAS. Patients taking mycophenolate mofetil were less likely to experience a flare (OR 0.79 [0.64-0.97], p = 0.025). None of the drugs was associated with a reduction in damage accrual. CONCLUSIONS: This study suggests a steroid-sparing benefit for most commonly used standard of care immunosuppressants used in SLE treatment, some of which were associated with an increased likelihood of attaining LLDAS, or reduced incidence of flares. It also highlights the unmet need for effective treatments in lupus.

Endothelial Protein C Receptor and Its Impact on Rheumatic Disease.

Endothelial Protein C Receptor (EPCR) is a key regulator of the activated protein C anti-coagulation pathway due to its role in the binding and activation of this protein. EPCR also binds to other ligands such as Factor VII and X, γδ T-cells, plasmodium falciparum erythrocyte membrane protein 1, and Secretory group V Phospholipases A2, facilitating ligand-specific functions. The functions of EPCR can also be regulated by soluble (s)EPCR that competes for the binding sites of membrane-bound (m)EPCR. sEPCR is created when mEPCR is shed from the cell surface. The propensity of shedding alters depending on the genetic haplotype of the EPCR gene that an individual may possess. EPCR plays an active role in normal homeostasis, anti-coagulation pathways, inflammation, and cell stemness. Due to these properties, EPCR is considered a potential effector/mediator of inflammatory diseases. Rheumatic diseases such as rheumatoid arthritis and systemic lupus erythematosus are autoimmune/inflammatory conditions that are associated with elevated EPCR levels and disease activity, potentially driven by EPCR. This review highlights the functions of EPCR and its contribution to rheumatic diseases.

It's OK to move! Effect of a brief video on community confidence in activity despite back pain: A randomised trial.

OBJECTIVE: To estimate the difference in confidence to become active despite low back pain in people who were exposed to one of two video interventions delivered on social media, compared to no intervention. DESIGN: A proof of concept three group randomised controlled trial, in a 1:1:1 ratio. METHODS: Participants aged 18 years and over, with and without low back pain, were recruited via the social media channel Facebook, to view either a humorous video, a neutral video or to no intervention. The videos were delivered online, explained evidence-based management for low back pain, and were designed to "go viral". The primary outcome was confidence in becoming active despite pain, measured using the Pain Self Efficacy Questionnaire(Item 10) [range from 0 (not at all confident) to 6 (completely confident)] immediately after watching the video. We aimed to capture the real-time impact and immediate reactions that contributed to the content's reach. RESULTS: Among 1933 randomized participants (mean [SD] age 58.9 [14.0] years, 1285 [75%] women) 1232 [70%] had low back pain and 88.8% completed the primary outcome. 1264 participants were randomised to receive a video intervention, and 633 participants did not receive a video. On a 6-point scale, individuals exposed to either video (n=1088) showed a mean confidence level 0.3 points higher (95% CI 0.1 to 0.6) compared with no video (n=630). CONCLUSION: Participants who viewed a brief video intervention reported a very small difference in confidence to become active despite low back pain, compared with no intervention. The difference may lack clinical relevance.

Comparison of Attainment and Protective Effects of Lupus Low Disease Activity State In Patients With Newly Diagnosed Versus Established Systemic Lupus Erythematosus.

OBJECTIVE: To assess whether Lupus Low Disease Activity State (LLDAS) attainment is associated with favorable outcomes in patients with recent onset systemic lupus erythematosus (SLE). METHODS: Data from a 13-country longitudinal SLE cohort were collected prospectively between 2013 and 2020. An inception cohort was defined based on disease duration < 1 year at enrollment. Patient characteristics between inception and noninception cohorts were compared. Survival analyses were performed to examine the association between LLDAS attainment and damage accrual and flare. RESULTS: Of the total 4106 patients, 680 (16.6%) were recruited within 1 year of SLE diagnosis (inception cohort). Compared to the noninception cohort, inception cohort patients were significantly younger, had higher disease activity, and used more glucocorticoids, but had less organ damage at enrollment. Significantly fewer inception cohort patients were in LLDAS at enrollment than the noninception cohort (29.6% vs 52.3%, P < 0.001), but three-quarters of both groups achieved LLDAS at least once during follow-up. Limiting analysis only to patients not in LLDAS at enrollment, inception cohort patients were 60% more likely to attain LLDAS (hazard ratio 1.37, 95% CI 1.16-1.61, P < 0.001) than noninception cohort patients and attained LLDAS significantly faster. LLDAS attainment was significantly protective against flare in both the inception and noninception cohorts. A total of 88 (13.6%) inception cohort patients accrued organ damage during a median 2.2 years of follow-up. CONCLUSION: LLDAS attainment is protective from flare in recent onset SLE. Significant protection from damage accrual was not observed because of low rates of damage accrual in the first years after SLE diagnosis. (ClinicalTrials.gov: NCT03138941).

Exploring the Use of the Picture Exchange Communication System (PECS) in Special Education Settings.

The Picture Exchange Communication System (PECS) is an Augmentative and Alternative Communication (AAC) system which is widely used to support children with developmental disabilities. In the present study, we surveyed individuals responsible for implementing PECS in special educational settings in the United Kingdom (N=283). We explored knowledge of and adherence to the  intervention, with a view to identifying training and support needs. Specifically, we examined participants' knowledge, implementation accuracy, training experiences, access to resources, and attitudes towards PECS. We developed hierarchical logistic regression models to explore the association between training experience and both knowledge and use of PECS. We pre-registered our methods, predictions and the analysis plan on the Open Science Framework (OSF).We found considerable variation in practitioner knowledge and implementation of PECS. Formal training predicted greater knowledge and more accurate implementation when practitioner role and the degree of setting support were accounted for. While PECS was rated by a large majority to be effective and practical, many participants identified that time and the availability of resources were barriers to implementation. We also found that the purpose of PECS was not always fully understood by practitioners, and we identified some consistent gaps in knowledge and implementation.  This study contributes new information regarding the real-world  use of PECS in educational settings and offers new insights for supporting practitioners.

Risk of flare and damage accrual after tapering glucocorticoids in modified serologically active clinically quiescent patients with systemic lupus erythematosus: a multinational observational cohort study.

OBJECTIVES: To assess the risk of flare and damage accrual after tapering glucocorticoids (GCs) in modified serologically active clinically quiescent (mSACQ) patients with systemic lupus erythematosus (SLE). METHODS: Data from a 12-country longitudinal SLE cohort, collected prospectively between 2013 and 2020, were analysed. SLE patients with mSACQ defined as the state with serological activity (increased anti-dsDNA and/or hypocomplementemia) but without clinical activity, treated with ≤7.5 mg/day of prednisolone-equivalent GCs and not-considering duration, were studied. The risk of subsequent flare or damage accrual per 1 mg decrease of prednisolone was assessed using Cox proportional hazard models while adjusting for confounders. Observation periods were 2 years and censored if each event occurred. RESULTS: Data from 1850 mSACQ patients were analysed: 742, 271 and 180 patients experienced overall flare, severe flare and damage accrual, respectively. Tapering GCs by 1 mg/day of prednisolone was not associated with increased risk of overall or severe flare: adjusted HRs 1.02 (95% CI, 0.99 to 1.05) and 0.98 (95% CI, 0.96 to 1.004), respectively. Antimalarial use was associated with decreased flare risk. Tapering GCs was associated with decreased risk of damage accrual (adjusted HR 0.96, 95% CI, 0.93 to 0.99) in the patients whose initial prednisolone dosages were >5 mg/day. CONCLUSIONS: In mSACQ patients, tapering GCs was not associated with increased flare risk. Antimalarial use was associated with decreased flare risk. Tapering GCs protected mSACQ patients treated with >5 mg/day of prednisolone against damage accrual. These findings suggest that cautious GC tapering is feasible and can reduce GC use in mSACQ patients.

SMART-SLE: serology monitoring and repeat testing in systemic lupus erythematosus-an analysis of anti-double-stranded DNA monitoring.

OBJECTIVE: Disease activity monitoring in SLE includes serial measurement of anti-double stranded-DNA (dsDNA) antibodies, but in patients who are persistently anti-dsDNA positive, the utility of repeated measurement is unclear. We investigated the usefulness of serial anti-dsDNA testing in predicting flare in SLE patients who are persistently anti-dsDNA positive. METHODS: Data were analysed from patients in a multinational longitudinal cohort with known anti-dsDNA results from 2013 to 2021. Patients were categorized based on their anti-dsDNA results as persistently negative, fluctuating or persistently positive. Cox regression models were used to examine longitudinal associations of anti-dsDNA results with flare. RESULTS: Data from 37 582 visits of 3484 patients were analysed. Of the patients 1029 (29.5%) had persistently positive anti-dsDNA and 1195 (34.3%) had fluctuating results. Anti-dsDNA expressed as a ratio to the normal cut-off was associated with the risk of subsequent flare, including in the persistently positive cohort (adjusted hazard ratio [HR] 1.56; 95% CI: 1.30, 1.87; P < 0.001) and fluctuating cohort (adjusted HR 1.46; 95% CI: 1.28, 1.66), both for a ratio >3. Both increases and decreases in anti-dsDNA more than 2-fold compared with the previous visit were associated with increased risk of flare in the fluctuating cohort (adjusted HR 1.33; 95% CI: 1.08, 1.65; P = 0.008) and the persistently positive cohort (adjusted HR 1.36; 95% CI: 1.08, 1.71; P = 0.009). CONCLUSION: Absolute value and change in anti-dsDNA titres predict flares, including in persistently anti-dsDNA positive patients. This indicates that repeat monitoring of dsDNA has value in routine testing.

Using off-the-shelf solutions as assistive technology to support the self-management of academic tasks for autistic university students.

Having the skills to self-manage the demands of academic life in third-level education is critical to the successful completion of courses taken there. Independent study behavior is an aspect of university life that pervades all topics but one that requires the self-management of time in relation to study goals. Individuals with additional educational needs, such as autism, often have difficulty self-managing independent study. This may result in students failing to meet the standards required for successful course completion. The current study (n = 2) used a range bound changing criterion design to evaluate the effects of a behavioral intervention that included assistive technology in the form of a smartphone and wearable smartwatch. The intervention aimed to increase the duration of independent study behavior among university students with autism. The intervention combined self-management (goal setting, self-monitoring, self-recording) together with assistive tech. to prompt engagement in, and recording of, independent study behavior. Findings showed the intervention to be effective at increasing independent study duration for autistic adults attending third-level education.

Use of statewide financial incentives to improve documentation of hernia and mesh characteristics in ventral hernia repair.

BACKGROUND: Documentation of intraoperative details is critical for understanding and advancing hernia care, but is inconsistent in practice. Therefore, to improve data capture on a statewide level, we implemented a financial incentive targeting documentation of hernia defect size and mesh use. METHODS: The Abdominal Hernia Care Pathway (AHCP), a voluntary pay for performance (P4P) initiative, was introduced in 2021 within the statewide Michigan Surgical Quality Collaborative (MSQC). This consisted of an organizational-level financial incentive for achieving 80% performance on eight specific process measures for ventral hernia surgery, including complete documentation of hernia defect size and location, as well as mesh characteristics and fixation technique. Comparisons were made between AHCP and non-AHCP sites in 2021. RESULTS: Of 69 eligible sites, 47 participated in the AHCP in 2021. There were N = 5362 operations (4169 at AHCP sites; 1193 at non-AHCP sites). At AHCP sites, 69.8% of operations had complete hernia documentation, compared to 50.5% at non-AHCP sites (p < 0.0001). At AHCP sites, 91.4% of operations had complete mesh documentation, compared to 86.5% at non-AHCP sites (p < 0.0001). The site-level hernia documentation goal of 80% was reached by 14 of 47 sites (range 14-100%). The mesh documentation goal was reached by 41 of 47 sites (range 4-100%). CONCLUSIONS: Addition of an organizational-level financial incentive produced marked gains in documentation of intra-operative details across a statewide surgical collaborative. The relatively large effect size-19.3% for hernia-is remarkable among P4P initiatives. This result may have been facilitated by surgeons' direct role in documenting hernia size and mesh use. These improvements in data capture will foster understanding of current hernia practices on a large scale and may serve as a model for improvement in collaboratives nationally.

Comparison of Titanium Dioxide and Zinc Oxide Photocatalysts for the Inactivation of Escherichia coli in Water Using Slurry and Rotating-Disk Photocatalytic Reactors.

The application of photocatalysis for the disinfection of water has been extensively reported over the past 30 years. Titanium dioxide (TiO2) has been the most widely and successfully used photocatalyst to date; however, it is not without its limitations. Frequently observed long lag times, sometimes up to 60 min, before bacterial inactivation begins and the presence of residual microorganisms, for example, up to 104 colony forming units, remaining after treatment are ongoing challenges with this particular photocatalyst. It is therefore important to find alternative photocatalysts that can address these issues. In this study, we compared the disinfection capacity of TiO2 with that of zinc oxide (ZnO) using Escherichia coli as a model organism in both a suspended and immobilized catalyst system. Our results showed that ZnO was superior to TiO2 in a number of areas. Not only were bacterial rates of destruction much quicker with ZnO, but no lag time was observed prior to inactivation in suspended systems. Furthermore, complete bacterial destruction was observed within the treatment times under investigation. The greater efficiency of ZnO is believed to be due to the decomposition of the bacterial cell wall being driven by hydrogen peroxide as opposed to hydroxyl radicals. The results reported in this paper show that ZnO is a more efficient and cost-effective photocatalyst than TiO2 and that it represents a viable alternative photocatalyst for water disinfection processes.

Mesh overlap for ventral hernia repair in current practice.

INTRODUCTION: Sufficient overlap of mesh beyond the borders of a ventral hernia helps prevent hernia recurrence. Guidelines from the European Hernia Society and American Hernia Society recommend ≥ 2 cm overlap for open repair of < 1-cm hernias, ≥ 3-cm overlap for open repair of 1-4-cm hernias, ≥ 5-cm overlap for open repair of > 4-cm hernias, and ≥ 5-cm overlap for all laparoscopic ventral hernia repairs. We evaluated whether current practice reflects this guidance. METHODS: We used the Michigan Surgical Quality Collaborative Hernia Registry to evaluate patients who underwent elective ventral and umbilical hernia repair between 2020 and 2022. Mesh overlap was calculated as [(width of mesh - width of hernia)/2]. The main outcome was "sufficient overlap," defined based on published EHS and AHS guidelines. Explanatory variables included patient, operative, and hernia characteristics. The main analysis was a multivariable logistic regression to evaluate the association between explanatory variables and sufficient mesh overlap. RESULTS: 4178 patients underwent ventral hernia repair with a mean age of 55.2 (13.9) years, 1739 (41.6%) females, mean body mass index (BMI) of 33.1 (7.2) kg/m2, and mean hernia width of 3.7 (3.4) cm. Mean mesh overlap was 3.7 (2.5) cm and ranged from - 5.5 to 21.4 cm. Only 1074 (25.7%) ventral hernia repairs had sufficient mesh overlap according to published guidelines. Operative factors associated with increased odds of sufficient overlap included myofascial release (adjusted odds ratio [aOR] 5.35 [95% CI 4.07-7.03]), minimally invasive approach (aOR 1.86 [95% CI 1.60-2.17]), and onlay mesh location (aOR 1.31 [95% CI 1.07-1.59]). Patient factors associated with increased odds of sufficient overlap included prior hernia repair (aOR 1.59 [95% CI 1.32-1.92]). CONCLUSION: Although sufficient mesh overlap is recommended to prevent ventral hernia recurrence, only a quarter of ventral hernia repairs in a state-wide cohort of patients had sufficient overlap according to evidence-based guidelines. Factors strongly associated with sufficient overlap included myofascial release, mesh type, and laparoscopic repair.

Mid-term Outcomes of Nissen Fundoplication Versus Roux-en-y Gastric Bypass for Primary Management of Gastroesophageal Reflux Disease in Patients With Obesity.

INTRODUCTION: The efficacy and outcomes of laparoscopic Nissen fundoplication (LNF) in patients with obesity is controversial. Specifically, concerns regarding long-term outcomes and recurrence in the setting of obesity has led to interest in laparoscopic Roux-en-Y gastric bypass (RYGB). METHODS: In this retrospective cohort study, we studied patients with obesity who underwent either LNF or RYGB for gastroesophageal reflux disease. Baseline demographics, clinical variables, operative outcomes, and symptom severity scores were compared. RESULTS: Baseline demographics, operative outcomes, and quality-of-life scores were similar. Proton pump inhibitor usage, quality-of-life, symptom severity scores, and satisfaction with the operation were similar between groups at mid-term follow-up. DISCUSSION: RYGB and LNF produced similar improvements in disease-specific quality of life with similar rates of complications, side effects, and need for reoperation. This demonstrates that RYGB and LNF represent possible options for surgical management of gastroesophageal reflux disease in obese patients.

Comparison of safety and healthcare utilization following sleeve gastrectomy or gastric bypass among medicare beneficiaries using sex as a biologic variable.

BACKGROUND: Bariatric surgery is a common operation, but differences in outcomes between males and females are unknown. OBJECTIVES: To compare the risk of mortality, complications, reintervention, and healthcare utilization after sleeve gastrectomy or gastric bypass using sex as a biologic variable. SETTING: United States. METHODS: Retrospective cohort study of adults undergoing sleeve gastrectomy or gastric bypass from January 1, 2012 to December 31, 2018 using Medicare claims data. We performed a heterogeneity of treatment effect analysis to determine the impact of sleeve gastrectomy versus gastric bypass comparing males to females. The primary outcome was safety (mortality, complications, and reinterventions) up to 5 years after surgery. The secondary outcome was healthcare utilization (hospitalization and emergency department use). RESULTS: Among 95,405 patients the majority (n = 71,348; 74.8%) were female and most (n = 57,008; 59.8%) underwent sleeve gastrectomy. For all patients, compared to gastric bypass, sleeve gastrectomy was associated with a lower risk of complications and reintervention but a higher risk of revision. Compared to gastric bypass, sleeve gastrectomy was associated with a lower risk of mortality for females (adjusted hazard ratio .86, 95% CI .75-.96) but not males. We found no difference in procedure treatment effect by sex for mortality, hospitalization, emergency department use, or overall reintervention when comparing sleeve to gastric bypass. CONCLUSIONS: Females and males have similar outcomes following bariatric surgery. Females have a lower risk of complications but a higher risk of reintervention. Decisions surrounding treatment for this common procedure should be tailored to include a discussion of sex-specific differences in treatment outcome.

Australian recommendations on perioperative use of disease-modifying anti-rheumatic drugs in people with inflammatory arthritis undergoing elective surgery.

Disease-modifying anti-rheumatic drugs (DMARDs) are effective treatments for inflammatory arthritis but carry an increased risk of infection. For patients undergoing surgery, there is a need to consider the trade-off between a theoretical increased risk of infection with continuation of DMARDs perioperatively versus an increased risk of disease flare if they are temporarily withheld. We used the Grading of Recommendations Assessment, Development and Evaluation methodology to develop recommendations for perioperative use of DMARDs for people with inflammatory arthritis undergoing elective surgery. The recommendations form part of the National Health and Medical Research Council-endorsed Australian Living Guideline for the Pharmacological Management of Inflammatory Arthritis. Conditional recommendations were made against routinely discontinuing conventional synthetic and biologic (b) DMARDs in the perioperative period but to consider temporary discontinuation of bDMARDs in individuals with a high risk of infection or where the impact of infection would be severe. A conditional recommendation was made in favour of temporary discontinuation of targeted synthetic DMARDs in the perioperative period.

Exercise as adjunctive therapy for systemic lupus erythematosus.

BACKGROUND: Systemic lupus erythematosus (SLE) is a rare, chronic autoimmune inflammatory disease with a prevalence varying from 4.3 to 150 people in 100,000, or approximately five million people worldwide. Systemic manifestations frequently include internal organ involvement, a characteristic malar rash on the face, pain in joints and muscles, and profound fatigue. Exercise is purported to be beneficial for people with SLE. For this review, we focused on studies that examined all types of structured exercise as an adjunctive therapy in the management of SLE. OBJECTIVES: To evaluate the benefits and harms of structured exercise as adjunctive therapy for adults with SLE compared with usual pharmacological care, usual pharmacological care plus placebo and usual pharmacological care plus non-pharmacological care. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 30 March 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of exercise as an adjunct to usual pharmacological treatment in SLE compared with placebo, usual pharmacological care alone and another non-pharmacological treatment. Major outcomes were fatigue, functional capacity, disease activity, quality of life, pain, serious adverse events, and withdrawals due to any reason, including any adverse events. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our major outcomes were 1. fatigue, 2. functional capacity, 3. disease activity, 4. quality of life, 5. pain, 6. serious adverse events, and 7. withdrawals due to any reason. Our minor outcomes were 8. responder rate, 9. aerobic fitness, 10. depression, and 11. anxiety. We used GRADE to assess certainty of evidence. The primary comparison was exercise compared with placebo. MAIN RESULTS: We included 13 studies (540 participants) in this review. Studies compared exercise as an adjunct to usual pharmacological care (antimalarials, immunosuppressants, and oral glucocorticoids) with usual pharmacological care plus placebo (one study); usual pharmacological care (six studies); and another non-pharmacological treatment such as relaxation therapy (seven studies). Most studies had selection bias, and all studies had performance and detection bias. We downgraded the evidence for all comparisons because of a high risk of bias and imprecision. Exercise plus usual pharmacological care versus placebo plus usual pharmacological care Evidence from a single small study (17 participants) that compared whole body vibration exercise to whole body placebo vibration exercise (vibrations switched off) indicated that exercise may have little to no effect on fatigue, functional capacity, and pain (low-certainty evidence). We are uncertain whether exercise results in fewer or more withdrawals (very low-certainty evidence). The study did not report disease activity, quality of life, and serious adverse events. The study measured fatigue using the self-reported Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue), scale 0 to 52; lower score means less fatigue. People who did not exercise rated their fatigue at 38 points and those who did exercise rated their fatigue at 33 points (mean difference (MD) 5 points lower, 95% confidence interval (CI) 13.29 lower to 3.29 higher). The study measured functional capacity using the self-reported 36-item Short Form health questionnaire (SF-36) Physical Function domain, scale 0 to 100; higher score means better function. People who did not exercise rated their functional capacity at 70 points and those who did exercise rated their functional capacity at 67.5 points (MD 2.5 points lower, 95% CI 23.78 lower to 18.78 higher). The study measured pain using the SF-36 Pain domain, scale 0 to 100; lower scores mean less pain. People who did not exercise rated their pain at 43 points and those who did exercise rated their pain at 34 points (MD 9 points lower, 95% CI 28.88 lower to 10.88 higher). More participants from the exercise group (3/11, 27%) withdrew from the study than the placebo group (1/10, 10%) (risk ratio (RR) 2.73, 95% CI 0.34 to 22.16). Exercise plus usual pharmacological care versus usual pharmacological care alone The addition of exercise to usual pharmacological care may have little to no effect on fatigue, functional capacity, and disease activity (low-certainty evidence). We are uncertain whether the addition of exercise improves pain (very low-certainty evidence), or results in fewer or more withdrawals (very low-certainty evidence). Serious adverse events and quality of life were not reported. Exercise plus usual care versus another non-pharmacological intervention such as receiving information about the disease or relaxation therapy Compared with education or relaxation therapy, exercise may reduce fatigue slightly (low-certainty evidence), may improve functional capacity (low-certainty evidence), probably results in little to no difference in disease activity (moderate-certainty evidence), and may result in little to no difference in pain (low-certainty evidence). We are uncertain whether exercise results in fewer or more withdrawals (very low-certainty evidence). Quality of life and serious adverse events were not reported. AUTHORS' CONCLUSIONS: Due to low- to very low-certainty evidence, we are not confident on the benefits of exercise on fatigue, functional capacity, disease activity, and pain, compared with placebo, usual care, or advice and relaxation therapy. Harms data were not well reported.

Contemporary Outcomes of Elective Parastomal Hernia Repair in Older Adults.

Importance: Parastomal hernia is a challenging complication following ostomy creation; however, the incidence and long-term outcomes after elective parastomal hernia repair are poorly characterized. Objective: To describe the incidence and long-term outcomes after elective parastomal hernia repair. Design, Setting, and Participants: Using 100% Medicare claims, a retrospective cohort study of adult patients who underwent elective parastomal hernia repair between January 1, 2007, and December 31, 2015, was performed. Logistic regression and Cox proportional hazards models were used to evaluate mortality, complications, readmission, and reoperation after surgery. Analysis took place between February and May 2022. Exposures: Parastomal hernia repair without ostomy resiting, parastomal hernia repair with ostomy resiting, and parastomal hernia repair with ostomy reversal. Main Outcomes and Measures: Mortality, complications, and readmission within 30 days of surgery and reoperation for recurrence (parastomal or incisional hernia repair) up to 5 years after surgery. Results: A total of 17 625 patients underwent elective parastomal hernia repair (mean [SD] age, 73.3 [9.1] years; 10 059 female individuals [57.1%]). Overall, 7315 patients (41.5%) underwent parastomal hernia repair without ostomy resiting, 2744 (15.6%) underwent parastomal hernia repair with ostomy resiting, and 7566 (42.9%) underwent parastomal hernia repair with ostomy reversal. In the 30 days after surgery, 676 patients (3.8%) died, 7088 (40.2%) had a complication, and 1740 (9.9%) were readmitted. The overall adjusted 5-year cumulative incidence of reoperation was 21.1% and was highest for patients who underwent parastomal hernia repair with ostomy resiting (25.3% [95% CI, 25.2%-25.4%]) compared with patients who underwent parastomal hernia repair with ostomy reversal (18.8% [95% CI, 18.7%-18.8%]). Among patients whose ostomy was not reversed, the hazard of repeat parastomal hernia repair was the same for patients whose ostomy was resited vs those whose ostomy was not resited (adjusted hazard ratio, 0.93 [95% CI, 0.81-1.06]). Conclusions and Relevance: In this study, more than 1 in 5 patients underwent another parastomal or incisional hernia repair within 5 years of surgery. Although this was lowest for patients who underwent ostomy reversal at their index operation, ostomy resiting was not superior to local repair. Understanding the long-term outcomes of this common elective operation may help inform decision-making between patients and surgeons regarding appropriate operative approach and timing of surgery.

Telehealth-supervised exercise in systemic lupus erythematosus: A pilot study.

OBJECTIVES: To explore the feasibility and effectiveness of telehealth-supervised exercise for adults with Systemic lupus erythematosus (SLE). METHODS: This was a non-randomised controlled pilot trial comparing telehealth-supervised exercise (8 weeks, 2 days/week, 45 min, moderate intensity) plus usual care with usual care alone. Mixed methods were used to assess change in fatigue (FACIT-fatigue), quality of life (SF36), resting fatigue and pain (11-point scale), lower body strength (five-time sit-to-stand) and endurance (30 s sit-to-stand), upper body endurance (30 s arm curl), aerobic capacity (2 min step test), and experience (survey and interviews). Group comparison was performed statistically using a two-sample T-test or Mann-Whitney U-test. Where known, we used MCID or MCII, or assumed a change of 10%, to determine clinically meaningful change within groups over time. Interviews were analysed using reflexive thematic analysis. RESULTS: Fifteen female adults with SLE were included (control group n = 7, exercise group n = 8). Statistically significant differences between groups, in favour of the exercise intervention, were noted for SF36 domain emotional well-being (p = 0.048) and resting fatigue (p = 0.012). There were clinically meaningful improvements over time for FACIT-fatigue (+6.3 ± 8.3, MCID >5.9), SF36 domains physical role functioning (+30%), emotional role functioning (+55%), energy/fatigue (+26%), emotional well-being (+19%), social functioning (+30%), resting pain (-32%), and upper body endurance (+23%) within the exercise group. Exercise attendance was high (98%, 110/112 sessions); participants strongly agreed (n = 5/7, 71%) or agreed (n = 2/7, 29%) they would do telehealth-supervised exercise again and were satisfied with the experience. Four themes emerged: (1) ease and efficiency of exercising from home, (2) value of live exercise instruction, (3) challenges of exercising at home, and (4) continuation of telehealth-supervised exercise sessions. CONCLUSION: Key findings from this mixed-method investigation suggest that telehealth-supervised exercise was feasible for, and well-accepted by, adults with SLE and resulted in some modest health improvements. We recommend a follow-up RCT with more SLE participants.

Comparative Safety of Sleeve Gastrectomy and Gastric Bypass up to 5 Years After Surgery in Patients With Medicaid.

OBJECTIVE: Compare adverse outcomes up to 5 years after sleeve gastrectomy and gastric bypass in patients with Medicaid. BACKGROUND: Sleeve gastrectomy is the most common bariatric operation among patients with Medicaid; however, its long-term safety in this population is unknown. METHODS: Using Medicaid claims, we performed a retrospective cohort study of adult patients who underwent sleeve gastrectomy or gastric bypass from January 1, 2012, to December 31, 2018. Instrumental variables survival analysis was used to estimate the cumulative incidence and heterogeneity of outcomes up to 5 years after surgery. RESULTS: Among 132,788 patients with Medicaid, 84,717 (63.8%) underwent sleeve gastrectomy and 48,071 (36.2%) underwent gastric bypass. A total of 69,225 (52.1%) patients were White, 33,833 (25.5%) were Black, and 29,730 (22.4%) were Hispanic. Compared with gastric bypass, sleeve gastrectomy was associated with a lower 5-year cumulative incidence of mortality (1.29% vs 2.15%), complications (11.5% vs 16.2%), hospitalization (43.7% vs 53.7%), emergency department (ED) use (61.6% vs 68.2%), and reoperation (18.5% vs 22.8%), but a higher cumulative incidence of revision (3.3% vs 2.0%). Compared with White patients, the magnitude of the difference between sleeve and bypass was smaller among Black patients for ED use [5-y adjusted hazard ratios: 1.01; 95% confidence interval (CI), 0.94-1.08 vs 0.94 (95% CI, 0.88-1.00), P <0.001] and Hispanic patients for reoperation [5-y adjusted hazard ratios: 0.95 (95% CI, 0.86-1.05) vs 0.76 (95% CI, 0.69-0.83), P <0.001]. CONCLUSIONS: Among patients with Medicaid undergoing bariatric surgery, sleeve gastrectomy was associated with a lower risk of mortality, complications, hospitalization, ED use, and reoperations, but a higher risk of revision compared with gastric bypass. Although the difference between sleeve and bypass was generally similar among White, Black, and Hispanic patients, the magnitude of this difference was smaller among Black patients for ED use and Hispanic patients for reoperation.

Association of Modified Systemic Lupus Erythematosus Responder Index Attainment With Long-Term Clinical Outcomes: A Five-Year Prospective Study.

OBJECTIVE: In trials of systemic lupus erythematosus (SLE), the SLE Responder Index (SRI) is the most commonly used primary efficacy end point but has limited validation against long-term outcomes. We aimed to investigate associations of attainment of a modified version of the SRI (mSRI) with key clinical outcomes in SLE patients with up to 5 years of follow-up. METHODS: We used data from a large multicenter, longitudinal SLE cohort in which patients received standard of care. The first visit with active disease (defined as SLE Disease Activity Index 2000 [SLEDAI-2K] score ≥6) was designated as baseline, and mSRI attainment (defined as a reduction in SLEDAI-2K ≥4 points with no worsening in physician global assessment ≥0.3 points) was determined at annual intervals from baseline up to 5 years. Associations between mSRI attainment and outcomes including disease activity, glucocorticoid dose, flare, damage accrual, Lupus Low Disease Activity State (LLDAS), and remission were studied. RESULTS: We included 2,060 patients, with a median baseline SLEDAI-2K score of 8. An mSRI response was attained by 56% of patients at 1 year, with similar responder rates seen at subsequent annual time points. Compared to nonresponders, mSRI responders had significantly lower disease activity and prednisolone dose and higher proportions of LLDAS and remission attainment at each year, and less damage accrual at years 2 and 3. Furthermore, mSRI responder status at 1 year predicted clinical benefit at subsequent years across most outcomes, including damage accrual (odds ratio [OR] range 0.58-0.69, P < 0.05 for damage accrual ORs at all time points). CONCLUSION: In SLE patients with active disease receiving standard of care, mSRI attainment predicts favorable outcomes over long-term follow-up, supporting the clinical meaningfulness of SRI attainment as an SLE trial end point.