The effect of non-pooled multi-donor faecal microbiota transplantation for inducing clinical remission in patients with chronic pouchitis: Results from a multicentre randomised double-blinded placebo-controlled trial (MicroPouch).

BACKGROUND AND AIMS: To investigate if treatment with non-pooled multi-donor faecal microbiota transplantation (FMT) for four weeks was superior to placebo to induce clinical remission in patients with chronic pouchitis. METHODS: The study was a randomised double-blinded placebo-controlled study with a 4-week intervention period and 12-month follow-up. Eligible patients with chronic pouchitis were recruited from five Danish hospitals. Participants were randomised to non-pooled multi-donor FMT derived from four faecal donors, or placebo. Treatment was delivered daily by enema for two weeks followed by every second day for two weeks. Disease severity was accessed at inclusion and 30-day follow-up, using the Pouchitis Disease Activity Index (PDAI); PDAI <7 was considered equivalent to clinical remission. Faecal samples from participants and donors were analysed by shotgun metagenomic sequencing. RESULTS: Inclusion was stopped after inclusion of 30 participants who were randomised 1:1 for treatment with FMT or placebo. There was no difference in participants achieving clinical remission between the two groups at 30-day follow-up, relative risk 1.0 (95%CI(0.55;1.81)). Treatment with FMT resulted in a clinically relevant increase in adverse events compared to placebo, incidence rate ratio 1.67 (95%CI(1.10;2.52)); no serious adverse events within either group. Faecal microbiota transplantation statistically significantly increased the similarity of participant faecal microbiome to the faecal donor microbiome at 30-days follow-up (p=0.01), which was not seen after placebo. CONCLUSIONS: Non-pooled multi-donor FMT was comparable to placebo in inducing clinical remission in patients with chronic pouchitis but showed a clinically relevant increase in adverse events compared to placebo.

Temporal trends in mortality in patients with systemic lupus erythematosus: a Danish population-based matched cohort study.

OBJECTIVE: Excess mortality has been demonstrated in patients with systemic lupus erythematosus (SLE) compared with the general population. We aimed to investigate the 5-year and 10-year all-cause mortality in patients with SLE compared with the general population in recent decades. METHODS: Nationwide population-based exposure matched cohort study. Incident cases of SLE diagnosed between 1996 and 2015 were identified using administrative health registries and followed until 2020, allowing for 5 and 10 years of follow-up. Patients with SLE were matched 1:5 on age and sex with individuals from the Danish general population. Time-to-event analyses were performed using the pseudo-observation approach. RESULTS: In total, 1351 incident cases of SLE and 6755 matched controls were identified. The crude risk difference (RD) for 5 years mortality decreased over the study period from 10.3% (95% CI 6.5-14.1%) to 4.6% (95% CI 1.4-7.8%) for patients with SLE compared with controls. The relative risk (RR) for 5-year mortality decreased similarly in the same period. Adjustment for comorbidities revealed lower RD and RR for mortality, but the decreasing trend remained. Crude and adjusted RD and RR for 10-year mortality did not change over calendar period. The 10-year RR was highest in young patients <50 years of age. CONCLUSION: Five-year mortality risk decreased over time for both patients with SLE and matched controls. However, excess 5-year mortality in the most recent calendar period and mortality late in the disease course remained. Continued focus on preventing disease progression and comorbidity is required.

Aortic Root Dimension Using Transthoracic Echocardiography: Results from the Copenhagen City Heart Study.

Findings regarding the relation between aortic size and risk factors are heterogeneous. This study aimed to generate new insights from a population-based adult cohort on aortic root dimensions and their association with age, anthropometric measures, and cardiac risk factors and evaluate the incidence of acute aortic events. Participants from the fifth examination round of the Copenhagen City Heart study (aged 20 to 98 years) with applicable echocardiograms and no history of aortic disease or valve surgery were included. Aorta diameter was assessed at the annulus, sinus of Valsalva, sinotubular junction, and the tubular part of the ascending aorta. The study population comprised 1,796 men and 2,316 women; mean age: 56.4 ± 17.0 and 56.9 ± 18.1 years, respectively. Men had larger aortic root diameters than women regardless of height indexing (p <0.01). Age, height, weight, systolic and diastolic blood pressure, mean arterial pressure, pulse pressure, hypertension, diabetes, ischemic heart disease, and smoking were positively correlated with aortic sinus diameter in the crude and gender-adjusted analyses. However, after full adjustment, only height, weight, and diastolic blood pressure remained significantly positively correlated with aortic sinus diameter (p <0.001). For systolic blood pressure and pulse pressure, the correlation was inverse (p <0.001). During follow-up (median 5.4 [quartile 1 to quartile 3 4.5 to 6.3] years), the incidence rate of first-time acute aortic events was 13.6 (confidence interval 4.4 to 42.2) per 100,000 person-years. In conclusion, beyond anthropometric measures, age, and gender, diastolic blood pressure was the only cardiac risk factor that was independently correlated with aortic root dimensions. The number of aortic events during follow-up was low.

Cancer risk with tocilizumab/sarilumab, abatacept, and rituximab treatment in patients with rheumatoid arthritis: a Danish cohort study.

OBJECTIVES: To investigate cancer risk in rheumatoid arthritis (RA) patients treated with tocilizumab/sarilumab, abatacept, or rituximab compared with those who received tumour necrosis factor inhibitors (TNFi) and compared with biological disease-modifying anti-rheumatic drugs (bDMARD) naïve RA patients. METHODS: Nationwide registry-based cohort study of RA patients initiating treatment with tocilizumab/sarilumab, abatacept, rituximab, TNFi, and bDMARD-naive patients their second type of conventional synthetic DMARD (csDMARD). Patients were identified in DANBIO and followed for cancer from 2006-2020. Patients could contribute multiple treatments, with person years (PYRS), deaths, and cancers allocated to each treatment group in a 'latest type of treatment' manner. Inverse probability of treatment weighting and weighted cause-specific Cox models were used to calculate hazard ratios (HRs) for cancer in each tocilizumab/sarilumab, abatacept, and rituximab group compared with TNFI and bDMARD naïve groups, respectively. RESULTS: In total, 21 982 treatment initiations, 96 475 PYRS, and 1423 cancers were identified. There were no statistically significant increased HRs for overall cancer in tocilizumab/sarilumab, abatacept, or rituximab treatment groups (HRs ranged from 0.7-1.1). More than five years of abatacept exposure showed a non-significantly increased HR compared with TNFi (HR 1.41, 95% confidence intervals CI 0.74-2.71). For hematological cancers, rituximab treatment showed non-significantly reduced HRs: vs TNFi (HR 0.09; 95%CI 0.00-2.06) and bDMARD-naïve (HR 0.13; 95%CI 0.00-1.89). CONCLUSION: Treatment with tocilizumab/sarilumab, abatacept, or rituximab in RA patients was not associated with increased risks of cancer compared with TNFi-treated and with bDMARD-naïve RA patients in a real-world setting.

Cancer risk in patients with rheumatoid arthritis treated with janus kinase inhibitors: a nationwide Danish register-based cohort study.

OBJECTIVES: We aimed to investigate the risk of first primary cancer in patients with RA treated with janus kinase inhibitors (JAKi) compared with those who received biologic DMARDs (bDMARDs) in a real-world setting. METHODS: We performed an observational cohort study using the nationwide registers in Denmark. Patients with RA aged 18+ years, without a previous cancer diagnosis, and who initiated treatment with JAKi or bDMARDs from 1 January 2017 to 31 December 2020 were followed for any cancer (except non-melanoma skin cancer). We applied inverse probability of treatment weighting (IPTW) to account for covariate differences between treatment groups. IPTW-generated weights were used with cause-specific Cox (CSC) models to calculate hazard ratios (HRs) for cancer incidence in JAKi-treated compared with bDMARD-treated patients with RA. RESULTS: We identified 875 and 4247 RA patients treated with JAKi and bDMARDs, respectively. The JAKi group contributed 1315 person years (PYRS) and 19 cancers, the bDMARD group contributed 8597 PYRS and 111 cancers, with corresponding crude incidence rates per 1000 PYRS of 14.4 and 12.9. Comparing the two groups using weighted CSC models, a HR of 1.41 (95% CI 0.76, 2.37, 95% CIs) was seen for JAKi- vs bDMARD-treated patients with RA. CONCLUSION: JAKi treatment in real-world patients with RA was not associated with a statistically significant increased risk of first primary cancer compared with those who received bDMARDs. However, several numerically increased risk estimates were detected, and a clinically important excess risk of cancer among JAKi recipients cannot be dismissed.

Temporal trends in mortality in patients with rheumatoid arthritis: a Danish population-based matched cohort study.

OBJECTIVES: To investigate the 5-year all-cause mortality in patients with RA compared with the general population. METHODS: This was a nationwide population-based matched cohort study. RA patients diagnosed between 1996 and the end of 2015 were identified using administrative heath registries and followed until the end of 2020 allowing 5 years of follow-up. Patients with incident RA were matched 1:5 on year of birth and sex with non-RA individuals from the Danish general population. Time-to-event analyses were performed using the pseudo-observation approach. RESULTS: Compared with matched controls in 1996-2000, the risk difference for RA patients ranged from 3.5% (95% CI 2.7%, 4.4%) in 1996-2000 to -1.6% (95% CI -2.3%, -1.0%) in 2011-15, and the relative risk from 1.3 (95% CI 1.2, 1.4) in 1996-2000 to 0.9 (95% CI 0.8, 0.9) in 2011-15. The age-adjusted 5-year cumulative incidence proportion of death for a 60-year-old RA patient decreased from 8.1% (95% CI 7.3%, 8.9%) when diagnosed in 1996-2000 to 2.9% (95% CI 2.3%, 3.5%) in 2011-15, and for matched controls from 4.6% (95% CI 4.2%, 4.9%) to 2.1% (95% CI 1.9%, 2.4%). Excess mortality persisted in women with RA throughout the study period, while the mortality risk for men with RA in 2011-15 was similar to their matched controls. CONCLUSIONS: Enhanced improvement in mortality was found in RA patients compared with matched controls, but for sex-specific differences excess mortality was only persistent in women with RA.

Treatment of posterior Benign Paroxysmal Positional Vertigo is efficient and safe with a new Mechanical Rotational Chair.

Background: Benign paroxysmal positional vertigo (BPPV) is the most predominant vestibular disease. Previously, in the management of BPPV, both therapeutic and diagnostic benefits with mechanical rotation chairs (MRCs) have been reported. However, no previous studies have examined the efficacy of MRC treatment with a fairly new MRC. Methods: Randomized three-armed parallel open-labeled prospective clinical trial. One hundred and five patients diagnosed with posterior BPPV underwent diagnostics and treatment with an MRC. Patients were randomized to either a Semont maneuver, an Epley maneuver or a 360-degree backwards somersault maneuver. Primary endpoint was to evaluate the efficiency of an MRC in the treatment of posterior BPPV with three separate treatment modalities. Secondary objectives included subjective vertigo assessments. Results: BPPV treatment with this MRC is very efficient with success rates up to 97.1 percent. The number of treatments required to achieve complete resolution of both objective findings and subjective symptoms was 1.5. Almost 47 percent of patients experienced complete resolution of both subjective and objective measures following one (first) treatment. All Dizziness Handicap Inventory scores decreased significantly post-treatment. Conclusion: Treatment of posterior BPPV, with the MRC used in this study, was very efficient with both the Semont, the Epley, and the 360-degree backwards somersault maneuver. Based on the findings in this study, this fairly new MRC seems both effective and safe to use.

Predicting successful biologics tapering in patients with inflammatory arthritis: Secondary analyses based on the BIOlogical Dose OPTimisation (BIODOPT) trial.

AIMS: To evaluate predictors for successful biologic tapering among patients with inflammatory arthritis using baseline characteristics from the BIODOPT trial. METHODS: Adult patients with rheumatoid arthritis, psoriatic arthritis or axial spondyloarthritis on stable biologic dose and in low disease activity ≥12 months were enrolled. Participants were randomized (2:1) to disease activity-guided biologic tapering or continuation of baseline biologic. Patients achieving successful tapering reduced their biologic dose by ≥50%, had no protocol deviations and were in low disease activity at 18 months. Modified Poisson regression with robust variance estimator was applied. RESULTS: In total, 142 patients were randomized to tapering (n = 95) or control (n = 47). Successful tapering was achieved by 32 and 2%, respectively. Tapering group was the only statistically significant independent predictor for successful tapering, risk ratio (RR): 14.0 (95% confidence interval [CI]: 1.9 to 101.3, P = .009). However, higher Short Form Health Survey 36 mental component summary (SF-36 MCS) was observed to be a predictor of potential importance, RR: 1.06 (95% CI: 0.99 to 1.13, P = .097). When limiting the analyses to the tapering group only, none of the baseline variables were statistically significant independent predictors but SF-36 MCS was still considered to be of potential importance, RR: 1.05 (95% CI: 0.99 to 1.12, P = .098). CONCLUSION: Successful tapering is a reachable target for 1 in 3 patients with inflammatory arthritis who are interested in reducing their biological therapy. No statistically significant predictors (besides allocation to tapering) were identified. Future research on mental health and tapering is encouraged.

Indeterminate thyroid cytology in an iodine-deficient population: Prevalence, operation rate, risk of malignancy anddiagnostic value of thyroid scintigraphy and 18F-FDG PET imaging parameters.

OBJECTIVE: Patients with indeterminate thyroid cytology often have a diagnostic hemithyroidectomy. The role of molecular imaging, particularly fluorine-18-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET), is controversial, and demographic variations in tumor prevalence and histology influence test performance and clinical utility. We retrospectively assessed the prevalence of indeterminate thyroid cytology and the malignancy rate in patients from an iodine deficient area, and evaluated the diagnostic value of preoperative thyroid scintigraphy and 18F-FDG PET/CT among operated patients. SUBJECTS AND METHODS: From 2006-2018, all patients with indeterminate thyroid cytology from the North Denmark region were included in the study (population 600,000).Clinical data, including operation rate, preoperative molecular imaging, and histopathological diagnosis, were retrieved. The results from preoperative thyroid scintigraphy and 18F-FDG PET/CT-scanning were compared to the final histopathological diagnosis. RESULTS: Four hundred and thirty-three patients were found with indeterminate thyroid cytology.The main registered reasons for conducting a fine needle aspiration biopsy (FNAB) were "cold nodule", goiter or a palpable nodule (n=312). In 40 patients (9%), FNAB was registered as conducted due to a PET incidentaloma. Four hundred and two patients (93%) underwent diagnostic lobectomy, and this population formed the study population for the following explorative study: One-hundred and two patients (25%) had a malignant diagnosis. In 226 (56%) and 51 (25%) patients, respectively, preoperative thyroid scintigraphy and 18F-FDG PET/computed tomography (CT) was performed. Among patients with a final malignant disease who had a thyroid scintigraphy (40 patients), a cold nodule was seen in 90% of cases; one (atypical) patient presented a warm nodule. Among patients with a final malignant disease 16 patients (16%) had a 18F-FDG PET (incl. 3 missing PET scans). Among the 51 patients with preoperative 18F-FDG PET/CT, no difference in the PET-derived parameters was found between benign (n=33) and malignant tumors (n=13). CONCLUSION: The prevalence of malignancy (25%) was comparable with that in other studies. In patients with a preoperative thyroid scintigraphy, 90% of malignant cases had a cold nodule on scintigraphy. In patients with a preoperative PET/CT-scanning presenting focal 18F-FDG-uptake, PET-derived parameters had no diagnostic value. However, the diagnostic value of 18F-FDG-avidity vs. non-avidity needs to be addressed prospectively.

Validation of the Modified Fatigue Impact Scale in patients with systemic lupus erythematosus.

INTRODUCTION: Patients with systemic lupus erythematosus (SLE) experience significant fatigue, a debilitating symptom associated with reduced quality of life. There has not yet been agreed on a simple and reliable method for assessing fatigue in SLE. OBJECTIVES: To investigate the internal consistency, test-retest reliability and construct validity (convergent and discriminant validity) of the Modified Fatigue Impact Scale (MFIS) in patients with SLE. The secondary objective was to investigate the contribution of disease activity and organ damage to fatigue. METHODS: Fatigue was assessed using the MFIS in 61 patients with SLE. Internal consistency of MFIS was assessed with Cronbach's alpha (α) and Principal Component Analysis. Test-retest reliability was evaluated using the intraclass correlation coefficient (ICC). Construct validity was studied using Spearman's rank correlation (rs). Associations between MFIS and disease activity and organ damage were estimated with rs. RESULTS: Internal consistency of the MFIS was excellent with Cronbach's α = 0.97 (95% confidence interval (CI): 0.96-0.98) for the complete scale. Test-retest reliability was good with ICC = 0.89 (95% CI: 0.78-0.95, p < 0.001). Construct validity was confirmed by Spearman's correlation (VT-SF36: rs = -0.73, p < 0.001. MH-SF36: rs = 0.70, p < 0.001). No significant correlation was found between the MFIS and SLEDAI (rs = 0.03, p = 0.83). There was a moderate correlation between MFIS and SLICC Damage Index (rs = 0.43, p < 0.001). CONCLUSION: The present study found the MFIS to be a reliable and valid instrument for assessing fatigue in SLE. Further investigations are needed to clarify if an association between measured fatigue and disease components exists.

Isolation in patients with inflammatory rheumatic diseases during COVID-19 pandemic compared to healthy individuals: a questionnaire survey.

As a result of the pandemic, many patients with an inflammatory rheumatic disease (IRD) have isolated themselves. The lack of disease management together with fear of infection could lead to changes in physical- and mental health. The aim of this study was to evaluate the social- and health behaviour in patients with an IRD compared with the behaviour of healthy individuals during the COVID-19 pandemic. The study was a questionnaire survey answered by patients with an IRD and healthy individuals (HI). The questionnaire contained seven sections with questions regarding COVID-19 and quality of life including SF-36, EQ-5D-5L, and visual analogue scale (VAS) pain, fatigue and global health. Of 1663 invited participants, 661 patients with IRD and 266 HI were included in the analyses. Patients with an IRD felt more isolated during the COVID-19 pandemic compared with HI (IRD: 9.5% (61/644), HI: 3.1% (8/259), p-value = 0.001). More HI (5.4%) had been infected with COVID-19 than patients with an IRD (1.7%). Among patients with an IRD those with worse self-reported disease activity outcomes (VAS pain, fatigue and global health, all p-value < 0.001), worse social functioning and emotional well-being were more isolated than individuals with low disease activity. Patients with an IRD feel more isolated during the COVID-19 pandemic compared to HI. Isolation seems to be most pronounced in patients with worse disease related patient-reported outcomes and lower quality of life.

COVID-19 infection and hospitalization risk according to vaccination status and DMARD treatment in patients with rheumatoid arthritis.

OBJECTIVES: The objectives of this study were to investigate the incidence of COVID-19 hospitalization in unvaccinated and vaccinated patients with RA compared with matched controls, and in patients with RA according to DMARD treatment. METHODS: This was a Danish nationwide matched-cohort study from January to October 2021. Patients with RA were identified in the DANBIO register and matched 1:20 with individuals from the general population on age, sex, and vaccination status. Primary and secondary outcomes were COVID-19 hospitalization (Danish National Patient Register) and first-time positive SARS-CoV-2 PCR test (Danish COVID-19 Surveillance Register), respectively. Stratified by vaccination status, incidence rates (IRs) per 1000 person years (PYs) and comorbidity-adjusted hazard ratios (aHRs) in cause-specific Cox models were calculated with 95% confidence intervals. RESULTS: In total, 28 447 unvaccinated patients and 568 940 comparators had IRs for COVID-19 hospitalization of 10.4 (8.0-13.4) and 4.7 (4.3-5.1) per 1000 PYs, respectively (aHR 1.88, 1.44-2.46). When fully vaccinated, corresponding IRs were 0.9 (0.5-1.6) and 0.5 (0.4-0.6) per 1000 PYs (aHR 1.94, 1.03-3.66). Unvaccinated RA patients had an aHR of 1.22 (1.09-1.57) for testing positive for SARS-CoV-2 and 1.09 (0.92-1.14) among vaccinated RA patients. Vaccinated rituximab-treated patients had increased crude IR of COVID-19 hospitalization compared with conventional DMARD-treated patients. CONCLUSION: The incidence of COVID-19 hospitalization was increased for both unvaccinated and vaccinated patients with RA compared with controls. Importantly, the parallel decreasing risk for patients with RA suggests a comparable relative benefit of vaccination in most patients.

Cannabidiol treatment in hand osteoarthritis and psoriatic arthritis: a randomized, double-blind, placebo-controlled trial.

ABSTRACT: Cannabidiol (CBD) is increasingly used as analgesic medication although the recent International Association for the Study of Pain Presidential Task Force on cannabis and cannabinoid analgesia found a lack of trials examining CBD for pain management. This trial examines CBD as add-on analgesic therapy in patients with hand osteoarthritis or psoriatic arthritis experiencing moderate pain intensity despite therapy. Using a randomized, double-blind, placebo-controlled design, patients received synthetic CBD 20 to 30 mg or placebo daily for 12 weeks. The primary outcome was pain intensity during the past 24 hours (0-100 mm); safety outcomes were percentage of patients experiencing adverse events and a characterization of serious adverse events. Explorative outcomes included change in Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, Pain Catastrophizing Scale (PCS), and Health Assessment Questionnaire Disability Index. One hundred thirty-six patients were randomized, of which 129 were included in the primary analysis. Between-group difference in pain intensity at 12 weeks was 0.23 mm (95% confidence interval -9.41 to 9.90; P = 0.96). Twenty-two percent patients receiving CBD and 21% receiving placebo experienced a reduction in pain intensity of more than 30 mm. We found neither clinically nor statistically significant effects of CBD for pain intensity in patients with hand osteoarthritis and psoriatic arthritis when compared with placebo. In addition, no statistically significant effects were found on sleep quality, depression, anxiety, or pain catastrophizing scores.

Intake of marine n-3 polyunsaturated fatty acids and the risk of rheumatoid arthritis: protocol for a cohort study using data from the Danish Diet, Cancer and Health cohort and Danish health registers.

INTRODUCTION: Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory joint disease with multifactorial aetiology. Smoking is a well-established lifestyle risk factor, but diet may also have an impact on the risk of RA. Intake of the major marine n-3 polyunsaturated fatty acids in particular eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have been hypothesised to lower the risk of RA due to their anti-inflammatory effects, although based on limited knowledge. Therefore, we aim to investigate the associations between dietary intake of EPA and DHA and the risk of incident RA. METHODS AND ANALYSIS: A cohort study. The follow-up design will be based on data from the Danish Diet, Cancer and Health cohort, which was established between 1993 and 1997. The participants will be followed through record linkage using nationwide registers including the Danish Civil Registration System, the Danish National Patient Registry and the Danish National Prescription Registry using the unique Civil Personal Registration number. Time-to-event analyses will be conducted with RA as the outcome of interest. The participants will be followed from inclusion until date of RA diagnosis, death, emigration or end of follow-up. HRs with 95% CIs obtained using Cox proportional hazard regression models, with age as underlying time scale and adjustment for established and potential risk factors, will be used as measures of association. ETHICS AND DISSEMINATION: The study has been approved by the Data Protection Committee of Northern Jutland, Denmark (2019-87) and the North Denmark Region Committee on Health Research Ethics (N-20190031). Study results will be disseminated through peer-reviewed journals and presentations at international conferences.

Incidence of COVID-19 Hospitalisation in Patients with Systemic Lupus Erythematosus: A Nationwide Cohort Study from Denmark.

BACKGROUND: Patients with systemic lupus erythematosus (SLE) have an increased risk of infections due to impaired immune functions, disease activity, and treatment. This study investigated the impact of having SLE on the incidence of hospitalisation with COVID-19 infection. METHODS: This was a nationwide cohort study from Denmark between 1 March 2020 to 2 February 2021, based on the linkage of several nationwide registers. The adjusted incidence of COVID-19 hospitalisation was estimated for patients with SLE compared with the general population in Cox-regression models. Among SLE patients, the hazard ratio (HR) for hospitalisation was analysed as nested case-control study. RESULTS: Sixteen of the 2533 SLE patients were hospitalised with COVID-19 infection. The age-sex adjusted rate per 1000 person years was 6.16 (95% CI 3.76-10.08) in SLE patients, and the corresponding hazard ratio was 2.54 (95% CI 1.55-4.16) compared with the matched general population group after adjustment for comorbidities. Among SLE patients, hydroxychloroquine treatment was associated with a HR for hospitalisation of 0.61 (95% CI 0.19-1.88), and 1.06 (95% CI 0.3-3.72) for glucocorticoid treatment. CONCLUSION: Patients with SLE were at increased risk of hospitalisation with COVID-19.

Efficacy of methylprednisolone on pain, trismus and quality of life following surgical removal of mandibular third molars: a double-blind, split-mouth, randomised controlled trial / Eficacia de la metilprednisolona sobre el dolor, el trismo y la calidad de vida después de la extirpación quirúrgica de los terceros molares mandibulares: un ensayo controlado aleatorio, doble ciego, de boca dividida

Background: The objective of the present study was to compare the efficacy of different doses of methylpredniso-lone on postoperative sequelae and quality of life (QoL) following surgical removal of mandibular third molars(SRM3).Material and Methods: Fifty-two patients (16 men and 36 women, mean age 25.9 years, range: 18-39) with bilateralimpacted mandibular third molars were randomly allocated into intraoperative muscular injection of either 20mg,30mg, 40mg methylprednisolone or saline injection. Baseline measurements were obtained preoperatively andcompared with assessment after one day, three days, seven days and one month. Pain and trismus were estimatedby visual analog scale score and interincisal mouth opening, respectively. Subjective assessment of QoL includedOral Health Impact Profile (OHIP-14). Descriptive and generalized estimating equation analyses were made andexpressed as mean values with a 95% confidence interval.Results: Methylprednisolone revealed no significant differences in pain, trismus and QoL compared with placebo.Higher prevalence of postoperative pain and worsening in QoL were observed with increased age (P=0.00).Smoking and increased time of surgery decreased mouth opening in the early healing phase (P=0.00).Conclusions: The present study revealed no significant improvement of methylprednisolone on postoperative se-quelae and QoL following SRM3 compared with placebo.(AU)

What is the association between MRI and conventional radiography in measuring femoral head migration?

Background and purpose - Pelvic radiographs are traditionally used for assessing femoral head migration in residual acetabular dysplasia (RAD). Knowledge of the heightened importance of cartilaginous structures in this condition has led to increased use of MRI in assessing both osseous and cartilaginous structures of the pediatric hip. Therefore, we assessed the relationship between migration percentages (MP) found on MRI and conventional radiographs. Second, we analyzed the reliability of MP in MRI and radiographs.Patients and methods - We retrospectively identified 16 patients (mean age 5 years [2-8], 14 girls), examined for RAD during a period of 2½ years. 4 raters performed blinded repeated measurements of osseous migration percentage (MP) and cartilaginous migration percentage (CMP) in MRI and radiographs. Pelvic rotation and tilt indices were measured in radiographs. Bland-Altman (B-A) plots and intraclass correlation coefficients (ICC) were calculated for agreement and reliability.Results - B-A plots for MPR and MPMRI produced a mean difference of 6.4 with limits of agreement -11 to 24, with higher disagreements at low average MP values. Mean MPR differed from mean MPMRI (17% versus 23%, p < 0.001). MPR had the best interrater reliability with an ICC of 0.92 (0.86-0.96), compared with MPMRI and CMP with ICC values of 0.61 (0.45-0.70) and 0.52 (0.26-0.69), respectively. Intrarater reliability for MPR, MPMRI and CMP all had ICC values above 0.75 and did not differ statistically significantly. Differences inMPMRI and MPR showed no correlation to pelvic rotation index, pelvic tilt index, or interval between radiograph and MRI exams.Interpretation - Pelvic radiographs underestimated MP when compared with pelvic MRI. We propose CMP as a new imaging measurement, and conclude that it has good intrarater reliability but moderate interrater reliability. Measurement of MP in radiographs and MRI had mediocre to excellent reliability.

Short-term Haematological Parameters Following Surgical Removal of Mandibular Third Molars with Different Doses of Methylprednisolone Compared with Placebo. A Randomized Controlled Trial.

OBJECTIVES: To evaluate the influence of a single intraoperative injection of methylprednisolone on short-term haematological parameters following surgical removal of mandibular third molars. MATERIAL AND METHODS: Fifty-two patients with indications for surgical removal of bilateral impacted mandibular third molars were included in a randomized, split-mouth and double-blinded study design. Each molar were randomly allocated into one of following four groups: 20 mg methylprednisolone, 30 mg methylprednisolone, 40 mg methylprednisolone and placebo. Peripheral blood samples were obtained before and three days after surgery. Haematological parameters involving haemoglobin, white blood cell count and C-reactive protein (CRP) were evaluated and expressed as mean changes. Level of significance was 0.05. Furthermore, outcomes were correlated for age, sex, smoking and time of surgery. RESULTS: There were no significant differences in postoperative haematological parameters with different doses of methylprednisolone compared with placebo. Peripheral blood samples revealed decreased level of haemoglobin and increased level of leucocytes and CRP in each group. Smokers displayed a significant lower level of haemoglobin and CRP compared with non-smokers (P < 0.05) and level of eosinophils decreased significantly with increasing age (P < 0.05). CONCLUSIONS: This study indicates that a single intraoperative injection of methylprednisolone seems not to cause suppression of short-term haematological parameters compared with placebo following surgical removal of mandibular third molars.

Maxillary Sinus Floor Augmentation With or Without Barrier Membrane Coverage of the Lateral Window: a Systematic Review and Meta-Analysis.

OBJECTIVES: Test the hypothesis of no difference in implant treatment outcomes after maxillary sinus floor augmentation with or without barrier membrane coverage of the lateral window. MATERIAL AND METHODS: A MEDLINE (PubMed), Embase and Cochrane library search in combination with a hand-search of relevant journals was conducted. Human studies published in English until the 5th of July, 2019 were included. Randomised controlled trials and controlled trials with an observation period of minimum six months were included. Primary outcomes included survival of suprastructures and implants. Secondary outcomes included implant stability quotient, peri-implant marginal bone loss, bone regeneration, patient-reported outcome measures, biologic and mechanical complications. RESULTS: The electronic search and hand-searching resulted in 1068 entries. Six randomised controlled trials characterised by low to high risk of bias and one controlled trial with high risk of bias fulfilled the inclusion criteria. High implant survival rate was reported with both treatment modalities. Meta-analyses disclosed a mean difference of newly formed bone of 6.4% (confidence interval = 0 to 12.9) and non-mineralised tissue of -1.1% (confidence interval = -2.7 to 0.5), indicating more newly formed bone and diminished non-mineralised with barrier membrane coverage. CONCLUSIONS: There seem to be no statistically significant differences in implant treatment outcomes after maxillary sinus floor augmentation with or without barrier membrane coverage of the lateral window. However, barrier membrane coverage increases percentage of newly formed bone and diminishes proliferation of non-mineralised tissue. Thus, barrier membrane coverage seems to be beneficial and also preventing displacement of the grafting material.