Clinical Characteristics of Adolescents With Juvenile Idiopathic Arthritis Transitioning to Adult Rheumatology Care in Canada: Results From the CAPRI Registry.

OBJECTIVE: Using Canadian Alliance of Pediatric Rheumatology Investigators (CAPRI) juvenile idiopathic arthritis (JIA) registry data, we describe (1) clinical characteristics of patients with JIA transitioning to adult care, (2) prevalence of disease-related damage and complications, and (3) changes in disease activity during the final year prior to transfer. METHODS: Registry participants who turned 17 years between February 2017 and November 2021 were included. Clinical characteristics and patient-reported outcomes (PROs) at the last recorded pediatric rheumatology visit, and changes observed in the year prior to that visit were analyzed. Physicians completed an additional questionnaire characterizing cumulative disease-related damage and adverse events by age 17 years. RESULTS: At their last visit, 88 of 131 participants (67%) had inactive and 42 (32%) had active disease. Overall, 96 (73%) were on medications and 41 (31%) were on biologic disease-modifying antirheumatic drugs. Among 80 participants for whom the additional questionnaire was completed, 26% had clinically detected joint damage, 31% had joint damage on imaging, 14% had uveitis, and 7.5% had experienced at least 1 serious adverse event. During the final year, 44.2% of patients were in remission, 28.4% attained inactive disease, and 27.4% became or remained active. Mean scores of PROs were stable overall during that last year, but a minority reported marked worsening. CONCLUSION: A substantial proportion of youth with JIA transitioning to adult care in Canada had a high disease burden, which was reflected by their degree of disease activity, joint damage, or ongoing medication use. These results will inform pediatric and adult providers of anticipated needs during transition of care.

Axial Spondyloarthritis: Does Magnetic Resonance Imaging Classification Improve Report Interpretation.

OBJECTIVE: The interpretation of magnetic resonance imaging (MRI) reports is crucial for the diagnosis of axial spondyloarthritis, but the subjective nature of narrative reports can lead to varying interpretations. This study presents a validation of a novel MRI reporting system for the sacroiliac joint in clinical practice. METHODS: A historical review was conducted on 130 consecutive patients referred by 2 rheumatologists for initial MRI assessment of possible axial spondyloarthritis. The original MRI reports were interpreted by the rheumatologists and the radiologist who originally read the images and then categorized according to the novel system. Two musculoskeletal radiologists then reinterpreted the original MRI scans using the new system, and the resulting reports were interpreted and categorized by the same rheumatologists. The quality of the new framework was assessed by comparing the interpretations of both reports. RESULTS: Ninety-two patients met the study criteria. The rheumatologists disagreed on the categorization of the original MRI reports in 12% of cases. The rheumatologists and original radiologists disagreed on the categorization of the initial report in 23.4% of cases. In contrast, there was 100% agreement between the rheumatologists and radiologists on the categorization of the new MRI report. CONCLUSION: The new MRI categorization system significantly improved the agreement between the clinician and radiologist in report interpretation. The system provided a standard vocabulary for reporting, reduced variability in report interpretation, and may therefore improve clinical decision-making.

A survey of Canadian adult rheumatologists' knowledge, comfort level, and barriers in assessing psychosocial needs of young adults with rheumatic diseases.

To assess adult rheumatologists' comfort level, current practices, and barriers to provision of optimal care in supporting young adults with pediatric-onset rheumatic conditions in Canada. Survey questions were informed by literature review, a needs assessment, and using milestones listed by the Royal College of Physicians and Surgeons of Canada for the entrustable professional activities (EPAs) applicable to care for rheumatology patients transitioning to adult practice. The electronic survey was distributed to adult rheumatology members of the Canadian Rheumatology Association over 4 months. Four hundred and fifty-one rheumatologists received the survey, with a response rate of 15.2%. Most respondents were from Ontario and had been in practice ≥ 10 years. Three quarters reported a lack of training in transition care although the same proportion were interested in learning more about the same. Approximately 40% felt comfortable discussing psychosocial concerns such as gender identity, sexuality, contraception, drug and alcohol use, vaping, and mental health. Despite this, 45-50% reported not discussing vaping or gender identity at all. The most frequently reported barriers to providing transition care were lack of primary care providers, allied health support, and training in caring for this age group. Most adult rheumatologists lack formal training in transition care and view it as a barrier to providing care for this unique patient population. Future educational initiatives for adult rheumatology trainees should include issues pertaining to adolescents and young adults. More research is needed to assess the effectiveness of resources such as transition navigators in ensuring a successful transition process.

Mind the Gap: A Longitudinal Analysis of the Experiences of Adolescents and Parents in a Rheumatology Transition Clinic.

BACKGROUND: The transition from pediatric to adult care is a critical time when adolescent patients and their families face many challenges. This period can be associated with an increase in disease-related morbidity and mortality. The aim of our study is to identify gaps in transition-related care to help guide areas for improvement. METHODS: Patients (14-19 years) with juvenile idiopathic arthritis or systemic lupus erythematosus and one of their parents were recruited from the McMaster Rheumatology Transition Clinic. Both were asked to complete the Mind the Gap questionnaire, a validated tool to assess experience and satisfaction with transition care in a clinic setting. The questionnaire, addressing 3 important domains of care: management of the environment, provider characteristics, and process issues, was completed twice-once based on their current clinical experience and again based on their ideal clinical encounter. Positive scores suggest current care is less than ideal; negative scores suggest current care exceeds the ideal experience. RESULTS: Most patients (n = 65, 68% female) had a diagnosis of juvenile idiopathic arthritis (87%). Patients identified mean gap scores between 0.2 and 0.3 for each domain of Mind the Gap, with female patients having higher gap scores compared with male patients. Parents (n = 51) identified gap scores between 0.0 and 0.3. Patients identified process issues as having the largest gap, whereas parents identified management of the environment as having the largest gap. CONCLUSIONS: We identified several gaps in transition clinic care relative to what patients and parents identify as ideal. These can be used to improve the rheumatology transition care that is currently being provided.

Self-Reported Transition Readiness of Adolescent Patients with Rheumatic Disease: Do the Parents Agree?

Our objective was to compare transition readiness assessment scores from adolescents with rheumatic disease with their parents and analyze their level of agreement. We found that adolescents and parents generally agree on the level of the transition readiness; however, there is occasional disagreement in specific domains.

Impact of the COVID-19 pandemic on juvenile idiopathic arthritis presentation and research recruitment: results from the CAPRI registry.

OBJECTIVE: The COVID-19 pandemic has disrupted healthcare delivery and clinical research worldwide, with data from areas most affected demonstrating an impact on rheumatology care. This study aimed to characterize the impact of the pandemic on the initial presentation of JIA and JIA-related research in Canada. METHODS: Data collected from the Canadian Alliance of Pediatric Rheumatology Investigators JIA Registry from the year pre-pandemic (11 March 2019 to 10 March 2020) was compared with data collected during the first year of the pandemic (11 March 2020 to 10 March 2021). Outcomes included time from symptom onset to first assessment, disease severity at presentation and registry recruitment. Proportions and medians were used to describe categorical and continuous variables, respectively. RESULTS: The median time from symptom onset to first assessment was 138 (IQR 64-365) days pre-pandemic vs 146 (IQR 83-359) days during the pandemic. The JIA category frequencies remained overall stable (44% oligoarticular JIA pre-pandemic, 46.8% pandemic), except for systemic JIA (12 cases pre-pandemic, 1 pandemic). Clinical features, disease activity (cJADAS10), disability (CHAQ) and quality of life (JAQQ) scores were similar between the two cohorts. Pre-pandemic, 225 patients were enrolled, compared with 111 in the pandemic year, with the greatest decrease from March to June 2020. CONCLUSIONS: We did not observe the anticipated delay in time to presentation or increased severity at presentation, suggesting that, within Canada, care adapted well to provide support to new patient consults without negative impacts. The COVID-19 pandemic was associated with an initial 50% decrease in registry enrolment but has since improved.

Infliximab therapy in refractory sarcoidosis: a multicenter real-world analysis.

BACKGROUND: Infliximab is a monoclonal antibody that binds and neutralizes circulating tumor necrosis factor-alpha, a key inflammatory cytokine in the pathophysiology of sarcoidosis. Despite the paucity of randomized clinical trials, infliximab is often considered a therapeutic option for refractory disease. Our study aimed to investigate the effectiveness of infliximab in patients with refractory sarcoidosis. METHODS: Sarcoidosis patients from three tertiary centres were retrospectively identified by pharmacy records based on treatment with infliximab. Treatment with Infliximab was initiated in patients who failed first and second line immunomodulators as determined by a multidisciplinary team of Respirologists, Dermatologists, ENT specialists, Rheumatologists, and Neurologists. Participants were characterized by the primary organ for which infliximab was initiated and the total number of organs involved. Clinical outcomes were categorized as treatment success versus failure. We defined treatment success as (A) improvement of cutaneous, upper airway, lymph node, gastrointestinal, eye, or joint manifestations; or (B) improvement or no change in central nervous system (CNS) or pulmonary manifestations. RESULTS: 33 patients with refractory sarcoidosis were identified. The proportion of treatment success was 100% (95% CI 54.1-100) in CNS, 91.7% (95% CI 61.5-99.8) in cutaneous, 78.6% (95% CI 49.2-95.3) in pulmonary and 71.5% (95% CI 29.0-96.3) in upper airway disease. The use of infliximab was associated with a reduction prednisone dose by 50%. CONCLUSION: Infliximab is possibly an effective therapy for refractory sarcoidosis, with the greatest value in neurologic and cutaneous manifestations. Across all disease presentations, infliximab facilitated a clinically relevant reduction in corticosteroid dose. Relapse is common after discontinuation of infliximab.

Contextualizing temporal arterial magnetic resonance angiography in the diagnosis of giant cell arteritis: a retrospective cohort study.

OBJECTIVES: Imaging modalities have become common in evaluating patients for a possible diagnosis of GCA. This study seeks to contextualize how temporal arterial magnetic resonance angiography (TA-MRA) can be used in facilitating the diagnosis of GCA. METHODS: A retrospective cohort study was performed on patients who had been previously referred to a rheumatologist for evaluation of possible GCA in Hamilton, Ontario, Canada. Data including clinical features, inflammatory markers, imaging, and biopsy results were extracted. Multivariable logistic regression model to predict the diagnosis of GCA. Using these models, the utility of TA-MRA in series with or in parallel to clinical evaluation was demonstrated across the cohort as well as in subgroups defined by biopsy and imaging status. RESULTS: In total 268 patients had complete data. Those diagnosed with biopsy- and/or imaging-positive GCA were more likely to demonstrate classic features including jaw claudication and vision loss. Clinical multivariable modelling allowed for fair discriminability [receiver operating characteristic (ROC) 0.759, 95% CI: 0.703, 0.815] for diagnosing GCA; there was excellent discriminability in facilitating the diagnosis of biopsy-positive GCA (ROC 0.949, 0.898-1.000). When used in those with a pre-test probability of 50% or higher, TA-MRA had a positive predictive value of 93.0%; in those with a pre-test probability of 25% or less TA-MRA had a negative predictive value of 89.5%. CONCLUSION: In those with high disease probability, TA-MRA can effectively rule in disease (and replace temporal artery biopsy). In those with low to medium probability, TA-MRA can help rule out the disease, but this continues to be a challenging diagnostic population.

Pediatric Patients with a Dual Diagnosis of Inflammatory Bowel Disease and Chronic Recurrent Multifocal Osteomyelitis.

ABSTRACT: There is a paucity of information about the epidemiology, pathophysiology, and treatment of patients with a dual diagnosis of inflammatory bowel disease (IBD) and chronic recurrent multifocal osteomyelitis (CRMO). A retrospective chart review was performed of patients at McMaster Children's Hospital with a diagnosis of either IBD or CRMO, to identify those with the dual diagnosis over a 10-year period. A dual diagnosis was identified in seven patients. Most patients (6/7) had a diagnosis of IBD first and were subsequently diagnosed with CRMO. At the time of CRMO diagnosis, IBD treatment regimens included one or more of, sulfasalazine (1/6), infliximab (3/6), adalimumab (1/6), or no treatment (1/6). Although the etiology of the link remains unknown, there does not seem to be an association to a specific IBD subtype, age, or treatment. Our patient population demonstrated a response to biologic agents, specifically tumor necrosis factor-α inhibitors, as treatment for both conditions.

Interprofessional education in the rural environment to enhance multidisciplinary care in future practice: Breaking down silos in tertiary health education.

OBJECTIVE: Western Sydney University has implemented a rural interprofessional learning programme to promote collaborative care approaches to enhance cross-discipline communications, improve knowledge and clarity of roles and improve patient care and outcomes. DESIGN: Rural interprofessinal learning is an interprofessional educational approach, consisting of simulations of complex health events. Simulation methodology frames the study with a focus on human interaction. A mixed-methods evaluation has been conducted, incorporating pre- and post- event participant surveys along with semi-structured focus groups. SETTING: Simulations are conducted in the rural setting, including community settings, working farms and rural hospitals. MAIN OUTCOME MEASURES: Reflexive thematic analysis was used to identify themes measuring students' perceptions of interdisciplinary care, knowlede of other health discipline roles and skills and how they believe the exercise will influence their future practice. Facilitator feedback regarding the efficacy of the simulations was also recorded and analysed using reflexive thematic analysis. PARTICIPANTS: Care of simulated patient(s)/bystander(s) is primarily provided by paramedicine, nursing and medical students; however, increasing interest has expanded the programme to include students from a range of allied health professions. Simulations are facilitated by a multidisciplinary team of experienced practitioners and specialists. INTERVENTION: Four rural interprofessional learning events have been held. RESULTS: 120 students have participated in the evaluation. Findings include increased understanding of the contributions of other disciplines in enhancing patient care, team approaches, cross-discipline communication and a need to engage in collaborative care in future practice. CONCLUSION: Creating a collaborative learning environment creates a culture of multidisciplinary care, enhancing patient care and improving outcomes. The rural interprofessional learning model is an effective interprofessional educational approach, which can be repeated, refined and improved for continual professional development.

Effects of Mowing and Prescribed Fire on Plant Community Structure and Function in Rare Coastal Sandplains, Nantucket Island, MA, USA.

Coastal sandplains provide habitat for a suite of rare and endangered plant and wildlife species in the northeastern United States. These early successional plant communities were maintained by natural and anthropogenic disturbances including salt spray, fire, and livestock grazing, but over the last 150 years, a decrease in anthropogenic disturbance frequency and intensity has resulted in a shift towards woody shrub dominance at the expense of herbaceous taxa. This study quantified the effects of more than a decade of dormant season disturbance-based vegetation management (mowing and prescribed fire) on coastal sandplain plant community composition on Nantucket Island, Massachusetts, USA. We used time-series plant cover data from two similar sites to evaluate the effectiveness of disturbance management for restoring herbaceous species cover and reducing woody shrub dominance. Our results indicate that applying management outside of the peak of the growing season has not been effective in maintaining or increasing the cover of herbaceous species. While management activities resulted in significant (P < 0.01) increases in herbaceous species immediately after treatment, woody species recolonized and dominated treated sites within 3-years post treatment at the expense of graminoids and forbs. These results highlight the difficulties associated with directing ecological succession using disturbance-based management to maintain rare, herbaceous species in coastal sandplain systems that were once a prevalent landscape component under historically chronic anthropogenic disturbance. Further experimentation with growing season disturbance-based management and different combinations of management techniques could provide insights into management alternatives for maintaining herbaceous conservation targets in coastal sandplains.

Determining known-group validity and test-retest reliability in the PEQ (personalized exercise questionnaire).

BACKGROUND: To determine the known-group validity, a type of construct validity, and the test-retest reliability of a newly developed tool, the Personalized Exercise Questionnaire (PEQ), that assesses the barriers, facilitators, and preferences to exercise in individuals with low bone mass and osteoporosis. METHODS: A comparative design was used to assess known-group validity and a test-retest design to examine the reproducibility. Ninety-five participants with low bone mass and osteoporosis were recruited from an outpatient clinic in Hamilton, Ontario. The questionnaire was administered to 95 participants at baseline and a subset of 42 participants completed the survey again one week later. The known-group validity of the PEQ was determined using four hypotheses that compared two known groups based on employment level, age, socioeconomic status, and physical activity level. The reproducibility of individual responses was analyzed using the Kappa Coefficient (κ). RESULTS: There was known-group validity for three of the four hypotheses. Test-retest reliability scores ranged from no agreement to almost perfect agreement; seven items had almost perfect agreement (κ: 0.81-1.00), 12 substantial agreement (κ: 0.68-0.74), six moderate agreement (κ: 0.56-0.60), two fair agreement (κ: 0.36-0.40), one slight agreement (κ = 0.23) and one no agreement (κ = - 0.03). CONCLUSION: Preliminary support for the usefulness of the PEQ is indicated since the majority of the items had at least substantial agreement and known-group validity was moderately supported for some items. TRIAL REGISTRATION: This study was retrospectively registered with ClinicalTrials.gov , NCT03125590, on April 24, 2017.

Treatment of small intestinal bacterial overgrowth in systemic sclerosis: a systematic review.

Objectives: Almost all patients with SSc have gastrointestinal manifestations. Small intestinal bacterial overgrowth (SIBO) occurs in 30-60% of patients and leads to malnutrition and impaired quality of life. Recent systematic reviews have reported efficacy of treatments for SIBO, but these are not specific to patients with SSc. We conducted a systematic review of the evidence for all possible SIBO treatments in the SSc population. Methods: The following databases were searched: MEDLINE, EMBASE and the Cochrane Library, from database inception to 1 January 2017. All evidence for all possible SIBO treatments including antibiotics, prokinetics, probiotics and alternative treatments was included. Treatment outcomes included symptomatic relief or demonstrated SIBO eradication. Results: Of 5295 articles, five non-randomized studies were reviewed with a total of 78 SSc patients with SIBO. One trial assessed octreotide while the remaining four trials investigated the effectiveness of ciprofloxacin, rifaximin, norfloxacin and metronidazole, and the combination of amoxicillin, ciprofloxacin and metronidazole. Studies were generally of low quality and most were un-controlled. Conclusion: Data indicate that, for some SSc patients, antibiotics can eradicate SIBO. There is a paucity of data reporting the effectiveness of either prokinetics or probiotics in SSc.

Recovery patterns over 4 years after distal radius fracture: Descriptive changes in fracture-specific pain/disability, fall risk factors, bone mineral density, and general health status.

STUDY DESIGN: Descriptive/Longitudinal cohort. INTRODUCTION: Distal radius fracture (DRF) is a common fall related fragility fracture that is known to be an early and independent predictor of secondary osteoporotic (OP) fractures. Changes in falls risk status, bone status and general health has not been evaluated prospectively in a population that has sustained a DRF. PURPOSE OF THE STUDY: The purpose of our study was to describe the status of fracture-specific pain/disability, fall risk factors such as physical activity (PA) and fear of falling (FOF), bone mineral density (BMD) and general health status (HS) in people with a DRF and how these variables change over four years with respect to sex, age, incidence of secondary falls and secondary OP fractures. METHODS: Patients (n = 94) self-reported their fracture-specific pain and disability (Patient-Rated Wrist Evaluation), PA (Rapid Assessment of Physical Activity), FOF (Modified Fall Efficacy Scale), HS (12-item Short Form Health Survey) and completed dual-energy X-ray absorptiometry scan based BMD assessment (lumbar spine and total hip) at baseline (1-2 weeks post-fracture), six months and four years after DRF. Descriptive statistics and general linear models were used to describe changes in recovery patterns over four years. RESULTS: There was significant (p<0.001) improvement in fracture-specific pain/disability (60 points), FOF (1 point) and physical HS (11 points) between baseline and 4 year follow-up. There were no significant changes in PA and BMD. When stratified with respect to age, sex, presence of subsequent falls and OP fractures, there were no significant differences in fracture-specific pain/disability, PA, FOF, and BMD at baseline, six months or four years after DRF. The physical HS was significantly (p<0.05) less/poorer among those with secondary falls (lower by 2-6 points) and fractures (lower by 5-6 points) compared to those without. Similarly, mental HS was significantly (p<0.05) poorer among people with secondary falls (lower by 2-6 points) and in 50-64 year age group (lower by 3-5 points) than those without secondary falls and in 65-80 year age group, respectively. CONCLUSION: Post DRF, the majority of the improvement in fracture-specific pain/disability, FOF and HS was completed at six months and very small changes were observed between the six month and four year follow-up. LEVEL OF EVIDENCE: NA.

Relationships between fatty infiltration in the thigh and calf in women with knee osteoarthritis.

BACKGROUND: In individuals with knee osteoarthritis (OA), fatty infiltration into thigh muscle is associated with poor physical performance and strength. However, it is not known whether this also occurs in the calf and if this impacts physical function. AIMS: We investigated the relationships between volumes of intramuscular fat (intraMF), intermuscular fat (IMF), subcutaneous fat (SCF), lean muscle and muscle adiposity, in the thighs compared to the calves of women with knee OA. METHODS: MRI scans of the thigh and calf were acquired from 20 women over 55 years with knee OA (3.0T Discovery MR750, GE Healthcare). Axial IDEAL (iterative decomposition of water and fat with echo asymmetry and least-squares estimation) fat-separated images were segmented to quantify intraMF, IMF, SCF and lean muscle volumes (SliceOmatic 5.0, Tomovision). Correlation and linear regression analyses were run. RESULTS: We found a positive relationship between thigh and calf intraMF (R 2 = 0.592; B = 5.49; p = 0.001), muscle adiposity (R 2 = 0.539; B = 0.567; p = 0.001), and SCF volume (R 2 = 0.699; B = 12.847; p = 0.001), controlling for waist-to-hip ratio. Relationships between thigh and calf IMF (R 2 = 0.239; B = 7.743; p = 0.061), lean muscle (R 2 = 0.245; B = 4.149; p = 0.047) and combined intraMF and IMF volume (R 2 = 0.242; B = 6.162; p = 0.044) were not significant. DISCUSSION: Although a correlation exists between thigh and calf muscle adiposity, intraMF and SCF, this does not hold true for IMF or lean muscle. A greater amount of intraMF infiltration occurs in the thigh compared to the calf of women with knee OA. CONCLUSION: The calf and thigh may both be involved in pathologic changes in muscle composition in knee OA.

Development and validation of a new tool to measure the facilitators, barriers and preferences to exercise in people with osteoporosis.

BACKGROUND: Despite the widely known benefits of exercise and physical activity, adherence rates to these activities are poor. Understanding exercise facilitators, barriers, and preferences may provide an opportunity to personalize exercise prescription and improve adherence. The purpose of this study was to develop the Personalized Exercise Questionnaire (PEQ) to identify these facilitators, barriers, and preferences to exercise in people with osteoporosis. METHODS: This study comprises two phases, instrument design and judgmental evidence. A panel of 42 experts was used to validate the instrument through quantitative (content validity) and qualitative (cognitive interviewing) methods. Content Validity Index (CVI) is the most commonly used method to calculate content validity quantitatively. There are two kinds of CVI: Item-CVI (I-CVI) and Scale-level CVI (S-CVI). RESULTS: Preliminary versions of this tool showed high content validity of individual items (I-CVI range: 0.50 to 1.00) and moderate to high overall content validity of the PEQ (S-CVI/UA = 0.63; S-CVI/Ave = 0.91). Through qualitative methods, items were improved until saturation was achieved. The tool consists of 6 domains and 38 questions. The 6 domains are: 1) support network; 2) access; 3) goals; 4) preferences; 5) feedback and tracking; and 6) barriers. There are 35 categorical questions and 3 open-ended items. CONCLUSIONS: Using an iterative approach, the development and evaluation of the PEQ demonstrated high item-content validity for assessing the facilitators, barriers, and preferences to exercise in people with osteoporosis. Upon further validation it is expected that this measure might be used to develop more client-centered exercise programs, and potentially improve adherence.

Breakdown of simple female genital fistula repair after 7 day versus 14 day postoperative bladder catheterisation: a randomised, controlled, open-label, non-inferiority trial.

BACKGROUND: Duration of bladder catheterisation after female genital fistula repair varies widely. We aimed to establish whether 7 day bladder catheterisation was non-inferior to 14 days in terms of incidence of fistula repair breakdown in women with simple fistula. METHODS: In this randomised, controlled, open-label, non-inferiority trial, we enrolled patients at eight hospitals in the Democratic Republic of the Congo, Ethiopia, Guinea, Kenya, Niger, Nigeria, Sierra Leone, and Uganda. Consenting patients were eligible if they had a simple fistula that was closed after surgery and remained closed 7 days after surgery, understood study procedures and requirements, and agreed to return for follow-up 3 months after surgery. We excluded women if their fistula was not simple or was radiation-induced, associated with cancer, or due to lymphogranuloma venereum; if they were pregnant; or if they had multiple fistula. A research assistant at each site randomly allocated participants 1:1 (randomly varying block sizes of 4-6; stratified by country) to 7 day or 14 day bladder catheterisation (via a random allocation sequence computer generated centrally by WHO). Outcome assessors were not masked to treatment assignment. The primary outcome was fistula repair breakdown, on the basis of dye test results, any time between 8 days after catheter removal and 3 months after surgery. The non-inferiority margin was 10%, assessed in the per-protocol population. This trial is registered with ClinicalTrials.gov, number NCT01428830. FINDINGS: We randomly allocated 524 participants between March 7, 2012, and May 6, 2013; 261 in the 7 day group and 263 in the 14 day group. In the per-protocol analysis, ten (4%) of 250 patients had repair breakdown in the 7 day group (95% CI 2-8) compared with eight (3%) of 251 (2-6) in the 14 day group (risk difference 0·8% [95% CI -2·8 to 4·5]), meeting the criteria for non-inferiority. INTERPRETATION: 7 day bladder catheterisation after repair of simple fistula is non-inferior to 14 day catheterisation and could be used for management of women after repair of simple fistula with no evidence of a significantly increased risk of repair breakdown, urinary retention, or residual incontinence up to 3 months after surgery. FUNDING: US Agency for International Development.

The reliability of a segmentation methodology for assessing intramuscular adipose tissue and other soft-tissue compartments of lower leg MRI images.

OBJECTIVE: Determine the reliability of a magnetic resonance (MR) image segmentation protocol for quantifying intramuscular adipose tissue (IntraMAT), subcutaneous adipose tissue, total muscle and intermuscular adipose tissue (InterMAT) of the lower leg. MATERIALS AND METHODS: Ten axial lower leg MRI slices were obtained from 21 postmenopausal women using a 1 Tesla peripheral MRI system. Images were analyzed using sliceOmatic™ software. The average cross-sectional areas of the tissues were computed for the ten slices. Intra-rater and inter-rater reliability were determined and expressed as the standard error of measurement (SEM) (absolute reliability) and intraclass coefficient (ICC) (relative reliability). RESULTS: Intra-rater and inter-rater reliability for IntraMAT were 0.991 (95% confidence interval [CI] 0.978-0.996, p < 0.05) and 0.983 (95% CI 0.958-9.993, p < 0.05), respectively. For the other soft tissue compartments, the ICCs were all >0.90 (p < 0.05). The absolute intra-rater and inter-rater reliability (expressed as SEM) for segmenting IntraMAT were 22.19 mm(2) (95% CI 16.97-32.04) and 78.89 mm(2) (95% CI 60.36-113.92), respectively. CONCLUSION: This is a reliable segmentation protocol for quantifying IntraMAT and other soft-tissue compartments of the lower leg. A standard operating procedure manual is provided to assist users, and SEM values can be used to estimate sample size and determine confidence in repeated measurements in future research.

Quantifying fat and lean muscle in the lower legs of women with knee osteoarthritis using two different MRI systems.

Decreased muscle mass and increased fat mass are commonly seen in the thighs of individuals with knee osteoarthritis (OA). Despite the role of calf muscles in activities of daily living and knee mechanics, little work has investigated calf changes in knee OA. Unlike the thigh, muscle and fat in the lower leg can be imaged using a peripheral magnetic resonance imaging (MRI) scanner. We aimed to assess agreement between subcutaneous fat, intermuscular fat (IMF), intramuscular fat (intraMF), and lean muscle volumes acquired using a peripheral 1.0T as compared to a reference whole-body 3.0T MRI scanner. A calf MRI scan from each scanner was acquired from twenty women >55 years with knee OA. The different tissues were segmented on each of ten axial slices for every participant using SliceOmatic 5.0 (Tomovision, Magog, QC). Tissue volumes were determined for each outcome. Agreement between tissue volumes from the two scanners was assessed using intraclass correlation (ICC(2,1)) coefficients, standard error, and Bland-Altman plots. Agreement between tissue volumes was strong to very strong, with ICCs ranging from 0.842 to 0.991 for all outcomes. However, wide confidence intervals for IMF and intraMF suggest there is less confidence in agreement with segmentation of images from the 1.0T scanner generally underestimating fat volume relative to the 3.0T scanner. The 3.0T's superior between-tissue contrast likely resulted in more accurate segmentation of IMF and intraMF compared to the 1.0T scanner. Comparisons of tissue volume between studies using different scanners/sequences should be interpreted cautiously.