Bone marrow lesions and magnetic resonanceImaging–detected structural abnormalities in patients with midfoot pain and osteoarthritis: A cross-sectional study

To compare magnetic resonance imaging (MRI)–detected structural abnormalities in patients withsymptomatic midfoot osteoarthritis (OA), patients with persistent midfoot pain, and asymptomatic controls, and toexplore the association between MRI features, pain, and foot-related disability. One hundred seven adults consisting of 50 patients with symptomatic and radiographically confirmedmidfoot OA, 22 adults with persistent midfoot pain but absence of radiographic OA, and 35 asymptomatic adultsunderwent 3T MRI of the midfoot and clinical assessment. MRIs were read for the presence and severity of abnormal-ities (bone marrow lesions [BMLs], subchondral cysts, osteophytes, joint space narrowing [JSN], effusion-synovitis,tenosynovitis, and enthesopathy) using the Foot Osteoarthritis MRI Score. Pain and foot-related disability wereassessed with the Manchester Foot Pain and Disability Index. The severity sum score of BMLs in the midfoot was greater in patients with midfoot pain and no signs ofOA on radiography compared to controls (P= 0.007), with a pattern of involvement in the cuneiform–metatarsal jointssimilar to that in patients with midfoot OA. In univariable models, BMLs (ρ= 0.307), JSN (ρ= 0.423), and subchondralcysts (ρ= 0.302) were positively associated with pain (P< 0.01). In multivariable models, MRI abnormalities were notassociated with pain and disability when adjusted for covariates. In individuals with persistent midfoot pain but no signs of OA on radiography, MRIfindings suggestedan underrecognized prevalence of OA, particularly in the second and third cuneiform–metatarsal joints, where BMLpatterns were consistent with previously recognized sites of elevated mechanical loading. Joint abnormalities werenot strongly associated with pain or foot-related disability

Improving Benefit-harm Assessment of Therapies from the Patient Perspective: OMERACT Premeeting Toward Consensus on Core Sets for Randomized Controlled Trials

Objective: Outcome Measures in Rheumatology (OMERACT) convened a premeeting in 2018 to bring together patients, regulators, researchers, clinicians, and consumers to build upon previous OMERACT drug safety work, with patients fully engaged throughout all phases. Methods: Day 1 included a brief introduction to the history of OMERACT and methodology, and an overview of current efforts within and outside OMERACT to identify patient-reported medication safety concerns. On Day 2, two working groups presented results; after each, breakout groups were assembled to discuss findings. Results: Five themes pertaining to drug safety measurement emerged. Conclusion: Current approaches have failed to include data from the patient’s perspective. A better understanding of how individuals with rheumatic diseases view potential benefits and harms of therapies is essential

Rents, knowledge and neo-structuralism: transforming the productive matrix in Ecuador

This paper explores the relationship between ground rent, production and knowledge in Ecuador’s neo-structuralist, state-led project to transform the productive matrix. Based upon insights from the Marxian approach to the critique of political economy, we interrogate how neo-structuralism has conceptualised the relationship between ‘natural resource income’ and ‘knowledge-based’ economic development. The paper argues that a rent-theoretical perspective, which takes seriously the regional unfolding of uneven geographical development in Latin America, can highlight the limits of a national development plan conceived according to the logic of Schumpeterian efficiency. In doing so, the paper identifies the contradictory relationship between natural resource exports, state-led ‘knowledge’-based development and capital accumulation. On this basis the paper offers a historically and empirically informed critical analysis of selective import substitution industrialisation and vanguard science and technology strategies designed to transition Ecuador away from primary resource dependence

Developing an outcome measures in rheumatology (OMERACT) core set of outcome measures for foot and ankle disorders in rheumatic and musculoskeletal diseases (COMFORT): Core domain set study protocol

Background: Foot and ankle involvement is common in rheumatic and musculoskeletal diseases (RMDs). High-quality evidence is lacking to determine the effectiveness of treatments for these disorders. Heterogeneity in the outcomes used across clinical trials and observational studies hinders the ability to compare findings, and some outcomes are not always meaningful to patients and end-users. The Core set of Outcome Measures for FOot and ankle disorders in RheumaTic and musculoskeletal diseases (COMFORT) study aims to develop a core outcome set (COS) for use in all trials of interventions for foot and ankle disorders in RMDs. This protocol addresses core outcome domains (what to measure) only. Future work will focus on core outcome measurement instruments (how to measure). Methods: COMFORT: Core Domain Set is a mixed-methods study involving the following: (i) identification of important outcome domains through literature reviews, qualitative interviews and focus groups with patients and (ii) prioritisation of domains through an online, modified Delphi consensus study and subsequent consensus meeting with representation from all stakeholder groups. Findings will be disseminated widely to enhance uptake. Conclusions: This protocol details the development process and methodology to identify and prioritise domains for a COS in the novel area of foot and ankle disorders in RMDs. Future use of this standardised set of outcome domains, developed with all key stakeholders, will help address issues with outcome variability. This will facilitate comparing and combining study findings, thus improving the evidence base for treatments of these conditions. Future work will identify suitable outcome measurement instruments for each of the core domains. Trial registration: This study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, as of June 2022: https://www.comet-initiative.org/Studies/Details/2081

Osteoarthritis Preoperative Package for care of Orthotics, Rehabilitation, Topical and oral agent Usage and Nutrition to Improve ouTcomes at a Year (OPPORTUNITY); a feasibility study protocol for a randomised controlled trial

BackgroundPatients’ pre-operative health and physical function is known to influence their post-operative outcomes. In patients with knee osteoarthritis, pharmacological and non-pharmacological options are often not optimised prior to joint replacement. This results in some patients undergoing surgery when they are not as fit as they could be. The aim of this study is to assess the feasibility and acceptability of a pre-operative package of non-operative care versus standard care prior to joint replacement.Methods/designThis is a multicentre, randomised controlled feasibility trial of patients undergoing primary total knee replacement for osteoarthritis. Sixty patients will be recruited and randomised (2:1) to intervention or standard care arms. Data will be collected at baseline (before the start of the intervention), around the end of the intervention period and a minimum of 90 days after the planned date of surgery. Adherence will be reviewed each week during the intervention period (by telephone or in person). Participants will be randomised to a pre-operative package of non-operative care or standard care. The non-operative care will consist of (1) a weight-loss programme, (2) a set of exercises, (3) provision of advice on analgesia use and (4) provision of insoles. The intervention will be started as soon as possible after patients have been added to the waiting list for joint replacement surgery to take advantage of the incentive for behavioural change that this will create. The primary outcomes of this study are feasibility outcomes which will indicate whether the intervention and study protocol is feasible and acceptable and whether a full-scale effectiveness trial is warranted.The following will be measured and used to inform study feasibility: rate of recruitment, rate of retention at 90-day follow-up review after planned surgery date, and adherence to the intervention estimated through review questionnaires and weight change (for those receiving the weight-loss aspect of intervention). In addition the following information will be assessed qualitatively: analysis of qualitative interviews exploring acceptability, feasibility, adherence and possible barriers to implementing the intervention, and acceptability of the different outcome measures.DiscussionThe aims of the study specifically relate to testing the feasibility and acceptability of the proposed effectiveness trial intervention and the feasibility of the trial methods.This study forms the important first step in developing and assessing whether the intervention has the potential to be assessed in a future fully powered effectiveness trial. The findings will also be used to refine the design of the effectiveness trial.Trial registrationISRCTN registry, ID: ISRCTN96684272. Registered on 18 April 2018

Pain Reduction with Oral Methotrexate in Knee Osteoarthritis; a Randomized Placebo-Controlled Clinical Trial

Background: Treatments for osteoarthritis are limited. Previous small studies suggest the anti-rheumatic drug methotrexate may be a potential treatment for osteoarthritis pain. Objective: To assess symptomatic benefits of methotrexate in knee osteoarthritis. Design: A multi-center, randomized, double-blind, placebo-controlled trial conducted between 13 June 2014 and 8 September 2017. Setting: Fifteen United Kingdom secondary-care musculoskeletal clinics. Participants: 207 participants with symptomatic, radiographic knee osteoarthritis, knee pain (severity ≥4/10) on most days in the last 3-months, with inadequate response to current medication were approached for inclusion. Interventions: Participants were randomized 1:1 to once-weekly oral methotrexate (6-week escalation 10mg-25mg) or matched placebo over 12-months and continued usual analgesia. Measurements: The primary endpoint was average knee pain (numerical rating scale (NRS) 0-10) at 6-months, with 12-month follow-up to assess longer-term response. Secondary endpoints included knee stiffness and function outcomes, and adverse events. Results: 155 participants (64% women, mean age 60.9 years, 50% Kellgren-Lawrence Grade 3-4) were randomized to methotrexate (n=77) or placebo (n=78). Follow-up was 86% (n=134; MTX 66, Placebo 68) at 6-months. Mean(SD) knee pain reduced from 6.4(1.80) at baseline to 5.1(2.32) at 6-months in the MTX group, and from 6.8(1.62) to 6.2(2.30) in the placebo group. The primary intention-to-treat analysis revealed a statistically significant pain reduction of 0.79 NRS points in favour of MTX (95%CI[0.08-1.51];p=0.030). There were also statistically significant treatment-group differences in favour of MTX at 6-months for WOMAC stiffness (0.60 points, 95%CI[0.01-1.18];p=0.045) and function (5.01 points, 95%CI[1.29-8.74],p=0.008). Treatment-compliance analysis supported a dose-response effect. Four unrelated serious adverse events were reported (methotrexate:2, placebo:2). Limitations: Not permitting oral methotrexate to be changed to subcutaneous delivery for intolerance. Conclusions: Oral methotrexate added to usual medications demonstrated statistically significant reduction in knee osteoarthritis pain, stiffness and function at 6-months. Funding Source: Versus Arthritis 20186. Trial registration number: ISRCTN77854383 (https://doi.org/10.1186/ISRCTN77854383); EudraCT: 2013-001689-41 (https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number%3A2013-001689-41

State capture and decorporatization of financial elites in Ecuador

Objetivo/contexto: El artículo analiza la relación entre el Estado y las élites financieras en Ecuador durante el gobierno de Rafael Correa (2007-2014), enmarcado en lo que se conoce como giro a la izquierda. Este gobierno emprendió una lucha descorporativizadora para desacoplar la gestión estatal de los intereses privados que habían capturado al Estado durante el ciclo neoliberal. Esto implicó dos movimientos simultáneos: quebrar la institucionalidad vigente en distintos ámbitos de política pública (educación, finanzas, salud, medios de comunicación, entre otros) regentados por actores de veto con intereses particulares y, al mismo tiempo, edificar una nueva institucionalidad capaz de responder a intereses y demandas más amplias, en una clave democrática e inclusiva. Metodología: La exploración empírica de este caso se efectuó con una metodología cualitativa basada en el análisis hemerográfico y normativo y el rastreo de procesos, lo cual permitió ofrecer evidencia sobre mecanismos de captura y descorporativización del Estado, en el marco de gobiernos cuyos adversarios predilectos son las élites económicas comprometidas con el neoliberalismo. Conclusiones: La reconfiguración institucional llevada adelante por la Revolución Ciudadana en el ámbito de las finanzas consiguió mayores márgenes de autonomía estatal, a través de nuevos diseños institucionales de organismos del sistema financiero, como las Juntas Monetaria y Bancaria, para evitar que los intereses privados de los banqueros permeen la gestión estatal. Originalidad: El texto aportó elementos para suplir el vacío que se encuentra en los estudios sobre élites en América Latina y su relación con el Estado, específicamente, acerca de los mecanismos de captura y “des-captura” de la gestión estatal.Objective/context: The article analyzes the relationship between the State and financial elites in Ecuador during the government of Rafael Correa (2007-2014), framed by what is known as the turn to the left. This government carried out a decorporatizing fight to delink state management from private interests that had captured the State during the neoliberal cycle. This entailed two simultaneous movements: breaking the institutionality in force in different spheres of public policy (education, finance, health, communications media, among others) governed by actors with veto powers and special interests and, at the same time, building a new institutionality capable of responding to wider interests and demands, within a democratic and inclusive spirit. Methodology: The empirical exploration of this case was performed with a qualitative methodology based on an analysis of the press and regulations and the tracking of processes, which allowed offering evidence regarding the mechanisms for the capture and decorporatization of the State, within the framework of governments whose favorite adversaries are the economic elites committed to neoliberalism. Conclusions: The institutional reconfiguration carried out by the Citizen’s Revolution within the sphere of finance achieved greater margins of state autonomy, through new institutional designs of financial system bodies, such as the Monetary and Banking Boards, to keep the private interests of bankers from permeating state management. Originality: The text contributed elements to bridge the gap found in studies on elites in Latin America and their relationship with the State, specifically, regarding the mechanisms for the capture and “de-capture” of state management.Fil: Coronel, Valeria. Facultad Latinoamericana de Ciencias Sociales; EcuadorFil: Stoessel, Soledad. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata. Instituto de Investigaciones en Humanidades y Ciencias Sociales. Universidad Nacional de La Plata. Facultad de Humanidades y Ciencias de la Educación. Instituto de Investigaciones en Humanidades y Ciencias Sociales; ArgentinaFil: Guanche, Julio César. Facultad Latinoamericana de Ciencias Sociales; EcuadorFil: Cadahia, María Luciana. Pontificia Universidad Javeriana; Colombi

BHPR research: qualitative1. Complex reasoning determines patients' perception of outcome following foot surgery in rheumatoid arhtritis

Background: Foot surgery is common in patients with RA but research into surgical outcomes is limited and conceptually flawed as current outcome measures lack face validity: to date no one has asked patients what is important to them. This study aimed to determine which factors are important to patients when evaluating the success of foot surgery in RA Methods: Semi structured interviews of RA patients who had undergone foot surgery were conducted and transcribed verbatim. Thematic analysis of interviews was conducted to explore issues that were important to patients. Results: 11 RA patients (9 ♂, mean age 59, dis dur = 22yrs, mean of 3 yrs post op) with mixed experiences of foot surgery were interviewed. Patients interpreted outcome in respect to a multitude of factors, frequently positive change in one aspect contrasted with negative opinions about another. Overall, four major themes emerged. Function: Functional ability & participation in valued activities were very important to patients. Walking ability was a key concern but patients interpreted levels of activity in light of other aspects of their disease, reflecting on change in functional ability more than overall level. Positive feelings of improved mobility were often moderated by negative self perception ("I mean, I still walk like a waddling duck”). Appearance: Appearance was important to almost all patients but perhaps the most complex theme of all. Physical appearance, foot shape, and footwear were closely interlinked, yet patients saw these as distinct separate concepts. Patients need to legitimize these feelings was clear and they frequently entered into a defensive repertoire ("it's not cosmetic surgery; it's something that's more important than that, you know?”). Clinician opinion: Surgeons' post operative evaluation of the procedure was very influential. The impact of this appraisal continued to affect patients' lasting impression irrespective of how the outcome compared to their initial goals ("when he'd done it ... he said that hasn't worked as good as he'd wanted to ... but the pain has gone”). Pain: Whilst pain was important to almost all patients, it appeared to be less important than the other themes. Pain was predominately raised when it influenced other themes, such as function; many still felt the need to legitimize their foot pain in order for health professionals to take it seriously ("in the end I went to my GP because it had happened a few times and I went to an orthopaedic surgeon who was quite dismissive of it, it was like what are you complaining about”). Conclusions: Patients interpret the outcome of foot surgery using a multitude of interrelated factors, particularly functional ability, appearance and surgeons' appraisal of the procedure. While pain was often noted, this appeared less important than other factors in the overall outcome of the surgery. Future research into foot surgery should incorporate the complexity of how patients determine their outcome Disclosure statement: All authors have declared no conflicts of interes