Facilitators and barriers for vaccination in patients with inflammatory rheumatic musculoskeletal diseases: a prospective cohort study.

INTRODUCTION: To identify facilitators and barriers towards vaccination in general and specifically against pneumococci, influenza and SARS-CoV-2 in patients with rheumatic musculoskeletal diseases (RMD). METHODS: Between February and April 2021, consecutive patients with RMD were asked to complete a structured questionnaire on general knowledge about vaccination, personal attitudes and perceived facilitators and barriers towards vaccination. General facilitators (n=12) and barriers (n=15) and more specific ones for vaccination against pneumococci, influenza and SARS-CoV-2 were assessed. Likert scales had four response options: from 1 (completely disagree) to 4 (completely agree). Patient and disease characteristics, their vaccination records and attitudes towards vaccination against SARS-CoV-2 were assessed. RESULTS: 441 patients responded to the questionnaire. Knowledge about vaccination was decent in ≥70% of patients, but <10% of patients doubted its effectiveness. Statements on facilitators were generally more favourable than on barriers. Facilitators for SARS-CoV-2 vaccination were not different from vaccination in general. Societal and organisational facilitators were more often named than interpersonal or intrapersonal facilitators. Most patients indicated that recommendations of their healthcare professional would encourage them to be vaccinated-without preference for general practitioner or rheumatologists. There were more barriers towards SARS-CoV-2 vaccination than to vaccination in general. Intrapersonal issues were most frequently reported as a barrier. Statistically significant differences in response patterns to nearly all barriers between patients classified as definitely willing, probably willing and unwilling to receive SARS-CoV-2 vaccines were noted. DISCUSSION: Facilitators towards vaccination were more important than barriers. Most barriers against vaccination were intrapersonal issues. Societal facilitators identified support strategies in that direction.

Defining a Patient-Centred Core Outcome Domain Set for the Assessment of Hearing Rehabilitation With Clients and Professionals.

Background: A variety of outcome domains are currently measured for the assessment of hearing rehabilitation. To date, there is no consensus about which outcome domains should be measured, when they should be measured, and how they should be measured. In addition, most studies seeking to develop core outcome sets and measures for hearing rehabilitation services have primarily focussed on the opinions and expertise of researchers, and, to a lesser extent, clinicians, rather than also involving clients of those services. The principles of experience-based co-design suggest that health services, researchers, and policymakers should come together with clients and their families to design health services and define what metrics should be used for their success. Objectives: This study aimed to seek views and consensus from a range of key stakeholders to define which client-centred self-report outcome domains should be measured, when they should be measured, and how they should be measured, in a national publicly funded hearing rehabilitation scheme. In addition, the study aimed to identify current and future potential mechanisms and systems to standardise the collection of data and reporting of outcomes, to enable comparison across clients and hearing service providers. Methods: Two stakeholder groups participated in a three-round online Delphi process: (1) 79 professional stakeholders involved in the delivery of hearing services in Australia, and (2) 64 hearing rehabilitation services' clients identified by not-for-profit consumer organisations. An initial set of in-person workshops scoped the key issues upon which to develop the initial open-ended questions and subsequent Likert-scale statements addressing these issues. These statements were then distributed to both groups in an online survey. The respondent ratings were summarised, and the summary was returned to respondents along with a second round of the survey. This process was then repeated once more. The five most important outcome domains from both groups were then combined, and a consensus workshop of seven professionals and three client advocates agreed on the top four ranked domains. Results: A range of potential outcome domains were identified as relevant indicators of successful hearing rehabilitation. Communication ability, personal relationships, wellbeing, and participation restrictions were identified as a core outcome domain set that should be measured as a minimum for patients receiving hearing rehabilitation. There was little agreement on the preferred timepoints for collection of outcome measures, with respondents expressing the view that this should be established by research once a set of outcome measures has been selected. However, there was broad agreement that measurements of these domains should be collected at baseline (before the provision of hearing rehabilitation) and no earlier than 3 months following the completion of rehabilitation. Potential benefits and issues with the development of a national outcomes database/collection system were also identified and prioritised, with participants highlighting the importance of valid, high-quality, trustworthy, and comprehensive data collection. Conclusion: These results provide a Core Outcome Domain Set for the self-reported evaluation of hearing rehabilitation and provide important background information for the design of methods to implement them across hearing healthcare systems. However, the wide range of outcome domains identified as potentially providing important additional information and the lack of specific measures to address these domains strongly suggest that there is still more research to be done. Ongoing stakeholder engagement will continue to be vital for future implementation. In addition, further research is required to determine the optimal time following hearing rehabilitation to utilise any particular outcome measure.

Benefit of burosumab in adults with X-linked hypophosphataemia (XLH) is maintained with long-term treatment.

OBJECTIVES: To report the impact of continued burosumab treatment on clinical laboratory tests of efficacy, patient-reported outcomes (PROs) and ambulatory function in adults with X-linked hypophosphataemia who continued from a 96-week phase 3 study into a 48-week open-label extension. METHODS: Eligible participants from the phase 3 study continued on the burosumab regimen received at the end of the phase 3 study for a further 48 weeks (n=31). Some (not all) received compassionate burosumab treatment between the two studies (a period of 6-18 months). The primary efficacy outcome was fasting serum phosphate concentration; secondary outcomes were serum 1,25 dihydroxyvitamin D concentration, renal phosphate reabsorption, PROs and ambulatory function. RESULTS: Improvements in fasting serum phosphate, serum 1,25 dihydroxyvitamin D and renal phosphate reabsorption at 96 weeks were maintained through the 48-week extension. Improvements were also maintained in stiffness and physical function measured using the Western Ontario and McMaster Universities Osteoarthritis Index, pain and fatigue endpoints measuring using the Brief Pain Inventory short-form and Brief Pain Inventory, respectively, and in ambulatory function (6-Minute Walk Test).A post-hoc exploratory analysis exploring outcomes in participants who discontinued burosumab treatment between the studies (n=7) and those who received at least one dose (n=23) indicated that the benefits of burosumab on clinical laboratory tests of efficacy, PROs and ambulatory function may be lost when treatment is interrupted but recover over time when treatment is reinstated. CONCLUSION: Continued treatment with burosumab appears necessary for sustained clinical benefit. TRIAL REGISTRATION NUMBERS: Phase 3: NCT02526160; open-label extension: NCT03920072.

Outcome of COVID-19 in patients with rheumatic and inflammatory diseases treated with mycophenolic acid: data from the French RMD COVID-19 cohort.

BACKGROUND: Patients with inflammatory rheumatic and musculoskeletal diseases (iRMD) receiving mycophenolic acid (MPA) may have a less favourable outcome from COVID-19 infection. Our aim was to investigate whether MPA treatment is associated with severe infection and/or death. METHODS: IRMD patients with and without MPA treatment with highly suspected/confirmed COVID-19 were included in this observational multicentre study. The primary outcome was death rate from COVID-19 with secondary objectives to determine the severity of infection and length of hospital stay. Outcome comparisons were made using regression models with and without adjustment on prespecified confounding factors. ORs, sub-HR (sHR) and 95% CIs were calculated using patients not treated with MPA as a reference group. RESULTS: Of the 1977 patients, 1928 were not treated with MPA (393 were MPA eligible), and 49 patients were treated with MPA. MPA-treated patients had more severe disease, longer hospital stays and higher death rate from COVID-19 than non-MPA patients (OR 8.02 (95% CI 3.35 to 19.20), p<0.001; sHR 0.57 (95% CI 0.33 to 0.98), p=0.040; OR 11.58 (95% CI 4.10 to 32.69), p<0.001). In adjusted analyses, however, no outcome was independently associated with MPA treatment. Death rate, severity and length of hospital stay of MPA-treated patients were not significantly different from those of not treated but MPA-eligible patients. CONCLUSION: MPA therapy is not associated with a more severe COVID-19 infection. However, due to increased vulnerability of developing a severe form of COVID-19, careful consideration should be taken with iRMD patients likely to be treated with MPA. TRIAL REGISTRATION NUMBER: NCT04353609.

Factors associated with severe COVID-19 in people with idiopathic inflammatory myopathy: results from the COVID-19 Global Rheumatology Alliance physician-reported registry.

OBJECTIVES: To investigate factors associated with severe COVID-19 in people with idiopathic inflammatory myopathy (IIM). METHODS: Demographic data, clinical characteristics and COVID-19 outcome severity of adults with IIM were obtained from the COVID-19 Global Rheumatology Alliance physician-reported registry. A 3-point ordinal COVID-19 severity scale was defined: (1) no hospitalisation, (2) hospitalisation (and no death) and (3) death. ORs were estimated using multivariable ordinal logistic regression. Sensitivity analyses were performed using a 4-point ordinal scale: (1) no hospitalisation, (2) hospitalisation with no oxygen (and no death), (3) hospitalisation with oxygen/ventilation (and no death) and 4) death. RESULTS: Of 348 patients, 48% were not hospitalised, 39% were hospitalised (and did not die) and 13% died. Older age (OR=1.59/decade, 95% CI 1.31 to 1.91), high disease activity (OR=3.50, 95% CI 1.25 to 9.83; vs remission), ≥2 comorbidities (OR=2.63, 95% CI 1.39 to 4.98; vs none), prednisolone-equivalent dose >7.5 mg/day (OR=2.40, 95% CI 1.09 to 5.28; vs no intake) and exposure to rituximab (OR=2.71, 95% CI 1.28 to 5.72; vs conventional synthetic disease-modifying antirheumatic drugs only) were independently associated with severe COVID-19. In addition to these variables, in the sensitivity analyses, male sex (OR range: 1.65-1.83; vs female) was also significantly associated with severe outcomes, while COVID-19 diagnosis after 1 October 2020 (OR range: 0.51-0.59; vs on/before 15 June 2020) was significantly associated with less severe outcomes, but these associations were not significant in the main model (OR=1.57, 95% CI 0.95 to 2.59; and OR=0.61, 95% CI 0.37 to 1.00; respectively). CONCLUSIONS: This is the first large registry data on outcomes of COVID-19 in people with IIM. Older age, male sex, higher comorbidity burden, high disease activity, prednisolone-equivalent dose >7.5 mg/day and rituximab exposure were associated with severe COVID-19. These findings will enable risk stratification and inform management decisions for patients with IIM.

Multispecialty multidisciplinary input into comorbidities along with treatment optimisation in heart failure reduces hospitalisation and clinic attendance.

AIMS: Heart failure (HF) is associated with comorbidities which independently influence treatment response and outcomes. This retrospective observational study (January 2020-June 2021) analysed the impact of monthly HF multispecialty multidisciplinary team (MDT) meetings to address management of HF comorbidities and thereby on provision, cost of care and HF outcomes. METHODS: Patients acted as their own controls, with outcomes compared for equal periods (for each patient) pre (HF MDT) versus post-MDT (multispecialty) meeting. The multispecialty MDT comprised HF cardiologists (primary, secondary, tertiary care), HF nurses, nephrologist, endocrinologist, palliative care, chest physician, pharmacist, clinical pharmacologist and geriatrician. Outcome measures were (1) all-cause hospitalisations, (2) outpatient clinic attendances and (3) cost. RESULTS: 334 patients (mean age 72.5±11 years) were discussed virtually through MDT meetings and follow-up duration was 13.9±4 months. Mean age-adjusted Charlson Comorbidity Index was 7.6±2.1 and Rockwood Frailty Score 5.5±1.6. Multispecialty interventions included optimising diabetes therapy (haemoglobin A1c-HbA1c pre-MDT 68±11 mmol/mol vs post-MDT 61±9 mmol/mol; p<0.001), deprescribing to reduce anticholinergic burden (pre-MDT 1.85±0.4 vs 1.5±0.3 post-MDT; p<0.001), initiation of renin-angiotensin aldosterone system inhibitors in HF with reduced ejection fraction (HFrEF) with advanced chronic kidney disease (9% pre vs 71% post-MDT; p<0.001). Other interventions included potassium binders, treatment of anaemia, falls assessment, management of chest conditions, day-case ascitic, pleural drains and palliative support. Total cost of funding monthly multispecialty meetings was £32 400 and resultant 64 clinic appointments cost £9600. The post-MDT study period was associated with reduction in 481 clinic appointments (cost saving £72150) and reduced all-cause hospitalisations (pre-MDT 1.1±0.4 vs 0.6±0.1 post-MDT; p<0.001), reduction of 1586 hospital bed-days and cost savings of £634 400. Total cost saving to the healthcare system was £664 550. CONCLUSION: HF multispecialty virtual MDT model provides integrated, holistic care across all healthcare tiers for management of HF and associated comorbidities. This approach is associated with reduced clinic attendances and all-cause hospitalisations, leading to significant cost savings.

Was rooming-in a safe approach to newborns from SARS-CoV-2 positive mothers?

Introduction: Since the emergence of coronavirus disease 2019, known as COVID-19, there are limited data describing the risks and specific effects of severe acute respiratory syndrome coronavirus 2, or SARS-CoV-2, in pregnant women and their neonates. To date, there is scarce evidence of in utero transmission, and the risk of perinatal transmission and consequent neonate risk of developing COVID-19 during the perinatal period are also unknown. Methods: Since April 2020, universal screening of all pregnant women presenting in labor has been implemented in our hospital. To those who are positive for SARS-CoV-2, the possibility to room-in with the neonate is given. Neonates are tested for SARS-CoV-2 within the first 24 hours and again at 48 hours of life. We made a prospective cohort analysis of all neonates born of mothers positive for SARS-CoV-2 in our hospital from April to November 2020. Demographics, neonatal and maternal symptoms at the delivery, during hospitalization and once discharged, perinatal routine care and SARS-CoV-2 reverse transcription polymerase chain reaction results were studied. Results: We analyzed 23 mothers positive for SARS-CoV-2. Only eight declared having symptoms, mainly headaches, anosmia, and ageusia/dysgeusia. The 23 neonates were negative for SARS-CoV-2 in both reverse transcription polymerase chain reaction tests performed. All of the neonates were born and remained asymptomatic during the 14 days of surveillance time and all of them were breastfed. Discussion: According to our results, rooming-in was safe for newborns of SARS-CoV-2 positive mothers since there was no evidence of perinatal infection. This practice is a well-known way to promote early breastfeeding and encourage maternal-infant bonding. © Author(s) (or their employer(s)) and Portuguese Journal of Pediatrics 2021.

Apparent Discordance Between the Epidemiology of COVID-19 and Recommended Outcomes and Treatments: A Scoping Review.

OBJECTIVE: Many survivors of COVID-19 experience ongoing signs and symptoms affecting multiple body systems that impair function and negatively affect participation and quality of life. The purpose of this review was to identify and synthesize outpatient rehabilitation assessment and treatment recommendations for adults in postacute COVID-19 stages. METHODS: MEDLINE (Ovid), EMBASE (Ovid), Central, CINAHL, and Scopus were searched from January 1, 2020, to December 7, 2020. Teams of 2 reviewers independently assessed study eligibility and extracted data. All study designs that included rehabilitation recommendations were included. Study design, country, study population, purpose, and rehabilitation recommendations were recorded. Select questions from the Appraisal of Guidelines for Research and Evaluation instrument were used to evaluate the quality of consensus guidelines. RESULTS: Forty-eight articles fit the inclusion and exclusion criteria (11 systematic reviews, 1 scoping review, 6 original research studies, 4 consensus guidelines, 26 narrative reviews, and editorials/commentaries). Recommended outcomes included exercise tolerance, respiratory function, muscle strength, and activities of daily living or functional independence. Recommended treatments included respiratory rehabilitation, exercise therapy, education, psychological support, activities of daily living and gait training, traditional Chinese medicine, and cognitive and vocational rehabilitation. CONCLUSION: There were incongruities between what is known about postacute COVID-19 and what was recommended in the literature. Given the relatively large proportion of survivors who experience ongoing symptomatic COVID-19 or post-COVID-19 syndrome, it is important to quickly develop tools for self-management and access to rehabilitation specialists in multidisciplinary teams. IMPACT: Physical therapists, occupational therapists, and respiratory therapists have an important role to play. Clinicians should focus on epidemiological evidence and emerging information on late sequelae of COVID-19 to inform rehabilitation programming and future research.

Digital crowdsourcing: unleashing its power in rheumatology.

The COVID-19 pandemic forces the whole rheumatic and musculoskeletal diseases community to reassemble established treatment and research standards. Digital crowdsourcing is a key tool in this pandemic to create and distil desperately needed clinical evidence and exchange of knowledge for patients and physicians alike. This viewpoint explains the concept of digital crowdsourcing and discusses examples and opportunities in rheumatology. First experiences of digital crowdsourcing in rheumatology show transparent, accessible, accelerated research results empowering patients and rheumatologists.