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ObjectivesThe aims of this study were to update the evidence on the incidence and prevalence rates of vaccine preventable infections (VPI) in patients with autoimmune inflammatory rheumatic diseases (AIIRD) and compare the data to the general population when available.MethodsA literature search was performed using Medline, Embase and Cochrane library (October 2009 to August 2018). The primary outcome was the incidence or prevalence of VPI in the adult AIIRD population. Meta-analysis was performed when appropriate.ResultsSixty-three publications out of 3876 identified records met the inclusion criteria: influenza (n=4), pneumococcal disease (n=7), hepatitis B (n=10), herpes zoster (HZ) (n=29), human papillomavirus (HPV) infection (n=13). An increased incidence of influenza and pneumococcal disease was reported in patients with AIIRD. HZ infection-pooled incidence rate ratio (IRR) was 2.9 (95% CI 2.4 to 3.3) in patients with AIIRD versus general population. Among AIIRD, inflammatory myositis conferred the highest incidence rate (IR) of HZ (pooled IRR 5.1, 95% CI 4.3 to 5.9), followed by systemic lupus erythematosus (SLE) (pooled IRR 4.0, 95% CI 2.3 to 5.7) and rheumatoid arthritis (pooled IRR 2.3, 95% CI 2.1 to 2.6). HPV infection-pooled prevalence ratio was 1.6, 95% CI 0.7 to 3.4 versus general population, based on studies mainly conducted in the SLE population in Latin America and Asia. Pooled prevalence of hepatitis B surface antigen and hepatitis B core antibody in patients with AIIRD was similar to the general population, 3%, 95% CI 1% to 5% and 15%, 95% CI 7% to 26%, respectively.ConclusionCurrent evidence shows an increased risk of VPI in patients with AIIRD, emphasising that prevention of infections is essential in these patients.

To explore the perspectives of general practitioners (GPs) on facilitators and barriers in diagnosing rheumatoid arthritis (RA). Qualitative study based on focus group interviews, and using latent thematic analysis. General practices from Central Region Denmark. Eleven GPs participated in three different focus groups. Forty percent were female, the mean age was 53 years (range 37-64), and the mean since medical licensing was 16 years (range 5-23). Sixty percent of the GPs worked in an area served by a university hospital, and 40% were served by a regional hospital. Themes describing experiences and reflections about facilitators and barriers in diagnosing Rheumatoid Arthritis. Four themes emerged: (A) If the patient is not a textbook example, (B) The importance of maintaining the gatekeeper function, (C) Difficulties in referral of patients to the rheumatologist, and (D) Laboratory tests-can they be trusted? Barriers were identified in all themes, but facilitators only in A, C, and D. The overarching theme was Like finding a needle in a haystack. The GPs found several barriers for diagnosing RA (symptom awareness, GP's gatekeeper function, suboptimal collaboration with rheumatologists and limitations in laboratory tests). They identified education, more specific tests and better access to rheumatologists as possible facilitators for diagnosing RA. To facilitate earlier referral of suspected RA in general practice and strengthen mutual information and collaboration, future research should focus on these facilitators and barriers. Keypoints Early diagnosis is essential for the prognosis of RA, and the diagnostic process begins in general practice. Suggested facilitators: training courses in interpretation of laboratory tests and the clinical manifestation of RA, and videos on joint examinations. Suggested barriers: compliance with the gatekeeper function, suboptimal collaboration with rheumatologists, limitations of laboratory tests, and diversity of clinical manifestations.

Purpose We examined the association between sociodemographic, personal, and disease-related determinants and referral to a new model of health care that uses patient-reported outcomes (PRO) measures for remote outpatient follow-up (PRO-based follow-up). Methods We conducted a prospective cohort study among outpatients with epilepsy at the Department of Neurology at Aarhus University Hospital, Denmark. Included were all persons aged ≥ 15 years visiting the department for the first time during the period from May 2016 to May 2018. Patients received a questionnaire containing questions about health literacy, self-efficacy, patient activation, well-being, and general health. We also collected data regarding sociodemographic status, labour market affiliation, and co-morbidity from nationwide registers. Associations were analysed as time-to-event using the pseudo-value approach. Missing data were handled using multiple imputations. Results A total of 802 eligible patients were included in the register-based analyses and 411 patients (51%) responded to the questionnaire. The results based on data from registers indicated that patients were less likely to be referred to PRO-based follow-up if they lived alone, had low education or household income, received temporary or permanent social benefits, or if they had a psychiatric diagnosis. The results based on data from the questionnaire indicated that patients were less likely to be referred to PRO-based follow-up if they reported low levels of health literacy, self-efficacy, patient activation, well-being, or general health. Conclusion Both self-reported and register-based analyses indicated that socioeconomically advantaged patients were referred more often to PRO-based follow-up than socioeconomically disadvantaged patients.

The COVID-19 pandemic has become an unprecedented facilitator of rapid telehealth expansion within rheumatology. Due to demographic shifts and workforce shortages in the future, new models of rheumatology care will be expected to emerge, with a growing footprint of telehealth interventions. Telehealth is already being used to monitor patients with rheumatic diseases and initial studies show good results in terms of safety and disease progression. It is being used as a tool for appointment prioritization and triage, and there is good evidence for using telehealth in rehabilitation, patient education and self-management interventions. Electronic patient-reported outcomes (ePROs) offer a number of long-term benefits and opportunities, and a routine collection of ePROs also facilitates epidemiological research that can inform future healthcare delivery. Telehealth solutions should be developed in close collaboration with all stakeholders, and the option of a telehealth visit must not deprive patients of the possibility to make use of a conventional ‘face-to-face’ visit. Future studies should especially focus on optimal models for rheumatology healthcare delivery to patients living in remote areas who are unable to use or access computer technology, and other patient groups at risk for disparity due to technical inequity and lack of knowledge.

AimTo present a systematic literature review (SLR) on efficacy, immunogenicity and safety of vaccination in adult patients with autoimmune inflammatory rheumatic diseases (AIIRD), aiming to provide a basis for updating the EULAR evidence-based recommendations.MethodsAn SLR was performed according to the standard operating procedures for EULAR-endorsed recommendations. Outcome was determined by efficacy, immunogenicity and safety of vaccination in adult patients with AIIRD, including those receiving immunomodulating therapy. Furthermore, a search was performed on the effect of vaccinating household members of patients with AIIRD on the occurrence of vaccine-preventable infections in patients and their household members (including newborns). The literature search was performed using Medline, Embase and the Cochrane Library (October 2009 to August 2018).ResultsWhile most investigated vaccines were efficacious and/or immunogenic in patients with AIIRD, some were less efficacious than in healthy control subjects, and/or in patients receiving immunosuppressive agents. Adverse events of vaccination were generally mild and the rates were comparable to those in healthy persons. Vaccination did not seem to lead to an increase in activity of the underlying AIIRD, but insufficient power of most studies precluded arriving at definite conclusions. The number of studies investigating clinical efficacy of vaccination is still limited. No studies on the effect of vaccinating household members of patients with AIIRD were retrieved.ConclusionEvidence on efficacy, immunogenicity and safety of vaccination in patients with AIIRD was systematically reviewed to provide a basis for updated recommendations.

ObjectiveTo perform a systematic literature review (SLR) on different outcomes of remote care compared with face-to-face (F2F) care, its implementation into clinical practice and to identify drivers and barriers in order to inform a task force formulating the EULAR Points to Consider for remote care in rheumatic and musculoskeletal diseases (RMDs).MethodsA search strategy was developed and run in Medline (PubMed), Embase and Cochrane Library. Two reviewers independently performed standardised data extraction, synthesis and risk of bias (RoB) assessment.ResultsA total of 2240 references were identified. Forty-seven of them fulfilled the inclusion criteria. Remote monitoring (n=35) was most frequently studied, with telephone/video calls being the most common mode of delivery (n=30). Of the 34 studies investigating outcomes of remote care, the majority addressed efficacy and user perception; 34% and 21% of them, respectively, reported a superiority of remote care as compared with F2F care. Time and cost savings were reported as major benefits, technical aspects as major drawback in the 13 studies that investigated drivers and barriers of remote care. No study addressed remote care implementation. The main limitation of the studies identified was the heterogeneity of outcomes and methods, as well as a substantial RoB (50% of studies with high RoB).ConclusionsRemote care leads to similar or better results compared with F2F treatment concerning efficacy, safety, adherence and user perception outcomes, with the limitation of heterogeneity and considerable RoB of the available studies.

Background: Our aim was to investigate whether self-administration of medication (SAM) during hospitalization affects the number of dispensing errors, perceptions regarding medication, and participant satisfaction when compared with nurse-led medication dispensing. Methods: A pragmatic randomized controlled trial was performed in a Danish cardiology unit. Patients aged ⩾ 18 years capable of SAM were eligible for inclusion. Patients were excluded if they did not self-administer medication at home, were not prescribed medication suitable for self-administration, or did not speak Danish. Intervention group participants self-administered their medication. In the control group, medication was dispensed and administered by nurses. The primary outcome was the proportion of dispensing errors collected through modified disguised observation of participants and nurses. Dispensing errors were divided into clinical and procedural errors. Secondary outcomes were explored through telephone calls to determine participant perceptions regarding medication and satisfaction, and finally, deviations in their medication list two weeks after discharge. Results: Significantly fewer dispensing errors were observed in the intervention group, with 100 errors/1033 opportunities for error (9.7%), compared with 132 errors/1028 opportunities for error (12.8%) in the control group. The number of clinical errors was significantly reduced, whereas no difference in procedural errors was observed. At follow up, those who were self-administering medication had fewer concerns regarding their medication, found medication to be less harmful, were more satisfied, preferred this opportunity in the future, and had fewer deviations in their medication list after discharge compared with the control group. Conclusion: In conclusion, the reduced number of dispensing errors in the intervention group, indicate that SAM is safe. In addition, SAM had a positive impact on (a) perceptions regarding medication, thus suggesting increased medication adherence, (b) deviations in medication list after discharge, and (c) participant satisfaction related to medication management at the hospital. Lay Summary Self-administration of medication: a research study of the impact on dispensing errors, perceptions, and satisfaction Background: Our aim was to investigate whether self-administration of medication (SAM) during hospitalization affects the number of dispensing errors, perceptions regarding medication, and participant satisfaction when compared with medication dispensed by nurses. Methods: A research study was performed in a Danish cardiology unit. Patients aged ⩾ 18 years capable of SAM were eligible for inclusion. Patients were excluded if they did not self-administer medication at home, were not prescribed medication suitable for self-administration, or did not speak Danish. Intervention group participants self-administered their medication. In the control group, medication was dispensed and administered by nurses. Participants were allocated between groups by chance selection. The primary result of interest was the proportion of dispensing errors collected through observation of participants and nurses. Secondary results of interest were explored through telephone calls to determine participant perceptions regarding medication, participant satisfaction, and deviations in their medication list two weeks after discharge. Results: Significantly fewer dispensing errors were observed in the intervention group compared with the control group. At follow up, those who were self-administering medication had fewer concerns regarding their medication, found medication to be less harmful, were more satisfied, preferred this opportunity in the future, and had fewer deviations in their medication list after discharge compared with the control group. Conclusion: The reduced number of dispensing errors in the intervention group indicates that SAM is safe. In addition, SAM had a positive impact on (a) perceptions regarding medication, thus suggesting increased medication adherence, (b) deviations in medication list after discharge, and (c) participant satisfaction.

Objectives: The objective of this study was to evaluate the costs and consequences of introducing \"self-administration of medication\" (SAM) during hospitalization as compared with nurse-led dispensing and administration of medication. Methods: This pragmatic randomized controlled trial was performed in a Danish Cardiology Unit. Patients ⩾18 years old capable of self-administering medication were eligible. In the intervention group, patients self-administered their medication. In the control group, medication was dispensed and administered by nurses. The implementation of SAM was used to evaluate the cost–consequences. The micro-costing analysis used the hospital perspective and a short-term incremental costing approach. The costs for medication, materials, and nursing time were included. Consequences included the dispensing error proportion, patients’ perceptions regarding medication, satisfaction, and deviations in the medication list at follow-up. In addition, the number of readmissions and general practitioner (GP) contacts within 30 days after discharge was included. Results: The total cost (TC) per patient in the intervention group was 49.9€ (95% CI: 46.6–53.2) compared with 52.6€ (95% CI: 46.6–58.6) in the control group. The difference between the groups was not statistically significant (p = 0.09). Sensitivity analysis consistently showed TCs favoring the intervention. The dispensing error proportion was 9.7% (95% CI: 7.9–11.6) in the intervention group compared with 12.8% (95% CI: 10.9–15.6) in the control group. The difference was statistically significant (p = 0.02). The analysis also found changes in the perceptions regarding medication (indicating higher medication adherence), increased satisfaction, and fewer patients with deviations in the medication list at follow-up. No statistically significant differences between the groups in relation to readmissions and GP contacts within 30 days were observed. Conclusions: SAM seems to cost less although the cost difference was small and not statistically significant. As SAM had positive effects on patient outcomes, the results indicate that SAM may be cost-effective. Plain language summary Self-administration of medication: a research study of the costs and consequences Objectives To evaluate the costs and consequences of introducing “self-administration of medication” (SAM) during hospitalization compared to medication dispensed by nurses. Methods This research study included patients ≥18 years capable of self-administering medication and was performed in a Danish cardiology unit. Patients self-administered their own medication during hospitalization in the intervention group, whereas nurses dispensed and administered the medication in the control group. Patients were allocated between groups by randomization. The costs of SAM were analyzed from a hospital perspective and included costs for medication, materials, and nursing time. The consequences included the proportion of dispensing errors, patients’ perceptions regarding medication, patient satisfaction, deviations in the medication list at follow-up, the number of readmissions and general practitioner (GP) contacts within 30 days after discharge. Results The total cost per patient was 49.9€ in the intervention group compared to 52.6€ in the control group (p = 0.09). The cost difference between groups was not significant. The proportion of dispensing errors was significantly lower in the intervention group compared to the control group. In addition the research study found changes in the perceptions regarding medication, increased satisfaction, and fewer patients with deviations in the medication list at follow-up. For readmissions and GP contacts within 30 days no significant differences between groups were found. Conclusion SAM cost less or equal to medication dispensing and administration by nurse. SAM had positive impacts on patient outcomes. Therefore, SAM may be cost-effective.

Background Patient-reported outcome measures are increasingly used by clinicians to support communication in telephone- or face-to-face consultations with patients. A renal disease questionnaire has been developed, but not sufficiently evaluated through clinimetrics in clinical setting. Hence, we aimed to evaluate the content validity, construct validity and the test–retest reliability of a renal disease questionnaire to be used for clinical decision-making. Methods A content, construct validity and test–retest reliability study was conducted in 3 nephrology outpatient clinics in Central Denmark Region, Denmark. Content validity (face validity, comprehensibility and relevance) was assessed among 8 patients and 6 clinicians. Reliability was assessed by asking outpatients with chronic kidney disease to complete the questionnaire twice. Reliability was assessed by kappa statistics and agreement by percentage. Construct validity was determined using 4 a priori defined hypotheses and comparing 2 known groups. Results Five new domains emerged, 6 items were rephrased and 3 items were removed following the content validity test. A total of 160 patients completed the questionnaire with median 8 days (IQR 2 days) between assessments. The test–retest reliability parameters of the single items in the questionnaire were substantial to almost perfect as all the observed weighted kappa values ranged from 0.61 to 0.91, 95% CI (0.34 to 0.95). In total, 61% of the single items showed almost perfect agreement. In total, 3 of the 4 hypotheses were accepted and 44% of the items showed satisfying known-group discriminative validity. Conclusion A renal disease questionnaire used for clinical decision-making in outpatient follow-up showed acceptable content validity and substantial to almost perfect reliability. Sufficient construct validity was not established. Incorporating the questionnaire into routine clinical practice may improve the evaluation of disease burden in patients with chronic kidney disease. Plain English summary We ask patients with chronic kidney disease (CKD) in Central Region Denmark to complete a questionnaire before each outpatient visit. The answers they provide are used to support communication with their health care provider. A questionnaire requires testing to ensure it can accurately capture important information about patient’s symptoms and quality of life. When questionnaires are used to support communication between patients and health care professionals, they need to have good measurement properties. This means they need to be: (1) trustworthy, (2) relevant to a patient’s health condition, (3) consistent and produce stable results every time. We explored the measurement properties of a questionnaire designed to be used in the face-to face outpatient visits for patients with CKD. We found that the questionnaire captured consistent and stable results. Using this questionnaire may help health care professionals to assess the patients´ burden of symptoms with a more patient-centered approach. Potentially, the use of the questionnaire will increase the patients´ ability to cope with their symptoms and strengthen patients´ involvement in the clinical decisions concerning their treatment.

Background The integration of telehealth interventions into clinical practice is frequently delayed, hindering the full adoption. Previously, we developed a digital patient education (PE) programme for self-management in rheumatoid arthritis (RA). While the programme design considered crucial factors to ensure the likelihood of success in clinical practice, there is a need for a systematic evaluation of implementation perspectives. The purpose of this study was to explore perspectives crucial to implementation of a digital PE programme in clinical practice. Methods The non-adoption, abandonment, scale-up, spread and sustainability (NASSS) framework was used to evaluate the successes and challenges of implementing the digital PE programme. We included a data set consisting of qualitative focus group discussions involving study nurses, rheumatologists, and leaders from rheumatology departments. Data analysis was guided by a deductive content analysis approach. Further we included data from earlier studies pertaining to the programme’s implementation, comprising the programme development process, a randomized controlled trial evaluating the programme’s effectiveness, and a qualitative study exploring patients’ perspectives of the programme. Results Facilitators and challenges of importance to implementation of digital PE were identified. While a wide range of patients could benefit from using digital PE, future implementation should aim for an even broader group than those studied. Both patients and healthcare providers embraced the technology, and the fact that it did not require specific technical skills enhances its potential for success. However, offering digital PE should be based on individual assessments, and expanding its use will require organizational adjustments. An adaptable structure is needed to accommodate unforeseen care needs that may arise following the use of digital PE at home. There was indication of some reluctance among healthcare providers toward the programme shown by concerns about changing roles, which could impact the adoption of the program. Conclusions The design and ease of use of the technology, the program’s effectiveness, its availability, and the potential to release healthcare resources may encourage the implementation of digital patient education. Challenges associated with implementing this mode of care pertains to the condition and the patient population, user adoption of the technology, and the organization of patient education. Trial registration The study is registered by the Central Denmark Region Scientific Committee (no. 1-16-02-52-19).