ABSTRACT
OBJECTIVES: To describe use and treatment persistence for Janus kinase inhibitors (JAKi) in rheumatoid arthritis (RA) by line of therapy, and the mechanism of action for the drug switched to after JAKi discontinuation. METHODS: This was a retrospective, observational analysis using the OPAL dataset, a large collection of deidentified electronic medical records from 112 rheumatologists around Australia. Adult patients with RA were included if they initiated tofacitinib (TOF), baricitinib (BARI) or upadacitinib (UPA) between 1 October 2015 and 30 September 2021. Data were summarised using descriptive statistics. Kaplan-Meier survival was used to analyse treatment persistence. RESULTS: 5,900 patients initiated JAKi within the study window (TOF n=3,662, BARI n=1,875, UPA n=1,814). Median persistence was similar across JAKi within each line of therapy where there was sufficient follow-up, and almost 3 years for first-line: 34.9 months (95% CI 30.8, 40.7; n=1,408) for TOF, 33.6 months (95% CI 25.7, not reached; n=545) for BARI. While JAKi to JAKi switching occurred across all lines of therapy, switches to a tumour necrosis factor inhibitor (TNFi) were more frequent after first- or second-line JAKi. JAKi monotherapy use at baseline increased with line of therapy, and was highest at follow-up after switching to another JAKi. 'Lack of efficacy' was the most common reason for discontinuing JAKi. CONCLUSIONS: In this large analysis of Australian real-world practice separated by line of therapy, treatment persistence for JAKi was high overall subject to differential follow-up, but declined in later lines. JAKi to JAKi switching was observed across all lines of therapy.
ABSTRACT
AIM: To determine the direct health service costs and resource utilization associated with diagnosing and characterizing idiopathic inflammatory myopathies (IIMs), and to assess for limitations and diagnostic delay in current practice. METHODS: A retrospective, single-center cohort analysis of all patients diagnosed with IIMs between January 2012 and December 2021 in a large tertiary public hospital was conducted. Demographics, resource utilization and costs associated with diagnosing IIM and characterizing disease manifestations were identified using the hospital's electronic medical record and Health Intelligence Unit, and the Medicare Benefits Schedule. RESULTS: Thirty-eight IIM patients were identified. IIM subtypes included dermatomyositis (34.2%), inclusion body myositis (18.4%), immune-mediated necrotizing myopathy (18.4%), polymyositis (15.8%), and anti-synthetase syndrome (13.2%). The median time from symptom onset to diagnosis was 212 days (IQR: 118-722), while the median time from hospital presentation to diagnosis was 30 days (8-120). Seventy-six percent of patients required emergent hospitalization during their diagnosis, with a median length of stay of 8 days (4-15). The average total cost of diagnosing IIM was $15 618 AUD (STD: 11331) per patient. Fifty percent of patients underwent both MRI and EMG to identify affected muscles, 10% underwent both pan-CT and PET-CT for malignancy detection, and 5% underwent both open surgical and percutaneous muscle biopsies. Autoimmune serology was unnecessarily repeated in 37% of patients. CONCLUSION: The diagnosis of IIMs requires substantial and costly resource use; however, our study has identified potential limitations in current practice and highlighted the need for streamlined diagnostic algorithms to improve patient outcomes and reduce healthcare-related economic burden.
Subject(s)
Hospital Costs , Hospitals, Public , Myositis , Tertiary Care Centers , Humans , Retrospective Studies , Myositis/diagnosis , Myositis/economics , Myositis/therapy , Male , Female , Middle Aged , Tertiary Care Centers/economics , Hospitals, Public/economics , Aged , Adult , Health Resources/statistics & numerical data , Health Resources/economics , Health Care Costs , Delayed Diagnosis/economics , Predictive Value of Tests , Time Factors , AustraliaABSTRACT
BACKGROUND AND AIMS: This study aimed to assess the comparative effectiveness of the etanercept (ETN) originator (Enbrel) and ETN biosimilar SB4 (Brenzys) as first-line treatment in patients with rheumatoid arthritis (RA), while also exploring the potential cost-savings associated with this approach in Australia. METHODS: Clinical data were obtained from the Optimising Patient outcomes in rheumatoLogy Australian real-world data set. Adult patients with RA who had initiated treatment with the ETN originator or biosimilar as their first-recorded biologic or targeted synthetic disease-modifying antirheumatic drug between 1 April 2017 and 31 December 2020 were included. Treatment persistence was analysed using survival analysis. Cost-savings were estimated based on data reported by the Australian National Prescribing Service MedicineWise. RESULTS: Propensity score matching followed by inverse probability of treatment weighting selected patients taking originator (n = 209) or biosimilar (n = 141) with similar baseline characteristics and eliminated small differences in baseline disease activity. The median time for 50% of the patients to stop treatment was 19.4 months (95% confidence interval [CI], 14.7-36.4 months) for the originator and 22.4 months (95% CI, 15.0-33.1 months) for the biosimilar (P = 0.95). As a result of pricing policies established by the Australian Government, introduction of the ETN biosimilar would have resulted in a cost-savings of over AU$9.5 million for 1 year of treatment for the patients reported in this study. CONCLUSION: Treatment persistence using either ETN originator or biosimilar was similar. The cost of all brands of ETN markedly reduced upon listing of the ETN biosimilar, resulting in significant savings for the Australian Government.
ABSTRACT
OBJECTIVE: To describe the demographics, disease burden and real-world management of patients with systemic lupus erythematosus (SLE) in Australian community practice. METHODS: Patients with a physician diagnosis of SLE and at least 1 visit between 1 January 2009 and 31 March 2021 were identified in the OPAL dataset, an aggregated collection of data extracted from the electronic medical records of patients managed by 112 Australian rheumatologists. Demographics, basic clinical features and prescribed medications were described, with medication combinations used as a surrogate of disease severity. RESULTS: Of 5133 patients with a diagnosis of lupus, 4260 (83%) had SLE. Of these SLE patients, almost 90% of patients were female, with a median age of 49 years [IQR 37-61] at first-recorded visit. Of the 2285 SLE patients whose most recent visit was between 1 January 2019 and 31 March 2021, 52.5% had mild disease, 29.9% had moderate-severe disease and 7.4% had very severe disease. Visit frequency increased with disease severity. Most patients (85.8%) were treated with hydroxychloroquine, typically prescribed as first line-of-therapy. CONCLUSION: In this large real-world Australian cohort of patients with SLE, a substantial burden of disease was identified, with a significant proportion (almost one-third of patients) considered to have moderate to severe disease based on medication use. This study provides a greater understanding of the path from symptom onset to treatment and the heterogeneous presentation of patients with SLE who are treated in community practice in Australia. Key messages ⢠Most published studies describing patients with SLE are derived from specialist lupus centres, typically in the hospital setting, therefore little is known about the characteristics of patients with SLE who are receiving routine care in community clinics. ⢠The OPAL dataset is a large collection of clinical data from the electronic medical records of rheumatologists predominantly practising in private community clinics, which is where the majority (73-80%) of adult rheumatology services are conducted in Australia [1-3] . Since data from community care has not been widely available for SLE research, this study contributes important insight into this large and under-reported patient population. ⢠To improve access to care and effective treatments, and reduce the burden of SLE in Australia, a greater understanding of the characteristics and unmet needs of patients with SLE managed in the community setting is required.
Subject(s)
Lupus Erythematosus, Systemic , Adult , Humans , Female , Middle Aged , Male , Australia/epidemiology , Lupus Erythematosus, Systemic/drug therapy , Lupus Erythematosus, Systemic/epidemiology , Lupus Erythematosus, Systemic/diagnosis , Hydroxychloroquine/therapeutic use , Treatment Outcome , Cost of IllnessABSTRACT
Importance: There is a need for observational studies to supplement evidence from clinical trials, and the target trial emulation (TTE) framework can help avoid biases that can be introduced when treatments are compared crudely using observational data by applying design principles for randomized clinical trials. Adalimumab (ADA) and tofacitinib (TOF) were shown to be equivalent in patients with rheumatoid arthritis (RA) in a randomized clinical trial, but to our knowledge, these drugs have not been compared head-to-head using routinely collected clinical data and the TTE framework. Objective: To emulate a randomized clinical trial comparing ADA vs TOF in patients with RA who were new users of a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD). Design, Setting, and Participants: This comparative effectiveness study emulating a randomized clinical trial of ADA vs TOF included Australian adults aged 18 years or older with RA in the Optimising Patient Outcomes in Australian Rheumatology (OPAL) data set. Patients were included if they initiated ADA or TOF between October 1, 2015, and April 1, 2021; were new b/tsDMARD users; and had at least 1 component of the disease activity score in 28 joints using C-reactive protein (DAS28-CRP) recorded at baseline or during follow-up. Intervention: Treatment with either ADA (40 mg every 14 days) or TOF (10 mg daily). Main Outcomes and Measures: The main outcome was the estimated average treatment effect, defined as the difference in mean DAS28-CRP among patients receiving TOF compared with those receiving ADA at 3 and 9 months after initiating treatment. Missing DAS28-CRP data were multiply imputed. Stable balancing weights were used to account for nonrandomized treatment assignment. Results: A total of 842 patients were identified, including 569 treated with ADA (387 [68.0%] female; median age, 56 years [IQR, 47-66 years]) and 273 treated with TOF (201 [73.6%] female; median age, 59 years [IQR, 51-68 years]). After applying stable balancing weights, mean DAS28-CRP in the ADA group was 5.3 (95% CI, 5.2-5.4) at baseline, 2.6 (95% CI, 2.5-2.7) at 3 months, and 2.3 (95% CI, 2.2-2.4) at 9 months; in the TOF group, it was 5.3 (95% CI, 5.2-5.4) at baseline, 2.4 (95% CI, 2.2-2.5) at 3 months, and 2.3 (95% CI, 2.1-2.4) at 9 months. The estimated average treatment effect was -0.2 (95% CI, -0.4 to -0.03; P = .02) at 3 months and -0.03 (95% CI, -0.2 to 0.1; P = .60) at 9 months. Conclusions and Relevance: In this study, there was a modest but statistically significant reduction in DAS28-CRP at 3 months for patients receiving TOF compared with those receiving ADA and no difference between treatment groups at 9 months. Three months of treatment with either drug led to clinically relevant average reductions in mean DAS28-CRP, consistent with remission.
Subject(s)
Arthritis, Rheumatoid , Adult , Humans , Female , Middle Aged , Male , Adalimumab/therapeutic use , Australia , Arthritis, Rheumatoid/drug therapy , Piperidines/therapeutic use , C-Reactive ProteinABSTRACT
OBJECTIVE: To analyze comparative treatment persistence for first-line baricitinib (BARI) versus first-line tumor necrosis factor inhibitor (TNFi) in patients with rheumatoid arthritis (RA) and for first-line BARI initiated as monotherapy versus first-line BARI initiated with at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD). METHODS: Patients with RA who initiated BARI or TNFi as first-line biologic or targeted synthetic DMARD from October 1, 2015, to September 30, 2021, were identified in the OPAL data set. Drug survival times to 6, 12, and 24 months were analyzed using restricted mean survival time (RMST). Multiple imputation and inverse probability of treatment weighting were used to address missing data and nonrandom treatment assignment. RESULTS: A total of 545 patients initiated first-line BARI, including 118 as monotherapy and 427 as csDMARD combination therapy. Three thousand five hundred patients initiated first-line TNFi. There was no difference in drug survival to 6 or 12 months for BARI compared with TNFi; differences in RMST were 0.02 months (95% CI: -0.08 to 0.013; P = 0.65) and 0.31 months (95% CI: -0.02 to 0.63; P = 0.06), respectively. Patients in the BARI group had 1.00 month (95% CI: 0.14 to 1.86; P = 0.02) longer drug survival to 24 months. There was no difference in drug survival for BARI monotherapy compared with combination therapy, with differences in RMST to 6, 12, and 24 months of -0.19 months (95% CI: -0.50 to 0.12; P = 0.12), -0.35 months (95% CI: -1.17 to 0.42; P = 0.41), and -0.56 months (95% CI: -2.66 to 1.54; P = 0.60), respectively. CONCLUSION: In this comparative analysis, treatment persistence up to 24 months was significantly longer for first-line BARI compared with TNFi, but the effect size of 1.00 month is not clinically meaningful. There was no difference in persistence for BARI monotherapy versus combination therapy.
ABSTRACT
Objective: To develop a simple and secure technological solution to incorporate electronic patient-reported outcomes (ePROs) into routine clinical care. Methods: A novel ePRO questionnaire delivery system was developed by Software for Specialists (S4S) in partnership with OPAL Rheumatology Australia. Validated questionnaires were sent from the electronic medical record (EMR) (Audit4) of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), lupus or giant cell arteritis (GCA) and delivered to the patient's email address or completed in the clinic waiting room using a smart device (in-practice). Completed questionnaires were encrypted and returned to the patient's Audit4. Deidentified clinical data was extracted and aggregated across all sites. Data collected between April 2016-Dec 2020 were analysed descriptively. Results: Between April 2016 to Dec 2020, 221,352 Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F), Patient Health Questionnaire-2 (PHQ-2) and/or HealthCare Resource Utilization (HCRU) questionnaires were sent from 39 of 42 contributing clinics (93%). 85% of questionnaires were delivered via email and 15% in-practice. Overall, 85% of patients completed at least one questionnaire, and of all questionnaires sent, 73% were completed. Females were more likely to engage with the questionnaires than males (87% vs. 81%), and older patients were slightly more likely to complete all questionnaires delivered. Conclusions: The novel Audit4 ePRO delivery system is an effective tool for incorporating PROs into routine clinical care. The data generated provides a unique opportunity to understand the full burden of disease for patients in the real-world setting and the impact of interventions.
ABSTRACT
OBJECTIVE: To describe the treatment response and persistence to biologic disease-modifying antirheumatic drug (bDMARD) therapy in patients with ankylosing spondylitis (AS) in a real-world Australian cohort. METHODS: This was a retrospective, noninterventional cohort study that extracted data for patients with AS from the Optimising Patient outcomes in Australian RheumatoLogy (OPAL) dataset for the period of August 2006 to September 2019. Patients were classified as either bDMARD initiators if they commenced a bDMARD during the sampling window, or bDMARD-naïve if they did not. Results were summarized descriptively. Treatment persistence was calculated using Kaplan-Meier methods. Differences in treatment persistence were explored using log-rank tests. RESULTS: There were 5048 patients with AS identified. Of these, 2597 patients initiated bDMARDs and 2451 remained bDMARD-naïve throughout the study window. Treatment with first-, second-, and third-line bDMARDs significantly reduced disease activity. Median persistence on first-line bDMARDs was 96 months (95% CI 85-109), declining to 19 months (95% CI 16-22) in second-line therapy, and 15 months (95% CI 11-18) in third-line therapy. Median persistence was longest for the golimumab (GOL) group in all lines of therapy and shortest for the etanercept (ETN) group. Differences in persistence rates according to the time period that bDMARDs were prescribed (pre- and post-2012) were also seen for ETN and adalimumab. CONCLUSION: In this cohort, all bDMARDs effectively reduced AS disease activity. Treatment persistence was sustained for up to 8 years for patients remaining on their first bDMARD, longer than on subsequent agents. Further research is needed to determine its influence on treatment recommendations.
Subject(s)
Antirheumatic Agents , Arthritis, Rheumatoid , Spondylitis, Ankylosing , Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/drug therapy , Australia , Biological Therapy , Cohort Studies , Etanercept/therapeutic use , Humans , Retrospective Studies , Spondylitis, Ankylosing/drug therapy , Treatment OutcomeABSTRACT
INTRODUCTION AND OBJECTIVES: Pneumocystis jirovecii pneumonia (PJP) is an opportunistic fungal infection that affects the immunocompromised. Patients with systemic autoimmune rheumatic disease are increasingly recognised as an at-risk clinical population with a high mortality. This case-control study examined differences in the characteristics and peripheral blood parameters between patients with systemic autoimmune rheumatic disease who developed PJP and gender, age and disease-matched controls. METHODS: Historical data collected between 2002 and 2013 at the Royal Melbourne Hospital, Australia were reviewed. Cases were defined by having a systemic autoimmune rheumatic disease and a diagnosis of PJP (either a positive toluidine blue O stain or P. jirovecii PCR, with a concurrent respiratory illness that was clinically consistent with PJP). Controls were matched for age, gender and disease in a 4:1 ratio. Peripheral blood results were retrieved from an in-house pathology database. Clinical information including glucocorticoid exposure, PJP prophylaxis, comorbidities and month of admission were retrieved from medical notes. RESULTS: After adjustment for corticosteroid exposure and C-reactive protein, lymphocyte count on admission (0.4 vs. 1.3; p = 0.04) and at nadir (0.2 vs. 0.8 × 109/L; p = 0.05) was significantly lower in cases than in controls. Cases (n = 11) were more frequently Caucasian rather than non-Caucasian (81.8% vs. 65.9%; p = 0.04). In addition, cases more commonly presented in autumn (March to May) than in other seasons (OR = 7.3; 95% CI: 1.4-38.7; p = 0.02). CONCLUSION: These data demonstrate that patients with systemic autoimmune rheumatic disease who develop PJP have significantly greater lymphopenia than age, gender and disease-matched controls, independent of corticosteroid exposure, as well as a potential ethnicity and seasonal predilection to PJP. This may help to inform prophylactic guidelines for PJP in these patients.
Subject(s)
Autoimmune Diseases/complications , Opportunistic Infections/complications , Pneumocystis carinii/isolation & purification , Pneumonia, Pneumocystis/complications , Rheumatic Diseases/complications , Aged , Autoimmune Diseases/immunology , Case-Control Studies , Female , Humans , Immunocompromised Host , Male , Middle Aged , Opportunistic Infections/immunology , Pneumonia, Pneumocystis/immunology , Retrospective Studies , Rheumatic Diseases/immunologySubject(s)
Anti-Bacterial Agents/therapeutic use , Ciprofloxacin/therapeutic use , Hand/diagnostic imaging , Legionella longbeachae/isolation & purification , Legionellosis/complications , Tenosynovitis/microbiology , Aged , Female , Humans , Legionellosis/diagnostic imaging , Legionellosis/drug therapy , Tenosynovitis/diagnostic imaging , Tenosynovitis/drug therapy , Treatment OutcomeABSTRACT
INTRODUCTION: Pneumocystis jirovecci pneumonia (PJP) is an opportunistic fungal infection occurring in immunocompromised patients, such as those with human immunodeficiency virus (HIV), organ transplantation, malignancies and connective tissue diseases (CTDs). Risk factors for PJP are not well characterised, leading to uncertainty regarding the indications for antimicrobial prophylaxis and monitoring. This study compared differences between patients with and without CTDs who developed PJP. METHODS: Retrospective data was collected for all subjects with a positive toludine blue O stain or a positive P. jirovecci PCR and a concurrent respiratory illness that was clinically consistent with PJP between 2002 and 2013 at the Royal Melbourne Hospital, Australia. Sub-groups were assigned according to the underlying disease. Peripheral blood results were retrieved from an in-house pathology database. RESULTS: Eleven of 90 subjects (12.2%) diagnosed with PJP had underlying CTDs. The CTDs group was more likely to have been exposed to corticosteroids (100% versus 35.2%, p < 0.001) and other iatrogenic immunosuppression (90.9% versus 24.6%, p < 0.001). After adjusting for age and gender, the CTDs group had greater lymphopaenia (0.17 versus 0.58 × 10(9)/L; p = 0.034) and were older (69.6 versus 50.6 years; p < 0.001) than the non-CTD group. Excluding renal transplant recipients, people with CTDs also had lower eGFR than the non-CTD group (65 versus 80; p = 0.015). CONCLUSIONS: CTDs contributed to a significant proportion of total PJP diagnoses. Clinicians treating CTDs must be vigilant for PJP, particularly in older patients with exposure to corticosteroids or other iatrogenic immunosuppression, lymphopaenia and renal impairment; factors which may lower the clinical threshold for initiating prophylaxis.
Subject(s)
Connective Tissue Diseases/complications , Immunocompromised Host , Opportunistic Infections/complications , Pneumonia, Pneumocystis/complications , Adult , Aged , Connective Tissue Diseases/immunology , Female , Humans , Male , Middle Aged , Opportunistic Infections/immunology , Pneumocystis carinii , Pneumonia, Pneumocystis/immunology , Retrospective Studies , Risk FactorsABSTRACT
OBJECTIVES: To develop and test an evidence-based, multimedia patient education program (MPEP) about methotrexate (MTX) treatment for rheumatoid arthritis (RA) and a new measure of patient knowledge [Methotrexate in Rheumatoid Arthritis Knowledge test (MiRAK)]. METHODS: The content of the MPEP and MiRAK was guided by concept-mapping workshops with patients (N = 24), literature review, health professional, and expert linguistic input. The MPEP and MiRAK underwent multiple stages of testing and revision with patients and health professionals. The MiRAK was administered to RA patients (N = 169) and its properties examined using the Rasch analyses. A subset of respondents (N = 131) repeated the MiRAK to determine test-retest reliability. A before-after pilot study with patients who had recently started MTX (N = 31) tested responsiveness of the MiRAK and feasibility and acceptability of the MPEP. RESULTS: A DVD of 24-minutes duration was produced that presents detailed, evidence-based information about MTX. The Rasch analyses of the 60 MiRAK items revealed that these could be summated into a single score. The MiRAK had good model fit, supporting internal construct validity, good internal consistency (person separation index; 0.84), test-retest reliability (ICC; 0.89), and ability to detect change (ES; 2.38). The before-after study suggested that patients could self-administer the MPEP, with the majority finding it informative and easy to use. CONCLUSIONS: We developed a MPEP about MTX treatment for RA, which was found to be user-friendly and easily implementable. The MiRAK is a new scale, testing a broad spectrum of MTX knowledge. Analyses revealed strong evidence for its validity and reliability.
Subject(s)
Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/drug therapy , Methotrexate/therapeutic use , Patient Education as Topic , Adult , Aged , Female , Humans , Male , Middle Aged , Multimedia , Program Development , Quality of Life , Surveys and QuestionnairesABSTRACT
BACKGROUND: Although Methotrexate (MTX) is one of the most commonly prescribed disease-modifying drugs in JIA no questionnaire exists that assesses the knowledge of parents about this drug. A 60-item questionnaire was recently developed to measure rheumatoid arthritis (RA) patients' knowledge about MTX; the Methotrexate in Rheumatoid Arthritis Knowledge Test (MiRAK; Ciciriello et al. (Arthritis Rheum 62:10-1009, 2010)). This study aimed to adapt the MiRAK for parents of children with JIA. METHODS: Adaption of the MiRAK involved: 1) email consultations with clinicians working in the field of paediatric rheumatology (Panel 1) to ascertain the potential adaptations of the MiRAK from a clinical perspective, 2) synthesis of clinicians' suggestions by a panel of experts, researchers and MiRAK developers (Panel 2) to reach consensus on which items needed to be modified and create a draft Methotrexate in Juvenile Idiopathic Arthritis Knowledge Test (MiJIAK), 3) a review of the draft by 5 parents of children with JIA (Panel 3) using the cognitive 'think-aloud' method, 4) a second consultation with Panel 2 to review parents' suggestions and determine the final items. RESULTS: A total of 9 items remained unchanged, e.g. "Methotrexate is effective at relieving joint stiffness", 19 were deemed inappropriate in the paediatric setting and deleted, e.g. "It is safe to become pregnant 3 weeks after methotrexate has been stopped", 32 underwent editorial changes largely to indicate that the questionnaire was about the children with JIA, e.g. "If you forget to give a dose of Methotrexate, you can still take it the next day" became "If your child misses a dose of Methotrexate, they can still take it the next day", and 1 new item was added. A new 42-item questionnaire was produced and was found to be well understood by parents of children with JIA. CONCLUSIONS: The systematic modification of the MiRAK, a patient-centred MTX knowledge questionnaire, has generated a comprehensive new questionnaire for use in the JIA setting. The wide consultation process, including cognitive testing, has ensured the tool is both relevant and acceptable to clinicians and will therefore be a valuable addition in understanding the parents' perspective of this treatment in JIA.
ABSTRACT
BACKGROUND: Health consumers increasingly want access to accurate, evidence-based information about their medications. Currently, education about medications (that is, information that is designed to achieve health or illness related learning) is provided predominantly via spoken communication between the health provider and consumer, sometimes supplemented with written materials. There is evidence, however, that current educational methods are not meeting consumer needs. Multimedia educational programs offer many potential advantages over traditional forms of education delivery. OBJECTIVES: To assess the effects of multimedia patient education interventions about prescribed and over-the-counter medications in people of all ages, including children and carers. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2011, Issue 6), MEDLINE (1950 to June 2011), EMBASE (1974 to June 2011), CINAHL (1982 to June 2011), PsycINFO (1967 to June 2011), ERIC (1966 to June 2011), ProQuest Dissertation & Theses Database (to June 2011) and reference lists of articles. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs of multimedia-based patient education about prescribed or over-the-counter medications in people of all ages, including children and carers, if the intervention had been targeted for their use. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias of included studies. Where possible, we contacted study authors to obtain missing information. MAIN RESULTS: We identified 24 studies that enrolled a total of 8112 participants. However, there was significant heterogeneity in the comparators used and the outcomes measured, which limited the ability to pool data. Many of the studies did not report sufficient information in their methods to allow judgment of their risk of bias. From the information that was reported, three of the studies had a high risk of selection bias and one was at high risk of bias due to lack of blinding of the outcome assessors. None of the included studies reported the minimum clinically important difference for the outcomes that were measured. We have therefore reported results from the studies but have been unable to interpret whether differences were of clinical importance.The main findings of the review are as follows.Knowledge: There is low quality evidence that multimedia education was more effective than usual care (non-standardised education provided as part of usual clinical care) or no education (standardised mean difference (SMD) 1.04, 95% confidence interval (CI) 0.49 to 1.58, six studies with 817 participants). There was considerable statistical heterogeneity (I(2) = 89%), however, all but one of the studies favoured the multimedia group. There is moderate quality evidence that multimedia education was not more effective at improving knowledge than control multimedia interventions (i.e. multimedia programs that do not provide information about the medication) (mean difference (MD) of knowledge scores 2.78%, 95% CI -1.48 to 7.0, two studies with 568 participants). There is moderate quality evidence that multimedia education was more effective when added to a co-intervention (written information or brief standardised instructions provided by a health professional) compared with the co-intervention alone (MD of knowledge scores 24.59%, 95% CI 22.34 to 26.83, two studies with 381 participants).Skill acquisition: There is moderate quality evidence that multimedia education was more effective than usual care or no education (MD of inhaler technique score 18.32%, 95% CI 11.92 to 24.73, two studies with 94 participants) and written education (risk ratio (RR) of improved inhaler technique 2.14, 95% CI 1.33 to 3.44, two studies with 164 participants). There is very low quality evidence that multimedia education was equally effective as education by a health professional (MD of inhaler technique score -1.01%, 95% CI -15.75 to 13.72, three studies with 130 participants).Compliance with medications: There is moderate quality evidence that there was no difference between multimedia education and usual care or no education (RR of complying 1.02, 95% CI 0.96 to 1.08, two studies with 4552 participants).We could not determine the effect of multimedia education on other outcomes, including patient satisfaction, self-efficacy and health outcomes, due to an inadequate number of studies from which to draw conclusions. AUTHORS' CONCLUSIONS: This review provides evidence that multimedia education about medications is more effective than usual care (non-standardised education provided by health professionals as part of usual clinical care) or no education, in improving both knowledge and skill acquisition. It also suggests that multimedia education is at least equivalent to other forms of education, including written education and education provided by a health professional. However, this finding is based on often low quality evidence from a small number of trials. Multimedia education about medications could therefore be considered as an adjunct to usual care but there is inadequate evidence to recommend it as a replacement for written education or education by a health professional. Multimedia education may be considered as an alternative to education provided by a health professional, particularly in settings where provision of detailed education by a health professional is not feasible. More studies evaluating multimedia educational interventions are required in order to increase confidence in the estimate of effect of the intervention.Conclusions regarding the effect of multimedia education were limited by the lack of information provided by study authors about the educational interventions, and variability in their content and quality. Studies testing educational interventions should provide detailed information about the interventions and comparators. Research is required to establish a framework that is specific for the evaluation of the quality of multimedia educational programs. Conclusions were also limited by the heterogeneity in the outcomes reported and the instruments used to measure them. Research is required to identify a core set of outcomes which should be measured when evaluating patient educational interventions. Future research should use consistent, reliable and validated outcome measures so that comparisons can be made between studies.
Subject(s)
Health Knowledge, Attitudes, Practice , Multimedia , Nonprescription Drugs/therapeutic use , Patient Education as Topic/methods , Prescription Drugs/therapeutic use , Humans , Medication Adherence , Patient Education as Topic/standards , Randomized Controlled Trials as TopicABSTRACT
The workshop Choosing or Developing Instruments held at the Outcome Measures in Rheumatology (OMERACT) 10 meeting was designed to help participants think about the underlying methods of instrument development. Conference pre-reading material and 3 brief introductory presentations elaborated the issues, and participants broke into discussion groups before reconvening to share insights, engage in a more general discussion of the issues, and vote on recommendations. Tradeoffs between using current imperfect measures and the long and complex process of developing new instruments were considered, together with the need for rigor in patient-reported outcome (PRO) instrument development. The main considerations for PRO instrument development were listed and a research agenda for action produced. As part of the agenda for action, it is recommended that researchers and patient partners work together to tackle these issues, and that OMERACT bring forward proposals for acceptable instrument development protocols that would meet an enhanced "Truth" statement in the OMERACT Filter.
Subject(s)
Outcome Assessment, Health Care/methods , Outcome Assessment, Health Care/standards , Patient Satisfaction , Rheumatology/methods , Treatment Outcome , Arthritis, Rheumatoid/therapy , Humans , Rheumatology/standards , Surveys and QuestionnairesABSTRACT
This report summarizes the proceedings of the first Outcome Measures in Rheumatology Clinical Trials (OMERACT) Health Literacy Special Interest Group workshop at the OMERACT 10 conference. Health literacy refers to an individual's capacity to seek, understand, and use health information. Discussion centered on the relevance of health literacy to the rheumatology field; whether measures of health literacy were important in the context of clinical trials and routine care; and, if so, whether disease-specific measures were required. A nominal group process involving 27 workshop participants, comprising a patient group (n = 12) and a healthcare professional and researcher group (n = 15), confirmed that health literacy encompasses a broad range of concepts and skills that existing scales do not measure. It identified the importance and relevance of patient abilities and characteristics, but also health professional factors and broader contextual factors. Sixteen themes were identified: access to information; cognitive capacity; disease; expression/communication; finances; health professionals; health system; information; literacy/numeracy; management skills; medication; patient approach; dealing with problems; psychological characteristics; social supports; and time. Each of these was divided further into subthemes of one or more of the following: knowledge, attitude, attribute, relationship, skill, action, or context. There were virtually no musculoskeletal-specific statements, suggesting that a generic health literacy tool in rheumatology is justified. The detailed concepts across themes provided new and systematic insight into what needs to be done to improve health literacy and consequently reduce health inequalities. These data will be used to derive a more comprehensive measure of health literacy.