Rituximab as therapy to induce remission after relapse in ANCA-associated vasculitis

Funder: Research Committee on Intractable Vasculitides; The Ministry of Health, Labour and Welfare of Japan.Objectives: Evaluation of rituximab and glucocorticoids as therapy to induce remission after relapse in ANCA-associated vasculitis (AAV) in a prospective observational cohort of patients enrolled into the induction phase of the RITAZAREM trial. Methods: Patients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis were prospectively enrolled and received remission-induction therapy with rituximab (4×375 mg/m2) and a higher or lower dose glucocorticoid regimen, depending on physician choice: reducing from either 1 mg/kg/day or 0.5 mg/kg/day to 10 mg/day by 4 months. Patients in this cohort achieving remission were subsequently randomised to receive one of two regimens to prevent relapse. Results: 188 patients were studied: 95/188 (51%) men, median age 59 years (range 19–89), prior disease duration 5.0 years (range 0.4–34.5). 149/188 (79%) had previously received cyclophosphamide and 67/188 (36%) rituximab. 119/188 (63%) of relapses had at least one major disease activity item, and 54/188 (29%) received the higher dose glucocorticoid regimen. 171/188 (90%) patients achieved remission by 4 months. Only six patients (3.2% of the study population) did not achieve disease control at month 4. Four patients died in the induction phase due to pneumonia (2), cerebrovascular accident (1), and active vasculitis (1). 41 severe adverse events occurred in 27 patients, including 13 severe infections. Conclusions: This large prospective cohort of patients with relapsing AAV treated with rituximab in conjunction with glucocorticoids demonstrated a high level of efficacy for the reinduction of remission in patients with AAV who have relapsed, with a similar safety profile to previous studies

Rituximab as therapy to induce remission after relapse in ANCA-associated vasculitis

Funder: Research Committee on Intractable Vasculitides; The Ministry of Health, Labour and Welfare of Japan.Objectives: Evaluation of rituximab and glucocorticoids as therapy to induce remission after relapse in ANCA-associated vasculitis (AAV) in a prospective observational cohort of patients enrolled into the induction phase of the RITAZAREM trial. Methods: Patients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis were prospectively enrolled and received remission-induction therapy with rituximab (4×375 mg/m2) and a higher or lower dose glucocorticoid regimen, depending on physician choice: reducing from either 1 mg/kg/day or 0.5 mg/kg/day to 10 mg/day by 4 months. Patients in this cohort achieving remission were subsequently randomised to receive one of two regimens to prevent relapse. Results: 188 patients were studied: 95/188 (51%) men, median age 59 years (range 19–89), prior disease duration 5.0 years (range 0.4–34.5). 149/188 (79%) had previously received cyclophosphamide and 67/188 (36%) rituximab. 119/188 (63%) of relapses had at least one major disease activity item, and 54/188 (29%) received the higher dose glucocorticoid regimen. 171/188 (90%) patients achieved remission by 4 months. Only six patients (3.2% of the study population) did not achieve disease control at month 4. Four patients died in the induction phase due to pneumonia (2), cerebrovascular accident (1), and active vasculitis (1). 41 severe adverse events occurred in 27 patients, including 13 severe infections. Conclusions: This large prospective cohort of patients with relapsing AAV treated with rituximab in conjunction with glucocorticoids demonstrated a high level of efficacy for the reinduction of remission in patients with AAV who have relapsed, with a similar safety profile to previous studies

Assessing changes in the quality of quantitative health educations research: a perspective from communities of practice

Abstract Background As a community of practice (CoP), medical education depends on its research literature to communicate new knowledge, examine alternative perspectives, and share methodological innovations. As a key route of communication, the medical education CoP must be concerned about the rigor and validity of its research literature, but prior studies have suggested the need to improve medical education research quality. Of concern in the present study is the question of how responsive the medical education research literature is to changes in the CoP. We examine the nature and extent of changes in the quality of medical education research over a decade, using a widely cited study of research quality in the medical education research literature as a benchmark to compare more recent quality indicators. Methods A bibliometric analysis was conducted to examine the methodologic quality of quantitative medical education research studies published in 13 selected journals from September 2013 to December 2014. Quality scores were calculated for 482 medical education studies using a 10-item Medical Education Research Study Quality Instrument (MERSQI) that has demonstrated strong validity evidence. These data were compared with data from the original study for the same journals in the period September 2002 to December 2003. Eleven investigators representing 6 academic medical centers reviewed and scored the research studies that met inclusion and exclusion criteria. Primary outcome measures include MERSQI quality indicators for 6 domains: study design, sampling, type of data, validity, data analysis, and outcomes. Results There were statistically significant improvements in four sub-domain measures: study design, type of data, validity and outcomes. There were no changes in sampling quality or the appropriateness of data analysis methods. There was a small but significant increase in the use of patient outcomes in these studies. Conclusions Overall, we judge this as equivocal evidence for the responsiveness of the research literature to changes in the medical education CoP. This study identified areas of strength as well as opportunities for continued development of medical education research.http://deepblue.lib.umich.edu/bitstream/2027.42/173627/1/12909_2022_Article_3301.pd

Assessing changes in the quality of quantitative health educations research: a perspective from communities of practice.

BackgroundAs a community of practice (CoP), medical education depends on its research literature to communicate new knowledge, examine alternative perspectives, and share methodological innovations. As a key route of communication, the medical education CoP must be concerned about the rigor and validity of its research literature, but prior studies have suggested the need to improve medical education research quality. Of concern in the present study is the question of how responsive the medical education research literature is to changes in the CoP. We examine the nature and extent of changes in the quality of medical education research over a decade, using a widely cited study of research quality in the medical education research literature as a benchmark to compare more recent quality indicators.MethodsA bibliometric analysis was conducted to examine the methodologic quality of quantitative medical education research studies published in 13 selected journals from September 2013 to December 2014. Quality scores were calculated for 482 medical education studies using a 10-item Medical Education Research Study Quality Instrument (MERSQI) that has demonstrated strong validity evidence. These data were compared with data from the original study for the same journals in the period September 2002 to December 2003. Eleven investigators representing 6 academic medical centers reviewed and scored the research studies that met inclusion and exclusion criteria. Primary outcome measures include MERSQI quality indicators for 6 domains: study design, sampling, type of data, validity, data analysis, and outcomes.ResultsThere were statistically significant improvements in four sub-domain measures: study design, type of data, validity and outcomes. There were no changes in sampling quality or the appropriateness of data analysis methods. There was a small but significant increase in the use of patient outcomes in these studies.ConclusionsOverall, we judge this as equivocal evidence for the responsiveness of the research literature to changes in the medical education CoP. This study identified areas of strength as well as opportunities for continued development of medical education research