Neratinib as Extended Adjuvant Treatment of HER2-Positive/HR-Positive Early Breast Cancer Patients in Germany, Austria, and Switzerland: Interim Results of the Prospective, Observational ELEANOR Study.

Prognosis of patients diagnosed with HER2+ early breast cancer (eBC) has substantially improved, but distant recurrences impacting quality of life and survival still occur. One treatment option for extended adjuvant treatment of patients with HER2+/HR+ eBC is neratinib, available in Europe for patients who completed adjuvant trastuzumab-based therapy within 1 year. The ELEANOR study is investigating the real-world use of neratinib in Germany, Austria, and Switzerland. Results from an interim analysis of the first 200 patients observed for ≥3 months are reported. The primary objective of this prospective, multicenter, observational study is to assess patient adherence to neratinib (defined as the percentage of patients taking neratinib on ≥75% prescribed days). Secondary objectives are patient characteristics and treatment outcomes. At cut-off (May 2, 2022), a total of 202 patients had been observed for ≥3 months, with neratinib treatment documented for 187 patients (median age: 53.0 years; 67.9% at increased risk of disease recurrence). In total, 151 (80.7%) patients had received prior neoadjuvant treatment; of these, 82 (54.3%) patients achieved a pathologically complete response. Neratinib was initiated at a median 3.6 months after trastuzumab-based treatment, with 36.4% starting at a dose <240 mg/day. Treatment is ongoing for 46.0% of patients, with median treatment duration of 11.2 (interquartile range 0.9-12.0) months. Diarrhea was the most common adverse event (78.6% any grade, 20.3% grade ≥3); pharmacologic prophylaxis was used in 85.6% of patients. The pattern of anti-HER2 pretreatment observed reflected the current treatment for HER2+/HR+ eBC in Germany, Austria, and Switzerland. These interim results suggest that neratinib as an extended adjuvant is a feasible option after various anti-HER2 pretreatments and that its tolerability can be managed and improved with proactive diarrhea management

Adherence to COREQ Reporting Guidelines for Qualitative Research: A Scientometric Study in Nursing Social Science

Qualitative research plays an important role in helping us describe, interpret and generate theories about complex phenomena in healthcare. Complete and transparent reporting of research informs readers about the significance and rigor of the work. The aim of this scientometric study was to determine the quality of reporting of qualitative research in nursing social science. Studies were identified by manually searching the table of contents for qualitative papers published in the June (or closest subsequent) 2018 issue of 115 nursing journals. Adherence with the 32-item Consolidated Criteria for REporting Qualitative (COREQ) research was determined for each study by two researchers. Additional information about the study (e.g., sample size, field of nursing) and the publishing journal (e.g., endorsement of COREQ) were also extracted. Using established criteria, COREQ compliance was coded either good (≥ 25 items), moderate (17 to 24), poor (9 to 16), very poor (≤ 8) based on the number of items addressed in each study. One hundred and ninety-seven manuscripts were included. The quality of reporting was generally rated as either moderate (57%) or poor (38%). Journal endorsement of qualitative reporting guidelines was associated with better reporting. The reporting of qualitative research in nursing social science journals is suboptimal. Researchers, authors, reviewers and journal editors need to ensure their papers comprehensively address the requirements of COREQ to ensure comprehensive and transparent reporting of their research