The characteristics and reporting quality of research impact case studies: A systematic review.

Despite the growing expectation that researchers report the impact of their research using a case study approach, systematic reviews of research impact have focused on frameworks, indicators, methods of data collection and assessment rather than impact case studies. Our aim is to provide an overview of the characteristics of published research impact case studies, including translation activities, and their reporting quality. We searched for peer-reviewed impact studies published between 2000 and 2018 using a case study approach and selected 25 suitable papers. We applied descriptive statistics to study characteristics, conducted thematic analysis of research translation activities and assessed reporting quality using the 10-point ISRIA statement. 24 papers reported intermediate impacts, such as advocacy, or the development of statements, tools, or technology. 4 reported on longer-term societal impacts, such as health outcomes and economic return on investment. 7 reported on translation activities. Papers scored well against the ISRIA statement on 5 domains of reporting quality. Weakest scores centred around identification of stakeholder needs and stakeholder involvement, and ethics and conflict of interest. We identified the need for more consistency in reporting through a case study approach, more systematic reporting of translation pathways and greater transparency concerning estimated costs and benefits of the research and its translation and impact assessment.

Modified AJCC staging of gastric neuroendocrine carcinoma based on T staging can improve the capacity of prognosis assessment.

BACKGROUND OR PURPOSE: This study was designed to determine the value of AJCC staging 7th edition and improved AJCC staging in assessing the prognosis of gastric neuroendocrine carcinoma (GNEC). METHODS: In total, GNEC 475 patients in the Surveillance, Epidemiology, and End Results (SEER) database and 129 GNEC patients in our department undergoing resection were included. The former served as the test group, and the latter served as the validation group. Those with stage IIIb disease were allocated into four subgroups, and improved AJCC staging was established. The AIC and C indices were used to evaluate the capacities of different TNM staging. RESULTS: Significant overlap between stages IIIb and IIIa in both the test and validation groups was found. In the test group, T staging and age at disease diagnosis were independent prognostic factors for patients with stage IIIb. Stage IIIb was divided into T1N1, T2N1, T3N1 and T4N1, and the improved AJCC staging-mTNM staging was created. In mTNM staging, the IIIb survival curve did not cross those of stages IIIa and IIb, which had a smaller AIC (2490 vs. 2507) value and larger C index (0.7624 vs. 0.7450, P = 0.228). Similar results were obtained for the validation group. CONCLUSION: T stage was an independent factor influencing the prognosis of stage IIIb GNEC patients, and the improved AJCC staging proposed here has good prognostic value.

A decision tree-based prediction model for fluorescence in situ hybridization HER2 gene status in HER2 immunohistochemistry-2+ breast cancers: a 2538-case multicenter study on consecutive surgical specimens.

Objective: To investigate the proportion of HER2 gene amplifications and the association between the HER2-IHC-staining pattern and gene status in IHC-2+ breast cancers according to 2013 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. Methods: We retrospectively analyzed and re-evaluated the IHC-staining pattern of 2538 IHC-2+ surgical specimens of breast cancer from November 2014 to October 2015 in 12 institutions. All cases used for building a prediction model of HER2 gene amplification according to the IHC-staining pattern and were randomly divided into a training set (n = 1914) or validation set (n = 624). Results: The overall HER2 fluorescence in situ hybridization (FISH) amplification, non-amplification and equivocation rates in HER2 IHC-2+ cases were 17.8%, 76.2% and 6.0%, respectively. In the training set, cases that had ≤ 10% of cells with intense, complete and circumferential membrane staining or had > 85% of cells with complete membrane staining of any staining intensity tended to be HER2 gene amplified (77.0% and 60.5%, respectively). And cases with weak and incomplete membrane staining had the lowest amplification rate of 6.1%. The prediction model was constructed based on IHC-staining pattern in the training set and validated using a validation set. The positive and negative prediction values were 51.6% and 79.2%, respectively, in the validation set. Moreover, the HER2 copy number per cell was much higher in cases with amplification-associated staining patterns (7.84 and 8.75) than in cases with non-amplification-associated staining patterns (2.97 to 4.41, P < 0.05). Conclusions: In HER2 IHC-2+ breast cancers, the staining pattern is associated with the HER2 gene status. This finding is compatible with recommendations of 2013 ASCO/CAP guidelines.