Generalizable EHR-R-REDCap pipeline for a national multi-institutional rare tumor patient registry.

OBJECTIVE: To develop a clinical informatics pipeline designed to capture large-scale structured Electronic Health Record (EHR) data for a national patient registry. MATERIALS AND METHODS: The EHR-R-REDCap pipeline is implemented using R statistical software to remap and import structured EHR data into the Research Electronic Data Capture (REDCap)-based multi-institutional Merkel Cell Carcinoma (MCC) Patient Registry using an adaptable data dictionary. RESULTS: Clinical laboratory data were extracted from EPIC Clarity across several participating institutions. Laboratory values (Labs) were transformed, remapped, and imported into the MCC registry using the EHR labs abstraction (eLAB) pipeline. Forty-nine clinical tests encompassing 482 450 results were imported into the registry for 1109 enrolled MCC patients. Data-quality assessment revealed highly accurate, valid labs. Univariate modeling was performed for labs at baseline on overall survival (N = 176) using this clinical informatics pipeline. CONCLUSION: We demonstrate feasibility of the facile eLAB workflow. EHR data are successfully transformed and bulk-loaded/imported into a REDCap-based national registry to execute real-world data analysis and interoperability.

The Merkel Cell Carcinoma Patient Registry: From Promise to Prototype to Patient.

The Merkel Cell Carcinoma (MCC) Patient Registry is a national multi-institutional collaborative effort that will prospectively follow and record outcomes and events in MCC patients. MCC is the prototypical rare tumor, and this Registry will trail blaze new methodologies that will enable multiple investigators to examine real world outcome data in real time. Deliverables from the Registry include precise patient stratification into risk categories, identification of best practices, real-world data for drug development programs, revelations about optimal sequence and combinations therapies, uncovering low incidence toxicities, and the generation of novel testable hypotheses. Importantly, the Registry offers a way forward in the yet-unsolved dilemma of drug development for rare tumors, since the Registry's design will allow the creation of highly defined patient-level data that can be used as a robust comparator for single arm phase I and II clinical trials. The MCC Task Force comprises members from academic medical centers, the drug industry, the National Institutes of Health, and the US Food and Drug Administration. Project Data Sphere, LLC provides a secure, open-access data sharing platform and comprehensive support to optimize research performance and ensure rigorous and timely results. The Registry is currently in development and is based on a REDCap database integrated into the host institution's electronic medical record. We plan to have the first patient accessioned on Project Data Sphere's data platform in the second quarter of 2022. Members of the MCC Registry Task Force represent a joint effort of research and clinical investigators from academia, industry and regulatory science to develop the first publicly held MCC registry on Project Data Sphere's open-access data platform. Our hope is that this shared repository will allow investigators to identify new approaches, improve treatment outcomes, shorten the time from discovery to implementation and, ultimately, improve patient lives.

REDCap-Based Operational Tool to Guide Care Coordination in a Multidisciplinary Cutaneous Oncology Clinic.

The multidisciplinary team is the primary means for delivery of complex cancer care in the United States. Considerable variability exists in how multidisciplinary teams operate across the landscape of oncology, including variation in represented specialties and specifics of the shared medical decision-making process. Here, we describe operations of a multidisciplinary clinic focused on the management of nonmelanoma skin cancer, formed as a joint effort between departments at the Massachusetts General Hospital and Massachusetts Eye and Ear Infirmary. We describe deployment of a flexible Web-based operational tool created on the Research Electronic Data Capture platform to facilitate provider coordination and tracking and visualization of the patient census, offering a new perspective on optimization of the multidisciplinary workflow. To help promote further discussion, we have made the data dictionary for the operational tool and R code for the accompanying data visualization dashboard freely available online for download and customization.

Evaluation of clinical characteristics and pre-biopsy impressions of primary Merkel cell carcinoma of the skin.

Merkel cell carcinoma is an aggressive carcinoma of the skin notable for protean presentation on physical exam. A retrospective cohort of 232 patients with primary cutaneous Merkel cell carcinoma was reviewed for availability of data on pre-biopsy clinical differential diagnosis based on clinical exam. Data was available for 192 patients (83%). The three most common impressions were cyst (33.3%), basal cell carcinoma (31.8%), and squamous cell carcinoma (19.8%). Merkel cell carcinoma was correctly suspected in only 13 cases (6.8%). A greater proportion of lesions that were less than or equal to 2 cm in diameter (10.2%) or carried BCC as a co-diagnosis (11.5%) were correctly suspected as Merkel cell carcinoma prior to biopsy, versus lesions greater than 2 cm in diameter (1.6%) or carrying SCC as a co-diagnosis (2.6%), suggesting that clinicians may be anchoring on the well-publicized concept of Merkel cell carcinoma as a small, pearly papule in real-world practice.

Metastatic Merkel Cell Carcinoma Masquerading as Multiple Immune-Related Adverse Events.

Merkel cell carcinoma is a rare cutaneous neuroendocrine carcinoma with a high rate of regional and distant metastasis and mortality. Here, we report a novel case of Merkel cell carcinoma which presented as a primary lesion to the left cheek with regional lymph node involvement and was treated with pembrolizumab and radiation. Widely metastatic disease eventually revealed on autopsy clinically mimicked immune-related organ insult leading to management with immunosuppressants. The patient also had a biopsy-confirmed immune-related cutaneous adverse event during admission. The case highlights a rare circumstance in which disease progression masqueraded as multiple immune-related end-organ adverse events. Contribution of on-target anti-PD-1 toxicity remains a possibility.

A novel strategy for utilizing voice coil servoactuators in tensile tests of low volume protein hydrogels.

We present a novel tensile testing system optimized for the mechanical loading of microliter volume protein hydrogels. Our apparatus incorporates a voice coil servoactuator capable of carrying out fixed velocity extension-relaxation cycles as well as extension step protocols. The setup is equipped with an acrylic cuvette permitting day-long incubations in solution. To demonstrate the functionality of the device, we photochemically crosslinked polyproteins of the I91 immunoglobulin domain from the muscle protein titin to create solid hydrogels that recapitulate elastic properties of muscle. We present data from tensile tests of these low volume biomaterials that support protein unfolding as a main determinant of the elasticity of protein hydrogels. Our results demonstrate the potential use of protein hydrogels as biomaterials whose elastic properties dynamically respond to their environment.