This readme.txt file was generated on 2024-08-15 by the DRUM data curator. Recommended citation for the data: Bellin, Melena. (2024). Advancing Treatment for Pancreatitis: A Prospective Observational Study of TPIAT (POST Study). Protocol, Manual of Procedures, and Case Report Forms. Retrieved from the Data Repository for the University of Minnesota (DRUM), https://doi.org/10.13020/9M2P-ZE11. ------------------- GENERAL INFORMATION ------------------- 1. Title of Dataset: Advancing Treatment for Pancreatitis: A Prospective Observational Study of TPIAT (POST Study). Protocol, Manual of Procedures, and Case Report Forms 2. Author Information Author Contact: Staff Members POST (post@umn.edu) Name: Melena D. Bellin Institution: University of Minnesota-Twin Cities Medical School, Department of Pediatrics, Division of Pediatric Endocrinology Department of Surgery Email: bell0130@umn.edu ORCID: 0000-0002-7324-4837 3. Date published or finalized for release: 2024-08-08 4. Date of data collection: 2016-12-07 to 2023-07-18 5. Geographic location of data collection (where was data collected?): Baylor University Medical Center, Dallas, TX Cincinnati Children's Hospital Medical Center, Cincinnati, OH Dartmouth-Hitchcock Medical Center, Lebanon, NH Johns Hopkins Medical Institutions, Baltimore, MD The Medical University of South Carolina, Charleston, SC The Ohio State Wexner University Medical Center, Columbus, OH University of California San Francisco, San Francisco, CA University of Chicago, Chicago, IL University of Cincinnati, Cincinnati, OH University of Louisville, Louisville, KY University of Minnesota Medical School, Minneapolis, MN University of Pittsburgh Medical Center, Pittsburgh, PA 6. Information about funding sources that supported the collection of the data: National Institutes of Diabetes and Digestive and Kidney Diseases (R01-DK109124, PI M. Bellin), National Cancer Institute (U01-DK108327, PI D. Conwell) 7. Overview of the data (abstract): Total pancreatectomy with islet autotransplantation (TPIAT) is considered for managing chronic pancreatitis in selected patients when medical and endoscopic interventions have not provided adequate relief from debilitating pain. Although more centers are performing TPIAT, we lack large, multi-center studies to guide decisions about selecting candidates for and timing of TPIAT. Multiple centers across the United States performing TPIAT are prospectively enrolling patients undergoing TPIAT for chronic pancreatitis into the Prospective Observational Study of TPIAT (POST), a NIDDK funded study with a goal of accruing 450 TPIAT recipients. Baseline data include participant phenotype, pancreatitis history, and medical/psychological comorbidities from medical records, participant interview, and participant self-report (Medical Outcomes Survey Short Form-12, EQ-5D, andPROMIS inventories for pain interference, depression, and anxiety). Outcome measures are collected to at least 1 year after TPIAT, including the same participant questionnaires, visual analog pain scale, pain interference scores, opioid requirements, insulin requirements, islet graft function, and hemoglobin A1c. Health resource utilization data are collected for a cost-effectiveness analysis. Biorepository specimens including urine, serum/plasma, genetic material (saliva and blood), and pancreas tissue are collected for future study. This "dataset" in DRUM contains supplemental materials only: the final version of the POST Study's protocol, Manual of Procedures (MOP), and Case Report Forms (CRFs), for reference generally and specifically for the public-use datasets, which will be made available after the primary publications appear. The start date is the date when recruitment started, while the end date is the data of the form 500 confirming a 12-month visit in the POST Study. -------------------------- SHARING/ACCESS INFORMATION -------------------------- 1. Licenses/restrictions placed on the data: CC0 1.0 Universal (http://creativecommons.org/publicdomain/zero/1.0/) 2. Links to publications that cite or use the data: Bellin MD, Abu-El-Haija M, Morgan K, Adams D, Beilman GJ, Chinnakotla S, Conwell DL, Dunn TB, Freeman ML, Gardner T, Kirchner VA, Lara LF, Long-Simpson L, Nathan JD, Naziruddin B, Nyman JA, Pruett TL, Schwarzenberg SJ, Singh VK, Smith K, Steel JL, Wijkstrom M, Witkowski P, Hodges JS; POST study consortium. A multicenter study of total pancreatectomy with islet autotransplantation (TPIAT): POST (Prospective Observational Study of TPIAT). Pancreatology. 2018 Apr;18(3):286-290. doi: 10.1016/j.pan.2018.02.001. PMID: 29456124. PMCID: PMC5879010 3. Was data derived from another source? No If yes, list source(s): 4. Terms of Use: Data Repository for the U of Minnesota (DRUM) By using these files, users agree to the Terms of Use. https://conservancy.umn.edu/pages/policies/#drum-terms-of-use --------------------- DATA & FILE OVERVIEW --------------------- Filename: PROTOCOL_POST_v1_3_date19April2018 clean.pdf Short description: This is the POST Study's final protocol. Note that this is NOT a confidential document despite the language in the document's footer. Filename: POST MOP V2.0 080124.pdf Short description: This is the POST Study's final Manual of Procedures (MOP). Filename: POST All Forms 080124.pdf Short description: This is the POST Study's final set of Case Report Forms (CRFs). 2. Relationship between files: The included files are the latest versions of the protocol and MOP and of each CRF. The MOP is contained in a .pdf file and describes all study procedures, including details about completing each CRF. The CRFs are contained in a .pdf file; each CRF has a form number and item numbers for each data item collected. When the public-use datasets are published, their data dictionaries will refer to these form numbers and data items. -------------------------- METHODOLOGICAL INFORMATION -------------------------- 1. Description of methods used for collection/generation of data: Data were collected from participants' charts, participant interviews, and participant self-report. They were recorded on paper forms and transmitted to the Data & Coordinating Center (University of Minnesota Division of Biostatistics & Health Data Science) using a purpose-built remote data-entry system. 2. Methods for processing the data: The submitted data are maintained in the study database as submitted (with error corrections as appropriate and possible) and processed using standard statistical software to produce analyses in presentations and manuscripts. 3. Instrument- or software-specific information needed to interpret the data: This deposit includes no data. The eventual public-use dataset will be available as a .csv text file or as an .xlsx file. 4. Standards and calibration information, if appropriate: 5. Environmental/experimental conditions: This was a prospective cohort study using live human participants as described under item 1 above. 6. Describe any quality-assurance procedures performed on the data: During input into the remote data-entry system, range and other simple checks were performed (e.g., age had to be in the range specified in the eligibility criteria). A given form could not be deemed "entered" until all the data items had been entered, the form had been double-entered, and any discrepancies had been corrected. Once the data were entered successfully into the system, more thorough checks were done comparing items in the form to each other and to items entered on other forms for consistency, e.g., that form dates were in the correct order. Other errors have been corrected as detected, e.g., errors detected when preparing reports or doing analyses for presentations or manuscripts. 7. People involved with sample collection, processing, analysis and/or submission: At each center, data were collected primarily by the center's study coordinator(s) and were entered into the remote data-entry system by the coordinator or her/his designee. At the Data & Coordinating Center, the primary data custodian was the Database Administrator, and the error-correction process was largely implemented by the Study Manager 8. Location of original data: All paper forms are retained in binders at the study enrollment centers (clinics). All data entered through the study's remote data-entry system are retained in an electronic database at the Data & Coordinating Center (University of Minnesota Division of Biostatistics & Health Data Science). Please contact POST study staff at post@umn.edu to request access to the actual data.