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Dr. James Hodges is a biostatistician in the School of Public Health. His primary research interest is oral-health research, infectious diseases, neurology, and kidney disease. Type of Data

Dr. Hodges submitted the following dataset to be curated for reuse in the library. These data are histographic periodontal data, or large-scale studies that measure participant’s teeth over time. The primary author of the data is Bryan Michalowicz from the UMN School of Dentistry, who was PI of the grant that Hodges collaborated on. A public-use version of the dataset was created in November 2009, but has never been released in a repository. The file format for the raw data is in .csv and .txt format since the large 5MB file is not operable in MS Excel. The personal-level (proceeded) dataset is in MS Excel and 1.7MBs. Both are deidentified for public use and total ~ 12.8MB in size.

Metadata

Hodges, on submission, choose to fill out the following metadata fields.

Title: Public-Use Data from the Obstetrics and Periodontal Therapy (OPT) Study, a

randomized trial of periodontal therapy to prevent pre-term birth

Creator(s): James S. Hodges -- author of record in Digital Conservancy Agreement

Bryan S. Michalowicz -- Principal Investigator of the OPT Study Date: 2009-11-02

Coverage,

Temporal: 2003-2006

Abstract: The OPT Study was a multi-center randomized, single-blind (examiners) controlled clinical trial testing whether mechanical periodontal therapy (scaling and planning) in pregnant women at risk for premature birth reduced the extent or severity of premature birth. OPT found that periodontal therapy does not reduce the number or timing of premature births. Nonetheless, this public-use dataset is of interest in that it provides natural and clinical

histories of the periodontal status of pregnant women with treated and untreated periodontal disease.

Data include birth outcomes (including gestational age, birth weight, presence of congenital anomalies, and 1 and 5 minute APGAR scores), baseline

Final  report  to  the  University  Libraries  in  fulfillment  of  the  2013  President's  Excellence  in  Leadership  program    

characteristics (including previous pregnancy outcomes), periodontal therapy and essential dental care delivered as part of the study, maternal conditions during pregnancy, and the following items for three visits between the end of the first trimester and delivery: clinical periodontal measurements (pocket depth, attachment loss, and bleeding on probing at 6 sites per tooth; site-specific data and several common person-level summaries), medications, dental plaque levels of 8 bacterial species, levels of serum antibodies for the same 8 bacterial species, and serum levels of 8 inflammatory markers or mediators. The OPT Study's Manual of Procedures (Version 1) is available as part of this package. Version changes during the course of the study were rare and affected very few data items (mostly the data describing study periodontal therapy). The public-use dataset includes the version of these data items used in the main and secondary papers.

The OPT Study team published the main paper in 2006 in the New England Journal of Medicine and has published 8 secondary papers. The dataset was made available in 2009 but has not previously been available online because the sponsoring agency had no facility for making it available.

Grants: The data in these files were collected during the OPT Study funded by the

National Institute of Dental and Craniofacial Research, grant number DE014338. Keywords: Periodontal therapy, Pre-term birth, Randomized controlled trial, Periodontal

measurements, Pregnant women Related

Articles: (main paper) Michalowicz BS, Hodges JS, DiAngelis AJ, Lupo VR, Novak MJ,

Ferguson JE, Buchanan W, Bofill J, Papapanou PN, Mitchell DA, Matseoane S, Tschida PA; OPT Study. Treatment of periodontal disease and the risk of preterm birth. N Engl J Med. 2006 Nov 2;355(18):1885-94.

(Note: 8 secondary papers not listed here for presentation purposes)

Additional Information

On submission, Hodges shared some information about the dataset with you via phone: ● These data are a public-use dataset but the funding institute, the National Institute of

Dental & Craniofacial Research, has no facility for hosting such datasets even though their standard contract requires that such a public-use dataset be preserved.

● To host the data, Dr. Hodges explains that “it sits on my computer and if anybody asks for it, I send them the dataset and the modest documentation. This has been 2 people so far. It'd be more available if it were in a repository of similar datasets.”

● Hodges feels that he owns the data and has signed a deposit agreement for the library. ● Documentation was added due to participating in this study. Those files include a Data

Final  report  to  the  University  Libraries  in  fulfillment  of  the  2013  President's  Excellence  in  Leadership  program    

Submission Information Package (SIP):

Here are all the files received from Dr. Hodges, including the metadata information that is written above, called author_generated_metadata.rtf.

Final  report  to  the  University  Libraries  in  fulfillment  of  the  2013  President's  Excellence  in  Leadership  program    

Final  report  to  the  University  Libraries  in  fulfillment  of  the  2013  President's  Excellence  in  Leadership  program    

Screenshot of OPT_Study_Documentation_Data_Dictionary.doc

Final  report  to  the  University  Libraries  in  fulfillment  of  the  2013  President's  Excellence  in  Leadership  program     C.3 Interdisciplinary Data