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Improving Data Collection for Patients Who Developed Graft-Versus-Host Disease after Hematopoietic Stem Cell Transplantation
Abstracts / Biol Blood Marrow Transplant 23 (2017) S18–S391
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Figure 2. A.) Immunostaining of pSMAD2/3, SMA, Col1 and TGFβ3 in the week 4 skin of the RDEB mice that received human serum albumin (left panels) and USSCs i.h. (right panels) at birth. B). Collagen lattice contraction assay of human fibroblasts from normal donor and two patients with RDEB, in response to 48 hour serum stimulation, with or without USSC transwell coculture.
the Fb cocultured with USSCs (P ≤ .05). Consistent with the in vitro study, significantly decreased expression of MMP9 and 13, as well as elevated expression of TGFβ3 and DCN were observed in the RDEB skin following i.h or i.h./i.d injection(s) of USSCs, as compared to the skin with vehicle control (Figure 1). We further demonstrated that TGFβ signaling was activated with age via phosphorylation of Smad2/3 in the skin of RDEB mice. Importantly, pSmad2/3 was not observed in the skin of the RDEB mice that received i.h. USSC injection, suggesting USSC administration inhibited TGFβ signaling (Figure 2). Supportively, the levels of smooth muscle actin (SMA) and collagen 1 (Col1) that correlate with fibrosis were significantly less in the skin of the RDEB mice with USSC treatment. Accumulation of TGFβ3 was also observed in the USSCtreated RDEB skin, but not in the untreated or vehicle injected RDEB skin (Figure 2). The antifibrotic effects of USSCs in the RDEB mouse model was further validated in the collagen lattice contraction assay, which demonstrated that USSCs coculture (in both direct mix and transwell culture (Figure 2B)) ameliorated contraction of RDEB patients- derived Fb. Conclusion: CB- derived USSCs suppress TGF-β signaling and fibrosis in the RDEB skin.
TRANSPLANTATION DATA MANAGEMENT (FOR CPR/DM CONFERENCE)
339 Improving Data Collection for Patients Who Developed Graft-Versus-Host Disease after Hematopoietic Stem Cell Transplantation Adriana Mendes Cavilha 1, Heliz Regina A. Neves 2, Vanessa Manetti 1, Carmem Bonfim 3, Vaneuza Araujo Moreira Funke 4, Samir Nabhan 5, Ricardo Pasquini 6. 1 Servico de Transplante de Medula Ossea, Hospital de Clinicas—UFPR, Curitiba, Brazil; 2 Servico de Transplante de Medula Ossea, Hospital de Clinicas—UFPR, Curitiba, OS, Brasil; 3 Pediatric Blood and Marrow Transplantation Service, Federal University of Paraná, Curitiba, Brazil; 4 Hematology, Federal University of Parana, Curitiba, Brazil; 5 Eurocord International Registry, Paris,
France; 6 Blood and Marrow Transplantation Service, Federal University of Parana, Curitiba, Brazil Introduction: Graft-versus-host disease (GVHD) is one of the major complications after hematopoietic stem cell transplantation (HSCT). It is estimated that chronic GVHD (cGVHD) affects 30-70% of allogeneic HSCT recipients. Diagnosing and staging of both, acute and chronic GVHD, is an extremely detailed and complex procedure, what makes the data collection difficult for data managers. Objective: Thus, in order to facilitate the data collection, we are proposing physical assessment and the completion of standardized GVHD form by nurses, based on the consensus of National Institutes of Health (NIH). Material: Since 1979 the Bone Marrow Transplantation Unit at the Federal University of Parana (BMT-UFPR) performed 2623 transplants (92% allogeneic) and since 1985 we report data to the CIBMTR (Research Center). In order to evaluate GVHD data collection, we decided to analyze 130 patients who are still alive and which developed cGVHD from 2005 to 2016. Methodology: In 2005 it was created a new data collection form for acute and chronic GVHD, and the database from BMTUFPR was reformulated. But, although there were consensus recommendations from NIH, these data collection forms were poorly filled, according to data managers. The greatest difficulties were found in patients who developed skin and/or gut GVHD, because the clinical assessment is subjective, sometimes incomplete and not standardized at the patient’s charts. Thus, it was decided to create a new form according to revised NIH Consensus classification and FormsNet from CIBMTR to be checked by a nurse, after medical assessment and completion. Also there will be a pre evaluation of the patients by the nurse in order to optimize patient information before physician assessment. Results: Physical evaluation and completion of GVHD forms have been checked by nurses since August this year and will be assessed continuously. 54 patients were evaluated and had forms completed from August to September 2016. Medium percentage of data filled by physician and checked by nurses through the new form has improved 73%. Conclusion: This initial approach has facilitated the data collection by data managers, because physical assessment and completion of the GVHD form by nurses, followed by medical
S252
Abstracts / Biol Blood Marrow Transplant 23 (2017) S18–S391
assessment ensured better quality of the information collected.
340 Electronic Patient Shadow Chart Conversion—a Single Center Experience Kate Dennert 1, Jaime Kroll 2, Nina Garlie 2. 1 Regenerative Medicine, Aurora St. Luke’s Medical Center, Milwaukee, WI; 2 Autologous Stem Cell Transplant Program, Aurora St. Luke’s Medical Center, Milwaukee, WI Background: Our center is continually looking to transition from paper to electronic processes because it is efficient and cost effective. In addition, during our CIBMTR audit in 2011 our error rates were higher than anticipated and we aimed to improve them with better organization during the next audit. To accomplish these goals a process was developed in 2011 to store patient charts for CIBMTR electronically. It has been in use for over five years with few changes. Methods: An electronic folder is created and labeled with the patient name. Inside that folder are subfolders discernible by timeframe, such as “Doe, John PreTx.” All source documentation for the timeframe is saved into these folders. Our hospital system uses EPIC which allows us to access patient data even when the patient visit is outside our facility, but within our network. Data retrieved from EPIC is saved as a PDF file, labeled by the date and type of data, for example a PET scan performed on 04/27/2014 for a given patient would be saved as “042714 PET.pdf” in the patient’s chart in the appropriate timeframe folder. Any data that is notobtained electronically is scanned and saved into the patient folder using the same naming rules as above. For instance, Karnofsky scores are acquired from the physician on paper because a signature is required, then scanned and saved into the patient file. Documents can be searched by date or by type of file (PET scan, labs, etc.). Previously, people would page through a stack of papers to find what they needed. Microsoft Word templates were created for each CIBMTR form we use (Transplant Essential Data and Comprehensive). The templates contain all data required from our center in one location, thus allowing us to easily submit data to CIBMTR through FormsNet3. Previously a blank PreTED 2400 form would be printed and filled out by hand, then used to enter data into FormsNet3. The completed template is saved in the electronic patient chart. This ensures that a working document is available if FormsNet3 malfunctions or submission cannot be done immediately. Conclusion/Summary: This process has proven to be very efficient. Data retrieval is much faster using a systemwide electronic health record vs calling another facility, waiting for faxes, and filing reports in a paper folder. The data is much more organized than our previous paper charts because all data is organized by date and file type. This also cuts the cost of materials used to make paper charts as well as requiring storage space. In comparison, our center spent no money making this conversion. We have improved our outcomes for CIBMTR data audits between 2011 and 2015. Our overall error rate in 2011 was 3.0% requiring corrective action and in 2015 it dropped to .9% with no corrective action required. Both CIBMTR and FACT accreditation final reports listed our documentation as excellent. Our next step is to scan previous paper charts into electronic folders as time permits.
341 Reducing Critical Field Data Error Rate with Audit Review Tanika D. Dillard, Sara Roman. Blood and Marrow Transplant Program, Greenville Health System Cancer Institute, Greenville, SC Background: To ensure the highest degree of accuracy of data reported to CIBMTR, The Blood and Marrow Transplant Program of Greenville Health System Cancer Institute adopted the audit tool utilized by CIBMTR. Objective: To share the process used for continuous quality improvement to reduce the critical data field error rate. Methods: The Data Coordinator (DC) completes and processes forms in Form Net. The change history form is exported to Excel into a replica of the CIBMTR audit tool (Figure 1) which contains the question number, description, answer entered by DC, and source documentation referenced to obtain data. Data fields from the change history form are populated into the audit tool and made available to data staff to audit. The auditor verifies accuracy of each field by comparing the pre-populated “current value” field to the source document referenced in the audit tool. If the data field is correct, auditor enters “Yes”/“Y” into the “Correct Value” field. If the data field is incorrect, auditor enters “No”/“N” into the “Correct Value” field and the correct answer in the “notes” column. The auditor then selects the Error Type from a drop down menu, if applicable. o Missing Documentation (MD)—Data submitted to the CIBMTR but the supporting documentation was missing at the time of audit. o Incorrect (I)—Data found in the medical record was discrepant from the data reported to the CIBMTR. o Omission (O)—Data found in the medical record but not reported on the form. Forms are routed back to DC for error correction and reprocessed in FormsNet. Conclusion: Implementing internal data audit review process has reduced the critical error rate from 2.9% in 2010 to an average of 1.5% from 2014–2016.
Figure 1.
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Figure 2. A.) Immunostaining of pSMAD2/3, SMA, Col1 and TGFβ3 in the week 4 skin of the RDEB mice that received human serum albumin (left panels) and USSCs i.h. (right panels) at birth. B). Collagen lattice contraction assay of human fibroblasts from normal donor and two patients with RDEB, in response to 48 hour serum stimulation, with or without USSC transwell coculture.
the Fb cocultured with USSCs (P ≤ .05). Consistent with the in vitro study, significantly decreased expression of MMP9 and 13, as well as elevated expression of TGFβ3 and DCN were observed in the RDEB skin following i.h or i.h./i.d injection(s) of USSCs, as compared to the skin with vehicle control (Figure 1). We further demonstrated that TGFβ signaling was activated with age via phosphorylation of Smad2/3 in the skin of RDEB mice. Importantly, pSmad2/3 was not observed in the skin of the RDEB mice that received i.h. USSC injection, suggesting USSC administration inhibited TGFβ signaling (Figure 2). Supportively, the levels of smooth muscle actin (SMA) and collagen 1 (Col1) that correlate with fibrosis were significantly less in the skin of the RDEB mice with USSC treatment. Accumulation of TGFβ3 was also observed in the USSCtreated RDEB skin, but not in the untreated or vehicle injected RDEB skin (Figure 2). The antifibrotic effects of USSCs in the RDEB mouse model was further validated in the collagen lattice contraction assay, which demonstrated that USSCs coculture (in both direct mix and transwell culture (Figure 2B)) ameliorated contraction of RDEB patients- derived Fb. Conclusion: CB- derived USSCs suppress TGF-β signaling and fibrosis in the RDEB skin.
TRANSPLANTATION DATA MANAGEMENT (FOR CPR/DM CONFERENCE)
339 Improving Data Collection for Patients Who Developed Graft-Versus-Host Disease after Hematopoietic Stem Cell Transplantation Adriana Mendes Cavilha 1, Heliz Regina A. Neves 2, Vanessa Manetti 1, Carmem Bonfim 3, Vaneuza Araujo Moreira Funke 4, Samir Nabhan 5, Ricardo Pasquini 6. 1 Servico de Transplante de Medula Ossea, Hospital de Clinicas—UFPR, Curitiba, Brazil; 2 Servico de Transplante de Medula Ossea, Hospital de Clinicas—UFPR, Curitiba, OS, Brasil; 3 Pediatric Blood and Marrow Transplantation Service, Federal University of Paraná, Curitiba, Brazil; 4 Hematology, Federal University of Parana, Curitiba, Brazil; 5 Eurocord International Registry, Paris,
France; 6 Blood and Marrow Transplantation Service, Federal University of Parana, Curitiba, Brazil Introduction: Graft-versus-host disease (GVHD) is one of the major complications after hematopoietic stem cell transplantation (HSCT). It is estimated that chronic GVHD (cGVHD) affects 30-70% of allogeneic HSCT recipients. Diagnosing and staging of both, acute and chronic GVHD, is an extremely detailed and complex procedure, what makes the data collection difficult for data managers. Objective: Thus, in order to facilitate the data collection, we are proposing physical assessment and the completion of standardized GVHD form by nurses, based on the consensus of National Institutes of Health (NIH). Material: Since 1979 the Bone Marrow Transplantation Unit at the Federal University of Parana (BMT-UFPR) performed 2623 transplants (92% allogeneic) and since 1985 we report data to the CIBMTR (Research Center). In order to evaluate GVHD data collection, we decided to analyze 130 patients who are still alive and which developed cGVHD from 2005 to 2016. Methodology: In 2005 it was created a new data collection form for acute and chronic GVHD, and the database from BMTUFPR was reformulated. But, although there were consensus recommendations from NIH, these data collection forms were poorly filled, according to data managers. The greatest difficulties were found in patients who developed skin and/or gut GVHD, because the clinical assessment is subjective, sometimes incomplete and not standardized at the patient’s charts. Thus, it was decided to create a new form according to revised NIH Consensus classification and FormsNet from CIBMTR to be checked by a nurse, after medical assessment and completion. Also there will be a pre evaluation of the patients by the nurse in order to optimize patient information before physician assessment. Results: Physical evaluation and completion of GVHD forms have been checked by nurses since August this year and will be assessed continuously. 54 patients were evaluated and had forms completed from August to September 2016. Medium percentage of data filled by physician and checked by nurses through the new form has improved 73%. Conclusion: This initial approach has facilitated the data collection by data managers, because physical assessment and completion of the GVHD form by nurses, followed by medical
S252
Abstracts / Biol Blood Marrow Transplant 23 (2017) S18–S391
assessment ensured better quality of the information collected.
340 Electronic Patient Shadow Chart Conversion—a Single Center Experience Kate Dennert 1, Jaime Kroll 2, Nina Garlie 2. 1 Regenerative Medicine, Aurora St. Luke’s Medical Center, Milwaukee, WI; 2 Autologous Stem Cell Transplant Program, Aurora St. Luke’s Medical Center, Milwaukee, WI Background: Our center is continually looking to transition from paper to electronic processes because it is efficient and cost effective. In addition, during our CIBMTR audit in 2011 our error rates were higher than anticipated and we aimed to improve them with better organization during the next audit. To accomplish these goals a process was developed in 2011 to store patient charts for CIBMTR electronically. It has been in use for over five years with few changes. Methods: An electronic folder is created and labeled with the patient name. Inside that folder are subfolders discernible by timeframe, such as “Doe, John PreTx.” All source documentation for the timeframe is saved into these folders. Our hospital system uses EPIC which allows us to access patient data even when the patient visit is outside our facility, but within our network. Data retrieved from EPIC is saved as a PDF file, labeled by the date and type of data, for example a PET scan performed on 04/27/2014 for a given patient would be saved as “042714 PET.pdf” in the patient’s chart in the appropriate timeframe folder. Any data that is notobtained electronically is scanned and saved into the patient folder using the same naming rules as above. For instance, Karnofsky scores are acquired from the physician on paper because a signature is required, then scanned and saved into the patient file. Documents can be searched by date or by type of file (PET scan, labs, etc.). Previously, people would page through a stack of papers to find what they needed. Microsoft Word templates were created for each CIBMTR form we use (Transplant Essential Data and Comprehensive). The templates contain all data required from our center in one location, thus allowing us to easily submit data to CIBMTR through FormsNet3. Previously a blank PreTED 2400 form would be printed and filled out by hand, then used to enter data into FormsNet3. The completed template is saved in the electronic patient chart. This ensures that a working document is available if FormsNet3 malfunctions or submission cannot be done immediately. Conclusion/Summary: This process has proven to be very efficient. Data retrieval is much faster using a systemwide electronic health record vs calling another facility, waiting for faxes, and filing reports in a paper folder. The data is much more organized than our previous paper charts because all data is organized by date and file type. This also cuts the cost of materials used to make paper charts as well as requiring storage space. In comparison, our center spent no money making this conversion. We have improved our outcomes for CIBMTR data audits between 2011 and 2015. Our overall error rate in 2011 was 3.0% requiring corrective action and in 2015 it dropped to .9% with no corrective action required. Both CIBMTR and FACT accreditation final reports listed our documentation as excellent. Our next step is to scan previous paper charts into electronic folders as time permits.
341 Reducing Critical Field Data Error Rate with Audit Review Tanika D. Dillard, Sara Roman. Blood and Marrow Transplant Program, Greenville Health System Cancer Institute, Greenville, SC Background: To ensure the highest degree of accuracy of data reported to CIBMTR, The Blood and Marrow Transplant Program of Greenville Health System Cancer Institute adopted the audit tool utilized by CIBMTR. Objective: To share the process used for continuous quality improvement to reduce the critical data field error rate. Methods: The Data Coordinator (DC) completes and processes forms in Form Net. The change history form is exported to Excel into a replica of the CIBMTR audit tool (Figure 1) which contains the question number, description, answer entered by DC, and source documentation referenced to obtain data. Data fields from the change history form are populated into the audit tool and made available to data staff to audit. The auditor verifies accuracy of each field by comparing the pre-populated “current value” field to the source document referenced in the audit tool. If the data field is correct, auditor enters “Yes”/“Y” into the “Correct Value” field. If the data field is incorrect, auditor enters “No”/“N” into the “Correct Value” field and the correct answer in the “notes” column. The auditor then selects the Error Type from a drop down menu, if applicable. o Missing Documentation (MD)—Data submitted to the CIBMTR but the supporting documentation was missing at the time of audit. o Incorrect (I)—Data found in the medical record was discrepant from the data reported to the CIBMTR. o Omission (O)—Data found in the medical record but not reported on the form. Forms are routed back to DC for error correction and reprocessed in FormsNet. Conclusion: Implementing internal data audit review process has reduced the critical error rate from 2.9% in 2010 to an average of 1.5% from 2014–2016.
Figure 1.