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The MAPP research network: design, patient characterization and operations.

Landis JR, Williams DA, Lucia MS, Clauw DJ, Naliboff BD, Robinson NA, van Bokhoven A, Sutcliffe S, Schaeffer AJ, Rodriguez LV, Mayer EA, Lai HH, Krieger JN, Kreder KJ, Afari N, Andriole GL, Bradley CS, Griffith JW, Klumpp DJ, Hong BA, Lutgendorf SK, Buchwald D, Yang CC, Mackey S, Pontari MA, Hanno P, Kusek JW, Mullins C, Clemens JQ, MAPP Research Network Study Gro - BMC Urol (2014)

Bottom Line: A highly novel effort to develop and assess clinically relevant animal models of UCPPS was also undertaken to allow improved translation between clinical and mechanistic studies.An extended follow-up study for 161 of the UCPPS participants is ongoing.The MAPP Research Network represents a novel, comprehensive approach to the study of UCPPS, as well as other concomitant NUAS.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Urology, Division of Neurourology and Pelvic Reconstructive Surgery, University of Michigan, Ann Arbor, MI, USA. qclemens@med.umich.edu.

ABSTRACT

Background: The "Multidisciplinary Approach to the Study of Chronic Pelvic Pain" (MAPP) Research Network was established by the NIDDK to better understand the pathophysiology of urologic chronic pelvic pain syndromes (UCPPS), to inform future clinical trials and improve clinical care. The evolution, organization, and scientific scope of the MAPP Research Network, and the unique approach of the network's central study and common data elements are described.

Methods: The primary scientific protocol for the Trans-MAPP Epidemiology/Phenotyping (EP) Study comprises a multi-site, longitudinal observational study, including bi-weekly internet-based symptom assessments, following a comprehensive in-clinic deep-phenotyping array of urological symptoms, non-urological symptoms and psychosocial factors to evaluate men and women with UCPPS. Healthy controls, matched on sex and age, as well as "positive" controls meeting the non-urologic associated syndromes (NUAS) criteria for one or more of the target conditions of Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS) or Irritable Bowel Syndrome (IBS), were also evaluated. Additional, complementary studies addressing diverse hypotheses are integrated into the Trans-MAPP EP Study to provide a systemic characterization of study participants, including biomarker discovery studies of infectious agents, quantitative sensory testing, and structural and resting state neuroimaging and functional neurobiology studies. A highly novel effort to develop and assess clinically relevant animal models of UCPPS was also undertaken to allow improved translation between clinical and mechanistic studies. Recruitment into the central study occurred at six Discovery Sites in the United States, resulting in a total of 1,039 enrolled participants, exceeding the original targets. The biospecimen collection rate at baseline visits reached nearly 100%, and 279 participants underwent common neuroimaging through a standardized protocol. An extended follow-up study for 161 of the UCPPS participants is ongoing.

Discussion: The MAPP Research Network represents a novel, comprehensive approach to the study of UCPPS, as well as other concomitant NUAS. Findings are expected to provide significant advances in understanding UCPPS pathophysiology that will ultimately inform future clinical trials and lead to improvements in patient care. Furthermore, the structure and methodologies developed by the MAPP Network provide the foundation upon which future studies of other urologic or non-urologic disorders can be based.

Trial registration: ClinicalTrials.gov identifier: NCT01098279 "Chronic Pelvic Pain Study of Individuals with Diagnoses or Symptoms of Interstitial Cystitis and/or Chronic Prostatitis (MAPP-EP)". http://clinicaltrials.gov/show/NCT01098279.

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Related in: MedlinePlus

Data and Materials Flow Schematic: Left Panel (Data Coordinating Core (DCC) Database) and Right Panel (Tissue Analysis and Technology Core (TATC) Database).
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Related In: Results  -  Collection

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Figure 2: Data and Materials Flow Schematic: Left Panel (Data Coordinating Core (DCC) Database) and Right Panel (Tissue Analysis and Technology Core (TATC) Database).

Mentions: The DCC provides biostatistical design and analysis leadership for all studies, serves as the central site for electronic protocol and data management system development, web-based deployment of data capture tools, data acquisition and storage, and promotes network-wide quality assurance across all protocol-specific domains of data. The DCC also provides administrative and project coordination support, including development and maintenance of a public website (http://www.mappnetwork.org/). The TATC provides a central location for bio-specimen processing, storage, and analysis of blood, urine, and DNA samples. The TATC established and implemented standards for specimen collection, identification, and handling to promote consistent specimen collection procedures. DCC and TATC personnel conducted centralized coordinator training before initiating patient enrollment, with follow-up re-fresher training at periodic Steering Committee meetings. Standardized modular barcoded collection kits with specimen annotation forms for blood, urine, and cheek swab DNA were designed for use at all recruitment sites. The data-sharing model allows sites to enter material requests, specimen collection and shipment information through the DCC portal, with replication in real-time between both DCC and TATC databases (FigureĀ 2). Sites request kits via the DCC portal, following which the TATC sends a shipment of unlinked specimen kits, uniquely identified with a barcode system, to the site, which are individually linked through the DCC portal to a MAPP participant at the time of biospecimen collection. Blood specimens are shipped on the day of collection to the TATC for next day delivery; whereas cheek swab and urine specimens are temporary stored at the collection sites and batch-shipped to the TATC. At-home specimen collection is facilitated by participants, using barcoded collection materials and pre-labeled shipping containers for direct shipping to the TATC. Centralized processing at the TATC ensures standardized processing using best practice standards [25]. Derivative specimen aliquots are barcoded without participant identifying information, allowing for blinded discovery and validation projects. A rigorous series of identity management procedures were implemented between the DCC and TATC to ensure unambiguous links between specimen and participant data. Discovery sites submit specimen requests for research projects to the DCC. Sharing of real-time specimen inventory and annotation data between the TATC and DCC database allows full control by the DCC to match specimens with the required clinical data, and select specimens at the aliquot tube level. After selection by the DCC, a specimen distribution request is transferred to the TATC, triggering shipment to the discovery site. Real-time updates allow the DCC to monitor progress of distribution projects.


The MAPP research network: design, patient characterization and operations.

Landis JR, Williams DA, Lucia MS, Clauw DJ, Naliboff BD, Robinson NA, van Bokhoven A, Sutcliffe S, Schaeffer AJ, Rodriguez LV, Mayer EA, Lai HH, Krieger JN, Kreder KJ, Afari N, Andriole GL, Bradley CS, Griffith JW, Klumpp DJ, Hong BA, Lutgendorf SK, Buchwald D, Yang CC, Mackey S, Pontari MA, Hanno P, Kusek JW, Mullins C, Clemens JQ, MAPP Research Network Study Gro - BMC Urol (2014)

Data and Materials Flow Schematic: Left Panel (Data Coordinating Core (DCC) Database) and Right Panel (Tissue Analysis and Technology Core (TATC) Database).
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4126395&req=5

Figure 2: Data and Materials Flow Schematic: Left Panel (Data Coordinating Core (DCC) Database) and Right Panel (Tissue Analysis and Technology Core (TATC) Database).
Mentions: The DCC provides biostatistical design and analysis leadership for all studies, serves as the central site for electronic protocol and data management system development, web-based deployment of data capture tools, data acquisition and storage, and promotes network-wide quality assurance across all protocol-specific domains of data. The DCC also provides administrative and project coordination support, including development and maintenance of a public website (http://www.mappnetwork.org/). The TATC provides a central location for bio-specimen processing, storage, and analysis of blood, urine, and DNA samples. The TATC established and implemented standards for specimen collection, identification, and handling to promote consistent specimen collection procedures. DCC and TATC personnel conducted centralized coordinator training before initiating patient enrollment, with follow-up re-fresher training at periodic Steering Committee meetings. Standardized modular barcoded collection kits with specimen annotation forms for blood, urine, and cheek swab DNA were designed for use at all recruitment sites. The data-sharing model allows sites to enter material requests, specimen collection and shipment information through the DCC portal, with replication in real-time between both DCC and TATC databases (FigureĀ 2). Sites request kits via the DCC portal, following which the TATC sends a shipment of unlinked specimen kits, uniquely identified with a barcode system, to the site, which are individually linked through the DCC portal to a MAPP participant at the time of biospecimen collection. Blood specimens are shipped on the day of collection to the TATC for next day delivery; whereas cheek swab and urine specimens are temporary stored at the collection sites and batch-shipped to the TATC. At-home specimen collection is facilitated by participants, using barcoded collection materials and pre-labeled shipping containers for direct shipping to the TATC. Centralized processing at the TATC ensures standardized processing using best practice standards [25]. Derivative specimen aliquots are barcoded without participant identifying information, allowing for blinded discovery and validation projects. A rigorous series of identity management procedures were implemented between the DCC and TATC to ensure unambiguous links between specimen and participant data. Discovery sites submit specimen requests for research projects to the DCC. Sharing of real-time specimen inventory and annotation data between the TATC and DCC database allows full control by the DCC to match specimens with the required clinical data, and select specimens at the aliquot tube level. After selection by the DCC, a specimen distribution request is transferred to the TATC, triggering shipment to the discovery site. Real-time updates allow the DCC to monitor progress of distribution projects.

Bottom Line: A highly novel effort to develop and assess clinically relevant animal models of UCPPS was also undertaken to allow improved translation between clinical and mechanistic studies.An extended follow-up study for 161 of the UCPPS participants is ongoing.The MAPP Research Network represents a novel, comprehensive approach to the study of UCPPS, as well as other concomitant NUAS.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Urology, Division of Neurourology and Pelvic Reconstructive Surgery, University of Michigan, Ann Arbor, MI, USA. qclemens@med.umich.edu.

ABSTRACT

Background: The "Multidisciplinary Approach to the Study of Chronic Pelvic Pain" (MAPP) Research Network was established by the NIDDK to better understand the pathophysiology of urologic chronic pelvic pain syndromes (UCPPS), to inform future clinical trials and improve clinical care. The evolution, organization, and scientific scope of the MAPP Research Network, and the unique approach of the network's central study and common data elements are described.

Methods: The primary scientific protocol for the Trans-MAPP Epidemiology/Phenotyping (EP) Study comprises a multi-site, longitudinal observational study, including bi-weekly internet-based symptom assessments, following a comprehensive in-clinic deep-phenotyping array of urological symptoms, non-urological symptoms and psychosocial factors to evaluate men and women with UCPPS. Healthy controls, matched on sex and age, as well as "positive" controls meeting the non-urologic associated syndromes (NUAS) criteria for one or more of the target conditions of Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS) or Irritable Bowel Syndrome (IBS), were also evaluated. Additional, complementary studies addressing diverse hypotheses are integrated into the Trans-MAPP EP Study to provide a systemic characterization of study participants, including biomarker discovery studies of infectious agents, quantitative sensory testing, and structural and resting state neuroimaging and functional neurobiology studies. A highly novel effort to develop and assess clinically relevant animal models of UCPPS was also undertaken to allow improved translation between clinical and mechanistic studies. Recruitment into the central study occurred at six Discovery Sites in the United States, resulting in a total of 1,039 enrolled participants, exceeding the original targets. The biospecimen collection rate at baseline visits reached nearly 100%, and 279 participants underwent common neuroimaging through a standardized protocol. An extended follow-up study for 161 of the UCPPS participants is ongoing.

Discussion: The MAPP Research Network represents a novel, comprehensive approach to the study of UCPPS, as well as other concomitant NUAS. Findings are expected to provide significant advances in understanding UCPPS pathophysiology that will ultimately inform future clinical trials and lead to improvements in patient care. Furthermore, the structure and methodologies developed by the MAPP Network provide the foundation upon which future studies of other urologic or non-urologic disorders can be based.

Trial registration: ClinicalTrials.gov identifier: NCT01098279 "Chronic Pelvic Pain Study of Individuals with Diagnoses or Symptoms of Interstitial Cystitis and/or Chronic Prostatitis (MAPP-EP)". http://clinicaltrials.gov/show/NCT01098279.

Show MeSH
Related in: MedlinePlus