Nctid:
NCT00000410
Payload:
{"FullStudy"=>{"Rank"=>498916, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000007405", "ConditionMeshTerm"=>"Intervertebral Disc Displacement"}, {"ConditionMeshId"=>"D000001416", "ConditionMeshTerm"=>"Back Pain"}, {"ConditionMeshId"=>"D000017116", "ConditionMeshTerm"=>"Low Back Pain"}, {"ConditionMeshId"=>"D000006547", "ConditionMeshTerm"=>"Hernia"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000010146", "ConditionAncestorTerm"=>"Pain"}, {"ConditionAncestorId"=>"D000009461", "ConditionAncestorTerm"=>"Neurologic Manifestations"}, {"ConditionAncestorId"=>"D000020763", "ConditionAncestorTerm"=>"Pathological Conditions, Anatomical"}, {"ConditionAncestorId"=>"D000013122", "ConditionAncestorTerm"=>"Spinal Diseases"}, {"ConditionAncestorId"=>"D000001847", "ConditionAncestorTerm"=>"Bone Diseases"}, {"ConditionAncestorId"=>"D000009140", "ConditionAncestorTerm"=>"Musculoskeletal Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M4714", "ConditionBrowseLeafName"=>"Back Pain", "ConditionBrowseLeafAsFound"=>"Back Pain", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M19433", "ConditionBrowseLeafName"=>"Low Back Pain", "ConditionBrowseLeafAsFound"=>"Low Back Pain", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9625", "ConditionBrowseLeafName"=>"Hernia", "ConditionBrowseLeafAsFound"=>"Herniation", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M6475", "ConditionBrowseLeafName"=>"Constriction, Pathologic", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10439", "ConditionBrowseLeafName"=>"Intervertebral Disc Displacement", "ConditionBrowseLeafAsFound"=>"Intervertebral Disc Herniation", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M15927", "ConditionBrowseLeafName"=>"Spinal Stenosis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15963", "ConditionBrowseLeafName"=>"Spondylolisthesis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13066", "ConditionBrowseLeafName"=>"Pain", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12404", "ConditionBrowseLeafName"=>"Neurologic Manifestations", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M22519", "ConditionBrowseLeafName"=>"Pathological Conditions, Anatomical", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15919", "ConditionBrowseLeafName"=>"Spinal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5126", "ConditionBrowseLeafName"=>"Bone Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12097", "ConditionBrowseLeafName"=>"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Musculoskeletal Diseases", "ConditionBrowseBranchAbbrev"=>"BC05"}, {"ConditionBrowseBranchName"=>"Nervous System Diseases", "ConditionBrowseBranchAbbrev"=>"BC10"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 4"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"501"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"March 2000"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"August 2015", "CompletionDateStruct"=>{"CompletionDate"=>"April 2015", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"August 3, 2015", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"August 4, 2015", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"April 2015", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Changes in health-related quality of life as measured by the SF-36 health status questionnaire", "PrimaryOutcomeTimeFrame"=>"Baseline, 6 wks, 3 and 6 mos, Annually thereafter"}]}, "SecondaryOutcomeList"=>{"SecondaryOutcome"=>[{"SecondaryOutcomeMeasure"=>"Patient satisfaction with treatment", "SecondaryOutcomeTimeFrame"=>"Baseline, 6 wks, 3 mos, Annually thereafter"}, {"SecondaryOutcomeMeasure"=>"utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost effectiveness", "SecondaryOutcomeTimeFrame"=>"Baseline, 1 yr, 4 yr"}, {"SecondaryOutcomeMeasure"=>"resource utilization", "SecondaryOutcomeTimeFrame"=>"Baseline, 6 wks, 3 and 6 mos, Annually thereafter"}, {"SecondaryOutcomeMeasure"=>"cost", "SecondaryOutcomeTimeFrame"=>"Baseline, 6 wks, 3 and 6 mos, Annually thereafter"}]}}, "OversightModule"=>{"OversightHasDMC"=>"Yes"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Intervertebral disc herniation (IDH)", "Stenosis with degenerative spondylolisthesis (DS)", "Spinal stenosis (SpS)", "Low back pain (LBP)", "Leg pain", "Surgical therapy", "Non-surgical therapy", "Randomized study", "Multicenter", "MRI"]}, "ConditionList"=>{"Condition"=>["Herniated Disc", "Low Back Pain"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"12065987", "ReferenceType"=>"background", "ReferenceCitation"=>"Birkmeyer NJ, Weinstein JN, Tosteson AN, Tosteson TD, Skinner JS, Lurie JD, Deyo R, Wennberg JE. Design of the Spine Patient outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2002 Jun 15;27(12):1361-72. doi: 10.1097/00007632-200206150-00020."}, {"ReferencePMID"=>"10787504", "ReferenceType"=>"background", "ReferenceCitation"=>"Weinstein JN, Brown PW, Hanscom B, Walsh T, Nelson EC. Designing an ambulatory clinical practice for outcomes improvement: from vision to reality--the Spine Center at Dartmouth-Hitchcock, year one. Qual Manag Health Care. 2000 Winter;8(2):1-20. doi: 10.1097/00019514-200008020-00003."}, {"ReferencePMID"=>"14520044", "ReferenceType"=>"background", "ReferenceCitation"=>"Fanciullo GJ, Hanscom B, Weinstein JN, Chawarski MC, Jamison RN, Baird JC. Cluster analysis classification of SF-36 profiles for patients with spinal pain. Spine (Phila Pa 1976). 2003 Oct 1;28(19):2276-82. doi: 10.1097/01.BRS.0000084880.33281.EB."}, {"ReferencePMID"=>"12897482", "ReferenceType"=>"background", "ReferenceCitation"=>"Phillips FM, An H, Kang JD, Boden SD, Weinstein J. Biologic treatment for intervertebral disc degeneration: summary statement. Spine (Phila Pa 1976). 2003 Aug 1;28(15 Suppl):S99. doi: 10.1097/01.BRS.0000076906.82028.03."}, {"ReferencePMID"=>"12642770", "ReferenceType"=>"background", "ReferenceCitation"=>"Walsh TL, Hanscom B, Lurie JD, Weinstein JN. Is a condition-specific instrument for patients with low back pain/leg symptoms really necessary? The responsiveness of the Oswestry Disability Index, MODEMS, and the SF-36. Spine (Phila Pa 1976). 2003 Mar 15;28(6):607-15. doi: 10.1097/01.BRS.0000050654.97387.DF."}, {"ReferencePMID"=>"17119141", "ReferenceType"=>"result", "ReferenceCitation"=>"Weinstein JN, Lurie JD, Tosteson TD, Skinner JS, Hanscom B, Tosteson AN, Herkowitz H, Fischgrund J, Cammisa FP, Albert T, Deyo RA. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT) observational cohort. JAMA. 2006 Nov 22;296(20):2451-9. doi: 10.1001/jama.296.20.2451."}, {"ReferencePMID"=>"17119140", "ReferenceType"=>"result", "ReferenceCitation"=>"Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Hanscom B, Skinner JS, Abdu WA, Hilibrand AS, Boden SD, Deyo RA. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. 2006 Nov 22;296(20):2441-50. doi: 10.1001/jama.296.20.2441."}, {"ReferencePMID"=>"19018250", "ReferenceType"=>"result", "ReferenceCitation"=>"Weinstein JN, Lurie JD, Tosteson TD, Tosteson AN, Blood EA, Abdu WA, Herkowitz H, Hilibrand A, Albert T, Fischgrund J. Surgical versus nonoperative treatment for lumbar disc herniation: four-year results for the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Dec 1;33(25):2789-800. doi: 10.1097/BRS.0b013e31818ed8f4."}, {"ReferencePMID"=>"18777603", "ReferenceType"=>"result", "ReferenceCitation"=>"Tosteson AN, Skinner JS, Tosteson TD, Lurie JD, Andersson GB, Berven S, Grove MR, Hanscom B, Blood EA, Weinstein JN. The cost effectiveness of surgical versus nonoperative treatment for lumbar disc herniation over two years: evidence from the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Sep 1;33(19):2108-15. doi: 10.1097/brs.0b013e318182e390."}, {"ReferencePMID"=>"22048651", "ReferenceType"=>"result", "ReferenceCitation"=>"Tosteson AN, Tosteson TD, Lurie JD, Abdu W, Herkowitz H, Andersson G, Albert T, Bridwell K, Zhao W, Grove MR, Weinstein MC, Weinstein JN. Comparative effectiveness evidence from the spine patient outcomes research trial: surgical versus nonoperative care for spinal stenosis, degenerative spondylolisthesis, and intervertebral disc herniation. Spine (Phila Pa 1976). 2011 Nov 15;36(24):2061-8. doi: 10.1097/BRS.0b013e318235457b."}, {"ReferencePMID"=>"22791040", "ReferenceType"=>"derived", "ReferenceCitation"=>"Desai A, Bekelis K, Ball PA, Lurie J, Mirza SK, Tosteson TD, Zhao W, Weinstein JN. Spine patient outcomes research trial: do outcomes vary across centers for surgery for lumbar disc herniation? Neurosurgery. 2012 Oct;71(4):833-42. doi: 10.1227/NEU.0b013e31826772cb."}, {"ReferencePMID"=>"21971123", "ReferenceType"=>"derived", "ReferenceCitation"=>"Desai A, Ball PA, Bekelis K, Lurie J, Mirza SK, Tosteson TD, Zhao W, Weinstein JN. Surgery for lumbar degenerative spondylolisthesis in Spine Patient Outcomes Research Trial: does incidental durotomy affect outcome? Spine (Phila Pa 1976). 2012 Mar 1;37(5):406-13. doi: 10.1097/BRS.0b013e3182349bc5."}, {"ReferencePMID"=>"21311402", "ReferenceType"=>"derived", "ReferenceCitation"=>"Olson PR, Lurie JD, Frymoyer J, Walsh T, Zhao W, Morgan TS, Abdu WA, Weinstein JN. Lumbar disc herniation in the Spine Patient Outcomes Research Trial: does educational attainment impact outcome? Spine (Phila Pa 1976). 2011 Dec 15;36(26):2324-32. doi: 10.1097/BRS.0b013e31820bfb9a."}]}}, "DescriptionModule"=>{"BriefSummary"=>"This study tests the effectiveness of different treatments for the three most commonly diagnosed lumbar (lower) spine conditions. The purpose of the study is to learn which of two commonly prescribed treatments (surgery and non-surgical therapy) works better for specific types of low back pain.\n\nIn this part of the study, people with lumbar intervertebral disc herniation (damage to the tissue between the bones of the lower spine, or backbone) will receive either discectomy (surgical removal of herniated disc material) or non-surgical treatment. This study does not cover the cost of treatment.", "DetailedDescription"=>"Low back pain is considered one of the most widely experienced health problems in the United States and the world. This condition is the second most frequent condition, after the common cold, for which people see a physician or lose days from work. Estimated costs to those who are severely disabled from low back pain range from $30-70 billion annually. Rates of spinal surgery in the U.S. have increased sharply over time, and researchers have documented 15-fold geographic variation in rates of these surgeries. In many cases, where one lives and who one sees for the problem appear to determine the rates of surgery. Despite these trends, there is little evidence proving the effectiveness of these therapies over non-surgical management.\n\nOverall, the SPORT study is a multicenter, randomized, controlled trial for the three most common diagnostic groups for which spine surgery is performed: lumbar intervertebral disc herniation (IDH), spinal stenosis (SpS) and spinal stenosis secondary to degenerative spondylolisthesis (DS). This arm of the trial will deal with patients from the first diagnostic group. The study will compare the most commonly used standard surgical treatments to the most commonly used standard non-surgical treatments. We will conduct the study at 12 sites throughout the United States.\n\nThe primary endpoint of the study will be changes in health-related quality of life as measured by the SF-36 health status questionnaire. Secondary endpoints will include patient satisfaction with treatment, utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost-effectiveness, resource use, and cost.\n\nWe will follow patients at 6 weeks and 3, 6, 12, and 24 months to determine their health status, function, satisfaction, and use of health care. In this arm of the trial, we anticipate enrolling and randomly allocating a total of 500 participants. We will track an additional observational cohort to assess health and resource outcomes (1000 participants). Enrollment in the Observational cohort has been completed as of February 2003.\n\nWe will integrate data from the trial and observational cohorts to formally estimate the cost-effectiveness of surgical versus non-surgical interventions for IDH, SpS, and DS. On the basis of the results of this trial we will, for the first time, have scientific evidence as to the relative effectiveness of surgical versus non-surgical treatment for these three most commonly diagnosed lumbar spine conditions."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nDuration of symptoms: 6 or more weeks.\nTreatments tried: Non-steroidal anti-inflammatory medical therapy and physical therapy.\nSurgical screening: Persistent radicular pain provoked by moderate exercise, sitting, increased abdominal pressure, decreased mobility, list (scoliosis), straight leg raising.\nTests: MRI to confirm diagnosis and level(s).\n\nExclusion Criteria:\n\nPrevious lumbar spine surgery.\nNot a surgical candidate for any of these reasons: Overall health which makes spinal surgery too life-threatening to be an appropriate alternative, dramatic improvement with conservative care, or inability (for any reason) to undergo surgery within 6 months.\nPossible pregnancy.\nActive malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer) is ineligible unless he or she has been treated with a curative intent AND there has been no clinical signs or symptoms of the malignancy for at least 5 years.\nCurrent fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine.\nAge less than 18 years.\nCauda Equina syndrome or progressive neurological deficit (usually requiring urgent surgery).\nUnavailability for follow-up (planning to move, no telephone, etc.) or inability to complete data surveys.\nSymptoms less than 6 weeks.\nPatient currently enrolled in any experimental \"spine related\" study."}, "IdentificationModule"=>{"NCTId"=>"NCT00000410", "Acronym"=>"SPORT", "BriefTitle"=>"Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"Dartmouth-Hitchcock Medical Center"}, "OfficialTitle"=>"Spine Patient Outcomes Research Trial (SPORT): A Multicenter Randomized Trial for Intervertebral Disc Herniation (IDH)", "OrgStudyIdInfo"=>{"OrgStudyId"=>"U01 AR45444 NIAMS-004C"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"U01AR045444", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/U01AR045444", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"Surgery", "ArmGroupDescription"=>"Diskectomy", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Procedure: Diskectomy", "Procedure: Non-surgical treatments"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"Non-surgical intervention", "ArmGroupDescription"=>"Non-surgical treatments", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Procedure: Non-surgical treatments"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Diskectomy", "InterventionType"=>"Procedure", "InterventionDescription"=>"The surgeon will leave the nerve root freely mobile and undamaged following the procedure. During the procedure, the surgeon may consider using loop magnification or a microscope. The surgical incision will be midline and, after reflecting the paraspinous muscles, the interlaminar level will be identified and entered. The nerve root will be clearly identified and mobilized and then gently retracted to prepare for the discectomy. Removal of the medial border of the superior facet may, in some cases, be necessary in order to have a clear view of the lateral border of the involved nerve root. Following the clear view of the nerve root and mobilization, the IDH will be approached by making a small annular incision if necessary, the fragment of disc will then be removed (i.e., limited disc excision). A search of the canal will follow removal of the fragment, along with probing of the intervertebral-foramen for residual disc or bony pathology.", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Surgery"]}}, {"InterventionName"=>"Non-surgical treatments", "InterventionType"=>"Procedure", "InterventionDescription"=>"Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Non-surgical intervention", "Surgery"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"94612", "LocationCity"=>"Oakland", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Kaiser Permanente Spine Care Program"}, {"LocationZip"=>"94143-0728", "LocationCity"=>"San Francisco", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"University of California, San Francisco"}, {"LocationZip"=>"30033", "LocationCity"=>"Decatur", "LocationState"=>"Georgia", "LocationCountry"=>"United States", "LocationFacility"=>"The Emory Clinic, Emory University"}, {"LocationZip"=>"60612-3833", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Rush-Presbyterian, St. Luke's Medical Center"}, {"LocationZip"=>"04074", "LocationCity"=>"Scarborough", "LocationState"=>"Maine", "LocationCountry"=>"United States", "LocationFacility"=>"Maine Spine & Rehabilitation"}, {"LocationZip"=>"48073-9952", "LocationCity"=>"Royal Oak", "LocationState"=>"Michigan", "LocationCountry"=>"United States", "LocationFacility"=>"William Beaumont Hospital"}, {"LocationZip"=>"63110", "LocationCity"=>"St. Louis", "LocationState"=>"Missouri", "LocationCountry"=>"United States", "LocationFacility"=>"Washington University"}, {"LocationZip"=>"68154-4438", "LocationCity"=>"Omaha", "LocationState"=>"Nebraska", "LocationCountry"=>"United States", "LocationFacility"=>"Nebraska Foundation for Spinal Research"}, {"LocationZip"=>"03756", "LocationCity"=>"Lebanon", "LocationState"=>"New Hampshire", "LocationCountry"=>"United States", "LocationFacility"=>"Dartmouth-Hitchcock Medical Center - Spine Center"}, {"LocationZip"=>"10003", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"New York University, The Hospital for Joint Diseases"}, {"LocationZip"=>"10021", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Hospital for Special Surgery"}, {"LocationZip"=>"44106", "LocationCity"=>"Cleveland", "LocationState"=>"Ohio", "LocationCountry"=>"United States", "LocationFacility"=>"Case Western Reserve University"}, {"LocationZip"=>"19107-4216", "LocationCity"=>"Philadelphia", "LocationState"=>"Pennsylvania", "LocationCountry"=>"United States", "LocationFacility"=>"Rothman Institute at Thomas Jefferson Hospital"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"James N. Weinstein, DO, MS", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"Dartmouth-Hitchcock Medical Center"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"Dartmouth-Hitchcock Medical Center", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)", "CollaboratorClass"=>"NIH"}, {"CollaboratorName"=>"National Institute for Occupational Safety and Health (NIOSH/CDC)", "CollaboratorClass"=>"FED"}, {"CollaboratorName"=>"Office of Research on Women's Health (ORWH)", "CollaboratorClass"=>"NIH"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
