- Back Pain Outcomes Using Longitudinal Data cohort (BOLD)
- Lumbar Epidural Steroid injections for Spinal stenosis trial (LESS)
- Lumbar Imaging with Reporting of Epidemiology trial (LIRE)
- IBM Marketscan
- Centers for Medicaid and Medicare Services (CMS)
More information on datasets housed at the CLEAR Center, including data dictionaries, can be found below. To inquire about using these datasets, contact the CLEAR Center.
Back pain Outcomes using Longitudinal Data (BOLD)
Patients who enrolled in this registry completed validated, standardized measures of pain, back-related disability, and health-related quality of life at enrollment and at 3, 6, and 12 months. This was a prospective, geographically and racially diverse registry of older adult patients, an AHRQ priority population, with new episodes of low back pain recruited from four large health care systems across the nation. Patients were approached for registry enrollment when they were seen for back pain-related ICD9 codes within the past three weeks. 5,239 patients age 65 and older with new episodes of health care visits for back pain (defined as no prior visits to a health care provider for back pain care within 6 months) were recruited from both primary care clinics and urgent care/emergency care settings. In addition to patient encounters with physicians, patients who had encounters with non-physician primary care providers (registered nurses, nurse practitioners and physician assistants) were also included.
Demographic information and information regarding back pain duration and back pain recovery expectations at baseline were collected. The following measures were collected at each assessment: 1) Roland-Morris Disability Questionnaire (RDQ), modified slightly to indicate disability due to back or leg pain (sciatica) – the primary outcome measure; 2) 0–10 numerical rating scales (NRS) of average back and leg pain in past 7 days; 3) Brief Pain Inventory activity interference scale; 4) Patient Health Questionnaire (PHQ)-4 Depression and Anxiety screen; 5) the EuroQol-5D (EQ5D) 6) Behavioral Risk Factor Surveillance System (BRFSS) survey (2 questions about falls). In addition to the patient-reported outcome measures, queries of each health system’s electronic medical record and administrative systems were used to acquire demographic, pharmacy, laboratory, vital sign, and provider data for 3 years: 12 months prior to the study enrollment and 24 months following the index back pain visit.
Lumbar Epidural steroid injections for Spinal Stenosis (LESS)
The LESS study was a double-blind RCT of ESI plus local anesthetic injections versus local anesthetic injections for the treatment of pain associated with lumbar spinal stenosis in older adults. 400 older adults from 16 sites across the nation were recruited.
Patients with spinal stenosis referred for an ESI were asked if they would like to participate in the LESS trial. Prior to recruitment, the treating physician determined whether the patient was an appropriate candidate for ESI based on history, physical examination and imaging studies. All eligible patients that agreed to participate in the study were randomized into one of the two study arms: to receive steroid plus local anesthetic epidural injection or local anesthetic alone injection. The patients had opportunity to receive up four injections during the study participation: at baseline, 3, 6 and 9 weeks. At baseline demographic, clinical, and disease-history information were assessed and included patient self-report measures of pain, function, fear avoidance, and pain catastrophizing. In addition, patients were asked about their preferences for assignment to the ESI versus the control intervention, and to rate their expectations of pain relief. All medications used for pain were obtained from medical records and confirmed by patients via medication diaries. The primary outcomes were measures of function and pain, including the Roland-Morris Disability Questionnaire and leg pain measure recorded on an 11-point numerical rating scale (NRS). The primary outcome measures were completed at baseline, 3 days, 14 days, 3 weeks, 6 weeks, and 3, 6 and 12 months post-randomization.
Secondary outcome measures included the Brief Pain Inventory (BPI) Interference scale, the Patient Health Questionnaire (PHQ-8) measure of depression, Generalized Anxiety Disorder (GAD-7) measure, Swiss Spinal Stenosis Questionnaire (SSSQ), and the EQ-5D. These were administered at all follow-up time points with the exception that the SSSQ, BPI, PHQ-8, GAD-7 and EQ-5D were not administered at Days 3 and 14. The secondary outcome measures were collected at baseline, 3 and 6 weeks, 3, 6 and 12 months post-randomization. In addition, at baseline and at three weeks and six weeks post-injection, blood was drawn to measure HbA1c and fasting blood glucose and morning blood cortisol levels to monitor for hyperglycemia and adrenal suppression following steroid administration. Other measures included patient-completed resource utilization questionnaires to collect information on prescription and over-the-counter medication use, medical visits outside the health plan, and other patient burdens and costs during four 3-week periods throughout the 12-month study. Resource use and costs for utilization within each health system were collected through the electronic health information systems.
Lumbar Image Reporting with Epidemiology (LIRE)
The overall goal of the LIRE Pragmatic Trial was to perform a large, pragmatic, randomized controlled trial to determine the effectiveness of a simple, inexpensive and easy to deploy intervention – of inserting epidemiological benchmarks into lumbar spine imaging reports– at reducing subsequent tests and treatments (including cross-sectional imaging (MR/CT), opioid prescriptions, spinal injections and surgery). This NIH Collaboratory-funded pragmatic clinical trial included 250,401 participants and was conducted at 98 primary care clinics at four healthcare systems across the nation. Inclusion in the trial required that PCPs initiated one of 10 lumbar spine imaging (XR, CT, MR) CPT codes for evaluation of back pain. The intervention was inserting epidemiologic data into imaging reports using text that varied by imaging modality and patient age bracket. Intervention deployment was conducted using a stepped-wedge design with 5 randomization waves at the clinic level, spaced 6 months apart. Outcome data was passively collected via the electronic health record for a period spanning one year prior to index imaging to two years following index imaging. Utilization data include lumbar spine imaging reports, outpatient and inpatient encounters and diagnosis and procedure codes associated with those encounters, and prescriptions.
The CLEAR Center has access to the IBM/Watson (formerly Truven Health Analytics) MarketScan® Commercial Claims and Encounters Databases from 2007-2018. These databases provide researchers access to fully integrated, de-identified, individual-level healthcare claims data to understand health economics and treatment outcomes. These databases include procedures, diagnoses, and financial expenditures from inpatient, outpatient, and pharmacy claims of over 50 million enrollees (annually) with data from 150 contributing employers and 13 contributing health plans. Additionally, the CLEAR Center has access to the MarketScan® Medicare Supplemental Database from 2007-2018. This database profiles the healthcare experience of retirees with Medicare supplemental insurance paid by employers and provides detailed cost, use, and outcomes data for healthcare services performed in both inpatient and outpatient settings, including drug data.
Centers for Meidcaid and Medicare Services (CMS)
The CLEAR Center partners with the Harvey L. Neiman Health Policy Institute in Reston, Virginia to provide data from the Centers for Medicare and Medicaid Services (CMS) and analytic expertise. Through our collaboration, we are able to provide access to the CMS 5% research identifiable files (RIF), including the Carrier Fee-for Service file, which contains claims associated with a 5% national sample of Medicare enrollees. These data include procedures, diagnoses, and financial expenditures from inpatient and outpatient claims.