Table 5

Phase 3 Assessment Schedule

Assessment Month

0

1

3

6

12


Chronic Musculoskeletal Pain Patient Measures:

Pain and related disability (patient-reported, primary outcomes)

Pain Severity (BPI-SF subscale)

Pain Interference (BPI-SF subscale)

Pain Bothersomeness (single item)

Secondary Outcomes (survey instruments)

Overall well-being (Arizona Integrative Outcomes Scale)

Patient global impression of change

Quality of sleep (ISI)

Work- and activity-related impairment (NHIS questions)

Depression (PHQ-8)1

Anxiety (GAD-2)1

Quality of Life/health utility index (SF-12)

Patient satisfaction

Secondary outcomes (health care utilization collected through EMR and administrative records)

Overall use of healthcare services and associated costs

EMR2

EMR

EMR

EMR

Use of medications (short and long-acting opiates, sedatives, hypnotics, antidepressants)

EMR

EMR

EMR

EMR

Pain-related procedures (injections and imaging)

EMR

EMR

EMR

EMR

Pain-related visits (primary and specialty care)

EMR

EMR

EMR

EMR

ER/urgent care visits

EMR

EMR

EMR

EMR

Adverse events associated with conventional and CAM CMP treatment3

EMR

EMR

EMR

EMR

Use of health insurance reimbursed CAM

A4

A

A

A

Patient characteristics and potential moderators (including predisposing, enabling, and need factors associated with A/C use decision from Figure 1)

Demographics

Received/seeking pain-related disability compensation

Patient expectations/CAM attitudes

Other characteristics of pain condition (type(s)/duration)

Previous use of acupuncture/chiropractic services (adapted from NHIS survey)

Utilization of non-plan CAM health services & products

Healthcare Provider (Allopaths/Acupuncturists/Chiropractors) Measures:

Allopathic provider characteristics and CAM beliefs

Acupuncturist/chiropractic service provided & general practices


Note: 1depression and anxiety about pain will also be examined as potential moderators of pain outcomes; 2EMR = electronic medical record, 3participants will also be asked directly about CMP treatment-related adverse events; 4A = administrative record;

DeBar et al. BMC Complementary and Alternative Medicine 2011 11:118   doi:10.1186/1472-6882-11-118

Open Data