Theoretical Schemas to Guide Back Pain Consortium (BACPAC) Chronic Low Back Pain Clinical Research.

BACKGROUND: Chronic low back pain (cLBP) is a complex with a heterogenous clinical presentation. A better understanding of the factors that contribute to cLBP is needed for accurate diagnosis, optimal treatment, and identification of mechanistic targets for new therapies. The Back Pain Consortium (BACPAC) Research Program provides a unique opportunity in this regard, as it will generate large clinical datasets, including a diverse set of harmonized measurements. The Theoretical Model Working Group was established to guide BACPAC research and to organize new knowledge within a mechanistic framework. This article summarizes the initial work of the Theoretical Model Working Group. It includes a three-stage integration of expert opinion and an umbrella literature review of factors that affect cLBP severity and chronicity. METHODS: During Stage 1, experts from across BACPAC established a taxonomy for risk and prognostic factors (RPFs) and preliminary graphical depictions. During Stage 2, a separate team conducted a literature review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to establish working definitions, associated data elements, and overall strength of evidence for identified RPFs. These were subsequently integrated with expert opinion during Stage 3. RESULTS: The majority (∼80%) of RPFs had little strength-of-evidence confidence, whereas seven factors had substantial confidence for either a positive association with cLBP (pain-related anxiety, serum C-reactive protein, diabetes, and anticipatory/compensatory postural adjustments) or no association with cLBP (serum interleukin 1-beta / interleukin 6, transversus muscle morphology/activity, and quantitative sensory testing). CONCLUSION: This theoretical perspective will evolve over time as BACPAC investigators link empirical results to theory, challenge current ideas of the biopsychosocial model, and use a systems approach to develop tools and algorithms that disentangle the dynamic interactions among cLBP factors.

Development of an algorithm to assess unmeasured symptom severity in gynecologic care.

BACKGROUND: Healthcare disparities research is often limited by incomplete accounting for differences in health status by populations. In the United States, hysterectomy shows marked variation by race and geography, but it is difficult to understand what factors cause these variations without accounting for differences in the severity of gynecologic symptoms that drive the decision-making for hysterectomy. OBJECTIVE: This study aimed to demonstrate a method for using electronic health record-derived data to create composite symptom severity indices to more fully capture relevant markers that influence the decision for hysterectomy. STUDY DESIGN: This was a retrospective cohort study of 1993 women who underwent hysterectomy between April 4, 2014, and December 31, 2017, from 10 hospitals and >100 outpatient clinics in North Carolina. Electronic health record data, including billing, pharmacy, laboratory data, and free-text notes, were used to identify markers of 3 common indications for hysterectomy: bulk symptoms (pressure from uterine enlargement), vaginal bleeding, and pelvic pain. To develop weighted symptom indices, we finalized a scoring algorithm based on the relationship of each marker to an objective measure, in combination with clinical expertise, with the goal of composite symptom severity indices that had sufficient variation to be useful in comparing different patient groups and allow discrimination among severe symptoms of bulk, bleeding, or pain. RESULTS: The ranges of symptom severity scores varied across the 3 indices, including composite bulk score (0-14), vaginal bleeding score (0-44), and pain score (0-30). The mean values of each composite symptom severity index were greater for those who had diagnostic codes for vaginal bleeding, bulk symptoms, or pelvic pain, respectively. However, each index demonstrated a variation across the entire group of hysterectomy cases and identified symptoms that ranged in severity among those with and without the target diagnostic codes. CONCLUSION: Leveraging multisource data to create composite symptom severity indices provided greater discriminatory power to assess common gynecologic indications for hysterectomy. These methods can improve the understanding in healthcare use in the setting of long-standing inequities and be applied across populations to account for previously unexplained variations across race, geography, and other social indicators.

Short Versus Long InterTAN Fixation for Geriatric Intertrochanteric Hip Fractures: A Multicentre Head-to-Head Comparison.

OBJECTIVE: To determine if geriatric intertrochanteric hip fracture patients achieve equivalent postoperative functional status after management with either a short (180-200 mm) or a long (260-460 mm) InterTAN intramedullary device. DESIGN: Retrospective review of a prospective randomized control trial. SETTING: Four Level I Trauma Centers. PATIENTS/PARTICIPANTS: One hundred eight patients with OTA/AO classification 31A-1 and 31A-2 intertrochanteric hip fractures were included in the study. INTERVENTION: Internal fixation using an IT device. MAIN OUTCOMES MEASURES: Primary outcomes included Functional Independence Measure and Timed Up and Go. Secondary outcomes included blood loss, surgical time, length of stay, adverse events, and mortality. RESULTS: Seventy-one short and 37 long IT patients met study inclusion criteria. Demographics were similar between groups. There was no difference in Functional Independence Measure or Timed Up and Go scores between the 2 IT groups at any of the time points collected. Mean operative time was lower in the short IT group than in the long IT group (60 vs. 73 minutes; P = 0.021). A higher proportion of long IT patients had reamed constructs (95% vs. 48% short IT, P < 0.001). Postoperative blood loss was significantly higher in the long IT group without a significant influence on the number of patients requiring transfusion (P = 0.582) or average units transfused (P = 0.982). There was no significant difference in the proportion of postoperative adverse events between the 2 cohorts despite a higher number of peri-implant femur fractures in the short IT group than in the long IT group (5 vs. 1, P = 0.350). CONCLUSIONS: Postoperative functional status was not influenced by the length of IT device in the management of geriatric intertrochanteric hip fractures. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

A Multicenter Randomized Control Trial Comparing a Novel Intramedullary Device (InterTAN) Versus Conventional Treatment (Sliding Hip Screw) of Geriatric Hip Fractures.

OBJECTIVES: To compare outcomes in elderly patients with intertrochanteric hip fractures treated with either the sliding hip screw (SHS) or InterTAN intramedullary device (IT). DESIGN: Prospective, randomized, multicenter clinical trial. SETTING: Five level 1 trauma centers. PATIENTS: Two hundred forty-nine patients 55 years of age or older with AO/OTA 31A1 (43) and OA/OTA 31A2 (206) fractures were prospectively enrolled and followed for 12 months. INTERVENTION: Computer generated randomization to either IT (n = 123) or SHS (n = 126). MAIN OUTCOME MEASUREMENTS: The Functional Independence Measure (FIM) and the Timed Up and Go test (TUG) were used to measure function and motor performance. Secondary outcome measures included femoral shortening, complications, and mortality. RESULTS: Demographics, comorbidities, preinjury FIM scores and TUG scores were similar between groups. Patients (17.2%) who received an IT had limb shortening greater than 2 cm compared with 42.9% who received an SHS (P < 0.001). To determine the importance of preinjury function and fracture stability, we analyzed the subgroup of patients with the ability to walk 150 m independently preinjury and an OA/OTA 31A-2 fracture (n = 70). In this subgroup, patients treated with SHS had greater shortening and demonstrated poorer FIM and TUG scores compared with patients treated with an IT. CONCLUSIONS: Overall, most patients with intertrochanteric femur fractures can expect similar functional results whether treated with an intramedullary or extramedullary device. However, active, functional patients have an improved outcome when the InterTAN is used to treat their unstable intertrochanteric fracture. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

The prognosis of acute low back pain in primary care in the United States: a 2-year prospective cohort study.

STUDY DESIGN: Prospective cohort study. OBJECTIVE: To assess the prognosis of patients presenting with acute low back pain (LBP) in a primary care setting in the United States. SUMMARY OF BACKGROUND DATA: Practice guidelines for acute LBP based on return-to-work outcomes underestimate the development of chronic pain in the primary care setting. Because of differences in inclusion criteria, chronic pain definitions, and national health systems, prognostic cohort studies have reported a wide range of results limiting interpretation and generalization. Current data from carefully designed prognostic studies of acute LBP are lacking for the US primary care system. METHODS: Members of a large health service organization were enrolled after seeking medical care for acute LBP, with or without sciatica, of up to 30 days duration, with no episode in the past 12 months and no history of spine surgery. We conducted phone interviews at baseline, 6 months, and 2 years. Based on receiver operating characteristic analyses, a combination of global perceived recovery with pain intensity was used as primary outcome for chronic pain. Recurrence and multiple secondary outcomes were assessed to allow for comparison with other studies. RESULTS: Six hundred five patients had an average pain intensity of 5.6 (numeric rating scale = 0-10) and disability of 15.8 (Roland-Morris scale = 0-24). Eight percent had declared sick leave between pain onset and baseline interview. Thirteen percent of 521 patients (86% follow-up) experienced chronic pain at 6 months and 19% of 443 patients at 2 years. At 6 months, 54% had experienced at least 1 LBP recurrence, and 47% in the subsequent 18 months. CONCLUSION: The prognosis of strictly defined acute LBP, with or without sciatica, is less favorable than commonly stated in practice guidelines based on failure to return to work. Broad initiatives to develop new means for the primary and secondary prevention of recurrent and chronic LBP are urgently needed.

Acute low back pain and primary care: how to define recovery and chronification?

STUDY DESIGN: A prospective cohort study. OBJECTIVE: To establish outcome measures for recovery and chronic pain for studies with patients who present with recent-onset acute low back pain (LBP) in primary care. SUMMARY OF BACKGROUND DATA: Among back pain researchers, no consensus exists about outcome definitions or how to identify primary-care patients as not-recovered from an episode of LBP. Cut points for outcome scales have mostly been arbitrarily chosen. Theoretical models for establishing minimal important change values in studies of patients with LBP have been proposed and need to be applied to real data. METHODS: A sample of 521 patients who presented with acute LBP (<4 weeks) in primary care clinics were observed for 6 months and scores for pain and disability were compared with ratings on a Global Perceived Effect Scale. Using multiple potential "gold standards" as anchors (reference standards), the receiver operating characteristic method was used to determine optimal cut points for different ways of defining nonrecovery from acute LBP. RESULTS: Minimal important change values and upper limits for pain and disability scores as well as minimal important percentage changes are presented for five different definitions of recovery. A previously suggested 30% change from baseline scores does not accurately discriminate between recovered patients and nonrecovered patients in patients presenting with acute LBP in primary care. CONCLUSION: Outcome definitions that combine ratings from perceived recovery scales with pain and disability measures provide the highest accuracy in discriminating recovered patients from nonrecovered patients.

Antidepressant and antipsychotic use and adherence among Medicaid youths: differences by race.

The purpose of our study is to use Medicaid data to examine the relationship between race and (a) whether youth with schizophrenia or depression diagnoses receive anti-psychotic and antidepressant prescriptions and (b) adherence to anti-psychotics and antidepressants. The analysis is based on claims files from January 1, 2000 through June 30, 2001. To assess adherence, we used the Proportion of Days Covered (PDC) measure. Multivariable logistic regression was used to analyze the data. Black children with schizophrenia were significantly less likely to be adherent to anti-psychotics during a quarter than White children. White children with depression were significantly more likely to receive an antidepressant prescription and they were significantly more adherent during a quarter than Black children. Providers should make sure to investigate both youth and caregiver concerns, fears, and barriers to using these medications and work with the families to develop strategies to improve medication use among youth.

The data collection/data distribution center: building a sustainable African-American church-based research network.

BACKGROUND: This article describes the Carolina-Shaw Partnership for the Elimination of Health Disparities efforts to engage a diverse group of Black churches in a sustainable network. OBJECTIVES: We sought to develop a diverse network of 25 churches to work with the Carolina-Shaw Partnership to develop sustainable health disparities research, education, and intervention initiatives. METHODS: Churches were selected based on location, pastoral buy-in, and capacity to engage. A purposive sampling technique was applied. LESSONS LEARNED: (1) Collecting information on the location and characteristics of churches helps to identify and recruit churches that possess the desired qualities and characteristics. (2) The process used to identify, recruit, and select churches is time intensive. (3) The time, energy, and effort required managing an inter-institutional partnership and engage churches in health disparities research and interventions lends itself to sustainability. CONCLUSIONS: The development of a sustainable network of churches could lead to successful health disparities initiatives.

When race matters: disagreement in pain perception between patients and their physicians in primary care.

Patients and physicians often disagree in their assessment of pain intensity. This study explores the impact of patient factors on underestimation of pain intensity in chronic noncancer pain. We surveyed patients and their physicians in 12 primary care centers. To measure pain intensity, patients completed an 11-point numeric rating scale for which pain scores range from 0 (no pain) to 10 (unbearable pain). Physicians rated patients' pain on the same scale. We defined disagreement of pain intensity as underestimation or overestimation by 22 points. Of 601 patients approached, 463 (77%) completed the survey. The majority of participants were black (39%) or white (47%), 67% were female, and the mean age was 53 years. Physicians underestimated pain intensity relative to their patients 39% of the time. Forty-six percent agreed with their patients' pain perception, and 15% of physicians overestimated their patients' pain levels by > or =2 points. In both the bivariate and multivariable models, black race was a significant variable associated with underestimation of pain by physicians (p < 0.05; OR = 1.92; 95% CI: 1.31-2.81). This study finds that physicians are twice as likely to underestimate pain in blacks patients compared to all other ethnicities combined. A qualitative study exploring why physicians rate blacks patients' pain low is warranted.

The influence of discordance in pain assessment on the functional status of patients with chronic nonmalignant pain.

BACKGROUND: Chronic pain is a frequent cause of suffering and disability that seriously affects patients' quality of life and imposes a staggering socioeconomic toll on society. Little is known about the impact of patient-physician disagreement (discordance) regarding the assessment of chronic pain on patients' quality of life in primary care settings. This study evaluates the role of discordance and other potentially modifiable factors that affect the quality of life and functional status of chronic pain patients. METHODS: We evaluated 436 patient-physician encounters at 12 academic medical centers in the United States. We surveyed chronic nonmalignant pain patients to understand their pain perceptions. We concurrently surveyed their physicians about their perceptions of their patient's pain in primary care settings. RESULTS: More than 50% of physicians disagreed with their patient's pain. Thirty-nine percent of primary care physicians underestimated their patient's pain. In the multivariate analysis, this discordance was associated with poor physical functioning and worse bodily pain (P < 0.018 and P < 0.001 respectively). Patients with chronic, nonmalignant pain have reductions in physical function and bodily pain domains of the SF-36 compared to age-matched populations. Depression and obesity represented other associations. CONCLUSION: Patients with chronic nonmalignant pain have poor physical functioning and worse bodily pain. Discordance, obesity, and depression are other modifiable factors. Prospective studies are needed to design interventions. However, a multifaceted approach appears to represent the best opportunity to reduce the pain and suffering of this challenging population.

Racial differences in opioid use for chronic nonmalignant pain.

BACKGROUND: Chronic pain is a frequent cause of suffering and disability that negatively affects patients' quality of life. There is growing evidence that disparities in the treatment of pain occur because of differences in race. OBJECTIVE: To determine whether race plays a role in treatment decisions involving patients with chronic nonmalignant pain in a primary care population. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional survey was administered to patients with chronic nonmalignant pain and their treating physicians at 12 academic medical centers. We enrolled 463 patients with nonmalignant pain persisting for more than 3 consecutive months and the primary care physicians participating in their care. RESULTS: Analysis of the 397 black and white patients showed that blacks had significantly higher pain scores (6.7 on a scale of 0 to 10, 95% confidence interval (CI) 6.4 to 7.0) compared with whites (5.6, 95% CI 5.3 to 5.9); however, white patients were more likely to be taking opioid analgesics compared with blacks (45.7% vs 32.2%, P<.006). Even after controlling for potentially confounding variables, white patients were significantly more likely (odds ratio (OR) 2.67, 95% CI 1.71 to 4.15) to be taking opioid analgesics than black patients. There were no differences by race in the use of other treatment modalities such as physical therapy and nonsteroidal anti-inflammatories or in the use of specialty referral. CONCLUSION: Equal treatment by race occurs in nonopioid-related therapies, but white patients are more likely than black patients to be treated with opioids. Further studies are needed to better explain this racial difference and define its effect on patient outcomes.

Restricting patients' medication supply to one month: saving or wasting money?

PURPOSE: A state Medicaid program's pharmacy expenditures associated with dispensing one- and three-month supplies of drugs were examined. METHODS: We simulated the effect of a policy change from a maximum of a 100-day supply of prescription medication to one where only a 34-day supply was allowed. All North Carolina prescription claims from Medicaid enrollees who filled a prescription for at least one of six medication categories during fiscal years 1999 and 2000 were included. The six categories were angiotensin-converting-enzyme inhibitors, antiulcers, antipsychotics, nonsteroidal antiinflammatory drugs, selective serotonin-reuptake inhibitors, and sulfonylureas. The dollar value of the medication wasted, the amount of medication wastage diverted after a change to a shorter prescription length, and the total costs incurred by the increases in prescription refills were calculated. RESULTS: For each therapeutic category, 255,000-783,000 prescription drug claims were analyzed. No valid drug claims were excluded for any reason. Although 5-14% of total drug wastage, attributed to switches of drug therapy, could be saved by dispensing a 34-day supply, this saving could not make up for a larger increase in dispensing costs, as consumers would fill prescriptions more often. In addition, reducing the amount of drug dispensed each time may be costly to consumers through increased transportation and other expenses. CONCLUSION: Simulated calculation showed that the cost of drug therapy to North Carolina's Medicaid program would probably increase if 34-day rather than 100-day supplies of medications are dispensed to patients.