Sean D. Rundell

Association of Early Imaging for Back Pain With Clinical Outcomes in Older Adults

IMPORTANCE In contrast to the recommendations for younger adults, many guidelines allow for older adults with back pain to undergo imaging without waiting 4 to 6 weeks. However, early imaging may precipitate interventions that do not improve outcomes. OBJECTIVE To compare function and pain at the 12-month follow-up visit among older adults who received early imaging with those who did not receive early imaging after a new primary care visit for back pain without radiculopathy. DESIGN, SETTING, AND PARTICIPANTS Prospective cohort of 5239 patients 65 years or older with a new primary care visit for back pain (2011-2013) in 3 US health care systems. We matched controls 1:1 using propensity score matching of demographic and clinical characteristics, including diagnosis, pain severity, pain duration, functional status, and prior resource use. EXPOSURES Diagnostic imaging (plain films, computed tomography [CT], magnetic resonance imaging [MRI]) of the lumbar or thoracic spine within 6 weeks of the index visit. MAIN OUTCOME AND MEASURES PRIMARY OUTCOME back or leg pain-related disability measured by the modified Roland-Morris Disability Questionnaire (score range, 0-24; higher scores indicate greater disability) 12 months after enrollment. RESULTS Among the 5239 patients, 1174 had early radiographs and 349 had early MRI/CT. At 12 months, neither the early radiograph group nor the early MRI/CT group differed significantly from controls on the disability questionnaire. The mean score for patients who underwent early radiography was 8.54 vs 8.74 among the control group (difference, -0.10 [95% CI, -0.71 to 0.50]; mixed model, P = .36). The mean score for the early MRI/CT group was 9.81 vs 10.50 for the control group (difference,-0.51 [-1.62 to 0.60]; mixed model, P = .18). CONCLUSIONS AND RELEVANCE Among older adults with a new primary care visit for back pain, early imaging was not associated with better 1-year outcomes. The value of early diagnostic imaging in older adults for back pain without radiculopathy is uncertain.

A Systematic Review to Assess Comparative Effectiveness Studies in Epidural Steroid Injections for Lumbar Spinal Stenosis and to Estimate Reimbursement Amounts

To systematically appraise published comparative effectiveness evidence (clinical and economic) of epidural steroid injections (ESI) for lumbar spinal stenosis and to estimate Medicare reimbursement amounts for ESI procedures.

Patient Education Based on Principles of Cognitive Behavioral Therapy for a Patient With Persistent Low Back Pain: A Case Report

STUDY DESIGN Case report. BACKGROUND Cognitive behavioral therapy (CBT) is an effective intervention for patients with persistent pain. Recent research indicates that physical therapists self-perceive a lack of knowledge, skills, and time to provide this intervention. The purpose of this case report is to describe how specific CBT strategies can be integrated with multimodal physical therapist management of a patient with persistent low back pain. CASE DESCRIPTION The patient was a 70-year-old female with activity limitations of walking, standing, and forward bending. Oswestry Disability Questionnaire score was 19/50 and Fear-Avoidance Belief Questionnaire physical activity subscale was 23/24. The Low Back Activity Confidence Scale revealed 19%, 100%, and 84% for function, symptom self-regulation, and exercise, respectively. CBT-based patient education was provided in combination with manual therapy and exercise. CBT techniques included cognitive restructuring, goal setting, activity pacing, problem-solving strategies, graded exposure, encouraging exposure to pleasant experiences, and maintenance strategies. OUTCOMES The patient was discharged after 7 visits distributed over 21 weeks. Her Oswestry Disability Questionnaire score was reduced 10% and Fear-Avoidance Belief Questionnaire physical activity subscale score reduced 48%. On the Low Back Activity Confidence Scale the patients scores were 19%, 87%, and 94% for function, symptom self-regulation, and exercise, respectively. DISCUSSION This case report describes the use of CBT techniques during patient education by a physical therapist. The patient demonstrated clinically measurable and significant improvements in disability. Improvements in both self-efficacy beliefs related to exercise and activity avoidance beliefs were associated with improvement in disability. Additional research is needed to determine best practices for CBT-based patient education by physical therapists. LEVEL OF EVIDENCE Therapy, level 4.

Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory

BackgroundThe National Institutes of Health (NIH) Health Care Systems Research Collaboratory (NIH Collaboratory) seeks to produce generalizable knowledge about the conduct of pragmatic research in health systems. This analysis applied the PRECIS-2 pragmatic trial criteria to five NIH Collaboratory pragmatic trials to better understand 1) the pragmatic aspects of the design and implementation of treatments delivered in real world settings and 2) the usability of the PRECIS-2 criteria for assessing pragmatic features across studies and across time.Methods/DesignUsing the PRECIS-2 criteria, five pragmatic trials were each rated by eight raters. For each trial, we reviewed the original grant application and a required progress report written at the end of a 1-year planning period that included changes to the protocol or implementation approach. We calculated median scores and interrater reliability for each PRECIS domain and for the overall trial at both time points, as well as the differences in scores between the two time points. We also reviewed the rater comments associated with the scores.ResultsAll five trials were rated to be more pragmatic than explanatory, with comments indicating that raters generally perceived them to closely mirror routine clinical care across multiple domains. The PRECIS-2 domains for which the trials were, on average, rated as most pragmatic on the 1 to 5 scale at the conclusion of the planning period included primary analysis (mean = 4.7 (range = 4.5 to 4.9)), recruitment (4.3 (3.6 to 4.8)), eligibility (4.1 (3.4 to 4.8)), setting (4.1 (4.0 to 4.4)), follow-up (4.1 (3.4 to 4.9)), and primary outcome (4.1 (3.5 to 4.9)). On average, the less pragmatic domains were organization (3.3 (2.6 to 4.4)), flexibility of intervention delivery (3.5 (2.1-4.5)), and flexibility of intervention adherence (3.8 (2.8-4.5)). Interrater agreement was modest but statistically significant for four trials (Gwet’s AC1 statistic range 0.23 to 0.40) and the intraclass correlation coefficient ranged from 0.05 to 0.31. Rating challenges included assigning a single score for domains that may relate to both patients and care settings (that is, eligibility or recruitment) and determining to what extent aspects of complex research interventions differ from usual care.ConclusionsThese five trials in diverse healthcare settings were rated as highly pragmatic using the PRECIS-2 criteria. Applying the tool generated insightful discussion about real-world design decisions but also highlighted challenges using the tool. PRECIS-2 raters would benefit from additional guidance about how to rate the interwoven patient and practice-level considerations that arise in pragmatic trials.Trial registrationsClinicaltrials.gov trial registrations: NCT02019225, NCT01742065, NCT02015455, NCT02113592, NCT02063867.

Clinical outcomes of early and later physical therapist services for older adults with back pain.

BACKGROUND CONTEXT The timing of physical therapy (PT) services and its association with later function and pain are not clear, especially in older adults. PURPOSE The purpose of this study was to compare clinical outcomes of patients receiving early or later PT services with those not receiving PT among older adults presenting to primary care for a new visit for back pain. STUDY DESIGN/SETTING Prospective cohort study using the Back Pain Outcomes Using Longitudinal Data registry. PATIENT SAMPLE A total of 3,705 adults 65 years and older with a new visit for back pain were included. OUTCOME MEASURES The outcome measures were Roland-Morris Disability Questionnaire (RMDQ), Pain Numerical Rating Scales, and EuroQol-5D. METHODS We studied two phases of PT utilization: early (0-28 days) and later (3-6 months). At baseline, we selected the participants with complete 12 months of patient-reported outcomes and electronic medical record data. Early PT was defined as initiating PT less than or equal to 28 days from the index visit for back pain. The no early PT group consisted of patients with no PT, no injections, no surgery, and no chiropractic within 28 days. We restricted the later phase analysis to patients with pain greater than 2 of 10 and an RMDQ score greater than 4 to create a subsample of patients with continuing clinically important back pain. We defined later PT as initiating PT between 3 and 6 months after the index visit. The no later PT group consisted of patients without any PT during this time. We used propensity score matching followed by multiple linear regression to estimate the mean difference in outcome. Sensitivity analysis examined clinically important change and dose of PT use among the early PT group. RESULTS The early PT group had better functional status with an adjusted mean RMDQ of 1.1 points less than the no early PT group (95% confidence interval: -2.2, -0.1) and less back pain of -0.5 (-0.9, -0.1) at 12 months. There was no difference between early PT groups at 3 and 6 months. The odds of a 30% improvement in function or pain were not different between these matched groups at 12 months, but the early PT group had increased odds of a 50% improvement in function at 12 months (odds ratio: 1.58, 95% confidence interval: 1.04, 2.40). There was no difference between later groups at 12 months. Greater dose of PT use within the early PT group was associated with better functional status (p= .01). CONCLUSIONS We found that among older adults presenting to their primary care providers for a new episode of back pain, early referral to PT resulted in no or minimal differences in pain, function, or health-related quality at 3, 6, or 12 months compared with a matched group that did not receive early PT. Secondary analysis show that patients initiating early PT may be somewhat more likely to experience 50% improvement in function at 12 months.

Patient-Reported Outcomes Associated With Use of Physical Therapist Services by Older Adults With a New Visit for Back Pain

Background Among older adults, it is not clear how different types or amounts of physical therapy may be associated with improvements in back pain and function. Objective The study objective was to investigate the association between types or amounts of physical therapist services and 1-year outcomes among older adults with back pain. Design This was a prospective cohort study. Methods A total of 3,771 older adults who were enrolled in a cohort study and who had a new primary care visit for back pain participated. Physical therapy use was ascertained from electronic health records. The following patient-reported outcomes were collected over 12 months: back-related disability (Roland-Morris Disability Questionnaire) and back and leg pain intensity (11-point numerical rating scale). Marginal structural models were used to estimate average effects of different amounts of physical therapy use on disability and pain for all types of physical therapy and for active, passive, and manual physical therapy. Results A total of 1,285 participants (34.1%) received some physical therapy. There was no statistically significant gradient in relationships between physical therapy use and back-related disability score. The use of passive or manual therapy was not consistently associated with pain outcomes. Higher amounts of active physical therapy were associated with decreased back and leg pain and increased odds of clinically meaningful improvements in back and leg pain relative to results obtained with no active physical therapy. Limitations The fact that few participants had high amounts of physical therapy use limited precision and the ability to test for nonlinear relationships for the amount of use. Conclusions Higher amounts of active physical therapy were most consistently related to the greatest improvements in pain intensity; however, as with all observational studies, the results must be interpreted with caution.

Predictors of Persistent Disability and Back Pain in Older Adults with a New Episode of Care for Back Pain.

Objective To identify predictors of persistent disability and back pain in older adults. Design Prospective cohort study. Setting Back pain outcomes using longitudinal data registry. Subjects Five thousand two hundred twenty adults age 65 years and older with a new primary care visit for back pain. Methods Baseline measurements included: demographics, health, and back pain characteristics. We abstracted imaging findings from 348 radiology reports. The primary outcomes were the Roland-Morris Disability Questionnaire (RMDQ) and back pain intensity. We defined persistent disability as RMDQ of 4/24 or higher at both six and 12 months and persistent back pain as pain 3/10 or higher at both six and 12 months. Results There were 2,498 of 4,143 (60.3%) participants with persistent disability, and 2,099 of 4,144 (50.7%) had persistent back pain. Adjusted analyses showed the following characteristics most strongly predictive of persistent disability and persistent back pain: sex, race, worse baseline clinical characteristics of back pain, leg pain, back-related disability and duration of symptoms, smoking, anxiety symptoms, depressive symptoms, a history of falls, greater number of comorbidities, knee osteoarthritis, wide-spread pain syndromes, and an index diagnosis of lumbar spinal stenosis. Within the imaging data subset, central spinal stenosis was not associated with disability or pain. Conclusion We found that many predictors in older adults were similar to those for younger populations.

Incidence and Prevalence of Acute Kidney Injury During Multistage Ultramarathons.

Objective:Determine prevalence, incidence, and risk factors of acute kidney injury (AKI) during multistage ultramarathons. Design:Prospective observational cohort study. Setting:Jordanian Desert 2012; Atacama Desert, Chile 2012 and 2013; and Gobi Desert 2013 RacingThePlanet 250 km, 6-stage, ultramarathons. Participants:One hundred twenty-eight participants (384 measurements) from the Jordan (25, 19.5%), Gobi (35, 27.3%), 2012 Atacama (24, 18.8%), and 2013 Atacama (44, 34.4%) races. Interventions:Blood samples and weights were gathered and analyzed immediately after stage 1 (40 km), 3 (120 km), and 5 (225 km). Main Outcome Measures:Changes in serum creatinine (Cr), cumulative incidence, and prevalence of AKI were calculated for each stage with “risk of injury” defined as 1.5 × baseline Cr and “injury” defined as 2 × Cr. Results:Cumulative incidence of AKI was 41.4%. Stage 1 had 56 (43.8%) with risk of AKI and 24 (18.8%) with injury; in stage 3, 61 (47.7%) were at risk, 41 (32%) had injury; in stage 5, 62 (48.4%) runners were at risk and 36 (28.1%) had injury. Acute kidney injury was significantly associated with females [odds ratio (OR), 4.64; 95% confidence interval (CI), 2.07–10.37; P < 0.001], lower pack weight (OR, 0.71; 95% CI, 0.56–0.91; P < 0.007), and percentage weight loss (OR, 0.87; 95% CI, 0.78–0.97; P < 0.015). Lowest quintile of finishers was less likely to develop AKI (OR, 0.18; 95% CI, 0.04–0.78; P < 0.022). Conclusions:Prevalence of AKI was 63%–78% during multistage ultramarathons. Female sex, lower pack weight, and greater weight loss were associated with renal impairment.

Role of Health Services Research in Producing High-Value Rehabilitation Care

The concept of value is receiving greater attention in rehabilitation and the broader health care environment. The overall purpose of this article is to present a framework to help clinicians, researchers, educators, and policy makers better understand the role of health services research in developing and evaluating evidence on value in rehabilitation. Value in health care is a multidimensional concept and may be defined differently by various stakeholders, but assessing value typically involves considering a combination of several health and economic outcomes. However, health care stakeholders often lack sufficient information on these outcomes to make well-informed decisions. Health services approaches such as comparative effectiveness research, patient-centered outcomes research, and health economics assessments are some ways to evaluate value. The evidence generated from such studies directly informs decision making and health policy. Rehabilitation professionals have a great opportunity to increase their engagement in describing, evaluating, delivering, and disseminating high-value care, but there are several barriers they need to consider to be most successful. Embracing health services research best practices is essential for advancing appropriate rehabilitation practice, research, and policy and for addressing challenges to implementing high-value care.

Including patient-reported outcomes and patient-reported resource-use questionnaires in studies

RATIONALE More efficient and better informed healthcare systems are expected to have improved knowledge of the impact of interventions on patient outcomes and resources used by patients and providers in specific health conditions. OBJECTIVES To describe trends related to putting patients at the center of healthcare decision making, regulatory trends and best practice recommendations for developing high-quality patient-reported outcomes (PROs), and strategic issues related to including PROs in studies. MATERIALS AND METHODS We summarize PRO concepts, definitions, and broadly-accepted scientific standards for developing, assessing, and interpreting PROs. Three conceptual models are presented as examples for assessing PROs in relation to other outcomes. We discuss different perspectives for stakeholders, including regulatory issues pertaining to formal guidance for PRO development and for use in trials. We provide examples of PROs used in studies for assessing health outcomes in oncology and resource-use outcomes in low back pain patients. RESULTS Psychometric scientists working closely with multi-disciplinary teams and regulatory authorities have greatly improved the science of collecting, assessing, and understanding patient-reported outcomes in clinical trials. A simplified framework is presented for strategic considerations for including PROs in studies, such as the appropriate timing for PRO endpoints. Asking patients about their health status and/or use of resources improves our understanding of how interventions and care processes may impact their lives and their budgets. We provide examples from a back pain trial of patient-reported resource-use questionnaires for medicines taken and other services or products used by patients. CONCLUSIONS Healthcare stakeholders are placing increased emphasis on resource use and the impact of interventions on patients, including effects associated with diagnostic tests. Patient-reported outcomes are being used in clinical practice and in clinical research, supported by formal best-practice guidelines. Radiology has a role as an engaged stakeholder in the design, conduct, and interpretation of patient-based evidence, and in its relevance to health policy implementation.