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STUDY DESIGN Observational cohort design involving measurement property assessment. OBJECTIVES The aim of this study was to assess construct validity through hypothesis testing and to examine reliability and discrimination of the PROMIS-29 v2.0 using item response theory (IRT) analyses. SUMMARY OF BACKGROUND DATA Patient-Reported Outcomes Measurement Information System (PROMIS) 29.0 version 2.0 includes 28 questions for the seven domains of Physical function, Anxiety, Depression, Fatigue, Sleep disturbance, Social role, and Pain interference, and one item related to pain intensity. To date, the tool has not been tested for construct validity for selected concepts, nor has it been evaluated using IRT in a population of spine surgery recipients. METHODS Using the Quality Outcomes Dataset lumbar registry, we evaluated the construct validity of the PROMIS-29 v2.0 against pain intensity measures for back and leg, the Oswestry Disability Index, the EQ5D 3L-visual analog scale (quality of life) and proxy measures of activities, mobility and self-care. IRT was used to test PROMIS-29 v2.0 assumptions and fit. RESULTS The sample included 652 surgery recipients (mean age = 60.1, SD = 14.0) who had a high level of baseline disability. Hypothesis testing confirmed direction and magnitude of correlation between the PROMIS and legacy measures in 10 of the 12 hypotheses. IRT identified three misfit items, but otherwise adequate scale reliability and unidimensionality. CONCLUSION The PROMIS-29 v2.0 measures several different constructs pertinent to a patient's health and recovery during spine surgery. We feel that the PROMIS-29 v2.0 tool is a useful and effective outcome measure for populations who receive spine surgery.Level of Evidence: 4.

Background Despite similar outcomes for surgery and conservative care, the number of surgeries to treat rotator cuff related shoulder pain has increased. Interventions designed to enhance treatment expectations for conservative care have been shown to improve patient expectations, but no studies have yet explored whether such interventions influence patient decisions to pursue surgery. The purpose of this randomized clinical trial is to examine the effect of an intervention designed to improve expectations of conservative care on the decision to have surgery. Methods We will test the effectiveness of the Patient Engagement, Education, and Restructuring of Cognitions (PEERC) intervention which is intended to change expectations regarding conservative care. The PEERC intervention will be evaluated in a randomized, pragmatic “add-on” trial, to better understand the effect the intervention has on outcomes. Ninety-four (94) participants with rotator cuff related shoulder pain referred for physical therapy will be randomized to receive either impairment-based care or impairment-based care plus PEERC. Both groups will receive impairment-based conservative treatment created by compiling the evidence associated with established, effective interventions. Participants assigned to the impairment-based care plus PEERC condition will also receive the PEERC intervention. This intervention, informed by principles of cognitive behavioral therapy, involves three components: (1) strategies to enhance engagement, (2) education and (3) cognitive restructuring and behavioral activation. Outcomes will be assessed at multiple points between enrolment and six months after discharge. The primary outcome is patient reported decision to have surgery and the secondary outcomes are pain, function, expectations and satisfaction with conservative care. Discussion Rotator cuff related shoulder pain is highly prevalent, and because conservative and surgical treatments have similar outcomes, an intervention that changes expectations about conservative care could alter patient reports of their decision to have surgery and ultimately could lead to lower healthcare costs and decreased risk of surgical complications. Trial registration This study is registered as NCT03353272 at ClincialTrials.gov.

Background Despite millions spent in research funding, studies, and guidelines, outcomes involving musculoskeletal care continue to decline. The purpose of this Viewpoint is to describe value-based care and to suggest measures for its adoption by physiotherapists who manage individuals with musculoskeletal related pain disorders. Discussion The provision of value-based care is best defined as care that includes: 1) patient centeredness, 2) guideline-oriented, integrated strategies, 3) measurement of patient outcomes and experiences, and 4) cost effectiveness. Physiotherapists are well positioned to be leaders in the application of value-based care by assuring they address each of the four strategies during the daily patient encounter. This Viewpoint discusses strategies for application to clinical practice. Conclusion By implementing value-based care principals, physiotherapists could assure that patients with musculoskeletal related pain disorders receive the right care at the right time, by the right provider.

Hypothesis/Background In 2017, the American Orthopaedic Association advocated for the increased use of telehealth as an assessment and treatment platform, and demand has significantly increased during the coronavirus disease 2019 pandemic. Diagnostic effectiveness (also called overall diagnostic accuracy) and reliability of a telehealth clinical examination vs. a traditional shoulder clinical examination (SCE) has not been established. Our objective is to compare the diagnostic effectiveness of a telehealth shoulder examination against an SCE for rotator cuff tear (RCT), using magnetic resonance imaging (MRI) as a reference standard; secondary objectives included assessing agreement between test platforms and validity of individualized tests. We hypothesize that tests provided in a telehealth platform would not have inferior diagnostic effectiveness to an SCE. Methods The study is a case-based, case-control design. Two clinicians selected movement, strength, and special tests for the SCE that are associated with the diagnosis of RCT and identified similar tests to replicate for a simulated telehealth-based examination (STE). Consecutive patients with no prior shoulder surgery or advanced imaging underwent both the SCE and STE in the same visit using 2 separate assessors. We randomized the order of the SCE or STE. A blinded reader assessed an MRI, to be used as a reference standard. We calculated diagnostic effectiveness, which provides values from 0% to 100% as well as agreement statistics (Kappa) between tests by an assessment platform, and sensitivity, specificity, and likelihood ratios for individual tests in both SCE and STE. We compared the diagnostic effectiveness (overall) of the SCE and STE with a Mann-Whitney U test. Results We included 62 consecutive patients with shoulder pain, aged 40 or older; 50 (81%) received an MRI as a reference standard. The diagnostic effectiveness of stand-alone tests was poor regardless of the group, with the exception of a few tests with high specificity. None had greater than 70% accuracy. There was no significant difference between the overall diagnostic effectiveness of the STE and SCE (P = .98). Overall agreement between the STE tests and the SCE tests ranged from poor to moderate (Kappa, 0.07-0.87). Conclusion This study identified initial feasibility and noninferiority of the physician-guided, patient-performed STE when compared with an SCE in the detection of RCTs. Although these results are promising, larger studies are needed for further validation of an STE assessment platform.

Background Injury is common in running and seen to impact up to 94% of recreational runners. Clinicians often use alterations from normal musculoskeletal clinical assessments to assess for risk of injury, but it is unclear if these assessments are associated with future injury. Objectives To identify alterations in muscle strength, flexibility, range of motion, and alignment that may predict lower extremity injury in runners. Methods Articles were selected following a comprehensive search of PubMed, Embase, CINAHL, and SPORTDiscus from database inception to May 2018. Included articles were prospective cohort studies, which specifically analyzed musculoskeletal impairments associated with future running-related injury. Two authors extracted study data, assessed the methodological quality of each study using the Critical Appraisal Tool and assessed the overall quality using the GRADE approach. Results Seven articles met the inclusion criteria. There was very low quality of evidence for the 7 identified clinical assessment alteration categories. Strong hip abductors were significantly associated with running-related injury in one study. Increased hip external-to-internal rotation strength and decreased hip internal range of motion were protective for running injury, each in one study. Decreased navicular drop in females had a protective effect for running-related injury in one study. Conclusions Due to very low quality of evidence for each assessment, confounders present within the studies, a limited number of studies, different measurement methods among studies, measurement variability within clinical assessments, inconsistent definitions of injury and runner, different statistical modeling, and study bias, caution is suggested in interpreting these results.

Background Prescription opioid use at high doses or over extended periods of time is associated with adverse outcomes, including dependency and abuse. The aim of this study was to identify mediating variables that predict chronic opioid use, defined as three or more prescriptions after orthopedic surgery. Methods Individuals were ages between 18 and 50 years and undergoing arthroscopic hip surgery between 2004 and 2013. Two categories of chronic opioid use were calculated based on individuals (1) having three or more unique opioid prescriptions within 2 years and (2) still receiving opioid prescriptions > 1 year after surgery. Univariate elationships were identified for each predictor variable, then significant variables (P > 0.15) were entered into a multivariate logistic regression model to identify the most parsimonious group of predictor variables for each chronic opioid use classification. Likelihood ratios were derived from the most robust groups of variables. Results There were 1642 participants (mean age 32.5 years, SD 8.2, 54.1% male). Nine predictor variables met the criteria after bivariate analysis for potential inclusion in each multivariate model. Eight variables: socioeconomic status (from enlisted rank family), prior use of opioid medication, prior use of non-opioid pain medication, high health-seeking behavior before surgery, a preoperative diagnosis of insomnia, mental health disorder, or substance abuse were all predictive of chronic opioid use in the final model (seven variables for three or more opioid prescriptions; four variables for opioid use still at 1 year; all

Background In 2019, a majority of runners participating in running events were female and 49% were of childbearing age. Studies have reported that women are initiating or returning to running after childbirth with up to 35% reporting pain. There are no studies exploring running-related pain or risk factors for this pain after childbirth in runners. Postpartum runners have a variety of biomechanical, musculoskeletal, and physiologic impairments from which to recover from when returning to high impact sports like running, which could influence initiating or returning to running. Therefore, the purpose of this study was to identify risk factors associated with running-related pain in postpartum runners with and without pain. This study also aimed to understand the compounding effects of multiple associative risk factors by developing a clinical decision tool to identify postpartum runners at higher risk for pain. Methods Postpartum runners with at least one child ≤36 months who ran once a week and postpartum runners unable to run because of pain, but identified as runners, were surveyed. Running variables (mileage, time to first postpartum run), postpartum variables (delivery type, breastfeeding, incontinence, sleep, fatigue, depression), and demographic information were collected. Risk factors for running-related pain were analyzed in bivariate regression models. Variables meeting criteria (P Results Analyses included 538 postpartum runners; 176 (32.7%) reporting running-related pain. Eleven variables were included in the multivariate model with six retained in the clinical decision tool: runner type-novice (OR 3.51; 95% CI 1.65, 7.48), postpartum accumulated fatigue score of >19 (OR 2.48; 95% CI 1.44, 4.28), previous running injury (OR 1.95; 95% CI 1.31, 2.91), vaginal delivery (OR 1.63; 95% CI 1.06, 2.50), incontinence (OR 1.95; 95% CI 1.31, 2.84) and Conclusion The results of this study provide a deeper understanding of the risk factors for running-related pain in postpartum runners. With this information, clinicians can monitor and educate postpartum runners initiating or returning to running. Education could include details of risk factors, combinations of factors for pain and strategies to mitigate risks. Coaches can adapt running workload accounting for fatigue and sleep fluctuations to optimize recovery and performance. Future longitudinal studies that follow asymptomatic postpartum women returning to running after childbirth over time should be performed to validate these findings.

Objectives Due to their potentially deleterious effects, minimizing the use of opioids for musculoskeletal pain is a priority for healthcare systems. The objective of this study was to examine the risk of future opioid prescription use based on prior opioid use within a non-surgical cohort with musculoskeletal knee pain. We also examined the risk of pre-existing comorbidities on future opioid use, and the risk of prior opioid use on future comorbidities (sleep, mental health, cardiometabolic disorders). Methods Data came from the Military Health System Data Repository for 80 290 consecutive beneficiaries with an initial episode of care for patellofemoral pain from January 1, 2010 through December 31, 2011. Risk was calculated using 2 × 2 tables based on pre- and post-opioid utilization and comorbid diagnosis. Risk ratios, relative and absolute risk increases, and numbers needed to harm were calculated, all with 95% confidence intervals. Results Prior opioid use resulted in a risk ratio of 18.0 (95 CI 17.1, 19.0) and an absolute risk increase of 61.6% for future opioid use (numbers needed to harm = 2). The presence of all comorbidities (except cardiometabolic syndrome) were associated with a significant relative risk for future opioid use (RR range 1.2-1.5), but the absolute risk increase was trivial (range 0.7%-2.2%). The relative risk for a chronic pain diagnosis, traumatic brain injury/concussion, insomnia, depression, and PTSD were all significantly higher in those with prior opioid use (1.3-1.6), but absolute risk increase was minimal (1.1%-6.5%). Discussion Prior opioid use was a strong risk factor for future opioid use in non-surgical patients with knee pain. These findings show that history of prior opioid use is important when assessing the risk of future opioid use, whereas prior comorbidities may not be as important. Opioid history assessment should be standard practice for all patients with patellofemoral pain in whom an opioid prescription is considered.

ObjectiveTelehealth has been established as a viable option for improved access and timeliness of care. Physician-guided patient self-evaluation may improve the viability of telehealth evaluation; however, there are little data evaluating the efficacy of self-administered examination (SAE). This study aims to compare the diagnostic accuracy of a patient SAE to a traditional standardised clinical examination (SCE) for evaluation of femoroacetabular impingement syndrome (FAIS).Methods75 patients seeking care for hip-related pain were included for participation. All patients underwent both SAE and SCE and were randomised to the order of the examinations. Diagnostic accuracy statistics were calculated for both examination group for a final diagnosis of FAIS. Mean diagnostic accuracy results for each group were then compared using Mann-Whitney U non-parametric tests.ResultsThe diagnostic accuracy of individual SAE and SCE manoeuvres varied widely. Both SAE and SCE demonstrated no to moderate change in post-test probability for the diagnosis of FAIS. Although low, SAE demonstrated a statistically greater mean diagnostic accuracy compared with the SCE (53.6% vs 45.5%, p=0.02).ConclusionDiagnostic accuracy was statistically significantly higher for the self-exam than for the traditional clinical exam although the difference may not be clinically relevant. Although the mean accuracy remains relatively low for both exams, these values are consistent with hip exam for FAIS reported in the literature. Having established the validity of an SAE, future investigations will need to evaluate implementation in a telehealth setting.

Background Several factors potentially influence outcomes of surgery, including perioperative complications. Complications may take many forms and the Clavien–Dindo (CD) classification is designed to categorize them by degree of severity. The aim of this study was to evaluate the influence of perioperative complications by severity categorization on the 1-and 2-year pain and disability outcomes for patients who received low back surgery. Materials and methods Data used for the study involved a purposive sample (N = 477; 8.1%) from a spine outcomes registry of 5876 patients who received spine surgery and encountered complications. All complications were categorized using the CD classification and were collapsed according to distribution frequencies, i.e., Grade I–II and Grade III–V. Adjusted and unadjusted regression analyses were used to determine the association between CD classification and 1- and 2-year outcomes. Results The majority of surgical complications were Grade III−V (N = 358; 75.1%), with two incidences in which death occurred. For the unadjusted models, there were no significant associations between CD classification categorizations for 1-year outcomes; however, 2-year outcomes were significantly worse (P

Background: This study describes a low‐cost and time‐efficient clinical sensory test (CST) battery and evaluates its concurrent validity as a screening tool to detect somatosensory dysfunction as determined using quantitative sensory testing (QST). Method: Three patient cohorts with carpal tunnel syndrome (CTS, n = 76), non‐specific neck and arm pain (NSNAP, n = 40) and lumbar radicular pain/radiculopathy (LR, n = 26) were included. The CST consisted of 13 tests, each corresponding to a QST parameter and evaluating a broad spectrum of sensory functions using thermal (coins, ice cube, hot test tube) and mechanical (cotton wool, von Frey hairs, tuning fork, toothpicks, thumb and eraser pressure) detection and pain thresholds testing both loss and gain of function. Agreement rate, statistical significance and strength of correlation (phi coefficient) between CST and QST parameters were calculated. Results: Several CST parameters (cold, warm and mechanical detection thresholds as well as cold and pressure pain thresholds) were significantly correlated with QST, with a majority demonstrating >60% agreement rates and moderate to relatively strong correlations. However, agreement varied among cohorts. Gain of function parameters showed stronger agreement in the CTS and LR cohorts, whereas loss of function parameters had better agreement in the NSNAP cohort. Other CST parameters (16 mN von Frey tests, vibration detection, heat and mechanical pain thresholds, wind‐up ratio) did not significantly correlate with QST. Conclusion: Some of the tests in the CST could help detect somatosensory dysfunction as determined with QST. Parts of the CST could therefore be used as a low‐cost screening tool in a clinical setting. Significance: Quantitative sensory testing, albeit considered the gold standard to evaluate somatosensory dysfunction, requires expensive equipment, specialized examiner training and substantial time commitment which challenges its use in a clinical setting. Our study describes a CST as a low‐cost and time‐efficient alternative. Some of the CST tools (cold, warm, mechanical detection thresholds; pressure pain thresholds) significantly correlated with the respective QST parameters, suggesting that they may be useful in a clinical setting to detect sensory dysfunction.

Key Points Question Is early physical therapy associated with long-term opioid use by patients with musculoskeletal pain? Findings In this cross-sectional analysis of 88 985 patients with shoulder, neck, knee, or low back pain, early physical therapy was associated with an approximately 10% statistically significant reduction in subsequent opioid use. Meaning By serving as an alternative or adjunct to short-term opioid use for patients with musculoskeletal pain, early physical therapy may play a role in reducing the risk of long-term opioid use., Importance Nonpharmacologic methods of reducing the risk of new chronic opioid use among patients with musculoskeletal pain are important given the burden of the opioid epidemic in the United States. Objective To determine the association between early physical therapy and subsequent opioid use in patients with new musculoskeletal pain diagnosis. Design, Setting, and Participants This cross-sectional analysis of health care insurance claims data between January 1, 2007, and December 31, 2015, included privately insured patients who presented with musculoskeletal pain to an outpatient physician office or an emergency department at various US facilities from January 1, 2008, to December 31, 2014. The sample comprised 88 985 opioid-naive patients aged 18 to 64 years with a new diagnosis of musculoskeletal shoulder, neck, knee, or low back pain. The data set (obtained from the IBM MarketScan Commercial database) included person-level International Classification of Diseases, Ninth Revision or Tenth Revision diagnosis codes, Current Procedural Terminology codes, and date of service as well as pharmaceutical information (National Drug Code, generic name, dose, and number of days supplied). Early physical therapy was defined as at least 1 session received within 90 days of the index date, the earliest date a relevant diagnosis was provided. Data analysis was conducted from March 1, 2018, to May 18, 2018. Main Outcomes and Measures Opioid use between 91 and 365 days after the index date. Results Of the 88 985 patients included, 51 351 (57.7%) were male and 37 634 (42.3%) were female with a mean (SD) age of 46 (11.0) years. Among these patients, 26 096 (29.3%) received early physical therapy. After adjusting for potential confounders, early physical therapy was associated with a statistically significant reduction in the incidence of any opioid use between 91 and 365 days after the index date for patients with shoulder pain (odds ratio [OR], 0.85; 95% CI, 0.77-0.95; P = .003), neck pain (OR, 0.92; 95% CI, 0.85-0.99; P = .03), knee pain (OR, 0.84; 95% CI, 0.77-0.91; P, This cross-sectional study examines the association between early physical therapy and subsequent opioid use among opioid-naive adults with a new diagnosis of musculoskeletal shoulder, neck, knee, or low back pain.

Background and Objective Central Sensitization (CS) is a phenomenon associated with several medical diagnoses, including post-cancer pain, low back pain, osteoarthritis, whiplash and fibromyalgia. CS involves an amplification of neural signaling within the central nervous system that results in pain hypersensitivity. The purpose of this systematic review was to gather published studies of a widely used outcome measure (the Central Sensitization Inventory [CSI]), determine the quality of evidence these publications reported, and examine the measurement properties of the CSI. Databases and Data Treatment Four databases were searched for publications from 2011 (when the CSI was developed) to July 2017. The Consensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was applied to evaluate methodological quality and risk of bias. In instances when COSMIN does not offer a scoring system for measurement properties, qualitative analyses were performed. Results Fourteen studies met inclusion criteria. Quality of evidence examined with COSMIN was determined to be good to excellent for all studies for their respective measurement property reports. Interpretability measures were consistent when publications were analyzed qualitatively and construct validity was strong when examined alongside other validated measures relating to CS. Conclusions An assessment of the published measurement studies of the CSI suggest the tool generates reliable and valid data that quantifies the severity of several symptoms of CS. This article is protected by copyright. All rights reserved.

Background Physical therapists’ familiarity, perceptions, and beliefs about health services utilization and health seeking behaviour have not been previously assessed. Objectives The purposes of this study were to identify physical therapists’ characteristics related to familiarity of health services utilization and health seeking behaviour, and to assess what health seeking behaviour factors providers felt were related to health services utilization. Methods We administered a survey based on the Andersen behavioural model of health services utilization to physical therapists using social media campaigns and email between March and June of 2017. In addition to descriptive statistics, we performed binomial logistic regression analysis. We asked respondents to rate familiarity with health services utilization and health seeking behaviour and collected additional characteristic variables. Results Physical therapists are more familiar with health services utilization than health seeking behaviour. Those who are familiar with either construct tend to be those who assess for health services utilization, use health services utilization for a prognosis, and believe that health seeking behaviour is measurable. Physical therapists rated need and enabling factors as having more influence on health services utilization than predisposing and health belief factors. Conclusion Physical therapists are generally familiar with health services utilization and health seeking behaviour; however, there appears to be a disconnect between what is familiar, what is perceived to be important, and what can be assessed for both health services utilization and health seeking behaviour.

Background The global burden of low back pain is growing rapidly, accompanied by increasing rates of associated healthcare utilization. Health seeking behavior (HSB) has been suggested as a mediator of healthcare utilization. The aims of this study were to: 1) develop a proxy HSB measure based on healthcare consumption patterns prior to initial consultation for spinal pain, and 2) examine associations between the proxy HSB measure and future healthcare utilization in a population of patients with spine disorders. Methods A cohort of 1,691 patients seeking care for spinal pain at a single military hospital were included. Cluster analyses were performed for the identification of a proxy HSB measure. Logistic regression was used to identify the predictive capacity of HSB on eight different general and spine-related high healthcare utilization (upper 25%) outcomes variables. Results The strongest proxy measure of HSB was prior primary care provider visits. In unadjusted models, HSB predicted healthcare utilization across all eight general and spine-related outcome variables. After adjusting for covariates, HSB still predicted general and spine-related healthcare utilization for most variables including total medical visits (OR = 2.48, 95%CI 1.09,3.11), total medical costs (OR = 2.72, 95%CI 2.16,3.41), and low back pain-specific costs (OR = 1.31, 95%CI 1.00,1.70). Conclusion Health seeking behavior prior to initial consultation for spine pain was related to healthcare utilization after consultation for spine pain. HSB may be an important variable to consider when developing an individualized care plan and considering the prognosis of a patient.

Yannick Tousignant-Laflamme,1,2 Marc Olivier Martel,3 Anand B Joshi,4 Chad E Cook5 1School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, QC, Canada; 2Clinicial Research Center of the Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada; 3Faculties of Dentistry& Medicine, McGill University, Montreal, QC, Canada; 4Duke Health, Department of Orthopaedic Surgery, Duke University Medical Center, 5Doctor of Physical Therapy Division, Duke University, Durham, NC, USA Abstract: In the past, rehabilitation research initiatives for low back pain (LBP) have targeted outcome enhancement through personalized treatment approaches, namely through classification systems (CS). Although the use of CS has enhanced outcomes, common management practices have not changed, the prevalence of LBP is still high, and only selected patients meet the CS profile, namely those with a nociceptive context. Similarly, although practice guidelines propose some level of organization and occasionally a timeline of care provision, each mainly provides best practice for isolated treatment approaches. Moreover, there is no theoretical framework that has been proposed that guides the rehabilitation management process of mechanical LBP. In this commentary, we propose a model constituted of five domains (nociceptive drivers, nervous system dysfunction drivers, comorbidities drivers, cognitive–emotional drivers, and contextual drivers) grounded as mechanisms driving pain and/or disability in LBP. Each domain is linked to the International Classification of Functioning, Disability and Health, where once a patient is deemed suitable for rehabilitation, the clinician assesses elements of each domain in order to identify where the relative treatment efforts should be focused. This theoretical model is designed to provide a more comprehensive management overview, by appreciating the relative contribution of each domain driving pain and disability. Considering that the multiple domains driving pain and disability, and their interaction, requires a model that is comprehensive enough to identify and address each related issue, we consider that the proposed model has several positive implications for rehabilitation of this painful and highly prevalent musculoskeletal disorder. Keywords: low back pain, spine, rehabilitation, pain management

Given the scale and cost of the low back pain problem, it is imperative that healthcare professionals involved in the care of people with low back pain have access to up-to-date, evidence-based information to assist them in treatment decision-making. Clinical guidelines exist to promote the consistent best practice, to reduce unwarranted variation and to reduce the use of low-value interventions in patient care. Recent decades have witnessed the publication of a number of such guidelines. In this narrative review, we consider three selected international interdisciplinary guidelines for the management of low back pain. Guideline development methods, consistent recommendations and inconsistencies between these guidelines are critically discussed.

Clinical trial registration involves placing the protocol for a clinical trial on a free, publicly available, and electronically searchable register. Registration is considered to be prospective if the protocol is registered before the trial commences (ie, before the first participant is enrolled). Prospective registration has several potential advantages. It could help avoid trials being duplicated unnecessarily and it could allow people with health problems to identify trials in which they might participate. Perhaps more importantly, however, it tackles 2 big problems in clinical research: selective reporting and publication bias. Prospective clinical trial registration is of great potential value to the clinicians, consumers, and researchers who rely on clinical trial data, and that is why the International Society of Physiotherapy Journal Editors (ISPJE) is recommending that members enact a policy for prospective trial registration.

STUDY DESIGN: Retrospective cohort study using data from the Nationwide Inpatient Sample administrative data from 1988 through 2003. OBJECTIVE: To examine perioperative morbidity and mortality for patients with and without diabetes mellitus following lumbar spinal fusion. SUMMARY OF BACKGROUND DATA: Diabetes has been associated with worse outcomes in a variety of orthopedic procedures including spinal surgery. There is limited evidence that diabetic patients have more complications following lumbar fusion with little published data to support this conclusion. METHODS: Data from 197,461 patients who underwent lumbar fusion were included. Over 11,000 patients (5.6%) with a postoperative diagnosis of diabetes mellitus were identified. Selected variables were used for comparison of patients with and without diabetes. Bivariate statistical analyses compared postoperative complication rates while multivariate statistics were used to determine likelihood of complications with diabetes. RESULTS: Bivariate analysis demonstrated that diabetes was significantly associated with postoperative infection, need for transfusion, pneumonia, in-hospital mortality, and nonroutine discharge (P

To compare the effect of manual therapy (MT) and an augmentative exercise programme (AEP) versus MT and general neck range of motion (ROM) on functional outcomes for patients with neck pain. A secondary objective was to examine changes in self-report measures and quantitative sensory testing (QST) following MT and AEP.This was a randomised clinical trial. Seventy-two patients with neck pain were recruited. All patients received a single session of MT. Patients were randomly assigned to MT+AEP or MT+ROM. Clinical self-report outcome measures for disability and pain, and QST measures (pain and vibration thresholds) were collected at baseline, post MT treatment, at ∼48 hours, and at ∼96 hours. Repeated measures ANOVA and MANOVA were used to analyse within and between-group effects for clinical and QST measures.There were no between-group differences for disability, pain and QST measures. There was, however, a significant difference between groups for Global Rating of Change (GRoC) scores (P = 0.037). Patients in both groups showed improvements in pain, disability and trapezius pressure-pain threshold (PPT) (all P 0.001).Augmentative exercise programme does not significantly improve disability, pain or QST measures in patients with chronic neck pain although it may enhance their GRoC scores. Over a 96-hour period, patients benefitted from MT plus exercise whether the exercise was general or specific.

Background In the domain of academia, the scholarship of research may include, but not limited to, peer-reviewed publications, presentations, or grant submissions. Programmatic research productivity is one of many measures of academic program reputation and ranking. Another measure or tool for quantifying learning success among physical therapists education programs in the USA is 100 % three year pass rates of graduates on the standardized National Physical Therapy Examination (NPTE). In this study, we endeavored to determine if there was an association between research productivity through artifacts and 100 % three year pass rates on the NPTE. Methods This observational study involved using pre-approved database exploration representing all accredited programs in the USA who graduated physical therapists during 2009, 2010 and 2011. Descriptive variables captured included raw research productivity artifacts such as peer reviewed publications and books, number of professional presentations, number of scholarly submissions, total grant dollars, and numbers of grants submitted. Descriptive statistics and comparisons (using chi square and t-tests) among program characteristics and research artifacts were calculated. Univariate logistic regression analyses, with appropriate control variables were used to determine associations between research artifacts and 100 % pass rates. Results Number of scholarly artifacts submitted, faculty with grants, and grant proposals submitted were significantly higher in programs with 100 % three year pass rates. However, after controlling for program characteristics such as grade point average, diversity percentage of cohort, public/private institution, and number of faculty, there were no significant associations between scholarly artifacts and 100 % three year pass rates. Conclusions Factors outside of research artifacts are likely better predictors for passing the NPTE.

The utility of a dedicated clinical test is dependent on the diagnostic accuracy values and the quality of the study in which the test was examined. Scales allow a summative scoring of bias within a study. At present, there are no scales advocated to measure the bias of diagnostic accuracy studies.The objective of this study was to create a new diagnostic accuracy quality scale (DAQS) that provides a quantitative summary of the methodological quality of studies evaluating clinical tests and measures.The study used a four-round Delphi survey designed to create, revise, and develop consensus for a quality scale.The four-round Delphi involved a work team and a respondent group of experts. An initial round among the work team created a working document, which was then modified and revised, with opportunities to create new items threaded in the second round. Rounds III and IV involved voting on the importance of each of the proposed items and consensus development from the respondent group. Consensus for the selection of an item required a 75% approval for the importance of that item.Sixteen individuals with a variety of research/professional backgrounds made up the respondent group. Modification and revision of the initial work team instrument created a scale with 21 items that reflected potential areas of methodological bias.The new scale needs validation through weighted assessment. In addition, there was a large proportion of physical therapist/researchers on the work team and the respondent group.Systematic reviews allow summation of evidence for clinical tests and scales are essential to critique the quality of the articles included in the review. The DAQS may serve this role for diagnostic accuracy studies.

Purpose: To investigate differences in pain and disability between patients treated with thrust manipulation (TM) and those treated with non-thrust manipulation (NTM) in a group of patients with mechanical low back pain (LBP) who had a within-session response to an initial assessment and met the clinical prediction rule (CPR). Methods: Data from 71 patients who met the CPR were extracted from a database of patients in a larger randomized controlled trial comparing TM and NTM. Treatment of the first two visits involved either TM or NTM (depending on allocation) and a standardized home exercise programme. Data analysis included descriptive statistics and a two-way ANOVA examining within- and between-groups effects for pain and disability, as well as total visits, total days in care, and rate of recovery. Results: No between-group differences in pain or disability were found for NTM versus TM groups (p=0.55), but within-subjects effects were noted for both groups (p

Minimal clinically important difference (MCID) scores for outcome measures are frequently used evidence-based guides to gage meaningful changes. There are numerous outcome instruments used for analyzing pain, disability, and dysfunction of the low back; perhaps the most common of these is the Oswestry disability index (ODI). A single agreed-upon MCID score for the ODI has yet to be established. What is also unknown is whether selected baseline variables will be universal predictors regardless of the MCID used for a particular outcome measure.To explore the relationship between predictive models and the MCID cutpoint on the ODI.Data were collected from 16 outpatient physical therapy clinics in 10 states.Secondary database analysis using backward stepwise deletion logistic regression of data from a randomized controlled trial (RCT) to create prognostic clinical prediction rules (CPR).One hundred and forty-nine patients with low back pain (LBP) were enrolled in the RCT. All were treated with manual therapy, with a majority also receiving spine-strengthening exercises.The resultant predictive models were dependent upon the MCID used and baseline sample characteristics. All CPR were statistically significant (P001). All six MCID cutpoints used resulted in completely different significant predictor variables with no predictor significant across all models.The primary limitations include sub-optimal sample size and study design.There is extreme variability among predictive models created using different MCIDs on the ODI within the same patient population. Our findings highlight the instability of predictive modeling, as these models are significantly affected by population baseline characteristics along with the MCID used. Clinicians must be aware of the fragility of CPR prior to applying each in clinical practice.

L'enregistrement des essais cliniques consiste a inclure un protocole d'essai clinique dans un registre electronique gratuit, accessible au public et dote d'un moteur de recherche. Un tel enregistrement est considere comme prospectif si le protocole est enregistre avant le debut de l'essai clinique (c.-a-d. avant que les participants soient recrutes). L'enregistrement prospectif comporte plusieurs avantages. Il permet d'eviter le dedoublement inutile des essais et aide les personnes qui souffrent de problemes de sante a savoir a quels essais ils pourraient participer. Mais plus important encore, ce type d'enregistrement permet de contourner deux obstacles importants : les rapports selectifs et les biais de publication. Les rapports selectifs surviennent lorsque les chercheurs n'utilisent que les resultats les plus favorables pour rediger le rapport qui servira a publier les resultats d'un essai, au lieu de consigner les resultats pour tous les elements qui ont fait l'objet d'une mesure. Faire etat uniquement des resultats favorables peut donner une fausse impression des effets d'une therapie dans la litterature existante. Imaginons par exemple qu'une intervention totalement inefficace soit testee dans le cadre de plusieurs essais et que chacun de ces essais permette de mesurer de multiples resultats. La plupart des resultats demontreront que l'intervention n'a aucun effet significatif. Toutefois, il peut arriver a l'occasion qu'un resultat demontre un avantage ou un prejudice significatifs par simple effet du hasard. Si les chercheurs publient les resultats positifs, mais ne publient pas les resultats non significatifs ou negatifs, les lecteurs pourraient en deduire erronement que l'intervention est benefique. Un probleme similaire pourrait survenir si les resultats sont analyses a de multiples points precis dans le temps. Les chercheurs pourraient mentionner dans leur rapport qu'une intervention peut ameliorer la vitesse de marche a 6 mois, et negliger de mentionner qu'elle n'a aucun effet sur cette vitesse a 1, 2, 3, 9, 12 et 24 mois. L'enregistrement prospectif des essais cliniques evite ce probleme de plusieurs facons. Les redacteurs en chef et les reviseurs de telles publications peuvent comparer l'etendue des resultats consignes dans un manuscrit aux resultats attendus precises dans le protocole enregistre au prealable, et demander que toute disparite soit eliminee en suivant le protocole prevu. Les lecteurs peuvent aussi comparer les resultats attendus inclus dans le protocole enregistre avec ceux du rapport publie, et s'assurer ainsi que ces resultats sont tout a fait coherents. Les biais de publication surviennent lorsque les essais qui comportent des resultats positifs ont plus de chance d'etre publies que les resultats non significatifs ou negatifs. Tout comme les rapports selectifs, une telle situation peut aussi surestimer faussement les effets apparents d'une intervention dans les donnees publiees. Un essai qui semble demontrer qu'une intervention semble efficace pourrait par exemple etre publie, alors que trois autres essais dans lesquels l'intervention parait inefficace ou nefaste dorment tout bonnement dans les classeurs des chercheurs. Si un essai est enregistre, mais jamais publie, les auteurs d'une revue systematique pourront quand meme le retrouver dans le registre et communiquer avec ses auteurs pour demander que les donnees non publiees soient incluses dans leur revue. L'enregistrement prospectif des essais cliniques peut donc limiter encore davantage les biais de publication qui pourraient influer sur le corpus de preuves disponible dans les essais publies du domaine de la physiotherapie. L'enregistrement prospectif des essais cliniques favorise la transparence1 et peut aussi faire en sorte qu'il soit plus difficile pour les auteurs frauduleux de forger des donnees. Ainsi, certaines revues demandent desormais que des donnees individuelles sur les patients soient systematiquement fournies aux fins de verification2 ou de verification des donnees dans le cas ou on soupconne une fraude.3 La collecte des donnees aurait du avoir lieu au cours de la periode de collecte des donnees precisees lors de l'enregistrement. Puisque de nombreux resultats sont mesures et consignes de maniere electronique avec date d'emission, cela augmenterait la planification et la complexite necessaires pour forger des donnees, surtout si l'objectif est que ces donnees fausses passent le test lors d'un examen rigoureux. De meme, les chercheurs qui obtiennent des donnees non desirees d'un sous-groupe particulier de patients pourraient etre tentes d'eliminer ces donnees en ajoutant apres coup un critere d'exclusion supplementaire. Si leur protocole a ete enregistre au prealable, cet ajout deviendrait evident pour quiconque comparerait le protocole enregistre et le rapport sur l'essai en question.

The Global Rating of Change Score (GRoC) is a frequently used outcome measure that is used independently to measure improvements in a patient’s condition or as an anchor for other outcomes measures. The tool has been criticized for recall bias, biases in administration, and for poor reliability over time. Our findings, captured from a sample of patients with shoulder impingement, suggest that all these concerns are of merit. Our results show poor correlation of the GRoC with functional measures after 2 and 3 weeks and decay of the associative stability of the GRoC from week to week.

In 1999, David Isaacs and Dominic Fitzgerald offered up seven alternatives to evidence-based practice when faced with a situation where no evidence exists on the topic at hand.1 Their jocular suggestions of (1) eminence-based medicine; (2) vehemence-based medicine; (3) eloquence-based medicine; (4) providence-based medicine; (5) diffidence-based medicine; (6) nervousness-based medicine; and (7) confidence-based medicine reflect the arrogance, nihilism, or lack of confidence displayed during decision making by physicians, nurses, and surgeons. Although meant to be funny, the editorial is decisively accurate and despite being over 10 years old it is not dated in context. Truly, these are the unsightly alternatives to evidence-based practice. I do think one alternative to evidence-based practice is conspicuously absent from this list. This alternative, which I call emotional-based practice, differs from Isaacs and Fitzgerald’s1 suggestions because emotional-based practice is utilized when evidence exists to refute the use of a specific test or intervention (not during a lack of evidence). In other words, the clinician has elected to use the test or intervention despite evidence to the contrary. They elect to do so because they are personally and emotionally attached to the test or intervention. But before we condemn emotional-based practice, let’s discuss how research is disseminated in clinical practice; because quite frankly, this is no easy task. Rogers’2 adoption/innovation curve (Fig. 1), which was first proposed in the late 1950s, has frequently been used as a model for dissemination of innovation or research. The innovation curve suggests that approximately 16% of those (a group called ‘laggards’ by Rogers) involved in the dedicated field (for example, manual therapy) will either be significantly delayed in their adoption of information or will never adopt the information. I think that the number is probably higher. Around 34% falls in the ‘late majority’ group, a group that has been described as a ‘skeptical’ population by others.3 A certain degree of skepticism in healthcare is constructive, as it delays the implementation of a poorly vetted clinical treatment. However, when evidence exists to refute the use of a specific test or intervention, skepticism loses its value. Figure 1 Innovation curve for dissemination of research. In defense of our colleagues who continue to use specific tests or interventions when evidence exists to refute the use, it is worth mentioning that up to 30 000 papers on biomedical literature are published yearly.4 Furthermore, folklore, myth, and information handed down over the generations have duped a number of healthcare professions and the lay public as a whole. For example, myths such as (1) people should drink eight glasses of water in a day to maintain good health; (2) we only use 10% of our brains during normal activities; (3) hair and fingernails continue to grow after death; and (4) reading in dim light ruins your eyesight are accepted as truisms, even though there is no evidence to support these claims.5 People still call chronic Achilles pain, lateral epicondylitis, and rotator cuff injuries ‘tendonitis’, despite that we have known for years that there is generally no inflammatory aspect to the processes.6 It is easy to see why there is the mistake in advocating certain tests or treatment, if we have misinformation. However, when one knows that evidence exists to refute the use of a specific test or intervention, yet he/she elects to use these procedures anyway; that is, emotional-based practice. I would argue that this is the most significant problem that delays our pursuit of evidence in support of manual therapy. I have encountered emotional-based practice a number of times over my 20 years of a clinician but have noticed the feverishness of this more so in the last 3–5 years as evidence has grown and has become more prominent in clinical practice. Specifically, I have witnessed an emotional attachment to particular orthopedic manual therapy procedures (‘fix all’ procedures), orthopedic special tests, screening tests, and diagnoses. Let’s consider the following clinical examples: (1) the use of the straight leg raise (SLR) as confirmatory diagnostic test for a disc herniation; (2) allowing a clinical prediction rule (CPR) to trump clinical reasoning that refutes proper use; and (3) the continued insistence that palpation tests of the sacroiliac joint are diagnostic for sacroiliac joint syndrome.

Background: Case reports and small case series suggest that women with von Willebrand disease (VWD) are at a very high risk of bleeding complications with hysterectomy. Because the procedure may be beneficial to women who suffer from heavy menstrual bleeding, an understanding of the true risks involved is essential for appropriate decision making. Objectives: To estimate the incidence of bleeding and other complications in women with VWD who undergo hysterectomy. Methods: The United States Nationwide Inpatient Sample (NIS) from the Healthcare Cost and Utilization Project of the Agency for Healthcare Research and Quality for the years 1988–2004 was queried for all hysterectomies for nonmalignant conditions. Data were analyzed based on the NIS sampling design. Bivariate analyses were used to examine the differences between women with and without VWD. Multivariate analysis was used to adjust for potential confounders among women who underwent hysterectomy for heavy menstrual bleeding. Results: 545 of the 1,358,133 hysterectomies were to women with VWD. Women with VWD were significantly more likely to experience intraoperative and postoperative bleeding (2.75% versus 0.89%, p < 0.001) and require transfusion (7.34% versus 2.13%, p < 0.001) than women without VWD. One woman with VWD died (odds ratio = 28.49). Conclusions: While the risk of bleeding complications from hysterectomy in women with VWD is smaller than previously reported, women with VWD did experience significantly more bleeding complications than women without VWD. Nonetheless, for women who have completed childbearing, the risks of hysterectomy may be acceptable.

Publication in peer-reviewed journals is the way to introduce new information that has clinical implications. However, clinicians may be reluctant to embark on the publication process because of lack of confidence or uncertainty about the process. The aim of this paper is to summarize the requirements of that process and to provide tips for successful publication to encourage potential clinical authors of manual therapy articles. In general, articles should contribute knowledge, corroborate or contradict previous knowledge, or summarize existing knowledge. Articles should be clearly structured, with abstract, introduction, methods, discussion, conclusion, and references; and often include tables and figures. The content of each of these sections is described. The use of standardized checklists is encouraged and the format should adhere to each journal's author guidelines. Submission is electronic and typically first the editor or deputy editor reviews for suitability, adherence to journal format, and quality of writing. If deemed suitable, the article is then sent out for blinded review by two reviewers with expertise in that area. Review typically takes 6-8 weeks, and all communication is via the editor. A decision is made then to either accept, accept with amendments to be made, reject but with advice to resubmit, or reject outright. In any re-submissions, the review teams' comments should be diligently addressed, either making the recommended changes or justifying why they have not been adopted. Common reasons for rejection of articles are given. Finally, the authors provide some tips for publication to help readers with successful submission of articles.

Purpose. To evaluate the effect of preoperative comorbidity status (defined by the Deyo index) on hospital mortality, postoperative complications, length of hospital stay, and hospital costs for shoulder arthroplasty patients. Methods. The overall mean hospital mortality and postoperative complication rates, and length of hospital stay and hospital costs stratified by the Deyo score were compared using the Pearson Chi squared test and the F-test, respectively. The effects of the Deyo score on hospital mortality and postoperative complications were estimated using multiple logistic regression. The length of hospital stay and hospital costs were estimated using multiple linear regression. The magnitude of the estimated effects of the Deyo score on the 4 outcomes were expressed as crude odds ratios (ORs) and adjusted ORs for age, race, gender, surgeon volume, and hospital volume. Results. Higher Deyo scores tended to be associated with higher hospital mortality, length of hospital stay, postoperative complications, and hospital costs. Compared with the referent group (Deyo score=0), patients with the highest Deyo scores (5–36) exhibited adjusted ORs of 11.8 for hospital mortality (p=0.011) and 1.1 for developing postoperative complications (p=0.098), and had the highest length of hospital stay (mean, 4.1 days) and hospital costs (mean, US$18 549). Conclusion. The Deyo score was a predictor of outcomes and costs in the shoulder arthroplasty population. By identifying relevant factors, health care providers can better determine who should be referred for shoulder arthroplasty and what should be considered when assessing risks and benefits.

The high frequency of static and dynamic palpation methods used during evaluation of SIJ problems in clinical practice demands an understanding of the factual quantity of movement at the SIJ. The objective of this systematic literature review was to synthesize three-dimensional (3-D) motion of the sacroiliac joint (SIJ) during various functional static postures and movements and to determine the clinical utility of movement during examination. A computer-based search was performed by means of OVID, which included Medline (February 1966 to April 2007) and CINAHL (February 1982 to April 2007) using the key words Pelvis, Kinematics, Imaging, Three-dimensional, and Stereophotogrammetric. Articles included in-vivo or in-vitro studies that investigated human SIJs with 3-D analysis. Three-dimensional analyses conducted using mathematical modeling, computerized modeling, and/or skin markers were not included because of concerns of transferability and validity. Studies that failed to report standard error of measurement (SEM) or defined tabulated values for translations or rotations using the Cartesian coordinate system were not considered for this study. Studies included for review were analyzed by the SBC biomechanical checklist to measure the quality of procedural design. Seven manuscripts were eligible for inclusion in this study. Rotation ranged between -1.1 to 2.2 degrees along the X-axis, -0.8 to 4.0 degrees along the Y-axis, and -0.5 to 8.0 degrees along the Z-axis. Translation ranged between -0.3 to 8.0 millimeters (mm) along the X-axis, -0.2 to 7.0 mm along the Y-axis, -0.3 to 6.0 mm along the Z-axis. Motion of the SIJ is limited to minute amounts of rotation and of translation suggesting that clinical methods utilizing palpation for diagnosing SIJ pathology may have limited clinical utility.

(2008). Excellence is a Moving Target. Journal of Manual & Manipulative Therapy: Vol. 16, No. 3, pp. 125-125.