Patient‐reported Outcome Measures in Emergency Care Research: A Primer for Researchers,Peer Reviewers,and Readers

Patient‐reported outcomes (PROs) are of increasing importance in clinical research because they capture patients’ experience with well‐being, illness, and their interactions with health care. Because PROs tend to focus on specific symptoms (e.g., pain, anxiety) or general assessments of patient functioning and quality of life that offer unique advantages compared to traditional clinical outcomes (e.g., mortality, emergency department revisits), emergency care researchers may benefit from incorporation of PRO measures into their research design as a primary or secondary outcome. Patients may also benefit from the ability of PROs to inform clinical practice and facilitate patient decision making, as PROs are obtained directly from the lived experience of other patients with similar conditions or health status. This review article introduces and defines key terminology relating to PROs, discusses reasons for utilizing PROs in clinical research, outlines basic psychometric and practical assessments that can be used to select a specific PRO measure, and highlights examples of commonly utilized PRO measures in emergency care research.     

Report of the NIH Task Force on Research Standards for Chronic Low Back Pain

Despite rapidly increasing intervention, functional disability due to chronic low back pain (cLBP) has increased in recent decades. We often cannot identify mechanisms to explain the major negative impact cLBP has on patients' lives. Such cLBP is often termed non-specific and may be due to multiple biologic and behavioral etiologies. Researchers use varied inclusion criteria, definitions, baseline assessments, and outcome measures, which impede comparisons and consensus. Therefore, NIH Pain Consortium charged a Research Task Force (RTF) to draft standards for research on cLBP. The resulting multidisciplinary panel recommended using 2 questions to define cLBP; classifying cLBP by its impact (defined by pain intensity, pain interference, and physical function); use of a minimum dataset to describe research participants (drawing heavily on the PROMIS methodology); reporting “responder analyses” in addition to mean outcome scores; and suggestions for future research and dissemination. The Pain Consortium has approved the recommendations, which investigators should incorporate into NIH grant proposals. The RTF believes that these recommendations will advance the field, help to resolve controversies, and facilitate future research addressing the genomic, neurologic, and other mechanistic substrates of chronic low back pain. We expect that the RTF recommendations will become a dynamic document and undergo continual improvement.PerspectiveA task force was convened by the NIH Pain Consortium with the goal of developing research standards for chronic low back pain. The results included recommendations for definitions, a minimum dataset, reporting outcomes, and future research. Greater consistency in reporting should facilitate comparisons among studies and the development of phenotypes.     

Effect of Massage on Clinical and Physiological Variables During Muscle Fatigue Task in Participants With Chronic Low Back Pain: A Crossover Study

ObjectiveThe purpose of this study was to determine if a reduction of short-term physiological and clinical effects of muscle fatigue can be seen after a session of massage in nonspecific chronic low back pain (cLBP) individuals and to study the possible association between physiological and clinical changes induced by massage.MethodsThirty-six cLBP individuals participated in 2 experimental sessions. In one session, the Sorenson protocol was preceded by a 30-minute massage, but in the other session, only the Sorenson test was performed by participants. Lumbar paraspinal muscle activity was recorded using surface electromyography, and maximal voluntary contraction force was measured using a load cell. Participants rated their lumbar pain intensity before and after massage and after the Sorensen protocol. A 2-way repeated-measures analysis of variance was conducted to test the effect of massage on both variables for both conditions. Pearson correlation analyses were conducted to determine the linear association between physiological and clinical responses to massage.ResultsResults showed that pain perception was significantly reduced after massage (P = .004) but did not seem to influence pain score increases occurring after the Sorensen protocol. Individuals with a high score of low back pain–related disability showed lower back muscle endurance time (r = -.35). Massage yielded no significant effect on fatigue-related physiological variables.ConclusionThe perception of pain in cLBP individuals was reduced after massage. Although massage yielded some positives clinical effects, they were not explained by a reduction in physiological effect of muscle fatigue.     

Patient Reported Outcomes and Unscheduled Health Services use During Oral Anti-Cancer Treatment

ContextPeople on oral anti-cancer agents must self-manage their symptoms with less interaction with oncology providers compared to infusion treatments. Symptoms and physical function are key patient-reported outcomes (PROs) and may lead to unscheduled health services uses (urgent care and emergency department [ED] visits, hospitalizations), which in turn lead to increased health care costs.ObjectivesTo evaluate the prediction of unscheduled health services uses using age, sex, and comorbidity, then determine the extent to which PRO data (symptoms and functioning) improve that prediction.MethodsThis post-hoc exploratory analysis was based on data from the control group of a trial of medication adherence reminder and symptom self-management intervention for people starting a new oral anti-cancer agent (n = 117 analyzed). Severity and interference with daily life for 18 symptoms, physical function, and depressive symptoms were assessed at intake (oral agent start), and four, eight, and 12 weeks later. Unscheduled health services use during three four-week periods after the start of oral agents was analyzed using generalized mixed effects models in relation to age, sex, comorbidity, and PROs at the beginning of each time period.ResultsThe summed severity index of 18 symptoms and physical function were significant predictors of hospitalizations in the four weeks following PRO assessment. The addition of PROs improved areas under the receiver operating characteristic curves to be over .70 in most time periods.ConclusionMonitoring of PROs has the potential of reducing unscheduled health services use if supportive care interventions are deployed based on their levels.     

Criteria for inclusion in programs of functional restoration for chronic low back pain: Pragmatic Study

BackgroundIndividuals with chronic low back pain (cLBP) may benefit from multimodal functional restoration programs (FRPs).ObjectiveThe aim of this study was to analyze characteristics of individuals with cLBP who were referred or not to an FRP. Because cLBP is a bio-psycho-social disorder, medical and social parameters were analysed.MethodsThis was an observational cross-sectional study performed in 2017 in 6 tertiary centres in France. Consecutive individuals with cLBP visiting a rheumatologist or physical medicine and rehabilitation physician were included. Individuals referred or not to an FRP were compared by demographic characteristics, duration of sick leave over the past year, self-reported physical activity > 1 h/week, pain (numeric rating scale 0–10), anxiety/depression (Hospital Anxiety and Depression Scale), disability (Oswestry Disability Index) and kinesiophobia (Tampa Kinesiophobia Scale). Univariate and multivariate logistic regression analyses were performed, estimating odds ratios (ORs) and 95% confidence intervals (CIs).ResultsWe included 147 individuals with cLBP. The mean (SD) age was 49 (12) years and 88 (60%) were women; 58 (38%) were referred to an FRP. On multivariate analysis, referral to an FRP was associated with reduced pain level (OR: 0.95, 95% CI: 0.91–0.99, for each 1-point increase in pain score), self-reported lack of physical activity (OR: 0.84, 95% CI: 0.72–0.98) and longer sick leave (OR: 1.03, 95% CI: 1.01–1.05, for 30 more days of sick leave).ConclusionIn this multicentric observational study, referral to an FRP was linked to pain, self-reported physical activity and sick leave but not medical characteristics assessed. These findings confirm the bio-psycho-social approach of FRPs for cLBP.     

Patient-reported improvements of pain,disability, and health-related quality of life following chiropractic care for back pain – A national observational study in Sweden

BackgroundChiropractic care is a common but not often investigated treatment option for back pain in Sweden. The aim of this study was to explore patient-reported outcomes (PRO) for patients with back pain seeking chiropractic care in Sweden.MethodsProspective observational study. Patients 18 years and older, with non-specific back pain of any duration, seeking care at 23 chiropractic clinics throughout Sweden were invited to answer PRO questionnaires at baseline with the main follow-up after four weeks targeting the following outcomes: Numerical Rating Scale for back pain intensity (NRS), Oswestry Disability Index for back pain disability (ODI), health-related quality of life (EQ-5D index) and a visual analogue scale for self-rated health (EQ VAS).Results246 back pain patients answered baseline questionnaires and 138 (56%) completed follow-up after four weeks. Statistically significant improvements over the four weeks were reported for all PRO by acute back pain patients (n = 81), mean change scores: NRS -2.98 (p < 0.001), ODI -13.58 (p < 0.001), EQ VAS 9.63 (p < 0.001), EQ-5D index 0.22 (p < 0.001); and for three out of four PRO for patients with chronic back pain (n = 57), mean change scores: NRS -0.90 (p = 0.002), ODI -2.88 (p = 0.010), EQ VAS 3.77 (p = 0.164), EQ-5D index 0.04 (p = 0.022).ConclusionsPatients with acute and chronic back pain reported statistically significant improvements in PRO four weeks after initiated chiropractic care. Albeit the observational study design limits causal inference, the relatively rapid improvements of PRO scores warrant further clinical investigations.     

Increased Salience Network Connectivity Following Manual Therapy is Associated with Reduced Pain in Chronic Low Back Pain Patients

Chronic low back pain (cLBP) has been associated with changes in brain plasticity. Nonpharmacological therapies such as Manual Therapy (MT) have shown promise for relieving cLBP. However, translational neuroimaging research is needed to understand potential central mechanisms supporting MT. We investigated the effect of MT on resting-state salience network (SLN) connectivity, and whether this was associated with changes in clinical pain. Fifteen cLBP patients, and 16 matched healthy controls (HC) were scanned with resting functional Magnetic Resonance Imaging (fMRI), before and immediately after a MT intervention (cross-over design with two separate visits, pseudorandomized, grades V ‘Manipulation’ and III ‘Mobilization’ of the Maitland Joint Mobilization Grading Scale). Patients rated clinical pain (0–100) pre- and post-therapy. SLN connectivity was assessed using dual regression probabilistic independent component analysis. Both manipulation (Pre: 39.43 ± 16.5, Post: 28.43 ± 16.5) and mobilization (Pre: 38.83 ± 17.7, Post: 31.76 ± 19.4) reduced clinical back pain (P < .05). Manipulation (but not mobilization) significantly increased SLN connectivity to thalamus and primary motor cortex. Additionally, a voxelwise regression indicated that greater MT-induced increase in SLN connectivity to the lateral prefrontal cortex was associated with greater clinical back pain reduction immediately after intervention, for both manipulation (r = -0.8) and mobilization (r = -0.54). Our results suggest that MT is successful in reducing clinical low back pain by both spinal manipulation and spinal mobilization. Furthermore, this reduction post-manipulation occurs via modulation of SLN connectivity to sensorimotor, affective, and cognitive processing regions.PerspectiveMT both reduces clinical low back pain and modulates brain activity important for the processing of pain. This modulation was shown by increased functional brain connectivity between the salience network and brain regions involved in cognitive, affective, and sensorimotor processing of pain.     

Effect of obesity and low back pain on spinal mobility: a cross sectional study in women

Background  

obesity is nowadays a pandemic condition. Obese subjects are commonly characterized by musculoskeletal disorders and particularly by non-specific chronic low back pain (cLBP). However, the relationship between obesity and cLBP remains to date unsupported by an objective measurement of the mechanical behaviour of the spine and its morphology in obese subjects. Such analysis may provide a deeper understanding of the relationships between function and the onset of clinical symptoms.     

Brain Mechanisms of Anticipated Painful Movements and Their Modulation by Manual Therapy in Chronic Low Back Pain

Heightened anticipation and fear of movement-related pain has been linked to detrimental fear-avoidance behavior in chronic low back pain (cLBP). Spinal manipulative therapy (SMT) has been proposed to work partly by exposing patients to nonharmful but forceful mobilization of the painful joint, thereby disrupting the relationship among pain anticipation, fear, and movement. Here, we investigated the brain processes underpinning pain anticipation and fear of movement in cLBP, and their modulation by SMT, using functional magnetic resonance imaging. Fifteen cLBP patients and 16 healthy control (HC) subjects were scanned while observing and rating video clips depicting back-straining or neutral physical exercises, which they knew they would have to perform at the end of the visit. This task was repeated after a single session of spinal manipulation (cLBP and HC group) or mobilization (cLBP group only), in separate visits. Compared with HC subjects, cLBP patients reported higher expected pain and fear of performing the observed exercises. These ratings, along with clinical pain, were reduced by SMT. Moreover, cLBP, relative to HC subjects, demonstrated higher blood oxygen level–dependent signal in brain circuitry that has previously been implicated in salience, social cognition, and mentalizing, while observing back straining compared with neutral exercises. The engagement of this circuitry was reduced after SMT, and especially the spinal manipulation session, proportionally to the magnitude of SMT-induced reduction in anticipated pain and fear. This study sheds light on the brain processing of anticipated pain and fear of back-straining movement in cLBP, and suggests that SMT may reduce cognitive and affective-motivational aspects of fear-avoidance behavior, along with corresponding brain processes.PerspectiveThis study of cLBP patients investigated how SMT affects clinical pain, expected pain, and fear of physical exercises. The results indicate that one of the mechanisms of SMT may be to reduce pain expectancy, fear of movement, and associated brain responses.     

Validity of the pain anxiety symptoms scale (PASS): prediction of physical capacity variables

Anxious responses to pain may lead to avoidance of behavior expected to produce pain. McCracken et al. (1992) developed the Pain Anxiety Symptoms Scale (PASS) to assess anxiety related specifically to pain. Efforts to validate the scale, however, have been confined mostly to examining associations between the PASS and other self-report instruments. This study tested whether PASS scores were related to behavioral performance variables recorded by therapists during a physical capacity evaluation. Participants were 98 male patients with persistent pain referred to two industrial rehabilitation centers. PASS scores were correlated negatively with amount of weight lifted and carried, and results of hierarchical regressions showed that PASS scores accounted for additional variance in these variables when measures of trait anxiety, depression and pain severity were controlled. However, we did not replicate the findings of McCracken et al. (1992) that PASS scores accounted for variance in self-reported disability with trait anxiety, depression or pain severity controlled. Results extend the validity of the PASS and are consistent with models of fear of pain: patients with high PASS scores may avoid potentially painful physical exertion to reduce their fear.     

The Pain Anxiety Symptoms Scale Fails to Discriminate Pain or Anxiety in a Chronic Disabling Occupational Musculoskeletal Disorder Population

Background: The Pain Anxiety Symptoms Scale (PASS) was developed to measure fear and anxiety responses to pain. Many studies have found associations between PASS scores and self‐report measures of pain, anxiety, and disability as well as among inhibited movement patterns and activity avoidance behaviors (eg, kinesophobia). This study aimed to identify clinically meaningful cut‐off points to identify high or low levels of pain anxiety and to determine if the PASS provides additional useful information in a functional restoration (FR) treatment program for chronic disabling occupational musculoskeletal disorder (CDOMD) patients. Methods: A consecutive cohort of 551 patients with CDOMD, who entered and completed a FR program, was administered a battery of psychosocial assessments, including the PASS, at admission and discharge. Socioeconomic outcomes were collected 1 year after discharge. After identifying clinical ranges for mild, moderate, and severe pain anxiety, the three groups were compared on self‐report measures of psychosocial distress, clinical diagnoses of psychosocial disorders, and 1‐year socioeconomic outcomes. Results: Correlations between the PASS and all measures of pain, anxiety, and disability were statistically significant. However, only the Pain Disability Questionnaire showed a large correlation coefficient (r > 0.5). Patients with the highest PASS scores were more likely to be diagnosed with a number of Axis I (depression, opioid dependence) or Axis II (Borderline Personality) psychiatric disorders. They were more likely to display treatment‐seeking behavior at 1 year after discharge. However, the PASS failed to differentiate between any other 1‐year outcomes. Conclusions: The PASS is elevated when other measures of psychosocial distress are also elevated. However, the PASS fails to discriminate between different indices of depression and anxiety and it is not highly related to 1‐year outcomes in a CDOMD cohort. If time and resources are limited, a different measure of psychosocial distress that does relate to socioeconomic outcomes might be a better option in a CDOMD evaluation process.     

Assessment of breast cancer disability: agreement between expert assessment and patient reports

Objective: To estimate the extent of agreement between health professionals’ (ClinRO) and patients’ (PRO) ratings on disabilities associated with breast cancer (impairments, activity limitations and participation restrictions). Design: Cross-sectional. Methods: Health care professionals measured arm impairments, activity limitations and participation restrictions with the international classification of functioning (ICF) breast cancer core set. Participants filled five outcomes measures targeting health aspects of QOL that were previously mapped to the ICF. Agreement between ClinRO and PRO was estimated with quadratic Kappa. Results: About 245 paired clinician and participant completed the outcomes measures. A total of 60 items mapped to 24 different ICF breast cancer core set codes, which provide 68 analyses for agreement. Impairment was better addressed with PROs (mostly poor and fair level of agreement); Activity limitations, both PROs and self-reported outcomes (SRO) (fair); participation restrictions, PROs (fair). Conclusion: Clinicians usually underestimate the symptoms and impairments of the patients, leading to a greater proportion of poor agreement. PRO’s provide valuable information on impairments at the mental function level and pain. ClinRO’s provide more valuable information on physically assessed impairments (oedema). Activity limitations and participation restrictions, excluding reporting the difficulty aspect of various life situations, can be either SRO or ObsRO.

• Implications for rehabilitation

• Impairments, activity limitation and participation restrictions are common sequelae of breast cancer treatment, which ultimately may affect the person’s quality of life and should be investigated early on in the continuum of care.

• Clinicians should rely on the symptoms’ reported by the patient regarding lymphedema and should identify the presence and severity of it.

• Patients inform best on the severity of pain, fatigue and mental distress experienced during and post-breast cancer treatment as clinicians tend to underestimate them.

• Clinicians and patients concur on presence and severity of activity limitations but not on difficulty, which can only be assessed from the patient’s perspective.

     

An evidence map of yoga for low back pain

ObjectiveYoga is being increasingly studied as a treatment strategy for a variety of different clinical conditions, including low back pain (LBP). We set out to conduct an evidence map of yoga for the treatment, prevention and recurrence of acute or chronic low back pain (cLBP).MethodsWe searched Medline, Cochrane Database of Systematic Reviews, EMBASE, Allied and Complementary Medicine Database and ClinicalTrials.gov for randomized controlled trials (RCT), systematic reviews or planned studies on the treatment or prevention of acute back pain or cLBP. Two independent reviewers screened papers for inclusion, extracted data and assessed the quality of included studies.ResultsThree eligible systematic reviews were identified that included 10 RCTs (n = 956) that evaluated yoga for non-specific cLBP. We did not identify additional RCTs beyond those included in the systematic reviews. Our search of ClinicalTrials.gov identified one small (n = 10) unpublished trial and one large (n = 320) planned clinical trial. The most recent good quality systematic review indicated significant effects for short- and long-term pain reduction (n = 6 trials; standardized mean difference [SMD] −0.48; 95% CI, −0.65 to −0.31; I² = 0% and n = 5; SMD −0.33; 95% CI, −0.59 to −0.07; I² = 48%, respectively). Long-term effects for back specific disability were also identified (n = 5; SMD −0.35; 95% CI, −0.55 to −0.15; I² = 20%). No studies were identified evaluating yoga for prevention or treatment of acute LBP.ConclusionEvidence suggests benefit of yoga in midlife adults with non-specific cLBP for short- and long-term pain and back-specific disability, but the effects of yoga for health-related quality of life, well- being and acute LBP are uncertain. Without additional studies, further systematic reviews are unlikely to be informative.     

Evaluating Auricular Point Acupressure for Chronic Low Back Pain Self-Management Using Technology: A Feasibility Study

BackgroundChronic low back pain, one of the most common reasons for seeking healthcare services, causes significant negative impacts on individuals and society. Nonpharmacologic therapies and self-management are included in practice guidelines, but their implementation is challenging.AimTo assess the feasibility of using an auricular point acupressure (APA) mobile app as a self-guided tool to learn and self-administer APA to manage chronic low back pain (cLBP) and to compare cLBP outcomes between 2 groups (app vs app + telehealth).DesignA 2-phase study design was used. In phase 1, participants (app group, n = 18) had in-person study visits and installed the app to learn and self-administer APA to manage cLBP. In phase 2, all research activities occurred remotely due to the COVID-19 pandemic, so a second group was recruited (app + telehealth, n = 19). The app + telehealth group underwent a virtual session, installed the app, and were provided the opportunity for questions and verification on the accuracy of the self-administered APA.SettingThe participants were recruited by distributing study flyers at outpatient clinics and referrals.ParticipantsParticipants with chronic low back pain were eliglbe for the study.MethodsUsing a quasi-experimental design with a mixed methods approach, all participants were instructed to download the APA app, provided an APA kit (includes seeds embedded within pre-cut squares of adhesive tape), and advised to self-administer APA with guidance from the app for 4 weeks to manage their cLBP. Study outcomes were collected at the preintervention time point as well as postintervention and 1-month follow-up. Interviews were also conducted at the postintervention time point.ResultsOf the 37 participants enrolled, six dropped out, and the attrition rate was 16%. Adherence to APA practice was high (85%-94%). After 4 weeks of APA treatment, participants in the app + telehealth group experienced a 29% decrease in pain intensity during the postintervention time point and a 35% reduction during the 1-month follow-up. Similar improvements were noted in pain interference (28%) and physical function (39%) for participants in the app + telehealth group at the 1-month follow-up. These changes are slightly higher compared with those in the app group (21% pain intensity reduction, 23% improved pain interferences, and 26% improved physical function) during the 1-month follow-up. Overall, APA was found to be feasible using the app and the qualitative findings showed acceptability of the intervention in both groups.ConclusionsIt is feasible to learn and self-administer APA with an app, supplemented with either in-person or telehealth sessions, presenting a promising intervention toward cLBP self-management. Telehealth was found to boost this intervention effectively.     

Comparison of the repercussions of cLBP in four French-speaking countries

IntroductionSociocultural factors may influence the impact of chronic low back pain (cLBP) on patients. The goal of this study was to compare pain and disability levels, and psychobehavioural parameters in four French-speaking countries in patients with cLBP.MethodsTwo hundred and seventy-eight patients were included: 83 in France, 36 in Morocco, 75 in the Ivory Coast and 84 in Tunisia. Demographic data were collected; pain was assessed using a visual analogue scale (VAS), disability with the Quebec scale, psychobehavioural factors by the hospital anxiety depression scale (HAD), the fear and avoidance beliefs questionnaire (FABQ) and the coping strategy questionnaire (CSQ). A Student t-test was used to compare means. Anova (covariance) was used to test for a “Country Effect”, i.e. the incidence of country on outcomes.OutcomesThere was no difference in disability levels between countries. A “country effect” was found (p < 0.001) for pain (F = 2.707), anxiety (F = 3.467), depression (F = 5.137), fear and avoidance beliefs regarding professional activity (F = 1.974) and physical activity (F = 5.076), strategy of distraction, dramatization, efforts to ignore pain, prayer, seeking social support and reinterpretation (p < 0.01). Pain level was higher in Morocco (p < 0.05); anxiety, depression, fear and avoidance beliefs about physical activities were higher in Tunisia (p < 0.05) and fear and avoidance beliefs about professional activities were higher in the Ivory Coast (p < 0.01). Among the coping strategies used, distraction, dramatization, prayer and search for social support were used more in the Ivory Coast; reinterpretation in Tunisia; seeking social support was less common in France.ConclusionIn this population of patients with cLBP, despite similar disability levels across the four French-speaking countries, there were considerable variations in pain level and psychobehavioural repercussions.     

Osteopathic manipulative treatment in obese patients with chronic low back pain: A pilot study

BackgroundObesity is frequently associated with various musculoskeletal disorders including chronic low back pain (cLBP). Osteopathy is a discipline emphasizing the conservative treatment of the disease in an olistic vision. We designed a randomized controlled study to investigate whether Osteopathic Manipulative Treatment (OMT) combined with specific exercises (SE) is more effective than SE alone in obese patients with cLBP.Methodsnineteen obese females with cLBP, randomized into 2 groups: SE + OMT and SE were studied during the forward flexion of the spine using an optoelectronic system. A biomechanical model was developed in order to analyse kinematics and define angles of clinical interest.Outcome measureskinematic of the thoracic and lumbar spine and pelvis during forward flexion, pain according to a visual analogue scale (VAS), Roland Morris Disability Questionnaire and Oswestry Low Back Pain Disability Questionnaire.Resultssignificant effects on kinematics were reported only for OMT + SE with an improvement in thoracic range of motion of nearly 20%. All scores of the clinical scales used improved significantly. The greatest improvements occurred in the OMT + SE group.Conclusionscombined rehabilitation treatment including Osteopathic Manipulative Treatment (OMT + SE) showed to be effective in improving biomechanical parameters of the thoracic spine in obese patients with cLBP. Such results are to be attributed to OMT, since they were not evident in the SE group. We also observed a reduction of disability and pain. The clinical results should be considered preliminary due to the small sample size.     

Long-Term Medicare Costs Associated With Opioid Analgesic Therapy vs Spinal Manipulative Therapy for Chronic Low Back Pain in a Cohort of Older Adults

ObjectivesThe purpose of this study was to compare Medicare healthcare expenditures for patients who received long-term treatment of chronic low back pain (cLBP) with either opioid analgesic therapy (OAT) or spinal manipulative therapy (SMT).MethodsWe conducted a retrospective observational study using a cohort design for analysis of Medicare claims data. The study population included Medicare beneficiaries enrolled under Medicare Parts A, B, and D from 2012 through 2016. We assembled cohorts of patients who received long-term management of cLBP with OAT or SMT (such as delivered by chiropractic or osteopathic practitioners) and evaluated the comparative effect of OAT vs SMT upon expenditures, using multivariable regression to control for beneficiary characteristics and measures of health status, and propensity score weighting and binning to account for selection bias.ResultsThe study sample totaled 28,160 participants, of whom 77% initiated long-term care of cLBP with OAT, and 23% initiated care with SMT. For care of low back pain specifically, average long-term costs for patients who initiated care with OAT were 58% lower than those who initiated care with SMT. However, overall long-term healthcare expenditures under Medicare were 1.87 times higher for patients who initiated care via OAT compared with those initiated care with SMT (95% CI 1.65-2.11; P < .0001).ConclusionsAdults aged 65 to 84 who initiated long-term treatment for cLBP via OAT incurred lower long-term costs for low back pain but higher long-term total healthcare costs under Medicare compared with patients who initiated long-term treatment with SMT.     

The use of patient-reported outcomes instruments in registered clinical trials: Evidence from ClinicalTrials.gov

BackgroundInvestigators of clinical trials in which the list of outcomes include patient-reported outcomes (PROs) – usually labeled quality of life (QoL) – have a large number of instruments from which to choose. The extent and manner in which PRO instruments are used in clinical trials can be assessed using data from clinical trial registries. Most medical journals now require a clinical trial be registered before its results are considered for publication. This requirement is intended to discourage publication bias, such as the reporting of tests of hypotheses different from those stipulated at the start of the trial and selective reporting of partial results.PurposeTo assess the usage of PRO instruments in registered trials by various trial characteristics and to determine if the instruments are adequately identified in the registry.MethodsA local copy of the ClinicalTrials.gov database was made in September 2007. The outcomes of all interventional trials registered since September 2004 were assessed for usage of a PRO instrument. Odds ratios of PRO usage were estimated by a logistic regression model.ResultsOf 17,704 interventional trials, 2481 (14.0%) used at least one PRO instrument. However, less than half of those trials (41.0%) identified the instrument to be used. PRO usage is positively associated with phase (III), randomization type (randomized), intervention type (behavior) and sponsorship type (university/research organization).ConclusionsPRO instruments are used in a significant percentage but minority of clinical trials. Trial registries should require that all PRO instruments be identified, including the concepts or outcomes they are intended to measure.     

“Feeling better” or “feeling well” in usual care of hip and knee osteoarthritis pain: Determination of cutoff points for patient acceptable symptom state (PASS) and minimal clinically important improvement (MCII) at rest and on movement in a national multicenter cohort study of 2414 patients with painful osteoarthritis

Patient-reported outcome measures are being developed for more relevant assessments of pain management. The patient acceptable symptom state (PASS) (“feeling well”) and the minimal clinically important improvement (MCII) (“feeling better”) have been determined in clinical trials, but not in daily pain management. We carried out a national multicenter cohort study of patients over the age of 50 years with painful knee osteoarthritis (KOA) or hip osteoarthritis (HOA) who had visited their general practitioner and required treatment for more than 7 days. Overall, 2414 patients (50.2% men, mean age 67.3 years, body mass index 27.9 kg/m², 33.5% with HOA) were enrolled by 1116 general practitioners. After 7 days of treatment, PASS was estimated on a numerical rating scale as 4 at rest and 5 on movement, for both HOA and KOA, above the PASS threshold in clinical trials. In KOA, PASS was more frequently reached in men and younger people with less pain at rest and on movement, and in patients specifically seeking an improvement during sport activities. In HOA, PASS was most frequently reached in patients with low levels of pain at risk and in nonobese patients. MCII was −1 numerical rating scale point after 7 days of usual treatment. This improvement is smaller than that recorded in randomized controlled trials, and was the same for both sites, both at rest and on movement. In conclusion, patient-reported outcome values in daily practice differ from those in clinical trials, and their determinant factors may depend on the site of osteoarthritis. Assessments of the treatment of painful osteoarthritis should be adapted to the characteristics and daily life of the patient, to personalize patient management.