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INTRODUCTION: Understanding individual patient preferences for chronic low back pain (cLBP) outcomes is essential for targeting available therapeutic options; yet tools to elicit patient outcome preferences are limited. OBJECTIVE: To develop and test a choice-based conjoint (CBC) measure, commonly used in behavioral economics research, to elicit what outcomes patients with cLBP want to achieve and avoid. DESIGN: We developed a survey-based CBC measure to allow patients to make risk/benefit trade-off choices between possible treatment outcomes. After extensive literature, clinician, and patient input, our measure included seven attributes: fatigue, anxiety/depression, difficulty thinking/making decisions, pain intensity, physical abilities, change in pain, and ability to enjoy life despite pain. Random-parameters logit models were used to estimate strength of preferences, and latent class analysis was used to identify patient characteristics associated with distinct preference. SETTING: Online study using the Sawtooth web-based platform. PARTICIPANTS: Two hundred eleven individuals with cLBP recruited from online advertising as well as at clinical sites across multiple academic and private institutions. INTERVENTIONS: Not applicable. RESULTS: The most valued outcome was the highest level of physical activity (ß = 1.6-1.98; p < .001), followed by avoiding cognitive difficulties (ß = -1.48; p < .001). Avoidance of severe pain was comparable to avoiding constant fatigue and near-constant depression/anxiety (ß = -0.99, -1.02); p < .001). There was an association between preferences and current pain/disability status; patients with higher pain had a stronger preference to avoid severe pain, whereas those with higher disability have stronger preferences for achieving physical activity. The latent class analysis identified two distinct groups: (1) more risk-seeking and willing to accept worse outcomes (56%); and (2) more risk-averse with a stronger preference for achieving maximum benefits (44%). CONCLUSIONS: Our study illuminated cLBP patient preferences for treatment outcomes and heterogeneity in these preferences. Patients stressed the importance of reaching high physical activity and avoiding cognitive declines, even over a desire to avoid pain. More work is needed to understand patient preferences to aid informed, shared decisions.
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BACKGROUND: The Healing Encounters and Attitudes Lists (HEALs) patient-reported measures, consisting of 6 separate context factor questionnaires, predict patients' pain improvements. Our Patient-centered Outcomes Research Initiative-funded implementation project demonstrated success in using HEAL data during clinic consultations to enhance patient engagement, improve patient outcomes, and reduce opioid prescribing. OBJECTIVE: We aimed to determine the resources needed for additional sites to implement HEAL to improve pain care treatment. RESEARCH DESIGN: An observational study from March 1 to November 30, 2021, assessing implementation cost data from invoices, time and salary requirements for clinic personnel training, estimates of non-site-based costs, and one-time resource development costs. SUBJECTS: Unique patients eligible to complete a HEAL survey (N=24,018) and 74 clinic personnel. MEASURES: The Stages of Implementation Completion guided documentation of preimplementation, implementation, and sustainment activities of HEAL pain clinic operations. These informed the calculations of the costs of implementation. RESULTS: The total time for HEAL implementation is 7 months: preimplementation and implementation phases (4 mo) and sustainment (3 mo). One hour of HEAL implementation involving a future clinical site consisting of 2 attending physicians, 1 midlevel provider, 1 nurse manager, 1 nurse, 1 radiology technician, 2 medical assistants, and 1 front desk staff will cost $572. A 10-minute time increment for all clinic staff is $95. Total implementation costs based on hourly rates over 7 months, including non-site-based costs of consultations, materials, and technology development costs, is $28,287. CONCLUSIONS: Documenting our implementation costs clarifies the resources needed for additional new sites to implement HEAL to measure pain care quality and to engage patients and clinic personnel.
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Analgésicos Opioides , Clínicas de Dolor , Humanos , Pautas de la Práctica en Medicina , Medición de Resultados Informados por el Paciente , Dolor , ElectrónicaRESUMEN
OBJECTIVE: Aging is associated with increased pro-inflammatory gene expression and systemic inflammation, and psychosocial stress may accelerate these changes. Mindfulness interventions show promise for reducing psychosocial stress and extending healthspan. Inflammatory pathways may play a role. In a sample of lonely older adults, we tested whether mindfulness training reduces proinflammatory gene expression and protein markers of systemic inflammation. METHODS: Lonely older adults (65-85 years; N = 190) were randomly assigned to an 8-week Mindfulness-Based Stress Reduction (MBSR) or matched Health Enhancement Program (HEP). Blood was drawn pre- and post-intervention and at 3-month follow-up. In peripheral blood mononuclear cells (PBMCs), RNA profiling was used to assess transcriptional regulation by pro-inflammatory NF-kB as well as ß-adrenergic CREB, antiviral IRF, and glucocorticoid receptor (GR) transcription factors. Plasma was assayed for proinflammatory markers IL-6 and CRP. Analyses tested time (pre, post, follow-up) by condition (MBSR versus HEP) effects. RESULTS: MBSR reduced NF-kB (d = .17, p = .028) but did not alter CREB (d = .10, p = .20), IRF (d = .13, p = .086), or GR activity (d = .14, p = .063) relative to HEP over time. Contrary to predictions, there were no time × condition effects of MBSR compared to HEP on reducing circulating IL-6 or CRP. CONCLUSIONS: In lonely older adults, MBSR reduced cellular pro-inflammatory gene regulation in ways that would predict reduced disease risk. However, no similar effect was observed for circulating protein markers of inflammation. These results provide specificity about how mindfulness interventions may impact distinct inflammatory markers among aging adults in ways that may have important implications for healthspan. TRIAL REGISTRATION: Clinical Trials identifier NCT02888600.
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Background: Mindfulness research and clinical programs are widespread, and it is important that mindfulness-based interventions are delivered with fidelity, or as intended, across settings. The MBI:TAC is a comprehensive system for assessing teacher competence, yet it can be complex to implement. A standardized, simple fidelity/engagement tool to address treatment delivery is needed. Objective: We describe the development, evaluation, and outcomes of a brief, practical tool for assessing fidelity and engagement in online mindfulness-based programs. The tool contains questions about session elements such as meditation guidance and group discussion, and questions about participant engagement and technology-based barriers to engagement. Methods: The fidelity rating tool was developed and tested in OPTIMUM, Optimizing Pain Treatment in Medical settings Using Mindfulness. The OPTIMUM study is a 3-site pragmatic randomized trial of group medical visits and adapted mindfulness-based stress reduction for primary care patients with chronic low back pain, delivered online. Two trained study personnel independently rated 26 recorded OPTIMUM sessions to determine inter-rater reliability of the Concise Fidelity for Mindfulness-Based Interventions (CoFi-MBI) tool. Trained raters also completed the CoFi-MBI for 105 sessions. Raters provided qualitative data via optional open text fields within the tool. Results: Inter-rater agreement was 77-100% for presence of key session components, and 69-88% for Likert ratings of participant engagement and challenges related to technology, with discrepancies only occurring within 2 categories: 'very much' and 'quite a bit'. Key session components occurred as intended in 94-100% of the 105 sessions, and participant engagement was rated as 'very much' or 'quite a bit' in 95% of the sessions. Qualitative analysis of rater comments revealed themes related to engagement challenges and technology failures. Conclusion: The CoFi-MBI provides a practical way to assess basic adherence to online delivery of mindfulness session elements, participant engagement, and extent of technology obstacles. Optional text can guide strategies to improve engagement and reduce technology barriers.
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Psychologically informed practice (PiP) includes a special focus on psychosocial obstacles to recovery, but research trials have revealed significant difficulties in implementing PiP outside of research environments. Qualitative studies have identified problems of both competence and confidence in tackling the psychosocial aspects of care, with a tendency to prefer dealing with the more mechanical aspects of care. In PiP, the distinction between assessment and management is not clear-cut. Analysis of the problem is part of the intervention, and guided self-management begins with the initial detective work by the patient, who is encouraged to develop successful and relevant behavior change. This requires a different style and focus of communication that some clinicians find difficult to enact. In this Perspective, the PiP Consultation Roadmap is offered as a guide for clinical implementation to establish a therapeutic relationship, develop patient-centered communication, and guide effective pain self-management. These strategies are illustrated through the metaphor of the patient learning to drive, with the therapist as a driving instructor and the patient as a student driver. For convenience, the Roadmap is depicted in 7 stages. Each stage represents aspects of the clinical consultation in a recommended order, although the Roadmap should be viewed as a general guide with a degree of flexibility to accommodate individual differences and optimize PiP interventions. It is anticipated that the experienced PiP clinician will find it progressively easier to implement the Roadmap as the building blocks and style of consultation become more familiar.
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Comunicación , Estudiantes , Humanos , Manejo del DolorRESUMEN
Quality of life (QOL) and life satisfaction are important research priorities for autistic adults. As such, we saw a need to evaluate individual items of commonly used subjective QOL scales to understand how they are interpreted and perceived by autistic adults. This study used cognitive interviews and repeated sampling to evaluate the accessibility, test-retest reliability and internal consistency of several common QOL measures in a sample of young autistic adults (n = 20; aged 19-32). Cognitive interviews suggested that the Satisfaction with Life Scale was well understood and demonstrated excellent internal consistency and test-retest reliability. While the WHOQoL-BREF and WHOQoL Disability Modules had adequate reliability, cognitive interviews suggested that additional instructions and examples would further enhance their accessibility for use with autistic adults.
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There has been increasing interest in the secondary prevention of chronic pain and pain-associated disability over the past 3 decades. In 2011, psychologically informed practice (PiP) was suggested as a framework for managing persistent and recurrent pain, and, since then, it has underpinned the development of stratified care linking risk identification (screening). Although PiP research trials have demonstrated clinical and economic advantage over usual care, pragmatic studies have been less successful, and qualitative studies have identified implementation difficulties in both system delivery and individual clinical management. Effort has been put into the development of screening tools, the development of training, and the assessment of outcomes; however, the nature of the consultation has remained relatively unexplored. In this Perspective, a review of the nature of clinical consultations and the clinician-patient relationship is followed by reflections on the nature of communication and the outcome of training courses. Consideration is given to the optimization of communication, including the use of standardized patient-reported measures and the role of the therapist in facilitating adaptive behavior change. Several challenges in implementing a PiP approach in day-to-day practice are then considered. Following brief consideration of the impact of recent developments in health care, the Perspective concludes with a brief introduction to the PiP Consultation Roadmap (the subject of a companion paper), the use of which is suggested as a way of structuring the consultation with the flexibility required for a patient-centered approach to guided self-management of chronic pain conditions.
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Dolor Crónico , Humanos , Dolor Crónico/terapia , Comunicación , Atención a la SaludRESUMEN
OBJECTIVE: We developed and used a discrete-choice measure to study patient preferences with regard to the risks and benefits of nonsurgical treatments when they are making treatment selections for chronic low back pain. METHODS: "CAPER TREATMENT" (Leslie Wilson) was developed with standard choice-based conjoint procedures (discrete-choice methodology that mimics an individual's decision-making process). After expert input and pilot testing, our final measure had 7 attributes (chance of pain relief, duration of relief, physical activity changes, treatment method, treatment type, treatment time burden, and risks of treatment) with 3-4 levels each. Using Sawtooth software (Sawtooth Software, Inc., Provo, UT, USA), we created a random, full-profile, balanced-overlap experimental design. Respondents (n = 211) were recruited via an emailed online link and completed 14 choice-based conjoint choice pairs; 2 fixed questions; and demographic, clinical, and quality-of-life questions. Analysis was performed with random-parameters multinomial logit with 1000 Halton draws. RESULTS: Patients cared most about the chance of pain relief, followed closely by improving physical activity, even more than duration of pain relief. There was comparatively less concern about time commitment and risks. Gender and socioeconomic status influenced preferences, especially with relation to strength of expectations for outcomes. Patients experiencing a low level of pain (Pain, Enjoyment, and General Activity Scale [PEG], question 1, numeric rating scale score<4) had a stronger desire for maximally improved physical activity, whereas those in a high level of pain (PEG, question 1, numeric rating scale score>6) preferred both maximum and more limited activity. Highly disabled patients (Oswestry Disability Index score>40) demonstrated distinctly different preferences, placing more weight on achieving pain control and less on improving physical activity. CONCLUSIONS: Individuals with chronic low back pain were willing to trade risks and inconveniences for better pain control and physical activity. Additionally, different preference phenotypes exist, which suggests a need for clinicians to target treatments to particular patients.
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Dolor de la Región Lumbar , Humanos , Dolor de la Región Lumbar/terapia , Conducta de Elección , Prioridad del Paciente , Manejo del DolorRESUMEN
OBJECTIVE: One aim of the Back Pain Consortium (BACPAC) Research Program is to develop an integrated model of chronic low back pain that is informed by combined data from translational research and clinical trials. We describe efforts to maximize data harmonization and accessibility to facilitate Consortium-wide analyses. METHODS: Consortium-wide working groups established harmonized data elements to be collected in all studies and developed standards for tabular and nontabular data (eg, imaging and omics). The BACPAC Data Portal was developed to facilitate research collaboration across the Consortium. RESULTS: Clinical experts developed the BACPAC Minimum Dataset with required domains and outcome measures to be collected by use of questionnaires across projects. Other nonrequired domain-specific measures are collected by multiple studies. To optimize cross-study analyses, a modified data standard was developed on the basis of the Clinical Data Interchange Standards Consortium Study Data Tabulation Model to harmonize data structures and facilitate integration of baseline characteristics, participant-reported outcomes, chronic low back pain treatments, clinical exam, functional performance, psychosocial characteristics, quantitative sensory testing, imaging, and biomechanical data. Standards to accommodate the unique features of chronic low back pain data were adopted. Research units submit standardized study data to the BACPAC Data Portal, developed as a secure cloud-based central data repository and computing infrastructure for researchers to access and conduct analyses on data collected by or acquired for BACPAC. CONCLUSIONS: BACPAC harmonization efforts and data standards serve as an innovative model for data integration that could be used as a framework for other consortia with multiple, decentralized research programs.
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Dolor de la Región Lumbar , Humanos , Dolor de la Región Lumbar/terapia , Evaluación de Resultado en la Atención de Salud , Proyectos de InvestigaciónRESUMEN
OBJECTIVES: Awareness (being present), acceptance, and engagement (committed action) are three dimensions of psychological flexibility. Understanding these in the context of chronic pain may identify treatment targets to help refine individual treatment. Our objective was to test the predictive capacity of three dimensions within the psychological flexibility model on the longitudinal trajectory of pain interference. METHODS: Patients receiving pain psychology treatment at a pain management center participated in this pragmatic clinical longitudinal study (n=86 with at least three assessments; Mean age=51 years; Gender=60 females, 26 males). Measures included the Five Facet Mindfulness Questionnaire (FFMQ-SF); Chronic Pain Acceptance Questionnaire (CPAQ-8); Psychological Inflexibility in Pain Scale (PIPS-12); and Committed Action Questionnaire (CAQ-8). The dependent variable was the Patient Reported Outcomes Information System (PROMIS) Pain Interference (PI). We used latent growth modelling to analyze scores assessed within 180 days of patient care. RESULTS: Psychological inflexibility (PIPS-12) and pain acceptance (CPAQ-8) measured at baseline predicted PI outcomes (n=86). PIPS-12 showed a direct relationship with pain interference (PI), where higher PIPS-12 scores predicted significantly higher PI mean scores on average across the study period (ρ=0.422, r2=0.382) but also predicted significantly greater decreases in PI across time (ρ=-0.489, r2=0.123). Higher CPAQ-8 scores predicted significantly lower PI mean scores on average across the study period (ρ=-0.478, r2=0.453) but also significantly smaller decreases in PI across time (ρ=0.495, r2=0.076). Awareness (FFMQ-SF) and engagement (CAQ-8) were not predictive of PI outcomes. CONCLUSIONS: Patients who entered pain psychology treatment with lower pain acceptance and higher psychological inflexibility showed the largest reductions in pain interference across time. These results contribute towards a novel prognostic understanding of the predictive roles of an enhancing dimension and limiting dimension of psychological flexibility.
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Dolor Crónico , Atención Plena , Masculino , Femenino , Humanos , Persona de Mediana Edad , Dolor Crónico/terapia , Dolor Crónico/psicología , Adaptación Psicológica , Estudios Longitudinales , Manejo del DolorRESUMEN
As a member of the Back Pain Consortium (BACPAC), the University of Pittsburgh Mechanistic Research Center's research goal is to phenotype chronic low back pain using biological, biomechanical, and behavioral domains using a prospective, observational cohort study. Data will be collected from 1,000 participants with chronic low back pain according to BACPAC-wide harmonized and study-specific protocols. Participation lasts 12 months with one required in person baseline visit, an optional second in person visit for advanced biomechanical assessment, and electronic follow ups at months 1, 2, 3, 4, 5, 6, 9, and 12 to assess low back pain status and response to prescribed treatments. Behavioral data analysis includes a battery of patient-reported outcomes, social determinants of health, quantitative sensory testing, and physical activity. Biological data analysis includes omics generated from blood, saliva, and spine tissue. Biomechanical data analysis includes a physical examination, lumbopelvic kinematics, and intervertebral kinematics. The statistical analysis includes traditional unsupervised machine learning approaches to categorize participants into groups and determine the variables that differentiate patients. Additional analysis includes the creation of a series of decision rules based on baseline measures and treatment pathways as inputs to predict clinical outcomes. The characteristics identified will contribute to future studies to assist clinicians in designing a personalized, optimal treatment approach for each patient.
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Dolor de la Región Lumbar , Humanos , Dolor de la Región Lumbar/diagnóstico , Dolor de la Región Lumbar/terapia , Estudios de Cohortes , Estudios Prospectivos , Dolor de Espalda , Fenotipo , Estudios Observacionales como AsuntoRESUMEN
The Biobehavioral Working Group of BACPAC was charged to evaluate a range of psychosocial, psychophysical, and behavioral domains relevant to chronic low back pain, and recommend specific assessment tools and procedures to harmonize biobehavioral data collection across the consortium. Primary references and sources for measure selection were the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials, the Minimum Data Set from the National Institutes of Health (NIH) Research Task Force on Standards for Chronic Low Back Pain, the Patient-Reported Outcomes Measurement Information System, and NeuroQOL. The questionnaire's recommendations supplemented the NIH HEAL Common Data Elements and BACPAC Minimum Data Set. Five domains were identified for inclusion: Pain Characteristics and Qualities; Pain-Related Psychosocial/Behavioral Factors; General Psychosocial Factors; Lifestyle Choices; and Social Determinants of Health/Social Factors. The Working Group identified best practices for required and optional Quantitative Sensory Testing of psychophysical pain processing for use in BACPAC projects.
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Dolor de la Región Lumbar , Proyectos de Investigación , Estados Unidos , Humanos , Comités Consultivos , Dimensión del Dolor/métodos , National Institutes of Health (U.S.)RESUMEN
Loneliness is a potent psychosocial stressor that predicts poor health and mortality among older adults, possibly in part by accelerating age-related declines in immunocompetence. Mindfulness interventions have shown promise for reducing loneliness and improving markers of physical health. In a sample of lonely older adults, this two-arm parallel trial tested whether mindfulness training enhances stimulated interleukin-6 (IL-6) production, a measure of innate immune responsivity. Lonely older adults (65-85 years; N = 190) were randomized to an 8-week Mindfulness-Based Stress Reduction (MBSR) or control Health Enhancement Program (HEP) intervention. Lipopolysaccharide (LPS)-stimulated production of IL-6 was measured in vitro by blinded outcome assessors at pre-intervention, post-intervention, and 3-month follow-up. Mixed-effects linear models tested time (pre, post, follow-up) by condition (MBSR vs. HEP) effects. As predicted, a significant time × condition effect on stimulated IL-6 production was observed across pre, post, and follow-up timepoints. Significant MBSR vs. HEP differences emerged from pre- to post-intervention (p =.009, d = 0.38) and from pre-intervention to 3-month follow-up (p =.017, d = 0.35), with larger increases in IL-6 production following MBSR compared to HEP. No study-related adverse events were reported. Results show that mindfulness training may be effective for boosting innate immunocompetence among lonely older adults. Given that immunocompetence tends to decline with age, mindfulness training may help to counteract the effects of aging and psychosocial stress on infection risk and recovery from injury.
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Atención Plena , Expresión Génica , Interleucina-6 , Soledad , Atención Plena/métodos , Estrés Psicológico/terapia , Estrés Psicológico/psicología , Resultado del Tratamiento , Humanos , Anciano , Anciano de 80 o más AñosRESUMEN
Mindfulness meditation has become a successful treatment of both physical and psychosocial ailments over the past decade. Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT) are now implemented in various clinical and hospital settings for the treatment of stress, depression, substance abuse, and chronic pain. However, given mindfulness meditation's exponential rise in popularity, scientific and media reports have called for the evaluation of mindfulness meditation's safety for those who participate in its programs. Studies have described adverse events, such as anxiety and pain, and more severe events like psychosis, that have been associated with mindfulness meditation. However, there has not been a consistent, systematic way to define and report adverse events in meditation randomized control trials. The objective of our viewpoint was to dispel the notion that these emotive feelings and sensations are adverse events due to mindfulness meditation. Instead, they are actually expected reactions involved in the process of achieving the true benefits of mindfulness meditation. For the more severe outcomes of meditation, for example, psychosis and mania, these events are confounded by other factors, such as the intensity and length of the meditative practices as well as psychological stressors and the psychiatric histories of those affected. Comparatively, mindfulness-based programs like MBSR and MBCT are shorter in duration and less intense. They are designed to be adapted to their participants' needs as to not induce pain or panic. Mindfulness meditation teaches its students to learn how to deal with their minds and bodies instead of using maladaptive coping techniques. Thus, we urge that further research in mindfulness meditation consistently use the definition of adverse events as those which lead to severe outcomes or hospitalization.
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Introduction: Meditation has been shown to enhance a user's ability to control a sensorimotor rhythm (SMR)-based brain-computer interface (BCI). For example, prior work have demonstrated that long-term meditation practices and an 8-week mindfulness-based stress reduction (MBSR) training have positive behavioral and neurophysiological effects on SMR-based BCI. However, the effects of short-term meditation practice on SMR-based BCI control are still unknown. Methods: In this study, we investigated the immediate effects of a short, 20-minute meditation on SMR-based BCI control. Thirty-seven subjects performed several runs of one-dimensional cursor control tasks before and after two types of 20-minute interventions: a guided mindfulness meditation exercise and a recording of a narrator reading a journal article. Results: We found that there is no significant change in BCI performance and Electroencephalography (EEG) BCI control signal following either 20-minute intervention. Moreover, the change in BCI performance between the meditation group and the control group was found to be not significant. Discussion: The present results suggest that a longer period of meditation is needed to improve SMR-based BCI control.
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Mindfulness-based stress reduction (MBSR) is an evidence-based non-pharmacological approach for chronic low back pain (cLBP), yet it is not readily available or reimbursable within primary care clinics. Primary care providers (PCPs) who wish to avoid prescribing opioids and other medications typically have few options for their cLBP patients. We present the protocol of a pragmatic clinical trial entitled OPTIMUM (Optimizing Pain Treatment In Medical settings Using Mindfulness). OPTIMUM is offered online via telehealth and includes medical group visits (MGV) with a PCP and a mindfulness meditation intervention modeled on MBSR for persons with cLBP. In diverse health-care settings in the US, such as a safety net hospital, federally qualified health centers, and a large academic health system, 450 patients will be assigned randomly to the MGV + MBSR or to usual PCP care alone. Participants will complete self-report surveys at baseline, following the 8-week program, and at 6- and 12-month follow-up. Health care utilization data will be obtained through electronic health records and via brief monthly surveys completed by participants. The primary outcome measure is the PEG (Pain, enjoyment, and general activity) at the 6-month follow-up. Additionally, we will assess psychological function, healthcare resource use, and opioid prescriptions. This trial, which is part of the NIH HEAL Initiative, has the potential to enhance primary care treatment of cLBP by combining PCP visits with a non-pharmacological treatment modeled on MBSR. Because it is offered online and integrated into primary care, it is expected to be scalable and accessible to underserved patients. Clinical Trials.gov: NCT04129450.
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Dolor Crónico , Dolor de la Región Lumbar , Meditación , Atención Plena , Telemedicina , Analgésicos Opioides , Dolor Crónico/terapia , Humanos , Dolor de la Región Lumbar/terapia , Estrés Psicológico , Resultado del TratamientoRESUMEN
BACKGROUND: Many patients with acute low back pain (LBP) first seek care from primary care physicians. Evidence is lacking for interventions to prevent transition to chronic LBP in this setting. We aimed to test if implementation of a risk-stratified approach to care would result in lower rates of chronic LBP and improved self-reported disability. METHODS: We conducted a pragmatic, cluster randomized trial using 77 primary care clinics in four health care systems across the United States. Practices were randomly assigned to a stratified approach to care (intervention) or usual care (control). Using the STarTBack screening tool, adults with acute LBP were screened low, medium, and high-risk. Patients screened as high-risk were eligible. The intervention included electronic best practice alerts triggering referrals for psychologically informed physical therapy (PIPT). PIPT education was targeted to community clinics geographically close to intervention primary care clinics. Primary outcomes were transition to chronic LBP and self-reported disability at six months. Trial Registry: ClinicalTrials.gov NCT02647658. FINDINGS: Between May 2016 and June 2018, 1207 patients from 38 intervention and 1093 from 37 control practices were followed. In the intervention arm, around 50% of patients were referred for physical therapy (36% for PIPT) compared to 30% in the control. At 6 months, 47% of patients reported transition to chronic LBP in the intervention arm (38 practices, n = 658) versus 51% of patients in the control arm (35 practices, n = 635; OR=0.83 95% CI 0.64, 1.09; p = 0.18). No differences in disability were detected (difference -2·1, 95% CI -4.9-0.6; p = 0.12). Opioids and imaging were prescribed in 22%-25% and 23%-26% of initial visits, for intervention and control, respectively. Twelve-month LBP utilization was similar in the two groups. INTERPRETATION: There were no differences detected in transition to chronic LBP among patients presenting with acute LBP using a stratified approach to care. Opioid and imaging prescribing rates were non-concordant with clinical guidelines. FUNDING: Patient-Centered Outcomes Research Institute (PCORI) contract # PCS-1402-10867.
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OBJECTIVE: Mindfulness interventions have been effective for improving a range of health outcomes; however, pathways underlying these effects remain unclear. Inflammatory processes may play a role, possibly through increased resistance of immune cells to the anti-inflammatory effects of glucocorticoids (i.e., glucocorticoid resistance, or GCR). Here, we conducted an initial examination of whether mindfulness training mitigates GCR among lonely older adults. METHODS: Lonely older adults (65-85 years; n = 190) were randomly assigned to an 8-week Mindfulness-Based Stress Reduction (MBSR) or a matched Health Enhancement Program (HEP). Whole blood drawn before and after the intervention and at 3-month follow-up was incubated with endotoxin and varying concentrations of dexamethasone, and interleukin-6 production was assessed using enzyme-linked immunosorbent assay. GCR was assessed as the concentration of dexamethasone required to decrease the stimulated interleukin-6 response by 50% (half maximal inhibitory concentration), with higher concentrations indicating greater GCR. Mixed-effects linear models tested time (pre, post, follow-up) by condition (MBSR versus HEP) effects. RESULTS: There was no overall time by condition effect on GCR across all time points. However, a significant time by condition effect was observed from preintervention to postintervention (d = 0.29), such that MBSR buffered increases in GCR observed in the HEP group. Although MBSR showed small, nonsignificant reductions in GCR from preintervention to 3-month follow-up, group differences were not maintained at the 3-month follow-up (d = 0.10). CONCLUSIONS: Results suggest that MBSR may protect against declines in the sensitivity of immune cells to the anti-inflammatory effects of glucocorticoids among at-risk lonely older adults and show value in studying this biological mechanism in future trials.Trial Registration: Clinical Trials identifier NCT02888600.
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Atención Plena , Glucocorticoides , Interleucina-6 , Estrés Psicológico/terapia , Resultado del TratamientoRESUMEN
Importance: Acute low back pain (LBP) is highly prevalent, with a presumed favorable prognosis; however, once chronic, LBP becomes a disabling and expensive condition. Acute to chronic LBP transition rates vary widely owing to absence of standardized operational definitions, and it is unknown whether a standardized prognostic tool (ie, Subgroups for Targeted Treatment Back tool [SBT]) can estimate this transition or whether early non-guideline concordant treatment is associated with the transition to chronic LBP. Objective: To assess the associations between the transition from acute to chronic LBP with SBT risk strata; demographic, clinical, and practice characteristics; and guideline nonconcordant processes of care. Design, Setting, and Participants: This inception cohort study was conducted alongside a multisite, pragmatic cluster randomized trial. Adult patients with acute LBP stratified by SBT risk were enrolled in 77 primary care practices in 4 regions across the United States between May 2016 and June 2018 and followed up for 6 months, with final follow-up completed by March 2019. Data analysis was conducted from January to March 2020. Exposures: SBT risk strata and early LBP guideline nonconcordant processes of care (eg, receipt of opioids, imaging, and subspecialty referral). Main Outcomes and Measures: Transition from acute to chronic LBP at 6 months using the National Institutes of Health Task Force on Research Standards consensus definition of chronic LBP. Patient demographic characteristics, clinical factors, and LBP process of care were obtained via electronic medical records. Results: Overall, 5233 patients with acute LBP (3029 [58%] women; 4353 [83%] White individuals; mean [SD] age 50.6 [16.9] years; 1788 [34%] low risk; 2152 [41%] medium risk; and 1293 [25%] high risk) were included. Overall transition rate to chronic LBP at six months was 32% (1666 patients). In a multivariable model, SBT risk stratum was positively associated with transition to chronic LBP (eg, high-risk vs low-risk groups: adjusted odds ratio [aOR], 2.45; 95% CI, 2.00-2.98; P < .001). Patient and clinical characteristics associated with transition to chronic LBP included obesity (aOR, 1.52; 95% CI, 1.28-1.80; P < .001); smoking (aOR, 1.56; 95% CI, 1.29-1.89; P < .001); severe and very severe baseline disability (aOR, 1.82; 95% CI, 1.48-2.24; P < .001 and aOR, 2.08; 95% CI, 1.60-2.68; P < .001, respectively) and diagnosed depression/anxiety (aOR, 1.66; 95% CI, 1.28-2.15; P < .001). After controlling for all other variables, patients exposed to 1, 2, or 3 nonconcordant processes of care within the first 21 days were 1.39 (95% CI, 1.21-2.32), 1.88 (95% CI, 1.53-2.32), and 2.16 (95% CI, 1.10-4.25) times more likely to develop chronic LBP compared with those with no exposure (P < .001). Conclusions and Relevance: In this cohort study, the transition rate to chronic LBP was substantial and increased correspondingly with SBT stratum and early exposure to guideline nonconcordant care.