Mindfulness-Based Stress Reduction reduces pro-inflammatory gene regulation but not systemic inflammation among older adults: A randomized controlled trial.

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.

Costs of Implementing Electronic Context Factor Assessments and Patient-reported Outcomes in Pain Clinic Settings.

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.

Biobehavioral Assessments in BACPAC: Recommendations, Rationale, and Methods.

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.

Toward the Identification of Distinct Phenotypes: Research Protocol for the Low Back Pain Biological, Biomechanical, and Behavioral (LB3P) Cohort Study and the BACPAC Mechanistic Research Center at the University of Pittsburgh.

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.

The Back Pain Consortium (BACPAC) Research Program Data Harmonization: Rationale for Data Elements and Standards.

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.

CAPER: patient preferences to inform nonsurgical treatment of chronic low back pain: a discrete-choice experiment.

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.

Effectiveness of spinal manipulation and biopsychosocial self-management compared to medical care for low back pain: a randomized trial study protocol.

BACKGROUND: Chronic low back pain (cLBP) is widespread, costly, and burdensome to patients and health systems. Little is known about non-pharmacological treatments for the secondary prevention of cLBP. There is some evidence that treatments addressing psychosocial factors in higher risk patients are more effective than usual care. However, most clinical trials on acute and subacute LBP have evaluated interventions irrespective of prognosis. METHODS: We have designed a phase 3 randomized trial with a 2 × 2 factorial design. The study is also a Hybrid type 1 trial with focus on intervention effectiveness while simultaneously considering plausible implementation strategies. Adults (n = 1000) with acute/subacute LBP at moderate to high risk of chronicity based on the STarT Back screening tool will be randomized in to 1 of 4 interventions lasting up to 8 weeks: supported self-management (SSM), spinal manipulation therapy (SMT), both SSM and SMT, or medical care. The primary objective is to assess intervention effectiveness; the secondary objective is to assess barriers and facilitators impacting future implementation. Primary effectiveness outcome measures are: (1) average pain intensity over 12 months post-randomization (pain, numerical rating scale); (2) average low back disability over 12 months post-randomization (Roland-Morris Disability Questionnaire); (3) prevention of cLBP that is impactful at 10-12 months follow-up (LBP impact from the PROMIS-29 Profile v2.0). Secondary outcomes include: recovery, PROMIS-29 Profile v2.0 measures to assess pain interference, physical function, anxiety, depression, fatigue, sleep disturbance, and ability to participate in social roles and activities. Other patient-reported measures include LBP frequency, medication use, healthcare utilization, productivity loss, STarT Back screening tool status, patient satisfaction, prevention of chronicity, adverse events, and dissemination measures. Objective measures include the Quebec Task Force Classification, Timed Up & Go Test, the Sit to Stand Test, and the Sock Test assessed by clinicians blinded to the patients' intervention assignment. DISCUSSION: By targeting those subjects at higher risk this trial aims to fill an important gap in the scientific literature regarding the effectiveness of promising non-pharmacological treatments compared to medical care for the management of patients with an acute episode of LBP and the prevention of progression to a severe chronic back problem. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03581123.

Mindfulness-based stress reduction increases stimulated IL-6 production among lonely older adults: A randomized controlled trial.

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.

Mindfulness-Based Stress Reduction Buffers Glucocorticoid Resistance Among Older Adults: A Randomized Controlled Trial.

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.

Resolving the Burden of Low Back Pain in Military Service Members and Veterans (RESOLVE): Protocol for a Multisite Pragmatic Clinical Trial.

BACKGROUND: Physical therapy (PT) is frequently used for the management of low back pain (LBP) within the US Departments of Defense (DOD) and Veterans Affairs (VA). However, variations in PT practice patterns and use of ineffective interventions lower the quality and increase the cost of care. Although adherence to the clinical practice guidelines (CPGs) can improve the outcomes and cost-effectiveness of LBP care, PT CPG adherence remains below 50%. The Resolving the Burden of Low Back Pain in Military Service Members and Veterans (RESOLVE) trial will evaluate the effectiveness of an active PT CPG implementation strategy using an education, audit, and feedback model for reducing pain, disability, medication use, and cost of LBP care within the DOD and VA health care systems. DESIGN: The RESOLVE trial will include 3,300 to 7,260 patients with LBP across three DOD and two VA medical facilities using a stepped-wedge study design. An education, audit, and feedback model will be used to encourage physical therapists to better adhere to the PT CPG recommendations. The Oswestry Disability Index and the Defense and Veterans Pain Rating Scale will be used as primary outcomes. Secondary outcomes will include the LBP-related medication use, medical resource utilization, and biopsychosocial predictors of outcomes. Statistical analyses will be based on the intention-to-treat principle and will use linear mixed models to compare treatment conditions and examine the interactions between treatment and subgrouping status (e.g., limb loss). SUMMARY: The RESOLVE trial will provide a pragmatic approach to evaluate whether better adherence to PT CPGs can reduce pain, disability, medication use, and LBP care cost within the DOD and VA health care systems.

Mindfulness for Chronic Low Back Pain: A Qualitative Analysis.

Objective: Mindfulness is a nonpharmacologic mind-body therapy that has been shown to be effective in older adults with chronic low back pain (cLBP). There are few first-person accounts in the literature that describe the older adult experience and perspective while learning mindfulness and meditation to treat pain. The objective of this study was to investigate dominant themes present in the experiences of older adults applying mindfulness and meditation to cope with cLBP. Design: Qualitative analysis of four focus groups. Subject: Twenty-five adults age 65 years or older who had completed an eight-week mindfulness program. Methods: The focus groups met for a comprehensive discussion session about their experience with mindfulness and meditation. The audio for each session was recorded, and the discussions were transcribed. Codebook development, qualitative coding, and thematic analysis were performed. The coders each coded all four transcripts, following which they met to adjudicate all coding differences until they were in complete agreement on coding. Results: Several key themes were brought up by older adults utilizing mindfulness as a means of coping with pain, which included overcoming fear of pain ("Before [learning mindfulness], I used to dread pain"), pain awareness ("You're focusing more on being aware than the pain; now that's what helps me"), and pain significance ("It becomes insignificant"). Conclusions: The themes identify several ways mindfulness impacts older adults with cLBP, including decreased negative emotions related to chronic pain such as fear of pain, a different perspective or change in awareness about pain, and reducing the significance of pain.

Mindfulness Meditation Training and Executive Control Network Resting State Functional Connectivity: A Randomized Controlled Trial.

OBJECTIVE: Mindfulness meditation training has been previously shown to enhance behavioral measures of executive control (e.g., attention, working memory, cognitive control), but the neural mechanisms underlying these improvements are largely unknown. Here, we test whether mindfulness training interventions foster executive control by strengthening functional connections between dorsolateral prefrontal cortex (dlPFC)-a hub of the executive control network-and frontoparietal regions that coordinate executive function. METHODS: Thirty-five adults with elevated levels of psychological distress participated in a 3-day randomized controlled trial of intensive mindfulness meditation or relaxation training. Participants completed a resting state functional magnetic resonance imaging scan before and after the intervention. We tested whether mindfulness meditation training increased resting state functional connectivity (rsFC) between dlPFC and frontoparietal control network regions. RESULTS: Left dlPFC showed increased connectivity to the right inferior frontal gyrus (T = 3.74), right middle frontal gyrus (MFG) (T = 3.98), right supplementary eye field (T = 4.29), right parietal cortex (T = 4.44), and left middle temporal gyrus (T = 3.97, all p < .05) after mindfulness training relative to the relaxation control. Right dlPFC showed increased connectivity to right MFG (T = 4.97, p < .05). CONCLUSIONS: We report that mindfulness training increases rsFC between dlPFC and dorsal network (superior parietal lobule, supplementary eye field, MFG) and ventral network (right IFG, middle temporal/angular gyrus) regions. These findings extend previous work showing increased functional connectivity among brain regions associated with executive function during active meditation by identifying specific neural circuits in which rsFC is enhanced by a mindfulness intervention in individuals with high levels of psychological distress. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov,NCT01628809.

Measuring nonspecific factors in treatment: item banks that assess the healthcare experience and attitudes from the patient's perspective.

PURPOSE: Nonspecific factors that accompany healthcare treatments, such as patients' attitudes and expectations, are important parts of the experience of care and can influence outcomes. However, no precise, concise, and generalizable instruments to measure these factors exist. We report on the development and calibration of new item banks, titled the Healing Encounters and Attitudes Lists (HEAL), that assess nonspecific factors across a broad range of treatments and conditions. METHODS: The instrument development methodology of the Patient-Reported Outcomes Measurement Information System (PROMIS(®)) was used. Patient focus groups and clinician interviews informed our HEAL conceptual model. Literature searches of eight databases yielded over 500 instruments and resulted in an initial item pool of several thousand items. After qualitative item analysis, including cognitive interviewing, 296 items were included in field testing. The calibration sample included 1657 respondents, 1400 obtained through an Internet panel and 257 from conventional and integrative medicine clinics. Following exploratory and confirmatory factor analyses, the HEAL item banks were calibrated using item response theory. RESULTS: The final HEAL item banks were Patient-Provider Connection (57 items), Healthcare Environment (25 items), Treatment Expectancy (27 items), Positive Outlook (27 items), and Spirituality (26 items). Short forms were also developed from each item bank. A six-item short form, Attitudes toward Complementary and Alternative Medicine (CAM), was also created. CONCLUSIONS: HEAL item banks provided substantial information across a broad range of each construct. HEAL item banks showed initial evidence of predictive and concurrent validity, suggesting that they are suitable for measuring nonspecific factors in treatment.

The design and methods of genetic studies on acute and chronic postoperative pain in patients after total knee replacement.

OBJECTIVE: Total knee replacement (TKR) is the treatment option of choice for the millions of individuals whose osteoarthritis pain can no longer be managed through non-invasive methods. Over 500,000 TKRs are performed annually in the United States. Although most patients report improvement in pain and functioning following TKR, up to 30% report persistent pain that interferes with daily function. However, the reasons for poor outcomes are not clear. To best determine which patients are at risk for pain post TKR, a detailed and comprehensive approach is needed. In this article, we present the methodology of a study designed to identify a set of genetic, proteomic, clinical, demographic, psychosocial, and psychophysical risk factors for severe acute and chronic pain post TKR. DESIGN: Prospective longitudinal observational study. SETTING: University Hospital System. SUBJECTS: Patients scheduled for unilateral TKR with a target number of 150. METHODS: Prior to surgery, we collect demographic, psychosocial, and pain data. Biological data, including blood samples for genetic analyses, and serum, urine, and joint fluid for cytokine assessment are collected intraoperatively. Pain assessments as well as medication use are collected during each of the three days postsurgery. Additionally, pain and psychosocial information is collected 6 and 12 months following surgery. CONCLUSIONS: This study, for the first time, captures the information on both genetic and "environmental" risk factors for acute and chronic pain post-TKR and has the potential to lead to the next step-multicenter large-scale studies on predictors and biomarkers of poor TKR outcomes as well as on tailored interventions and personalized medicine approaches for those at risk.

Using PROMIS Methodology to Create Self-Report Measures of Mindfulness and Related Concepts.

Background: Mindfulness meditation is ubiquitous in health care, education, and communities at large. Mindfulness-Based Interventions (MBIs) are the focus of hundreds of NIH-funded trials given the myriad health benefits associated with this practice across multiple populations. Notwithstanding, significant gaps exist in how mindfulness concepts are measured using currently available self-report instruments. Due to the number of available mindfulness measurement tools, each measuring different aspects, it is difficult to determine the extent to which individuals develop comparable mindfulness skills and attitudes and which health benefits can be attributed to which gains in mindfulness. The Patient-Reported Outcomes Measurement Information System (Puerto RicoOMIS®) has established a rigorous instrument development methodology to create brief, precise, and clinically relevant outcomes tools. Objective: This is the first of 4 papers representing an NCCIH-funded initiative (R01AT009539), which has applied Puerto RicoOMIS® instrument development methodologies to mindfulness measurement to improve the rigor, relevance, and reproducibility of MBI research results. Methods/Results: This introductory paper sets the stage for why improved mindfulness measurement tools are needed and briefly describes the Puerto RicoOMIS® development approach. The second 2 papers highlight results from a national survey, focus groups, and expert interviews to identify and organize relevant mindfulness concepts, domains, and items for eventual item bank creation. The fourth paper reviews the item writing and development process of these new instruments, including results from stakeholder cognitive interviews and a translatability review. Conclusion: Together these papers feature the rigorous development approach, rationale, logic, and significance that supports the development, calibration, and validation of new Puerto RicoOMIS® measures of mindfulness and related concepts.

Updated review of complementary and alternative medicine treatments for systemic lupus erythematosus.

It is estimated that over 50 % of patients with systemic lupus erythematosus (SLE) have utilized complementary and alternative medicine (CAM) treatments to reduce symptoms and manage their health. However, there are relatively few randomized controlled trials of CAM for SLE. This review describes recent studies of vitamins and supplements, acupuncture, and mind-body interventions in SLE patients. The recent trials of CAM treatments for SLE indicate that supplements such as vitamin D, omega 3 fatty acids, N-acetyl cysteine and turmeric show some promise for reducing SLE disease activity. In addition, mind-body methods such as cognitive-behavioral therapy and other counseling interventions may improve mood and quality of life in SLE.

Item Understanding of Common Quality of Life Measures for use with Autistic Adults.

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.

Psychologically Informed Practice: The Importance of Communication in Clinical Implementation.

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.

Pain acceptance and psychological inflexibility predict pain interference outcomes for persons with chronic pain receiving pain psychology.

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.

The Psychologically Informed Practice Consultation Roadmap: A Clinical Implementation Strategy.

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.