Integrating a Community Advisory Board Into a Pragmatic Trial of Mindfulness for Chronic Low Back Pain.

Background: To improve the implementation of clinical trial interventions, there is a need to facilitate communication between key stakeholders and research teams. Community Advisory Boards (CAB) bring together a range of stakeholders not historically included in the research process to inform and work collaboratively with research teams. Objective: To describe our procedures and processes for (1) integration of a CAB into a pragmatic clinical trial of a telehealth-delivered group mindfulness program for persons with chronic low back pain (cLBP) within primary care, and (2) for the rapid uptake and implementation of CAB recommendations. Methods: The CAB we convened includes persons with cLBP who have undergone the mindfulness intervention, health care system leadership, advocacy groups, and mindfulness experts. The CAB members underwent a two hour initial training that introduced the research process and the CAB's role as research partners. The CAB met monthly for 1 hour. We used the Lighting Report method to summarize meetings and share feedback with the research team. Results: The recommendations of the CAB during the first year they met were divided into recruitment, informed consent, and survey recommendations. The study website also was overhauled based on recommendations, including a more engaging first page with rotating images of nature and testimonials. The language on the website was edited to be more concise and participant-friendly. The CAB recommended talking points to discuss with participants during screening or informed consent about the benefits of participating in research. Conclusion: We established a CAB that represented diverse perspectives, organizations, and experience with cLBP and mindfulness. The differing perspectives of the CAB resulted in recommendations that the research team itself would not have decided on their own. The Lightning Reports were also an effective way to efficiently communicate the CAB recommendations to the research team.

A Brief Measure of Fidelity for Mindfulness Programs: Development and Evaluation of the Concise Fidelity for Mindfulness-Based Interventions Tool.

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.

The design and methods of the OPTIMUM study: A multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain.

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.

Screening for Personality Disorders: A Three-Item Screener From the Inventory of Interpersonal Problems (IIP-3).

To encourage screening for personality disorders (PDs), we developed (in previous work) self-report scales for PDs using the Inventory of Interpersonal Problems (IIP). The combined score from three of the scales-inter-personal sensitivity, interpersonal ambivalence, and aggression-requiring 15 items (IIP-15) did the best job of distinguishing between respondents with any versus no PD. The goals for the present work were (a) to cross-validate the IIP-15 by examining its performance using receiver operating characteristics (ROC) analyses in a new sample (N = 410), and (b) to investigate the utility of a brief three-item variant (IIP-3). The present results again documented the good operating characteristics of the IIP-15. Sensitivity, specificity, and positive and negative predictive values were all above. 70. The operating characteristics of the IIP-3 were nearly as good despite its brevity and support its use as an initial screen for PDs.

An Item Bank for Abuse of Prescription Pain Medication from the Patient-Reported Outcomes Measurement Information System (PROMIS®).

OBJECTIVE: There is a need to monitor patients receiving prescription opioids to detect possible signs of abuse. To address this need, we developed and calibrated an item bank for severity of abuse of prescription pain medication as part of the Patient-Reported Outcomes Measurement Information System (PROMIS ® ). METHODS: Comprehensive literature searches yielded an initial bank of 5,310 items relevant to substance use and abuse, including abuse of prescription pain medication, from over 80 unique instruments. After qualitative item analysis (i.e., focus groups, cognitive interviewing, expert review, and item revision), 25 items for abuse of prescribed pain medication were included in field testing. Items were written in a first-person, past-tense format, with a three-month time frame and five response options reflecting frequency or severity. The calibration sample included 448 respondents, 367 from the general population (ascertained through an internet panel) and 81 from community treatment programs participating in the National Drug Abuse Treatment Clinical Trials Network. RESULTS: A final bank of 22 items was calibrated using the two-parameter graded response model from item response theory. A seven-item static short form was also developed. The test information curve showed that the PROMIS ® item bank for abuse of prescription pain medication provided substantial information in a broad range of severity. CONCLUSION: The initial psychometric characteristics of the item bank support its use as a computerized adaptive test or short form, with either version providing a brief, precise, and efficient measure relevant to both clinical and community samples.

Validation of the alcohol use item banks from the Patient-Reported Outcomes Measurement Information System (PROMIS).

BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS) includes five item banks for alcohol use. There are limited data, however, regarding their validity (e.g., convergent validity, responsiveness to change). To provide such data, we conducted a prospective study with 225 outpatients being treated for substance abuse. METHODS: Assessments were completed shortly after intake and at 1-month and 3-month follow-ups. The alcohol item banks were administered as computerized adaptive tests (CATs). Fourteen CATs and one six-item short form were also administered from eight other PROMIS domains to generate a comprehensive health status profile. After modeling treatment outcome for the sample as a whole, correlates of outcome from the PROMIS health status profile were examined. RESULTS: For convergent validity, the largest correlation emerged between the PROMIS alcohol use score and the Alcohol Use Disorders Identification Test (r=.79 at intake). Regarding treatment outcome, there were modest changes across the target problem of alcohol use and other domains of the PROMIS health status profile. However, significant heterogeneity was found in initial severity of drinking and in rates of change for both abstinence and severity of drinking during follow-up. This heterogeneity was associated with demographic (e.g., gender) and health-profile (e.g., emotional support, social participation) variables. CONCLUSIONS: The results demonstrated the validity of PROMIS CATs, which require only 4-6 items in each domain. This efficiency makes it feasible to use a comprehensive health status profile within the substance use treatment setting, providing important prognostic information regarding abstinence and severity of drinking.

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.

Evaluating PROMIS® instruments and methods for patient-centered outcomes research: Patient and provider voices in a substance use treatment setting.

PURPOSE: Our work as a primary research site of the Patient-Reported Outcomes Measurement Information System (PROMIS®), combined with support from the Patient-Centered Outcomes Research Institute, allowed us to evaluate the real-world applicability and acceptability of PROMIS measures in an addiction medicine setting. METHODS: As part of a 3-month prospective observational study, 225 outpatients at a substance abuse treatment clinic completed PROMIS item banks for alcohol use (as well as 15 additional item banks from 8 other PROMIS domains, including emotional distress, sleep, and pain), with assessments at intake, 1-month follow-up, and 3-month follow-up. A subsample of therapists and their patients completed health domain importance ratings and qualitative interviews to elicit feedback regarding the content and format of the patients' assessment results. RESULTS: The importance ratings revealed that depression, anxiety, and lack of emotional support were rated highest of the non-alcohol-related domains among both patients and clinicians. General alcohol use was considered most important by both patients and clinicians. Based on their suggestions, changes were made to item response feedback to facilitate comprehension and communication. CONCLUSIONS: Both therapists and patients agreed that their review of the graphical display of scores, as well as individual item responses, helped them to identify areas of greatest concern and was useful for treatment planning. The results of our pilot work demonstrated the value and practicality of incorporating a comprehensive health assessment within a substance abuse treatment setting.

Item banks for substance use from the Patient-Reported Outcomes Measurement Information System (PROMIS(®)): Severity of use and positive appeal of use.

BACKGROUND: Two item banks for substance use were developed as part of the Patient-Reported Outcomes Measurement Information System (PROMIS(®)): severity of substance use and positive appeal of substance use. METHODS: Qualitative item analysis (including focus groups, cognitive interviewing, expert review, and item revision) reduced an initial pool of more than 5300 items for substance use to 119 items included in field testing. Items were written in a first-person, past-tense format, with 5 response options reflecting frequency or severity. Both 30-day and 3-month time frames were tested. The calibration sample of 1336 respondents included 875 individuals from the general population (ascertained through an internet panel) and 461 patients from addiction treatment centers participating in the National Drug Abuse Treatment Clinical Trials Network. RESULTS: Final banks of 37 and 18 items were calibrated for severity of substance use and positive appeal of substance use, respectively, using the two-parameter graded response model from item response theory (IRT). Initial calibrations were similar for the 30-day and 3-month time frames, and final calibrations used data combined across the time frames, making the items applicable with either interval. Seven-item static short forms were also developed from each item bank. CONCLUSIONS: Test information curves showed that the PROMIS item banks provided substantial information in a broad range of severity, making them suitable for treatment, observational, and epidemiological research in both clinical and community settings.

Validation of the depression item bank from the Patient-Reported Outcomes Measurement Information System (PROMIS) in a three-month observational study.

The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative devoted to developing better measurement tools for assessing constructs relevant to the clinical investigation and treatment of all diseases-constructs such as pain, fatigue, emotional distress, sleep, physical functioning, and social participation. Following creation of item banks for these constructs, our priority has been to validate them, most often in short-term observational studies. We report here on a three-month prospective observational study with depressed outpatients in the early stages of a new treatment episode (with assessments at intake, one-month follow-up, and three-month follow-up). The protocol was designed to compare the psychometric properties of the PROMIS depression item bank (administered as a computerized adaptive test, CAT) with two legacy self-report instruments: the Center for Epidemiological Studies Depression scale (CESD; Radloff, 1977) and the Patient Health Questionnaire (PHQ-9; Spitzer et al., 1999). PROMIS depression demonstrated strong convergent validity with the CESD and the PHQ-9 (with correlations in a range from .72 to .84 across all time points), as well as responsiveness to change when characterizing symptom severity in a clinical outpatient sample. Identification of patients as "recovered" varied across the measures, with the PHQ-9 being the most conservative. The use of calibrations based on models from item response theory (IRT) provides advantages for PROMIS depression both psychometrically (creating the possibility of adaptive testing, providing a broader effective range of measurement, and generating greater precision) and practically (these psychometric advantages can be achieved with fewer items-a median of 4 items administered by CAT-resulting in less patient burden).

Assessment of self-reported negative affect in the NIH Toolbox.

We report on the selection of self-report measures for inclusion in the NIH Toolbox that are suitable for assessing the full range of negative affect including sadness, fear, and anger. The Toolbox is intended to serve as a "core battery" of assessment tools for cognition, sensation, motor function, and emotional health that will help to overcome the lack of consistency in measures used across epidemiological, observational, and intervention studies. A secondary goal of the NIH Toolbox is the identification of measures that are flexible, efficient, and precise, an agenda best fulfilled by the use of item banks calibrated with models from item response theory (IRT) and suitable for adaptive testing. Results from a sample of 1763 respondents supported use of the adult and pediatric item banks for emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(®)) as a starting point for capturing the full range of negative affect in healthy individuals. Content coverage for the adult Toolbox was also enhanced by the development of a scale for somatic arousal using items from the Mood and Anxiety Symptom Questionnaire (MASQ) and scales for hostility and physical aggression using items from the Buss-Perry Aggression Questionnaire (BPAQ).

Reliability and validity of the Shaw gait assessment tool for temporospatial gait assessment in people with hemiparesis.

OBJECTIVE: To assess the intra-/interrater reliability and the validity of the free web-based Shaw Gait Assessment Tool (with visual and numerical output) for assessing speed, cadence, step length, and limb advance time in people with hemiplegic gait. DESIGN: Intra-/interrater reliability and concurrent validity with 2 raters using the Shaw Gait Assessment Tool and 1 rater using a multimemory stopwatch. SETTING: Busy outpatient rehabilitation gym at a tertiary care medical center. PARTICIPANTS: Convenience sample of adults with hemiplegic gait after cerebrovascular accident or traumatic brain injury. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Intraclass correlation coefficients (ICCs) and Pearson product-moment correlation coefficients. RESULTS: ICCs for intrarater reliability ranged from 0.94 (95% CI, 0.88-0.97) to 0.98 (95% CI, 0.96-0.99), (P<.001), and for interrater reliability from 0.95 (95% CI, 0.88-0.98) to 0.99 (95% CI, 0.99-0.99), (P<.001). The Shaw Gait Assessment Tool correlated with the stopwatch for all measured gait parameters with Pearson product-moment correlation coefficients (range, r=0.95 to r= 0.99, P<.001). CONCLUSIONS: The Shaw Gait Assessment Tool is a free, easy-to-use tool that gives reliable and valid results for 4 temporospatial parameters of hemiplegic gait.

Fear and pain: investigating the interaction between aversive states.

Pain and fear often co-occur and appear to interact, although the nature and direction of their relation is not clearly delineated. The present study investigates how exposure to the experience of one of these states subsequently affects responding to the other. Pressure stimulation and carbon dioxide-enriched air (CO2) were used to induce pain and fear, respectively, in 48 healthy individuals. The order in which the stimuli were introduced was manipulated, as was the CO2 level. Measures of overt behavior, physiological responding, and self-report were obtained; analyses of stimuli effects generally supported their ability to produce pain or fear. Results indicate that the stimulus rated as the most aversive, the higher level of CO2, led to the highest levels of distressed responding across dependent measures. This pattern was replicated for the stimuli found to be less aversive (i.e., pressure stimulation and low-level CO2, respectively). The authors conclude that fear and pain, in and of themselves, do not dictate the nature of their interaction; the most important factor is how aversive they are perceived to be in relation to one another.