Documenting Compliance and Symptom Reactivity for Ambulatory Assessment Methodology Following Concussion in Adolescents and Young Adults: Feasibility of the Mobile Neurocognitive Health (MNCH) Project.

OBJECTIVE: Evaluate compliance, symptom reactivity, and acceptability/experience ratings for an ecological momentary assessment (EMA) protocol involving ultra-brief ambulatory cognitive assessments in adolescent and young adult patients with concussion. SETTING: Outpatient concussion clinic. PARTICIPANTS: 116 patients aged 13 to 25 years with concussion. DESIGN: Prospective research design was used to examine compliance, symptom reactivity, and acceptability/experience for the Mobile Neurocognitive Health Project (MNCH); an EMA study of environmental exposures, symptoms, objective cognitive functioning, and symptom reactivity involving 4, daily EMA surveys (7:30 am, 10:30 am, 3:00 pm, 8:00 pm) for a period of 7 days following concussion. Overall compliance rates, symptom reactivity scores, and participant acceptability/experience ratings were described. A series of non-parametric Friedman Tests with post-hoc Wilcoxon signed-rank tests were used to examine differences in compliance and reactivity related to time of day and over the course of the protocol (first 3 days [Early Week] vs last 4 days [Late Week]). MAIN MEASURES: Compliance rates, symptom reactivity scores, participant experience/acceptability. RESULTS: Overall median compliance was 71%, and there were significantly fewer 7:30 am surveys completed compared to the 10:30 am (Z = -4.88,P ≤ .001), 3:00 pm (Z = -4.13,P ≤ .001), and 8:00 pm (Z = -4.68, P ≤ .001) surveys. Compliance for Early Week surveys were significantly higher than Late Week (Z = -2.16,P = .009). The median symptom reactivity score was 34.39 out of 100 and was significantly higher for Early Week compared to Late Week (Z = -4.59,P ≤ .001). Ninety-nine percent (89/90) of the sample agreed that the app was easy to use, and 18% (16/90) indicated that the app interfered with their daily life. CONCLUSION: Adolescents and young adults with concussion were compliant with the MNCH EMA protocol. Symptom reactivity to the protocol was low and the majority of participants reported that the app and protocol were acceptable. These findings support further investigation into applications of EMA for use in concussion studies.

A Common Data Element-Based Adjudication Process for mTBI Clinical Profiles: A Targeted Multidomain Clinical Trial Preliminary Study.

INTRODUCTION: The primary purpose of this study was to examine the prevalence and percent agreement of clinician-identified mild traumatic brain injury (mTBI) clinical profiles and cutoff scores for selected Federal Interagency Traumatic Brain Injury Research common data elements (CDEs). A secondary purpose was to investigate the predictive value of established CDE assessments in determining clinical profiles in adults with mTBI. MATERIALS AND METHODS: Seventy-one (23 males; 48 females) participants (M = 29.00, SD = 7.60, range 18-48 years) within 1-5 months (M = 24.20, SD = 25.30, range 8-154 days) of mTBI completed a clinical interview/exam and a multidomain assessment conducted by a licensed clinician with specialized training in concussion, and this information was used to identify mTBI clinical profile(s). A researcher administered CDE assessments to all participants, and scores exceeding CDE cutoffs were used to identify an mTBI clinical profile. The clinician- and CDE-identified clinical profiles were submitted to a multidisciplinary team for adjudication. The prevalence and percent agreement between clinician- and CDE-identified clinical profiles was documented, and a series of logistic regressions with adjusted odds ratios were performed to identify which CDE assessments best predicted clinician-identified mTBI clinical profiles. RESULTS: Migraine/headache, vestibular, and anxiety/mood mTBI clinical profiles exhibited the highest prevalence and overall percent agreement among CDE and clinician approaches. Participants exceeding cutoff scores for the Global Severity Index and Headache Impact Test-6 assessments were 3.90 and 8.81 times more likely to have anxiety/mood and migraine/headache profiles, respectively. The Vestibular/Ocular Motor Screening vestibular items and the Pittsburgh Sleep Quality Index total score were predictive of clinician-identified vestibular and sleep profiles, respectively. CONCLUSIONS: The CDEs from migraine/headache, vestibular, and anxiety/mood domains, and to a lesser extent the sleep modifier, may be clinically useful for identifying patients with these profiles following mTBI. However, CDEs for cognitive and ocular may have more limited clinical value for identifying mTBI profiles.

Targeted multidomain intervention for complex mTBI: protocol for a multisite randomized controlled trial in military-age civilians.

Background: Mild traumatic brain injury (mTBI) affects ~18,000 military personnel each year, and although most will recover in 3-4 weeks, many experience persisting symptoms and impairment lasting months or longer. Current standard of care for U.S. military personnel with complex mTBI involves initial (<48 h) prescribed rest, followed by behavioral (e.g., physical activity, sleep regulation, stress reduction, hydration, nutrition), and symptom-guided management. There is growing agreement that mTBI involves different clinical profiles or subtypes that require a comprehensive multidomain evaluation and adjudication process, as well as a targeted approach to treatment. However, there is a lack of research examining the effectiveness of this approach to assessing and treating mTBI. This multisite randomized controlled trial (RCT) will determine the effectiveness of a targeted multidomain (T-MD) intervention (anxiety/mood, cognitive, migraine, ocular, vestibular; and sleep, autonomic) compared to usual care (behavioral management) in military-aged civilians with complex mTBI. Methods: This study employs a single-blinded, two-group repeated measures design. The RCT will enroll up to 250 military-aged civilians (18-49 yrs) with a diagnosed complex mTBI within 8 days to 6 months of injury from two concussion specialty clinics. The two study arms are a T-MD intervention and a usual care, behavioral management control group. All participants will complete a comprehensive, multidomain clinical evaluation at their first clinical visit. Information gathered from this evaluation will be used to adjudicate mTBI clinical profiles. Participants will then be randomized to either the 4-week T-MD or control arm. The T-MD group will receive targeted interventions that correspond to the patient's clinical profile (s) and the control group will receive behavioral management strategies. Primary outcomes for this study are changes from enrollment to post-intervention on the Neurobehavioral Symptom Inventory (NSI), Patient Global Impression of Change (PGIC), and functional near-infrared spectroscopy (fNIRS). Time to return to activity (RTA), and healthcare utilization costs will also be assessed. Discussion: Study findings may inform a more effective approach to treat complex mTBI in military personnel and civilians, reduce morbidity, and accelerate safe return-to-duty/activity. Ethics and dissemination: The study is approved by the University of Pittsburgh Institutional Review board and registered at clinicaltrials.gov. Dissemination plans include peer-reviewed publications and presentations at professional meetings. Clinical Trial Registration: www.clinicaltrials.gov, identifier: NCT04549532.

Ambulatory Assessment in Concussion Clinical Care and Rehabilitation.

Concussion is a mild traumatic brain injury that is characterized by a wide range of physical, emotional, and cognitive symptoms as well as neurocognitive, vestibular, and ocular impairments that can negatively affect daily functioning and quality of life. Clinical consensus statements recommend a targeted, clinical profile-based approach for management and treatment. This approach requires that clinicians utilize information obtained via a clinical interview and a multi-domain assessment battery to identify clinical profile(s) (e.g., vestibular, mood/anxiety, ocular, migraine, cognitive fatigue) and prescribe a corresponding treatment/rehabilitation program. Despite this comprehensive approach, the clinical picture can be limited by the accuracy and specificity of patient reports (which often conflate timing and severity of symptomology), as well as frequency and duration of exposure to symptom exacerbating environments (e.g., busy hallways, sitting in the back seat of a car). Given that modern rehabilitation programs leverage the natural environment as a tool to promote recovery (e.g., expose-recover approach), accurate characterization of the patient clinical profile is essential to improving recovery outcomes. Ambulatory assessment methodology could greatly benefit concussion clinical care by providing a window into the symptoms and impairments experienced by patients over the course of their daily lives. Moreover, by evaluating the timing, onset, and severity of symptoms and impairments in response to changes in a patient's natural environment, ambulatory assessments can provide clinicians with a tool to confirm clinical profiles and gauge effectiveness of the rehabilitation program. In this perspective report, we review the motivations for utilizing ambulatory assessment methodology in concussion clinical care and report on data from a pilot project utilizing smart phone-based, ambulatory assessments to capture patient reports of symptom severity, environmental exposures, and performance-based assessments of cognition for 7 days following their initial evaluation.

Assessing disease experience across the life span for individuals with osteogenesis imperfecta: challenges and opportunities for patient-reported outcomes (PROs) measurement: a pilot study.

BACKGROUND: Patient reported outcome (PRO) information is crucial for establishing better patient-provider communication, improving shared decision-making between clinicians and patients, assessing patient responses to therapeutic interventions, and increasing satisfaction with care. We used the Brittle Bones Disease Consortium (BBDC) Contact Registry for People with OI, managed by the Rare Disease Clinical Research Network (RDCRN) to (1) to evaluate the construct validity of the Patient-Reported Outcome Measurement Information System® (PROMIS®) to record important components of the disease experience among individuals with OI; and (2) explore the feasibility of using a registry to recruit individuals with OI to report on health status. Our long-term goal is to enhance communication of health and disease management findings back to the OI community, especially those who do not have access to major OI clinical centers. RESULTS: We demonstrated the construct validity of PROMIS instruments in OI. Our results confirm that the scores from most domains differ significantly from the general US population: individuals with OI have worse symptom burden and functioning. We found no excessive floor or ceiling effects. Our study demonstrates that the BBDC Contact Registry can be used to recruit participants for online health status surveys. However, there are numerous challenges that must be addressed: lack of self-knowledge of OI type, under-representation of men, limited ethnic diversity, and imperfect questionnaire completion rates. CONCLUSION: Our pilot study demonstrated the feasibility of using a contact registry to recruit respondents from the OI community and to obtain analyzable PROMIS data regarding disease experience. Because the results differ from the general population and avoid excessive floor and ceiling effects, PROMIS instruments can be used to assess response to therapeutic interventions in individuals with OI. Future directions will include (1) development and validation of an OI-specific patient-based classification system that aggregates persons with similar clinical characteristics and risks for complications to identify treatment needs; and (2) integrating these PRO tools into routine patient care and research studies.