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.

Reliable Change Indices for the Serial Administration of the Concussion Clinical Profiles Screening Tool.

CONTEXT: The Concussion Clinical Profile Screening Tool (CP Screen) self-report concussion symptom inventory that is often administered at weekly intervals. However, 1-week reliable change indices (RCI) for clinical cutoffs and the test-retest reliability of the CP Screen is unknown. OBJECTIVE: Document RCI cutoff scores and 1-week test-retest reliability for each profile and modifier of the CP Screen for males and females. DESIGN: Case Series. SETTING: A large US university. PATIENTS OR OTHER PARTICIPANTS: 173 healthy college students. MAIN OUTCOME MEASURE(S): Participants completed two administrations of the CP Screen 7 days apart; CP Screen items yield five clinical profiles and two modifiers. Spearman rho coefficients (rs), intraclass correlation coefficients (ICCs) single measures and Unbiased Estimates of Reliability (UER) were used to assess test-retest reliability. Wilcoxon signed-rank tests assessed differences across time. RCI values and cutoff scores are provided at 90%/95% confidence intervals (CI). All analyses were performed for the total sample and separately for males and females. RESULTS: RCI cutoffs for clinically significant change (increase/decrease) at a 90% CI for males were as follows: Ocular, Vestibular >2/>4, Anxiety/Mood, Cognitive/Fatigue, Migraine>3/>3, Sleep >4/>6, and Neck>2/>2. RCI cutoffs for clinically significant change (increase/decrease) at a 90% CI for females were as follows: Anxiety/Mood≥2/≥4; Cognitive/Fatigue, Migraine, Ocular, Vestibular, Sleep≥3/≥3; and Neck≥1/≥1. Correlations for CP ranged from .51 (Migraine) to .79 (Anxiety/Mood) for the total sample, .48 (Migraine) to .84 (Vestibular) for males, and .51 (Migraine) to .77 (Ocular) for females. Test-retest indices for each profile and modifier were moderate to good for the total sample (ICC: .64-.82; UER: .79-.90), males (ICC: .60-.87; UER: .76-.94), and females (ICC: .64-.80; UER: .78-.89). CONCLUSION: The CP Screen is reliable and stable across a 1-week interval, and established RCIs for males and females can help identify meaningful change throughout recovery.

The Effects of Rest on Concussion Symptom Resolution and Recovery Time: A Meta-analytic Review and Subgroup Analysis of 4329 Patients.

BACKGROUND: Numerous individual studies suggest that rest may have a negative effect on outcomes following concussion. PURPOSE: To perform a systematic meta-analysis of the effects of prescribed rest compared with active interventions after concussion. STUDY DESIGN: Meta-analysis; Level of evidence, 4. METHODS: A meta-analysis (using the Hedges g) of randomized controlled trials and cohort studies was conducted to evaluate the effects of prescribed rest on symptoms and recovery time after concussion. Subgroup analyses were performed for methodological, study, and sample characteristics. Data sources were obtained from systematic search of key terms using Ovid Medline, Embase, Cochrane Database of Systematic Reviews, APA PsycINFO, Web of Science, SPORTDiscus, and ProQuest dissertations and theses through May 28, 2021. Eligible studies were those that (1) assessed concussion or mild traumatic brain injury; (2) included symptoms or days to recovery for ≥2 time points; (3) included 2 groups with 1 group assigned to rest; and (4) were written in the English language. RESULTS: In total, 19 studies involving 4239 participants met criteria. Prescribed rest had a significant negative effect on symptoms (k = 15; g = -0.27; SE = 0.11; 95% CI, -0.48 to -0.05; P = .04) but not on recovery time (k = 8; g = -0.16; SE = 0.21; 95% CI, -0.57 to 0.26; P = .03). Subgroup analyses suggested that studies with shorter duration (<28 days) (g = -0.46; k = 5), studies involving youth (g = -0.33; k = 12), and studies focused on sport-related concussion (g = -0.38; k = 8) reported higher effect sizes. CONCLUSION: The findings support a small negative effect for prescribed rest on symptoms after concussion. Younger age and sport-related mechanisms of injury were associated with a greater negative effect size. However, the lack of support for an effect for recovery time and the relatively small overall numbers of eligible studies highlight ongoing concerns regarding the quantity and rigor of clinical trials in concussion. REGISTRATION: CRD42021253060 (PROSPERO).

Does time since concussion alter the factor structure of a multidomain assessment in adolescents?

The utilization of principal component analysis (PCA) approaches to concussion is beneficial to inform the interpretation of clinical outcome data in adolescent patients. While researchers have identified factors using post-concussive symptom scales and cognitive testing, there has yet to be a PCA that incorporates vestibular or oculomotor outcomes, or that focuses exclusively on adolescents. Moreover, the role of time since injury has not been examined in relation to concussion factors in this at-risk population. PCA methods were applied to two independent samples of 237 adolescents who presented to an outpatient concussion clinic: 1) ≤7 days (n = 145), and 2) 8 days-1 month (n = 92). The two separate PCAs included nine clinical assessments comprised of: a) four symptoms factors (cognitive/fatigue/migraine, affective, somatic, sleep), b) memory and speeded cognitive performance, c) near point of convergence (NPC), d) oculomotor, and e) vestibular outcomes. A three-component model including 1) symptoms, 2) cognitive, and 3) vestibular/oculomotor factors that accounted for 69.2% of the variance was supported for the ≤7 days sample. All items except somatic symptoms loaded. A different three-component model was supported for the 8 days-1 month sample, including 1) vestibulo-ocular migraine, 2) visuo-cognitive, and 3) affective-sleep that accounted for 72.1% of the variance, with all items loading. The findings supported two different concussion factor models that highlight the influence of time since injury and importance of considering vestibular and oculomotor outcomes in adolescents. Clinicians should evaluate these different factors using a comprehensive, multi domain approach to better inform assessment and monitor recovery in adolescent patients following concussion.Abbreviations: Principal Components Analysis (PCA), Immediate Post-concussion Assessment and Cognitive Testing (ImPACT), Post-concussion Symptom Scale (PCSS), Vestibular/Ocular Motor Screening (VOMS).

A Within-Subjects Comparison of Clinical Outcomes for Patients' First and Second Concussions.

OBJECTIVES: To examine the difference between an individual's first and second concussion using a comprehensive, multidomain assessment including symptoms, neurocognitive, vestibular, ocular, and individual demographic and medical history risk factors associated with protracted recovery. SETTING: Concussion Specialty Clinic. PARTICIPANTS: Seventy-three patients (aged 13-21 years; 57% female) diagnosed with 2 separate concussions (380.5 ± 278.7 days between injuries) from August 2016 to August 2018. DESIGN: Retrospective within-subjects cohort study. MAIN MEASURES: ImPACT, PCSS, and Vestibular-Ocular Motor Screen (VOMS) at each visit. Patients were divided into "normal" (≤30 days) and "protracted" recovery (>30 days) for χ2 analyses. RESULTS: There were no differences between the first and second injuries in recovery time, VOMS, visual and verbal memory, or reaction time. Visual motor speed scores were higher at the second injury time point and reported sleep symptoms were higher at the first injury time point. In addition, participants reported to the clinic on average 3 days earlier for an evaluation for their second injury. Results from χ2 analyses indicated that female sex predicted protracted recovery (>30 days) from concussion at the first injury time point (OR = 4.1; 95% CI, 1.5-11.6; P = .006). CONCLUSIONS: The findings provide preliminary evidence that there is no clinical difference between patients' first and second concussions when both injuries were treated through a concussion specialty clinic.

Neuropsychological Assessment of Sport-Related Concussion.

Neuropsychological assessment is a key component in a comprehensive, multidisciplinary approach to assessment of sport-related concussion (SRC). Currently computerized tests are the most commonly used modality of neurocognitive testing and involve both baseline and postinjury assessments. A comprehensive neuropsychological assessment should not only include neurocognitive testing but also incorporate symptom inventories, vestibular-ocular screening, and a psychological evaluation. Neuropsychological assessments are most effective when completed by a Clinical Neuropsychologist, given their specialized training in test interpretation and conceptualization of the psychological, cognitive, behavioral, physiologic, as well as neurologic principals when treating and managing SRC.

The sexual health of female rectal and anal cancer survivors: results of a pilot randomized psycho-educational intervention trial.

BACKGROUND: Sexual dysfunction is a frequently reported consequence of rectal/anal cancer treatment for female patients. PURPOSE: The purpose of this study was to conduct a small randomized controlled trial to assess the efficacy of a telephone-based, four-session Cancer Survivorship Intervention-Sexual Health (CSI-SH). METHODS: Participants (N = 70) were stratified by chemotherapy, stoma, and menopause statuses before randomization to CSI-SH or assessment only (AO). Participants were assessed at baseline, 4 months (follow-up 1), and 8 months (follow-up 2). RESULTS: The intervention had medium effect sizes from baseline to follow-up 1, which decreased by follow-up 2. Effect sizes were larger among the 41 sexually active women. Unadjusted means at the follow-ups were not significantly different between the treatment arms. Adjusting for baseline scores, demographics, and medical variables, the intervention arm had significantly better emotional functioning at follow-ups 1 and 2 and less cancer-specific stress at follow-up 1 compared to the AO arm. CONCLUSION: The data supported the hypothesized effects on improved sexual and psychological functioning and quality of life in CSI-SH female rectal/anal cancer survivors compared to the AO condition. This pilot study (N = 70) of CSI-SH supported the impact of this intervention on sexual and psychological functioning and quality of life on rectal and anal cancer survivors compared with an AO condition. However, intervention effects were stronger at follow-up 1 as compared to follow-up 2 and were stronger for sexually active women. IMPLICATIONS FOR CANCER SURVIVORS: Women may benefit from a brief, four-session, sexual health intervention after treatment from rectal and anal cancer.

Men's experience with sexual dysfunction post-rectal cancer treatment: a qualitative study.

In an effort to address reports from men that their sex life is worse after treatment for rectal cancer, this qualitative study was designed to better understand their experience with sexual dysfunction following rectal cancer treatment, thus providing information on the adaptation of a psycho-educational sexual health intervention for male rectal cancer survivors and simultaneously investigating barriers and promoters that would influence their participation in a psycho-educational sexual health intervention. Thirteen male rectal cancer survivors who were treated at Memorial Sloan-Kettering Cancer Center (MSKCC) for rectal cancer participated (median time post-treatment was 6.4 years). Six survivors participated in individual semi-structured phone interviews, and seven others took part in focus groups. We performed standard procedures of qualitative thematic text analysis, which involved independent review of interview and focus group transcripts by several analysts followed by consensus meetings to identify key themes. Participants reported bowel dysfunction (N = 13, or 100%) and erectile dysfunction (N = 12, or 92%) as chief complaints. The participants thought a psychoeducational sexual health intervention post-surgery would be helpful because it would provide educational information regarding the etiology of their problems and treatments to improve their sexual health (N = 8, or 62%). Most participants' primary concern immediately after treatment was surviving their disease; improving sexual functioning seemed to become more important over time. Barriers to potentially participating in a psycho-educational sexual health intervention included geographical distance from MSKCC (N = 3, or 3/13) and the risk of embarrassment when discussing sexual issues (N = 5, or 5/13). Men reported that a psycho-educational sexual health intervention would be helpful to improve their sexual functioning post-treatment. Discussion of bowel issues and logistical concerns gave information on the psycho-educational sexual health intervention.

Psychological correlates of sexual dysfunction in female rectal and anal cancer survivors: analysis of baseline intervention data.

INTRODUCTION: Sexual dysfunction represents a complex and multifactorial construct that can affect both men and women and has been noted to often deteriorate significantly after treatment for rectal and anal cancer. Despite this, it remains an understudied, underreported, and undertreated issue in the field of cancer survivorship. AIM: This study examined the characteristics of women enrolled in an intervention trial to treat sexual dysfunction, and explored the relationship between sexual functioning and psychological well-being. METHODS: There were 70 female posttreatment anal or rectal cancer survivors assessed as part of the current study. Participants were enrolled in a randomized intervention trial to treat sexual dysfunction and completed outcome measures prior to randomization. MAIN OUTCOMES MEASURES: The main outcome measures are quality of life (QOL) (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC-QLQ-C30] and Colorectal Cancer-Specific Module [QLQ-CR38]), sexual functioning (Female Sexual Functioning Index), and psychological well-being (Brief Symptom Inventory Depression/Anxiety, Impact of Events Scale-Revised, CR-38 Body Image). RESULTS: Women enrolled in the study intervention were on average 55 years old, predominantly Caucasian (79%), married (57%), and a median of 4 years postprimary treatment. For those reporting sexual activity at baseline (N=41), sexual dysfunction was associated with a range of specific measures of psychological well-being, all in the hypothesized direction. The Sexual/Relationship Satisfaction subscale was associated with all measures of psychological well-being (r=-0.45 to -0.70, all P<0.01). Body image, anxiety, and cancer-specific posttraumatic distress were notable in their association with subscales of sexual functioning, while a global QOL measure was largely unrelated. CONCLUSIONS: For sexually active female rectal and anal cancer survivors enrolled in a sexual health intervention, sexual dysfunction was significantly and consistently associated with specific measures of psychological well-being, most notably Sexual/Relationship Satisfaction. These results suggest that sexual functioning may require focused assessment by providers, beyond broad QOL assessments, and that attention to Sexual/Relationship Satisfaction may be critical in the development and implementation of interventions for this cohort of patients.