Biomechanical Threshold Values for Identifying Clinically Significant Knee-Related Symptoms Six Months Following Anterior Cruciate Ligament Reconstruction.

CONTEXT: Slower habitual walking speed and aberrant gait biomechanics are linked to clinically significant knee-related symptoms and articular cartilage composition changes linked to posttraumatic osteoarthritis (PTOA) following anterior cruciate ligament reconstruction (ACLR). OBJECTIVE: To determine specific gait biomechanical variables that can accurately identify individuals with clinically significant knee-related symptoms post-ACLR, and the corresponding threshold values, sensitivity, specificity, and odds ratios for each biomechanical variable. DESIGN: Cross-sectional analysis. SETTING: Laboratory. PATIENTS OR OTHER PARTICIPANTS: Seventy-one individuals (n=38 female; age=21±4 years; height=1.76±0.11 m; mass=75.38±13.79 kg) who were 6 months post-primary unilateral ACLR (6.2±0.4 months). MAIN OUTCOME MEASURES: 3D motion capture of 5 overground walking trials was used to calculate discrete gait biomechanical variables of interest during stance phase (1st and 2nd peak vertical ground reaction force [vGRF]; midstance minimum vGRF; peak internal knee abduction and extension moments; and peak knee flexion angle), along with habitual walking speed. Knee Injury and Osteoarthritis Outcome Scores (KOOS) was used to dichotomize patients as symptomatic (n=51) or asymptomatic (n=20) using the Englund et al. 2003 KOOS guidelines for defining clinically significant knee-related symptoms. Separate receiver operating characteristic (ROC) curves and respective areas under the curve (AUC) were used to evaluate the capability of each biomechanical variable of interest for identifying individuals with clinically significant knee-related symptoms. RESULTS: Habitual walking speed (AUC=0.66), vGRF at midstance (AUC=0.69), and 2nd peak vGRF (AUC=0.76), demonstrated low-to-moderate accuracy for identifying individuals with clinically significant knee-related symptoms. Individuals who exhibited habitual walking speeds ≤1.27 m/s, midstance vGRF ≥0.82 BW, and 2nd peak vGRF ≤1.11 BW, demonstrated 3.13, 6.36, and 9.57 times higher odds of experiencing clinically significant knee-related symptoms, respectively. CONCLUSIONS: Critical thresholds for gait variables may be utilized to identify individuals with increased odds of clinically significant knee-related symptoms and potential targets for future interventions.

Modifying loading during gait leads to biochemical changes in serum cartilage oligomeric matrix protein concentrations in a subgroup of individuals with anterior cruciate ligament reconstruction.

PURPOSE: Strong observational evidence has linked changes in limb loading during walking following anterior cruciate ligament reconstruction (ACLR) to posttraumatic osteoarthritis (PTOA). It remains unknown if manipulating peak loading influences joint tissue biochemistry. Thus, the purpose of this study is to determine whether manipulating peak vertical ground reaction force (vGRF) during gait influences changes in serum cartilage oligomeric matrix protein (sCOMP) concentrations in ACLR participants. METHODS: Forty ACLR individuals participated in this randomized crossover study (48% female, age = 21.0 ± 4.4 years, BMI = 24.6 ± 3.1). Participants attended four sessions, wherein they completed one of four biofeedback conditions (habitual loading (no biofeedback), high loading (5% increase in vGRF), low loading (5% decrease in vGRF), and symmetrical loading (between-limb symmetry in vGRF)) while walking on a treadmill for 3000 steps. Serum was collected before (baseline), immediately (acute post), 1 h (1 h post), and 3.5 h (3.5 h post) following each condition. A comprehensive general linear mixed model was constructed to address the differences in sCOMP across all conditions and timepoints in all participants and a subgroup of sCOMP Increasers. RESULTS: No sCOMP differences were found across the entire cohort. In the sCOMP Increasers, a significant time × condition interaction was found (F9,206 = 2.6, p = 0.009). sCOMP was lower during high loading than low loading (p = 0.009) acutely (acute post). At 3.5 h post, sCOMP was higher during habitual loading than symmetrical loading (p = 0.001). CONCLUSION: These data suggest that manipulating lower limb loading in ACLR patients who habitually exhibit an acute increase in sCOMP following walking results in improved biochemical changes linked to cartilage health. Key Points • This study assesses the mechanistic link between lower limb load modification and joint tissue biochemistry at acute and delayed timepoints. • Real-time biofeedback provides a paradigm to experimentally assess the mechanistic link between loading and serum biomarkers. • Manipulating peak loading during gait resulted in a metabolic effect of lower sCOMP concentrations in a subgroup of ACLR individuals. • Peak loading modifications may provide an intervention strategy to mitigate the development of PTOA following ACLR.

Practical Guide to Machine Learning and Artificial Intelligence in Surgical Education Research.

This Guide to Statistics and Methods gives an overview of artificial intelligence techniques and tools in surgical education research.

Practical Guide to Experimental and Quasi-Experimental Research in Surgical Education.

This Guide to Statistics and Methods describes the methods and pitfalls of experimental and quasi-experimental study designs in surgical education.

Practical Guide to Assessment Tool Development for Surgical Education Research.

This Guide to Statistics and Methods describes the process of validation and gathering validity evidence for assessment tool development for surgical education research.

Practical Guide to Curricular Development Research.

This Guide to Statistics and Methods provides an overview of performing curricular development research.

Physical Activity Associates with T1rho MRI of Femoral Cartilage After Anterior Cruciate Ligament Reconstruction.

PURPOSE: Less physical activity has been associated with systemic biomarkers of cartilage breakdown after anterior cruciate ligament reconstruction (ACLR). However, previous research lacks analysis of deleterious cartilage compositional changes and objective physical activity after ACLR. The purpose of this study was to determine the association between physical activity quantified via accelerometer-based measures of daily steps and time in moderate-to-vigorous physical activity (MVPA), and T1rho magnetic resonance imaging (MRI) of the femoral articular cartilage, a marker of proteoglycan density in individuals with ACLR. METHODS: Daily steps and MVPA were assessed over 7 d using an accelerometer worn on the hip in 26 individuals between 6 and 12 months after primary unilateral ACLR. Resting T1rho MRI was collected bilaterally, and T1rho MRI interlimb ratios (ILR: ACLR limb/contralateral limb) were calculated for lateral and medial femoral condyle regions of interest. We conducted univariate linear regression analyses to determine associations between T1rho MRI ILRs and daily steps and MVPA with and without controlling for sex. RESULTS: Greater T1rho MRI ILR of the central lateral femoral condyle, indicative of less proteoglycan density in the ACLR limb, was associated with greater time in MVPA ( R2 = 0.178, P = 0.032). Sex-adjusted models showed significant interaction terms between daily steps and sex in the anterior ( P = 0.025), central ( P = 0.002), and posterior ( P = 0.002) medial femoral condyle. CONCLUSIONS: Lesser physical activity may be a risk factor for maintaining cartilage health after ACLR; additionally, the relationship between physical activity and cartilage health may be different between males and females.

The Use of Medical Crowdfunding to Mitigate the Personal Costs of Serious Chronic Illness: Scoping Review.

BACKGROUND: Persons diagnosed with serious chronic illnesses and their caretakers experience multiple types of financial costs that strain their income and generate financial distress. Many turn to medical crowdfunding (MCF) to mitigate the harms of these costs on their health and quality of life. OBJECTIVE: This scoping review aims to summarize the research on MCF for persons diagnosed with serious chronic illness regarding study designs and methods; the responsible conduct of research practices; and study foci as they relate to stress, stress appraisals, and the coping processes. METHODS: This review was conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Eligible studies were conducted in countries designated as high income by the World Bank and focused on beneficiaries diagnosed with serious chronic illness. The findings of the included studies were summarized as they related to the key concepts in a conceptual framework derived from an established stress, appraisal, and coping framework and a conceptual model of financial toxicity in pediatric oncology. RESULTS: Overall, 26 studies were eligible for inclusion in the review. The main findings included a lack of integration of qualitative and quantitative approaches and the inconsistent reporting of the responsible conduct of research practices. The included studies focused on financial stressors that contributed to financial burden, such as out-of-pocket payments of medical bills, basic living expenses, medical travel expenses, and lost income owing to illness-related work disruptions. Few studies addressed stress appraisals as threatening or the adequacy of available financial resources. When mentioned, appraisals related to the global financial struggle during the COVID-19 pandemic or the capacity of social network members to donate funds. The consequences of MCF included the receipt of 3 forms of social support (tangible, informational, and emotional), privacy loss, embarrassment, and the propagation of scientifically unsupported information. Studies found that friends and family tended to manage MCF campaigns. Although most of the studies (21/26, 81%) focused on monetary outcomes, a few (5/26, 19%) concentrated on peoples' experiences with MCF. CONCLUSIONS: The identified methodological gaps highlight the need for more robust and reproducible approaches to using the copious data available on public MCF platforms. The integration of quantitative and qualitative methods will allow for nuanced explorations of the MCF experience. A more consistent elaboration of strategies to promote the responsible conduct of research is warranted to minimize risk to populations that are vulnerable and express concerns regarding the loss of privacy. Finally, an examination of the unanticipated consequences of MCF is critical for the development of future interventions to optimize existing supports while providing needed supports, financial and nonfinancial, that are lacking.

Black American women's attitudes toward seeking mental health services and use of mobile technology to support the management of anxiety.

Objectives: This study aimed to understand Black American women's attitudes toward seeking mental health services and using mobile technology to receive support for managing anxiety. Methods: A self-administered web-based questionnaire was launched in October 2019 and closed in January 2020. Women who identified as Black/African American were eligible to participate. The survey consisted of approximately 70 questions and covered topics such as, attitudes toward seeking professional psychological help, acceptability of using a mobile phone to receive mental health care, and screening for anxiety. Results: The findings of the study (N = 395) showed that younger Black women were more likely to have greater severity of anxiety than their older counterparts. Respondents were most comfortable with the use of a voice call or video call to communicate with a professional to receive support to manage anxiety in comparison to text messaging or mobile app. Younger age, higher income, and greater scores for psychological openness and help-seeking propensity increased odds of indicating agreement with using mobile technology to communicate with a professional. Black women in the Southern region of the United States had twice the odds of agreeing to the use of mobile apps than women in the Midwest and Northeast regions. Discussion: Black American women, in general, have favorable views toward the use of mobile technology to receive support to manage anxiety. Conclusion: Preferences and cultural appropriateness of resources should be assessed on an individual basis to increase likelihood of adoption and engagement with digital mental health interventions for management of anxiety.

Precision Medicine-Based Machine Learning Analyses to Explore Optimal Exercise Therapies for Individuals With Knee Osteoarthritis: Random Forest-Informed Tree-Based Learning.

OBJECTIVE: We applied a precision medicine-based machine learning approach to discover underlying patient characteristics associated with differential improvement in knee osteoarthritis symptoms following standard physical therapy (PT), internet-based exercise training (IBET), and a usual care/wait list control condition. METHODS: Participants (n = 303) were from the Physical Therapy vs Internet-Based Training for Patients with Knee Osteoarthritis trial. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12-month follow-up. Random forest-informed tree-based learning was applied to identify patient characteristics that were critical to improving outcomes, and patients with those features were grouped. RESULTS: Age, BMI, and Brief Fear of Movement (BFOM) score, all at baseline, were identified as characteristics that effectively divided participants, creating 6 subgroups. Assigning treatments according to these models, compared to assigning a single best treatment to all patients, resulted in greater improvements of the average WOMAC at 12 months (P = 0.01). Key patterns were that IBET was the optimal treatment for patients of younger age and low BFOM, whereas PT was the optimal treatment for patients of older age, high BFOM, and BMI (kg/m2) between 26.3 and 37.2. CONCLUSION: These results suggest that easily assessed patient characteristics including age, fear of movement, and BMI could be used to guide patients toward either home-based exercise or PT, though additional studies are needed to confirm these findings. (ClinicalTrials.gov: NCT02312713).

Attitudes Toward Seeking Mental Health Services and Mobile Technology to Support the Management of Depression Among Black American Women: Cross-Sectional Survey Study.

BACKGROUND: Depression is a common mental health condition among Black American women. Many factors may contribute to the development of depressive symptoms, such as gender and racial discrimination, financial strain, chronic health conditions, and caregiving responsibilities. Barriers such as the stigmatization of mental illness, less access to treatment, the lack of or inadequate health insurance, mistrust of providers, and limited health literacy prevent marginalized populations from seeking care. Previous literature has shown that mobile health interventions are effective and can increase access to mental health services and resources. OBJECTIVE: We aimed to understand the attitudes and perceptions of Black women toward using mental health services and determine the acceptability and concerns of using mobile technology (ie, voice call, video call, SMS text messaging, and mobile app) to support the management of depression. METHODS: We launched a self-administered web-based questionnaire in October 2019 and closed it in January 2020. Women (aged ≥18 years) who identify as Black or African American or multiracial (defined as Black or African American and another race) were eligible to participate. The survey consisted of approximately 70 questions and included topics such as attitudes toward seeking professional psychological help, the acceptability of using a mobile phone to receive mental health care, and screening for depression. RESULTS: The findings (n=395) showed that younger Black women were more likely to have greater severity of depression than their older counterparts. The results also revealed that Black women have favorable views toward seeking mental health services. Respondents were the most comfortable with the use of voice calls or video calls to communicate with a professional to receive support for managing depression in comparison with SMS text messaging or mobile apps. The results revealed that higher help-seeking propensity increased the odds of indicating agreement with the use of voice calls and video calls to communicate with a professional to receive support for managing depression by 27% and 38%, respectively. However, no statistically significant odds ratios (all P>.05) were found between help-seeking propensity and respondents' agreement to use mobile apps or SMS text messaging. Moderate to severe depression severity increased the odds of using mobile apps to communicate with a professional to receive support for managing depression by 43%; however, no statistically significant odds ratios existed for the other modalities. Privacy and confidentiality, communication issues (eg, misinterpreting text), and the impersonal feeling of communicating by mobile phone (eg, SMS text messaging) were the primary concerns. CONCLUSIONS: Black American women, in general, have favorable views toward seeking mental health services and are comfortable with the use of mobile technology to receive support for managing depression. Future work should address the issues of access and consider the preferences and cultural appropriateness of the resources provided.

Delayed cartilage oligomeric matrix protein response to loading is associated with femoral cartilage composition post-ACLR.

PURPOSE: To determine associations between immediate and delayed response of serum cartilage oligomeric matrix protein (sCOMP) to loading (i.e., 3000 walking steps) and femoral cartilage interlimb T1ρ relaxation times in individual's post-anterior cruciate ligament reconstruction (ACLR). METHODS: This cross-sectional study included 20 individuals 6-12 months following primary ACLR (65% female, 20.5 ± 4.0 years old, 24.9 ± 3.0 kg/m2, 7.3 ± 1.5 months post-ACLR). Serum samples were collected prior to, immediately following, and 3.5 h following walking 3000 steps on a treadmill at habitual walking speed. sCOMP concentrations were processed using enzyme-linked immunosorbent assays. Immediate and delayed absolute sCOMP responses to loading were evaluated immediately and 3.5 h post-walking, respectively. Participants underwent bilateral magnetic resonance imaging with T1ρ sequences to calculate resting femoral cartilage interlimb T1ρ relaxation time ratios between limbs (i.e., ACLR/Uninjured limb). Linear regression models were fitted to determine associations between sCOMP response to loading and femoral cartilage T1ρ outcomes controlling for pre-loading sCOMP concentrations. RESULTS: Greater increases in delayed sCOMP response to loading were associated with greater lateral (∆R2 = 0.29, p = 0.02) but not medial (∆R2 < 0.01, p = 0.99) femoral cartilage interlimb T1ρ ratios. Associations between immediate sCOMP response to loading with femoral cartilage interlimb T1ρ ratios were weak and non-significant (∆R2 range = 0.02-0.09, p range = 0.21-0.58). CONCLUSION: Greater delayed sCOMP response to loading, a biomarker of cartilage breakdown, is associated with worse lateral femoral cartilage composition in the ACLR limb compared to the uninjured limb. Delayed sCOMP response to loading may be a more indicative metabolic indicator linked to deleterious changes in composition than immediate sCOMP response.

Practical Guide to Ethical Considerations in Clinical Trials in Surgery.

This Guide to Statistics and Methods provides an overview of current ethical considerations and standards for clinical research.

Practical Guide to Budgeting and Funding a Clinical Trial in Surgery.

This Guide to Statistics and Methods outlines the considerations when determining a budget for a clinical trial in preparation for submitting applications to various funding agencies.

Does Participation in Food Benefit Programs Reduce the Risk for Depressive Symptoms?

BACKGROUND: Food insecurity affects 15 million households in the United States and is associated with negative physical and mental health outcomes including Major Depressive Disorder. Governmental public assistance or food benefit programs including the Supplemental Nutrition Assistance Program (SNAP) and Women, Infants, and Children (WIC) are social intervention services that attempt to minimize food insecurity for low-income households. There is little consensus regarding the effects of food benefit participation on reducing risk of depressive symptoms. AIM: This study aims to explore the association between household food insecurity and food benefit participation (SNAP or WIC) on risk for depressive symptoms using nationally representative samples from the Center for Disease and Control and Prevention Nutritional Health and Nutrition Examination Survey 2013-2014 and 2015-2016 cohorts. We hypothesize that food insecurity is associated with increased risk of depressive symptoms and food benefit participation with reduced risk. METHOD: Cross-sectional analyses were conducted using survey-weighted logistic regression to explore the relationship between food insecurity, food benefit participation, and the risk of depressive symptoms controlling for relevant income and sociodemographic variables. RESULTS: When controlling for sociodemographic variables, food benefit participation did not reduce the risk of depressive symptoms, while high levels of food insecurity were associated with elevated risk. CONCLUSIONS: High levels of food insecurity are associated with elevated risk of depressive symptoms. Nurses and public health professionals can address food security needs through increased knowledge of referral and eligibility requirements. Implications on clinical practice, policy, and future directions for research are discussed.

Improvement Trajectories in Patient-Reported Outcomes Between Males and Females After Anterior Cruciate Ligament Reconstruction.

CONTEXT: Patient-reported outcomes (PROs) are used to track recovery and inform clinical decision-making after anterior cruciate ligament reconstruction (ACLR). Whether sex influences the trajectory of improvements in PROs over time post-ACLR remains unclear. OBJECTIVES: To (1) examine the effect of sex on the association between months post-ACLR and Knee injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) scores in individuals with ACLR and (2) assess sex differences in the KOOS QOL score at selected timepoints post-ACLR. DESIGN: Cross-sectional study. SETTING: Laboratory. PATIENTS OR OTHER PARTICIPANTS: A total of 133 females (20± 3 years) and 85 males (22 ± 4 years) within 6 to 60 months of primary, unilateral ACLR. MAIN OUTCOME MEASURE(S): The KOOS QOL was completed at a single follow-up timepoint post-ACLR. A multivariate linear regression model was calculated to assess the interaction of sex on the association between months post-ACLR and KOOS QOL score. Sex-specific linear regression models were then used to predict KOOS QOL estimated marginal means at each clinical timepoint (6, 12, 24, 36, 48, and 60 months post-ACLR) and compare the sexes. RESULTS: In the primary model (R2 = 0.16, P < .0001), a significant interaction existed between sex and time post-ACLR (ß = -0.46, P < .01). Greater months post-ACLR were associated with better KOOS QOL scores for males (R2 = 0.29, ß = 0.69, P < .001); months post-ACLR was a weaker predictor of KOOS QOL scores for females (R2 = 0.04, ß = 0.23, P < .02). Estimated marginal means for KOOS QOL scores were greater for males than females at 36 months (t210 = 2.76, P < .01), 48 months (t210 = 3.02, P < .01), and 60 months (t210 = 3.09, P = .02) post-ACLR. CONCLUSIONS: Males exhibited PRO improvement post-ACLR as the months post-ACLR increased, whereas females did not demonstrate the same magnitude of linear increase in KOOS QOL score. Females may require extended intervention to improve clinical outcomes post-ACLR and address a plateau in QOL score.

A Visual Case-Oriented Analysis of Stress-Related Symptoms in Caregivers of Allogeneic Bone Marrow Transplantation Recipients.

OBJECTIVES: To describe trends in caregiver stress and stress-related symptoms (anxiety, depression, fatigue, and sleep disturbance) across 12 weeks post-transplantation. SAMPLE & SETTING: 11 caregivers were recruited from a National Cancer Institute-designated comprehensive cancer center's bone marrow transplantation (BMT) outpatient clinic in the southeastern United States. METHODS & VARIABLES: A visual case-oriented analysis was conducted on data from 11 caregivers' weekly self-reported data to identify trends after allogeneic BMT. RESULTS: The authors identified three primary trends as follows: U-shaped (highest symptoms at start of transplantation and end of study; n = 3), negatively sloped (highest symptoms at beginning of transplantation and decreasing over time; n = 2), and V-shaped predischarge (highest symptoms at start of transplantation and right before discharge home; n = 4). Two caregivers did not have postdischarge data because of patient death prior to study completion. IMPLICATIONS FOR NURSING: Caregivers may benefit from additional support to manage their stress-related symptoms at the start of transplantation and just before discharge.

Immune-related adverse events in patients with pre-existing autoimmune rheumatologic disease on immune checkpoint inhibitor therapy.

INTRODUCTION: Immune checkpoint inhibitors (ICIs) enhance the immune system's ability to target and destroy cancer cells, but this non-specific immune overactivation can result in immune-related adverse events (irAEs). Patients with underlying autoimmune diseases were excluded from the original ICI clinical trials because of the theoretical risk of irAEs. This study aimed to evaluate the risk of irAEs in patients with pre-existing rheumatologic diseases on ICIs, impact of anti-rheumatic therapy on irAEs, and malignancy outcomes. METHODS: We performed a retrospective chart review of patients with a pre-existing rheumatologic diagnosis receiving ICIs at the University of North Carolina from 2014 to 2019. Risk differences (RD) and asymptotic 95% confidence intervals (95% CIs) using a continuity correction along with odds ratios (OR) and exact 95% CIs were produced between pre-specified risk factors and flares of the underlying rheumatologic disease and/or irAEs. Kaplan-Meier survival estimates for time to unfavorable cancer response between subsets of patients were compared using the log-rank test. RESULTS: We identified 45 patients receiving an ICI with an underlying rheumatologic diagnosis, including 22 with rheumatoid arthritis (RA). Overall, 13 patients (29%) had a flare of their autoimmune disease, 20 patients (44%) had a new-onset irAE, and 27 (60%) had either a flare or new-onset irAE. Patients with RA had higher risk of flares compared to those with other rheumatologic disorders (45% vs 13%, RD 32%, 95% CI 2.0-56.8); all RA flares were ≤ grade 2 and treated in the outpatient setting. Concurrent treatment of the rheumatologic disease at the start of ICI therapy was not associated with a reduced risk of flare (OR 0.86, 95% CI 0.19-3.76) or new onset irAE (OR 3.21, 95% CI 0.83-13.6) compared to those not on anti-rheumatic medications. Anti-rheumatic therapy did not impact time to unfavorable malignancy outcome (p = 0.52). CONCLUSION: The majority of our study cohort experienced a flare or new onset irAE with ICI treatment. Treatment with anti-rheumatic therapy did not prevent disease flares or new onset irAEs, but did not negatively impact malignancy outcomes. Research is needed to determine safe anti-rheumatic therapy options to prevent flares and irAEs that do not interfere with malignancy outcomes.

Practical Guide to Recruitment of Participants for Surgical Clinical Trials.

This Guide to Statistics and Methods proposes guidance for clinical trial recruitment to improve diverse population representation and overall generalizability.