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 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.

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.

Physical Activity Intervention Characteristics and Effects on Behavioral and Health-Related Outcomes Among Adolescents and Young Adults Living with and Beyond Cancer: A Systematic Review.

Participation in physical activity (PA) during and after cancer treatment is safe and beneficial in the adolescent and young adult (AYA) cancer population. PA can positively impact health-related outcomes; however, participation remains low. This systematic review aims to describe PA intervention characteristics and outcomes in AYA survivors of cancer (AYASCa). This review followed Preferred Reporting Index for Systematic Reviews and Meta Analyses (PRISMA) guidelines and was registered with Prospero (CRD42022365661). PubMed, CINAHL, and Scopus databases were searched for randomized control trials (RCTs) and pre/post-test studies without a control group through December 31, 2022. Data included: participant demographics, PA intervention characteristics, and health-related outcomes. Studies were assessed using the National Institute of Health Critical Appraisal Tools, and findings were synthesized to identify common characteristics of PA interventions and outcomes. Twenty-three studies were included: 15 RCTs and 8 pre/post-test studies. Heterogeneity existed across design, sample demographics, intervention timing, and observed outcomes. The most common characteristics of PA interventions were supervision of PA, wearable device use, tailored/individualized PA prescriptions, and goal setting. PA interventions positively affected health-related outcomes, with 21 studies reporting statistically significant findings. Implementing personalized PA prescriptions, utilizing wearable devices, and incorporating goal setting as characteristics in PA interventions hold potential benefits for AYASCa, leading to improved outcomes. Still, additional research is needed to explore interventions that utilize these PA characteristics and determine which ones are most effective for AYASCa. By further investigating and identifying optimal PA characteristics, interventions can be better tailored to meet this population's specific needs and preferences, ultimately enhancing their overall well-being and recovery.

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.

Changes in biomechanics, strength, physical function, and daily steps after extended-release corticosteroid injections in knee osteoarthritis: a responder analysis.

INTRODUCTION/OBJECTIVE: To determine changes in gait biomechanics, quadricep strength, physical function, and daily steps after an extended-release corticosteroid knee injection at 4 and 8 weeks post-injection in individuals with knee osteoarthritis as well as between responders and non-responders based on changes in self-reported knee function. METHOD: The single-arm, clinical trial included three study visits (baseline, 4 weeks, and 8 weeks post-injection), where participants received an extended-release corticosteroid injection following the baseline visit. Time-normalized vertical ground reaction force (vGRF), knee flexion angle (KFA), knee abduction moment (KAM), and knee extension moment (KEM) waveforms throughout stance were collected during gait biomechanical assessments. Participants also completed quadricep strength, physical function (chair-stand, stair-climb, 20-m fast-paced walk) testing, and free-living daily step assessment for 7 days following each visit. RESULTS: All participants demonstrated increased KFA excursion (i.e., greater knee extension angle at heel strike and KFA at toe-off), increased KEM during early stance, improved physical function (all p < 0.001), and increased quadricep strength at 4 and 8 weeks. KAM increased throughout most of stance at 4 and 8 weeks post-injection (p < 0.001) but appears to be driven by gait changes in non-responders. Non-responders demonstrated lesser vGRF during late stance and lesser KEM and KFA throughout stance compared to responders at baseline. CONCLUSIONS: Extended-release corticosteroid injections demonstrated short-term improvements in gait biomechanics, quadricep strength, and physical function for up to 4 weeks. However, non-responders demonstrated gait biomechanics associated with osteoarthritis progression prior to the corticosteroid injection, suggesting that non-responders demonstrate more deleterious gait biomechanics prior to corticosteroid injection. Key Points • Individuals with knee osteoarthritis who were treated with extended-release corticosteroid injections demonstrated improvements in gait biomechanics and physical function for 8 weeks. • Individuals with knee osteoarthritis, who walked with aberrant walking biomechanics before treatment, failed to respond to extended-release corticosteroid treatment. • Future research should determine the mechanisms contributing to the short-term changes in gait biomechanics and physical function such as reduced inflammation.

Perspectives of caregivers of older adults with acute myeloid leukemia during initial hypomethylating agents and venetoclax chemotherapy.

BACKGROUND: Older adults with AML commonly receive a hypomethylating agent (HMA) as first-line therapy. The addition of venetoclax (VEN) to HMAs has been shown to improve remission rates and overall survival. The use of combination therapy (HMA + VEN) requires frequent follow-up, results in longer infusion times, and likely increases caregiver responsibility at home. We describe experiences of informal caregivers (family/friends) providing care to older adults with AML receiving HMA + VEN. METHODS: Fourteen caregivers of older adults with AML receiving HMA + VEN (September 2020 to September 2021) were recruited as part of a control group of an ongoing NIH-funded clinical trial. Semi-structured interviews were conducted to gain initial insight into caregiver experiences at the start of HMA + VEN treatment. Two researchers analyzed the data using thematic content analysis. Data saturation occurred when no new themes were found in subsequent interviews, but all interviews were coded and synthesized. RESULTS: Of the 14 caregivers interviewed, the majority were spouses (n = 10), female (n = 13), and aged 45 to 83 (median age 65). We identified five themes: (1) the impact of an AML diagnosis in older adulthood, (2) care recipient condition changes, (3) perspectives of caregiving roles and tasks, (4) factors influencing caregiving experiences, and (5) support system roles. CONCLUSIONS AND IMPLICATIONS: Caregivers for older adults with AML report a range of experiences navigating health systems, caregiving responsibilities, and resource needs. The risk for caregiver burden and unmet needs should be addressed to improve caregivers' abilities to provide care.

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.

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.