Objective Performance Goals Based on a Systematic Review and Meta-Analysis of Clinical Outcomes for Bare-Metal Stents and Percutaneous Transluminal Angioplasty for Hemodialysis-Related Central Venous Obstruction.

PURPOSE: To use safety and efficacy outcomes following treatment with percutaneous transluminal angioplasty (PTA) and/or stent placement for thoracic central venous obstruction in hemodialysis-dependent patients to establish objective performance goals (OPGs). METHODS: A systematic literature review and meta-analysis were conducted for articles published between January 1, 2000, and August 31, 2021. Efficacy outcomes included primary patency rates at 6 and 12 months, and safety outcomes included adverse events (AEs) categorized as access loss, procedure-related AEs, and serious AEs (SAEs). OPGs were derived from the upper and lower bounds of the 95% confidence intervals for primary patency and SAE rates. RESULTS: Of 66 articles reviewed, 17 met the inclusion criteria (PTA, n = 4; stent placement, n = 5; PTA/stent, n = 8). The 6- and 12-month primary patency rates for PTA were 50.9% and 36.7%, respectively. Based on these findings, the proposed 6- and 12-month primary patency OPGs identifying superiority against PTA were 66.5% and 52.6%, respectively, and those for noninferiority were 39.0% and 25.7%, respectively. For stent placement, the 6- and 12-month primary patency rates were 69.7% and 47.9%, respectively. The proposed 6- and 12-month primary patency OPGs identifying superiority were 82.1% and 64.1%, respectively, and those for noninferiority were 59.3% and 35.8%, respectively. SAE rates for PTA and stent placement were 3.8% and 8.1%, respectively. Proposed safety OPGs for noninferiority versus superiority for PTA and stent placement were 10.1% versus 1.4% and 13.6% versus 4.8%, respectively. CONCLUSION: The OPGs derived from real-world studies of PTA and stent placement may serve as a benchmark for future interventions indicated for this patient population.

An Exploration of the Use and Impact of Preventive Measures on Skin Cancer.

Background: Skin cancer is the most common form of cancer, and both clinical and epidemiological data link cumulative solar dosages and the number of sunburns to skin cancer. Each year, more than 5.4 million new cases of skin cancer are diagnosed, incurring a significant health and financial burden. Recommended preventive measures for skin cancer include the use of sunscreen, sun avoidance, and protective clothing. This study used a national database to examine the association of preventive measures with the prevalence of skin cancer, specifically analyzing the preventive measures of sunscreen use, staying in the shade, and wearing long-sleeved shirts. The second aim was to determine which characteristics, if any, correlated with using prevention measures. Methods: This study analyzed data from the National Health and Nutritional Examination Survey 2015−2016 cycle to examine the association of three preventive measures (using sunscreen, staying in the shade, and wearing long-sleeved shirts) with skin cancer. Logistic regression and chi-square tests were utilized to examine the relationship between skin cancer and these prevention methods. Results: Sunscreen use (OR = 3.752; p < 0.05) was statistically associated with a lower prevalence of skin cancer, while wearing long-sleeved shirts (OR = 6.911; p = 0.064) and staying in the shade (OR = 0.646; p = 0.481) did not emerge as factors significantly associated with a lower prevalence after controlling for gender, race/ethnicity, marital status, income, health insurance, and general health. Additionally, men and individuals of color were less likely to use sunscreen. Conclusion: Sunscreen use was associated with a lower prevalence of skin cancer, while wearing long-sleeved shirts and staying in the shade was not significantly linked to lower rates of skin cancer, suggesting that these measures may not be as effective as sunscreen for preventing skin cancer. Men and individuals of color were significantly less likely to use sunscreen. These findings can help guide future education efforts and research regarding skin cancer prevention and suggest the need to develop male-oriented programs to mitigate the gender disparity in employing sun-protection measures.

Using machine learning to identify factors associated with practice location of the healthcare workforce.

INTRODUCTION: Past studies examined factors associated with rural practice, but none employed newer machine learning (ML) methods to explore potential predictors. The primary aim of this study was to identify factors related to practice in a rural area. Secondary aims were to capture a more precise understanding of the demographic characteristics of the healthcare professions workforce in Utah (USA) and to assess the viability of ML as a predictive tool. METHODS: This study incorporated four datasets - the 2017 dental workforce, the 2016 physician workforce, the 2014 nursing workforce and the 2017 pharmacy workforce - collected by the Utah Medical Education Council. Supervised ML techniques were used to identify factors associated with practice location, the outcome variable of interest. RESULTS: The study sample consisted of 11 259 healthcare professionals with an average age of 46.6 years, of which 36.6% were males and 94.5% Caucasian. Four ML methods were applied to assess model performance by comparing accuracy, sensitivity, specificity and area under the receiver operating characteristic (ROC) curve. Of the methods used, support vector machine performed the best (accuracy 99.7%, precision 100%, sensitivity 100%, specificity 99.4% and ROC 0.997). The models identified income and rural upbringing as the top factors associated with rural practice. CONCLUSION: By far, income emerged as the most important factor associated with rural practice, suggesting that attractive income offers might help rural communities address health professional shortages. Rural upbringing was the next most important predictive factor, validating and updating earlier research. The performance of the ML algorithms suggests their usefulness as a tool to model other databases for individualized prediction.

A population-based study of scoliosis among males diagnosed with a dystrophinopathy identified by the Muscular Dystrophy Surveillance, Tracking, and Research Network (MD STARnet).

INTRODUCTION/AIMS: Scoliosis is a common comorbidity among individuals diagnosed with a dystrophinopathy. We examined associations between clinical predictors and scoliosis in childhood-onset dystrophinopathy. METHODS: The progression and treatment of scoliosis were obtained from data collected by the US population-based Muscular Dystrophy Surveillance, Tracking, and Research Network. Associations between loss of independent ambulation (LoA) and corticosteroid use and scoliosis outcomes (ages at or exceeding Cobb angle thresholds [10°, 20°, 30°]; surgery) were estimated using Kaplan-Meier curve estimation and extended Cox regression modeling. RESULTS: We analyzed curvature data for 513 of 1054 individuals ascertained. Overall, approximately one-half had at least one radiograph and one-quarter had a curvature of at least 20°. The average maximum curvature was 25.0° (SD = 21.5°) among all individuals and 42.8° (SD = 18.8°) among those recommended for surgery. Higher adjusted hazards ratio of curvature (aHR(curvature) [95% confidence interval]) were found among individuals with LoA compared to those without LoA (aHR(10)  = 6.2 [4.4, 8.7], aHR(20)  = 15.3 [7.4, 31.7], aHR(30)  = 31.6 [7.7, 128.9]), among individuals who did not use corticosteroids compared to those who did (aHR(10)  = 1.2 [0.9, 1.7], aHR(20)  = 1.8 [1.1, 2.7], aHR(30)  = 2.3 [1.3, 4.0]), and among non-ambulatory individuals who used corticosteroids after LoA compared to those who did not (aHR(10)  = 1.8 [1.2, 2.8], aHR(20)  = 1.6 [1.0, 2.6], aHR(30)  = 3.6 [1.6, 7.9]). Scoliosis surgery among individuals with LoA who did not use corticosteroids was more than double compared to those who used (aHR = 2.3 [1.3, 4.2]). DISCUSSION: Our retrospective observational study suggests corticosteroids may delay spinal curvature progression and need for scoliosis surgery. Continuing corticosteroids after LoA also showed potential benefits of delaying curvature progression, additional studies are needed to confirm this finding or address the magnitude of benefit.

Health Disparities Associated with Females Reporting Human Papillomavirus Infection in the United States.

Few studies provide detailed findings about the health disparities of women being told by a physician whether they have ever had a human papillomavirus (HPV) infection. This study sought to characterize the prevalence and characteristics associated with women age 18 to 59 years in the United States who report being told they were infected with HPV. This study used data from the National Health and Nutritional Examination Survey. Descriptive statistics were computed on study variables and multiple logistic regression analyses were conducted to explore the association of the study variables with the outcome variable. Sampling weights were applied to produce national estimates of prevalence. The sample consisted of 1,669 females, representative of 75,107,170 females in the United States population. Around 11.5% reported being told that they had an HPV infection, of which 60.9% were White, and 82.9% were born in the United States. White women are 2.0 times more likely to be told they have HPV than Asian women and 2.8 times more likely than Black women. United States-born women were 2.1 times more likely told they had an HPV infection than those foreign born. This study found that among U.S. women, less than 12% reported ever having been told they have had an HPV infection. Epidemiologic findings suggest gaps between ever being told of a previous infection and being diagnosed with a clinically relevant HPV infection. Despite epidemiologic data indicating higher HPV prevalence among those less educated and women of color, these groups were less likely to report ever being told they have an HPV infection than White women, and those with a college degree suggesting communication gaps among these subgroups about HPV infection that might exist. Strategies to address potential gaps in communication among these subgroups can potentially reduce the economic burden and health disparities related to HPV infection.

Artificial intelligence in dentistry: Harnessing big data to predict oral cancer survival.

BACKGROUND: Oral cancer is the sixth most prevalent cancer worldwide. Public knowledge in oral cancer risk factors and survival is limited. AIM: To come up with machine learning (ML) algorithms to predict the length of survival for individuals diagnosed with oral cancer, and to explore the most important factors that were responsible for shortening or lengthening oral cancer survival. METHODS: We used the Surveillance, Epidemiology, and End Results database from the years 1975 to 2016 that consisted of a total of 257880 cases and 94 variables. Four ML techniques in the area of artificial intelligence were applied for model training and validation. Model accuracy was evaluated using mean absolute error (MAE), mean squared error (MSE), root mean squared error (RMSE), R 2 and adjusted R 2. RESULTS: The most important factors predictive of oral cancer survival time were age at diagnosis, primary cancer site, tumor size and year of diagnosis. Year of diagnosis referred to the year when the tumor was first diagnosed, implying that individuals with tumors that were diagnosed in the modern era tend to have longer survival than those diagnosed in the past. The extreme gradient boosting ML algorithms showed the best performance, with the MAE equaled to 13.55, MSE 486.55 and RMSE 22.06. CONCLUSION: Using artificial intelligence, we developed a tool that can be used for oral cancer survival prediction and for medical-decision making. The finding relating to the year of diagnosis represented an important new discovery in the literature. The results of this study have implications for cancer prevention and education for the public.

Patient-reported study of the impact of pediatric-onset myotonic dystrophy.

INTRODUCTION: The prevalence and impact of symptoms affecting individuals with pediatric forms of myotonic dystrophy type-1 (DM1) are not well understood. METHODS: Patients from the United States, Canada, and Sweden completed a survey that investigated 20 themes associated with pediatric-onset DM1. Participants reported the prevalence and importance of each theme affecting their lives. Surveys from participants were matched with surveys from their caregivers for additional analysis. RESULTS: The most prevalent symptomatic themes included problems with hands or fingers (79%) and gastrointestinal issues (75%). Problems with urinary/bowel control and gastrointestinal issues were reported to have the greatest impact on patients' lives. Responses from participants and their caregivers had varying levels of agreement among symptomatic themes. DISCUSSION: Many symptoms have meaningful impact on disease burden. The highest levels of agreement between caregivers and individuals with pediatric forms of myotonic dystrophy were found for physical activity themes.

Application of machine learning for diagnostic prediction of root caries.

OBJECTIVE: This study sought to utilise machine learning methods in artificial intelligence to select the most relevant variables in classifying the presence and absence of root caries and to evaluate the model performance. BACKGROUND: Dental caries is one of the most prevalent oral health problems. Artificial intelligence can be used to develop models for identification of root caries risk and to gain valuable insights, but it has not been applied in dentistry. Accurately identifying root caries may guide treatment decisions, leading to better oral health outcomes. METHODS: Data were obtained from the 2015-2016 National Health and Nutrition Examination Survey and were randomly divided into training and test sets. Several supervised machine learning methods were applied to construct a tool that was capable of classifying variables into the presence and absence of root caries. Accuracy, sensitivity, specificity and area under the receiver operating curve were computed. RESULTS: Of the machine learning algorithms developed, support vector machine demonstrated the best performance with an accuracy of 97.1%, precision of 95.1%, sensitivity of 99.6% and specificity of 94.3% for identifying root caries. The area under the curve was 0.997. Age was the feature most strongly associated with root caries. CONCLUSION: The machine learning algorithms developed in this study perform well and allow for clinical implementation and utilisation by dental and nondental professionals. Clinicians are encouraged to adopt the algorithms from this study for early intervention and treatment of root caries for the ageing population of the United States, and for attaining precision dental medicine.

Minimal Clinically Important Difference After Carpal Tunnel Release Using the PROMIS Platform.

PURPOSE: In light of recently-proposed quality measures for carpal tunnel release (CTR), elucidating the minimal clinically important difference (MCID) for selected outcome measures will be important when interpreting treatment responses. Our purpose was to estimate the MCID of the Patient-Reported Outcomes Measurement Information System (PROMIS) instruments and the short Disabilities of the Arm, Shoulder, and Hand (QuickDASH) following CTR. METHODS: Adult patients undergoing isolated unilateral CTR between July 2014 and October 2016 were identified. Outcomes included the PROMIS Upper Extremity (UE) Computer Adaptive Test (CAT), Physical Function (PF) CAT, QuickDASH, and Pain Interference (PI) CAT. For inclusion, pretreatment baseline (within 60 days of surgery) and postoperative (6-90 days) UE or PF CAT scores were required, as well as a response on a 5-point Likert scale to the question "How much relief and/or improvement do you feel you have experienced as a result of your treatment?" The MCID was calculated using SD and minimum detectable change (MDC) distribution methods. RESULTS: In response to the Likert scale question, 88.6% of patients reported improvement at a mean of 14.8 days after surgery. The infrequency of patients reporting no change (5 of 44; 11.4%) precluded calculation of a statistically sound anchor-based MCID value. The MCID values, as calculated using the one-half SD method, were 3.6, 4.6, 10.4, and 3.4 for the UE CAT, PF CAT, QuickDASH, and PI CAT, respectively. CONCLUSIONS: We have calculated MCID values for the UE CAT, PF CAT, QuickDASH, and PI CAT for patients undergoing CTR. Although the small number of patients reporting no change and minimal change after surgery precluded an anchor-based MCID calculation, we report estimates using the one-half SD method for the MCID following CTR. CLINICAL RELEVANCE: These MCID estimates will be helpful when interpreting CTR clinical outcomes and for powering prospective trials.

Validation of a photophobia symptom impact scale.

BACKGROUND: Routine assessment of photophobia in the clinical setting may underestimate the presence and severity of this condition. We aimed to develop and validate a questionnaire to improve evaluation of the impact of photophobia on activities of daily living, and to determine the relationship of this questionnaire to psychophysical assessment of light sensitivity thresholds. METHODS: We developed the 17-item Utah Photophobia Symptom Impact Scale (UPSIS-17) and compared its psychometric properties to the 8-item Korean Photophobia Questionnaire (KUMC-8). Ninety five subjects with or without light sensitivity completed both questionnaires; 72 also completed laboratory-based assessment of light sensitivity thresholds. We used Rasch analysis to evaluate instrument targeting, including internal consistency and reliability. Correlation analysis was used to assess the relationship between questionnaire scores and light sensitivity thresholds. RESULTS: We observed correlation between UPSIS-17 and KUMC-8, r = 0.72 (p < 0.0001). Higher UPSIS-17 scores correlated with light sensitivity thresholds, r = -0.42 (p < 0.0001), whereas KUMC-8 scores did not significantly correlate with light sensitivity thresholds, r = -0.21 (p = 0.072). UPSIS-17 showed better instrument targeting than KUMC-8 on Rasch analysis. Person-item maps allowed for identification of questions that could be removed without affecting questionnaire validity measures. CONCLUSION: This study resulted in a shortened, 12-item questionnaire. The UPSIS-12 retained significant correlation with both the KUMC-8 and light sensitivity thresholds, yielding a simpler tool for symptom assessment, while retaining validity. This expanded tool may be useful in clinical, as well as research settings, for collection of data about disability due to photophobia.

Evaluation of Version 2.0 of the PROMIS Upper Extremity Computer Adaptive Test in Nonshoulder Upper Extremity Patients.

PURPOSE: The Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Computer Adaptive Test (UE CAT) was recently updated to version 2.0 (v2.0). We hypothesized that the PROMIS UE CAT v2.0 would exhibit improved performance characteristics compared with the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) when administered to a nonshoulder upper extremity patient population. METHODS: The UE CAT v2.0, Physical Function (PF) CAT v2.0, and the QuickDASH were each prospectively administered via tablet computer to all patients presenting to a tertiary hand and upper extremity clinic between April 2017 and October 2017. Patient responses were analyzed, and the mean, range, floor and ceiling effect, and correlations between instruments were calculated. RESULTS: Among 825 patients, the mean UE CAT v2.0 score was 38.3 (SD 10.7) with a range of 15 to 61 and interquartile range of 15.4. The UE CAT v2.0 had a strong correlation with the QuickDASH (r = -0.749) and the PF CAT v2.0 (r = 0.719). No patient scored between 56 and 60, indicating a gap in scoring in that range. The UE CAT v2.0 demonstrated a floor effect of 1%, a ceiling effect of 6.9%, and a high internal consistency with a Cronbach alpha of 0.99. CONCLUSIONS: The PROMIS UE CAT v2.0 demonstrated improved ceiling effects, range, and a decreased gap in scoring compared with prior versions. Limitations of the PROMIS UE CAT v2.0 are still present, but updates have led to an incremental improvement over prior versions, demonstrating the ability to influence PROMIS instrument performance through upgrades. CLINICAL RELEVANCE: The updated PROMIS UE CAT v2.0 still demonstrates a ceiling effect and gap in scores at the upper end of the instrument, both of which may limit discrimination between different levels of upper extremity function for high-functioning patients.

Assessing spousal support and health in an aging population: support and strain amidst changing social dynamics.

This study examined the role of relationship quality on physical and psychological health among older adults. It included 2,298 adults aged 50 and older who participated in the Midlife in the US national longitudinal study of health and well-being. We assessed the effect of spousal support and strain on psychological and physical health, controlling for age, education, income, depression levels and prior health. Results indicated that spousal support and strain affected psychological health but not physical health. Despite prior research showing an association between marital quality and physical health, this study did not support the conceptualization that relationship quality measured by spousal support or strain has a direct effect on long-term health in this sample of older adults. This study does not preclude the presence of a mediated or moderated association between relationship quality and physical health. Higher levels of spousal support are associated with positive psychological health among adults over age 50 while spousal strain is associated with negative psychological health. This study supports the premise that relationship quality has an ongoing impact on the psychological health of mature adults, bolstering arguments to include psychological health screening and couples relationship education among health services provided to older adults.

Responsiveness of the PROMIS and FAAM Instruments in Foot and Ankle Orthopedic Population.

BACKGROUND:: Investigating the responsiveness of an instrument is important in order to provide meaningful interpretation of clinical outcomes. This study examined the responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF), the PROMIS Pain Interference (PI), and the Foot and Ankle Ability Measure (FAAM) Sports subscale in an orthopedic sample with foot and ankle ailments. METHODS:: Patients presenting to an orthopedic foot and ankle clinic during the years 2014-2017 responded to the PROMIS and FAAM instruments prior to their clinical appointments. The responsiveness of the PROMIS PF v1.2, PROMIS PI v1.1, and FAAM Sports were assessed using paired samples t test, effect size (ES), and standardized response mean (SRM) at 4 different follow-up points. A total of 785 patients with an average age of 52 years (SD = 17) were included. RESULTS:: The PROMIS PF had ESs of 0.95 to 1.22 across the 4 time points (3, >3, 6, and <6 months) and SRMs of 1.04 to 1.43. The PROMIS PI had ESs of 1.04 to 1.63 and SRMs of 1.17 to 1.23. For the FAAM Sports, the ESs were 1.25 to 1.31 and SRMs were 1.07 to 1.20. The ability to detect changes via paired samples t test provided mixed results. But in general, the patients with improvement had statistically significant improved scores, and the worsening patients had statistically significant worse scores. CONCLUSION:: The PROMIS PF, PROMIS PI, and FAAM Sports were sensitive and responsive to changes in patient-reported health. LEVEL OF EVIDENCE:: Level II, prospective comparative study.

Psychometric evaluation of the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function and Pain Interference Computer Adaptive Test for subacromial impingement syndrome.

BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (CAT) was previously validated for rotator cuff disease and shoulder instability. This study evaluated the psychometric properties of the PROMIS Physical Function (PF) CAT, PROMIS Pain Interference (PI) CAT, and the American Shoulder and Elbow Surgeons (ASES) Shoulder Function Score for subacromial impingement syndrome. METHODS: PROMIS PF CAT, PI CAT, and ASES (Pain, Function, Total) were collected on all visits for 2 surgeons between January 2016 and August 2016. New patients, aged 18 years and older, were selected by International Classification of Diseases code for impingement syndrome of the shoulder. The mean number of questions answered determined efficiency. Person-item maps were created to determine ceiling and floor effects as well as person reliability. Convergent validity was determined by comparison of PROMIS domains to ASES scores with Pearson correlations. RESULTS: For PROMIS PF CAT, the mean number of items answered was 4.54 (range 4-12). The ceiling effect was 1.56%, and the floor effect was 3.13%. The person reliability was 0.94. Pearson correlation coefficients between the PF CAT and ASES were 0.664 (ASES Function), 0.426 (ASES Pain), and 0.649 (ASES Total). For PROMIS PI CAT, the mean number of items answered was 4.27 (range 3-11). The ceiling effect was 4.69%, and the floor effect was 8.33%. The person reliability was 0.92. Pearson correlation coefficients between the PI CAT and ASES were: 0.667 (ASES Function), 0.594 (ASES Pain), and 0.729 (ASES Total). CONCLUSIONS: The psychometric properties of PROMIS PF and PI CATs were favorable for subacromial impingement syndrome.

Responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS), Neck Disability Index (NDI) and Oswestry Disability Index (ODI) instruments in patients with spinal disorders.

BACKGROUND CONTEXT: The Patient-Reported Outcomes Information System (PROMIS) instruments are an important advancement in the use of PROs, but need to be evaluated with longitudinal data to determine whether they are responsive to change in specific clinical populations. PURPOSE: The purpose of this study was to assess the responsiveness of the PROMIS Physical Function (PF), PROMIS Pain Interference (PI), Neck Disability Index (NDI), and the Oswestry Disability Index (ODI). STUDY DESIGN/SETTING: This study entailed prospective data collection from consecutive patients aged 18 and older, visiting a university-based orthopaedic spine clinic between October 2013 and January 2017. PATIENT SAMPLE: A total of 763 participants in the sample had a mean age of 58 (SD = 15) years and the sample was 50.2% male and 92.8% Caucasian. OUTCOME MEASURES: The PROMIS PF and PROMIS PI Computerized Adaptive Tests along with either the NDI or ODI instruments were administered on tablet computers before clinic visits. Global rating of change questions relating to pain and function levels was also administered. METHODS: Baseline scores were compared with follow-up scores at four different time-points from 3-months to 6-months and beyond. Patient demographics, mean scores, paired-sample t tests, Standardized Response Mean (SRM), and Effect Size (ES) were analyzed to determine instrument responsiveness. This project was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under award number U01AR067138 and the authors have no conflicts of interest to disclose. RESULTS: The PROMIS instruments were strongly correlated with each other as well as with the NDI and ODI. Responsiveness was significant on all four instruments at every time-point assessed (paired sample t tests ranged from p < .001 to p = .049). SRM's were large and over 0.94 for every instrument at every time-point. Cohen's d ES were large and over 0.96 for all at all time-points, except for the NDI which had ES ranging from 0.74 to 0.83. This study showed large effect sizes and responsiveness of the PROMIS PF, PROMIS PI, NDI and ODI in a population of orthopaedic patients with spine pathologies. CONCLUSION: This study demonstrates strong responsiveness of the PROMIS PF and PROMIS PI in a spine clinic population.

PROMIS and FAAM Minimal Clinically Important Differences in Foot and Ankle Orthopedics.

BACKGROUND:: Establishing score points that reflect meaningful change from the patient perspective is important for interpreting patient-reported outcomes. This study estimated the minimum clinically important difference (MCID) values of 2 Patient-Reported Outcomes Measurement Information System (PROMIS) instruments and the Foot and Ankle Ability Measure (FAAM) Sports subscale within a foot and ankle orthopedic population. METHODS:: Patients seen for foot and ankle conditions at an orthopedic clinic were administered the PROMIS Physical Function (PF) v1.2, the PROMIS Pain Interference (PI) v1.1, and the FAAM Sports at baseline and all follow-up visits. MCID estimation was conducted using anchor-based and distribution-based methods. RESULTS:: A total of 3069 patients, mean age of 51 years (range = 18-94), were included. The MCIDs for the PROMIS PF ranged from approximately 3 to 30 points (median = 11.3) depending on the methods being used. The MCIDs ranged from 3 to 25 points (median = 8.9) for the PROMIS PI, and from 9 to 77 points (median = 32.5) for the FAAM Sports. CONCLUSIONS:: This study established a range of MCIDs in the PROMIS PF, PROMIS PI, and FAAM Sports indicating meaningful change in patient condition. MCID values were consistent across follow-up periods, but were different across methods. Values below the 25th percentile of MCIDs may be useful for low-risk clinical decisions. Midrange values (eg, near the median) should be used for high stakes decisions in clinical practice (ie, surgery referrals). The MCID values within the interquartile range should be utilized for most decision making. LEVEL OF EVIDENCE:: Level I, diagnostic study, testing of previously developed diagnostic measure on consecutive patients with reference standard applied.

Evaluating the Prediction of Breast Cancer Survival Using Lymph Node Ratio.

PURPOSE: Previous oncological studies showed that lymph node ratio (LNR) (ratio of number of lymph nodes that tested positive for metastasis to the total number of lymph nodes examined) is a negative indicator of cancer survival. The American Joint Committee on Cancer (AJCC) staging system incorporates tumor size, lymph node involvement, and metastasis in a comprehensive model of cancer progression, but LNR alone has been shown to outperform the AJCC system in prognostic and survival predictions for various types of cancer. The effectiveness of LNR has not been evaluated in breast cancer staging. Evaluating LNR for predicting cancer staging in breast cancer has the potential to improve treatment recommendations. METHODS: The Surveillance, Epidemiology, and End Results dataset was used to identify 10,655 breast cancer patients who underwent nodal evaluation from 2010 to 2013, and their LNRs were calculated. Descriptive statistics of lymph node evaluation in the patients are provided. Logistic regression with LNR as the continuous independent variable was conducted to determine whether LNR could predict cancer progression, coded as regional or distant. Analysis was conducted using SPSS version 24. RESULTS: Patient's mean age was 59.43±18.62. Logistic regression analysis revealed that for every 1.3% increase in LNR, the odds of falling into the distant stage of the TNM staging system increased by 13.7% (odds ratio, 14.73; 95% confidence interval, 12.00-18.08). CONCLUSION: LNR, while correlated with breast cancer staging, serves as a better predictor of survival. Precision staging can influence treatment modality, and improved treatments can significantly improve quality of life. Additional research and diagnostic examinations using LNR as a potential tool for accurate staging in breast cancer patients are warranted.

What Are the MCIDs for PROMIS, NDI, and ODI Instruments Among Patients With Spinal Conditions?

BACKGROUND: As new Patient-Reported Outcomes Measurement Information System (PROMIS) instruments are incorporated into clinical practice, determining how large a change on these instruments represents a clinically relevant difference is important; the metric that describes this is the minimum clinically important difference (MCID). Prior research on MCIDs of the Neck Disability Index (NDI) and Oswestry Disability Index (ODI) has produced values ranging from 5 to 10 points, but these measures have not been presented in relation to MCID values of PROMIS instruments. QUESTIONS/PURPOSES: To establish a comprehensive repository of MCID values calculated both with distribution-based and anchor-based methods for four outcomes instruments in spine care, we asked: (1) What are the MCIDs of the PROMIS Physical Function (PF); (2) the PROMIS Pain Interference (PI); (3) the NDI; and (4) the ODI among spine patients? METHODS: We conducted a prospective study of previously tested diagnostic measures on 1945 consecutive patients with a reference standard applied. All patients aged 18 years and older visiting an orthopaedic spine clinic between October 2013 and January 2017 completed the PROMIS PF and PI, NDI, and ODI on tablet computers before their clinic visits. Patients were grouped by change level (self-report of meaningful change versus slight or no change) using an anchor question in comparison to baseline. Descriptive statistics, two anchor-based MCID values (mean change and receiver operating characteristic curve), and five distribution-based values (SD at 1/2 and 1/3 values and minimum detectable change [MDC] at 90%, 95%, and 99%) were analyzed four different times between 3 months and > 6 months of followup. A total of 1945 included patients with a wide range of spine conditions and varying treatments had a mean age of 58 years (SD = 15.5), were 51% (988 of 1945) male, 90% (1754 of 1945) self-identified as white, and 5% (94 of 1945) as Hispanic with 1% to 2% of patients refusing participation. RESULTS: The PROMIS PF mean change scores in the changed group (much worse, worse, improved, or much improved) ranged between 7 and 8 points. MCID values ranged from 3 to 23 points depending on the method of calculation with a median of 8. For the PROMIS PI, mean change scores ranged from 8 to 9 points and MCID values from 1 to 24 points with a median of 8. For the NDI, mean change scores ranged from 13 to 18 points and MCID values ranged from 6 to 43 points with a median of 18. For the ODI, mean change ranged from 17 to 19 points and MCID values ranged from 7 to 51 points with a median of 24. For each instrument, distribution-based SD yielded the smallest values, followed by anchor-based methods, with MDC yielding the largest MCID values. CONCLUSIONS: This study uses a range of methods for determining MCIDs of the PROMIS PF and PI, NDI, and ODI from anchor-based to distribution-based methods. MCIDs do not have a static value for a given outcome measure, but have a range of values and are dependent on the method calculated. The lowest MCIDs identified for the NDI and ODI are consistent with prior studies, but those at the upper range are much higher. Anchor-based methods are thought to be most relevant in the clinical setting and are more easily understood by clinicians, whereas the distribution-based MCIDs are useful in understanding population breadth. Lower MCID values may be most appropriate for screening purposes or low-risk effects, and the median or higher MCID values should be used for high-risk effects or outcomes. LEVEL OF EVIDENCE: Level I, diagnostic study.

Modified dynamic gait index and limits of stability in myotonic dystrophy type 1.

INTRODUCTION: The purpose of this study was to describe and compare the performance of balance and walking tests in relation to self-reported fall history in adults with myotonic dystrophy type 1 (DM1). METHODS: Twenty-two (13 male) participants with DM1 completed, a 6-month fall history questionnaire, the modified Dynamic Gait Index (mDGI), limits of stability (LoS) testing, and 10-m walking tests. RESULTS: Mean (SD) falls in 6 months was 3.7 (3.1), and 19 (86%) participants reported at least 1 fall. Significant differences in mDGI scores (P = 0.006) and 10-m fast walking gait velocity (P = 0.02) were found between those who had been classified as "fallers" and those who had been classified as "nonfallers." Significant correlations were found between mDGI scores and 10-m walking time. DISCUSSION: Falls are common in DM1, and the mDGI may have potential to distinguish fallers from nonfallers, whereas the LoS failed to detect such impairment. Future studies should further explore use of the mDGI in DM1. Muscle Nerve 58: 694-699, 2018.

The Charcot-Marie-Tooth Health Index: Evaluation of a Patient-Reported Outcome.

OBJECTIVE: The development of a disease-specific patient-reported outcome for Charcot-Marie-Tooth disease is an important step in the preparation for therapeutic trials. This study describes the development of the Charcot-Marie-Tooth Health Index (CMTHI). METHODS: Inherited Neuropathy Consortium Contact Registry participants were queried on the symptoms that most impacted their lives. The CMTHI was developed based on these responses. Factor analysis, assessment of test-retest reliability, known group validity, and patient interviews were utilized to refine the instrument. RESULTS: The final CMTHI contains 18 themes that capture Charcot-Marie-Tooth disease (CMT) burden. The CMTHI has a high internal consistency and test-retest reliability. The CMTHI was able to discriminate between patient groups expected to have different disease burden. The CMTHI was able to discriminate levels of disability as measured by the CMT examination score and the mobility-Disability Severity Index. INTERPRETATION: The CMTHI represents a valid and reliable outcome to assess patient-reported disease burden in CMT. Ann Neurol 2018;84:225-233.