Which outcome measures should be utilized to determine readiness to play after ACL reconstruction?

CLINICAL SCENARIO: Anterior cruciate ligament (ACL) injuries are associated with a lengthy recovery time, decreased performance, and an increased rate of reinjury. To improve performance of the injured knee, affected athletes often undergo surgical reconstruction and rehabilitation. Determining when an athlete is ready to safely return to play (RTP), however, can be challenging for clinicians. Although various outcome measures have been recommended, their ability to predict a safe RTP is questionable. FOCUSED CLINICAL QUESTION: Which outcome measures should be used to determine readiness to return to play after ACL reconstruction?

Readability of state-sponsored advance directive forms in the United States: a cross sectional study.

BACKGROUND: State governments provide preprinted advance directive forms to the general public. However, many adults in the United States (US) lack the skills necessary to read and comprehend health care-related materials. In this study, we sought to determine the readability of state government-sponsored advance directive forms. METHODS: A cross sectional study design was used. The readability of advance directive forms available online from all 50 US states and the District of Columbia was determined using 6 validated readability scales. RESULTS: Overall, 62 advance directive forms were obtained. For 47 states, forms were available by way of government-sponsored Web sites. The average (SD) readability (with the Flesch-Kincaid score) of all forms was grade level 11.9 (2.6). Similar results were obtained with the other readability scales. No form had a readability score at the 5th grade level or lower, the level recommended by the National Work Group on Literacy and Health. The readability of the forms exceeded this level by an average of 6.9 grade levels (95% confidence interval, 6.3-7.6; P < .001). Only 5 of the forms had a readability score at 8th grade level or lower, the average reading skill level of US adults. The readability of the forms exceeded this level by an average of 3.9 grade levels (95% confidence interval, 3.3-4.6; P < .001). CONCLUSIONS: The readability of US state government-sponsored advance directive forms exceeds the readability level recommended by the National Work Group on Literacy and Health and the average reading skill level of most US adults. Such forms may inhibit advance care planning and therefore patient autonomy.

Application of Machine Learning Models to Evaluate Hypoglycemia Risk in Type 2 Diabetes.

INTRODUCTION: To identify predictors of hypoglycemia and five other clinical and economic outcomes among treated patients with type 2 diabetes (T2D) using machine learning and structured data from a large, geographically diverse administrative claims database. METHODS: A retrospective cohort study design was applied to Optum Clinformatics claims data indexed on first antidiabetic prescription date. A hypothesis-free, Bayesian machine learning analytics platform (GNS Healthcare REFS™: Reverse Engineering and Forward Simulation) was used to build ensembles of generalized linear models to predict six outcomes defined in patients' 1-year post-index claims history, including hypoglycemia, antidiabetic class persistence, glycated hemoglobin (HbA1c) target attainment, HbA1c change, T2D-related inpatient admissions, and T2D-related medical costs. A unified set of 388 variables defined in patients' 1-year pre-index claims history constituted the set of predictors for all REFS models. RESULTS: The derivation cohort comprised 453,487 patients with a T2D diagnosis between 2014 and 2017. Patients with comorbid conditions had the highest risk of hypoglycemia, including those with prior hypoglycemia (odds ratio [OR] = 25.61) and anemia (OR = 1.29). Other identified risk factors included insulin (OR = 2.84) and sulfonylurea use (OR = 1.80). Biguanide use (OR = 0.75), high blood glucose (> 125 mg/dL vs. < 100 mg/dL, OR = 0.47; 100-125 mg/dL vs. < 100 mg/dL, OR = 0.53), and missing blood glucose test (OR = 0.40) were associated with reduced risk of hypoglycemia. Area under the curve (AUC) of the hypoglycemia model in held-out testing data was 0.77. Patients in the top 15% of predicted hypoglycemia risk constituted 50% of observed hypoglycemic events, 26% of T2D-related inpatient admissions, and 24% of all T2D-related medical costs. CONCLUSIONS: Machine learning models built within high-dimensional, real-world data can predict patients at risk of clinical outcomes with a high degree of accuracy, while uncovering important factors associated with outcomes that can guide clinical practice. Targeted interventions towards these patients may help reduce hypoglycemia risk and thereby favorably impact associated economic outcomes relevant to key stakeholders.

Evaluation of machine learning methodology for the prediction of healthcare resource utilization and healthcare costs in patients with critical limb ischemia-is preventive and personalized approach on the horizon?

BACKGROUND: Critical limb ischemia (CLI) is a severe stage of peripheral arterial disease and has a substantial disease and economic burden not only to patients and families, but also to the society and healthcare systems. We aim to develop a personalized prediction model that utilizes baseline patient characteristics prior to CLI diagnosis to predict subsequent 1-year all-cause hospitalizations and total annual healthcare cost, using a novel Bayesian machine learning platform, Reverse Engineering Forward Simulation™ (REFS™), to support a paradigm shift from reactive healthcare to Predictive Preventive and Personalized Medicine (PPPM)-driven healthcare. METHODS: Patients ≥ 50 years with CLI plus clinical activity for a 6-month pre-index and a 12-month post-index period or death during the post-index period were included in this retrospective cohort of the linked Optum-Humedica databases. REFS™ built an ensemble of 256 predictive models to identify predictors of all-cause hospitalizations and total annual all-cause healthcare costs during the 12-month post-index interval. RESULTS: The mean age of 3189 eligible patients was 71.9 years. The most common CLI-related comorbidities were hypertension (79.5%), dyslipidemia (61.4%), coronary atherosclerosis and other heart disease (42.3%), and type 2 diabetes (39.2%). Post-index CLI-related healthcare utilization included inpatient services (14.6%) and ≥ 1 outpatient visits (32.1%). Median annual all-cause and CLI-related costs per patient were $30,514 and $2196, respectively. REFS™ identified diagnosis of skin and subcutaneous tissue infections, cellulitis and abscess, use of nonselective beta-blockers, other aftercare, and osteoarthritis as high confidence predictors of all-cause hospitalizations. The leading predictors for total all-cause costs included region of residence and comorbid health conditions including other diseases of kidney and ureters, blindness of vision defects, chronic ulcer of skin, and chronic ulcer of leg or foot. CONCLUSIONS: REFS™ identified baseline predictors of subsequent healthcare resource utilization and costs in CLI patients. Machine learning and model-based, data-driven medicine may complement physicians' evidence-based medical services. These findings also support the PPPM framework that a paradigm shift from post-diagnosis disease care to early management of comorbidities and targeted prevention is warranted to deliver a cost-effective medical services and desirable healthcare economy.

The Effect of Implementing Gene Expression Classifier on Outcomes of Thyroid Nodules with Indeterminate Cytology.

Thyroid nodules are classified into six cytological categories under the Bethesda classification system. Two of these categories, atypical of undetermined significance (AUS) and suspicious for a follicular neoplasm (SFN), are further labeled as "indeterminate" diagnosis. Starting in June, 2012, Kansas University-Wichita Endocrine clinic implemented Afirma® Gene Expression Classifier (AGEC) to evaluate the need for surgical resection of thyroid nodules in patients with an indeterminate diagnosis. Electronic medical records of patients who underwent thyroid nodule fine-needle aspiration from 2004-2014 were reviewed. The aim of this study was to find whether implementing AGEC was associated with decreased surgical recommendation rate, decreased cost, and increased incidence of thyroid malignancy diagnosed by surgery in patients with indeterminate diagnosis. A total of 299 consecutive patients' charts were screened. Sixty-one (20 %) patients had an indeterminate diagnosis. Out of these, 27 (44 %) patients underwent evaluation before and 34 (56 %) patients underwent evaluation after AGEC implementation, respectively. Surgical recommendation for patients with indeterminate finding decreased from 81.5 to 50 % (p = 0.01) after AGEC implementation. Surgical pathology was read as malignant in 20 and 85.7 % (p < 0.01) of patients before and after AGEC implementation, respectively. Primary cost-benefit estimate showed implementing AGEC has saved $1048/patient in medical evaluation and initial management of patients with indeterminate diagnosis. AGEC implementation has decreased the number of surgical recommendations, has lowered financial burden, and has increased incidence of thyroid malignancy diagnosed by surgical pathology in patients with indeterminate diagnosis of thyroid nodules.

Choices for patients "without a choice": Interviews with patients who received a left ventricular assist device as destination therapy.

BACKGROUND: Patients undergo major physical and psychological changes after implantation of a left ventricular assist device as destination therapy (DT). We sought to qualitatively study outcomes and attitudes of patients after DT. METHODS AND RESULTS: Ambulatory outpatients with DT at our institution were invited to be interviewed between June and August 2011. In-person interviews were audio-recorded, transcribed, and analyzed qualitatively using thematic analysis. The study included 12 patients (11 men) from the Midwestern United States with a median age of 71.5 years (range, 33-78 years). Interviews were conducted at a median (range) time of 1.37 (0.43-5.04) years after DT implantation. Most patients were white (n=11), married (n=10), and Christian (n=10). We identified 6 themes commonly discussed by the interviewees: preparedness planning, new lease on life, optimizing support networks, systemic limitations, reflections on time, and communication matters. Analysis revealed that most patients saw DT as their only choice, despite other alternatives. CONCLUSIONS: Ambulatory patients reported varied experiences after DT but commonly reported gratitude for improved functional status and a perception of improved symptom burden. Recommendations for improving post-DT care include developing patient support systems, systematizing education for community providers, and expanding respite services.

Perspectives of patients with cardiovascular implantable electronic devices who received advisory warnings.

OBJECTIVE: To learn the perspectives of patients with cardiovascular implantable electronic devices (CIEDs) who received device-related advisories. BACKGROUND: CIEDs are placed under advisory because of potential malfunctions. METHODS: Qualitative methods were used. Focus groups were conducted of 10 patients who had CIEDs under advisory. Audio recordings of the focus group discussions were transcribed and analyzed for content in accordance with qualitative analysis methods, specifically thematic analysis. RESULTS: Major themes were identified: patients' attitudes toward their devices under advisory, education about advisories, emotional responses to advisories, impact on loved ones, and what affected patients would say to the chief executive officers of CIED manufacturers. Although the patients felt "fortunate and blessed" to have their devices, they reported a range of emotional responses to the advisories (from no concern to "outrage"). Patients preferred to learn about advisories from their physicians, not from news media. Loved ones had as many, if not more, advisory-related concerns than the patients. Patients had recommendations for chief executive officers of CIED manufacturers regarding advisories, including providing timely and comprehensible information and emotional support, taking responsibility, and collaborating with health care providers. Patients wanted to know what prompted the advisory and what will be done to fix the problem. CONCLUSIONS: The experiences and perspectives of patients with CIEDs under advisory not only encompass their emotional responses to advisories, but also their views on how the advisory notification process can be improved. These findings should be informative to CIED manufacturers and clinicians.

Readability of "Dear Patient" device advisory notification letters created by a device manufacturer.

BACKGROUND: In 2006, the Heart Rhythm Society (HRS) recommended that cardiovascular implantable electronic device (CIED) manufacturers use advisory notification letters to communicate with affected patients. OBJECTIVE: To evaluate the readability of the HRS sample "patient device advisory notification" letter and those created by 1 CIED manufacturer. METHODS: The HRS sample letter and 25 Boston Scientific Corporation letters dated from 2005 through 2011 were evaluated by using 6 readability tests. RESULTS: Readability (Flesch-Kincaid score) of the HRS sample letter was grade level 12.5, and median readability of the device manufacturer letters was grade level 12.8 (range 10.8-18.9). Similar results were obtained by using other readability scales. No letters had readability scores at the National Work Group on Literacy and Health's recommended reading level-fifth grade; the letters' readability exceeded this recommended level by an average of 7.7 grades (95% confidence interval 6.9-8.5; P<.001). Likewise, no letters had readability scores at the average reading level of US adults-eighth grade; the letters' readability exceeded this level by an average of 4.7 grades (95% confidence interval 3.9-5.5; P< .001). CONCLUSIONS: The readability of the HRS sample letter and those created by a CIED manufacturer significantly exceeded the recommended and average US adults' reading skill levels. Such letters are unlikely to be informative to many patients. CIED manufacturers should ensure that advisory letters are comprehensible to most affected patients.

"We as Human Beings Get Farther and Farther Apart": the experiences of patients with remote monitoring systems.

OBJECTIVE: To explore the experiences of patients living with an implantable cardioverter-defibrillator (ICD) who had received remote monitoring (RM). BACKGROUND: Anecdotal evidence suggests that not all patients with RM use the technology. METHODS: Focus groups of patients with an ICD who received an RM system. Transcripts reviewed using thematic analysis. RESULTS: Nine patients (3 women and 6 men; median [range] age, 73 [58-91] years) received an RM system. Patients were assigned to a group in regard to RM system use (nonusers, n = 5; users, n = 4). Few nonusers recalled having prior conversations about the system. Users described it as "simple" and "easy" to use. Nonusers often were unsure whether their system was correctly transmitting information. System benefits perceived by users included convenience and security. Nonusers expressed mistrust. Recommendations included early education and help lines. CONCLUSIONS: Patient adherence to RM systems can be improved by explaining perceived benefits and addressing barriers to use.

"Just Because We Can Doesn't Mean We Should": views of nurses on deactivation of pacemakers and implantable cardioverter-defibrillators.

PURPOSE: This study aims to identify nurses' concerns about the clinical, ethical, and legal aspects of deactivating cardiovascular implantable electronic devices (CIEDs). METHODS: We used focus groups to discuss decision making in CIED management. RESULTS: Fourteen nurses described the informed consent process as overly focused on procedures, with inadequate coverage of living with a device (e.g., infection risks and device shocks). Elderly patients were especially vulnerable to physician or family pressure about CIED implantation. Nurses believed that initial advance care planning discussions were infrequent and rarely revisited when health status changed. Many patients did not know that CIEDs could be deactivated; it was often addressed reactively (i.e., after multiple shocks) or when patients became too ill to participate in decision making. Nurses generally were supportive of CIED deactivation when it was requested by a well-informed patient. However, nurses distinguished between withholding versus withdrawing treatment (i.e., turning off CIEDs vs. declining implantation). Although most patients viewed their device as lifesaving, others perceived them as a "ticking time bomb." CONCLUSIONS: Nurses identified concerns about CIED decision making from implantation through end-of-life care and device deactivation and suggested avenues for improving patient care including early and regular advance care planning.

Evaluation of medical student experience using medical student created StudentPACS flash based PACS simulator tutorials for learning radiological topics.

RATIONALE AND OBJECTIVES: With studies regularly containing hundreds of images, the authors believe that the ability to efficiently review numerous images and identify findings is an important skill to teach medical students. Using the StudentPACS Adobe Flash extension, created within their department, the authors created StudentPACS modules that provide users with a virtual picture archiving and communication system environment, in which findings can be selected by mouse, triggering questions with referenced answers. The aim was to assess medical students' impressions of how learning from these modules compared to their personal experiences learning radiology from textbooks or static images. MATERIALS AND METHODS: StudentPACS modules were created by medical students on elective under the supervision of resident and attending radiologists. MS I to IV students were then asked to complete StudentPACS modules that tied in with their current coursework, followed by an anonymous survey. Approximately 293 students participated. RESULTS: The majority of students reported that StudentPACS modules were either equivalent to or better than learning from static images or textbooks (90 +/- 3% [257 of 285], P < .00002), were not difficult to use (85 +/- 4% [248 of 293], P < .00002), presented them with clinical content that tied in well with the depicted imaging (90 +/- 3% [263 of 293], P < .00002), and taught them new information (69 +/- 5% [202 of 293], P < .00002). Most respondents felt the StudentPACS modules presented information they would find useful in clinical practice (91 +/- 3% [266 of 293], P < .00002), reported satisfactory experiences using StudentPACS modules as a source of self-directed learning material (79 +/- 5% [232 of 293], P < .00002), and stated that they would use StudentPACS modules for learning different topics in the future (85.6 +/- 4% [244 of 285], P < .00002). CONCLUSION: Medical students found using StudentPACS modules at least equivalent to, if not better than, using static books or annotated images.