Integrated Osteopathic-Neurologic Examinations With Musculoskeletal Treatment: The ONE Approach.

The global burden of neurologic disorders is a leading cause of disability and death worldwide and has increased the demand for treatments and rehabilitation. Our proposed integrated osteopathic-neurologic examination (ONE) provides the physician with expanded diagnostic and point-of-care treatment modalities while allowing the physician to make a more tangible effect in patient care. By incorporating the osteopathic structural somatic examination with the complete neurologic evaluation, somatic dysfunction, occurring as a consequence or independent of neurologic injury, can be identified and treated using osteopathic manipulative techniques at time of visit. Using the proposed integrated examination, the physician can determine the interplay between structural and neurologic findings to identify patterns of change that coincide with more specific diagnoses and the chronicity of a condition. Tangible benefits from the ONE approach translate to more accurate clinical assessment and enhanced patient and physician satisfaction.

Deaths and Severe Adverse Events after the use of Mifepristone as an Abortifacient from September 2000 to February 2019.

OBJECTIVES: Primary: Analyze the Adverse Events (AEs) reported to the Food and Drug Administration (FDA) after use of mifepristone as an abortifacient. Secondary: Analyze maternal intent after ongoing pregnancy and investigate hemorrhage after mifepristone alone. METHODS: Adverse Event Reports (AERs) for mifepristone used as an abortifacient, submitted to the FDA from September 2000 to February 2019, were analyzed using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAEv3). RESULTS: The FDA provided 6158 pages of AERs. Duplicates, non-US, or AERs previously published (Gary, 2006) were excluded. Of the remaining, there were 3197 unique, US-only AERs of which there were 537 (16.80%) with insufficient information to determine clinical severity, leaving 2660 (83.20%) Codable US AERs. (Figure 1). Of these, 20 were Deaths, 529 were Life-threatening, 1957 were Severe, 151 were Moderate, and 3 were Mild.The deaths included: 9 (45.00%) sepsis, 4 (20.00%) drug toxicity/overdose, 1 (5.00%) ruptured ectopic pregnancy, 1 (5.00%) hemorrhage, 3 (15.00%) possible homicides, 1 (5.00%) suicide, 1 (5.00%) unknown. (Table 1).Retained products of conception and hemorrhage caused most morbidity. There were 75 ectopic pregnancies, including 26 ruptured ectopics (includes one death).There were 2243 surgeries including 2146 (95.68%) D&Cs of which only 853 (39.75%) were performed by abortion providers.Of 452 patients with ongoing pregnancies, 102 (22.57%) chose to keep their baby, 148 (32.74%) had terminations, 1 (0.22%) miscarried, and 201 (44.47%) had unknown outcomes.Hemorrhage occurred more often in those who took mifepristone and misoprostol (51.44%) than in those who took mifepristone alone (22.41%). CONCLUSIONS: Significant morbidity and mortality have occurred following the use of mifepristone as an abortifacient. A pre-abortion ultrasound should be required to rule out ectopic pregnancy and confirm gestational age. The FDA AER system is inadequate and significantly underestimates the adverse events from mifepristone.A mandatory registry of ongoing pregnancies is essential considering the number of ongoing pregnancies especially considering the known teratogenicity of misoprostol.The decision to prevent the FDA from enforcing REMS during the COVID-19 pandemic needs to be reversed and REMS must be strengthened.

Pilot study utilizing MRI 3D TGSE PASL (arterial spin labeling) differentiating clearance rates of labeled protons in the CNS of patients with early Alzheimer disease from normal subjects.

OBJECTIVE: To determine the feasibility of 3D TGSE PASL MRI with long inversion times to estimate CNS perfusion clearance, comparing normals to Alzheimer disease patients. METHODS: This pilot study used 3D TGSE PASL MRI with long TIs to estimate the signal clearance of labeled blood/ultra-filtrate (CSF) from brain signal averages of seven inversion times (TI) from six regions of the brain in 18 normal subjects of ages 18-70 years before and after exercise. Arterial pulse corrected signal average per TI versus TI was plotted. The slope (linear regression) indicated the clearance rate. Three subjects with mild Alzheimer disease (AD) were studied pre-exercise only. RESULTS: In normals, signal decay rate variance among brain regions, age groups and post-exercise failed to demonstrate statistical significance except in middle-age group pre- to post-exercise-dominant temporal lobe. We found highly statistically significant reduced signal clearance rate in the AD group. DISCUSSION: Signal decay in normal age groups correlates with decay of T1blood, thus CSF paravascular flow egresses and is inseparable from venous outflow. The AD group correlates with decay rate T1CSF, indicating a proportion of labeled blood ultra-filtered within the brain (paravascular fluid) is retained. This provides indirect evidence of reduced paravascular clearance in AD. Further development may produce an efficient biomarker identifying neurodegenerative diseases and future treatment efficacy.

Feasibility of Using Ultrasonography to Establish Relationships Among Sacral Base Position, Sacral Sulcus Depth, Body Mass Index, and Sex.

CONTEXT: Identifying relationships among anatomical structures is key in diagnosing somatic dysfunction. Ultrasonography can be used to visualize anatomical structures, identify sacroiliac landmarks, and validate anatomical findings and measurements in relation to somatic dysfunction. As part of the osteopathic manipulative medicine course at A.T. Still University-Kirksville College of Osteopathic Medicine, first-year students are trained to use ultrasonography to establish relationships among musculoskeletal structures. OBJECTIVES: To determine the ability of first-year osteopathic medical students to establish sacral base position (SBP) and sacral sulcus depth (SSD) using ultrasonography and to identify the relationship of SBP and SSD to body mass index (BMI) and sex. METHODS: Students used ultrasonography to obtain the distance between the skin and the sacral base (the SBP) and the distance between the skin and the tip of the posterior superior iliac spine bilaterally. Next, students calculated the SSD (the distance between the tip of the posterior superior iliac spine and the SBP). Data were analyzed with respect to side of the body, BMI, sex, and age. The BMI data were subdivided into normal (18-25 mg/kg) and overweight (25-30 mg/kg) groups. RESULTS: Ultrasound images of 211 students were included in the study. The SBP was not significantly different between the left and right sides (36.5 mm vs 36.5 mm; P=.95) but was significantly different between normal and overweight BMI categories (33.0 mm vs 40.0 mm; P<.001) and between men and women (34.1 mm vs 39.0 mm; P<.001). The SSD was not significantly different between left and right sides (18.9 mm vs 19.8 mm; P=.08), normal and overweight BMI categories (18.9 mm vs 19.7 mm, P=.21), or men and women (19.7 mm vs 19.0 mm; P=.24). No significant relationship was identified between age and SBP (P=.46) or SSD (P=.39); however, the age range was narrow (21-33 years). CONCLUSION: The study yielded repeatable and reproducible results when establishing SBP and SSD using ultrasonography. The statistically significant relationship between SBP and higher BMI and between SBP and female sex may point to more soft tissue overlaying the sacrum in these groups. Further research is needed on the use of ultrasonography to establish criteria for somatic dysfunction.

Incidence of Somatic Dysfunction in Healthy Newborns.

CONTEXT: Recent evidence suggests that osteopathic manipulative treatment of somatic dysfunction in newborns may decrease complications and hospital length of stay. Such dysfunction may result from external forces related to the birth process, but its incidence is unknown. OBJECTIVE: To identify the incidence and patterns of somatic dysfunction in healthy newborns at least 6 hours after birth and to correlate those findings with maternal and labor history, gestational age, and findings of the initial newborn assessment performed immediately after birth. METHODS: Healthy newborns aged 6 to 72 hours were physically examined and assessed for somatic dysfunction, including asymmetry and motion restriction of the cranial, cervical, lumbar, and sacral regions. The total somatic dysfunction identified was summarized in a somatic dysfunction severity score (SDSS), calculated by assigning 1 point for each identified finding; the SDSS could range from 0 (no somatic dysfunction) to 34 (all somatic dysfunctions assessed present). Findings were correlated with maternal and newborn characteristics and labor history. Descriptive analyses were performed, and findings were compared between the initial newborn assessment and the research examination. RESULTS: One hundred newborns were examined (mean gestational age, 38.5 weeks). In 99 newborns (99%), at least 1 sphenobasilar synchondrosis strain pattern was present, with sidebending rotations being the most common (present in 63 newborns [63%]). Condylar compression was found in 95 newborns (95%), temporal bone restrictions in 85 (85%), motion restriction of at least 1 cervical vertebral segment in 91 (91%) and at least 1 lumbar vertebral segment in 94 (94%), and a posterior sacral base in 80 (80%). The SDSS was not associated with mode of delivery or labor augmentation (P=.49 and P=.54, respectively), but it was positively associated with the duration of labor; each 1-hour increase in labor increased the predicted SDSS by 0.12 points (P=.04). CONCLUSION: Somatic dysfunction of the cranial, cervical, lumbar, and sacral regions was common in healthy newborns, and the total somatic dysfunction (SDSS) was related to the length of labor. (ClinicalTrials.gov number NCT01496872).

Innovative approach to teaching osteopathic manipulative medicine: the integration of ultrasonography.

CONTEXT: Noninvasive diagnostic methods and palpatory physical examination skills are especially important for osteopathic medical students intending to work in rural, underresourced, or underserved areas. The A.T. Still University-Kirksville College of Osteopathic Medicine integrates ultrasonography into the osteopathic manipulative medicine (OMM) courses required during the first 2 years of medical school, allowing students to learn the technology and to visualize anatomical structures and regions. OBJECTIVE: To assess the feasibility of integrating ultrasonography into the first-year and second-year OMM curriculum through the evaluation of students' success in demonstrating the technology and visualizing the anatomy. METHODS: As part of their OMM requirements at the A.T. Still University-Kirksville College of Osteopathic Medicine, all first- and second-year students in OMM courses were given ultrasonography assignments that required them to obtain images of musculoskeletal structures in different regions of the body. First-year students studied craniocervical structures and the thoracic, lumbar, and sacral regions. Second-year students studied the glenohumeral joint and the suprapatellar recess. The assignments focused on identifying structures of interest, making annotations, and measuring the structures of interest. Handouts with detailed instructions and a demonstration were provided before each assignment. RESULTS: A total of 183 first-year students and 165 second-year students participated. Of the first-year students, on average, 177 of 181 were able to successfully complete the assignments, with an average completion rate of 98%. The costotransverse joint assignment yielded the lowest completion rate (97%), and the craniocervical landmarks assignment had the highest completion rate (99%). Of the second-year students, 162 of 165 participants were able to successfully complete the assignments, with an average completion rate of 98%. Mean scores were the same for both second-year assignments. CONCLUSION: First-year and second-year osteopathic medical students successfully demonstrated their use and understanding of ultrasonography and found their assigned structures using live ultrasound imaging. The skills gained through these assignments added another dimension to students' understanding of normal and pathologic musculoskeletal anatomy and vasculature. The integration of ultrasonography into OMM courses may have created a foundation for learning ultrasound-guided injection techniques.

Curricular analysis of competency-based osteopathic medical education: application of a matrix for quality enhancement to a standardized patient encounter example.

CONTEXT: With the formal adoption of the seven core competencies, the American Osteopathic Association's Commission on Osteopathic College Accreditation instructed osteopathic medical educators to guide curricular development with these goals in mind. Tools to facilitate and monitor these purposes have been under development separately at each of the nation's colleges of osteopathic medicine. OBJECTIVE: To demonstrate the utility of a checklist-based curriculum assessment tool, the Matrix for Quality Enhancement, as developed at Kirksville (Mo) College of Osteopathic Medicine-A.T. Still University. METHODS: APPLICATION of the Matrix is illustrated using examples selected from our analysis of a set of 16 standardized patient encounters provided as part of a first-year basic science course in medical microbiology. Encounters were developed to improve student understanding of infectious disease entities while also providing a variety of clinical experiences. Feedback on professionalism and humanistic behaviors was also provided. A novel aspect of the Matrix is the inclusion of a component dealing with patient safety. APPLICATION: Adding standardized patient encounters to the medical microbiology teaching program at Kirksville College of Osteopathic Medicine was an effective means of integrating educational experiences with the seven core competencies, the requirements of Comprehensive Osteopathic Medical Licensing Examination-USA Level 2-PE (Performance Evaluation), and patient safety issues. CONCLUSION: The Matrix is a valuable tool for evaluating or developing curricular components that maintain osteopathic integrity while working toward standards for medical education specified by the commission.

Osteopathic manipulative treatment in prenatal care: a retrospective case control design study.

The use of osteopathic manipulative treatment (OMT) during pregnancy has a long tradition in osteopathic medicine. A retrospective study was designed to compare a group of women who received prenatal OMT with a matched group that did not receive prenatal OMT. The medical records of 160 women from four cities who received prenatal OMT were reviewed for the occurrence of meconium-stained amniotic fluid, preterm delivery, use of forceps, and cesarean delivery. The randomly selected records of 161 women who were from the same cities, but who did not receive prenatal OMT, were reviewed for the same outcomes. The results of a logistic regression analysis were statistically reliable, chi2 (4, N = 321) = 26.55; P < .001, indicating that the labor and delivery outcomes, as a set, were associated with whether OMT was administered during pregnancy. According to the Wald criterion, prenatal OMT was significantly associated with meconium-stained amniotic fluid (Z = 13.20, P < .001) and preterm delivery (Z = 9.91; P < .01), while the use of forceps was found to be marginally significant (Z = 3.28; P = .07). The case control study found evidence of improved outcomes in labor and delivery for women who received prenatal OMT, compared with women who did not. A prospective study is proposed as the next step in evaluating the effects of prenatal OMT.