Interventions to de-implement unnecessary antibiotic prescribing for ear infections (DISAPEAR Trial): protocol for a cluster-randomized trial.

BACKGROUND: Watchful waiting management for acute otitis media (AOM), where an antibiotic is used only if the child's symptoms worsen or do not improve over the subsequent 2-3 days, is an effective approach to reduce antibiotic exposure for children with AOM. However, studies to compare the effectiveness of interventions to promote watchful waiting are lacking. The objective of this study is to compare the effectiveness and implementation outcomes of two pragmatic, patient-centered interventions designed to facilitate use of watchful waiting in clinical practice. METHODS: This will be a cluster-randomized trial utilizing a hybrid implementation-effectiveness design. Thirty-three primary care or urgent care clinics will be randomized to one of two interventions: a health systems-level intervention alone or a health systems-level intervention combined with use of a shared decision-making aid. The health systems-level intervention will include engagement of a clinician champion at each clinic, changes to electronic health record antibiotic orders to facilitate delayed antibiotic prescriptions as part of a watchful waiting strategy, quarterly feedback reports detailing clinicians' use of watchful waiting individually and compared with peers, and virtual learning sessions for clinicians. The hybrid intervention will include the health systems-level intervention plus a shared decision-making aid designed to inform decision-making between parents and clinicians with best available evidence. The primary outcomes will be whether an antibiotic was ultimately taken by the child and parent satisfaction with their child's care. We will explore the differences in implementation effectiveness by patient population served, clinic type, clinical setting, and organization. The fidelity, acceptability, and perceived appropriateness of the interventions among different clinician types, patient populations, and clinical settings will be compared. We will also conduct formative qualitative interviews and surveys with clinicians and administrators, focus groups and surveys of parents of patients with AOM, and engagement of two stakeholder advisory councils to further inform the interventions. DISCUSSION: This study will compare the effectiveness of two pragmatic interventions to promote use of watchful waiting for children with AOM to reduce antibiotic exposure and increase parent satisfaction, thus informing national antibiotic stewardship policy development. CLINICAL TRIAL REGISTRATION: NCT06034080.

Cost-Effectiveness of AF Screening With 2-Week Patch Monitors: The mSToPS Study.

BACKGROUND: The mSToPS study (mHealth Screening to Prevent Strokes) reported screening older Americans at risk for atrial fibrillation (AF) and stroke using 2-week patch monitors was associated with increased rates of AF diagnosis and anticoagulant prescription within 1 year and improved clinical outcomes at 3 years relative to matched controls. Cost-effectiveness of this AF screening approach has not been explored. METHODS: We conducted a US-based health economic analysis of AF screening using patient-level data from mSToPS. Clinical outcomes, resource use, and costs were obtained through 3 years using claims data. Individual costs, survival, and quality-adjusted life years (QALYs) were projected over a lifetime horizon using regression modeling, US life tables, and external data where needed. Adjustment between groups was performed using propensity score bin bootstrapping. RESULTS: Screening participants (mean age, 74 years, 41% female, median CHA2DS2-VASC score 3) wore on average 1.7 two-week monitors at a mean cost of $614/person. Over 3 years, outpatient visits were more frequent for monitored than unmonitored individuals (difference 190 per 100 patient-years [95% CI, 82-298]), but emergency department visits (-8.3 [95% CI, -12.6 to -4.1]) and hospitalizations (-15.2 [CI, -22 to -8.6]) were less frequent. Total adjusted 3-year costs were slightly higher (mean difference, $1551 [95% CI, -$1047 to $4038]) in the monitoring group. In patient-level projections, the monitoring group had slightly greater quality-adjusted survival (8.81 versus 8.71 QALYs, difference, 0.09 [95% CI, -0.05 to 0.24]) and slightly higher lifetime costs, resulting in an incremental cost-effectiveness ratio of $36 100/QALY gained. With bootstrap resampling, the incremental cost-effectiveness ratio for monitoring was <$50 000/QALY in 64% of study replicates, and <$150 000/QALY in 91%. CONCLUSIONS: Using lifetime projections derived from the mSToPS study, we found that AF screening using 2-week patch monitors in older Americans was associated with high economic value. Confirmation of these uncertain findings in a randomized trial is warranted. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02506244.

Reducing length of antibiotics for children with ear infections: protocol for a cluster-randomized trial in the USA.

Aim: Preventing unnecessarily long durations of antibiotic therapy is a key opportunity to reduce antibiotic overuse in children 2 years of age and older with acute otitis media (AOM). Pragmatic interventions to reduce durations of therapy that can be effectively scaled and sustained are urgently needed. This study aims to fill this gap by evaluating the effectiveness and implementation outcomes of two low-cost interventions of differing intensities to increase guideline-concordant antibiotic durations in children with AOM. Methods: The higher intensity intervention will consist of clinician education regarding guideline-recommended short durations of antibiotic therapy; electronic health record (EHR) prescription field changes to promote prescribing of recommended short durations; and individualized clinician audit and feedback on adherence to recommended short durations of therapy in comparison to peers, while the lower intensity intervention will consist only of clinician education and EHR changes. We will explore the differences in implementation effectiveness by patient population served, clinician type, clinical setting and organization as well as intervention type. The fidelity, feasibility, acceptability and perceived appropriateness of the interventions among different clinician types, patient populations, clinical settings and intervention type will be compared. We will also conduct formative qualitative interviews with clinicians and administrators and focus groups with parents of patients to further inform the interventions and study. The formative evaluation will take place over 1.5 years, the interventions will be implemented over 2 years and evaluation of the interventions will take place over 1.5 years. Discussion: The results of this study will provide a framework for other healthcare systems to address the widespread problem of excessive durations of therapy for AOM and inform national antibiotic stewardship policy development. Clinical Trial Registration: NCT05608993 (ClinicalTrials.gov).

Intramuscular alfaxalone with or without buprenorphine or hydromorphone provides sedation with minimal adverse effects in healthy rabbits (Oryctolagus cuniculus) in a randomized blinded controlled trial.

OBJECTIVE: To evaluate the effects of alfaxalone administered IM with or without buprenorphine or hydromorphone in healthy rabbits (Oryctolagus cuniculus). ANIMALS: 24 male rabbits undergoing elective orchiectomy between August 21, 2021, and November 6, 2021. PROCEDURES: In this controlled clinical trial, rabbits were randomly assigned to receive alfaxalone (4 mg/kg, IM) alone (group A; n = 8) or with buprenorphine (0.03 mg/kg, IM; group BA; 8) or hydromorphone (0.1 mg/kg, IM; group HA; 8). Vital signs and sedation scores were recorded immediately prior to (T0) and 10 minutes after (T1) treatment. Ease of IV catheter placement and pain scores were also evaluated. All rabbits received ketamine (2.5 mg/kg, IV), midazolam (0.13 mg/kg, IV), and meloxicam (0.5 mg/kg, SC) before orchiectomy but after IM treatments. Results were compared across groups with ANOVA or Fisher exact tests and across time with paired t tests. RESULTS: Sedation score, median time to recumbency, and ease of catheter placement did not differ among groups. Supraglottic airway device placement was possible for 1 rabbit in group A, 1 in group BA, and 2 in group HA. Mean respiratory rate at T1 versus T0 was significantly decreased for groups BA (63.8 vs 128.6 breaths/min) and HA (66.7 vs 123.2 breaths/min). Mean postoperative pain scores were significantly lower for rabbits in group HA (0.58), compared with those in groups A (2.25) and BA (2.06). CLINICAL RELEVANCE: All 3 treatments provided reliable sedation; however, alfaxalone (4 mg/kg, IM) combined with hydromorphone (0.1 mg/kg, IM) may be a better choice for painful procedures.

Assessment of communication and physical exam skills: A comparison of students, faculty and standardized patients.

PURPOSE/OBJECTIVES: The objective of this retrospective study was twofold: it aimed to investigate dental students' communication and physical exam self-assessment skills by comparing students' self-evaluations with those completed by faculty and standardized patients (SPs). Second, it aimed to compare faculty and SPs assessment of students' communication skills. METHODS: At the end of their first year of training, students (n = 127), participated in one SP encounter about an initial dental consultation. Students completed self-assessment before receiving feedback from faculty (n = 19) and SPs (n = 19). The data source included evaluation forms submitted by students, faculty and SPs. The Wilcoxon signed rank test was used to compare the overall scores between groups. Agreement between evaluations items were analyzed with McNemar's test (p < 0.05). RESULTS: Overall, there were no statistically significant differences in how students and faculty graded for either communication (p = 0.6724) or physical exam (p = 0.1921) skills. However, both students and faculty provided less favorable marks than SPs for communication skills with a statistically significant difference in the overall grading between both students and SPs (p = 0.0146) and between faculty and SPs (p = 0.0045). CONCLUSIONS: While there was disagreement between students and faculty versus SPs, they weren't meaningful differences in scores and the dissimilarities mainly consisted of ratings of explanation skills. We suggest that, when applicable, dental student's self-evaluations may represent an alternative to faculty assessments of communication and physical exam skills. Nonetheless, we recommend that SPs be included in the assessment of communication skills to provide students with comprehensive feedback that more realistically represents the natural patient-provider relationship.

Evaluating for a correlation between osteopathic examination and ultrasonography on thoracic spine asymmetry.

CONTEXT: The thoracic spine is a common area of focus in osteopathic manipulative medicine (OMM) for a variety of conditions. Thoracic spine somatic dysfunction diagnosis is achieved by palpating for asymmetry at the tips of the transverse processes (TPs). Previous studies reveal that instead of following the rule of threes, the TPs of a given thoracic vertebra generally align with the spinous process (SP) of the vertebra above. Ultrasonography has been widely utilized as a diagnostic tool to monitor musculoskeletal conditions; it does not utilize ionizing radiation, and it has comparable results to gold-standard modalities. In the case of thoracic somatic dysfunction, ultrasound (US) can be utilized to determine the location of each vertebral TP and its relationship with the SP. Previous studies have investigated the correlation between OMM and ultrasonography of the cervical, lumbar, and sacral regions. However, there has been no study yet that has compared osteopathic structural examination with ultrasonographic examination of the thoracic vertebral region. OBJECTIVES: To examine the relationship between osteopathic palpation and ultrasonographic measurements of the thoracic spine by creating a study design that utilizes interexaminer agreement and correlation. METHODS: The ClinicalTrials.gov study identifier is NCT04823637. Subjects were student volunteers recruited from the Midwestern University (MWU)-Glendale campus. A nontoxic, nonpermanent marker was utilized to mark bony landmarks on the skin. Two neuromusculoskeletal board-certified physicians (OMM1, OMM2) separately performed structural exams by palpating T2-T5 TPs to determine vertebral rotation. Two sonographers (US1, US2) separately scanned and measured the distance from the tip of the SP to the adjacent TPs of the vertebral segment below. Demographic variables were summarized with mean and standard deviation. Interexaminer agreement was assessed with percent agreement, Cohen's Kappa, and Fleiss' Kappa. Correlation was measured by Spearman's rank correlation coefficient. Recruitment and protocols were approved by the MWU Institutional Review Board (IRB). RESULTS: US had fair interexaminer agreement for the overall most prominent segmental rotation of the T3-T5 thoracic spine, with Cohen's Kappa at 0.27 (0.09, 0.45), and a total agreement percentage at 51.5%. Osteopathic palpation revealed low interexaminer agreement for the overall most prominent vertebral rotation, with Cohen's Kappa at 0.05 (0.0, 0.27), and 31.8%. Segment-specific vertebral analysis revealed slight agreement between US examiners, with a correlation coefficient of 0.23, whereas all other pairwise comparisons showed low agreement and correlation. At T4, US had slight interexaminer agreement with 0.24 correlation coefficient, and osteopathic palpation showed low interexaminer (OMM1 vs. OMM2) agreement (0.17 correlation coefficient). At T5, there was moderate agreement between the two sonographers with 0.44 (0.27, 0.60) and 63.6%, with a correlation coefficient of 0.57, and slight agreement between OMM1 and OMM2 with 0.12 (0.0, 0.28) and 42.4%, with 0.23 correlation coefficient. CONCLUSIONS: This preliminary study of an asymptomatic population revealed that there is a low-to-moderate interexaminer reliability between sonographers, low-to-slight interexaminer reliability between osteopathic physicians, and low interexaminer reliability between OMM palpatory examination and ultrasonographic evaluation of the thoracic spine.

COMPARISON OF FECAL CYTOLOGY AND PRESENCE OF CLOSTRIDIUM PERFRINGENS ENTEROTOXIN IN CAPTIVE BLACK-FOOTED FERRETS (MUSTELA NIGRIPES) BASED ON DIET AND FECAL QUALITY.

The black-footed ferret (Mustela nigripes) is an endangered mustelid native to North America. Gastroenteritis is a documented cause of morbidity and mortality in managed individuals, particularly by infectious agents. Fecal cytology is an inexpensive and rapid test that can help guide clinical management strategies for animals with enteritis; however, normal parameters have not been established in black-footed ferrets. The objective of this study was to characterize fecal cytological findings of 50 fecal samples from 18 black-footed ferrets that received two different diet types (ground meat versus whole prey) and that were visibly judged to be normal or abnormal. This study also tested for the presence of Clostridium perfringens enterotoxin by enzyme-linked immunosorbent assay in all abnormal and a subset of normal fecal samples. Significantly higher spore-forming bacteria and yeast prevalence were present in normal feces from individuals following the meat-based compared with the whole-prey diet. Samples from individuals with abnormal feces had significantly more spore-forming bacteria than normal feces, regardless of diet. Normal feces had higher diplococci and spore-forming bacteria compared with domestic canine and feline standards. A single abnormal fecal sample was positive for enterotoxin and originated from the only animal requiring treatment. Results indicate that low numbers of spore-forming bacteria can be found in fecal samples from clinically normal black-footed ferrets. Fecal cytology shows significantly increased spore-formers in clinically abnormal ferrets and in clinically normal ferrets following a ground meat-based diet.

Predictors of preclinical hand skill performance in dental school.

CONTEXT: Preclinical dental school instructors often observe some first-year students develop hand skills required for dental procedures more quickly and more easily than their peers. When questioned regarding prior experience, these advanced students often participated in physical activities that seem to predispose them to adapt their previously learned psychomotor hand skills to those required for dentistry. OBJECTIVE: This study examines the results of an Institutional Review Board approved 22-question survey of various lifelong predental school activities and correlations to first-year and second-year simulation clinic practical exam performance. DESIGN: The survey was taken anonymously at the Midwestern University College of Dental Medicine-Arizona by 4 consecutive dental school classes of 2017-2020 composed of 560 students, 552 of which responded. The purpose was to discover associations between lifelong activities and practical exam scores that may act as predictors of preclinical ability to develop visualization and psychomotor hand skills required for dental procedures. RESULTS: Higher preclinical practical scores were found to have the most correlation with higher levels of participation in psychomotor, artistic and outdoor physical activities. Participation in computer, musical instrument and culinary activities had no significant correlation, and prior experience in the medical or dental field had a negative correlation. CONCLUSION: The lack of participation in these predisposing lifelong activities may predict slower development of dental hand skills and signal the need for more hands-on tutorial instruction in the simulation clinic so these students do not lag behind their peers.

Adverse Events Due to Insomnia Drugs Reported in a Regulatory Database and Online Patient Reviews: Comparative Study.

BACKGROUND: Patient online drug reviews are a resource for other patients seeking information about the practical benefits and drawbacks of drug therapies. Patient reviews may also serve as a source of postmarketing safety data that are more user-friendly than regulatory databases. However, the reliability of online reviews has been questioned, because they do not undergo professional review and lack means of verification. OBJECTIVE: We evaluated online reviews of hypnotic medications, because they are commonly used and their therapeutic efficacy is particularly amenable to patient self-evaluation. Our primary objective was to compare the types and frequencies of adverse events reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) with analogous information in patient reviews on the consumer health website Drugs.com. The secondary objectives were to describe patient reports of efficacy and adverse events and assess the influence of medication cost, effectiveness, and adverse events on user ratings of hypnotic medications. METHODS: Patient ratings and narratives were retrieved from 1407 reviews on Drugs.com between February 2007 and March 2018 for eszopiclone, ramelteon, suvorexant, zaleplon, and zolpidem. Reviews were coded to preferred terms in the Medical Dictionary for Regulatory Activities. These reviews were compared to 5916 cases in the FAERS database from January 2015 to September 2017. RESULTS: Similar adverse events were reported to both Drugs.com and FAERS. Both resources identified a lack of efficacy as a common complaint for all five drugs. Both resources revealed that amnesia commonly occurs with eszopiclone, zaleplon, and zolpidem, while nightmares commonly occur with suvorexant. Compared to FAERS, online reviews of zolpidem reported a much higher frequency of amnesia and partial sleep activities. User ratings were highest for zolpidem and lowest for suvorexant. Statistical analyses showed that patient ratings are influenced by considerations of efficacy and adverse events, while drug cost is unimportant. CONCLUSIONS: For hypnotic medications, online patient reviews and FAERS emphasized similar adverse events. Online reviewers rated drugs based on perception of efficacy and adverse events. We conclude that online patient reviews of hypnotics are a valid source that can supplement traditional adverse event reporting systems.