Clinically defining the opioid-exposed birthing person and infant as a dyad to support bedside care, surveillance, and research.

Introduction: An increased incidence of maternal opioid use disorder (OUD) and neonatal abstinence syndrome (NAS) has prompted recommendations supporting a dyadic approach to care for birthing persons and their infants. However, there are no consensus guidelines outlining how the dyad is clinically defined. Methods: To examine how the opioid-exposed birthing person-infant dyad has been defined for purposes of data collection and research, a literature review applying the RAND/UCLA Appropriateness Method was conducted. Results: The search yielded 320 abstracts, with 110 articles identified as having a dyadic focus. While no articles included a specific definition for the dyad, 33 (30%) contained a descriptive reference to the birthing person-infant dyad. Thematic analysis revealed eight recurring elements characteristic of the dyad: (1) engagement, (2) communication, (3) bonding, (4) attachment, (5) mutual responsiveness, (6) reciprocity, (7) synchrony, and (8) attunement. Integrating these elements revealed the interactional relationship between the opioid-exposed birthing person and infant as the foundational principle that defines the dyad. Discussion: This definition shifts the focus of the opioid-exposed dyad from two individual patient populations to an interactional relationship that has broad applicability for clinical use, public health data collection, and research considerations.

A Dyadic Framework of Care for Opioid-exposed Birthing Persons and Their Infants and Children.

OBJECTIVE: To develop a dyadic-centered framework focused on clinical care, surveillance, and research for birthing persons with opioid use disorder (OUD) and their infants and children. STUDY DESIGN: Between February and March 2023, an analysis was conducted within the US Department of Health and Human Services (HHS) of activities directed at opioid-exposed birthing persons and their infants and children (the dyad) to identify: 1) number of activities, stratified by type and 2) characteristics across health and supportive activities that serve the dyad vs birthing persons or infants and children individually. Descriptive and thematic analyses were used to assess quantity and characteristics of fiscal year 2023-2024 activities aggregated across eleven HHS agencies. RESULTS: Of 181 activities examined, 75 met inclusion criteria specific to serving birthing persons with OUD and opioid-exposed infants and children. Sixty-two percent of activities were dyad focused. Five categories of dyadic activities were identified: research (45%), education and training (28%), health and supportive services (21%), surveillance (4%), and quality improvement (2%). Eight specific characteristics were key to dyadic activities: a life course and generational approach, emphasis on relationship, dyadic outcomes, service wraparound, payment structures supporting dyadic care, data linkage, and social determinants of health. CONCLUSIONS: This analysis of HHS activities directed at birthing persons with OUD and opioid-exposed infants and children showed that most programs had a dyadic focus. Synthesizing elements identified from activities serving the dyad facilitated the development of a dyadic framework integrating clinical care, public health surveillance, and research.

Correlation of clinical findings of temporomandibular joint with serological results in rheumatoid arthritis patients.

OBJECTIVES: This study aimed to determine the frequency of temporomandibular joint (TMJ) involvement in patients with rheumatoid arthritis (RA) and to find out the correlation of serological tests with clinical symptoms of TMJs in RA patients. PATIENTS AND METHODS: This cross-sectional study was performed on 40 patients with RA classified into two groups according to their duration of the disease. Clinical examination as well as laboratory tests were done for participants. RESULTS: The frequency of TMJ involvement clinically was 15% in Group A and 40% in Group B. The most frequently observed clinical symptom was facial pain (25%), and the slightest symptom was clicking (2.5%) during mouth opening. There was a positive correlation between ESR, RF, CRP and anti-CCP and clinical sign and symptoms of TMJs in RA patients. An elevated ESR, RF CRP and anti-CCP may indicate the presence of TMJ complains in RA patients. The chronicity of RA affects the frequency of TMJ involvement clinically, patients with longer disease duration have more clinical symptoms of TMJs. An elevated level of ESR, RF, CRP and anti-CCP predict clinical symptoms of TMJs.

Evaluation of State-Led Surveillance of Neonatal Abstinence Syndrome - Six U.S. States, 2018-2021.

Opioid use disorder (OUD) is a significant public health problem in the United States, which affects children as well as adults. During 2010-2017, maternal opioid-related diagnoses increased approximately 130%, from 3.5 to 8.2 per 1,000 hospital deliveries, and neonatal abstinence syndrome (NAS) increased 83%, from 4.0 to 7.3 per 1,000 hospital deliveries (1). NAS, a withdrawal syndrome, can occur among infants following in utero exposure to opioids and other psychotropic substances (2). In 2018, a study of six states with mandated NAS case reporting for public health surveillance (2013-2017) found that mandated reporting helped quantify NAS incidence and guide programs and services (3). To review surveillance features and programmatic development in the same six states, a questionnaire and interview with state health department officials on postimplementation efforts were developed and implemented in 2021. All states reported ongoing challenges with initial case reporting, limited capacity to track social and developmental outcomes, and no requirement for long-term follow-up in state-mandated case reporting; only one state instituted health-related outcomes monitoring. The primary surveillance barrier beyond initial case reporting was lack of infrastructure. To serve identified needs of opioid- or other substance-exposed mother-infant dyads, state health departments reported programmatic successes expanding education and access to maternal medication for opioid use disorder (MOUD), community and provider education or support services, and partnerships with perinatal quality collaboratives. Development of additional infrastructure is needed for states aiming to advance NAS surveillance beyond initial case reporting.

Standardizing the Clinical Definition of Opioid Withdrawal in the Neonate.

OBJECTIVE: To standardize the clinical definition of opioid withdrawal in neonates to address challenges in clinical care, quality improvement, research, and public policy for this patient population. STUDY DESIGN: Between October and December 2020, we conducted 2 modified-Delphi panels using ExpertLens, a virtual platform for performing iterative expert engagement panels. Twenty clinical experts specializing in care for the substance-exposed mother-neonate dyad explored the necessity of key evidence-based clinical elements in defining opioid withdrawal in the neonate leading to a diagnosis of neonatal abstinence syndrome (NAS)/neonatal opioid withdrawal syndrome (NOWS). Expert consensus was assessed using descriptive statistics, the RAND/UCLA Appropriateness Method, and thematic analysis of participants' comments. RESULTS: Expert panels concluded the following were required for diagnosis: in utero exposure (known by history, not necessarily by toxicology testing) to opioids with or without the presence of other psychotropic substances, and the presence of at least two of the most common clinical signs characteristic of withdrawal (excessive crying, fragmented sleep, tremors, increased muscle tone, gastrointestinal dysfunction). CONCLUSIONS: Results indicate that both a known history of in utero opioid exposure and a distinct set of withdrawal signs are necessary to standardize a definition of neonatal withdrawal. Implementation of a standardized definition requires both patient engagement and a mother-neonate dyadic approach mindful of program and policy implications.

Informing the Development of a Standardized Clinical Definition of Neonatal Abstinence Syndrome: Protocol for a Modified-Delphi Expert Panel.

BACKGROUND: Neonatal abstinence syndrome (NAS) is a postnatal withdrawal syndrome that most commonly results from prenatal opioid exposure. Every 15 minutes, an infant is born in the United States with signs of NAS. The field lacks a standardized clinical definition of NAS, complicating discussions on programmatic and policy development to support opioid-exposed mothers and infants. OBJECTIVE: The goal of this paper is to describe a protocol for a systematic expert panel process to inform the development of a clinical definition of NAS. METHODS: We will conduct two three-round online modified-Delphi panels using the ExpertLens system and will follow the recommendations for Conducting and REporting of DElphi Studies (CREDES). One panel will focus on developing key components of a clinical definition of NAS, and the second panel will focus on neonatal opioid withdrawal syndrome (NOWS), which is a term that has come into use to differentiate opioid-exposed infants from infants exposed to other substances in utero. However, there is lack of agreement on the precise clinical definition of NOWS and how it is distinct from or overlaps with NAS. Each panel will complete two rating rounds and a discussion round using a similar protocol. We will analyze all rating data descriptively and determine the presence of agreement within and between the two panels. We will also perform thematic analysis of the qualitative comments to contextualize the panel findings. RESULTS: The panels were convened between October 29 and December 17, 2020. Their results were disseminated and discussed at a national conference on NAS that took place on March 17-18, 2021. CONCLUSIONS: A standardized clinical definition of NAS will help to better characterize NAS incidence and to design effective clinical, public health, and policy interventions to support opioid-exposed mother-infant dyads. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25387.

Definitions of neonatal abstinence syndrome in clinical studies of mothers and infants: an expert literature review.

Neonatal abstinence syndrome (NAS) results from discontinuation of in utero exposures to opioids/substances. The rising incidence of NAS has prompted an increased need for accurate research and public health data. To examine how NAS has been defined in clinical studies of opioid-exposed mothers and infants, a review process was developed based on the RAND/UCLA Appropriateness Method, yielding 888 abstracts. Per inclusion criteria, 57 abstracts underwent full-text review. To define NAS, studies cited using modified versions of the Finnegan NAS scoring tool (n = 21; 37%), ICD-9/10 coding (n = 17; 30%), original Finnegan tool (n = 16; 28%), Eat Sleep Console (n = 3; 5%), and Lipsitz (n = 3; 5%) tools, (3 cited 2+ tools). Most studies utilized subjective NAS scoring/assessment algorithms and neonatal coding as key elements defining NAS. While most cited opioid exposure as integral to their inclusion criteria, 26% did not. These approaches highlight the need for a more refined and standardized definition of NAS.

On Column Binding a Real-Time Biosensor for ß-lactam Antibiotics Quantification.

This work aimed to develop accurate, quick, and practical tools for the detection of residues of penicillin G antibiotic in biological and non-biological samples. The assays were developed based on the binding mechanism of ß-lactam to penicillin-binding proteins; samples of different concentrations of penicillin G were incubated with in vitro expressed 6X-Histidine-tagged soluble penicillin-binding protein (PBP2x*) of Streptococcus pneumoniae (S. pneumoniae), whereby penicillin G in samples specifically binds to PBP2x*. The fluorescent-labeled ß-lactam analogue Bocillin FL was used as a competent substrate, and two different routes estimated the amounts of the penicillin G. The first route was established based on the differences in the concentration of non-bounded Bocillin FL molecules within the reactions while using a real-time polymerase chain reaction (PCR)-based method for fluorescence detection. The second route depended on the amount of the relative intensity of Bocillin FL bounded to Soluble PBP-2x*, being run on sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-page), visualized by a ChemiDoc-It®2 Imager, and quantified based on the fluorescence affinity of the competent substrate. While both of the methods gave a broad range of linearity and high sensitivity, the on column based real-time method is fast, non-time consuming, and highly sensitive. The method identified traces of antibiotic in the range 0.01-0.2 nM in addition to higher accuracy in comparison to the SDS-based detection method, while the sensitivity of the SDS-based method ranged between 0.015 and 2 µM). Thus, the on column based real time assay is a fast novel method, which was developed for the first time based on the binding inhibition of a fluorescence competitor material and it can be adapted to screen traces of penicillin G in any biological and environmental samples.

Evaluation of State-Mandated Reporting of Neonatal Abstinence Syndrome - Six States, 2013-2017.

From 2004 to 2014, the incidence of neonatal abstinence syndrome (NAS) in the United States increased 433%, from 1.5 to 8.0 per 1,000 hospital births. The latest national data from 2014 indicate that one baby was born with signs of NAS every 15 minutes in the United States (1). NAS is a drug withdrawal syndrome that most commonly occurs among infants after in utero exposure to opioids, although other substances have also been associated with NAS. Prenatal opioid exposure has also been associated with poor fetal growth, preterm birth, stillbirth, and possible specific birth defects (2-5). NAS surveillance has often depended on hospital discharge data, which historically underestimate the incidence of NAS and are not available in real time, thus limiting states' ability to quickly direct public health resources (6,7). This evaluation focused on six states with state laws implementing required NAS case reporting for public health surveillance during 2013-2017 and reviews implementation of the laws, state officials' reports of data quality before and after laws were passed, and advantages and challenges of legally mandating NAS reporting for public health surveillance in the absence of a national case definition. Using standardized search terms in an online legal research database, laws in six states mandating reporting of NAS from medical facilities to state health departments (SHDs) or from SHDs to a state legislative body were identified. SHD officials in these six states completed a questionnaire followed by a semistructured telephone interview to clarify open-text responses from the questionnaire. Variability was found in the type and number of surveillance data elements reported and in how states used NAS surveillance data. Following implementation, five states with identified laws reported receiving NAS case reports within 30 days of diagnosis. Mandated NAS case reporting allowed SHDs to quantify the incidence of NAS in their states and to inform programs and services. This information might be useful to states considering implementing mandatory NAS surveillance.

The effects of acclimation to the United States and other demographic factors on responses to salt levels in foods: An examination utilizing face reader technology.

The aim of this study was to assess the role of extended time in the United States (as defined as a continuous period greater than two years; referred to hereafter as "US Acclimated"), as well as other demographic factors, on the level of net positive response of consumers to different salt levels in food samples. One hundred panelists were recruited, including 50 meeting our US acclimation criterion. Panelists assessed samples of potatoes with five different levels of salt concentrations, and the levels of their net positive responses were evaluated with FaceReader technology (Noldus). The data of our study showed a significant positive association between US Acclimated participants and the level of net positive response to samples with higher salt contents. This interaction remained statistically significant even when modeling the effects with consideration of race/ethnicity and gender. Another notable outcome was the unexpected significant interaction between gender and US acclimation in regards to evaluated positive response across all salt concentrations (US Acclimated females demonstrating substantially and significant higher levels of positive response than US Acclimated males). The association between living in the United States and showing more positive response to higher salt contents is consistent with many persistent characterizations of the eating habits in the United States, but it is not in fact well explained by the most recent data regarding the observed levels of average sodium consumption across worldwide geographical regions. The results of this study may be demonstrating evidence of underlying as-yet-unknown factors contributing to the responses of consumers to salt levels in foods. Further examination of these possible factors may well be warranted.

[Value of Doppler ultrasound for the assessment of carotid artery invasion by tumours of the upper aerodigestive tract]. / Intérêt de l'échographie Doppler dans l'évaluation de l'envahissement de l'artère carotidienne dans les tumeurs des voies aérodigestives supérieures.

The diagnosis of invasion of the carotid axis preoperatively is extremely helpful and determines the therapeutic approach as well as the prognosis for patients with tumours of the upper aerodigestive tract. A review of literature to refine the radiological choice between the different existing techniques is provided. It appears that echography gives excellent results.

Le diagnostic d'un envahissement de l'axe carotidien en période préopératoire est très utile et détermine l'attitude thérapeutique de même que le pronostic des patients présentant une tumeur des voies aérodigestives supérieures. A l'aide de cas cliniques, les différentes techniques d'imagerie ont été évaluées et une revue de littérature a été réalisée pour affiner le choix de la méthode radiologique. Il apparaît que l'échographie est particulièrement performante.

Incontinence and gait disturbance after intraventricular extension of intracerebral hemorrhage.

OBJECTIVE: We tested the hypothesis that intraventricular hemorrhage (IVH) is associated with incontinence and gait disturbance among survivors of intracerebral hemorrhage (ICH) at 3-month follow-ups. METHODS: The Genetic and Environmental Risk Factors for Hemorrhagic Stroke study was used as the discovery set. The Ethnic/Racial Variations of Intracerebral Hemorrhage study served as a replication set. Both studies performed prospective hot-pursuit recruitment of ICH cases with 3-month follow-up. Multivariable logistic regression analyses were computed to identify risk factors for incontinence and gait dysmobility at 3 months after ICH. RESULTS: The study population consisted of 307 ICH cases in the discovery set and 1,374 cases in the replication set. In the discovery set, we found that increasing IVH volume was associated with incontinence (odds ratio [OR] 1.50; 95% confidence interval [CI] 1.10-2.06) and dysmobility (OR 1.58; 95% CI 1.17-2.15) after controlling for ICH location, initial ICH volume, age, baseline modified Rankin Scale score, sex, and admission Glasgow Coma Scale score. In the replication set, increasing IVH volume was also associated with both incontinence (OR 1.42; 95% CI 1.27-1.60) and dysmobility (OR 1.40; 95% CI 1.24-1.57) after controlling for the same variables. CONCLUSION: ICH subjects with IVH extension are at an increased risk for developing incontinence and dysmobility after controlling for factors associated with severity and disability. This finding suggests a potential target to prevent or treat long-term disability after ICH with IVH.

Recalcitrant hypocalcemia after total thyroidectomy and bariatric surgery.

PROBLEM: Patients with Roux en Y gastric bypass (RYGBP) who undergo total thyroidectomy may be at increased risk for recalcitrant symptomatic hypocalcemia. METHODS: All patients who underwent total thyroidectomy with a history of preceding RYGBP from 2007 to 2012 were identified retrospectively. Cases were matched 2:1 for age, gender, and BMI to a control group undergoing total thyroidectomy without previous RYGBP during the same study period. RESULTS: Age and body mass index were equivalent between cases (n = 14) and controls (n = 23). A comparison between groups demonstrated that cases had a significantly higher incidence of symptomatic hypocalcemia resulting in paresthesia and tetany (38% vs. 0%; P <0 .01), received intravenous calcium more often (18% vs. 0%; P < 0.01), and had longer hospital stays (2.2 vs. 1.2 days, P = 0.02) than controls. CONCLUSIONS: Physicians and surgeons need to be aware of this complication and take measures to identify and prevent it, and patients should be informed. In this patient population, calcium levels should be closely monitored and early calcium and vitamin D spplementation should be initiated preemptively.

Prognostic value of FDG PET/CT in head and neck squamous cell carcinomas.

INTRODUCTION: The purpose of this study was to evaluate the use of (18)F-fluorodeoxyglucose positron emission tomography/computed tomography ((18)F-FDG PET/CT) to identify the presence of cervical lymph nodes metastases and extracapsular spread with histologic correlations in head and neck squamous cell carcinoma. METHODS: The medical records of 54 patients who underwent (18)F-FDG PET/CT for head and neck squamous cell carcinoma before surgery were reviewed. Receiver operating characteristic (ROC) analysis was performed to differentiate patients with cervical lymph node metastasis from those without lymph node metastasis. The same statistical analysis was done to differentiate cervical lymph nodes with extracapsular spread from those without extracapsular spread. RESULTS: Metastatic disease was diagnosed histologically in 49% (26 of 54) of the patients. Extracapsular spread was present in ten of the 54 patients (19%). When ROC curve analysis and maximum standardized uptake (SUVmax) values were used to detect cervical lymph node metastasis, the area under the ROC curve was 0.96 and the optimal cutoff value for SUVmax was 4.05 based on ROC curve analysis. The sensitivity and specificity of SUVmax for the detection of cervical lymph node metastasis using this cutoff point were 92% and 88%, respectively. When ROC curve analysis and SUVmax values were used in order to detect extracapsular spread, the area under the ROC curve was 0.86, and the optimal cutoff value for SUVmax was 4.15 based on ROC curve analysis. Using this cutoff value, the sensitivity and specificity of SUVmax for the detection of extracapsular spread were 83% and 88%, respectively. CONCLUSION: In our study, a median (18)F-FDG PET/CT SUVmax cutoff value of 4.15 was found to be related with cervical lymph node metastasis and extracapsular spread in patients with head and neck cancer.

Chemoradiation for advanced oral and (pharyngo) laryngeal carcinoma: single institution outcome analysis.

AIM: Chemoradiation ( CRT) is a valuable treatment option for(pharyngo)laryngeal squamous cell cancer and a palliative cure in advanced oral cancers. However, toxicity is scarcely reported. Therefore, efficacy, acute and toxic effects of chemoradiation for advanced head and neck squamous cell carcinomas were evaluated, using retrospective study. METHODS: Previously untreated patients with stage III-IV head and neck squamous cell carcinomas were included. Radiotherapy consisted of 70 Gy/7 weeks/35 fractions. All patients received concurrent Cisplatin 40 mg/m2 weekly. RESULTS: The most common acute toxic effects were dysphagia and mucositis. Dysphagia and xerostomia remained problematic during follow-up. Loco regional disease control was respectively 91% and 98% after 6 months. The median overall survival (calculating starting form the end of the treatment) was 33 months (range 0-111months). The 5-year disease specific survival was 41%. CONCLUSION: The results indicated that concurrent chemoradiotherapy for advanced head and neck squamous cell carcinoma is associated with high locoregional control and disease-specific survival. However, significant acute and long-term toxic effects occur, and organ preservation appears not necessarily equivalent to preservation of function in pharyngolaryngeal cancers.

Usefulness of neuromonitoring in thyroid surgery.

One of the most important complications during thyroid surgery is injury to the recurrent laryngeal nerve (RLN) which leads to dysfunction and palsy of the vocal folds. Adequate knowledge about the location of the RLN supported by neuromonitoring can help the operating surgeon to prevent this complication. Visualization of the nerve alone seems not enough. An estimation of the function of the RLN is very important. Recently, the use of neuromonitoring has been increasingly employed to predict and document nerve function at the end of thyroidectomy. The aim of the study was to verify the usefulness of neuromonitoring in identifying the recurrent laryngeal nerve and to predict postoperative outcome in patients undergoing thyroid surgery for different indications. Between March 2009 and October 2010, 91 patients (26 men, 65 women; mean age 53 (range 26-83) underwent thyroidectomy. Intraoperative neuromonitoring (IONM) was registered for 91 patients. Eighty-four total thyroidectomies and seven lobectomies were performed with IONM. Eight unilateral postoperative transient paresis were identified without any permanent paralysis. Intraoperative neuromonitoring has an excellent specificity and negative predictive value in which an unchanged positive signal is highly predictive of intact nerve function. Intraoperative neuromonitoring during thyroid surgery is a reliable tool for early recurrent laryngeal nerve localization and identification, certainly in complicated thyroid operations. The probability is high for correctly predicting an intact postoperative nerve function by neuromonitoring.