Latent class analysis of migraine associated vestibular-auditory symptoms.

OBJECTIVE: This study aimed to identify the potential subgroups of migraines based on the patterns of migraine associated symptoms, vestibular and auditory symptoms using latent class analysis and to explore their characteristics. METHOD: A total of 555 patients with migraine participated in the study. Symptoms such as nausea, vomiting, photophobia, phonophobia, osmophobia, visual symptoms, vestibular symptoms (dizziness, vertigo), and auditory symptoms (tinnitus, hearing loss, aural fullness) were assessed. Latent class analysis was performed to identify subgroups of migraines. Covariates such as gender, age of migraine onset, frequency of migraine attacks per month, and family history were also considered. RESULTS: The analysis revealed four latent classes: the Prominent Vestibular; Prominent Nausea; Presenting Symptoms but not prominent or dominant; and Sensory Hypersensitivity groups. Various covariates, such as gender, age of migraine onset, and frequency of migraine attacks, demonstrated significant differences among the four groups. The Sensory Hypersensitivity group showed the presence of multiple sensory symptoms, earlier age of migraine onset, and higher proportion of females. The Prominent Vestibular group had the highest probability of dizziness or vertigo but lacked the presence of auditory symptoms. The Prominent Nausea group exhibited prominent nausea. The Presenting Symptoms but not prominent or dominant group comprised individuals with the highest migraine attacks per month and proportion of chronic migraine. CONCLUSION: This study identifies four subgroups of migraines based on the patterns of symptoms. The findings suggest potential different but overlapped mechanisms behind the vestibular and auditory symptoms of migraine. Considering the different patterns of migraine-related symptoms may provide deeper insights for patients' prognosis and clinical decision-making.

Gastric Alimetry® Testing and Healthcare Economic Analysis in Nausea and Vomiting Syndromes.

BACKGROUND: Chronic nausea and vomiting syndromes (CNVS), gastroparesis and functional dyspepsia (FD) are complex disorders. Body Surface Gastric Mapping (BSGM), a new test of gastric function, using Gastric Alimetry® (Alimetry, New Zealand) may be useful for de-escalating healthcare utilisation. This study aimed to define healthcare costs and estimate health economic impacts of implementing this test in patients with chronic gastroduodenal symptoms. METHODS: Consecutive patients at a tertiary referral centre evaluated with Gastric Alimetry were included. Frequency and cost data relating to medical investigations, hospital and outpatient presentations were evaluated. Costs of healthcare utilisation were calculated, and the potential cost savings of implementing Gastric Alimetry within a diagnostic decision-tree model were estimated. RESULTS: Overall, 31 consecutive patients (mean age 36.1 years; 83.9% female; predominant symptoms: nausea [83.9%], pain [61.3%], vomiting [67.7%] and bloating [35.5%]) completed Gastric Alimetry testing. Repeat gastroscopy and abdominal CT rates were 29% (8/28) and 85% (11/13), respectively. Gastric Alimetry testing identified spectral abnormalities in 45.2% of patients, and symptom profiling classified a further 29.1% of patients. Median annualised cost difference after test introduction was NZ$-12,032. Estimated reductions in investigation-related costs when incorporating Gastric Alimetry into the diagnostic workflow model were approximately NZ$1,300 per patient. CONCLUSIONS: Healthcare utilisation and confirmatory testing rates remain high in nausea and vomiting syndromes. This study presents real-world data, together with a decision-tree analysis, showing Gastric Alimetry can streamline clinical care pathways, resulting in reduced healthcare utilisation and cost.

Diagnosis and Management of Cyclic Vomiting Syndrome: A Critical Review.

Cyclic vomiting syndrome (CVS) is a chronic disorder of gut-brain interaction characterized by recurrent disabling episodes of nausea, vomiting, and abdominal pain. CVS affects both children and adults with a prevalence of approximately 2% in the United States. CVS is more common in female individuals and affects all races. The pathophysiology of CVS is unknown and a combination of genetic, environmental, autonomic, and neurohormonal factors is believed to play a role. CVS is also closely associated with migraine headaches and likely have a shared pathophysiology. The diagnosis of CVS is based on the Rome criteria, and minimal recommended testing includes an upper endoscopy and imaging studies of the abdomen. CVS is frequently associated with anxiety, depression, and autonomic dysfunction. Patients with CVS commonly use cannabis therapeutically for symptom relief. By contrast, cannabinoid hyperemesis syndrome is believed to be a subset of CVS with chronic heavy cannabis use leading to hyperemesis. Due to the recalcitrant nature of the illness, patients often visit the emergency department and are hospitalized for acute CVS flares. Guidelines on the management of CVS recommend a biopsychosocial approach. Prophylactic therapy consists of tricyclic antidepressants (amitriptyline), antiepileptics (topiramate), and aprepitant in refractory patients. Abortive therapy consists of triptans, antiemetics (ondansetron), and sedation. Treatment of comorbid conditions is extremely important to improve overall patient outcomes. CVS has a significant negative impact on patients, families, and the healthcare system, and future research to understand its pathophysiology and develop targeted therapies is needed.

Waterpipe Tobacco (Hookah) Use in Pregnancy: Associations with Nausea and Vomiting of Pregnancy.

OBJECTIVE: Waterpipe tobacco (WPT) use is common among reproductive age patients and is often perceived as safer than cigarette use. Prior studies have shown a decrease in nausea and vomiting symptoms among pregnant women who use cigarettes, but no studies to date have examined these symptoms in pregnant women who use WPT. This study was aimed to investigate the extent of symptoms of nausea/vomiting of pregnancy among participants who self-reported WPT use during pregnancy. STUDY DESIGN: Secondary analysis of a prospective cohort study examining WPT use during pregnancy. Participants completed the Pregnancy-Unique Quantification of Emesis (PUQE) during first and third trimesters. Medical conditions were determined by medical record review. Participants were evaluated by sole WPT use versus dual/polysubstance WPT use and frequency of WPT use. RESULTS: Ninety-nine (100%) participants completed the PUQE questionnaire during first trimester and 82 (82.8%) completed the PUQE during third trimester. Almost all (91.9%) participants reported moderate nausea/vomiting symptoms at both assessments. There was no difference in frequency of WPT use in pregnancy or rates of dual/polysubstance WPT use in participants with all levels of the PUQE questionnaire. There was also no difference in rates of WPT use or PUQE scores between sole WPT users and dual/polysubstance users. When comparing low and high WPT use, those who were in the higher frequency use group had higher waterpipe dependence scale scores (7.2 vs. 5.3, p < 0.02). With regard to maternal medical comorbidities, the only difference between groups was that sole WPT users were more likely to have a diagnosis of asthma than dual/polysubstance users (36.8 vs. 14.9%, p < 0.02). CONCLUSION: There were no differences in symptoms of nausea and vomiting of pregnancy or medical conditions in pregnant women who use WPT with any frequency during pregnancy. However, sole WPT users had higher rates of asthma than dual/polysubstance WPT users. KEY POINTS: · Waterpipe tobacco use is one of the most common forms of tobacco use among reproductive age patients.. · Waterpipe tobacco use was not associated with any changes in nausea/vomiting of pregnancy symptoms.. · Future research on the use of waterpipe tobacco in pregnancy can aid in public health responses..

Recalling the severity of nausea and vomiting of pregnancy - a study using Pregnancy-Unique Quantification of Emesis Questionnaire.

The accuracy of the recall of the severity of nausea and vomiting of pregnancy (NVP) with Pregnancy-Unique Quantification of Emesis (PUQE) questionnaire has been questioned. We aimed to compare PUQE scores of women recalling the worst episode of NVP of their current pregnancy in different gestational weeks (gwks). Total of 2343 pregnant women (gwks 7-40) were recruited. Four groups were formed according to the gwks at reply: ≤16 gwks (n = 554), ≤20 gwks (n = 1209), >20 gwks (n = 1134) and ≥24 gwks (n = 495). PUQE scores were similar between the groups. Consequently, consistency of PUQE scores across the groups endorses the useability of the PUQE questionnaire in retrospective assessment of the overall severity of NVP in different gwks, regardless of passing of the peak NVP symptoms.Impact statementWhat is already known on this subject? Retrospective evaluation of the severity of nausea and vomiting of pregnancy (NVP) has been argued to be disposed to recall bias. Structured Pregnancy-Unique Quantification of Emesis (PUQE) questionnaire is a validated tool for assessing the severity of NVP.What do the results of this study add? When the women recalled the most severe NVP symptoms of their current pregnancy, no differences in the PUQE scores were found despite different gestational weeks at reply. Of distinct PUQE questions, women answering in early pregnancy reported longer duration of nausea than women answering in late pregnancy, but other questions were rated similarly.What the implications are of these findings for clinical practice and/or further research? Our aim was to compare the PUQE scores between the women who filled in the PUQE questionnaire in early or in late pregnancy, instructed to recall their worst symptoms in their current pregnancy. As there were no differences between the groups in total PUQE scores, our results support the application of PUQE questionnaire to assess the severity of NVP during pregnancy not only concurrent to the peak symptoms but also retrospectively.

[Analysis of the clinical characteristics and misdiagnosis of area postrema syndrome manifesting as intractable nausea, vomiting, and hiccups in neuromyelitis optica spectrum disorders].

Objective: To investigate the misdiagnosis of area postrema syndrome (APS) manifesting as intractable nausea, vomiting and hiccups in neuromyelitis optic spectrum disease (NMOSD) and reduce the risk of misdiagnosis. Methods: We retrospectively analyzed data from NMOSD patients attending the Department of Neurology at the First Medical Center of PLA General Hospital between January 2019 and July 2021. SPSS25.0 was then used to analyze the manifestations, misdiagnosis, and mistreatment of APS. Results: A total of 207 patients with NMOSD were included, including 21 males and 186 females. The mean age of onset was 39±15 years (range: 5-72 years). The proportion of patients who were positive for serum aquaporin 4 antibody was 82.6% (171/207). In total, 35.7% (74/207) of the NMOSD patients experienced APS during the disease course; of these patients, 70.3% (52/74) had APS as the first symptom and 29.7% (22/74) had APS as a secondary symptom. The misdiagnosis rates for these conditions were 90.4% (47/52) and 50.0% (11/22), respectively. As the first symptom, 19.2% (10/52) of patients during APS presented only with intractable nausea, vomiting and hiccups; 80.8% (42/52) of patients experienced other neurological symptoms. The Departments of Gastroenterology and General Medicine were the departments that most frequently made the first diagnosis of APS, accounting for 54.1% and 17.6% of patients, respectively. The most common misdiagnoses related to diseases of the digestive system and the median duration of misdiagnosis was 37 days. Conclusions: APS is a common symptom of NMOSD and is associated with a high rate of misdiagnosis. Other concomitant symptoms often occur with APS. Gaining an increased awareness of this disease/syndrome, obtaining a detailed patient history, and performing physical examinations are essential if we are to reduce and avoid misdiagnosis.

Multichannel magnetogastrogram: a clinical marker for pediatric chronic nausea.

Chronic nausea is a widespread functional disease in children with numerous comorbidities. High-resolution electrogastrogram (HR-EGG) has shown sufficient sensitivity as a noninvasive clinical marker to objectively detect distinct gastric slow wave properties in children with functional nausea. We hypothesized that the increased precision of magnetogastrogram (MGG) slow wave recordings could provide supplementary information not evident on HR-EGG. We evaluated simultaneous pre- and postprandial MGG and HR-EGG recordings in pediatric patients with chronic nausea and healthy asymptomatic subjects, while also measuring nausea intensity and nausea severity. We found significant reductions in postprandial dominant frequency and normogastric power, and higher levels of postprandial bradygastric power in patients with nausea in both MGG and HR-EGG. MGG also detected significantly lower preprandial normogastric power in patients. A significant difference in the mean preprandial gastric slow wave propagation direction was observed in patients as compared with controls in both MGG (control: 180 ± 61°, patient: 34 ±72°; P < 0.05) and HR-EGG (control: 240 ± 39°, patient: 180 ± 46°; P < 0.05). Patients also showed a significant change in the mean slow wave direction between pre- and postprandial periods in MGG (P < 0.05). No statistical differences were observed in propagation speed between healthy subjects and patients in either MGG or HR-EGG pre/postprandial periods. The use of MGG and/or HR-EGG represents an opportunity to assess noninvasively the effects of chronic nausea on gastric slow wave activity. MGG data may offer the opportunity for further refinement of the more portable and economical HR-EGG in future machine-learning approaches for functional nausea.NEW & NOTEWORTHY Pediatric chronic nausea is a difficult-to-measure subjective complaint that requires objective diagnosis, clinical assessment, and individualized treatment plans. Our study demonstrates that multichannel MGG used in conjunction with custom HR-EGG detects key pathological signatures of functional nausea in children. This quantifiable measure may allow more personalized diagnosis and treatment in addition to minimizing the cost and potential radiation associated with current diagnostic approaches.

Use of Cluster Analysis to Identify Subtypes of Pediatric Functional Nausea.

OBJECTIVE: The aim of the study was to evaluate whether there are clinical subtypes in children with functional nausea based on comorbidities and responses to the Nausea Profile questionnaire. METHODS: Patients from the Neurointestinal and Motility Program clinical registry at Lurie Children's Hospital were included if they met Rome IV criteria for functional nausea. Patients completed the Nausea Profile, a multidimensional measure of nausea with gastrointestinal, emotional, and somatic subscales. Comorbidities were assessed by chart review and self-report measures. Latent class analysis was used to identify patient groups based on comorbidities. To assess if model-identified groups were predictive of differences in nausea quality, Nausea Profile subscale means were compared between groups and used to predict group membership. Conversely, k-means analysis was used to divide the sample into groups based upon Nausea Profile subscale scores, to determine if identified groups had different comorbidities. RESULTS: Seventy-two patients (n = 53 girls) with a mean age (±SD) 14.5 ±â€Š2.9 were included. Two clinical subtypes were identified based on comorbidities, with responses on the emotional subscale of the Nausea Profile predicting group membership (P < 0.04). When patients were grouped by nausea quality, the resulting clusters differed on psychiatric comorbidities (P < 0.001). CONCLUSIONS: Our findings support the existence of nausea subtypes within the broad diagnosis of functional nausea. One such subtype is an emotional predominant nausea supporting the notion that anxiety and depression constitute a subset of patients with nausea. Thus, patients may benefit from a treatment approach that integrates both GI assessment and psychiatric support in their care.

Psychometric properties of the Pregnancy-Unique Quantification of Emesis (PUQE-24) Scale.

The objective of this study is to conduct a reliability and validity study of the Turkish version of the 'Pregnancy-Unique Quantification of Emesis (PUQE-24)' in pregnant women. In the Turkish version, Cronbach's alpha coefficient was 0.75, and the item-total score correlations were between 0.75 and 0.85. In the exploratory factor analysis it was determined that the scale had a single-factor structure explaining 65.968% of the total variance. The factor load values of the scale were found to be between 0.776 and 0.831. The Turkish version of scale was found to be a valid and reliable measurement in pregnant women.IMPACT STATEMENTWhat is already known on this subject? Complaints of nausea and vomiting during pregnancy are common. Therefore, it is important to evaluate nausea and vomiting during pregnancy with a valid and reliable tool. Pregnancy-Unique Quantification of Emesis (PUQE-24) is a reliable tool for assessing the severity of nausea and vomiting symptoms. The original scale was translated into various languages, its validity and reliability were made in some countries and it was used in many studies.What do the results of this study add? The present study showed that Pregnancy-Unique Quantification of Emesis (PUQE-24) is valid and reliable for Turkish pregnant women. Thus, the scale can be used as a reliable tool in Turkish population.What are the implications of these findings for clinical practice and/or further research? As a result of this study, Pregnancy-Unique Quantification of Emesis (PUQE-24) can be used as a validated tool for the Turkish population during clinical practice by healthcare professionals and researchers, who are evaluating nausea and vomiting during pregnancy. In future studies, it can be used as an objective assessment tool to determine whether an intervention is needed for nausea and vomiting during pregnancy or to reveal whether the intervention has worked.

Developing the Nausea and Vomiting Thermometer Scale in children with cancer.

BACKGROUND: This study aimed to develop the Nausea and Vomiting Thermometer Scale (NVTS) in children with cancer. METHODS: This methodological study was conducted on 250 children with cancer at the research and training university hospital in Turkey between September 2019 and January 2020. The t-test, the ROC analysis, the Diagnostic index, and the Youden index were used for determining the scale of the cutting point. The regression analysis, the intra-class correlation coefficient, and the BlandAltman analysis were used for the data analysis. RESULTS: The scale-level content validity index was .94, which was coherent. As a result of the ROC analysis, the cut-off point was determined as three points. The NVTS showed good reliability, with an intra-class correlation coefficient of .99. In the linear regression analysis, a model was created for chemotherapy drugs, nausea and vomiting type, vomiting status, and the number of children with cancer who vomited explained 44.9% of their nausea and vomiting status. The results of the Bland-Altman analysis showed that the correlation coefficient between the differences and the means was insignificant.

Validation of the caregiver Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events measure.

BACKGROUND: Despite improvements in survival rates, cancer treatments have significant side effects that affect the quality of life of children and their families. When an ill child cannot self-report symptoms (eg, he or she is too ill), caregiver (parent) reporting becomes critical. This study evaluates the validity and reliability of the caregiver-reported Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE [Caregiver]) measure. METHODS: A diverse sample of caregivers with children receiving treatment at 9 oncology centers completed the Ped-PRO-CTCAE [Caregiver] measure, the Patient-Reported Outcomes Measurement Information System® (PROMIS® ) Parent Proxy measures, the Lansky Play-Performance Scale (PPS), medication use questions, and Global Impressions of Change (GIC). Construct validity (including convergent, discriminant, and known groups validity and responsiveness over time) and reliability (stability) were examined. RESULTS: A majority of the 473 caregivers were female (85%), non-Hispanic White (61%), and married (75%). Symptoms assessed with the Ped-PRO-CTCAE [Caregiver] and PROMIS Parent Proxy measures were strongly correlated (e.g., r for pain = 0.78; r for fatigue = 0.78; and r for depression = 0.83). Most of the Ped-PRO-CTCAE [Caregiver] item mean scores distinguished among PPS function levels and between children who did take medications for symptom control and children who did not. Changes in Ped-PRO-CTCAE [Caregiver] item mean scores were responsive to GIC over time. Test-retest evaluation found moderate to high agreement (57.8%-93.3%) over time. CONCLUSIONS: This study found strong evidence for the convergent and discriminant validity, known groups validity, responsiveness, and stability of the Ped-PRO-CTCAE [Caregiver] measure in a large and diverse sample of caregivers. The caregiver perspective provides a valuable and unique insight into the experiences of children and adolescents undergoing cancer treatment. LAY SUMMARY: Despite advances in cancer treatments, children and adolescents continue to suffer from treatment side effects, including pain, nausea, fatigue, and emotional distress, that can adversely affect quality of life for children and their families. Although it is best for children to report how they are feeling, there are times when a child may be too young or too ill to self-report. This study provides critical evidence for a new type of questionnaire that allows the caregiver or parent to report accurately what the child is experiencing. This measure can be used to improve adverse event reporting and child cancer care.

Clinical Characteristics of COVID-19 Patients With Gastrointestinal Symptoms in Northern Italy: A Single-Center Cohort Study.

INTRODUCTION: The most typical presentation of COVID-19 is an acute respiratory syndrome whose most common symptoms include fever, cough, and dyspnea. However, gastrointestinal symptoms, such as diarrhea and nausea/vomiting, are increasingly reported in patients affected by COVID-19. This study aimed to describe the prevalence and time of onset of gastrointestinal symptoms in patients affected by COVID-19 and to find potential associations between gastrointestinal symptoms and clinical outcomes. METHODS: We performed a prospective single-center cohort study, enrolling patients who received diagnosis of COVID-19 at our institution between March 23, 2020, and April 5, 2020. We collected patient demographics and medical history, laboratory data, and clinical outcomes. Furthermore, we used a specifically designed questionnaire, administered to patients at time of diagnosis, to obtain data on the presence and time of onset of fever, typical respiratory symptoms, gastrointestinal symptoms, and other symptoms (fatigue, headache, myalgia/arthralgia, anosmia, ageusia/dysgeusia, sore throat, and ocular symptoms). RESULTS: In our cohort, 138 (69%) of 190 patients showed at least 1 gastrointestinal symptom at diagnosis; if excluding hyporexia/anorexia, 93 patients (48.9%) showed at least 1 gastrointestinal symptom. Gastrointestinal symptoms, in particular diarrhea, were associated with a lower mortality. At multivariate analysis, diarrhea was confirmed as independent predictive factor of lower mortality. DISCUSSION: Gastrointestinal symptoms are very frequent in patients with COVID-19 and may be associated with a better prognosis. These data suggest that, in some patients, the gastrointestinal tract may be more involved than the respiratory system in severe acute respiratory syndrome coronavirus 2 infection, and this could account for the less severe course of disease.

The preferences of women with ovarian cancer for oral versus intravenous recurrence regimens.

OBJECTIVE: To assess preferences of women with ovarian cancer regarding features of available anti-cancer regimens for platinum-resistant, biomarker-positive disease, with an emphasis on oral PARP inhibitor and standard intravenous (IV) chemotherapy regimens. METHODS: A discrete-choice-experiment preferences survey was designed, tested, and administered to women with ovarian cancer, with 11 pairs of treatment profiles defined using seven attributes (levels/ranges): regimen (oral daily, IV weekly, IV monthly); probability of progression-free (PFS) at 6 months (40%-60%); probability of PFS at 2 years (10%-20%); nausea (none, moderate); peripheral neuropathy (none, mild, moderate); memory problems (none, mild); and total out-of-pocket cost ($0 to $10,000). RESULTS: Of 123 participants, 38% had experienced recurrence, 25% were currently receiving chemotherapy, and 18% were currently taking a PARP inhibitor. Given attributes and levels, the relative importance weights (sum 100) were: 2-year PFS, 28; cost, 27; 6-month PFS, 19; neuropathy,14; memory problems, nausea, and regimen, all ≤5. To accept moderate neuropathy, participants required a 49% (versus 40%) chance of PFS at 6 months or 14% (versus 10%) chance at 2 years. Given a 3-way choice where PFS and cost were equal, 49% preferred a monthly IV regimen causing mild memory problems, 47% preferred an oral regimen causing moderate nausea, and 4% preferred a weekly IV regimen causing mild memory and mild neuropathy. CONCLUSIONS: These findings challenge the assumption that oral anti-cancer therapies are universally preferred by patients and demonstrate that there is no "one size fits all" regimen that is preferable to women with ovarian cancer when considering recurrence treatment regimens.

The Management of Nausea and Vomiting Not Related to Anticancer Therapy in Patients with Cancer.

OPINION STATEMENT: In cancer patients, the management of nausea and vomiting that is not directly related to treatment is challenging. Much current practice is based on expert opinion and anecdote. Fortunately, over recent years, a number of quality trials have been undertaken to strengthen the evidence base that guides the care of our patients with these distressing symptoms. Much is still unknown however. In this article, we present the latest literature that addresses some of the outstanding issues.

Video-nystagmographic evidence in more than 700 consecutive cases of road traffic whiplash injury.

PURPOSE: Whiplash injury is a frequent traumatic lesion occurring mainly in road accidents, which may also cause dizziness severe enough to impact everyday life. Vestibular examination is routinely performed on these patients, although the role of the neuro-otologist is still not clearly defined. The main endpoint of this study was to describe the videonystagmography (VNG) evidence in a large cohort of patients who underwent road traffic whiplash injury. METHODS: 717 consecutive patients who reported whiplash-associated disorders due to a road traffic accident underwent clinical examination and VNG. RESULTS: Patients with saccadic test latency anomalies more frequently complained of vertigo, nausea and cochlear symptoms after trauma (p = 0.031, 0.028 and 0.006), while patients with bilateral vestibular weakness at caloric stimulation more often displayed neck pain after trauma (p = 0.005). Patients complaining of positional or cochlear symptoms or with accuracy anomalies at the saccadic test were significantly older than those with no positional, no cochlear symptoms and without accuracy anomalies (p = 0.022, p = 0.034 and p = 0.001). Patients with bilateral vestibular hypofunction were significantly younger (p < 0.001). CONCLUSIONS: VNG evidence, particularly vestibular function and saccadic tests, may be related to damage in the cervical region due to whiplash trauma. These findings suggest that neuro-otologic examination may play a role in properly identifying those who suffer damage caused by whiplash trauma, and in characterizing the severity and prognosis of whiplash-associated disorders.

Children with Functional Nausea-Comorbidities outside the Gastrointestinal Tract.

OBJECTIVE: To detail common comorbidities and procedures performed to evaluate functional nausea in children. STUDY DESIGN: In total, 63 children age 7-18 years seen in a tertiary care pediatric clinic who met Rome IV criteria for functional nausea prospectively completed an Intake Questionnaire, the Pediatric and Parent-Proxy PROMIS-25 Profile v 2.0, the Pediatric and Parent-Proxy Pediatric Sleep Disturbance-Short Form 4a, and the COMPASS 31 orthostatic intolerance scale to assess comorbidities. Medical records were reviewed for diagnostic tests performed to evaluate nausea and for additional comorbidities. Summary statistics were used to determine the most common comorbidities and diagnostic yield of the procedures. Intraclass correlation coefficients assessed agreement between parent and child reports on the PROMIS scales. RESULTS: Patients with functional nausea experienced multisystem comorbidities. A majority reported abdominal pain, headache, orthostatic intolerance, fatigue, disturbed sleep, anxiety, constipation, allergies, and vomiting. Agreement between parent-proxy and child report of symptoms on PROMIS scales was good to excellent (intraclass correlation coefficients = .78-.83; all P < .001). Patients underwent extensive diagnostic testing: 96 endoscopic procedures, 199 radiologic tests, and 4 cholecystectomies. Most of the procedures were not diagnostically informative. CONCLUSIONS: Children with functional nausea have comorbidities outside the gastrointestinal tract that warrant evaluation. Gastrointestinal diagnostic tests were of low-yield in identifying a cause. Understanding the relationship with comorbidities may provide insight into etiologies for the nausea and define clinical phenotypes to better tailor care.

The neuroinvasive potential of SARS-CoV2 may play a role in the respiratory failure of COVID-19 patients.

Following the severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV), another highly pathogenic coronavirus named SARS-CoV-2 (previously known as 2019-nCoV) emerged in December 2019 in Wuhan, China, and rapidly spreads around the world. This virus shares highly homological sequence with SARS-CoV, and causes acute, highly lethal pneumonia coronavirus disease 2019 (COVID-19) with clinical symptoms similar to those reported for SARS-CoV and MERS-CoV. The most characteristic symptom of patients with COVID-19 is respiratory distress, and most of the patients admitted to the intensive care could not breathe spontaneously. Additionally, some patients with COVID-19 also showed neurologic signs, such as headache, nausea, and vomiting. Increasing evidence shows that coronaviruses are not always confined to the respiratory tract and that they may also invade the central nervous system inducing neurological diseases. The infection of SARS-CoV has been reported in the brains from both patients and experimental animals, where the brainstem was heavily infected. Furthermore, some coronaviruses have been demonstrated able to spread via a synapse-connected route to the medullary cardiorespiratory center from the mechanoreceptors and chemoreceptors in the lung and lower respiratory airways. Considering the high similarity between SARS-CoV and SARS-CoV2, it remains to make clear whether the potential invasion of SARS-CoV2 is partially responsible for the acute respiratory failure of patients with COVID-19. Awareness of this may have a guiding significance for the prevention and treatment of the SARS-CoV-2-induced respiratory failure.

The emergence of a novel coronavirus (SARS-CoV-2) disease and their neuroinvasive propensity may affect in COVID-19 patients.

An outbreak of a novel coronavirus (SARS-CoV-2) infection has recently emerged and rapidly spreading in humans causing a significant threat to international health and the economy. Rapid assessment and warning are crucial for an outbreak analysis in response to serious public health. SARS-CoV-2 shares highly homological sequences with SARS-CoVs causing highly lethal pneumonia with respiratory distress and clinical symptoms similar to those reported for SARS-CoV and MERS-CoV infections. Notably, some COVID-19 patients also expressed neurologic signs like nausea, headache, and vomiting. Several studies have reported that coronaviruses are not only causing respiratory illness but also invade the central nervous system through a synapse-connected route. SARS-CoV infections are reported in both patients and experimental animals' brains. Interestingly, some COVID-19 patients have shown the presence of SARS-CoV-2 virus in their cerebrospinal fluid. Considering the similarities between SARS-CoV and SARS-CoV-2 in various aspects, it remains to clarify whether the potent invasion of SARS-CoV-2 may affect in COVID-19 patients. All these indicate that more detailed criteria are needed for the treatment and the prevention of SARS-CoV-2 infected patients. In the absence of potential interventions for COVID-19, there is an urgent need for an alternative strategy to control the spread of this disease.

Neratinib in patients with HER2-mutant, metastatic cervical cancer: Findings from the phase 2 SUMMIT basket trial.

OBJECTIVE: Somatic HER2 mutations occur in ~5% of cervical cancers and are considered oncogenic and associated with poor prognosis. Neratinib, an irreversible pan-HER tyrosine kinase inhibitor, is active in multiple HER2-mutant cancers. SUMMIT is a phase II basket trial investigating the efficacy and safety of neratinib in solid tumors. METHODS: Patients with HER2-mutant, persistent, metastatic/recurrent cervical cancer with disease progression after platinum-based treatment for advanced/recurrent disease received oral neratinib 240 mg/day with mandatory loperamide prophylaxis during cycle 1. The primary endpoint was confirmed objective response rate (ORR). Secondary endpoints included: response duration (DOR); clinical benefit rate (CBR); progression-free survival (PFS); overall survival (OS); safety. RESULTS: Sixteen eligible patients were enrolled; 10 (62.5%) had endocervical adenocarcinoma. The most common HER2 mutation was S310F (63% of patients). Three of 12 RECIST-measurable patients had confirmed partial responses (ORR 25%; 95%CI 5.5-57.2%); 3 had stable disease ≥16 weeks (CBR 50%; 95%CI 21.1-78.9%). DOR for responders were 5.6, 5.9, and 12.3 months. Median PFS was 7.0 months (95%CI 0.7-18.3 months); median OS was 16.8 months (95%CI 4.1-NE months). Diarrhea (75%), nausea (44%), and decreased appetite (38%) were the most common adverse events. One patient (6%) reported grade 3 diarrhea. There were no grade 4 events, and no diarrhea-related treatment discontinuations. CONCLUSIONS: Neratinib monotherapy showed evidence of activity in heavily pretreated patients with HER2-mutant cervical cancer, with no new safety signals. Given the few effective options for cervical cancer after platinum-based therapy failure, neratinib warrants further investigation in this molecularly defined patient population. TRIAL REGISTRATION NUMBER: NCT01953926 (ClinicalTrials.gov), 2013-002872-42 (EudraCT).

Most Bothersome Symptom in Persons With Migraine: Results From the Migraine in America Symptoms and Treatment (MAST) Study.

OBJECTIVES: The objectives of this study were to determine the rates of nausea, phonophobia, and photophobia reported overall and as the most bothersome symptom (MBS) in individuals with migraine and to identify individual characteristics associated with each of the 3 candidate MBSs. BACKGROUND: The MBS has emerged as an important coprimary efficacy endpoint in clinical trials of acute treatments for migraine, as recommended by the Food and Drug Administration. The current understanding of how persons with migraine designate an associated symptom as the most bothersome has been assessed primarily in the context of randomized trials. METHODS: Respondents (n = 95,821) in the cross-sectional, observational Migraine in America Symptoms and Treatment (MAST) study were adults (aged ≥18 years) recruited from a US nationwide online research panel. A validated diagnostic screener identified 15,133 individuals who met modified International Classification of Headache Disorders (ICHD)-3 beta criteria for migraine and reported at least 1 monthly headache day (MHD) over the previous 3 months. The survey ascertained sociodemographic variables, headache-related disability, MHDs, cutaneous allodynia, medication overuse, a migraine symptom severity score, pain interference, noncephalic pain, anxiety and depression symptoms, visual aura over the previous year, and acute treatment optimization. The current analysis is based on respondents who also completed a 6-month follow-up assessment that included questions about their most bothersome headache symptom. RESULTS: A total of 7518 respondents completed the 6-month follow-up, and 6045 met inclusion criteria and were included in the analysis. The mean age of respondents was 47 (SD 13.4) years, 76.0% (4596/6045) were women, and 84.8% (5103/6017) were white. Among all respondents, 64.9% reported all 3 migraine symptoms. The MBS was photophobia in 49.1% (2967/6045), nausea in 28.1% (1697/6045), and phonophobia in 22.8% (1381/6045). Respondents reporting photophobia as the MBS were more likely to be men, to be obese, and to report visual aura. Those reporting nausea as the MBS were more likely to be women, to have lower incomes, and to report lower levels of treatment optimization. Respondents reporting phonophobia as the MBS were more likely to have cutaneous allodynia and less likely to have visual aura. CONCLUSION: Most people with migraine in the MAST observational study reported all 3 cardinal symptoms of nausea, photophobia, and phonophobia. As in clinical trials, the most common MBS was photophobia. Patient profiles differed among the groups defined by their MBS.