The Relevance of Insomnia in the Diagnosis of Perinatal Depression: Validation of the Italian Version of the Insomnia Symptom Questionnaire

Background. Sleep disorders are common in perinatal women and may underlie or trigger anxiety and depression. We aimed to translate and validate and evaluate the psychometric properties of the Italian version of the Insomnia Symptom Questionnaire (ISQ), in a sample of women during late pregnancy and 6-months postpartum according to the DSM-5 criteria. Methods. The ISQ was administered to 292 women prenatally along with other measures of sleep quality, depression, and anxiety, to examine its construct and convergent validity. Women were readministered the ISQ six months postdelivery to assess test–retest reliability. Women were divided into DSM-5 No-Insomnia (N = 253) and Insomnia (N = 39) groups. Results. The insomnia group had received more psychopharmacotherapy, had more psychiatric family history, increased rates of medically assisted reproduction, of past perinatal psychiatric disorders, and scored higher on almost all TEMPS-A dimensions, on the EPDS, HCL-32, PSQI, and on ISQ prenatally and postnatally. ISQ scores correlated with all scales, indicating adequate convergent and discriminant validity; furthermore, it showed antenatal–postnatal test–retest reliability, 97.5% diagnostic accuracy, 79.5% sensitivity, 94.9% specificity, 70.5% positive predictive power, and 92.8% negative predictive power. Conclusions. The ISQ is useful, valid, and reliable for assessing perinatal insomnia in Italian women. The Italian version showed equivalent properties to the original version.

314. Six-Month Post-Acute Sequelae of COVID-19: High Self-Reported Morbidity among Women and Younger Adults

Background Long term sequelae across multiple medical domains, including the respiratory, psychiatric, and neurocognitive have been reported after COVID-19. Studies evaluating the impact of this symptom burden, however, are lacking. We aimed to describe the self-reported occurrence of symptoms and their effect on patient functioning six months after their acute hospitalization for COVID-19. Methods From a historical cohort study of patients hospitalized for COVID-19 between March 8, and June 14, 2020, we identified patients discharged home. The purpose of the study was explained, and they were asked to consent to a telephone questionnaire. We used a modified version of a previously validated general symptom questionnaire (GSQ-30) to assess multi-system symptom burden. The Patient Health Questionnaire-2 (PHQ-2) was used to screen for major depression. Results Of the original 565 patients, 258 patients were discharged home (45%). Of these, 57 (22%) patients were able to be contacted and agreed to participate in the survey. The mean (SD) age of the respondents was 55.1 (14.8) years, and 37 (64.9%) were female. The most common symptoms at follow-up were fatigue (60.0%), dyspnea (57.1%), feeling irritable, sad or decreased pleasure (56.4%), and memory difficulty (56.4%). Females had a significantly higher GSQ score (0.02) than males. Patients ages < 60 years tended to experience similar, if not greater, impaired functioning (p=0.07) compared with those ages ≥ 60 years (Table 1). Females were more likely to be irritable or sad (p=0.007), not feel rested on awakening (p=0.04), have shooting, stabbing and burning pain (p=0.02), have discomfort with normal light and sound (p=0.04), and have memory difficulty (p=0.04) than males (Table 2). Table 1. Self-Reported Post-Acute Sequelae of COVID syndrome in adults younger than 60 versus adults at or older than 60 Years. SD: Standard deviation, ICU: Intensive care unit, ED: Emergency department, GSQ - General symptom questionnaire, PHQ-2: Patient Health Questionnaire-2 Table 2. Self-Reported Post-acute Sequelae of COVID syndrome in female versus male adults. SD: Standard deviation, ED: Emergency department, GSQ - General symptom questionnaire, PHQ-2: Patient Health Questionnaire-2 Conclusion Our study describes the clinical burden of post-acute sequelae of COVID-19 (PASC) in four core domains: fatigue, neurologic, neuro-psychiatric and viral-like symptoms. Over 45% of patients ages < 60 years suffered impaired functioning, compared with 21.1% of patient’s ages 60 years and above. Females had significantly higher GSQ scores than men which strongly corelates with the functional impairment among the females. Larger studies are needed to further validate our findings. Disclosures All Authors: No reported disclosures

Cross-cultural linguistic adaptation of Arabic version of four dimensional symptom questionnaire (4DSQ) for assessing distress, anxiety, depression and somatization in Egyptian primary care attendees

Background The four-dimensional symptom questionnaire (4DSQ) is a Dutch self-administered screening tool that has been developed in primary care to differentiate non pathologic general distress from depression, anxiety and somatization. It has been validated in the English language as well as other languages yet it has not been validated in Arabic. For the sake of developing the appropriate Arabic version, linguistic validation has been sought with the guidance of crosscultural adaptation guidelines. Objective To design the appropriate Arabic version of the 4DSQ that has linguistic and conceptual equivalence to its validated English version and that is appropriate for administration to Egyptian primary care attendees. Methods The validated English version of the 4DSQ was translated by 5 translators (including specialist psychiatrist, internists and English language specialist) into Arabic (Egyptian spoken dialect) without mutual consultation. An expert committee that consisted of 2 professors of public health and family medicine and an associate professor of neuropsychiatry was formed. The consensus version was created after expert committee modification and approval of each questionnaire item using DELPHI method. After that the back translation to English was carried out by two independent bilingual physicians whose English is their mother tongue. A pilot study was carried out on 17 bilingual participants after answering the questionnaire in both languages to test its equivalence. The consensus Arabic version was updated based on the pilot study and the final version was developed. The final version was then tested on 278 Egyptian primary care attendees. Results After the course of forward and back translation, expert committee’s review and developer’s comments, the final version of Arabic 4DSQ was developed for assessment of distress, depression, anxiety and somatization. There was no significant difference between results of Arabic and English questionnaire using paired T test. Final testing showed very good internal consistency of each of the 4 scales of the questionnaire. Conclusion The Arabic 4DSQ linguistically and conceptually corresponds to the validated English 4DSQ. It has good structural validity and internal consistency reliability and thus could be used in primary care after further psychometric validation.

Evaluation of the Efficacy of Postoperative Triamcinolone in Endoscopic Dacryocystorhinostomy using Lacrimal Symptom Questionnaire

Purpose: To evaluate the effect of postoperative nasal triamcinolone spray use in primary endoscopic dacryocystorhinostomy using The Lacrimal Symptom Questionnaire .Methods: This study included a series of 50 consecutive retrospective cases with primary endoscopic dacryocystorhinostomy and with silicone stent implantation who were followed up for 6 months postoperatively. Patients using nasal triamcinolone spray for 3 months postoperatively were included in the triamcinolone group. Patients not using triamcinolone were included in the control group. Lacrimal stents were removed 3 months postoperatively. The Lacrimal Symptom Questionnaire (Lac-Q) was performed in the preoperative and postoperative 6th month. Anatomical success, functional success, and changes in lacrimal symptom and social impact scores were compared between the two groups 6 months after surgery.Results: Results of 48 endoscopic dacryocystorhinostomies performed on 48 patients (23 triamcinolone group, 25 control group) meeting the inclusion criteria were analyzed. The anatomical success rate (95.7% vs. 84.0%, p = 0.350) and the functional success rate (91.3% vs. 76.0%, p = 0.249) were higher in the triamcinolone group, but this difference was not statistically significant. No complications were observed in the triamcinolone group, whereas complications developed in two patients in the control group (p = 0.490). The mean change in total lac-Q score was 11.0 in the triamcinolone group and 9.0 in the control group (p = 0.011). The mean change in social impact score was 4.0 in the triamcinolone group and 3.0 in the control group (p = 0.005). Mean change in lacrimal symptom score was 6.0 in the triamcinolone group and 6.0 in the control group (p =0.368)Conclusions: Our study indicated that postoperative use of triamcinolone spray increases the success rate of endoscopic dacryocystorhinostomy. also revealed that triamcinolone may also lead to greater improvement in quality of life scores than the control group using a validated questionnaire.

Rasch analysis for development and reduction of Symptom Questionnaire for Visual Dysfunctions (SQVD)

To develop the Symptom Questionnaire for Visual Dysfunctions (SQVD) and to perform a psychometric analysis using Rasch method to obtain an instrument which allows to detect the presence and frequency of visual symptoms related to any visual dysfunction. A pilot version of 33 items was carried out on a sample of 125 patients from an optometric clinic. Rasch model (using Andrich Rating Scale Model) was applied to investigate the category probability curves and Andrich thresholds, infit and outfit mean square, local dependency using Yen’s Q3 statistic, Differential item functioning (DIF) for gender and presbyopia, person and item reliability, unidimensionality, targeting and ordinal to interval conversion table. Category probability curves suggested to collapse a response category. Rasch analysis reduced the questionnaire from 33 to 14 items. The final SQVD showed that 14 items fit to the model without local dependency and no significant DIF for gender and presbyopia. Person reliability was satisfactory (0.81). The first contrast of the residual was 1.908 eigenvalue, showing unidimensionality and targeting was − 1.59 logits. In general, the SQVD is a well-structured tool which shows that data adequately fit the Rasch model, with adequate psychometric properties, making it a reliable and valid instrument to measure visual symptoms.

P–793 Validation of French in vitro fertilization (IVF) guideline during Covid–19 pandemic by the research of Sars-Cov–2 RNA in the follicular fluid (FF) after egg retrieval

Study question Is it possible to find viral Sars-Cov–2 RNA in FF of women undergoing treatment during Covid–19 pandemic that may compromise gamete and embryo safety? Summary answer No viral RNA was detected in tested FF of women undergoing IVF in compliance with recommendations. This was reassuring and supported good medical practice. What is known already Risks due to SARS-CoV–2 during IVF remain difficult to assess despite the screening recommended by French health authorities based on a symptom questionnaire of the couple (systematic testing by RT-PCR for the virus before egg retrieval (ER) is not mandatory). In this context, this is a real challenge for IVF laboratory to guarantee procedure, patients, gametes and embryos safety. Most studies have reported the absence of virus in sperm. No data are available for FF and only one study looked for the presence of the virus in oocytes of Covid-affected patients (Barragan M et al, 2020). Study design, size, duration Between June 17 and September 24, 2020, FF of consenting women were prospectively collected and symptom questionnaire recorded. During this period, women undergoing IVF in our center did not benefit from systematic PCR testing for the virus within 72 hours prior to ER through our health authorities’ recommendations. All collected FF were retrospectively tested to research viral RNA by RT-PCR and patients were recalled to answer an epidemiological follow-up questionnaire. Participants/materials, setting, methods For all couples, symptom questionnaires were prospectively recorded and verified at each step of IVF procedure. For all consenting women, a sample of 1 ml of FF was collected the day of ER and stored at –80 °C. After thawing, a Sars-Cov2 multiplex RT-PCR using CFX96 (Biorad*) was performed, after RNA extraction using Nimbus (Seegene*). A comprehensive epidemiological evaluation was made afterwards by phone interview and data were recorded and analyzed. Main results and the role of chance A total of 183 women was included out of the 214 treated during this period (85.5%). Retrospective epidemiological evaluation showed that 8 patients contracted Covid more than 2 months before the ER, 6 more than 2 months after and only one patient 1 month after ER (diagnosis based on pathognomonic signs as agueusia and anosmia or/and positive PCR ). We observed a prevalence of symptomatic Covid forms in our IVF population of 8.2% during a 6-month period surrounding their IVF cycle. Moreover, until the introduction of systematic testing by RT-PCR for the virus before ER since the end of September 2020, 3 patients have been cancelled out of the 403 planned for positive PCR despite a negative questionnaire, which represents a prevalence of asymptomatic forms on the day of the ER at 0.7%. All the 183 FF tested did not reveal any viral RNA detection, which was reassuring concerning our medical practice and patient compliance and transparency. The absence of detected viral RNA may be due to several reasons: 1) women were not infected the day of ER 2) women had an asymptomatic form of the disease with low viral load 3) FF is not a virus reservoir. Limitations, reasons for caution Not all patients were included (85.5%). Post-diagnosis stays uncertain because PCR tests at the beginning of the epidemic were not mandatory and hardly available. Wider implications of the findings: The absence of viral RNA in FF of women only screened through a symptom questionnaire is reassuring concerning the safety of IVF during Covid pandemic. Trial registration number Not applicable

Use of remote patient monitoring in the care of COVID-positive patients in oncology.

1554 Background: Cancer patients face an increased risk of developing acute complications from COVID-19. Remote monitoring can help with the critical need for early detection of symptoms among those diagnosed with COVID-19, enabling timely symptom management that can mitigate clinical deterioration. In response to this need, Memorial Sloan Kettering Cancer Center fast-tracked a program to monitor patients with COVID-19 from home, using an electronic symptom-tracking questionnaire and digital pulse oximeter to track patients’ status and alert care teams to intervene if symptoms worsened. A multi-disciplinary group composed of Oncology providers, advanced practice providers, nursing, nursing informatics and biomedical informatics formed to manage the program. Methods: Memorial Sloan Kettering launched a remote monitoring program for patients diagnosed with COVID-19 on March 25, 2020. All patients testing positive for COVID-19 were enrolled in the program and asked to complete a daily symptom tracking questionnaire accessed through their patient portal or administered verbally over the phone. A subset of high risk patients were also provided with a digital pulse oximeter linked to their patient portal and capable of transmitting readings directly to the care team. Clinicians received alerts for patients reporting symptoms or an oxygen saturation below 92%. Alerts resulted in an immediate response from the care team to determine if the patient needed additional care. We retrospectively evaluated the program usage, outcomes and learnings from March 25, 2020 to December 22, 2020. Results: In total, 1,721 patients were enrolled in the program from March 25, 2020 to December 22, 2020. Among these, 210 were deemed high risk patients who received a pulse oximeter in addition the daily symptom questionnaire. Over this period, 27% of patients triggered an alert from an electronic symptom questionnaire, and 63% of patients with a pulse oximeter triggered an alert from their device. Among patients who triggered an alert of any kind, 3% were triaged to a higher level of care. Patients reported that the program was highly valued and alleviated anxiety about their care. Iterative improvements were made to the program over time in response to the evolving knowledge about care for patients with COVID-19. Conclusions: Memorial Sloan Kettering was able to quickly implement a program to detect and triage symptoms among patients with COVID-19 and cancer. Refinements were made over time to many aspects of the program in response to learnings about care related to COVID-19, including to clinical eligibility, alert criteria, monitoring duration and workflows. The program also demonstrated value for patients who felt more comfortable with their care while being monitored remotely. This program established a successful model for remote monitoring of patients with COVID-19 with the potential to be scaled to other institutions or clinical areas.

Delivery of systemic anti-cancer therapy during the COVID-19 pandemic

Background The first confirmed case of COVID-19 in Ireland was on February 29th 2020. From March until late April, the number of cases increased exponentially. The delivery of anti-cancer therapy during the COVID-19 pandemic was extremely challenging. In order to balance the benefits of continuing anti-cancer therapy with the associated increased hospital visits, combined with the risk of COVID-19 infection, we undertook a series of system changes in the delivery of cancer care. Methods Patients who attended our dayward over a 4-month period were included. Data were obtained from patient and chemotherapy prescribing records. Patients were screened for symptoms of COVID-19 at two separate timepoints: prior to their visit via telephone, and using a symptom questionnaire on arrival at the hospital. If patients displayed COVID-19 symptoms, they were isolated and a viral swab arranged. Results A total of 456 patients attended from January 1st to April 30th. The numbers of visits from January to April were 601, 586, 575, and 607, respectively. During this period, there were 2369 patient visits to the dayward and 1953 (82%) intravenous regimens administered. Of the 416 visits that did not lead to treatment, 114 (27%) were scheduled non-treatment review visits, 194 (47%) treatments were held due to disease-related illness, and 108 (26%) treatments were held due to treatment-related complications. Screening measurements were implemented on March 18th due to rising COVID-19 prevalence in the general population. Overall, 53 treatments were held due to the screening process: 19 patients (36%) elicited COVID-19 symptoms via telephone screening; 34 patients (64%) were symptomatic in our pre-assessment area and referred for swabs, of which 4 were positive. Those with a negative swab were rescheduled for chemotherapy the following week. Conclusions With careful systematic changes, safe and continued delivery of systemic anti-cancer therapy during the COVID-19 pandemic is possible.

Desiccated Thyroid Extract Versus Synthetic LT4/T3 Combination Versus LT4 Monotherapy in the Treatment of Primary Hypothyroidism With Special Attention to the Thr92AlaD2 Polymorphism. With Special Attention to the Gene Polymorphism

Introduction: Before the availability of levothyroxine (LT4), patients were treated with desiccated thyroid extract (DTE). When switching from DTE to LT4, despite adequate dosing based on serum TSH levels, some patients still feel unwell with fatigue, mental fogginess, weight gain etc. A recent randomized, crossed over study between DTE vs. LT4 conducted in our department showed that once-daily DTE caused modest weight loss and possible improvement in mental health scores without appreciable adverse effects; also, nearly half of the study patients preferred DTE over LT4. A few studies have shown that LT4/T3 combination had beneficial effects in improving quality of life relative to LT4 alone. Furthermore, it has been reported that patients with CC genotype in the deiodinase type 2 polymorphism responded more favorably with LT4/T3 combination than T4 monotherapy. Hypothesis: This study investigated the efficacy and effectiveness of DTE vs. LT4/T3 combination vs. LT4 monotherapy in hypothyroid patients based on genotypic differences of deiodinase type 2. Methodology: This was a prospective, randomized, double-blind, crossover study. 75 subjects completed the study. There were 3 arms: DTE, LT4+T3 combination, and LT4 alone. Each subject was randomly allocated to one of these 3 arms for 12 weeks randomly. The study was powered to detect the primary outcome. The primary endpoint was post-treatment score on the 36-point thyroid symptom questionnaire. Secondary endpoints were weight, general health questionnaire, the Beck depression inventory, Wechsler Memory testing, lipid panels and thyroid function tests. Analysis was performed with a linear mixed model using subject as a random factor and group as a fixed effect. Results: There was no significant difference between the 3 arms on the thyroid symptom questionnaire (p=.32), and the secondary outcomes showed no between group differences. Auditory memory index (p=.008), and visual working memory index (p=.02) were higher in the Hashimoto’s than non-Hashimoto’s group. There was no significant primary or secondary outcome difference among various genotypes of deiodinase 2. There was no relationship between Hashimoto’s vs. non-Hashimoto’s based on genotypes or likelihood of carrying Thr92AlaD2 polymorphism. Though there was no statistically significant preference for any treatment, numerically more patients with Hashimoto’s preferred DTE and LT4/T3 combination than LT4-monotherapy. Conclusions: There was no significant difference between hypothyroid patients taking DTE vs. LT4/T3 combination vs. LT4 monotherapy. Numerically, Hashimoto’s patients tended to prefer DTE and LT4/T3 combination. Also, there was no observed relationship between Hashimoto’s and polymorphism. Further studies with more patients may be needed.