NEONATAL FOLLOW-UP IN CANADA. A NATIONAL SURVEY

Abstract BACKGROUND The Canadian Neonatal Follow-Up Network (CNFUN) was developed in 2008 to facilitate collaboration in research by providing a national database and implemented standardized neurodevelopmental assessments at 18 and 36 months corrected ages for babies born <29-week gestational age. Previous Canadian surveys showed a large variability in neonatal follow-up practices. This is the first Canadian national survey since the establishment of CNFUN. OBJECTIVES To describe the current status of neonatal follow-up services in Canada and to evaluate the impact of CNFUN by comparing the results of the current survey to a 2006 survey. Proportions are compared using chi square, p value < 0.006 adjusted for multiple comparisons. DESIGN/METHODS All 26 Level-III University Affiliated Neonatal Follow-up programs in Canada belonged to CNFUN and were invited to participate in this comprehensive online survey. Questions were based on previous survey results, current literature and discussion amongst the investigators. RESULTS 23/26 (88%) of invited programs completed the survey. Scope of service: All programs provided neurodevelopmental screening and referral for intervention. Data collection, training and education were provided by most programs (>80%). Therapeutic interventions were offered by a smaller number of programs (>50%). Type of Assessments: The use of Bayley Scales of Infant and Toddler Development increased significantly since 2006. For speech and language, adaptive behavior, and psychological standardized assessments tools a large variation remains. Follow-Up Schedule: Most programs offer between 5 to 7 follow-up visits. There remains a great variability in the timing of visits. Eligibility Criteria: The use of gestational age eligibility criteria, the inclusion of up to 29 weeks, and the expansion to include additional neurologic, cardio-respiratory, and fetal diagnosis has increased since 2006. CONCLUSION CNFUN was associated with a clinically important, statistically non-significant standardization. Non-preterm eligibility criteria have increased. Marked variability in Neonatal follow-up practices persist. Standardized follow-up has potential benefits of including facilitating multi-centered research, site benchmarking, and continuity of care for families who move.

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Neonatal follow-up programs in Canada: A national survey

Paediatrics & Child Health ◽

10.1093/pch/pxz159 ◽

2019 ◽

Author(s):

Fawaz Albaghli ◽

Paige Church ◽

Marilyn Ballantyne ◽

Alberta Girardi ◽

Anne Synnes

Keyword(s):

Online Survey ◽

Current Status ◽

Tertiary Level ◽

Large Variability ◽

Audit Data ◽

Marked Variability ◽

Survey Results ◽

Changes Over Time ◽

Bayley Scales

Abstract Background A 2006 Canadian survey showed a large variability in neonatal follow-up practices. In 2010, all 26 tertiary level Neonatal Follow-Up clinics joined the Canadian Neonatal Follow-Up Network (CNFUN) and agreed to implement a standardized assessment (including the Bayley Scales of Infant and Toddler Development-III (Bayley-III) at 18 months corrected age for children born < 29 weeks’ gestation. It is unknown whether the variability in follow-up practices lessened as a result. Objectives To describe the current status of neonatal follow-up services in Canada and changes over time. Methods A comprehensive online survey was sent to all tertiary level CNFUN Follow-up programs. Questions were based on previous survey results, current literature, and investigator expertise and consensus. Results Respondents included 23 of 26 (88%) CNFUN programs. All sites provide neurodevelopmental screening and referrals in a multidisciplinary setting with variations in staffing. CNFUN programs vary with most offering five to seven visits. Since 2006, assessments at 18 months CA increased from 84% to 91% of sites, Bayley-III use increased from 21% to 74% (P=0.001) and eligibility for follow-up was expanded for children with stroke, congenital diaphragmatic hernia and select anomalies detected in utero. Audit data is collected by > 80% of tertiary programs. Conclusion Care became more consistent after CNFUN; 18-month assessments and Bayley-III use increased significantly. However, marked variability in follow-up practices persists.

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The Effect of Javanese Language Videos with a Community Based Interactive Approach Method as an Educational Instrument for Knowledge, Perception, and Adherence amongst Tuberculosis Patients

Pharmacy ◽

10.3390/pharmacy9020086 ◽

2021 ◽

Vol 9 (2) ◽

pp. 86

Author(s):

Fauna Herawati ◽

Yuni Megawati ◽

Aslichah ◽

Retnosari Andrajati ◽

Rika Yulia

Keyword(s):

Intervention Group ◽

Personal Control ◽

Control Group ◽

P Value ◽

Interactive Approach ◽

Community Based ◽

Tuberculosis Patients ◽

Level Of Knowledge ◽

The Impact

The long period of tuberculosis treatment causes patients to have a high risk of forgetting or stopping the medication altogether, which increases the risk of oral anti-tuberculosis drug resistance. The patient’s knowledge and perception of the disease affect the patient’s adherence to treatment. This research objective was to determine the impact of educational videos in the local language on the level of knowledge, perception, and adherence of tuberculosis patients in the Regional General Hospital (RSUD) Bangil. This quasi-experimental study design with a one-month follow-up allocated 62 respondents in the intervention group and 60 in the control group. The pre- and post-experiment levels of knowledge and perception were measured with a validated set of questions. Adherence was measured by pill counts. The results showed that the intervention increases the level of knowledge of the intervention group higher than that of the control group (p-value < 0.05) and remained high after one month of follow-up. The perceptions domains that changed after education using Javanese (Ngoko) language videos with the Community Based Interactive Approach (CBIA) method were the timeline, personal control, illness coherence, and emotional representations (p-value < 0.05). More than 95% of respondents in the intervention group take 95% of their pill compared to 58% of respondents in the control group (p-value < 0.05). Utilization of the local languages for design a community-based interactive approach to educate and communicate is important and effective.

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Ovarian Dysgerminoma in Pregnant Women with Viable Fetus: A Rare Case Report

Case Reports in Oncology ◽

10.1159/000513622 ◽

2021 ◽

pp. 141-146

Author(s):

Reda Youssef ◽

Gamal Sayed Ahmed ◽

Samir Alhyassat ◽

Sanaa Badr ◽

Ahmed Sabry ◽

...

Keyword(s):

Gestational Age ◽

Ovarian Neoplasms ◽

Imaging Modality ◽

Reproductive Age ◽

Diagnostic Challenge ◽

Short Period ◽

Ovarian Dysgerminoma ◽

The Impact ◽

In Pregnancy

Dysgerminoma is an uncommon malignant tumor arising from the germ cells of the ovary. Its association with pregnancy is extremely rare, with a reported incidence of about 0.2–1 per 100,000 pregnancies. Women in the reproductive age group are more commonly affected. It can be extremely rare to conceive naturally, without assisted reproductive interventions, in cases with ovarian dysgerminoma. If a pregnancy does occur with a concurrent dysgerminoma, it is even more unusual to carry the pregnancy to viability or childbirth without fetal or maternal compromise. We report a case of right ovarian dysgerminoma in a young female with a viable intrauterine pregnancy at 10 weeks, which is rarely diagnosed and managed at this gestational age. Numerous factors played a role in her favorable outcome, including early suspicion by ultrasound and presenting history, surgery, histopathological assessment, imaging, and involvement of the multidisciplinary oncology team. Ovarian neoplasms may rapidly increase in size within a short period with little or no symptoms. This poses a diagnostic challenge for obstetricians and oncologists. Hence, we aimed to evaluate the role of imaging in pregnancy using ultrasound as an imaging modality for both early detection of ovarian neoplasms and for follow-up. In conclusion, patients with ovarian dysgerminoma in pregnancy can have favorable outcomes. Treatment should be individualized on a case-to-case basis, depending on many factors; cancer stage, previous reproductive history, the impact of imaging in staging or follow-up of tumor on the fetus, fetal gestational age, and whether termination of the pregnancy can improve survival or morbidity for the mother.

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T3 Are Burns a Chronic Condition: Examining Physical and Mental Functioning up to 20 Years After Injury

Journal of Burn Care & Research ◽

10.1093/jbcr/irab032.002 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

pp. S2-S3

Author(s):

Callie Abouzeid ◽

Audrey E Wolfe ◽

Gretchen J Carrougher ◽

Nicole S Gibran ◽

Radha K Holavanahalli ◽

...

Keyword(s):

Mental Health ◽

Hospital Stay ◽

National Database ◽

Time Points ◽

Patient Reported ◽

Burn Survivors ◽

Population Demographic ◽

The Impact ◽

Over Time

Abstract Introduction Burn survivors often face many long-term physical and psychological symptoms associated with their injury. To date, however, few studies have examined the impact of burn injuries on quality of life beyond 2 years post-injury. The purpose of this study is to examine the physical and mental well-being of burn survivors up to 20 years after injury. Methods Data from the Burn Model System National Database (1997–2020) were analyzed. Patient-reported outcome measures were collected at discharge with a recall of preinjury status, and then at 5, 10, 15, and 20 years after injury. Outcomes examined were the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Short Form-12. Trajectories were developed using linear mixed methods model with repeated measures of PCS and MCS scores over time and controlling for demographic and clinical variables. The model fitted score trajectory was generated with 95% confidence intervals to demonstrate score changes over time and associations with covariates. Results The study population included 420 adult burn survivors with a mean age of 42.4 years. The population was mainly male (66%) and white (76.4%) with a mean burn size of 21.5% and length of hospital stay of 31.3 days. Higher PCS scores were associated with follow-up time points closer to injury, shorter hospital stay, and younger age. Similarly, higher MCS scores were associated with earlier follow-up time points, shorter hospital stay, female gender, and non-perineal burns. MCS trajectories are demonstrated in the Figure. Conclusions Burn survivors’ physical and mental health worsened over time. Such a trend is different from previous reported results for mental health in the general population. Demographic and clinical predictors of recovery over time are identified.

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The Impact of Legalization of Access to Recreational Cannabis on Canadian Medical Users with Cancer.

10.21203/rs.3.rs-15703/v4 ◽

2020 ◽

Author(s):

Philippa Helen Hawley ◽

Monica Gobbo ◽

Narsis Afghari

Keyword(s):

Cancer Patients ◽

Cannabis Use ◽

P Value ◽

Medical Cannabis ◽

Eligibility Criteria ◽

Cross Sectional ◽

Access System ◽

Patterns Of Use ◽

Barriers To Access ◽

The Impact

Abstract Background Canada legalized cannabis use for medical purposes in 1999. Legalization of cannabis for recreational purposes in October 2018 offered the opportunity to assess the impact of recreational legalization on cancer patients’ patterns of use to identify learning points that could be helpful to other countries considering similar legislation.Method Two identical anonymous cross-sectional surveys were administered to cancer patients in British Columbia (2 months before and 3 months following legalization), with the same eligibility criteria. The prevalence of medical cannabis use, the distribution of symptoms leading to use, the most common types of cannabis products and sources, reasons for stopping using cannabis, and barriers to access were assessed.Results The overall response rate was 27%. Both cohorts were similar regarding age (median= 66yrs), gender (53% female), and education (approximately 85% of participants had an education level of high school graduation and higher). Respondents had multiple motives for taking cannabis, including to manage multiple symptoms, to treat cancer, and for recreational reasons. The majority of patients in both surveys did not use the legal medical access system. Comparison of the two cohorts showed that after legalization the prevalence of current cannabis use increased by 26% (23·1% to 29·1%, p-value 0·01), including an increased disclosure of recreational motive for use, from 32% to 40%. However, in the post-legalization cohort more Current Users reported problems getting cannabis (18%) than the pre-legalization cohort (8%), (p-value <0·01). The most common barrier cited was lack of available preferred products, including edibles, as these were only available from illegal dispensaries. Conclusions Results showed that legalization of cannabis for recreational purposes may have an impact on those who use medical cannabis. Impacts include an increase in prevalence of use; problems accessing preferred products legally; higher cost, and difficulties using a legal access system. The desired goal of regulation in reducing harms from use of illegal cannabis products are unlikely to be achieved if the legal process is less attractive to patients than use of illegal sources.

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P–759 The impact of the COVID–19 pandemic on women seeking fertility treatment in Germany: the patient´s perspective

Human Reproduction ◽

10.1093/humrep/deab130.758 ◽

2021 ◽

Vol 36 (Supplement_1) ◽

Author(s):

S Wedner-Ross ◽

F Vo. Versen-Höynck

Keyword(s):

Study Design ◽

Online Survey ◽

Fertility Treatment ◽

Unborn Child ◽

Negative Effects ◽

Cross Sectional ◽

Professional Societies ◽

Fertility Treatments ◽

The Impact

Abstract Study question This cross-sectional survey sought the views of women seeking fertility treatment on the impact of the COVID–19 pandemic on their fertility treatment and attitudes. Summary answer Most respondents worried the recommendations to postpone treatment would reduce their chances of pregnancy and were concerned about negative effects of SARS-Cov–2 infections on pregnancy. What is known already In spring 2020, the recommendations of ESHRE and German professional societies to postpone fertility treatments resulted in limited or closed services from mid-March to early May in many clinics. Previous studies reported that postponing fertility clinic appointments causes psychological distress, with most patients saying they would have preferred to continue treatment. While no similar studies are available from Germany, where COVID–19 incidence was relatively low, concerns of the patients about possible consequences of a treatment delay and a SARS-CoV–2 infection on fertility and pregnancy remain unknown. Study design, size, duration This cross-sectional, anonymous, online questionnaire was completed in June-December 2020 by 249 women attending fertility clinics across Germany. The women were recruited using leaflets, directly by study personnel either in person or by telephone, or via online support group forums for fertility patients. Participants/materials, setting, methods All women seeking treatment in fertility clinics were eligible to participate. The online survey covered questions about the patient’s quality of life, their opinions about the professional societies’ recommendations and their effects as well as any concerns about infection with SARS-CoV–2. Statistical analysis was conducted using SPSS Version 27. Main results and the role of chance Three-quarters of participants disagreed with the pausing of fertility treatments. Women who participated from October-December 2020, when the incidence rate was high, were as likely to disagree as participants that participated from June-September 2020 (73% vs 79%, p = 0.3). Nearly all participants (95%) were concerned that treatment delays would reduce their chances of pregnancy. 72 participants (29%) had their appointments cancelled. Nearly all (97%) reported being upset by this, with 40 (56%) reporting that they were extremely or very disappointed about the cancellation. Women coming for follow-up appointments and women who had to wait 10 weeks or longer were more likely to be upset by the postponement or cancellation of their appointment (p = 0.016 and p = 0.012, respectively). Nearly all (97%) of the participants were worried about possible negative effects a SARS-CoV–2 infection might have related to their fertility, pregnancy or unborn child. Sixty-one percent stated they were very or moderately concerned about the negative influence the infection might have on the womańs own health during pregnancy and 60% were very to moderately concerned about potential negative effects for the unborn child. However, only 26% reported they were very or moderately concerned about the potential negative effects of an infection on fertility. Limitations, reasons for caution The main limitations of this study are the possibility of selection bias as people with strong opinions are more likely to have participated and the lack of information on non-responders due to the study design. Also, the Covid–19 pandemic is evolving continuously meaning that participantś opinions may vary over time. Wider implications of the findings: Postponement of treatments increased distress among patients and should be avoided when possible. If unavoidable, follow-up patients should be prioritised for treatment and the length of postponement should be minimised. Fertility clinics must provide information about the current state of knowledge of SARS-Cov–2 infections in pregnancies and options for immunization. Trial registration number Not applicable

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The Functional Endoscopic Approach to Inflammatory Sinus Disease: Current Perspectives and Technique Modifications

American Journal of Rhinology ◽

10.2500/105065888781693078 ◽

1988 ◽

Vol 2 (3) ◽

pp. 89-96 ◽

Cited By ~ 91

Author(s):

David W. Kennedy ◽

S. James Zinreich

Keyword(s):

Computed Tomography ◽

Surgical Techniques ◽

The United States ◽

Endoscopic Examination ◽

Lessons Learned ◽

Current Status ◽

Sinus Disease ◽

Technical Modifications ◽

The Impact

Endoscopic examination and pleuridirectional polytomography provided some important insights into the pathogenesis of inflammatory sinus disease. These insights have been further refined by the increasing utilization of endoscopy in medical therapy and surgical follow-up, and by the use of computed tomography for diagnosis. The aim of this paper is to review the current status of the diagnosis of chronic inflammatory sinus disease and of functional endoscopic surgical techniques. The impact of this approach on previously held theoretical and diagnostic concepts is evaluated. Technical modifications made since the surgery was first introduced in the United States and the lessons learned from close postsurgical endoscopic examination are presented.

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Risk Factors for Iron Deficiency in Very Preterm Infants at 4-6 Months Corrected Age

Blood ◽

10.1182/blood-2020-142442 ◽

2020 ◽

Vol 136 (Supplement 1) ◽

pp. 28-28

Author(s):

Carmen Landry ◽

Jon Dorling ◽

Ketan Kulkarni ◽

Marsha Campbell-Yeo ◽

Michael Vincer ◽

...

Keyword(s):

Risk Factors ◽

Iron Deficiency ◽

Preterm Infants ◽

Serum Ferritin ◽

Gestational Age ◽

Iron Supplementation ◽

Gestational Hypertension ◽

Univariate Analysis ◽

P Value

Background: Iron is an essential micronutrient, especially in infants and young children and is required for erythropoiesis and development of the central nervous system. However, iron deficiency (ID) is the most common micronutrient deficiency worldwide. ID and iron deficiency anemia (IDA) have been associated with poor neurodevelopmental and behavioural outcomes later in life. Preterm infants are particularly at risk of developing ID in early life due to lower iron stores at birth, accelerated growth in the first weeks of life and multiple phlebotomies while in hospital. Therefore, international recommendations suggest prophylactic iron therapy of 2-4 mg/kg/day starting at 2-6 weeks of age until at least 6-12 months in preterm and low birth weight infants. This prophylactic iron supplementation has been shown to be effective at reducing the incidence of ID and IDA. However, the published work mainly involves moderate to late preterm infants and the research is lacking on iron status after discharge in very preterm infants (VPI, <31 weeks gestational age). Based on our previous work, 32% of the VPIs were iron deficient at 4-6 months corrected age despite this early supplementation. Since the development of ID may have permanent detrimental effects on the developing brain of these high-risk preterm infants, a knowledge of risk factors for ID is also important to identify strategies focused on its prevention. Objective: To investigate the risk factors associated with development of ID Methods: A retrospective cohort study was conducted at the IWK Health Centre using a population based provincial Perinatal Follow-Up Program database. All live-born VPIs born in Nova Scotia between 2005-2018 were included. Patients with congenital malformations, chromosomal anomalies, or who died prior to outcome assessment were excluded. As a standard of care, all these infants were started on prophylactic iron supplements (2-3 mg/kg/day) at 2-4 weeks of chronological age. Iron dosage was regularly adjusted during the hospital stay as guided by serum ferritin levels. At discharge, it was recommended to continue iron prophylaxis until 9-12 months corrected age. All these infants underwent a blood test during their first neonatal follow-up visit at 4-6 months corrected age to check for hemoglobin, reticulocyte count and serum ferritin. ID was defined as serum ferritin <20g/l or <12g/l at 4 and 6 months respectively. A univariate analysis was performed by using a series of single variable logistic regression models to identify the factors associated with presence of ID. Factors with a p-value < 0.20 in the univariate analysis were entered into a multivariable risk model for occurrence of ID using a backwards selection procedure. Variables with a p-value < 0.05 were retained. Results: Of 411 infants included in the study, 32.1% (n=132) had ID. The prevalence of ID decreased over time (37.6% in 2005-2011 vs 25.8% in 2012-2018 cohort). Table 1 compares the antenatal and neonatal characteristics of the ID and non-ID groups. Table 2 compares sociodemographic variables and clinical variables at the time of follow up of the two groups. Independent risk factors for ID were: gestational age (<27 weeks to >27 weeks) (OR:1.7 (1.0-2.9), p=0.04) and gestational hypertension (OR: 2.1(1.2-3.7), p=0.009). Independent factors protective for ID were: mixed feeding (breast milk and formula compared to formula alone) (OR: 0.5 (0.2-0.9), p=0.021) and iron supplementation at follow-up (OR:0.5 (0.3-0.9), p=0.02). Conclusion(s): Despite prophylactic iron supplementation, one-third of VPIs had ID at 4-6 months corrected age. Gestational hypertension in mother and gestational age < 27 weeks were independent risk factors for ID. In addition, despite adjusting for iron supplementation at follow-up, the formula feeding group was more likely to have ID compared to the mixed feeding group. This may be because of the sub-therapeutic iron intake in the formula fed infants. It is often thought that formula milk may have sufficient iron to meet the demands of growing infants and thus, they are less likely to receive higher doses of supplemental iron beyond what is contained in the formula. However, this may not be true since the iron present in formula may not have the same bioavailability as breast milk. Future prospective studies are required to further validate these observations. Nonetheless, the study identified important areas to mitigate ID in VPIs. Disclosures No relevant conflicts of interest to declare.

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Multidimensional Quantification of Exclusion Criteria to Reduce the Gap between Randomized Clinical Trial and Real-World Outcomes in Multiple Myeloma

Blood ◽

10.1182/blood-2021-148222 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 4003-4003

Author(s):

Augusta Eduafo ◽

Leland Metheny ◽

Ravi Kyasaram ◽

Farhad Sanati ◽

James J. Driscoll ◽

...

Keyword(s):

Real World ◽

Research Funding ◽

Advisory Board ◽

P Value ◽

Single Institution ◽

Exclusion Criteria ◽

Eligibility Criteria ◽

Real World Evidence ◽

Index Treatment

Abstract Randomized clinical trials (RCTs) are considered the highest level of evidence to define the efficacy of newly developed treatments before their adoption into clinical practice. RCTs incorporate exclusion criteria that eliminate specific patient populations in order to reduce the incidence of serious adverse events and enhance the efficacy of a given anti-cancer strategy. However, exclusion criteria may lead to a significant gap between patients (pts) enrolled on RCTs and real world pt populations, which represent the ultimate stakeholders in cancer treatment. The analysis of real-world evidence to answer clinical questions has recently gained increased interest. Assessing different dimensions of this gap may help overcome barriers in trial recruitment and enhance the applicability of RCTs in daily practice. There has been significant advancement in treating multiple myeloma (MM) over the past two decades bringing multiple new mechanisms of action to the bedside. We selected ten recent RCTs: ASPIRE, TOURMALNE-MM01, ELOQUENT-2, ENDEAVOR, POLLUX and CASTOR, OCEAN, ICARIA, APOLLO and ELOQUENT-3 studies, which are pharma-sponsored landmark trials that provided the basis for FDA approval of anti-myeloma agents. Our objective was to quantify the gap in eligibility criteria between the ten RCTs and real world populations by examining these trials using a single institution database. Methods: Pts with relapsed MM that were initiated on a second (or later line) of therapy that were recognized, retrospectively. Eligibility criteria of the ten landmark RCTs was applied during the 21 day period before the index treatment date. Pts that received Len-containing regimens were tested as to be enrolled on trials with Len/Dex control arm, patients that received Bor-containing regimens were examined to be enrolled on Bor/Dex trials and subjects who had Pom-containing regimen were screened for Pom/Dex trials. Pts were then classified as "Trial eligible" or "Trial ineligible", accordingly and were monitored longitudinally from the index treatment date until death, loss to follow-up, or end of the follow up period. Ten commonly used eligibility criteria were examined (Fig. 1). Any cancer in the three years prior to the index treatment date was counted as "history of other malignancies", i.e., skin and prostate cancer were excluded. Concurrent infection was defined as use of any antibiotic other than acyclovir, ciprofloxacin or bactrim. To calculate area under the curve of the polygon graphs Shoelace algorithm was used. Results : 516 pts were studied between 2010 and 2020 and 153 were excluded due to missing values. 224, 136 and 98 pts were treated with Len-, Bor- or Pom-containing regimens, respectively. Overall, the trial-eligible cohort was more likely to have autologous stem cell transplant and to have had longer treatment-free period before index treatment date (p-value: 0.009). There was a substantial variation in the ineligibility rate for these ten RCTs among the study population (Fig. 1). The most common items that excluded a patient from a RCT were: other malignancy, current infection and renal dysfunction. Differences between trial-eligible and trial-ineligible pts stratified by trial are listed in Tables 1, 2 and 3 for trials with Len, Bor and Pom as control arms, respectively. The median follow-up for the Len, Bor and Pom cohorts was 31, 30 and 22 months, respectively. Trial-ineligible pts displayed a significantly worse OS (2-year rate 58% vs. 78%, p-value: 0.001) and 49% higher chance of death (HR 1.69, 90%, CI: 1.17-2.62) compared with trial-eligible cohort. Conclusion: Here, we assessed the multidimensional gap that exists between patient cohorts enrolled on RCTs and real world cohorts for ten landmark MM trials. We present a quantitative deviation score as a tool to calibrate the generalizability of these landmark trials against a single institution. Importantly, we show that trial-eligibility alone significantly correlates with superior OS across a variety of MM clinical trials across all ten MM RCTs. Furthermore, our results reveal that ineligibility rates were quite different among the ten trials which significantly limit cross-trial comparisons. We propose a uniform methodology to assess patient exclusion criteria and narrow the efficacy gap observed between RCTs and real world evidence. Figure 1 Figure 1. Disclosures Metheny: Pharmacosmos: Honoraria; Incyte: Speakers Bureau. Malek: Medpacto Inc.: Research Funding; Amgen: Honoraria; Janssen: Other: Advisory board ; Takeda: Honoraria; BMS: Honoraria, Research Funding; Cumberland Inc.: Research Funding; Bluespark Inc.: Research Funding; Sanofi: Other: Advisory Board.

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The Impact of Resilience and Extraversion on Psychological Distress, Loneliness, and Boredom During the COVID-19 Pandemic: A Follow-Up Study Among the General Population of Tyrol, Austria

Frontiers in Psychiatry ◽

10.3389/fpsyt.2021.777527 ◽

2021 ◽

Vol 12 ◽

Author(s):

Franziska Tutzer ◽

Beatrice Frajo-Apor ◽

Silvia Pardeller ◽

Barbara Plattner ◽

Anna Chernova ◽

...

Keyword(s):

Psychological Distress ◽

General Population ◽

Online Survey ◽

Short Form ◽

Negative Association ◽

Mitigation Strategies ◽

Protective Effects ◽

Resilience Scale ◽

The Impact

Background: The Covid-19 pandemic and related measures represent an enormous burden on mental health. The aim of this study was to investigate longitudinal changes in psychological distress, loneliness, boredom, and resilience over the course of the pandemic and to examine the associations between resilience and extraversion at baseline (summer 2020) and psychological distress, loneliness, and boredom at 5-month-follow-up.Methods: Residents of Tyrol (≥18a) completed an online survey on psychological distress, loneliness, boredom, resilience, and extraversion by using the Brief-Symptom-Checklist, the Three-Item Loneliness Scale, the Multidimensional State Boredom Scale-Short Form (MSBS-SF), the Resilience Scale, and the Extraversion subscale of the Big Five Inventory.Results: Of the 961 baseline participants, 384 took part in the follow-up survey. The percentage of study participants with striking psychological distress remained the same. Similarly, resilience did not change from baseline to follow-up, whereas the number of those experiencing moderate loneliness increased significantly. In contrast, at follow-up, severe loneliness was detected in significantly less people. Boredom decreased significantly over time. A moderate negative association was detected between baseline resilience and psychological distress, loneliness, and boredom at follow-up, and a weak but still significant negative association between extraversion and these outcomes.Discussion: These findings indicate that a subset of the general population consistently suffers from high levels of psychological distress and point to the protective effects of resilience and extraversion in this context. They reemphasize the importance of prevention and mitigation strategies to address these public health problems.

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