Expert Panel Review Research Articles

2022 American College of Rheumatology/EULAR Classification Criteria for Takayasu Arteritis.

To develop and validate new classification criteria for Takayasu arteritis (TAK). Patients with vasculitis or comparator diseases were recruited into an international cohort. The study proceeded in 6 phases: 1) identification of candidate criteria items, 2) collection of candidate items present at diagnosis, 3) expert panel review of cases, 4) data-driven reduction of candidate items, 5) derivation of a points-based classification score in a development data set, and 6) validation in an independent data set. The development data set consisted of 316 cases of TAK and 323 comparators. The validation data set consisted of an additional 146 cases of TAK and 127 comparators. Age ≤60 years at diagnosis and imaging evidence of large-vessel vasculitis were absolute requirements to classify a patient as having TAK. The final criteria items and weights were as follows: female sex (+1), angina (+2), limb claudication (+2), arterial bruit (+2), reduced upper extremity pulse (+2), reduced pulse or tenderness of a carotid artery (+2), blood pressure difference between arms of ≥20 mm Hg (+1), number of affected arterial territories (+1 to +3), paired artery involvement (+1), and abdominal aorta plus renal or mesenteric involvement (+3). A patient could be classified as having TAK with a cumulative score of ≥5 points. When these criteria were tested in the validation data set, the model area under the curve was 0.97 (95% confidence interval [95% CI] 0.94-0.99) with a sensitivity of 93.8% (95% CI 88.6-97.1%) and specificity of 99.2% (95% CI 96.7-100.0%). The 2022 American College of Rheumatology/EULAR classification criteria for TAK are now validated for use in research.

Adaptation and Validation of the Nigerian (Igbo) Version of the WHOQOL-OLD Module

Objective: To adapt and validate the original English version of the World Health Organization Quality of Life Questionnaire-version for older adults (WHOQOL-OLD) in Igbo language, culture, and environment. Participants: Community-dwelling older adults (≥65 years) from Nnewi community in Nigeria. Methods: This was a cross-cultural adaptation and validation study. The original English version of the WHOQOL-OLD was translated into Igbo language, synthesized, backward translated into the English language, subjected to expert panel review, and pretested. The Igbo and English versions of the WHOQOL-OLD were then used to assess the quality of life among consecutively recruited 109 older adults through interviewer-administration. Findings: The structure of the Igbo version of the WHOQOL-OLD differed from that of the original WHOQOL-OLD. The Igbo version of the WHOQOL-OLD displayed acceptable internal consistency (0.63–0.95), known-group validity (0.60–0.99), convergent validity, and ceiling and floor effects. Conclusion: The I-WHOQOL-OLD is a reliable and valid tool and thus can be used as an outcome measure among Igbo-speaking older adults.

Arabic version of the Palliative Care Self-Efficacy Scale: Translation, adaptation, and validation.

A lack of confidence among oncology nurses might be problematic when providing palliative care. No valid and reliable tool is currently available in Saudi Arabia to assess oncology nurses' confidence in providing palliative care. This study aims to explain the process of translation, adaptation, and validation of the Palliative Care Self-Efficacy Scale (PCSS) to support its use in the Saudi context. This was a methodological study of translation, cultural adaptation, and content validation of PCSS. The process of translation and adaptation was conducted according to the World Health Organization guidelines, including forward and backward translations, an expert panel review, and pretesting and cognitive interviewing, resulting in a final version. Two independent bilingual oncology nurses familiar with palliative care terminology translated the PCSS from English to Modern Standard Arabic. Next, the concise PCSS translation developed from the 2 translations was back-translated to English by 2 English-speaking translators and then compared to the original PCSS. The Arabic version PCSS was evaluated by Saudi professionals (N=5) in oncology and palliative care nursing using a Likert scale for essentiality, relevance, clarity, and appropriateness. The content validity was examined using the calculation of the content validity ratio, item-level content validity index (I-CVI), and modified kappa statistics. The thinking aloud method was also used to interview Saudi oncology nurses (N=8) who had palliative care experience. The relevance, clarity, and appropriateness of the first Arabic version PCSS were validated. It had a level of content validity index of 1.00 for all items after improvements were made based on the recommendations of experts and oncology nurses. The PCSS demonstrated face and content validity in the assessment of oncology nurses' confidence in providing palliative care. The PCSS is suitable for use in palliative cancer care units in Saudi Arabia to identify the educational needs of nurses to promote their confidence and improve the quality of care. Additional reliable and valid language versions of the PCSS allow for international and national comparisons, which may be useful for oncology nursing administrators or managers who are accountable for the quality of palliative care during the strategic health-care planning process in cancer services.

Eco-designed retail packaging: The empirical conceptualization and measurement

Eco-designed retail packaging (ECRP) is essential for retailers to respond to increasing environmentally conscious consumerism. However, the conceptualization of ECRP and its measurement scale has not yet been developed. The primary objective of this study is to explore and validate attributes measuring ECRP through a three-stage mixed-method research design. Stage 1 identified dimensions and initial items of ECRP through extant literature review, content analysis of retail packaging designs, expert panel review and pretest. Stage 2 conducted a survey study (n = 200), and an exploratory factor analysis was performed to evaluate the reliability and validity of preliminary items. Stage 3 was carried out through a survey with sample of 410 supermarket shoppers in Vietnam. Confirmatory factor analysis and metric invariance tests were conducted to validate the final 28-item, six-dimension (functional attributes, aesthetic attributes, eco-material attributes, eco-information attributes, eco-production attributes and innovation attributes) scale for measuring ECRP.

The resilient potential behaviours in an Internal Medicine Department: Application of resilience assessment grid.

The healthcare system is frequently subject to unpredictable conditions such as organisational changes and pandemics. In order to perform as required under these conditions (i.e. exhibiting resilient behaviour), it is necessary to know the current position of the organisation with respect to the four resilient potentials i.e. respond, monitor, learn and anticipate. The study aimed to understand and assess resilient performance of an Internal Medicine Department in a public hospital in Denmark using the resilience assessment grid (RAG). A modified Delphi method was used to develop the context specific RAG, using interviews to generate items, two rounds of expert panel reviews and pilot testing the developed RAG questionnaire. The four sets of structured RAG questions were tested and revised until satisfactory face and content validity for application was achieved. The final version of the RAG (28-item Likert scale) questionnaire was sent electronically to 87 healthcare professionals (clinicians and managers) in January 2021 and 2022. The data was statistically analysed and illustrated in radar charts to assist in interpreting the resilience profiles. While the resilience profiles in 2021 and 2022 were similar, the scores in 2022 were slightly lower for some of the sub-indicators. The results indicate areas for improvement, especially related to the Internal Medicine Department's potential to respond and learn. The results from the RAG were presented to the chief clinical consultants and managers to identify initiatives for quality improvement and for planning a new workflow at the Internal Medicine Department. The RAG is a managerial tool to assess the potential resilient performance of the organisation in respect to the four resilience potentials, i.e., responding, monitoring, learning, and anticipating. It can be used to construct the resilience profile of the system over time to manage organisational changes.

A closer examination of the STEM characteristics of the STEM activities published in NSTA journals

ABSTRACT Background Based on the literature review, shared characteristics of integrated STEM (I-STEM) curriculum includes an engaging and motivating context, student participation in engineering design activities, opportunity to redesign, engaging in mathematics or science content, having student-centred pedagogies, and teamwork and communication. These principles and more were used to analyse STEM activities published in NSTA journals. Purpose It was to determine the extent to which the STEM activities published in three NSTA journals (Science and Children, Science Scope, and The Science Teacher) between the years 2013 and 2020 reflected the shared characteristics of I-STEM education. Sample A total of 161 STEM teaching activities were analysed during the study. Methods A STEM rubric (abbreviated as RACSTEM) developed by the authors. Expert panel reviews and intercoder agreement calculations provided support for the content validity and reliability of RACSTEM. The rubric was composed of seven main categories, namely, integrating different disciplines, real-world problem, learner-centeredness, teamwork, communication, redesign, and assessment. STEM activities were analysed based on RACSTEM through content analysis and reported using descriptive statistics. Results Different combinations of STEM and non-STEM disciplines were integrated into the activities. 76% of the activities included real-world problems. Learner centred strategies (e.g. project-based learning) were utilized in 81% of the STEM papers. In 94% of the papers, students mostly participated in group work. Analysis revealed that 58% of the papers asked learners what they would change at the redesign stage. Finally, in the assessment aspect, the most problematic one, results showed discrepancies between the integrative nature of STEM and its assessment. Conclusion It was unclear how many I-STEM activities were published in NSTA publications that fit the requirements for I-STEM once the NGSS was launched. The findings of this study, as well as the development of the RACSTEM instrument, seem to have the ability to resolve ambiguity.

IND01-03 Expert panel review of the neurotoxicology of Glyphosate in mammalian systems for risk assessment purposes

IND01-03 Expert panel review of the neurotoxicology of Glyphosate in mammalian systems for risk assessment purposes

Developing a self-administered questionnaire: methods and considerations.

Using a structured process to develop a self-administered questionnaire provides a robust tool for collecting data that enhances the credibility of the results. Describing this process mitigates any complexity and confusion for the nurse researcher which can be generated by many sources of information that either lack detail or have complex statistical approaches. To discuss the development of a self-administered questionnaire with a focus on face, content, construct validity and reliability testing. Adopting a well-established, sequential, five-step approach ensures that important concepts of questionnaire development are addressed: assessing existing tools and qualitative data, if available; drafting of the questionnaire with consideration for question styles, comprehension, acquiescent bias and face validity; expert panel review to establish content validity and inter-rater reliability; pilot testing to assess construct validity; and exploratory factor analysis to establish reliability testing. This approach results in a robust and credible tool for collecting data. This article provides nurse researchers with a structured process for developing self-administered questionnaires. Investing time and effort to assess a newly developed questionnaire for validity and reliability and consider question styles, comprehension and acquiescent bias results in an improved and strengthened tool for collecting data. This in turn enhances the quality and credibility of a study's findings.

206. Expert panel review for symptomatic Grade I degenerative spondylolisthesis

206. Expert panel review for symptomatic Grade I degenerative spondylolisthesis

Insights on the differentiation of stillbirths and early neonatal deaths: A study from the Child Health and Mortality Prevention Surveillance (CHAMPS) network

IntroductionThe high burden of stillbirths and neonatal deaths is driving global initiatives to improve birth outcomes. Discerning stillbirths from neonatal deaths can be difficult in some settings, yet this distinction is critical for understanding causes of perinatal deaths and improving resuscitation practices for live born babies.MethodsWe evaluated data from the Child Health and Mortality Prevention Surveillance (CHAMPS) network to compare the accuracy of determining stillbirths versus neonatal deaths from different data sources and to evaluate evidence of resuscitation at delivery in accordance with World Health Organization (WHO) guidelines. CHAMPS works to identify causes of stillbirth and death in children <5 years of age in Bangladesh and 6 countries in sub-Saharan Africa. Using CHAMPS data, we compared the final classification of a case as a stillbirth or neonatal death as certified by the CHAMPS Determining Cause of Death (DeCoDe) panel to both the initial report of the case by the family member or healthcare worker at CHAMPS enrollment and the birth outcome as stillbirth or livebirth documented in the maternal health record.ResultsOf 1967 deaths ultimately classified as stillbirth, only 28 (1.4%) were initially reported as livebirths. Of 845 cases classified as very early neonatal death, 33 (4%) were initially reported as stillbirth. Of 367 cases with post-mortem examination showing delivery weight >1000g and no maceration, the maternal clinical record documented that resuscitation was not performed in 161 cases (44%), performed in 14 (3%), and unknown or data missing for 192 (52%).ConclusionThis analysis found that CHAMPS cases assigned as stillbirth or neonatal death after DeCoDe expert panel review were generally consistent with the initial report of the case as a stillbirth or neonatal death. Our findings suggest that more frequent use of resuscitation at delivery and improvements in documentation around events at birth could help improve perinatal outcomes.

China Health Related Outcomes Measures (CHROME): Development of a New Generic Preference-Based Measure for the Chinese Population.

Background and ObjectivesExisting generic preference-based measures were all developed in Western countries. Evidence shows that the Chinese population may have different perceptions about health and health-related quality of life. This study aimed at developing a descriptive system of a new generic preference-based measure under the initiative of China Health Related Outcomes Measures (CHROME).MethodsQualitative data were collected through semi-structured interviews conducted in-person or online. Respondents were recruited from both the general public and populations with chronic diseases. Open-ended questions about the respondent’s perception of general health and important aspects of health-related quality of life were asked. Probing questions based on a systematic review of existing generic preference-based measures were also used. The framework analysis was used to synthesize the qualitative data. Candidate items for the descriptive system were selected following the ISPOR and COSMIN guidelines. Expert panel review and cognitive debriefings were conducted for further revisions.ResultsQualitative interviews were conducted among 68 respondents, with 48.5% male and a mean age of 47.8 years (range 18–81 years). In total, 1558 codes were identified and then aggregated to 31 sub-themes and corresponding six themes to inform the development of the initial version of the descriptive system. Feedback from the expert panel survey and meeting (n = 15) and the cognitive debriefing interviews (n = 30) was incorporated into the revised version of the measure. Finally, the generic version of CHROME (CHROME-G) included 12 items across six domains, namely, pain, fatigue, appetite, mobility, vision, hearing, sleeping, daily activities, depression, worry, memory, and social interactions. The descriptive system used a mix of four-level and five-level response options and a 7-day recall period.ConclusionsThe CHROME-G is the first generic preference-based measure to be developed based on the inputs from the Chinese populations.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40273-022-01151-9.

An Independent Assessment of a Commercial Clinical Interpretation Software Indicates That Software Can Mitigate Variation in Human Assessment

Comprehensive next-generation sequencing (NGS) panels for cancer diagnostics create a bottleneck for interpretation. QIAGEN Clinical Insights Interpret One (QCI) is a clinical decision support software that supports molecular pathologists in the classification of oncology-related variants. This study compares variant assessments by QCI to assessments utilizing current laboratory methods. Eight laboratories were recruited by the external quality assessment organization GenQA. The laboratories submitted VCFs from sequencing studies performed on both hematological disorders and solid tumors for analysis by QCI and an independent laboratory. Results were compared and conflicts were resolved using a panel of experts. In total, 14/149 variants (9%) reported as Tier 1 or Tier 2 by either QCI or the submitting laboratory were found to be discordant after expert panel review. In contrast, 41/149 variants (28%) reflected discrepancy among human reviewers. The expert panel was unable to reach resolution on eight variants. QCI demonstrates high concordance in the classification of actionable mutations with independent laboratory methods and expert assessment. The rate of disagreement among laboratories and the expert panel was greater than the disagreement between QCI and expert assessment. Disagreement among experts highlights the subjectivity of classifying variants. The study demonstrates that QCI interpretation supports streamlining and standardization of NGS variant interpretation.

Review of industry reports on EU priority tobacco additives part A: Main outcomes and conclusions.

The European Union Tobacco Products Directive (EU TPD) mandates enhanced reporting obligations for tobacco manufacturers regarding 15 priority additives. Within the Joint Action on Tobacco Control (JATC), a review panel of independent experts was appointed for the scientific evaluation of the additive reports submitted by a consortium of 12 tobacco manufacturers. As required by the TPD, the reports were evaluated based on their comprehensiveness, methodology and conclusions. In addition, we evaluated the chemical, toxicological, addictive, inhalation facilitating and flavoring properties of the priority additives based on the submitted reports, supplemented by the panel’s expert knowledge and some independent literature. The industry concluded that none of the additives is associated with concern. Due to significant methodological limitations, we question the scientific validity of these conclusions and conclude that they are not warranted. Our review demonstrates that many issues regarding toxicity, addictiveness and attractiveness of the additives have not been sufficiently addressed, and therefore concerns remain. For example, menthol facilitates inhalation by activation of the cooling receptor TRPM8. The addition of sorbitol and guar gum leads to a significant increase of aldehydes that may contribute to toxicity and addictiveness. Titanium dioxide particles (aerodynamic diameter <10 µm) are legally classified as carcinogenic when inhaled. For diacetyl no report was provided. Overall, the industry reports were not comprehensive, and the information presented provides an insufficient basis for the regulation of most additives. We, therefore, advise MS to consider alternative approaches such as the precautionary principle.

Competency assessment for community health nurses: a focus group expert panel discussion

BackgroundGeneral Practice setting in the Primary Health Care Services are the utmost visited by the public. It is important that the nurses’ competencies in this area be assessed to ensure provision of safe and quality services.Aim/objectiveTo explore perceptions and experiences of competencies assessment tool for community health nurses working at the General Practice setting in the Primary Health Care Services.MethodsAn exploratory qualitative study utilizing focus group discussions were conducted on purposive sample of 12 officers with expertise in competency assessment and community health nursing from higher nursing education institutions, the Nursing Training and Development Centre, the Nursing Board and the Community Health Nursing Services in Brunei Darussalam. The existing competencies assessment tool was revised, the participants were divided into two groups of expert panel review team and two focus group discussions were held with each team. The focus group discussions encompassed components and methods of assessment; methods of grading; and overall organization and structure of the revised competency assessment tool.FindingsFour themes emerged: 1) International equivalent core competencies components; 2) Multi-methods approach to assessment; 3) Definitive guidelines as framework for assessment; and 4) Understanding and acceptability of the competency assessment tool.Conclusions/implications to practiceThe expert panel reviews provide practical input that were inculcated in the preliminary developed competencies assessment tool. Identification of eligible assessors were recommended based on standardized criteria, and socialization and training held to set direction and guidance for implementing the utilization of the competencies assessment tool. Further studies are deemed important to critically evaluate and validate the preliminary competencies assessment tool for development of a more robust assessment instrument.

Developing Assessments to Gauge Biomolecular Visual Literacy: A 5 step approach to ensuring accuracy and reliability

BioMolViz is a community of educators, assessment experts, and biomolecular visualization enthusiasts dedicated to improving biomolecular visual literacy. A central goal of the project is to create a repository of validated assessments that instructors can use in their classrooms to gauge students’ visual literacy. Through three‐day workshops, we convene faculty to craft and peer review biomolecular visualization assessments in teams. These workshops are often the first step in our assessment development process. In this presentation, we will describe a five‐step model for designing and validating assessments that consists of: 1. Item creation 2. Item revision 3. Expert panel review 4. Field testing and 5. Dissemination through the online BioMolViz repository. Results from the first three phases of the process will be reported, and our plan for field testing and disseminating assessments will be discussed. In 2020, our workshops and assessment development model moved online, which opened up new pathways for sustained engagement with workshop participants. In particular, we will share how a new working group emerged when we established our remote workflow. A subset of the group, The BioMolViz Fellows, continued working with our community for several semesters and has become integral to the iterative assessment revision process. Alongside our validation process, we will highlight insights for building online communities, establishing remote workflows, and sustaining long‐term participant engagement.

Recent SARS-CoV-2 infection: too early to vaccinate?

Recent SARS-CoV-2 infection: too early to vaccinate?

Perspectives on competencies for care in austere settings

Austerity in surgical care may manifest by limited equipment/supplies, deficient infrastructure (power, water), rationing/triage requirements, or the unavailability of specialty surgical or medical expertise. Some settings in which surgeons may experience austerity include the following: military deployed operations (domestic and foreign), humanitarian surgical missions, care in rural or remote settings, mass-casualty events, natural disasters, and/or care in low- and some middle-income countries. Expanded competencies beyond those required in routine surgical practice can optimize the quality of surgical care in such settings. The purpose of this expert panel review is to introduce those competencies.

Development of the Abbreviated Technology Anxiety Scale (ATAS).

The purpose of this research was to develop a short measure of technology anxiety and provide validity and reliability evidence for its use in a variety of studies in the social sciences. Technology anxiety is an emotion oriented towards a negative affect leading to the avoidance of information and communication technology (Wilson, 2018). We developed the Abbreviated Technology Anxiety Scale (ATAS) and applied measurement theory to provide validity and reliability evidence. We implemented the study in multiple phases that included expert panel reviews on the content and quality of the items, and three rounds of data collection and analyses to provide the needed evidence. The scores from the ATAS were found to have an internally consistent structure, as well as to correlate with other known measures of technology and anxiety. Our results support the use of the ATAS for low-stakes purposes in research studies and evaluations. A general discussion is provided looking at the potential applications of the ATAS and its relation to other existing measures.

A Post-Marketing Study of Pethidine in Indonesia: Safety Profile

Introduction&#x0D; Pethidine along with morphine and tramadol, is one of the frequently used drugs for postoperative pain management. It is important to ensure the safety of the product and ultimately the safety of the patients as users of the pethidine.&#x0D; Methods&#x0D; A post marketing surveillance study was conducted with a retrospective cross-sectional design using medical records and hospital pharmacy’s data in patients who were admitted to inpatient or emergency department of Dr. Sardjito General Hospital Yogyakarta between January and December 2016. The data was analyzed descriptively to estimate the proportion of adverse events (AEs) including serious adverse events (SAE).&#x0D; Results&#x0D; Of the 576 patients hospitalized at the at the Dr. Sardjito General Hospital, 200 medical records were selected using consecutive sampling method. A total of 120 of the 200 subjects were found to have 245 any Adverse Events (AE) including Serious Adverse Events (SAE) following the administration of pethidine. There were 23 classifications of expected AE and 148 classifications of unexpected AE following the administration of pethidine. The duration of AE/SAE found ranged from 0 to 11 days. A total of 101 (50.5%) and 85 (42.5%) subjects experienced AE/SAE with duration &lt;24 hours and between 1 to 2 days, respectively. The longest duration of event was pain with duration of 11 days. There were 23 types of expected AE/SAE from pethidine found in subjects, with the highest number of expected AE/SAE were weakness, vomiting, and dizziness of 24 (25%), 16 (16.8%), and 10 (10.5%), respectively. The expert panel team concluded five types of unexpected SAEs which are possible to pethidine, including respiratory acidosis, urinary tract infections, acute kidney injury, icteric, and electrolyte imbalance.&#x0D; Conclusion&#x0D; A post-marketing surveillance study provides safety profile of 50 mg / ml pethidine in Indonesia. A total of 120 of the 200 subjects who received pethidine experienced 245 Adverse Events (AEs) or Serious Adverse Events (SAEs). AEs/SAEs were divided into 23 types of expected events and 148 types of unexpected events. Few numbers of SAEs were considered possible related to the pethidine according to expert panel review.&#x0D; &#x0D; Keywords: pethidine, meperidine, post-marketing, pharmacovigilance

Measuring social norms and attitudes about age-disparate transactional sex: Psychometric testing of the NAATSS

Transactional sex between girls under 18 years-old and adult men at least ten years older, known as age-disparate transactional sex (ADTS), is an established risk factor for HIV, STI and early pregnancy among girls and women. Social norms or beliefs about what others expect from you and what others do can sustain behaviours such as ADTS even when individuals may be personally against them. In order to evaluate interventions to change social norms, validated instruments for measuring change in personal beliefs and social norms regarding ADTS are needed. Items for the Norms and Attitudes on Age-Disparate Transactional Sex Scale (NAATSS) were generated based on qualitative interviews and expert panel review. The reliability and validity of the NAATSS was tested in a representative sample (N=431) from Brazilian favelas. Factor analysis assessed construct validity, Cronbach's alpha assessed reliability, and t-tests and analysis of variances tested hypothesized differences between gender, age, and previous experience with ADTS in both the social norms and personal beliefs domains. Factor analysis revealed three factors in each domain. The factors were labelled "Attributions to Girls' Behaviour" which has 5 items, "Men's Motivations" with 5 items, and "Girls' Readiness to have Sex" with 3 items. The subscales evidenced acceptable reliability with Cronbach's alphas ranging from 0.72 to 0.83 for the social norms subscales and 0.59 to 0.82 for the personal beliefs subscales. The items were developed based on qualitative research and expert rankings and the resulting Norms and Attitudes on ADTS Scale exhibits strong psychometric properties. Each of the three subscales within the two domains illustrate good factor structure, acceptable internal consistency reliability, and are supported by the significance of the hypothesized group differences. This work was supported by the OAK Foundation [grant number OCAY-16-188].