Standard Operational Definition Research Articles

Community member attitudes and understanding of "serious mental illness": A mixed-method study.

"Serious mental illness" (SMI) is a priority population within mental health treatment and policy. However, there is no standard operational definition across research, clinical, and policy contexts. The use of the label has also not been evaluated regarding its association with stigma among the general public. This mixed-method study compared community members' stigma toward "SMI" with other psychiatric labels and examined community understanding and perceptions of the SMI label. Two hundred forty-six participants recruited via Prolific read randomly manipulated vignettes describing an individual diagnosed with depression, schizophrenia, or "SMI" and completed measures of stigma and qualitative questions regarding familiarity, understanding, and perceived utility of SMI. Quantitative analyses evaluated stigma across vignettes, and qualitative analyses identified common themes across responses. Stigma was relatively high across vignettes, with more negative views reported toward SMI and schizophrenia compared with depression. Quantitative differences in stigma by vignette were not significant after controlling for participants' age and gender. Qualitative responses were split regarding the perceived utility of the SMI term, with noted concerns including its broadness and potential for stigma. Most participants described functional impairment or disability as characteristic of "SMI," and approximately 70% associated schizophrenia and psychotic disorders with "SMI" compared with 45% for depression. Person-level factors were more strongly associated with stigma than psychiatric labels. However, our sample described concerns that the SMI term is vague and may exacerbate stigma. Community education and antistigma efforts should move beyond diagnostic labels in characterizing mental illness to facilitate change in attitudes. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Outcomes of Unplanned Extubations in a Large Children's Hospital.

Unplanned extubation (UE) is defined as unintentional dislodgement of an endotracheal tube (ETT) from the trachea. UEs can lead to instability, cardiac arrest, and may require emergent tracheal re-intubation. As part of our hospital-wide quality improvement (QI) work, a multidisciplinary committee reviewed all UEs to determine contributing factors and evaluation of clinical outcomes to develop QI interventions aimed to minimize UEs. The objective was to investigate occurrence, contributing factors, and clinical outcomes of UEs in the pediatric ICU (PICU), cardiac ICU (CICU), and neonatal ICU (NICU) in a large academic children's hospital. We hypothesized that these would be substantially different across 3 ICUs. A single-center retrospective review of UEs in the PICU, CICU, and NICU was recorded in a prospective database for the last 5 y. Consensus-based standardized operational definitions were developed to capture contributing factors and adverse events associated with UEs. Data were extracted through electronic medical records by 3 respiratory therapists and local Virtual Pediatric Systems (VPS) database. Consistency of data extraction and classification were evaluated. From January 2016-December 2021, 408 UEs in 339 subjects were reported: PICU 52 (13%), CICU 31 (7%), and NICU 325 (80%). The median (interquartile range) of age and weight was 2.0 (0-4.0) months and 5.3 (3.0-8.0) kg. Many UE events were not witnessed (54%). Common contributing factors were routine nursing care (no. = 70, 18%), ETT retaping (no. = 62, 16%), and being held (no. = 15, 3.9%). The most common adverse events with UE were desaturation < 80% (33%) and bradycardia (22.8%). Cardiac arrest occurred in 12%. Sixty-seven percent of UEs resulted in re-intubation within 72 h. The proportion of re-intubation across 3 units was significantly different: PICU 62%, CICU 35%, NICU 71%, P < .001. UEs occurred commonly in a large academic children's hospital. Whereas UE was associated with adverse events, re-intubation rates within 72 h were < 70% and variable across the units.

Evaluation of Within- and Between-Site Agreement for Direct Observation of Physical Behavior Across Four Research Groups

Direct observation (DO) is a widely accepted ground-truth measure, but the field lacks standard operational definitions. Research groups develop project-specific annotation platforms, limiting the utility of DO if labels are not consistent. Purpose: The purpose was to evaluate within- and between-site agreement for DO taxonomies (e.g., activity intensity category) across four independent research groups who have used video-recorded DO. Methods: Each site contributed video files (508 min) and had two trained research assistants annotate the shared video files according to their existing annotation protocols. The authors calculated (a) within-site agreement for the two coders at the same site expressed as intraclass correlation and (b) between-site agreement, the proportion of seconds that agree between any two coders regardless of site. Results: Within-site agreement at all sites was good–excellent for both activity intensity categories (intraclass correlation range: .82–.9) and posture/whole-body movement (intraclass correlation range: .77–.98). Between-site agreement for intensity categories was 94.6% for sedentary, 80.9% for light, and 82.8% for moderate–vigorous. Three of the four sites had common labels for eight posture/whole-body movements and had within-site agreements of 94.5% and between-site agreements of 86.1%. Conclusions: Distinct research groups can annotate key features of physical behavior with good-to-excellent interrater reliability. Operational definitions are provided for core metrics for researchers to consider in future studies to facilitate between-study comparisons and data pooling, enabling the deployment of deep learning approaches to wearable device algorithm calibration.

Increasing the accuracy of the asthma diagnosis using an operational definition for asthma and a machine learning method

IntroductionAnalysis of the National Health Insurance data has been actively carried out for the purpose of academic research and establishing scientific evidences for health care service policy in asthma. However, there has been a limitation for the accuracy of the data extracted through conventional operational definition. In this study, we verified the accuracy of conventional operational definition of asthma, by applying it to a real hospital setting. And by using a machine learning technique, we established an appropriate operational definition that predicts asthma more accurately.MethodsWe extracted asthma patients using the conventional operational definition of asthma at Seoul St. Mary’s hospital and St. Paul’s hospital at the Catholic University of Korea between January 2017 and January 2018. Among these extracted patients of asthma, 10% of patients were randomly sampled. We verified the accuracy of the conventional operational definition for asthma by matching actual diagnosis through medical chart review. And then we operated machine learning approaches to predict asthma more accurately.ResultsA total of 4,235 patients with asthma were identified using a conventional asthma definition during the study period. Of these, 353 patients were collected. The patients of asthma were 56% of study population, 44% of patients were not asthma. The use of machine learning techniques improved the overall accuracy. The XGBoost prediction model for asthma diagnosis showed an accuracy of 87.1%, an AUC of 93.0%, sensitivity of 82.5%, and specificity of 97.9%. Major explanatory variable were ICS/LABA,LAMA and LTRA for proper diagnosis of asthma.ConclusionsThe conventional operational definition of asthma has limitation to extract true asthma patients in real world. Therefore, it is necessary to establish an accurate standardized operational definition of asthma. In this study, machine learning approach could be a good option for building a relevant operational definition in research using claims data.

Variations in the patterns of tobacco usage among indian females - findings from the global adult tobacco survey India

BackgroundMales dominate in tobacco usage, as well as in tobacco research, knowing that women face more severe health consequences. There is a specific lack of information on epidemiological statistics, risks, and the level of knowledge among women regarding tobacco. This study examines the Global Adult Tobacco Survey (GATS)-India dataset to estimate female tobacco usage and assess socio-economic variations in tobacco consumption, awareness regarding the adverse effects of tobacco, noticing pack health warnings (PHW), and intention to quit tobacco use well as factors influencing these domains.MethodsUsing a geographically clustered multistage sampling method, the nationally representative GATS II (2016–17) interviewed 40,265 female respondents aged 15 years and above from all Indian states and union territories. Standard operational definitions were used to estimate the primary independent variables (community, individual, and household categories) and dependent variables like awareness regarding the adverse effects of tobacco, noticing pack health warning (PHW), and intention to quit tobacco. Sampling weights were adjusted while performing the analysis. Bivariate and multivariable analysis were used to generate the estimates.ResultsOf the total female respondents, 84.2% were never-users, 13.3% ever consumed Smokeless Tobacco (SLT) products, 1.8% ever smoked tobacco, and 0.8% were dual users once in their lives. Around 16% of the women had exposure to Second Hand Smoke (SHS) either at their homes, workplaces or in public places. Overall, maximum awareness was seen among non-smoker females (64.7%) and dual users (64.7%), followed by women exposed to SHS, SLT users, and smokers. PHW was noticed more by the bidi smokers, followed by SLT users and cigarette smokers. Factors that positively affected intention to quit smoking included younger age, secondary school education, self-employed status, the habit of buying packed cigarettes/bidi, believing that smoking causes serious illness, and attempted quitting in the last 12 months.ConclusionA high proportion of women consume tobacco which is significantly influenced by socio-demographic factors. Tobacco regulators should be especially concerned about women as the tobacco marketing experts target them. Mobilizing self-help groups and organizations working for women and children could assist broader campaigns to generate awareness and motivate quitting attempts.

Systematic Review and Meta-analysis: An Empirical Approach to Defining Treatment Response and Remission in Pediatric Obsessive-Compulsive Disorder.

A lack of universal definitions for response and remission in pediatric obsessive-compulsive disorder (OCD) has hampered the comparability of results across trials. To address this problem, we conducted an individual participant data diagnostic test accuracy meta-analysis to evaluate the discriminative ability of the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) in determining response and remission. We also aimed to generate empirically derived cutoffs on the CY-BOCS for these outcomes. A systematic review of PubMed, PsycINFO, Embase and CENTRAL identified 5,401 references; 42 randomized controlled clinical trials were considered eligible, and 21 provided data for inclusion (N = 1,234). Scores of≤2 in the Clinical Global Impressions Improvement and Severity scales were chosen to define response and remission, respectively. A 2-stage, random-effects meta-analysis model was established. The area under the curve (AUC) and the Youden Index were computed to indicate the discriminative ability of the CY-BOCS and to guide for the optimal cutoff, respectively. The CY-BOCS had sufficient discriminative ability to determine response (AUC= 0.89) and remission (AUC= 0.92). The optimal cutoff for response was a≥35% reduction from baseline to posttreatment (sensitivity= 83.9, 95% CI= 83.7-84.1; specificity= 81.7, 95% CI= 81.5-81.9). The optimal cutoff for remission was a posttreatment raw score of≤12 (sensitivity= 82.0, 95% CI= 81.8-82.2; specificity= 84.6, 95% CI= 84.4-84.8). Meta-analysis identified empirically optimal cutoffs on the CY-BOCS to determine response and remission in pediatric OCD randomized controlled clinical trials. Systematic adoption of standardized operational definitions for response and remission will improve comparability across trials for pediatric OCD.

Risk Factors Associated With Transition From Acute to Chronic Low Back Pain in US Patients Seeking Primary Care

Acute low back pain (LBP) is highly prevalent, with a presumed favorable prognosis; however, once chronic, LBP becomes a disabling and expensive condition. Acute to chronic LBP transition rates vary widely owing to absence of standardized operational definitions, and it is unknown whether a standardized prognostic tool (ie, Subgroups for Targeted Treatment Back tool [SBT]) can estimate this transition or whether early non-guideline concordant treatment is associated with the transition to chronic LBP. To assess the associations between the transition from acute to chronic LBP with SBT risk strata; demographic, clinical, and practice characteristics; and guideline nonconcordant processes of care. This inception cohort study was conducted alongside a multisite, pragmatic cluster randomized trial. Adult patients with acute LBP stratified by SBT risk were enrolled in 77 primary care practices in 4 regions across the United States between May 2016 and June 2018 and followed up for 6 months, with final follow-up completed by March 2019. Data analysis was conducted from January to March 2020. SBT risk strata and early LBP guideline nonconcordant processes of care (eg, receipt of opioids, imaging, and subspecialty referral). Transition from acute to chronic LBP at 6 months using the National Institutes of Health Task Force on Research Standards consensus definition of chronic LBP. Patient demographic characteristics, clinical factors, and LBP process of care were obtained via electronic medical records. Overall, 5233 patients with acute LBP (3029 [58%] women; 4353 [83%] White individuals; mean [SD] age 50.6 [16.9] years; 1788 [34%] low risk; 2152 [41%] medium risk; and 1293 [25%] high risk) were included. Overall transition rate to chronic LBP at six months was 32% (1666 patients). In a multivariable model, SBT risk stratum was positively associated with transition to chronic LBP (eg, high-risk vs low-risk groups: adjusted odds ratio [aOR], 2.45; 95% CI, 2.00-2.98; P < .001). Patient and clinical characteristics associated with transition to chronic LBP included obesity (aOR, 1.52; 95% CI, 1.28-1.80; P < .001); smoking (aOR, 1.56; 95% CI, 1.29-1.89; P < .001); severe and very severe baseline disability (aOR, 1.82; 95% CI, 1.48-2.24; P < .001 and aOR, 2.08; 95% CI, 1.60-2.68; P < .001, respectively) and diagnosed depression/anxiety (aOR, 1.66; 95% CI, 1.28-2.15; P < .001). After controlling for all other variables, patients exposed to 1, 2, or 3 nonconcordant processes of care within the first 21 days were 1.39 (95% CI, 1.21-2.32), 1.88 (95% CI, 1.53-2.32), and 2.16 (95% CI, 1.10-4.25) times more likely to develop chronic LBP compared with those with no exposure (P < .001). In this cohort study, the transition rate to chronic LBP was substantial and increased correspondingly with SBT stratum and early exposure to guideline nonconcordant care.

Vascular endothelial dysfunction may be an early predictor of physical frailty and sarcopenia: A meta-analysis of available data from observational studies.

Physical frailty and sarcopenia (PF & S) are major public health problems in the older population and promising predictors of adverse cardiovascular outcomes. However, the underlying mechanisms linking physical frailty, sarcopenia and adverse cardiovascular outcomes are not well defined. We recently published a systematic review which highlighted early-stage vascular endothelial dysfunction (VED) as one of the potential underlying mechanisms of physical frailty and the role of inflammation in modulating this association. A meta-analysis was performed to estimate the pooled effect size of studies examining the relationship between VED and PF & S. Out of 18 cross-sectional studies selected for the original review, 13 studies were excluded due to lack of available data for pooled analysis. The five remaining studies had a total of 6616 participants, of which the pooled sample size of the frail or sarcopenic cohort was 607 and robust or pre-frail or non-sarcopenic cohort was 6009. Mean age of the participants ranging from 64 to 80years or over. In this analysis, high heterogeneity was observed among studies (99.35% of the variation between studies was due to heterogeneity). Parameters used to assess both PF & S and VED were very different across the studies. The absence of a standardized and valid operational definition of frailty and sarcopenia is a principal limiting factors for frailty research and this is clearly reflected in our study findings. This limits the ability to interpret and define the effects of vascular endothelial dysfunction on these different parameters of frailty and sarcopenia. Similarly, assessment of vascular endothelial dysfunction was very heterogeneous with different parameters utilized across these studies.

Parental perceived child sleep problems: A concept analysis.

This paper aims to delineate a conceptual analysis of parental perceived child sleep problems. Rodger's evolutionary approach to concept analysis was employed. A systematic literature search of PubMed, CINAHL, Medline, and PsycINFO was conducted from inception to June 2020. Peer-reviewed papers written in English focusing on parental perception of their children's sleep problems were included. A total of 47 papers were included for analysis. Parental perceived child sleep problems can be defined as parental reliance on their observations and beliefs, and perceived locus of control to appraise an array of children's sleep-related signs and behaviors, which may contain bias but still reflects certain aspects of children's sleep health status. A wide range of physiological, psychosocial, familial, environmental, and cultural factors may contribute to parental perceived child sleep problems, which may further contribute to parent-child dyads' physical and mental health as well as the whole family's general wellness. Defining the concept of parental perceived child sleep problems facilitate health professionals a foundation for consistent use, understanding, and evaluation of parent-reported child sleep outcome. Future research on the standard conceptual and operational definition of parental perceived child sleep problem, and its potential antecedents and consequences is warranted. The characteristic of parental perceived sleep problems, together with child sleep history and objective sleep measures should be integrated to evaluate child sleep health.

Operational Definitions for Chronic Liver Disease Manifestations and Recurring Clinical Events in Biliary Atresia.

The disease course of biliary atresia (BA) may be complicated by development of chronic liver disease (CLD) manifestations (eg, ascites) and recurring clinical events (eg, cholangitis). Most pediatric CLD-manifestations/events lack standardized operational definitions, leading to inconsistent identification in clinical research. This study aimed to develop operational research definitions of CLD-manifestations/events in BA for application in retrospective analysis. Operational definitions of CLD-manifestations/events were developed by literature review and revised by a panel of experienced pediatric hepatologists. Definitions were applied to a single-center review of infants with BA post-Kasai. Manifestations/events were captured until last clinical visit with native liver (SNL), liver transplantation (LT), or death. Native liver survival and event-free survival were estimated by Kaplan-Meier method. Cluster analysis was performed to identify similar patterns of manifestation/event development. Of 65 infants with BA post-Kasai (2006-18; median Kasai 56.8 days; 65% girls), 29 underwent LT (median 12.9 months) and 4 died without LT (median 6.9 months). Seventy-six percent of CLD-manifestations/events presented within the first year. Presence of definite clinically evident portal hypertension, thrombocytopenia, and dCE ascites were associated with poor transplant-free survival (P < 0.01). Similar pattern developments of CLD-manifestations/events identified 3 outcome groups: poor outcomes (87.8% LT/death), SNL with manifestations/events, and SNL with few/no events. Operational definitions can provide a timely description of the disease course progression in infants with BA. Research definitions may provide better consistency in future pediatric CLD studies. Furthermore, definitions may serve as endpoints in therapeutic trials or used as variables for disease pattern identification in potential multicenter studies.

The 5Ts for Teach Back: An Operational Definition for Teach-Back Training

Background:Teach Back is a health communication strategy used to confirm patient understanding in a non-shaming way. Although Teach Back is widely recommended as a best practice strategy for improving patient outcomes and organizational health literacy, there is lack of consensus in the literature on the definition of Teach Back and the best methods for training health care workers (HCWs). Our experience suggests that if you teach specific, observable skills, these can be identified in practice and potentially measured in research.Brief description of activity:We created a training program, the 5Ts for Teach Back, based on a standardized operational definition of Teach Back and five specific, observable components. Participants use a Teach-Back Observation Tool to identify the 5Ts in practice and during peer evaluation. The program incorporates lecture, observation, practice, and videos with good and bad examples of Teach Back.Implementation:The training was offered to HCWs in a large academic health care system. Flexible training options ranged from a single 4-hour training to a more comprehensive program that included clinic-specific scenarios, peer coaching, and refresher activities over a 6-month period.Results:The 5Ts for Teach Back operationalizes the definition of Teach Back and provides a model for training HCWs in the use of Teach Back. The 5Ts for Teach Back can be used to train any HCW. A single training session does not guarantee proficiency in practice. Through coaching and refresher activities, competence in Teach Back increases.Lessons learned:Teaching entire clinical units may increase effectiveness, because Teach Back becomes embedded in the unit culture. The Observation Tool can be used for training, coaching, and evaluation. The standardized method and Observation Tool are potentially useful when evaluating Teach Back during outcomes and patient satisfaction research. [HLRP: Health Literacy Research and Practice. 2020;4(2):94–103.]Plain Language Summary:Health care workers may be clearer when giving information to patients if they use Teach Back. Studies do not show what methods are best for training health care workers how to do Teach Back. The 5Ts method breaks Teach Back into five skills that help health care workers do it well. The 5Ts can also confirm use and may be helpful for research.

Frequency of Pediatric Acute Respiratory Distress Syndrome Based on Oxygen Saturation Index in Pediatric Intensive Care Unit of a Developing Country.

ObjectivesTo determine the frequency of pediatric acute respiratory distress syndrome based on oxygen saturation index in pediatric intensive care unit of a developing country.MethodsWe conducted a retrospective study of all children admitted in pediatric intensive care unit (PICU) of Aga Khan University Hospital, Karachi from July 2017 to June 2018 with respiratory rate >40 breaths/minute, shortness of breath, and bluish discoloration of skin and mucous membranes. The diagnosis of acute respiratory distress syndrome (ARDS) was made on the basis of standard operational definitions as mentioned (fulfilling criteria for ARDS).ResultsDuring the one-year study period 150 patients with age range of one month to 16 years were admitted fulfilling the inclusion criteria. Mean age was 38.27 ± 53.13 months, and 92 (61.33%) were male with male to female ratio of 1.6:1. Mean duration of symptoms was 1.23 ± 0.42 days. Frequency of pediatric acute respiratory distress syndrome using oxygen saturation index admitted in a pediatric ICU was 23 (15.33%) patients.ConclusionThis study has shown that the frequency of pediatric acute respiratory distress syndrome is quite high.

Nationwide validation study of diagnostic algorithms for inflammatory bowel disease in Korean National Health Insurance Service database.

We conducted a nationwide validation study of diagnostic algorithms to identify cases of inflammatory bowel disease (IBD) within the Korea National Health Insurance System (NHIS) database. Using the NHIS dataset, we developed 44 algorithms combining the International Classification of Diseases (ICD)-10 codes, codes for Rare and Intractable Diseases (RID) registration and claims data for health care encounters, and pharmaceutical prescriptions for IBD-specific drugs. For each algorithm, we compared the case identification results from electronic medical records data with the gold standard (chart-based diagnosis). A multiple sampling test verified the validation results from the entire study population. A random nationwide sample of 1697 patients (848 potential cases and 849 negative control cases) from 17 hospitals were included for validation. A combination of the ICD-10 code, ≥1 claims for health care encounters, and ≥1 prescription claims (reference algorithm) achieved excellent performance (sensitivity, 93.1% [95% confidence interval 91-94.7]; specificity, 98.1% [96.9-98.8]; positive predictive value, 97.5% [96.1-98.5]; negative predictive value, 94.5% [92.8-95.8]) with the lowest error rate (4.2% [3.3-5.3]). The multiple sampling test confirmed that the reference algorithm achieves the best performance regarding IBD diagnosis. Algorithms including the RID registration codes exhibited poorer performance compared with that of the reference algorithm, particularly for the diagnosis of patients affiliated with secondary hospitals. The performance of the reference algorithm showed no statistical difference depending on the hospital volume or IBD type, with P-value<0.05. We strongly recommend the reference algorithm as a uniform standard operational definition for future studies using the NHIS database.

Setting definitions of childhood asthma in epidemiologic studies

The definitions of childhood asthma differ among epidemiological studies. We aimed to compare the diagnostic accuracy and agreement of previous asthma definitions and to evaluate questionnaire-driven asthma definition patterns. Data on 808 participants aged 7-12years from 20 schools were analyzed. Asthma definitions based on symptoms assessed by questionnaire, parent-reported medical asthma diagnosis, current use of asthma medication, airway reversibility after bronchodilatation, and increased (≥35ppb) levels of exhaled nitric oxide (eNO) were compared with a gold standard (medical diagnosis of asthma with asthma symptoms in the past 12months and/or airway reversibility). Concordance was assessed by Cohen's kappa. Data-driven analysis was applied to the questionnaire, and six scores were determined "asthma," "rhinitis," "cough," "non-specific respiratory symptoms," "treated asthma," and "uncontrolled asthma." Tree decisions were built using these scores. Definitions of asthma based on respiratory symptoms, airway reversibility, and parent-reported medical diagnosis had a low sensitivity but high specificity. Agreement between reported and objective measures was poor. Parent-reported medical asthma diagnosis, but not reversibility or eNO, was able to predict questionnaire-driven symptom patterns. Decision trees indicated that those with recent non-specific respiratory symptoms had a higher probability of positive bronchodilation. A standardized operational definition of asthma should include a composite score based on reported asthma medical diagnosis, symptoms, and lung function.

RW2 RETROSPECTIVE REAL-WORLD ASSESSMENT OF RESPONSE OUTCOMES IN ONCOLOGY

Clinical trial efficacy endpoints for treatments in oncology traditionally include Response Evaluation Criteria in Solid Tumors (RECIST) response assessments, including objective response rate (ORR), best overall response (BOR), and duration of response (DOR). This requires precise measurement of tumor sizes from imaging tests. Increasingly, there is value in assembling these endpoints using real-world data and study designs particularly in rare tumor types or where a randomized controlled trial (RCT) design is not viable. Our objective is to describe methodologic considerations and factors affecting interpretation of response outcomes in prospective RCTs versus real-world retrospective studies. Data from electronic health records were collected to calculate response endpoints for retrospective observational studies. Operational definitions were used to classify treatment response based on data type and whether assessments were clinical, physician-assessed response, or radiographic tumor measurements similar to RECIST. Educational materials and case report forms were developed. Sensitivity analysis were performed to assess how data variations affected results. Collection and interpretation of real-world treatment response was influenced by the number of patients with available data; frequency of assessments including office visits or imaging tests; types of imaging tests; availability of baseline and follow-up tests; and reporting of target lesion sizes. Difference in response rates were observed depending on availability and timing of data. Real-world response data can provide valuable information. Unlike standardized assessments in clinical trials, variability exists in clinical practice. Response measurements may be influenced by factors including physician or patient preferences, disease severity, payer coverage, and scheduling. Results may differ from RCTs, underscoring the importance of standardized operational definitions and timing of assessments to aid interpretation of results. This is also important as immunotherapies and new methods such as Immune-Modified Response Evaluation Criteria In Solid Tumors (imRECIST) are developed.

Frailty in surgical patients.

To describe the current definitions, aetiology, assessment tools and clinical implications of frailty in modern surgical practice. Frailty is a critical issue in modern surgical practice due to its association with adverse health events and poor post-operative outcomes. The global population is rapidly ageing resulting in more older patients presenting for surgery. With this, the number of frail patients presenting for surgery is also increasing. Despite the identification of frailty as a significant predictor of poor health outcomes, there is currently no consensus on how to define, measure and diagnose this important syndrome. Relevant references were identified through keyword searches of the Cochran, MEDLINE and EMbase databases. Despite the lack of a gold standard operational definition, frailty can be conceptualised as a state of increased vulnerability resulting from a decline in physiological reserve and function across multiple organ systems, such that the ability to withstand stressors is impaired. Multiple studies have shown a strong association between frailty and adverse peri-operative outcomes. Frailty may be assessed using multiple tools; however, the ideal tool for use in a clinical setting has yet to be identified. Despite the association between frailty and adverse outcomes, few interventions have been shown to improve outcomes in these patients. Frailty encompasses a group of individuals at high risk of adverse post-operative outcomes. Further work exploring ways to optimally assess and target interventions towards these patients should be the focus of ongoing research.

Frequency of Desaturation and Association With Hemodynamic Adverse Events During Tracheal Intubations in PICUs.

Oxygen desaturation during tracheal intubation is known to be associated with adverse ICU outcomes in critically ill children. We aimed to determine the occurrence and severity of desaturation during tracheal intubations and the association with adverse hemodynamic tracheal intubation-associated events. Retrospective cohort study as a part of the National Emergency Airway Registry for Children Network's quality improvement project from January 2012 to December 2014. International PICUs. Critically ill children younger than 18 years undergoing primary tracheal intubations in the ICUs. tracheal intubation processes of care and outcomes were prospectively collected using standardized operational definitions. We defined moderate desaturation as oxygen saturation less than 80% and severe desaturation as oxygen saturation less than 70% during tracheal intubation procedures in children with initial oxygen saturation greater than 90% after preoxygenation. Adverse hemodynamic tracheal intubation-associated event was defined as cardiac arrests, hypo or hypertension requiring intervention, and dysrhythmia. A total of 5,498 primary tracheal intubations from 31 ICUs were reported. Moderate desaturation was observed in 19.3% associated with adverse hemodynamic tracheal intubation-associated events (9.8% among children with moderate desaturation vs 4.4% without desaturation; p < 0.001). Severe desaturation was observed in 12.9% of tracheal intubations, also significantly associated with hemodynamic tracheal intubation-associated events. After adjusting for patient, provider, and practice factors, the occurrence of moderate desaturation was independently associated with hemodynamic tracheal intubation-associated events: adjusted odds ratio 1.83 (95% CI, 1.34-2.51; p < 0.001). The occurrence of severe desaturation was also independently associated with hemodynamic tracheal intubation-associated events: adjusted odds ratio 2.16 (95% CI, 1.54-3.04; p < 0.001). Number of tracheal intubation attempts was also significantly associated with the frequency of moderate and severe desaturations (p < 0.001). In this large tracheal intubation quality improvement database, we found moderate and severe desaturation are reported among 19% and 13% of all tracheal intubation encounters. Moderate and severe desaturations were independently associated with the occurrence of adverse hemodynamic events. Future quality improvement interventions may focus to reduce desaturation events.

Development of a consensus operational definition of child assent for research

BackgroundThere is currently no consensus from the relevant stakeholders regarding the operational and construct definitions of child assent for research. As such, the requirements for assent are often construed in different ways, institutionally disparate, and often conflated with those of parental consent. Development of a standardized operational definition of assent would thus be important to ensure that investigators, institutional review boards, and policy makers consider the assent process in the same way. To this end, we describe a Delphi study that provided consensus from a panel of expert stakeholders regarding the definitions of child assent for research.MethodsBased on current guidelines, a preliminary definition of assent was generated and sent out for review to a Delphi panel including pediatric bioethicists and researchers, Institutional Review Board members, parents, and individuals with regulatory/legal expertise. For each subsequent review, the process of summarizing and revising responses was repeated until consensus was achieved. Panelists were also required to rank order elements of assent that they believed were most important in defining the underlying constructs of the assent process (e.g., capacity for assent, disclosure). In providing these rankings, panelists were asked to frame their responses in the contexts of younger (≤ 11 yrs) and adolescents/older children (12-17 yrs) in non-therapeutic and therapeutic trials. Summary rankings of the most important identified elements were then used to generate written construct definitions which were sent out for iterative reviews by the expert panel.ResultsConsensus regarding the operational definition was reached by 14/18 (78%) of the panel members. Seventeen (94%) panelists agreed with the definitions of capacity for assent, elements of disclosure for younger children, and the requirements for meaningful assent, respectively. Fifteen (83%) members agreed with the elements of disclosure for adolescents/older children.ConclusionsIt is hoped that this study will positively inform and effect change in the way investigators, regulators, and IRBs operationalize the assent process, respect children’s developing autonomy, and in concert with parental permission, ensure the protection of children who participate in research.

Measuring medication adherence: standardized definitions are needed to allow for comparisons

ABSTRACTObjectivesThough pharmacy claims data are commonly used to study medication adherence, there remains no standard operational definition for adherence especially for patients on multiple medications. Even when studies use the same terminology, the actual methods of calculating adherence can differ drastically. It is unclear whether the use of different definitions results in different conclusions regarding adherence and associated outcomes. The objective of our study was to compare adherence rates and associations with mortality using different operational definitions of adherence, and using various methods of handling concurrent medication use.&#x0D; ApproachWe conducted a cohort study of patients aged ≥65 years from Manitoba, Canada, with incident hypertension diagnosed in 2004 and followed to 2009. We calculated adherence rates to anti-hypertensive medications using different operational definitions of medication adherence (including interval and prescription based medication possession ratios [MPR] and proportion of days covered [PDC]). For those on concurrent medications, we calculated adherence rates using the different methods of handling concurrent medication use, for each definition. We used logistic regression to determine the association between adherence and mortality for each operational definition.&#x0D; ResultsAmong 2199 patients, 24.1% to 90.5% and 71.2% to 92.7% were considered adherent when using fixed interval and prescription-based interval medication possession ratios [MPRi and MPRp] respectively, depending on how concurrent medications were handled. Adherence was inversely associated with death, with the strongest association for MPRp measures. This association was significant only when considering adherence to any hypertensive [aOR 0.70, 95% CI 0.51, 0.97], or when the mean of the class-specific MPRp’s [adjusted OR 0.71, 95% CI 0.53, 0.95] was used. No significant association existed when the highest or lowest class-specific MPRp was used as the adherence estimate.&#x0D; ConclusionThe range of adherence estimates varies widely depending on the operational definition used. Given less variation in adherence rates and their stronger association against mortality, we recommend using prescription-based MPR’s to define medication adherence.

Anthropometrically Determined Undernutrition among the Adolescent Girls in Kathmandu Valley.

Background No information exists regarding the health of the adolescent girls residing in Kathmandu valley in urban setup. Objective To evaluate the prevalence of undernutrition among the adolescent girls living in Kathmandu valley. It also aims to know the distribution of weight, height and body mass index of adolescent girls in relation to the different adolescent age groups. Method A cross sectional study was conducted in one government and two private schools in Kathmandu valley from 16th April to 15th September 2010. Anthropometric measurements were recorded using standardized methodology as recommended by World Health Organization (WHO). Standard operational definitions like percentiles, mean, standard deviation and proportions were used for analysis. Result Four hundred adolescent girls were enrolled randomly, out of which 111 girls (27.8%) were from government school and 289 girls (72.2 %) were from private schools. Maximum were of 16 years of age and the least were of 19 years of age, mean age being 15.4 years of age. Of them, early, mid and late adolescents were 41%, 35% and 24% respectively. Around one third of the study population were stunted (32%), one fourth were underweight (24%) and one tenth of them were thin (9.5%) based on National Center for Health Statistics (NCHS )standard. Both underweight and stunted girls were significantly more during the late adolescence period (P<0.001). However, thinness was not significant in any of the three adolescent age groups. Conclusion A high prevalence of undernutrition in terms of stunting, underweight and thinness exists among the adolescent girls in Kathmandu valley.