Individual Item Scores Research Articles

The relationship between health-related quality of life (HRQoL) and clinical outcomes in patients with advanced renal cell carcinoma (aRCC) in CheckMate (CM) 214.

4502 Background: In CM 214, when compared to sunitinib (S), nivolumab plus ipilimumab (N+I) was associated with both clinical benefit and improved HRQoL as first-line treatment for intermediate/poor (I/P)-risk patients (pts). This analysis investigates the direct association between HRQoL and clinical outcomes in aRCC pts. Methods: I/P-risk population included 425 and 422 pts in the N+I and S arms, respectively. HRQoL was assessed using the FKSI-19 (Total Score and Disease Related Symptoms [DRS]). Three separate analyses (A, B, and C) were conducted. A: Changes in individual item scores from baseline to last assessment prior to progression were descriptively assessed. B: For each FKSI-19 score, multivariable Cox regression, adjusted for treatment and stratification factors, was used to evaluate the prognostic significance of baseline and time-dependent HRQoL scores in separate models. Hazard ratios (HR) were calculated based on the risk of death per improvement in HRQoL scores, defined using the clinically meaningful change threshold (5 points for FKSI-19 Total and 3 points for DRS). Pts with overall survival (OS) events were censored if their survival event was not within 12 weeks of the last available HRQoL assessment. C: The association between HRQoL change status (ie, improvement or maintenance vs. worsening from baseline in the FKSI-19 Total Score), irrespective of treatment arm, and OS was further assessed using a landmark analysis at the month 6 (mo-6) landmark. Additional landmark time points were explored in sensitivity analysis. Results: Items related to fatigue and perceived bother of the side-effects of treatment had the largest percentage of pts worsening prior to progression. In both baseline and time-dependent HRQoL analyses, OS was independently associated with both HRQoL measures. Higher (better) baseline scores were associated with significantly reduced risk of death (HR [95% CI] for FKSI-19 Total Score and DRS was 0.83 [0.80-0.87] and 0.80 [0.76-0.84], respectively). Every 5-point increase (improvement) in FKSI-19 Total Score and 3-point increase in DRS was associated with a 31% decreased risk of death ( P < 0.01). At mo-6, 301 pts showed improvement or maintenance in HRQoL. Pts with improved/stable HRQoL had a 52% reduction in risk of death compared to pts who had worsened (HR 0.48 [95% CI: 0.39-0.59]). Conclusions: Results demonstrate there is an association between HRQoL and clinical outcomes in CM 214. Baseline HRQoL scores are a potential predictor for survival in aRCC, and HRQoL changes are informative for pts’ expected survival. HRQoL change status at mo-6 was significantly and positively associated with subsequent survival. Thus, patient-reported outcomes may be useful for both describing pt experience in clinical trials and providing valuable clinical insights during routine practice. Clinical trial information: NCT02231749.

Simplified Histologic Mucosal Healing Scheme (SHMHS) for inflammatory bowel disease: a nationwide multicenter study of performance and applicability

BackgroundAssessment of mucosal healing is important for the management of patients with inflammatory bowel disease (IBD), but endoscopy can miss microscopic disease areas that may relapse. Histological assessment is informative, but no single scoring system is widely adopted. We previously proposed an eight-item histological scheme for the easy, fast reporting of disease activity in the intestine. The aim of the present study was to evaluate the performance of our Simplified Histologic Mucosal Healing Scheme (SHMHS).MethodsBetween April and May 2021 pathologists and gastroenterologists in Italy were invited to contribute to this multicenter study by providing data on single endoscopic–histological examinations for their IBD patients undergoing treatment. Disease activity was expressed using SHMHS (maximum score, 8) and either Simple Endoscopic Score for Crohn’s Disease (categorized into grades 0–3) or Mayo Endoscopic Subscore (range 0–3).ResultsThirty hospitals provided data on 597 patients (291 Crohn’s disease; 306 ulcerative colitis). The mean SHMHS score was 2.96 (SD = 2.42) and 66.8% of cases had active disease (score ≥ 2). The mean endoscopic score was 1.23 (SD = 1.05), with 67.8% having active disease (score ≥ 1). Histologic and endoscopic scores correlated (Spearman’s ρ = 0.76), and scores for individual SHMHS items associated directly with endoscopic scores (chi-square p < 0.001, all comparisons). Between IBD types, scores for SHMHS items reflected differences in presentation, with cryptitis more common and erosions/ulcerations less common in Crohn’s disease, and the distal colon more affected in ulcerative colitis.ConclusionsSHMHS captures the main histological features of IBD. Routine adoption may simplify pathologist workload while ensuring accurate reporting for clinical decision making.

Safety Climate in the Indonesian Construction Industry: Strengths, Weaknesses, and Influential Demographic Characteristics

The Indonesian construction industry is a significant contributor to economic growth in Indonesia. However, poor safety performance limits its contributions due to the negative impacts of poor safety on project performance. This research aims to assess the level of the safety climate in the Indonesian construction industry, identify its strengths and weaknesses, and understand the influence of individual demographic characteristics on the safety climate. Data were collected using a questionnaire survey from 1757 respondents working in six large state-owned construction companies in Indonesia. Results indicate that the overall safety climate level is fairly good. However, the safety climate scores of individual safety climate items are observed to vary widely. The scores reveal that construction employees understand the importance of safety and management demonstrates a degree of safety commitment, particularly by having regular safety communications. In contrast, the implementation of safety is limited in reality because safety is not considered a priority at work. Lack of safety resources and limited enforcement of safety rules further hinder the implementation of safety at the project level. Large state-owned construction companies such as those where data were collected should take the lead in changing the work practices in the Indonesian construction industry to improve safety performance. Level of education, length of work experience, position, permanency of job status, work location (project or office-based), and type of project are individual demographic characteristics that influence the level of the safety climate. Understanding the influence of these characteristics on the safety climate allows specific intervention strategies to be used to improve safety.

Alternative scoring of the Patient Health Questionnaire-9 in neurological populations: an approach based on a predictive algorithm deriving from individual item scores

ObjectiveThe study objective was to assess whether machine learning methods could improve predictive performance of the PHQ-9 for depression in patients with neurological disease. Specifically, we assessed whether a predictive algorithm deriving from all nine items could outperform the tradition of summing the items and applying a cut-point. MethodData from the NEEDS Study was used (n = 825). Demographic data, PHQ-9 scores, and MDD diagnoses (via the SCID) were obtained. Logistic LASSO, logistic regression, and non-parametric ROC analyses were performed. The ROC curve was used to identify the optimal cut-point for regression-derived predictive algorithms using the Youden method. ResultsThe traditional approach to PHQ-9 scoring had a classification accuracy of 85.1% (sensitivity: 84.5%; specificity: 85.2%). The logistic LASSO regression model had a classification accuracy of 85.6% (sensitivity: 83.3%; specificity: 86.1%). The logistic regression model had a classification accuracy of 85.8% (sensitivity: 91.4%; specificity: 84.8%). Both models had similar areas under the curve values (logistic LASSO: 0.9097; logistic regression: 0.9026). ConclusionsThe current cut-off threshold approach to PHQ-9 scoring and interpretation remains clinically appropriate.

Durability of the Clinical Benefit of Droxidopa for Neurogenic Orthostatic Hypotension During 12 Weeks of Open-Label Treatment.

IntroductionDroxidopa is approved to treat neurogenic orthostatic hypotension (nOH) symptoms in patients with autonomic failure based on short-term clinical trial data. Additional data on the long-term efficacy of droxidopa are needed. We have evaluated the 12-week efficacy and tolerability of droxidopa in patients with nOH in an open-label period of an ongoing phase 4 study .MethodsPatients received 12 weeks of open-label treatment with an individually optimized droxidopa dose (100–600 mg, 3 times daily) as identified during a preceding titration period. Patient-reported outcomes included the Orthostatic Hypotension Symptom Assessment (OHSA), Orthostatic Hypotension Daily Activity Scale (OHDAS), and clinician- and patient-rated Clinical Global Impression–Severity (CGI-S) scales. Supine blood pressure (BP) and adverse events (AEs) were recorded.ResultsData from 114 patients enrolled into the 12-week open-label period were available for analyses. After 12 weeks of droxidopa treatment, patients reported significant (P < 0.0001) improvements from baseline in OHSA and OHDAS composite and individual item scores and on clinician and patient CGI-S scores. Mean ± SD supine systolic and diastolic BP at week 12 increased by 15.5 ± 22.9 and 7.8 ± 11.7 mmHg from baseline, respectively (P < 0.0001 for both). The most frequently reported AEs were falls (17%), headache (13%), and dizziness (9%); one (0.9%) patient reported an AE of supine hypertension.ConclusionDuring 12 weeks of open-label treatment, droxidopa was associated with significant improvement from baseline in nOH symptoms and activities of daily living. No clinically important changes in supine hypertension or AEs of concern were observed. These results support the efficacy of droxidopa beyond 2 weeks of treatment. Trial RegistrationNCT02586623.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40120-021-00317-5.

Living Kidney Donor Knowledge of Provided Information and Informed Consent: The PRINCE Study.

Background: Informed consent for living kidney donation is paramount, as donors are healthy individuals undergoing surgery for the benefit of others. The informed consent process for living kidney donors is heterogenous, and the question concerns how well they are actually informed. Knowledge assessments, before and after donor education, can form the basis for a standardized informed consent procedure for live kidney donation. Methods: In this prospective, a multicenter national cohort study conducted in all eight kidney transplant centers in The Netherlands, we assessed the current status of the informed consent practice for live donor nephrectomy. All of the potential living kidney donors in the participating centers were invited to participate. They completed a pop quiz during their first outpatient appointment (Cohort A). Living kidney donors completed the same pop quiz upon admission for donor nephrectomy (Cohort B). Results: In total, 656 pop quizzes were completed (417 in Cohort A, and 239 in Cohort B). The average donor knowledge score was 7.0/25.0 (±3.9, range 0–18) in Cohort A, and 10.5/25.0 (±2.8, range 0–17.5) in Cohort B. Cohort B scored significantly higher on overall knowledge, preparedness, and the individual item scores (p < 0.0001), except for the long-term complications (p = 0.91). Conclusions: Donor knowledge generally improves during the live donor workup, but it is still quite disappointing. Long-term complications, especially, deserve more attention during living kidney donor education.

Prevalence of Nomophobia and an Analysis of Its Contributing Factors in the Undergraduate Students of Pakistan.

Nomophobia (no-mobile-phone phobia) is a relatively new term that describes the growing fear and anxiety associated with being without a mobile phone. Our study aims to determine the prevalence of nomophobia among the undergraduate students of Pakistan, and to determine its correlation with age and gender. It also aims to determine the contributory factors of nomophobia. A cross-sectional study was conducted through an online survey from March 25 to April 25, 2021. The snowball sampling technique was used for data collection. The Nomophobia Questionnaire (NMP-Q) developed by Yildirim and Correia was circulated among the target population. It was a 7-point Likert Scale that was analyzed on the basis of age and gender using IBM SPSS version 22 and MS Excel 2007. The contributing factors were also analyzed. Of the 483 responses we received, 28 were discarded due to incompleteness and respondents being out of age under study that is, 15-25 years. Most of the respondents were women (n = 314, 69.01 percent). Men were less in number than women (n = 141, 31 percent). The ages of most of the respondents lied between 15 and 25 years. Twenty was the mode age. One hundred eighty-six (40.88 percent) had severe, 221 (48.57 percent) had moderate, and 48 (10.55 percent) had mild nomophobia. Average factor-wise scores and individual item scores were also added. Our findings reached a conclusion that the majority of the undergraduate students in Pakistan suffer from nomophobia ranging from its mild to severe form. Nomophobia can possibly be included as a recognized phobia in the DSM. Wider research on the subject to investigate it further and evaluate the clinical significance should be done.

Change in individual chronic obstructive pulmonary disease assessment test item scores after short-term bronchodilator therapy and its impact on exacerbation in treatment-naïve patients with chronic obstructive pulmonary disease.

Background:The chronic obstructive pulmonary disease (COPD) assessment test (CAT) measures the health status of patients with COPD. We aimed to investigate the change in individual CAT scores after short-term bronchodilator therapy among treatment-naïve patients with COPD.Methods:Data from 148 patients newly diagnosed with COPD between January 2016 and April 2020 were retrospectively analyzed. We compared the CAT score, modified Medical Research Council (mMRC) dyspnea grade, and forced expiratory volume in 1 s (FEV1) before and after short-term (6 ± 2 months) bronchodilator therapy. We analyzed the change trends using generalized estimating equations.Results:The mean patient age was 70.9 years, and 92.6% were male. The total CAT score did not significantly improve. However, among the CAT items, phlegm [adjusted difference: –0.22 (–0.48, –0.002)], chest tightness [–0.30 (–0.56, –0.05)], and breathlessness [–0.45 (–0.66, –0.23)] scores significantly improved after bronchodilator therapy. The patients were divided into two groups: CAT score improved (n = 69) and not improved group (n = 79). The development of moderate-to-severe exacerbations during follow-up was significantly lower (2.9% versus 17.7%, p = 0.004) in the CAT score improved group.Conclusion:The improvement in CAT items indicating respiratory symptoms was more evident than the CAT total score after short-term bronchodilator therapy. Despite the significant increase in FEV1 after bronchodilator therapy, fewer than half of the patients achieved meaningful improvement in CAT, and this group showed significantly lower development of exacerbation during follow-up.

Delphi consensus on the American Society of Anesthesiologists’ physical status classification in an Asian tertiary women’s hospital

BackgroundThe American Society of Anesthesiologists (ASA) score is generated based on patients’ clinical status. Accurate ASA classification is essential for the communication of perioperative risks and resource planning. Literature suggests that ASA classification can be automated for consistency and time-efficiency. To develop a rule-based algorithm for automated ASA classification, this study seeks to establish consensus in ASA classification for clinical conditions encountered at a tertiary women’s hospital.MethodsThirty-seven anesthesia providers rated their agreement on a 4-point Likert scale to ASA scores assigned to items via the Delphi technique. After Round 1, the group’s collective responses and individual item scores were shared with participants to improve their responses for Round 2. For each item, the percentage agreement (‘agree’ and ‘strongly agree’ responses combined), median (interquartile range/IQR), and SD were calculated. Consensus for each item was defined as a percentage agreement ≥ 70%, IQR ≤ 1.0, and SD < 1.0.ResultsAll participants completed the study and none had missing data. The number of items that reached consensus increased from 25 (51.0%) to 37 (75.5%) in the second Delphi round, particularly for items assigned ASA scores of III and IV. Nine items, which pertained to alcohol intake, asthma, thyroid disease, limited exercise tolerance, and stable angina, did not reach consensus even after two Delphi rounds.ConclusionsDelphi consensus was attained for 37 of the 49 study items (75.5%), facilitating their incorporation into a rule-based clinical support system designed to automate the prediction of ASA classification.

Mapping the Food Allergy Quality of Life Questionnaire Parent Form onto the Short‐Form Six‐Dimensions version 2

The Food Allergy Quality of Life Questionnaire Parent Form (FAQLQ-PF) is the most widely used quality of life questionnaire in food allergy. The objective of this study was to develop a mapping algorithm to convert FAQLQ-PF scores into health state utilities. The Short-Form Six-Dimensions version 2 (SF-6Dv2) and FAQLQ-PF questionnaires were collected from an academic center oral immunotherapy referral cohort. Utility estimates were derived from the SF-6Dv2 using the food allergy preference set. Candidate mapping algorithm models were developed using seven regression methods starting from either the total average score, the average scores of each of the three domains or the individual item scores of FAQLQ-PF. The process was repeated twice, including only section A, common to all age groups, or including all age-applicable sections of the FAQLQ-PF. The mean absolute error (MAE) and root mean squared error (RMSE) were used to select the best fitting model. An independent cohort from a previous national online survey was used for external validation. In the index cohort, 1000 of 1257 respondents had completed both questionnaires. The lowest MAE (0.0791) and RMSE (0.1020) were recorded when entering individual item scores in a categorical regression model. The model including only FAQLQ-PF section A was found to be most consistent when tested in the external validation cohort (n=248) (MAE of 0.0898). The FAQLQ-PF was mapped onto SF-6Dv2 utilities with good predictive accuracy in two independent cohorts. This will enable calculation of health utility for cost-effectiveness analyses in food allergy.

The Relationship between Landing Error Scoring System Performance and Injury in Female Collegiate Athletes.

BackgroundThe Landing Error Scoring System (LESS) is a standardized tool used to identify aberrant biomechanical movement patterns during a jump-landing task. Prior authors have examined the value of the LESS in identifying ACL injury risk in athletic populations. Yet, no study has evaluated the association between LESS performance and incidence of any type of lower extremity injury in female collegiate athletes across multiple sports.PurposeThe purpose of this study was to examine the association between LESS performance as measured with a markerless motion-capture system and lower extremity injury in female collegiate athletes.Study DesignProspective cohort study.MethodsOne hundred and ten DI female collegiate athletes (basketball, n=12; field hockey, n=17; gymnastics, n=14; lacrosse, n=27; softball, n=23; volleyball, n=17) completed a jump-landing test prior to the start of their sport seasons. The LESS was automatically scored using a Microsoft Kinect sensor and Athletic Movement Assessment software (PhysiMax®). Participants were tracked throughout one competitive season for incidence of time-loss lower extremity injury. A Receiver Operating Characteristic curve determined the optimal cutpoint for the total LESS score for predicting injury. Pearson’s Chi squared statistics examined the association between injury and LESS total scores >5. The Fisher exact test evaluated group differences for the frequency of receiving an error on individual LESS test items.ResultsFemale collegiate athletes with LESS scores >5 were not more likely to be injured than those with scores ≤5 (χ2=2.53, p=0.111). The relative risk of injury to this group was 1.78 (95% CI=0.86, 3.68) while the odds ratio was 2.10 (95% CI=0.83, 5.27). The uninjured group was more likely to receive an error on lateral trunk flexion at initial contact than the injured group (p=0.023).ConclusionThe LESS total score was not associated with an increased odds of lower extremity injury in this cohort of female collegiate athletes. Future studies to examine the association between individual LESS item scores and injury are warranted.Level of Evidence1b.

Utility of the Intelligibility in Context Scale for Predicting Speech Intelligibility of Children with Cerebral Palsy.

The Intelligibility in Context Scale (ICS) is a widely used, efficient tool for describing a child’s speech intelligibility. Few studies have explored the relationship between ICS scores and transcription intelligibility scores, which are the gold standard for clinical measurement. This study examined how well ICS composite scores predicted transcription intelligibility scores among children with cerebral palsy (CP), how well individual questions from the ICS differentially predicted transcription intelligibility scores, and how well the ICS composite scores differentiated between children with and without speech motor impairment. Parents of 48 children with CP, who were approximately 13 years of age, completed the ICS. Ninety-six adult naïve listeners provided orthographic transcriptions of children’s speech. Transcription intelligibility scores were regressed on ICS composite scores and individual item scores. Dysarthria status was regressed on ICS composite scores. Results indicated that ICS composite scores were moderately strong predictors of transcription intelligibility scores. One individual ICS item differentially predicted transcription intelligibility scores, and dysarthria severity influenced how well ICS composite scores differentiated between children with and without speech motor impairment. Findings suggest that the ICS has potential clinical utility for children with CP, especially when used with other objective measures of speech intelligibility.

Construct validity and internal consistency of the Breast Inflammatory Symptom Severity Index in lactating mothers with inflammatory breast conditions.

BackgroundInflammatory Conditions of the Lactating Breast (ICLB) affect more than one in five lactating mothers, yet no fully validated outcome measures exist to aid clinicians in their patient-centred care of women with ICLB. The Breast Inflammatory Symptom Severity Index (BISSI) is an ICLB-specific clinician administered patient-reported outcome measure, currently used by Australian clinicians, who treat mothers with ICLB. To date the BISSI has undergone partial psychometric development. This study, therefore, aimed to undertake the next stage of psychometric development by determining the construct validity and internal consistency of the BISSI.MethodsA retrospective audit was conducted on patient records of 160 mothers who were treated for ICLB, at a private physiotherapy practice in Melbourne, Australia. An electronic data capture tool was used to collate BISSI scores and associated ICLB assessment variables. Construct validity was determined through factor analysis and discriminant performance. Reliability was determined by assessing measures of internal consistency.ResultsFactor analysis established that BISSI items (n = 10) loaded on to four factors, Wellness, Pain, Physical Characteristics of Affected Area (PCAA), and Inflammation, which together, explained 71.2% of variance. The remaining item (‘Wellness/sickness unspecified’) did not load. Wellness, Pain, PCAA and Inflammation factors individually and collectively displayed the ability to discriminate symptom severity, as scores were significantly higher in mothers with high symptom severity (assessed via AUC close to or >0.7 and P value <0.005 for each factor). The BISSI demonstrated internal consistency with an overall Cronbach alpha of 0.742.ConclusionsThe BISSI has adequate construct validity, demonstrating behaviour consistent with theoretical constructs of inflammation severity, via its dimensionality and ability to discriminate symptom severity. The BISSI also has adequate internal consistency demonstrating reliability. Therefore, clinicians can have confidence that the BISSI is valid, the individual item scores are correlated, and the concepts are consistently measured.

Critical Appraisal of Paralyzed Veterans of America Guidelines in Spinal Cord Injury: An International Collaborative Study Using the Appraisal of Guidelines for Research and Evaluation II Instrument (AGREE II).

Spinal cord injuries (SCI) in military personnel, veterans, and others require an evidence-based, multidisciplinary approach to their care. This appraisal used the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument to evaluate the methodological quality of clinical guidelines for the management of SCI published by the Paralyzed Veterans of America (PVA) organization. We searched clinical guidelines on SCI published by PVA until December 2019. Four appraisers across three international centers independently evaluated the quality of eligible clinical guidelines using AGREE II. Mean AGREE II scores for each domain were calculated. In higher quality domains, scores for individual items were analyzed. A total of 12 guidelines published by PVA on SCI were assessed. Mean scores for all six domains were as follows: Scope and Purpose (78.8%), Stakeholder Involvement (63.7%), Rigor of Development (68.4%), Clarity of Presentation (80.1%), Applicability (53.0%), and Editorial Independence (28.5%). The mean score for the overall quality of all PVA guidelines was 71.9% (95% CI: 69.7-74.1). No guideline was assessed as "not recommended" by any appraiser. Overall quality was significantly associated with year of publication (rs = 0.754, P = 0.0046). Overall agreement among appraisers was excellent (intraclass correlation coefficients for each guideline ranged from 0.96 to 0.99). PVA guidelines for the management of SCI demonstrated acceptable or good quality across most domains. We recommend the use of PVA guidelines for the assessment and treatment of SCI and related disorders. The quality of PVA guidelines for the management of SCI have improved over time.

Comparison of three kinds of free flaps used in patients with oral and oropharyngeal tumors

Objective: To compare the recovery and quality of life of patients with oral and oropharyngeal tumors treated with three kinds of free soft tissue flaps. Methods: The clinical data of 103 patients, including 66 males and 37 females, aged 26-74 years, who underwent primary repair of defects after resection of oral and oropharyngeal tumors in Sichuan Tumor Hospital from July 2014 to August 2020 were analyzed. Anterolateral thigh flap (ALTF) was used in 43 patients, radial forearm free flap (RFFF) in 45 patients, and lateral arm free flap (LAFF) in 15 patients. Postoperative qualities of life of patients were evaluated by the university of Washington quality of life questionnaire and oral health impact scale (HIP-14 Chinese edition). SPSS 23.0 software was used for statistical analysis. Results: The T staging of RFFF or LAFF group was significantly lower than that of ALTF group (P<0.05). There was no significant difference in mean flap areas between ALTF group ((55.87±27.38) cm2) and LAFF group ((49.93±19.44) cm2), while RFFF group had smaller mean flap area ((33.18±6.05) cm2) than ALTF group (t=5.311, P<0.001) and LAFF group (t=3.284, P=0.005). In terms of oral functions including swallowing, mastication, taste and spitmouth, there were no significant differences between LAFF group and RFFF group (P>0.05), but both groups had better oral functions than ALTF group (P<0.05). There was no significant difference in appearance scores between LAFF group (75(75, 75)) and ALTF group (75(75,75) vs.75(75,75),Z=-1.532, P=0.126), and both groups had higher scores than RFFF group (50(50, 75),Z values were -3.447 and -3.005 respectively, P<0.05). RFFF group had higher speech score (100(67, 100)) than LAFF group (67(50, 76),Z=-2.480, P<0.05) and ALTF group (67(33, 67),Z=-5.414, P<0.05). ALTF group had lower mean score of quality of life than RFFF group [72(56,77) vs.79(69, 89),Z=-3.070, P<0.05), but there was no statistical difference in the mean scores of qualities of life between ALTF group and LAFF group (Z=1.754, P=0.079). According to the evaluation of oral health impact scale (HIP-14 Chinese version) 1 year after surgery, individual item scores and the average score of all items in ALTF group were lower than those in RFFF and LAFF groups (P<0.05), with no significant difference between RFFF group and LAFF group (P>0.05). Conclusions: RFFF has unique advantages for small tissue defects, while ALTF is suitable for large tissue defects, such as buccal penetrating defect, whole tongue and near whole tongue defect, and LAFF is a compromise choice between ALTF and RFFF. ALTF is inferior to RFFF and LAFF in oral functional reconstruction, including swallowing, chewing, taste and spittle. ALTF and LAFF are superior to RFFF in postoperative appearance.

The application of AMSTAR2 in 32 overviews of systematic reviews of interventions for mental and behavioural disorders: A cross-sectional study.

'A measurement tool to assess systematic reviews, version 2' (AMSTAR2) is a 16-item tool to critically appraise systematic reviews (SRs) of healthcare interventions. This study aimed to assess the methods and outcomes of AMSTAR2 appraisals in overviews of SRs of interventions for mental and behavioural disorders. The cross-sectional study was conducted using 32 overviews of SRs selected from three electronic databases in January 2021. Data items included overview and SR characteristics and AMSTAR2 appraisal methods and outcomes. Data were extracted by two authors independently and narratively synthesised using descriptive statistics (means ± SD and relative frequencies). SR characteristics were compared based on AMSTAR2 appraisal outcomes using chi-square tests. The 32 overviews appraised SRs of predominantly non-pharmacological interventions for mental disorders. AMSTAR2 appraisals were reported as confidence ratings in 25/32 overviews or individual item scores in 24/32 overviews. Most SRs/overview were non-Cochrane (mean=94%), included RCTs only (mean=77%) and were published before AMSTAR2 release (mean=79%). The confidence ratings derived in 25 overviews for 349 SRs were predominantly critically low (68%). Confidence ratings were similar for SRs with RCTs only versus RCTs+non-RCTs or SRs published before versus after AMSTAR2 release, while Cochrane SRs received more high+moderate than low+critically low confidence ratings (p < 0.01). Confidence ratings derived based on AMSTAR2 do not differentiate among SRs of healthcare interventions except for Cochrane SRs that fulfil the criteria for high confidence ratings. AMSTAR2 items should be consulted to avoid common weaknesses in future SRs.

Quality of life in young adults with acne: Results of a cross-sectional study.

The impact of acne on quality of life (QoL) may vary between patients from different age groups. There are limited data in the literature on QoL of young adults with acne and acne scars. To assess the QoL of young adults (age 18 to 25) with acne by using dermatology life quality index (DLQI) and Cardiff acne disability index (CADI), to assess the scores of individual items on DLQI and CADI, and to compare the two scales. In this cross-sectional questionnaire study of 1392 subjects with acne, each subject completed two questionnaires: DLQI and CADI. Mean values of DLQI and CADI, and those of individual items on DLQI and CADI were calculated; t-test was used for testing mean values and Spearman's rho coefficient for correlation between two questionnaires. Mean DLQI (4.50) and CADI (3.60) scores were low. However, scores were significantly higher in females and in those with acne scars. "Feelings of embarrassment" and "interference with social activities" scored significantly higher for females across both questionnaires. There was no correlation between severity (as well as duration) of acne and HRQoL scores. Spearman's rho coefficient of correlation between DLQI and CADI was 0.71. Acne impaired the QoL of young adults, acne scars more so. Females felt worse about their appearance with greater embarrassment and impaired social activities. QoL scores seem to depend on patients' perceptions, which may depend on factors other than objective severity of acne. We found good correlation between the two scales.

Assessing Cannabis Use Disorder in Medical Cannabis Patients: Interim Analyses from an Observational, Longitudinal Study.

To date, no studies have directly assessed potential cannabis use disorder (CUD) in medical cannabis (MC) patients pre- vs post-MC treatment. Given that MC patients use cannabis for symptom alleviation rather than intoxication, we hypothesized that MC patients would exhibit few symptoms of CUD after initiating MC treatment. As part of an ongoing observational, longitudinal study, 54 MC patients completed baseline assessments prior to initiating MC use and returned for at least one follow-up assessment after three, six, and/or twelve months of a self-selected MC treatment regimen; detailed MC treatment information was collected and quantified. All patients completed the Cannabis Use Disorder Identification Test - Revised (CUDIT-R) at each visit. Changes in individual items scores and total scores were assessed over time, and we examined whether total CUDIT-R scores correlated with frequency of MC use, delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) exposure. Further, Cronbach's alpha analyses were conducted to provide preliminary data regarding the psychometric properties of the CUDIT-R when used among MC patients. Although total CUDIT-R scores increased relative to baseline, on average, ratings fell below the 'hazardous use' threshold at each visit. Analyses of individual items revealed that increases in total scores were primarily attributable to increases in frequency of use and not necessarily other aspects of problematic use. Total CUDIT-R scores were not associated with number of MC uses or CBD exposure, but a significant relationship was detected between increased THC exposure and higher CUDIT-R scores. Importantly however, analyses revealed that the CUDIT-R does not appear to be an appropriate tool for identifying CUD in MC patients. Screening tools specifically designed to assess CUD in MC patients are needed and should distinguish between frequent use and problematic use; exposure to individual cannabinoids must also be considered.

OS05.4.A Do neurocognitive deficits explain the differences between brain tumour patients and their proxies assessing the patient’s I-ADL?

Abstract BACKGROUND Neurocognitive deficits are common among brain tumour patients, and may impact on patient awareness of deficits in instrumental activities in daily life (IADL). This study aimed to examine differences between patient-reported and proxy-reported assessments of the patient’s performance of IADL, and whether the level of (dis)agreement is associated with neurocognitive deficits. MATERIAL AND METHODS A phase III EORTC questionnaire measuring IADL in brain tumour patients (EORTC IADL-BN32) and six neurocognitive test measures were administered as part of a larger multicentre international study designed to develop a brain tumour specific IADL questionnaire. Bland-Altman plots and Mann-Whitney U tests were used to evaluated patient- and proxy-reported IADL on a group level. Subsequently, Mann-Whitney U tests were performed to compare patient-proxy difference scores (patient IADL score - their proxy IADL score) between patients who were considered clearly neurocognitively impaired (≥2 neurocognitive test measures; ≤2.0 SD below healthy controls) and patients who were not. Furthermore, multinomial logistic regression analyses were performed to examined which sociodemgraphic, clinical, and particularly neurocognitive variables were independently associated with patients and proxies differing in their evaluation of patient’s IADL. RESULTS Patients (N=81) and proxies (N=81), on group level, did not significantly differ on either the IADL individual item or scale scores. However, significant differences were found on patient-proxy difference scores between patients who were (N=37) and were not (N=44) considered clearly neurocognitively impaired for 10/32 individual items and one of the scales (i.e. Scale 4: Administrative tasks), all showing that the proxies of clearly neurocognitively impaired patients reported more problems relative to the patients themselves, compared to proxies of patients not clearly neurocognitively impaired. Furthermore, for each scale, a neurocognitive variable, either impaired information processing speed, cognitive flexibility, verbal fluency or the number of neurocognitive test measures impaired, was found to be independently associated with proxies reporting more problems. For 4/5 scales, a clinical variable was additionally independently associated with proxies reporting more problems. Only one variable was independently associated with patient reporting more problems, namely being in active treatment was found to be associated with patients reporting more problems on Scale 4: Administrative tasks. CONCLUSION Results imply a consistent trend of clearly neurocognitively impaired patients underreporting problems with IADL compared to their proxies. It would therefore be advised to administer both the patient- and proxy-version of the EORTC IADL-BN32, particularly if neurocognitive deficits are presumed.

Patient Safety Culture or Embracing Low Intervention Evidence‐Based Care to Support Vaginal Birth: Where Should Hospitals Start?

Research ObjectiveApplying safety culture concepts – effective teamwork, psychological safety, engaged leadership, vigilance, and error reporting ‐ to the prevention of medical errors has seen broad support to reduce catastrophic outcomes (i.e., maternal mortality, hemorrhage, eclampsia, etc); however, their role in efforts to minimize overuse is less clear. This study aimed to evaluate safety culture on maternity units in relation to cesarean overuse, and examine whether it is independent of vaginal birth culture, which emphasizes evidence‐based low intervention care.Study Design6 Likert‐style items measuring safety culture themes were developed based on previous qualitative interviews of nurse and physician maternity unit clinical leads and were appended to the validated Labor Culture Survey (LCS). Within the LCS, the vaginal birth unit microculture (VBM) scale consists of 8 Likert‐style items assessing unit norms around supporting vaginal birth. Birth certificate data and hospital characteristics were linked with hospitals and respondents' survey responses. Multivariate Poisson regression analyses were adjusted for hospital demographics and clinical risk profiles.Population StudiedNurses, midwives, and physicians providing intrapartum care at hospitals in Michigan participating in quality improvement efforts to reduce cesarean overuse.Principal Findings3011 clinicians from 54 out of 57 participating hospitals completed the survey with a minimum unit response rate of 30% per hospital. Safety culture individual item scores showed significant association (p &lt; 0.05) with cesarean delivery rates after adjustment for hospital demographics and clinical risk. Specifically, as agreement increased on the following safety culture items, cesarean delivery rate decreased: a) frequent treatment team communication to discuss supporting vaginal; b) team members have equal input in management decisions; c) team members feel safe and encouraged to speak up if a patient's chance of having a vaginal birth may be negatively affected by management decisions; d) hospital leadership is engaged in making change to support vaginal birth; e) individual feels personally responsible to maximize the patient's chance of having vaginal birth; and f) nurses feel encouraged to play an active role in making patient management decisions. A safety culture composite score demonstrated a strong association with reduction in cesarean rate by hospital [−16% (95% CI ‐0.30 to −0.03)], parallel to but lower in magnitude to VBM [−30% (95% CI ‐0.48 to −0.13)]. No significant interaction effect between mean VBM and safety culture of a hospital was found (p = 0.79), suggesting that the effect of VBM versus safety culture on the hospital cesarean delivery rate are independent.ConclusionsVaginal birth microculture remains the strongest predictor of cesarean delivery overuse; however, safety culture characteristics including teamwork, psychological safety, and communication demonstrate a strong association with lower cesarean delivery rates, which appear to be similarly important, and independent of vaginal birth culture.Implications for Policy or PracticeHospitals addressing cesarean overuse should prioritize readiness for both the specific norms and behaviors of promoting vaginal birth and promoting a broader culture of safety. Measuring both aspects of hospitals' culture during quality improvement efforts may provide insight into organizations with high patient safety profiles that still struggle with high cesarean delivery rates.Primary Funding SourceSupport for the Obstetrics Initiative is provided by Blue Cross Blue Shield of Michigan and Blue Care Network as part of the BCBSM Value Partnerships program.