Adaptive designs were primarily used but inadequately reported in early phase drug trials.

BACKGROUND: Faced with the high cost and limited efficiency of classical randomized controlled trials, researchers are increasingly applying adaptive designs to speed up the development of new drugs. However, the application of adaptive design to drug randomized controlled trials (RCTs) and whether the reporting is adequate are unclear. Thus, this study aimed to summarize the epidemiological characteristics of the relevant trials and assess their reporting quality by the Adaptive designs CONSORT Extension (ACE) checklist. METHODS: We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and ClinicalTrials.gov from inception to January 2020. We included drug RCTs that explicitly claimed to be adaptive trials or used any type of adaptative design. We extracted the epidemiological characteristics of included studies to summarize their adaptive design application. We assessed the reporting quality of the trials by Adaptive designs CONSORT Extension (ACE) checklist. Univariable and multivariable linear regression models were used to the association of four prespecified factors with the quality of reporting. RESULTS: Our survey included 108 adaptive trials. We found that adaptive design has been increasingly applied over the years, and was commonly used in phase II trials (n = 45, 41.7%). The primary reasons for using adaptive design were to speed the trial and facilitate decision-making (n = 24, 22.2%), maximize the benefit of participants (n = 21, 19.4%), and reduce the total sample size (n = 15, 13.9%). Group sequential design (n = 63, 58.3%) was the most frequently applied method, followed by adaptive randomization design (n = 26, 24.1%), and adaptive dose-finding design (n = 24, 22.2%). The proportion of adherence to the ACE checklist of 26 topics ranged from 7.4 to 99.1%, with eight topics being adequately reported (i.e., level of adherence ≥ 80%), and eight others being poorly reported (i.e., level of adherence ≤ 30%). In addition, among the seven items specific for adaptive trials, three were poorly reported: accessibility to statistical analysis plan (n = 8, 7.4%), measures for confidentiality (n = 14, 13.0%), and assessments of similarity between interim stages (n = 25, 23.1%). The mean score of the ACE checklist was 13.9 (standard deviation [SD], 3.5) out of 26. According to our multivariable regression analysis, later published trials (estimated ß = 0.14, p < 0.01) and the multicenter trials (estimated ß = 2.22, p < 0.01) were associated with better reporting. CONCLUSION: Adaptive design has shown an increasing use over the years, and was primarily applied to early phase drug trials. However, the reporting quality of adaptive trials is suboptimal, and substantial efforts are needed to improve the reporting.

Guidelines in Practice: Team Communication.

The perioperative setting is a complex environment requiring interdisciplinary team collaboration to avoid adverse events. To protect the safety of patients and perioperative team members, communication among personnel should be clear and effective. The recently updated AORN "Guideline for team communication" provides perioperative nurses with recommendations on the topic. To promote effective communication in perioperative areas, all personnel should value and commit to a culture of safety. This article discusses recommendations for supporting a culture of safety, developing and implementing an effective hand-off process and surgical safety checklist, and developing education strategies for team communication. It also includes a scenario describing the implementation of a standardized, electronic surgical safety checklist in the OR. Perioperative nurses should review the guideline in its entirety and apply the recommendations for team communication in their working environments.

Improving Team Members' Attention During the OR Briefing or Time Out.

Effective coordination among health care professionals is crucial to achieving optimal outcomes. In the OR, even minor errors can have catastrophic consequences. To mitigate the risk of error, health care professionals have adopted a briefing culture like that used in the aviation industry. Briefings are essential to ensure that everyone involved in a procedure knows the plan and potential risks and is prepared to perform their duties safely and effectively. The fundamental human sense involved in briefings is auditory perception; although important, hearing alone does not equate to focused attention. To enhance the efficacy of briefings, engaging the use of a second sense by adding a visual checklist may increase attentiveness and the chances of early error detection and prevention. Using a projection device may enhance all team members' engagement and participation during the briefing or time-out process and can be an effective tool for improving communication and reducing errors.

What do meta-analysts need in primary studies? Guidelines and the SEMI checklist for facilitating cumulative knowledge.

Meta-analysis is often recognized as the highest level of evidence due to its notable advantages. Therefore, ensuring the precision of its findings is of utmost importance. Insufficient reporting in primary studies poses challenges for meta-analysts, hindering study identification, effect size estimation, and meta-regression analyses. This manuscript provides concise guidelines for the comprehensive reporting of qualitative and quantitative aspects in primary studies. Adhering to these guidelines may help researchers enhance the quality of their studies and increase their eligibility for inclusion in future research syntheses, thereby enhancing research synthesis quality. Recommendations include incorporating relevant terms in titles and abstracts to facilitate study retrieval and reporting sufficient data for effect size calculation. Additionally, a new checklist is introduced to help applied researchers thoroughly report various aspects of their studies.

The use of intrapartum ultrasound in operative vaginal birth: a retrospective cohort study.

BACKGROUND: Poor outcomes from operative vaginal birth have been associated with failure to recognize malposition, breakdown in interdisciplinary communication, and deviation from accepted guidelines. We recently implemented a safety bundle including routine intrapartum ultrasound and a structured time-out and procedural checklist aiming to reduce maternal and perinatal morbidity from operative vaginal birth. OBJECTIVE: This study aimed to compare births where intrapartum ultrasound was used and those where it was not used during a safety bundle implementation period at Monash Health. STUDY DESIGN: We performed a retrospective cohort study at Monash Health during the transitional phase of implementing an operative vaginal birth safety bundle. We studied all women with operative vaginal birth and fully dilated cesarean delivery with a singleton cephalic term fetus. We compared births for which intrapartum ultrasound was used and those for which it was not. The primary outcome was neonates delivered in an unexpected position. Neonatal and maternal morbidity were also assessed, including a neonatal composite of Apgar score <7 at 5 minutes, cord lactate >8 mmol/L, need for resuscitation, significant birth trauma, or neonatal intensive care unit admission. To control for confounding by indication, we estimated propensity scores for the probability of using intrapartum ultrasound for each case based on maternal and labor characteristics, and adjusted the effect estimates for the propensity scores using multivariable logistic regression models. RESULTS: From August 2022 to July 2023, there were 1205 operative vaginal births or fully dilated cesarean deliveries at Monash Health, including 743 (61.7%) forceps, 346 (28.7%) vacuum, and 116 (9.6%) fully dilated cesarean deliveries. Over this time, we observed increased uptake of intrapartum ultrasound from 26% in August 2022 to 60% (P<.001) in July 2023, of the time-out from 21% to 58% (P<.001), and the checklist from 33% to 80% (P<.001) of operative second-stage births. Among the births where intrapartum ultrasound was used (n=509), compared with those where it was not (n=696), there were significantly more forceps births (67% vs 58%; adjusted odds ratio, 1.35; 95% confidence interval, 1.05-1.74; P=.021) and a reduction in vacuum births (24% vs 32%; adjusted odds ratio, 0.77; 95% confidence interval, 0.58-1.01; P=.059). There were no significant differences in fully dilated cesarean delivery or maternal morbidity. Intrapartum ultrasound use was associated with significantly fewer infants being delivered in an unexpected position (0.2% vs 2.2%; adjusted odds ratio, 0.08; 95% confidence interval, 0.00-0.44; P=.019) and a significant reduction in composite neonatal morbidity (22% vs 25%; adjusted odds ratio, 0.73; 95% confidence interval, 0.54-0.97; P=.031). CONCLUSION: During the implementation of a safety bundle, the use of ultrasound before operative vaginal birth was associated with fewer infants delivered in an unexpected position and reduced neonatal morbidity.

Performance and validation of two ICU delirium assessment and severity tools; a prospective observational study.

BACKGROUND: The clinical statistical performance of the Confusion Assessment Method Intensive Care Unit (CAM-ICU, including CAM-ICU-7) and Intensive Care Delirium Screening Checklist (ICDSC) have rarely been studied. Additionally, delirium severity is often not measured due to a lack of validation of delirium assessment tools. OBJECTIVE: The aim was to determine the statistical performance of both delirium assessment tools in daily practice, and the correlation with the gold standard Delirium Rating Scale (DRS)-R98, for delirium severity. RESEARCH METHOD: CAM-ICU-7 and ICDSC, performed by nurses were compared with the DRS-R98 assessed by delirium experts, twice weekly. Within a time-window of one hour all assessments were independently performed. DESIGN: A prospective observational study performed between October and December 2020. MAIN OUTCOME MEASURES: Sensitivity, specificity, positive and negative predictive value of both tools was determined. The correlation between DRS-R98 and CAM-ICU-7 and ICDSC was used for validation of delirium severity. RESULTS: In total, 104 CAM-ICU-7 and 105 ICDSC assessments in 86 patients were compared with the DRS-R98. For the CAM-ICU-7 and ICDSC, respectively, the sensitivity was 90% and 95%, the specificity was 92.4% and 92.3%. The positive predictive value was 0.76 and 0.80, and negative predictive value was 0.77 and 0.97. Correlation of the CAM-ICU-7 score and ICDSC score with the DRS-R98 score was 0.74 (95% CI 0.64-0.81) and 0.70 (95%CI 0.59-0.79; both p < 0.001), respectively. CONCLUSION: Both CAM-ICU-7 and ICDSC demonstrated good statistical performance and correlated well with the delirium severity tool DRS-R98. IMPLICATIONS FOR CLINICAL PRACTICE: Nurses can either use the CAM-ICU(-7) or the ICDSC in their practice, both are accurate in delirium diagnosis. Total CAM-ICU-7 and ICDSC score reflects delirium severity well; the higher the score, the more severe the delirium. This enables nurses to gauge the impact of their interventions and enhance the well-being of patients experiencing delirium by minimizing distressing occurrences.

The German PCL-5: evaluating structural validity in a large-scale sample of the general German population.

Background: In attempts to elucidate PTSD, recent factor analytic studies resulted in complex models with a proliferating number of factors that lack psychometrical and clinical utility. Recently, suggestions have been made to optimize factor analytic practices to meet a refined set of statistical and psychometric criteria.Objective: This study aims to assess the factorial structure of the German version of the PCL-5, implementing recent methodological advancements to address the risk of overfitting models. In doing so we diverge from traditional factor analytical research on PTSD.Method: On a large-scale sample of the German general population (n = 1625), exploratory factor analyses were run to investigate the dimensionality found within the data. Subsequently, we validated and compared all model suggestions from our preliminary analyses plus all standard and common alternative PTSD factor models (including the ICD-11 model) from previous literature with confirmatory factor analyses. We not only consider model fit indices based on WLSMV estimation but also deploy criteria such as favouring less complex models with a parsimonious number of factors, sufficient items per factor, low inter-factor correlations and number of model misspecifications.Results: All tested models showed adequate to excellent fit in respect to traditional model fit indices; however, models with two or more factors increasingly failed to meet other statistical and psychometric criteria.Conclusion: Based on the results we favour a two-factor bifactor model with a strong general PTSD factor and two less dominant specific factors - one factor with trauma-related symptoms (re-experiencing and avoidance) and one factor with global psychological symptoms (describing the trauma's higher-order impact on mood, cognition, behaviour and arousal).From the perspective of clinical utility, we recommend the cut-off scoring method for the German version of the PCL-5. Basic psychometric properties and scale characteristics are provided.

We contribute new insights to the debate on the factor structure of the PTSD Checklist (PCL-5) based on a large German general population sample deploying the newest methodological developments in a revised factor-analytical approach.Combining theoretical, statistical and practical considerations, we favour a two-factor bifactor model with a strong general PTSD factor and two less dominant specific factors ­ one factor with trauma-related symptoms and one factor with global psychological symptoms.For clinical practitioners, we recommend using the cut-off scoring method.

The appearance of multidimensionality: Exploring the case for unidimensionality of the PTSD Checklist for DSM-5 using a firefighter sample.

Rasmussen et al. (2019) described the proliferation of factors for posttraumatic stress disorder (PTSD) measures and raised concerns about the construct validity of factors that include two or three items. In this brief report, we describe how the pattern of covariation among the responses to items of well-established measures, such as the PTSD Checklist for DSM-5 (PCL-5), can give the appearance of multidimensionality. We evaluated whether the structure of the 20-item PCL-5 is unidimensional, using the methods of multidimensional item response theory (MIRT) and the concept of a testlet. These analyses were done using a sample of trauma-exposed urban firefighters. A unidimensional and a bifactor model, which includes a general factor composed of all items and four specific factors mirroring the DSM-5 conceptualization, were evaluated for both Likert-type multiple-category and binary coding system of the PCL-5 item response data. Seven testlets were created from the 20 PCL-5 items following the seven-factor model (Armour et al., 2015) presented in Table 1 of Rasmussen et al. (2019). Findings using the unidimensional nominal item response theory model for the seven testlets indicated that the PCL-5 may be considered unidimensional with a single score representing individual differences on a continuum that ranges from low to high. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Ensuring treatment fidelity in intervention studies: Developing a checklist and scoring system within a behaviour change paradigm.

BACKGROUND: Treatment fidelity refers to the degree to which an intervention is implemented as intended. Promoting treatment fidelity is important to achieve a valid comparison in intervention research. However, it is often underreported: few studies detail the use and development of fidelity measures. This study aims to promote the treatment fidelity of a modified version of the Derbyshire Language Scheme (M-DLS), a manualised intervention for children with language difficulties, by exploring participants' opinions on training and intervention delivery. Results inform development of a checklist and scoring system to monitor and promote treatment fidelity in a comparison trial. METHOD: Ten student speech and language therapists (SLTs) and two research assistants (RAs) participated in the study. All received training on the M-DLS, and 10 were video-recorded completing role-plays of an M-DLS session in small groups. Feedback was gathered after training and role-plays in focus groups and interviews. Feedback was interpreted using the constructs of the Theoretical Domains Framework (TDF). A treatment fidelity checklist was then developed using the feedback. The first author and two RAs rated role-play videos using the checklist to trial it to inform amendments and to promote interrater reliability. Interrater agreement was calculated using Spearman's test of correlation. RESULTS: Participants discussed the importance of having clear materials and time to practise sessions. They suggested amendments to the materials and training to promote treatment fidelity. The checklist and scoring system accounted for participants' suggestions, with amendments detailed in a log. Spearman's correlation results suggested agreement between the raters was strong. CONCLUSIONS: Results emphasise the importance of training quality, practice and reflective opportunities and clear materials to promote treatment fidelity. The construction of the checklist and scoring system was described in detail, informing the development of future checklists. After further trialling, the checklist can be used to ensure the M-DLS is delivered with high treatment fidelity in the comparison trial. WHAT THIS PAPER ADDS: What is already known on this subject Treatment fidelity is an essential component of intervention effectiveness and efficacy studies, ensuring the intervention is delivered as intended. It is also an essential component of evidence-based clinical practice. However, few research studies report the treatment fidelity process or publish the checklists used, depriving clinicians of useful information for implementation. What this study adds This study describes in detail the iterative process of treatment fidelity checklist development, engaging those implementing the intervention in development. This ensured clarity and interrater reliability of the checklist. Furthermore, a novel scoring system was developed so that accuracy of implementation can be easily compared across users and across practice attempts. What are the clinical implications of this work? The importance of treatment fidelity when implementing effective and efficacious interventions cannot be overstated. The treatment fidelity checklist developed for research can be easily adopted to support accurate implementation in clinical practice through an audit process.

Emergency department staff experiences of the Bröset Violence Checklist.

AIM: Work-related violence is a significant problem in healthcare settings and emergency departments are one of the highest at-risk locations. There have been significant challenges in identifying successful risk-mitigation strategies to reduce the incidence and impact of work-related violence in this setting. This research explores the perspectives of clinical staff who routinely use violence risk assessment to provide recommendations for improvements. DESIGN: This qualitative research used interviews of staff who routinely use of the Bröset Violence Checklist in an emergency department. The study was conducted in April 2022. METHOD: Interview transcripts were subjected to Thematic Analysis to explore participants' clinical experiences and judgements about the utility of the Bröset Violence Checklist. RESULTS: Eleven staff participated in semi-structured interviews. Participants described themes about the benefits of routine violence risk assessment and the influence of the subjective opinion of the scorer with respect to the emergency department patient cohort. Four categories of violence risk factors were identified: historical, clinical, behavioural and situational. Situational risks were considered important for tailoring the tool for context-specificity. Limitations of the BVC were identified, with recommendations for context-specific indicators. CONCLUSION: Routine violence risk assessment using the Bröset Violence Checklist was deemed useful for emergency departments, however, it has limitations. IMPACT: This study's findings offer potential solutions to reduce violence affecting front-line workers and practical processes that organizations can apply to increase staff safety. IMPLICATIONS: The findings produced recommendations for future research and development to enhance utility of the Bröset Violence Checklist. REPORTING METHOD: EQUATOR guidelines were adhered to and COREQ was used. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution was involved in this study.

Transforming Team Performance Through Reimplementation of the Surgical Safety Checklist.

Importance: Patient safety interventions, like the World Health Organization Surgical Safety Checklist, require effective implementation strategies to achieve meaningful results. Institutions with underperforming checklists require evidence-based guidance for reimplementing these practices to maximize their impact on patient safety. Objective: To assess the ability of a comprehensive system of safety checklist reimplementation to change behavior, enhance safety culture, and improve outcomes for surgical patients. Design, Setting, and Participants: This prospective type 2 hybrid implementation-effectiveness study took place at 2 large academic referral centers in Singapore. All operations performed at either hospital were eligible for observation. Surveys were distributed to all operating room staff. Intervention: The study team developed a comprehensive surgical safety checklist reimplementation package based on the Exploration, Preparation, Implementation, Sustainment framework. Best practices from implementation science and human factors engineering were combined to redesign the checklist. The revised instrument was reimplemented in November 2021. Main Outcomes and Measures: Implementation outcomes included penetration and fidelity. The primary effectiveness outcome was team performance, assessed by trained observers using the Oxford Non-Technical Skills (NOTECH) system before and after reimplementation. The Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture was used to assess safety culture and observers tracked device-related interruptions (DRIs). Patient safety events, near-miss events, 30-day mortality, and serious complications were tracked for exploratory analyses. Results: Observers captured 252 cases (161 baseline and 91 end point). Penetration of the checklist was excellent at both time points, but there were significant improvements in all measures of fidelity after reimplementation. Mean NOTECHS scores increased from 37.1 to 42.4 points (4.3 point adjusted increase; 95% CI, 2.9-5.7; P < .001). DRIs decreased by 86.5% (95% CI, -22.1% to -97.8%; P = .03). Significant improvements were noted in 9 of 12 composite areas on culture of safety surveys. Exploratory analyses suggested reductions in patient safety events, mortality, and serious complications. Conclusions and Relevance: Comprehensive reimplementation of an established checklist intervention can meaningfully improve team behavior, safety culture, patient safety, and patient outcomes. Future efforts will expand the reach of this system by testing a structured guidebook coupled with light-touch implementation guidance in a variety of settings.

The structure of the Symptom Checklist-90-Revised: Global distress, Somatization, Hostility, and Phobic Anxiety scales are reliable and robust across community and clinical samples from four European countries.

While the reliability of SCL-90-R subscales is often questioned, five relatively recent European studies have examined the factor structure of SCL-90-R using a bifactor model and concluded that most of these subscales are reliable. However, examination of their results shows that three subscales, Somatization, Hostility, and Phobic Anxiety, consistently had significantly higher reliability than the other six across clinical and community samples recruited in three very different European countries, Greece, Hungary, and the Netherlands. The objective of this study was to examine whether this "top-3″ would be found in a sample from a fourth European country, France. To do this, we had 696 university students (387 women, 56 %) complete the SCL-90-R and we examined the reliability of the scales of this questionnaire by testing a bifactor model using Exploratory Structural Equation Modeling (ESEM). Our results confirmed that, in our sample, the three scales presented a higher reliability than the other six scales. It therefore seems that there exists, at least in the European cultural area, a stable structure of the SCL-90-R comprising a global distress factor and three reliable and robust specific factors: Somatization, Hostility, and Phobic Anxiety.

WHO Surgical Safety Checklist and Anesthesia Equipment Checklist efficacy in war-affected low-resource settings: a prospective two-arm multicenter study.

INTRODUCTION: The Russian invasion of Ukraine has caused huge damage to all medical infrastructure and impairs patient safety. The aim of our study was to assess the impact of implementation of the WHO Surgical Safety Checklist and Anesthesia Equipment Checklist on patient outcomes and adherence to safety standards in low-resource settings, affected by an ongoing war. MATERIAL AND METHODS: A prospective multicenter study was conducted in 6 large Ukrainian hospitals. The study was conducted in two phases: a control period, lasting five months, followed by a study period, when the two checklists (the WHO Surgical Safety Checklist and Anesthetic Equipment Checklist) were introduced in the designated operating rooms. The primary outcomes were any major complications, including death, during 30 days after surgery. RESULTS: A total of 2237 surgical procedures were recorded - 1178 in the control group and 1059 in the intervention group. Major postoperative complications occurred in 82 (6.9%) patients in the control group and in 25 (2.4%) in the study group (OR = 0.32 [0.19-0.52], P < 0.001). The effect on the incidence of specific postoperative complications was statistically significant for the "surgical infection" (1.5% vs. 0.1%; OR = 0.31 [0.1-0.8], P = 0.01) and "reoperation" (1.7% vs. 0.5%; OR = 0.32 [0.1-0.8], P = 0.01) cate-gories as well as for the 30-day mortality (1.3% vs. 0.3%; OR = 0.35 [0.1-0.9], P = 0.03). Better adherence to basic WHO surgical safety recommendations was observed for every check mentioned in the WHO Surgical Safety Checklist ( P < 0.05). CONCLUSIONS: The WHO Surgical Safety Checklist and the Anesthesia Equipment Checklist improve patient outcomes in war-affected low-resource settings.

Psychometric properties of the Polish version of the Post-traumatic Stress Disorder Check List according to DSM-5 - PCL-5. / Wlasciwosci psychometryczne polskiej wersji Listy Zaburzen po Stresie Traumatycznym wedlug DSM-5 ­ PCL-5.

OBJECTIVES: The changes in the structure of PTSD symptoms introduced in the DSM-5 classification require the use of an appropriate measurement tool. For this purpose, the PTSD Checklist (PCL-5) was constructed and popularized. In the presented studies, the psychometric properties of the Polish version of PCL-5 were assessed. In addition, referring to the controversy regarding the conceptualization of PTSD, various indicators of the fit of five PTSD structure models were checked based on our own research. METHODS: People (N = 1035) who experienced various traumatic events participated in the anonymous research. All completed PCL-5 and another questionnaires used to assess the validity of PCl-5. RESULTS: The psychometric properties of the Polish version of PCL-5 are satisfactory. In the differential diagnosis the optimal point of discrimination is the result of ⩾ 33. The CFA results showed that all tested PTSD models met the basic fit criteria. The four-factor model explained 58% of the variance, including changes in arousal and reactivity of 36%. CONCLUSIONS: PCL-5 is a reliable and accurate tool for PTSD measurement. It is used for the initial diagnosis of PTSD. The conducted analyzes, despite demonstrating the diagnostical utility of PCL-5, do not indicate ultimately favor a single PTSD dimensionality model.

Hospital Performance Evaluation Checklist in Context of COVID-19 Pandemic: Design and Validation.

OBJECTIVE: Around the world, pandemics have been considered among the main hazards in the last 2 decades. Hospitals are 1 of the most important organizations responding to pandemics. The aim of this study was to design and develop a valid checklist for evaluating the hospitals' performance in response to COVID-19 pandemic, for the first time. METHODS: This study is a mixed method research design that began in February, 2020 and was conducted in 3 phases: Designing a conceptual model, designing a primary checklist structure, and checklist psychometric evaluation. Known-groups method has been used to evaluate construct validity. Two groups of hospitals were compared: group A (COVID-19 Hospitals) and group B (the other hospitals). RESULTS: The checklist's main structure was designed with 6 main domains, 23 sub-domains, and 152 items. The content validity ratio and index were 0.94 and 0.79 respectively. Eleven items were added, 106 items were removed, and 40 items were edited. Independent t-test showed a significant difference between the scores of the 2 groups of hospitals (P < 0.0001). Pearson correlation coefficient test also showed a high correlation between our checklist and the other. The internal consistency of the checklist was 0.98 according to Cronbach's alpha test. CONCLUSIONS: Evaluating the hospitals' performance and identifying their strengths and weaknesses, can help health system policymakers and hospital managers, and leads to improved performance in response to COVID-19.

A scoping review of the self-reported compassion measurement tools.

BACKGROUND: Compassion is closely linked to psychological well-being, and several assessment tools have been developed and studied to assess the level of compassion in different populations and for more precise measurement. There is currently a scarcity of comprehensive knowledge about compassion-related assessment tools, and our research provides an overview of these tools. AIMS: To identify scales used to measure compassion from different flows, and to assess their measurement properties and quality. METHODS: Focusing on compassion assessment tools, the authors conducted a thorough search of 10 Chinese and English databases from their establishment until August 14, 2022. Data extracted included the author, year, country, objectives, target population, as well as the primary evaluation content. Using the COSMIN checklist, the methodological quality and measurement properties of the included studies were appraised. This scoping review was registered with the Open Science Framework and followed the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) checklist. RESULTS: There were 15,965 papers searched, and 36 compassion-related measurement tools were identified in this study. None of the 36 studies provided possessed all nine psychometric properties, as outlined by the COSMIN criteria. On the basis of a systematic evaluation of quality, measurement qualities were ranked. The results for internal consistency and content validity were relatively favorable, whereas the results for structural validity were variable and the results for the remaining attributes were either uncertain or negative. A Venn diagram was used to illustrate the overlapping groups of compassion measurement tools based on the three-way flow of compassion. An overview of the reference instrument and theoretical basis for the included studies was provided, and half of them did not contain any theoretical or scale-based evidence. CONCLUSION: In this study, 36 compassion-related measuring instruments were identified, and the methodological quality and measurement properties of the included studies were acceptable. The included measurements were consistent with flows of compassion. A further focus of further research should be on developing theories in the compassion domain and developing instruments for measuring compassion that are multidimensional, multi-populations, and culturally relevant.

[Surgical safety checklist for surgical interventions]. / Kontrol'nyi list khirurgicheskoi bezopasnosti pri vypolnenii operativnykh vmeshatel'stv.

The review is devoted to mostly international data on patient safety during surgical procedures. The author emphasizes surgical safety checklist for surgical interventions as a tool developed by the WHO team. The principal objective of this document is protection of patients from harm following unintended misses and casual circumstances. The author tried to explain the basic principles and ideas underlying the checklist procedure. An importance of understanding the process by administration and surgical team is emphasized because its absence deprives this non-complicated and helpful procedure of necessary sense. The problems of patient safety in hospitals of the Russian Federation are also discussed.

[Translated article] Checklist for the pharmaceutical care of patients with interstitial lung disease (CheckEPID): A Delphi-based consensus.

OBJECTIVE: To develop a checklist to facilitate pharmaceutical care for patients with interstitial lung disease who require or are undergoing treatment with antifibrotic drugs. METHOD: Five hospital pharmacists developed an initial list of 37 items divided into 4 blocks: (1) First visit, which included general patient data and data from the first treatment; (2) follow-up visits, assessing aspects of the follow-up of the treatment with nintedanib or pirfenidone; (3) telepharmacy, consisting of the evaluation of the inclusion of patients in a program of this type, course of the disease, and identification of the contact with the pharmacy service; (4) non-pharmacological treatment and patient information. To decide its potential inclusion in the checklist, 2 rounds of the Delphi were carried out in which the panelists had to assess the degree of agreement of each proposed item according to its "utility", which was the determining criterion for its inclusion, and its "applicability". RESULTS: Forty-eight hospital pharmacists were contacted, 30 (63%) agreed in writing to participate, 28 (58%) completed the first round of the Delphi, and 27 (56%) completed the second round. After the first round of the Delphi, the questionnaire was amended and comprised 40 items. Of the 40 items evaluated after the 2 rounds of the Delphi, there were 2 that, based on utility, the participants did not reach consensus for inclusion in the checklist: the one referring to "History of surgical intervention, specifically abdominal surgery in the last 4 weeks" (finally kept on the checklist due to its involvement in the indication of nintedanib) and to make recommendations on "Relaxation". No consensus was reached on their applicability for 2 of the items: "Patient stratification according to the Spanish Society of Hospital Pharmacy (SEFH) chronic patient model" and "Collection of Results Reported by the Patient". CONCLUSIONS: The management of patients with ILD and/or pulmonary fibrosis is complex and requires a multidisciplinary approach where the hospital pharmacist plays a key role, especially, although not only, in monitoring drug treatment. We believe that this checklist can contribute from pharmaceutical care to improving the integrated care of patients with ILD who require or are undergoing treatment with antifibrotic drugs.

A retrospective analysis of the factors associated with surgical checklist compliance using data from a local health unit in Italy, 2018-2021.

RATIONALE: Since its publication, the World Health Organization Surgical Safety Checklist (SSC) has been progressively adopted by healthcare providers around the world to monitor and safeguard the delivery of surgeries. In one Italian region's health system, the SSC and other two surgery-specific checklists were supplemented by a document that records any non-conformity (NC) arising from the safety checks. AIMS AND OBJECTIVES: In this study, we investigated the factors associated with NCs using data from a local health unit (LHU). The secondary aim of this study was to explore the potential impact of the coronavirus crisis on surgical checklist compliance. METHODS: We used data on surgical activity from the Modena LHU between 2018 and 2021 and the accompanying NC documents. The primary goal was to estimate the relative risk (RR) of NCs according to several factors, including checklist incompleteness and surgery class (elective, urgent or emergency), using Poisson regression. A similar analysis was performed separately for 2018-2019 and 2020-2021 to assess the COVID-19 potential impact. RESULTS AND CONCLUSIONS: Checklist compliance in the LHU was 95%, with the presence of NCs in about 7% of surgeries. The factors that increased the RR were incompleteness of the checklist (adjusted RR = 3.12; 95% confidence interval [CI] = 2.86-3.40), urgent surgeries (adjusted RR [aRR] = 1.59; 95% CI = 1.47-1.72), emergencies (aRR = 2.09; 95% CI = 1.15-3.79), and surgeries with more than four procedures (aRR = 1.64; 95% CI = 1.41-1.92). Most notably, the RR for incomplete checklists showed a negative association with NCs before the COVID-19 outbreak but positive afterwards. Checklist compliance was overall satisfactory, though the observation of noncompliant checklists of about 1000 per year suggests there is still room for improvement. Moreover, attention to the checklist best practices and organization of outpatient workload may have been affected by the exceptional circumstances of the pandemic.

Methodological assessment and overall confidence in the results of systematic reviews with meta-analyses focusing on traumatic dental injuries: A cross-sectional study.

BACKGROUND/AIMS: High methodological quality is required to interpret results of systematic reviews (SRs) in a reliable and accurate manner. The primary aim of this study was to appraise the methodologic quality of SRs with meta-analysis within the field of traumatic dental injuries using the A MeaSurement Tool to Assess systematic Reviews (AMSTAR) 2 tool and assess overall confidence in their results. A secondary aim was to identify potential predictive factors associated with methodological quality. MATERIALS AND METHODS: SRs with meta-analyses published in English in the field of traumatic dental injuries from inception to March 2023 were identified. The methodological quality of the included reviews was assessed using the AMSTAR 2 checklist. Two independent evaluators scored each AMSTAR 2 item as "yes" if it was adequately addressed, "partial yes" if it was partially addressed, and "no" if it was not addressed. The overall confidence in the results of each review was classified as "High," "Moderate," "Low," or "Critically low." Using multiple regression, the relationship between five predictor variables (journal impact factor, year of publication, number of authors, journal adherence to Preferred Reporting Items for Systematic reviews and Meta-analyses [PRISMA] guidelines and a priori protocol registration) and the total AMSTAR 2 scores was analyzed. The p-value was 5%. RESULTS: Forty-one SRs were included. The overall confidence in the results of 13 reviews was categorized as "Critically low," 18 as "Low," 3 as "Moderate" and 7 as "High." Among the five predictor variables analyzed statistically, impact factor of the journal and year of publication significantly influenced the total AMSTAR 2 scores. The number of authors, adherence to PRISMA guidelines, and a priori protocol registration had no significant impact on AMSTAR 2 scores. CONCLUSION: The overall confidence in the results of SRs with meta-analysis within the field of traumatic dental injuries was "Low" or "Critically Low" in the vast majority of studies (31 of 41). SRs with meta-analyses published in journals with higher impact factors and more recent publications had significantly higher methodological quality.