Infant's Behaviour Checklist for low birth weight infants and later neurodevelopmental outcome.

Assessment of the characteristics of spontaneous movements and behaviour in early infancy helps in estimating developmental outcomes. We introduced the Infant Behaviour Checklist (IBC) and examined the relationship between the behavioural characteristics of low-birth-weight infants and neurodevelopmental outcomes at 6 years of age. The behavioural characteristics during the neonatal (36-43 weeks, adjusted) and early infancy periods (49-60 weeks, adjusted) were assessed in very-low-birth-weight infants. The IBC includes 44 common behaviours. We assessed the appearance of individual behavioural characteristics at each period according to the neurodevelopmental outcome. Of the 143 infants assessed during the neonatal period, 89 had typical development (TD), 30 had intellectual disability (ID), and 24 had autism spectrum disorder (ASD). In 78 infants assessed during early infancy, 40, 21, and 17 had TD, ID, and ASD, respectively. The frequency of appearance of three behaviour-related items was significantly lower in the ID group than in the TD group. The frequency of appearance of three posture- and behaviour-related items was significantly lower, while that of two posture-related items was significantly higher, in the ASD group than in the TD group. Behavioural assessment using the IBC may provide promising clues when considering early intervention for low-birth-weight infants.

Safe birth matters: facilitators and barriers to uptake of the WHO safe childbirth checklist tool in a Tanzania Regional Hospital.

BACKGROUND: The World Health Organization (WHO) developed the Safe Birth Checklist (SCC) to facilitate best practices in safe birthing practices. The SCC is utilizing existing evidence-based WHO guidelines and recommendations which has combined those into a single and practical bedside tool. The SCC is the first checklist-based intervention to target the prevention of maternal and neonatal deaths. OBJECTIVE: The objective of this project was to pilot-test the World Health Organization Safe Childbirth Checklist with Maternity Regional Hospital in, Tanzania. STUDY DESIGN AND METHODS: Retrospective analysis on 35 charts were completed to identify presence or absence of documentation aligned with evidenced based checklist items. Staff training, end user observations and focus group discussions were utilized to elicit feedback about the tool and the process. Descriptive statistics and manual content analysis were used to analyze the rate of uptake and ownership over the checklist. The Checklist is broken down into four sections or time points (that are considered natural pause points in the care of laboring women). The four different pause points are admission, delivery, post-partum, and discharge. RESULTS: We trained 26 participants out of 32 staff how to use the SCC. Delivery time point had the lowest at SCC completion rate at 39% compared to discharge having the highest completion rate at 93%. There was variation in completion rate of the checklist items at each time point. Checklist items at the beginning of each time point were completed between 94% and 100% of the time with the latter checklist list items completed between 29% and 57% of the time. CONCLUSION: This project was able to identify facilitators and potential barriers to the successful uptake of the Safe Childbirth Checklist in Shinyanga Regional Hospital. Based on these findings, the MOH have opportunities to utilize those findings in the scale-up of the implementation of the checklist and future evaluation activities.

[Interobserver agreement in using a checklist for the safe administration of enteral nutrition]. / Concordancia entre observadores en la aplicación de la lista de verificación para la administración segura de la nutrición enteral.

INTRODUCTION: Objective: to describe an evaluation of interobserver agreement in the use of a checklist related to the use of nasoenteral tube (NSS) as a presupposition for quality in obtaining data. Method: a methodological study conducted in 2018 in a Brazilian hospital, preceding the data collection of an open-label clinical trial. Independent observers, blinded to the evaluation of their peers, evaluated patients with NSS through a 25-item checklist. The data collected by eight previously trained research assistants (RA) were compared to those obtained by an experienced nurse (reference standard). Agreement was measured using the kappa coefficient and PABAK. Results: a total of 451 observations were made in pairs. Considering the total items on the checklist there was almost perfect agreement (k > 0.80) in all observation pairs (nurse vs. each RA): RA 1 (k = 0.91; 95 % CI = 0.89-0.93); RA 2 (k = 0.83; 95 % CI = 0.80-0.85); RA 3 (k = 0.92; 95 % CI = 0.90-0.94); RA 4 (k = 0.83; 95 % CI = 0.80-0.86); RA 5 (k = 0.94; 95 % CI = 0.92-0.96); RA 6 (k = 0.94; 95 % CI = 0.92-0.96); RA 7 (k = 0.96; 95 % CI = 0.95-0.98); RA 8 (k = 0.73; 95 % CI = 0.70-0.77). However, for isolated items, and in specific RAs, there were fair agreements, unacceptable to effectively collect data from a clinical trial. Retraining and supervision of RAs were able to improve agreement between observers. Conclusion: an evaluation of interobserver agreement proved to be fundamental to ensure the reliability of data collection and, therefore, to avoid measurement biases.

INTRODUCCIÓN: Objetivo: describir una evaluación de la concordancia entre observadores en el uso de una lista de verificación en la atención a pacientes con sonda nasoenteral (SNE) como premisa de la recogida de datos. Método: este estudio de fiabilidad se realizó en 2018 en un hospital brasileño, antes de la recogida de datos para un ensayo clínico abierto. Ocho observadores independientes, previamente capacitados y "cegados" con respecto a las evaluaciones de los demás, evaluaron a pacientes con SNE por medio de una lista de comprobación de 25 elementos. Los datos obtenidos por estos asistentes de investigación (AI) se compararon con los obtenidos por una enfermera experimentada. Se midió la concordancia mediante los coeficientes kappa y PABAK. Resultados: se realizaron 451 observaciones por pares. Considerando la totalidad de los elementos, hubo una concordancia casi perfecta (k > 0,80) en todos los pares de observación (enfermera vs. cada AI): AI 1 (k = 0,91; IC95 % = 0,89-0,93); AI 2 (k = 0,83; IC95 % = 0,80-0,85); AI 3 (k = 0,92; IC95 %= 0,90-0,94 ); AI 4 (k = 0,83; IC95 % = 0,80-0,86); AI 5 (k = 0,94; IC95 % = 0,92-0,96); AI 6 (k = 0,94; IC95 % = 0,92-0,96); AI 7 (k = 0,96; IC95 % = 0,95-0,98); AI 8 (k = 0,73; IC95 % = 0,70-0,77). Se identificó un menor número de concordancia en los elementos individuales y en determinados AI. La recapacitación y supervisión de los AI mejoró su desempeño y la concordancia entre observadores. Conclusión: la evaluación de la concordancia entre observadores resultó fundamental para asegurar la fiabilidad de la recogida de datos y, por consiguiente, evitar sesgos de medición en los estudios clínicos de enfermería.

"Evidence-based checklists" for identifying predatory journals have not been assessed for reliability or validity: An analysis and proposal for moving forward.

BACKGROUND: Predatory journals (PJs) pose a threat to the quality/integrity of scientific publishing. Checklists have been proposed to identify PJs, but few are "evidence-based". This study's objective was to search for/assess evidence-based checklists (EBCs) for reliability and validity, based on a new consensus definition of PJs. METHODS: A published methods guideline for scale development was used to identify how many steps were completed in the generation of identified EBCs. Items from each EBC were compared against the consensus definition, and a list of items to be considered in the creation of a composite EBC to identify PJs was generated. RESULTS: Four EBCs were identified. None of these had completed the first of the nine steps for scale development and validation. Forty-seven items from the four EBCs were assessed against the consensus definition, of which 28 items fell within the definition. A proposed composite EBC was created from items matching components of the consensus definition. CONCLUSION: EBCs to detect PJs lack assessment of reliability and validity. To a varying degree, the EBCs contain items that match the scope of the new consensus definition of PJs. With the recent consensus definition, EBCs creators now have a clearer target, and can make adjustments.

The impact of a surgical checklist on surgical outcomes in an academic institution.

OBJECTIVE: To determine the influence of a surgical checklist (SC) on morbidities and compliance with safety measures. STUDY DESIGN: Before-and-after-intervention study. SAMPLE POPULATION: Three thousand two hundred eighty-six dogs: 1375 dogs pre-SC and 1911 post-SC. METHODS: Completion of safety measures and occurrence of morbidity and/or mortality during hospitalization and up to death or 30-days postoperatively were recorded. RESULTS: Safety measures were more frequently completed post-SC, including oral confirmation of patient identity (467/1177 [40%] vs. 1911/1911 [100%]) and oral confirmation of surgical site (568/1175 [48%] vs. 1911/1911 [100%]). In addition, duration of anesthesia decreased from 241 to 232 min (t = 2.824; p = .005); a greater proportion of animals that were intended to receive antibiotics did so prior to incision (1142/1316 [86.8%] vs. 1656/1845 [89.8%] [χ2 = 6.70, p = .01]); and fewer dogs had unplanned return to the OR (32/1065 [3.0%], vs. 21/1472 [1.4%]) (χ2 = 7.52, p = .006). No difference in surgical site infection (adjusted odds ratio 1.02 [95%CI: 0.63-1.66]); morbidity, (adjusted odds ratio 1.00 [95%CI: 0.77-1.29]); or death within 30 days (adjusted odds ratio 1.15 [95%CI: 0.72-1.83]) was detected on multivariable logistic regression analysis. The checklist prevented one wrong-site surgery. CONCLUSION: Implementation of the checklist at our institution led to a decrease in anesthesia duration, increased administration of planned perioperative antibiotics before incision, increased completion of safety measures, and decreased unexpected return to the OR. IMPACT: Despite the lack of effect on morbidities, the use of SC is recommended to improve compliance with safety measures and potentially prevent rare catastrophic events.

A simulation-based pilot study of crisis checklists in the emergency department.

Checklists can improve adherence to standardized procedures and minimize human error. We aimed to test if implementation of a checklist was feasible and effective in enhancing patient care in an emergency department handling internal medicine cases. We developed four critical event checklists and confronted volunteer teams with a series of four simulated emergency scenarios. In two scenarios, the teams were provided access to the crisis checklists in a randomized cross-over design. Simulated patient outcome plus statement of the underlying diagnosis defined the primary endpoint and adherence to key processes such as time to commence CPR represented the secondary endpoints. A questionnaire was used to capture participants' perception of clinical relevance and manageability of the checklists. Six teams of four volunteers completed a total of 24 crisis sequences. The primary endpoint was reached in 8 out of 12 sequences with and in 2 out of 12 sequences without a checklist (Odds ratio, 10; CI 1.11, 123.43; p = 0.03607, Fisher's exact test). Adherence to critical steps was significantly higher in all scenarios for which a checklist was available (performance score of 56.3% without checklist, 81.9% with checklist, p = 0.00284, linear regression model). All participants rated the checklist as useful and 22 of 24 participants would use the checklist in real life. Checklist use had no influence on CPR quality. The use of context-specific checklists showed a statistically significant influence on team performance and simulated patient outcome and contributed to adherence to standard clinical practices in emergency situations.

Implementing a modified World Health Organization safe childbirth checklist in health centers of Ethiopia: a pre and post intervention study.

BACKGROUND: Childbirth is a complex process, and checklists are useful tools to remember steps of such complex processes. The World Health Organization safe childbirth checklist is a tool used to improve the quality of care provided to women giving birth. The checklist was modified by Ministry of Health and was introduced to health centers in Ethiopia by the USAID Transform: Primary Health Care Activity. METHODS: A pre and post intervention study design with prospective data collection was employed. The availability of essential childbirth supplies and adherence of health care providers to essential birth practices were compared for the pre and post intervention periods. RESULTS: The pre and post intervention assessments were conducted in 247 and 187 health centers respectively. A statistically significant improvement from 63.6% pre intervention to 83.5% post intervention was observed in the availability of essential childbirth supplies, t (389.7) = - 7.1, p = 0.000. Improvements in adherence of health care providers to essential birth practices were observed with the highest being at pause point three (26.2%, t (306.3) = - 10.6, p = 0.000) followed by pause point four (21.1%, t (282.5) = - 8.0, p = 0.000), and pause point two (18.2%, t (310.8) = - 9.7, p = 0.000). The least and statistically non-significant improvement was observed at pause point one (3.3%, t (432.0) = - 1.5, p = 0.131). CONCLUSION: Improvement in availability of essential childbirth supplies and adherence of health care providers towards essential birth practices was observed after introduction of a modified World Health Organization safe childbirth checklist. Scale up of the use of the checklist is recommended.

Office-Based Procedure Training in Laryngology Fellowship Programs.

OBJECTIVE: To assess the current practices and challenges of training office-based procedures to laryngology fellows in the United States. METHODS: An anonymous web-based survey study was distributed to laryngology fellowship program directors, as listed by the American Laryngological Association. The survey was a 19-item questionnaire with free-text, Likert scale, and multiple-choice answers. RESULTS: Twenty-two of 27 program directors (81.4%) replied to the survey. Many programs (8/16) have three or more laryngologists and do more than 10 procedures each week (10/16). Sixty-nine percent (11/16) of directors had not been trained for office procedures in their fellowship. The fellows are allowed to be primary surgeon on 68.75% and 75% of vocal fold augmentation and laser procedures, respectively. The expected competencies for these procedures on graduation are average-moderate and moderate. When program directors asked about the methods used for training, a minority of them use simulators (2/16), procedural checklists (2/16), or structured debriefing (2/16). The most commonly used methods were case-based troubleshooting (13/16) and unstructured debriefing (13/16). Patients being awake and patients' expectations are seen as the most important obstacles. Most of the directors thought office-based procedure training could be improved (14/16). The most common suggestions were using step-wise checklists, simulator-labs, and formal debriefings. CONCLUSION: This is the first study evaluating the training of office-based laryngeal procedures during laryngology fellowship. Given the increasing importance of these procedures in practice and the herein identified barriers and need for improvement, fellowships should investigate the use of systematic training tools to improve fellow competency with office-based procedures. Laryngoscope, 131:2054-2058, 2021.

Multi-Disciplinary Trauma Evaluation and Management Simulation (MD-TEAMS) training for emergency medicine and general surgery residents.

BACKGROUND: Successful trauma resuscitation relies on multi-disciplinary collaboration. In most academic programs, general surgery (GS) and emergency medicine (EM) residents rarely train together before functioning as a team. METHODS: In our Multi-Disciplinary Trauma Evaluation and Management Simulation (MD-TEAMS), EM and GS residents completed manikin-based trauma scenarios and were evaluated on resuscitation and communication skills. Residents were surveyed on confidence surrounding training objectives. RESULTS: Residents showed improved confidence running trauma scenarios in multi-disciplinary teams. Residents received lower communication scores from same-discipline vs cross-discipline faculty. EM residents scored higher in evaluation and planning domains; GS residents scored higher in action processes; groups scored equally in team management. Strong correlation existed between team leader communication and resuscitative skill completion. CONCLUSION: MD-TEAMS demonstrated correlation between communication and resuscitation checklist item completion and communication differences by resident specialty. In the future, we plan to evaluate training-related resident behavior changes and specialty-specific communication differences by residents.

Use of a surgical safety checklist after implementation in an academic veterinary hospital.

OBJECTIVE: To determine the use and barriers to uptake of a surgical safety checklist (SSC) after implementation in a veterinary teaching hospital. STUDY DESIGN: Voluntary online survey and retrospective study. SAMPLE POPULATION: All personnel actively involved in the Ontario Veterinary College Health Sciences Centre small animal surgery service between October 2, 2018 and June 28, 2019. METHODS: Surgical case logs and electronically initiated SSC were reviewed to calculate checklist use. The sample population was surveyed to identify factors and barriers associated with use of the SSC. Participants were allowed 1 month to respond, and five reminder emails were sent. RESULTS: Forth-one of 50 (82%) participants completed the survey. The SSC was used in 374 of 784 (47.7%) surgeries. Use rates declined over sequential three-month intervals (P < .0001). Twenty-six of 41 (63%) respondents overestimated checklist use. Staff attitudes were largely supportive of the SSC, with 29 of 41 respondents suggesting mandatory application. Forgetfulness, hierarchal concerns, timing issues, perceived delays in care, lack of clarity regarding roles, and inadequate training were identified as obstacles to use of the SSC. CONCLUSION: The SCC tested in this study was used in approximately half of the surgical procedures performed after its implementation. Hospital personnel were supportive of the SSC; forgetting to use the SSC was the most common barrier identified by respondents (24/41 [59%]). CLINICAL SIGNIFICANCE: The SSC implementation experience and user feedback described here should be taken into consideration to improve design and implementation of future SSC.

Improving the quality of childbirth services in Zambia through introduction of the Safe Childbirth Checklist and systems-focused mentorship.

Although strong evidence exists about the effectiveness of basic childbirth services in reducing maternal and newborn mortality, these services are not provided in every childbirth, even those at health facilities. The WHO Safe Childbirth Checklist (SCC) was developed as a job aide to remind health workers of evidenced-based practices to be provided at specific points in the childbirth process. The Zambian government requested context-specific evidence on the feasibility and outcomes associated with introducing the checklist and related mentorship. A study was conducted on use of the SCC in four facilities in Nchelenge District of Zambia. Observations of childbirth services were conducted just before and six months after the introduction of the intervention. Observers used a structured tool to record adherence to essential services indicated on the checklist. The primary outcome of interest was the change in the average proportion of essential childbirth practices completed. Feedback questionnaires were administered to health workers before and six months after the intervention. At baseline and endline, 108 and 148 pause points were observed, respectively. There was an increase from 57% to 76% of tasks performed (p = 0.04). Considering only these cases where necessary supplies were available, health workers completed 60% of associated tasks at baseline compared to 84% at endline (p<0.01). Some tasks, such as taking an infant's temperature and hand washing, were never or rarely performed at baseline. Feedback from the health workers indicated that nearly all health workers agreed or strongly agreed with positive statements about the intervention. The performance of health workers in Zambia in completing essential practices in childbirth was low at baseline but improvements were observed with the introduction of the SCC and mentorship. Our results suggest that such interventions could improve quality of care for facility-based childbirth. However, national-level commitment to ensuring availability of trained staff and supplies is essential for success. Trial registration Clinical Trials.gov (NCT03263182) Registered August 28, 2017 This study adheres to CONSORT guidelines.

Are anemia, gastrointestinal disorders, and pregnancy outcome associated with pica behavior?

OBJECTIVE: This study was conducted to determine the relationship between pica and anemia, gastrointestinal disorders, as well as pregnancy outcomes in pregnant women. METHODOLOGY: This study was a prospective study carried out between January 2016 and June 2017 and was performed on 226 pregnant women who attended four different health care centers to receive routine prenatal care. Sampling was done considering the inclusion criteria, in two steps: cluster sampling and random sampling. Data collection was done using a researcher-made checklist. The significance level was set at p = 0.05. RESULTS: The average age of the participants was 26.10±6.27. The prevalence of pica in pregnant women in the first, second, and third trimesters was 9.3, 8, and 2.1%, respectively. The most common pica craving among pregnant women was for ice and frozen materials (68.2%). There was a statistically significant relationship between gastrointestinal disorders and anemia with pica (p < 0.001). There was also a significant relationship between birth weights of babies born to mothers with pica and those without pica (p = 0.005). CONCLUSION: Pica in pregnant women had a significant relationship with gastrointestinal disorders and anemia during pregnancy and pregnancy outcomes. Thus, in addition to providing healthcare services, health care professionals should consider patients' pica practices and make the necessary interventions.

Evaluation of websites reached using Google in the modern digital era related to approach to cholesterol.

OBJECTIVE: The Google search engine is widely used as a source of medical information; however, legal and medical governance of the accuracy of the content retrieved is lacking. The aim of this study was to assess the most read Turkish-language texts related to cholesterol during a specific period according to the validity of the content. METHODS: Google Trends was queried on January 5, 2019 for the search term 'cholesterol' and the 9 other most popular search phrases used in Turkey that included the word cholesterol. In all, 100 links were obtained for each phrase, generating a total of 1000 links. Once duplicates were eliminated, a total of 604 links was used for the study. Since there is currently no validation scoring system for this purpose in the literature, the authors created a checklist according to well-accepted recent guidelines focused on cholesterol. The content of the texts acquired was classified as misleading, insufficient but favorable, or sufficient and favorable. RESULTS: The source of the online texts studied was universities (n=8, 1.3%), hospitals (n=6, 0.9%), personal blogs (n=200, 33.1%), health websites (n=183, 30.2%), and medical journals (n=207, 34.2%). In all, 235 texts (38.9%) were classified as sufficient and favorable and 35 (5.7%) were categorized as misleading. A medical practitioner was named in 378 texts (62.5%). All of the results from universities and hospitals were ranked in the favorable group. A statistical difference in the word count was seen in a comparison of the misleading and favorable texts. CONCLUSION: Google can connect users to a significant quantity of material related to cholesterol that includes a wide range from misleading information to sufficient and favorable texts. The variation in the quality of the content on websites accessible via Google necessitates that cholesterol resource material should be selected with great care.

Examining the use of the FIGO Nutrition Checklist in routine antenatal practice: multistakeholder feedback to implementation.

OBJECTIVE: To gain insights from pregnant women and obstetricians on the utility of the FIGO Nutrition Checklist in antenatal practice. METHODS: Women were recruited from the antenatal department of a large tertiary-level university maternity hospital in Dublin, Ireland, between October and December 2019. Participants completed the FIGO Nutrition Checklist before their routine antenatal appointment. Obstetricians and women were encouraged to discuss the FIGO Nutrition Checklist during the clinical visit. Completed FIGO Nutrition Checklists were collected after appointments. Acceptability was assessed through questionnaires. RESULTS: The majority (80.0%) of women answered "No" to at least one diet quality question, indicating a potential nutritional risk. While none of the participating obstetricians routinely discussed nutrition with women, all agreed that using the Checklist encouraged them to address nutrition with pregnant women. Nearly every woman (99.0%) found the Checklist quick to complete; however, all participating obstetricians felt there was not enough time to discuss it in routine practice. Despite this, most obstetricians and pregnant women recommended the FIGO Nutrition Checklist for use. CONCLUSION: The FIGO Nutrition Checklist is acceptable for use in routine antenatal practice in tertiary care settings. It helped identify potentially at-risk women during early pregnancy and facilitated conversations related to optimum diet.

Impact of the Norwegian National Patient Safety Program on implementation of the WHO Surgical Safety Checklist and on perioperative safety culture.

OBJECTIVES: Our primary objective was to study the impact of the Norwegian National Patient Safety Campaign and Program on Surgical Safety Checklist (SSC) implementation and on safety culture. Secondary objective was associations between SSC fidelity and safety culture. We hypothesised that the programme influenced on SSC use and operating theatre personnel's safety culture perceptions. SETTING: A longitudinal cross-sectional study was conducted in a large Norwegian tertiary teaching hospital. PARTICIPANTS: We invited 1754 operating theatre personnel to participate in the study, of which 920 responded to the surveys at three time points in 2009, 2010 and 2017. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome was the results of the patient safety culture measured by the culturally adapted Norwegian version of the Hospital Survey on Patient Safety Culture. Our previously published results from 2009/2010 were compared with new data collected in 2017. Secondary outcome was correlation between SSC fidelity and safety culture. Fidelity was electronically recorded. RESULTS: Survey response rates were 61% (349/575), 51% (292/569) and 46% (279/610) in 2009, 2010 and 2017, respectively. Eight of the 12 safety culture dimensions significantly improved over time with the largest increase being 'Hospital managers' support to patient safety' from a mean score of 2.82 at baseline in 2009 to 3.15 in 2017 (mean change: 0.33, 95% CI 0.21 to 0.44). Fidelity in use of the SSC averaged 88% (26 741/30 426) in 2017. Perceptions of safety culture dimensions in 2009 and in 2017 correlated significantly though weakly with fidelity (r=0.07-0.21). CONCLUSION: The National Patient Safety Program, fostering engagement from trust boards, hospital managers and frontline operating theatre personnel enabled effective implementation of the SSC. As part of a wider strategic safety initiative, implementation of SSC coincided with an improved safety culture.

Checklists in community care: reducing differences in care delivery between regular and relief staff to improve consistency and client experience.

BACKGROUND: Today, healthcare is more complex than just ensuring clients receive quality care; it also involves consistently delivering excellent client experience. A non-profit community support services agency conducted an extensive diagnostic journey to determine root causes of inconsistent care delivery between regular and relief frontline staff. LOCAL PROBLEM: Clients and family caregivers noted lower satisfaction in care delivery when a relief staff (ie, internal staff or an external agency that is covering a shift) provided service in comparison with their regular staff. The diagnostic journey discovered that the shift exchange process-when outgoing staff transfers critical knowledge to incoming staff for continuing care-varied significantly between the 11 service locations, leading to a lack of consistent service delivery, thereby impacting client experience. METHODS: A working group consisting of Supervisors of Client Services, Personal Support Workers (PSW) and management were tasked with process mapping the current state, highlighting gaps and outlining the ideal state of the shift exchange process. INTERVENTIONS: Using best practices from the aviation industry, a checklist was developed that encapsulated all the critical steps needed to be undertaken for a successful, consistent shift exchange. The theory was that the utilisation of the checklist would enable consistency and improve client satisfaction with care delivery, especially when care is delivered by a staff unfamiliar with clients. RESULTS: Prior to the checklist implementation, 74% of clients were satisfied or very satisfied with their relief staff, and post checklist implementation client satisfaction improved to 90%. Staff self-assessments also indicated that PSWs agreed that the checklist helped provide consistent care. CONCLUSION: The use of checklists can transform the way care is delivered in the community support sector and other service delivery agencies alike to bring greater standardisation of care between providers, thus significantly improving client experience across the healthcare sector.

The Applicability of a Checklist for the Diagnosis and Treatment of Exocrine Pancreatic Insufficiency: Results of the Italian Exocrine Pancreatic Insufficiency Registry.

OBJECTIVE: To evaluate a rapid checklist capable of identifying exocrine pancreatic insufficiency in outpatients. METHODS: Prospective observational study of a multicenter cohort. RESULTS: One hundred and two patients were enrolled; 61.8% of the patients had medically-treated benign or malignant pancreatic disease, and 38.2% had a pancreatic resection. Visual examination of the feces was evaluated in 84 patients and it was related to steatorrhea in 51 patients (50.0%). Receiver operating characteristic curves were evaluated for each symptom or clinical sign and four of them (ie, increase in daily bowel movements, number of bowel movements, fatty stools, >10% weight loss) had a satisfactory area under the curve. At multivariate analysis, fatty stools and >10% weight loss entered into this analysis having an area under the curve of 0.916 (95% confidence interval, 0.851-0.981). At 1 month and at one year of follow-up, the pancreatic enzyme replacement therapy administered showed that pancreatic extracts were able to significantly improve the increase in daily bowel movements, the number of bowel movements, fatty and bulky stools and >10% weight loss. CONCLUSION: Both fatty stools and >10% weight loss were able to clinically evaluate steatorrhea, and their improvement was sufficient to evaluate substitution therapy.

Guidance for the Conduct and Reporting of Clinical Trials of Breast Milk Substitutes.

Importance: Breast milk substitutes (BMS) are important nutritional products evaluated in clinical trials. Concerns have been raised about the risk of bias in BMS trials, the reliability of claims that arise from such trials, and the potential for BMS trials to undermine breastfeeding in trial participants. Existing clinical trial guidance does not fully address issues specific to BMS trials. Objectives: To establish new methodological criteria to guide the design, conduct, analysis, and reporting of BMS trials and to support clinical trialists designing and undertaking BMS trials, editors and peer reviewers assessing trial reports for publication, and regulators evaluating the safety, nutritional adequacy, and efficacy of BMS products. Design, Setting, and Participants: A modified Delphi method was conducted, involving 3 rounds of anonymous questionnaires and a face-to-face consensus meeting between January 1 and October 24, 2018. Participants were 23 experts in BMS trials, BMS regulation, trial methods, breastfeeding support, infant feeding research, and medical publishing, and were affiliated with institutions across Europe, North America, and Australasia. Guidance development was supported by an industry consultation, analysis of methodological issues in a sample of published BMS trials, and consultations with BMS trial participants and a research ethics committee. Results: An initial 73 criteria, derived from the literature, were sent to the experts. The final consensus guidance contains 54 essential criteria and 4 recommended criteria. An 18-point checklist summarizes the criteria that are specific to BMS trials. Key themes emphasized in the guidance are research integrity and transparency of reporting, supporting breastfeeding in trial participants, accurate description of trial interventions, and use of valid and meaningful outcome measures. Conclusions and Relevance: Implementation of this guidance should enhance the quality and validity of BMS trials, protect BMS trial participants, and better inform the infant nutrition community about BMS products.

Evaluation of intervention reporting in published emergency medicine clinical trials.

OBJECTIVE: The extent of intervention reporting in emergency medicine journals remains unclear. The primary objective is to assess overall completion of the Template for Intervention Description and Replication (TIDieR) checklist described in emergency medicine randomized clinical trials (RCTs). The secondary outcomes were to (1) compare reporting before and after TIDieR publication; (2) evaluate factors associated with intervention reporting. METHODS: Our cross-sectional study used Google Scholar's metrics to identify seven emergency medicine journals; of which, we randomly sampled 300 articles. Using two PubMed searches, we extracted 150 RCTs before and after publications of TIDieR. Two investigators independently extracted data. The primary analysis to measure overall completion included descriptive statistics for each checklist item. Our secondary analysis used an interrupted time series analysis and generalized estimating equations to determine the effect of TIDieR publication on intervention reporting. RESULTS: Our initial search yielded 635 articles; from which, we randomly sampled 300 articles. We excluded 67 articles, leaving 233 for analysis. The mean number of TIDieR items reported was 5.4 (standard deviation = 1.18). Of the 233 trials, 42.9% provided information about materials, 67% provided intervention procedures, and 99.1% provided intervention delivery. The least reported items were intervention modifications (2.6%), intervention adherence assessment methods (3.4%), and intervention adherence assessment outcomes (2.2%). CONCLUSIONS: The completeness of intervention reporting is suboptimal in emergency medicine journals, necessitating improvement. The current state of adherence could be improved through the combined efforts of journal editors, major editorial organizations, and authors.

A longitudinal item response model for Aberrant Behavior Checklist (ABC) data from children with autism.

This manuscript aims to present the first item response theory (IRT) model within a pharmacometric framework to characterize the longitudinal changes of Aberrant Behavior Checklist (ABC) data in children with autism. Data were obtained from 120 patients, which included 20,880 observations of the 58 items for up to three months. Observed scores for each ABC item were modeled as a function of the subject's disability. Longitudinal IRT models with five latent disability variables based on ABC subscales were used to describe the irritability, lethargy, stereotypic behavior, hyperactivity, and inappropriate speech over time. The IRT pharmacometric models could accurately describe the longitudinal changes of the patient's disability while estimating different time-course of disability for the subscales. For all subscales, model-estimated disability was reduced following initiation of therapy, most markedly for hyperactivity. The developed framework provides a description of ABC longitudinal data that can be a suitable alternative to traditional ABC data collected in autism clinical trials. IRT is a powerful tool with the ability to capture the heterogeneous nature of ABC, which results in more accurate analysis in comparison to traditional approaches.