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Methods | ANASTOMOTIC LEAK | Surgical units were recruited and randomised in batches to receive a hospital-level education intervention designed to reduce anastomotic leak, either before, during, or following data collection. All consecutive patients undergoing right colectomy were included. Online learning, patient risk stratification and an in-t... | PMC10184073 | |
Results | The batched trial design allowed sequential entry of clusters, targeted research training and proved to be robust to pandemic interruptions. Staggered start times in the incomplete stepped wedge design with long lead-in times can reduce motivation and engagement and require careful administration. | PMC10184073 | ||
Conclusion | EAGLE’s robust but flexible study design allowed completion of the study across globally distributed geographical locations in spite of the pandemic. The primary outcome analysed in conjunction with the process evaluation will ensure a rich understanding of the intervention and the effects of the study design. | PMC10184073 | ||
Trial registration
| National Institute of Health Research Clinical Research Network portfolio IRAS ID: 272,250. Health Research Authority approval 18 October 2019. ClinicalTrials.gov, identifier NCT04270721, protocol ID RG_19196. | PMC10184073 | ||
Keywords | PMC10184073 | |||
Background
| anastomotic leak, colorectal surgery | ANASTOMOTIC LEAK, COMPLICATION | Improvement of surgical safety is a global healthcare priority with significant potential to reduce morbidity and mortality. The most important complication of colorectal surgery is anastomotic leak [Previous research has shown that specific risk factors that may be identified pre- and intra-operatively increase the ri... | PMC10184073 |
Methods | PMC10184073 | |||
Summary of the EAGLE trial | ANASTOMOTIC LEAK | Any surgical units that routinely perform both elective and emergency right colectomy in adult patients were eligible to enrol on the study. A surgical consultant, surgical trainee, an anaesthetist and a nurse principle investigator were required as a minimum in each local team (cluster). The primary objective was to r... | PMC10184073 | |
Choosing elements for quality improvement | colorectal surgeon [ | ANASTOMOTIC LEAK | EAGLE was tailored specifically to tackle differences identified in patient outcomes and improve overall anastomotic leak rate. Previous research including European Society of Coloproctology (ESCP) prospective audits demonstrated patient characteristics and intra-operative factors that increased the likelihood of anast... | PMC10184073 |
Selecting outcomes | The EAGLE study deliberately selected routinely collected data that would be simple to locate for any colorectal patient in any hospital regardless of geography or socio-economic situation. This promotes a high level of data completeness and reduces missing data. Full details of data collection and the case report form... | PMC10184073 | ||
Collaborative networks | The ESCP’s programme of snapshot audits (multicentre prospective audits to generate large datasets about colorectal surgery and its outcomes) [ | PMC10184073 | ||
Batched stepped wedge design | RECRUITMENT | Large clinical trials are notoriously complex to deliver and can have prolonged timelines. Surgical researchers are increasingly interested in methodological developments in randomised trials [The EAGLE protocol suggested indicatively that 7 batches of around 48 clusters each might be run, but the design and approach t... | PMC10184073 | |
Statistical efficiency | ANASTOMOTIC LEAK | An incomplete stepped wedge design was chosen in order to improve statistical efficiency by reducing both the number of clusters and the burden of individual-level data collection over all clusters necessary to achieve the required power [The EAGLE trial was designed to detect what was judged to be a clinically importa... | PMC10184073 | |
Flexibility for clusters and participants | The EAGLE protocol and resource packs offered a flexible approach to data collection to respect differences in local practice, with hard copy or electronic case report forms and the option for contemporaneous or retrospective database data entry. Password-protected e-modules were available throughout a four-week interv... | PMC10184073 | ||
Language | EAGLE’s global invitation introduced some challenges for the Central Operations Committee to ensure relevant resources were accessible to all participants. Theatre team presentations and the ESCP Safe Anastomosis Checklist were translated to thirteen languages (independently and checked by national coordinators) and ho... | PMC10184073 | ||
Case ascertainment and data accuracy | Data validation was addressed with two main strategies. Stepped wedge cluster randomised trials demand a particularly rigorous approach to case ascertainment [ | PMC10184073 | ||
Trial steering committee and data monitoring committee | TSC | EAGLE constituted a Trial Steering Committee (TSC) and Data Monitoring Committee (DMC) to provide ongoing oversight and independent decision-making in response to challenges. The DMC had access to unblinded, interim data summaries from wholly and partially completed batches of the trial, and their remit included monito... | PMC10184073 | |
Results | In the following sections, we reflect further on the evolution of the trial processes as the trial unfolded. | PMC10184073 | ||
Effects of and resilience to COVID-19 | EAGLE recruited and randomised the first batch of hospitals in December 2019, as ‘phase 1’, and the second in February 2020, ‘phase 2’, prior to the start of the COVID-19 pandemic. The pandemic rapidly shut down global surgical services and a decision was made to suspend the EAGLE study, just five weeks after launch, o... | PMC10184073 | ||
Team structure | The EAGLE team comprised separate Protocol Writing and Education Committee groups to drive forward the study design and the educational resources independently. The Operations Committee was convened to deliver the study with ‘Meta-coordinators’ liaising between the central team and ‘Coordinators’ who were responsible f... | PMC10184073 | ||
Discussion | PMC10184073 | |||
Trial strengths | EAGLE has proved a highly effective study design to deliver a complex quality improvement intervention in a wide range of settings across multiple study batches. Translation of resources and batching of clusters has enabled the study to navigate geographic, language and varied pandemic landscapes. The streamlined outco... | PMC10184073 | ||
Limitations | STAGGERED | Implementing the design in batches had a number of practical benefits [The staggered start dates for data collection and introduction of the intervention meant that collaborators, e.g. Surgical Trainee Principal Investigators could miss participating in the study itself despite garnering the appropriate approvals, beca... | PMC10184073 | |
Process evaluation | To ensure EAGLE’s results can be understood, a prospectively designed process evaluation is being undertaken. The parallel process evaluation will demonstrate how the education resources have reached learners (engagement), to what extent patients have received, or been exposed to, the EAGLE Safe Anastomosis Programme i... | PMC10184073 | ||
Conclusion | RECRUITMENT | EAGLE’s robust but flexible trial design allowed sequential recruitment and completion of the study across geographical locations in spite of the pandemic. EAGLE’s collaborative group originating in the ESCP network, helped nurture strong working relationships with resource sharing to reduce duplication. The primary ou... | PMC10184073 | |
Acknowledgements | James Keatley, ESCP Project Manager (European Society of Coloproctology). | PMC10184073 | ||
Authors’ contributions | Conception, design and manuscript writing: MV, RH, CK. Intervention design: EAGLE protocol writing group and education committee. Final approval of manuscript and accountability: all authors. | PMC10184073 | ||
Funding | This paper received no direct funding. EAGLE is an investigator-initiated and investigator-led study. The overall funding for study conduct has been provided by the European Society of Coloproctology (ESCP). Ethicon provided an unrestricted educational grant to the ESCP, used to support development of the online educat... | PMC10184073 | ||
Availability of data and materials | Data sharing not applicable to this article as no datasets were generated or analysed during the current manuscript. | PMC10184073 | ||
Declarations | PMC10184073 | |||
Ethics approval and consent to participate | The EAGLE study was approved in the UK as research without patient level consent by the Health Research Authority; IRAS project ID 272250; protocol number RG_19-196; REC reference 19/HRA/5656. Outside the UK ethical approvals were attained as mandated by each participating country. | PMC10184073 | ||
Consent for publication | Not applicable. | PMC10184073 | ||
Competing interests | The authors declare that they have no competing interests and study sites were not paid for their contributions to the manuscript. | PMC10184073 | ||
References | PMC10184073 | |||
Background | Edited by: Grace Gachanja, Walden University, United StatesReviewed by: Patricia Garvie, Children's Diagnostic & Treatment Center, United States; Philippe Msellati, PACCI, Côte d'IvoireThe HADITHI study is a cluster-randomized trial of children living with HIV and their caregivers in Kenya that aimed to increase rates ... | PMC10196043 | ||
Methods | REGRESSION | A penalized logistic regression model with lasso regularization identified the most important predictors of disclosure. The two-stage least squares instrumental variable approach was used to assess outcomes accounting for non-compliance to disclosure. | PMC10196043 | |
Results | depression | Caregiver non-isolation and shorter time on antiretroviral therapy were predictive of HIV status disclosure. There were no statistically significant differences found in CD4 percentage, depression status, or mental and emotional status based on disclosure status up to 24 months-post intervention. | PMC10196043 | |
Conclusion | These findings have implications for specialists seeking to tailor disclosure interventions to improve caregiver-child dyad responsiveness. | PMC10196043 | ||
Introduction | HIV illness, infected with HIV globally, HIV disclosure | In 2021, there were approximately 1.7 million children living with HIV and 160,000 children newly infected with HIV globally (Despite the clear importance of disclosure for children living with HIV, most adolescents in resource-limited settings remain undisclosed. Up to 50% of adolescents across studies in low and midd... | PMC10196043 | |
Methods | PMC10196043 | |||
The HADITHI intervention for HIV disclosure | HIV disclosure | SECONDARY, HIV INFECTION | The Academic Model Providing Access to Healthcare (AMPATH) Consortium is a partnership established in 2001 between 14 universities and academic health centers across North America and Moi University and Moi Teaching and Referral Hospital in Eldoret, Kenya that aims to provide comprehensive and preventative care, advanc... | PMC10196043 |
Current study design | The overall objective of this | PMC10196043 | ||
Patient selection | Two hundred and eighty five caregiver-child dyads were recruited for the HADITHI trial from eight facilities in Eldoret, Kenya between June and August 2013. We restricted our analysis to children who were not disclosed to at baseline. Disclosure was defined as a binary variable (whether or not the child knew his/her HI... | PMC10196043 | ||
Measures | AIDS, depression, Depression | AIDS, PEDIATRIC AIDS | Disclosure post-intervention was defined as a binary variable of whether or not the child knew his/her HIV status as reported by both child and caregiver via disclosure questionnaires. Disclosure was assessed at 6-month intervals from baseline (immediately post-intervention) to 24 months post-intervention.Eighty demogr... | PMC10196043 |
Statistical analysis | Sample characteristics and distributions of categorical predictors were summarized using numbers and percentages for categorical variables, mean and standard deviation for normalized continuous variables, and median and interquartile ranges for non-normalized continuous variables. Baseline characteristics of children i... | PMC10196043 | ||
Caregiver compliance to disclosure | HIV, mental health, overall health | REGRESSION | The least absolute shrinkage and selection operator (LASSO) penalized regression was used to select the best subset of predictors of disclosure for the 60 caregiver-child dyads who were randomized into the intervention group. We defined disclosure as a binary response of “disclosed” vs. “not disclosed,” with disclosure... | PMC10196043 |
Local average treatment effect | REGRESSION | Instrumental variable (IV) methods were used to assess outcomes of children with HIV to account for non-compliance to disclosure among intervention participants (Causal diagram for intent-to-treat HADITHI intervention data analysis with comparison updated casual diagram for instrumental variable analysis isolating HADI... | PMC10196043 | |
Results | PMC10196043 | |||
Baseline demographic and clinical characteristics | SECONDARY | Of the 146 non-disclosed caregiver-child dyads who participated in the HADITHI intervention, 130 (89%) completed all follow-up assessments and were included in this secondary analysis.Among all non-disclosed participants, the median child age was 11.42 years old and 55% were girls (Baseline demographics and clinical ch... | PMC10196043 | |
Caregiver compliance to disclosure | REGRESSION | Ninety-one percent of caregiver-child dyads who participated in the HADITHI intervention completed follow-up disclosure questionnaires until 24 months post-intervention. Eighty clinical and demographic covariates collected from the 60 caregiver-child dyads who participated in the HADITHI intervention were entered into ... | PMC10196043 | |
Local average treatment effect on clinical HIV and mental and behavioral health outcomes | REGRESSION | IV regression was conducted to compare clinical outcomes between intervention participants who disclosed HIV status post-intervention and those who did not. There were no significant differences in CD4 count, PHQ-9 scores, or SDQ scores between the children of intervention compliers and non-compliers at 6 months, 12 mo... | PMC10196043 | |
Discussion | REGRESSION | This study defined caregiver-child characteristics that predicted caregiver compliance to a disclosure intervention for children living with HIV and their families in western Kenya. We also used instrumental variable methods to explore local average treatment effects of disclosure post-intervention on HIV, mental healt... | PMC10196043 | |
Conclusion | depression | Our study found that caregiver isolation status and the length of time a child had been on antiretroviral therapy were predictive of disclosure of HIV status to children living with HIV in western Kenya after participation in a disclosure intervention. We also found that children who had their HIV status disclosed to t... | PMC10196043 | |
Data availability statement | The original contributions presented in this study are included in the article/ | PMC10196043 | ||
Ethics statement | The studies involving human participants were reviewed and approved by Institutional Review Board at Indiana University School of Medicine in Indianapolis, Indiana, USA, and Institutional Research Ethics Committee at Moi University School of Medicine in Eldoret, Kenya. Written informed consent to participate in this st... | PMC10196043 | ||
Author contributions | EM, AB, and RV designed the research. WN, JA, CA, JL, TN, FS, JN, MS, and JH proved substantial contributions to the conception of the project and the acquisition of project data. EM completed data analysis and manuscript drafting. WN, AB, AC, and RV contributed to manuscript revision. All authors contributed to the ar... | PMC10196043 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10196043 | ||
Publisher's note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC10196043 | ||
Supplementary material | The Supplementary Material for this article can be found online at: Click here for additional data file. | PMC10196043 | ||
References | PMC10196043 | |||
Background | PONV, Postoperative nausea and vomiting | COMPLICATION | Postoperative nausea and vomiting (PONV) is a common but troublesome complication in patients who undergo laparoscopic bariatric surgery (LBS). Whether sugammadex use is related to the persistent decrease in the occurrence of PONV during postoperative inpatient hospitalization, which is critical for the rehabilitation ... | PMC10184386 |
Methods | PONV | REGRESSION, SECONDARY | The study was based on a randomized controlled trial conducted in an accredited bariatric centre. A total of 205 patients who underwent LBS were included in the analysis. Univariate analysis and multivariable logistic regression model were used to identify the significant variables related to PONV. Then propensity scor... | PMC10184386 |
Results | PONV | The incidence of PONV was 43.4% (89/205) within the first 48 h after LBS. In multivariable analysis, sugammadex use (OR 0.03, 95% CI 0.01–0.09, | PMC10184386 | |
Conclusions | PONV | Compared with neostigmine, sugammadex can reduce the incidence and severity of PONV, increase postoperative water intake, and shorten the time to first flatus in bariatric patients during postoperative inpatient hospitalization, which may play a pivotal role in enhanced recovery. | PMC10184386 | |
Trial registration | Chinese Clinical Trial Registry (ChiCTR2100052418, | PMC10184386 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12871-023-02123-y. | PMC10184386 | ||
Keywords | PMC10184386 | |||
Background | PONV, Postoperative nausea and vomiting | NEUROMUSCULAR BLOCKADE, COMPLICATION | Postoperative nausea and vomiting (PONV) is a common complication following general anesthesia and surgery, particularly in patients undergoing laparoscopic bariatric surgery (LBS), with a prevalence of up to 80% [Sugammadex, a modified γ-cyclodextrin, has been used clinically to reverse neuromuscular blockade (NMB) of... | PMC10184386 |
Methods | PMC10184386 | |||
Study design and data source | Data were retrieved from the database of our recently completed trial (named PHCBS; IRB #2020-SR-059; registered at
Flow chart of the study. | PMC10184386 | ||
Perioperative protocol | jejunojejunal bypass | The same surgeon performed all procedures including laparoscopic sleeve gastrectomy (LSG), laparoscopic sleeve gastrectomy plus duodenojejunal bypass (LSG-DJB), laparoscopic sleeve gastrectomy plus jejunojejunal bypass (LSG-JJB), and one-anastomosis gastric bypass (OAGB). All patients received standard anesthesia with ... | PMC10184386 | |
Outcome measures | nausea or vomiting, nausea, POV, vomiting, postoperative vomiting, vomiting, II, vomiting episodes, PONV, retching, nausea, vomiting | SECONDARY | The primary outcome was the incidence of PONV within 48 h after LBS. The secondary endpoints included the severity of PONV, time to first flatus, need for rescue antiemetic therapy, and water intake within 48 h after LBS. PONV was defined as at least one episode of nausea, vomiting, or retching. PONV was evaluated as f... | PMC10184386 |
Statistical analysis | PONV, nausea and vomiting | EVENT, DIABETES MELLITUS, REGRESSION, MOTION SICKNESS, HYPERTENSION | All analyses were performed using R software (version 4.2.0, R Foundation for Statistical Computing, Vienna, Austria) and IBM SPSS Statistics for Windows (version 21.0, SPSS Inc. Chicago, Illinois, USA). Statistical significance was defined by a two-sided Based on clinical importance, scientific knowledge, previous res... | PMC10184386 |
Discussion | PONV, neuromuscular paralysis | A cohort study involving 74 patients undergoing LBS indicated that 59% of the patients experienced PONV despite being treated with supra-optimal PONV prophylaxis [Bariatric surgery is a potential risk factor for PONV [Two points need to be further explained. First, neostigmine is a cholinesterase inhibitor commonly use... | PMC10184386 | |
Conclusions | PONV | In conclusion, compared with neostigmine, sugammadex can reduce the incidence and severity of PONV, increase postoperative water intake, and shorten the time to first flatus in bariatric patients during postoperative inpatient hospitalization, which may play a pivotal role in enhanced recovery. | PMC10184386 | |
Acknowledgements | We thank Prof. Honggang Yi (Department of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, China) for his statistical analysis assistance. We also would like to thank Editage ( | PMC10184386 | ||
Authors’ contributions | Xiahao Ding: data collection; methodology; formal analysis; writing—original draft; Xiaozhong Zhu: methodology; writing—original draft; Cuimei Zhao: methodology; formal analysis; Dapeng Chen: methodology; data collection; validation; Yuting Wang: data collection; Hui Liang: conceptualization; Bo Gui: conceptualization;... | PMC10184386 | ||
Funding | Not applicable. | PMC10184386 | ||
Data availability | The datasets generated and/or analyzed during the current study are not publicly available due to potential patient privacy compromise but are available from the corresponding author on reasonable request. | PMC10184386 | ||
Abbreviations | nausea, postoperative nausea and vomiting | American Society of AnesthesiologistsAbsolute standardized mean differenceBody mass indexConfidence intervalDuration of the anesthesiaDuration of the operationHistory of motion sicknessHistory of postoperative nausea and vomitingIntraoperative opioids consumptionInverse probability of treatment weightingLaparoscopic ba... | PMC10184386 | |
References | PMC10184386 | |||
Background | The need for digital literacy in aging populations is increasing in the digitalizing society. Digital literacy involves the identification, evaluation, and communication of information through various digital devices or relevant programs. | PMC10755654 | ||
Objective | The aims of this study were to develop an Everyday Digital Literacy Questionnaire (EDLQ), a digital literacy assessment scale, and subsequently evaluate its psychometric properties using a population of community-dwelling older adults in South Korea. | PMC10755654 | ||
Methods | The EDLQ was developed using an instrument development design. A nationwide survey was conducted, and the study included 1016 community-dwelling older adults (age ≥60 years). To evaluate the psychometric properties, the participants were randomly divided into 2 groups (n=508 each), and the internal consistency (Cronbac... | PMC10755654 | ||
Results | Among the initial 30 items of the EDLQ, 22 items with a 3-factor solution had a total explained variance of 77%. The domains included “information and communication” (9 items), “content creation and management” (4 items), and “safety and security” (9 items). Confirmatory factor analysis was conducted with this 3-factor... | PMC10755654 | ||
Conclusions | In this study, we developed a digital literacy measure with strong psychometric properties that made it suitable for assessing the digital literacy of community-dwelling older adults in Korea. To broaden its applicability, however, further assessment of its feasibility for use with different languages and cultures is n... | PMC10755654 | ||
Introduction | Advancements in digital technology have great potential for promoting healthy aging among older adults. Previous studies have reported the role of digital technology in preserving [The number of older adults using technology has increased gradually; however, a substantial difference persists between age groups in digit... | PMC10755654 | ||
Methods | In this study, the EDLQ was developed using the 4 phases of instrument development and validation (conceptualization, item development, content validation, and a field survey) to evaluate its psychometric properties. | PMC10755654 | ||
Ethical Considerations | In accordance with the Helsinki Declaration, all procedures in this study have been reviewed and approved by the Institutional Review Board of Yonsei University (approval 4-2022-0396). | PMC10755654 | ||
Phase I: Conceptualization | This step involved identifying the concept and scope of digital literacy using the DigComp framework comprising five domains: (1) information literacy, (2) communication and collaboration with others, (3) content creation and editing, (4) safety and security, and (5) problem-solving [ | PMC10755654 | ||
Phase II: Item Development | The development of the preliminary items involves multiple steps. First, we referred to the 25-item self-assessment grid from the European Commission that outlined the foundation level of digital literacy. This step was done to ensure the inclusion of relevant items aligned with the digital competence levels of older a... | PMC10755654 | ||
Phase III: Content Validation | We invited 7 external experts representing diverse disciplines, including health informatics, public health, medicine, sociology, social work, and measurements. The panel of multidisciplinary experts agreed to participate in content validation, and all of them were remunerated for their time. Each expert was asked to e... | PMC10755654 | ||
Phase IV: Field Survey | PMC10755654 | |||
Study Design | A cross-sectional survey was conducted to assess the validity of the EDLQ. This survey aimed to evaluate structural and hypothesis-testing construct validity, internal consistency, measurement invariance, and floor and ceiling effects. | PMC10755654 | ||
Sample and Data Collection | A total of 1016 participants were recruited nationwide from October to November 2022 using proportional stratified sampling based on region, sex, and age groups. The sampling procedure was designed to align with the registered population of South Korea in June 2022. The inclusion criteria for the sample were (1) indivi... | PMC10755654 | ||
Measures | The eHEALS, a validated measure of eHealth literacy, was used as a comparator instrument to assess the construct validity of the EDLQ using a hypothesis-testing approach. Based on the prior studies [ | PMC10755654 | ||
Data Analysis | The data were analyzed using SAS for Windows (version 9.4; SAS Institute Inc) and the To determine the suitability of subsample 1 data for EFA, the Kaiser-Meyer-Olkin (KMO) test of sampling adequacy and Bartlett test of sphericity were conducted. For factor analysis, a KMO index of at least 0.50 (ranging from 0 to 1) a... | PMC10755654 | ||
Results | PMC10755654 | |||
Generated Items | In our qualitative research assessing digital literacy among community-dwelling older adults, participants provided diverse feedback regarding their experiences with digital technologies. We collected data on their proficiency in information and data literacy, communication or collaboration, and problem-solving related... | PMC10755654 | ||
Content Validity | Content validation of the initial 35 items revealed that the S-CVI/AVE values for relevance and clarity were 0.94 and 0.84, respectively. All items met the relevance criterion (≥0.78) in terms of the I-CVI. Moreover, 26 of the 35 items fulfilled the criterion for item clarity (≥0.90). Items that did not meet the clarit... | PMC10755654 |
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