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PURPOSE: The objective of the trial was to compare the regression rate of atypical endometrial hyperplasia (AEH) in patients treated with megestrol acetate (MA) vs. levonorgestrel-intrauterine device (LNG-IUS). We also aimed to assess the fertility and pregnancy outcomes in these patients. METHODS: The study was a phase II multi-centre randomised controlled trial on the use of MA compared to LNG-IUS in the treatment of AEH conducted from January 2020 to January 2024 in Singapore. Women who were diagnosed with AEH and between 21 and 40 years old were included. The patients were randomised to receive either MA (160 mg orally daily) or LNG-IUS. The primary outcomes assessed were the regression rates at 3 months, 6 months and 9 months of treatment. The secondary outcomes assessed were the side effects, patient acceptability and fertility outcomes. RESULTS: Thirty-six patients completed the trial. The overall regression rate was 88.9% by 9 months. There was no statistically significant difference in the 9-month complete regression rate between MA vs. LNG-IUS. There was also no significant difference in side effects and weight change between both arms. Nineteen patients were actively pursuing fertility after complete regression. There were 8 pregnancies achieved, with resultant 4 live births and 4 miscarriages. CONCLUSION: Our study confirms a high regression rate of AH with medical treatment. LNG-IUS is a non-inferior treatment compared to megestrol acetate. Successful pregnancy outcomes can be achieved after regression of AEH. Long-term studies of sufficient sample-size are needed to assess for fertility and pregnancy outcomes, risk of recurrence and long-term risk of malignancy. TRIAL REGISTRATION NUMBER: The study was registered with the Health Science Authority (HSA) (License No.: CTA1900087) on September 5, 2019: https://eservice.hsa.gov.sg/prism/ct_r/enquiry.do?action=loadSpecificDetail . The trial was registered retrospectively on ClinicalTrials.gov (ID: NCT05492487) on April 7, 2022: https://clinicaltrials.gov/study/NCT05492487 .
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INTRODUCTION: Clear communication around surgical device use is crucial to patient safety. We evaluated the utility of the Device Briefing Tool (DBT) as an adjunct to the Surgical Safety Checklist. METHODS: A nonrandomized, controlled pilot of the DBT was conducted with surgical teams at an academic referral center. Intervention departments used the DBT in all cases involving a surgical device for 10 wk. Utility, relative advantage, and implementation effectiveness were evaluated via surveys. Trained observers assessed adherence and team performance using the Oxford NOTECHS system. RESULTS: Of 113 individuals surveyed, 91 responded. Most respondents rated the DBT as moderately to extremely useful. Utility was greatest for complex devices (89%) and new devices (88%). Advantages included insight into the team's familiarity with devices (70%) and improved teamwork and communication (68%). Users found it unrealistic to review all device instructional materials (54%). Free text responses suggested that the DBT heightened awareness of deficiencies in device familiarity and training but lacked a clear mechanism to correct them. DBT adherence was 82%. NOTECHS scores in intervention departments improved over the course of the study but did not significantly differ from comparator departments. CONCLUSIONS: The DBT was rated highly by both surgeons and nurses. Adherence was high and we found no evidence of "checklist fatigue." Centers interested in implementing the DBT should focus on devices that are complex or new to any surgical team member. Guidance for correcting deficiencies identified by the DBT will be provided in future iterations of the tool.
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Quirófanos , Cirujanos , Humanos , Lista de Verificación , Seguridad del Paciente , Comunicación , Grupo de Atención al PacienteRESUMEN
BACKGROUND: Pregnant women are at increased risk of influenza-related complications. The World Health Organisation recommends influenza vaccination to this high-risk population as highest priority. However, achieving high influenza vaccine coverage among pregnant women remains challenging. We conducted a cross-sectional survey to estimate the coverage and determinants of influenza vaccination among pregnant women in Singapore. METHODS: Between September and November 2017, pregnant women aged ≥21 years were recruited at two public hospitals in Singapore. Participants completed an anonymous, self-administered online questionnaire assessing participants' influenza vaccination uptake, knowledge of and attitudes towards influenza and the influenza vaccine, vaccination history, willingness to pay for the influenza vaccine, and external cues to vaccination. We estimated vaccine coverage and used multivariable Poisson models to identify factors associated with vaccine uptake. RESULTS: Response rate was 61% (500/814). Only 49 women (9.8, 95% Confidence Interval (CI): 7.3-12.7%) reported receiving the vaccine during their current pregnancy. A few misconceptions were identified among participants, such as the belief that influenza can be treated with antibiotics. The most frequent reason for not being vaccinated was lack of recommendation. Women who were personally advised to get vaccinated against influenza during pregnancy were 7 times more likely to be vaccinated (prevalence ratio (PR) = 7.11; 95% CI: 3.92-12.90). However, only 12% of women were personally advised to get vaccinated. Other factors associated with vaccine uptake were vaccination during a previous pregnancy (PR = 2.51; 95% CI: 1.54-4.11), having insurance to cover the cost of the vaccine (PR = 2.32; 95% CI: 1.43-3.76), and higher vaccine confidence (PR = 1.62; 95% CI: 1.30-2.01). CONCLUSIONS: Influenza vaccination uptake among pregnant women in Singapore is low. There is considerable scope for improving vaccination coverage in this high-risk population through vaccination recommendations from healthcare professionals, and public communication targeting common misconceptions about influenza and influenza vaccines.
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Vacunas contra la Influenza/administración & dosificación , Gripe Humana/prevención & control , Complicaciones Infecciosas del Embarazo/prevención & control , Mujeres Embarazadas/psicología , Cobertura de Vacunación/estadística & datos numéricos , Adulto , Estudios Transversales , Femenino , Conocimientos, Actitudes y Práctica en Salud , Hospitales Públicos , Humanos , Persona de Mediana Edad , Embarazo , Medición de Riesgo , Singapur , Encuestas y Cuestionarios , Adulto JovenRESUMEN
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.
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Lista de Verificación , Quirófanos , Humanos , Lista de Verificación/métodos , Estudios Prospectivos , Seguridad del Paciente , Hospitales , Grupo de Atención al PacienteRESUMEN
BACKGROUND: The World Health Organization Surgical Safety Checklist (SSC) is a tool designed to enhance team communication and patient safety. When used properly, the SSC acts as a layer of defence against never events. In this study, we performed secondary qualitative analysis of operating theatres (OT) SSC observational notes to examine how the SSC was used after an intensive SSC re-implementation effort and drew on relevant theories to shed light on the observed patterns of behaviours. We aimed to go beyond assessing checklist compliance and to understand potential sociopsychological mechanisms of the variations in SSC practices. METHODS: Direct observation notes of 109 surgical procedures across 13 surgical disciplines were made by two trained nurses in the OT of a large tertiary hospital in Singapore from February to April 2022, three months after SSC re-implementation. Only notes relevant to the use of SSC were extracted and analyzed using reflexive thematic analysis. Data were coded following an inductive process to identify themes or patterns of SSC practices. These patterns were subsequently interpreted against a relevant theory to appreciate the potential sociopsychological forces behind them. RESULTS: Two broad types of SSC practices and their respective sub-themes were identified. Type 1 (vs. Type 2) SSC practices are characterized by patience and thoroughness (vs. hurriedness and omission) in carrying out the SSC process, dedication and attention (vs. delegation and distraction) to the SSC safety checks, and frequent (vs. absence of) safety voices during the conduct of SSC. These patterns were conceptualized as safety-seeking action vs. ritualistic action using Merton's social deviance theory. CONCLUSION: Ritualistic practice of the SSC can undermine surgical safety by creating conditions conducive to never events. To fully realize the SSC's potential as an essential tool for communication and safety, a concerted effort is needed to balance thoroughness with efficiency. Additionally, fostering a culture of collaboration and collegiality is crucial to reinforce and enhance the culture of surgical safety.
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Lista de Verificación , Quirófanos , Humanos , Investigación Cualitativa , Seguridad del Paciente , Errores MédicosRESUMEN
Research question: To assess the levels of seminal biomarkers fructose, zinc and citrate and their correlations to semen parameters in infertile men. Design: 200 infertile male participants undergoing fertility assessment at Singapore General Hospital (SGH), Singapore were recruited prospectively, from June 2020 to August 2021. Their semen samples were assessed for seminal parameters, biomarker levels of fructose, citrate and zinc, leukocyte concentrations and aerobic cultures. They were also assessed for their smoking habits. Results: Sperm concentrations were negatively correlated to seminal fructose levels, r = -0.262, P < 0.001. Progressive motility were positively correlated to seminal citrate levels, r = 0.181, P = 0.014. Sperm morphology and total motile sperm count (TMSC) were positively correlated to seminal zinc and citrate levels, P < 0.05. Zinc and citrate levels were significantly reduced in teratozoospermia, asthenoteratozoospermia and oligoasthenoteratozoospermia groups compared to normozoospermia, P < 0.05. The presence of infection was associated with elevated leukocyte concentrations, lower sperm concentration (12.5 vs 55.8 million/mL, P = 0.024) and fructose levels (35.5 vs 49.2 µmol/ejaculate). Heavy smokers compared to light smokers, had lower sperm concentrations (35.3 vs 49.4 million/mL), TMSC (30.9 vs 47.5 million) and zinc levels (4.9 vs 6.7 µmol/ejaculate) and significantly lower citrate levels (52.6 vs 79.2 µmol/ejaculate, P = 0.029). Conclusions: Higher zinc and citrate levels correlated with better progressive motility, sperm morphology and TMSC. Smoking negatively impacted zinc and citrate levels, thereby affecting sperm quality. In conclusion, the inclusion of biomarkers in basic male work-up assessment would assist in identifying common deficiencies and aid in adequate replacement therapy.
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RATIONALE, AIMS, AND OBJECTIVES: The WHO Surgical Safety Checklist is a communication tool designed to improve surgical safety processes and enhance teamwork. It has been widely adopted since its introduction over ten years ago. As surgical safety needs evolve, organizations should periodically review and update their checklists. A holistic evaluation of the checklist in the context of an organization is the first step to making informed updates. In this article, we describe a comprehensive but feasible strategy for checklist evaluation which we developed and implemented as part of a surgical safety initiative in a high-performing center. METHODS: A three-part evaluation plan was developed and carried out by a multidisciplinary team. The evaluation included assessment of 1. Quality of care through a review of surgical safety events; 2. Safety culture through a validated survey and informal feedback; and 3. Checklist performance through direct observations and a staff survey. To prepare for re-implementation the current institutional checklist was critically evaluated and a context assessment survey was administered to surgical staff. RESULTS: The evaluation revealed challenges in communication and teamwork, with surgical staff often perceived to be working in silos. The quality of care assessment indicated room for improvement in safety processes. Deficiencies in the safety culture measures of communication and feedback shed light on an overall lack of engagement with the checklist. Checklist performance demonstrated good adherence to the items on the checklist but limited engagement by the surgical team and minimal communication between subteams. These findings informed our revisions to the checklist and its implementation processes. CONCLUSIONS: We developed and implemented a comprehensive, scalable approach to checklist evaluation which directly informed improvements to the checklist that were tailored to the organization's current context. Organizations can apply this framework to breathe new life into their checklist and transform their safety culture.
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Lista de Verificación , Seguridad del Paciente , Humanos , Quirófanos , Comunicación , Encuestas y CuestionariosRESUMEN
BACKGROUND: Interruptions in operative flow are known to increase team stress and errors in the operating room. Device-related interruptions are an increasing area of focus for surgical safety, but common safety processes such as the Surgical Safety Checklist do not adequately address surgical devices. We assessed the impact of the Device Briefing Tool, a communication instrument for surgical teams, on device-related interruptions in a large academic referral center in Singapore. METHODS: The Device Briefing Tool was implemented in 4 general surgery departments, with 4 additional departments serving as a comparator group. Trained observers evaluated device-related interruption incidence in live operations at baseline and after implementation. Changes in device-related interruption frequency were assessed in each group using Poisson regression, with and without adjustment for surgical department and device complexity. Subgroup analyses assessed the impact of the Device Briefing Tool by device type. RESULTS: A total of 210 operations were evaluated by observers. In the Device Briefing Tool group, there were 38.6 and 27.2 device-related interruptions per 100 cases at baseline and after Device Briefing Tool implementation, respectively (difference -23%, P = .0047, adjusted difference -28%, P = .0013). Device-related interruption frequency in the comparator group remained stable across study periods. Point estimates indicated reductions in device-related interruptions for all device types, reaching statistical significance for circular staplers (-26%, P = .0049). CONCLUSION: Implementation of the Device Briefing Tool was associated with a 28% reduction in device-related interruptions. Proactive approaches to improving surgical device safety are crucial in the technology-driven landscape of modern surgical care. Future efforts will assess formal integration of the Device Briefing Tool into institution-wide surgical safety processes.
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Quirófanos , Instrumentos Quirúrgicos , Humanos , Proyectos Piloto , Recolección de Datos , ComunicaciónRESUMEN
BACKGROUND: Non-technical skills are critical to surgical safety. We examined the impact of the COVID-19 pandemic on non-technical skills of operating room (OR) teams in Singapore. MATERIALS AND METHODS: Observers rated live operations using the Oxford NOTECHS system. Pre- and post-COVID observations were captured from November 2019 to January 2020 and from January 2021 to February 2021, respectively. Scores were compared using Schuirmann's Two One-Sided Test procedure. Multivariable linear regression was used to adjust for case mix. A 10% margin of equivalence was set a priori. RESULTS: Observers rated 159 cases: 75 pre-COVID and 84 post-COVID. There were significant differences between groups in surgical department and surgeon-reported case complexity (both P < 0.001). Total NOTECHS scores increased post-COVID on raw analysis (36.1 vs 38.0, P < 0.001) but remained within the margin of equivalence (90% CI 1.3 to 2.6, P < 0.001). Multivariable analysis demonstrated a similar increase within the margin of equivalence (2.0, 90% CI 1.3 to 2.7). Teamwork and cooperation scores increased by 1.0 post-COVID (90% CI 0.8 to 1.3); all other subcomponent scores were equivalent. CONCLUSION: Non-technical skills before and after the peak of the COVID-19 pandemic were equivalent but not equal. A small but statistically significant improvement post-COVID was driven by an increase in teamwork and cooperation skills. These findings may reflect an improvement in team cohesion, which has been observed in teams under duress in other settings such as the military. Future work should explore the effect of the pandemic on OR culture, team cohesion, and resilience.
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COVID-19 , Competencia Clínica , Humanos , Pandemias , Grupo de Atención al Paciente , SARS-CoV-2RESUMEN
BACKGROUND: Surgical devices are implicated in approximately 15% of intraoperative interruptions and 25% of errors. Device-related interruptions (DRIs) are therefore an important target for surgical quality improvement, but scalable measurement methodologies are lacking. The researchers therefore developed, pilot tested, and refined a simple tool for assessing intraoperative DRIs. METHODS: Five DRI categories achieved face validity with frontline providers and surgical safety experts: improper/challenging assembly, device failure, loss of sterility, disconnection, and absent/wrong device. A data collection tool was created based on these categories as well as a free-text section to capture emergent DRI categories. After a brief training session, the tool was pilot tested by observers at a large academic referral center. RESULTS: In a sample of 210 operations, observers noted 66 DRIs across 39 cases. DRIs were most common in colorectal (38.0 per 100 cases), gynecologic (33.3 per 100 cases), and hepatopancreatobiliary surgery (32.1 per 100 cases). Device failure accounted for 30.3% of observed DRIs. Three emergent categories were identified: user unfamiliarity with the device (15.2%), video display malfunction (4.5%), and physical breakage of the device (1.5%). CONCLUSION: Measurement of DRIs by novice observers is a feasible and scalable approach to support quality improvement efforts focusing on surgical devices. This approach could provide actionable insights to improve device safety, such as informing educational and training programs, optimizing surgical tray composition, and improving the physical layout of the operating room.
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Quirófanos , Mejoramiento de la Calidad , Femenino , HumanosRESUMEN
OBJECTIVES: The COVID-19 pandemic has forced a creative transition to virtual platforms due to physical distancing and travel restrictions. We designed and tested a highly scalable virtual training curriculum for novice raters using the Oxford NOTECHS non-technical skills rating system. DESIGN: A three-day training course comprising virtual didactics, virtually facilitated simulations, and independent live observations was implemented. NOTECHS scores were submitted for eleven standardized video simulations and four live operations. Intraclass correlation coefficients (ICCs) were calculated for total NOTECHS scores and subcomponent scores. Raters previously trained in-person with the same standardized videos served as a comparator group for equivalence testing. SETTING: All study activities were conducted in a large academic tertiary referral center in Singapore as part of an ongoing surgical safety initiative. PARTICIPANTS: Seven staff members underwent training (three virtually and four in-person). None had prior surgical experience or non-technical skills assessment training. RESULTS: ICCs for total NOTECHS scores were 0.85 (95% CI, 0.73-0.98) for virtually trained raters and 0.83 for those trained in-person (95% CI, 0.68-0.99). Scores were equivalent between groups within a 10% margin. CONCLUSIONS: Non-technical skills assessment can be reliably taught in a highly scalable virtual format. Virtual NOTECHS training is a valuable tool for educational and quality improvement initiatives during the COVID-19 pandemic and for centers that lack ready access to onsite non-technical skills training expertise.
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COVID-19 , Pandemias , Competencia Clínica , Curriculum , Humanos , SARS-CoV-2RESUMEN
SUMMARY: Gestational hypertriglyceridemia-induced pancreatitis is associated with significant maternal and fetal morbidity and mortality. We report a case of gestational hypertriglyceridemia-induced pancreatitis in a primigravida at 31-weeks gestation, complicated by impending preterm labor and metabolic acidosis requiring hemodialysis. This was successfully managed with therapeutic plasma exchange (TPE), followed by i.v. insulin, low-fat diet, and omega-3. Triglyceride levels stabilized after TPE and the patient underwent an uncomplicated term delivery. In pregnancy, elevated estrogen and insulin resistance exacerbate hypertriglyceridemia. Management is challenging as risks and benefits of treatment options need to be weighed against fetal wellbeing. We discuss management options including a review of previous case reports detailing TPE use, dietary optimization, and delivery timing. This case emphasizes the importance of multidisciplinary care to optimize maternal and fetal outcomes. LEARNING POINTS: Gestational hypertriglyceridemia-induced pancreatitis has high morbidity. A multidisciplinary team approach is a key as maternal and fetal needs must be addressed. Rapid lowering of triglycerides is crucial and can be achieved successfully and safely with plasma exchange. A low-fat diet while ensuring adequate nutrition in pregnancy is important. Timing of delivery requires consideration of fetal maturity and risk of recurrent pancreatitis.
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INTRODUCTION: Pathologically adherent placentas occur when there is a defect of the decidua basalis, typically arising from previous caesarean section, resulting in abnormally invasive implantation of the placenta. The depth of placental invasion varies from the superficial (accreta), to transmural and possibly beyond (percreta). CLINICAL PICTURE: We report on 2 cases, one treated "conservatively", the other with a caesarean hysterectomy, both of which led to a safe outcome for both mother and baby. CONCLUSIONS: Management relies on accurate early diagnosis with appropriate perioperative multidisciplinary planning to anticipate and avoid massive obstetric haemorrhage at delivery.
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Cesárea/efectos adversos , Placenta Accreta/diagnóstico , Hemorragia Uterina/etiología , Adulto , Cesárea/estadística & datos numéricos , Decidua/anomalías , Femenino , Humanos , Histerectomía , Incidencia , Imagen por Resonancia Magnética , Placenta/anomalías , Placenta/diagnóstico por imagen , Placenta Accreta/epidemiología , Placenta Accreta/etiología , Placenta Accreta/fisiopatología , Embarazo , Tailandia/epidemiología , UltrasonografíaAsunto(s)
Actitud del Personal de Salud , Lactancia Materna/ética , Salud Infantil/ética , Promoción de la Salud/ética , Salud del Lactante/ética , Pautas de la Práctica en Medicina/ética , Lactancia Materna/estadística & datos numéricos , Niño , Preescolar , Femenino , Salud Global/ética , Conocimientos, Actitudes y Práctica en Salud , Humanos , Lactante , Recién Nacido , SingapurRESUMEN
We present a case series of four patients with Caesarean scar pregnancies (CSPs) managed at our gynaecological unit between October 2008 and May 2009. Three patients were detected while asymptomatic, and were treated with elective intragestational sac methotrexate injections. The last patient had presented following complications from a termination of pregnancy for a CSP that was misdiagnosed as intrauterine. Following treatment, this patient and another developed arteriovenous malformation, which responded to bilateral uterine artery embolisations and gonadotropin releasing hormone (GnRH)-agonist treatment.