Hitting the target and missing the point? A BEME systematic review of evidence regarding the efficacy of statutory and mandatory training in health and care: BEME Guide No. 87.

BACKGROUND: Mandatory training is considered fundamental to establishing and maintaining high standards of professional practice. There is little evidence however, of the training either achieving its required learning outcomes, or delivering improvement in outcomes for patients. Whist organisations may be hitting their compliance target for mandatory training, is the purpose missing the point? This systematic review aims to synthesize and evaluate the efficacy of statutory and mandatory training. METHODS: PubMed, EMBASE, CNAHL, ERIC and Cochrane Central registers were searched on 23rd May 2023. All research designs were included and reported training had to specify an organisational mandate within a healthcare setting. Data was coded using a modified Kirkpatrick (KP) rating system. Critical appraisal was undertaken using the Modified Medical Education Research Study Quality Instrument, Critical Appraisal Skills Programme Qualitative Studies checklist and Mixed Methods Assessment Tool. RESULTS: Twenty-five studies were included, featuring 9132 participants and 1348 patient cases audited. Studies described evaluation of mandatory training according to Kirkpatrick's outcomes levels 1-4b, with the majority (68%) undertaken in the UK and within acute settings. Training duration varied from 5 min to 3 days. There is a lack of consensus regarding mandatory training rationale, core topics, duration, and optimum refresher training period. Currently, mandatory training does not consistently translate to widescale improvements in safe practice or improved patient outcomes. CONCLUSIONS: Due to the lack of international consensus regarding the need for mandated training, most papers originated from countries with centrally administered national health care systems. The rationale for mandating training programmes remains undefined. The assumption that mandatory training is delivering safe practice outcomes is not supported by studies included in this review. The findings of this review offer a basis for further research to be undertaken to assist with the design, facilitation, and impact of mandatory training.

Assessment of a SARS-CoV-2 wastewater monitoring program in El Paso, Texas, from November 2020 to June 2022.

The border city of El Paso, Texas, and its water utility, El Paso Water, initiated a SARS-CoV-2 wastewater monitoring program to assess virus trends and the appropriateness of a wastewater monitoring program for the community. Nearly weekly sample collection at four wastewater treatment facilities (WWTFs), serving distinct regions of the city, was analyzed for SARS-CoV-2 genes using the CDC 2019-Novel coronavirus Real-Time RT-PCR diagnostic panel. Virus concentrations ranged from 86.7 to 268,000 gc/L, varying across time and at each WWTF. The lag time between virus concentrations in wastewater and reported COVID-19 case rates (per 100,00 population) ranged from 4-24 days for the four WWTFs, with the strongest trend occurring from November 2021 - June 2022. This study is an assessment of the utility of a geographically refined SARS-CoV-2 wastewater monitoring program to supplement public health efforts that will manage the virus as it becomes endemic in El Paso.

Evaluation of the Incremental Value of a Coronary Artery Calcium Score Beyond Traditional Cardiovascular Risk Assessment: A Systematic Review and Meta-analysis.

Importance: Coronary artery calcium scores (CACS) are used to help assess patients' cardiovascular status and risk. However, their best use in risk assessment beyond traditional cardiovascular factors in primary prevention is uncertain. Objective: To find, assess, and synthesize all cohort studies that assessed the incremental gain from the addition of a CACS to a standard cardiovascular disease (CVD) risk calculator (or CVD risk factors for a standard calculator), that is, comparing CVD risk score plus CACS with CVD risk score alone. Evidence Review: Eligible studies needed to be cohort studies in primary prevention populations that used 1 of the CVD risk calculators recommended by national guidelines (Framingham Risk Score, QRISK, pooled cohort equation, NZ PREDICT, NORRISK, or SCORE) and assessed and reported incremental discrimination with CACS for estimating the risk of a future cardiovascular event. Findings: From 2772 records screened, 6 eligible cohort studies were identified (with 1043 CVD events in 17 961 unique participants) from the US (n = 3), the Netherlands (n = 1), Germany (n = 1), and South Korea (n = 1). Studies varied in size from 470 to 5185 participants (range of mean [SD] ages, 50 [10] to 75.1 [7.3] years; 38.4%-59.4% were women). The C statistic for the CVD risk models without CACS ranged from 0.693 (95% CI, 0.661-0.726) to 0.80. The pooled gain in C statistic from adding CACS was 0.036 (95% CI, 0.020-0.052). Among participants classified as being at low risk by the risk score and reclassified as at intermediate or high risk by CACS, 85.5% (65 of 76) to 96.4% (349 of 362) did not have a CVD event during follow-up (range, 5.1-10.0 years). Among participants classified as being at high risk by the risk score and reclassified as being at low risk by CACS, 91.4% (202 of 221) to 99.2% (502 of 506) did not have a CVD event during follow-up. Conclusions and Relevance: This systematic review and meta-analysis found that the CACS appears to add some further discrimination to the traditional CVD risk assessment equations used in these studies, which appears to be relatively consistent across studies. However, the modest gain may often be outweighed by costs, rates of incidental findings, and radiation risks. Although the CACS may have a role for refining risk assessment in selected patients, which patients would benefit remains unclear. At present, no evidence suggests that adding CACS to traditional risk scores provides clinical benefit.

Time Above All Else: Pharmacodynamic Analysis of ß-Lactams in Critically Ill Patients.

ß-Lactams are the most commonly used antibiotics in intensive care units (ICUs). As critically ill patients often experience pharmacokinetic aberrations, and rates of antimicrobial resistance vary between hospital settings, reliance on tertiary sources or package labeling to guide empiric dosing often results in suboptimal ß-lactam exposure. The primary objective was to identify ß-lactam regimens capable of achieving ≥90% cumulative fraction of response (CFR) against 7 Gram-negative pathogens within 4 ICUs at our institution. Unit-specific minimal inhibitory concentration (MIC) distribution data was used in combination with published pharmacokinetic parameters in critically ill patients to perform Monte Carlo simulations. The percentage of time for which the unbound concentration of antibiotic remained above the MIC (%ƒT > MIC) was used as the pharmacodynamic target: 70%ƒT >MIC for cefepime, 40%ƒT > MIC for meropenem, and 50%ƒT > MIC for piperacillin/tazobactam. Regimens were modeled to determine the likelihood of achieving ≥90% CFR. Overall, intermittently dosed cefepime, meropenem, and piperacillin/tazobactam failed to achieve ≥90% CFR for every organism. Cefepime 2 g intermittent bolus every 8 hours failed to achieve ≥90% CFR for Klebsiella pneumoniae or Enterobacter cloacae despite susceptibility rates exceeding 90%. Piperacillin/tazobactam 4.5 g prolonged infusion (PI) every 6 hours achieved <85% CFR for Pseudomonas aeruginosa and <50% CFR for Acinetobacter baumannii in every ICU. Meropenem 2 g PI every 8 hours and meropenem 2 g PI every 6 hours were the only regimens capable of achieving ≥90% CFR for P aeruginosa in all units. Use of Monte Carlo simulations, with incorporation of local MIC distribution data, provides a mechanism to effectively predict optimal agent and dose selection within specific hospital systems, thereby enhancing pharmacokinetic/pharmacodynamic optimization and improving clinical efficacy.

A catalogue of tools and variables from crisis and routine care to support decision-making about allocation of intensive care beds and ventilator treatment during pandemics: Scoping review.

PURPOSE: This scoping review sought to identify objective factors to assist clinicians and policy-makers in making consistent, objective and ethically sound decisions about resource allocation when healthcare rationing is inevitable. MATERIALS AND METHODS: Review of guidelines and tools used in ICUs, hospital wards and emergency departments on how to best allocate intensive care beds and ventilators either during routine care or developed during previous epidemics, and association with patient outcomes during and after hospitalisation. RESULTS: Eighty publications from 20 countries reporting accuracy or validity of prognostic tools/algorithms, or significant correlation between prognostic variables and clinical outcomes met our eligibility criteria: twelve pandemic guidelines/triage protocols/consensus statements, twenty-two pandemic algorithms, and 46 prognostic tools/variables from non-crisis situations. Prognostic indicators presented here can be combined to create locally-relevant triage algorithms for clinicians and policy makers deciding about allocation of ICU beds and ventilators during a pandemic. No consensus was found on the ethical issues to incorporate in the decision to admit or triage out of intensive care. CONCLUSIONS: This review provides a unique reference intended as a discussion starter for clinicians and policy makers to consider formalising an objective a locally-relevant triage consensus document that enhances confidence in decision-making during healthcare rationing of critical care and ventilator resources.

Systematic review automation tools improve efficiency but lack of knowledge impedes their adoption: a survey.

OBJECTIVE: We investigated systematic review automation tool use by systematic reviewers, health technology assessors and clinical guideline developerst. STUDY DESIGN AND SETTING: An online, 16-question survey was distributed across several evidence synthesis, health technology assessment and guideline development organizations. We asked the respondents what tools they use and abandon, how often and when do they use the tools, their perceived time savings and accuracy, and desired new tools. Descriptive statistics were used to report the results. RESULTS: A total of 253 respondents completed the survey; 89% have used systematic review automation tools - most frequently whilst screening (79%). Respondents' "top 3" tools included: Covidence (45%), RevMan (35%), Rayyan and GRADEPro (both 22%); most commonly abandoned were Rayyan (19%), Covidence (15%), DistillerSR (14%) and RevMan (13%). Tools saved time (80%) and increased accuracy (54%). Respondents taught themselves to how to use the tools (72%); lack of knowledge was the most frequent barrier to tool adoption (51%). New tool development was suggested for the searching and data extraction stages. CONCLUSION: Automation tools will likely have an increasingly important role in high-quality and timely reviews. Further work is required in training and dissemination of automation tools and ensuring they meet the desirable features of those conducting systematic reviews.

The Impact of Systematic Review Automation Tools on Methodological Quality and Time Taken to Complete Systematic Review Tasks: Case Study.

BACKGROUND: Systematic reviews (SRs) are considered the highest level of evidence to answer research questions; however, they are time and resource intensive. OBJECTIVE: When comparing SR tasks done manually, using standard methods, versus those same SR tasks done using automated tools, (1) what is the difference in time to complete the SR task and (2) what is the impact on the error rate of the SR task? METHODS: A case study compared specific tasks done during the conduct of an SR on prebiotic, probiotic, and synbiotic supplementation in chronic kidney disease. Two participants (manual team) conducted the SR using current methods, comprising a total of 16 tasks. Another two participants (automation team) conducted the tasks where a systematic review automation (SRA) tool was available, comprising of a total of six tasks. The time taken and error rate of the six tasks that were completed by both teams were compared. RESULTS: The approximate time for the manual team to produce a draft of the background, methods, and results sections of the SR was 126 hours. For the six tasks in which times were compared, the manual team spent 2493 minutes (42 hours) on the tasks, compared to 708 minutes (12 hours) spent by the automation team. The manual team had a higher error rate in two of the six tasks-regarding Task 5: Run the systematic search, the manual team made eight errors versus three errors made by the automation team; regarding Task 12: Assess the risk of bias, 25 assessments differed from a reference standard for the manual team compared to 20 differences for the automation team. The manual team had a lower error rate in one of the six tasks-regarding Task 6: Deduplicate search results, the manual team removed one unique study and missed zero duplicates versus the automation team who removed two unique studies and missed seven duplicates. Error rates were similar for the two remaining compared tasks-regarding Task 7: Screen the titles and abstracts and Task 9: Screen the full text, zero relevant studies were excluded by both teams. One task could not be compared between groups-Task 8: Find the full text. CONCLUSIONS: For the majority of SR tasks where an SRA tool was used, the time required to complete that task was reduced for novice researchers while methodological quality was maintained.

The MethodologicAl STandards for Epidemiological Research (MASTER) scale demonstrated a unified framework for bias assessment.

OBJECTIVE: This paper presents a unified framework for assessment of the methodological quality of analytic study designs. STUDY DESIGN AND SETTING: A systematic review of 393 methodological quality assessment tools that updated a previous assessment with 100 tools. Tool items were extracted, examined and reworded. Bias domains and finally methodological standards to be fulfilled were defined. RESULTS: There were 36 unique methodological safeguards that were categorized into seven methodological standards to be fulfilled in the MASTER scale. These methodological standards reflect initial and ongoing equivalence in particular areas, including equal recruitment, equal retention, equal ascertainment, equal implementation, equal prognosis, sufficient analysis, and temporal precedence. CONCLUSION: This approach unifies existing methods for methodological quality assessment and will be useful for (1) clinical researchers when a bias assessment of clinical research studies is required across analytical designs, (2) promoting a unified framework for bias assessment.

Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial.

BACKGROUND: Heavy menstrual bleeding affects 25% of women in the UK, many of whom require surgery to treat it. Hysterectomy is effective but has more complications than endometrial ablation, which is less invasive but ultimately leads to hysterectomy in 20% of women. We compared laparoscopic supracervical hysterectomy with endometrial ablation in women seeking surgical treatment for heavy menstrual bleeding. METHODS: In this parallel-group, multicentre, open-label, randomised controlled trial in 31 hospitals in the UK, women younger than 50 years who were referred to a gynaecologist for surgical treatment of heavy menstrual bleeding and who were eligible for endometrial ablation were randomly allocated (1:1) to either laparoscopic supracervical hysterectomy or second generation endometrial ablation. Women were randomly assigned by either an interactive voice response telephone system or an internet-based application with a minimisation algorithm based on centre and age group (<40 years vs ≥40 years). Laparoscopic supracervical hysterectomy involves laparoscopic (keyhole) surgery to remove the upper part of the uterus (the body) containing the endometrium. Endometrial ablation aims to treat heavy menstrual bleeding by destroying the endometrium, which is responsible for heavy periods. The co-primary clinical outcomes were patient satisfaction and condition-specific quality of life, measured with the menorrhagia multi-attribute quality of life scale (MMAS), assessed at 15 months after randomisation. Our analysis was based on the intention-to-treat principle. The trial was registered with the ISRCTN registry, number ISRCTN49013893. FINDINGS: Between May 21, 2014, and March 28, 2017, we enrolled and randomly assigned 660 women (330 in each group). 616 (93%) of 660 women were operated on within the study period, 588 (95%) of whom received the allocated procedure and 28 (5%) of whom had an alternative surgery. At 15 months after randomisation, more women allocated to laparoscopic supracervical hysterectomy were satisfied with their operation compared with those in the endometrial ablation group (270 [97%] of 278 women vs 244 [87%] of 280 women; adjusted percentage difference 9·8, 95% CI 5·1-14·5; adjusted odds ratio [OR] 2·53, 95% CI 1·83-3·48; p<0·0001). Women randomly assigned to laparoscopic supracervical hysterectomy were also more likely to have the best possible MMAS score of 100 than women assigned to endometrial ablation (180 [69%] of 262 women vs 146 [54%] of 268 women; adjusted percentage difference 13·3, 95% CI 3·8-22·8; adjusted OR 1·87, 95% CI 1·31-2·67; p=0·00058). 14 (5%) of 309 women in the laparoscopic supracervical hysterectomy group and 11 (4%) of 307 women in the endometrial ablation group had at least one serious adverse event (adjusted OR 1·30, 95% CI 0·56-3·02; p=0·54). INTERPRETATION: Laparoscopic supracervical hysterectomy is superior to endometrial ablation in terms of clinical effectiveness and has a similar proportion of complications, but takes longer to perform and is associated with a longer recovery. FUNDING: UK National Institute for Health Research Health Technology Assessment Programme.

A unified framework for bias assessment in clinical research.

Methodological flaws, limitations, and inadequate practices in research are well known and pose threats to the internal validity of any research study. However, there are ways of safeguarding research conduct to reduce the chance of research producing distorted results. Numerous tools now exist to assess the incorporation of such safeguards into primary research studies (also known as quality and/or risk-of-bias assessment). These tools typically include a variety of items that are then checked against those implemented in the study. Despite a lot of research in this area, no comprehensive generic classification of safeguards across study designs exist, although attempts have been made to clarify aspects of this. We review the developments in this area as well as use preliminary data from 100 methodological studies to illustrate our proposed approach. We conclude by proposing a new framework for identifying research studies at risk of being biased and the information in this article will promote a unification of the diverse approaches to facilitating bias assessment in clinical research.

An update on second-generation devices for endometrial ablation.

Menorrhagia is a very common problem. Hysterectomy has been the traditional surgical treatment of choice guaranteeing amenorrhoea. It is 100% effective but is associated with surgical complications, and is more costly in terms of economic impact and recovery time. Minimally invasive procedures to ablate the endometrium reduce complications and recovery time. The newer second-generation endometrial ablation devices negate the need for surgery under direct hysteroscopic vision, thus ensuring that the treatments are not operator dependent. However, they heavily rely on the device themselves to ensure safety and efficacy. There are a variety of these devices currently available on the market. The authors will review these devices and provide the evidence for their suitability in various settings.