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Background The World Health Organization (WHO) International Classification of Diseases and Related Health Problems (ICD) is used globally by 194 WHO member nations. It is used for assigning clinical diagnoses, providing the framework for reporting public health data, and to inform the organization and reimbursement of health services. Guided by overarching principles of increasing clinical utility and global applicability, the 11th revision of the ICD proposes major changes that incorporate empirical advances since the previous revision in 1992. To test recommended changes in the Mental, Behavioral, and Neurodevelopmental Disorders chapter, multiple vignette-based case-controlled field studies have been conducted which examine clinicians’ ability to accurately and consistently use the new guidelines and assess their overall clinical utility. This manuscript reports on the results from the study of the proposed ICD-11 guidelines for feeding and eating disorders (FEDs). Method Participants were 2288 mental health professionals registered with WHO’s Global Clinical Practice Network. The study was conducted in Chinese, English, French, Japanese, and Spanish. Clinicians were randomly assigned to apply either the ICD-11 or ICD-10 diagnostic guidelines for FEDs to a pair of case vignettes designed to test specific clinical questions. Clinicians selected the diagnosis they thought was correct for each vignette, evaluated the presence of each essential feature of the selected diagnosis, and the clinical utility of the diagnostic guidelines. Results The proposed ICD-11 diagnostic guidelines significantly improved accuracy for all FEDs tested relative to ICD-10 and attained higher clinical utility ratings; similar results were obtained across all five languages. The inclusion of binge eating disorder and avoidant-restrictive food intake disorder reduced the use of residual diagnoses. Areas needing further refinement were identified. Conclusions The proposed ICD-11 diagnostic guidelines consistently outperformed ICD-10 in distinguishing cases of eating disorders and showed global applicability and appropriate clinical utility. These results suggest that the proposed ICD-11 guidelines for FEDs will help increase accuracy of public health data, improve clinical diagnosis, and enhance health service organization and provision. This is the first time in the revision of the ICD that data from large-scale, empirical research examining proposed guidelines is completed in time to inform the final diagnostic guidelines.

AbstractObjectivesTo evaluate the compliance with prospective registration and inclusion of the trial registration number (TRN) in published randomised controlled trials (RCTs), and to analyse the rationale behind, and detect selective registration bias in, retrospective trial registration.DesignCross sectional analysis.Data sourcesPubMed, the 17 World Health Organization’s trial registries, University of Toronto library, International Committee of Medical Journal Editors (ICMJE) list of member journals, and the InCites Journal Citation Reports.Study selection criteriaRCTs registered in any WHO trial registry and published in any PubMed indexed journal in 2018.ResultsThis study included 10 500 manuscripts published in 2105 journals. Overall, 71.2% (7473/10500) reported the TRN and 41.7% (3013/7218) complied with prospective trial registration. The univariable and multivariable analyses reported significant relations (P<0.05) between reporting the TRN and the impact factor and ICMJE membership of the publishing journal. A significant relation (P<0.05) was also observed between prospective trial registration and the registry, region, condition, funding, trial size, interval between paper registration and submission dates, impact factor, and ICMJE membership of the publishing journal. A manuscript published in an ICMJE member journal was 5.8 times more likely to include the TRN (odds ratio 5.8, 95% confidence interval 4.0 to 8.2), and a published trial was 1.8 times more likely to be registered prospectively (1.8, 1.5 to 2.2) when published in an ICMJE member journal compared with other journals. This study detected a new form of bias, selective registration bias, with a higher proportion (85.2% (616/723)) of trials registered retrospectively within a year of submission for publication. Higher rates of retrospective registrations were observed within the first three to eight weeks after enrolment of study participants. Within the 286 RCTs registered retrospectively and published in an ICMJE member journal, only 2.8% (8/286) of the authors included a statement justifying the delayed registration. Reasons included lack of awareness, error of omission, and the registration process taking longer than anticipated.ConclusionsThis study found a high compliance in reporting of the TRN for trial papers published in ICMJE member journals, but prospective trial registration was low.

Acute low back pain (LBP) is highly prevalent, with a presumed favorable prognosis; however, once chronic, LBP becomes a disabling and expensive condition. Acute to chronic LBP transition rates vary widely owing to absence of standardized operational definitions, and it is unknown whether a standardized prognostic tool (ie, Subgroups for Targeted Treatment Back tool [SBT]) can estimate this transition or whether early non-guideline concordant treatment is associated with the transition to chronic LBP. To assess the associations between the transition from acute to chronic LBP with SBT risk strata; demographic, clinical, and practice characteristics; and guideline nonconcordant processes of care. This inception cohort study was conducted alongside a multisite, pragmatic cluster randomized trial. Adult patients with acute LBP stratified by SBT risk were enrolled in 77 primary care practices in 4 regions across the United States between May 2016 and June 2018 and followed up for 6 months, with final follow-up completed by March 2019. Data analysis was conducted from January to March 2020. SBT risk strata and early LBP guideline nonconcordant processes of care (eg, receipt of opioids, imaging, and subspecialty referral). Transition from acute to chronic LBP at 6 months using the National Institutes of Health Task Force on Research Standards consensus definition of chronic LBP. Patient demographic characteristics, clinical factors, and LBP process of care were obtained via electronic medical records. Overall, 5233 patients with acute LBP (3029 [58%] women; 4353 [83%] White individuals; mean [SD] age 50.6 [16.9] years; 1788 [34%] low risk; 2152 [41%] medium risk; and 1293 [25%] high risk) were included. Overall transition rate to chronic LBP at six months was 32% (1666 patients). In a multivariable model, SBT risk stratum was positively associated with transition to chronic LBP (eg, high-risk vs low-risk groups: adjusted odds ratio [aOR], 2.45; 95% CI, 2.00-2.98; P < .001). Patient and clinical characteristics associated with transition to chronic LBP included obesity (aOR, 1.52; 95% CI, 1.28-1.80; P < .001); smoking (aOR, 1.56; 95% CI, 1.29-1.89; P < .001); severe and very severe baseline disability (aOR, 1.82; 95% CI, 1.48-2.24; P < .001 and aOR, 2.08; 95% CI, 1.60-2.68; P < .001, respectively) and diagnosed depression/anxiety (aOR, 1.66; 95% CI, 1.28-2.15; P < .001). After controlling for all other variables, patients exposed to 1, 2, or 3 nonconcordant processes of care within the first 21 days were 1.39 (95% CI, 1.21-2.32), 1.88 (95% CI, 1.53-2.32), and 2.16 (95% CI, 1.10-4.25) times more likely to develop chronic LBP compared with those with no exposure (P < .001). In this cohort study, the transition rate to chronic LBP was substantial and increased correspondingly with SBT stratum and early exposure to guideline nonconcordant care.

Information about the variation in the risk for venous thromboembolism (VTE) and in prophylaxis practices around the world is scarce. The ENDORSE (Epidemiologic International Day for the Evaluation of Patients at Risk for Venous Thromboembolism in the Acute Hospital Care Setting) study is a multinational cross-sectional survey designed to assess the prevalence of VTE risk in the acute hospital care setting, and to determine the proportion of at-risk patients who receive effective prophylaxis. All hospital inpatients aged 40 years or over admitted to a medical ward, or those aged 18 years or over admitted to a surgical ward, in 358 hospitals across 32 countries were assessed for risk of VTE on the basis of hospital chart review. The 2004 American College of Chest Physicians (ACCP) evidence-based consensus guidelines were used to assess VTE risk and to determine whether patients were receiving recommended prophylaxis. 68 183 patients were enrolled; 30 827 (45%) were categorised as surgical, and 37 356 (55%) as medical. On the basis of ACCP criteria, 35 329 (51·8%; 95% CI 51·4–52·2; between-country range 35·6–72·6) patients were judged to be at risk for VTE, including 19 842 (64·4%; 63·8–64·9; 44·1–80·2) surgical patients and 15 487 (41·5%; 41·0–42·0; 21·1–71·2) medical patients. Of the surgical patients at risk, 11 613 (58·5%; 57·8–59·2; 0·2–92·1) received ACCP-recommended VTE prophylaxis, compared with 6119 (39·5%; 38·7–40·3; 3·1–70·4) at-risk medical patients. A large proportion of hospitalised patients are at risk for VTE, but there is a low rate of appropriate prophylaxis. Our data reinforce the rationale for the use of hospital-wide strategies to assess patients' VTE risk and to implement measures that ensure that at-risk patients receive appropriate prophylaxis.

Hand hygiene compliance of health-care workers remains suboptimal despite standard multimodal promotion, and evidence for the effectiveness of novel interventions is urgently needed. We aimed to assess the effect of enhanced performance feedback and patient participation on hand hygiene compliance in the setting of multimodal promotion. We did a single-centre, cluster randomised controlled trial at University of Geneva Hospitals (Geneva, Switzerland). All wards hosting adult, lucid patients, and all health-care workers and patients in these wards, were eligible. After a 15-month baseline period, eligible wards were assigned by computer-generated block randomisation (1:1:1), stratified by the type of ward, to one of three groups: control, enhanced performance feedback, or enhanced performance feedback plus patient participation. Standard multimodal hand hygiene promotion was done hospital-wide throughout the study. The primary outcome was hand hygiene compliance of health-care workers (according to the WHO Five Moments of Hand Hygiene) at the opportunity level, measured by direct observation (20-min sessions) by 12 validated infection control nurses, with each ward audited at least once every 3 months. This trial is registered with ISRCTN, number ISRCTN43599478. We randomly assigned 67 wards to the control group (n=21), enhanced performance feedback (n=24), or enhanced performance feedback plus patient participation (n=22) on May 19, 2010. One ward in the control group became a high-dependency unit and was excluded from analysis. During 1367 observation sessions, 12 579 hand hygiene opportunities were recorded. Between the baseline period (April 1, 2009, to June 30, 2010) and the intervention period (July 1, 2010, to June 30, 2012), mean hand hygiene compliance increased from 66% (95% CI 62–70) to 73% (70–77) in the control group (odds ratio [OR] 1·41, 95% CI 1·21–1·63), from 65% (62–69) to 75% (72–77) in the enhanced performance feedback group (1·61, 1·41–1·84), and from 66% (62–70) to 77% (74–80) in the enhanced performance feedback plus patient participation group (1·73, 1·51–1·98). The absolute difference in compliance attributable to interventions was 3 percentage points (95% CI 0–7; p=0·19) for the enhanced performance feedback group and 4 percentage points (1–8; p=0·048) for the enhanced performance feedback plus patient participation group. Hand hygiene compliance remained significantly higher than baseline in all three groups (OR 1·21 [1·00–1·47] vs 1·38 [1·19–1·60] vs 1·36 [1·18–1·57]) during the post-intervention follow-up (Jan 1, 2013, to Dec 31, 2014). Hand hygiene compliance improved in all study groups, and neither intervention had a clinically significant effect compared with control. Improvement in control wards might reflect cross-contamination, highlighting challenges with randomised trials of behaviour change. Swiss National Science Foundation.

Background For effective public health and surveillance it is important to document the proportion of young children who meet the new Australian Integrated 24 h Movement Guidelines for the Early Years and how these associate with health outcomes. We aimed to (i) assess compliance with the new Integrated 24 h Movement Guidelines for the Early Years in a sample of Australian toddlers; and (ii) ascertain whether compliance with the guidelines associates with weight status. Methods The sample comprised 202 toddlers (104 girls) aged 19.74 ± 4.07 months from the GET UP! Study. Participants wore accelerometers (Actigraph GT3X+) for 24 h over 7 consecutive days to assess physical activity, sedentary time and sleep. Parents reported participants’ screen time. Weight and height were measured and body mass index (BMI) z-scores by age and sex were calculated. Analysis of Covariance (ANCOVA) was performed to test differences in BMI z-scores between participants complying with (i) none or any individual guideline, (ii) any combination of meeting two guidelines, and (iii) those who met all three guidelines, adjusting for child age, gender and socioeconomic status. Results Only 8.9% of the sample met the overall 24 h movement guidelines. Most of the sample met the physical activity (96.5%) and sleep (79.7%) guidelines but only 11.4% met the sedentary behavior guideline. Average BMI Z-scores did not significantly differ between children who complied with none or any individual guideline, any combination of meeting two guidelines, and those who met all three guidelines ( p  > 0.05). Although the lack of significant differences, participants who accomplished any combination of two guidelines or all three guidelines appear to have had a lower BMI Z-score than those complying with one of the guidelines or none. Conclusions Just under 9% of our sample met the overall Australian 24 h Movement Guidelines for the Early Years. BMI was not associated with the accomplishment of any of the 24-h Movement Guidelines. Strategies to promote adherence to the 24-h movement guidelines in toddlers, particularly for screen time, are necessary, as promoting health-related behaviors in early childhood has the potential to provide children a strong foundation for lifelong physical and mental health.

BACKGROUND:Endoscopists have low adherence to guideline-recommended colonoscopy surveillance intervals. We performed a cluster-randomized single-blind pilot trial in Winnipeg, Canada, to assess the effectiveness of a newly developed digital application tool that computes guideline-recommended follow-up intervals.METHODS:Participant endoscopists were randomized to either receive access to the digital application (intervention group) or not receive access (control group). Pathology reports and final recommendations for colonoscopies performed in the 1-4 months before randomization and 3-7 months postrandomization were extracted. Generalized estimating equation models were used to determine whether the access to the digital application predicted guideline congruence.RESULTS:We included 15 endoscopists in the intervention group and 14 in the control group (of 42 eligible endoscopists in the city), with 343 patients undergoing colonoscopy before randomization and 311 postrandomization. Endoscopists who received the application made guideline-congruent recommendations 67.6% of the time before randomization and 76.1% of the time after randomization. Endoscopists in the control group made guideline-congruent recommendations 72.4% and 72.9% of the time before and after randomization, respectively. Endoscopists in the intervention group trended to have an increase in guideline adherence comparing postintervention with preintervention (odds ratio [OR]: 1.50, 95% confidence interval [CI] 0.82-2.74). By contrast, the control group had no change in guideline adherence (OR: 1.07, 95% CI 0.50-2.29). Endoscopists in the intervention group with less than median guideline congruence prerandomization had a significant increase in guideline-congruent recommendations postrandomization.DISCUSSION:An application that provides colonoscopy surveillance intervals may help endoscopists with guideline congruence, especially those with a lower preintervention congruence with guideline recommendations (ClincialTrials.gov number, NCT04889352).

Determine the impact of an automated hand hygiene monitoring system (AHHMS) plus complementary strategies on hand hygiene performance rates and healthcare-associated infections (HAIs). Retrospective, nonrandomized, observational, quasi-experimental study. Single, 93-bed nonprofit hospital. Hand hygiene compliance rates were estimated using direct observations. An AHHMS, installed on 4 nursing units in a sequential manner, determined hand hygiene performance rates, expressed as the number of hand hygiene events performed upon entering and exiting patient rooms divided by the number of room entries and exits. Additional strategies implemented to improve hand hygiene included goal setting, hospital leadership support, feeding AHHMS data back to healthcare personnel, and use of Toyota Kata performance improvement methods. HAIs were defined using National Healthcare Safety Network criteria. Hand hygiene compliance rates generated by direct observation were substantially higher than performance rates generated by the AHHMS. Installation of the AHHMS without supplementary activities did not yield sustained improvement in hand hygiene performance rates. Implementing several supplementary strategies resulted in a statistically significant 85% increase in hand hygiene performance rates (P < .0001). The incidence density of non-Clostridioies difficile HAIs decreased by 56% (P = .0841), while C. difficile infections increased by 60% (P = .0533) driven by 2 of the 4 study units. Implementation of an AHHMS, when combined with several supplementary strategies as part of a multimodal program, resulted in significantly improved hand hygiene performance rates. Reductions in non-C. difficile HAIs occurred but were not statistically significant.

To evaluate the impact of Artificial Intelligence Assisted Prevention and Management for Delirium (AI-AntiDelirium) on improving adherence to delirium guidelines among nurses in the intensive care unit (ICU). Between November 2022 and June 2023, A cluster randomized controlled trial was undertaken. A total of 38 nurses were enrolled in the interventional arm, whereas 42 nurses were recruited for the control arm in six ICUs across two hospitals in Beijing, comparing nurses’ adherence and cognitive load in units that use AI-AntiDelirium or the control group. The AI-AntiDelirium tailored delirium preventive or treated interventions to address patients’ specific risk factors. The adherence rate of delirium interventions was the primary endpoint. The other endpoints were adherence to risk factors assessment, ICU delirium assessment, and nurses’ cognitive load. The repeated measures analysis of variance was utilized to explore the influence of time, group, and time × group interaction on the repeated measurement variable (e.g., adherence, cognitive load). A cumulative total of 1040 nurse days were analyzed for this study. The adherence to delirium intervention of nurses in AI-AntiDelirium groups was higher than control units (75 % vs. 58 %, P < 0.01). When compared to control groups, AI-AntiDelirium was found to be significantly effective in both decreasing extraneous cognitive load (P < 0.01) and improving germane cognitive load (P < 0.01). This study supports the effectiveness of AI-AntiDelirium in enhancing nurses’ adherence to evidence-based, individualized delirium intervention and also reducing extraneous cognitive load. A nurse-led systemshould be applied by nursing administrators to improve compliance with nursing interventions among ICU nurses.

Our aim was to determine the coverage of randomized controlled trials (RCTs) by the Consolidated Standards of Reporting Trial (CONSORT) Statement and its extensions and to evaluate the potential workload for authors to adhere to the guidelines. We identified CONSORT extensions from the CONSORT Web site. We randomly selected a sample of 1,000 RCTs indexed in PubMed in 2016 and recorded whether they were covered by CONSORT extensions for specific study designs or interventions. We evaluated the potential workload for authors by counting the number of documents and pages they have to consult to have a full understanding of the guidelines. We identified 14 extensions. Only one extension was updated concurrently with the main CONSORT in 2010, three were updated after 2–7 years, and three are still based on CONSORT 2001. Overall, 81% of RCTs are covered by relevant CONSORT guidelines; missing extensions for specific study designs were under development at the time of the search (Nov 2018). However, 6 of 10 extensions covered <2% of the trials. A median [Q1–Q3] of 4 [4–5] documents and 67 [57–78] pages should be consulted. Most RCTs indexed in PubMed are covered by the CONSORT Statement and extensions, but the potential workload for authors could be high.