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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.

Background In its 2006 report, From cancer patient to cancer survivor: lost in transition , the U.S. Institute of Medicine raised the need for a more coordinated and comprehensive care model for cancer survivors. Given the ever increasing number of cancer survivors, in general, and prostate cancer survivors, in particular, there is a need for a more sustainable model of follow-up care. Currently, patients who have completed primary treatment for localized prostate cancer are often included in a specialist-based follow-up care program. General practitioners already play a key role in providing continuous and comprehensive health care. Studies in breast and colorectal cancer suggest that general practitioners could also consider to provide survivorship care in prostate cancer. However, empirical data are needed to determine whether follow-up care of localized prostate cancer survivors by the general practitioner is a feasible alternative. Methods This multicenter, randomized, non-inferiority study will compare specialist-based (usual care) versus general practitioner-based (intervention) follow-up care of prostate cancer survivors who have completed primary treatment (prostatectomy or radiotherapy) for localized prostate cancer. Patients are being recruited from hospitals in the Netherlands, and randomly (1:1) allocated to specialist-based ( N  = 195) or general practitioner-based ( N  = 195) follow-up care. This trial will evaluate the effectiveness of primary care-based follow-up, in comparison to usual care, in terms of adherence to the prostate cancer surveillance guideline for the timing and frequency of prostate-specific antigen assessments, the time from a biochemical recurrence to retreatment decision-making, the management of treatment-related side effects, health-related quality of life, prostate cancer-related anxiety, continuity of care, and cost-effectiveness. The outcome measures will be assessed at randomization (≤6 months after treatment), and 12, 18, and 24 months after treatment. Discussion This multicenter, prospective, randomized study will provide empirical evidence regarding the (cost-) effectiveness of specialist-based follow-up care compared to general practitioner-based follow-up care for localized prostate cancer survivors. Trial registration Netherlands Trial Registry, Trial NL7068 (NTR7266). Prospectively registered on 11 June 2018

Global action plans to tackle antimicrobial resistance (AMR) include implementation of antimicrobial stewardship (AMS), but few studies have directly addressed the challenges faced by low and middle-income countries (LMICs). Our aim was to explore healthcare providers' knowledge and perceptions on AMR, and barriers/facilitators to successful implementation of a pharmacist-led AMS intervention in a referral hospital in Ethiopia. Tikur Anbessa Specialized Hospital (TASH) is an 800-bed tertiary center in Addis Ababa, and the site of an ongoing 4-year study on AMR. Between May and July 2017, using a mixed approach of quantitative and qualitative methods, we performed a cross-sectional survey of pharmacists and physicians using a pre-tested questionnaire and semi-structured interviews of purposively selected respondents until thematic saturation. We analyzed differences in proportions of agreement between physicians and pharmacists using χ2 and fisher exact tests. Qualitative data was analyzed thematically. A total of 406 survey respondents (358 physicians, 48 pharmacists), and 35 key informants (21 physicians and 14 pharmacists) were enrolled. The majority of survey respondents (>90%) strongly agreed with statements regarding the global scope of AMR, the need for stewardship, surveillance and education, but their perceptions on factors contributing to AMR and their knowledge of institutional resistance profiles for common bacteria were less uniform. Close to 60% stated that a significant proportion of S. aureus infections were caused by methicillin-resistant strains (an incorrect statement), while only 48% thought a large proportion of gram-negative infections were caused by cephalosporin-resistant strains (a true statement). Differences were noted between physicians and pharmacists: more pharmacists agreed with statements on links between use of broad-spectrum antibiotics and AMR (p<0.022), but physicians were more aware that lack of diagnostic tests led to antibiotic overuse (p<0.01). More than cost, fear of treatment failure and of retribution from senior physicians were major drivers of antibiotic prescription behavior particularly among junior physicians. All respondents identified high turnover of pharmacists, poor communication between the laboratory, pharmacists and clinicians as potential challenges; but the existing hierarchical culture and academic setting were touted as opportunities to implement AMS in Ethiopia. This knowledge and perceptions survey identified specific educational priorities and implementation strategies for AMS in our setting. This is likely also true in other LMICs, where expertise and infrastructure may be lacking.

Background: Clinical guidelines are a constructive response to the reality that practicing physicians require assistance in assimilating and applying the exponentially expanding, often contradictory, body of medical knowledge. They attempt to define practices that meet the needs of most patients under most circumstances. Ideally, specific clinical recommendations contained within practice guidelines are systematically developed by expert panels who have access to all the available evidence, have an understanding of the clinical problem, and have clinical experience with the procedure being assessed, as well as knowledge of relevant research methods. The recent development of American Pain Society (APS) guidelines has created substantial controversy because of their perceived lack of objective analysis and recommendations perceived to be biased due to conflicts of interest. Objectives: To formally and carefully assess the APS guidelines’ evidence synthesis for low back pain for therapeutic interventions using the same methodology utilized by the APS authors. The interventions examined were therapeutic interventions for managing low back pain, including epidural injections, adhesiolysis, facet joint interventions, and spinal cord stimulation. Methods: A literature search by 2 authors was carried out utilizing appropriate databases from 1966 through July 2008. Articles in which conflicts arose were reviewed and mediated by a third author to arrive at a consensus. Selections of manuscripts and methodologic quality assessment was also performed by at least 2 authors utilizing the same criteria applied in the APS guidelines. The guideline reassessment process included the evaluation of individual studies and systematic reviews and their translation into practice recommendations. Results: The conclusions of APS and our critical assessment based on grading of good, fair, and poor, agreed that there is fair evidence for spinal cord stimulation in post lumbar surgery syndrome, and poor evidence for lumbar intraarticular facet joint injections, lumbar interlaminar epidural injections, caudal epidural steroids for conditions other than disc herniation or radiculitis, sacroiliac joint injections, intradiscal electrothermal therapy, endoscopic adhesiolysis, and intrathecal therapy. However, our assessment of APS guidelines for other interventional techniques, utilizing their own criteria, showed fair evidence for therapeutic lumbar facet joint nerve blocks, caudal epidural injections in disc herniation or radiculitis, percutaneous adhesiolysis in post lumbar surgery syndrome, radiofrequency neurotomy, and transforaminal epidural injections in radiculitis. Also it is illustrated that inclusion of latest literature will change the conclusions, with improved grading – caudal epidural, adhesiolysis, and lumbar facet joint nerve blocks from fair to good or poor to fair. The present critical assessment review illustrates that APS guidelines have utilized multiple studies inappropriately and have excluded appropriate studies. Our integrity assessment shows deep concerns that the APS guidelines illustrating significant methodologic failures which raise concerns about transparency, accountability, consistency, and independence. Conclusion: The current reassessment, using appropriate methodology, shows evidence similar to APS guidelines for several procedures, but differs extensively from published APS guidelines for multiple other procedures including caudal epidural injections, lumbar facet joint nerve blocks, lumbar radiofrequency neurotomy, and percutaneous adhesiolysis. Key words: Guidelines, evidence-based medicine, systematic reviews, American Pain Society, interventional pain management, interventional techniques

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.

There is an ongoing debate concerning which guidelines and monitoring tools are most beneficial for assessing labour progression, to help prevent use of intrapartum caesarean section (ICS). The WHO partograph has been used for decades with the assumption of a linear labour progression; however, in 2010, Zhang introduced a new guideline suggesting a more dynamic labour progression. We aimed to investigate whether the frequency of ICS use differed when adhering to the WHO partograph versus Zhang's guideline for labour progression. We did a multicentre, cluster-randomised controlled trial at obstetric units in Norway, and each site was required to deliver more than 500 fetuses per year to be eligible for inclusion. The participants were nulliparous women who had a singleton, full-term fetus with cephalic presentation, and who entered spontaneous active labour. The obstetric units were treated as clusters, and women treated within these clusters were all given the same treatment. We stratified these clusters by size and number of previous caesarean sections. The clusters containing the obstetric units were then randomly assigned (1:1) to the control group, which adhered to the WHO partograph, or to the intervention group, which adhered to Zhang's guideline. The randomisation was computer-generated and was done in the Unit of Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway, and investigators in this unit had no further involvement in the trial. Our study design did not enable masking of participants or health-care providers, but the investigators who were analysing the data were masked to group allocation. The primary outcome was use of ICS during active labour (cervical dilatation of 4–10 cm) in all participating women. The Labour Progression Study (LaPS) is registered with ClinicalTrials.gov, number NCT02221427. Between Aug 1, 2014, and Sept 1, 2014, 14 clusters were enrolled in the LaPS trial, and on Sept 11, 2014, seven obstetric units were randomly assigned to the control group (adhering to the WHO partograph) and seven obstetric units were randomly assigned to the intervention group (adhering to Zhang's guideline). Between Dec 1, 2014, and Jan 31, 2017, 11 615 women were judged to be eligible for recruitment in the trial, which comprised 5421 (46·7%) women in the control group units and 6194 (53·3%) women in the intervention group units. In the control group, 2100 (38·7%) of 5421 women did not give signed consent to participate and 16 (0·3%) women abstained from participation. In the intervention group, 2181 (35·2%) of 6194 women did not give signed consent to participate and 41 (0·7%) women abstained from participation. 7277 (62·7%) of 11 615 eligible women were therefore included in the analysis of the primary endpoint. Of these women, 3305 (45·4%) participants were in an obstetric unit that was randomly assigned to the control group (adhering to the WHO partograph) and 3972 (54·6%) participants were in an obstetric unit that was randomly assigned to the intervention group (adhering to Zhang's guideline). No women dropped out during the trial. Before the start of the trial, ICS was used in 9·5% of deliveries in the control group obstetric units and in 9·3% of intervention group obstetric units. During our trial, there were 196 (5·9%) ICS deliveries in women in the control group (WHO partograph) and 271 (6·8%) ICS deliveries in women in the intervention group (Zhang's guideline), and the frequency of ICS use did not differ between the groups (adjusted relative risk 1·17, 95% CI 0·98–1·40; p=0·08; adjusted risk difference 1·00%, 95% CI −0·1 to 2·1). We identified no maternal or neonatal deaths during our study. We did not find any significant difference in the frequency of ICS use between the obstetric units assigned to adhere to the WHO partograph and those assigned to adhere to Zhang's guideline. The overall decrease in ICS use that we observed relative to the previous frequency of ICS use noted in these obstetric units might be explained by the close focus on assessing labour progression more than use of the guidelines. Our results represent an important contribution to the discussion on implementation of the new guideline. Østfold Hospital Trust.

Background Rates of opioid prescribing tripled in the USA between 1999 and 2015 and were associated with significant increases in opioid misuse and overdose death. Roughly half of all opioids are prescribed in primary care. Although clinical guidelines describe recommended opioid prescribing practices, implementing these guidelines in a way that balances safety and effectiveness vs. risk remains a challenge. The literature offers little help about which implementation strategies work best in different clinical settings or how strategies could be tailored to optimize their effectiveness in different contexts. Systems consultation consists of (1) educational/engagement meetings with audit and feedback reports, (2) practice facilitation, and (3) prescriber peer consulting. The study is designed to discover the most cost-effective sequence and combination of strategies for improving opioid prescribing practices in diverse primary care clinics. Methods/design The study is a hybrid type 3 clustered, sequential, multiple-assignment randomized trial (SMART) that randomizes clinics from two health systems at two points, months 3 and 9, of a 21-month intervention. Clinics are provided one of four sequences of implementation strategies: a condition consisting of educational/engagement meetings and audit and feedback alone (EM/AF), EM/AF plus practice facilitation (PF), EM/AF + prescriber peer consulting (PPC), and EM/AF + PF + PPC. The study’s primary outcome is morphine-milligram equivalent (MME) dose by prescribing clinicians within clinics. The study’s primary aim is the comparison of EM/AF + PF + PPC versus EM/AF alone on change in MME from month 3 to month 21. The secondary aim is to derive cost estimates for each of the four sequences and compare them. The exploratory aim is to examine four tailoring variables that can be used to construct an adaptive implementation strategy to meet the needs of different primary care clinics. Discussion Systems consultation is a practical blend of implementation strategies used in this case to improve opioid prescribing practices in primary care. The blend offers a range of strategies in sequences from minimally to substantially intensive. The results of this study promise to help us understand how to cost effectively improve the implementation of evidence-based practices. Trial registration NCT 04044521 (ClinicalTrials.gov). Registered 05 August 2019.

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.

Background Initial management decisions following a new episode of low back pain (LBP) are thought to have profound implications for health care utilization and costs. The purpose of this study was to evaluate the impact of early and guideline adherent physical therapy for low back pain on utilization and costs within the Military Health System (MHS). Methods Patients presenting to a primary care setting with a new complaint of LBP from January 1, 2007 to December 31, 2009 were identified from the MHS Management Analysis and Reporting Tool. Descriptive statistics, utilization, and costs were examined on the basis of timing of referral to physical therapy and adherence to practice guidelines over a 2-year period. Utilization outcomes (advanced imaging, lumbar injections or surgery, and opioid use) were compared using adjusted odds ratios with 99% confidence intervals. Total LBP-related health care costs over the 2-year follow-up were compared using linear regression models. Results 753,450 eligible patients with a primary care visit for LBP between 18–60 years of age were considered. Physical therapy was utilized by 16.3% (n = 122,723) of patients, with 24.0% (n = 17,175) of those receiving early physical therapy that was adherent to recommendations for active treatment. Early referral to guideline adherent physical therapy was associated with significantly lower utilization for all outcomes and 60% lower total LBP-related costs. Conclusions The potential for cost savings in the MHS from early guideline adherent physical therapy may be substantial. These results also extend the findings from similar studies in civilian settings by demonstrating an association between early guideline adherent care and utilization and costs in a single payer health system. Future research is necessary to examine which patients with LBP benefit early physical therapy and determine strategies for providing early guideline adherent care.

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.