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Seminars in Perinatology Aug 2023We present a systematic scoping review of the literature, which documents that only a very small number of interventions related to delivery room stabilization and...
We present a systematic scoping review of the literature, which documents that only a very small number of interventions related to delivery room stabilization and resuscitation have been studied for their economic impact. Published analyses are mostly of programmatic interventions such as resuscitation training programs, are mostly in low-resource settings, and are of variable methodological quality. Investigators who are conducting clinical studies of delivery room interventions can address these deficiencies in the literature by engaging with health services researchers to assess economic outcomes alongside those studies. We provide a framework of five questions that clinical researchers may use to decide on when such an ancillary study is indicated, and to provide them with the necessary language to discuss the methodological details of potential evaluations with their health services colleagues. Emphasis should be given to interventions that are targeted to high volumes of patients, are expensive, or are likely to lead to changes in costly chronic outcomes.
Topics: Humans; Infant, Newborn; Cost-Benefit Analysis; Resuscitation
PubMed: 37380528
DOI: 10.1016/j.semperi.2023.151783 -
Journal of Clinical Medicine May 2023Recent years have seen the emergence and application of artificial intelligence (AI) in diagnostic decision support systems. There are approximately 80 etiologies that... (Review)
Review
Recent years have seen the emergence and application of artificial intelligence (AI) in diagnostic decision support systems. There are approximately 80 etiologies that can underly uveitis, some very rare, and AI may lend itself to their detection. This synthesis of the literature selected articles that focused on the use of AI in determining the diagnosis, classification, and underlying etiology of uveitis. The AI-based systems demonstrated relatively good performance, with a classification accuracy of 93-99% and a sensitivity of at least 80% for identifying the two most probable etiologies underlying uveitis. However, there were limitations to the evidence. Firstly, most data were collected retrospectively with missing data. Secondly, ophthalmic, demographic, clinical, and ancillary tests were not reliably integrated into the algorithms' dataset. Thirdly, patient numbers were small, which is problematic when aiming to discriminate rare and complex diagnoses. In conclusion, the data indicate that AI has potential as a diagnostic decision support system, but clinical applicability is not yet established. Future studies and technologies need to incorporate more comprehensive clinical data and larger patient populations. In time, these should improve AI-based diagnostic tools and help clinicians diagnose, classify, and manage patients with uveitis.
PubMed: 37297939
DOI: 10.3390/jcm12113746 -
Barriers and facilitators to the implementation of guidelines in rare diseases: a systematic review.Orphanet Journal of Rare Diseases Jun 2023Rare diseases present a challenge to guideline implementation due to a low prevalence in the general population and the unfamiliarity of healthcare professionals....
BACKGROUND
Rare diseases present a challenge to guideline implementation due to a low prevalence in the general population and the unfamiliarity of healthcare professionals. Existing literature in more common diseases references barriers and facilitators to guideline implementation. This systematic review aims to identify these barriers and facilitators in rare diseases from existing literature.
METHODS
A multi-stage strategy included searching MEDLINE PubMed, EMBASE Ovid, Web of Science and Cochrane library from the earliest date available to April 2021, Orphanet journal hand-search, a pearl-growing strategy from a primary source and reference/citation search was performed. The Integrated Checklist of Determinants of Practice which comprises of twelve checklists and taxonomies, informed by 57 potential determinants was selected as a screening tool to identify determinants that warrant further in-depth investigation to inform design of future implementation strategies.
RESULTS
Forty-four studies were included, most of which were conducted in the United States (54.5%). There were 168 barriers across 36 determinants (37 studies) and 52 facilitators across 22 determinants (22 studies). Fifteen diseases were included across eight WHO ICD-11 disease categories. Together individual health professional factors and guideline factors formed the majority of the reported determinants (59.5% of barriers and 53.8% of facilitators). Overall, the three most reported individual barriers were the awareness/familiarity with the recommendation, domain knowledge and feasibility. The three most reported individual facilitators were awareness/familiarity with the recommendation, agreement with the recommendation and ability to readily access the guidelines. Resource barriers to implementation included technology costs, ancillary staff costs and more cost-effective alternatives. There was a paucity of studies reporting influential people, patient advocacy groups or opinion leaders, or organisational factors influencing implementation.
CONCLUSIONS
Key barriers and facilitators to the implementation of clinical practice guidelines in the setting of rare diseases were at the individual health professional and guideline level. Influential people and organisational factors were relatively under-reported and warrant exploration, as does increasing the ability to access the guidelines as a potential intervention.
Topics: Humans; Rare Diseases; Health Personnel
PubMed: 37286999
DOI: 10.1186/s13023-023-02667-9 -
Canadian Journal of Anaesthesia =... Apr 2023Ancillary tests are frequently used in death determination by neurologic criteria (DNC), particularly when the clinical neurologic examination is unreliable.... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Ancillary tests are frequently used in death determination by neurologic criteria (DNC), particularly when the clinical neurologic examination is unreliable. Nevertheless, their diagnostic accuracy has not been extensively studied. Our objective was to synthesize the sensitivity and specificity of commonly used ancillary tests for DNC.
SOURCE
We performed a systematic review and meta-analysis by searching MEDLINE, EMBASE, Cochrane databases, and CINAHL Ebsco from their inception to 4 February 2022. We selected cohort and case-control studies including patients with 1) clinically diagnosed death by neurologic criteria or 2) clinically suspected death by neurologic criteria who underwent ancillary testing for DNC. We excluded studies without a priori diagnostic criteria and studies conducted solely on pediatric patients. Accepted reference standards were clinical examination, four-vessel conventional angiography, and radionuclide imaging. Data were directly extracted from published reports. We assessed the methodological quality of studies with the QUADAS-2 tool and estimated ancillary test sensitivities and specificities using hierarchical Bayesian models with diffuse priors.
PRINCIPAL FINDINGS
Overall, 137 records met the selection criteria. One study (0.7%) had a low risk of bias in all QUADAS-2 domains. Among clinically diagnosed death by neurologic criteria patients (n = 8,891), ancillary tests had similar pooled sensitivities (range, 0.82-0.93). Sensitivity heterogeneity was greater within (σ = 0.10-0.15) than between (σ = 0.04) ancillary test types. Among clinically suspected death by neurologic criteria patients (n = 2,732), pooled ancillary test sensitivities ranged between 0.81 and 1.00 and specificities between 0.87 and 1.00. Most estimates had high statistical uncertainty.
CONCLUSION
Studies assessing ancillary test diagnostic accuracy have an unclear or high risk of bias. High-quality studies are required to thoroughly validate ancillary tests for DNC.
STUDY REGISTRATION
PROSPERO (CRD42013005907); registered 7 October 2013.
Topics: Humans; Child; Bayes Theorem; Sensitivity and Specificity; Case-Control Studies
PubMed: 37155120
DOI: 10.1007/s12630-023-02426-1 -
Canadian Journal of Anaesthesia =... Apr 2023We performed a systematic review and meta-analysis to determine the diagnostic test accuracy of ancillary investigations for declaration of death by neurologic criteria... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
We performed a systematic review and meta-analysis to determine the diagnostic test accuracy of ancillary investigations for declaration of death by neurologic criteria (DNC) in infants and children.
SOURCE
We searched MEDLINE, EMBASE, Web of Science, and Cochrane databases from their inception to June 2021 for relevant randomized controlled trials, observational studies, and abstracts published in the last three years. We identified relevant studies using Preferred Reporting Items for Systematic Reviews and Meta-Analysis methodology and a two-stage review. We assessed the risk of bias using the QUADAS-2 tool, and applied Grading of Recommendations Assessment, Development, and Evaluation methodology to determine the certainty of evidence. A fixed-effects model was used to meta-analyze pooled sensitivity and specificity data for each ancillary investigation with at least two studies.
PRINCIPAL FINDINGS
Thirty-nine eligible manuscripts assessing 18 unique ancillary investigations (n = 866) were identified. The sensitivity and specificity ranged from 0.00 to 1.00 and 0.50 to 1.00, respectively. The quality of evidence was low to very low for all ancillary investigations, with the exception of radionuclide dynamic flow studies for which it was graded as moderate. Radionuclide scintigraphy using the lipophilic radiopharmaceutical Tc-hexamethylpropyleneamine oxime (HMPAO) with or without tomographic imaging were the most accurate ancillary investigations with a combined sensitivity of 0.99 (95% highest density interval [HDI], 0.89 to 1.00) and specificity of 0.97 (95% HDI, 0.65 to 1.00).
CONCLUSION
The ancillary investigation for DNC in infants and children with the greatest accuracy appears to be radionuclide scintigraphy using HMPAO with or without tomographic imaging; however, the certainty of the evidence is low. Nonimaging modalities performed at the bedside require further investigation.
STUDY REGISTRATION
PROSPERO (CRD42021278788); registered 16 October 2021.
Topics: Humans; Child; Infant; Bias; Sensitivity and Specificity
PubMed: 37131035
DOI: 10.1007/s12630-023-02418-1 -
International Journal of Chronic... 2023Inhaled corticosteroids (ICSs) combined with bronchodilators have been identified to improve outcomes in COPD but also to be associated with certain adverse effects. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Inhaled corticosteroids (ICSs) combined with bronchodilators have been identified to improve outcomes in COPD but also to be associated with certain adverse effects.
OBJECTIVE
We performed a systematic review and meta-analysis to compile and summarize data on the efficacy and safety of dosing levels (high versus medium/low) of ICS alongside ancillary bronchodilators following PRISMA guidelines.
DATA SOURCES
Medline and Embase were systematically searched until December 2021. Randomized, clinical trials (RCTs) that met predefined inclusion criteria were included.
DATA EXTRACTION
Risk ratios (RRs) with 95% confidence intervals (CI) were extracted. Any acute exacerbation of COPD (AECOPD) risk was chosen as the primary efficacy outcome, mortality rate as the primary safety outcome, moderate/severe AECOPD risk as the secondary efficacy outcome and pneumonia risk as the secondary safety outcome. Subgroup analyses of individual ICS agents, of patients with baseline moderate/severe/very severe COPD and of patients with recent COPD exacerbation history were also performed. A random-effects model was used.
RESULTS
We included 13 RCTs in our study. No data on low doses were included in the analysis. High dose ICS was not associated with a statistically significant difference in any AECOPD risk (RR: 0.98, 95% CI: 0.91-1.05, I: 41.3%), mortality rate (RR: 0.99, 95% CI: 0.75-1.32, I: 0.0%), moderate/severe AECOPD risk (RR: 1.01, 95% CI: 0.96-1.06, I: 0.0%) or pneumonia risk (RR: 1.07, 95% CI: 0.86 -1.33, I: 9.3%) compared to medium dose ICS. The same trend was identified with the several subgroup analyses.
CONCLUSION
Our study collected RCTs investigating the optimal dosing level of ICS prescribed alongside ancillary bronchodilators to patients with COPD. We identified that the high ICS dose neither reduces AECOPD risk and mortality rates nor increases pneumonia risk relative to the medium dose.
Topics: Humans; Bronchodilator Agents; Pulmonary Disease, Chronic Obstructive; Adrenal Cortex Hormones; Pneumonia; Administration, Inhalation
PubMed: 37056683
DOI: 10.2147/COPD.S401736 -
Histopathology Jul 2023PRAME is a novel immunohistochemical marker that aids the diagnosis of melanocytic lesions. Diffuse PRAME positivity suggests melanoma, whereas benign naevi are negative... (Meta-Analysis)
Meta-Analysis Review
PRAME is a novel immunohistochemical marker that aids the diagnosis of melanocytic lesions. Diffuse PRAME positivity suggests melanoma, whereas benign naevi are negative or only weakly positive. However, the factual diagnostic accuracy of PRAME is not well established. Moreover, some studies have suggested that the threshold of 3+/50% positive cells may be more useful in practice than the most widely used cut-off (4+/75% of positive cells). Hence, we performed a systematic review and diagnostic accuracy meta-analysis to evaluate sensitivity, specificity, likelihood ratios and optimal threshold for PRAME in distinguishing benign melanocytic proliferations from melanomas. Twenty-six studies were enrolled into the meta-analysis. A total of 2915 melanocytic lesions were analysed. The optimal threshold for PRAME positivity was estimated at 3.11, which translates into 3+ in practice. Sensitivity and specificity calculated from SROC at the 3+ threshold were 0.735 (0.631-0.818) and 0.915 (0.834-0.958), respectively, compared to 0.679 (0.559-0.957) and 0.957 (0.908-0.981) at the 4+ cut-off. In subgroup analysis, the spitzoid subgroup was characterised by the lowest sensitivity and diagnostic odds ratio of PRAME. Our findings indicate that PRAME immunohistochemistry may serve as an ancillary marker to support the diagnosis of melanoma. Nevertheless, the accuracy of PRAME may be lower in spitzoid neoplasms. Our meta-analysis suggests that the 3+/50% threshold might be more useful in practice than the 4+/75% cut-off, as it shows higher sensitivity with retained satisfactory specificity.
Topics: Humans; Melanoma; Skin Neoplasms; Melanocytes; Diagnostic Tests, Routine; Antigens, Neoplasm; Melanoma, Cutaneous Malignant
PubMed: 36942814
DOI: 10.1111/his.14904 -
Frontiers in Public Health 2023Optimal breastfeeding (BF) practices are essential for child survival and proper growth and development. The purpose of this overview is to evaluate the effectiveness of...
BACKGROUND
Optimal breastfeeding (BF) practices are essential for child survival and proper growth and development. The purpose of this overview is to evaluate the effectiveness of different interventions for promoting and optimizing breastfeeding.
METHODS
We included systematic reviews (SRs) [including trials from Low-Income (LICs) and Low Middle-Income countries (LMICs)] that have evaluated the effect of various interventions for promoting and optimizing breastfeeding and excluded non-systematic reviews, and SRs based on observational studies. We searched various electronic databases. We followed the standard methodology as suggested by the Cochrane Handbook for Systematic Reviews of Interventions. Two sets of reviewers undertook screening followed by data extraction and assessment of the methodological quality of included SRs.
RESULT
We identified and screened 1,002 Cochrane SRs and included six SRs in this overview. Included SRs reported only two of the primary outcomes, early initiation of breastfeeding (EIBF) and/or exclusive breastfeeding (EBF). None of the included SR reported continued BF up to 2 years of age. The results were evaluated using two major comparisons groups: BF intervention against routine care and one type of BF intervention vs. other types of BF intervention. Overall results from included SRs showed that there were improvements in the rates of EIBF and EBF among women who received BF intervention such as BF education sessions and support compared to those women who received only standard care. However, BF intervention mobile devices showed no improvements. In Target Client Communication (TCC) mobile devices intervention group, no significant improvements were reported in BF practices, and also the reported evidence was of very low certainty.
CONCLUSION
Community Based Intervention Packages (CBIP) delivered to pregnant and reproductive-age women during their Antenatal care (ANC) and/or Postnatal care (PNC) periods by Ancillary Nurse-Midwives reported the highest improvement in EIBF compared to women who received standard care. However, insufficient evidence was reported to suggest that BF intervention showed improvements in EBF in both the comparison groups. This overview highlighted the gaps in primary research regarding the uncertainty about the settings such as LICs or LMICs, lack of evidence from LMICs, and also identified gaps in the availability of reliable up-to-date SRs on the effects of several BF interventions to promote and optimize practices.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020174998, PROSPERO [CRD42020174998].
Topics: Child; Female; Pregnancy; Humans; Breast Feeding; Systematic Reviews as Topic; Prenatal Care; Communication; Uncertainty
PubMed: 36761137
DOI: 10.3389/fpubh.2023.984876 -
International Journal of Molecular... Dec 2022Extrathyroidal extension (ETE) in patients with papillary thyroid carcinoma (PTC) is an indication of disease progression and can influence treatment aggressiveness.... (Meta-Analysis)
Meta-Analysis Review
Extrathyroidal extension (ETE) in patients with papillary thyroid carcinoma (PTC) is an indication of disease progression and can influence treatment aggressiveness. This meta-analysis assesses the diagnostic accuracy of ultrasonography (US) in detecting ETE. A systematic review and meta-analysis were performed by searching PubMed, Embase, and Cochrane for studies published up to April 2022. The pooled sensitivity, specificity, and diagnostic odds ratio (DOR) were calculated. The areas under the curve (AUC) for summary receiver operating curves were compared. A total of 11 studies analyzed ETE in 3795 patients with PTC. The sensitivity of ETE detection was 76% (95%CI = 74-78%). The specificity of ETE detection was 51% (95%CI = 49-54%). The DOR of detecting ETE by US was 5.32 (95%CI = 2.54-11.14). The AUC of ETE detection was determined to be 0.6874 ± 0.0841. We report an up-to-date analysis elucidating the diagnostic accuracy of ETE detection by US. Our work suggests the diagnostic accuracy of US in detecting ETE is adequate. Considering the importance of ETE detection on preoperative assessment, ancillary studies such as adjunct imaging studies and genetic testing should be considered.
Topics: Humans; Thyroid Cancer, Papillary; Thyroid Neoplasms; Carcinoma, Papillary; Ultrasonography; Odds Ratio; Retrospective Studies
PubMed: 36613811
DOI: 10.3390/ijms24010371 -
European Urology Open Science Jan 2023The advent of immune check inhibitors (ICIs) has tremendously changed the prognosis of metastatic renal cell carcinoma (mRCC), adding an unseen substantial overall... (Review)
Review
CONTEXT
The advent of immune check inhibitors (ICIs) has tremendously changed the prognosis of metastatic renal cell carcinoma (mRCC), adding an unseen substantial overall survival benefit. These agents could be administered alone or in combination with anti-vascular endothelial growth factor (anti-VEGF) therapies. So far, treatment allocation is based only on clinical stratification risk models.
OBJECTIVE
Herein, we aimed to report the different molecular classifications reported in the first-line treatment of mRCC and discuss the awaited clinical implications in terms of treatment selection.
EVIDENCE ACQUISITION
Medline database as well as European Society for Medical Oncology (ESMO)/American Society of Clinical Oncology (ASCO) conference proceedings were searched to identify biomarker studies. Inclusion criteria comprised randomized and nonrandomized clinical trials that included patients treated in the first line of mRCC setting, patients treated with anti-VEGF therapies or ICIs, biological modeling, and available survival outcomes.
EVIDENCE SYNTHESIS
Four classification models were identified with subsequent clinical implications: Beuselinck model (34 gene signatures), IMmotion150, Hakimi, and JAVELIN 101 model. Tumor profiling shows distinct outcomes when treated with one or other combination. Patients are clustered into two gene signatures: angiogenic and proinflammatory (as per JAVELIN). The first is more likely to respond to therapy that includes anti-VEGF agents, while the best outcomes are obtained with an ICI combination with the second.
CONCLUSIONS
The findings presented here were mostly derived from ancillary registered studies of new drugs in the setting of mRCC. Further validation is needed, which sets new paradigms for investigation in clinical research based on tumor biology for treatment allocation and not only on clinical stratification tools.
PATIENT SUMMARY
First-line treatment of metastatic kidney includes immunotherapy alone or in combination with antiangiogenic therapy. However, clinical practice demonstrated that the "one treatment fits all" strategy might not be the best approach. In fact, recent studies showed that the addition of immunotherapy agents will not benefit all patients equally, and some still respond either equally to or better than anti-vascular endothelial growth factor alone. This review revealed biomarker modeling that impacts treatment selection. Recent tumor profiling into "angiogenic signature" more sensitive to angiogenic agents versus "immune signature" more likely to achieve the best response with immunotherapy should be validated. Tumor biology features might be more powerful than clinical classification for a tailored treatment approach.
PubMed: 36573246
DOI: 10.1016/j.euros.2022.11.006