Methodological Quality of Pulmonary Arterial Hypertension Treatment Evidence-Based Guidelines: A Systematic Review Using the AGREE II and AGREE REX Tools.

PURPOSE: Pulmonary arterial hypertension (PAH) is a progressive disease with a poor prognosis, and its management should be grounded in well-developed clinical practice guidelines (CPG). Thus, we critically assess the methodological quality of the available CPG for pharmacological treatments for PAH. METHODS: A systematic review (CRD42023387168) was performed in PubMed, Cochrane, Embase, and Tripdatabase (Jan-2023). Eligible records were appraised by four reviewers using the Appraisal of Guidelines, Research, and Evaluation Collaboration tool (AGREE II) and the complementary tool for assessing recommendations' quality and certainty, AGREE REX. Descriptive statistics were used to summarize the data. RESULTS: Overall, 31 guidelines, mainly authored by professional societies (90%), targeting only physicians as primary users (84%), were identified. Guidelines presented a moderate overall quality (scores of 63% and 51% in AGREE II and AGREE REX, respectively), with a few domains showing slight improvements over the years. AGREE II "Scope and Purpose" (94%) and "Presentation Clarity" (99%) domains obtained the highest scores. The items related to "Stakeholder involvement," "Editorial independence," and "Clinical applicability" (AGREE REX) were fairly reported. Conversely, CPG lacks rigor in development (32% score, AGREE II), scarcely discusses the role of stakeholders, and provides deficient data on the implementation of recommendations (scores of 35% and 46% in AGREE II and AGREE REX, respectively). No differences in the quality of guidelines published by different developers or countries were observed (p > 0.05). CONCLUSION: Methodological weaknesses are common among guidelines addressing PAH treatment, especially regarding scientific rigor, stakeholders' values and preferences, and facilitators and barriers to implementability. Particular attention should be given to developing future guidelines.

Evaluation and systematic review of guidance documents for status epilepticus.

Guidance documents play a pivotal role in shaping the management of status epilepticus (SE). However, the methodological quality of these documents remains uncertain. In this systematic review, we comprehensively searched 12 literature and guideline databases to assess the quality of clinical practice guidelines and consensus statements related to SE management using the AGREE II methodology. Additionally, we summarized the associated recommendations. We identified a total of 14 clinical practice guidelines and 11 consensus statements spanning the period from 1993 to 2022. The median score for clarity of presentation was 71.8% (ranging from 15.3% to 91.7%), indicating generally good clarity. However, the aspect of editorial independence received poor ratings, with a median score of 32.1% (ranging from 0% to 83.3%). Notably, the 2016 guideline published by the American Epilepsy Society in Epilepsy (AES) received the highest overall scores. Across these guidance documents, there was consistency in the definition and diagnosis of SE. However, significant variability was observed in therapeutic recommendations, particularly in terms of the timing for adding or changing medications. The methodological approaches used in most SE guidance documents require improvement, and the disparities in recommendations highlight existing gaps in evidence. Enhanced methodological rigor results in increased standardization of the guideline, consequently augmenting its reference value. Given the urgency of SE as an emergency condition, it is imperative that these documents also address relevant management strategies before admission.

The quality of guidelines on the pancreatic perioperative enhanced recovery after surgery: a systematic quality appraisal using AGREE II instrument.

PURPOSE: To evaluate the quality of guidelines on the pancreatic perioperative enhanced recovery after surgery both domestically and internationally, providing reference and reference for clinical practice. METHODS: Systemically retrieved in the guideline websites, professional association websites and databases, such as up to date, BMJ Best Practice, PubMed, Embase, The Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), Wan Fang Data, China Science and Technology Journal Database(VIP), China Biology Medicine disc (CBMdisc), Medlive, Guidelines International Network(GIN), National Guideline Clearinghouse(NGC), National Institute for Health and Care Excellence(NICE), Registered Nurses Association of Ontario(RNAO), Scottish Intercollegiate Guidelines Network(SIGN), Joanna Briggs Institute Library(JBI), including guidelines and expert consensus on enhanced postsurgical recovery in pancreatic surgery published as of December 20, 2023. The Appraisal of Guidelines for Research and Evaluation II(AGREE II) tool was applied to evaluate the quality of the guidelines by four assessors. RESULTS: This study included seven guidelines, all of which were rated as Grade B in terms of quality, with ICC coefficients ranging from 0.752 to 0.884, indicating a high level of consistency. CONCLUSION: When formulating guidelines in the future, it is recommended to use AGREE II as a reference, emphasizing the standardization of the guideline development process and methods, fully considering patients' values and preferences, focusing on the applicability of the guidelines, and striving to create high-quality evidence-based recommendations.

How consistent are the key recommendations, and what is the quality of guidelines and expert consensus regarding paediatric cow's milk protein allergy?

The objective of this study was to assess the quality and consistency of recommendations in clinical practice guidelines (CPGs) and expert consensus on paediatric cow's milk protein allergy (CMPA) to serve as a foundation for future revisions and enhancements of clinical guidelines and consensus documents. We conducted a comprehensive literature search across several databases, including the Chinese Biomedical Literature Database (CBM), PubMed, Embase, Web of Science, UpToDate, ClinicalKey, DynaMed Plus and BMJ Best Practice. We spanned the search period from the inception of each database through October 1, 2023. We integrated subject headings (MeSH/Emtree) and keywords into the search strategy, used the search methodologies of existing literature and developed it in collaboration with a librarian. Two trained researchers independently conducted the literature screening and data extraction. We evaluated methodological quality and recommendations by using the Appraisal of Guidelines for Research & Evaluation II (AGREE II) and AGREE-Recommendations for Excellence (AGREE-REX) tools. Moreover, we compared and summarized key recommendations from high-quality CPGs. Our study included 27 CPGs and expert consensus documents on CMPA. Only four CPGs (14.8%) achieved a high-quality AGREE II rating. The four high-quality CPGs consistently provided recommendations for CMPA. The highest scoring domains for AGREE II were 'scope and purpose' (77 ± 12%) and 'clarity of presentation' (75 ± 22%). The lowest scoring domains were 'stakeholder involvement' (49 ± 21%), 'rigor of development' (34 ± 20%) and 'applicability' (12 ± 20%). Evaluation with AGREE-REX generally demonstrated low scores across its domains.   Conclusion: Recommendations within high-quality CPGs for the paediatric CMPA showed fundamental consistency. Nevertheless, the methodology and recommendation content of CPGs and the expert consensus exhibited low quality, thus indicating a substantial scope for enhancement. Guideline developers should rigorously follow the AGREE II and AGREE-REX standards in creating CPGs or expert consensuses to guarantee their clinical efficacy in managing paediatric CMPA. What is Known: • The quality of clinical practice guidelines and expert consensus on paediatric cow's milk protein allergy (CMPA) remains uncertain. • There is a lack of clarity regarding the consistency of crucial recommendations for CMPA management. What is New: • Improving the methodological quality of guidelines and consensus on CMPA requires greater emphasis on stakeholder engagement, rigorous development processes, and practical applicability. • The recommendations from four high-quality guidelines align. However, addressing clinical applicability, integrating values and preferences, and ensuring actionable implementation are critical to improving the quality of all guidelines.

An evaluation of the quality, suitability and impact on equity of clinical practice guidelines relevant to preterm birth for use in Aotearoa New Zealand.

BACKGROUND: Preterm birth is a leading cause of perinatal morbidity and mortality and a defining event for pregnant people, infants, and whanau (extended families). Recommendations have been made for a national preterm birth prevention initiative focusing on equity in Aotearoa New Zealand, including the development of a national best practice guide. An understanding of the number and quality of guidelines, and consideration of their suitability and impact on equity is required. METHODS: Guidelines were identified through a systematic literature search, search of professional bodies websites, and invitation to regional health services in Aotearoa New Zealand. Obstetric and midwifery clinical directors were invited to report on guideline use. Identified guidelines were appraised by a 23-member trans-disciplinary Review Panel; quantitatively using the AGREE-II instrument and qualitatively using modified ADAPTE questions. The quality of guidelines available but not in use was compared against those in current use, and by health services by level of maternity and neonatal care. Major themes affecting implementation and impact on equity were identified using Braun and Clarke methodology. RESULTS: A total of 235 guidelines were included for appraisal. Guidelines available but not in use by regional health services scored higher in quality than guidelines in current use (median domain score Rigour and Development 47.5 versus 18.8, p < 0.001, median domain score Overall Assessment 62.5 versus 44.4, p < 0.001). Guidelines in use by regional health services with tertiary maternity and neonatal services had higher median AGREE II scores in several domains, than those with secondary level services (median domain score Overall Assessment 50.0 versus 37.5, p < 0.001). Groups identified by the Review Panel as experiencing the greatest constraints and limitations to guideline implementation were rural, provincial, low socioeconomic, Maori, and Pacific populations. Identified themes to improve equity included a targeted approach to groups experiencing the least advantage; a culturally considered approach; nationally consistent guidance; and improved funding to support implementation of guideline recommendations. CONCLUSIONS: We have systematically identified and assessed guidelines on preterm birth. High-quality guidelines will inform a national best practice guide for use in Taonga Tuku Iho, a knowledge translation project for equity in preterm birth care and outcomes in Aotearoa.

Awake proning in patients with COVID-19-related hypoxemic acute respiratory failure: Endorsement by the Scandinavian Society of Anaesthesiology and Intensive Care Medicine.

BACKGROUND: Awake proning in spontaneously breathing patients with hypoxemic acute respiratory failure was applied during the coronavirus disease 2019 (COVID-19) pandemic to improve oxygenation while avoiding tracheal intubation. An updated systematic review and meta-analysis on the topic was published. METHODS: The Clinical practice committee (CPC) of the Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI) assessed the clinical practice guideline "Awake proning in patients with COVID-19-related hypoxemic acute respiratory failure: A rapid practice guideline" for possible endorsement. The Appraisal of Guidelines for REsearch and Evaluation (AGREE) II tool was used. RESULTS: Four out of six SSAI CPC members completed the appraisal. The individual domain totals were: Scope and Purpose 90%; Stakeholder Involvement 89%; Rigour of Development 74%; Clarity of Presentation 85%; Applicability 75%; Editorial Independence 98%; Overall Assessment 79%. CONCLUSION: The SSAI CPC endorses the clinical practice guideline "Awake proning in patients with COVID-19-related hypoxemic acute respiratory failure: A rapid practice guideline". This guideline serves as a useful decision aid for clinicians caring for critically ill patients with COVID-19-related acute hypoxemic respiratory failure and can be used to provide guidance on use of prone positioning in this group of patients.

ESAIC focused guideline for the use of cardiac biomarkers in perioperative risk evaluation: Endorsement by the Scandinavian Society of Anaesthesiology and Intensive Care Medicine.

BACKGROUND: The Clinical Practice Committee of the Scandinavian Society of Anaesthesiology and Intensive Care Medicine endorses the clinical practice guideline "ESAIC focused guideline for the use of cardiac biomarkers in perioperative risk evaluation." The guideline can provide guidance to Nordic anaesthesiologists on the perioperative use of cardiac biomarkers in patients undergoing non-cardiac surgery.

Reflections on an Evidence Review Process to Inform the Co-Design of a Toolkit for Supporting End-of-Life Care Planning With People With Intellectual Disabilities.

INTRODUCTION: There is growing recognition that healthcare inequalities faced by people with intellectual disabilities extend to their experiences at the end of life, resulting in calls for more inclusive research to help address these inequities. Our study aimed to address this through the co-design of a toolkit for supporting end-of-life care planning with people with intellectual disabilities. To inform the co-design process, we undertook an evidence review to identify existing tools, resources and approaches that were already being used in practice. METHODS: Our evidence review comprised three components: (i) a rapid scoping review of the academic literature, (ii) a desk-based search of the grey literature and (iii) an online survey to capture unpublished resources that were distributed to services, professionals, third-sector organisations and family members. A longlist of existing materials was appraised using an adapted version of the AGREE II instrument, resulting in a shortlist that was shared with the co-design team. RESULTS: The evidence review played a critical role in the co-design of a new toolkit of end-of-life care resources for people with intellectual disabilities. However, AGREE II proved to be limited for our purposes. CONCLUSIONS: The survey was particularly useful in helping us identify resources, tools and approaches in current use. We identified evidence review processes that served to support co-design team activities and elements that were more problematic. We argue that evidence review practices might be enhanced to better aid co-design activities in health and care research, particularly for studies involving people with intellectual disabilities. PATIENT OR PUBLIC CONTRIBUTION: This article reflects on an evidence review that was conducted as part of The Victoria and Stuart Project. People with intellectual disabilities were deeply involved at every stage of project design, delivery and dissemination. The project employed people with intellectual disabilities as members of the core research team. People with intellectual disabilities and family carers were members of the project co-design team and the project Advisory Group. The evidence review process itself was led by academic members of the research team with contributions from colleagues with intellectual disabilities via the Advisory Group and core research team. The findings from the evidence review were used by the co-design team to inform the development of an end-of-life care planning toolkit for people with intellectual disabilities.

Investigation of current guidelines for prescribing spectacles to children using a modified Delphi approach and the AGREE II tool.

PURPOSE: This study aimed to identify clinical guidelines that provide recommendations on prescribing refractive error correction in children, evaluate the overall quality of these guidelines using the Appraisal of Guidelines for REsearch and Evaluation II (AGREE II) tool and subsequently gain consensus on the prescribing recommendations from high-quality guidelines using the modified Delphi technique. METHODS: A comprehensive search for prescribing guidelines was conducted using databases and professional websites. The quality appraisal of eligible guidelines was undertaken by scoring the six AGREE II domains. Subsequently, the modified Delphi technique was used by 10 experts (sub-specialist optometrists, ophthalmologists and orthoptists) to gain consensus on the prescribing recommendation statements extracted from guidelines that had been identified as high quality. Three rounds were conducted in which agreement of these statements were scored using a 9-point Likert scale with a free-text option for any additional comments. RESULTS: Five eligible guidelines were identified. The AGREE II tool demonstrated that the guidelines varied substantially in quality, with only one guideline identified as being of high quality. A total of 168 prescribing statements were reviewed in the Delphi procedure. Of these, 95 statements reached expert consensus as being appropriate prescribing recommendations. CONCLUSION: There is significant scope for improving current guidelines for prescribing refractive error correction in children. We used the modified Delphi technique to find points of agreement on prescribing recommendations to support professionals prescribing refractive error correction in children. We recommend that further work is needed to address gaps in the guidelines.

A critical appraisal of clinical practice guidelines on surgical treatments for spinal metastasis.

PURPOSE: As an important treatment for spinal metastasis, surgery has strict applicable conditions. Although various organizations have formulated different guidelines on surgical treatment for spinal metastasis (SM), there are certain differences in the content, standardization and quality of the guidelines and it is necessary to make a critical appraisal of them. We aim to systematically review and appraise the current guidelines on surgical treatments of SM and summarize the related recommendations with the quality evaluation of supporting evidence, as to provide a reference for the standardization of surgical treatment plans, and help clinical front-line medical workers can make safe and effective clinical decisions faster. METHODS: We searched Pubmed, Web of Science, and Embase for three major databases and online guideline databases. According to certain inclusion and exclusion criteria, the latest guidelines on the surgical treatment of SM were sorted out. AGREE II was used to evaluated the guideline's quality, and we extracted and compared the recommended treatment content of each guideline with evaluating by the evidence-grading scale. RESULTS: Eight guidelines from 2013 to 2019 were included. Seven guidelines are comprehensive guidelines and one related to the reconstructive surgery of SM. Five guidelines were evaluated as "recommended," and three guidelines were evaluated as "recommended with modifications." Regarding the indications of surgery with SM, four guidelines, seven guidelines, seven guidelines, three guidelines and three guidelines recommended surgical treatment for patients with SM with intractable pain, mechanical instability, metastatic epidural spinal cord compression (MESCC), recurrent spinal metastasis (RSM), and survival predication, respectively. Regarding the surgical strategies, three guidelines recommended minimally invasive therapy but had strict indications. Six guidelines and five guidelines recommend palliative surgery and with receiving radiation therapy, respectively. For the aggressive surgery, only one guideline recommended to apply to patients in good general conditions who has isolated symptomatic SM. Regarding the surgical reconstructions, one guideline didn't recommend iliac bone graft and three guidelines recommended PMMA bone cement. CONCLUSION: Most of the guidelines do not provide clear criteria for surgical application and provide more of a basic framework. The level of evidence for these surgical recommendations ranges from LOE B to D, and almost all guidelines recommend vertebroplasty and kyphoplasty, but for palliative and more aggressive surgery, which recommended to personalize specific surgical strategies with multidisciplinary collaboration.

Evidence-based clinical practice guidelines for the management of acute ankle injuries according to: a PRISMA systematic review and quality appraisal with AGREE II.

BACKGROUND: Acute ankle injuries are commonly seen in emergency rooms, with significant social impact and potentially devastating consequences. While several clinical practice guidelines (CPGs) related to ankle injuries have been developed by various organizations, there is a lack of critical appraisal of them. The purpose of this systematic review is to identify and critically appraise evidence-based clinical practice guidelines (EB-CPGs) related to acute ankle injuries in adults. METHOD: We conducted searches in the Cochrane Library, MEDLINE, EMBASE databases, WHO, and reviewed 98 worldwide orthopedic association websites up until early 2023. Two authors independently applied the inclusion and exclusion criteria, and each evidence-based clinical practice guideline (EB-CPG) underwent independent critical appraisal of its content by all four authors using the Appraisal of Guidelines for REsearch and Evaluation (AGREE II) instrument. AGREE II scores for each domain were then calculated. RESULTS: This review included five evidence-based clinical practice guidelines. The mean scores for all six domains were as follows: Scope and Purpose (87.8%), Stakeholder Involvement (69.2%), Rigour of Development (72.5%), Clarity of Presentation (86.9%), Applicability (45.6%), and Editorial Independence (53.3%). CONCLUSION: The number of EB-CPGs related to ankle injuries are limited and the overall quality of the existing evidence-based clinical practice guidelines (EB-CPGs) for ankle injuries is not strong, with three of them being outdated. However, valuable guidance related to Ottawa rules, manual therapy, cryotherapy, functional supports, early ambulation, and rehabilitation has been highlighted. Challenges remain in areas such as monitoring and/or auditing criteria, consideration of the target population's views and preferences, and ensuring editorial independence. Future guidelines should prioritize improvements in these domains to enhance the quality and relevance of ankle injury management. SYSTEMATIC REVIEW: Systematic review.

Appraisal of clinical practice guidelines for salivary gland cancer management utilizing AGREE II instrument.

OBJECTIVE: Salivary gland cancers (SGC) are rare neoplasms which comprise 1-5 % of all head and neck cancers. SGCs can be managed by resection, radiosurgery, chemotherapy, or a combination of these. Our team appraised the quality of clinical practice guidelines (CPGs) for SGC treatment and management using the Appraisal of Guidelines for Research and Evaluation (AGREE-II) instrument. DATA SOURCES: PubMed, Scopus, & EMBASE were reviewed for CPGs regarding SGC management from database inception to January 1st, 2023. REVIEW METHODS: The AGREE-II instrument was used by 4 reviewers to independently evaluate guidelines. Domain scores were generated with a satisfactory threshold being >60 % - a "high" quality CPG required >4 satisfactory domains. Intraclass correlation coefficients (ICCs) were used, via R 4.2.1., to determine inter-reviewer variability. RESULTS: Literature review identified 645 articles, with six being included after applying inclusion and exclusion criteria. Of the six included articles, one CPG was "high" quality and 5 were "low" quality. The domains with the highest scores were "Editorial Independence" (72.57 ± 36.60) and "Clarity and Presentation" (63.19 ± 26.08), while the lowest were "Rigor of Development" (34.03 ± 30.63) and "Applicability" (30.21 ± 30.46). ICC scores for each domain ranged from 0.937 to 0.983, indicating a high level of inter-rater agreement. CONCLUSION: This study found that most CPGs for the treatment and management of SGC were of "low" quality, with only one guideline being considered "high" quality based on the standard set by the AGREE-II instrument. These findings indicate that there is a high level of variability and little standardization when it comes to the quality of CPGs.

AGREE II Evaluation of Clinical Practice Guidelines on Generalized Cancer Pain Management.

PURPOSE: While several clinical practice guidelines (CPGs) exist to guide clinical decision-making in patients with generalized cancer pain, to date there has been no comprehensive review of their quality. Our aim was to address this deficiency via the Appraisal of Guidelines for Research and Evaluation (AGREE II) tool. DESIGN: Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline-based systematic literature search followed by AGREE II appraisal of identified CPGs. METHODS: Embase, MEDLINE via PubMed, and Scopus were searched from inception to March 3, 2021, for relevant CPGs. Four authors (FR, AR, JN, JH) independently performed assessments and evaluations of the selected CPGs using the AGREE II instrument. Scaled domain percentage scores were calculated with 60% as the satisfactory quality threshold. Intraclass correlation coefficients (ICCs) were also calculated to assess interrater reliability. RESULTS: Twelve guidelines were selected for inclusion. Two guidelines were classified high quality, three guidelines as average quality, and seven as low quality. Domains of clarity of presentation (82.41% ± 18.20%) and scope and purpose (56.48% ± 30.59%) received the highest mean scores, while domains of applicability (44.53% ± 26.61%) and stakeholder involvement (36.81% ± 21.24%) received the lowest. ICCs showed high consistency between reviewers (range 0.85-0.98). CONCLUSIONS: Most CPGs for generalized cancer pain are of low quality. Future guidelines can be improved by better-defining scope and purpose, stakeholder involvement, rigor of development, applicability, and editorial independence during development. CLINICAL IMPLICATIONS: We hope these critiques improve the quality of published guidelines to promote an improved quality of care and method to measure quality outcomes.

Clinical practice guidelines in the management of pediatric foreign body aspiration and ingestion: a systematic evaluation using the AGREE II instrument.

PURPOSE: Several clinical practice guidelines (CPGs) have been produced to optimize the diagnosis and management of pediatric foreign body aspiration and ingestion. However, to date there have been no critical evaluations of their methodological rigor or quality. Herein, we address this need via the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. METHODS: A literature search of Embase, MEDLINE via PubMed, and Scopus was performed up until February 25, 2021. Identified CPGs were then assessed by four independent reviewers trained in AGREE II. A scaled domain score of >60% was indicated as satisfactory quality. Intraclass correlation coefficients (ICC) were calculated to assess inter-reviewer agreement. RESULTS: 11 guidelines were assessed with only one being classified as high quality and others being either average (two) or low quality (eight). Domain 4 (clarity of presentation) achieved the highest mean score (66.41 ± 13.33%), while domain 5 (applicability) achieved the lowest score (10.80 ± 10.37%). ICC analysis revealed generally strong agreement between reviewers with a range of 0.60-0.98. CONCLUSION: Quality appraisal using the AGREE II instrument suggests that the methodologic rigor and quality of current guidelines for the diagnosis and management of pediatric foreign body aspiration and ingestion need significant improvement.

Stability-indicating green HPLC method for fixed-dose tablets containing remogliflozin etabonate and teneligliptin: an AQbD approach.

BACKGROUND: In June 2021, the Central Drug Standards Control Organization approved a fixed-dose combination tablet containing remogliflozin etabonate (100 mg) and teneligliptin (10 mg) to manage type II diabetes. OBJECTIVE: This study aims to develop a stability-indicating RP-HPLC method for quantifying remogliflozin etabonate and teneligliptin in tablet formulations via analytical quality by design (AQbD) principles. METHODS: Risk assessment, Plackett-Burman design, and central composite design were employed to understand the impact of independent variables on critical analytical attributes. The stationary phase was a HyperClone BDS C18 column, and the mobile phase consisted of acetonitrile and phosphate buffer (20 mM, pH 5) at a 45:55% (v/v) ratio. RESULTS: The method, validated per ICH Q2 (R1), resulted in retention times of 3.395 and 12.308 min for teneligliptin and remogliflozin etabonate, respectively. Forced degradation studies confirmed robustness, with clear peak separation and no interference from degradation products. The AGREE score of 0.65 supports its green applicability for tablet analysis in quality control. CONCLUSION: The AQbD-assisted RP-HPLC method developed in this study offers environmental friendliness, efficient separation with well-defined peaks, and simple mobile phase combination.

The Use of Ultra-Fast Gas Chromatography for Fingerprinting-Based Classification of Zweigelt and Rondo Wines with Regard to Grape Variety and Type of Malolactic Fermentation Combined with Greenness and Practicality Assessment.

In food authentication, it is important to compare different analytical procedures and select the best method. The aim of this study was to determine the fingerprints of Zweigelt and Rondo wines through headspace analysis using ultra-fast gas chromatography (ultra-fast GC) and to compare the effectiveness of this approach at classifying wines based on grape variety and type of malolactic fermentation (MLF) as well as its greenness and practicality with three other chromatographic methods such as headspace solid-phase microextraction/gas chromatography-mass spectrometry with carboxen-polydimethylosiloxane fiber (SPME/GC-MS with CAR/PDMS fiber), headspace solid-phase microextraction/gas chromatography-mass spectrometry with polyacrylate fiber (SPME/GC-MS with PA fiber), and ultra performance liquid chromatography-photodiode array detector-tandem mass spectrometry (UPLC-PDA-MS/MS). Principal Component Analysis (PCA) revealed that fingerprints obtained using all four chromatographic methods were suitable for classification using machine learning (ML). Random Forest (RF) and Support Vector Machines (SVM) yielded accuracies of at least 99% in the varietal classification of Zweigelt and Rondo wines and therefore proved suitable for robust fingerprinting-based Quality Assurance/Quality Control (QA/QC) procedures. In the case of wine classification by the type of MLF, the classifiers performed slightly worse, with the poorest accuracy of 91% for SVM and SPME/GC-MS with CAR/PDMS fiber, and no less than 93% for the other methods. Ultra-fast GC is the greenest and UPLC-PDA-MS/MS is the most practical of the four chromatographic methods.

Validated green and white RP-HPLC method for the estimation of Zolmitriptan in marketed dosage form.

OBJECTIVE: To develop and validate a rapid, accurate, economical, effective and greenery RP-HPLC method for the determination of Zolmitriptan in tablet dosage form. MATERIAL AND METHOD: RP-HPLC method was developed using Luna (C18) (4.6×250mm, 5µm) column and Sodium phosphate buffer (pH 4.7): Methanol [75: 25, v/v] was used as mobile phase at a flow rate of 1.0mL/min. The detection was carried out at 227nm. Further, eco-friendliness, productivity and performance of the optimized analytical method were assessed by green and white tools. RESULTS: The retention time of Zolmitriptan was found to be 3.25min with acceptable chromatographic parameters. The optimized RP-HPLC method was more eco-friendly, efficient, throughput and practicable than the reported methods as confirmed by AES, AGREE, GAPI and RGB tools. Further, the proposed analytical method showed all the validation parameters within the acceptance limit of ICH Q2 R1 guidelines. The linear regression analysis indicated a good linear response in the 10 to 120µg/mL concentration range with R2 of 0.99998. The percentage content and percentage assay of Zolmitriptan in Zomig-5mg tablet was found to be 103.36±0.356% and 97.86±0.693%. CONCLUSION: The developed and validated method has several advantages compared to the reported HPLC methods and is useful in the systematic analysis of Zolmitriptan in its dosage form.

Exome and genome sequencing for rare genetic disease diagnosis: A scoping review and critical appraisal of clinical guidance documents produced by genetics professional organizations.

PURPOSE: Exome and genome sequencing have rapidly transitioned from research methods to widely used clinical tests for diagnosing rare genetic diseases. We sought to synthesize the topics covered and appraise the development processes of clinical guidance documents generated by genetics professional organizations. METHODS: We conducted a scoping review of guidance documents published since 2010, systematically identified in peer-reviewed and gray literature, using established methods and reporting guidelines. We coded verbatim recommendations by topic using content analysis and critically appraised documents using the Appraisal of Guidelines Research and Evaluation (AGREE) II tool. RESULTS: We identified 30 guidance documents produced by 8 organizations (2012-2022), yielding 611 recommendations covering 21 topics. The most common topic related to findings beyond the primary testing indication. Mean AGREE II scores were low across all 6 quality domains; scores for items related to rigor of development were among the lowest. More recently published documents generally received higher scores. CONCLUSION: Guidance documents included a broad range of recommendations but were of low quality, particularly in their rigor of development. Developers should consider using tools such as AGREE II and basing recommendations on living knowledge syntheses to improve guidance development in this evolving space.

A systematic review of paediatric neurogenic lower urinary tract dysfunction guidelines using the Appraisal of Guidelines and Research Evaluation (AGREE) II instrument.

OBJECTIVE: To examine and critique current international clinical practice guidelines (CPGs) on management of paediatric neurogenic lower urinary tract dysfunction (NLUTD) and assess the applicability of these guidelines to clinical practice. MATERIALS AND METHODS: We conducted a systematic review of all CPGs on NLUTD published in English from the year 2010 to 2022. Six reviewers independently used the Appraisal of Guidelines and Research Evaluation (AGREE) II instrument to appraise all eligible CPGs. This instrument is comprised of 23 items organised into six quality domains. The scores for each item and domain were tabulated for each reviewer and interrater reliability was assessed for each domain using the intraclass correlation coefficient (ICC). RESULTS: Six CPGs were appraised and these included: National Institute for Health and Care Excellence (NICE), European Society for Paediatric Urology, International Children's Continence Society, Irish, Spina Bifida Association (SBA), and International Brazilian Journal of Urology guidelines. They had high mean standardised scores in the domain on 'scope and purpose' and 'clarity of presentation' but had low scores in the domain of 'applicability'. The top three CPGs based on overall score were the NICE, Irish and SBA guidelines and the reviewers had high degree of interrater reliability (ICC 0.912, P < 0.001). The mean scores in various domains for the top three guidelines were 95.8 (scope and purpose), 87.5 (stakeholder involvement), 69.1 (rigour of development), 94.0 (clarity of presentation), 68.4 (applicability), and 59.7 (editorial independence). The diagnostic and treatment recommendations of the top three guidelines were presented. CONCLUSION: The existing CPGs on paediatric NLUTD provide high-quality evidence based recommendations. The NICE, Irish and SBA guidelines were the top three CPGs identified. They scored high on most domains except applicability and editorial independence. These domains need to be considered for future updates to improve the utility.

Quality and consistency of clinical practice guideline recommendations for PET/CT and PET: a systematic appraisal.

OBJECTIVES: To systematically appraise the methodologies used for guidelines for positron emission tomography (PET) imaging and to compare the consistency of these recommendations. METHODS: We searched PubMed, EMBASE, four guideline databases, and Google Scholar to identify evidence-based clinical practice guidelines pertaining to the use of PET, PET/computed tomography (CT), or PET/magnetic resonance in routine practice. We assessed the quality of each guideline using the Appraisal of Guidelines for Research and Evaluation II instrument and compared recommendations regarding indications for 18F-fluorodeoxyglucose (FDG) PET/CT. RESULTS: Thirty-five guidelines for PET imaging, published between 2008 and 2021, were included. These guidelines performed well in the domains of scope and purpose (median 80.6%, inter-quartile range [IQR] 77.8-83.3%) and clarity of presentation (median 75%, IQR 69.4-83.3%), but poorly in applicability (median 27.1%, IQR 22.9-37.5%). Recommendations for 48 indications in 13 cancers were compared. Considerable inconsistencies in the direction of whether to support the use of FDG PET/CT were observed in 10 (20.1%) indications pertaining to 8 cancer types: head and neck cancer (treatment response assessment), colorectal cancer (staging in patients with stages I-III disease), esophageal cancer (staging), breast cancer (restaging and treatment response assessment), cervical cancer (staging in patients with stage < IB2 disease and treatment response assessment), ovarian cancer (restaging), pancreatic cancer (diagnosis), and sarcoma (treatment response assessment). CONCLUSIONS: Current guidelines for PET imaging vary in methodological quality and provided considerably inconsistent recommendations. Efforts are needed to improve adherence to guideline development methodologies, to synthesis high-quality evidence, and to adopt standard terminologies. PROTOCOL REGISTRATION NUMBER: PROSPERO CRD42020184965. CLINICAL RELEVANCE STATEMENT: Guidelines for PET imaging provide considerably inconsistent recommendations and vary in methodological quality. It is suggested that clinicians be critical of these recommendations when applying them in practice, that guideline developers adopt more rigorous development methodologies, and that researchers prioritize research gaps identified by current guidelines. KEY POINTS: • PET guidelines vary in methodological quality and provided inconsistent recommendations. Efforts are needed to improve methodologies, synthesize high-quality evidence, and standardize terminologies. • Among six domains of methodological quality assessed by the AGREE II tool, guidelines for PET imaging performed well in scope and purpose (median 80.6%, inter-quartile range 77.8-83.3%) and clarity of presentation (75%, 69.4-83.3%), but poorly in applicability (27.1%, 22.9-37.5%). • Among the 48 recommendations (for 13 cancer types) compared, conflicts in the direction of whether to support FDG PET/CT use were observed in 10 (20.1%), for 8 cancer types (i.e., head and neck, colorectal, esophageal, breast, cervical, ovarian, pancreatic, and sarcoma).