High-quality Guidelines Research Articles

Accessibility, inclusivity, and implementation of COVID-19 clinical management guidelines early in the pandemic: a global survey

Background: With a rapidly changing evidence base, high-quality clinical management guidelines (CMGs) are key tools for aiding clinical decision making and increasing access to best available evidence-based care. A rapid review of COVID-19 CMGs found most lacked methodological rigour, overlooked at-risk populations, and varied in treatment recommendations. Furthermore, social science literature highlights the complexity of implementing guidelines in local contexts where they were not developed and the resulting potential to compound health inequities. This study aimed to evaluate access to, inclusivity of, and implementation of COVID-19 CMGs in different settings. Methods: A cross-sectional survey of clinicians worldwide was conducted from 15th June to 20th July 2020, to explore access to and implementation of COVID-19 CMGs, and treatment and supportive care recommendations provided. Data on accessibility, inclusivity, and implementation of CMGs were analysed by geographic location. Results: 76 clinicians from 27 countries responded: 82% from high-income countries, 17% from lower middle-income countries (LMICs). Most respondents reported access to COVID-19 CMGs and confidence in their implementation. However, many respondents, particularly from LMICs, reported barriers to implementation, including limited access to treatment and equipment. Only 20% of respondents reported having access to CMGs covering care for children, 25% for pregnant women, and 50% for older adults (>65 years). Identified themes were for CMGs to include recommendations for at-risk populations and settings, include supportive care guidance, and be updated as evidence emerges, and for clinicians to have training and access to recommended treatments to support implementation. Conclusion: Our findings highlight important gaps in COVID-19 CMG development and implementation challenges during a pandemic, particularly affecting at-risk populations and lower resourced settings. This study identifies an urgent need for an improved CMG development framework that is inclusive and adaptable to emerging evidence and considers contextual implementation support, to improve access to evidence-based care globally.

An International Needs Assessment Survey of Guideline Developers Demonstrates Variability in Resources and Challenges to Collaboration between Organizations.

The development of rigorous, high-quality clinical guidelines increases the need for resources and skilled personnel within guideline-producing organizations. While collaboration between organizations provides a unique opportunity to pool resources and save time and effort, the collaboration presents its own unique challenges. To assess the perceived needs and current challenges of guideline producers worldwide related to guideline development and collaboration efforts. Survey questions were developed by the Guidelines International Network and the US GRADE Network, pilot-tested among attendees of a guideline development workshop, and disseminated electronically using convenience and snowball sampling methods. A total of 171 respondents representing 30 countries and more than 112 unique organizations were included in this analysis. The survey included free-response, multiple-choice, and seven-point Likert-scale questions. Questions assessed respondents' perceived value of guidelines, resource availability and needs, guideline development processes, and collaboration efforts of their organization. Time required to develop high-quality systematic reviews and guidelines was the most relevant need (median=7; IQR=5.5-7). In-house resources to conduct literature searches (median=4; IQR=3-6) and the resources to develop rigorous guidelines rapidly (median=4; IQR=2-5) were perceived as the least available resources. Difficulties reconciling differences in guideline methodology (median=6; IQR=4-7) and the time required to establish collaborative agreements (median=6; IQR=5-6) were the most relevant barriers to collaboration between organizations. Results also indicated a general need for improvement in conflict of interest (COI) disclosure policies. The survey identified organizational challenges in supporting rigorous guideline development, including the time, resources, and personnel required. Connecting guideline developers to existing databases of high-quality systematic reviews and the use of freely available online platforms may facilitate guideline development. Guideline-producing organizations may also consider allocating resources to hiring or training personnel with expertise in systematic review methodologies or utilizing resources more effectively by establishing collaborations with other organizations.

Extra-Colonic Malignancy in Inflammatory Bowel Disease: a Paucity of Recommendations with Weak Evidence.

Little data is available surrounding societal recommendations regarding extra-colonic malignancy in patients with inflammatory bowel disease (IBD). As a result, we systematically analyzed these international guidelines to assess their overall quality as well as their adherence to standards for high-quality practice guidelines. A systematic search was performed in multiple databases to identify all guidelines pertaining to extra-colonic malignancy in IBD in April 2020. All guidelines were reviewed for conflicts of interest (COI)/funding, recommendation quality and strength, external document review, use of patient representation, and plans for update-as per Institute of Medicine standards. In addition, recommendations were compared between guidelines/societies. Statistical analysis was conducted using R. A total of 11 recommendations on extra-colonic malignancy in IBD were put forth by 5 guidelines/societies. Zero percent of recommendations were found to be based on high-quality evidence, 36.4% of recommendations on moderate-quality evidence, and 63.6% of recommendations on low-quality evidence. 9.1% were strong recommendations, 0% were weak/conditional recommendations, and 90.9% of recommendations did not provide a strength. No guideline included patient representation or had plans for future update of their recommendations. There is a consistent lack of high-quality recommendations for extra-colonic malignancy in IBD across different societal guidelines. The need for high-quality studies to improve the strength of recommendations is eminent, as this will ultimately lead to high-quality patient care.

Prevention of Tuberculosis Reactivation


 It is not known if screening for latent tuberculosis infection (LTBI) is useful for reducing the risk of tuberculosis reactivation among people at risk (no evidence was found).
 In people with LTBI, providing treatment for the latent infection may be helpful for preventing the development of active tuberculosis disease. (In addition, LTBI treatments do not appear to increase the risk for hepatotoxicity.) Treatment effectiveness may depend on the specific LTBI treatment regimen used.
 For people at an increased risk for tuberculosis ― including those from areas with high rates of tuberculosis ― guidelines recommend screening and treatment for LTBI, as this may help prevent TB reactivation. Treatment is recommended for those who are 65 years old or younger and with a positive LTBI result (recommendation from 1 high-quality guideline).

Methodological and reporting quality of pediatric clinical practice guidelines: a systematic review.

BackgroundPediatric clinical practice guidelines (CPGs) can provide systematically developed clinical recommendations to guide pediatric clinicians and patients making decisions. This study aims to assess the methodological and reporting quality of pediatric CPGs.MethodsWe performed a systematic literature search of MEDLINE from 1 January 1990 to 2 April 2020 to identify pediatric CPGs published in the ten highest-impact pediatric journals and four highest-impact general medical journals. Two researchers evaluated the methodological and reporting quality of pediatric CPGs using the Appraisal of Guidelines Research and Evaluation (AGREE) II instrument and Reporting Items for Practice Guidelines in Health care (RIGHT) checklist. We calculated the mean AGREE II scores and compliance to RIGHT overall, and for each domain of the respective tools. We compared the methodological and reporting quality by different time periods and calculated the correlation between the AGREE II score and compliance to RIGHT.ResultsA total of 159 pediatric CPGs were identified. The mean (± standard deviation) scores for the six domains of the AGREE II instrument were as follows: scope and purpose 74.5%±14.2%, stakeholder involvement 42.7%±16.2%, rigour of development 18.7%±14.2%, clarity of presentation 56.5%±17.0%, applicability 8.9%±12.7% and editorial independence 25.2%±34.6%. The overall assessment score was 37.8%±12.4%. The mean compliance to RIGHT items in the seven domains of the checklist were: basic information 73.6%±14.9%, background 67.1%±16.4%, evidence 32.7%±27.2%, recommendations 32.4%±22.5%, review and quality assurance 22.9%±40.4%, funding and declaration and management of interests 24.1%±36.3%, and other information 45.3%±30.1%. The overall reporting rate for RIGHT was 46.4%±16.6%. Both the AGREE II scores and RIGHT reporting rates increased over time. We found a high positive correlation between AGREE II scores and RIGHT reporting compliance (r=0.645, P<0.001).DiscussionThe methodological and reporting quality of pediatric CPGs have improved over time, but remain still suboptimal and needs to be further improved. An international database of pediatric guidelines is urgently needed to identify and promote high-quality guidelines and guide clinical practice in pediatrics.

Weight management across preconception, pregnancy, and postpartum: A systematic review and quality appraisal of international clinical practice guidelines.

This systematic review and quality appraisal evaluated clinical practice guidelines (CPGs) for weight management and weight-related behaviors across preconception, pregnancy, and postpartum. CPGs published in English were identified from research and guideline-specific databases between 2010 and 2019. Recommendations were categorized into weight (body mass index screening, weight loss, weight gain prevention, and gestational weight gain), diet, food safety, physical activity, and behavioral strategies. Three independent appraisers assessed CPG quality using the Appraisal of Guidelines Research and Evaluation II instrument. Twenty-two CPGs were included across preconception (n= 2), pregnancy (n=8), postpartum (n=2), or a combination (n=10). Overall, 45% of CPGs were appraised as poor quality, 32% as moderate, and 23% as high. Evaluation of body mass index and supplementation recommendations were most common across CPGs, alongside secondary weight management recommendations for women with obesity in fewer CPGs. Accompanying recommendations for diet, physical activity, and behavior were highly variable between guidelines. We report significant ambiguity in existing guidance and an absence of important considerations, including targeting weight gain prevention and limiting excess gestational weight gain. Results emphasize the need for development of robust, comprehensive, and high quality guidelines on healthy lifestyle and weight management across these formative reproductive life stages.

Palonosetron for Patients Undergoing High or Moderate Emetogenic Chemotherapy

&#x0D; This report identified high to moderate quality evidence from clinical studies and economic evaluations, as well as high-quality guidelines regarding the use of palonosetron in the prevention of chemotherapy-induced nausea and vomiting in adult and pediatric patients receiving different emetogenic chemotherapies. Interpretations of the findings should be taken with caution because of the presence of some identified limitations in both clinical and economic evidence.&#x0D; In adult patients receiving high emetogenic chemotherapy, a fixed antiemetic combination of netupitant and palonosetron (NEPA) plus dexamethasone demonstrated noninferiority relative to a triple regimen of granisetron-aprepitant-dexamethasone. Similarly, palonosetron had similar efficacy compared to granisetron with the co-administration of neurokinin 1 receptor antagonist (e.g., aprepitant or fosaprepitant) and dexamethasone. However, in the absence of aprepitant, a 2-drug combination of palonosetron-dexamethasone appeared to be significantly more effective than granisetron-dexamethasone for the prevention of both acute and delayed emesis.&#x0D; In adult patients receiving moderate emetogenic chemotherapy, palonosetron plus dexamethasone was found to be noninferior compared with ondansetron plus dexamethasone. Similar efficacy was also observed between palonosetron plus dexamethasone and transdermal granisetron plus dexamethasone.&#x0D; In a mixed population of adult patients receiving high or moderate emetogenic chemotherapy, a palonosetron regimen appeared to have greater efficacy than ondansetron for delayed emesis. The efficacy of triple regimen of palonosetron-aprepitant-dexamethasone and granisetron-aprepitant-dexamethasone was comparable at all phases.&#x0D; In pediatric patients receiving high emetogenic chemotherapy, palonosetron plus dexamethasone had similar efficacy compared with ondansetron plus dexamethasone in the acute phase, but was more effective in delayed and overall phases of chemotherapy-induced nausea and vomiting.&#x0D; In a mixed population of pediatric patients receiving high or moderate emetogenic chemotherapy, palonosetron plus dexamethasone was noninferior to ondansetron plus dexamethasone.&#x0D; There were no significant differences between palonosetron and ondansetron or between palonosetron and granisetron treatment regimens in adverse events or quality of life.&#x0D; A cost-utility analysis revealed that NEPA plus dexamethasone was dominant (i.e., cost less, more effective) relative to granisetron-aprepitant-dexamethasone and ondansetron-aprepitant or fosaprepitant-dexamethasone in adult patients receiving high emetogenic chemotherapy. In contrast, double or triple regimens of palonosetron was not cost-effective compared to granisetron regimens, mainly due to large difference in price and small quality-adjusted life-years gained. These economic evaluations may not be applicable to the Canadian context.&#x0D; The identified high-quality guidelines have recommendations on the use of specific antiemetic regimens for adult and pediatric patients receiving high emetogenic chemotherapy or moderate emetogenic chemotherapy and suggest that palonosetron may be offered as an alternative to other 5-hydroxytryptamine-3 receptor antagonists and that 1 5-hydroxytryptamine-3 receptor antagonist is not preferred over another based on the available evidence.&#x0D;

Application of AGREEⅡ in evaluating quality of esophageal cancer screening practice guidelines

High-quality clinical practice guidelines are of great significance for standardizing the clinical diagnosis and treatment process and improving the overall quality of health care. The Appraisal of Guidelines for Research & Evaluation InstrumentⅡ (AGREEⅡ) is one of the recognized tools for the evaluation of the quality of clinical practice guidelines. It has been translated into Chinese and is widely used in guideline formulation and quality evaluation. This article intends to take the comparatively high-quality clinical practice guidelines in the field of esophageal cancer screening in China, i.e. "Expert Consensus on Early Esophageal Cancer and Precancerous Lesion Screening in China (2019, Xinxiang)" as an example, to interpret the use of AGREEⅡ item by item, which might provide a reference for medical and health workers to better understand and use the assessment tool.

Development and validation of a tool to appraise guidelines on SARS-CoV-2 infection control strategies in healthcare workers

BackgroundClinical guidelines on infection control strategies in healthcare workers (HCWs) play an important role in protecting them during the severe acute respiratory syndrome coronavirus 2 pandemic. Poorly constructed guidelines that are incomprehensive and/or ambiguous may compromise HCWs’ safety. ObjectiveThe objective of this study was to develop and validate a tool to appraise guidelines on infection control strategies in HCWs based on the guidelines published early in the coronavirus disease 2019 pandemic. Design, setting, and outcomesA three-stage, web-based, Delphi consensus-building process among a panel of diverse HCWs and healthcare managers was performed. The tool was validated by appraising 40 international, specialty-specific, and procedure-specific guidelines along with national guidelines from countries with a wide range of gross national income. ResultsOverall consensus (≥75%) was reached at the end of three rounds for all six domains included in the tool. The Delphi panel recommended an ideal infection control guideline should encompass six domains: general characteristics (domain 1), engineering recommendations (domain 2), personal protective equipment (PPE) use (domain 3), and administrative aspects (domain 4-6) of infection control. The appraisal tool performed well across the six domains, and the inter-rater agreement was excellent for the 40 guidelines. All included guidelines performed relatively better in domains 1–3 than in domains 4–6, and this was more evident in guidelines originating from lower income countries. ConclusionThe guideline appraisal tool was robust and easy to use. Engineering recommendations aspects of infection control, administrative measures that promote optimal PPE use, and HCW wellbeing were generally lacking in assessed guidelines. This tool may enable health systems to adopt high-quality HCW infection control guidelines during the severe acute respiratory syndrome coronavirus 2 pandemic and may also provide a framework for future guideline development.

IgA Vasculitis in Adults: a Rare yet Challenging Disease.

IgA vasculitis (IgAV) is a rare and poorly understood systemic vasculitis in adults. Its diagnosis and treatment remain a challenge. Herein, we review the clinical manifestations, diagnosis, management, and prognosis of IgAV in adults. The clinical course of IgAV in adults appears to be different from pediatric IgAV, especially due to its higher risk of evolving into end-stage renal disease. Rising awareness and interest in adult-onset IgA vasculitis has resulted in recent increasing number of publications on different treatment experiences. However, there is still controversy over the role of glucocorticoid (GC) and different immunosuppressive therapies such as cyclophosphamide, rituximab, and mychophenolate mofetil for more severe IgAV. Data regarding potential benefits of targeting the mucosal immune system, toll-like receptors, complements, and tyrosine kinase inhibitors in the treatment of IgA nephropathy are emerging. High quality evidence or guidelines in the treatment of severe IgAV are lacking and there is still a great need for controlled trials.

Endorsement of clinical practice guidelines: Criteria from the College of Family Physicians of Canada.

To refine the process for endorsement of guidelines and establish the expectations of the College of Family Physicians of Canada (CFPC) regarding the quality and relevance of clinical practice guidelines targeting family physicians and their patients. Initially, a group of 6 CFPC staff and selected College members reviewed the previous process for endorsement with the aim of providing a new direction, if needed. The work was then assumed by the Guideline and Knowledge Translation Expert Working Group, a purposefully selected group of 9 family physicians from across Canada with expertise in research, evidence, guidelines, knowledge translation, and continuing professional development and education. The initial task force reviewed the endorsement process and identified areas for improvement. A draft new process and core criteria for high-quality guidelines were developed. This was approved by the CFPC board. A Guideline and Knowledge Translation Expert Working Group was then formed to further refine the process and the criteria. Multiple resources were used to inform the criteria. The Guideline and Knowledge Translation Expert Working Group will manage the endorsement process of external submitted guidelines, as well as provide high-level guidance to the CFPC regarding in-house guidelines and continuing professional development content. This article provides the expectations of the CFPC regarding clinical practice guidelines and describes in detail the process and criteria for endorsement. Key principles include family physician involvement and guideline funding unlikely to introduce bias, with most criteria falling under 4 themed areas: relation to family medicine, CFPC values, patient engagement and decision making, and scientific rigour. The Guideline and Knowledge Translation Expert Working Group will report to the CFPC board at least once a year. It is hoped that this fully transparent process and these criteria will help advance the quality and standards of clinical practice guideline production in Canada. A comprehensive but reasonable list has been provided that reflects the best standards and recommendations and is consistent with the CFPC's values while recognizing the landscape of guideline development for its national partners and colleagues. As with all processes, careful consideration and evaluation will be essential.

Timing of umbilical cord clamping for preterm infants in low-and-middle-income countries: A survey of current practice

IntroductionThe optimal timing of umbilical cord clamping in preterm infants has been contested for years. Previously, it was common practice to clamp the cord immediately after birth. There is now high-quality evidence that delayed cord clamping (DCC) (>60 seconds) reduces mortality in preterm infants by allowing placental transfusion. However, it is unclear how well DCC has been implemented into practice. This study aims to assess current practice of timing of cord clamping for both stable and unstable preterm infants in LMICs, where rates of preterm birth and neonatal mortality are high and where there is the potential to see the greatest benefit from implementation of DCC. MethodsAn online survey was created and, following user-testing, circulated to maternity workers in LMICs via The International Federation of Gynaecology and Obstetrics (FIGO), social media and other existing collaborators. Analyses were conducted using SPSS. Results70 responses were received across 10 LMICs. 42/70 (60%) participants reported practising DCC for stable preterm infants, compared to only 4/70 (6%) for unstable infants. For stable infants, 22/42 (52%) of those who practised DCC gave their main reason as being “recommended by guidelines”. 13/70 (19%) participants said they didn’t follow any guidelines for the timing of cord clamping. Only 25/70 (36%) were aware of guidelines for cord clamping in their hospitals, and 9/70 (13%) were aware of related quality improvement projects (QIPs). DiscussionDespite evidence to support the use of DCC, timing of cord clamping in LMICs is variable. Unstable infants requiring stabilisation could benefit most from placental transfusion, yet few respondents practised DCC and few hospitals had QIPs in place. Higher-quality guidelines and training could increase implementation of DCC, and development of affordable equipment to allow bedside resuscitation with the cord intact could aid in reducing neonatal mortality.

Published randomized controlled trials of surveillance in cancer patients - a systematic review.

With solid tumor cancer survivorship increasing, the number of patients requiring post-treatment surveillance also continues to increase. This highlights the need for evidence-based cancer surveillance guidelines. Ideally, these guidelines would be based on combined high-quality data from randomized controlled trials (RCTs). We present a systematic review of published cancer surveillance RCTs in which we sought to determine the feasibility of data pooling for guideline development.We carried out a systematic search of medical databases for RCTs in which adult patients with solid tumors that had undergone surgical resection with curative intent and had no metastatic disease at presentation, were randomized to different surveillance regimens that assessed effectiveness on overall survival (OS). We extracted study characteristics and primary and secondary outcomes, and assessed risk of bias and validity of evidence with standardized checklist tools.Our search yielded 32,216 articles for review and 18 distinct RCTs were included in the systematic review. The 18 trials resulted in 23 comparisons of surveillance regimens. There was a highlevel of variation between RCTs, including the study populations evaluated, interventions assessed and follow-up periods for the primary outcome. Most studies evaluated colorectal cancer patients (11/18, [61%]). The risk of bias and validity of evidence were variable and inconsistent across studies.This review demonstrated that there is tremendous heterogeneity among RCTs that evaluate effectiveness of different postoperative surveillance regimens in cancer patients, rendering the consolidation of data to inform high-quality cancer surveillance guidelines unfeasible. Future RCTs in the field should focus on consistent methodology and primary outcome definition.

What does it take to facilitate the integration of clinical practice guidelines for the management of low back pain into practice? Part 2: A strategic plan to activate dissemination.

Low back pain (LBP) is the leading cause of disability worldwide among all musculoskeletal disorders despite an intense focus in research efforts. Researchers and decision makers have produced multiple clinical practice guidelines for the rehabilitation of LBP, which contain specific recommendations for clinicians. Adherence to these recommendations may have several benefits, such as improving the quality of care for patients living with LBP, by ensuring that the best evidence-based care is being delivered. However, clinicians' adherence to recommendations from these guidelines is low and numerous implementation barriers and challenges, such as complexity of information and sheer volume of guidelines have been documented. In a previous paper, we performed a systematic review of the literature to identify high-quality clinical practice guidelines on the management of LBP, and developed a concise yet comprehensive infographic that summarizes the recommendations from these guidelines. Considering the wealth of scientific evidence, passive dissemination alone of this research knowledge is likely to have limitations to help clinicians implement these recommendations into routine practice. Thus, an active and engaging dissemination strategy, aimed at improving the implementation and integration of specific recommendations into practice is warranted. In this paper, we argue that a conceptual framework, such as the theoretical domains framework, could facilitate the implementation of these recommendations into clinical practice. Specifically, we present a systematic approach that could serve to guide the development of a theory-informed knowledge translation intervention as a means to overcome implementation challenges in rehabilitation of LBP.

Quality of clinical practice guidelines for the management of hypertension in six Southeast Asian countries

ABSTRACT Background: The endemic of hypertension along with high prevalence of uncontrolled hypertension in Southeast Asia indicates an important role for high-quality clinical practice guidelines (CPGs) to optimize the management of hypertension. However, there was no reported quality appraisal of the CPGs for the management of hypertension in Southeast Asia. Objective: This study aimed to evaluate methodological quality across the CPGs for the management of hypertension in Southeast Asia with a validated quality appraisal tool. Methods: The CPGs for the management of hypertension in Southeast Asia were retrieved from the websites of the Ministry of Health or cardiovascular specialty societies of the individual countries of Southeast Asia. Two reviewers with academic backgrounds independently appraised the methodological quality of all the included CPGs using the Appraisal of Guideline ResEarch and Evaluation (AGREE II) instrument. Results: Six CPGs were identified, each of them from Thailand, Malaysia, Indonesia, Brunei, Singapore, and Vietnam. The highest-scoring quality domain was ‘clarity of presentation’ (mean=78.7 ± 14.6%), whereas the lowest-scoring quality domains were ‘applicability’ and ‘editorial independence’ (mean=8.4 ± 6.0% and mean=8.3 ± 18.6%, respectively). Except for the CPG originated from Malaysia which was “recommended“ for use in practice (standardized score for three domains was ≥50.0%), the remaining five CPGs were “weakly recommended” for use in practice (standardized score for one to two domains was ≥50%). Conclusion: More efforts are needed to improve the quality of the developed CPGs for the management of hypertension in Southeast Asia.

Quality Indicators for the Diagnosis and Management of Sudden Sensorineural Hearing Loss.

Sudden sensorineural hearing loss (SSNHL) is an ideal entity for quality indicator (QI) development, providing treatment challenges resulting in variable or substandard care. The American Academy of Otolaryngology-Head and Neck Surgery recently updated their SSNHL guidelines. With SSNHL demonstrating a large burden of illness, this study sought to leverage the updated guidelines and develop QIs that support quality improvement initiatives at an individual, institutional, and systems level. Candidate indicators (CIs) were extracted from high-quality SSNHL guidelines that were evaluated using the Appraisal of Guidelines for Research and Evaluation II tool. Each CI and its supporting evidence were summarized and reviewed by a nine-member expert panel based on validity, reliability, and feasibility of measurement. Final QIs were selected from CIs using the modified RAND Corporation-University of California, Los Angeles appropriateness methodology. Fifteen CIs were identified after literature review. After the first round of evaluations, the panel agreed on 11 candidate indicators as appropriate QIs with 2 additional CIs suggested for consideration. An expert panel meeting provided a platform to discuss areas of disagreement before final evaluations. The expert panel subsequently agreed upon 11 final QIs as appropriate measures of high-quality care for SSNHL. The 11 proposed QIs from this study are supported by evidence and expert consensus, facilitating measurement across a wide breadth of quality domains. With the recently updated SSNHL guidelines, and a greater focus on quality improvement opportunities, these QIs may be used by healthcare providers for targeted quality improvement initiatives.

A demonstration of using formal consensus methods within guideline development; a case study

BackgroundRecommendations within guidelines are developed by synthesising the best available evidence; when limited evidence is identified recommendations are generally based on informal consensus. However, there are potential biases in group decision making, and formal consensus methods may help reduce these.MethodsWe conducted a case study using formal consensus, to develop one set of recommendations within the Neonatal Parenteral Nutrition guideline being produced for the National Institute for Health and Care Excellence. Statements were generated through identification of published guidelines on several topics relating to neonatal parenteral nutrition. Ten high quality guidelines were included, and 28 statements were generated; these statements were rated by the committee via two rounds of voting. The statements which resulted in agreement were then used to develop the recommendations.ResultsThe approach was systematic and provided transparency. Additionally, a number of lessons were learnt; including the value of selecting the appropriate topic, giving adequate time to the process, and ensuring methodologies are understood by the committee for their value and relevance.ConclusionFormal consensus is a valuable option for use within guideline development when specific criteria are met. The approach provides transparent methodology, ensuring clarity on how recommendations are developed.

Quality assessment of clinical guidelines on probiotics therapy in children with IBD using the AGREE II instrument.

The morbidity of inflammatory bowel disease (IBD) in children has significantly increased in recent years. The diagnosis and treatment of IBD in children are progressing rapidly. Probiotics have been extensively studied in a variety of gastrointestinal diseases. However, the effectiveness of probiotics for IBD is inconsistent. This study summarized the recommendations on using probiotics from high-quality guidelines, and the recommendations may assist clinicians in the treatment of paediatric IBD. Guidelines were identified by searching PubMed, EMBASE, three Chinese literature databases and websites of relevant institutions. Guidelines that addressed the treatments of paediatric IBD in Chinese and English were included and evaluated with the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument to assess methodological quality. The levels of recommendation were also evaluated, and finally, the recommendations of probiotics application in IBD were summarized. A total of 14 guidelines that met inclusion criteria were identified and evaluated, and 12 of them were evidence-based (EB) guidelines, and the other two guidelines were developed by consensus. The mean percentages for the AGREE II domain scores were as follows: "Scope and purpose" 97.22%, "Clarity of presentation" 93.78%, "Applicability" 55.85%, "Editorial independence" 59.92%, "Stakeholder involvement" 74.34%, and "Rigor of development" 71.58%. Three guidelines received the Grade A-"Strongly recommended," the rest of the guidelines received a B grade-"Recommended with modifications" in the overall assessment. The overall quality of the guidelines on IBD management in children was high. Conversely, the fundamental recommendations on the application of probiotics in the treatment of IBD varied. For instance, the recommendations of probiotics on Crohn's disease (CD) were not available by any of the analysed guidelines, the recommendations of utilizing probiotics in treating ulcerative colitis (UC) were not uniform as several guidelines considered using VSL#3 or Escherichia coli Nissle 1917 for the treatment.

Outcome measures to assess the effectiveness of endodontic treatment for pulpitis and apical periodontitis for use in the development of European Society of Endodontology (ESE) S3 level clinical practice guidelines: a protocol.

The European Society of Endodontology (ESE) is in the process of developing S3Level Clinical Practice Guidelines for the treatment of pulpal and apical disease for the benefit of clinicians and patients. In order to ensure a homogenous review process in the development of the clinical practice guidelines, it is essential that the core outcomes for all endodontic treatments are standardized and recommendations are made regarding minimum follow-up time specific to each outcome measure. In the absence of a recognized core outcome set in Endodontics, the current project aimed to follow an established consensus process to define the most appropriate clinician and patient-reported outcomes. As part of the project, recommendations will also be agreed regarding an acceptable minimum follow-up period for studies by literature review and group discussion. The selected outcome measures and follow-up periods will be used in subsequent systematic analyses of the literature to investigate the effectiveness of endodontic treatment to alleviate pulpitis and apical periodontitis. In this paper, previous reviews, ESE Guidelines and Position Statements were searched in order to compile a list of potentially important outcome measures for the treatment of pulpitis (working group 1), the nonsurgical treatment of apical periodontitis (working group 2), the surgical treatment of apical periodontitis (working group 3) and the regenerative treatment of apical periodontitis (working group 4). Initially, the two S3 guideline leads selected two independent senior clinical academics with experience of evidence-based dentistry to lead each of the four working groups forming a 10-member steering group. The working group leads in turn selected 32 academics with experience of evidence-based dentistry to lead the individual systematic reviews contained within the respective working groups. These 42 individuals make up the Guideline Development Group (GDG). Prior to the selected systematic reviewers commencing writing and submitting the review protocol, the complete list of outcome variables identified in this document will be ranked by the 42 members of the GDG in their importance to the individual patient using a 9-point Likert scale. A summary of the survey scores will thereafter be shared with the members of the group and the final list of clinician and patient-reported outcome measures rated as critical for decision making (7-9 on Likert scale by majority of survey participants) to guide systematic reviews will be consented and confirmed during an online meeting of the steering group. In this online meeting, another aspect with regard to meaningfulness of clinical trial results to be addressed in systematic reviews will be consented: length of follow-up. In order to develop high quality guidelines, it is suggested that the follow-up period after treatment should be related to the specific outcome measure being addressed; however, a minimum of one year for assessing the effectiveness of treatments for pulpitis and apical periodontitis should be considered. It is accepted, that selected research questions that focus on pain, swelling, medication taken or investigating diagnostic accuracy are likely to have shorter follow-up periods. As a result of the GDG consensus process, the outcome measures and length of follow-up will, alongside the use of standard instruments to assess the methodological quality of clinical trials and other comparative studies, be applied to all the commissioned systematic reviews that will inform the subsequent process when developing the ESE S3 Level Clinical Practice Guidelines.

Osteoporosis guidelines from a rehabilitation perspective: systematic analysis and quality appraisal using AGREE II.

People affected by osteoporosis and fragility fractures often report disability and poor health-related quality of life. Albeit rehabilitation has a crucial role in older people, post-menopausal women and other subjects with high risk of fragility fractures, the rehabilitation perspective has been poorly investigated in the available guidelines for osteoporosis. The aim of this systematic review was to systematically evaluate the quality of guidelines for osteoporosis from a rehabilitation perspective. On May 2020, we performed a systematic search on medical literature of all guidelines published in the last 10 years on PubMed, Pedro, and international guideline databases. The study selection was based on key terms "exercise," "physical activity" or "rehabilitation." All authors independently assessed the methodological quality through the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument, consisting of six domains (scope, stakeholder involvement, rigor and development, clarity of presentation, applicability, editorial independence). Out of 331 documents retrieved, a total of 34 guidelines were selected after the screening phases. Twenty (58.8%) high quality guidelines were reported. According to AGREE II instrument, a mean score of 78.1±21.8% was reported for "scope and purpose" domain; for stakeholder involvement, the mean score was 58.1±22.1%; the rigor of development was good (mean score of 61.3±27.3%); for clarity of presentation the mean score was 79.4±20.3%; the applicability was poor (mean score of 30.9±25.2%); for editorial independence the mean score was 75.1±24.6%. Rehabilitation recommendations for osteoporotic patients were reported in 21 (61.8%) of the selected guidelines. This is the first systematic analysis evaluating quality of the guidelines for osteoporosis using AGREE II instrument. Starting from a state of the art of the currently available evidence, we could conclude that therapeutic exercise at moderate to high intensity is encouraged by several guidelines for the management of people with osteoporosis and fragility fractures. More than half of guidelines were of high-quality. However, most guidelines are lacking specific indications about exercise features. This study might support the implementation of a rehabilitation perspective in the guidelines for osteoporotic patients.