Grading Recommendations Assessment, Development And Evaluation Research Articles

The effect of dietary interventions on inflammatory biomarkers among people with multiple sclerosis: A protocol for systematic review and meta-analysis of randomized controlled trials.

Multiple sclerosis (MS) is a chronic neuroinflammatory disease of the central nervous system, characterized by demyelination and neurodegeneration, which has a profound impact on the quality of life. Dysregulated inflammatory processes are a major driver of MS progression, with many areas of research being dedicated to modulating inflammation in people with MS. Several dietary patterns have been associated with improvements in inflammatory biomarkers; although, the findings have been inconsistent. Thus, this study aims to evaluate the effects of dietary interventions on inflammatory markers in adults with MS. Electronic databases, including PubMed/MEDLINE, Web of Science, Scopus, and Cochrane/Central, will be searched. Screening, selection, and extraction of data, along with quality assessment of included studies, will be done by two separate reviewers, and any potential conflicts will be settled through discussion. Two reviewers will independently assess the risk of bias in included studies using the Cochrane Risk of Bias Tool. If plausible, the results will be synthesized and pooled for meta-analysis. The overall quality of evidence of each study will be evaluated using the NutriGRADE tool, which is a modification to the Grading Recommendations Assessment, Development, and Evaluation (GRADE) developed specifically for nutrition research. Studies have demonstrated conflicting results regarding the effects of dietary interventions on serum levels of inflammatory biomarkers among people with MS. Thus, it is expected that the planned systematic review and meta-analysis will yield robust evidence on the effects of diet on inflammatory profile in the setting of MS.

Executive Summary: Guidelines for the Management of Adult Acute and Acute-on-Chronic Liver Failure in the ICU: Neurology, Peri-Transplant Medicine, Infectious Disease, and Gastroenterology Considerations.

Executive Summary: Guidelines for the Management of Adult Acute and Acute-on-Chronic Liver Failure in the ICU: Neurology, Peri-Transplant Medicine, Infectious Disease, and Gastroenterology Considerations.

Dexmedetomidine for the prevention of delirium in adults admitted to the intensive care unit or post-operative care unit: A systematic review of randomised clinical trials with meta-analysis and Trial Sequential Analysis.

To assess any benefit or harm, we conducted a systematic review of randomised clinical trials (RCTs) allocating adults to dexmedetomidine versus placebo/no intervention for the prevention of delirium in intensive care or post-operative care units. We searched Medline, Embase, CENTRAL and other databases. The last search was 9 April 2022. Literature screening, data extraction and risk of bias volume 2 assessments were performed independently and in duplicate. Primary outcomes were occurrences of serious adverse events (SAEs), delirium and all-cause mortality. We used meta-analysis, Trial Sequential Analysis, and GRADE (Grading Recommendations Assessment, Development and Evaluation). Eighty-one RCTs (15,745 patients) provided data for our primary outcomes. Results from trials at low risk of bias showed that dexmedetomidine may reduce the occurrence of the most frequently reported SAEs (relative risk [RR] 0.69; 95% CI 0.43-1.09), cumulated SAEs (RR 0.70; 95% CI 0.52-0.95) and the occurrence of delirium (RR 0.62; 95% CI 0.43-0.89). The certainty of evidence was very low for delirium. Mortality was very low in trials at low risk of bias (0.4% in the dexmedetomidine groups and 1.0% in the control groups) and meta-analysis did not provide conclusive evidence that dexmedetomidine may result in lower or higher all-cause mortality (RR 0.47; 95% CI 0.18-1.21). There was a lack of information from trial results at low risk of bias for all primary outcomes. Trial results at low risk of bias showed that dexmedetomidine might reduce occurrences of SAEs and delirium, while no conclusive evidence was found for effects on all-cause mortality. The certainty of evidence ranged from very low for occurrence of delirium to low for the remaining outcomes.

Efficacy and safety of Puerarin injection on acute heart failure: A systematic review and meta-analysis

ObjectiveThis study aimed to assess the adjunctive efficacy and safety of Puerarin injection (PI) on acute heart failure (AHF) based on a systematic review and meta-analysis.MethodsNine databases were searched from March 1990 to March 2022 to identify randomized controlled trials (RCTs) related to the adjunctive treatment of PI for AHF. The Cochrane collaboration tool was used to assess the risk of bias in the included studies. Meta-analysis and subgroup and sensitivity analyses were conducted by RevMan 5.3 software. The evidence’s certainty was evaluated by grading recommendations assessment, development, and evaluation (GRADE) methods.ResultsA total of 8 studies were included with a total of 614 patients with AHF. The meta-analysis demonstrated that adjunctive treatment with PI on AHF was superior to conventional medicine alone. It increased the total effective rate (RR = 1.38; 95% CI, 1.22–1.55; p < 0.001) and improved left ventricular ejection fraction [SMD = 0.85; 95% CI (0.62, 1.09); p < 0.001]. Regarding safety, a total of 11.9% (23/194) adverse reactions were observed in the PI group and 9.8% (19/194) adverse reactions in the control group, and there were no significant differences in the incident rate of adverse events between both groups [RR = 1.16; 95% CI (0.66–2.05); p = 0.061]. The outcomes’ evidentiary quality was assessed as “moderate.”ConclusionPI had an adjunctive effect on AHF combined with conventional medicine, and it seemed to be safe and more effective than the conventional medical treatment alone for improving the total clinical effective rate and left ventricular ejection fraction. But further well-designed RCTs are required to confirm the efficacy and safety of XBP in treating AHF due to the poor methodological quality of the included RCTs.Systematic Review Registration:[https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=327636], identifier [CRD42022327636].

A Systematic Review and Meta-Analysis of the Efficacy and Safety of Xinbao Pill in Chronic Heart Failure.

Objective: This study aimed to clarify the efficacy and safety of Xinbao pill (XBP) as an adjunctive treatment for chronic heart failure (CHF). Methods: Randomized controlled trials (RCTs) on the efficacy and safety of XBP in the treatment of CHF were searched from the six databases. The risk of bias assessment tool recommended by Cochrane Handbook 5.1 were used to assess the methodological quality of the included studies. RevMan 5.3 software was used for meta-analysis. The subgroup and sensitivity analyses were also performed. The grading recommendations assessment, development, and evaluation (GRADE) technique were used to assess the evidence’s certainty. Results: Nine RCTs with a total of 882 patients were identified in this study. The meta-analysis demonstrated that XBP as adjunctive therapy was superior to conventional medicine alone for the treatment of CHF in improving the left ventricular ejection fraction (LVEF; MD = 5.34; 95% CI 4.68 to 5.99; p < 0.001), the total effective rate (RR = 1.21; 95% CI, 1.14 to 1.29; p < 0.001), the cardiac output (MD = 0.56; 95% CI 0.42 to 0.70; p < 0.001), the stroke volume (MD = 3.42; 95% CI 2.03 to 4.81; p < 0.001) and the 6-min walking distance (6-MWD; MD = 31.95; 95% CI 21.83 to 42.06; p < 0.001), meanwhile reducing the left ventricular end-diastolic diameter (LVEDD; MD = −3.22; 95% CI −4.03 to −2.42; p < 0.001) and left ventricular end-systolic dimension (LVESD; MD = −2.93; 95% CI −3.80 to −2.06; p < 0.001). Regarding safety, a total of 2.4% (11/456) adverse reactions occurred in the XBP groups while 3.9% (18/456) in the control group. The outcomes’ evidentiary quality ranged from “very low” to “moderate”. Conclusion: This study indicated that XBP as adjunctive therapy combined with conventional medicine seemed to be safe and more effective than conventional medicine alone in treating CHF. However, due to the poor methodological quality of the included RCTs, further well-designed RCTs are required to confirm the efficacy and safety of XBP.

Quality assessment of Japanese clinical practice guidelines including recommendations for acupuncture

BackgroundThe quality of clinical practice guidelines (CPGs) should be extensively evaluated. This study aimed to evaluate Japanese CPGs that include recommendations for acupuncture. MethodsIn a literature search, CPGs including recommendations for acupuncture published in Japan until October 2021 were sought. We assessed (1) whether the CPGs were developed in accordance with the Grading Recommendations Assessment, Development and Evaluation (GRADE) system, (2) the quality of the CPGs using the Appraisal of Guidelines for Research and Evaluation (AGREE) II, and (3) whether the strength of the recommendations for acupuncture was consistent with each CPG's predefined procedure. ResultsSeventeen CPGs including 23 recommendations in total were identified and assessed. (1) Three CPGs were in accordance with the GRADE system. (2) The mean score of overall assessment using AGREE II was 4.5 on a 7-point Likert scale. The mean domain scores were 77% for domain 1 (scope and purpose), 54% for domain 2 (stakeholder involvement), 48% for domain 3 (rigor of development), 78% for domain 4 (clarity of presentation), 20% for domain 5 (applicability), and 51% for domain 6 (editorial independence). (3) The strength of the recommendations for acupuncture in two CPGs was judged to be underestimated. Some of the CPGs contained elementary problems that were not considered in AGREE II. ConclusionThe methodological quality of Japanese CPGs including recommendations for acupuncture was not necessarily high. Since technical issues exist in each field of therapy, the respective experts should be involved in developing and reviewing CPGs to disseminate accurate health information.

Chinese consensus on Denonvilliers' fascia preserving total mesorectal excision (iTME) (2021 version)

In 1982, total mesorectal excision(TME) was proposed by Professor R. J. Heald, which was a milestone-style for rectal cancer surgery. The concept of TME has reduced the local recurrence rate of mid-low rectal cancer (MLRC) significantly, thus becomes the gold standard for MLRC surgery. However, the incidence of urogenital dysfunction after TME remains high, among which urinary dysfunction reaches 30%-60%, and sexual dysfunction reaches 50%-70%. In recent years, studies have shown that the removal of Denonvilliers' fascia (DVF) during TME is an important cause of postoperative urination and sexual dysfunction. Therefore, DVF preserving total mesorectal excision (iTME) has been recognized by more and more surgical experts. On the basis of existing literature and clinical practice, we organize experts to discuss and vote, put forward recommendations for several issues of iTME, and finally formulate this expert consensus. The formulation of this consensus aims to increase surgeons' awareness of the value and functional protection of DVF during TME surgery, clarify the indications and contraindications of iTME, and standardize the procedure of iTME, so as to reduce postoperative urination and sexual dysfunction and improve the quality of life of patients with MLRC. The level of evidence and recommendation of this consensus is determined by Grading Recommendations, Assessment, Development and Evaluation (GRADE), and the consensus content is determined through expert voting and Delphi method.

Guidelines for the Management of Adult Acute and Acute-on-Chronic Liver Failure in the ICU: Cardiovascular, Endocrine, Hematologic, Pulmonary and Renal Considerations: Executive Summary.

OBJECTIVES To develop evidence-based recommendations for clinicians caring for adults with acute or acute on chronic liver failure in the ICU. DESIGN The guideline panel comprised 29 members with expertise in aspects of care of the critically ill patient with liver failure and/or methodology. The Society of Critical Care Medicine standard operating procedures manual and conflict-of-interest policy were followed throughout. Teleconferences and electronic-based discussion among the panel, as well as within subgroups, served as an integral part of the guideline development. SETTING The panel was divided into nine subgroups: cardiovascular, hematology, pulmonary, renal, endocrine and nutrition, gastrointestinal, infection, perioperative, and neurology. INTERVENTIONS We developed and selected population, intervention, comparison, and outcomes questions according to importance to patients and practicing clinicians. For each population, intervention, comparison, and outcomes question, we conducted a systematic review aiming to identify the best available evidence, statistically summarized the evidence whenever applicable, and assessed the quality of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach. We used the evidence to decision framework to facilitate recommendations formulation as strong or conditional. We followed strict criteria to formulate best practice statements. MEASUREMENTS AND MAIN RESULTS In this article, we report 29 recommendations (from 30 population, intervention, comparison, and outcomes questions) on the management acute or acute on chronic liver failure in the ICU, related to five groups (cardiovascular, hematology, pulmonary, renal, and endocrine). Overall, six were strong recommendations, 19 were conditional recommendations, four were best-practice statements, and in two instances, the panel did not issue a recommendation due to insufficient evidence. CONCLUSIONS Multidisciplinary international experts were able to formulate evidence-based recommendations for the management acute or acute on chronic liver failure in the ICU, acknowledging that most recommendations were based on low-quality indirect evidence.

Clinical Practice Guidelines for Pancreatic Cancer 2019 From the Japan Pancreas Society: A Synopsis.

ObjectivesClinical Practice Guidelines for Pancreatic Cancer were first published in 2006 by the Japan Pancreas Society, and they were revised in 2009, 2013, and 2016. In July 2019, the Clinical Practice Guidelines for Pancreatic Cancer 2019 were newly revised in Japanese.MethodsFor this version, we developed the new guidelines according to the Minds Manual for Guideline Development 2017, which includes the concepts of GRADE (Grading Recommendations Assessment, Development, and Evaluation), to enable a better understanding of the current guidelines.ResultsThe guidelines show algorithms for the diagnosis, treatment, and chemotherapy of pancreatic cancer and address 7 subjects: diagnosis, surgical therapy, adjuvant therapy, radiation therapy, chemotherapy, stent therapy, and supportive and palliative medicine. They include 56 clinical questions and 84 statements. There are statements corresponding to clinical questions, evidence levels, recommendation strengths, and agreement rates.ConclusionsThese guidelines represent the most standard clinical and practical management guidelines at this time in Japan. This is the English synopsis of the Clinical Practice Guidelines for Pancreatic Cancer 2019 in Japanese and is an attempt to disseminate the Japanese guidelines worldwide for introducing the Japanese approach for clinical management of pancreatic cancer.

The saudi critical care society clinical practice guidelines on the management of COVID-19 patients in the intensive care unit

Background: Although recent international guidelines have been published on the management of critically ill patients with the novel coronavirus disease 2019 (COVID-19), there is a vital need to develop clinical practice guidelines tailored to the context of Saudi Arabia. Methods: The Saudi Critical Care Society (SCCS) is the sponsor for this guideline. The expert panel consisted of 19 members. All members completed the World Health Organization Conflict of Interest Form. The expert panel formulated questions on the management of critically ill patients in the intensive care unit with COVID-19. Panel members identified relevant studies. The panel used the categories of Grading Recommendations, Assessment, Development, and Evaluation (GRADE) to assess the confidence in the evidence. Results: The SCCS expert panel issued 53 statements; of which 7 were strong recommendations, 9 were best practice statements, 32 were weak recommendations, and we were not able to issue recommendations in 5 instances. The statements covered different aspects of the critical illness in COVID-19 patients, including: infection control; therapeutic interventions; supportive care; and crisis management. Conclusion: The SCCS guidelines on the management of critically ill COVID-19 patients have been based on the best available evidence and tailored to the context of Saudi Arabia. These guidelines will be updated periodically to incorporate new evidence.

Masticatory Dysfunction by Extensive Tooth Loss as a Risk Factor for Cognitive Deficit: A Systematic Review and Meta-Analysis

Background: An amount of cognition decline is normal with aging; however, intrinsic and extrinsic risk factors may exacerbate it, affecting social and occupational tasks. Masticatory dysfunction (MD), as a general term, refers to an impairment in the masticatory function triggered by a structural factor, such as tooth loss; functional factors, such as weaker bite force or a poorer masticatory performance; or both factors. MD acting as a source of chronic stress, promotes functional and morphological changes on the hippocampus, a brain area crucial for learning and memory abilities. This study aimed to synthesize evidence on the association between MD and cognitive deficit (CD), and demonstrate whether might be adequately considered as a risk factor.Methods: Observational studies were screened in seven online databases; the search strategy (PECO) was focused in observational studies with humans as a population (P), presenting groups exposed (E), and non-exposed (C) to tooth loss, in which cognition parameters were measured and compared between groups (O). The final selection included only those studies comparing the effect in cognition between subjects having ≥20 remaining teeth and <20 remaining teeth, considering the latter as a structural factor triggering MD by the literature. Searching and data extraction were conducted following PRISMA guidelines. Qualitative and risk of bias evaluations were performed. The meta-analysis (MA) was constructed including the odds ratio (OR) and its 95% confidence interval (CI) comparing two groups—with/without MD. The level of evidence was rated by Grading Recommendations Assessment, Development and Evaluation (GRADE) approach.Results: In total, 5,666 citations were identified, 14 accomplished our eligibility criteria, and nine were include in the MA. The MA demonstrates that individuals with MD had 46% higher chance to presented CD (OR 2.24 [1.73, 2.90], p < 0.00001, I2 = 46%). The level of evidence was rated as low by GRADE.Conclusion: Despite the low certainty in evidence, according to our MA, MD is positively associated with increased risk of CD. However, more studies including other factors underlying MD and similar measurements should be conducted to obtain a strong estimate of the risk.

Methods for\xa0trustworthy nutritional recommendations NutriRECS (Nutritional Recommendations and accessible Evidence summaries Composed of Systematic reviews): a protocol

BackgroundRecent systematic reviews and editorials suggest that many organizations that produce nutritional guideline recommendations do not adhere to internationally recognized standards set forth by the Institute of Medicine (IoM), Guidelines International Network (GIN), Appraisal of Guidelines Research and Evaluation (AGREE), and Grading Recommendations, Assessment, Development and Evaluation (GRADE).MethodsThe potential solution is an independent group with content expertise and skilled in the methodology of systematic reviews and practice guidelines to produce trustworthy guideline recommendations, recommendations that are supported by publication in a top tier journal. The BMJ Rapid Recommendations project has recently demonstrated the feasibility and utility of this approach. Here, we are proposing trustworthy nutritional guideline recommendations based on internationally accepted guideline development standards, recommendations that will be informed by rigorous and novel systematic reviews of the benefits and harms associated with nutritional exposures, as well as studies on the values and preferences related to dietary behaviors among members of the international community.DiscussionAdhering to international guideline standards, conducting high quality systematic reviews, and actively assessing the values and preferences of key stakeholders is expected to improve the quality of nutritional guidelines and their relevance to end-users, particularly patients and community members. We will send our work for peer review, and if found acceptable, we will publish our nutritional recommendations in top-tier general medicine journals.

From MARS to MAGIC: The remarkable journey through time and space of the Grading of Recommendations Assessment, Development and Evaluation initiative.

For over 30years, "evidence-based" clinical guidelines remained entrenched in an oversimplified, design-based, framework for rating the strength of evidence supporting clinical recommendations. The approach frequently equated the rating of evidence with that of the recommendations themselves. "Grading Recommendations Assessment, Development and Evaluation (GRADE)" has emerged as a proposed antidote to obsolete guideline methodology. GRADE sponsors and collaborators are in the process of attempting to amplify and extend the framework to encompass implementation and adaptation of guidelines, above and beyond the evaluation and rating of clinical research. Alternative schemes and models for such extensions are beginning to appear. This commentary reviews the strengths and weaknesses of GRADE with reference to other recent critiques. It considers the GRADE Working Group's "evidence-to-decision" extension of the evidence rating framework, together with proposed alternatives. It identifies pitfalls of the GRADE system's cooptation of relational processes necessary to the interpretation and uptake of recommendations that properly belong to end-users. It also identifies dangers inherent in blurring important boundaries between clinical and policy applications of guidelines. Finally, it addresses criticisms regarding the lack of a theoretical framework supporting the different facets of the GRADE approach and proposes a social constructivist orientation to clinical guideline development and use. Recommendations are offered to potential guideline developers and users regarding how to draw upon the strengths of the GRADE framework without succumbing to its pitfalls.

Where is students\u2019 research in evidence-informed decision-making in health? Assessing productivity and use of postgraduate students\u2019 research in low- and middle-income countries: a systematic review

BackgroundInvesting in research that is not accessible or used is a waste of resources and an injustice to human subject participants. Post-graduate students’ research in institutions of higher learning involves considerable time, effort and money, warranting evaluation of the return on investment. Although individual studies addressing research productivity of post-graduate students are available, a synthesis of these results in low-income settings has not been undertaken. Our first aim is to identify the types of approaches that increase productivity and those that increase the application of medical post-graduate students’ research and to assess their effectiveness. Our second aim is to assess the determinants of post-graduate students’ research productivity.MethodsWe propose a two-stage systematic review. We will electronically search for published and grey literature in PubMed/MEDLINE and the ERIC databases, as well as contact authors, research administration units of universities, and other key informants as appropriate. In stage one, we will map the nature of the evidence available using a knowledge translation framework adapted from existing literature. We will perform duplicate screening and selection of articles, data abstraction, and risk of bias assessments for included primary studies as described in the Cochrane handbook for systematic reviews. Our primary outcome is publication output as a measure of research productivity, whilst we defined research use as citations in peer-reviewed journals or policy-related documents as our secondary outcome. In stage two, we will perform a structured narrative synthesis of the findings and advance to quantitative meta-analysis if the number of studies are adequate and their heterogeneity is low. Adapting the Grading, Recommendations, Assessment, Development and Evaluation (GRADE) approach, we will assess the overall quality of evidence for effects, and report our results in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.DiscussionWe will share our findings with universities, other training institutions, civil society, funders as well as government departments in charge of education and health particularly in low- and middle-income countries.

Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children.

Individuals infected with Mycobacterium tuberculosis (Mtb) may develop symptoms and signs of disease (tuberculosis disease) or may have no clinical evidence of disease (latent tuberculosis infection [LTBI]). Tuberculosis disease is a leading cause of infectious disease morbidity and mortality worldwide, yet many questions related to its diagnosis remain. A task force supported by the American Thoracic Society, Centers for Disease Control and Prevention, and Infectious Diseases Society of America searched, selected, and synthesized relevant evidence. The evidence was then used as the basis for recommendations about the diagnosis of tuberculosis disease and LTBI in adults and children. The recommendations were formulated, written, and graded using the Grading, Recommendations, Assessment, Development and Evaluation (GRADE) approach. Twenty-three evidence-based recommendations about diagnostic testing for latent tuberculosis infection, pulmonary tuberculosis, and extrapulmonary tuberculosis are provided. Six of the recommendations are strong, whereas the remaining 17 are conditional. These guidelines are not intended to impose a standard of care. They provide the basis for rational decisions in the diagnosis of tuberculosis in the context of the existing evidence. No guidelines can take into account all of the often compelling unique individual clinical circumstances.

Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children.

Individuals infected with Mycobacterium tuberculosis (Mtb) may develop symptoms and signs of disease (tuberculosis disease) or may have no clinical evidence of disease (latent tuberculosis infection [LTBI]). Tuberculosis disease is a leading cause of infectious disease morbidity and mortality worldwide, yet many questions related to its diagnosis remain. A task force supported by the American Thoracic Society, Centers for Disease Control and Prevention, and Infectious Diseases Society of America searched, selected, and synthesized relevant evidence. The evidence was then used as the basis for recommendations about the diagnosis of tuberculosis disease and LTBI in adults and children. The recommendations were formulated, written, and graded using the Grading, Recommendations, Assessment, Development and Evaluation (GRADE) approach. Twenty-three evidence-based recommendations about diagnostic testing for latent tuberculosis infection, pulmonary tuberculosis, and extrapulmonary tuberculosis are provided. Six of the recommendations are strong, whereas the remaining 17 are conditional. These guidelines are not intended to impose a standard of care. They provide the basis for rational decisions in the diagnosis of tuberculosis in the context of the existing evidence. No guidelines can take into account all of the often compelling unique individual clinical circumstances.

Impact of Prehospital Care on Outcomes in Sepsis: A Systematic Review.

IntroductionSepsis is a common and potentially life-threatening response to an infection. International treatment guidelines for sepsis advocate that treatment be initiated at the earliest possible opportunity. It is not yet clear if very early intervention by ambulance clinicians prior to arrival at hospital leads to improved clinical outcomes among sepsis patients.MethodaWe systematically searched the electronic databases MEDLINE, EMBASE, CINAHL, the Cochrane Library and PubMed up to June 2015. In addition, subject experts were contacted. We adopted the GRADE (grading recommendations assessment, development and evaluation) methodology to conduct the review and follow PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) recommendations to report findings.ResultsNine studies met the eligibility criteria – one study was a randomized controlled trial while the remaining studies were observational in nature. There was considerable variation in the methodological approaches adopted and outcome measures reported across the studies. Because of these differences, the studies did not answer a unique research question and meta-analysis was not appropriate. A narrative approach to data synthesis was adopted.ConclusionThere is little robust evidence addressing the impact of prehospital interventions on outcomes in sepsis. That which is available is of low quality and indicates that prehospital interventions have limited impact on outcomes in sepsis beyond improving process outcomes and expediting the patient’s passage through the emergency care pathway. Evidence indicating that prehospital antibiotic therapy and fluid resuscitation improve patient outcomes is currently lacking.

The effectiveness of melatonin for promoting healthy sleep: a rapid evidence assessment of the literature.

A systematic review was conducted using Samueli Institute’s Rapid Evidence Assessment of the Literature (REAL©) process to determine the evidence base for melatonin as an agent to optimize sleep or improve sleep quality, and generalize the results to a military, civilian, or other healthy, active, adult population. Multiple databases were searched yielding 35 randomized controlled trials (RCTs) meeting the review’s inclusion criteria, which were assessed for methodological quality as well as for melatonin effectiveness. The majority of included studies were high quality (83.0%). Overall, according to Grading Recommendations, Assessment Development and Evaluation (GRADE) methodology, weak recommendations were made for preventing phase shifts from jet lag, for improving insomnia in both healthy volunteers and individuals with a history of insomnia, and for initiating sleep and/or improving sleep efficacy. Based on the literature to date, no recommendations for use in shift workers or to improve hormonal phase shift changes in healthy people can be made at this time. Larger and longer-duration RCTs utilizing well characterized products are needed to warrant melatonin recommendations in young, healthy adults.

Cervix Cancer Screening Guideline Judgments Are Not Explicit and Transparent

To the Editor The new screening guidelines for the “prevention and early detection of cervical cancer” were jointly published by the American Cancer Society, American Society for Colposcopy and Cervical Pathology (ASCCP), and American Society for Clinical Pathology (ASCP) in the American Journal of Clinical Pathology , CA: A Cancer Journal for Clinicians , and the Journal of Lower Genital Tract Disease on March 14, 2012.1 I am asking for more transparency and more explicit disclosure of the judgments about risk and harm thresholds and trade-offs. The guideline panels used the GRADE (Grading Recommendations Assessment, Development, and Evaluation) system to provide a framework for the guideline development process. An integral aspect of the GRADE process is that the grading of the recommendations must be explicit, and that the judgments made by the panels to determine the balance between benefits and risks be explicit and not hidden. I appreciate that there are supplemental materials, including the work of the subgroups that you have made available online.2 I also appreciate that most professionals will not have time to read the entire guideline article, much less the supplemental materials, and that patients and stakeholders will likely not access these materials. The guideline publication explains the difference between strong and weak recommendations, acknowledges that both types were included in the document, but does not stipulate which recommendations were strong and which were …

Cervix Cancer Screening Guideline Judgments Are Not Explicit and Transparent

To the Editor The new screening guidelines for the “prevention and early detection of cervical cancer” were jointly published by the American Cancer Society, American Society for Colposcopy and Cervical Pathology (ASCCP), and American Society for Clinical Pathology (ASCP) in the American Journal of Clinical Pathology , CA: A Cancer Journal for Clinicians , and the Journal of Lower Genital Tract Disease on March 14, 2012.1 I am asking for more transparency and more explicit disclosure of the judgments about risk and harm thresholds and trade-offs. The guideline panels used the GRADE (Grading Recommendations Assessment, Development, and Evaluation) system to provide a framework for the guideline development process. An integral aspect of the GRADE process is that the grading of the recommendations must be explicit, and that the judgments made by the panels to determine the balance between benefits and risks be explicit and not hidden. I appreciate that there are supplemental materials, including the work of the subgroups that you have made available online.2 I also appreciate that most professionals will not have time to read the entire guideline article, much less the supplemental materials, and that patients and stakeholders will likely not access these materials. The guideline publication explains the difference between strong and weak recommendations, acknowledges that both types were included in the document, but does not stipulate which recommendations were strong and which were …