PMC:7003341 / 2592-12249 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/7003341","sourcedb":"PMC","sourceid":"7003341","source_url":"https://www.ncbi.nlm.nih.gov/pmc/7003341","text":"2 Guideline methodology\nThis guideline was prepared in accordance with the methodology and general rules of WHO Guideline Development and the WHO Rapid Advice Guidelines [1, 2].\n\n2.1 Composition of the guideline development group\nThis guideline development group is multidisciplinary and composed of individuals from health professionals and methodologists. Health professionals included frontline clinical doctors, nurses who work in departments of respiratory medicine, fever clinic, critical medicine, emergency, infectious disease, and experts of respiratory infectious disease and hospital management board. The methodologists included methodologists of guideline development, systematic review, and literature searching professionals.\n\n2.2 The end-user of the guideline\nThis guideline is suitable for frontline doctors and nurses, managers of hospitals and healthcare sections, healthy community residents, personnel in public healthcare, relevant researchers, and all persons who are interested in the 2019-nCoV management.\n\n2.3 The target population of the guideline\nThis guideline is aimed to serve the healthcare professionals to tackle the suspected 2019-nCoV infected cases, confirmed 2019-nCoV infected cases, clustered 2019-nCoV infected cases, and those with close contacts or suspicious exposure to 2019-nCoV infected cases.\n\n2.4 A survey of conflict of interests\nOral inquiry for financial interests of relevant personal was conducted at the first meeting while to start this guideline. Relevant financial as well as nonfinancial interests were surveyed and disclosed and subsequently assessed in consensus conference in order to minimize potential bias in guideline development. Finally, there is no conflict of interests for all the personnel participating to prepare this guideline.\n\n2.5 Guideline’s structural setup and refining the topics and coverage of this guideline\nThis guideline is a rapid guideline to responding to the emerging infectious disease of 2019-nCoV. Due to the urgent need and tight work schedule, we conducted no wide-range survey but a discussion meeting with front-line clinicians who managed patients with 2019-nCoV infections to finalize guideline topics and key questions.\n\n2.6 Literature searching and preparation of evidence profiles\n\n2.6.1 General notes\nConsidering the lack of direct evidence for this newly identified 2019-nCoV infection, we searched and referred to the guidelines that related to the SARS (Severe Acute Respiratory Syndrome), MERS (Middle East Respiratory Syndrome), and influenza. We also referred to the guidelines which were newly-issued by the National Health Commission of People’s Republic of China and WHO for 2019-nCoV. In addition, we have an independent literature searching team to search available indirect evidence from systematic reviews and/or RCTs (randomized controlled trials), which were for the treatment and/ or chemoprophylaxis of SARS, MERS, or other influenza virus infections.\nIf the existing evidence addressed topics or questions covered by the guideline, then its quality should be assessed. If there is a lack of higher-level quality evidence, our panel considered observational studies and case series. Because of the limited time, we did not perform new systematic review. We identified relevant literature up to 20 January 2020.\n\n2.6.2 Search resources\nWe searched the bibliographic databases: PubMed, Embase, and Cochrane library.\nWe also searched following websites: the WHO (https://www.who.int/), CDC (Centers for Disease Control and Prevention, https://www.cdc.gov/), NICE (National Institute for Health and Clinical Excellence, https://www.nice.org.uk/), National Health Commission of the People’s Republic of China (http://www.nhc.gov.cn/), and National Administration of Traditional Chinese Medicine (http://www.satcm.gov.cn/).\n\n2.6.3 Frontline data collection and summary\nAs the 2019-nCoV is a newly identified pathogen responsible for the outbreak of the pandemic disease, there is no sufficient evidence to reveal the whole nature of this virus. In these situations, obtaining evidence from the experts who fighting the disease on the frontline can be efficient and the main source [3].\nUntil to 24:00 on 29 January 2020, 11,500 persons were screened, and 276 were identified as suspected infectious victims, and 170 were diagnosed (including 33 in critical condition) for 2019-nCoV infection in Zhongnan Hospital of Wuhan University. During this process, frontline clinicians and nurses have accumulated valuable experience in the diagnosis, treatment and nursing for 2019-nCoV infected patients. Hence, these experiences were assessed and then used as “Expert Evidence” for our guideline development. We took interviews and group surveys to collect information on treatment evidence during the guideline panel’s meeting, so that it could be integrated into the guideline panel in the summary of findings (see Additional files 1 and 2). Experts’ evidence can be solicited by the description of case reports, summaries, and reports of topics or questions of all cases they management.\n\n2.7 Grading the evidences and recommendations\nWe accorded to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) basic approaches and rules [4, 5], and particularly considered experts’ evidence to assess the quality of a body of evidence to make recommendations.\nThe quality of evidence reflects whether the extent to which our confidence estimating the effect is adequate to support a particular recommendation. The level of evidence was categorized as “high quality”, “moderate quality”, “low quality”, or “very low quality”; Recommendations were classified as “strong” or “weak.”\nThe strong recommendation does not always mean there is sufficient intervention effectiveness. Besides the effectiveness of intervention, the forming of recommendations is based on the severity of the disease, patient willingness, safety, and economics [4]. See Tables 1 and 2 [4, 6].\nTable 1 Classification and description of recommendation\nClassification of recommendation Description\nStrong recommendation It is definite that the desirable effects of an intervention outweigh its undesirable effects or the undesirable effects of an intervention outweigh its desirable effects\nWeak recommendation The desirable effects probably outweigh the undesirable effects or undesirable effects probably outweigh the desirable effects\nTable 2 Rules for grading the recommendations\nStrength of recommendation and quality of evidence Benefit vs. risk and burdens Methodological quality of supporting evidencea Implications\nStrong recommendation, high-quality evidence Benefits clearly outweigh risk and burdens, or vice versa RCTs without important limitations or overwhelming evidence from observational studies Strong recommendation, can apply to most patients in most circumstances without reservation\nStrong recommendation, moderate quality evidence Benefits clearly outweigh risk and burdens, or vice versa RCTs with important limitations (inconsistent results, methodological flaws, indirect or imprecise) or exceptionally strong evidence from observational studies Strong recommendation, can apply to most patients in most circumstances without reservation\nStrong recommendation, low or very low quality evidence Benefits clearly outweigh risk and burdens, or vice versa Observational studies or case series Strong recommendation but may change when higher quality evidence becomes available\nWeak recommendation, high-quality evidence Benefits closely balanced with risks and burden RCTs without important limitations or overwhelming evidence from observational studies Weak recommendation, best action may differ depending on circumstances or patients’ or societal values\nWeak recommendation, moderate quality evidence Benefits closely balanced with risks and burden RCTs with important limitations (inconsistent results, methodological flaws, indirect or imprecise) or exceptionally strong evidence from observational studies Weak recommendation, best action may differ depending on circumstances or patients’ or societal values\nWeak recommendation, low or very low quality evidence Uncertainty in the estimates of benefits, risks and burden; benefits, risk and burden may be in a closely balanced Observational studies or case series Very weak recommendations; other alternatives may be equally reasonable\nRCTs randomized controlled trials\naThe evidence agreed on by more than 70% frontline clinicians in consensus meeting is viewed as high-quality evidence\n\n2.8 Forming the recommendations\nBefore meetings, experts’ evidence was collected systematically and available to panel members. Once the evidence has been identified and assessed, recommendations were formulated based on the evidence by a face-to-face meeting of panel members and supplemented by experts participating in the panel meeting.\nExperts’ evidence was highly valued in this guideline development. During the consensus process, if the evidence was agreed on by more than 70% frontline clinicians in the consensus meeting, it is considered as high-quality evidence.\nIn specific recomendations, we used “should” or “strongly recommend” for strong recommendations; whereas, “suggest” or “consider” was used for weak ones.\n\n2.9 Drafting and publishing the guideline\nThis guideline was published in both Chinese and English versions at the same time. Due to space limitations, the current standard revision does not include evidence descriptions. The full revision will be published in New Medicine (Chinese name: Yixue Xinzhi; http://www.jnewmed.com/), Volume 30 and Issue 1 2020 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