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Standard operating procedures for ESPEN …

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EditorialStandard operating procedures for ESPEN guidelines and consensuspapersKeywords:GuidelinePositio n paperStandard operating procedureEvidence levelRecommendation gradingClinical nutritionsummaryThe ESPEN Guideline standard operating procedures (SOP) is based on the methodology provided by theAssociation of Scientific Medical Societies of Germany (AWMF), the Scottish Intercollegiate GuidelinesNetwork (SIGN), and the Centre for Evidence-based Medicine at the University of Oxford. The SOP is validand obligatory for all future ESPEN-sponsored guideline projects aiming to generate high-qualityguidelines on a regular basis. The SOP aims to facilitate the preparation of guideline projects, tostreamline the consensus process, to ensure quality and transparency, and to facilitate the disseminationand publication of ESPEN guidelines. To achieve this goal, the ESPEN Guidelines Editorial board (GEB) hasbeen established headed by two chairmen. The GEB will support and supervise the guideline processesand is responsible for the strategic planning of ESPEN guideline activities. Key elements of the SOP arethe generation of well-built clinical questions according to the PICO system, a systemic literature search,a classification of the selected literature according to the SIGN evidence levels providing an evidencetable, and a clear and straight-forward consensus procedure consisting of online voting's and a consensusconference. Only experts who meet the obligation to disclosure any potential conflict of interests andwho are not employed by the Industry can participate in the guideline process. All recommendations willbe graded according to the SIGN grading and novel outcome models besides biomedical endpoints. Thisapproach will further extent the leadership of ESPEN in creating up-to-date and suitable for imple-mentation guidelines and in sharing knowledge on malnutrition and clinical nutrition. 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights IntroductionThe European Society for Clinical Nutrition and Metabolism(ESPEN) is an international Society that fosters the developmentof guidelines in thefield of clinical nutrition. Since 1997, ESPENpublishes guidelines and position papers on a regulatory basis inClinical Nutrition, on liver and renal insufficiency or acutepancreatitis[1e4]or on screening, anthropometry and feedingtubes[5e8]. In 2005, ESPEN/ESPGHAN guidelines on pediatricparenteral nutrition were published in theJournal of PediatricGastroenterology and Nutrition[9]. In 2006, afirst comprehensivebunch of ESPEN guidelines on enteral nutrition was published inClinical Nutrition[10]. These guidelines were based to a large extenton German guidelines published before in German language. In2009, the ESPEN guidelines for adult parenteral nutritionwere pub-lished inClinical Nutrition[11]. In 2012, the guidelines for perioper-ative care were published together with the Enhanced RecoveryAfter Surgery (ERAS) Society inClinical Nutrition[12e14].In2013,the French recommendations on Nutritional therapy in major burnswere endorsed by ESPEN and published inClinical Nutrition[15].The methodology and quality of these guidelines varied of this reason, but also because the two major bundles ofESPEN guidelines, that on enteral nutrition in adults from 2006,and that of parenteral nutrition in adults from 2009 expired, ESPENlaunched a new guideline concept in 2010 proposed for four concept was focused on Medical nutrition that aims to preventand treat malnutrition in the context of diseases. This disease-spe-cific guideline framework does no more separate enteral andparenteral nutrition. Instead, a comprehensive approachcomprising screening, assessment, nutritional counseling, oralnutritional supplements, as well as enteral and parenteral nutritionis envisioned[16].This concept was launched by the authors of the invited edito-rial on ESPEN disease-specific guideline framework[16], and J. C. Preiser, who initiated four working groups ondifferent topics (cysticfibrosis, cancer, dementia, and chronic intes-tinal failure) that largely completed their work expected to be pub-lished 2015 inClinical Nutrition. The guideline process was shortlydescribed in the editorial; however, it could not been fully broughtinto practice. Thus, the process of thesefive guidelines was not fullystandardized yet. Therefore, ESPEN decided to re-launch the guide-line process with a modified methodology adapted from a GermanGuidance Manual[17]. This manual derived from the AWMF (Asso-ciation of the Scientific Medical Societies of Germany) served suc-cessfully for the German guidelines on clinical nutritionpublished since 2013 ( ). ESPEN will makeuse not only from this methodology but also from the existingGerman and other national guidelines whenever lists available atScienceDirectClinical Nutritionjournal homepage: Nutrition 34 (2015) 1043e1051 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights , such guidelines will not be endorsed by ESPEN, butupdated and modified to the European needs following a shortenedmethodology under the authorship of national and details of the new methodology that aims to create so-called S3 guidelines according to the AWMF nomenclature[17]with ahigh scientific and methodological standard will be presented inthe following standard operation procedure (SOP). TheESPENGuideline SOPwill underlie all future ESPEN guidelines and positionpapers to ensure maximal quality and coherence. This approachwill further extent the leadership of ESPEN in creating up-do-date and suitable for implementation guidelines and in sharingknowledge on malnutrition and clinical MethodologyApart from the German methodology provided by the AWMF[17], theESPEN Guideline SOPis based on the well-established Scot-tish methodology presented on the websites of the Scottish Inter-collegiate Guidelines Network (SIGN)[18],aswellasonthesimilar British methodology presented on the websites of the Na-tional Institute for Health and Care Excellence (NICE)[19]. More-over, we adapted our methodology at some points to the SOP forguidelines authorized by the European Crohn's and Colitis Organi-zation (ECCO)[20], to the GRADE practice on rating quality of evi-dence and strength of recommendations[21], and to the Oxfordmethodology presented at the University of Oxford website of theCentre for Evidence-based Medicine ( ).During project planning, a decision should be made as early aspossible about the planned S class as defined in the AWMF Guid-ance Manual and Rules[17]. The AWMF classification grid is used todifferentiate between the S1 expert recommendations and S2e, S2kand S3 guidelines. Every class stands for a specific methodologicalconcept that should be described in a plausible way for the are meant to indicate the degree to which a guidelinedevelopment process was systematic. The class is selected depend-ing on how much effort is suitable and required to legitimate theimplementation of the guideline and to convince the target , ESPEN guidelines will fulfill the criteria of a S3 guideline that refer to the DELBI instrument[17]and AGREE II ( ):dThe guideline working group should be representative of thetarget users and the participating medical society(ies) and/ororganization(s)dA systematic literature search and selection, including sys-tematic search for guidelines on the same topic to assesswhether individual recommendations can be used and/oradapted, as well as a critical appraisal of the scientific evi-dence with regard to the relevant clinical questions methods are used to search for the evidence, search strategy should be described in detail with a list ofsearch terms and sources used (electronic databases, data-bases of systematic reviews, manually-searched journals,conference proceedings and other guidelines)dThe selection criteria for the evidence are presented explic-itly, especially the exclusion criteriadThe evidence researched and selected according to criteriaestablished a priori is assessed with respect to its method-ological quality and the results are summarized in an evi-dence result of the appraisal allows the strength of the evi-dence ( recommendation grades or grades of evidence )tobe methods for generating (nominal group process or Del-phi method) and establishing consensus-based recommen-dations (consensus conference) are clearly recommendation is discussed and voted on as part of astructured consensus development with a neutral moder-ator. Objectives are tofind a solution to pending decision-making issues, a conclusive appraisal of the recommenda-tions and measure the strength of on the evidence of the existing literature and on theresults of the structured consensus process the grade ofrecommendation A (strong recommendation), B (recom-mendation) or 0 (open recommendation) will guideline will indicate for each recommenda-tion level of evidence (based on study methodology), gradeof recommendation (based on study methodology plusconsistency of results and various aspects of clinical imple-mentation) for each recommendation and strength ofconsensus (>90%,>75%,>50%,<50%)dA description of the methodological strategy (guidelinereport) is attached to the guideline3. Scope of application and aimTheESPEN Guideline SOPis valid and obligatory for all ESPEN-sponsored guideline projects. ESPEN guidelines comprise allconsensus guidelines and position papers on the diagnosis, classifi-cation, or management of malnutrition, disease-related malnutri-tion, and nutrition-related diseases authorized by ESPEN. AllESPEN guidelines and position papers will be reviewed by theESPEN Guidelines Editorial board(GEB) andfinally approved by theESPEN Executive Committee(ExeCom). Exceptions not adhering tothis SOP should be limited to rare cases and need written approvalby the Guideline SOPaims to facilitate the selection andpreparation of guideline projects by ESPEN, to streamline theconsensus process for guidelines, to ensure maximal scientific evi-dence for the recommendations, to increase transparency of theentire process leading to novel guidelines, updates of establishedguidelines or position papers, to prevent delays in the process byimplementing predefined timelines and by facilitating review andapproval, and to facilitate and standardize the dissemination andpublication of ESPEN guidelines and position ESPEN guidelines Editorial board (GEB)The GEB is nominated by the ESPEN ExeCom usually for fouryears ( ). The GEB advisory board consists of up tofive persons,2 chairmen, the ESPEN chairman, and two other experts ( ESPEN ExeCom member, the GEB secretary, a guidelinemethodologist). The GEB members can be renominated for a sec-ond turn by the ESPEN ExeCom. The GEB runs an office consistingof the GEB secretary and headed by the GEB chairman, or by oneof the GEB chairmen, if there are two in action. The GEB supportsand supervises the guideline processes and is responsible for thestrategic planning of guideline activities. Principle decisions suchas approval of a new guideline proposal and other decisions withsubstantialfinancial consequences needs approval not only by theGEB but also by the ESPEN ExeCom. In detail, each guideline is su-pervised by a GEB chairman, who is co-author of the guideline. TheGEB office secretary will coordinate all guideline processes,communication between group members and the GEB and otherparticipating institutions. Moreover, the GEB office secretary willorganize the meetings and voting's for the consensus process,Editorial / Clinical Nutrition 34 (2015) 1043e10511044advise the working group, create the evidence tables and edit themanuscripts in collaboration with the GEB supervisor prior to pub-lication. A map of all guideline projects will be maintained andupdated by the GEB and the ESPEN Submitting a proposal to develop ESPEN guidelinesUnsolicited proposals may be submitted to the ESPEN office ordirectly to the GEB office by any individual ESPEN member or bya group of individuals of whom at least one is an ESPEN member,or by an ESPEN Special interest group (SIG) using a standard form( ).In particular, young ESPEN fellows are encouraged to submit ap-plications for new guidelines. All proposers are asked to enclose aCV and a motivation statement along with their details about the application process are found at theESPEN proposal should describe a short rationale, all topics thatwill be covered, the members of the initial task force and oneresponsible coordinator, the proposed timelines for the consensuswork and for thefinal publication and the estimated budget. Advicecan be sought through the GEB or the ESPEN proposal will be reviewed by the GEB and a recommenda-tion made to the ESPEN ExeCom will be provided within one monthafter receipt of the submission. The ESPEN ExeCom will respondwithin three month in terms of approval, tentative acceptancewith revisions, or disapproval of the proposal. Once approved, theGEB will nominate the responsible coordinator of the group, thegroup members and the GEB supervisor of the group. Furthermore,the GEB will prepare the contract between the group and ESPEN inwhich all details will be proposals can be announced by the GEB afterapproval by the ESPEN ExeCom. Either, open calls can be send toall ESPEN members or announced at the ESPEN website, orselected experts can be contacted and asked for contribution. Inafirst step, the responsible coordinator will be recruited, followedby a second call or recruitment for participants of the group. Thesecond step will be coordinated by the GEB in collaboration withthe group coordinator. All new guideline projects will beannounced at the ESPEN website. Every ESPEN member has thepossibility to ask for joining a guideline group within a giventime frame (usually one month) by writing to the responsibleGEB supervisor with a rationale explaining their expertise(maximum 10 lines, supported by a maximum of 5 key refer-ences). All correspondence can be addressed to the ESPEN office(which will forwarded to the GEB chairs within two weeks) ordirectly to the GEB office or Selection of the working groupThe composition of the working groups should be based on thetopics suggested in the initial proposal, although additional work-ing parties can be added or topics can be merged or readjusted asdeemed appropriate by the GEB. Criteria for selection of workingparty members will primarily depend on academic expertise, butappropriate consideration of gender balance, geographical location,participation in current or previous guideline projects is expected,to avoid the perception of bias. Inclusion of ESPEN members activein SIG's and young ESPEN members is GEB will decide about thefinal composition of the group members will be selected in accordance with theresponsible coordinator and theresponsible GEB supervisor. AGEB chairman acts as GEB supervisor in order to ensure that theguideline project is carried out according to theESPEN the selection process isfinalized, anESPEN declaration ofconflict of interest(COI) form will be sent to all contributors via theESPEN office and only those individuals who have declared theirCOI are entitled to participate in the consensus. Employees of thePharmaceutical Industry are explicitly excluded from the system-atic literature review or meetings of the consensus, even 1. Responsibilities within the ESPEN guideline generation process. At present, the GEB members are Stephan C. Bischoff and Pierre Singer (GEB chairmen), Andr e van Gos-sum (ESPEN chairman), Michael Koller (methodologist), and Tommy Cederholm. For further explanation see / Clinical Nutrition 34 (2015) 1043e105110457. Guideline budgetThe costs of the guidelines will be covered by ESPEN. The use ofan appropriate guideline platform for up to two voting rounds onthe prepared recommendations, and a voting system during thefinal consensus meeting will be provided. Moreover, the officewill support the groups by methodological advice, by creating evi-dence tables and by participating in preparing the manuscript support for consensus projects can only be madethrough unrestricted grants to ESPEN and should be agreed withthe ESPEN ExeCom prior to any commitment. A direct sponsoringof a specific guideline project through industry is not the guideline project is an orchestrated effort involving ESPENand other Scientific Societies/Organizations, the selection processonly applies to the contribution of ESPEN to the project. Other so-cieties and organizations should follow their own , employees of the Pharmaceutical Industry remainexcluded from any guideline project accredited by of the guideline topic, the coordinator and the groupmembers as well as the timeline and the budget plan is milestone1. An overview of all milestones is shown within theflow chart forthe structured generation of ESPEN guidelines (Figs. 2 and 3).8. PICO questions to be answered by the guidelineThefirst stage of EBM is to ask clearly focused questions,because it makes it much easier tofind a reliable answer. Therefore,the guideline process starts by defining the major topics/questionsthat will be addressed by the guideline. This process is done withinthe guideline group under the leadership of the responsible guide-line benefit patients and clinicians, well-built clinical questionsneed to be both directly relevant to patients' problems and phrasedin ways that direct the search to relevant and precise answers. Inpractice, such questions usually contain four elements, (i)patientor problem-based question, such as what is the target group,what is the problem; (ii)intervention-related question, whatis the action such as advice, counseling, treatment, (iii) acompari-son of intervention, if necessary, in comparison to standardtherapy alone, and (iv)outcome-related question or topic, body weight, morbidity, length of stay, or quality of life(Table 1). The four elements have been abbreviated by the lettersPICO, and the questions generated by this way are namedPICOquestions. At the University of Oxford website, an example is pro-vided how to formulate a search question using the PICO system( ).Once the list of topics and the PICO questions have beenapproved within the group, they will be sent to the GEB group su-pervisor together with the search key words forfinal approval(milestone 2).9. Literature searchBefore starting with the classical literature search, one shouldlook for secondary sources such as published valid guidelines( NICE, SIGN; US National Guidelines Clearinghouse, guidelinesof European or international societies in thefield) and systematicreviews ( Cochrane Library, see ).Next, a search for primary sources is required ( PubMed) us-ing methodologicalfilters to target the right type of study ( ther-apy, diagnosis, prognosis, etiology). The development of guidelinerecommendations and the supporting text should always includea systematic literature search with the appropriate key words usingMedline/Pubmed and other databases. Thesearch key wordsandFig. 2. Flow chart for the structured generation of an ESPEN guideline. The proce-dure consists of 10 milestones. Further explanation in the / Clinical Nutrition 34 (2015) 1043e10511046the results retrieved thereby must be documented. If required bythe group coordinator, the GEB office can assist in performing thesearch, or even perform it according to thePICO questionsand thesearch key wordsprovided by the working group (milestone 3).10. Classification of the literature according to evidence levelsThe result of the literature search is sent back to the workinggroup for selection and analysis of the literature of relevance forthe recommendations. Usually, the appropriate literature will beselected by the group coordinator from the search result andcategorized into clinical trials relevant for the recommendations,and other publications required for the supporting text of theguideline. The selection process requires appropriate documenta-tion. Only the publications that are thought to be of relevance forthe recommendations need to be classified according to anevi-dence level(EL) standard. The EL is the major basis for therecom-mendation grade(RG) each recommendation has to be variety of classification systems are available for assigning ELof existing studies among which the most popular ones are theOxford classification dated 2009 ( 1025), the SIGN classification 1999e2012 ( ), and the GRADE system( ). The Oxford and SIGNclassification systems focus on the quality of the individualstudies. The GRADE approach views the available evidence fromthe outcome perspective (critical appraisal of the body of evi-dence from the studies for each relevant endpoint)[17].For the ESPEN guidelines we use the SIGN classification for EL(Table 2) and RG (Table 3). The only substantial difference betweenthe SIGN and the Oxford classification for EL is that the Oxford clas-sification distinguishes between cohort studies (level 2) and case-econtrol studies (level 3), whereas SIGN merges the two levels toone. Therefore, the Oxford classification consists of 5 levels, theSIGN classification of 4. In order to make the process as simple aspossible, we selected the SIGN classification for EL. Also regardingRG, the SIGN and the Oxford classification are almost identical,except that the SIGN classification system offers apart from theclassical three class grading (A/B/0) the category Good practicepoints (GPP), also named expert consensus , which recommendsbest practice based on the clinical experience of the guidelinedevelopment. This category is of particular importance infieldslike nutrition, in which relevant questions are not always coveredby appropriate trials, because of ethical reasons or methodolog-ical limitations such as impossibility of blinding the interventionproducts. Finally, SIGN offers apart from the grades of recommen-dations also forms of recommendation that classify recommenda-tions into strong (A) and conditional recommendation (B) againstor for something, respectively, which might me even more relevantfor the user that the classical grading the University of Oxford website, Critical Appraisal Work-sheets are available supporting the analysis of systematic reviews,diagnosis and therapy papers as well as clinical trial publications( ). Alternatively, the SIGNchecklists can be used, which are available for systematic reviewsand meta-analyses, randomized controlled trials, cohort studies,caseecontrol studies, diagnostic studies, and economic studies( ).In this context, it is strongly recommended to calculate theNumber Needed to Treat(NNT) to better estimate the relevance ofthe result. The NNT is the number of patients one need to treat toprevent one additional bad outcome (death, infection, etc.). Tocalculate the NNT, one needs to know theAbsolute Risk Reduction(ARR), which is defined as ARR CER (Control Event Rate) EER(Experimental Event Rate). The NNT is the inverse of the ARR(NNT 1/ARR) and is always rounded up to the nearest wholenumber[22]. Sometimes, odds ratios (ORs) are indication in publi-cations instead of event rates or NNT. In this case, a formula for con-verting ORs to NNTs can be used: NNT (1 (PEER*(1 OR)))/((1 PEER)*(PEER)*(1 OR)), whereas PEER stands for patient's ex-pected event rate if they receive the control literature selection is done by the working group coordi-nator, the attribution of EL for those publications marked as rele-vant for the recommendations is done by the GEB officeaccording to the SIGN classification (milestone 4).Fig. 3. Flow chart for the structured generation of an ESPEN guideline based on anexisting valid guideline (shorted procedure). The shorted procedure consists of 8milestones. Further explanation in the / Clinical Nutrition 34 (2015) 1043e1051104711. Consensus procedureBased on the PICO questions and the selected literature, theworking groups will generate afirst draft of , this procedure can be divided into working subgroupsformed by the group coordinator(s). Finally, the recommendationshave to be approved by the whole working recommendation is defined as a statement that contains acourse of action such as a diagnostic procedure or a preventive ortreatment activity. Recommendations should contain the verbscan/may (RG 0), should (RG B), or shall (RG A) depending on therecommendation grade. The recommendations will be presentedwith standardized naming and consecutive numbering, ESPEN-XXX Recommendation 1 .The recommendations need to be graded according to the SIGNRGs and recommendation forms (Table 3). Moreover, the recom-mendations should be attributed to one out offive outcome models(Table 4) according to Koller et al.[23]. These models haveTable 1The PICO question or problemIntervention (a cause, prognosticfactor, treatment, etc.)Comparison intervention(if necessary)OutcomesPICOTips forBuildingDefine the patient target group ( with liver cirrhosis) or theproblem ( mal-nutrition in the ICU)Balance precision with the type of intervention( nutrition counseling, oralnutrition supplement, enteral/parenteral nutrition). Be What is the main alternativeto compare with the intervention? The alternative can be usual careor an alternative What can I hope to accomplish? or What could this exposure reallyaffect? , for example weight gain,improvement of quality of life,reduction of In patients with stable ...would adding an oralnutrition supplement tostandard nutrition ...when compared with standardcare ...lead to lower mortality ormorbidity from malnutrition. Modified from Asking Focused Questions. Centre for Evidence-based medicine. University of Oxford ( ).Table 2Levels of High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias1 Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias1 Meta-analyses, systematic reviews, or RCTs with a high risk of bias2 High quality systematic reviews of case control or cohort or studies. High quality case control or cohort studies with a very low risk of confounding orbiasand a high probability that the relationship is causal2 Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal2 Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal3Non-analytic studies, case reports, case series4Expert opinionAccording to the Scottish Intercollegiate Guidelines Network (SIGN) grading system. Source: SIGN 50: A guideline developer's handbook. Quick reference guide October 2014[19].Table 3Grades and forms of Grades of recommendationaAAt least one meta-analysis, systematic review, or RCT rated as 1 , and directly applicable to the target population; orA body of evidence consisting principally of studies rated as 1 , directly applicable to the target population, and demonstrating overall consistency of resultsBA body of evidence including studies rated as 2 , directly applicable to the target population; orA body of evidence including studies rated as 2 , directly applicable to the target population and demonstrating overall consistency of results; oranddemonstrating overall consistency of results; orExtrapolated evidence from studies rated as 1 or 1 0Evidence level 3 or 4; orExtrapolated evidence from studies rated as 2 or 2 GPPGood practice points/expert consensus: Recommended best practice based on the clinical experience of the guideline development groupb. Forms of recommendationbJudgmentRecommendationUndesirable consequences clearly outweigh desirable consequencesStrong recommendation againstUndesirable consequences probably outweigh desirable consequencesConditional recommendation againstBalance between desirable and undesirable consequences is closely balanced or uncertainRecommendation for research and possibly conditionalrecommendation for use restricted to trialsDesirable consequences probably outweigh undesirable consequencesConditional recommendation forDesirable consequences clearly outweigh undesirable consequencesStrong recommendation foraThere is not necessarily a 1:1 relation between grade of recommendation (A,B,0) and the quality of the evidence. Grade of recommendation should also take into accountcriteria such as consistency of study results, clinical relevance of endpoints (outcomes) and effect sizes, risk-benefit ratio, patient preferences, application to the relevantpatient group, application to health care setting, legal and economic considerations. Based on these criteria, upgrading or downgrading of grades of recommendation from the Scottish Intercollegiate Guidelines Network (SIGN) grading system. Source: SIGN 50: A guideline developer's handbook. Quick referenceguide October2014[19].Editorial / Clinical Nutrition 34 (2015) 1043e10511048substantial implications for evaluating trials in clinical nutritionand comprise biomedical, patient-centered/-reported, health eco-nomic, decision-making, and integration of classical and patient-reported endpoints. Most published studies in thefield of clinicalnutrition make use of biomedical endpoints, but the growingimportance of patient-centered/-reported and health economicoutcomes is recognized. Therefore, ESPEN guidelines will not onlyfocus on biomedical endpoints in clinical nutrition studies, when-ever detail, the working group has to deliver (i) the recommenda-tion, (ii) the literature on which the recommendation is based on,(iii) the grade and form of recommendation, (iv) the attributedoutcome model. These materials have to be sent to the GEB office(milestone 5).To facilitate the discussion among the working group and toquantify opinions among all working group members and other ex-perts an online guideline platform that will be maintained by theGEB office will be used for all guideline projects. Usually, one ortwo rounds of online voting will be performed. Thefirst roundwill take place afterfinalization of the recommendations and willinvolve all participants of the working group including the GEB su-pervisor. Participants that do not participate in the online votingprocess within the given time frame may be excluded from theguideline project. The feedback from thefirst online voting willbe used to modify and improve the initial recommendations in or-der to reach the highest degree of acceptance at the second onlinevoting and thefinal consensus meeting. Alternatively, thefirst on-line voting can be replaced by a physical meeting of the group fordiscussion and voting. The results have to be sent to the GEB office(milestone 6). If the guideline is prepared based on an existing validnational guideline, milestone 6 (1st voting) can be Supporting textA supporting text (also called background text) by the detailedevidence from the literature is composed by the working group,or optionally by working subgroup if applicable. The supportingtext should be submitted as a MS Word document with references,the references should be also be provided as afile in a referenceprogram (Endnote or Reference Manager) to allow rapid mergingof manuscripts from different working subgroups, and inclusionof updates and modifications of the manuscript by the guidelinecoordinator (not by the GEB office).Best practice has a timeline that requires a complete draft ofsupporting text submitted to the GEB monitor of the guideline proj-ect prior to the second online voting, latest prior to the consensuspanel. This is often most readily achieved by ensuring that thegroup coordinator is tasked to write thisepossibly based on theinput from the working subgroups. In any case, thefinal editingof the text is done by the responsible coordinator of the supporting text should be concise and should focus onrelevant publications to support the evidence of therecommendations. If necessary, a few additional publicationscan be cited to support and explain the supporting text. It shouldnot provide an extensive review of the literature. Generally, aguideline manuscript should not exceed more that 15,000 wordswithout references, and not more than 100 recommendations. Ex-ceptions need approval by the GEB and the Editor-in-Chief ofClin-ical Nutrition. A supporting text should be usually not longer than250 words and should not contain more than 10 references (usu-ally 3e6 references). The complete supporting text with the rec-ommendations has to be sent to the GEB supervisor and the GEBoffice (milestone 7). If the guideline is prepared based on an exist-ing valid national guideline, milestone 7 can be omitted providedthat the recommendations will be provided together with thesupporting text within milestone second online voting round (first voting round in case ofguideline prepared based on an existing guideline) will then takeplace once the background/supporting text with references comeavailable. In addition to all the working group members, the ESPENcouncil members and those ESPEN members that applied for theguideline but were rejected due to space limitations will beinvolved in this online voting. The results will be classified intofour classes (Table 5). The feedback of the second online votinground will again be used to modify and improve the recommenda-tions in order to reach the highest degree of acceptance at thefinalconsensus meeting or to make voting dispensable at thefinalconsensus meeting. If the guideline group feels that suggestionsare inappropriate and no further amendments are needed, recom-mendations may stay unchanged. In contrast to thefirst onlinevoting, the second online voting is obligatory. The revised text af-ter the second online voting has to be sent to the GEB office (mile-stone 8).13. Consensus conferenceAfinal consensus meeting will take place after the second onlinevoting round and after the supporting test has been completed. AllESPEN members that were involved in the guideline should aim toattend this meeting. There will be only one consensus meeting perESPEN guideline project. All recommendations will be presentedthere. All recommendations with more than 75% agreement inthe second online voting round do not need any additional votingin the consensus panel meeting. All recommendations with lessthan 75% agreement will be voted upon and may be modified ac-cording to the feedback of the consensus panel members in orderto achieve a higher degree of with more than 75% of agreement in thefinalconsensus meeting or the second online voting round are acceptedasfinal consensus recommendations. Those with less than 50%agreement in thefinal consensus meeting are rejected, as therehas been no majority among the experts. Those recommendationswith 50e75% agreement represent a majority vote which shouldresult in a downgrading of the recommendation grade. Thefinalpublication should explain the full process by which ConsensusTable 4Outcome models in clinical with implications for evaluating trials in clinical nutritionExamplesBiomedical endpoint (BM) improvement of body weight, body composition, morbidity, mortalityPatient-centered/-reported endpoint (PC) validated quality-of-life scoreHealth economic endpoint (HE) QALYs or budget savingsDecision-making endpoint (DM) clinical parameters or biomarkers that allow to make a clinically relevant decisionsuch as transfer from ICU to a normal ward or nutritional support yes/noIntegration of classical and patient-reported endpoint (IE)The combination of BM and PC, complex scores such as the Frailty IndexAdapted from Koller et al.[23].Editorial / Clinical Nutrition 34 (2015) 1043e10511049was obtained, the methods used to search the literature and howconsensus was reached and how this was set of guideline recommendations once accepted at theconsensus meeting isfinal and is not open to further change byany process other than reconvening the SOPs for ESPEN-authorized guidelines (as of Jan. 6th, 2015). A copy of thefinal setof recommendations, together with thefinal supporting text andthe references marked as relevant for the recommendation ornot, needs to be submitted to the GEB chairs and the GEB office(milestone 9).The guideline group members as well as any other involved per-son are not allowed to make recommendations available or visibleoutside the consensus panel. Exceptions need written approval bythe GEB office will create the evidence table based on the mate-rials obtained from the guideline group coordinator. Provided thatthe materials are complete, the GEB office will complete the evi-dence table usually within one month, at maximum within Finalization of the manuscript and publicationAll ESPEN guidelines will be published in the ESPEN journal,which is currentlyClinical Nutrition. Dual publications should begenerally avoided. A careful discussion with the Editor-in-Chief ofClinical Nutritionis necessary at the earliest opportunity andexpressly before any agreement is reached or any memorandumof understanding is signed, before joint guidelines are further pre-ceded. If publication is not resolved before the start of the Guidelineprocess, then misunderstandings are common that may be verydifficult to resolve at a later date. All variation of this policy needsapproval by the , one paper per guideline should be prepared, excep-tions need approval by the GEB and the Editor-in-Chief ofClinicalNutrition. The readability of a large guideline is usually improvedby structuring the guideline into different chapters with consecu-tive numbering. Each manuscript starts with a title page and a con-tent. An introduction with a brief outline of the methods andcriteria that have been used, and how authors were selected shouldbe present in all ESPEN consensus papers. It can refer to publishedmethodology that will be published separately by the GEB chairswith the support of the GEB the contributing consensus participants will be acknowl-edged in a list of contributors. A maximum of 15 participants canbe included as authors on a guideline paper. Exceptions needapproval by the GEB and the Editor-in-Chief ofClinical , the group coordinator will be thefirst and correspond-ing author, and the group supervisor who is one of the GEB chair-men will be the last author. The group coordinator will propose theco-authors from the working group. Each paper should be signedby the coordinator and corresponding authors (usually thesame). All work subgroup leaders will appearfirst (if applicable)and other group members will appear in alphabetical of guidelines is best agreed in advance within theworking group. If the working group was leaded by two coordina-tors who have contributed equally, this can be denoted by anasterisk. In case of conflict, the GEB will decide about the author-ship texts should be sent back to all authors forfinal approval(allowing at least two weeks for review). The GEB office and theGEB chairs will cross-read all manuscripts before they are sendto the journal Editor. At this step, the format will be counter-checked to ensure a consistent layout of all ESPEN guidelines. Incase of major changes, the working group coordinator will beasked to approve thefinal version within one week. Then, theGEB office will sent the guideline forfinal approval to the ESPENExeCom and to the presidents of other societies, if other societiesare involved. If no formal objection is obtained within two weeks,the GEB office will send the paper to the journal Editor (milestone10).All ESPEN-sponsored and approved guideline and position pa-pers have to be published inClinical Nutritionand Open Access toall guideline papers will be guaranteed by ESPEN and the publisherofClinical Nutritionwithout charge. Exemptions will requireapproval by the ESPEN ExeCom, the GEB and the coordinator ofthe guideline. Also for joint guidelines with other societies a singleguideline paper should be aimed for and it should be published inClinical Nutrition. Dual publications should be generally avoided,but can be considered as rare guideline recommendations are not eligible for external re-view, neither by peer reviewers, nor by ESPEN corporate remain the property of ESPEN, or (in the case of jointly spon-sored guidelines) the joint property of ESPEN and the Word documentfile and afinal Endnotefile with themost recent and submitted version of the manuscript and thereferences needs to be submitted to the GEB and the ESPEN officefor storage. Thesefiles can be used for future updates of guide-lines and may substantially facilitate the work on Implementation and updateIn order to ensure the implementation of ESPEN guidelines anumber of activities are Careful examination of the guideline for clarity of language andformat2. Proofreading by a representative from a patient's organization3. Presentation of the guideline in different formats (full format forexperts, short format for practitioners, easy-to-read format forpatients) and media (print and website)4. Supplementation of the guideline with algorithms, care path-ways, and electronic decision support tools5. Linking the guideline with related organizations andstakeholders6. Dissemination of the guidelines via slide sets, oral presentations,and teaching lessons ( national conferences, LLL education,etc.)In order to ensure timeliness of ESPEN guidelines, they will beupdated at regular intervals (usually every 3e4 years, latest after5 years).The need for continuous supplementation and updating of aguideline is not only a function of the availability of new andemerging scientific knowledge, but also depends on the results ob-tained from an analysis of the guideline's previous usage. The latterhelps to identify potentials for improvement. The methodologicalrequirements are specified in the DELBI instrument and the guide-line requirements described in the AWMF Guidance Manual[17].Table 5Classification of the strength of consensusAgreement of>90% of the participantsConsensusAgreement of>75e90% of the participantsMajority agreementAgreement of>50e75% of the participantsNo consensusAgreement of<50% of the participantsAccording to the AWMF methodology[17].Editorial / Clinical Nutrition 34 (2015) 1043e10511050Conflict of interestNone [1]Plauth M, Merli M, Kondrup J, Weimann A, Ferenci P, Muller MJ. ESPEN guide-lines for nutrition in liver disease and transplantation. Clin Nutr 1997;16:43e55.[2]Toigo G, Aparicio M, Attman PO, Cano N, Cianciaruso B, Engel B, et al. ExpertWorking Group report on nutrition in adult patients with renal insufficiency(part 1 of 2). Clin Nutr 2000;19:197e207.[3]Toigo G, Aparicio M, Attman PO, Cano N, Cianciaruso B, Engel B, et al. ExpertWorking Group report on nutrition in adult patients with renal insufficiency(part 2 of 2). Clin Nutr 2000;19:281e91.[4]Meier R, Beglinger C, Layer P, Gullo L, Keim V, Laugier R, et al. ESPEN guide-lines on nutrition in acute pancreatitis. Clin Nutr 2002;21:173e83.[5]Kondrup J, Allison SP, Elia M, Vellas B, Plauth M. ESPEN guidelines for nutritionscreening 2002. Clin Nutr 2003;22:415e21.[6]Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gomez JM, et guidelines for bioelectrical impedance analysis (part 1: review of prin-ciples and methods). Clin Nutr 2004;23:1226e43.[7]Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gomez JM, et guidelines for bioelectrical impedance analysis (part 2: utilization inclinical practice). Clin Nutr 2004;23:1430e53.[8]L oser C, Aschl G, H ebuterne X, Mathus-Vliegen EMH, Muscaritoli M, Niv Y,et al. ESPEN guidelines on enteral nutritiondpercutaneous endoscopic gastro-stomy (PEG). Clin Nutr 2005;24:848e61.[9]Koletzko B, Goulet O, Hunt J, Krohn K, Shamir R, Parenteral Nutrition Guide-lines Working Group; European Society for Clinical Nutrition and Metabolism;European Society of Paediatric Gastroenterology, Hepatology and Nutrition(ESPGHAN); European Society of Paediatric Research (ESPR). Guidelines onPaediatric Parenteral Nutrition of the European Society of Paediatric Gastroen-terology, Hepatology and Nutrition (ESPGHAN) and the European Society forClinical Nutrition and Metabolism (ESPEN), Supported by the European Soci-ety of Paediatric Research (ESPR). J Pediatr Gastroenterol Nutr 2005;41( ):S1e87.[10]Lochs H, Valentini L, Sch tz T, Allison SP, Howard P, Pichard C, et al. ESPENguidelines on adult enteral nutrition. Clin Nutr 2006;25:177e360.[11]Cano NJM, Aparicio M, Brunori G, Carrero JJ, Cianciaruso B, Fiaccadori E, et guidelines for adult parenteral nutrition. Clin Nutr 2009;28:359e479.[12]Gustafsson UO, Scott MJ, Schwenke W, Demartines N, Roulin D, Francis N,et al. Guidelines for perioperative care in elective colonic surgery: EnhancedRecovery After Surgery (ERAS) Society recommendations. Clin Nutr2012;31:783e800.[13]Nygren J, Thacker J, Carli F, Fearon KCH, Norderval S, Lobo DN, et al. Guidelinesfor perioperative care in elective rectal/pelvic surgery: Enhanced Recovery Af-ter Surgery (ERAS) Society recommendations. Clin Nutr 2012;31:801e16.[14]Lassen K, Coolsen MME, Slim K, Carli F, de Aguilar-Nascimento JE, Sch afer M,et al. Guidelines for perioperative care for pancreaticoduodenectomy:Enhanced Recovery After Surgery (ERAS) Society recommendations. ClinNutr 2012;31:817e30.[15]Rousseau AF, Losser MR, Ichai C, Berger MM. ESPEN endorsed recommenda-tions: nutritional therapy in major burns. Clin Nutr 2013;32:497e502.[16]Preiser JC, Schneider SM. ESPEN disease-specific guideline framework. ClinNutr 2011;30:549e52.[17] German Association of the Scientific Medical Societies (AWMF)eStandingGuidelines Com-mission. AWMF guidance manual and rules for guidelinedevelopment. 1st ed. 2012 English version. Available at: [accessed on ].[18] Scottish Intercollegiate Guidelines Network (SIGN). SIGN 50: a guideline de-veloper's handbook. Revised version. Edinburgh: SIGN; 2014. Available fromURL: [19] National Institute for Health and Clinical Excellence. The guidelines : National Institute for Health and Clinical Excellence; November2012. Available [20]Dignass Axel, Annese Vito, Eliakim Abraham, Magro Fernando, Gassull Miquel,Travis Simon, et al. Standard operating procedures (SOPs) for ECCO authorisedguidelines and position papers. European Crohn's and Colitis Organization(ECCO); Feb 14th, 2013.[21]Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P,et al., GRADE Working Group. GRADE: an emerging consensus on ratingquality of evidence and strength of recommendations. BMJ 2008;336:924e6.[22]Zapletal E, LeMaitre D, Menard J, Degoulet P. The number needed to treat: aclinically useful nomogram in its proper context. BMJ 1996;312:426e9.[23]Koller M, Sch tz T, Valentini L, Kopp I, Pichard C, Lochs H, Clinical NutritionGuideline Group. Outcome models in clinical studies: implications fordesigning and evaluating trials in clinical nutrition. Clin Nutr 2013;32 C. Bischoff*Institute of Nutritional Medicine, University of Hohenheim, Stuttgart,GermanyPierre SingerDepartment of General Intensive Care and Institute for NutritionResearch, Rabin Medical Center, Beilinson Hospital, Tel AvivUniversity, Petah Tikva, IsraelE-mail KollerCenter for Clinical Studies, University Hospital Regensburg,Regensburg, GermanyE-mail BarazzoniDepartment of Medical, Surgical and Health Sciences, University ofTrieste, ItalyE-mail CederholmDepartment of Clinical Nutrition and Metabolism, Uppsala University,Uppsala University Hospital, Uppsala, SwedenDepartment of Geriatric Medicine, Uppsala University Hospital,Uppsala, SwedenE-mail e van GossumDepartment of Gastroenterology, Erasme Hospital, Universit e Libre deBruxelles, Brussels, BelgiumE-mail author. Institute of Nutritional Medicine,University of Hohenheim, 70593 Stuttgart, Germany. Tel.: 49 711459 24101; fax: 49 711 459 Bischoff).1 July 2015Editorial / Clinical Nutrition 34 (2015) 1043e10511051

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