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Background Systematic reviews often conclude low confidence in the results due to heterogeneity in the reported outcomes. A Core Outcome Set (COS) is an agreed standardised collection of outcomes for a specific area of health. The outcomes included in a COS are to be measured and summarized in clinical trials as well as systematic reviews to counteract this heterogeneity. Aim The aim is to identify, compile and assess final and ongoing studies that are prioritizing outcomes in the area of pregnancy and childbirth. Methods All studies which prioritized outcomes related to pregnancy and childbirth using consensus method, including Delphi surveys or consensus meetings were included. Searches were conducted in Ovid MEDLINE, EMBASE, PsycINFO, Academic Search Elite, CINAHL, SocINDEX and COMET databases up to June 2021. For all studies fulfilling the inclusion criteria, information regarding outcomes as well as population, method, and setting was extracted. In addition, reporting in the finalized studies was assessed using a modified version of the Core Outcome Set-STAndards for Reporting. Results In total, 27 finalized studies and 42 ongoing studies were assessed as relevant and were included. In the finalized studies, the number of outcomes included in the COS ranged from 6 to 51 with a median of 13 outcomes. The majority of the identified COS, both finalized as well as ongoing, were relating to physical complications during pregnancy. Conclusion There is a growing number of Core Outcome Set studies related to pregnancy and childbirth. Although several of the finalized studies follow the proposed reporting, there are still some items that are not always clearly reported. Additionally, several of the identified COS contained a large number (n > 20) outcomes, something that possibly could hinder implementation. Therefore, there is a need to consider the number of outcomes which may be included in a COS to render it optimal for future research.

Background: Research on the identification and treatment of problem gambling has been characterized by a wide range of outcome measures and instruments. However, a single instrument measuring gambling behavior, severity, and specific deleterious effects is lacking. Objective: This protocol describes the development of the Gambling Disorder Identification Test (G-DIT), which is a 9-to 12-item multiple-choice scale with three domains: gambling consumption, symptom severity, and negative consequences. The scale is analogous to the widely used Alcohol Use Disorders Identification Test (AUDIT) and the Drug Use Disorders Identification Test (DUDIT). Methods: The G-DIT is developed in four steps: (1) identification of items eligible for the G-DIT from a pool of existing gambling measures; (2) presentation of items proposed for evaluation by invited expert researchers through an online Delphi process and subsequent consensus meetings; (3) pilot testing of a draft of the 9- to 12-item version in a small group of participants with problem gambling behavior (n= 12); and (4) evaluation of the psychometric properties of the final G-DIT measure in relation to the existing instruments and self-reported criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), among individuals with problem gambling and nonproblematic recreational gambling behaviors (n= 600). This protocol article summarizes step 1 and describes steps 2 and 3 in detail. Results: As of October 2018, steps 1-3 are complete, and step 4 is underway. Conclusions: Implementation of this online Delphi study early in the psychometric development process will contribute to the face and construct validity of the G-DIT. We believe the G-DIT will be useful as a standard outcome measure in the field of problem gambling research and serve as a problem-identification tool in clinical settings., REGAPS

Background: Entrustable Professional Activities (EPAs) have emerged as a new approach to operationalise the workplace performance expectations for the transition from under- to postgraduate medical training. However, the transferability of such EPAs from one context to another appears limited. In this article, we report on the results of our approach to define a full set of core EPAs for entry into residency with the expectation to be performed under distant supervision. Methods: The EPA development involved a modified, three round Delphi study, conducted at the Charité - Universitätsmedizin Berlin. The supervision level was operationalised as supervisor being distantly available and findings being reviewed. The threshold for consent was reaching a content validity index of a least 80%. The Delphi study involved experienced physicians (n=45) and resulted in a set of core EPAs with the descriptions of the categories: title, specification/limitations, conditions and implications of entrustment decision, knowledge, skills, and attitude, link to competencies and assessment sources. Results: The response rates were 76-80% in the Delphi rounds. Key to the content validation process for the performance expectation was deciding on "to act under distant supervision". The results are full descriptions of 12 core EPAs, organised into 5 overarching EPA domains. Conclusions: Our systematic approach yielded the definition of 12 core EPAs for entry into residency at the level of "act with distant supervision" according to the practice in our context. This report may support other medical schools who plan to implement EPAs into their curricula., Hintergrund: Entrustable Professional Activities (EPAs) haben sich als ein neues Konzept etabliert, um die Erwartungen an ärztliche Berufsanfänger am Arbeitsplatz zu operationalisieren. Die Übertragbarkeit von EPAs von einem auf den anderen Kontext ist nur begrenzt möglich. In diesem Artikel berichten wir über die Ergebnisse unseres Vorgehens, ein komplettes Set an Kern-EPAs zu entwickeln, die ärztliche Berufsanfänger unter entfernter Aufsicht ausführen können sollten.Methode: Die Entwicklung der EPAs erfolgte mittels einer modifizierten, aus 3 Runden bestehenden Delphi-Studie an der Charité - Universitätsmedizin, Berlin. Als Aufsichtsgrad wurde festgelegt, dass supervidierende Ärzte mit zeitlicher Verzögerung zur Verfügung stehen und Wichtiges nachgeprüft wird. Ein Content Validity Index von mindestens 80% wurde als Grenze für den Konsens festgelegt. Die Delphi-Studie wurde mit erfahrenen Ärzten durchgeführt (n=45) und resultierte in ein Set von EPAs, die jeweils folgende Kategorien beinhalten: Titel; Spezifikationen/Limitationen; Bedeutung der Entrustment-Entscheidung; Kenntnisse, Fertigkeiten und Haltungen; Kompetenzbereiche und Assessment.Ergebnisse: Der Rücklauf in den Delphi-Runden lag zwischen 76-80%. Voraussetzung für den inhaltlichen Validierungsprozess der Kerntätigkeiten war die Festlegung des Supervisionslevels auf "unter entfernter Aufsicht handeln". Die Ergebnisse sind vollständige Beschreibungen von 12 EPAs, eingeordnet in 5 übergeordnete EPA-Domänen.Schlussfolgerungen: Unser systematisches Vorgehen ergab die Definition von 12 Kern-EPAs für ärztliche Berufsanfänger mit dem Aufsichtsgrad "unter entfernter Aufsicht handeln" für die Anwendung in unserem Kontext. Dieser Bericht soll andere medizinische Fakultäten unterstützen, die eine Implementierung von EPAs in ihre Curricula planen.

Objective To develop new classification criteria for systemic lupus erythematosus (SLE) jointly supported by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). Methods This international initiative had four phases. (1) Evaluation of antinuclear antibody (ANA) as an entry criterion through systematic review and meta-regression of the literature and criteria generation through an international Delphi exercise, an early patient cohort and a patient survey. (2) Criteria reduction by Delphi and nominal group technique exercises. (3) Criteria definition and weighting based on criterion performance and on results of a multi-criteria decision analysis. (4) Refinement of weights and threshold scores in a new derivation cohort of 1001 subjects and validation compared with previous criteria in a new validation cohort of 1270 subjects. Results The 2019 EULAR/ACR classification criteria for SLE include positive ANA at least once as obligatory entry criterion; followed by additive weighted criteria grouped in seven clinical (constitutional, haematological, neuropsychiatric, mucocutaneous, serosal, musculoskeletal, renal) and three immunological (antiphospholipid antibodies, complement proteins, SLE-specific antibodies) domains, and weighted from 2 to 10. Patients accumulating ≥10 points are classified. In the validation cohort, the new criteria had a sensitivity of 96.1% and specificity of 93.4%, compared with 82.8% sensitivity and 93.4% specificity of the ACR 1997 and 96.7% sensitivity and 83.7% specificity of the Systemic Lupus International Collaborating Clinics 2012 criteria. Conclusion These new classification criteria were developed using rigorous methodology with multidisciplinary and international input, and have excellent sensitivity and specificity. Use of ANA entry criterion, hierarchically clustered and weighted criteria reflect current thinking about SLE and provide an improved foundation for SLE research.

[Background and aim] The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) aims to further develop its role in international medical and scientific guidance in the field of Clinical Microbiology and Infectious Diseases, where many types of guidance documents exist. The ESCMID Executive Committee and the Clinical Microbiology and Infection (CMI) editorial board wish to clarify the terminology and format to be used in ESCMID guidance documents submitted for publication in CMI, and to highlight the principles behind ESCMID guidance documents. [Types of guidance documents] There are five types of ESCMID guidance documents: White Papers, Clinical Practice Guidelines, Consensus Statements, State-of-the-Science Statements, and Position Papers. They differ in scope, methods of development, drafting group composition and preferred publication format. Guidance documents can be proposed, developed and published by ESCMID Study Groups, Committees and individual members; often, other scientific societies are involved. The full disclosure of potential conflicts of interest of all drafting group members is a requirement. [Final remarks] Guidance documents constitute a common cultural and scientific background to people in the same and related professions. Also, they are an important educational and training tool. Developing a guidance document is a scientific endeavour, where a sound and transparent development process is needed, requiring multidisciplinary and personal skills.

We present a consensus algorithm for detection of somatic mutations in cancer genomics data, based on integrating results of four published somatic mutation callers, MuTect2, MuSE, Varscan2 and Somatic Sniper. We generate consensus lists of cancer somatic mutations by using a simple voting mechanisms. Performances of cancer somatic mutations searching algorithms are verified by a quality index defined by the estimated proportion between driver and passenger mutations. We demonstrate, on the basis of three large NGS datasets from the TCGA database, that our consensus algorithm improves detection of cancer somatic mutations.

Introduction. There is a limited body of research in the field of healthcare improvement science (HIS). Quality improvement and ‘change making’ should become an intrinsic part of everyone’s job, every day in all parts of the healthcare system. The lack of theoretical grounding may partly explain the minimal transfer of health research into health policy. Methods. This article seeks to present the development of the definition for healthcare improvement science. A consensus method approach was adopted with a two-stage Delphi process, expert panel and consensus group techniques. A total of 18 participants were involved in the expert panel and consensus group, and 153 answers were analysed as a part of the Delphi survey. Participants were researchers, educators and healthcare professionals from Scotland, Slovenia, Spain, Italy, England, Poland, and Romania. Results. A high level of consensus was achieved for the broad definition in the 2nd Delphi iteration (86%). The final definition was agreed on by the consensus group: ‘Healthcare improvement science is the generation of knowledge to cultivate change and deliver person-centred care that is safe, effective, efficient, equitable and timely. It improves patient outcomes, health system performance and population health.’ Conclusions. The process of developing a consensus definition revealed different understandings of healthcare improvement science between the participants. Having a shared consensus definition of healthcare improvement science is an important step forward, bringing about a common understanding in order to advance the professional education and practice of healthcare improvement science.

Background: Employing methods to assess the quality of modeled protein structures is now standard practice in bioinformatics. In a broad sense, the techniques can be divided into methods relying on consensus prediction on the one hand, and single-model methods on the other. Consensus methods frequently perform very well when there is a clear consensus, but this is not always the case. In particular, they frequently fail in selecting the best possible model in the hard cases (lacking consensus) or in the easy cases where models are very similar. In contrast, single-model methods do not suffer from these drawbacks and could potentially be applied on any protein of interest to assess quality or as a scoring function for sampling-based refinement.Results: Here, we present a new single-model method, ProQ2, based on ideas from its predecessor, ProQ. ProQ2 is a model quality assessment algorithm that uses support vector machines to predict local as well as global quality of protein models. Improved performance is obtained by combining previously used features with updated structural and predicted features. The most important contribution can be attributed to the use of profile weighting of the residue specific features and the use features averaged over the whole model even though the prediction is still local.Conclusions: ProQ2 is significantly better than its predecessors at detecting high quality models, improving the sum of Z-scores for the selected first-ranked models by 20% and 32% compared to the second-best single-model method in CASP8 and CASP9, respectively. The absolute quality assessment of the models at both local and global level is also improved. The Pearson's correlation between the correct and local predicted score is improved from 0.59 to 0.70 on CASP8 and from 0.62 to 0.68 on CASP9; for global score to the correct GDT_TS from 0.75 to 0.80 and from 0.77 to 0.80 again compared to the second-best single methods in CASP8 and CASP9, respectively. ProQ2 is ava, QC 20131016

Introduction: Encouraged by the change in licensing regulations the practical professional skills in Germany received a higher priority and are taught in medical schools therefore increasingly. This created the need to standardize the process more and more. On the initiative of the German skills labs the German Medical Association Committee for practical skills was established and developed a competency-based catalogue of learning objectives, whose origin and structure is described here.Goal of the catalogue is to define the practical skills in undergraduate medical education and to give the medical schools a rational planning basis for the necessary resources to teach them.Methods: Building on already existing German catalogues of learning objectives a multi-iterative process of condensation was performed, which corresponds to the development of S1 guidelines, in order to get a broad professional and political support.Results: 289 different practical learning goals were identified and assigned to twelve different organ systems with three overlapping areas to other fields of expertise and one area of across organ system skills. They were three depths and three different chronological dimensions assigned and the objectives were matched with the Swiss and the Austrian equivalent.Discussion: This consensus statement may provide the German faculties with a basis for planning the teaching of practical skills and is an important step towards a national standard of medical learning objectives.Looking ahead: The consensus statement may have a formative effect on the medical schools to teach practical skills and plan the resources accordingly., Einleitung: Angestoßen durch die Änderung der Approbationsordnung haben die berufspraktischen Kompetenzen in Deutschland eine höhere Priorität erhalten und werden in den medizinischen Fakultäten deswegen vermehrt vermittelt. Dadurch entstand die Notwendigkeit, den Prozess mehr und mehr zu standardisieren. Auf Initiative der deutschsprachigen Skills Labs wurde der GMA-Ausschuss für praktische Fertigkeiten gegründet, der einen kompetenzbasierten Lernzielkatalog entwickelte, dessen Entstehung und Struktur hier beschrieben wird.Ziel des Kataloges ist es, die praktischen Fertigkeiten im Medizinstudium zu definieren und damit den Fakultäten eine rationale Planungsgrundlage für die zur Vermittlung praktischer Fertigkeiten notwendigen Ressourcen zu geben.Methodik: Aufbauend auf schon vorhandenen deutschsprachigen Lernzielkatalogen wurde mittels einem mehrfach iterativem Kondensationsprozesses, der der Erarbeitung von S1-Leitlinien entspricht, vorgegangen, um eine breite fachliche und politische Abstützung zu erhalten. Ergebnisse: Es wurden 289 verschiedene praktische Lernziele identifiziert, die zwölf verschiedenen Organsystemen, drei Grenzbereichen zu anderen Kompetenzbereichen und einem Bereich mit organsystemübergreifenden Fertigkeiten zugeordnet. Sie wurden drei verschiedenen zeitlichen und drei verschiedenen Tiefendimensionen zugeordnet und mit dem Schweizer und dem Österreichischem Pendant abgeglichen. Diskussion: Das vorliegende Konsensusstatement kann den deutschen Fakultäten eine Grundlage zur Planung der Vermittlung praktischer Fertigkeiten bieten und bildet einen wichtigen Schritt zu einem nationalen Standard medizinischer Lernziele.Blick in die Zukunft: Das Konsensusstatement soll einen formativen Effekt auf die medizinischen Fakultäten haben, ihre praktischen Unterrichtsinhalte entsprechend zu vermitteln und die Ressourcen danach zu planen.

Aim: This paper describes the development of nursing practice guidelines for percutaneous coronary intervention (PCI). Background: Clinical practice guidelines (CPGs) supporting PCI nursing care are limited. Method: The National Health and Medical Research Council's (NH&MRC) health and medical practice development guidelines were used for the guideline development process. A panel of experts (clinicians and consumers) attended a consensus conference to review existing evidence. Subsequently, nurses' opinions were identified via an online survey. This was followed by a modified Delphi method was used to refine a draft set of guidelines over two rounds. Results: The consensus conference was attended by 41 participants (39 cardiovascular nurses and 2 consumer representatives). Eight additional members joined the panel for the modified Delphi rounds with 27 participants completing the online survey. The final guideline document consisted of 75 recommendations. Endorsement was then sought from key peak cardiovascular bodies in Australia and New Zealand. Discussion/conclusion: Inconclusive evidence precludes definitive recommendations. Therefore, consultation and consensus are important in developing guidelines to achieve standardised nursing care and monitoring of outcomes.Implications for practice: Nurses play a crucial role in PCI care, yet currently there are limited guidelines to inform practice. This paper describes the method developing clinical practice guideline and deriving consensus.

Consensus methods are increasingly being used in healthcare research, particularly for formulating policy and strategic directions. This paper by Elizabeth Halcomb, Patricia Davidson and Laura Hardaker discusses the issues central to the planning and conduct of the consensus development conference, and offers practical recommendations to researchers intending to use this approach

Background: The reporting of outcomes in clinical trials of subjective tinnitus indicates that many different tinnitus-related complaints are of interest to investigators, from perceptual attributes of the sound (e.g. loudness) to psychosocial impacts (e.g. quality of life). Even when considering one type of intervention strategy for subjective tinnitus, there is no agreement about what is critically important for deciding whether a treatment is effective. The main purpose of this observational study is therefore to develop Core Outcome Domain Sets for the three different intervention strategies (sound, psychological, and pharmacological) for adults with chronic subjective tinnitus that should be measured and reported in every clinical trial of these interventions. Secondary objectives are to identify the strengths and limitations of our study design for recruiting and reducing attrition of participants, and to explore uptake of the core outcomes. Methods: The ‘Core Outcome Measures in Tinnitus: International Delphi’ (COMIT’ID) study will use a mixed methods approach that incorporates input from healthcare users at the pre-Delphi stage, a modified three round Delphi survey and final consensus meetings (one for each intervention). The meetings will generate recommendations by stakeholder representatives on agreed Core Outcome Domain Sets specific to each intervention. A subsequent step will establish a common cross-cutting Core Outcome Domain Set by identifying the common outcome domains included in all three intervention-specific Core Outcome Domain Sets. To address the secondary objectives, we will gather feedback from participants about their experience of taking part in the Delphi process. We aspire to conduct an observational cohort study to evaluate uptake of the core outcomes in published studies at 7 years following core outcome set publication. Discussion: The COMIT’ID study aims to develop a Core Outcome Domain Set that are agreed as critically important fo

Background: The reporting of outcomes in clinical trials of subjective tinnitus indicates that many different tinnitus-related complaints are of interest to investigators, from perceptual attributes of the sound (e.g. loudness) to psychosocial impacts (e.g. quality of life). Even when considering one type of intervention strategy for subjective tinnitus, there is no agreement about what is critically important for deciding whether a treatment is effective. The main purpose of this observational study is therefore to develop Core Outcome Domain Sets for the three different intervention strategies (sound, psychological, and pharmacological) for adults with chronic subjective tinnitus that should be measured and reported in every clinical trial of these interventions. Secondary objectives are to identify the strengths and limitations of our study design for recruiting and reducing attrition of participants, and to explore uptake of the core outcomes. Methods: The ‘Core Outcome Measures in Tinnitus: International Delphi’ (COMIT’ID) study will use a mixed methods approach that incorporates input from healthcare users at the pre-Delphi stage, a modified three round Delphi survey and final consensus meetings (one for each intervention). The meetings will generate recommendations by stakeholder representatives on agreed Core Outcome Domain Sets specific to each intervention. A subsequent step will establish a common cross-cutting Core Outcome Domain Set by identifying the common outcome domains included in all three intervention-specific Core Outcome Domain Sets. To address the secondary objectives, we will gather feedback from participants about their experience of taking part in the Delphi process. We aspire to conduct an observational cohort study to evaluate uptake of the core outcomes in published studies at 7 years following core outcome set publication. Discussion: The COMIT’ID study aims to develop a Core Outcome Domain Set that are agreed as critically important fo

Background: The reporting of outcomes in clinical trials of subjective tinnitus indicates that many different tinnitus-related complaints are of interest to investigators, from perceptual attributes of the sound (e.g. loudness) to psychosocial impacts (e.g. quality of life). Even when considering one type of intervention strategy for subjective tinnitus, there is no agreement about what is critically important for deciding whether a treatment is effective. The main purpose of this observational study is therefore to develop Core Outcome Domain Sets for the three different intervention strategies (sound, psychological, and pharmacological) for adults with chronic subjective tinnitus that should be measured and reported in every clinical trial of these interventions. Secondary objectives are to identify the strengths and limitations of our study design for recruiting and reducing attrition of participants, and to explore uptake of the core outcomes. Methods: The ‘Core Outcome Measures in Tinnitus: International Delphi’ (COMIT’ID) study will use a mixed methods approach that incorporates input from healthcare users at the pre-Delphi stage, a modified three round Delphi survey and final consensus meetings (one for each intervention). The meetings will generate recommendations by stakeholder representatives on agreed Core Outcome Domain Sets specific to each intervention. A subsequent step will establish a common cross-cutting Core Outcome Domain Set by identifying the common outcome domains included in all three intervention-specific Core Outcome Domain Sets. To address the secondary objectives, we will gather feedback from participants about their experience of taking part in the Delphi process. We aspire to conduct an observational cohort study to evaluate uptake of the core outcomes in published studies at 7 years following core outcome set publication. Discussion: The COMIT’ID study aims to develop a Core Outcome Domain Set that are agreed as critically important fo