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Background There is strong evidence that collaborative practice in mental healthcare improves outcomes for patients. The concept of collaborative practice can include collaboration between healthcare workers of different professional backgrounds and collaboration with patients, families and communities. Most models of collaborative practice were developed in Western and high-income countries and are not easily translatable to settings which are culturally diverse and lower in resources. This project aimed to develop a set of recommendations to improve collaborative practice in Malaysia. Methods In the first phase, qualitative research was conducted to better understand collaboration in a psychiatric hospital (previously published). In the second phase a local hospital level committee from the same hospital was created to act on the qualitative research and create a set of recommendations to improve collaborative practice at the hospital for the hospital. Some of these recommendations were implemented, where feasible and the outcomes discussed. These recommendations were then sent to a nationwide Delphi panel. These committees consisted of healthcare staff of various professions, patients and carers. Results The Delphi panel reached consensus after three rounds. The recommendations include ways to improve collaborative problem solving and decision making in the hospital, ways to improve the autonomy and relatedness of patients, carers and staff and ways to improve the levels of resources (e.g. skills training in staff, allowing people with lived experience of mental disorder to contribute). Conclusions This study showed that the Delphi method is a feasible method of developing recommendations and guidelines in Malaysia and allowed a wider range of stakeholders to contribute than traditional methods of developing guidelines and recommendations. Trial registration Registered in the National Medical Research Register, Malaysia, NMRR-13-308-14792

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.

Supplemental Digital Content is available in the text, Background: Obstructive sleep apnea hypopnea syndrome (OSAHS) is a common, chronic sleep disease. As the incidence of OSAHS increases, it has seriously threatened people's health. There have been an increasing number of clinical trials of OSAHS in recent years. However, the clinical trials of OSAHS have heterogeneous outcomes, surrogate outcomes, subjective outcomes, and composite outcomes, as well as the lack of endpoints or patient perspectives. The best method is to develop a core outcomes sets (COSs) for OSAHS's clinical trials. Methods: The development of COSs of OSAHS will include 5 stages: (1) set up a Steering Group, defining the scope of this COSs; (2) identifying potential core outcomes by systematic review and semi-structured interviews; (3) identifying final COSs by consensus process, includes Delphi survey and face-to-face meeting; (4) identification and evaluation of instruments used to measure the final COSs; (5) promotion and updates. Results: The results of our study will be published in a peer-reviewed journal. Discussion: The development of the COSs of OSAHS will improve the design and operation of OSAHS clinical trials to conform to international standards and ensure the credibility of the outcomes. In addition, this study will involve different stakeholder groups to help ensure that the developed COSs will be suitable and well accepted. Trial registration number: 1544.

Background In hospital cancer care, there is no set standard for next-of-kin involvement in improving the quality of care and patient safety. There is therefore a growing need for tools and methods that can guide this complex area. Objective The aim of this study was to present the results from a consensus-based participatory process of designing a guide for next-of-kin involvement in hospital cancer care. Method A consensus process based on a modified Nominal group technique was applied with 20 stakeholder participants from 2 Norwegian university hospitals. Result The participants agreed on the 5 most important priorities for hospital cancer care services when involving next-of-kin. The results showed that next-of-kin stakeholders, when proactively involved, are important resources for the patient and healthcare professionals in terms of contribution to quality and safety in hospitals. Suggested means of involving next-of-kin were closer interaction with external support bodies, integration in clinical pathways, adjusted information, and training healthcare professionals. Conclusion In this study, we identified topics and elements to include in a next-of-kin involvement guide to support quality and safety in hospital cancer care. The study raises awareness of the complex area of next-of-kin involvement and contributes with theory development and knowledge translation in an involvement guide tailored for use by healthcare professionals and managers in everyday clinical practice. Implications for Practice Service providers can use the guide to formulate intentions and make decisions with suggestions and priorities or as a reflexive tool for organizational improvement.

Background Single-sided deafness (SSD) describes the presence of a unilateral severe to profound sensorineural hearing loss. SSD disrupts spatial hearing and understanding speech in background noise. It has functional, psychological and social consequences. Potential options for rehabilitation include hearing aids and auditory implants. Benefits and harms of these interventions are documented inconsistently in the literature, using a variety of outcomes ranging from tests of speech perception to quality of life questionnaires. It is therefore difficult to compare interventions when rehabilitating SSD. The Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study is an international initiative that aims to develop a minimum set of core outcomes for use in future trials of SSD interventions. Methods/design The CROSSSD study adopts an international two-round online modified Delphi survey followed by a stakeholder consensus meeting to identify a patient-centred core outcome domain set for SSD based on what is considered critical and important for assessing whether an intervention for SSD has worked. Discussion The resulting core outcome domain set will act as a minimum standard for reporting in future clinical trials and could have further applications in guiding the use of outcome measures in clinical practice. Standardisation will facilitate comparison of research findings.

Background Developing a shared agenda is an important step in ensuring future research has the necessary relevance. Objective To characterise research priority setting partnerships (PSPs) relevant to women's health. Search strategy Included studies were identified by searching MEDLINE and the James Lind Alliance (JLA) database. Selection criteria Priority setting partnerships using formal consensus methods. Data collection and analysis Descriptive narrative to describe the study characteristics, methods, and results. Main results Ten national and two international PSPs were identified. All PSPs used the JLA method to identify research priorities. Nine PSPs had published a protocol. Potential research uncertainties were gathered from guidelines (two studies), Cochrane reviews (five studies), and surveys (12 studies). The number of healthcare professionals (31-287), patients (44-932), and others (33-139) who responded to the survey, and the number of uncertainties submitted (52-4767) varied. All PSPs entered confirmed research uncertainties (39-104) into interim priority setting surveys and healthcare professionals (31-287), patients (44-932), and others (33-139) responded. All PSPs entered a short list of research uncertainties into a consensus development meeting, which enabled healthcare professionals (six to 21), patients (eight to 14), and others (two to 13) to identify research priorities (ten to 15). Four PSPs have published their results. Conclusion Future research priority setting studies should publish a protocol, use formal consensus development methods, and ensure their methods and results are comprehensively reported. Tweetable abstract Research published in @BJOGtweets highlights future research priorities across women's health, including @FertilityTop10, @jamesmnduffy.

Background Single-sided deafness (SSD) describes the presence of a unilateral severe to profound sensorineural hearing loss. SSD disrupts spatial hearing and understanding speech in background noise. It has functional, psychological and social consequences. Potential options for rehabilitation include hearing aids and auditory implants. Benefits and harms of these interventions are documented inconsistently in the literature, using a variety of outcomes ranging from tests of speech perception to quality of life questionnaires. It is therefore difficult to compare interventions when rehabilitating SSD. The Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study is an international initiative that aims to develop a minimum set of core outcomes for use in future trials of SSD interventions. Methods/design The CROSSSD study adopts an international two-round online modified Delphi survey followed by a stakeholder consensus meeting to identify a patient-centred core outcome domain set for SSD based on what is considered critical and important for assessing whether an intervention for SSD has worked. Discussion The resulting core outcome domain set will act as a minimum standard for reporting in future clinical trials and could have further applications in guiding the use of outcome measures in clinical practice. Standardisation will facilitate comparison of research findings.

Medial humeral epicondyle fractures of the elbow are one of the most common injuries in childhood and often require surgery. There are currently no standardised outcome measures to assess progress after an elbow injury in a child. Wide variation in currently reported outcomes makes comparison of treatment difficult. This study aims to identify outcome measures that have previously been reported in studies evaluating the management of medial epicondyle fractures in children and to facilitate the development of a consensus core outcome set (COS) suitable for use in all future studies of medial humeral epicondyle fractures in children. This study will include a systematic review of the academic literature to identify a list of outcome measures that have previously been reported. The list of outcome measures will be used in a consensus setting exercise with focus groups of key stakeholders to identify key outcomes. A Delphi process to include two rounds will then be used to define the most important outcomes to all stakeholders forming the COS. Core outcomes represent the minimum expected data reported for a specific condition and will improve the quality of future studies reducing bias, allowing easier comparison and enhancing opportunities for larger meta-analysis. It is anticipated that this COS will form part of the feasibility to a National Institute for Health Research (NIHR) Health Technology Assessment (HTA)-funded trial concerning the management of elbow fractures in children. Core Outcome Measures in Effectiveness Trials Initiative (COMET), registration number: 949 . Registered on 17 January 2017. Prospero International prospective register of systematic reviews, registration number: CRD 42017057912 . Registered on 16 April 2017.

Background Current ambulance quality and performance measures, such as response times, do not reflect the wider scope of care that services now provide. Using a three‐stage consensus process, we aimed to identify new ways of measuring ambulance service quality and performance that represent service provider and public perspectives. Design A multistakeholder consensus event, modified Delphi study, and patient and public consensus workshop. Setting and participants Representatives from ambulance services, patient and public involvement (PPI) groups, emergency care clinical academics, commissioners and policymakers. Results Nine measures/principles were highly prioritized by >75% of consensus event participants, including measures relating to pain, patient experience, accuracy of dispatch decisions and patient safety. Twenty experts participated in two Delphi rounds to further refine and prioritize measures; 20 measures in three domains scored ≥8/9, indicating good consensus, including proportion of calls correctly prioritized, time to definitive care and measures related to pain. Eighteen patient/public representatives attended a consensus workshop, and six measures were identified as important. These include time to definitive care, response time, reduction in pain scores, calls correctly prioritized to appropriate levels of response and survival to hospital discharge for treatable emergency conditions. Conclusions Using consensus methods, we identified a shortlist of ambulance outcome and performance measures that are important to ambulance clinicians and service providers, service users, commissioners, and clinical academics, reflecting current pre‐hospital ambulance care and services. The measures can potentially be used to assess pre‐hospital quality or performance over time, with most calculated using routinely available data.

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.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.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.'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.Skupno število raziskav na področju znanosti o uvajanju izboljšav vzdravstvu (Healthcare Improvement Science - HIS) je majhno. Vendar pa bi morala izboljševanje kakovosti in vpeljava sprememb postati neločljivo povezana z vsakodnevnim delom zdravstvenih delavcev na vseh področjih zdravstvenega sistema. Pomanjkanje teoreticnih izhodišč bi lahko delno pojasnilo nizko stopnjo prenosa rezultatov raziskav v zdravstveno politiko.Namen članka je predstaviti postopek oblikovanja definicije za pojem znanost o uvajanju izboljšav v zdravstvu. Pri pristopu z metodami konsenza smo uporabili metodo Delfi, izvedeno v dveh krogih, panelne skupine strokovnjakov in tehnike konsenzne skupine. V skupini strokovnjakov in konsenzni skupini je sodelovalo 18 oseb, v okviru metode Delfi smo analizirali 153 odgovorov. Sodelujoče osebe so bile raziskovalci, izobraževalci in zdravstveni delavci iz Škotske, Slovenije, Španije, Italije, Anglije, Poljske in Romunije.V drugem krogu metode Delfi je bila dosežena visoka stopnja konsenza (86-odstotna) za široko definicijo. Konsenzna skupina je oblikovala naslednjo končno definicijo: »Znanost o uvajanju izboljšav omogoca ustvarjanje znanj za izvajanje sprememb ter zagotavljanje v pacienta usmerjene zdravstvene obravnave, ki je varna, zmogljiva, učinkovita, pravična in pravočasna. Izboljšuje pacientove izide zdravstvene obravnave, sistem nudenja zdravstvenih storitev in zdravje populacije.«.Postopek oblikovanja dogovorne definicije je razkril različno razumevanje pojma znanost o uvajanju izboljšav v zdravstvu med sodelujočimi. Oblikovanje skupne dogovorne definicije je pomemben korak naprej, saj pripomore k splošnemu razumevanju tega pojma in s tem tudi k spodbujanju strokovnega izobraževanja in izvajanju znanosti o uvajanju izboljšav v praksi.

IntroductionPrimary school-based physical activity interventions, such as The Daily Mile initiative, have the potential to increase children’s physical activity levels over time, which is associated with a variety of health benefits. Comparing interventions or combining results of several studies of a single intervention is challenging because previous studies have examined different outcomes or used different measures that are not feasible or relevant for researchers in school settings. The development and implementation of a core outcome set (COS) for primary school-based physical activity interventions would ensure outcomes important to those involved in implementing and evaluating interventions are standardised.Methods and analysisOur aim is to develop a COS for studies of school-based physical activity interventions. We will achieve this by undertaking a four-stage process:(1) identify a list of outcomes assessed in studies through a systematic review of international literature; (2) establish domains from these outcomes to produce questionnaire items; (3) prioritise outcomes through a two-stage Delphi survey with four key stakeholder groups (researchers, public health professionals, educators and parents), where stakeholders rate the importance of each outcome on a 9-point Likert scale (consensus that the outcomes should be included in the COS will be determined as 70% or more of all stakeholders scoring the outcome 7%–9% and 15% or less scoring 1 to 3); (4) achieve consensus on a final COS in face-to-face meetings with a sample of stakeholders and primary school children.Ethics and disseminationWe have received ethical approval from Imperial College London (ref: 19IC5428). The results of this study will be disseminated via conference presentations/public health meetings, peer-reviewed publications and through appropriate media channels.Trial registration numberCore Outcome Measures in Effectiveness Trials Initiative (COMET) number: 1322.

BackgroundSome interventions are developed from practice, and implemented before evidence of effect is determined, or the intervention is fully specified. An example is Namaste Care, a multi-component intervention for people with advanced dementia, delivered in care home, community, hospital and hospice settings. This paper describes the development of an intervention description, guide and training package to support implementation of Namaste Care within the context of a feasibility trial. This allows fidelity to be determined within the trial, and for intervention users to understand how similar their implementation is to that which was studied.MethodsA four-stage approach: a) Collating existing intervention materials and drawing from programme theory developed from a realist review to draft an intervention description. b) Exploring readability, comprehensibility and utility with staff who had not experienced Namaste Care. c) Using modified nominal group techniques with those with Namaste Care experience to refine and prioritise the intervention implementation materials. d) Final refinement with a patient and public involvement panel.ResultsEighteen nursing care home staff, one carer, one volunteer and five members of our public involvement panel were involved across the study steps. A 16-page A4 booklet was designed, with flow charts, graphics and colour coded information to ease navigation through the document. This was supplemented by infographics, and a training package. The guide describes the boundaries of the intervention and how to implement it, whilst retaining the flexible spirit of the Namaste Care intervention.ConclusionsThere is little attention paid to how best to specify complex interventions that have already been organically implemented in practice. This four-stage process may have utility for context specific adaptation or description of existing, but untested, interventions. A robust, agreed, intervention and implementation description should enable a high-quality future trial. If an effect is determined, flexible practice implementation should be enabled through having a clear, evidence-based guide.

INTRODUCTION: Systemic sclerosis (SSc) is a chronic autoimmune disease with multiorgan involvement. OBJECTIVE: Identify preferences and priorities among patients and health care professionals regarding care for SSc patients in The Netherlands. Develop ideas to improve quality of care. METHODS: A structured approach was followed to collect information from different perspectives to prepare a working conference. Qualitative and quantitative data from patients (n = 650), rheumatologists (n = 167), nurses (n = 51), and health professionals (n = 85) from regional centers and university hospitals were collected. In February 2018, a working conference was organized. Seventy-seven persons (including 10 SSc patients) from different backgrounds discussed the identified themes and survey results. Ideas to improve health care were formulated and prioritized using nominal group technique. RESULTS: Five key themes were identified: (1) shared care and multidisciplinary collaboration, (2) medical data exchange, (3) information for both patients and health care professionals, (4) patient empowerment, and (5) non-pharmacological care. Shared care was the preferred model of care in 49% of patients and 82% of physicians. However, current collaboration structures, especially between hospitals, should be improved. Suggestions for improvements were explicitly formulated agreements about referral, clear task division, treatment coordination, and exploration of novel ways to exchange medical records. The creation of a national web-based information hub was highly prioritized. CONCLUSION: In this mixed-method study, broad-based consensus was achieved and recommendations were developed to improve health care for SSc patients. The approach, recommendations, and challenges summarized in this paper can be of use for health care professionals and other actors involved in patients with rare, chronic, and multisystem conditions.

Background Polypharmacy is an increasing challenge for primary care. Although sometimes clinically justified, polypharmacy can be inappropriate, leading to undesirable outcomes. Optimising care for polypharmacy necessitates effective targeting and monitoring of interventions. This requires a valid, reliable measure of polypharmacy, relevant for all patients, that considers clinical appropriateness and generic prescribing issues applicable across all medications. Whilst there are several existing measures of potentially inappropriate prescribing, these are not specifically designed with polypharmacy in mind, can require extensive clinical input to complete, and often cover a limited number of drugs. The aim of this study was to identify what experts consider to be the key elements of a measure of prescribing appropriateness in the context of polypharmacy. Methods Firstly, we conducted a systematic review to identify generic (not drug specific) prescribing indicators relevant to polypharmacy appropriateness. Indicators were subject to content analysis to enable categorisation. Secondly, we convened a panel of 10 clinical experts to review the identified indicators and assess their relative clinical importance. For each indicator category, a brief evidence summary was developed, based on relevant clinical and indicator literature, clinical guidance, and opinions obtained from a separate patient discussion panel. A two-stage RAND/UCLA Appropriateness Method was used to reach consensus amongst the panel on a core set of indicators of polypharmacy appropriateness. Results We identified 20,879 papers for title/abstract screening, obtaining 273 full papers. We extracted 189 generic indicators, and presented 160 to the panel grouped into 18 classifications (e.g. adherence, dosage, clinical efficacy). After two stages, during which the panel introduced 18 additional indicators, there was consensus that 134 indicators were of clinical importance. Following the application of decision rules and further panel consultation, 12 indicators were placed into the final selection. Panel members particularly valued indicators concerned with adverse drug reactions, contraindications, drug-drug interactions, and the conduct of medication reviews. Conclusions We have identified a set of 12 indicators of clinical importance considered relevant to polypharmacy appropriateness. Use of these indicators in clinical practice and informatics systems is dependent on their operationalisation and their utility (e.g. risk stratification, targeting and monitoring polypharmacy interventions) requires subsequent evaluation. Trial registration Registration number: PROSPERO (CRD42016049176). Electronic supplementary material The online version of this article (10.1186/s12916-018-1078-7) contains supplementary material, which is available to authorized users.

ObjectiveTo 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).MethodsThis 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.ResultsThe 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.ConclusionThese 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 There are few areas of health care where sufficient research-based evidence exists and primary health care is no exception. In the absence of such evidence, the development of assisted support must be based on the opinions and experience of professionals with knowledge of the relevant field. The purpose of this research project is to explore how the nominal group technique can be used to establish consensus by analysing how it supported the development of structured, knowledge-based, electronic health records for preventive child health examinations in Danish general practice. Methods We convened an expert panel of five general practitioners with a special interest in the preventive child health examinations. We introduced the panel to the nominal group technique, a well-established, structured, multistep, facilitated, group meeting technique used to generate consensus. The panel used the technique to agree on the key clinical and socioeconomic themes to include in new electronic records for the seven preventive child health examinations in Denmark. The panel met three times over a four-month period between 2013 and 2014 and their meetings lasted between two-and-a-half and five hours. Results 1) The structured and stepwise process of the nominal group technique supported our expert panel’s focus as well as their equal opportunities to speak. 2) The method’s flexibility enabled participants to work as a group and in pairs to discuss and refine thematic classifications. 3) Serial meetings supported continual evaluation, critical reflection, and knowledge searches, enabling our panel to produce a template that could be adapted for all seven preventive child health examinations. Conclusion The nominal group technique proved to be a useful method for reaching consensus by identifying key quality markers for use in daily clinical practice. Our study focused on the development of content and a layout for systematic, knowledge-based, electronic health records. We recommend the method as a suitable working tool for dealing with complex questions in general practice or similar settings, and we present and discuss modifications to the original model.

Due to changes in social and health needs, the reorganisation of health systems towards community and primary care requires the redefinition of different professional identities and practices. This paper focuses on the specialists in the system: the physicians who work in outpatient services (local health authorities, hospitals, and other institutions) not as dependents but under private contract. This doctor has to balance the professional culture (in terms of autonomy and indipendence of judgment) with the bureaucratic logic that rules the organisations for which he or she works. Our research objective was to identify the identity variables characterising the specialist doctor ("ideal profile") and analyse the extent to which these differed from the doctor's actual identity ("actual profile"). From a methodological perspective, 1) we used a consensus method approach to identify the variables that define the specialist's identity, and 2) using a national web survey, we checked the distance between such characteristics and these professionals' actual identities. Involving different experts in the field of primary care, we identified 27 identity variables that appear to be at the core of specialist expertise. We then asked a representative sample of specialists to indicate how important and feasible these variables were in their work contexts and identified four main factors characterising their identities. The results demonstrate that, among experts, there is a clear perception of the need to build an identity that is linked to integration and to adopt a heuristic approach through teamwork and networking. However, this differs considerably from the logic of the specialists working in outpatient services: What emerges is the perceived difficulty of operational translation due to organisational problems or, otherwise, the constitutive elements of professional identity.

International audience; 1. Biological invasions are a threat to biodiversity, society and the economy. There is an urgent need to provide evidence- based assessments of the risks posed by invasive alien species (IAS) to prioritize action. Risk assessments underpin IAS policies in many ways: informing legislation; providing justification of restrictions in trade or consumer activities; prioritizing surveillance and rapid response. There are benefits to ensuring consistency in content of IAS risk assessments globally, and this can be achieved by providing a framework of minimum standards as a checklist for quality assurance. 2. From a review of existing risk assessment protocols, and with reference to the requirements of the EU Regulation on IAS (1143/2014) and international agreements including the World Trade Organisation, Convention on Biological Diversity and International Plant Protection Convention, coupled with consensus methods, we identified and agreed upon 14 minimum standards (attributes) a riskassessment scheme should include. 3. The agreed minimum standards were as follows: (1) basic species description; (2) likelihood of invasion; (3) distribution, spread and impacts; (4) assessment of introduction pathways; (5) assessment of impacts on biodiversity and ecosystems; (6) Assessment of impact on ecosystem services; (7) assessment of socio-economic impacts; (8) consideration of status (threatened or protected) of species or habitat under threat; (9) assessment of effects of future climate change; (10) completion possible even when there is a lack of information; (11) documents information sources; (12) provides a summary in a consistent and interpretable form; (13) -includes uncertainty; (14) includes quality assurance. In deriving these minimum standards, gaps in knowledge required for completing risk assessments and the scope of existing risk assessment protocols were revealed, most notably in relation to assessing benefits, socio-economic impacts and impacts on ecosystem services but also inclusion of consideration of climate change. 4. Policy implications. We provide a checklist of components that should be within invasive alien species risk assessments and recommendations to develop risk assessments to meet these proposed minimum standards. Although inspired by implementation of the European Union Regulation on invasive alien species, and as such developed specifically within a European context, the derived framework and minimum standards could be applied globally.

BACKGROUND: The evidence base to assess the efficacy and effectiveness of alcohol brief interventions (ABI) is weakened by variation in the outcomes measured and by inconsistent reporting. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) project aims to develop a core outcome set (COS) and reporting guidance for its use in future trials of ABI in a range of settings.METHODS/DESIGN: An international Special Interest Group was convened through INEBRIA (International Network on Brief Interventions for Alcohol and Other Drugs) to inform the development of a COS for trials of ABI. ORBITAL will incorporate a systematic review to map outcomes used in efficacy and effectiveness trials of ABI and their measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. This will support a multi-round Delphi study to prioritise outcomes. Delphi panellists will be drawn from a range of settings and stakeholder groups, and the Delphi study will also be used to determine if a single COS is relevant for all settings. A consensus meeting with key stakeholder representation will determine the final COS and associated guidance for its use in trials of ABI.DISCUSSION: ORBITAL will develop a COS for alcohol screening and brief intervention trials, with outcomes stratified into domains and guidance on outcome measurement instruments. The standardisation of ABI outcomes and their measurement will support the ongoing development of ABI studies and a systematic synthesis of emerging research findings. We will track the extent to which the COS delivers on this promise through an exploration of the use of the guidance in the decade following COS publication.

Introduction Crohn’s disease (CD) and ulcerative colitis (UC), the main forms of inflammatory bowel disease (IBD), are chronic, progressive and disabling disorders of the gastrointestinal tract. Although data from randomised controlled trials (RCTs) provide the foundation of evidence that validates medical therapy for IBD, considerable heterogeneity exists in the measured outcomes used in these studies. Furthermore, in recent years, there has been a paradigm shift in IBD treatment targets, moving from symptom-based scoring to improvement or normalisation of objective measures of inflammation such as endoscopic appearance, inflammatory biomarkers and histological and radiographic end points. The abundance of new treatment options and evolving end points poses opportunities and challenges for all stakeholders involved in drug development. Accordingly, there exists a need to harmonise measures used in clinical trials through the development of a core outcome set (COS). Methods and analysis The development of an IBD-specific COS includes four steps. First, a systematic literature review is performed to identify outcomes previously used in IBD RCTs. Second, semistructured qualitative interviews are conducted with key stakeholders, including patients, clinicians, researchers, pharmaceutical industry representatives, healthcare payers and regulators to identify additional outcomes of importance. Using the outcomes generated from literature review and stakeholder interviews, an international two-round Delphi survey is conducted to prioritise outcomes for inclusion in the COS. Finally, a consensus meeting is held to ratify the COS and disseminate findings for application in future IBD trials. Ethics and dissemination Given that over 30 novel therapeutic compounds are in development for IBD treatment, the design of robust clinical trials measuring relevant and standardised outcomes is crucial. Standardising outcomes through a COS will reduce heterogeneity in trial reporting, facilitate valid comparisons of new therapies and improve clinical trial quality.

Background Patients with moderate-to-severe atopic eczema (AE) often require photo- or systemic immunomodulatory therapies to induce disease remission and maintain long-term control. The current evidence to guide clinical management is small, despite the frequent and often off-label use of these treatments. Registries of patients on photo- and systemic immunomodulatory therapies could fill this gap, and the collection of a core set concerning these therapies in AE will allow direct comparisons across registries as well as data sharing and pooling. Using an eDelphi approach, the international TREatment of ATopic eczema (TREAT) Registry Taskforce aims to seek consensus between key stakeholders internationally on a core set of domains and domain items for AE patient registries with a research focus that collect data of children and adults on photo- and systemic immunomodulatory therapies. Methods/design Participants from six stakeholder groups will be invited: doctors, nurses, non-clinical researchers, patients, as well as industry and regulatory body representatives. The eDelphi will comprise three sequential online rounds, requesting participants to rate the importance of each proposed domain and domain items. Participants will be able to add domains and domain items to the proposed list in round 1. A final consensus meeting will be held with representatives of each stakeholder group. Discussion Identifying a uniform core set of domains and domain items to be captured by AE patient registries will increase the utility of individual registries, and provide greater insight into the effectiveness, safety and cost-effectiveness of photo- and systemic immunomodulatory therapies to guide clinical management across dermatology centres and country borders. Trial registration Not applicable. This eDelphi study was registered in the Core Outcome Measures for Effectiveness Trials (COMET) database. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1765-7) contains supplementary material, which is available to authorized users.

Background: Empirical knowledge around palliative care provision and needs of people with intellectual disabilities is extremely limited, as is the availability of research resources, including expertise and funding. This paper describes a consultation process that sought to develop an agenda for research priorities for palliative care of people with intellectual disabilities in Europe. Methods: A two-day workshop was convened, attended by 16 academics and clinicians in the field of palliative care and intellectual disability from six European countries. The first day consisted of round-table presentations and discussions about the current state of the art, research challenges and knowledge gaps. The second day was focused on developing consensus research priorities with 12 of the workshop participants using nominal group technique, a structured method which involved generating a list of research priorities and ranking them in order of importance. Results: A total of 40 research priorities were proposed and collapsed into eleven research themes. The four most important research themes were: investigating issues around end of life decision making; mapping the scale and scope of the issue; investigating the quality of palliative care for people with intellectual disabilities, including the challenges in achieving best practice; and developing outcome measures and instruments for palliative care of people with intellectual disabilities. Conclusions: The proposal of four major priority areas and a range of minor themes for future research in intellectual disability, death, dying and palliative care will help researchers to focus limited resources and research expertise on areas where it is most needed and support the building of collaborations. The next steps are to cross-validate these research priorities with people with intellectual disabilities, carers, clinicians, researchers and other stakeholders across Europe; to validate them with local and national policy makers to determine how they could best be incorporated in policy and programmes; and to translate them into actual research studies by setting up European collaborations for specific studies that require such collaboration, develop research proposals and attract research funding., BMC Palliative Care, 15, ISSN:1472-684X

Background Over the last four decades, the health status of Maldivian people improved considerably, as reflected in child and maternal mortality indicators and the eradication or control of many communicable diseases. However, changing disease patterns are now undermining these successes, so the local public health practitioners need new skills to perform effectively in this changing environment. To address these needs, in 2013 the Faculty of Health Sciences of the Maldives National University developed the country’s first Master of Public Health (MPH) program. Methods The process commenced with a wide scoping exercise and an analysis of the curricular structure of MPH programs of high-ranking universities. Thereafter, a stakeholder consultation using consensus methods reached agreement on overall course structure and the competencies required for local MPH graduates. Subsequently, a working group developed course descriptors and identified local public health research priorities, which could be addressed by MPH students. Results Ten semistructured interviews explored specific training needs of prospective MPH students, key public health competencies required by local employers and preferred MPH training models. The recommendations informed a nominal group meeting, where participants agreed on MPH core competencies, overall curricular structure and core subjects. The 17 public health electives put forward by the group were prioritized using an online Delphi process. Participants ranked them by their propensity to address local public health needs and the locally available teaching expertise. The first student cohort commenced their MPH studies in January 2014. Conclusion Consensus methods allowed a broad stakeholder engagement with public health curriculum development and the creation of a country-specific curriculum, informed by local realities and needs., Video abstract

Background Prostate cancer is a growing health problem worldwide. The management of localised prostate cancer is controversial. It is unclear which of several surgical, radiotherapeutic, ablative, and surveillance treatments is the most effective. All have cost, process and recovery, and morbidity implications which add to treatment decision-making complexity for patients and healthcare professionals. Evidence from randomised controlled trials (RCTs) is not optimal because of uncertainty as to what constitutes important outcomes. Another issue hampering evidence synthesis is heterogeneity of outcome definition, measurement, and reporting. This project aims to determine which outcomes are the most important to patients and healthcare professionals, and use these findings to recommend a standardised core outcome set for comparative effectiveness trials of treatments for localised prostate cancer, to optimise decision-making. Methods/Design The range of potentially important outcomes and measures will be identified through systematic reviews of the literature and semi-structured interviews with patients. A consultation exercise involving representatives from two key stakeholder groups (patients and healthcare professionals) will ratify the list of outcomes to be entered into a three round Delphi study. The Delphi process will refine and prioritise the list of identified outcomes. A methodological substudy (nested RCT design) will also be undertaken. Participants will be randomised after round one of the Delphi study to one of three feedback groups, based on different feedback strategies, in order to explore the potential impact of feedback strategies on participant responses. This may assist the design of a future core outcome set and Delphi studies. Following the Delphi study, a final consensus meeting attended by representatives from both stakeholder groups will determine the final recommended core outcome set. Discussion This study will inform clinical practice and future trials of interventions of localised prostate cancer by standardising a core outcome set which should be considered in comparative effectiveness studies for localised prostate cancer. Electronic supplementary material The online version of this article (doi:10.1186/s13063-015-0598-0) contains supplementary material, which is available to authorized users.

Definitions are social constructions rather than objective descriptions. They set clear boundaries for what is considered normal in a situation. Common words in organizations, like effectiveness or success, carry different meaningss in different contexts. In this paper, we evaluate the Delphi Technique as a method for explicating context-specific definitions and illustrate its use in formulating a context-specific definition of ‘an effective health care team’. Eight multi-disciplinary organization members participated in the study and reached consensus on characteristics assigned to team effectiveness in three rounds. The final definition implies the influence of organizational values, underscoring the importance of context specificity in organization studies.

In this paper we consider distributed localization in a wireless peer-to-peer network. Each node is required to estimate the geographical configuration of the whole network (i.e., the positions of all nodes regardless of link availability) based on local processing and iterated information exchange with neighbors. We propose a new weighted-average consensus method based on received-signal-strength peer-to-peer measurements. To handle the non-linearity of the measurement model, an iterative Gauss-Newton location estimator is integrated into the consensus algorithm. Consensus processing is designed so as to account for the different degree of reliability of the location information provided by different neighbors and boost the convergence process. Performances are analysed and compared to those of conventional consensus algorithms, in terms of accuracy and convergence rate, using fundamental performance bounds as benchmarks.

Aims: To describe an adapted Nominal Group Technique which can be applied to mixed populations. Study Design: Mixed methods Nominal Group Technique (NGT) consensus building exercise. Place and Duration of Study: Community Pharmacy across South West Wales, United Kingdom (UK) between 2009 and 2010. Methodology: We describe the research methodology involved in an adapted Nominal Group Technique. We carried out the adapted NGT exercise in homogenous consultation workshops following the traditional approach which resulted in the generation of individual consensus lists of the important issues related to the posed question. In order to ensure that issues highlighted within different consultation workshops were maintained in the outputs we further developed the NGT approach, firstly by bringing common issues together by applying a thematization process and then further applying a second consensus building exercise based on the developed themes with a mixed population group. By supplementing consensus data with qualitative data collected during the research process, we further explored and justified the consensus reached. Results: We successfully applied the adapted NGT within the community pharmacy setting and were able to gain consensus regarding the positive and challenging aspects of patient- centred professionalism. Using qualitative data collected, we were able to describe in more detail the issues raised and the justification for the consensus reached. Conclusion: Using an adapted NGT, we describe how consensus was reached regarding the study question and how the basis for the consensus was explored. By applying this adapted NGT we were able to gain consensus regarding the relative importance of the issues under discussion across a mixed population group. The adapted approach allowed us to elaborate upon the consensus reached and justify the relative importance of the choices that were made.

Contains fulltext : 172046.pdf (Publisher’s version ) (Open Access) BACKGROUND: Entrustable Professional Activities (EPAs) are increasingly used as a focus for assessment in graduate medical education (GME). However, a consistent approach to guide EPA design is currently lacking, in particular concerning the actual content (knowledge, skills and attitude required for specific tasks) for EPAs. This paper describes a comprehensive five stage approach, which was used to develop two specialty-specific EPAs in emergency medicine focused on the first year of GME. METHODS: The five stage approach was used to gain consensus on the task, content and entrustment scale for two specialty-specific EPAs in emergency medicine. The participants consisted of twelve clinical supervisors working in the emergency department. The five stages were: 1) Selecting the EPA topic; 2) Developing the EPA content by collecting data from participants using focus group and individual interviews; 3) Drafting the EPAs based on analysis of collected data; 4) Seeking feedback on the draft EPAs from the participants and other stakeholders; 5) Refining and finalising the EPAs based on feedback. RESULTS: Two specialty-specific EPAs were developed using the five stage approach. The participants reached consensus on the specific tasks and criteria for performance for the two EPAs. They also agreed that both day-to-day (ad hoc) and formal (summative) entrustment decisions were put into practice through the intensity of supervision provided to PGY1 doctors. As a result, a three level entrustment and supervision scale consisting of direct active, indirect active, passive was developed reflecting the shift in the intensity of supervision from close supervision to minimal supervision. CONCLUSIONS: The five stage approach described in this paper was used successfully to develop two specialty-specific EPAs in emergency medicine along with a three level entrustment scale.We propose that the five stage approach is transferable to a range of medical training contexts to design specialty-specific EPAs.

Background Cleft palate (CP) has an incidence of approximately 1 in 700. Children with CP are also susceptible to otitis media with effusion (OME), with approximately 90% experiencing nontrivial OME. There are several approaches to the management of OME in children with CP. The Management of Otitis Media with Effusion in Children with Cleft Palate (MOMENT) study is a feasibility study that includes the development of a core outcome set for use in future trials of the management of OME in children with CP. Methods/Design The MOMENT study will include a systematic review of the literature to identify a list of outcomes that have previously been reported. This list of outcomes will be used in a Delphi study with cleft clinicians. The Delphi study is anticipated to include three rounds. The first round will ask clinicians to score the outcome list and to add any outcomes they think are relevant. The second round involves presentation of scores according to stakeholder group and the opportunity for participants to rescore outcomes. To ensure that the opinion of parents and children are sought, qualitative interviews will be completed with a purposive sample in parallel. In the final round of the Delphi process, participants will be shown the distribution of scores, for each outcome, for all stakeholder groups separately as well as a summary of the results concerning outcomes from the qualitative interviews with parents. A final consensus meeting will be held with all stakeholders, including parents and children, to review outcomes. Discussion A core outcome set represents the minimum that should be measured in a clinical trial for a particular condition. The MOMENT study will aim to identify a core outcome set that can be used in future trials of the management of OME, improving the consistency of research in this clinical area.

Introduction Current instruments to evaluate the postgraduate medical educational environment lack theoretical frameworks and are relatively long, which may reduce response rates. We aimed to develop and validate a brief instrument that, based on a solid theoretical framework for educational environments, solicits resident feedback to screen the postgraduate medical educational environment quality. Methods Stepwise, we developed a screening instrument, using existing instruments to assess educational environment quality and adopting a theoretical framework that defines three educational environment domains: content, atmosphere and organization. First, items from relevant existing instruments were collected and, after deleting duplicates and items not specifically addressing educational environment, grouped into the three domains. In a Delphi procedure, the item list was reduced to a set of items considered most important and comprehensively covering the three domains. These items were triangulated against the results of semi-structured interviews with 26 residents from three teaching hospitals to achieve face validity. This draft version of the Scan of Postgraduate Educational Environment Domains (SPEED) was administered to residents in a general and university hospital and further reduced and validated based on the data collected. Results Two hundred twenty-three residents completed the 43-item draft SPEED. We used half of the dataset for item reduction, and the other half for validating the resulting SPEED (15 items, 5 per domain). Internal consistencies were high. Correlations between domain scores in the draft and brief versions of SPEED were high (>0.85) and highly significant (p

An algorithm based on consensus method to compute the set of prime implicates of a quantifier free first order formula X was presented in an earlier work. In this paper the notion of prime implicates is extended to theory prime implicates in the first order case. We provide an algorithm to compute the theory prime implicates of a Knowledge base X with respect to another knowledge base Y where both X and Y are assumed to be unquantified first order formulas. The partial correctness of the algorithm is proved. Copyright � 2007 Inderscience Enterprises Ltd.

Purpose The call for clinically relevant outcome criteria has been raised, as assessment of adequate quality of service providers is essential with increasing momentum in the development of palliative care in most European countries. The aim of this study is to investigate important dimensions and indicators for assessment and evaluation of palliative care from the perspective of multi-disciplinary German experts working over years in the field of palliative care. Methods A focus group, using the structured consensus method of the improved nominal group technique (INGT), with nine experts from different disciplines was conducted in Germany. Results An abundance of topics (16) were identified, pointing at the complexity of the issue. Main topics were: quality of life, needs assessments of patients and relatives, resource assessment, surveillance of decision-making processes, as well as spiritual well-being. The following properties were claimed as essential for outcome criteria sensitivity, without additional burden on patients, easy applicability, scientific validity, and helpful for communication within the team, ethical discussions as well as for quality management. Conclusions The study identified topics considered important by experts in clinical practise. The discussions exposed the diversity of demands on outcome assessment put up by different stakeholder groups. This and the high number of relevant items show the complexity for the agreement on a unique set of outcome criteria. Further research considering other perspectives is needed.

Background The process of obtaining informed consent for participation in randomised controlled trials (RCTs) was established as a mechanism to protect participants against undue harm from research and allow people to recognise any potential risks or benefits associated with the research. A number of interventions have been put forward to improve this process. Outcomes reported in trials of interventions to improve the informed consent process for decisions about trial participation tend to focus on the ‘understanding’ of trial information. However, the operationalization of understanding as a concept, the tools used to measure it and the timing of the measurements are heterogeneous. A lack of clarity exists regarding which outcomes matter (to whom) and why. This inconsistency between studies results in difficulties when making comparisons across studies as evidenced in two recent systematic reviews of informed consent interventions. As such, no optimal method for measuring the impact of these interventions aimed at improving informed consent for RCTs has been identified. Methods/Design The project will adopt and adapt methodology previously developed and used in projects developing core outcome sets for assessment of clinical treatments. Specifically, the work will consist of three stages: 1) A systematic methodology review of existing outcome measures of trial informed consent interventions; 2) Interviews with key stakeholders to explore additional outcomes relevant for trial participation decisions; and 3) A Delphi study to refine the core outcome set for evaluation of trial informed consent interventions. All stages will include the stakeholders involved in the various aspects of RCT consent: users (that is, patients), developers (that is, trialists), deliverers (focusing on research nurses) and authorisers (that is, ethics committees). A final consensus meeting including all stakeholders will be held to review outcomes. Discussion The ELICIT study aims to develop a core outcome set for the evaluation of interventions intended to improve informed consent for RCTs for use in future RCTs and reviews, thereby improving the reliability and consistency of research in this area. Electronic supplementary material The online version of this article (doi:10.1186/s13063-015-1011-8) contains supplementary material, which is available to authorized users.

Background This paper describes the structured methods used to involve patients, carers and health professionals in an update of a Cochrane systematic review relating to physiotherapy after stroke and explores the perceived impact of involvement. Methods We sought funding and ethical approval for our user involvement. We recruited a stakeholder group comprising stroke survivors, carers, physiotherapists and educators and held three pre-planned meetings during the course of updating a Cochrane systematic review. Within these meetings, we used formal group consensus methods, based on nominal group techniques, to reach consensus decisions on key issues relating to the structure and methods of the review. Results The stakeholder group comprised 13 people, including stroke survivors, carers and physiotherapists with a range of different experience, and either 12 or 13 participated in each meeting. At meeting 1, there was consensus that methods of categorising interventions that were used in the original Cochrane review were no longer appropriate or clinically relevant (11/13 participants disagreed or strongly disagreed with previous categories) and that international trials (which had not fitted into the original method of categorisation) ought to be included within the review (12/12 participants agreed or strongly agreed these should be included). At meeting 2, the group members reached consensus over 27 clearly defined treatment components, which were to be used to categorise interventions within the review (12/12 agreed or strongly agreed), and at meeting 3, they agreed on the key messages emerging from the completed review. All participants strongly agreed that the views of the group impacted on the review update, that the review benefited from the involvement of the stakeholder group, and that they believed other Cochrane reviews would benefit from the involvement of similar stakeholder groups. Conclusions We involved a stakeholder group in the update of a Cochrane systematic review, using clearly described structured methods to reach consensus decisions. The involvement of stakeholders impacted substantially on the review, with the inclusion of international studies, and changes to classification of treatments, comparisons and subgroup comparisons explored within the meta-analysis. We argue that the structured approach which we adopted has implications for other systematic reviews. Electronic supplementary material The online version of this article (doi:10.1186/s13643-015-0023-5) contains supplementary material, which is available to authorized users.