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Abstract 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

Abstract 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: Trials involving adults who lack capacity to provide consent rely on proxy or surrogate decision-makers, usually a family member, to make decisions about participation. Interventions to enhance proxy decisions about trial participation are now being developed. However, a lack of standardised outcome measures limits evaluation of these interventions. The aim of this study was to establish an agreed standardised core outcome set (COS) for use when evaluating interventions to improve proxy decisions about trial participation.Methods: We used established methods to develop the COS including a consensus study with key stakeholder groups comprising those who will use the COS in research (researchers and healthcare professionals) and patients or their representatives. Following a scoping review to identify candidate items, we used a modified two-round Delphi survey to achieve consensus on core outcomes, with equivocal items taken to a consensus meeting for discussion. The COS was finalised following an online consensus meeting in October 2020.Results: A total of 28 UK stakeholders (5 researchers, 10 trialists, 3 patient/family representatives, 7 recruiters and 3 advisors/approvers) participated in the online Delphi survey to rank candidate items from the scoping review (n = 36) and additional items proposed by participants (n = 1). Items were broadly grouped into three categories: how family members make decisions, their experiences of making decisions, and the personal aspects that influence the decision. Following the Delphi survey, 27 items were included and ten items exhibited no consensus which required discussion at the consensus meeting. Sixteen participants attended the meeting, including additional patient/family representatives invited to increase representation from this key group (n = 2). We reached consensus for the inclusion of 28 outcome items, including one selected at the consensus meeting.Conclusions: The study identified outcomes that should be measured as a minimum in all evaluations of interventions to enhance proxy decisions about trials. These relate to the process of decision-making, proxies' experience of decision-making, and factors that influence decision-making such as understanding. Further work with people with impairing conditions and their families is needed to explore their views about the COS and to identify appropriate outcome measures and timing of measurement.Trial Registration: The study is registered on the COMET database ( https://www.comet-initiative.org/Studies/Details/1409 ). [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Shoulder pain is a highly prevalent condition and a significant cause of morbidity and functional disability. Current data suggests that many patients presenting with shoulder pain at the primary care level are not receiving high quality care. Primary care decision-making is complex and has the potential to influence the quality of care provided and patient outcomes. The aim of this study was to develop a clinical decision-making tool that standardizes care and minimizes uncertainty in assessment, diagnosis, and management. Methods: First a rapid review was conducted to identify existing tools and evidence that could support a comprehensive clinical decision-making tool for shoulder pain. Secondly, provincial consensus was established for the assessment, diagnosis, and management of patients presenting to primary care with shoulder pain in Alberta, Canada using a three-step modified Delphi approach. This project was a highly collaborative effort between Alberta Health Services' Bone and Joint Health Strategic Clinical Network (BJH SCN) and the Alberta Bone and Joint Health Institute (ABJHI). Results: A clinical decision-making tool for shoulder pain was developed and reached consensus by a province-wide expert panel representing various health disciplines and geographical regions. This tool consists of a clinical examination algorithm for assessing, diagnosis, and managing shoulder pain; recommendations for history-taking and identification of red flags or additional concerns; recommendations for physical examination and neurological screening; recommendations for the differential diagnosis; and care pathways for managing patients presenting with rotator cuff disease, biceps pathology, superior labral tear, adhesive capsulitis, osteoarthritis, and instability. Conclusions: This clinical decision-making tool will help to standardize care, provide guidance on the diagnosis and management of shoulder pain, and assist in clinical decision-making for primary care providers in both public and private sectors. [ABSTRACT FROM AUTHOR]

Background: Discharge from acute mental health inpatient units is often a vulnerable period for patients. Multiple professionals and agencies are involved and processes and procedures are not standardized, often resulting in communication delays and co-ordination failures. Early and appropriate discharge planning and standardization of procedures could make inpatient care safer.Aim: To inform the development of a multi-component best practice guidance for discharge planning (including the 6 component SAFER patient flow bundle) to support safer patient transition from mental health hospitals to the community.Methods: Using the RAND/UCLA Appropriateness method, a panel of 10 professional stakeholders (psychiatrists, psychiatric nurses, clinical psychologists, pharmacists, academics, and policy makers) rated evidence-based statements. Six hundred and sixty-eight statements corresponding to 10 potential components of discharge planning best practice were rated on a 9-point integer scale for clarity, appropriateness and feasibility (median ≥ 7–9) using an online questionnaire then remote online face-to-face meetings.Results: Five of the six “SAFER” patient flow bundle components were appropriate and feasible for inpatient mental health. One component, “Early Flow,” was rated inappropriate as mental health settings require more flexibility. Overall, 285 statements were rated as appropriate and feasible. Forty-four statements were considered appropriate but not feasible to implement.Discussion: This consensus study has identified components of a best practice guidance/intervention for discharge planning for UK mental health settings. Although some components describe processes that already happen in everyday clinical interactions (i.e., review by a senior clinician), standardizing such processes could have important safety benefits alongside a tailored and timely approach to post-discharge care.

Abstract Background Some 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. Methods A 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. Results Eighteen 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. Conclusions There 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.

Background: As the development of core outcome sets (COS) increases, guidance for developing and reporting high-quality COS continues to evolve; however, a number of methodological uncertainties still remain. The objectives of this study were: (1) to explore the impact of including patient interviews in developing a COS, (2) to examine the impact of using a 5-point versus a 9-point rating scale during Delphi consensus methods on outcome selection and (3) to inform and contribute to COS development methodology by advancing the evidence base on COS development techniques.Methods: Semi-structured patient interviews and a nested randomised controlled parallel group trial as part of the Pelvic Girdle Pain Core Outcome Set project (PGP-COS). Patient interviews, as an adjunct to a systematic review of outcomes reported in previous studies, were undertaken to identify preliminary outcomes for including in a Delphi consensus survey. In the Delphi survey, participants were randomised (1:1) to a 5-point or 9-point rating scale for rating the importance of the list of preliminary outcomes.Results: Four of the eight patient interview derived outcomes were included in the preliminary COS, however, none of these outcomes were included in the final PGP-COS. The 5-point rating scale resulted in twice as many outcomes reaching consensus after the 3-round Delphi survey compared to the 9-point scale. Consensus on all five outcomes included in the final PGP-COS was achieved by participants allocated the 5-point rating scale, whereas consensus on four of these was achieved by those using the 9-point scale.Conclusions: Using patient interviews to identify preliminary outcomes as an adjunct to conducting a systematic review of outcomes measured in the literature did not appear to influence outcome selection in developing the COS in this study. The use of different rating scales in a Delphi survey, however, did appear to impact on outcome selection. The 5-point scale demonstrated greater congruency than the 9-point scale with the outcomes included in the final PGP-COS. Future research to substantiate our findings and to explore the impact of other rating scales on outcome selection during COS development, however, is warranted. [ABSTRACT FROM AUTHOR]

Abstract Background The concept of informed consent is fundamental to medical practice. Shortcomings in the process can lead to patient complaints, litigation, unmet expectations and poor outcomes. Consent research has focused on developing tools to improve patient recall and understanding. However, the definitions, methods of measurement and timing of measurement vary widely across the studies that have been done. Although a Cochrane review has reported that many of these interventions appear to work, the high level of heterogeneity in outcome reporting prevents the identification of those interventions that work best and why they do so. It is also not clear which outcomes are most important to each party involved in the consent process and why. Methods/design This project will develop a core outcome set for assessing the effects of interventions aimed at improving informed consent for surgery and other invasive procedures for adult patients with the capacity to consent for themselves. We will conduct a systematic review of the qualitative and quantitative literature to identify outcomes used to date in consent research and map these into domains. A series of semi-structured key stakeholder interviews will also be used to identify relevant outcomes. These processes will produce a list of potential outcomes for assessing the effects of interventions to improve consent, which will be refined through an international Delphi survey and consensus webinars involving key stakeholders to produce the core outcome set. Discussion The ICONS study aims to develop a core outcome set for use in trials and reviews of interventions designed to improve the informed consent process for surgery and other invasive procedures. Our aim is that this core outcome set will reduce the level of selection and reporting bias in consent research and help clinicians to compare tools to improve consent.

Abstract 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.

Abstract 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).

Abstract Background Institutions considering to employ core Entrustable Professional Activities (EPAs) for entry into postgraduate training as outcomes for their undergraduate medical programs can partly build on published examples, but also have to undergo their own content validation process to take their specific context into consideration. This process involves several challenges and is not well-described in the literature. Here, we report in detail on a systematic, literature-based approach we recently utilised at our institution to define core EPAs for entry into residency. Main body Central to the process was a modified Delphi consent procedure. It involved a multistep interaction between a writing team and a multidisciplinary panel of experienced physicians. Panel members provided both quantitative ratings and qualitative feedback on the EPA categories title, specification/limitations, conditions and implications of entrustment decision, knowledge, skills, and attitude. Consent was achieved when a Content Validity Index (CVI) of ≥80% was reached. The writing team adjusted the EPA category descriptions on the basis of panel members´ ratings and comments, and specified the EPA categories’ link to competencies and assessment sources. This process produced a description and definition of a full set of core EPAs for entry into residency adapted to our context. Conclusions This process description for locally adapted core EPAs for entry into residency may support and guide other medical schools in the development and implementation of EPAs into their programs.

Abstract Background 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. Methods/design 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. Discussion 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. Trial registration 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: Case-based Interprofessional Education (IPE) can help students practise their roles and responsibilities. To construct these cases, input from experts in clinical practice is essential. Consensus between these experts can be facilitated using consensus methods. In this study, a geriatric focus for the cases was chosen because of the interprofessional nature of geriatrics and the ageing population in healthcare facilities. Methods: By combining the 3 most commonly used consensus methods, we developed a 6-step approach to validate cases for IPE. The 6 steps include 3 expert rounds (Steps 1, 3 and 5) and 2 rounds in which discussion points were formulated by the researcher (Steps 2 and 4). The cases were piloted with students as Step 6. Four facets of a case were included: the patient description, the complemented treatment plan, the difficulty of the case and the scoring of the treatment plan. Our educational setting required constructing 4 cases with increasing difficulty. Results: Step 1: 5 typical geriatric cases were assembled. Step 2: Similar characteristics were defined; 5 cases were merged into 4. The 4 cases showed increasing difficulty levels. Step 3: The constructed cases were validated for patient description authenticity, treatment plan adequacy, difficulty and scoring of the treatment plan. Step 4: The items for further discussion were defined. Step 5: Consensus was reached for all 4 cases through a face-to-face discussion. Step 6: The student pilot for Case 1 showed no significant adjustments. Conclusion: We developed a 6-step consensus method to validate cases for IPE, and we constructed 4 geriatric cases based on this method. While consensus about the patient descriptions and difficulty levels was reached easily, consensus on the treatment plans was more difficult to achieve. Validation of the scoring of the treatment plan was unsuccessful. Further research on this will be conducted. [ABSTRACT FROM AUTHOR]

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 [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract 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.

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.

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.

Deliberative dialogue (DD) may be relatively new in health research but has a rich history in fostering public engagement in political issues. Dialogic approaches are future-facing, comprising structured discussions and consensus building activities geared to the collective identification of actionable and contextualized solutions. Relying heavily on a need for co-production and shared leadership, these approaches seek to garner meaningful collaborations between researchers and knowledge users, such as healthcare providers, decision-makers, patients, and the public. In this commentary, we explore some of the challenges, successes, and opportunities arising from public engagement in DD, drawing also upon insights gleaned from our own research, along with the case study presented by Scurr and colleagues. Specifically, we seek to expand discussions related to inclusion, power, and accessibility in DD, highlight the need for scholarship that addresses the epistemic, methodological, and practical aspects of patient and public engagement within dialogic methods, and identify promising practices., (© 2024 The Author(s); Published by Kerman University of Medical Sciences This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.)

Purpose: Performance assessments are essential to tracking and improving quality in health care systems. Key aspects of the care process that act as indicators must be measured in order to gain an in-depth understanding of a care unit's operation. Without standardized quality indicators (QIs), it is difficult to characterize and compare the abilities of institutions to achieve excellence. The aim of this study is to reach a consensus among glaucoma specialists concerning the development of a set of QIs to assess the performance of glaucoma care units., Methods: A two-round Delphi technique was performed among glaucoma specialists in Portugal, using a 7-point Likert scale. Fifty-three initial statements (comprising process, structure, and outcome indicators) were evaluated and participants had to agree on which ones would be part of the final set of QIs., Results: By the end of both rounds, 28 glaucoma specialists reached consensus on 30/53 (57%) statements, including 19 (63%) process indicators (mainly relating to the proper implementation of complementary exams and the setting of follow-up intervals), 6 (20%) structure indicators, and 5 (17%) outcome indicators. Of the indicators that were part of the final list, functional and structural aspects of glaucoma progression and the availability of surgical/laser procedures were the most prevalent., Conclusions: A set of 30 QIs for measuring the performance of glaucoma units was developed using a consensus methodology involving experts in the field. Their use as measurement standards would provide important information about unit operations and allow further implementation of quality improvements., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The supply chain is a key element of successful operation of businesses in a turbulent economic situation. Swift management of delivery of raw materials and finished products while keeping costs as low as possible and maintaining proper customer service is becoming as vital as the quality and price of a product when gaining competitive advantage. This leads companies to a wide search for the best strategies that allow efficient management of the supply chain. The basic problem, however, is the occurrence of the so-called Forrester effect (also known as the bullwhip effect). It involves intensified transposing of changes in demand onto the execution of product flow in supply chains. The aim of this article is to develop a manner to reduce the Forrester effect using the consensus method. The first part of the article analyzed the current state of knowledge on the discussed problem. Then it presented basic elements of the developed prototype of a SCM system and defined the meth-od for reducing the Forrester effect using a consensus algorithm. The final part of the article de-scribes the way to conduct an experiment that involves verifying the consensus algorithm and analyzes the results of the verification and their influence on the reduction of the Forrester effect. [ABSTRACT FROM AUTHOR]

• Consensus-based methods were used to improve vaccine product label information. • Stakeholders developed structure, language, and content for product labels. • Emergent methods exposed divergent understandings of the purpose of product labels. • Stakeholders were concerned about how product labels are regulated. • Developers of product label information should consider involving end users. Product labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy. To develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels. We conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) meeting, followed by a Delphi survey, and then a consensus workshop with a subset of Delphi participants. We developed a methodological tool to analyse data for consensus. Stakeholders (N = 14) at the NGT meeting drafted product label statements for evaluation in the Delphi survey. Survey participants (N = 41) provided feedback on statements for five hypothetical vaccines. Workshop participants (N = 27) initiated discussions that demonstrated a lack of awareness that the regulatory purpose of product labels is to provide a scientific summary of product-specific pre-clinical and clinical trial data. Each stage of this project built on earlier stages until we achieved strong consensus on the language, structure, and types of data that stakeholders wanted to include in inactivated influenza vaccine (IIV) and tetanus-diphtheria-acellular pertussis (Tdap) vaccine product labels in Canada. The revised statements for IIV and Tdap aligned with workshop participants' goals that the product label be evidence-based, with a consistent structure and language that is easily understood by healthcare providers. Emergent methods uncovered stakeholder concerns about the regulatory purpose, content, and evidence used in product labels. Involving healthcare providers in the development and regular updating of product information could prevent interpretations of that information that contribute to vaccine hesitancy. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Rationale, aims, and objectives: Clinical practice guidelines (CPGs) endeavour to incorporate the best available research evidence together with the clinically informed opinions of leading experts in order to guide clinical practice when dealing with a given condition. There has been increased interest in CPGs that are evidence based and that promote best practice, a central component of which is incorporating the best available research predicated on strong study designs. Despite this soaring interest, there remains heterogeneity in the methodological quality of many CPGs, which may have an effect on the quality of services that clinicians offer. In light of this, this study examined the quality of the methodology used to develop two CPGs of the Canadian Psychiatric Association (CPA). Method: The CPA's guidelines for the management of anxiety disorders (2006) and for the treatment of depressive disorders (2001) were assessed by trained raters using the Appraisal of Guidelines for Research and Evaluation II Instrument scale. Results: The blind ratings of three trained raters demonstrated that the anxiety and depression CPGs had a number of strengths and important weaknesses. Conclusion: Implications for the development of future CPGs on anxiety and depression, including recommendations to improve guideline quality in psychiatry in particular, are discussed. [ABSTRACT FROM AUTHOR]

Objective: Given the complexity and heterogeneity of systemic lupus erythematosus (SLE), high-performing classification criteria are critical to advancing research and clinical care. A collaborative effort by the European League Against Rheumatism and the American College of Rheumatology was undertaken to generate candidate criteria, and then to reduce them to a smaller set. The objective of the current study was to select a set of criteria that maximizes the likelihood of accurate classification of SLE, particularly early disease.Methods: An independent panel of international SLE experts and the SLE classification criteria steering committee (conducting SLE research in Canada, Mexico, United States, Austria, Germany, Greece, France, Italy, and Spain) ranked 43 candidate criteria. A consensus meeting using nominal group technique (NGT) was conducted to reduce the list of criteria for consideration.Results: The expert panel NGT exercise reduced the candidate criteria for SLE classification from 43 to 21. The panel distinguished potential "entry criteria," which would be required for classification, from potential "additive criteria." Potential entry criteria were antinuclear antibody (ANA) ≥ 1:80 (HEp-2 immunofluorescence), and low C3 and/or low C4. The use of low complement as an entry criterion was considered potentially useful in cases with negative ANA. Potential additive criteria included lupus nephritis by renal biopsy, autoantibodies, cytopenias, acute and chronic cutaneous lupus, alopecia, arthritis, serositis, oral mucosal lesions, central nervous system manifestations, and fever.Conclusion: The NGT exercise resulted in 21 candidate SLE classification criteria. The next phases of SLE classification criteria development will require refinement of criteria definitions, evaluation of the ability to cluster criteria into domains, and evaluation of weighting of criteria. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract 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. [ABSTRACT FROM AUTHOR]

Monica C Robotin,1,2 Muthau Shaheem,3 Aishath S Ismail3 1Faculty of Medicine, School of Public Health, University of Sydney, 2Cancer Programs Division, Cancer Council New South Wales, Sydney, Australia; 3Faculty of Health Sciences, Maldives National University, Male, Maldives 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. Keywords: public health, education, MPH, curriculum development, consensus methods

There is increasing recognition of the need for researchers to collect and report data that can illuminate health inequities. In pain research, routinely collecting equity-relevant data has the potential to inform about the generalisability of findings; whether the intervention has differential effects across strata of society; or it could be used to guide population targeting for clinical studies. Developing clarity and consensus on what data should be collected and how to collect it is required to prompt researchers to further consider equity issues in the planning, conduct, interpretation, and reporting of research. The overarching aim of the 'Identifying Social Factors that Stratify Health Opportunities and Outcomes' (ISSHOOs) in pain research project is to provide researchers in the pain field with recommendations to guide the routine collection of equity-relevant data. The design of this project is consistent with the methods outlined in the 'Guidance for Developers of Health Research Reporting Guidelines' and involves 4 stages: (i) Scoping review; (ii) Delphi Study; (iii) Consensus Meeting; and (iv) Focus Groups. This stakeholder-engaged project will produce a minimum dataset that has global, expert consensus. Results will be disseminated along with explanation and elaboration as a crucial step towards facilitating future action to address avoidable disparities in pain outcomes., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: ELK has received speaker fees for lectures on pain and rehabilitation from professional and scientific bodies, and reimbursement of travel costs related to presentations at scientific conferences/symposia. GLM has received support from: Reality Health, ConnectHealth UK, Institutes of Health California, AIA Australia, Workers’ Compensation Boards and professional sporting organizations in Australia, Europe, South and North America. Professional and scientific bodies have reimbursed him for travel costs related to presentation of research on pain and pain education at scientific conferences/symposia. He has received speaker fees for lectures on pain, pain education and rehabilitation and conference travel support from Sequirus. He receives royalties for books on pain and pain education. PT has received consulting fees to provide independent medical consultation and professional services. He is an independent Committee Member for clinical trial Data Safety Monitoring Boards for FDA approved trials being conducted by UCB Biopharma GmbH & SPRL, Parexel International, Prahealth Sciences. PT is an [unpaid] Chair of the Management Subcommittee of the Executive Committee of a registered non-profit independent medical research organization, OMERACT. OMERACT receives unrestricted educational grants from the American College of Rheumatology, European League of Rheumatology and several pharmaceutical companies listed in this section, which is used to support fellows, international patient groups and support a major international bi-annual conference which results in many peer-reviewed publications. There are no competing interests for any other author., (© 2023 The Authors. Published by Elsevier B.V.)

Objective: Hospital boards are legally responsible for the quality of care delivered by healthcare professionals in their hospitals, but experience difficulties in overseeing quality and safety risks. This study aimed to select a core set of parameters for boards to govern quality of care in the intensive care unit (ICU).Design: Two-round Delphi study.Setting: Two university hospitals in the Netherlands.Participants: An expert panel of 12 former ICU patients or their family members, 12 ICU nurses, 12 ICU physicians and 12 members of boards of directors and quality managers.Main Outcome Measures: Participants indicated the relevance of existing parameters for assessing the quality of ICU care for governance purposes (round 1) and selected 10 quality parameters that together provide boards of directors with a good representation of quality of care in their ICU (round 2).Results: We identified 122 quality parameters related to care in the ICU, which we limited to a short list to present to participants in round 1. The response rate was 94% in round 1 and 85% in round 2. The final set consisted of the 10 most frequently selected quality parameters per hospital. Five parameters were included in both sets; all related to patient safety and continuous quality improvement.Conclusions: Parameters in the core set were mostly qualitative and generic, rather than quantitative and ICU-specific in nature. To engage in a true dialog about quality of care, boards are more interested in the story behind the numbers than in just the numbers themselves. [ABSTRACT FROM AUTHOR]

Objectives: To identify areas of agreement and disagreement in the implementation of multi‐parametric magnetic resonance imaging (mpMRI) of the prostate in the diagnostic pathway. Materials and Methods: Fifteen UK experts in prostate mpMRI and/or prostate cancer management across the UK (involving nine NHS centres to provide for geographical spread) participated in a consensus meeting following the Research and Development Corporation and University of California‐Los Angeles (UCLA‐RAND) Appropriateness Method, and were moderated by an independent chair. The experts considered 354 items pertaining to who can request an mpMRI, prostate mpMRI protocol, reporting guidelines, training, quality assurance (QA) and patient management based on mpMRI levels of suspicion for cancer. Each item was rated for agreement on a 9‐point scale. A panel median score of ≥7 constituted ‘agreement’ for an item; for an item to reach ‘consensus’, a panel majority scoring was required. Results: Consensus was reached on 59% of items (208/354); these were used to provide recommendations for the implementation of prostate mpMRI in the UK. Key findings include prostate mpMRI requests should be made in consultation with the urological team; mpMRI scanners should undergo QA checks to guarantee consistently high diagnostic quality scans; scans should only be reported by trained and experienced radiologists to ensure that men with unsuspicious prostate mpMRI might consider avoiding an immediate biopsy. Conclusions: Our consensus statements demonstrate a set of criteria that are required for the practical dissemination of consistently high‐quality prostate mpMRI as a diagnostic test before biopsy in men at risk. [ABSTRACT FROM AUTHOR]

Abstract: 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. 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 risk‐assessment scheme should include. 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. 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background. Up to 5% of women in the UK will receive maternity high dependency care (MHDC), although there are varying opinions as to the defining features of this concept. This paper describes the rationale for, and design of, a modified threeround Delphi survey examining MHDC. Objectives. To obtain a consensus on the definition and defining features of MHDC in obstetric units (OUs) remote from a tertiary referral centre. To examine if the definition for, and defining features of MHDC are the same for OUs remote from tertiary referral centres with differing annual birth rates. To investigate if the definition for, and defining features of MHDC are the same for the professional groups of doctors and midwives working in OUs with similar annual birth rates. Method. The Delphi participants comprised midwives, obstetricians, and anaesthetists employed in seven OUs. Round one (qualitative) involved completion of a self-report questionnaire. During rounds two and three (quantitative), respondents rated their level of agreement or disagreement against five-point Likert items for a series of statements (n=106). The level of consensus for the combined percentage of strongly agree and agree statements was set at 80% for the second and third rounds. The round two statistical findings were not fed back to the respondents but, they were given the opportunity to provide additional qualitative comments throughout the second and third rounds. Ethical approval was granted by the local research ethics committee and the relevant NHS research and development departments. Conclusion. Where modifications are made to traditional Delphi surveys, the researcher must carefully justify the methodological decisions that have been taken. [ABSTRACT FROM AUTHOR]

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 health care 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 is agreed as critically important for deciding whether a treatment for subjective tinnitus is effective. Such a recommendation would help to standardise future clinical trials worldwide and so we will determine if participation increases use of the Core Outcome Set in the long term.Trial Registration: This project has been registered (November 2014) in the database of the Core Outcome Measures in Effectiveness Trials (COMET) initiative. [ABSTRACT FROM AUTHOR]

The most recent data show that shellfish farming represents approximately 60% of the total aquaculture production in Europe. Bivalves molluscs are internationally recognized as a potential vehicle for foodborne diseases especially when consumed raw or improperly cooked. Bivalves are filter-feeding animals that may accumulate particles present in the surrounding water, including viruses and pathogenic microorganisms. For these reasons consumers have to be careful during purchasing, handling and cooking of this food. In Europe several regulations have been adopted to protect consumers’ health. However in the development of new food safety strategies it is also crucial to find an effective approach to guide authorities’ decisions on priorities for controlling foodborne risks. In the article a study for the selection and ranking of behavioural information on bivalve risks is reported. The “consensus methods” provide a means of synthesising information and of harnessing the insights of experts to enable decisions shared and validated by the scientific community. The Delphi method and Nominal Group technique (NGT) were applied for their capability to assess the level of agreement and to develop consensus among participants. In the article, the NGT is presented as a way to involve relevant stakeholders in the ranking of risky behaviours from the production to the consumption of bivalve molluscs previously selected by scientific experts through the Delphi method. The inclusion of a full range of experts and stakeholders in a community participatory research project regarding food risk management represents an innovative approach in the Italian public health context, especially in the analysis of bivalve risks. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]