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Objective: : To develop an international Core Outcome Set (COS), a minimal collection of outcomes that should be measured and reported in all future clinical trials evaluating treatments of acute simple appendicitis in children.Summary Background Data: A previous systematic review identified 115 outcomes in 60 trials and systematic reviews evaluating treatments for children with appendicitis, suggesting the need for a COS.Methods: The development process consisted of four phases: (1) an updated systematic review identifying all previously reported outcomes, (2) a two-stage international Delphi study in which parents with their children and surgeons rated these outcomes for inclusion in the COS, (3) focus groups with young people to identify missing outcomes, and (4) international expert meetings to ratify the final COS.Results: The systematic review identified 129 outcomes which were mapped to 43 unique outcome terms for the Delphi survey. The first-round included 137 parents (eight countries) and 245 surgeons (10 countries), the second-round response rates were 61% and 85% respectively, with ten outcomes emerging with consensus. After two young peoples’ focus groups, two additional outcomes were added to the final COS (12): mortality, bowel obstruction, intra-abdominal abscess, recurrent appendicitis, complicated appendicitis, return to baseline health, readmission, reoperation, unplanned appendectomy, adverse events related to treatment, major and minor complications.Conclusion: An evidence-informed COS based on international consensus, including patients and parents has been developed. This COS is recommended for all future studies evaluating treatment of simple appendicitis in children, to reduce heterogeneity between studies and facilitate data synthesis and evidence-based decision-making.

Background Value-based contracts that tie payments for pharmaceuticals to predefined outcomes aim to promote value through shared risk and aligned incentives between manufacturers and payers. Methods We conducted a Delphi study among diverse stakeholders (patients, providers, payers, pharmacy benefits managers, pharmaceutical company representatives) to identify top meaningful outcomes for inclusion in value-based contracts for atrial fibrillation medications. The final panel (n = 55) rated the importance of each outcome on a 5-point Likert scale and selected their top 3 most meaningful outcomes. Non-patient participants rated the feasibility of collecting each outcome on a 5-point Likert scale. Consensus was defined as ≥75% agreement (Likert scores ≥4/5 or selection of an outcome as most meaningful). Differences between stakeholder groups were examined using Fisher's Exact Test. Results Consensus was achieved for importance of 10 outcomes (Likert scale), where “preventing stroke or mini-stroke” reached 100% agreement (55/55). Eighty-one percent (44/54) of participants selected “preventing stroke or mini-stroke” as the most meaningful outcome (rank order question). The measures rated as most feasibly collected were “reducing hospitalizations” (97%, 36/37) followed by “preventing stroke or mini-stroke” and “reducing emergency department visits” (both 92%, 34/37). There were statistically significant differences between patients and non-patients [0% (0/17) vs 22% (8/37), P = 0.047] and patients and providers [0% (0/17) vs 39% (7/18), P = 0.008] in selection of “improving health-related quality of life” as a most meaningful outcome. Conclusions These findings will inform the design of atrial fibrillation value-based pharmaceutical contracts and provide additional insight into preferences for outcomes which could be used to improve the quality of atrial fibrillation care.

Background Communication interventions for childhood vaccination are promising strategies to address vaccine hesitancy, but current research is limited by the outcomes measured. Most studies measure only vaccination-related outcomes, with minimal consideration of vaccine hesitancy-relevant intermediate outcomes. This impedes understanding of which interventions or elements are effective. It is also unknown which outcomes are important to the range of stakeholders affected by vaccine hesitancy. Outcome selection shapes the evidence base, informing future interventions and trials, and should reflect stakeholder priorities. Therefore, our aim was to identify which outcome domains (i.e. broad outcome categories) are most important to different stakeholders, identifying preliminary core outcome domains to inform evaluation of three common vaccination communication types: (i) communication to inform or educate, (ii) remind or recall, and (iii) enhance community ownership. Methods We conducted a two-stage online Delphi survey, involving four stakeholder groups: parents or community members, healthcare providers, researchers, and government or non-governmental organisation representatives. Participants rated the importance of eight outcome domains for each of the three communication types. They also rated specific outcomes within one domain (“attitudes or beliefs”) and provided feedback about the survey. Results Collectively, stakeholder groups prioritised outcome domains differently when considering the effects of different communication types. For communication that aims to (i) inform or educate, the most important outcome domain is “knowledge or understanding”; for (ii) reminder communication, “vaccination status and behaviours”; and for (iii) community engagement communication, “community participation”. All stakeholder groups rated most outcome domains as very important or critical. The highest rated specific outcome within the “attitudes or beliefs” domain was “trust”. Conclusion This Delphi survey expands the field of core outcomes research and identifies preliminary core outcome domains for measuring the effects of communication about childhood vaccination. The findings support the argument that vaccination communication is not a single homogenous intervention – it has a range of purposes, and vaccination communication evaluators should select outcomes accordingly.

Background Maternal satisfaction with maternity care is an important indicator of quality maternity services. Continuity of midwifery models of care are increasing in Australia and while several instruments have been developed to measure satisfaction with maternity care most of these have not been validated and there are none that are appropriate to continuity of midwifery maternity care models. Aim To develop a questionnaire to measure women’s satisfaction with maternity services provided in a continuity of midwifery care service model. Methods A modified Delphi technique was used. A heterogenous panel of eight experts provided feedback over four rounds. The starting point for the questionnaire was informed by two systematic literature reviews focusing on available instruments for measuring maternal satisfaction with maternity care and what women value continuity of midwifery models of care. Findings The Continuity of Midwifery Care Satisfaction Survey (COMcareSS) was developed after four rounds of feedback with the expert panel. The survey comprises nine domains and fifty-nine questions. The domains include demographics, maternity care outcomes, facilities, the midwife/woman relationship, building capacity-empowerment, decision making and involvement, personalised care, advice care and support and general. Conclusions Consumer satisfaction is an important indicator of quality care. This is the first instrument to be developed that is appropriate to continuity of midwifery models of care. The important next step is to pilot test the instrument to establish its validity and reliability.

Background The purpose of this study was to determine if observational therapy is noninferior to antibiotics for acute uncomplicated diverticulitis according to clinically relevant margins. Methods MEDLINE, EMBASE, and Cochrane were systematically searched by 2 independent reviewers to identify comparative studies of observational therapy versus antibiotics for acute uncomplicated diverticulitis. Non-inferiority margins (ΔNI) for each outcome were based on Delphi consensus including 50 patients and 55 physicians: persistent diverticulitis (ΔNI = 4.0%), progression to complicated diverticulitis (ΔNI = 3.0%), and time to recovery (ΔNI = 5 days). Risk differences and mean differences were pooled using random-effects meta-analysis. One-sided 90% confidence intervals and Z-tests were used to determine non-inferiority. A sensitivity analysis was performed, excluding patients post hoc determined to have complicated diverticulitis. Results Nine studies (3 randomized controlled trials, 6 observational studies) met inclusion criteria: observational therapy (n = 2,011) versus antibiotics (n = 1,144). Observational therapy was noninferior to antibiotics regarding the risk of persistent diverticulitis (pooled risk differences: -0.39%, 90% CI -3.22 to 2.44%, ΔNI: 4.0%, PNI Conclusion According to clinically relevant ΔNIs, observational therapy was noninferior to antibiotics for the treatment of acute uncomplicated diverticulitis with regard to persistent diverticulitis and progression to complicated diverticulitis.

Supported by the National Health and Medical Research Council Centre of Research Excellence in Pulmonary Fibrosis (GNT1116371), and by foundation partner, Boehringer Ingelheim, and program partners, Roche and Galapagos. Rationale : The interstitial lung disease (ILD) multidisciplinary meetings (MDM), composed of pulmonologists, radiologists, and pathologists, is integral to the rendering of an accurate ILD diagnosis. However, there is significant heterogeneity in the conduct of ILD MDMs, and questions regarding their best practices remain unanswered. Objectives : To achieve consensus among ILD experts on essential components of an ILD MDM. Methods : Using a Delphi methodology, semi-structured interviews with ILD experts were used to identify key themes and features of ILD MDMs. These items informed two subsequent rounds of online questionnaires that were used to achieve consensus among a broader, international panel of ILD experts. Experts were asked to rate their level of agreement on a five-point Likert scale. An a priori threshold for consensus was set at a median score 4 or 5 with an interquartile range of 0. Results : We interviewed 15 ILD experts, and 102 ILD experts participated in the online questionnaires. Five items and two exploratory statements achieved consensus on being essential for an ILD MDM following two questionnaire rounds. There was consensus that the presence of at least one radiologist, a quiet setting with a visual projection system, a high-quality chest high-resolution computed tomography, and a standardized template summarizing collated patient data are essential components of an ILD MDM. Experts also agreed that it would be useful for ILD MDMs to undergo an annual benchmarking process and a validation process by fulfilling a minimum number of cases annually. Twenty-seven additional features were considered to be either highly desirable or desirable features based on the degree of consensus. Although our findings on desirable features are similar to the current literature, several of these remain controversial and warrant further research. The study also showed an agreement among participants on several future concepts to improve the ILD MDM, such as performing regular self-assessments and conducting research into shared practices to develop an international expert guideline statement on ILD MDMs. Conclusions : This Delphi study showed consensus among international ILD experts on essential and desirable features of an ILD MDM. Our data represent an important step toward potential collaborative research into future standardization of ILD MDMs. Postprint

OBJECTIVE: The aim was to develop a reliable surgical quality assurance system for 2-stage esophagectomy. This development was conducted during the pilot phase of the multicenter ROMIO trial, collaborating with international experts.SUMMARY OF BACKGROUND DATA: There is evidence that the quality of surgical performance in randomized controlled trials influences clinical outcomes, quality of lymphadenectomy and loco-regional recurrence.METHODS: Standardization of 2-stage esophagectomy was based on structured observations, semi-structured interviews, hierarchical task analysis, and a Delphi consensus process. This standardization provided the structure for the operation manual and video and photographic assessment tools. Reliability was examined using generalizability theory.RESULTS: Hierarchical task analysis for 2-stage esophagectomy comprised fifty-four steps. Consensus (75%) agreement was reached on thirty-nine steps, whereas fifteen steps had a majority decision. An operation manual and record were created. A thirty five-item video assessment tool was developed that assessed the process (safety and efficiency) and quality of the end product (anatomy exposed and lymphadenectomy performed) of the operation. The quality of the end product section was used as a twenty seven-item photographic assessment tool. Thirty-one videos and fifty-three photographic series were submitted from the ROMIO pilot phase for assessment. The overall G-coefficient for the video assessment tool was 0.744, and for the photographic assessment tool was 0.700.CONCLUSIONS: A reliable surgical quality assurance system for 2-stage esophagectomy has been developed for surgical oncology randomized controlled trials.ETHICAL APPROVAL: 11/NW/0895 and confirmed locally as appropriate, 12/SW/0161, 16/SW/0098.TRIAL REGISTRATION NUMBER: ISRCTN59036820, ISRCTN10386621.

Background Over the last decade, preoperative anemia has become recognized as a clinical condition in need of management. Although the etiology of preoperative anemia can be multifactorial, two-thirds of anemic elective surgical patients have iron deficiency anemia. At the same time, one-third of non-anemic elective surgical patients are also iron deficient. Methods Modified-RAND Delphi methodology was employed to identify areas of consensus among an expert panel regarding the management of iron deficiency in patients undergoing cardiac surgery. A list of statements was sent to panel members to respond to using a five-point Likert Scale. All panel members subsequently attended a face-to-face meeting. The initial survey was presented and discussed, and panel members responded to each statement on the Likert scale again. Based on the second survey, the panel came to a consensus on recommendations. Results The panel recommended all patients undergoing cardiac surgery be evaluated for iron deficiency, whether or not anemia is present. Evaluation should include iron studies and reticulocyte hemoglobin content. If iron deficiency is present, with or without anemia, patients should receive parenteral iron. Erythropoietin stimulating agents may be appropriate for some patients. Conclusions Consensus of an expert panel resulted in a standardized approach to diagnosing and managing iron deficiency in patients undergoing cardiac surgery.

Background Effects of the institutional macrocosm on general surgery resident wellbeing have not been well studied. We sought to identify organizational factors that impact resident wellness and burnout. Methods Using a modified Delphi technique, an open-ended survey and two subsequent iterations were distributed to wellness stakeholders at two institutions to identify and stratify institutional factors in six burnout domains. Results Response rates for each survey round were 29/106 (27%), 30/46 (65%) and 21/30 (70%). Top factors identified in each domain were: • Workload: hours (60% respondents), advanced practice providers (53%) • Control: autonomy (77%), scheduling blocks/changes (43%) • Rewards: compensation (93%), vacation (83%) • Community: peer support (66%) and mentorship programs (59%) • Fairness: budget allocation (48%), resident union (48%) • Values: mentorship program (43%), institution type (40%) Conclusion A modified Delphi technique prioritized institutional wellness and burnout factors. Top factors identified were compensation, vacation time, and autonomy. These results can direct future scholarship of barriers/facilitators of resident wellbeing.

Purpose The intravitreal dexamethasone implant (DEX-I) is an alternative to anti-VEGF for the first-line treatment of diabetic macular oedema (DME). However, several questions remain regarding its routine use and its place in certain situations not always specified in current recommendations. A national consensus approach was, therefore, initiated by French retinal experts. Methods An iterative Delphi consensus approach was used. A steering committee (SC) of seven experts analysed data from the literature to formulate statements divided into five key areas of treatment. These statements were submitted to the independent and anonymous electronic vote of 87 French retina experts among whom 39 expressed their opinion and therefore constituted the voting panel. Results After two rounds of voting, 22 and 7 of 38 statements received a strong consensus and a good consensus, respectively. The consensus level was higher for statements regarding first-line indications and safety of DEX-I compared to those regarding efficacy assessment, reprocessing time or pathophysiological biomarkers. The panellists recommended the preferential use of DEX-I for patients with limited availability for multiple injections, those who needed to undergo cataract surgery or who had a recent cardiovascular history, and as a therapeutic alternative to anti-VEGF in patients with a history of vitrectomy, retinal serous detachment, hyper-reflective points or dry exudates in optical coherence tomography (OCT). However, some statements proposed by SC experts were not validated. Conclusion This study provides some key recommendations to clinicians treating diabetic macular oedema, which may be useful when using intravitreal dexamethasone implants in daily practice.

Background Proximal humerus fracture (PHF) complications, whether following surgery or nonoperative management, require standardization of definitions and documentation for consistent reporting. We aimed to define an international consensus core event set (CES) of clinically-relevant unfavorable events of PHF to be documented in clinical routine practice and research. Methods A Delphi exercise was implemented with an international panel of experienced shoulder trauma surgeons selected by survey invitation of AO Trauma members. An organized list of PHF events after nonoperative or operative management was developed and reviewed by panel members using on-line surveys. The proposed core set was revised regarding event groups along with definitions, specifications and timing of occurrence. Consensus was reached with at least a two-third agreement. Results The PHF consensus panel was composed of 231 clinicians worldwide who responded to at least one of two completed surveys. There was 93% final agreement about three intraoperative local event groups (device, osteochondral, soft tissue). Postoperative or nonoperative event terms and definitions organized into eight groups (device, osteochondral, shoulder instability, fracture-related infection, peripheral neurological, vascular, superficial soft tissue, deep soft tissue) were approved with 96 to 98% agreement. The time period for documentation ranged from 30 days to 24 months after PHF treatment depending on the event group and specification. The resulting consensus was presented on a paper-based PHF CES documentation form. Conclusions International consensus was achieved on a core set of local unfavorable events of PHF to foster standardization of complication reporting in clinical research and register documentation. Trial registration Not applicable.

Background Internationally, nurses are gaining recognition for their contributions to public health and global health initiatives, however, their contributions to surveillance and the detection of new and emerging infectious disease, which is an important element of global health security, remain largely unknown. Purpose The purpose of this study was to investigate the perceptions of nurse experts related to the current and optimal roles of nurses in surveillance of new and emerging infectious diseases. Additionally, this study aimed to identify the skills needed by nurses in all practice settings for optimal performance of surveillance and to identify barriers to achieving optimal performance of surveillance. Methods A three-round Delphi study was conducted. Nurse experts participated in Round 1 interviews followed by ranking current and optimal role, skill, and barrier statements in Rounds 2 and 3. Findings Findings revealed four current roles and 13 optimal roles for nurses in surveillance, 13 skills needed to perform surveillance activities, and seven barriers to optimal performance of surveillance activities by nurses. Disucssion Results of this study are intended to inform nursing practice and education in the U.S., and to provide guidance on the role of nurses in surveillance of new and emerging infectious disease as part of the Global Health Security Agenda.

Aim To identify a set of scientific, systematic and clinically applicable nursing‐sensitive quality indicators for pernicious placenta previa (PPP). Design A modified Delphi‐Consensus Technique. Methods According to literature retrieval published between 2009–2019, 38 nursing‐sensitive quality indicators were chosen and a questionnaire was designed. An online survey was conducted in 20 hospitals in China, and data of experts’ opinions were collected and analysed by improved Delphi method. Results 38 nursing‐sensitive quality indicators were identified. The response rates in the two rounds of expert consultation were 97.4% and 100%, and the authoritative coefficients were 0.89 and 0.92. The coefficients of variation ranged from 0.04–0.28. The nursing‐sensitive quality indicators were successfully constructed based on the modified Delphi technique.

Objective Helicobacter pyloriinfection is mostly a family-based infectious disease. To facilitate its prevention and management, a national consensus meeting was held to review current evidence and propose strategies for population-wide and family-basedH. pyloriinfection control and management to reduce the related disease burden. Methods Fifty-seven experts from 41 major universities and institutions in 20 provinces/regions of mainland China were invited to review evidence and modify statements using Delphi process and grading of recommendations assessment, development and evaluation system. The consensus level was defined as ≥80% for agreement on the proposed statements. Results Experts discussed and modified the original 23 statements on family-basedH. pyloriinfection transmission, control and management, and reached consensus on 16 statements. The final report consists of three parts: (1)H. pyloriinfection and transmission among family members, (2) prevention and management ofH. pyloriinfection in children and elderly people within households, and (3) strategies for prevention and management ofH. pyloriinfection for family members. In addition to the ‘test-and-treat’ and ‘screen-and-treat’ strategies, this consensus also introduced a novel third ‘family-basedH. pyloriinfection control and management’ strategy to prevent its intrafamilial transmission and development of related diseases. Conclusion H. pyloriis transmissible from person to person, and among family members. A family-basedH. pyloriprevention and eradication strategy would be a suitable approach to prevent its intra-familial transmission and related diseases. The notion and practice would be beneficial not only for Chinese residents but also valuable as a reference for other highly infected areas.

Objective To obtain expert consensus on indicators of quality rehabilitation services for individuals with limited English proficiency (LEP). Design Three-round Delphi study. Setting Delphi survey conducted online with 30 experts. Most experts worked in adult physical rehabilitation settings and were from Illinois (n=16), with remaining participants from eight other US states or Canadian provinces. Participants Experts had a minimum of two publications on healthcare services for patients with LEP and/or a minimum of five years clinical experience in physical rehabilitation. Of 43 experts (11 researchers, 32 clinicians) emailed the Round One survey, 30 returned complete responses (70% response rate). Of those, 25 completed Round Two, and 24 completed Round Three. Of Round One participants, most (n =21) identified their primary professional activity as clinical, whereas the others worked in research (n =5) or education (n =4). Twenty-four were female. Median age was 43 (range 27-67). Disciplines included occupational therapy (n =14), physical therapy (n =13), psychology (n=1), nursing (n=1), and medicine (n=1). Interventions Not applicable. Main outcome measures Indicators rated on a seven-point Likert scale for importance and feasibility. Interquartile range (IQR) and 95% confidence intervals calculated for importance and feasibility ratings. Indicators with an IQR Results Round One responses were categorized into 15 structural, 13 process and 18 outcome indicators. All 15 structural indicators reached consensus for importance; eight were rated as feasible. All 13 process indicators reached consensus, of which eight were deemed feasible. Sixteen outcome indicators reached consensus, of which seven were deemed feasible. Conclusions This Delphi study identified structural, process, and outcome indicators that can inform delivery and assessment of quality rehabilitation services for individuals with limited English proficiency. Future research should operationalize and measure these quality indicators in clinical practice.

International audience; Background: Congenital melanocytic naevi (CMN) can have a great impact on patients' lives owing to perceived stigmatization, and the risk of melanoma development and neurological complications. Development of a core outcome set (COS) for care and research in CMN will allow standard reporting of outcomes. This will enable comparison of outcomes, allowing professionals to offer advice about the best management options. In previous research, stakeholders (patients, parents and professionals) reached consensus on the core domains of the COS. To select the appropriate measurement instruments, the domains should be specified by outcomes.Objectives: To reach consensus on the specific core outcomes describing the core domains pertaining to clinical care and research in CMN.Methods: A list of provisional outcomes (obtained earlier) was critically reviewed by the Outcomes for COngenital MElanocytic Naevi (OCOMEN) research team and by relevant stakeholders through an online questionnaire, to refine this list and provide clear definitions for every outcome. When needed, discussion with individual participants was undertaken over the telephone or by email. During an online consensus meeting, stakeholders discussed the inclusion of potential outcomes. After the meeting, participants voted in two rounds for the inclusion of outcomes.Results: Forty-four stakeholders from 19 countries participated. Nine core outcomes were included in the COS relative to clinical care and 10 core outcomes for research.Conclusions: These core outcomes will enable standard reporting in future care and research of CMN. This study facilitates the next step of COS development: selecting the appropriate measurement instruments for every outcome.

OBJECTIVES Hypertension is among the most commonly managed diseases in general practice. Therapeutic inertia could be responsible for the vast majority of cardiovascular events in patients with hypertension. The present study was conducted to explore views and opinions of clinicians involved in providing health care services to patients with hypertension in Palestine and achieve formal consensus on promoters of the phenomenon of therapeutic inertia from their point of view. STUDY DESIGN In this exploratory study, a mixed-methods approach combining literature search, qualitative interviews, and 2 Delphi technique rounds was used. METHODS Interviews with key contact clinicians (n = 18) were conducted. To achieve formal consensus on promoters of therapeutic inertia in hypertension, 2 Delphi rounds were conducted using a panel of general practitioners, family medicine specialists, and internal medicine specialists (n = 50). RESULTS The majority of the panel members (90%) agreed that therapeutic inertia was prevalent in treating patients with hypertension in Palestine. Of the 41 potential promoters, consensus was achieved on 37 (90.2%). Of these 37 promoters, 21 (56.8%) were clinician-related, 10 (27.0%) were patient-related, and 6 (16.2%) were health care system-related factors. The study explored views and opinions of clinicians involved in providing health care services to patients with hypertension in Palestine relevant to therapeutic inertia in hypertension. CONCLUSIONS Findings of this study could inform policy and decision makers to devise strategies to eliminate or reduce therapeutic inertia in managing hypertension in Palestinian clinical practice. Future studies are needed to determine whether such strategies can improve outcomes of patients with hypertension.

Objectives: To develop criteria for identifying potentially inappropriate prescribing of medications for symptomatic relief in older adults (≥65 years) with cancer who are receiving palliative care and have an estimated life expectancy of Materials and methods: A two-round Delphi exercise was conducted using web-based questionnaires. A panel of 18 expert stakeholders with expertise in palliative care, oncology and/or geriatric medicine across Ireland and the United Kingdom rated their level of agreement with each statement using a 5-point Likert scale and had the option of adding free-text comments throughout the questionnaire. A priori decision rules were used to accept or reject criteria. Results: Twenty-eight criteria were presented in Round 1. Group consensus was achieved for 15 criteria which were included in the final set of criteria. Following a review of the panel's ratings and additional comments for the remaining 13 criteria, four criteria were removed from Round 2. Group consensus was achieved for all nine criteria included in Round 2. The final set comprised 24 criteria relating to: anorexia-cachexia (n = 1); anxiety (n = 2); constipation (n = 5); delirium (n = 1); depression (n = 3); diarrhoea (n = 1); dyspnoea/breathlessness (n = 1); fatigue (n = 2); insomnia (n = 2); nausea and vomiting (n = 2); pain (n = 3); duplicate drug classes (n = 1). Conclusion: A consensus-agreed set of prescribing criteria has been developed for identifying potentially inappropriate prescribing of medications for symptomatic relief in older adults with cancer who are receiving palliative care and have an estimated life expectancy of less than one year. Future studies should examine the application and validity of these criteria.

Objective To develop a minimum data set, known as a core outcome set, for future abortion randomized controlled trials. Study design We extracted outcomes from quantitative and qualitative systematic reviews of abortion studies to assess using a modified Delphi method. Via email, we invited researchers, clinicians, patients, and healthcare organization representatives with expertise in abortion to rate the importance of the outcomes on a 9-point Likert scale. After 2 rounds, we used descriptive analyses to determine which outcomes met the predefined consensus criteria. We finalized the core outcome set during a series of consensus development meetings. Results We entered 42 outcomes, organized in 15 domains, into the Delphi survey. Two-hundred eighteen of 251 invitees (87%) provided responses (203 complete responses) for round 1 and 118 of 218 (42%) completed round2. Sixteen experts participated in the development meetings. The final outcome set includes 15 outcomes: 10 outcomes apply to all abortion trials (successful abortion, ongoing pregnancy, death, hemorrhage, uterine infection, hospitalization, surgical intervention, pain, gastrointestinal symptoms, and patients’ experience of abortion); 2 outcomes apply to only surgical abortion trials (uterine perforation and cervical injury), one applies only to medical abortion trials (uterine rupture); and 2 apply to trials evaluating abortions with anesthesia (over-sedation/respiratory depression and local anesthetic systemic toxicity). Conclusion Using robust consensus science methods we have developed a core outcome set for future abortion research. Implications Standardized outcomes in abortion research could decrease heterogeneity among trials and improve the quality of systematic reviews and clinical guidelines. Researchers should select, collect, and report these core outcomes in future abortion trials. Journal editors should advocate for core outcome set reporting.

A modified Delphi study was conducted to (1) identify intervention elements that are considered by geriatricians to be important in optimizing prescribing for older adults with multimorbidity, and (2) to select the accompanying behavior change techniques to be incorporated into a context-relevant intervention to support prescribing. Intervention elements such as medication review identified by the Delphi panel mirrored results from a previous scoping review. Statements involving roles of pharmacists selected by the panel validated findings in the literature that pharmacists play important collaborative roles to help reduce potentially inappropriate prescribing among older adults with multimorbidity. We identified relevant intervention elements and their accompanying behavior change techniques to aid in the development of a context-specific intervention. Potentially inappropriate prescribing among older adults is a rising concern, attributed mainly by polypharmacy and multimorbidity. We aimed to identify key components and strategies for construction of a context-relevant intervention to facilitate appropriate prescribing in outpatient clinics in Singapore. The modified Delphi study was conducted in two rounds with 20 geriatricians from seven public hospitals in Singapore. Round one survey presented 69 statements formulated from a scoping review, while round two presented 23 statements with some modifications based on round one comments. The statements were rated against a 7-point Likert scale on their importance and impact on prescribing for older adults with multimorbidty. Consensus were achieved for 90% of the statements. Seven intervention elements were identified as being important: medication review, training, medication therapy management, shared decision making, patient interview, medication reconciliation, comprehensive geriatric assessment. In addition, some commonly identified behavior change techniques included goal setting (behavior), goal setting (outcome) and problem solving. This study identified important intervention elements and their potential strategies that could be adopted in an intervention to optimize appropriate prescribing for older adults with multimorbidity.

PURPOSE To develop expert consensus on referral criteria for low vision services in Australia. METHODS In a modified online Delphi process, a panel of 38 Australian experts in low vision (including ophthalmologists, optometrists, orthoptists, occupational therapists, orientation and mobility professionals, researchers and managers) participated in three rounds of consensus building over a period of 5 months commencing in 2019. Initially, 90 statements were developed, addressing what should be included in best-practice low vision referral criteria, currently used criteria, timing of referral and responsibility for referral. By the third round, these had been reduced and refined to a total of four statements. RESULTS In three Delphi rounds, the expert panel produced three key recommendations for low vision referral: (1) that low vision referral should be based mainly on the impact of uncorrectable vision impairment on function and well-being; (2) clinical measures of visual acuity and visual field might be a secondary consideration and (3) it is important to fully inform a person about low vision services at an early stage of vision loss and to involve them in decision making about referral. There was consensus on the need for clear referral pathways and that both ophthalmologists and optometrists have primary responsibility to refer for low vision services. CONCLUSIONS Although recommendations and guidelines should not replace sound individual clinical judgement, promotion and adoption of these consensus recommendations could assist health care professionals in providing appropriate and timely referral for low vision services to the benefit of people with vision impairment.

Objective Selective fetal growth restriction (sFGR) complicating twin to twin transfusion syndrome (TTTS) is associated with 3 to 6 fold increased risk of fetal demise after fetoscopic laser surgery (FLS). Identifying these patients is challenging due to varying definitions used in the literature. Our objective was to determine the association of three currently used definitions for sFGR with demise of the smaller twin, typically the donor, following FLS METHODS: Retrospective cohort of monochorionic diamniotic pregnancies undergoing FLS for TTTS between January 2015 to December 2018. The entire cohort was classified as sFGR and non sFGR using 3 different criteria: 1- International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) as estimated fetal weight (EFW) of either twin 25% (Group A); 2- Delphi methods, EFW of either twin 95th centile (Group C). Pearson chi square, univariate and multivariate logistic regression analyses were performed. Results One hundred and twenty four patients underwent FLS between January 2015 and December 2018 for TTTS. 46/124 (37.1%) cases were identified as sFGR by ISUOG criteria (Group A), 57/124 (46%) cases were identified based on EFW Conclusions Fetal demise following FLS is increased in the presence of sFGR. Improving diagnosis of sFGR, will improve counseling and may affect management. Delphi method of defining sFGR based on presence of 2 of the 4 criteria had the highest predictive value of donor demise following FLS. This article is protected by copyright. All rights reserved.

Background Fasting during Ramadan is one of the five pillars of the Muslim faith. Despite the positive effects of fasting on health, there are no guidelines or clear recommendations regarding fasting after metabolic/bariatric surgery (MBS). The current study reports the result of a modified Delphi consensus among expert metabolic/bariatric surgeons with experience in managing patients who fast after MBS. Methods A committee of 61 well-known metabolic and bariatric surgeons from 24 countries was created to participate in the Delphi consensus. The committee voted on 45 statements regarding recommendations and controversies around fasting after MBS. An agreement/disagreement ≥ of 70.0% was regarded as consensus. Results The experts reached a consensus on 40 out of 45 statements after two rounds of voting. One hundred percent of the experts believed that fasting needs special nutritional support in patients who underwent MBS. The decision regarding fasting must be coordinated among the surgeon, the nutritionist and the patient. At any time after MBS, 96.7% advised stopping fasting in the presence of persistent symptoms of intolerance. Seventy percent of the experts recommended delaying fasting after MBS for 6 to 12 months after combined and malabsorptive procedures according to the patient's situation and surgeon's experience, and 90.1% felt that proton pump inhibitors should be continued in patients who start fasting less than 6 months after MBS. There was consensus that fasting may help in weight loss, improvement/remission of non-alcoholic fatty liver disease, dyslipidemia, hypertension and type 2 diabetes mellitus among 88.5%, 90.2%, 88.5%, 85.2% and 85.2% of experts, respectively. Conclusion Experts voted and reached a consensus on 40 statements covering various aspects of fasting after MBS.

Background and objectives: Documenting patient data in psoriasis clinical practice can improve care, but standardized and transparent documentation is rare. The current project aimed to develop a data set for the documentation of psoriasis in daily practice. Material and methods: In four online Delphi rounds and one in-person meeting, 27 psoriasis experts allocated variables to a standard, an optimal and an optional data set. Most of the questions were standardized. Open questions were included to allow for the provision of reasons and to enlarge the data sets. Furthermore, in the in-person meeting we considered a) patients' attitudes and b) dermatologists' information on the current usage and acceptability in Germany. Results: The consensus approach resulted in a data set with 69 variables. The standard data set includes 20, the optimal data set 31 and the optional data set 18 variables. In summary, the data set can mainly be grouped into master data, general status and medical history data, medical history of psoriasis, status of psoriasis, diagnostics and comorbidity, therapies and patient-reported outcomes. Conclusions: The consensus recommendation of a standard, an optimal and an optional data set for routine care of psoriasis intends to be a decision-making aid and an orientation for both daily practice and further development of documentation systems.

Context Hospice and palliative medicine (HPM) physicians frequently care for patients with substance use disorders (SUDs), but there is no consensus on which primary addiction medicine (AM) skills are essential. Objectives Identify key primary AM skills that physicians should acquire during an ACGME-accredited HPM fellowship program. Methods A modified Delphi study consisting of 18 experts on SUD in HPM and medical education. A literature review and expert input identified initial AM skills. In three Delphi rounds, participants rated each skill on a nine-point scale from “not at all important to include” to “crucial to include.” We calculated medians (IQRs), analyzed panelists’ comments, and grouped skills using the RAND / UCLA appropriateness method. Results Among 62 proposed AM skills, 53 skills were rated as appropriate to include (38 of which achieved agreement), and nine skills were rated as uncertain. AM skills most relevant to HPM included 1) defining chemical coping, median 8.5 (IQR 2); 2) balancing life expectancy with risks of opioid use for patients with SUD, 9 (IQR 0); 3) explaining best practices to dispose unused opioids postmortem, 8 (IQR 2); 4) managing pain for hospice patients with SUD, 9 (IQR 0.75); and 5) partnering with hospice to manage patients on methadone and buprenorphine, 9 (IQR 2). Experts did not achieve consensus on whether HPM physicians should be encouraged to learn to prescribe buprenorphine for patients with opioid use disorder, 6 (IQR 3). Conclusion HPM fellowships should consider incorporating the primary AM skills identified in this study in their curricula.

Background Abdominal wall hernia repair is one of the most commonly performed surgical procedures worldwide, yet despite this, there remains a lack of high-quality evidence to support best management. The aim of the study was to use a modified Delphi process to determine future research priorities in this field. Methods Stakeholders were invited by email, using British Hernia Society membership details or Twitter, to submit individual research questions via an online survey. In addition, questions obtained from a patient focus group (PFG) were collated to form Phase I. Two rounds of prioritization by stakeholders (phases II and III) were then completed to determine a final list of research questions. All questions were analyzed on an anonymized basis. Results A total of 266 questions, 19 from the PFG, were submitted by 113 stakeholders in Phase I. Of these, 64 questions were taken forward for prioritization in Phase II, which was completed by 107 stakeholders. Following Phase II analysis, 97 stakeholders prioritized 36 questions in Phase III. This resulted in a final list of 14 research questions, 3 of which were from the PFG. Stakeholders included patients and healthcare professionals (consultant surgeons, trainee surgeons and other multidisciplinary members) from over 27 countries during the 3 phases. Conclusion The study has identified 14 key research priorities pertaining to abdominal wall hernia surgery. Uniquely, these priorities have been determined from participation by both healthcare professionals and patients. These priorities should now be addressed by well-designed, high-quality international collaborative research.

Background Focal Therapy (FT) for Prostate Cancer (PCa) is promising. However, long-term oncological results are awaited and there is no consensus on follow-up strategies. Molecular biomarkers (MB) may be useful in selecting, treating and following up men undergoing FT, though there is limited evidence in this field to guide practice. We aimed to conduct a consensus meeting, endorsed by the Focal Therapy Society, amongst a large group of experts, to understand the potential utility of MB in FT for localised PCa. Materials and methods A 38-item questionnaire was built following a literature search. The authors then performed three rounds of a Delphi Consensus using DelphiManager, using the GRADE grid scoring system, followed by a face-to-face expert meeting. Three areas of interest were identified and covered concerning MB for FT, i) the current/present role; ii) the potential/future role; iii) the recommended features for future studies. Consensus was defined using a 70% agreement threshold. Results Of 95 invited experts, 42 (44.2%) completed the three Delphi rounds. Twenty-four items reached a consensus and they were then approved at the meeting involving (n=15) experts. Fourteen items reached a consensus on uncertainty, or they did not reach a consensus. They were re-discussed, resulting in a consensus (n=3), a consensus on a partial agreement (n=1), and a consensus on uncertainty (n=10). A final list of statements were derived from the approved and discussed items, with the addition of three generated statements, to provide guidance regarding MB in the context of FT for localised PCa. Research efforts in this field should be considered a priority. Conclusions The present study detailed an initial consensus on the use of MB in FT for PCa. This is until evidence becomes available on the subject.

Background Despite a substantial burden of musculoskeletal injury, orthopaedic trauma studies in Latin America are lacking. The purpose of the present study was to identify research priorities among orthopaedic trauma surgeons in Latin America. Methods Research questions were solicited from members of the Asociacion de Cirujanos Traumatologos de las Americas. Participants rated questions by importance from 1 to 9. All questions were redistributed with an aggregate rating, and participants rerated questions with knowledge of group responses. Results Seventy-eight participants completed the first survey and were included in subsequent surveys. The mean age was 51.8 years, and most participants were male (92%), had completed an orthopaedic trauma fellowship (60.3%), and participated in research (80.8%). Seventeen countries were represented; 5 respondents were from a high-income country, 67 were from an upper middle-income country, and 6 were from a lower middle-income country. Sixty-five questions were identified. Six questions were rated from 1 to 3 ("more important") by >70% of participants: (1) What is the optimal treatment protocol for elderly patients with hip fracture? (2) What is the most effective initial and definitive management of musculoskeletal injury, including timing and surgical strategy, for the polytraumatized patient? (3) What is the ideal state of open fracture treatment, including timeliness and method of antibiotics, debridement, surgical fixation, and closure or coverage, at each hospital level in the health-care system? (4) What patient and fracture characteristics predict infection after musculoskeletal injury? (5) What is the current state of treatment for fracture-related infection, including timeliness and method of antibiotics and surgical intervention, at each hospital level in the health-care system? (6) What is the optimal protocol for temporary management for the hemodynamically unstable patient with a pelvic or acetabular fracture? Conclusions This modified Delphi study of orthopaedic trauma surgeons in Latin America identified geriatric hip fractures, polytrauma, open fractures, musculoskeletal infection, and pelvic and acetabular fractures as top research priorities. This information is important for resource allocation and goal setting for orthopaedic trauma in the region.

Purpose Clinical trials have demonstrated that standardized voice treatment programs are effective for some patients, but identifying the unique individual treatment ingredients specifically responsible for observed improvements remains elusive. To address this problem, the authors used a taxonomy of voice therapy, the Rehabilitation Treatment Specification System (RTSS), and a Delphi process to develop the RTSS-Voice (expert consensus categories of measurable and unique voice treatment ingredients and targets). Method Initial targets and ingredients were derived from a taxonomy of voice therapy. Through six Delphi Rounds, 10 vocal rehabilitation experts rated the measurability and uniqueness of individual treatment targets and ingredients. After each round, revisions (guided by the experts' feedback) were finalized among a primary reader (a voice therapy expert) and two external readers (rehabilitation experts outside the field of voice). Consensus was established when the label and definition of an ingredient or target reached a supramajority threshold (≥ 8 of 10 expert agreement). Results Thirty-five target and 19 ingredient categories were agreed to be measurable, unique, and accurate reflections of the rules and terminology of the RTSS. Operational definitions for each category included differences in the way ingredients are delivered and the way individual targets are modified by those ingredients. Conclusions The consensus labels and operationalized ingredients and targets making up the RTSS-Voice have potential to improve voice therapy research, practice, and education/training. The methods used to develop these lists may be useful for other speech, language, and hearing treatment specifications. Supplemental Material https://doi.org/10.23641/asha.15243357

BACKGROUND Social participation has been incorporated by occupational therapists in Brazil, and worldwide, as a professional concept to guide practice. The concept has been studied, defined, and constructed from multiple fields of knowledge and can be defined as the social and political involvement of people in social groups and /or public and community spaces. There are different understandings of social participation in occupational therapy and the objective of this study was to explore how Brazilian occupational therapists define social participation in their fields of knowledge. METHOD Through application of the Delphi technique, Brazilian occupational therapy academics and professionals who have worked in the state of Sao Paulo, Brazil, collaboratively responded to an online questionnaire. In the consultation phase, occupational therapists wrote their conceptions about social participation and, in the consensus phase, expressed their opinions and judgements, in order to, in a collective construction, establish a consensus on the definition of social participation. RESULTS In the first round of the consensus phase, 38 academics and 27 professionals participated and in the second round, 20 and 14, respectively. Results were analysed quantitatively, through the establishment of degrees of agreement for conceptions arranged in statements. Then, six categories of analysis were built, which identified the multiple ways of understanding social participation: social participation and social interactions, social participation and freedom of movement, social participation as an experience in public and political life, social participation and human activities, social participation and the process of social inclusion, and social participation in the fields of knowledge and practice in occupational therapy. CONCLUSION There are theoretical-conceptual differences in the understandings and uses of social participation in occupational therapy that delimit specificity and design the identities of the profession in society. The need to discuss knowledge production, accumulation, and dissemination and practices is debated.

Introduction Occupation-centred practice is key to aligning with the contemporary paradigm. Benefits of this approach for clients and the profession are well documented, yet how to identify occupation-centred practice is not yet understood. Therefore, this study aimed to uncover the characteristics of occupation-centred practice and how they can be identified in practice. Methods A three round Delphi survey was conducted to gain consensus on the defining characteristics of occupation-centred practice. Purposive, convenience, and snowball sampling were used to distribute three survey rounds to occupational therapists internationally. Content analysis was used to create characteristics, descriptions, and examples of occupation-centred practice. Percentage agreement between occupational therapists were calculated to determine consensus. Results Responses were received from 100 participants in round one, 89 in round two, and 70 in round three. Round one generated 12 characteristics that were refined and finalised into four defining characteristics, one of which had three subcharacteristics. The four characteristics are as follows: guided by theory and philosophy grounded in occupation, language and documentation promotes occupation among stakeholders, understanding and incorporating the person's context, and occupation as core to practice, which includes occupation in goal setting, assessment, and intervention. Descriptions and examples were generated for each characteristic. Conclusion This study presents valuable information for occupational therapists wanting to practise in an occupation-centred manner. The characteristics, descriptions, and examples provide a foundation upon which occupational therapists can understand and identify occupation-centred practice. Examples provided were highly influenced by factors including practice settings and preferred terminology. Future research will explore the creation of a tool for occupational therapists to evaluate their own practice against the characteristics to demonstrate areas of strength and for development.

Lumbar spinal stenosis (LSS) causing neurogenic claudication (NC) is increasingly common with an aging population and can be associated with significant symptoms and functional limitations. We developed this guideline to present the evidence and provide clinical recommendations on nonsurgical management of patients with LSS causing NC. Using the GRADE approach, a multidisciplinary guidelines panel based recommendations on evidence from a systematic review of randomized controlled trials and systematic reviews published through June 2019, or expert consensus. The literature monitored up to October 2020. Clinical outcomes evaluated included pain, disability, quality of life, and walking capacity. The target audience for this guideline includes all clinicians, and the target patient population includes adults with LSS (congenital and/or acquired, lateral recess or central canal, with or without low back pain, with or without spondylolisthesis) causing NC. The guidelines panel developed 6 recommendations based on randomized controlled trials and 5 others based on professional consensus, summarized in 3 overarching recommendations: (Grade: statements are all conditional/weak recommendations) Recommendation 1. For patients with LSS causing NC, clinicians and patients may initially select multimodal care nonpharmacological therapies with education, advice and lifestyle changes, behavioral change techniques in conjunction with home exercise, manual therapy, and/or rehabilitation (moderate-quality evidence), traditional acupuncture on a trial basis (very low-quality evidence), and postoperative rehabilitation (supervised program of exercises and/or educational materials encouraging activity) with cognitive-behavioral therapy 12 weeks postsurgery (low-quality evidence). Recommendation 2. In patients LSS causing NC, clinicians and patients may consider a trial of serotonin–norepinephrine reuptake inhibitors or tricyclic antidepressants. (very low-quality evidence). Recommendation 3. For patients LSS causing NC, we recommend against the use of the following pharmacological therapies: nonsteroidal anti-inflammatory drugs, methylcobalamin, calcitonin, paracetamol, opioids, muscle relaxants, pregabalin (consensus-based), gabapentin (very low-quality), and epidural steroidal injections (high-quality evidence). Perspective This guideline, on the basis of a systematic review of the evidence on the nonsurgical management of lumbar spine stenosis, provides recommendations developed by a multidisciplinary expert panel. Safe and effective non-surgical management of lumbar spine stenosis should be on the basis of a plan of care tailored to the individual and the type of treatment involved, and multimodal care is recommended in most situations.

Background Video-assisted thoracoscopic surgery (VATS) is a minimally invasive approach for the treatment of lung cancer and other lung diseases. Although VATS is associated with better outcomes compared with open surgery, the extensive skill and knowledge requirements may prolong the learning curve and limit adoption. Objective The objective of this work was to develop a training model that optimizes skill acquisition while shortening the learning curve of novel surgical procedures, with a specific application to VATS training. Methods A seven-step training method was developed. A board of thoracic surgeons was then surveyed by a Delphi process to validate the method within the context of a VATS curriculum. Results The Delphi consensus established the following: 1) there is a need for a standardized, stepwise training approach for VATS lobectomy; 2) the seven-step method can be locally adapted and applied to VATS training and maximizes the chances of success for both the individual and the institution; 3) the framework is universal and can be adapted for other novel devices and procedures; 4) the model covers the elements needed to make it safe and provide good outcomes for patients; and 5) the training method has the necessary requirements to be established as standard practice. Conclusion This paper presents the educational components that are needed to form a standardized curriculum for VATS, as agreed by a panel of established thoracic surgeons through a Delphi process. The training framework considers both individual and team-specific skills along the learning curve to optimize outcomes for patients.

Aim To identify the highest-priority clinical research areas related to children with neurological impairment and medical complexity among clinicians and caregivers. Method A modified, three-stage Delphi study using online surveys and guided by a steering committee was completed. In round 1, clinicians and family caregivers suggested clinical topics and related questions that require research to support this subgroup of children. After refinement of the suggestions by the steering committee, participants contributed to 1 (family caregivers) or 2 (clinicians) subsequent rounds to develop a prioritized list. Results A diverse international expert panel consisting of 49 clinicians and 12 family caregivers provided 601 responses. Responses were distilled into 26 clinical topics comprising 126 related questions. The top clinical topics prioritized for research were irritability and pain, child mental health, disorders of tone, polypharmacy, sleep, aspiration, behavior, dysautonomia, and feeding intolerance. The clinician expert panel also prioritized 10 specific research questions. Interpretation Study findings support a research agenda for children with neurological impairment and medical complexity focused on addressing clinical questions, prioritized by an international group of clinicians and caregivers.

Purpose The availability of psychosocial support measures has a significant impact on the quality of life of terminally ill and dying patients and the burden experienced by their relatives. To date, no intervention has specifically focused on promoting interaction within the dyads of the following: (1) terminally ill adult children and their parents and (2) terminally ill parents and their adult children. A national Delphi study was conducted to provide appropriate recommendations for dyadic psychosocial support measures. Methods Recommendations were formulated from qualitative interview data on the experiences and wishes of patients and family caregivers within these two dyads. Experts from palliative and hospice care providers rated the relevance and feasibility of 21 recommendations on two 4-point Likert-type scales, respectively. Additional suggestions for improvement were captured via free text fields. Individual items were considered consented when ≥ 80% of participants scored 1 (strongly agree) or 2 (somewhat agree) regarding both relevance and feasibility. Results A total of 27 experts (35% response rate) completed two Delphi rounds. Following the first round, 13 recommendations were adjusted according to participants’ comments. After the second round, consensus was achieved for all 21 of the initially presented recommendations. Conclusion The Delphi-consented recommendations for parents and adult children at the end of life provide the first guidance for hands-on dyadic psychosocial support measures for parent–adult child relationships, specifically. The next step could involve the structured implementation of the recommendations, accompanied by scientific research. This study was registered on October 27, 2017, with the German Clinical Trials Register (DRKS00013206).

Objective The association between low-grade systemic inflammation and musculoskeletal pain may be influenced by multiple factors. However, little is known about the relative importance of these factors, and few studies account for them. This Delphi study aimed to reach consensus on the most important confounders which influence the association between low-grade systemic inflammation and musculoskeletal pain. Methods The panel consisted of 48 experts. In Round 1, the experts proposed what they believed were important confounders. In Round 2, the experts indicated for each confounder whether they believed it was important (yes/no). At least 50% of experts had to indicate the confounder was important to be considered in the final round. In Round 3, the experts rated the importance of each confounder on a 7-point Likert scale. Consensus was reached if ≥75% of the experts considered the factor either extremely or moderately important. Results In Round 1, 120 confounders were proposed, which were synthesized into 38 distinct factors. In Round 2, 33 confounders met the criterion to be considered important. In Round 3, consensus was reached for 14 confounders: acute illness/trauma, immune disease, medication use, endocrine, nutritional, or metabolic disease, other musculoskeletal conditions, age, handling of blood samples, sex, cancer, body composition, pregnancy, cardiovascular disease, physical activity, and pain characteristics. Conclusions These findings provide insight in the complexity of the association between low-grade systemic inflammation and musculoskeletal pain. Some factors currently listed as confounders may be re-classified as moderators or mediators as insights progress.

Background A venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines. Aim The aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration. Methods Through a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports.

Background Cerebrotendinous xanthomatosis (CTX) is a rare, chronic, progressive, neurodegenerative disorder requiring life-long care. Patients with CTX often experience a diagnostic delay. Although early diagnosis and treatment initiation can improve symptoms and prognosis, a standardised approach to diagnosis, treatment and management of patients is not yet established. Aim To assess expert opinion on best care practices for patients with CTX using a modified Delphi method. Methods A multidisciplinary group of healthcare professionals with expertise in CTX responded to a 3-round online questionnaire (n = 10 in Rounds 1 and 2; n = 9 in Round 3), containing questions relating to the diagnosis, treatment, monitoring, multidisciplinary care and prognosis of patients with CTX. Determination of consensus achievement was based on a pre-defined statistical threshold of ≥ 70% Delphi panellists selecting 1–2 (disagreement) or 5–6 (agreement) for 6-point Likert scale questions, or ≥ 70% Delphi panellists choosing the same option for ranking and proportion questions. Results Of the Round 1 (n = 22), Round 2 (n = 32) and Round 3 (n = 26) questions for which consensus was assessed, 59.1%, 21.9% and 3.8% reached consensus, respectively. Consensus agreement that genetic analyses and/or determination of serum cholestanol levels should be used to diagnose CTX, and dried bloodspot testing should facilitate detection in newborns, was reached. Age at diagnosis and early treatment initiation (at birth, where possible) were considered to have the biggest impact on treatment outcomes. All panellists agreed that chenodeoxycholic acid (CDCA) is a lifetime replacement therapy which, if initiated early, can considerably improve prognosis as it may be capable of reversing the pathophysiological process in CTX. No consensus was reached on the value of cholic acid therapy alone. Monitoring patients through testing plasma cholestanol levels and neurologic examination was recommended, although further research regarding monitoring treatment and progression of the disease is required. Neurologists and paediatricians/metabolic specialists were highlighted as key clinicians that should be included in the multidisciplinary team involved in patients’ care. Conclusions The results of this study provide a basis for standardisation of care and highlight key areas where further research is needed to inform best practices for the diagnosis, treatment and management of patients with CTX.

This Practice Advisory presents a comprehensive and evidence-based set of position statements and recommendations for the use of contrast media in interventional pain procedures. The advisory was established by an international panel of experts under the auspices of 11 multinational and multispecialty organizations based on a comprehensive review of the literature up to December 31, 2019. The advisory discusses the risks of using gadolinium-based contrast agents. These include nephrogenic systemic fibrosis, gadolinium brain deposition/retention, and encephalopathy and death after an unintentional intrathecal gadolinium injection. The advisory provides recommendations on the selection of a specific gadolinium-based contrast agent in patients with renal insufficiency, those who had multiple gadolinium-enhanced magnetic resonance imaging examinations, and in cases of paraspinal injections. Additionally, recommendations are made for patients who have a history of mild, moderate, or severe hypersensitivity reactions to contrast medium.

Background Studies evaluating the efficacy of ATLS in low- and middle-income countries are limited. We followed up ATLS providers certified by the ATLS India program over a decade (2009 to 2019), aiming to measure the benefits in knowledge, skills, attitude and their attrition over time. Methods The survey instrument was developed taking a cue from published literature on ATLS and improvised using the Delphi method. Randomly selected ATLS providers were sent the survey instrument via email as a Google form, along with a statement of purpose. Results are presented descriptively. Results ATLS India trained 7,847 providers over the study period. 2500 providers were selected for the survery using computer-generated random number table. One thousand and thirty doctors (41.2%) responded. Improvement in knowledge (n = 1,013 [98.3%]), psychomotor skills (n = 986 [95.7%]), organizational skills (n = 998 [96.9%]), overall trauma management (n = 1,013 [98.7%]) and self-confidence (n = 939 [91%]) were reported. Majority (904 [87.8%]) started ATLS promulgation at workplace in personal capacity. These benefits lasted beyond 2 years in majority (>60%) of respondents. More than 40% reported cognitive (n = 492 [47.8%]), psychomotor (n = 433 [42%]), and organizational benefits (n = 499 [48.4%]) lasting beyond 3 years. Improvement in self-confidence, ATLS promulgation at the workplace, and retention of organizational skills were more pronounced in ATLS faculties than providers. All other benefits were found to be comparable in both sub-groups. Lack of trained staff (n = 660 [64.1%]) and attitude issues (n = 495 [48.1%]) were the major impediments in implementing ATLS at the workplace. More than a third of respondents (n = 373 [36.2%]) could enumerate one or more incidents where ATLS principles were life- or limb- saving. Conclusions Cognitive, psychomotor, organizational, and affective impact of ATLS is overwhelmingly positive in the Indian scenario. Until formal trauma systems are established, ATLS remains the best hope for critically injured patients in resource-contrained settings.

Background: Medium, large and giant congenital melanocytic naevi (CMN) can impose a psychosocial burden on patients and families, and are associated with increased risk of developing melanoma or neurological symptoms. Lack of consensus on what outcomes to measure makes it difficult to advise patients and families about treatment and to set up best practice for CMN. Objectives: Fostering consensus among patient representatives and professionals, we aim to develop a core outcome set, defined as the minimum set of outcomes to measure and report in care and all clinical trials of a specific health condition. We focused on the ‘what to measure’ aspect, the so-called core domain set (CDS), following the COMET and CS-COUSIN guidelines. Methods: We conducted a systematic review to identify outcomes reported in the literature. Focus groups with patient representatives identified patient-reported outcomes. All these outcomes were classified into domains. Through e-Delphi surveys, 144 stakeholders from 27 countries iteratively rated the importance of domains and outcomes. An online consensus meeting attended by seven patient representatives and seven professionals finalized the CDS. Results: We reached consensus on six domains, four of which were applied to both care and research: ‘quality of life’, ‘neoplasms’, ‘nervous system’ and ‘anatomy of skin’. ‘Adverse events’ was specific to care and ‘pathology’ to research. Conclusions: We have developed a CDS for medium-to-giant CMN. Its application in reporting care and research of CMN will facilitate treatment comparisons. The next step will be to reach consensus on the specific outcomes for each of the domains and what instruments should be used to measure these domains and outcomes.

Background: Spinal Muscular Atrophy (SMA) is a rare disease that affects 1 in 11 000 live births. Recent developments in SMA treatments have included new disease-modifying therapies that require high quality data to inform decisions around initiation and continuation of therapy. In Canada, there are no nationally agreed upon outcome measures (OM) used in adult SMA. Standardization of OM is essential to obtain high quality data that is comparable among neuromuscular clinics. Objective: To develop a recommended toolkit and timing of OM for assessment of adults with SMA. Methods: A modified delphi method consisting of 2 virtual voting rounds followed by a virtual conference was utilized with a panel of expert clinicians treating adult SMA across Canada. Results: A consensus-derived toolkit of 8 OM was developed across three domains of function, with an additional 3 optional measures. Optimal assessment frequency is 12 months for most patients regardless of therapeutic access, while patients in their first year of receiving disease-modifying therapy should be assessed more frequently. Conclusions: The implementation of the consensus-derived OM toolkit will improve monitoring and assessment of adult SMA patients, and enrich the quality of real-world evidence. Regular updates to the toolkit must be considered as new evidence becomes available.

Background In 2010, 240 billion US dollars was invested worldwide to conduct research for health; unfortunately, 200 billion was misused in the production and reporting of the evidence researched. Universities could facilitate students to acquire leadership competencies to move well-conducted research findings into practical use; this could be an essential move to reduce the misuse of investment. Methods A literature review was done based on the Equator Network and Cochrane guidelines, followed by three Delphi rounds to select competencies. Results Eleven papers were analysed out of 1121 items and 39/78 identified competencies were prioritized to be presented in the Delphi. Four out of 12 participants accepted to be involved in this project, and 22 competencies reached consensus and stability after three rounds. This framework conceptualizes competencies as the knowledge, skills, attitudes and values. The competencies were framed in four domains: knowledge management, engage diverse others in public health initiatives, training and capacity building/change management and communication. Conclusion This framework offers guidance to universities when instructing students with leadership competencies for KT. This project emphasizes that effective leadership should include personal conscience and self-determination values.

[No Abstract Available], Bayer, The Delphi panel meeting from which this publication was derived was supported by Bayer.

Background and Aims Diagnosis and management of inflammatory bowel diseases [IBD] requires a lifelong multidisciplinary approach. The quality of medical reporting is crucial in this context. The present topical review addresses the need for optimised reporting in endoscopy, surgery, and histopathology. Methods A consensus expert panel consisting of gastroenterologists, surgeons, and pathologists, convened by the European Crohn’s and Colitis Organisation, performed a systematic literature review. The following topics were covered: in endoscopy: [i] general IBD endoscopy; [ii] disease activity and surveillance; [iii] endoscopy treatment in IBD; in surgery: [iv] medical history with surgical relevance, surgical indication, and strategy; [v] operative approach; [vi] intraoperative disease description; [vii] operative steps; in pathology: [viii] macroscopic assessment and interpretation of resection specimens; [ix] IBD histology, including biopsies, surgical resections, and neoplasia; [x] IBD histology conclusion and report. Statements were developed using a Delphi methodology incorporating two consecutive rounds. Current practice positions were set when ≥ 80% of participants agreed on a recommendation. Results Thirty practice positions established a standard terminology for optimal reporting in endoscopy, surgery, and histopathology. Assessment of disease activity, surveillance recommendations, advice to surgeons for operative indication and strategies, including margins and extent of resection, and diagnostic criteria of IBD, as well as guidance for the interpretation of dysplasia and cancer, were handled. A standardised report including a core set of items to include in each specialty report, was defined. Conclusions Interdisciplinary high-quality care requires thorough and standardised reporting across specialties. This topical review offers an actionable framework and practice recommendations to optimise reporting in endoscopy, surgery, and histopathology.

BackgroundAnkle fracture is a common injury with a strong evidence base focused on effectiveness of treatments. However, there are no reporting guidelines on distal tibia and ankle fractures. This has led to heterogeneity in outcome reporting and consequently, restricted the contribution of evidence syntheses. Over the past decade, core outcome sets have been developed to address this issue and are available for several common fractures, including those of the hip, distal radius, and open tibial fractures. This protocol describes the process to co-produce—with patient partners and other key stakeholders—a multi-stakeholder derived Core Outcome Set for distal Tibia and Ankle fractures (COSTA). The scope of COSTA will be for clinical trials.MethodsThe study will have five-stages which will include the following: (i) systematic reviews of existing qualitative studies and outcome reporting in randomised controlled trial studies to inform a developing list of potential outcome domains; (ii) qualitative interviews (including secondary data) and focus groups with patients and healthcare professionals to explore the impact of ankle fracture and the outcomes that really matter; (iii) generation of meaningful outcome statements with the study team, international advisory group and patient partners; (iv) a multi-round, international e-Delphi study to achieve consensus on the core domain set; and (v) an evidence-based consensus on a core measurement set will be achieved through a structured group consensus meeting, recommending best assessment approaches for each of the domains in the core domain set.DiscussionDevelopment of COSTA will provide internationally endorsed outcome assessment guidance for clinical trials for distal tibia and ankle fractures. This will enhance comparative reviews of interventions, potentially reducing reporting bias and research waste.

Introduction The COVID-19 pandemic is having an impact on multiple levels, one being the way of providing mental health care services. A study was proposed in order to identify the standpoints regarding the role we must assume as psychiatrists in the setting of this pandemic in Colombia. Methods A study was developed employing a Delphi-type methodology. Three types of psychiatrist were included for the application of the instrument: directors of academic psychiatry programmes, directors of mental health institutions and private practitioners. Results Responses were collected over the course of a month (between April and May) by 24 participants corresponding to 14 private practitioners (58.3%), 6 heads of academic programmes (25.1%) and 4 directors of mental health services (16.6%). The results, grouped around the psychiatric work, describe the impact generated by the pandemic and the possible role of the specialist. Conclusions Consistency was identified around the need to provide a differential approach according to the vulnerabilities of each group of people exposed to the pandemic; as well as the remote provision of health care through technology, often using videoconferencing.

Background Physical therapists provide treatment for pain and other common complaints for women in the postpartum period, thereby contributing to the improvement of their functioning. However, before applying any interventions, physical therapists should assess their patients to identify the desired therapeutic goals. In this context, the International Classification of Functioning, Disability and Health (ICF) may be a useful tool for documenting functioning data and operationalizing collaborative goal setting. Objective To identify ICF categories and the respective domains that should be considered in the evaluation of women postpartum. Methods A consensus-building, three-round e-mail survey was conducted using the Delphi method. The sample included Brazilian physical therapists with expertise in women’s health. Meaningful content was analyzed in accordance to the ICF linking rules. The kappa coefficient and content validity index (CVI) were calculated. Results The panel consisted of 45 participants with a median age of 33 years and more than 10 years of experience in women’s health. A total of 1261 meaningful contents were identified from the responses in the first round. After consensus was achieved, a final list of 62 items was prepared, including 53 categories (11 were on structures; 15 on body functions; 12 on activities and participation; 15 on environmental factors) and nine personal factors (CVI = 0.89). Conclusion From the perception of physical therapists, an ICF-based postpartum assessment to describe functioning and disability must comprise 53 ICF categories and nine personal factors.