International Expert Consensus on Semantics of Multimodal Esophageal Cancer Treatment: Delphi Study.

BACKGROUND: Recent developments in esophageal cancer treatment, including studies exploring active surveillance following chemoradiotherapy, have led to a need for clear terminology and definitions regarding different multimodal treatment options. OBJECTIVE: The aim of this study was to reach worldwide consensus on the definitions and semantics of multimodal esophageal cancer treatment. METHODS: In total, 72 experts working in the field of multimodal esophageal cancer treatment were invited to participate in this Delphi study. The study comprised three Delphi surveys sent out by email and one online meeting. Input for the Delphi survey consisted of terminology obtained from a systematic literature search. Participants were asked to respond to open questions and to indicate whether they agreed or disagreed with different statements. Consensus was reached when there was ≥75% agreement among respondents. RESULTS: Forty-nine of 72 invited experts (68.1%) participated in the first online Delphi survey, 45 (62.5%) in the second survey, 21 (46.7%) of 45 in the online meeting, and 39 (86.7%) of 45 in the final survey. Consensus on neoadjuvant and definitive chemoradiotherapy with or without surgery was reached for 27 of 31 items (87%). No consensus was reached on follow-up after treatment with definitive chemoradiotherapy. CONCLUSION(S): Consensus was reached on most statements regarding terminology and definitions of multimodal esophageal cancer treatment. Implementing uniform criteria facilitates comparison of studies and promotes international research collaborations.

REPAIRS Delphi: A UK and Ireland Consensus Statement on the Management of Infected Arterial Pseudoaneurysms Secondary to Groin Injecting Drug Use.

OBJECTIVE: Consensus guidelines on the optimal management of infected arterial pseudoaneurysms secondary to groin injecting drug use are lacking. This pathology is a problem in the UK and globally, yet operative management options remain contentious. This study was designed to establish consensus to promote better management of these patients, drawing on the expert experience of those in a location with a high prevalence of illicit drug use. METHODS: A three round modified Delphi was undertaken, systematically surveying consultant vascular surgeons in the UK and Ireland using an online platform. Seventy five vascular surgery units were invited to participate, with one consultant providing the unit consensus practice. Round one responses were thematically analysed to generate statements for round two. These statements were evaluated by participants using a five point Likert scale. Consensus was achieved at a threshold of 70% or more agreement or disagreement. Those statements not reaching consensus were assessed and modified for round three. The results of the Delphi process constituted the consensus statement. RESULTS: Round one received 64 (86%) responses, round two 59 (79%) responses, and round three 62 (83%) responses; 73 (97%) of 75 units contributed. Round two comprised 150 statements and round three 24 statements. Ninety one statements achieved consensus agreement and 15 consensus disagreement. The Delphi statements covered sequential management of these patients from diagnosis and imaging, antibiotics and microbiology, surgical approach, wound management, follow up, and additional considerations. Pre-operative imaging achieved consensus agreement (97%), with computed tomography angiography being the modality of choice (97%). Ligation and debridement without arterial reconstruction was the preferred approach at initial surgical intervention (89%). Multidisciplinary management, ensuring holistic care and access to substance use services, also gained consensus agreement. CONCLUSION: This comprehensive consensus statement provides a strong insight into the standard of care for these patients.

Establishing Outcome Parameters for Helicopter Emergency Medical Services Research in the Netherlands: Results of a Mixed-Methods Delphi Consensus Study.

OBJECTIVES: Physician staffed Helicopter Emergency Medical Services (P-HEMS) care in the Netherlands has transitioned from predominantly trauma management to handling a variety of medical conditions. Relevant outcome parameters for Dutch P-HEMS research have not been previously defined. National consensus was sought to identify relevant long term patient outcome parameters, process outcome parameters and performance outcome parameters for Dutch P-HEMS care. METHODS: This was a mixed methods Delphi consensus study. A list of potentially relevant outcome parameters was identified using a systematic literature review. These parameters were subsequently surveyed in a Delphi consensus study. Helicopter Emergency Medical Services physicians and relevant stakeholders were invited to participate in this Delphi survey, where they were allowed to suggest additional outcome parameters. Descriptive analysis was performed on all data sets. RESULTS: Forty-nine potential outcome parameters for Dutch P-HEMS care were surveyed. Of 71 invited participants, 53 (75%), 40 (56%), and 20 (28%) participated in the first, second, and third round of the Delphi study, respectively. Consensus was reached on 25 (51%) of 49 outcome parameters as being important. These consisted of seven long term patient related outcome parameters, four short term patient related outcome parameters, five process outcome parameters and nine performance outcome parameters. CONCLUSIONS: In conclusion, this study identified 25 outcome parameters relevant for Dutch physician staffed HEMS care. These parameters should be considered when designing future studies and should be routinely collected for each dispatch if possible.

Health literacy competency requirements for health professionals: a Delphi consensus study in Taiwan.

BACKGROUND: Cumulative evidence supports the importance of health literacy in determining the quality of healthcare delivery and outcomes. To enhance health literacy competencies among professionals and alleviate healthcare barriers owing to patients' inadequate health literacy, evidence-based health literacy competency guidelines are needed for the development of health professionals' training curricula. The aim of this study was to validate and refine a set of health literacy competencies, including knowledge, attitude, and skills of health professionals, and to prioritize the importance of health literacy practices among healthcare professionals. METHODS: We employed a consensus-building approach that utilized a modified three-round Delphi process conducted in 2017. An online Delphi panel was assembled, comprising 20 Taiwanese health literacy experts from diverse fields such as medicine, nursing, public health, language, and communication. A set of health literacy competencies previously identified and validated by an international panel of health literacy experts was cross-culturally translated. RESULTS: After three rounds of ratings and modifications, a consensus agreement was reached on 42 of 62 health literacy competencies, including 12 of 24 knowledge items, 9 of 11 attitude items, and 21 of 27 skill items. Of the 32 health literacy practices, "avoidance using medical jargon," "speaking slowly and clearly with patients," and "using analogies and examples" were deemed most important by the panelists. CONCLUSIONS: The Delphi panel's consensus helped to identify a set of core health literacy competencies that could serve as measurable learning objectives to guide the development of a health literacy curriculum for health professionals. The prioritized health literacy practices can be employed as indicators of health literacy competencies that health professionals should learn and routinely use in clinical settings.

An Eastern Europe and Middle East multinational expert Delphi consensus study on the prevention, diagnosis, and treatment of developmental dysplasia of the hip before walking age.

PURPOSE: The incidence of developmental dysplasia of the hip (DDH) is higher in Eastern Europeans and Middle Easterners. This study aimed to establish consensus among experts in this geographical area on the management of DDH before walking age. METHODS: Fourteen experienced orthopedic surgeons agreed to participate in a four-round online consensus panel by the Delphi method. The questionnaire included 31 statements concerning the prevention, diagnosis, and treatment of DDH before walking age. RESULTS: Consensus was established for 26 (84%) of 31 statements. Hip ultrasonography is the proper diagnostic tool under six months in DDH; universal newborn hip screening between three and six weeks is necessary; positive family history, breech presentation, female gender, and postnatal swaddling are the most important risk factors; Ortolani, Barlow tests, and limitation of abduction are the most important clinical findings; Pavlik harness is the first bracing preference; some Graf type IIa hips and all Graf type IIb and worse hips need abduction bracing treatment; the uppermost age limit for closed and open reductions is 12 months and 12-24 months, respectively; anatomic reduction is essential in closed and open reductions, postoperative MRI or CT is not always indicated; anterior approach open reduction is better than medial approach open reduction; forceful reduction and extreme positioning of the hips (> 60° hip abduction) are the two significant risk factors for osteonecrosis of the femoral head. CONCLUSION: The findings of the present study may be useful for clinicians because a practical reference, based on the opinions of the multinational expert panel, but may not be applicable to all settings is provided.

Diagnostic tests recommended for the clinical assessment of patients with wrist complaints, an e-Delphi study.

BACKGROUND: Evidence-based practice for history-taking and physical examination in the evaluation of wrist complaints is limited. PURPOSE: To create a set of recommended diagnostic tests for the clinical assessment of patients with undifferentiated wrist complaints. STUDY DESIGN: An e-Delphi study, following the recommendations on conducting and reporting Delphi studies, was performed. METHODS: In this e-Delphi study, a national multidisciplinary panel of experts was invited to inventory diagnostic tests, based on several case scenarios, for the probability diagnosis in patients (age ≥18 years) with undifferentiated wrist complaints. Four case scenarios were constructed and presented to the expert panel members, which differed in age of the patient (35 vs 65 years), location (radial vs ulnar), and duration (6 vs 10 weeks) of the complaints. In consecutive rounds, the experts were asked to rate the importance of the inventoried diagnostic tests. Finally, experts were asked to rank recommended diagnostic tests for each case scenario. RESULTS: Merging all results, the following diagnostic tests were recommended for all case scenarios: ask whether a trauma has occurred, ask how the complaints can be provoked, ask about the localization of the complaints, assess active ranges of motion, assess the presence of swelling, assess the difference in swelling between the left and right, assess the deformities or changes in position of the wrist, and palpate at the point of greatest pain. CONCLUSIONS: This is the first scientific study where experts clinicians recommended diagnostic tests when assessing patients with undifferentiated wrist complaints, varying in age of the patient (35 vs 65 years), location (radial vs ulnar), and duration (6 vs 10 weeks).

Interdisciplinary strategies to prevent long-term and detrimental opioid use following trauma: a stakeholder consensus study.

OBJECTIVE: Prolonged opioid use is common following traumatic injuries. Although preventive strategies have been recommended, the evidence supporting their use is low. The objectives of this study were to select interdisciplinary strategies to prevent long-term, detrimental opioid use in trauma patients for further evaluation and to identify implementation considerations. DESIGN: A consensus study using the nominal group technique. SETTING: Four trauma systems in Canada. SUBJECTS: Participants included expert clinicians and decision makers, and people with lived experience. METHODS: Participants had to discuss the relevance and implementation of 15 strategies and then rank them using a 7-point Likert scale. Implementation considerations were identified through a synthesis of discussions. RESULTS: A total of 41 expert stakeholders formed the nominal groups. Overall, eight strategies were favored: 1) using multimodal approach for pain management, 2) professional follow-up in physical health, 3) assessment of risk factors for opioid misuse, 4) physical stimulation, 5) downward adjustment of opioids based on patient recovery, 6) educational intervention for patients, 7) training offered to professionals on how to prescribe opioids, and 8) optimizing communication between professionals working in different settings. Discussions with expert stakeholders revealed the rationale for the selected strategies and identified issues to consider when implementing them. CONCLUSION: This stakeholder consensus study identified, for further scientific study, a set of interdisciplinary strategies to promote appropriate opioid use following traumatic injuries. These strategies could ultimately decrease the burden associated with long-term opioid use.

Clinical Response to Procedural Stroke Following Carotid Endarterectomy: A Delphi Consensus Study.

OBJECTIVE: No dedicated studies have been performed on the optimal management of patients with an acute stroke related to carotid intervention nor is there a solid recommendation given in the European Society for Vascular Surgery guideline. By implementation of an international expert Delphi panel, this study aimed to obtain expert consensus on the optimal management of in hospital stroke occurring during or following CEA and to provide a practical treatment decision tree. METHODS: A four round Delphi consensus study was performed including 31 experts. The aim of the first round was to investigate whether the conceptual model indicating the traditional division between intra- and post-procedural stroke in six phases was appropriate, and to identify relevant clinical responses during these six phases. In rounds 2, 3, and 4, the aim was to obtain consensus on the optimal response to stroke in each predefined setting. Consensus was reached in rounds 1, 3, and 4 when ≥ 70% of experts agreed on the preferred clinical response and in round 2 based on a Likert scale when a median of 7 - 9 (most adequate response) was given, IQR ≤ 2. RESULTS: The experts agreed (> 80%) on the use of the conceptual model. Stroke laterality and type of anaesthesia were included in the treatment algorithm. Consensus was reached in 17 of 21 scenarios (> 80%). Perform diagnostics first for a contralateral stroke in any phase, and for an ipsilateral stroke during cross clamping, or apparent stroke after leaving the operation room. For an ipsilateral stroke during the wake up phase, no formal consensus was achieved, but 65% of the experts would perform diagnostics first. A CT brain combined with a CTA or duplex ultrasound of the carotid arteries should be performed. For an ipsilateral intra-operative stroke after flow restoration, the carotid artery should be re-explored immediately (75%). CONCLUSION: In patients having a stroke following carotid endarterectomy, expedited diagnostics should be performed initially in most phases. In patients who experience an ipsilateral intra-operative stroke following carotid clamp release, immediate re-exploration of the index carotid artery is recommended.

Core outcome set for research studies evaluating treatments for twin-twin transfusion syndrome.

OBJECTIVE: To develop, using a Delphi procedure and a nominal group technique, a core outcome set (COS) for studies evaluating treatments for twin-twin transfusion syndrome (TTTS), which should assist in standardizing outcome selection, collection and reporting in future research studies. METHODS: An international steering group comprising healthcare professionals, researchers and patients with experience of TTTS guided the development of this COS. Potential core outcomes, identified through a comprehensive literature review and supplemented by outcomes suggested by the steering group, were entered into a three-round Delphi survey. Healthcare professionals, researchers, and patients or relatives of patients who had experienced TTTS were invited to participate. Consensus was defined a priori using the 15%/70% definition of the Core Outcome Measures in Effectiveness Trials (COMET) initiative. The modified nominal group technique was used to evaluate the consensus outcomes in a face-to-face consultation meeting and identify the final COS. RESULTS: One hundred and three participants, from 29 countries, participated in the three-round Delphi survey. Of those, 88 completed all three rounds. Twenty-two consensus outcomes were identified through the Delphi procedure and entered into the modified nominal group technique. The consensus meeting was attended by 11 healthcare professionals, two researchers and three patients; 12 core outcomes were prioritized for inclusion in the COS. Fetal core outcomes included live birth, pregnancy loss (including miscarriage, stillbirth, termination of pregnancy and neonatal mortality), subsequent death of a cotwin following single-twin demise at the time of treatment, recurrence of TTTS, twin anemia-polycythemia sequence and amniotic band syndrome. Neonatal core outcomes included gestational age at delivery, birth weight, brain injury syndromes and ischemic limb injury. Maternal core outcomes included maternal mortality and admission to Level-2 or -3 care setting. One aspirational outcome, neurodevelopment at 18-24 months of age, was also prioritized. CONCLUSIONS: Implementing the COS for TTTS within future research studies could make a substantial contribution to advancing the usefulness of research in TTTS. Standardized definitions and measurement instruments are now required for individual core outcomes. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

The development of Nursing Quality Care Process Metrics and Indicators for use in Older Persons Care Settings: A Delphi-Consensus Study.

AIM: To develop a suite of nursing quality care process metrics and indicators for older persons care settings in Ireland. BACKGROUND: Regulatory investigations of health system failures highlight non-adherence to clinical guidelines and standards resulting in deficiencies in nursing care delivery. Limited attention has been paid to measuring nursing care processes particularly in the care of older people. Quality care process metrics can facilitate measurement of nurse-sensitive measures of care. DESIGN: A scoping literature review and modified Delphi-Consensus Technique. METHODS: A scoping review of literature published between January 2007 - January 2017 was conducted to identify nursing process metrics and indicators. The Delphi Consensus phase incorporated a four-round electronic survey of 404 nurses and a consensus meeting with 13 stakeholders working in Older Persons Care Settings in Ireland. FINDINGS: From the review, 33 potential metrics were identified. After all Delphi survey rounds, 20 metrics and 90 associated indicators were selected by the nurses. Following the consensus meeting, 19 metrics and 80 indicators were included in the final suite of nursing quality care process metrics and indicators. CONCLUSION: Developing this suite of nursing quality care process metrics and indicators for use in older persons care settings provided consensus on what nursing processes should be measured to improve the quality and safety of care delivery. IMPACT: The nursing processes identified, provide a framework for future research and educational programmes in the care of older persons. Although conducted in the Irish healthcare system, there is potential for adoption or adaption in other healthcare settings.

Clinical indicators of wound infection and biofilm: reaching international consensus.

OBJECTIVE: To achieve international consensus relating to clinical indicators for a chronic wound, wound infection and biofilm presence to inform the development of international clinical guidance for assessing and managing wound infection. METHOD: An online Delphi consensus process of international key opinion leaders in infection was undertaken. A literature search underpinned the development of issue statements related to terminology, emerging topics and debate in the field of wound infection. Experts participated in three rounds of consensus voting, sharing their opinions and indicating their level of agreement with the issue statements. Votes were calculated using web-based software that implements a nominal group voting methodology previously published by Research and Development/University of California at Los Angeles. RESULTS: A total of 14 experts took part in the development process. Consensus was reached on clinical indicators of wound chronicity, wound infection and biofilm presence. Agreement was also reached that the term 'critical colonisation' should no longer be used to refer to a stage in the wound infection continuum. CONCLUSION: Outcomes from the consensus process were used to inform the development of international, evidence-informed guidance on the assessment and treatment of wound infection to promote improved outcomes for people with wounds.

The development of a template for psychological assessment of women considering risk-reducing or contralateral prophylactic mastectomy: A national Delphi consensus study.

OBJECTIVE: Risk-reducing mastectomies (RRM) and contralateral prophylactic mastectomies (CPM) are increasingly prevalent strategies to reduce breast cancer risk. Given the associated physical and emotional challenges, presurgical psychological assessment is frequently recommended for this population, yet limited research exists to guide this. This study aimed to reach a consensus on the most relevant content and format of a psychological consultation prior to RRM/CPM. METHODS: A modified two-round online Delphi study was conducted Australia-wide. Expert participants (n = 25), including psychologists, surgeons, nurses, oncologists, genetic specialists, and researchers completed a round-one survey, informed by a literature review, previous qualitative study and expert clinicians' input. This required participants to rate their agreement with 36 statements regarding potential content of a psychological consultation and provide feedback on format/structure. A round-two survey comprised items that had not reached consensus and six new items suggested by participants. Parameters for statement consensus were set a priori at >75% agreement. RESULTS: Expert participants indicated agreement with the majority of statements (39/42, 92.8%), endorsing that the assessment should include (1) patient understanding of the RRM/CPM procedure/cancer risk, (2) potential physical/emotional impact of surgery, (3) informed decision-making, and (4) past/current psychological issues (anxiety and body image). A provisional assessment template and user manual is provided. CONCLUSIONS: This research culminated in a consensus-based template to guide psychological assessment of women considering RRM/CPM. This enables health professionals to assess suitability for surgery and preempt challenges within a standardised framework. Future evaluation of the acceptability and effectiveness of the template in clinical settings is warranted.

Agreeing the content of a patient-reported outcome measure for primary care: a Delphi consensus study.

BACKGROUND: As the first contact for any health-related need, primary care clinicians often address multiple patient problems, with a range of possible outcomes. There is currently no patient-reported outcome measure (PROM) which covers this range of outcomes. Therefore, many research studies into primary care services use PROMs that do not capture the full impact of these services. OBJECTIVE: The study aim was to identify outcomes sought by primary care patients which clinicians can influence, thus providing the basis for a new primary care PROM. METHODS: We used a Delphi process starting with an outcomes list inductively derived in a prior qualitative study. Thirty-five experts were recruited into patient, clinician and academic panels. Participants rated each outcome on whether it was (i) relevant to health, (ii) influenced by primary care and (iii) detectable by patients. In each round, outcomes which passed/failed preset levels of agreement were accepted/rejected. Remaining outcomes continued to the next round. RESULTS: The process resulted in a set of outcomes occupying the domains of health status, health empowerment (internal and external), and health perceptions. Twenty-six of 36 outcomes were accepted for inclusion in a PROM. Primary care having insufficient influence was the main reason for exclusion. CONCLUSIONS: To our knowledge, this is the first time PROM outcomes have been agreed through criteria which explicitly exclude outcomes less relevant to health, uninfluenced by primary care or undetected by patients. The PROM in development covers a unique set of outcomes and offers an opportunity for enhanced research into primary care.

Developing a pressure ulcer risk factor minimum data set and risk assessment framework.

AIM: To agree a draft pressure ulcer risk factor Minimum Data Set to underpin the development of a new evidenced-based Risk Assessment Framework. BACKGROUND: A recent systematic review identified the need for a pressure ulcer risk factor Minimum Data Set and development and validation of an evidenced-based pressure ulcer Risk Assessment Framework. This was undertaken through the Pressure UlceR Programme Of reSEarch (RP-PG-0407-10056), funded by the National Institute for Health Research and incorporates five phases. This article reports phase two, a consensus study. DESIGN: Consensus study. METHOD: A modified nominal group technique based on the Research and Development/University of California at Los Angeles appropriateness method. This incorporated an expert group, review of the evidence and the views of a Patient and Public Involvement service user group. Data were collected December 2010-December 2011. FINDINGS: The risk factors and assessment items of the Minimum Data Set (including immobility, pressure ulcer and skin status, perfusion, diabetes, skin moisture, sensory perception and nutrition) were agreed. In addition, a draft Risk Assessment Framework incorporating all Minimum Data Set items was developed, comprising a two stage assessment process (screening and detailed full assessment) and decision pathways. CONCLUSION: The draft Risk Assessment Framework will undergo further design and pre-testing with clinical nurses to assess and improve its usability. It will then be evaluated in clinical practice to assess its validity and reliability. The Minimum Data Set could be used in future for large scale risk factor studies informing refinement of the Risk Assessment Framework.

Building Consensus on Domains of Wellness Using Finnish and International Expert Panels: A Delphi-Method Study.

PURPOSE: The paper investigates whether we can build consensus on wellness domains and create a more universal conceptual framework for wellness. DESIGN: A modified ranking type of Delphi method. PARTICIPANTS: Two separate panels consisting of 23 Finnish and 11 international experts. METHODS: Panels were asked to rate the importance of 61 systematic review-based wellness domains and to eventually form a wellness model in both panels. The similarities between the resulting models were investigated and a new conceptual framework for wellness was created. RESULTS: The Finnish model included 8 themes and 20 domains, and the international model 5 themes and eleven domains. Eight of the eleven domains were an exact match for the Finnish model (namely mental health, cognitive health, exercise, nutrition, community, life satisfaction, meaningfulness, work-life balance). There were also 2 similar domains that could be found in both models (namely self-care and lifestyle habits, social networks). A new conceptual framework for wellness was created based on these ten domains. CONCLUSION: The lack of consensus on the wellness construct has made it difficult to find comparable measures that could assess and improve the level of wellness of individuals, organizations, and society. This study offers a conceptual framework that can be further validated and turned into a more universal measurement instrument.

Medication Appropriateness for Older Nursing Home Patients With a Limited Life Expectancy: From STOPP/START Version 2 to the ReNeWAL Criteria.

OBJECTIVES: To adapt the 2015 Screening Tool of Older Persons' Prescriptions (STOPP)/Screening Tool to Alert to Right Treatment (START) criteria to older nursing home patients with a limited life expectancy of 1.5 to 2 years. DESIGN: A modified Delphi consensus study. SETTING AND PARTICIPANTS: The study was established in The Netherlands and conducted online. The international panel consisted of 23 experts with experience in medicine for older people. METHODS: The expert panel was presented with the 2015 STOPP/START criteria using an online survey program (Survey Monkey). The panelists were asked for their opinion on the appropriateness of the STOPP and START criteria, and adaptations to these criteria for older nursing home patients with a limited life expectancy on 4-point Likert scales. Consensus was defined as ≥70% of the panelists answering (very) inappropriate or (very) appropriate, and (completely) disagree or (completely) agree. RESULTS: Twenty-one panelists completed all 3 Delphi rounds. The final list of "Represcribing for Nursing home residents With A Limited life expectancy (ReNeWAL)" criteria comprises 132 criteria: 98 criteria to stop (70 original STOPP criteria and 28 adapted) and 34 criteria to start (16 original START criteria and 18 adapted) for older nursing home patients with a limited life expectancy. Considerations that panelists mentioned for adapting criteria were mainly prevention and treatment of discomfort. CONCLUSION AND IMPLICATIONS: It is clear that represcribing for older nursing home patients is highly complex and requires the consideration of various elements. The ReNeWAL criteria may be useful in enhancing represcribing for older nursing home patients with a limited life expectancy.

Protocol for developing a core outcome set for male infertility research: an international consensus development study.

STUDY QUESTION: We aim to develop, disseminate and implement a minimum data set, known as a core outcome set, for future male infertility research. WHAT IS KNOWN ALREADY: Research into male infertility can be challenging to design, conduct and report. Evidence from randomized trials can be difficult to interpret and of limited ability to inform clinical practice for numerous reasons. These may include complex issues, such as variation in outcome measures and outcome reporting bias, as well as failure to consider the perspectives of men and their partners with lived experience of fertility problems. Previously, the Core Outcome Measure for Infertility Trials (COMMIT) initiative, an international consortium of researchers, healthcare professionals and people with fertility problems, has developed a core outcome set for general infertility research. Now, a bespoke core outcome set for male infertility is required to address the unique challenges pertinent to male infertility research. STUDY DESIGN SIZE DURATION: Stakeholders, including healthcare professionals, allied healthcare professionals, scientists, researchers and people with fertility problems, will be invited to participate. Formal consensus science methods will be used, including the modified Delphi method, modified Nominal Group Technique and the National Institutes of Health's consensus development conference. PARTICIPANTS/MATERIALS SETTING METHODS: An international steering group, including the relevant stakeholders outlined above, has been established to guide the development of this core outcome set. Possible core outcomes will be identified by undertaking a systematic review of randomized controlled trials evaluating potential treatments for male factor infertility. These outcomes will be entered into a modified Delphi method. Repeated reflection and re-scoring should promote convergence towards consensus outcomes, which will be prioritized during a consensus development meeting to identify a final core outcome set. We will establish standardized definitions and recommend high-quality measurement instruments for individual core outcomes. STUDY FUNDING/COMPETING INTERESTS: This work has been supported by the Urology Foundation small project award, 2021. C.L.R.B. is the recipient of a BMGF grant and received consultancy fees from Exscentia and Exceed sperm testing, paid to the University of Dundee and speaking fees or honoraria paid personally by Ferring, Copper Surgical and RBMO. S.B. received royalties from Cambridge University Press, Speaker honoraria for Obstetrical and Gynaecological Society of Singapore, Merk SMART Masterclass and Merk FERRING Forum, paid to the University of Aberdeen. Payment for leadership roles within NHS Grampian, previously paid to self, now paid to University of Aberdeen. An Honorarium is received as Editor in Chief of Human Reproduction Open. M.L.E. is an advisor to the companies Hannah and Ro. B.W.M. received an investigator grant from the NHMRC, No: GNT1176437 is a paid consultant for ObsEva and has received research funding from Ferring and Merck. R.R.H. received royalties from Elsevier for a book, consultancy fees from Glyciome, and presentation fees from GryNumber Health and Aytu Bioscience. Aytu Bioscience also funded MiOXYS systems and sensors. Attendance at Fertility 2020 and Roadshow South Africa by Ralf Henkel was funded by LogixX Pharma Ltd. R.R.H. is also Editor in Chief of Andrologia and has been an employee of LogixX Pharma Ltd. since 2020. M.S.K. is an associate editor with Human Reproduction Open. K.Mc.E. received an honoraria for lectures from Bayer and Pharmasure in 2019 and payment for an ESHRE grant review in 2019. His attendance at ESHRE 2019 and AUA 2019 was sponsored by Pharmasure and Bayer, respectively. The remaining authors declare no competing interests. TRIAL REGISTRATION NUMBER: Core Outcome Measures in Effectiveness Trials (COMET) initiative registration No: 1586. Available at www.comet-initiative.org/Studies/Details/1586. TRIAL REGISTRATION DATE: N/A. DATE OF FIRST PATIENT'S ENROLMENT: N/A.

Strategies for implementing pet robots in care homes and nursing homes for residents with dementia: protocol for a modified Delphi study.

BACKGROUND: Pet robots are a type of technology-based innovation that have shown positive psychosocial benefits for people with dementia in residential facilities, such as improving mood and social interaction and reducing agitation. Nevertheless, little is known about how pet robots can be implemented in care homes and nursing homes for dementia care in real-world practice. The objectives of this study are to (1) identify contextualised implementation strategies for implementing pet robots into care homes and nursing homes for dementia care and (2) achieve consensus on the most relevant strategies. METHOD: This study is informed by a preceding scoping review and qualitative study, which used the Consolidated Framework of Implementation Research (CFIR) to identify multi-level determinants of implementation (i.e. barriers and facilitators). We will use the CFIR-ERIC matching tool to identify relevant implementation strategies from the Expert Recommendations for Implementing Change (ERIC) taxonomy to address these determinants. Data from the scoping review and qualitative study will be used to contextualise the generic ERIC strategies for our setting. After that, a group of key stakeholders will be consulted to further contextualise and refine these strategies. Next, a two-round modified Delphi process will be conducted. Fifty-four international expert participants including healthcare professionals and organisational leaders from care homes and nursing homes and academic researchers will be recruited through purposive sampling. During the first Delphi round, participants will be invited to rate the relevance of each implementation strategy on a 9-point Likert scale and provide comments or suggestions. Descriptive statistics will be used to identify whether consensus has been obtained. Inductive qualitative content analysis will be used to analyse and summarise textual responses for any new statements suggested by participants. Statements that do not reach consensus and new statements suggested in round 1 will be taken to the next round, which will follow the same rating process. DISCUSSION: This study will identify strategies for implementing pet robots in care homes and nursing homes for residents with dementia, which will have practical utility for clinicians, organisations and researchers. It will also demonstrate the practical application (and adaptation) of the CFIR-ERIC tool to identify and contextualise ERIC strategies.

[French clinical practice guidelines developed by a modified Delphi consensus process for oocyte vitrification in women with benign gynecologic disease]. / Indications de vitrification ovocytaire dans les pathologies gynécologiques bénignes : conseils de bonne pratique du CNGOF après étude de consensus par méthode Delphi.

OBJECTIVES: To provide clinical practice guidelines about fertility preservation (FP) for women with benign gynecologic disease (BGD) developed by a modified Delphi consensus process for oocyte vitrification in women with benign gynecologic disease. METHODS: A steering committee composed of 14 healthcare professionals and a patient representative with lived experience of endometriosis identified 42 potential practices related to FP for BGD. Then 114 key stakeholders including various healthcare professionals (n=108) and patient representatives (n=6) were asked to participate in a modified Delphi process via two online survey rounds from February to September 2020 and a final meeting. Due to the COVID-19 pandemic, this final meeting to reach consensus was held as a videoconference in November 2020. RESULTS: Survey response of stakeholders was 75 % (86/114) for round 1 and 87 % (75/86) for round 2. Consensus was reached for the recommendations for 28 items, that have been distributed into five general categories: (i) Information to provide to women of reproductive age with a BGD, (ii) Technical aspects of FP for BGD, (iii) Indications for FP in endometriosis, (iv) Indications for FP for non-endometriosis BGD, (v) Indications for FP after a fortuitous diagnosis of an idiopathic diminished ovarian reserve. CONCLUSION: These guidelines provide some practice advice to help health professionals better inform women about the possibilities of cryopreserving their oocytes prior to the management of a BGD that may affect their ovarian reserve and fertility. STUDY FUNDING/COMPETING INTEREST(S): The CNGOF (Collège National des Gynécologues Obstétriciens Français) funded the implementation of the Delphi process.

Allied health professions public health research priorities: A modified e-delphi study in the United Kingdom.

Objectives: This study identifies the United Kingdom (UK) Allied Health Professions (AHP) public health research priorities through a modified e-Delphi study conducted with an expert panel. Study design: A modified e-Delphi study was utilised in this study. Methods: This study used a modified e-Delphi approach to reach a consensus on research priorities. Expert panel members were invited to participate and complete three rounds of the e-Delphi. Ethical approval was obtained through the Public Health England Research and Evidence Governance Group. Results: A total of 38 participants completed three rounds of the e-Delphi study between September and November 2020. Consensus was reached on nine AHP public health research priorities. Conclusion: Several areas of AHP public health research were identified as priority, however, a number of priorities refer to the impact of AHP public health activities as opposed to empirical research. The identified priorities will be used to progress the AHP public health research agenda through a UK wide AHP public health strategy implementation group and through support and engagement from the AHP professional bodies and arm's length bodies.