Methodological Expertise Research Articles

How should trial teams make decisions about the proportions and diversity of the ethnic groups in their trial?

BackgroundThe benefits of randomised trials are not shared equally, and people from ethnic minority groups are a key constituency under-served by clinical research and clinical care. The STRIDE project aimed to give trialists practical information about how to decide which ethnic groups should be in their trials, and at what proportion.MethodsWe considered trials in six clinical areas: cancer, cardiovascular, diabetes, maternal health, mental health, and smoking cessation. We created a summary for each, including participants–intervention–comparators–outcomes, and data on disease prevalence by ethnicity. These were discussed with panels with clinical expertise, trial and methodology expertise, lived experience, funding, and experience of working with and on behalf of ethnic communities. For each trial, we asked panel members to decide which ethnic groups should have been involved and at what proportion.ResultsWe discussed 23 trials with 40 individual panel members. Panels found our questions difficult to answer. The lack of publicly available data on prevalence by ethnicity was central to this. Where data were available, decision-making was easier but not simple.The discussions led to eight STRIDE recommendations. We recommend that discussions involve diverse teams and that discussions need time, with access to the best available data. In the absence of data or consensus, we recommend the adoption of ‘default’ minimum rates of inclusion, with oversampling considered. These discussions should inform site selection, and the practical challenges of recruitment and retention should not determine which groups are to be included.We also suggest five policy initiatives to support implementation of the recommendations. Broadly, these are (1) funders need to signal that ethnic diversity is expected, (2) trial teams need access to better data, (3) funders and others need to signal that ethnic diversity means better science, (4) more funding is needed for evaluation, and (5) Good Clinical Practice training should cover ethnic diversity.ConclusionsAgreeing targets for which ethnic groups to involve in a trial is essential but difficult. Our eight recommendations could help to make trials more ethnically diverse if followed, and we suggest five policy initiatives that would create a supportive environment for their implementation.

Adapting the Future VET Curriculum in Response to Emerging Challenges: A Model for Evaluating the Impact of AI Integration in VET for Armed Conflicts and Warfare

This article examines the profound implications and the transformative impact of artificial intelligence (AI) on vocational education and training (VET) within military contexts, underscoring the imperative for curriculum reform to address the evolving demands of contemporary warfare. As AI technologies progress, they present both significant opportunities and challenges, reshaping defense strategies and operational frameworks, fundamentally altering defense strategies and operational paradigms. The integration of AI into military applications necessitates a workforce proficient in specialized competencies, including technical expertise in AI ethics, system design, and human-centered methodologies. This paper delineates the essential competencies required for future VET professionals, emphasizing the necessity for ongoing upskilling and reskilling to effectively navigate the ethical and legal complexities associated with AI in military operations. By incorporating and embedding AI education into VET curricula, stakeholders can cultivate a new generation of defense professionals equipped to utilize AI technologies in a responsible and effective manner, ensuring adherence to and compliance with international humanitarian standards while enhancing operational efficacy. The findings highlight the critical role of VET in developing a skilled workforce prepared to confront the dynamic landscape of military technologies driven by AI.

How and why do community stakeholders participate in the national stroke audit in England? Findings from a mixed-method online survey

BackgroundNational audit programmes are a recognised means of assessing quality of healthcare by collecting and reporting data in relation to evidence-based standards. The Sentinel Stroke National Audit Programme is a prospective audit of processes and outcomes for all stroke patients in England, Wales and Northern Ireland which has historically focused on hospital-based care. Evidence suggests it has been successful in driving quality improvement. What has yet to be explored is the influence of such a national audit programme on community-based healthcare. The aims of this study were to understand how community stakeholders perceive and participate in the audit. MethodsThe study used a realist approach, being theory driven and informed by collaborators including stroke clinicians and experts in realist and audit methodology. Contextual determinants and mechanisms were identified from the literature as having the potential to influence quality improvement. These were operationalised into 18 survey items, using a combination of 5-point scales and yes / no responses. Free text options offered the opportunity to expand upon responses.The online survey was distributed using social media, clinical networks and professional bodies. Representation was sought from community stroke stakeholders across England and from roles throughout the audit process including administrative, clinical, management and commissioning. ResultsThe survey achieved a national sample from a broad range of stakeholders (n=206). Participants reported being engaged in the audit, committing significant resources to participation. National audit feedback was described as being used to support a range of improvement activities, including funding for additional staff and service reorganisation. A number of factors influenced the ability of teams to participate in audit and utilise feedback for quality improvement. These included the online platform, the accuracy of data submitted and leadership support.ConclusionsFindings highlight the work needed in terms of the data captured, organisational audit support and engagement with feedback if the potential of the audit as a tool for quality improvement in community rehabilitation (as highlighted in acute stroke care) is to be realised.

Core Concepts in Pharmacoepidemiology: Principled Use of Artificial Intelligence and Machine Learning in Pharmacoepidemiology and Healthcare Research.

Artificial intelligence (AI) and machine learning (ML) are important tools across many fields of health and medical research. Pharmacoepidemiologists can bring essential methodological rigor and study design expertise to the design and use of these technologies within healthcare settings. AI/ML-based tools also play a role in pharmacoepidemiology research, as we may apply them to answer our own research questions, take responsibility for evaluating medical devices with AI/ML components, or participate in interdisciplinary research to create new AI/ML algorithms. While epidemiologic expertise is essential to deploying AI/ML responsibly and ethically, the rapid advancement of these technologies in the past decade has resulted in a knowledge gap for many in the field. This article provides a brief overview of core AI/ML concepts, followed by a discussion of potential applications of AI/ML in pharmacoepidemiology research, and closes with a review of important concepts across application areas, including interpretability and fairness. This review is intended to provide an accessible, practical overview of AI/ML for pharmacoepidemiology research, with references to further, more detailed resources on fundamental topics.

The Italian guideline on diagnosis and treatment of dementia and mild cognitive impairment.

Approximately 2 million people in Italy are currently living with dementia or mild cognitive impairment (MCI), and 4 million are involved as family members or caregivers. Considering the significant impact of dementia, the Italian Ministry of Health entrusted the Italian National Institute of Health (Istituto Superiore di Sanità) with the development of a guideline within the Italian National Guideline System (Sistema Nazionale Linee Guida, SNLG) on the diagnosis and treatment of dementia and MCI. The main objective was to provide evidence-based recommendations aimed at reducing the variability and ensuring the appropriateness of clinical practices throughout the whole care process from identification and diagnosis to the end of life for people with dementia (PwD) or MCI and their families/caregivers. The GRADE-ADOLOPMENT approach was used to adopt, adapt and update the guideline developed by the National Institute for Health and Care Excellence in 2018 (NG97). The methodology was based on the Methodological Handbook produced by the SNLG. A multidisciplinary panel of 29 experts and four representatives of family members/caregivers discussed and approved 47 review questions. Of these, 34 questions were adopted from the NG97, and 13 were new questions, including 10 questions referring to MCI. Systematic literature reviews were performed for each question, and a team of methodological and clinical experts qualitatively assessed and summarised results from included studies based on the GRADE approach. To facilitate the implementation and dissemination of the contents of this guideline, a care pathway and a leaflet dedicated to PwD or MCI and their families/caregivers were also developed. The literature review for this guideline included studies published up to November 2023. More than 1000 peer-reviewed publications were included, covering the following areas: (i) identification, diagnosis and post-diagnostic support; (ii) care models and care coordination; (iii) pharmacological interventions for cognitive symptoms; (iv) non-pharmacological interventions for cognitive symptoms; (v) non-cognitive symptoms, intercurrent illnesses and palliative care. The multidisciplinary panel discussed and approved 167 clinical practice recommendations and 39 research recommendations. Italy's first National Guideline on dementia and MCI addresses diagnosis, treatment and care within the National Healthcare System. It includes recommendations on pharmacological and non-pharmacological approaches, and emphasises tailored interventions, comprehensive cognitive assessment, staff training and palliative care. The guideline also underlines the need to involve PwD in decision-making and supporting caregivers throughout the entire course of the disease. Structured strategies for the dissemination and implementation of the guideline will be defined within the Italian Fund for Alzheimer and other Dementias 2024-2026. An interactive care pathway and a leaflet dedicated to PwD and their carers are already available. The guideline will be updated starting January 2027, but early updates may be planned in case of breakthrough advancements.

Practice guideline of influenza vaccination and antiviral drugs use in children(2024 editon)

Influenza is the most common acute respiratory infectious diseases among children in China. The annual seasonal influenza outbreak has a significant impact on children's health, poses a significant disease and socioeconomic burden, and arouses a wide public concern. In recent years, a number of new influenza vaccines and influenza antivirals have been approved for use in children, expanding the choices for prevention and treatment of influenza. Pediatric Infection Group, Chinese Society of Infectious Diseases of Chinese Medical Association and Infection Group, Pediatric Expert Committee of National Health Commission Capacity Building and Continuing Education, and China Clinical Practice Guidelines Alliance Methodology Committee organized a multidisciplinary guideline development group (GDG) consisting of experts in pediatrics, infectious diseases,epidemiologists,health policy,and guideline methodology proposed eight key issues concerning influenza vaccination and antiviral use from a practice perspective. Through research question construction, evidence retrieval and synthesis, evidence appraisal and evidence-to-decision discussion, recommendations and implementation suggestions were formulated. This guideline is intended to provide guidance for pediatricians at different facility levels and healthcare providers engaged in vaccination services,and institutional professionals dealing with prevention and control of infectious diseases.

A pragmatic approach to selecting a grading system for clinical practice recommendations in palliative care.

The limited palliative care evidence base is poorly amenable to existing grading schemes utilized in guidelines. Many recommendations are based on expert consensus or clinical practice standards, which are often considered 'low-quality' evidence. Reinforcing provider hesitancy in translating recommendations to practice has implications for patient care. To rationalize the selection of an appropriate grading system for rating evidence to support recommendations made in palliative care clinical practice guidelines. Review of the methodology sections of international palliative care guidelines published in English identified five grading systems comparison: Grading of Recommendations, Assessment, Development and Evaluations (GRADE); the Scottish Intercollegiate Guidelines Network (SIGN); Infectious Diseases Society of America-European Society for Medical Oncology (IDSA-ESMO); Confidence in the Evidence from Reviews of Qualitative research (CERQual) and the National Service Framework for Long Term Conditions (NSF-LTC). There is heterogeneity among grading systems used in published palliative care or terminal symptom management guidelines. GRADE has been increasingly adopted for its methodological rigour and inter-guideline consistency with other medical associations. CERQual has the potential to support recommendations informed by qualitative evidence, but its role in clinical guidelines is less defined. The IDSA-ESMO system has an intuitive typology with the ability to categorize tiers of lower-quality evidence. It is challenging to apply commonly used grading systems to the palliative care evidence base, which often lacks robust randomized controlled trials (RCTs). Adoption of IDSA-ESMO offers a feasible and practical alternative for lower-resourced guideline developers and palliative clinicians without a prerequisite for methodological expertise.

Competencias investigativas en docentes de ciencias de la salud

Teaching is a task that usually requires scientific research because, from it, knowledge is strengthened not only in the area of teaching performance but also in the development of pedagogical strategies. Considering these ideas, this article has proposed as a general objective, to characterize the research competencies of Health Sciences teachers in universities in Ecuador. In its methodological orientation, it is descriptive research with a documentary design that uses known databases, including Dialnet, Google Academic, and Scielo. Thus, authors and research are selected concerning the dimensions of teaching research competencies, that is, research, publications, methodological expertise, and digital literacy. Subsequently, the results are presented in categorical tables or analytical matrices that contrast the theoretical elements with some realities of universities in the country, specifically in the health area. Among the study findings, the need to strengthen teachers' research skills is specified based on their scientific production, the number of publications, and their task in terms of forging the student profiles they are in charge of in the classroom. It concludes with the projection of the desired teaching profile, in terms of skills for research in the field of health, which is pertinent to promote in higher education centers in Ecuador.

Designing an integrated care pathway for spondyloarthritis: A Lean Thinking approach.

Integrated care pathways (ICPs) are crucial for delivering individualised care. However, the development of ICPs is challenging and must be well designed to provide the expected benefits. Regarding this, healthcare organisations are increasingly adopting management systems based on Lean Thinking to improve their organisational processes by eliminating non-value-added steps. This study elucidates the process and evaluates the impact of applying Lean Thinking to redesign an ICP for patients with spondyloarthritis, a chronic inflammatory disease affecting young adults. A multidisciplinary team was assembled and trained in Lean Thinking. Patient's perspective was gathered through a focus group. Guided by an expert methodologist, the team constructed a value stream map of the entire care pathway and analysed each step. Five work streams were defined to increase value at each step, leading to targeted process improvements. Key process and outcome metrics were collected and compared in 2-month baseline and post-implementation audits. A total of 118 patients were included in the baseline audit (September-October 2022), and 116 in the post-implementation audit (January-February 2023). Process redesign resulted in statistically significant improvements (p < 0.05), including a reduction in the mean number of hospital visits per patient over a 2-month period from 2.54 (SD = 0.93) to 1.84 (SD = 0.79), an increase in complementary exams scheduled on the same day (81.4% to 94.8%) and an increase in baseline disease and treatment education (from 22.2% to 84.2% and from 18.2% to 84.6%, respectively). Regarding standardisation of clinical practice, there were significant increases in collecting data for medical records on composite activity indices (76.3% to 95.7%), reporting of pharmacological treatment adherence (68.6% to 94%) and providing nonpharmacological recommendations (31.3% to 95.7%). The application of Lean Thinking to redesign the spondyloarthritis ICP led to significant improvements in outpatient appointment scheduling, reduced patient hospital visits, improved interdepartmental coordination and standardised clinical practice.

Recommendations to improve use and dissemination of patient versions of oncological clinical practice guidelines in Germany: results of a multi-stakeholder workshop

BackgroundOncological patients have high information needs that are often unmet. Patient versions of oncological clinical practice guidelines (PVG) translate clinical practice guidelines into laypersons’ language and might help to address patients’ information needs. Currently, 30 oncological PVG have been published in Germany and more are being developed. Following a large multi-phase project on oncological PVGs in Germany, recommendations to improve use and dissemination of PVG were adopted in a multi-stakeholder workshop.MethodsOrganisations representing users of PVGs (patients, medical personnel, and multipliers), creators, initiators/funding organisations of PVGs, and organisations with methodological expertise in the development of clinical practice guidelines or in patient health information were invited to participate. The workshop included a World Café for discussion of pre-selected recommendations and structured consensus procedure for of all recommendations. Recommendations with agreement of > 75% were approved, and in case of ≤ 75% agreement, recommendations were rejected.ResultsThe workshop took place on 24th April 2023 in Cologne, Germany. Overall, 23 people from 24 organisations participated in the discussion. Of 35 suggested recommendations 28 recommendations reached consensus and were approved. The recommendations referred to the topics dissemination (N = 13), design and format (N = 7), (digital) links (N = 5), digitalisation (N = 4), up-to-dateness (N = 3), and use of the PVG in collaboration between healthcare providers and patients (N = 3).ConclusionThe practical recommendations consider various perspectives and can help to improve use and dissemination of oncological PVG in Germany. The inclusion of different stakeholders could facilitate the transfer of the results into practice.

Mixed methods research teams: leveraging integrative teamwork for addressing complex problems

Mixed methods research teams have garnered increased attention for their leveraging of diverse disciplinary and methodological expertise in pursuit of complex problems. We advance our theoretical viewpoint of integrative mixed methods research teamwork as necessary with empirical evidence demonstrating the equipping mixed methods researchers to study complex problems involving interacting systems and lacking known solutions. Integrative mixed methods research teamwork is distinguishable by the purposeful integration of qualitative and quantitative perspectives to generate novel outcomes that are greater than the sum of individual members’ contributions. Among the key dilemmas faced by mixed methods researchers wanting to work integratively within a team is the lack of practical guidance for how to get started, how to recognize the emergence of synergistic outcomes, and how to sustain a team’s integrative work. To begin addressing this gap, we describe three practical insights gleaned from examining our team interactions and outcomes using a reflection-in-action process during a recent empirical mixed methods case study of literacy practices. In our examination, we test the practical usefulness of a theoretical framework for demystifying the development of a mixed methods research team’s integrative capacity. Our insights contribute to refining teamwork practices by identifying enablers of integrative capacity and proposing ways to overcome hindrances that have not been previously elucidated. We argue that the capacity for integrative teamwork is essential for researchers employing mixed methods, allowing them to leverage inherent synergies when addressing complex problems.

The need for state-of-the-art orthopedic surgical technology in low- to middle income countries : The case of distraction epiphyseolysis for limb lengthening in children with fibular hemimelia in Uzbekistan.

Amongst low- to middle income countries (LMIC), outdated and poorly documented orthopedic interventions may pose patients at risk for complications, serious adverse events (SAE) and unsatisfactory results, contradicting the World Health Organization's (WHO) Safe Surgery mandates. Use cases of conditions managed inadequately in LMIC environments are necessary to increase awareness of stakeholders and overcome deficiencies in collaboration with high-income countries (HIC). Methodological and clinical experts from the BG Kliniken and the Charité, Berlin, Germany, were invited to investigate established processes for musculoskeletal disorders and injuries in Tashkent, Uzbekistan. Congenital lower leg discrepancy due to fibular hemimelia was recognized as an illustrative example to prove the effectiveness of local treatment guidelines, still relying on distraction epiphyseolysis (chondrodiatasis) via an Ilizarov frame. Routine data from hospital records, images and outpatient follow-up examinations were compared to estimates from a review of studies of limb-lengthening by other techniques. Data from 16 of 49 immature patients (10 males, 6 females, mean age at surgery, 4.2 ± 2.3 years) undergoing chondrodiatasis between 2017 and 2021 showed a mean limb elongation of 2.4 (95% confidence interval [CI], 1.9 to 2.9) cm after a median follow-up of 29 (range, 24 to 36) months. While no complications or SAE were noted, findings are compatible with a risk of 21% under an upper 97.5% confidence limit for null events. No reproducible classification of hemimelia, surgical or general complications, assessment of functional outcomes or health-related quality of life were available. The pooled average length gain from 21 studies on different other interventions with osteotomy enrolling 458 limbs was 5.1 (95% CI, 5.0 to 5.3) cm. Limb lengthening for hereditary fibular hemimelia in Uzbekistan revealed rather obsolete surgical algorithms, inadequate documentation, and unreliable outcome assessment. Resource limitations notwithstanding, knowledge transfer, implementation of current procedures and hardware, and international collaboration is vital to improve quality of care in this scenario and for the benefit of LMIC in general.

Prevalence, patterns and predictors of paranormal beliefs in The Netherlands: a several-analysts approach

Paranormal beliefs encompass a wide variety of phenomena, including the existence of supernatural entities such as ghosts and witches, as well as extraordinary human abilities such as telepathy and clairvoyance. In the current study, we used a nationally representative sample ( N = 2534 ) to investigate the presence and correlates of paranormal beliefs among the secular Dutch population. The results indicated that most single paranormal phenomena (e.g. belief in clairvoyance) are endorsed by 10–20% of Dutch respondents; however, 55.6% of respondents qualify as paranormal believers based on the preregistered criterion that they believe in at least one phenomenon with considerable certainty. In addition, we invited four analysis teams with different methodological expertise to assess the structure of paranormal beliefs using traditional factor analysis, network analysis, Bayesian network analysis and latent class analysis (LCA). The teams’ analyses indicated adequate fit of a four-factor structure reported in a 1985 study, but also emphasized different conclusions across techniques; network analyses showed evidence against strong connectedness within most clusters, and suggested a five-cluster structure. The application of various analytic techniques painted a nuanced picture of paranormal beliefs and believers in The Netherlands and suggests that despite increased secularization, subgroups of the general population still believe in paranormal phenomena.

Principle versus practice: the Institutionalisation of ethics and research on the far right

ABSTRACT Institutional ethics review procedures aim - in principle - to minimise harm and evaluate risks, providing an important space to consider the safety of participants and researchers. However, literature has questioned the effectiveness of the process, particularly for reviewing ‘risky’ topics in a risk-averse environment. This article reports the findings of interviews with 21 researchers of the far right and manosphere to understand how early career researchers perceive and engage with the process as a component of risk management. It argues that scholars experience IRBs struggling to meet their normative goal of ‘no undue harm’ due to a focus on legality and liability whilst lacking topical and methodological expertise. The lack of expertise produced misperceptions of risk, establishing institutional ethics as an obstacle rather than evaluative aid, creating holes in the ‘safety net’ that institutional ethics can provide. These findings contribute to concerns raised about the effective management of risk by early career researchers and the ethical review of ‘sensitive’ topics.

Effective and inclusive mentorship in the field of epidemiology.

Quality mentoring improves outcomes across career stages, including a sense of belonging, persistence, and productivity. However, the status quo in mentorship culture-including in epidemiology-is an ad hoc approach. This pervasive culture adversely affects individual mentees and the entire scientific research enterprise. Public health disciplines such as epidemiology bear a distinct responsibility to foster an inclusive mentorship culture, ensuring the next generation is equipped not only with methodological expertise but also with a commitment to diversity, equity, inclusion, and the principles of public health. In this commentary, we outline the primary attributes of effective mentors, core competencies, and the evidence base underlying how mentors can improve their skills with comprehensive training. We call on mentors, as well as institutional leaders, to make personal and structural changes, such as requiring mentor training, implementing evidence-based tools (e.g., individual development plans), and regularly evaluating mentorship quality. Institutional leaders can remove barriers (e.g., costs to enroll in mentor training) and facilitate mentorship in non-monetary ways, for example, by making it a formal part of the promotion process. Mentors and leaders must champion these changes, fortifying not only individual career trajectories but also advancing scientific integrity, inclusivity, and justice within the epidemiologic community.

Guideline for the diagnosis and treatment of incomplete Kawasaki disease in children in China

BackgroundKawasaki disease (KD) is a pyretic ailment predominantly observed in children aged below 5 years. There is currently a dearth of precise markers for timely identification of incomplete Kawasaki disease (IKD). It is imperative to develop updated, comprehensive, and evidence-based guidelines to effectively direct clinical practice.MethodsThe guideline development group comprised individuals with diverse expertise in both content and methodology and carried out an extensive exploration of the following digital repositories: CNKI, VIP, Wanfang Data, UpToDate, BMJ, Clinical Evidence, National Guideline Clearinghouse, Joanna Briggs Institute Library, Cochrane Library, and PubMed. The entire period from the establishment of these databases until January 1, 2024 was covered. To evaluate IKD, systematic reviews and randomised controlled trials were assessed using the risk of prejudice instrument specified in the Cochrane Handbook, along with the evidence robustness framework established by the GRADE group. The recommendations were formulated based on the findings, considering the evidence strength. After several iterations of expert consensus, the relevant professional committees in China endorsed the ultimate guideline.ResultsThese guidelines address clinical questions regarding the classification and definition of KD, diagnosis of IKD, treatment during the acute phase of IKD, and follow-up of IKD.ConclusionsTo provide healthcare professionals with guidance and decision-making bases for the diagnosis and treatment of IKD in China, 13 recommendations were formulated based on expert consensus and evidence of best practices.

Systematic reviews of the literature: an introduction to current methods.

Systematic reviews are a type of evidence synthesis in which authors develop explicit eligibility criteria, collect all the available studies that meet these criteria, and summarize results using reproducible methods that minimize biases and errors. Systematic reviews serve different purposes and use a different methodology than other types of evidence synthesis that include narrative reviews, scoping reviews, and overviews of reviews. Systematic reviews can address questions regarding effects of interventions or exposures, diagnostic properties of tests, and prevalence or prognosis of diseases. All rigorous systematic reviews have common processes that include: 1) determining the question and eligibility criteria, including a priori specification of subgroup hypotheses 2) searching for evidence and selecting studies, 3) abstracting data and assessing risk of bias of the included studies, 4) summarizing the data for each outcome of interest, whenever possible using meta-analyses, and 5) assessing the certainty of the evidence and drawing conclusions. There are several tools that can guide and facilitate the systematic review process, but methodological and content expertise are always necessary.

Development of an intervention for patients following an anterior cruciate ligament rupture: an online nominal group technique consensus study

Objectives(1) To develop an intervention for to support patients diagnosed with an anterior cruciate ligament (ACL) rupture with decision-making regarding treatment. (2) To define evidence-based recommendations for the treatment of...

O-240 Embryo assessment: the Istanbul consensus revised

Abstract Study question What are the current recommended criteria for morphological assessment of oocytes, zygotes and embryos? Summary answer The present ESHRE/Alpha Scientists in Reproductive Medicine consensus document provides several novel recommendations to assess oocyte and embryo morphology and rank embryos for transfer. What is known already A previous Alpha Scientists in Reproductive Medicine / ESHRE consensus on oocyte and embryo morphological assessment was published in 2011. After more than a decade, a thorough review and update was needed. Study design, size, duration A working group consisting of Alpha Scientists in Reproductive Medicine executive board members and ESHRE Special interest group of Embryology members formulated recommendations on oocyte and embryo morphological assessment. Participants/materials, setting, methods The working group included 17 internationally recognized experts with extensive experience in clinical embryology. Seven members represented Alpha Scientists in Reproductive Medicine and 8 members represented ESHRE, in addition to two methodological experts from the ESHRE central office. Based on a systematic literature search and discussion of existing evidence, the recommendations of the Istanbul Consensus (2011) were reassessed and, where appropriate, updated based on consensus within the working group. After stakeholder review, the final version will be approved by the working group, the Alpha executive board and the ESHRE Executive Committee. Main results and the role of chance This updated consensus paper provides 20 recommendations focused on the timeline of preimplantation developmental events and morphological criteria for oocyte, zygote, and embryo assessment. Based on duration of embryo culture, recommendations are given on the frequency and timing of assessments to ensure safety and effectiveness. Limitations, reasons for caution Several criteria relevant to oocyte and embryo morphology have not been well studied, leading to either a recommendation against their use for grading or for use in ranking rather than grading. Future updates may require further revision of these recommendations. Wider implications of the findings This document provides embryologists with clear advice on best practices when assessing oocyte and embryo quality based on the most recent evidence.

Qualitative Research: An Interview with Margaret Roller

In this edition of “Interview the Expert,” we are joined by our Associate Editor Margaret Roller, a renowned expert in qualitative methodology and passionate supporter of mixed-methods research. Margaret is the lead author of the book she co-wrote with Paul Lavrakas “Applied Qualitative Research Design: A Total Quality Framework Approach,” which received the AAPOR Book Award in 2021. Margaret is a professional moderator and interviewer with a 40-plus-year career in qualitative research. She shares her expertise and knowledge on the many aspects of quality research design in her blog “Research Design Review” and delivers training in qualitative methods.