Research support essentials: Journals & articles

Abstract
Introduction: Regional anaesthesia provides important clinical benefits to patients but is underutilised. A barrier to widespread adoption may be the focus of regional anaesthesia research on novel techniques rather than evaluating and optimising existing approaches. Research priorities in regional anaesthesia identified by anaesthetists have been published, but the views of patients, carers and other healthcare professionals have not been considered previously. Therefore, we launched a multidisciplinary research priority setting partnership that aimed to establish key regional anaesthesia research priorities for the UK.

Methods: Research suggestions from key stakeholders (defined by their interaction with regional anaesthesia) were gathered using an online survey. These suggestions were analysed to identify common themes and then combined to formulate indicative research questions. After an extensive literature review, unanswered and partially answered questions were prioritised via an interim online survey and then ranked as a top 10 list during a final live virtual multidisciplinary prioritisation workshop.

Results: In total, 210 individuals completed the initial survey and suggested 518 research questions. Fifty-seven indicative questions were formed, of which three were considered fully answered after literature review and one not feasible. The interim online survey received 335 responses, which identified the 24 highest priority questions from the 53 presented. At the final live prioritisation workshop, through a nominal group process, we identified the top 10 regional anaesthesia research priorities. These aligned with three broad thematic areas: pain management (two questions); patient safety (six questions); and recovery from surgery (two questions).

Discussion: This initiative has resulted in a list of research questions prioritised by patients, carers and a multidisciplinary group of healthcare professionals that should be used to inform and support future regional anaesthesia research in the UK.

Abstract
Background: Health and medical research leads to improvements in healthcare globally. Identifying research priorities is important to researchers, funders, our patients, and other end users. This can ensure that the research is more broadly accepted and has greater impact.

Methods: An adapted version of the James Lind Alliance method was used to identify research priorities. An initial survey was promoted via social media, print media, clinic visits, and an emailed invitation to active researchers. Individuals were asked to list three questions or priorities for research in perioperative medicine. These responses were then collated into themes to match recommended standardised trial endpoints, followed by informal systematic reviews to identify the unanswered questions (priorities). These were then added to a 1000minds priority survey, and a working group then met to discuss and agree on the top 10 priorities.

Results: The first surveys resulted in 200 individual responses and 544 lines of text for analysis, with 60% of respondents being consumers (patients, carers, or knew someone who underwent surgery). The second survey consisted of 100 respondents, with 45% as patients/consumers. The top 10 research priorities covered equitable access to information and quality of care for culturally and linguistically diverse populations, preoperative decision-making, partnering in care, reducing infections after surgery, preanaesthetic health questionnaires, patient-centred care, preoperative fasting, prehabilitation, postoperative analgesic effectiveness, and risk prediction.

Conclusions: Research priorities are best determined in partnership between researchers, patients, clinicians, and other stakeholders. Our findings provide guidance for perioperative researchers in Australia, and elsewhere, when planning further research.

Abstract
Objective: To determine how many specialist trainees are required to conduct research projects, how they conduct these studies, and their views on the value of these activities; to assess the design and reporting quality of their research reports.

Study design: Online, anonymous survey.

Setting, participants: Current and recent trainees (past five years) at Australian and New Zealand specialist colleges, recruited through eleven colleges and snowballing; survey was available 31 March - 31 December 2021.

Main outcome measures: Whether trainees were required to conduct research as part of specialty training; how they conducted their projects; the skills mix of the project team and access to relevant expertise and supervision; trainee views on mandatory research during specialty training; research engagement after training. Respondents were invited to submit project reports for reporting and methodological quality evaluation.

Results: A total of 371 people commenced the survey; 361 respondents provided answers about mandatory research projects during specialist training, including 311 (86%) who had been required to complete projects. Seventy-six of 177 people who had completed projects (43%) provided information about 92 projects and submitted 34 project reports for evaluation. Thirty-eight projects (41%) investigated questions developed by the trainees alone; in 48 cases (52%) trainees had planned their projects with little outside input; of the 69 study protocols developed (75% of projects), 60 were developed by the trainees. The median proportion of time devoted to the research project exceeded 50% for trainees in ten of twelve colleges. Respondents typically worked in non-collaborative teams, restricted to members of their own specialty, and additional expertise was limited to statisticians, allied health professionals, and nurses. Eighty-seven of 174 participants who had completed projects (50%) felt that doing so was very or moderately important for their clinical careers; 36 of 67 respondents (54%) supported the requirement for scholarly projects during specialty training; 33 of 61 respondents (54%) had participated in research after completing training, and 44 (72%) had considered doing so. Twenty-five of 34 available reports had been published; in 27 assessable reports, methods and results reporting was generally poor, and the risk of bias moderate to high in all but three. Participants criticised using their own time for projects and their potentially low quality results.

Conclusion: For trainees who undertake specialty training, the time commitment and poor quality research associated with mandatory research projects were frequently concerns. Medical colleges should focus on research training tailored to individual career aspirations and training needs.

Keywords: Medical colleges.

Abstract
Large, randomised trials are the bedrock of evidence-based medicine, but the resources required to complete such trials greatly limit the number of important clinical questions that can be addressed within a reasonable period of time. Adaptive platform trials can identify effective, ineffective, or harmful treatments faster. These trials have been shown to deliver rapid evidence through the COVID-19 pandemic and are now being adopted across surgery and anaesthesia, with many opportunities for surgeons, anaesthetists, and other perioperative physicians to conduct and collaborate in platform trials.

Abstract
Objectives: Metrics and instruments can provide guidance for clinical researchers to assess their potential research projects at an early stage before significant investment. Furthermore, metrics can also provide structured criteria for peer reviewers to assess others' clinical research manuscripts or grant proposals. This study aimed to develop, test, validate, and use evaluation metrics and instruments to accurately, consistently, systematically, and conveniently assess the quality of scientific hypotheses for clinical research projects.

Materials and methods: Metrics development went through iterative stages, including literature review, metrics and instrument development, internal and external testing and validation, and continuous revisions in each stage based on feedback. Furthermore, two experiments were conducted to determine brief and comprehensive versions of the instrument.

Results: The brief version of the instrument contained three dimensions: validity, significance, and feasibility. The comprehensive version of metrics included novelty, clinical relevance, potential benefits and risks, ethicality, testability, clarity, interestingness, and the three dimensions of the brief version. Each evaluation dimension included 2 to 5 subitems to evaluate the specific aspects of each dimension. For example, validity included clinical validity and scientific validity. The brief and comprehensive versions of the instruments included 12 and 39 subitems, respectively. Each subitem used a 5-point Likert scale.

Conclusion: The validated brief and comprehensive versions of metrics can provide standardized, consistent, systematic, and generic measurements for clinical research hypotheses, allow clinical researchers to prioritize their research ideas systematically, objectively, and consistently, and can be used as a tool for quality assessment during the peer review process.

Abstract
With breakthroughs in Natural Language Processing and Artificial Intelligence (AI), the usage of Large Language Models (LLMs) in academic research has increased tremendously. Models such as Generative Pre-trained Transformer (GPT) are used by researchers in literature review, abstract screening, and manuscript drafting. However, these models also present the attendant challenge of providing ethically questionable scientific information. Our study provides a snapshot of global researchers' perception of current trends and future impacts of LLMs in research. Using a cross-sectional design, we surveyed 226 medical and paramedical researchers from 59 countries across 65 specialties, trained in the Global Clinical Scholars' Research Training certificate program of Harvard Medical School between 2020 and 2024. Majority (57.5%) of these participants practiced in an academic setting with a median of 7 (2,18) PubMed Indexed published articles. 198 respondents (87.6%) were aware of LLMs and those who were aware had higher number of publications (p < 0.001). 18.7% of the respondents who were aware (n = 37) had previously used LLMs in publications especially for grammatical errors and formatting (64.9%); however, most (40.5%) did not acknowledge its use in their papers. 50.8% of aware respondents (n = 95) predicted an overall positive future impact of LLMs while 32.6% were unsure of its scope. 52% of aware respondents (n = 102) believed that LLMs would have a major impact in areas such as grammatical errors and formatting (66.3%), revision and editing (57.2%), writing (57.2%) and literature review (54.2%). 58.1% of aware respondents were opined that journals should allow for use of AI in research and 78.3% believed that regulations should be put in place to avoid its abuse. Seeing the perception of researchers towards LLMs and the significant association between awareness of LLMs and number of published works, we emphasize the importance of developing comprehensive guidelines and ethical framework to govern the use of AI in academic research and address the current challenges.

Abstract in English, Spanish
Background: The connection between participants and their research team can affect how safe, informed, and respected a participant feels, and their willingness to complete a research project. Communication between researchers and participants is key to developing this connection, but there is little published work evaluating how communication during clinical research is conducted.

Purpose: This paper explores what communications happen (and how) with research participants in Australia post consenting to participate in clinical research. It provides reflections from Australians working in clinical research about their current strategies, or those they would like to use, to communicate with research participants.

Methods: This exploratory, qualitative descriptive study reports findings associated with twenty semi-structured interviews that were undertaken with people who work in clinical research in Australia (such as staff in participant facing, site management, or sponsor representative roles). These interviews were conducted and analysed inductively using thematic analysis.

Findings: Research staff reported using a range of communication strategies which varied in implementation, uptake, and suitability between clinical research studies and sites. Four major themes were identified in the interviews: [1] staff use innovative pragmatism to communicate; [2] staff tailor the communication strategies to fit the participants' context; [3] the site, its systems, and staff training all impact communication; [4] successful communication requires collaboration between stakeholders.

Conclusion: There are a variety of communication strategies, methods and activities research staff currently employ with trial participants, which vary in purpose, method, resources required, and suitability between studies and sites. Thorough consideration of the participants' contexts and the capacity of research sites is crucial for the design of studies which allow for effective communication between the research team and participants. The authors encourage those developing clinical research projects to involve site staff and consumer representatives early in planning for communication with participants.

Abstract
Objectives: This systematic review compares the long-term efficacy of cylindrical-lead spinal cord stimulation (CL-SCS) vs paddle-lead spinal cord stimulation (Paddle-SCS) for chronic pain management.

Materials and methods: We included prospective and retrospective studies with at least ten patients reporting on the efficacy of either lead type. Primary outcomes were pain score reduction (measured by the visual analog scale [VAS] and numeric rating scale [NRS]) and 50% pain relief after at least 12 months. Secondary outcomes included functional disability and complications, such as lead migration and infection rates. Meta-analyses compared effect sizes, while meta-regression and subgroup analyses addressed heterogeneity.

Results: A total of 96 studies, comprising 7726 patients, met the inclusion criteria. Paddle-SCS demonstrated superior pain reduction, with a standardized mean difference (SMD) of 5.37 (95% CI [5.35, 5.38]) compared with CL-SCS, which had an SMD of 4.09 (95% CI [4.08, 4.10]) on the VAS. However, CL-SCS outperformed Paddle-SCS on the NRS, with SMDs of 4.39 vs 2.35, respectively. For 50% pain relief, Paddle-SCS had a success rate of 41.4%, as opposed to 35.4% for CL-SCS. Paddle-SCS showed a lower migration rate (4.3% vs 7.2% for CL-SCS) but higher infection rates (5.0% vs 3.3%).

Conclusions: Paddle-SCS offers superior pain reduction (as measured by the VAS) and a lower migration rate, but a higher infection risk compared with CL-SCS. CL-SCS showed better outcomes as measured by the NRS. The choice between Paddle-SCS and CL-SCS should be individualized according to patient-specific factors and treatment goals. Further research with rigorous study designs is needed to provide clearer comparisons between these interventions.

Abstract
The personal, social and economic burden of chronic pain is enormous. Tremendous research efforts are being directed toward understanding, preventing, and managing chronic pain. Yet patients with chronic pain, clinicians and the public are sometimes poorly served by an evidence architecture that contains multiple structural weaknesses. These include incomplete research governance, a lack of diversity and inclusivity, inadequate stakeholder engagement, poor methodological rigour and incomplete reporting, a lack of data accessibility and transparency, and a failure to communicate findings with appropriate balance. These issues span pre-clinical research, clinical trials and systematic reviews and impact the development of clinical guidance and practice. Research misconduct and inauthentic data present a further critical risk. Combined, they increase uncertainty in this highly challenging area of study and practice, drive the provision of low value care, increase costs and impede the discovery of more effective solutions. In this focus article, we explore how we can increase trust in pain science, by examining critical challenges using contemporary examples, and describe a novel integrated conceptual framework for enhancing the trustworthiness of pain science. We end with a call for collective action to address this critical issue. PERSPECTIVE: Multiple challenges can adversely impact the trustworthiness of pain research and health research more broadly. We present ENTRUST-PE, a novel, integrated framework for more trustworthy pain research with recommendations for all stakeholders in the research ecosystem, and make a call to action to the pain research community.

Abstract
Aims: New randomized clinical trials (RCTs) should be initiated if previous systematic reviews (SRs) indicate that new trials are needed. We analysed whether RCTs published in anaesthesiology journals mentioned previous SRs as a rationale for conducting trial and for discussing results.

Methods: This was a meta-epidemiological, descriptive cross-sectional study. We analysed RCTs published in the seven first-quartile anaesthesiology journals between 2014 and 2016. We studied text and bibliography of the RCTs to assess whether the authors made a reference to previous SRs when justifying the need for their own clinical trial and discussing the results.

Results: In the 622 studied RCTs 126 (20%) mentioned verbatim or cited one or more SRs as justification for conducting a trial, most commonly in introduction of a manuscript. Almost half of the included RCTs (44%) did not cite a single systematic review. There was no significant difference between the years in the number of explicitly mentioned SRs as justification for conducting a trial (F = 0.540, p = 0.583). Trials citing, mentioning or explicitly using SRs as a justification were published in journals with significantly higher impact factor and included significantly higher number of participants, while there was no difference in using SRs in trials in terms of funding type, type of intervention or positive versus negative results.

Conclusions: Trialists should use evidence from existing SRs for planning a trial, while ethics committees, peer-reviewers and editors should require authors to provide evidence that a new trial is indeed necessary.

Significance: Since less than a fifth of trials published in high-impact journals in the field of anaesthesiology explicitly mention previous systematic review as a justification for conducting the trial, authors, ethics committees, editors and peer-reviewers need to increase their awareness of the need for proper justification regarding the necessity for a new trial.

Abstract
As anaesthesiologists face increasing clinical demands and a limited and competitive funding environment for academic work, the sustainability of academic anaesthesiologists has never been more tenuous. Yet, the speciality needs academic anaesthesiologists in many roles, extending beyond routine clinical duties. Anaesthesiologist educators, researchers, and administrators are required not only to train future generations but also to lead innovation and expansion of anaesthesiology and related specialities, all to improve patient care. This group of early career researchers with geographically distinct training and practice backgrounds aim to highlight the diversity in clinical and academic training and career development pathways for anaesthesiologists globally. Although multiple routes to success exist, one common thread is the need for consistent support of strong mentors and sponsors. Moreover, to address inequitable opportunities, we emphasise the need for diversity and inclusivity through global collaboration and exchange that aims to improve access to research training and participation. We are optimistic that by focusing on these fundamental principles, we can help build a more resilient and sustainable future for academic anaesthesiologists around the world.

Full citation:
Shorten G, Bahrey L, Bardia A, et al. A consensus statement on the meaning, value and utility of training programme outcomes, with specific reference to anaesthesiology: A consensus statement on training programme outcomes [published online ahead of print, 2023 Jun 21]. Eur J Anaesthesiol. 2023;10.1097/EJA.0000000000001868.

Keywords: Biostatistics; Clinical trials as topic.

Keywords: dissemination; publication; social media.

Objectives: To investigate the frequency and legitimacy of substantive changes to the research plans of published randomised controlled trials (RCTs) undertaken in Australia.

Design: Comparison of methodology and analysis plans for RCTs specified in protocol documents (full protocols, published protocol articles, statistical analysis plans, Australian New Zealand Clinical Trials Registry [ANZCTR] registration entries) and described in publications of primary results.

Setting, participants: 181 RCTs registered with the ANZCTR, 1 September 2007 - 31 December 2013, for which primary results had been published.

Main outcome measure: Changes made to research plan, both overall and by specific item (primary outcome, analysis set, eligibility criteria, sample size, primary analysis method, and treatment arms included in the primary comparison in multi-arm trials); trial characteristics associated with changes.

Results: Protocol documents were available for 124 of 181 eligible RCTs (69%; 46 publicly available, 78 provided by trial groups on request). Full audit of RCTs with protocols found clear or probable changes in 111 trials (90%), for 101 of which (91%) it was unclear whether changes had been made blinded to treatment outcomes. After seeking clarification from investigators, changes to 78 trials were confirmed (63%), for 61 of which (78%) changes were made blinded to treatment outcomes. Any change was less likely for trials with publicly available protocols than for trials for which we needed to request protocols (odds ratio, 0.22; 95% CI, 0.06-0.77). Limited reviews of trials without protocols identified that changes had been made to 42 of 57 trials (74%).

Conclusion: Changes to RCT study plans in Australia are both frequent and usually made appropriately blinded to treatment outcomes. However, the documentation of changes made to RCT protocols should be formalised to improve transparency.

Letter to the Editor.

Abstract
The Australian and New Zealand College of Anaesthetists (ANZCA) recently reviewed and updated the guideline on equipment to manage a difficult airway. An ANZCA-established document development group, which included representatives from the Australasian College for Emergency Medicine and the College of Intensive Care Medicine of Australia and New Zealand, performed the review, which is based on expert consensus, an extensive literature review, and bi-nationwide consultation. The guideline (PG56(A) 2021, https://www.anzca.edu.au/getattachment/02fe1a4c-14f0-4ad1-8337-c281d26bfa17/PS56-Guideline-on-equipment-to-manage-difficult-airways) is accompanied by a detailed background paper (PG56(A)BP 2021, https://www.anzca.edu.au/getattachment/9ef4cd97-2f02-47fe-a63a-9f74fa7c68ac/PG56(A)BP-Guideline-on-equipment-to-manage-difficult-airways-Background-Paper), from which the current recommendations are reproduced on behalf of, and with the permission of, ANZCA. The updated 2021 guideline replaces the 2012 version and aims to provide an updated, objective, informed, transparent, and evidence-based review of equipment to manage difficult airways.

Traditionally, dissemination of scientific research ends at the point where a paper is published in a peer-reviewed journal. However, most clinicians and patients to whom the work is relevant will never read it. Given the enormous resources invested, this limited reach can be disappointing to authors, patients, funders, sponsors and participants. Yet there are ways to enhance reach, which begins by first recognising that the scientific process does not finish with publication.

Abstract
In the last decade Open Science principles have been successfully advocated for and are being slowly adopted in different research communities. In response to the COVID-19 pandemic many publishers and researchers have sped up their adoption of Open Science practices, sometimes embracing them fully and sometimes partially or in a sub-optimal manner. In this article, we express concerns about the violation of some of the Open Science principles and its potential impact on the quality of research output. We provide evidence of the misuses of these principles at different stages of the scientific process. We call for a wider adoption of Open Science practices in the hope that this work will encourage a broader endorsement of Open Science principles and serve as a reminder that science should always be a rigorous process, reliable and transparent, especially in the context of a pandemic where research findings are being translated into practice even more rapidly. We provide all data and scripts at https://osf.io/renxy/ .

Description
Predatory journals, publishers and conferences are on the rise and becoming increasingly sophisticated. These practices prey on the pressure researchers feel to publish and present their work, and include pay-to-publish/present models without peer review, fake editorial boards listing respected scientists, fraudulent impact factors, journal and conference names deceptively similar to those of legitimate ones, and spam invitations to sham conferences with high registration fees.

Led by an independent working group of international experts nominated by academies around the world, this IAP study set out to improve the understanding of what constitutes predatory practices, gauge their prevalence and impact, identify their root causes and review efforts to address them. A key part of the study has been a voluntary survey of the global research community to gauge the awareness, extent and impact of predatory journals and conferences across different geographies, disciplines and career stages.

Data are increasingly used to govern science. Research evaluations that were once bespoke and performed by peers are now routine and reliant on metrics. The problem is that evaluation is now led by the data rather than by judgement. Metrics have proliferated: usually well intentioned, not always well informed, often ill applied. We risk damaging the system with the very tools designed to improve it, as evaluation is increasingly implemented by organizations without knowledge of, or advice on, good practice and interpretation.

Abstract
Objective: To identify research priorities for Anaesthesia and Perioperative Medicine.

Design: Prospective surveys and consensus meetings guided by an independent adviser.

Setting: UK.

Participants: 45 stakeholder organisations (25 professional, 20 patient/carer) affiliated as James Lind Alliance partners.

Outcomes: First 'ideas-gathering' survey: Free text research ideas and suggestions. Second 'prioritisation' survey: Shortlist of 'summary' research questions (derived from the first survey) ranked by respondents in order of priority. Final 'top ten': Agreed by consensus at a final prioritisation workshop.

Results: First survey: 1420 suggestions received from 623 respondents (49% patients/public) were refined into a shortlist of 92 'summary' questions. Second survey: 1718 respondents each nominated up to 10 questions as research priorities. Top ten: The 25 highest-ranked questions advanced to the final workshop, where 23 stakeholders (13 professional, 10 patient/carer) agreed the 10 most important questions: ▸ What can we do to stop patients developing chronic pain after surgery? ▸ How can patient care around the time of emergency surgery be improved? ▸ What long-term harm may result from anaesthesia, particularly following repeated anaesthetics?▸ What outcomes should we use to measure the 'success' of anaesthesia and perioperative care? ▸ How can we improve recovery from surgery for elderly patients? ▸ For which patients does regional anaesthesia give better outcomes than general anaesthesia? ▸ What are the effects of anaesthesia on the developing brain? ▸ Do enhanced recovery programmes improve short and long-term outcomes? ▸ How can preoperative exercise or fitness training, including physiotherapy, improve outcomes after surgery? ▸ How can we improve communication between the teams looking after patients throughout their surgical journey?

Conclusions: Almost 2000 stakeholders contributed their views regarding anaesthetic and perioperative research priorities. This is the largest example of patient and public involvement in shaping anaesthetic and perioperative research to date.

Abstract
This is the second article in a new series from the Arizona State University College of Nursing and Health Innovation's Center for the Advancement of Evidence-Based Practice. Evidence-based practice (EBP) is a problem-solving approach to the delivery of health care that integrates the best evidence from studies and patient care data with clinician expertise and patient preferences and values. When delivered in a context of caring and in a supportive organizational culture, the highest quality of care and best patient outcomes can be achieved.The purpose of this series is to give nurses the knowledge and skills they need to implement EBP consistently, one step at a time. Articles will appear every two months to allow you time to incorporate information as you work toward implementing EBP at your institution.

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Anesthesiology Research and Practice provides a forum for health care professionals engaged in perioperative medicine, critical care, and pain management.

The journal publishes original research articles, review articles, and clinical studies related to anesthetics administration, preoperative and postoperative considerations, perioperative care, critical care, paediatric anesthesia, obstetric anesthesia, analgesia, clinical and experimental research, administration and efficacy, as well as technology and monitoring.

NEJM Evidence offers a behind-the-scenes view of clinical trials that enables readers to develop a deeper understanding of the statistical methods used in trials, to become more sophisticated evaluators of medical evidence, and to learn from trial participants whose stories can help shape and inform the future direction of clinical trial design.