Research support essentials: Journals & articles

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.