A C TA Obstetricia et Gynecologica

AOGS EDIT ORS M ES SAGE

Pragmatism, dynamism and flexibility in research and clinical practice GANESH ACHARYA DOI: 10.1111/aogs.12615

Research findings need to be communicated and disseminated for them to be useful to society, and therefore scientists have an obligation to publish their results. Thousands of articles are published every day, and submissions to most mainstream journals are exponentially increasing. Despite a rigorous peer-review process, scientific publishing is not without flaws and it is associated with several biases. The ultimate aim of all biomedical/ health sciences research is to contribute to the improvement in understanding, diagnosis, management and prevention of diseases. However, only a small number of publications have a direct impact in achieving such goal. Therefore, pragmatism is desirable to avoid unnecessary use of resources and transparency is required to reduce research waste. Although it has become much easier to find information due to easy availability and access to online resources, researchers are continuously faced with the challenges of keeping up to date, not only with the advances in their chosen field of interest, but also with the ever growing requirements set by their institutions, funders, governments and international regulatory bodies and conventions. Although preparing a research protocol, obtaining funds, conducting research adhering to ethical principles and reporting findings in a transparent and honest manner still remain the main tasks, researchers today spend a substantial amount of their time filling forms and checklists. Some researchers see this as a hindrance to their work and productivity. Others may find it difficult to keep up with changing guidelines, rules and requirements. When a research report based on several years of hard work is rejected outright, for example, for the protocol not being registered in a clinical trials register, – it is easy to create unhappiness among the authors, occasionally even provoking some hostility towards the journal editors. However, journals have also an obligation to follow the rules and regulations. To improve the quality, clarity, completeness and transparency in health research reporting most prestigious medical journals today require authors to follow relevant guidelines. Fortunately, most of these guidelines are available at http:// www.equator-network.org, including an updated catalogue of reporting guidelines for health research in tabulated form. The guidelines on conducting and reporting biomedical research have been evolving with time. Perhaps the most significant event was the World Medical Association (WMA) Declaration of Helsinki outlining ethical principles for medical research involving human subjects in June 1964 (1). Minimizing risk, avoiding harm, taking care of confidentiality, obtaining ethics committee approval and informed consent from the participants have been the guiding principles from the very onset. The declaration has been amended several times (latest in 2013), and from

2008 onwards it requires that “every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.” The World Health Organization (WHO) and the International Committee of Medical Journal Editors (ICMJE) also support clinical trial registration requirement. Several registers exist today in six continents and some publically available are listed on the ICMJE website. Examples are: ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP), the ISRCTN Registry, EU Clinical Trials Register, Australian New Zealand Clinical Trials Registry (ANZCTR), Pan-African Clinical Trial Registry. Some countries such as Brazil, China, Cuba, India, Iran, Japan, Korea, Netherlands and South Africa have their own national registries. Recent efforts have been directed towards helping scientists to improve their research protocols and quality of reporting. Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) is an international initiative launched in 2013 (2) to improve the quality of clinical trial protocols by defining an evidence-based set of items. Better reporting of interventions: template for intervention description and replication (TIDieR) is a checklist and guide that was published in 2014 (3). The importance of registering a clinical trial in an appropriate register, publishing the protocol before starting to recruit participants, and reporting the interventions in sufficient detail to allow their replication by others, cannot be over-emphasized. The WMA Declaration of Helsinki also states “the welfare of animals used for research must be respected.” Use of animals in biomedical research must be ethically justified and approved by appropriate authorities. Prospective registration of preclinical studies is desirable, but whether this burden is justifiable given the short life cycle and duration (usually months rather than years) of preclinical trials remains debatable. The Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines were introduced in 2010 to help improve reporting standards (4). However, their implementation appears to have been slow. Gender bias in animal research created by preferred use of male animals is another issue that needs addressing in future. The Collaborative Approach to Meta-Analysis and Review of Animal Data from Experimental Studies (CAMARADES) initiative has been launched as an organization supporting researchers involved in meta-analyses of experimental animal studies. It is clear that the same standards which apply to clinical trials should also be applied to systematic reviews, including registration and publication of protocols. To minimize biased and/or incomplete reporting Quality of Reporting of Meta-analyses (QUOROM) guidelines were published in 1999, and were succeeded by Preferred Reporting Items for Systematic reviews and

ª 2015 Nordic Federation of Societies of Obstetrics and Gynecology, Acta Obstetricia et Gynecologica Scandinavica 94 (2015) 345–346

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Meta-analyses (PRISMA) guidelines in 2009 (5). In 2011, the first international prospective register of systematic reviews (PROSPERO) was launched by the Centre for Reviews and Dissemination, University of York, UK. AOGS encourages prospective registration of all planned systematic review protocols as it helps to promote transparency, safeguards against publication bias and duplication of reviews. Recently, PRISMA guidelines for protocols (PRISMA-P) have also been published (6). Some dynamism is required to keep up with the evolving changes in biomedical reporting and publishing guidelines. Enthusiasm, motivation, as well as flexibility, are needed to implement them successfully. It took several decades for the introduction, methods, results, and discussion (IMRAD) structure of scientific reporting to become firmly established and accepted in medical journals (7). A structured abstract is now the norm for reporting original research and systematic reviews in most medical journals. However, some flexibility is still required depending on the type of articles published. AOGS recommends non-structured abstracts for commentaries, narrative reviews and short research reports. In the past we have been less strict regarding registration of clinical trials as long as the study had appropriate ethical approval and was properly conducted. However, from now onwards this will be a requirement in line with other major journals. Some degree of flexibility may be required in some cases to allow retrospective registration that is available from the AllTrials campaign (www.alltrials.net). Registration is not required for purely observational (non-interventional) studies. As much as in research pragmatism is also required in clinical practice. Gathering best evidence and then applying it in patient management is important. A meta-analysis of randomized trials using individual patient-level data performed by Grabriele Saconne et al. published in this issue of AOGS (pages 352–358) is a good example of that. It shows that cerclage should not be recommended to prevent preterm birth in twin pregnancy with a short cervical length. A study by Diogo Ayres-De-Campos from Portugal (pages 391–398) shows that it is possible to reverse the increasing trend in cesarean section rates by providing proper information and training to healthcare professionals together with changes in hospital funding policy. Dynamism and flexibility are also equally important in clinical practice. As not everything we do in everyday practice is evidence-based, opinions and preferences regarding patient management vary among clinicians. A healthy discussion is the way forward in these situations, and it is highlighted by the commentary on forceps delivery by Prof. Hans Peter Dietz (pages 347–351).

Obstetrics and Gynecology is a very old specialty in medicine, but it has seen tremendous development in recent years due to scientific and technological advances. Continuing medical education to maintain, consolidate and improve knowledge and skills by the specialists and appropriate effective training of the residents and fellows is therefore important as ever. The NFOG Educational Committee is arranging a 2-day course “Nordic OBGYN training – are we good enough?” on 7–8 May 2015 with a focus on training needs of the trainers, and issues around assessment and feedback. Another important event before the start of summer holidays will be the First Nordic Congress on Gynecological Endoscopy on 3–5 June 2015 in Middelfart, Denmark. I hope that many colleagues from Nordic countries and beyond will attend these events.

References 1. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. Available online at: http://www.wma.net/en/30publications/10policies/b3/ 2. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7. 3. Hoffmann T, Glasziou P, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. 4. Kilkenny C, Browne WJ, Cuthill IC, Emerson M, Altman DG. Improving bioscience research reporting: the ARRIVE guidelines for reporting animal research. PLoS Biol. 2010;8: e1000412. 5. Moher D, Liberati A, Tetzlaff J, Altman DG; The PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6: e1000097. 6. Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015;4:1. 7. Sollaci LB, Pereira MG. The introduction, methods, results, and discussion (IMRAD) structure: a fifty-year survey. J Med Libr Assoc. 2004;92:364–7.

Upcoming meetings: Nordic OBGYN training – are we good enough? May 7-8 2015. Copenhagen, Denmark. www.nfog.org/ First Nordic Congress on Gynaecological Endoscopy. Minimal Invasive Gynaecological Surgery. June 3-5 2015. Hindsgavl, Denmark. www.NCGE2015.dk NOCOGO, Nordic Congress on Obesity in Gynaecology and Obstetrics. August 27-29 2015. Billund, Denmark. www.nocogo.dk/

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ª 2015 Nordic Federation of Societies of Obstetrics and Gynecology, Acta Obstetricia et Gynecologica Scandinavica 94 (2015) 345–346

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Pragmatism, dynamism and flexibility in research and clinical practice.

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