Towards evidence-based medicine in surgical practice: Best BETs

Towards evidence-based medicine in surgical practice: Best BETs

EDITORIAL International Journal of Surgery 9 (2011) 585–588 Contents lists available at ScienceDirect International Journal of Surgery journal homep...

141KB Sizes 1 Downloads 59 Views

EDITORIAL International Journal of Surgery 9 (2011) 585–588

Contents lists available at ScienceDirect

International Journal of Surgery journal homepage: www.theijs.com

Editorial

Towards evidence-based medicine in surgical practice: Best BETs a b s t r a c t Keywords: Evidence-based medicine Classification Surgery Levels of evidence

Surgeons are faced with the dilemma that many clinical questions in their daily practice to do not have universally agreed answers, but patients increasingly demand the ‘best practice’ from their doctors. In addition time pressures mean that clinicians are unable to keep up with the full spectrum of published research. We have adopted an approach first pioneered in emergency medicine, namely the Best Evidence Topic or Best BET. Clinicians select a clinical scenario from their daily practice that highlights an area of controversy. From this, a three-part question is generated and this is used to search Medline and other appropriate databases for relevant papers. Once the relevant papers are found, these papers are critically appraised, the relevant data to answer the question is extracted, tabulated and summarised. A clinical bottom line is reached after this process. The resulting BETs, written by practising surgeons can then provide robust evidence-based answers to important clinical questions asked during our daily practice. Ó 2011 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

1. Introduction

2.1. Describing a clinical scenario

In order to achieve the optimal care for patients undergoing surgical intervention it is essential that their management is based upon the best available evidence. While other hospital and community specialities benefit from many resources that collate and summarize the available evidence,1–3 these resources are notable for the relative paucity of data on surgical research. Part of the reason for this is the inherent “artistry” involved in even a simple surgical procedure which means that there is a huge variety in the approaches to intra- and peri-operative management. Although some important questions in surgery have been addressed through systematic reviews and meta-analysis of randomised controlled trials (RCTs), the particular problem facing many surgical specialities is that the majority of evidence that does exist is frequently not of the highest quality.4 Therefore rigid critical appraisal filters tend to discard the majority of these papers as methodologically flawed or poorly designed. In an attempt to deal with this issue, a group of European cardiothoracic surgeons adopted an approach first pioneered by the Emergency Department at the Manchester Royal Infirmary known as Best BETs.5 Best BETs have since been published regularly in peerreviewed journals (including the Emergency Medicine Journal,6 Archives of Disease in Childhood7 and the Interactive Journal of Thoracic and Cardiovascular Surgery8 and are also listed on a dedicated website (www.bestbets.org)).9 Such Best BETs tend to be highly cited which demonstrates their value to the scientific and surgical communities.

BETs are generated as a result of clinical questions that face surgeons in their daily practice. Thus as the first step, a clinical scenario is presented that clearly illustrates the topic and ensures that each topic is rooted in clinical practice and will be of immediate use to clinicians.

2. Generating a best BET This process of generating a Best Bet has been previously described8 is summarised in a Fig. 1. As shown the process involves the following steps:

2.2. Posing a three-part question In order to ensure that the question is well defined and answerable, the clinical scenario is then summarised as a three-part question namely: 1. (P) Patient characteristic or patient group 2. (I) Intervention(s) or defining question with or without a comparison group (C). 3. (O) Outcome(s) An example of a clinical scenario and three-part question is shown below: Clinical scenario You are at a multi-disciplinary team meeting discussing of a patient with a potentially resectable adenocarcinoma of the distal oesophagus. He has undergone neoadjuvant chemotherapy and is scheduled for an open two-stage Ivor Lewis oesophagectomy. One of the surgeons offers to perform this procedure by laparoscopic gastric mobilisation followed by open thoracotomy while another argues that this approach is unproven. You wonder who is right and resolve to check the literature to determine whether laparoscopically-assisted oesophagectomy (LAO) is associated with better outcomes as compared with open surgery. Three-part question In [patients who are undergoing trans-thoracic oesophagectomy for carcinoma of the distal oesophagus] Does [laparoscopic mobilisation of the stomach] as compared to [open mobilisation] Improve [clinical outcomes?]

1743-9191/$ – see front matter Ó 2011 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.ijsu.2011.08.001

EDITORIAL 586

Editorial / International Journal of Surgery 9 (2011) 585–588

2.3. Performing a literature search A key component of the Best Evidence Topic is that all the ‘best available’ evidence is reviewed, as only then can strong conclusions be drawn about the particular topic. A major strength of BETs is that they are not exhaustive systematic reviews and as and thus rather than taking months to perform, they take on average 5 h to complete.10 They may be referred to as ‘shortcut reviews’ for this reason, although they have a robust methodology. It must be realised that non-English language studies may be marginalised during this process and no attempts are made to search the grey literature, unpublished literature or to statistically aggregate the data. Thus what is offered by BETs are practical answers to clinical questions by clinicians, rather than long reviews and summaries of the full body of research on that topic. As such are particularly appropriate to answer small focussed questions in surgery that would not otherwise be answered by full exhaustive systematic reviews. The main tool used in the literature search is Medline - a database of over 20 million citations from the biomedical literature from 1966 onward, compiled by the National Library of Medicine in the USA. In order to achieve the aims of the BET- namely finding and summarising the best evidence, it is important that the search strategy has a high sensitivity (meaning that it has the highest likelihood of retrieving all relevant papers). In order to achieve this, the search is done in stages. Each section of the three-part question is taken individually, and as many terms as possible are combined using the Boolean operator ‘OR’ to find all abstracts that contain information on that area. This now creates a search for each section of the three-part question. These three sections are then combined

using the Boolean operator ‘AND’ to find papers that contain information on all three areas of your question. This is a well-recognized method for performing sensitive searches and has been described in detail by Greenhalgh.11 We aim to find around 50–200 abstracts that we can then handsearch for relevance. However, two problems commonly occur during searching: either too many abstracts are found or too few. If too few abstracts are found, the sensitivity of the search needs to be increased. This may be done by using more terms in the search including plural versions and alternative spellings and by using the ‘explode’ function for Medical Subject Headings (MeSH) to include families of terms that all fall under a single MeSH heading. If this fails to increase the number of available abstracts, an author may consider searching other resources with broader content coverage. These may include SCOPUS (45 million records), EMBASE (24 million records) and the Cochrane Database of systematic reviews.1 These additional resources are usually only necessary if no relevant papers have been found on Medline, as additional searches help to assure readers that there really were no papers that could answer the clinical question. If too many abstracts are found, the search is not specific enough. Care must be taken when increasing the specificity not to eliminate abstracts which would be potentially useful. While the search terms themselves can be changed it is often better to use other techniques such as the LIMIT command limiting, for example, the search to human studies, or to use a methodological filter to look only for RCTs to achieve the desired outcome.5 Often the search may need to be done a few times to discover the best yielding terms, and the three-part question may need to be changed pragmatically as often searching for ‘survival or outcome’ may result in a poor specificity,

Generating a clinical scenario 2.4. Identifying the relevant papers that best address the question posed

Posing a three-part question

Performing a literature search

Once a satisfactory number of abstracts have been found, the titles and abstracts now need to be further scanned, as the majority of abstracts will not be relevant to the clinical question. From a search that finds 50–200 abstracts it is usual to find only 5–10 papers that require critical appraisal from the full text article. This scanning process is quite quick and therefore we recommend that it is better to scan a larger number of abstracts rather than risk missing relevant papers by over refining the search. 2.5. Appraising the papers

Identifying the relevant papers

Appraising the relevant papers

Tabulating the key results

Discussion and clinical bottom line Fig. 1. Flowchart demonstrating how to write a Best BET article.

The papers found by the search strategy are now requested and appraised. The appraisal of each paper should be performed in a structured way. Although there are no proscriptive methods for performing this process, there are a number of useful critical appraisal checklists which may be useful in assessing papers for methodological and analytical soundness and help uncover any significant methodological flaws.12–14 We suggest that firstly the relevant papers be categorised in terms of the type of study and the level of evidence presented as classified by the latest Oxford Level of Evidence2: Level I: Systematic review of randomized trials or n-of-1 trials Level II: Randomized trial or observational study with dramatic effect Level III: Non-randomized controlled cohort/follow-up study Level IV: Case-series, case-control studies, or historically controlled studies Level V: Mechanism-based reasoning

EDITORIAL Editorial / International Journal of Surgery 9 (2011) 585–588

587

Table 1 Example of format of the Best BET table. Author, date and country

Patient group (OO ¼ open Study type oesophagectomy and level LAO ¼ laparoscopic of evidence assisted oesophagectomy)

Kitigawa et al., 36 patients with 2009 3, Japan oesophageal cancer OO n ¼ 20 LAO n ¼ 16

Outcomes

Level IV Survival Retrospective (OO vs. LAO) cohort study Other outcomes (OO vs. LAO)

Key results

Comments

Hospital mortality: 5% vs. 0% (not significant) Mean intraoperative blood loss: 1067 ml vs. 496 ml (p [ 0.001) Intubation Time: 3.3 days vs. 1.6 days (p [ 0.004) Intensive care stay: 4.1days vs. 1.8 days (p [ 0.001) Serious morbidity (including pneumonia, anastomotic leak and recurrent laryngeal nerve palsy): 60% vs. 37% (not significant)

This retrospective study showed a reduction in length of intensive care and total hospital stay, and a reduction in estimated blood loss associated with LAO. It is confounded by introduction of early post-operative nutrition part-way through the study period, which meant that the LAO group has a higher incidence of post-operative jejunal feeding.

Generally, in constructing the BET we are interested in the papers of the highest available level of evidence only. Thus if there are sufficient papers of level I evidence then there is no need to include papers of level II or III evidence in the final BET. In contrast, if there are several level III papers but no papers better than this, then these will all be considered. The next step would be to evaluate the detailed methodology of the papers to assess any confounding factors, potential bias and limitations of the study (e.g. limited follow-up, small cohort size etc). The final step would be to select the outcome measures you are interested in and then review each of the papers to see if this outcome is quoted and what the impact of the intervention has been on this measure. For example, in the case of the previous quoted question on laparoscopic mobilisation of the stomach during oesophagectomy, the selected outcome measures might be in-hospital mortality rate, post-operative morbidity, length of ICU stay, length of hospital stay and mean lymph node yield. Each paper would then be analysed to see what impact laparoscopic mobilisation had on each of these parameters. It should be noted that the outcomes measures should not be too rigid and it is often the case that the outcomes measures initially identified during the construction of the three-part question may be altered on reviewing the papers. For example, on reviewing the relevant papers addressing the question of laparoscopic mobilisation, most papers noted and reported a difference in operative time and this was therefore added as an outcome measure. 2.6. Tabulating the results The relevant papers are then summarized in a table using the standardised form- a truncated example of which is shown in Table 1. As show the Table has six column headings:

1) Author, date and country of research 2) Patient group 3) Study type and level of evidence 4) Outcomes 5) Key results 6) Comments on the findings, provisos and weaknesses of the study.

The aim of the table is to provide enough relevant data about each paper so that the reader should not need to refer back to the cited paper for additional information. In addition, an important feature of the Table is that where possible each paper is presented and summarised in the same way to allow easy comparison (i.e. where possible the same key outcomes should be listed for all of the papers). 2.7. Discussion and clinical bottom line A search has now been performed, relevant papers identified and appraised, and the results of the studies tabulated in a standardised format. The salient features of the papers are summarised and any issues arising from the critical appraisal of the papers discussed. This section can also be used to highlight the need for further research. At the end of the discussion section, a clinical bottom line should be derived which provides a definitive answer to the three-part question based on the reviewed literature. The total length of the article (excluding the Table and references) should not exceed 1500 words with a maximum of six authors. 2.8. Revisiting and updating the best bet Best Evidence topics are a review of the literature at a point in time. However, all BETs published in the IJS will be given a ‘shelflife’, after which the search strategy will be reviewed and re-run. Any additional papers that are relevant can then be reassessed and the BET updated. It is envisaged that this would occur approximately every 5 years for each BET. 3. Conclusions The purpose of Best BETS is to encourage the delivery of evidence-base practice in all aspects of surgery and to encourage all members of the surgical community to participate in this process. We stress that they are not designed to undermine the gold standard of well-conducted systematic reviews and metaanalyses. The IJS is keen to accept topics on all aspects of surgery including breast surgery, vascular and endovascular surgery, gastrointestinal, endocrine, transplant, emergency and trauma surgery. As such we would encourage our readers to devise questions relevant to their day-to-day practice. These topics can then be registered with the IJS and commissioned by the journal for publication subject to passing satisfactory peer-review. The International Journal of Surgery has sought to raise standards within the field of surgical publishing and launched a number of initiatives and debates in recent years.15–22 We are now

EDITORIAL 588

Editorial / International Journal of Surgery 9 (2011) 585–588

launching Best BETs within the IJS and hope that the surgical and scientific community will embrace this latest initiative. References 1. The Cochrane Collaboration. Preparing, maintaining and promoting the accessibility of systematic reviews of the effects of health care interventions. Available at: http://www.cochrane.org[accessed 24.07.2011]. 2. CEBM. Oxford centre for evidence based medicine. Available at: http://www. cebm.net[accessed 24.07.2011]. 3. BMJ Publishing Group. Clinical evidence. http://www.clinicalevidence.com [accessed 24.07.2011]. 4. Agha R, Cooper D, Muir G. The reporting quality of randomised controlled trials in surgery: a systematic review. Int J Surg 2007;5(6):413–22. 5. Mackway-Jones K, Carley CD, Morton RJ, Donnan S. The best evidence topic report: a modified CAT for summarizing the available evidence in emergency medicine. J Accid Emerg Med 1998;15:222–6. 6. Mackway-Jones K. Towards evidence based emergency medicine: best BETs from the Manchester Royal Infirmary. Emerg Med J 2002;19:270–5. 7. Phillips B. Towards evidence-based medicine for paediatricians. Arch Dis Child 2002;87:258–62. 8. Dunning J, Prendergast B, Mackway-Jones K. Towards evidence-based medicine in cardiothoracic surgery: best BETS. Interact Cardiovasc Thorac Surg 2003;2: 405–9. 9. Mackway-Jones K, Carley CD. Bestbets.org: odds on favourite for evidence in emergency medicine reaches the world wide web. J Accid Emerg Med 2000; 17:235–6. 10. Mylona F, Preece J, Omosigho C, Willey C, Williamson A, Das G, et al. What’s the use of Archimedes? Arch Dis Child 2002;87:168–9. 11. Greenhalgh T. How to read a paper: the Medline database. Br Med J 1997;315: 180–3. 12. Mackway-Jones K, Carley CD, Morton RJ. Best BETs critical appraisal worksheets. http://www.bestbets.org/cgi-bin[accessed 24.07.2011]. 13. Greenhalgh T. How to read a paper: the basics of evidence based medicine. London: BMJ Publishing Group; 1997. 14. Crombie IG. The pocket guide to critical appraisal. London: BMJ Publishing Group; 1996. 15. Agha R. Introducing Wikisurgery.com: the blueprint for a surgical architecture of participation. Int J Surg 2006;4:140–3. 16. Agha R. Introducing the IJS.com: transforming an international audience into a global community. Int J Surg 2006;4:137–9. 17. Agha R, Rosin DR. Time for a new approach to case reports. Int J Surg 2010;8: 330–2.

18. Afifi RY, Agha R, Rosin D. Is research ethics committee approval necessary for publication of prospective surgical research studies? Int J Surg 2009;7:180–1. 19. Rosin D, Fitzgerald E, Agha R. The affiliation of the IJS and ASiT – two organisations at a crossroads. Int J Surg 2009;7:407–8. 20. Talati J, Agha R, Norcini Dr John. A pioneer in the field of medical education joins the IJS executive committee. Int J Surg 2009;7:488–9. 21. Agha R. The IJS and the COPE seminar 2006. Int J Surg 2006;4:80–1. 22. Agha R, Cooper DKC. The IJS welcomes two great pioneers. Int J Surg 2006;4: 7–8.

Omar A. Khan* Department of Surgery, Queen Alexandra Hospital, Portsmouth, UK Joel Dunning Department of Cardiothoracic Surgery, James Cook University Hospital, Middlesbrough, UK Amjad C. Parvaiz Department of Surgery, Queen Alexandra Hospital, Portsmouth, UK Riaz Agha Department of Plastic Surgery, Queen Victoria Hospital NHS Foundation Trust, East Grinstead, UK National Institute of Health and Clinical Excellence Scholar, London, UK David Rosin Department of Surgery, Queen Elizabeth Hospital, Bridgetown, Barbados Kevin Mackway-Jones Centre for Effective Emergency Care, Manchester Royal Infirmary, Manchester, UK * Corresponding author. Tel./fax: +44 2392286000. E-mail address: [email protected] Available online 9 August 2011