I wish I had written that paper

I wish I had written that paper Sudeep R Shah Consultant GI, HPB & Liver Transplant Surgeon PD Hinduja Hospital, Mumbai 400 016

The I word Personal Philosophical

Why do people write papers??????????

Compulsion Thesis Academic progression

Academic arrogance

To discover the truth

Who reveals the true path to us?

Do we believe... Our teachers? Our peers? Textbooks? Peer reviewed publications?

A lot of papers may not show us the truth

Data snooping bias Selection bias Reporting bias BIAS BIAS BIAS BIAS Observer bias Performance bias

We may not want to accept the truth

The good study Not only is it not biased it is seen to be not biased

Problems of the surgical study Exponential increase of new procedures Skill-dependency of surgery - uniformity Patient perception of ʻbestʼ choice Patient protection Consent Blinding

Articles Randomised, prospective, single-blind comparison of laparoscopic versus small-incision cholecystectomy A W Majeed, G Troy, J P Nicholl, A Smythe, M W R Reed, C J Stoddard, J Peacock, A G Johnson Departments of Surgical and Anaesthetic Sciences (A W Majeed MD, G Troy SRN, A Smythe MSc, M W R Reed MD, C J Stoddard MD, J Peacock FRCA, Prof A G Johnson MChir), and Sheffield Centre for Health and Related Research, University of Sheffield, Sheffield, UK (J P Nicholl PhD) Correspondence to: Mr A W Majeed, Department of Surgical and Anaesthetic Sciences, K--Floor, Royal Hallamshire Hospital, Sheffield S10 2JF, UK

popular despite early These concerns were later confirmed by a rise safety.4 common bile-duct injury and other injuries not hitherto associated with cholecystectomy. S Such complications prompted calls for careful evaluation of laparoscopic cholecystectomy6 as well as the establishment of training programmes in the new technique. Unfortunately, many surgeons deemed such evaluation as "ethically unjustified" and "very difficult if not impossible to conduct" due to the "obvious advantages" of the laparoscopic procedure.7,11 Investment by instrument manufacturers in new laparoscopic instruments and imaging systems may have helped establish these new techniques as part of surgical practice before safety and cost-effectiveness had been established.9 Indeed, when in

laparoscopic cholecystectomy. Trials which have been published since - 2 do not take account of the effect of beliefs of patients and carers which may have affected the results. We did a prospective, randomised, single-blind trial comparing laparoscopic and small-incision cholecystectomy in which we have minimised bias by standardising the two procedures and blinding patients and their carers during the preoperative and early postoperative period.

Postoperative protocol Post-operative pain relief was with a patient-controlled analgesic system delivering morphine. There was no restriction of oral intake of fluids or solids postoperatively. Patients were told that they could get out of bed and go home as soon as they felt fit enough. This decision would not be affected by the physician s views except in the event of a complication. A letter to the patient s general practitioner was handed to the patient detailing the nature and purpose of the trial and specifically requesting the general practitioner not to influence the time off work or time back to full activity taken by the patient. All patients were encouraged to resume full activity as soon as they felt they were fit enough and were given no advice on how long they would expect to remain convalescent.

Participating surgeons Four surgeons operated on trial patients. They had previously been trained on simulators and had performed or assisted with at least 40 laparoscopic cholecystectomies each before embarking on the trial and were considered to be over the learning curve for both the laparoscopic and small-incision approaches. 13

Randomisation and record keeping To eliminate bias caused by preoperative expectation, patients were randomised by sealed envelope in the operating theatre after anaesthesia had commenced. After completion- of surgery, all details were recorded in a trial folder kept separate from the patient s notes. This was handed over to the nurse in charge of the ward and access to it was restricted to emergency situations only. The nursing Kardex and all other documents recorded each operation as a trial cholecystectomy without specifying the access route.

protocol by patient regarding Figure 1: Postoperative dressings

Outpatient review Patients were interviewed in the outpatient clinic 3 weeks after discharge by a research nurse who was unaware of the operation performed. Wounds were checked by the surgeon in a separate room. Postoperative questionnaires included the time taken off work for employed patients, or return to full activity for patients not in paid employment. If the patient had not returned to full activity or resumed work by the time of the outpatient review, a postal questionnaire was sent to them 8 weeks after the operation requesting this information and subsequently at 6 months if they still had not resumed full activity.

Analysis Trial size Trial size was determined with respect to operating time and postoperative hospital stay. Because an interim analysis was planned half-way through the study, a nominal significance level of a=0-03 was used instead of 0,05.15 For a 90% chance of detecting a difference of 1 night s stay in hospital using the Mann-Whitney U-test, 100 patients were needed in each group (assuming SD of 2 nights). This gives a power greater than 90% for detecting a difference in operating times of 15 minutes, assuming a SD of 20 min. Statistics Principal comparisons were made on an intention-totreat basis. Quantitative outcomes were compared by the Mann- Whitney U-test. The curious result that although medians and ranges for time to first solid/semi-solid feed were the same in the two groups, the Mann-Whitney p-value was 0-03, was checked using a permutation test for the difference in mean times!6 which yielded the same result. Differences between groups in American Society of Anaesthesiologists (ASA) grades, proportions employed, and proportions with complications were compared using Pearson s X2 or Fisher s exact test as appropriate. Differences between ASA grades and hospital stay were tested using the Kruskal-Wallis one-way ANOVA. The dependence of operating time, and the length of incision in the small-incision cholecystectomy group on body mass index (BMI) was assessed by simple linear regression.

RESULTS

*x2 p>0.05. Table 4: Complications

Conclusions This study shows that a prospective randomised trial of laparoscopic cholecystectomy can be done and that it is possible to eliminate bias for or against the procedure from carers and patients. Once such bias is removed, we found that laparoscopic cholecystectomy takes longer to do and offers no benefit over small-incision cholecystectomy in terms of postoperative recovery, hospital stay, and time back to work or full activity. Because operating time is the only parameter which is different between the groups, it could be concluded that laparoscopic cholecystectomy is more expensive. However, actual costs will vary with individual operating theatre practices. We believe that, due to the small number of refusals, our results may be applicable to all patients suitable for elective cholecystectomy.

Laparoscopic versus small-incision cholecystectomy for patients with symptomatic cholecystolithiasis (Review) Keus F, de Jong J, Gooszen HG, van Laarhoven CHJM This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2009, Issue 4 http://www.thecochranelibrary.com

Authors conclusions Laparoscopic and small-incision cholecystectomy seem to be equivalent. No differences could be observed in mortality, complications, and postoperative recovery. Small-incision cholecystectomy has a significantly shorter operative time. Complications in elective cholecystectomy are prevalent.

Analysis 4.11. Comparison 4 LC versus SIC - high-quality and low-quality trials regarding follow-up, Outcome 11 Convalescence: normal activity (at home) (days). Review: Laparoscopic versus small-incision cholecystectomy for patients with symptomatic cholecystolithiasis Comparison: 4 LC versus SIC - high-quality and low-quality trials regarding follow-up Outcome: 11 Convalescence: normal activity (at home) (days) Study or subgroup Laparoscopic (LC) Small-incision (SIC) Mean Difference Weight Mean Difference 1High-qualitytrials N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI Barkun 1992 37 11.9 (9.1) 25 20.2 (16.5) 12.6 % -8.30 [ -15.40, -1.20 ] Majeed 1996 100 30.1 (26.6) 100 25.2 (13.3) 16.3 % 4.90 [ -0.93, 10.73 ] Ros 2001 362 8.6 (7.7) 362 10.7 (7.2) 38.4 % -2.10 [ -3.19, -1.01 ] Secco 2002 86 12.2 (7) 86 16.6 (8.5) 32.7 % -4.40 [ -6.73, -2.07 ] Subtotal (95% CI) 585 573 100.0 % -2.50 [ -5.54, 0.55 ] Heterogeneity: Tau 2 =5.96;Chi 2 =11.81,df=3(P=0.01);I 2 =75% Test for overall effect: Z = 1.61 (P = 0.11) 2Low-qualitytrials Subtotal (95% CI) 0 0 0.0 % 0.0 [ 0.0, 0.0 ] Heterogeneity: not applicable Test for overall effect: not applicable Total (95% CI) 585 573 100.0 % -2.50 [ -5.54, 0.55 ] Heterogeneity: Tau 2 =5.96;Chi 2 =11.81,df=3(P=0.01);I 2 =75% Test for overall effect: Z = 1.61 (P = 0.11) -10-5 0 5 10 Favours LC Favours SIC

The I word Personal Philosophical

Has anyone stopped lap cholecystectomy?? NO We are getting quicker and better So what if patients recover faster ONLY because they feel the procedure is laparoscopic... as long as they are recovering faster!!!!!

The beauty of EBM EBM is the use of mathematical estimates of the risk of benefit and harm derived from high quality research on population samples to inform on clinical decision making in individual patients

A simple observation McBride, Lancet 1962 A letter Saved 1000s

A simple idea Sethi PK. A rubber foot for amputees in underdeveloped countries. J Bone Joint Surg [Br] 1972;54-B:177 8. Millions fitted Superior to the SACH (solid ankle cushioned heel) foot Affordable Jaipur foot

Lateral thinking Local benefit Enable squatting Durability Cost Applicability to change millions of lives

The ideal paper I wish I had written EBM? A simple observation or idea? Any matter that tells the TRUTH advancing patient care advancing basic science