Background
Evaluation of new surgical procedures is a complex process challenged by evolution of technique, operator learning curves, the possibility of variable procedural quality, and strong ...treatment preferences among patients and clinicians. Preliminary studies that address these issues are needed to prepare for a successful randomized trial. The IDEAL (Idea, Development, Exploration, Assessment and Long‐term follow‐up) Framework and Recommendations provide an integrated step‐by‐step evaluation pathway that can help investigators achieve this.
Methods
A practical guide was developed for investigators evaluating new surgical interventions in the earlier phases before a randomized trial (corresponding to stages 1, 2a and 2b of the IDEAL Framework). The examples and practical tips included were chosen and agreed upon by consensus among authors with experience either in designing and conducting IDEAL format studies, or in helping others to design such studies. They address the most common challenges encountered by authors attempting to follow the IDEAL Recommendations.
Results
A decision aid has been created to help identify the IDEAL stage of an innovation from literature reports, with advice on how to design and report the IDEAL study formats discussed, along with the ethical and scientific rationale for specific recommendations.
Conclusion
The guide helps readers and researchers to understand and implement the IDEAL Framework and Recommendations to improve the quality of evidence supporting surgical innovation.
How to use IDEAL
Summary
Background
The preferred initial investigation with either magnetic resonance (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP) in patients with suspected biliary obstruction ...remains controversial in many clinical settings.
Aim
To assess the effectiveness of an initial MRCP vs. ERCP in the work‐up of patients at moderate likelihood of a suspected biliary obstruction.
Methods
Patients with an unconfirmed benign biliary obstruction, based on laboratory and ultrasound findings, were randomised to an ERCP‐first or MRCP‐first strategy, stratified by level of obstruction. The primary outcome was the occurrence of a disease or procedure‐related bilio‐pancreatic adverse events within the next 12 months. Secondary outcomes were the number of subsequent bilio‐pancreatic procedures, duration of hospitalisation, days away from activities of daily living (ADL), quality of life (SF‐36) and mortality.
Results
We randomised 126 patients to ERCP‐first and 131 to MRCP‐first (age 54 ± 18 years, 62% female, 39% post‐cholecystectomy). In follow‐up, 18/126 (14.3%) ERCP‐first and 25/131 (19.1%) MRCP‐first patients experienced a procedure‐ or disease‐related complication (P = 0.30) (disease‐related in 13 and 18 patients, and procedure‐related in 5 and 7 patients respectively). A cause of biliary obstruction was found in 39.7% vs. 49.6% of patients (P = 0.11). Sixty‐six (50%) patients in the MRCP‐first group ended up avoiding an ERCP in follow‐up. ERCP‐first and MRCP‐first patients were away from usual activities for 3.4 ± 7.7 days and 2.0 ± 4.8 days respectively (P < 0.001).
Conclusion
A strategy of MRCP‐first decreased the need for subsequent MRCPs, but not complications. Further study is required to define factors influencing the eventual use of MRCP vs. ERCP in appropriately selected patients (ClinicalTrial.gov: NCT01424657).
The IDEAL framework describes the stages of evaluation for surgical innovations. This paper considers the role of observational studies in the exploration and assessment stages. At the exploration ...stage, the surgical intervention is usually more widely used, and observational studies should collect prospective data from multiple surgeons, deal with factors such as case mix and learning, and prepare for a definitive evaluation at the next stage of assessment. Although a randomised controlled trial is preferable, a high quality observational study would be acceptable if a randomised trial is not feasible or, on rare occasions, deemed unnecessary.
Many men with inguinal hernia have minimal symptoms. Whether deferring surgical repair is a safe and acceptable option has not been assessed.
To compare pain and the physical component score (PCS) of ...the Short Form-36 Version 2 survey at 2 years in men with minimally symptomatic inguinal hernias treated with watchful waiting or surgical repair.
Randomized trial conducted January 1, 1999, through December 31, 2004, at 5 North American centers and enrolling 720 men (364 watchful waiting, 356 surgical repair) followed up for 2 to 4.5 years.
Watchful-waiting patients were followed up at 6 months and annually and watched for hernia symptoms; repair patients received standard open tension-free repair and were followed up at 3 and 6 months and annually.
Pain and discomfort interfering with usual activities at 2 years and change in PCS from baseline to 2 years. Secondary outcomes were complications, patient-reported pain, functional status, activity levels, and satisfaction with care.
Primary intention-to-treat outcomes were similar at 2 years for watchful waiting vs surgical repair: pain limiting activities (5.1% vs 2.2%, respectively; P = .06 corrected); PCS (improvement over baseline, 0.29 points vs 0.13 points; P = .79). Twenty-three percent of patients assigned to watchful waiting crossed over to receive surgical repair (increase in hernia-related pain was the most common reason offered); 17% assigned to receive repair crossed over to watchful waiting. Self-reported pain in watchful-waiting patients crossing over improved after repair. Occurrence of postoperative hernia-related complications was similar in patients who received repair as assigned and in watchful-waiting patients who crossed over. One watchful-waiting patient (0.3%) experienced acute hernia incarceration without strangulation within 2 years; a second had acute incarceration with bowel obstruction at 4 years, with a frequency of 1.8/1000 patient-years inclusive of patients followed up for as long as 4.5 years.
Watchful waiting is an acceptable option for men with minimally symptomatic inguinal hernias. Delaying surgical repair until symptoms increase is safe because acute hernia incarcerations occur rarely.Clinical Trials Registration ClinicalTrials.gov Identifier: NCT00263250.
Laparoscopic cholecystectomy (LC) has gained wide acceptance for treatment of cholelithiasis in preference to open cholecystectomy, though it has not been formally compared with mini cholecystectomy ...(MC). We have compared these two techniques in a randomised trial. 70 patients with ultrasound-proven cholelithiasis were randomly allocated LC (38) or MC (32); 37 and 25, respectively, underwent the assigned procedure. The mean hospital stay (including 1 preoperative day) was significantly shorter in the LC than the MC group (median 3 interquartile range 2-3 vs 4 3-5, p=0·001) as was duration of convalescence (mean 11·9 SD 9·1 vs 20·2 16·5 days, p=0·04). The rate of return to normal activities was 1·77 times greater in the LC group than in the MC group (95% confidence interval 1·01-3·11, p=0·03). In regression analysis, the type of cholecystectomy done was the only variable significantly associated with the duration of convalescence. Although there was significant postoperative improvement in all of three quality of life scores in both groups, LC patients improved more quickly than did MC patients. This randomised trial shows the superior effectiveness of LC over MC in treating cholelithiasis.
Summary
Background: Uninvestigated dyspepsia is common in family practice. The prevalence of clinically significant upper gastrointestinal findings (CSFs) in adult uninvestigated dyspepsia patients, ...and their predictability based on history, is unknown.
Methods: Prompt endoscopy was performed within 10 days of referral, in 1040 adult patients presenting with uninvestigated dyspepsia at 49 Canadian family practitioner centres. Subsequent management strategies during a 6‐month follow‐up period were determined by the individual family practitioners.
Results: CSFs were identified in 58% (603/1040) of patients. Erosive oesophagitis was most common (43%; N = 451); peptic ulcer was uncommon (5.3%; N = 55). Alarm symptoms were uncommon (2.8%; N = 29). Most patients had at least three dyspepsia symptoms, more than 80% had at least six, and approximately half had eight or more. Based on the dominant symptom, 463 (45%) patients had ulcer‐like, 393 (38%) had reflux‐like and 184 (18%) had dysmotility‐like dyspepsia. The patients' dominant symptom was not predictive of endoscopic findings. Oesophagitis was more common in those with dominant reflux‐like symptoms and was the most common finding in all subgroups. The prevalence of gastroduodenal findings was similar in all symptom subgroups. Helicobacter pylori (H. pylori) infection (30%; 301/1013) was associated with gastroduodenal findings.
Conclusions: Dyspepsia subclassifications, based on dominant symptom, are of limited value in predicting the presence and nature of CSFs. Oesophagitis was by far the most common diagnosis (43% of patients). CSFs were common in uninvestigated dyspepsia patients and their nature suggests patients could be initially treated effectively, without endoscopy, using empirical acid suppressive therapy.
Background: Interest in the training and evaluation of laparoscopic skills is extending beyond the realm of the operating room to the use of laparoscopic simulators. The purpose of this study was to ...develop a series of structured tasks to objectively measure laparoscopic skills. This model was then used to test for the effects of level of training and practice on performance.
Methods: Forty-two subjects (6 each of surgical residents PGY1 to PGY5, 6 surgeons who practice laparoscopy and 6 who do not) were evaluated. Each subject viewed a 20-minute introductory video, then was tested performing 7 laparoscopic tasks (peg transfers, pattern cutting, clip and divide, endolooping, mesh placement and fixation, suturing with intracorporeal or extracorporeal knots). Performance was measured using a scoring system rewarding precision and speed. Each candidate repeated all 7 tasks and was rescored. Data were analyzed by linear regression to assess the relationship of performance with level of residency training for each task, and by ANOVA with repeated measures to test for effects of level of training, of repetition, and of the interaction between level of training and repetition on overall performance. Student’s
t test was used to evaluate differences between laparoscopic and nonlaparoscopic surgeons and between each of these groups and the PGY 5 level of surgical residents.
Results: Significant predictors of overall performance were (a) level of training (
P = 0.002), (b) repetition (
P < 0.0001), and (c) interaction between level of training and practice (
P = 0.001). There was also a significant interaction between level of training and the specific task on performance scores (
P = 0.006). When each task was evaluated individually for the 30 residents, 4 of the 7 tasks (tasks 1, 2, 6, 7) showed significant correlation between PGY level and score. A significant difference in performance scores between laparoscopic and nonlaparoscopic surgeons was seen for tasks 1, 2, and 6.
Conclusions: A model was developed to evaluate laparoscopic skills. Construct validity was demonstrated by measuring significant improvement in performance with increasing residency training, and with practice. Further validation will require correlation of performance in the model with skill in vivo.
Summary
Background Currently there is no consensus on the optimal method to measure the severity of dyspepsia symptoms in clinical trials.
Aim To validate the 7‐point Global Overall Symptom scale.
...Methods The Global Overall Symptom scale uses a 7‐point Likert scale ranging from 1 = no problem to 7 = a very severe problem. Validation was performed in two randomized‐controlled trials (n = 1121 and 512). Construct validity: Global Overall Symptom was compared with the Quality of Life in Reflux And Dyspepsia, Gastrointestinal Symptom Rating Scale, Reflux Disease Questionnaire and 10 specific symptoms using Spearman correlation coefficients. Test–retest reliability: The Intraclass Correlation Coefficient was calculated for patients with stable dyspepsia defined by no change in Overall Treatment Effect score over two visits. Responsiveness: effect size and standardized response mean were also calculated.
Results Construct validity: Change in Global Overall Symptom score correlated significantly with Quality of Life for Reflux And Dyspepsia, Gastrointestinal Symptom Rating Scale, Reflux Disease Questionnaire and specific symptoms (all P < 0.0002). Reliability: The Intraclass Correlation Coefficient was 0.62 (n = 205) and 0.42 (n = 270). Responsiveness: There was a positive correlation between change in Global Overall Symptom and change in symptom severity. The effect size and standardized response mean were 1.1 and 2.1, respectively.
Conclusion The Global Overall Symptom scale is a simple, valid outcome measure for dyspepsia treatment trials.
Background: The management of bile leaks has evolved in the laparoscopic era. This study characterizes risk factors for their development and their clinical course and management. Methods: Data on a ...cohort of patients who developed bile leaks after cholecystectomy in the laparoscopic era were gathered prospectively and retrospectively from an ongoing surgical database and following a review of hospital charts. Results: Sixty-four patients (mean age 56 ± 17.1 years, 72% women) were included over a 5-year study period. The incidence of leaks was 1.1% among patients entered in a laparoscopic cholecystectomy database. Intraoperative complications were encountered in 36%. Rates of intraoperative complication and conversion to open surgery were greater among patients who developed leaks (5.2% vs 0.6% and 33% vs 6.3%, respectively, p < 0.00001). Patients presented 5.3 ± 4.2 days following surgery with abdominal pain (89%), fever (74%), and tenderness (81%). Ultrasound diagnosed a suspected leak in 73%, which ERCP showed as originating from the cystic duct stump in 77%. Biliary obstruction was noted in 20 (31%) patients (14 with stones). Treatments included percutaneous (13%), endoscopic (28%), primary or secondary operative procedures (14%), or a combination thereof (45%). Conclusion: A complication at laparoscopic cholecystectomy increases the likelihood of a subsequent bile leak. Most patients present early with a patent cystic duct stump in the absence of biliary obstruction. Endoscopic therapy is successful in the majority of cases, but otherwise percutaneous or operative procedures may be needed. (Gastrointest Endosc 1997;45:277-82.)
Based on the excellent correlation between cyclosporine A 2-hr postdose blood levels (C2) and the area under the concentration versus time curve, we evaluated the clinical benefit of Neoral dose ...monitoring with C2 compared trough levels (C0) in stable heart transplant patients.
We studied 114 stable adult patients followed at the heart transplant clinic, who were >1 year after surgery. In May 1996 (period 1, follow-up 10+/-4 months), Neoral dose monitoring was based on C2 (300-600 ng/ml); while in May 1997 (period 2, follow-up 10+/-2 months), it was based on C0 (100-200 ng/ml). Cyclosporine A levels were measured by an enzyme multiplied immunologic technique. Clinical benefit was defined by the absence of acute rejection, no mortality, no fall in left ventricular ejection fraction >10%, and no increase in serum creatinine >10% (compared with baseline).
During period 1, Neoral dose, cyclosporine A, C0 and C2, and serum creatinine, decreased by 26, 56, 45, and 2.3%, respectively. At the end of period 2, the same variables increased by 24, 56, 38, and 10%, respectively (P<0.0001). The incidence of acute rejection was similar (period 1: 0.87%, period 2: 0.96%). The left ventricular ejection fraction (initial/final) remained stable (period 1: 57+/-91%/58+/-13%, period 2: 59+/-11d/58+/-10%). Mortality did not differ (period 1: 7.9%, period 2: 9.6%). A clinical benefit was observed in 69.3% of the patients during period 1 vs. 43.3% of the patients during period 2 (P<0.00001).
In stable heart transplant patients, a greater clinical benefit was observed when Neoral dose monitoring was performed according to C2, compared with C0.
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