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Simulator training improves practical skills in therapeutic GI endoscopy: results from a randomized, blinded, controlled study
ORIGINAL ARTICLE: Clinical Endoscopy
Simulator training improves practical skills in therapeutic GI endoscopy: results from a randomized, blinded, controlled study Adam V. Haycock, MRCP, Philippa Youd, MRCP, Paul Bassett, Brian P. Saunders, MD, MRCP, Paris Tekkis, MD, FRCS, Siwan Thomas-Gibson, MD, MRCP London, United Kingdom
Background: Therapeutic endoscopic procedures are technically challenging and have higher complication rates than diagnostic procedures. Less-experienced practitioners are significantly more likely to have a complication, yet there is very limited evidence of the efficacy of training in such procedures. Objective: To evaluate the effect of knowledge-based teaching and hands-on, simulation-based skills training in 4 therapeutic endoscopic procedures: control of nonvariceal upper GI bleeding, polypectomy, stricture dilation, and percutaneous endoscopic gastrostomy (PEG) tube insertion. Design: Single-blind, randomized, controlled trial. Setting: Nationally accredited therapeutic endoscopy course. Participants and Intervention: Participants were randomized into groups to assess the effect of knowledgebased teaching and into subjects or controls to assess skills-based training. All delegates had an initial knowledge and skills assessment by blinded experts. Subjects received one-half day of hands-on skills training, whereas the controls did not. All delegates were retested on their procedural skills. Main Outcome Measurements: Knowledge was assessed by using a multiple-choice questionnaire. Practical skills were assessed using station-specific checklists and a global score. Results: Twenty-eight participants were randomized. There was no significant effect of knowledge-based teaching on the participants’ practical skills or initial multiple-choice questionnaire score, although there was a trend toward improvement. There was a significant improvement in the subjects compared with the controls in the performance of polypectomy, control of upper GI bleeding, and esophageal dilation. There were no significant differences for PEG tube insertion. Limitations: The 2-person nature of PEG tube insertion may have resulted in performance improvement despite a lack of training. Conclusion: Hands-on skills training significantly improved performance in 3 therapeutic modalities. Knowledge-based teaching alone did not have a measurable effect. These results strongly support the benefit of intensive hands-on, simulation-based courses for endoscopic skills training. (Gastrointest Endosc 2009;70:835-45.)
Copyright ª 2009 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 doi:10.1016/j.gie.2009.01.001
significantly more likely to encounter a complication than more experienced endoscopists.3-5 Trainee endoscopists require supervised hands-on experience to develop competence in safe procedure performance, but training in therapeutic endoscopy can be difficult to obtain.6-8 The American Society for Gastrointestinal Endoscopy state that short courses ‘‘should not be considered a substitute for training acquired during a formal residency/fellowship in an accredited training program’’9; however, the ability to practice therapeutic techniques on endoscopic simulators without associated risks to the patient early on in training would be advantageous.
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Therapeutic endoscopic procedures are technically challenging and have higher complication rates than diagnostic procedures.1,2 Less-experienced practitioners are Abbreviations: GS, global score; MCQ, multiple-choice questionnaire; PEG, percutaneous endoscopic gastrostomy; UGIB, upper GI bleeding; UK, United Kingdom. DISCLOSURE: All authors disclosed no financial relationships relevant to this publication.
Simulator training improves practical skills in therapeutic GI endoscopy
The European Society of Gastrointestinal Endoscopy has recommended that simulators, where available, should be used for training in GI endoscopy,10 and there is evidence that practice using endoscopy simulators can improve technical skills in endoscopic hemostasis.11-15 There is, however, no published literature regarding training in other therapeutic skills such as polypectomy, stricture dilation, and percutaneous endoscopic gastrostomy (PEG) tube insertion. Completion of a basic therapeutic endoscopy course is now recommended for all trainees wishing to become accredited in endoscopy in the United Kingdom (UK).16 The aim of this study was to evaluate the effect of knowledge-based teaching and hands-on skills training in 4 therapeutic endoscopic techniques: control of nonvariceal upper GI bleeding (UGIB), polypectomy, stricture dilation, and PEG tube insertion. The study used a singleblind, randomized, controlled trial to assess knowledge acquisition and change in practical skill.
Haycock et al
Capsule Summary What is already known on this topic d
Therapeutic endoscopy is technically challenging and has higher complication rates. Training on simulators improves technical skills in controlling of nonvariceal hemorrhage.
What this study adds to our knowledge d
In a single-blind trial of 26 randomized endoscopists, structured simulation-based training objectively improved technical skills in polypectomy, control of nonvariceal hemorrhage, and esophageal stricture dilation, whereas knowledge-based lectures alone did not.
A questionnaire was completed by all the participants to provide data on demographics, previous endoscopic experience, previous therapeutic procedures, selfreported measures of competence and confidence in ther-
apeutic endoscopy, and expectations regarding the training outcomes of the course. All participants were given four 40-minute lectures designed to present the knowledge base underlying safe therapeutic endoscopy. This forms a vital part of training and may have an impact on the skills performance on the simulators. To test for the effect of this knowledgebased teaching, participants were randomized to receive either the lectures first and then assessments of knowledge and practical skills (group 1) or the assessments first and then the lectures (group 2). Randomization was done by using a computer-generated block allocation protocol with 8 per block. The participants’ knowledge was assessed by using a multiple-choice questionnaire (MCQ) containing truefalse questions on all 4 modalities of therapeutic endoscopy. Participants’ procedural skills were assessed on each of the 4 therapeutic simulations. Nonvariceal hemostasis, snare polypectomy, and PEG tube insertion were performed on ex vivo models (Erlangen Endo Trainer; ECE-Training GmbH, Erlangen, Germany); esophageal stricture dilation was performed on a modified mechanical upper GI phantom (Adam; Rouilly Ltd, Kent, UK). The participants were given 10 minutes to complete each task to the best of their ability with an endoscopy assistant who would follow instructions competently, but would not offer instruction or be otherwise proactive. An expert observer and the endoscopy assistant assessed each participant. Both were blinded to the group allocation of participants. Specific skills tested were the use of injection, endoclips, and a bipolar diathermy probe for nonvariceal hemostasis; the technique for snare polypectomy and hot biopsy; manipulation of the endoscope for PEG tube insertion; and the technique for balloon dilation of an esophageal stricture. The subjects then received four 30-minute standardized practical hands-on skills training sessions on each therapeutic simulator taught by experienced endoscopists
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PATIENTS AND METHODS This was a prospective educational evaluation study performed at a single institution (academic endoscopy unit and national training center). The study was approved by our institutional review board and the Harrow ethics committee (07/H0719/52). Participants were drawn from a cohort of endoscopists who had already expressed an interest in attending the course, as well as from applications received in response to advertisements on 3 training-related websites and an e-mail to all gastroenterology trainees in the UK. Participants were eligible for inclusion if they had not previously attended a therapeutic endoscopy course, were currently exposed to at least 3 of the 4 therapeutic procedures, and would expect to continue being exposed to these therapeutic techniques after the course. Participants were excluded if they were already rated as being able to independently perform more than 2 of the 4 therapeutic procedures safely. The participants were recruited in 2 blocks of 16, with the study being run during 2 blocks of 3 days in September 2007 and April 2008. They were enrolled by the lead investigator and then randomized into subjects and controls by using a computer-generated block randomization protocol with 8 per block. Participants were informed of their allocation and the dates of the study intervention by the lead investigator; thus, neither was blinded to the group allocation.
Interventions
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Simulator training improves practical skills in therapeutic GI endoscopy
Statistical analysis
Figure 1. Summary of the study design.
and senior endoscopy assistants in a one-to-one ratio. The control group was not given any skills training. Both the subjects and controls then had a reassessment of their practical skills on each simulator in a fashion identical to that of the initial assessment. After completion of the study, the control group received training identical to that received by the subject group (see Figure 1 for summary of the study design).
Main Outcome Measurements The knowledge-based outcome measure was the score obtained on the MCQ (maximum score, 97). The skillsbased outcome measures were station-specific checklists and a modified global rating scale17 termed a global score (GS) (Appendix 1), which assessed competence against previously defined levels taken from the UK national endoscopy competence framework.18 The expert observer completed both the checklist and GS, and the endoscopy assistant completed only the GS. Each checklist contained nodal stops, which were considered to be essential for the safe completion of the procedure. Failure to perform a nodal stop satisfactorily incurred a penalty of 3 points. The final checklist score was calculated as the sum of the completed checklist steps and penalty points. The total score was calculated as the sum of the final checklist score, the instructor GS, and the assistant GS. The primary endpoints were the difference in the MCQ score between the groups and the change in the skills assessment score from initial assessment to reassessment. Secondary endpoints were changes in the individual checklist scores; the GS and a subset of the GS, which was the experts’ rating of competence on a 5-point categorical scale. The data from the questionnaire were correlated with feedback forms completed after the end of the course. www.giejournal.org
The primary aim of the study was to examine the change in score between the initial skills assessment and the reassessment. When using the GS as the primary measure, a difference of 3 units in a score was considered of clinical importance, and it was estimated that the withinsubject standard deviation would be 4 units. With 5% significance and 80% power, 14 participants were required for the subject group, with an equivalent number for the control group, to detect a similar size difference over time. To allow for some dropout of participants and errors in data collection, recruitment aimed at enrolling a total of 32 participants in the study in 2 blocks of 16 participants. Statistical analysis was performed on an intent-to-treat basis. For the outcomes that were measured on a categorical scale, Fisher’s exact test was used to compare the results between the groups. For continuous measurements that were found to be non-normally distributed, the Mann-Whitney U test was used to compare variables between groups. For continuous measurements that were normally distributed, unpaired t tests were used to compare variables between groups, and paired t tests were used to compare changes within groups over time.
RESULTS Study participants Eighty-nine candidates expressed an interest in attending the course and were considered for inclusion in the study. Four did not meet eligibility criteria, and 57 were excluded because of an inability to get study leave or funding. Twenty-eight participants who met the eligibility criteria were randomized, with 26 completing the study. One subject did not receive the training because of illness, and one control had to leave for personal reasons before the final assessments (see Figure 2 for flow diagram of participants through each stage of the study). There was a spread of experience across the first 4 training years (4 first year, 6 second year, 4 third year, 4 fourth year) and 7 endoscopists currently not in training posts. All had current endoscopy exposure as described in the inclusion criteria. The subjects and controls were well matched with no significant differences in the demographics (Table 1) or previous endoscopy experience (Table 2). They were also well matched in their initial skills assessment scores, with only the UGIB checklist score showing that the subjects performed significantly better than controls (Table 3). This means that the subjects had a lower chance of improvement on this measure when comparing initial and final scores, which will bias against the subjects.
Expectations of trainees The expectations of trainees for the course were high, with an overall precourse expectation of 8.2 out of 10 on Volume 70, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY 837
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Figure 2. Flow diagram of participants through each stage of the study.
TABLE 1. Demographics of participants Variable Sex
Handedness
Grade
Specialty
Group
No. (%) controls
No. (%) subjects
P value
11 (85)
11 (73)
.66
Female
2 (15)
4 (27)
Left
0 (0)
1 (7)
Right
13 (100)
14 (93)
Specialist registrar
10 (77)
11 (73)
Consultant/other
3 (23)
4 (27)
Gastroenterology
11 (85)
11 (73)
2 (15)
4 (27)
Yes
11 (85)
11 (67)
No
2 (15)
4 (27)
Male
Surgery UK trained
1.00
1.00
.66
.66
UK, United Kingdom.
a visual analog scale. Expectations of how useful the course would be, how appropriate the learning objectives were for them, and how well the course would meet those learning objectives were also high. They also expected the course to be highly enjoyable. Feedback after the course
showed that it met or exceeded all their expectations. Specific feedback for each element of the course was also exceptionally good, with an average score of 8.4 out of 10. The practical hands-on sessions were rated especially highly, with an average score of 8.9 out of 10.
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TABLE 2. Age and previous endoscopic experience of participants Controls, median (range) Subjects, median (range) P value Age (y)
32 (28-45)
33 (28-55)
.39
105 (5-400)
90 (18-500)
.78
Precourse endoscopy experience Colonoscopy Flexible sigmoidoscopy
70 (10-700)
80 (10-400)
.72
Polypectomy
20 (5-75)
20 (0-300)
.55
EGD
400 (75-4000)
Therapeutic EGD
.39
25 (0-50)
20 (2-100)
.93
2 (0-20)
1 (0-10)
.59
15 (0-50)
5 (0-30)
.20
Esophageal dilations PEG insertion
300 (100-1200)
PEG, Percutaneous endoscopic gastrostomy.
TABLE 3. Initial skills assessment scores for subjects and controls
Group Polypectomy
Dilation
UGIB
PEG
Variable
Controls, median (range)
Subjects, median (range)
P value
10 ( 3 to 18)
.98
Checklist score
8 (1-18)
No. nodal stops
1 (0-2)
0 (0-2)
.56
Instructor GS total
19 (6-27)
17 (7-27)
.28
Assistant GS total
18 (7-30)
16 (6-28)
.21
Overall total
47 (15-64)
42 (12-67)
.45
Checklist score
9 (4-14)
7 (0-14)
.44
No. nodal stops
0 (0-1)
1 (0-1)
.23
Instructor GS total
15 (9-27)
16 (6-23)
.87
Assistant GS total
17 (8-21)
16 (7-24)
.61
Overall total
43 (26-61)
38 (16-58)
.50
Checklist score
8 (1-13)
12 (4-16)
.04
No. nodal stops
0 (0-1)
0 (0-1)
.86
Instructor GS total
17 (6-23)
17 (11-24)
.71
Assistant GS total
16 (10-30)
18 (7-28)
.64
Overall total
40 (17-59)
47 (24-63)
.32
Checklist score
13 ( 2 to 18)
14 (4-18)
.89
0 (0-2)
0 (0-0)
.50
Instructor GS total
22 (7-29)
21 (6- 30)
.75
Assistant GS total
21 (7-30)
20 (6-30)
.46
Overall total
56 (14-76)
47 (17-76)
.60
No. nodal stops
GS, Global score; UGIB, upper GI bleeding; PEG, percutaneous endoscopic gastrostomy.
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TABLE 4. Initial skills assessment scores for those who had the lectures before assessment (group 1) and the group who had the lectures after the assessment (group 2) Group 1, median (range)
Group 2, median (range)
P value
Checklist score
13 (3-18)
10 (5-15)
.13
No. nodal stops
0.5 (0-2)
1 (0-2)
.52
Instructor GS total
19 (7-27)
17 (6-24)
.15
Assistant GS total
18 (8-30)
16 (6-28)
.40
Overall total
48 (12-67)
40 (15-59)
.08
Checklist score
12 (5-14)
11 (3-13)
.51
No. nodal stops
1 (0-1)
0.5 (0-1)
.25
Group Polypectomy
Dilation
UGIB
PEG
Variable
Instructor GS total
17 (6-27)
16 (9-23)
.91
Assistant GS total
17 (7-21)
16 (7-24)
1.00
Overall total
44 (21-61)
41 (16-58)
.76
Checklist score
12 (6-16)
9 (1-15)
.30
No. nodal stops
0 (0-1)
0 (0-1)
.15
Instructor GS total
18 (11-24)
17 (6-24)
.28
Assistant GS total
18 (7-25)
17 (10-30)
.58
Overall total
47 (24-63)
41 (17-61)
.57
Checklist score
15 (4-18)
13 (5-17)
.55
No. nodal stops
0 (0-2)
0 (0-1)
.96
Instructor GS total
24 (6-29)
20 (8-30)
.68
Assistant GS total
19 (6-28)
21 (7-30)
.30
Overall total
56 (14-75)
51 (19-76)
.75
GS, Global score; UGIB, upper GI bleeding; PEG, percutaneous endoscopic gastrostomy.
Effect of lectures
There was a significant difference in the final reassessment scores (Table 5) and the median change from baseline (Table 6) for nearly all assessment measures between subjects and controls. There were significant differences
between groups for the polypectomy measures, with only the number of nodal stops not showing a difference between groups. For each score, the subject group was more likely to have a greater increase than the control group. The results for the stricture dilation show statistically significant differences between subjects and controls for all measures, with the subject group improving their scores more than the control group, although the difference for assistant GS was only of borderline statistical significance. For control of UGIB, there was a significant difference in the checklist score, number of nodal stops, and overall score, but not in the GS. For the checklist score and overall total, the subject group was more likely to have a greater increase in scores than the control group, despite the fact that the subjects originally scored higher than the controls for the checklist score on this station. There was no difference in median values for the number of nodal stops between the two groups, but the range of values indicated that nodal stops were performed
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Although there was a trend toward higher scores in the skills assessment for the group that had the lectures before assessment (Group 1) than the group who had the lectures after the assessment (Group 2), there was no statistically significant effect of the lectures on the participants’ practical skills (Table 4). There was no significant difference found in the initial MCQ score. The average (standard deviation) scores for group 1 were 70.6 (7.1) and 65.5 (8.7) for group 2 (P Z .10), demonstrating no measurable effect of knowledge-based teaching when using a knowledge assessment.
Effect of hands-on skills training
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Simulator training improves practical skills in therapeutic GI endoscopy
TABLE 5. Final skills reassessment scores for subjects and controls
Group Polypectomy
Dilation
Variable
Subjects, median (range)
Checklist score
17 (14-19)
No. nodal stops
0 (0-1)
12.5 (2-19)
.011
0 (0-2)
.258
25 (16-30)
16.5 (9-24)
.001
Assistant GS total
26 (14-29)
19.5 (11-27)
.044
Overall total
67 (44-76)
48.5 (24-67)
.002
Checklist score
14 (8-15) 0 (0-1)
9 (0-13)
!.001
0.5 (0-1)
.067
21 (10-27)
.017
Instructor GS total
24 (15-30)
Assistant GS total
20 (13-30)
16.5 (9-22)
.174
Overall total
60 (36-75)
48.5 (22-61)
.005
Checklist score
17 (13-22)
8 (3-11)
!.0001
No. nodal stops
0 (0-1)
0 (0-1)
.142
23 (15-29)
18 (10-27)
.112
20 (7-29)
.051
Instructor GS total Assistant GS total
PEG
P value
Instructor GS total
No. nodal stops
UGIB
Controls, median (range)
24.5 (18-30)
Overall total
64 (53-75)
46 (24-65)
.001
Checklist score
18 (14-19)
16.5 (12-19)
.044
No. nodal stops
0 (0-0)
Instructor GS total
1.0
27.5 (21-30)
26 (11-29)
.077
26 (17-30)
26 (10-29)
.960
71.5 (52-79)
69 (33-74)
.129
Assistant GS total Overall total
0 (0-0)
GS, Global score; UGIB, upper GI bleeding; PEG, percutaneous endoscopic gastrostomy.
correctly more often by the subject group than the control group. There was no evidence of a difference between the groups for any of the measures for the insertion of a PEG tube. The change in overall score for each skill is shown in Figure 3.
Optimal patient care and outcomes of all types of endoscopic therapeutic procedures are highly dependent on the skill of the operator. How a trainee should safely and reliably gain this skill has frequently been debated. Traditionally, practical skills are gained by practicing on patients while being supervised by an expert, often over a prolonged period of time. Acquisition and refinement of the necessary cognitive and psychomotor skills inevitably result in performance errors by trainees, which may in turn result in poorer outcomes for patients. It may also be difficult for trainees to gain experience in uncommon, emergency, or difficult procedures. Surgeons have long
recognized that structured training with the use of simulators is advantageous for these types of procedures to be learned in a safe, controlled manner with no risk to patients.19,20 With increasing development of endoscope technology, GI endoscopy is becoming more and more focused on the provision of therapy within the GI tract. With the advent of natural orifice transluminal endoscopic surgery, endoscopists are looking to expand their skills extraluminally as well. As with all practical skills, there is a learning curve for these procedures, and the training issues that have concerned surgeons now equally apply to endoscopists. There are many different types of therapeutic endoscopy courses available, ranging from courses offering simple observation of procedures and courses providing hands-on practice by using endoscopy simulators to those offering supervised practice on real patients. Although lecturebased or observational courses may offer tips and tricks to aid self-improvement and have the ability to demonstrate advanced techniques without exposing patients to added risk, there is no evidence of their ability to alter
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DISCUSSION
Simulator training improves practical skills in therapeutic GI endoscopy
Haycock et al
TABLE 6. Change in score from initial skills assessment to reassessment for subjects and controls
Group Polypectomy
Dilation
UGIB
PEG
Variable
Controls, median (range)
Subjects, median (range)
P value
Checklist score
2 ( 7 to 9)
6 ( 2 to 15)
.03
No. nodal stops
0 ( 2 to 1)
0 ( 2 to 1)
.85
Instructor GS total
-2 ( 11 to 11)
7 (1-15)
Assistant GS total
-1 ( 12 to 8)
8 ( 8 to 16)
Overall total
-1 (-18 to 31)
21 (4-52)
Checklist score
2 ( 6 to 4)
3 (1-9)
No. nodal stops
0 ( 1 to 1)
1 ( 1 to 0)
.02
Instructor GS total
3 ( 4 to 11)
8 (1-14)
.02
Assistant GS total
2 ( 7 to 9)
6 ( 4 to 12)
.06
Overall total
3 ( 15 to 26)
Checklist score
!.001 .006 .002 !.001
18 (5-32)
.003
1 ( 7 to 6)
7 (2-11)
!.001
No. nodal stops
0 (0-1)
0 ( 1 to 0)
.02
Instructor GS total
3 ( 4 to 11)
6 ( 5 to 11)
.28
Assistant GS total
3 ( 7 to 11)
5 ( 2 to 14)
.18
Overall total
3 ( 5 to 25)
15 (3-32)
.004
Checklist score
4 (-3 to 12)
3 (0-12)
.68
No. nodal stops
0 ( 2 to 0)
0 (0-0)
.12
Instructor GS total
4 ( 3 to 16)
7 ( 5 to 22)
.24
Assistant GS total
3 (-2 to 18)
8 ( 4 to 13)
.28
12 ( 4 to 52)
19 ( 9 to 39)
.30
Overall total
GS, Global score; UGIB, upper GI bleeding; PEG, percutaneous endoscopic gastrostomy.
the actual skills of attendees. Practice on real patients may offer more expert training than is available at their home hospital, and there is some evidence that shows the long-term benefit of intensive hands-on courses in diagnostic colonoscopy.21 However, courses offering this type of training for therapeutics still run into all the problems of standard training methodologies in terms of limited exposure to procedures for trainees and risk of complications for patients. Courses based on simulation can provide an effective skills-training platform without any of these risks and with the many advantages of simulation such as repetition of procedures, predictability, and the use of real accessories. Computer simulations have been shown to be effective in the early phase of diagnostic endoscopic training,22,23 particularly for colonoscopy.24,25 However, they do not yet realistically simulate the tissue elasticity during therapeutic procedures, and there is as yet no evidence of their efficacy in this area. There is much more evidence of the use of ex vivo biosimulation models such as were used
in this evaluation. Ex vivo models have been shown to be effective in emergency endoscopy and crisis management skills training,26 ERCP,27,28 and endoscopic hemostasis.11-13,29
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Figure 3. Graph of change in overall score between initial assessment and reassessments for each therapeutic modality. Results are the interquartile range (range).
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Simulator training improves practical skills in therapeutic GI endoscopy
It is not surprising that they are effective because they allow repeated practice on realistic platforms. However, running such courses is expensive, requiring specific animal models that can be costly to purchase and maintain. The use of ex vivo models requires specialist facilities, often incurring extra location costs. The courses are also costly in terms of manpower and staff time, which must be factored into the charge passed on to participants. Evaluation of outcomes should form part of the quality assurance for such courses. This study is the first evaluation of a training course specifically tailored for the basic therapeutic skills required by independent practitioners. This evaluation demonstrated the effectiveness of intensive hands-on simulator training for improving practical skills in 3 different endoscopic therapeutic modalities. This extends the evidence of this type of training from purely endoscopic hemostasis to polypectomy and dilation in the GI tract. It is noteworthy that the training effect was measurable after a relatively short period (30 minutes) of one-on-one instruction. This study also shows that knowledge-based teaching alone does not have a measurable effect on performance, emphasizing the importance of specific hands-on training to improve the practical skills required. No measurable effect of structured skills training for insertion of a PEG tube was demonstrated. This may be because of the 2-person nature of the procedure. Unlike the other 3 modalities, in which the endoscopist performs the majority of the technical procedures and the assistant is in a helping mode, PEG tube insertion requires 2 operators of more equal skill. The endoscopist’s role is limited to examining the stomach and then snaring the string before withdrawal, which does not require either advanced hand skills or judgment. The majority of the technical aspects of the procedure (localizing the site, insertion of the trocha, assembly of the PEG tube) are performed by the assistant, who must be both knowledgeable and adequately trained in all aspects of the procedure. Both the assistant and the endoscopist have equal input in a successful insertion. The outcomes for this study were based on the change in performance of the endoscopist between two assessments. Both subjects and controls improved in all the scoring systems used, with a large range of scores measured. It is possible that the controls improved their performance merely by observation of a competent assistant during the initial assessment procedure. It may also be that the assessment tools used were additionally measuring the competence of the assistant, which may negate any deficiencies or competencies of the endoscopist. It may also be that this procedure is simpler to learn than the other therapeutic skills, and didactic learning may be enough to enhance performance without the need for hands-on training. The study did not show any effect of knowledge-based teaching by using a knowledge assessment. This is likely at-
tributable to weaknesses of the MCQ used for the assessment, which may not have reflected the lecture material closely enough. The validity of the skills assessment tools could also be questioned. Checklist scores and the GS form part of the objective structured assessment of technical skill format, which has previously been shown to be reliable and valid for use in assessment of surgical training.17,30-43 A checklist approach has also been successfully used in the assessment of hemostasis during simulated endoscopy.13 The polypectomy checklist has been previously validated,44 and the other checklists were created based on this format by the authors, but have not been validated individually. The GS was adapted from the surgical platform by the authors for therapeutic endoscopy, but not specifically validated. Further work is currently being performed to benchmark and assess the criterion validity of these tools as assessments of competency. Finally, there may also have been a performance effect attributable to differing motivations between the groups at the final assessment, with the subjects wanting to demonstrate their skill acquisition and the controls performing less well because of the frustration of repetitive testing. However, the subjects had no additional motivation to improve their performance, whereas the controls were still motivated by the expectation of subsequent training. The results from the PEG station also show that the controls did improve where there was the possibility of experiential learning. Although the results of this study show that hands-on skills training improves performance of simulated procedures, it does not provide evidence that such training translates into improved outcomes in clinical endoscopic practice. Follow-up of trainees’ performance in each modality over time by using standardized assessment tools would be necessary to show such an effect. One study showed that trainees receiving simulator as well as clinical training for hemostasis have a higher success rate and a decrease in the frequency of complications in their clinical practice compared with those who are just clinically trained.13 However, there are as yet no data showing clinical efficacy for the other therapeutic techniques investigated in this study. Ideally trainees would have repeated interval training sessions in therapeutic endoscopy and recurrent evaluations with feedback to enhance learning and skills development. However, practical costs and limitations of trainees’ study budgets prevent open access to simulator training. Lack of funding was the primary reason for the inability of interested trainees to attend this course and participate in the study. The conclusions drawn from this study do provide some evidence of the efficacy of these training methodologies when using realistic simulation of therapeutic procedures. This evidence should be used to continue improvements in both the simulator platforms and the training programs and support more widespread provision of affordable training. Additional stations for control of variceal bleeding and postpolypectomy bleeding are
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planned for future courses and will require similar evaluation. Advanced endoscopy courses including training in endoscopic stent insertion, double-balloon enteroscopy, and large EMR will be increasingly in demand for training before widespread adoption of hybrid endoscopic/surgical procedures such as endoscopic submucosal dissection and natural orifice transluminal endoscopic surgery. Continued evaluation of the training outcomes, especially with correlation with clinical endoscopic practice, will be vital to ensure the competency of practitioners and the safety of patients.
technical skill of gastroenterology fellows: a randomized controlled comparison with clinical endoscopy training alone. Gastrointest Endosc 2005;61:204-15. Maiss J, Millermann L, Heinemann K, et al. The compactEASIE is a feasible training model for endoscopic novices: a prospective randomised trial. Dig Liver Dis 2007;39:70-80. Matthes K. Simulator training in endoscopic hemostasis. Gastrointest Endosc Clin N Am 2006;16:511-27, viii. General Recommendations on Training in Gastrointestinal Endoscopy. The Joint Advisory Group on GI Endoscopy, 2008. Available at: http://www.thejag.org.uk/Whoareyou/Individualsintraining/tabid/57/Default.aspx. Accessed September 23, 2008 Martin JA, Regehr G, Reznick R, et al. Objective structured assessment of technical skill (OSATS) for surgical residents. Br J Surg 1997;84:273-8. Endoscopy National Workforce Competence. Skills for Health, 2008. Available at: http://tools.skillsforhealth.org.uk/suite/show/id/36. Accessed September 23, 2008. Emken JL, McDougall EM, Clayman RV. Training and assessment of laparoscopic skills. JSLS 2004;8:195-9. Fried GM. Lessons from the surgical experience with simulators: incorporation into training and utilization in determining competency. Gastrointest Endosc Clin N Am 2006;16:425-34. Thomas-Gibson S, Bassett P, Suzuki N, et al. Intensive training over 5 days improves colonoscopy skills long-term. Endoscopy 2007;39: 818-24. Adamsen S. Simulators and gastrointestinal endoscopy training. Endoscopy 2000;32:895-7. Gerson LB. Evidence-based assessment of endoscopic simulators for training. Gastrointest Endosc Clin N Am 2006;16:489-509, vii-viii. Cohen J, Cohen SA, Vora KC, et al. Multicenter, randomized, controlled trial of virtual-reality simulator training in acquisition of competency in colonoscopy. Gastrointest Endosc 2006;64:361-8. Sedlack RE, Kolars JC. Computer simulator training enhances the competency of gastroenterology fellows at colonoscopy: results of a pilot study. Am J Gastroenterol 2004;99:33-7. Kiesslich R, Moenk S, Reinhardt K, et al. Combined simulation training: a new concept and workshop is useful for crisis management in gastrointestinal endoscopy. Z Gastroenterol 2005;43:1031-9. Neumann M, Mayer G, Ell C, et al. The Erlangen Endo-Trainer: life-like simulation for diagnostic and interventional endoscopic retrograde cholangiography. Endoscopy 2000;32:906-10. Sedlack R, Petersen B, Binmoeller K, Kolars J. A direct comparison of ERCP teaching models. Gastrointest Endosc 2003;57:886-90. Hochberger J, Euler K, Naegel A, Hahn EG, Maiss J. The compact Erlangen Active Simulator for Interventional Endoscopy: a prospective comparison in structured team-training courses on ‘‘endoscopic hemostasis’’ for doctors and nurses to the ‘‘Endo-Trainer’’ model. Scand J Gastroenterol 2004;39:895-902. Goff B, Mandel L, Lentz G, et al. Assessment of resident surgical skills: is testing feasible? Am J Obstet Gynecol 2005;192:1331-40. Ault G, Reznick R, MacRae H, et al. Exporting a technical skills evaluation technology to other sites. Am J Surg 2001;182:254-6. Bann S, Khan M, Datta V, Darzi A. Surgical skill is predicted by the ability to detect errors. Am J Surg 2005;189:412-5. Broe D, Ridgway PF, Johnson S, et al. Construct validation of a novel hybrid surgical simulator. Surg Endosc 2006;20:900-4. Datta V, Bann S, Mandalia M, et al. The surgical efficiency score: a feasible, reliable, and valid method of skills assessment. Am J Surg 2006;192:372-8. Datta V, Chang A, Mackay S, et al. The relationship between motion analysis and surgical technical assessments. Am J Surg 2002;184: 70-3. Faulkner H, Regehr G, Martin J, et al. Validation of an objective structured assessment of technical skill for surgical residents. Acad Med 1996;71:1363-5. Goff BA, VanBlaricom A, Mandel L, et al. Comparison of objective, structured assessment of technical skills with a virtual reality hystero-
14.
15. 16.
17. 18.
ACKNOWLEDGMENTS 19.
We thank the following companies for their support in running the course and supplying equipment: Olympus Keymed, Southend-on-Sea, UK; Cook Endoscopy, Winston-Salem, NC, USA; Boston Scientific, Natick, Mass, USA; Fresenius Kabi Ltd, Runcorn, UK; ERBE Medical UK Ltd, Leeds, UK. We also thank all the endoscopy nurses and faculty for their time and expertise and all the course delegates for participation in the study.
20.
21.
22. 23. 24.
REFERENCES 1. Dafnis G, Ekbom A, Pahlman L, et al. Complications of diagnostic and therapeutic colonoscopy within a defined population in Sweden. Gastrointest Endosc 2001;54:302-9. 2. Guidelines on complications of gastrointestinal endoscopy. British Society of Gastroenterology, 2006. Available at: http://www.bsg.org.uk. Accessed July 24, 2008. 3. Hernandez LV, Jacobson JW, Harris MS. Comparison among the perforation rates of Maloney, balloon, and savary dilatation of esophageal strictures. Gastrointest Endosc 2000;51:460-2. 4. Anderson PE, Cook A, Amery AH. A review of the practice of fibreoptic endoscopic dilatation of oesophageal stricture. Ann R Coll Surg Engl 1989;71:124-7. 5. Riley SA, Attwood SE. Guidelines on the use of oesophageal dilatation in clinical practice. Gut 2004;53(Suppl 1):i1-6. 6. Jenkins JT, Glass G, Ballantyne S, Fullarton GM. Effect of MRCP introduction on ERCP practice: are there implications for service and training? Gut 2006;55:1365-6. 7. Atkinson RJ, Donnelly MT. Oesophageal stenting: trends in training in the UK. Endoscopy 2006;38(Suppl II):A162. 8. Baillie J. ERCP training: for the few, not for all. Gut 1999;45:9-10. 9. American Society for Gastrointestinal Endoscopy. Appropriate use of gastrointestinal endoscopy. Gastrointest Endosc 2000;52:831-7. 10. Axon AT, Aabakken L, Malfertheiner P, et al. Recommendations of the ESGE workshop on Ethics in Teaching and Learning Endoscopy. First European Symposium on Ethics in Gastroenterology and Digestive Endoscopy, Kos, Greece, June 2003. Endoscopy 2003;35:761-4. 11. Maiss J, Prat F, Wiesnet J, et al. The complementary Erlangen active simulator for interventional endoscopy training is superior to solely clinical education in endoscopic hemostasisdthe French training project: a prospective trial. Eur J Gastroenterol Hepatol 2006;18:1217-25. 12. Maiss J, Wiesnet J, Proeschel A, et al. Objective benefit of a 1-day training course in endoscopic hemostasis using the ‘‘compactEASIE’’ endoscopy simulator. Endoscopy 2005;37:552-8. 13. Hochberger J, Matthes K, Maiss J, et al. Training with the compactEASIE biologic endoscopy simulator significantly improves hemostatic
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scopy trainer and standard latex hysteroscopy model. J Reprod Med 2007;52:407-12. Hernandez JD, Bann SD, Munz Y, et al. Qualitative and quantitative analysis of the learning curve of a simulated surgical task on the da Vinci system. Surg Endosc 2004;18:372-8. Immenroth M, Burger T, Brenner J, et al. Mental training in surgical education: a randomized controlled trial. Ann Surg 2007;245:385-91. Kohls-Gatzoulis JA, Regehr G, Hutchison C. Teaching cognitive skills improves learning in surgical skills courses: a blinded, prospective, randomized study. Can J Surg 2004;47:277-83. Lentz GM, Mandel LS, Goff BA. A six-year study of surgical teaching and skills evaluation for obstetric/gynecologic residents in porcine and inanimate surgical models. Am J Obstet Gynecol 2005;193:2056-61. Nielsen PE, Foglia LM, Mandel LS, et al. Objective structured assessment of technical skills for episiotomy repair. Am J Obstet Gynecol 2003;189:1257-60. Reznick R, Regehr G, MacRae H, et al. Testing technical skill via an innovative ‘‘bench station’’ examination. Am J Surg 1997;173:226-30.
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Simulator training improves practical skills in therapeutic GI endoscopy
44. Haycock A, Suzuki N, Thomas-Gibson S. Development of a novel video scoring system for basic polypectomy: an initial validation study. [abstract]. Gastrointest Endosc 2007;65:AB329.
Received November 12, 2008. Accepted January 3, 2009. Current affiliations: Wolfson Unit for Endoscopy (A.V.H., P.Y., B.P.S., S.T.-G.), St. Mark’s Hospital, Imperial College London, London, UK, Department of Biosurgery and Surgical Technology (P.T.), Imperial College London, London, UK, Statsconsultancy Ltd (P.B.), Ruislip, Middlesex, UK. Reprint requests: Adam V. Haycock, MRCP, Wolfson Unit for Endoscopy, St. Mark’s Hospital, Watford Road, Harrow, Middlesex, HA1 3UJ UK. If you would like to chat with an author of this article, you may contact him at [email protected].
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APPENDIX 1
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Simulator training improves practical skills in therapeutic GI endoscopy: results from a randomized, blinded, controlled study Adam V. Haycock, MRCP, Philippa Youd, MRCP, Paul Bassett, Brian P. Saunders, MD, MRCP, Paris Tekkis, MD, FRCS, Siwan Thomas-Gibson, MD, MRCP London, United Kingdom
Background: Therapeutic endoscopic procedures are technically challenging and have higher complication rates than diagnostic procedures. Less-experienced practitioners are significantly more likely to have a complication, yet there is very limited evidence of the efficacy of training in such procedures. Objective: To evaluate the effect of knowledge-based teaching and hands-on, simulation-based skills training in 4 therapeutic endoscopic procedures: control of nonvariceal upper GI bleeding, polypectomy, stricture dilation, and percutaneous endoscopic gastrostomy (PEG) tube insertion. Design: Single-blind, randomized, controlled trial. Setting: Nationally accredited therapeutic endoscopy course. Participants and Intervention: Participants were randomized into groups to assess the effect of knowledgebased teaching and into subjects or controls to assess skills-based training. All delegates had an initial knowledge and skills assessment by blinded experts. Subjects received one-half day of hands-on skills training, whereas the controls did not. All delegates were retested on their procedural skills. Main Outcome Measurements: Knowledge was assessed by using a multiple-choice questionnaire. Practical skills were assessed using station-specific checklists and a global score. Results: Twenty-eight participants were randomized. There was no significant effect of knowledge-based teaching on the participants’ practical skills or initial multiple-choice questionnaire score, although there was a trend toward improvement. There was a significant improvement in the subjects compared with the controls in the performance of polypectomy, control of upper GI bleeding, and esophageal dilation. There were no significant differences for PEG tube insertion. Limitations: The 2-person nature of PEG tube insertion may have resulted in performance improvement despite a lack of training. Conclusion: Hands-on skills training significantly improved performance in 3 therapeutic modalities. Knowledge-based teaching alone did not have a measurable effect. These results strongly support the benefit of intensive hands-on, simulation-based courses for endoscopic skills training. (Gastrointest Endosc 2009;70:835-45.)
Copyright ª 2009 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 doi:10.1016/j.gie.2009.01.001
significantly more likely to encounter a complication than more experienced endoscopists.3-5 Trainee endoscopists require supervised hands-on experience to develop competence in safe procedure performance, but training in therapeutic endoscopy can be difficult to obtain.6-8 The American Society for Gastrointestinal Endoscopy state that short courses ‘‘should not be considered a substitute for training acquired during a formal residency/fellowship in an accredited training program’’9; however, the ability to practice therapeutic techniques on endoscopic simulators without associated risks to the patient early on in training would be advantageous.
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Therapeutic endoscopic procedures are technically challenging and have higher complication rates than diagnostic procedures.1,2 Less-experienced practitioners are Abbreviations: GS, global score; MCQ, multiple-choice questionnaire; PEG, percutaneous endoscopic gastrostomy; UGIB, upper GI bleeding; UK, United Kingdom. DISCLOSURE: All authors disclosed no financial relationships relevant to this publication.
Simulator training improves practical skills in therapeutic GI endoscopy
The European Society of Gastrointestinal Endoscopy has recommended that simulators, where available, should be used for training in GI endoscopy,10 and there is evidence that practice using endoscopy simulators can improve technical skills in endoscopic hemostasis.11-15 There is, however, no published literature regarding training in other therapeutic skills such as polypectomy, stricture dilation, and percutaneous endoscopic gastrostomy (PEG) tube insertion. Completion of a basic therapeutic endoscopy course is now recommended for all trainees wishing to become accredited in endoscopy in the United Kingdom (UK).16 The aim of this study was to evaluate the effect of knowledge-based teaching and hands-on skills training in 4 therapeutic endoscopic techniques: control of nonvariceal upper GI bleeding (UGIB), polypectomy, stricture dilation, and PEG tube insertion. The study used a singleblind, randomized, controlled trial to assess knowledge acquisition and change in practical skill.
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Capsule Summary What is already known on this topic d
Therapeutic endoscopy is technically challenging and has higher complication rates. Training on simulators improves technical skills in controlling of nonvariceal hemorrhage.
What this study adds to our knowledge d
In a single-blind trial of 26 randomized endoscopists, structured simulation-based training objectively improved technical skills in polypectomy, control of nonvariceal hemorrhage, and esophageal stricture dilation, whereas knowledge-based lectures alone did not.
A questionnaire was completed by all the participants to provide data on demographics, previous endoscopic experience, previous therapeutic procedures, selfreported measures of competence and confidence in ther-
apeutic endoscopy, and expectations regarding the training outcomes of the course. All participants were given four 40-minute lectures designed to present the knowledge base underlying safe therapeutic endoscopy. This forms a vital part of training and may have an impact on the skills performance on the simulators. To test for the effect of this knowledgebased teaching, participants were randomized to receive either the lectures first and then assessments of knowledge and practical skills (group 1) or the assessments first and then the lectures (group 2). Randomization was done by using a computer-generated block allocation protocol with 8 per block. The participants’ knowledge was assessed by using a multiple-choice questionnaire (MCQ) containing truefalse questions on all 4 modalities of therapeutic endoscopy. Participants’ procedural skills were assessed on each of the 4 therapeutic simulations. Nonvariceal hemostasis, snare polypectomy, and PEG tube insertion were performed on ex vivo models (Erlangen Endo Trainer; ECE-Training GmbH, Erlangen, Germany); esophageal stricture dilation was performed on a modified mechanical upper GI phantom (Adam; Rouilly Ltd, Kent, UK). The participants were given 10 minutes to complete each task to the best of their ability with an endoscopy assistant who would follow instructions competently, but would not offer instruction or be otherwise proactive. An expert observer and the endoscopy assistant assessed each participant. Both were blinded to the group allocation of participants. Specific skills tested were the use of injection, endoclips, and a bipolar diathermy probe for nonvariceal hemostasis; the technique for snare polypectomy and hot biopsy; manipulation of the endoscope for PEG tube insertion; and the technique for balloon dilation of an esophageal stricture. The subjects then received four 30-minute standardized practical hands-on skills training sessions on each therapeutic simulator taught by experienced endoscopists
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PATIENTS AND METHODS This was a prospective educational evaluation study performed at a single institution (academic endoscopy unit and national training center). The study was approved by our institutional review board and the Harrow ethics committee (07/H0719/52). Participants were drawn from a cohort of endoscopists who had already expressed an interest in attending the course, as well as from applications received in response to advertisements on 3 training-related websites and an e-mail to all gastroenterology trainees in the UK. Participants were eligible for inclusion if they had not previously attended a therapeutic endoscopy course, were currently exposed to at least 3 of the 4 therapeutic procedures, and would expect to continue being exposed to these therapeutic techniques after the course. Participants were excluded if they were already rated as being able to independently perform more than 2 of the 4 therapeutic procedures safely. The participants were recruited in 2 blocks of 16, with the study being run during 2 blocks of 3 days in September 2007 and April 2008. They were enrolled by the lead investigator and then randomized into subjects and controls by using a computer-generated block randomization protocol with 8 per block. Participants were informed of their allocation and the dates of the study intervention by the lead investigator; thus, neither was blinded to the group allocation.
Interventions
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Statistical analysis
Figure 1. Summary of the study design.
and senior endoscopy assistants in a one-to-one ratio. The control group was not given any skills training. Both the subjects and controls then had a reassessment of their practical skills on each simulator in a fashion identical to that of the initial assessment. After completion of the study, the control group received training identical to that received by the subject group (see Figure 1 for summary of the study design).
Main Outcome Measurements The knowledge-based outcome measure was the score obtained on the MCQ (maximum score, 97). The skillsbased outcome measures were station-specific checklists and a modified global rating scale17 termed a global score (GS) (Appendix 1), which assessed competence against previously defined levels taken from the UK national endoscopy competence framework.18 The expert observer completed both the checklist and GS, and the endoscopy assistant completed only the GS. Each checklist contained nodal stops, which were considered to be essential for the safe completion of the procedure. Failure to perform a nodal stop satisfactorily incurred a penalty of 3 points. The final checklist score was calculated as the sum of the completed checklist steps and penalty points. The total score was calculated as the sum of the final checklist score, the instructor GS, and the assistant GS. The primary endpoints were the difference in the MCQ score between the groups and the change in the skills assessment score from initial assessment to reassessment. Secondary endpoints were changes in the individual checklist scores; the GS and a subset of the GS, which was the experts’ rating of competence on a 5-point categorical scale. The data from the questionnaire were correlated with feedback forms completed after the end of the course. www.giejournal.org
The primary aim of the study was to examine the change in score between the initial skills assessment and the reassessment. When using the GS as the primary measure, a difference of 3 units in a score was considered of clinical importance, and it was estimated that the withinsubject standard deviation would be 4 units. With 5% significance and 80% power, 14 participants were required for the subject group, with an equivalent number for the control group, to detect a similar size difference over time. To allow for some dropout of participants and errors in data collection, recruitment aimed at enrolling a total of 32 participants in the study in 2 blocks of 16 participants. Statistical analysis was performed on an intent-to-treat basis. For the outcomes that were measured on a categorical scale, Fisher’s exact test was used to compare the results between the groups. For continuous measurements that were found to be non-normally distributed, the Mann-Whitney U test was used to compare variables between groups. For continuous measurements that were normally distributed, unpaired t tests were used to compare variables between groups, and paired t tests were used to compare changes within groups over time.
RESULTS Study participants Eighty-nine candidates expressed an interest in attending the course and were considered for inclusion in the study. Four did not meet eligibility criteria, and 57 were excluded because of an inability to get study leave or funding. Twenty-eight participants who met the eligibility criteria were randomized, with 26 completing the study. One subject did not receive the training because of illness, and one control had to leave for personal reasons before the final assessments (see Figure 2 for flow diagram of participants through each stage of the study). There was a spread of experience across the first 4 training years (4 first year, 6 second year, 4 third year, 4 fourth year) and 7 endoscopists currently not in training posts. All had current endoscopy exposure as described in the inclusion criteria. The subjects and controls were well matched with no significant differences in the demographics (Table 1) or previous endoscopy experience (Table 2). They were also well matched in their initial skills assessment scores, with only the UGIB checklist score showing that the subjects performed significantly better than controls (Table 3). This means that the subjects had a lower chance of improvement on this measure when comparing initial and final scores, which will bias against the subjects.
Expectations of trainees The expectations of trainees for the course were high, with an overall precourse expectation of 8.2 out of 10 on Volume 70, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY 837
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Figure 2. Flow diagram of participants through each stage of the study.
TABLE 1. Demographics of participants Variable Sex
Handedness
Grade
Specialty
Group
No. (%) controls
No. (%) subjects
P value
11 (85)
11 (73)
.66
Female
2 (15)
4 (27)
Left
0 (0)
1 (7)
Right
13 (100)
14 (93)
Specialist registrar
10 (77)
11 (73)
Consultant/other
3 (23)
4 (27)
Gastroenterology
11 (85)
11 (73)
2 (15)
4 (27)
Yes
11 (85)
11 (67)
No
2 (15)
4 (27)
Male
Surgery UK trained
1.00
1.00
.66
.66
UK, United Kingdom.
a visual analog scale. Expectations of how useful the course would be, how appropriate the learning objectives were for them, and how well the course would meet those learning objectives were also high. They also expected the course to be highly enjoyable. Feedback after the course
showed that it met or exceeded all their expectations. Specific feedback for each element of the course was also exceptionally good, with an average score of 8.4 out of 10. The practical hands-on sessions were rated especially highly, with an average score of 8.9 out of 10.
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TABLE 2. Age and previous endoscopic experience of participants Controls, median (range) Subjects, median (range) P value Age (y)
32 (28-45)
33 (28-55)
.39
105 (5-400)
90 (18-500)
.78
Precourse endoscopy experience Colonoscopy Flexible sigmoidoscopy
70 (10-700)
80 (10-400)
.72
Polypectomy
20 (5-75)
20 (0-300)
.55
EGD
400 (75-4000)
Therapeutic EGD
.39
25 (0-50)
20 (2-100)
.93
2 (0-20)
1 (0-10)
.59
15 (0-50)
5 (0-30)
.20
Esophageal dilations PEG insertion
300 (100-1200)
PEG, Percutaneous endoscopic gastrostomy.
TABLE 3. Initial skills assessment scores for subjects and controls
Group Polypectomy
Dilation
UGIB
PEG
Variable
Controls, median (range)
Subjects, median (range)
P value
10 ( 3 to 18)
.98
Checklist score
8 (1-18)
No. nodal stops
1 (0-2)
0 (0-2)
.56
Instructor GS total
19 (6-27)
17 (7-27)
.28
Assistant GS total
18 (7-30)
16 (6-28)
.21
Overall total
47 (15-64)
42 (12-67)
.45
Checklist score
9 (4-14)
7 (0-14)
.44
No. nodal stops
0 (0-1)
1 (0-1)
.23
Instructor GS total
15 (9-27)
16 (6-23)
.87
Assistant GS total
17 (8-21)
16 (7-24)
.61
Overall total
43 (26-61)
38 (16-58)
.50
Checklist score
8 (1-13)
12 (4-16)
.04
No. nodal stops
0 (0-1)
0 (0-1)
.86
Instructor GS total
17 (6-23)
17 (11-24)
.71
Assistant GS total
16 (10-30)
18 (7-28)
.64
Overall total
40 (17-59)
47 (24-63)
.32
Checklist score
13 ( 2 to 18)
14 (4-18)
.89
0 (0-2)
0 (0-0)
.50
Instructor GS total
22 (7-29)
21 (6- 30)
.75
Assistant GS total
21 (7-30)
20 (6-30)
.46
Overall total
56 (14-76)
47 (17-76)
.60
No. nodal stops
GS, Global score; UGIB, upper GI bleeding; PEG, percutaneous endoscopic gastrostomy.
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TABLE 4. Initial skills assessment scores for those who had the lectures before assessment (group 1) and the group who had the lectures after the assessment (group 2) Group 1, median (range)
Group 2, median (range)
P value
Checklist score
13 (3-18)
10 (5-15)
.13
No. nodal stops
0.5 (0-2)
1 (0-2)
.52
Instructor GS total
19 (7-27)
17 (6-24)
.15
Assistant GS total
18 (8-30)
16 (6-28)
.40
Overall total
48 (12-67)
40 (15-59)
.08
Checklist score
12 (5-14)
11 (3-13)
.51
No. nodal stops
1 (0-1)
0.5 (0-1)
.25
Group Polypectomy
Dilation
UGIB
PEG
Variable
Instructor GS total
17 (6-27)
16 (9-23)
.91
Assistant GS total
17 (7-21)
16 (7-24)
1.00
Overall total
44 (21-61)
41 (16-58)
.76
Checklist score
12 (6-16)
9 (1-15)
.30
No. nodal stops
0 (0-1)
0 (0-1)
.15
Instructor GS total
18 (11-24)
17 (6-24)
.28
Assistant GS total
18 (7-25)
17 (10-30)
.58
Overall total
47 (24-63)
41 (17-61)
.57
Checklist score
15 (4-18)
13 (5-17)
.55
No. nodal stops
0 (0-2)
0 (0-1)
.96
Instructor GS total
24 (6-29)
20 (8-30)
.68
Assistant GS total
19 (6-28)
21 (7-30)
.30
Overall total
56 (14-75)
51 (19-76)
.75
GS, Global score; UGIB, upper GI bleeding; PEG, percutaneous endoscopic gastrostomy.
Effect of lectures
There was a significant difference in the final reassessment scores (Table 5) and the median change from baseline (Table 6) for nearly all assessment measures between subjects and controls. There were significant differences
between groups for the polypectomy measures, with only the number of nodal stops not showing a difference between groups. For each score, the subject group was more likely to have a greater increase than the control group. The results for the stricture dilation show statistically significant differences between subjects and controls for all measures, with the subject group improving their scores more than the control group, although the difference for assistant GS was only of borderline statistical significance. For control of UGIB, there was a significant difference in the checklist score, number of nodal stops, and overall score, but not in the GS. For the checklist score and overall total, the subject group was more likely to have a greater increase in scores than the control group, despite the fact that the subjects originally scored higher than the controls for the checklist score on this station. There was no difference in median values for the number of nodal stops between the two groups, but the range of values indicated that nodal stops were performed
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Although there was a trend toward higher scores in the skills assessment for the group that had the lectures before assessment (Group 1) than the group who had the lectures after the assessment (Group 2), there was no statistically significant effect of the lectures on the participants’ practical skills (Table 4). There was no significant difference found in the initial MCQ score. The average (standard deviation) scores for group 1 were 70.6 (7.1) and 65.5 (8.7) for group 2 (P Z .10), demonstrating no measurable effect of knowledge-based teaching when using a knowledge assessment.
Effect of hands-on skills training
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TABLE 5. Final skills reassessment scores for subjects and controls
Group Polypectomy
Dilation
Variable
Subjects, median (range)
Checklist score
17 (14-19)
No. nodal stops
0 (0-1)
12.5 (2-19)
.011
0 (0-2)
.258
25 (16-30)
16.5 (9-24)
.001
Assistant GS total
26 (14-29)
19.5 (11-27)
.044
Overall total
67 (44-76)
48.5 (24-67)
.002
Checklist score
14 (8-15) 0 (0-1)
9 (0-13)
!.001
0.5 (0-1)
.067
21 (10-27)
.017
Instructor GS total
24 (15-30)
Assistant GS total
20 (13-30)
16.5 (9-22)
.174
Overall total
60 (36-75)
48.5 (22-61)
.005
Checklist score
17 (13-22)
8 (3-11)
!.0001
No. nodal stops
0 (0-1)
0 (0-1)
.142
23 (15-29)
18 (10-27)
.112
20 (7-29)
.051
Instructor GS total Assistant GS total
PEG
P value
Instructor GS total
No. nodal stops
UGIB
Controls, median (range)
24.5 (18-30)
Overall total
64 (53-75)
46 (24-65)
.001
Checklist score
18 (14-19)
16.5 (12-19)
.044
No. nodal stops
0 (0-0)
Instructor GS total
1.0
27.5 (21-30)
26 (11-29)
.077
26 (17-30)
26 (10-29)
.960
71.5 (52-79)
69 (33-74)
.129
Assistant GS total Overall total
0 (0-0)
GS, Global score; UGIB, upper GI bleeding; PEG, percutaneous endoscopic gastrostomy.
correctly more often by the subject group than the control group. There was no evidence of a difference between the groups for any of the measures for the insertion of a PEG tube. The change in overall score for each skill is shown in Figure 3.
Optimal patient care and outcomes of all types of endoscopic therapeutic procedures are highly dependent on the skill of the operator. How a trainee should safely and reliably gain this skill has frequently been debated. Traditionally, practical skills are gained by practicing on patients while being supervised by an expert, often over a prolonged period of time. Acquisition and refinement of the necessary cognitive and psychomotor skills inevitably result in performance errors by trainees, which may in turn result in poorer outcomes for patients. It may also be difficult for trainees to gain experience in uncommon, emergency, or difficult procedures. Surgeons have long
recognized that structured training with the use of simulators is advantageous for these types of procedures to be learned in a safe, controlled manner with no risk to patients.19,20 With increasing development of endoscope technology, GI endoscopy is becoming more and more focused on the provision of therapy within the GI tract. With the advent of natural orifice transluminal endoscopic surgery, endoscopists are looking to expand their skills extraluminally as well. As with all practical skills, there is a learning curve for these procedures, and the training issues that have concerned surgeons now equally apply to endoscopists. There are many different types of therapeutic endoscopy courses available, ranging from courses offering simple observation of procedures and courses providing hands-on practice by using endoscopy simulators to those offering supervised practice on real patients. Although lecturebased or observational courses may offer tips and tricks to aid self-improvement and have the ability to demonstrate advanced techniques without exposing patients to added risk, there is no evidence of their ability to alter
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TABLE 6. Change in score from initial skills assessment to reassessment for subjects and controls
Group Polypectomy
Dilation
UGIB
PEG
Variable
Controls, median (range)
Subjects, median (range)
P value
Checklist score
2 ( 7 to 9)
6 ( 2 to 15)
.03
No. nodal stops
0 ( 2 to 1)
0 ( 2 to 1)
.85
Instructor GS total
-2 ( 11 to 11)
7 (1-15)
Assistant GS total
-1 ( 12 to 8)
8 ( 8 to 16)
Overall total
-1 (-18 to 31)
21 (4-52)
Checklist score
2 ( 6 to 4)
3 (1-9)
No. nodal stops
0 ( 1 to 1)
1 ( 1 to 0)
.02
Instructor GS total
3 ( 4 to 11)
8 (1-14)
.02
Assistant GS total
2 ( 7 to 9)
6 ( 4 to 12)
.06
Overall total
3 ( 15 to 26)
Checklist score
!.001 .006 .002 !.001
18 (5-32)
.003
1 ( 7 to 6)
7 (2-11)
!.001
No. nodal stops
0 (0-1)
0 ( 1 to 0)
.02
Instructor GS total
3 ( 4 to 11)
6 ( 5 to 11)
.28
Assistant GS total
3 ( 7 to 11)
5 ( 2 to 14)
.18
Overall total
3 ( 5 to 25)
15 (3-32)
.004
Checklist score
4 (-3 to 12)
3 (0-12)
.68
No. nodal stops
0 ( 2 to 0)
0 (0-0)
.12
Instructor GS total
4 ( 3 to 16)
7 ( 5 to 22)
.24
Assistant GS total
3 (-2 to 18)
8 ( 4 to 13)
.28
12 ( 4 to 52)
19 ( 9 to 39)
.30
Overall total
GS, Global score; UGIB, upper GI bleeding; PEG, percutaneous endoscopic gastrostomy.
the actual skills of attendees. Practice on real patients may offer more expert training than is available at their home hospital, and there is some evidence that shows the long-term benefit of intensive hands-on courses in diagnostic colonoscopy.21 However, courses offering this type of training for therapeutics still run into all the problems of standard training methodologies in terms of limited exposure to procedures for trainees and risk of complications for patients. Courses based on simulation can provide an effective skills-training platform without any of these risks and with the many advantages of simulation such as repetition of procedures, predictability, and the use of real accessories. Computer simulations have been shown to be effective in the early phase of diagnostic endoscopic training,22,23 particularly for colonoscopy.24,25 However, they do not yet realistically simulate the tissue elasticity during therapeutic procedures, and there is as yet no evidence of their efficacy in this area. There is much more evidence of the use of ex vivo biosimulation models such as were used
in this evaluation. Ex vivo models have been shown to be effective in emergency endoscopy and crisis management skills training,26 ERCP,27,28 and endoscopic hemostasis.11-13,29
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Figure 3. Graph of change in overall score between initial assessment and reassessments for each therapeutic modality. Results are the interquartile range (range).
Haycock et al
Simulator training improves practical skills in therapeutic GI endoscopy
It is not surprising that they are effective because they allow repeated practice on realistic platforms. However, running such courses is expensive, requiring specific animal models that can be costly to purchase and maintain. The use of ex vivo models requires specialist facilities, often incurring extra location costs. The courses are also costly in terms of manpower and staff time, which must be factored into the charge passed on to participants. Evaluation of outcomes should form part of the quality assurance for such courses. This study is the first evaluation of a training course specifically tailored for the basic therapeutic skills required by independent practitioners. This evaluation demonstrated the effectiveness of intensive hands-on simulator training for improving practical skills in 3 different endoscopic therapeutic modalities. This extends the evidence of this type of training from purely endoscopic hemostasis to polypectomy and dilation in the GI tract. It is noteworthy that the training effect was measurable after a relatively short period (30 minutes) of one-on-one instruction. This study also shows that knowledge-based teaching alone does not have a measurable effect on performance, emphasizing the importance of specific hands-on training to improve the practical skills required. No measurable effect of structured skills training for insertion of a PEG tube was demonstrated. This may be because of the 2-person nature of the procedure. Unlike the other 3 modalities, in which the endoscopist performs the majority of the technical procedures and the assistant is in a helping mode, PEG tube insertion requires 2 operators of more equal skill. The endoscopist’s role is limited to examining the stomach and then snaring the string before withdrawal, which does not require either advanced hand skills or judgment. The majority of the technical aspects of the procedure (localizing the site, insertion of the trocha, assembly of the PEG tube) are performed by the assistant, who must be both knowledgeable and adequately trained in all aspects of the procedure. Both the assistant and the endoscopist have equal input in a successful insertion. The outcomes for this study were based on the change in performance of the endoscopist between two assessments. Both subjects and controls improved in all the scoring systems used, with a large range of scores measured. It is possible that the controls improved their performance merely by observation of a competent assistant during the initial assessment procedure. It may also be that the assessment tools used were additionally measuring the competence of the assistant, which may negate any deficiencies or competencies of the endoscopist. It may also be that this procedure is simpler to learn than the other therapeutic skills, and didactic learning may be enough to enhance performance without the need for hands-on training. The study did not show any effect of knowledge-based teaching by using a knowledge assessment. This is likely at-
tributable to weaknesses of the MCQ used for the assessment, which may not have reflected the lecture material closely enough. The validity of the skills assessment tools could also be questioned. Checklist scores and the GS form part of the objective structured assessment of technical skill format, which has previously been shown to be reliable and valid for use in assessment of surgical training.17,30-43 A checklist approach has also been successfully used in the assessment of hemostasis during simulated endoscopy.13 The polypectomy checklist has been previously validated,44 and the other checklists were created based on this format by the authors, but have not been validated individually. The GS was adapted from the surgical platform by the authors for therapeutic endoscopy, but not specifically validated. Further work is currently being performed to benchmark and assess the criterion validity of these tools as assessments of competency. Finally, there may also have been a performance effect attributable to differing motivations between the groups at the final assessment, with the subjects wanting to demonstrate their skill acquisition and the controls performing less well because of the frustration of repetitive testing. However, the subjects had no additional motivation to improve their performance, whereas the controls were still motivated by the expectation of subsequent training. The results from the PEG station also show that the controls did improve where there was the possibility of experiential learning. Although the results of this study show that hands-on skills training improves performance of simulated procedures, it does not provide evidence that such training translates into improved outcomes in clinical endoscopic practice. Follow-up of trainees’ performance in each modality over time by using standardized assessment tools would be necessary to show such an effect. One study showed that trainees receiving simulator as well as clinical training for hemostasis have a higher success rate and a decrease in the frequency of complications in their clinical practice compared with those who are just clinically trained.13 However, there are as yet no data showing clinical efficacy for the other therapeutic techniques investigated in this study. Ideally trainees would have repeated interval training sessions in therapeutic endoscopy and recurrent evaluations with feedback to enhance learning and skills development. However, practical costs and limitations of trainees’ study budgets prevent open access to simulator training. Lack of funding was the primary reason for the inability of interested trainees to attend this course and participate in the study. The conclusions drawn from this study do provide some evidence of the efficacy of these training methodologies when using realistic simulation of therapeutic procedures. This evidence should be used to continue improvements in both the simulator platforms and the training programs and support more widespread provision of affordable training. Additional stations for control of variceal bleeding and postpolypectomy bleeding are
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planned for future courses and will require similar evaluation. Advanced endoscopy courses including training in endoscopic stent insertion, double-balloon enteroscopy, and large EMR will be increasingly in demand for training before widespread adoption of hybrid endoscopic/surgical procedures such as endoscopic submucosal dissection and natural orifice transluminal endoscopic surgery. Continued evaluation of the training outcomes, especially with correlation with clinical endoscopic practice, will be vital to ensure the competency of practitioners and the safety of patients.
technical skill of gastroenterology fellows: a randomized controlled comparison with clinical endoscopy training alone. Gastrointest Endosc 2005;61:204-15. Maiss J, Millermann L, Heinemann K, et al. The compactEASIE is a feasible training model for endoscopic novices: a prospective randomised trial. Dig Liver Dis 2007;39:70-80. Matthes K. Simulator training in endoscopic hemostasis. Gastrointest Endosc Clin N Am 2006;16:511-27, viii. General Recommendations on Training in Gastrointestinal Endoscopy. The Joint Advisory Group on GI Endoscopy, 2008. Available at: http://www.thejag.org.uk/Whoareyou/Individualsintraining/tabid/57/Default.aspx. Accessed September 23, 2008 Martin JA, Regehr G, Reznick R, et al. Objective structured assessment of technical skill (OSATS) for surgical residents. Br J Surg 1997;84:273-8. Endoscopy National Workforce Competence. Skills for Health, 2008. Available at: http://tools.skillsforhealth.org.uk/suite/show/id/36. Accessed September 23, 2008. Emken JL, McDougall EM, Clayman RV. Training and assessment of laparoscopic skills. JSLS 2004;8:195-9. Fried GM. Lessons from the surgical experience with simulators: incorporation into training and utilization in determining competency. Gastrointest Endosc Clin N Am 2006;16:425-34. Thomas-Gibson S, Bassett P, Suzuki N, et al. Intensive training over 5 days improves colonoscopy skills long-term. Endoscopy 2007;39: 818-24. Adamsen S. Simulators and gastrointestinal endoscopy training. Endoscopy 2000;32:895-7. Gerson LB. Evidence-based assessment of endoscopic simulators for training. Gastrointest Endosc Clin N Am 2006;16:489-509, vii-viii. Cohen J, Cohen SA, Vora KC, et al. Multicenter, randomized, controlled trial of virtual-reality simulator training in acquisition of competency in colonoscopy. Gastrointest Endosc 2006;64:361-8. Sedlack RE, Kolars JC. Computer simulator training enhances the competency of gastroenterology fellows at colonoscopy: results of a pilot study. Am J Gastroenterol 2004;99:33-7. Kiesslich R, Moenk S, Reinhardt K, et al. Combined simulation training: a new concept and workshop is useful for crisis management in gastrointestinal endoscopy. Z Gastroenterol 2005;43:1031-9. Neumann M, Mayer G, Ell C, et al. The Erlangen Endo-Trainer: life-like simulation for diagnostic and interventional endoscopic retrograde cholangiography. Endoscopy 2000;32:906-10. Sedlack R, Petersen B, Binmoeller K, Kolars J. A direct comparison of ERCP teaching models. Gastrointest Endosc 2003;57:886-90. Hochberger J, Euler K, Naegel A, Hahn EG, Maiss J. The compact Erlangen Active Simulator for Interventional Endoscopy: a prospective comparison in structured team-training courses on ‘‘endoscopic hemostasis’’ for doctors and nurses to the ‘‘Endo-Trainer’’ model. Scand J Gastroenterol 2004;39:895-902. Goff B, Mandel L, Lentz G, et al. Assessment of resident surgical skills: is testing feasible? Am J Obstet Gynecol 2005;192:1331-40. Ault G, Reznick R, MacRae H, et al. Exporting a technical skills evaluation technology to other sites. Am J Surg 2001;182:254-6. Bann S, Khan M, Datta V, Darzi A. Surgical skill is predicted by the ability to detect errors. Am J Surg 2005;189:412-5. Broe D, Ridgway PF, Johnson S, et al. Construct validation of a novel hybrid surgical simulator. Surg Endosc 2006;20:900-4. Datta V, Bann S, Mandalia M, et al. The surgical efficiency score: a feasible, reliable, and valid method of skills assessment. Am J Surg 2006;192:372-8. Datta V, Chang A, Mackay S, et al. The relationship between motion analysis and surgical technical assessments. Am J Surg 2002;184: 70-3. Faulkner H, Regehr G, Martin J, et al. Validation of an objective structured assessment of technical skill for surgical residents. Acad Med 1996;71:1363-5. Goff BA, VanBlaricom A, Mandel L, et al. Comparison of objective, structured assessment of technical skills with a virtual reality hystero-
14.
15. 16.
17. 18.
ACKNOWLEDGMENTS 19.
We thank the following companies for their support in running the course and supplying equipment: Olympus Keymed, Southend-on-Sea, UK; Cook Endoscopy, Winston-Salem, NC, USA; Boston Scientific, Natick, Mass, USA; Fresenius Kabi Ltd, Runcorn, UK; ERBE Medical UK Ltd, Leeds, UK. We also thank all the endoscopy nurses and faculty for their time and expertise and all the course delegates for participation in the study.
20.
21.
22. 23. 24.
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Simulator training improves practical skills in therapeutic GI endoscopy
44. Haycock A, Suzuki N, Thomas-Gibson S. Development of a novel video scoring system for basic polypectomy: an initial validation study. [abstract]. Gastrointest Endosc 2007;65:AB329.
Received November 12, 2008. Accepted January 3, 2009. Current affiliations: Wolfson Unit for Endoscopy (A.V.H., P.Y., B.P.S., S.T.-G.), St. Mark’s Hospital, Imperial College London, London, UK, Department of Biosurgery and Surgical Technology (P.T.), Imperial College London, London, UK, Statsconsultancy Ltd (P.B.), Ruislip, Middlesex, UK. Reprint requests: Adam V. Haycock, MRCP, Wolfson Unit for Endoscopy, St. Mark’s Hospital, Watford Road, Harrow, Middlesex, HA1 3UJ UK. If you would like to chat with an author of this article, you may contact him at [email protected].
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APPENDIX 1
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Volume 70, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY 845.e2