Focus of Study: Cognitive Surgical Skill AcquisitionNCT01866436
Educational Study of Multimedia in Surgical Skills Training in Colorectal Surgery
A study testing Multimedia group and Study Day Group in people with Focus of Study: Cognitive Surgical Skill Acquisition, run by University of Sheffield at 1 site in United Kingdom.
Trial summary
To practice independently surgeons require competency in surgical skills, encompassing a combination of technical and non-technical skills. Cognitive skills, aspects of non-technical skills, represent an integral component of surgical competency. Cognitive skills comprise factual knowledge and decision-making. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Focus of Study: Cognitive Surgical Skill Acquisition
- What is being tested?
- Multimedia group and Study Day Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Postgraduate specialist general surgical trainees at Speciality Training Year 3 (ST3) level/ Specialist Registrar (SpR) Year 1 or above
Who cannot join
- Postgraduate general surgical trainees below ST3 level/ SPR Year 1
- ALL non general surgical postgraduate trainees
- Medical students
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Surgical Oncology Unit, University of Sheffield
Sheffield, South Yorkshire, S10 2RX
About this study
Official title: The Role of Multimedia in Cognitive Surgical Skill Acquisition in Open and Laparoscopic Colorectal Surgery
To practice independently surgeons require competency in surgical skills, encompassing a combination of technical and non-technical skills. Cognitive skills, aspects of non-technical skills, represent an integral component of surgical competency. Cognitive skills comprise factual knowledge and decision-making.
Changing work patterns in the United Kingdom, as specified by the European Working Time Directive (EWTD), have had a profound impact on the delivery of surgical skills training. Surgical trainees are now increasingly removed from normal working hours in which the majority of traditional operative training and experience is gained, leading to a net reduction in trainees' operative exposure. This reduction in operative experience means that surgical competence can no longer be assured on the basis of experience alone.
Read more
Although there is no educational technology that can replace the craft apprenticeship required to train a competent surgeon, reduction in training hours has led to rapid development of educational tools to augment surgical skills training outside the operating room environment. These tools tend to concentrate on technical skills performance without emphasis on cognitive skills.
Trainees in today's era have grown up in a multimedia environment; multimedia is media that uses a combination of text, voiceover, animation and video. Multimedia is an underdeveloped educational resource that can supplement cognitive skills training in operative surgery.
The purpose of this study was to design and develop an online multimedia educational tool in a common colorectal surgery procedure ("Anterior Resection") and determine the effectiveness of this tool in teaching and assessment of cognitive skills.
Study hypothesis: Multimedia learning is equivalent to conventional teaching "Study Day" in improving scores in cognitive surgical skills.
Read the detailed description
This study involved two main objectives:
- Develop and design multimedia educational tools for open and laparoscopic anterior resection
- The multimedia tools were developed in collaboration with a professional multimedia company (Digimed). Initially 31 open and 35 laparoscopic (key-hole) procedures were filmed after informed, written consent was obtained from patients. Key procedural steps/ subtasks were identified and integrated onto navigational interactive interface platforms developed using Adobe® Flash® Professional CS5 10.1.
- Each subtask was composited into succinct video clips using Final Cut Pro®, supplemented with annotation, animation, text and voiceover. Content addressed cognitive aspects including factual and anatomical knowledge, decision-making points, instrumentation required, team positioning and use of assistance. The multimedia educational tools are available online at following the link http://www.colorectaltraining.co.uk. The colorectal training website has 1.24GB including 69 video clips in the open tool and 67 video clips in the laparoscopic tool.
- Evaluate the effectiveness of multimedia in teaching/assessment of cognitive surgical skills
- A randomised control study was conducted to evaluate the effectiveness of online multimedia in comparison to conventional "Study day" teaching in cognitive surgical skills acquisition. Enrolled participants were randomly allocated into either the intervention (Multimedia) or control (Study Day) Group. The methodology of the assessments was online timed (written) assessments to test cognitive surgical skills. All trainees were assessed before and after the study period.
- Following ethics approval, permission was obtained from surgical training programme directors (TPDs) to recruit trainees into the study. The study was conducted between 6th October 2011 and 23rd December 2011. Trainees invited to participate were contacted by email. A study flyer attachment and hyperlink (http://www.colorectaltraining.co.uk) were provided for trainees to access relevant study information on a 'Participation Information Sheet' and an online consent form. After submission of the consent form, trainees were directed to separate web pages on the secure web-based service containing a Trainee Proforma (to obtain demographic participant information) and Pre-Assessment Test.
- Participants in the multimedia group were provided with unrestricted access for 30 days and the study day was held at the end of this period for the "Study Day" group. Multimedia group participants were each emailed an individual login and password to access the multimedia tools on the colorectal training website: http://www.colorectaltraining.co.uk. The login details were requested each time the website was accessed.
- The study day involved a series of detailed interactive lectures covering all the steps of open and laparoscopic anterior resection surgery. The content delivered was identical to that in the multimedia tool. After a period of one week, all study participants were required to complete the online Post-Assessment test. Multimedia group participants emailed a separate hyperlink to complete an online Evaluation form. All completed forms were stored securely for analysis.
- Sample size
- Sample size was calculated on the basis of a pilot study of 50 surgical trainees taking part in an anterior resection study day in January 2009. Trainees were asked to complete a pre-study day written assessment, followed by a post-study day assessment immediately after the lectures had been completed. The mean (SD) pre- and post-assessments scores were 12.4 (4.56) and 26.8 (3.99) respectively.
- The sample size was calculated with the mean change under the assumption that the baseline (pre-assessment) score for both arms is the same. Mean change in score in the control is 14.4 (4.9) and an expected mean change in score of 24.4 (SD 4.9) in the intervention group is assumed. The sample size required to test the hypothesis at a type I error of 5% and power of 80% was calculated (per group) to be 10. So a total of 20 trainees need to be recruited. If the response rate is 20% and assuming a drop off rate of 20% ((20/20%)/ (1-20%)), a total of 125 trainees needed to be approached.
- Statistical analysis
- The baseline pre-assessment test ensured comparability of knowledge base and cognitive skills between study groups and helped to assess construct validity of the assessment tool. Basic descriptive statistics include the numbers and percentages for categorical data, mean and standard deviation for normally distributed continuous data; median and range for skewed data was also included. All data were analysed on an intention to treat basis.
- Differences in assessment scores between multimedia and control (study day) groups were compared using either the unpaired Students' t-test (for normally distributed data) or the Mann Whitney U test (for skewed data). To analyse post-scores versus pre-test scores within the same group, paired t-test (for normally distributed data) or the Mann Whitney U test (for skewed data) was used. Data was analysed using SPSS (statistical package for social sciences version 16.0, Chicago IL). Significance levels were set at P<0.05.
- Being tested
- Multimedia group, Study Day Group
- Keywords
- Cognitive skills, Multimedia, Education, Colorectal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimedia groupOther
Also called Anterior Resection Multimedia Educational Tools, http://www.colorectaltraining.co.uk
Participants are provided with unrestricted access to the online multimedia educational tools for self-directed study (during the study period)
Study Day GroupOther
Participants in the control arm of the study attend a conventional teaching "Study Day" involving a series of lectures on Open and Laparoscopic Anterior Resection
| Study group | Role | What they receive |
|---|---|---|
| Multimedia group | Experimental | The multimedia group is the interventional arm of the study Receives: Other: Multimedia group |
| Study Day Group | Experimental | The study day group are the control arm of the study Receives: Other: Study Day Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in assessment scores following implementation of the teaching modality (Multimedia and Study day).
All participants were assessed using a timed 30 minute online tool (sent via a hyperlink) to test cognitive skills both before and after the teaching modality. The assessment tool comprised a random assortment of 30 multiple choice and short answer questions. A similar test had been previously validated. A large bank of two hundred questions was designed to comprehensively cover cognitive skills relevant to all the procedural steps in open and laparoscopic 'anterior resection' surgery. The question content was germane to the information delivered in the multimedia tools and study day. Completed forms were stored securely on Smart Survey software. The purpose of the on-line pre-assessment test score was to establish the baseline level knowledge of all participants, prior to randomisation.
Measured: Participants will be followed for the duration of the educational study, a period of 11 weeks
Secondary outcomes (1)
The association between change in scores and level of training and acceptability of multimedia as an educational resource.
Measured: Participants will be followed for the duration of the educational study, a period of 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Focus of Study: Cognitive Surgical Skill AcquisitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon Endo-Surgery, HCA International Limited, Digimed
- Responsible party
- Principal investigator, Umar Shariff, University of Sheffield
- Investigators
- Umar Shariff, MBChB, MRCS, Principal investigator, University of SheffieldSaba Balasubramanian, PhD, FRCS, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866436
- Sponsor's protocol ID
- SMBRER186
- Status last verified
- May 2013
- First submitted
- 14 May 2013
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Fitzgerald JE, Caesar BC. The European Working Time Directive: a practical review for surgical trainees. Int J Surg. 2012;10(8):399-403. doi: 10.1016/j.ijsu.2012.08.007. Epub 2012 Aug 24.
PubMed 22925631Moonesinghe SR, Lowery J, Shahi N, Millen A, Beard JD. Impact of reduction in working hours for doctors in training on postgraduate medical education and patients' outcomes: systematic review. BMJ. 2011 Mar 22;342:d1580. doi: 10.1136/bmj.d1580.
PubMed 21427046Beard JD. Assessment of surgical competence. Br J Surg. 2007 Nov;94(11):1315-6. doi: 10.1002/bjs.6048. No abstract available.
PubMed 17939136Reznick RK. Surgical simulation: a vital part of our future. Ann Surg. 2005 Nov;242(5):640-1. doi: 10.1097/01.sla.0000186270.53049.74. No abstract available.
PubMed 16244535Kneebone RL. Skills training using multimedia and models. Hosp Med. 2001 Jul;62(7):428-30. doi: 10.12968/hosp.2001.62.7.1615.
PubMed 11480133Shariff U, Kullar N, Haray PN, Dorudi S, Balasubramanian SP. Multimedia educational tools for cognitive surgical skill acquisition in open and laparoscopic colorectal surgery: a randomized controlled trial. Colorectal Dis. 2015 May;17(5):441-50. doi: 10.1111/codi.12863.
PubMed 25495835
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Multimedia in Cognitive Surgical Skill Acquisition in Open and Laparoscopic Colorectal Surgery
- ClinicalTrials.gov ID
- NCT01866436
- Acronym / sponsor ID
- SMBRER186
- Keywords
- Cognitive skills, Multimedia, Education, Colorectal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- Ethicon Endo-Surgery, HCA International Limited, Digimed
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To practice independently surgeons require competency in surgical skills, encompassing a combination of technical and non-technical skills. Cognitive skills, aspects of non-technical skills, represent an integral component of surgical competency. Cognitive skills comprise factual knowledge and decision-making.
Changing work patterns in the United Kingdom, as specified by the European Working Time Directive (EWTD), have had a profound impact on the delivery of surgical skills training. Surgical trainees are now increasingly removed from normal working hours in which the majority of traditional operative training and experience is gained, leading to a net reduction in trainees' operative exposure. This reduction in operative experience means that surgical competence can no longer be assured on the basis of experience alone.
Although there is no educational technology that can replace the craft apprenticeship required to train a competent surgeon, reduction in training hours has led to rapid development of educational tools to augment surgical skills training outside the operating room environment. These tools tend to concentrate on technical skills performance without emphasis on cognitive skills.
Trainees in today's era have grown up in a multimedia environment; multimedia is media that uses a combination of text, voiceover, animation and video. Multimedia is an underdeveloped educational resource that can supplement cognitive skills training in operative surgery.
The purpose of this study was to design and develop an online multimedia educational tool in a common colorectal surgery procedure ("Anterior Resection") and determine the effectiveness of this tool in teaching and assessment of cognitive skills.
Study hypothesis: Multimedia learning is equivalent to conventional teaching "Study Day" in improving scores in cognitive surgical skills.
Detailed description
This study involved two main objectives:
- Develop and design multimedia educational tools for open and laparoscopic anterior resection
- The multimedia tools were developed in collaboration with a professional multimedia company (Digimed). Initially 31 open and 35 laparoscopic (key-hole) procedures were filmed after informed, written consent was obtained from patients. Key procedural steps/ subtasks were identified and integrated onto navigational interactive interface platforms developed using Adobe® Flash® Professional CS5 10.1.
- Each subtask was composited into succinct video clips using Final Cut Pro®, supplemented with annotation, animation, text and voiceover. Content addressed cognitive aspects including factual and anatomical knowledge, decision-making points, instrumentation required, team positioning and use of assistance. The multimedia educational tools are available online at following the link http://www.colorectaltraining.co.uk. The colorectal training website has 1.24GB including 69 video clips in the open tool and 67 video clips in the laparoscopic tool.
- Evaluate the effectiveness of multimedia in teaching/assessment of cognitive surgical skills
- A randomised control study was conducted to evaluate the effectiveness of online multimedia in comparison to conventional "Study day" teaching in cognitive surgical skills acquisition. Enrolled participants were randomly allocated into either the intervention (Multimedia) or control (Study Day) Group. The methodology of the assessments was online timed (written) assessments to test cognitive surgical skills. All trainees were assessed before and after the study period.
- Following ethics approval, permission was obtained from surgical training programme directors (TPDs) to recruit trainees into the study. The study was conducted between 6th October 2011 and 23rd December 2011. Trainees invited to participate were contacted by email. A study flyer attachment and hyperlink (http://www.colorectaltraining.co.uk) were provided for trainees to access relevant study information on a 'Participation Information Sheet' and an online consent form. After submission of the consent form, trainees were directed to separate web pages on the secure web-based service containing a Trainee Proforma (to obtain demographic participant information) and Pre-Assessment Test.
- Participants in the multimedia group were provided with unrestricted access for 30 days and the study day was held at the end of this period for the "Study Day" group. Multimedia group participants were each emailed an individual login and password to access the multimedia tools on the colorectal training website: http://www.colorectaltraining.co.uk. The login details were requested each time the website was accessed.
- The study day involved a series of detailed interactive lectures covering all the steps of open and laparoscopic anterior resection surgery. The content delivered was identical to that in the multimedia tool. After a period of one week, all study participants were required to complete the online Post-Assessment test. Multimedia group participants emailed a separate hyperlink to complete an online Evaluation form. All completed forms were stored securely for analysis.
- Sample size
- Sample size was calculated on the basis of a pilot study of 50 surgical trainees taking part in an anterior resection study day in January 2009. Trainees were asked to complete a pre-study day written assessment, followed by a post-study day assessment immediately after the lectures had been completed. The mean (SD) pre- and post-assessments scores were 12.4 (4.56) and 26.8 (3.99) respectively.
- The sample size was calculated with the mean change under the assumption that the baseline (pre-assessment) score for both arms is the same. Mean change in score in the control is 14.4 (4.9) and an expected mean change in score of 24.4 (SD 4.9) in the intervention group is assumed. The sample size required to test the hypothesis at a type I error of 5% and power of 80% was calculated (per group) to be 10. So a total of 20 trainees need to be recruited. If the response rate is 20% and assuming a drop off rate of 20% ((20/20%)/ (1-20%)), a total of 125 trainees needed to be approached.
- Statistical analysis
- The baseline pre-assessment test ensured comparability of knowledge base and cognitive skills between study groups and helped to assess construct validity of the assessment tool. Basic descriptive statistics include the numbers and percentages for categorical data, mean and standard deviation for normally distributed continuous data; median and range for skewed data was also included. All data were analysed on an intention to treat basis.
- Differences in assessment scores between multimedia and control (study day) groups were compared using either the unpaired Students' t-test (for normally distributed data) or the Mann Whitney U test (for skewed data). To analyse post-scores versus pre-test scores within the same group, paired t-test (for normally distributed data) or the Mann Whitney U test (for skewed data) was used. Data was analysed using SPSS (statistical package for social sciences version 16.0, Chicago IL). Significance levels were set at P<0.05.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimedia group | Experimental | Other: Multimedia groupThe multimedia group is the interventional arm of the study |
| Study Day Group | Experimental | Other: Study Day GroupThe study day group are the control arm of the study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Postgraduate specialist general surgical trainees at Speciality Training Year 3 (ST3) level/ Specialist Registrar (SpR) Year 1 or above
Key exclusion criteria (3 listed)
- Postgraduate general surgical trainees below ST3 level/ SPR Year 1
- ALL non general surgical postgraduate trainees
- Medical students
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimedia groupAlso: Anterior Resection Multimedia Educational Tools, http://www.colorectaltraining.co.ukParticipants are provided with unrestricted access to the online multimedia educational tools for self-directed study (during the study period) | Other | Multimedia group |
| Study Day GroupParticipants in the control arm of the study attend a conventional teaching "Study Day" involving a series of lectures on Open and Laparoscopic Anterior Resection | Other | Study Day Group |
Primary outcome
Improvement in assessment scores following implementation of the teaching modality (Multimedia and Study day).
Time frame: Participants will be followed for the duration of the educational study, a period of 11 weeks
All participants were assessed using a timed 30 minute online tool (sent via a hyperlink) to test cognitive skills both before and after the teaching modality. The assessment tool comprised a random assortment of 30 multiple choice and short answer questions. A similar test had been previously validated. A large bank of two hundred questions was designed to comprehensively cover cognitive skills relevant to all the procedural steps in open and laparoscopic 'anterior resection' surgery. The question content was germane to the information delivered in the multimedia tools and study day. Completed forms were stored securely on Smart Survey software. The purpose of the on-line pre-assessment test score was to establish the baseline level knowledge of all participants, prior to randomisation.
1 secondary outcome
The association between change in scores and level of training and acceptability of multimedia as an educational resource.
Time frame: Participants will be followed for the duration of the educational study, a period of 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
- Background: PubMed 22925631Fitzgerald JE, Caesar BC. The European Working Time Directive: a practical review for surgical trainees. Int J Surg. 2012;10(8):399-403. doi: 10.1016/j.ijsu.2012.08.007. Epub 2012 Aug 24.
- Background: PubMed 21427046Moonesinghe SR, Lowery J, Shahi N, Millen A, Beard JD. Impact of reduction in working hours for doctors in training on postgraduate medical education and patients' outcomes: systematic review. BMJ. 2011 Mar 22;342:d1580. doi: 10.1136/bmj.d1580.
- Background: PubMed 17939136Beard JD. Assessment of surgical competence. Br J Surg. 2007 Nov;94(11):1315-6. doi: 10.1002/bjs.6048. No abstract available.
- Background: PubMed 16244535Reznick RK. Surgical simulation: a vital part of our future. Ann Surg. 2005 Nov;242(5):640-1. doi: 10.1097/01.sla.0000186270.53049.74. No abstract available.
- Background: PubMed 11480133Kneebone RL. Skills training using multimedia and models. Hosp Med. 2001 Jul;62(7):428-30. doi: 10.12968/hosp.2001.62.7.1615.
- Derived from this study: PubMed 25495835Shariff U, Kullar N, Haray PN, Dorudi S, Balasubramanian SP. Multimedia educational tools for cognitive surgical skill acquisition in open and laparoscopic colorectal surgery: a randomized controlled trial. Colorectal Dis. 2015 May;17(5):441-50. doi: 10.1111/codi.12863.
- Online link for the Open and Laparoscopic Anterior Resection Multimedia Educational Tools. Access the tools by using the following login details: Username: colorectal Password: colorectalLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umar Shariff, MBChB, MRCS principal investigator
University of Sheffield
Saba Balasubramanian, PhD, FRCS principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimedia group and Study Day Group in people with Focus of Study: Cognitive Surgical Skill Acquisition, run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in assessment scores following implementation of the teaching modality (Multimedia and Study day). (time frame: Participants will be followed for the duration of the educational study, a period of 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01866436, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2013.