Instructional Video and Medical Student Surgical Knot-Tying Proficiency: Randomized Controlled Trial

Background Many senior medical students lack simple surgical and procedural skills such as knot tying. Objective The aim of this study was to determine whether viewing a Web-based expert knot-tying training video, in addition to the standard third-year medical student curriculum, will result in more proficient surgical knot tying. Methods At the start of their obstetrics and gynecology clerkship, 45 students were videotaped tying surgical knots for 2 minutes using a board model. Two blinded female pelvic medicine and reconstructive surgery physicians evaluated proficiency with a standard checklist (score range 0-16) and anchored scoring scale (range 0-20); higher numbers represent better skill. Students were then randomized to either (1) expert video (n=26) or (2) nonvideo (n=24) groups. The video group was provided unlimited access to an expert knot-tying instructional video. At the completion of the clerkship, students were again videotaped and evaluated. Results At initial evaluation, preclerkship cumulative scores (range 0-36) on the standard checklist and anchored scale were not significantly different between the nonvideo and video groups (mean 20.3, SD 7.1 vs mean 20.2, SD 9.2, P=.90, respectively). Postclerkship scores improved in both the nonvideo and video groups (mean 28.4, SD 5.4, P<.001 and mean 28.7, SD 6.5, P=.004, respectively). Increased knot board practice was significantly correlated with higher postclerkship scores on the knot-tying task, but only in the video group (r=.47, P<.05). Conclusions The addition of a Web-based expert instructional video to a standard curriculum, coupled with knot board practice, appears to have a positive impact on medical student knot-tying proficiency.

Many senior medical students lack simple surgical and procedural skills such as knot tying [1]. Initiatives including first and second year medical school electives have been proposed to provide early instruction in surgical skills and operating room etiquette [2][3][4]. The transition from a primarily didactic to a clinically based curriculum between the second and third year of medical school can also be anxiety provoking. In a study performed by Stewart et al [5], medical students entering their clinical years had low levels of confidence and high anxiety related to performing common procedural skills such as knot tying. Following a 4-hour preclinical training course, the students reported increased confidence and proficiency and lowered levels of anxiety. Focused surgical skills electives have also been implemented to help prepare senior medical students for entering residency [6][7][8].
There is no standardized method of teaching medical students knot-tying skills and several curricula have been proposed [9][10][11]. Gershuni et al [12] suggested a proficiency-based suturing and knot-tying program early in the fourth year of medical school and Naylor et al [13] demonstrated the benefits of a simulator-based curriculum with third-year medical students. Computer-based video instruction (CBVI) has also been used to teach medical students suturing and knot tying [14][15][16]. Xeroulis et al [17] demonstrated that medical students taught suturing and knot tying with CBVI showed greater retention of skills at 1 month than controls and students taught by instructors with concurrent or summary feedback. The authors concluded that CBVI could be an efficient and useful adjunct for basic skills training. Similarly, Yeung et al [18] performed a prospective randomized controlled trial comparing the use of text versus video as an education tool for laparoscopic intracorporeal knot tying with medical students. The authors found that the video group achieved superior conceptual understanding of the task compared to the text group. Additionally, if medical students cannot tie surgical knots, they are often marginalized in the operating room. DiMaggio et al [19] demonstrated the importance of simulation practice in a study evaluating medical students who participated in a 2-day surgical skills laboratory session before starting their surgery clerkship. Students who completed this session expressed that participation in the cadaver laboratory allowed them a greater opportunity to suture in the operating or emergency room during their clerkship. 2a-ii) Scientific background, rationale: What is known about the (type of) system This is not an issue in this manuscript Does your paper address CONSORT subitem 2b?
Overall, in our practice, we have noted that third-year medical students participating in their obstetrics and gynecology clerkship have a dearth of knot-tying experience. Using a prospective, randomized controlled study design, we sought to determine whether having access to an expert knot-tying training video would result in more proficient surgical knot tying.

3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio
Between November 2015 and March 2016, 55 third-year medical students were approached at the start of their obstetrics and gynecology clerkships for inclusion in this Institutional Review Board-exempt study. As part of the standard curriculum at Northwestern University's Feinberg School of Medicine in Chicago, IL, all medical students underwent a 1-hour knot-tying education session on the first day of their clerkship. This session involved both didactics and a hands-on knot-tying workshop led by an attending physician. Participating medical students were then randomized to either the standard curriculum ("no video" group) or to the "video" group. Students in the video group received unlimited access to a Web-based expert instructional video on surgical knot tying (courtesy of Dr John OL DeLancey). Students in both groups received access to a knot-tying board for home practice for the duration of their clerkship. At the conclusion of their clerkship, all students received access to the expert knot-tying video. On the second day of their clerkship, students in both groups were videotaped tying as many square, two-handed knots as they could on a knot-tying board in 2 minutes. Students in both groups also provided demographic (sex, age, race) and prior experience information (number of prior surgical rotations, comfort level with knot tying with range 0-10 and higher numbers indicating more comfort), family members in medicine, and if they were anticipating entering a surgical career. At the conclusion of their 4-week clerkship, students were again videotaped completing the knot-tying task and a satisfaction survey was administered (range 0-10 on nine measures, higher values indicating higher satisfaction with how knot tying was taught during the rotation). Students also self-reported the number of times they had viewed the expert video and practiced knot tying outside of the clinical setting using their knot board. Videos of students performing the knot-tying tasks were viewed by two blinded female pelvic medicine and reconstructive surgery physicians who evaluated medical student proficiency using a standard knot-tying checklist (score range 0-16) and an anchored scale (range 0-20). The standard knot-tying checklist responses were 1=yes and 2=no on eight knot-tying metrics, including the following: sutures start crossed, index finger lifts suture to form loop, fingers pinch together, push suture through and grasp/tighten, hook thumb under suture, form loop, fingers pinch together, and push suture through and grasp/tighten. The anchored scale was based on a modified objective structured assessment of technical skill scale, which assigned scores from 1 to 5 on four separate procedure domains: respect for tissue, time and motion, instrument handling, and flow of operation and forward planning [20]. Higher scores represented better skills on both metrics. At the completion of the 4-week rotation, all students were again videotaped and evaluated. Statistical analysis was carried out using SPSS version 20 (Chicago, IL, USA). Paired t tests, Student t tests, Fisher exact, and Pearson correlations were calculated. 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons Participants were not included in the trial if they did not complete the clerkship.

3b-i) Bug fixes, Downtimes, Content Changes N/A in our study 4a) CONSORT: Eligibility criteria for participants
Between November 2015 and March 2016, 55 third-year medical students were approached at the start of their obstetrics and gynecology clerkships for inclusion in this Institutional Review Board-exempt study. 4a-i) Computer / Internet literacy All medical students were able to access video without difficulty. 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: On the second day of their clerkship, students in both groups were videotaped tying as many square, two-handed knots as they could on a knot-tying board in 2 minutes. 4a-iii) Information giving during recruitment This study was IRB exempt per our institution 4b) CONSORT: Settings and locations where the data were collected Data was collected in an FPMRS office 4b-i) Report if outcomes were (self-)assessed through online questionnaires Hand written questionnaires were filled out by the participants 4b-ii) Report how institutional affiliations are displayed This was N/A in our study 5) CONSORT: Describe the interventions for each group with sufficient details to allow replication, including how and when they were actually administered 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners Not applicable in our study 5-ii) Describe the history/development process Not applicable in our study

5-iii) Revisions and updating
Not applicable in our study 5-iv) Quality assurance methods Not applicable in our study 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Not applicable in our study 5-vi) Digital preservation Not applicable in our study

5-vii) Access
Not applicable in our study

6a) CONSORT: Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed
Videos of students performing the knot-tying tasks were viewed by two blinded female pelvic medicine and reconstructive surgery physicians who evaluated medical student proficiency using a standard knot-tying checklist (score range 0-16) and an anchored scale (range 0-20). The standard knot-tying checklist responses were 1=yes and 2=no on eight knot-tying metrics, including the following: sutures start crossed, index finger lifts suture to form loop, fingers pinch together, push suture through and grasp/tighten, hook thumb under suture, form loop, fingers pinch together, and push suture through and grasp/tighten. The anchored scale was based on a modified objective structured assessment of technical skill scale, which assigned scores from 1 to 5 on four separate procedure domains: respect for tissue, time and motion, instrument handling, and flow of operation and forward planning [20]. Higher scores represented better skills on both metrics. At the completion of the 4-week rotation, all students were again videotaped and evaluated. Statistical analysis was carried out using SPSS version 20 (Chicago, IL, USA). Paired t tests, Student t tests, Fisher exact, and Pearson correlations were calculated. 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed Not applicable in our study 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Not applicable in our study 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Not applicable in our study 6b) CONSORT: Any changes to trial outcomes after the trial commenced, with reasons Data was collected in an FPMRS office 7a) CONSORT: How sample size was determined 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Not applicable in our study 7b) CONSORT: When applicable, explanation of any interim analyses and stopping guidelines Videos of students performing the knot-tying tasks were viewed by two blinded female pelvic medicine and reconstructive surgery physicians who evaluated medical student proficiency using a standard knot-tying checklist (score range 0-16) and an anchored scale (range 0-20). The standard knot-tying checklist responses were 1=yes and 2=no on eight knot-tying metrics, including the following: sutures start crossed, index finger lifts suture to form loop, fingers pinch together, push suture through and grasp/tighten, hook thumb under suture, form loop, fingers pinch together, and push suture through and grasp/tighten. The anchored scale was based on a modified objective structured assessment of technical skill scale, which assigned scores from 1 to 5 on four separate procedure domains: respect for tissue, time and motion, instrument handling, and flow of operation and forward planning [20]. Higher scores represented better skills on both metrics. At the completion of the 4-week rotation, all students were again videotaped and evaluated. Statistical analysis was carried out using SPSS version 20 (Chicago, IL, USA). Paired t tests, Student t tests, Fisher exact, and Pearson correlations were calculated. 8a) CONSORT: Method used to generate the random allocation sequence Participating medical students were then randomized to either the standard curriculum ("no video" group) or to the "video" group 8b) CONSORT: Type of randomisation; details of any restriction (such as blocking and block size) Block randomization 9) CONSORT: Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Division randomly into 2 groups by random division of group 10) CONSORT: Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Study coordinator 11a) CONSORT: Blinding -If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 11a-i) Specify who was blinded, and who wasn't All evaluators were blinded 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Yes participants were aware 11b) CONSORT: If relevant, description of the similarity of interventions Not applicable in this study 12a) CONSORT: Statistical methods used to compare groups for primary and secondary outcomes Paired t tests, Student t tests, Fisher exact, and Pearson correlations were calculated.

12a-i) Imputation techniques to deal with attrition / missing values Was not an issues in this study 12b) CONSORT: Methods for additional analyses, such as subgroup analyses and adjusted analyses
Was not an issue in this study RESULTS 13a) CONSORT: For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome Of the initial 55 medical students approached for the study, three did not complete the clerkship and seven did not complete either of the videotaped tasks. Ultimately, a total of 45 medical students completed both preclerkship and postclerkship knot-tying videotaped tasks and were included in the final analysis. Participants in the nonvideo and video groups did not differ in age (mean 25.4, SD 1.8 years vs mean 25.0, SD 2.4 years; P=.46) or gender (52%, 13/24 female vs 43%, 9/24 female; P=.46) ( Table 1). Students also did not differ in their number of prior surgical rotations (P=.52) or median comfort level with knot tying at the start of the rotation (P=.55). Thirteen of 45 students (29%) in the entire cohort reported having family members who were physicians and 10 students (22%) reported planning on entering surgical fields; this did not differ between groups (P=.53 and P=.72, respectively). Additionally, preclerkship standard checklist and anchored scale scores on the knot-tying task were not significantly different (P=.90) between the two groups. 13b) CONSORT: For each group, losses and exclusions after randomisation, together with reasons Of the initial 55 medical students approached for the study, three did not complete the clerkship and seven did not complete either of the videotaped tasks. Ultimately, a total of 45 medical students completed both preclerkship and postclerkship knot-tying videotaped tasks and were included in the final analysis. Participants in the nonvideo and video groups did not differ in age (mean 25.4, SD 1.8 years vs mean 25.0, SD 2.4 years; P=.46) or gender (52%, 13/24 female vs 43%, 9/24 female; P=.46) ( Table 1). Students also did not differ in their number of prior surgical rotations (P=.52) or median comfort level with knot tying at the start of the rotation (P=.55). Thirteen of 45 students (29%) in the entire cohort reported having family members who were physicians and 10 students (22%) reported planning on entering surgical fields; this did not differ between groups (P=.53 and P=.72, respectively). Additionally, preclerkship standard checklist and anchored scale scores on the knot-tying task were not significantly different (P=.90) between the two groups.

13b-i) Attrition diagram
Not an issue in this study 14a) CONSORT: Dates defining the periods of recruitment and follow-up Between November 2015 and March 2016, 55 third-year medical students were approached at the start of their obstetrics and gynecology clerkships for inclusion in this Institutional Review Board-exempt study 14a-i) Indicate if critical "secular events" fell into the study period Not an issue in this study 14b) CONSORT: Why the trial ended or was stopped (early) Not an issue in this study 15) CONSORT: A table showing baseline demographic and clinical characteristics for each group Yes Table 1 15-i) Report demographics associated with digital divide issues