Surgical training needs to evolve in line with the legislated restriction of trainee doctors’ working hours and patient safety concerns. Medical regulatory bodies have identified a reduction in exposure to clinical procedures after these working time restrictions and have highlighted the importance of innovative methods of training.1 Evidence suggests that procedural skills can be learned through the use of simulation models,2–5 but the fidelity or “realism” of the models can vary widely, depending on cost and ethical implications. These repercussions have led to the development of low-fidelity models.6,7 Grober et al2 (2004) undertook a randomized control trial of 50 novice surgical residents who had hands-on training with either high- or low-fidelity models and found no significant difference (t38 = 1.16, P = 0.25) in the acquisition of technical skill when objectively assessed on the high-fidelity models.
Cervical biopsy is a diagnostic technique that should be undertaken when a recognizably atypical cervical lesion is visualised.8 The positive predictive value for invasion after cervical punch biopsy has been quoted at 83%,9 whereas cytology has a positive predictive value of 56%.10 Undertaking a cervical biopsy in a gynecology outpatient setting will therefore improve diagnostic yield and reduce time between presentation and treatment of a cervical cancer.
The World Health Organization reports that worldwide cervical cancer is the second commonest female cancer11 and all grades of gynecology trainees will review referrals for “a suspicious cervix” or irregular bleeding patterns. Major complications such as inpatient admission for bleeding are rare consequences of cervical biopsy, but an understanding and application of hemostatic measures is required, particularly in cases of frank malignancy. A prospective observational study12 found that 79% of women reported bleeding, of whom 21.4% described severe bleeding, after the procedure. Learning this procedure is therefore a valuable use of training time because correct technique is vital for completing the biopsy and managing complications.
Training for gynecology residents to undertake minor cervical procedures follows the old adage of “learning by doing,” which because of the invasiveness of the procedure is becoming less acceptable to women.13,14 The use of a simulation model to teach cervical biopsy will optimize patient safety by obtaining this basic skill away from the clinical environment, thereby improving patient safety and experience.
Studies looked at the learning curve and training aspects of colposcopy using high-fidelity models compared with clinical performance in the colposcopy setting and found that competence levels were comparable, as was educational value.3,15 However, no studies to date have looked at low-fidelity models to teach cervical punch biopsies. Low-fidelity sourcing could provide a cost-effective training alternative, which will help achieve educational competencies without compromising patients.
This study describes the construction of a low-fidelity cervical biopsy model and its value as an educational training model.
Construction of the Model
We constructed 5 models using cardboard boxes (25 × 15 × 8 cm), toilet rolls, brown paper, stones, sponge backing from discarded suturing sets, sticky tape, and a permanent marker (Fig. 1). Qualitative data were gathered from expert colposcopists who subjectively rated different materials for authenticity including foam, plasticine, and rubber.
A hole to fit the toilet roll was cut half way up the box, stones were placed in the bottom to weight it, and it was wrapped in brown paper. The sponge was cut to fit inside the back of the toilet toll, a central 5-mm core was removed to represent the cervical os, and a “transformation zone” was painted onto the sponge (Figs. 2 and 3). This sponge was then taped just inside the back of the toilet roll. The models were easily portable.
The total time for construction of the 5 models was approximately 1 hour. There was no cost for the reusable items, which were easily sourced from household waste. The remaining materials (tape, pens, sponge) were easily accessible from the department and cost nothing.
Twenty-one obstetric and gynecology doctors attended a regional study day, of whom 18 (86%) were eligible for enrollment. Certified colposcopists were excluded from the study. All trainees undertook a cervical biopsy workshop, but only those who had signed a consent form before the day were enrolled. Participants completed a baseline questionnaire, which detailed level of training and previous experience with cervical biopsies and colposcopy.
Two hours of interactive lectures included anatomy, physiology, pictures of normal and abnormal cervices, but no procedural-based information. The photographs demonstrated gross abnormalities viewed without the aid of acetic acid or iodine as noncolposcopy trainees would not have access to this. This provided the gynecology trainees with a basic understanding of recognition of an abnormal transformation zone and where to take a biopsy from.
The participants were divided into 5 groups of 4 trainees, and certified colposcopists demonstrated the instruments and procedure in 20 minutes. Equipment provided included the training model, a Cusco’s speculum, Eppendorfer and Tischler biopsy forceps, silver nitrate sticks, swabs with Monsell’s solution, and a hemostatic tampon (Fig. 4). A Crib sheet was given to all demonstrators outlining the learning objectives to be covered so that training could be standardized. These included the following:
- Patient safety and dignity (gain consent, chaperone, hygiene).
- Set-up of equipment before beginning procedure.
- Biopsy forceps (Eppendorfer, Tischler): illustrate the benefits and disadvantages of different forceps such as size and fragmentation of the tissue samples.
- Visualize the cervix and transformation zone
- Undertake biopsy from most abnormal area—use cervical atlas pictures from the lectures as a guide.
- Check biopsy for fragmentation and size
- Application of silver nitrate and Monsell’s solution
- Description of additional hemostatic measures such as diathermy or sutures in the event of continuing blood loss
- Postprocedural advice
All participants were given direct and then indirect hands-on model training, and demonstrators were asked to ensure that all trainees completed each of the learning objectives on the Crib sheet. Each group was given 1 hour to practice the skill (Fig. 5). Application of knowledge learned in the orientation phase was applied in the training phase: if the transformation zone was not visible, trainees were encouraged to take a smear with a broom and brush to sample a potential endocervical lesion. Endocervical curettage is not routinely undertaken by general gynecologists or colposcopists in the UK, so this was not a learning objective for the workshop.
Participants completed a course evaluation form detailing the learning value of the workshop: a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree) documented confidence in performing a cervical biopsy and the usefulness of the workshop in acquiring this skill. Participants completed a pre– and post–multiple-choice test, which assessed knowledge of site of biopsy, instruments used, hemostatic measures, and postprocedural advice. A maximum of 15 points could be scored, and a team of certified colposcopists composed the questions from national guidelines.8 The aim of this test (see e-appendix) was to assess whether the workshop improved trainee’s knowledge of the procedural steps.
Participant numbers were used so that prequestionnaires and postquestionnaires could be paired for statistical analysis. Statistical analysis was undertaken using Graphpad Prism 6 software. A t test assessed the paired, parametric continuous data. Descriptive statistics looked at the mean, range, and SD. A multivariate regression model was computed to assess whether the training effect was independent of participant’s previous experience or level of training.
Details of Ethics Approval
Ethical approval for NHS staff is no longer required under NRES regulations (Governance Arrangements for Research Ethics Committees—changes to the Research Ethics Committees, v 1.1, March 2012 from www.nres.nhs.uk). Approval for the study was given by the Severn School of Obstetrics and Gynecology who had organized the colposcopy study day. In concordance with the World Medical Association Declaration of Helsinki, the health of patients was safeguarded by training on bench models. The research participants’ confidentiality was protected by adherence to the Caldicott Principles, Data Protection Act, and the Human Rights Act. Information leaflets sent before the study provided contact details and outlined the benefits of enrollment. Participants submitted consent forms giving permission to take part in the study and store their data 2 weeks before the study day. Participants could withdraw at any point.
Of the 18 eligible participants, 10 (55%) were in years 1 to 2 of their specialty training, 6 (34%) were in years 3 to 5, and 2 (11%) were in years 6 to 7. Eleven (61%) had undertaken 0 to 3 cervical biopsies, 4 (22%) had completed 4 to 6 biopsies, 1 (5.5%) had undertaken 7 to 9 biopsies, and 2 (11.5%) had undertaken more than 10 biopsies (Table 1 for the baseline characteristics).
One hundred percent of trainees completed the course evaluation. All participants strongly agreed that “a cervical punch biopsy simulation model is a useful teaching tool” and “learning was enhanced compared to didactic lectures alone.” Ninety-five percent of the participants strongly agreed that their procedural learning needs were met; one participant stated they would have liked to practice suturing as a hemostatic measure. Participants graded the value of the training in preparing them to perform cervical biopsies from no relevance (1) to highly relevant (5). The mean score was 4.7 of 5 (SD 0.42; 95% CI 4.49–4.90), with 100% of participants expecting to undertake cervical punch biopsies in the future. Table 2 includes the questions asked of the participants relating to their confidence and subsequent results. Multivariate analysis revealed that the confidence effect was dependent on the participant’s previous level of training (P = 0.02).
Qualitative analysis revealed which aspects of the training participants considered the most valuable such as “discussing and practising hemostatic measures before undertaking on a real patient has decreased my anxiety in undertaking this in an outpatient environment” and “learning the technique on a model and becoming familiar with the instruments, I feel more prepared to undertake on a patient now.”
Six expert colposcopists evaluated the model. The foam was the most difficult to biopsy, a tearing motion/technique was required, which led to a small (1–2 mm), crushed or fragmented sample. Experts felt that this would increase patient discomfort and reduce histologic adequacy. The plasticine was also difficult to biopsy—it was tricky to gain traction with the forceps; in a warm room, it became too malleable and the biopsy became fragmented (approximately 1 mm). The sponge provided the most realistic traction and the least fragmented biopsies (3–5 mm). One reviewer felt that the lack of bleeding from the biopsy site was a limitation to the realism and suggested partially soaking the sponge in red dye.
Scores for knowledge of the procedural steps were significantly higher after the workshop (P < 0.0001). Mean scores previously were 7.33 of 15 (48%; SD, 1.23; 95% CI, 6.71–7.94) versus a mean of 11.9 after the workshop (79%; SD, 1.79; 95% CI, 11.0–12.7). Mean scores and range are shown in Figure 4. Effect size was calculated and showed a strong positive linear relationship (r = 0.83; 95% CI, 0.74–0.92). Multivariate analysis revealed that the training effect was independent of participant’s previous experience (P = 0.648) and level of training (P = 0.968).
This study has illustrated the significant educational value of a low-fidelity simulation workshop in teaching an outpatient gynecologic procedure. Multivariate analysis suggested a weak correlation between the training effect and level of training or experience and therefore could be used for level of training or experience and therefore could be used for continuing clinical development as well as with novice trainees.
Current evidence has reported the reliability and validity of bench model training for surgical techniques. In a gynecology setting, studies have focused on laparoscopic and hysteroscopic techniques.4–7,16,17 Educational studies have shown that exposure to clinical procedures have been reduced after working time restrictions, and with the ever increasing capacity of patients in clinics, clinical effectiveness (safety and efficiency) can be affected by trainee’s poor confidence in undertaking outpatient procedures. Proficiency and confidence, gained through a simulation training scheme, can then be consolidated by the transference of these skills to a clinical setting.
Indeed, the qualitative component of the survey gave a greater depth of understanding to the value of the training. After the publication of the Francis Report, patient safety is at the forefront of clinicians’ clinical practice. The informal environment allowed participants to learn a procedural skill without compromising patients or causing embarrassment to the trainee or woman. Responses from the formal structured feedback by the Severn Deanery indicated that all participants felt that the workshop was a valuable educational experience and the combination of aural, visual, and kinesthetic stimuli that the workshop provided appealed to all types of learners.
By essentially using waste products to make the models, no cost was incurred by the training faculty. This has led to the development of an environmentally friendly product that can reduce concerns over patient safety, high costs, and rigid training scheduling. Some sacrifice of realism will be made with low-fidelity models, but this is replaced by reproducibility, portability, and multiple training opportunities. With 85% of cervical cancer deaths in the developing world resulting from limited access to any form of effective screening and or training,11 unskilled health care workers could be trained to take biopsies with the use of a colposcopy atlas and a low-fidelity model.
Evidence is poor with regard to whether bench model training leads to the maintenance of these skills or an improvement in clinical outcomes. Preferably a randomized control trial should be undertaken because a small sample size can generate Type 1 errors and makes the generalizability of the study harder to determine, but this has been proven to be difficult because formal teaching of cervical punch biopsies for gynecology trainees is undertaken on an ad hoc basis.
This novel low-fidelity cervical biopsy model is easy to construct, can be easily transported, and is low cost, which would be of particular use in low-resource countries. Trainees reported significant educational value in practicing this technique before patient contact. Future research should focus on whether low-fidelity cervical punch biopsy models improve performance in the clinical setting by, for example, reducing time between referral and diagnosis of a cervical cancer.
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APPENDIX: Cervical Biopsy Procedural Knowledge Test
- Where on a cervix should a punch biopsy preferably be taken? (Circle answer.)
Transformation zone Ectocervix Endocervix Squamocolumnar junction
- 2. With regard to cervical biopsy forceps (tick the correct answer):
- 3. If the transformation zone is not visible, sampling of the endocervix should preferably be done with… (Circle answer.)
Endocervical Curettage Course of estrogen Cytobrush
- 4. Prioritize hemostatic measures following a cervical biopsy:
- 5. With regard to postprocedural advice (tick the correct answer):
Score: / 15