Performance Evaluation of ()
Visual inspection with acetic acid)
Trained nurses learn colposcopy and Swede scoring methods by using a fixed colposcopy or portable handColposcopy;
Compared to doctors, women.
A cross-randomized clinical trial was designed.
Set up a class to work overtime in the colposcopy clinic of Hu Shaikh mujibu Medical University (BSMMU)
DHAKA, Bangladesh.
Participants 932 women who participated in the clinic were naively screened through screening (404)
Or through positive (528)
Through other screening centers in the Dhaka area.
Intervention through trained nurses
Site in colposcopy and colposcopy method in Swede scoring system.
The Swede rating was cervical pain, margin and surface.
Vascular morphology, lesion size and iodine staining.
The women were randomly grouped and examined by a fixed colposcopy or Gynocular.
The Swede score was first obtained by a nurse and the same patient was evaluated by a doctor.
Using weighted k statistics from Gynocular and standard colposcopy to evaluate the consistency of nurses and doctors in Swede scores.
Ability to predict cin2 (
Cin2, cin3 and cervical invasive cancer)
Evaluation of Swedish scores using a receiver
Working characteristic curve.
Results The Swedish score obtained by nurses and doctors using female vaginal and fixed colposcopy was highly consistent with k statistical value 0. 858 and 0.
859, there was no difference between the cervical lesions detected in the biopsy.
39 cases of cin2 were detected by biopsy (4. 2%)women.
Conclusion our study shows that colposcopy can be performed by nurses.
Compared with doctors, there was no significant difference in the use of the Swede scoring system for cervical lesions by means of fixed colposcopy or female vaginal examination.
The Swede scores obtained by nurses using Gynocular can provide accurate cervical diagnostic methods in low-resource settings.
Test registration number isrctn53 264564.
Performance Target Evaluation of (
Visual inspection with acetic acid)
Trained nurses learn colposcopy and Swede scoring methods by using a fixed colposcopy or portable handColposcopy;
Compared to doctors, women.
A cross-randomized clinical trial was designed.
Set up a class to work overtime in the colposcopy clinic of Hu Shaikh mujibu Medical University (BSMMU)
DHAKA, Bangladesh.
Participants 932 women who participated in the clinic were naively screened through screening (404)
Or through positive (528)
Through other screening centers in the Dhaka area.
Intervention through trained nurses
Site in colposcopy and colposcopy method in Swede scoring system.
The Swede rating was cervical pain, margin and surface.
Vascular morphology, lesion size and iodine staining.
The women were randomly grouped and examined by a fixed colposcopy or Gynocular.
The Swede score was first obtained by a nurse and the same patient was evaluated by a doctor.
Using weighted k statistics from Gynocular and standard colposcopy to evaluate the consistency of nurses and doctors in Swede scores.
Ability to predict cin2 (
Cin2, cin3 and cervical invasive cancer)
Evaluation of Swedish scores using a receiver
Working characteristic curve.
Results The Swedish score obtained by nurses and doctors using female vaginal and fixed colposcopy was highly consistent with k statistical value 0. 858 and 0.
859, there was no difference between the cervical lesions detected in the biopsy.
39 cases of cin2 were detected by biopsy (4. 2%)women.
Conclusion our study shows that colposcopy can be performed by nurses.
Compared with doctors, there was no significant difference in the use of the Swede scoring system for cervical lesions by means of fixed colposcopy or female vaginal examination.
The Swede scores obtained by nurses using Gynocular can provide accurate cervical diagnostic methods in low-resource settings.
Test registration number isrctn53 264564.
Introduction cervical cancer is a common cause of cancer death in women.
Resource settings.
Recent data show that 528000 women are diagnosed with cervical cancer every year around the world, and 26 000 women die from the disease. 1 A majority (87%)
Women diagnosed with cervical cancer live in less developed regions of the world.
1 mortality varies greatly, from less than 2/100 in developed areas to more than 20/100 in areas such as Melanesia, the Middle East and Africa.
In Bangladesh, 956 new cases of cervical cancer are found each year, and 6582 women die from the disease each year.
1 In addition, with the incidence of women over 35 years of age rising sharply, cervical cancer has had a huge impact on the community at a time when the presence of women is critical to social and economic stability.
2. according to the International Agency for Cancer Research (IARC's)
It is predicted that the number of cervical cancer deaths will continue to rise in the next few decades. 1In high-
The resource setting and cervical shedding cell screening program successfully reduced the incidence of cervical cancer. 4 In many low-
In a resource environment, few women have access to a screening programme for shedding cells due to lack of national screening programmes, lack of equipment and skilled technicians.
5 results, other low-
The cost method of screening has been implemented, in which visual inspection of chance with acetic acid (VIA)
The most common method is by trained nurses and doctors.
6-8 usually, colposcopy is performed through positive women to reduce the risk of over-treatment.
The role of 6-9 colposcopy is to visually evaluate the size and range of cervical lesions with strong illumination and magnification, and to select the most abnormal lesions for biopsy. 10 In low-
Resource setting, colposcopy is usually used to assess the severity of lesions in VIA-positive women as part of the "look and treat" policy, because immediate treatment of women may be more practical if a serious lesion is diagnosed, because she may not be able to return to the clinic.
11 can also be low-
Resource settings, especially when using the Swede score system colposcopy system, the total score shows the severity of the cervical visual impression.
11-15 however, the doctor's access is limited and the limitations of the fixed colposcopy (
Need power grid and technical support)
Is why screening colposcopy in rural areas with poor infrastructure is not widely used.
11, 12, 14, 15 high-
Resource setting, nurse colposcopy teacher trained to increase the accessibility of Colposcopy and obtain diagnostic accuracy similar to doctors, 16-18, and low-18
Resource settings, diagnosis and screening via portable battery-
Driven colposcopy, Gynocular, can provide accurate, cost-
Effective and pragmatic approach to the prevention and treatment of cervical cancer.
13-15 by using the Swede scoring system colposcopy method, cervical colposcopy results can be organized and scored as a structured report for colposcopy.
12, 13 by taking the size of the lesion as a variable, the Swede score was different from that of other cervical scoring systems.
The main purpose of this study was to assess whether nurses
Led Swede at low-
The resource setting is similar to the performance of the Doctor Swede score colposcopy in detecting cervical lesions.
The second objective of this study was to assess whether a nurse or physician had similar performance compared to a fixed colposcopy to detect cervical lesions.
The third purpose of the study was to assess whether the nurse
Led Swede score colposcopy may be the future choice for detecting low cervical lesions
Resource settings.
Method Design, participants, and procedures this study was a randomized cross-clinical trial to evaluate the accuracy of biopsy used by VIA nurses trained in Swede score colposcopy methods as standard criteria for detecting cervical lesions.
In the cross-design, all women involved were randomly examined using a fixed colposcopy and Gynocular.
Nurses and doctors examined the same woman but turned a blind eye to each other's Swedish scores.
In Bangladesh, 2.
So far, 3% of women have been screened VIA, and about 4 of the women who have been screened.
8% is positive.
6 in 2004, the government of Bangladesh launched a programme to screen opportunistic approaches.
Trained caregivers, senior staff nurses and doctors provide VIA to married women aged 30 and over to detect pre-cancer and early cervical cancer in women who visit through different regional centres in Bangladesh. 18–20 VIA-
Positive women were referred to BSMMU and Government Medical School Hospital for colposcopy assessment and management.
The 18-20 cervical cancer screening program is an ongoing program and colposcopy is an important part of this prevention program.
A woman is considered to be through positive, when Sharp, unique, good
Defined, during the examination, attention was paid to the dense acetate area on the cervix, whether or not there was a raised edge, near the squamocolum junction in the transformation area.
The inclusion criteria are :(1)
Well-trained family welfare visitors, senior staff nurses and doctors in Dhaka, Bangladesh women with positive opportunistic screening of VIA are referred to as colposcopy, or women who underwent cervical screening at the colposcopy clinic of Banga Bandu Sheikh mujibu Medical University (BSMMU)
Between June 1-20 and September 31.
Other inclusion criteria are :(2)
Able to understand written and oral information ,(3)
After receiving verbal and written information from social workers, women signed an informed consent form to participate in the study.
The exclusion criteria are :(1)
Continuous vaginal bleeding ,(2)
Any gynecological examination less than 1 week before (3)pregnancy.
Women who chose not to participate in the study performed standard colposcopy.
A total of 932 women participated in the study, of which 404 women participated in naive screening and 528 women were referred to as VIA positive.
Two nurses were trained.
Prior to the start of the study, the location in the colposcopy and Swede scoring system colposcopy methods was performed for 2 weeks.
Colposcopy specialists are certified doctors or gynecologists who have been trained in colposcopy, condensation fixation, and ring electric resection at The colposcopy clinic in BSMMU.
All women in the study were examined by one of the two nurses and one of the six colposcopy specialists, and were examined with a fixed colposcopy and colposcopy.
When colposcopy is examined, one of the two standard colposcopy (
Leisegang 1DF, Leisegang, Feinmechanik-
Optik GmbH or Karl Kaps Som & Co in Berlin, Germany.
KG, Asslar/Wetzlar, Germany)
And Gynocular (
Gynius AB, Sweden, Sweden)were used.
Women were randomly assigned to 50 blocks and were examined by a nurse, followed by a doctor for a fixed colposcopy or a female colposcopy.
The same examiner then examined the woman with a second instrument to assess the performance of the agreement between the nurse, the doctor and the Swede scores of both instruments.
To reduce possible observer variability, cross-design was selected.
A total of 524 women started using a fixed colposcopy and 408 women started using a female colposcopy.
During the Swede scoring examination, each of the five colposcopy variables (
Pain, marginal surface, vascular pattern, lesion size and iodine staining)
A score of 0, 1 or 2 is given. 12–15A self-holding non-
Place the lubricated mirror in the vagina to observe the cervix.
When the nurse started the examination, the mosaic pattern, punctuation, atypical blood vessels or no blood vessels of the cervical blood vessels were examined with colposcopy or red-free (green filter)
Mode and switch meter.
The doctor then randomly evaluated the vascular pattern with two instruments.
This procedure was slightly different from the original Swede score, in which 12 points were examined for blood vessels after applying acetic acid to the cervix.
However, after the application of acetic acid, the whitening effect on the cervix slowly subsided.
Therefore, we chose to check the vascular pattern first and then apply acetic acid to ensure that both nurses and doctors have enough time to accurately estimate the vinegar effect before fading.
Therefore, the cervix was wiped for 1 min with 5% acetic acid, and then the nurse evaluated the three Swede scoring variables (
Pain, margin, surface and lesion size)
The nurse scored with two instruments and then by the doctor.
Next, wipe the cervix with 5% Lugo iodine solution, and the nurse scored the fifth variable of the Swede score (Iodine staining)
Both devices are random and then performed again by the doctor.
The nurse and the doctor studied the nurse in a separate direction and reported the results of the examination.
Other examiners could not hear the report and could not see the results of the former examiner.
Nurses and doctors are also not allowed to communicate the patient's examination results.
After the examination was completed, one or more biopsies were performed from areas suspected of cervical lesions.
All women with Doctor scores ≥ 4, 12, 13 were given cervical punch biopsy, 15. since doctors using Swede scores have been validated and biopsy is recommended at Swede scores of 6 points and above, 12 points, 13 points, this study aims to validate nurse colposcopy
Resource Settings (
Not verified before. .
Cervical biopsy was analyzed in BSMMU pathology laboratory.
The pathological diagnosis was graded according to the cin classification system and used as a gold standard.
22 women with CIN1 lesions were given the option of direct treatment or follow-up
Review after 6 months
The women in CIN2 underwent a circular electric resection.
Women with invasive cervical cancer were referred to the BSMMU gynecological oncology unit for management.
The study was approved by the local ethics committees of Bangladesh and Sweden: the institutional review committee of BSMMU;
Dnr BSMMU/2012/3176 and regional ethics review committee of Stockholm; Dnr 2012/545-31/1.
The study was registered as isrctn53 264564 after the participant registration started, due to the release restriction of the Gynocular parallel patent application process.
The research program can be visited in the Department of Obstetrics and Gynecology of dandui Hospital in Stockholm, Sweden. The Gynocular (
Gynius AB, Sweden, Sweden)
It is a high-resolution single-eye colposcopy similar to the fixed colposcopy specifications.
Month, month Gynocular is a small, handmadeheld, battery-
Drive, 166mm focal length measurement 50 × 33 × 300mm, magnification 5 ×, 8 ×, 12 ×.
14, 15 it has a tripod mounting clip that can secure the screws to any standard tripod, allowing medical professionals to do colposcopy with their hands
Free mode for easy biopsy (figure 1).
The Gynocular has high qualityIntensity Light-
LEDs for warm white lighting, green filter, powered by rechargeable lithiumion battery.
This is approved by the Swedish National Drug Administration.
Invasive medical diagnostic class I Tools approved by CE marking and Food and Drug Administration.
Download figureOpen in new tabDownload powerpoint Figure 1 and fix the tripod on any standard tripod using a tripod mounting clip.
All statistical analyses are performed using r v. 2. 14.
23 The mean and SD of continuous variables and the absolute and relative frequency of classified variables were used to summarize the baseline patient features of women.
To test the degree of consistency between colposcopy and women, percentage consistency and weighted k statistics were calculated.
24 cervical lesions were classified using Gynocular and fixed colposcopy with Swede scoring system.
The detection rates of Cin1, cin2, cin3 and ICC were 12-15 (
Cervical cancer), AIS (
In situ adenocarcinoma)
, Calculate the benign cervix and cervical tuberculosis in the cervical punch biopsy.
The positive biopsy results are defined as CIN2 (
Cin2, cin3)
We calculated the sensitivity, specificity, positive predictive value of Swede scores (PPV)
And negative predictive value (NPV)
Use biopsy as the gold standard for all cuts
The doctor's Swedish score is between 4 and 10, and the nurse's score is between 0 and 10.
The results are characterized by table and receiver work (ROC)
The curve and the area under the curve (AUC).
ROC curve AUC comparison was performed using roc.
Test function in Package.
Sample size estimated sample size based on the expected number of positive biopsy results (
Defined as CIN2)
Not in terms of statistical capacity.
In Bangladesh, previously unscreened population in Bangladesh did not have published data on CIN2, which was validated by cell examination, Colposcopy and biopsy, and only CIN2 was confirmed by positive women.
However, data from India show that this ratio is 2.
CIN2 + was 7% of women who were not screened.
25 therefore, we assume that interest rates in Bangladesh are similar and that CIN2 is expected to be 2.
There are 5% innocent women and 7. 5% in VIA-
500 positive female samples of naive and 500
Positive Women will produce 50 positive biopsy results, which are considered to have sufficient accuracy for the accuracy of the nurse's colposcopy physician and the Swedish score compared to the doctor.
The goal is therefore to include some 1000 women.
In a retrospective power analysis based on the results of this study, we estimate that approximately 1500 biopsies are required (
Compared with 228 biopsies in women who scored higher than 4 points in Sweden in this study)
The difference between 80% power detection is 0.
At the significance level of 5%, AUC of ROC curve was 05.
Design, participants and procedures this study is a randomized cross-clinical trial to assess the accuracy of VIA nurses trained in Swede score colposcopy methods in detecting cervical lesions using biopsy as a standard.
In the cross-design, all women involved were randomly examined using a fixed colposcopy and Gynocular.
Nurses and doctors examined the same woman but turned a blind eye to each other's Swedish scores.
In Bangladesh, 2.
So far, 3% of women have been screened VIA, and about 4 of the women who have been screened.
8% is positive.
6 in 2004, the government of Bangladesh launched a programme to screen opportunistic approaches.
Trained caregivers, senior staff nurses and doctors provide VIA to married women aged 30 and over to detect pre-cancer and early cervical cancer in women who visit through different regional centres in Bangladesh. 18–20 VIA-
Positive women were referred to BSMMU and Government Medical School Hospital for colposcopy assessment and management.
The 18-20 cervical cancer screening program is an ongoing program and colposcopy is an important part of this prevention program.
A woman is considered to be through positive, when Sharp, unique, good
Defined, during the examination, attention was paid to the dense acetate area on the cervix, whether or not there was a raised edge, near the squamocolum junction in the transformation area.
The inclusion criteria are :(1)
Well-trained family welfare visitors, senior staff nurses and doctors in Dhaka, Bangladesh women with positive opportunistic screening of VIA are referred to as colposcopy, or women who underwent cervical screening at the colposcopy clinic of Banga Bandu Sheikh mujibu Medical University (BSMMU)
Between June 1-20 and September 31.
Other inclusion criteria are :(2)
Able to understand written and oral information ,(3)
After receiving verbal and written information from social workers, women signed an informed consent form to participate in the study.
The exclusion criteria are :(1)
Continuous vaginal bleeding ,(2)
Any gynecological examination less than 1 week before (3)pregnancy.
Women who chose not to participate in the study performed standard colposcopy.
A total of 932 women participated in the study, of which 404 women participated in naive screening and 528 women were referred to as VIA positive.
Two nurses were trained.
Prior to the start of the study, the location in the colposcopy and Swede scoring system colposcopy methods was performed for 2 weeks.
Colposcopy specialists are certified doctors or gynecologists who have been trained in colposcopy, condensation fixation, and ring electric resection at The colposcopy clinic in BSMMU.
All women in the study were examined by one of the two nurses and one of the six colposcopy specialists, and were examined with a fixed colposcopy and colposcopy.
When colposcopy is examined, one of the two standard colposcopy (
Leisegang 1DF, Leisegang, Feinmechanik-
Optik GmbH or Karl Kaps Som & Co in Berlin, Germany.
KG, Asslar/Wetzlar, Germany)
And Gynocular (
Gynius AB, Sweden, Sweden)were used.
Women were randomly assigned to 50 blocks and were examined by a nurse, followed by a doctor for a fixed colposcopy or a female colposcopy.
The same examiner then examined the woman with a second instrument to assess the performance of the agreement between the nurse, the doctor and the Swede scores of both instruments.
To reduce possible observer variability, cross-design was selected.
A total of 524 women started using a fixed colposcopy and 408 women started using a female colposcopy.
During the Swede scoring examination, each of the five colposcopy variables (
Pain, marginal surface, vascular pattern, lesion size and iodine staining)
A score of 0, 1 or 2 is given. 12–15A self-holding non-
Place the lubricated mirror in the vagina to observe the cervix.
When the nurse started the examination, the mosaic pattern, punctuation, atypical blood vessels or no blood vessels of the cervical blood vessels were examined with colposcopy or red-free (green filter)
Mode and switch meter.
The doctor then randomly evaluated the vascular pattern with two instruments.
This procedure was slightly different from the original Swede score, in which 12 points were examined for blood vessels after applying acetic acid to the cervix.
However, after the application of acetic acid, the whitening effect on the cervix slowly subsided.
Therefore, we chose to check the vascular pattern first and then apply acetic acid to ensure that both nurses and doctors have enough time to accurately estimate the vinegar effect before fading.
Therefore, the cervix was wiped for 1 min with 5% acetic acid, and then the nurse evaluated the three Swede scoring variables (
Pain, margin, surface and lesion size)
The nurse scored with two instruments and then by the doctor.
Next, wipe the cervix with 5% Lugo iodine solution, and the nurse scored the fifth variable of the Swede score (Iodine staining)
Both devices are random and then performed again by the doctor.
The nurse and the doctor studied the nurse in a separate direction and reported the results of the examination.
Other examiners could not hear the report and could not see the results of the former examiner.
Nurses and doctors are also not allowed to communicate the patient's examination results.
After the examination was completed, one or more biopsies were performed from areas suspected of cervical lesions.
All women with Doctor scores ≥ 4, 12, 13 were given cervical punch biopsy, 15. since doctors using Swede scores have been validated and biopsy is recommended at Swede scores of 6 points and above, 12 points, 13 points, this study aims to validate nurse colposcopy
Resource Settings (
Not verified before. .
Cervical biopsy was analyzed in BSMMU pathology laboratory.
The pathological diagnosis was graded according to the cin classification system and used as a gold standard.
22 women with CIN1 lesions were given the option of direct treatment or follow-up
Review after 6 months
The women in CIN2 underwent a circular electric resection.
Women with invasive cervical cancer were referred to the BSMMU gynecological oncology unit for management.
The study was approved by the local ethics committees of Bangladesh and Sweden: the institutional review committee of BSMMU;
Dnr BSMMU/2012/3176 and regional ethics review committee of Stockholm; Dnr 2012/545-31/1.
The study was registered as isrctn53 264564 after the participant registration started, due to the release restriction of the Gynocular parallel patent application process.
The research program can be visited in the Department of Obstetrics and Gynecology of dandui Hospital in Stockholm, Sweden. The Gynocular (
Gynius AB, Sweden, Sweden)
It is a high-resolution single-eye colposcopy similar to the fixed colposcopy specifications.
Month, month Gynocular is a small, handmadeheld, battery-
Drive, 166mm focal length measurement 50 × 33 × 300mm, magnification 5 ×, 8 ×, 12 ×.
14, 15 it has a tripod mounting clip that can secure the screws to any standard tripod, allowing medical professionals to do colposcopy with their hands
Free mode for easy biopsy (figure 1).
The Gynocular has high qualityIntensity Light-
LEDs for warm white lighting, green filter, powered by rechargeable lithiumion battery.
This is approved by the Swedish National Drug Administration.
Invasive medical diagnostic class I Tools approved by CE marking and Food and Drug Administration.
Download figureOpen in new tabDownload powerpoint Figure 1 and fix the tripod on any standard tripod using a tripod mounting clip.
All statistical analyses are performed using r v. 2. 14.
23 The mean and SD of continuous variables and the absolute and relative frequency of classified variables were used to summarize the baseline patient features of women.
To test the degree of consistency between colposcopy and women, percentage consistency and weighted k statistics were calculated.
24 cervical lesions were classified using Gynocular and fixed colposcopy with Swede scoring system.
The detection rates of Cin1, cin2, cin3 and ICC were 12-15 (
Cervical cancer), AIS (
In situ adenocarcinoma)
, Calculate the benign cervix and cervical tuberculosis in the cervical punch biopsy.
The positive biopsy results are defined as CIN2 (
Cin2, cin3)
We calculated the sensitivity, specificity, positive predictive value of Swede scores (PPV)
And negative predictive value (NPV)
Use biopsy as the gold standard for all cuts
The doctor's Swedish score is between 4 and 10, and the nurse's score is between 0 and 10.
The results are characterized by table and receiver work (ROC)
The curve and the area under the curve (AUC).
ROC curve AUC comparison was performed using roc.
Test function in Package.
Sample size estimated sample size based on the expected number of positive biopsy results (
Defined as CIN2)
Not in terms of statistical capacity.
In Bangladesh, previously unscreened population in Bangladesh did not have published data on CIN2, which was validated by cell examination, Colposcopy and biopsy, and only CIN2 was confirmed by positive women.
However, data from India show that this ratio is 2.
CIN2 + was 7% of women who were not screened.
25 therefore, we assume that interest rates in Bangladesh are similar and that CIN2 is expected to be 2.
There are 5% innocent women and 7. 5% in VIA-
500 positive female samples of naive and 500
Positive Women will produce 50 positive biopsy results, which are considered to have sufficient accuracy for the accuracy of the nurse's colposcopy physician and the Swedish score compared to the doctor.
The goal is therefore to include some 1000 women.
In a retrospective power analysis based on the results of this study, we estimate that approximately 1500 biopsies are required (
Compared with 228 biopsies in women who scored higher than 4 points in Sweden in this study)
The difference between 80% power detection is 0.
At the significance level of 5%, AUC of ROC curve was 05.
As a result, a total of 932 women were included in the study, of which 404 (43%)
Too naive.
Table 1 lists the baseline features of women.
A doctor scored at least 4 points in Sweden for 256 women, of whom 228 did a biopsy and 28 refused a biopsy (
Excluded from ROC analysis). Fifty-
Nine biopsies were performed outside the study protocol (
Excluded from ROC analysis). Twenty-
CIN2 was found in 7 VIA positive women and CIN2 was found in 5 naive women.
Seven benign punching biopsy (1. 8%)
23 cases of chronic vaginitis (5. 8%), CIN1 in 19 (4. 8%)and CIN2 in 4 (1. 0%).
No women have CIN3 and cin4 (1. 0%)had ICC (CIN3+). In 1 (0. 2%)
Her biopsy showed tuberculosis.
Swedes scored below 342 points (85. 5%)
Women, no biopsy was performed in these women.
View this table: View inline View pop-up table 1 baseline features in the following ways
In positive women, 13 cases were benign by puncture biopsy (2. 5%)
82 cases of chronic vaginitis (15. 7%), CIN1 in 90 (17. 3%)
CIN2 in 21 years (4%). Four women (0. 8%)
There are CIN3 and 6 (1. 2%)had ICC (CIN3+). Two (0. 4%)
Women had tuberculosis in their biopsies. In 303 (57. 4%)
In women, the Swedish score was