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A pilot analysis of multispectral digital colposcopy for women with high-grade squamous intraepithelial lesion (HGSIL) Pap smear results
Gynecologic Oncology 107 (2007) S83 – S85 www.elsevier.com/locate/ygyno
Conference Report
A pilot analysis of multispectral digital colposcopy for women with high-grade squamous intraepithelial lesion (HGSIL) Pap smear results Keywords: Cervical cancer; Imaging; Fluorescence; Pain; Anxiety; Pain satisfaction
Cervical cancer remains an important health problem for women in the U.S. and internationally, despite the widespread use of a screening test (the Papanicolaou smear) and effective means of treating precancerous lesions. This is due in part to limitations in both the screening test and the treatment process. The Papanicolaou smear has low sensitivity and specificity; thus cases of dysplasia or cancer are missed and women with normal tissue undergo unnecessary evaluation and treatment procedures. Also, the evaluation and treatment process for an abnormal screening test is lengthy and requires multiple visits, making adherence problematic. For example, recent evidence has shown that the accuracy of follow-up colposcopy is highly operatordependent (90% sensitivity and 50% specificity) with highly experienced gynecologic colposcopists at a comprehensive cancer center. In contrast, the ALTS trial reported sensitivities of approximately 50% for colposcopy either immediately or as part of the standard of care, called conservative management with less experienced colposcopists [1]. Researchers are developing innovative cervical cancer screening and diagnostic technologies in order to improve current practice. One such technology is the use of fluorescence and/or reflectance spectroscopy. For example, the laser-induced fluorescence endoscopy (LIFE) device demonstrated a sensitivity of 69% and specificity of 70% to detect high-grade dysplasia in patients at high-risk for lung cancer [2], and the visually enhanced lesion scope (VELScope) achieved a sensitivity of 98% and a specificity of 100% in the detection of oral cancer in 44 dental patients [3]. Our group is testing a research version of a fluorescent macroscopic device called the multispectral digital colposcope (MDC) to be used in the detection of cervical dysplasia. In a pilot test with 29 high-grade squamous intraepithelial lesion (HGSIL) patients, the MDC achieved a sensitivity of 79% and a specificity of 88% (unpublished data under review). It images the entire field of the cervix and records a limited number of spectrally distinct fluorescence, reflectance and polarized reflectance images.
doi:10.1016/j.ygyno.2007.07.046
Patient receptivity to the MDC is unknown. We undertook a pilot study of 14 participants to compare patient pain, anxiety and satisfaction ratings of the MDC, Pap smear test, colposcopy, and biopsy. The results from these comparisons can then be used for the future refinement of the design of the MDC to heighten patient adherence to post Pap smear follow-up care. Method Fourteen colposcopy patients with a Cin Grade 2 or 3 Papanicolaou smear result were referred to the Gynecologic Oncology Clinic at the University of Texas M.D. Anderson Cancer Center (UTMDACC) or to the Harris County Hospital District Lyndon Baines Johnson Hospital Clinic in Houston Texas. Women were eligible for this pilot study if they were over the age of 18, were referred for an abnormal Papanicolaou smear result, were not pregnant, and able to communicate in English, Spanish or Chinese. UTMDACC sees primarily white, insured patients. The Harris County Hospital District Lyndon B. Johnson Hospital Clinic sees a tri-ethnic group of patients (white, African-American, and Hispanic) who are typically uninsured or with Medicaid. After obtaining informed consent, participants met with the research assistant to discuss the pilot study. Prior to their examination procedures in the colposcopy clinic, each woman was given a brief explanation of the Papanicolaou smear test, cervical biopsy, colposcopy and the MDC. Immediately afterward, women were asked to explain in their own words what the MDC procedure entailed, as well as their pre-exam opinion of the MDC, if any. The research assistant then accompanied the patient to the examination. During the examination, the research assistant assessed patient ratings immediately following each of the these procedures, which were conducted in the following order: vaginal exam, speculum insertion, lateral wall retractor insertion, first MDC, acetic acid (vinegar) contrast agent application, second MDC, colposcopy, lidocaine injection, and biopsy. Patients were asked to rate the anxiety and pain caused by the procedure. The rating for each variable was a one-item measure, i.e., 0 = not at anxious to 10 = extremely anxious. These rating scales were explained to the patient at the beginning of the appointment prior to the examination and a response card was given to the participant as the research assistant read the questions out loud. In addition, the number of their vocalizations uttered during each procedure, as well as nonverbal expressions such as flinching, were recorded during each procedure. Shortly after the examination was completed, each participant was then assessed in a separate consultation room with the behavioral interviewer, who verbally assessed the participant's perceptions of each procedure using an 11item, 3-point questionnaire. This satisfaction questionnaire assessed patients'
S84
Conference Report
Table 1 Pain and anxiety ratings during exam
# of vocalizations Pain (0–10) Anxiety (0–10)
Vaginal exam
Speculum insertion
Lateral wall retractor insertion
1st MDC
Vinegar application
Colposcopy
2nd MDC
Injection lidocaine
Biopsy
0.10 1.42 2.00
0.61 3.15 3.62
0.42 3.42 4.08
0.50 0.92 1.25
0.83 1.08 1.42
0.58 1.67 3.00
0.08 1.42 2.58
3.08 4.46 5.69
0.25 0.21 2.33
perceptions of pain, being frightened whether the doctors answered questions about the procedure to their satisfaction, whether the healthcare providers were gentle during the procedure. Mean ratings for each procedure are presented in Table 1. During the post-exam interview, participants were also asked to rate various aspects of the MDC and biopsy procedures. These results are presented in Table 2. Patients were also asked whether they liked anything about having the MDC procedure and whether they disliked anything about the procedure. Finally, participants were asked about their perceptions of positive and negative predictive value of the MDC and of biopsy on a 4-point Likert scale, ranging from very likely to probably, to maybe, to unlikely. For Spanish-speaking participants, the interviewer, who is bilingual, conducted the interviews in Spanish and used translated and validated Spanish versions of the satisfaction questionnaires.
Results During exam The results indicate that, with the exception of the application of the acetic acid contrast agent, both the first and second MDC procedures were less painful and anxiety provoking than all other procedures. The first MDC procedure, conducted before the vinegar application, was the least painful Table 2 Patient satisfaction (immediately post-exam)
1. Did the nurse/doctor explain what would be done in a way you could understand? 2. Was the nurse/doctor gentle? 3. Were you uncomfortable (reverse-coded)? a 4. Did it take too long (reverse-coded)? a 5. Did the nurse/doctor answer your questions? 6. Did the nurse/doctor seem to know what she was doing? 7. Was the procedure frightening (reverse-coded)? a 8. Did you find the instruments used for this test frightening (reverse-coded)? a There were too many people in the room (reverse-coded) a The procedure was painful (reverse-coded) a For the MDC: Was the vinegar application uncomfortable (sting, burn or cold; reverse-coded)? a For the biopsy: Did you like the lighting in the room during the test?
of all the procedures, with the exception of the biopsy, which was done under local anesthesia. The lidocaine injections received the highest pain and anxiety ratings during the exam. The anxiety rating for the first MDC procedure was the lowest of all procedures. For the second MDC, average pain and anxiety ratings increased after the vinegar application and colposcopy procedures. Post-exam The results show that overall the MDC was well tolerated by the participants. For most participants, the application of the vinegar contrast agent was the most painful aspect of the MDC procedure. The other main source of dissatisfaction with the MDC was the presence of the study personnel, such as engineers in the room. Compared with their perception of colposcopy, the average ratings for anxiety regarding the procedure and the instruments used for the procedure were lower for MDC. Similarly, the average ratings for the pain associated with the MDC were lower than that of the biopsy. Perceptions of accuracy Immediately post-exam, participants were asked to rate their perception of the positive predictive values as well as the false positive rate of the MDC and biopsy. For both procedures, participants were asked two questions. The first question asked, “If you had abnormal cells on your cervix, do you think this test will find them?” and “If you don't have abnormal cells on your cervix, do you think this test will show a normal result?” Participants were asked to rate their responses on a 0 to 4 scale, with 4 being “definitely yes”, 3 being “ probably yes”, 2 being “maybe yes” 1 being “probably no”, and 0 being “definitely no”. In general, the participants tended to rate the MDC's ability to positively detect abnormal cells as just lower than that of biopsy, 3.08 vs. 3.67. In regard to their perception of the MDC's false positive rate, participants again rated the MDC as less accurate than that of biopsy, 2.92 vs. 3.5.
Overall post-exam perception of MDC
Biopsy
2.00
1.92
1.92 1.75 1.92 2.00
1.92 1.67 1.92 1.92
1.83
2.00
1.42
1.42
1.58
1.16
1.42
1.42
Discussion
1.75 1.08
1.33
This pilot test shows that in general, the patients are highly satisfied with the MDC and seem to be more satisfied with this diagnostic procedure compared to biopsy and colposcopy. Their ratings of perceived accuracy of the MDC are slightly lower than that of biopsy, but still within the range of the perceived accuracy of biopsy. Two assessments of pain and anxiety ratings were done with the MDC, prior to the vinegar application and
1.75
a These items were reverse-coded so that the higher ratings indicated beneficial responses.
Conference Report
after. The MDC ratings tended to be higher after the vinegar application, but still not as high as that of the pain ratings associated with the lidocaine injection which is administered immediately before biopsy. The results of this pilot test indicate that it is important to separate patients' perceptions of the contrast agent application from the actual procedure of the MDC itself. Based on the favorable results comparing the MDC with colposcopy and biopsy procedures, this pilot also indicates that the MDC has the potential to engender high patient adherence to follow-up diagnostic procedures after an abnormal Pap smear result. Conflict of interest statement We declare that we have no conflict of interest.
References [1] Group TA-LTSA. A randomized trial on the management of low-grade squamous intraepithelial lesion cytology interpretations. Am J Obstet Gynecol 2003;188:1383–13892.
S85
[2] Hirsch F, Prindiville S, Miller Y, Franklin W. Fluorescence versus whitelight bronchoscopy for detection of preneoplastic lesions: a randomized study. JNCI 2001;93(18):1385. [3] Lane P, T. G., P.W., H.Z., C.P., S.N. Simple device for the direct visualization of oral-cavity tissue fluorescence. J Biomed Optic 2006; 11(2):024006.
E. Shinn* T. Le J. Gallegos K. Basen-Engquist Department of Behavioral Science, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd. Unit 193, Houston, TX 77030, USA E-mail address: [email protected]. *Corresponding author. 6 July 2007
Conference Report
A pilot analysis of multispectral digital colposcopy for women with high-grade squamous intraepithelial lesion (HGSIL) Pap smear results Keywords: Cervical cancer; Imaging; Fluorescence; Pain; Anxiety; Pain satisfaction
Cervical cancer remains an important health problem for women in the U.S. and internationally, despite the widespread use of a screening test (the Papanicolaou smear) and effective means of treating precancerous lesions. This is due in part to limitations in both the screening test and the treatment process. The Papanicolaou smear has low sensitivity and specificity; thus cases of dysplasia or cancer are missed and women with normal tissue undergo unnecessary evaluation and treatment procedures. Also, the evaluation and treatment process for an abnormal screening test is lengthy and requires multiple visits, making adherence problematic. For example, recent evidence has shown that the accuracy of follow-up colposcopy is highly operatordependent (90% sensitivity and 50% specificity) with highly experienced gynecologic colposcopists at a comprehensive cancer center. In contrast, the ALTS trial reported sensitivities of approximately 50% for colposcopy either immediately or as part of the standard of care, called conservative management with less experienced colposcopists [1]. Researchers are developing innovative cervical cancer screening and diagnostic technologies in order to improve current practice. One such technology is the use of fluorescence and/or reflectance spectroscopy. For example, the laser-induced fluorescence endoscopy (LIFE) device demonstrated a sensitivity of 69% and specificity of 70% to detect high-grade dysplasia in patients at high-risk for lung cancer [2], and the visually enhanced lesion scope (VELScope) achieved a sensitivity of 98% and a specificity of 100% in the detection of oral cancer in 44 dental patients [3]. Our group is testing a research version of a fluorescent macroscopic device called the multispectral digital colposcope (MDC) to be used in the detection of cervical dysplasia. In a pilot test with 29 high-grade squamous intraepithelial lesion (HGSIL) patients, the MDC achieved a sensitivity of 79% and a specificity of 88% (unpublished data under review). It images the entire field of the cervix and records a limited number of spectrally distinct fluorescence, reflectance and polarized reflectance images.
doi:10.1016/j.ygyno.2007.07.046
Patient receptivity to the MDC is unknown. We undertook a pilot study of 14 participants to compare patient pain, anxiety and satisfaction ratings of the MDC, Pap smear test, colposcopy, and biopsy. The results from these comparisons can then be used for the future refinement of the design of the MDC to heighten patient adherence to post Pap smear follow-up care. Method Fourteen colposcopy patients with a Cin Grade 2 or 3 Papanicolaou smear result were referred to the Gynecologic Oncology Clinic at the University of Texas M.D. Anderson Cancer Center (UTMDACC) or to the Harris County Hospital District Lyndon Baines Johnson Hospital Clinic in Houston Texas. Women were eligible for this pilot study if they were over the age of 18, were referred for an abnormal Papanicolaou smear result, were not pregnant, and able to communicate in English, Spanish or Chinese. UTMDACC sees primarily white, insured patients. The Harris County Hospital District Lyndon B. Johnson Hospital Clinic sees a tri-ethnic group of patients (white, African-American, and Hispanic) who are typically uninsured or with Medicaid. After obtaining informed consent, participants met with the research assistant to discuss the pilot study. Prior to their examination procedures in the colposcopy clinic, each woman was given a brief explanation of the Papanicolaou smear test, cervical biopsy, colposcopy and the MDC. Immediately afterward, women were asked to explain in their own words what the MDC procedure entailed, as well as their pre-exam opinion of the MDC, if any. The research assistant then accompanied the patient to the examination. During the examination, the research assistant assessed patient ratings immediately following each of the these procedures, which were conducted in the following order: vaginal exam, speculum insertion, lateral wall retractor insertion, first MDC, acetic acid (vinegar) contrast agent application, second MDC, colposcopy, lidocaine injection, and biopsy. Patients were asked to rate the anxiety and pain caused by the procedure. The rating for each variable was a one-item measure, i.e., 0 = not at anxious to 10 = extremely anxious. These rating scales were explained to the patient at the beginning of the appointment prior to the examination and a response card was given to the participant as the research assistant read the questions out loud. In addition, the number of their vocalizations uttered during each procedure, as well as nonverbal expressions such as flinching, were recorded during each procedure. Shortly after the examination was completed, each participant was then assessed in a separate consultation room with the behavioral interviewer, who verbally assessed the participant's perceptions of each procedure using an 11item, 3-point questionnaire. This satisfaction questionnaire assessed patients'
S84
Conference Report
Table 1 Pain and anxiety ratings during exam
# of vocalizations Pain (0–10) Anxiety (0–10)
Vaginal exam
Speculum insertion
Lateral wall retractor insertion
1st MDC
Vinegar application
Colposcopy
2nd MDC
Injection lidocaine
Biopsy
0.10 1.42 2.00
0.61 3.15 3.62
0.42 3.42 4.08
0.50 0.92 1.25
0.83 1.08 1.42
0.58 1.67 3.00
0.08 1.42 2.58
3.08 4.46 5.69
0.25 0.21 2.33
perceptions of pain, being frightened whether the doctors answered questions about the procedure to their satisfaction, whether the healthcare providers were gentle during the procedure. Mean ratings for each procedure are presented in Table 1. During the post-exam interview, participants were also asked to rate various aspects of the MDC and biopsy procedures. These results are presented in Table 2. Patients were also asked whether they liked anything about having the MDC procedure and whether they disliked anything about the procedure. Finally, participants were asked about their perceptions of positive and negative predictive value of the MDC and of biopsy on a 4-point Likert scale, ranging from very likely to probably, to maybe, to unlikely. For Spanish-speaking participants, the interviewer, who is bilingual, conducted the interviews in Spanish and used translated and validated Spanish versions of the satisfaction questionnaires.
Results During exam The results indicate that, with the exception of the application of the acetic acid contrast agent, both the first and second MDC procedures were less painful and anxiety provoking than all other procedures. The first MDC procedure, conducted before the vinegar application, was the least painful Table 2 Patient satisfaction (immediately post-exam)
1. Did the nurse/doctor explain what would be done in a way you could understand? 2. Was the nurse/doctor gentle? 3. Were you uncomfortable (reverse-coded)? a 4. Did it take too long (reverse-coded)? a 5. Did the nurse/doctor answer your questions? 6. Did the nurse/doctor seem to know what she was doing? 7. Was the procedure frightening (reverse-coded)? a 8. Did you find the instruments used for this test frightening (reverse-coded)? a There were too many people in the room (reverse-coded) a The procedure was painful (reverse-coded) a For the MDC: Was the vinegar application uncomfortable (sting, burn or cold; reverse-coded)? a For the biopsy: Did you like the lighting in the room during the test?
of all the procedures, with the exception of the biopsy, which was done under local anesthesia. The lidocaine injections received the highest pain and anxiety ratings during the exam. The anxiety rating for the first MDC procedure was the lowest of all procedures. For the second MDC, average pain and anxiety ratings increased after the vinegar application and colposcopy procedures. Post-exam The results show that overall the MDC was well tolerated by the participants. For most participants, the application of the vinegar contrast agent was the most painful aspect of the MDC procedure. The other main source of dissatisfaction with the MDC was the presence of the study personnel, such as engineers in the room. Compared with their perception of colposcopy, the average ratings for anxiety regarding the procedure and the instruments used for the procedure were lower for MDC. Similarly, the average ratings for the pain associated with the MDC were lower than that of the biopsy. Perceptions of accuracy Immediately post-exam, participants were asked to rate their perception of the positive predictive values as well as the false positive rate of the MDC and biopsy. For both procedures, participants were asked two questions. The first question asked, “If you had abnormal cells on your cervix, do you think this test will find them?” and “If you don't have abnormal cells on your cervix, do you think this test will show a normal result?” Participants were asked to rate their responses on a 0 to 4 scale, with 4 being “definitely yes”, 3 being “ probably yes”, 2 being “maybe yes” 1 being “probably no”, and 0 being “definitely no”. In general, the participants tended to rate the MDC's ability to positively detect abnormal cells as just lower than that of biopsy, 3.08 vs. 3.67. In regard to their perception of the MDC's false positive rate, participants again rated the MDC as less accurate than that of biopsy, 2.92 vs. 3.5.
Overall post-exam perception of MDC
Biopsy
2.00
1.92
1.92 1.75 1.92 2.00
1.92 1.67 1.92 1.92
1.83
2.00
1.42
1.42
1.58
1.16
1.42
1.42
Discussion
1.75 1.08
1.33
This pilot test shows that in general, the patients are highly satisfied with the MDC and seem to be more satisfied with this diagnostic procedure compared to biopsy and colposcopy. Their ratings of perceived accuracy of the MDC are slightly lower than that of biopsy, but still within the range of the perceived accuracy of biopsy. Two assessments of pain and anxiety ratings were done with the MDC, prior to the vinegar application and
1.75
a These items were reverse-coded so that the higher ratings indicated beneficial responses.
Conference Report
after. The MDC ratings tended to be higher after the vinegar application, but still not as high as that of the pain ratings associated with the lidocaine injection which is administered immediately before biopsy. The results of this pilot test indicate that it is important to separate patients' perceptions of the contrast agent application from the actual procedure of the MDC itself. Based on the favorable results comparing the MDC with colposcopy and biopsy procedures, this pilot also indicates that the MDC has the potential to engender high patient adherence to follow-up diagnostic procedures after an abnormal Pap smear result. Conflict of interest statement We declare that we have no conflict of interest.
References [1] Group TA-LTSA. A randomized trial on the management of low-grade squamous intraepithelial lesion cytology interpretations. Am J Obstet Gynecol 2003;188:1383–13892.
S85
[2] Hirsch F, Prindiville S, Miller Y, Franklin W. Fluorescence versus whitelight bronchoscopy for detection of preneoplastic lesions: a randomized study. JNCI 2001;93(18):1385. [3] Lane P, T. G., P.W., H.Z., C.P., S.N. Simple device for the direct visualization of oral-cavity tissue fluorescence. J Biomed Optic 2006; 11(2):024006.
E. Shinn* T. Le J. Gallegos K. Basen-Engquist Department of Behavioral Science, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd. Unit 193, Houston, TX 77030, USA E-mail address: [email protected]. *Corresponding author. 6 July 2007