Martin A. Weinstock, MD, PhD

Keratinocyte carcinoma (KC), or nonmelanoma skin cancer, is the most commonly diagnosed cancer in the United States.¹ Basal cell carcinoma comprises the majority of all KCs.^2,3 Squamous cell carcinoma is the second most common skin cancer, representing approximately 20% of KCs and accounting for the majority of KC-related deaths.^4-7 Malignant melanoma represents the majority of all skin cancer–related deaths.⁸ The incidence of basal cell carcinoma, squamous cell carcinoma, and malignant melanoma in the United States is on the rise and carries substantial morbidity and mortality with notable social and economic burdens.^1,8-10

Prevention is necessary to reduce skin cancer morbidity and mortality as well as rising treatment costs. The most commonly used skin cancer screening method among dermatologists is the visual full-body skin examination (FBSE), which is a noninvasive, safe, quick, and cost-effective method of early detection and prevention.¹¹ To effectively confront the growing incidence and health care burden of skin cancer, primary care providers (PCPs) must join dermatologists in conducting FBSEs.^12,13

Despite being the predominant means of secondary skin cancer prevention, the US Preventive Services Task Force (USPSTF) issued an I rating for insufficient evidence to assess the benefits vs harms of screening the adult general population by PCPs.^14,15 A major barrier to studying screening is the lack of a standardized method for conducting and reporting FBSEs.¹³ Systematic thorough skin examination generally is not performed in the primary care setting.^16-18

We aimed to investigate what occurs during an FBSE in the primary care setting and how often they are performed. We examined whether there was potential variation in the execution of the examination, what was perceived by the patient vs reported by the physician, and what was ultimately included in the medical record. Miscommunication between patient and provider regarding performance of FBSEs has previously been noted,^17-19 and we sought to characterize and quantify that miscommunication. We hypothesized that there would be lower patient-reported FBSEs compared to physicians and patient medical records. We also hypothesized that there would be variability in how physicians screened for skin cancer.

METHODS

This study was cross-sectional and was conducted based on interviews and a review of medical records at secondary- and tertiary-level units (clinics and hospitals) across the United States. We examined baseline data from a randomized controlled trial of a Web-based skin cancer early detection continuing education course—the Basic Skin Cancer Triage curriculum. Complete details have been described elsewhere.¹² This study was approved by the institutional review boards of the Providence Veterans Affairs Medical Center, Rhode Island Hospital, and Brown University (all in Providence, Rhode Island), as well as those of all recruitment sites.

Data were collected from 2005 to 2008 and included physician online surveys, patient telephone interviews, and patient medical record data abstracted by research assistants. Primary care providers included in the study were general internists, family physicians, or medicine-pediatrics practitioners who were recruited from 4 collaborating centers across the United States in the mid-Atlantic region, Ohio, Kansas, and southern California, and who had been in practice for at least a year. Patients were recruited from participating physician practices and selected by research assistants who traveled to each clinic for coordination, recruitment, and performance of medical record reviews. Patients were selected as having minimal risk of melanoma (eg, no signs of severe photodamage to the skin). Patients completed structured telephone surveys within 1 to 2 weeks of the office visit regarding the practices observed and clinical questions asked during their recent clinical encounter with their PCP.

Measures

Demographics—Demographic variables asked of physicians included age, sex, ethnicity, academic degree (MD vs DO), years in practice, training, and prior dermatology training. Demographic information asked of patients included age, sex, ethnicity, education, and household income.

 

Physician-Reported Examination and Counseling Variables—Physicians were asked to characterize their clinical practices, prompted by questions regarding performance of FBSEs: “Please think of a typical month and using the scale below, indicate how frequently you perform a total body skin exam during an annual exam (eg, periodic follow-up exam).” Physicians responded to 3 questions on a 5-point scale (1=never, 2=sometimes, 3=about half, 4=often, 5=almost always).

Patient-Reported Examination Variables—Patients also were asked to characterize the skin examination experienced in their clinical encounter with their PCP, including: “During your last visit, as far as you could tell, did your physician: (1) look at the skin on your back? (2) look at the skin on your belly area? (3) look at the skin on the back of your legs?” Patient responses were coded as yes, no, don’t know, or refused. Participants who refused were excluded from analysis; participants who responded are detailed in Table 1. In addition, patients also reported the level of undress with their physician by answering the following question: “During your last medical exam, did you: 1=keep your clothes on; 2=partially undress; 3=totally undress except for undergarments; 4=totally undress, including all undergarments?”

Patient Medical Record–Extracted Data—Research assistants used a structured abstract form to extract the information from the patient’s medical record and graded it as 0 (absence) or 1 (presence) from the medical record.

Statistical Analysis

Descriptive statistics included mean and standard deviation (SD) for continuous variables as well as frequency and percentage for categorical variables. Logit/logistic regression analysis was used to predict the odds of patient-reported outcomes that were binary with physician-reported variables as the predictor. Linear regression analysis was used to assess the association between 2 continuous variables. All analyses were conducted using SPSS version 24 (IBM).²⁰ Significance criterion was set at α of .05.

RESULTS Demographics

The final sample included data from 53 physicians and 3343 patients. The study sample mean age (SD) was 50.3 (9.9) years for PCPs (n=53) and 59.8 (16.9) years for patients (n=3343). The physician sample was 36% female and predominantly White (83%). Ninety-one percent of the PCPs had an MD (the remaining had a DO degree), and the mean (SD) years practicing was 21.8 (10.6) years. Seventeen percent of PCPs were trained in internal medicine, 4% in internal medicine and pediatrics, and 79% family medicine; 79% of PCPs had received prior training in dermatology. The patient sample was 58% female, predominantly White (84%), non-Hispanic/Latinx (95%), had completed high school (94%), and earned more than $40,000 annually (66%).

Physician- and Patient-Reported FBSEs

Physicians reported performing FBSEs with variable frequency. Among PCPs who conducted FBSEs with greater frequency, there was a modest increase in the odds that patients reported a particular body part was examined (back: odds ratio [OR], 24.5% [95% CI, 1.18-1.31; P<.001]; abdomen: OR, 23.3% [95% CI, 1.17-1.30; P<.001]; backs of legs: OR, 20.4% [95% CI, 1.13-1.28; P<.001])(Table 1). The patient-reported level of undress during examination was significantly associated with physician-reported FBSE (β=0.16 [95% CI, 0.13-0.18; P<.001])(Table 2).

Because of the bimodal distribution of scores in the physician-reported frequency of FBSEs, particularly pertaining to the extreme points of the scale, we further repeated analysis with only the never and almost always groups (Table 1). Primary care providers who reported almost always for FBSE had 29.6% increased odds of patient-reported back examination (95% CI, 1.00-1.68; P=.048) and 59.3% increased odds of patient-reported abdomen examination (95% CI, 1.23-2.06; P<.001). The raw percentages of patients who reported having their back, abdomen, and backs of legs examined when the PCP reported having never conducted an FBSE were 56%, 40%, and 26%, respectively. The raw percentages of patients who reported having their back, abdomen, and backs of legs examined when the PCP reported having almost always conducted an FBSE were 52%, 51%, and 30%, respectively. Raw percentages were calculated by dividing the number of "yes" responses by participants for each body part examined by thetotal number of participant responses (“yes” and “no”) for each respective body part. There was no significant change in odds of patient-reported backs of legs examined with PCP-reported never vs almost always conducting an FBSE. In addition, a greater patient-reported level of undress was associated with 20.2% increased odds of PCPs reporting almost always conducting an FBSE (95% CI, 1.08-1.34; P=.001).

 

 

FBSEs in Patient Medical Records

When comparing PCP-reported FBSE and report of FBSE in patient medical records, there was a 39.0% increased odds of the patient medical record indicating FBSE when physicians reported conducting an FBSE with greater frequency (95% CI, 1.30-1.48; P<.001)(eTable 1). When examining PCP-reported never vs almost always conducting an FBSE, a report of almost always was associated with 79.0% increased odds of the patient medical record indicating that an FBSE was conducted (95% CI, 1.28-2.49; P=.001). The raw percentage of the patient medical record indicating an FBSE was conducted when the PCP reported having never conducted an FBSE was 17% and 26% when the PCP reported having almost always conducted an FBSE.

When comparing the patient-reported body part examined with patient FBSE medical record documentation, an indication of yes for FBSE on the patient medical record was associated with a considerable increase in odds that patients reported a particular body part was examined (back: 91.4% [95% CI, 1.59-2.31; P<.001]; abdomen: 75.0% [95% CI, 1.45-2.11; P<.001]; backs of legs: 91.6% [95% CI, 1.56-2.36; P<.001])(eTable 2). The raw percentages of patients who reported having their back, abdomen, and backs of legs examined vs not examined when the patient medical record indicated an FBSE was completed were 24% vs 14%, 23% vs 15%, and 26% vs 16%, respectively. An increase in patient-reported level of undress was associated with a 57.0% increased odds of their medical record indicating an FBSE was conducted (95% CI, 1.45-1.70; P<.001).

COMMENT How PCPs Perform FBSEs Varies

We found that PCPs performed FBSEs with variable frequency, and among those who did, the patient report of their examination varied considerably (Table 1). There appears to be considerable ambiguity in each of these means of determining the extent to which the skin was inspected for skin cancer, which may render the task of improving such inspection more difficult. We asked patients whether their back, abdomen, and backs of legs were examined as an assessment of some of the variety of areas inspected during an FBSE. During a general well-visit appointment, a patient’s back and abdomen may be examined for multiple reasons. Patients may have misinterpreted elements of the pulmonary, cardiac, abdominal, or musculoskeletal examinations as being part of the FBSE. The back and abdomen—the least specific features of the FBSE—were reported by patients to be the most often examined. Conversely, the backs of the legs—the most specific feature of the FBSE—had the lowest odds of being examined (Table 1).

In addition to the potential limitations of patient awareness of physician activity, our results also could be explained by differences among PCPs in how they performed FBSEs. There is no standardized method of conducting an FBSE. Furthermore, not all medical students and residents are exposed to dermatology training. In our sample of 53 physicians, 79% had reported receiving dermatology training; however, we did not assess the extent to which they had been trained in conducting an FBSE and/or identifying malignant lesions. In an American survey of 659 medical students, more than two-thirds of students had never been trained or never examined a patient for skin cancer.²¹ In another American survey of 342 internal medicine, family medicine, pediatrics, and obstetrics/gynecology residents across 7 medical schools and 4 residency programs, more than three-quarters of residents had never been trained in skin cancer screening.²² Our findings reflect insufficient and inconsistent training in skin cancer screening and underscore the need for mandatory education to ensure quality FBSEs are performed in the primary care setting.

Frequency of PCPs Performing FBSEs

Similar to prior studies analyzing the frequency of FBSE performance in the primary care setting,^16,19,23,24 more than half of our PCP sample reported sometimes to never conducting FBSEs. The percentage of physicians who reported conducting FBSEs in our sample was greater than the proportion reported by the National Health Interview Survey, in which only 8% of patients received an FBSE in the prior year by a PCP or obstetrician/gynecologist,¹⁶ but similar to a smaller patient study.¹⁹ In that study, 87% of patients, regardless of their skin cancer history, also reported that they would like their PCP to perform an FBSE regularly.¹⁹ Although some of our patient participants may have declined an FBSE, it is unlikely that that would have entirely accounted for the relatively low number of PCPs who reported frequently performing FBSEs.

Documentation in Medical Records of FBSEs

Compared to PCP self-reported performance of FBSEs, considerably fewer PCPs marked the patient medical record as having completed an FBSE. Among patients with medical records that indicated an FBSE had been conducted, they reported higher odds of all 3 body parts being examined, the highest being the backs of the legs. Also, when the patient medical record indicated an FBSE had been completed, the odds that the PCP reported an FBSE also were higher. The relatively low medical record documentation of FBSEs highlights the need for more rigorous enforcement of accurate documentation. However, among the cases that were recorded, it appeared that the content of the examinations was more consistent.

Benefits of PCP-Led FBSEs

Although the USPSTF issued an I rating for PCP-led FBSEs,¹⁴ multiple national medical societies, including the American Cancer Society,²⁵ American Academy of Dermatology,²⁶ and Skin Cancer Foundation,²⁷ as well as international guidelines in Germany,²⁸ Australia,^29,30 and New Zealand,³¹ recommend regular FBSEs among the general or at-risk population; New Zealand and Australia have the highest incidence and prevalence of melanoma in the world.⁸ The benefits of physician-led FBSEs on detection of early-stage skin cancer, and in particular, melanoma detection, have been documented in numerous studies.^30,32-38 However, the variability and often poor quality of skin screening may contribute in part to the just as numerous null results from prior skin screening studies,¹⁵ perpetuating the insufficient status of skin examinations by USPSTF standards.¹⁴ Our study underscores both the variability in frequency and content of PCP-administered FBSEs. It also highlights the need for standardization of screening examinations at the medical student, trainee, and physician level.

 

 

Study Limitations

The present study has several limitations. First, there was an unknown time lag between the FBSEs and physician self-reported surveys. Similarly, there was a variable time lag between the patient examination encounter and subsequent telephone survey. Both the physician and patient survey data may have been affected by recall bias. Second, patients were not asked directly whether an FBSE had been conducted. Furthermore, patients may not have appreciated whether the body part examined was part of the FBSE or another examination. Also, screenings often were not recorded in the medical record, assuming that the patient report and/or physician report was more accurate than the medical record.

Our study also was limited by demographics; our patient sample was largely comprised of White, educated, US adults, potentially limiting the generalizability of our findings. Conversely, a notable strength of our study was that our participants were recruited from 4 geographically diverse centers. Furthermore, we had a comparatively large sample size of patients and physicians. Also, the independent assessment of provider-reported examinations, objective assessment of medical records, and patient reports of their encounters provides a strong foundation for assessing the independent contributions of each data source.

CONCLUSION

Our study highlights the challenges future studies face in promoting skin cancer screening in the primary care setting. Our findings underscore the need for a standardized FBSE as well as clear clinical expectations regarding skin cancer screening that is expected of PCPs.

As long as skin cancer screening rates remain low in the United States, patients will be subject to potential delays and missed diagnoses, impacting morbidity and mortality.⁸ There are burgeoning resources and efforts in place to increase skin cancer screening. For example, free validated online training is available for early detection of melanoma and other skin cancers (https://www.visualdx.com/skin-cancer-education/).^39-42 Future directions for bolstering screening numbers must focus on educating PCPs about skin cancer prevention and perhaps narrowing the screening population by age-appropriate risk assessments.

Keratinocyte carcinoma (KC), or nonmelanoma skin cancer, is the most commonly diagnosed cancer in the United States.¹ Basal cell carcinoma comprises the majority of all KCs.^2,3 Squamous cell carcinoma is the second most common skin cancer, representing approximately 20% of KCs and accounting for the majority of KC-related deaths.^4-7 Malignant melanoma represents the majority of all skin cancer–related deaths.⁸ The incidence of basal cell carcinoma, squamous cell carcinoma, and malignant melanoma in the United States is on the rise and carries substantial morbidity and mortality with notable social and economic burdens.^1,8-10

Prevention is necessary to reduce skin cancer morbidity and mortality as well as rising treatment costs. The most commonly used skin cancer screening method among dermatologists is the visual full-body skin examination (FBSE), which is a noninvasive, safe, quick, and cost-effective method of early detection and prevention.¹¹ To effectively confront the growing incidence and health care burden of skin cancer, primary care providers (PCPs) must join dermatologists in conducting FBSEs.^12,13

Despite being the predominant means of secondary skin cancer prevention, the US Preventive Services Task Force (USPSTF) issued an I rating for insufficient evidence to assess the benefits vs harms of screening the adult general population by PCPs.^14,15 A major barrier to studying screening is the lack of a standardized method for conducting and reporting FBSEs.¹³ Systematic thorough skin examination generally is not performed in the primary care setting.^16-18

We aimed to investigate what occurs during an FBSE in the primary care setting and how often they are performed. We examined whether there was potential variation in the execution of the examination, what was perceived by the patient vs reported by the physician, and what was ultimately included in the medical record. Miscommunication between patient and provider regarding performance of FBSEs has previously been noted,^17-19 and we sought to characterize and quantify that miscommunication. We hypothesized that there would be lower patient-reported FBSEs compared to physicians and patient medical records. We also hypothesized that there would be variability in how physicians screened for skin cancer.

METHODS

This study was cross-sectional and was conducted based on interviews and a review of medical records at secondary- and tertiary-level units (clinics and hospitals) across the United States. We examined baseline data from a randomized controlled trial of a Web-based skin cancer early detection continuing education course—the Basic Skin Cancer Triage curriculum. Complete details have been described elsewhere.¹² This study was approved by the institutional review boards of the Providence Veterans Affairs Medical Center, Rhode Island Hospital, and Brown University (all in Providence, Rhode Island), as well as those of all recruitment sites.

Data were collected from 2005 to 2008 and included physician online surveys, patient telephone interviews, and patient medical record data abstracted by research assistants. Primary care providers included in the study were general internists, family physicians, or medicine-pediatrics practitioners who were recruited from 4 collaborating centers across the United States in the mid-Atlantic region, Ohio, Kansas, and southern California, and who had been in practice for at least a year. Patients were recruited from participating physician practices and selected by research assistants who traveled to each clinic for coordination, recruitment, and performance of medical record reviews. Patients were selected as having minimal risk of melanoma (eg, no signs of severe photodamage to the skin). Patients completed structured telephone surveys within 1 to 2 weeks of the office visit regarding the practices observed and clinical questions asked during their recent clinical encounter with their PCP.

Measures

Demographics—Demographic variables asked of physicians included age, sex, ethnicity, academic degree (MD vs DO), years in practice, training, and prior dermatology training. Demographic information asked of patients included age, sex, ethnicity, education, and household income.

 

Physician-Reported Examination and Counseling Variables—Physicians were asked to characterize their clinical practices, prompted by questions regarding performance of FBSEs: “Please think of a typical month and using the scale below, indicate how frequently you perform a total body skin exam during an annual exam (eg, periodic follow-up exam).” Physicians responded to 3 questions on a 5-point scale (1=never, 2=sometimes, 3=about half, 4=often, 5=almost always).

Patient-Reported Examination Variables—Patients also were asked to characterize the skin examination experienced in their clinical encounter with their PCP, including: “During your last visit, as far as you could tell, did your physician: (1) look at the skin on your back? (2) look at the skin on your belly area? (3) look at the skin on the back of your legs?” Patient responses were coded as yes, no, don’t know, or refused. Participants who refused were excluded from analysis; participants who responded are detailed in Table 1. In addition, patients also reported the level of undress with their physician by answering the following question: “During your last medical exam, did you: 1=keep your clothes on; 2=partially undress; 3=totally undress except for undergarments; 4=totally undress, including all undergarments?”

Patient Medical Record–Extracted Data—Research assistants used a structured abstract form to extract the information from the patient’s medical record and graded it as 0 (absence) or 1 (presence) from the medical record.

Statistical Analysis

Descriptive statistics included mean and standard deviation (SD) for continuous variables as well as frequency and percentage for categorical variables. Logit/logistic regression analysis was used to predict the odds of patient-reported outcomes that were binary with physician-reported variables as the predictor. Linear regression analysis was used to assess the association between 2 continuous variables. All analyses were conducted using SPSS version 24 (IBM).²⁰ Significance criterion was set at α of .05.

RESULTS Demographics

The final sample included data from 53 physicians and 3343 patients. The study sample mean age (SD) was 50.3 (9.9) years for PCPs (n=53) and 59.8 (16.9) years for patients (n=3343). The physician sample was 36% female and predominantly White (83%). Ninety-one percent of the PCPs had an MD (the remaining had a DO degree), and the mean (SD) years practicing was 21.8 (10.6) years. Seventeen percent of PCPs were trained in internal medicine, 4% in internal medicine and pediatrics, and 79% family medicine; 79% of PCPs had received prior training in dermatology. The patient sample was 58% female, predominantly White (84%), non-Hispanic/Latinx (95%), had completed high school (94%), and earned more than $40,000 annually (66%).

Physician- and Patient-Reported FBSEs

Physicians reported performing FBSEs with variable frequency. Among PCPs who conducted FBSEs with greater frequency, there was a modest increase in the odds that patients reported a particular body part was examined (back: odds ratio [OR], 24.5% [95% CI, 1.18-1.31; P<.001]; abdomen: OR, 23.3% [95% CI, 1.17-1.30; P<.001]; backs of legs: OR, 20.4% [95% CI, 1.13-1.28; P<.001])(Table 1). The patient-reported level of undress during examination was significantly associated with physician-reported FBSE (β=0.16 [95% CI, 0.13-0.18; P<.001])(Table 2).

Because of the bimodal distribution of scores in the physician-reported frequency of FBSEs, particularly pertaining to the extreme points of the scale, we further repeated analysis with only the never and almost always groups (Table 1). Primary care providers who reported almost always for FBSE had 29.6% increased odds of patient-reported back examination (95% CI, 1.00-1.68; P=.048) and 59.3% increased odds of patient-reported abdomen examination (95% CI, 1.23-2.06; P<.001). The raw percentages of patients who reported having their back, abdomen, and backs of legs examined when the PCP reported having never conducted an FBSE were 56%, 40%, and 26%, respectively. The raw percentages of patients who reported having their back, abdomen, and backs of legs examined when the PCP reported having almost always conducted an FBSE were 52%, 51%, and 30%, respectively. Raw percentages were calculated by dividing the number of "yes" responses by participants for each body part examined by thetotal number of participant responses (“yes” and “no”) for each respective body part. There was no significant change in odds of patient-reported backs of legs examined with PCP-reported never vs almost always conducting an FBSE. In addition, a greater patient-reported level of undress was associated with 20.2% increased odds of PCPs reporting almost always conducting an FBSE (95% CI, 1.08-1.34; P=.001).

 

 

FBSEs in Patient Medical Records

When comparing PCP-reported FBSE and report of FBSE in patient medical records, there was a 39.0% increased odds of the patient medical record indicating FBSE when physicians reported conducting an FBSE with greater frequency (95% CI, 1.30-1.48; P<.001)(eTable 1). When examining PCP-reported never vs almost always conducting an FBSE, a report of almost always was associated with 79.0% increased odds of the patient medical record indicating that an FBSE was conducted (95% CI, 1.28-2.49; P=.001). The raw percentage of the patient medical record indicating an FBSE was conducted when the PCP reported having never conducted an FBSE was 17% and 26% when the PCP reported having almost always conducted an FBSE.

When comparing the patient-reported body part examined with patient FBSE medical record documentation, an indication of yes for FBSE on the patient medical record was associated with a considerable increase in odds that patients reported a particular body part was examined (back: 91.4% [95% CI, 1.59-2.31; P<.001]; abdomen: 75.0% [95% CI, 1.45-2.11; P<.001]; backs of legs: 91.6% [95% CI, 1.56-2.36; P<.001])(eTable 2). The raw percentages of patients who reported having their back, abdomen, and backs of legs examined vs not examined when the patient medical record indicated an FBSE was completed were 24% vs 14%, 23% vs 15%, and 26% vs 16%, respectively. An increase in patient-reported level of undress was associated with a 57.0% increased odds of their medical record indicating an FBSE was conducted (95% CI, 1.45-1.70; P<.001).

COMMENT How PCPs Perform FBSEs Varies

We found that PCPs performed FBSEs with variable frequency, and among those who did, the patient report of their examination varied considerably (Table 1). There appears to be considerable ambiguity in each of these means of determining the extent to which the skin was inspected for skin cancer, which may render the task of improving such inspection more difficult. We asked patients whether their back, abdomen, and backs of legs were examined as an assessment of some of the variety of areas inspected during an FBSE. During a general well-visit appointment, a patient’s back and abdomen may be examined for multiple reasons. Patients may have misinterpreted elements of the pulmonary, cardiac, abdominal, or musculoskeletal examinations as being part of the FBSE. The back and abdomen—the least specific features of the FBSE—were reported by patients to be the most often examined. Conversely, the backs of the legs—the most specific feature of the FBSE—had the lowest odds of being examined (Table 1).

In addition to the potential limitations of patient awareness of physician activity, our results also could be explained by differences among PCPs in how they performed FBSEs. There is no standardized method of conducting an FBSE. Furthermore, not all medical students and residents are exposed to dermatology training. In our sample of 53 physicians, 79% had reported receiving dermatology training; however, we did not assess the extent to which they had been trained in conducting an FBSE and/or identifying malignant lesions. In an American survey of 659 medical students, more than two-thirds of students had never been trained or never examined a patient for skin cancer.²¹ In another American survey of 342 internal medicine, family medicine, pediatrics, and obstetrics/gynecology residents across 7 medical schools and 4 residency programs, more than three-quarters of residents had never been trained in skin cancer screening.²² Our findings reflect insufficient and inconsistent training in skin cancer screening and underscore the need for mandatory education to ensure quality FBSEs are performed in the primary care setting.

Frequency of PCPs Performing FBSEs

Similar to prior studies analyzing the frequency of FBSE performance in the primary care setting,^16,19,23,24 more than half of our PCP sample reported sometimes to never conducting FBSEs. The percentage of physicians who reported conducting FBSEs in our sample was greater than the proportion reported by the National Health Interview Survey, in which only 8% of patients received an FBSE in the prior year by a PCP or obstetrician/gynecologist,¹⁶ but similar to a smaller patient study.¹⁹ In that study, 87% of patients, regardless of their skin cancer history, also reported that they would like their PCP to perform an FBSE regularly.¹⁹ Although some of our patient participants may have declined an FBSE, it is unlikely that that would have entirely accounted for the relatively low number of PCPs who reported frequently performing FBSEs.

Documentation in Medical Records of FBSEs

Compared to PCP self-reported performance of FBSEs, considerably fewer PCPs marked the patient medical record as having completed an FBSE. Among patients with medical records that indicated an FBSE had been conducted, they reported higher odds of all 3 body parts being examined, the highest being the backs of the legs. Also, when the patient medical record indicated an FBSE had been completed, the odds that the PCP reported an FBSE also were higher. The relatively low medical record documentation of FBSEs highlights the need for more rigorous enforcement of accurate documentation. However, among the cases that were recorded, it appeared that the content of the examinations was more consistent.

Benefits of PCP-Led FBSEs

Although the USPSTF issued an I rating for PCP-led FBSEs,¹⁴ multiple national medical societies, including the American Cancer Society,²⁵ American Academy of Dermatology,²⁶ and Skin Cancer Foundation,²⁷ as well as international guidelines in Germany,²⁸ Australia,^29,30 and New Zealand,³¹ recommend regular FBSEs among the general or at-risk population; New Zealand and Australia have the highest incidence and prevalence of melanoma in the world.⁸ The benefits of physician-led FBSEs on detection of early-stage skin cancer, and in particular, melanoma detection, have been documented in numerous studies.^30,32-38 However, the variability and often poor quality of skin screening may contribute in part to the just as numerous null results from prior skin screening studies,¹⁵ perpetuating the insufficient status of skin examinations by USPSTF standards.¹⁴ Our study underscores both the variability in frequency and content of PCP-administered FBSEs. It also highlights the need for standardization of screening examinations at the medical student, trainee, and physician level.

 

 

Study Limitations

The present study has several limitations. First, there was an unknown time lag between the FBSEs and physician self-reported surveys. Similarly, there was a variable time lag between the patient examination encounter and subsequent telephone survey. Both the physician and patient survey data may have been affected by recall bias. Second, patients were not asked directly whether an FBSE had been conducted. Furthermore, patients may not have appreciated whether the body part examined was part of the FBSE or another examination. Also, screenings often were not recorded in the medical record, assuming that the patient report and/or physician report was more accurate than the medical record.

Our study also was limited by demographics; our patient sample was largely comprised of White, educated, US adults, potentially limiting the generalizability of our findings. Conversely, a notable strength of our study was that our participants were recruited from 4 geographically diverse centers. Furthermore, we had a comparatively large sample size of patients and physicians. Also, the independent assessment of provider-reported examinations, objective assessment of medical records, and patient reports of their encounters provides a strong foundation for assessing the independent contributions of each data source.

CONCLUSION

Our study highlights the challenges future studies face in promoting skin cancer screening in the primary care setting. Our findings underscore the need for a standardized FBSE as well as clear clinical expectations regarding skin cancer screening that is expected of PCPs.

As long as skin cancer screening rates remain low in the United States, patients will be subject to potential delays and missed diagnoses, impacting morbidity and mortality.⁸ There are burgeoning resources and efforts in place to increase skin cancer screening. For example, free validated online training is available for early detection of melanoma and other skin cancers (https://www.visualdx.com/skin-cancer-education/).^39-42 Future directions for bolstering screening numbers must focus on educating PCPs about skin cancer prevention and perhaps narrowing the screening population by age-appropriate risk assessments.

Keratinocyte carcinoma (KC), or nonmelanoma skin cancer, is the most commonly diagnosed cancer in the United States.¹ Basal cell carcinoma comprises the majority of all KCs.^2,3 Squamous cell carcinoma is the second most common skin cancer, representing approximately 20% of KCs and accounting for the majority of KC-related deaths.^4-7 Malignant melanoma represents the majority of all skin cancer–related deaths.⁸ The incidence of basal cell carcinoma, squamous cell carcinoma, and malignant melanoma in the United States is on the rise and carries substantial morbidity and mortality with notable social and economic burdens.^1,8-10

Prevention is necessary to reduce skin cancer morbidity and mortality as well as rising treatment costs. The most commonly used skin cancer screening method among dermatologists is the visual full-body skin examination (FBSE), which is a noninvasive, safe, quick, and cost-effective method of early detection and prevention.¹¹ To effectively confront the growing incidence and health care burden of skin cancer, primary care providers (PCPs) must join dermatologists in conducting FBSEs.^12,13

Despite being the predominant means of secondary skin cancer prevention, the US Preventive Services Task Force (USPSTF) issued an I rating for insufficient evidence to assess the benefits vs harms of screening the adult general population by PCPs.^14,15 A major barrier to studying screening is the lack of a standardized method for conducting and reporting FBSEs.¹³ Systematic thorough skin examination generally is not performed in the primary care setting.^16-18

We aimed to investigate what occurs during an FBSE in the primary care setting and how often they are performed. We examined whether there was potential variation in the execution of the examination, what was perceived by the patient vs reported by the physician, and what was ultimately included in the medical record. Miscommunication between patient and provider regarding performance of FBSEs has previously been noted,^17-19 and we sought to characterize and quantify that miscommunication. We hypothesized that there would be lower patient-reported FBSEs compared to physicians and patient medical records. We also hypothesized that there would be variability in how physicians screened for skin cancer.

METHODS

This study was cross-sectional and was conducted based on interviews and a review of medical records at secondary- and tertiary-level units (clinics and hospitals) across the United States. We examined baseline data from a randomized controlled trial of a Web-based skin cancer early detection continuing education course—the Basic Skin Cancer Triage curriculum. Complete details have been described elsewhere.¹² This study was approved by the institutional review boards of the Providence Veterans Affairs Medical Center, Rhode Island Hospital, and Brown University (all in Providence, Rhode Island), as well as those of all recruitment sites.

Data were collected from 2005 to 2008 and included physician online surveys, patient telephone interviews, and patient medical record data abstracted by research assistants. Primary care providers included in the study were general internists, family physicians, or medicine-pediatrics practitioners who were recruited from 4 collaborating centers across the United States in the mid-Atlantic region, Ohio, Kansas, and southern California, and who had been in practice for at least a year. Patients were recruited from participating physician practices and selected by research assistants who traveled to each clinic for coordination, recruitment, and performance of medical record reviews. Patients were selected as having minimal risk of melanoma (eg, no signs of severe photodamage to the skin). Patients completed structured telephone surveys within 1 to 2 weeks of the office visit regarding the practices observed and clinical questions asked during their recent clinical encounter with their PCP.

Measures

Demographics—Demographic variables asked of physicians included age, sex, ethnicity, academic degree (MD vs DO), years in practice, training, and prior dermatology training. Demographic information asked of patients included age, sex, ethnicity, education, and household income.

 

Physician-Reported Examination and Counseling Variables—Physicians were asked to characterize their clinical practices, prompted by questions regarding performance of FBSEs: “Please think of a typical month and using the scale below, indicate how frequently you perform a total body skin exam during an annual exam (eg, periodic follow-up exam).” Physicians responded to 3 questions on a 5-point scale (1=never, 2=sometimes, 3=about half, 4=often, 5=almost always).

Patient-Reported Examination Variables—Patients also were asked to characterize the skin examination experienced in their clinical encounter with their PCP, including: “During your last visit, as far as you could tell, did your physician: (1) look at the skin on your back? (2) look at the skin on your belly area? (3) look at the skin on the back of your legs?” Patient responses were coded as yes, no, don’t know, or refused. Participants who refused were excluded from analysis; participants who responded are detailed in Table 1. In addition, patients also reported the level of undress with their physician by answering the following question: “During your last medical exam, did you: 1=keep your clothes on; 2=partially undress; 3=totally undress except for undergarments; 4=totally undress, including all undergarments?”

Patient Medical Record–Extracted Data—Research assistants used a structured abstract form to extract the information from the patient’s medical record and graded it as 0 (absence) or 1 (presence) from the medical record.

Statistical Analysis

Descriptive statistics included mean and standard deviation (SD) for continuous variables as well as frequency and percentage for categorical variables. Logit/logistic regression analysis was used to predict the odds of patient-reported outcomes that were binary with physician-reported variables as the predictor. Linear regression analysis was used to assess the association between 2 continuous variables. All analyses were conducted using SPSS version 24 (IBM).²⁰ Significance criterion was set at α of .05.

RESULTS Demographics

The final sample included data from 53 physicians and 3343 patients. The study sample mean age (SD) was 50.3 (9.9) years for PCPs (n=53) and 59.8 (16.9) years for patients (n=3343). The physician sample was 36% female and predominantly White (83%). Ninety-one percent of the PCPs had an MD (the remaining had a DO degree), and the mean (SD) years practicing was 21.8 (10.6) years. Seventeen percent of PCPs were trained in internal medicine, 4% in internal medicine and pediatrics, and 79% family medicine; 79% of PCPs had received prior training in dermatology. The patient sample was 58% female, predominantly White (84%), non-Hispanic/Latinx (95%), had completed high school (94%), and earned more than $40,000 annually (66%).

Physician- and Patient-Reported FBSEs

Physicians reported performing FBSEs with variable frequency. Among PCPs who conducted FBSEs with greater frequency, there was a modest increase in the odds that patients reported a particular body part was examined (back: odds ratio [OR], 24.5% [95% CI, 1.18-1.31; P<.001]; abdomen: OR, 23.3% [95% CI, 1.17-1.30; P<.001]; backs of legs: OR, 20.4% [95% CI, 1.13-1.28; P<.001])(Table 1). The patient-reported level of undress during examination was significantly associated with physician-reported FBSE (β=0.16 [95% CI, 0.13-0.18; P<.001])(Table 2).

Because of the bimodal distribution of scores in the physician-reported frequency of FBSEs, particularly pertaining to the extreme points of the scale, we further repeated analysis with only the never and almost always groups (Table 1). Primary care providers who reported almost always for FBSE had 29.6% increased odds of patient-reported back examination (95% CI, 1.00-1.68; P=.048) and 59.3% increased odds of patient-reported abdomen examination (95% CI, 1.23-2.06; P<.001). The raw percentages of patients who reported having their back, abdomen, and backs of legs examined when the PCP reported having never conducted an FBSE were 56%, 40%, and 26%, respectively. The raw percentages of patients who reported having their back, abdomen, and backs of legs examined when the PCP reported having almost always conducted an FBSE were 52%, 51%, and 30%, respectively. Raw percentages were calculated by dividing the number of "yes" responses by participants for each body part examined by thetotal number of participant responses (“yes” and “no”) for each respective body part. There was no significant change in odds of patient-reported backs of legs examined with PCP-reported never vs almost always conducting an FBSE. In addition, a greater patient-reported level of undress was associated with 20.2% increased odds of PCPs reporting almost always conducting an FBSE (95% CI, 1.08-1.34; P=.001).

 

 

FBSEs in Patient Medical Records

When comparing PCP-reported FBSE and report of FBSE in patient medical records, there was a 39.0% increased odds of the patient medical record indicating FBSE when physicians reported conducting an FBSE with greater frequency (95% CI, 1.30-1.48; P<.001)(eTable 1). When examining PCP-reported never vs almost always conducting an FBSE, a report of almost always was associated with 79.0% increased odds of the patient medical record indicating that an FBSE was conducted (95% CI, 1.28-2.49; P=.001). The raw percentage of the patient medical record indicating an FBSE was conducted when the PCP reported having never conducted an FBSE was 17% and 26% when the PCP reported having almost always conducted an FBSE.

When comparing the patient-reported body part examined with patient FBSE medical record documentation, an indication of yes for FBSE on the patient medical record was associated with a considerable increase in odds that patients reported a particular body part was examined (back: 91.4% [95% CI, 1.59-2.31; P<.001]; abdomen: 75.0% [95% CI, 1.45-2.11; P<.001]; backs of legs: 91.6% [95% CI, 1.56-2.36; P<.001])(eTable 2). The raw percentages of patients who reported having their back, abdomen, and backs of legs examined vs not examined when the patient medical record indicated an FBSE was completed were 24% vs 14%, 23% vs 15%, and 26% vs 16%, respectively. An increase in patient-reported level of undress was associated with a 57.0% increased odds of their medical record indicating an FBSE was conducted (95% CI, 1.45-1.70; P<.001).

COMMENT How PCPs Perform FBSEs Varies

We found that PCPs performed FBSEs with variable frequency, and among those who did, the patient report of their examination varied considerably (Table 1). There appears to be considerable ambiguity in each of these means of determining the extent to which the skin was inspected for skin cancer, which may render the task of improving such inspection more difficult. We asked patients whether their back, abdomen, and backs of legs were examined as an assessment of some of the variety of areas inspected during an FBSE. During a general well-visit appointment, a patient’s back and abdomen may be examined for multiple reasons. Patients may have misinterpreted elements of the pulmonary, cardiac, abdominal, or musculoskeletal examinations as being part of the FBSE. The back and abdomen—the least specific features of the FBSE—were reported by patients to be the most often examined. Conversely, the backs of the legs—the most specific feature of the FBSE—had the lowest odds of being examined (Table 1).

In addition to the potential limitations of patient awareness of physician activity, our results also could be explained by differences among PCPs in how they performed FBSEs. There is no standardized method of conducting an FBSE. Furthermore, not all medical students and residents are exposed to dermatology training. In our sample of 53 physicians, 79% had reported receiving dermatology training; however, we did not assess the extent to which they had been trained in conducting an FBSE and/or identifying malignant lesions. In an American survey of 659 medical students, more than two-thirds of students had never been trained or never examined a patient for skin cancer.²¹ In another American survey of 342 internal medicine, family medicine, pediatrics, and obstetrics/gynecology residents across 7 medical schools and 4 residency programs, more than three-quarters of residents had never been trained in skin cancer screening.²² Our findings reflect insufficient and inconsistent training in skin cancer screening and underscore the need for mandatory education to ensure quality FBSEs are performed in the primary care setting.

Frequency of PCPs Performing FBSEs

Similar to prior studies analyzing the frequency of FBSE performance in the primary care setting,^16,19,23,24 more than half of our PCP sample reported sometimes to never conducting FBSEs. The percentage of physicians who reported conducting FBSEs in our sample was greater than the proportion reported by the National Health Interview Survey, in which only 8% of patients received an FBSE in the prior year by a PCP or obstetrician/gynecologist,¹⁶ but similar to a smaller patient study.¹⁹ In that study, 87% of patients, regardless of their skin cancer history, also reported that they would like their PCP to perform an FBSE regularly.¹⁹ Although some of our patient participants may have declined an FBSE, it is unlikely that that would have entirely accounted for the relatively low number of PCPs who reported frequently performing FBSEs.

Documentation in Medical Records of FBSEs

Compared to PCP self-reported performance of FBSEs, considerably fewer PCPs marked the patient medical record as having completed an FBSE. Among patients with medical records that indicated an FBSE had been conducted, they reported higher odds of all 3 body parts being examined, the highest being the backs of the legs. Also, when the patient medical record indicated an FBSE had been completed, the odds that the PCP reported an FBSE also were higher. The relatively low medical record documentation of FBSEs highlights the need for more rigorous enforcement of accurate documentation. However, among the cases that were recorded, it appeared that the content of the examinations was more consistent.

Benefits of PCP-Led FBSEs

Although the USPSTF issued an I rating for PCP-led FBSEs,¹⁴ multiple national medical societies, including the American Cancer Society,²⁵ American Academy of Dermatology,²⁶ and Skin Cancer Foundation,²⁷ as well as international guidelines in Germany,²⁸ Australia,^29,30 and New Zealand,³¹ recommend regular FBSEs among the general or at-risk population; New Zealand and Australia have the highest incidence and prevalence of melanoma in the world.⁸ The benefits of physician-led FBSEs on detection of early-stage skin cancer, and in particular, melanoma detection, have been documented in numerous studies.^30,32-38 However, the variability and often poor quality of skin screening may contribute in part to the just as numerous null results from prior skin screening studies,¹⁵ perpetuating the insufficient status of skin examinations by USPSTF standards.¹⁴ Our study underscores both the variability in frequency and content of PCP-administered FBSEs. It also highlights the need for standardization of screening examinations at the medical student, trainee, and physician level.

 

 

Study Limitations

The present study has several limitations. First, there was an unknown time lag between the FBSEs and physician self-reported surveys. Similarly, there was a variable time lag between the patient examination encounter and subsequent telephone survey. Both the physician and patient survey data may have been affected by recall bias. Second, patients were not asked directly whether an FBSE had been conducted. Furthermore, patients may not have appreciated whether the body part examined was part of the FBSE or another examination. Also, screenings often were not recorded in the medical record, assuming that the patient report and/or physician report was more accurate than the medical record.

Our study also was limited by demographics; our patient sample was largely comprised of White, educated, US adults, potentially limiting the generalizability of our findings. Conversely, a notable strength of our study was that our participants were recruited from 4 geographically diverse centers. Furthermore, we had a comparatively large sample size of patients and physicians. Also, the independent assessment of provider-reported examinations, objective assessment of medical records, and patient reports of their encounters provides a strong foundation for assessing the independent contributions of each data source.

CONCLUSION

Our study highlights the challenges future studies face in promoting skin cancer screening in the primary care setting. Our findings underscore the need for a standardized FBSE as well as clear clinical expectations regarding skin cancer screening that is expected of PCPs.

As long as skin cancer screening rates remain low in the United States, patients will be subject to potential delays and missed diagnoses, impacting morbidity and mortality.⁸ There are burgeoning resources and efforts in place to increase skin cancer screening. For example, free validated online training is available for early detection of melanoma and other skin cancers (https://www.visualdx.com/skin-cancer-education/).^39-42 Future directions for bolstering screening numbers must focus on educating PCPs about skin cancer prevention and perhaps narrowing the screening population by age-appropriate risk assessments.

Squamous cell carcinoma (SCC) has an estimated incidence of more than 2.5 million cases per year in the United States.¹ Its precursor lesion, actinic keratosis (AK), had an estimated prevalence of 39.5 million cases in the United States in 2004.² The dermatology clinic at the Providence VA Medical Center in Rhode Island exerts consistent efforts to treat both SCC and AK by prescribing topical 5-fluorouracil (5-FU) and lifestyle changes that include avoiding sun exposure, wearing protective clothing, and using effective sunscreen.³ A single course of topical 5-FU in veterans has been shown to decrease the risk for SCC by 74% during the year after treatment and also improve AK clearance rates.^4,5

Effectiveness of 5-FU for secondary prevention can be decreased by patient misunderstandings, such as applying 5-FU for too short a time or using the corticosteroid cream prematurely, as well as patient nonadherence due to expected adverse skin reactions to 5-FU.⁶ Education and reassurance before and during therapy maximize patient compliance but can be difficult to accomplish in clinics when time is in short supply. During standard 5-FU treatment at the Providence VA Medical Center, the provider prescribes 5-FU and posttherapy corticosteroid cream at a clinic visit after an informed consent process that includes reviewing with the patient a color handout depicting the expected adverse skin reaction. Patients who later experience severe inflammation and anxiety call the clinic and are overbooked as needed.

To address the practical obstacles to the patient experience with topical 5-FU therapy, we developed a group chemoprevention clinic based on the shared medical appointment (SMA) model. Shared medical appointments, during which multiple patients are scheduled at the same visit with 1 or more health care providers, promote patient risk reduction and guideline adherence in complex diseases, such as chronic heart failure and diabetes mellitus, through efficient resource use, improvement of access to care, and promotion of behavioral changes through group support.^7-13 To increase efficiency in the group chemoprevention clinic, we integrated dermatology nurses and nurse practitioners from the chronic care model into the group medical visits, which ran from September 2016 through March 2017. Because veterans could interact with peers undergoing the same treatment, we hypothesized that use of the cream in a group setting would provide positive reinforcement during the course of therapy, resulting in a positive treatment experience. We conducted a retrospective review of medical records of the patients involved in this pilot study to evaluate this model.

Methods

Institutional review board approval was obtained from the Providence VA Medical Center. Informed consent was waived because this study was a retrospective review of medical records.

Study Population
We offered participation in a group chemoprevention clinic based on the SMA model for patients of the dermatology clinic at the Providence VA Medical Center who were planning to start 5-FU in the fall of 2016. Patients were asked if they were interested in participating in a group clinic to receive their 5-FU treatment. Patients who were established dermatology patients within the Veterans Affairs system and had scheduled annual full-body skin examinations were included; patients were not excluded if they had a prior diagnosis of AK but had not been previously treated with 5-FU.

Design
Each SMA group consisted of 3 to 4 patients who met initially to receive the 5-FU medication and attend a 10-minute live presentation that included information on the dangers and causes of SCC and AK, treatment options, directions for using 5-FU, expected spectrum of side effects, and how to minimize the discomfort of treatment side effects. Patients had field treatment limited to areas with clinically apparent AKs on the face and ears. They were prescribed 5-FU cream 5% twice daily.

One physician, one nurse practitioner, and one registered nurse were present at each 1-hour clinic. Patients arrived and were checked in individually by the providers. At check-in, the provider handed the patient a printout of his/her current medication list and a pen to make any necessary corrections. This list was reviewed privately with the patient so the provider could reconcile the medication list and review the patient’s medical history and so the patient could provide informed consent. After, the patient had the opportunity to select a seat from chairs arranged in a circle. There was a live PowerPoint presentation given at the beginning of the clinic with a question-and-answer session immediately following that contained information about the disease and medication process. Clinicians assisted the patients with the initial application of 5-FU in the large group room, and each patient received a handout with information about AKs and a 40-g tube of the 5-FU cream.

 

This same group then met again 2 weeks later, at which time most patients were experiencing expected adverse skin reactions. At that time, there was a 10-minute live presentation that congratulated the patients on their success in the treatment process, reviewed what to expect in the following weeks, and reinforced the importance of future sun-protective practices. At each visit, photographs and feedback about the group setting were obtained in the large group room. After photographing and rating each patient’s skin reaction severity, the clinicians advised each patient either to continue the 5-FU medication for another week or to discontinue it and apply the triamcinolone cream 0.1% up to 4 times daily as needed for up to 7 days. Each patient received the prescription corticosteroid cream and a gift, courtesy of the VA Voluntary Service Program, of a 360-degree brimmed hat and sunscreen. Time for questions or concerns was available at both sessions.

Data Collection
We reviewed medical records via the Computerized Patient Record System, a nationally accessible electronic health record system, for all patients who participated in the SMA visits from September 2016 through March 2017. Any patient who attended the initial visit but declined therapy at that time was excluded.

Outcomes included attendance at both appointments, stated completion of 14 days of 5-FU treatment, and evidence of 5-FU use according to a validated numeric scale of skin reaction severity.¹⁴ We recorded telephone calls and other dermatology clinic and teledermatology appointments during the 3 weeks after the first appointment and the number of dermatology clinic appointments 6 months before and after the SMA for side effects related to 5-FU treatment. Feedback about treatment in the group setting was obtained at both visits.

Results

A total of 16 male patients attended the SMAs, and 14 attended both sessions. Of the 2 patients who were excluded from the study, 1 declined to be scheduled for the second group appointment, and the other was scheduled and confirmed but did not come for his appointment. The mean age was 72 years.

Of the 14 study patients who attended both sessions of the group clinic, 10 stated that they completed 2 weeks of 5-FU therapy, and the other 4 stated that they completed at least 11 days. Results of the validated scale used by clinicians during the second visit to grade the patients’ 5-FU reactions showed that all 14 patients demonstrated at least some expected adverse reactions (eTable). Eleven of 14 patients showed crusting and erosion; 13 showed grade 2 or higher erythema severity. One patient who stopped treatment after 11 days telephoned the dermatology clinic within 1 week of his second SMA. Another patient who stopped treatment after 11 days had a separate dermatology surgery clinic appointment within the 3-week period after starting 5-FU for a recent basal cell carcinoma excision. None of the 14 patients had a dermatology appointment scheduled within 6 months before or after for a 5-FU adverse reaction. One patient who completed the 14-day course was referred to teledermatology for insect bites within that period.

None of the patients were prophylaxed for herpes simplex virus during the treatment period, and none developed a herpes simplex virus eruption during this study. None of the patients required antibiotics for secondary impetiginization of the treatment site.

The verbal feedback about the group setting from patients who completed both appointments was uniformly positive, with specific appreciation for the normalization of the treatment process and opportunity to ask questions with their peers. At the conclusion of the second appointment, all of the patients reported an increased understanding of their condition and the importance of future sun-protective behaviors.

 

Comment

Shared medical appointments promote treatment adherence in patients with chronic heart failure and diabetes mellitus through efficient resource use, improvement of access to care, and promotion of behavioral change through group support.^7-13 Within the dermatology literature, SMAs are more profitable than regular clinic appointments.¹⁵ In SMAs designed to improve patient education for preoperative consultations for Mohs micrographic surgery, patient satisfaction reported in postvisit surveys was high, with 84.7% of 149 patients reporting they found the session useful, highlighting how SMAs have potential as practical alternatives to regular medical appointments.¹⁶ Similarly, the feedback about the group setting from our patients who completed both appointments was uniformly positive, with specific appreciation for the normalization of the treatment process and opportunity to ask questions with their peers.

The group setting—where patients were interacting with peers undergoing the same treatment—provided an encouraging environment during the course of 5-FU therapy, resulting in a positive treatment experience. Additionally, at the conclusion of the second visit, patients reported an increased understanding of their condition and the importance of future sun-protective behaviors, further demonstrating the impact of this pilot initiative.

The Veterans Affairs’ Current Procedural Terminology code for a group clinic is 99078. Veterans Affairs medical centers and private practices have different approaches to billing and compensation. As more accountable care organizations are formed, there may be a different mixture of ways for handling these SMAs.

Limitations
Our study is limited by the small sample size, selection bias, and self-reported measure of adherence. Adherence to 5-FU is excellent without group support, and without a control group, it is unclear how beneficial the group setting was for adherence.¹⁷ The presence of the expected skin reactions at the 2-week return visit cannot account for adherence during the interval between the visits, and this close follow-up may be responsible for the high adherence in this group setting. The major side effects with 5-FU are short-term. Nonetheless, longer-term follow-up would be helpful and a worthy future endeavor.

Veterans share a common bond of military service that may not be shared in a typical private practice setting, which may have facilitated success of this pilot study. We recommend group clinics be evaluated independently in private practices and other systems. However, despite these limitations, the patients in the SMAs demonstrated positive reactions to 5-FU therapy, suggesting the potential for utilizing group clinics as a practical alternative to regular medical appointments.

Conclusion

Our pilot group clinics for AK treatment and chemoprevention of SCC with 5-FU suggest that this model is well received. The group format, which demonstrated uniformly positive reactions to 5-FU therapy, shows promise in battling an epidemic of skin cancer that demands cost-effective interventions.

Squamous cell carcinoma (SCC) has an estimated incidence of more than 2.5 million cases per year in the United States.¹ Its precursor lesion, actinic keratosis (AK), had an estimated prevalence of 39.5 million cases in the United States in 2004.² The dermatology clinic at the Providence VA Medical Center in Rhode Island exerts consistent efforts to treat both SCC and AK by prescribing topical 5-fluorouracil (5-FU) and lifestyle changes that include avoiding sun exposure, wearing protective clothing, and using effective sunscreen.³ A single course of topical 5-FU in veterans has been shown to decrease the risk for SCC by 74% during the year after treatment and also improve AK clearance rates.^4,5

Effectiveness of 5-FU for secondary prevention can be decreased by patient misunderstandings, such as applying 5-FU for too short a time or using the corticosteroid cream prematurely, as well as patient nonadherence due to expected adverse skin reactions to 5-FU.⁶ Education and reassurance before and during therapy maximize patient compliance but can be difficult to accomplish in clinics when time is in short supply. During standard 5-FU treatment at the Providence VA Medical Center, the provider prescribes 5-FU and posttherapy corticosteroid cream at a clinic visit after an informed consent process that includes reviewing with the patient a color handout depicting the expected adverse skin reaction. Patients who later experience severe inflammation and anxiety call the clinic and are overbooked as needed.

To address the practical obstacles to the patient experience with topical 5-FU therapy, we developed a group chemoprevention clinic based on the shared medical appointment (SMA) model. Shared medical appointments, during which multiple patients are scheduled at the same visit with 1 or more health care providers, promote patient risk reduction and guideline adherence in complex diseases, such as chronic heart failure and diabetes mellitus, through efficient resource use, improvement of access to care, and promotion of behavioral changes through group support.^7-13 To increase efficiency in the group chemoprevention clinic, we integrated dermatology nurses and nurse practitioners from the chronic care model into the group medical visits, which ran from September 2016 through March 2017. Because veterans could interact with peers undergoing the same treatment, we hypothesized that use of the cream in a group setting would provide positive reinforcement during the course of therapy, resulting in a positive treatment experience. We conducted a retrospective review of medical records of the patients involved in this pilot study to evaluate this model.

Methods

Institutional review board approval was obtained from the Providence VA Medical Center. Informed consent was waived because this study was a retrospective review of medical records.

Study Population
We offered participation in a group chemoprevention clinic based on the SMA model for patients of the dermatology clinic at the Providence VA Medical Center who were planning to start 5-FU in the fall of 2016. Patients were asked if they were interested in participating in a group clinic to receive their 5-FU treatment. Patients who were established dermatology patients within the Veterans Affairs system and had scheduled annual full-body skin examinations were included; patients were not excluded if they had a prior diagnosis of AK but had not been previously treated with 5-FU.

Design
Each SMA group consisted of 3 to 4 patients who met initially to receive the 5-FU medication and attend a 10-minute live presentation that included information on the dangers and causes of SCC and AK, treatment options, directions for using 5-FU, expected spectrum of side effects, and how to minimize the discomfort of treatment side effects. Patients had field treatment limited to areas with clinically apparent AKs on the face and ears. They were prescribed 5-FU cream 5% twice daily.

One physician, one nurse practitioner, and one registered nurse were present at each 1-hour clinic. Patients arrived and were checked in individually by the providers. At check-in, the provider handed the patient a printout of his/her current medication list and a pen to make any necessary corrections. This list was reviewed privately with the patient so the provider could reconcile the medication list and review the patient’s medical history and so the patient could provide informed consent. After, the patient had the opportunity to select a seat from chairs arranged in a circle. There was a live PowerPoint presentation given at the beginning of the clinic with a question-and-answer session immediately following that contained information about the disease and medication process. Clinicians assisted the patients with the initial application of 5-FU in the large group room, and each patient received a handout with information about AKs and a 40-g tube of the 5-FU cream.

 

This same group then met again 2 weeks later, at which time most patients were experiencing expected adverse skin reactions. At that time, there was a 10-minute live presentation that congratulated the patients on their success in the treatment process, reviewed what to expect in the following weeks, and reinforced the importance of future sun-protective practices. At each visit, photographs and feedback about the group setting were obtained in the large group room. After photographing and rating each patient’s skin reaction severity, the clinicians advised each patient either to continue the 5-FU medication for another week or to discontinue it and apply the triamcinolone cream 0.1% up to 4 times daily as needed for up to 7 days. Each patient received the prescription corticosteroid cream and a gift, courtesy of the VA Voluntary Service Program, of a 360-degree brimmed hat and sunscreen. Time for questions or concerns was available at both sessions.

Data Collection
We reviewed medical records via the Computerized Patient Record System, a nationally accessible electronic health record system, for all patients who participated in the SMA visits from September 2016 through March 2017. Any patient who attended the initial visit but declined therapy at that time was excluded.

Outcomes included attendance at both appointments, stated completion of 14 days of 5-FU treatment, and evidence of 5-FU use according to a validated numeric scale of skin reaction severity.¹⁴ We recorded telephone calls and other dermatology clinic and teledermatology appointments during the 3 weeks after the first appointment and the number of dermatology clinic appointments 6 months before and after the SMA for side effects related to 5-FU treatment. Feedback about treatment in the group setting was obtained at both visits.

Results

A total of 16 male patients attended the SMAs, and 14 attended both sessions. Of the 2 patients who were excluded from the study, 1 declined to be scheduled for the second group appointment, and the other was scheduled and confirmed but did not come for his appointment. The mean age was 72 years.

Of the 14 study patients who attended both sessions of the group clinic, 10 stated that they completed 2 weeks of 5-FU therapy, and the other 4 stated that they completed at least 11 days. Results of the validated scale used by clinicians during the second visit to grade the patients’ 5-FU reactions showed that all 14 patients demonstrated at least some expected adverse reactions (eTable). Eleven of 14 patients showed crusting and erosion; 13 showed grade 2 or higher erythema severity. One patient who stopped treatment after 11 days telephoned the dermatology clinic within 1 week of his second SMA. Another patient who stopped treatment after 11 days had a separate dermatology surgery clinic appointment within the 3-week period after starting 5-FU for a recent basal cell carcinoma excision. None of the 14 patients had a dermatology appointment scheduled within 6 months before or after for a 5-FU adverse reaction. One patient who completed the 14-day course was referred to teledermatology for insect bites within that period.

None of the patients were prophylaxed for herpes simplex virus during the treatment period, and none developed a herpes simplex virus eruption during this study. None of the patients required antibiotics for secondary impetiginization of the treatment site.

The verbal feedback about the group setting from patients who completed both appointments was uniformly positive, with specific appreciation for the normalization of the treatment process and opportunity to ask questions with their peers. At the conclusion of the second appointment, all of the patients reported an increased understanding of their condition and the importance of future sun-protective behaviors.

 

Comment

Shared medical appointments promote treatment adherence in patients with chronic heart failure and diabetes mellitus through efficient resource use, improvement of access to care, and promotion of behavioral change through group support.^7-13 Within the dermatology literature, SMAs are more profitable than regular clinic appointments.¹⁵ In SMAs designed to improve patient education for preoperative consultations for Mohs micrographic surgery, patient satisfaction reported in postvisit surveys was high, with 84.7% of 149 patients reporting they found the session useful, highlighting how SMAs have potential as practical alternatives to regular medical appointments.¹⁶ Similarly, the feedback about the group setting from our patients who completed both appointments was uniformly positive, with specific appreciation for the normalization of the treatment process and opportunity to ask questions with their peers.

The group setting—where patients were interacting with peers undergoing the same treatment—provided an encouraging environment during the course of 5-FU therapy, resulting in a positive treatment experience. Additionally, at the conclusion of the second visit, patients reported an increased understanding of their condition and the importance of future sun-protective behaviors, further demonstrating the impact of this pilot initiative.

The Veterans Affairs’ Current Procedural Terminology code for a group clinic is 99078. Veterans Affairs medical centers and private practices have different approaches to billing and compensation. As more accountable care organizations are formed, there may be a different mixture of ways for handling these SMAs.

Limitations
Our study is limited by the small sample size, selection bias, and self-reported measure of adherence. Adherence to 5-FU is excellent without group support, and without a control group, it is unclear how beneficial the group setting was for adherence.¹⁷ The presence of the expected skin reactions at the 2-week return visit cannot account for adherence during the interval between the visits, and this close follow-up may be responsible for the high adherence in this group setting. The major side effects with 5-FU are short-term. Nonetheless, longer-term follow-up would be helpful and a worthy future endeavor.

Veterans share a common bond of military service that may not be shared in a typical private practice setting, which may have facilitated success of this pilot study. We recommend group clinics be evaluated independently in private practices and other systems. However, despite these limitations, the patients in the SMAs demonstrated positive reactions to 5-FU therapy, suggesting the potential for utilizing group clinics as a practical alternative to regular medical appointments.

Conclusion

Our pilot group clinics for AK treatment and chemoprevention of SCC with 5-FU suggest that this model is well received. The group format, which demonstrated uniformly positive reactions to 5-FU therapy, shows promise in battling an epidemic of skin cancer that demands cost-effective interventions.

Squamous cell carcinoma (SCC) has an estimated incidence of more than 2.5 million cases per year in the United States.¹ Its precursor lesion, actinic keratosis (AK), had an estimated prevalence of 39.5 million cases in the United States in 2004.² The dermatology clinic at the Providence VA Medical Center in Rhode Island exerts consistent efforts to treat both SCC and AK by prescribing topical 5-fluorouracil (5-FU) and lifestyle changes that include avoiding sun exposure, wearing protective clothing, and using effective sunscreen.³ A single course of topical 5-FU in veterans has been shown to decrease the risk for SCC by 74% during the year after treatment and also improve AK clearance rates.^4,5

Effectiveness of 5-FU for secondary prevention can be decreased by patient misunderstandings, such as applying 5-FU for too short a time or using the corticosteroid cream prematurely, as well as patient nonadherence due to expected adverse skin reactions to 5-FU.⁶ Education and reassurance before and during therapy maximize patient compliance but can be difficult to accomplish in clinics when time is in short supply. During standard 5-FU treatment at the Providence VA Medical Center, the provider prescribes 5-FU and posttherapy corticosteroid cream at a clinic visit after an informed consent process that includes reviewing with the patient a color handout depicting the expected adverse skin reaction. Patients who later experience severe inflammation and anxiety call the clinic and are overbooked as needed.

To address the practical obstacles to the patient experience with topical 5-FU therapy, we developed a group chemoprevention clinic based on the shared medical appointment (SMA) model. Shared medical appointments, during which multiple patients are scheduled at the same visit with 1 or more health care providers, promote patient risk reduction and guideline adherence in complex diseases, such as chronic heart failure and diabetes mellitus, through efficient resource use, improvement of access to care, and promotion of behavioral changes through group support.^7-13 To increase efficiency in the group chemoprevention clinic, we integrated dermatology nurses and nurse practitioners from the chronic care model into the group medical visits, which ran from September 2016 through March 2017. Because veterans could interact with peers undergoing the same treatment, we hypothesized that use of the cream in a group setting would provide positive reinforcement during the course of therapy, resulting in a positive treatment experience. We conducted a retrospective review of medical records of the patients involved in this pilot study to evaluate this model.

Methods

Institutional review board approval was obtained from the Providence VA Medical Center. Informed consent was waived because this study was a retrospective review of medical records.

Study Population
We offered participation in a group chemoprevention clinic based on the SMA model for patients of the dermatology clinic at the Providence VA Medical Center who were planning to start 5-FU in the fall of 2016. Patients were asked if they were interested in participating in a group clinic to receive their 5-FU treatment. Patients who were established dermatology patients within the Veterans Affairs system and had scheduled annual full-body skin examinations were included; patients were not excluded if they had a prior diagnosis of AK but had not been previously treated with 5-FU.

Design
Each SMA group consisted of 3 to 4 patients who met initially to receive the 5-FU medication and attend a 10-minute live presentation that included information on the dangers and causes of SCC and AK, treatment options, directions for using 5-FU, expected spectrum of side effects, and how to minimize the discomfort of treatment side effects. Patients had field treatment limited to areas with clinically apparent AKs on the face and ears. They were prescribed 5-FU cream 5% twice daily.

One physician, one nurse practitioner, and one registered nurse were present at each 1-hour clinic. Patients arrived and were checked in individually by the providers. At check-in, the provider handed the patient a printout of his/her current medication list and a pen to make any necessary corrections. This list was reviewed privately with the patient so the provider could reconcile the medication list and review the patient’s medical history and so the patient could provide informed consent. After, the patient had the opportunity to select a seat from chairs arranged in a circle. There was a live PowerPoint presentation given at the beginning of the clinic with a question-and-answer session immediately following that contained information about the disease and medication process. Clinicians assisted the patients with the initial application of 5-FU in the large group room, and each patient received a handout with information about AKs and a 40-g tube of the 5-FU cream.

 

This same group then met again 2 weeks later, at which time most patients were experiencing expected adverse skin reactions. At that time, there was a 10-minute live presentation that congratulated the patients on their success in the treatment process, reviewed what to expect in the following weeks, and reinforced the importance of future sun-protective practices. At each visit, photographs and feedback about the group setting were obtained in the large group room. After photographing and rating each patient’s skin reaction severity, the clinicians advised each patient either to continue the 5-FU medication for another week or to discontinue it and apply the triamcinolone cream 0.1% up to 4 times daily as needed for up to 7 days. Each patient received the prescription corticosteroid cream and a gift, courtesy of the VA Voluntary Service Program, of a 360-degree brimmed hat and sunscreen. Time for questions or concerns was available at both sessions.

Data Collection
We reviewed medical records via the Computerized Patient Record System, a nationally accessible electronic health record system, for all patients who participated in the SMA visits from September 2016 through March 2017. Any patient who attended the initial visit but declined therapy at that time was excluded.

Outcomes included attendance at both appointments, stated completion of 14 days of 5-FU treatment, and evidence of 5-FU use according to a validated numeric scale of skin reaction severity.¹⁴ We recorded telephone calls and other dermatology clinic and teledermatology appointments during the 3 weeks after the first appointment and the number of dermatology clinic appointments 6 months before and after the SMA for side effects related to 5-FU treatment. Feedback about treatment in the group setting was obtained at both visits.

Results

A total of 16 male patients attended the SMAs, and 14 attended both sessions. Of the 2 patients who were excluded from the study, 1 declined to be scheduled for the second group appointment, and the other was scheduled and confirmed but did not come for his appointment. The mean age was 72 years.

Of the 14 study patients who attended both sessions of the group clinic, 10 stated that they completed 2 weeks of 5-FU therapy, and the other 4 stated that they completed at least 11 days. Results of the validated scale used by clinicians during the second visit to grade the patients’ 5-FU reactions showed that all 14 patients demonstrated at least some expected adverse reactions (eTable). Eleven of 14 patients showed crusting and erosion; 13 showed grade 2 or higher erythema severity. One patient who stopped treatment after 11 days telephoned the dermatology clinic within 1 week of his second SMA. Another patient who stopped treatment after 11 days had a separate dermatology surgery clinic appointment within the 3-week period after starting 5-FU for a recent basal cell carcinoma excision. None of the 14 patients had a dermatology appointment scheduled within 6 months before or after for a 5-FU adverse reaction. One patient who completed the 14-day course was referred to teledermatology for insect bites within that period.

None of the patients were prophylaxed for herpes simplex virus during the treatment period, and none developed a herpes simplex virus eruption during this study. None of the patients required antibiotics for secondary impetiginization of the treatment site.

The verbal feedback about the group setting from patients who completed both appointments was uniformly positive, with specific appreciation for the normalization of the treatment process and opportunity to ask questions with their peers. At the conclusion of the second appointment, all of the patients reported an increased understanding of their condition and the importance of future sun-protective behaviors.

 

Comment

Shared medical appointments promote treatment adherence in patients with chronic heart failure and diabetes mellitus through efficient resource use, improvement of access to care, and promotion of behavioral change through group support.^7-13 Within the dermatology literature, SMAs are more profitable than regular clinic appointments.¹⁵ In SMAs designed to improve patient education for preoperative consultations for Mohs micrographic surgery, patient satisfaction reported in postvisit surveys was high, with 84.7% of 149 patients reporting they found the session useful, highlighting how SMAs have potential as practical alternatives to regular medical appointments.¹⁶ Similarly, the feedback about the group setting from our patients who completed both appointments was uniformly positive, with specific appreciation for the normalization of the treatment process and opportunity to ask questions with their peers.

The group setting—where patients were interacting with peers undergoing the same treatment—provided an encouraging environment during the course of 5-FU therapy, resulting in a positive treatment experience. Additionally, at the conclusion of the second visit, patients reported an increased understanding of their condition and the importance of future sun-protective behaviors, further demonstrating the impact of this pilot initiative.

The Veterans Affairs’ Current Procedural Terminology code for a group clinic is 99078. Veterans Affairs medical centers and private practices have different approaches to billing and compensation. As more accountable care organizations are formed, there may be a different mixture of ways for handling these SMAs.

Limitations
Our study is limited by the small sample size, selection bias, and self-reported measure of adherence. Adherence to 5-FU is excellent without group support, and without a control group, it is unclear how beneficial the group setting was for adherence.¹⁷ The presence of the expected skin reactions at the 2-week return visit cannot account for adherence during the interval between the visits, and this close follow-up may be responsible for the high adherence in this group setting. The major side effects with 5-FU are short-term. Nonetheless, longer-term follow-up would be helpful and a worthy future endeavor.

Veterans share a common bond of military service that may not be shared in a typical private practice setting, which may have facilitated success of this pilot study. We recommend group clinics be evaluated independently in private practices and other systems. However, despite these limitations, the patients in the SMAs demonstrated positive reactions to 5-FU therapy, suggesting the potential for utilizing group clinics as a practical alternative to regular medical appointments.

Conclusion

Our pilot group clinics for AK treatment and chemoprevention of SCC with 5-FU suggest that this model is well received. The group format, which demonstrated uniformly positive reactions to 5-FU therapy, shows promise in battling an epidemic of skin cancer that demands cost-effective interventions.