Innovative compensation systems aimed at achieving fairness, consistency, and transparency in salaries among surgeons in academic medical centers can go a long way to closing the gender pay gap.

At the University of Alabama at Birmingham, research showed that a newly adopted compensation system – one not even designed to address gender disparities – boosted the salaries of female surgeons from 46% to 72% of the salaries of their male colleagues. A gender salary gap also narrowed at Oregon Health & Sciences University, Portland, after a new compensation policy was put into place.

Innovative compensation systems aimed at achieving fairness, consistency, and transparency in salaries among surgeons in academic medical centers can go a long way to closing the gender pay gap.

At the University of Alabama at Birmingham, research showed that a newly adopted compensation system – one not even designed to address gender disparities – boosted the salaries of female surgeons from 46% to 72% of the salaries of their male colleagues. A gender salary gap also narrowed at Oregon Health & Sciences University, Portland, after a new compensation policy was put into place.

Innovative compensation systems aimed at achieving fairness, consistency, and transparency in salaries among surgeons in academic medical centers can go a long way to closing the gender pay gap.

At the University of Alabama at Birmingham, research showed that a newly adopted compensation system – one not even designed to address gender disparities – boosted the salaries of female surgeons from 46% to 72% of the salaries of their male colleagues. A gender salary gap also narrowed at Oregon Health & Sciences University, Portland, after a new compensation policy was put into place.

The National Defense Appropriations Act for fiscal year 2009, Subtitle B, waived copayments for preventive cancer screening services for all TRICARE beneficiaries, excluding Medicare-eligible beneficiaries.¹ These preventive services include screening for colorectal cancer (CRC), breast cancer, and cervical cancer based on current guidelines (eAppendix1).

Despite having unrestricted access to these cancer screenings, TRICARE Prime beneficiaries report overall screening completion rates that are below the national commercial benchmarks established by the Healthcare Effectiveness Data and Information Set (HEDIS) for all 3 cancer types.² Specifically, among TRICARE Prime beneficiaries enrolled in the western region of the U.S. in October 2013, the reported breast cancer screening rate was 61.6% (43,138/69,976) for women aged 42 to 69 years, which is well below the HEDIS 75th percentile of 76%. Similarly, the reported rate of cervical cancer screening among women aged 24 to 64 years was 68.3% (63,523/92,946), well below the HEDIS 75th percentile of 79%. Last, the reported rate of CRC screening among male and female TRICARE Prime members aged 51 to 75 years was 61.6% (52,860/85,827), also below the 2013 HEDIS 75th percentile of 63% based on internal review of TRICARE data used for HEDIS reporting.

Given the reported low screening rates, the Defense Health Agency (DHA) performed a cross-sectional survey to assess TRICARE Prime West region beneficiaries’ knowledge and understanding of preventive health screening, specifically for breast cancer, cervical cancer, and CRC, and to identify any potential barriers to access for these screenings.

Methods

A mostly closed-ended, 42-item telephone survey was designed and conducted (eAppendix2)

All women participating in the survey, regardless of age, were asked questions regarding cervical cancer screening. Women aged ≥ 42 years additionally were asked a second set of survey questions specific to breast cancer screening, and women aged between 51 and 64 years were asked a third set of questions related to CRC screening. The ages selected were 1 to 2 years after the recommended age for the respective screening to ensure adequate follow-up time for the member to obtain the screening. Men included in the survey were asked questions related only to CRC screening.

The target survey sample was 3,500 beneficiaries, separated into the following 4 strata: women aged 21 to 64 years of age enrolled in the direct care system (n = 1,250); women aged 21 to 64 years enrolled in the purchased (commercial) care network (n = 1,250); men aged 51 to 64 years enrolled in the direct care system (n = 500); and men aged 51 to 64 years enrolled in the purchased care network (n = 500). The random sample was drawn from an overall population of about 35,000 members. Sampling was performed without replacement until the target number of surveys was achieved. Survey completion was defined as the respondent having reached the end of the survey questionnaire but not necessarily having answered every question.

Data Elements

The preventive health survey collected information on beneficiaries’ knowledge of and satisfaction with their PCM, the primary location where they sought health care in the previous 12 months, preference for scheduling cancer screening tests, and general knowledge about the frequency and type of screening for breast, cervical, and colorectal cancers. Responses were scored based on guidelines effective as of 2009. In addition, the survey collected information on the beneficiary’s overall health status, current age, highest level of education achieved, current employment status, place of residence (on or off a military installation), race, and whether the beneficiary carried other health insurance aside from TRICARE.

Survey Mode and Fielding

A sampling population of eligible beneficiaries was created from a database of all TRICARE Prime beneficiaries. An automated system was used to randomly draw potential participants from the sample. Survey interviewers were given the beneficiary’s name and telephone number but no other identifiable information. Phone numbers from the sample were dialed up to 6 times before the number was classified as a “no answer.” Interviewers read to each beneficiary a statement describing the survey and participation risk and benefits and explained that participation was voluntary and the participant could end the survey at any time without penalty or prejudice. The survey commenced only after verbal consent was obtained.

Sample Weighting and Statistical Analysis

Each survey record was weighted to control for potential bias associated with unequal rates of noncoverage and nonresponse in the sampled population. A design weight was calculated as the ratio of the frame size and the sample size in each stratum. For each stratum, an adjusted response rate (RR) was calculated as the number of completed surveys divided by the number of eligible respondents. Since all respondents were eligible, the RR was not adjusted. The ratio of the design weight to the adjusted RR was calculated and assigned to each survey.

Frequency distributions and descriptive statistics were calculated for all close-ended survey items. Open-ended survey items were summarized and assessed qualitatively. When appropriate, open-ended responses were categorized and included in descriptive analyses. No formal statistical testing was performed.

Results

A total of 6,563 beneficiaries were contacted, and 3,688 agreed to participate (56%), resulting in 3,500 TRICARE beneficiaries completing the survey (95% completion rate), of whom 71% (2,500) were female. The overall cooperation rates were similar across the 4 strata. Interviews ceased once 3,500 surveys were completed. The largest distribution of respondents was aged between 55 and 64 years (37%) (Table 1). Respondents aged 21 to 24 years comprised the smallest percentage of the sample (7%). Nearly a third of respondents were dependents of ADSMs (30%), another 30% were retirees, and most respondents self-identified as white (Table 1).

Barriers to Screening

A series of survey questions was asked about specific barriers to cancer screening, including the convenience of appointment times for the respondent’s last cancer screening. The majority (69%, 2,415 of 3,500) responded that the appointment times were convenient. Among those who stated that times were not convenient and those who had not scheduled an examination, 66% responded that they did not know or were not sure how to schedule a cancer screening test.

Screening Preferences

Less than half of survey respondents (48%) reported that they received screening guideline information from their physician or provider; 24% reported that they performed their own research. Only 9% reported that they learned about the guidelines through TRICARE materials, and 7% of respondents indicated that media, family, or friends were their source of screening information.

The survey respondents who indicated that they had not scheduled a screening examination were asked when (time of day) they preferred to have a screening. Less than half (47%) reported that varying available appointment times would not affect their ability to obtain screening. One-quarter preferred times for screening during working hours, 20% preferred times after working hours, 6% preferred times before working hours, and 2% responded that they were unsure or did not know. The majority (89%) reported that they would prefer to receive all available screenings on the same day if possible.

Breast Cancer Screening

Nearly all (98%) of the 1,100 women aged between 42 and 64 years reported having received a mammogram. These women were asked a specific subset of questions related to breast cancer screening. Respondents were asked to state the recommended age at which women should begin receiving mammogram screenings. More than half (55%) provided the correct response (40 years old, per the U.S. Preventive Services Task Force guidelines).^3,4 About three-quarters of respondents (789) correctly responded annually to the question regarding how often women should receive mammograms.

The survey also sought to identify barriers that prevented women from obtaining necessary breast cancer screening. However, the majority surveyed (85%) noted that the question was not applicable because they typically scheduled screening appointments. Only a few (3%) reported factors such as either themselves or someone they know having had a negative experience, discomfort, pain, or concerns of a falsepositive result as reasons for not obtaining breast cancer screening. Of the 112 respondents to the open-ended question, 25% reported that their schedules prevented them from scheduling a mammogram in the past; 12% reported that an inconvenient clinic location, appointment time, or process prevented them from receiving a screening; and 13% reported forgetting to schedule the screening (Table 2).

Cervical Cancer Screening

Female respondents aged between 21 and 64 years (n = 2,432) were asked about the recommended age at which women should begin receiving cervical cancer screening. Only 1% of respondents provided the correct response (that screening begins at 21 years of age per the U.S. Preventive Services Task Force Report guidelines), while 88% provided an incorrect response, and 11% were unsure or did not provide any response.⁵ Among all respondents, 98% reported having had a cervical cancer screening.

Respondents were asked how frequently women should have a Papanicolaou (Pap) test. Responses such as “2 to 3 years,” “2 years,” or “every other year” were labeled as correct, whereas responses such as “every 6 months” or “greater than 3 years” were labeled as incorrect. Just 12% of respondents provided a correct response, whereas 86% answered incorrectly, and 2% did not answer or did not know. Of those who answered incorrectly, the most common response was “annually” or “every year,” with no notable differences according to race, age, or beneficiary category.

To better understand barriers to screening, respondents were asked to identify reasons they might not have sought cervical cancer screening. The majority (84%) reported that they typically scheduled appointments and that the question was not applicable. However, among 228 respondents who provided an open-ended response and who had not previously undergone a hysterectomy, 8% stated that they had received no reminder or that they lacked sufficient information to schedule the appointment, 21% forgot to schedule, 18% reported a scheduling conflict or difficulty in receiving care, and 13% noted that they did not believe in annual screening (Table 2).

Colorectal Cancer Screening

Eighty-seven percent of eligible respondents (n = 1,734) reported having ever had a sigmoidoscopy and/or colonoscopy. Respondents were asked for their understanding of the recommended age for men and women to begin CRC screening.6 Nearly three-quarters of respondents provided a correct response (n = 1,225), compared with 23% of respondents (n = 407) who answered incorrectly and 6% (n = 102) who did not provide a response or stated they did not know. Correct responses were numerically higher among white respondents (73%) compared with black (62%) and other (62%) respondents as well as among persons aged < 60 years (73%) vs those aged > 60 years (67%).

Respondents aged between 51 and 64 years were asked how often the average person should receive colon cancer screenings. The most common response was that screening should occur every 5 years (33%) followed by every 10 years (26%). This aligns with the U.S. Preventive Services Task Force’s recommendations for flexible sigmoidoscopy every 5 years or colonoscopy every 10 years.

Eligible respondents were asked to identify reasons they did not seek CRC screening. Eighty-six percent of respondents indicated that they typically scheduled CRC screening and that the question was not applicable. Among respondents who provided an open-ended response, 26% cited feeling uncomfortable with the procedure, 15% cited forgetting to schedule a screening, 15% noted a lack of information on screening, and 11% reported no need for screening (Table 2). Among the 1,734 respondents, 80% reported that they would prefer a fecal occult blood test (FOBT) over either a colonoscopy or a sigmoidoscopy. Only 51% reported that their PCM had previously discussed the different types of CRC screenings at some point.

Discussion

The purpose of this large, representative survey was to obtain information on beneficiaries’ knowledge, perceived barriers, and beliefs regarding breast, cervical, and colorectal cancer screenings to identify factors contributing to low completion rates. As far as is known, this is the first study to address these questions in a TRICARE population. Overall, the findings suggest that beneficiaries consider cancer screening important, largely relying on their PCM or their research to better understand how and when to obtain such screenings. The majority received 1 or more screenings prior to the survey, but there were some common knowledge gaps about how to schedule screening appointments, relevant TRICARE medical benefits, and the current recommendations regarding screening timing and frequency. A commonly reported issue across all surveyed groups was inconvenient screening times.

More than half (55%) of respondents correctly noted that breast cancer screening begins at age 40 years (based on recommendations at the time the survey was conducted), and 72% understood when screening should occur. Despite access to care, inconvenient schedules and testing locations were considered the biggest barriers to regularly obtaining a mammogram. There are few studies on knowledge of breast cancer screening in an insured population available for comparison.^7-10 One study of medically insured black and non-Hispanic women aged 43 to 49 years showed that lack of reminders or knowledge about the need for mammograms, cost, being too busy, and forgetting to schedule appointments were all factors associated with nonadherence to repeat mammography examinations.⁸ In an integrative review published in 2000, authors cited that among 8 of 13 relevant studies, the major barrier to receiving a recommended mammogram was lack of physician recommendation.⁷

For cervical cancer screening, few respondents (1%) correctly identified the age for initiation of screening, and just 12% correctly identified the frequency of screening. These findings are consistent with those of other studies, suggesting a general misunderstanding
about Pap tests in the U.S. and among low-income women.^11,12 Reported barriers to screening were uncommon but included scheduling conflicts and lack of reminders or information and were consistent with barriers cited in prior studies.^13,14 A few respondents (13%) noted that they did not believe in annual screening, which is similar to the findings of Decker and colleagues who cited lack of knowledge about the test and belief that screening is of no benefit as reasons for failure to get a recommended Pap test.¹³ These findings suggest a need to improve patientprovider communication and to provide more patient educational materials about the importance of cervical cancer screening.

A large proportion (71%) gave the correct response regarding the appropriate age to initiate CRC screening. Discomfort with the procedure, belief that the screening is unnecessary, or lack of physician’s recommendation were noted barriers to CRC screening. These findings are similar to those reported elsewhere in non-TRICARE populations.^15-20 Two focus groups included participants with little knowledge about CRC screening, such as risk factors and symptoms, and expressed fear and embarrassment about CRC and screening. Few of the focus group participants were aware of the available options for screening, and some were confused about the purpose and benefits of the various screening modalities.¹⁶

A Health Information National Trends survey reported that 24% participants had not received a colonoscopy or a sigmoidoscopy because their PCM did not order it or say that it was necessary.¹⁵ The reported perceived barriers included fear of an adverse finding, injury to the colon from screening, and embarrassment. A study performed in 1,901 Medicare-insured individuals with no history of CRC cited lack of knowledge/awareness and no physician order as the most common reasons for not undergoing CRC screening.¹⁸

Strengths and Limitations

A major strength of the current survey is the 56% completion rate, which far exceeds other survey participation rates that were as low as 9%.²¹ A second strength is the scope of the survey to capture information on not 1 but 3 different cancer screening practices in a unique population who receive preventive screenings at low to no cost.

There are a few study limitations. The majority of respondents identified as white (80%), which does not fully align with the racial distribution of the TRICARE Prime population in the West Region, which is about 68% white. This higher proportion of white respondents may affect the ability to generalize findings to other populations. However, given the open access to care, race should not be a major factor contributing to screening decisions. Another potential limitation to the generalizability of the study is that the age of the respondents was capped at 64 years. Considering that some of the reported barriers to screening were “too busy” or “scheduling conflict,” a study population that included respondents aged ≥ 65 years (who might be more likely to be retired) might report lower rates of these schedule-related barriers.

A third limitation is that most questions about prior screenings pertained to any time in the past, and, therefore, limited the ability to identify current factors leading to lower screening rates. Last, the survey was developed prior to the 2012 changes in cervical and breast cancer screening recommendations and was therefore scored based on prior recommendations. Given that the goal was to assess knowledge and barriers, results are not expected to differ greatly if they are scored using the newer guidelines.

Conclusion

Findings from this cross-sectional survey indicate high levels of knowledge among TRICARE West Region beneficiaries regarding when and how often screening for breast cancer, cervical cancer, and CRC should occur. To encourage TRICARE beneficiaries to seek and obtain recommended and covered cancer screenings, further efforts are needed, including more education about the importance of screening and how to obtain screening. The survey results suggest that TRICARE Prime beneficiaries view cancer screening as important for overall health but they require (and also may desire) more frequent scheduling reminders, education, and more options for scheduling. Newer modalities for communicating with beneficiaries, such as automated telephone appointment reminders, reminder texts, online appointment scheduling, educational blogs, podcasts on cancer screening, extended appointment hours, or unconventional strategies to bundle screening services, are tools that could be used by providers to achieve greater compliance with cancer screening recommendations.

Author Disclosure
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

Click here to read the digital edition.

The National Defense Appropriations Act for fiscal year 2009, Subtitle B, waived copayments for preventive cancer screening services for all TRICARE beneficiaries, excluding Medicare-eligible beneficiaries.¹ These preventive services include screening for colorectal cancer (CRC), breast cancer, and cervical cancer based on current guidelines (eAppendix1).

Despite having unrestricted access to these cancer screenings, TRICARE Prime beneficiaries report overall screening completion rates that are below the national commercial benchmarks established by the Healthcare Effectiveness Data and Information Set (HEDIS) for all 3 cancer types.² Specifically, among TRICARE Prime beneficiaries enrolled in the western region of the U.S. in October 2013, the reported breast cancer screening rate was 61.6% (43,138/69,976) for women aged 42 to 69 years, which is well below the HEDIS 75th percentile of 76%. Similarly, the reported rate of cervical cancer screening among women aged 24 to 64 years was 68.3% (63,523/92,946), well below the HEDIS 75th percentile of 79%. Last, the reported rate of CRC screening among male and female TRICARE Prime members aged 51 to 75 years was 61.6% (52,860/85,827), also below the 2013 HEDIS 75th percentile of 63% based on internal review of TRICARE data used for HEDIS reporting.

Given the reported low screening rates, the Defense Health Agency (DHA) performed a cross-sectional survey to assess TRICARE Prime West region beneficiaries’ knowledge and understanding of preventive health screening, specifically for breast cancer, cervical cancer, and CRC, and to identify any potential barriers to access for these screenings.

Methods

A mostly closed-ended, 42-item telephone survey was designed and conducted (eAppendix2)

All women participating in the survey, regardless of age, were asked questions regarding cervical cancer screening. Women aged ≥ 42 years additionally were asked a second set of survey questions specific to breast cancer screening, and women aged between 51 and 64 years were asked a third set of questions related to CRC screening. The ages selected were 1 to 2 years after the recommended age for the respective screening to ensure adequate follow-up time for the member to obtain the screening. Men included in the survey were asked questions related only to CRC screening.

The target survey sample was 3,500 beneficiaries, separated into the following 4 strata: women aged 21 to 64 years of age enrolled in the direct care system (n = 1,250); women aged 21 to 64 years enrolled in the purchased (commercial) care network (n = 1,250); men aged 51 to 64 years enrolled in the direct care system (n = 500); and men aged 51 to 64 years enrolled in the purchased care network (n = 500). The random sample was drawn from an overall population of about 35,000 members. Sampling was performed without replacement until the target number of surveys was achieved. Survey completion was defined as the respondent having reached the end of the survey questionnaire but not necessarily having answered every question.

Data Elements

The preventive health survey collected information on beneficiaries’ knowledge of and satisfaction with their PCM, the primary location where they sought health care in the previous 12 months, preference for scheduling cancer screening tests, and general knowledge about the frequency and type of screening for breast, cervical, and colorectal cancers. Responses were scored based on guidelines effective as of 2009. In addition, the survey collected information on the beneficiary’s overall health status, current age, highest level of education achieved, current employment status, place of residence (on or off a military installation), race, and whether the beneficiary carried other health insurance aside from TRICARE.

Survey Mode and Fielding

A sampling population of eligible beneficiaries was created from a database of all TRICARE Prime beneficiaries. An automated system was used to randomly draw potential participants from the sample. Survey interviewers were given the beneficiary’s name and telephone number but no other identifiable information. Phone numbers from the sample were dialed up to 6 times before the number was classified as a “no answer.” Interviewers read to each beneficiary a statement describing the survey and participation risk and benefits and explained that participation was voluntary and the participant could end the survey at any time without penalty or prejudice. The survey commenced only after verbal consent was obtained.

Sample Weighting and Statistical Analysis

Each survey record was weighted to control for potential bias associated with unequal rates of noncoverage and nonresponse in the sampled population. A design weight was calculated as the ratio of the frame size and the sample size in each stratum. For each stratum, an adjusted response rate (RR) was calculated as the number of completed surveys divided by the number of eligible respondents. Since all respondents were eligible, the RR was not adjusted. The ratio of the design weight to the adjusted RR was calculated and assigned to each survey.

Frequency distributions and descriptive statistics were calculated for all close-ended survey items. Open-ended survey items were summarized and assessed qualitatively. When appropriate, open-ended responses were categorized and included in descriptive analyses. No formal statistical testing was performed.

Results

A total of 6,563 beneficiaries were contacted, and 3,688 agreed to participate (56%), resulting in 3,500 TRICARE beneficiaries completing the survey (95% completion rate), of whom 71% (2,500) were female. The overall cooperation rates were similar across the 4 strata. Interviews ceased once 3,500 surveys were completed. The largest distribution of respondents was aged between 55 and 64 years (37%) (Table 1). Respondents aged 21 to 24 years comprised the smallest percentage of the sample (7%). Nearly a third of respondents were dependents of ADSMs (30%), another 30% were retirees, and most respondents self-identified as white (Table 1).

Barriers to Screening

A series of survey questions was asked about specific barriers to cancer screening, including the convenience of appointment times for the respondent’s last cancer screening. The majority (69%, 2,415 of 3,500) responded that the appointment times were convenient. Among those who stated that times were not convenient and those who had not scheduled an examination, 66% responded that they did not know or were not sure how to schedule a cancer screening test.

Screening Preferences

Less than half of survey respondents (48%) reported that they received screening guideline information from their physician or provider; 24% reported that they performed their own research. Only 9% reported that they learned about the guidelines through TRICARE materials, and 7% of respondents indicated that media, family, or friends were their source of screening information.

The survey respondents who indicated that they had not scheduled a screening examination were asked when (time of day) they preferred to have a screening. Less than half (47%) reported that varying available appointment times would not affect their ability to obtain screening. One-quarter preferred times for screening during working hours, 20% preferred times after working hours, 6% preferred times before working hours, and 2% responded that they were unsure or did not know. The majority (89%) reported that they would prefer to receive all available screenings on the same day if possible.

Breast Cancer Screening

Nearly all (98%) of the 1,100 women aged between 42 and 64 years reported having received a mammogram. These women were asked a specific subset of questions related to breast cancer screening. Respondents were asked to state the recommended age at which women should begin receiving mammogram screenings. More than half (55%) provided the correct response (40 years old, per the U.S. Preventive Services Task Force guidelines).^3,4 About three-quarters of respondents (789) correctly responded annually to the question regarding how often women should receive mammograms.

The survey also sought to identify barriers that prevented women from obtaining necessary breast cancer screening. However, the majority surveyed (85%) noted that the question was not applicable because they typically scheduled screening appointments. Only a few (3%) reported factors such as either themselves or someone they know having had a negative experience, discomfort, pain, or concerns of a falsepositive result as reasons for not obtaining breast cancer screening. Of the 112 respondents to the open-ended question, 25% reported that their schedules prevented them from scheduling a mammogram in the past; 12% reported that an inconvenient clinic location, appointment time, or process prevented them from receiving a screening; and 13% reported forgetting to schedule the screening (Table 2).

Cervical Cancer Screening

Female respondents aged between 21 and 64 years (n = 2,432) were asked about the recommended age at which women should begin receiving cervical cancer screening. Only 1% of respondents provided the correct response (that screening begins at 21 years of age per the U.S. Preventive Services Task Force Report guidelines), while 88% provided an incorrect response, and 11% were unsure or did not provide any response.⁵ Among all respondents, 98% reported having had a cervical cancer screening.

Respondents were asked how frequently women should have a Papanicolaou (Pap) test. Responses such as “2 to 3 years,” “2 years,” or “every other year” were labeled as correct, whereas responses such as “every 6 months” or “greater than 3 years” were labeled as incorrect. Just 12% of respondents provided a correct response, whereas 86% answered incorrectly, and 2% did not answer or did not know. Of those who answered incorrectly, the most common response was “annually” or “every year,” with no notable differences according to race, age, or beneficiary category.

To better understand barriers to screening, respondents were asked to identify reasons they might not have sought cervical cancer screening. The majority (84%) reported that they typically scheduled appointments and that the question was not applicable. However, among 228 respondents who provided an open-ended response and who had not previously undergone a hysterectomy, 8% stated that they had received no reminder or that they lacked sufficient information to schedule the appointment, 21% forgot to schedule, 18% reported a scheduling conflict or difficulty in receiving care, and 13% noted that they did not believe in annual screening (Table 2).

Colorectal Cancer Screening

Eighty-seven percent of eligible respondents (n = 1,734) reported having ever had a sigmoidoscopy and/or colonoscopy. Respondents were asked for their understanding of the recommended age for men and women to begin CRC screening.6 Nearly three-quarters of respondents provided a correct response (n = 1,225), compared with 23% of respondents (n = 407) who answered incorrectly and 6% (n = 102) who did not provide a response or stated they did not know. Correct responses were numerically higher among white respondents (73%) compared with black (62%) and other (62%) respondents as well as among persons aged < 60 years (73%) vs those aged > 60 years (67%).

Respondents aged between 51 and 64 years were asked how often the average person should receive colon cancer screenings. The most common response was that screening should occur every 5 years (33%) followed by every 10 years (26%). This aligns with the U.S. Preventive Services Task Force’s recommendations for flexible sigmoidoscopy every 5 years or colonoscopy every 10 years.

Eligible respondents were asked to identify reasons they did not seek CRC screening. Eighty-six percent of respondents indicated that they typically scheduled CRC screening and that the question was not applicable. Among respondents who provided an open-ended response, 26% cited feeling uncomfortable with the procedure, 15% cited forgetting to schedule a screening, 15% noted a lack of information on screening, and 11% reported no need for screening (Table 2). Among the 1,734 respondents, 80% reported that they would prefer a fecal occult blood test (FOBT) over either a colonoscopy or a sigmoidoscopy. Only 51% reported that their PCM had previously discussed the different types of CRC screenings at some point.

Discussion

The purpose of this large, representative survey was to obtain information on beneficiaries’ knowledge, perceived barriers, and beliefs regarding breast, cervical, and colorectal cancer screenings to identify factors contributing to low completion rates. As far as is known, this is the first study to address these questions in a TRICARE population. Overall, the findings suggest that beneficiaries consider cancer screening important, largely relying on their PCM or their research to better understand how and when to obtain such screenings. The majority received 1 or more screenings prior to the survey, but there were some common knowledge gaps about how to schedule screening appointments, relevant TRICARE medical benefits, and the current recommendations regarding screening timing and frequency. A commonly reported issue across all surveyed groups was inconvenient screening times.

More than half (55%) of respondents correctly noted that breast cancer screening begins at age 40 years (based on recommendations at the time the survey was conducted), and 72% understood when screening should occur. Despite access to care, inconvenient schedules and testing locations were considered the biggest barriers to regularly obtaining a mammogram. There are few studies on knowledge of breast cancer screening in an insured population available for comparison.^7-10 One study of medically insured black and non-Hispanic women aged 43 to 49 years showed that lack of reminders or knowledge about the need for mammograms, cost, being too busy, and forgetting to schedule appointments were all factors associated with nonadherence to repeat mammography examinations.⁸ In an integrative review published in 2000, authors cited that among 8 of 13 relevant studies, the major barrier to receiving a recommended mammogram was lack of physician recommendation.⁷

For cervical cancer screening, few respondents (1%) correctly identified the age for initiation of screening, and just 12% correctly identified the frequency of screening. These findings are consistent with those of other studies, suggesting a general misunderstanding
about Pap tests in the U.S. and among low-income women.^11,12 Reported barriers to screening were uncommon but included scheduling conflicts and lack of reminders or information and were consistent with barriers cited in prior studies.^13,14 A few respondents (13%) noted that they did not believe in annual screening, which is similar to the findings of Decker and colleagues who cited lack of knowledge about the test and belief that screening is of no benefit as reasons for failure to get a recommended Pap test.¹³ These findings suggest a need to improve patientprovider communication and to provide more patient educational materials about the importance of cervical cancer screening.

A large proportion (71%) gave the correct response regarding the appropriate age to initiate CRC screening. Discomfort with the procedure, belief that the screening is unnecessary, or lack of physician’s recommendation were noted barriers to CRC screening. These findings are similar to those reported elsewhere in non-TRICARE populations.^15-20 Two focus groups included participants with little knowledge about CRC screening, such as risk factors and symptoms, and expressed fear and embarrassment about CRC and screening. Few of the focus group participants were aware of the available options for screening, and some were confused about the purpose and benefits of the various screening modalities.¹⁶

A Health Information National Trends survey reported that 24% participants had not received a colonoscopy or a sigmoidoscopy because their PCM did not order it or say that it was necessary.¹⁵ The reported perceived barriers included fear of an adverse finding, injury to the colon from screening, and embarrassment. A study performed in 1,901 Medicare-insured individuals with no history of CRC cited lack of knowledge/awareness and no physician order as the most common reasons for not undergoing CRC screening.¹⁸

Strengths and Limitations

A major strength of the current survey is the 56% completion rate, which far exceeds other survey participation rates that were as low as 9%.²¹ A second strength is the scope of the survey to capture information on not 1 but 3 different cancer screening practices in a unique population who receive preventive screenings at low to no cost.

There are a few study limitations. The majority of respondents identified as white (80%), which does not fully align with the racial distribution of the TRICARE Prime population in the West Region, which is about 68% white. This higher proportion of white respondents may affect the ability to generalize findings to other populations. However, given the open access to care, race should not be a major factor contributing to screening decisions. Another potential limitation to the generalizability of the study is that the age of the respondents was capped at 64 years. Considering that some of the reported barriers to screening were “too busy” or “scheduling conflict,” a study population that included respondents aged ≥ 65 years (who might be more likely to be retired) might report lower rates of these schedule-related barriers.

A third limitation is that most questions about prior screenings pertained to any time in the past, and, therefore, limited the ability to identify current factors leading to lower screening rates. Last, the survey was developed prior to the 2012 changes in cervical and breast cancer screening recommendations and was therefore scored based on prior recommendations. Given that the goal was to assess knowledge and barriers, results are not expected to differ greatly if they are scored using the newer guidelines.

Conclusion

Findings from this cross-sectional survey indicate high levels of knowledge among TRICARE West Region beneficiaries regarding when and how often screening for breast cancer, cervical cancer, and CRC should occur. To encourage TRICARE beneficiaries to seek and obtain recommended and covered cancer screenings, further efforts are needed, including more education about the importance of screening and how to obtain screening. The survey results suggest that TRICARE Prime beneficiaries view cancer screening as important for overall health but they require (and also may desire) more frequent scheduling reminders, education, and more options for scheduling. Newer modalities for communicating with beneficiaries, such as automated telephone appointment reminders, reminder texts, online appointment scheduling, educational blogs, podcasts on cancer screening, extended appointment hours, or unconventional strategies to bundle screening services, are tools that could be used by providers to achieve greater compliance with cancer screening recommendations.

Author Disclosure
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

Click here to read the digital edition.

The National Defense Appropriations Act for fiscal year 2009, Subtitle B, waived copayments for preventive cancer screening services for all TRICARE beneficiaries, excluding Medicare-eligible beneficiaries.¹ These preventive services include screening for colorectal cancer (CRC), breast cancer, and cervical cancer based on current guidelines (eAppendix1).

Despite having unrestricted access to these cancer screenings, TRICARE Prime beneficiaries report overall screening completion rates that are below the national commercial benchmarks established by the Healthcare Effectiveness Data and Information Set (HEDIS) for all 3 cancer types.² Specifically, among TRICARE Prime beneficiaries enrolled in the western region of the U.S. in October 2013, the reported breast cancer screening rate was 61.6% (43,138/69,976) for women aged 42 to 69 years, which is well below the HEDIS 75th percentile of 76%. Similarly, the reported rate of cervical cancer screening among women aged 24 to 64 years was 68.3% (63,523/92,946), well below the HEDIS 75th percentile of 79%. Last, the reported rate of CRC screening among male and female TRICARE Prime members aged 51 to 75 years was 61.6% (52,860/85,827), also below the 2013 HEDIS 75th percentile of 63% based on internal review of TRICARE data used for HEDIS reporting.

Given the reported low screening rates, the Defense Health Agency (DHA) performed a cross-sectional survey to assess TRICARE Prime West region beneficiaries’ knowledge and understanding of preventive health screening, specifically for breast cancer, cervical cancer, and CRC, and to identify any potential barriers to access for these screenings.

Methods

A mostly closed-ended, 42-item telephone survey was designed and conducted (eAppendix2)

All women participating in the survey, regardless of age, were asked questions regarding cervical cancer screening. Women aged ≥ 42 years additionally were asked a second set of survey questions specific to breast cancer screening, and women aged between 51 and 64 years were asked a third set of questions related to CRC screening. The ages selected were 1 to 2 years after the recommended age for the respective screening to ensure adequate follow-up time for the member to obtain the screening. Men included in the survey were asked questions related only to CRC screening.

The target survey sample was 3,500 beneficiaries, separated into the following 4 strata: women aged 21 to 64 years of age enrolled in the direct care system (n = 1,250); women aged 21 to 64 years enrolled in the purchased (commercial) care network (n = 1,250); men aged 51 to 64 years enrolled in the direct care system (n = 500); and men aged 51 to 64 years enrolled in the purchased care network (n = 500). The random sample was drawn from an overall population of about 35,000 members. Sampling was performed without replacement until the target number of surveys was achieved. Survey completion was defined as the respondent having reached the end of the survey questionnaire but not necessarily having answered every question.

Data Elements

The preventive health survey collected information on beneficiaries’ knowledge of and satisfaction with their PCM, the primary location where they sought health care in the previous 12 months, preference for scheduling cancer screening tests, and general knowledge about the frequency and type of screening for breast, cervical, and colorectal cancers. Responses were scored based on guidelines effective as of 2009. In addition, the survey collected information on the beneficiary’s overall health status, current age, highest level of education achieved, current employment status, place of residence (on or off a military installation), race, and whether the beneficiary carried other health insurance aside from TRICARE.

Survey Mode and Fielding

A sampling population of eligible beneficiaries was created from a database of all TRICARE Prime beneficiaries. An automated system was used to randomly draw potential participants from the sample. Survey interviewers were given the beneficiary’s name and telephone number but no other identifiable information. Phone numbers from the sample were dialed up to 6 times before the number was classified as a “no answer.” Interviewers read to each beneficiary a statement describing the survey and participation risk and benefits and explained that participation was voluntary and the participant could end the survey at any time without penalty or prejudice. The survey commenced only after verbal consent was obtained.

Sample Weighting and Statistical Analysis

Each survey record was weighted to control for potential bias associated with unequal rates of noncoverage and nonresponse in the sampled population. A design weight was calculated as the ratio of the frame size and the sample size in each stratum. For each stratum, an adjusted response rate (RR) was calculated as the number of completed surveys divided by the number of eligible respondents. Since all respondents were eligible, the RR was not adjusted. The ratio of the design weight to the adjusted RR was calculated and assigned to each survey.

Frequency distributions and descriptive statistics were calculated for all close-ended survey items. Open-ended survey items were summarized and assessed qualitatively. When appropriate, open-ended responses were categorized and included in descriptive analyses. No formal statistical testing was performed.

Results

A total of 6,563 beneficiaries were contacted, and 3,688 agreed to participate (56%), resulting in 3,500 TRICARE beneficiaries completing the survey (95% completion rate), of whom 71% (2,500) were female. The overall cooperation rates were similar across the 4 strata. Interviews ceased once 3,500 surveys were completed. The largest distribution of respondents was aged between 55 and 64 years (37%) (Table 1). Respondents aged 21 to 24 years comprised the smallest percentage of the sample (7%). Nearly a third of respondents were dependents of ADSMs (30%), another 30% were retirees, and most respondents self-identified as white (Table 1).

Barriers to Screening

A series of survey questions was asked about specific barriers to cancer screening, including the convenience of appointment times for the respondent’s last cancer screening. The majority (69%, 2,415 of 3,500) responded that the appointment times were convenient. Among those who stated that times were not convenient and those who had not scheduled an examination, 66% responded that they did not know or were not sure how to schedule a cancer screening test.

Screening Preferences

Less than half of survey respondents (48%) reported that they received screening guideline information from their physician or provider; 24% reported that they performed their own research. Only 9% reported that they learned about the guidelines through TRICARE materials, and 7% of respondents indicated that media, family, or friends were their source of screening information.

The survey respondents who indicated that they had not scheduled a screening examination were asked when (time of day) they preferred to have a screening. Less than half (47%) reported that varying available appointment times would not affect their ability to obtain screening. One-quarter preferred times for screening during working hours, 20% preferred times after working hours, 6% preferred times before working hours, and 2% responded that they were unsure or did not know. The majority (89%) reported that they would prefer to receive all available screenings on the same day if possible.

Breast Cancer Screening

Nearly all (98%) of the 1,100 women aged between 42 and 64 years reported having received a mammogram. These women were asked a specific subset of questions related to breast cancer screening. Respondents were asked to state the recommended age at which women should begin receiving mammogram screenings. More than half (55%) provided the correct response (40 years old, per the U.S. Preventive Services Task Force guidelines).^3,4 About three-quarters of respondents (789) correctly responded annually to the question regarding how often women should receive mammograms.

The survey also sought to identify barriers that prevented women from obtaining necessary breast cancer screening. However, the majority surveyed (85%) noted that the question was not applicable because they typically scheduled screening appointments. Only a few (3%) reported factors such as either themselves or someone they know having had a negative experience, discomfort, pain, or concerns of a falsepositive result as reasons for not obtaining breast cancer screening. Of the 112 respondents to the open-ended question, 25% reported that their schedules prevented them from scheduling a mammogram in the past; 12% reported that an inconvenient clinic location, appointment time, or process prevented them from receiving a screening; and 13% reported forgetting to schedule the screening (Table 2).

Cervical Cancer Screening

Female respondents aged between 21 and 64 years (n = 2,432) were asked about the recommended age at which women should begin receiving cervical cancer screening. Only 1% of respondents provided the correct response (that screening begins at 21 years of age per the U.S. Preventive Services Task Force Report guidelines), while 88% provided an incorrect response, and 11% were unsure or did not provide any response.⁵ Among all respondents, 98% reported having had a cervical cancer screening.

Respondents were asked how frequently women should have a Papanicolaou (Pap) test. Responses such as “2 to 3 years,” “2 years,” or “every other year” were labeled as correct, whereas responses such as “every 6 months” or “greater than 3 years” were labeled as incorrect. Just 12% of respondents provided a correct response, whereas 86% answered incorrectly, and 2% did not answer or did not know. Of those who answered incorrectly, the most common response was “annually” or “every year,” with no notable differences according to race, age, or beneficiary category.

To better understand barriers to screening, respondents were asked to identify reasons they might not have sought cervical cancer screening. The majority (84%) reported that they typically scheduled appointments and that the question was not applicable. However, among 228 respondents who provided an open-ended response and who had not previously undergone a hysterectomy, 8% stated that they had received no reminder or that they lacked sufficient information to schedule the appointment, 21% forgot to schedule, 18% reported a scheduling conflict or difficulty in receiving care, and 13% noted that they did not believe in annual screening (Table 2).

Colorectal Cancer Screening

Eighty-seven percent of eligible respondents (n = 1,734) reported having ever had a sigmoidoscopy and/or colonoscopy. Respondents were asked for their understanding of the recommended age for men and women to begin CRC screening.6 Nearly three-quarters of respondents provided a correct response (n = 1,225), compared with 23% of respondents (n = 407) who answered incorrectly and 6% (n = 102) who did not provide a response or stated they did not know. Correct responses were numerically higher among white respondents (73%) compared with black (62%) and other (62%) respondents as well as among persons aged < 60 years (73%) vs those aged > 60 years (67%).

Respondents aged between 51 and 64 years were asked how often the average person should receive colon cancer screenings. The most common response was that screening should occur every 5 years (33%) followed by every 10 years (26%). This aligns with the U.S. Preventive Services Task Force’s recommendations for flexible sigmoidoscopy every 5 years or colonoscopy every 10 years.

Eligible respondents were asked to identify reasons they did not seek CRC screening. Eighty-six percent of respondents indicated that they typically scheduled CRC screening and that the question was not applicable. Among respondents who provided an open-ended response, 26% cited feeling uncomfortable with the procedure, 15% cited forgetting to schedule a screening, 15% noted a lack of information on screening, and 11% reported no need for screening (Table 2). Among the 1,734 respondents, 80% reported that they would prefer a fecal occult blood test (FOBT) over either a colonoscopy or a sigmoidoscopy. Only 51% reported that their PCM had previously discussed the different types of CRC screenings at some point.

Discussion

The purpose of this large, representative survey was to obtain information on beneficiaries’ knowledge, perceived barriers, and beliefs regarding breast, cervical, and colorectal cancer screenings to identify factors contributing to low completion rates. As far as is known, this is the first study to address these questions in a TRICARE population. Overall, the findings suggest that beneficiaries consider cancer screening important, largely relying on their PCM or their research to better understand how and when to obtain such screenings. The majority received 1 or more screenings prior to the survey, but there were some common knowledge gaps about how to schedule screening appointments, relevant TRICARE medical benefits, and the current recommendations regarding screening timing and frequency. A commonly reported issue across all surveyed groups was inconvenient screening times.

More than half (55%) of respondents correctly noted that breast cancer screening begins at age 40 years (based on recommendations at the time the survey was conducted), and 72% understood when screening should occur. Despite access to care, inconvenient schedules and testing locations were considered the biggest barriers to regularly obtaining a mammogram. There are few studies on knowledge of breast cancer screening in an insured population available for comparison.^7-10 One study of medically insured black and non-Hispanic women aged 43 to 49 years showed that lack of reminders or knowledge about the need for mammograms, cost, being too busy, and forgetting to schedule appointments were all factors associated with nonadherence to repeat mammography examinations.⁸ In an integrative review published in 2000, authors cited that among 8 of 13 relevant studies, the major barrier to receiving a recommended mammogram was lack of physician recommendation.⁷

For cervical cancer screening, few respondents (1%) correctly identified the age for initiation of screening, and just 12% correctly identified the frequency of screening. These findings are consistent with those of other studies, suggesting a general misunderstanding
about Pap tests in the U.S. and among low-income women.^11,12 Reported barriers to screening were uncommon but included scheduling conflicts and lack of reminders or information and were consistent with barriers cited in prior studies.^13,14 A few respondents (13%) noted that they did not believe in annual screening, which is similar to the findings of Decker and colleagues who cited lack of knowledge about the test and belief that screening is of no benefit as reasons for failure to get a recommended Pap test.¹³ These findings suggest a need to improve patientprovider communication and to provide more patient educational materials about the importance of cervical cancer screening.

A large proportion (71%) gave the correct response regarding the appropriate age to initiate CRC screening. Discomfort with the procedure, belief that the screening is unnecessary, or lack of physician’s recommendation were noted barriers to CRC screening. These findings are similar to those reported elsewhere in non-TRICARE populations.^15-20 Two focus groups included participants with little knowledge about CRC screening, such as risk factors and symptoms, and expressed fear and embarrassment about CRC and screening. Few of the focus group participants were aware of the available options for screening, and some were confused about the purpose and benefits of the various screening modalities.¹⁶

A Health Information National Trends survey reported that 24% participants had not received a colonoscopy or a sigmoidoscopy because their PCM did not order it or say that it was necessary.¹⁵ The reported perceived barriers included fear of an adverse finding, injury to the colon from screening, and embarrassment. A study performed in 1,901 Medicare-insured individuals with no history of CRC cited lack of knowledge/awareness and no physician order as the most common reasons for not undergoing CRC screening.¹⁸

Strengths and Limitations

A major strength of the current survey is the 56% completion rate, which far exceeds other survey participation rates that were as low as 9%.²¹ A second strength is the scope of the survey to capture information on not 1 but 3 different cancer screening practices in a unique population who receive preventive screenings at low to no cost.

There are a few study limitations. The majority of respondents identified as white (80%), which does not fully align with the racial distribution of the TRICARE Prime population in the West Region, which is about 68% white. This higher proportion of white respondents may affect the ability to generalize findings to other populations. However, given the open access to care, race should not be a major factor contributing to screening decisions. Another potential limitation to the generalizability of the study is that the age of the respondents was capped at 64 years. Considering that some of the reported barriers to screening were “too busy” or “scheduling conflict,” a study population that included respondents aged ≥ 65 years (who might be more likely to be retired) might report lower rates of these schedule-related barriers.

A third limitation is that most questions about prior screenings pertained to any time in the past, and, therefore, limited the ability to identify current factors leading to lower screening rates. Last, the survey was developed prior to the 2012 changes in cervical and breast cancer screening recommendations and was therefore scored based on prior recommendations. Given that the goal was to assess knowledge and barriers, results are not expected to differ greatly if they are scored using the newer guidelines.

Conclusion

Findings from this cross-sectional survey indicate high levels of knowledge among TRICARE West Region beneficiaries regarding when and how often screening for breast cancer, cervical cancer, and CRC should occur. To encourage TRICARE beneficiaries to seek and obtain recommended and covered cancer screenings, further efforts are needed, including more education about the importance of screening and how to obtain screening. The survey results suggest that TRICARE Prime beneficiaries view cancer screening as important for overall health but they require (and also may desire) more frequent scheduling reminders, education, and more options for scheduling. Newer modalities for communicating with beneficiaries, such as automated telephone appointment reminders, reminder texts, online appointment scheduling, educational blogs, podcasts on cancer screening, extended appointment hours, or unconventional strategies to bundle screening services, are tools that could be used by providers to achieve greater compliance with cancer screening recommendations.

Author Disclosure
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

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Follicular lymphoma

The US Food and Drug Administration (FDA) has granted 2 fast track designations to 5F9, an anti-CD47 antibody.

The designations are for 5F9 as a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).

Data supporting the fast track designations were derived from a phase 1b/2 trial of 5F9 in combination with rituximab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including DLBCL and FL.

Forty Seven, Inc., the company developing 5F9, expects to announce initial safety and efficacy data from the phase 1b portion of the trial in the second quarter of 2018.

About fast track designation

The FDA’s fast track drug development program is designed to expedite clinical development and submission of applications for drugs with the potential to treat serious or life-threatening conditions and address unmet medical needs.

Fast track designation facilitates frequent interactions with the FDA review team, including meetings to discuss the drug’s development plan and written communications about issues such as trial design and use of biomarkers.

Drugs that receive fast track designation may be eligible for accelerated approval and priority review if relevant criteria are met.

Fast track drugs may also be eligible for rolling review, which allows a developer to submit individual sections of a drug’s application for review as they are ready, rather than waiting until all sections are complete.

Follicular lymphoma

The US Food and Drug Administration (FDA) has granted 2 fast track designations to 5F9, an anti-CD47 antibody.

The designations are for 5F9 as a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).

Data supporting the fast track designations were derived from a phase 1b/2 trial of 5F9 in combination with rituximab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including DLBCL and FL.

Forty Seven, Inc., the company developing 5F9, expects to announce initial safety and efficacy data from the phase 1b portion of the trial in the second quarter of 2018.

About fast track designation

The FDA’s fast track drug development program is designed to expedite clinical development and submission of applications for drugs with the potential to treat serious or life-threatening conditions and address unmet medical needs.

Fast track designation facilitates frequent interactions with the FDA review team, including meetings to discuss the drug’s development plan and written communications about issues such as trial design and use of biomarkers.

Drugs that receive fast track designation may be eligible for accelerated approval and priority review if relevant criteria are met.

Fast track drugs may also be eligible for rolling review, which allows a developer to submit individual sections of a drug’s application for review as they are ready, rather than waiting until all sections are complete.

Follicular lymphoma

The US Food and Drug Administration (FDA) has granted 2 fast track designations to 5F9, an anti-CD47 antibody.

The designations are for 5F9 as a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).

Data supporting the fast track designations were derived from a phase 1b/2 trial of 5F9 in combination with rituximab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including DLBCL and FL.

Forty Seven, Inc., the company developing 5F9, expects to announce initial safety and efficacy data from the phase 1b portion of the trial in the second quarter of 2018.

About fast track designation

The FDA’s fast track drug development program is designed to expedite clinical development and submission of applications for drugs with the potential to treat serious or life-threatening conditions and address unmet medical needs.

Fast track designation facilitates frequent interactions with the FDA review team, including meetings to discuss the drug’s development plan and written communications about issues such as trial design and use of biomarkers.

Drugs that receive fast track designation may be eligible for accelerated approval and priority review if relevant criteria are met.

Fast track drugs may also be eligible for rolling review, which allows a developer to submit individual sections of a drug’s application for review as they are ready, rather than waiting until all sections are complete.

TORONTO – Children with asthma who have a comorbid diagnosis of anxiety or depression are significantly more likely to make asthma-related visits to the emergency department, compared with their peers who do not have a mental health condition, results from a large administrative data analysis showed.

“There has been a fair bit of research on how comorbid mental health conditions can affect health care utilization for asthma in adults, but few studies have examined how comorbid mental health conditions like anxiety or depression can affect children with asthma,” one of the study authors, Caroline Neel, said in an interview in advance of the Pediatric Academic Societies meeting.

[email protected]

TORONTO – Children with asthma who have a comorbid diagnosis of anxiety or depression are significantly more likely to make asthma-related visits to the emergency department, compared with their peers who do not have a mental health condition, results from a large administrative data analysis showed.

“There has been a fair bit of research on how comorbid mental health conditions can affect health care utilization for asthma in adults, but few studies have examined how comorbid mental health conditions like anxiety or depression can affect children with asthma,” one of the study authors, Caroline Neel, said in an interview in advance of the Pediatric Academic Societies meeting.

[email protected]

TORONTO – Children with asthma who have a comorbid diagnosis of anxiety or depression are significantly more likely to make asthma-related visits to the emergency department, compared with their peers who do not have a mental health condition, results from a large administrative data analysis showed.

“There has been a fair bit of research on how comorbid mental health conditions can affect health care utilization for asthma in adults, but few studies have examined how comorbid mental health conditions like anxiety or depression can affect children with asthma,” one of the study authors, Caroline Neel, said in an interview in advance of the Pediatric Academic Societies meeting.

[email protected]

The American College of Physicians and the American College of Obstetricians and Gynecologists expressed concern over possible significant changes to Title X, a long-standing federal program that provides gynecologic care and family planning information and services, primarily to low-income and uninsured Americans.

“An announcement is expected any day that the Trump administration is going to make dramatic changes to Title X funding,” said Shari M. Erickson, vice president of governmental affairs and medical practice at the American College of Physicians, during a joint telebriefing May 4.

[email protected]

The American College of Physicians and the American College of Obstetricians and Gynecologists expressed concern over possible significant changes to Title X, a long-standing federal program that provides gynecologic care and family planning information and services, primarily to low-income and uninsured Americans.

“An announcement is expected any day that the Trump administration is going to make dramatic changes to Title X funding,” said Shari M. Erickson, vice president of governmental affairs and medical practice at the American College of Physicians, during a joint telebriefing May 4.

[email protected]

The American College of Physicians and the American College of Obstetricians and Gynecologists expressed concern over possible significant changes to Title X, a long-standing federal program that provides gynecologic care and family planning information and services, primarily to low-income and uninsured Americans.

“An announcement is expected any day that the Trump administration is going to make dramatic changes to Title X funding,” said Shari M. Erickson, vice president of governmental affairs and medical practice at the American College of Physicians, during a joint telebriefing May 4.

[email protected]

ABSTRACT

Outcome instruments have become an essential part of the evaluation of functional recovery after anterior cruciate ligament (ACL) reconstruction. Although the clinical examination provides important objective information to assess graft integrity, stability, range of motion, and strength, these measurements do not take the patient’s perception into account. There are many knee outcome instruments, and it is challenging for surgeons to understand how to interpret clinical research and utilize these measures in a practical way. The purpose of this review is to provide an overview of the most commonly used outcome measures in patients undergoing ACL reconstruction and to examine and compare the psychometric performance (validity, reliability, responsiveness) of these measurement tools.

Anterior cruciate ligament (ACL) reconstruction is one of the most common elective orthopedic procedures.¹ Despite advances in surgical techniques, ACL reconstruction is associated with a lengthy recovery time, decreased performance, and increased rate of reinjury.² Patients undergoing ACL reconstruction are often active individuals who participate in demanding activities, and accurate assessment of their recovery helps to guide recovery counseling. In addition to objective clinical outcomes measured through physical examination, patient-reported outcome (PRO) instruments add the patient’s perspective, information critical in determining a successful outcome. A variety of outcome instruments have been used and validated for patients with ACL tears. It is important for orthopedic surgeons to know the advantages and disadvantages of each outcome tool in order to interpret clinical studies and assess postoperative patients.

Over the last 10 years, there has been an increase in the number of knee instruments and rating scales designed to measure PROs, with >54 scores designed for the ACL-deficient knee.³ No standardized instrument is currently universally accepted as superior following ACL reconstruction across the spectrum of patient populations. Clinicians and researchers must carefully consider an outcome instrument’s utility based on specific patient populations in which it has been evaluated. Appropriate selection of outcome measures is of fundamental importance for adequate demonstration of the efficacy and value of treatment interventions, especially in an era of healthcare reform with a focus on providing high-quality and cost-effective care.

The purpose of this review is to highlight current tools used to measure outcomes after ACL reconstruction. Current outcome measures vary widely in regards to their validity, reliability, minimal clinically important difference, and applicability to specific patient populations. We have thus identified the measures most commonly used today in studies and clinical follow-up after ACL reconstruction and their various advantages and limitations. This information may enhance the orthopedic surgeon’s understanding of what outcome measures may be utilized in clinical studies.

Continue to: Patient-Reported Outcome Instruments...

PATIENT-REPORTED OUTCOME INSTRUMENTS

Recently, there has been a transition to increased use of PRO instruments rather than clinician-based postoperative assessment, largely due to the increasing emphasis on patient satisfaction in determining the value of an orthopedic intervention.⁴ PRO instruments are widely used to capture the patient’s perception of general health, quality of life (QOL), daily function, and pain. PRO instruments offer the benefit of allowing patients to subjectively assess their knee function during daily living and sports activities, conveying to the provider the impact of ACL reconstruction on physical, psychological, and social aspects of everyday activities. Furthermore, patient satisfaction has been shown to closely follow outcome scores related to symptoms and function.⁵ A multitude of specific knee-related PRO instruments have been developed and validated to measure outcomes after ACL reconstruction for both research and clinical purposes (Table).

Table. ACL Outcome Measures

Abbreviations: AAOS, American Academy of Orthopaedic Surgeons; ACL, anterior cruciate ligament; ACL-QOL, anterior cruciate ligament quality of life score; CAT, computer-adapting testing; IKDC, International Knee Documentation Committee; KOOS, Knee Injury and Osteoarthritis Outcome Score; OA, osteoarthritis; PF, physical function; PROMIS, Patient-Reported Outcome Measurement Information System; Ref, references; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.

MEASUREMENT PROPERTIES

In general, clinicians and investigators should use health-related outcome measures with established reliability, validity, patient relevance, and responsiveness for assessing the specific condition.⁶

Reliability refers to the degree to which a measurement score is free from random error, reflecting how consistent or reproducible the instrument is when administered under the same testing conditions. Internal consistency, test-retest reliability, and measurement error are measures of reliability. Internal consistency is tested after a single administration and assesses how well items within a scale measure a single underlying dimension, represented using item-total correlation coefficients and Cronbach’s alpha. A Cronbach’s alpha of 0.70 to 0.95 is generally defined as good.⁷ Test-retest reliability is designed to appraise variation over time in stable patients and is represented using the intraclass correlation coefficient (ICC).⁸ An ICC >0.7 is considered acceptable; >0.8, good; and >0.9, excellent.⁹ An aspect of accuracy is whether the scoring system measures the full range of the disease or complaints. The incidence of minimum (floor) and maximum (ceiling) scores can be calculated for outcome scores. An instrument with low floor and ceiling effects, below 10% to 15%, is more inconclusive and can be more reliably used to measure patients at the high and low end of the scoring system.¹⁰

Validity is the ability of an outcome instrument to measure what it is intended to measure. Establishing validity is complex and requires evaluation of several facets, including content validity, construct validity, and criterion validity. Content validity is a relatively subjective judgment explaining the ability of an instrument to assess the critical features of the problem. Construct validity evaluates whether the questionnaire measures what it intends to measure, and is often assessed by correlating scores form one instrument to those from other proven instruments that are already accepted as valid. Finally, criterion validity assesses the correlation between the score and a previously established “gold standard” instrument.

Responsiveness is the ability of the instrument to detect a change or identify improvement or worsening of a clinical condition over time. Most frequently, the effect size (observed change/standard deviation of baseline scores) and standardized response mean (observed change/standard deviation of change) are used as measures of responsiveness. The minimal clinically important difference of an outcome measure is the smallest change in an outcome score that corresponds to a change in patient condition.

Continue to: ACL Outcome Instruments...

ACL OUTCOME INSTRUMENTS

WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX (WOMAC LK 3.0)

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC LK 3.0) was developed in 1982 and is a widely used, disease-specific instrument recommended for the evaluation of treatment effects in patients with hip and knee osteoarthritis.¹¹ Available in more than 80 languages, it is a self-administered, generic health status questionnaire developed to assess pain, function, and stiffness in daily living, taking respondents between 3 to 7.5 minutes for completion.¹² Using visual analog scales, the 24 items probe the 3 subscales: pain (5 items), stiffness (2 items), and functional difficulty (17 items). Scores are calculated for each dimension, and the total score is normalized to a 100-point scale, with 0 indicating severe symptoms and 100 indicating no symptoms and higher function. The WOMAC score can also be calculated from the Knee Injury and Osteoarthritis Outcome Score (KOOS). The WOMAC questionnaire is well recognized for its good validity, reliability, and responsiveness, and is the most commonly used outcome measure for osteoarthritis.^13-15 Considering its focus on older patients with osteoarthritis, it may not be appropriate for use in a young and active population.

KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS)

The KOOS is a knee-specific questionnaire developed as an extension of the WOMAC to evaluate the functional status and QOL of patients with any type of knee injury who are at an increased risk of developing osteoarthritis.¹⁶ The patient-based questionnaire is available in over 30 languages and covers both the short- and long-term consequences of an injury of the knee causing traumatic damage to cartilage, ligaments, and menisci. The KOOS is 42 items graded on a 5-point Likert scale, covering 5 subscales: pain (9 items), symptoms (7 items), function in activities of daily living (17 items), function in sports/recreation (5 items), and knee-related QOL (4 items). The questionnaire is self-administered and takes about 10 minutes to complete. Scores are calculated for each dimension, and the total score is transformed to a 0 to 100 scale, with 0 representing severe knee problems and 100 representing no knee problems and better outcome. An advantage of the KOOS is that it evaluates both knee injuries and osteoarthritis; therefore, it is arguably more suitable for evaluating patients over the long-term. The KOOS has been validated for several orthopedic interventions, including ACL reconstruction and rehabilitation^16,17 as well as meniscectomy¹⁸ and total knee replacement.¹⁹ Population-based reference data for the adult population according to age and gender have also been established.²⁰ The KOOS is increasingly utilized in clinical studies on ACL reconstruction.^21-25 The questions of the WOMAC were retained so that a WOMAC score might be calculated separately and compared with the KOOS score.²⁶

PATIENT-REPORTED OUTCOMES INFORMATION SYSTEM (PROMIS)

Since 2004, The National Institutes of Health (NIH) has funded the development of the Patient-Reported Outcome Measurement Information System (PROMIS), a set of flexible tools that reliably and validly measure PROs. The PROMIS consists of a library of question banks that has been developed and operated by a network of National Institutes of Health-funded research sites and coordinating centers and covers many different health domains including pain, fatigue, anxiety, depression, social functioning, physical functioning, and sleep. PROMIS items are developed using Item Response Theory (IRT), wherein the answer to any individual item has a known mathematical probability of predicting the test taker’s overall measurement of the specific trait being tested. This is commonly administered using computer-adaptive testing (CAT), which presents to the test taker an initial item, scores the response to that item, and from the response then presents the most informative second item, and so forth until a predefined level of precision is reached. Because the items are individually validated, they can be used alone or in any combination, a feature that distinguishes the PROMIS from traditional fixed-length PRO instruments that require the completion of an instrument in its entirety to be valid.²⁷ In recent years, orthopedic research has been published with PROMIS physical function (PF) scores as primary outcome measures.^28-30 The PF item bank includes 124 items measuring upper extremity, lower extremity, central and instrumental activities of daily living. PF can be completed as a short form (SF) with a set number of questions or utilizing CAT and evaluates self-reported function and physical activity. An advantage is its ease of use and potential to minimize test burden with very few questions, often as little as 4 items, as compared to other traditional PROMs.³¹

Previously published work has demonstrated that, in patients undergoing meniscal surgery, the PROMIS PF CAT maintains construct validity and correlates well with currently used knee outcome instruments, including KOOS.²⁸ Work by the same group looking at the performance of the PROMIS PF CAT in patients indicated for ACL reconstruction shows that the PROMIS PF CAT correlates well with other PRO instruments for patients with ACL injuries, (SF-36 PF [r = 0.82, P < 0.01], KOOS Sport [r = 0.70, P < 0.01], KOOS ADL [r = 0.74, P < 0.01]), does not have floor or ceiling effects in this relatively young and healthy population, and has a low test burden.^32,33 Papuga and colleagues³³ also compared the International Knee Documentation Committee (IKDC) and PROMIS PF CAT on 106 subjects after ACL reconstruction and found good correlation.

Continue to: Quality of Life Outcome Measure...

QUALITY OF LIFE OUTCOME MEASURE FOR ACL DEFICIENCY (ACL-QOL)

The ACL-QOL Score was developed in 1998 as a disease-specific measure for patients with chronic ACL deficiency.³⁴ This scale consists of 32 separate items in 31 visual analog questions regarding symptoms and physical complaints, work-related concerns, recreational activities and sport participation or competition, lifestyle, and social and emotional health status relating to the knee. The raw score is transformed into a 0- to 100-point scale, with higher scores indicating a better outcome. The scale is valid, reliable, and responsive for patients with ACL insufficiency,^35,36 and is not applicable to other disorders of the knee. We recommend the ACL-QOL questionnaire be used in conjunction with other currently available objective and functional outcome measures.

CINCINNATI KNEE RATING SYSTEM

The Cincinnati Knee Rating System (CKRS) was first described in 1983 and was modified to include occupational activities, athletic activities, symptoms, and functional limitations.^37,38 There are 11 components, measuring symptoms and disability in sports activity, activities of daily living function, occupational rating, as well as sections that measure physical examination, laxity of the knee, and radiographic evidence of degenerative joint disease.³⁹ The measure is scored on a 100-point scale, with higher scores indicating better outcomes. Scores have been shown to be lower as compared with other outcome measures assessing the same clinical condition.^40,41 Barber-Westin and colleagues³⁹ confirmed the reliability, validity, and responsiveness of the CKRS by testing 350 subjects with and without knee ligament injuries. In 2001, Marx⁴² tested the CKRS subjective form for reliability, validity, and responsiveness and found it to be acceptable for clinical research.

LYSHOLM KNEE SCORE

The Lysholm Knee Score was published in 1982 and modified in 1985, consisting of an 8-question survey that evaluates outcomes after knee ligament surgery. Items include pain, instability, locking, squatting, limping, support usage, swelling, and stair-climbing ability, with pain and instability carrying the highest weight.⁴³ It is scored on a scale of 0 to 100, with high scores indicating higher functioning and fewer symptoms. It has been validated in patients with ACL injuries and meniscal injuries.⁴⁴ Although it is widely used to measure outcomes after ACL reconstruction,⁴⁵ it has received criticism in the evaluation of patients with other knee conditions.⁴⁶ The main advantage of the Lysholm Knee Score is its ability to note changes in activity in the same patient across different time periods (responsiveness). A limitation of the Lysholm Knee Score is that it does not measure the domains of functioning in daily activities, sports, and recreational activities. The Lysholm scoring system’s test-retest reliability and construct validity have been evaluated,^42,43,46 although there has been some concern regarding a ceiling effect and its validity, sensitivity, and reliability has been questioned.⁴⁷ Therefore, it is advised that this score be used in conjunction with other PRO scores.

INTERNATIONAL KNEE DOCUMENTATION COMMITTEE (IKDC) SUBJECTIVE KNEE FORM

In 1987, members of the European Society for Knee Surgery and Arthroscopy and the American Orthopaedic Society for Sports Medicine formed the IKDC to develop a standardized method for evaluating knee injuries and treatment. The IKDC Subjective Knee Evaluation Form was initially published in 1993, and in 2001 the form was revised by the American Orthopaedic Society for Sports Medicine to become a knee-specific assessment tool rather than a disease or condition-specific tool.⁴⁸ The IKDC subjective form is an 18-question, knee-specific survey designed to detect improvement or deterioration in symptoms, function, and ability to participate in sports activities experienced by patients following knee surgery or other interventions. The individual items are summed and transformed into a 0- to 100-point scale, with high scores representing higher levels of function and minimal symptoms. The IKDC is utilized to assess a variety of knee conditions including ligament, meniscus, articular cartilage, osteoarthritis, and patellofemoral pain.^48,49 Thus, this form can be used to assess any condition involving the knee and allow comparison between groups with different diagnoses. The IKDC has been validated for an ACL reconstruction population,⁴⁷ has been used to assess outcomes in recent clinical studies on ACL reconstruction,^50,51 and is one of the most frequently used measures for patients with ACL deficiency.³ The validity, responsiveness, and reliability of the IKDC subjective form has been confirmed for both adult and adolescent populations.^48,49,52-54

TEGNER ACTIVITY SCORES

The Tegner activity score was developed in 1985 and was designed to provide an objective value for a patient’s activity level.⁴⁴ This scale was developed to complement the Lysholm score. It consists of 1 sport-specific activity level question on a 0 to 10 scale that evaluates an individual’s ability to compete in a sporting activity. Scores between 1 and 5 represent work or recreational sports. Scores >5 represent higher-level recreational and competitive sports. The Tegner activity score is one of the most widely used activity scoring systems for patients with knee disorders,^55,56 commonly utilized with the Lysholm Knee Score.⁴⁴ One disadvantage of the Tegner activity score is that it relates to specific sports rather than functional activities, which limits its generalizability. We are not aware of any studies documenting the reliability or validity of this instrument.

Continue on: Marx Activity Rating Scale...

MARX ACTIVITY RATING SCALE

The Marx activity rating scale was developed to be utilized with other knee rating scales and outcome measures as an activity assessment.⁵⁷ In contrast to the Tegner activity score, the Marx activity rating scale measures function rather than sport-specific activity. The scale is a short, patient-based activity assessment that consists of a 4-question survey evaluating patients’ knee health by recording the frequency and intensity of participation in a sporting activity. Questions are scored from 0 to 4 on the basis of how often the activity is performed. The 4 sections of the Marx scale that are rated include running, cutting, decelerating, and pivoting. This scale has been validated in patients with ACL injuries, chondromalacia patellae, and meniscal lesions.^42,56-58 Acceptable ceiling effects of 3% and floor effects of 8% were noted in the study of ACL-injured patients.⁵⁷

AMERICAN ACADEMY OF ORTHOPAEDIC SURGEONS (AAOS) SPORTS KNEE SCALE

The American Academy of Orthopaedic Surgeons (AAOS) Sports Knee Rating Scale consists of 5 parts and 23 items, including a section addressing stiffness, swelling, pain and function (7 questions), locking/catching (4 questions), giving way (4 questions), limitations of activity (4 questions), and pain with activity (4 questions).^59,60 Items may be dropped if patients select particular responses, which can lead to difficulties when using the survey. This scoring system has been found to be satisfactory when all subscales were combined and the mean was calculated.⁴²

DISCUSSION

PRO measures play an increasingly important role in the measurement of success and impact of health care services. Specifically, for ACL reconstruction, patient satisfaction is key for demonstrating the value of operative or other interventions. Selecting a suitable outcome measurement tool can be daunting, as it can be difficult to ascertain which outcome measures are appropriate for the patient or disorder in question. As there is currently no instrument that is universally superior in the evaluation of ACL outcomes, clinicians must consider the specific patient population in which the outcome instrument has been evaluated. Investigators should also use instruments with reported minimal clinically important differences so that variation in scores can be interpreted as either clinically significant or not. When choosing which outcome instrument to use, there is rarely a single appropriate rating system that is entirely comprehensive. In most cases, a general health outcome measure should be used in combination with a condition-specific rating scale. Activity rating scales, such as Marx or Tegner, should be included, especially when evaluating patients with low-activity lifestyles.

CONCLUSION

There are a number of reliable, valid, and responsive outcome measures that can be utilized to evaluate outcomes following ACL reconstruction in an array of patient populations. Outcome measures should be relevant to patients, easy to use, reliable, valid, and responsive to change. By increasing familiarity with these outcome measures, orthopedic surgeons and investigators can develop better studies, interpret data, and implement findings in practice with sound and informed judgment. Future research should focus on identifying the most relevant outcome metrics for assessing function following ACL reconstruction.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

Outcome instruments have become an essential part of the evaluation of functional recovery after anterior cruciate ligament (ACL) reconstruction. Although the clinical examination provides important objective information to assess graft integrity, stability, range of motion, and strength, these measurements do not take the patient’s perception into account. There are many knee outcome instruments, and it is challenging for surgeons to understand how to interpret clinical research and utilize these measures in a practical way. The purpose of this review is to provide an overview of the most commonly used outcome measures in patients undergoing ACL reconstruction and to examine and compare the psychometric performance (validity, reliability, responsiveness) of these measurement tools.

Anterior cruciate ligament (ACL) reconstruction is one of the most common elective orthopedic procedures.¹ Despite advances in surgical techniques, ACL reconstruction is associated with a lengthy recovery time, decreased performance, and increased rate of reinjury.² Patients undergoing ACL reconstruction are often active individuals who participate in demanding activities, and accurate assessment of their recovery helps to guide recovery counseling. In addition to objective clinical outcomes measured through physical examination, patient-reported outcome (PRO) instruments add the patient’s perspective, information critical in determining a successful outcome. A variety of outcome instruments have been used and validated for patients with ACL tears. It is important for orthopedic surgeons to know the advantages and disadvantages of each outcome tool in order to interpret clinical studies and assess postoperative patients.

Over the last 10 years, there has been an increase in the number of knee instruments and rating scales designed to measure PROs, with >54 scores designed for the ACL-deficient knee.³ No standardized instrument is currently universally accepted as superior following ACL reconstruction across the spectrum of patient populations. Clinicians and researchers must carefully consider an outcome instrument’s utility based on specific patient populations in which it has been evaluated. Appropriate selection of outcome measures is of fundamental importance for adequate demonstration of the efficacy and value of treatment interventions, especially in an era of healthcare reform with a focus on providing high-quality and cost-effective care.

The purpose of this review is to highlight current tools used to measure outcomes after ACL reconstruction. Current outcome measures vary widely in regards to their validity, reliability, minimal clinically important difference, and applicability to specific patient populations. We have thus identified the measures most commonly used today in studies and clinical follow-up after ACL reconstruction and their various advantages and limitations. This information may enhance the orthopedic surgeon’s understanding of what outcome measures may be utilized in clinical studies.

Continue to: Patient-Reported Outcome Instruments...

PATIENT-REPORTED OUTCOME INSTRUMENTS

Recently, there has been a transition to increased use of PRO instruments rather than clinician-based postoperative assessment, largely due to the increasing emphasis on patient satisfaction in determining the value of an orthopedic intervention.⁴ PRO instruments are widely used to capture the patient’s perception of general health, quality of life (QOL), daily function, and pain. PRO instruments offer the benefit of allowing patients to subjectively assess their knee function during daily living and sports activities, conveying to the provider the impact of ACL reconstruction on physical, psychological, and social aspects of everyday activities. Furthermore, patient satisfaction has been shown to closely follow outcome scores related to symptoms and function.⁵ A multitude of specific knee-related PRO instruments have been developed and validated to measure outcomes after ACL reconstruction for both research and clinical purposes (Table).

Table. ACL Outcome Measures

Abbreviations: AAOS, American Academy of Orthopaedic Surgeons; ACL, anterior cruciate ligament; ACL-QOL, anterior cruciate ligament quality of life score; CAT, computer-adapting testing; IKDC, International Knee Documentation Committee; KOOS, Knee Injury and Osteoarthritis Outcome Score; OA, osteoarthritis; PF, physical function; PROMIS, Patient-Reported Outcome Measurement Information System; Ref, references; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.

MEASUREMENT PROPERTIES

In general, clinicians and investigators should use health-related outcome measures with established reliability, validity, patient relevance, and responsiveness for assessing the specific condition.⁶

Reliability refers to the degree to which a measurement score is free from random error, reflecting how consistent or reproducible the instrument is when administered under the same testing conditions. Internal consistency, test-retest reliability, and measurement error are measures of reliability. Internal consistency is tested after a single administration and assesses how well items within a scale measure a single underlying dimension, represented using item-total correlation coefficients and Cronbach’s alpha. A Cronbach’s alpha of 0.70 to 0.95 is generally defined as good.⁷ Test-retest reliability is designed to appraise variation over time in stable patients and is represented using the intraclass correlation coefficient (ICC).⁸ An ICC >0.7 is considered acceptable; >0.8, good; and >0.9, excellent.⁹ An aspect of accuracy is whether the scoring system measures the full range of the disease or complaints. The incidence of minimum (floor) and maximum (ceiling) scores can be calculated for outcome scores. An instrument with low floor and ceiling effects, below 10% to 15%, is more inconclusive and can be more reliably used to measure patients at the high and low end of the scoring system.¹⁰

Validity is the ability of an outcome instrument to measure what it is intended to measure. Establishing validity is complex and requires evaluation of several facets, including content validity, construct validity, and criterion validity. Content validity is a relatively subjective judgment explaining the ability of an instrument to assess the critical features of the problem. Construct validity evaluates whether the questionnaire measures what it intends to measure, and is often assessed by correlating scores form one instrument to those from other proven instruments that are already accepted as valid. Finally, criterion validity assesses the correlation between the score and a previously established “gold standard” instrument.

Responsiveness is the ability of the instrument to detect a change or identify improvement or worsening of a clinical condition over time. Most frequently, the effect size (observed change/standard deviation of baseline scores) and standardized response mean (observed change/standard deviation of change) are used as measures of responsiveness. The minimal clinically important difference of an outcome measure is the smallest change in an outcome score that corresponds to a change in patient condition.

Continue to: ACL Outcome Instruments...

ACL OUTCOME INSTRUMENTS

WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX (WOMAC LK 3.0)

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC LK 3.0) was developed in 1982 and is a widely used, disease-specific instrument recommended for the evaluation of treatment effects in patients with hip and knee osteoarthritis.¹¹ Available in more than 80 languages, it is a self-administered, generic health status questionnaire developed to assess pain, function, and stiffness in daily living, taking respondents between 3 to 7.5 minutes for completion.¹² Using visual analog scales, the 24 items probe the 3 subscales: pain (5 items), stiffness (2 items), and functional difficulty (17 items). Scores are calculated for each dimension, and the total score is normalized to a 100-point scale, with 0 indicating severe symptoms and 100 indicating no symptoms and higher function. The WOMAC score can also be calculated from the Knee Injury and Osteoarthritis Outcome Score (KOOS). The WOMAC questionnaire is well recognized for its good validity, reliability, and responsiveness, and is the most commonly used outcome measure for osteoarthritis.^13-15 Considering its focus on older patients with osteoarthritis, it may not be appropriate for use in a young and active population.

KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS)

The KOOS is a knee-specific questionnaire developed as an extension of the WOMAC to evaluate the functional status and QOL of patients with any type of knee injury who are at an increased risk of developing osteoarthritis.¹⁶ The patient-based questionnaire is available in over 30 languages and covers both the short- and long-term consequences of an injury of the knee causing traumatic damage to cartilage, ligaments, and menisci. The KOOS is 42 items graded on a 5-point Likert scale, covering 5 subscales: pain (9 items), symptoms (7 items), function in activities of daily living (17 items), function in sports/recreation (5 items), and knee-related QOL (4 items). The questionnaire is self-administered and takes about 10 minutes to complete. Scores are calculated for each dimension, and the total score is transformed to a 0 to 100 scale, with 0 representing severe knee problems and 100 representing no knee problems and better outcome. An advantage of the KOOS is that it evaluates both knee injuries and osteoarthritis; therefore, it is arguably more suitable for evaluating patients over the long-term. The KOOS has been validated for several orthopedic interventions, including ACL reconstruction and rehabilitation^16,17 as well as meniscectomy¹⁸ and total knee replacement.¹⁹ Population-based reference data for the adult population according to age and gender have also been established.²⁰ The KOOS is increasingly utilized in clinical studies on ACL reconstruction.^21-25 The questions of the WOMAC were retained so that a WOMAC score might be calculated separately and compared with the KOOS score.²⁶

PATIENT-REPORTED OUTCOMES INFORMATION SYSTEM (PROMIS)

Since 2004, The National Institutes of Health (NIH) has funded the development of the Patient-Reported Outcome Measurement Information System (PROMIS), a set of flexible tools that reliably and validly measure PROs. The PROMIS consists of a library of question banks that has been developed and operated by a network of National Institutes of Health-funded research sites and coordinating centers and covers many different health domains including pain, fatigue, anxiety, depression, social functioning, physical functioning, and sleep. PROMIS items are developed using Item Response Theory (IRT), wherein the answer to any individual item has a known mathematical probability of predicting the test taker’s overall measurement of the specific trait being tested. This is commonly administered using computer-adaptive testing (CAT), which presents to the test taker an initial item, scores the response to that item, and from the response then presents the most informative second item, and so forth until a predefined level of precision is reached. Because the items are individually validated, they can be used alone or in any combination, a feature that distinguishes the PROMIS from traditional fixed-length PRO instruments that require the completion of an instrument in its entirety to be valid.²⁷ In recent years, orthopedic research has been published with PROMIS physical function (PF) scores as primary outcome measures.^28-30 The PF item bank includes 124 items measuring upper extremity, lower extremity, central and instrumental activities of daily living. PF can be completed as a short form (SF) with a set number of questions or utilizing CAT and evaluates self-reported function and physical activity. An advantage is its ease of use and potential to minimize test burden with very few questions, often as little as 4 items, as compared to other traditional PROMs.³¹

Previously published work has demonstrated that, in patients undergoing meniscal surgery, the PROMIS PF CAT maintains construct validity and correlates well with currently used knee outcome instruments, including KOOS.²⁸ Work by the same group looking at the performance of the PROMIS PF CAT in patients indicated for ACL reconstruction shows that the PROMIS PF CAT correlates well with other PRO instruments for patients with ACL injuries, (SF-36 PF [r = 0.82, P < 0.01], KOOS Sport [r = 0.70, P < 0.01], KOOS ADL [r = 0.74, P < 0.01]), does not have floor or ceiling effects in this relatively young and healthy population, and has a low test burden.^32,33 Papuga and colleagues³³ also compared the International Knee Documentation Committee (IKDC) and PROMIS PF CAT on 106 subjects after ACL reconstruction and found good correlation.

Continue to: Quality of Life Outcome Measure...

QUALITY OF LIFE OUTCOME MEASURE FOR ACL DEFICIENCY (ACL-QOL)

The ACL-QOL Score was developed in 1998 as a disease-specific measure for patients with chronic ACL deficiency.³⁴ This scale consists of 32 separate items in 31 visual analog questions regarding symptoms and physical complaints, work-related concerns, recreational activities and sport participation or competition, lifestyle, and social and emotional health status relating to the knee. The raw score is transformed into a 0- to 100-point scale, with higher scores indicating a better outcome. The scale is valid, reliable, and responsive for patients with ACL insufficiency,^35,36 and is not applicable to other disorders of the knee. We recommend the ACL-QOL questionnaire be used in conjunction with other currently available objective and functional outcome measures.

CINCINNATI KNEE RATING SYSTEM

The Cincinnati Knee Rating System (CKRS) was first described in 1983 and was modified to include occupational activities, athletic activities, symptoms, and functional limitations.^37,38 There are 11 components, measuring symptoms and disability in sports activity, activities of daily living function, occupational rating, as well as sections that measure physical examination, laxity of the knee, and radiographic evidence of degenerative joint disease.³⁹ The measure is scored on a 100-point scale, with higher scores indicating better outcomes. Scores have been shown to be lower as compared with other outcome measures assessing the same clinical condition.^40,41 Barber-Westin and colleagues³⁹ confirmed the reliability, validity, and responsiveness of the CKRS by testing 350 subjects with and without knee ligament injuries. In 2001, Marx⁴² tested the CKRS subjective form for reliability, validity, and responsiveness and found it to be acceptable for clinical research.

LYSHOLM KNEE SCORE

The Lysholm Knee Score was published in 1982 and modified in 1985, consisting of an 8-question survey that evaluates outcomes after knee ligament surgery. Items include pain, instability, locking, squatting, limping, support usage, swelling, and stair-climbing ability, with pain and instability carrying the highest weight.⁴³ It is scored on a scale of 0 to 100, with high scores indicating higher functioning and fewer symptoms. It has been validated in patients with ACL injuries and meniscal injuries.⁴⁴ Although it is widely used to measure outcomes after ACL reconstruction,⁴⁵ it has received criticism in the evaluation of patients with other knee conditions.⁴⁶ The main advantage of the Lysholm Knee Score is its ability to note changes in activity in the same patient across different time periods (responsiveness). A limitation of the Lysholm Knee Score is that it does not measure the domains of functioning in daily activities, sports, and recreational activities. The Lysholm scoring system’s test-retest reliability and construct validity have been evaluated,^42,43,46 although there has been some concern regarding a ceiling effect and its validity, sensitivity, and reliability has been questioned.⁴⁷ Therefore, it is advised that this score be used in conjunction with other PRO scores.

INTERNATIONAL KNEE DOCUMENTATION COMMITTEE (IKDC) SUBJECTIVE KNEE FORM

In 1987, members of the European Society for Knee Surgery and Arthroscopy and the American Orthopaedic Society for Sports Medicine formed the IKDC to develop a standardized method for evaluating knee injuries and treatment. The IKDC Subjective Knee Evaluation Form was initially published in 1993, and in 2001 the form was revised by the American Orthopaedic Society for Sports Medicine to become a knee-specific assessment tool rather than a disease or condition-specific tool.⁴⁸ The IKDC subjective form is an 18-question, knee-specific survey designed to detect improvement or deterioration in symptoms, function, and ability to participate in sports activities experienced by patients following knee surgery or other interventions. The individual items are summed and transformed into a 0- to 100-point scale, with high scores representing higher levels of function and minimal symptoms. The IKDC is utilized to assess a variety of knee conditions including ligament, meniscus, articular cartilage, osteoarthritis, and patellofemoral pain.^48,49 Thus, this form can be used to assess any condition involving the knee and allow comparison between groups with different diagnoses. The IKDC has been validated for an ACL reconstruction population,⁴⁷ has been used to assess outcomes in recent clinical studies on ACL reconstruction,^50,51 and is one of the most frequently used measures for patients with ACL deficiency.³ The validity, responsiveness, and reliability of the IKDC subjective form has been confirmed for both adult and adolescent populations.^48,49,52-54

TEGNER ACTIVITY SCORES

The Tegner activity score was developed in 1985 and was designed to provide an objective value for a patient’s activity level.⁴⁴ This scale was developed to complement the Lysholm score. It consists of 1 sport-specific activity level question on a 0 to 10 scale that evaluates an individual’s ability to compete in a sporting activity. Scores between 1 and 5 represent work or recreational sports. Scores >5 represent higher-level recreational and competitive sports. The Tegner activity score is one of the most widely used activity scoring systems for patients with knee disorders,^55,56 commonly utilized with the Lysholm Knee Score.⁴⁴ One disadvantage of the Tegner activity score is that it relates to specific sports rather than functional activities, which limits its generalizability. We are not aware of any studies documenting the reliability or validity of this instrument.

Continue on: Marx Activity Rating Scale...

MARX ACTIVITY RATING SCALE

The Marx activity rating scale was developed to be utilized with other knee rating scales and outcome measures as an activity assessment.⁵⁷ In contrast to the Tegner activity score, the Marx activity rating scale measures function rather than sport-specific activity. The scale is a short, patient-based activity assessment that consists of a 4-question survey evaluating patients’ knee health by recording the frequency and intensity of participation in a sporting activity. Questions are scored from 0 to 4 on the basis of how often the activity is performed. The 4 sections of the Marx scale that are rated include running, cutting, decelerating, and pivoting. This scale has been validated in patients with ACL injuries, chondromalacia patellae, and meniscal lesions.^42,56-58 Acceptable ceiling effects of 3% and floor effects of 8% were noted in the study of ACL-injured patients.⁵⁷

AMERICAN ACADEMY OF ORTHOPAEDIC SURGEONS (AAOS) SPORTS KNEE SCALE

The American Academy of Orthopaedic Surgeons (AAOS) Sports Knee Rating Scale consists of 5 parts and 23 items, including a section addressing stiffness, swelling, pain and function (7 questions), locking/catching (4 questions), giving way (4 questions), limitations of activity (4 questions), and pain with activity (4 questions).^59,60 Items may be dropped if patients select particular responses, which can lead to difficulties when using the survey. This scoring system has been found to be satisfactory when all subscales were combined and the mean was calculated.⁴²

DISCUSSION

PRO measures play an increasingly important role in the measurement of success and impact of health care services. Specifically, for ACL reconstruction, patient satisfaction is key for demonstrating the value of operative or other interventions. Selecting a suitable outcome measurement tool can be daunting, as it can be difficult to ascertain which outcome measures are appropriate for the patient or disorder in question. As there is currently no instrument that is universally superior in the evaluation of ACL outcomes, clinicians must consider the specific patient population in which the outcome instrument has been evaluated. Investigators should also use instruments with reported minimal clinically important differences so that variation in scores can be interpreted as either clinically significant or not. When choosing which outcome instrument to use, there is rarely a single appropriate rating system that is entirely comprehensive. In most cases, a general health outcome measure should be used in combination with a condition-specific rating scale. Activity rating scales, such as Marx or Tegner, should be included, especially when evaluating patients with low-activity lifestyles.

CONCLUSION

There are a number of reliable, valid, and responsive outcome measures that can be utilized to evaluate outcomes following ACL reconstruction in an array of patient populations. Outcome measures should be relevant to patients, easy to use, reliable, valid, and responsive to change. By increasing familiarity with these outcome measures, orthopedic surgeons and investigators can develop better studies, interpret data, and implement findings in practice with sound and informed judgment. Future research should focus on identifying the most relevant outcome metrics for assessing function following ACL reconstruction.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

Outcome instruments have become an essential part of the evaluation of functional recovery after anterior cruciate ligament (ACL) reconstruction. Although the clinical examination provides important objective information to assess graft integrity, stability, range of motion, and strength, these measurements do not take the patient’s perception into account. There are many knee outcome instruments, and it is challenging for surgeons to understand how to interpret clinical research and utilize these measures in a practical way. The purpose of this review is to provide an overview of the most commonly used outcome measures in patients undergoing ACL reconstruction and to examine and compare the psychometric performance (validity, reliability, responsiveness) of these measurement tools.

Anterior cruciate ligament (ACL) reconstruction is one of the most common elective orthopedic procedures.¹ Despite advances in surgical techniques, ACL reconstruction is associated with a lengthy recovery time, decreased performance, and increased rate of reinjury.² Patients undergoing ACL reconstruction are often active individuals who participate in demanding activities, and accurate assessment of their recovery helps to guide recovery counseling. In addition to objective clinical outcomes measured through physical examination, patient-reported outcome (PRO) instruments add the patient’s perspective, information critical in determining a successful outcome. A variety of outcome instruments have been used and validated for patients with ACL tears. It is important for orthopedic surgeons to know the advantages and disadvantages of each outcome tool in order to interpret clinical studies and assess postoperative patients.

Over the last 10 years, there has been an increase in the number of knee instruments and rating scales designed to measure PROs, with >54 scores designed for the ACL-deficient knee.³ No standardized instrument is currently universally accepted as superior following ACL reconstruction across the spectrum of patient populations. Clinicians and researchers must carefully consider an outcome instrument’s utility based on specific patient populations in which it has been evaluated. Appropriate selection of outcome measures is of fundamental importance for adequate demonstration of the efficacy and value of treatment interventions, especially in an era of healthcare reform with a focus on providing high-quality and cost-effective care.

The purpose of this review is to highlight current tools used to measure outcomes after ACL reconstruction. Current outcome measures vary widely in regards to their validity, reliability, minimal clinically important difference, and applicability to specific patient populations. We have thus identified the measures most commonly used today in studies and clinical follow-up after ACL reconstruction and their various advantages and limitations. This information may enhance the orthopedic surgeon’s understanding of what outcome measures may be utilized in clinical studies.

Continue to: Patient-Reported Outcome Instruments...

PATIENT-REPORTED OUTCOME INSTRUMENTS

Recently, there has been a transition to increased use of PRO instruments rather than clinician-based postoperative assessment, largely due to the increasing emphasis on patient satisfaction in determining the value of an orthopedic intervention.⁴ PRO instruments are widely used to capture the patient’s perception of general health, quality of life (QOL), daily function, and pain. PRO instruments offer the benefit of allowing patients to subjectively assess their knee function during daily living and sports activities, conveying to the provider the impact of ACL reconstruction on physical, psychological, and social aspects of everyday activities. Furthermore, patient satisfaction has been shown to closely follow outcome scores related to symptoms and function.⁵ A multitude of specific knee-related PRO instruments have been developed and validated to measure outcomes after ACL reconstruction for both research and clinical purposes (Table).

Table. ACL Outcome Measures

Abbreviations: AAOS, American Academy of Orthopaedic Surgeons; ACL, anterior cruciate ligament; ACL-QOL, anterior cruciate ligament quality of life score; CAT, computer-adapting testing; IKDC, International Knee Documentation Committee; KOOS, Knee Injury and Osteoarthritis Outcome Score; OA, osteoarthritis; PF, physical function; PROMIS, Patient-Reported Outcome Measurement Information System; Ref, references; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.

MEASUREMENT PROPERTIES

In general, clinicians and investigators should use health-related outcome measures with established reliability, validity, patient relevance, and responsiveness for assessing the specific condition.⁶

Reliability refers to the degree to which a measurement score is free from random error, reflecting how consistent or reproducible the instrument is when administered under the same testing conditions. Internal consistency, test-retest reliability, and measurement error are measures of reliability. Internal consistency is tested after a single administration and assesses how well items within a scale measure a single underlying dimension, represented using item-total correlation coefficients and Cronbach’s alpha. A Cronbach’s alpha of 0.70 to 0.95 is generally defined as good.⁷ Test-retest reliability is designed to appraise variation over time in stable patients and is represented using the intraclass correlation coefficient (ICC).⁸ An ICC >0.7 is considered acceptable; >0.8, good; and >0.9, excellent.⁹ An aspect of accuracy is whether the scoring system measures the full range of the disease or complaints. The incidence of minimum (floor) and maximum (ceiling) scores can be calculated for outcome scores. An instrument with low floor and ceiling effects, below 10% to 15%, is more inconclusive and can be more reliably used to measure patients at the high and low end of the scoring system.¹⁰

Validity is the ability of an outcome instrument to measure what it is intended to measure. Establishing validity is complex and requires evaluation of several facets, including content validity, construct validity, and criterion validity. Content validity is a relatively subjective judgment explaining the ability of an instrument to assess the critical features of the problem. Construct validity evaluates whether the questionnaire measures what it intends to measure, and is often assessed by correlating scores form one instrument to those from other proven instruments that are already accepted as valid. Finally, criterion validity assesses the correlation between the score and a previously established “gold standard” instrument.

Responsiveness is the ability of the instrument to detect a change or identify improvement or worsening of a clinical condition over time. Most frequently, the effect size (observed change/standard deviation of baseline scores) and standardized response mean (observed change/standard deviation of change) are used as measures of responsiveness. The minimal clinically important difference of an outcome measure is the smallest change in an outcome score that corresponds to a change in patient condition.

Continue to: ACL Outcome Instruments...

ACL OUTCOME INSTRUMENTS

WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX (WOMAC LK 3.0)

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC LK 3.0) was developed in 1982 and is a widely used, disease-specific instrument recommended for the evaluation of treatment effects in patients with hip and knee osteoarthritis.¹¹ Available in more than 80 languages, it is a self-administered, generic health status questionnaire developed to assess pain, function, and stiffness in daily living, taking respondents between 3 to 7.5 minutes for completion.¹² Using visual analog scales, the 24 items probe the 3 subscales: pain (5 items), stiffness (2 items), and functional difficulty (17 items). Scores are calculated for each dimension, and the total score is normalized to a 100-point scale, with 0 indicating severe symptoms and 100 indicating no symptoms and higher function. The WOMAC score can also be calculated from the Knee Injury and Osteoarthritis Outcome Score (KOOS). The WOMAC questionnaire is well recognized for its good validity, reliability, and responsiveness, and is the most commonly used outcome measure for osteoarthritis.^13-15 Considering its focus on older patients with osteoarthritis, it may not be appropriate for use in a young and active population.

KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS)

The KOOS is a knee-specific questionnaire developed as an extension of the WOMAC to evaluate the functional status and QOL of patients with any type of knee injury who are at an increased risk of developing osteoarthritis.¹⁶ The patient-based questionnaire is available in over 30 languages and covers both the short- and long-term consequences of an injury of the knee causing traumatic damage to cartilage, ligaments, and menisci. The KOOS is 42 items graded on a 5-point Likert scale, covering 5 subscales: pain (9 items), symptoms (7 items), function in activities of daily living (17 items), function in sports/recreation (5 items), and knee-related QOL (4 items). The questionnaire is self-administered and takes about 10 minutes to complete. Scores are calculated for each dimension, and the total score is transformed to a 0 to 100 scale, with 0 representing severe knee problems and 100 representing no knee problems and better outcome. An advantage of the KOOS is that it evaluates both knee injuries and osteoarthritis; therefore, it is arguably more suitable for evaluating patients over the long-term. The KOOS has been validated for several orthopedic interventions, including ACL reconstruction and rehabilitation^16,17 as well as meniscectomy¹⁸ and total knee replacement.¹⁹ Population-based reference data for the adult population according to age and gender have also been established.²⁰ The KOOS is increasingly utilized in clinical studies on ACL reconstruction.^21-25 The questions of the WOMAC were retained so that a WOMAC score might be calculated separately and compared with the KOOS score.²⁶

PATIENT-REPORTED OUTCOMES INFORMATION SYSTEM (PROMIS)

Since 2004, The National Institutes of Health (NIH) has funded the development of the Patient-Reported Outcome Measurement Information System (PROMIS), a set of flexible tools that reliably and validly measure PROs. The PROMIS consists of a library of question banks that has been developed and operated by a network of National Institutes of Health-funded research sites and coordinating centers and covers many different health domains including pain, fatigue, anxiety, depression, social functioning, physical functioning, and sleep. PROMIS items are developed using Item Response Theory (IRT), wherein the answer to any individual item has a known mathematical probability of predicting the test taker’s overall measurement of the specific trait being tested. This is commonly administered using computer-adaptive testing (CAT), which presents to the test taker an initial item, scores the response to that item, and from the response then presents the most informative second item, and so forth until a predefined level of precision is reached. Because the items are individually validated, they can be used alone or in any combination, a feature that distinguishes the PROMIS from traditional fixed-length PRO instruments that require the completion of an instrument in its entirety to be valid.²⁷ In recent years, orthopedic research has been published with PROMIS physical function (PF) scores as primary outcome measures.^28-30 The PF item bank includes 124 items measuring upper extremity, lower extremity, central and instrumental activities of daily living. PF can be completed as a short form (SF) with a set number of questions or utilizing CAT and evaluates self-reported function and physical activity. An advantage is its ease of use and potential to minimize test burden with very few questions, often as little as 4 items, as compared to other traditional PROMs.³¹

Previously published work has demonstrated that, in patients undergoing meniscal surgery, the PROMIS PF CAT maintains construct validity and correlates well with currently used knee outcome instruments, including KOOS.²⁸ Work by the same group looking at the performance of the PROMIS PF CAT in patients indicated for ACL reconstruction shows that the PROMIS PF CAT correlates well with other PRO instruments for patients with ACL injuries, (SF-36 PF [r = 0.82, P < 0.01], KOOS Sport [r = 0.70, P < 0.01], KOOS ADL [r = 0.74, P < 0.01]), does not have floor or ceiling effects in this relatively young and healthy population, and has a low test burden.^32,33 Papuga and colleagues³³ also compared the International Knee Documentation Committee (IKDC) and PROMIS PF CAT on 106 subjects after ACL reconstruction and found good correlation.

Continue to: Quality of Life Outcome Measure...

QUALITY OF LIFE OUTCOME MEASURE FOR ACL DEFICIENCY (ACL-QOL)

The ACL-QOL Score was developed in 1998 as a disease-specific measure for patients with chronic ACL deficiency.³⁴ This scale consists of 32 separate items in 31 visual analog questions regarding symptoms and physical complaints, work-related concerns, recreational activities and sport participation or competition, lifestyle, and social and emotional health status relating to the knee. The raw score is transformed into a 0- to 100-point scale, with higher scores indicating a better outcome. The scale is valid, reliable, and responsive for patients with ACL insufficiency,^35,36 and is not applicable to other disorders of the knee. We recommend the ACL-QOL questionnaire be used in conjunction with other currently available objective and functional outcome measures.

CINCINNATI KNEE RATING SYSTEM

The Cincinnati Knee Rating System (CKRS) was first described in 1983 and was modified to include occupational activities, athletic activities, symptoms, and functional limitations.^37,38 There are 11 components, measuring symptoms and disability in sports activity, activities of daily living function, occupational rating, as well as sections that measure physical examination, laxity of the knee, and radiographic evidence of degenerative joint disease.³⁹ The measure is scored on a 100-point scale, with higher scores indicating better outcomes. Scores have been shown to be lower as compared with other outcome measures assessing the same clinical condition.^40,41 Barber-Westin and colleagues³⁹ confirmed the reliability, validity, and responsiveness of the CKRS by testing 350 subjects with and without knee ligament injuries. In 2001, Marx⁴² tested the CKRS subjective form for reliability, validity, and responsiveness and found it to be acceptable for clinical research.

LYSHOLM KNEE SCORE

The Lysholm Knee Score was published in 1982 and modified in 1985, consisting of an 8-question survey that evaluates outcomes after knee ligament surgery. Items include pain, instability, locking, squatting, limping, support usage, swelling, and stair-climbing ability, with pain and instability carrying the highest weight.⁴³ It is scored on a scale of 0 to 100, with high scores indicating higher functioning and fewer symptoms. It has been validated in patients with ACL injuries and meniscal injuries.⁴⁴ Although it is widely used to measure outcomes after ACL reconstruction,⁴⁵ it has received criticism in the evaluation of patients with other knee conditions.⁴⁶ The main advantage of the Lysholm Knee Score is its ability to note changes in activity in the same patient across different time periods (responsiveness). A limitation of the Lysholm Knee Score is that it does not measure the domains of functioning in daily activities, sports, and recreational activities. The Lysholm scoring system’s test-retest reliability and construct validity have been evaluated,^42,43,46 although there has been some concern regarding a ceiling effect and its validity, sensitivity, and reliability has been questioned.⁴⁷ Therefore, it is advised that this score be used in conjunction with other PRO scores.

INTERNATIONAL KNEE DOCUMENTATION COMMITTEE (IKDC) SUBJECTIVE KNEE FORM

In 1987, members of the European Society for Knee Surgery and Arthroscopy and the American Orthopaedic Society for Sports Medicine formed the IKDC to develop a standardized method for evaluating knee injuries and treatment. The IKDC Subjective Knee Evaluation Form was initially published in 1993, and in 2001 the form was revised by the American Orthopaedic Society for Sports Medicine to become a knee-specific assessment tool rather than a disease or condition-specific tool.⁴⁸ The IKDC subjective form is an 18-question, knee-specific survey designed to detect improvement or deterioration in symptoms, function, and ability to participate in sports activities experienced by patients following knee surgery or other interventions. The individual items are summed and transformed into a 0- to 100-point scale, with high scores representing higher levels of function and minimal symptoms. The IKDC is utilized to assess a variety of knee conditions including ligament, meniscus, articular cartilage, osteoarthritis, and patellofemoral pain.^48,49 Thus, this form can be used to assess any condition involving the knee and allow comparison between groups with different diagnoses. The IKDC has been validated for an ACL reconstruction population,⁴⁷ has been used to assess outcomes in recent clinical studies on ACL reconstruction,^50,51 and is one of the most frequently used measures for patients with ACL deficiency.³ The validity, responsiveness, and reliability of the IKDC subjective form has been confirmed for both adult and adolescent populations.^48,49,52-54

TEGNER ACTIVITY SCORES

The Tegner activity score was developed in 1985 and was designed to provide an objective value for a patient’s activity level.⁴⁴ This scale was developed to complement the Lysholm score. It consists of 1 sport-specific activity level question on a 0 to 10 scale that evaluates an individual’s ability to compete in a sporting activity. Scores between 1 and 5 represent work or recreational sports. Scores >5 represent higher-level recreational and competitive sports. The Tegner activity score is one of the most widely used activity scoring systems for patients with knee disorders,^55,56 commonly utilized with the Lysholm Knee Score.⁴⁴ One disadvantage of the Tegner activity score is that it relates to specific sports rather than functional activities, which limits its generalizability. We are not aware of any studies documenting the reliability or validity of this instrument.

Continue on: Marx Activity Rating Scale...

MARX ACTIVITY RATING SCALE

The Marx activity rating scale was developed to be utilized with other knee rating scales and outcome measures as an activity assessment.⁵⁷ In contrast to the Tegner activity score, the Marx activity rating scale measures function rather than sport-specific activity. The scale is a short, patient-based activity assessment that consists of a 4-question survey evaluating patients’ knee health by recording the frequency and intensity of participation in a sporting activity. Questions are scored from 0 to 4 on the basis of how often the activity is performed. The 4 sections of the Marx scale that are rated include running, cutting, decelerating, and pivoting. This scale has been validated in patients with ACL injuries, chondromalacia patellae, and meniscal lesions.^42,56-58 Acceptable ceiling effects of 3% and floor effects of 8% were noted in the study of ACL-injured patients.⁵⁷

AMERICAN ACADEMY OF ORTHOPAEDIC SURGEONS (AAOS) SPORTS KNEE SCALE

The American Academy of Orthopaedic Surgeons (AAOS) Sports Knee Rating Scale consists of 5 parts and 23 items, including a section addressing stiffness, swelling, pain and function (7 questions), locking/catching (4 questions), giving way (4 questions), limitations of activity (4 questions), and pain with activity (4 questions).^59,60 Items may be dropped if patients select particular responses, which can lead to difficulties when using the survey. This scoring system has been found to be satisfactory when all subscales were combined and the mean was calculated.⁴²

DISCUSSION

PRO measures play an increasingly important role in the measurement of success and impact of health care services. Specifically, for ACL reconstruction, patient satisfaction is key for demonstrating the value of operative or other interventions. Selecting a suitable outcome measurement tool can be daunting, as it can be difficult to ascertain which outcome measures are appropriate for the patient or disorder in question. As there is currently no instrument that is universally superior in the evaluation of ACL outcomes, clinicians must consider the specific patient population in which the outcome instrument has been evaluated. Investigators should also use instruments with reported minimal clinically important differences so that variation in scores can be interpreted as either clinically significant or not. When choosing which outcome instrument to use, there is rarely a single appropriate rating system that is entirely comprehensive. In most cases, a general health outcome measure should be used in combination with a condition-specific rating scale. Activity rating scales, such as Marx or Tegner, should be included, especially when evaluating patients with low-activity lifestyles.

CONCLUSION

There are a number of reliable, valid, and responsive outcome measures that can be utilized to evaluate outcomes following ACL reconstruction in an array of patient populations. Outcome measures should be relevant to patients, easy to use, reliable, valid, and responsive to change. By increasing familiarity with these outcome measures, orthopedic surgeons and investigators can develop better studies, interpret data, and implement findings in practice with sound and informed judgment. Future research should focus on identifying the most relevant outcome metrics for assessing function following ACL reconstruction.

This paper will be judged for the Resident Writer’s Award.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced on May 4 that is sponsoring a phase 2 trial of a universal flu vaccine, M-001. The trial will test the experimental vaccine for safety and its ability to produce potentially broad protective immune responses, both on its own and when followed by a standard seasonal influenza vaccine. It is being conducted at four U.S. sites that are part of the Vaccine and Treatment Evaluation Units, funded by NIAID.

luiscar/Thinkstock

[email protected]

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced on May 4 that is sponsoring a phase 2 trial of a universal flu vaccine, M-001. The trial will test the experimental vaccine for safety and its ability to produce potentially broad protective immune responses, both on its own and when followed by a standard seasonal influenza vaccine. It is being conducted at four U.S. sites that are part of the Vaccine and Treatment Evaluation Units, funded by NIAID.

luiscar/Thinkstock

[email protected]

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced on May 4 that is sponsoring a phase 2 trial of a universal flu vaccine, M-001. The trial will test the experimental vaccine for safety and its ability to produce potentially broad protective immune responses, both on its own and when followed by a standard seasonal influenza vaccine. It is being conducted at four U.S. sites that are part of the Vaccine and Treatment Evaluation Units, funded by NIAID.

luiscar/Thinkstock

[email protected]

WASHINGTON – Using machine learning and data from 2,466 Apache tribal members, researchers developed a formula for predicting suicide attempts among youths aged 15-24 years with a “pretty high” level of accuracy, Emily E. Haroz, PhD, said at the annual conference of the American Association of Suicidology.

The area under the receiver operating characteristic curve for the best performing predictive model was 0.806, said Dr. Haroz, a psychiatric epidemiologist at Johns Hopkins University in Baltimore. This compared with an area under the curve of 0.57 for prediction based solely on prior attempts, which is a “very low” predictive score, Dr. Haroz noted. The area under the curve is a performance measure used widely to make predictions.

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Initial data from questionnaires completed at the end of the elders program showed high levels of enjoyment among the students and high levels of retention of some information. For example, after the elders’ program, 96% could identify their clan, and 96% could say what is sacred about the Apache land, she noted. Further data analysis is in progress, Dr. O’Keefe said, and she and her associates are adapting the elders program for use by other Native communities.

Mitchel L. Zoler/MDedge News

[email protected]

WASHINGTON – Using machine learning and data from 2,466 Apache tribal members, researchers developed a formula for predicting suicide attempts among youths aged 15-24 years with a “pretty high” level of accuracy, Emily E. Haroz, PhD, said at the annual conference of the American Association of Suicidology.

The area under the receiver operating characteristic curve for the best performing predictive model was 0.806, said Dr. Haroz, a psychiatric epidemiologist at Johns Hopkins University in Baltimore. This compared with an area under the curve of 0.57 for prediction based solely on prior attempts, which is a “very low” predictive score, Dr. Haroz noted. The area under the curve is a performance measure used widely to make predictions.

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Initial data from questionnaires completed at the end of the elders program showed high levels of enjoyment among the students and high levels of retention of some information. For example, after the elders’ program, 96% could identify their clan, and 96% could say what is sacred about the Apache land, she noted. Further data analysis is in progress, Dr. O’Keefe said, and she and her associates are adapting the elders program for use by other Native communities.

Mitchel L. Zoler/MDedge News

[email protected]

WASHINGTON – Using machine learning and data from 2,466 Apache tribal members, researchers developed a formula for predicting suicide attempts among youths aged 15-24 years with a “pretty high” level of accuracy, Emily E. Haroz, PhD, said at the annual conference of the American Association of Suicidology.

The area under the receiver operating characteristic curve for the best performing predictive model was 0.806, said Dr. Haroz, a psychiatric epidemiologist at Johns Hopkins University in Baltimore. This compared with an area under the curve of 0.57 for prediction based solely on prior attempts, which is a “very low” predictive score, Dr. Haroz noted. The area under the curve is a performance measure used widely to make predictions.

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Initial data from questionnaires completed at the end of the elders program showed high levels of enjoyment among the students and high levels of retention of some information. For example, after the elders’ program, 96% could identify their clan, and 96% could say what is sacred about the Apache land, she noted. Further data analysis is in progress, Dr. O’Keefe said, and she and her associates are adapting the elders program for use by other Native communities.

Mitchel L. Zoler/MDedge News

[email protected]

In order to identify the prevalence of concerns among postpartum women and the factors associated with them, the University of California–San Francisco (UCSF) began calling all of its obstetric patients through an automated phone call within 72 hours after hospital discharge.

Study details

All postpartum women from March to June 2017 were contacted after discharge via an automated call. Calls were considered successful if the woman engaged with the automated system; those who reported concerns were contacted by a nurse. UCSF researchers compared call success and presence of concerns by mode of delivery, insurance type (public or private), parity, pregnancy complication (diabetes, hypertension, hemorrhage), and neonatal intensive care (ICN) admission using univariate analyses and multivariable logistic regression.

A total of 881 women were called, and 730 (83%) were successfully contacted (meaning they engaged with the automated system through to the end of the call). About one-third of women (224 / 29%) reported a concern. Women with operative vaginal delivery were more likely to report an issue than spontaneous vaginal and cesarean delivery (42% vs 28%; P = .04). Nulliparous women also were more likely to report an issue (32% vs 25%; P = .05). They also were more likely to answer the call (86% vs 79%; P = .004). Women with public insurance were less likely to be successfully contacted (68% vs 84%; P = .003), but the frequency of concerns were equivalent (28% vs 29%). Women with neonates in the ICN were less likely to be successfully contacted. When controlling for confounders, nulliparity (odds ratio [OR], 1.5; 95% confidence interval [CI], 1.1–2.2) and private insurance (OR, 1.9; 95% CI, 1.1–3.8) both were independently associated with successful contact.

What do the results mean for practice?

Nulliparous women and women with operative vaginal deliveries may benefit from additional discharge support, concluded the researchers. “For most patients we can’t predict in advance if they will have an operative vaginal delivery but I do think that we could do more counseling in the antepartum period about different options or mode of delivery and include operative vaginal deliveries in that bucket, especially as we are doing more of them,” said Dr. Molly Siegel, Resident at UCSF. “In the postpartum period we probably should be thinking more about our instructions to those patients because we have cesarean delivery and vaginal delivery discharge instructions, and I think there needs to be something specific for operative vaginal delivery. Ultimately the goal is to improve our counseling of patients so that they don’t have as many questions after they leave the hospital.”

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In order to identify the prevalence of concerns among postpartum women and the factors associated with them, the University of California–San Francisco (UCSF) began calling all of its obstetric patients through an automated phone call within 72 hours after hospital discharge.

Study details

All postpartum women from March to June 2017 were contacted after discharge via an automated call. Calls were considered successful if the woman engaged with the automated system; those who reported concerns were contacted by a nurse. UCSF researchers compared call success and presence of concerns by mode of delivery, insurance type (public or private), parity, pregnancy complication (diabetes, hypertension, hemorrhage), and neonatal intensive care (ICN) admission using univariate analyses and multivariable logistic regression.

A total of 881 women were called, and 730 (83%) were successfully contacted (meaning they engaged with the automated system through to the end of the call). About one-third of women (224 / 29%) reported a concern. Women with operative vaginal delivery were more likely to report an issue than spontaneous vaginal and cesarean delivery (42% vs 28%; P = .04). Nulliparous women also were more likely to report an issue (32% vs 25%; P = .05). They also were more likely to answer the call (86% vs 79%; P = .004). Women with public insurance were less likely to be successfully contacted (68% vs 84%; P = .003), but the frequency of concerns were equivalent (28% vs 29%). Women with neonates in the ICN were less likely to be successfully contacted. When controlling for confounders, nulliparity (odds ratio [OR], 1.5; 95% confidence interval [CI], 1.1–2.2) and private insurance (OR, 1.9; 95% CI, 1.1–3.8) both were independently associated with successful contact.

What do the results mean for practice?

Nulliparous women and women with operative vaginal deliveries may benefit from additional discharge support, concluded the researchers. “For most patients we can’t predict in advance if they will have an operative vaginal delivery but I do think that we could do more counseling in the antepartum period about different options or mode of delivery and include operative vaginal deliveries in that bucket, especially as we are doing more of them,” said Dr. Molly Siegel, Resident at UCSF. “In the postpartum period we probably should be thinking more about our instructions to those patients because we have cesarean delivery and vaginal delivery discharge instructions, and I think there needs to be something specific for operative vaginal delivery. Ultimately the goal is to improve our counseling of patients so that they don’t have as many questions after they leave the hospital.”

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In order to identify the prevalence of concerns among postpartum women and the factors associated with them, the University of California–San Francisco (UCSF) began calling all of its obstetric patients through an automated phone call within 72 hours after hospital discharge.

Study details

All postpartum women from March to June 2017 were contacted after discharge via an automated call. Calls were considered successful if the woman engaged with the automated system; those who reported concerns were contacted by a nurse. UCSF researchers compared call success and presence of concerns by mode of delivery, insurance type (public or private), parity, pregnancy complication (diabetes, hypertension, hemorrhage), and neonatal intensive care (ICN) admission using univariate analyses and multivariable logistic regression.

A total of 881 women were called, and 730 (83%) were successfully contacted (meaning they engaged with the automated system through to the end of the call). About one-third of women (224 / 29%) reported a concern. Women with operative vaginal delivery were more likely to report an issue than spontaneous vaginal and cesarean delivery (42% vs 28%; P = .04). Nulliparous women also were more likely to report an issue (32% vs 25%; P = .05). They also were more likely to answer the call (86% vs 79%; P = .004). Women with public insurance were less likely to be successfully contacted (68% vs 84%; P = .003), but the frequency of concerns were equivalent (28% vs 29%). Women with neonates in the ICN were less likely to be successfully contacted. When controlling for confounders, nulliparity (odds ratio [OR], 1.5; 95% confidence interval [CI], 1.1–2.2) and private insurance (OR, 1.9; 95% CI, 1.1–3.8) both were independently associated with successful contact.

What do the results mean for practice?

Nulliparous women and women with operative vaginal deliveries may benefit from additional discharge support, concluded the researchers. “For most patients we can’t predict in advance if they will have an operative vaginal delivery but I do think that we could do more counseling in the antepartum period about different options or mode of delivery and include operative vaginal deliveries in that bucket, especially as we are doing more of them,” said Dr. Molly Siegel, Resident at UCSF. “In the postpartum period we probably should be thinking more about our instructions to those patients because we have cesarean delivery and vaginal delivery discharge instructions, and I think there needs to be something specific for operative vaginal delivery. Ultimately the goal is to improve our counseling of patients so that they don’t have as many questions after they leave the hospital.”

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

DALLAS – Fractional ablative laser treatment combined with poly-L-lactic acid (PLLA) in a patient with recessive dystrophic epidermolysis bullosa (RDEB) led to considerable clinical improvement, including thickening of the dermis, results from a case report showed.

“We have so much more to learn about how the laser treatments are modifying these intricate pathways,” lead study author Samantha Schneider, MD, said in an interview following the annual conference of the American Society for Laser Medicine and Surgery. “But, our project suggests that patients with genetic blistering diseases may benefit from fractional laser therapy in combination with topical PLLA. This may be a good option, particularly for patients who are looking for more therapeutic options for slowly healing wounds and have exhausted other more conventional treatment modalities.”

[email protected]

DALLAS – Fractional ablative laser treatment combined with poly-L-lactic acid (PLLA) in a patient with recessive dystrophic epidermolysis bullosa (RDEB) led to considerable clinical improvement, including thickening of the dermis, results from a case report showed.

“We have so much more to learn about how the laser treatments are modifying these intricate pathways,” lead study author Samantha Schneider, MD, said in an interview following the annual conference of the American Society for Laser Medicine and Surgery. “But, our project suggests that patients with genetic blistering diseases may benefit from fractional laser therapy in combination with topical PLLA. This may be a good option, particularly for patients who are looking for more therapeutic options for slowly healing wounds and have exhausted other more conventional treatment modalities.”

[email protected]

DALLAS – Fractional ablative laser treatment combined with poly-L-lactic acid (PLLA) in a patient with recessive dystrophic epidermolysis bullosa (RDEB) led to considerable clinical improvement, including thickening of the dermis, results from a case report showed.

“We have so much more to learn about how the laser treatments are modifying these intricate pathways,” lead study author Samantha Schneider, MD, said in an interview following the annual conference of the American Society for Laser Medicine and Surgery. “But, our project suggests that patients with genetic blistering diseases may benefit from fractional laser therapy in combination with topical PLLA. This may be a good option, particularly for patients who are looking for more therapeutic options for slowly healing wounds and have exhausted other more conventional treatment modalities.”

[email protected]