More than 164,690 men are expected to be diagnosed with prostate cancer in the United States in 2018.¹ Men with prostate cancer face not only stress associated with the diagnosis but also decisional conflict regarding different treatment options.² Most men diagnosed with clinically localized prostate cancer receive 1 or more of the following treatments: radical prostatectomy, external-beam radiation therapy, and/or brachytherapy, all of which are associated with posttreatment urological or sexual side effects including bowel, urinary, or erectile dysfunction.^3-5 Men who choose active surveillance may experience increased anxiety associated with the constant vigilance and monitoring of their tumor status along with the uncertainty of not definitively removing or radiating their prostate.⁶ In addition to direct functional limitations of sexual and urological side effects, treatment can also lead to secondary psychosocial effects, including depression, self-blame, embarrassment, guilt, lower masculine self-esteem, increased reticence to participate socially or engage in sexual activity, and relationship distress.^7-9 Therefore, health-related quality of life (HRQoL) and treatment satisfaction are important for this population.

Urological and sexual side effects of prostate cancer treatments are often a primary focus during treatment decision making between patients and providers. However, little prospective empirical data exist regarding the role of HRQoL and other nonurological physical and psychosocial outcomes on overall treatment satisfaction. The purpose of this study was to prospectively evaluate the role of both urological and nonurological outcomes on overall treatment satisfaction in men diagnosed with prostate cancer. We hypothesize that such an understanding can help describe changes in physical and psychosocial factors that are important to men beyond traditional urological outcomes, including their association with overall treatment satisfaction.
 

Methods

This was a prospective longitudinal assessment of patients from the Department of Urology at Northwestern University’s Feinberg School of Medicine in Chicago. Patients were eligible if they met the following inclusion criteria: they had been diagnosed with clinically localized or locally advanced prostate cancer; they had not yet received a primary treatment (eg, surgery, radiation, active surveillance) before their baseline assessment; they were 18 years or older; and they were able to read, write, speak, and understand English. Patients were excluded if they had a physical debilitation that would make participation not feasible or would create undue hardship, or if they had a history of diagnosed severe mental illness or hospitalization for chronic psychiatric reasons, as identified by referring physicians.

Eligible participants were approached before their treatment decision (if any). Patient enrollment occurred in 2 ways. For patients invited to participate during their clinic visit, the research assistant explained the study and obtained written informed consent for interested patients. A unique user identification and password was created for each patient, and they practiced using the touch screen computer while the research assistant observed and provided guidance as needed. When the patients were ready to start their pretreatment online interview, they completed the questionnaires by themselves. For patients who were invited to participate but were not scheduled to return in the foreseeable future, enrollment was carried out differently. In those cases, participating physicians contacted eligible patients who were not scheduled for a visit and informed them of the study opportunity. Interested patients were contacted by the research assistant who provided them with the study website address, which directed them to the online consent form. After a patient had completed the consent form, he was prompted to self-register. He received a unique user identification and password that could be used to complete the baseline assessment and subsequent assessments. However, for interested patients who did not have access to a computer or Internet connection, the research assistant provided them with paper consent forms and paper versions of all study assessments. After participants had completed the baseline assessment, the research assistant provided them with a written schedule of future assessments, which were expected to occur at 1 month posttreatment, 3 months posttreatment, 6 months posttreatment, and 12 months posttreatment.

For all follow-up appointments, participants could complete assessments either at clinic visits or from home using a secure online assessment platform called Assessment Center.¹⁰ The research assistant used a patient log to track participants and their progress in the study, which included study number, patient name (or initials), registration date, date of birth, sex, and timeline of completed or future assessments. The research assistant called or emailed participants (depending on patient preference) about a week before each of their follow-up assessments to facilitate adherence. If the participant did not log into the system by the target day, the research assistant contacted him the following day (target day +1) with a phone or email reminder to log into the system and complete the assessments. If the participant did not log in by midnight 1 day after the target day, the research assistant attempted to contact him one last time (target day +2) with either a reminder to log into the system or to ascertain his status that might be related to his noncompletion. Overall, a participant was called or e-mailed 1 to 3 times to remind him of his assessment. If he was unresponsive after 3 attempts, he was recorded as having withdrawn for an unknown reason.

At baseline and each follow-up time point, study participants completed a battery of patient-reported outcome measures, with most coming from the Patient-Reported Outcomes Measurement Information System (PROMIS)¹¹ and the Surgical Outcomes Measurement System (SOMS).¹² PROMIS is a National Institutes of Health (NIH) funded measurement system that has helped standardize and improve self-reported assessment of health status, symptoms, side effects, and different aspects of HRQoL, including physical, emotional, cognitive, and social health. SOMS is a suite of patient-reported outcome measures assessing important aspects of HRQoL after surgery. It was developed with feedback from surgeons, postoperative patients, and surgical nurses. PROMIS items were directly incorporated into numerous SOMS measures to facilitate easier comparisons and score crosswalks across measures and patient populations. In addition to PROMIS and SOMS measures, we also administered several well-known instruments of urological and sexual function, including the International Index of Erectile Function (IIEF) and American Urological Association Symptom Score Index (AUASS).^13,14

Outcome measures were compared across sociodemographic and clinical variables at each time point using t tests for numerical variables (age) and with chi-square or Fisher exact tests for categorical variables; those variables with significant differences were used as covariates in statistical models. To examine differences in patient-reported scores over time, we used repeated measures analysis of covariance with general linear modeling methods. We used Pearson correlation coefficients to evaluate for correlations between quality-of-life outcomes and treatment satisfaction.

Not all participants completed each of the follow-up surveys, and reasons for dropout were prospectively documented. Most participants elected surgical resection as their primary treatment compared with the fewer than 10% of patients who chose radiation or chemotherapy as their primary treatment and about 20% of men who chose active surveillance after their initial diagnosis. Therefore, our analysis focused on patients who elected surgical resection. For comparison purposes, we included the HRQoL results from active surveillance patients.

Results

A total of 105 patients diagnosed with prostate cancer were enrolled in the study. Response rates decreased throughout the study (n = 75 at 1 month; n = 71 at 3 months; n = 64 at 6 months; n = 54 at 12 months). Sociodemographic and clinical characteristics of participants are shown in Table 1. The mean change from pretreatment (baseline) scores for each measure in patients treated with surgery is shown in Table 2, and the mean change from pretreatment scores in patients who elected active surveillance is shown in Table 3 (in both tables, a negative score denotes worsened function, and a positive change denotes improvement).

After surgery, patients reported significantly lower erectile function and sexual satisfaction scores. These included statistically significant decreases for IIEF Erectile Function, IIEF Overall Satisfaction, PROMIS Sexual Satisfaction, PROMIS Sexual Interest, and PROMIS Orgasm. In patients treated with surgery, there were significant improvements in anxiety observed for patients at each follow-up time, whereas significantly worse bladder problems were observed on SOMS Bladder at 1 and 3 months but returned to baseline by 12 months after surgery. AUASS was worse at 1 month but significantly improved at 6 and 12 months. Fatigue scores significantly worsened at 1 month but were no longer significant at 6 and 12 months. Physical Function was worsened at 1 month but not throughout the rest of the study. Bowel Problems (SOMS) were significantly worse at 1 month, but changes became nonsignificant on subsequent assessments. The only 2 domains that did not demonstrate any significant changes over time were Pain Interference and Sleep Disturbance (both SOMS).

Discussion

This prospective study assessed the HRQoL from pretreatment through 12 months posttreatment in men diagnosed with clinically localized prostate cancer that had been treated with surgery. Although the indicators of sexual function significantly decreased over time, they were not meaningfully associated with overall treatment satisfaction. Instead, a host of other factors, including psychosocial (eg, anxiety, depression, body image dissatisfaction, embarrassment), nonurological physical symptoms (pain interference, physical function, sleep disturbance, fatigue), and bladder problems, were significantly related to overall treatment satisfaction. Although this may not be surprising in other clinical oncology paradigms, the sheer surfeit of focus and attention on sexual function has overshadowed aspects of HRQoL that many men report are important to them, despite worsened sexual function outcomes.

Understanding potential treatment-related changes in HRQoL can be challenging for men when choosing providers and different therapeutic options. The increasing complexity of treatment in prostate cancer has created an opportunity to not only understand efficacy on cancer control but also focus on meaningful patient-reported outcomes. Hospitals and medical groups are increasingly aware of the importance of improving the patient care experience. Objective measures of patient satisfaction for health care providers, such as the Press-Ganey and Net Promoter score, exist to measure and improve patient experience. In prostate cancer, clinicians and large groups, including governmental agencies such as the US Preventive Services Task Force, have often focused on declines in urinary and erectile function¹⁵ without considering the full impact of prostate cancer treatment on global HRQoL. Our study was a prospective, longitudinal, self-reported examination of the impact, positive and negative, of prostate cancer treatment over a 12-month period.

Numerous studies have documented the treatment-related side effects of erectile, urinary, and bowel dysfunction in patients treated for prostate cancer, which may occur after definitive local therapies.^5,16-18 The present study shows a similar impact on urinary, bowel, and erectile domains after treatment. Although erectile function scores remained lower through the course of the 12-month study, bowel and bladder domains returned to baseline by month 12. Unlike other studies, we also examined psychosocial and nonurological aspects of prostate cancer treatment. We found that there was a measurable and significant positive impact on other HRQoL measurements such as decreased anxiety. Despite a variety of declines across HRQoL domains, most patients reported that their results were largely as they had expected, and their side effects were the same or better than they had expected. No patient in the cohort reported being dissatisfied with his overall treatment, and more than 90% of patients were mostly or completely satisfied with their treatment choice. This highlights the point that while sexual and other urological domains of HRQoL are important, impairments in these areas do not necessarily reflect how many patients perceive success or satisfaction with their treatment choice. We also showed correlations between treatment satisfaction and improvement in sleep, anxiety, depression, and fatigue. It is worth noting that although there were decreases in the erectile and sexual function domains after treatment, those factors were not correlated with overall treatment satisfaction. Those factors may not routinely be assessed before, during, and after treatment for prostate cancer in most clinical encounters. However, because they were strongly associated with satisfaction with treatment outcomes in this study, identification in impairments may lead to opportunities to intervene and improve the patient experience. Therefore, important “teachable moments” may be missed (for both patients and providers) during treatment decision-making encounters if other factors beyond sexual and urological outcomes are not adequately considered and addressed. Furthermore, the results of our study may help clinicians counsel patients on their expectations for their recovery after surgery and identify particular issues related to HRQoL to pay close attention to in follow-up visits.

Strengths of our study include its prospective nature, which allowed evaluation of HRQoL outcomes at multiple time points throughout the first year after treatment. In addition, we used existing patient-reported outcome tools validated by the NIH to assess changes in HRQoL. PROMIS is an NIH-supported tool that can be leveraged in the pre- and posttreatment periods to identify patients who have impairments with HRQoL. It can provide clinicians with a unique opportunity to detect and intervene in setbacks and side effects to improve patient satisfaction and HRQoL.

Limitations of the current study include that most patients selected surgery for their treatment choice and that not all patients completed all longitudinal questionnaires, although this is expected in longitudinal studies of this nature. Although all the patients were approached and encouraged to participate, many did not participate and were not captured. In addition, not all patients completed end-of-study surveys. These factors may have biased our results because of unmeasurable factors related to nonparticipation or dropout. Our study encompassed the preoperative period up to 12 months postoperatively, which may fail to identify improvements or declines in HRQoL that may occur more than 12 months postoperatively, particularly related to continence and erectile function. The participants were enrolled by 6 surgeons, and we were not able to standardize the preoperative counseling either preoperatively or postoperatively, which may have biased our results. Finally, our study population consisted of predominantly white, married men of higher socioeconomic status; therefore, our results may not be generalizable to newly diagnosed prostate cancer patients overall.
 

Conclusions

By using validated self-administered questionnaires, we found that despite decreased sexual and urinary function, patients treated for prostate cancer were satisfied with their treatment choice. Correlates to higher patient satisfaction included decreased anxiety, depression, fatigue, and sleep disturbances.

More than 164,690 men are expected to be diagnosed with prostate cancer in the United States in 2018.¹ Men with prostate cancer face not only stress associated with the diagnosis but also decisional conflict regarding different treatment options.² Most men diagnosed with clinically localized prostate cancer receive 1 or more of the following treatments: radical prostatectomy, external-beam radiation therapy, and/or brachytherapy, all of which are associated with posttreatment urological or sexual side effects including bowel, urinary, or erectile dysfunction.^3-5 Men who choose active surveillance may experience increased anxiety associated with the constant vigilance and monitoring of their tumor status along with the uncertainty of not definitively removing or radiating their prostate.⁶ In addition to direct functional limitations of sexual and urological side effects, treatment can also lead to secondary psychosocial effects, including depression, self-blame, embarrassment, guilt, lower masculine self-esteem, increased reticence to participate socially or engage in sexual activity, and relationship distress.^7-9 Therefore, health-related quality of life (HRQoL) and treatment satisfaction are important for this population.

Urological and sexual side effects of prostate cancer treatments are often a primary focus during treatment decision making between patients and providers. However, little prospective empirical data exist regarding the role of HRQoL and other nonurological physical and psychosocial outcomes on overall treatment satisfaction. The purpose of this study was to prospectively evaluate the role of both urological and nonurological outcomes on overall treatment satisfaction in men diagnosed with prostate cancer. We hypothesize that such an understanding can help describe changes in physical and psychosocial factors that are important to men beyond traditional urological outcomes, including their association with overall treatment satisfaction.
 

Methods

This was a prospective longitudinal assessment of patients from the Department of Urology at Northwestern University’s Feinberg School of Medicine in Chicago. Patients were eligible if they met the following inclusion criteria: they had been diagnosed with clinically localized or locally advanced prostate cancer; they had not yet received a primary treatment (eg, surgery, radiation, active surveillance) before their baseline assessment; they were 18 years or older; and they were able to read, write, speak, and understand English. Patients were excluded if they had a physical debilitation that would make participation not feasible or would create undue hardship, or if they had a history of diagnosed severe mental illness or hospitalization for chronic psychiatric reasons, as identified by referring physicians.

Eligible participants were approached before their treatment decision (if any). Patient enrollment occurred in 2 ways. For patients invited to participate during their clinic visit, the research assistant explained the study and obtained written informed consent for interested patients. A unique user identification and password was created for each patient, and they practiced using the touch screen computer while the research assistant observed and provided guidance as needed. When the patients were ready to start their pretreatment online interview, they completed the questionnaires by themselves. For patients who were invited to participate but were not scheduled to return in the foreseeable future, enrollment was carried out differently. In those cases, participating physicians contacted eligible patients who were not scheduled for a visit and informed them of the study opportunity. Interested patients were contacted by the research assistant who provided them with the study website address, which directed them to the online consent form. After a patient had completed the consent form, he was prompted to self-register. He received a unique user identification and password that could be used to complete the baseline assessment and subsequent assessments. However, for interested patients who did not have access to a computer or Internet connection, the research assistant provided them with paper consent forms and paper versions of all study assessments. After participants had completed the baseline assessment, the research assistant provided them with a written schedule of future assessments, which were expected to occur at 1 month posttreatment, 3 months posttreatment, 6 months posttreatment, and 12 months posttreatment.

For all follow-up appointments, participants could complete assessments either at clinic visits or from home using a secure online assessment platform called Assessment Center.¹⁰ The research assistant used a patient log to track participants and their progress in the study, which included study number, patient name (or initials), registration date, date of birth, sex, and timeline of completed or future assessments. The research assistant called or emailed participants (depending on patient preference) about a week before each of their follow-up assessments to facilitate adherence. If the participant did not log into the system by the target day, the research assistant contacted him the following day (target day +1) with a phone or email reminder to log into the system and complete the assessments. If the participant did not log in by midnight 1 day after the target day, the research assistant attempted to contact him one last time (target day +2) with either a reminder to log into the system or to ascertain his status that might be related to his noncompletion. Overall, a participant was called or e-mailed 1 to 3 times to remind him of his assessment. If he was unresponsive after 3 attempts, he was recorded as having withdrawn for an unknown reason.

At baseline and each follow-up time point, study participants completed a battery of patient-reported outcome measures, with most coming from the Patient-Reported Outcomes Measurement Information System (PROMIS)¹¹ and the Surgical Outcomes Measurement System (SOMS).¹² PROMIS is a National Institutes of Health (NIH) funded measurement system that has helped standardize and improve self-reported assessment of health status, symptoms, side effects, and different aspects of HRQoL, including physical, emotional, cognitive, and social health. SOMS is a suite of patient-reported outcome measures assessing important aspects of HRQoL after surgery. It was developed with feedback from surgeons, postoperative patients, and surgical nurses. PROMIS items were directly incorporated into numerous SOMS measures to facilitate easier comparisons and score crosswalks across measures and patient populations. In addition to PROMIS and SOMS measures, we also administered several well-known instruments of urological and sexual function, including the International Index of Erectile Function (IIEF) and American Urological Association Symptom Score Index (AUASS).^13,14

Outcome measures were compared across sociodemographic and clinical variables at each time point using t tests for numerical variables (age) and with chi-square or Fisher exact tests for categorical variables; those variables with significant differences were used as covariates in statistical models. To examine differences in patient-reported scores over time, we used repeated measures analysis of covariance with general linear modeling methods. We used Pearson correlation coefficients to evaluate for correlations between quality-of-life outcomes and treatment satisfaction.

Not all participants completed each of the follow-up surveys, and reasons for dropout were prospectively documented. Most participants elected surgical resection as their primary treatment compared with the fewer than 10% of patients who chose radiation or chemotherapy as their primary treatment and about 20% of men who chose active surveillance after their initial diagnosis. Therefore, our analysis focused on patients who elected surgical resection. For comparison purposes, we included the HRQoL results from active surveillance patients.

Results

A total of 105 patients diagnosed with prostate cancer were enrolled in the study. Response rates decreased throughout the study (n = 75 at 1 month; n = 71 at 3 months; n = 64 at 6 months; n = 54 at 12 months). Sociodemographic and clinical characteristics of participants are shown in Table 1. The mean change from pretreatment (baseline) scores for each measure in patients treated with surgery is shown in Table 2, and the mean change from pretreatment scores in patients who elected active surveillance is shown in Table 3 (in both tables, a negative score denotes worsened function, and a positive change denotes improvement).

After surgery, patients reported significantly lower erectile function and sexual satisfaction scores. These included statistically significant decreases for IIEF Erectile Function, IIEF Overall Satisfaction, PROMIS Sexual Satisfaction, PROMIS Sexual Interest, and PROMIS Orgasm. In patients treated with surgery, there were significant improvements in anxiety observed for patients at each follow-up time, whereas significantly worse bladder problems were observed on SOMS Bladder at 1 and 3 months but returned to baseline by 12 months after surgery. AUASS was worse at 1 month but significantly improved at 6 and 12 months. Fatigue scores significantly worsened at 1 month but were no longer significant at 6 and 12 months. Physical Function was worsened at 1 month but not throughout the rest of the study. Bowel Problems (SOMS) were significantly worse at 1 month, but changes became nonsignificant on subsequent assessments. The only 2 domains that did not demonstrate any significant changes over time were Pain Interference and Sleep Disturbance (both SOMS).

Discussion

This prospective study assessed the HRQoL from pretreatment through 12 months posttreatment in men diagnosed with clinically localized prostate cancer that had been treated with surgery. Although the indicators of sexual function significantly decreased over time, they were not meaningfully associated with overall treatment satisfaction. Instead, a host of other factors, including psychosocial (eg, anxiety, depression, body image dissatisfaction, embarrassment), nonurological physical symptoms (pain interference, physical function, sleep disturbance, fatigue), and bladder problems, were significantly related to overall treatment satisfaction. Although this may not be surprising in other clinical oncology paradigms, the sheer surfeit of focus and attention on sexual function has overshadowed aspects of HRQoL that many men report are important to them, despite worsened sexual function outcomes.

Understanding potential treatment-related changes in HRQoL can be challenging for men when choosing providers and different therapeutic options. The increasing complexity of treatment in prostate cancer has created an opportunity to not only understand efficacy on cancer control but also focus on meaningful patient-reported outcomes. Hospitals and medical groups are increasingly aware of the importance of improving the patient care experience. Objective measures of patient satisfaction for health care providers, such as the Press-Ganey and Net Promoter score, exist to measure and improve patient experience. In prostate cancer, clinicians and large groups, including governmental agencies such as the US Preventive Services Task Force, have often focused on declines in urinary and erectile function¹⁵ without considering the full impact of prostate cancer treatment on global HRQoL. Our study was a prospective, longitudinal, self-reported examination of the impact, positive and negative, of prostate cancer treatment over a 12-month period.

Numerous studies have documented the treatment-related side effects of erectile, urinary, and bowel dysfunction in patients treated for prostate cancer, which may occur after definitive local therapies.^5,16-18 The present study shows a similar impact on urinary, bowel, and erectile domains after treatment. Although erectile function scores remained lower through the course of the 12-month study, bowel and bladder domains returned to baseline by month 12. Unlike other studies, we also examined psychosocial and nonurological aspects of prostate cancer treatment. We found that there was a measurable and significant positive impact on other HRQoL measurements such as decreased anxiety. Despite a variety of declines across HRQoL domains, most patients reported that their results were largely as they had expected, and their side effects were the same or better than they had expected. No patient in the cohort reported being dissatisfied with his overall treatment, and more than 90% of patients were mostly or completely satisfied with their treatment choice. This highlights the point that while sexual and other urological domains of HRQoL are important, impairments in these areas do not necessarily reflect how many patients perceive success or satisfaction with their treatment choice. We also showed correlations between treatment satisfaction and improvement in sleep, anxiety, depression, and fatigue. It is worth noting that although there were decreases in the erectile and sexual function domains after treatment, those factors were not correlated with overall treatment satisfaction. Those factors may not routinely be assessed before, during, and after treatment for prostate cancer in most clinical encounters. However, because they were strongly associated with satisfaction with treatment outcomes in this study, identification in impairments may lead to opportunities to intervene and improve the patient experience. Therefore, important “teachable moments” may be missed (for both patients and providers) during treatment decision-making encounters if other factors beyond sexual and urological outcomes are not adequately considered and addressed. Furthermore, the results of our study may help clinicians counsel patients on their expectations for their recovery after surgery and identify particular issues related to HRQoL to pay close attention to in follow-up visits.

Strengths of our study include its prospective nature, which allowed evaluation of HRQoL outcomes at multiple time points throughout the first year after treatment. In addition, we used existing patient-reported outcome tools validated by the NIH to assess changes in HRQoL. PROMIS is an NIH-supported tool that can be leveraged in the pre- and posttreatment periods to identify patients who have impairments with HRQoL. It can provide clinicians with a unique opportunity to detect and intervene in setbacks and side effects to improve patient satisfaction and HRQoL.

Limitations of the current study include that most patients selected surgery for their treatment choice and that not all patients completed all longitudinal questionnaires, although this is expected in longitudinal studies of this nature. Although all the patients were approached and encouraged to participate, many did not participate and were not captured. In addition, not all patients completed end-of-study surveys. These factors may have biased our results because of unmeasurable factors related to nonparticipation or dropout. Our study encompassed the preoperative period up to 12 months postoperatively, which may fail to identify improvements or declines in HRQoL that may occur more than 12 months postoperatively, particularly related to continence and erectile function. The participants were enrolled by 6 surgeons, and we were not able to standardize the preoperative counseling either preoperatively or postoperatively, which may have biased our results. Finally, our study population consisted of predominantly white, married men of higher socioeconomic status; therefore, our results may not be generalizable to newly diagnosed prostate cancer patients overall.
 

Conclusions

By using validated self-administered questionnaires, we found that despite decreased sexual and urinary function, patients treated for prostate cancer were satisfied with their treatment choice. Correlates to higher patient satisfaction included decreased anxiety, depression, fatigue, and sleep disturbances.

More than 164,690 men are expected to be diagnosed with prostate cancer in the United States in 2018.¹ Men with prostate cancer face not only stress associated with the diagnosis but also decisional conflict regarding different treatment options.² Most men diagnosed with clinically localized prostate cancer receive 1 or more of the following treatments: radical prostatectomy, external-beam radiation therapy, and/or brachytherapy, all of which are associated with posttreatment urological or sexual side effects including bowel, urinary, or erectile dysfunction.^3-5 Men who choose active surveillance may experience increased anxiety associated with the constant vigilance and monitoring of their tumor status along with the uncertainty of not definitively removing or radiating their prostate.⁶ In addition to direct functional limitations of sexual and urological side effects, treatment can also lead to secondary psychosocial effects, including depression, self-blame, embarrassment, guilt, lower masculine self-esteem, increased reticence to participate socially or engage in sexual activity, and relationship distress.^7-9 Therefore, health-related quality of life (HRQoL) and treatment satisfaction are important for this population.

Urological and sexual side effects of prostate cancer treatments are often a primary focus during treatment decision making between patients and providers. However, little prospective empirical data exist regarding the role of HRQoL and other nonurological physical and psychosocial outcomes on overall treatment satisfaction. The purpose of this study was to prospectively evaluate the role of both urological and nonurological outcomes on overall treatment satisfaction in men diagnosed with prostate cancer. We hypothesize that such an understanding can help describe changes in physical and psychosocial factors that are important to men beyond traditional urological outcomes, including their association with overall treatment satisfaction.
 

Methods

This was a prospective longitudinal assessment of patients from the Department of Urology at Northwestern University’s Feinberg School of Medicine in Chicago. Patients were eligible if they met the following inclusion criteria: they had been diagnosed with clinically localized or locally advanced prostate cancer; they had not yet received a primary treatment (eg, surgery, radiation, active surveillance) before their baseline assessment; they were 18 years or older; and they were able to read, write, speak, and understand English. Patients were excluded if they had a physical debilitation that would make participation not feasible or would create undue hardship, or if they had a history of diagnosed severe mental illness or hospitalization for chronic psychiatric reasons, as identified by referring physicians.

Eligible participants were approached before their treatment decision (if any). Patient enrollment occurred in 2 ways. For patients invited to participate during their clinic visit, the research assistant explained the study and obtained written informed consent for interested patients. A unique user identification and password was created for each patient, and they practiced using the touch screen computer while the research assistant observed and provided guidance as needed. When the patients were ready to start their pretreatment online interview, they completed the questionnaires by themselves. For patients who were invited to participate but were not scheduled to return in the foreseeable future, enrollment was carried out differently. In those cases, participating physicians contacted eligible patients who were not scheduled for a visit and informed them of the study opportunity. Interested patients were contacted by the research assistant who provided them with the study website address, which directed them to the online consent form. After a patient had completed the consent form, he was prompted to self-register. He received a unique user identification and password that could be used to complete the baseline assessment and subsequent assessments. However, for interested patients who did not have access to a computer or Internet connection, the research assistant provided them with paper consent forms and paper versions of all study assessments. After participants had completed the baseline assessment, the research assistant provided them with a written schedule of future assessments, which were expected to occur at 1 month posttreatment, 3 months posttreatment, 6 months posttreatment, and 12 months posttreatment.

For all follow-up appointments, participants could complete assessments either at clinic visits or from home using a secure online assessment platform called Assessment Center.¹⁰ The research assistant used a patient log to track participants and their progress in the study, which included study number, patient name (or initials), registration date, date of birth, sex, and timeline of completed or future assessments. The research assistant called or emailed participants (depending on patient preference) about a week before each of their follow-up assessments to facilitate adherence. If the participant did not log into the system by the target day, the research assistant contacted him the following day (target day +1) with a phone or email reminder to log into the system and complete the assessments. If the participant did not log in by midnight 1 day after the target day, the research assistant attempted to contact him one last time (target day +2) with either a reminder to log into the system or to ascertain his status that might be related to his noncompletion. Overall, a participant was called or e-mailed 1 to 3 times to remind him of his assessment. If he was unresponsive after 3 attempts, he was recorded as having withdrawn for an unknown reason.

At baseline and each follow-up time point, study participants completed a battery of patient-reported outcome measures, with most coming from the Patient-Reported Outcomes Measurement Information System (PROMIS)¹¹ and the Surgical Outcomes Measurement System (SOMS).¹² PROMIS is a National Institutes of Health (NIH) funded measurement system that has helped standardize and improve self-reported assessment of health status, symptoms, side effects, and different aspects of HRQoL, including physical, emotional, cognitive, and social health. SOMS is a suite of patient-reported outcome measures assessing important aspects of HRQoL after surgery. It was developed with feedback from surgeons, postoperative patients, and surgical nurses. PROMIS items were directly incorporated into numerous SOMS measures to facilitate easier comparisons and score crosswalks across measures and patient populations. In addition to PROMIS and SOMS measures, we also administered several well-known instruments of urological and sexual function, including the International Index of Erectile Function (IIEF) and American Urological Association Symptom Score Index (AUASS).^13,14

Outcome measures were compared across sociodemographic and clinical variables at each time point using t tests for numerical variables (age) and with chi-square or Fisher exact tests for categorical variables; those variables with significant differences were used as covariates in statistical models. To examine differences in patient-reported scores over time, we used repeated measures analysis of covariance with general linear modeling methods. We used Pearson correlation coefficients to evaluate for correlations between quality-of-life outcomes and treatment satisfaction.

Not all participants completed each of the follow-up surveys, and reasons for dropout were prospectively documented. Most participants elected surgical resection as their primary treatment compared with the fewer than 10% of patients who chose radiation or chemotherapy as their primary treatment and about 20% of men who chose active surveillance after their initial diagnosis. Therefore, our analysis focused on patients who elected surgical resection. For comparison purposes, we included the HRQoL results from active surveillance patients.

Results

A total of 105 patients diagnosed with prostate cancer were enrolled in the study. Response rates decreased throughout the study (n = 75 at 1 month; n = 71 at 3 months; n = 64 at 6 months; n = 54 at 12 months). Sociodemographic and clinical characteristics of participants are shown in Table 1. The mean change from pretreatment (baseline) scores for each measure in patients treated with surgery is shown in Table 2, and the mean change from pretreatment scores in patients who elected active surveillance is shown in Table 3 (in both tables, a negative score denotes worsened function, and a positive change denotes improvement).

After surgery, patients reported significantly lower erectile function and sexual satisfaction scores. These included statistically significant decreases for IIEF Erectile Function, IIEF Overall Satisfaction, PROMIS Sexual Satisfaction, PROMIS Sexual Interest, and PROMIS Orgasm. In patients treated with surgery, there were significant improvements in anxiety observed for patients at each follow-up time, whereas significantly worse bladder problems were observed on SOMS Bladder at 1 and 3 months but returned to baseline by 12 months after surgery. AUASS was worse at 1 month but significantly improved at 6 and 12 months. Fatigue scores significantly worsened at 1 month but were no longer significant at 6 and 12 months. Physical Function was worsened at 1 month but not throughout the rest of the study. Bowel Problems (SOMS) were significantly worse at 1 month, but changes became nonsignificant on subsequent assessments. The only 2 domains that did not demonstrate any significant changes over time were Pain Interference and Sleep Disturbance (both SOMS).

Discussion

This prospective study assessed the HRQoL from pretreatment through 12 months posttreatment in men diagnosed with clinically localized prostate cancer that had been treated with surgery. Although the indicators of sexual function significantly decreased over time, they were not meaningfully associated with overall treatment satisfaction. Instead, a host of other factors, including psychosocial (eg, anxiety, depression, body image dissatisfaction, embarrassment), nonurological physical symptoms (pain interference, physical function, sleep disturbance, fatigue), and bladder problems, were significantly related to overall treatment satisfaction. Although this may not be surprising in other clinical oncology paradigms, the sheer surfeit of focus and attention on sexual function has overshadowed aspects of HRQoL that many men report are important to them, despite worsened sexual function outcomes.

Understanding potential treatment-related changes in HRQoL can be challenging for men when choosing providers and different therapeutic options. The increasing complexity of treatment in prostate cancer has created an opportunity to not only understand efficacy on cancer control but also focus on meaningful patient-reported outcomes. Hospitals and medical groups are increasingly aware of the importance of improving the patient care experience. Objective measures of patient satisfaction for health care providers, such as the Press-Ganey and Net Promoter score, exist to measure and improve patient experience. In prostate cancer, clinicians and large groups, including governmental agencies such as the US Preventive Services Task Force, have often focused on declines in urinary and erectile function¹⁵ without considering the full impact of prostate cancer treatment on global HRQoL. Our study was a prospective, longitudinal, self-reported examination of the impact, positive and negative, of prostate cancer treatment over a 12-month period.

Numerous studies have documented the treatment-related side effects of erectile, urinary, and bowel dysfunction in patients treated for prostate cancer, which may occur after definitive local therapies.^5,16-18 The present study shows a similar impact on urinary, bowel, and erectile domains after treatment. Although erectile function scores remained lower through the course of the 12-month study, bowel and bladder domains returned to baseline by month 12. Unlike other studies, we also examined psychosocial and nonurological aspects of prostate cancer treatment. We found that there was a measurable and significant positive impact on other HRQoL measurements such as decreased anxiety. Despite a variety of declines across HRQoL domains, most patients reported that their results were largely as they had expected, and their side effects were the same or better than they had expected. No patient in the cohort reported being dissatisfied with his overall treatment, and more than 90% of patients were mostly or completely satisfied with their treatment choice. This highlights the point that while sexual and other urological domains of HRQoL are important, impairments in these areas do not necessarily reflect how many patients perceive success or satisfaction with their treatment choice. We also showed correlations between treatment satisfaction and improvement in sleep, anxiety, depression, and fatigue. It is worth noting that although there were decreases in the erectile and sexual function domains after treatment, those factors were not correlated with overall treatment satisfaction. Those factors may not routinely be assessed before, during, and after treatment for prostate cancer in most clinical encounters. However, because they were strongly associated with satisfaction with treatment outcomes in this study, identification in impairments may lead to opportunities to intervene and improve the patient experience. Therefore, important “teachable moments” may be missed (for both patients and providers) during treatment decision-making encounters if other factors beyond sexual and urological outcomes are not adequately considered and addressed. Furthermore, the results of our study may help clinicians counsel patients on their expectations for their recovery after surgery and identify particular issues related to HRQoL to pay close attention to in follow-up visits.

Strengths of our study include its prospective nature, which allowed evaluation of HRQoL outcomes at multiple time points throughout the first year after treatment. In addition, we used existing patient-reported outcome tools validated by the NIH to assess changes in HRQoL. PROMIS is an NIH-supported tool that can be leveraged in the pre- and posttreatment periods to identify patients who have impairments with HRQoL. It can provide clinicians with a unique opportunity to detect and intervene in setbacks and side effects to improve patient satisfaction and HRQoL.

Limitations of the current study include that most patients selected surgery for their treatment choice and that not all patients completed all longitudinal questionnaires, although this is expected in longitudinal studies of this nature. Although all the patients were approached and encouraged to participate, many did not participate and were not captured. In addition, not all patients completed end-of-study surveys. These factors may have biased our results because of unmeasurable factors related to nonparticipation or dropout. Our study encompassed the preoperative period up to 12 months postoperatively, which may fail to identify improvements or declines in HRQoL that may occur more than 12 months postoperatively, particularly related to continence and erectile function. The participants were enrolled by 6 surgeons, and we were not able to standardize the preoperative counseling either preoperatively or postoperatively, which may have biased our results. Finally, our study population consisted of predominantly white, married men of higher socioeconomic status; therefore, our results may not be generalizable to newly diagnosed prostate cancer patients overall.
 

Conclusions

By using validated self-administered questionnaires, we found that despite decreased sexual and urinary function, patients treated for prostate cancer were satisfied with their treatment choice. Correlates to higher patient satisfaction included decreased anxiety, depression, fatigue, and sleep disturbances.

Thirteen members of the Advisory Committee on Immunization Practices (ACIP) voted to approve the influenza vaccine recommendations for 2018-2019, while one member abstained from voting at the summer ACIP meeting.

The 2018-2019 recommendation maintains the core recommendation that influenza vaccines should be administered to all persons 6 months or older who have no contraindications.

Jovanmandic/Thinkstock

Thirteen members of the Advisory Committee on Immunization Practices (ACIP) voted to approve the influenza vaccine recommendations for 2018-2019, while one member abstained from voting at the summer ACIP meeting.

The 2018-2019 recommendation maintains the core recommendation that influenza vaccines should be administered to all persons 6 months or older who have no contraindications.

Jovanmandic/Thinkstock

Thirteen members of the Advisory Committee on Immunization Practices (ACIP) voted to approve the influenza vaccine recommendations for 2018-2019, while one member abstained from voting at the summer ACIP meeting.

The 2018-2019 recommendation maintains the core recommendation that influenza vaccines should be administered to all persons 6 months or older who have no contraindications.

Jovanmandic/Thinkstock

A move toward more individualized treatment of hyperglycemia is coming in the next American Diabetes Association/European Association for the Study of Diabetes Consensus Report, according to John B. Buse, MD, PhD, cochair of the committee writing the new consensus statement.

He will present a draft of the statement on the management of hyperglycemia in type 2 diabetes at the ADA’s annual scientific sessions in Orlando.

When finalized – after revisions based on comments and feedback from diabetes care providers – clinical researchers, patient groups, payers, regulators, and stakeholders – the statement will update the last revision, issued in 2015.

“We are taking a new look at hyperglycemia based on the many studies conducted since 2014, particularly the cardiovascular outcomes trials,” Dr. Buse, the Verne S. Caviness Distinguished Professor in the division of endocrinology and metabolism and chief of endocrinology at the University of North Carolina, Chapel Hill, said in a statement.

A move toward more individualized treatment of hyperglycemia is coming in the next American Diabetes Association/European Association for the Study of Diabetes Consensus Report, according to John B. Buse, MD, PhD, cochair of the committee writing the new consensus statement.

He will present a draft of the statement on the management of hyperglycemia in type 2 diabetes at the ADA’s annual scientific sessions in Orlando.

When finalized – after revisions based on comments and feedback from diabetes care providers – clinical researchers, patient groups, payers, regulators, and stakeholders – the statement will update the last revision, issued in 2015.

“We are taking a new look at hyperglycemia based on the many studies conducted since 2014, particularly the cardiovascular outcomes trials,” Dr. Buse, the Verne S. Caviness Distinguished Professor in the division of endocrinology and metabolism and chief of endocrinology at the University of North Carolina, Chapel Hill, said in a statement.

A move toward more individualized treatment of hyperglycemia is coming in the next American Diabetes Association/European Association for the Study of Diabetes Consensus Report, according to John B. Buse, MD, PhD, cochair of the committee writing the new consensus statement.

He will present a draft of the statement on the management of hyperglycemia in type 2 diabetes at the ADA’s annual scientific sessions in Orlando.

When finalized – after revisions based on comments and feedback from diabetes care providers – clinical researchers, patient groups, payers, regulators, and stakeholders – the statement will update the last revision, issued in 2015.

“We are taking a new look at hyperglycemia based on the many studies conducted since 2014, particularly the cardiovascular outcomes trials,” Dr. Buse, the Verne S. Caviness Distinguished Professor in the division of endocrinology and metabolism and chief of endocrinology at the University of North Carolina, Chapel Hill, said in a statement.

The use of permanent cosmetics dates back thousands of years in history. Microblading, a technique for creating natural looking eyebrows using pigment, has reemerged in popularity in the 21st century, and has rapidly become one of the most popular cosmetic procedures in the United States. However, it has not completely replaced traditional eyebrow micropigmentation techniques: Many people may not be candidates for microblading because of how the pigment is manually deposited in the skin through tiny “tears” in the skin with this procedure.

The use of microblading has increased exponentially since 2015, as reflected by the millions of searches on popular social media sites. With the increase in the popularity and volume of tattoo artists performing these procedures, there has also been an increase in side effects and complications from microblading provided by poorly trained and unlicensed “artists,” a problem facilitated by the absence of adequate training requirements and/or regulatory oversight in many states.

Lola Jonsson, Skin Care and Laser Physicians of Beverly Hills.

Lola Jonsson, Skin Care and Laser Physicians of Beverly Hills.

Dr. Talakoub and Dr. Wesley and are co-contributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. They had no relevant disclosures. Write to them at [email protected]. This column was written with the help and professional expertise of Emily Joy, a cosmetic tattoo artist and the founder of Dollistic in McLean.

The use of permanent cosmetics dates back thousands of years in history. Microblading, a technique for creating natural looking eyebrows using pigment, has reemerged in popularity in the 21st century, and has rapidly become one of the most popular cosmetic procedures in the United States. However, it has not completely replaced traditional eyebrow micropigmentation techniques: Many people may not be candidates for microblading because of how the pigment is manually deposited in the skin through tiny “tears” in the skin with this procedure.

The use of microblading has increased exponentially since 2015, as reflected by the millions of searches on popular social media sites. With the increase in the popularity and volume of tattoo artists performing these procedures, there has also been an increase in side effects and complications from microblading provided by poorly trained and unlicensed “artists,” a problem facilitated by the absence of adequate training requirements and/or regulatory oversight in many states.

Lola Jonsson, Skin Care and Laser Physicians of Beverly Hills.

Lola Jonsson, Skin Care and Laser Physicians of Beverly Hills.

Dr. Talakoub and Dr. Wesley and are co-contributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. They had no relevant disclosures. Write to them at [email protected]. This column was written with the help and professional expertise of Emily Joy, a cosmetic tattoo artist and the founder of Dollistic in McLean.

The use of permanent cosmetics dates back thousands of years in history. Microblading, a technique for creating natural looking eyebrows using pigment, has reemerged in popularity in the 21st century, and has rapidly become one of the most popular cosmetic procedures in the United States. However, it has not completely replaced traditional eyebrow micropigmentation techniques: Many people may not be candidates for microblading because of how the pigment is manually deposited in the skin through tiny “tears” in the skin with this procedure.

The use of microblading has increased exponentially since 2015, as reflected by the millions of searches on popular social media sites. With the increase in the popularity and volume of tattoo artists performing these procedures, there has also been an increase in side effects and complications from microblading provided by poorly trained and unlicensed “artists,” a problem facilitated by the absence of adequate training requirements and/or regulatory oversight in many states.

Lola Jonsson, Skin Care and Laser Physicians of Beverly Hills.

Lola Jonsson, Skin Care and Laser Physicians of Beverly Hills.

Dr. Talakoub and Dr. Wesley and are co-contributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. They had no relevant disclosures. Write to them at [email protected]. This column was written with the help and professional expertise of Emily Joy, a cosmetic tattoo artist and the founder of Dollistic in McLean.

Click Here to Read Supplement.

Bacterial vaginosis (BV) affects women worldwide and recurrent BV can be a frustrating condition for both patients and providers. In this new supplement, expert Khady Diouf, MD, discusses her treatment approach and suggested counseling for patients with recurrent BV.

Click Here to Read the Supplement. 

Click Here to Read Supplement.

Bacterial vaginosis (BV) affects women worldwide and recurrent BV can be a frustrating condition for both patients and providers. In this new supplement, expert Khady Diouf, MD, discusses her treatment approach and suggested counseling for patients with recurrent BV.

Click Here to Read the Supplement. 

Click Here to Read Supplement.

Bacterial vaginosis (BV) affects women worldwide and recurrent BV can be a frustrating condition for both patients and providers. In this new supplement, expert Khady Diouf, MD, discusses her treatment approach and suggested counseling for patients with recurrent BV.

Click Here to Read the Supplement. 

Treatment of gastroesophageal reflux (GER) in preterm infants with traditional treatments, such as body positioning, and newer treatments with pharmacologic agents appear to be ineffective, and pharmacologic agents in particular may cause significant harm, according to a clinical report by the American Academy of Pediatrics Committee on Fetus and Newborn.

“I think that probably the most important point for any physician, including neonatologists, is that the committee concluded on the basis of the evidence that gastroesophageal reflux is a normal phenomenon that happens in almost all preterm infants,” Eric Eichenwald, MD, lead author of the committee’s clinical report and chief of neonatology at Children’s Hospital of Philadelphia, said in an interview. “So really the bottom line of the clinical report is watchful waiting, conservative management, and patience is the most important approach to a baby that you think is suffering from reflux.”

andresr/Getty Images

Pharmacologic management

The committee members focused on four categories of pharmacologic interventions in their report in Pediatrics.

Prokinetic (promotility) agents, such as metoclopramide, domperidone, and erythromycin, are widely used in treating symptoms of GER in older infants and appear to improve gastric emptying, reduce regurgitation, and enhance lower esophageal sphincter tone, but they do not appear to reduce GER symptoms in preterm infants. In addition to not being effective in these infants, there is also a potential for significant adverse events, including cardiac arrhythmia and neurologic side effects. Another common pharmacologic treatment is the use of sodium alginate in combination with sodium bicarbonate. In the presence of gastric acid, sodium alginate precipitates as a gel that forms a physical barrier that protects the gastric mucosa. When sodium bicarbonate is added, a carbon dioxide foam forms that is less harmful to the esophagus than GER-related fluids. While this combination treatment has reduced the number of acidic GER exposures and esophageal acid exposure in preterm infants in small studies, the long-term safety has not been evaluated in this populations.

Histamine₂ (H₂) blockers, like famotidine and ranitidine, also are commonly prescribed to treat preterm infant gastroesophageal reflux. H_{2 blockers} compete with H₂ for the histamine receptors of the parietal cells, which causes a decrease in hydrochloric acid and a subsequent increase in intragastric pH. These are often prescribed on the premise that GER symptoms are secondary to acid reflux in the lower esophagus, but there is no research on the efficacy of H₂ blockers on the symptom profile of GER in preterm infants. This class of drugs also has been linked with an increased risk of necrotizing enterocolitis and a higher incidence of late-onset infections and death. This is thought to be caused by alteration of the intestinal microbiome, according to the clinical report.

Proton pump inhibitors (PPIs) are another treatment for reducing acid secretion by the parietal cells, but are largely ineffective in relieving clinical signs of GER in preterm infants. PPIs also have been associated with a higher risk of bacterial overgrowth, gastroenteritis, and community-acquired pneumonia in older children. It is theorized that, because of the acid mitigating effects of PPIs, they will have the potential for adverse effects similar to those seen with H₂ blockers, although this has not been investigated.
 

Traditional treatments

Dr. Eichenwald also was quick to point out that even traditional methods of treating preterm infant GER are not particularly effective.

“Some of the conservative approaches that have been advocated include head-up position and different ways of side-lying to enhance emptying of the stomach after feeding. And none of those have been shown to reduce clinically appreciated signs of reflux in preterm infants. If anything – in term babies – some of those positions have been shown to increase the amount of reflux,” he said in an interview.

“I think that the other important point to make about this is that there are many signs that clinicians attribute to reflux in preterm babies, which include wakefulness, irritability, arching after a feeding. And none of those behaviors have been shown to be associated with reflux when it’s critically examined using either a pH Probe or multichannel impedance monitoring. And therefore the treatments to try to decrease reflux don’t really have an effect on those behaviors either.”
 

Parental concern

Treating a pediatric issue is not as simple as diagnosis and treatment. Often, parents are justifiably concerned about their children. Dr. Eichenwald sees educating parents as an important facet of treating GER in preterm infants.

“Quite honestly I think that there’s some projection on the part of adults who say, ‘I know how I feel when I have heartburn, which is the adult equivalent of reflux, and the baby must be experiencing the same thing, and that’s why they’re acting uncomfortable,’ ” suggested Dr. Eichenwald. “I think that it’s important for clinicians to educate families that a lot of the signs that we typically have attributed to gastroesophageal reflux are not really related to it.”

With both traditional and pharmacological interventions failing to treat preterm infant GER, Dr. Eichenwald believes that the most effective treatment could be patiently waiting. “I think that the important thing to stress is that reflux is a normal physiologic phenomenon. It rarely causes pathology in preterm infants, and therefore, in treating it, you’re not treating any pathology. You should just be patient and it will likely just go away on its own.”

Dr. Eichenwald has no potential conflicts of interest or external funding to report.

[email protected]

SOURCE: Eichenwald E et al. Pediatrics. 2018 June. doi: 10.1542/peds.2018-1061 .

Treatment of gastroesophageal reflux (GER) in preterm infants with traditional treatments, such as body positioning, and newer treatments with pharmacologic agents appear to be ineffective, and pharmacologic agents in particular may cause significant harm, according to a clinical report by the American Academy of Pediatrics Committee on Fetus and Newborn.

“I think that probably the most important point for any physician, including neonatologists, is that the committee concluded on the basis of the evidence that gastroesophageal reflux is a normal phenomenon that happens in almost all preterm infants,” Eric Eichenwald, MD, lead author of the committee’s clinical report and chief of neonatology at Children’s Hospital of Philadelphia, said in an interview. “So really the bottom line of the clinical report is watchful waiting, conservative management, and patience is the most important approach to a baby that you think is suffering from reflux.”

andresr/Getty Images

Pharmacologic management

The committee members focused on four categories of pharmacologic interventions in their report in Pediatrics.

Prokinetic (promotility) agents, such as metoclopramide, domperidone, and erythromycin, are widely used in treating symptoms of GER in older infants and appear to improve gastric emptying, reduce regurgitation, and enhance lower esophageal sphincter tone, but they do not appear to reduce GER symptoms in preterm infants. In addition to not being effective in these infants, there is also a potential for significant adverse events, including cardiac arrhythmia and neurologic side effects. Another common pharmacologic treatment is the use of sodium alginate in combination with sodium bicarbonate. In the presence of gastric acid, sodium alginate precipitates as a gel that forms a physical barrier that protects the gastric mucosa. When sodium bicarbonate is added, a carbon dioxide foam forms that is less harmful to the esophagus than GER-related fluids. While this combination treatment has reduced the number of acidic GER exposures and esophageal acid exposure in preterm infants in small studies, the long-term safety has not been evaluated in this populations.

Histamine₂ (H₂) blockers, like famotidine and ranitidine, also are commonly prescribed to treat preterm infant gastroesophageal reflux. H_{2 blockers} compete with H₂ for the histamine receptors of the parietal cells, which causes a decrease in hydrochloric acid and a subsequent increase in intragastric pH. These are often prescribed on the premise that GER symptoms are secondary to acid reflux in the lower esophagus, but there is no research on the efficacy of H₂ blockers on the symptom profile of GER in preterm infants. This class of drugs also has been linked with an increased risk of necrotizing enterocolitis and a higher incidence of late-onset infections and death. This is thought to be caused by alteration of the intestinal microbiome, according to the clinical report.

Proton pump inhibitors (PPIs) are another treatment for reducing acid secretion by the parietal cells, but are largely ineffective in relieving clinical signs of GER in preterm infants. PPIs also have been associated with a higher risk of bacterial overgrowth, gastroenteritis, and community-acquired pneumonia in older children. It is theorized that, because of the acid mitigating effects of PPIs, they will have the potential for adverse effects similar to those seen with H₂ blockers, although this has not been investigated.
 

Traditional treatments

Dr. Eichenwald also was quick to point out that even traditional methods of treating preterm infant GER are not particularly effective.

“Some of the conservative approaches that have been advocated include head-up position and different ways of side-lying to enhance emptying of the stomach after feeding. And none of those have been shown to reduce clinically appreciated signs of reflux in preterm infants. If anything – in term babies – some of those positions have been shown to increase the amount of reflux,” he said in an interview.

“I think that the other important point to make about this is that there are many signs that clinicians attribute to reflux in preterm babies, which include wakefulness, irritability, arching after a feeding. And none of those behaviors have been shown to be associated with reflux when it’s critically examined using either a pH Probe or multichannel impedance monitoring. And therefore the treatments to try to decrease reflux don’t really have an effect on those behaviors either.”
 

Parental concern

Treating a pediatric issue is not as simple as diagnosis and treatment. Often, parents are justifiably concerned about their children. Dr. Eichenwald sees educating parents as an important facet of treating GER in preterm infants.

“Quite honestly I think that there’s some projection on the part of adults who say, ‘I know how I feel when I have heartburn, which is the adult equivalent of reflux, and the baby must be experiencing the same thing, and that’s why they’re acting uncomfortable,’ ” suggested Dr. Eichenwald. “I think that it’s important for clinicians to educate families that a lot of the signs that we typically have attributed to gastroesophageal reflux are not really related to it.”

With both traditional and pharmacological interventions failing to treat preterm infant GER, Dr. Eichenwald believes that the most effective treatment could be patiently waiting. “I think that the important thing to stress is that reflux is a normal physiologic phenomenon. It rarely causes pathology in preterm infants, and therefore, in treating it, you’re not treating any pathology. You should just be patient and it will likely just go away on its own.”

Dr. Eichenwald has no potential conflicts of interest or external funding to report.

[email protected]

SOURCE: Eichenwald E et al. Pediatrics. 2018 June. doi: 10.1542/peds.2018-1061 .

Treatment of gastroesophageal reflux (GER) in preterm infants with traditional treatments, such as body positioning, and newer treatments with pharmacologic agents appear to be ineffective, and pharmacologic agents in particular may cause significant harm, according to a clinical report by the American Academy of Pediatrics Committee on Fetus and Newborn.

“I think that probably the most important point for any physician, including neonatologists, is that the committee concluded on the basis of the evidence that gastroesophageal reflux is a normal phenomenon that happens in almost all preterm infants,” Eric Eichenwald, MD, lead author of the committee’s clinical report and chief of neonatology at Children’s Hospital of Philadelphia, said in an interview. “So really the bottom line of the clinical report is watchful waiting, conservative management, and patience is the most important approach to a baby that you think is suffering from reflux.”

andresr/Getty Images

Pharmacologic management

The committee members focused on four categories of pharmacologic interventions in their report in Pediatrics.

Prokinetic (promotility) agents, such as metoclopramide, domperidone, and erythromycin, are widely used in treating symptoms of GER in older infants and appear to improve gastric emptying, reduce regurgitation, and enhance lower esophageal sphincter tone, but they do not appear to reduce GER symptoms in preterm infants. In addition to not being effective in these infants, there is also a potential for significant adverse events, including cardiac arrhythmia and neurologic side effects. Another common pharmacologic treatment is the use of sodium alginate in combination with sodium bicarbonate. In the presence of gastric acid, sodium alginate precipitates as a gel that forms a physical barrier that protects the gastric mucosa. When sodium bicarbonate is added, a carbon dioxide foam forms that is less harmful to the esophagus than GER-related fluids. While this combination treatment has reduced the number of acidic GER exposures and esophageal acid exposure in preterm infants in small studies, the long-term safety has not been evaluated in this populations.

Histamine₂ (H₂) blockers, like famotidine and ranitidine, also are commonly prescribed to treat preterm infant gastroesophageal reflux. H_{2 blockers} compete with H₂ for the histamine receptors of the parietal cells, which causes a decrease in hydrochloric acid and a subsequent increase in intragastric pH. These are often prescribed on the premise that GER symptoms are secondary to acid reflux in the lower esophagus, but there is no research on the efficacy of H₂ blockers on the symptom profile of GER in preterm infants. This class of drugs also has been linked with an increased risk of necrotizing enterocolitis and a higher incidence of late-onset infections and death. This is thought to be caused by alteration of the intestinal microbiome, according to the clinical report.

Proton pump inhibitors (PPIs) are another treatment for reducing acid secretion by the parietal cells, but are largely ineffective in relieving clinical signs of GER in preterm infants. PPIs also have been associated with a higher risk of bacterial overgrowth, gastroenteritis, and community-acquired pneumonia in older children. It is theorized that, because of the acid mitigating effects of PPIs, they will have the potential for adverse effects similar to those seen with H₂ blockers, although this has not been investigated.
 

Traditional treatments

Dr. Eichenwald also was quick to point out that even traditional methods of treating preterm infant GER are not particularly effective.

“Some of the conservative approaches that have been advocated include head-up position and different ways of side-lying to enhance emptying of the stomach after feeding. And none of those have been shown to reduce clinically appreciated signs of reflux in preterm infants. If anything – in term babies – some of those positions have been shown to increase the amount of reflux,” he said in an interview.

“I think that the other important point to make about this is that there are many signs that clinicians attribute to reflux in preterm babies, which include wakefulness, irritability, arching after a feeding. And none of those behaviors have been shown to be associated with reflux when it’s critically examined using either a pH Probe or multichannel impedance monitoring. And therefore the treatments to try to decrease reflux don’t really have an effect on those behaviors either.”
 

Parental concern

Treating a pediatric issue is not as simple as diagnosis and treatment. Often, parents are justifiably concerned about their children. Dr. Eichenwald sees educating parents as an important facet of treating GER in preterm infants.

“Quite honestly I think that there’s some projection on the part of adults who say, ‘I know how I feel when I have heartburn, which is the adult equivalent of reflux, and the baby must be experiencing the same thing, and that’s why they’re acting uncomfortable,’ ” suggested Dr. Eichenwald. “I think that it’s important for clinicians to educate families that a lot of the signs that we typically have attributed to gastroesophageal reflux are not really related to it.”

With both traditional and pharmacological interventions failing to treat preterm infant GER, Dr. Eichenwald believes that the most effective treatment could be patiently waiting. “I think that the important thing to stress is that reflux is a normal physiologic phenomenon. It rarely causes pathology in preterm infants, and therefore, in treating it, you’re not treating any pathology. You should just be patient and it will likely just go away on its own.”

Dr. Eichenwald has no potential conflicts of interest or external funding to report.

[email protected]

SOURCE: Eichenwald E et al. Pediatrics. 2018 June. doi: 10.1542/peds.2018-1061 .

Nearly half of patients with Parkinson’s disease who were taking dopamine agonist treatment experienced impulse control disorders over a follow-up of 5 years, according to recently published results of a longitudinal study.

The 5-year cumulative incidence of impulse control disorders was approximately 45% in the study, which included 411 patients with a high prevalence of dopamine agonist use and disease duration of 5 years or less at baseline.

There was a strong association between dopamine agonist use and impulse control disorders in the study, which was conducted by Jean-Christophe Corvol, MD, of Publique Hôpitaux de Paris and his coinvestigators.

Impulse disorders increased in incidence with both duration and dose of dopamine agonists and resolved progressively after discontinuation of those agents, the investigators reported online June 20 in Neurology. The investigators used item 1.6 of part I of the Movement Disorder Society Unified Parkinson’s Disease Rating Scale to determine the presence of an impulse control disorder.

“Given the high cumulative incidence of impulse control disorders in patients with Parkinson’s disease, these adverse effects should be carefully monitored in patients ever treated with dopamine agonists,” Dr. Corvol and his coauthors wrote.

The results came from the ongoing Drug Interaction With Genes in Parkinson’s Disease (DIGPD) study, a longitudinal cohort study including Parkinson’s disease patients consecutively recruited between 2009 and 2013 at eight French hospitals. All patients had no more than 5 years of disease duration at recruitment, and follow-up included annual evaluations by movement disorder specialists.

At baseline, the majority of patients (302, or 73.5%) had taken dopamine agonists within the past 12 months.

Over the course of 5 years, the prevalence of impulse control disorders increased from 19.7% at baseline to 32.8%, Dr. Corvol and his colleagues reported.

Among 306 patients with no impulse control disorders at baseline, 94 developed one, for a 5-year cumulative incidence of 46.1%, they added. Only 4 of the 94 new cases occurred in patients who never used dopamine agonists.

Dopamine agonist use in the previous 12 months was associated with a 2.23-fold higher prevalence of impulse control disorders (P less than .001), with prevalence increasing along with average daily dose and cumulative dose duration over that time period, according to the investigators.

These findings suggests tools are needed to screen for impulse control disorders and identify high-risk patients, they said.

“Further studies are needed to understand the mechanisms involved in the relation between [dopamine agonists] and [impulse control disorders], in particular the role of apathy, anxiety, and depression,” they added.

The study was funded by grants from the French Ministry of Health and from the French Drug Agency. Dr. Corvol and many of his colleagues reported financial disclosures with many pharmaceutical companies.

SOURCE: Corvol J-C et al. Neurology. 2018 Jun 20. doi: 10.1212/WNL.0000000000005816.

Nearly half of patients with Parkinson’s disease who were taking dopamine agonist treatment experienced impulse control disorders over a follow-up of 5 years, according to recently published results of a longitudinal study.

The 5-year cumulative incidence of impulse control disorders was approximately 45% in the study, which included 411 patients with a high prevalence of dopamine agonist use and disease duration of 5 years or less at baseline.

There was a strong association between dopamine agonist use and impulse control disorders in the study, which was conducted by Jean-Christophe Corvol, MD, of Publique Hôpitaux de Paris and his coinvestigators.

Impulse disorders increased in incidence with both duration and dose of dopamine agonists and resolved progressively after discontinuation of those agents, the investigators reported online June 20 in Neurology. The investigators used item 1.6 of part I of the Movement Disorder Society Unified Parkinson’s Disease Rating Scale to determine the presence of an impulse control disorder.

“Given the high cumulative incidence of impulse control disorders in patients with Parkinson’s disease, these adverse effects should be carefully monitored in patients ever treated with dopamine agonists,” Dr. Corvol and his coauthors wrote.

The results came from the ongoing Drug Interaction With Genes in Parkinson’s Disease (DIGPD) study, a longitudinal cohort study including Parkinson’s disease patients consecutively recruited between 2009 and 2013 at eight French hospitals. All patients had no more than 5 years of disease duration at recruitment, and follow-up included annual evaluations by movement disorder specialists.

At baseline, the majority of patients (302, or 73.5%) had taken dopamine agonists within the past 12 months.

Over the course of 5 years, the prevalence of impulse control disorders increased from 19.7% at baseline to 32.8%, Dr. Corvol and his colleagues reported.

Among 306 patients with no impulse control disorders at baseline, 94 developed one, for a 5-year cumulative incidence of 46.1%, they added. Only 4 of the 94 new cases occurred in patients who never used dopamine agonists.

Dopamine agonist use in the previous 12 months was associated with a 2.23-fold higher prevalence of impulse control disorders (P less than .001), with prevalence increasing along with average daily dose and cumulative dose duration over that time period, according to the investigators.

These findings suggests tools are needed to screen for impulse control disorders and identify high-risk patients, they said.

“Further studies are needed to understand the mechanisms involved in the relation between [dopamine agonists] and [impulse control disorders], in particular the role of apathy, anxiety, and depression,” they added.

The study was funded by grants from the French Ministry of Health and from the French Drug Agency. Dr. Corvol and many of his colleagues reported financial disclosures with many pharmaceutical companies.

SOURCE: Corvol J-C et al. Neurology. 2018 Jun 20. doi: 10.1212/WNL.0000000000005816.

Nearly half of patients with Parkinson’s disease who were taking dopamine agonist treatment experienced impulse control disorders over a follow-up of 5 years, according to recently published results of a longitudinal study.

The 5-year cumulative incidence of impulse control disorders was approximately 45% in the study, which included 411 patients with a high prevalence of dopamine agonist use and disease duration of 5 years or less at baseline.

There was a strong association between dopamine agonist use and impulse control disorders in the study, which was conducted by Jean-Christophe Corvol, MD, of Publique Hôpitaux de Paris and his coinvestigators.

Impulse disorders increased in incidence with both duration and dose of dopamine agonists and resolved progressively after discontinuation of those agents, the investigators reported online June 20 in Neurology. The investigators used item 1.6 of part I of the Movement Disorder Society Unified Parkinson’s Disease Rating Scale to determine the presence of an impulse control disorder.

“Given the high cumulative incidence of impulse control disorders in patients with Parkinson’s disease, these adverse effects should be carefully monitored in patients ever treated with dopamine agonists,” Dr. Corvol and his coauthors wrote.

The results came from the ongoing Drug Interaction With Genes in Parkinson’s Disease (DIGPD) study, a longitudinal cohort study including Parkinson’s disease patients consecutively recruited between 2009 and 2013 at eight French hospitals. All patients had no more than 5 years of disease duration at recruitment, and follow-up included annual evaluations by movement disorder specialists.

At baseline, the majority of patients (302, or 73.5%) had taken dopamine agonists within the past 12 months.

Over the course of 5 years, the prevalence of impulse control disorders increased from 19.7% at baseline to 32.8%, Dr. Corvol and his colleagues reported.

Among 306 patients with no impulse control disorders at baseline, 94 developed one, for a 5-year cumulative incidence of 46.1%, they added. Only 4 of the 94 new cases occurred in patients who never used dopamine agonists.

Dopamine agonist use in the previous 12 months was associated with a 2.23-fold higher prevalence of impulse control disorders (P less than .001), with prevalence increasing along with average daily dose and cumulative dose duration over that time period, according to the investigators.

These findings suggests tools are needed to screen for impulse control disorders and identify high-risk patients, they said.

“Further studies are needed to understand the mechanisms involved in the relation between [dopamine agonists] and [impulse control disorders], in particular the role of apathy, anxiety, and depression,” they added.

The study was funded by grants from the French Ministry of Health and from the French Drug Agency. Dr. Corvol and many of his colleagues reported financial disclosures with many pharmaceutical companies.

SOURCE: Corvol J-C et al. Neurology. 2018 Jun 20. doi: 10.1212/WNL.0000000000005816.

Click here to read Neurology Board Review: Epilepsy

Neurology Board Review: Epilepsy is a resource developed by leading clinical educators for studying for board certification and maintenance of certification exams.

After reading the article, Click Here to Access the Board Review Questions

About the Authors

Shavonne L. Massey, MD
Clinical Instructor
Departments of Neurology and Pediatrics
Children’s Hospital of Philadelphia
University of Pennsylvania
Philadelphia, Pennsylvania

Hannah C. Glass, MDCM, MAS
Associate Professor
Departments of Neurology, Pediatrics, and
Epidemiology & Biostatistics
University of California, San Francisco
San Francisco, California

Click here to read Neurology Board Review: Epilepsy

After reading the article, Click Here to Access the Board Review Questions

Click here to read Neurology Board Review: Epilepsy

Neurology Board Review: Epilepsy is a resource developed by leading clinical educators for studying for board certification and maintenance of certification exams.

After reading the article, Click Here to Access the Board Review Questions

About the Authors

Shavonne L. Massey, MD
Clinical Instructor
Departments of Neurology and Pediatrics
Children’s Hospital of Philadelphia
University of Pennsylvania
Philadelphia, Pennsylvania

Hannah C. Glass, MDCM, MAS
Associate Professor
Departments of Neurology, Pediatrics, and
Epidemiology & Biostatistics
University of California, San Francisco
San Francisco, California

Click here to read Neurology Board Review: Epilepsy

After reading the article, Click Here to Access the Board Review Questions

Click here to read Neurology Board Review: Epilepsy

Neurology Board Review: Epilepsy is a resource developed by leading clinical educators for studying for board certification and maintenance of certification exams.

After reading the article, Click Here to Access the Board Review Questions

About the Authors

Shavonne L. Massey, MD
Clinical Instructor
Departments of Neurology and Pediatrics
Children’s Hospital of Philadelphia
University of Pennsylvania
Philadelphia, Pennsylvania

Hannah C. Glass, MDCM, MAS
Associate Professor
Departments of Neurology, Pediatrics, and
Epidemiology & Biostatistics
University of California, San Francisco
San Francisco, California

Click here to read Neurology Board Review: Epilepsy

After reading the article, Click Here to Access the Board Review Questions

More than 2,000 abstracts will be presented at the annual scientific sessions of the American Diabetes Association in Orlando, from basic science studies to clinical trials. Maureen A. Gannon, PhD, who chairs the Scientific Sessions Meeting Planning Committee, highlighted several as being the most relevant to clinical practice.
 

TEDDY at 13

VADT at 15

Final follow-up data from Veterans Administration Diabetes Trial will be presented on Sunday, June 24, at 4:30 p.m. The trial randomized nearly 2,000 military veterans with poor glycemic control to a mean of 5.6 years of intensive glycemic therapy versus standard treatment, with a goal of lowering HbA1c _{below 8%}.

RISE

Restoring Insulin Secretion (RISE) comprises three intervention trials, two in adults and one in adolescents. The trials are studying whether aggressive glucose lowering will lead to recovery of beta-cell function can be sustained after withdrawal of treatment. Initial results from the adolescent trial will be reported on Monday, June 25, at 2:15 p.m.

SGLT inhibition in type 1 diabetes

Presenters in this session, on Tuesday, June 26 at 10:15 a.m., will provide trial results an insights on a regulatory pathway for sodium-glucose cotransporter (SGLT)-1 and -2 inhibitors in type 1 diabetes patients. Julio Rosenstock, MD, who will present the latest data on empagliflozin from the EASE (Empagliflozin as Adjunctive to InSulin thErapy) trial program, said, “This symposium brings together the lead investigators from the three major competitors that are pursuing approval of a SGLT inhibitor for type 1 diabetes. They will report top-level data that will eventually be submitted to regulators.”

DIY technology

This symposium on Saturday at 1:45 pm, The Diabetes Do-It-Yourself Revolution, will explore the evolving, DIY revolution in diabetes, in which patients are upending traditional treatment pathways and closing their own insulin delivery loop.

“I’m excited about the variety we have in the program this year,” said Dr. Gannon, professor of medicine in the division of diabetes, endocrinology and metabolism; molecular physiology and biophysics; and cell and developmental biology at Vanderbilt University, Nashville, Tenn. “This is the place for cutting-edge information for anybody who is involved in diabetes research or patient care.”
 

More than 2,000 abstracts will be presented at the annual scientific sessions of the American Diabetes Association in Orlando, from basic science studies to clinical trials. Maureen A. Gannon, PhD, who chairs the Scientific Sessions Meeting Planning Committee, highlighted several as being the most relevant to clinical practice.
 

TEDDY at 13

VADT at 15

Final follow-up data from Veterans Administration Diabetes Trial will be presented on Sunday, June 24, at 4:30 p.m. The trial randomized nearly 2,000 military veterans with poor glycemic control to a mean of 5.6 years of intensive glycemic therapy versus standard treatment, with a goal of lowering HbA1c _{below 8%}.

RISE

Restoring Insulin Secretion (RISE) comprises three intervention trials, two in adults and one in adolescents. The trials are studying whether aggressive glucose lowering will lead to recovery of beta-cell function can be sustained after withdrawal of treatment. Initial results from the adolescent trial will be reported on Monday, June 25, at 2:15 p.m.

SGLT inhibition in type 1 diabetes

Presenters in this session, on Tuesday, June 26 at 10:15 a.m., will provide trial results an insights on a regulatory pathway for sodium-glucose cotransporter (SGLT)-1 and -2 inhibitors in type 1 diabetes patients. Julio Rosenstock, MD, who will present the latest data on empagliflozin from the EASE (Empagliflozin as Adjunctive to InSulin thErapy) trial program, said, “This symposium brings together the lead investigators from the three major competitors that are pursuing approval of a SGLT inhibitor for type 1 diabetes. They will report top-level data that will eventually be submitted to regulators.”

DIY technology

This symposium on Saturday at 1:45 pm, The Diabetes Do-It-Yourself Revolution, will explore the evolving, DIY revolution in diabetes, in which patients are upending traditional treatment pathways and closing their own insulin delivery loop.

“I’m excited about the variety we have in the program this year,” said Dr. Gannon, professor of medicine in the division of diabetes, endocrinology and metabolism; molecular physiology and biophysics; and cell and developmental biology at Vanderbilt University, Nashville, Tenn. “This is the place for cutting-edge information for anybody who is involved in diabetes research or patient care.”
 

More than 2,000 abstracts will be presented at the annual scientific sessions of the American Diabetes Association in Orlando, from basic science studies to clinical trials. Maureen A. Gannon, PhD, who chairs the Scientific Sessions Meeting Planning Committee, highlighted several as being the most relevant to clinical practice.
 

TEDDY at 13

VADT at 15

Final follow-up data from Veterans Administration Diabetes Trial will be presented on Sunday, June 24, at 4:30 p.m. The trial randomized nearly 2,000 military veterans with poor glycemic control to a mean of 5.6 years of intensive glycemic therapy versus standard treatment, with a goal of lowering HbA1c _{below 8%}.

RISE

Restoring Insulin Secretion (RISE) comprises three intervention trials, two in adults and one in adolescents. The trials are studying whether aggressive glucose lowering will lead to recovery of beta-cell function can be sustained after withdrawal of treatment. Initial results from the adolescent trial will be reported on Monday, June 25, at 2:15 p.m.

SGLT inhibition in type 1 diabetes

Presenters in this session, on Tuesday, June 26 at 10:15 a.m., will provide trial results an insights on a regulatory pathway for sodium-glucose cotransporter (SGLT)-1 and -2 inhibitors in type 1 diabetes patients. Julio Rosenstock, MD, who will present the latest data on empagliflozin from the EASE (Empagliflozin as Adjunctive to InSulin thErapy) trial program, said, “This symposium brings together the lead investigators from the three major competitors that are pursuing approval of a SGLT inhibitor for type 1 diabetes. They will report top-level data that will eventually be submitted to regulators.”

DIY technology

This symposium on Saturday at 1:45 pm, The Diabetes Do-It-Yourself Revolution, will explore the evolving, DIY revolution in diabetes, in which patients are upending traditional treatment pathways and closing their own insulin delivery loop.

“I’m excited about the variety we have in the program this year,” said Dr. Gannon, professor of medicine in the division of diabetes, endocrinology and metabolism; molecular physiology and biophysics; and cell and developmental biology at Vanderbilt University, Nashville, Tenn. “This is the place for cutting-edge information for anybody who is involved in diabetes research or patient care.”
 

ABSTRACT

Gustilo IIIB injuries of the tibia with segmental bone loss continue to be a difficult reconstructive problem. The serratus anterior-latissimus-rib (SALR) composite flap consists of bone and muscle; this flap can provide soft tissue coverage and vascularized bone in a single surgical procedure. The purpose of this study is to describe the use of the SALR flap for the treatment of a large open tibia fracture with segmental bone loss, with a specific focus on postoperative complications, limb salvage, and time to union.

We reviewed the medical records of patients undergoing an SALR flap (n = 5) for the treatment of Gustilo Type IIIB tibia fractures within 1 month of injury. We compared the mechanism of injury, injury severity score, time from injury to free tissue transfer, complications, and time to radiographic and clinical union.

All patients were male, with a mean age of 25 years. On average, patients underwent free tissue transfer within 1 week of injury. The average time to radiographic union was 7 months. Two patients underwent reoperation. There were no graft failures.

Free SALR flaps can be a useful option for the treatment of high-energy tibia fractures with extensive soft tissue and bone loss. These flaps provide immediate osseous and soft tissue reconstruction with an acceptable complication profile.

Reconstruction of the lower extremity following Gustilo’s grade IIIB injuries is difficult due to loss of both combined soft tissue and segmental bone loss. Since these injuries necessitate the need for soft tissue flap coverage along with vascularized bone grafting, free fibula flaps have classically been used for reconstruction.^1-3 In the setting of bilateral lower extremity injury, the contralateral fibula is often not appropriate to harvest and transfer; therefore, other sources of vascularized bone grafts must be utilized including vascularized iliac crest and rib.^1-5 The vascularized iliac crest graft is insufficient to provide the bony reconstruction of bone defects >6 cm to 7 cm and does not have a reliable skin paddle.⁴ In contrast, free composite serratus anterior-latissimus-rib (SALR) flaps can provide both long segments of vascularized bone and abundant soft tissue coverage for large segmental defects.^1-5

Continue to: Free fibula grafts have been considered...

MATERIALS AND METHODS

Following approval from our Institutional Review Board, we retrospectively reviewed the medical records of patients undergoing a free composite SALR flap (n = 5) for the treatment of a severe open tibia fracture within 1 month of injury. All patients sustained open injuries classified as IIIB on the Gustilo-Anderson scale.¹⁰ Medical records were examined for the mechanism of injury (MOI), injury severity score (ISS), time from injury to free tissue transfer, medical comorbidities, surgical complications, and time to radiographic and clinical union. Radiographic union was determined by the presence of bridging bone on 3 of 4 of cortices on plain film radiographs.

All patients were male (n = 5), with a mean age of 25 years (range, 19-30 years) at the time of injury (Table). 

Table. Demographics and Outcomes of Patients Undergoing Free Tissue Transfer

The MOI included motorcycle collisions (n = 2), pedestrian struck by car (n = 1), motor vehicle collisions (n = 1), and direct blow to the leg (n = 1). The mean ISS of the cohort was 18 (range, 10-34) (Table). On average, patients underwent free tissue transfer within 1 week (range, 3 days to 2 weeks) from the time of injury. Patients in this cohort were followed clinically for a mean of 4 years (range, 1-6 years) after surgery. Patients were non-weight-bearing for an average of 5 months (range, 4-6 months) following their reconstructions.

RESULTS

All flaps survived. The mean time to radiographic and clinical union was 7 months (range, 6-9 months). Two patients underwent reoperation. One patient underwent a bone grafting procedure for a delayed union at 6 months postoperative, and 1 patient underwent irrigation and débridement of superficial soft tissue infection. Donor site complications occurred in 2 patients, including chronic rib pain (n = 1) and a pleural effusion requiring drainage (n = 1). At the last follow-up, all ribs had incorporated, and all patients were weight-bearing as tolerated on the limb.

CASE EXAMPLE

A 22-year-old male smoker was transferred to our facility after a motor vehicle accident with bilateral tibia fractures, 1 closed and 1 open with significant bone loss (Figures 1A, 1B). 

Continue to: Surgical Technique...

SURGICAL TECHNIQUE

The patient is placed in the lateral decubitus position during the procedure. A 2-team approach is used for dissection of the flap and preparation of recipient vessels to decrease operative time. A J-shaped incision is started on the chest at the mid-axillary line and extended just over the fifth and sixth rib. The incision can be made to fall into the intermammary crease in a woman to hide the scar. The dissection begins by exposing the anterior border of the latissimus muscle (Figure 2A). Next, the latissimus is dissected to reveal the thoracodorsal vessels (Figure 2B). At this level, the thoracodorsal vessel can be traced into the axilla. The branch going into the fifth, sixth, and lower slips of the serratus are dissected. The long thoracic nerve and the thoracodorsal nerve are preserved during the dissection (Figure 2C). The fifth, sixth, and seventh slips of the serratus are preferentially included in the dissection while leaving the most superior slips of the serratus to preserve scapular stability. Dissection begins by identifying 2 adjacent rib sections of the fifth and sixth or sixth and seventh ribs. The defect in the lower extremity determines the length of rib harvested. The serratus slips are then divided anteriorly over the chest wall. The dissection is extended to the intercostal spaces of the fourth and fifth ribs. The supraperiosteal dissection is performed at the anterior margin of the rib (Figure 2D). 

Continue to: Following the surgical procedure...

DISCUSSION

High-energy open injuries to the lower extremities are devastating injuries, with a high rate of late amputation and poor functional outcomes.^11-13 Vascularized bone grafting provides both essential osteoinductive and osteoconductive properties to segmental bone defects in areas with inadequate soft tissue coverage, particularly in the setting of >6 cm of bone loss.^4,14 The results of this study show that acute reconstruction of the lower limb with a composite vascularized SALR graft is a reliable procedure with an acceptable complication profile.

The timing of soft tissue coverage should be performed as soon as the patient is medically stable enough to undergo a reconstructive procedure, ideally within 7 to 10 days; and this timetable has been shown to decrease rates of infection and free flap failure.^15-19 Early coverage provides both control of the soft-tissue envelope and reduces the risk of losing bone.¹ Unlike the timing of coverage, the staging of the procedure is controversial. Proponents of the 2-stage free tissue (soft tissue followed by bony flap) transfer feel that although the tissue may not be infected at the time of coverage, it is contaminated with bacteria at the time of bone reconstruction, and as such is at high risk for both infection and complications.²⁰ Unlike 2-stage procedures, single-stage coverage provides immediate soft tissue coverage, as well as bony support. This reduces the time to bony union and negates the need for repeated surgery in a mangled extremity where secondary surgery is complicated by both scar tissue and altered anatomy.^1,2 Furthermore, it has been shown that there is no difference in the rates of infection when performing a single-stage compared with a 2-stage procedure.⁹ In this study, SALR flaps were typically performed within 2 weeks following an injury as a single procedure. We feel this resulted in the low number of complications in the SALR group.

Unlike free fibulas, rib flaps are easily pedicled with an associated soft-tissue flap due to their blood supply, making them ideal for 1-stage reconstruction. The rib has a dual blood supply: 1 from the posterior intercostal artery, and the other, an abundant periosteal blood supply, from the serratus anterior muscle.⁴ The blood supply to the serratus anterior comes from the thoracodorsal artery, and usually provides 14 cm of a large-caliber pedicle, making it a reliable flap for soft tissue reconstruction.^21,22 Another unique feature of the blood supply to this flap is the amount of soft tissue available for both harvest and transfer; larger portions of serratus muscle and latissimus muscle can be harvested if necessary to cover the soft tissue defect.⁴

Comminuted tibias with segmental bone loss are difficult to manage since they are associated with bony as well as soft tissue defects.^1,12,13,23 These injuries are ideal candidates for a single-stage reconstruction using a vascularized SALR flap. In our series, the use of an SALR flap resulted ultimately in a 100% union and limb salvage rate, with no flap failures and a low complication profile. Unlike the SALR, free fibular flaps must be transferred along with a separate latissimus dorsi flap to provide enough soft tissue coverage necessary for reconstructing large Gustilo IIIB injuries, which could increase the risk of flap failure. Since ribs are composed of membranous bone and have a similar cross-sectional area to both metacarpal and metatarsals, there are concerns regarding the biomechanical properties of ribs for weight-bearing.^4,22,24-26 To compensate for this relatively small cross-sectional area, 2 ribs (either consecutive or alternative) are frequently harvested.^1,4,5,23 Previous studies examining the use of ribs for bony reconstruction have frequently supplemented the rib reconstruction to the tibia using screws and external fixation alone.^1,4,5,23 In our series, all SALR grafts were supported with the use of an intramedullary nail (n = 3) or locked plating (n = 1). The use of this supplemental fixation of the SALR graft allowed our patients to return to full weight-bearing (mean, 6 months) much earlier than the length of time cited in previous reports (12 months) examining these injuries.^1,4,5,23

Continue to: There are several limitations...

There are several limitations to this study. The small sample size and retrospective nature of the study limits the amount of data we are able to collect from the medical record and places obvious constraints on the analysis. Although all these procedures were performed at 1 institution, multiple providers were involved in the reconstruction of these injuries, and there is no standard protocol for their treatment. Similarly, although other forms of extremity reconstruction were used during this time period, there was no standard protocol that could serve as a comparator for patients who underwent an SALR compared with other reconstructive procedures.

Overall, SALR grafts provide an excellent option for 1-stage reconstruction of severe, open lower extremity injuries. In this series we noted a 100% graft success rate with an acceptable complication profile.

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

ABSTRACT

Gustilo IIIB injuries of the tibia with segmental bone loss continue to be a difficult reconstructive problem. The serratus anterior-latissimus-rib (SALR) composite flap consists of bone and muscle; this flap can provide soft tissue coverage and vascularized bone in a single surgical procedure. The purpose of this study is to describe the use of the SALR flap for the treatment of a large open tibia fracture with segmental bone loss, with a specific focus on postoperative complications, limb salvage, and time to union.

We reviewed the medical records of patients undergoing an SALR flap (n = 5) for the treatment of Gustilo Type IIIB tibia fractures within 1 month of injury. We compared the mechanism of injury, injury severity score, time from injury to free tissue transfer, complications, and time to radiographic and clinical union.

All patients were male, with a mean age of 25 years. On average, patients underwent free tissue transfer within 1 week of injury. The average time to radiographic union was 7 months. Two patients underwent reoperation. There were no graft failures.

Free SALR flaps can be a useful option for the treatment of high-energy tibia fractures with extensive soft tissue and bone loss. These flaps provide immediate osseous and soft tissue reconstruction with an acceptable complication profile.

Reconstruction of the lower extremity following Gustilo’s grade IIIB injuries is difficult due to loss of both combined soft tissue and segmental bone loss. Since these injuries necessitate the need for soft tissue flap coverage along with vascularized bone grafting, free fibula flaps have classically been used for reconstruction.^1-3 In the setting of bilateral lower extremity injury, the contralateral fibula is often not appropriate to harvest and transfer; therefore, other sources of vascularized bone grafts must be utilized including vascularized iliac crest and rib.^1-5 The vascularized iliac crest graft is insufficient to provide the bony reconstruction of bone defects >6 cm to 7 cm and does not have a reliable skin paddle.⁴ In contrast, free composite serratus anterior-latissimus-rib (SALR) flaps can provide both long segments of vascularized bone and abundant soft tissue coverage for large segmental defects.^1-5

Continue to: Free fibula grafts have been considered...

MATERIALS AND METHODS

Following approval from our Institutional Review Board, we retrospectively reviewed the medical records of patients undergoing a free composite SALR flap (n = 5) for the treatment of a severe open tibia fracture within 1 month of injury. All patients sustained open injuries classified as IIIB on the Gustilo-Anderson scale.¹⁰ Medical records were examined for the mechanism of injury (MOI), injury severity score (ISS), time from injury to free tissue transfer, medical comorbidities, surgical complications, and time to radiographic and clinical union. Radiographic union was determined by the presence of bridging bone on 3 of 4 of cortices on plain film radiographs.

All patients were male (n = 5), with a mean age of 25 years (range, 19-30 years) at the time of injury (Table). 

Table. Demographics and Outcomes of Patients Undergoing Free Tissue Transfer

The MOI included motorcycle collisions (n = 2), pedestrian struck by car (n = 1), motor vehicle collisions (n = 1), and direct blow to the leg (n = 1). The mean ISS of the cohort was 18 (range, 10-34) (Table). On average, patients underwent free tissue transfer within 1 week (range, 3 days to 2 weeks) from the time of injury. Patients in this cohort were followed clinically for a mean of 4 years (range, 1-6 years) after surgery. Patients were non-weight-bearing for an average of 5 months (range, 4-6 months) following their reconstructions.

RESULTS

All flaps survived. The mean time to radiographic and clinical union was 7 months (range, 6-9 months). Two patients underwent reoperation. One patient underwent a bone grafting procedure for a delayed union at 6 months postoperative, and 1 patient underwent irrigation and débridement of superficial soft tissue infection. Donor site complications occurred in 2 patients, including chronic rib pain (n = 1) and a pleural effusion requiring drainage (n = 1). At the last follow-up, all ribs had incorporated, and all patients were weight-bearing as tolerated on the limb.

CASE EXAMPLE

A 22-year-old male smoker was transferred to our facility after a motor vehicle accident with bilateral tibia fractures, 1 closed and 1 open with significant bone loss (Figures 1A, 1B). 

Continue to: Surgical Technique...

SURGICAL TECHNIQUE

The patient is placed in the lateral decubitus position during the procedure. A 2-team approach is used for dissection of the flap and preparation of recipient vessels to decrease operative time. A J-shaped incision is started on the chest at the mid-axillary line and extended just over the fifth and sixth rib. The incision can be made to fall into the intermammary crease in a woman to hide the scar. The dissection begins by exposing the anterior border of the latissimus muscle (Figure 2A). Next, the latissimus is dissected to reveal the thoracodorsal vessels (Figure 2B). At this level, the thoracodorsal vessel can be traced into the axilla. The branch going into the fifth, sixth, and lower slips of the serratus are dissected. The long thoracic nerve and the thoracodorsal nerve are preserved during the dissection (Figure 2C). The fifth, sixth, and seventh slips of the serratus are preferentially included in the dissection while leaving the most superior slips of the serratus to preserve scapular stability. Dissection begins by identifying 2 adjacent rib sections of the fifth and sixth or sixth and seventh ribs. The defect in the lower extremity determines the length of rib harvested. The serratus slips are then divided anteriorly over the chest wall. The dissection is extended to the intercostal spaces of the fourth and fifth ribs. The supraperiosteal dissection is performed at the anterior margin of the rib (Figure 2D). 

Continue to: Following the surgical procedure...

DISCUSSION

High-energy open injuries to the lower extremities are devastating injuries, with a high rate of late amputation and poor functional outcomes.^11-13 Vascularized bone grafting provides both essential osteoinductive and osteoconductive properties to segmental bone defects in areas with inadequate soft tissue coverage, particularly in the setting of >6 cm of bone loss.^4,14 The results of this study show that acute reconstruction of the lower limb with a composite vascularized SALR graft is a reliable procedure with an acceptable complication profile.

The timing of soft tissue coverage should be performed as soon as the patient is medically stable enough to undergo a reconstructive procedure, ideally within 7 to 10 days; and this timetable has been shown to decrease rates of infection and free flap failure.^15-19 Early coverage provides both control of the soft-tissue envelope and reduces the risk of losing bone.¹ Unlike the timing of coverage, the staging of the procedure is controversial. Proponents of the 2-stage free tissue (soft tissue followed by bony flap) transfer feel that although the tissue may not be infected at the time of coverage, it is contaminated with bacteria at the time of bone reconstruction, and as such is at high risk for both infection and complications.²⁰ Unlike 2-stage procedures, single-stage coverage provides immediate soft tissue coverage, as well as bony support. This reduces the time to bony union and negates the need for repeated surgery in a mangled extremity where secondary surgery is complicated by both scar tissue and altered anatomy.^1,2 Furthermore, it has been shown that there is no difference in the rates of infection when performing a single-stage compared with a 2-stage procedure.⁹ In this study, SALR flaps were typically performed within 2 weeks following an injury as a single procedure. We feel this resulted in the low number of complications in the SALR group.

Unlike free fibulas, rib flaps are easily pedicled with an associated soft-tissue flap due to their blood supply, making them ideal for 1-stage reconstruction. The rib has a dual blood supply: 1 from the posterior intercostal artery, and the other, an abundant periosteal blood supply, from the serratus anterior muscle.⁴ The blood supply to the serratus anterior comes from the thoracodorsal artery, and usually provides 14 cm of a large-caliber pedicle, making it a reliable flap for soft tissue reconstruction.^21,22 Another unique feature of the blood supply to this flap is the amount of soft tissue available for both harvest and transfer; larger portions of serratus muscle and latissimus muscle can be harvested if necessary to cover the soft tissue defect.⁴

Comminuted tibias with segmental bone loss are difficult to manage since they are associated with bony as well as soft tissue defects.^1,12,13,23 These injuries are ideal candidates for a single-stage reconstruction using a vascularized SALR flap. In our series, the use of an SALR flap resulted ultimately in a 100% union and limb salvage rate, with no flap failures and a low complication profile. Unlike the SALR, free fibular flaps must be transferred along with a separate latissimus dorsi flap to provide enough soft tissue coverage necessary for reconstructing large Gustilo IIIB injuries, which could increase the risk of flap failure. Since ribs are composed of membranous bone and have a similar cross-sectional area to both metacarpal and metatarsals, there are concerns regarding the biomechanical properties of ribs for weight-bearing.^4,22,24-26 To compensate for this relatively small cross-sectional area, 2 ribs (either consecutive or alternative) are frequently harvested.^1,4,5,23 Previous studies examining the use of ribs for bony reconstruction have frequently supplemented the rib reconstruction to the tibia using screws and external fixation alone.^1,4,5,23 In our series, all SALR grafts were supported with the use of an intramedullary nail (n = 3) or locked plating (n = 1). The use of this supplemental fixation of the SALR graft allowed our patients to return to full weight-bearing (mean, 6 months) much earlier than the length of time cited in previous reports (12 months) examining these injuries.^1,4,5,23

Continue to: There are several limitations...

There are several limitations to this study. The small sample size and retrospective nature of the study limits the amount of data we are able to collect from the medical record and places obvious constraints on the analysis. Although all these procedures were performed at 1 institution, multiple providers were involved in the reconstruction of these injuries, and there is no standard protocol for their treatment. Similarly, although other forms of extremity reconstruction were used during this time period, there was no standard protocol that could serve as a comparator for patients who underwent an SALR compared with other reconstructive procedures.

Overall, SALR grafts provide an excellent option for 1-stage reconstruction of severe, open lower extremity injuries. In this series we noted a 100% graft success rate with an acceptable complication profile.

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

ABSTRACT

Gustilo IIIB injuries of the tibia with segmental bone loss continue to be a difficult reconstructive problem. The serratus anterior-latissimus-rib (SALR) composite flap consists of bone and muscle; this flap can provide soft tissue coverage and vascularized bone in a single surgical procedure. The purpose of this study is to describe the use of the SALR flap for the treatment of a large open tibia fracture with segmental bone loss, with a specific focus on postoperative complications, limb salvage, and time to union.

We reviewed the medical records of patients undergoing an SALR flap (n = 5) for the treatment of Gustilo Type IIIB tibia fractures within 1 month of injury. We compared the mechanism of injury, injury severity score, time from injury to free tissue transfer, complications, and time to radiographic and clinical union.

All patients were male, with a mean age of 25 years. On average, patients underwent free tissue transfer within 1 week of injury. The average time to radiographic union was 7 months. Two patients underwent reoperation. There were no graft failures.

Free SALR flaps can be a useful option for the treatment of high-energy tibia fractures with extensive soft tissue and bone loss. These flaps provide immediate osseous and soft tissue reconstruction with an acceptable complication profile.

Reconstruction of the lower extremity following Gustilo’s grade IIIB injuries is difficult due to loss of both combined soft tissue and segmental bone loss. Since these injuries necessitate the need for soft tissue flap coverage along with vascularized bone grafting, free fibula flaps have classically been used for reconstruction.^1-3 In the setting of bilateral lower extremity injury, the contralateral fibula is often not appropriate to harvest and transfer; therefore, other sources of vascularized bone grafts must be utilized including vascularized iliac crest and rib.^1-5 The vascularized iliac crest graft is insufficient to provide the bony reconstruction of bone defects >6 cm to 7 cm and does not have a reliable skin paddle.⁴ In contrast, free composite serratus anterior-latissimus-rib (SALR) flaps can provide both long segments of vascularized bone and abundant soft tissue coverage for large segmental defects.^1-5

Continue to: Free fibula grafts have been considered...

MATERIALS AND METHODS

Following approval from our Institutional Review Board, we retrospectively reviewed the medical records of patients undergoing a free composite SALR flap (n = 5) for the treatment of a severe open tibia fracture within 1 month of injury. All patients sustained open injuries classified as IIIB on the Gustilo-Anderson scale.¹⁰ Medical records were examined for the mechanism of injury (MOI), injury severity score (ISS), time from injury to free tissue transfer, medical comorbidities, surgical complications, and time to radiographic and clinical union. Radiographic union was determined by the presence of bridging bone on 3 of 4 of cortices on plain film radiographs.

All patients were male (n = 5), with a mean age of 25 years (range, 19-30 years) at the time of injury (Table). 

Table. Demographics and Outcomes of Patients Undergoing Free Tissue Transfer

The MOI included motorcycle collisions (n = 2), pedestrian struck by car (n = 1), motor vehicle collisions (n = 1), and direct blow to the leg (n = 1). The mean ISS of the cohort was 18 (range, 10-34) (Table). On average, patients underwent free tissue transfer within 1 week (range, 3 days to 2 weeks) from the time of injury. Patients in this cohort were followed clinically for a mean of 4 years (range, 1-6 years) after surgery. Patients were non-weight-bearing for an average of 5 months (range, 4-6 months) following their reconstructions.

RESULTS

All flaps survived. The mean time to radiographic and clinical union was 7 months (range, 6-9 months). Two patients underwent reoperation. One patient underwent a bone grafting procedure for a delayed union at 6 months postoperative, and 1 patient underwent irrigation and débridement of superficial soft tissue infection. Donor site complications occurred in 2 patients, including chronic rib pain (n = 1) and a pleural effusion requiring drainage (n = 1). At the last follow-up, all ribs had incorporated, and all patients were weight-bearing as tolerated on the limb.

CASE EXAMPLE

A 22-year-old male smoker was transferred to our facility after a motor vehicle accident with bilateral tibia fractures, 1 closed and 1 open with significant bone loss (Figures 1A, 1B). 

Continue to: Surgical Technique...

SURGICAL TECHNIQUE

The patient is placed in the lateral decubitus position during the procedure. A 2-team approach is used for dissection of the flap and preparation of recipient vessels to decrease operative time. A J-shaped incision is started on the chest at the mid-axillary line and extended just over the fifth and sixth rib. The incision can be made to fall into the intermammary crease in a woman to hide the scar. The dissection begins by exposing the anterior border of the latissimus muscle (Figure 2A). Next, the latissimus is dissected to reveal the thoracodorsal vessels (Figure 2B). At this level, the thoracodorsal vessel can be traced into the axilla. The branch going into the fifth, sixth, and lower slips of the serratus are dissected. The long thoracic nerve and the thoracodorsal nerve are preserved during the dissection (Figure 2C). The fifth, sixth, and seventh slips of the serratus are preferentially included in the dissection while leaving the most superior slips of the serratus to preserve scapular stability. Dissection begins by identifying 2 adjacent rib sections of the fifth and sixth or sixth and seventh ribs. The defect in the lower extremity determines the length of rib harvested. The serratus slips are then divided anteriorly over the chest wall. The dissection is extended to the intercostal spaces of the fourth and fifth ribs. The supraperiosteal dissection is performed at the anterior margin of the rib (Figure 2D). 

Continue to: Following the surgical procedure...

DISCUSSION

High-energy open injuries to the lower extremities are devastating injuries, with a high rate of late amputation and poor functional outcomes.^11-13 Vascularized bone grafting provides both essential osteoinductive and osteoconductive properties to segmental bone defects in areas with inadequate soft tissue coverage, particularly in the setting of >6 cm of bone loss.^4,14 The results of this study show that acute reconstruction of the lower limb with a composite vascularized SALR graft is a reliable procedure with an acceptable complication profile.

The timing of soft tissue coverage should be performed as soon as the patient is medically stable enough to undergo a reconstructive procedure, ideally within 7 to 10 days; and this timetable has been shown to decrease rates of infection and free flap failure.^15-19 Early coverage provides both control of the soft-tissue envelope and reduces the risk of losing bone.¹ Unlike the timing of coverage, the staging of the procedure is controversial. Proponents of the 2-stage free tissue (soft tissue followed by bony flap) transfer feel that although the tissue may not be infected at the time of coverage, it is contaminated with bacteria at the time of bone reconstruction, and as such is at high risk for both infection and complications.²⁰ Unlike 2-stage procedures, single-stage coverage provides immediate soft tissue coverage, as well as bony support. This reduces the time to bony union and negates the need for repeated surgery in a mangled extremity where secondary surgery is complicated by both scar tissue and altered anatomy.^1,2 Furthermore, it has been shown that there is no difference in the rates of infection when performing a single-stage compared with a 2-stage procedure.⁹ In this study, SALR flaps were typically performed within 2 weeks following an injury as a single procedure. We feel this resulted in the low number of complications in the SALR group.

Unlike free fibulas, rib flaps are easily pedicled with an associated soft-tissue flap due to their blood supply, making them ideal for 1-stage reconstruction. The rib has a dual blood supply: 1 from the posterior intercostal artery, and the other, an abundant periosteal blood supply, from the serratus anterior muscle.⁴ The blood supply to the serratus anterior comes from the thoracodorsal artery, and usually provides 14 cm of a large-caliber pedicle, making it a reliable flap for soft tissue reconstruction.^21,22 Another unique feature of the blood supply to this flap is the amount of soft tissue available for both harvest and transfer; larger portions of serratus muscle and latissimus muscle can be harvested if necessary to cover the soft tissue defect.⁴

Comminuted tibias with segmental bone loss are difficult to manage since they are associated with bony as well as soft tissue defects.^1,12,13,23 These injuries are ideal candidates for a single-stage reconstruction using a vascularized SALR flap. In our series, the use of an SALR flap resulted ultimately in a 100% union and limb salvage rate, with no flap failures and a low complication profile. Unlike the SALR, free fibular flaps must be transferred along with a separate latissimus dorsi flap to provide enough soft tissue coverage necessary for reconstructing large Gustilo IIIB injuries, which could increase the risk of flap failure. Since ribs are composed of membranous bone and have a similar cross-sectional area to both metacarpal and metatarsals, there are concerns regarding the biomechanical properties of ribs for weight-bearing.^4,22,24-26 To compensate for this relatively small cross-sectional area, 2 ribs (either consecutive or alternative) are frequently harvested.^1,4,5,23 Previous studies examining the use of ribs for bony reconstruction have frequently supplemented the rib reconstruction to the tibia using screws and external fixation alone.^1,4,5,23 In our series, all SALR grafts were supported with the use of an intramedullary nail (n = 3) or locked plating (n = 1). The use of this supplemental fixation of the SALR graft allowed our patients to return to full weight-bearing (mean, 6 months) much earlier than the length of time cited in previous reports (12 months) examining these injuries.^1,4,5,23

Continue to: There are several limitations...

There are several limitations to this study. The small sample size and retrospective nature of the study limits the amount of data we are able to collect from the medical record and places obvious constraints on the analysis. Although all these procedures were performed at 1 institution, multiple providers were involved in the reconstruction of these injuries, and there is no standard protocol for their treatment. Similarly, although other forms of extremity reconstruction were used during this time period, there was no standard protocol that could serve as a comparator for patients who underwent an SALR compared with other reconstructive procedures.

Overall, SALR grafts provide an excellent option for 1-stage reconstruction of severe, open lower extremity injuries. In this series we noted a 100% graft success rate with an acceptable complication profile.

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