ABSTRACT

Postoperative pain management is an important component of total shoulder arthroplasty (TSA). Continuous cryotherapy (CC) has been proposed as a means of improving postoperative pain control. However, CC represents an increased cost not typically covered by insurance. The purpose of this study is to compare CC to plain ice (ICE) following TSA. The hypothesis was that CC would lead to lower pain scores and decreased narcotic usage during the first 2 weeks postoperatively.

A randomized controlled trial was performed to compare CC to ICE. Forty patients were randomized to receive either CC or ICE following TSA. The rehabilitation and pain control protocols were otherwise standardized. Visual analog scales (VAS) for pain, satisfaction with cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery. Narcotic usage in morphine equivalents was also recorded. 

No significant differences in preoperative pain (5.9 vs 6.8; P = .121), or postoperative pain at 24 hours (4.2 vs 4.3; P = .989), 3 days (4.8 vs 4.7; P = .944), 7 days (2.9 vs 3.3; P = .593) or 14 days (2.5 vs 2.7; P = .742) were observed between the CC and ICE groups. Similarly, no differences in quality of sleep, satisfaction with the cold therapy, or narcotic usage at any time interval were observed between the 2 groups.

No differences in pain control, quality of sleep, patient satisfaction, or narcotic usage were detected between CC and ICE following TSA. CC may offer convenience as an advantage, but the increased cost associated with this type of treatment may not be justified.

The number of total shoulder arthroplasties (TSAs) performed annually is increasing dramatically.¹ At the same time, there has been a push toward decreased length of hospital stay and earlier mobilization following joint replacement surgery. Central to these goals is adequate pain control. Multimodal pain pathways exist, and one of the safest and cheapest methods of pain control is cold therapy, which can be accomplished with continuous cryotherapy (CC) or plain ice (ICE).

Continue to: The mechanism of cryotherapy...

The knee literature contains multiple studies that have examined the benefits of cryotherapy after both arthroscopic and arthroplasty procedures. The clinical benefits on pain have been equivocal with some studies showing improvements using cryotherapy^3,4 and others showing no difference in the treatment group.^5,6

Few studies have examined cryotherapy for the shoulder. Speer and colleagues⁷ demonstrated that postoperative use of CC was effective in reducing recovery time after shoulder surgery. However; they did not provide an ICE comparative group and did not focus specifically on TSA. In another study, Kraeutler and colleagues⁸ examined only arthroscopic shoulder surgery cases in a randomized prospective trial and found no significant different between CC and ICE. They concluded that there did not appear to be a significant benefit in using CC over ICE for arthroscopic shoulder procedures.

The purpose of this study is to prospectively evaluate CC and ICE following TSA. The hypothesis was that CC leads to improved pain control, less narcotic consumption, and improved quality of sleep compared to ICE in the immediate postoperative period following TSA.

MATERIALS AND METHODS

This was a prospective randomized control study of patients undergoing TSA receiving either CC or ICE postoperatively. Institutional Review Board approval was obtained before commencement of the study. Inclusion criteria included patients aged 30 to 90 years old undergoing a primary or revision shoulder arthroplasty procedure between June 2015 and January 2016. Exclusion criteria included hemiarthroplasty procedures.

Continue to: Three patients refused...

Table 1. Summary of Surgical Cases

Abbreviations: CC, continuous cryotherapy; ICE, plain ice; RSA, reverse shoulder arthroplasty; TSA, total shoulder arthroplasty.

All surgeries were performed by Dr. Denard. All patients received a single-shot interscalene nerve block prior to the procedure. A deltopectoral approach was utilized, and the subscapularis was managed with the peel technique.⁹ All patients were admitted to the hospital following surgery. Standard postoperative pain control consisted of as-needed intravenous morphine (1-2 mg every 2 hours, as needed) or an oral narcotic (hydrocodone/acetaminophen 5/325mg, 1-2 every 4 hours, as needed) which was also provided at discharge. However, total narcotic usage was recorded in morphine equivalents to account for substitutions. No non-steroidal anti-inflammatory drugs were allowed until 3 months postoperatively. 

The CC group received treatment from a commercially available cryotherapy unit (Polar Care; Breg). All patients received instructions by a medical professional on how to use the unit. The unit was applied immediately postoperatively and set at a temperature of 45°F to 55°F. Patients were instructed to use the unit continuously during postoperative days 0 to 3. This cryotherapy was administered by a nurse while in the hospital but was left to the responsibility of the patient upon discharge. Patients were instructed to use the unit as needed for pain control during the day and continuously while asleep from days 4 to14. 

The ICE group used standard ice packs postoperatively. The patients were instructed to apply an ice pack for 20 min every 2 hours while awake during days 0 to 3. This therapy was administered by a nurse while in the hospital but left to the responsibility of the patient upon discharge. Patients were instructed to use ice packs as needed for pain control during the day at a maximum of 20 minutes per hour on postoperative days 4 to 14. Compliance by both groups was monitored using a patient survey after hospital discharge. The number of hours that patients used either the CC or ICE per 24-hour period was recorded at 24 hours, 3 days, 7 days, and 14 days. The nursing staff recorded the number of hours of use of either cold modality for each patient prior to hospital discharge. The average length of stay as an inpatient was 1.2 days for the CC group and 1.3 days for the ICE group. 

Visual analog scales (VAS) for pain, satisfaction with the cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery. 

Continue to: The Wilcoxon rank-sum test...

STATISTICAL METHOD

The Wilcoxon rank-sum test was used to assess whether scores changed significantly from the preoperative period to the different postoperative time intervals, as well as to assess the values for pain, quality of sleep, and patient satisfaction. P-values <.05 were considered significant.

RESULTS

No differences were observed in the baseline characteristics between the 2 groups. Both groups showed improvements in pain, quality of sleep, and satisfaction with the cold therapy from the preoperative period to the final follow-up.

The VAS pain scores were not different between the CC and ICE groups preoperatively (5.9 vs 6.8; P = .121) or postoperatively at 24 hours (4.2 vs 4.3; P = .989), 3 days (4.8 vs 4.7; P = .944), 7 days (2.9 vs 3.3; P = .593), or 14 days (2.5 vs 2.7; P = .742).  Both cohorts demonstrated improved overall pain throughout the study period. These findings are summarized in Table 2. 

Table 2. Summary of VAS Pain Scores With Cold Therapy

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice; VAS, visual analog scales.

The number of morphine equivalents of pain medication was not different between the CC and ICE groups postoperatively at 24 hours (43 vs 38 mg; P = .579), 3 days (149 vs 116 mg; P = .201), 7 days (308 vs 228 mg; P = .181), or 14 days (431 vs 348 mg; P = .213). Both groups showed increased narcotic consumption from 24 hours postoperatively until the 2-week follow-up. Narcotic consumption is summarized in Table 3.

Table 3. Summary of Narcotic Consumption in Morphine Equivalents

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice.

VAS for quality of sleep improved in both groups from 24 hours postoperatively until the final follow-up. However, no significant differences in sleep quality were observed between the CC and ICE groups postoperatively at 24 hours (5.1 vs 4.3; P = .382), 3 days (5.1 vs 5.3; P = .601), 7 days (6.0 vs 6.7; P = .319), or 14 days (6.5 vs 7.1; P = .348). The VAS scores for sleep quality are reported in Table 4.

Table 4. Summary of VAS Sleep Quality With Cold Therapy^a

^a0-10 rating with 10 being the highest possible score.

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice; VAS, visual analog scales.

Continue to: Finally, VAS patient satisfaction...

While compliance within each group utilizing the randomly assigned cold modality was similar, the usage by the CC group was consistently higher at all time points recorded. No complications or reoperations were observed in either group.

DISCUSSION

The optimal method for managing postoperative pain from an arthroplasty procedure is controversial. This prospective randomized study attempted to confirm the hypothesis that CC infers better pain control, improves quality of sleep, and decreases narcotic usage compared to ICE in the first 2 weeks after a TSA procedure. The results of this study refuted our hypothesis, demonstrating no significant difference in pain control, satisfaction, narcotic usage, or sleep quality between the CC and ICE cohorts at all time points studied. 

Studies on knees and lower extremities demonstrate equivocal results for the role CC plays in providing improved postoperative pain control. Thienpont¹⁰ evaluated CC in a randomized control trial comparing plain ice packs postoperatively in patients who underwent TKA. The author found no significant difference in VAS for pain or narcotic consumption in morphine equivalents. Thienpont¹⁰ recommended that CC not be used for outpatient knee arthroplasty as it is an additional cost that does not improve pain significantly. Healy and colleagues⁵ reported similar results that CC did not demonstrate a difference in narcotic requirement or pain control compared to plain ice packs, as well as no difference in local postoperative swelling or wound drainage. However, a recently published randomized trial by Su and colleagues¹¹ comparing a cryopneumatic device and ICE with static compression in patients who underwent TKA demonstrated significantly lower narcotic consumption and increased ambulation distances in the treatment group. The treatment group consumed approximately 170 mg morphine equivalents less than the control group between discharge and the 2-week postoperative visit. In addition, a significant difference was observed in the satisfaction scores in the treatment group.¹¹ Similarly, a meta-analysis by Raynor and colleagues¹² on randomized clinical trials comparing cryotherapy to a placebo group after anterior cruciate ligament reconstruction showed that cryotherapy is associated with significantly lower postoperative pain (P = .02), but demonstrated no difference in postoperative drainage (P = .23) or range of motion (P = .25).

Although multiple studies have been published regarding the efficacy of cryotherapy after knee surgery, very few studies have compared CC to conventional ICE after shoulder surgery. A prospective randomized trial was performed by Singh and colleagues¹³ to compare CC vs no ICE in open and arthroscopic shoulder surgery patients. Both the open and arthroscopic groups receiving CC demonstrated significant reductions in pain frequency and more restful sleep at the 7-day, 14-day, and 21-day intervals compared to the control group. However, they did not compare the commercial unit to ICE. In contrast, a study by Kraeutler and colleagues⁸ randomized 46 patients to receive either CC or ICE in the setting of arthroscopic shoulder surgery. Although no significant difference was observed in morphine equivalent dosage between the 2 groups, the CC group used more pain medication on every postoperative day during the first week after surgery. They found no difference between the 2 groups with regards to narcotic consumption or pain scores. The results of this study mirror those by Kraeutler and colleagues,⁸ demonstrating no difference in pain scores, sleep quality, or narcotic consumption.

Continue to: With rising costs in the US...

The major strengths of this study are the randomized design and multiple data points during the early postoperative period. However, there are several limitations. First, we did not objectively measure compliance of either therapy and relied only on a patient survey. Usage of the commercial CC unit in hours decreased over half between days 3 and 14. This occurred despite training on the application and specific instructions. We believe this reflects “real-world” usage, but it is possible that compliance affected our results. Second, all patients in this study had a single-shot interscalene block. While this is standard at our institution, it is possible that either CC or ICE would have a more significant effect in the absence of an interscalene block. Finally, we did not evaluate final outcomes in this study and therefore cannot determine if the final outcome was different between the 2 groups. Our goal was simply to evaluate the first 2 weeks following surgery, as this is the most painful period following TSA. 

CONCLUSION

There was no difference between CC and ICE in terms of pain control, quality of sleep, patient satisfaction, or narcotic consumption following TSA. CC may offer convenience advantages, but the increased cost associated with this type of unit may not be justified. 

ABSTRACT

Postoperative pain management is an important component of total shoulder arthroplasty (TSA). Continuous cryotherapy (CC) has been proposed as a means of improving postoperative pain control. However, CC represents an increased cost not typically covered by insurance. The purpose of this study is to compare CC to plain ice (ICE) following TSA. The hypothesis was that CC would lead to lower pain scores and decreased narcotic usage during the first 2 weeks postoperatively.

A randomized controlled trial was performed to compare CC to ICE. Forty patients were randomized to receive either CC or ICE following TSA. The rehabilitation and pain control protocols were otherwise standardized. Visual analog scales (VAS) for pain, satisfaction with cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery. Narcotic usage in morphine equivalents was also recorded. 

No significant differences in preoperative pain (5.9 vs 6.8; P = .121), or postoperative pain at 24 hours (4.2 vs 4.3; P = .989), 3 days (4.8 vs 4.7; P = .944), 7 days (2.9 vs 3.3; P = .593) or 14 days (2.5 vs 2.7; P = .742) were observed between the CC and ICE groups. Similarly, no differences in quality of sleep, satisfaction with the cold therapy, or narcotic usage at any time interval were observed between the 2 groups.

No differences in pain control, quality of sleep, patient satisfaction, or narcotic usage were detected between CC and ICE following TSA. CC may offer convenience as an advantage, but the increased cost associated with this type of treatment may not be justified.

The number of total shoulder arthroplasties (TSAs) performed annually is increasing dramatically.¹ At the same time, there has been a push toward decreased length of hospital stay and earlier mobilization following joint replacement surgery. Central to these goals is adequate pain control. Multimodal pain pathways exist, and one of the safest and cheapest methods of pain control is cold therapy, which can be accomplished with continuous cryotherapy (CC) or plain ice (ICE).

Continue to: The mechanism of cryotherapy...

The knee literature contains multiple studies that have examined the benefits of cryotherapy after both arthroscopic and arthroplasty procedures. The clinical benefits on pain have been equivocal with some studies showing improvements using cryotherapy^3,4 and others showing no difference in the treatment group.^5,6

Few studies have examined cryotherapy for the shoulder. Speer and colleagues⁷ demonstrated that postoperative use of CC was effective in reducing recovery time after shoulder surgery. However; they did not provide an ICE comparative group and did not focus specifically on TSA. In another study, Kraeutler and colleagues⁸ examined only arthroscopic shoulder surgery cases in a randomized prospective trial and found no significant different between CC and ICE. They concluded that there did not appear to be a significant benefit in using CC over ICE for arthroscopic shoulder procedures.

The purpose of this study is to prospectively evaluate CC and ICE following TSA. The hypothesis was that CC leads to improved pain control, less narcotic consumption, and improved quality of sleep compared to ICE in the immediate postoperative period following TSA.

MATERIALS AND METHODS

This was a prospective randomized control study of patients undergoing TSA receiving either CC or ICE postoperatively. Institutional Review Board approval was obtained before commencement of the study. Inclusion criteria included patients aged 30 to 90 years old undergoing a primary or revision shoulder arthroplasty procedure between June 2015 and January 2016. Exclusion criteria included hemiarthroplasty procedures.

Continue to: Three patients refused...

Table 1. Summary of Surgical Cases

Abbreviations: CC, continuous cryotherapy; ICE, plain ice; RSA, reverse shoulder arthroplasty; TSA, total shoulder arthroplasty.

All surgeries were performed by Dr. Denard. All patients received a single-shot interscalene nerve block prior to the procedure. A deltopectoral approach was utilized, and the subscapularis was managed with the peel technique.⁹ All patients were admitted to the hospital following surgery. Standard postoperative pain control consisted of as-needed intravenous morphine (1-2 mg every 2 hours, as needed) or an oral narcotic (hydrocodone/acetaminophen 5/325mg, 1-2 every 4 hours, as needed) which was also provided at discharge. However, total narcotic usage was recorded in morphine equivalents to account for substitutions. No non-steroidal anti-inflammatory drugs were allowed until 3 months postoperatively. 

The CC group received treatment from a commercially available cryotherapy unit (Polar Care; Breg). All patients received instructions by a medical professional on how to use the unit. The unit was applied immediately postoperatively and set at a temperature of 45°F to 55°F. Patients were instructed to use the unit continuously during postoperative days 0 to 3. This cryotherapy was administered by a nurse while in the hospital but was left to the responsibility of the patient upon discharge. Patients were instructed to use the unit as needed for pain control during the day and continuously while asleep from days 4 to14. 

The ICE group used standard ice packs postoperatively. The patients were instructed to apply an ice pack for 20 min every 2 hours while awake during days 0 to 3. This therapy was administered by a nurse while in the hospital but left to the responsibility of the patient upon discharge. Patients were instructed to use ice packs as needed for pain control during the day at a maximum of 20 minutes per hour on postoperative days 4 to 14. Compliance by both groups was monitored using a patient survey after hospital discharge. The number of hours that patients used either the CC or ICE per 24-hour period was recorded at 24 hours, 3 days, 7 days, and 14 days. The nursing staff recorded the number of hours of use of either cold modality for each patient prior to hospital discharge. The average length of stay as an inpatient was 1.2 days for the CC group and 1.3 days for the ICE group. 

Visual analog scales (VAS) for pain, satisfaction with the cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery. 

Continue to: The Wilcoxon rank-sum test...

STATISTICAL METHOD

The Wilcoxon rank-sum test was used to assess whether scores changed significantly from the preoperative period to the different postoperative time intervals, as well as to assess the values for pain, quality of sleep, and patient satisfaction. P-values <.05 were considered significant.

RESULTS

No differences were observed in the baseline characteristics between the 2 groups. Both groups showed improvements in pain, quality of sleep, and satisfaction with the cold therapy from the preoperative period to the final follow-up.

The VAS pain scores were not different between the CC and ICE groups preoperatively (5.9 vs 6.8; P = .121) or postoperatively at 24 hours (4.2 vs 4.3; P = .989), 3 days (4.8 vs 4.7; P = .944), 7 days (2.9 vs 3.3; P = .593), or 14 days (2.5 vs 2.7; P = .742).  Both cohorts demonstrated improved overall pain throughout the study period. These findings are summarized in Table 2. 

Table 2. Summary of VAS Pain Scores With Cold Therapy

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice; VAS, visual analog scales.

The number of morphine equivalents of pain medication was not different between the CC and ICE groups postoperatively at 24 hours (43 vs 38 mg; P = .579), 3 days (149 vs 116 mg; P = .201), 7 days (308 vs 228 mg; P = .181), or 14 days (431 vs 348 mg; P = .213). Both groups showed increased narcotic consumption from 24 hours postoperatively until the 2-week follow-up. Narcotic consumption is summarized in Table 3.

Table 3. Summary of Narcotic Consumption in Morphine Equivalents

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice.

VAS for quality of sleep improved in both groups from 24 hours postoperatively until the final follow-up. However, no significant differences in sleep quality were observed between the CC and ICE groups postoperatively at 24 hours (5.1 vs 4.3; P = .382), 3 days (5.1 vs 5.3; P = .601), 7 days (6.0 vs 6.7; P = .319), or 14 days (6.5 vs 7.1; P = .348). The VAS scores for sleep quality are reported in Table 4.

Table 4. Summary of VAS Sleep Quality With Cold Therapy^a

^a0-10 rating with 10 being the highest possible score.

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice; VAS, visual analog scales.

Continue to: Finally, VAS patient satisfaction...

While compliance within each group utilizing the randomly assigned cold modality was similar, the usage by the CC group was consistently higher at all time points recorded. No complications or reoperations were observed in either group.

DISCUSSION

The optimal method for managing postoperative pain from an arthroplasty procedure is controversial. This prospective randomized study attempted to confirm the hypothesis that CC infers better pain control, improves quality of sleep, and decreases narcotic usage compared to ICE in the first 2 weeks after a TSA procedure. The results of this study refuted our hypothesis, demonstrating no significant difference in pain control, satisfaction, narcotic usage, or sleep quality between the CC and ICE cohorts at all time points studied. 

Studies on knees and lower extremities demonstrate equivocal results for the role CC plays in providing improved postoperative pain control. Thienpont¹⁰ evaluated CC in a randomized control trial comparing plain ice packs postoperatively in patients who underwent TKA. The author found no significant difference in VAS for pain or narcotic consumption in morphine equivalents. Thienpont¹⁰ recommended that CC not be used for outpatient knee arthroplasty as it is an additional cost that does not improve pain significantly. Healy and colleagues⁵ reported similar results that CC did not demonstrate a difference in narcotic requirement or pain control compared to plain ice packs, as well as no difference in local postoperative swelling or wound drainage. However, a recently published randomized trial by Su and colleagues¹¹ comparing a cryopneumatic device and ICE with static compression in patients who underwent TKA demonstrated significantly lower narcotic consumption and increased ambulation distances in the treatment group. The treatment group consumed approximately 170 mg morphine equivalents less than the control group between discharge and the 2-week postoperative visit. In addition, a significant difference was observed in the satisfaction scores in the treatment group.¹¹ Similarly, a meta-analysis by Raynor and colleagues¹² on randomized clinical trials comparing cryotherapy to a placebo group after anterior cruciate ligament reconstruction showed that cryotherapy is associated with significantly lower postoperative pain (P = .02), but demonstrated no difference in postoperative drainage (P = .23) or range of motion (P = .25).

Although multiple studies have been published regarding the efficacy of cryotherapy after knee surgery, very few studies have compared CC to conventional ICE after shoulder surgery. A prospective randomized trial was performed by Singh and colleagues¹³ to compare CC vs no ICE in open and arthroscopic shoulder surgery patients. Both the open and arthroscopic groups receiving CC demonstrated significant reductions in pain frequency and more restful sleep at the 7-day, 14-day, and 21-day intervals compared to the control group. However, they did not compare the commercial unit to ICE. In contrast, a study by Kraeutler and colleagues⁸ randomized 46 patients to receive either CC or ICE in the setting of arthroscopic shoulder surgery. Although no significant difference was observed in morphine equivalent dosage between the 2 groups, the CC group used more pain medication on every postoperative day during the first week after surgery. They found no difference between the 2 groups with regards to narcotic consumption or pain scores. The results of this study mirror those by Kraeutler and colleagues,⁸ demonstrating no difference in pain scores, sleep quality, or narcotic consumption.

Continue to: With rising costs in the US...

The major strengths of this study are the randomized design and multiple data points during the early postoperative period. However, there are several limitations. First, we did not objectively measure compliance of either therapy and relied only on a patient survey. Usage of the commercial CC unit in hours decreased over half between days 3 and 14. This occurred despite training on the application and specific instructions. We believe this reflects “real-world” usage, but it is possible that compliance affected our results. Second, all patients in this study had a single-shot interscalene block. While this is standard at our institution, it is possible that either CC or ICE would have a more significant effect in the absence of an interscalene block. Finally, we did not evaluate final outcomes in this study and therefore cannot determine if the final outcome was different between the 2 groups. Our goal was simply to evaluate the first 2 weeks following surgery, as this is the most painful period following TSA. 

CONCLUSION

There was no difference between CC and ICE in terms of pain control, quality of sleep, patient satisfaction, or narcotic consumption following TSA. CC may offer convenience advantages, but the increased cost associated with this type of unit may not be justified. 

ABSTRACT

Postoperative pain management is an important component of total shoulder arthroplasty (TSA). Continuous cryotherapy (CC) has been proposed as a means of improving postoperative pain control. However, CC represents an increased cost not typically covered by insurance. The purpose of this study is to compare CC to plain ice (ICE) following TSA. The hypothesis was that CC would lead to lower pain scores and decreased narcotic usage during the first 2 weeks postoperatively.

A randomized controlled trial was performed to compare CC to ICE. Forty patients were randomized to receive either CC or ICE following TSA. The rehabilitation and pain control protocols were otherwise standardized. Visual analog scales (VAS) for pain, satisfaction with cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery. Narcotic usage in morphine equivalents was also recorded. 

No significant differences in preoperative pain (5.9 vs 6.8; P = .121), or postoperative pain at 24 hours (4.2 vs 4.3; P = .989), 3 days (4.8 vs 4.7; P = .944), 7 days (2.9 vs 3.3; P = .593) or 14 days (2.5 vs 2.7; P = .742) were observed between the CC and ICE groups. Similarly, no differences in quality of sleep, satisfaction with the cold therapy, or narcotic usage at any time interval were observed between the 2 groups.

No differences in pain control, quality of sleep, patient satisfaction, or narcotic usage were detected between CC and ICE following TSA. CC may offer convenience as an advantage, but the increased cost associated with this type of treatment may not be justified.

The number of total shoulder arthroplasties (TSAs) performed annually is increasing dramatically.¹ At the same time, there has been a push toward decreased length of hospital stay and earlier mobilization following joint replacement surgery. Central to these goals is adequate pain control. Multimodal pain pathways exist, and one of the safest and cheapest methods of pain control is cold therapy, which can be accomplished with continuous cryotherapy (CC) or plain ice (ICE).

Continue to: The mechanism of cryotherapy...

The knee literature contains multiple studies that have examined the benefits of cryotherapy after both arthroscopic and arthroplasty procedures. The clinical benefits on pain have been equivocal with some studies showing improvements using cryotherapy^3,4 and others showing no difference in the treatment group.^5,6

Few studies have examined cryotherapy for the shoulder. Speer and colleagues⁷ demonstrated that postoperative use of CC was effective in reducing recovery time after shoulder surgery. However; they did not provide an ICE comparative group and did not focus specifically on TSA. In another study, Kraeutler and colleagues⁸ examined only arthroscopic shoulder surgery cases in a randomized prospective trial and found no significant different between CC and ICE. They concluded that there did not appear to be a significant benefit in using CC over ICE for arthroscopic shoulder procedures.

The purpose of this study is to prospectively evaluate CC and ICE following TSA. The hypothesis was that CC leads to improved pain control, less narcotic consumption, and improved quality of sleep compared to ICE in the immediate postoperative period following TSA.

MATERIALS AND METHODS

This was a prospective randomized control study of patients undergoing TSA receiving either CC or ICE postoperatively. Institutional Review Board approval was obtained before commencement of the study. Inclusion criteria included patients aged 30 to 90 years old undergoing a primary or revision shoulder arthroplasty procedure between June 2015 and January 2016. Exclusion criteria included hemiarthroplasty procedures.

Continue to: Three patients refused...

Table 1. Summary of Surgical Cases

Abbreviations: CC, continuous cryotherapy; ICE, plain ice; RSA, reverse shoulder arthroplasty; TSA, total shoulder arthroplasty.

All surgeries were performed by Dr. Denard. All patients received a single-shot interscalene nerve block prior to the procedure. A deltopectoral approach was utilized, and the subscapularis was managed with the peel technique.⁹ All patients were admitted to the hospital following surgery. Standard postoperative pain control consisted of as-needed intravenous morphine (1-2 mg every 2 hours, as needed) or an oral narcotic (hydrocodone/acetaminophen 5/325mg, 1-2 every 4 hours, as needed) which was also provided at discharge. However, total narcotic usage was recorded in morphine equivalents to account for substitutions. No non-steroidal anti-inflammatory drugs were allowed until 3 months postoperatively. 

The CC group received treatment from a commercially available cryotherapy unit (Polar Care; Breg). All patients received instructions by a medical professional on how to use the unit. The unit was applied immediately postoperatively and set at a temperature of 45°F to 55°F. Patients were instructed to use the unit continuously during postoperative days 0 to 3. This cryotherapy was administered by a nurse while in the hospital but was left to the responsibility of the patient upon discharge. Patients were instructed to use the unit as needed for pain control during the day and continuously while asleep from days 4 to14. 

The ICE group used standard ice packs postoperatively. The patients were instructed to apply an ice pack for 20 min every 2 hours while awake during days 0 to 3. This therapy was administered by a nurse while in the hospital but left to the responsibility of the patient upon discharge. Patients were instructed to use ice packs as needed for pain control during the day at a maximum of 20 minutes per hour on postoperative days 4 to 14. Compliance by both groups was monitored using a patient survey after hospital discharge. The number of hours that patients used either the CC or ICE per 24-hour period was recorded at 24 hours, 3 days, 7 days, and 14 days. The nursing staff recorded the number of hours of use of either cold modality for each patient prior to hospital discharge. The average length of stay as an inpatient was 1.2 days for the CC group and 1.3 days for the ICE group. 

Visual analog scales (VAS) for pain, satisfaction with the cold therapy, and quality of sleep were recorded preoperatively and postoperatively at 24 hours, 3 days, 7 days, and 14 days following surgery. 

Continue to: The Wilcoxon rank-sum test...

STATISTICAL METHOD

The Wilcoxon rank-sum test was used to assess whether scores changed significantly from the preoperative period to the different postoperative time intervals, as well as to assess the values for pain, quality of sleep, and patient satisfaction. P-values <.05 were considered significant.

RESULTS

No differences were observed in the baseline characteristics between the 2 groups. Both groups showed improvements in pain, quality of sleep, and satisfaction with the cold therapy from the preoperative period to the final follow-up.

The VAS pain scores were not different between the CC and ICE groups preoperatively (5.9 vs 6.8; P = .121) or postoperatively at 24 hours (4.2 vs 4.3; P = .989), 3 days (4.8 vs 4.7; P = .944), 7 days (2.9 vs 3.3; P = .593), or 14 days (2.5 vs 2.7; P = .742).  Both cohorts demonstrated improved overall pain throughout the study period. These findings are summarized in Table 2. 

Table 2. Summary of VAS Pain Scores With Cold Therapy

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice; VAS, visual analog scales.

The number of morphine equivalents of pain medication was not different between the CC and ICE groups postoperatively at 24 hours (43 vs 38 mg; P = .579), 3 days (149 vs 116 mg; P = .201), 7 days (308 vs 228 mg; P = .181), or 14 days (431 vs 348 mg; P = .213). Both groups showed increased narcotic consumption from 24 hours postoperatively until the 2-week follow-up. Narcotic consumption is summarized in Table 3.

Table 3. Summary of Narcotic Consumption in Morphine Equivalents

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice.

VAS for quality of sleep improved in both groups from 24 hours postoperatively until the final follow-up. However, no significant differences in sleep quality were observed between the CC and ICE groups postoperatively at 24 hours (5.1 vs 4.3; P = .382), 3 days (5.1 vs 5.3; P = .601), 7 days (6.0 vs 6.7; P = .319), or 14 days (6.5 vs 7.1; P = .348). The VAS scores for sleep quality are reported in Table 4.

Table 4. Summary of VAS Sleep Quality With Cold Therapy^a

^a0-10 rating with 10 being the highest possible score.

Abbreviations: CC, continuous cryotherapy; CI, confidence interval; ICE, plain ice; VAS, visual analog scales.

Continue to: Finally, VAS patient satisfaction...

While compliance within each group utilizing the randomly assigned cold modality was similar, the usage by the CC group was consistently higher at all time points recorded. No complications or reoperations were observed in either group.

DISCUSSION

The optimal method for managing postoperative pain from an arthroplasty procedure is controversial. This prospective randomized study attempted to confirm the hypothesis that CC infers better pain control, improves quality of sleep, and decreases narcotic usage compared to ICE in the first 2 weeks after a TSA procedure. The results of this study refuted our hypothesis, demonstrating no significant difference in pain control, satisfaction, narcotic usage, or sleep quality between the CC and ICE cohorts at all time points studied. 

Studies on knees and lower extremities demonstrate equivocal results for the role CC plays in providing improved postoperative pain control. Thienpont¹⁰ evaluated CC in a randomized control trial comparing plain ice packs postoperatively in patients who underwent TKA. The author found no significant difference in VAS for pain or narcotic consumption in morphine equivalents. Thienpont¹⁰ recommended that CC not be used for outpatient knee arthroplasty as it is an additional cost that does not improve pain significantly. Healy and colleagues⁵ reported similar results that CC did not demonstrate a difference in narcotic requirement or pain control compared to plain ice packs, as well as no difference in local postoperative swelling or wound drainage. However, a recently published randomized trial by Su and colleagues¹¹ comparing a cryopneumatic device and ICE with static compression in patients who underwent TKA demonstrated significantly lower narcotic consumption and increased ambulation distances in the treatment group. The treatment group consumed approximately 170 mg morphine equivalents less than the control group between discharge and the 2-week postoperative visit. In addition, a significant difference was observed in the satisfaction scores in the treatment group.¹¹ Similarly, a meta-analysis by Raynor and colleagues¹² on randomized clinical trials comparing cryotherapy to a placebo group after anterior cruciate ligament reconstruction showed that cryotherapy is associated with significantly lower postoperative pain (P = .02), but demonstrated no difference in postoperative drainage (P = .23) or range of motion (P = .25).

Although multiple studies have been published regarding the efficacy of cryotherapy after knee surgery, very few studies have compared CC to conventional ICE after shoulder surgery. A prospective randomized trial was performed by Singh and colleagues¹³ to compare CC vs no ICE in open and arthroscopic shoulder surgery patients. Both the open and arthroscopic groups receiving CC demonstrated significant reductions in pain frequency and more restful sleep at the 7-day, 14-day, and 21-day intervals compared to the control group. However, they did not compare the commercial unit to ICE. In contrast, a study by Kraeutler and colleagues⁸ randomized 46 patients to receive either CC or ICE in the setting of arthroscopic shoulder surgery. Although no significant difference was observed in morphine equivalent dosage between the 2 groups, the CC group used more pain medication on every postoperative day during the first week after surgery. They found no difference between the 2 groups with regards to narcotic consumption or pain scores. The results of this study mirror those by Kraeutler and colleagues,⁸ demonstrating no difference in pain scores, sleep quality, or narcotic consumption.

Continue to: With rising costs in the US...

The major strengths of this study are the randomized design and multiple data points during the early postoperative period. However, there are several limitations. First, we did not objectively measure compliance of either therapy and relied only on a patient survey. Usage of the commercial CC unit in hours decreased over half between days 3 and 14. This occurred despite training on the application and specific instructions. We believe this reflects “real-world” usage, but it is possible that compliance affected our results. Second, all patients in this study had a single-shot interscalene block. While this is standard at our institution, it is possible that either CC or ICE would have a more significant effect in the absence of an interscalene block. Finally, we did not evaluate final outcomes in this study and therefore cannot determine if the final outcome was different between the 2 groups. Our goal was simply to evaluate the first 2 weeks following surgery, as this is the most painful period following TSA. 

CONCLUSION

There was no difference between CC and ICE in terms of pain control, quality of sleep, patient satisfaction, or narcotic consumption following TSA. CC may offer convenience advantages, but the increased cost associated with this type of unit may not be justified. 

A ketogenic diet appears to be effective for children with refractory status epilepticus (RSE) suggests a small trial that included 14 patients.

• A study conducted by the Status Epilepticus Research Group from January 2011 to December 2016 found that 71% of patients with refractory status epilepticus who received a ketogenic diet experienced seizure resolution, verified by EEG findings, within 7 days of starting the regimen.
• 79% of the children with RSE were weaned off enteral infusions of the diet within 14 days.
• Possible adverse effects from the ketogenic diet occurred in 3 of 14 patients, including gastrointestinal paresis and elevated triglyceride levels.
• The regimen produced ketosis within a median of 2 days after it was initiated.
• By 3 months, 4 patients were still seizure free and 3 had fewer seizures.

pediatric Status Epilepticus Research Group (pSERG). Efficacy and safety of ketogenic diet for treatment of pediatric convulsive refractory status epilepticus. Epilepsy Res. 2018;144:1-6.

A ketogenic diet appears to be effective for children with refractory status epilepticus (RSE) suggests a small trial that included 14 patients.

• A study conducted by the Status Epilepticus Research Group from January 2011 to December 2016 found that 71% of patients with refractory status epilepticus who received a ketogenic diet experienced seizure resolution, verified by EEG findings, within 7 days of starting the regimen.
• 79% of the children with RSE were weaned off enteral infusions of the diet within 14 days.
• Possible adverse effects from the ketogenic diet occurred in 3 of 14 patients, including gastrointestinal paresis and elevated triglyceride levels.
• The regimen produced ketosis within a median of 2 days after it was initiated.
• By 3 months, 4 patients were still seizure free and 3 had fewer seizures.

pediatric Status Epilepticus Research Group (pSERG). Efficacy and safety of ketogenic diet for treatment of pediatric convulsive refractory status epilepticus. Epilepsy Res. 2018;144:1-6.

A ketogenic diet appears to be effective for children with refractory status epilepticus (RSE) suggests a small trial that included 14 patients.

• A study conducted by the Status Epilepticus Research Group from January 2011 to December 2016 found that 71% of patients with refractory status epilepticus who received a ketogenic diet experienced seizure resolution, verified by EEG findings, within 7 days of starting the regimen.
• 79% of the children with RSE were weaned off enteral infusions of the diet within 14 days.
• Possible adverse effects from the ketogenic diet occurred in 3 of 14 patients, including gastrointestinal paresis and elevated triglyceride levels.
• The regimen produced ketosis within a median of 2 days after it was initiated.
• By 3 months, 4 patients were still seizure free and 3 had fewer seizures.

pediatric Status Epilepticus Research Group (pSERG). Efficacy and safety of ketogenic diet for treatment of pediatric convulsive refractory status epilepticus. Epilepsy Res. 2018;144:1-6.

The epilepsy associated with focal cortical dysplasia remains a major challenge, but early recognition of the disorder will allow clinicians to consider the possibility of resective surgery, which has been shown to eliminate seizures in some patients.

• A recent review of the medical literature found that most children with focal cortical dysplasia have intractable focal epilepsy.
• The epilepsy observed in patients with focal cortical dysplasia is related to activation of the mTOR pathway and altered receptor neurotransmission.
• The literature review discusses the epidemiology, natural history, and mechanisms that precipitate seizures in children with focal cortical dysplasia.
• Between 25% and 29% of children in a surgical series had focal cortical dysplasia.

Challenges in managing epilepsy associated with focal cortical dysplasia in children. Epilepsy Res. 2018;145:1-17.

The epilepsy associated with focal cortical dysplasia remains a major challenge, but early recognition of the disorder will allow clinicians to consider the possibility of resective surgery, which has been shown to eliminate seizures in some patients.

• A recent review of the medical literature found that most children with focal cortical dysplasia have intractable focal epilepsy.
• The epilepsy observed in patients with focal cortical dysplasia is related to activation of the mTOR pathway and altered receptor neurotransmission.
• The literature review discusses the epidemiology, natural history, and mechanisms that precipitate seizures in children with focal cortical dysplasia.
• Between 25% and 29% of children in a surgical series had focal cortical dysplasia.

Challenges in managing epilepsy associated with focal cortical dysplasia in children. Epilepsy Res. 2018;145:1-17.

The epilepsy associated with focal cortical dysplasia remains a major challenge, but early recognition of the disorder will allow clinicians to consider the possibility of resective surgery, which has been shown to eliminate seizures in some patients.

• A recent review of the medical literature found that most children with focal cortical dysplasia have intractable focal epilepsy.
• The epilepsy observed in patients with focal cortical dysplasia is related to activation of the mTOR pathway and altered receptor neurotransmission.
• The literature review discusses the epidemiology, natural history, and mechanisms that precipitate seizures in children with focal cortical dysplasia.
• Between 25% and 29% of children in a surgical series had focal cortical dysplasia.

Challenges in managing epilepsy associated with focal cortical dysplasia in children. Epilepsy Res. 2018;145:1-17.

Drug therapy for pregnant women with epilepsy has changed markedly in recent years according to analysis of data from the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study.

• MONEAD, an NIH-funded, observational, multicenter study that looked at pregnancy outcomes in mothers and their children, included women ages 14-45 years and up to 20 weeks pregnant.
• Among 351 pregnant women with epilepsy enrolled in the study, 73.8% (259) were on monotherapy and 21.9% (77) on polytherapy; 4% were not taking an antiepileptic drug.
• Lamotrigine was the most popular drug in women on monotherapy, followed by levetiracetam, carbamazepine, zonisamide, oxcarbazepine, and topiramate.
• The most common polypharmacy regimen included  lamotrigine and levetiracetam.

The researchers point out that these percentages only reflect drug usage in US tertiary epilepsy centers and may not indicate usage in community practice.

MONEAD Investigator Group. Changes in antiepileptic drug-prescribing patterns in pregnant women with epilepsy. Epilepsy Behav. 2018;84:10-14.

Drug therapy for pregnant women with epilepsy has changed markedly in recent years according to analysis of data from the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study.

• MONEAD, an NIH-funded, observational, multicenter study that looked at pregnancy outcomes in mothers and their children, included women ages 14-45 years and up to 20 weeks pregnant.
• Among 351 pregnant women with epilepsy enrolled in the study, 73.8% (259) were on monotherapy and 21.9% (77) on polytherapy; 4% were not taking an antiepileptic drug.
• Lamotrigine was the most popular drug in women on monotherapy, followed by levetiracetam, carbamazepine, zonisamide, oxcarbazepine, and topiramate.
• The most common polypharmacy regimen included  lamotrigine and levetiracetam.

The researchers point out that these percentages only reflect drug usage in US tertiary epilepsy centers and may not indicate usage in community practice.

MONEAD Investigator Group. Changes in antiepileptic drug-prescribing patterns in pregnant women with epilepsy. Epilepsy Behav. 2018;84:10-14.

Drug therapy for pregnant women with epilepsy has changed markedly in recent years according to analysis of data from the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study.

• MONEAD, an NIH-funded, observational, multicenter study that looked at pregnancy outcomes in mothers and their children, included women ages 14-45 years and up to 20 weeks pregnant.
• Among 351 pregnant women with epilepsy enrolled in the study, 73.8% (259) were on monotherapy and 21.9% (77) on polytherapy; 4% were not taking an antiepileptic drug.
• Lamotrigine was the most popular drug in women on monotherapy, followed by levetiracetam, carbamazepine, zonisamide, oxcarbazepine, and topiramate.
• The most common polypharmacy regimen included  lamotrigine and levetiracetam.

The researchers point out that these percentages only reflect drug usage in US tertiary epilepsy centers and may not indicate usage in community practice.

MONEAD Investigator Group. Changes in antiepileptic drug-prescribing patterns in pregnant women with epilepsy. Epilepsy Behav. 2018;84:10-14.

SAN DIEGO – Among individuals with a history of injection drug use, more than one-third reported never or sometimes carrying naloxone, while just one in four reported carrying with it them at all times.

Those are key findings from a survey that set out to examine gaps in the naloxone cascade in a sample of people who inject drugs.

“In order to save a life, you have to have the naloxone with you at all times,” lead study author Karin E. Tobin, PhD, said in an interview at the annual meeting of the College on Problems of Drug Dependence.

While emerging research demonstrates the positive impact of opioid overdose education and community naloxone distribution programs to reduce opioid-related overdose deaths, opiate overdose continues to be a major cause of mortality, said Dr. Tobin, who is affiliated with the department of health behavior and society at Johns Hopkins University, Baltimore. “We’ve made a lot of progress in convincing people that naloxone is not addictive, and that it’s not going to cause any harm,” she said. “Now, drug users aren’t afraid to ask for it. Still, we wondered: If everyone knows about naloxone and no one is embarrassed to talk about it, why are people still dying [from opioid overdoses] in Baltimore?”

She and her associates conducted a cross-sectional survey of 353 individuals aged 18 and older in Baltimore who self-reported a lifetime history of injection drug use. The data came from a baseline survey that was conducted as part of a randomized, controlled trial testing the efficacy of a behavioral intervention focused on the Hepatitis C cascade. Individuals were asked to answer questions related to the five steps of the naloxone cascade: awareness (have you ever heard about naloxone?), access (have you ever received naloxone?), training (have you ever been trained to use naloxone?), use (have you ever used naloxone during an opiate overdose?), and possession (how often do you carry naloxone?)

More than half of the survey respondents (65%) were male; mean age was 47 years. For the previous 6 months, more than half of the sample reported the use of crack (64%), heroin (74%), and other injectable drugs (57%), while 90% reported having ever witnessed an overdose – 59% in the prior year alone. Dr. Tobin and her associates found that 90% of respondents had heard about naloxone, 69% had received it, and 60% had been trained to use it. In addition, 37% reported never carrying naloxone, 38% sometimes carried it, 33% said they had used naloxone at some point, and 25% said they always carried it with them.

Doug Brunk/MDedge News

[email protected]

SAN DIEGO – Among individuals with a history of injection drug use, more than one-third reported never or sometimes carrying naloxone, while just one in four reported carrying with it them at all times.

Those are key findings from a survey that set out to examine gaps in the naloxone cascade in a sample of people who inject drugs.

“In order to save a life, you have to have the naloxone with you at all times,” lead study author Karin E. Tobin, PhD, said in an interview at the annual meeting of the College on Problems of Drug Dependence.

While emerging research demonstrates the positive impact of opioid overdose education and community naloxone distribution programs to reduce opioid-related overdose deaths, opiate overdose continues to be a major cause of mortality, said Dr. Tobin, who is affiliated with the department of health behavior and society at Johns Hopkins University, Baltimore. “We’ve made a lot of progress in convincing people that naloxone is not addictive, and that it’s not going to cause any harm,” she said. “Now, drug users aren’t afraid to ask for it. Still, we wondered: If everyone knows about naloxone and no one is embarrassed to talk about it, why are people still dying [from opioid overdoses] in Baltimore?”

She and her associates conducted a cross-sectional survey of 353 individuals aged 18 and older in Baltimore who self-reported a lifetime history of injection drug use. The data came from a baseline survey that was conducted as part of a randomized, controlled trial testing the efficacy of a behavioral intervention focused on the Hepatitis C cascade. Individuals were asked to answer questions related to the five steps of the naloxone cascade: awareness (have you ever heard about naloxone?), access (have you ever received naloxone?), training (have you ever been trained to use naloxone?), use (have you ever used naloxone during an opiate overdose?), and possession (how often do you carry naloxone?)

More than half of the survey respondents (65%) were male; mean age was 47 years. For the previous 6 months, more than half of the sample reported the use of crack (64%), heroin (74%), and other injectable drugs (57%), while 90% reported having ever witnessed an overdose – 59% in the prior year alone. Dr. Tobin and her associates found that 90% of respondents had heard about naloxone, 69% had received it, and 60% had been trained to use it. In addition, 37% reported never carrying naloxone, 38% sometimes carried it, 33% said they had used naloxone at some point, and 25% said they always carried it with them.

Doug Brunk/MDedge News

[email protected]

SAN DIEGO – Among individuals with a history of injection drug use, more than one-third reported never or sometimes carrying naloxone, while just one in four reported carrying with it them at all times.

Those are key findings from a survey that set out to examine gaps in the naloxone cascade in a sample of people who inject drugs.

“In order to save a life, you have to have the naloxone with you at all times,” lead study author Karin E. Tobin, PhD, said in an interview at the annual meeting of the College on Problems of Drug Dependence.

While emerging research demonstrates the positive impact of opioid overdose education and community naloxone distribution programs to reduce opioid-related overdose deaths, opiate overdose continues to be a major cause of mortality, said Dr. Tobin, who is affiliated with the department of health behavior and society at Johns Hopkins University, Baltimore. “We’ve made a lot of progress in convincing people that naloxone is not addictive, and that it’s not going to cause any harm,” she said. “Now, drug users aren’t afraid to ask for it. Still, we wondered: If everyone knows about naloxone and no one is embarrassed to talk about it, why are people still dying [from opioid overdoses] in Baltimore?”

She and her associates conducted a cross-sectional survey of 353 individuals aged 18 and older in Baltimore who self-reported a lifetime history of injection drug use. The data came from a baseline survey that was conducted as part of a randomized, controlled trial testing the efficacy of a behavioral intervention focused on the Hepatitis C cascade. Individuals were asked to answer questions related to the five steps of the naloxone cascade: awareness (have you ever heard about naloxone?), access (have you ever received naloxone?), training (have you ever been trained to use naloxone?), use (have you ever used naloxone during an opiate overdose?), and possession (how often do you carry naloxone?)

More than half of the survey respondents (65%) were male; mean age was 47 years. For the previous 6 months, more than half of the sample reported the use of crack (64%), heroin (74%), and other injectable drugs (57%), while 90% reported having ever witnessed an overdose – 59% in the prior year alone. Dr. Tobin and her associates found that 90% of respondents had heard about naloxone, 69% had received it, and 60% had been trained to use it. In addition, 37% reported never carrying naloxone, 38% sometimes carried it, 33% said they had used naloxone at some point, and 25% said they always carried it with them.

Doug Brunk/MDedge News

[email protected]

SAN DIEGO – Physicians who receive gifts and free meals from opioid manufacturers prescribe more opioids than do their counterparts, a new study suggests.

A sampling of doctors who reported marketing payments or gifts prescribed more of the drugs the following year even as their colleagues prescribed fewer. Researchers also found signs of a dose-effect relationship between more free meals received and more opioid medications prescribed.

The findings, presented at the annual meeting of the College on Problems of Drug Dependence and recently published, do not prove a link between free meals and the massive, deadly opioid epidemic. And the purpose of pharmaceutical marketing, of course, is to persuade physicians to prescribe medications, the researchers noted. The report was published in JAMA Internal Medicine.

Still, in light of the opioid epidemic, “there’s a national effort to reduce overprescribing. Our database suggests that the pharmaceutical industry may be a counterforce,” lead author and pediatrician Scott E. Hadland, MD, MPH, of Boston University, said in an interview.

The findings suggest “it doesn’t take much money to get doctors to potentially prescribe more opioids,” he added.

SOURCE: Hadland SE et al. JAMA Intern Med. 2018 Jun 1;178(6):861-3.

SAN DIEGO – Physicians who receive gifts and free meals from opioid manufacturers prescribe more opioids than do their counterparts, a new study suggests.

A sampling of doctors who reported marketing payments or gifts prescribed more of the drugs the following year even as their colleagues prescribed fewer. Researchers also found signs of a dose-effect relationship between more free meals received and more opioid medications prescribed.

The findings, presented at the annual meeting of the College on Problems of Drug Dependence and recently published, do not prove a link between free meals and the massive, deadly opioid epidemic. And the purpose of pharmaceutical marketing, of course, is to persuade physicians to prescribe medications, the researchers noted. The report was published in JAMA Internal Medicine.

Still, in light of the opioid epidemic, “there’s a national effort to reduce overprescribing. Our database suggests that the pharmaceutical industry may be a counterforce,” lead author and pediatrician Scott E. Hadland, MD, MPH, of Boston University, said in an interview.

The findings suggest “it doesn’t take much money to get doctors to potentially prescribe more opioids,” he added.

SOURCE: Hadland SE et al. JAMA Intern Med. 2018 Jun 1;178(6):861-3.

SAN DIEGO – Physicians who receive gifts and free meals from opioid manufacturers prescribe more opioids than do their counterparts, a new study suggests.

A sampling of doctors who reported marketing payments or gifts prescribed more of the drugs the following year even as their colleagues prescribed fewer. Researchers also found signs of a dose-effect relationship between more free meals received and more opioid medications prescribed.

The findings, presented at the annual meeting of the College on Problems of Drug Dependence and recently published, do not prove a link between free meals and the massive, deadly opioid epidemic. And the purpose of pharmaceutical marketing, of course, is to persuade physicians to prescribe medications, the researchers noted. The report was published in JAMA Internal Medicine.

Still, in light of the opioid epidemic, “there’s a national effort to reduce overprescribing. Our database suggests that the pharmaceutical industry may be a counterforce,” lead author and pediatrician Scott E. Hadland, MD, MPH, of Boston University, said in an interview.

The findings suggest “it doesn’t take much money to get doctors to potentially prescribe more opioids,” he added.

SOURCE: Hadland SE et al. JAMA Intern Med. 2018 Jun 1;178(6):861-3.

©ASCO/Zach Boyden-Holmes 2018

CHICAGO—A specific gene signature might be able to identify patients at risk of CD19 CAR T-cell associated neurotoxicity, according to results of an exploratory analysis presented at the 2018 ASCO Annual Meeting.

The analysis, based on bone marrow samples from patients with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) treated with JCAR015 in the ROCKET trial, helped identify a set of neurotoxicity-associated genes that separated patients based on molecular subtype.

“These findings suggest that patient risk stratification by molecular subtype of disease or gene expression signature may play a role in identifying patients at elevated risk of neurotoxicity,” said Jae Park, MD, of Memorial Sloan Kettering Cancer Center, New York, New York, in a presentation of the findings (abstract 7007).

The phase 2 ROCKET study included adult patients with relapsed or refractory morphological (>5% blasts in bone marrow) CD-19 positive disease in first salvage or greater, including post allogeneic hematopoietic stem cell transplantation (HSCT). Prior blinatumomab was allowed.

The tumor gene expression study presented at ASCO was based on sequenced RNA from pre-apheresis bone marrow samples available for 31 patients in the ROCKET study.

Investigators identified a set of 10 genes expressed more frequently in bone marrow samples from patients in ROCKET with low (grade 0-1) neurotoxicity, and 7 that were more frequent in those who had severe (grade 4-5) neurotoxicity.

Looking at B-cell ALL samples in public datasets by molecular subtype, they found genes highly expressed in the low neurotoxicity ROCKET patients were also highly expressed in Philadelphia chromosome-positive (Ph+) and Ph-like subtypes.

Conversely, the genes highly expressed in the severe neurotoxicity patients were also highly expressed in non-Ph-like samples.

A total of 16 ROCKET patients were classified as having Ph-like gene expression and 15 as having non-Ph-like expression.

There were no grade 4-5 neurotoxicity events in the Ph-like patients, while both grade 3+ and grade 4+ neurotoxicity were significantly more prevalent in the non-Ph-like patients, investigators reported.

One of the most differentially expressed genes in the set was CCL17, which was higher in the low-neurotoxicity tumor samples, and likewise highly expressed in Ph-like B-cell ALL, according to the report.

“[CCL17] may serve as an early biomarker for differentiating severe neurotoxicity,” Dr Park said.

These findings are now being validated in the previously mentioned data set, as well as other studies to see if the findings can be replicated, according to Dr Park.

Juno Therapeutics, a Celgene company, shut down the phase 2 ROCKET trial of JCAR015 in 2017 after 2 clinical holds in 2016 and 5 patient deaths. 

©ASCO/Zach Boyden-Holmes 2018

CHICAGO—A specific gene signature might be able to identify patients at risk of CD19 CAR T-cell associated neurotoxicity, according to results of an exploratory analysis presented at the 2018 ASCO Annual Meeting.

The analysis, based on bone marrow samples from patients with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) treated with JCAR015 in the ROCKET trial, helped identify a set of neurotoxicity-associated genes that separated patients based on molecular subtype.

“These findings suggest that patient risk stratification by molecular subtype of disease or gene expression signature may play a role in identifying patients at elevated risk of neurotoxicity,” said Jae Park, MD, of Memorial Sloan Kettering Cancer Center, New York, New York, in a presentation of the findings (abstract 7007).

The phase 2 ROCKET study included adult patients with relapsed or refractory morphological (>5% blasts in bone marrow) CD-19 positive disease in first salvage or greater, including post allogeneic hematopoietic stem cell transplantation (HSCT). Prior blinatumomab was allowed.

The tumor gene expression study presented at ASCO was based on sequenced RNA from pre-apheresis bone marrow samples available for 31 patients in the ROCKET study.

Investigators identified a set of 10 genes expressed more frequently in bone marrow samples from patients in ROCKET with low (grade 0-1) neurotoxicity, and 7 that were more frequent in those who had severe (grade 4-5) neurotoxicity.

Looking at B-cell ALL samples in public datasets by molecular subtype, they found genes highly expressed in the low neurotoxicity ROCKET patients were also highly expressed in Philadelphia chromosome-positive (Ph+) and Ph-like subtypes.

Conversely, the genes highly expressed in the severe neurotoxicity patients were also highly expressed in non-Ph-like samples.

A total of 16 ROCKET patients were classified as having Ph-like gene expression and 15 as having non-Ph-like expression.

There were no grade 4-5 neurotoxicity events in the Ph-like patients, while both grade 3+ and grade 4+ neurotoxicity were significantly more prevalent in the non-Ph-like patients, investigators reported.

One of the most differentially expressed genes in the set was CCL17, which was higher in the low-neurotoxicity tumor samples, and likewise highly expressed in Ph-like B-cell ALL, according to the report.

“[CCL17] may serve as an early biomarker for differentiating severe neurotoxicity,” Dr Park said.

These findings are now being validated in the previously mentioned data set, as well as other studies to see if the findings can be replicated, according to Dr Park.

Juno Therapeutics, a Celgene company, shut down the phase 2 ROCKET trial of JCAR015 in 2017 after 2 clinical holds in 2016 and 5 patient deaths. 

©ASCO/Zach Boyden-Holmes 2018

CHICAGO—A specific gene signature might be able to identify patients at risk of CD19 CAR T-cell associated neurotoxicity, according to results of an exploratory analysis presented at the 2018 ASCO Annual Meeting.

The analysis, based on bone marrow samples from patients with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) treated with JCAR015 in the ROCKET trial, helped identify a set of neurotoxicity-associated genes that separated patients based on molecular subtype.

“These findings suggest that patient risk stratification by molecular subtype of disease or gene expression signature may play a role in identifying patients at elevated risk of neurotoxicity,” said Jae Park, MD, of Memorial Sloan Kettering Cancer Center, New York, New York, in a presentation of the findings (abstract 7007).

The phase 2 ROCKET study included adult patients with relapsed or refractory morphological (>5% blasts in bone marrow) CD-19 positive disease in first salvage or greater, including post allogeneic hematopoietic stem cell transplantation (HSCT). Prior blinatumomab was allowed.

The tumor gene expression study presented at ASCO was based on sequenced RNA from pre-apheresis bone marrow samples available for 31 patients in the ROCKET study.

Investigators identified a set of 10 genes expressed more frequently in bone marrow samples from patients in ROCKET with low (grade 0-1) neurotoxicity, and 7 that were more frequent in those who had severe (grade 4-5) neurotoxicity.

Looking at B-cell ALL samples in public datasets by molecular subtype, they found genes highly expressed in the low neurotoxicity ROCKET patients were also highly expressed in Philadelphia chromosome-positive (Ph+) and Ph-like subtypes.

Conversely, the genes highly expressed in the severe neurotoxicity patients were also highly expressed in non-Ph-like samples.

A total of 16 ROCKET patients were classified as having Ph-like gene expression and 15 as having non-Ph-like expression.

There were no grade 4-5 neurotoxicity events in the Ph-like patients, while both grade 3+ and grade 4+ neurotoxicity were significantly more prevalent in the non-Ph-like patients, investigators reported.

One of the most differentially expressed genes in the set was CCL17, which was higher in the low-neurotoxicity tumor samples, and likewise highly expressed in Ph-like B-cell ALL, according to the report.

“[CCL17] may serve as an early biomarker for differentiating severe neurotoxicity,” Dr Park said.

These findings are now being validated in the previously mentioned data set, as well as other studies to see if the findings can be replicated, according to Dr Park.

Juno Therapeutics, a Celgene company, shut down the phase 2 ROCKET trial of JCAR015 in 2017 after 2 clinical holds in 2016 and 5 patient deaths. 

Image from NIAID

The US Food and Drug Administrated (FDA) placed a clinical hold on the phase 1 trial of the Sleeping Beauty (SB)-generated CAR T-cell therapy in relapsed or refractory leukemia and lymphoma patients.

The Sleeping Beauty platform was designed to very rapidly manufacture CD19-specific CAR T cells at the point of care.

All SB-CAR T-cell processing is planned to take place within 2 days at the healthcare facility, thus eliminating shipping cells from hospitals to production sites and back again.

The FDA is requesting more chemistry, manufacturing, and control (CMC) information before allowing the trial to proceed.

The Sleeping Beauty technology, a non-viral transposon/transposase system, has the potential to reduce the costs and complexity associated with recombinant viral vector-based immunotherapy, according to developers.

Ziopharm Oncology, Precigen, Inc, a wholly owned subsidiary of Intrexon Corporation, and the University of Texas MD Anderson Cancer Center, are developing the Sleeping Beauty CAR T cell therapy.

“We know what is needed to address the hold issues and are looking forward to responding to the agency in a timely manner,” said Laurence Cooper, MD, PhD, chief executive officer of Ziopharm, in a corporate release.

“We are undertaking cutting-edge science and are on the verge of a paradigm shift based on our approach to very rapidly manufacture CD19-specific T cells within 2 days using our non-viral approach to CAR-T therapy based on the Sleeping Beauty platform.”

The phase 1 trial in question is a third-generation trial in which the CAR T cells are designed to co-express CD19-specific CAR, membrane-bound interleukin 15, and a safety switch.

The findings from earlier generation phase 1 trials have been previously reported in The Journal of Clinical Investigation. 

Image from NIAID

The US Food and Drug Administrated (FDA) placed a clinical hold on the phase 1 trial of the Sleeping Beauty (SB)-generated CAR T-cell therapy in relapsed or refractory leukemia and lymphoma patients.

The Sleeping Beauty platform was designed to very rapidly manufacture CD19-specific CAR T cells at the point of care.

All SB-CAR T-cell processing is planned to take place within 2 days at the healthcare facility, thus eliminating shipping cells from hospitals to production sites and back again.

The FDA is requesting more chemistry, manufacturing, and control (CMC) information before allowing the trial to proceed.

The Sleeping Beauty technology, a non-viral transposon/transposase system, has the potential to reduce the costs and complexity associated with recombinant viral vector-based immunotherapy, according to developers.

Ziopharm Oncology, Precigen, Inc, a wholly owned subsidiary of Intrexon Corporation, and the University of Texas MD Anderson Cancer Center, are developing the Sleeping Beauty CAR T cell therapy.

“We know what is needed to address the hold issues and are looking forward to responding to the agency in a timely manner,” said Laurence Cooper, MD, PhD, chief executive officer of Ziopharm, in a corporate release.

“We are undertaking cutting-edge science and are on the verge of a paradigm shift based on our approach to very rapidly manufacture CD19-specific T cells within 2 days using our non-viral approach to CAR-T therapy based on the Sleeping Beauty platform.”

The phase 1 trial in question is a third-generation trial in which the CAR T cells are designed to co-express CD19-specific CAR, membrane-bound interleukin 15, and a safety switch.

The findings from earlier generation phase 1 trials have been previously reported in The Journal of Clinical Investigation. 

Image from NIAID

The US Food and Drug Administrated (FDA) placed a clinical hold on the phase 1 trial of the Sleeping Beauty (SB)-generated CAR T-cell therapy in relapsed or refractory leukemia and lymphoma patients.

The Sleeping Beauty platform was designed to very rapidly manufacture CD19-specific CAR T cells at the point of care.

All SB-CAR T-cell processing is planned to take place within 2 days at the healthcare facility, thus eliminating shipping cells from hospitals to production sites and back again.

The FDA is requesting more chemistry, manufacturing, and control (CMC) information before allowing the trial to proceed.

The Sleeping Beauty technology, a non-viral transposon/transposase system, has the potential to reduce the costs and complexity associated with recombinant viral vector-based immunotherapy, according to developers.

Ziopharm Oncology, Precigen, Inc, a wholly owned subsidiary of Intrexon Corporation, and the University of Texas MD Anderson Cancer Center, are developing the Sleeping Beauty CAR T cell therapy.

“We know what is needed to address the hold issues and are looking forward to responding to the agency in a timely manner,” said Laurence Cooper, MD, PhD, chief executive officer of Ziopharm, in a corporate release.

“We are undertaking cutting-edge science and are on the verge of a paradigm shift based on our approach to very rapidly manufacture CD19-specific T cells within 2 days using our non-viral approach to CAR-T therapy based on the Sleeping Beauty platform.”

The phase 1 trial in question is a third-generation trial in which the CAR T cells are designed to co-express CD19-specific CAR, membrane-bound interleukin 15, and a safety switch.

The findings from earlier generation phase 1 trials have been previously reported in The Journal of Clinical Investigation. 

A case of inflammatory myopathy in an immunosuppressed patient who received a tattoo highlights a possible risk of tattooing in people with a compromised immune system.

Writing in the June 18 online edition of BMJ Case Reports, clinicians described a 31-year-old woman who was on long-term immunosuppressive therapy after bilateral lung transplants for cystic fibrosis.

The woman received a large, colored tattoo on her upper leg, with no immediate complications beyond the usual mild skin irritation. However, 9 days later, she developed pain in her left thigh and knee that was severe enough to require analgesic treatment that included tramadol and paracetamol.

The pain settled over the following few months, but the woman continued to experience a sense of fullness from her hip to knee along the medial side of her thigh. She presented to a rheumatology clinic 10 months after she was tattooed, with pain that was still constant and disturbing her sleep, but with no apparent aggravating factors and, otherwise, she was in good health.

Work-up included an MRI that showed focal inflammation of the vastus medialis muscle, particularly in the distal third, but a biopsy found no bacterial growth, nor was there any bacterial or fungal infection found in fluid drawn from the knee. However, histopathology revealed scattered internal nuclei, atrophic fibers, a mild perivascular inflammatory infiltrate, and upregulation of human leukocyte antigen.

In the report, William T. Wilson, MD, and his colleagues from the department of trauma and orthopedics, NHS Greater Glasgow and Clyde, Glasgow, said that these findings gave the impression of an inflammatory myopathy in which the pathologic response may have been influenced by the immunosuppression.

“To our knowledge, there have been no previously reported cases of tattoo-associated reactions causing an inflammatory myopathy,” they wrote. “This could be a rare occurrence or represent an underdiagnosis for patients presenting with similar symptoms having had tattoos.”

The authors suggested there was a chance that the myopathy may have been stimulated by a toxin or pathogen introduced during tattoo procedure. However, they pointed out that they could not identify a causative pathogen, although the timing of onset and location of symptoms correlated with the tattoo application.

“This case serves as a reminder to consider tattoo-related complications as part of the differential diagnosis when patients, especially the immune-suppressed, present with unusual atraumatic musculoskeletal symptoms,” they wrote.

After the biopsy, the woman received physiotherapy in the form of basic quadriceps-strengthening exercises. Her condition did not start to improve until about 1 year after the onset of symptoms, and by 3 years, she had no more pain and had resumed normal activities.

No funding or conflicts of interest were declared.

SOURCE: Wilson W et al. BMJ Case Rep. 2018. Jun 18. doi: 10.1136/bcr-2018-224968.

A case of inflammatory myopathy in an immunosuppressed patient who received a tattoo highlights a possible risk of tattooing in people with a compromised immune system.

Writing in the June 18 online edition of BMJ Case Reports, clinicians described a 31-year-old woman who was on long-term immunosuppressive therapy after bilateral lung transplants for cystic fibrosis.

The woman received a large, colored tattoo on her upper leg, with no immediate complications beyond the usual mild skin irritation. However, 9 days later, she developed pain in her left thigh and knee that was severe enough to require analgesic treatment that included tramadol and paracetamol.

The pain settled over the following few months, but the woman continued to experience a sense of fullness from her hip to knee along the medial side of her thigh. She presented to a rheumatology clinic 10 months after she was tattooed, with pain that was still constant and disturbing her sleep, but with no apparent aggravating factors and, otherwise, she was in good health.

Work-up included an MRI that showed focal inflammation of the vastus medialis muscle, particularly in the distal third, but a biopsy found no bacterial growth, nor was there any bacterial or fungal infection found in fluid drawn from the knee. However, histopathology revealed scattered internal nuclei, atrophic fibers, a mild perivascular inflammatory infiltrate, and upregulation of human leukocyte antigen.

In the report, William T. Wilson, MD, and his colleagues from the department of trauma and orthopedics, NHS Greater Glasgow and Clyde, Glasgow, said that these findings gave the impression of an inflammatory myopathy in which the pathologic response may have been influenced by the immunosuppression.

“To our knowledge, there have been no previously reported cases of tattoo-associated reactions causing an inflammatory myopathy,” they wrote. “This could be a rare occurrence or represent an underdiagnosis for patients presenting with similar symptoms having had tattoos.”

The authors suggested there was a chance that the myopathy may have been stimulated by a toxin or pathogen introduced during tattoo procedure. However, they pointed out that they could not identify a causative pathogen, although the timing of onset and location of symptoms correlated with the tattoo application.

“This case serves as a reminder to consider tattoo-related complications as part of the differential diagnosis when patients, especially the immune-suppressed, present with unusual atraumatic musculoskeletal symptoms,” they wrote.

After the biopsy, the woman received physiotherapy in the form of basic quadriceps-strengthening exercises. Her condition did not start to improve until about 1 year after the onset of symptoms, and by 3 years, she had no more pain and had resumed normal activities.

No funding or conflicts of interest were declared.

SOURCE: Wilson W et al. BMJ Case Rep. 2018. Jun 18. doi: 10.1136/bcr-2018-224968.

A case of inflammatory myopathy in an immunosuppressed patient who received a tattoo highlights a possible risk of tattooing in people with a compromised immune system.

Writing in the June 18 online edition of BMJ Case Reports, clinicians described a 31-year-old woman who was on long-term immunosuppressive therapy after bilateral lung transplants for cystic fibrosis.

The woman received a large, colored tattoo on her upper leg, with no immediate complications beyond the usual mild skin irritation. However, 9 days later, she developed pain in her left thigh and knee that was severe enough to require analgesic treatment that included tramadol and paracetamol.

The pain settled over the following few months, but the woman continued to experience a sense of fullness from her hip to knee along the medial side of her thigh. She presented to a rheumatology clinic 10 months after she was tattooed, with pain that was still constant and disturbing her sleep, but with no apparent aggravating factors and, otherwise, she was in good health.

Work-up included an MRI that showed focal inflammation of the vastus medialis muscle, particularly in the distal third, but a biopsy found no bacterial growth, nor was there any bacterial or fungal infection found in fluid drawn from the knee. However, histopathology revealed scattered internal nuclei, atrophic fibers, a mild perivascular inflammatory infiltrate, and upregulation of human leukocyte antigen.

In the report, William T. Wilson, MD, and his colleagues from the department of trauma and orthopedics, NHS Greater Glasgow and Clyde, Glasgow, said that these findings gave the impression of an inflammatory myopathy in which the pathologic response may have been influenced by the immunosuppression.

“To our knowledge, there have been no previously reported cases of tattoo-associated reactions causing an inflammatory myopathy,” they wrote. “This could be a rare occurrence or represent an underdiagnosis for patients presenting with similar symptoms having had tattoos.”

The authors suggested there was a chance that the myopathy may have been stimulated by a toxin or pathogen introduced during tattoo procedure. However, they pointed out that they could not identify a causative pathogen, although the timing of onset and location of symptoms correlated with the tattoo application.

“This case serves as a reminder to consider tattoo-related complications as part of the differential diagnosis when patients, especially the immune-suppressed, present with unusual atraumatic musculoskeletal symptoms,” they wrote.

After the biopsy, the woman received physiotherapy in the form of basic quadriceps-strengthening exercises. Her condition did not start to improve until about 1 year after the onset of symptoms, and by 3 years, she had no more pain and had resumed normal activities.

No funding or conflicts of interest were declared.

SOURCE: Wilson W et al. BMJ Case Rep. 2018. Jun 18. doi: 10.1136/bcr-2018-224968.

Rural cancer survivors reported more timely care than did urban cancer survivors in a survey of 6,826 Medicare beneficiaries.

Taken as a whole, a similar quality of care was reported between the two groups, but the picture changed when racial/ethnic subgroups were considered. Non-Hispanic black and Hispanic patients in rural locations reported inferior care to their urban counterparts, investigators wrote in Cancer.

“Cancer patients living in rural areas are vulnerable and have unique health care needs,” wrote lead author Michelle A. Mollica, PhD, of the National Cancer Institute, and her colleagues. “To our knowledge, this is the first study to explore the patient’s perception of the timeliness of care in such a large, multiregion sample of cancer patients.”

In 2003, the National Academy of Medicine concluded that living in a rural environment was associated with poorer health. Existing research surrounding cancer has echoed this concern, showing that rural patients have higher rates of cancer and mortality, longer delays in diagnosis, and limited access to care.

The current, retrospective study involved 6,140 urban and 686 rural Medicare beneficiaries who were aged at least 65 years when diagnosed with either breast, lung, colorectal, or prostate cancer. Consumer Assessment of Healthcare Providers and Systems surveys were conducted between 1998 and 2013, then linked with data from the Surveillance, Epidemiology, and End Results registry program.

Surveys were conducted within 12 months of diagnosis, during which time patients were asked about their access to care as defined by two composites: “Getting Needed Care” and “Getting Care Quickly.” Getting Needed Care included ease of making appointments and receiving treatments and Getting Care Quickly questions asked about appointment delays and time spent waiting at the doctor’s office. Answers were converted to a numerical score from 0 to 100, with 0 being the worst and 100 being the best.

For both composites, mean scores for urban and rural locations were greater than 85 out of 100.

In contrast to previous studies, urban patients reported longer delays in care, scoring Getting Care Quickly 2.27 points lower than rural patients (P = .02). Pacific Islanders and non-Hispanic Asian patients from rural places reported even faster care, ranking about 8 points higher than urban patients of the same race/ethnicity.

Locality did not have a significant impact on Getting Needed Care unless race/ethnicity was also considered (P = .04). Non-Hispanic white patients from rural locations scored Getting Needed Care about 2 points higher than urban white patients, while Hispanic and non-Hispanic black patients had an opposite trend, with this rural cohort ranking Getting Needed Care lower than urban patients of the same race/ethnicity.

“Geographic residence is but one important factor in cancer care delivery,” the authors noted. “There is a need for fine-grained research looking at specific barriers for urban residents, experiences of racial/ethnic minority survivors residing in rural areas, and rural-urban differences in the clinic settings in which medical care is delivered.”

The authors had no disclosures to report.

SOURCE: Mollica MA et al. Cancer. 2018 Jun 7. doi: 10.1002/cncr.31541.

Rural cancer survivors reported more timely care than did urban cancer survivors in a survey of 6,826 Medicare beneficiaries.

Taken as a whole, a similar quality of care was reported between the two groups, but the picture changed when racial/ethnic subgroups were considered. Non-Hispanic black and Hispanic patients in rural locations reported inferior care to their urban counterparts, investigators wrote in Cancer.

“Cancer patients living in rural areas are vulnerable and have unique health care needs,” wrote lead author Michelle A. Mollica, PhD, of the National Cancer Institute, and her colleagues. “To our knowledge, this is the first study to explore the patient’s perception of the timeliness of care in such a large, multiregion sample of cancer patients.”

In 2003, the National Academy of Medicine concluded that living in a rural environment was associated with poorer health. Existing research surrounding cancer has echoed this concern, showing that rural patients have higher rates of cancer and mortality, longer delays in diagnosis, and limited access to care.

The current, retrospective study involved 6,140 urban and 686 rural Medicare beneficiaries who were aged at least 65 years when diagnosed with either breast, lung, colorectal, or prostate cancer. Consumer Assessment of Healthcare Providers and Systems surveys were conducted between 1998 and 2013, then linked with data from the Surveillance, Epidemiology, and End Results registry program.

Surveys were conducted within 12 months of diagnosis, during which time patients were asked about their access to care as defined by two composites: “Getting Needed Care” and “Getting Care Quickly.” Getting Needed Care included ease of making appointments and receiving treatments and Getting Care Quickly questions asked about appointment delays and time spent waiting at the doctor’s office. Answers were converted to a numerical score from 0 to 100, with 0 being the worst and 100 being the best.

For both composites, mean scores for urban and rural locations were greater than 85 out of 100.

In contrast to previous studies, urban patients reported longer delays in care, scoring Getting Care Quickly 2.27 points lower than rural patients (P = .02). Pacific Islanders and non-Hispanic Asian patients from rural places reported even faster care, ranking about 8 points higher than urban patients of the same race/ethnicity.

Locality did not have a significant impact on Getting Needed Care unless race/ethnicity was also considered (P = .04). Non-Hispanic white patients from rural locations scored Getting Needed Care about 2 points higher than urban white patients, while Hispanic and non-Hispanic black patients had an opposite trend, with this rural cohort ranking Getting Needed Care lower than urban patients of the same race/ethnicity.

“Geographic residence is but one important factor in cancer care delivery,” the authors noted. “There is a need for fine-grained research looking at specific barriers for urban residents, experiences of racial/ethnic minority survivors residing in rural areas, and rural-urban differences in the clinic settings in which medical care is delivered.”

The authors had no disclosures to report.

SOURCE: Mollica MA et al. Cancer. 2018 Jun 7. doi: 10.1002/cncr.31541.

Rural cancer survivors reported more timely care than did urban cancer survivors in a survey of 6,826 Medicare beneficiaries.

Taken as a whole, a similar quality of care was reported between the two groups, but the picture changed when racial/ethnic subgroups were considered. Non-Hispanic black and Hispanic patients in rural locations reported inferior care to their urban counterparts, investigators wrote in Cancer.

“Cancer patients living in rural areas are vulnerable and have unique health care needs,” wrote lead author Michelle A. Mollica, PhD, of the National Cancer Institute, and her colleagues. “To our knowledge, this is the first study to explore the patient’s perception of the timeliness of care in such a large, multiregion sample of cancer patients.”

In 2003, the National Academy of Medicine concluded that living in a rural environment was associated with poorer health. Existing research surrounding cancer has echoed this concern, showing that rural patients have higher rates of cancer and mortality, longer delays in diagnosis, and limited access to care.

The current, retrospective study involved 6,140 urban and 686 rural Medicare beneficiaries who were aged at least 65 years when diagnosed with either breast, lung, colorectal, or prostate cancer. Consumer Assessment of Healthcare Providers and Systems surveys were conducted between 1998 and 2013, then linked with data from the Surveillance, Epidemiology, and End Results registry program.

Surveys were conducted within 12 months of diagnosis, during which time patients were asked about their access to care as defined by two composites: “Getting Needed Care” and “Getting Care Quickly.” Getting Needed Care included ease of making appointments and receiving treatments and Getting Care Quickly questions asked about appointment delays and time spent waiting at the doctor’s office. Answers were converted to a numerical score from 0 to 100, with 0 being the worst and 100 being the best.

For both composites, mean scores for urban and rural locations were greater than 85 out of 100.

In contrast to previous studies, urban patients reported longer delays in care, scoring Getting Care Quickly 2.27 points lower than rural patients (P = .02). Pacific Islanders and non-Hispanic Asian patients from rural places reported even faster care, ranking about 8 points higher than urban patients of the same race/ethnicity.

Locality did not have a significant impact on Getting Needed Care unless race/ethnicity was also considered (P = .04). Non-Hispanic white patients from rural locations scored Getting Needed Care about 2 points higher than urban white patients, while Hispanic and non-Hispanic black patients had an opposite trend, with this rural cohort ranking Getting Needed Care lower than urban patients of the same race/ethnicity.

“Geographic residence is but one important factor in cancer care delivery,” the authors noted. “There is a need for fine-grained research looking at specific barriers for urban residents, experiences of racial/ethnic minority survivors residing in rural areas, and rural-urban differences in the clinic settings in which medical care is delivered.”

The authors had no disclosures to report.

SOURCE: Mollica MA et al. Cancer. 2018 Jun 7. doi: 10.1002/cncr.31541.