Poliovirus vaccinations for children in the United States who may have been vaccinated elsewhere must meet Advisory Committee on Immunization Practices recommendations to ensure protection against all three poliovirus types, according to guidance published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

Although the United States continues to use an inactivated polio vaccine (IPV) that contains all three types, other countries using an oral polio vaccine (OPV) switched from a trivalent oral poliovirus vaccine (tOPV) to a bivalent version (bOPV) after the World Health Organization declared type 2 polio virus eradicated in September 2015.

designer491/Thinkstock

Poliovirus vaccinations for children in the United States who may have been vaccinated elsewhere must meet Advisory Committee on Immunization Practices recommendations to ensure protection against all three poliovirus types, according to guidance published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

Although the United States continues to use an inactivated polio vaccine (IPV) that contains all three types, other countries using an oral polio vaccine (OPV) switched from a trivalent oral poliovirus vaccine (tOPV) to a bivalent version (bOPV) after the World Health Organization declared type 2 polio virus eradicated in September 2015.

designer491/Thinkstock

Poliovirus vaccinations for children in the United States who may have been vaccinated elsewhere must meet Advisory Committee on Immunization Practices recommendations to ensure protection against all three poliovirus types, according to guidance published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

Although the United States continues to use an inactivated polio vaccine (IPV) that contains all three types, other countries using an oral polio vaccine (OPV) switched from a trivalent oral poliovirus vaccine (tOPV) to a bivalent version (bOPV) after the World Health Organization declared type 2 polio virus eradicated in September 2015.

designer491/Thinkstock

VIENNA – Several different tests for PD-L1 levels in tumor cells of patients with metastatic non–small cell lung cancer showed high concordance when run at seven French centers, boosting confidence in the clinical utility of this testing to guide first-line pembrolizumab treatment of patients with this cancer.

Among 27 laboratory-developed tests for PD-L1 (programmed death–ligand 1) levels in tumor cells that used any one of three prespecified testing platforms (made by Dako, Ventana, or Leica), 14 (52%) had “similar” concordance when compared with reference assays, Julien Adam, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer. “These results will provide the basis for making national recommendations for PD-L1 testing in patients with non–small cell lung cancer [NSCLC]” in France, added Dr. Adam, a pathologist at Gustave Roussy Cancer Center in Paris. “We expect to produce recommendations by the second half of 2017.”

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

VIENNA – Several different tests for PD-L1 levels in tumor cells of patients with metastatic non–small cell lung cancer showed high concordance when run at seven French centers, boosting confidence in the clinical utility of this testing to guide first-line pembrolizumab treatment of patients with this cancer.

Among 27 laboratory-developed tests for PD-L1 (programmed death–ligand 1) levels in tumor cells that used any one of three prespecified testing platforms (made by Dako, Ventana, or Leica), 14 (52%) had “similar” concordance when compared with reference assays, Julien Adam, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer. “These results will provide the basis for making national recommendations for PD-L1 testing in patients with non–small cell lung cancer [NSCLC]” in France, added Dr. Adam, a pathologist at Gustave Roussy Cancer Center in Paris. “We expect to produce recommendations by the second half of 2017.”

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

VIENNA – Several different tests for PD-L1 levels in tumor cells of patients with metastatic non–small cell lung cancer showed high concordance when run at seven French centers, boosting confidence in the clinical utility of this testing to guide first-line pembrolizumab treatment of patients with this cancer.

Among 27 laboratory-developed tests for PD-L1 (programmed death–ligand 1) levels in tumor cells that used any one of three prespecified testing platforms (made by Dako, Ventana, or Leica), 14 (52%) had “similar” concordance when compared with reference assays, Julien Adam, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer. “These results will provide the basis for making national recommendations for PD-L1 testing in patients with non–small cell lung cancer [NSCLC]” in France, added Dr. Adam, a pathologist at Gustave Roussy Cancer Center in Paris. “We expect to produce recommendations by the second half of 2017.”

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

SAN DIEGO – Patients with chronic lymphocytic leukemia at risk for early relapse were about 85% less likely to progress on lenalidomide maintenance therapy compared with placebo, based on an interim analysis of the randomized phase III CLLM1 study.

After a typical follow-up time of 17.5 months, median durations of progression-free survival were not reached with lenalidomide and were 13 months with placebo, for a hazard ratio of 0.15 (95% confidence interval, 0.06-0.35). These results were “statistically significant, robust, and reliable in favor of lenalidomide,” Anna Fink, MD, said at the 2016 meeting of the American Society of Hematology. Several patients in the lenalidomide arm also converted to minimal residual disease (MRD) negativity, added Dr. Fink of University Hospital Cologne (Germany).

The study included patients whose CLL responded at least partially to front-line chemoimmunotherapy, but who were at high risk of progression – minimal residual disease levels were at least 10^–2, or were between 10^–4 and 10^–2 in patients who also had an unmutated IGHV gene status or del(17p) or TP53 mutations at baseline. Among 89 patients who met these criteria, 60 received lenalidomide maintenance and 20 received placebo.

The initial lenalidomide cycle consisted of 5 mg daily for 28 days. To achieve MRD negativity, clinicians increased this dose during subsequent cycles to a maximum of 15 mg daily for patients who were MRD negative after cycle 12, 20 mg for patients who were MRD negative after cycle 18, and 25 mg for patients who remained MRD positive. Median age was 64 years, more than 80% of patients were male, and the median cumulative illness rating was relatively low at 2, ranging between 0 and 8.

A total of 37% of patients had a high MRD level and 63% had an intermediate level. For both cohorts, lenalidomide maintenance significantly prolonged progression-free survival, compared with placebo, with hazard ratios of 0.17 and 0.13, respectively. Patients received a median of 11 and up to 40 cycles of lenalidomide, but a median of only 8 cycles of placebo.

In all, 43% of lenalidomide patients and 72% of placebo patients stopped maintenance. Nearly a third of those who discontinued lenalidomide did so because of adverse events, but 45% of patients who stopped placebo did so because of progressive disease, Dr. Fink said. Lenalidomide was associated with more neutropenia, gastrointestinal disorders, nervous system disorders, and respiratory and skin disorders than was placebo, but the events were usually mild to moderate in severity, she added.

The three deaths in this study yielded no treatment-based difference in rates of overall survival. Causes of death included acute lymphoblastic leukemia (lenalidomide arm), progressive multifocal leukoencephalopathy (placebo), and Richter’s syndrome (placebo). Venous thromboembolic events were uncommon because patients were given low-dose aspirin or anticoagulant therapy, Dr. Fink noted.

“Lenalidomide is a feasible and efficacious maintenance option for high-risk CLL after chemoimmunotherapy,” she concluded. The low duration of progression-free survival in the placebo group confirms the prognostic utility of assessing risk based on MRD, which might be useful in future studies, she added.

The German CLL Study Group sponsored the trial. Dr. Fink disclosed ties to Mundipharma, Roche, Celgene, and AbbVie.

SAN DIEGO – Patients with chronic lymphocytic leukemia at risk for early relapse were about 85% less likely to progress on lenalidomide maintenance therapy compared with placebo, based on an interim analysis of the randomized phase III CLLM1 study.

After a typical follow-up time of 17.5 months, median durations of progression-free survival were not reached with lenalidomide and were 13 months with placebo, for a hazard ratio of 0.15 (95% confidence interval, 0.06-0.35). These results were “statistically significant, robust, and reliable in favor of lenalidomide,” Anna Fink, MD, said at the 2016 meeting of the American Society of Hematology. Several patients in the lenalidomide arm also converted to minimal residual disease (MRD) negativity, added Dr. Fink of University Hospital Cologne (Germany).

The study included patients whose CLL responded at least partially to front-line chemoimmunotherapy, but who were at high risk of progression – minimal residual disease levels were at least 10^–2, or were between 10^–4 and 10^–2 in patients who also had an unmutated IGHV gene status or del(17p) or TP53 mutations at baseline. Among 89 patients who met these criteria, 60 received lenalidomide maintenance and 20 received placebo.

The initial lenalidomide cycle consisted of 5 mg daily for 28 days. To achieve MRD negativity, clinicians increased this dose during subsequent cycles to a maximum of 15 mg daily for patients who were MRD negative after cycle 12, 20 mg for patients who were MRD negative after cycle 18, and 25 mg for patients who remained MRD positive. Median age was 64 years, more than 80% of patients were male, and the median cumulative illness rating was relatively low at 2, ranging between 0 and 8.

A total of 37% of patients had a high MRD level and 63% had an intermediate level. For both cohorts, lenalidomide maintenance significantly prolonged progression-free survival, compared with placebo, with hazard ratios of 0.17 and 0.13, respectively. Patients received a median of 11 and up to 40 cycles of lenalidomide, but a median of only 8 cycles of placebo.

In all, 43% of lenalidomide patients and 72% of placebo patients stopped maintenance. Nearly a third of those who discontinued lenalidomide did so because of adverse events, but 45% of patients who stopped placebo did so because of progressive disease, Dr. Fink said. Lenalidomide was associated with more neutropenia, gastrointestinal disorders, nervous system disorders, and respiratory and skin disorders than was placebo, but the events were usually mild to moderate in severity, she added.

The three deaths in this study yielded no treatment-based difference in rates of overall survival. Causes of death included acute lymphoblastic leukemia (lenalidomide arm), progressive multifocal leukoencephalopathy (placebo), and Richter’s syndrome (placebo). Venous thromboembolic events were uncommon because patients were given low-dose aspirin or anticoagulant therapy, Dr. Fink noted.

“Lenalidomide is a feasible and efficacious maintenance option for high-risk CLL after chemoimmunotherapy,” she concluded. The low duration of progression-free survival in the placebo group confirms the prognostic utility of assessing risk based on MRD, which might be useful in future studies, she added.

The German CLL Study Group sponsored the trial. Dr. Fink disclosed ties to Mundipharma, Roche, Celgene, and AbbVie.

SAN DIEGO – Patients with chronic lymphocytic leukemia at risk for early relapse were about 85% less likely to progress on lenalidomide maintenance therapy compared with placebo, based on an interim analysis of the randomized phase III CLLM1 study.

After a typical follow-up time of 17.5 months, median durations of progression-free survival were not reached with lenalidomide and were 13 months with placebo, for a hazard ratio of 0.15 (95% confidence interval, 0.06-0.35). These results were “statistically significant, robust, and reliable in favor of lenalidomide,” Anna Fink, MD, said at the 2016 meeting of the American Society of Hematology. Several patients in the lenalidomide arm also converted to minimal residual disease (MRD) negativity, added Dr. Fink of University Hospital Cologne (Germany).

The study included patients whose CLL responded at least partially to front-line chemoimmunotherapy, but who were at high risk of progression – minimal residual disease levels were at least 10^–2, or were between 10^–4 and 10^–2 in patients who also had an unmutated IGHV gene status or del(17p) or TP53 mutations at baseline. Among 89 patients who met these criteria, 60 received lenalidomide maintenance and 20 received placebo.

The initial lenalidomide cycle consisted of 5 mg daily for 28 days. To achieve MRD negativity, clinicians increased this dose during subsequent cycles to a maximum of 15 mg daily for patients who were MRD negative after cycle 12, 20 mg for patients who were MRD negative after cycle 18, and 25 mg for patients who remained MRD positive. Median age was 64 years, more than 80% of patients were male, and the median cumulative illness rating was relatively low at 2, ranging between 0 and 8.

A total of 37% of patients had a high MRD level and 63% had an intermediate level. For both cohorts, lenalidomide maintenance significantly prolonged progression-free survival, compared with placebo, with hazard ratios of 0.17 and 0.13, respectively. Patients received a median of 11 and up to 40 cycles of lenalidomide, but a median of only 8 cycles of placebo.

In all, 43% of lenalidomide patients and 72% of placebo patients stopped maintenance. Nearly a third of those who discontinued lenalidomide did so because of adverse events, but 45% of patients who stopped placebo did so because of progressive disease, Dr. Fink said. Lenalidomide was associated with more neutropenia, gastrointestinal disorders, nervous system disorders, and respiratory and skin disorders than was placebo, but the events were usually mild to moderate in severity, she added.

The three deaths in this study yielded no treatment-based difference in rates of overall survival. Causes of death included acute lymphoblastic leukemia (lenalidomide arm), progressive multifocal leukoencephalopathy (placebo), and Richter’s syndrome (placebo). Venous thromboembolic events were uncommon because patients were given low-dose aspirin or anticoagulant therapy, Dr. Fink noted.

“Lenalidomide is a feasible and efficacious maintenance option for high-risk CLL after chemoimmunotherapy,” she concluded. The low duration of progression-free survival in the placebo group confirms the prognostic utility of assessing risk based on MRD, which might be useful in future studies, she added.

The German CLL Study Group sponsored the trial. Dr. Fink disclosed ties to Mundipharma, Roche, Celgene, and AbbVie.

Two recent clinical practice guidelines – one for cholesterol management and another for treatment of chronic hepatitis C – did not meet the Institute of Medicine’s standards for limiting commercial conflicts of interest, according to results of a new analysis.

In research published online Jan. 17, Akilah A. Jefferson, MD, and Steven D. Pearson, MD, both of the National Institutes of Health in Bethesda, Md., re-examined conflict of interest disclosures for the 2013 American College of Cardiology and American Heart Association cholesterol management guideline, as well as for the American Association for the Study of Liver Diseases and Infectious Diseases Society of America’s joint 2014 guideline related to novel drug treatments for chronic hepatitis C virus (HCV) infection.

The IOM standards for conflicts of interest in guidelines, introduced in 2011, require that less than half the members of any guideline writing committee have a commercial conflict, which can include consultancies, board memberships, and stock in manufacturers of devices or treatments. Guideline writing committee chairs and cochairs should have no commercial conflicts of interest, according to the IOM.

For the cholesterol guidelines, the investigators found that while the committee members fell below the threshold with only 44% reporting commercial conflicts, one writing chair had multiple conflicts until about 1 year before guideline development began, an analysis of concurrent publications suggested. For the HCV guidelines, meanwhile, 72% of the committee members reported commercial conflicts, along with four out of six committee cochairs. An analysis of concurrent publications revealed incomplete disclosure of conflicts among authors of both guidelines (JAMA Intern Med. 2017 Jan 17. doi: 10.1001/jamainternmed.2016.8439).

“Management of levels of commercial [conflict of interest] among guideline committees remains an important problem 5 years after the IOM standards were published,” the investigators wrote. They recommended “broader and more explicit adoption” of the IOM’s framework for conflict of interest.

The study notes that the HCV guideline met all nine of the additional IOM guideline development and evidence standards, while the cholesterol guideline met five of those standards.

The study was funded by an NIH grant. Dr. Pearson reported receiving research funding from foundations and membership dues paid by insurance and pharmaceutical companies. No other disclosures were reported.

Two recent clinical practice guidelines – one for cholesterol management and another for treatment of chronic hepatitis C – did not meet the Institute of Medicine’s standards for limiting commercial conflicts of interest, according to results of a new analysis.

In research published online Jan. 17, Akilah A. Jefferson, MD, and Steven D. Pearson, MD, both of the National Institutes of Health in Bethesda, Md., re-examined conflict of interest disclosures for the 2013 American College of Cardiology and American Heart Association cholesterol management guideline, as well as for the American Association for the Study of Liver Diseases and Infectious Diseases Society of America’s joint 2014 guideline related to novel drug treatments for chronic hepatitis C virus (HCV) infection.

The IOM standards for conflicts of interest in guidelines, introduced in 2011, require that less than half the members of any guideline writing committee have a commercial conflict, which can include consultancies, board memberships, and stock in manufacturers of devices or treatments. Guideline writing committee chairs and cochairs should have no commercial conflicts of interest, according to the IOM.

For the cholesterol guidelines, the investigators found that while the committee members fell below the threshold with only 44% reporting commercial conflicts, one writing chair had multiple conflicts until about 1 year before guideline development began, an analysis of concurrent publications suggested. For the HCV guidelines, meanwhile, 72% of the committee members reported commercial conflicts, along with four out of six committee cochairs. An analysis of concurrent publications revealed incomplete disclosure of conflicts among authors of both guidelines (JAMA Intern Med. 2017 Jan 17. doi: 10.1001/jamainternmed.2016.8439).

“Management of levels of commercial [conflict of interest] among guideline committees remains an important problem 5 years after the IOM standards were published,” the investigators wrote. They recommended “broader and more explicit adoption” of the IOM’s framework for conflict of interest.

The study notes that the HCV guideline met all nine of the additional IOM guideline development and evidence standards, while the cholesterol guideline met five of those standards.

The study was funded by an NIH grant. Dr. Pearson reported receiving research funding from foundations and membership dues paid by insurance and pharmaceutical companies. No other disclosures were reported.

Two recent clinical practice guidelines – one for cholesterol management and another for treatment of chronic hepatitis C – did not meet the Institute of Medicine’s standards for limiting commercial conflicts of interest, according to results of a new analysis.

In research published online Jan. 17, Akilah A. Jefferson, MD, and Steven D. Pearson, MD, both of the National Institutes of Health in Bethesda, Md., re-examined conflict of interest disclosures for the 2013 American College of Cardiology and American Heart Association cholesterol management guideline, as well as for the American Association for the Study of Liver Diseases and Infectious Diseases Society of America’s joint 2014 guideline related to novel drug treatments for chronic hepatitis C virus (HCV) infection.

The IOM standards for conflicts of interest in guidelines, introduced in 2011, require that less than half the members of any guideline writing committee have a commercial conflict, which can include consultancies, board memberships, and stock in manufacturers of devices or treatments. Guideline writing committee chairs and cochairs should have no commercial conflicts of interest, according to the IOM.

For the cholesterol guidelines, the investigators found that while the committee members fell below the threshold with only 44% reporting commercial conflicts, one writing chair had multiple conflicts until about 1 year before guideline development began, an analysis of concurrent publications suggested. For the HCV guidelines, meanwhile, 72% of the committee members reported commercial conflicts, along with four out of six committee cochairs. An analysis of concurrent publications revealed incomplete disclosure of conflicts among authors of both guidelines (JAMA Intern Med. 2017 Jan 17. doi: 10.1001/jamainternmed.2016.8439).

“Management of levels of commercial [conflict of interest] among guideline committees remains an important problem 5 years after the IOM standards were published,” the investigators wrote. They recommended “broader and more explicit adoption” of the IOM’s framework for conflict of interest.

The study notes that the HCV guideline met all nine of the additional IOM guideline development and evidence standards, while the cholesterol guideline met five of those standards.

The study was funded by an NIH grant. Dr. Pearson reported receiving research funding from foundations and membership dues paid by insurance and pharmaceutical companies. No other disclosures were reported.

Take-Home Points

• Music therapists use patient-preferred live music, increasing neurologic cues that enhance movement—a seminal recovery function in postoperative spine patients.
• Music therapy is an evidence-based, integrative treatment addressing body, mind, and spirit.
• Tension release through music therapy can serve as a critical mechanism for building resilience related to pain management.
• Music therapy and music medicine are distinct forms of clinical practice that focus on mind-body integration in the healing process.
• Music therapists, board-certified and licensed by the state as recognized healthcare professionals, address pain management, which is an increasing subspecialty in postoperative care.

About 70% of people in the United States experience at least 1 episode of back pain in their lifetime,¹ and more than 5 million are temporarily or permanently disabled by spinal disorders.^2-4 Some require surgery, which may rectify injury, but pain during recovery is often inevitable, and the road to recovery is not guaranteed to be smooth.^5-20

Postoperative spine patients are at major risk for pain management challenges.^14,15,18,20 Treatment is primarily pharmacologic and based on the surgical team’s pain management orders. Nursing care consists of monitoring the airway, vital signs, and neurovascular status and having patients rate their pain on a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable). Nurses have the challenge of monitoring and continually assessing to make sure patients are achieving the optimal outcomes, particularly during the immediate postoperative period, when pain and anxiety are prominently increased.

Variability in spine surgery outcomes can be explained at least partly on the basis of prognostic psychological factors, including hypochondriasis, hysteria, depression, and poor pain coping strategies (eg, catastrophizing).²¹ In spine surgery patients, kinesiophobia (fear of moving) is a common component of distress that can impede recuperation.^21-23Psychological interventions that assist with the secondary stressors associated with pain and loss during physical recuperation are recommended, with increased attention given to the importance of treating the whole person: body, mind, and spirit.^24-29 Conventional pain-alleviating medical interventions can be enhanced with integrative therapies that empower patients to marshal their inner resources during recovery.^25-28Music therapy may be particularly suited to this effort, as it is adaptable to the patient’s individual and culturally specific needs.^29-33

Rationale for Live Music

Pain is subjective and personal, and warrants an individualized approach to care. There is a body of music medicine research on the use of recorded music in modulating psychological and physiological factors in pain perception.^30,32,34-54 This research supports the unique relationship of music to well-being, and the understanding that controlling any of these factors affects the duration, intensity, and quality of that experience.^41,43,52

These findings provide incentive for breathing-entrained music therapy interventions, which enhance the relaxation response and release of pain-related tension;^32,55-58 empower patients to unlock physical and emotional tension;^32,57,58 provide a channel for expression and body movement; and enhance blood flow and/or alleviate pain by activating neurologic areas involved in the experience of pain.^59-62Studies have found that physical endurance may be enhanced when movement is rhythmically coordinated with a musical stimulus.^63-66 Music may prolong physical endurance by inhibiting psychological feedback associated with physical exertion related to fatigue, which may translate into accelerated recovery periods. When we listen to a rhythmic sound, our brains tend to automatically synchronize, or entrain, to external rhythmic cues that can stimulate increased motor control and coordination.⁶³ Sound can arouse and raise the excitability of spinal motor neurons mediated by auditory-motor neuronal connections on the brain stem and spinal cord level.^64-66 Rhythmically organized sounds serve as a neurological function in our capacity to organize predictable timing cues that are apparent in music, and may result in an effective treatment intervention in recovery.^63,64

Music Therapy in Recovery From Spine Surgery

In music therapy, music is used within a therapeutic relationship to support or affect change in the patient and the treatment regimen.^32,33,56-58 Research on music therapy with patients who are recovering from spine surgery is scant.^67-69 Kleiber and Adamek⁶⁷ studied perceptions of music therapy in 8 adolescents after spinal fusion surgery. In their study, a music therapist provided patients with a postoperative music therapy session focusing on the use of patient-preferred live music for relaxation and expression. Although their qualitative query was based on a therapeutic approach similar to that used in the present study, only 1 session was offered during the recovery period, and follow-up was conducted by survey invitation and telephone. In addition, the number of participants was small, and there was no quantitative measure of pain or other symptoms.

Another study focused on the effects of listening to music on pain intensity and distress after spine surgery.⁶⁸ Patients in the study’s music group made their selections from prerecorded classical music and domestic and international popular songs from various genres and listened to their chosen recordings 30 minutes a day. Although the study was not a music therapy study per se, it showed a positive impact of listening to music on anxiety and pain perception in 60 adults who were randomly assigned to the music group or to a non-music control group (n = 30 in each). Differences between the music and control groups’ VAS ratings of anxiety (Ps = .018-.001) and pain (P = .001) were statistically significant.

Different from our study, the aforementioned studies did not include tension release–focused live music offered within a therapeutic relationship. Our 1.5-year pilot study, conducted prior to the present study indicated that music therapy led to increased resilience and recovery mechanisms.⁵⁸

Methods

Our mixed-methods study design combined standard medical treatment with integrative music therapy interventions based on pain assessments to better understand the effects of music therapy on the recovery of patients after spine surgery.

The Spine Institute of New York within the Department of Orthopedic Surgery at Mount Sinai Beth Israel provides surgical treatment of common spinal cord conditions. Prioritizing patient satisfaction and positive outcomes,^27,28 the institute integrates music therapy through the Louis Armstrong Center for Music and Medicine to enhance treatment of pain symptoms.

Patients were recruited by the research team as per the daily surgical schedule, or through referral by the medical team or patient care navigator. Sixty patients (35 female, 25 male) ranging in age from 40 to 55 years underwent anterior, posterior, or anterior-posterior spinal fusion and were enrolled in the study after signing a participation consent form. Minorities, women, and patients with Medicaid and Medicare were included. Patients who received a diagnosis of clinical psychosis or depression prior to spine injury were excluded.

The experimental group received music therapy plus standard care (medical and nursing care with scheduled pharmacologic pain intervention), and a wait-listed control group received standard care only. A randomization chart created by a blinded statistician who did not have access to the patient census determined the intervention–nonintervention schedule. Patients in the music therapy group received one 30-minute music therapy session during an 8-hour period within 72 hours after surgery.

For both groups, measurements were completed before and after the study window. Control patients were offered music therapy after completion of the post-intervention surveys in order to minimize the ethical dilemma of denying potentially helpful pain intervention. For this same reason, both groups were given the option of receiving follow-up music therapy sessions for the duration of their hospitalization.

The research team consisted of 2 licensed, board-certified music therapists. In addition, Master’s-level music therapy interns completing clinical hours as part of the trajectory for board certification served on the research team over the 5-year period 2009 to 2014, and 13 blinded research assistants helped with enrolling and collecting data on patients.

Intervention

Each music therapy session included a warm-up phase of verbal or musical discourse. Next was the treatment phase, which was based on patient need as assessed during warm-up. Treatment options included use of patient-preferred live music that supported tension release/relaxation through incentive-based clinical improvisation, singing, and/or rhythmic drumming or through breathwork and visualization. Psychoeducation about mind–body awareness through the use of breath and imagery was introduced and explained by the therapist at this time.

The improvised music intervention was focused on making salient the natural harmonic tension-resolution cycles that occur in music and that were entrained to the patient’s presentation (respiratory rate, verbal report, clinical presentation). When patient-preferred precomposed songs were used, tension resolution was achieved by sustaining cadence and resolution, also entrained to the patient’s respiratory cycles.^32,57,58

After the music therapy intervention, a period of closure or integration was facilitated by the therapist contingent on the patient’s degree of alertness. If awake, the patient was supported in a reflexive process of thoughts, impressions, or issues that may have contributed to the overall experience. If the patient was asleep, the researcher returned within 30 minutes for post-intervention interviewing. Interview information was recorded in a qualitative post-participation survey. To prevent bias, researchers who were not the treating clinicians conducted the surveys.

Outcome Measures

Both primary and secondary outcome measures were collected before and after the intervention. The primary outcome measure was VAS pain ratings, and the secondary outcome measures were scores on the Hospital Anxiety and Depression Scale (HADS), the Tampa Scale for Kinesiophobia (TSK), and the Color Analysis Scale (CAS).

VAS. With the VAS, images are used to rate pain. The scale has points labeled 0 to 10 and corresponding faces representing progression in pain intensity. The scale is quickly rendered and can be interpreted according to the patient’s recovery phase at time of rendering.

HADS. The HADS⁷⁰ provides a specific baseline for anxiety and depression as an indicator of how the patient might fare during hospitalization (admission through recovery and discharge).

TSK. The TSK⁷¹ provides insight into the patient’s perception of fear-related movement, which is an important factor in this study because of the movement required for rehabilitation. We used a shortened version of the TSK to accommodate the sensitive threshold for pain tolerance and pharmacologic side effects commonly experienced by spine patients.

CAS. The CAS was developed at the Louis Armstrong Center for Music and Medicine to assess comorbidities and dynamic aspects of pain. Through a coloring exercise, patients illustrate their pain experience, which gives tangible form to the abstract experience of pain.

Coding

We collected patients’ demographic data, including age, sex, and diagnoses. Clinical indicators of the preoperative baseline included lifestyle, surgical history, and prior experience with music or other mind–body strategies for self-regulation.

As fundamental to qualitative methodology,^72,73 the reported responses to questions were grouped into themes that were peer-tested with members of the research team before and during the coding process.

Statistical Methods

Means and standard deviations were used for continuous variables, and frequencies (percentages) for categorical variables. All outcomes were analyzed on an intent-to-treat basis. Repeated-measures analysis of variance was used to compare changes in outcomes from before to after intervention for the music and control groups. In particular, a statistically significant Group (music vs control) × Time (before vs after intervention) interaction would support the hypothesis that there would be more benefit (less pain) in the music group as a result of the music therapy. For all tests, significance was set at P < .05. SPSS Version 20 (IBM) was used for all statistical analyses. Based on previously found differences in heart rate and mobility,³¹ we assumed an effect size of 0.71 for the difference between music and control (no music), which would require 32 patients per group to achieve a power of 0.8 with an α of 0.05.

Results

Of the 136 patients who were asked to participate in the study, 76 were not enrolled; the other 60 were equally assigned to either the control group or the music therapy group (n = 30 in each) according to randomization indicated by a blinded statistician (Figure 1).

Table 2 lists the pre-intervention and post-intervention comparisons of the main outcomes between groups.

Relationship with music was coded for significance and included reports of music as a resource accessed for stimulation and/or relaxation through listening; direct involvement with instrument playing; and history of music training. 

Perceptions of surgical outcome in patients’ responses were coded across 3 themes: (1) optimistic (belief and hope in returning to original baseline of functionality), (2) indifferent (neither hopeful nor cynical about results of surgery), and (3) pessimistic (belief that nothing will restore the quality of life that existed before the spinal condition).

The CAS helped us better understand the diversity and complexity of the pain experience.

Discussion

Our hospital has the unique capability of providing music therapy to postoperative and other hospitalized patients. In this study, we compared the impact of a structured postoperative music therapy program on spine patients relative to control patients who did not receive music therapy after spine surgery.

We found a significant benefit in VAS pain levels (>1 point) but no statistically significant differences in HADS Anxiety, HADS Depression, or TSK scores. Although a 2-point difference is usually considered clinically significant, the degree of change in the music group is notable for having been achieved by nonpharmacologic means with scant chance of adverse effects. We suspect the lack of significant change in HADS Anxiety, HADS Depression, and TSK scores is attributable to the narrow study window. Given the observational data from our pilot study⁵⁸ and ongoing results with spine patients,³² it seems clear that both mood state and resilience in coping are enhanced through an ongoing relationship with music therapy.

The study of a population as vulnerable as patients recovering from spine surgery raises many issues for providers and researchers. Although it is worthwhile to determine the efficacy of integrative modalities in serving these patients, the request for participation in a protocol at such a vulnerable time was often resisted. During our pilot work, it became clear that the ability of potential subjects to comprehend and complete protocol surveys was impacted by adverse effects, including sedation drowsiness; respiratory depression; nausea and vomiting; pruritus; and urinary retention caused by the medications used for postoperative pain management. Consequently, after piloting 5 cases before the main study, we extended the enrollment window to 72 hours.

Other unforeseen intrinsic or external obstacles were identified: Patient-related issues—including availability, level of interest in participation, and inability to participate because of the medication adverse effects mentioned.

Staff investment/education—addressed over the first 3 study years with several in-services, starting with the surgical team and continuing with nursing and support staff in various combinations. These meetings led to the creation of an Institutional Review Board (IRB) approved educational sheet for inclusion in the information packet given to surgical patients on registration.

Programming interruptions—caused by the convergence of several unanticipated factors, including a delay in expedited review of the IRB renewal during the year of Hurricane Sandy and an interruption in the spine team’s service for administrative and program modification.

Conclusion

Music therapy interventions (eg, use of patient-preferred live music) offered within a therapeutic relationship favorably affected pain perceptions in patients recovering from spine surgery. This effect was achieved through several therapeutic entry points, including support of expression and opportunities for emotional catharsis.

At the core of music therapy’s efficacy is individualized treatment, through which patients are supported in their recovery of “self.” Measurable benefits—including increased comfort; reduced pain; improved gait; increased range of motion, endurance, and ability to relax; and empowerment to actively participate in one’s own care through daily activities imbued with an enhanced sense of agency—are of cardinal importance, as they may lead to quicker recovery perceptions and enhanced quality of life.

Am J Orthop. 2017;46(1):E13-E22. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• Music therapists use patient-preferred live music, increasing neurologic cues that enhance movement—a seminal recovery function in postoperative spine patients.
• Music therapy is an evidence-based, integrative treatment addressing body, mind, and spirit.
• Tension release through music therapy can serve as a critical mechanism for building resilience related to pain management.
• Music therapy and music medicine are distinct forms of clinical practice that focus on mind-body integration in the healing process.
• Music therapists, board-certified and licensed by the state as recognized healthcare professionals, address pain management, which is an increasing subspecialty in postoperative care.

About 70% of people in the United States experience at least 1 episode of back pain in their lifetime,¹ and more than 5 million are temporarily or permanently disabled by spinal disorders.^2-4 Some require surgery, which may rectify injury, but pain during recovery is often inevitable, and the road to recovery is not guaranteed to be smooth.^5-20

Postoperative spine patients are at major risk for pain management challenges.^14,15,18,20 Treatment is primarily pharmacologic and based on the surgical team’s pain management orders. Nursing care consists of monitoring the airway, vital signs, and neurovascular status and having patients rate their pain on a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable). Nurses have the challenge of monitoring and continually assessing to make sure patients are achieving the optimal outcomes, particularly during the immediate postoperative period, when pain and anxiety are prominently increased.

Variability in spine surgery outcomes can be explained at least partly on the basis of prognostic psychological factors, including hypochondriasis, hysteria, depression, and poor pain coping strategies (eg, catastrophizing).²¹ In spine surgery patients, kinesiophobia (fear of moving) is a common component of distress that can impede recuperation.^21-23Psychological interventions that assist with the secondary stressors associated with pain and loss during physical recuperation are recommended, with increased attention given to the importance of treating the whole person: body, mind, and spirit.^24-29 Conventional pain-alleviating medical interventions can be enhanced with integrative therapies that empower patients to marshal their inner resources during recovery.^25-28Music therapy may be particularly suited to this effort, as it is adaptable to the patient’s individual and culturally specific needs.^29-33

Rationale for Live Music

Pain is subjective and personal, and warrants an individualized approach to care. There is a body of music medicine research on the use of recorded music in modulating psychological and physiological factors in pain perception.^30,32,34-54 This research supports the unique relationship of music to well-being, and the understanding that controlling any of these factors affects the duration, intensity, and quality of that experience.^41,43,52

These findings provide incentive for breathing-entrained music therapy interventions, which enhance the relaxation response and release of pain-related tension;^32,55-58 empower patients to unlock physical and emotional tension;^32,57,58 provide a channel for expression and body movement; and enhance blood flow and/or alleviate pain by activating neurologic areas involved in the experience of pain.^59-62Studies have found that physical endurance may be enhanced when movement is rhythmically coordinated with a musical stimulus.^63-66 Music may prolong physical endurance by inhibiting psychological feedback associated with physical exertion related to fatigue, which may translate into accelerated recovery periods. When we listen to a rhythmic sound, our brains tend to automatically synchronize, or entrain, to external rhythmic cues that can stimulate increased motor control and coordination.⁶³ Sound can arouse and raise the excitability of spinal motor neurons mediated by auditory-motor neuronal connections on the brain stem and spinal cord level.^64-66 Rhythmically organized sounds serve as a neurological function in our capacity to organize predictable timing cues that are apparent in music, and may result in an effective treatment intervention in recovery.^63,64

Music Therapy in Recovery From Spine Surgery

In music therapy, music is used within a therapeutic relationship to support or affect change in the patient and the treatment regimen.^32,33,56-58 Research on music therapy with patients who are recovering from spine surgery is scant.^67-69 Kleiber and Adamek⁶⁷ studied perceptions of music therapy in 8 adolescents after spinal fusion surgery. In their study, a music therapist provided patients with a postoperative music therapy session focusing on the use of patient-preferred live music for relaxation and expression. Although their qualitative query was based on a therapeutic approach similar to that used in the present study, only 1 session was offered during the recovery period, and follow-up was conducted by survey invitation and telephone. In addition, the number of participants was small, and there was no quantitative measure of pain or other symptoms.

Another study focused on the effects of listening to music on pain intensity and distress after spine surgery.⁶⁸ Patients in the study’s music group made their selections from prerecorded classical music and domestic and international popular songs from various genres and listened to their chosen recordings 30 minutes a day. Although the study was not a music therapy study per se, it showed a positive impact of listening to music on anxiety and pain perception in 60 adults who were randomly assigned to the music group or to a non-music control group (n = 30 in each). Differences between the music and control groups’ VAS ratings of anxiety (Ps = .018-.001) and pain (P = .001) were statistically significant.

Different from our study, the aforementioned studies did not include tension release–focused live music offered within a therapeutic relationship. Our 1.5-year pilot study, conducted prior to the present study indicated that music therapy led to increased resilience and recovery mechanisms.⁵⁸

Methods

Our mixed-methods study design combined standard medical treatment with integrative music therapy interventions based on pain assessments to better understand the effects of music therapy on the recovery of patients after spine surgery.

The Spine Institute of New York within the Department of Orthopedic Surgery at Mount Sinai Beth Israel provides surgical treatment of common spinal cord conditions. Prioritizing patient satisfaction and positive outcomes,^27,28 the institute integrates music therapy through the Louis Armstrong Center for Music and Medicine to enhance treatment of pain symptoms.

Patients were recruited by the research team as per the daily surgical schedule, or through referral by the medical team or patient care navigator. Sixty patients (35 female, 25 male) ranging in age from 40 to 55 years underwent anterior, posterior, or anterior-posterior spinal fusion and were enrolled in the study after signing a participation consent form. Minorities, women, and patients with Medicaid and Medicare were included. Patients who received a diagnosis of clinical psychosis or depression prior to spine injury were excluded.

The experimental group received music therapy plus standard care (medical and nursing care with scheduled pharmacologic pain intervention), and a wait-listed control group received standard care only. A randomization chart created by a blinded statistician who did not have access to the patient census determined the intervention–nonintervention schedule. Patients in the music therapy group received one 30-minute music therapy session during an 8-hour period within 72 hours after surgery.

For both groups, measurements were completed before and after the study window. Control patients were offered music therapy after completion of the post-intervention surveys in order to minimize the ethical dilemma of denying potentially helpful pain intervention. For this same reason, both groups were given the option of receiving follow-up music therapy sessions for the duration of their hospitalization.

The research team consisted of 2 licensed, board-certified music therapists. In addition, Master’s-level music therapy interns completing clinical hours as part of the trajectory for board certification served on the research team over the 5-year period 2009 to 2014, and 13 blinded research assistants helped with enrolling and collecting data on patients.

Intervention

Each music therapy session included a warm-up phase of verbal or musical discourse. Next was the treatment phase, which was based on patient need as assessed during warm-up. Treatment options included use of patient-preferred live music that supported tension release/relaxation through incentive-based clinical improvisation, singing, and/or rhythmic drumming or through breathwork and visualization. Psychoeducation about mind–body awareness through the use of breath and imagery was introduced and explained by the therapist at this time.

The improvised music intervention was focused on making salient the natural harmonic tension-resolution cycles that occur in music and that were entrained to the patient’s presentation (respiratory rate, verbal report, clinical presentation). When patient-preferred precomposed songs were used, tension resolution was achieved by sustaining cadence and resolution, also entrained to the patient’s respiratory cycles.^32,57,58

After the music therapy intervention, a period of closure or integration was facilitated by the therapist contingent on the patient’s degree of alertness. If awake, the patient was supported in a reflexive process of thoughts, impressions, or issues that may have contributed to the overall experience. If the patient was asleep, the researcher returned within 30 minutes for post-intervention interviewing. Interview information was recorded in a qualitative post-participation survey. To prevent bias, researchers who were not the treating clinicians conducted the surveys.

Outcome Measures

Both primary and secondary outcome measures were collected before and after the intervention. The primary outcome measure was VAS pain ratings, and the secondary outcome measures were scores on the Hospital Anxiety and Depression Scale (HADS), the Tampa Scale for Kinesiophobia (TSK), and the Color Analysis Scale (CAS).

VAS. With the VAS, images are used to rate pain. The scale has points labeled 0 to 10 and corresponding faces representing progression in pain intensity. The scale is quickly rendered and can be interpreted according to the patient’s recovery phase at time of rendering.

HADS. The HADS⁷⁰ provides a specific baseline for anxiety and depression as an indicator of how the patient might fare during hospitalization (admission through recovery and discharge).

TSK. The TSK⁷¹ provides insight into the patient’s perception of fear-related movement, which is an important factor in this study because of the movement required for rehabilitation. We used a shortened version of the TSK to accommodate the sensitive threshold for pain tolerance and pharmacologic side effects commonly experienced by spine patients.

CAS. The CAS was developed at the Louis Armstrong Center for Music and Medicine to assess comorbidities and dynamic aspects of pain. Through a coloring exercise, patients illustrate their pain experience, which gives tangible form to the abstract experience of pain.

Coding

We collected patients’ demographic data, including age, sex, and diagnoses. Clinical indicators of the preoperative baseline included lifestyle, surgical history, and prior experience with music or other mind–body strategies for self-regulation.

As fundamental to qualitative methodology,^72,73 the reported responses to questions were grouped into themes that were peer-tested with members of the research team before and during the coding process.

Statistical Methods

Means and standard deviations were used for continuous variables, and frequencies (percentages) for categorical variables. All outcomes were analyzed on an intent-to-treat basis. Repeated-measures analysis of variance was used to compare changes in outcomes from before to after intervention for the music and control groups. In particular, a statistically significant Group (music vs control) × Time (before vs after intervention) interaction would support the hypothesis that there would be more benefit (less pain) in the music group as a result of the music therapy. For all tests, significance was set at P < .05. SPSS Version 20 (IBM) was used for all statistical analyses. Based on previously found differences in heart rate and mobility,³¹ we assumed an effect size of 0.71 for the difference between music and control (no music), which would require 32 patients per group to achieve a power of 0.8 with an α of 0.05.

Results

Of the 136 patients who were asked to participate in the study, 76 were not enrolled; the other 60 were equally assigned to either the control group or the music therapy group (n = 30 in each) according to randomization indicated by a blinded statistician (Figure 1).

Table 2 lists the pre-intervention and post-intervention comparisons of the main outcomes between groups.

Relationship with music was coded for significance and included reports of music as a resource accessed for stimulation and/or relaxation through listening; direct involvement with instrument playing; and history of music training. 

Perceptions of surgical outcome in patients’ responses were coded across 3 themes: (1) optimistic (belief and hope in returning to original baseline of functionality), (2) indifferent (neither hopeful nor cynical about results of surgery), and (3) pessimistic (belief that nothing will restore the quality of life that existed before the spinal condition).

The CAS helped us better understand the diversity and complexity of the pain experience.

Discussion

Our hospital has the unique capability of providing music therapy to postoperative and other hospitalized patients. In this study, we compared the impact of a structured postoperative music therapy program on spine patients relative to control patients who did not receive music therapy after spine surgery.

We found a significant benefit in VAS pain levels (>1 point) but no statistically significant differences in HADS Anxiety, HADS Depression, or TSK scores. Although a 2-point difference is usually considered clinically significant, the degree of change in the music group is notable for having been achieved by nonpharmacologic means with scant chance of adverse effects. We suspect the lack of significant change in HADS Anxiety, HADS Depression, and TSK scores is attributable to the narrow study window. Given the observational data from our pilot study⁵⁸ and ongoing results with spine patients,³² it seems clear that both mood state and resilience in coping are enhanced through an ongoing relationship with music therapy.

The study of a population as vulnerable as patients recovering from spine surgery raises many issues for providers and researchers. Although it is worthwhile to determine the efficacy of integrative modalities in serving these patients, the request for participation in a protocol at such a vulnerable time was often resisted. During our pilot work, it became clear that the ability of potential subjects to comprehend and complete protocol surveys was impacted by adverse effects, including sedation drowsiness; respiratory depression; nausea and vomiting; pruritus; and urinary retention caused by the medications used for postoperative pain management. Consequently, after piloting 5 cases before the main study, we extended the enrollment window to 72 hours.

Other unforeseen intrinsic or external obstacles were identified: Patient-related issues—including availability, level of interest in participation, and inability to participate because of the medication adverse effects mentioned.

Staff investment/education—addressed over the first 3 study years with several in-services, starting with the surgical team and continuing with nursing and support staff in various combinations. These meetings led to the creation of an Institutional Review Board (IRB) approved educational sheet for inclusion in the information packet given to surgical patients on registration.

Programming interruptions—caused by the convergence of several unanticipated factors, including a delay in expedited review of the IRB renewal during the year of Hurricane Sandy and an interruption in the spine team’s service for administrative and program modification.

Conclusion

Music therapy interventions (eg, use of patient-preferred live music) offered within a therapeutic relationship favorably affected pain perceptions in patients recovering from spine surgery. This effect was achieved through several therapeutic entry points, including support of expression and opportunities for emotional catharsis.

At the core of music therapy’s efficacy is individualized treatment, through which patients are supported in their recovery of “self.” Measurable benefits—including increased comfort; reduced pain; improved gait; increased range of motion, endurance, and ability to relax; and empowerment to actively participate in one’s own care through daily activities imbued with an enhanced sense of agency—are of cardinal importance, as they may lead to quicker recovery perceptions and enhanced quality of life.

Am J Orthop. 2017;46(1):E13-E22. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• Music therapists use patient-preferred live music, increasing neurologic cues that enhance movement—a seminal recovery function in postoperative spine patients.
• Music therapy is an evidence-based, integrative treatment addressing body, mind, and spirit.
• Tension release through music therapy can serve as a critical mechanism for building resilience related to pain management.
• Music therapy and music medicine are distinct forms of clinical practice that focus on mind-body integration in the healing process.
• Music therapists, board-certified and licensed by the state as recognized healthcare professionals, address pain management, which is an increasing subspecialty in postoperative care.

About 70% of people in the United States experience at least 1 episode of back pain in their lifetime,¹ and more than 5 million are temporarily or permanently disabled by spinal disorders.^2-4 Some require surgery, which may rectify injury, but pain during recovery is often inevitable, and the road to recovery is not guaranteed to be smooth.^5-20

Postoperative spine patients are at major risk for pain management challenges.^14,15,18,20 Treatment is primarily pharmacologic and based on the surgical team’s pain management orders. Nursing care consists of monitoring the airway, vital signs, and neurovascular status and having patients rate their pain on a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable). Nurses have the challenge of monitoring and continually assessing to make sure patients are achieving the optimal outcomes, particularly during the immediate postoperative period, when pain and anxiety are prominently increased.

Variability in spine surgery outcomes can be explained at least partly on the basis of prognostic psychological factors, including hypochondriasis, hysteria, depression, and poor pain coping strategies (eg, catastrophizing).²¹ In spine surgery patients, kinesiophobia (fear of moving) is a common component of distress that can impede recuperation.^21-23Psychological interventions that assist with the secondary stressors associated with pain and loss during physical recuperation are recommended, with increased attention given to the importance of treating the whole person: body, mind, and spirit.^24-29 Conventional pain-alleviating medical interventions can be enhanced with integrative therapies that empower patients to marshal their inner resources during recovery.^25-28Music therapy may be particularly suited to this effort, as it is adaptable to the patient’s individual and culturally specific needs.^29-33

Rationale for Live Music

Pain is subjective and personal, and warrants an individualized approach to care. There is a body of music medicine research on the use of recorded music in modulating psychological and physiological factors in pain perception.^30,32,34-54 This research supports the unique relationship of music to well-being, and the understanding that controlling any of these factors affects the duration, intensity, and quality of that experience.^41,43,52

These findings provide incentive for breathing-entrained music therapy interventions, which enhance the relaxation response and release of pain-related tension;^32,55-58 empower patients to unlock physical and emotional tension;^32,57,58 provide a channel for expression and body movement; and enhance blood flow and/or alleviate pain by activating neurologic areas involved in the experience of pain.^59-62Studies have found that physical endurance may be enhanced when movement is rhythmically coordinated with a musical stimulus.^63-66 Music may prolong physical endurance by inhibiting psychological feedback associated with physical exertion related to fatigue, which may translate into accelerated recovery periods. When we listen to a rhythmic sound, our brains tend to automatically synchronize, or entrain, to external rhythmic cues that can stimulate increased motor control and coordination.⁶³ Sound can arouse and raise the excitability of spinal motor neurons mediated by auditory-motor neuronal connections on the brain stem and spinal cord level.^64-66 Rhythmically organized sounds serve as a neurological function in our capacity to organize predictable timing cues that are apparent in music, and may result in an effective treatment intervention in recovery.^63,64

Music Therapy in Recovery From Spine Surgery

In music therapy, music is used within a therapeutic relationship to support or affect change in the patient and the treatment regimen.^32,33,56-58 Research on music therapy with patients who are recovering from spine surgery is scant.^67-69 Kleiber and Adamek⁶⁷ studied perceptions of music therapy in 8 adolescents after spinal fusion surgery. In their study, a music therapist provided patients with a postoperative music therapy session focusing on the use of patient-preferred live music for relaxation and expression. Although their qualitative query was based on a therapeutic approach similar to that used in the present study, only 1 session was offered during the recovery period, and follow-up was conducted by survey invitation and telephone. In addition, the number of participants was small, and there was no quantitative measure of pain or other symptoms.

Another study focused on the effects of listening to music on pain intensity and distress after spine surgery.⁶⁸ Patients in the study’s music group made their selections from prerecorded classical music and domestic and international popular songs from various genres and listened to their chosen recordings 30 minutes a day. Although the study was not a music therapy study per se, it showed a positive impact of listening to music on anxiety and pain perception in 60 adults who were randomly assigned to the music group or to a non-music control group (n = 30 in each). Differences between the music and control groups’ VAS ratings of anxiety (Ps = .018-.001) and pain (P = .001) were statistically significant.

Different from our study, the aforementioned studies did not include tension release–focused live music offered within a therapeutic relationship. Our 1.5-year pilot study, conducted prior to the present study indicated that music therapy led to increased resilience and recovery mechanisms.⁵⁸

Methods

Our mixed-methods study design combined standard medical treatment with integrative music therapy interventions based on pain assessments to better understand the effects of music therapy on the recovery of patients after spine surgery.

The Spine Institute of New York within the Department of Orthopedic Surgery at Mount Sinai Beth Israel provides surgical treatment of common spinal cord conditions. Prioritizing patient satisfaction and positive outcomes,^27,28 the institute integrates music therapy through the Louis Armstrong Center for Music and Medicine to enhance treatment of pain symptoms.

Patients were recruited by the research team as per the daily surgical schedule, or through referral by the medical team or patient care navigator. Sixty patients (35 female, 25 male) ranging in age from 40 to 55 years underwent anterior, posterior, or anterior-posterior spinal fusion and were enrolled in the study after signing a participation consent form. Minorities, women, and patients with Medicaid and Medicare were included. Patients who received a diagnosis of clinical psychosis or depression prior to spine injury were excluded.

The experimental group received music therapy plus standard care (medical and nursing care with scheduled pharmacologic pain intervention), and a wait-listed control group received standard care only. A randomization chart created by a blinded statistician who did not have access to the patient census determined the intervention–nonintervention schedule. Patients in the music therapy group received one 30-minute music therapy session during an 8-hour period within 72 hours after surgery.

For both groups, measurements were completed before and after the study window. Control patients were offered music therapy after completion of the post-intervention surveys in order to minimize the ethical dilemma of denying potentially helpful pain intervention. For this same reason, both groups were given the option of receiving follow-up music therapy sessions for the duration of their hospitalization.

The research team consisted of 2 licensed, board-certified music therapists. In addition, Master’s-level music therapy interns completing clinical hours as part of the trajectory for board certification served on the research team over the 5-year period 2009 to 2014, and 13 blinded research assistants helped with enrolling and collecting data on patients.

Intervention

Each music therapy session included a warm-up phase of verbal or musical discourse. Next was the treatment phase, which was based on patient need as assessed during warm-up. Treatment options included use of patient-preferred live music that supported tension release/relaxation through incentive-based clinical improvisation, singing, and/or rhythmic drumming or through breathwork and visualization. Psychoeducation about mind–body awareness through the use of breath and imagery was introduced and explained by the therapist at this time.

The improvised music intervention was focused on making salient the natural harmonic tension-resolution cycles that occur in music and that were entrained to the patient’s presentation (respiratory rate, verbal report, clinical presentation). When patient-preferred precomposed songs were used, tension resolution was achieved by sustaining cadence and resolution, also entrained to the patient’s respiratory cycles.^32,57,58

After the music therapy intervention, a period of closure or integration was facilitated by the therapist contingent on the patient’s degree of alertness. If awake, the patient was supported in a reflexive process of thoughts, impressions, or issues that may have contributed to the overall experience. If the patient was asleep, the researcher returned within 30 minutes for post-intervention interviewing. Interview information was recorded in a qualitative post-participation survey. To prevent bias, researchers who were not the treating clinicians conducted the surveys.

Outcome Measures

Both primary and secondary outcome measures were collected before and after the intervention. The primary outcome measure was VAS pain ratings, and the secondary outcome measures were scores on the Hospital Anxiety and Depression Scale (HADS), the Tampa Scale for Kinesiophobia (TSK), and the Color Analysis Scale (CAS).

VAS. With the VAS, images are used to rate pain. The scale has points labeled 0 to 10 and corresponding faces representing progression in pain intensity. The scale is quickly rendered and can be interpreted according to the patient’s recovery phase at time of rendering.

HADS. The HADS⁷⁰ provides a specific baseline for anxiety and depression as an indicator of how the patient might fare during hospitalization (admission through recovery and discharge).

TSK. The TSK⁷¹ provides insight into the patient’s perception of fear-related movement, which is an important factor in this study because of the movement required for rehabilitation. We used a shortened version of the TSK to accommodate the sensitive threshold for pain tolerance and pharmacologic side effects commonly experienced by spine patients.

CAS. The CAS was developed at the Louis Armstrong Center for Music and Medicine to assess comorbidities and dynamic aspects of pain. Through a coloring exercise, patients illustrate their pain experience, which gives tangible form to the abstract experience of pain.

Coding

We collected patients’ demographic data, including age, sex, and diagnoses. Clinical indicators of the preoperative baseline included lifestyle, surgical history, and prior experience with music or other mind–body strategies for self-regulation.

As fundamental to qualitative methodology,^72,73 the reported responses to questions were grouped into themes that were peer-tested with members of the research team before and during the coding process.

Statistical Methods

Means and standard deviations were used for continuous variables, and frequencies (percentages) for categorical variables. All outcomes were analyzed on an intent-to-treat basis. Repeated-measures analysis of variance was used to compare changes in outcomes from before to after intervention for the music and control groups. In particular, a statistically significant Group (music vs control) × Time (before vs after intervention) interaction would support the hypothesis that there would be more benefit (less pain) in the music group as a result of the music therapy. For all tests, significance was set at P < .05. SPSS Version 20 (IBM) was used for all statistical analyses. Based on previously found differences in heart rate and mobility,³¹ we assumed an effect size of 0.71 for the difference between music and control (no music), which would require 32 patients per group to achieve a power of 0.8 with an α of 0.05.

Results

Of the 136 patients who were asked to participate in the study, 76 were not enrolled; the other 60 were equally assigned to either the control group or the music therapy group (n = 30 in each) according to randomization indicated by a blinded statistician (Figure 1).

Table 2 lists the pre-intervention and post-intervention comparisons of the main outcomes between groups.

Relationship with music was coded for significance and included reports of music as a resource accessed for stimulation and/or relaxation through listening; direct involvement with instrument playing; and history of music training. 

Perceptions of surgical outcome in patients’ responses were coded across 3 themes: (1) optimistic (belief and hope in returning to original baseline of functionality), (2) indifferent (neither hopeful nor cynical about results of surgery), and (3) pessimistic (belief that nothing will restore the quality of life that existed before the spinal condition).

The CAS helped us better understand the diversity and complexity of the pain experience.

Discussion

Our hospital has the unique capability of providing music therapy to postoperative and other hospitalized patients. In this study, we compared the impact of a structured postoperative music therapy program on spine patients relative to control patients who did not receive music therapy after spine surgery.

We found a significant benefit in VAS pain levels (>1 point) but no statistically significant differences in HADS Anxiety, HADS Depression, or TSK scores. Although a 2-point difference is usually considered clinically significant, the degree of change in the music group is notable for having been achieved by nonpharmacologic means with scant chance of adverse effects. We suspect the lack of significant change in HADS Anxiety, HADS Depression, and TSK scores is attributable to the narrow study window. Given the observational data from our pilot study⁵⁸ and ongoing results with spine patients,³² it seems clear that both mood state and resilience in coping are enhanced through an ongoing relationship with music therapy.

The study of a population as vulnerable as patients recovering from spine surgery raises many issues for providers and researchers. Although it is worthwhile to determine the efficacy of integrative modalities in serving these patients, the request for participation in a protocol at such a vulnerable time was often resisted. During our pilot work, it became clear that the ability of potential subjects to comprehend and complete protocol surveys was impacted by adverse effects, including sedation drowsiness; respiratory depression; nausea and vomiting; pruritus; and urinary retention caused by the medications used for postoperative pain management. Consequently, after piloting 5 cases before the main study, we extended the enrollment window to 72 hours.

Other unforeseen intrinsic or external obstacles were identified: Patient-related issues—including availability, level of interest in participation, and inability to participate because of the medication adverse effects mentioned.

Staff investment/education—addressed over the first 3 study years with several in-services, starting with the surgical team and continuing with nursing and support staff in various combinations. These meetings led to the creation of an Institutional Review Board (IRB) approved educational sheet for inclusion in the information packet given to surgical patients on registration.

Programming interruptions—caused by the convergence of several unanticipated factors, including a delay in expedited review of the IRB renewal during the year of Hurricane Sandy and an interruption in the spine team’s service for administrative and program modification.

Conclusion

Music therapy interventions (eg, use of patient-preferred live music) offered within a therapeutic relationship favorably affected pain perceptions in patients recovering from spine surgery. This effect was achieved through several therapeutic entry points, including support of expression and opportunities for emotional catharsis.

At the core of music therapy’s efficacy is individualized treatment, through which patients are supported in their recovery of “self.” Measurable benefits—including increased comfort; reduced pain; improved gait; increased range of motion, endurance, and ability to relax; and empowerment to actively participate in one’s own care through daily activities imbued with an enhanced sense of agency—are of cardinal importance, as they may lead to quicker recovery perceptions and enhanced quality of life.

Am J Orthop. 2017;46(1):E13-E22. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Pneumococcal conjugate vaccines (PCV) in immunized children show effectiveness against head and neck infections (HNIs), especially against pneumococcal HNIs (pHNIs) that require hospitalization, according to Tal Marom, MD, of Tel Aviv University, Zerifin, Israel, and associates.

In a retrospective study, researchers identified children aged 0-16 years who were hospitalized with HNIs between Jan. 1, 2007 and Dec. 31, 2014. HNIs accounted for 2.5%-4.7% of admissions to the pediatric department, and there was a downward trend in the incidence in the post-PCV years, compared with previous years. Of the 820 children admitted with HNIs, 11% children were identified with pHNIs, 5% with acute otitis media, 4% with acute mastoiditis, and 2% with meningitis; there were no cases of pneumococcal acute bacterial sinusitis or pneumococcal head and neck abscesses. In 2009-2010 (considered as the “transition years,” in which both PCV7 and PCV13 were implemented in Israel), pHNIs incidence sharply decreased, from 7/1,000 to 1.74/1,000 hospitalized children per year, because of a 55% reduction of pneumococcal acute otitis media episodes. There also was an additional decrease observed in the post-PCV years of 2012-2014 (1.62/1,000 hospitalized children per year).

It was noted that unimmunized children were more likely to suffer from pneumococcal infections than immunized children (P = .001). There were no significant differences in the clinical presentation of these two groups, except for the need for surgery, which was significantly greater in immunized children (P = .042).

“The findings of the current study provide further evidence of PCV effectiveness against HNIs in PCV immunized children, and particularly against pHNI which required hospitalization,” Dr. Marom and associates concluded. “A substantial reduction in the all-cause HNIs incidence, and more specifically in pHNIs, in PCV immunized children who required hospitalization, was evident in the present study. This was also followed by a significant reduction in [acute otitis media] rates and to a much lesser extent, in [acute mastoiditis] and meningitis rates.”

Find the full study in the Pediatric Infectious Disease Journal (2016. doi: 10.1097/INF.0000000000001425).

[email protected]

Pneumococcal conjugate vaccines (PCV) in immunized children show effectiveness against head and neck infections (HNIs), especially against pneumococcal HNIs (pHNIs) that require hospitalization, according to Tal Marom, MD, of Tel Aviv University, Zerifin, Israel, and associates.

In a retrospective study, researchers identified children aged 0-16 years who were hospitalized with HNIs between Jan. 1, 2007 and Dec. 31, 2014. HNIs accounted for 2.5%-4.7% of admissions to the pediatric department, and there was a downward trend in the incidence in the post-PCV years, compared with previous years. Of the 820 children admitted with HNIs, 11% children were identified with pHNIs, 5% with acute otitis media, 4% with acute mastoiditis, and 2% with meningitis; there were no cases of pneumococcal acute bacterial sinusitis or pneumococcal head and neck abscesses. In 2009-2010 (considered as the “transition years,” in which both PCV7 and PCV13 were implemented in Israel), pHNIs incidence sharply decreased, from 7/1,000 to 1.74/1,000 hospitalized children per year, because of a 55% reduction of pneumococcal acute otitis media episodes. There also was an additional decrease observed in the post-PCV years of 2012-2014 (1.62/1,000 hospitalized children per year).

It was noted that unimmunized children were more likely to suffer from pneumococcal infections than immunized children (P = .001). There were no significant differences in the clinical presentation of these two groups, except for the need for surgery, which was significantly greater in immunized children (P = .042).

“The findings of the current study provide further evidence of PCV effectiveness against HNIs in PCV immunized children, and particularly against pHNI which required hospitalization,” Dr. Marom and associates concluded. “A substantial reduction in the all-cause HNIs incidence, and more specifically in pHNIs, in PCV immunized children who required hospitalization, was evident in the present study. This was also followed by a significant reduction in [acute otitis media] rates and to a much lesser extent, in [acute mastoiditis] and meningitis rates.”

Find the full study in the Pediatric Infectious Disease Journal (2016. doi: 10.1097/INF.0000000000001425).

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Pneumococcal conjugate vaccines (PCV) in immunized children show effectiveness against head and neck infections (HNIs), especially against pneumococcal HNIs (pHNIs) that require hospitalization, according to Tal Marom, MD, of Tel Aviv University, Zerifin, Israel, and associates.

In a retrospective study, researchers identified children aged 0-16 years who were hospitalized with HNIs between Jan. 1, 2007 and Dec. 31, 2014. HNIs accounted for 2.5%-4.7% of admissions to the pediatric department, and there was a downward trend in the incidence in the post-PCV years, compared with previous years. Of the 820 children admitted with HNIs, 11% children were identified with pHNIs, 5% with acute otitis media, 4% with acute mastoiditis, and 2% with meningitis; there were no cases of pneumococcal acute bacterial sinusitis or pneumococcal head and neck abscesses. In 2009-2010 (considered as the “transition years,” in which both PCV7 and PCV13 were implemented in Israel), pHNIs incidence sharply decreased, from 7/1,000 to 1.74/1,000 hospitalized children per year, because of a 55% reduction of pneumococcal acute otitis media episodes. There also was an additional decrease observed in the post-PCV years of 2012-2014 (1.62/1,000 hospitalized children per year).

It was noted that unimmunized children were more likely to suffer from pneumococcal infections than immunized children (P = .001). There were no significant differences in the clinical presentation of these two groups, except for the need for surgery, which was significantly greater in immunized children (P = .042).

“The findings of the current study provide further evidence of PCV effectiveness against HNIs in PCV immunized children, and particularly against pHNI which required hospitalization,” Dr. Marom and associates concluded. “A substantial reduction in the all-cause HNIs incidence, and more specifically in pHNIs, in PCV immunized children who required hospitalization, was evident in the present study. This was also followed by a significant reduction in [acute otitis media] rates and to a much lesser extent, in [acute mastoiditis] and meningitis rates.”

Find the full study in the Pediatric Infectious Disease Journal (2016. doi: 10.1097/INF.0000000000001425).

[email protected]

Delaying the clamping of the umbilical cord for 3 minutes after delivery decreased anemia for as long as 8-12 months in a population at high risk for the disorder, according to a report published online Jan. 17 in JAMA Pediatrics.

If early (within 1 minute of birth) cord clamping is avoided after delivery, fetoplacental blood moves into the newborn, augmenting his or her blood volume by 30%-40%. This is known to increase iron stores and prevent iron deficiency for at least 6 months, but until now there has been little evidence of how long this beneficial effect persists, said Ashish KC, MD, PhD, of International Maternal and Child Health, Uppsala (Sweden) University and the United Nations Children’s Fund, Lalitpur, Nepal, and associates.

arztsamui/Thinkstock

Delaying the clamping of the umbilical cord for 3 minutes after delivery decreased anemia for as long as 8-12 months in a population at high risk for the disorder, according to a report published online Jan. 17 in JAMA Pediatrics.

If early (within 1 minute of birth) cord clamping is avoided after delivery, fetoplacental blood moves into the newborn, augmenting his or her blood volume by 30%-40%. This is known to increase iron stores and prevent iron deficiency for at least 6 months, but until now there has been little evidence of how long this beneficial effect persists, said Ashish KC, MD, PhD, of International Maternal and Child Health, Uppsala (Sweden) University and the United Nations Children’s Fund, Lalitpur, Nepal, and associates.

arztsamui/Thinkstock

Delaying the clamping of the umbilical cord for 3 minutes after delivery decreased anemia for as long as 8-12 months in a population at high risk for the disorder, according to a report published online Jan. 17 in JAMA Pediatrics.

If early (within 1 minute of birth) cord clamping is avoided after delivery, fetoplacental blood moves into the newborn, augmenting his or her blood volume by 30%-40%. This is known to increase iron stores and prevent iron deficiency for at least 6 months, but until now there has been little evidence of how long this beneficial effect persists, said Ashish KC, MD, PhD, of International Maternal and Child Health, Uppsala (Sweden) University and the United Nations Children’s Fund, Lalitpur, Nepal, and associates.

arztsamui/Thinkstock

Asthma was ruled out in 33% of adults in the general Canadian population who had been diagnosed by a physician during the preceding 5 years, according to a report published online Jan. 17 in JAMA.

In a prospective multicenter cohort study involving 613 asthma patients, 203 had no evidence of current asthma when they underwent serial assessments of respiratory symptoms, lung function, and bronchial provocation testing while not taking asthma medications. More than 90% of these 203 participants safely refrained from using the medications for an additional 1-year follow-up period, said Shawn D. Aaron, MD, of Ottawa (Ont.) Hospital Research Institute, and his associates in the Canadian Respiratory Research Network.

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Asthma was ruled out in 33% of adults in the general Canadian population who had been diagnosed by a physician during the preceding 5 years, according to a report published online Jan. 17 in JAMA.

In a prospective multicenter cohort study involving 613 asthma patients, 203 had no evidence of current asthma when they underwent serial assessments of respiratory symptoms, lung function, and bronchial provocation testing while not taking asthma medications. More than 90% of these 203 participants safely refrained from using the medications for an additional 1-year follow-up period, said Shawn D. Aaron, MD, of Ottawa (Ont.) Hospital Research Institute, and his associates in the Canadian Respiratory Research Network.

copyright marekuliasz/Thinkstock

[email protected]

Asthma was ruled out in 33% of adults in the general Canadian population who had been diagnosed by a physician during the preceding 5 years, according to a report published online Jan. 17 in JAMA.

In a prospective multicenter cohort study involving 613 asthma patients, 203 had no evidence of current asthma when they underwent serial assessments of respiratory symptoms, lung function, and bronchial provocation testing while not taking asthma medications. More than 90% of these 203 participants safely refrained from using the medications for an additional 1-year follow-up period, said Shawn D. Aaron, MD, of Ottawa (Ont.) Hospital Research Institute, and his associates in the Canadian Respiratory Research Network.

copyright marekuliasz/Thinkstock

[email protected]

An assay designed to distinguish between bacterial and viral infections of the lower respiratory tract appears effective and shows promise for helping hospital physicians reduce overprescribing of antibiotics to children, a study showed.

“It is often not possible to differentiate between bacterial and nonbacterial disease on the basis of clinical judgment alone, [so] antibiotics are prescribed almost twice as often as required in children with acute respiratory tract infections in the USA,” wrote Chantal B. van Houten of the University Medical Centre Utrecht (the Netherlands) and associates in a study published in the Lancet Infectious Diseases.

The assay in question is called ImmunoXpert, which uses three biomarkers – tumor necrosis factor–related apoptosis-inducing ligand (TRAIL), interferon-gamma–induced protein-10 (IP-10), and C-reactive protein (CRP) – to determine if a lower respiratory tract infection has a viral or bacterial origin. A total of 777 subjects, aged 2-60 months, were recruited from four hospitals in the Netherlands and two hospitals in Israel between October 16, 2013, and March 1, 2015 (Lancet Inf Dis. 2016 Dec. doi: 10.1016/S1473-3099(16)30519-9).

The patients all had fevers with unidentified sources when they presented, and had a follow-up assessment carried out 28 days after baseline. Blood samples and nasal swabs were collected within 24 hours of presentation for assay analysis. Additionally, every subject was diagnosed as “bacterial” or “viral” by a three-member panel of pediatricians, whose diagnoses were based on the data available from the follow-up assessment and from clinical and laboratory data. The panel diagnosis for each subject was used as the reference standard.

Of the 777 subjects initially recruited, 200 were excluded from the final analysis for various reasons. Of the 577 who remained, the panel diagnosed 435 as having a viral infection and 71 as having a bacterial infection; 71 were deemed “inconclusive.” The panel was unanimous in 354 of these cases, and a majority of the panel (two of the three experts) agreed in 443 of these cases. In unanimous cases, the sensitivity of distinguishing between viral and bacterial cases correctly was 87.8%, with a specificity of 93.0%. The panel’s positive and negative predictive value were 62.1% and 98.3%, respectively.

The assay’s sensitivity rate in distinguishing between viral and bacterial infections was very close: 86.7%, with a specificity of 91.1%, which the authors noted was “promising diagnostic accuracy.” The positive predictive value of the assay was 60.5%, while the negative predictive value was found to be 97.8%.

Regarding the 71 cases that were deemed “inconclusive,” Dr. van Houten and coauthors acknowledged that “such inconclusive cases are inherent to studies without a gold standard, and this was taken into account when calculating the sample size.” Additionally, they noted that follow-up studies should take into consideration the costs of utilizing assay testing like ImmunoXpert, in order to better assess the financial implications that adopting the technology would have on a health care facility.

Nevertheless, the investigators concluded, “our findings [support] the need for implementation research to examine the added clinical utility of ImmunoXpert to diagnose bacterial infection in clinical care for children with lower respiratory tract infection and fever without source presenting at the hospital.”

Funding for this study was provided by MeMed Diagnostics. Dr. van Houten and coauthors did not report any relevant financial disclosures.

[email protected]

An assay designed to distinguish between bacterial and viral infections of the lower respiratory tract appears effective and shows promise for helping hospital physicians reduce overprescribing of antibiotics to children, a study showed.

“It is often not possible to differentiate between bacterial and nonbacterial disease on the basis of clinical judgment alone, [so] antibiotics are prescribed almost twice as often as required in children with acute respiratory tract infections in the USA,” wrote Chantal B. van Houten of the University Medical Centre Utrecht (the Netherlands) and associates in a study published in the Lancet Infectious Diseases.

The assay in question is called ImmunoXpert, which uses three biomarkers – tumor necrosis factor–related apoptosis-inducing ligand (TRAIL), interferon-gamma–induced protein-10 (IP-10), and C-reactive protein (CRP) – to determine if a lower respiratory tract infection has a viral or bacterial origin. A total of 777 subjects, aged 2-60 months, were recruited from four hospitals in the Netherlands and two hospitals in Israel between October 16, 2013, and March 1, 2015 (Lancet Inf Dis. 2016 Dec. doi: 10.1016/S1473-3099(16)30519-9).

The patients all had fevers with unidentified sources when they presented, and had a follow-up assessment carried out 28 days after baseline. Blood samples and nasal swabs were collected within 24 hours of presentation for assay analysis. Additionally, every subject was diagnosed as “bacterial” or “viral” by a three-member panel of pediatricians, whose diagnoses were based on the data available from the follow-up assessment and from clinical and laboratory data. The panel diagnosis for each subject was used as the reference standard.

Of the 777 subjects initially recruited, 200 were excluded from the final analysis for various reasons. Of the 577 who remained, the panel diagnosed 435 as having a viral infection and 71 as having a bacterial infection; 71 were deemed “inconclusive.” The panel was unanimous in 354 of these cases, and a majority of the panel (two of the three experts) agreed in 443 of these cases. In unanimous cases, the sensitivity of distinguishing between viral and bacterial cases correctly was 87.8%, with a specificity of 93.0%. The panel’s positive and negative predictive value were 62.1% and 98.3%, respectively.

The assay’s sensitivity rate in distinguishing between viral and bacterial infections was very close: 86.7%, with a specificity of 91.1%, which the authors noted was “promising diagnostic accuracy.” The positive predictive value of the assay was 60.5%, while the negative predictive value was found to be 97.8%.

Regarding the 71 cases that were deemed “inconclusive,” Dr. van Houten and coauthors acknowledged that “such inconclusive cases are inherent to studies without a gold standard, and this was taken into account when calculating the sample size.” Additionally, they noted that follow-up studies should take into consideration the costs of utilizing assay testing like ImmunoXpert, in order to better assess the financial implications that adopting the technology would have on a health care facility.

Nevertheless, the investigators concluded, “our findings [support] the need for implementation research to examine the added clinical utility of ImmunoXpert to diagnose bacterial infection in clinical care for children with lower respiratory tract infection and fever without source presenting at the hospital.”

Funding for this study was provided by MeMed Diagnostics. Dr. van Houten and coauthors did not report any relevant financial disclosures.

[email protected]

An assay designed to distinguish between bacterial and viral infections of the lower respiratory tract appears effective and shows promise for helping hospital physicians reduce overprescribing of antibiotics to children, a study showed.

“It is often not possible to differentiate between bacterial and nonbacterial disease on the basis of clinical judgment alone, [so] antibiotics are prescribed almost twice as often as required in children with acute respiratory tract infections in the USA,” wrote Chantal B. van Houten of the University Medical Centre Utrecht (the Netherlands) and associates in a study published in the Lancet Infectious Diseases.

The assay in question is called ImmunoXpert, which uses three biomarkers – tumor necrosis factor–related apoptosis-inducing ligand (TRAIL), interferon-gamma–induced protein-10 (IP-10), and C-reactive protein (CRP) – to determine if a lower respiratory tract infection has a viral or bacterial origin. A total of 777 subjects, aged 2-60 months, were recruited from four hospitals in the Netherlands and two hospitals in Israel between October 16, 2013, and March 1, 2015 (Lancet Inf Dis. 2016 Dec. doi: 10.1016/S1473-3099(16)30519-9).

The patients all had fevers with unidentified sources when they presented, and had a follow-up assessment carried out 28 days after baseline. Blood samples and nasal swabs were collected within 24 hours of presentation for assay analysis. Additionally, every subject was diagnosed as “bacterial” or “viral” by a three-member panel of pediatricians, whose diagnoses were based on the data available from the follow-up assessment and from clinical and laboratory data. The panel diagnosis for each subject was used as the reference standard.

Of the 777 subjects initially recruited, 200 were excluded from the final analysis for various reasons. Of the 577 who remained, the panel diagnosed 435 as having a viral infection and 71 as having a bacterial infection; 71 were deemed “inconclusive.” The panel was unanimous in 354 of these cases, and a majority of the panel (two of the three experts) agreed in 443 of these cases. In unanimous cases, the sensitivity of distinguishing between viral and bacterial cases correctly was 87.8%, with a specificity of 93.0%. The panel’s positive and negative predictive value were 62.1% and 98.3%, respectively.

The assay’s sensitivity rate in distinguishing between viral and bacterial infections was very close: 86.7%, with a specificity of 91.1%, which the authors noted was “promising diagnostic accuracy.” The positive predictive value of the assay was 60.5%, while the negative predictive value was found to be 97.8%.

Regarding the 71 cases that were deemed “inconclusive,” Dr. van Houten and coauthors acknowledged that “such inconclusive cases are inherent to studies without a gold standard, and this was taken into account when calculating the sample size.” Additionally, they noted that follow-up studies should take into consideration the costs of utilizing assay testing like ImmunoXpert, in order to better assess the financial implications that adopting the technology would have on a health care facility.

Nevertheless, the investigators concluded, “our findings [support] the need for implementation research to examine the added clinical utility of ImmunoXpert to diagnose bacterial infection in clinical care for children with lower respiratory tract infection and fever without source presenting at the hospital.”

Funding for this study was provided by MeMed Diagnostics. Dr. van Houten and coauthors did not report any relevant financial disclosures.

[email protected]

CHICAGO – Applying the key principles for limiting radiation exposure for vascular surgeons and staff – not to mention patients – during endovascular procedures involves a thorough understanding of dose metrics as well as risk factors for high-dose interventions, according to recent findings reported at a symposium on vascular surgery sponsored by Northwestern University.

Melissa Kirkwood, MD, of the University of Texas Southwestern Medical Center in Dallas, reported on her institution’s experience with limiting radiation exposure in typically high-dose cases. “What we found was that even though we had a substantial amount of dose in these cases – they included a significant proportion of 5- to 10-Gy and greater than 10-Gy cases – there were still no skin injuries detected in these patients,” she said, referencing retrospective and prospective analyses (J Vasc Surg. 2014;60:742-8; J Vasc Surg. 2015;61:902-6).

CHICAGO – Applying the key principles for limiting radiation exposure for vascular surgeons and staff – not to mention patients – during endovascular procedures involves a thorough understanding of dose metrics as well as risk factors for high-dose interventions, according to recent findings reported at a symposium on vascular surgery sponsored by Northwestern University.

Melissa Kirkwood, MD, of the University of Texas Southwestern Medical Center in Dallas, reported on her institution’s experience with limiting radiation exposure in typically high-dose cases. “What we found was that even though we had a substantial amount of dose in these cases – they included a significant proportion of 5- to 10-Gy and greater than 10-Gy cases – there were still no skin injuries detected in these patients,” she said, referencing retrospective and prospective analyses (J Vasc Surg. 2014;60:742-8; J Vasc Surg. 2015;61:902-6).

CHICAGO – Applying the key principles for limiting radiation exposure for vascular surgeons and staff – not to mention patients – during endovascular procedures involves a thorough understanding of dose metrics as well as risk factors for high-dose interventions, according to recent findings reported at a symposium on vascular surgery sponsored by Northwestern University.

Melissa Kirkwood, MD, of the University of Texas Southwestern Medical Center in Dallas, reported on her institution’s experience with limiting radiation exposure in typically high-dose cases. “What we found was that even though we had a substantial amount of dose in these cases – they included a significant proportion of 5- to 10-Gy and greater than 10-Gy cases – there were still no skin injuries detected in these patients,” she said, referencing retrospective and prospective analyses (J Vasc Surg. 2014;60:742-8; J Vasc Surg. 2015;61:902-6).