Κυριακή 19 Νοεμβρίου 2017
First bite syndrome following transcervical arterial ligation after transoral robotic surgery
Objective
To assess the incidence of first bite syndrome (FBS) in transoral robotic surgical (TORS) patients undergoing transcervical arterial ligation.
Methods
Retrospective case series of all patients diagnosed with FBS following prophylactic transcervical arterial ligation of branches of the external carotid system between March 2010 and December 2016 at a single academic center.
Results
Six patients with FBS after TORS with transcervical arterial ligation were evaluated, representing 7% of all patients who underwent neck dissection with concomitant transcervical arterial ligation (6 of 83). Median presentation of FBS was 63 days, with an average duration of 66 days. Treatment ranged from observation to botulinum toxin injection.
Conclusion
Patients who undergo transcervical arterial ligation to minimize bleeding complications following TORS are at risk of developing first bite syndrome.
Level of Evidence
4. Laryngoscope, 2017
http://ift.tt/2AVJcBa
The hospital otolaryngologist: The louisiana state university experience
Objectives/Hypothesis
To describe the implementation and impact of a hospital otolaryngologist in an academic medical center setting. Our hypothesis was that the hospital otolaryngologist would increase productivity of the Louisiana State University (LSU) faculty otolaryngologists and provide more timely access to inpatient otolaryngology services.
Study Design
Retrospective clinical and administrative database review.
Methods
A comparative database review was performed with data from the year predating the initiation of the hospitalist program (2013) to the first full year after initiation of the program (2014). A clinical database review including diagnoses and procedures was also performed.
Results
Overall outpatient clinic relative value units for the aggregated LSU faculty increased 16% (despite the fact that the direct outpatient contribution of the hospital otolaryngologist was negligible). Overall capture of inpatient consult codes increased 128%. The hospital otolaryngologist was responsible for 84.5% of inpatient consult codes. There was a 100% increase in outpatient consult codes for the LSU faculty, of which <1% was attributed to the otolaryngology hospitalist. No significant impact was seen on length of stay over the study interval. Clinical database review of the first 2 years of the program showed 3,707 total encounters with postoperative encounters the most common. Four hundred fifty-four inpatient procedures were logged. The most common surgical procedure was tracheostomy.
Conclusions
The otolaryngology hospitalist program is a viable clinical and economic model.
Level of Evidence
NA Laryngoscope, 2017
http://ift.tt/2ivPv7S
Hirano's cover–body model and its unique laryngeal postures revisited
Objectives/Hypothesis
In 1974, Minoru Hirano proposed his theory of voice production that is now known as the cover–body theory. He described the thyroarytenoid (TA) and cricothyroid (CT) muscles as the major determinants of vocal fold shape and stiffness, and theorized four typical laryngeal configurations resulting from unique TA/CT activations, with implications for the resulting voice quality. In this study, we directly observed the vocal fold medial surface shape under Hirano's unique TA/CT activation conditions to obtain a three-dimensional (3D) understanding of these laryngeal configurations during muscle activation.
Study Design
In vivo canine hemilarynx model.
Methods
Flesh points were marked along the medial surface of the vocal fold. Selective TA and CT activation were performed via respective laryngeal nerves. 3D reconstructions of the vocal fold medial surface were derived using digital image correlation.
Results
Low level TA and CT activation yielded anteroposterior lengthening and vertical thinning of the vocal fold. When TA activation is far greater than CT, the vocal fold shortens and thickens. With slightly greater TA than CT, activation the vocal length is maintained on average, whereas its vertical thickness decreases. With CT far greater than TA activation, the vocal fold lengthens and thins. In all conditions, glottal contour changes remained minimal.
Conclusions
Analysis of the 3D geometry of the vocal fold medial surface under Hirano's four typical laryngeal configurations revealed that the key geometric changes during TA/CT interactions lie within the anteroposterior length and the vertical thickness of the vocal fold.
Level of Evidence
NA Laryngoscope, 2017
http://ift.tt/2AUCETh
The national landscape of unplanned 30-day readmissions after total laryngectomy
Objectives/Hypothesis
Examine rates of readmission after total laryngectomy and determine primary etiologies, timing, and risk factors for unplanned readmission.
Study Design
Retrospective cohort study.
Methods
The Nationwide Readmissions Database was queried for patients who underwent total laryngectomy between January 2013 and November 2013. Patient-, procedure-, admission-, and institution-level characteristics were compared for patients with and without unplanned 30-day readmission. Outcomes of interest included rates, etiology, and timing of readmission. Multivariate logistic regression was used to identify predictors of 30-day readmission.
Results
There were 2,931 total laryngectomies performed in 2013 with an unplanned readmission rate of 17.5%. Postoperative fistula accounted for 13.7% of readmissions. The odds of readmission were elevated for patients undergoing concurrent procedures, including primary tracheoesophageal fistulization (adjusted odds ratio [aOR]: 2.44, 95% confidence interval [CI]: 1.15-5.18, P = .02) and/or pedicle graft or flap procedures (aOR: 1.73, 95% CI: 1.13-2.66, P = .01). Additionally, patients with comorbid coagulopathy (aOR: 3.04, 95% CI: 1.13-8.22, P = .03), liver disease (aOR: 2.48, 95% CI: 1.08-5.71, P = .03), and valvular heart disease (aOR: 3.18, 95% CI: 1.20-8.41, P = .02) had increased risk for unplanned 30-day readmission. Private insurance and longer lengths of stay were associated with decreased odds of readmission.
Conclusions
Nearly one-fifth of total laryngectomy patients are readmitted to the hospital within 30 days of discharge. Risk factors identified in this nationally representative cohort should be carefully considered during the postoperative period to reduce preventable readmissions after total laryngectomy.
Level of Evidence
2c Laryngoscope, 2017
http://ift.tt/2ixoJvN
Effect of topical nasal anesthetic on swallowing in healthy adults: A double-blind, high-resolution manometry study
Objective
Topical nasal anesthetic (TNA) is used when evaluating pharyngeal swallowing with high-resolution manometry (HRM). It is unclear if desensitizing the nasal mucosa improves procedure tolerability or affects pharyngeal pressure. This study evaluated the effects of TNA on comfort and pharyngeal pressure using HRM.
Methods
A double-blinded study was conducted with 20 healthy participants ( = 27 years). Participants performed five saliva and five 10-mL swallows during two exams with ManoScan HRM ESO catheter (Medtronic, Minneapolis, MN) randomized under placebo (nonanesthetic lubricant) and anesthetized (0.4 mL of 2% viscous lidocaine hydrochloride) conditions. Comfort was rated using a 100-mm visual analog scale (VAS). Pharyngeal HRM amplitude and timing were analyzed.
Results
VAS ratings were similar under placebo (mean = 38.4, standard deviation [SD] = 19.92) and TNA conditions (mean = 33.78, SD = 18.9), with no significant differences between placebo and anesthetized conditions (t[19] = 1.23, P = 0.23) or tolerability at first and second procedure (t[19] = 1.38, P = 0.18). Lower maximum and mean pharyngeal pressure were found for the TNA condition when compared to placebo (dry: maximum [−15.45 mmHg, standard error (SE) = 5.06 mmHg, P = 0.021]; mean [−5.22 mmHg, SE = 1.58 mmHg, P = 0.005]), and (liquid: maximum [−14.79 mmHg, SE = 5.01 mmHg, P = 0.010]; mean [−2.79 mmHg, SE = 1.99 mmHg, P = 0.008]).
Conclusion
This double-blind, randomized study is the first to investigate effects of TNA on tolerability and pharyngeal pressure using HRM. Results indicate TNA offered no significant difference in procedure comfort while affecting the magnitude of pharyngeal swallowing.
Level of Evidence
4. Laryngoscope, 2017
http://ift.tt/2AVUuFw
Healthcare disparities in pediatric otolaryngology: A systematic review
Objectives
Multiple studies have reported healthcare disparities in particular settings and conditions within pediatric otolaryngology, but a systematic examination of the breadth of the problem within the field is lacking. This study's objectives are to synthesize the available evidence regarding healthcare disparities in pediatric otolaryngology, highlight recurrent themes with respect to etiologies and manifestations, and demonstrate potential impacts from patient and provider standpoints.
Methods
A qualitative systematic review of the PubMed, Ovid, and Cochrane databases for articles focusing on racial, ethnic, or socioeconomic disparities related to pediatric otolaryngology conditions or settings was conducted. United States-based studies of any design or publication date with analysis of children 0 to 18 years old were included.
Results
Of 711 abstracts identified, 39 met inclusion criteria. Manual review of references from these articles yielded 22 additional studies, for a total of 61. Disparities were identified in nearly every subspecialty within pediatric otolaryngology, with otologic conditions the most frequently studied (33 of 61). The most commonly cited disparities involved low socioeconomic status (25 of 61), inadequate insurance (23 of 61), nonwhite race (21 of 61), and barriers to accessing care (21 of 61). Only six articles found no disparities regarding the condition examined in their study.
Conclusion
Through a variety of study topics, designs, and settings, a growing body of literature documents disparities across the spectrum of pediatric otolaryngology care. The etiologies and manifestations of such disparities are myriad. This evidence suggests the need for interventions to address these disparities at various professional and institutional levels, ideally with methodological rigor to assess the effectiveness of such interventions. Laryngoscope, 2017
http://ift.tt/2iw3OJs
Comparison of pediatric adenoidectomy techniques
Objectives
Evaluate the effects of electrocautery, microdebrider, and coblation techniques on outpatient pediatric adenoidectomy costs and complications.
Study Design
Observational retrospective cohort study.
Methods
An observational cohort study was performed in a multihospital network using a standardized accounting system. Children < 18 years of age who underwent outpatient adenoidectomy were included from January 2008 to September 2015. Cases with additional procedures were excluded. The cohorts were divided into children who underwent electrocautery, microdebrider, or coblator adenoidectomy. Data regarding costs, postoperative complications, and revision surgeries were analyzed.
Results
A total of 1,065 cases of adenoidectomy were performed with electrocautery (34.9%), microdebrider (26.1%), and coblation (39.0%). There was an increased after direct cost associated with the microdebrider, $833 (standard deviation [SD] $363) and the coblator, $797 (SD $262) compared to the electrocautery, $597 (SD $361) (P < 0.0001). There was a greater overall operating room (OR) time associated with use of the microdebrider (mean 28.7, SD 11.0 minutes) compared with both the electrocautery (mean 24.7, SD 8.1 minutes) and coblator (mean 26.2, SD 9.8 minutes) (P < 0.0001). No significant difference was found with regard to complication rates. The incidence of repeat adenoidectomies was significantly greater for microdebrider (9.7%) compared to electrocautery (2.7%; P = 0.0002) and coblator (5.3%; P = 0.0336) techniques.
Conclusion
These results suggest that adenoidectomy with electrocautery is significantly less expensive than microdebrider and coblator, with no differences in complication rates or surgical times among the techniques. Microdebrider adenoidectomy was associated with a longer overall OR time and a higher rate of adenoid regrowth, requiring revision surgery.
Level of Evidence
4. Laryngoscope, 2017
http://ift.tt/2AUGHPs
Impact of an oral appliance on obstructive sleep apnea severity, quality of life, and biomarkers
Objective/Hypothesis
To investigate outcomes including efficacy, quality of life, and levels of inflammatory markers of a mandibular advancement device (MAD) for moderate-to-severe obstructive sleep apnea (OSA).
Study Design
Case-control study.
Methods
Patients with apnea-hypopnea index (AHI) ≥ 15/hr who only accepted MAD therapy (study group) or who refused any treatment (control group) were recruited. At baseline and at 6 months, polysomnography, Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), C-reactive protein (CRP), interleukin 1β, interleukin 6, and tumor necrosis factor α (TNF-α) were assessed in both groups.
Results
At baseline, the study group (n = 30) showed a higher percentage of rapid eye movement sleep and higher CRP levels (P < .05) than the control group (n = 10). At 6 months, the MAD significantly improved AHI and lowest oxygen saturation (P < .01), non–rapid eye movement (N)1 and N3 sleep stages (P < .05), ESS score (P < .05), FOSQ total score (P < .01), interleukin 1β (P < .05), and TNF-α (P < .01) compared with the untreated group. In the overall, moderate, and severe OSA groups, 63.3%, 75%, and 50%, respectively, achieved at least good response.
Conclusions
Use of a MAD significantly improved polysomnographic parameters, quality of life, and some inflammatory markers (CRP, IL-β, and TNF-α) in a significant proportion of patients with moderate OSA and in some patients with severe OSA. Hence, a MAD may be a viable alternative therapy in patients with moderate-to-severe OSA who refuse continuous positive airway pressure.
Level of Evidence
3b Laryngoscope, 2017
http://ift.tt/2izgVtB
Referral patterns from emergency department to otolaryngology clinic
Objectives/Hypothesis
Patients who present to the emergency department (ED) with various otolaryngologic disorders are frequently referred to an otolaryngologist for follow-up care. Our aim was to further characterize this group as it has not been well described in the literature.
Study Design
Cross-sectional retrospective study.
Methods
We reviewed the charts of patients seen during an 18-month period in an urban public hospital trauma center adult ED and referred to an otolaryngology clinic for follow-up care.
Results
Seven hundred thirty-eight patients were seen and referred; the most common diagnoses made by ED providers were peripheral vertigo (12%), otitis externa (8%), and nasal fractures (8%). Nine percent of patients were evaluated during their ED visit by an otolaryngology provider. Three hundred seventy-two (50%) patients returned for their otolaryngology clinic visit; facial trauma patients were least likely to return. The most common diagnoses made by otolaryngology providers were otitis externa (12%), peripheral vertigo (12%), and nasal fractures (7%). There was 50% concordance between patients' diagnoses made by ED and otolaryngology providers. The most common differences were otitis media versus otitis externa (10%) and acute pharyngitis versus laryngopharyngeal reflux (8%). During 37% of follow-up visits, an in-office procedure was performed, most commonly flexible fiberoptic laryngoscopy, cerumen removal, and nasal endoscopy.
Conclusions
Our analysis reports comprehensive characteristics of this referral group, identifying potential areas for improvement in patient management, resident education and efficiency. Otolaryngologists covering EDs should be familiar with this population in terms of types of cases that may affect their practices.
Level of Evidence
4. Laryngoscope, 2017
http://ift.tt/2AVUe9w
First bite syndrome following transcervical arterial ligation after transoral robotic surgery
Objective
To assess the incidence of first bite syndrome (FBS) in transoral robotic surgical (TORS) patients undergoing transcervical arterial ligation.
Methods
Retrospective case series of all patients diagnosed with FBS following prophylactic transcervical arterial ligation of branches of the external carotid system between March 2010 and December 2016 at a single academic center.
Results
Six patients with FBS after TORS with transcervical arterial ligation were evaluated, representing 7% of all patients who underwent neck dissection with concomitant transcervical arterial ligation (6 of 83). Median presentation of FBS was 63 days, with an average duration of 66 days. Treatment ranged from observation to botulinum toxin injection.
Conclusion
Patients who undergo transcervical arterial ligation to minimize bleeding complications following TORS are at risk of developing first bite syndrome.
Level of Evidence
4. Laryngoscope, 2017
http://ift.tt/2AVJcBa
The hospital otolaryngologist: The louisiana state university experience
Objectives/Hypothesis
To describe the implementation and impact of a hospital otolaryngologist in an academic medical center setting. Our hypothesis was that the hospital otolaryngologist would increase productivity of the Louisiana State University (LSU) faculty otolaryngologists and provide more timely access to inpatient otolaryngology services.
Study Design
Retrospective clinical and administrative database review.
Methods
A comparative database review was performed with data from the year predating the initiation of the hospitalist program (2013) to the first full year after initiation of the program (2014). A clinical database review including diagnoses and procedures was also performed.
Results
Overall outpatient clinic relative value units for the aggregated LSU faculty increased 16% (despite the fact that the direct outpatient contribution of the hospital otolaryngologist was negligible). Overall capture of inpatient consult codes increased 128%. The hospital otolaryngologist was responsible for 84.5% of inpatient consult codes. There was a 100% increase in outpatient consult codes for the LSU faculty, of which <1% was attributed to the otolaryngology hospitalist. No significant impact was seen on length of stay over the study interval. Clinical database review of the first 2 years of the program showed 3,707 total encounters with postoperative encounters the most common. Four hundred fifty-four inpatient procedures were logged. The most common surgical procedure was tracheostomy.
Conclusions
The otolaryngology hospitalist program is a viable clinical and economic model.
Level of Evidence
NA Laryngoscope, 2017
http://ift.tt/2ivPv7S
Hirano's cover–body model and its unique laryngeal postures revisited
Objectives/Hypothesis
In 1974, Minoru Hirano proposed his theory of voice production that is now known as the cover–body theory. He described the thyroarytenoid (TA) and cricothyroid (CT) muscles as the major determinants of vocal fold shape and stiffness, and theorized four typical laryngeal configurations resulting from unique TA/CT activations, with implications for the resulting voice quality. In this study, we directly observed the vocal fold medial surface shape under Hirano's unique TA/CT activation conditions to obtain a three-dimensional (3D) understanding of these laryngeal configurations during muscle activation.
Study Design
In vivo canine hemilarynx model.
Methods
Flesh points were marked along the medial surface of the vocal fold. Selective TA and CT activation were performed via respective laryngeal nerves. 3D reconstructions of the vocal fold medial surface were derived using digital image correlation.
Results
Low level TA and CT activation yielded anteroposterior lengthening and vertical thinning of the vocal fold. When TA activation is far greater than CT, the vocal fold shortens and thickens. With slightly greater TA than CT, activation the vocal length is maintained on average, whereas its vertical thickness decreases. With CT far greater than TA activation, the vocal fold lengthens and thins. In all conditions, glottal contour changes remained minimal.
Conclusions
Analysis of the 3D geometry of the vocal fold medial surface under Hirano's four typical laryngeal configurations revealed that the key geometric changes during TA/CT interactions lie within the anteroposterior length and the vertical thickness of the vocal fold.
Level of Evidence
NA Laryngoscope, 2017
http://ift.tt/2AUCETh
The national landscape of unplanned 30-day readmissions after total laryngectomy
Objectives/Hypothesis
Examine rates of readmission after total laryngectomy and determine primary etiologies, timing, and risk factors for unplanned readmission.
Study Design
Retrospective cohort study.
Methods
The Nationwide Readmissions Database was queried for patients who underwent total laryngectomy between January 2013 and November 2013. Patient-, procedure-, admission-, and institution-level characteristics were compared for patients with and without unplanned 30-day readmission. Outcomes of interest included rates, etiology, and timing of readmission. Multivariate logistic regression was used to identify predictors of 30-day readmission.
Results
There were 2,931 total laryngectomies performed in 2013 with an unplanned readmission rate of 17.5%. Postoperative fistula accounted for 13.7% of readmissions. The odds of readmission were elevated for patients undergoing concurrent procedures, including primary tracheoesophageal fistulization (adjusted odds ratio [aOR]: 2.44, 95% confidence interval [CI]: 1.15-5.18, P = .02) and/or pedicle graft or flap procedures (aOR: 1.73, 95% CI: 1.13-2.66, P = .01). Additionally, patients with comorbid coagulopathy (aOR: 3.04, 95% CI: 1.13-8.22, P = .03), liver disease (aOR: 2.48, 95% CI: 1.08-5.71, P = .03), and valvular heart disease (aOR: 3.18, 95% CI: 1.20-8.41, P = .02) had increased risk for unplanned 30-day readmission. Private insurance and longer lengths of stay were associated with decreased odds of readmission.
Conclusions
Nearly one-fifth of total laryngectomy patients are readmitted to the hospital within 30 days of discharge. Risk factors identified in this nationally representative cohort should be carefully considered during the postoperative period to reduce preventable readmissions after total laryngectomy.
Level of Evidence
2c Laryngoscope, 2017
http://ift.tt/2ixoJvN
Effect of topical nasal anesthetic on swallowing in healthy adults: A double-blind, high-resolution manometry study
Objective
Topical nasal anesthetic (TNA) is used when evaluating pharyngeal swallowing with high-resolution manometry (HRM). It is unclear if desensitizing the nasal mucosa improves procedure tolerability or affects pharyngeal pressure. This study evaluated the effects of TNA on comfort and pharyngeal pressure using HRM.
Methods
A double-blinded study was conducted with 20 healthy participants ( = 27 years). Participants performed five saliva and five 10-mL swallows during two exams with ManoScan HRM ESO catheter (Medtronic, Minneapolis, MN) randomized under placebo (nonanesthetic lubricant) and anesthetized (0.4 mL of 2% viscous lidocaine hydrochloride) conditions. Comfort was rated using a 100-mm visual analog scale (VAS). Pharyngeal HRM amplitude and timing were analyzed.
Results
VAS ratings were similar under placebo (mean = 38.4, standard deviation [SD] = 19.92) and TNA conditions (mean = 33.78, SD = 18.9), with no significant differences between placebo and anesthetized conditions (t[19] = 1.23, P = 0.23) or tolerability at first and second procedure (t[19] = 1.38, P = 0.18). Lower maximum and mean pharyngeal pressure were found for the TNA condition when compared to placebo (dry: maximum [−15.45 mmHg, standard error (SE) = 5.06 mmHg, P = 0.021]; mean [−5.22 mmHg, SE = 1.58 mmHg, P = 0.005]), and (liquid: maximum [−14.79 mmHg, SE = 5.01 mmHg, P = 0.010]; mean [−2.79 mmHg, SE = 1.99 mmHg, P = 0.008]).
Conclusion
This double-blind, randomized study is the first to investigate effects of TNA on tolerability and pharyngeal pressure using HRM. Results indicate TNA offered no significant difference in procedure comfort while affecting the magnitude of pharyngeal swallowing.
Level of Evidence
4. Laryngoscope, 2017
http://ift.tt/2AVUuFw
Healthcare disparities in pediatric otolaryngology: A systematic review
Objectives
Multiple studies have reported healthcare disparities in particular settings and conditions within pediatric otolaryngology, but a systematic examination of the breadth of the problem within the field is lacking. This study's objectives are to synthesize the available evidence regarding healthcare disparities in pediatric otolaryngology, highlight recurrent themes with respect to etiologies and manifestations, and demonstrate potential impacts from patient and provider standpoints.
Methods
A qualitative systematic review of the PubMed, Ovid, and Cochrane databases for articles focusing on racial, ethnic, or socioeconomic disparities related to pediatric otolaryngology conditions or settings was conducted. United States-based studies of any design or publication date with analysis of children 0 to 18 years old were included.
Results
Of 711 abstracts identified, 39 met inclusion criteria. Manual review of references from these articles yielded 22 additional studies, for a total of 61. Disparities were identified in nearly every subspecialty within pediatric otolaryngology, with otologic conditions the most frequently studied (33 of 61). The most commonly cited disparities involved low socioeconomic status (25 of 61), inadequate insurance (23 of 61), nonwhite race (21 of 61), and barriers to accessing care (21 of 61). Only six articles found no disparities regarding the condition examined in their study.
Conclusion
Through a variety of study topics, designs, and settings, a growing body of literature documents disparities across the spectrum of pediatric otolaryngology care. The etiologies and manifestations of such disparities are myriad. This evidence suggests the need for interventions to address these disparities at various professional and institutional levels, ideally with methodological rigor to assess the effectiveness of such interventions. Laryngoscope, 2017
http://ift.tt/2iw3OJs
Comparison of pediatric adenoidectomy techniques
Objectives
Evaluate the effects of electrocautery, microdebrider, and coblation techniques on outpatient pediatric adenoidectomy costs and complications.
Study Design
Observational retrospective cohort study.
Methods
An observational cohort study was performed in a multihospital network using a standardized accounting system. Children < 18 years of age who underwent outpatient adenoidectomy were included from January 2008 to September 2015. Cases with additional procedures were excluded. The cohorts were divided into children who underwent electrocautery, microdebrider, or coblator adenoidectomy. Data regarding costs, postoperative complications, and revision surgeries were analyzed.
Results
A total of 1,065 cases of adenoidectomy were performed with electrocautery (34.9%), microdebrider (26.1%), and coblation (39.0%). There was an increased after direct cost associated with the microdebrider, $833 (standard deviation [SD] $363) and the coblator, $797 (SD $262) compared to the electrocautery, $597 (SD $361) (P < 0.0001). There was a greater overall operating room (OR) time associated with use of the microdebrider (mean 28.7, SD 11.0 minutes) compared with both the electrocautery (mean 24.7, SD 8.1 minutes) and coblator (mean 26.2, SD 9.8 minutes) (P < 0.0001). No significant difference was found with regard to complication rates. The incidence of repeat adenoidectomies was significantly greater for microdebrider (9.7%) compared to electrocautery (2.7%; P = 0.0002) and coblator (5.3%; P = 0.0336) techniques.
Conclusion
These results suggest that adenoidectomy with electrocautery is significantly less expensive than microdebrider and coblator, with no differences in complication rates or surgical times among the techniques. Microdebrider adenoidectomy was associated with a longer overall OR time and a higher rate of adenoid regrowth, requiring revision surgery.
Level of Evidence
4. Laryngoscope, 2017
http://ift.tt/2AUGHPs
Impact of an oral appliance on obstructive sleep apnea severity, quality of life, and biomarkers
Objective/Hypothesis
To investigate outcomes including efficacy, quality of life, and levels of inflammatory markers of a mandibular advancement device (MAD) for moderate-to-severe obstructive sleep apnea (OSA).
Study Design
Case-control study.
Methods
Patients with apnea-hypopnea index (AHI) ≥ 15/hr who only accepted MAD therapy (study group) or who refused any treatment (control group) were recruited. At baseline and at 6 months, polysomnography, Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), C-reactive protein (CRP), interleukin 1β, interleukin 6, and tumor necrosis factor α (TNF-α) were assessed in both groups.
Results
At baseline, the study group (n = 30) showed a higher percentage of rapid eye movement sleep and higher CRP levels (P < .05) than the control group (n = 10). At 6 months, the MAD significantly improved AHI and lowest oxygen saturation (P < .01), non–rapid eye movement (N)1 and N3 sleep stages (P < .05), ESS score (P < .05), FOSQ total score (P < .01), interleukin 1β (P < .05), and TNF-α (P < .01) compared with the untreated group. In the overall, moderate, and severe OSA groups, 63.3%, 75%, and 50%, respectively, achieved at least good response.
Conclusions
Use of a MAD significantly improved polysomnographic parameters, quality of life, and some inflammatory markers (CRP, IL-β, and TNF-α) in a significant proportion of patients with moderate OSA and in some patients with severe OSA. Hence, a MAD may be a viable alternative therapy in patients with moderate-to-severe OSA who refuse continuous positive airway pressure.
Level of Evidence
3b Laryngoscope, 2017
http://ift.tt/2izgVtB
Referral patterns from emergency department to otolaryngology clinic
Objectives/Hypothesis
Patients who present to the emergency department (ED) with various otolaryngologic disorders are frequently referred to an otolaryngologist for follow-up care. Our aim was to further characterize this group as it has not been well described in the literature.
Study Design
Cross-sectional retrospective study.
Methods
We reviewed the charts of patients seen during an 18-month period in an urban public hospital trauma center adult ED and referred to an otolaryngology clinic for follow-up care.
Results
Seven hundred thirty-eight patients were seen and referred; the most common diagnoses made by ED providers were peripheral vertigo (12%), otitis externa (8%), and nasal fractures (8%). Nine percent of patients were evaluated during their ED visit by an otolaryngology provider. Three hundred seventy-two (50%) patients returned for their otolaryngology clinic visit; facial trauma patients were least likely to return. The most common diagnoses made by otolaryngology providers were otitis externa (12%), peripheral vertigo (12%), and nasal fractures (7%). There was 50% concordance between patients' diagnoses made by ED and otolaryngology providers. The most common differences were otitis media versus otitis externa (10%) and acute pharyngitis versus laryngopharyngeal reflux (8%). During 37% of follow-up visits, an in-office procedure was performed, most commonly flexible fiberoptic laryngoscopy, cerumen removal, and nasal endoscopy.
Conclusions
Our analysis reports comprehensive characteristics of this referral group, identifying potential areas for improvement in patient management, resident education and efficiency. Otolaryngologists covering EDs should be familiar with this population in terms of types of cases that may affect their practices.
Level of Evidence
4. Laryngoscope, 2017
http://ift.tt/2AVUe9w
Laser treatment of cutaneous angiokeratomas: A systematic review
Abstract
Angiokeratomas can present therapeutic challenges, especially in cases of extensive lesions, where traditional surgical methods carry high risks of scarring and hemorrhage. Argon, pulsed dye (PDL), neodymium-doped yttrium aluminum garnet (Nd:YAG), copper vapor, potassium titanyl phosphate, carbon dioxide, and erbium-doped yttrium aluminum garnet (Er:YAG) lasers have emerged as alternative options. To review the use and efficacy of lasers in treating angiokeratomas. A PubMed search identified randomized clinical trials, cohort studies, case series, and case reports involving laser treatment of cutaneous angiokeratomas. Twenty-five studies were included. Quality ratings were assigned using the Oxford Centre for Evidence-Based Medicine scheme. Several laser modalities are effective in treating multiple variants of angiokeratomas. Vascular lasers like PDL, Nd:YAG, and argon are the most studied and of these, PDL offers the safest side effect profile. Nd:YAG may be more effective for hyperkeratotic angiokeratomas. Combination treatment with multiple laser modalities has also demonstrated some success. Lasers are a promising treatment option for angiokeratomas, but current use is limited by the lack of treatment guidelines. There are limited high quality studies comparing laser treatments to each other and to non-laser options. Additional studies are needed to establish guidelines and to optimize laser parameters.
http://ift.tt/2z1slwl
Laser treatment of cutaneous angiokeratomas: A systematic review
Abstract
Angiokeratomas can present therapeutic challenges, especially in cases of extensive lesions, where traditional surgical methods carry high risks of scarring and hemorrhage. Argon, pulsed dye (PDL), neodymium-doped yttrium aluminum garnet (Nd:YAG), copper vapor, potassium titanyl phosphate, carbon dioxide, and erbium-doped yttrium aluminum garnet (Er:YAG) lasers have emerged as alternative options. To review the use and efficacy of lasers in treating angiokeratomas. A PubMed search identified randomized clinical trials, cohort studies, case series, and case reports involving laser treatment of cutaneous angiokeratomas. Twenty-five studies were included. Quality ratings were assigned using the Oxford Centre for Evidence-Based Medicine scheme. Several laser modalities are effective in treating multiple variants of angiokeratomas. Vascular lasers like PDL, Nd:YAG, and argon are the most studied and of these, PDL offers the safest side effect profile. Nd:YAG may be more effective for hyperkeratotic angiokeratomas. Combination treatment with multiple laser modalities has also demonstrated some success. Lasers are a promising treatment option for angiokeratomas, but current use is limited by the lack of treatment guidelines. There are limited high quality studies comparing laser treatments to each other and to non-laser options. Additional studies are needed to establish guidelines and to optimize laser parameters.
http://ift.tt/2z1slwl
Cosmeceutical effect of ethyl acetate fraction of Kombucha tea by intradermal administration in the skin of aged mice
Summary
Background/purpose
Natural ingredients have been always an interesting approach to prolong youthful appearance of skin. One of the natural compounds is Kombucha tea (KT), which has been mainly used as an energy drink in Asian countries for a long time. Previous reports indicated that it has pharmaceutical and favorable wound repairing effects. The beneficial properties of KT are thought to be mainly due to the presence of fermentation products such as flavonoids and other polyphenols with inhibition of hydrolytic and oxidative enzymes and anti-inflammatory effects. These properties prompted us to study the anti-aging potential of KT and investigate its effective fraction in aged mice,
Methods
Kombucha tea was fractionated into chloroform, butanol, and ethyl acetate, and flavonoid content was determined. Young and old mice were used as control. KT ethyl acetate fraction (KEAf), which had the highest flavonoid content, was intradermally administered to old mice.
Results
Administration of KEAf significantly increased the collagen content, NAD+/NADH level, and concomitantly improved skin connective tissue abnormalities in the aged skin. No sensitivity or irritation was observed.
Conclusion
This finding suggested that KEAf can be a suitable candidate as a cosmetic product to improve aging-related skin abnormalities and regeneration of aged skin.
http://ift.tt/2mJtczS
Skin care and cosmeceuticals: Attitudes and trends among trainees and educators
Summary
Introduction
Patients often seek skin care recommendations from their dermatologist. The objective of this study was to determine the degree of education dermatology residents receive on skin care and cosmeceutical products, the source of education, and the attitude of trainees and their educators toward skin care and cosmeceuticals.
Methods
A cross-sectional survey of dermatology residents and faculty via an online survey administered June 2015 and August 2015, respectively.
Results
In total, 104 dermatology residents and 50 dermatology faculty members completed the survey. Among the dermatology residents and faculty, equal distribution was represented across the country. The majority of residents and faculty (62% and 69%, respectively) report discussing skin care with up to 25% of their patients. Among resident participants, 76.5% "agree or strongly agree" that skin care and cosmeceutical education should be part of their education and the majority of residents (74.5%) report their education has been "too little or nonexistent" during residency. In contrast, the majority of the faculty (60%) reports their resident education is "just the right amount or too much" (P < .001).
Conclusions
Skin care and cosmeceutical recommendations are often discussed in dermatology visits. Dermatology residents feel that education on these products should be a part of their residency training.
http://ift.tt/2zjTfUp
Cosmeceutical effect of ethyl acetate fraction of Kombucha tea by intradermal administration in the skin of aged mice
Summary
Background/purpose
Natural ingredients have been always an interesting approach to prolong youthful appearance of skin. One of the natural compounds is Kombucha tea (KT), which has been mainly used as an energy drink in Asian countries for a long time. Previous reports indicated that it has pharmaceutical and favorable wound repairing effects. The beneficial properties of KT are thought to be mainly due to the presence of fermentation products such as flavonoids and other polyphenols with inhibition of hydrolytic and oxidative enzymes and anti-inflammatory effects. These properties prompted us to study the anti-aging potential of KT and investigate its effective fraction in aged mice,
Methods
Kombucha tea was fractionated into chloroform, butanol, and ethyl acetate, and flavonoid content was determined. Young and old mice were used as control. KT ethyl acetate fraction (KEAf), which had the highest flavonoid content, was intradermally administered to old mice.
Results
Administration of KEAf significantly increased the collagen content, NAD+/NADH level, and concomitantly improved skin connective tissue abnormalities in the aged skin. No sensitivity or irritation was observed.
Conclusion
This finding suggested that KEAf can be a suitable candidate as a cosmetic product to improve aging-related skin abnormalities and regeneration of aged skin.
http://ift.tt/2mJtczS
Skin care and cosmeceuticals: Attitudes and trends among trainees and educators
Summary
Introduction
Patients often seek skin care recommendations from their dermatologist. The objective of this study was to determine the degree of education dermatology residents receive on skin care and cosmeceutical products, the source of education, and the attitude of trainees and their educators toward skin care and cosmeceuticals.
Methods
A cross-sectional survey of dermatology residents and faculty via an online survey administered June 2015 and August 2015, respectively.
Results
In total, 104 dermatology residents and 50 dermatology faculty members completed the survey. Among the dermatology residents and faculty, equal distribution was represented across the country. The majority of residents and faculty (62% and 69%, respectively) report discussing skin care with up to 25% of their patients. Among resident participants, 76.5% "agree or strongly agree" that skin care and cosmeceutical education should be part of their education and the majority of residents (74.5%) report their education has been "too little or nonexistent" during residency. In contrast, the majority of the faculty (60%) reports their resident education is "just the right amount or too much" (P < .001).
Conclusions
Skin care and cosmeceutical recommendations are often discussed in dermatology visits. Dermatology residents feel that education on these products should be a part of their residency training.
http://ift.tt/2zjTfUp
Magnesium sulfate and ophthalmic artery Doppler velocimetry in patients with severe preeclampsia: a case series
In the present study, we used Doppler velocimetry in the ophthalmic artery to evaluate the hemodynamic status of the intracranial vasculature. This is the first time in the literature that indices of ophthalmi...
http://ift.tt/2zXo8Lg
Clinical Thyroidology for the Public – Highlighted Article
From Clinical Thyroidology for the Public: Overall, thyroid blood testing has steadily increased over the past few decades, corresponding with rising healthcare costs. Many thyroid tests are overused and may be inappropriate for the type of thyroid condition suspected. Read More….
We welcome your feedback and suggestions. Let us know what you want to see in this publication.
Feedback & SuggestionsThe post Clinical Thyroidology for the Public – Highlighted Article appeared first on American Thyroid Association.
http://ift.tt/2j8OcLt
Clinical Thyroidology for the Public – Highlighted Article
From Clinical Thyroidology for the Public: Overall, thyroid blood testing has steadily increased over the past few decades, corresponding with rising healthcare costs. Many thyroid tests are overused and may be inappropriate for the type of thyroid condition suspected. Read More….
We welcome your feedback and suggestions. Let us know what you want to see in this publication.
Feedback & SuggestionsThe post Clinical Thyroidology for the Public – Highlighted Article appeared first on American Thyroid Association.
http://ift.tt/2j8OcLt
Standardised noxious stimulation-guided individual adjustment of remifentanil target-controlled infusion to prevent haemodynamic responses to laryngoscopy and surgical incision: A randomised controlled trial
BACKGROUND The surgical plethysmographic index (SPI) is one of the available indexes of the nociception–antinociception (NAN) balance. Individually adjusting the NAN balance to prevent somatic responses to noxious stimulation remains a challenge. OBJECTIVES To assess whether guiding remifentanil administration according to the SPI response to a calibrated noxious stimulus (NANCAL) can blunt the haemodynamic response to tracheal intubation and surgical incision. DESIGN Prospective randomised multicentre controlled study. SETTING Two Belgian university hospitals from January 2014 to April 2015. PATIENTS After ethic review board approval and informed consent, 48 American Society of Anesthesiologists I or II adult patients scheduled for surgery under general anaesthesia were enrolled. INTERVENTIONS Patients were randomly assigned to a SPI group, where remifentanil effect-site concentration was adjusted according to NANCAL, or a control group, where it was fixed at 4 ng ml−1. Propofol concentration was always adjusted to maintain the bispectral index close to 40. NANCAL consisted of a 100 Hz, 60 mA electrical tetanic stimulation during 30 s at the wrist before tracheal intubation and before surgical incision. MAIN OUTCOME MEASURES The primary endpoint was the efficacy of the NANCAL-guided remifentanil administration to prevent the haemodynamic response to tracheal intubation and surgical incision. The secondary aim was to compare the ability of SPI, analgesia nociception index, pupil diameter and mean arterial pressure response to NANCAL to predict the haemodynamic response to tracheal intubation and surgical incision. RESULTS Our SPI response to NANCAL-based correcting scheme for remifentanil administration was not superior to a fixed remifentanil concentration at blunting the haemodynamic response to tracheal intubation or surgical incision. Among all tested NAN balance indices, only mean arterial pressure had significant predictive ability with regard to the haemodynamic response to surgical incision. CONCLUSION Further research is needed to define the best NANCAL stimulus and the best remifentanil correcting scheme to help individualised tailoring of antinociception for each specific subpopulation of surgical patients. TRIAL REGISTRATION Clinicaltrials.gov NCT: 02884310; http://ift.tt/2B2PCiQ. Correspondence to Aline Defresne, MD, Department of Anaesthesia and Intensive Care Medicine, CHR Citadelle, Bd du 12eme de Ligne, 1, 4000 Liege, Belgium E-mail: adefresne@chu.ulg.ac.be © 2017 European Society of Anaesthesiology
http://ift.tt/2z0fN8n
http://ift.tt/2z0fN8n
Standardised noxious stimulation-guided individual adjustment of remifentanil target-controlled infusion to prevent haemodynamic responses to laryngoscopy and surgical incision: A randomised controlled trial
BACKGROUND The surgical plethysmographic index (SPI) is one of the available indexes of the nociception–antinociception (NAN) balance. Individually adjusting the NAN balance to prevent somatic responses to noxious stimulation remains a challenge. OBJECTIVES To assess whether guiding remifentanil administration according to the SPI response to a calibrated noxious stimulus (NANCAL) can blunt the haemodynamic response to tracheal intubation and surgical incision. DESIGN Prospective randomised multicentre controlled study. SETTING Two Belgian university hospitals from January 2014 to April 2015. PATIENTS After ethic review board approval and informed consent, 48 American Society of Anesthesiologists I or II adult patients scheduled for surgery under general anaesthesia were enrolled. INTERVENTIONS Patients were randomly assigned to a SPI group, where remifentanil effect-site concentration was adjusted according to NANCAL, or a control group, where it was fixed at 4 ng ml−1. Propofol concentration was always adjusted to maintain the bispectral index close to 40. NANCAL consisted of a 100 Hz, 60 mA electrical tetanic stimulation during 30 s at the wrist before tracheal intubation and before surgical incision. MAIN OUTCOME MEASURES The primary endpoint was the efficacy of the NANCAL-guided remifentanil administration to prevent the haemodynamic response to tracheal intubation and surgical incision. The secondary aim was to compare the ability of SPI, analgesia nociception index, pupil diameter and mean arterial pressure response to NANCAL to predict the haemodynamic response to tracheal intubation and surgical incision. RESULTS Our SPI response to NANCAL-based correcting scheme for remifentanil administration was not superior to a fixed remifentanil concentration at blunting the haemodynamic response to tracheal intubation or surgical incision. Among all tested NAN balance indices, only mean arterial pressure had significant predictive ability with regard to the haemodynamic response to surgical incision. CONCLUSION Further research is needed to define the best NANCAL stimulus and the best remifentanil correcting scheme to help individualised tailoring of antinociception for each specific subpopulation of surgical patients. TRIAL REGISTRATION Clinicaltrials.gov NCT: 02884310; http://ift.tt/2B2PCiQ. Correspondence to Aline Defresne, MD, Department of Anaesthesia and Intensive Care Medicine, CHR Citadelle, Bd du 12eme de Ligne, 1, 4000 Liege, Belgium E-mail: adefresne@chu.ulg.ac.be © 2017 European Society of Anaesthesiology
http://ift.tt/2z0fN8n
http://ift.tt/2z0fN8n
EACPT News
Publication date: October 2017
Source:Clinical Therapeutics, Volume 39, Issue 10
http://ift.tt/2jH8GyZ
Factors Associated with Type 2 Diabetes Mellitus Treatment Choice Across Four European Countries
Publication date: Available online 4 November 2017
Source:Clinical Therapeutics
Author(s): Edith M. Heintjes, Jetty A. Overbeek, Gillian C. Hall, Daniel Prieto-Alhambra, Francesco Lapi, Niklas Hammar, Irene D. Bezemer
PurposeThe aim of this analysis was to identify factors associated with the choice of type 2 diabetes mellitus (T2DM) therapy at the time of intensification of antidiabetic treatment across 4 European countries.MethodsAntidiabetic drug prescription/dispensing records and patients' characteristics were obtained from the electronic health care records of patients with T2DM from the Netherlands (NL), Italy, and Spain (ES) (all, 2007–2011); and the United Kingdom (UK; 2008–2012). Oral monotherapy was defined as first-line; oral dual therapy, as second-line; >2 oral treatments or oral combined with an injectable, as third-line; and injectables only, as fourth-line treatment. Treatment intensification was defined as the start of a higher line of treatment. Comedication, comorbidities, clinical parameters, and other factors associated with treatment choice were identified using multivariate relative risk estimation by Poisson regression with robust error variance.FindingsIn the 5-year study period, 485,120 patients (79% of the treated T2DM population) underwent treatment intensification. Changes in treatment choice were clearly visible over the study period, such as a decline in the use of thiazolidinediones (NL, ES, UK) and increases in the use of dipeptidyl peptidase-4 inhibitors (DPP4i) (NL, ES, UK) and glucagon-like peptide-1 receptor agonists (UK). With first-line treatment, advanced age and renal comorbidity were associated with the use of sulfonylureas (SUs; all countries), whereas high body mass index (BMI) was inversely associated with SU use in the United Kingdom and Spain. With second-line treatment, advanced age was associated with metformin + SU use (all countries); and renal comorbidity with SU + DPP4i use in the United Kingdom and the Netherlands. High BMI was associated with metformin + thiazolidinedione (TZD) use in the United Kingdom and Spain, and with metformin + DPP4i in the United Kingdom. With third-line treatment, advanced age and renal comorbidity were associated with the use of SU + insulin (NL, ES, UK). Hemoglobin A1c >8.5% was positively associated, and high BMI was inversely associated, with the use of any third-line combination containing insulin. Across treatment lines TZD and metformin were negatively associated with renal and cardiac morbidity. Second and third line treatment choices strongly depended on prior treatments. With fourth-line treatment, women were more likely to receive glucagon-like peptide-1 receptor agonists than were men in the United Kingdom and Spain.ImplicationsThe results suggest that the main factors driving treatment choice at any stage of intensification were age, hemoglobin A1c, BMI, renal and cardiac morbidity, and treatment history. These drivers were consistent with guidelines on, and contraindications of, specific medications. Differences between countries were generally consistent with, but not solely attributable to, differences in local guidelines and reimbursement policies.
http://ift.tt/2hMVx6U
Publication date: Available online 3 November 2017 Source:Clinical Therapeutics Author(s): Laura...
Source:Clinical Therapeutics
Author(s): Laura S. Madore, Sarbattama Sen
http://ift.tt/2jFjM7w
Erratum to 'Clinical Therapeutics Supplement: The Proceedings of the 13th Congress of the European Association for Clinical Pharmacology and Therapeutics' Clin Ther. 2017;39:e1-e110
Publication date: Available online 3 November 2017
Source:Clinical Therapeutics
http://ift.tt/2hO9oJX
Canagliflozin in Conjunction With Sulfonylurea Maintains Glycemic Control and Weight Loss Over 52 Weeks: A Randomized, Controlled Trial in Patients With Type 2 Diabetes Mellitus
Publication date: Available online 3 November 2017
Source:Clinical Therapeutics
Author(s): Jean-François Yale, John Xie, Stephen E. Sherman, Claude Garceau
PurposeOur aim was to investigate the long-term efficacy and safety of canagliflozin, a sodium−glucose co-transporter 2 inhibitor, added to background sulfonylurea (SU) monotherapy for patients with type 2 diabetes mellitus.MethodsThe CANagliflozin cardioVascularAssessment Study (CANVAS) was a double-blind, placebo-controlled cardiovascular outcomes study that randomly assigned participants to receive placebo or canagliflozin 100 or 300 mg once daily in addition to routine therapy. CANVAS included a prespecified SU substudy of patients taking background doses of SU monotherapy; data from the primary efficacy evaluation at 18 weeks have been published previously. We performed a retrospective analysis of the SU substudy at 52 weeks to measure long-term efficacy and safety of canagliflozin used with an SU. The primary objective of the long-term extension was to assess the change from baseline to 52 weeks in glycosylated hemoglobin (HbA1c).FindingsA total of 215 patients were included in the 52-week extension study. Patients receiving both 100-mg and 300-mg doses of canagliflozin achieved a sustained reduction in HbA1c relative to patients receiving placebo (−0.61% [95% CI, −0.941% to −0.282%] and −0.66% [95% CI, −0.993% to −0.332%], respectively), regardless of baseline HbA1c, duration of diabetes, SU dose, estimated glomerular filtration rate, or body mass index. A sustained reduction in fasting plasma glucose was also found in both 100-mg and 300-mg groups, relative to the placebo group (−2.04 mmol/L [95% CI, −2.778 to −1.299 mmol/L] and −1.88 mmol/L [95% CI, −2.623 to −1.146 mmol/L], respectively). Weight was reduced significantly at 52 weeks in both 100-mg and 300-mg groups, relative to placebo (−1.9% [95% CI, −3.2% to −0.7%] and −2.0% [95% CI, −3.2% to –0.7%], respectively). Reduction in systolic blood pressure was also reported for both dose groups relative to the placebo group, but there was no clear difference in HDL-C, LDL-C, or triglyceride levels. Canagliflozin was generally well tolerated. While documented hypoglycemia occurred in 14% of patients on placebo, the frequency of hypoglycemia with the addition of canagliflozin was similar. There was an increased frequency of genital mycotic infections in both men (5.1%) and women (10.4%) in both canagliflozin groups combined, relative to the placebo group (0%), and their frequency increased in the higher-dose group. There was a slightly higher rate of renal impairment in those treated with canagliflozin versus placebo (2.1% vs 0%).ImplicationsAfter 52 weeks, patients receiving canagliflozin added to background SU had sustained reductions in HbA1c and fasting plasma glucose, without increasing hypoglycemia and body weight; safety findings were generally consistent with the known safety profile of the drug. ClinicalTrials.gov identifier: NCT01032629.
http://ift.tt/2jGClIp
Lipid Management After First Diagnosis of Coronary Artery Disease: Contemporary Results From an Observational Cohort Study
Source:Clinical Therapeutics
Author(s): Christoph Waldeyer, Moritz Seiffert, Nils Staebe, Julian Braetz, Rebecca Kohsiack, Francisco Ojeda, Niklas Schofer, Mahir Karakas, Tanja Zeller, Christoph Sinning, Benedikt Schrage, Dirk Westermann, Karsten Sydow, Stefan Blankenberg, Fabian J. Brunner, Renate B. Schnabel
PurposeAlthough the efficacy of lipid-lowering medication (LLM) in patients with coronary artery disease (CAD) is well established, the majority of patients fail to achieve their LDL-C goals. The evidence for measurement of LDL-C to achieve these goals is limited. The goal of the present study, therefore, was to analyze ambulatory LLM management in relation to performance of LDL-C measurements and achieved LDL-C levels after the initial diagnosis of CAD.MethodsThe study followed up a subcohort of 200 patients with newly diagnosed CAD of the INTERCATH trial, an observational study including patients undergoing coronary angiography. In addition to baseline information, data were collected on LLM, performance of lipid measurements, and laboratory results at a minimum of 6 months' postdischarge.FindingsThe mean age of the sample was 67.9 years, and 36.0% were women. In 34.5% of all patients, no measurement of LDL-C levels was performed during follow-up. We found no differences in baseline characteristics between patients with and without LDL-C measurements during follow-up. In patients with measurement of LDL-C levels, the frequency of intensification of statin medication according to LDL-C reduction was higher compared with those patients without LDL-C measurement (23.6% vs 4.3%; P < 0.001); all other categories of intensity adjustment were comparable. In patients with 3 LDL-C measurements, achieved LDL-C levels were significantly lower (mean, 81 mg/dL), and a higher proportion reached an LDL-C level <70 mg/dL (44.7%) compared with patients with 1 (95 mg/dL [P = 0.013]; 21.8%) or 2 (91 mg/dL [P = 0.037]; 28.9%) LDL-C measurements despite comparable LDL-C levels at baseline. Ezetimibe was used in 3.5% of the entire study cohort.ImplicationsWe found no differences in patient characteristics between patients with and without LDL-C measurements after being newly diagnosed with CAD. Performance and frequency of LDL-C measurements were clearly associated with better, higher frequency of intensification of statin medication, lower achieved LDL-C levels, and a higher proportion of patients achieving the LDL-C goal of <70 mg/dL. These results suggest an important role of LDL-C measurements for secondary prevention after the initial diagnosis of CAD.
http://ift.tt/2hMVsjC
A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and the Tolerability of a Triple Combination of Amlodipine/Losartan/Rosuvastatin in Patients With Comorbid Essential Hypertension and Hyperlipidemia
Source:Clinical Therapeutics
Author(s): Hae-Young Lee, Seok-Yeon Kim, Kee-Joon Choi, Byung-Su Yoo, Dong-Hun Cha, Hae Ok Jung, Dong-Ryeol Ryu, Joon Hyouk Choi, Kwang Je Lee, Tae Ho Park, Ju Hyeon Oh, Sang Min Kim, Ji-Yong Choi, Kye Hun Kim, Jaemin Shim, Woo-Shik Kim, Si-Wan Choi, Dae-Gyun Park, Pil-Sang Song, Taek-Jong Hong, Moo-Yong Rhee, Seung-Woon Rha, Seung Woo Park
PurposeThe objective of this study was to evaluate the efficacy and tolerability of a triple combination of amlodipine/losartan/rosuvastatin in patients with hypertension and hypercholesterolemia.MethodsA randomized, multicenter, double-blind, placebo-controlled study was conducted. Eligible patients with hypertension and a sitting diastolic blood pressure (SiDBP) of >90 mm Hg and LDL-C levels <250mg/dL were screened. After a 4-week run-in period with therapeutic lifestyle changes and losartan potassium 100mg once daily, patients who met both blood pressure criteria (80 mm Hg ≤ SiDBP < 110 mm Hg) and the LDL-C level criteria (defined in the National Cholesterol Education Program Adult Treatment Panel III cardiovascular risk categories) were randomized to 1 of 3 groups and treated once daily for 8 weeks: losartan potassium 100mg + rosuvastatin 20mg treatment (L/R 100/20) group, amlodipine camsylate 5mg + losartan potassium 100mg treatment (A/L 5/100) group, and amlodipine 5mg+ losartan potassium 100mg + rosuvastatin 20mg (A/L/R 5/100/20) group. The primary efficacy variables were the percent change in LDL-C in the A/L/R 5/100/20 and A/L 5/100 groups and the mean change of SiDBP in the A/L/R 5/100/20 and L/R 100/20 groups after 8 weeks of treatment, relative to baseline values.FindingsA total of 146 patients were enrolled and the demographic characteristics were similar among the 3 treatment groups. After 8 weeks of treatment, the mean (SD) percent change in LDL-C was significantly greater in the A/L/R group than in the A/L group (–48.40% [2.77%] vs –6.70% [3.00%]; P < 0.0001). Moreover, the mean change in SiDBP was significantly greater in the A/L/R group than in the L/R group (–9.75 [0.92] mm Hg vs –1.73 [1.03] mm Hg; P < 0.0001). SiDBP and LDL-C reductions in the A/L/R group were comparable to reductions in the A/L and L/R groups, respectively. Ten adverse events were reported in 7 patients (4.83%), and 1 patient from the A/L group (0.69%) experienced 2 adverse drug reactions (tachycardia and face edema), which were mild and resolved without specific treatment. There were no clinically significant tolerability issues during the treatment period.ImplicationsTriple combination therapy with amlodipine/losartan/rosuvastatin can be an effective therapeutic strategy in patients with hypertension combined with dyslipidemia. These findings will form the foundation of the future development of a single-pill triple combination. ClinicalTrials.gov identifier: NCT02899455.
http://ift.tt/2jFr1fE
Neonatal Weight Gain on Minute or Large Amounts of Donor Milk
Source:Clinical Therapeutics
Author(s): Sergio Verd, Gemma Ginovart
http://ift.tt/2jH8EXT
Long-term Clinical and Cost Outcomes of a Pharmacist-managed Risk Factor Management Clinic in Singapore: An Observational Study
Source:Clinical Therapeutics
Author(s): She Hui Tan, Kwee Keng Kng, Sze Mian Lim, Alexandre Chan, Jason Kwok Kong Loh, Joyce Yu-Chia Lee
PurposeFew studies have determined the benefits of pharmacist-run clinics within a tertiary institution, and specifically on their capability to improve clinical outcomes as well as reduce the cost of illness. This study was designed to investigate the effectiveness of a pharmacist-managed risk factor management clinic (RFMP) in an acute care setting through the comparison of clinical (improvement in glycosylated hemoglobin level) and cost outcomes with patients receiving usual care.MethodsThis single-center, observational study included patients aged ≥21 years old and diagnosed with type 2 diabetes mellitus (DM) who received care within the cardiology department of a tertiary institution between January 1, 2014, and December 31, 2015. The intervention group comprised patients who attended the RFMP for 3 to 6 months, and the usual-care group comprised patients who received standard cardiologist care. Univariate analysis and multiple linear regression were conducted to analyze the clinical and cost outcomes.FindingsA total of 142 patients with DM (71 patients in the intervention group and 71 patients in the usual-care group) with similar baseline characteristics were included. After adjusting for differences in baseline systolic blood pressure and triglyceride levels, the mean reduction in glycosylated hemoglobin level at 6 months from baseline in the intervention group was significantly lower by 0.78% compared with the usual-care group. Patients in the usual-care group had a significantly higher risk of hospital admissions within the 12 months from baseline compared with the intervention group (odds ratio, 3.84 [95% CI, 1.17–12.57]; P = 0.026). Significantly lower mean annual direct medical costs were also observed in the intervention group (US $8667.03 [$17,416.20] vs US $56,665.02 [$127,250.10]; P = 0.001).ImplicationsThe pharmacist-managed RFMP exhibited improved clinical outcomes and reduced health care costs compared with usual care within a tertiary institute.
http://ift.tt/2hMVrw4
Musings on Social Media and GIST (Gastrointestinal Stromal Cancer)
Source:Clinical Therapeutics
Author(s): Richard J. Shader
http://ift.tt/2jH8Git
“I’m Home(screen)!”: Social Media in Health Care Has Arrived
Source:Clinical Therapeutics
Author(s): Laura T. Housman
In more than a decade, the adoption and use of some type of social media among American adults has risen from 5% in 2005 to nearly 70% in 2016. The reigning social media platform by usage, Facebook, has 142% more American adult users than the second most utilized social media platform, Instagram, which was purchased by Facebook in March 2012. Of the 68% of American adult Facebook users, more than three quarters visit the site daily. Although social media applications (apps) such as Facebook and Instagram are the clear draw among users, health care apps are beginning to gain traction as well. In 2017, 32% of consumers now have at least 1 health app on their smartphones or tablets, doubling over the past 4 years. Although having an app should not be confused with using an app, having an app downloaded and available for use is a step closer to ongoing adoption. Mobile apps in health care are being used for ordering and scheduling health care services, as well as tracking and managing aspects of health and wellness. An incredible opportunity now exists to connect and leverage social media to enhance the impact of health care, particularly in the areas of drug development, clinical trial recruitment, and therapy administration and adherence, in which dose reminders, sharing of side effects and response, and the accessibility of patients to one another has both a context and a platform. This commentary serves as an introduction to the ways that social media and mobile health care apps are being used in real-world settings as tools to advance the development and effectiveness of clinical therapeutics.
http://ift.tt/2hMVpnW
#PatientVoiceMatters: How Social Media Is Bringing Patients and Biopharmaceutical Companies Together to Improve Drug Development
Source:Clinical Therapeutics
Author(s): Stella Stergiopoulos
http://ift.tt/2jHeIzl
Improving Patient Involvement in the Drug Development Process: Case Study of Potential Applications from an Online Peer Support Network
Source:Clinical Therapeutics
Author(s): Amrutha Anand, Helen Jane Brandwood, Matt Jameson Evans
To date, social media has been used predominantly by the pharmaceutical industry to market products and to gather feedback and comments on products from consumers, a process termed social listening. However, social media has only been used cautiously in the drug development cycle, mainly because of regulations, restrictions on engagement with patients, or a lack of guidelines for social media use from regulatory bodies. Despite this cautious approach, there is a clear drive, from both the industry and consumers, for increased patient participation in various stages of the drug development process. The authors use the example of HealthUnlocked, one of the world's largest health networks, to illustrate the potential applications of online health communities as a means of increasing patient involvement at various stages of the drug development process. Having identified the willingness of the user population to be involved in research, numerous ways to engage users on the platform have been identified and explored. This commentary describes some of these approaches and reports how online health networks that encourage people to share their experiences in managing their health can, in turn, enable rapid patient engagement for clinical research within the constraints of industry regulation.
http://ift.tt/2hMW3So
Patient-Reported Outcomes in Patients with Type 2 Diabetes Treated with Dulaglutide Added to Titrated Insulin Glargine (AWARD-9)
Source:Clinical Therapeutics
Author(s): Maria Yu, Kate Van Brunt, Zvonko Milicevic, Oralee Varnado, Kristina S. Boye
PurposeThis 28-week, randomized, double-blind study compared a once-weekly injection of dulaglutide 1.5 mg to placebo, both added to titrated once-daily insulin glargine (with or without metformin), in patients with type 2 diabetes mellitus and inadequate glycemia control (control defined as hemoglobin A1c, ≥7% and ≤10.5%). Patient-reported outcomes were assessed as an exploratory objective to further understand patients' physical, psychological, and social aspects of well-being and injection-device experience.MethodsPatients not naive to injectable therapy were randomly assigned (1:1) to receive dulaglutide/glargine or placebo/glargine; glargine was titrated to a fasting plasma glucose target of 71 to 99 mg/dL. The Impact of Weight on Self-Perceptions (IW-SP), the EQ-5D-5L (measure of health status), the 18-item Diabetes Health Profile (DHP-18), and the Medication Device Delivery Assessment (MDDAB) instruments for assessing the dulaglutide Single-Use Pen (SUP) and glargine-delivery device were administered at baseline and 28 weeks, and also at 6 or 12 weeks for some measures. A mixed model for repeated measures was used for analyzing changes from baseline scores.FindingsAt 28 weeks, improvements observed in the transformed total scores on the IW-SP and DHP-18 Disinhibited Eating domain were significantly greater with dulaglutide/glargine compared with placebo/glargine (least squares mean differences, +6.06 [P = 0.019] and –4.50 [P = 0.017], respectively). There were no significant overall between-treatment differences in quality of life as measured by the EQ-5D-5L or the Barriers to Activities and Psychological Distress domains of the DHP-18. Of all patients, 95% reported that overall, the dulaglutide SUP was "easy" or "very easy" to use at 28 weeks. Device-features scores showed that most patients liked the dulaglutide SUP features, with the 3 highest-rated items relating specifically to features of the needle (not having to touch the needle, not having to attach the needle, and automatic insertion). The majority of patients (~90%) "agreed" or "strongly agreed" that they were satisfied with the overall dulaglutide SUP injection experience at 28 weeks.ImplicationsDulaglutide/glargine-treated patients had greater improvements in weight-related quality-of-life measures compared with placebo/glargine-treated patients, which may be clinically relevant when evaluating treatment options for insulin-requiring patients who often gain weight with insulin monotherapy. Results from the MDDAB indicated overall satisfaction with the dulaglutide SUP injection experience, which may be an important factor in some patients when initiating parenteral therapy. ClinicalTrials.gov identifier: NCT02152371.
http://ift.tt/2jF6lUU
Management of Allergic Rhinitis: A Review for the Community Pharmacist
Source:Clinical Therapeutics
Author(s): J. Russell May, William K. Dolen
PurposeAllergic rhinitis is a highly prevalent disease affecting the quality of life of millions of North Americans. The management of allergic rhinitis includes allergen avoidance, pharmacotherapy, and immunotherapy. Current pharmacologic options include oral and intranasal antihistamines, intranasal corticosteroids, oral and intranasal decongestants, oral and intranasal anticholinergics, and leukotriene receptor antagonists. Second-generation oral antihistamines and intranasal corticosteroids are the mainstays of treatment, with practice guidelines recommending intranasal corticosteroids as first-line treatment for moderate to severe allergic rhinitis.MethodsClinical trials studying a widely used intranasal corticosteroid, fluticasone propionate, in comparison with second-generation oral antihistamines, cetirizine, loratadine, or montelukast, were selected to support the comparative review of the efficacy and tolerability of these 2 classes of medications. Studies evaluating the combination of fluticasone propionate with an oral antihistamine were also included to review the efficacy and tolerability of combination therapy to treat allergic rhinitis.FindingsStudies comparing fluticasone propionate with cetirizine had mixed findings; fluticasone propionate was found to have equal or greater efficacy in reducing nasal symptom scores. Combination therapy of fluticasone propionate and the oral antihistamine, loratadine, was found to have efficacy comparable with that of intranasal corticosteroid alone.ImplicationsMany of these medications are available over the counter in the pharmacy, and the community pharmacist plays an important role as part of the patient's health care team in managing this disease. Pharmacotherapy is patient-specific, based on type, duration, and severity of symptoms, comorbidities, prior treatment, and patient preference. This article aims to provide an overview of the pathophysiology, available treatment options, guideline recommendations, and role of the pharmacist for this disease.
http://ift.tt/2hMVkAE
Moving Beyond Conventional Clinical Trial End Points in Treatment-Refractory Metastatic Colorectal Cancer: A Composite Quality-of-Life and Symptom Control End Point
Source:Clinical Therapeutics
Author(s): Jun Gong, Daniel Wu, Jeremy Chuang, Richard Tuli, John Simard, Andrew Hendifar
PurposeThis review highlights the evidence supporting symptom control and quality-of-life (QOL) measures as predictors of survival in treatment-refractory metastatic colorectal cancer (mCRC) and describes a composite symptom control and QOL end point recently reported in a Phase III trial that may serve as a more reasonable end point of efficacy in this population.MethodsA literature search was conducted using MEDLINE to identify clinical studies (including case series and observational, retrospective, and prospective studies) that reported the predictive value of QOL measures for survival in mCRC. The search was limited by the following key words: quality of life, survival, and colorectal cancer. We then performed a second search limited to studies of randomized and Phase III design in mCRC to identify studies that used QOL assessments as their primary end points. A manual search was also performed to include additional studies of potential relevance.FindingsThere is increasing evidence to support that symptom control and QOL measures are predictors of survival in treatment-refractory mCRC and can serve as an alternative but equally as important end point to survival in this population. A recent large, randomized Phase III trial using a composite primary end point of lean body mass, pain, anorexia, and fatigue reported the feasibility in evaluating benefit in mCRC beyond conventional clinical trial end points.ImplicationsFuture studies in treatment-refractory mCRC may be better served by evaluating improvement in symptom control and QOL, which may otherwise serve as the best predictor of survival in last-line treatment settings.
http://ift.tt/2jH8G1X
Examining and Enabling the Role of Health Care Providers as Patient Engagement Facilitators in Clinical Trials
Source:Clinical Therapeutics
Author(s): Kenneth A. Getz
PurposeThe Tufts Center for the Study of Drug Development conducted a study among practicing physicians and nurses (health care providers) across multiple specialties to assess their attitudes and experiences with referring patients into clinical trials and to supplement the body of scholarly research focused primarily on referral practices among oncology-based health care providers.MethodsA total of 755 physicians and 1255 nurses completed online surveys in late 2015 and early 2016.FindingsThe results of the study indicate that a high percentage of multispecialty nurses and physicians is interested in referring their patients to appropriate clinical trials, are familiar with the clinical trial process, and are comfortable providing clinical trial information to, and discussing clinical trial opportunities with, their patients. Study results also indicate, however, that health care providers refer only a small number of patients each year largely because of the inability to access clinical trial information and the lack of sufficient information and time to evaluate and confidently discuss clinical trial options with their patients.ImplicationsMany reasons for choosing not to refer patients appear addressable, particularly through effective but presently –underused communication leveraging social media communities and using liaisons who can act as a bridge between clinical care and clinical research.
http://ift.tt/2hMVhVu
Understanding the Patient Experience with Carcinoid Syndrome: Exit Interviews from a Randomized, Placebo-Controlled Study of Telotristat Ethyl
Source:Clinical Therapeutics
Author(s): Lowell Anthony, Claire Ervin, Pablo Lapuerta, Matthew H. Kulke, Pamela Kunz, Emily Bergsland, Dieter Hörsch, David C. Metz, Janice Pasieka, Nick Pavlakis, Marianne Pavel, Martyn Caplin, Kjell Öberg, John Ramage, Emily Evans, Qi Melissa Yang, Shanna Jackson, Karie Arnold, Linda Law, Dana B. DiBenedetti
PurposeTelotristat ethyl, an oral tryptophan hydroxylase inhibitor, is intended to treat carcinoid syndrome by reducing serotonin production. Telotristat ethyl was evaluated in TELESTAR, a Phase III study for patients who had carcinoid syndrome with at least 4 bowel movements (BMs) per day and who were receiving somatostatin analogue therapy. This interview substudy was conducted to provide insight into the patient experience in TELESTAR and to help understand whether reductions in BM frequency (the primary end point) and other symptoms were clinically meaningful.MethodsParticipating sites were asked to invite (before randomization) all eligible patients to telephone interviews scheduled at the end of the double-blind treatment period. Patients and interviewers were blinded to treatment.FindingsAll 35 interviewed participants reported diarrhea and/or excessive BMs at baseline. Patients reported that these symptoms negatively affected emotional, social, physical, and occupational well-being. Prespecified criteria for treatment response (achieving ≥30% reduction in BM frequency for at least 50% of the days) were met by 8 of 26 patients taking telotristat ethyl and 1 of 9 patients taking placebo. All 8 patients taking telotristat ethyl described clinically meaningful reductions in BM frequency and were very satisfied with the ability of the study drug to control their carcinoid syndrome symptoms. Overall, reports of being very satisfied were observed in 12 patients taking telotristat ethyl and 0 taking placebo.ImplicationsPatient interviews revealed that TELESTAR patients, at baseline, were significantly affected by their high BM frequency. Patient reports of their clinical trial experience supported the significance of the primary end point and clinical responder analysis in TELESTAR, helping identify and understand clinically meaningful change produced by telotristat ethyl.
http://ift.tt/2jFLaCc
Long-Term Systemic Corticosteroid Exposure: A Systematic Literature Review
Publication date: Available online 19 October 2017
Source:Clinical Therapeutics
Author(s): J. Bradford Rice, Alan G. White, Lauren M. Scarpati, George Wan, Winnie W. Nelson
PurposeWhile corticosteroids are relatively inexpensive and commonly used as treatment for a variety of conditions, long-term use is known to be associated with certain toxicities. Prior systematic reviews have revealed an increased risk for costly adverse events (AEs), including bone fracture, infection, and gastrointestinal bleeding. The objective of this study was to conduct a systematic literature review of recent publications on the burden of long-term corticosteroid exposure, specifically, to summarize the AEs and economic impact of long-term corticosteroid use and to reveal data gaps for additional research.MethodsThe Ovid search platform was used to access scientific literature databases. The search strategy targeted the use of corticosteroids and economic outcomes research. Articles were restricted to those published between 2007 and 2016 to cover publications since prior reviews; conference abstracts and articles assessing pediatrics were excluded. Titles and abstracts resulting from inclusion criteria were screened, and reviewers independently extracted relevant information from the relevant full-text articles.FindingsThe literature review included 32 articles, with 75% focusing on autoimmune diseases, asthma, or lung diseases. Included articles were 14 database analyses, 6 simulations, 6 clinical trials, 3 systematic literature reviews, 2 patient surveys, and 1 chart review. Commonly-cited AEs associated with long-term corticosteroid exposure included hypertension (prevalence >30%); bone fracture (21%–30%); cataract (1%–3%); nausea, vomiting, and other gastrointestinal conditions (1%–5%); and metabolic issues (eg, weight gain, hyperglycemia, and type 2 diabetes; cases had 4-fold the risk of controls). Association of dose and duration with increased AE risk is not well-quantified. AEs like peptic ulcer and myocardial infarction are particularly costly to payers (1-year cost of $21,825 and $26,472, respectively, in year-2009 USD). The few articles assessing the economic impact of corticosteroid use have found dose-related increases in health care resource utilization and costs, with per-annum incremental costs relative to nonusers ranging from $5700 in low-dose users (<7.5 mg/d) to $29,000 in high-dose users (>15 mg/d). Adherence to treatment guidelines on avoiding AEs (eg, prescribing of oral bisphosphonates, calcium, and vitamin D) remains low.ImplicationsAlthough doses of long-term corticosteroids have fallen over the past several decades in response to AEs, dose reduction may not be a sufficient solution. Numerous AEs, some very costly, persist among long-term corticosteroid users, suggesting a need for further research to fill current data gaps, as well as a potential need for alternative treatment options.
http://ift.tt/2hMVYy4
Differences in Adverse Event Reporting Rates of Therapeutic Failure Between Two Once-daily Extended-release Methylphenidate Medications in Canada: Analysis of Spontaneous Adverse Event Reporting Databases
Source:Clinical Therapeutics, Volume 39, Issue 10
Author(s): Laura Park-Wyllie, Judy van Stralen, Genaro Castillon, Stephen E. Sherman, Doron Almagor
PurposeOur study evaluated adverse events of therapeutic failure (and specifically reduced duration of action) with the use of a branded product, Osmotic Release Oral System (OROS) methylphenidate, which is approved for the treatment of attention deficit/hyperactivity disorder, and a generic product (methylphenidate, methylphenidate ER-C), which was approved for marketing in Canada based on bioequivalence to OROS methylphenidate. This study was initiated following reports that some US-marketed generic methylphenidate ER products had substantially higher reporting rates of therapeutic failure than did the referenced brands.MethodsThrough methodology similar to that used by the US Food and Drug Administration to investigate the issue with the US-marketed generic, reporting rates were calculated from cases of therapeutic failure identified in the Canadian Vigilance Adverse Reaction Online database for a 1-year period beginning 8 months after each product launch. Corresponding population exposure was estimated from the number of tablets dispensed. An in-depth analysis of narratives of individual case safety reports (ICSRs) with the use of the generic product was conducted in duplicate by 2 physicians to assess causality and to characterize the potential safety risk and clinical pattern of therapeutic failure. Similar secondary analyses were conducted on the US-marketed products.FindingsReporting rates of therapeutic failure with the use of methylphenidate ER-C (generic) and OROS methylphenidate (brand name) were 411.5 and 37.5 cases per 100,000 patient-years, respectively (reporting rate ratio, 10.99; 95% CI, 5.93–22.21). In-depth analysis of narratives of 230 ICSRs of therapeutic failure with the Canadian-marketed generic determined that all ICSRs were either probably (60 [26%]) or possibly (170 [74%]) causally related to methylphenidate ER-C. Clinical symptoms suggestive of overdose were present in 31 reports of loss of efficacy (13.5%) and occurred primarily in the morning, and premature loss of efficacy (shorter duration of action) was described in 98 cases (42.6%) and occurred primarily in the afternoon. Impacts on social functioning, such as disruption in work or school performance or adverse social behaviors, were found in 51 cases (22.2%).ImplicationsThe ~10-fold higher reporting rate of therapeutic failure with the generic product relative to its reference product in the present Canadian study resembles findings with US-marketed generic products. While these results should be interpreted with caution due to the limitations of spontaneous adverse event reporting, which may confound comparisons across products, similar findings nonetheless led the US Food and Drug Administration to declare in 2014 that 2 methylphenidate ER generic products in the United States were neither bioequivalent nor interchangeable with OROS methylphenidate—their reference product. Our results indicate a potential safety issue with the Canadian-marketed generic and suggest a need for further investigation by Health Canada.
http://ift.tt/2jIjInH
End-of-treatment positron emission tomography after uniform first-line therapy of B cell posttransplant lymphoproliferative disorder identifies patients at low risk of relapse in the prospective German PTLD registry
Background Fluorine-18 fluorodeoxyglucose (18F-FDG) - positron-emission tomography (PET) is a recommended standard in the staging and response assessment of 18F-FDG-avid lymphoma. Posttransplant lymphoproliferative disorder (PTLD) can be detected by 18F-FDG-PET at diagnosis with high sensitivity and specificity. However, the role of response assessment by end of treatment (EOT)-PET has only been addressed in small case series. Methods We performed a retrospective, multi-center study of 37 patients with CD20-positive posttransplant lymphoproliferative disorder (PTLD) after solid organ transplantation (SOT) treated with uniform, up-to-date first-line protocols in the prospective German PTLD registry who had received EOT-18F-FDG-PET between 2006 and 2014. Median follow-up was 5.0 years. Any nonphysiological 18F-FDG uptake (Deauville score greater 2) was interpreted as PET-positive. Results By computed tomography (CT) final staging, 18 out of 37 patients had a complete response (CR), 18 had a partial response and 1 patient had stable disease. EOT PET was negative in 24/37 patients and positive in 13/37. The positive predictive value of EOT PET for PTLD relapse was 38% and the negative predictive value 92%. Time to progression (TTP) and progression-free-survival (PFS) were significantly longer in the PET negative group (p=0.019 and p=0.013). In the 18 patients in a partial response by CT staging, we noted highly significant differences in overall survival (p=0.001), TTP (p=0.007), and PFS (p
http://ift.tt/2B4zjlt
http://ift.tt/2B4zjlt
Lung transplantation as a therapeutic option in acute respiratory distress syndrome
Background Lung transplantation (LTPL) is considered as a salvage therapeutic option in patients with end-stage lung disease. However, there is a lack of sufficient data on the use of LTPL in patients with acute respiratory distress syndrome (ARDS). While there are few case reports on lung transplant for ARDS, no case series exist up to date. The aim of this study was to evaluate the clinical outcomes of patients with ARDS in accordance with the LTPL status. Methods Patients who had severe ARDS (PaO2/FiO2 ratio ≤ 100 mmHg with positive end expiratory pressure ≥ 5 cmH2O) and were listed for LTPL with no underlying end-stage lung disease were included in this single-center retrospective study. Demographic and clinical data of the patients were collected and analyzed. Results Fourteen patients were listed for LTPL due to severe ARDS. All patients received mechanical ventilation, and 12 (86%) patients underwent extracorporeal membrane oxygenation. Of the nine patients who underwent LTPL, eight (89%) survived, whereas only one patient (20%) out of those who did not receive LTPL survived. The median survival time of the patients who underwent LTPL was 1996 days (interquartile range (IQR), 872–2239), compared with 49 days (IQR, 872–2239) in patients who did not undergo LTPL. The median survival time after LTPL was 64 months (IQR, 28–72). The three-year survival rate of the recipients was 78%. Conclusions LTPL may be considered as a therapeutic option in a select group of patients with severe ARDS. However, the irreversibility of the patient's lung status should be considered. Correspondence to: Seung-Il Park, M.D.: Department of Thoracic and Cardiovascular Surgery, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Korea, E-mail: sipark@amc.seoul.kr, Sang-Bum Hong, M.D.: Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Korea, E-mail:sbhong@amc.seoul.kr Seung-Il Park, M.D. and Sang-Bum Hong, M.D. equally contributed to this study. Contributions: Conception and design: SH, SP, TS; Acquisition, analysis and interpretation: YC, SL, SC, HK, YK, DK, KD, IC; Drafting the manuscript for important intellectual content: YC, SH, SP, TS. Conflicts of interest: The authors declare no conflicts of interest. Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved.
http://ift.tt/2yXUvIr
http://ift.tt/2yXUvIr
Incidence and Risk Factors of Intracranial Hemorrhage in Liver Transplant Recipients
Background Intracranial hemorrhage after liver transplantation is an infrequently reported complication but one which can have devastating consequences. Methods We performed a retrospective cross-sectional analysis of all liver transplants performed between January 2010 and June 2015 at a single high-volume institution using a prospectively maintained electronic database and query of the electronic medical record. Cases of intracranial hemorrhage were adjudicated as either spontaneous intraparenchymal (IPH) or extra-axial (EAH) hemorrhages. Patients with confirmed intracranial hemorrhage were compared with all other liver transplant recipients. Risk factors were identified by univariate analysis and logistic regression models for IPH and EAH. Results Thirty-one (5.2%) of 595 liver transplant recipients developed an intracranial hemorrhage within 12 months of transplantation, 15 IPH and 16 EAH. The majority of intracranial hemorrhages were diagnosed within 1 month of transplantation. Eight (26%) intracranial hemorrhage patients died during hospitalization. Fourteen (45%) intracranial hemorrhage patients died within 1 year of transplantation and 1-year mortality was greater than in patients without intracranial hemorrhage (11.2%, p
http://ift.tt/2B41fWT
http://ift.tt/2B41fWT
Lung Isolation in the Patient With a Difficult Airway
One-lung ventilation is routinely used to facilitate exposure for thoracic surgical procedures and can be achieved via several lung isolation techniques. The optimal method for lung isolation depends on a number of factors that include (1) the indication for lung isolation, (2) anatomic features of the upper and lower airway, (3) availability of equipment and devices, and (4) the anesthesiologist's proficiency and preferences. Though double-lumen endobronchial tubes (DLTs) are most commonly utilized to achieve lung isolation, the use of endobronchial blockers offer advantages in patients with challenging airway anatomy. Anesthesiologists should be familiar with existing alternatives to the DLT for lung isolation and alternative techniques for DLT placement in the patient with a difficult airway. Newer technologies such as videolaryngoscopy with or without adjunctive fiberoptic bronchoscopy may facilitate intubation and lung isolation in difficult airway management. Accepted for publication October 3, 2017. Funding: None. The authors declare no conflicts of interest. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's website (http://ift.tt/KegmMq). Reprints will not be available from the authors. Address correspondence to Randal S. Blank, MD, PhD, Department of Anesthesiology, Thoracic Anesthesia, University of Virginia Health System, PO Box 800710-0710, Charlottesville, VA 22908. Address e-mail to rsb8p@virginia.edu. © 2017 International Anesthesia Research Society
http://ift.tt/2AU7MCm
http://ift.tt/2AU7MCm
Ultrasound-Assisted Versus Fluoroscopic-Guided Lumbar Sympathetic Ganglion Block: A Prospective and Randomized Study
BACKGROUND: Fluoroscopy (FL)-guided lumbar sympathetic ganglion block (LSGB) is widely performed to diagnose and manage various diseases associated with sympathetically maintained pain. Recently, numerous ultrasound (US)-assisted procedures in pain medicine have been attempted, showing an advantage of low radiation exposure. This randomized, prospective trial compared the procedural outcomes and complications between FL-guided and US-assisted LSGBs. METHODS: Fifty LSGBs were randomly divided into 2 groups: FL-guided (FL group) or US-assisted (US group) LSGB group. Both groups received FL-guided or US-assisted LSGB with 10 mL of 0.25% levobupivacaine. The primary end point was the total procedure time. Secondary outcomes were success rate, imaging time, onset time (based on temperature rise), dosage of radiation exposure, other procedure-related outcomes, and complications. RESULTS: Total procedure time and success rate were not statistically different between the 2 groups, whereas imaging time of the US group was longer than that of the FL group (P = .012). The onset time was faster in the US group (P = .019), and bone touching during the procedure was less frequent in the US group (P = .001). Moreover, radiation exposure was significantly lower in the US group than in the FL group (P
http://ift.tt/2ixNA2r
http://ift.tt/2ixNA2r
Perioperative Noninvasive Blood Pressure Monitoring
The most commonly monitored variable for perioperative hemodynamic management is blood pressure. Several indirect noninvasive blood pressure monitoring techniques have been developed over the last century, including intermittent techniques such as auscultation (Riva-Rocci and Korotkoff) and oscillometry (Marey) and continuous techniques. With the introduction of automated noninvasive blood pressure devices in the 1970s, the oscillometric technique quickly became and remains the standard for automated, intermittent blood pressure measurement. It tends to estimate more extreme high and low blood pressures closer to normal than what invasive measurements indicate. The accuracy of the oscillometric maximum amplitude algorithm for estimating mean arterial pressure is affected by multiple factors, including the cuff size and shape, the shape of the arterial compliance curve and arterial pressure pulse, and pulse pressure itself. Additionally, the technique typically assumes a consistent arterial compliance and arterial pressure pulse, thus changes in arterial compliance and arrhythmias that lead to variation in the pressure pulse can affect accuracy. Volume clamping, based on the Penaz principle, and arterial tonometry provide continuous tracking of the arterial pressure pulse. The ubiquitous use of blood pressure monitoring is in contrast with the lack of evidence for optimal perioperative blood pressure targets. Accepted for publication September 27, 2017. Funding: None. The authors declare no conflicts of interest. Reprints will not be available from the authors. Address correspondence to Kai Kuck, PhD, Department of Anesthesiology, University of Utah Medical School, 30 N 1900 E Room 3c444, Salt Lake City, UT 84132. Address e-mail to kai.kuck@hsc.utah.edu. © 2017 International Anesthesia Research Society
http://ift.tt/2AUor8N
http://ift.tt/2AUor8N
Εγγραφή σε:
Αναρτήσεις (Atom)