Errol Gould - Academia.edu (original) (raw)

Papers by Errol Gould

Research paper thumbnail of Extended‐release naltrexone/bupropion and liver health: Pooled, post hoc analysis from four randomized controlled trials

Diabetes, Obesity and Metabolism

Research paper thumbnail of The Relationship of Changes in Pain Quality to Pain Interference and Sleep Quality

The Journal of Pain, 2010

Pain is a complex multidimensional experience that includes overall intensity/magnitude, unpleasa... more Pain is a complex multidimensional experience that includes overall intensity/magnitude, unpleasantness/bothersomeness (affect), location, and quality. However, there is a paucity of research examining the importance of pain quality to patient functioning; most research focuses only on the intensity and affective components of pain. This study sought to address this gap by examining, in a sample of patients with carpal tunnel syndrome (CTS), the associations between pain quality and 2 domains of patient functioning: pain interference and sleep quality. We found that measures of pain quality contributed to the prediction of pain interference and sleep quality over and above the effects of global pain intensity and unpleasantness. In our sample, both throbbing and itchy pain emerged as contributing the most unique variance to the prediction of patient functioning. The findings indicate that the presence of pain described as throbbing or itchy, regardless of the overall magnitude of pain, may make patients with CTS particularly vulnerable to the negative impact of pain on quality of life. The findings support the need for experimental studies to determine if treatments can be identified that address these 2 pain qualities, and if effective treatments for these qualities in particular result in significant improvement in the quality of life of patients with CTS. A growing body of research supports the importance of assessing multiple domains of pain in clinical and research settings. The current findings suggest the possibility that, in patients with carpal tunnel syndrome, itchy and throbbing pain may play key roles in patient functioning above and beyond global pain intensity and unpleasantness. More research is needed to confirm this finding, and whether treatments can be identified that address these pain qualities specifically.

Research paper thumbnail of The Dimensions of Pain Quality: Factor Analysis of the Pain Quality Assessment Scale

The Clinical Journal of Pain, 2008

To provide a better empirical understanding of the dimensionality of neuropathic and non-neuropat... more To provide a better empirical understanding of the dimensionality of neuropathic and non-neuropathic pain quality. An exploratory factor analysis (FA) was performed with baseline pain quality data [assessed using the Pain Quality Assessment Scale (PQAS)] from patients with osteoarthritis of the knee (n=368) and low back pain (n=455) who had participated in a series of analgesic clinical trials. The results of the FA were then confirmed in a sample of patients with neuropathic pain secondary to carpal tunnel syndrome (n=138). Comparisons between the diagnostic groups on scale scores derived from the FA results were also made using t tests. Three clear pain quality factors emerged that seemed to represent (1) paroxysmal pain sensations (PQAS descriptors: shooting, sharp, electric, hot, and radiating), (2) superficial pain (itchy, cold, numb, sensitive, and tingling), and (3) deep pain (aching, heavy, dull, cramping, and throbbing). The PQAS tender pain item did not load strongly on any of the 3 factors. The findings support the hypothesis that pain qualities cluster into distinct groups. If replicated in additional samples, the pain quality domains identified may provide clinicians and researchers with a useful way to summarize data from pain quality measures, and may also provide meaningful end points that would allow for treatment differentiation between various pharmacologic entities.

Research paper thumbnail of The Assessment of Pain Quality: An Item Response Theory Analysis

The Journal of Pain, 2010

Item Response Theory (IRT) is being increasingly used to develop and evaluate outcome measures. H... more Item Response Theory (IRT) is being increasingly used to develop and evaluate outcome measures. However, many pain measures, including those that assess pain quality, have yet to be evaluated from the IRT perspective. The current study evaluated the scales of a commonly used measure of pain quality (the Pain Quality Assessment Scale, or PQAS) using IRT analyses in 3 samples of patients with chronic pain. The findings indicated variability in the precision of the scales, suggesting that all 3 of the PQAS scales are precise when pain is severe and that the Paroxysmal and Deep scales but not necessarily the Surface scale are precise when pain is of moderate or lower severity. In addition, 2 potential problems with the 11 (ie, 0 to 10) response levels used for the PQAS items were identified: (1) a high degree of overlap between adjacent response levels and (2) a lack of interval scaling. Research is needed to determine the extent to which these problems do, or do not, threaten the validity of the PQAS items and scales as outcome measures in pain clinical trials. IRT analyses provide important information about the psychometric and practical qualities of pain measures that is not provided by standard (classical test theory) analyses. IRT analyses of the PQAS subscales indicate that some of the scales are more precise than others at different levels of pain severity and provide important directions for further research to better understand the PQAS. IRT analyses would probably similarly provide important information concerning the utility of other measures commonly used in pain research.

Research paper thumbnail of The Pain Quality Response Profile of Oxymorphone Extended Release in the Treatment of Low Back Pain

The Clinical Journal of Pain, 2009

In controlled trials of analgesics, the primary outcome variable is most often a measure of globa... more In controlled trials of analgesics, the primary outcome variable is most often a measure of global pain intensity. However, because pain is associated with a variety of pain sensations, the effects of analgesic treatments on different sensations could go undetected if specific pain qualities are not assessed. This study sought to evaluate the utility of assessing the multiple components of non-neuropathic pain in an analgesic clinical trial. A secondary analysis was performed using data from a clinical trial involving 140 individuals with low back pain who were converted from prestudy opioids to an equianalgesic dose of an extended release (ER) formulation of oxymorphone (OPANA ER), which was then titrated to a stable dose [defined as visual analog scale <or=40 mm (0 to 100 mm) on 3 of 5 consecutive days and requiring <or=2 doses rescue medication]. Stabilized participants were then randomly assigned to continue with either oxymorphone ER or placebo for 12 weeks. A multidimensional measure of pain quality, the Pain Quality Assessment Scale (PQAS), was administered before titration, after titration, and after treatment with oxymorphone ER or placebo. Significant pretitration to posttitration decreases were observed in 17 of the 20 PQAS pain descriptor items and all 3 PQAS scales. The largest effects of oxymorphone ER were found on the PQAS intense, unpleasant, deep, aching, and sharp items and the PQAS Paroxysmal and Deep scales. The results indicate that oxymorphone ER has different effects on different pain qualities of low back pain. The responsivity of the PQAS items and scales to the results of treatment with an effective and generally well-tolerated dose of an analgesic, and the ability of the PQAS items and scales to discriminate between an active analgesic and placebo, support their validity as outcome measures. The findings support the utility of using pain descriptor measures for (1) identifying the effects of pain treatments on different pain qualities and (2) targeting pain treatments to those patients who experience certain types of pain.

Research paper thumbnail of Treatment Satisfaction in Osteoarthritis and Chronic Low Back Pain: The Role of Pain, Physical and Emotional Functioning, Sleep, and Adverse Events

The Journal of Pain, 2011

Global ratings of treatment satisfaction and improvement can provide an opportunity for patients ... more Global ratings of treatment satisfaction and improvement can provide an opportunity for patients to aggregate multiple aspects of their treatment into a single measure of its perceived benefits and disadvantages. Although such measures have been recommended for chronic pain clinical trials, only limited data are available that address the hypothesis that they reflect multiple aspects of patients' treatment experience. Our objective was to identify the factors that make independent contributions to ratings of treatment satisfaction. We analyzed data from 5 open-label clinical trials of lidocaine patch 5% in osteoarthritis knee pain and chronic low back pain that were 2 to 12 weeks in duration. A total of 383 patients completed the Patient Global Assessment of Treatment Satisfaction scale and measures of pain, interference with physical and emotional functioning, sleep interference, and adverse events. The results of multivariate analyses indicated that improvements in measures of pain intensity, pain relief, and interference with physical functioning each made independent contributions to treatment satisfaction in both groups of patients. Improvements in interference with emotional functioning and sleep and the presence and severity of adverse events were not associated with satisfaction. Measures of treatment satisfaction can reflect different aspects of the patient's treatment response, including improvements in pain and physical functioning. Increased understanding of such global measures may facilitate development of clinical trial outcomes that allow patients to evaluate with minimal burden those aspects of the treatment experience they consider personally meaningful.

Research paper thumbnail of Baseline Body Mass Index (BMI) Has No Effect upon Normalization of Testosterone Concentrations with Testosterone 2% Gel

The Endocrine Society's 93rd Annual Meeting & Expo, June 4–7, 2011 - Boston, 2011

Research paper thumbnail of Normal Physiologic Testosterone Concentrations Were Obtained with Testosterone 2% Gel in Previously Treated and Treatment-Naive Hypogonadal Males

The Endocrine Society's 93rd Annual Meeting & Expo, June 4–7, 2011 - Boston, 2011

Research paper thumbnail of Genistein, a tyrosine kinase inhibitor, reduces Ca2+ mobilization in swine carotid media

The American journal of physiology, 1995

DiSalvo and colleagues (Biochem. Biophys. Res. Commun. 190: 968-974, 1993) found that tyrosine ki... more DiSalvo and colleagues (Biochem. Biophys. Res. Commun. 190: 968-974, 1993) found that tyrosine kinase inhibitors reduced force at constant Ca2+ concentrations in permeabilized mesenteric arterioles. These data suggest that tyrosine kinase activation could regulate Ca2+ sensitivity in intact vascular smooth muscle. We tested this hypothesis by examining the effects of the tyrosine kinase inhibitor genistein on intracellular Ca2+ concentration ([Ca2+]i), myosin regulatory light chain (MRLC) phosphorylation, and isometric stress in intact swine carotid media tissues. Pretreatment with 30 microM genistein attenuated histamine-induced increases in [Ca2+]i (estimated using the photoprotein aequorin), MRLC phosphorylation, and stress. The genistein-dependent decrease in [Ca2+]i quantitatively accounted for the decrease in MRLC phosphorylation and stress. There was no measurable change in the Ca2+ dependence of MRLC phosphorylation or the dependence of force on MRLC phosphorylation. Geniste...

Research paper thumbnail of Rosiglitazone increases high-density lipoprotein cholesterol levels in patients with type 2 diabetes

Journal of the American College of Cardiology, 2003

Least-square mean % changes in LDL-C and high-density lipoprotein-C (HDL-C) from baseline from an... more Least-square mean % changes in LDL-C and high-density lipoprotein-C (HDL-C) from baseline from analysis of variance RSV ATV SIM PRA N/group, range 156-161 154-165 158.165 160.164 Results: Pooled EZE + SIMV reduced LDL-C from baseline by 49.9% versus pooled SIMV alone (36.1%, PcO.01) and co-administration was superior to statin alone at each SIMV dose. Overall, median % reductrons in CRP from baseline were almost 2X greater with pooled EZE + SIMV versus pooled SIMV alone (-34.8% versus -18.2%, P<O.Ol).

Research paper thumbnail of A single perioperative dose of extended-release epidural morphine effectively delays the time to supplemental opioid use after hip arthroplasty: Analysis of 3 phase II/III trials

The Journal of Pain, 2005

Research paper thumbnail of Original Research Article Negligible Analgesic Tolerance Seen with Extended Release Oxymorphone: A Post Hoc Analysis of Open-Label Longitudinal Data

Research paper thumbnail of Poster 251: Opana ER Tolerance in Osteoarthritic Patients: A 1-Year Prospective Study

Arch Phys Med Rehabil, 2008

Research paper thumbnail of Poster 253: Challenges to Successful Titration of Chronic Low Back Pain Patients to Oxymorphone Extended Release

Research paper thumbnail of PPN8 Chronic Pain Treatment with Opioids: Practice Does Not Follow Policy

Research paper thumbnail of Negligible Analgesic Tolerance Seen with Extended Release Oxymorphone: A Post Hoc Analysis of Open-Label Longitudinal Data

Pain Medicine, 2010

Design. Post hoc analysis of data from a previously conducted prospective 1 year multi-center ope... more Design. Post hoc analysis of data from a previously conducted prospective 1 year multi-center openlabel extension study in which patients were able to titrate as needed.

Research paper thumbnail of The Assessment of Pain Quality: An Item Response Theory Analysis

The Journal of Pain, 2010

Item Response Theory (IRT) is being increasingly used to develop and evaluate outcome measures. H... more Item Response Theory (IRT) is being increasingly used to develop and evaluate outcome measures. However, many pain measures, including those that assess pain quality, have yet to be evaluated from the IRT perspective. The current study evaluated the scales of a commonly used measure of pain quality (the Pain Quality Assessment Scale, or PQAS) using IRT analyses in 3 samples of patients with chronic pain. The findings indicated variability in the precision of the scales, suggesting that all 3 of the PQAS scales are precise when pain is severe and that the Paroxysmal and Deep scales but not necessarily the Surface scale are precise when pain is of moderate or lower severity. In addition, 2 potential problems with the 11 (ie, 0 to 10) response levels used for the PQAS items were identified: (1) a high degree of overlap between adjacent response levels and (2) a lack of interval scaling. Research is needed to determine the extent to which these problems do, or do not, threaten the validity of the PQAS items and scales as outcome measures in pain clinical trials. IRT analyses provide important information about the psychometric and practical qualities of pain measures that is not provided by standard (classical test theory) analyses. IRT analyses of the PQAS subscales indicate that some of the scales are more precise than others at different levels of pain severity and provide important directions for further research to better understand the PQAS. IRT analyses would probably similarly provide important information concerning the utility of other measures commonly used in pain research.

Research paper thumbnail of (291) Chronic-pain treatment with opioids: Practice does not follow policy

The Journal of Pain, 2008

ABSTRACT

Research paper thumbnail of Chronic noncancer pain severity and interference with daily life: data from the Opioid Utilization Study (OPUS)

The Journal of Pain, 2009

Research paper thumbnail of The Relationship of Changes in Pain Quality to Pain Interference and Sleep Quality

The Journal of Pain, 2010

Pain is a complex multidimensional experience that includes overall intensity/magnitude, unpleasa... more Pain is a complex multidimensional experience that includes overall intensity/magnitude, unpleasantness/bothersomeness (affect), location, and quality. However, there is a paucity of research examining the importance of pain quality to patient functioning; most research focuses only on the intensity and affective components of pain. This study sought to address this gap by examining, in a sample of patients with carpal tunnel syndrome (CTS), the associations between pain quality and 2 domains of patient functioning: pain interference and sleep quality. We found that measures of pain quality contributed to the prediction of pain interference and sleep quality over and above the effects of global pain intensity and unpleasantness. In our sample, both throbbing and itchy pain emerged as contributing the most unique variance to the prediction of patient functioning. The findings indicate that the presence of pain described as throbbing or itchy, regardless of the overall magnitude of pain, may make patients with CTS particularly vulnerable to the negative impact of pain on quality of life. The findings support the need for experimental studies to determine if treatments can be identified that address these 2 pain qualities, and if effective treatments for these qualities in particular result in significant improvement in the quality of life of patients with CTS. A growing body of research supports the importance of assessing multiple domains of pain in clinical and research settings. The current findings suggest the possibility that, in patients with carpal tunnel syndrome, itchy and throbbing pain may play key roles in patient functioning above and beyond global pain intensity and unpleasantness. More research is needed to confirm this finding, and whether treatments can be identified that address these pain qualities specifically.

Research paper thumbnail of Extended‐release naltrexone/bupropion and liver health: Pooled, post hoc analysis from four randomized controlled trials

Diabetes, Obesity and Metabolism

Research paper thumbnail of The Relationship of Changes in Pain Quality to Pain Interference and Sleep Quality

The Journal of Pain, 2010

Pain is a complex multidimensional experience that includes overall intensity/magnitude, unpleasa... more Pain is a complex multidimensional experience that includes overall intensity/magnitude, unpleasantness/bothersomeness (affect), location, and quality. However, there is a paucity of research examining the importance of pain quality to patient functioning; most research focuses only on the intensity and affective components of pain. This study sought to address this gap by examining, in a sample of patients with carpal tunnel syndrome (CTS), the associations between pain quality and 2 domains of patient functioning: pain interference and sleep quality. We found that measures of pain quality contributed to the prediction of pain interference and sleep quality over and above the effects of global pain intensity and unpleasantness. In our sample, both throbbing and itchy pain emerged as contributing the most unique variance to the prediction of patient functioning. The findings indicate that the presence of pain described as throbbing or itchy, regardless of the overall magnitude of pain, may make patients with CTS particularly vulnerable to the negative impact of pain on quality of life. The findings support the need for experimental studies to determine if treatments can be identified that address these 2 pain qualities, and if effective treatments for these qualities in particular result in significant improvement in the quality of life of patients with CTS. A growing body of research supports the importance of assessing multiple domains of pain in clinical and research settings. The current findings suggest the possibility that, in patients with carpal tunnel syndrome, itchy and throbbing pain may play key roles in patient functioning above and beyond global pain intensity and unpleasantness. More research is needed to confirm this finding, and whether treatments can be identified that address these pain qualities specifically.

Research paper thumbnail of The Dimensions of Pain Quality: Factor Analysis of the Pain Quality Assessment Scale

The Clinical Journal of Pain, 2008

To provide a better empirical understanding of the dimensionality of neuropathic and non-neuropat... more To provide a better empirical understanding of the dimensionality of neuropathic and non-neuropathic pain quality. An exploratory factor analysis (FA) was performed with baseline pain quality data [assessed using the Pain Quality Assessment Scale (PQAS)] from patients with osteoarthritis of the knee (n=368) and low back pain (n=455) who had participated in a series of analgesic clinical trials. The results of the FA were then confirmed in a sample of patients with neuropathic pain secondary to carpal tunnel syndrome (n=138). Comparisons between the diagnostic groups on scale scores derived from the FA results were also made using t tests. Three clear pain quality factors emerged that seemed to represent (1) paroxysmal pain sensations (PQAS descriptors: shooting, sharp, electric, hot, and radiating), (2) superficial pain (itchy, cold, numb, sensitive, and tingling), and (3) deep pain (aching, heavy, dull, cramping, and throbbing). The PQAS tender pain item did not load strongly on any of the 3 factors. The findings support the hypothesis that pain qualities cluster into distinct groups. If replicated in additional samples, the pain quality domains identified may provide clinicians and researchers with a useful way to summarize data from pain quality measures, and may also provide meaningful end points that would allow for treatment differentiation between various pharmacologic entities.

Research paper thumbnail of The Assessment of Pain Quality: An Item Response Theory Analysis

The Journal of Pain, 2010

Item Response Theory (IRT) is being increasingly used to develop and evaluate outcome measures. H... more Item Response Theory (IRT) is being increasingly used to develop and evaluate outcome measures. However, many pain measures, including those that assess pain quality, have yet to be evaluated from the IRT perspective. The current study evaluated the scales of a commonly used measure of pain quality (the Pain Quality Assessment Scale, or PQAS) using IRT analyses in 3 samples of patients with chronic pain. The findings indicated variability in the precision of the scales, suggesting that all 3 of the PQAS scales are precise when pain is severe and that the Paroxysmal and Deep scales but not necessarily the Surface scale are precise when pain is of moderate or lower severity. In addition, 2 potential problems with the 11 (ie, 0 to 10) response levels used for the PQAS items were identified: (1) a high degree of overlap between adjacent response levels and (2) a lack of interval scaling. Research is needed to determine the extent to which these problems do, or do not, threaten the validity of the PQAS items and scales as outcome measures in pain clinical trials. IRT analyses provide important information about the psychometric and practical qualities of pain measures that is not provided by standard (classical test theory) analyses. IRT analyses of the PQAS subscales indicate that some of the scales are more precise than others at different levels of pain severity and provide important directions for further research to better understand the PQAS. IRT analyses would probably similarly provide important information concerning the utility of other measures commonly used in pain research.

Research paper thumbnail of The Pain Quality Response Profile of Oxymorphone Extended Release in the Treatment of Low Back Pain

The Clinical Journal of Pain, 2009

In controlled trials of analgesics, the primary outcome variable is most often a measure of globa... more In controlled trials of analgesics, the primary outcome variable is most often a measure of global pain intensity. However, because pain is associated with a variety of pain sensations, the effects of analgesic treatments on different sensations could go undetected if specific pain qualities are not assessed. This study sought to evaluate the utility of assessing the multiple components of non-neuropathic pain in an analgesic clinical trial. A secondary analysis was performed using data from a clinical trial involving 140 individuals with low back pain who were converted from prestudy opioids to an equianalgesic dose of an extended release (ER) formulation of oxymorphone (OPANA ER), which was then titrated to a stable dose [defined as visual analog scale &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;or=40 mm (0 to 100 mm) on 3 of 5 consecutive days and requiring &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;or=2 doses rescue medication]. Stabilized participants were then randomly assigned to continue with either oxymorphone ER or placebo for 12 weeks. A multidimensional measure of pain quality, the Pain Quality Assessment Scale (PQAS), was administered before titration, after titration, and after treatment with oxymorphone ER or placebo. Significant pretitration to posttitration decreases were observed in 17 of the 20 PQAS pain descriptor items and all 3 PQAS scales. The largest effects of oxymorphone ER were found on the PQAS intense, unpleasant, deep, aching, and sharp items and the PQAS Paroxysmal and Deep scales. The results indicate that oxymorphone ER has different effects on different pain qualities of low back pain. The responsivity of the PQAS items and scales to the results of treatment with an effective and generally well-tolerated dose of an analgesic, and the ability of the PQAS items and scales to discriminate between an active analgesic and placebo, support their validity as outcome measures. The findings support the utility of using pain descriptor measures for (1) identifying the effects of pain treatments on different pain qualities and (2) targeting pain treatments to those patients who experience certain types of pain.

Research paper thumbnail of Treatment Satisfaction in Osteoarthritis and Chronic Low Back Pain: The Role of Pain, Physical and Emotional Functioning, Sleep, and Adverse Events

The Journal of Pain, 2011

Global ratings of treatment satisfaction and improvement can provide an opportunity for patients ... more Global ratings of treatment satisfaction and improvement can provide an opportunity for patients to aggregate multiple aspects of their treatment into a single measure of its perceived benefits and disadvantages. Although such measures have been recommended for chronic pain clinical trials, only limited data are available that address the hypothesis that they reflect multiple aspects of patients&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; treatment experience. Our objective was to identify the factors that make independent contributions to ratings of treatment satisfaction. We analyzed data from 5 open-label clinical trials of lidocaine patch 5% in osteoarthritis knee pain and chronic low back pain that were 2 to 12 weeks in duration. A total of 383 patients completed the Patient Global Assessment of Treatment Satisfaction scale and measures of pain, interference with physical and emotional functioning, sleep interference, and adverse events. The results of multivariate analyses indicated that improvements in measures of pain intensity, pain relief, and interference with physical functioning each made independent contributions to treatment satisfaction in both groups of patients. Improvements in interference with emotional functioning and sleep and the presence and severity of adverse events were not associated with satisfaction. Measures of treatment satisfaction can reflect different aspects of the patient&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s treatment response, including improvements in pain and physical functioning. Increased understanding of such global measures may facilitate development of clinical trial outcomes that allow patients to evaluate with minimal burden those aspects of the treatment experience they consider personally meaningful.

Research paper thumbnail of Baseline Body Mass Index (BMI) Has No Effect upon Normalization of Testosterone Concentrations with Testosterone 2% Gel

The Endocrine Society's 93rd Annual Meeting & Expo, June 4–7, 2011 - Boston, 2011

Research paper thumbnail of Normal Physiologic Testosterone Concentrations Were Obtained with Testosterone 2% Gel in Previously Treated and Treatment-Naive Hypogonadal Males

The Endocrine Society's 93rd Annual Meeting & Expo, June 4–7, 2011 - Boston, 2011

Research paper thumbnail of Genistein, a tyrosine kinase inhibitor, reduces Ca2+ mobilization in swine carotid media

The American journal of physiology, 1995

DiSalvo and colleagues (Biochem. Biophys. Res. Commun. 190: 968-974, 1993) found that tyrosine ki... more DiSalvo and colleagues (Biochem. Biophys. Res. Commun. 190: 968-974, 1993) found that tyrosine kinase inhibitors reduced force at constant Ca2+ concentrations in permeabilized mesenteric arterioles. These data suggest that tyrosine kinase activation could regulate Ca2+ sensitivity in intact vascular smooth muscle. We tested this hypothesis by examining the effects of the tyrosine kinase inhibitor genistein on intracellular Ca2+ concentration ([Ca2+]i), myosin regulatory light chain (MRLC) phosphorylation, and isometric stress in intact swine carotid media tissues. Pretreatment with 30 microM genistein attenuated histamine-induced increases in [Ca2+]i (estimated using the photoprotein aequorin), MRLC phosphorylation, and stress. The genistein-dependent decrease in [Ca2+]i quantitatively accounted for the decrease in MRLC phosphorylation and stress. There was no measurable change in the Ca2+ dependence of MRLC phosphorylation or the dependence of force on MRLC phosphorylation. Geniste...

Research paper thumbnail of Rosiglitazone increases high-density lipoprotein cholesterol levels in patients with type 2 diabetes

Journal of the American College of Cardiology, 2003

Least-square mean % changes in LDL-C and high-density lipoprotein-C (HDL-C) from baseline from an... more Least-square mean % changes in LDL-C and high-density lipoprotein-C (HDL-C) from baseline from analysis of variance RSV ATV SIM PRA N/group, range 156-161 154-165 158.165 160.164 Results: Pooled EZE + SIMV reduced LDL-C from baseline by 49.9% versus pooled SIMV alone (36.1%, PcO.01) and co-administration was superior to statin alone at each SIMV dose. Overall, median % reductrons in CRP from baseline were almost 2X greater with pooled EZE + SIMV versus pooled SIMV alone (-34.8% versus -18.2%, P<O.Ol).

Research paper thumbnail of A single perioperative dose of extended-release epidural morphine effectively delays the time to supplemental opioid use after hip arthroplasty: Analysis of 3 phase II/III trials

The Journal of Pain, 2005

Research paper thumbnail of Original Research Article Negligible Analgesic Tolerance Seen with Extended Release Oxymorphone: A Post Hoc Analysis of Open-Label Longitudinal Data

Research paper thumbnail of Poster 251: Opana ER Tolerance in Osteoarthritic Patients: A 1-Year Prospective Study

Arch Phys Med Rehabil, 2008

Research paper thumbnail of Poster 253: Challenges to Successful Titration of Chronic Low Back Pain Patients to Oxymorphone Extended Release

Research paper thumbnail of PPN8 Chronic Pain Treatment with Opioids: Practice Does Not Follow Policy

Research paper thumbnail of Negligible Analgesic Tolerance Seen with Extended Release Oxymorphone: A Post Hoc Analysis of Open-Label Longitudinal Data

Pain Medicine, 2010

Design. Post hoc analysis of data from a previously conducted prospective 1 year multi-center ope... more Design. Post hoc analysis of data from a previously conducted prospective 1 year multi-center openlabel extension study in which patients were able to titrate as needed.

Research paper thumbnail of The Assessment of Pain Quality: An Item Response Theory Analysis

The Journal of Pain, 2010

Item Response Theory (IRT) is being increasingly used to develop and evaluate outcome measures. H... more Item Response Theory (IRT) is being increasingly used to develop and evaluate outcome measures. However, many pain measures, including those that assess pain quality, have yet to be evaluated from the IRT perspective. The current study evaluated the scales of a commonly used measure of pain quality (the Pain Quality Assessment Scale, or PQAS) using IRT analyses in 3 samples of patients with chronic pain. The findings indicated variability in the precision of the scales, suggesting that all 3 of the PQAS scales are precise when pain is severe and that the Paroxysmal and Deep scales but not necessarily the Surface scale are precise when pain is of moderate or lower severity. In addition, 2 potential problems with the 11 (ie, 0 to 10) response levels used for the PQAS items were identified: (1) a high degree of overlap between adjacent response levels and (2) a lack of interval scaling. Research is needed to determine the extent to which these problems do, or do not, threaten the validity of the PQAS items and scales as outcome measures in pain clinical trials. IRT analyses provide important information about the psychometric and practical qualities of pain measures that is not provided by standard (classical test theory) analyses. IRT analyses of the PQAS subscales indicate that some of the scales are more precise than others at different levels of pain severity and provide important directions for further research to better understand the PQAS. IRT analyses would probably similarly provide important information concerning the utility of other measures commonly used in pain research.

Research paper thumbnail of (291) Chronic-pain treatment with opioids: Practice does not follow policy

The Journal of Pain, 2008

ABSTRACT

Research paper thumbnail of Chronic noncancer pain severity and interference with daily life: data from the Opioid Utilization Study (OPUS)

The Journal of Pain, 2009

Research paper thumbnail of The Relationship of Changes in Pain Quality to Pain Interference and Sleep Quality

The Journal of Pain, 2010

Pain is a complex multidimensional experience that includes overall intensity/magnitude, unpleasa... more Pain is a complex multidimensional experience that includes overall intensity/magnitude, unpleasantness/bothersomeness (affect), location, and quality. However, there is a paucity of research examining the importance of pain quality to patient functioning; most research focuses only on the intensity and affective components of pain. This study sought to address this gap by examining, in a sample of patients with carpal tunnel syndrome (CTS), the associations between pain quality and 2 domains of patient functioning: pain interference and sleep quality. We found that measures of pain quality contributed to the prediction of pain interference and sleep quality over and above the effects of global pain intensity and unpleasantness. In our sample, both throbbing and itchy pain emerged as contributing the most unique variance to the prediction of patient functioning. The findings indicate that the presence of pain described as throbbing or itchy, regardless of the overall magnitude of pain, may make patients with CTS particularly vulnerable to the negative impact of pain on quality of life. The findings support the need for experimental studies to determine if treatments can be identified that address these 2 pain qualities, and if effective treatments for these qualities in particular result in significant improvement in the quality of life of patients with CTS. A growing body of research supports the importance of assessing multiple domains of pain in clinical and research settings. The current findings suggest the possibility that, in patients with carpal tunnel syndrome, itchy and throbbing pain may play key roles in patient functioning above and beyond global pain intensity and unpleasantness. More research is needed to confirm this finding, and whether treatments can be identified that address these pain qualities specifically.