Celeste Elash - Academia.edu (original) (raw)

Papers by Celeste Elash

Research paper thumbnail of Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies

Therapeutic Innovation & Regulatory Science

Background Visual analogue scales (VASs) are used in a variety of patient-, observer- and clinici... more Background Visual analogue scales (VASs) are used in a variety of patient-, observer- and clinician-reported outcome measures. While typically included in measures originally developed for pen-and-paper completion, a greater number of clinical trials currently use electronic approaches to their collection. This leads researchers to question whether the measurement properties of the scale have been conserved during the migration to an electronic format, particularly because electronic formats often use a different scale length than the 100 mm paper standard. Methods We performed a review of published studies investigating the measurement comparability of paper and electronic formats of the VAS. Results Our literature search yielded 26 studies published between 1997 and 2018 that reported comparison of paper and electronic formats using the VAS. After excluding 2 publications, 23 of the remaining 24 studies included in this review reported electronic formats of the VAS (eVAS) and pape...

Research paper thumbnail of Best Practices for Development or Migration of PRO Measures for Use on Multiple Data Collection Modes

Research paper thumbnail of See Profile

Research paper thumbnail of Endometriosis Pain Daily Diary

Research paper thumbnail of Best Practices for Avoiding Paper Backup When Implementing Electronic Approaches to Patient-Reported Outcome Data Collection in Clinical Trials

Therapeutic Innovation & Regulatory Science, 2019

is the Director of eCOA Sciences for YPrime. Throughout her 25-year industry career, Celeste has ... more is the Director of eCOA Sciences for YPrime. Throughout her 25-year industry career, Celeste has served as a clinical research scientist, with a variety of contributions for the advancement of patient-focused drug development and eCOA adoption. Prior to joining YPrime, Celeste served as an independent consultant to biopharmaceutical companies and clinical science advisor for two eCOA providers. She has also done clinical research for Purdue University, The University of Pittsburgh and Western Psychiatric Institute and Clinic. Her experience spans more than 150 domestic and global clinical trials, academic research projects, and qualitative research projects.

Research paper thumbnail of Patient Reported Outcomes (PROs) used in recent Phase 3 trials for Type 2 Diabetes: A review of concepts assessed by these PROs and factors to consider when choosing a PRO for future trials

Diabetes Research and Clinical Practice, 2016

AIMS Many treatment options are available for people with Type 2 Diabetes (T2D). While the goal o... more AIMS Many treatment options are available for people with Type 2 Diabetes (T2D). While the goal of treatment is to reach target HbA1c levels, the psychological experience may be more tangible and meaningful for the patient. Together with biomarkers, Patient-Reported Outcome (PRO) data provide a holistic understanding of the clinical and psychosocial impact of T2D and its treatment. METHODS A literature review was conducted in multiple databases to identify PRO endpoints used in Phase 3 trials of newer classes of drugs for the treatment of T2D. RESULTS This review identified five PRO concepts which were evaluated as endpoints in Phase 3 trials of GLP-1 receptor agonists, novel insulins, SGLT-2 inhibitors, and DPP-4 inhibitors; symptoms, health-related quality of life, psychological well-being, satisfaction with treatment/health and impact of weight. Twenty PRO questionnaires were used to measure these concepts/endpoints directly from patients. The relevance of, and scientific basis for, these concepts as endpoints are discussed, the similarities and differences between questionnaires targeting the same concepts/endpoints are explored, and the sensitivity of the questionnaires to the experimental intervention is summarized. In addition, factors that should be considered when choosing PROs for future T2D trials are discussed. CONCLUSIONS The information gained from PROs in clinical trial research is important in defining treatment benefit within the context of the trial, and the potential benefit (i.e. better adherence) in clinical practice. However, variable results have been observed in recent trials and careful and systematic consideration should be given to PRO selection for future studies of T2D.

Research paper thumbnail of Patient Reported Outcomes in the Development of new Medications for Type 2 Diabetes: a Review of Recently Approved Products

Value in Health, 2015

A715 predominantly positive. However, experts refer to methodological deficits and only few would... more A715 predominantly positive. However, experts refer to methodological deficits and only few would recommend the use of the instruments in practice. ConClusions: There are many questionnaires to assess workability and related concepts. However, only few seem to be scientifically sound and valid and at the same time applicable for a broad use in practice.

Research paper thumbnail of Content Validity for the VVSymQ® Instrument: A New Patient-Reported Outcome Measure for the Assessment of Varicose Veins Symptoms

The Patient - Patient-Centered Outcomes Research, 2016

Background Varicose veins are common and can impact patients' quality of life, but consensus rega... more Background Varicose veins are common and can impact patients' quality of life, but consensus regarding the evaluation of varicose vein symptoms is lacking and existing measures have limitations. Objective This research aimed to develop and establish the content validity of a new electronic patient-reported outcome (PRO) measure, the VVSymQ Ò instrument, to assess symptoms of superficial venous insufficiency (varicose veins) in clinical trials. Methods The development of the VVSymQ Ò instrument began with qualitative interviews with patients based on the symptom domain of the VEINES-QOL/Sym, an existing PRO instrument for chronic venous disorders of the leg. Three phases of qualitative research were conducted to examine the relevance and importance of the symptoms to patients with varicose veins, and the patients' ability to understand and use the VVSymQ Ò instrument. The development included evaluating questions that had 1-week and 24-h recall periods, and paper and electronic versions of the new instrument. Results Five symptoms (heaviness, achiness, swelling, throbbing, and itching [HASTI TM ]) were consistently reported by patients across all sources of qualitative data. The final version of the VVSymQ Ò instrument queries patients on the HASTI TM symptoms using a 24-h recall period and a 6-point duration-based response scale ranging from ''None of the time'' to ''All of the time,'' and is administered daily via an electronic diary. Cognitive interviews demonstrated varicose vein patients' understanding of and their ability to use the final version of the VVSymQ Ò instrument. Conclusion Content validity was established for the VVSymQ Ò instrument, which assesses the five HASTI TM symptoms of varicose veins daily via an electronic diary and has promise for use in research and practice.

Research paper thumbnail of A Comprehensive Disease Model of Polycystic Ovary Syndrome (Pcos)

Value in Health, 2015

were identified. After removing duplicates, 1,525 citations were screened. Of these, 159 full tex... more were identified. After removing duplicates, 1,525 citations were screened. Of these, 159 full text references were reviewed and 85 systematic reviews met predefined inclusion criteria. Five QA methods were most commonly employed: Newcastle-Ottawa Quality Assessment Scale (NOS) or modified NOS (28%); checklists developed by authors (15%); the Cochrane checklist or modified version (11%); modified checklists from other authors (5%); applying disease-specific QA tools (5%). The reliability and applicability of the most commonly employed tool in this research field, NOS, were questioned in included reviews, corresponding with concerns on the validity of the NOS reported in recently published literature of research methodology. ConClusions: The available evidence demonstrates a lack of consensus on the use of QA tools for non-RCTs assessing surgical interventions. Various methods have been adapted or newly developed by researchers, and the most commonly applied QA tool (NOS) may not be fit for purpose in this field of research. There is an urgent need for a validated QA tool to appraise the quality of evidence to help inform evidence-based decision making on the use of surgical devices and types of surgical approaches.

Research paper thumbnail of Equivalence of Paper and Electronic Administration of Patient Reported Outcomes: a Comparison in Psoriatic Arthritis

Research paper thumbnail of The Conceptual Framework and Content Validity of the Polycystic Ovary Syndrome Patient Reported Outcome (Pcos-Pro) Scale

Value in Health, 2015

23 items, accounting for 72.8% of variance. Internal reliability for the 3 domains was high (Cron... more 23 items, accounting for 72.8% of variance. Internal reliability for the 3 domains was high (Cronbach's α .84-.96), as was test-retest reliability (intra-class correlation .81-.96). Concurrent validity was demonstrated through highly significant relationships with relevant domains of the SF-36 and the EQ-5D-5L. ConClusions: Preliminary results suggest that the Ox-PAQ is a short, valid and reliable measure of participation and activity. The measure will now be validated in a range of further conditions and additional properties, such as sensitivity to change and predictive validity, will also be assessed in the next phase of the instrument's development.

Research paper thumbnail of Imagery and the startle probe reflex: The manipulation of smoking urges and mood

Experimental and Clinical Psychopharmacology

Research paper thumbnail of The VVSymQ® instrument: Use of a new patient-reported outcome measure for assessment of varicose vein symptoms

Phlebology / Venous Forum of the Royal Society of Medicine, Jan 15, 2015

No existing patient-reported outcome instrument focuses solely on assessment of varicose veins sy... more No existing patient-reported outcome instrument focuses solely on assessment of varicose veins symptoms that are bothersome to patients. The VVSymQ® instrument is a five-item patient-reported outcome that assesses symptoms most important to patients with varicose veins (heaviness, achiness, swelling, throbbing and itching). This paper describes how the VVSymQ® instrument was incorporated into an electronic daily diary to monitor key outcomes over time and capture treatment benefit in two randomized, controlled, phase 3 clinical trials. Patients were highly compliant in completing the electronic daily diary, and the VVSymQ® instrument demonstrated ability to detect overall change and ability to detect change that is meaningful to patients. The VVSymQ® instrument is a reliable, valid instrument responsive to measuring change in the patient experience of varicose vein symptoms pre- and post-intervention, and is uniquely focused on patient-reported symptoms compared with other widely us...

Research paper thumbnail of Development And Content Validity Of A Pediatric Functional Constipation Daily Diary

Research paper thumbnail of Content Validity Of A Patient-Reported Outcome Instrument For Pancreatic Cancer

Research paper thumbnail of Development And Content Validity Of An Endometriosis Pain Daily Diary

Value in Health, 2013

those included in the 1-year and change analyses completed the SF-36 within 30days of their 1-yea... more those included in the 1-year and change analyses completed the SF-36 within 30days of their 1-year follow-up date. RESULTS: All patients contributed to the baseline analysis, and approximately 47% contributed to the 1-year and change analyses. At baseline, mean SF-6D values for all patients 50-59, 60-69, and 70-79 were 0.744 (SD=0.113), 0.743 (SD=0.105), and 0.722 (SD=0.101), respectively. At 1year, E+P arm mean values were 0.754 (SD=0.117), 0.751 (SD=0.117), and 0.725 (SD=0.109), and placebo arm mean values were 0.751 (SD=0.122), 0.748 (SD=0.109), and 0.716 (SD=0.106), respectively. The E+P arm mean changes were-0.008 (SD=0.106),-0.004 (SD=0.096), and 0.000 (SD=0.093), and the placebo arm mean changes were 0.000 (SD=0.105),-0.003 (SD=0.095), and 0.011 (SD=0.093), respectively. CONCLUSIONS: We found minimally decreasing utilities among older age groups, and little variability between utilities by hormone replacement therapy use. These results may be particularly useful in future health economic evaluations of aging women given that they are derived from a large randomized sample, and age group specific. However, our findings may be limited by the homogeneity and representativeness of the E+P trial participants.

Research paper thumbnail of The effect of bupropion on nicotine craving and withdrawal

Psychopharmacology, 2000

Rationale and objectives: Bupropion has demonstrated efficacy for smoking cessation. Given the im... more Rationale and objectives: Bupropion has demonstrated efficacy for smoking cessation. Given the importance of nicotine craving and withdrawal in the smoking cessation process, the current study examined the effects of bupropion on these parameters during smoking abstinence. Methods: During a 2-day Baseline phase with ad lib smoking, 91 non-depressed smokers (who were not trying to quit permanently) were administered measures of nicotine craving, withdrawal symptoms, and timed measures of cognitive performance five times daily. Participants were then assigned randomly to a 14-day treatment regimen with bupropion 300 mg/day, bupropion 150 mg/day, or placebo. Thereafter, the above measures were re-administered during 3 days of abstinence on a closed research ward. Results: Relative to placebo, 300 mg bupropion significantly reduced abstinence-associated increases in rated depression, difficulty concentrating, and irritability, and attenuated a decrease in positive affect. The results also suggested that bupropion might have a positive effect on performance measures during the withdrawal period. No effects were observed on craving, anxiety, restlessness, or hunger. The lack of findings on craving measures may be explained by a floor effect; except on the first day of abstinence, neither drug nor placebo groups showed much craving elevation during abstinence. Conclusions: Study results indicate that bupropion ameliorates some nicotine withdrawal symptoms.

Research paper thumbnail of Effects of transdermal nicotine patches on abstinence-induced and cue-elicited craving in cigarette smokers

Journal of Consulting and Clinical Psychology, 2000

The impact of a transdermal nicotine patch on smokers' craving for cigarettes and reactivity to s... more The impact of a transdermal nicotine patch on smokers' craving for cigarettes and reactivity to smoking cues was investigated. Sixty-one smokers were assessed during 2 sessions separated by 6 hr. Cue reactivity to imaginal and in vivo smoking and nonsmoking stimuli was evaluated during both sessions. During the interval between sessions, participants were abstinent from cigarettes and wore either a nicotine transdermal (21 mg) or placebo patch. In both sessions, exposure to in vivo and imaginal smoking stimuli elicited cue-specific increases in craving, negative affect, vividness, heart rate, and skin conductance. The nicotine patch attenuated craving and other effects induced by abstinence from cigarettes but had no selective impact on craving or any other reaction elicited by smoking cues. These results are discussed in terms of models of craving and clinical implications of transdermal nicotine for craving reduction.

Research paper thumbnail of Manipulation of smoking urges and affect through a brief-imagery procedure: Self-report, psychophysiological, and startle probe responses

Experimental and Clinical Psychopharmacology, 1995

The extent to which sentence imagery elicits effects comparable to those produced by long narrati... more The extent to which sentence imagery elicits effects comparable to those produced by long narratives was investigated. Smokers imagined sentences with varying affective content and that either contained or were devoid of smoking cues. Physiological responses were monitored, and smokers rated their urges and affect. Startle responses were also collected as an index of negative affect processing. Smoking-cue sentences produced augmented urges and startle responding. Smoking material also elevated negative affect during imagery of positive affect sentences. The affect manipulation produced changes in self-reported affect and facial electomyography consistent with the affective valence of the sentences. This procedure is similar to narrative imagery in the manipulation of smoking urges and affect under laboratory conditions. Results support the hypothesis that smoking urges enhance negative affect processing. Contemporary accounts of smoking behavior suggest that urges are significant contributors to both the maintenance of cigarette smoking and the high rate of relapse experienced typically by smokers after a period of abstinence (e.g., Kozlowski

Research paper thumbnail of A technique for rapid, reliable assessment of thermal-pain threshold in humans

Behavior Research Methods, Instruments, & Computers, 1992

A simple and reliable method of assessing pain threshold in humans may be useful in a number of r... more A simple and reliable method of assessing pain threshold in humans may be useful in a number of research areas, such as in examining acute antinociceptive effects of drugs. We have developed a low-cost, computer-controlled method to reliably assess thermal-pain threshold using radiant heat focused from a slide projector and applied to a small area of skin. An electronic shutter is attached to the projector opening to provide precise onset and offset of heat. A computer keypad allows for subject response at the point of pain onset (i.e., threshold), with latency to threshold determined by computer timer. The details of the apparatus setup, subject preparation, and instructions to subjects are presented. The development of the method is described, and sources of unreliability are identified. Coefficients of variation (eVs) are calculated to provide a measure of variability within subjects across trial exposures and across sessions. Results indicate that the method is reliable for determining pain threshold, especially within sessions, and can be employed with relatively minimal expense and subject preparation.

Research paper thumbnail of Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies

Therapeutic Innovation & Regulatory Science

Background Visual analogue scales (VASs) are used in a variety of patient-, observer- and clinici... more Background Visual analogue scales (VASs) are used in a variety of patient-, observer- and clinician-reported outcome measures. While typically included in measures originally developed for pen-and-paper completion, a greater number of clinical trials currently use electronic approaches to their collection. This leads researchers to question whether the measurement properties of the scale have been conserved during the migration to an electronic format, particularly because electronic formats often use a different scale length than the 100 mm paper standard. Methods We performed a review of published studies investigating the measurement comparability of paper and electronic formats of the VAS. Results Our literature search yielded 26 studies published between 1997 and 2018 that reported comparison of paper and electronic formats using the VAS. After excluding 2 publications, 23 of the remaining 24 studies included in this review reported electronic formats of the VAS (eVAS) and pape...

Research paper thumbnail of Best Practices for Development or Migration of PRO Measures for Use on Multiple Data Collection Modes

Research paper thumbnail of See Profile

Research paper thumbnail of Endometriosis Pain Daily Diary

Research paper thumbnail of Best Practices for Avoiding Paper Backup When Implementing Electronic Approaches to Patient-Reported Outcome Data Collection in Clinical Trials

Therapeutic Innovation & Regulatory Science, 2019

is the Director of eCOA Sciences for YPrime. Throughout her 25-year industry career, Celeste has ... more is the Director of eCOA Sciences for YPrime. Throughout her 25-year industry career, Celeste has served as a clinical research scientist, with a variety of contributions for the advancement of patient-focused drug development and eCOA adoption. Prior to joining YPrime, Celeste served as an independent consultant to biopharmaceutical companies and clinical science advisor for two eCOA providers. She has also done clinical research for Purdue University, The University of Pittsburgh and Western Psychiatric Institute and Clinic. Her experience spans more than 150 domestic and global clinical trials, academic research projects, and qualitative research projects.

Research paper thumbnail of Patient Reported Outcomes (PROs) used in recent Phase 3 trials for Type 2 Diabetes: A review of concepts assessed by these PROs and factors to consider when choosing a PRO for future trials

Diabetes Research and Clinical Practice, 2016

AIMS Many treatment options are available for people with Type 2 Diabetes (T2D). While the goal o... more AIMS Many treatment options are available for people with Type 2 Diabetes (T2D). While the goal of treatment is to reach target HbA1c levels, the psychological experience may be more tangible and meaningful for the patient. Together with biomarkers, Patient-Reported Outcome (PRO) data provide a holistic understanding of the clinical and psychosocial impact of T2D and its treatment. METHODS A literature review was conducted in multiple databases to identify PRO endpoints used in Phase 3 trials of newer classes of drugs for the treatment of T2D. RESULTS This review identified five PRO concepts which were evaluated as endpoints in Phase 3 trials of GLP-1 receptor agonists, novel insulins, SGLT-2 inhibitors, and DPP-4 inhibitors; symptoms, health-related quality of life, psychological well-being, satisfaction with treatment/health and impact of weight. Twenty PRO questionnaires were used to measure these concepts/endpoints directly from patients. The relevance of, and scientific basis for, these concepts as endpoints are discussed, the similarities and differences between questionnaires targeting the same concepts/endpoints are explored, and the sensitivity of the questionnaires to the experimental intervention is summarized. In addition, factors that should be considered when choosing PROs for future T2D trials are discussed. CONCLUSIONS The information gained from PROs in clinical trial research is important in defining treatment benefit within the context of the trial, and the potential benefit (i.e. better adherence) in clinical practice. However, variable results have been observed in recent trials and careful and systematic consideration should be given to PRO selection for future studies of T2D.

Research paper thumbnail of Patient Reported Outcomes in the Development of new Medications for Type 2 Diabetes: a Review of Recently Approved Products

Value in Health, 2015

A715 predominantly positive. However, experts refer to methodological deficits and only few would... more A715 predominantly positive. However, experts refer to methodological deficits and only few would recommend the use of the instruments in practice. ConClusions: There are many questionnaires to assess workability and related concepts. However, only few seem to be scientifically sound and valid and at the same time applicable for a broad use in practice.

Research paper thumbnail of Content Validity for the VVSymQ® Instrument: A New Patient-Reported Outcome Measure for the Assessment of Varicose Veins Symptoms

The Patient - Patient-Centered Outcomes Research, 2016

Background Varicose veins are common and can impact patients' quality of life, but consensus rega... more Background Varicose veins are common and can impact patients' quality of life, but consensus regarding the evaluation of varicose vein symptoms is lacking and existing measures have limitations. Objective This research aimed to develop and establish the content validity of a new electronic patient-reported outcome (PRO) measure, the VVSymQ Ò instrument, to assess symptoms of superficial venous insufficiency (varicose veins) in clinical trials. Methods The development of the VVSymQ Ò instrument began with qualitative interviews with patients based on the symptom domain of the VEINES-QOL/Sym, an existing PRO instrument for chronic venous disorders of the leg. Three phases of qualitative research were conducted to examine the relevance and importance of the symptoms to patients with varicose veins, and the patients' ability to understand and use the VVSymQ Ò instrument. The development included evaluating questions that had 1-week and 24-h recall periods, and paper and electronic versions of the new instrument. Results Five symptoms (heaviness, achiness, swelling, throbbing, and itching [HASTI TM ]) were consistently reported by patients across all sources of qualitative data. The final version of the VVSymQ Ò instrument queries patients on the HASTI TM symptoms using a 24-h recall period and a 6-point duration-based response scale ranging from ''None of the time'' to ''All of the time,'' and is administered daily via an electronic diary. Cognitive interviews demonstrated varicose vein patients' understanding of and their ability to use the final version of the VVSymQ Ò instrument. Conclusion Content validity was established for the VVSymQ Ò instrument, which assesses the five HASTI TM symptoms of varicose veins daily via an electronic diary and has promise for use in research and practice.

Research paper thumbnail of A Comprehensive Disease Model of Polycystic Ovary Syndrome (Pcos)

Value in Health, 2015

were identified. After removing duplicates, 1,525 citations were screened. Of these, 159 full tex... more were identified. After removing duplicates, 1,525 citations were screened. Of these, 159 full text references were reviewed and 85 systematic reviews met predefined inclusion criteria. Five QA methods were most commonly employed: Newcastle-Ottawa Quality Assessment Scale (NOS) or modified NOS (28%); checklists developed by authors (15%); the Cochrane checklist or modified version (11%); modified checklists from other authors (5%); applying disease-specific QA tools (5%). The reliability and applicability of the most commonly employed tool in this research field, NOS, were questioned in included reviews, corresponding with concerns on the validity of the NOS reported in recently published literature of research methodology. ConClusions: The available evidence demonstrates a lack of consensus on the use of QA tools for non-RCTs assessing surgical interventions. Various methods have been adapted or newly developed by researchers, and the most commonly applied QA tool (NOS) may not be fit for purpose in this field of research. There is an urgent need for a validated QA tool to appraise the quality of evidence to help inform evidence-based decision making on the use of surgical devices and types of surgical approaches.

Research paper thumbnail of Equivalence of Paper and Electronic Administration of Patient Reported Outcomes: a Comparison in Psoriatic Arthritis

Research paper thumbnail of The Conceptual Framework and Content Validity of the Polycystic Ovary Syndrome Patient Reported Outcome (Pcos-Pro) Scale

Value in Health, 2015

23 items, accounting for 72.8% of variance. Internal reliability for the 3 domains was high (Cron... more 23 items, accounting for 72.8% of variance. Internal reliability for the 3 domains was high (Cronbach's α .84-.96), as was test-retest reliability (intra-class correlation .81-.96). Concurrent validity was demonstrated through highly significant relationships with relevant domains of the SF-36 and the EQ-5D-5L. ConClusions: Preliminary results suggest that the Ox-PAQ is a short, valid and reliable measure of participation and activity. The measure will now be validated in a range of further conditions and additional properties, such as sensitivity to change and predictive validity, will also be assessed in the next phase of the instrument's development.

Research paper thumbnail of Imagery and the startle probe reflex: The manipulation of smoking urges and mood

Experimental and Clinical Psychopharmacology

Research paper thumbnail of The VVSymQ® instrument: Use of a new patient-reported outcome measure for assessment of varicose vein symptoms

Phlebology / Venous Forum of the Royal Society of Medicine, Jan 15, 2015

No existing patient-reported outcome instrument focuses solely on assessment of varicose veins sy... more No existing patient-reported outcome instrument focuses solely on assessment of varicose veins symptoms that are bothersome to patients. The VVSymQ® instrument is a five-item patient-reported outcome that assesses symptoms most important to patients with varicose veins (heaviness, achiness, swelling, throbbing and itching). This paper describes how the VVSymQ® instrument was incorporated into an electronic daily diary to monitor key outcomes over time and capture treatment benefit in two randomized, controlled, phase 3 clinical trials. Patients were highly compliant in completing the electronic daily diary, and the VVSymQ® instrument demonstrated ability to detect overall change and ability to detect change that is meaningful to patients. The VVSymQ® instrument is a reliable, valid instrument responsive to measuring change in the patient experience of varicose vein symptoms pre- and post-intervention, and is uniquely focused on patient-reported symptoms compared with other widely us...

Research paper thumbnail of Development And Content Validity Of A Pediatric Functional Constipation Daily Diary

Research paper thumbnail of Content Validity Of A Patient-Reported Outcome Instrument For Pancreatic Cancer

Research paper thumbnail of Development And Content Validity Of An Endometriosis Pain Daily Diary

Value in Health, 2013

those included in the 1-year and change analyses completed the SF-36 within 30days of their 1-yea... more those included in the 1-year and change analyses completed the SF-36 within 30days of their 1-year follow-up date. RESULTS: All patients contributed to the baseline analysis, and approximately 47% contributed to the 1-year and change analyses. At baseline, mean SF-6D values for all patients 50-59, 60-69, and 70-79 were 0.744 (SD=0.113), 0.743 (SD=0.105), and 0.722 (SD=0.101), respectively. At 1year, E+P arm mean values were 0.754 (SD=0.117), 0.751 (SD=0.117), and 0.725 (SD=0.109), and placebo arm mean values were 0.751 (SD=0.122), 0.748 (SD=0.109), and 0.716 (SD=0.106), respectively. The E+P arm mean changes were-0.008 (SD=0.106),-0.004 (SD=0.096), and 0.000 (SD=0.093), and the placebo arm mean changes were 0.000 (SD=0.105),-0.003 (SD=0.095), and 0.011 (SD=0.093), respectively. CONCLUSIONS: We found minimally decreasing utilities among older age groups, and little variability between utilities by hormone replacement therapy use. These results may be particularly useful in future health economic evaluations of aging women given that they are derived from a large randomized sample, and age group specific. However, our findings may be limited by the homogeneity and representativeness of the E+P trial participants.

Research paper thumbnail of The effect of bupropion on nicotine craving and withdrawal

Psychopharmacology, 2000

Rationale and objectives: Bupropion has demonstrated efficacy for smoking cessation. Given the im... more Rationale and objectives: Bupropion has demonstrated efficacy for smoking cessation. Given the importance of nicotine craving and withdrawal in the smoking cessation process, the current study examined the effects of bupropion on these parameters during smoking abstinence. Methods: During a 2-day Baseline phase with ad lib smoking, 91 non-depressed smokers (who were not trying to quit permanently) were administered measures of nicotine craving, withdrawal symptoms, and timed measures of cognitive performance five times daily. Participants were then assigned randomly to a 14-day treatment regimen with bupropion 300 mg/day, bupropion 150 mg/day, or placebo. Thereafter, the above measures were re-administered during 3 days of abstinence on a closed research ward. Results: Relative to placebo, 300 mg bupropion significantly reduced abstinence-associated increases in rated depression, difficulty concentrating, and irritability, and attenuated a decrease in positive affect. The results also suggested that bupropion might have a positive effect on performance measures during the withdrawal period. No effects were observed on craving, anxiety, restlessness, or hunger. The lack of findings on craving measures may be explained by a floor effect; except on the first day of abstinence, neither drug nor placebo groups showed much craving elevation during abstinence. Conclusions: Study results indicate that bupropion ameliorates some nicotine withdrawal symptoms.

Research paper thumbnail of Effects of transdermal nicotine patches on abstinence-induced and cue-elicited craving in cigarette smokers

Journal of Consulting and Clinical Psychology, 2000

The impact of a transdermal nicotine patch on smokers' craving for cigarettes and reactivity to s... more The impact of a transdermal nicotine patch on smokers' craving for cigarettes and reactivity to smoking cues was investigated. Sixty-one smokers were assessed during 2 sessions separated by 6 hr. Cue reactivity to imaginal and in vivo smoking and nonsmoking stimuli was evaluated during both sessions. During the interval between sessions, participants were abstinent from cigarettes and wore either a nicotine transdermal (21 mg) or placebo patch. In both sessions, exposure to in vivo and imaginal smoking stimuli elicited cue-specific increases in craving, negative affect, vividness, heart rate, and skin conductance. The nicotine patch attenuated craving and other effects induced by abstinence from cigarettes but had no selective impact on craving or any other reaction elicited by smoking cues. These results are discussed in terms of models of craving and clinical implications of transdermal nicotine for craving reduction.

Research paper thumbnail of Manipulation of smoking urges and affect through a brief-imagery procedure: Self-report, psychophysiological, and startle probe responses

Experimental and Clinical Psychopharmacology, 1995

The extent to which sentence imagery elicits effects comparable to those produced by long narrati... more The extent to which sentence imagery elicits effects comparable to those produced by long narratives was investigated. Smokers imagined sentences with varying affective content and that either contained or were devoid of smoking cues. Physiological responses were monitored, and smokers rated their urges and affect. Startle responses were also collected as an index of negative affect processing. Smoking-cue sentences produced augmented urges and startle responding. Smoking material also elevated negative affect during imagery of positive affect sentences. The affect manipulation produced changes in self-reported affect and facial electomyography consistent with the affective valence of the sentences. This procedure is similar to narrative imagery in the manipulation of smoking urges and affect under laboratory conditions. Results support the hypothesis that smoking urges enhance negative affect processing. Contemporary accounts of smoking behavior suggest that urges are significant contributors to both the maintenance of cigarette smoking and the high rate of relapse experienced typically by smokers after a period of abstinence (e.g., Kozlowski

Research paper thumbnail of A technique for rapid, reliable assessment of thermal-pain threshold in humans

Behavior Research Methods, Instruments, & Computers, 1992

A simple and reliable method of assessing pain threshold in humans may be useful in a number of r... more A simple and reliable method of assessing pain threshold in humans may be useful in a number of research areas, such as in examining acute antinociceptive effects of drugs. We have developed a low-cost, computer-controlled method to reliably assess thermal-pain threshold using radiant heat focused from a slide projector and applied to a small area of skin. An electronic shutter is attached to the projector opening to provide precise onset and offset of heat. A computer keypad allows for subject response at the point of pain onset (i.e., threshold), with latency to threshold determined by computer timer. The details of the apparatus setup, subject preparation, and instructions to subjects are presented. The development of the method is described, and sources of unreliability are identified. Coefficients of variation (eVs) are calculated to provide a measure of variability within subjects across trial exposures and across sessions. Results indicate that the method is reliable for determining pain threshold, especially within sessions, and can be employed with relatively minimal expense and subject preparation.