Recommendations on the Selection, Development, and Modification of Performance Outcome Assessments: A Good Practices Report of an ISPOR Task Force

Authors: Edgar, Chris J., Bush, Elizabeth (Nicki), Adams, Heather R., Ballinger, Rachel, Byrom, Bill, Campbell, Michelle, Eremenco, Sonya, McDougall, Fiona, Papadopoulos, Elektra, Slagle, Ashley F., Coons, Stephen Joel

Source: Value in health. 26(7):959-967

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100193633027.0x000001&indx=1&recIds=ETOCvdc_100193633027.0x000001

Measuring the patient experience of chronic rhinosinusitis with nasal polyposis: qualitative development of a novel symptom diary

Authors: O'Quinn, Sean, Shih, Vivian H., Martin, Ubaldo J., Meyers, Oren, Crooks, Patrick, Bailey, Julie, Slagle, Ashley F.

Source: International forum of allergy & rhinology. 12(8):996-1005

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100156630064.0x000001&indx=1&recIds=ETOCvdc_100156630064.0x000001

Leveraging sensor-based functional outcomes to enhance understanding of the patient experience: challenges and opportunities.

Authors: Keyloun, Katelyn R., Abel, Jessica, Garcia, Julia K., Papadopoulos, Elektra J., Carson, Robyn T., Gwaltney, Chad, Slagle, Ashley F., Byrom, Bill

Source: Expert Review of Pharmacoeconomics & Outcomes Research; Jul2024, Vol. 24 Issue 6, p723-730, 8p

Self-stigma in chronic hepatitis B: content and psychometric validation of a new patient-reported outcome instrument

Authors: Gish, Robert G., Toumi, Mondher, Wallace, Jack, Cohen, Chari, Wang, Su, Marshall, Chris, Kitchen, Helen, Macey, Jake, Pegram, Hannah, Houts, Carrie, Mangrum, Rikki, Slagle, Ashley F., Lazarus, Jeffrey, Kennedy, Patrick, van Bömmel, Florian, Brunetto, Maurizia, Ning, Qin, Yatsuhashi, Hiroshi, Cornberg, Markus, Xie, Qing, Lee, Dee, Keever, Angelina Villasis, Sbarigia, Urbano, Takahashi, Yasushi, Jerzorwski, John, Talloen, Willem, Biermer, Michael, Chan, Eric

Source: Journal of hepatology. 78(S1):S1087-S1088

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100194674952.0x000001&indx=1&recIds=ETOCvdc_100194674952.0x000001

Experience and impact of stigma in people with chronic hepatitis B: a qualitative study in Asia, Europe, and the United States.

Authors: Toumi, Mondher, Wallace, Jack, Cohen, Chari, Marshall, Chris, Kitchen, Helen, Macey, Jake, Pegram, Hannah, Slagle, Ashley F., Gish, Robert G., Ning, Qin, Yatsuhashi, Hiroshi, Cornberg, Markus, Brunetto, Maurizia, van Bömmel, Florian, Xie, Qing, Lee, Dee, Habuka, Noriyuki, Sbarigia, Urbano, Beumont-Mauviel, Maria, Keever, Angelina Villasis

Source: BMC Public Health; 2/26/2024, Vol. 24 Issue 1, p1-14, 14p

Subject Terms: CHRONIC hepatitis B, QUALITY of life, SOCIAL stigma, HEPATITIS B, SOCIAL impact

An Updated Review of Food and Drug Administration Warning and Untitled Letters for Clinical Outcome Assessment Claims Between 2013 and 2021

Authors: Sams, Lara, Slagle, Ashley F., Symonds, Tara, Antonova, Jenya, Globe, Denise

Source: In Value in Health December 2023 26(12):1675-1680

Psychometric Validation and Meaningful Change Thresholds of the New Nasal Polyposis Symptom Diary.

Authors: Shih, Vivian H.¹ Vivian.Shih@AstraZeneca.com, Slagle, Ashley F.², Ivanescu, Cristina³, Flore, Giulio³, Meyers, Oren³, Kreindler, James¹, Martin, Ubaldo J.¹, Werkström, Viktoria¹

Source: Annals of Otology, Rhinology & Laryngology. Dec2023, Vol. 132 Issue 12, p1638-1648. 11p.

Subject Terms: *SINUSITIS treatment, *CHRONIC disease treatment, *NASAL polyps, *STATISTICS, *CONFIDENCE intervals, *RESEARCH methodology evaluation, *RESEARCH methodology, *HEALTH outcome assessment, *PSYCHOMETRICS, *SEVERITY of illness index, *T-test (Statistics), *RESEARCH funding, *DESCRIPTIVE statistics, *ANALYSIS of covariance, *DATA analysis software, *DATA analysis, *EVALUATION, RESEARCH evaluation

The value of co-creating a clinical outcome assessment strategy for clinical trial research: process and lessons learnt.

Authors: Morel, Thomas, Schroeder, Karlin, Cleanthous, Sophie, Andrejack, John, Blavat, Geraldine, Brooks, William, Gosden, Lesley, Siu, Carroll, Ratcliffe, Natasha, Slagle, Ashley F.

Source: Research Involvement & Engagement; 10/24/2023, Vol. 9 Issue 1, p1-14, 14p

Subject Terms: HEALTH outcome assessment, PARKINSON'S disease, MEDICAL research, PATIENT participation, PATIENT experience

Mo1184 AN EPISODE-BASED PATIENT-REPORTED OUTCOME MEASURE OF DYSPHAGIA EXPERIENCE IS FEASIBLE AND NOT BURDENSOME FOR PATIENTS WITH EOSINOPHILIC ESOPHAGITIS

Authors: Dellon, Evan S., Sparling, Nicole, Rohay, Jeffrey, Whitsett, Joy, Slagle, Ashley F., Eagle, Gina, Nezamis, James P., Richardson, Peter, Paty, Jean

Source: Gastroenterology. 158(6):S-818-S-818

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100131716458.0x000001&indx=1&recIds=ETOCvdc_100131716458.0x000001

Psychometric evaluation of the Symptoms of Infection with Coronavirus-19 (SIC): results from a cross-sectional study and a phase 3 clinical trial.

Authors: Chan, Eric K.H., Williams, Valerie, Romano, Carla, Fehnel, Sheri, Slagle, Ashley F., Stoddard, Jeffrey, Sadoff, Jerald, Mayorga, Margaret, Lewis, Sandy, Yarr, Stuart, Ma, Jia, Liu, Yan, Katz, Eva G., McNulty, Pauline, van Dromme, Ilse, McQuarrie, Kelly

Source: Journal of Patient-Reported Outcomes; 5/17/2023, Vol. 7 Issue 1, p1-12, 12p

Subject Terms: RESEARCH evaluation, STATISTICAL reliability, CROSS-sectional method, CORONAVIRUS diseases, HEALTH outcome assessment, EXIT interviewing, PSYCHOMETRICS, QUALITATIVE research, MULTITRAIT multimethod techniques, CRONBACH'S alpha, COUGH, INTRACLASS correlation, RESEARCH funding, DESCRIPTIVE statistics, FATIGUE (Physiology), LONGITUDINAL method, SYMPTOMS

Geographic Terms: UNITED States

Development and early qualitative evidence of two novel patient-reported outcome instruments to assess daily functioning in people with early-stage Parkinson's.

Authors: Morel, Thomas, Cleanthous, Sophie, Andrejack, John, Barker, Roger A., Biagioni, Milton, Blavat, Geraldine, Bloem, Bastiaan R., Boroojerdi, Babak, Brooks, William, Burns, Paul, Cano, Stefan, Gallagher, Casey, Gosden, Lesley, Siu, Carroll, Slagle, Ashley F., Ratcliffe, Natasha, Schroeder, Karlin

Source: Journal of Patient-Reported Outcomes; 4/20/2023, Vol. 7 Issue 1, p1-14, 14p

Subject Terms: EXPERIMENTAL design, FUNCTIONAL status, RESEARCH methodology, GAIT in humans, POSTURAL balance, MATHEMATICAL models, HEALTH outcome assessment, ACTIVITIES of daily living, INTERVIEWING, COGNITION, QUALITATIVE research, PHYSICAL mobility, PARKINSON'S disease, DIAGNOSIS, HEALTH care teams, THEORY, SCALE analysis (Psychology), RESEARCH funding, MOTOR ability

Policy implications of drug importation

Authors: Palumbo, Francis B. ^*, Mullins, C. Daniel, Slagle, Ashley F., Rizer, Jessica

Source: In Clinical Therapeutics 2007 29(12):2758-2767

Patient Experience in Early-Stage Parkinson's Disease: Using a Mixed Methods Analysis to Identify Which Concepts Are Cardinal for Clinical Trial Outcome Assessment.

Authors: Morel, Thomas, Cleanthous, Sophie, Andrejack, John, Barker, Roger A., Blavat, Geraldine, Brooks, William, Burns, Paul, Cano, Stefan, Gallagher, Casey, Gosden, Lesley, Siu, Carroll, Slagle, Ashley F., Trenam, Kate, Boroojerdi, Babak, Ratcliffe, Natasha, Schroeder, Karlin

Source: Neurology & Therapy; Sep2022, Vol. 11 Issue 3, p1319-1340, 22p

Subject Terms: PARKINSON'S disease, HEALTH outcome assessment, PATIENT experience, FINE motor ability, MOVEMENT disorders, MOTOR ability, TREMOR, APATHY, COMPLICATED grief

Development of a novel patient-reported outcome measure to assess signs and symptoms of COVID-19.

Authors: Romano, Carla, Fehnel, Sheri, Stoddard, Jeffrey, Sadoff, Jerald, Lewis, Sandy, McNulty, Pauline, Chan, Eric K. H., Evans, Emily, Jamieson, Carol, Slagle, Ashley F., Mangel, Allen, McQuarrie, Kelly

Source: Journal of Patient-Reported Outcomes; 7/29/2022, Vol. 6 Issue 1, p1-12, 12p

Subject Terms: EXPERIMENTAL design, CAREGIVER attitudes, COVID-19, RESEARCH methodology, ATTITUDES of medical personnel, HEALTH outcome assessment, INTERVIEWING, QUALITATIVE research, PATIENTS' attitudes, SEVERITY of illness index, VOLUNTEER service

Geographic Terms: UNITED States

WED-151 - Self-stigma in chronic hepatitis B: content and psychometric validation of a new patient-reported outcome instrument

Authors: Gish, Robert G., Toumi, Mondher, Wallace, Jack, Cohen, Chari, Wang, Su, Marshall, Chris, Kitchen, Helen, Macey, Jake, Pegram, Hannah, Houts, Carrie, Mangrum, Rikki, Slagle, Ashley F., Lazarus, Jeffrey, Kennedy, Patrick, van Bömmel, Florian, Brunetto, Maurizia, Ning, Qin, Yatsuhashi, Hiroshi, Cornberg, Markus, Xie, Qing, Lee, Dee, Keever, Angelina Villasis, Sbarigia, Urbano, Takahashi, Yasushi, Jerzorwski, John, Talloen, Willem, Biermer, Michael, Chan, Eric

Source: In Journal of Hepatology June 2023 78 Supplement 1:S1087-S1088

Development and content validation of a symptom assessment for eosinophilic gastritis and eosinophilic gastroenteritis in adults and adolescents.

Authors: Ho, Calvin N., O'Quinn, Sean, Bailey, Julie, Meyers, Oren, Slagle, Ashley F., Dellon, Evan S., Datto, Catherine

Source: Orphanet Journal of Rare Diseases; 11/24/2021, Vol. 16 Issue 1, p1-9, 9p

Subject Terms: ADULTS, TEENAGERS, GASTROENTERITIS, MEDICAL personnel, SYMPTOMS, TEENAGE girls, APPETITE

Correction to: The value of co-creating a clinical outcome assessment strategy for clinical trial research: process and lessons learnt.

Authors: Morel, Thomas, Schroeder, Karlin, Cleanthous, Sophie, Andrejack, John, Blavat, Geraldine, Brooks, William, Gosden, Lesley, Siu, Carroll, Ratcliffe, Natasha, Slagle, Ashley F.

Source: Research Involvement & Engagement; 1/9/2024, Vol. 10 Issue 1, p1-1, 1p

Subject Terms: HEALTH outcome assessment, CLINICAL trials, MEDICAL research, PATIENT experience

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