Browsing by Subject "patient-reported outcomes"

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    Associating persistent self-reported cognitive decline with neurocognitive decline in older breast cancer survivors using machine learning: The Thinking and Living with Cancer study
    (Elsevier, 2022-11) Van Dyk, Kathleen; Ahn, Jaeil; Zhou, Xingtao; Zhai, Wanting; Ahles, Tim A.; Bethea, Traci N.; Carroll, Judith E.; Cohen, Harvey Jay; Dilawari, Asma A.; Graham, Deena; Jacobsen, Paul B.; Jim, Heather; McDonald, Brenna C.; Nakamura, Zev M.; Patel, Sunita K.; Rentscher, Kelly E.; Saykin, Andrew J.; Small, Brent J.; Mandelblatt, Jeanne S.; Root, James C.; Radiology and Imaging Sciences, School of Medicine
    Introduction: Many cancer survivors report cognitive problems following diagnosis and treatment. However, the clinical significance of patient-reported cognitive symptoms early in survivorship can be unclear. We used a machine learning approach to determine the association of persistent self-reported cognitive symptoms two years after diagnosis and neurocognitive test performance in a prospective cohort of older breast cancer survivors. Materials and Methods: We enrolled breast cancer survivors with non-metastatic disease (n=435) and age- and education-matched non-cancer controls (n=441) between August 2010 and December 2017 and followed until January 2020; we excluded women with neurological disease and all women passed a cognitive screen at enrollment. Women completed the FACT-Cog Perceived Cognitive Impairment (PCI) scale and neurocognitive tests of attention, processing speed, executive function, learning, memory and visuospatial ability, and timed activities of daily living assessments at enrollment (pre-systemic treatment) and annually to 24 months, for a total of 59 individual neurocognitive measures. We defined persistent self-reported cognitive decline as clinically meaningful decline (3.7+ points) on the PCI scale from enrollment to twelve months with persistence to 24 months. Analysis used four machine learning models based on data for change scores (baseline to twelve months) on the 59 neurocognitive measures and measures of depression, anxiety, and fatigue to determine a set of variables that distinguished the 24-month persistent cognitive decline group from non-cancer controls or from survivors without decline. Results: The sample of survivors and controls ranged in age from were ages 60–89. Thirty-three percent of survivors had self-reported cognitive decline at twelve months and two-thirds continued to have persistent decline to 24 months (n=60). Least Absolute Shrinkage and Selection Operator (LASSO) models distinguished survivors with persistent self-reported declines from controls (AUC=0.736) and survivors without decline (n=147; AUC=0.744). The variables that separated groups were predominantly neurocognitive test performance change scores, including declines in list learning, verbal fluency, and attention measures. Discussion: Machine learning may be useful to further our understanding of cancer-related cognitive decline. Our results suggest that persistent self-reported cognitive problems among older women with breast cancer are associated with a constellation of mild neurocognitive changes warranting clinical attention.
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    Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS)
    (Elsevier, 2021) Ma, Christopher; Schoepfer, Alain M.; Dellon, Evan S.; Bredenoord, Albert J.; Chehade, Mirna; Collins, Margaret H.; Feagan, Brian G.; Furuta, Glenn T.; Gupta, Sandeep K.; Hirano, Ikuo; Jairath, Vipul; Katzka, David A.; Pai, Rish K.; Rothenberg, Marc E.; Straumann, Alex; Aceves, Seema S.; Alexander, Jeffrey A.; Arva, Nicoleta C.; Atkins, Dan; Biedermann, Luc; Blanchard, Carine; Cianferoni, Antonella; Ciriza de los Rios, Constanza; Clayton, Frederic; Davis, Carla M.; de Bortoli, Nicola; Dias, Jorge A.; Falk, Gary W.; Genta, Robert M.; Ghaffari, Gisoo; Gonsalves, Nirmala; Greuter, Thomas; Hopp, Russell; Hsu Blatman, Karen S.; Jensen, Elizabeth T.; Johnston, Doug; Kagalwalla, Amir F.; Larsson, Helen M.; Leung, John; Louis, Hubert; Masterson, Joanne C.; Menard-Katcher, Calies; Menard-Katcher, Paul A.; Moawad, Fouad J.; Muir, Amanda B.; Mukkada, Vincent A.; Penagini, Roberto; Pesek, Robert D.; Peterson, Kathryn; Putnam, Philip E.; Ravelli, Alberto; Savarino, Edoardo V.; Schlag, Christoph; Schreiner, Philipp; Simon, Dagmar; Smyrk, Thomas C.; Spergel, Jonathan M.; Taft, Tiffany H.; Terreehorst, Ingrid; Vanuytsel, Tim; Venter, Carina; Vieira, Mario C.; Vieth, Michael; Vlieg-Boerstra, Berber; von Arnim, Ulrike; Walker, Marjorie M.; Wechsler, Joshua B.; Woodland, Philip; Woosley, John T.; Yang, Guang-Yu; Zevit, Noam; Safroneeva, Ekaterina; Medicine, School of Medicine
    Background End points used to determine treatment efficacy in eosinophilic esophagitis (EoE) have evolved over time. With multiple novel therapies in development for EoE, harmonization of outcomes measures will facilitate evidence synthesis and appraisal when comparing different treatments. Objective We sought to develop a core outcome set (COS) for controlled and observational studies of pharmacologic and diet interventions in adult and pediatric patients with EoE. Methods Candidate outcomes were generated from systematic literature reviews and patient engagement interviews and surveys. Consensus was established using an iterative Delphi process, with items voted on using a 9-point Likert scale and with feedback from other participants to allow score refinement. Consensus meetings were held to ratify the outcome domains of importance and the core outcome measures. Stakeholders were recruited internationally and included adult and pediatric gastroenterologists, allergists, dieticians, pathologists, psychologists, researchers, and methodologists. Results The COS consists of 4 outcome domains for controlled and observational studies: histopathology, endoscopy, patient-reported symptoms, and EoE-specific quality of life. A total of 69 stakeholders (response rate 95.8%) prioritized 42 outcomes in a 2-round Delphi process, and the final ratification meeting generated consensus on 33 outcome measures. These included measurement of the peak eosinophil count, Eosinophilic Esophagitis Histology Scoring System, Eosinophilic Esophagitis Endoscopic Reference Score, and patient-reported measures of dysphagia and quality of life. Conclusions This interdisciplinary collaboration involving global stakeholders has produced a COS that can be applied to adult and pediatric studies of pharmacologic and diet therapies for EoE and will facilitate meaningful treatment comparisons and improve the quality of data synthesis.
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    Eosinophilic Esophagitis Symptom Scores Are High in Children Without Eosinophilic Disease
    (Wolters Kluwer, 2021-10) Bose, Paroma; Albright, Eric; Idrees, Muhammad T.; Perkins, Anthony; Sawyers, Cindy; Gupta, Sandeep K.; Hon, Emily C.; Biostatistics, School of Public Health
    Objectives: The Pediatric Eosinophilic Esophagitis (EoE) Symptom Score version 2 (PEESSv2.0) is an EoE-specific validated metric for disease monitoring, but its use has not been explored outside of EoE. Our aim was to determine if PEESSv2.0 scores differentiate between children with EoE and non-EoE esophageal dysfunction undergoing initial esophagogastroduodenoscopy (EGD). Methods: A prospective cohort study of pediatric subjects was conducted. Children ages 1–18 undergoing initial EGD for esophageal dysfunction were enrolled. Demographics, clinical history, and child self-report and parent-proxy report PEESSv2.0 symptom scores were collected at the time of EGD. Esophageal biopsies were reviewed, and EoE was defined as >15 eosinophils/high powered field (hpf) seen in any level of the esophagus. Non-EoE was defined as <15 eosinophils/hpf. Results: Seventy-one children were included in the study from 2015 to 2018 [59% (42/71) males; mean age 9.2 years; range 1–17 years]. Fifty-eight percent (41/71) met criteria for EoE, and 42% (30/71) were labeled non-EoE. Non-EoE children and their parents had higher/worse median PEESSv2.0 total scores than those with EoE [47.0 vs 28.0 (P = 0.001) and 40.5 vs 26.5 (P = 0.012), respectively]. Non-EoE children reported higher median GERD [9.0 vs 4.0 (P = 0.003)], nausea/vomiting [9.0 vs 4.0 (P = 0.003)], and pain [11.0 vs 6.0 (P = 0.001)] subdomain scores compared to those with EoE. PEESSv2.0 dysphagia subdomain scores (child and parent-proxy) did not differ between EoE and non-EoE groups [22.0 vs 15.0 (P = 0.184) and 18.5 vs 17.4 (P = 0.330), respectively]. Discussion: Total PEESSv2.0 scores were worse in non-EoE group compared to EoE group. Although PEESSv2.0 is validated for use in monitoring EoE therapy, it does not distinguish children with EoE from non-EoE esophageal dysfunction at the time of diagnostic EGD.
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    Phase I of the Detecting and Evaluating Childhood Anxiety and Depression Effectively in Subspecialties (DECADES) Study: Development of an Integrated Mental Health Care Model for Pediatric Gastroenterology
    (JMIR Publications, 2018) Hullmann, Stephanie E.; Keller, Stacy A.; Lynch, Dustin O.; Jenkins, Kelli; Moore, Courtney; Cockrum, Brandon; Wiehe, Sarah E.; Carroll, Aaron E.; Bennett Jr, William E.; Psychiatry, School of Medicine
    Background: Children with gastrointestinal symptoms have a very high rate of anxiety and depression. Rapid identification of comorbid anxiety and depression is essential for effective treatment of a wide variety of functional gastrointestinal disorders. Objective: The objective of our study was to determine patient and parent attitudes toward depression, anxiety, and mental health screening during gastroenterology (GI) visits and to determine patient and parent preferences for communication of results and referral to mental health providers after a positive screen. Methods: We augmented standard qualitative group session methods with patient-centered design methods to assess patient and parent preferences. We used a variety of specific design methods in these sessions, including card sorting, projective methods, experience mapping, and constructive methods. Results: Overall, 11 families (11 patients and 14 parents) participated in 2 group sessions. Overall, patients and their parents found integrated mental health care to be acceptable in the subspecialty setting. Patients’ primary concerns were for the privacy and confidentiality of their screening results. Patients and their parents emphasized the importance of mental health services not interfering with the GI visit and collaboration between the GI physician, psychologist, and primary care provider. Conclusions: Patients and their families are open to integrated mental health care in the pediatric subspecialty clinic. The next phase of the DECADES study will translate patient and parent preferences into an integrated mental health care system and test its efficacy in the pediatric GI office. [J Participat Med 2018;10(3):e10655]
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    Preparing for the spread of patient-reported outcome (PRO) data collection from primary care to community pharmacy: a mixed-methods study
    (Springer, 2022-03-14) Adeoye-Olatunde, Omolola A.; Curran, Geoffrey M.; Jaynes, Heather A.; Hillman, Lisa A.; Sangasubana, Nisaratana; Chewning, Betty A.; Kreling, David H.; Schommer, Jon C.; Murawski, Matthew M.; Perkins, Susan M.; Snyder, Margie E.; Biostatistics and Health Data Science, Richard M. Fairbanks School of Public Health
    Background Medication non-adherence is a significant public health problem. Patient-reported outcomes (PROs) offer a rich data source to facilitate resolution of medication non-adherence. PatientToc™ is an electronic PRO data collection software originally implemented at primary care practices in California, United States (US). Currently, the use of standardized PRO data collection systems in US community pharmacies is limited. Thus, we are conducting a two-phase evaluation of the spread and scale of PatientToc™ to US Midwestern community pharmacies. This report focuses on the first phase of the evaluation. The objective of this phase was to prepare for implementation of PatientToc™ in community pharmacies by conducting a pre-implementation developmental formative evaluation to (1) identify potential barriers, facilitators, and actionable recommendations to PatientToc™ implementation and (2) create a draft implementation toolkit. Methods Data collection consisted of demographics, observations, audio-recorded contextual inquiries, and semi-structured interviews with staff (e.g., primary care providers, pharmacists, pharmacy technicians) and patients during 1-day site visits to a purposive sample of (1) primary care practices currently using PatientToc™ and (2) community pharmacies in Indiana, Wisconsin, and Minnesota interested in the future use of PatientToc™. Post-visit site observation debriefs were also audio-recorded. Verbatim transcripts of all recordings were coded using deductive/inductive approaches and intra-/inter-site summaries were produced identifying potential barriers, facilitators, and actionable recommendations mapped to the Consolidated Framework for Implementation Research constructs. A stakeholder advisory panel engaged in an Evidence-Based Quality Improvement (EBQI) implementation process. This included “member checking” and prioritizing findings, and feedback on the adapted PatientToc™ application, implementation strategies, and accompanying toolkit for community pharmacy implementation. Results Two primary care practices, nine pharmacies, and 89 individuals participated. Eight major themes (four barriers and four facilitators) and 14 recommendations were identified. Throughout the four EBQI sessions, the panel (1) confirmed findings; (2) designated high priority recommendations: (a) explain PatientToc™ and its benefits clearly and simply to patients, (b) ensure patients can complete questionnaires within 10 min, and (c) provide hands-on training/resources for pharmacy teams; and (3) provided feedback on the adapted PatientToc™ application and finalized toolkit items for initial community pharmacy implementation. Conclusions Adoption of electronically captured PROs in community pharmacies is warranted. The implementation strategies systematically developed in this study can serve as a model for implementation of technology-driven health information patient care services, in the understudied context of community pharmacies.
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    Quality of life changes after lumbar decompression in patients with tandem spinal stenosis
    (Elsevier, 2019-09) Pennington, Zach; Alentado, Vincent J.; Lubelski, Daniel; Alvin, Matthew D.; Levin, Jay M.; Benzel, Edward C.; Mroz, Thomas E.; Neurological Surgery, School of Medicine
    Objective Tandem spinal stenosis (TSS) is a degenerative spinal condition characterized by spinal canal narrowing at 2 or more distinct spinal levels. It is an aging-related condition that is likely to increase as the population ages, but which remains poorly described in the literature. Here we sought to determine the impact of primary lumbar decompression on quality-of-life (QOL) outcomes in patients with symptomatic TSS. Patients and methods We retrospectively reviewed 803 patients with clinical and radiographic evidence of TSS treated between 2008 and 2014 with a minimum 2-year follow-up. The records of patients with clinical and radiographic evidence of concurrent cervical and lumbar stenosis were reviewed. Prospectively gathered QOL data, including the Pain Disability Questionnaire (PDQ), Patient Health Questionnaire-9 (PHQ-9), EuroQOL-5 Dimensions (EQ-5D), and Visual Analogue Scale (VAS) for low back pain, were assessed at the 6-month, 1-year, and 2-year follow-ups. Results Of 803 identified patients (mean age 66.2 years; 46.9% male), 19.6% underwent lumbar decompression only, 14.1% underwent cervical + lumbar decompression, and 66.4% underwent conservative management only. Baseline VAS scores were similar across all groups, but patients undergoing conservative management had better baseline QOL scores on all other measures. Both surgical cohorts experienced significant improvements in the VAS, PDQ, and EQ-5D at all time points; patients in the cervical + lumbar cohort also had significant improvement in the PHQ-9. Conservatively managed patients showed no significant improvement in QOL scores at any follow-up interval. Conclusion Lumbar decompression with or without cervical decompression improves low back pain and QOL outcomes in patients with TSS. The decision to prioritize lumbar decompression is therefore unlikely to adversely affect long-term quality-of-life improvements.