scholarly journals Low Concordance of Patient-Reported Outcomes With Clinical and Clinical Trial Documentation

2018 ◽  
pp. 1-12 ◽  
Author(s):  
Charlene M. Fares ◽  
Timothy J. Williamson ◽  
Matthew K. Theisen ◽  
Amy Cummings ◽  
Krikor Bornazyan ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Gold Standard ◽  
Patient Reported Outcomes ◽  
Psychological Symptoms ◽  
Vital Signs ◽  
Symptom Assessment ◽  
Physical Symptoms ◽  
Albumin Concentration ◽  
Patient Reported

Purpose Health care research increasingly relies on assessment of data extracted from electronic medical records (EMRs). Clinical trial adverse event (AE) logs and patient-reported outcomes (PROs) are sources of data often available in the context of specific research projects. The aim of this study was to evaluate the extent of data concordance from these sources. Patients and Methods Patients enrolled in clinical trials or receiving standard treatment for lung cancer (n = 62) completed validated questionnaires on physical and psychological symptoms at up to three assessment points. Temporally matched documentation was extracted from EMR notes and, for clinical trial participants (n = 41), AE logs. Evaluated data included symptom assessment, vital signs, medication logs, and laboratory values. Agreement (positive, negative) and Cohen’s κ coefficients were calculated to assess concordance of symptoms among sources, with PROs considered the gold standard. Results Patient-reported weight loss correlated significantly with clinical measurements ( t = 2.90; P = .02), and average number of PROs correlated negatively with albumin concentration, supporting PROs as the gold standard. Comparisons of PROs versus EMR yielded poor concordance across 11 physical symptoms, anxiety, and depressive symptoms (all κ < 0.40). Providers under-reported the presence of each symptom in the EMR compared with PROs. AE logs showed similarly poor concordance with PROs (all κ < 0.40, except shortness of breath). Negative agreement among sources was higher than positive agreement for all symptoms except pain. Conclusion There was poor concordance between EMR notes and AE logs with PROs. Findings suggest that EMR notes and AE logs may not be reliable sources for capturing physical and psychological symptoms experienced by patients with lung cancer, supporting use of PRO assessments in oncology practices.

scholarly journals Use of a Cancer Registry to Evaluate Patient-Reported Outcomes of Immune Checkpoint Inhibitors

Cancers ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 103
Author(s):  
Heather S. L. Jim ◽  
Sarah L. Eisel ◽  
Aasha I. Hoogland ◽  
Sandra Shaw ◽  
Jennifer C. King ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Clinical Trial ◽  
Adverse Events ◽  
Cancer Registry ◽  
Patient Reported Outcomes ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Patient Reported

Immune checkpoint inhibitors (ICIs) are increasingly used for advanced lung cancer, but few studies have reported on patient-reported outcomes (PROs) outside the context of a clinical trial. The goal of the current study was to assess PROs in participants of a lung cancer registry who had been treated with an ICI. Patients participating in the GO2 Foundation’s Lung Cancer Registry who reported receiving atezolizumab, durvalumab, nivolumab, or pembrolizumab were invited to participate in a survey about their experiences during treatment. Quality of life was evaluated using the Functional Assessment of Cancer Therapy–General (FACT-G). Common symptomatic adverse events were evaluated using an item bank generated for ICIs. Internationally, 226 patients (mean age 61, 75% female) participated. Patients reported worse quality of life at the time of assessment than U.S. population and cancer normative samples. The most common moderate to severe adverse events during ICI treatment were fatigue (41%), aching joints (27%), and aching muscles (20%). Due to toxicity, 25% reported a treatment delay, 11% an emergency room visit, and 9% a hospitalization. This study is among the first to our knowledge to report on PROs of ICIs outside the context of a clinical trial. Results suggest higher rates of adverse events than previously reported in clinical trials.

scholarly journals Measuring patient-reported outcomes to improve cancer care in Canada: an analysis of provincial survey data

2018 ◽  
Vol 25 (2) ◽  
pp. 176 ◽  
Author(s):  
K. Tran ◽  
S. Zomer ◽  
J. Chadder ◽  
C. Earle ◽  
S. Fung ◽  
...  
Keyword(s):  
Cancer Treatment ◽  
Cancer Care ◽  
Patient Reported Outcomes ◽  
Symptom Burden ◽  
Symptom Assessment ◽  
Physical Symptoms ◽  
Assessment System ◽  
System Level ◽  
Care Providers ◽  
Patient Reported

Patient-reported outcomes measures (proms) are an important component of the shift from disease-centred to person-centred care. In oncology, proms describe the effects of cancer and its treatment from the patient perspective and ideally enable patients to communicate to their providers the physical symptoms and psychosocial concerns that are most relevant to them. The Edmonton Symptom Assessment System–revised (esas-r) is a commonly used and validated tool in Canada to assess symptoms related to cancer. Here, we describe the extent to which patient reported outcome programs have been implemented in Canada and the severity of symptoms causing distress for patients with cancer.As of April 2017, 8 of 10 provinces had implemented the esas-r to assess patient-reported outcomes. Data capture methods, the proportion of cancer treatment sites that have implemented the esas-r, and the time and frequency of screening vary from province to province. From October 2016 to March 2017 in the 8 reporting provinces, 88.0% of cancer patients were screened for symptoms. Of patients who reported having symptoms, 44.3% reported depression, with 15.5% reporting moderate-to-high levels; 50.0% reported pain, with 18.6% reporting moderate-to-high levels; 56.2% reported anxiety, with 20.4% reporting moderate-to-high levels; and 75.1% reported fatigue, with 34.4% reporting moderate-to-high levels.There are some notable areas in which the implementation of proms could be improved in Canada. Findings point to a need to increase the number of cancer treatment sites that screen all patients for symptoms; to standardize when and how frequently patients are screened across the country; to screen patients for symptoms during all phases of their cancer journey, not just during treatment; and to assess whether giving cancer care providers real-time patient-reported outcomes data has led to appropriate interventions that reduce the symptom burden and improve patient outcomes. Continued measurement and reporting at the system level will allow for a better understanding of progress in proms activity over time and of the areas in which targeted quality improvement efforts could ensure that patient symptoms and concerns are being addressed.

Comparison of a Novel Tazarotene 0.045% Lotion to Tazarotene 0.1% Cream: Patient-Reported Outcomes from a Phase 2 Clinical Trial

2019 ◽  
Vol 3 ◽  
pp. S9
Author(s):  
Zoe Draelos ◽  
Fran Cook-Bolden ◽  
Lawrence Green ◽  
Eric Guenin ◽  
Gina Martin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Patient Reported Outcomes ◽  
Phase 2 ◽  
Patient Reported ◽  
Phase 2 Clinical Trial

Abstract not available.

scholarly journals Longitudinal Analysis of Patient-Reported Outcomes in Clinical Trials: Applications of Multilevel and Multidimensional Item Response Theory

Psychometrika ◽  
2021 ◽  
Author(s):  
Li Cai ◽  
Carrie R. Houts
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Latent Variable ◽  
Patient Reported Outcomes ◽  
Multilevel Models ◽  
Latent Variable Models ◽  
Trial Data ◽  
Regulatory Science ◽  
Measurement Information ◽  
Patient Reported

AbstractWith decades of advance research and recent developments in the drug and medical device regulatory approval process, patient-reported outcomes (PROs) are becoming increasingly important in clinical trials. While clinical trial analyses typically treat scores from PROs as observed variables, the potential to use latent variable models when analyzing patient responses in clinical trial data presents novel opportunities for both psychometrics and regulatory science. An accessible overview of analyses commonly used to analyze longitudinal trial data and statistical models familiar in both psychometrics and biometrics, such as growth models, multilevel models, and latent variable models, is provided to call attention to connections and common themes among these models that have found use across many research areas. Additionally, examples using empirical data from a randomized clinical trial provide concrete demonstrations of the implementation of these models. The increasing availability of high-quality, psychometrically rigorous assessment instruments in clinical trials, of which the Patient-Reported Outcomes Measurement Information System (PROMIS®) is a prominent example, provides rare possibilities for psychometrics to help improve the statistical tools used in regulatory science.

scholarly journals P1.10-005 Generation of Symptom Burden Patient-Reported Outcomes for Patients with Lung Cancer

2017 ◽  
Vol 12 (11) ◽  
pp. S2024
Author(s):  
L. Williams ◽  
C. Cleeland ◽  
O. Bamidele ◽  
G. Simon
Keyword(s):  
Lung Cancer ◽  
Patient Reported Outcomes ◽  
Symptom Burden ◽  
Patient Reported
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