scholarly journals Using multiple imputation to deal with missing data and attrition in longitudinal studies with repeated measures of patient-reported outcomes

2015 ◽  
pp. 91 ◽  
Author(s):  
Karin Biering ◽  
Niels Henrik Hjollund ◽  
Morten Frydenberg
Keyword(s):  
Missing Data ◽  
Multiple Imputation ◽  
Longitudinal Studies ◽  
Repeated Measures ◽  
Patient Reported Outcomes ◽  
Patient Reported

scholarly journals Application of Machine Learning Algorithms to Depression Screening and Attempt at Pattern Extraction of Patient-Reported Outcomes that Negatively Affect Classification Accuracy (Preprint)

2017 ◽  
Author(s):  
Junetae Kim ◽  
Byungtae Lee ◽  
Sae Byul Lee ◽  
Il Yong Chung ◽  
Sei Hyun Ahn ◽  
...  
Keyword(s):  
Deep Learning ◽  
Missing Data ◽  
Patient Reported Outcomes ◽  
Machine Learning Algorithms ◽  
Depression Screening ◽  
Smartphone Applications ◽  
Patient Reported ◽  
Negative Effect ◽  
Using Data ◽  
Screening Accuracy

BACKGROUND Smartphone applications have recently been used as a breakthrough technology for monitoring mental health conditions in cancer outpatient settings. However, the use of electronic patient-reported outcomes (ePROs) on mental conditions through smartphone applications raises new concerns, which includes the question of the accuracy of depression screening. Thus, research is essential for improving the depression-screening performance. OBJECTIVE This study aims to (1) test whether deep-learning-based algorithms can overcome the limitations of traditional statistical methods in terms of depression screening accuracy. In addition, the study aims to (2) explore ePRO patterns that adversely affect depression screening accuracy. METHODS As a deep learning-based algorithm, a feedforward neural network algorithm was used. As a traditional statistical method, a random intercept logistic regression was employed. To explore the ePRO patterns that negatively impact model accuracy, mental fluctuations, missing data, and compounding effects between mental fluctuations and missing data were tested. The performances of the algorithms and the effects of the ePRO patterns were measured through the receiver operating characteristic comparison test. RESULTS The results of the study show that the performance of the deep-learning-based models was superior to that of the traditional statistical approach. The study found that mental fluctuations statistically reduced the accuracy of depression-screening models. A weak association between ePRO omissions and screening accuracy was found. Moreover, the compounding effects that had a negative effect on the depression screening accuracy were statistically significant. CONCLUSIONS Although well-trained deep-learning-based models exhibit excellent performance, they still have some limitations. Thus, it is very important to focus on data quality to predict health outcomes when using data that is difficult to quantify, such as mental conditions.

scholarly journals Impact of Medium Cut-Off Dialyzers on Patient-Reported Outcomes: COREXH Registry

2020 ◽  
pp. 1-9
Author(s):  
Juan Carlos Alarcon ◽  
Alfonso Bunch ◽  
Freddy Ardila ◽  
Eduardo Zuñiga ◽  
Jasmin I. Vesga ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Kidney Disease ◽  
Repeated Measures ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
High Flux ◽  
Middle Molecules ◽  
Patient Reported ◽  
The Impact

<b><i>Introduction:</i></b> A new generation of hemodialysis (HD) membranes called medium cut-off (MCO) membranes possesses enhanced capacities for middle molecule clearance, which have been associated with adverse outcomes in this population. These improvements could potentially positively impact patient-reported outcomes (PROs). <b><i>Objective:</i></b> The objective of this study was to evaluate the impact of MCO membranes on PROs in a cohort of HD patients in Colombia. <b><i>Methods:</i></b> This was a prospective, multicenter, observational cohort study of 992 patients from 12 renal clinics in Colombia who were switched from high-flux HD to MCO therapy and observed for 12 months. Changes in Kidney Disease Quality of Life 36-Item Short Form Survey (KDQoL-SF36) domains, Dialysis Symptom Index (DSI), and restless legs syndrome (RLS) 12 months after switching to MCO membranes were compared with time on high-flux membranes. Repeated measures of ANOVA were used to evaluate changes in KDQoL-SF36 scores; severity scoring was used to assess DSI changes over time; Cochran’s Q test was used to evaluate changes in frequency of diagnostic criteria of RLS. <b><i>Results:</i></b> During 12 months of follow-up, 3 of 5 KDQoL-SF36 domains improved compared with baseline: symptoms (<i>p</i> &#x3c; 0.0001), effects of kidney disease (<i>p</i> &#x3c; 0.0001), and burden of kidney disease (<i>p</i> &#x3c; 0.001). The proportion of patients diagnosed with RLS significantly decreased from 22.1% at baseline to 10% at 12 months (<i>p</i> &#x3c; 0.0001). No significant differences in the number of symptoms (DSI, <i>p =</i> 0.1) were observed, although their severity decreased (<i>p</i> = 0.009). <b><i>Conclusions:</i></b> In conventional HD patients, the expanded clearance of large middle molecules with MCO-HD membranes was associated with higher health-related quality of life scores and a decrease in the prevalence of RLS.

Integration of Electronic Patient-Reported Outcomes Into Routine Cancer Care: An Analysis of Factors Affecting Data Completeness

2017 ◽  
pp. 1-10 ◽  
Author(s):  
Nicholas G. Wysham ◽  
Steven P. Wolf ◽  
Gregory Samsa ◽  
Amy P. Abernethy ◽  
Thomas W. LeBlanc
Keyword(s):  
Missing Data ◽  
Patient Reported Outcomes ◽  
Health Care Systems ◽  
Clinical Care ◽  
Routine Care ◽  
Factors Affecting ◽  
Routine Clinical Care ◽  
Clinical Encounters ◽  
Patient Reported ◽  
Missing Items

Purpose Routinely collected patient-reported outcomes (PROs) could provide invaluable data to a patient-centered learning health system but are often highly missing in clinical trials. We analyzed our experience with PROs to understand patterns of missing data using electronic collection as part of routine clinical care. Methods This is an analysis of a prospectively collected observational database of electronic PROs captured as part of routine clinical care in four different outpatient oncology clinics at an academic referral center. Results More than 24,000 clinical encounters from 7,655 unique patients are included. Data were collected via an electronic tablet–based survey instrument (Patient Care Monitor, version 2.0), at the time of clinical care, as part of routine care processes. Missing instruments (ie, no items completed) were submitted for 6.8% of clinical encounters, and 15.8% of encounters had missing items. Nearly 90% of all encounters involved < 10% missing items. In multivariable analyses, younger age, private health insurance, being seen in the breast oncology clinic, less time spent on the instrument, and longitudinal care were significantly associated with less missingness. Conclusion Embedding collection of electronic PRO data into routine clinical care yielded low rates of missing data in this real-world, prospectively collected database. In contrast to clinical trial experience, missingness improve with longitudinal care. This approach may be a solution to minimizing missingness of PROs in research or clinical care settings in support of learning health care systems.

scholarly journals Patient-reported outcomes from the phase II FAST trial of zolbetuximab plus EOX compared to EOX alone as first-line treatment of patients with metastatic CLDN18.2+ gastroesophageal adenocarcinoma

2021 ◽  
Vol 24 (3) ◽  
pp. 721-730
Author(s):  
Florian Lordick ◽  
Salah-Eddin Al-Batran ◽  
Arijit Ganguli ◽  
Robert Morlock ◽  
Ugur Sahin ◽  
...  
Keyword(s):  
Disease Progression ◽  
Repeated Measures ◽  
Patient Reported Outcomes ◽  
Statistical Significance ◽  
Symptom Burden ◽  
Progression Free Survival ◽  
First Line ◽  
Patient Reported ◽  
Gastroesophageal Adenocarcinoma ◽  
Eortc Qlq

Abstract Background Zolbetuximab plus first-line EOX (epirubicin, oxaliplatin, capecitabine; ZOL/EOX) significantly prolonged progression-free survival and overall survival in the FAST trial vs EOX alone. We report the patient-reported outcomes (PROs) of FAST in patients with advanced gastroesophageal adenocarcinoma. Methods Patients were randomized to ZOL/EOX or EOX alone. Patients could receive ≤ 8 EOX cycles and remained on zolbetuximab until disease progression. PROs were collected using the EORTC QLQ-C30 and QLQ-STO22 before drug administration at day 1/cycle 1, day 1/cycle 5, end of EOX treatment, and q12w thereafter until disease progression. Time to deterioration (TTD), defined as the first meaningful worsening from baseline, in the individual QLQ-C30/QLQ-STO22 scores was analyzed. Longitudinal changes in scores from baseline were analyzed using a mixed-effects model for repeated measures (MMRM). Results The per protocol population included 143 (ZOL/EOX: 69; EOX: 74) patients. Baseline QLQ-C30 and STO22 scores were comparable between arms and denoted intermediate-to-high quality of life (QoL), intermediate-to-low global health status (GHS) and low symptom burden. Descriptive analyses showed no differences between arms until end of EOX but maintenance therapy with zolbetuximab was associated with better QoL and less symptom burden thereafter. TTD for most scores favored ZOL/EOX over EOX and reached statistical significance for GHS (p = 0.008). MMRM results support TTD findings; no statistically significant differences were observed between arms in any score except for nausea and vomiting (p = 0.0181 favoring EOX). Conclusions ZOL/EOX allowed patients to maintain good QoL and low symptom burden for longer than EOX alone.

scholarly journals Global sensitivity analysis of clinical trials with missing patient-reported outcomes

2018 ◽  
Vol 28 (5) ◽  
pp. 1439-1456 ◽  
Author(s):  
Daniel O Scharfstein ◽  
Aidan McDermott
Keyword(s):  
Sensitivity Analysis ◽  
Missing Data ◽  
Software Package ◽  
Patient Reported Outcomes ◽  
Randomized Trials ◽  
Global Sensitivity Analysis ◽  
Mandatory Reporting ◽  
Study Participation ◽  
Reporting Requirement ◽  
Patient Reported

Randomized trials with patient-reported outcomes are commonly plagued by missing data. The analysis of such trials relies on untestable assumptions about the missing data mechanism. To address this issue, it has been recommended that the sensitivity of the trial results to assumptions should be a mandatory reporting requirement. In this paper, we discuss a recently developed methodology (Scharfstein et al., Biometrics, 2018) for conducting sensitivity analysis of randomized trials in which outcomes are scheduled to be measured at fixed points in time after randomization and some subjects prematurely withdraw from study participation. The methodology is explicated in the context of a placebo-controlled randomized trial designed to evaluate a treatment for bipolar disorder. We present a comprehensive data analysis and a simulation study to evaluate the performance of the method. A software package entitled SAMON (R and SAS versions) that implements our methods is available at www.missingdatamatters.org .

Using patient-reported outcomes to assess the effectiveness of topical hormonal replacement therapy (THR) for vaginal complaints (VC) after anti-hormonal therapy (HT) treatment for breast cancer (BC).

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 77-77
Author(s):  
Omer HASSAN Jamy ◽  
Namratha Reddy Vontela ◽  
Justin Gatwood ◽  
Mark Stephen Walker ◽  
Edward J. Stepanski ◽  
...  
Keyword(s):  
Sexual Dysfunction ◽  
Repeated Measures ◽  
Patient Reported Outcomes ◽  
Early Stage ◽  
Cancer Center ◽  
Vaginal Dryness ◽  
Patient Reported ◽  
Symptom Scores ◽  
Previously Treated ◽  
The Impact

77 Background: THR is sometimes used for treatment of VC in BC patients previously treated with HT. The safety of this practice remains a question but the effectiveness of this strategy has not been reported. Methods: We conducted a retrospective analysis of patient reported symptoms at the West Cancer Center (WCC) between 2002 and 2014. Early stage BC patients previously treated with HT with reported VC ± THR were statistically matched 1:1 using propensity score matching with calipers of 0.01. Demographics and clinical characteristics were extracted from electronic records and a proprietary patient-reported outcomes database: the Patient Care Monitor (PCM). A baseline PCM score for vaginal dryness and sexual dysfunction was noted at the initiation of THR and was followed for 12 months. Univariate statistics compared the resulting cohorts and repeated measures ANOVA assessed the impact of topical therapy. Results: We compared 74 THR patients to 74 controls (Table). The mean reported symptom scores were 3 fold higher in the active group with no statistical improvement in symptom scores noted at 6 or 12 months (Table). At the WCC, of the 5,479 patients with VC analyzed, only 5% received THR. The study was underpowered for survival analysis. Conclusions: In our study, increased severity of VC was associated with increased use of THR. However, there is no evidence that THR was effective in alleviating symptoms of vaginal dryness or sexual dysfunction. [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document