scholarly journals Patient-Reported Outcomes in Online Communications on Statins, Memory, and Cognition: Qualitative Analysis Using Online Communities (Preprint)

2019 ◽  
Author(s):  
Farris Timimi ◽  
Sara Ray ◽  
Erik Jones ◽  
Lee Aase ◽  
Kathleen Hoffman
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Online Communities ◽  
Side Effect ◽  
Online Communication ◽  
Linguistic Analysis ◽  
Control Group ◽  
Patient Reported ◽  
Hands On ◽  
The Impact

BACKGROUND In drug development clinical trials, there is a need for balance between restricting variables by setting eligibility criteria and representing the broader patient population that may use a product once it is approved. Similarly, although recent policy initiatives focusing on the inclusion of historically underrepresented groups are being implemented, barriers still remain. These limitations of clinical trials may mask potential product benefits and side effects. To bridge these gaps, online communication in health communities may serve as an additional population signal for drug side effects. OBJECTIVE The aim of this study was to employ a nontraditional dataset to identify drug side-effect signals. The study was designed to apply both natural language processing (NLP) technology and hands-on linguistic analysis to a set of online posts from known statin users to (1) identify any underlying crossover between the use of statins and impairment of memory or cognition and (2) obtain patient lexicon in their descriptions of experiences with statin medications and memory changes. METHODS Researchers utilized user-generated content on Inspire, looking at over 11 million posts across Inspire. Posts were written by patients and caregivers belonging to a variety of communities on Inspire. After identifying these posts, researchers used NLP and hands-on linguistic analysis to draw and expand upon correlations among statin use, memory, and cognition. RESULTS NLP analysis of posts identified statistical correlations between statin users and the discussion of memory impairment, which were not observed in control groups. NLP found that, out of all members on Inspire, 3.1% had posted about memory or cognition. In a control group of those who had posted about TNF inhibitors, 6.2% had also posted about memory and cognition. In comparison, of all those who had posted about a statin medication, 22.6% (<italic>P</italic>&lt;.001) also posted about memory and cognition. Furthermore, linguistic analysis of a sample of posts provided themes and context to these statistical findings. By looking at posts from statin users about memory, four key themes were found and described in detail in the data: memory loss, aphasia, cognitive impairment, and emotional change. CONCLUSIONS Correlations from this study point to a need for further research on the impact of statins on memory and cognition. Furthermore, when using nontraditional datasets, such as online communities, NLP and linguistic methodologies broaden the population for identifying side-effect signals. For side effects such as those on memory and cognition, where self-reporting may be unreliable, these methods can provide another avenue to inform patients, providers, and the Food and Drug Administration.

scholarly journals Patient-Reported Outcomes in Online Communications on Statins, Memory, and Cognition: Qualitative Analysis Using Online Communities

10.2196/14809 ◽  
2019 ◽  
Vol 21 (11) ◽  
pp. e14809 ◽  
Author(s):  
Farris Timimi ◽  
Sara Ray ◽  
Erik Jones ◽  
Lee Aase ◽  
Kathleen Hoffman
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Online Communities ◽  
Side Effect ◽  
Online Communication ◽  
Linguistic Analysis ◽  
Control Group ◽  
Patient Reported ◽  
Hands On ◽  
The Impact

Background In drug development clinical trials, there is a need for balance between restricting variables by setting eligibility criteria and representing the broader patient population that may use a product once it is approved. Similarly, although recent policy initiatives focusing on the inclusion of historically underrepresented groups are being implemented, barriers still remain. These limitations of clinical trials may mask potential product benefits and side effects. To bridge these gaps, online communication in health communities may serve as an additional population signal for drug side effects. Objective The aim of this study was to employ a nontraditional dataset to identify drug side-effect signals. The study was designed to apply both natural language processing (NLP) technology and hands-on linguistic analysis to a set of online posts from known statin users to (1) identify any underlying crossover between the use of statins and impairment of memory or cognition and (2) obtain patient lexicon in their descriptions of experiences with statin medications and memory changes. Methods Researchers utilized user-generated content on Inspire, looking at over 11 million posts across Inspire. Posts were written by patients and caregivers belonging to a variety of communities on Inspire. After identifying these posts, researchers used NLP and hands-on linguistic analysis to draw and expand upon correlations among statin use, memory, and cognition. Results NLP analysis of posts identified statistical correlations between statin users and the discussion of memory impairment, which were not observed in control groups. NLP found that, out of all members on Inspire, 3.1% had posted about memory or cognition. In a control group of those who had posted about TNF inhibitors, 6.2% had also posted about memory and cognition. In comparison, of all those who had posted about a statin medication, 22.6% (P<.001) also posted about memory and cognition. Furthermore, linguistic analysis of a sample of posts provided themes and context to these statistical findings. By looking at posts from statin users about memory, four key themes were found and described in detail in the data: memory loss, aphasia, cognitive impairment, and emotional change. Conclusions Correlations from this study point to a need for further research on the impact of statins on memory and cognition. Furthermore, when using nontraditional datasets, such as online communities, NLP and linguistic methodologies broaden the population for identifying side-effect signals. For side effects such as those on memory and cognition, where self-reporting may be unreliable, these methods can provide another avenue to inform patients, providers, and the Food and Drug Administration.

scholarly journals Evaluating the use of the EORTC patient-reported outcome measures for improving inter-rater reliability of CTCAE ratings in a mixed population of cancer patients: study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Lisa M. Wintner ◽  
◽  
Johannes M. Giesinger ◽  
Monika Sztankay ◽  
Andrew Bottomley ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Adverse Event ◽  
Adverse Events ◽  
Controlled Trial ◽  
Control Group ◽  
Rater Reliability ◽  
Randomized Controlled ◽  
Patient Reported ◽  
The Impact

Abstract Background In oncology, detection and tracking of adverse events are of top priority and rely mostly on the Common Terminology Criteria for Adverse Events (CTCAE). Besides, clinical trials use as well patient-reported outcomes (PROs) to assess those adverse events, which are only accessible through patient self-reporting, such as fatigue, pain, and sleep disorders. Especially those issues that are not visible from the outside are often misinterpreted and underestimated by mere provider ratings. This trial aims at evaluating the impact of providing PRO data to providers on the accuracy of adverse event assessment in terms of inter-rater reliability of CTCAE ratings. Methods The trial uses a cross-sectional, unblinded, randomized controlled trial design with two trial arms and a single assessment time point. Eligible patients (aged 18 and above, any cancer diagnosis, currently under treatment, inpatient or day clinic setting, present symptom burden, no psychiatric or mental problems, written informed consent) complete an electronic version of the EORTC QLQ-C30 and 16 additional questions taken from the EORTC Item Library. PRO data is immediately processed and made available to CTCAE rating providers for conducting their ratings during the medical encounter. Patients are randomly assigned 1:1 to the intervention group (providers see PRO results on the same screen as the CTCAE rating) and the control group (no access to PRO data during the CTCAE rating). A superiority analysis will compare the inter-rater reliability (using intra-class correlation (ICC) coefficients) between the control and the intervention groups for each adverse event evaluated. Discussion The presented trial will demonstrate potential benefits of using PRO measures to improve the reliability of CTCAE ratings in cancer trials and the identification of adverse events. The new insights gained may lead to a new strategy for evaluating adverse events in clinical trials by combining patient and provider ratings. This might also have implications for daily clinical practice and cancer registries. Trial registration ClinicalTrials.gov NCT04066868. Registered on August 26, 2019. Competence Center for Clinical Trials of the Medical University of Innsbruck 20190513-2007. Registered on May 14, 2019. (version 6.0, March 18, 2019)

Exploration of baseline patient-reported side effect bother from cancer therapy

2020 ◽  
Vol 17 (3) ◽  
pp. 332-337
Author(s):  
Jessica K Roydhouse ◽  
Bellinda L King-Kallimanis ◽  
Pourab Roy ◽  
Chana Weinstock ◽  
Danielle Krol ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Cancer Therapy ◽  
Functional Assessment ◽  
Side Effect ◽  
Completion Rates ◽  
Single Item ◽  
Patient Reports ◽  
Investigational Agent ◽  
Patient Reported

Background: Patient reports of expected treatment side effects are increasingly collected as part of the assessment of patient experience in clinical trials. A global side effect item that is patient-reported has the potential to inform overall tolerability. Therefore, the aim of this study was to examine the completion and distribution of such a global single-item measure of side effect burden in five cancer clinical trials. Methods: Data from five trials from internal Food and Drug Administration databases that included the Functional Assessment of Cancer Therapy–General single-item measure of overall side effect burden (i.e. impact on degree of bother) were analyzed. Completion rates for the side effect bother item, items adjacent to this item, and two non-adjacent items on the Functional Assessment of Cancer Therapy–General that are related to health-related quality of life were calculated at the baseline assessment and at the 3-month assessment. To evaluate the distribution, the percentage of patients reporting high levels (quite a bit or very much bother) of side effect bother at baseline and 3 months was assessed. Results: Completion rates for all items were at least 80% regardless of time point or trial population. However, in three of the five trials, completion rates for the side effect bother item were lower at baseline compared to adjacent and non-adjacent items. This difference was not observed at 3 months. Up to 9.4% of patients reported high levels of side effect bother at baseline. Conclusion: Patients may enter trials already reporting some bother from side effects. This can make interpretation of results with respect to the investigational agent under study challenging. Patients may skip an item evaluating side effect bother at baseline, suggesting some difficulty with interpretation of what is being asked. Further study of the wording and utility of a baseline side effect bother assessment is warranted.

scholarly journals Quality of life in schizophrenic patients

2007 ◽  
Vol 9 (2) ◽  
pp. 215-226 ◽  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Depressive Symptoms ◽  
Side Effects ◽  
Mental Disorders ◽  
Side Effect ◽  
Antipsychotic Drugs ◽  
Schizophrenic Patients ◽  
The Impact

In the last decades, there has been increased interest in the field of quality of life in mental disorders in general, and particularly in schizophrenia. In addition, the appearance of the atypical antipsychotic drugs (amisulpride, aripiprazole, clozapine, olanzapine, quetiapine, risperidone, and ziprasidone) with different therapeutic and side-effect profiles, has promoted a greater interest in assessing the quality of life of schizophrenic patients. In this paper we will briefly summarize the difficulties in assessing quality of life in schizophrenic patients, as well as the results concerning their quality of life and the influence of psychopathology, especially negative and depressive symptoms, on it. We will also review data from recent clinical trials showing the impact ofantipsychotic treatments and their side effects upon quality of life.

Overview of the Patient Perspective at OMERACT 10 — Conceptualizing Methods for Developing Patient-Reported Outcomes

2011 ◽  
Vol 38 (8) ◽  
pp. 1699-1701 ◽  
Author(s):  
JOHN R. KIRWAN ◽  
PETER S. TUGWELL
Keyword(s):  
Clinical Trials ◽  
Experimental Work ◽  
Patient Reported Outcomes ◽  
Patient Perspective ◽  
Methodological Issues ◽  
Instrument Selection ◽  
Patient Reported ◽  
The Impact ◽  
Choice Of Instruments ◽  
The Way

This overview draws out the main conclusions from the 4 workshops focused on incorporating the patient perspective into outcome assessment at the 10th Outcome Measures in Rheumatology (OMERACT 10) conference. They raised methodological issues about the choice of outcome domains to include in clinical trials, the development or choice of instruments to measure these domains, and the way these instruments might capture the impact of a disease and its treatment. The need to develop a more rigorous conceptual model of quantifying the way conditions affect health, and the need to ensure patients are directly involved in the decisions about domains and instruments, emerged clearly. The OMERACT participants voted to develop guidelines for domain and instrument selection, and conceptual and experimental work will be brought forward to revise and upgrade the OMERACT Filter.

Abstract 242: Evaluating the Impact and Barriers to a Collaborative Physician-pharmacist Care Model to Control Hypertension in a Low-income Population

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Kerrilynn C Hennessey ◽  
Carolyn Hickman ◽  
Brianne Krawczyk ◽  
Michelle Opare ◽  
Leslie Churchwell ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Side Effects ◽  
Blood Pressure Control ◽  
Low Income ◽  
Health Workers ◽  
Pressure Control ◽  
Low Income Population ◽  
Early Results ◽  
Patient Reported ◽  
The Impact

Objectives: Physician-pharmacist collaborative practice models have emerged as an effective model for managing hypertension (HTN). We implemented this model in a low-income, hospital-based cardiology clinic and sought to identify programmatic features necessary to control HTN in this vulnerable population. Methods: Patients with persistently elevated blood pressure (>130/80) were referred by their primary cardiologist. Patients were excluded if they were pregnant, had acute kidney injury, or acute cardiovascular complaints including anginal chest pain, decompensated heart failure, or unstable arrhythmia. The initial pharmacist appointment occurred within 2 weeks of referral, with the goal of bi-weekly visits for 6 weeks or until blood pressure was controlled. Patients were prescribed home blood pressure cuffs and given specific instructions for home-based monitoring. Telehealth visits were made available to interested patients. During each encounter, pharmacists assessed response and side effects to medication, adherence, lifestyle behaviors, stressors, and social barriers to blood pressure control. Clinical management and barriers to HTN control were reviewed at standing weekly staff meetings that included cardiologists and pharmacists. Early results: Among 35 people referred, 22 patients attended at least one pharmacist visit. A total of 139 reminder or follow-up calls were made for these 22 patients. Among the first 35 referrals (mean age 58; 57% male; 65% African American or Latinx), 26% have documented substance use disorders, 34% have a mental health comorbidity, 20% were not taking their medications as prescribed on intake, and 17% had side effects from 2 or more prior antihypertensive medications. Medications adjustments were made in 21/43 patient visits (49% of visits). In 8/43 visits more than 1 medication change was made. The most common patient reported barriers to care include transportation (20%) and language barriers (11%). Discussion and Future Direction: Managing HTN in a low-income population requires attention to the social and contextual factors impacting blood pressure control. We plan to: 1) support the uptake of telehealth to address issues of transportation and access; 2) pilot blue-tooth connected blood pressure cuffs to facilitate home monitoring and management; and 3) partner with community health workers to assess best practices for capturing and addressing social determinants of health in the clinical setting.

Dare voce ai pazienti nella ricerca sulle malattie rare e sui famaci orfani / Giving patients a voice in the rare diseases and orphan drugs research

2018 ◽  
Vol 67 (1) ◽  
pp. 25-40
Author(s):  
Elena Mancini ◽  
Roberta Martina Zagarella
Keyword(s):  
Clinical Trials ◽  
Rare Diseases ◽  
Patient Reported Outcomes ◽  
Narrative Medicine ◽  
Orphan Drugs ◽  
New Drugs ◽  
Patient Centered ◽  
Patient Reported ◽  
Critical Issues ◽  
The Impact

L’articolo ha l’obiettivo di mettere in luce potenzialità e criticità dell’inclusione della prospettiva dei pazienti nella ricerca sulle malattie rare e sui farmaci orfani. A tal fine, nella prima parte, si propone un’analisi epistemologica dell’utilizzo dei racconti dell’esperienza individuale della malattia nella ricerca scientifica e nei trial clinici, facendo emergere, anche attraverso gli strumenti della medicina narrativa, le sfide teoriche e operative poste dall’inclusione della soggettività del paziente e del vissuto di malattia nonché l’importanza della valorizzazione della prospettiva del paziente, sia in generale sia nella ricerca sulle malattie rare e sui farmaci orfani. Nella seconda parte, il testo analizza in particolare il ruolo degli esiti riportati dai pazienti o Patient Reported Outcomes (PROs), misure per la valutazione complessiva della salute basate sulla prospettiva dei pazienti stessi, incentrandosi sulla sperimentazione clinica nel campo delle malattie rare. In questo contesto, infatti, i racconti di malattia, raccolti e valorizzati da fonti istituzionali e associazioni di pazienti, hanno contribuito a far emergere importanti questioni critiche e difficoltà nell’impiego di outcome centrati sul paziente nello sviluppo di nuovi farmaci e trattamenti, generando una serie di documenti e raccomandazioni relative al loro utilizzo per il benessere della comunità dei malati rari. ---------- This paper aims to highlight the potentiality and criticality of including patients’ perspective in rare diseases and orphan drugs research. In the first part, we propose an epistemological analysis of individual narrations of disease experience as they are used in scientific research and clinical trials. With the help of narrative medicine approach, this analysis points out theoretical and operational challenges of a perspective that includes patient’s subjectivity and illness experience. Furthermore, it reveals the significance of patients’ standpoints in general and in rare diseases as well as in the orphan drugs research. The second part of our article focuses on the role of the Patient reported Outcomes (PROs) – which are measures for the health’s overall assessment based on patient’s perspective – by investigating the impact on clinical trials for rare diseases. In this context, illness stories, which are collected and promoted by institutional sources and patients’ associations, contribute to underline important critical issues at stake in the employment of patient-centered outcomes both in new drugs and in the treatments development. Moreover, these stories are crucial to elaborate documents and recommendations concerning the use of PROs for the rare patients’ community welfare.

scholarly journals Patient-Reported Satisfaction Following Radiation of Implant-Based Breast Reconstruction

2019 ◽  
Vol 27 (2) ◽  
pp. 147-155 ◽  
Author(s):  
Eva Thiboutot ◽  
Peter Craighead ◽  
Carmen Webb ◽  
Claire Temple-Oberle
Keyword(s):  
Breast Reconstruction ◽  
Capsular Contracture ◽  
Control Group ◽  
Arm Morbidity ◽  
Patient Reported ◽  
Cosmetic Outcomes ◽  
Baseline Characteristics ◽  
Pro Tools ◽  
Tumour Characteristics ◽  
The Impact

Background: Little is known with regard to patient-reported outcomes (PROs) in the setting of implant-based reconstruction (IBR) with post-mastectomy radiation therapy (PMRT). Methods: We identified patients who underwent immediate IBR from a prospectively compiled database. The Breast Reconstruction Satisfaction Questionnaire (BRECON-31) was scored and compared between patients with and without PMRT. Results: Sixty-four women met the study criteria. Forty-eight did not receive PMRT and 16 did. Nine women had an unanticipated indication for PMRT. The PMRT group was similar to the control group with regard to baseline characteristics (ie, age, marital status, body mass index, tobacco use, and comorbidities). However, treatment and oncologic characteristics (eg, diagnosis, tumour characteristics, systemic therapy use) differed. Of all complications, only capsular contracture rates differed (1.2% vs 13%; P = .01). Of the 9 subscales, 7 showed no difference in satisfaction between the groups. Radiated women scored lower in the arm concerns and breast appearance subscales. Scores were similar whether the indication for PMRT had been anticipated or not. Discussion: Women with immediate IBR scored similarly to their nonradiated counterparts across 7 of 9 domains of satisfaction. Arm concerns and breast appearance scores are lower with PMRT, likely secondarily to more extensive nodal procedures in higher stage patients and to the side effect profile of radiotherapy. Our findings are in line with the few available studies using other PRO tools to evaluate the impact of PMRT on patient satisfaction and studies objectively measuring the effect of PMRT on arm morbidity and cosmetic outcomes.

scholarly journals The impact of patient-reported outcome (PRO) data from clinical trials: a systematic review and critical analysis

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Samantha Cruz Rivera ◽  
Derek G. Kyte ◽  
Olalekan Lee Aiyegbusi ◽  
Anita L. Slade ◽  
Christel McMullan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Case Studies ◽  
Real World ◽  
Clinical Trial Data ◽  
Research Impact ◽  
Trial Data ◽  
Patient Reported ◽  
The Impact

Abstract Background Patient-reported outcomes (PROs) are commonly collected in clinical trials and should provide impactful evidence on the effect of interventions on patient symptoms and quality of life. However, it is unclear how PRO impact is currently realised in practice. In addition, the different types of impact associated with PRO trial results, their barriers and facilitators, and appropriate impact metrics are not well defined. Therefore, our objectives were: i) to determine the range of potential impacts from PRO clinical trial data, ii) identify potential PRO impact metrics and iii) identify barriers/facilitators to maximising PRO impact; and iv) to examine real-world evidence of PRO trial data impact based on Research Excellence Framework (REF) impact case studies. Methods Two independent investigators searched MEDLINE, EMBASE, CINAHL+, HMIC databases from inception until December 2018. Articles were eligible if they discussed research impact in the context of PRO clinical trial data. In addition, the REF 2014 database was systematically searched. REF impact case studies were included if they incorporated PRO data in a clinical trial. Results Thirty-nine publications of eleven thousand four hundred eighty screened met the inclusion criteria. Nine types of PRO trial impact were identified; the most frequent of which centred around PRO data informing clinical decision-making. The included publications identified several barriers and facilitators around PRO trial design, conduct, analysis and report that can hinder or promote the impact of PRO trial data. Sixty-nine out of two hundred nine screened REF 2014 case studies were included. 12 (17%) REF case studies led to demonstrable impact including changes to international guidelines; national guidelines; influencing cost-effectiveness analysis; and influencing drug approvals. Conclusions PRO trial data may potentially lead to a range of benefits for patients and society, which can be measured through appropriate impact metrics. However, in practice there is relatively limited evidence demonstrating directly attributable and indirect real world PRO-related research impact. In part, this is due to the wider challenges of measuring the impact of research and PRO-specific issues around design, conduct, analysis and reporting. Adherence to guidelines and multi-stakeholder collaboration is essential to maximise the use of PRO trial data, facilitate impact and minimise research waste. Trial registration Systematic Review registration PROSPERO CRD42017067799.

The Impact of Prescribed Medication on Swallowing: An Overview

2010 ◽  
Vol 19 (4) ◽  
pp. 98-102 ◽  
Author(s):  
Louise Gallagher
Keyword(s):  
Side Effects ◽  
Best Practices ◽  
Side Effect ◽  
Team Member ◽  
Assessment Process ◽  
Valuable Resource ◽  
Speech Language Pathologists ◽  
Swallowing Difficulties ◽  
The Impact

Dysphagia clinicians are aware that best practices guidelines recommend a medications review as part of the assessment process. This article aims to review the literature to date regarding the impact that medications may have on the physiology of swallowing. It is important to consider the side effects of all medications, not only medications listing swallowing difficulties as a known side effect. Medications that impact upon arousal, awareness, and xerostomia should also be considered as part of a comprehensive dysphagia evaluation. Speech-language pathologists should consider the pharmacist an integral dysphagia team member and a valuable resource.

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