Optimizing electronic capture of patient-reported outcome measures in oncology clinical trials: lessons learned from a qualitative study

2020 ◽  
Vol 9 (17) ◽  
pp. 1195-1204
Author(s):  
Florence D Mowlem ◽  
Brad Sanderson ◽  
Jill V Platko ◽  
Bill Byrom
Keyword(s):  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Lessons Learned ◽  
Structured Interviews ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
Anticancer Treatment ◽  
Fit For Purpose ◽  
The Impact ◽  
Electronic Implementation

Aim: To understand the impact of anticancer treatment on oncology patients’ ability to use electronic solutions for completing patient-reported outcomes (ePRO). Materials & methods: Semi-structured interviews were conducted with seven individuals who had experienced a cancer diagnosis and treatment. Results: Participants reported that the following would impact the ability to interact with an ePRO solution: peripheral neuropathy of the hands (4/7), fatigue and/or concentration and memory issues (6/7), where they are in a treatment cycle (5/7). Approaches to improve usability included: larger, well-spaced buttons to deal with finger numbness, the ability to pause a survey and complete at a later point and presenting the recall period with every question to reduce reliance on memory. Conclusion: Symptoms associated with cancers and anticancer treatments can impact the use of technologies. The recommendations for optimizing the electronic implementation of patient-reported outcome instruments in this population provides the potential to improve data quality in oncology trials and places patient needs at the forefront to ensure ‘fit-for-purpose’ solutions.

scholarly journals A systematic review of patient-reported outcome measures in paediatric otolaryngology

2017 ◽  
Vol 132 (1) ◽  
pp. 2-7 ◽  
Author(s):  
J Powell ◽  
S Powell ◽  
A Robson
Keyword(s):  
Outcome Measures ◽  
English Language ◽  
Health Assessment ◽  
Paediatric Population ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Specific Patient ◽  
Patient Reported ◽  
The Impact

AbstractBackground:Recently, there has been increased emphasis on the development and application of patient-reported outcome measures. This drive to assess the impact of illness or interventions, from the patient's perspective, has resulted in a greater number of available questionnaires. The importance of selecting an appropriate patient-reported outcome measure is specifically emphasised in the paediatric population. The literature on patient-reported outcome measures used in paediatric otolaryngology was reviewed.Methods:A comprehensive literature search was conducted using the databases Medline, Embase, Cumulative Index to Nursing and Allied Health Literature, and PsycInfo, using the terms: ‘health assessment questionnaire’, ‘structured questionnaire’, ‘questionnaire’, ‘patient reported outcome measures’, ‘PROM’, ‘quality of life’ or ‘survey’, and ‘children’ or ‘otolaryngology’. The search was limited to English-language articles published between 1996 and 2016.Results:The search yielded 656 articles, of which 63 were considered relevant. This included general paediatric patient-reported outcome measures applied to otolaryngology, and paediatric otolaryngology disease-specific patient-reported outcome measures.Conclusion:A large collection of patient-reported outcome measures are described in the paediatric otolaryngology literature. Greater standardisation of the patient-reported outcome measures used in paediatric otolaryngology would assist in pooling of data and increase the validation of tools used.

scholarly journals The impact of patient-reported outcome measures in clinical practice for pain: a systematic review

2016 ◽  
Vol 26 (2) ◽  
pp. 245-257 ◽  
Author(s):  
Michelle M. Holmes ◽  
George Lewith ◽  
David Newell ◽  
Jonathan Field ◽  
Felicity L. Bishop
Keyword(s):  
Systematic Review ◽  
Clinical Practice ◽  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
The Impact

scholarly journals Capturing the experiences of patients with inherited optic neuropathies: a systematic review of patient-reported outcome measures (PROMs) and qualitative studies

2022 ◽  
Author(s):  
Benson S. Chen ◽  
Tomasz Galus ◽  
Stephanie Archer ◽  
Valerija Tadić ◽  
Mike Horton ◽  
...  
Keyword(s):  
Systematic Review ◽  
Health Status ◽  
Outcome Measures ◽  
Vision Loss ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Qualitative Studies ◽  
Psychometric Performance ◽  
Patient Reported ◽  
The Impact

Abstract Purpose To identify and comprehensively evaluate studies capturing the experience of individuals affected by an inherited optic neuropathy (ION), focusing on patient-reported outcome measures (PROMs) and qualitative studies where the health status and quality of life (QoL) of these individuals have been explored. Methods Systematic review of five databases using a search strategy combining four concepts: (1) ION; (2) QoL and health status; (3) PROMs; and (4) qualitative research. Studies assessing the impact of ION on any QoL domain using a PROM or qualitative methodology were included and appraised, using criteria based on the COSMIN checklist (for PROM studies) and the CASP checklist (for qualitative studies). Results Of 1326 unique articles identified, six studies were included. Five PROMs were identified: Visual Function Index (VF-14); Hospital Anxiety and Depression Scale (HADS); a novel graphical online assessment tool (NGOAT) for reporting emotional response to vision loss; a new PROM informed by the DSM-V Criteria for Major Depressive Disorder; and an interpersonal and career ‘impact rating’ PROM. The psychometric performance of included PROMs were poorly described. Qualitative studies found that vision loss resulted in psychosocial losses including loss of social and communication skills and loss of independence and freedom. Factors that modified the response to vision loss were also identified. Conclusion The current PROMs used by individuals with ION have poor content coverage, primarily measuring activity limitation and emotional well-being, and insufficient reporting of psychometric performance. There is a need to develop a PROM for individuals ION to report their experiences of living with their condition.

scholarly journals Development and validation of Gaucher disease type 1 (GD1)-specific patient-reported outcome measures (PROMs) for clinical monitoring and for clinical trials

2022 ◽  
Vol 17 (1) ◽  
Author(s):  
Deborah Elstein ◽  
Nadia Belmatoug ◽  
Patrick Deegan ◽  
Özlem Göker-Alpan ◽  
Derralynn A. Hughes ◽  
...  
Keyword(s):  
Gaucher Disease ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Psychometric Validation ◽  
Specific Patient ◽  
Patient Reported ◽  
Test Retest Reliability ◽  
Development And Validation ◽  
The Impact

Abstract Background Disease-specific patient-reported outcome measures (PROMs) are fundamental to understanding the impact on, and expectations of, patients with genetic disorders, and can facilitate constructive and educated conversations about treatments and outcomes. However, generic PROMs may fail to capture disease-specific concerns. Here we report the development and validation of a Gaucher disease (GD)-specific PROM for patients with type 1 Gaucher disease (GD1) a lysosomal storage disorder characterized by hepatosplenomegaly, thrombocytopenia, anemia, bruising, bone disease, and fatigue. Results and discussion The questionnaire was initially developed with input from 85 patients or parents of patients with GD1 or GD3 in Israel. Owing to few participating patients with GD3, content validity was assessed for patients with GD1 only. Content validity of the revised questionnaire was assessed in 33 patients in the US, France, and Israel according to US Food and Drug Administration standards, with input from a panel of six GD experts and one patient advocate representative. Concept elicitation interviews explored patient experience of symptoms and treatments, and a cognitive debriefing exercise explored patients’ understanding and relevance of instructions, items, response scales, and recall period. Two versions of the questionnaire were subsequently developed: a 24-item version for routine monitoring in clinical practice (rmGD1-PROM), and a 17-item version for use in clinical trials (ctGD1-PROM). Psychometric validation of the ctGD1-PROM was assessed in 46 adult patients with GD1 and re-administered two weeks later to examine test–retest reliability. Findings from the psychometric validation study revealed excellent internal consistency and strong evidence of convergent validity of the ctGD1-PROM based on correlations with the 36-item Short Form Health Survey. Most items were found to show moderate, good, or excellent test–retest reliability. Conclusions Development of the ctGD1-PROM represents an important step forward for researchers measuring the impact of GD and its respective treatment.

scholarly journals N07 Patient reported outcome measures collected from patients using a digital tablet: early benefits

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S660-S661
Author(s):  
P Avery ◽  
K Blackmore ◽  
C Angel
Keyword(s):  
Disease Activity ◽  
Outcome Measures ◽  
Disease Activity Score ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Activity Score ◽  
Data Set ◽  
Patient Reported ◽  
The Impact ◽  
Digital Tablet

Abstract Background At a district general hospital (DGH) on the south coast of England the inflammatory bowel disease (IBD) nurse led service introduced an eHealth system in 2015 linked to the IBD registry but limited to access via a desktop limiting flexibility. In liaison with the IBD registry and the software developer the lead nurse instigated an upgrade to the system. This allows patients access both remotely and via a digital tablet in outpatients. Discussion is being had about the best way to collect patient reported outcome measures (PROMS) both for large data analyse and local patient benefit. This presentation of the first 3 months collection of the PROMS seeks to show the benefit of these data locally Methods PROMS were gathered from both Consultant and Nurse led clinics from July 2019 to the 22 October 2019. Patients were asked to fill in the IBD control PROM (this PROM forms part of the IBD registry Data set) on a tablet before entering the consultation room. Additionally a disease activity score either the Harvey Bradshaw Score (HBI) or the Simple Clinical Colitis activity index (SCCAI) is collected at the same time. These scores were then extracted from the system and evaluated using a descriptive data analysis approach. Results After Data cleansing 200 records are shown in Table 1 covering all disease sub-types. Fatigue was the most commonly reported complication of IBD in addition,126 patients who attended outpatients reported a wellness score of above 75 out of 100 isolating the wellness score from the PROM score allowed a comparison with the corresponding disease activity score in these patients and correlated in 95% of UC Patients and CD 84% (see Table 2). Conclusion Fatigue is a widely reported symptom of IBD as well as pain and anxiety or depression. These data confirm this trend but also present the first local population information for the IBD service at this DGH. When looking at the impact of these scores there is an opportunity to identify patients that may need medically optimising. The patients that remain could then be targeted with support services and a business case for counselling is now planned. In addition to this together with self-testing with IBDoc ® the PROMs and disease activity scores provide opportunity for remote management of some patients. These PROMs collected from patients using a tablet in outpatients at a DGH show promising value for service development.

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