Long-Term Toxicity Monitoring via Electronic Patient-Reported Outcomes in Patients Receiving Chemotherapy

Basch, Ethan; Iasonos, Alexia; Barz, Allison; Culkin, A.; Kris, Mark G.; Artz, David; Fearn, Paul; Speakman, John; Farquhar, Rena; Scher, Howard I.; McCabe, Mary S.; Schrag, Deborah

doi:10.1200/jco.2007.11.2243

Cited by 179 publications

(208 citation statements)

References 18 publications

Supporting

Mentioning

200

Contrasting

Order By: Relevance

“…We identified possible ADEs from the Common Terminology Criteria for Adverse Events version 4.0 [22], and existing symptom and ADE checklists [3,13,18,[23][24][25][26][27][28][29]. Patient-reported data about ADEs from the Lareb Intensive Monitoring System of The Netherlands Pharmacovigilance Centre Lareb [30] were used to translate ADEs into lay-terms.…”

Section: Adverse Drug Event (Ade) Selection and Naming In Lay-termsmentioning

confidence: 99%

Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire

et al. 2013

View full text Add to dashboard Cite

Background Direct patient reporting of adverse drug events (ADEs) is relevant for the evaluation of drug safety. To collect such data in clinical trials and postmarketing studies, a valid questionnaire is needed that can measure all possible ADEs experienced by patients. Objective Our aim was to develop and test a generic questionnaire to identify ADEs and quantify their nature and causality as reported by patients. Methods We created a draft list of common ADEs in layterms, which were classified in body categories and mapped to the Medical Dictionary for Regulatory Activities (MedDRA Ò ) terminology. Questions about the nature and causality were derived from existing questionnaires and causality scales. Content validity was tested through cognitive debriefing, revising the questionnaire in an iterative process. Feasibility and reliability were assessed using a Web-based version of the questionnaire. Patients received the questionnaire twice. Feasibility was assessed by the reported time needed for completion and ease of use. Reliability was calculated using Cohen's kappa and proportion of positive agreement (PPA) on: (1) any ADE at patient level; (2) similar ADEs at MedDRA Ò System Organ Class level; and (3) the same ADE at ADE-specific level.Results In the development phase, 28 patients with type 2 diabetes or asthma/chronic obstructive pulmonary disease (COPD) participated. Questions and answer options were rephrased, layout was improved, and changes were made in the classification of ADEs. The final questionnaire consisted of 252 ADEs organized in 16 body categories, and included 14 questions per reported ADE. A total of 135 patients using a median of five different drugs completed the Web-based questionnaire twice. The median completion time was 15 min for patients not reporting any ADE, and 30 min for patients reporting at least one ADE. Three quarters of the patients found the questionnaire easy to use. Test-retest reliability was acceptable at patient level (j = 0.50, PPA 0.64) and at MedDRA Ò System Organ Class level (j = 0.52, PPA 0.54), but was low at ADEspecific level (j = 0.38, PPA 0.38). Conclusion We developed a generic patient-reported ADE questionnaire and confirmed its content validity. The questionnaire was feasible and reliable for reporting any ADE and similar ADEs at MedDRA Ò System Organ Class level. Additional work is, however, needed to reliably quantify specific ADEs reported by patients.

show abstract

Section: Adverse Drug Event (Ade) Selection and Naming In Lay-termsmentioning

confidence: 99%

Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire

et al. 2013

View full text Add to dashboard Cite

show abstract

“…This has been identified as a problem in other research whereby poor utilisation of symptom reporting was associated with a perception among the participants that the information was not being explicitly addressed by the clinicians (Basch et al, 2007). A prerequisite to patient utilisation of an intervention in clinical practice is the perception that the intervention is of interest or can be used by the clinicians involved in that patient's care.…”

Section: Utilisation Of Diarymentioning

confidence: 95%

“…This is not unusual when implementing a new tool into routine practice (Lecouturier et al, 2002) and a similar study that implemented electronic recording of symptoms at chemotherapy clinics found that the most common barrier to adherence was that staff failed to remind patients to use the system (Basch et al, 2007). Although both community and hospital staff were aware that this study was ongoing and that patients had diaries which they were encouraged to share with them, it was not stipulated that they should ask patients for their diary.…”

Section: Utilisation Of Diarymentioning

confidence: 99%

Feasibility of a standardised quality of life questionnaire in a weekly diary format for inoperable lung cancer patients

Mills¹,

Murray²,

Johnston³

et al. 2008

European Journal of Oncology Nursing

View full text Add to dashboard Cite

a b s t r a c tObjective: Previous studies testing quality of life assessment (QoL) in routine oncology clinical practice have been based at single institutions and many have utilised touch-screen computer technology. The objective of this study was to test the feasibility of a low-tech QoL diary that could be held by the patient and shared with professionals across the health care setting. Methods:The EORTC-QLQ-C30 and LC13 were used and adapted into an A5 diary format. Patients were instructed to complete the questions each week at home and to share the information with any health professional involved in their care. Feasibility of the diary format was examined through assessment of compliance, utilisation and satisfaction using a mixed methods approach.Results: Diary completion rates were good; however, utilisation of the diary was poor, with only 23% (13/57) of patients stating explicitly that they had shared the diary with a health professional. Patients were generally satisfied with the diary format; however, qualitative analysis did identify some negative effects of diary completion. Conclusions: A patient-held QoL diary is feasible for a proportion of palliative care patients but the importance of training and support for patients and staff cannot be underestimated when implementing a new tool into clinical practice.

show abstract

“…There are several advantages of ePRO, such as rapid access to data, a probable avoidance of errors during data entry, and fewer missing data in comparison with paperbased surveys and the capacity to trigger alerts or notifications for answers to special circumstances 3 and an improvement in patients' willingness to report sensitive information [23,28]. Although paperbased surveys of PRO still predominate because there are only a few reliable and validated ePRO questionnaires, numerous projects have evaluated feasibility and acceptance of HRQoL in ePRO measurement in the last few years [29][30][31][32][33][34]. Nevertheless, knowledge regarding patient acceptance, feasibility, and barriers remains limited [35], especially since hurdles might exist in relation to health status, technical skills, and socioeconomic aspects, which could influence both patients´ willingness to use ePRO and their response behavior [10,36,37].…”

Section: Electronic Measurement Of Patient-reported Outcomesmentioning

confidence: 99%

An Electronic Patient-Reported Outcome Tool for the FACT-B (Functional Assessment of Cancer Therapy-Breast) Questionnaire for Measuring the Health-Related Quality of Life in Patients With Breast Cancer: Reliability Study (Preprint)

Matthies¹,

Taran²,

Keilmann³

et al. 2018

Preprint

View full text Add to dashboard Cite

BackgroundThe most frequent malignant disease in women is breast cancer. In the metastatic setting, quality of life is the primary therapeutic goal and systematic treatment has only limited effect on survival rates; therefore, the concept of Health-related Quality of Life (HRQoL) and measurement of Patient Reported Outcomes (PRO) is gaining more and more importance in the therapy setting of diseases such as breast cancer. One of the frequently used questionnaires for measuring HRQoL in breast cancer patients is the Functional Assessment of Cancer Therapy -Breast (FACT-B). Currently, paperbased surveys still predominate as only a few reliable and validated electronic-based questionnaires are available. EPRO tools of the FACT-B questionnaire with proven reliability are missing so far.

show abstract

Long-Term Toxicity Monitoring via Electronic Patient-Reported Outcomes in Patients Receiving Chemotherapy

Cited by 179 publications

References 18 publications

Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire

Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire

Feasibility of a standardised quality of life questionnaire in a weekly diary format for inoperable lung cancer patients

An Electronic Patient-Reported Outcome Tool for the FACT-B (Functional Assessment of Cancer Therapy-Breast) Questionnaire for Measuring the Health-Related Quality of Life in Patients With Breast Cancer: Reliability Study (Preprint)

Contact Info

Product

Resources

About