Systematic collection of patient reported outcome research data: A checklist for clinical research professionals

Wehrlen, Leslie; Krumlauf, Michael; Ness, Elizabeth; Maloof, Damiana; Bevans, Margaret

doi:10.1016/j.cct.2016.03.005

Cited by 14 publications

(11 citation statements)

References 50 publications

(166 reference statements)

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“…Members of the clinical study team should be trained to ensure PROs are properly administered and collected; detailed instructions should include their purpose and significance for the study [64]. Participating patients should receive clear instructions, and the importance of honest, independent, and complete responses should be conveyed [64]. The burden of PRO assessments could be reduced through electronic data collection instead of using paper questionnaires.…”

Section: Relevance and Limitations Of Pro Assessmentsmentioning

confidence: 99%

Patient-reported outcomes with nivolumab in advanced solid cancers

Tykodi

Schadendorf

Cella

et al. 2018

Cancer Treatment Reviews

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Patients with recurrent or metastatic cancer commonly suffer from debilitating toxicity associated with conventional treatment modalities, as well as disease-related symptoms, often with a concomitant negative impact on health-related quality of life (HRQoL). Patient-reported outcomes (PROs) provide important insights into the patient experience in clinical trials. Nivolumab is a programmed death-1 receptor inhibitor that extends survival in patients with recurrent or metastatic disease in multiple tumor types. In this review, we summarize published PRO analyses from eight phase II-IV clinical trials with nivolumab for the treatment of melanoma, non-small cell lung cancer, renal cell carcinoma (RCC), and squamous cell carcinoma of the head and neck (SCCHN). Symptom burden, physical functioning, and HRQoL were measured using generic, cancer-specific, and tumor type-specific validated PRO instruments. Nivolumab showed sustained stabilization across all tumor types and, in some cases, clinically meaningful improvement in HRQoL, whereas standard of care therapies often led to deteriorations. Exploratory analyses found a positive correlation between baseline HRQoL scores and overall survival in RCC, and between baseline HRQoL scores and healthcare resource utilization in SCCHN, suggesting that patient-reported symptoms at treatment initiation may have clinical value. In the era of value-based oncology care, stakeholders are increasingly interested in PRO findings to guide clinical, regulatory, and reimbursement decisions. However, missing data remain a significant challenge in PRO analyses, including in nivolumab trials. Future clinical trials in immuno-oncology should incorporate PRO data collection, including beyond treatment discontinuation or trial completion to assess the long-term effects of treatment on HRQoL.

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Section: Relevance and Limitations Of Pro Assessmentsmentioning

confidence: 99%

Patient-reported outcomes with nivolumab in advanced solid cancers

Tykodi

Schadendorf

Cella

et al. 2018

Cancer Treatment Reviews

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“…Several points regarding the administration and management of data have to be considered, for example, completion of data and management of missing data, accurate entry times, data confidentiality, information provided to subjects (including emergency contacts, study design) and long-term data storage (19). ItchApp © addressed all of these areas.…”

Section: Administration and Data Managementmentioning

confidence: 99%

ItchApp©: An App-based eDiary for Assessment of Chronic Pruritus in Clinical Trials

Gernart

Tsianakas²,

Zeidler³

et al. 2017

Acta Derm Venerol

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Performing a reliable assessment of chronic pruritus remains a challenge. Electronic diaries are often used, but many of the scales have not been validated. ItchApp© was developed for Android smartphones in order to address this lack. A total of 40 subjects with chronic pruritus completed questionnaires both on paper and with ItchApp© (verbal rating scale, numerical rating scale, dynamic pruritus score) in order to validate the software application. Strong correlations were found for test-retest reliability (intraclass correlation coefficient: 0.865-0.977) and convergent validity (Spearman's r: 0.442-0.924). A feasibility questionnaire for ItchApp© revealed a high level of user friendliness and compliance. This was confirmed in a randomized controlled trial with 68 subjects, for which the clinically important difference in the numerical rating scale values for ItchApp© was calculated (2.61 points). In summary, ItchApp© is a recently developed eDiary that can provide experts with a reliable evaluation of patients with chronic pruritus. It will be made available for future clinical trials.

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“…Patient reported outcome measures (PROMs), such as Quality of life (QoL) questionnaires, should ideally be systematically implemented in health care practices [ 12 ] as there seems to be a need for a more “holistic” approach within a modern view of health care. This calls for the inclusion of both disease-specific and generic QoL outcome measures [ 13 ].…”

Section: Introductionmentioning

confidence: 99%

Generic quality of life in persons with hearing loss: a systematic literature review

Nordvik

Heggdal

Brännström

et al. 2018

BMC Ear Nose Throat Disord

113

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BackgroundTo the best of our knowledge, no empirically based consensus has been reached as to if, and to what extent, persons with hearing loss (HL) have reduced generic Quality of life (QoL). There seems to be limited knowledge regarding to what extent a hearing aid (HA) would improve QoL. The main aim of the present study was to review studies about the relationship between HL and QoL. A supporting aim was to study the association between distress and HL.MethodsLiterature databases (Cinahl, Pub Med and Web of Science) were searched to identify relevant journal articles published in the period from January 2000 to March 17, 2016. We performed a primary search pertaining to the relationship between HL, HA and QoL (search number one) followed by a supporting search pertaining to the relationship between distress/mood/anxiety and HL (search number two). After checking for duplications and screening the titles of the papers, we read the abstracts of the remaining papers. The most relevant papers were read thoroughly, leaving us with the journal articles that met the inclusion criteria.ResultsTwenty journal articles were included in the present review: 13 were found in the primary search (HL and QoL), and seven in the supporting search (HL and distress). The literature yields equivocal findings regarding the association between generic QoL and HL. A strong association between distress and HL was shown, where distressed persons tend to have a lowered generic QoL. It is suggested that QoL is lowered among HL patients. Some studies suggest an increased generic QoL following the use of HA, especially during the first few months after initiation of treatment. Other studies suggest that HA use is one of several possible factors that contribute to improve generic QoL.ConclusionsThe majority of the studies suggest that HL is associated with reduced generic QoL. Using hearing aids seem to improve general QoL at follow-up within the first year. HL is a risk factor for distress. Further research is needed to explore the relationship between HL and generic QoL, in addition to the importance of influencing variables on this relationship.Electronic supplementary materialThe online version of this article (10.1186/s12901-018-0051-6) contains supplementary material, which is available to authorized users.

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Systematic collection of patient reported outcome research data: A checklist for clinical research professionals

Cited by 14 publications

References 50 publications

Patient-reported outcomes with nivolumab in advanced solid cancers

Patient-reported outcomes with nivolumab in advanced solid cancers

ItchApp©: An App-based eDiary for Assessment of Chronic Pruritus in Clinical Trials

Generic quality of life in persons with hearing loss: a systematic literature review

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