scholarly journals Integrating Electronic Patient-Reported Outcome Measures into Routine HIV Care and the ANRS CO3 Aquitaine Cohort�s Data Capture and Visualization System (QuAliV): Protocol for a Formative Research Study (Preprint)

2017 ◽  
Author(s):  
Diana Barger ◽  
Olivier Leleux ◽  
Valérie Conte ◽  
Vincent Sapparrart ◽  
Marie Gapillout ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Patient Reported Outcomes ◽  
Patient Reported Outcome ◽  
Hiv Care ◽  
People Living With Hiv ◽  
Web Based ◽  
Visualization System ◽  
Patient Reported ◽  
Living With Hiv

BACKGROUND Effective antiretroviral therapy has greatly reduced HIV-related morbidity and mortality, dramatically changing the demographics of the population of people living with HIV. The majority of people living with HIV in France are well cared for insofar as their HIV infection is concerned but remain at risk for age-associated comorbidities. Their long-term, potentially complex, and growing care needs make the routine, longitudinal assessment of health-related quality of life and other patient-reported outcomes of relevance in the current treatment era. OBJECTIVE We aim to describe the development of a Web-based electronic patient-reported outcomes system for people living with HIV linked to the ANRS CO3 Aquitaine cohort’s data capture and visualization system (ARPEGE) and designed to facilitate the electronic collection of patient-reported data and ultimately promote better patient-physician communication and quality of care (both patient satisfaction and health outcomes). METHODS Participants who meet the eligibility criteria will be invited to engage with the Web-based electronic patient-reported outcomes system and provided with the information necessary to create a personal patient account. They will then be able to access the electronic patient-reported outcomes system and complete a set of standardized validated questionnaires covering health-related quality of life (World Health Organization's Quality of Life Instrument in HIV infection, named WHOQOL-HIV BREF) and other patient-reported outcomes. The information provided via questionnaires will ultimately be presented in a summary format for clinicians, together with the patient’s HIV care history. RESULTS The prototype of the Web-based electronic patient-reported outcome system will be finalized and the first 2 formative research phases of the study (prototyping and usability testing) will be conducted from December 2017 to May 2018. We describe the sequential processes planned to ensure that the proposed electronic patient-reported outcome system is ready for formal pilot testing, referred to herein as phases 1a and 1b. We also describe the planned pilot-testing designed to evaluate the acceptability and use of the system from the patient’s perspective (phase 2). CONCLUSIONS As the underlying information technology solution, ARPEGE, has being developed in-house, should the feasibility study presented here yield promising results, the panel of services provided via the proposed portal could ultimately be expanded and used to experiment with health-promoting interventions in aging people living with HIV in hospital-based care or adapted for use in other patient populations. CLINICALTRIAL ClinicalTrials.gov NCT03296202; https://clinicaltrials.gov/ct2/show/NCT03296202 (Archived by WebCite at http://www.webcitation.org/6zgOBArps) REGISTERED REPORT IDENTIFIER RR1-10.2196/9439

scholarly journals Usability testing of a Web-based solution for the collection of electronic patient-reported outcomes in people living with HIV in Nouvelle Aquitaine, France (Preprint)

2019 ◽  
Author(s):  
Diana Barger ◽  
Olivier Leleux ◽  
Valérie Conte ◽  
Vincent Sapparrart ◽  
Marie Gapillout ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Usability Testing ◽  
Target Population ◽  
Ease Of Use ◽  
Hiv Care ◽  
People Living With Hiv ◽  
Web Based ◽  
Visualization System ◽  
Patient Reported ◽  
Living With Hiv

BACKGROUND Collecting patient-reported outcomes can be of great value for both research and chronic diseases management. We endeavoured to develop a new facet of the ANRS CO3 Aquitaine cohort study’s web-based data capture and visualization system (APPEGE ® 2.0) for the collection of electronic patient-reported outcomes in people living with HIV care for in Aquitaine, France. OBJECTIVE Given the novelty of the proposed data collection method for our setting and specific characteristics of the target population, we sought to evaluate the initial usability of a prototype of an electronic patient-reported outcomes (ePRO) information system (ARPEGE® 2.0). METHODS Two successive rounds of empirical, task-based, usability testing were conducted, involving eight “experts” and then six people living with HIV. Evaluators provided written feedback during round 1 and oral feedback during round 2. Evaluators who completed the full set of tasks responded to the Systems Usability Scale. We assessed changes in SUS scores between rounds and concluded usability testing when SUS scores reached a ceiling effect, defining “good” usability a priori as a usability score of 70. RESULTS Insights were generated regarding the visibility of system status and the match between the system and the real world that improved the solution’s usability markedly. Experts reported mean SUS scores of 65 +- 18.87 and patients reported mean SUS scores of 85 +- 5.4 (p=0.032). CONCLUSIONS Software modifications, informed by successive rounds of usability testing, resulted in sufficient gains in usability to undertake piloting. Usability testing also prompted us to find the appropriate balance between optimal security and ease of use. CLINICALTRIAL https://clinicaltrials.gov/ct2/show/NCT03296202 (Archived by WebCite at http://www.webcitation.org/6zgOBArps)

scholarly journals Characteristics and patient-reported outcomes associated to dropout in severely affected oncological patients

2021 ◽  
Author(s):  
Pimrapat Gebert ◽  
Daniel Schindel ◽  
Johann Frick ◽  
Liane Schenk ◽  
Ulrike Grittner
Keyword(s):  
Quality Of Life ◽  
Social Support ◽  
Cancer Patients ◽  
Patient Reported Outcomes ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Poor Quality ◽  
Drop Out ◽  
Patient Reported

Abstract BackgroundPatient-reported outcome measures (PROMs) are commonly used and are surrogates for clinical outcomes in cancer research. In the research setting of very severe diseases such as cancer, it is difficult to avoid the problem of incomplete questionnaires from drop-out or missing data due to patients who deceased during observation period. We aimed to explore patient characteristics and patient-reported outcomes associated with the time-to-dropout. MethodsIn the Oncological Social Care Project (OSCAR) study the condition of participants was assessed four times within 12 months (t0: baseline, t1: 3 months, t2: 6 months, and t3: 12 months) by validated PROMs. We performed competing-risks regression based on Fine and Gray’s proportional sub-distribution hazards model for exploring factors associated with time-to-dropout. Death was considered as competing risk. ResultsThree hundred sixty-two participants were analyzed in the study. 193 (53.3%) completed follow-up at 12 months, 67 (18.5%) patients dropped out, and 102 patients (28.2%) died during the study period. Poor subjective social support was related to higher risk for drop-out (SHR=2.10; 95%CI: 1.01 – 4.35). Lower values in health-related quality of life were related to drop-out and death. The subscales global health status/QoL, role functioning, physical functioning, and fatigue symptom in the EORTC QLQ-C30 were key characteristics associated with early drop-out.ConclusionSeverely affected cancer patients with poor social support and poor quality of life seem more likely to drop out of studies compared to patients with higher levels of social support and quality of life. This should be considered when planning studies assessing cancer patients. Methods to monitor drop-outs timely and handle missing outcomes might be used. Results of such studies have to be interpreted with caution in light of the particular drop-out mechanisms.

scholarly journals Web-Based Module for the Collection of Electronic Patient-Reported Outcomes in People Living With HIV in Nouvelle Aquitaine, France: Usability Evaluation

10.2196/15013 ◽  
2019 ◽  
Vol 3 (4) ◽  
pp. e15013 ◽  
Author(s):  
Diana Barger ◽  
Olivier Leleux ◽  
Valérie Conte ◽  
Vincent Sapparrart ◽  
Marie Gapillout ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Usability Testing ◽  
Target Population ◽  
Ease Of Use ◽  
People Living With Hiv ◽  
Research Staff ◽  
Web Based ◽  
System Usability Scale ◽  
Patient Reported ◽  
Living With Hiv

Background Patient-reported outcomes (PROs) can be of great value for both research and chronic disease management. We developed a new module of the ANRS CO3 Aquitaine cohort study’s Web-based data capture and visualization solution (APPEGE 2.0) for the collection of electronic PROs among people living with HIV cared for in Nouvelle Aquitaine, France. Objective This study aimed to evaluate the usability of 2 successively developed prototypes of ARPEGE 2.0’s electronic PROs module before launching a pilot study, owing to the novelty of the proposed data collection method for our setting and specific characteristics of the target population. Methods A total of 2 sequential rounds of empirical, task-based usability evaluations were conducted, involving 8 research staff and then 7 people living with HIV. Evaluators provided written feedback during round 1 and oral feedback during round 2. Evaluators who completed the full set of tasks responded to the System Usability Scale (SUS). We assessed changes in SUS scores between rounds and concluded usability testing when SUS scores reached a ceiling effect, defining good usability a priori as a usability score of 70. Results Insights were generated regarding the visibility of system status and the match between the system and the real world that improved the module’s usability. Research staff evaluators reported mean SUS scores of 65 (SD 18.87) and patient evaluators reported mean SUS scores of 85 (SD 5.4; P=.032). Conclusions Software modifications, informed by successive rounds of usability testing, resulted in sufficient gains in usability to undertake piloting. Insights generated during evaluations prompted us to find the appropriate balance between optimal security and ease of use. Trial Registration ClinicalTrials.gov NCT03296202; https://clinicaltrials.gov/ct2/show/NCT03296202 International Registered Report Identifier (IRRID) RR2-10.2196/10.2196/resprot.9439

scholarly journals Characteristics and Patient-reported Outcomes Associated to Dropout in Severely Affected Oncological Patients

2020 ◽  
Author(s):  
Pimrapat Gebert ◽  
Daniel Schindel ◽  
Johann Frick ◽  
Liane Schenk ◽  
Ulrike Grittner
Keyword(s):  
Quality Of Life ◽  
Social Support ◽  
Cancer Patients ◽  
Outcome Measures ◽  
Patient Reported Outcomes ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Drop Out ◽  
Patient Reported

Abstract BackgroundPatient-reported outcome measures are commonly used and are surrogates for clinical outcomes in cancer research. In the research setting of very severe diseases such as cancer, it is difficult to avoid the problem of incomplete questionnaires from drop-out or missing data due to patients who deceased during observation period. We aimed to explore patient characteristics and patient-reported outcomes associated with the time-to-dropout. MethodsIn the Oncological Social Care Project (OSCAR) study the condition of participants was assessed four times within 12 months (t0: baseline, t1: 3 months, t2: 6 months, t3:12 months) by validated patient-reported outcome measures. We performed competing-risks regression based on Fine and Gray’s proportional sub-distribution hazards model for exploring factors associated with time-to-dropout. Death was considered a competing risk. ResultsThree hundred sixty-two participants were analyzed in the study. 193 (53.3%) completed follow-up at 12 months, 67 (18.5%) patients dropped out, and 102 patients (28.2%) died during the study period. Poor subjective social support was related to higher risk for drop-out (SHR=2.10; 95%CI: 1.01 – 4.35). Lower values in quality of life (EORTC QLQ-C30) were related to drop-out and death. The subscales global health status/QoL, role functioning, physical functioning, and fatigue symptom were key characteristics associated with drop-out.ConclusionSeverely affected cancer patients with poor social support and poor quality of life seem more likely to drop out of studies compared to patients with higher levels of social support and quality of life. This should be considered when planning studies assessing cancer patients. Methods to monitor drop-outs timely and handle missing outcomes might be used. Results of such studies have to be interpreted with caution in light of the particular drop-out mechanisms.

Patient-reported outcome measures in psoriatic arthritis

2018 ◽  
Author(s):  
Laure Gossec ◽  
Tania Gudu ◽  
Maarten de Wit
Keyword(s):  
Quality Of Life ◽  
Psoriatic Arthritis ◽  
Patient Reported Outcomes ◽  
Severe Disease ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Point Of View ◽  
Patient Reported ◽  
The Impact

Psoriatic arthritis (PsA) is a chronic, potentially severe disease with an important impact on the lives of people who have this disease. The impact of PsA is wide-reaching, and both physical but also mental aspects of quality of life can be modified by this disease. Thus, the measurement of the patient’s status rests in part, on the assessment of patient-reported outcomes, i.e. questionnaires to assess different aspects of life. In the present chapter, we will discuss the impact of the disease from a qualitative point of view, and review different patient-reported questionnaires which are either specific to PsA, or generic, and which are used to assess people with PsA.

scholarly journals Quality of life as patient-reported outcomes: principles of assessment

2014 ◽  
Vol 16 (2) ◽  
pp. 137-145 ◽  
Keyword(s):  
Quality Of Life ◽  
Instrument Development ◽  
Patient Reported Outcomes ◽  
Patient Reported Outcome ◽  
Services Research ◽  
Patient Reported ◽  
Adult Psychiatry ◽  
Patient Groups ◽  
Made In

Assessing quality of life (QoL) as a patient-reported outcome in adult psychiatry poses challenges in terms of concepts, methods, and applications in research and practice. This review will outline conceptually the construct of QoL, its dimensionality, and its representation across patient groups. Methodological challenges are examined, along with principles of QoL instrument development and testing, as well as across cultures. Application of instruments in epidemiological, clinical health economics, and health services research is reviewed based on pertinent literature. Validated measures for depression, psychosis, and anxiety disorders are available in adult psychiatry, and are increasingly used in research. Still, targeted measures are lacking for many mental health conditions and only rarely are tools applied in the practice context. Progress has been made in the development of instruments that are now ready for implementation. The information to be gained is valuable for identifying patient-reported needs for and benefits of treatment.

scholarly journals Characteristics and Patient-reported Outcomes Associated to Dropout in Severely Affected Oncological Patients

2021 ◽  
Author(s):  
Pimrapat Gebert ◽  
Daniel Schindel ◽  
Johann Frick ◽  
Liane Schenk ◽  
Ulrike Grittner
Keyword(s):  
Quality Of Life ◽  
Social Support ◽  
Cancer Patients ◽  
Patient Reported Outcomes ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Poor Quality ◽  
Drop Out ◽  
Patient Reported

Abstract BackgroundPatient-reported outcome measures (PROMs) are commonly used and are surrogates for clinical outcomes in cancer research. In the research setting of very severe diseases such as cancer, it is difficult to avoid the problem of incomplete questionnaires from drop-out or missing data due to patients who deceased during observation period. We aimed to explore patient characteristics and patient-reported outcomes associated with the time-to-dropout. MethodsIn the Oncological Social Care Project (OSCAR) study the condition of participants was assessed four times within 12 months (t0: baseline, t1: 3 months, t2: 6 months, and t3: 12 months) by validated PROMs. We performed competing-risks regression based on Fine and Gray’s proportional sub-distribution hazards model for exploring factors associated with time-to-dropout. Death was considered as competing risk. ResultsThree hundred sixty-two participants were analyzed in the study. 193 (53.3%) completed follow-up at 12 months, 67 (18.5%) patients dropped out, and 102 patients (28.2%) died during the study period. Poor subjective social support was related to higher risk for drop-out (SHR=2.10; 95%CI: 1.01 – 4.35). Lower values in health-related quality of life were related to drop-out and death. The subscales global health status/QoL, role functioning, physical functioning, and fatigue symptom in the EORTC QLQ-C30 were key characteristics associated with early drop-out.ConclusionSeverely affected cancer patients with poor social support and poor quality of life seem more likely to drop out of studies compared to patients with higher levels of social support and quality of life. This should be considered when planning studies assessing cancer patients. Methods to monitor drop-outs timely and handle missing outcomes might be used. Results of such studies have to be interpreted with caution in light of the particular drop-out mechanisms.

scholarly journals Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials

2018 ◽  
Vol 15 (6) ◽  
pp. 624-630 ◽  
Author(s):  
Andrew Bottomley ◽  
Madeline Pe ◽  
Jeff Sloan ◽  
Ethan Basch ◽  
Franck Bonnetain ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Patient Reported Outcome ◽  
Outcome Data ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
Guidelines And Recommendations

Background There is currently a lack of consensus on how health-related quality of life and other patient-reported outcome measures in cancer randomized clinical trials are analyzed and interpreted. This makes it difficult to compare results across randomized controlled trials (RCTs) synthesize scientific research, and use that evidence to inform product labeling, clinical guidelines, and health policy. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data for Cancer Clinical Trials (SISAQOL) Consortium aims to develop guidelines and recommendations to standardize analyses of patient-reported outcome data in cancer RCTs. Methods and Results Members from the SISAQOL Consortium met in January 2017 to discuss relevant issues. Data from systematic reviews of the current state of published research in patient-reported outcomes in cancer RCTs indicated a lack of clear reporting of research hypothesis and analytic strategies, and inconsistency in definitions of terms, including “missing data,”“health-related quality of life,” and “patient-reported outcome.” Based on the meeting proceedings, the Consortium will focus on three key priorities in the coming year: developing a taxonomy of research objectives, identifying appropriate statistical methods to analyze patient-reported outcome data, and determining best practices to evaluate and deal with missing data. Conclusion The quality of the Consortium guidelines and recommendations are informed and enhanced by the broad Consortium membership which includes regulators, patients, clinicians, and academics.

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