Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium Guidance

Banerjee, Anjan K.; Okun, Sally; Edwards, I. Ralph; Wicks, Paul; Smith, Meredith Y.; Mayall, Stephen J.; Flamion, Bruno; Cleeland, Charles S.; Basch, Ethan

doi:10.1007/s40264-013-0113-z

Cited by 84 publications

(75 citation statements)

References 43 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…As the experience in using these measures increased it became obvious that there is a clinical value in using individual patient PROs profiles in daily practice to give clinicians standardized information on patient problems to identify/monitor symptoms, evaluate treatment outcomes and support shared decisionmaking. [2][3][4][5][6][7][8] Recently, PROs became widely accessible to clinicians via electronic/online reporting with new developments towards integration with Electronic Health Records (EHRs) via patient portals. 2 The integration of PROs with clinical data in EHRs offers innovative opportunities of including patient perspective in Big Dataset for analysis and rapid learning from combined biological, clinical and treatment information.…”

Section: Introductionmentioning

confidence: 99%

“…The importance of PROs is increasingly recognized as an essential part of drug safety reporting, Comparative Effectiveness Research and patient-centred outcomes approaches. [3][4][5][6] However, these innovative opportunities can only be realized if practicing clinicians understand the values of PROs in patient care and start collecting and utilizing the information in their daily work. The barriers to implementing the use of PROs in routine clinical care 7 included scepticism about the validity of patient self-report, unfamiliarity with PROs, preference for physiologic measures, and uncertainty how to interpret the information and make it actionable in clinical care.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Training clinicians in how to use patient-reported outcome measures in routine clinical practice

et al. 2015

View full text Add to dashboard Cite

Patient-reported outcome measures (PROs) were originally developed for comparing groups of people in clinical trials and population studies, and the results were used to support treatment recommendations or inform health policy, but there was not direct benefit for the participants providing PROs data. However, as the experience in using those measures increased, it became obvious the clinical value in using individual patient PROs profiles in daily practice to identify/monitor symptoms, evaluate treatment outcomes and support shared decision-making. A effectively utilize PROs data in their clinical encounters.The implementation of PROs in patient care represents a significant change to clinical practice of individual clinicians and health organisations. Using a change-management theoretical framework, this paper describes the development and implementation of three programs for training clinicians to effectively use PRO data in routine practice. The training programs are in three diverse clinical areas (adult oncology, lung transplant and paediatrics), in three countries with different health care systems, thus providing a rare opportunity to pull out common approaches whilst recognizing specific settings. For each program we describe the clinical and organisational setting, the program planning and development, the content of the training session with supporting material, subsequent monitoring of PROs use and evidence of adoption. The common successful components and practical steps are identified, leading to discussion and future recommendations. The common successful components are identified, leading to discussion and future recommendations.

show abstract

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Training clinicians in how to use patient-reported outcome measures in routine clinical practice

et al. 2015

View full text Add to dashboard Cite

show abstract

“…The fragmented nature of PV in the global context presents the UMC with a multitude of challenges. Currently, problems such as under-reporting and the communication of incomplete, unrepresentative, and uncontrolled data prove to be significant barriers to detecting and characterising new adverse drug interactions and ADRs [7]. A 2016 study by Bailey et al [8] identified 108 ADR reporting systems and highlighted a number of challenges associated with the lack of a standardised ADR reporting form.…”

Section: Contextmentioning

confidence: 99%

An Investigation Into the Value of a Standardised Global Pharmacovigilance Reporting System

Schurer

Bam

Kock

2017

SAJIE

View full text Add to dashboard Cite

Pharmacovigilance (PV) is based on the medical assessment of adverse medical events or drug-related problems, collected within organised health programmes. The large number of different PV systems, the equally large number of stakeholders within such systems (pharmaceutical companies, government regulatory bodies, national and international clinical regulatory bodies, healthcare workers, etc.), and the significant number of dimensions along which the effectiveness and efficiency could be measured, adds to this complexity. Furthermore, the lack of a standardised reporting protocol across the various PV systems hinders efforts to manage PV coherently on a global scale. This paper proposes the value of a standardised global PV reporting system by evaluating the systemic effects of the lack of such a standardised system. OPSOMMINGFarmakologiese waaksaamheid (PV) is gebaseer op die mediese assessering van nadelige mediese gebeure of dwelmverwante probleme wat deur georganiseerde gesondheidsprogramme versamel word. Die groot aantal verskillende PV-sisteme, die ewe groot aantal belanghebbendes in sulke stelsels (farmaseutiese maatskappye, regerings, nasionale en internasionale kliniese reguleringsliggame, gesondheidswerkers, ens.), en die aansienlike aantal dimensies waarvolgens die effektiwiteit en doeltreffendheid gemeet kan word, dra by tot hierdie kompleksiteit. Verder belemmer die gebrek aan 'n gestandaardiseerde rapporteringsprotokol wat oor die verskillende PV-sisteme strek die pogings om PV op 'n wêreldwye skaal konsekwent te bestuur. Hierdie artikel stel die waarde van 'n gestandaardiseerde globale PV rapporteringsprotokol voor deur die sistematiese gevolge van die gebrek aan so 'n gestandaardiseerde stelsel te evalueer

show abstract

“…The important role of patients in identifying, describing, and ultimately avoiding, harm from medicines is increasingly recognized [1,2], and modern technologies are being explored to facilitate patient engagement [3]. Information on direct patient reports in pharmacovigilance differs in certain respects from information provided by health professionals, but has been found to be of complementary value [4].…”

mentioning

confidence: 99%

“…The former resemble the free-text narratives of individual case reports, should be encoded in standard E2B format 2 , and captured by the regular pharmacovigilance system, presuming that they fulfil reporting requirements. This will enable their inclusion in regular pharmacovigilance signal detection and analysis.…”

mentioning

confidence: 99%

Pharmacovigilance for a Revolving World: Prospects of Patient-Generated Data on the Internet

Norén

2014

Drug Saf

View full text Add to dashboard Cite

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium Guidance

Abstract: The Patient-Reported Outcomes

Cited by 84 publications

References 43 publications

Training clinicians in how to use patient-reported outcome measures in routine clinical practice

Training clinicians in how to use patient-reported outcome measures in routine clinical practice

An Investigation Into the Value of a Standardised Global Pharmacovigilance Reporting System

Pharmacovigilance for a Revolving World: Prospects of Patient-Generated Data on the Internet

Contact Info

Product

Resources

About