The ISoP CommSIG for Improving Medicinal Product Risk Communication: A New Special Interest Group of the International Society of Pharmacovigilance

Bahri, Priya; Dodoo, Alexander; Edwards, Brian; Edwards, I. Ralph; Fermont, Irene; Hagemann, Ulrich; Hartigan-Go, Kenneth; Hugman, Bruce; Mol, Peter G. M.

doi:10.1007/s40264-015-0301-0

Cited by 17 publications

(7 citation statements)

References 30 publications

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“…[17][18][19][20] To address this methodological gap a number of studies and editorials have advocated a multidisciplinary approach to the assessment of DHPCs' effectiveness. 6,12,13,[20][21][22][23][24][25][26] Calls for multidisciplinarity are based on the notion that social scientific methods may complement understanding the clinical context and physicians' preferences and behavior in regards to DHPCs. The first step is to review the existing studies that provide knowledge on these aspects of communication.…”

Section: Introductionmentioning

confidence: 99%

The effectiveness of direct to healthcare professional communication – A systematic review of communication factor studies

Møllebæk

Kaae

Bruin

et al. 2019

Research in Social and Administrative Pharmacy

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Section: Introductionmentioning

confidence: 99%

The effectiveness of direct to healthcare professional communication – A systematic review of communication factor studies

Møllebæk

Kaae

Bruin

et al. 2019

Research in Social and Administrative Pharmacy

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“…Furthermore, evaluations should address process outcomes (reach, adoption, implementation), as well as examine the results in the short term (effectiveness) and the success of the message in the long term (maintenance and sustainability). Each of these concepts helped inform the contents of the draft RIMES checklist [ 9 , 11 , 14 , 16 , 25 – 34 , 37 ].…”

Section: Methodsmentioning

confidence: 99%

“…Improving the effectiveness of risk minimization programs is a priority within the pharmacovigilance community [ 7 – 9 ]. However, to date, the number of risk minimization evaluation studies reported in the peer-reviewed literature has lagged far behind the number that have been implemented thus far [ 10 ].…”

Section: Introductionmentioning

confidence: 99%

The RIMES Statement: A Checklist to Assess the Quality of Studies Evaluating Risk Minimization Programs for Medicinal Products

Smith

Russell

Bahri³

et al. 2017

Drug Saf

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IntroductionPharmaceutical risk minimization programs involve interventions designed to support safe and appropriate use of medicines. Currently, information regarding the evaluation of these programs is not publicly reported in a standardized and transparent manner. To address this gap, we developed and piloted a quality reporting checklist entitled the Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies (RIMES).MethodsChecklist development was guided by three sources: (1) a theoretical framework derived from program theory and process evaluation; (2) public health intervention design and evaluation principles; and (3) a review of existing quality reporting checklists. Two raters independently reviewed 10 recently published (2012–2016) risk minimization program evaluation studies using the proposed checklist. Inter-rater reliability of the checklist was assessed using Cohen’s Kappa and Gwet’s AC1.ResultsA 43-item checklist was generated. Results indicated substantial inter-rater reliability overall (κ = 0.65, AC1 = 0.65) and for three (key information, design and evaluation) of the four subscales (κ ≥ 0.64, AC1 ≥ 0.64). The fourth subscale (implementation) showed low reliability based on Cohen’s Kappa, but substantial reliability based on the AC1 (κ = 0.17, AC1 = 0.61).ConclusionsThe RIMES statement augments relevant elements from existing quality reporting guidelines with items that address aspects of intervention design, implementation and evaluation specific to pharmaceutical risk minimization programs. Our results show that the RIMES statement reliably measures key dimensions of reporting quality. This tailored checklist is an important first step in improving the reporting quality of risk minimization evaluation studies and may ultimately help to improve the quality of these interventions themselves.

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“…The CommSIG committed to build on this work and, as a starting point, consolidated previous ISoP discussions and proposals, further defining its main objectives and future paths in a publication in 2015. It has invited ISoP members to contribute and support the CommSIG in connecting with experts outside ISoP [4].…”

Section: Risk Communicationmentioning

confidence: 99%

An Update on ISoP Special Interest Groups (SIGs)

McCarthy

Bahri²,

Barnes

et al. 2017

Drug Saf

Self Cite

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The ISoP CommSIG for Improving Medicinal Product Risk Communication: A New Special Interest Group of the International Society of Pharmacovigilance

Cited by 17 publications

References 30 publications

The effectiveness of direct to healthcare professional communication – A systematic review of communication factor studies

The effectiveness of direct to healthcare professional communication – A systematic review of communication factor studies

The RIMES Statement: A Checklist to Assess the Quality of Studies Evaluating Risk Minimization Programs for Medicinal Products

An Update on ISoP Special Interest Groups (SIGs)

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