• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

医学事务制药医师价值(MAPPval)工具的开发和验证。

Development and Validation of the Medical Affairs Pharmaceutical Physician Value (MAPPval) Instrument.

机构信息

Medialis Ltd, 13 Horse Fair, Banbury, Oxford, OX16 0AH, UK.

Faculty of Life Science and Medicine, Centre for Pharmaceutical Medicine Research, Institute of Pharmaceutical Science, King's College University, Franklin Wilkins Building, 150 Stamford Street, London, SE1 9NH, UK.

出版信息

Pharmaceut Med. 2022 Feb;36(1):47-57. doi: 10.1007/s40290-021-00413-9. Epub 2022 Jan 7.

DOI:10.1007/s40290-021-00413-9
PMID:34994965
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8818008/
Abstract

BACKGROUND

A pilot study conducted in 2020 suggested that Medical Affairs Pharmaceutical Physicians (MAPPs) may be inherently undervalued within the pharmaceutical industry and vulnerable to replacement by less qualified roles. There are currently no standardized metrics to measure MAPP performance, thus it is necessary to measure the value of MAPPs to employers and clarify the need for their specific skills.

OBJECTIVES

The first aim of this study was to identify a list of indicators to produce an MAPP value measurement tool, and the second aim was to determine its discriminant validity by showing that the 'MAPPval instrument' differentiated the MAPP role from other internal stakeholders (regulatory affairs, market access, commercial, and patient advocacy) in terms of accountability for pharmaceutical company activities and level of engagement with external stakeholders.

METHODS

MAPPs were recruited using convenience sampling via professional networks and completed a qualitative online survey to identify a list of key role indicators using a consensus method known as the Jandhyala method. Responses were coded and scored, and aggregated responses were presented to participants in a Consensus Round. Participants rated their agreement with each item on a 5-point Likert scale, from strongly agree to strongly disagree. Indicators that reached a consensus index of > 50% (CI ≥ 0.51) were retained in the final MAPP performance instrument. Participants' retrospectively self-reported professional activities over a period of 12 months were used to validate the measure. A two-proportion z-test and Mann-Whitney tests were used to determine discriminant validity by showing whether the value of the MAPP role as defined by the instrument was significantly different from that of other internal stakeholders in terms of their accountability for and external stakeholder benefit from each MAPP activity.

RESULTS

In total, 11 MAPPs participated in the Jandhyala method, which generated 22 unique MAPP value indicators. Payor-targeted activities and journal publications had the two highest awareness indexes (1.00 and 0.98, respectively). The retrospective study confirmed the MAPPval instrument's validity. MAPPs were the only internal stakeholder classified as accountable for at least one activity that benefited all four stakeholders. They were classified as accountable for activities that influenced significantly more external stakeholders than other internal stakeholders, even when activities influenced fewer than four external stakeholders. MAPPs were also accountable for significantly more activities recorded over the 12-month period than regulatory affairs, market access, commercial, and patient advocacy.

CONCLUSIONS

This study generated and validated the first measure of MAPP value to pharmaceutical companies. MAPPs have unique value to pharmaceutical companies compared with other roles in terms of their accountability for activities that influence regulators, payors, prescribers, and patients. Through their accountability for pharmaceutical company activities and influence of external stakeholders, MAPPs play a key role in medicine adoption.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4c9/8818008/f21cd0dd2d0f/40290_2021_413_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4c9/8818008/6e7fdd12f7f9/40290_2021_413_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4c9/8818008/f21cd0dd2d0f/40290_2021_413_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4c9/8818008/6e7fdd12f7f9/40290_2021_413_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4c9/8818008/f21cd0dd2d0f/40290_2021_413_Fig2_HTML.jpg
摘要

背景

2020 年进行的一项试点研究表明,医学事务制药医师(MAPP)在制药行业内可能被低估,并且容易被资格较低的角色所取代。目前没有衡量 MAPP 绩效的标准化指标,因此有必要衡量 MAPP 对雇主的价值,并明确他们特定技能的需求。

目的

本研究的首要目标是确定一系列指标,以制定 MAPP 价值衡量工具,其次是通过表明“MAPPval 工具”在对制药公司活动的问责制和与外部利益相关者的互动程度方面,能够将 MAPP 角色与其他内部利益相关者(监管事务、市场准入、商业和患者宣传)区分开来,从而确定其判别有效性。

方法

通过专业网络,采用便利抽样法招募 MAPP,并通过共识方法(即 Jandhyala 方法)完成在线定性调查,以确定一系列关键角色指标。使用共识方法对回复进行编码和评分,并在共识轮中向参与者展示聚合回复。参与者使用 5 分李克特量表对每个项目的同意程度进行评分,从非常同意到非常不同意。达到共识指数>50%(CI≥0.51)的指标被保留在最终的 MAPP 绩效工具中。参与者在过去 12 个月内回顾性地报告专业活动,以验证该衡量标准。使用两比例 z 检验和曼-惠特尼检验来确定判别有效性,通过表明仪器定义的 MAPP 角色的价值与其他内部利益相关者在对每项 MAPP 活动的问责制和外部利益相关者的受益方面是否存在显著差异来证明这一点。

结果

共有 11 名 MAPP 参与了 Jandhyala 方法,生成了 22 个独特的 MAPP 价值指标。针对支付方的目标活动和期刊出版物的意识指数最高(分别为 1.00 和 0.98)。回顾性研究证实了 MAPPval 工具的有效性。MAPP 是唯一被归类为对至少一项对所有四个利益相关者都有益的活动负责的内部利益相关者。他们被归类为对影响监管机构、支付方、处方医生和患者的活动负责,比其他内部利益相关者负责的活动影响更多的外部利益相关者,即使这些活动影响的外部利益相关者少于四个。MAPP 还负责记录的活动明显多于监管事务、市场准入、商业和患者宣传在过去 12 个月内记录的活动。

结论

本研究生成并验证了第一个衡量制药公司 MAPP 价值的工具。与其他角色相比,MAPP 对制药公司具有独特的价值,因为他们对影响监管机构、支付方、处方医生和患者的活动负责。通过对制药公司活动的问责制和对外部利益相关者的影响,MAPP 在药物采用中发挥着关键作用。

相似文献

1
Development and Validation of the Medical Affairs Pharmaceutical Physician Value (MAPPval) Instrument.医学事务制药医师价值(MAPPval)工具的开发和验证。
Pharmaceut Med. 2022 Feb;36(1):47-57. doi: 10.1007/s40290-021-00413-9. Epub 2022 Jan 7.
2
Observing expert opinion of medical affairs pharmaceutical physicians on the value of their clinical experience to the pharmaceutical industry using the Jandhyala method.运用詹迪亚拉方法观察医学事务制药医师对其临床经验对制药行业价值的专家意见。
Curr Med Res Opin. 2023 Dec;39(12):1541-1550. doi: 10.1080/03007995.2023.2165814. Epub 2023 Jan 16.
3
Professional qualifications of medical affairs pharmaceutical physicians and other internal stakeholders in the pharmaceutical industry.医药事务医学事务代表及医药行业其他内部利益相关者的专业资质。
F1000Res. 2022 Jul 22;11:813. doi: 10.12688/f1000research.123182.2. eCollection 2022.
4
Development of a Definition for Medical Affairs Using the Jandhyala Method for Observing Consensus Opinion Among Medical Affairs Pharmaceutical Physicians.运用詹迪亚拉方法观察医药事务制药医师的共识意见来制定医药事务的定义
Front Pharmacol. 2022 Feb 22;13:842431. doi: 10.3389/fphar.2022.842431. eCollection 2022.
5
Development, validation and implementation of the medical affairs pharmaceutical physician work-related quality of life instrument.医学事务制药医师工作相关生活质量工具的开发、验证与实施
Curr Med Res Opin. 2023 Dec;39(12):1567-1574. doi: 10.1080/03007995.2023.2174747. Epub 2023 Feb 8.
6
The multiple stakeholder approach to real-world evidence (RWE) generation: observing multidisciplinary expert consensus on quality indicators of rare disease patient registries (RDRs).多利益相关者方法在真实世界证据(RWE)生成中的应用:观察罕见病患者登记处(RDR)质量指标的多学科专家共识。
Curr Med Res Opin. 2021 Jul;37(7):1249-1257. doi: 10.1080/03007995.2021.1927689. Epub 2021 May 21.
7
Development of a definition for real-world evidence using the Jandhyala method for observing consensus opinion among medical affairs pharmaceutical physicians.使用詹迪亚拉方法观察医学事务制药医师之间的共识意见,制定真实世界证据的定义。
Curr Med Res Opin. 2023 Dec;39(12):1551-1558. doi: 10.1080/03007995.2023.2172261. Epub 2023 Feb 10.
8
A medicine adoption model for assessing the expected effects of additional real-world evidence (RWE) at product launch.一种用于评估产品上市时额外真实世界证据(RWE)预期效果的药物采用模型。
Curr Med Res Opin. 2021 Sep;37(9):1645-1655. doi: 10.1080/03007995.2021.1947218. Epub 2021 Jul 8.
9
Pedi-R-MAPP: The development of a nutritional awareness tool for use in remote paediatric consultations using a modified Delphi consensus.儿童远程医疗营养评估工具(Pedi-R-MAPP):使用改良 Delphi 共识开发的用于远程儿科咨询的营养意识工具。
Clin Nutr. 2022 Mar;41(3):661-672. doi: 10.1016/j.clnu.2022.01.009. Epub 2022 Jan 13.
10
Identifying Outcome Measures for Migraine Value-Based Contracting Using the Delphi Method.采用德尔菲法确定偏头痛基于价值的合同的结果衡量指标。
Headache. 2020 Nov;60(10):2139-2151. doi: 10.1111/head.13978. Epub 2020 Sep 30.

引用本文的文献

1
Artificial Intelligence in Medical Affairs: A New Paradigm with Novel Opportunities.人工智能在医疗事务中的应用:一种具有新机遇的新模式。
Pharmaceut Med. 2024 Sep;38(5):331-342. doi: 10.1007/s40290-024-00536-9. Epub 2024 Sep 11.
2
Development of a Definition for Medical Affairs Using the Jandhyala Method for Observing Consensus Opinion Among Medical Affairs Pharmaceutical Physicians.运用詹迪亚拉方法观察医药事务制药医师的共识意见来制定医药事务的定义
Front Pharmacol. 2022 Feb 22;13:842431. doi: 10.3389/fphar.2022.842431. eCollection 2022.

本文引用的文献

1
Design, validation and implementation of the post-acute (long) COVID-19 quality of life (PAC-19QoL) instrument.设计、验证和实施急性后期(长) COVID-19 生活质量(PAC-19QoL)工具。
Health Qual Life Outcomes. 2021 Sep 28;19(1):229. doi: 10.1186/s12955-021-01862-1.
2
A medicine adoption model for assessing the expected effects of additional real-world evidence (RWE) at product launch.一种用于评估产品上市时额外真实世界证据(RWE)预期效果的药物采用模型。
Curr Med Res Opin. 2021 Sep;37(9):1645-1655. doi: 10.1080/03007995.2021.1947218. Epub 2021 Jul 8.
3
A simple core dataset and disease severity score for hereditary transthyretin (ATTRv) amyloidosis.
遗传性转甲状腺素蛋白(ATTRv)淀粉样变的一个简单核心数据集和疾病严重程度评分。
Amyloid. 2021 Sep;28(3):189-198. doi: 10.1080/13506129.2021.1931099. Epub 2021 May 27.
4
The multiple stakeholder approach to real-world evidence (RWE) generation: observing multidisciplinary expert consensus on quality indicators of rare disease patient registries (RDRs).多利益相关者方法在真实世界证据(RWE)生成中的应用:观察罕见病患者登记处(RDR)质量指标的多学科专家共识。
Curr Med Res Opin. 2021 Jul;37(7):1249-1257. doi: 10.1080/03007995.2021.1927689. Epub 2021 May 21.
5
Neutral theory: applicability and neutrality of using generic health-related quality of life tools in diseases or conditions where specific tools are available.中性理论:在有特定工具可用的疾病或情况下使用通用健康相关生活质量工具的适用性和中性。
BMC Med Res Methodol. 2021 Apr 26;21(1):86. doi: 10.1186/s12874-021-01279-w.
6
Delphi, non-RAND modified Delphi, RAND/UCLA appropriateness method and a novel group awareness and consensus methodology for consensus measurement: a systematic literature review.德尔菲法、非随机化德尔菲法、RAND/UCLA 适宜性方法和一种新的共识测量群体意识和共识方法:系统文献回顾。
Curr Med Res Opin. 2020 Nov;36(11):1873-1887. doi: 10.1080/03007995.2020.1816946. Epub 2020 Sep 15.
7
A novel method for observing proportional group awareness and consensus of items arising from list-generating questioning.一种用于观察源于列表生成问题的项目的比例分组意识和共识的新方法。
Curr Med Res Opin. 2020 May;36(5):883-893. doi: 10.1080/03007995.2020.1734920. Epub 2020 Mar 11.
8
On-Label or Off-Label? Overcoming Regulatory and Financial Barriers to Bring Repurposed Medicines to Cancer Patients.标签内用药还是标签外用药?克服监管和财务障碍,将重新利用的药物带给癌症患者。
Front Pharmacol. 2020 Jan 31;10:1664. doi: 10.3389/fphar.2019.01664. eCollection 2019.
9
Influence of Pharmaceutical Company Engagement Activities on the Decision to Prescribe: A Pilot Survey of UK Rare Disease Medicine Prescribers.制药公司参与活动对处方决策的影响:对英国罕见病药物开方者的试点调查。
Pharmaceut Med. 2020 Apr;34(2):127-134. doi: 10.1007/s40290-019-00323-x.
10
What matters most? Different stakeholder perspectives on estimands for an invented case study in COPD.最重要的是什么?COPD 虚构病例研究中评价指标的不同利益相关者观点。
Pharm Stat. 2020 Jul;19(4):370-387. doi: 10.1002/pst.1986. Epub 2020 Jan 9.