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Developing a Company-wide Process for Publication Plain Language Summaries

Angela Sykesa, Dheepa Charia, J.R. Meloroa

aPfizer Inc., New York, NY, USA

Abstract

Objective

Plain Language Summaries (PLSs), also known as lay summaries or patient lay summaries, communicate scientific content in everyday language so it is easily understood by a broader audience. Development of publication PLSs is relatively new to the scientific community. Here we describe the development of a company-wide process for publication PLSs.

Research design and methods

Pfizer's Oncology Organization partnered with the Enterprise Publication Team to implement a pilot for the development of congress abstract PLSs. The pilot ran for 1.5 years, throughout which feedback was gathered from patients, congress organizers, healthcare professionals (HCPs) and internal stakeholders (Medical, Legal, Corporate Affairs and Publications), in person and via telephone. This feedback was combined with input from Pfizer's Health Literacy and Medical Writing groups, based on their experience with developing PLSs for patient advocates and study participants, and incorporated into a company-wide guidance for abstract and manuscript PLSs.

Results

The oncology pilot involved 185 abstract PLSs across 11 congresses (7 United States [US], 4 ex-US), resulting in 6,936 views, downloads, prints and redirections to scientific abstracts. PLSs were available to congress attendees via poster QR codes for 60 days and, for four congresses, via Pfizer.com for two weeks. Stakeholder feedback was positive; however, patient advocates expressed the need for PLSs to be accessible and to endure beyond the congress. A company-wide guidance for abstract and manuscript PLS development was developed and training was provided to relevant stakeholders. A manuscript PLS was published using this guidance.

Conclusions

Having official guidance for the development of publication PLSs allows for a standard company-wide approach and promotes the idea of making information more accessible to patients and caregivers. Development of PLSs are being expanded to other therapeutic areas within Pfizer.

Background

  • Publications in scientific and medical journals are written for specialized audiences i.e. scientists and HCPs and, in general, are not easily understood by a general or lay audience. However, a recent study showed that nearly 50% of patients seek health information from journal articles, highlighting the need to provide this content in a way that can be easily understood by readers without scientific expertise.1
  • The increased focus on data transparency and patient centricity throughout the pharmaceutical industry has led many companies to recognize the importance of making information available to people who have an interest in learning about clinical study results but may have limited health literacy. Providing clinical data to patients and their caregivers in an easy-to-understand format is recognized as being an important unmet need by many in the industry.
  • In addition, research suggests that providing information to patients in plain language increases their understanding and engagement, while reducing anxiety and improving adherence.2
  • However, several barriers exist to the development of publication PLSs, including lack of available resources (e.g. experienced PLS writers and budget), capabilities, lack of ’best practice’, not knowing how and where to reach patients and the risk of appearing promotional.
  • Therefore, Pfizer decided to address this unmet need by initiating a congress abstract PLS pilot and using the learnings from this pilot to develop a company-wide publication PLS guidance.

Methods

  • The Pfizer Publications Management Team (PMT) partnered with Oncology Medical Affairs to implement a pilot for the development of congress abstract PLSs for key oncology congresses.
  • The pilot ran for 18 months, during which time the oncology team developed 185 abstract PLSs. PLSs were available to congress attendees via poster QR codes for 60 days and, for 4 congresses, via Pfizer.com for 2 weeks.
  • Throughout the pilot, feedback was gathered from patients, congress organizers, HCPs, authors and internal stakeholders and used to identify best practices for PLS development.
  • This feedback was combined with input from Pfizer's Health Literacy Group, Patient Advocacy Colleagues, Publications Attorney, Pfizer Worldwide Medical & Safety (WMS) leadership and was used by the PMT to develop company-wide guidance that governs the development of publication PLSs. This guidance also incorporated aspects of Pfizer's Medical Writing Group Standard Operating Procedure (SOP) requirements for development of Plain Language Study Results Summaries (PLSRS) to ensure that the company has a consistent enterprise-wide approach to the development of clinical study patient materials (Figure 1).
  • The PMT also established 7 standard levels of service (LoS) definitions for various kinds of PLSs (text only abstract PLSs, text with visuals abstract PLSs, infographic abstract PLSs, text only manuscript PLSs, text with visuals manuscript PLSs, infographic manuscript PLSs, and previously submitted or encore PLSs) and worked with Procurement to negotiate fixed rates for each LoS with each of our preferred vendors.
  • The PMT built abstract and manuscript PLS workflows in the publications management software system (Datavision).
  • Training on the guidance was provided by WebEx to all publication agency partners, publications specialists and oncology publication sub-committee (PSC) chairs. Publications specialists trained PSCs on the guidance.
  • A Publication PLS Guidance SharePoint page that includes the guidance, training slides and Datavision business rules was developed and made accessible to all Pfizer colleagues and publication agency partners.

Figure 1: Development of enterprise-wide publication PLS guidance

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*Feedback was gathered from external stakeholders (patients, congress organizers, HCPs and authors) and internal stakeholders (Medical, Legal, Corporate Affairs and PMT).
PLS, Plain Language Summary; PMT, Pfizer Publications Management Team; WMS, Pfizer Worldwide Medical and Safety.

Results

  • The oncology pilot included 185 abstract PLSs across 11 congresses, resulting in 6,936 actions (Figure 2).

Figure 2: Impact of oncology abstract PLS pilot

185 abstract PLSs
(ASCO 2018 + 2019; ESMO 2018 + 2019; ASCO-GU 2019; ASH 2018 + 2019;
SABCS 2018 + 2019; WCLC 2019; ESMO Asia 2019)
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ASCO, American Society of Clinical Oncology; ASH, American Society of Hematology; ESMO, European Society for Medical Oncology; GU, genitourinary; SABCS, San Antonio Breast Cancer Symposium; WCLC, World Conference on Lung Cancer.

  • The PMT began development of a publication PLS guidance document in October 2019 and completed development in February 2020 with an effective date of February 10, 2020. This was successfully implemented across Pfizer. As of April 2020, 5 of 6 Business Units (BUs) had either submitted an abstract or manuscript PLS, or had PLSs planned or in development.
  • The guidance includes standards for development of abstract and manuscript PLSs:
    • Appropriate language
    • Reading level (US 4th–6th grade level is recommended; should not exceed US-equivalent 8th grade level)3
    • Required elements
    • Development process
    • Approval process
  • The guidance also requires that a PLS based on a Pfizer-sponsored clinical study includes the key sections highlighted in Figure 3.
  • While the guidance was under development, a manuscript PLS was developed:
    • A link to the PLS appeared in PDF of manuscript immediately following the abstract
    • A link to the PLS was posted on Figshare with its own unique Digital Object Identifier (DOI)
  • The manuscript PLS had 368 views and 36 downloads, and an Altmetric score of 2 as of April 27, 2020.

Figure 3: Congress abstract PLS example*

*Abstract PLS presented at ESMO congress, September 27–October 1, 2019, Barcelona, Spain.
ESMO, European Society for Medical Oncology.

Recommendations

  • Before introducing enterprise-wide publication PLS guidance, conduct a pilot to ensure any potential issues are identified, assessed and adequately addressed before wider execution.
  • Convene a cross-functional team to provide input into the development of the PLS guidance and ensure alignment across the company.
  • Follow best practices for introduction of PLS guidance (Figure 4):
    • Standard process
    • Structured workflows
    • Training of colleagues and agencies
    • Approved lexicon
    • Defined LoS with fixed fees

Figure 4: Best practices for PLS implementation

Standard process

Regardless of therapy area or asset, ensure a consistent process is adhered to for author involvement, content development, and review/approval process.

Structured workflow

Utilize fixed PLS Datavision document templates to support adherence with the development process.

Training of colleagues & agencies

PLS development is an emerging area of expertise; therefore, to ensure optimal quality, it is important that colleagues and agency partners are trained in the processes and content development best practices.

Approved lexicon

Align with health literacy best practices by consistently using language that is easily understood by a lay audience. This means avoiding jargon and translating technical terminology into language that is understandable to patients.

Fixed definitions & fees

Partner with procurement to clearly define PLS LoS and fixed fees, and evaluate vendor capabilities.

Next steps

  • Publication PLS guidance will be incorporated into the Enterprise-Wide Publication SOP.
  • Compliance with PLS guidance will be monitored.
  • Publication PLS activities will be measured.
    • Number of abstract and manuscript PLSs by BUs
    • Number of abstract and manuscript PLSs by product
    • Development costs of abstract and manuscript PLSs
    • Impact (e.g. downloads, views, Altmetric scores)

Polling questions and conclusions

Conclusions

  • PLSs allow for equity of information access as they make clinical publications understandable to patients, caregivers, non-specialist HCPs and the general public. When developing PLSs, companies must ensure that appropriate controls are established such that they will be developed in accordance with health literacy principles and best practices.
Author affiliations: Pfizer Inc., New York, NY, USA
Poster presented at the 16th Annual Meeting of ISMPP, 16–18 June, 2020
(virtual meeting)
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References: 1. Pushparajah DS, et al. Therapeutic Innovation & Regulatory Science. 2018;52:474–481; 2. Prediger B, et al. Trials. 2019;20:458; 3. Stossel LM, et al. J Gen Intern Med. 2012;27:1165–1170.
Acknowledgements: Poster layout and formatting assistance provided by Jilly Hope of Bioscript Medical, Macclesfield, UK, and funded by Pfizer.
Disclosures: All authors participated in the project, were actively involved in preparing the abstract and poster and provided approval for submission.
All authors are full-time employees of Pfizer Inc. and hold stock and/or stock options with Pfizer Inc.
Key sections