Original Abstracts from the 15th Annual Meeting of ISMPP

Figures & data

Table 1. Online survey results.

Please answer (Yes/No) to _____________ of the role of PMWs as described in the JPS to help authors and sponsors disclose their research in peer-reviewed journals/scientific congresses in an ethical, accurate, and timeline manner
Your Confidence			22/22 (100%)
The Evaluability			19/22 (86%)
The Perceived Evidence in the Literature			18/22 (82%)
How often do you think PMWs should qualify for authorship (% of time)?
>90		50–89		1–49		0		Don’t know
2018	2013	2018	2013	2018	2013	2018	2013	2018	2013
Systematic reviews
9	34	50	31	27	22	9	6	5	8
Narrative reviews
9	22	18	28	41	26	18	14	14	10
Primary research articles
5	18	5	14	41	36	45	25	5	7

*2013 polling data = responses of “always”, “frequently”, “occasionally”, “never”, and “don’t know” in survey circulated to clinicians, researchers, and medical publication professionals (n = 155).

† Data = sum of “>90” or “always” and “50–89” or “frequently” groups

Figure 1. Flow chart of journal responses analyzed and comment categories.

Table 1. Comparison of student rotation programs.

	Student 1	Student 2	Student 3
Student educational background	PhD candidate from a US-based university	Undergraduate student from a US-based university	PhD candidate from a UK-based university
Approximate length of rotation period	72 hours	144 hours	487 hours
Student received same mentor and based in same office?	Yes	Yes	Yes
Student received company induction sessions required of new hires?	Yes	Yes	Yes
Student received an exit interview, conducted by the same HR staff member?	Yes	Yes	Yes
Student interacted with people from different roles within the company?	Yes	Yes	Yes
Work/projects	No billable work due to nature of rotation Completed a writing exercise Reviewed training decks and attended training sessions	Two billable projects with a single account/therapeutic area Completed a writing exercise Reviewed training decks and attended training sessions	Several billable projects with multiple accounts/therapeutic areas Completed editorial assessment tests Reviewed training decks and attended training sessions
Productivity (% billable hours)	Not applicable; did not do billable work and did not complete timesheets	2.9%	46.5%
Cost (hourly wage multiplied by total hours worked)	None; partnership with a program in the student’s university	$2,160.00 (hourly wage of $15)	None; received course credits towards student’s PhD program

Figure 1. Rate of results disclosure and publication for industry-sponsored early-phase I and phase I clinical trials conducted in the USA vs EU. (A) Trial disclosure and publication overall and by geographic region. (B) Disclosure and publication in USA trials vs EU trials by disease area.

short-legendFigure 1.

Table 1. Spearman’s rank correlation coefficient between STJA per million population and social well-being indicators

Indicator	Data source	URL	Completepairs, n	Spearman’s rankcorrelationcoefficient	p-value
Scientific and technical journal articles (STJA)	National Science Foundation	https://data.worldbank.org/indicator/IP.JRN.ARTC.SC		—	—
Happy Planet Index (HPI)	New Economics Foundation	http://happyplanetindex.org/	137	0.247	.004
Human Development Index (HDI)	United Nations Development Programme	http://hdr.undp.org/en/data#	186	0.897	<.001
Gini index^Table Footnotea	Central Intelligence Agency	https://www.cia.gov/library/publications/the-world-factbook/rankorder/2172rank.html	147	0.447	<.001
Sustainable Economic Development Assessment (SEDA)	Boston Consulting Group	https://www.bcg.com/en-gb/publications/interactives/seda-2018-guide.aspx	150	0.905	<.001
World Happiness Report (WHR) score	World Happiness Report	http://worldhappiness.report/ed/2018/	137	0.674	<.001

^aThe Gini index ranks inequality in the distribution of family income, where a lower score represents lower inequality; this was ranked with the lowest score equaling 1. All other variables were ranked with the highest score equaling 1.

Table 1. Timing and duration of views for videos A, B1, and B2^a

		Views, n
Day		A	B1	B2
1 (presentation day)		52	158	10
2		34	137	1
3		11	87	6
4		8	49	8
5		1	45	14
6		5	21	0
7		4	2	0
1–7		115	499	39
8–14		28	49	6
15–21		10	47	4
22–30		10	37	0

	Content
Timepoint, %	A (Phase II data)	B1/B2 (Phase III data)	Views that reached each timepoint, %
10	Background	Background	92	97	98
20	Background	Trial design	78	79	76
30	Background	Trial design	71	69	63
40	Background	Efficacy	68	65	55
50	Trial design	Efficacy	66	61	51
60	Efficacy	Efficacy	63	59	43
70	Efficacy	Efficacy	58	56	43
80	Efficacy	Efficacy	56	54	39
90	Safety	Safety	55	51	35
100	Conclusions	Conclusions	53	49	33

^a One person could have multiple views; viewers were anonymous.

Table 1. Summary of online survey responses from patients, pharma, publishers, and publication professionals.

#	Question	% of respondents
		Strongly disagree	Disagree	Neutral	Agree	Strongly agree
1	There is a growing interest among patients and the public in the latest scientific research published in medical journals	4	1	10	38	47
2	Published plain language summaries of publications should be easy to find and free (open-access) for patients and the public	2	0	2	18	78
3	Plain language summaries of publications should be co-created with patients (e.g. patient input, patient review before submission)	1	6	13	29.	51
		Overall score^a (1 = highest priority; 6 = lowest priority)
4	To increase the availability of plain language summaries of publications, particularly for research funded by the pharmaceutical industry, there needs to be:
	Patient and public demand for plain language summaries of publications					4.47
	Encouragement of plain language summaries of publications by journal editors and publishers					4.29
	Funding for development of plain language summaries of publications					3.49
	A free to access repository to find and store PLS of publications					3.15
	Practical tools for plain language summaries of publications					2.90
	Pharmaceutical industry guidance on PLS of publications					2.71
^aAll options received a highest priority ranking.  The higher the average weighted score, the higher the preference
	Example feedback from free-text responses received (n = 30)
5	“Publication of research accessible to everyone must become a standard way of thinking and working moving forward. Findings should be accessibleto all audiences, free at the point of access, and delivered into communities. For research to move forward, communities need to feel engagedand involved ... and this can only happen if we evolve our current ways of working”. “Quality frameworks and governance are important to ensure transparency, consistency, and accuracy of patient summaries across journals, disease areas, and geographic territories”.

Table 1. Summary of open-access vs data-sharing (ICMJE journal members)²

Journal name	IF	AI	Frequency	Open-access	Data-sharing policy
Bulletin of the World Health Organization^1	6.361	2.889	Monthly	Full open access	Yes
Journal of Korean Medical Science	1.588	0.421	Weekly	Full open access	Yes
PLOS Medicine	11.675	6.584	Weekly	Full open access	Yes
Ugeskrift for Laeger (Danish Medical Journal)	1.137	0.439	Monthly	Full open access	Yes
New England Journal of Medicine	79.258	29.423	Continuous (52 per year)	Delayed 6 months; free access in >90 low-income countries	Yes
JAMA (Journal of the American Medical Association)	47.7	19.947	Continuous (48 per year)	Delayed 6 months; free access via WHO HINARI	Yes
Annals of Internal Medicine	19.384	9.222	Weekly online, bi-weekly print	Hybrid open access	Yes
British Medical Journal	23.259	8.422	Weekly (online)	Hybrid open access	Yes
The Lancet	53.254	21.006	Continuous (52 per year)	Hybrid open access	Yes
Deutsches Ärzteblatt (German Medical Journal)	4.51	n/a	Weekly (online)	Full open access	N/A
Ethiopian Journal of Health Sciences	n/a	n/a	Bi-monthly	Full open access	N/A
Iranian Journal of Medical Sciences	n/a	n/a	Bi-monthly	Full open access	N/A
New Zealand Medical Journal	n/a	n/a	22 issues/year	Hybrid open access	N/A
Revista Médica de Chile (Medical Journal of Chile)	0.456	0.104	Monthly	Available online	N/A

Table 1 Evidence-based recommendations for patient involvement, customized to publications

#	Recommendation	Supporting references
Before manuscript preparation begins
1	Ideally, involve patients in the question formulation stage (e.g. involve patients in publication planning to ensure publications address unmet needs that are relevant and important to patients)	^Citation1^,^Citation3^,^Citation4^,^Citation6–9
2	Identify patient author candidates who are interested in contributing, have relevant expertise (e.g. lived experience), and can meet authorship criteria (i.e. no guest authorship); document permitted contact details for patient authors in publication management software	^Citation1^,^Citation5–7^,^Citation9
3	Clarify and document author and contributor roles and responsibilities (e.g. signed Authorship Agreements should help ensure expectations are clear and understood; patient involvement should not be tokenistic; archive signed Agreements)	^Citation1^,^Citation3^,^Citation5–7^,^Citation9
4	Ensure support for patient authors from non-patient authors, especially the primary author and publication guarantor	^Citation5^,^Citation7^,^Citation9
5	Appoint a designated contact person for patient authors to reach out to with queries (e.g. a Certified Medical Publication Professional who has publication expertise, project knowledge, and time to support patient authors)	^Citation5^,^Citation7^,^Citation9
6	Identify relevant publication and patient involvement guidelines that will be followed (e.g. CONSORT, GRIPP2, GPP3)	^Citation6^,^Citation7
7	Check that funding facilitates patient author involvement (e.g. upfront payment of travel expenses for author meetings and conference presentations, translator fees if necessary)	^Citation1^,^Citation3^,^Citation5–9
8	Prepare a publication timeline that facilitates patient author involvement (e.g. early delivery of materials to review; contingency time for unexpected unavailability—illness, employment, other commitments)	^Citation3^,^Citation5–7^,^Citation9
9	Consider providing a publication induction guide and training for patient authors (e.g. plain language summary of GPP3, glossary of publication terms, overview of publication process)	^Citation1–3^,^Citation5–7^,^Citation9
10	Consider how to proactively and systematically evaluate the effect of patient involvement (e.g. document feedback via publication management software; administer patient authorship experience tools)	^Citation1^,^Citation3^,^Citation5^,^Citation7–9
During manuscript preparation
11	Recognize and respect diversity in the authorship team—everyone should contribute and be listened to. Patient authors can provide unique and useful input from their lived experience (they are not expected to be statisticians, clinicians, medical writers, etc.)	^Citation1^,^Citation5^,^Citation7
12	Be flexible in how patient authors can provide input (e.g. telephone, email, in person)	^Citation1^,^Citation4–9
13	Allow time before, during, and after authorship meetings to address concerns and questions about patient authorship—from patient and non-patient authors	^Citation6^,^Citation7^,^Citation9
14	Provide timely and regular feedback to patient authors on their contributions and group dynamics	^Citation1^,^Citation3–5^,^Citation7–9
15	Consider presenting key results at authorship meetings and in publications that could make it quicker and easier for non-specialists to understand and interpret findings (e.g. use data visualization, flowcharts, etc. …)	^Citation2^,^Citation3^,^Citation8^,^Citation9
16	Recognize that patient authors may provide stronger contributions if able to provide input in their local language	^Citation8
17	Document, in the manuscript, the involvement and role of patient authors (i.e. identify which authors are patients [e.g. Author Affiliation section] and describe their authorship contributions [e.g. Contributorship section])	^Citation3^,^Citation9
After manuscript preparation is completed
18	Provide updates on progress with the publication	^Citation6^,^Citation9
19	Involve patients in the publication dissemination plan (e.g. raising awareness of the publication via patient advocacy groups, community and personal networks, social media platforms; contributing to and testing plain language summaries—ensuring cultural and linguistic appropriateness)	^Citation1–5^,^Citation7–9
20	Encourage continued participation (e.g. patient authors presenting results—target geographically close conferences, leverage remote presentation tools; involvement in follow-up publication projects and publication steering committees)	^Citation1^,^Citation4–6^,^Citation8
21	Consider preparing a companion publication on the effect of patient involvement	^Citation1^,^Citation7

Table 1. Characteristics of identified publications reporting data from US and EU patient registries.

	% of publications reporting US patient registry data^a(n = 81)	% of publications reporting EU patient registry data^b(n = 53)
Year of publication
2001–2006^c	2.5	9.4
2007–2012	21.0	35.8
2013–2018	76.5	56.6
Authorship
≥1 US author	98.7	3.8
All US authors	80.2	0.0
≥1 EU author	8.6	96.2
All EU authors	0.0	86.8
Main research objectives and data reported
Patient/disease characteristics	54.3	41.5
Safety	22.2	49.1
Treatment patterns	28.4	17.0
Efficacy	22.2	17.0
Patient-reported outcomes	16.0	18.9
Health economic outcomes	2.5	7.5

a US patient registry: Corrona.

b EU patient registries: BSRBR, RABBIT.

c All three registries were established in 2001; the earliest year of publication was 2003. Duplicates and articles not relating to one of the three patient registries were excluded.

BSRBR, British Society of Rheumatology Biologics Register; EU, European Union; RABBIT, Rheumatoide Arthritis: Beobachtung der Biologika-Therapie (German Biologics Register); US, United States.

Table 1 Results: value framework and health technology assessment methods documentation requirements on data sources.

Organization	Country/organizationtype	Specifiesliteraturesearch strategy	Specifiesdata sources*	Providesguidanceon dataextraction	Explicitlyreferencespeer-reviewedliterature	Acceptsgrey literature	Acceptsconfidentialproprietary data
Value framework organizations
American College of Cardiology/American Heart Association (ACC)	US CL	No	No	No	No	No	No
American Society of Clinical Oncology (ASCO)	US CL	No	No	No	Yes	No	No
Avalere/FasterCures (A/FC)	US NP	No	No	No	Yes	No	No
Innovation and Value Initiative (IVI)	US NP	Yes	Yes	No	No	No	No
Institute for Clinical Economic Review (ICER)	US NP	No	Yes	Yes	Yes	Yes	Yes
Memorial Sloan Kettering Cancer Center (MSK)	US CL	No	No	No	No	UA	No
National Comprehensive Cancer Network (NCCN)	US CL	UA	No	No	No	No	No
Health technology assessment organizations
Canadian Agency for Drugs and Technologies in Health (CADTH)	CA GOV	Yes	Yes	Yes	No	Yes	Yes
Haute Autorité de Santé (HAS)	FR GOV	Yes	Yes	Yes	No	Yes	Yes
Institute for Quality and Efficiency in Health Care (IQWIG)	GER GOV	Yes	Yes	No	No	Yes	Yes
National Institute for Health and Care Excellence (NICE)	UK GOV	No	No	No	No	Yes	Yes

* Peer-reviewed literature, government publications, primary data collection, confidential company report, etc., as data sources.

Abbreviations. CA, Canada; CL, clinical/professional organization; FR, France; GER, Germany; GOV, government; NP, non-profit; UA, unable to determine; UK, United Kingdom; US, United States.

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