On 2014 May 03, Gwinyai Masukume commented:

On the one hand, The Lancet seems serious about reducing research waste, but on the other hand it has restrictive policies that increase research waste.

“Journals should revise policies that restrict the number and timing of letters and other limitations on feedback”

“Letters for publication in the print journal must reach us within 2 weeks of publication of the original item and should be no longer than 250 words. Only one table or figure is permitted, and there should be no more than five references and five authors” [1]

Reference

[1] The Lancet. Information for Authors. [Internet]. 2014. [cited 1 May 2014]. Available from: http://download.thelancet.com/flatcontentassets/authors/lancet-information-for-authors.pdf

On 2014 Mar 01, Karen Woolley commented:

Professional medical writers: More haste, less waste

To paraphrase the paraphrased opening line of the much-needed paper by Glasziou et al.,¹

“The problem [with researchers who need, but don’t use, professional medical writing support] is long-standing, worldwide, pervasive, potentially serious, and not at all apparent to many researchers, peer-reviewers, journal editors, sponsors, and journalists.”

We, the members of the Global Alliance of Publication Professionals, congratulate Glasziou and his colleagues for highlighting the need for better reporting to help reduce research waste. We are surprised, however, that the authors did not explicitly recommend the use of professional medical writers (ie, those writers who are NOT ghostwriters).^2-5 If researchers used professional medical writers with more haste, we believe ¬─ and evidence suggests ─ there would be less research waste.

We readily acknowledge that some researchers don’t necessarily require professional writers. These researchers: - Write well - Are given adequate time to write - Follow journal guidelines - Are aware of, and adhere to, best-practice reporting guidelines - Keep up-to-date on regulations affecting medical writing practices - Expertly project manage themselves and their co-authors - Ensure disclosures are complete, etc...

Based on our collective experience of 100+ years of working with researchers around the world, however, not all researchers are so well-equipped. They (and the biomedical literature) could benefit greatly from the ethical, legitimate, and valuable support professional medical writers provide.⁶ Although evidence on the use of professional medical writers is embryonic, studies have shown that manuscripts with professional medical writing support are more compliant with CONSORT guidelines (especially reporting of harms),⁷ accepted more quickly for publication,⁸ and less likely to be retracted for misconduct,⁹ compared with those without writing support. A recent survey of authors also showed that 84% of authors valued the use of professional medical writers, with 1 in 3 viewing such support as extremely valuable.¹⁰

The cost of providing medical writing support has been calculated and is certainly affordable.⁶ Glasziou and his colleagues are correct that “a small proportion of core grant funding” should be dedicated to writing. Who should do this writing though...and, importantly, who has the time and expertise to do it quickly and do it well? A recent systematic review of 27 studies identified lack of time as the main reason researchers don’t write.¹¹ Professional medical writers have the advantage of being able to provide focused time, in addition to being able to provide the expertise to help authors prepare timely, high-quality reports. Indeed, writers who have passed a psychometrically validated exam to become a Certified Medical Publication Professional (CMPP) have had to prove their knowledge on 150 topics related to ethical and efficient medical writing practices.¹² Results from the Global Publication Survey (manuscript in preparation) will also reveal the extent of knowledge and guidance that professional medical writers provide to authors.

Like Glasziou et al., we support author training. We doubt, however, that every author who needs training will have the capacity, resources, or inclination to be trained. It can take years to become a great writer and it takes an increasing amount of time to keep abreast of best-practice reporting guidelines and regulations that affect writing. In the same way that professional statisticians help researchers who lack the time or expertise to analyse their data, professional medical writers can help researchers, who lack the time or expertise, to report their data. Today, biomedical research often requires a team effort and, given the need to improve results reporting, we believe (and evidence now suggests) that professional medical writers should be trusted and valued members of these teams. The time to recognise and use professional medical writers is now – those who act with haste should incur less waste.

Authors and affiliations

Karen L. Woolley PhD CMPP,a Art Gertel MS,b Cindy Hamilton PharmD,c Adam Jacobs PhD,d Jackie Marchington PhD CMPPe (Global Alliance of Publication Professionals; www.gappteam.org)

a. Divisional Lead. ProScribe – Envision Pharma Group; Adjunct Professor, University of the Sunshine Coast, Australia. b. VP, Regulatory and Medical Affairs, TFS, Inc.. USA; Senior Research Fellow, CIRS. c. Assistant Clinical Professor, Virginia Commonwealth University School of Pharmacy; Principal, Hamilton House, USA. d. Director, Dianthus Medical Limited, UK. e. Director of Scientific Operations, Caudex Medical, UK.

Disclosures

All authors declare that: (1) all authors have or do provide ethical medical writing services to academic, biotechnology, or pharmaceutical clients; (2) KW’s husband is also an employee of ProScribe – Envision Pharma Group; all other authors’ spouses, partners, or children have no financial relationships that may be relevant to the submitted work; and (3) all authors are active in national and international not-for-profit associations that encourage ethical medical writing practices. No external sponsors were involved in this study and no external funding was used.

References

1. Glasziou P, Altman DG, Bossuyt P et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet 2014; 383:267-276.
2. Woolley KL. Goodbye Ghostwriters!: How to work ethically and efficiently with professional medical writers. Chest 2006;130:921-923.
3. Woolley KL, Gertel A, Hamilton C, Snyder G, Jacobs A (GAPP). Don’t Be a Fool – Don’t Use Fool’s Gold. Am J Med 2012; 125:e21–e22.
4. Gøtzsche PC, Kassirer JP, Woolley KL, et al., What should be done to tackle ghostwriting in the medical literature? PLoS Med. 2009;6(2):e1000023.
5. Hamilton C, (GAPP). Differential diagnosis: Distinguishing between ghostwriting and professional medical writing in biomedical journals. JAMA Intern Med 2013;173(22):2091-2092.<br>
6. Woolley KL, Gertel A, Hamilton C, Jacobs A, Snyder G (GAPP). Poor compliance with reporting research results – we know it’s a problem…how do we fix it? Curr Med Res Opin 2012;28:1857-1860.
7. Jacobs A. Adherence to the CONSORT guideline in papers written by professional medical writers. Write Stuff. 2010;19:196-200.
8. Bailey M. Science editing and its effect on manuscript acceptance time. AMWA Journal. 2011;26(4):147-152.
9. Woolley KL, Lew RA, Stretton S, et al. Lack of involvement of medical writers and the pharmaceutical industry in publications retracted for misconduct: a systematic, controlled, retrospective study. Curr Med Res Opin. 2011;27:1175-1182.
10. Marchington J, Burd G, Kidd C. Author attitudes to professional medical writing support. Curr Med Res Opin 2013;29:S17.
11. Scherer RW, Ugarte-Gil C. Authors’ reasons for unpublished research presented at biomedical conferences: A systematic review. http://www.peerreviewcongress.org/abstracts_2013.html#1 Accessed 27 February 2014.
12. Woolley KL. Coincidence? Publication expertise boosts publication output. J Surg Educ 2014 71:7.

On 2014 Feb 10, Paul Glasziou commented:

Dear Ginny,

We certainly agree that, even after full publication of a well designed study set in the context of a systematic review of similar studies, poor access is a subsequent form of waste. We should have been more careful to highlight out that our analysis only extended to the point of publication. We did not address the problems of subsequent waste that occurs because of closed access , lack of translation, poor findability, and other problems with the dissemination and use of research. Our original 2009 model (question, design, publication, and reporting quality) represents only a halfway point along the chain from clinical uncertainty to patient benefit. Some of the current authors aim to pursue this subsequent half, but have realized it is more complex and messy than in our previous "awareness to action" pipeline(1). Multi-language, findable, and freely accessible research reports are clearly an important starting point in that chain.

Paul Glasziou

(1) Glasziou P, Haynes B. The paths from research to improved health outcomes. ACP J Club. 2005 Mar-Apr;142(2):A8-10.

On 2014 Feb 07, Ginny Barbour commented:

Among the important topics that Paul Glasziou and colleagues address in the Lancet series on waste in research, of which this is one paper, the key issue of access to published knowledge receives little mention. More than 10 years after Open Access publishing became widely available, lack of awareness persists concerning its potential to reduce waste, as does confusion over the difference between open and free access. Iain Chalmers inadvertently highlighted this in his tweet about the series.

Iain Chalmers (@iainchalmersTTi) 1/9/14, 5:34 AM Open access Lancet series on reducing waste in pre-clinical, clinical and epidemiological research thelancet.com/series/research

We thought it would be useful to clarify the differences illustrated by this example. Free access means: the article is free to read; it may not be reused (including translated) without permission; authors and readers may be charged for copying the article, and authors may be prohibited from posting their article on an institutional server. “Free” rights may be withdrawn at any time by the publisher, as occurred with the QUOROM paper on reporting of meta-analyses Moher D, 1999. This was published in the Lancet in 1999, was originally made free but was subsequently placed behind a paywall (but which since the time of the writing and submission – and rejection – of this comment to the Lancet has become freely available again, with no indication if it is a permanent state).

Open Access is defined as: free, immediate access online; unrestricted distribution and re-use rights in perpetuity for humans and technological applications; author(s) retains rights to attribution; papers are immediately deposited in a public online archive, such as PubMed Central. These principles, backed up by internationally accepted licenses from Creative Commons, means in practice that anything published Open Access can be read and reused in perpetuity by both humans and machines.

The Lancet Series is “Copyright © 2014 Elsevier Ltd All rights reserved”. At the time of publication it was necessary to login to read the articles. It is, therefore, free, not Open Access.

We hope that future articles in this important endeavour will address the need for open, not just free, access, and will themselves be Open Access.

Conflict of Interest. Both authors are employed by PLOS, an Open Access publisher.

Virginia Barbour, Medicine Editorial Director, PLOS Larry Peiperl, Chief Editor, PLOS Medicine, PLOS

1160 Battery Street Koshland Building East, Ste. 100 San Francisco, CA 94111 US

On 2014 Feb 07, Ginny Barbour commented:

Among the important topics that Paul Glasziou and colleagues address in the Lancet series on waste in research, of which this is one paper, the key issue of access to published knowledge receives little mention. More than 10 years after Open Access publishing became widely available, lack of awareness persists concerning its potential to reduce waste, as does confusion over the difference between open and free access. Iain Chalmers inadvertently highlighted this in his tweet about the series.

Iain Chalmers (@iainchalmersTTi) 1/9/14, 5:34 AM Open access Lancet series on reducing waste in pre-clinical, clinical and epidemiological research thelancet.com/series/research

We thought it would be useful to clarify the differences illustrated by this example. Free access means: the article is free to read; it may not be reused (including translated) without permission; authors and readers may be charged for copying the article, and authors may be prohibited from posting their article on an institutional server. “Free” rights may be withdrawn at any time by the publisher, as occurred with the QUOROM paper on reporting of meta-analyses Moher D, 1999. This was published in the Lancet in 1999, was originally made free but was subsequently placed behind a paywall (but which since the time of the writing and submission – and rejection – of this comment to the Lancet has become freely available again, with no indication if it is a permanent state).

Open Access is defined as: free, immediate access online; unrestricted distribution and re-use rights in perpetuity for humans and technological applications; author(s) retains rights to attribution; papers are immediately deposited in a public online archive, such as PubMed Central. These principles, backed up by internationally accepted licenses from Creative Commons, means in practice that anything published Open Access can be read and reused in perpetuity by both humans and machines.

The Lancet Series is “Copyright © 2014 Elsevier Ltd All rights reserved”. At the time of publication it was necessary to login to read the articles. It is, therefore, free, not Open Access.

We hope that future articles in this important endeavour will address the need for open, not just free, access, and will themselves be Open Access.

Conflict of Interest. Both authors are employed by PLOS, an Open Access publisher.

Virginia Barbour, Medicine Editorial Director, PLOS Larry Peiperl, Chief Editor, PLOS Medicine, PLOS

1160 Battery Street Koshland Building East, Ste. 100 San Francisco, CA 94111 US

On 2014 Feb 10, Paul Glasziou commented:

Dear Ginny,

We certainly agree that, even after full publication of a well designed study set in the context of a systematic review of similar studies, poor access is a subsequent form of waste. We should have been more careful to highlight out that our analysis only extended to the point of publication. We did not address the problems of subsequent waste that occurs because of closed access , lack of translation, poor findability, and other problems with the dissemination and use of research. Our original 2009 model (question, design, publication, and reporting quality) represents only a halfway point along the chain from clinical uncertainty to patient benefit. Some of the current authors aim to pursue this subsequent half, but have realized it is more complex and messy than in our previous "awareness to action" pipeline(1). Multi-language, findable, and freely accessible research reports are clearly an important starting point in that chain.

Paul Glasziou

(1) Glasziou P, Haynes B. The paths from research to improved health outcomes. ACP J Club. 2005 Mar-Apr;142(2):A8-10.

On 2014 Mar 01, Karen Woolley commented:

Professional medical writers: More haste, less waste

To paraphrase the paraphrased opening line of the much-needed paper by Glasziou et al.,¹

“The problem [with researchers who need, but don’t use, professional medical writing support] is long-standing, worldwide, pervasive, potentially serious, and not at all apparent to many researchers, peer-reviewers, journal editors, sponsors, and journalists.”

We, the members of the Global Alliance of Publication Professionals, congratulate Glasziou and his colleagues for highlighting the need for better reporting to help reduce research waste. We are surprised, however, that the authors did not explicitly recommend the use of professional medical writers (ie, those writers who are NOT ghostwriters).^2-5 If researchers used professional medical writers with more haste, we believe ¬─ and evidence suggests ─ there would be less research waste.

We readily acknowledge that some researchers don’t necessarily require professional writers. These researchers: - Write well - Are given adequate time to write - Follow journal guidelines - Are aware of, and adhere to, best-practice reporting guidelines - Keep up-to-date on regulations affecting medical writing practices - Expertly project manage themselves and their co-authors - Ensure disclosures are complete, etc...

Based on our collective experience of 100+ years of working with researchers around the world, however, not all researchers are so well-equipped. They (and the biomedical literature) could benefit greatly from the ethical, legitimate, and valuable support professional medical writers provide.⁶ Although evidence on the use of professional medical writers is embryonic, studies have shown that manuscripts with professional medical writing support are more compliant with CONSORT guidelines (especially reporting of harms),⁷ accepted more quickly for publication,⁸ and less likely to be retracted for misconduct,⁹ compared with those without writing support. A recent survey of authors also showed that 84% of authors valued the use of professional medical writers, with 1 in 3 viewing such support as extremely valuable.¹⁰

The cost of providing medical writing support has been calculated and is certainly affordable.⁶ Glasziou and his colleagues are correct that “a small proportion of core grant funding” should be dedicated to writing. Who should do this writing though...and, importantly, who has the time and expertise to do it quickly and do it well? A recent systematic review of 27 studies identified lack of time as the main reason researchers don’t write.¹¹ Professional medical writers have the advantage of being able to provide focused time, in addition to being able to provide the expertise to help authors prepare timely, high-quality reports. Indeed, writers who have passed a psychometrically validated exam to become a Certified Medical Publication Professional (CMPP) have had to prove their knowledge on 150 topics related to ethical and efficient medical writing practices.¹² Results from the Global Publication Survey (manuscript in preparation) will also reveal the extent of knowledge and guidance that professional medical writers provide to authors.

Like Glasziou et al., we support author training. We doubt, however, that every author who needs training will have the capacity, resources, or inclination to be trained. It can take years to become a great writer and it takes an increasing amount of time to keep abreast of best-practice reporting guidelines and regulations that affect writing. In the same way that professional statisticians help researchers who lack the time or expertise to analyse their data, professional medical writers can help researchers, who lack the time or expertise, to report their data. Today, biomedical research often requires a team effort and, given the need to improve results reporting, we believe (and evidence now suggests) that professional medical writers should be trusted and valued members of these teams. The time to recognise and use professional medical writers is now – those who act with haste should incur less waste.

Authors and affiliations

Karen L. Woolley PhD CMPP,a Art Gertel MS,b Cindy Hamilton PharmD,c Adam Jacobs PhD,d Jackie Marchington PhD CMPPe (Global Alliance of Publication Professionals; www.gappteam.org)

a. Divisional Lead. ProScribe – Envision Pharma Group; Adjunct Professor, University of the Sunshine Coast, Australia. b. VP, Regulatory and Medical Affairs, TFS, Inc.. USA; Senior Research Fellow, CIRS. c. Assistant Clinical Professor, Virginia Commonwealth University School of Pharmacy; Principal, Hamilton House, USA. d. Director, Dianthus Medical Limited, UK. e. Director of Scientific Operations, Caudex Medical, UK.

Disclosures

All authors declare that: (1) all authors have or do provide ethical medical writing services to academic, biotechnology, or pharmaceutical clients; (2) KW’s husband is also an employee of ProScribe – Envision Pharma Group; all other authors’ spouses, partners, or children have no financial relationships that may be relevant to the submitted work; and (3) all authors are active in national and international not-for-profit associations that encourage ethical medical writing practices. No external sponsors were involved in this study and no external funding was used.

References

1. Glasziou P, Altman DG, Bossuyt P et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet 2014; 383:267-276.
2. Woolley KL. Goodbye Ghostwriters!: How to work ethically and efficiently with professional medical writers. Chest 2006;130:921-923.
3. Woolley KL, Gertel A, Hamilton C, Snyder G, Jacobs A (GAPP). Don’t Be a Fool – Don’t Use Fool’s Gold. Am J Med 2012; 125:e21–e22.
4. Gøtzsche PC, Kassirer JP, Woolley KL, et al., What should be done to tackle ghostwriting in the medical literature? PLoS Med. 2009;6(2):e1000023.
5. Hamilton C, (GAPP). Differential diagnosis: Distinguishing between ghostwriting and professional medical writing in biomedical journals. JAMA Intern Med 2013;173(22):2091-2092.<br>
6. Woolley KL, Gertel A, Hamilton C, Jacobs A, Snyder G (GAPP). Poor compliance with reporting research results – we know it’s a problem…how do we fix it? Curr Med Res Opin 2012;28:1857-1860.
7. Jacobs A. Adherence to the CONSORT guideline in papers written by professional medical writers. Write Stuff. 2010;19:196-200.
8. Bailey M. Science editing and its effect on manuscript acceptance time. AMWA Journal. 2011;26(4):147-152.
9. Woolley KL, Lew RA, Stretton S, et al. Lack of involvement of medical writers and the pharmaceutical industry in publications retracted for misconduct: a systematic, controlled, retrospective study. Curr Med Res Opin. 2011;27:1175-1182.
10. Marchington J, Burd G, Kidd C. Author attitudes to professional medical writing support. Curr Med Res Opin 2013;29:S17.
11. Scherer RW, Ugarte-Gil C. Authors’ reasons for unpublished research presented at biomedical conferences: A systematic review. http://www.peerreviewcongress.org/abstracts_2013.html#1 Accessed 27 February 2014.
12. Woolley KL. Coincidence? Publication expertise boosts publication output. J Surg Educ 2014 71:7.

On 2014 May 03, Gwinyai Masukume commented:

On the one hand, The Lancet seems serious about reducing research waste, but on the other hand it has restrictive policies that increase research waste.

“Journals should revise policies that restrict the number and timing of letters and other limitations on feedback”

“Letters for publication in the print journal must reach us within 2 weeks of publication of the original item and should be no longer than 250 words. Only one table or figure is permitted, and there should be no more than five references and five authors” [1]

Reference

[1] The Lancet. Information for Authors. [Internet]. 2014. [cited 1 May 2014]. Available from: http://download.thelancet.com/flatcontentassets/authors/lancet-information-for-authors.pdf