Committees

Manuscript Review Committee

REG’s Manuscript Review Committee ensures all REG original research publications are consistent within and between each other. The Committee assume the role of REG within the study process, and describe real-life research data in a standard and meaningful way so as to aid reviewers and readers in their interpretation of the data. The committee have developed simple guidelines for the referencing of REG’s support; suggestions for consistency when describing the real-life data sources and methods used.

Pre-submission, the committee offer a light-touch (rapid) style review and, following publication, will collect and collate author’s feedback on any barriers they met (and solutions they implemented) on the path to publishing their REG / REG-supported study with a view to sharing learnings within the research community.

REG Study Parameters

REG studies fall into two key categories:

  • A study initiated and funded by REG
  • A study is conceived external to REG (e.g,. by a university research team), but receives REG support in the form of data provision; protocol review and development; expert input, analysis or funding

Manuscript Review Committee Process

The Committee’s process follows these key steps:

  • A copy of the REG Author Guidelines will be shared by the Publication Lead with the lead author of all REG abstracts accepted for conference presentation
  • Authors will incorporate the recommendations within their draft manuscripts
  • Pre-submission drafts of research papers will be sent to the Manuscript Review Committee to allow a light-touch review against REG author guidelines to be conducted within 10 days
  • Authors will be encouraged to incorporate the committee’s recommendations in their draft prior to submission
  • Following manuscript acceptance, paper authors will be asked to complete the short Manuscript Summary table

Author Guidelines

Title

  • Please note, some journals dislike use of “real-life” in study titles on the basis that all research is real-life

Author list

  • Include “on behalf of REG” if initiated and funded by REG
  • Include “in collaboration with” if investigator-initiated and REG-supported e.g. Andrew B Carter1 *, Deborah E Friend 1,2* § on behalf of (or in collaboration with) the Respiratory Effectiveness Group

Introduction / Background

  • Explain why the selected (real-life) study design is appropriate for the research question under consideration and how it will meet the proposed study objective
  • Place the study design into the Roche et al (Lancet Respir Med 2013;1:e29-30) research paradigm (ie, whether study is real life in terms of population, ecology of care, or both; see figure).

Methods

  • If a database study: include a description of the database
  • If not a database study (e.g. pragmatic randomised trial): describe in what respect it is a “real-life” study (e.g. in terms of study population, duration of follow up, ecology of care, etc), See Appendix for conceptual aids.
  • Include details of the (ENCePP, or other) registration number (if applicable)

Discussion

  • Consider the work in the context of the wider literature (referring to RCT and non-RCT evidence)
  • Interpret the results (where appropriate) on a population level, ie, what do these data mean for the practicing clinician, health economies, etc

Acknowledgements

  • Study carried out by REG, and funded through an REG research grant: ◦ no acknowledgement required
  • Study carried out by REG, and funded by specific supporter research grants, use the acknowledgement: ◦ Conducted by The Respiratory Effectiveness Group (REG; www.effectivenessevaluation.org) who received an unrestricted grant from [insert name of supporter / supporters] to carry out this research.
  • If REG was partially involved in the study (e.g. through data provision; analysis provision; publication support, etc) use: ◦ The Respiratory Effectiveness Group (REG; www.effectivenessevaluation.org) was responsible for the [insert REG’s role, e.g. data provision; analysis] of this study

Useful References

Roche N, Reddel HK, Agusti A, Bateman ED, Krishnan JA, Martin RJ, et al. Integrating real-life studies in the global therapeutic research framework. Lancet Respir Med 2013;1:e29-30

Roche N, Reddel H, Martin R, Brusselle G, Papi A, Thomas M, et al. Quality standards for real-world research. Focus on observational database studies of comparative effectiveness. Ann Am Thorac Soc 2014;11 Suppl 2:S99-S104.

Price D, Bateman ED, Chisholm A, Papadopoulos NG, Bosnic-Anticevich S, Pizzichini E, et al. Complementing the randomized controlled trial evidence base. Evolution not revolution. Ann Am Thorac Soc 2014;11 Suppl 2:S92-8.

Bartlett SJ, Barnes T, McIvor RA. Integrating patients into meaningful real-world research. Ann Am Thorac Soc 2014;11 Suppl 2:S112-7.

Campbell JD, McQueen RB, Briggs A. The “e” in cost-effectiveness analyses. A case study of omalizumab efficacy and effectiveness for cost-effectiveness analysis evidence. Ann Am Thorac Soc 2014;11 Suppl 2:S105-11.

Pinnock H, Epiphaniou E, Taylor SJ. Phase IV Implementation Studies. The Forgotten Finale to the Complex Intervention Methodology Framework. Ann Am Thorac Soc 2014;11 Suppl 2:S118-22.

Wong GW, Miravitlles M, Chisholm A, Krishnan J. Respiratory guidelines-which real world? Ann Am Thorac Soc 2014;11 Suppl 2:S85-91.

Please submit key details about your REG paper to help the REG Manuscript Review Committee maintain an up-to-date record of all REG published research. The record will serve as a means of ensuring no apparent (unexplained) contradictions between REG publications and will also serve as a means to collate information on journals that are “favourable” to real-life research submissions and common reviewer challenges (and successful solutions to such challenges) to help guide other REG collaborators in targeting appropriate journals and pre-empting and avoiding similar barriers to publications.

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