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Do you want to matter?
DEPARTMENTS Journal of the American Pharmacists Association 57 (2017) 755
Contents lists available at ScienceDirect
Journal of the American Pharmacists Association journal homepage: www.japha.org
SCIENCE UPDATES
Do you want to matter? Patrick G. Clay
Earlier this month a manuscript describing the positive clinical outcomes in patients after receiving clinic-based, pharmacist-delivered, direct patient care services was published.1 It was a pilot program. It was prospectively performed, participants were randomized, a matched control group was retrospectively identified from the population of the study sites, used a published medication therapy management (MTM) approach,2 and provided a procedure table. As has been demonstrated many times previously, the primary clinical outcome, a clinically and statistically significant improvement in HbA1C, was attained (P < 0.05). The authors assert that the results were the result of the intervention by the pharmacists, and indeed, that certainly appears to be the case. Here is the challenge: would this manuscript be included in future systematic reviews and meta-analyses, or would it be excluded? To be included in higher-level analyses, certain elements are required to be included in the manuscript itself. These elements are detailed in the accepted reporting guidelines that depend on the type of research conducted.3,4 For every possible variation of research, there is either an established guideline that has been well accepted (CONSORT [Consolidated Standards of Reporting Trials], STROBE [Strengthening the Reporting of Observational Studies in Epidemiology], PRISMA [Preferred Reporting Items for Systematic Reviews and Meta-analyses], etc.) or best practice is recommended (AGREE [Appraisal of Guidelines for Research and Evaluation], RIGHT [Essential Reporting Items for Practice Guidelines in Healthcare], etc.). For this particular manuscript, a pilot controlled clinical trial, both the CONSORT4 and the
CONSORT extension for randomized pilot and feasibility trials are applicable.5 Of these guides, only one (CONSORT) was available before this pilot project was designed and conducted. Reviewing the pharmacists’ publication against the guideline that was in effect at the time of study design (CONSORT), there are a number of requirements that were not clearly described in the final manuscript. Consequently, this would likely result in the valuable and important results generated being left out of future systematic reviews and Agency for Healthcare Research and Quality expert panel reports on MTM. Okay, so what is a researcher to do? Journals restrict word counts, figures, etc., yet the reporting requirements ding manuscripts that fail to check every box. The answer is not easily provided. Because data such as these are critical to continually demonstrate the value of pharmacists, authors should push to have journals permit additional, online-only appendices that clearly and fully address the applicable reporting guidelines criteria. Many journals, such as JAPhA, provide these very criteria in the instructions to authors sections on their websites, and researchers should include them along with their publications to further justify their request for inclusion of appendices. Importantly, researchers should also use these final reporting requirements when designing
studies to ensure that the elements are not just included but captured in such a way that they become reportable. Do not let the many hours and all the blood, sweat, and tears of conducting human research be left on the cutting floor (to borrow a phrase from the film industry). Make it matterdour patients deserve nothing less. References 1. Ndefo UA, Moultry AM, Davis PN, Askew R. Provision of medication therapy management by pharmacists to patients with type-2 diabetes mellitus in a federally qualified health center. P T. 2017;42:632e637. 2. Moulty AM, ed. Implementation of a medication therapy management intervention in ambulatory care settings: experiences and lessons learned from the MyRx pilot program. AHRQ September 2016. Available at: https:// innovations.ahrq.gov/sites/default/files/experi ences_and_lessons_learned_from_the_myrx_ pilot.pdf. Accessed October 15, 2017. 3. EQUATOR Network. Enhancing the quality and transparency of health research. Available at: http://www.equator-network.org/. Accessed October 17, 2017. 4. Eldridge SM, Chan CL, Campbell MJ, et al. PAFS Consensus Group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355:i5239. 5. Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. Patrick G. Clay, PharmD, AAHIVP, FCCP, CCTI, Professor of Pharmacotherapy, College of Pharmacy, University of North Texas System, Fort Worth, TX; and APhA Science Officer
The Science Updates column highlights research published in journals other than JAPhA that is of interest to the Journal's readership. APhA members who have published research are encouraged to forward the PubMed citation, or an electronic version of their article, as soon as they appear or ahead of print, to Contributing Editor Patrick G. Clay, PharmD, AAHIVP, CPI, FCCP at [email protected].
https://doi.org/10.1016/j.japh.2017.10.010 1544-3191/© 2017 Published by Elsevier Inc. on behalf of the American Pharmacists Association.
Contents lists available at ScienceDirect
Journal of the American Pharmacists Association journal homepage: www.japha.org
SCIENCE UPDATES
Do you want to matter? Patrick G. Clay
Earlier this month a manuscript describing the positive clinical outcomes in patients after receiving clinic-based, pharmacist-delivered, direct patient care services was published.1 It was a pilot program. It was prospectively performed, participants were randomized, a matched control group was retrospectively identified from the population of the study sites, used a published medication therapy management (MTM) approach,2 and provided a procedure table. As has been demonstrated many times previously, the primary clinical outcome, a clinically and statistically significant improvement in HbA1C, was attained (P < 0.05). The authors assert that the results were the result of the intervention by the pharmacists, and indeed, that certainly appears to be the case. Here is the challenge: would this manuscript be included in future systematic reviews and meta-analyses, or would it be excluded? To be included in higher-level analyses, certain elements are required to be included in the manuscript itself. These elements are detailed in the accepted reporting guidelines that depend on the type of research conducted.3,4 For every possible variation of research, there is either an established guideline that has been well accepted (CONSORT [Consolidated Standards of Reporting Trials], STROBE [Strengthening the Reporting of Observational Studies in Epidemiology], PRISMA [Preferred Reporting Items for Systematic Reviews and Meta-analyses], etc.) or best practice is recommended (AGREE [Appraisal of Guidelines for Research and Evaluation], RIGHT [Essential Reporting Items for Practice Guidelines in Healthcare], etc.). For this particular manuscript, a pilot controlled clinical trial, both the CONSORT4 and the
CONSORT extension for randomized pilot and feasibility trials are applicable.5 Of these guides, only one (CONSORT) was available before this pilot project was designed and conducted. Reviewing the pharmacists’ publication against the guideline that was in effect at the time of study design (CONSORT), there are a number of requirements that were not clearly described in the final manuscript. Consequently, this would likely result in the valuable and important results generated being left out of future systematic reviews and Agency for Healthcare Research and Quality expert panel reports on MTM. Okay, so what is a researcher to do? Journals restrict word counts, figures, etc., yet the reporting requirements ding manuscripts that fail to check every box. The answer is not easily provided. Because data such as these are critical to continually demonstrate the value of pharmacists, authors should push to have journals permit additional, online-only appendices that clearly and fully address the applicable reporting guidelines criteria. Many journals, such as JAPhA, provide these very criteria in the instructions to authors sections on their websites, and researchers should include them along with their publications to further justify their request for inclusion of appendices. Importantly, researchers should also use these final reporting requirements when designing
studies to ensure that the elements are not just included but captured in such a way that they become reportable. Do not let the many hours and all the blood, sweat, and tears of conducting human research be left on the cutting floor (to borrow a phrase from the film industry). Make it matterdour patients deserve nothing less. References 1. Ndefo UA, Moultry AM, Davis PN, Askew R. Provision of medication therapy management by pharmacists to patients with type-2 diabetes mellitus in a federally qualified health center. P T. 2017;42:632e637. 2. Moulty AM, ed. Implementation of a medication therapy management intervention in ambulatory care settings: experiences and lessons learned from the MyRx pilot program. AHRQ September 2016. Available at: https:// innovations.ahrq.gov/sites/default/files/experi ences_and_lessons_learned_from_the_myrx_ pilot.pdf. Accessed October 15, 2017. 3. EQUATOR Network. Enhancing the quality and transparency of health research. Available at: http://www.equator-network.org/. Accessed October 17, 2017. 4. Eldridge SM, Chan CL, Campbell MJ, et al. PAFS Consensus Group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355:i5239. 5. Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. Patrick G. Clay, PharmD, AAHIVP, FCCP, CCTI, Professor of Pharmacotherapy, College of Pharmacy, University of North Texas System, Fort Worth, TX; and APhA Science Officer
The Science Updates column highlights research published in journals other than JAPhA that is of interest to the Journal's readership. APhA members who have published research are encouraged to forward the PubMed citation, or an electronic version of their article, as soon as they appear or ahead of print, to Contributing Editor Patrick G. Clay, PharmD, AAHIVP, CPI, FCCP at [email protected].
https://doi.org/10.1016/j.japh.2017.10.010 1544-3191/© 2017 Published by Elsevier Inc. on behalf of the American Pharmacists Association.