- Email: [email protected]
Turning the criticism into construction
DEPARTMENTS Journal of the American Pharmacists Association 56 (2016) 599e600
Contents lists available at ScienceDirect
Journal of the American Pharmacists Association journal homepage: www.japha.org
SCIENCE UPDATES
Turning the criticism into construction Patrick G. Clay
“By perseverance, the snail reached the ark.” (Charles Spurgeon) As HR 5921 and S3142 move toward becoming law, another piece of literature appears3 that provides a fresh perspective on the impact of pharmacistprovided services. This is now the third major review published since 2010.3-5 Consistent with previous reviews, the authors find overall that patient physiologic endpoints improved compared with usual care. Specifically, what does this latest review add? Pharmacist publications represented over 33,000 patients, interventions averaged nearly a year in duration, procedures listed interventional terms ranging from medication therapy management to medication reconciliation to medication monitoring, projects were delivered remotely as much as face-to-face, overwhelmingly used multiple “touches,” and measured goal attainment and appropriate medication use. What else did this review reinforce? As with an earlier evidence review,4 the methodologies deployed and the outcomes measured hamper the ability to extrapolate findings into clinical practice. Too few studies included “hard” endpoints, for example, costs and care access changes, and were assessed as having low bias. Looking beyond the superficial tables of findings and criticism of designs, a path to improving the pharmacist services literature is revealed. Let’s take a closer look at one aspect that pharmacists can use as a path to improvement. In the included studies where the latest authors3 interpreted pharmacists as “leading” at least one
component of patients’ disease management plans, clinical parameters such as glycemic control and lipid and blood pressure goals were more likely to be attained. However, the authors cited poor representation of outcome measures such as clinical events, mortality, patient satisfaction, harms incurred, and health care utilization. As pharmacists consider measures to use to demonstrate impact of services, inclusion of the latter would serve to bolster the meaningfulness of results. Furthermore, “leading” one component of a multifactorial care plan is not equivalent to being the ultimate decision maker for care plan direction. These authors placed outcomes squarely on the pharmacists if they were perceived to “lead” at least one component of the project. As is well known, leading a single component does not translate to overall decision authority (for the record, overall control of the medical plan is not being sought in either HR592 or S314). When there are specific aspects for which the pharmacists are completely responsible for a particular outcome(s), it should be well described in the analysis plan and clearly communicated in the publications. Failure to do so could continue to lead to those who interpret results wrongly assigning the pharmacist an inappropriate level of responsibility for overall outcomes. A second “critique” that serves to inform future design of interventional studies is bias in design and reporting.
Because many pharmacists struggle with obtaining support (both funding and time) to design, develop, and conduct more scientifically rigorous and clinically implementable projects, pilot projects represent a valid alternative to randomized clinical trials. An excellent review on how to minimize bias, demonstrate feasibility for larger-scale implementation, and appropriately reach conclusions based on the measured parameters is freely available.6 There is most definitely honor in publishing pilot studies in lieu of data that are immediately critiqued (dismissed even) for failing to deliver components they were never designed to provide. Finally, the purpose of the Greer et al. review was to determine effectiveness and harms of pharmacist-led chronic disease management for communitydwelling adults.3 The terms effectiveness and harm are not lightly used. A blueprint on how to design service evaluations to maximize likelihood of results being “accepted” are readily available in federally sponsored published guidelines.7 Pharmacists with the goal of demonstrating sufficient impact of their services to warrant compensation or institutional funding should take heed of how their final reports will be evaluated and to the degree possible incorporate that in the design. The changes necessary in the pharmacy literature will not come quickly or be easily achieved, and many will rightly feel as though progress is moving at the
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].
http://dx.doi.org/10.1016/j.japh.2016.08.001 1544-3191/© 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
DEPARTMENTS Patrick G.Clay / Journal of the American Pharmacists Association 56 (2016) 599e600
pace of a snail. This may be accurate, but take heart: Snails are 100 times faster than glaciers.
References 1. HR592dPharmacy and Medically Underserved Areas Enhancement Act, 114th Congress (20152016). Available at: http://www.congress.gov/ bill/114th-congress/house-bill/592. Accessed August 2, 2016. 2. S314dPharmacy and Medically Underserved Areas Enhancement Act, 114th Congress
600
(2015-2016). Available at: http://www.congress. gov/bill/114th-congress/senate-bill/314. Accessed August 2, 2016. 3. Greer N, Bolduc J, Geurkink E, et al. Pharmacistled chronic disease management: a systematic review of effectiveness and harms compared to usual care. Ann Int Med. 2016;165:30e40. 4. Viswanathan M, Kahwati LC, Golin CE, et al. Medication therapy management interventions in outpatient settings: a systematic review and meta-analysis. JAMA Intern Med. 2015;175: 76e87. 5. Chisholm-Burns MA, Kim Lee J, Spivey CA, et al. US pharmacists’ effect as team members on patient care: systematic review and meta-analyses. Med Care. 2010;48:923e933.
6. Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011;45:626e629. 7. Owens DK, Lohr KN, Atkins D, Treadwell JR, Reston JT, Bass EB, et al. AHRQ series paper 5: grading the strength of a body of evidence when comparing medical interventionsdAgency for Healthcare Research and Quality and the effective health-care program. J Clin Epidemiol. 2010;63:513e523.
Patrick G. Clay, PharmD, AAHIVP, CPI, FCCP, APhA Science Officer and Professor of Pharmacotherapy, College of Pharmacy, University of North Texas System, Fort Worth, TX
Contents lists available at ScienceDirect
Journal of the American Pharmacists Association journal homepage: www.japha.org
SCIENCE UPDATES
Turning the criticism into construction Patrick G. Clay
“By perseverance, the snail reached the ark.” (Charles Spurgeon) As HR 5921 and S3142 move toward becoming law, another piece of literature appears3 that provides a fresh perspective on the impact of pharmacistprovided services. This is now the third major review published since 2010.3-5 Consistent with previous reviews, the authors find overall that patient physiologic endpoints improved compared with usual care. Specifically, what does this latest review add? Pharmacist publications represented over 33,000 patients, interventions averaged nearly a year in duration, procedures listed interventional terms ranging from medication therapy management to medication reconciliation to medication monitoring, projects were delivered remotely as much as face-to-face, overwhelmingly used multiple “touches,” and measured goal attainment and appropriate medication use. What else did this review reinforce? As with an earlier evidence review,4 the methodologies deployed and the outcomes measured hamper the ability to extrapolate findings into clinical practice. Too few studies included “hard” endpoints, for example, costs and care access changes, and were assessed as having low bias. Looking beyond the superficial tables of findings and criticism of designs, a path to improving the pharmacist services literature is revealed. Let’s take a closer look at one aspect that pharmacists can use as a path to improvement. In the included studies where the latest authors3 interpreted pharmacists as “leading” at least one
component of patients’ disease management plans, clinical parameters such as glycemic control and lipid and blood pressure goals were more likely to be attained. However, the authors cited poor representation of outcome measures such as clinical events, mortality, patient satisfaction, harms incurred, and health care utilization. As pharmacists consider measures to use to demonstrate impact of services, inclusion of the latter would serve to bolster the meaningfulness of results. Furthermore, “leading” one component of a multifactorial care plan is not equivalent to being the ultimate decision maker for care plan direction. These authors placed outcomes squarely on the pharmacists if they were perceived to “lead” at least one component of the project. As is well known, leading a single component does not translate to overall decision authority (for the record, overall control of the medical plan is not being sought in either HR592 or S314). When there are specific aspects for which the pharmacists are completely responsible for a particular outcome(s), it should be well described in the analysis plan and clearly communicated in the publications. Failure to do so could continue to lead to those who interpret results wrongly assigning the pharmacist an inappropriate level of responsibility for overall outcomes. A second “critique” that serves to inform future design of interventional studies is bias in design and reporting.
Because many pharmacists struggle with obtaining support (both funding and time) to design, develop, and conduct more scientifically rigorous and clinically implementable projects, pilot projects represent a valid alternative to randomized clinical trials. An excellent review on how to minimize bias, demonstrate feasibility for larger-scale implementation, and appropriately reach conclusions based on the measured parameters is freely available.6 There is most definitely honor in publishing pilot studies in lieu of data that are immediately critiqued (dismissed even) for failing to deliver components they were never designed to provide. Finally, the purpose of the Greer et al. review was to determine effectiveness and harms of pharmacist-led chronic disease management for communitydwelling adults.3 The terms effectiveness and harm are not lightly used. A blueprint on how to design service evaluations to maximize likelihood of results being “accepted” are readily available in federally sponsored published guidelines.7 Pharmacists with the goal of demonstrating sufficient impact of their services to warrant compensation or institutional funding should take heed of how their final reports will be evaluated and to the degree possible incorporate that in the design. The changes necessary in the pharmacy literature will not come quickly or be easily achieved, and many will rightly feel as though progress is moving at the
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].
http://dx.doi.org/10.1016/j.japh.2016.08.001 1544-3191/© 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
DEPARTMENTS Patrick G.Clay / Journal of the American Pharmacists Association 56 (2016) 599e600
pace of a snail. This may be accurate, but take heart: Snails are 100 times faster than glaciers.
References 1. HR592dPharmacy and Medically Underserved Areas Enhancement Act, 114th Congress (20152016). Available at: http://www.congress.gov/ bill/114th-congress/house-bill/592. Accessed August 2, 2016. 2. S314dPharmacy and Medically Underserved Areas Enhancement Act, 114th Congress
600
(2015-2016). Available at: http://www.congress. gov/bill/114th-congress/senate-bill/314. Accessed August 2, 2016. 3. Greer N, Bolduc J, Geurkink E, et al. Pharmacistled chronic disease management: a systematic review of effectiveness and harms compared to usual care. Ann Int Med. 2016;165:30e40. 4. Viswanathan M, Kahwati LC, Golin CE, et al. Medication therapy management interventions in outpatient settings: a systematic review and meta-analysis. JAMA Intern Med. 2015;175: 76e87. 5. Chisholm-Burns MA, Kim Lee J, Spivey CA, et al. US pharmacists’ effect as team members on patient care: systematic review and meta-analyses. Med Care. 2010;48:923e933.
6. Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011;45:626e629. 7. Owens DK, Lohr KN, Atkins D, Treadwell JR, Reston JT, Bass EB, et al. AHRQ series paper 5: grading the strength of a body of evidence when comparing medical interventionsdAgency for Healthcare Research and Quality and the effective health-care program. J Clin Epidemiol. 2010;63:513e523.
Patrick G. Clay, PharmD, AAHIVP, CPI, FCCP, APhA Science Officer and Professor of Pharmacotherapy, College of Pharmacy, University of North Texas System, Fort Worth, TX