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Published Online, 3 March 2009, www.theannals.com, DOI 10.1345/aph.1K635b.
The Annals of Pharmacotherapy: Vol. 43, No. 3, pp. 551. DOI 10.1345/aph.1K635b
© 2009 Harvey Whitney Books Company.
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Authors' Reply

Wolfgang Hoffmann, MD MPH

Director Institute of Community Medicine University of Greifswald, Ellernholzstr. 1-2 17487 Greifswald, Germany fax +49 3834/867751 wolfgang.hoffmann{at}uni-greifswald.de

Thomas Fiß

Student Institute of Community Medicine University of Greifswald

Katrin Janhsen, PhD

Scientific Employee Centre for Social Policy Research University of Bremen Bremen, Germany

Published Online, March 3, 2009. www.theannals.com, DOI 10.1345/aph.1K635b


We have read with interest the comments of Gagne and Maio on our article. In this study we conducted a randomized, prospective pharmaceutical care study in a community-based setting. After a 4-month intervention period, several parameters (days with headache, intensity of untreated pain, patients' self-efficacy) had improved significantly in both the intervention and control groups. Systematic differences between the intervention and control groups concerned self-efficacy and mental health, with only the latter reaching statistical significance.

Gagne and Maio's criticism focuses on our findings for self-efficacy and mental health. We agree that the significant improvement of self-efficacy in the intervention group is counterbalanced to a considerable degree by a parallel improvement in the control group. We also agree that the limited absolute difference in the improvement between the 2 groups and the fact that the statistical test for a systematic difference was nonsignificant leave ample space to debate; in light of this criticism, we concede that the wording in our abstract could, or probably should, have been more cautious.

Regarding mental health, we find Gagne and Maio's argument difficult to follow. While there is also an improvement in both groups, the difference is considerably more pronounced in the intervention group than in the control group and reaches statistical significance only in the former. The systematic difference of 1.78 points is statistically significant in a formal U test. This improvement is accompanied by rather positive subjective accounts that we solicited in the interviews, but we did not attempt to discuss clinical significance in quantitative terms in the context of this proof-of-principle study.

Much of our article is devoted to a discussion of the many limitations of this study, which nevertheless is one of the few studies that has tried to systematically assess the effect of pharmaceutical care in a prospective, community-based design. However, in terms of measuring, comparing, and reporting the outcomes, our study has so far set a standard.

Hence, while we agree with some of the criticism, we do not concur with Gagne and Maio's fundamental verdict. As we have stressed in our discussion, future studies will require several improvements, including an extended intervention time and an increased number of patients. With Gagne and Maio's comments, we can add continuous improvement of the programs to this list.

Further research, as well as discussion, is required before effective instruments and strategies for pharmaceutical care can be developed and implemented in every pharmacy.





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