Friday, March 25, 2011

A multi-faceted strategy to improve the use of national fertility guidelines; a cluster-randomized controlled trial

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Selma M. Mourad1,2, Rosella P.M.G. Hermens2, Janine Liefers2, Reinier P. Akkermans2, G.A. Zielhuis3, E. Adang3, Richard P.T.M. Grol2, Willianne L.D.M. Nelen1 and Jan A.M. Kremer1,*
1Department of Obstetrics and Gynecology, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, The Netherlands
2Scientific Institute for Quality of Healthcare (IQ Healthcare), Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, The Netherlands
3Department of Epidemiology, Biostatistics and Health Technology Assessment, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, The Netherlands *Correspondence address. E-mail: j.kremer{at}obgyn.umcn.nlReceived February 2, 2010. Revision received August 9, 2010. Accepted September 30, 2010. BACKGROUND Proper use of clinical practice guidelines can decrease variation in care between settings. However, actual use of fertility guidelines is suboptimal and in need of improvement. Hence, a cluster-randomized controlled trial was designed to study the effects of two strategies to implement national Dutch guidelines on comprehensive fertility care.

METHODS Sixteen fertility clinics participated in the trial. A minimal, professional-oriented implementation strategy of audit and feedback was tested versus a maximal multi-faceted strategy that was both professional and patient oriented. The extent of adherence to guideline recommendations, reflected in quality indicator scores, was the primary outcome measure. To gain an insight into unwanted side effects, patient anxiety and depression scores were gathered as secondary outcomes. Data collection encompassed medical record search, patient and professional questionnaires.

RESULTS A total of 1499 couples were included at baseline and 1396 at the after-measurement. No overall significant improvement in indicator scores was found for either strategy [odds ratios ranging from 0.23 (95% confidence interval (CI): 0.06–0.95) to 6.66 (95% CI: 0.33–132.8]. Secondary outcomes did not differ significantly for both groups, although selected anxiety scores appeared lower in the maximal intervention group. Process evaluation of the trial revealed positive patient experiences with the intervention material [e.g. an increased understanding of their doctor's treatment policy (61%), an increased ability to ask questions about the treatment (61%)]. Professionals’ appreciation of intervention elements varied, and execution of the multi-faceted strategy appeared incomplete.

DISCUSSION Absence of an intervention effect may be due to the nature of the strategies, incomplete execution or flaws in study design. Process evaluation data raise the question of whether professionals should be the only stakeholder responsible for guideline implementation. This study therefore contributes to an increased understanding of fertility guideline implementation in general, and the role of patients in particular.

Clinical Trials.gov: NCT00119925.

© The Author 2010. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org This ArticleHum. Reprod. (2011) 26 (4): 817-826. doi: 10.1093/humrep/deq299 First published online: December 6, 2010

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