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Implementing targeted expectant management in fertility care using prognostic modelling: a cluster randomized trial with a multifaceted strategy.
Hum Reprod 2017; 32(8):1648-1657HR

Abstract

STUDY QUESTION

What is the effectiveness of a multifaceted implementation strategy compared to usual care on improving the adherence to guideline recommendations on expectant management for couples with unexplained infertility?

SUMMARY ANSWER

The multifaceted implementation strategy did not significantly increase adherence to guideline recommendations on expectant management compared to care as usual.

WHAT IS KNOWN ALREADY

Intrauterine insemination (IUI) with or without ovarian hyperstimulation has no beneficial effect compared to no treatment for 6 months after the fertility work-up for couples with unexplained infertility and a good prognosis of natural conception. Therefore, various professionals and policy makers have advocated the use of prognostic profiles and expectant management in guideline recommendations.

STUDY DESIGN, SIZE, DURATION

A cluster randomized controlled trial in 25 clinics in the Netherlands was conducted between March 2013 and May 2014. Clinics were randomized between the implementation strategy (intervention, n = 13) and care as usual (control, n = 12). The effect of the implementation strategy was evaluated by comparing baseline and effect measurement data. Data collection was retrospective and obtained from medical record research and a patient questionnaire.

PARTICIPANTS/MATERIALS, SETTING, METHODS

A total of 544 couples were included at baseline and 485 at the effect measurement (247 intervention group/238 control group).

MAIN RESULTS AND THE ROLE OF CHANCE

Guideline adherence increased from 49 to 69% (OR 2.66; 95% CI 1.45-4.89) in the intervention group, and from 49 to 61% (OR 2.03; 95% CI 1.38-3.00) in the control group. Multilevel analysis with case-mix adjustment showed that the difference of 8% was not statistically significant (OR 1.31; 95% CI 0.67-2.59). The ongoing pregnancy rate within six months after fertility work-up did not significantly differ between intervention and control group (25% versus 27%: OR 0.72; 95% CI 0.40-1.27).

LIMITATIONS REASONS FOR CAUTION

There is a possible selection bias, couples included in the study had a higher socio-economic status than non-responders. How this affects guideline adherence is unclear. Furthermore, when powering for this study we did not take into account the unexpected improvement of adherence in the control group.

WIDER IMPLICATIONS OF THE FINDINGS

Generalization of our results to other countries with recommendations on expectant management might be questionable because barriers for expectant management can be very different in other countries. Furthermore, due to a large variation in improved adherence rate in the intervention group it will be interesting to further analyse the process of implementation in each clinic with a process evaluation on professionals and couples' exposure to and experiences with the strategy.

STUDY FUNDING/COMPETING INTEREST(S)

Supported by Netherlands Organisation for Health Research and Development (ZonMW, project number 171203005). No competing interests.

TRIAL REGISTRATION NUMBER

Dutch trial Register, www.trialregister.nl NTR3405.

TRIAL REGISTRATION DATE

19 April 2012.

DATE OF FIRST PATIENT'S ENROLMENT

10 July 2012.

Authors+Show Affiliations

Department of Obstetrics and Gynaecology, Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, The Netherlands.Department of Obstetrics and Gynaecology, Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, The Netherlands.Department of Obstetrics and Gynaecology, VU University Medical Center, University of Amsterdam, PO Box 7057, Amsterdam MB 1007, The Netherlands.Department of Obstetrics and Gynaecology, Catharina Medical Center, PO Box 1350, 5602ZA Eindhoven, The Netherlands.Department of Obstetrics and Gynaecology, Maxima Medical Center, PO Box 7777, 5500 MB Veldhoven, The Netherlands.Radboud Institute for Health Sciences, Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, The Netherlands.Department of Obstetrics and Gynaecology, OLVG (Oost), PO Box 95500, 1090 HM Amsterdam, The Netherlands.Department of Obstetrics and Gynaecology, Scheper Ziekenhuis, PO Box 30002, 7800 RA Emmen, The Netherlands.Department of Obstetrics and Gynaecology, Spaarne Ziekenhuis, PO Box 770, 2130 AT Hoofddorp, The Netherlands.Department of Obstetrics and Gynaecology, Kennemer Gasthuis, PO Box 417, 2026 BW Haarlem, The Netherlands.Department of Obstetrics and Gynaecology, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands.Centre for Reproductive Medicine, Academic Medical Centre, PO Box 22660, 1100 DD Amsterdam, The Netherlands.Department of Obstetrics and Gynaecology, Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, The Netherlands.School of Paediatrics and Reproductive Health, University of Adelaide, The Robinson Institute, 5005 SA Adelaide, Australia.Scientific institute for Quality of Healthcare, Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, The Netherlands.No affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28591847

Citation

Kersten, F A M., et al. "Implementing Targeted Expectant Management in Fertility Care Using Prognostic Modelling: a Cluster Randomized Trial With a Multifaceted Strategy." Human Reproduction (Oxford, England), vol. 32, no. 8, 2017, pp. 1648-1657.
Kersten FAM, Nelen WLDM, van den Boogaard NM, et al. Implementing targeted expectant management in fertility care using prognostic modelling: a cluster randomized trial with a multifaceted strategy. Hum Reprod. 2017;32(8):1648-1657.
Kersten, F. A. M., Nelen, W. L. D. M., van den Boogaard, N. M., van Rumste, M. M., Koks, C. A., IntHout, J., ... Hermens, R. P. G. M. (2017). Implementing targeted expectant management in fertility care using prognostic modelling: a cluster randomized trial with a multifaceted strategy. Human Reproduction (Oxford, England), 32(8), pp. 1648-1657. doi:10.1093/humrep/dex213.
Kersten FAM, et al. Implementing Targeted Expectant Management in Fertility Care Using Prognostic Modelling: a Cluster Randomized Trial With a Multifaceted Strategy. Hum Reprod. 2017 08 1;32(8):1648-1657. PubMed PMID: 28591847.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Implementing targeted expectant management in fertility care using prognostic modelling: a cluster randomized trial with a multifaceted strategy. AU - Kersten,F A M, AU - Nelen,W L D M, AU - van den Boogaard,N M, AU - van Rumste,M M, AU - Koks,C A, AU - IntHout,J, AU - Verhoeve,H R, AU - Pelinck,M J, AU - Boks,D E S, AU - Gianotten,J, AU - Broekmans,F J M, AU - Goddijn,M, AU - Braat,D D M, AU - Mol,B W J, AU - Hermens,R P G M, AU - ,, PY - 2016/12/08/received PY - 2017/05/19/accepted PY - 2017/6/8/pubmed PY - 2018/5/22/medline PY - 2017/6/8/entrez KW - expectant management KW - guideline adherence KW - implementation strategy KW - prognostic models KW - unexplained infertility SP - 1648 EP - 1657 JF - Human reproduction (Oxford, England) JO - Hum. Reprod. VL - 32 IS - 8 N2 - STUDY QUESTION: What is the effectiveness of a multifaceted implementation strategy compared to usual care on improving the adherence to guideline recommendations on expectant management for couples with unexplained infertility? SUMMARY ANSWER: The multifaceted implementation strategy did not significantly increase adherence to guideline recommendations on expectant management compared to care as usual. WHAT IS KNOWN ALREADY: Intrauterine insemination (IUI) with or without ovarian hyperstimulation has no beneficial effect compared to no treatment for 6 months after the fertility work-up for couples with unexplained infertility and a good prognosis of natural conception. Therefore, various professionals and policy makers have advocated the use of prognostic profiles and expectant management in guideline recommendations. STUDY DESIGN, SIZE, DURATION: A cluster randomized controlled trial in 25 clinics in the Netherlands was conducted between March 2013 and May 2014. Clinics were randomized between the implementation strategy (intervention, n = 13) and care as usual (control, n = 12). The effect of the implementation strategy was evaluated by comparing baseline and effect measurement data. Data collection was retrospective and obtained from medical record research and a patient questionnaire. PARTICIPANTS/MATERIALS, SETTING, METHODS: A total of 544 couples were included at baseline and 485 at the effect measurement (247 intervention group/238 control group). MAIN RESULTS AND THE ROLE OF CHANCE: Guideline adherence increased from 49 to 69% (OR 2.66; 95% CI 1.45-4.89) in the intervention group, and from 49 to 61% (OR 2.03; 95% CI 1.38-3.00) in the control group. Multilevel analysis with case-mix adjustment showed that the difference of 8% was not statistically significant (OR 1.31; 95% CI 0.67-2.59). The ongoing pregnancy rate within six months after fertility work-up did not significantly differ between intervention and control group (25% versus 27%: OR 0.72; 95% CI 0.40-1.27). LIMITATIONS REASONS FOR CAUTION: There is a possible selection bias, couples included in the study had a higher socio-economic status than non-responders. How this affects guideline adherence is unclear. Furthermore, when powering for this study we did not take into account the unexpected improvement of adherence in the control group. WIDER IMPLICATIONS OF THE FINDINGS: Generalization of our results to other countries with recommendations on expectant management might be questionable because barriers for expectant management can be very different in other countries. Furthermore, due to a large variation in improved adherence rate in the intervention group it will be interesting to further analyse the process of implementation in each clinic with a process evaluation on professionals and couples' exposure to and experiences with the strategy. STUDY FUNDING/COMPETING INTEREST(S): Supported by Netherlands Organisation for Health Research and Development (ZonMW, project number 171203005). No competing interests. TRIAL REGISTRATION NUMBER: Dutch trial Register, www.trialregister.nl NTR3405. TRIAL REGISTRATION DATE: 19 April 2012. DATE OF FIRST PATIENT'S ENROLMENT: 10 July 2012. SN - 1460-2350 UR - https://www.unboundmedicine.com/medline/citation/28591847/Implementing_targeted_expectant_management_in_fertility_care_using_prognostic_modelling:_a_cluster_randomized_trial_with_a_multifaceted_strategy_ L2 - https://academic.oup.com/humrep/article-lookup/doi/10.1093/humrep/dex213 DB - PRIME DP - Unbound Medicine ER -