Difficulties in recruitment for a randomized controlled trial involving hysterosalpingography
Autor: | Denise A M Perquin, Anton J. M. de Craen, F.M. Helmerhorst |
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Jazyk: | angličtina |
Předmět: |
medicine.medical_specialty
Pediatrics medicine.diagnostic_test business.industry Research media_common.quotation_subject Medical record Public health Reproductive medicine Alternative medicine Obstetrics and Gynecology Fertility lcsh:Gynecology and obstetrics law.invention Randomized controlled trial Reproductive Medicine law Family medicine Obstetrics and Gynaecology medicine Hysterosalpingography Laparoscopy business lcsh:RG1-991 media_common |
Zdroj: | Reproductive Health, Vol 3, Iss 1, p 5 (2006) Reproductive Health |
ISSN: | 1742-4755 |
DOI: | 10.1186/1742-4755-3-5 |
Popis: | Background The usefulness of hysterosalpingography (HSG) as routine investigation in the fertility work-up prior to laparoscopy and dye had been assessed in a randomized controlled trial. Recruiting subjects to the study was more difficult than anticipated. The objective of this study was to explore possible reasons for non-participation in the trial. Methods All newly referred subfertile women admitted to the Reproductive Medicine Clinic of Leiden University Medical Centre between 1 April 1997 and 31 December 1999, were eligible for the study. The reasons for non-participation were evaluated by scrutinizing the medical records. Results Out of 759 women, a total of 127 (17%) agreed to participate in the trial. The most important reason for non-participation was because of exclusion criteria (73%). Other reasons were inattentive clinicians (3%) and patient-associated reasons (24%). Patient refusal and indecisiveness to enroll in the study were the most common patient-associated reasons. The most frequently stated reason for trial refusal was reluctance to undergo laparoscopy and dye mainly due to issues related to anesthesia and scheduling of procedure. Conclusion Almost three-quarters of recruitment difficulties in this study were due to unavoidable reasons. To overcome the remaining avoidable reasons for non-participation, attention should be paid to appropriate instruction of the study protocol to the participating doctors and to provide adequate information, in layman's terms, to the patients. Reminding patients by notes or telephone calls for attending the clinic are helpful. It may be contingent upon tracing the reasons of clinicians and patients for non-participation to improve enrollment during a trial. |
Databáze: | OpenAIRE |
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