Acceptability of an experimental intracervical device: results of a study controlling for selection bias. 1989

R N Shain, and K Ratsula, and J Toivonen, and P Lähteenmäki, and T Luukkainen, and A E Holden, and M Rosenthal
Department of Obstetrics and Gynecology, University of Texas Health Science Center, San Antonio 78284.

We analyzed baseline and 12-month follow-up interview data from 98 women who had volunteered to use an experimental intracervical device (ICD) and from 155 women who had been randomly assigned to two control groups, the levonorgestrel-releasing intrauterine device (LNG-IUD; N = 86) and the copper Nova-T IUD (N = 69). All participants were clinic patients in Helsinki, Finland. Initial analysis of 12-month discontinuation data indicated that a significantly higher percent of ICD users (22.4) discontinued their device than did either LNG-IUD (7.0) or Nova-T (8.7) users. However, we were no longer able to detect significant differences in discontinuation after controlling for baseline variables that assessed predisposition to be dissatisfied with contraception in general. Adjusted probabilities of discontinuing the ICD, LNG-IUD, and Nova-T were 11.8%, 6.2% and 7.9%, respectively. These data indicate that the ICD is likely to be acceptable to Helsinki clinic patients; moreover, they suggest a definite place for hormonal intrauterine devices in the contraceptive armamentarium. Most importantly, the methodology used here can be generalized to acceptability studies of other contraceptive devices and drugs undergoing Phase I and early Phase II clinical trials (in situations where randomization may not be feasible) in order to identify and control for the bias introduced by nonrandom assignment procedures.

UI MeSH Term Description Entries
D007435 Intrauterine Devices, Copper Intrauterine contraceptive devices that depend on the release of metallic copper. Copper Intrauterine Devices,Copper-Releasing IUDs,IUD, Copper Releasing,Copper Intrauterine Device,Copper Releasing IUD,Copper-Releasing IUD,Device, Copper Intrauterine,Devices, Copper Intrauterine,IUD, Copper-Releasing,IUDs, Copper-Releasing,Intrauterine Device, Copper
D007436 Intrauterine Devices, Medicated Intrauterine devices that release contraceptive agents. Hormone-Releasing IUDs,IUD, Hormone Releasing,Intrauterine Devices, Hormone-Releasing,Intrauterine Devices, Progesterone-Releasing,Medicated Intrauterine Devices,Device, Hormone-Releasing Intrauterine,Device, Medicated Intrauterine,Device, Progesterone-Releasing Intrauterine,Devices, Hormone-Releasing Intrauterine,Devices, Medicated Intrauterine,Devices, Progesterone-Releasing Intrauterine,Hormone Releasing IUD,Hormone-Releasing IUD,Hormone-Releasing Intrauterine Device,Hormone-Releasing Intrauterine Devices,IUD, Hormone-Releasing,IUDs, Hormone-Releasing,Intrauterine Device, Hormone-Releasing,Intrauterine Device, Medicated,Intrauterine Device, Progesterone-Releasing,Intrauterine Devices, Hormone Releasing,Intrauterine Devices, Progesterone Releasing,Medicated Intrauterine Device,Progesterone-Releasing Intrauterine Device,Progesterone-Releasing Intrauterine Devices
D009644 Norgestrel A synthetic progestational agent with actions similar to those of PROGESTERONE. This racemic or (+-)-form has about half the potency of the levo form (LEVONORGESTREL). Norgestrel is used as a contraceptive, ovulation inhibitor, and for the control of menstrual disorders and endometriosis. 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17alpha)-(+-)-,DL-Norgestrel,Neogest,Ovrette,Postinor,Wy-3707,DL Norgestrel,Wy 3707,Wy3707
D010342 Patient Acceptance of Health Care Patients' willingness to receive health care. Acceptability of Health Care,Health Care Seeking Behavior,Acceptability of Healthcare,Acceptors of Health Care,Health Care Utilization,Nonacceptors of Health Care,Patient Acceptance of Healthcare,Care Acceptor, Health,Care Acceptors, Health,Care Nonacceptor, Health,Care Nonacceptors, Health,Health Care Acceptability,Health Care Acceptor,Health Care Acceptors,Health Care Nonacceptor,Health Care Nonacceptors,Healthcare Acceptabilities,Healthcare Acceptability,Healthcare Patient Acceptance,Healthcare Patient Acceptances,Utilization, Health Care
D011897 Random Allocation A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects. Randomization,Allocation, Random
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D003258 Consumer Behavior Behavior associated with the procurement of goods, services, or experiences. Consumer Preference,Consumer Satisfaction,Behavior, Consumer,Behaviors, Consumer,Consumer Behaviors,Consumer Preferences,Preference, Consumer,Preferences, Consumer,Satisfaction, Consumer
D005260 Female Females
D005387 Finland A country in northern Europe, bordering the Baltic Sea, Gulf of Bothnia, and Gulf of Finland, between Sweden and Russia. The capital is Helsinki. Aland Islands,Åland Islands
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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