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Acceptability of an experimental intracervical device: results of a study controlling for selection bias.
Contraception. 1989 Jan; 39(1):73-84.C

Abstract

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.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, University of Texas Health Science Center, San Antonio 78284.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

2491982

Citation

Shain, R N., et al. "Acceptability of an Experimental Intracervical Device: Results of a Study Controlling for Selection Bias." Contraception, vol. 39, no. 1, 1989, pp. 73-84.
Shain RN, Ratsula K, Toivonen J, et al. Acceptability of an experimental intracervical device: results of a study controlling for selection bias. Contraception. 1989;39(1):73-84.
Shain, R. N., Ratsula, K., Toivonen, J., Lähteenmäki, P., Luukkainen, T., Holden, A. E., & Rosenthal, M. (1989). Acceptability of an experimental intracervical device: results of a study controlling for selection bias. Contraception, 39(1), 73-84.
Shain RN, et al. Acceptability of an Experimental Intracervical Device: Results of a Study Controlling for Selection Bias. Contraception. 1989;39(1):73-84. PubMed PMID: 2491982.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Acceptability of an experimental intracervical device: results of a study controlling for selection bias. AU - Shain,R N, AU - Ratsula,K, AU - Toivonen,J, AU - Lähteenmäki,P, AU - Luukkainen,T, AU - Holden,A E, AU - Rosenthal,M, PY - 1989/1/1/pubmed PY - 1989/1/1/medline PY - 1989/1/1/entrez KW - Attitude KW - Behavior KW - Bias KW - Biology KW - Cervix KW - Contraception KW - Contraception Continuation--statistics KW - Contraception Termination--statistics KW - Contraceptive Agents KW - Contraceptive Agents, Female KW - Contraceptive Agents, Progestin KW - Contraceptive Methods KW - Contraceptive Usage KW - Data Adjustment KW - Data Analysis KW - Developed Countries KW - Error Sources KW - Europe KW - Evaluation KW - Evaluation Methodology KW - Family Planning KW - Finland KW - Genitalia KW - Genitalia, Female KW - Iud KW - Iud, Copper Releasing KW - Levonorgestrel KW - Measurement KW - Northern Europe KW - Physiology KW - Psychological Factors KW - Research Methodology KW - Scandinavia KW - Statistical Regression KW - Urogenital System KW - Uterus SP - 73 EP - 84 JF - Contraception JO - Contraception VL - 39 IS - 1 N2 - 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. SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/2491982/Acceptability_of_an_experimental_intracervical_device:_results_of_a_study_controlling_for_selection_bias_ L2 - https://linkinghub.elsevier.com/retrieve/pii/0010-7824(89)90016-4 DB - PRIME DP - Unbound Medicine ER -