Strategies to improve compliance and acceptability of hormonal methods for contraception
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
The review will test the hypothesis that ancillary techniques, including but not limited to structured counseling, peer counseling and intensive reminders of follow‐up appointments, improve compliance and continuation rates of hormonal methods of contraception as compared to routine family planning counseling.
Background
Hormonal methods of contraception, including combined oral contraceptives (COCs), levonorgestrel implants and injectables, represent widely used methods of birth control. Approximately 18 million women use birth control pills in the U.S. ( Rosenberg 1995); an estimated 3.5 million women use the progestin‐only injectable Depo‐Provera worldwide (Mishell 1991). The popularity of these methods is due to their effectiveness, safety, reversibility, and wide range of non‐contraceptive health benefits.
However, in spite of good initial acceptance, hormonal contraceptives are characterized by either poor compliance or by relatively high discontinuation rates. About half of COC users miss one or more pills each month, and 25% miss two or more (Rosenberg 1998). Difficulties in correct pill intake lead to discontinuation and, in many cases, subsequent unintended pregnancy. An estimated 32% of new COC users discontinue the method in the first year of use (Schwartz 2002). Together, unintended pregnancies following pill discontinuation and poor compliance are estimated to account for 20% of the 3.5 million annual unintended pregnancies in the U.S. (Rosenberg 1999). The continuation rates for Norplant are from 87% to 90% at one year and 72% at two years (Fleming 1998; Glasier 2002). The existing data on discontinuation rates for Depo‐Provera vary greatly with some studies reporting discontinuation rates as high as 70% at six months (Lim 1999).
The declining level of acceptance is caused primarily by complicated regimens of intake of the pills among COC users and by the induced side effects among implant and injectable users (Davie 1996; Lei 1996). The search for an "ideal" contraceptive characterized by minimal side effects, excellent tolerability and high continuation rates led to the recent introduction of ultra‐low‐dose combined pills and combined injectables, as well as new contraceptive delivery systems (e.g., skin patch, hormone‐releasing intrauterine system and intravaginal ring). However, the new methods have not been associated with substantial improvement in contraceptive continuation or compliance: continuation rate for combined injectable "Cyclofem" at the end of the first year is as high as 52% (Hall 1997); 15% of NuvaRing users are not compliant with the dosing regimen (Dieben 2002); and during the first year of use at least 25% of women discontinue the levonorgestrel intrauterine system, which has been described as close to an "ideal contraceptive" (Diaz 2000).
While rationality of further search for an "ideal" contraceptive requires thorough consideration, alternative approaches to improve contraceptive practices should be explored. Contraceptive continuation is thought to be linked strongly with the quality of family planning service; a recent study demonstrated that within the first year of starting a method, seven to 27 percent of women cease to practice contraception because of factors related to the quality of service (Blanc 2002). According to Jain et al. (Jain 1989), client‐provider relations and information provided to the users represent the important elements of the quality of family planning service that could affect contraceptive compliance and acceptability. However, positive association between counseling (or other ways of the information exchange between the client and provider) and contraceptive continuation is scantily documented. The proposed review will look into the hypothesis that advanced counseling techniques or other client‐provider interventions can increase the effectiveness and continuity of contraceptive practices.
Objectives
The review will test the hypothesis that ancillary techniques, including but not limited to structured counseling, peer counseling and intensive reminders of follow‐up appointments, improve compliance and continuation rates of hormonal methods of contraception as compared to routine family planning counseling.
Methods
Criteria for considering studies for this review
Types of studies
Eligible studies are randomized controlled studies comparing one or more intensive counseling techniques or other provider interventions with routine family planning counseling.
Types of participants
Eligible participants are women of reproductive age without medical contraindications to hormonal methods of contraception.
Types of interventions
Eligible interventions are provider‐client interventions including but not limited to structured counseling, peer counseling and intensive reminders of follow‐up appointments, designed to facilitate the use of hormonal methods of contraception.
Types of outcome measures
Anticipated outcome measures include but not limited to discontinuation rate; reason for discontinuation; number of missed pills; number of on‐time injections; pregnancy rate.
Search methods for identification of studies
We will search the computerized databases the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE using PubMed, POPLINE, EMBASE, Pascal, PsycINFO, Dissertation Abstracts Online, Africa Index Medicus, INEMR and IMSEAR for randomized controlled trials comparing client‐provider interventions versus standard family planning counseling.
Our CENTRAL search will use the strategy:
(counseling OR compliance OR acceptability OR continuation OR discontinuation) AND hormonal contraceptives
We will search MEDLINE via PubMed with the recommended Cochrane search strategy revised for PubMed searches (Robinson 2002): ((randomized controlled trials [pt] OR controlled clinical trial [pt] OR randomized controlled trials [mh] OR random allocation [mh] OR double‐blind method [mh] OR single‐blind method [mh] OR clinical trial [pt] OR clinical trials [mh] OR ("clinical trial" [tw]) OR ((singl* [tw] OR doubl* [tw] OR trebl* [tw] OR tripl* [tw]) AND (mask* [tw] OR blind* [tw])) OR ("latin square" [tw]) OR placebos [mh] OR placebo* [tw] OR random* [tw] OR research design [mh:noexp] OR comparative study [mh] OR evaluation studies [mh] OR follow‐up studies [mh] OR prospective studies [mh] OR control* [tw] OR prospective* [tw] OR volunteer* [tw]) NOT (animal [mh] NOT human [mh])) AND ((counseling [tw]) OR (intensive reminders [tw]) OR (peer counseling [tw]) OR (structured counseling [tw])) AND ((compliance [tw]) OR (discontinuation [tw]) OR (continuation [tw]) OR (acceptability [tw]) OR (adherence [tw]) OR (patient acceptance of health care [tw])) AND (Depot medroxyprogesterone acetate [tw]) OR (medroxyprogesterone 17 acetate [mh]) OR (contraceptive agents, female [tw]) OR (contraceptives, oral [mh]) OR (contraceptives [tw]) OR (Norplant [tw]) OR (implants [tw]) OR (contraceptives, injectable [tw]) OR (NET‐EN [tw]) OR (Mesigyna [tw]) OR (Cyclofem [tw]) OR (vaginal ring [tw]) OR (levonorgestrel‐releasing intrauterine system [tw]) OR (Mirena [tw]) OR (contraceptive devices, female [tw]) OR (transdermal contracpetive patch [tw]) OR (contracpetive patch [tw])
Our POPLINE search will use the strategy:
Counseling AND (compliance OR user compliance OR adherence OR acceptability OR discontinuation OR continuation) AND (oral contraceptives OR Depot medroxyprogesterone acetate OR Norplant OR contraceptive implants OR contraceptive injectables OR vaginal ring OR vaginal rings OR NET‐EN OR Mesigyna OR Cyclofem OR levonorgestrel‐releasing intrauterine system OR transdermal contracpetive patch OR contraceptive patch OR patch) AND (compar* OR clinical trials OR comparative studies OR random OR double‐blind studies)
Our EMBASE search will use the strategy:
Counseling AND (compliance OR user compliance OR acceptability OR acceptors OR acceptance OR discontinuation OR continuation OR adherence) AND (Norplant OR implant OR implants OR drug implant OR oral contraceptive agent OR medroxyprogesterone acetate OR injecatble OR injectables OR drug injection OR vagianl ring OR contraceptive patch OR (levonorgestrel AND (IUD OR IUS OR intrauterine device OR intrauterine system))
Africa Index Medicus, INEMR and IMSEAR search will use the strategy for MEDLINE
Pascal, PsychInfo, Dissertation Abstracts Online will use the strategy for EMBASE
Data collection and analysis
The primary reviewer will evaluate all titles and abstracts located in the literature searches to determine whether they met the inclusion criteria. The methodological quality of the trials will be assessed using the Cochrane guidelines. We will write to the first authors of all identified and included studies to request information about published or unpublished trials not discovered in our search, as well as additional information about the methods of the study and the various outcome measures. Both the primary and a second reviewer independently will extract data from the studies identified for inclusion. Data will be entered and analyzed with RevMan 4.1. We will calculate Peto odds ratios with 95% confidence intervals for all outcomes. Clinical heterogeneity will be assessed by reviewing characteristics of participants in the identified trials. Statistical heterogeneity will be evaluated by using the chi‐squared test.
