Strategies for improving the acceptability and acceptance of the copper intra‐uterine device
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
The objective of this review is to determine the effectiveness of interventions to improve uptake and continuation of copper‐IUD.
Background
Description of the condition
Unintended or unplanned pregnancies due to contraceptive failures are associated with the method efficacy and the user adherence factors such as incorrect and inconsistent use (Kost 2008, Trussell 2004, Trussell 2009). Non‐hormonal intrauterine devices (IUDs) or copper‐IUDs are considered to be highly effective in preventing pregnancy, with failure rates being <1% and less reliance on user adherence (Trussell 2009, Mansour 2010). Copper‐IUDs are also considered effective emergency contraception (Cheng 2008).
Description of the intervention
IUDs are the most widely‐used reversible contraceptive method in the world (at 14.2% in 2009 and 15.4% in 2007), followed by pill and male condoms (United Nations 2008, United Nations 2009). An estimated 175 million women worldwide were using copper‐IUDs and Intrauterine Systems (IUS) in 2007, of whom 5 million used hormonal IUS (Sivin 2010). This high prevalence is attributed to the copper‐IUD being the most commonly used method in developing countries, particularly China (United Nations 2008, United Nations 2009).
Contraceptive choices and use, or non‐use, of particular methods are influenced by a number of complex factors. These include socio‐demographic, knowledge, information, lifestyle need, perceptions of women, availability and accessibility of services, health care providers attitude and knowledge; and also other external factors such as legal restrictions on the availability of abortion services and reproductive rights (Belfield 2009, Campbell 2006, Frost 2008, Oddens 1997, Wellings 2007).
How the intervention might work
Interventions could be client or provider focused and may include provision of educational materials or programme, peer or multi‐component counselling, medical interventions to increase acceptability, provider education programmes and checklist tools. The quality of family planning counselling is an important component in increasing contraceptive uptake; interventions such as specialist contraceptive counselling can increase uptake of long‐term contraceptive methods (Schunmann 2006, Davie 1996).
Why it is important to do this review
Although IUDs are the most commonly used reversible contraceptives in the word, the use of IUDs is much lower (at 9%) in developed countries, where the most commonly used methods are pills and condoms. Furthermore, national surveys of contraceptive use in the United Kingdom show that the use of Long‐Acting Reversible Contraceptives (LARCs) including copper‐IUDs is lower than many other European countries (Lader 2009). A large study of contraceptive use among 12,000 women (age between 15 to 49 years old) across five European countries also shows that pills and condoms are the most commonly used methods in Europe, with the United Kingdom showing the lowest use of IUDs (Skouby 2004, Haimovich 2009).
Interventions or strategies to improve acceptance and acceptability of hormonal contraceptives were assessed in a previous Cochrane systematic review (Halpern 2006). This systematic review will examine whether client‐ and provider‐interventions could increase uptake or continuation of a non‐hormonal long acting reversible method, namely copper‐IUDs.
Objectives
The objective of this review is to determine the effectiveness of interventions to improve uptake and continuation of copper‐IUD.
Methods
Criteria for considering studies for this review
Types of studies
Eligible studies are randomised controlled trials and controlled clinical trials, controlled before‐and‐after studies comparing an intervention with usual practice or comparing multiple interventions, and interrupted time series that reported objectively measured outcomes concerning the effect of interventions to improve uptake of contraception including copper‐IUD.
Types of participants
Eligible participants will be women of reproductive age.
Types of interventions
Promotion of copper‐IUD need not be the primary aim of the intervention. Interventions could include: intensive counselling techniques; decision‐aids; information provision in various formats; group or individual counselling; education and training programmes for the providers.
Types of outcome measures
Primary outcomes
The primary outcome is uptake, use or prevalence of copper‐IUD post‐intervention.
Secondary outcomes
We will measure continuation of copper‐IUD as a secondary outcome, as not all studies may include discontinuation or removal rate. Other secondary outcomes are: knowledge of contraception (copper‐IUD), reasons for use or non‐use of contraceptive (copper‐IUD) and reasons for removal if available.
Search methods for identification of studies
We will conduct searches of the databases listed using the search terms described, and remove duplicates.
Electronic searches
We will search computerised databases, Cochrane Central Register of Controlled Trials (CENTRAL), Pubmed, MEDLINE, EMBASE, POPLINE, PsycINFO, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), OpenSIGLE (System for Information on Grey Literature in Europe) using the following key words: contracepti*, birth control, uptake, use, acceptance. The search strategies are for each computerised databases are listed below.
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CENTRAL search will use search terms contracepti* OR birth?control AND (compliance OR accept* OR adherence OR continu* OR discontinu* OR use OR uptake)); search restricted to Cochrane Reviews, Other Reviews, Clinical Trials, and date range limited to 1990‐2010.
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PubMed search will use search terms (contracepti* OR "birth control") AND (intervention AND (compliance OR acceptance OR adherence OR continu* OR discontinu* OR use OR uptake)).
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POPLINE search will use search terms (contracepti* / birth control) & (intervention & (accept* / adherence / continu* / discontinu* / use / uptake).
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EMBASE, PsycINFO, MEDLINE (via OVID)searches will use search term, (contracepti* OR birth control) AND (intervention AND (compliance OR accept* OR adherence OR continu*)); search limited to humans, publication year 1990‐2010.
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ClinicalTrials.gov search will use search terms contraceptive OR contraception OR birth control OR family planning; search limited by gender, not seniors 66+.
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WHO International Clinical Trials Registry Platform (ICTRP) search will use search terms contraception OR contraceptive OR in the Condition search field.
We will use general term contraception or contraceptive to ensure that the interventions with primary or secondary outcome of contraceptive use or uptake of the participants including copper‐IUD are not missed during the search. We will also include the term ‘birth control’ and ‘family planning’ for clinical trials as some studies may be listed under these keywords.
Searching other resources
In addition to computerised database search, we will also handsearch studies listed in the previous systematic reviews and studies listed in the references of included studies. We will attempt to contact the first authors of identified and included studies to request additional information about the study, as well as information about published or unpublished trials not discovered in our search.
Data collection and analysis
The two review authors (MA and CA) will independently screen the titles and abstracts of all articles and reports found using the above search strategy to identify relevant studies. The full text of all the relevant studies will be retrieved and screened independently, according to our inclusion and exclusion criteria. We will disregard those that do not meet our inclusion criteria or those that clearly meet our exclusion criteria, and the reasons for this removal will be recorded.
We will also retrieve relevant studies listed in the reference list of included studies or those within the reviews included. Selection criteria will be applied and the two independent reviewers will compare their final list of included studies, resolving any discrepancies through discussion with the supervisor who is also the third author (SS).
Selection of studies
We will screen all articles, reports titles and abstract published in English and, wherever possible, seek translations of relevant studies published in other languages to be included. We will include all studies published between January 1990 and April 2010. Studies which focused on women with chronic health conditions such as HIV will be excluded. We will also exclude studies that do not present any of the outcome measures.
Data extraction and management
We will develop a data abstraction template; the primary and secondary reviewers will then independently extract data from the studies included in the review. We will contact the researchers to obtain additional information about the study when necessary. The data will be entered and analysed using Review Manager 5.
Assessment of risk of bias in included studies
We will assess the biases, and risk of biases, of included studies using a domain‐based evaluation as recommended by the Cochrane Handbook (Higgins 2009). We will consider factors such as study design, randomisation method, allocation concealment, blinding, and losses to follow‐up.
Measures of treatment effect
The primary outcome of uptake will be measured by number of women using or used copper‐IUDs during and post intervention. The continuation of copper‐IUDs will be measured by the number of women who discontinued use or removed the method. We will also calculate the number need to treat (NNT) for each intervention identified.
Unit of analysis issues
We will follow the method of combining groups as recommended in the Cochrane Handbook in cases of cluster‐randomized trials and cross‐over trials.
Dealing with missing data
The original investigators of the study will be contacted to request for the missing data and results including standard deviations or results shown in figures without specific numbers for analysis. Where missing data is not available, we will consider exclusion of the study and run a sensitivity analysis to assess the impact of exclusion. If any assumptions were made on the missing data, such as missing at random or assumed to have a particular value, we will include potential impact of missing data in the Discussion section of the review (Higgins 2009).
Assessment of heterogeneity
We will assess the outcome data for heterogeneity using I2 statistic. We will not pool the results if the heterogeneity is significant. Subgroup analyses will be performed to explore possible causes of heterogeneity in the first instant. We will consider exclusion of outlying studies if appropriate, and analyses of both with and without outlying studies will be performed as part of the sensitivity analysis.
Assessment of reporting biases
We will use funnel plots to identify possible biases. Selective outcome reporting is common and we will assess all reporting biases at the study‐level as recommended in Cochrane handbook (Chan 2005, Kirkham 2010). The assessment results of reporting biases will be included within the summary table.
Data synthesis
Data will be analysed with Review Manager 5 using odds ratio (OR) for all dichotomous outcomes and the mean difference (MD) for continuous data, with 95% confidence intervals for all outcomes. We will conduct separate meta‐analyses grouped on the basis of intervention types and participant characteristics.
Subgroup analysis and investigation of heterogeneity
We will carry out statistical heterogeneity as well as subgroup analysis. We will conduct subgroup analyses by intervention type, participant characteristics or any other relevant subgroups presented by the studies.
Sensitivity analysis
We will use sensitivity analyses to investigate whether the treatment effect size will vary by studies excluded due to design or methods.
