PROTOCOL: Interventions to reduce the prevalence of female genital mutilation/cutting in African countries

Female genital mutilation/cutting (FGM/C) is a traditional practice that involves the partial or total removal or other injury to the female genital organs for cultural or other non-therapeutic reasons (WHO, 2008). The current classification describes four types of FGM/C: Type 1, clitoridectomy involves partial or total removal of the clitoris and/or the prepuce. Type 2, excision, involves partial or total removal of the clitoris and the labia minora, with or without excision of the labia majora. Type 3, infibulation, involves narrowing of the vaginal orifice with creation of a covering seal by cutting and appositioning the labia minora and/or the labia majora, with or without excision of the clitoris. Infibulation is considered the most invasive type of FGM/C. Defibulation, opening of the covering seal, is often necessary prior to childbirth. Reinfibulation refers to the recreation of an infibulation after defibulation. Type 4, other, involves all other harmful procedures to the female genitalia for non-medical purposes, for example: pricking, piercing, incising, scraping and cauterizing (WHO, 1997). FGM/C is practised in more than 28 countries in Africa, usually on girls under the age of 15 years, and in some countries in the Middle East and Asia. FGM/C is also practised by immigrant communities in a number of other countries, including Australia, Canada, France, New Zealand, Norway, Sweden, Switzerland, the United Kingdom, and the United States (HRP, 2006). Recent figures for African countries show a prevalence of FGM/C of more than 70 percent in Burkina Faso, Djibouti, Egypt, Eritrea, Ethiopia, Guinea, Mali, Mauritania, Northern Sudan, and Somalia (Yoder & Kahn, 2008). However, there is great variation in prevalence between and within countries, reflecting ethnicity and tradition. Therefore, UNICEF (2005) has proposed that countries be categorized in three groups according to FGM/C prevalence rates: Group 1, 80 percent or higher prevalence, e.g. Ethiopia and Somalia, Group 2, 25-79 percent, e.g. Senegal and Kenya, and Group 3, 1-24 percent, e.g. Nigeria (Table 1). The practice of FGM/C is rooted in religious, personal and societal beliefs within a frame of psycho-sexual and social reasons such as control of women's sexuality and family honour, which is enforced by community mechanisms (WHO, 1999). While reasons for the practice vary across cultural groups, social reasons may include FGM/C as an initiation act for girls into womanhood, as an act of social integration and for the maintenance of social cohesion. Socio-economic reasons include beliefs that FGM/C is a prerequisite for marriage or an economic necessity in cases where women are largely dependent on men. Religious reasons rest on the belief that it is a religious requirement. Hygienic and aesthetic reasons for FGM/C include beliefs that the female genitalia are dirty and unsightly, and health reasons include beliefs that FGM/C enhances fertility and child survival. FGM/C may also be an important source of income for circumcisers (UNFPA, 2007). Girls exposed to FGM/C are at risk of immediate physical consequences, such as severe pain, bleeding, and shock, difficulty in passing urine and faeces, and infections. Long term consequences can include chronic pain and infections (WHO, 2008). In general, the consequences are similar for FGM/C Type I, II, and III, but they tend to be more severe and more prevalent the more extensive the procedure (WHO, 2008). A systematic review of the health complications of FGM/C (WHO, 2000) identified a range of obstetrical problems, the most common being prolonged labour and/or obstruction, episiotomies and perineal tears, post partum haemorrhage, and maternal and foetal death. A recent study investigating 28,393 women attending 28 obstetric centres in several African countries (Banks et al, 2006) concluded that women with FGM/C are significantly more likely than those without to have adverse obstetric outcomes such as a caesarean, postpartum blood loss 500 mL, extended materna I hospital stay, birth weight <2500 g, infant resuscitation, and inpatient perinatal death. The authors also concluded that the risks seemed to be greater with more extensive FGM/C. For many girls and women, undergoing FGM/C is a traumatic experience that leaves a lasting psychological mark and may adversely affect their mental health. In fact, several psychological and psychosomatic disorders such as disordered eating and sleeping habits have been attributed to FGM/C (HRP, 2006). There are also reports of posttraumatic stress disorder, anxiety, and depression associated with FGM/C (WHO, 2008). FGM/C is a deeply entrenched social convention among some ethnic groups and as such carries consequences both when it is and when it is not practised. When girls and families conform to the practice they acquire social status and respect. For girls, undergoing FGM/C promotes honour and her full acceptance in the community, as well as imparts a sense of pride and of coming of age (UNICEF, 2005). In some societies, the link between FGM/C and value is explicit: girls who undergo FGM/C often receive rewards in the form of celebrations and gifts, and the bride price for a girl who has been cut is much higher than that for one who has not (Wheeler, 2003). For families, fulfilling the cultural expectation that girls should be cut assigns status and community membership. Conversely, failure to conform leads to difficulty in finding a husband for the girl, shame, stigmatization, as well as loss of social status, honour and protection, resulting in the family's social exclusion in the community (UNICEF, 2005). Sexual consequences of FGM/C were summarized in a non-systematic literature review (Obermayer, 2005), which concluded that the available evidence does not support the notion that FGM/C automatically precludes sexual activity or the enjoyment of sexual relations. The results from a recent systematic review by the authors of the present project proposal suggest that women with FGM/C experience pain and reduction in sexual satisfaction and desire compared to women without FGM/C. The evidence base is however insufficient to draw causal conclusions about the consequences of FGM/C (Berg et al, 2010a). Efforts to abandon the practice of FGM/C in Africa have used several different approaches which, in turn, have had implication for interventions. These approaches include those based on human rights frameworks, legal mechanisms, health risks, alternative rites, positive deviance, training health workers as change agents, training and converting circumcisers, and the use of comprehensive social development processes. Interventions based on these approaches have targeted stakeholders at individual, interpersonal, community and national levels (Muteshi & Sass, 2005). In 2007, the Population Reference Bureau (PRB) published their results of an extensive survey of current intervention projects taking place in African countries (Feldman-Jacobs & Ryniak, 2007). In total, PRB identified 92 projects, 27 of which were evaluated, mostly by observational designs. Only four of the 27 evaluated projects (15%) used a controlled before-and-after design, and about a dozen of the evaluations used cross-sectional or pre-post intervention questionnaires or interviews without a comparison group. While contributing great understanding about the range of interventions initiated to curb the prevalence of FGM/C, the overview did not reach any conclusions about the effectiveness of interventions. More recently, the authors of the proposed project specifically examined the effectiveness of interventions to reduce the prevalence of FGM/C in a systematic review (Denison et al, 2009). Through our literature search of February 2009 we identified a total of seven controlled studies, six of which could be obtained in full text. All six studies were controlled before-and-after studies carried out in African countries. In contrast to the PRB overview (Feldman-Jacobs & Ryniak, 2007), we included only controlled studies, i.e. studies with reference to a non-intervention comparison group, and we concluded that while the evidence base is insufficient to draw definite conclusions, there are possible advantageous developments as a result of interventions. Notably, the review highlighted the uncertainties regarding relevance of the interventions (e.g. regarding objectives, intervention targets, activities). That is, since it was not a focus of the systematic review, we were unable to provide any assessment of the degree to which the interventions were appropriate responses to the populations' needs with respect to FGM/C, including the degree to which factors that contribute to the perpetuation of the practice were taken into account in the interventions. It is apparent that the degree of relevance of the intervention exerts a considerable influence on an intervention's effectiveness in reaching its designated goals, and may to a large extent help explain variation in behavioral and other outcomes among members of groups. In sum, two recent publications have examined aspects of interventions designed to reduce the prevalence of FGM/C. However, the effectiveness of interventions in the context of relevance has yet to be explored. FGM/C is a long-standing tradition that has become inseparable from ethnic and social identity among many groups (UNICEF, 2005). Disaggregation of data from the Demographic and Health Surveys (DHS)2 shows that the practice of FGM/C varies by demographic variables such as age, urban-rural residence, and region or province, and also by variables such as education, ethnicity and religion (Yoder et al, 2004). Further analysis of DHS data by UNICEF suggests that educational attainment, a woman's own circumcision status and ethnicity have the greatest influence in explaining support or opposition to the practice (UNICEF, 2005). Thus, programmes designed to reduce the prevalence of FGM/C should be country specific and adapted to reflect regional, ethnic and socio-economic variances while also taking into account the diverse reasons why FGM/C is practised among a given ethnic or cultural group (UNICEF, 2005). The review will summarize data relating to 1) key intervention program features, targeted participants, main outcomes, and estimates of intervention effectiveness and 2) factors related to the continuance and discontinuance of FGM/C, such as demographic factors, the frequency and strength of various stakeholders' cognitions and behaviours related to FGM/C, and stakeholders' lived understanding of the persistence of the practice. This will allow us to analyse not only effectiveness of interventions but also their relevance, i.e. the extent to which intervention programs have heeded and built upon factors related to the continuance and discontinuance of FGM/C, the extent to which interventions have been provided to the most appropriate stakeholder groups, and which forces have been overlooked as critical program elements. Overall, we will conduct the review according to the guidelines in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins & Green, 2009) and guidelines for systematic reviews in the social sciences (Petticrew & Roberts, 2006). Answering research question 2 will involve synthesizing quantitative and qualitative evidence and we will follow guidance by Pope et al (2007). Briefly, we will proceed with the review in the following manner: search for empirical studies, screen studies, extract data, summarize data, perform analyses, and write up results. Selection of primary studies will be based on the inclusion criteria described above. The Reference Manager database containing the search results will be used to keep track of references identified through the electronic database search (to be screened for inclusion). Screening of literature will proceed at two levels. For level 1 screening, two reviewers (RB and ED) will independently perform an assessment of the identified records by reading the title, and when available, abstract. The pre-developed inclusion questions for level 1 are based on the inclusion criteria described in 3.1.1 and 3.1.2. They are listed in Appendix 1. The reviewers answer each question "Yes" (= promote), or "Can't tell" (= promote), or "No" (=exclude, do not promote). The reviewers then compare and discuss their judgments. Differences in opinion at level 1 screening will be resolved by promoting the record to level 2 screening. Records that unmistakably fail to meet the inclusion criteria will be excluded, such as editorials and commentaries. Records not excluded at level 1 are promoted to level 2 screening, and ordered in full text. At level 2 screening, two reviewers (RB and ED) will independently evaluate the full text of each record promoted from level 1 screening for inclusion, in accordance with Cochrane guidelines. They will use a pre-developed inclusion form (Appendix 1) based on the inclusion criteria described in 3.1.1 and 3.1.2. There will be a separate set of screening questions for records describing the effect of interventions and records reporting on reasons for the perpetuation of FGM/C (Appendix 1)). The reviewers answer each question "Yes" (= Include), "No" (= Exclude) or "Can't tell" (=Discuss). The reviewers then compare and discuss their assessments. Differences in assessment at level 2 screening will be discussed until consensus is reached. If consensus can't be reached, a third review member (SL or JOJ) will be asked to resolve disagreements. The reference is included when the reviewers agree to score "Yes" to all questions. The reference is excluded when the reviewers agree to score "No" to any one question. If the reviewers score "Can't tell" to any one question, the inclusion question will be resolved by re-reading of the text, discussion and consensus (or resolved by a third person if consensus can't be reached). The main reason for exclusion at this stage will be recorded for each record, and a list of excluded records (with reasons) will be created. These steps are in accordance with the Cochrane Handbook (Higgins & Green, 2009) In the interest of time, the reviewers will not at any screening level be blinded to the authors or other information about the record when assessing the studies. When there is more than one record of the same study, we will include all records meeting the inclusion criteria, but use the most relevant one, i.e. the publication containing the most complete data set, as the main record. Once included, we will group all included studies according to their methodological focus into three main study types: 1) effectiveness studies, 2) quantitative views studies, 3) qualitative views studies. The primary method of study identification will be electronic searches, as advised by the Cochrane Handbook (Higgins & Green, 2009)). For the recently completed systematic review of the effectiveness of interventions designed to prevent the prevalence of FGM/C we searched systematically for relevant literature up to February 2009 in 13 international databases: African Index Medicus, Anthropology Plus, British Nursing Index and Archive, The Cochrane Library (CENTRAL, Cochrane Database of systematic Reviews, Database of Abstracts of Reviews of Effects), EMBASE, EPOC, MEDLINE, PILOTS, POPLINE, PsychINFO, Social Services Abstracts, Sociological Abstracts, and WHOLIS. Under the guidance of one reviewer (ED) a research librarian performed the searches using a strategy incorporating subject headings (for example MeSH terms in MEDLINE, see http://www.nlm.nih.gov/mesh/) and text words (in title and abstract) relating to FGM/C and the four classifications thereof. No method filters were applied as we were more concerned about sensitivity than specificity and prepared to screen a large number of references. We did not restrict our searches by country or language. The MEDLINE search strategy served as the model for the other database searches using appropriate controlled vocabulary as applicable. Our search strategy for MEDLINE is shown: We will include databases for 'grey' literature (defined here as "reports that are produced by all levels of government, academics, business and industry in print and electronic formats but that are not controlled by commercial publishers" [Higgins & Green 2009]): Demographic and Health Surveys, British Library for Development Studies, IDEAS, JOLIS, Google Scholar, and Google. Theses and dissertations will be included. In addition to the electronic database search, we will perform bibliographic back-referencing to identify new leads. We will also supplement the electronic search with searches in databases of six international organizations that are engaged in projects regarding FGM/C: Centre for Development and Population Activities (CEDPA), Population Council, Population Reference Bureau (PRB), The United Nations Children's Fund (UNICEF), The United Nations Population Fund, and The World Health Organization (WHO). Notably, Popline contains ministerial reports on FGM/C. We will also ask for suggestions for literature we may have missed from FGM/C experts, e. g. the research director of Population Council. Forward citation tracking will be performed through the ISI Web of Knowledge in order to identify further studies. Lastly, we will conduct a hand search of relevant journals (African Journal of Reproductive Health, Social Science & Medicine). Two authors (RB and ED) will independently extract data from the published sources using a pre-designed data extraction form, as recommended in the Cochrane Handbook. Data to be extracted from studies included for answering Research question 1: publication identification details (author, year, and source), study design, study setting, population, intervention details, comparisons, outcomes, follow-up details, attrition and missing data details, outcome data (for dichotomous data: number of events, number of persons in the groups, and p-values; for continuous data: means, standard deviations, and p-values), and effect estimates. Intervention details will be classified according to a taxonomy of behaviour change techniques used in interventions proposed by Abraham and Michie (2008). The data extraction form for RQ 1 appears in Appendix 4. Data to be extracted from studies included for answering Research question 2: publication identification details (author, year, and source), study design, study setting, population, quantitative or qualitative data related to the continuance and discontinuance of FGM/C, i.e. demographic factors, the frequency and strength of various stakeholders' cognitions and behaviours related to FGM/C, and stakeholders' lived understanding of the practice. With respect to qualitative-based studies, the reviewers will read the texts independently of each other and extract all text data related to views about FGM/C in of stakeholders' for its continuance and Our extraction of data will be et al 2007). We will all in the form of or text to with reasons for continuance and discontinuance our pre-designed data extraction The data extraction form for RQ 2 appears in Appendix extraction of data, the two reviewers will compare their and resolve any by discussion and the text. Two authors (RB and ED) will independently the of studies, using appropriate for included study they will compare and discuss their assessments. If consensus can't be reached, a third person will be asked to resolve disagreements. included for answering Research question 1 will be by The Health for (Appendix The Cochrane Handbook this for reviews in the health (Higgins & Green, Reviews in health and health The the following study design, data and intervention and A are each given a of or according to a of or is according to the following with than four and one or more A of or methodological will be upon by the reviewers after there was a with respect to the and will be in studies included for answering Research question 2 will be according to guidelines for prevalence studies The guidelines and analysis which have been into a seven criteria by at The Knowledge Centre for the Health Services (Appendix A of or study is given according to the all criteria are change the of the criteria are not or not may change criteria are or the may be criteria The reviewers will agree on a of or methodological (or after there was a with respect to the seven studies included for answering Research question 2 will be by a designed by the 2006). 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With respect to analyses, we will present dichotomous data for the outcomes listed in the inclusion criteria in results when and post for both intervention and comparison groups are by study We will of interventions in two we effect by the risk in which the pre-post change score (in in the comparison group will be from the pre-post change score (in in the intervention group. is to be large is a we also into we will effect by the risk and percent based on The of using this is that effect can be at be to of the effect studies we have identified is we will to use this studies be identified in the search and included in the review we will these is that some of of will be present when conclusions are from the results. We will present continuous data with and of effect for each of outcomes will be or will be used to sources of If of studies are identified of studies with one dichotomous will be used to perform variables are intervention and of (e.g. educational training health workers as change agents, comprehensive social stakeholder and The of quantitative and qualitative data describing factors will to the understanding of results from the intervention studies, and to help interventions more in to their question We will an evidence quantitative evidence has methodological Data extraction and of quantitative and qualitative evidence will largely be completed in separate 1, Appendix Data from cross-sectional survey studies will be with data from studies which examined various stakeholders' of factors the continuance and discontinuance of FGM/C Our evidence is largely based on published and guidelines from the for and and Centre et et & 2008). The will be et 2006) and focus on data by similar data from the quantitative studies and the qualitative studies. we will the two of evidence is from the quantitative data set will be used as for the qualitative data the analysis we will place most weight on the quantitative such that the qualitative results are under the quantitative results and the qualitative results the results from the quantitative With respect to the quantitative studies 2, 1, Appendix we will use a 2009) to the extracted quantitative data across studies. for each study and each group of we will review the extracted and according to our such as reasons for FGM/C. We will then the of these in order to a list of factors, up with one list for each stakeholder group in each Thus, we will be to both data across studies and With respect to the qualitative evidence 3, 1, Appendix our analysis is and on published studies et et 2006). analysis involves or in the literature and the of the different studies under headings 2005). 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