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The effects of asking a fertility intention question in primary care settings: a systematic review protocol Henning, Paul A; Burgess, Carolyne K; Jones, Heidi E; Norman, Wendy V Jan 19, 2017

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PROTOCOL Open AccessThe effects of asking a fertility intentionquestion in primary care settings: asystematic review protocolPaul A. Henning1,2*, Carolyne K. Burgess3, Heidi E. Jones3 and Wendy V. Norman2AbstractBackground: Planning for pregnancy has been associated with reduced unwanted pregnancies and improvedpregnancy outcomes. Despite the benefits of planned pregnancy, there are no guideline recommendations onroutine counseling regarding pregnancy intention in primary care settings. The objective of the systematicreview is to determine the effectiveness of incorporating questions of pregnancy intention into primary care.Methods: A systematic search of the literature will be conducted for any studies comparing questions of pregnancyintention in primary care settings with no intervention or a control intervention. Types of studies will include randomizedcontrolled trials, non-randomized trials, and observation studies. Participants will include patients of reproductive agepresenting to primary health care settings. Interventions will include any assessment of fertility intention and follow-upcare compared with a control group or no intervention. Outcomes will include quantitative data with rates forcontraceptive uptake, and any pregnancy related outcome. Databases (Ovid MEDLINE; Pubmed; CINAHL; EMBASE; CDR/DARE databases; Web of Science; ISRCTN registry; Clinicaltrials.gov; Cochrane Library) will be searched from the year 2000to current. Screening of identified articles and data extraction will be conducted in duplicate by two independentreviewers. Methodological quality will be assessed using the Jadad scale. Methodological quality of observational andnon-randomized trials will be assessed using the Newcastle-Ottawa scale. Discrepancies will be resolved by consensus orby consulting a third author. Meta-analyses will be performed if appropriate.Discussion: Determining the effect of including questions of pregnancy intention into primary care can provide evidencefor the development of clinical practice guidelines and inform primary care providers if this simple and low-costintervention should be routinely employed. This review will also identify any gaps in the current literature on this topicand provide direction for future research in this area of study.Systematic Review Registration: PROSPERO CRD42015019726Keywords: Planned pregnancy, Contraception, Family planning, Pregnancy outcomes, Unplanned pregnancy, Pregnancycomplications, Preconception care, Prenatal careBackgroundSexual and reproductive healthcare are importantcomponents of overall health and should be addressedon a regular basis in the context of ongoing medicalcare. Taking steps to achieve one’s own fertility inten-tions is a vital part of reproductive health and isassociated with improved pregnancy outcomes. In con-trast, unintended pregnancies can have serious health,economic, and social consequences for women and theirfamilies [1]. In the United States half of pregnancies(51%) are unintended and 42% of this end in abortion [2, 3].Similarly high rates of unintended pregnancy are found indeveloping countries with up to 64% of pregnancies beingunintended in South America [4]. Unintended pregnancyhas been identified as a human rights concern. At the 1994International Conference on Population and Development(ICPD) held in Cairo, the Programme of Action stated that“[a]ll couples and individuals have the basic right to decide* Correspondence: paul.henning@ahs.ca1Department of Obstetrics and Gynaecology, University of Calgary, Calgary,Canada2School of Population and Public Health, |University of British Columbia,Vancouver, CanadaFull list of author information is available at the end of the article© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.Henning et al. Systematic Reviews  (2017) 6:11 DOI 10.1186/s13643-017-0412-zfreely and responsibly the number and spacing of their chil-dren and to have the information, education and means todo so” [5].A variety of improved outcomes have been associatedwith planned pregnancy. Planned pregnancy has beenassociated with reduced maternal risk behaviors, increasedantenatal care, improved birth outcomes, decreased infantand child mortality, increased breastfeeding, decreasedmaternal mortality, and decreased unsafe abortion [6].Studies have also linked wanted pregnancy to reducedlong-term social and health impacts on older children,adolescents, and adults [7, 8].Despite the benefits of planned pregnancy, there areno guideline recommendations on the provision ofroutine counselling regarding pregnancy intention inprimary care settings. In 1995, the U.S. PreventiveServices Task Force (USPSTF) included counseling as arecommended intervention to prevent unintended preg-nancy. However, this recommendation was absent fromsubsequent published recommendations [9].The objectives are to (1) systematically identify andassess studies on the effectiveness of routinely asking in-dividuals of reproductive-age in primary care settingsabout their fertility plans; (2) synthesize evidence onincorporating a question on pregnancy intention intoprimary care; (3) provide evidence to primary care orga-nizations to inform the development of practice guide-lines; and (4) provide a framework for interventionstrategies to support individuals to realize their fertilityintentions.Methods and designThe review protocol was registered with the PROSPEROInternational Prospective Register of Systematic Reviews(Registration Number CRD42015019726, 31/07/2015).The review protocol has been approved by the Children’sand Women’s Hospital, University of British Columbia,Research Ethics Review Board (H15-01404).The following criteria were applied when consideringstudies for this review:Types of studiesThe review will consider studies evaluating theeffectiveness or efficacy of the incorporation of patient’sfertility intentions into their primary care. The studiesmust compare the intervention with no interventionor with a control intervention. Randomized trials,non-randomized trials, and observational studieswill be eligible for inclusion.Types of participantsPatients of reproductive age presenting to primaryhealth care settings, defined as a health care settingthat is the first point of care for undifferentiatedpatients with an undiagnosed condition or concern.Types of interventionsAssessment of fertility intention and follow-up care.Examples include asking patients what their pregnancyor fertility intentions are for the coming year or thedevelopment of a reproductive life plan and subsequentpreconception or contraception counseling, care, and/orreferral as appropriate.Types of outcome measuresResults must include quantitative data for outcomesmeasured.Primary outcomesRates for contraceptive uptake, and any pregnancyrelated outcome, including unwanted pregnancy,unintended pregnancy, mistimed pregnancy, adversepregnancy outcomes, and healthy maternal andnewborn outcomes.Search methods for identification of studiesExtensive searches will be performed by two of the au-thors to collect all relevant studies. We will include bothpeer-reviewed journal articles and the gray literature inour searches. Only the English-language literature willbe included in the searches.Search strategyArticles published since 2000 in English and indexed inthe following databases will be searched: OvidMEDLINE; Pubmed; CINAHL; EMBASE; CDR/DAREdatabases; Web of Science; ISRCTN registry;Clinicaltrials.gov; Cochrane Library. Additionally, thereferences of highly relevant articles will be hand-searched.Keywords and medical subject heading (MeSH) terms willbe used. Additional file 1 shows the main search strategythat will be used for MEDLINE and will be modified forother databases.Data collection and analysisSelection of studiesTitles and/or abstracts of studies retrieved using thesearch strategy and those from hand-searching citationsof highly relevant articles will be screened independentlyby two review authors to identify studies that potentiallymeet the inclusion criteria outlines above. The full textof these potentially eligible studies will be retrieved andindependently assessed for eligibility by two review teammembers. Any disagreement between them over theeligibility of particular studies will be resolved throughdiscussion with a third reviewer.Data extraction and managementReferences will be managed using Thomson ISIResearchSoft EndNote X2 software (Thomson Reuters,New York, NY, USA). A pre-piloted form will be used toextract data from the included studies for assessment ofHenning et al. Systematic Reviews  (2017) 6:11 Page 2 of 4study quality and evidence synthesis (see form in Additionalfile 2). Extracted information will include: study setting;study population and participant demographics and base-line characteristics; details of the interventions and controlconditions; study methodology; recruitment and studycompletion rates; outcomes and times of measurement; in-dicators of acceptability to users; suggested mechanisms ofintervention action; information for assessment of the riskof bias. Two reviewers will extract data independently,discrepancies will be identified and resolved throughdiscussion (with a third author where necessary). Missingdata will be requested from study authors.Assessment of methodological quality in included studiesFor randomized trials, two review authors will independ-ently assess methodological quality in included studiesby considering the following characteristics using theJadad scale [10]: Was the study described as randomized? Was the method of randomization described andappropriate? Was the study described as double blind? Was the method of double blinding described andappropriate? Were withdrawals and dropouts described?For observational and non-randomized trials, two re-view authors will independently assess methodologicalquality using the Newcastle-Ottawa scale. Included casecontrol studies will be assessed by considering the fol-lowing characteristics: Selection of study groups: is the case definitionadequate? Are the cases representative? Fromwhere are controls selected? Are controlsadequately defined? Comparability of groups: are cases and controlscomparable on the basis of the design or analysis?Ascertainment of exposure/outcome: how is theexposure ascertained? Is the same method ofascertainment of exposure used for cases andcontrols? Is the non-response rate the same forcases and controls?Included cohort studies will be assessed by consideringthe following characteristics: Selection: is the exposed cohort representative of thegeneral population? Is the non-exposed cohortdrawn from the same community as the exposedcohort? How is the exposure ascertained? Is itdemonstrated that the outcome of interest was notpresent at the start of the study? Comparability: are the cohorts comparable on thebasis of the design or analysis? Outcome: how is the outcome assessed? Was thefollow-up long enough for outcomes to occur? Wasthe follow-up of cohorts adequate?Disagreements between the review authors over the riskof bias in particular studies will be resolved by discussion,with involvement of a third review author where necessary.Any deviations from the protocol will be acknowledged andjustification for any deviations will be made.Data synthesisWe will provide a text summary of the findings from theincluded studies. We will present the results of thereview by summarizing the approaches to fertilityintention questions that were tested and comparing theireffects on reproductive health outcomes. We willprovide summaries of intervention effects for each studyby calculating risk ratios, prevalence ratios or odds ratios(for dichotomous outcomes), or standardized meandifferences (for continuous outcomes).We anticipate that there will be limited scope formeta-analysis because of the range of different outcomesmeasured across the small number of existing trials.However, where studies have used the same type ofintervention and comparator, with the same outcomemeasure, we will pool the results using a random-effectsmeta-analysis, with standardized mean differences forcontinuous outcomes and risk ratios for binaryoutcomes, and calculate 95% confidence intervals andtwo-sided P values for each outcome.In studies where the effects of clustering have not beentaken into account, we will adjust the standard deviationsfor the design effect. All results will be subject to doubledata entry. We will test for clinical heterogeneity by con-sidering the variability in participant factors among trialsand trial factors. Statistical heterogeneity will be assessedusing the standard Chi-squared (significance level: 01). Ifhigh levels of heterogeneity exist (P < 0.1) the study designand characteristics of the study with be assessed. If lowlevels of heterogeneity exist (P > 0.1) then a meta-analysisas described above will be used to pool the results. Wherestatistical pooling is not possible, the findings will be pre-sented in narrative form including tables and figures toaid in data presentation where appropriate. A funnel plotwill be created by making a scatter plot of the estimatedeffects of the trials identified. Egger’s test will be used toexamine funnel plot asymmetry to investigate possiblepublication or reporting bias [11]. Egger’s test will only beconducted if a minimum of ten studies are includedwithin the meta-analysis.The Preferred Reporting Items for Systematic reviewand Meta-Analysis Protocols (PRISMA-P) checklistHenning et al. Systematic Reviews  (2017) 6:11 Page 3 of 4was used to ensure that appropriate components of asystematic review protocol are included [12] (seeAdditional file 3).DiscussionPlanning for pregnancy has been shown to improvepregnancy outcomes and reduce unintended pregnan-cies. Inclusion of a question of fertility intention intoprimary care encounters may improve the proportionof planned pregnancies and represent a simple andlow-cost intervention to reduce unplanned pregnancies.Planning for pregnancy has been recognized as a signifi-cant public health issue that continues to be poorlyaddressed [9]. This systematic review will provideevidence for practice guidelines regarding the inclusionof questions of fertility intention in primary care settingsand will provide a framework for developing and testingprimary care intervention strategies to support indi-viduals to optimally realize their fertility intentions.Additional filesAdditional file 1: Table S1. MEDLINE search strategy, modified asneeded for other databases (DOCX 482 kb).Additional file 2: Appendix 1. Data Collection Form. Data collectionform used to collect data from review of full text articles (DOCX 489 kb).Additional file 3: PRISMA-P 2015 checklist-Henning.pdf. CompletedPRISMA-P checklist (PDF 115 kb).AbbreviationsICPD: International Conference on Population and Development; PRISMA-P: Preferredreporting items for systematic review and meta-analysis protocols; USPSTF: U.S.Preventive services task forceAcknowledgementsPaul Henning was supported by a Graduate Student Award from the CanadianInstitutes of Health Research Chair in Family Planning Public Health Research.FundingThere was no external funding for this study.Availability of data and materialsAll raw data will made available upon request.Authors’ contributionsPAH and CKB participated in the conception and design of the study,developed the initial search strategy, and collected the background data. PAHprepared the first draft of the manuscript. HEJ and WVN were involved in theconception and design of the study, refinement of search strategy, reviewingdrafts, inputting on methodology and intellectual content. All authors criticallyreviewed the manuscript and approved the final version submitted forpublication. All authors read and approved the final manuscript.Competing interestsThe authors declare that they have no competing interests.Consent for publicationAll sections of this document and the final version of the manuscript havebeen read and approved by each of the contributing authors.Ethics approval and consent to participateThe review protocol has been approved by the Children’s and Women’s Hospital,University of British Columbia, Research Ethics Review Board (H15-01404).Author details1Department of Obstetrics and Gynaecology, University of Calgary, Calgary,Canada. 2School of Population and Public Health, |University of BritishColumbia, Vancouver, Canada. 3School of Public Health & Hunter College,City University of New York (CUNY), NY, USA.Received: 11 December 2015 Accepted: 9 January 2017References1. Brown SS, Eisenberg L, editors. The best intentions: unintended pregnancyand the well-being of children and families. Washington DC: NationalAcademy of Sciences; 1995.2. Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy in theUnited States, 1994 and 2001. Perspect Sex Reprod Health. 2006;38(2):90–6.3. Finer LB, Zolna MR. Shifts in intended and unintended pregnancies in theUnited States, 2001-2008. Am J Public Health. 2014;104 Suppl 1:S43–8.4. Singh S, Sedgh G, Hussain R. Unintended pregnancy: worldwide levels,trends, and outcomes. Stud Fam Plann. 2010;41(4):241–50.5. United Nations: Report on the International Conference on Population andDevelopment. 1995. https://www.unfpa.org/sites/default/files/event-pdf/icpd_eng_2.pdf. Accessed 31 Jul 20156. Gipson JD, Koenig MA, Hindin MJ. The effects of unintended pregnancy oninfant, child, and parental health: a review of the literature. Stud Fam Plann.2008;39(1):18–38.7. Axinn WG, Barber JS, Thornton A. The long-term impact of parents'childbearing decisions on children's self-esteem. Demography. 1998;35(4):435–43.8. Barber JS, Axinn WG, Thornton A. Unwanted childbearing, health, andmother-child relationships. J Health Soc Behav. 1999;40(3):231–57.9. Taylor D, James EA. An evidence-based guideline for unintended pregnancyprevention. J Obstet Gynecol Neonatal Nurs. 2011;40(6):782–93.10. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, etal. Assessing the quality of reports of randomized clinical trials: is blindingnecessary? Control Clin Trials. 1996;17(1):1–12.11. Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysisdetected by a simple, graphical test. BMJ. 1997;315:629–34.12. Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, et al.Preferred reporting items for systematic review and meta-analysis protocols(PRISMA-P) 2015 statement. Syst Rev. 2015;4(1):1.•  We accept pre-submission inquiries •  Our selector tool helps you to find the most relevant journal•  We provide round the clock customer support •  Convenient online submission•  Thorough peer review•  Inclusion in PubMed and all major indexing services •  Maximum visibility for your researchSubmit your manuscript atwww.biomedcentral.com/submitSubmit your next manuscript to BioMed Central and we will help you at every step:Henning et al. Systematic Reviews  (2017) 6:11 Page 4 of 4


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