Lopez Laureen M, Grey Thomas W, Chen Mario, Tolley Elizabeth E, Stockton Laurie L
Clinical and Epidemiological Sciences, FHI 360, 359 Blackwell St, Suite 200, Durham, North Carolina, USA, 27701.
Cochrane Database Syst Rev. 2016 Nov 23;11(11):CD007249. doi: 10.1002/14651858.CD007249.pub5.
The explicit use of theory in research helps expand the knowledge base. Theories and models have been used extensively in HIV-prevention research and in interventions for preventing sexually transmitted infections (STIs). The health behavior field uses many theories or models of change. However, many educational interventions addressing contraception have no explicit theoretical base.
To review randomized controlled trials (RCTs) that tested a theoretical approach to inform contraceptive choice and encourage or improve contraceptive use.
To 1 November 2016, we searched for trials that tested a theory-based intervention for improving contraceptive use in PubMed, CENTRAL, POPLINE, Web of Science, ClinicalTrials.gov, and ICTRP. For the initial review, we wrote to investigators to find other trials.
Included trials tested a theory-based intervention for improving contraceptive use. Interventions addressed the use of one or more methods for contraception. The reports provided evidence that the intervention was based on a specific theory or model. The primary outcomes were pregnancy and contraceptive choice or use.
We assessed titles and abstracts identified during the searches. One author extracted and entered the data into Review Manager; a second author verified accuracy. We examined studies for methodological quality.For unadjusted dichotomous outcomes, we calculated the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI). Cluster randomized trials used various methods of accounting for the clustering, such as multilevel modeling. Most reports did not provide information to calculate the effective sample size. Therefore, we presented the results as reported by the investigators. We did not conduct meta-analysis due to varied interventions and outcome measures.
We included 10 new trials for a total of 25. Five were conducted outside the USA. Fifteen randomly assigned individuals and 10 randomized clusters. This section focuses on nine trials with high or moderate quality evidence and an intervention effect. Five based on social cognitive theory addressed preventing adolescent pregnancy and were one to two years long. The comparison was usual care or education. Adolescent mothers with a home-based curriculum had fewer second births in two years (OR 0.41, 95% CI 0.17 to 1.00). Twelve months after a school-based curriculum, the intervention group was more likely to report using an effective contraceptive method (adjusted OR 1.76 ± standard error (SE) 0.29) and using condoms during last intercourse (adjusted OR 1.68 ± SE 0.25). In alternative schools, after five months the intervention group reported more condom use during last intercourse (reported adjusted OR 2.12, 95% CI 1.24 to 3.56). After a school-based risk-reduction program, at three months the intervention group was less likely to report no condom use at last intercourse (adjusted OR 0.67, 95% CI 0.47 to 0.96). The risk avoidance group (abstinence-focused) was less likely to do so at 15 months (OR 0.61, 95% CI 0.45 to 0.85). At 24 months after a case management and peer-leadership program, the intervention group reported more consistent use of hormonal contraceptives (adjusted relative risk (RR) 1.30, 95% CI 1.06 to 1.58), condoms (RR 1.57, 95% CI 1.28 to 1.94), and dual methods (RR 1.36, 95% CI 1.01 to 1.85).Four of the nine trials used motivational interviewing (MI). In three studies, the comparison group received handouts. The MI group more often reported effective contraception use at nine months (OR 2.04, 95% CI 1.47 to 2.83). In two studies, the MI group was less likely to report using ineffective contraception at three months (OR 0.31, 95% CI 0.12 to 0.77) and four months (OR 0.56, 95% CI 0.31 to 0.98), respectively. In the fourth trial, the MI group was more likely than a group with non-standard counseling to initiate long-acting reversible contraception (LARC) by one month (OR 3.99, 95% CI 1.36 to 11.68) and to report using LARC at three months (OR 3.38, 95% CI 1.06 to 10.71).
AUTHORS' CONCLUSIONS: The overall quality of evidence was moderate. Trials based on social cognitive theory focused on adolescents and provided multiple sessions. Those using motivational interviewing had a wider age range but specific populations. Sites with low resources need effective interventions adapted for their settings and their typical clients. Reports could be clearer about how the theory was used to design and implement the intervention.
研究中明确运用理论有助于扩大知识基础。理论和模型已广泛应用于艾滋病预防研究以及预防性传播感染(STIs)的干预措施中。健康行为领域运用了许多变革理论或模型。然而,许多针对避孕的教育干预措施并无明确的理论基础。
回顾随机对照试验(RCTs),这些试验检验了一种理论方法,以指导避孕选择并鼓励或改善避孕措施的使用。
截至2016年11月1日,我们在PubMed、CENTRAL、POPLINE、科学网、ClinicalTrials.gov和ICTRP中检索了检验基于理论的干预措施以改善避孕措施使用情况的试验。对于初步综述,我们写信给研究者以查找其他试验。
纳入的试验检验了基于理论的干预措施以改善避孕措施的使用。干预措施涉及一种或多种避孕方法的使用。报告提供了证据表明该干预措施基于特定理论或模型。主要结局为妊娠以及避孕选择或使用情况。
我们评估了检索过程中识别出的标题和摘要。一位作者提取数据并录入Review Manager;另一位作者核实准确性。我们检查研究的方法学质量。对于未经调整的二分结局,我们计算Mantel-Haenszel比值比(OR)及95%置信区间(CI)。整群随机试验采用了多种考虑聚类的方法,如多水平建模。大多数报告未提供计算有效样本量的信息。因此,我们按照研究者报告的结果呈现。由于干预措施和结局测量方法各异,我们未进行Meta分析。
我们纳入了10项新试验,共计25项试验。其中5项在美国境外开展。15项随机分配个体试验和10项随机整群试验。本节重点关注9项具有高质量或中等质量证据且有干预效果的试验。5项基于社会认知理论开展的试验旨在预防青少年妊娠且为期一到两年。对照为常规护理或教育。接受家庭课程的青少年母亲在两年内二胎生育较少(OR 0.41,95%CI 0.17至1.00)。基于学校课程开展12个月后,干预组更有可能报告使用有效避孕方法(调整后OR 1.76±标准误(SE)0.29)以及在上次性交时使用避孕套(调整后OR 1.68±SE 0.25)。在替代学校中,5个月后干预组报告在上次性交时更多使用避孕套(报告的调整后OR 2.12,95%CI 1.24至`3.56)。在基于学校的降低风险项目开展3个月后,干预组在上次性交时报告未使用避孕套的可能性较小(调整后OR 0.67,95%CI 0.47至0.96)。风险规避组(以禁欲为重点)在15个月时这样做的可能性较小(OR 0.61,95%CI 0.45至0.85)。在病例管理和同伴引领项目开展24个月后,干预组报告更持续使用激素避孕方法(调整后相对风险(RR)1.30,95%CI 1.06至1.58)、避孕套(RR 1.57,95%CI 1.28至1.94)以及双重方法(RR 1.36,95%CI 1.01至1.85)。9项试验中有4项采用了动机性访谈(MI)。在3项研究中,对照组收到宣传资料。MI组在9个月时更常报告有效避孕措施的使用(OR 2.04,95%CI 1.47至2.83)。在2项研究中,MI组在3个月(OR 0.31,95%CI 0.12至0.77)和4个月(OR 0.56,95%CI 0.31至0.98)时报告使用无效避孕措施的可能性较小。在第4项试验中,MI组比非标准咨询组更有可能在1个月时开始使用长效可逆避孕方法(LARC)(OR 3.99,95%CI 1.36至11.68),并在3个月时报告使用LARC(OR 3.38,95%CI 1.06至10.71)。
证据的总体质量为中等。基于社会认知理论的试验聚焦于青少年且提供多节课程。采用动机性访谈方法的试验年龄范围更广但针对特定人群。资源匮乏地区需要适合其环境和典型服务对象的有效干预措施。报告应更清晰地说明理论如何用于设计和实施干预措施。