Mack Natasha, Crawford Tineke J, Guise Jeanne-Marie, Chen Mario, Grey Thomas W, Feldblum Paul J, Stockton Laurie L, Gallo Maria F
Research Utilization, FHI 360, 359 Blackwell St, Suite 200, Durham, North Carolina, USA, 27701.
Cochrane Database Syst Rev. 2019 Apr 23;4(4):CD004317. doi: 10.1002/14651858.CD004317.pub5.
Worldwide, hormonal contraceptives are among the most popular reversible contraceptives. Despite high perfect-use effectiveness rates, typical-use effectiveness rates for shorter-term methods such as oral and injectable contraceptives are much lower. In large part, this disparity reflects difficulties in ongoing adherence to the contraceptive regimen and low continuation rates. Correct use of contraceptives to ensure effectiveness is vital to reducing unintended pregnancy.
To determine the effectiveness of strategies aiming to improve adherence to, and continuation of, shorter-term hormonal methods of contraception compared with usual family planning care.
We searched to July 2018 in the following databases (without language restrictions): The Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 7), PubMed via MEDLINE, POPLINE, Web of Science, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP).
We included randomized controlled trials (RCTs) comparing strategies aimed to facilitate adherence and continuation of shorter-term hormonal methods of contraception (such as oral contraceptives (OCs), injectable depot medroxyprogesterone acetate (DMPA or Depo-Provera), intravaginal ring, or transdermal patch) with usual family planning care in reproductive age women seeking to avoid pregnancy.
We used standard methodological procedures recommended by Cochrane. Primary outcomes were continuation or discontinuation of contraceptive method, rates of discontinuation due to adverse events (menstrual disturbances and all other adverse events), and adherence to method use as indicated by missed pills and on-time/late injections. Pregnancy was a secondary outcome.
We included 10 RCTs involving 6242 women. Six trials provided direct in-person counseling using either multiple counseling contacts or multiple components during one visit. Four trials provided intensive reminders of appointments or next dosing, of which two provided additional educational health information as well as reminders. All trials stated 'usual care' as the comparison.The certainty of the evidence ranged from very low to moderate. Main limitations were risk of bias (associated with poor reporting of methodological detail, lack of blinding, and incomplete outcome data), inconsistency, indirectness, and imprecision.Continuation of hormonal contraceptive methodsIt is uncertain whether intensive counseling improves continuation of hormonal contraceptive methods compared with usual care (OR 1.28, 95% CI 1.07 to 1.54; 2624 participants; 6 studies; I = 79%; very low certainty evidence). The evidence suggested: if the chance of continuation with usual care is 39%, the chance of continuation with intensive counseling would be between 41% and 50%. The overall pooled OR suggested continuation of improvement, however, when stratified by contraceptive method type, the positive results were restricted to DMPA.It is uncertain whether reminders (+/- educational information) improve continuation of hormonal contraceptive methods compared with usual care (OR 1.33, 95% CI 1.03 to 1.73; 933 participants; 2 studies; I = 69%; very low certainty evidence).The evidence suggested: if the chance of continuation with usual care is 52%, the chance of continuation with reminders would be between 52% and 65%.Discontinuation due to adverse eventsThe evidence suggested that counseling may be associated with a decreased rate of discontinuation due to adverse events compared with usual care, with a lower rate of discontinuation due to menstrual disturbances (OR 0.20, 95% CI 0.11 to 0.37; 350 participants; 1 study; low certainty evidence), but may make little or no difference to all other adverse events (OR 0.73, 95% CI 0.36 to 1.47; 350 participants; 1 study; low certainty evidence). The evidence suggested: if the chance of discontinuation with usual care due to menstrual disturbances is 32%, the chance of discontinuation with intensive counseling would be between 5% and 15%; and that if the chance of discontinuation with usual care due to other adverse events is 55%, the chance of discontinuation with intensive counseling would be between 30% and 64%.Discontinuation was not reported among trials that investigated the use of reminders (+/- educational information).Adherence Adherence was not reported among trials that investigated the use of intensive counseling.Among trials that investigated reminders (+/- educational information), there was no conclusive evidence of a difference in adherence as indicated by missed pills (MD 0.80, 95% CI -1.22 to 2.82; 73 participants; 1 study; moderate certainty evidence) or by on-time injections (OR 0.84, 95% CI 0.54 to 1.29; 350 participants; 2 studies; I = 0%; low certainty evidence). The evidence suggested: if the chance of adherence to method use as indicated by on-time injections with usual care is 50%, the chance of adherence with method use as indicated by on-time injections with reminders would be between 35% and 56%.PregnancyThere was no conclusive evidence of a difference in rates of pregnancy between intensive counseling and usual care (OR 1.24, 95% CI 0.98 to 1.57; 1985 participants; 3 studies; I = 0%, very low certainty evidence). The evidence suggested: if the chance of pregnancy with usual care is 18%, the chance of pregnancy with counseling would be between 18% and 25%.Pregnancy was not reported among trials that investigated the use of reminders (+/- educational information).
AUTHORS' CONCLUSIONS: Despite the importance of this topic, studies have not been published since the last review in 2013 (nine studies) with only one study added in 2019 that neither changed the results nor improved the certainty of evidence.Overall, the certainty of evidence for strategies to improve adherence and continuation of contraceptives is low. Intensive counseling and reminders (with or without educational information) may be associated with improved continuation of shorter-term hormonal contraceptive methods when compared with usual family planning care. However, this should be interpreted with caution due to the low certainty of the evidence. Included trials used a variety of shorter-term hormonal contraceptive methods which may account for the high heterogeneity. It is possible that the effectiveness of strategies for improving adherence and continuation are contingent on the contraceptive method targeted. There was limited reporting of objectively measurable outcomes (e.g. electronic monitoring device) among included studies. Future trials would benefit from standardized definitions and measurements of adherence, and consistent terminology for describing interventions and comparisons. Further research requires larger studies, follow-up of at least one year, and improved reporting of trial methodology.
在全球范围内，激素避孕法是最常用的可逆避孕方法之一。尽管完美使用有效率很高，但口服和注射避孕等短期避孕方法的实际使用有效率要低得多。在很大程度上，这种差异反映了持续坚持避孕方案的困难以及较低的续用率。正确使用避孕方法以确保有效性对于减少意外怀孕至关重要。
确定与常规计划生育护理相比，旨在提高对短期激素避孕方法的依从性和续用率的策略的有效性。
我们检索了截至2018年7月的以下数据库（无语言限制）：Cochrane对照试验中心注册库（CENTRAL；2018年第7期）、通过MEDLINE检索的PubMed、POPLINE、科学网、ClinicalTrials.gov和国际临床试验注册平台（ICTRP）。
我们纳入了随机对照试验（RCT），这些试验比较了旨在促进短期激素避孕方法（如口服避孕药（OCs）、注射用醋酸甲羟孕酮长效避孕针（DMPA或Depo - Provera）、阴道环或透皮贴剂）的依从性和续用率的策略与寻求避免怀孕的育龄妇女的常规计划生育护理。
我们采用了Cochrane推荐的标准方法程序。主要结局是避孕方法的续用或停用、因不良事件（月经紊乱和所有其他不良事件）导致的停用率以及漏服药物和按时/延迟注射所表明的方法使用依从性。怀孕是次要结局。
我们纳入了10项涉及6242名女性的随机对照试验。6项试验通过多次咨询接触或在一次就诊中使用多个组成部分提供直接的面对面咨询。4项试验提供预约或下次给药的强化提醒，其中2项试验还提供额外的教育健康信息以及提醒。所有试验均将“常规护理”作为对照。证据的确定性范围从极低到中等。主要局限性包括偏倚风险（与方法细节报告不佳、缺乏盲法和结局数据不完整有关）、不一致性、间接性和不精确性。
激素避孕方法的续用
与常规护理相比，强化咨询是否能提高激素避孕方法的续用率尚不确定（OR = 1.28，95%CI 1.07至1.54；2624名参与者；6项研究；I² = 79%；极低确定性证据）。证据表明：如果常规护理下的续用机会为39%，强化咨询下的续用机会将在41%至50%之间。总体合并OR表明有续用改善，但按避孕方法类型分层时，阳性结果仅限于DMPA。
与常规护理相比，提醒（±教育信息）是否能提高激素避孕方法的续用率尚不确定（OR = 1.33，95%CI 1.03至1.73；933名参与者；2项研究；I² = 69%；极低确定性证据）。证据表明：如果常规护理下的续用机会为52%，提醒下的续用机会将在52%至65%之间。
因不良事件导致的停用
证据表明，与常规护理相比，咨询可能与因不良事件导致的停用率降低有关，因月经紊乱导致的停用率较低（OR = 0.20，95%CI 0.11至0.37；350名参与者；1项研究；低确定性证据），但对所有其他不良事件可能影响很小或没有影响（OR = 0.73，95%CI 0.36至1.47；350名参与者；1项研究；低确定性证据）。证据表明：如果常规护理下因月经紊乱而停用的机会为32%，强化咨询下的停用机会将在5%至15%之间；如果常规护理下因其他不良事件而停用的机会为55%，强化咨询下的停用机会将在30%至64%之间。
在调查提醒（±教育信息）使用情况的试验中未报告停用情况。
依从性
在调查强化咨询使用情况的试验中未报告依从性。
在调查提醒（±教育信息）使用情况的试验中，没有确凿证据表明漏服药物（MD = 0.80，95%CI -1.22至2.82；73名参与者；1项研究；中等确定性证据）或按时注射（OR = 0.84，95%CI 0.54至1.29；350名参与者；2项研究；I² = 0%；低确定性证据）所表明的依从性存在差异。证据表明：如果常规护理下按时注射所表明的方法使用依从性机会为50%，提醒下按时注射所表明的方法使用依从性机会将在35%至56%之间。
怀孕
强化咨询与常规护理在怀孕率方面没有确凿证据表明存在差异（OR = 1.24，95%CI 0.98至1.57；1985名参与者；3项研究；I² = 0%，极低确定性证据）。证据表明：如果常规护理下的怀孕机会为18%，咨询下的怀孕机会将在18%至25%之间。
在调查提醒（±教育信息）使用情况的试验中未报告怀孕情况。
尽管该主题很重要，但自上次2013年的综述（9项研究）以来尚未发表新的研究，2019年仅新增了1项研究，该研究既未改变结果也未提高证据的确定性。
总体而言，提高避孕药依从性和续用率策略的证据确定性较低。与常规计划生育护理相比，强化咨询和提醒（有或没有教育信息）可能与短期激素避孕方法的续用改善有关。然而，由于证据的确定性较低，对此应谨慎解释。纳入的试验使用了多种短期激素避孕方法，这可能是异质性高的原因。提高依从性和续用率策略的有效性可能取决于所针对的避孕方法。纳入研究中客观可测量结局（如电子监测设备）的报告有限。未来的试验将受益于依从性的标准化定义和测量，以及描述干预措施和对照的一致术语。进一步的研究需要更大规模的研究、至少一年的随访以及改进试验方法的报告。
