Effect of a decision aid on the choice of pregnant women whether to have epidural anesthesia or not during labor.
ABSTRACT: OBJECTIVE:Decision aids (DAs) are useful in providing information for decision-making on using epidural anesthesia during birth. To date, there has been little development of DAs for Japanese pregnant women. Herein, we investigated the effect of a DA on the decision of pregnant women whether to have epidural anesthesia or not for labor during vaginal delivery. The primary outcome was changes in mean decision conflict score. METHODS:In this non-randomized controlled trial, 300 low-risk pregnant women in an urban hospital were recruited by purposive sampling and assigned to 2 groups: DA (intervention) and pamphlet (control) groups. Control enrollment was started first (until 150 women), followed by intervention enrollment (150 women). Pre-test and post-test scores were evaluated using the Decision Conflict Scale (DCS) for primary outcome, knowledge of epidural anesthesia and satisfaction with decision making for secondary outcomes, and decision of anesthesia usage (i.e., with epidural anesthesia, without epidural anesthesia, or undecided). RESULTS:Women in the DA group (n = 149: 1 excluded because she did not return post-test questionnaire) had significantly lower DCS score than those in the pamphlet group (n = 150) (DA: -8.41 [SD 8.79] vs. pamphlet: -1.69 [SD 5.91], p < .001). Knowledge of epidural anesthesia and satisfaction with decision-making scores of women who used the DA were significantly higher than those of women who used the pamphlet (p < .001). Women in the DA group showed a significantly lower undecided rate than those in the pamphlet group. The number of undecided women in the DA group significantly decreased from 30.2% to 6.1% (p < .001), whereas that in the pamphlet group remained largely unchanged from 40.7% to 38.9%. CONCLUSION:This study indicates that a DA can be useful in helping women make a decision whether to have epidural anesthesia or not for labor during vaginal delivery.
Project description:BACKGROUND: Decision aids may improve informed consent in clinical trial recruitment, but have not been evaluated in this context. This study investigated whether decision aids (DAs) can reduce decisional difficulties among women considering participation in the International Breast Cancer Intervention Study-II (IBIS-II) trial. METHODS: The IBIS-II trial investigated breast cancer prevention with anastrazole in two cohorts: women with increased risk (Prevention), and women treated for ductal carcinoma in situ (DCIS). Australia, New Zealand and United Kingdom participants were randomised to receive a DA (DA group) or standard trial consent materials (control group). Questionnaires were completed after deciding about participation in IBIS-II (post decision) and 3 months later (follow-up). RESULTS: Data from 112 Prevention and 34 DCIS participants were analysed post decision (73 DA; 73 control); 95 Prevention and 24 DCIS participants were analysed at follow-up (58 DA; 61 control). There was no effect on the primary outcome of decisional conflict. The DCIS-DA group had higher knowledge post decision, and the Prevention-DA group had lower decisional regret at follow-up. CONCLUSIONS: This was the first study to evaluate a DA in the clinical trial setting. The results suggest DAs can potentially increase knowledge and reduce decisional regret about clinical trial participation.
Project description:BACKGROUND:We previously developed a pamphlet decision aid (DA) on mammography screening for women ??75 years. However, implementing DAs in primary care may be challenging and may require support from non-physician healthcare team members. OBJECTIVE:To learn from primary care administrators, nurses, and staff their thoughts on how best to implement a mammography DA for women ??75 years in practice. DESIGN:Qualitative study entailing in-person individual interviews using a semi-structured interview guide. PARTICIPANTS:Thirty-two non-physician healthcare team members (69.6% of those approached) participated from 8 different primary care practices (community and academic) in the Boston area or in Chapel Hill, NC. APPROACH:Participants were asked to provide feedback on the DA, their thoughts on ways to make the DA available to older women, and factors that would make it easier and/or harder to implement. KEY RESULTS:Participants felt the DA was clear, balanced, and understandable, but felt that it needed to be shorter for women with low health literacy. Most participants felt that as long as use of the DA was approved and supported by clinicians that women ??75 years should receive the DA before a visit from staff (usually medical assistants) so that patients could ask their clinicians questions during the visit. Facilitators of DA use included its perceived helpfulness with decision-making, its format, and that existing systems (panel management, electronic medical record alerts) could be accessed to get the DA to patients especially at Medicare Annual Wellness visits. Participants perceived a need for training, albeit minimal, to provide the DA to patients. Barriers of DA use included competing demands on clinician and staff time. CONCLUSIONS:Participants felt that as long as use of the mammography DA for women ??75 years was supported by clinicians, it would be feasible to implement with minimal refinements to existing healthcare system processes.
Project description:<h4>Background</h4>The availability and effectiveness of decision aids (DAs) on early abortion methods remain unknown, despite their potential for supporting women's decision making.<h4>Objective</h4>To describe the availability, impact and quality of DAs on surgical and medical early abortion methods for women seeking induced abortion.<h4>Search strategy</h4>For the systematic review, we searched MEDLINE, Cochrane Library, CINAHL, EMBASE and PsycINFO. For the environmental scan, we searched Google and App Stores and consulted key informants.<h4>Inclusion criteria</h4>For the systematic review, we included studies evaluating an early abortion method DA (any format and language) vs a comparison group on women's decision making. DAs must have met the Stacey et al (2014). Cochrane review definition of DAs. For the environmental scan, we included English DAs developed for the US context.<h4>Data extraction and synthesis</h4>We extracted study and DA characteristics, assessed study quality using the Effective Practice and Organization of Care risk of bias tool and assessed DA quality using International Patient Decision Aid Standards (IPDAS).<h4>Results</h4>The systematic review identified one study, which found that the DA group had higher knowledge and felt more informed. The evaluated DA met few IPDAS criteria. In contrast, the environmental scan identified 49 DAs created by non-specialists. On average, these met 28% of IPDAS criteria for Content, 22% for Development and 0% for Effectiveness.<h4>Conclusions</h4>Research evaluating DAs on early abortion methods is lacking, and although many tools are accessible, they demonstrate suboptimal quality. Efforts to revise existing or develop new DAs, support patients to identify high-quality DAs and facilitate non-specialist developers' adoption of best practices for DA development are needed.
Project description:Epidural analgesia represents one of the most effective pharmacological ways to relieve labour pain. Women's awareness regarding the use of epidurals is increasing. As the decision to use epidural analgesia during labour is affected by many social, personal and medical factors, this study aimed to explore the factors contributing to a pregnant women's decision to use epidurals and to understand the benefit of implementing a health education program regarding epidural analgesia.A cross-sectional study was conducted with primigravid women visiting the Obstetric Clinics for their routine antenatal care at King Abdul-Aziz Medical City in Riyadh from October 2014 to December 2016. The participating pregnant women were educated on the use of epidural analgesia during labour by a professional health educator utilizing specially designed educational materials. We assessed the relationship between the women's decision to request epidural analgesia and their age, place of residence, occupation, income and education level using a questionnaire.A total of 81 primigravid women were included in the study. Employed pregnant women were more likely to request epidural analgesia than non-employed women (46.7% vs. 18.2%, P?=?0.019). After education, significantly more pregnant women were planning to request epidurals (mean score for answers before education was 2.12?±?0.578 vs. 2.27?±?0.592 after education, P?=?0.013). Other variables, such as age, level of education, income and place of residence were not significantly associated with the participants' decision to request epidural analgesia.Health education on epidural analgesia is an important factor in increasing primigravid women's desire to request epidural analgesia. Education on epidural analgesia during antenatal care is needed for better decision making regarding the use of epidural analgesia during labour.
Project description:BACKGROUND:Loss of resistance (LOR) technique is a widely used method to identify the epidural space. However, cases of inadequate epidural anesthesia in cesarean section were frequently reported. Also, the success rate of epidural anesthesia with LOR technique varied depending on the proficiency of the practitioner. The purpose of this study was to assess the efficacy and safety of electrical stimulation to identify epidural spaces in cesarean section for novices or clinicians with recent gap in experience. METHODS:Pregnant women scheduled for elective cesarean section were randomly allocated to two groups. Groups were classified based on the methods used for identifying the epidural space: the LOR group (group L) and the LOR with epidural electrical stimulation group (group E). Clinicians with less than 10 epidural cesarean section experiences in the recent year performed epidural anesthesia for cesarean section. In the group E, a RegionalStim® conductive catheter was inserted through the Tuohy needle, and the guidewire passing through the catheter was connected to a peripheral nerve stimulator. The intensity of the stimulation was gradually increased from 0.25?mA to 1.5?mA until paresthesia was elicited and radiated. We assessed the success of epidural anesthesia (complete success, partial success or failure). Other clinical parameters including maternal satisfaction, time required for epidural anesthesia, neonatal Apgar scores, pain scores and adverse events were compared between the two groups. RESULTS:Except for 6 patients who withdrew consent, 54 patients were enrolled in this study (28 for the group L and 26 for the group E). The demographic data showed no difference between the two groups. There was no adverse event resulted from electrical stimulation. The group E showed higher rate of complete success, sensitivity in finding epidural space and maternal satisfaction compared to the group L (21/26 vs. 15/28, p?=?0.034, 0.96 vs. 0.68, p?=?0.012 and 4.04 vs. 3.39, p?=?0.02, respectively). The other clinical parameters showed no differences between the two groups. CONCLUSION:In addition to the conventional LOR technique, identifying epidural spaces using electrical stimulation led to better outcomes without additional risks for novices as well as clinicians with recent gap in experience. TRIAL REGISTRATION:This study was retrospectively registered in the ClinicalTrials.gov Registry (NCT03443466) on February 23, 2018.
Project description:Up to 40% of women gain excessive weight during pregnancy. Obesity complications and risks in parturient women undergoing cesarean section (CS) with different anesthetic methods remain unknown. This study aimed to assess the safety and risk of obese women undergoing CS delivery with various perioperative anesthetic methods.Seven hundred ninety parturient women underwent CS under general anesthesia (GA), intraspinal anesthesia including epidural anesthesia (EA) and combined spinal-epidural anesthesia (CSEA). They were divided into morbid (n?=?255), severe (n?=?274), and non-obesity (n?=?261) groups. This study is registered with ClinicalTrials.gov (number NCT03002636).Between 2013 and 2016, 790 pregnant were assessed. Compared with the non-obesity group, there were significantly more fetal distress and higher body mass index (BMI) in the morbid obesity group (P?=?.0001 and P?=?.001, respectively). Significantly more patients showed preeclampsia, multifetation, amniotic fluid abnormality, and high bleeding amounts in the morbid obesity group compared with the non-obesity group (P?=?.0001, P?=?.048, P?=?.017, and P?=?.018, respectively); more patients were administered EA and GA compared with the non-obesity group (P?=?.0001 and P?=?.0001, respectively). More post-anesthesia care unit (PACU) patients were found in the severe obesity group no more than the non-obesity group. Significantly increased anesthesia puncture times for 5?>?n???3 and n???5 were obtained in the morbid obesity group (P?=?.0001 and P?=?.0001, respectively), with more patients in the puncture sitting position, compared with the non-obesity group (P?=?.0001).GA, EA, and CSEA are safe and effective in severely or morbidly obese patients. Morbidly obese parturient show increased likelihood for fetal distress, PACU, sitting position puncture, puncture difficulty, and other pregnancy complications. There were more anesthesia puncture times in morbidly obese patients.
Project description:BACKGROUND:Australian clinicians are advised to 'offer evidence-based decisional support to men considering whether or not to have a PSA test'. This randomised trial compared the performance and acceptability of two new decision aids (DAs) to aid men in making informed choices about PSA screening. METHODS:~3000 Australian men 45-60 years with varying educational attainment were recruited via an online panel and randomised to view one of two online decision aids (one full length, one abbreviated) and completed a questionnaire. The primary outcome was informed choice about PSA screening. FINDINGS:Significantly more men in the long DA group (38%) made an informed choice than men who received the shorter DA (33%) (95% CI 1.1% to 8.2%; p = 0.008). On knowledge, the long DA group scored, on average, 0.45 points higher than the short DA group (95% CI 0.14 to 0.76; p = 0.004) and 5% more of the participants achieved an adequate knowledge score (95% CI 1.9% to 8.8%; p = 0.002). Men allocated the long DA were less likely to intend to have a PSA test in the future (53%) than men in the short DA group (59%). Both DAs rated highly on acceptability. CONCLUSIONS:Both DAs were useful and acceptable to men regardless of education level and both supported informed decision making. The long version resulted in higher knowledge, and a higher proportion of men able to make an informed choice, but the differences were small. Long DAs may be useful for men whose informational needs are not satisfied by a short DA.
Project description:Background. There are many patient decision aids (DAs) available, yet there is limited evidence on comparative effectiveness of different tools. Objective. To examine feasibility of a study protocol and gather preliminary data on comparative effectiveness. Methods. Adult patients seeing a surgeon to discuss treatment for hip or knee osteoarthritis were randomized to hip and knee DAs from two vendors. Pre-visit survey included Hip/Knee Decision Quality Instrument, DA usage, health literacy, and quality of life (EQ-5D). Surgical status was ascertained 6 months post-visit. We examined response rates, eligibility, and compared the two DAs on amount of use, knowledge scores, and receipt of preferred treatment. Results. Overall response rate was 58/74 (78%) and did not differ by study arm. More patients in DA-A group reported reviewing all the DAs (64.5% DA-A v. 24.0% DA-B, P = 0.003). Knowledge scores were similar across arms (55.2% DA-A v. 48.8% DA-B, P = 0.4). For DA-B, knowledge scores were higher for those who reviewed all the DAs compared with those who did not (80% knowledge v. 39% knowledge, respectively, P = 0.004), while scores for DA-A did not vary by usage (62% knowledge v. 53% knowledge, respectively, P = 0.3). A similar percentage of each group received their preferred treatment (77% v. 73%, P = 0.8). Patients who were unsure about preferred treatment at baseline were more likely to have surgery in the DA-A arm compared with the DA-B arm (55% v. 20%, P = 0.1). Limitations. Small sample; patients were only surveyed pre-visit. Conclusion. Despite having different content and formats, the two DAs had similar overall effectiveness. Patients were more likely to review all of DA-A; however, patients who reviewed all of DA-B had the highest knowledge scores.
Project description:Women choosing breast cancer surgery encounter treatment decision-making (TDM) difficulties, which can cause psychological distress. Decision Aids (DAs) may facilitate TDM, but there are no DAs designed for Chinese populations. We developed a DA for Chinese women newly diagnosed with breast cancer, for use during the initial surgical consultation.Conduct a pilot study to assess the DA acceptability and utility among Chinese women diagnosed with breast cancer.Women preferred the DA in booklet format. A booklet was developed and revised and evaluated in two consecutive pilot studies (P1 and P2). On concluding their initial diagnostic consultation, 95 and 38 Chinese women newly diagnosed with breast cancer received the draft and revised draft DA booklet, respectively. Four-day post-consultation, women had questionnaires read out to them and to which they responded assessing attitudes towards the DA and their understanding of treatment options.The original DA was read/partially read by 66/22% (n = 84) of women, whilst the revised version was read/partially read by 74/16% (n = 35), including subliterate women (?(2) = 0.76, P = 0.679). Knowledge scores varied with the extent the booklet was read (P1: F = 12.68, d.f. 2, P < 0.001; P2: F = 3.744, d.f. 2, P = 0.034). The revised, shorter version was graphically rich and resulted in improved perceived utility, [except for the 'treatment options' (?(2) = 5.50, P = 0.019) and 'TDM guidance' (?(2) = 8.19, P = 0.004) sections] without increasing anxiety (F = 0.689, P = 0.408; F = 3.45, P = 0.073).The DA was perceived as acceptable and useful for most women. The DA effectiveness is currently being evaluated using a randomized controlled trial.
Project description:PURPOSE:There is insufficient evidence to recommend mammography for women >75 years. Guidelines recommend that older women be informed of the uncertainty of benefit and potential for harm, especially for women with short life expectancy. However, few older women are informed of harms of screening and many with short life expectancy are screened. Therefore, we aim to test whether a mammography screening decision aid (DA) for women >75 years affects their use of mammography, particularly for women with <10 year life expectancy. METHODS/DESIGN:The DA is a self-administered pamphlet that includes information on screening outcomes, tailored information on breast cancer risk, health, life expectancy, and competing mortality risks, and includes a values clarification exercise. We are conducting a large cluster randomized controlled trial (RCT) of the DA with the primary care provider (PCP) as the unit of randomization to evaluate its efficacy. We plan to recruit 550 women 75-89 years from 100 PCPs to receive either the mammography DA or a pamphlet on home safety for older adults (control arm) before a visit with their PCP, depending on their PCP's randomization assignment. The primary outcome is receipt of mammography screening assessed through chart abstraction. Secondary outcomes include effect of the DA on older women's screening intentions, knowledge, and decisional conflict, and on documented discussions about mammography by their PCPs. We will recruit women from 5 Boston-based primary care practices (3 community-based internal medicine practices and 2 academic practices), and 2 North Carolina-based academic primary care practices. DISCUSSION:It is essential that we test the DA in a large RCT to determine if it is efficacious and to substantiate the need for broad translation into clinical practice. Our DA has the potential to improve health care utilization and care in a manner dictated by patient preferences.