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IntroductionCurrently, we lack understanding of the content, quality and impact of patient decision aids to support decision-making between medical and surgical methods of early abortion. We plan to undertake a systematic review of peer-reviewed literature to identify, appraise and describe the impact of early abortion method decision aids evaluated quantitatively (Part I), and an environmental scan to identify and appraise other early abortion method decision aids developed in the US (Part II).Methods and analysisFor the systematic review, we will search PubMed, Cochrane Library, CINAHL, EMBASE and PsycINFO databases for articles describing experimental and observational studies evaluating the impact of an early abortion method decision aid on women's decision-making processes and outcomes. For the environmental scan, we will identify decision aids by supplementing the systematic review search with Internet-based searches and key informant consultation. The primary reviewer will assess all studies and decision aids for eligibility, and a second reviewer will also assess a subset of these. Both reviewers will independently assess risk of bias in the studies and abstract data using a piloted form. Finally, both reviewers will assess decision aid quality using the International Patient Decision Aid Standards criteria, ease of readability using Flesch/Flesch-Kincaid tests, and informational content using directed content analysis.Ethics and disseminationAs this study does not involve human subjects, ethical approval will not be sought. We aim to disseminate the findings in a scientific journal, via academic and/or professional conferences and among the broader community to contribute knowledge about current early abortion method decision-making support.Trial registration numberThis protocol is registered in the International Prospective Register of Systematic Reviews (CRD42015016717).

Background There is limited evidence on how to implement shared decision-making (SDM) interventions in routine practice. We conducted a qualitative study, embedded within a 2 × 2 factorial cluster randomized controlled trial, to assess the acceptability and feasibility of two interventions for facilitating SDM about contraceptive methods in primary care and family planning clinics. The two SDM interventions comprised a patient-targeted intervention (video and prompt card) and a provider-targeted intervention (encounter decision aids and training). Methods Participants were clinical and administrative staff aged 18 years or older who worked in one of the 12 clinics in the intervention arm, had email access, and consented to being audio-recorded. Semi-structured telephone interviews were conducted upon completion of the trial. Audio recordings were transcribed verbatim. Data collection and thematic analysis were informed by the 14 domains of the Theoretical Domains Framework, which are relevant to the successful implementation of provider behaviour change interventions. Results Interviews ( n  = 29) indicated that the interventions were not systematically implemented in the majority of clinics. Participants felt the interventions were aligned with their role and they had confidence in their skills to use the decision aids. However, the novelty of the interventions, especially a need to modify workflows and change behavior to use them with patients, were implementation challenges. The interventions were not deeply embedded in clinic routines and their use was threatened by lack of understanding of their purpose and effect, and staff absence or turnover. Participants from clinics that had an enthusiastic study champion or team-based organizational culture found these social supports had a positive role in implementing the interventions. Conclusions Variation in capabilities and motivation among clinical and administrative staff, coupled with inconsistent use of the interventions in routine workflow contributed to suboptimal implementation of the interventions. Future trials may benefit by using implementation strategies that embed SDM in the organizational culture of clinical settings.

Background Women value receiving quality interpersonal care during abortion services, yet no measure exists to assess this outcome from patients’ perspectives. We sought to adapt the Interpersonal Quality in Family Planning care scale (Dehlendorf et al., American Journal of Obstetrics Gynaecology 10.1016/j.ajog.2016.01.173, 2016) for use in abortion care. Methods We adapted items from the original scale for the abortion context, and conducted cognitive interviews to explore the acceptability, understandability, and importance of the adapted items. Adults who spoke English and/or Spanish, had an abortion in the past year, and lived in the US were eligible to participate. Interview memos were analyzed concurrently with data collection to refine the measure in stages. Results We interviewed 26 participants. Items were tested over seven stages and led to four main changes. First, we revised three items to reflect concepts perceived as important to the specific decision-making context of abortion. Second, we removed two items that emerged as potentially inappropriate for this context. Third, we modified language in four items to improve their appropriateness for this context (e.g., ‘telling me’ to ‘explaining’; ‘letting me say’ to ‘listening to’). Fourth, we modified language in three items to improve their clarity. Three items remained unchanged, as there was consistent agreement on their importance, understandability, and relevance. Conclusions The resulting 10-item measure, the Interpersonal Quality in Abortion Care scale, was perceived to be highly important, understandable, and feasible to complete. Future psychometric evaluation can prepare it for use in clinical practice to ensure women feel adequately informed and supported during abortion care.

Mild traumatic brain injury (mTBI) and chronic pain often co-occur and worsen rehabilitation outcomes. There is a need for improved multimodal nonpharmacologic treatments that could improve outcomes for both conditions. Yoga is a promising activity-based intervention for mTBI and chronic pain, and neuromodulation through transcranial magnetic stimulation is a promising noninvasive, nonpharmacological treatment for mTBI and chronic pain. Intermittent theta burst stimulation (iTBS) is a type of patterned, excitatory transcranial magnetic stimulation. iTBS can induce a window of neuroplasticity, making it ideally suited to boost the effects of treatments provided after it. Thus, iTBS may magnify the impacts of subsequently delivered interventions as compared to delivering those interventions alone and accordingly boost their impact on outcomes. The aim of this study is to (1) develop a combined iTBS+yoga intervention for mTBI and chronic pain, (2) assess the intervention's feasibility and acceptability, and (3) gather preliminary clinical outcome data on quality of life, function, and pain that will guide future studies. This is a mixed methods, pilot, open-labeled, within-subject intervention study. We will enroll 20 US military veteran participants. The combined iTBS+yoga intervention will be provided in small group settings once a week for 6 weeks. The yoga intervention will follow the LoveYourBrain yoga protocol-specifically developed for individuals with TBI. iTBS will be administered immediately prior to the LoveYourBrain yoga session. We will collect preliminary quantitative outcome data before and after the intervention related to quality of life (TBI-quality of life), function (Mayo-Portland Adaptability Index), and pain (Brief Pain Inventory) to inform larger studies. We will collect qualitative data via semistructured interviews focused on intervention acceptability after completion of the intervention. This study protocol was approved by Edward Hines Jr Veterans Administration Hospital Institutional Review Board (Hines IRB 1573116-4) and was prospectively registered on ClinicalTrials.gov (NCT04517604). This study includes a Food and Drug Administration Investigational Device Exemption (IDE: G200195). A 2-year research plan timeline was developed. As of March 2022, a total of 6 veterans have enrolled in the study. Data collection is ongoing and will be completed by November 2022. We expect the results of this study to be available by October 2024. We will be able to provide preliminary evidence of safety, feasibility, and acceptability of a novel combined iTBS and yoga intervention for mTBI and chronic pain-conditions with unmet treatment needs. ClinicalTrials.gov NCT04517604; https://www.clinicaltrials.gov/ct2/show/NCT04517604. DERR1-10.2196/37836.

Background The availability and effectiveness of decision aids (DAs) on early abortion methods remain unknown, despite their potential for supporting women's decision making. Objective To describe the availability, impact and quality of DAs on surgical and medical early abortion methods for women seeking induced abortion. Search strategy 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. Inclusion criteria 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. Data extraction and synthesis 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). Results 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. Conclusions 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.

BackgroundThe Standards for Quality Improvement Reporting Excellence (SQUIRE) Guideline was published in 2008 (SQUIRE 1.0) and was the first publication guideline specifically designed to advance the science of healthcare improvement. Advances in the discipline of improvement prompted us to revise it. We adopted a novel approach to the revision by asking end-users to ‘road test’ a draft version of SQUIRE 2.0. The aim was to determine whether they understood and implemented the guidelines as intended by the developers.MethodsForty-four participants were assigned a manuscript section (ie, introduction, methods, results, discussion) and asked to use the draft Guidelines to guide their writing process. They indicated the text that corresponded to each SQUIRE item used and submitted it along with a confidential survey. The survey examined usability of the Guidelines using Likert-scaled questions and participants’ interpretation of key concepts in SQUIRE using open-ended questions. On the submitted text, we evaluated concordance between participants’ item usage/interpretation and the developers’ intended application. For the survey, the Likert-scaled responses were summarised using descriptive statistics and the open-ended questions were analysed by content analysis.ResultsConsistent with the SQUIRE Guidelines’ recommendation that not every item be included, less than one-third (n=14) of participants applied every item in their section in full. Of the 85 instances when an item was partially used or was omitted, only 7 (8.2%) of these instances were due to participants not understanding the item. Usage of Guideline items was highest for items most similar to standard scientific reporting (ie, ‘Specific aim of the improvement’ (introduction), ‘Description of the improvement’ (methods) and ‘Implications for further studies’ (discussion)) and lowest (<20% of the time) for those unique to healthcare improvement (ie, ‘Assessment methods for context factors that contributed to success or failure’ and ‘Costs and strategic trade-offs’). Items unique to healthcare improvement, specifically ‘Evolution of the improvement’, ‘Context elements that influenced the improvement’, ‘The logic on which the improvement was based’, ‘Process and outcome measures’, demonstrated poor concordance between participants’ interpretation and developers’ intended application.ConclusionsUser testing of a draft version of SQUIRE 2.0 revealed which items have poor concordance between developer intent and author usage, which will inform final editing of the Guideline and development of supporting supplementary materials. It also identified the items that require special attention when teaching about scholarly writing in healthcare improvement.

IntroductionDespite the observed and theoretical advantages of shared decision-making in a range of clinical contexts, including contraceptive care, there remains a paucity of evidence on how to facilitate its adoption. This paper describes the protocol for a study to assess the comparative effectiveness of patient-targeted and provider-targeted interventions for facilitating shared decision-making about contraceptive methods.Methods and analysisWe will conduct a 2×2 factorial cluster randomised controlled trial with four arms: (1) video+prompt card, (2) decision aids+training, (3) video+prompt card and decision aids+training and (4) usual care. The clusters will be clinics in USA that deliver contraceptive care. The participants will be people who have completed a healthcare visit at a participating clinic, were assigned female sex at birth, are aged 15–49 years, are able to read and write English or Spanish and have not previously participated in the study. The primary outcome will be shared decision-making about contraceptive methods. Secondary outcomes will be the occurrence of a conversation about contraception in the healthcare visit, satisfaction with the conversation about contraception, intended contraceptive method(s), intention to use a highly effective method, values concordance of the intended method(s), decision regret, contraceptive method(s) used, use of a highly effective method, use of the intended method(s), adherence, satisfaction with the method(s) used, unintended pregnancy and unwelcome pregnancy. We will collect study data via longitudinal patient surveys administered immediately after the healthcare visit, four weeks later and six months later.Ethics and disseminationWe will disseminate results via presentations at scientific and professional conferences, papers published in peer-reviewed, open-access journals and scientific and lay reports. We will also make an anonymised copy of the final participant-level dataset available to others for research purposes.Trial registration numberClinicalTrials.gov Identifier: NCT02759939.