LoveYourBrain Mindset: Feasibility, Acceptability, Usability, and Effectiveness of an Online Yoga, Mindfulness, and Psychoeducation Intervention for People with Traumatic Brain Injury.

OBJECTIVE: Despite the benefits of yoga, mindfulness, and psychoeducation after traumatic brain injury (TBI), no online programming exists. This study investigated the feasibility, acceptability, usability, and effectiveness of the LoveYourBrain Mindset online program for people with TBI. RESEARCH DESIGN: Pre-post, retrospective intervention. METHODS: LoveYourBrain Mindset is a six-week online yoga, mindfulness, and psychoeducation program with weekly interactive Zoom classes and prerecorded mindfulness tools. Two interactive class types (45-minute group discussion, 75-minute group discussion and gentle yoga) are offered to enhance accessibility. People were eligible if they experienced TBI, were a caregiver, or clinician; ≥15 years old; and capable of gentle exercise and group discussion. We analyzed attendance, program ratings, mindfulness tools utilization, and pre/post-intervention differences in QOL, resilience, emotional/behavioral dysregulation, cognition, and positive affect/well-being. RESULTS: Overall, 1539 individuals signed up for LoveYourBrain Mindset with 1093 (71.02%) participating in one/more classes. The mean program rating was 9.09 (SD=1.28). Majority (62.99%) used the mindfulness tools each week. Multiple linear regression models controlling for age, TBI severity, and gender indicated significant improvements in QOL, resilience, emotional/behavioral dysregulation, cognition, and positive affect/well-being (p<0.001). CONCLUSION: LoveYourBrain Mindset is feasible, acceptable, usable, and may improve outcomes among people with TBI.

The feasibility, acceptability, and effectiveness of the multimodal, community-based LoveYourBrain Retreat program for people with traumatic brain injury and caregivers.

PURPOSE: To evaluate the feasibility, acceptability, and effectiveness of the LoveYourBrain Retreat program using a pre-post, retrospective, concurrent triangulation mixed methods study. MATERIALS AND METHODS: A 5-day, multimodal, residential Retreat intervention was designed to improve quality of life among traumatic brain injury (TBI) survivors and caregivers through mindfulness, movement, nutrition, art, and community-building. Eligibility included being a TBI survivor (>2 years post-injury) or caregiver, 18+ years old, independently mobile, able to communicate verbally, and a first-time participant. Self-reported quantitative and qualitative data were collected via electronic surveys pre- and post-retreat, analyzed separately, then combined. Paired t-tests assessed mean differences in scores on Quality of Life After Brain Injury Overall scale (QOLIBRI-OS) and NIH TBI/Neuro-QOL Resilience, Cognition, Positive Affect/Wellbeing, and Emotional/Behavioral Dysregulation scales. We assessed feasibility using sample characteristics and program frequency and retention, and acceptability using quality ratings. Content analysis explored perceived benefits and improvements. RESULTS: 68 People-53 with TBI and 15 caregivers-participated in one of three LoveYourBrain Retreats. Significant improvements were found in QOLIBRI-OS (6.91, 95%CI 1.88-11.94), Resilience (2.14, 95%CI 0.50-3.78), Cognition (2.81, 95%CI 0.79-4.83), and Emotional/Behavioral Dysregulation (2.84, 95%CI 0.14-5.54) among TBI survivors (n = 41). Mean satisfaction was 9.6/10 (SD = 0.64). Content analysis revealed community connection, reframing TBI experience, self-regulation, and self-care themes. CONCLUSIONS: The LoveYourBrain Retreat is feasible, acceptable, and may be effective complementary rehabilitation to improve QOL among TBI survivors.

Ongoing, holistic rehabilitation services are critical to quality of life for people with chronic traumatic brain injury (TBI).Residential retreats are a type of holistic, multimodal, community-based rehabilitation.LoveYourBrain Retreats improved quality of life, resilience, cognition, and emotional dysregulation among people with TBI.The integration of community connection, reframing TBI experience, self-regulation, and self-care may support adjustment to TBI.

A crossover pilot trial of the feasibility, acceptability, and effectiveness of LoveYourBrain Yoga for community-dwelling adults with multiple sclerosis.

BACKGROUND AND PURPOSE: Among people with multiple sclerosis (MS), yoga has potential to improve fatigue and other symptoms that undermine quality of life. The aim of this study was to assess the feasibility, acceptability, and effectiveness of LoveYourBrain Yoga, a six-week yoga with psychoeducation program, on fatigue and other health-related outcomes among people with MS in a rural, community-based setting in the United States. METHODS: This non-randomized 2x2 crossover pilot trial compared LoveYourBrain Yoga to a control among 15 people with MS. People were eligible if they were adults with MS (EDSS score ≤6), English-speaking, and ambulatory. Paired t-tests and Wilcoxon signed rank sum analyses assessed mean differences in PROMIS-FatigueMS, Multiple Sclerosis Impact Scale, Symbol Digit Modalities Test, NIH Neuro-QoL measures, and Liverpool Self-Efficacy scale. We assessed feasibility using recruitment and retention rates, mean attendance, fidelity, and acceptability using satisfaction measures. RESULTS: Significant improvements in fatigue (MD -4.34, SD 5.26, p = 0.012), positive affect and wellbeing (MD 2.76, SD 3.99, p = 0.028), and anxiety (MD -4.42, SD 5.36, p = 0.012) were found after LoveYourBrain Yoga compared to the control. Participants reported high satisfaction (M 9.5, SD 1.4) and a majority (92.3%) reported 'Definitely, yes' to recommending it to a friend or family. CONCLUSION: LoveYourBrain Yoga is feasible and acceptable when implemented in a rural, community-based setting for people with MS. It may improve a range of MS symptoms and offer a means for acquiring new skills for stress reduction, anxiety management, and overall wellbeing.

Feasibility of a Combined Neuromodulation and Yoga Intervention for Mild Traumatic Brain Injury and Chronic Pain: Protocol for an Open-label Pilot Trial.

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT04517604; https://www.clinicaltrials.gov/ct2/show/NCT04517604. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37836.

A retrospective study on the acceptability, feasibility, and effectiveness of LoveYourBrain Yoga for people with traumatic brain injury and caregivers.

PURPOSE: To conduct a mixed methods, pre-post, retrospective study on the feasibility, acceptability, and effectiveness of the LoveYourBrain Yoga program. MATERIALS AND METHODS: People were eligible if they were a traumatic brain injury survivor or caregiver, age 15-70, ambulatory, and capable of gentle exercise and group discussion. We analyzed attendance, satisfaction, and mean differences in scores on Quality of Life After Brain Injury Overall scale (QOLIBRI-OS) and four TBI-QOL/Neuro-QOL scales. Content analysis explored perceptions of benefits and areas of improvement. RESULTS: 1563 people (82.0%) participated ≥1 class in 156 programs across 18 states and 3 Canadian provinces. Mean satisfaction was 9.3 out of 10 (SD 1.0). Mixed effects linear regression found significant improvements in QOLIBRI-OS (B 9.70, 95% CI: 8.51, 10.90), Resilience (B 1.30, 95% CI: 0.60, 2.06), Positive Affect and Well-being (B 1.49, 95% CI: 1.14, 1.84), and Cognition (B 1.48, 95% CI: 0.78, 2.18) among traumatic brain injury survivors (n = 705). No improvement was found in Emotional and Behavioral Dysregulation, however, content analysis revealed better ability to regulate anxiety, anger, stress, and impulsivity. Caregivers perceived improvements in physical and psychological health. CONCLUSIONS: LoveYourBrain Yoga is feasible and acceptable and may be an effective mode of community-based rehabilitation.IMPLICATIONS FOR REHABILITATIONPeople with traumatic brain injury and their caregivers often experience poor quality of life and difficulty accessing community-based rehabilitation services.Yoga is a holistic, mind-body therapy with many benefits to quality of life, yet is largely inaccessible to people affected by traumatic brain injury in community settings.Participants in LoveYourBrain Yoga, a six-session, community-based yoga with psychoeducation program in 18 states and 3 Canadian provinces, experienced significant improvements in quality of life, resilience, cognition, and positive affect.LoveYourBrain Yoga is feasible and acceptable when implemented on a large scale and may be an effective mode of, or adjunct to, community-based rehabilitation.

Best Practices for Adapting and Delivering Community-Based Yoga for People with Traumatic Brain Injury in the United States and Canada.

Emerging benefits of yoga for traumatic brain injury (TBI) suggest that broader accessibility to community-based yoga programming is important. This cross-sectional, mixed methods study sought to identify best practices for adapting and delivering community-based yoga to people with TBI. An online survey was sent to 175 yoga teachers trained to teach LoveYourBrain Yoga, a community-based, 6-week, manualized program for people with TBI and their care-givers. The survey instrument included open- and closed-text questions assessing teachers' perspectives on the most and least helpful adaptions for asana, meditation, pranayama, and group discussion, and on the LoveYourBrain Yoga training and support. Responses we re analyzed using d e s c r i p t i ve statistics and qualitative content analysis. Eighty-six teachers (50%) responded. Best practices for adapting yoga for TBI revealed six themes: (1) simple, slow, and repeated; (2) creating a safe space; (3) position of the head and neck; (4) demonstration; (5) importance of props; and (6) special considerations for yoga studios. Three themes emerged for yoga program delivery: (1) structured yet flexible; (2) acceptability of compensation; and (3) time management. Eighty-nine percent of teachers reported that the program manual was very/extremely helpful, yet nearly half (49%) adapted the manual content often/always. To deliver community-based yoga services for TBI, we recommend an environment with props, low light and noise, and sufficient space, along with the facilitation of consistent instruction with a manual that allows for flexibility. We recommend that yoga teachers have skills in physical modifications for the head and neck; slow, simple, and repeated cueing to facilitate cognitive processing; managing challenging behaviors through redirection techniques; and promoting safety through inclusivity, compassion, and personal agency.

A qualitative study of LoveYourBrain Yoga: a group-based yoga with psychoeducation intervention to facilitate community integration for people with traumatic brain injury and their caregivers.

Purpose: To explore participants' experiences in a group-based yoga with psychoeducation intervention designed to facilitate community integration for people with traumatic brain injury and their caregivers.Materials and methods: We conducted semi-structured interviews with 13 people with traumatic brain injury and three caregivers who had completed LoveYourBrain Yoga, a 6-session, manualized, group-based yoga intervention that incorporates breathing exercises, yoga, meditation, and psychoeducation. Interviews were analyzed using content analysis.Results: We identified seven themes: ease of participation, belonging, sustaining community connection, physical health, self-regulation, self-efficacy, and resilience. All participants valued the community-based yoga studio environment and multifaceted structure of the program. Participants reported improvements in strength, balance, flexibility, and attention control, and a greater sense of belonging, community connection, and ability to move forward with their lives. Participants reported ongoing use of tools (e.g., breathing exercises) to cope with negative emotions and stress. About half of participants sustained relationships built during LoveYourBrain Yoga and felt more capable of accessing other activities in their community.Conclusions: LoveYourBrain Yoga successfully promoted community integration for people with traumatic brain injury. It also facilitated diverse and meaningful physical, psychological, and social health benefits, which suggest that it may be an effective mode of community-based rehabilitation.Implications for rehabilitationTraumatic brain injury survivors often struggle to participate in their community, the ultimate goal of rehabilitationYoga is a holistic therapy with many benefits, yet is not accessible to the traumatic brain injury population at the community levelParticipants in a community-based yoga with psychoeducation intervention in six states experienced diverse and meaningful physical, psychological, and social health benefitsGroup-based yoga with psychoeducation may be an effective mode of community integration and community-based rehabilitation for traumatic brain injury survivors.

Investigation of factors influencing the implementation of two shared decision-making interventions in contraceptive care: a qualitative interview study among clinical and administrative staff.

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.

Promoting or Undermining Quality Decision Making? A Qualitative Content Analysis of Patient Decision Aids Comparing Surgical and Medication Abortion.

OBJECTIVES: To understand, describe, and compare the content of patient decision aids on surgical and medication abortion, including 1) attributes used to describe each method, 2) approaches to clarify patients' values, 3) language used to describe each method, and 4) language used to frame women's decision-making role. STUDY DESIGN: We analyzed 49 decision aids identified through a previous systematic review and environmental scan. We used summative content analysis for objectives 1 and 2 and directed content analysis for objectives 3 and 4. RESULTS: We identified 37 method attributes. Overall, the attributes privileged medical over practical and emotional information. One decision aid included an explicit values clarification approach, and others included implicit approaches, which varied in length, information consistency, and organization. We identified four themes-information consistency, subjective claims, emotive or ambiguous descriptions, and medication abortion as not a real abortion-related to the methods' descriptions. We identified three themes-agency in choice, unclear emphasis on women's preferences, and endorsement of clinic services-related to women's decision-making role. Of the nine tools that listed factors influencing women's decision making, patient preferences was often listed last. CONCLUSIONS: Early abortion method decision aids presented a broad range of information and typically framed the method choice as the woman's. However, their emphasis on medical attributes, use of inconsistent information, and, at times, biased presentation of methods may undermine quality decision making. We recommend adapting an existing decision aid or designing a novel tool based on the content and language that women find most acceptable.

Adapting the Interpersonal Quality in Family Planning care scale to assess patient perspectives on abortion care.

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.

Quantity over quality-Findings from a systematic review and environmental scan of patient decision aids on early abortion methods.

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.

Right For Me: protocol for a cluster randomised trial of two interventions for facilitating shared decision-making about contraceptive methods.

INTRODUCTION: Despite 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 ANALYSIS: We 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 DISSEMINATION: We 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 NUMBER: ClinicalTrials.gov Identifier: NCT02759939.

The feasibility and impact of a yoga pilot programme on the quality-of-life of adults with acquired brain injury.

OBJECTIVE: This pilot study measured the feasibility and impact of an 8-week yoga programme on the quality-of-life of adults with acquired brain injury (ABI). METHODS: Thirty-one adults with ABI were allocated to yoga (n = 16) or control (n = 15) groups. Participants completed the Quality of Life After Brain Injury (QOLIBRI) measure pre- and post-intervention; individuals in the yoga group also rated programme satisfaction. Mann-Whitney/Wilcoxon and the Wilcoxon Signed Rank tests were used to evaluate between- and within-group differences for the total and sub-scale QOLIBRI scores, respectively. RESULTS: No significant differences emerged between groups on the QOLIBRI pre- or post-intervention. However, there were significant improvements on overall quality-of-life and on Emotions and Feeling sub-scales for the intervention group only. The overall QOLIBRI score improved from 1.93 (SD = 0.27) to 2.15 (SD = 0.34, p = 0.01). The mean Emotions sub-scale increased from 1.69 (SD = 0.40) to 2.01 (SD = 0.52, p = 0.01), and the mean Feeling sub-scale from 2.1 (SD = 0.34) to 2.42 (SD = 0.39, p = 0.01). CONCLUSION: Adults with ABI experienced improvements in overall quality-of-life following an 8-week yoga programme. Specific improvements in self-perception and negative emotions also emerged. High attendance and satisfaction ratings support the feasibility of this type of intervention for people with brain injury.

Using Option Grids: steps toward shared decision-making for neonatal circumcision.

OBJECTIVES: To assess the impact, acceptability and feasibility of a short encounter tool designed to enhance the process of shared decision-making and parental engagement. METHODS: We analyzed video-recordings of clinical encounters, half undertaken before and half after a brief intervention that trained four clinicians how to use Option Grids, using an observer-based measure of shared decision-making. We also analyzed semi-structured interviews conducted with the clinicians four weeks after their exposure to the intervention. RESULTS: Observer OPTION(5) scores were higher at post-intervention, with a mean of 33.9 (SD=23.5) compared to a mean of 16.1 (SD=7.1) for pre-intervention, a significant difference of 17.8 (95% CI: 2.4, 33.2). Prior to using the intervention, clinicians used a consent document to frame circumcision as a default practice. Encounters with the Option Grid conferred agency to both parents and clinicians, and facilitated shared decision-making. Clinician reported recognizing the tool's positive effect on their communication process. CONCLUSIONS: Tools such as Option Grids have the potential to make it easier for clinicians to achieve shared decision-making. PRACTICE IMPLICATIONS: Encounter tools have the potential to change practice. More research is needed to test their feasibility in routine practice.

Findings from a novel approach to publication guideline revision: user road testing of a draft version of SQUIRE 2.0.

BACKGROUND: The 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. METHODS: Forty-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. RESULTS: Consistent 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. CONCLUSIONS: User 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.

Multistate Collaboration to Confidentially Review Unanticipated Perinatal Outcomes: Lessons Learned.

This commentary describes the development of The Northern New England Perinatal Quality Improvement Network's Confidential Review and Improvement Board and its lessons learned from reviewing cases of unanticipated perinatal outcomes between 2010 and 2013. The Confidential Review and Improvement Board is a multistate mechanism for rigorous and confidential case review of unanticipated perinatal outcomes among unaffiliated academic medical centers, community hospitals, and home birth midwives. We performed semistructured interviews with key individuals participating in the Confidential Review and Improvement Board since its inception and used inductive content analysis to analyze 22 consecutive case reviews. The Confidential Review and Improvement Board's case reviews involved five key clinical situations: second stage of labor management with neonatal depression, obstetric hemorrhage, uterine rupture, fetal demise, and maternal sepsis. A recurrent theme was failure to differentiate maternal from fetal heart rate associated with the birth of severely compromised newborns. Analysis of the Confidential Review and Improvement Board cases revealed opportunities for improvement in the following categories: 1) timely application of best practice, 2) documentation, and 3) communication. The Confidential Review and Improvement Board's evidence-based recommendations centered on strengthening multidisciplinary training through simulation, improving documentation and communication systems, and developing and implementing guidelines with appropriate tools. The Confidential Review and Improvement Board demonstrates that collaboration among unaffiliated rural perinatal providers--who are often direct market competitors--is possible and catalyzes regional improvement efforts.

Medical versus surgical methods of early abortion: protocol for a systematic review and environmental scan of patient decision aids.

INTRODUCTION: Currently, 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 ANALYSIS: For 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 DISSEMINATION: As 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 NUMBER: This protocol is registered in the International Prospective Register of Systematic Reviews (CRD42015016717).

Quality of life of Ethiopian women after fistula repair: implications on rehabilitation and social reintegration policy and programming.

Despite growing recognition of the importance of linking obstetric fistula prevention and treatment strategies with rehabilitation and social reintegration programmes, little research and programming has been oriented toward this goal. Using in-depth interviews, this study aimed to examine the experiences of 51 Ethiopian women after fistula repair surgery to identify priority post-repair interventions that could maximise their quality of life. The results showed that the majority of women felt a dramatic sensation of relief and happiness following repair, yet some continued to experience mental anguish, stigma, and physical problems regardless of the outcome of the procedure. All women suffered intense fear of developing another fistula, most commonly from sex or childbirth. Despite this, the majority of women had sex or planned to do so, while a smaller cohort avoided intercourse and childbearing, thus subjecting them to isolation, marital conflict, and/or economic vulnerability. Our findings suggest that obstetric fistula programmes should integrate (1) post-repair counselling about fistula and risk factors for recurrence, (2) community-based follow-up care, (3) linkages to income-generating opportunities, (4) engagement of women affected by fistula for community outreach, and (5) metrics for evaluating rehabilitation and social reintegration efforts to ensure women regain healthy, productive lives.

What matters most? The content and concordance of patients' and providers' information priorities for contraceptive decision making.

OBJECTIVE(S): The objective of this study was to identify women's and health care providers' information priorities for contraceptive decision making and counseling, respectively. STUDY DESIGN: Cross-sectional surveys were administered online to convenience samples of 417 women and 188 contraceptive care providers residing in the United States. Participants were provided with a list of 34 questions related to the features of contraceptive options and rated the importance of each. Participants also ranked the questions in descending order of importance. For both women and providers, we calculated the mean importance rating for each question and the proportion that ranked each question in their three most important questions. RESULTS: The average importance ratings given by women and providers were similar for 18 questions, but dissimilar for the remaining 16 questions. The question rated most important for women was "How does it work to prevent pregnancy?" whereas, for providers, "How often does a patient need to remember to use it?" and "How is it used?" were rated equally. The eight questions most frequently selected in the top three by women and/or providers were related to the safety of the method, mechanism of action, mode of use, side effects, typical- and perfect-use effectiveness, frequency of administration and when it begins to prevent pregnancy. CONCLUSION(S): Although we found considerable concordance between women's and provider's information priorities, the presence of some inconsistencies highlights the importance of patient-centered contraceptive counseling and, in particular, shared contraceptive decision making. IMPLICATIONS: This study provides insights into the information priorities of women for their contraceptive decision making and health care providers for contraceptive counseling. These insights are critical both to inform the development of decision support tools for implementation in contraceptive care and to guide the delivery of patient-centered care.