Women- and clinician- important outcomes and priorities regarding vasa praevia: An international qualitative study to inform development of a core outcome set.

BACKGROUND: Many studies have reported interventions for women with vasa praevia to improve perinatal outcomes. However, which outcomes are important for women remains unclear. AIM: To explore what outcomes are important for women with lived experience of vasa praevia and why, in order to inform the development of a core outcome set for studies on vasa praevia. METHODS: An international qualitative study was conducted with women and clinicians. Semi-structured interviews were audio-recorded, transcribed, and analysed taking an inductive approach. FINDINGS: Eighteen women and six clinicians (four obstetricians, two midwives) from the United States, United Kingdom, Canada, and Australia were interviewed. Participants identified 47 patient-important outcomes and experience measures, which were grouped under five themes: baby's survival and health, mother's physical health, mother's mental and emotional health, quality of health care delivery, and resource use and cost. While survival of the baby without short- and long-term morbidity remained the main priority, other important considerations included the physical, mental, social and financial wellbeing of families, future access to antenatal screening and diagnosis, information on management options and consequences, continuity of care, clear and effective communication, peer support and the appreciation of individual variations to risk tolerance, values and resource availability. CONCLUSION: We have identified patient-important outcomes and experience measures that have been directly fed into the development of a core outcome set on vasa previa. Incorporating these considerations into both clinical practice and future research studies has the potential to improve outcomes and experiences for women with vasa praevia.

Obesity in Pregnancy - Patient-Reported Outcomes in Qualitative Research: A Systematic Review.

The purpose of this study was to determine the clinical and non-clinical outcomes that pregnant women with obesity value as pertaining to their health and that of their babies. In this systematic review of the qualitative literature, a search of four databases was conducted for studies using qualitative methods in pregnant women with obesity. From the included studies, the review synthesized relevant themes representing the voiced concerns and perceived benefits of and barriers to the uptake of interventions, to yield patient-reported outcomes (PROs). PROs were categorized into domains according to the published taxonomy of outcomes in medical research. Of the 89 identified studies, 27 were included, none of which were primarily intended to elicit PROs. A total of 256 PROs and 7 distinct themes were identified. Only 13% of PROs represented physiological or clinical outcomes, whereas 21% represented the core area of emotional functioning or well-being, and 15% represented the area of delivery of care. The most frequently voiced concern was inadequate health care provider support (60%), and women considered intervention-specific challenges to be the greatest barriers to the uptake of interventions (34%). This study synthesized the qualitative evidence of concerns that pregnant women with obesity have regarding their pregnancy and postpartum care, as well as specific barriers they perceive to the uptake of interventions. In addition, this study revealed that clinical outcomes, which are most often reported in clinical trials, comprise only a minority of outcomes considered important by these women. A core outcome set that adequately incorporates PROs is required to inform the conduct of future trials in pregnant women with obesity.

Variation in outcome reporting in studies on obesity in pregnancy-A systematic review.

Although considerable research is being conducted with a view to improve outcomes for pregnant women with obesity and their babies, much of this research is compromised by the quality of outcome reporting. Our aim is to determine how outcomes have been reported and measured in obesity in pregnancy studies, as a first step towards developing a core outcome set to standardize outcome reporting in future trials. We conducted a systematic review of clinical trials and systematic reviews on obesity in pregnancy in accordance with the Preferred Reporting in Systematic Reviews and Meta-analyses guidelines. We searched Medline, Embase, controlled register of trials, World Health Organization International Clinical Trials Registry, www.clinicaltrials.gov and Google Scholar, for relevant studies and extracted study characteristics, outcome reporting and measurement. Reporting quality was assessed using previously published criteria. Outcomes were grouped using a published taxonomy and variations in outcome reporting and measurement were descriptively presented. Seventy included studies yielded a total of 135 outcomes. Foetal/neonatal outcomes were not reported in 53.3% of studies where an intervention could have implications to both, mother and baby. Reported outcomes were mostly physiological/clinical (74.8%), with very limited representation of outcomes related to mortality/survival (5.2%), life impact (7.4%), adverse events (5.9%) and resource utilization (6.7%).

Can a Partially Injured Donor Nerve Restore Elbow Flexion in an Acute Brachial Plexus Injury in Rats?

BACKGROUND: Loss of elbow flexion commonly occurs following acute brachial plexus injury. The double fascicular transfer is often used in acute C5-C6 and C5-C7 root injuries, but is rarely applied in cases involving concomitant C8 or T1 root injury. The authors designed a rat model using varying severities of lower trunk injury to determine whether partial injury to the lower trunk affects nerve transfers for elbow flexion. METHODS: There were four different rat groups in which 0, 25, 75, or 100 percent of the donor lower trunk remained intact. One-fourth of the cross-sectional area of the ulnar nerve was then transferred to the musculocutaneous nerve immediately. The authors assessed outcomes using a grooming test, muscle mass, retrograde labeling of sensory/motor neurons that regenerated axons, and immunohistochemical stain of regenerated axons. RESULTS: Five months after nerve transfer, rats that underwent partial injury of the lower trunk fared significantly worse than the rats in whom the donor lower trunk remained 100 percent intact, but significantly better than the rats with 0 percent intact lower trunk. Rats with 25 or 75 percent of the lower trunk intact recovered equivalent function, at both the donor and recipient sites. CONCLUSIONS: Although relatively weak compared with the 100 percent intact donor lower trunk group, the partially injured donor nerve was still functional; even though the nerve sustained a partial injury, the residual axons reinnervated the target muscles. The power of the muscles following either 25 percent or 75 percent injuries was equal after the recovery. Resorting to this approach may be useful in cases in which no alternatives are available.

Development of a Core Outcome Set for Studies on Obesity in Pregnant Patients (COSSOPP): a study protocol.

BACKGROUND: Maternal obesity is a risk factor for adverse maternal, fetal, and neonatal events. Numerous clinical trials are currently exploring the effectiveness of antenatal and peripartum interventions in improving pregnancy outcomes that can in future inform clinical practice. However, the heterogeneity in outcome reporting limits our ability to compare outcomes across studies, and there is a lack of stakeholder representation in outcome choice. A pragmatic solution to this problem is the development of a core outcome set (COS) that defines the minimum criteria for outcome reporting in clinical trials undertaken in this population, arrived at by the involvement of relevant stakeholders. METHODS: The development of a COS for studies on obesity in pregnant patients (COSSOPP) will comprise five steps. First, a systematic review of published literature will identify the long list of outcomes, their definitions and measurements if applicable, and outcome reporting quality. This will be followed by a meta-synthesis of qualitative studies with patients, and qualitative interviews in Toronto with patients, clinicians, researchers, hospital administrators, and policy-makers, to identify novel outcomes that were not obtained through systematic review. Third, the long list of outcomes will be narrowed down through online Delphi surveys involving an international group of patients and relevant stakeholders. This will be followed by a face-to-face consensus meeting with representatives of all stakeholder groups to arrive at a consensus on the final COS. Finally, in order to determine how the identified core outcomes should be measured, we will conduct another literature review and Delphi process. DISCUSSION: COSSOPP will engage patients, clinicians, researchers, and other relevant stakeholders in determining the core set of outcomes that should be reported and measured in order to harmonize outcome reporting in studies evaluating the effectiveness of antepartum and peripartum interventions in obese pregnant women. This protocol provides a detailed overview of the steps involved in the development of a COS, to guide researchers in developing COS within their areas of specialization. COMET CORE OUTCOME SET REGISTRATION: http://www.comet-initiative.org/studies/details/939 .