Trial design of comparing patient-specific versus weight-based protocols to treat vaso-occlusive episodes in sickle cell disease (COMPARE-VOE).

OBJECTIVES: Painful vaso-occlusive episodes (VOE) are the most common reason for emergency department (ED) visits experienced by patients with sickle cell disease (SCD). The National Heart, Lung and Blood Institute (NHLBI) evidence-based recommendations for VOE treatment are based primarily on expert opinion. In this randomized controlled trial (RCT), we will compare changes in pain scores between patients randomized to a patient-specific analgesic protocol versus those randomized to a weight-based analgesic protocol, as recommended by the NHLBI guidelines. METHODS: We report the rationale and design of a multi-site, phase III, single-blinded, RCT to be conducted in six EDs in the United States. Eligible participants will be randomized after providing consent, anticipating 50% of those randomized would have an ED visit during the enrollment period. A total of 230 participants with one VOE ED visit provides sufficient power to detect a clinically significant difference in pain score reductions of 14 between groups with 0.05 type I error. Uniquely, this trial randomizes participants in a larger population than the study population, given the impossibility of consenting and randomizing participants during emergencies. The primary endpoint is the change in pain scores in the ED from time of placement in treatment area to time of disposition (hospitalization, discharged home, or assigned to observation status) or a maximum treatment duration of 6 hours. Additional outcomes include hospitalizations and ED visits seven days post enrollment, side effects, and safety assessments. CONCLUSIONS: The COMPARE-VOE study design will provide high-level evidence to support the NHLBI VOE treatment guidelines.

The experiences of seven women living with pelvic surgical mesh complications.

INTRODUCTION: This research sought to address a gap in the literature about women's lived experience of pelvic surgical mesh complications, conducted by an insider researcher. An increasing number of women who have pelvic mesh surgeries with a view to improving their lives are experiencing life-altering complications. Without knowledge of these experiences we cannot know how best to care for affected women and prevent harm to further women. METHODS: Van Manen's hermeneutic phenomenological method was used. Seven women with pelvic mesh complications aged 43-69 years were enrolled using criterion sampling. Four of the seven women had surgical mesh for both pelvic organ prolapse (POP) and stress urinary incontinence (SUI), one for POP only, and two for SUI only. The women completed a modified ICIQ-LUTSqol questionnaire pre-interview and answered a separate global spiritual question adapted from the HOPE tool, a framework for spiritual assessment. Women were interviewed once using a semi-structured approach. Data were analysed using Van Manen's selective reading technique and organized according to Lifeworld Existentials. RESULTS: Modified ICIQ-LUTSqol scores ranged between 43 and 76 (range 19-76), with a mean of 62.2 (SD + 10.011) demonstrating significant impact on quality of life. Themes emerging from the analysis were: (1) lived space: 1(a) feeling powerless in the medical space, 1(b) living in a shrinking world; (2) lived body: 2(a) living with unrelenting pain, 2(b) inhabiting a body that can no longer be relied on; (3) lived time: 3(a) living in the gap between what was and what could have been; (4) lived other: 4(a) suffering in silence, 4(b) finding absolute Other and others as a source of strength. CONCLUSIONS: Pelvic surgical mesh complications have an extensive adverse impact on the lifeworld of women experiencing complications. Failure to acknowledge mesh complications as treatment injury stalls the development of safer alternatives and changes needed to industry practices, regulation, clinical practice, and monitoring to keep women undergoing innovative urogynaecological procedures safe.