A Core Outcome Measurement Set for Pediatric Critical Care.

OBJECTIVES: To identify a PICU Core Outcome Measurement Set (PICU COMS), a set of measures that can be used to evaluate the PICU Core Outcome Set (PICU COS) domains in PICU patients and their families. DESIGN: A modified Delphi consensus process. SETTING: Four webinars attended by PICU physicians and nurses, pediatric surgeons, rehabilitation physicians, and scientists with expertise in PICU clinical care or research ( n = 35). Attendees were from eight countries and convened from the Pediatric Acute Lung Injury and Sepsis Investigators Pediatric Outcomes STudies after PICU Investigators and the Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network PICU COS Investigators. SUBJECTS: Measures to assess outcome domains of the PICU COS are as follows: cognitive, emotional, overall (including health-related quality of life), physical, and family health. Measures evaluating social health were also considered. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Measures were classified as general or additional based on generalizability across PICU populations, feasibility, and relevance to specific COS domains. Measures with high consensus, defined as 80% agreement for inclusion, were selected for the PICU COMS. Among 140 candidate measures, 24 were delineated as general (broadly applicable) and, of these, 10 achieved consensus for inclusion in the COMS (7 patient-oriented and 3 family-oriented). Six of the seven patient measures were applicable to the broadest range of patients, diagnoses, and developmental abilities. All were validated in pediatric populations and have normative pediatric data. Twenty additional measures focusing on specific populations or in-depth evaluation of a COS subdomain also met consensus for inclusion as COMS additional measures. CONCLUSIONS: The PICU COMS delineates measures to evaluate domains in the PICU COS and facilitates comparability across future research studies to characterize PICU survivorship and enable interventional studies to target long-term outcomes after critical illness.

A Core Outcome Set for Pediatric Critical Care.

OBJECTIVES: More children are surviving critical illness but are at risk of residual or new health conditions. An evidence-informed and stakeholder-recommended core outcome set is lacking for pediatric critical care outcomes. Our objective was to create a multinational, multistakeholder-recommended pediatric critical care core outcome set for inclusion in clinical and research programs. DESIGN: A two-round modified Delphi electronic survey was conducted with 333 invited research, clinical, and family/advocate stakeholders. Stakeholders completing the first round were invited to participate in the second. Outcomes scoring greater than 69% "critical" and less than 15% "not important" advanced to round 2 with write-in outcomes considered. The Steering Committee held a virtual consensus conference to determine the final components. SETTING: Multinational survey. PATIENTS: Stakeholder participants from six continents representing clinicians, researchers, and family/advocates. MEASUREMENTS AND MAIN RESULTS: Overall response rates were 75% and 82% for each round. Participants voted on seven Global Domains and 45 Specific Outcomes in round 1, and six Global Domains and 30 Specific Outcomes in round 2. Using overall (three stakeholder groups combined) results, consensus was defined as outcomes scoring greater than 90% "critical" and less than 15% "not important" and were included in the final PICU core outcome set: four Global Domains (Cognitive, Emotional, Physical, and Overall Health) and four Specific Outcomes (Child Health-Related Quality of Life, Pain, Survival, and Communication). Families (n = 21) suggested additional critically important outcomes that did not meet consensus, which were included in the PICU core outcome set-extended. CONCLUSIONS: The PICU core outcome set and PICU core outcome set-extended are multistakeholder-recommended resources for clinical and research programs that seek to improve outcomes for children with critical illness and their families.

Serum titanium levels in individuals undergoing intramedullary femoral nailing with a titanium implant.

BACKGROUND: Many patients request nail extraction or question the long-term effects of hardware retention. Systemic titanium degradation products may influence the timing of such decisions. The orthopedic literature provides no data regarding systemic titanium in patients undergoing intramedullary nail fixation with titanium implants. The purpose of this study was to determine the systemic level of serum titanium in patients who had undergone femoral nailing. METHODS: Patients who underwent antegrade locked femoral nailing utilizing a reamed technique with a titanium implant were eligible to participate. Eight patients were recruited for each of four time points: 6 weeks, 3 months, 6 months, and 1 year. Blood samples were collected from each subject. Serum titanium levels were analyzed through inductively coupled plasma/mass spectrometry (ELAN DRC II, Perkin Elmer, SCIEX, Inc, Shelton, CT). Test sensitivity was 0.2 microg/L. Normal serum titanium levels are <150 microg/L. RESULTS: Thirty-two patients were enrolled. The study group included 10 women and 22 men with average age of 32 (range 19-63) years. The most common fracture pattern was 32-A3 (n = 12), followed by 32-B2 (n = 9). No patients showed an elevated serum titanium level. Mean titanium levels were 49.38, 58.25, 49.38, and 50.63 microg/L at 6 weeks, 3 months, 6 months, and 12 months cohorts, respectively. No statistically significant differences were found (p = 0.207). CONCLUSIONS: Standard intramedullary nail fixation of femur fractures did not result in elevated levels of serum titanium in the first year after surgery. Differences in serum titanium did not differ significantly across time since implantation.