Comparison of electrocardiogram quality and clinical interpretations using prepositioned ECG electrodes and conventional individual electrodes.

BACKGROUND: Efforts have been made to simplify and reduce technical errors, such as limb leads reversal and inaccurate chest leads placement, for the 12-lead ECG tests. We compared standard ECG using individual electrodes with a novel pre-positioned electrode system to determine equivalency. METHODS: Subjects were recruited from the Emergency Department and cardiac lab of an acute care hospital in Los Angeles. First, subjects underwent a conventional 12-lead ECG using Philips PageWriter (clinical ECG). A second ECG was then performed using a novel system containing pre-positioned electrodes and a compact recorder (study ECG). All ECGs were reviewed by 3 blinded, board-certified adult cardiologists using 14 pre-specified ECG diagnostic categories to determine if the interpretations of clinical ECG and study ECG of the same patient were "equivalent". Majority rule was applied when there were discrepant interpretations among the 3 cardiologists. RESULTS: One hundred subjects, ages 18 to 74 completed the study. With pre-positioned electrodes, the rate of "electrode fit" as judged by the research associates at the time of lead placement was 96.2%. We found that the study ECG system was equivalent (in clinical interpretation) to the clinical ECG system, with equivalency rate of 96% (95% confidence interval 92% to 100%) in "overall interpretation". The equivalence rate for the 14 ECG diagnostic categories ranged from 96% to 100%, with mean 99.2 ± 1.1%. CONCLUSIONS: 12-lead ECGs performed using single-piece, pre-positioned electrodes are clinically equivalent to those performed using 10 individually placed conventional electrodes. With 4 sizes for adults, the single-piece electrodes can fit 96% of the study patients.

Home use of a compact, 12­lead ECG recording system for newborns.

BACKGROUND: An easy-to-operate ECG recorder should be useful for newborn screening for heart conditions, by health care workers - or parents. We developed a one-piece electrode strip and a compact, 12­lead ECG recorder for newborns. METHOD: We enrolled 2582 newborns in a trial to assess abilities of parents to record a 12­lead ECG on their infants (2-4 weeks-old). Newborns were randomized to recordings by parents (1290) or our staff (1292 controls). Educational backgrounds of parents varied, including 64% with no more than a high school diploma. RESULTS: For newborns randomized to parent recorded ECGs, 94% of parents completed a 10-minute recording. However, 42.6% asked for verbal help, and 12.7% needed physical help. ECG quality was the same for recordings by parents versus staff. CONCLUSIONS: By use of a one-piece electrode strip and a compact recorder, 87% of parents recorded diagnostic quality ECGs on their newborn infants, with minimal assistance.

Patient-Reported Outcomes in Autosomal Dominant Osteopetrosis: Findings from the Osteopetrosis Registry Study.

CONTEXT: Autosomal dominant osteopetrosis (ADO) is a rare sclerotic bone disease characterized by impaired osteoclast activity, resulting in high bone mineral density and skeletal fragility. The full phenotype and disease burden on patients' daily lives has not been systematically measured. OBJECTIVE: We developed an online registry to ascertain population-based data on the spectrum and rate of progression of disease and to identify relevant patient centered outcomes that could be used to measure treatment effects and guide the design of future clinical trials. DESIGN: Cross-sectional data from participants with osteopetrosis were collected using an online REDCap-based database. PARTICIPANTS: Thirty-four participants with a confirmed diagnosis of ADO, aged 4-84 years. MAIN OUTCOME MEASURES: Participants aged 18 years and older completed the PROMIS 57, participants aged 8 to 17 years completed the PROMIS Pediatric 49, and parents of participants aged <18 years completed the PROMIS Parent Proxy 49. RESULTS: Based on the PROMIS 57, relative to the general population, adults with ADO reported low physical function and low ability to participate in social roles and activities, and high levels of anxiety, fatigue, sleep problems, and pain interference. Daily pain medications were reported by 24% of the adult population. In contrast, neither pediatric participants, nor their parent proxy reported a negative impact on health-related quality of life. CONCLUSIONS: Data from this registry demonstrate the broad spectrum of ADO disease severity and high impact on health-related quality of life in adults with ADO.