BackgroundAccurately monitoring adherence to treatment with recombinant human growth hormone (r-hGH) enables appropriate intervention in cases of poor adherence. The electronic r-hGH auto-injector, easypod™, automatically records the patient's adherence to treatment. This study evaluated adherence to treatment of children who started using the auto-injector and assessed opinions about the device.MethodsA multicentre, multinational, observational 3-month survey in which children received r-hGH as part of their normal care. Physicians reviewed the recorded dose history and children (with or without parental assistance) completed a questionnaire-based survey. Children missing ≤2 injections per month (92% of injections given) were considered adherent to treatment. Adherence was compared between GH treatment-naïve and treatment-experienced children.ResultsOf 834 recruited participants, 824 were evaluated. The median (range) age was 11 (1-18) years. From the recorded dose history, 87.5% of children were adherent to treatment over the 3-month period. Recorded adherence was higher in treatment-naïve (89.7%, n = 445/496) than in treatment-experienced children (81.7%, n = 152/186) [Fisher's exact test FI(X) = 7.577; p = 0.0062]. According to self-reported data, 90.2% (607/673) of children were adherent over 3 months; 51.5% (421/817) missed ≥1 injection over this period (mainly due to forgetfulness). Concordance between reported and recorded adherence was 84.3%, with a trend towards self-reported adherence being higher than recorded adherence. Most children liked the auto-injector: over 80% gave the top two responses from five options for ease of use (720/779), speed (684/805) and comfort (716/804). Although 38.5% (300/780) of children reported pain on injection, over half of children (210/363) considered the pain to be less or much less than expected. Given the choice, 91.8% (732/797) of children/parents would continue using the device.Conclusionseasypod™ provides an accurate method of monitoring adherence to treatment with r-hGH. In children who received treatment with r-hGH using easypod™, short-term adherence is good, and significantly higher in treatment-naïve children compared with experienced children. Children/parents rate the device highly. The high level of acceptability of the device is reflected by a desire to continue using it by over 90% of the children in the survey.
Individual responses to growth hormone (GH) treatment are variable. Short-term generation of insulin-like growth factor-I (IGF-I) is recognized as a potential marker of sensitivity to GH treatment. This prospective, phase IV study used an integrated genomic analysis to identify markers associated with 1-month change in IGF-I (ΔIGF-I) following initiation of recombinant human (r-h)GH therapy in treatment-naïve children with GH deficiency (GHD) (n=166) or Turner syndrome (TS) (n=147). In both GHD and TS, polymorphisms in the cell-cycle regulator CDK4 were associated with 1-month ΔIGF-I (P<0.05). Baseline gene expression was also correlated with 1-month ΔIGF-I in both GHD and TS (r=0.3; P<0.01). In patients with low IGF-I responses, carriage of specific CDK4 alleles was associated with MAPK and glucocorticoid receptor signaling in GHD, and with p53 and Wnt signaling pathways in TS. Understanding the relationship between genomic markers and early changes in IGF-I may allow development of strategies to rapidly individualize r-hGH dose.
Purpose: This study compared real-world safety and efficacy outcomes of cataract surgery performed with LenSx femtosecond laser-assisted cataract surgery or manual phacoemulsification cataract surgery procedures. Methods: A retrospective observational study used data from anonymised electronic medical records to compare mean cumulative dissipated energy, the proportion of eyes reaching emmetropia, mean change in best-corrected distance visual acuity and the proportion of eyes with post-surgical complications, including corneal oedema and posterior capsule opacification. Results were adjusted for multiple comparisons for primary and secondary objectives. Results: Data from 811 phacoemulsification cataract surgery and 496 femtosecond laser-assisted cataract surgery procedures were analysed. Mean cumulative dissipated energy was significantly lower for femtosecond laser-assisted cataract surgery (6.5 percent-seconds) than for phacoemulsification cataract surgery (14.3 percent-seconds; p < 0.0001) procedures. More femtosecond laser-assisted cataract surgery (81.2%) procedures achieved emmetropia (⩽ 0.5 dioptre) than did phacoemulsification cataract surgery (73.5%) procedures, although this difference was not statistically significant. Mean change in best-corrected distance visual acuity and the proportion of eyes with corneal oedema, posterior capsule opacification or other complications were not significantly different between cohorts when adjusted for multiple comparisons. Conclusions: In this single-centre, single-surgeon retrospective electronic medical record database study using divide and conquer technique, femtosecond laser-assisted cataract surgery was associated with significantly lower cumulative dissipated energy when compared to manual phacoemulsification cataract surgery. This supports the hypothesis that femtosecond laser-assisted cataract surgery involves less mechanical trauma, which might lead to more consistent refractive and safety outcomes than manual phacoemulsification cataract surgery, though such outcomes were found to be comparable in this study.
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