Using Patient Feedback to Optimize the Design of a Certolizumab Pegol Electromechanical Self-Injection Device: Insights from Human Factors Studies

Introduction

We incorporated patient feedback from human factors studies (HFS) in the patient-centric design and validation of ava^®, an electromechanical device (e-Device) for self-injecting the anti-tumor necrosis factor certolizumab pegol (CZP).

Methods

Healthcare professionals, caregivers, healthy volunteers, and patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or Crohn’s disease participated in 11 formative HFS to optimize the e-Device design through intended user feedback; nine studies involved simulated injections. Formative participant questionnaire feedback was collected following e-Device prototype handling. Validation HFS (one EU study and one US study) assessed the safe and effective setup and use of the e-Device using 22 predefined critical tasks. Task outcomes were categorized as “failures” if participants did not succeed within three attempts.

Results

Two hundred eighty-three participants entered formative (163) and validation (120) HFS; 260 participants performed one or more simulated e-Device self-injections. Design changes following formative HFS included alterations to buttons and the graphical user interface screen. All validation HFS participants completed critical tasks necessary for CZP dose delivery, with minimal critical task failures (12 of 572 critical tasks, 2.1%, in the EU study, and 2 of 5310 critical tasks, less than 0.1%, in the US study).

Conclusion

CZP e-Device development was guided by intended user feedback through HFS, ensuring the final design addressed patients’ needs. In both validation studies, participants successfully performed all critical tasks, demonstrating safe and effective e-Device self-injections.

Funding

UCB Pharma.

Plain Language Summary

Plain language summary available on the journal website.

     

Does Familial Mediterranean Fever Provoke Atherosclerosis in Children? Evaluation of Arterial Stiffness and Serum Endocan Levels

Clinical Rheumatology - This study aimed to evaluate the risk for atherosclerosis by using echocardiographic arterial stiffness (AS) parameters and serum endocan levels, as a biomarker of...     

Protein oxidation in Type 2 diabetic patients on hemodialysis

BACKGROUND: Oxidative stress is considered to be a unifying link between diabetes mellitus (DM) and its complications, including nephropathy. There have been many reports on increased production of oxidants and decreased level of antioxidants in diabetic patients. The dialysis procedure contributes to oxidative stress. An increase in oxidative stress may contribute to the development of oxidative protein damage in diabetic patients. Our aim was to reveal the effects of diabetes and hemodialysis (HD) on oxidative modifications of plasma proteins. METHODS: We measured reactive carbonyl derivates (PCO), protein thiol (P-SH), and reduced glutathione (GSH) levels in Type 2 diabetic (DM) and diabetic hemodialysed patients (DHD) and in healthy control participants. RESULTS: Protein carbonyl (PCO) content increased significantly in all patient groups relative to the controls. The dialysis procedure caused an additional increase in PCO levels in DHD patients before and after dialysis compared with the level in DM patients. There was a significant decrease in P-SH levels in DHD patients compared with the level in healthy participants and DM patients. There was no significant difference in the whole blood GSH levels between the DM patients and control participants. It was significantly higher in DHD patients in comparison to the DM patients. CONCLUSIONS: We conclude that PCO level increases in DM patients, and this increase is more profound in DHD patients, indicating that both diabetes and dialysis contribute to increased protein oxidation. The low P-SH level in DHD patients, but not in DM patients, suggests that dialysis is responsible for this decrease. We propose plasma PCO derivate as a novel specific marker for oxidative protein damage.     

A case of rhabdomyolysis and thromboembolic event secondary to fibrate monotherapy

Fibrates either alone or in combination with statins have been commonly used for the treatment of high non-HDL-cholesterol levels. In addition, this type of therapy is also associated with some adverse events like rhabdomyolysis. We present the first case in the literature describing the development of both rhabdomyolysis-induced acute renal failure and thromboembolic event under the treatment of fibrate monotherapy.     

Impact of various ecological parameters on the life-history characteristics of Bufotes viridis sitibundus from Turkey

In this study, we used the skeletochronology method to estimate various growth parameters, such as age structure, minimum and maximum life span, age of sexual maturity, and the relationship between body size and weight of eight different populations of the variable toad, Bufotes viridis sitibundus, in Turkey. Further, we determined the relationship between these parameters and ecologic factors using the partial Mantel test. A significant difference was found among the populations with respect to age, body size, and body weight in both males and females. On average, the maximum life span was recorded as 10 years for males and 11 years for females. In the studied populations, the average age of sexual maturity ranged between 2 and 4 years for both sexes. Sexual dimorphism in terms of snout-vent length (SVL) was not observed between males and females in all the populations. Toads from the higher altitudes tended to be significantly larger, older, and heavier than those from lower altitudes. We concluded that altitude and temperature have an impact on the growth rate, body size, and body mass.     

Prognostic significance of 68Ga-Pentixafor PET/CT in multiple myeloma recurrence: a comparison to 18F-FDG PET/CT and laboratory results

Annals of Nuclear Medicine - This study investigates the prognostic value of 68Ga-Pentixafor PET/CT using PET-derived quantitative in multiple myeloma (MM) patients with suspected recurrence in...     

Effects of denture cleaning solutions on the retention of Hader bar clips

Statement of problemThe clinical performance of implant-retained overdentures (IODs) with plastic bar clips made of different materials in the same design and dimensions may vary according to the patient’s daily home care procedures. However, information about the effects of denture cleaning solutions on the retention of Hader bar clips is lacking.PurposeThe purpose of this in vitro study was to evaluate the retention of Hader bar clips made of different polymers after being soaked in denture cleaning solutions.Material and methodsNinety Hader bar clips made of polyamide (PA, n=30), polytetrafluoroethylene (PTFE, n=30), and polyetherketoneketone (PEKK, n=30) materials were tested. Two multiunit abutments were screwed onto the implant analogs and embedded into an acrylic resin block in a standardized position. The digital scanning of the abutments was acquired, and the bar patrix of each material system milled from a cobalt-chromium (Co-Cr) alloy disk by using computer-aided design and computer-aided manufacturing (CAD-CAM). After the milled bar patrices were screwed onto abutments and the metal housings of the bar clips were embedded into acrylic resin blocks, they were connected passively at the same angulation to a universal testing machine. The initial retention values of all Hader bar clips were measured, and each material system was divided into 3 subgroups (n=10) before soaking in the cleaning solutions: distilled water (DW), 5% sodium hypochlorite (NaOCl), or sodium bicarbonate-sodium perborate (SBSP). Each material was soaked for the equivalent of 3 months of clinical use. The final retention values of each Hader bar clip were measured. The data were statistically analyzed by using a 2-way analysis of variance (ANOVA), the Tukey honestly significant difference (HSD) test, and the paired sample t test (α=.05).ResultsThe 2-way ANOVA showed that the denture cleaning solution, the clip material, and their interactions led to significantly different retention values (P<.001). A decrease was observed for the retention values of all test groups after soaking in the cleaning solutions (P<.05). No retention was observed for the PTFE clips after soaking in the 5% NaOCI solution.ConclusionsThe denture cleaning solutions negatively affected the retention of Hader bar clips, regardless of the type of solution and clip material. The 5% NaOCI solution not only decreased the retention of PTFE clips but also completely degraded it. It is recommended that 5% NaOCI solution be avoided for the daily care of IODs with PTFE clips.