OBJECTIVE: The aim of the study was to describe the characteristics and outcomes of GPP flares using historical medical information from patients enrolled in the Effisayil™ 1 trial.
METHODS: Investigators collected retrospective medical data characterizing patients' GPP flares prior to clinical trial enrollment. Data on overall historical flares were collected, as well as information on patients' typical, most severe, and longest past flares. This included data on systemic symptoms, flare duration, treatment, hospitalization, and time to clearance of skin lesions.
RESULTS: In this cohort (N = 53), patients with GPP experienced a mean of 3.4 flares per year. Flares were painful, associated with systemic symptoms, and often triggered by stress, infections, or treatment withdrawal. Resolution of flares was longer than 3 weeks in 57.1%, 71.0%, and 85.7% of documented (or identified) typical, most severe, and longest flares, respectively. GPP flares led to patient hospitalization in 35.1%, 74.2%, and 64.3% of patients for their typical, most severe, and longest flares, respectively. For the majority of patients, pustules took up to 2 weeks to clear for a typical flare and 3-8 weeks to clear for the most severe and longest flares.
CONCLUSION: Our findings highlight that current treatment options are slow to control GPP flares and provide context for assessing the efficacy of new therapeutic strategies in patients with a GPP flare.
METHODS: The candidate vaccines' pharmaceutical parameters (e.g. platforms, number needed to vaccinate and intervals, adjuvanted status, excipients and preservatives added, efficacy and effectiveness, vaccine adverse events, and boosters), and clinical aspects must be analysed for the mix-and-match approach. Results prime-boost trials showed safety, effectiveness, higher systemic reactogenicity, well tolerability with improved immunogenicity, and flexibility profiles for future vaccinations, especially during acute and global shortages, compared to the homologous counterparts.
CONCLUSION: Still, large controlled trials are warranted to address challenging variants of concerns including Omicron and other, and to generalize the effectiveness of the approach in regular as well as emergency use during vaccine scarcity.
EVIDENCE ACQUISITION: Searches were conducted with the Web of Science, Google Scholar, IEEE Xplore, and PubMed databases from inception up to September 2020. Articles that employed virtual reality in the rehabilitation of individual with upper limb loss were included in the research if it is written in English, the keyword exists in the title and abstract; it uses visual feedback in nonimmersive, semi-immersive, or fully immersive virtual environments. Data extraction was carried out by two independent researchers. The study was drafted using the Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols (PRISMA).
EVIDENCE SYNTHESIS: A total of 38 articles met the inclusion criteria. Most studies were published between 2010 and 2020. Thirty-nine percent of the studies (N.=15), originates from North America; 55% of the studies (N.=21), were publicly funded; 61% of the studies (N.=24), was without disclosure of conflict of interest; 82% of the studies (N.=31), were cited in other studies. All the studies were published in journals and conference proceedings. Sixty-six percent of the studies (N.=25) has come out with positive outcome. The design studies were mostly case reports, case series, and poorly designed cohort studies that made up 55% (N.=21) of all the studies cited here.
CONCLUSIONS: The research conducted on the use of virtual reality in individual with upper limb loss rehabilitation is of very low quality. The improvements to the research protocol are much needed. It is not necessary to develop new devices, but rather to assess existing devices with well-conducted randomized controlled trials.