RESUMO
Despite human saliva representing a convenient and non-invasive clinical substrate for disease diagnosis and biomonitoring, its widespread utilization has been hampered by technical challenges. The non-Newtonian, heterogenous and highly viscous nature of clinical saliva samples complicate the development of automated fluid handling processes that are vital for accurate diagnoses. Furthermore, conventional saliva processing methods are either resource and/or time intensive precluding certain testing capabilities in low- and middle-income countries, with these challenges aggravated during a pandemic outbreak. The conventional approaches can also potentially alter analyte structure, reducing application opportunities in Point-of-Care diagnostics. To overcome these challenges, we introduce the SHEAR saliva collection device that preprocesses saliva for enhanced interfacing with downstream assays. We demonstrate the devices impact on reducing salivas viscosity, improving sample uniformity and, increasing diagnostic performance of COVID-19 Rapid Antigen Tests. Importantly, in addition to reporting technical advances and to address downstream implementation factors, we conducted a formal user experience study, which resulted in generally positive comments. Effective implementation of this device could be of support to realize the potential of saliva, particularly in large-scale and/or resource-limited settings for global and community health diagnostics.
RESUMO
Background/Aims@#Constipation can be a chronic condition that impacts daily functioning and quality of life (QoL). To aid healthcare providers in accurately assessing patient symptoms and treatment outcomes, patient-related outcome measures (PROMs) have been increasingly adopted in clinical settings. This review aims to (1) evaluate the methodological quality and measurement properties of constipationrelated PROMs, using the COnsensus-based Standards for the selection of health Measurement INtruments (COSMIN) criteria; and (2) assess the modes of digital dissemination of constipation-related PROMs. @*Methods@#PubMed, Embase, and PsycINFO databases were searched and 11 011 records ranging from 1989 to 2020 were screened by 2 independent reviewers. A total of 26 studies (23 PROMs; 18 measuring symptom-related items and 5 measuring constipation-related QoL items) were identified for the review and assessed. @*Results@#There were multiple variations between PROMs, including subtypes of constipation, methods of administration, length of PROM and recall period. While no PROM met all the COSMIN quality standards for development and measurement properties, 5 constipationrelated PROMs received at least 4 (out of 7) sufficient ratings. Only 2 PROMs were developed in Asia. Five PROMs were administered through digital methods during the validation process but methods of adapting the PROMs into digital formats were not reported. @*Conclusions@#The constipation-related PROMs identified in this review present varying quality of development and validation, with an overall need for improvement. Further considerations should be given towards more consistent methodology and reporting of PROM development, increase in culturally-specific PROMs, and better reporting of protocol for the digitization of PROMs.
