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An early dialogue (ED) is non-binding scientific advice given to industry in the initial stages of technology development to help create evidence that the health technology assessment (HTA) agency will request. ED could also be used in the academic ecosystem. We report our experience with the clinical validation of an algorithm to predict persistent remission in patients with rheumatoid arthritis treated with biological therapy.
Methods
A systematic review (SR) was undertaken to compare optimization algorithms with current clinical management. The review focused on the effectiveness and safety of these tools and included clinical practice guidelines, SRs, and primary studies. Several meetings took place between the research team and HTA researchers to integrate HTA requirements (e.g., choice of comparators, relevant outcomes, quality of life, and patient groups) into the study design to ensure the quality and accuracy assurance of data collected as well as the proper monitoring of good clinical practice.
Results
Local clinical practice guidelines pointed to the importance of optimization strategies to select the most suitable patients in remission. However, there is currently no validated algorithm to select these patients. The literature search retrieved 1,809 references. There were no primary studies identified and only two ongoing randomized controlled trials met the inclusion criteria: REMRABIT-Plus (OPTIBIO) and PATIO. There were some important differences between the studies with respect to the patient populations and stages of the disease. Based on these results, the review will continue in “living evidence” mode, with the aim of collecting new evidence as it becomes available.
Conclusions
There is currently an unfulfilled need between research projects in the academic context and HTA that can be resolved with ED. Collaboration in the early stages of technology development is fundamental to improving the appropriateness of data produced for future HTAs. This will facilitate quality decision-making on the incorporation of procedures into the National Health Service.
The management of the COVID-19 pandemic is a challenge for Health Technology Assessment (HTA) methodology due to the need to formulate evidence-based recommendations in times of uncertainty in minimal time - for a large number of publications and with changing or even contradictory information. Living systematic reviews (LSRs) are systematic reviews that are continually updated, incorporating relevant new evidence as it becomes available. Since the COVID-19 pandemic fits all criteria to perform LSRs: (i) the Review question is a particular priority for decision-making, (ii) there is an high level of uncertainty about the existing evidence, and (iii) there is likely to be emerging evidence that will impact on the conclusions of the LSR, the aim of which is to analyze the role of LSRs as an innovative approach to HTA in recent years, and its impact on the management of the pandemic.
Methods
A systematic search of LSRs (published or protocols) was run on the main biomedical databases (Medline, Embase and Cochrane Library) in November 2020 and it was rerun in June 2021 without time limit. The results will be analyzed and classified by year and category (epidemiology, treatment, prognosis, symptoms, diagnosis and vaccines).
Results
The literature research has returned a total of 187 publications. The LSR concept emerged in 2014, from which some LSRs began to be published, but an exponential increase has been observed in 2020 with 76 references of which 66 percent were focused on the SARS-CoV-2. By category, 81.8 percent were focused on treatment, 41.8 percent on epidemiology, 20.9 percent on rehabilitation, 15.1 percent on diagnosis, 10.2 percent on prognosis and 2.2 percent on symptoms until June 2021. There wasn't any LSR for vaccines and 28 percent was focused on other fields.
Conclusions
LSRs are particularly important during the COVID-19 pandemic, with research evidence emerging rapidly, current evidence being uncertain, and new research changing policy or decisions on health. The majority of LSRs published up to June 2021 were focused on the treatment of COVID-19.
The European population is aging rapidly. The number of Europeans aged over sixty-five will double in the next fifty years. Active and healthy aging is a societal challenge shared by all European countries, but also an opportunity. The World Health Organization indicated that frailty has become an indicator of lack of successful aging. Therefore, identification of frail elderly is becoming important. However, there are many different screening tools that are currently used to identify frailty. The optimal test should have the capacity to easily identify from the community-dwelling population, those older people at risk of adverse outcomes. During the past years, gait speed has been repeatedly reported as an appealing instrument as a screening tool to detect frailty.
Methods
Systematic review of literature on gait speed as predictor of frailty was performed.
Results
A total of 992 articles were retrieved from the literature search and only eleven studies met the inclusion criteria. Frailty is a common geriatric syndrome, characterized by decreased reserve and increased vulnerability to adverse outcomes, including falls, hospitalization, institutionalization and death. Despite frailty is being increasingly recognized in the literature, there is a paucity of direct evidence to guide interventions to reduce frailty. Many single and composite tools to detect the frailty have been proposed but none is consensual, most are time-consuming while evaluating different domains of impairments, and many are not validated. Gait speed seems to be a single, reliable, valid, sensitive, cheap, quick and simple tool that identifies frailty people. However, the way to perform the test parameters vary widely, influencing interpretations of physical performance.
Conclusions
The evidence recommends to detect frailty in people in order to achieve an active and healthy ageing. Gait speed could be a suitable predictor to identify frailty although this systematic review found many differences between the gait speed protocols used in clinical practice. It is necessary to establish a standard protocol of gait speed agreed by experts in the area on frailty to be implemented with success in clinical practice.
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