Search

AimThe aim of this study was to examine how new technologies in late-stage clinical trials might address unmet patient, practitioner or caregiver need for faecal incontinence (FI) over the next 5 years.MethodsHorizon scanning techniques were used to provide insights into the current landscape of emerging health technologies. A search was performed across clinical trial registries using the National Institute for Health Research Innovation Observatory’s ScanMedicine database (scanmedicine.com) to identify new, emerging interventions or health technologies (drugs, medical devices or diagnostics) that were addressing or investigating FI. Trials were then screened for relevance to FI in a non-blinded duplicate manner.Results1163 records were identified through searching ScanMedicine, and 136 trials were included in the final data extraction and mapping process. The most frequently investigated FI intervention topics were complementary therapies (n=17, 12.4%); electrical stimulation (n=13, 9.5%); pelvic floor muscle training/biofeedback/sphincter exercises (n=13, 9.5%) and implanted sacral nerve stimulation (n=12, 8.7%). There was little evidence of new pharmaceutical technologies in development. Existing drugs are, however, being repurposed and trialled for the treatment of FI (eg, linaclotide, colesevelam). Such repurposed drugs often have lower development costs, shorter timelines and report lower failure rates compared with new pharmaceutical products.ConclusionOverall, the innovation space as indicated by late-stage clinical trials related to FI, is relatively stagnant. Patients, carers and healthcare professionals are demanding more effective treatment and containment options; however, these are unlikely to come to market in the immediate future.

IntroductionFecal incontinence (FI) is the involuntary loss of feces and can affect up to 17 percent of community dwelling individuals, rising to 40 percent of older people in residential care homes. There is limited up-to-date evidence which formally set research priorities addressing FI. This project aimed to identify research topics of highest importance to key FI stakeholders.MethodsAn evidence gap map was produced incorporating three streams of evidence coded against predefined topic domains. The evidence streams included: emerging evidence identified through horizon scanning; existing evidence identified through systematic searches of bibliographic databases; and key FI stakeholder insights collected through an international survey. Findings were presented as a visual map to facilitate knowledge exchange during an online workshop with a purposeful sample of multidisciplinary stakeholders. The identified gaps in research were explored to see whether they were deemed representative of unmet needs, and as such, areas of priority to key FI stakeholders. Ideation techniques and group discussions were used to refine and rank priority areas.ResultsOverall, there was a mismatch between the existing and emerging evidence, and the priorities of key FI stakeholders. New pharmaceutical and medical technology innovations were limited. Eight percent of early-stage trials identified were concerned with the use of repurposed drugs. Within the existing evidence base, individual bowel management strategies and treatments were examined, however, key FI stakeholders desired interventions to improve patient education and the psychological aspects of living with FI. The five priority topics identified in order of importance are as follows: psychological support; lifestyle interventions; long-term effects; education; and constipation.ConclusionsThe robust methodology used to identify priority topics were successful in identifying broad and wide-ranging areas of importance to key stakeholders. The evidence gap map was a useful visual tool to facilitate knowledge exchange and highlight where research efforts have been focused historically, identifying a mismatch between the existing evidence base and what stakeholders consider important.

Diagnostic testing remains the backbone of the coronavirus disease 2019 (COVID-19) response, supporting containment efforts to mitigate the outbreak. The severity of this crisis and increasing capacity issues associated with polymerase chain reaction (PCR)-based testing, accelerated the development of diagnostic solutions to meet demands for mass testing. The National Institute for Health Research (NIHR) Innovation Observatory is the national horizon scanning organization in England. Since March, the Innovation Observatory has applied advanced horizon scanning methodologies and tools to compile a diagnostic landscape, based upon data captured for molecular (MDx) and immunological (IDx) based diagnostics (commercialized/in development), for the diagnosis of SARS-CoV-2. In total we identified and tracked 1608 diagnostics, produced by 1045 developers across 54 countries. Our dataset shows the speed and scale in which diagnostics were produced and provides insights into key periods of development and shifts in trends between MDx and IDx solutions as the pandemic progressed. Stakeholders worldwide required timely and detailed intelligence to respond to major challenges, including testing capacity and regulatory issues. Our intelligence assisted UK stakeholders with assessing priorities and mitigation options throughout the pandemic. Here we present the global evolution of diagnostic innovations devised to meet changing needs, their regulation and trends across geographical regions, providing invaluable insights into the complexity of the COVID-19 phenomena.