ABSTRACTSocietal trust in research and innovation is predicated on factors such as governance, safety, and responsible development. These are often thought of as regulatory matters, but regulation ...may be ill-adapted for many novel technologies. Anticipatory governance, potentially in the form of responsible innovation (RI), can help to provide this adaptivity and granularity. However, RI remains new to many fields, and can be difficult to apply. This paper analyses the literature to identify challenges for RI and lessons from other domain frameworks, synthesising this with empirical evidence to develop a Framework. The Beehive Framework is a straightforward to use, translatable scaffold, with accompanying guidance for mapping and recording RI within projects of various scales and types. Its iterative process model approach to RI contains elements of project management methodology, and captures information gathered during the processes of RI. It records these processes for further iteration, and comparison between projects.
Autonomous Vehicles (AVs) collect a vast amount of data during their operation (MBs/sec). What data is recorded, who has access to it, and how it is analysed and used can have major technical, ...ethical, social, and legal implications. By embedding Responsible Innovation (RI) methods within the AV lifecycle, negative consequences resulting from inadequate data logging can be foreseen and prevented. An RI approach demands that questions of societal benefit, anticipatory governance, and stakeholder inclusion, are placed at the forefront of research considerations. Considered as foundational principles, these concepts create a contextual mindset for research that will by definition have an RI underpinning as well as application. Such an RI mindset both inspired and governed the genesis and operation of a research project on autonomous vehicles. The impact this had on research outlines and workplans, and the challenges encountered along the way are detailed, with conclusions and recommendations for RI in practice.
Widespread adoption of artificial intelligence (AI) technologies is substantially affecting the human condition in ways that are not yet well understood. Negative unintended consequences abound ...including the perpetuation and exacerbation of societal inequalities and divisions via algorithmic decision making. We present six grand challenges for the scientific community to create AI technologies that are human-centered, that is, ethical, fair, and enhance the human condition. These grand challenges are the result of an international collaboration across academia, industry and government and represent the consensus views of a group of 26 experts in the field of human-centered artificial intelligence (HCAI). In essence, these challenges advocate for a human-centered approach to AI that (1) is centered in human well-being, (2) is designed responsibly, (3) respects privacy, (4) follows human-centered design principles, (5) is subject to appropriate governance and oversight, and (6) interacts with individuals while respecting human's cognitive capacities. We hope that these challenges and their associated research directions serve as a call for action to conduct research and development in AI that serves as a force multiplier towards more fair, equitable and sustainable societies.
Tremor in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is common, often unresponsive to treatment, and may contribute to disability. We aim to investigate whether tremor is ...associated with disability as measured in daily practice and clinical trials, independent of other impairments. We included 76 CIDP patients in this cross‐sectional study. We assessed tremor with the Tremor Research Group essential tremor rating assessment scale (TETRAS) and the Fahn–Tolosa–Marin clinical rating scale (FTM). Disability was measured with the inflammatory Rasch‐built overall disability scale (I‐RODS) and the adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT‐DS, categorized separately in arm score, or total score). Impairments including strength, sensory impairment, and fatigue were measured using specific impairment scales. We tested whether “the presence of a clinically relevant tremor” (based on TETRAS and FTM) or “tremor severity” (FTM part B sum score) was associated with disability scores (I‐RODS, INCAT‐DS total score, and INCAT‐DS arm score), independent of the impairment scores, using multivariate regression. Both “the presence of a clinically relevant tremor” and “tremor severity” were significantly associated with disability measured by the INCAT‐DS (arm score and total score), but not the I‐RODS, independent of strength, sensory impairment, and fatigue. The explained variances were low. Clinically relevant tremor can (partly) explain disability in CIDP, as measured with the INCAT‐DS, independent of muscle strength, sensory deficits, and fatigue. To assess disease activity in CIDP patients with tremor, both impairment and disability outcomes should be assessed, as disability is caused partly by tremor while the effect of immunotherapy on tremor seems limited.
In patients with aneurysmal subarachnoid haemorrhage, short-term antifibrinolytic therapy with tranexamic acid has been shown to reduce the risk of rebleeding. However, whether this treatment ...improves clinical outcome is unclear. We investigated whether ultra-early, short-term treatment with tranexamic acid improves clinical outcome at 6 months.
In this multicentre prospective, randomised, controlled, open-label trial with masked outcome assessment, adult patients with spontaneous CT-proven subarachnoid haemorrhage in eight treatment centres and 16 referring hospitals in the Netherlands were randomly assigned to treatment with tranexamic acid in addition to care as usual (tranexamic acid group) or care as usual only (control group). Tranexamic acid was started immediately after diagnosis in the presenting hospital (1 g bolus, followed by continuous infusion of 1 g every 8 h, terminated immediately before aneurysm treatment, or 24 h after start of the medication, whichever came first). The primary endpoint was clinical outcome at 6 months, assessed by the modified Rankin Scale, dichotomised into a good (0–3) or poor (4–6) clinical outcome. Both primary and safety analyses were according to intention to treat. This trial is registered at ClinicalTrials.gov, NCT02684812.
Between July 24, 2013, and July 29, 2019, we enrolled 955 patients; 480 patients were randomly assigned to tranexamic acid and 475 patients to the control group. In the intention-to-treat analysis, good clinical outcome was observed in 287 (60%) of 475 patients in the tranexamic acid group, and 300 (64%) of 470 patients in the control group (treatment centre adjusted odds ratio 0·86, 95% CI 0·66–1·12). Rebleeding after randomisation and before aneurysm treatment occurred in 49 (10%) patients in the tranexamic acid and in 66 (14%) patients in the control group (odds ratio 0·71, 95% CI 0·48–1·04). Other serious adverse events were comparable between groups.
In patients with CT-proven subarachnoid haemorrhage, presumably caused by a ruptured aneurysm, ultra-early, short-term tranexamic acid treatment did not improve clinical outcome at 6 months, as measured by the modified Rankin Scale.
Fonds NutsOhra.
To investigate whether staff radiologists working in nonacademic hospitals can adequately rule out subarachnoid hemorrhage (SAH) on head CT <6 hours after headache onset.
In a multicenter, ...retrospective study, we studied a consecutive series of patients presenting with acute headache to 11 nonacademic hospitals. Inclusion criteria were (1) normal level of consciousness without focal deficits, (2) head CT <6 hours after headache onset and reported negative for the presence of SAH by a staff radiologist, and (3) subsequent CSF spectrophotometry. Two neuroradiologists and one stroke neurologist from 2 academic tertiary care centers independently reviewed admission CTs of patients with CSF results that were considered positive for presence of bilirubin according to local criteria. We investigated the negative predictive value for detection of SAH by staff radiologists in nonacademic hospitals on head CT in patients scanned <6 hours after onset of acute headache.
Of 760 included patients, CSF analysis was considered positive for bilirubin in 52 patients (7%). Independent review of these patients' CTs identified one patient (1/52; 2%) with a perimesencephalic nonaneurysmal SAH. Negative predictive value for detection of subarachnoid blood by staff radiologists working in a nonacademic hospital was 99.9% (95% confidence interval 99.3%-100.0%).
Our results support a change of practice wherein a lumbar puncture can be withheld in patients with a head CT scan performed <6 hours after headache onset and reported negative for the presence of SAH by a staff radiologist in the described nonacademic setting.
Summary Background There is insufficient evidence to support use of occupational therapy interventions for patients with Parkinson's disease. We aimed to assess the efficacy of occupational therapy ...in improving daily activities of patients with Parkinson's disease. Methods We did a multicentre, assessor-masked, randomised controlled clinical trial in ten hospitals in nine Dutch regional networks of specialised health-care professionals (ParkinsonNet), with assessment at 3 months and 6 months. Patients with Parkinson's disease with self-reported difficulties in daily activities were included, along with their primary caregivers. Patients were randomly assigned (2:1) to the intervention or control group by a computer-generated minimisation algorithm. The intervention consisted of 10 weeks of home-based occupational therapy according to national practice guidelines; control individuals received usual care with no occupational therapy. The primary outcome was self-perceived performance in daily activities at 3 months, assessed with the Canadian Occupational Performance Measure (score 1–10). Data were analysed using linear mixed models for repeated measures (intention-to-treat principle). Assessors monitored safety by asking patients about any unusual health events during the preceding 3 months. This trial is registered with ClinicalTrials.gov , NCT01336127. Findings Between April 14, 2011, and Nov 2, 2012, 191 patients were randomly assigned to the intervention group (n=124) or the control group (n=67). 117 (94%) of 124 patients in the intervention group and 63 (94%) of 67 in the control group had a participating caregiver. At baseline, the median score on the Canadian Occupational Performance Measure was 4·3 (IQR 3·5–5·0) in the intervention group and 4·4 (3·8–5·0) in the control group. At 3 months, these scores were 5·8 (5·0–6·4) and 4·6 (3·8–5·5), respectively. The adjusted mean difference in score between groups at 3 months was in favour of the intervention group (1·2; 95% CI 0·8–1·6; p<0·0001). There were no adverse events associated with the study. Interpretation Home-based, individualised occupational therapy led to an improvement in self-perceived performance in daily activities in patients with Parkinson's disease. Further work should identify which factors related to the patient, environmental context, or therapist might predict which patients are most likely to benefit from occupational therapy. Funding Prinses Beatrix Spierfonds and Parkinson Vereniging.
It is unknown whether warfarin or aspirin therapy is superior for patients with heart failure who are in sinus rhythm.
We designed this trial to determine whether warfarin (with a target ...international normalized ratio of 2.0 to 3.5) or aspirin (at a dose of 325 mg per day) is a better treatment for patients in sinus rhythm who have a reduced left ventricular ejection fraction (LVEF). We followed 2305 patients for up to 6 years (mean ±SD, 3.5±1.8). The primary outcome was the time to the first event in a composite end point of ischemic stroke, intracerebral hemorrhage, or death from any cause.
The rates of the primary outcome were 7.47 events per 100 patient-years in the warfarin group and 7.93 in the aspirin group (hazard ratio with warfarin, 0.93; 95% confidence interval CI, 0.79 to 1.10; P=0.40). Thus, there was no significant overall difference between the two treatments. In a time-varying analysis, the hazard ratio changed over time, slightly favoring warfarin over aspirin by the fourth year of follow-up, but this finding was only marginally significant (P=0.046). Warfarin, as compared with aspirin, was associated with a significant reduction in the rate of ischemic stroke throughout the follow-up period (0.72 events per 100 patient-years vs. 1.36 per 100 patient-years; hazard ratio, 0.52; 95% CI, 0.33 to 0.82; P=0.005). The rate of major hemorrhage was 1.78 events per 100 patient-years in the warfarin group as compared with 0.87 in the aspirin group (P<0.001). The rates of intracerebral and intracranial hemorrhage did not differ significantly between the two treatment groups (0.27 events per 100 patient-years with warfarin and 0.22 with aspirin, P=0.82).
Among patients with reduced LVEF who were in sinus rhythm, there was no significant overall difference in the primary outcome between treatment with warfarin and treatment with aspirin. A reduced risk of ischemic stroke with warfarin was offset by an increased risk of major hemorrhage. The choice between warfarin and aspirin should be individualized. (Funded by the National Institute of Neurological Disorders and Stroke; WARCEF ClinicalTrials.gov number, NCT00041938.).
Innovations and efficiencies in digital technology have lately been depicted as paramount in the green transition to enable the reduction of greenhouse gas emissions, both in the information and ...communication technology (ICT) sector and the wider economy. This, however, fails to adequately account for rebound effects that can offset emission savings and, in the worst case, increase emissions. In this perspective, we draw on a transdisciplinary workshop with 19 experts from carbon accounting, digital sustainability research, ethics, sociology, public policy, and sustainable business to expose the challenges of addressing rebound effects in digital innovation processes and associated policy. We utilize a responsible innovation approach to uncover potential ways forward for incorporating rebound effects in these domains, concluding that addressing ICT-related rebound effects ultimately requires a shift from an ICT efficiency-centered perspective to a “systems thinking” model, which aims to understand efficiency as one solution among others that requires constraints on emissions for ICT environmental savings to be realized.
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Information communication technology (ICT)’s environmental impact must be considered in digital innovation and associated policy to mitigate ICT’s climate change contribution. A proposed solution to reduce ICT emissions is by improving efficiency, yet this fails to consider rebound effects where efficiency improvements offset emissions savings or increase emissions. In this perspective, we reveal insights from a transdisciplinary workshop that identified challenges for why rebound effects are difficult to include in innovation and policy. From this, we call researchers to (1) find new ways of presenting rebound effects to digital innovators and policymakers; (2) gather cross-disciplinary evidence of ICT rebound effects; and (3) transparently analyze ICT’s environmental, societal, and economic impacts together. We also call for a systems thinking approach to addressing ICT’s environmental impacts, whereby a solution to rebound effects becomes visible: efficiencies under emission constraints.
Rebound effects occur in the digital sector when ICT efficiency improvements offset emissions savings or increase emissions. These must be considered in digital innovation and associated policy for sustainable ICT; however, there are key challenges to this that we identify through a transdisciplinary workshop and discuss in this perspective. We call for future work to address these challenges and to take a systems thinking approach for considering ICT’s environmental impacts. From this, a solution to rebound effects becomes visible: efficiencies under emissions constraints.
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