Managing Risk and Quality of AI in Healthcare: Are Hospitals Ready for Implementation?

Arian Ranjbar,1 Eilin Wermundsen Mork,1 Jesper Ravn,1 Helga Brøgger,2 Per Myrseth,2 Hans Peter Østrem,3 Harry Hallock2 1Medical Technology and E-Health, Akershus University Hospital, Lørenskog, Norway; 2Group Research and Development, DNV AS, Høvik, Norway; 3Business Assurance, DNV AS, Høvik, NorwayCorrespondence: Arian Ranjbar, Akershus University Hospital, Sykehusveien 25, 1478, Lørenskog, Norway, Tel +46700436768, Email [email protected]: Artificial intelligence (AI) provides a unique opportunity to help meet the demands of the future healthcare system. However, hospitals may not be well equipped to handle safe and effective development and/or procurement of AI systems. Furthermore, upcoming regulations such as the EU AI Act may enforce the need to establish new management systems, quality assurance and control mechanisms, novel to healthcare organizations. This paper discusses challenges in AI implementation, particularly potential gaps in current management systems (MS), by reviewing the harmonized standard for AI MS, ISO 42001, as part of a gap analysis of a tertiary acute hospital with ongoing AI activities. Examination of the industry agnostic ISO 42001 reveals a technical debt within healthcare, aligning with previous research on digitalization and AI implementation. To successfully implement AI with quality assurance in mind, emphasis should be put on the foundation and structure of the healthcare organizations, including both workforce and data infrastructure.Keywords: artificial intelligence, management systems, quality assurance, risk management, implementatio

Statistical EOF analysis of spatiotemporal glacier mass-balance variability: a case study of Mittivakkat Gletscher, SE Greenland

An Empirical Orthogonal Function (EOF) variance analysis was performed to map in detail the spatiotemporal variability in individual stake mass-balances (ba) on Mittivakkat Gletscher (MG) – in a region where at present five out of ~20.000 glaciers have mass-balance observations. The EOF analysis suggested that observed ba was summarized by two modes: EOF1 and EOF2 represented 80% (significant) and 6% (insignificant) of the explained variance, respectively. EOF1 captured a decline in ba that was uniformly distributed in space at all stakes. The decline was correlated with albedo observations and air temperature observations from nearby stations. EOF2, however, described variations in ba that were heterogeneously distributed among stakes and associated with local slope and aspect. Low elevation stakes (~<400 m a.s.l.) showed relatively negative (out of phase) correlation and higher elevated stakes relatively positive (in phase) eigenvector correlation values with EOF2. Such relatively negative and positive eigenvector correlation values were present where the constituted of exposed glacier ice or snow cover, respectively. The results from this study show how EOF analyses can provide information on spatiotemporal patterns of glacier mass-balance. Understanding such detailed variabilities in mass-balance on a Greenlandic glacier is of interest because a fifth of the Arctic contribution from glaciers and ice caps to sea-level rise originates from Greenland

SaferBirths bundle of care protocol: a stepped-wedge cluster implementation project in 30 public health-facilities in five regions, Tanzania

Background The burden of stillbirth, neonatal and maternal deaths are unacceptably high in low- and middle-income countries, especially around the time of birth. There are scarce resources and/or support implementation of evidence-based training programs. SaferBirths Bundle of Care is a well-proven package of innovative tools coupled with data-driven on-the-job training aimed at reducing perinatal and maternal deaths. The aim of this project is to determine the effect of scaling up the bundle on improving quality of intrapartum care and perinatal survival. Methods The project will follow a stepped-wedge cluster implementation design with well-established infrastructures for data collection, management, and analysis in 30 public health facilities in regions in Tanzania. Healthcare workers from selected health facilities will be trained in basic neonatal resuscitation, essential newborn care and essential maternal care. Foetal heart rate monitors (Moyo), neonatal heart rate monitors (NeoBeat) and skills trainers (NeoNatalie Live) will be introduced in the health facilities to facilitate timely identification of foetal distress during labour and improve neonatal resuscitation, respectively. Heart rate signal-data will be automatically collected by Moyo and NeoBeat, and newborn resuscitation training by NeoNatalie Live. Given an average of 4000 baby-mother pairs per year per health facility giving an estimate of 240,000 baby-mother pairs for a 2-years duration, 25% reduction in perinatal mortality at a two-sided significance level of 5%, intracluster correlation coefficient (ICC) to be 0.0013, the study power stands at 0.99. Discussion Previous reports from small-scale Safer Births Bundle implementation studies show satisfactory uptake of interventions with significant improvements in quality of care and lives saved. Better equipped and trained birth attendants are more confident and skilled in providing care. Additionally, local data-driven feedback has shown to drive continuous quality of care improvement initiatives, which is essential to increase perinatal and maternal survival. Strengths of this research project include integration of innovative tools with existing national guidelines, local data-driven decision-making and training. Limitations include the stepwise cluster implementation design that may lead to contamination of the intervention, and/or inability to address the shortage of healthcare workers and medical supplies beyond the project scope. Trial registration Name of Trial Registry: ISRCTN Registry. Trial registration number: ISRCTN30541755. Date of Registration: 12/10/2020. Type of registration: Prospectively Registered.publishedVersio

The micromorphology of glaciolacustrine varve sediments and their use for reconstructing palaeoglaciological and palaeoenvironmental change

Former glaciolacustrine systems are an important archive of palaeoglaciological, palaeoenvironmental and palaeoclimatic change. The annually laminated (varved) sediments that, under certain conditions, accumulate in former glacial lakes, offer a rare opportunity to reconstruct such changes (e.g. glacier advance and retreat cycles, glacier ablation trends, permafrost melt, nival events) at annual or even sub-annual temporal resolution. Data of this kind are desirable for their ability to guide and test numerical model simulations of glacier dynamics and palaeoclimatic change that occur over rapid time intervals, with implications for predicting future glacier response to climatic change, or the effects of weather and climate events on lake sedimentation. The most valuable records preserved in glaciolacustrine systems are continuous varved sequences formed in the distal parts of glacial lakes, where microscale lamination structures can accumulate relatively undisturbed. Technological advances, in the last few decades, have enabled improved characterisation of glaciolacustrine varve microfacies and the precise measurement of varve thickness at the micrometre scale. However, unlike in cognate fields (e.g. soil science), protocols for the robust and consistent description and interpretation of glaciolacustrine varve sediments are lacking. To fill this gap, and to provide a resource for future studies of glaciolacustrine varved sediments, this paper reviews the processes of sedimentation in glacial lake basins, and presents the defining microfacies characteristics of glacial varves using a descriptive protocol that uses consistent examination of grain size, sorting, structure, nature of contacts, development of plasmic fabrics and features such as dropgrains and intraclasts within individual laminations. These lamination types are then combined into lamination sets, whose structures can be interpreted as glaciolacustrine varves. Within this framework, we define five principal assemblages of glaciolacustrine varve microfacies which, if clearly identified in palaeoglaciolacustrine settings, enable more detailed palaeoenvironmental interpretations to be made. Finally, we discuss the utility and complexities of reconstructing the evolution of former glacial lake systems using varve microfacies and thickness datasets

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Teamkontraktens betydning for hvordan team arbeider og presterer : direkte og medierende effekter mellom teamkontrakt, arbeidsprosesser og prestasjoner

Studien har som formål å undersøke betydningen av teamkontrakt for hvordan team arbeider og presterer, samt å undersøke hvorvidt teamkontraktens påvirkning på prestasjon medieres av utvalgte sider ved arbeidsprosessen. Sammenhengene ble testet ved et eksperiment på 81 studentteam ved Norges Handelshøyskole. En andel av teamene ble manipulert ved at de utarbeidet en teamkontrakt første gang teamet var samlet. Teamkontraktene tok utgangspunkt i et utdelt forslag som ifølge våre antakelser skal kunne gjøre teamene bedre rustet for samarbeid. De resterende teamene gjennomførte i stedet en normal oppstartaktivitet i form av en mindre teamøvelse. Ved neste teamsamling gjennomførte begge de eksperimentelle gruppene en konkurranse-preget teamøvelse hvor resultater ble målt og spørreskjema ble utdelt etter øvelsen. Spørreskjemaet måler i hvilken grad teamene er fornøyd med egen prestasjon, samt variabler for kvaliteten på arbeidsprosessen i øvelsen. Prosessvariablene som er sett på er teamenes grad av oppgavefokus på resultat, person- og oppgaverelatert konfliktnivå, grad av støttende atferd og hvor bra de håndterte uforutsette hendelser. Vi finner at teamene med teamkontrakt vurderte egen prestasjon signifikant høyere, samt at de hadde signifikant bedre vurdering av arbeidsprosessen for alle målte variabler. Studien finner ikke at teamkontraktteamene hadde bedre objektive prestasjoner enn teamene uten team-kontrakt. Videre finner vi at effekten teamkontrakten hadde på egen vurdering av prestasjon medieres av teamenes grad av oppgavefokus på resultat, støttende atferd og evne til å håndtere uforutsette hendelser. Konflikt synes ikke å mediere denne effekten parallelt med de andre, men det kan ikke utelukkes at konflikt virker serielt på de andre prosessvariablene. Vi anbefaler at fremtidig forskning videre undersøker konfliktnivåets rolle i dette samspillet. Vi konkluderer med at forventningsavklaringer mellom teammedlemmene i oppstartsfasen er viktig for hvordan teamene samarbeider og til en viss grad presterer. Teamkontrakten synes å være et godt verktøy for forventningsavklaring

Dual bronchodilation in COPD: lung function and patient-reported outcomes &ndash; a review

David Price,1,2 Anders &Oslash;strem,3 Mike Thomas,4 Tobias Welte5 1Department of Primary Care Respiratory Medicine, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; 2Observational and Pragmatic Research Institute, Singapore; 3Gransdalen Legesenter, Oslo, Norway; 4Department of Primary Care Research, University of Southampton, Southampton, UK; 5Department of Pulmonary Medicine, Hannover Medical School, Hannover, Germany Abstract: Several fixed-dose combinations (FDCs) of long-acting bronchodilators (a long-acting muscarinic antagonist [LAMA] plus a long-acting &beta;2-agonist [LABA]) are available for the treatment of COPD. Studies of these FDCs have demonstrated substantial improvements in lung function (forced expiratory volume in 1 second) in comparison with their respective constituent monocomponents. Improvements in patient-reported outcomes (PROs), such as symptoms and health status, as well as exacerbation rates, have been reported compared with a LABA or LAMA alone, but results are less consistent. The inconsistencies may in part be owing to differences in study design, methods used to assess study end points, and patient populations. Nevertheless, these observations tend to support an association between improvements in forced expiratory volume in 1 second and improvements in symptom-based outcomes. In order to assess the effects of FDCs on PROs and evaluate relationships between PROs and changes in lung function, we performed a systematic literature search of publications reporting randomized controlled trials of FDCs. Results of this literature search were independently assessed by two reviewers, with a third reviewer resolving any conflicting results. In total, 22 Phase III randomized controlled trials of FDC bronchodilators in COPD were identified, with an additional study including a post-literature search (ten for indacaterol&ndash;glycopyrronium once daily, eight for umeclidinium&ndash;vilanterol once daily, three for tiotropium&ndash;olodaterol once daily, and two for aclidinium&ndash;formoterol twice daily). Results from these studies demonstrated that the LAMA&ndash;LABA FDCs significantly improved lung function compared with their component monotherapies or other single-agent treatments. Furthermore, LABA&ndash;LAMA combinations also generally improved symptoms and health status versus monotherapies, although some discrepancies between lung function and PROs were observed. Overall, the safety profiles of the FDCs were similar to placebo. Further research is required to examine more closely any relationship between lung function and PROs in patients receiving LABA&ndash;LAMA combinations. Keywords: chronic obstructive pulmonary disease, combination therapy, dyspnea, forced expiratory volume, health status, spirometr

Et bedre liv med KOLS: Erfaringer med en lavterskelmodell for lungerehabilitering i kommunehelsetjenesten

Hensikt: Beskrive erfaringer med en interprofesjonell lavterskelmodell for lungerehabilitering i kommunehelsetjenesten, sett med pasienter og fagpersoners øyne. Design og metode: Kvalitativt design med fokusgruppeintervju. Materiale: 20 pasienter, 10 kvinner og 10 menn, med gjennomsnittsalder på 71,4 år Funn: Det er behov for mer kunnskap om KOLS i kommunehelsetjenesten. Tilbud om oppfølging og henvisningsrutiner fra fastlegene er mangelfulle. Prosjektet har bidratt til å utvikle pasientkompetanse gjennom styrket opplevelse av egenkontroll og mestringsevne, samt gitt pasientene flere verktøy til å håndtere symptomer. Nye erfaringer med kroppen har endret pasientenes holdninger til egen sykdom og bidratt til en bedre hverdag og en lysere tro på fremtiden, men det er fortsatt en utfordring for mange å skulle fortsette å trene på egenhånd Konklusjon: Interprofesjonelle lavterskel rehabiliteringstilbud i regi av kommunehelsetjenesten viser lovende resultater, både med hensyn til gjennomførbarhet og gevinster for deltakerne. Rehabiliterings-tilbudet og fellesskapet i treningsgruppen har bidratt til trivsel, trygghet og bedret arbeidskapasitet i hverdagen. Det er utfordrende for personer med KOLS å klare å opprettholde gevinstene uten en eller annen form for oppfølging