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The aim of this policy article is twofold: (i) to provide a summary and update of recent important policy developments, in particular relevant guidance on the use of real-world data/real-world evidence (RWD/RWE) by health technology assessment (HTA) bodies and (ii) to set out our policy recommendations on how the different elements of an “RWE framework” we have previously developed could support, further enhance and facilitate the use of RWE for HTA purposes and by HTA bodies and payers.
Methods
We undertook a targeted review and analysis of recent important policy developments. The aim was to build on our recommendations from previous work on the “RWE Framework,” and consider how the relevant tools from our Framework can further enhance and facilitate the use of RWE for HTA purposes and by HTA bodies/payers.
Results
We provide eight conditions that we argue would, in combination, constitute the optimal use and acceptance of RWD/RWE for HTA. We believe that, should the eight conditions hold, RWD/RWE would enable more efficient access to medicines and healthcare technologies for patients.
Conclusions
High-quality, fit-for-purpose RWD/RWE can and should be used more frequently in HTA. Multi-stakeholder and cross-geography collaborative partnerships are needed to align on best practices to optimize the evidence that needs to be generated to satisfy all stakeholders’ needs.
Humankind came to substances early. Poppy pods have been found with Neanderthal burials and spiritual and other group practices, still seen today but with millennia behind them, bear witness to the role of induced experiential change in human social evolution. Despite generations of history, the knowledge to unlock what mind-altering substances might do and the substrates through which they do it has only started to reveal itself within living memory through development of innovative investigative methods and an expanding cast of centrally acting compounds with clinical and laboratory potential.
A widening, if somewhat artificial, distinction has emerged where those who seek to modify brain systems with patients are considered psychopharmacologists, while those seeking to unravel mechanisms are considered neuropharmacologists. Expertise may differ, but the quest of clinician and basic scientist is the same, each benefitting from knowledge of the other.
Few studies have examined the genetic population structure of vector-borne microparasites in wildlife, making it unclear how much these systems can reveal about the movement of their associated hosts. This study examined the complex host–vector–microbe interactions in a system of bats, wingless ectoparasitic bat flies (Nycteribiidae), vector-borne microparasitic bacteria (Bartonella) and bacterial endosymbionts of flies (Enterobacterales) across an island chain in the Gulf of Guinea, West Africa. Limited population structure was found in bat flies and Enterobacterales symbionts compared to that of their hosts. Significant isolation by distance was observed in the dissimilarity of Bartonella communities detected in flies from sampled populations of Eidolon helvum bats. These patterns indicate that, while genetic dispersal of bats between islands is limited, some non-reproductive movements may lead to the dispersal of ectoparasites and associated microbes. This study deepens our knowledge of the phylogeography of African fruit bats, their ectoparasites and associated bacteria. The results presented could inform models of pathogen transmission in these bat populations and increase our theoretical understanding of community ecology in host–microbe systems.
We assessed the implementation of telehealth-supported stewardship activities in acute-care units and long-term care (LTC) units in Veterans’ Administration medical centers (VAMCs).
Design:
Before-and-after, quasi-experimental implementation effectiveness study with a baseline period (2019–2020) and an intervention period (2021).
Setting:
The study was conducted in 3 VAMCs without onsite infectious disease (ID) support.
Participants:
The study included inpatient providers at participating sites who prescribe antibiotics.
Intervention:
During 2021, an ID physician met virtually 3 times per week with the stewardship pharmacist at each participating VAMC to review patients on antibiotics in acute-care units and LTC units. Real-time feedback on prescribing antibiotics was given to providers. Additional implementation strategies included stakeholder engagement, education, and quality monitoring.
Methods:
The reach–effectiveness–adoption–implementation–maintenance (RE-AIM) framework was used for program evaluation. The primary outcome of effectiveness was antibiotic days of therapy (DOT) per 1,000 days present aggregated across all 3 sites. An interrupted time-series analysis was performed to compare this rate during the intervention and baseline periods. Electronic surveys, periodic reflections, and semistructured interviews were used to assess other RE-AIM outcomes.
Results:
The telehealth program reviewed 502 unique patients and made 681 recommendations to 24 providers; 77% of recommendations were accepted. After program initiation, antibiotic DOT immediately decreased in the LTC units (−30%; P < .01) without a significant immediate change in the acute-care units (+16%; P = .22); thereafter DOT remained stable in both settings. Providers generally appreciated feedback and collaborative discussions.
Conclusions:
The implementation of our telehealth program was associated with reductions in antibiotic use in the LTC units but not in the smaller acute-care units. Overall, providers perceived the intervention as acceptable. Wider implementation of telehealth-supported stewardship activities may achieve reductions in antibiotic use.
This paper reports the results of the collaboration within the European initiative of new Reimbursement and aCCess Approaches (EUreccA) which is concerned with the use of real-world evidence (RWE) in health technology assessment (HTA) decision-making. The work grew from the observation of a large, very experienced group of HTA practitioners which found that the use of RWE varied depending on the type of question asked and the particulars of the data source(s) used. We set out to examine how RWE is used in HTA decision-making and to make proposals on its facilitation.
Methods
Literature reviews covering earlier reviews of RWE use, academic papers, and HTA agency websites were combined with case studies involving interviews with decision-makers in four countries (England, France, Italy, Sweden) to identify the circumstances of breakdown of RWE use and to build a categorization of the uses of RWE and associated difficulties. This evidence supported the creation of a taxonomy of pairings of data sources and the questions they were used to address. The face validity of the approach was tested at an advisory board of senior HTA practitioners.
Results
In total, 27 questions were identified and 10 types of data source, giving 270 pairings. These pairings were linked to relevant methods guidance and to examples of their use, itemizing HTA issues and decisions made. Reports are being prepared for publication, covering the detail of the methods of the literature searches; methods of the country case studies; a description of the taxonomy; and guidance on governance.
Conclusions
When using RWE in HTA decision-making, the detail of the particular data sources and question addressed matter. Recently, both the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Real-World Transparency Initiative have argued for a registry of the uses of RWE. The work described here offers a starting classification of the material that should be held in such a registry, and which in itself could be developed by the stakeholders, both agencies and companies, that use it, furthering trust and confidence.
This book offers an empirically-based view on Europeans’ interconnections in everyday life. It looks at the ways in which EU residents have been getting closer across national frontiers. The book considers how people reconcile their increasing cross-border interconnections and a politically separating Europe of nation states and national interests.
Early in the fall of 1964, the governor of Mississippi, Paul B. Johnson, embarked on an unusual journey. His destination was the small railroad city of McComb, located halfway between Jackson, the state’s capitol, and New Orleans. Awaiting him at the end of the 80-mile drive were the area’s two top policing officials: McComb Police Chief George Guy and Pike County Sheriff R. W. Warren. The situation was urgent for all concerned, as McComb had become a steady presence in the national news for its charged racial situation – a series of vicious bombings had targeted supporters of a voter registration campaign mounted by a coalition of civil rights organizations. Local residents and national reporters alike were in on the open secret: the bombings had been perpetrated by members of local chapters of the Ku Klux Klan (KKK), a violent vigilante outfit that had mobilized extensively in McComb over the past year.
Darwin's frogs Rhinoderma darwinii and Rhinoderma rufum are the only known species of amphibians in which males brood their offspring in their vocal sacs. We propose these frogs as flagship species for the conservation of the Austral temperate forests of Chile and Argentina. This recommendation forms part of the vision of the Binational Conservation Strategy for Darwin's Frogs, which was launched in 2018. The strategy is a conservation initiative led by the IUCN SSC Amphibian Specialist Group, which in 2017 convened 30 governmental, non-profit and private organizations from Chile, Argentina and elsewhere. Darwin's frogs are iconic examples of the global amphibian conservation crisis: R. rufum is categorized as Critically Endangered (Possibly Extinct) on the IUCN Red List, and R. darwinii as Endangered. Here we articulate the conservation planning process that led to the development of the conservation strategy for these species and present its main findings and recommendations. Using an evidence-based approach, the Binational Conservation Strategy for Darwin's Frogs contains a comprehensive status review of Rhinoderma spp., including critical threat analyses, and proposes 39 prioritized conservation actions. Its goal is that by 2028, key information gaps on Rhinoderma spp. will be filled, the main threats to these species will be reduced, and financial, legal and societal support will have been achieved. The strategy is a multi-disciplinary, transnational endeavour aimed at ensuring the long-term viability of these unique frogs and their particular habitat.
Antipsychotic depot injections can improve adherence compared to tablets. However, depot prescribing practices differ amongst psychiatrists. Previously, some clinicians perceived an “image” problem for typical antipsychotic depots. This study investigated psychiatrists’ attitudes and knowledge concerning antipsychotic depots (typical and atypical) in an era when patient choice is a pertinent issue.
Method:
Cross-sectional postal survey of consultant psychiatrists working in NorthWest England. A pre-existing questionnaire on clinicians’ attitudes and knowledge regarding depots was updated.
Results:
The sample comprised 102 consultant psychiatrists (response rate 102/143, 71%). Their use of depots over the past 5 years had: decreased (50%), not changed (27%), increased (23%). In a forced-choice selection of factors that would persuade them to use depots more, the factor cited as most important was ‘having more atypicals available in long-acting depot form’ (43%). Most regarded depots as being associated with better compliance (89%) and reduced relapse rates (98%) compared to oral medication but only 62% agreed that depots can be used for those with first episode psychosis. A significant minority (33%) believed patients always prefer to have oral medication instead of a depot. 68% believed that patients taking medication of their own free choice is more likely for oral than depot.
Conclusions:
During the last 5 years, overall depot prescribing rates have reduced. Most regarded depots as offering better adherence and reduced relapse rates but some remain concerned about the acceptability of depots to patients. These clinician concerns are important but, if extreme, could compromise medication choices offered to patients.
Previously, when only typical antipsychotic depot injections were available, some clinicians perceived depots as having an “image” problem despite them being associated with reduced rates of rehospitalisation when compared to tablets. This study investigated psychiatrists’ attitudes and knowledge concerning depots (typical and atypical) and whether they had changed over time.
Method:
Cross-sectional postal survey of consultant psychiatrists working in NorthWest England. A pre-existing questionnaire on clinicians’ attitudes and knowledge regarding depots was updated. Results were compared with a former sample (SouthEast England, 2001: N=143).
Results:
The sample comprised 102 consultant psychiatrists (response rate 71%). Depot use over the past 5 years had: decreased (50%), not changed (27%), increased (23%). Psychiatrists with decreased depot use had significantly lower scores for the side effects knowledge subscale than those who had unchanged or increased rates of depot use (mean 51.5% vs 54.8%, p=0.029). When compared to psychiatrists sampled five years previously, our current participants had more favourable patient-focussed attitudes (63.5% vs 60.4%, p=0.034); other subscales did not differ. Item-by-item analysis revealed specific changes over time including significantly less respondents regarding depots as: (i) compromising patient autonomy (mean 0.99 vs 1.28, p=0.036); being stigmatising (1.88 vs 2.42, p=0.002); being old fashioned (1.49 vs 2.04, p=0.002).
Conclusions:
During the period that an atypical antipsychotic depot has been available, and depot prescribing rates have reduced, some attitudes have changed. These mainly encompass aspects regarding the patient rather than the depot injection and include reducing concerns about stigma and autonomy although concerns about patient acceptance continue.
Sodium valproate and related preparations have recently undergone regulatory review following concern about effects on the unborn child and doctors' failure to communicate risk. The issues are wider. Valproate is overused in psychiatry based on the false perception that ‘ease’ of use equates to better safety than alternatives. Valproic acid can disrupt fundamental physiological processes, the consequences of which are poorly understood and little discussed in the psychiatric literature. Valproate may be useful in a small number of patients with bipolar disorder but current prescribing patterns are unjustified. Perception needs to change.
Declaration of interest
D.C.O. is psychiatric commissioner on the Commission on Human Medicines and a member of the European Medicines Agency's Scientific Advisory Group on Psychiatry. He chaired the European Medicines Agency's review of the psychiatric use of valproate in pregnancy and women of childbearing potential.
Early globalisation theorists (Harvey 1989; Giddens 1991; Beck 2000) emphasised the significance of ‘time–space compression’ – the extent to which greater and easier mobility reduced the significance of local face-to-face ties. Others articulated a new social and spatial division between global elites and local masses (Castells 2000; Bauman 1998), a theme which rehearsed and gave new bite to the familiar distinction between sedentary ‘locals’ and mobile ‘cosmopolitans’, which had long been observed in the sociology and anthropology of community (Merton 1957; Watson 1964). These trends were also seen by sociologists embracing the mobilities turn (Urry 2000), as articulating the declining significance of borders, and fuelled the critique of ‘methodological nationalism’ which has gathered pace over the past two decades (Beck and Sznaider 2006).
This chapter recognises the power of these trends, and the extent and significance of mundane, or what we call ‘everyday’ mobilities, of people, objects and information in the contemporary world. At the same time, it seeks to direct these observations onto a more balanced terrain in which we can see how such forms of mobility allow the consolidation of distinctive territorial and social identities. This recognition also has a long history, dating back to arguments according to which globalisation led not to the eradication of the local, but to ‘glocalisation’, as global processes acted to construct new kinds of local entities (Robertson 1995). These were similar to anthropological views which claimed that globalisation allowed the proliferation of different ‘scapes’ permitting intense, particularistic identities to develop (Appadurai 1996).
It is this more nuanced and critical perspective which has come to the fore since the start of the new century, as it has become clearer that transnational practices can actually facilitate the generation of nationally specific identifications and behaviours, and even new forms of nationalism. We need to go beyond simplistic contrasts between ‘cosmopolitans’ and ‘locals’: in this case, between those who are confined to a national scale of everyday life versus those who are more international or global, in order to demonstrate the importance of a more granular geography of worldly connections.