Views of Implementers and Nonimplementers of Internet-Administered Cognitive Behavioral Therapy for Depression and Anxiety: Survey of Primary Care Decision Makers in Sweden.

BACKGROUND: Internet-administered cognitive behavioral therapy (ICBT) has been demonstrated to be an effective intervention for adults with depression and/or anxiety and is recommended in national guidelines for provision within Swedish primary care. However, the number and type of organizations that have implemented ICBT within primary care in Sweden is currently unclear. Further, there is a lack of knowledge concerning barriers and facilitators to ICBT implementation. OBJECTIVE: The two primary objectives were to identify and describe primary care organizations providing ICBT in Sweden and compare decision makers' (ie, directors of primary care organizations) views on barriers and facilitators to implementation of ICBT among ICBT implementers (ie, organizations that offered ICBT) and nonimplementers (ie, organizations that did not offer ICBT). METHODS: An online survey based on a checklist for identifying barriers and facilitators to implementation was developed and made accessible to decision makers from all primary care organizations in Sweden. The survey consisted of background questions (eg, provision of ICBT and number of persons working with ICBT) and barriers and facilitators relating to the following categories: users, therapists, ICBT programs, organizations, and wider society. RESULTS: The participation rate was 35.75% (404/1130). The majority (250/404, 61.8%) of participants were health care center directors and had backgrounds in nursing. Altogether, 89.8% (363/404) of the participating organizations provided CBT. A minority (83/404, 20.5%) of organizations offered ICBT. Most professionals delivering ICBT were psychologists (67/83, 80%) and social workers (31/83, 37%). The majority (61/83, 73%) of organizations had 1 to 2 persons delivering ICBT interventions. The number of patients treated with ICBT during the last 12 months was 1 to 10 in 65% (54/83) of the organizations, ranging between 1 and 400 treated patients across the whole sample. There were 9 significant (P<.05) differences out of 37 possible between implementers and nonimplementers. For example, more implementers (48/51, 94%) than nonimplementers (107/139, 76.9%) perceived few technical problems (P<.001), and more implementers (53/77, 68%) than nonimplementers (103/215, 47.9%) considered that their organization has resources to offer ICBT programs (P<.001). CONCLUSIONS: Despite research demonstrating the effectiveness of ICBT for depression and anxiety and national guidelines recommending its use, ICBT is implemented in few primary care organizations in Sweden. Several interesting differences between implementers and nonimplementers were identified, which may help inform interventions focusing on facilitating the implementation of ICBT.

An inductive exploration of the implementation knowledge of research funders.

BACKGROUND: Healthcare research funders may undertake various roles to facilitate implementation of research findings. Their ability to enact such roles depends on several factors, knowledge of implementation being one essential requirement. However, previous studies do not assess the type or level of knowledge about implementation that research funders possess. This paper therefore presents findings from a qualitative, inductive study of the implementation knowledge of research funders. Three aspects of this knowledge are explored, namely how research funders define implementation, their level of self-assessed implementation knowledge and the factors influencing their self-assessment of implementation knowledge. METHODS: Research funders (n = 18) were purposefully selected from a sample of research funding organisations in Sweden (n = 10). In-depth semi-structured interviews were conducted, recorded and transcribed verbatim. An inductive method using a systematic coding procedure was employed to derive the findings. RESULTS: The research funders defined implementation as either an outcome or a process, with the majority believing that implementation of healthcare research results demands a process, although its complexity varied in the research funders' view. They perceived their own level of implementation knowledge as either limited or substantial, with a majority regarding it as limited. Clinical research experience, clinical experience and task relevance were singled out as the clearest factors affecting the self-assessment of their own implementation knowledge. CONCLUSIONS: This study, the first to focus on implementation knowledge of research funders, demonstrates that they are a category of policy-makers who may possess knowledge, based on their previous professional experience, that is comparable to some important findings from implementation research. Consequently, the findings not only pinpoint the relevance of professional experience, but also reveal a lack of awareness and knowledge of the results of implementation research among research funders in charge of healthcare research.

Exploring the Obstacles to Implementing Economic Mechanisms to Stimulate Antibiotic Research and Development: A Multi-Actor and System-Level Analysis.

This Article examines the potential stakeholder-related obstacles hindering the implementation of mechanisms to re-ignite the development of novel antibiotics. Proposed economic models and incentives to drive such development include: Public Funding of Research and Development ("R&D"), Tax Incentives, Milestone Prizes, End Payments, Intellectual Property ("IP") and Exclusivity Extensions, Pricing and Reimbursement Incentives, Product Development Partnerships ("PDPs"), and the Options Market for Antibiotics model. Drawing on personal experience and understanding of the antibiotic field, as well as stakeholder consultation and numerous expert meetings within the DRIVE-AB project and Uppsala Health Summit 2015, the Authors identify obstacles attributable to the following actors: Universities and Research Institutes, Small and Medium-sized Enterprises ("SMEs"), Large Pharmaceutical Companies, Marketing Approval Regulators, Payors, Healthcare Providers, National Healthcare Authorities, Patients, and Supranational Institutions. The analysis also proposes a characterization and ranking of the difficulty associated with implementing the reviewed mechanisms. Public Funding of R&D, Pricing and Reimbursement Incentives, and PDPs are mechanisms expected to meet highly systemic barriers (i.e., obstacles across the entire antibiotic value chain), imposing greater implementation challenges in that they require convincing and involving several motivationally diverse actors in order to have much effect.

Challenges and shortcomings of antibacterial discovery projects.

OBJECTIVES: Antibacterial drug discovery activities are essential for filling clinical pipelines with promising clinical candidates. Little information is available about the challenges and shortcomings of small companies and academic institutions in performing these important discovery tasks. METHODS: We performed a content analysis of 463 reviewer comments on 91 funding applications of antibacterial drug discovery projects submitted to two major global funders between 2016 and 2020 that had not proceeded further in the selection process. This quality assessment was complemented with the inputs (via e-mail) from a panel involving six antibiotic research and development (R&D) experts with long-standing expertise and experience in antibiotic drug discovery. RESULTS: Common critical comments of reviewers are grouped into three main categories: scientific and technical shortcomings, unclear potential societal impact, and insufficient capability and expertise of the project team regarding the R&D process. Insufficient characterization of in vitro activity and/or testing of the hits/leads and insufficient antibacterial activity were the most common critical comments. Other areas of concern were insufficient or lack of differentiation from available drugs or projects with a long R&D history, and the research team's insufficient knowledge of a structured streamlined R&D process as reflected in severe gaps in the expertise of the R&D team. Little appreciation for the problem of the emergence of target-based resistance, especially in single-target approaches, and little awareness of toxicological issues, including approaches with historical liabilities were also commonly mentioned. The shortcomings identified through the analysis of funding applications are echoed by the results of the expert panel. DISCUSSION: Our analysis identified an urgent need of strengthening the support for antibacterial drug discovery teams to help more projects reach such a quality to be eligible for global funders and private investors.

Barriers to and Facilitators of the Implementation of Digital Mental Health Interventions as Perceived by Primary Care Decision Makers: Content Analysis of Structured Open-Ended Survey Data.

BACKGROUND: Digital mental health represents a way to increase access to evidence-based psychological support. However, the implementation of digital mental health in routine health care practice is limited, with few studies focusing on implementation. Accordingly, there is a need to better understand the barriers to and facilitators of implementing digital mental health. Existing studies have mainly focused on the viewpoints of patients and health professionals. Currently, there are few studies about barriers and facilitators from the perspective of primary care decision makers, that is, the persons responsible for deciding whether a given digital mental health intervention should be implemented in a primary care organization. OBJECTIVE: The objectives were to identify and describe barriers to and facilitators of the implementation of digital mental health as perceived by primary care decision makers, evaluate the relative importance of different barriers and facilitators, and compare barriers and facilitators reported by primary care decision makers who have versus have not implemented digital mental health interventions. METHODS: A web-based self-report survey was conducted with primary care decision makers responsible for the implementation of digital mental health in primary care organizations in Sweden. Answers to 2 open-ended questions about barriers and facilitators were analyzed through summative and deductive content analysis. RESULTS: The survey was completed by 284 primary care decision makers-59 (20.8%) decision makers representing implementers (ie, organizations that offered digital mental health interventions) and 225 (79.2%) respondents representing nonimplementers (ie, organizations that did not offer digital mental health interventions). Overall, 90% (53/59) of the implementers and 98.7% (222/225) of the nonimplementers identified barriers, and 97% (57/59) of the implementers and 93.3% (210/225) of the nonimplementers identified facilitators. Altogether, 29 barriers and 20 facilitators of implementation were identified related to guidelines; patients; health professionals; incentives and resources; capacity for organizational change; and social, political, and legal factors. The most prevalent barriers were related to incentives and resources, whereas the most prevalent facilitators were related to the capacity for organizational change. CONCLUSIONS: A number of barriers and facilitators were identified that could influence the implementation of digital mental health from the perspective of primary care decision makers. Implementers and nonimplementers identified many common barriers and facilitators, but they differ in terms of certain barriers and facilitators. Common and differing barriers and facilitators identified by implementers and nonimplementers may be important to address when planning for the implementation of digital mental health interventions. For instance, financial incentives and disincentives (eg, increased costs) are the most frequently mentioned barrier and facilitator, respectively, by nonimplementers, but not by implementers. One way to facilitate implementation could be to provide more information to nonimplementers about the actual costs related to the implementation of digital mental health.

An overview of the global antimicrobial resistance research and development hub and the current landscape.

Antimicrobial resistance (AMR) is an urgent public health threat, and continues to be on the rise. Basic microbiological research is the foundation for addressing knowledge gaps both for the development of new antibiotics, diagnostics and preventives but also to inform strategies to mitigate the transmission of resistance and drug resistant microorganisms. Translating this research into new products to reinvigorate dwindling pipelines, especially for new antibiotics, is one of the main challenges faced in addressing AMR. The scientific complexity is compounded by the market uncertainty of any new products leading to a large proportion of pharmaceutical companies exiting the market. Consequently, a number of initiatives were developed to reinvigorate the AMR research and development (R&D) landscape. Despite all these efforts, the antibiotic pipeline remains inadequate to keep up with the increasing rates of resistance globally. Given the number of individual and multilateral actions, there is an urgent need for a common platform and coordination to ensure that resources are adequately used to address the critical challenges posed by AMR globally hence the founding of the Global AMR R&D Hub to take on this role.

Antibiotic Pipeline Coordinators.

The World Health Organization (WHO) has published a global priority list of antibiotic-resistant bacteria to guide research and development (R&D) of new antibiotics. Every pathogen on this list requires R&D activity, but some are more attractive for private sector investments, as evidenced by the current antibacterial pipeline. A "pipeline coordinator" is a governmental/non-profit organization that closely tracks the antibacterial pipeline and actively supports R&D across all priority pathogens employing new financing tools.

Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations.

BACKGROUND: Antibiotic innovation has dwindled to dangerously low levels in the past 30 years. Since resistance continues to evolve, this innovation deficit can have perilous consequences on patients. A number of new incentives have been suggested to stimulate greater antibacterial drug innovation. To design effective solutions, a greater understanding is needed of actual antibiotic discovery and development costs and timelines. Small and medium-sized enterprises (SMEs) undertake most discovery and early phase development for antibiotics and other drugs. This paper attempts to gather a better understanding of SMEs' targets, costs, and durations related to discovery and early phase development of antibacterial therapies. METHODS: DRIVE-AB, a project focused on developing new economic incentives to stimulate antibacterial innovation, held a European stakeholder meeting in February 2015. All SMEs invited to this meeting (n = 44) were subsequently sent a survey to gather more data regarding their areas of activity, completed and expected development costs and timelines, and business models. RESULTS: Twenty-five companies responded to the survey. Respondents were primarily small companies each focusing on developing 1 to 3 new antibiotics, focused on pathogens of public health importance. Most have not yet completed any clinical trials. They have reported ranges of discovery and development out-of-pocket costs that appear to be less expensive than other studies of general pharmaceutical research and development (R&D) costs. The duration ranges reported for completing each phase of R&D are highly variable when compared to previously published general pharmaceutical innovation average durations. However, our sample population is small and may not be fully representative of all relevant antibiotic SMEs. CONCLUSIONS: The data collected by this study provide important insights and estimates about R&D in European SMEs focusing on antibiotics, which can be combined with other data to design incentives to stimulate antibacterial innovation. The variation implies that costs and durations are difficult to generalize due to the unique characteristics of each antibiotic project and depend on individual business strategies and circumstances.

Simulating Market Entry Rewards for Antibiotics Development.

We design an agent based Monte Carlo model of antibiotics research and development (R&D) to explore the effects of the policy intervention known as Market Entry Reward (MER) on the likelihood that an antibiotic entering pre-clinical development reaches the market. By means of sensitivity analysis we explore the interaction between the MER and four key parameters: projected net revenues, R&D costs, venture capitalists discount rates, and large pharmaceutical organizations' financial thresholds. We show that improving revenues may be more efficient than reducing costs, and thus confirm that this pull-based policy intervention effectively stimulates antibiotics R&D.

An assessment of the future impact of alternative technologies on antibiotics markets.

BACKGROUND: The increasing threat of antimicrobial resistance combined with the paucity of new classes of antibiotics represents a serious public health challenge. New treatment technologies could, in theory, have a significant impact on the future use of traditional antibiotics, be it by facilitating rational and responsible use or by product substitution in the existing antibiotics markets, including by reducing the incidence of bacterial infections through preventative approaches. The aim of this paper is to assess the potential of alternative technologies in reducing clinical use of and demand for antibiotics, and to briefly indicate which segments of the antibiotics market that might be impacted by these technologies. METHODS: An initial mapping exercise to identify the alternative technologies was followed by a review of relevant published and grey literature (n = 52). We also carried out stakeholder engagement activities by a round-table discussion with infectious disease specialists and a multi-criteria decision analysis exercise with pharmaceutical industry experts. RESULTS: Ten alternative technologies were identified and analyzed for their potential impact on the antibiotics market. Of these, rapid point-of-care diagnostics, vaccines, fecal microbiota transplantation, and probiotics were considered to have a "high" or "medium" potential impact over a 10-20 year horizon. Therapeutic antibodies, antibiotic biomaterials, bacteriophages, antimicrobial nanoparticles, antimicrobial peptides, and anti-virulence materials were rated as having "low" potential impact. CONCLUSION: Despite the apparent potential of the most promising alternative technologies to reduce demand, that reduction will likely only happen in limited segments of the antibiotics market or, in the case of preventing community acquired streptococcal infections by vaccination, in a low-price generics market segment. Thus, alternative technologies are not expected to represent any disincentive to antibiotics developers. Finally, it is unlikely that alternative technologies will displace the need for new classes, and sub-classes, of antibiotics in the short and medium terms.

Research funders' roles and perceived responsibilities in relation to the implementation of clinical research results: a multiple case study of Swedish research funders.

BACKGROUND: Implementation of clinical research results is challenging, yet the responsibility for implementation is seldom addressed. The process from research to the use of clinical research results in health care can be facilitated by research funders. In this paper, we report the roles of ten Swedish research funders in relation to implementation and their views on responsibilities in implementation. FINDINGS: Ten cases were studied and compared using semi-structured interviews. In addition, websites and key documents were reviewed. Eight facilitative roles for research funders in relation to the implementation of clinical research results were identified. Three of them were common for several funders: "Advocacy work," "Monitoring implementation outcomes," and "Dissemination of knowledge." Moreover, the research funders identified six different actors responsible for implementation, five of which belonged to the healthcare setting. Collective and organizational responsibilities were the most common forms of responsibilities among the identified actors responsible for implementation. CONCLUSIONS: The roles commonly identified by the Swedish funders, "Advocacy work," "Monitoring implementation outcomes," and "Dissemination of knowledge," seem feasible facilitative roles in relation to the implementation of clinical research results. However, many actors identified as responsible for implementation together with the fact that collective and organizational responsibilities were the most common forms of responsibilities entail a risk of implementation becoming no one's responsibility.