Public-private knowledge transfer and access to medicines: a systematic review and qualitative study of perceptions and roles of scientists involved in HPV vaccine research.

BACKGROUND: Public research organizations and their interactions with industry partners play a crucial role for public health and access to medicines. The development and commercialization of the Human Papillomavirus (HPV) vaccines illustrate how licensing practices of public research organizations can contribute to high prices of the resulting product and affect accessibility to vulnerable populations. Efforts by the international community to improve access to medicines have recognised this issue and promote the public health-sensitive management of research conducted by public research organizations. This paper explores: how medical knowledge is exchanged between public and private actors; what role inventor scientists play in this process; and how they view the implementation of public health-sensitive knowledge exchange strategies. METHODS: We conducted a systematic qualitative literature review on medical knowledge exchange and qualitative interviews with a purposive sample of public sector scientists working on HPV vaccines. We explored the strategies by which knowledge is exchanged across institutional boundaries, how these strategies are negotiated, and the views of scientists regarding public health-sensitive knowledge exchange. RESULTS: We included 13 studies in the systematic review and conducted seven semi-structured interviews with high-ranking scientists. The main avenues of public-private medical knowledge exchange were publications, formal transfer of patented knowledge, problem-specific exchanges such as service agreements, informal exchanges and collaborative research. Scientists played a crucial role in these processes but appeared to be sceptical of public health-sensitive knowledge exchange strategies, as these were believed to deter corporate interest in the development of new medicines and thus risk the translation of the scientists' research. CONCLUSION: Medical scientists at public research institutions play a key role in the exchange of knowledge they generate and are concerned about the accessibility of medicines resulting from their research. Their scepticism towards implementing public health-sensitive knowledge management strategies appears to be based on a biased understanding of the costs and risks involved in drug development and a perceived lack of alternatives to private engagement. Scientists could be encouraged to exchange knowledge in a public health-sensitive manner through not-for-profit drug development mechanisms, education on industry engagement, and stronger institutional and legal backing.

[Assessment of the severity of postoperative complications from the patient and doctor perspective]. / Einschätzung des Schweregrads postoperativer Komplikationen aus der Sicht von Patienten und Ärzten.

AIM OF THE STUDY: This study compares doctors' and patients' assessments of the severity of postoperative complications reported by patients. Within the context of quality assurance and patient safety, the study aims to contribute to developing instruments to include patients' views for measuring postoperative complications. METHODS: In a questionnaire development study 474 patients who had undergone different kinds of surgery were given a questionnaire and asked whether postoperative complications occurred, and if so, to describe these complications in free text and assesses their severity as "slight, temporary" or "extensive". In an additional study, the patients' written descriptions of their complications were presented independently to two doctors (general practitioner [GP], orthopaedic surgeon) who were asked to assess the severity from their point of view. The physicians were not aware of the patients' or the other physician's assessments. RESULTS: 23.5 % of the patients participating in the survey reported postoperative complications in the questionnaire. Feedback from 80 of these patients included sufficient information for data analysis concerning the study's aim, including the description of their complication in free text. 47 (58.7 %) of these patients assessed their postoperative complications as being "slight, temporary", 33 (41.3 %) as being "extensive". The doctors, on the other hand, assessed the severity of the complications described by the patients much less often as "extensive" (GP: 20.0 %, orthopaedic surgeon: 11.3 %). In only 4 (12.0 %) of the 33 cases where the patient chose "extensive" both doctors also chose the assessment item "extensive". In 10 cases (30.3 %), one doctor's "extensive" assessment matched the patient's assessment, and in 19 cases (57.6 %) the patients but none of the doctors assessed the complications as being "extensive". There was a higher correlation between the GP's and the patients' assessments than between the orthopaedic surgeon's and the patients' ratings. Examples of patients' descriptions of their postoperative complications in free text as well as the corresponding assessments of patients and doctors are presented. CONCLUSIONS: Patients' views and assessments of postoperative complications are different from doctors' views. Adequate instruments for measuring the occurrence and severity of postoperative complications should be developed bringing the patients' perspectives into the doctors' assessments. Also, it might be useful to include questions addressing information received pre- and postoperatively about the expected postoperative course as well as communication with patients in the case of complications.

An Architecture for the Integration of Clinical Data from a PEHR in a Regional Research Platform.

Making clinical information available for research is not only relevant for healthcare institutions, but also for regional EHRs, as cross-sectorial information can be made accessible. In the INFOPAT (INFOrmation technology for PATient-oriented health care in the Rhine-Neckar metropolitan region) project we are thus implementing both, a regional personal cross-enterprise electronic health record (PEHR) and a regional research platform (RRP) based on information from the PEHR. IHE profiles are implemented to achieve interoperability between healthcare institutions electronic medical records (EMR) and PEHR on the one hand, as well as PEHR and RRP on the other hand. The use case for the RRP is cross-sectorial quality assessment and improvement for colorectal cancer based on a quality indicator (QI) approach including patients' perspectives. For semantic interoperability the responses are transferred in the form of HL7 CDA L2 documents. The resulting architecture for a RRP shows that implementing a PEHR in combination with a RRP based on international communication standards is possible. Also IHE XDS can be used for integration of patient care and biomedical research infrastructures.