[Opportunities and challenges of active patient involvement in clinical research in Germany - from the perspectives of a patient representative, a clinical researcher and two staff members of research funding management]. / Chancen und Herausforderungen der aktiven Beteiligung von Patient*innen an klinischer Forschung in Deutschland ­ Eine Betrachtung aus den Perspektiven eines Patient*innenvertreters, einer klinischen Forscherin und zweier Mitarbeiterinnen des Forschungsfördermanagements.

BACKGROUND: Active involvement of patients in clinical research is increasingly demanded in Germany. It has great potential to increase the quality and relevance of research and to contribute to patient empowerment. However, patients, researchers and research funders have experienced that the implementation of patient involvement is accompanied by cultural, practical and personal challenges. The aim of this article is to discuss the opportunities and challenges of patient involvement in Germany from the perspective of the stakeholders involved. METHOD: A patient representative, a clinical researcher and two staff members from research funding management were invited to discuss the opportunities and challenges of patient involvement. Their perspectives were recorded in two written open survey rounds. The answers were analyzed using qualitative content analysis. RESULT: In the opinion of the stakeholders involved, the increasing involvement of patients in clinical research is an opportunity to promote the practical relevance of research and the implementation of studies, to increase their acceptance by the target group and to improve the uptake of research results in practice. However, the implementation of patient involvement was also perceived as challenging. They described problems with regard to the acquisition and selection of patients, the training of the patients and the specifications and support structures for the implementation of patient involvement. DISCUSSION: While patient involvement in clinical research offers great potential, the development of appropriate structures and framework conditions for its implementation is still virtually unestablished in Germany. This needs to include, among other things, creating a broader awareness of the potential of patient involvement, developing training programs for patients and researchers, providing sufficient, mainly project-independent resources and ensuring regular evaluations.

[Patient and public involvement in clinical research: An introduction]. / Aktive Beteiligung von Patient*innen an klinischer Forschung ­ Eine Einführung.

Usually, patients participating in clinical trials have a passive role as test persons. This creates a risk that patients' needs and interests are not reflected in clinical research. The aim of the present paper is to give an introduction to patient involvement in clinical research. It is based on an exploratory literature research and our own experiences with patient involvement. By actively involving patients in the design, conduct and translation of clinical trials, research and healthcare can be better tailored to meet the patients' needs. Patient involvement has the potential to enhance the quality and relevance of research, support patient empowerment and contribute to the democratisation of research processes. There are different methods to involve patients in research, which are often differentiated as consultation, cooperation and user-led research. Methods, time of involvement and persons to be involved should be chosen to fit the aims of the involvement. While cultural, practical and personal barriers could hinder patient involvement, there are several strategies that enable effective involvement: defining the aims of the involvement, clarifying motivation and expectations as well as roles and the form of cooperation, offering training, planning sufficient resources, involving patients from the start and communicating the benefits of involvement.

[Older patients' involvement in research (INVOLVE-Clin): a study protocol]. / Aktive Beteiligung von älteren Patient*innen an klinischer Forschung (INVOLVE-Clin): Ein Studienprotokoll.

INTRODUCTION: Patient involvement in health research is an integral part of health care in many countries. It promotes the relevance and quality of research and increases the meaningfulness of research results. Meanwhile, the value of patient involvement has also been recognised in Germany. The lack of a common understanding of patient involvement and appropriate methods make implementation difficult. In Germany, patients are still rarely involved in the planning and conduct of health research. Vulnerable patient groups such as the elderly and the very old are considered particularly challenging for researchers in active patient involvement due to their special needs, which is why they are often neglected. Especially nursing home residents suffer from a variety of health impairments which are accompanied by a high number of prescription drugs and adverse events and can therefore make patient involvement more difficult. The present project aims to test the method of patient advisory boards for the involvement of nursing home residents. Using the design of a clinical trial to optimise medication for nursing home residents as a case study, we will assess the feasibility of the method for this target group. We will also install a patient advocate as moderator of the advisory board. The study plan is described in the present study protocol. METHODS: Two patient advisory boards with nursing home residents will be established. With a patient advocate acting as moderator, the essential elements of a clinical trial to optimise medication will be discussed and passed on to the study planning team via the patient advocate. The overall topic of the clinical trial is the optimisation of medication in cardiovascular disease. The nursing home residents are informed about the contents and ideas of the study to be planned and the interests of the researchers, respectively, and will discuss the proposals of the study planning team. Nursing home residents', the patient advocate's and the researchers' expectations and experiences will be examined in individual interviews. DISCUSSION: The study will provide a potentially suitable method to involve nursing home residents in the research process. The jointly developed study design will be incorporated into a new project proposal. The results will be used to inform the development of a German handbook on active public and patient involvement.

[Assessing the Benefit of Palliative Care in Germany - Perspective of Patients, Relatives and Professionals]. / Den Nutzen von Palliativversorgung bewerten ­ Was muss aus Patienten-, Angehörigen- und Versorgersicht beachtet werden?

BACKGROUND: The evaluation of complex interventions such as palliative care is challenging. Methods guidance such as the guidance documents of the Integrated Health Technology Assessment for the Evaluation of Complex Technologies (INTEGRATE-HTA) project help address specific challenges. The INTEGRATE-guidance was developed cooperatively by various international stakeholders and it was applied in a case study on palliative care. The presented study was part of the INTEGRATE-HTA project. ObjectivesThe objective was to identify important assessment aspects of palliative care in Germany from the perspective of patients, relatives and professional providers. METHODS: Applying the structured consensus method of the Improved Nominal Group Technique, we conducted interviews with two focus groups - one with relatives and one with professionals. Additionally, we conducted 4 interviews with patients. We used an open coding procedure to analyze the data and a dialogical approach to validate the results. RESULTS: 8 assessment aspects were found to be important. These are the definition and legitimacy of the term benefit, understanding of palliative care, patient-centered and holistic care approach, access to palliative care, continuity and flexibility of care, education of palliative care providers, and multidisciplinary approach. A central point was the need to address the intervention in its complexity and to include interactions between the different components. CONCLUSIONS: To be able to integrate various models and different perspectives of palliative care, it is important to have the involvement of different stakeholders. This also enhances the incorporation of important aspects during the development of assessment instruments.

Patients' and researchers' experiences with a patient board for a clinical trial on urinary tract infections.

BACKGROUND: Patient and public involvement (PPI) has become an essential part of the design, conduct, and dissemination of research. While researchers who employed PPI mainly report on the positive aspects, in practice PPI is still an exception in clinical trials in Germany. There are specific challenges in the process of involvement that can jeopardize the conduct of involvement. The aim of our study was to analyze the experience of patients and researchers with PPI in a clinical trial in Germany, so we could learn more about potential challenges and how they could be addressed. METHODS: We established a patient board for a randomized controlled trial on urinary tract infections, where patients and researchers regularly met to discuss relevant aspects of the trial. Minutes were taken for each meeting and the moderator also noted her observations in a postscript. After four meetings, we conducted two focus groups, one each with the patients and researchers. We analyzed and categorized the minutes, postscripts, and focus group transcripts using thematic qualitative text analysis. RESULTS: Patients and researchers felt comfortable with the composition of the patient board and its' atmosphere. In terms of challenges, patients and researchers needed time to get familiar with PPI. Both parties saw a need for training in PPI but differed in their views on the relevant topics. Patients wished to learn more about their role and tasks within the board at the onset of the PPI. They also preferred to meet more frequently and get more intensely involved in the trial. In contrast, researchers perceived that they were already highly involved. They further felt that the involvement was of benefit to them, the trial and future research. Patients described benefits for themselves, but also wondered if their involvement had had an impact on the trial. CONCLUSIONS: To facilitate effective PPI, resources, adequate structures, and training are needed. Patients and researchers need to agree on their respective roles, training needs, and the mode of cooperation right at the beginning. The parties involved should continuously reflect on the actual benefits of PPI, describe them explicitly and make them transparent for all.

Patient involvement in clinical trials: motivation and expectations differ between patients and researchers involved in a trial on urinary tract infections.

PLAIN ENGLISH SUMMARY: Patients should be involved in the design, conduct and dissemination of research that affects them. Patient involvement leads to empowerment and enhances the quality of research. Differing motives and expectations between researchers and patients involved can hamper involvement. We wanted to learn more about patients' and researchers' motives and expectations in order to improve the benefits of involvement for all parties. We implemented a patient board with ten patients and five researchers for a trial on urinary tract infections (UTIs). We asked each patient and researcher about his or her motivation and expectations regarding the patient board. We found that patients' motivations included the wish to improve the treatment of UTIs, to support patient involvement as a principle, and to enhance the benefit of others. Furthermore they were interested in learning how a patients' board works and in exchanging with peers and scientists. In addition, a (modest) monetary incentive for involvement was welcomed.Researchers were motivated by the possibility to improve research and to contribute to the empowerment of patients. They also wanted to enhance their career opportunities, to learn more about patient involvement and to meet the increasing demand for it. Some patients expressed insecurity about their roles and tasks in the patient board. Among the researchers, some envisaged a rather passive role for themselves in the patient board while others expected to take over a more active role. Researchers emphasized that the ways and the means of communication between the researchers and the patients should be explicitly discussed. ABSTRACT: Background It has been increasingly recognized that patients should be actively involved in the design, conduct and dissemination of research. Besides empowering patients and democratizing research, involvement can enhance the quality of research and the development of equitable healthcare solutions. Differing motives and expectations between researchers and involved patients can hamper the conduct of involvement. However, little is known about patients' and researchers' motivations for involvement. Our aim was to study the motivation and expectations of patients and researchers towards patient and public involvement (PPI). Methods We implemented a patient board comprising ten patients and five researchers for a randomized controlled trial on the treatment of urinary tract infections (UTI). Prior to the first board meeting, we conducted telephone interviews with all researchers and patients regarding their motivation for involvement in the patient board and their expectations. The interviews were analyzed using thematic qualitative text analysis. Results Patients' motivations included interest in improving UTI treatment, in supporting PPI, engaging for the benefit of others, exchanging with peers and scientists as well as in the methods of the board and the monetary incentive. Researchers wanted to improve research, enhance their professional development, empower patients, meet the formal demand for PPI, and learn about PPI. Regarding expectations, patients expressed insecurities about their roles, tasks and topics of discussion. They wished for an open exchange and hoped their involvement would make an impact. Researchers' expectations for their own roles ranged between being a rather passive supporting force and active engagement in the board. The question of how to ensure the communication between the trial team and the patient board was of high importance for the researchers. Conclusions Patients' and researchers' motives and expectations were similar in some aspects but differed regarding agenda setting and understanding of their roles. Getting to know patients' and researchers' motivations and expectations at the beginning allowed us to anticipate potential conflicts or disappointments early on and to take them into consideration during the conduct of our PPI.

Methods for Involving Older People in Health Research-A Review of the Literature.

Demographic change has increased the need for research on healthcare for older people. Recently there has been a growing awareness that research might benefit from actively involving patients and the public in study design and conduct. Besides empowering patients and democratizing research, involvement enhances the quality of research and the development of equitable healthcare solutions. Little is known about how to involve older people. This review aims to support scientists intending to involve older people in health research by systematically identifying and describing studies involving older people and analyzing associated facilitators and challenges. Old people were operationalized as people living with old-age-related conditions. We conducted a systematic search in PubMed, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and Cochrane library for the period 2007 to July 2017 and also manually searched reference lists of the nine retrieved articles and other relevant sources. While involvement of older people in research is feasible, specific challenges related to this group need be taken into account. Strategies to enhance effective involvement comprise a thoughtful choice of location, use of visualization and accessible communication, building good relationships and flexible approaches. Further research is needed on the involvement of people in care homes or with vision, hearing or mobility limitations.

AN INTEGRATED PERSPECTIVE ON THE ASSESSMENT OF TECHNOLOGIES: INTEGRATE-HTA.

OBJECTIVES: Current health technology assessment (HTA) is not well equipped to assess complex technologies as insufficient attention is being paid to the diversity in patient characteristics and preferences, context, and implementation. Strategies to integrate these and several other aspects, such as ethical considerations, in a comprehensive assessment are missing. The aim of the European research project INTEGRATE-HTA was to develop a model for an integrated HTA of complex technologies. METHODS: A multi-method, four-stage approach guided the development of the INTEGRATE-HTA Model: (i) definition of the different dimensions of information to be integrated, (ii) literature review of existing methods for integration, (iii) adjustment of concepts and methods for assessing distinct aspects of complex technologies in the frame of an integrated process, and (iv) application of the model in a case study and subsequent revisions. RESULTS: The INTEGRATE-HTA Model consists of five steps, each involving stakeholders: (i) definition of the technology and the objective of the HTA; (ii) development of a logic model to provide a structured overview of the technology and the system in which it is embedded; (iii) evidence assessment on effectiveness, economic, ethical, legal, and socio-cultural aspects, taking variability of participants, context, implementation issues, and their interactions into account; (iv) populating the logic model with the data generated in step 3; (v) structured process of decision-making. CONCLUSIONS: The INTEGRATE-HTA Model provides a structured process for integrated HTAs of complex technologies. Stakeholder involvement in all steps is essential as a means of ensuring relevance and meaningful interpretation of the evidence.