key: cord-0740962-danw91m4 authors: Negrini, Stefano; Mills, Jody-Anne; Arienti, Chiara; Kiekens, Carlotte; Cieza, Alarcos title: The “Rehabilitation Research Framework for COVID-19 patients” defined by Cochrane Rehabilitation and the World Health Organization Rehabilitation Programme date: 2021-03-11 journal: Arch Phys Med Rehabil DOI: 10.1016/j.apmr.2021.02.018 sha: 741dc3821d037a3f3601665402f8724fe91a7151 doc_id: 740962 cord_uid: danw91m4 The COVID-19 pandemic resulted in surge of research activity. Since its outset, efforts have been made to guide the rapid generation of research in medicine. There are gaps in some areas of rehabilitation research for patients with COVID-19. The development of a specific research framework might serve to help monitor the status of research (mapping), shape and strengthen research by pointing to under-investigated areas, and promote rehabilitation research in this context. This paper introduces and discusses the COVID-19 Rehabilitation Research Framework (CRRF) and presents the methodology used for its development. The questions have been developed among the World Health Organization Rehabilitation Programme, Cochrane Rehabilitation and the experts of its REH-COVER (Rehabilitation – COVID-19 Evidence-based Response) Action International Multiprofessional Steering Committee. The framework is divided into two parts and includes 20 questions organized in four groups: epidemiology, and evidence at the micro- (individual), meso- (health services) and macro- (health systems) level. The CRRF offers a comprehensive view of the research areas relevant to COVID-19 and rehabilitation that are necessary to inform best practice and ensure rehabilitation services and health systems can best serve the COVID-19 population. The collaboration between Cochrane Rehabilitation and the WHO Rehabilitation Programme in establishing the CRRF brought together perspectives from the health systems, health management and clinical evidence. The authors encourage researchers to use the CRRF when planning studies on rehabilitation in the context of COVID-19. The COVID-19 pandemic resulted in surge of research as the world sought to understand the disease and its prevention and treatment (1, 2) . The vast scale of the emergency and its immense health, social and economic accelerated research to an unprecedented pace (3); the availability of COVID-19 evidence expanded from observational studies in the early phases of the pandemic to clinical trials and systematic reviews in a matter of months (4) . However, the field of rehabilitation, which is highly relevant to the care of patients with COVID-19, has lagged behind during the emergency (5). Only limited high-quality evidence has emerged thus far compared to other medical fields (6, 7) . Of further concern are the persistent gaps in specific areas of rehabilitation research to guide clinical care and service organization for patients with COVID-19 (6, 7) . It is evident that both greater advocacy and support for rehabilitation research relating to COVID-19 are required, as well as stronger coordination to ensure that all areas of enquiry are addressed (8, 9) . Since the outset of the COVID-19 emergency, efforts have been made to guide the rapid generation of research, including through instruments such as the WHO Global Research Roadmap, COVID-19 Evidence Network to Support Decision-making (COVID-END) Network (10), and COVID-19 Research Coordination and Learning (COVID CIRCLE) partnership (11) . The focus of such initiatives, however, has been on slowing the spread of the virus and developing therapeutics and vaccines, leaving a chasm of direction for research related to the short and long-term impact of the virus on functioning, as well as rehabilitation interventions and services (12) . Cochrane Rehabilitation, the international body focusing on evidence dissemination (13) and growth (14, 15) (19, 20) and drive research efforts (21, 22) for entire sectors (23, 24) or specific topics and sub specializations, including in rehabilitation (25-28). Reflecting these traditional functions, the CRRF has the specific aims to: This paper presents the methodology used to develop the CRRF, discusses how emerging evidence maps to the CRRF, and proposes how it can be best operationalized to meet its intended aims. The CRRF was developed through a progressive consensus building approach between 5 and 26 June 2020. Defining of the first set of questions The process was based on a first set of questions developed by the first author (SN). This initial list was based on a document developed with the WHO-RP and Cochrane Rehabilitation for a previous project to map evidence on telemedicine. This version included three areas (evidence at micro- The list was revised in discussion with the authors, which resulted in an additional area (epidemiology), and in the addition of a series of other questions for existing areas. The updated list was disseminated using Survey Monkey online software. Participants included the 13 members of the International Multiprofessional Steering Committee (IMSC), which was convened by Cochrane Rehabilitation for the REH-COVER (Rehabilitation -COVID-19 Evidence-based Response) Action (Table 1) . Collectively, the IMSC represents eight professional areas of rehabilitation as well as an infectious diseases specialist, four WHO world regions, both high and low-middle income countries, and the WHO-RP. Participants were given seven days to respond, with one reminder sent. The survey instrument used closed binary answers, and free text boxes were provided for suggestions on each list items, as well as the overall framework. Participants were asked to report about missing areas and/or the redundancy of questions. The results were analyzed and discussed among the authors. Two new questions were added based on the feedback received. The final list of questions was synthesized and grouped by topic area. The list was then further divided into two thematic parts. This version was submitted to the IMSC for suggestions and eventual approval. Last fine tuning by the authors resulted in the CRRF presented here. The response rate to the first survey was 85%, while the final survey for refinement and approval achieved a response rate of 100%. The CRRF comprises of two parts. Part One, "Scope of rehabilitation research enquiry" ( Table 2 Part Two, "Areas of rehabilitation research enquiry and associated questions" (Table 3) , includes proposed questions, grouped as follows: The CRRF has already demonstrated its value in regard to its first aim, helping monitor the status of rehabilitation research for COVID-19 by enabling the mapping of emerging evidence to research categories. It has achieved this in the context of the work undertaken by, the REH-COVER Action, with the production of rapid living systematic reviews on rehabilitation and COVID-19 (6, 7), updated on a monthly basis (30-35) (Figure 1) , where the CRRF serves as the frameworks to classify each paper. A summary of the rapid living systematic review can be accessed at Cochrane Rehabilitation website (https://rehabilitation.cochrane.org/covid-19/reh-cover-rapid-living-systematic-reviews). The CRRF was also used to establish an interactive evidence map published in the Cochrane Rehabilitation website (36) (Figure 2 ), that is offered as a powerful tool to the rehabilitation community to identify and navigate the emerging evidence. The evidence mapping to the CRRF has revealed that, as of 31 October 2020, most research focuses on epidemiology, and there are almost no high-quality study designs on any of the CRRF questions (Table 4 ). For most of the questions at the micro, individual level, RCTs constitute the highest evidence level (37) . At the meso and macro levels (health services and systems levels, respectively), however, prospective observational (benchmarking) trials are the most feasible and appropriate (38) . Since it may take some time until we have high quality RCTs, we need to make sure that in the meantime knowledge and evidence are gathered with this kind of studies. Evidence coming from them will build knowledge useful to design RCTs. While the value of the CRRF towards aim one has already been demonstrated through its use by REH-COVER Action, in publishing the CRRF to a wider audience the authors intend to enable it to also achieve aims two and three. The first step to shaping rehabilitation research activity (aim two) is making researchers aware of the CRRF through this paper, while a dissemination effort by Cochrane Rehabilitation and WHO-RP through various media will extend its reach to the widest possible audience. The CRRF will continue to be used by the two bodies in the context of their work, promoting the framework among global scientific and professional societies within and beyond the rehabilitation community. For example, the continuing process of evidence mapping through the REH-COVER Action living rapid systematic reviews (6, 7) and their dissemination, will further increase awareness of the CRRF among researchers, and draw attention to areas requiring greater attention. This in turn plays an important role in driving planning and directing funding related to COVID-19 and rehabilitation research. The CRRF has important implications for research and contributes to improved clinical practice. Mapping research to the CRRF, as conducted by Cochrane Rehabilitation, makes apparent what research topics are well addressed and which are neglected. This helps to drive researcher efforts (21, 22) , and guides editors decisions. According to the current status of rehabilitation research (Table 3) (Table 1) , while the lines include the research questions of Part II of the CRRF (Table 2 ). In each resulting square, 4 circles represent the quality of evidence (one per color: Randomised Controlled Trial, non-Randomised Controlled Trial, analytical, descriptive studies) and the number of studies (the bigger the circle, the more the studies). Clicking on the circles, it is possible to "explode" the information and retrieve all single papers with related information. 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