Family Practice Vol. 19, No. 6, 691-697
© Oxford University Press 2002
A Research Information Sheet for Practices (RISP): a tool to facilitate research participation
General Practice & Primary Care Research, Institute of Public Health, University Forvie Site, Robinson Way, Cambridge CB2 2SR, UK; E-mail: HB208{at}medschl.cam.ac.uk
Bateman H. A Research Information Sheet for Practices (RISP): a tool to facilitate research participation. Family Practice 2002; 19: 691–697.
Received 17 December 2001; Accepted 16 July 2002.
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Abstract |
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Background. Practice teams may receive many requests to become involved in research studies. The information they receive may not necessarily provide the information they need to make a quick and informed decision about participation. Facilitating good decisions about research involvement has potential value for researchers, practitioners and research/development managers.
Objective. To develop and pilot a template (RISP) for communicating information about research studies to practice teams.
Methods. A participatory approach was used to develop the template involving primary care practitioners, researchers and research/development managers. The process of developing and piloting the template was recorded using an action research approach. Data were derived from documentation about policy, notes from participant observation and evaluation questionnaires.
Results. The RISP template was used as a source of reference about practical implications of research and as a means to communicate information about research studies to practice teams. Practice respondents valued its use in enabling members of the practice team to quickly assimilate information about the proposed research study and in providing the basis for a well-informed decision about participation. Its value to record keeping (and to research governance) was anticipated at the planning stage but was not as yet strongly evident in responses from practice.
Conclusion. The RISP template has been designed to reflect the concerns of researchers, primary care practitioners and research/development managers. It can contribute to the documentation required in support of research governance.
Keywords. Clinical protocols, family practice, patient selection, research design, Research Information Sheet for Practices.
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Introduction |
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Appropriate and successful management of recruitment is fundamental to high quality research. Low-response rates, unrepresentative recruitment, lack of adherence with the data collection process from recruited sites all represent potential threats to research quality and have a strong influence on effect sizes. However, from the practitioner point of view any research involvement represents a cost in terms of resources and the research process may have other implications (both favourable and unfavourable) for the practitioner and his/her patients.1 Practitioners must decide which of many potential studies are worthy of their support.2
Murphy et al. recommend that negotiations with partners/collaborators prior to involvement in research are essential.3 They describe the need for adequate information about the proposed research before practice representatives are asked to decide about practice participation and they emphasize that the focus of that information should be upon the practical implications of the research for those who would be involved in it.
Our own awareness of the gap which can exist between the specification of a research project and the practicalities of practice-based involvement was heightened when we were asked to comment on the feasibility of a proposed research study in terms of acceptability to local practices. The study was at an advanced stage of development. A pilot involving a small group of practices had already been successfully completed. The documentation about the project (in effect the ‘research proposal’) was detailed and clearly structured. However, despite a close reading of the detailed documentation we found ourselves unable to answer the question about ‘feasibility’ because the very practical details required to address the issue of practice involvement were not sufficiently covered.
As a result we set out to determine whether a standard template for a Research Information Sheet for Practices (RISP) designed to cover essential information about a research study would be welcomed by practitioners and, if so, what its content should be and what benefits it might offer. Subsequently we set out to test the template by monitoring its use and perceived value.
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Methods |
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In developing the RISP template we have taken an action research approach strongly influenced by the principles of participatory research.4,5 As such we have employed a variety of evaluation and recording mechanisms as appropriate in each stage of the development process. Data have been derived from documentation about policy, from prepared evaluation sheets and from notes following participant observation. Many practitioners already feel overburdened by requests for involvement in research6 and we therefore chose to make discriminate use of practitioner time as we negotiated the template. We identified opportunities to share our ideas and progress with practitioner and research colleagues often in conjunction with another activity (for example, as one item for discussion in a seminar about research involvement). Throughout these discussions we remained alert to any comments which might be indicative of benefits or reservations in what we were doing or which might affect the conclusions we were drawing. Where appropriate, benefits and reservations were incorporated within issues covered in the evaluation questionnaires.
Development
We discussed the RISP concept with various stakeholder groups who would be affected by its introduction; GPs active in developing their own research, GPs active in data collection for the research of others, academic researchers, academic research administrators, an NHS research manager, senior academics and representatives from primary care research networks. Following a universally positive response, we drafted a template for a research study information sheet which was then refined following further comments from researchers, practitioners in research active practices, a senior representative of local Primary Care Group and a GP with experience as a member of a Local Research Ethics Committee.
During the development phase we recorded the benefits that the RISP template was expected to offer (using documents about policy and comments from those involved in our discussions as our sources).
Piloting
Within the pilot stage we considered the perspectives of two groups; those who chose to make use of the RISP template (primarily researchers) and the practice representatives to whom a completed RISP template might be sent. Copies of the RISP template and guidance sheet were handed out widely to all researchers and contacts who expressed interest. Although the guidance sheet asked that those who subsequently chose to use RISP keep in contact with the originators for purposes of evaluation we cannot know the extent to which RISP is being used beyond the limited number of applications of which we are specifically aware.
The originator of the RISP template (HB) is also an advisor for those who are planning research in general practice but who are inexperienced as researchers or unfamiliar with the general practice setting. Three researchers asked for help from HB as they completed the RISP template. Notes were made of the issues raised within these discussions in order to better understand how the template might contribute in these circumstances.
Evaluation by those using the RISP template (primarily researchers).. Some individuals wished to use RISP for purposes other than that of directly informing practice teams about a research project. We noted the range of uses that they proposed and deliberately included this breadth of application within our evaluation questionnaire. Consequently this questionnaire included one question about the range of uses to which RISP had been applied and a second question incorporating more detailed consideration of its use and its value in communicating information about a research study. The second question asked respondents to express their agreement with various statements about the use of RISP. These statements were derived from an awareness of the anticipated benefits and from experience of working with researchers as they discussed or used RISP.
Evaluation by recipients of a completed RISP template (practice representatives).. The evaluation sent to those who had received a completed RISP template was one page long and included 3 questions about the value of RISP in presenting research study information. The evaluation questionnaire was sent as a follow-up to two different studies. These two studies had used RISP in communicating information about a new research study within the previous 6 months and were studies for which the researcher responsible had given specific agreement for this follow-up step. The first was a study involving two practices both of which had direct contact with the researcher. It involved a trial of a family based programme to increase exercise activity amongst individuals at high risk of diabetes. The second was a large study which aimed to recruit first incident cases of Parkinsonism with a view to establishing a first incidence figure and to improving recognition and management. For this study, an introductory letter and RISP sheet were sent to 107 practices in the Cambridgeshire and Huntingdonshire district. An evaluation questionnaire was sent to both practices in the first study and to a 25% sample in the second. One reminder letter was sent to practice representatives if no reply was received.
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Results |
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Development
The structure and layout of the RISP template which resulted from our discussions is shown in Figure 1
. Page 1 is intended to provide a brief overview of essential information about the proposed research project. Page 2 is intended to provide greater detail on the implications for the practice team and their patients.
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The completed template would be additional to any covering letter and/or personal contact planned with individual practices. (In addition, a one page guidance sheet was designed for researchers as an aid to completion.) The benefits expected, as derived from policy documents and stakeholder comments, are shown in Box 1
. | Box 1 Anticipated benefits through use of RISP For practitioners Potential benefits include: A succinct set of essential details to facilitate the practice team’s decision about participation. A structured reference document for any research study in which the practice might be involved.* Recognition of the requirement for a designated researcher contact (to facilitate ease of contact when needed). Useful documentation for individuals into the longer term to complement any personal professional development profile/portfolio. For research management Potential benefits include: Contribution to monitoring of research activity.* Explicit consideration of the feedback of research results to practitioners (a valuable principle to establish in the light of concerns about the implementation gap between research and practice8). Enables practices to build a structured, comprehensive record of their own research involvement (which could, for example, inform a practice team as it moves towards meeting the standards required for research practice accreditation via the Royal College of General Practitioners). Encourages good research practice in research recruitment by providing clear and complete information tailored to the needs of those whose participation in the research is sought. * Strong relationship to research governance requirements7
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Piloting
Nine individuals have reported using the RISP template. Eight used it as a source of reference about the essential information practitioners would need to know about a research project and rated the template as helpful in this context. Of these, six used RISP to communicate information about a research study of whom 4 rated the template very helpful and 2 of some help. Other reported uses for RISP included guidance for others about good practice in setting up research (4 respondents), a means to establish dialogue with practitioners about research (6 respondents) and a mechanism for capturing information about the implications for a practice of involvement in the activities of an outside agency, not necessarily research (4 respondents).
The six researchers who had used the RISP template in connection with an active research study were asked to indicate their level of agreement with various statements about its value and use. Three of these researchers were involved in a research study towards a higher degree, and three were involved in studies forming part of the academic department’s core research programme. All six researchers considered use of RISP to represent a good use of time. However, beyond this there was little consensus about where its particular value lay. Four found it helpful as a means to clarify their thoughts about the practical implications of the research study, and 3 as a means to modify the practical steps involved. Only one reported RISP as helpful in encouraging commitment to a specified process for feeding back research results to participating practices and only two reported that use of RISP had a discernible impact on the relationship established with practices.
The discussions with the adviser involving researchers inexperienced or unfamiliar with the general practice setting who were seeking the names of suitable patients for research participation raised three particular issues.
- Did the researcher need to seek involvement at the level of the practice team or at the level of the individual practitioner? This is not necessarily the straight forward question it might appear. (For example, two of the studies wanted a quota of patients from each practice but the identification of patients could only have taken place at the level of the individual practitioner.)
- How would the process operate within the practice? Two of the researchers saw their request as one which would be managed within the practice without the need for the researcher to specify any process. The need for the researcher to think in detail about how patients would be invited to participate in the study, by whom, using what approach and how the researcher would be kept informed had not necessarily been fully considered (although the particular requirements of the Local Ethical Committee had already been met in two of the three cases).
- How much involvement is it reasonable to expect from any practice in circumstances where little or no funding is available to cover practice costs? In two out of three cases no remuneration was available for the practice. However, the researchers were convinced of the value of their study to patient care. This in itself was considered a sound reason for practitioners to want to become involved. The time required to read detailed documentation or to attend a practice meeting about the research tended to be disregarded by researchers.
Two of the six researchers who had used the template in an active research study within the previous six months agreed to a follow-up evaluation about its perceived value. Twenty-nine practice representatives (primarily practice managers) who had been sent information within one or other of these research studies via a RISP sheet were sent a brief evaluation questionnaire (2 from the small two-practice study and 27 from the large across county study). Eighteen responses were received (2 from the small study and 16 from the large). Two respondents chose to complete and send (different) responses in the case of one practice. Eight respondents remembered seeing the original RISP information. Table 1 shows what the practice representatives who remembered seeing the RISP template felt about its use in presenting information about research.
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Practice respondents were asked to comment on the perceived value of RISP whether or not they remembered seeing the completed RISP template for the particular study concerned. The responses from the 18 who replied are shown in Table 2
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Discussion |
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The template was developed and piloted over a three year period using action research principles in a local setting based mainly on the research activities with which one university department was involved. The results reflect the small scale of the initiative. However, as we work towards transparent research governance, our experience in the development and use of the template may present important lessons, as follows.
The evaluation questionnaire sent to practice representatives was short and required less than 5 minutes to complete. Despite this the response rate was low—responses were received from 17 of 29 different practices (59%). Those contacted would appear to have either too little time or too little interest to respond to a short questionnaire which offered them the chance to influence the way in which they were contacted about research studies in future. This small task was far less arduous than the tasks that would be involved for the teams should they decide to participate in research (although one might argue that this questionnaire had no direct benefit to patient care and was therefore uniquely unappealing). As might perhaps have been anticipated, representatives from small practices (of one or two doctors) were less likely to respond than those from larger practices (P > 0.05). (Only 6 training practices were included in the sample, of which 5 responded.)
Practice teams cannot participate in all the requests for research to which they are exposed. They need to make choices. Good choices necessarily depend on adequate and appropriate information. Quick and effective assimilation of information is likely to be facilitated through the use of a consistent, and increasingly familiar, structure. Although the response rate was not high the practice representatives who did respond indicated that they considered it helpful to receive information about proposed studies in this structured format (Tables 1 and 2
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Use of the RISP template helped to establish a dialogue with researchers, inexperienced in general practice-based research, about the implications for a practice team of involvement in research. The value of this dialogue was endorsed by several GPs who have commented on the lack of recognition given to the practical implications of research studies. Researchers viewed the completion of the RISP template as worthwhile even though there was less agreement about where its particular contribution might lie.
Thirteen practice respondents felt that the RISP template would help the practice to keep records about the research studies with which they were involved whereas five said that they did not know. We do not know at this stage whether this is indicative of a problem with the template (not covering the information needed) or whether this is indicative of lack of engagement with the issue of record keeping about research. The importance of consistent and systematic record keeping will become increasingly important within the new frameworks for research governance9 and was recognized, at the planning stage, as an important consideration (see Box 1).
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Conclusion—towards research governance |
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The Research Governance Framework for Health and Social Care10 includes detailed discussions about the responsibilities held by key individuals within the research process. These key responsibilities include awareness of research activity in practice, its ethical approval and of the processes for informed consent and participation. Although the experience we report is only on a limited scale, there are indications that the RISP template may provide a useful tool for addressing these issues. It provides a structured means of documentation and explicitly defines the responsibilities for the researchers and for the practitioners involved in any particular research study. It also has an added advantage in that it has been derived with management, researcher and practitioner input into its design.
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Acknowledgments |
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The author thanks all her colleagues within and beyond the academic Unit who have helped to define and realize the RISP template. In particular, she thanks Tom Foltynie and Wendy Hardeman who allowed her to make follow-up contact with practices regarding their studies and to other researchers who allowed her to see and in some cases to comment on and adapt their research plans. Professor Ann Louise Kinmonth and Dr Mike Kirby (Director of HertNet) both kindly offered their advice on this paper and on the further implementation of RISP.
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References |
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1 Jones R, Murphy E, Crosland A. Primary care research ethics. Br J Gen Pract 1995; 45: 623–626.[Web of Science][Medline]
2 Moore M, Post K, Smith H. ‘Bin bag’ study: a survey of the research requests received by general practitioners and the primary health care team. Br J Gen Pract 1999; 49: 905–906.[Medline]
3 Murphy E, Spiegal N, Kinmonth A-L. ‘Will you help me with my research?’ Gaining access to primary care settings and subjects. Br J Gen Pract 1992; 42: 162–165.[Web of Science][Medline]
4 Stringer ET. Action Research: A Handbook for Practitioners. London: Sage, 1996.
5 Green LW, George MA, Daniel M, Frankish CJ, Herbert CJ, Bowie WR. Study of Participatory Research in Health Promotion: Review and Recommendations for the Development of Participatory Health Promotion in Canada. Ottawa: Royal Society of Canada, 1995.
6 Kaner EF, Haighton CA, McAvoy BR. ‘So much post, so busy with practice—so, no time!’: a telephone survey of general practitioners’ reasons for not participating in postal questionnaire surveys. Br J Gen Pract 1998; 48: 1067–1069.[Web of Science][Medline]
7 Department of Health. Research and Development for a First Class Service. London: Department of Health, 2000.
8 Department of Health. NHS R&D Strategic Review Primary Care Report of Topic Working Group. London: Department of Health, 1999.
9 Department of Health. Research Governance: Baseline Assessment for Research Active NHS Organisations. London: Department of Health, 2001.
10 Howe A. Interim advice from the RCGP Research Group on the Department of Health’s Research Governance Framework for Health and Social Care. London: Royal College of General Practitioners, 2001.
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