Collaborating with others is important at every stage in R&D, finding people who are interested in the topic you want to study and also who are experts in research methods.
Project design and planning
Collaborating with
others is important at every stage in R&D, finding people who are
interested in the topic you want to study and also who are experts in research
methods. Talking with colleagues and with other healthcare profes-sionals can
help to develop a broader perspective from initial ideas and allows input from
those with a track record in R&D. Collaborators might include academics at
a school of pharmacy or other health or social sciences discip-line. Advice can
also be sought from an organisation’s local NHS R&D office that can also
provide contact with a local forum for input from patients and the public.
Depending on whether the idea is research or service development, a local
clinical governance office can also be helpful.
As others become
involved, it is useful to establish early in the planning of the project the
extent of collaboration and the contribution they will provide; this is
particularly true for academic colleagues in terms of expectations around
co-authorship of published output.
Designing a robust
study is dependent on having a clear question to answer. The starting point may
be from interest in a particular area of research; this will need to be
channelled into a general, and then more specific, research question. The aim
is to arrive at a single question that is specific and as unambiguous as
possible. Then work to break down the question further and to develop
objectives for the study is required. For example, a team of researchers aiming
to reduce medication problems after discharge from hospital asked: ‘What is the
impact of a pharmacist-facilitated hospital discharge programme?’ and defined
their objectives as: ‘to characterise medication discrepancies at hospital
discharge and test the effects of a pharmacist intervention on healthcare
utilisation following discharge’.4 This example does not explicitly
state the outcomes that will be used other than the broad term ‘healthcare
utilisation’. Pharmacy practice research is now strengthening its use of
outcomes and there are still areas where exist-ing research is particularly
sparse, for example for clinical and economic outcomes.
Two issues are
raised for pharmacy because many of its interventions are as part of care
provided by a team: firstly, the need for multidisciplinary research to take
this into account and, secondly, not choosing outcomes where it would be
unlikely or even impossible for a pharmacy intervention alone to lead to
improved health outcomes. The Medical Research Council has produced guidance
for evaluating complex interventions that include conducting feasibility
studies to define interventions and outcomes.5 This framework could
be followed if the research asks complex questions com-paring pharmacist-led
services with usual care.
It is perhaps
helpful to consider an example. If the service were a hyper-tension clinic, a
feasibility study would define the processes in care and facilitate power
calculations to be undertaken to determine an appropriate sample size for a
randomised controlled trial that would demonstrate any likely impact on the
health outcome, in this case, blood pressure control. Process outcomes such as
patient satisfaction and acceptability of the service by other healthcare
professionals may provide positive outcomes but there may be no difference in
blood pressure control. Economic evaluation may be appropriate in such a study
to demonstrate that a change in service delivery is more efficient with no
detriment to patient care.
If the question is
more about why and how, then the outcomes will be more descriptive and
qualitative methods may provide the answers. If the question is what, then a
questionnaire may provide the answer. The challenge is to generate a question
that is not too ambitious and can clearly be answered. Once the question is
developed, before proceeding any further, there is a need to know if the work
has been done before.
Searching and
reviewing relevant literature will prevent reinventing the wheel and is a key
element in study design. Summarising what is known and not known from previous
work will help give a better understanding of both the context and issues in
the chosen topic. It is then possible to build upon existing published evidence
and make a useful and relevant contribution. Depending on the strength of the
researcher’s skills in con-structing an electronic literature search,
assistance from the medicines information team or from a medical librarian can
be key at this stage. As for clinical evidence, the principles of information
mastery apply, drilling down through a hierarchy of sources beginning with
systematic reviews and moving through to individual studies.6 A
useful starting point might be the Cochrane Collaboration on effective professional
practice. Learning resources available through the UK Medicines Information
web-site (www.ukmi.nhs.uk) may help with your search strategy and provide
examples of research in medicines information. It is important to remember that
there are many published abstracts from pharmacy conferences, such as the
British Pharmaceutical Conference, Health Services Research and Pharmacy
Practice Research Conference and UK Clinical Pharmacy Association (UKCPA)
conference. These can usually found at the relevant website and are a valuable
source because not all of these make their way into the wider literature if
they are not subse-quently written up as full papers. Local NHS R&D and
clinical gover-nance offices may also hold local and national databases of R&D
projects. An advanced Google search can also be useful. Accessing full copies
of published papers may be possible through the organisation’s clinical library
or medicines information team.
The literature
review must go beyond being descriptive to being critical, showing an
understanding of the strengths and limitations of the studies being appraised.
Results and conclusions need to be assessed in the light of the research design
used and the appropriateness of the methods to answer the question posed.
Finding out whether
key authors in the relevant field have ongoing studies that are due to be
published is another important step. Most researchers are happy to be contacted
and there may even be the possibility for collaboration. Papers in peer-review
journals almost always have address and e-mail contact details for the
corresponding author; otherwise ‘googling’ by name and organ-isation is usually
fruitful.
Depending on the
question and the outcomes to be measured, an experimental or descriptive
approach or a mixture of the two may be selected; quantitative or qualitative
methods, or both, may be appropriate. Experimental studies are used to test the
effects of an intervention and they aim to investigate causes and associations.
Experimental research designs include ‘true’ experiments (randomised trials)
and quasiexperimental studies. Their aim can be ‘proof of concept’ or ‘proof of
generalisability’. Choosing the appropriate method/s is a balance between
selecting the ideal design (highest validity) with the most practical (highest
feasibility).
Both quantitative
and qualitative methods are used in pharmacy practice research. In the former
the data are numbers and measurements, and in the latter narrative descriptions
and observations. Qualitative methods are valu-able in stand-alone studies and
also have an important role in setting content for quantitative methods,
including surveys. Survey studies are commonly used; they collect information
in a standardised form from groups of people and are useful providing the
questions have been framed. They usually employ questionnaires or highly
structured interviews to obtain a small amount of data from a large population.
Self-completed questionnaires are efficient in terms of researchers’ time and
effort. Closed questions will provide more concise replies, but wording needs
to be carefully developed and tested. Rating scales are often used to collect
data in questionnaires, for example, strength of agreement or disagreement
about statements. Open questions generate qual-itative data that can be
subjected to a content analysis. Coding of content can be used to produce a
quantitative profile of responses that can be supplemented by illustrative
quotations; this is a time-consuming process requiring consid-erable skill.
Semistructured interviews are a key tool in qualitative research and enable
rich and in-depth information to be collected. Focus groups use a topic guide
and facilitated discussion to cover the topics. The Delphi and nominal group
techniques are used in specialist areas of practice to obtain consensus, but
again can be time-consuming. To choose the best methodology or tool, other
research in the topic can be examined as a guide; there may even be a validated
tool that would be ideal for the planned research.
Consideration must
be given to the study population, how many subjects are required and how they
will be recruited. The inclusion and exclusion criteria will need to be
established to help arrive at participants who will help answer the question
posed. For a quantitative study a sample size or power calculation will be
necessary, checking to see the study has sufficient partici-pants to give an
answer that is not merely down to chance. If there is no statistical expertise
in the team, the NHS R&D office should be able to help. It is also a good
idea to consider how the data will be analysed and to obtain statistical advice
at an early stage. This may also help design the data collec-tion tools. A
decision on who will measure the outcomes will need to be made. Depending on
the intervention, it may be more appropriate to engage an independent
researcher such as a research nurse to administer questionnaires or take
clinical measurements. The local R&D office or clinical research facility
may be able to help.
It is a good idea at
this stage to develop a study protocol outlining the project as this provides a
focus for collaborators to provide feedback and it will be required for
approval processes. It will also help to clarify whether or not they will be
part of the project team. A more detailed protocol will need to be developed as
plans progress. There is no set outline for a research protocol and funding
bodies may specify their own template, but the following head-ings would
usually be expected
·
title of the study
·
study team and contribution of individual members
·
summary of aims, objectives, methods and outcomes to be
measured background: this section justifies the need to undertake the research
based on the literature review and any pilot work done
o
aims and objectives
o
study design and methods:
o
setting where the research will take place
o
subjects/patients, including how they will be identified and
recruited, and inclusion and exclusion criteria. The sample size must be
justified and, for a quantitative study, say whether a sample size calculation
has been used
o
methods of assessment or measurement: explain what data will
be collected, data collection instruments to be used and why they were chosen.
If equipment needs to be used, describe it, and how its measures will be used
o
outcome measures need to be stated for both quantitative and
qualitative studies
o
interventions (if applicable): if the study involves an
intervention, it should be described. If giving a treatment or investigation,
the dose, timing, method of providing, administering and receiving the
treatment should be detailed. All necessary safeguards and potential risks
should be made clear, including the methods by which intervention will be
monitored
·
data collection, management and analysis, including how data
will be collected, method of data entry, plan of analysis, and any data
analysis packages
·
ethical considerations
·
benefits of the research to patients and the NHS
·
costs, including staff salaries, equipment, running costs (for
example stationery, telephone, postage, travel) and any overheads (such as
costs for office space, lighting, heating)
·
timescales
·
references
·
appendices (draft or actual data collection forms,
questionnaires, interview schedules)
·
which approvals are needed for my study?
The main aim of
research governance is to ensure all NHS researchers comply with a framework of
activities and minimum standards and to be able to demonstrate their research
quality through defined audit trails. There are two main types of NHS approval
for research studies: (1) research ethics; and (2) R&D management approval.
If the study is going to involve patients or staff working within the NHS,
advice must be sought on whether ethical and local R&D approval is needed.
This hinges on whether the project is considered to be ‘research’, hence the
importance of the earlier definitions. The local R&D office will be able to
advise on this as well as on local procedures that may be required for audit or
service evaluation, which are sometimes overseen by clinical effectiveness
teams. The electronic Integrated Research Application System ethics form (www.
myresearchproject.org.uk/) gives an idea of the issues for consideration.
Projects which are not ‘research’ will probably require approval through
clinical governance structures. Irrespective of whether the study is deemed
‘research’ or ‘audit’, Caldicott principles, patient consent and data
protection should be considered, though the project design will determine if
particular actions are required. Training programmes may be available through
the local NHS R&D office or through partner academic institution.
Regardless of
whether the study is self-funded or an application for funding is to be made,
it is important to understand the resources that will be needed, including
time, equipment, consumables, travel and dissemination costs. These need to be
clear on all approval forms and the local NHS R&D office may be able to
help with templates for estimating and costing resources. The National
Institute for Health Research is a major funder of health research
(www.rdinfo.org.uk; http//rdfunding.org.uk) and has several funding streams,
some of which are commissioned on specific topics and some are responsive and
intended to meet needs identified within the service. There are many other
possible sources of funding, such as www. cso.scot.nhs.uk (in NHS Scotland) and
many clinical specialist charities. Any bid needs to be targeted appropriately
to the relevant body. Some pharmacy organisations have awards to support pilot
or development work and small projects, and these are valuable to test out
ideas if you are thinking of applying for funding for a larger study. It is
important that the proposal has been well reviewed by all members of the
project team before it is submitted for funding or approval.
An example of how a
research programme was developed from the starting point of an audit of care is
shown in Text box 16.1.
Starting
from audits of care in patients who had had a stroke, an application was made
for a research grant to:
•
explore beliefs and concerns about medicines
•
identify the difficulties experienced taking medicines
•
design documentation incorporating the evidence base and pharmaceutical needs
as identified by patients and carers.
The
application was successful and the study was conducted with 30 patients who
were purposively sampled and had been discharged after stroke or transient
ischaemic attack within the past 12 months. Semistructured interviews covered
self-reported adherence with prescribed medication and patients were asked to
complete the Beliefs about Medicines questionnaire. The medicine-related
problems identified were then addressed. The draft document produced as a
result was reviewed by patients, general practitioners, community pharmacists
and the local stroke managed clinical network.
Using
the results from the study a further grant application was made to conduct a
randomised exploratory trial of a pharmacist-led home-based clinical medication
review in people after stroke. The purpose of this study was to conduct an
exploratory trial to define the intervention, outcome measures and sample size.
Pharmacist-led home-based clinical medication review at 1 and 3 months after
discharge (n = 20) is being compared with ‘usual care’ (n ¼ 20), and 6- month
follow-up which ended in May 2010. Further grant application has been made to
test the feasibility of recruitment from primary care and to include telephone
interview.
The research is a collaboration between pharmacy, geriatric medicine, community health sciences, psychology and the Stroke Research Group.
Much greater
emphasis is now placed on dissemination than used to be the case. Effective
dissemination of results to those who need to take action is now widely
recognised as an essential part of the research process. In the past there has
been more emphasis on academic methods of dissemination so that infor-mation is
publicly available and open to peer review. This has changed to incorporate
dissemination to key stakeholders because ultimately R&D activ-ities are
done with a view to change and improvement. This can only happen if the
findings are acted upon. Research can be disseminated in many ways, including
full original peer-reviewed journal publications, articles in profes-sional
journals, oral and poster conference presentations, newsletters, reports,
briefings and entries in research databases. A dissemination plan should be
agreed by the project team at the outset of the study, as there may be
differ-ences in opinion as to where research should be published. Guidance on
preparing and presenting research is available from various pharmacy
organ-isations. For example the UKCPA, UK Medicines Information and European
Society of Clinical Pharmacy include guidance on preparation of abstracts and
posters on their websites (http://www.ukcpa.org.uk; www.ukmi.nhs.uk;
www.escpweb.org). Abstracts from posters and presentations at previous pharmacy
conferences (for example, British Pharmaceutical Conference, Health Services
Research and Pharmacy Practice Research Conference and UKCPA conference) can
usually be found on their websites. It may be possible to present findings at
both pharmacy conferences and at multidisciplinary specialist conferences such
as Diabetes UK.
Publications are
rewarding for researchers and raise not only their indi-vidual profile but also
the profile of the profession in a multidisciplinary environment. Proactive
dissemination to stakeholders is an important part of the overall strategy and
requires creative thinking. A strategy might include targeted presentations to
relevant boards or committees, written briefings sent to a targeted audience
and multi-stakeholder workshops at which find-ings can be discussed and actions
needed prioritised. Again collaboration is helpful, whether it is academic
support for writing for peer-review journals and conferences, or review of
briefings and articles by some of the intended audience.
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