Taking the First Steps
Prof. Dave Brown, Head of Pharmacy Practice School of Pharmacy
and Biomedical Sciences, University of Portsmouth helps you to
take those important first steps.
 Introduction
Why Do Research?
Getting Ideas!
Things to Think About Early!
Aims, Objectives and Hypotheses
The Research Process and Planning
The Research Protocol
Writing a Funding Proposal
Bibliography
Introduction
'Nobody's perfect' - we could all improve our practice 'somewhere, somehow,
somewhen'. How often have you wondered:
what would happen if……?
why did that occur …….?
how could I change this ………?
when would be the most effective time to ……..?
As MI pharmacists, we are already attuned to the huge amount of published
research available at our fingertips. We often participate, sometimes unwittingly,
in other people's research projects by providing information from literature
searches on for example, clinical trial outcomes, drug interactions, adverse
events or pharmacoeconomics. Most of us can also evaluate and present the
results of other people's research in an unbiased, clear and helpful way.
Pharmacy practice research seeks to understand pharmacy and the way it is
practised to ensure that the pharmacist's knowledge and skills are being used to
best effect in solving NHS problems and addressing the health needs of patients.
It is applied research, often multidisciplinary in nature, and draws on the social,
psychological and economic sciences; both quantitative and qualitative techniques
are employed.
It seeks to provide useful solutions to practical problems: the best research is
always useful to somebody!
Remember that the results from your research might be used to instigate
changes in practice that might have a profound effect on patient care and its cost.
Therefore it is vital that the research is based on sound methodology and carried
out competently. It should be based on the cornerstones of consistency, honesty,
diligence and patience - what professors of pharmacy practice might call
'academic rigour'!
Sooner or later we are likely to get involved more deeply in a research project,
perhaps as a collaborator with other healthcare colleagues or in generating an
evidence base on which to develop our own practice. Many of us have already
had some experience of research design, either at undergraduate and possibly
postgraduate level. Some of us may be involved with a research project at this
very moment.
Whatever your level of research experience - whether you support the research of
others, are an active researcher or would like to become one - there a few basic
concepts that are common to all good research. These are discussed in the
following pages.
Why Do Research?
The diagram below shows some common factors that may give birth to a project.
These can range from personal reasons - achieving something out of the ordinary
or gaining recognition in the form of a higher qualification - to a need to work out
a way of doing something faster, better or cheaper that will be of benefit to
patients and staff. Often, many of these reasons will apply to the same project
and hopefully, as experience grows, you will end up doing research because it is
fun and exciting.
One thing to remember: practice research is not simply an academic exercise;
the best research produces believable answers to real questions.
Getting Ideas!
Most good research starts with a good idea.
A few moments' quiet reflection about your own department (Who works there?
What it does. How it functions. Where would people be without it?) is a good
place to start when looking for ideas if you are stuck for a research topic.
More often than not however, questions will arise (sometimes leaping out as if
fitted with springs) during everyday practice, during informal meetings with
colleagues or at formal meetings such as departmental or divisional review, staff
appraisals, drug and therapeutics committee meetings or other professional gettogethers.
Below is a list of likely sources for research topic ideas.
You!: draw from your personal experience as a practising pharmacist.
Your customers: healthcare professionals, managers, patients - what are the
beliefs, expectations, needs and required outcomes of the MI service for these
people?
Your department: are you happy (and, more to the point, is everybody else
happy) with its structure, organisation, functions, responsibilities and
performance? Are any changes to the department imminent? If so, could you
research the effects of change systematically?
Medicines management issues: what impact does (could) the MI department
have on the development, supply and distribution, use and follow-up of therapy?
Could it have a direct input to patient education?
Government initiatives: check health circulars and monitor press reports for
the latest developments.
The literature: let's face it, no one is in a better position to read research
reviews and comb the data for potential new research opportunities than the MI
pharmacist. Reading around a topic can often highlight significant gaps in
knowledge, areas that are ripe for development or where a different research
approach might be useful. The existing literature on research in MI is discussed in
more detail elsewhere.
Academia: there has been much fruitful collaboration between academic and
practice-based pharmacists in the past, because of the applied nature of
pharmacy practice research. Lecturers and readers at your local school of
pharmacy, academic pharmacy practice unit or postgraduate school may be in a
good position to furnish or refine a research idea of common interest. They may
also be able to provide help with study design, data analysis (all those awkward
statistical tests!) and publication of the results. Remember that they too are often
looking for useful, applied research to get their teeth into.
Funding bodies: find out what they are looking for and are therefore prepared
to fund; you may be able to turn that twinkle of an idea you had about extending
your MI service to rest homes into a grant-winning proposal! Writing a proposal
for funding is discussed in a later section.
Previous small studies: perhaps carried out as undergraduate or preregistration student projects or as snapshots or mini-audits in your department.
Things to Think About Early!
Important questions that you should ask yourself before adopting a specific idea
include the following:
Is the idea feasible or can I make it so?
Giving everybody in MI a radiophone headset for hands-free, on-line enquiry
answering may not be very practical (or desirable), but providing at least one
person with such a device and investigating its use may well be feasible.
Has this been done before?
Often quite practical ideas are rejected because the research has already been
done, the results have been published and the jury has given its verdict. This is a
pity. In the author's experience, MI departments vary considerably in their
staffing levels, available resources and MI query profile to the extent that
generalisation of research, even on an inter-Trust basis, is difficult. More often
than not, the same methodology could be applied to your department providing
valid, original and hopefully useful results. Furthermore, any good research report
will identify areas where the researchers see room for improvement in their
methodology or suggest ways of broadening its application that you can adopt in
your own research. This is not plagiarism - this is sound scientific method.
Do I have the expertise?
Obviously, the research needs to be carried out by those competent in its conduct
and analysis and interpretation of the results. Most MI projects have a
multidisciplinary flavour and are the better for it. Academics and statisticians are
often valuable team members. Going it alone is seldom an option and key players
should be identified and 'won over' early in the life of a research idea.
If you are a novice, try and get a more experienced colleague to act as a tutor or
mentor.
How long will it take?
Research projects have a start date and a finish date. These should be realistic.
They are frequently determined by things like patient accrual rates, required
sample size, and research methodologies e.g., using postal questionnaires or
face-to-face interviews. Timetabling the project is discussed further under project
planning.
How much will it cost?
Clearly, an initial costing of the project, to get a ball-park figure, will indicate
whether the project is within existing means, funding will have to be sought, or
the price is so astronomical that the idea is a non-starter.
What use will the results be?
As indicated above, if the idea is a good one (and the subsequent methods you
use are sound and conducted efficiently) then the results will be of some use to
someone. But if you can identify a definite use and user in advance this will be a
useful spur to your efforts.
Can we publish this?
The endpoint of good research should be its wider dissemination, perhaps in the
form of a report for internal consumption or publication in a professional journal.
Aims, Objectives and Hypotheses
While these can be refined as the thought process matures, it is worth jotting
down the aim of the research: this is the question or questions you hope to
answer by doing the study. Don't be over-ambitious; limit the aims to a
maximum of two and make them as clear and uncomplicated as possible.
Sometimes, but not always, it is possible to express the aim as a testable
research hypothesis. Hypotheses should be phrased in such a way that they
lend themselves to statistical testing.
The objectives of the project should then be listed. These are simply the steps
by which the aims are going to be achieved. It is very useful to split the work up
into practical, bite-size chunks that you can tick off as they are completed. If
nothing else, achieving each objective demonstrates command and control of the
project and helps the project stay on course.
Note that objectives only contain the framework of what you will do. They do not
contain things like: 'prepare programme of events', 'send questionnaire for
printing' 'stick stamps on questionnaire envelopes'; these are taken as read. Eight
or nine objectives are probably enough to keep you on course.
Setting aims and objectives will help both your research team and readers of the
final work to decide if you have succeeded in what you set out to do.
If this is your first sail in research waters, it is wise to keep the research aims and
objectives as simple as possible. If you have a couple of reefs in your research
sail to start with, the risks of a capsize are minimised; you can always let them
out as you gain more experience.
Examples of the aims, hypotheses and objectives associated with two projects are
given below.
Examples of Setting Aims and Objectives and Phrasing Hypotheses.
Project 1:
Aim: To assess the impact of supplying information to queries on adverse events
on subsequent patient care.
Objectives:
1. Review the literature.
2. Prepare protocol.
3. Research MI log to identify relevant queries.
4.
5.
6.
7.
8.
9.
Design / pilot questionnaire for mailing.
Mail questionnaire to target correspondents.
Follow-up of non-responders with repeat mailing.
Data collection and analysis.
Report on findings and disseminate internally.
Publish.
Steps 3 and 4 might be modified to include in-depth interviews with
correspondents rather than a postal questionnaire (If you would like to know
more about the results of this particular project, then check out the following
reference: Stubbington C., Bowey J., Hands D. and Brown D. (1998) Drug
information replies to queries involving adverse events: impact on clinical
practice. Hospital Pharmacist 5: 81-84.).
Hypotheses:
Ho (or null hypothesis): the information provided by MI has no impact on
subsequent patient care.
H1 (or alternative hypothesis): the information has an effect (in this case,
either a favourable or an unfavourable one).
Project 2.
Aim: To investigate the effect of promoting MI to nurses on their use of the
service.
Objectives:
1. Conduct literature search.
2. Write protocol.
3. Conduct review of nurse-generated enquiries from MI log.
4. Carry out promotion activities (e.g. meetings, leaflets, posters).
5. Conduct repeat review of MI log.
6. Compare and contrast 3 and 5 above.
7. Prepare report and disseminate.
8. Publish.
Hypotheses:
Ho: promotion of the MI service has no effect on its subsequent use by nurses.
H1: promotion has an effect (in this case, either an increase or a decrease in
use).
The Research Process and Planning
The diagram below shows how the various steps of a research project fit
together.
From previous pages we hope that you have gained the impression that your
research project should be:
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
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
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Useful
Achievable
Original (to your situation)
Well planned
Well managed
Stimulating
All of these things are more likely to apply if they are underpinned by sound
planning. Time spent doing this properly is never wasted. Poor planning may
mean that the results are so meaningless that the you are unable to come close
to answering the original research question. No amount of data massage will alter
the fact that you forgot to exclude certain patients, made no allowance for
confounding variables such as fluctuations in service demand, omitted key
questions from that all important questionnaire or recruited a lamentably small
number of subjects with the wrong disease.
Read Around Your Topic
Find out what is known and what research has been done already. What obstacles
did the investigators encounter? How were these overcome? What were subject
accrual rates like? MI pharmacists should already have skills relating to retrieving,
assimilating and interpreting published work and will be in a good position to
identify gaps in knowledge.
Look at previous reports of research symposia and conferences such as those
organised by UKCPA, RPSGB, PIPA and UKMI (don't forget the poster sessions).
Select a research strategy
Your strategy will depend on the research question you want to answer. Some
questions will suggest a clear strategy: e.g. determining a large number of
correspondents' views on the current MI service is probably best carried out by
using a mailed questionnaire. However, examining ways in which interaction
between pharmaceutical company representative and MI staff could be optimised
might involve in-depth interviews with MI staff, brainstorming sessions, critical
incident analysis or even a focus group (or all of these!). There is always more
than one way of conducting the same piece of research. Use your own
experience, the literature and the views of colleagues with research experience
and your assessment of what is practical to guide you in your choice.
If you want to measure a particular attitude or parameter (e.g. quality of life), it
is worth consulting the literature to see if there are validated instruments or
successful questionnaires already available 'off the shelf'. This is preferable to
spending a vast amount of time developing your own instrument and
demonstrating its quality before using it in the actual project.
A number of excellent publications, full of advice on choosing research methods
are available (see Bibliography).
Discuss your proposal with peers
At this stage, it is an excellent idea to discuss your proposed project with
colleagues, especially if they are to be involved in the research. If the project is
to be run by a multidisciplinary team, then all team members should be involved
from the start and made to feel that their contributions to project design are
valued. What you decide can then be embodied in the protocol that is written
before the research starts and states formally everything that you propose to do.
If you project is of a less grand nature, it is still worth getting the opinion of
colleagues with some expertise in the area of practice you intend to investigate.
You may wish to involve your academic colleagues at this stage to comment on
the proposed methodology and statistical aspects. In this way busy colleagues
may 'buy into' the project and donate their time and skills.
Anticipating things that could go wrong
Think about possible pitfalls associated with you objectives, write them down and
prepare contingency plans for if they happen.
Decide on a time scale
A stated earlier, every project should have a time scale for its satisfactory
completion. Think about how long it is going to take to achieve each of the
objectives and consider the following potential thieves of time in particular:
Thieves of time:
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Literature searching (this should be on-going throughout the study).
Obtaining approval for your study, e.g. research ethics committee
approval.
Obtaining data, particularly things like patients' notes
Obtaining subjects: this will be dependent on, e.g. your exclusion/
inclusion criteria, natural variation in disease pattern, refusal to
participate, migration away from the study area (typically patients and
junior doctors!)
Writing up.
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Staff absences (illness, and more predictably, holidays)
Preparing the research report.
You could prepare a calendar grid on a side of A4, listing the activities that will
take place during the project period, and who is to carry them out down the left
hand side and the time (in weeks or days) across the top. Shade in the boxes of
the grid relating to the time(s) where the activities are due to take place. This
could then be placed in your protocol. Drift from the original project timetable
often occurs; but at least you started out with an instrument to measure that drift
and to see what effect drift in one step might have on all the other activities that
are still to be completed.
Decide on what you are going to do with the results
Are you going to prepare a report for in-house consumption? Or, if all goes well,
are you going to prepare a poster, abstract for conference presentation or submit
the results as a paper for journal publication?
Produce a protocol
This is covered in the next section.
Research Ethics
Depending on who you intend to involve in your research, and particularly if you
intend to involve patient's views or data, you will need to gain approval from the
local research ethics committee. This may be in the form of verbal or written
consent, depending on the extent of the project. If you are in any doubt, then it
is worth consulting with colleagues who have had previous experience of ethics
committees or have conducted research that required approval. Identify the
chairperson of your local Research Ethics Committee and approach them
informally for an opinion on whether Committee approval is required.
If a submission is required, then have your protocol ready in good time for the
next meeting (which can be some time down the line) and complete the
necessary proposal forms These are usually straightforward, but can be rather
bulky. Multiple copies are usually required, so allow time to make them.
Research Ethics Committee perusal has the added value of providing comments
on the research methodology you propose to use; so in this respect you are
getting feedback on your ideas from another, and often well qualified, group of
peers!
More details on the composition and operation of research ethics committees, and
advice on making an application can be found on a separate page.
The Research Protocol
The protocol is:
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The end result of the planning process;
Written before the research begins!
A plan or statement of intent;
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A guide to all those involved with the project, hopefully keeping them on
the straight and narrow and preventing project 'drift';
A benchmark against which to measure progress;
A vital part of any submission to a research ethics committee or a funding
application;
May be included in the final project report with a list of deviations from
protocol (hopefully with reasons).
The protocol should be concise and all members of your research team should
contribute to (or at least approve of) the final version. Reading and re-reading
drafts of your protocol as it develops should stimulate fresh ideas and highlight
possible 'nightmare scenarios' that you can then plan for and incorporate in the
final draft.
Protocol Format
It is wise to be systematic when constructing a protocol. The following sections
should be included:
1. Background (a brief introduction to what is known about the project area,
including previous, relevant research, with references). The background should
also justify why the proposed research is important.
2. The project aim(s), objectives and hypothesis.
3. Methods - a concise description of what you plan to do. (e.g. exact methods,
inclusion / exclusion criteria, statistical analysis - are you going to use a particular
software package to collect and analyse the data?)
4. Timescale of events
5 References.
6. Appendices (e.g. the data collection forms and questionnaires, posters or
information leaflets you will use in your study).
Writing a Funding Proposal
This process can be broken down into a set of steps.
1. Identify potential sponsors. A variety of sponsors may be available. It is likely
that with MI research, your Hospital Trust or Health Authority are likely to be the
major players in providing financial assistance.
Sponsors will be looking for value for money and value-added proposals. In
devising any bid, it is worth emphasising how results obtained at a local level
might be applied more widely to regional and even national level (e.g. Health of
the Nation, National Service Frameworks). Remember that the pool of money
available from any potential sponsor is limited and that you may be competing for
funds with other research groups who will be trying to convince the sponsor that
their project should be top of the heap.
2. Note any maxima or minima on the sums available
3. Obtain application forms and adhere strictly to requirements.
Include all costs for the project.
Think carefully about costs under the following headings:
Materials and equipment
Paper, journals, software, hard ware, publication, photocopying, postage
Manpower
Time lost to other duties, salary of research staff, salary of locum staff to allow
you to conduct the research
Overheads
Travel, subsistence, telephone
Expertise
For specialist skills, e.g. translation of foreign language material, statistical advice
and analysis, consultancy fees
Remember that some establishments may require a 'cut' or 'top slice' of your
funding to pay for their overheads such as heat, light and hardware use.
If the project is an extended one, you might have to claim for more than one
financial year. If so, you should provide for inflation over the life of the project.
Bibliography
See also Research Links
Pharmacy in Practice: Research Toolbox Series
Pharmacy in Practice published a series of six very readable articles by Dr Mary
Tully at the School of Pharmacy in Manchester under the title Research Toolbox.
The articles were designed to help the reader develop some of the skills needed
to take a research project through from conception to the final paper. A real-life
example of a research project (a survey of the use of complementary medicines
by rheumatology patients) is used throughout the series to illustrate the points
that are being made. This series provides an excellent starting point for the
budding practice researcher.
1. Setting up a research project. Pharmacy in Practice June 2000; 10(5):
169-171
2. Basic research designs in quantitative research. Pharmacy in Practice
July/August 2000; 10(6): 207-208
3. Quantitative data: sampling strategy and sample size. Pharmacy in
4.
5.
6.
Practice September 2000; 10(7): 245-246
Questionnaire design and interviewing. Pharmacy in Practice October
2000; 10(8): 292-294
Handling and analysis of quantitative data. Pharmacy in Practice
November/December 2000; 10(9): 314-316
Dissemination - writing a paper for publication. Pharmacy in Practice
January/February 2001; 11(1): 19-20
Mead M.G. (1989) How to carry out a simple research project. Update; August:
309-313.
Bowling A. Research methods in Health: investigating health and health services.
Buckingham, Open University Press, 1997.
Kane E. Doing your own research. Marion Boyars, London, 1990.
Dixon B.R., Bouma G.D. and Atkinson G.B. A handbook of social science research:
a comprehensive and practical guide for students. Oxford University Press,
Oxford, 1987.
Herbert M. Planning a research project: a guide for practitioners and trainees in
the helping professions. Cassell, New York, 1990.
Smith, F. Research Methods in Pharmacy Practice. Pharmaceutical Press, London,
2002.
Robson, C. Real World Research (2nd Edn.). Blackwell Publishing, Oxford, 2002.