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Research | Getting Started | Taking the first steps

Getting Started | 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!
T
hings to Think About Early!
Aims, Objectives and Hypotheses
The Research Process and Planning
The Research Protocol
Writing a Funding Proposal
Bibliography

Introduction top of page

'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?  top of page

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!
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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 get-togethers.

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 pre-registration student projects or as snapshots or mini-audits in your department.


Things to Think About Early!  top of page

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
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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. Design / pilot questionnaire for mailing.
  5. Mail questionnaire to target correspondents.
  6. Follow-up of non-responders with repeat mailing.
  7. Data collection and analysis.
  8. Report on findings and disseminate internally.
  9. 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
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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:

  • 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:

  • 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.
  • 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
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The protocol is:

  • The end result of the planning process;
  • Written before the research begins!
  • A plan or statement of intent;
  • 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
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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
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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 Practice September 2000; 10(7): 245-246
    4. Questionnaire design and interviewing. Pharmacy in Practice October 2000; 10(8): 292-294
    5. Handling and analysis of quantitative data. Pharmacy in Practice November/December 2000; 10(9): 314-316
    6. 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.



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