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Conducting research: The St George's Handbook

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Research skills draw many common parallels with the skills of nursing and midwifery, and the contents of this Handbook offer a toolkit for applying clinical knowledge and skills to research practice. It provides some useful information on the tools, techniques and contacts necessary for nurses and midwives to begin to carry out research.

Research is one of the main ways that we, as nurses and midwives, can develop our practice, knowledge and skills and support our actions with evidence. It should not be thought of as an optional extra, but as something at the very heart of the way in which we approach and evaluate our practice. The skills needed to carry out research are the same clinical skills that we continually develop as a profession: assessment, observation, structured thinking, intuition, accurate recording and presenting of information. The possibility of uncovering new knowledge, finding a better way to do things and improving upon what we already do is an exciting opportunity. What is needed for most nurses and midwives to begin to carry out research is some basic tools that can transform clinical evaluation into clinical research. This Handbook provides some useful information on the tools, techniques and contacts necessary for nurses and midwives to begin to carry out research. Research skills draw many common parallels with the skills of nursing and midwifery, and the contents of this Handbook offer a toolkit for applying clinical knowledge and skills to research practice. The involvement of nurses and midwives in clinical research will ultimately positively impact upon the standard of patient care.

Aims

The handbook aims to provide you, nurses and midwives, with the basic information needed to understand and carry out research. The handbook can help you make decisions about starting and developing research ideas and projects. You can use the book on its own to learn the basics about carrying out researchor as a supplement to any educational courses that you are on. The focus of this book is on the practical aspects of starting to do research.

The handbook is divided into six sections:

  • Section 1: ‘Partnerships’looks at the people you can collaborate with and the plans and preparations you canmake to help improve your chances of carrying out research successfully;
  • Section 2: ‘Research proposal’ gives you an outline to structure your research plans and allows you to consider what the research will actually involve;
  • Section 3: ‘Research Ethics Committee’ gives information to help you through the process of obtaining ethical approval;
  • Section 4: ‘Research funding’gives you advice on where to look for funding for your proposal;
  • Section 5: ‘The research process’ is an introduction to running research projects;
  • Section 6:’Writing up’ provides tips to help you write up the results of your research project for publication.

Not all parts of this book are going to be relevant to everyone. Research Funding, for example, might not be important to ward-based nurses wishing to carry out a small project within their clinical area. Similarly, new research nurses in post may be entering an established research team so that Partnerships has less relevance for them. A handbook isn’t a substitute for getting training and experience in research, but it should help you on the road to gaining these. Aims of the handbook Introduction Nurses and midwives provide most direct patient care in the NHS; they are taught to reflect on their practice and generate new ideas and should be well placed to carry out research into nursing. However, most nurses and midwives receive little or no training in research and few have the opportunity to gain experience in it. This lack of knowledge and experience, coupled with the clinical demands on their time, can result in nurses and midwives both giving research a low priority and being slightly fearful of what it may involve. However, the continuing need for evidence-based practice and the drive for better patient care means that research is going to play a bigger part in the working lives of nurses and midwives. Research can involve nurses and midwives observing and recording the experiences of patients receiving care or colleagues going about their normal duties. It might also involve testing out a new procedure or medicine and comparing it with existing treatments. This type of research can be done by individuals within their units or can involve leading a research team after getting appropriate funding. Whatever is being researched, at whatever level, more nurses and midwives need to be doing more of it. This handbook aims to help you to better understand what is involved in the research process and to encourage you to either start doing some or, if you are already involved in research, doing more. It gives details of what the various stages of research can involve and provides contacts and links that will be useful to you. Nobody carries out research alone, so start talking to others about your ideas and then have a go.

Links

For access to Department of Health (RDDirect) Research Process Flowchart www.rddirect.org.uk For access to the RCN Research and Development Co-ordinating Centre www.man.ac.uk/rcn

Section 1

Partnerships

The best time to find out whether research ideas are any good and are practical, or have any weaknesses and are impracticable, is at the beginning of the research process. A good way of achieving this is to collaborate with others who have expertise and experience in thefield of nursing you wish to research.

Colleagues

Often the most usefulfirst contact if you wish to discuss a research idea is your colleagues. Certainly if you are planning to carry out any research in your area of work it is going to need the co-operation of staff working there; so mentioning it as early as possible will be useful. Keep a note of those who express a willingness to be involved. As well as informal discussions, use the opportunity of ‘handovers’, staff meetings or department seminars to promote discussion of your ideas. You may wish to use an ‘idea’ book in which staff are invited to enter questions they may have regarding clinical practice. At the end of the month you could go through these questions to see if a theme or research question had arisen.

Collaboration

A group of people who can helpin the formation of a research proposal, and who can later form a steering committee to supervise the research project, is extremely useful. There are no strict rules about who should or should not be collaborated with; anyone who is willing and helpful is perhaps an appropriate rule of thumb. Collaborators inside the Trust may be more practical than external ones, although partnership with other institutions can have its own benefits. An ideal list of collaborators/steering committee members may well include:

  • Nurse or midwife leading the research (principle investigator)
  • An experienced researcher with a track record of attracting funds, managing and publishing research in this clinical area
  • A clinical expert in the area of nursing or midwifery being researched
  • A member of the multi-disciplinary team working in the area being researched
  • An academic expert in the area of nursing or midwifery being researched and/or research methods
  • A junior member of staff from your area of work who shows an interest in research
  • A member of staff showing willingness and support.

Reviewing the literature

The next step in refining an idea for a research study is usually to consider what evidence already exists on the subject. The most efficient way of doing this is to carry out a review of the literature using the available electronic databases. Most University Libraries will undertake literaturesearchesfor staff by request and some run workshops on how to conduct literature searches. You will need to book these workshops in advance and can also enquire at the library about getting an Athens password (which will allow you to access various internet databases). Once you have reviewed the existing evidence on the topic you are thinking of researching, try to applythis knowledge to your original research idea and see if you need to alter what you plan to do.

Research contacts

There are normally many people within a Trust who are experienced at carrying out research and who are available to offer assistance and advice to nurses and midwives wishing to do likewise. Many Trusts list these on their intranet so you can identify contacts that are already involved in research and/or are aware of the body of evidence in their field of nursing. Check whether these contacts are willing to have a quick chat with you about your research question, and if not ask them to suggest a suitable substitute. People involved in research are generally happy todiscuss ideas with fellow professionals and are pleasedto be asked to assist in the development of researchproposals. You should not hesitate to contact authorsof relevant papers that you have read, or speakersthat you hear, to ask for help.

Links

Academic departments that offer a health related course. Gives details for each instituteand areas of research in which they specialise. www.man.ac.uk/rcn/academic/

RCNResearch and Development Co-ordinating Centre www.man.ac.uk/rcn/

Section 2

Research proposal

Once the research ideahas been discussed with colleagues and potential collaborators it is worth writing it up in the form of a research proposal. This proposal is a way of planning what needs to be done for the research to take place.You can then circulate the proposal for comments and, once amended, use it as the basis for any proposal for funding and for any application for approval from the Research Ethics Committee. The proposal should be dated as in practice there are usually amendments during development and this ensures the most up-to-date proposal is used. The following template is a suggested form for structuring your research ideas but should be altered to suit your needs or the needs of the proposed study being described. The proposal does not have to be fully completed before you circulate it to colleagues and potential collaborators for comments and completion.

Proposal

Template

Proposal summary This summary sheet is usually written after the proposal is completed.

Study title As full title above, can be short title or acronym if required.

Study centre Site where study is taking place.

Aims/objectives Sentence describing the main outcome of the study.

Study population Group of subjects (patients, clients, staff etc) being studied.

Number of subjects Estimated number of subjects required.

Study design Type of research (i.e. pilot study, randomised controlled trial, qualitative designs, postal survey) being carried out. Sentence describing methods of study.

Assessments Sentence describing all data /measurements /assessments being collected.

Withdrawal criteria Sentence describing conditions in which participants can withdraw from study.

Contact Name and telephone numbers of investigators.

Background This section should outline the current clinical/research situation and the nature and extent of any clinicalor health problems that exist within this situation. A case is made for the need for research to be carried out in this area and then the study objectives are listed. This section should aim to be between 500 and 750 words long and should be appropriately referenced. The following is an example of paragraph contents.

  • Prevalence/incidence/trends of topic being studied. This paragraph should detail the extent of the problem.If any government targets exist addressing this topic then they should be mentioned here.
  • The second paragraph should detail the nature of the problem. The health consequences or ill-health consequences (morbidity and mortality) of the topic should be detailed and referenced. Treatment, service and financial implications can all be mentioned.
  • This, the third, paragraph is a brief review of the literature on this topic. Previous research into ways of addressing this problem should be listed, critically analysed and referenced. The final sentence should state what is needed in terms of research to advance understanding of this topic.
  • 4. This brief final paragraph lists the objectives of the proposed study.

Study design

Overview

Two or three sentences summarising project outline. This section should outline what the project aims to do and how it aims to do it.

Methodology

You will have discussed this section with colleagues and potential collaborators; it explains what is actually going to happen and should be written as if explaining ‘step-by-step’ to someone. It has to be accurate enough so that someone could replicate your study and it will not be wasted as some of this material will be used when you write up the study. Two or three paragraphs are required detailing the critical methodological events of the research process in the order that they will happen. For example: how subjects are recruited, inclusion/exclusion criteria, randomised to control or active groups and consent obtained. Also, how treatment is given, outcomes measured and data collected and analysed.

Measures

Paragraph describing all data, measurements and assessmentsbeing collected. This would include, for example, describing all questions that are asked of subjects either directly or via questionnaires, or samples taken and what they will be analysed for. Draft data collection forms (questionnaires, case record forms [CRFs] etc) can be included as appendices.

Sample size

Whether carrying out qualitative (e.g. semi-structured interviews) or quantitative (e.g. randomised controlledtrials) research, you need to make sure you have enough subjects to be able to get ‘valid’ results. Sometimesthis will require a power calculation to estimate the number of subjects you need. An experienced researcheror statistician will help you with this.

Withdrawal from the study

Sentence describing conditions in which participants can withdraw from study. For example: participant wishes to withdraw from study, does not keep all study appointments or does not comply with the study protocol.

Data management

Sentence describing how the data will be collected, stored and analysed. For example: no outside bodieswill have access to the data. Data will be in questionnaire form and entered on a computer in an anonymousform. Differences in proportions will be assessed by logistic regression, controlled if necessary for any baselinedifferences between the samples. Differences in quantitative measures will be assessed by analyses of varianceor covariance if control for baseline differences is required. For quantitative measures that deviate substantiallyfrom a normal distribution differences will be assessed by Mann Whitney test. Again an experienced researcheror statistician will help you with this.

Study timetableWho is doing what and by when; requires a short paragraph or sentence outlining proposed start date ofstudy and duration. For example: the proposed study would commence March 2006 and run for twelvemonths. First three months will involve literature review and setting up of study, second six months will involverecruitment and final three months will involve data analysis and writing up.

References

Referenced according to Vancouver (numbered) or Harvard (author, date) system. Pilot Studies A small pilot study to test the proposal and/or materials you plan to use is sometimes useful (e.g. questionnaires and scales may need testing out on the suggested subjects first). Evidence that your proposed research is practical can be persuasive for funding bodies and is also useful so that you can judge recruitment.

Reading

Nursing Research: principles, process and issues Kander Parahoo Publisher: Palgrave MacMillan ISBN: 0333699181

Nursing Research: principles and methods Denise Polit-O’Hara, Bernadette P. Hungler,Denise F. Polit Publisher: Lippincott Williams and Wilkins ISBN: 0781715628

The Research Process in Nursing Desmond Cormack (Editor)Publisher: Blackwell Science (UK) ISBN: 0632051582

Qualitative Methods in Psychology: a research guidePeter Banister, Erica Burman, Ian Parker,Maye Taylor, Carol Tindall Publisher: Open University Press ISBN: 0335191819

Evidence-Based Practice:a primer for health care professionals Martin Dawes, Philip Davies, Alastair Gray,Jonathan Mant, Kate Seers, Robin SnowballPublisher: Churchill Livingstone ISBN: 0443061262

Section 3

Research Ethics Committee (REC)

For each locality there is a local Research Ethics Committee (REC) and also the Central Office of Research Ethics Committees (COREC) with a single form and guidance on carrying out research. As the titles of these committees suggest, they exist to ensure that any research that is carriedout is of an ethical nature. Their purpose is not necessarily to consider the merits or practicability of proposed research, although their advice is normally very useful, but to safeguard the interests of patients and the researcher. The Wandsworth REC meets monthly to consider submitted proposals. If you are unsure as to whether your research proposal requires REC approval then you should write to the chair, outlining your research question and including your proposal. All research studies involving the NHS (patients and/or resources) will require REC and Research and Development approval in meeting research governance requirements.If it is your first time completing a REC submission form then get help from someone who hasbeen through the process before. The links below provides plenty of information on theResearch Governance Framework and assistance on completing and assisting REC applications.

Research governance

At the same time that you send your proposal for ethical approval it should also be sent to the R&D Department for research governance approval. This is separate from the REC process but is essential before you begin your research.

Data Protection Act 1998

As with nursing and medical notes, any information that you collect from patients, clients and subjects is covered under the Data Protection Act. Information on the Data Protection Act is easiest to find on the St George’sUniversity of London website (see links below) and located on the webpage is a list of Data Protection Co-ordinators.

Informed consent

Informed consent means allowing potential recruits to your research study to have sufficient information to allow them to decide whether or not they want to take part. The first part of this requires an information sheet that should contain information under standard headings as appropriate. The information sheet should be written in simple, non-technical terms and be easily understood by a lay person. Use short words, sentences and paragraphs. The second part of this process requires a consent form. Examples and guidance can be found on the NHS Central Office for Research Ethics Committees (COREC) website (see links below).

Links

NHS Central Office for Research Ethics Committees(REC forms are available from the COREC website) www.corec.org.uk

Department of Health Research GovernanceFramework. V2 (2005) www.rdforum.nhs.uk/home.htm

NHS R&D Forum - Research Management

Section 4

Research funding

All research costs something in terms of both money and time.It may be that these costs are minimal with small projects and can be absorbed by your unit or will require specific funding from within the Trust or without. Get advicefrom your colleagues, line manager and potential collaborators about what your research project may cost and where best to apply for funding.

Links

Department of Health (RDDirect) Site detailing funding opportunities. http://www.rdinfo.org.uk

Register withRoyalCollegeof Nursing Research and Development Team and receive news of funding opportunities weeklywww.rcn.org.uk

US Community of Sciences (COS) sitewww.cos.com/

The research process

Finances

Once you have secured funding for your research project (whether it is a large amount from an external funding body to employ a research team or a small amount to cover the cost of photocopying) you need to make sure you keep an eye on things. Make sure you know who has access to the study account and account codes, and know what is paid in and what is taken out.

Recruitment

You should have a clear idea already how many subjects you need for your study (see Sample Size, Research Proposal Template), who they are and how you can contact them. Do not delay in this as recruiting subjects is often one of the most difficult parts of research. Remember: no subjects, no data.

Project steering committee

Use your collaborators to form a steering committee that can meet regularly: perhaps monthly at first but more usually quarterly. The main function of this committee is to receive reports about the progress of the study (i.e. recruitment of subjects), sanction any changes to the research protocol and act as a source of advice and help to you.

Data confidentiality

All the data you collect from patients, from questionnaires to the results of clinical tests, needs to be kept secure and confidential. Data should be stored in a lockable filing cabinet in a lockable room - when you are not there, both should be locked. When samples or data are sent outside of your unit (e.g. for analysis or statistical testing) any identifiers, such as name and date of birth, should be replaced by a sample or data code. The list that identifies the subject against the code should also be stored securely. Statistical analysis This is the part of research that most nurses and midwives dread, but like most things it does get easier with practice and good quality help is essential. Statistical advice should be available from your collaborators for each of the phases of a project, including analysing the data.

Reading

Simple Statistics A course book for the social sciences Frances CleggPublisher: University of Cambridge ISBN: 052128809#

Medical Statistics Made EasyMartin Harris and Gordon TaylorPublisher: Martin Dunitz, Taylor and Francis Group ISBN: 185996219X

An Introduction to Medical StatisticsMartin BlandPublisher: OxfordUniversity Press ISBN: 0192632698

Research Methods and Statistics in Psychology Hugh CoolicanPublisher: Hodder and Stoughton ISBN: 0340524049

Section 6

Writing up

Think about who would be interested in your research and which journals are read by those people. Before writing a paper for publication it is worth checking the websites of potential journals, or contacting their editorial team, to determine what types of papers they publish and what the instructions for authors are. It is difficult to remember all the elements and rules that make a good research paper. This detailed checklisthas been designed to be for guidance only, bearing in mind that in certain cases some of the rules will not be relevant. It was also designed to cover many types of clinical, social and behavioural research. You should always study the requirements for authors of the journal you are submitting to. (Fig 1) Research process flow chart

Research stage Where to get help
Generating and refining your research idea Discuss with patients, relatives and colleagues
Reviewing the literature(what is already known) University Library
Forming a research question Review the evidence, relate it to your original idea and discuss it with colleagues
Drawing together a group of collaborators Colleagues, clinicians, academics and members of the multi-disciplinary team
Planning the study and writing a research proposal Project steering committee
Applying for Research Ethics Committee (REC) approval Project steering committee, local Research Ethics Committee and Central Office for Research Ethics Committees
Applying for funding Project steering committee
Carrying out the research Project steering committee and colleagues
Writing up your research results Project steering committee and colleagues
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