Introduction
Why I wrote this book
The purpose of this handbook and who it is for
How to use this book
What this handbook cannot do
Acknowledgements
Part 1 Getting started and planning your research
1 Taking stock
1.1 What is research?
1.2 Who does research?
1.3 Why should I do research?
1.4 What makes a successful researcher?
1.5 Research, audit and service evaluation
1.6 The stages on research
1.7 Resources
1.8 Reference
2 Research governance
2.1 Ethics
2.2 Science
2.3 Information
2.4 Health, safety and employment
2.5 Finance and intellectual property
2.6 Quality research culture
2.7 Your responsibilities
2.8 Systems to deliver excellence in research
2.9 Monitoring, inspection and failures
2.10 Resources
3 Formulating your research question
3.1 Be specific
3.2 Be realistic
3.3 What next?
3.4 Resources
4 Reviewing the literature
4.1 How to search the literature
4.2 Reference management
4.3 Making the most of the library
4.4 Resources
4.5 References
5 Critically appraising papers
5.1 How can it help?
5.2 How do I critically appraise research papers?
5.3 Other things to think about
5.4 Appraising the statistics
5.5 Journal clubs
5.6 Resources
5.7 References
6 Choosing the right research design
6.1 The hierarchy of research evidence
6.2 Types of research
6.3 Quantitative research
6.4 Qualitative research
6.5 How to choose the right research design
6.6 Resources
6.7 References
7 Writing the initial research protocol
7.1 Why do I need a research protocol?
7.2 How is a protocol structured?
7.3 Peer review of your protocol
7.4 Resources
7.5 Reference
8 Getting started with statistics
8.1 Back to basics
8.2 Use of statistics throughout the research process
8.3 Resources
8.4 References
9 Successful grant applications
9.1 Four keys to success
9.2 Is it being funded already?
9.3 What funding is available?
9.4 Find out about the funder
9.5 Patient involvement
9.6 The application
9.7 How you will be judged
9.8 Acknowledgements
9.9 Resources
10 Obtaining approval for your research
10.1 The two routes to ethical approval
10.2 The application form
10.3 Confidentiality
10.4 What else do I have to submit with the main form?
10.5 How to choose which REC to apply to
10.6 The submission process
10.7 What happens after submission?
10.8 Getting research and development approval
10.9 How long will it take?
10.10 What happens next?
10.11 Resources
11 Participant consent
11.1 What is informed consent?
11.2 Taking informed consent
11.3 Ongoing informed consent
11.4 Taking consent from people who cannot give it
11.5 Including children in research and obtaining consent
11.6 Storing consent forms
11.7 Resources
11.8 References
Part 2 Doing the research
12 Collecting your data
12.1 Confidential patient information
12.2 Screening form
12.3 Data collection
12.4 Other forms and equipment
12.5 Design your database
12.6 Code book
12.7 Preliminary data checking
12.8 Resources
12.9 References
13 Recruiting volunteers
13.1 In or out-patients from your hospital or health care unit
13.2 Volunteers from the general public
13.3 Keeping recruitment records
13.4 Informed consent
13.5 Resources
14 Data management and analysis
14.1 Quantitative research
14.2 Qualitative research
14.3 Resources
14.4 References
Part 3 Writing up and dissemination
15 Disseminating your results
15.1 Planning how to disseminate your results
15.2 Presenting at a scientific conference
15.3 Publishing in a peer reviewed journal
15.4 Authorship
15.5 Clear writing
15.6 Resources
16 Preparing for a conference presentation
16.1 Submitting an abstract
16.2 Preparing a poster for a conference
16.3 Preparing for an oral presentation
16.4 Resources
17 Writing a paper for a journal
17.1 General advice
17.2 What goes in each section?
17.3 The writing strategy
17.4 What happens after submission
17.5 Resources
End note
Index
This edition first published 2008
© 2008 Mary Hickson
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Library of Congress Cataloging-in-Publication Data
Library of
Hickson, Mary, 1966–
Research handbook for health care professionals / Mary Hickson.
p. ; cm.
Includes bibliographical references and index.
ISBN-13: 978-1-4051-7737-5 (pbk. : alk. paper)
ISBN-10: 1-4051-7737-3 (pbk. : alk. paper) 1. Medicine–Research–Methodology. 2. Medical writing.
I. Title.
[DNLM: 1. Research Design. 2. Writing. 3. Evidence-Based Medicine. 4. Health Services
Research–methods. W 20.5 H631r 2008]
R850.H47 2008
610.72–dc22
2007047502
A catalogue record for this book is available from the British Library.
1 2008
I have been involved in research throughout my career as a dietitian; in fact my first job after qualifying was to run a research study. I then spent several years developing my clinical skills, before I came to the point within my work where I was faced with questions that I wanted to answer, and I was in a position to do so. I started with hesitant steps on the research pathway, my goal being to find information that would inform my practice and improve the care I gave to patients. My research career really began with a job running a randomised control trial, which enabled me to work towards a PhD. This gave me a grounding in the research process with hands on experience, as a PhD is designed to do. My job now is all about helping others to do research, and developing research capacity and capability within all therapy groups in the Imperial College Healthcare NHS Trust. This book has come from my experiences of teaching and supporting others who are new to research and those with some experience.
One of the best things about research is that I am constantly learning, developing skills and being faced with real challenges. Looking back on my career and research experiences I feel that there is a need for greater guidance for novice researchers. Of course, the people around me gave excellent support, guided me to the numerous detailed quality texts available for many of the individual stages in research (research methods, statistical analysis, writing skills), and directed me to suitable sources of information. Nevertheless, I would have really valued an overview of the whole process. Not everyone is in an environment that nurtures research and so I have aimed to write a book that can act as a guide, keeping researchers focused on the process and steering them towards further resources.
This handbook aims to provide a starting point and a helping hand to guide you through the whole research process step by step. It introduces research in a practical and user-friendly way to student and qualified health professionals. It is primarily aimed at those people completely new to research, but experienced researchers will find many new tips and useful reminders. The handbook also provides a reference to the vast array of resources available for the researcher, and directs you to many other potential sources of more detailed information. So if you are leading, managing or coordinating research this handbook will provide you with a starting point for advising researchers.
Most text books distinguish clearly between the two philosophical approaches to research, concentrating on either quantitative or qualitative methodology. Although my roots are in quantitative research, I have learnt and used qualitative methods. Both approaches are valuable, answering completely different types of question. The important thing is to choose the appropriate research methodology for the issue you are exploring. This book incorporates guidance on both approaches to research and is therefore useful for science and social based health professions.
Experienced researchers or those managing research can dip in and out of this book; each chapter stands alone and can be used in isolation. Links to information in other chapters are made clearly.
If you are new to research you will need to start at the beginning and work your way through. I have divided the research process into three distinct phases: planning, doing and disseminating, and each chapter takes you through one part of these phases.
Throughout the book examples are included to help illustrate the processes or issues discussed. The aim of this book is to be a quick guide to the research process which you can use again and again over the years as you develop your research skills.
Research is a complex process that requires many different skills, and knowledge of specific regulations and procedures. This handbook cannot replace the valuable exchange of knowledge, skills and experience that accompanies one-to-one advice, and I would urge all novice researchers to find support from experienced people within their field or organisation. The handbook is a starting point to provide background information, to help you gain an understanding of the basic concepts involved and to facilitate a smoother journey into the wonderful world of research.
There are many other excellent texts currently available to help you through the individual stages of the research process, and many of these are listed in the resource section of each chapter. No single book can teach you everything and it is important to read widely and gain your knowledge from a variety of sources.
It is also important to remember that many procedures relating to research are locally agreed and as such this book can only offer a guide. Each organisation or NHS Trust will have specific policies and procedures, varying resources and a different focus on research. You will need to familiarise yourself with how your organisation operates.
Health research is dynamic and developing and so there is a constant need to update and review all parts of the research process; this handbook will be no exception. Please note that all the web-site addresses were checked in September 2007 and were accurate at that time. Also beware that information on the internet can be changed and updated at any time and so the author takes no responsibility for the quality of the information on the listed sites.
I would like to thank the following people who have provided advice, comments or simply lots of encouragement:
My colleagues at Imperial College Healthcare NHS Trust including Gary Frost, Jo Partington, Caroline Alexander, Davina Richardson, Rodney Gale and many of the staff in Therapy Services whom I help as part of my job. In particular I thank Davina Richardson for her help with the sections relating to qualitive research.
Judy Lawrence, Kevin Whelan, Julie Lanigan, Anne Holdoway and other members of the British Dietetic Association Research Committee.
Members of the Allied Health Professions Research Forum.
Members of the Dietitians Research Network, in particular Miranda Lomer.
Debbie Snell, Ailsa Brotherton, Elizabeth White, Kate Radford, Alison Culkin, Anna Horwood and Emma Kehoe for recommending specific resources.
The anonymous reviewers of the book proposal.
Finally, I would like to thank my husband, Chris, for his patience, support and his time spent proof reading, and without whom this book would have not been finished.
The first phase of any research project is to plan exactly how you will carry it out. Good and thorough planning will pay huge dividends when you come to collect data and do analysis. It is important to understand that this phase will take many months, but it is worth doing properly to ensure your final results will be of value and merit publication.
Chapter 1 will help you think through the feasibility of carrying out research where you work, and Chapter 2 gives you a background to how research is governed within health care. The ten chapters following take you step by step through each stage of the planning process.
This first chapter should help you assess whether research is for you. Research requires certain skills and it is not for everyone. It is worth thinking through what skills you have, what support is available and how much backing your organisation can give.
Research is the systematic investigation of a specific question in order to establish new facts and draw new conclusions. It involves the discovery of new knowledge and the interpretation and revision of current knowledge.
The process involves asking a question; collating and integrating current knowledge on the topic; designing a method to collect information to inform the research question; and finally developing new conclusions from the evidence.
Evidence-based practice is encouraged throughout medicine and related professions in order to ensure the treatments and processes we use are sound. Research provides the evidence. Involvement in research can be at various levels. Every health professional should be able to use research; in other words, find and critically appraise the work of others and decide whether it provides enough evidence to change practice. To achieve this some level of research training is given to all health professionals and many students are required to carry out small research or audit projects to practise these skills.
Getting more involved in research could mean helping carry out a research project; perhaps by providing clinical expertise to inform part of a larger project. This would mean that more experienced researchers will lead the project but it will provide an opportunity to start to learn the processes involved in research.
The next level would be to become part of a research team to develop a project, find funding and carry it out. More experienced clinical staff may find research at this level attractive since it offers a method to find answers to problems and improve patient care.
Finally, some health care professionals may wish to pursue a research career in parallel with, or instead of, their clinical career. To do this, a PhD is a minimum requirement, but this qualification could open doors to academic careers, leading research programmes, or teaching others.
The majority of research activity and support tends to be concentrated in larger NHS trusts and particularly in those departments with strong links to universities and teaching students. Nevertheless, research can be successfully carried out in any part of the health service if you have the will and drive to make it happen.
Universities are also centres of research and most successful health researchers will either work for, or have strong links with, a university. Health research is also carried out by commercial organisations and many charities are involved in funding and commissioning research.
All health care professionals are duty bound to provide care that is based on the best evidence available, which demonstrates that the particular therapy, intervention or technique actually works. Not all people are inspired to undertake the task of discovering new evidence, but all health professionals do need to understand how research is done and how to interpret the findings of others. Much of the first part of this handbook will help guide anyone through the process of finding, appraising and interpreting research. Other people will find the challenge of discovery appealing, and for those, the rest of the handbook will offer guidance on how to tackle the process.
First and foremost it is important to realise that research is nearly always a team effort. Do not be seduced into thinking this means all members of the team share the workload equally; if the research is your idea and you are leading the project you will end up doing the bulk of the work. Nonetheless, having other more experienced people on the team means you can draw on their expertise and approach them for advice when you need it. This certainly means you will avoid many errors and it will also save you time. Since health care is often team oriented, there are many opportunities to link into ready formed teams to benefit from their experience and guidance.
Some of the characteristics a researcher needs are an ability to work methodically with attention to detail, good time planning and organisational skills, and an ability to communicate clearly. A good researcher also needs patience, determination, persistence and a thick skin to deal with rejection! Underpinning all of these traits good researchers must be curious, always questioning what they do, and they need to have a desire to pursue answers in the face of many difficulties. If you can identify with this description, research may be just the challenge for you.
On top of these personal characteristics, successful researchers need appropriate support from the organisation in which they work. This includes an environment where:
Published research suggests that overall it is having a supportive positive climate in which people can undertake research that has the most impact on research output and success (Bland & Schmitz 1986). You need to think realistically about the place where you work and consider how you will be supported and encouraged to pursue research projects. Try and locate researchers within your organisation and gain their help and support.
This chapter should help you consider whether you are in a position to pursue a research study or develop a research career in your current organisation. There are many transferable skills you can develop independently, but you also need to place yourself in an appropriate environment to really succeed. Research cannot be at the top of everyone’s agenda and sadly this means some dedicated and enthusiastic people can be deterred from this career option; but if you feel research is for you, it is worth persisting and finding the support you need. Research makes for a creative, challenging and satisfying career.
While research is encouraged within the health service as a means to improve patient care and safety, it is not the only way to do so. The two main alternatives are audit and service evaluation. Although these two processes require some of the same skills as research they are distinct processes with different aims. Table 1.1 outlines the differences between the three processes in detail, but the single key discriminating factor is that of intent. The primary aim of research is to derive new knowledge; audit and service evaluation measure level of care. Research finds out what we should be doing; audit is to find out if we are doing it.
Research | Clinical audit | Service evaluation |
Designed and conducted to generate new knowledge. | Designed and conducted to ensure the best care is provided. | Designed and conducted to define current care. |
Designed to fill gaps in the knowledge base. | Designed to answer the question: “Does this service reach a predetermined standard?” | Designed to answer the question: “What standard does this service achieve?” |
Quantitative research – hypothesis based Qualitative research – explores themes following established methodology. |
Measures against a standard. | Measures current service without reference to a standard. |
Quantitative research – may involve evaluating or comparing interventions, particularly new ones. Qualitative research – usually involves studying how interventions and relationships are experienced. |
Involves an intervention in use ONLY (the choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference). | Involves an intervention in use ONLY (the choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference). |
Usually involves collecting data that are additional to those for routine care, but may include data collected routinely. May involve treatments, samples or investigations additional to routine care. | Usually involves analysis of existing data, but may include administration of simple interview or questionnaire. | Usually involves analysis of existing data, but may include administration of simple interview or questionnaire. |
Quantitative research – study design may involve allocating patients to intervention groups. Qualitative research uses a clearly defined sampling framework underpinned by conceptual or theoretical justifications. |
No allocation to intervention groups: the health care professional and patient have chosen intervention before clinical audit. | No allocation to intervention groups: the health care professional and patient have chosen intervention before service evaluation. |
May involve randomisation. | Does NOT involve randomisation. | Does NOT involve randomisation. |
Although any of these three may raise ethical issues, under current guidance: | ||
Research requires Research Ethics Committee review. | Audit does not require Research Ethics Committee review. | Service evaluation does not require Research Ethics Committee review. |
Adapted from National Patient Safety Agency leaflet Defining research 2007: Research, clinical audit and service evaluation.
This book is specifically aimed at those undertaking research; nevertheless many of the skills and processes are the same for doing audit or evaluation projects.
All research, both qualitative and quantitative, will fall into the three distinct phases; planning, doing and disseminating. Each phase includes several stages. A few of the stages may be optional; some research may not need funding, and statistics will not be needed for qualitative research. Figure 1.1 is a flow diagram of the process and illustrates how this book links with each stage. This will enable you to use the book more effectively and gain an understanding of the bigger picture.
To find out if you have a Research and Development Support Unit (RDSU) near you check: http://www.national-rdsu.org.uk/. RDSUs are funded by the Department of Health to support high quality and multi-disciplinary health and social care research.
RD Direct is the national advice service for researchers funded by the Department of Health and provides advice about the whole research process. Access at: http://www.rddirect.org.uk
For more experienced researchers this website may be of interest, which provides an online resource to support the leadership development of Principal Investigators: www.le.ac.uk/researchleader/index.html
Contact your professional organisation as many have a variety of mechanisms for promoting and supporting research activity, such as web downloads or library resources. For example, College of Occupational Therapy Briefing 75; Research Resources for Occupational Therapists (2007).
Wade D. (2005) Ethics audit and all shades of grey. British Medical Journal, 330, 468. Available free at: www.bmj.com
Casserat D, et al. (2000) Determining when Quality Improvement Initiatives should be considered research. Journal of the American Medical Association, 283, 2275.
National Research Ethics Service, Defining Research 2007: National Patient Safety Agency, London. Available free at: http://www.nres.npsa.nhs.uk/docs/guidance/NRES_leaflet_Defining_Research.pdf
Bland, C. J., & Schmitz, C. C. (1986) Characteristics of the successful researcher and implications for faculty development. J.Med.Educ., 61(1), 22–31.
Before I begin to talk about the process of research I should first explain how research is managed and controlled in the UK. This should clarify, as you read through the following chapters, why some things have to be done in prescribed ways.
Research is vital for improving health care but does contain an element of risk, both in terms of return on investment and to the individual research participants. In order to ensure high scientific, ethical, safety and financial standards in research the Research Governance Framework for Health and Social Care has been developed. This describes how standards should be maintained, how decision making should be carried out, how research should be monitored and to clearly allocate responsibilities to all parties involved in the research process.
All research undertaken in the NHS or social care systems is governed by the research governance framework and the full details are available on the Department of Health website (www.dh.gov.uk – search for ‘research governance’). Before undertaking any research you should be familiar with the research governance framework for the country in which you work. There is a separate framework for England, Scotland, Wales and Northern Ireland, but the frameworks all cover the same key topics. The governance framework is a guide for best practice and the details of how the framework is implemented may vary from organisation to organisation, so you must contact your R & D office for clarification.
The frameworks cover the following key areas:
Many of these areas will be covered in more detail in other chapters, but a preliminary overview is given here.
This section of the framework is wide ranging and includes: independent ethical review; informed consent; valuing patient diversity; patient confidentiality; data protection; use of tissue or organs; the use of animals; and involvement of patients in research. The guiding principle is that the dignity, rights, safety and wellbeing of participants must be the primary consideration in any research study.
The requirements for the ethical review of research and participant consent are covered in Chapters 10 and 11.
Patient involvement is an area of increasing importance and all new funding streams in the National Institute of Health Research ask for specific information about this. Patients can be successfully involved in all stages of the research process at a number of levels. Patient involvement is about more than just consulting patients but also seeking to collaborate or even encouraging patients to lead the development of the research question and methodology. This can be a challenging area for researchers since traditionally, patients and the public have had little or no input into what health research is carried out in the UK and particularly in the NHS. Advice is available from INVOLVE (www.invo.org.uk), and they provide examples of how patients can be successfully included into planning research.
This part of the framework aims to ensure that all new research builds on the learning of previous work and will add something new and useful to the body of knowledge once complete. Thus, adequate review of the relevant literature is vital. Reviewing the literature is covered in Chapter 4.
The framework also makes clear that peer review by experts in the relevant fields is essential for all research to maintain scientific quality. The level of peer review should reflect the size of the study and its inherent risks. For example, a large and expensive clinical trial is likely to need review by an external panel of experts, whereas small unfunded projects could be reviewed by one or two people within the organisation. The arrangements will vary locally but there should be a system for peer review available.
This section of the framework covers the use and dissemination of information arising from the research. The general principle is that all results should be made freely available subject to appropriate scientific review, and also be in a format understandable by the general public. The framework recognises that there may be issues around intellectual property or possible commercial development of the results of research and allows flexibility in the timing of the publication of results.
The framework emphasises the importance of health and safety regulations. You must make sure you are following all health and safety guidelines in force in your organisation. We are all responsible for our own and others’ safety, and should act with this in mind. If you need to undertake any specific activity or procedure make sure you have been trained to do so in a safe manner, and understand the relevant health and safety regulations, such as regulations for working in a laboratory, taking blood, or operating equipment.
The Research Governance Framework says, ‘A researcher not employed by any NHS organisation who interacts with individuals in a way that has direct bearing on the quality of their care should hold an NHS honorary contract.’ (Section 3.10.3 of the Framework of England). It does not say every Trust must issue its own honorary contract, although in practice this is what tends to happen. This involves researchers going through an identical process several times in order to work in several different Trusts. This has been recognised as a waste of time and resources, so a researcher passport scheme has been piloted to avoid this duplication of information. Nevertheless, as yet there is no consistent approach, so you must check the local situation with your R & D or Human Resources Department. The NHS R & D forum may also provide helpful advice (www.rdforum.nhs.uk).
The framework underlines the need for compliance with the law and with the rules set out by HM Treasury for the use of public funds. It covers guidance on intellectual property rights, and it also covers the issue of indemnity against negligent and non-negligent harm to research participants, which is required to protect participants in trials. Research run within the NHS is covered by the standard complaints procedure, and the patient information sheet must include the indemnity procedure for the research. Sample wording is given in the National Ethics Research Service guidance (for website address see resources section).
If your research is being run in collaboration with an academic or commercial organisation there will be different indemnity arrangements. The National Research Ethics Service form asks for details of these, which you should be able to obtain from your local research services office or other management department.
The framework recognises that although some parts of its guidance are clear and unequivocal, other parts require interpretation and judgement. In order to carry out high quality research that will meet all other requirements of the governance framework, strong research leadership and expert management is required. To engender an environment that will nurture excellence in research the following are listed as key principles:
The framework also outlines the responsibilities of each person involved in research and Box 2.1 lists the main people and organisations involved. Each person or organisation listed has specific responsibilities described within the framework.
Chief investigator
The person who takes overall responsibility for the design, conduct and reporting of a study if it is at one site; or if the study involves researchers at more than one site, the person who takes primary responsibility for the design, conduct and reporting of the study, whether or not that person is an investigator at any particular site.
Employing organisation
Organisation employing the chief investigator, investigators or other researchers. Employers remain liable for the work of their employees. The organisation employing the chief investigator normally holds the contract or grant agreement with the funder of the study. Organisations holding contracts with funders remain responsible for the management of the funds provided.
Funder
Organisation providing funding for a study (through contracts, grants or donations to an authorised member of the employing and/or care organisation). The main funder typically has a key role in scientific quality assurance. In any case, it remains responsible for securing value for money.
Investigator
Person responsible, individually or as leader of the researchers at a site, for the conduct of a study at that site. For clinical trials involving medicines, an investigator must be an authorised health professional.
Organisation providing care
Organisation responsible for providing health or social care to patients and/or service users and carers participating in a study. Health and social care organisations remain liable for the quality of care, and for their duty towards anyone who might be harmed.
Participant
Patient, service user, carer, relative of the deceased, professional carer, other employee, or member of the public, who consents to take part in a study. (In law, participants in clinical trials involving medicines are known as subjects.)
Principal investigator
The leader responsible for a team of individuals conducting a study at a site.
Researchers
Those conducting the study.
Research ethics committee
Committee established to provide participants, researchers, funders, sponsors, employers, care organisations and professionals with an independent opinion on the extent to which proposals for a study comply with recognised ethical standards. For clinical trials involving medicines, the ethics committee must be one recognised by the United Kingdom Ethics Committee Authority.
Responsible care professional
Doctor, nurse, social worker or other practitioner formally responsible for the care of participants while they are taking part in the study.
Sponsor
Individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage and finance a study. (A group of individuals and/or organisations may take on sponsorship responsibilities and distribute them by agreement among the members of the group, provided that, collectively, they make arrangements to allocate all the responsibilities in this research governance framework that are relevant to the study.)
Reproduced with permission from the Research Governance Framework for Health and Social Care (England).
If you have developed your own project you will have the responsibilities of ‘chief investigator’ and ‘researcher’ (see Boxes 2.2 and 2.3). The terms ‘chief investigator’, and ‘principal investigator’ need a little explanation. The chief investigator is the person who is leading the research, but if the study is to be carried out over more than one site, each site needs a person ‘in charge’ who is termed the principal investigator. There is always a chief investigator but only multi-centre trials have principal investigators. However, some grant giving bodies refer to the lead investigator as the ‘principal’ rather than ‘chief’, which can get confusing.