Writing up research

Writing up your research is as important as undertaking the research itself. It serves as the record of the (hopefully) exhaustive work you have carried out and provides the evidence for your conclusions and interpretations. It is best to anticipate that your paper or thesis should be easy to read by an independent individual who may not have your expertise in the field you are writing about. It should flow, make sense, have structure, and demonstrate originality. Planning your write-up should be considered at the time of planning the project methodology itself, and the process of writing up is best carried out in parallel with the study as it evolves. This chapter will discuss some tips to editing the structure as you go. In general, there is an underlying structure to any write-up, be it a paper in a peer reviewed journal or a thesis. The generally accepted structure is as follows: • Abstract: • Introduction • Methods (or ‘methodology’ or ‘patients and methods’) • Results • Conclusion(s) • Introduction • Methods (or ‘methodology’ or ‘patients and methods’) • Results • Discussion • Conclusion(s) • References or bibliography. These titles are applicable to publications in peer-reviewed journals. Although the structure is universal, the style of write-up is different between writing a paper for a peer-reviewed journal, which requires a clear and concise approach, and a thesis, which needs greater detail. Universities usually have relaxed guidelines regarding the structure of chapters in writing up your thesis (e.g. PhD). However, it is generally advised that however you record your research, the above structure is incorporated into your write-up. For your thesis, there are additional ‘chapter titles’ in the write-up structure you may consider. Below is a comprehensive structured list which, in addition to the core titles (in bold), provides options you may consider to add to your thesis; • Title page • Acknowledgements • Abstract: • Introduction • Methods (or ‘methodology’ or ‘patients and methods’) • Results • Conclusion(s) • Declaration of originality • Table of contents • List of abbreviations • List of tables • List of figures • Introduction • Methods (or ‘methodology’ or ‘patients and methods’) • Results • Discussion • Conclusion(s) • Achievements • Appendices • References/bibliography .

Taking your research career further

Now you’ve completed, and possibly even published your first project, you may experience a gamut of emotions — maybe you’ll be relieved, or maybe you’ll be desperate to do it all again. Whether it’s due to a love of knowledge, or a serious coffee habit you couldn’t accommodate in clinical practice, there’s a chance you’ll want to continue in your new found academic vein. If so, you need to think about how you approach this. Your options range from total immersion in full-time academia to research ‘on the side’ whilst remaining in clinical practice — for most, an option combining the two is best. This can be achieved either by a period of full-time research before re-entering clinical practice, or an academic training post whereby a proportion of your time is protected for academic work. In the rest of this chapter, we’ll look through the options, including for those coming from a non-medical background. Until recently there was no clear route for doctors wanting to pursue an academic career in research. However, in 2005, the Walport Report recommended the integration of periods of research into specific medical training programmes through a process called Integrated Academic Training. Under this system, which has developed over the past few years, a number of postgraduate academic programmes have emerged, providing academic training alongside standard medical training. Although these programmes may appear to be a streamlined process whereby doctors pass from one academic programme to another, in reality there is considerable flexibility in the system. Hence, final year medical students who have done an intercalated BSc, PhD, or MB/PhD and know they want to be academic clinicians may reasonably decide not to apply to Academic Foundation programmes, and rather apply for an NIHR Academic Clinical Fellowship (ACF), and will almost certainly not be disadvantaged through not having held an Academic Foundation post. Whilst there is no doubt that Integrated Academic Training represents a considerable advance in the career structure for doctors wishing to become researchers, these academic posts are very competitive and given the number available most posts are only likely to be awarded to ‘high flyers’.

Evidence-based medicine

The aim of research is to faithfully observe and describe, predict, determine causation, explain the hitherto unexplained, and conjure further questions. Medical research is concerned with the application of the scientific method to investigating both our population at risk, and our patients. However, it is often impossible to study entire populations. Therefore, many studies are undertaken to analyse representative cohorts before extrapolating the data to the population of interest. Every study is susceptible to bias and error. It is important to determine whether the evidence from an individual or groups of studies is strong or weak. In other words, are these data sets truly representative of the entire population of interest, or are the data distorted due to potential confounding factors? Furthermore, have the investigators presented a measured interpretation of their results in the context of the potential errors within their experimental system? It is these questions that have led to the concept of research evidence, or the hierarchical system in which the strength of the argument within some studies is simply better, or more persuasive, than others. When planning a research study, design is the first consideration. The highest possible level of evidence is a systematic review or meta-analysis of randomized controlled trials (RCTs), or an individual RCT. These are considered the ‘gold standard’ of clinical research. The design of RCTs allows exclusion of confounding factors and bias as much as possible. These studies work very well for certain interventions, such as drug trials. However, where the control and sample groups cannot be blinded, (e.g. ‘sham acupuncture’ or ‘sham manipulation’ as the control), RCTs may be less appropriate. Meta-analyses are considered as type 1 evidence. The more data is pooled, the more valid the results. However, the data may be less relevant to individual patients. Therefore, although potentially the most powerful type of evidence, meta-analyses can have some important limitations. A meta-analysis takes a number of trials from the literature, e.g. 10 trials of 100 patients each.

Writing your research proposal

In many ways it’s a reflection of yourself as a researcher and an insight into your proposed work. A poorly written proposal has the ability to wreck a project and embarrass the researcher before it has even begun. Similarly, a well-constructed proposal bodes well for the success of the project and displays the researcher in a good light amongst their peers and supervisors. The research proposal identifies: • What the topic is, both in terms of background and the individual area of interest. • What you plan to accomplish and why it needs doing. • What in particular you are trying to find out, i.e. the research question. • How you will get the answer to your question, i.e. your methodology. • What others will learn from it and why it is worth learning. • How long it will take. • How much money it will cost. Through your research proposal you are attempting to convince potential supporters that your project is worth doing, you are scientifically competent to run it, and are in possession of the necessary management skills to ensure its completion. The proposal concisely describes the key elements of the study process, although in sufficient depth to permit evaluation. It is a stand-alone document that must contain evidence of an answerable question, demonstrate your grasp of the literature, and also clearly show that your methodology is sound. A research time-table is required to demonstrate a realistic appreciation of how the study will progress through time. The research proposal serves many purposes to many different parties. Amongst these purposes, some of the key ones are: • Acting as a route map and timetable for all involved in your project. • Giving a clear overview of your planned work to ensure favourable decision at ethical review. • Gaining funding to carry out your proposed study. • Securing a place to undertake a higher scientific degree. • Being an opportunity to ‘blow your own trumpet’ on paper. Although there are several bodies who will be obliged to see your proposal, there is a reasonable chance it will end up being wider read than this, so a coherent piece of work will reflect well on you.

Ethics

Ethics, as a whole, aim to create a framework upon which complex issues can be thought about and discussed in a reasoned manner. Medical ethics take these reasoned frameworks and apply them to problems that arise within healthcare, often focusing on the doctor–patient relationship. Medical research ethics are very closely related to medical ethics, but look at issues from the researcher–participant perspective. Medical research ethics have come to the fore in the past century with the regulation of medical research, which has focused on safeguarding research participants. The central concern has been to ensure that the interests of society and the researcher do not override the interests of the participant. Prior to the Second World War there was no internationally accepted code of conduct for research involving human subjects. The appalling experimentation carried out by some Nazi doctors led, in 1947, to the publication of the Nuremberg Code. This document outlined ten points that defined legitimate medical research, including voluntary consent and scientific validity. The following year these principles were tied to the Declaration of Geneva. This declaration was a statement of the physician’s ethical duty as a clinician, and has been amended several times since, the latest being in 2006. This declaration was intended as a revision of the Hippocratic oath into a formulation of morals that could be comprehended in the modern world. Following these first steps to create an ethical code for medical researchers came the document that is held to be the authority and basis of medical research ethics. In 1964 the 18th World Medical Association (WMA) General Assembly, held in Helsinki, developed and accepted the Declaration of Helsinki. The document is a statement of ethical principles governing medical research involving human subjects, including research on identifiable human material and data. It deals with the rights and protections of research participants, clearly making the distinction between participants and patients. This is not a legally binding document in international law but draws its authority from the degree to which it has been codified in, or has influenced, national or regional legislation and regulations.

Funding

As it makes the world go round, it is very unlikely you’ll have got this far in planning a research project without someone asking you about money. Unfortunately no research is free — even a project that seems to carry no costs whatsoever will suddenly seem quite expensive when costed by an R&D department. It’s very important, therefore, that you anticipate all costing issues and submit a sensible bid for your project, as it gives you significantly more credibility as someone who knows what they are doing. There are many ‘hidden’ costs of an apparently simple research project. Photocopying of questionnaires is often contentious; although it’s all NHS money for NHS research, the copying will be billed to an individual department and clinical departments with massive running costs are rarely happy to underwrite research costs. Staff planning has to be done exceptionally carefully to ensure that NHS clinical time isn’t being used on the project without permission from someone with sufficient authority to give it. This often does end up being a hidden cost, as the way round it is often simply to fund a session per week to cover the half hour per day spent on the project. These are, of course, just examples. Detailed breakdown of costing points to consider is given later in the chapter; use this section to prepare a good business case and you will impress from the outset. Aside from the fact that you need it to spend on your project, funding is often (maybe unfairly) seen as a guarantee of the quality of your work. The theory that paid-for research will be better peer reviewed than its public sector or charitable equivalent is somewhat naïve, especially when one considers what agendas could underlie commercial research, but it still abounds. The current climate for research funding is confusing but awash with opportunities. The last few years have seen the creation of national funding programmes and prioritized ‘themes’ with some quite substantial budgets, in addition to the traditional sources. The Medical Research Council (MRC) was brought about by Act of Parliament in the early part of the twentieth century, setting aside a penny per working person per year from the National Insurance scheme of the time to fund tuberculosis sanitoria and medical research.

Statistics

Here, we’ll attempt to provide an introduction to what statistics are, some key concepts, and some of the more common tests used in clinical research. It is not a definitive chapter — whole books exist detailing just one of the tests we’ll talk about here and it’s not likely that you have the time or inclination for that! Rather, it is an attempt to help you think about the uses and limitations of statistics and how they might fit into the overall process of your research design. In clinical research much of the data you will collect will be numerical. Collecting the data is, however, just the first stage — then, you have to make sense of it. This is where statistics come into play. The science of collecting and interpreting numerical data, statistics can be used to describe data, such as by calculating averages and distributions ( descriptive statistics) or to draw inferences by analysing patterns and relationships within the data ( inferential statistics). Inferential statistics will usually form the main part of any analysis. Statistical analysis hinges on the use of sampling. In clinical research it is rarely possible to examine whole populations and as a result a sample is drawn from the relevant population. The difficulty with this is that one can never be certain that the sample is representative of the population as a whole and so that some form of bias is not operating. Good experimental design can minimize but not eliminate this possibility; consequently there will always be an element of doubt as to whether a genuine effect is being observed or if we are simply witnessing random variations in a data set. Statistics allow us to analyse patterns within the sample data and to draw inferences about the wider population. One must always bear in mind that statistical tests are used to determine if a prediction we make can actually be supported. They do not provide actual proof that we are correct; if our theory holds up statistically, we are less likely to be incorrect. Equally, if our theory were incorrect the statistics would be unlikely to support it.

Data collection and research conduct issues

A large proportion of this chapter is common sense. We’ll start with the most basic of all — looking after your participants. You have a clear legal, ethical, and procedural duty to do this and events such as Alder Hey demonstrate what happens when the academic good is held to be of higher priority than this. By definition, any participant enrolling in your study is vulnerable, simply by means of a doctor–patient relationship (and a scientist – patient or nurse – patient dynamic can be every bit as uneven). If participants are perfectly physically and mentally well, they are still letting you intrude into their world for the sake of research; in pathological research, of course, patients may be far from well. Take the time to talk to participants, even if they are only giving a few cc’s of blood for a lab project. Was it easy to find you? Do they have any further questions? Was there anything about their encounter they felt could have been better? At the next level, observational studies have potential to create a degree of symptom awareness, so the participant looks harder and harder for a symptom you’ve asked if they have. This can be very hard for them to deal with and they may need reassurance. Your patient information leaflet should have a contact number for your study; larger, well-funded studies sometimes even have on-call clinically trained cover for advice and reassurance. At the highest level, although you won’t be responsible for this in your first foray into research, clinical trials have rigorous requirements for patient and clinician support. Patients will generally carry some kind of identification card with a 24-hour contact number on it, to ensure that advice is available to them or someone treating them whenever it is required. Any kind of adverse clinical event must be reported to the appropriate bodies. Drug reactions must be notifi ed to the Medicines and Healthcare Regulator Agency, in addition to your local R&D department. Any other form of harm, including allegations of it, should be discussed with R&D.

Research design

From the outset, it’s worth highlighting that since the inception of the National Institute for Health Research (NIHR), specialist units now exist to promote good quality medical research by assisting in its design. In England, NIHR Research Design Services (RDS) have been commissioned in eight strategic health authority (SHA) regions, whilst the original Research and Development Support Units (RDSUs) in the other two SHA regions (North West and East Midlands) will continue to provide a similar service. The main purpose of these units is to help researchers develop and design high-quality research proposals for competitions for applied health or social care research. They have been developed with a focus on NHS based researchers applying to the NIHR Research for Patient Benefit Programme, however they also provide advice on other funding schemes. They are also supposed to off er access to a range of expertise in research design, including advice on research synthesis, study design and methodology (quantitative and qualitative), statistics, and economics, and to refer to other sources of expert advice on the applied health and social care research system. In summary these services should be a first port of call for most NHS-based researchers looking to develop a clinical research proposal into a substantial grant application. As many of the regional RDSs have only recently become operational, it is difficult to provide much information on how each RDS works. The general principle, however, is that these services should provide telephone, email, and face-to-face advice to researchers looking to develop a proposal. Many RDSs will provide face-to-face advice in hospitals across their region, or in other sites which should not be too far from where NHS staff are working. These services, which are free of charge, are provided by a variety of individuals with experience of NHS research, statistics, or health economics, some of whom will be active researchers who have been successful with grant applications. A telephone contact number or email address for each RDS can be obtained via the web link: http://www.nihrccf.org.uk/site/programmes/rds/default. cfm . Furthermore each RDS has a website which can be accessed via this link.

Types of research

You have decided on the area you wish to research, reviewed the relevant literature, and developed a research question; your next task is to decide what method is most appropriate to address that question. The first issue you need to consider is whether your study is research or audit. This is important as research and audit, while similar in many respects, have a number of differences that have important ethical, methodological, and management implications. The vogue for ‘call this research project an audit and we don’t need ethics’ is thankfully passing, due not least to intolerance by the General Medical Council (GMC) and National Health Service (NHS) disciplinary panels of such slippery practice. A second issue is broadly methodological, and concerns whether you intend to use quantitative or qualitative methods. Finally, you need to consider whether your research can be done in a clinical setting or is better suited to laboratory conditions, which will have important implications for the manner in which you approach your study. We begin the chapter by considering service investigation and audit and will examine how audit differs from research. Following this we consider quantitative and qualitative approaches and examine their philosophical underpinnings, methods and analysis. Finally we examine basic science concepts and laboratory-based research. For any clinician the main priority in service investigation is the process of auditing one’s own practice. There are, however, other means of evaluating practice. This section will focus in on the assessment of service quality. This, as it turns out, is rather difficult to define. The Department of Health (DoH; 1) defi ne quality as ‘doing the right things, at the right time, for the right people and doing them right — first time’. This, as you may notice, is a rather broad definition which may be of limited value to you when you are planning to use the concept of quality as the central theme of your investigation. However, as this concept of quality is at the centre of pretty much every document the DoH publishes, it is worth keeping it in mind.