Planning the study

Research should begin with a question. Many research questions arise from clinical practice and are intended to inform more effective care. Before planning a study, it is important to review what has already been done or is currently being investigated. Searching for related research and project work is an important step in helping to define the purpose of any study. It can also help to identify other possible researchers with whom to collaborate. A research study is a considerable commitment of time and resources. Ensuring that the research question is answerable, valid and relevant to the community is the critical first step.

You can find evidence resources for palliative care in the Evidence and Translation Centre in the CareSearch website. 

RePaDD’s ReSearch tool can help you find PubMed articles on the conduct of research generally or research issues in the fields of palliative care, residential aged care, dementia care, and bereavement.

Consumer input is also valuable in identifying and prioritising research issues, and consumer involvement in planning and managing projects is increasingly expected as part of health research. The NHMRC has released a Statement on consumer and community involvement in health and medical research. Increasingly, consumers are also often involved in determining funding priorities.

A number of resources are available to help support consumer and community participation in research including information for researchers and information for consumers:

• Cancer Voices Australia is the independent, volunteer voice of Australians affected by Cancer This consumer organisation supports and trains consumers to become involved in research and other advocacy for those with cancer. Cancer Voices NSW has produced two Consumer Involvement in Research (CIR) Guides to assist researchers and consumer representatives to work together.
  • Guide for Consumers (243kb pdf)
  • Guide for Researcher (255kb pdf)
• Consumer Guide to Clinical Trials (294kb pdf) developed in conjunction with the Consumer Health Forum.

The NHMRC webpage, Consumer and community engagement provides guidance on a range of issues  and access to various resources including a toolkit for consumer and community involvement in medical and health research.

Research methods need to ensure that valid and reliable answers are retrieved.

Different study designs are required to answer different research questions. Study designs may also reflect historical preferences for ways of doing research within different disciplines. The choice of study design is often affected by pragmatic issues such as funding or patient considerations (eg, pool of potential participants available).

Qualitative research is a naturalistic interpretive approach that seeks to describe and explain how and why people act and make decisions, and how they understand their situation. It may involve transcribing and analysing interviews, or participant observation methodologies.

Quantitative research seeks to identify factors or relationships in a sample that can be assumed to be true of the population from which the sample was drawn. Frequently a study will use mixed methods - that is, a combination of qualitative and quantitative research.

Within these two broad categories, there are many different types of studies. Each has advantages and disadvantages and has its own unique potential sources of bias. One study design is not in itself better than any other. It depends on the question being asked: some studies explore the natural history of a phenomenon or experience, or describe its impact from the perspective of patients or caregivers; others look for protective and risk factors, or causes; some test a new treatment or service to see if it improves the outcomes or experiences of patients; while others try to answer questions about patterns of practice, or of service use, or of adverse effects, and so on.

• Descriptive studies are used to describe the frequency or possible determinants of a condition, or the experience of a condition and/or its natural history.
• Cross-sectional studies are a snapshot at a particular time looking at the presence or absence of a disease or symptom or disease and the presence or absence of an exposure.
• Cohort studies look forward to see if there is a correlation between exposure and an outcome.
• Case control studies look backward to see if an outcome was preceded by a common event such as a disease, symptom or exposure to a material.
• Non-randomised and randomised trials look forward but also compare the effects from a common starting point for two groups.
  • In a non-randomised group, investigators assign participants to a group whereas in a randomised study, participant allocation is by chance. Randomised allocation reduces the likelihood of a systematic variable affecting the outcome.
  • Randomised studies need to be carefully designed so that neither the researchers nor the participants know what treatment the patient is getting - this is called blinding (double blinding when neither knows).
  • Studies in which participants know which treatment they are receiving are called open label studies. Sometimes this is the only method possible, however the results can be very strongly affected by the “placebo effect” - in which patients respond positively to a treatment that they think will be of benefit to them.
  • Placebo controlled trials compare an intervention with a placebo (inactive comparator) so that it is possible to identify whether the intervention is responsible for the outcomes, or whether it is the placebo effect or the natural history of the condition being studied which produces the change. This is important when a condition fluctuates, for instance pain or delirium. When it is ethically feasible, a placebo controlled study of treatments or interventions produces the most reliable conclusions. However, at times it is more ethical and informative to patient care to compare a new treatment with current best practice rather than a placebo.
• Other rigorous study designs that are particularly valuable for some situations in palliative care include n of 1 trials and crossover studies, where a patient tries one treatment and then another or a treatment and then a placebo or vice-versa.
• Studies may also look to synthesise and assess I existing research with systematic reviews and scoping reviews being examples of these types of studies.
• The introduction of technology may also challenge traditional forms of design as business models for development may be used. 
• Some questions relate not to individuals but to populations.
  • Research projects related to these questions may need to access routinely collected information such as cancer registries, census data, and other health related databases.
  • Some research programs might involve establishing a dataset to use for researching particular questions, for example longitudinal studies which follow a group of individuals over a long period of time, disease registries which collect all the cases of a particular disease, or repeated market research surveys which may be able to estimate the prevalence of a particular problem, need, or experience at a population level and over time.

To assess new therapeutic or pharmacological interventions, randomised controlled trials are commonly regarded as the gold standard, particularly where they measure against a control of current practice. 

Useful Resources

• The Centre for Evidence Based Medicine include a web page and downloadable PDF on Study Designs.
• Khalil et al completing a mapping of palliative and end of care research in Australia during 2000 to 2018.
• RePaDD has published a set of blogs on different research methods and methodologies.

A research protocol describes the detailed research plan. Writing a protocol ensures that all the major issues are considered in designing and developing a particular research project. Often the protocol needs to be submitted as part of an ethics submission. Sometimes a protocol is developed by a team of investigators, each one contributing their specific expertise. Protocols may sometimes need to be changed during a project, and a process for managing these amendments is also important, especially when a number of people or sites are involved in a study.

A protocol includes a background which summarises the evidence about the issue in the literature and provides a justification for doing the study, explaining the significance of the issue. It describes the participants and the inclusion and exclusion criteria, as well as how they will be recruited. Quantitative studies such as clinical trials describe the hypothesis and outcome measures, and then under the heading of study methods describe the intervention and how the study will be done. Protocols for qualitative studies describe in detail the processes that will be used to investigate the question.  Prospero registers protocols for systematic reviews, rapid reviews and umbrella reviews.

Other issues that are addressed in a protocol are how the data will be analysed - quantitative studies need to specify the sample size, which is a statistical estimate of the number of participants needed to answer the research question within a specified degree of probability. This is described as the statistical power of the study. Some studies also have a health economics component, and this is also described in the protocol. Finally, a protocol needs to address issues of feasibility – that is, whether the study design is actually able to be completed in a particular setting, or with given resources, or in a certain timeframe. A number of draft protocols are available online to assist researchers. The World Health Organization’s Research Ethics Committee has a recommended format for a research protocol. A number of state health departments have produced research protocol templates that need to be submitted when seeking ethics for human research in their services.

Writing a protocol is a key skill for researchers. Research Centres and health services  often provide protocol development workshops, and these can be extremely valuable for new and experienced researchers alike. At these workshops, researchers present a draft of either a protocol or a research concept, and experienced researchers provide them with advice and input. These organisations may also help junior researchers to access statistical advice during the planning stages, which can be very valuable. Having access to feedback from experienced researchers can be  daunting but can also make an enormous difference to the ultimate quality of the research, and help ensure that problems are identified early. It also makes it more likely that a study will be able to go forward for funding, and can help new researchers locate others with expertise who can help with their study in many different ways.

It is becoming more common for large scale trials to publish their protocol to inform the community of the study and to ensure transparency in the planning and conduct of the trial.  There are specific journals which focus on publishing protocols. Other journals have protocols as a particular article type or allow the research protocol to be uploaded as a supplementary file for the trial publication.

Feasibility

A study is feasible if it is:

• able to be completed within the proposed timeframe and resources
• supported by the organisation where it is being undertaken
• the methodology is able to be implemented (eg, sample size and outcome data collection).

A pilot study is the best way to clarify issues of feasibility, and provides very valuable data to help plan the statistical analysis. Trialling the whole research process can ensure that the final study is workable. Audits of the type of data that are to be used in a study are another process which may be valuable in preparing for a study.

Another important reason to do a pilot study as the first phase of a research process is that being able to provide data from a pilot study significantly improves the chances of attracting research funding; indeed, bodies like the NHMRC usually require pilot data before funding a larger project.

Research processes

Implementing a research protocol involves working out in advance every step of the data collection process, how it will be documented, and how it will then be recorded and analysed. The exact processes will vary according to the nature of the study, but many issues are likely to be common to all research.

The consent process is crucial, and there are some special considerations in palliative care. How patients will be contacted and by whom, how the study will be promoted, and what written information about the study is required as part of the consent process, will all be part of the ethical approval for the study. The practical aspects should be carefully thought out.  Legislation related to consent varies in different states.

Studies in which the participant may have impaired ability to consent, for instance studies relating to delirium, may need a proxy to consent as well as consent from the patient. Studies involving children usually require consent from the child and a parent/guardian. In other studies related to symptoms or care of patients who are close to death, for instance studies related to terminal secretions, participants may sometimes be asked to pre-consent before they enter the terminal phase.

Data collection processes usually involve designing a document to complete with the data collected for each subject. This is often called a Case Report Form or CRF. The CRF should be planned with the subsequent data analysis process in mind - to make the next steps of coding and data entry as efficient as possible. Piloting the CRF can be extremely useful.

If the research process uses interviews, the process for documenting and coding these must be considered as the protocol is being developed. If questionnaires are used, how they will be given to the participants, how and when they will be completed, and how they will be returned, must be detailed. The administrative burden for studies involving questionnaires (printing, mailing etc,) may be significant. Sometimes access to a list of addresses may be required for mailing of questionnaires, and there may be privacy and ethical barriers that make this difficult.

Having the written support of a supervisor or the endorsement of a professional body may make this easier to negotiate. Special thought needs to be given to open surveys such as those distributed through other bodies or online. Maximising response rates and reducing the danger of bias from a ‘volunteer effect’ should be considered in planning.

If participant assessments are to be performed – eg, related to problem severity or changes in symptoms, or effects of a treatment, or if the planned interviews are likely to cover sensitive or emotional issues - the skills and experience of the research staff need to be appropriate for these tasks. Sometimes researchers need to consider what they will do if a participant is very distressed or has symptoms that need follow-up (ie, who they may refer to in that situation, and whether they need the participant’s consent to do so) but also the possibility of interviewers being distressed or needing someone to debrief with may be important to consider as well, depending on the nature of the research question.

If access to patients’ medical records is required, the logistics of this will need to be carefully thought about and negotiated.  State and health service requirements about confidentiality and access to case notes are generally very stringent, and gaining access to some types of information may be difficult, especially if the researcher is not employed within that health service.

Coding and data entry are crucial steps in the study processes. Allowing enough time for these is essential. Considering how they will be done is also important. Generally, when qualitative studies are coded, more than one coder is involved, and interviews are transcribed. This is an important cost to budget for and early identification of a research team to share the coding is necessary. If it is a quantitative study, how and by whom data will be entered, and the security of the data, are essential questions to answer.

Piloting the coding frame and documenting key definitions and coding decisions is invaluable to ensure that the quality of the data is reliable, and that problems can be identified early on.

Storage of research data

There is a legal requirement to retain research documents, and also the medical records of patients who have participated in clinical trials. The length of time varies according to the type of study - but may be for as long as 20 years. Access to safe and secure archive facilities is therefore required. Electronic data requires specific consideration with regard to storage and security. Ethics committees may expect detailed information about how and where records will be stored, both during and after the study.

Funding has an inevitable influence on research. While some research studies can be carried out within existing resources, others require additional financial and human resources. The amount of available funding for the research may also shape the study. It is important to know that there are sufficient funds to undertake a meaningful study for the research purpose. Concerns have been raised about underpowered studies.

There are various sources of funding. Many institutions offer internal grants and awards that can support pilot or exploratory research work. There are philanthropic bodies that provide funds for research and projects. Other organisations such as Cancer Councils raise funds for research purposes. The Australian Government provides significant research funds through its formal agencies, the National Health and Medical Research Council (NHMRC) and the Australian Research Council (ARC). State and territory governments also commit funds for research. There are various international sources of research funding.

GrantConnect provides a centralised publication of forecast and current Australian Government grant opportunities and grants awarded.

Writing a grant is a substantial time commitment. Identifying suitable grants, making yourself familiar with the requirements of the specific grant round, establishing the research team and developing the study design and budget are just some of the grant tasks. Remember the granting body has designed the grant round to achieve certain purposes. Your grant application should address the grant purpose.  

Developing grant proposals can be time consuming, so it is important to set aside adequate time to ensure applications can be finalised by funders’ due dates. If funding is going to be managed by a University, it is not uncommon for an infrastructure levy to be charged for some types of grants. They will also require additional time to sign off on grant applications, usually at least a week, which must be taken into account when looking at the timelines for application writing.

The following resources may be useful in preparing requests for research funding:

• University of Adelaide’s Research Services has a section on writing grant applications.
• Elsevier’s Funding page has a series of modules and guidance on writing applications.