Choosing the right research question is the cornerstone to undertaking quality and successful research. It might come from an area of clinical uncertainty you have encountered, an emerging knowledge area not yet served by previous research, or you may have a senior mentor - either clinical or academic - who suggests an area in need of investigation. Having a senior research mentor will facilitate the process and it is important that you find someone in your wider community or look to professional organizations to support your research endeavors. IUGA is a great place to start if you need help finding a mentor local to you.
Without a well-focused question, it can be very difficult and time consuming to identify appropriate resources and search for relevant evidence. Practitioners of Evidence-Based Practice (EBP) often use a specialized framework, called PICO, to form the question and facilitate the literature search. PICO stands for:
- Patient Problem, (or Population)
- Comparison or Control
Once you've decided on the question you would like to answer, it is important to make sure that it has not already been answered. This can be done using a literature search, often involving multiple databases. Your hospital or local educational institution may offer you access or perhaps even library services where professional librarians can undertake searches on your behalf. If you do not have access to this resource, Pubmed and Google Scholar are good places to start. To ensure you find the right studies you will need to use specific search terms known as field codes and Boolean operators. A guide to undertaking searches may be provided by your library. Additionally, this article gives a good introduction to undertaking a literature search.
A successful grant application requires:
- Clearly justifying your research
- A concise research question
- An appropriate and feasible methodology. A helpful guide is provided by the Wellcome Trust and can be found by clicking here.
IUGA funds urogynecological research. Ensure you review links for eligibility criteria, award details, due dates, etc.
- International Urogynecological Association (IUGA) Research Grants
You must choose a design that appropriately answers your objective. When you have a finalized protocol or proposal, you will be ready to submit this to your institutional review board or local ethics committee. It is essential that you choose the right methodology to allow you to answer your research question to the best of your ability. Broadly there are the following research methodologies for observational studies:
- Cohort study: Studying a group of people with a shared ‘exposure’. This may be retrospective (for example, you may review a group of participants who have already undergone a particular type of surgery) or prospective (for example, you may follow-up a group of participants who are planning to undergo a particular type of surgery). Prospective studies are generally more informative as you will state the 'outcomes' that you wish to study in advance, therefore reducing the risk of introducing bias into subsequent analyses. They are particularly good for establishing causality due to their temporal nature, as well as identifying the 'rate' or 'incidence' of various outcomes related to an exposure.
- Case control study: Similar to a cohort study, however a 'control' group is also studied for comparison. This group will come from the same population as the group which is subject to your 'exposure' of interest. Case control studies are good for quickly defining the relationship between background variables, exposures, and your chosen outcomes.
- Randomized-controlled trial: a more 'rigorous' form of research that requires prospective recruitment of participants, who are either 'exposed' or 'not exposed' to an intervention of interest. For example, you might compare one drug for overactive bladder to another, or to a placebo. Prospective data collection, pre-stated outcomes and randomization all reduce bias allowing for more meaningful results. These are typically the most resource intense and longest studies to undertake due to the nature of their design, however they also yield the highest quality data.
Choosing an outcome measure is a key part of designing your research. An outcome is the result or effect that you will be measuring to determine if an 'exposure' influences your study participant. To ensure standardization of outcomes (allowing for meta-analysis and meaningful comparison), the CROWN initiative is working on agreed outcomes for women's health research. For patient reported outcomes (PROMS), various questionnaires have been assessed for validity by the International Continence Society and can be found in the 'Incontinence' publication.
Other resources for assistance in study design are listed below.
Designing Clinical Research, Chapter 3: Choosing the Study Subjects: Specification, Sampling, and Recruitment
Studies require analysis of data characterizing patients and their outcomes. Collecting data in an organized, systematic fashion is essential. There are many ways to store data. IUGA members have access to a Surgical Data Collection system to track their own outcomes.
Existing datasets are available which compile information from multiple institutions, professional organization members, or national registries. Existing datasets can provide a large sample with extensive information to characterize patients and measure outcomes. IUGA members can access the IUGA surgical database for opportunities to use a larger dataset.
Ethics and Institutional Review Boards
Before initiating your study, it’s essential to check with your institutional board to make sure you have approval to proceed. Globally, disseminated research should have a statement regarding approval from an institutional or ethics review board (or a statement of exemption from review). The requirements and rigor of review may differ by region or institution.
There are papers and checklists that provide recommendations for ensuring quality in your study design. Review of these guidelines and checklists is recommended prior to initiating your study.
Note: Before embarking on the process of obtaining ethical approval, first check if it is needed as for some retrospective studies, registration at your hospital as an 'audit' may be all that is necessary.
Registration of your Study: Avoid Duplication
Designing and conducting a study is a great deal of work. Registering your study helps to avoid duplication. Registration can be done at many stages, but ideally is done prior to study initiation. Ethics/Institutional review boards may want to know if this is a registered study and registration information may be included during the informed consent process.
Here are examples (not an all-inclusive list) of registries across the world. Search for the registry that is most appropriate for your study design and region.
Australian New Zealand Clinical Trials Registry (ANZCTR)
It is important to have a qualified statistician to analyze your data. It is also important to have some baseline understanding of how to analyze data. Below is a link to help learn basic information about statistics for clinical research (simply summary of concepts) and a book which may be helpful.
Writing your manuscript can be daunting, but here are a few tips that can help ease the burden. First, you should choose the journal to which you plan to submit your work, as they all have slightly different requirements, focus points, and impact factors (which are used as a marker of their quality and readership). Your mentor can guide you on an appropriate journal to select. Once you have a journal in mind, try to find an article published in that journal which has used the same research methodology as you are planning, and even better, a similar topic area as your research. Such an article can serve as a guide on what you need to include and how to present your data. Consider writing your methods first, then results, and finally the abstract. Here are some resources on writing a manuscript:
How to Read and Write an Article, IUGA Podcast
Publishing your manuscript and presenting at professional conferences will share your findings. Presenting at a conference could take form in any one of the multiple types of presentations (poster, oral, video). To be considered for presentation, you must submit an abstract to the conference, and, as such, timing is important. Many conferences ask that authors do not submit their manuscript for publication until after the abstract has been accepted to present. Be sure to review the guidelines for conferences to which you submit your abstract.
Advice for Creating & Delivering Your Presentation
Dr. Rufus Cartwright & Dr. Linda Brubaker provide advice on presenting your work as well as career development advice in this webinar.
Promoting Work on Social Media
Sharing a concise summary of your research on social media increases visibility. Be sure to check with the journal in which you publish; this service may be provided for you. It is important to check on publisher copyrights to know when during the production timeline you may share your work.
It is difficult to post a full manuscript on social media. Many peer reviewed journals have adopted visual abstracts as a method to disseminate research. Visual abstracts are a summary of key points from an article. Here are links with information about visual abstracts.
Co-authors take part in writing parts of a manuscript; but co-authors also provide important feedback on parts of the manuscript which they have not written. If manuscripts are submitted to a peer-reviewed journal, authors receive valuable feedback that can significantly improve the quality of the manuscript.
Critical appraisal of existing, published work is an important skill to have. It is important to search existing literature prior to designing your own study, and equally important to critically evaluate the existing literature. The link below provides a set of eight critical appraisal tools designed to be used when reading research and include tools for Systematic Reviews, Randomized Controlled Trials, Cohort Studies, Case Control Studies, Economic Evaluations, Diagnostic Studies, Qualitative Studies, and Clinical Prediction Rule. The site also provides a checklist you can use once you have designed your study to ensure that it is robust.