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Understanding Clinical Trials and Observational Studies

Clinical Trials & Statistics 05 January 2021 17:04 Different Ways of Studying Diseases/Treatments Session 1 Qualitative Studies · Qualitative Studies Aims to understand more about people's experience of living with a condition · Observational Studies An observational study involves no new treatments & solely the observation of your current state · Interventional Studies Interventional studies involve receiving a new treatment, for example physiotherapy or new drug, to assess the impacts. These studies are generally 'Placebo controlled', 'Double blind' & 'Randomised' This type of research involves being asked questions or having an open discussion. You might be asked questions about anxiety, pain, or doing day-to-day activities. The research team will try to identify patterns to understand the issues faced by people living with disease & ways to tackle them. Can be measured by descriptive statistics, means and medians etc. Benefits Challenges The emotions, perceptions & actions of people who suffer from a medical condition can be understood by qualitative research. Knowing what area & topic is key to ensuring your questions yield usable answers. V Qualitative research is individualized; hence, researchers consider the participants as whole human beings, not as a bunch of physical compartments. * Can be challenging to transform data gained into a statistically robust conclusions. Observation & asking people are the only ways to understand the causes of particular behaviours e.g. can be helpful when develop health or education policies for altering health behaviour. Observation Studies: Cross sectional studies Observational Studies Carried out at one point in time, or over a short period of time. Case-control study Find out who has been exposed to a risk factor & who has developed a specific disease - see if there is a link Exposure Disease Positives - quick & cheap to do Negatives - results can be less useful due to limited time frame Cross-sectional study Exposure Sometimes cross sectional studies done first to find a possible link- then they go on to do a case control or cohort study to look in more detail Disease Target Population Exposed and outcome present Cohort study Exposure Time Disease Study Sample Cather data at one time on both exposure and outcome Exposed and no outcorre Unexposed and outcome present Observation Studies: Cohort Studies Cohort studies follows a specific group over a period of time to determine: 1. who develops a specific disease 2. see whether those that develop that disease have anything in common Can be done prospectively or retrospectively Prospective: 2009 Cohort Unexposed and no outcome 2019 2029 Exposed Occurence of event Non-occurence of event Cohort studies are very useful ways of finding out more about risk factors but they are expensive & time consuming to get results Non. Occurence of Cohort studies are very useful ways of finding out more about risk factors but they are expensive & time consuming to get results Good when it wouldn't be possible to test a theory any other way Observation Studies: Case Control Studies Case control studies work the opposite way to cohort