Is my study research?

Select the headings below to see definition.

Clinical Audit

Clinical Audit is a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. Aspects of the structure, processes, and outcomes of care are selected and systematically evaluated against explicit criteria. Where indicated, changes are implemented at an individual, team, or service level and further monitoring is used to confirm improvement in healthcare delivery.

Generalisable or transferable

A key feature of research is that it is intentionally planned and designed using documented methodology which will allow results to be extrapolated or applied from the study sample to a larger population. This extrapolation / application is what the terms 'generalisable' and ‘transferable’ refer to. In the case of quantitative research, statistical methods are used to achieve results that are 'generalisable' from a sample to the sampled population. In the case of qualitative research, the context and findings are described and defined so that the conclusions can be applied or transferred to other settings.

This definition involves an attempt at generalisability or transferability, i.e. the project deliberately uses methods intended to achieve quantitative or qualitative findings that can be applied to settings or contexts other than those in which they were tested. The actual generalisability or transferability of some research findings may only become apparent once the project has been completed.

HRA

Health Research Authority

www.hra.nhs.uk

Post Market Surveillance

Post Market Surveillance (PMS) studies of CE marked devices may be classified as service evaluation, where all the following criteria are met:

The product is used unmodified and within its intended purpose;
The assignment of any patient involved in the study to a particular therapeutic strategy or diagnostic procedure is not decided in advance by a protocol but falls within current clinical practice;
The decision to use the product is clearly separated from the decision to include the patient in the study;
No diagnostic or monitoring procedures are applied to the patients included in the study, other than those which are ordinarily applied in the course of current clinical practice; and
Epidemiological methods are to be used for the analysis of the data arising from the study.

If the study does not meet all of these criteria, it should be regarded as research. In particular, any case series study involving additional research procedures (e.g. scans, questionnaires) or additional clinical monitoring should be regarded as research.

Protocol

The research protocol forms an essential part of a research project. It is a full description of the research study and will act as a ‘manual’ for members of the research team to ensure adherence to the methods outlined. As the study gets underway, it can then be used to monitor the study’s progress and evaluate its outcomes.

Randomised

Where people are randomly allocated to receive (or not receive) a particular intervention (this could be two different treatments or one treatment and a placebo). This methodology can provide strong evidence on whether a treatment is effective.

Service Evaluation / Improvement/ Development

Service evaluation is designed and conducted solely to define or judge current care and should answer the question: "What standard does this service achieve?"

It should measure current service without reference to a standard and involve 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 and this should happen before service evaluation). There should be no randomisation.

Service evaluation usually involves analysis of existing data but may include administration of interview or questionnaire.

Service development or improvement seeks to find out what improvement can be achieved within that service only.

It may involve a new intervention or service, or one that is new to that context, but there should be no randomisation and the choice of treatment, care or services is that of the care professional and patient/service user according to guidance, professional standards and/or patient/ service user preference.

Service evaluation / improvement / development work does not require NHS REC review.

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