Additional guidance on lay summaries
Many lay summaries in protocols currently being received by ISAC are considered unacceptable, usually because they are not written in clear, plain English. Since these summaries will ultimately be published, applications whose summaries are not clearly written are not acceptable and will not be assessed until a clear summary in plain English is provided. Specific comments on the summary may also be made by assessors during the assessment process and included in ISAC feedback.
In order to avoid having your application returned to you for this reason, we recommend that you:
- Avoid technical terms as far as possible and explain those which you cannot avoid whenever possible (e.g. diseases and drug names)
- Use simpler alternatives whenever possible
- Define acronyms and abbreviations and make sure they are used very sparingly
- Ask someone else to review your draft summary so as to ensure that it will be clear to members of the public generally
- Exceed the word count of 200
- Go into great detail or attempt to cover every aspect of a complex protocol - rather you should focus on the key objectives and methods at a high level
- Use esoteric or Latin words (e.g. in vivo, a priori)
- Assume acronyms are well known
Examples of a well written and a poorly written lay summary that may be published on the ISAC website or in the guidance
Example of a Model Lay Summary
There is some evidence that zetolol, a medicine used to treat high blood pressure, may rarely provoke systemic lupus erythematosus (SLE), a serious illness in which the immune system attacks various parts of the body (e.g. the skin and kidney). We propose to study this possibility further by using routinely collected health information from the Clinical Practice Research Datalink. We will identify patients who have developed SLE and compare them with otherwise similar people who do not have this illness to see whether or not they are more likely to have used zetolol before its onset. In order to make sure, as far possible, that any differences we may find could be attributable to the medicine we will match patients with and without SLE on various factors such as age, gender and location. The findings of our study are expected to help ascertain whether or not SLE is a rare side-effect of zetolol and, if so, to identify potential risk factors, thereby aiding the development of preventive measures.
Extreme Example of a Poor Lay Summary
*Problematic terms are bolded
There is considerable evidence of a link between smoking and ischaemic events, including myocardial infarctions, cerebrovascular accidents and DVTs. Recent RCTs have demonstrated a reduction in the incidence and prevalence of CVD, CVAs and cancer through the use of NRT. Longitudinal observational studies have shown that NRT cohorts had fewer hospital admissions as a result of chest infections (P<0.05). Reductions in the mortality and morbidity from cardiovascular disease and neoplasms was also observed. There is some concern; however, as nicotine use is associated with an increase in hepatic fibrogenesis. Of interest is how NRT affects hepatic function. By linking the CPRD database to bespoke cancer linkages, mortality data, and HES we will compare changes in liver function in a cohort of NRT users in comparison to controls. A 1:10 matching ratio will be used matching on age, gender and post-code. Read codes for LFTs (ALT, AST, Bilirubin and Alkaline Phosphatase Enzymes) will be used, along with diagnostic codes for liver disease. Patients with a Read code for alcoholism, hepatitis B or C and HIV will be excluded. We will use propensity score matching to determine the effect of the treatment.
Comments on the Poor Summary
In general, acronyms should be avoided. Some acronyms are well known including DNA, HIV and AIDS; however, CVA, CVD, DVTs, RCTs, NRT and HES are unlikely to be understood.
Complex Medical & Scientific Terms:
As with acronyms, scientific terms may be poorly understood by the lay audience. Examples include ischaemic events, myocardial infraction, neoplasms, incidence, prevalence, mortality and morbidity. Statistical terms including P<0.05 and 95 % CI should be avoided, as should reference to a matching ratio. Propensity score matching, or other statistical tests (e.g. T-Test, ANOVA, Kaplan-Meier) should not be used and do not need to be covered in the summary. Specific enzymes in liver function tests (or indeed cardiac tests) do not need to be included in a lay summary, instead you could use liver function test.
Suggested alternative simpler terms:
- CVA - stroke
- CVD - heart disease
- DVTs - blood clots
- Ischaemic events - problems caused by lack of blood flow to an organ
- Myocardial infarction - heart attack
- Neoplasms - cancers
- Incidence - the rate of new cases of disease
- Prevalence - the number of people who have a particular disease
- Mortality - the rate of death
- Morbidity - the burden of disease
- RCTs - clinical trials
- NRT - nicotine based medicines used to help people stop smoking
- HES - hospital based medical records