Guidance for writing the clinical bottom line

 

The strength of evidence provided by a study type is dependent upon the clinical question being addressed as indicated in Table 1. It is also dependent upon how well the study was designed and implemented. Factors to be considered in the study design may include the sample size, bias, blinding, control of variables, appropriate use of statistical tests, the power of the study, the accuracy and precision of any measurements made, the sample population and other components that may reduce the strength of evidence provided by the study.

When composing the clinical bottom line it is important that the strength of the body evidence provided by the studies is assessed and categorised according to Table 2 below. The outcomes from the studies should then be clearly stated. Conclusions and additional comments based upon the strength of evidence and the outcomes reported should then be made.

 

Table 1: Level of evidence table, adapted from the Oxford Centre for Evidence-Based Medicine’s levels of evidence

Strength of evidence

Clinical question being addressed

Treatment

Prognosis

Risk

Diagnosis

Prevalence

Incidence

1 (strongest)

Systematic review and meta-analysis

Systematic review and meta-analysis

Systematic review and meta-analysis

Systematic review and meta-analysis

Systematic review and meta-analysis

Systematic review and meta-analysis

2

Randomised controlled trial

Cohort study

Cohort study

Diagnostic test evaluation study

Cross-sectional study

Cohort study

3

Cohort study

Case-control study

4

Case report or case study

Case report or case study

Case report or case study

Case report or case study

Case report or case study

Case report or case study

5 (weakest)

Opinion consensus

Opinion consensus

Opinion consensus

Opinion consensus

Opinion consensus

Opinion consensus

Modified from Rees Gwen (2019)

Table 2: Significance of the four levels of collective evidence used in the clinical bottom line

Strength of evidence provided by the study designs

Definition

Strong

High level of confidence that the estimate of the effect reported by the studies lies close to the true effect. 

Moderate

Moderate confidence that the estimate of effect reported by the studies lies close to the true effect. 

Weak

Limited confidence that the estimate of effect reported by the studies lies close to the true effect.  Additional appropriate studies are required.

Zero

No studies available.

Modified from Balshem et al (2011)

When writing a Knowledge Summary, authors will be asked to fill in the below section within the submission template:

Figure 1: Clinical bottom line submission template

Question

 (In PICO format)

 

Clinical bottom line

 

  • The category of research question was treatment/prognosis/risk/diagnosis/prevalence/incidence

Indicate the category of research question that was addressed

  • The number and type of study designs that were critically appraised were…

Indicate the number and type of study designs which were critically appraised

  • Critical appraisal of the selected papers meeting the inclusion criteria collectively provide zero/weak/moderate/strong evidence in terms of their experimental design and implementation.

Indicate the strength of evidence

  • The outcomes reported are summarised as follows…

Indicate the summarised collective outcome(s) from the studies

  • In view of the strength of evidence and the outcomes from the studies the following conclusion is made…

The conclusion should provide an answer to the Knowledge Summary question

Additional comments and caveats can be added if required

 

 

Below is an example using the Knowledge Summary by Natasha A Jocelyn (2018) (http://dx.doi.org/10.18849/ve.v3i2.139).

Figure 2: Example of completed Clinical bottom line

Question

In an Adult Horse With Severe Asthma (Previously Recurrent Airway Obstruction) Does Using Inhaled

Corticosteroids Result in an Equal Improvement in Clinical Signs When Compared to Systemic

Corticosteroids?

 

Clinical bottom line

  • The category of research question was treatment/prognosis/risk/diagnosis/prevalence/incidence

Treatment.

  • The number and type of study designs that were critically appraised were…

Four papers were critically reviewed. There were 3 prospective crossover design clinical studies and a randomised design clinical study.

  • Critical appraisal of the selected papers meeting the inclusion criteria collectively provide zero/weak/moderate/strong evidence in terms of their experimental design and implementation.

Strong.

  • The outcomes reported are summarised as follows.

Inhaled corticosteroids (fluticasone and beclomethasone) when used at an appropriate dose can

have equivalent effects on severe equine asthma as systemic intravenous dexamethasone. Inhaled

corticosteroids can take longer to have the desired effects.

  • In view of the strength of evidence and the outcomes from the studies the following conclusion is made…

In an adult horse with severe asthma (previously recurrent airway obstruction) inhaled

corticosteroids result in an equal improvement in clinical signs when compared to systemic

corticosteroids.