Performance bias

Systematic differences in the care provided to members of different study groups other than the intervention under investigation

Background

Performance bias is specific to differences that occur due to knowledge of interventions allocation, in either the researcher or the participant. This results in differences in the care received by the intervention and control groups in a trial other than the intervention that are being compared. For example, participants in the control group might seek other treatments, or researchers/clinicians might treat participants differently depending on which group they are in. This bias may inflate the estimated effect of the intervention, particularly in trials with subjective outcomes.

Example

Performance bias often occurs in trials where it is not possible to blind participants and/or researchers, such as trials of surgical interventions, nutrition or exercise. For example, a systematic review of trials of physical activity for women with breast cancer after adjuvant therapy found that all the included trials were at high risk of performance bias because the nature of the intervention (i.e. physical activity) made it impossible to blind trial personnel and participants, and because the main outcomes were subjective.

A qualitative study assessed the risk of performance bias in a weight-loss trial of a novel patient counselling programme compared to usual care in general practice. The control group reported being disappointed at having been offered usual care when they had taken part in the trial. Reactions to disappointment involved both movements toward and away from behaviour change. The researchers concluded that disappointment may introduce bias, as they lead the randomized groups to differ in ways other than the intended experimental contrast.

Impact

A systematic review assessed the effect of the lack of double blinding (of both participants and researchers) on intervention effects. It concluded that compared to studies with clear double-blinding, studies with a ‘lack of, or unclear double-blinding’ yielded effect estimates, on an average, 13% (ROR 0.87, 95% CrI 0.79 to 0.96). The review authors also concluded that studies with subjective outcome assessment (such as pain) were more prone to the adverse effects of lack of blinding (ROR 0.85, 95% CrI 0.75 to 0.95).

Preventive steps

Ideally, participants and researchers should be blinded to the interventions. If blinding is not feasible, the effect of performance bias can be mitigated by using objective outcomes. For instance, a subjective outcome such as patient-reported pain is more likely to be influenced by performance bias than an objective measure, such as hospital admission.

If subjective outcomes are used in a trial, performance bias can be mitigated by blinding the outcome assessor. For instance, in a trial assessing the effect of cognitive behavioural therapy (CBT), the researcher who delivers the intervention (who cannot be blinded), should be different to the researcher who assesses the patient-reported outcomes.

Sources

Lahart I, et al. Physical activity for women with breast cancer after adjuvant therapy. Cochrane Database Syst Rev. 2018 Jan 29;1:CD011292.

Porta M. A dictionary of epidemiology. Oxford University Press. 2014

Savović J et al. Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials: combined analysis of meta-epidemiological studies. Health Technol Assess. 2012 Sep;16(35):1-82.


These sources are retrieved dynamically from PubMed

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