Influence of Priming on Patient-Reported Outcome Measures: A Randomized Controlled Trial

Claessen, Femke M.A.P.; Mellema, Jos J.; Stoop, Nicky; Lubberts, Bart; Ring, David; Poolman, Rudolf W.

doi:10.1016/j.psym.2015.09.005

Cited by 23 publications

(13 citation statements)

References 25 publications

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“…Clarification of the circumstances in which blinding is important in trials, and an empirical assessment of direction and degree of bias, have important and direct implications for the design of future trials, for interpretation of trial results, and for instructions on how to assess risk of bias when conducting systematic reviews. Clarification is also pertinent to the current debate on the balance between reliability and relevance of unblinded patient reported outcome measures (PROMS),2728 and the relative importance of blinded explanatory trials versus unblinded pragmatic trials 29…”

Section: Discussionmentioning

confidence: 99%

Impact of blinding on estimated treatment effects in randomised clinical trials: meta-epidemiological study

Moustgaard

Clayton

Jones

et al. 2020

BMJ

174

188

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Objectives To study the impact of blinding on estimated treatment effects, and their variation between trials; differentiating between blinding of patients, healthcare providers, and observers; detection bias and performance bias; and types of outcome (the MetaBLIND study). Design Meta-epidemiological study. Data source Cochrane Database of Systematic Reviews (2013-14). Eligibility criteria for selecting studies Meta-analyses with both blinded and non-blinded trials on any topic. Review methods Blinding status was retrieved from trial publications and authors, and results retrieved automatically from the Cochrane Database of Systematic Reviews. Bayesian hierarchical models estimated the average ratio of odds ratios (ROR), and estimated the increases in heterogeneity between trials, for non-blinded trials (or of unclear status) versus blinded trials. Secondary analyses adjusted for adequacy of concealment of allocation, attrition, and trial size, and explored the association between outcome subjectivity (high, moderate, low) and average bias. An ROR lower than 1 indicated exaggerated effect estimates in trials without blinding. Results The study included 142 meta-analyses (1153 trials). The ROR for lack of blinding of patients was 0.91 (95% credible interval 0.61 to 1.34) in 18 meta-analyses with patient reported outcomes, and 0.98 (0.69 to 1.39) in 14 meta-analyses with outcomes reported by blinded observers. The ROR for lack of blinding of healthcare providers was 1.01 (0.84 to 1.19) in 29 meta-analyses with healthcare provider decision outcomes (eg, readmissions), and 0.97 (0.64 to 1.45) in 13 meta-analyses with outcomes reported by blinded patients or observers. The ROR for lack of blinding of observers was 1.01 (0.86 to 1.18) in 46 meta-analyses with subjective observer reported outcomes, with no clear impact of degree of subjectivity. Information was insufficient to determine whether lack of blinding was associated with increased heterogeneity between trials. The ROR for trials not reported as double blind versus those that were double blind was 1.02 (0.90 to 1.13) in 74 meta-analyses. Conclusion No evidence was found for an average difference in estimated treatment effect between trials with and without blinded patients, healthcare providers, or outcome assessors. These results could reflect that blinding is less important than often believed or meta-epidemiological study limitations, such as residual confounding or imprecision. At this stage, replication of this study is suggested and blinding should remain a methodological safeguard in trials.

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Section: Discussionmentioning

confidence: 99%

Impact of blinding on estimated treatment effects in randomised clinical trials: meta-epidemiological study

Moustgaard

Clayton

Jones

et al. 2020

BMJ

174

188

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“…There is some evidence of priming in a single specialty visit. For instance, mental health questionnaires framed in the positive have a positive influence on patient-reported outcome measures (21). And the positive priming in the language of questionnaires also increased grip strength (10).…”

Section: Discussionmentioning

confidence: 99%

What Are the Priming and Ceiling Effects of One Experience Measure on Another?

Salman

Kopp

Thomas

et al. 2020

Journal of Patient Experience

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Patient-reported experience measures have notable ceiling effects which can hinder efforts to learn and improve. This study tested whether an iterative (Guttman-style) satisfaction questionnaire combined with instructions intended to give people agency to critique us primes responses on an ordinal scale and reduces ceiling effects. Among the 161 subjects randomly assigned to complete an iterative satisfaction questionnaire before or after an ordinal scale, there was no difference in mean satisfaction (no priming). The Guttman scale was more normally distributed and had slightly less ceiling effect when compared to the ordinal scale. Iterative satisfaction scales partially mitigate ceiling effects. The absence of priming suggests that attempts to encourage agency and reflection have limited ability to reduce ceiling effects, and alternative approaches should be tested.

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“…Scores range from 0 to 52: A lower score indicates less catastrophic thinking about pain. The patients in the intervention group received a validated positively phrased version of the PCS, for example, "I go about my business, without concern about whether the pain will end" or "I feel I can carry on" 5 (Table 1). Here too, patients answer items on a response scale from 0 to 4.…”

Section: Randomization Intervention and Blindingmentioning

confidence: 99%

“…A study by our group recently found that patients primed with a positively phrased version of the PCS presented less disability on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity when compared with patients primed with a negatively phrased PCS. 5 However, it is not known whether priming also affects performance measurements of hand function. This study addressed the influence of questionnaire content on partially subjective, partially objective performance measurements such as grip strength.…”

Section: Introductionmentioning

confidence: 99%

The Effect of Priming With Questionnaire Content on Grip Strength in Patients With Hand and Upper Extremity Illness

Özkan

Claessen

Eberlin

et al. 2016

Hand (New York, N,Y.)

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Influence of Priming on Patient-Reported Outcome Measures: A Randomized Controlled Trial

Cited by 23 publications

References 25 publications

Impact of blinding on estimated treatment effects in randomised clinical trials: meta-epidemiological study

Impact of blinding on estimated treatment effects in randomised clinical trials: meta-epidemiological study

What Are the Priming and Ceiling Effects of One Experience Measure on Another?

The Effect of Priming With Questionnaire Content on Grip Strength in Patients With Hand and Upper Extremity Illness

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