Placebo, Nocebo, and Patient-Reported Outcome Measures in Drug Allergy

Bavbek, Sevim; Özyiğit, Leyla Pur; Baiardini, Ilaria; Braido, Fulvio; Roizen, Gigia; Jerchow, Elina

doi:10.1016/j.jaip.2022.11.033

Cited by 4 publications

(3 citation statements)

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“…40 In drug allergy, the nocebo effect is an important issue, which has been recently reviewed. 41 In adults, it is the main reason for false-positive reactions during a DPT, which is well known and studied because the test is frequently performed by DBPC, making it possible to distinguish when the patient's expectations influence the test result and thus the true positives (hypersensitivity reaction caused by the administered drug) from false positives (nocebo effect). [42][43][44][45][46][47][48] Reactions to a nocebo effect are usually subjective (e.g.,…”

Section: Patient and Family E Xpec Tati On S: The No Cebo Effec T In ...mentioning

confidence: 99%

“…The counterpart to the placebo effect is the nocebo effect: the occurrence of a harmful response or effect following the administration of an inert treatment or the performance of a sham test 40 . In drug allergy, the nocebo effect is an important issue, which has been recently reviewed 41 . In adults, it is the main reason for false‐positive reactions during a DPT, which is well known and studied because the test is frequently performed by DBPC, making it possible to distinguish when the patient's expectations influence the test result and thus the true positives (hypersensitivity reaction caused by the administered drug) from false positives (nocebo effect) 42–48 .…”

Section: Patient and Family Expectations: The Nocebo Effect In Dptmentioning

confidence: 99%

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Drug provocation tests in children: All that glitters is not gold

Moral,

Mori

2023

Pediatric Allergy Immunology

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A proper allergy work‐up, based on the gold standard drug provocation test (DPT), usually rules out suspected drug hypersensitivity in children. These tests are generally open, given their high efficiency compared with double‐blind placebo‐controlled DPTs. Although their negative predictive value is excellent, no studies have calculated their positive predictive value, highly dependent on the prevalence of the disease. Most studies have found a rate of <5%–10% of true beta‐lactam hypersensitivity in children. Given this low prevalence (pre‐test probability), a few false‐positive results can significantly reduce the estimated positive predictive value. False positives may arise from the nocebo effect during the test, including nocebo by proxy, or from observer bias, which depends on professional expertise and organizational circumstances. Some studies have found a high rate of tolerance on a second DPT in children who failed the first, but these results may be affected by the interval between the two tests, of a year or more in most cases, reflecting a loss of hypersensitivity over time. Taking into account the low rate of positive DPTs, with commonly mild reactions, we suggest confirming nonsevere positive DPTs with a second provocation performed soon after the first, especially in the case of beta‐lactam antibiotics, in order to improve the diagnostic accuracy, de‐label more patients, and achieve a better estimation of true drug hypersensitivity prevalence. In case of mild immediate reactions, the potential benefits of a second DPT should be carefully weighed against the risk of anaphylaxis.

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Section: Patient and Family E Xpec Tati On S: The No Cebo Effec T In ...mentioning

confidence: 99%

Section: Patient and Family Expectations: The Nocebo Effect In Dptmentioning

confidence: 99%

Drug provocation tests in children: All that glitters is not gold

Moral,

Mori

2023

Pediatric Allergy Immunology

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“…Delabeling of incorrect PA is safe and can lead to reduction in nonpenicillin antibiotic use, improved clinical outcomes, as well as reduction in future healthcare costs [ 5 – 10 ]. Despite a myriad of detrimental effects associated with PA, there have been surprisingly few studies focusing on patient-reported outcomes (PROs) such as health-related quality of life (HRQoL) and disease perception [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

Validation of the Chinese drug hypersensitivity quality of life questionnaire: Role of delabeling

Mak

Chan

Yim

et al. 2023

Asia Pacific Allergy

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Background: The Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q) is not currently available in Chinese. Besides, penicillin allergy (PA) is a worldwide public health challenge, and delabeling inauthentic PA can improve clinical and economic outcomes. However, its effect on health-related quality of life (HRQoL) remains poorly known. Objective: The study objective is to translate and validate a Chinese version of DrHy-Q and investigate the effect of PA delabeling on HRQoL using DrHy-Q. Methods: A Chinese DrHy-Q was translated then completed by patients with drug allergy labels for psychometric validation. Afterwards, another cohort of patients finished the Chinese DrHy-Q before and after their PA workup for pre–post comparison. Results: A total of 130 patients were studied. Sixty-three patients (79.4% female; median age = 59 ± 15 years) completed the Chinese DrHy-Q for validation (mean score = 38.9 ± 23.5). It demonstrated excellent internal consistency (Cronbach α = 0.956; 95% confidence interval [CI], 0.939–0.971) and test–retest reliability (intraclass correlation coefficient = 0.993 [95% CI, 0.969–0.998]). Construct validity was confirmed by its one-dimensional structure in factor analysis. Divergent validity was established because only 2 (out of 9) SF-36 scales showed weak negative correlations to DrHy-Q. Patients with multiple implicated drugs presented significantly higher DrHy-Q scores than those with only a single drug (42.0 ± 22.5 vs 28.7 ± 24.4; P = 0.038), showing discriminant validity. Subsequently, another 67 patients (73.1% female; median age = 56 ± 15 years) underwent PA investigations and completed their pre–post DrHy-Q. A significant drop in DrHy-Q score was shown (40.8 ± 21.7 vs 26.6 ± 22.5; Cohen’s d = 0.964; P < 0.001), reflecting improvement in HRQoL. Conclusion: The Chinese DrHy-Q is reliable and valid for HRQoL assessment. PA delabeling significantly benefits patients’ HRQoL. Future larger-scale studies are warranted to corroborate our findings.

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