Drug Hypersensitivity Quality of Life Questionnaire: validation procedures and first results of the Portuguese version.

BACKGROUND: Hypersensitivity reactions to drugs are unpredictable and can be very complex and severe, even life threatening. Assess its impact on patient's health related quality of life (HRQoL) is crucial. The Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q) is the only validated disease-specific HRQoL questionnaire. We aimed to translate and cross-cultural validate the DrHy-Q to the Portuguese population. It was also our purpose to determine the impact of drug hypersensitivity on patients' HRQoL. METHODS: The translation and cross-cultural adaptation of the DrHy-Q to Portuguese was performed according to standards. Reliability of the DrHy-Q Portuguese version was assessed in terms of internal consistency and test-retest reliability. Structural validity, divergent validity (with a generic health related QoLQ-PGWBI) and discriminant validity were also evaluated. Forty patients accepted to participate in the validation phase. The Portuguese version of the DrHy-Q was applied to 260 consecutively adult patients, studied in our Department for suspected drug hypersensitivity. RESULTS: The Portuguese DrHy-Q showed adequate internal consistency (Cronbach's ɑ = 0.938), good test-retest reliability [ICC = 0.713 (95% CI 0.488-0.850] and one-dimensional structure. No significant correlation was found between the DrHy-Q and the PGWBI total scores (r = - 0.010, p = 0.957). Two hundred of patients completed the study: 78.5% female; mean age = 44 ± 15 years. Mean DrHy-Q score was 36.8 ± 12.6. Two clinical factors significantly predict DrHy-Q total score: clinical manifestations and number of suspected drugs. Patients with anaphylaxis (ß = 11.005; 95% CI 5.523; 16.487), urticaria/angioedema (ß = 7.770; 95% CI 2.600; 12.940) and other manifestations (ß = 7.948; 95% CI 1.933; 13.962) are more likely to have higher DrHy-Q total score than patients with maculopapular exanthema. Patients with ≥ 2 suspected drugs are also more likely to have worse QoL (ß = 7.927; 95% CI 3.687; 12.166). CONCLUSION: The Portuguese version of DrHy-Q revealed adequate validity and reliability, indicating that it is appropriate to assess the impact of drug hypersensitivity on patients' HRQoL, providing data for a better comprehension and management of our patients. Moreover, our results highlight that the severity of the drug hypersensitivity reaction and the number of suspected drugs have impact on patient's DrHy-QoL.

Quality of Life in Patients with Allergic Reactions to Medications: Influence of a Drug Allergy Evaluation.

BACKGROUND: Suspicion of allergic drug reaction can cause important disturbances in the patient's life. OBJECTIVE: We evaluated in a prospective multicenter study the quality of life of patients who suffered a possible allergic drug reaction, and analyzed the effect of a drug allergy evaluation. METHODS: Patients (>18 years old) answered the specific questionnaire twice: before the drug allergy evaluation, and 1 month after it was completed. Statistics were performed using STATA. RESULTS: A total of 360 patients (240, 66.6% female; mean age, 45.4 years; standard deviation [SD], 15.6 years) completed the first questionnaire. After the evaluation, 150 of 346 patients (43.4%) were diagnosed as allergic to the drug (115 of 150 immediate; 35 of 150 delayed) and 196 of 346 patients (56.6%) as nonallergic. The mean value of the first questionnaire was 32.14 (SD, 11.84); patients with anaphylaxis, nonanaphylactic immediate reaction, with more than 1 drug reaction, or a chronic osteoarticular disease, had a statistically significant higher score in Q0 (worse quality of life). After the allergy study, the mean of the second questionnaire was 27.27 (SD, 9.96), showing a global improvement (P < .001). No statistically significant difference was found between drug allergic and non-drug allergic patients (P = .340); however, being >40 years old (P = .030), having a chronic osteoarticular disease (P = .003) and having more than 1 reaction to drugs (P < .001) were associated with a statistically significant worse quality of life after the evaluation. CONCLUSIONS: Having suffered anaphylaxis, more than 1 reported drug allergy or presenting a musculoskeletal disease are factors that worsen the quality of life. Quality of life improved significantly after completing a drug allergy evaluation.

Reported Knowledge and Management of Potential Penicillin Allergy in Children.

BACKGROUND: Pediatric emergency medicine (PEM) and primary care provider (PCP) providers are the most likely physicians to initially label a child as allergic to penicillin. Differences in knowledge and management of reported penicillin allergy between these 2 groups have not been well characterized. METHODS: A cross-sectional, 20-question survey was administered to PEM and PCPs to ascertain differential knowledge and management of penicillin allergy. Knowledge regarding high- and low-risk symptoms for true allergy and extent of history taking regarding allergy were compared between the 2 groups using t tests, Chi-square, and Wilcoxon tests. RESULTS: In total, 182 PEM and 54 PCPs completed the survey. PEM and PCPs reported that 74.1 ± 19.5% and 69.0 ± 23.8% of patients with remote low-risk symptoms of allergy could tolerate penicillin without an allergic reaction. PEM and PCPs incorrectly identified low-risk symptoms of allergy as high-risk, including vomiting with medication administration and delayed skin rash. PCPs took more detailed allergy histories when compared with PEM providers. In total, 143 (78.5%) of PEM providers and 51 (94.4%) PCPs were interested in using a penicillin allergy questionnaire to segregate children into high- or low-risk categories. CONCLUSIONS: Most pediatric providers believe that children with a remote history of low-risk allergy symptoms could tolerate penicillin without an allergic reaction; however, this is infrequently acted upon. Both PEM and PCP providers were likely to classify low-risk symptoms as high-risk and infrequently referred children for further detailed allergy assessment. Both groups were receptive to decision support measures to facilitate improved penicillin allergy classification and labeling and support antibiotic appropriateness in their patients.

Penicillin Allergy Maybe Not? The Military Relevance for Penicillin Testing and De-labeling.

INTRODUCTION: Penicillin allergy is the most common drug allergy reported. About 8-10% of individuals in the USA have a documented penicillin allergy, yet 90% are not truly allergic to penicillin. A penicillin allergy "label" results in increased antibiotic-related adverse reactions and increased health care costs, thus impacting the overall "readiness" of the military. MATERIALS AND METHODS: A review of the current literature and approaches to penicillin allergy and "de-labeling" a patient who reports penicillin allergy was conducted and future strategies to identify and assess military beneficiaries were outlined. Military allergists had a formal discussion at the Tri-service Military Allergy Immunology Assembly regarding the state of penicillin allergy testing in military allergy clinics. RESULTS: A PubMed search yielded 5,775 results for "penicillin allergy" and 484 results for "penicillin allergy testing." There were two formalized penicillin testing programs in the military treatment facilities. In 2017, the military trained nearly 165,000 new recruits. If 5-10% reported a penicillin allergy and 90% were de-labeled, that would yield a $15-30 million cost savings annually. Further, de-labeling of the 9.4 million active duty, beneficiaries and retirees with a 90% success rate could result in even greater savings for the military health care system. CONCLUSION: A penicillin allergy label is a risk to military readiness secondary to associated increases in the length of hospitalizations and emergency department and medical visits. Penicillin de-labeling is a simple intervention that can improve readiness, significantly decrease health care costs and prevent antibiotic resistance, as well as antibiotic-associated adverse events. The military allergist should be "front and center" providing expertise guidance and leadership for clinic and hospital-based penicillin de-labeling efforts which are nested within the antibiotic stewardship programs.

Reliability and validity of the Thai Drug Hypersensitivity Quality of Life Questionnaire: a multi-center study.

OBJECTIVE: To adapted the Drug Hypersensitivity Quality of Life (DrHy-Q) Questionnaire from Italian into Thai and assessed its validity and reliability. DESIGN: Prospectively recruited during January 2012-May 2017. SETTING: Multicenter; six Thai tertiary university hospitals. STUDY PARTICIPANTS: Total of 306 patients with physician-diagnosed drug hypersensitivity. INTERVENTIONS: Internal consistency and test-retest reliability were evaluated among 68 participants using Cronbach's ɑ and intra-class correlation coefficient (ICC). The validity of Thai DrHy-Q was assessed among 306 participants who completed World Health Organization Quality of Life-BREF (WHOQOL-BREF-THAI). Construct and divergent validities were assessed for Thai DrHy-Q. Known-groups validity assessing discriminating ability was conducted in Thai DrHy-Q and WHOQOL-BREF-THAI. MAIN OUTCOME MEASURES: Validity; reliability; single vs. multiple drug allergy; non-severe cutaneous adverse reactions (SCAR) vs. SCAR. RESULTS: Thai DrHy-Q showed good reliability (Cronbach's ɑ = 0.94 and ICC = 0.8). Unidimensional factor structure was established by confirmatory factor analysis (CFI&TLI = 0.999, RMSEA = 0.02). Divergent validity was confirmed by weak correlation between Thai DrHy-Q and WHOQOL-BREF-THAI domains (Pearson's r = -0.41 to -0.19). Known-groups validity of Thai DrHy-Q was confirmed with significant difference between patients with and without life-threatening SCAR (P = 0.02) and patients with multiple implicated drug classes vs. those with one class (P < 0.01); while WHOQOL-BREF-THAI could differentiate presence of life-threatening SCAR (P < 0.01) but not multiple-drug allergy. CONCLUSIONS: Thai DrHy-Q was reliable and valid in evaluating quality of life among patients with drug hypersensitivity. Thai DrHy-Q was able to discriminate serious drug allergy phenotypes from non-serious manifestations in clinical practice and capture more specific drug-hypersensitivity aspects than WHOQOL-BREF-THAI.

Assessment of validity and reliability of Drug Hypersensitivity Quality of Life Questionnaire: The Dutch experience.

SUMMARY: Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q) is the first questionnaire that captures health related quality of life impact in patients with drug hypersensitivity. The aim of this study was to translate and validate the original Italian 15-item DrHy-Q for use among Dutch-speaking residents. We also compared the DrHy-Q scores obtained across countries. In a prospective cohort study, the Dutch DrHy-Q was completed by 124 patients (65.3% female, age 56.8 ± 14.0) with a confirmed drug hypersensitivity. Median DrHy-Q score was 12 [0-88]. Validity and reliability of the DrHy-Q was confirmed through, 1, confirmatory factor analysis; 2, concurrent validity with a generic health related quality of life questionnaire (RAND-36); 3, internal consistency; and 4, test-retest reliability. A country specific difference in scores was observed.

De-labelling self-reported penicillin allergy within the emergency department through the use of skin tests and oral drug provocation testing.

OBJECTIVE: Self-reported penicillin allergy is common among patients attending the ED, but is a poor predictor of true immunoglobulin E-mediated hypersensitivity to penicillin. We hypothesise that with a combination of skin testing and drug provocation testing, selected patients can be safely de-labelled of their allergy. METHODS: This prospective study enrolled a sample of patients presenting to an urban academic ED between 2011 and 2016 with a self-reported allergy to penicillin. Standardised skin prick and intradermal testing with amoxicillin and both major and minor determinants of penicillin was performed in the department. If negative, testing was followed by a graded oral challenge of amoxicillin over 9 days. The primary end point was the allergy status of participants at the end of the study. RESULTS: A total of 100 patients (mean age 42; standard deviation 14 years; 54% women) completed the testing. Of these, 81% (95% confidence interval 71.9-88.2) showed no hypersensitivity to penicillin and were labelled non-allergic. The majority (16/19) of allergies were confirmed by skin testing, with three suspected allergies detected by the oral challenge. Women were more likely than men to have a true penicillin allergy, with odds ratio of 4.0 (95% confidence interval 1.23-13.2). There were no serious adverse events. CONCLUSION: Selected patients in the ED who self-report an allergy to penicillin can be safely tested there for penicillin allergy, using skin tests and oral drug provocation testing. This testing allows a significant de-labelling of penicillin allergy, with the majority of these patients able to tolerate penicillin without incident.

Harnessing the placebo effect: Exploring the influence of physician characteristics on placebo response.

OBJECTIVE: Research on placebo/nocebo effects suggests that expectations can influence treatment outcomes, but placebo/nocebo effects are not always evident. This research demonstrates that a provider's social behavior moderates the effect of expectations on physiological outcomes. METHODS: After inducing an allergic reaction in participants through a histamine skin prick test, a health care provider administered a cream with no active ingredients and set either positive expectations (cream will reduce reaction) or negative expectations (cream will increase reaction). The provider demonstrated either high or low warmth, or either high or low competence. RESULTS: The impact of expectations on allergic response was enhanced when the provider acted both warmer and more competent and negated when the provider acted colder and less competent. CONCLUSION: This study suggests that placebo effects should be construed not as a nuisance variable with mysterious impact but instead as a psychological phenomenon that can be understood and harnessed to improve treatment outcomes. (PsycINFO Database Record

Cross sectional questionnaire-based internet study: Self-perception and clinical course of drug allergy in Greece.

BACKGROUND: Data on self perception of drug allergy in the general population are lacking. Epidemiological studies focus either on specific populations or document adverse drug reactions in general. Our objective was to document self-reported drug allergy in Greece, through a simple, informative internet-based questionnaire. METHODS: A questionnaire on drug allergy was accessible online for a 3-month period. Participants voluntarily answered 28 questions referring to: suspected drug, clinical manifestations, concomitant factors, received treatment, reaction's re-occurrence. RESULTS: A total of 2528 questionnaires were included in study analysis. Beta-lactams and non-steroidal anti-inflammatory drugs were the most prevalent culprit agents (53% and 27.5% respectively) while half of the participants acknowledged skin manifestations as the most common symptoms. One out of three reported subsequent exposure to the drug presumed to be responsible for the reaction and 74.5% of those stated a new reaction upon re-exposure. Only 26.7% underwent allergological evaluation. Reactions manifested with respiratory or cardiovascular symptoms, parenteral administration of the culprit drug and personal history of allergy to agents of >1 different pharmacological categories were associated with increased risk of hospitalization. CONCLUSIONS: Allergic reactions to drugs are adverse events difficult to define and diagnose. A remarkable proportion of presumed as hypersensitivity reactions are not referred to allergists; therefore these patients may be either re-exposed to potentially noxious drugs, or needlessly avoid whole classes of drugs as b-lactams for more costly or less appropriate treatments. Internet-based questionnaires may contribute to awareness programs concerning drug allergy and help improve proper referral.

Turkish version of the Drug Hypersensitivity Quality of Life Questionnaire: assessment of reliability and validity.

PURPOSE: The first disease-specific quality-of-life questionnaire in patients with drug hypersensitivity, Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q), was developed and validated recently. The aim of this study was to assess validity, reliability and responsiveness to interventions of the Turkish version of the DrHy-Q. METHODS: The Turkish version of the DrHy-Q was administered to prospectively enrolled 736 patients with drug hypersensitivity from ten allergy units. To assess validity, all patients completed the validated Turkish version of Psychological General Well-Being Index (PGWBI). For test-retest reliability, 182 patients completed the DrHy-Q 1 week after the first questionnaire administration without any intervention. Responsiveness was assessed on 97 patients who had a DrHy-Q recorded at a follow-up visit after the intervention. RESULTS: The internal consistency and test-retest reliability of the scale were adequate (Cronbach's alpha = 0.934, intra-class correlation coefficient = 0.783). The DrHy-Q scores showed weak negative correlations with the PGWBI total and domain scores (r = - 0.378 to -0.254, p < 0.001). DrHy-Q was able to discriminate the patients with one drug hypersensitivity reaction from the patients with two and above two reactions (p = 0.012 and p < 0.001, respectively), and the patients who experienced a respiratory reaction from the patients who did not (p = 0.018). However, it did not discriminate the patients with comorbid disease including psychiatric comorbidity (p > 0.05). The baseline DrHy-Q scores were significantly higher than the post-intervention scores (p = 0.008). CONCLUSION: The Turkish version of DrHy-Q is reliable and valid for evaluating quality of life in patients with drug hypersensitivity, and it appeared responsive to interventions.

Psychometric validation of the Spanish version of the DHRQoL questionnaire

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Evaluation of anxiety levels and factors associated with positive test results in patients with drug hypersensitivity.

BACKGROUND: High anxiety has been reported in patients with drug hypersensitivity reaction (DHR); however, its relationship with the test results was not studied previously. OBJECTIVE: We aimed to investigate the association of patient anxiety with the results of drug tests together with the other contributing factors. METHODS: Sixty-seven patients were included in the study between November 2012 and April 2013, in whom drug tests were performed after clinical evaluation and application of the Penn State Worry Questionnaire (PSWQ). RESULTS: The mean ± standard deviation (SD) age was 43.5 ± 12.9 years, and 73.1% of the patients were females. The patient group had significantly higher mean ± SD PSWQ score than 35 control subjects without histories of DHRs and major psychiatric disorders (47.95 ± 14.64 versus 40.22 ± 11.86, p = 0.008). However, the mean ± SD. PSWQ score of the patients with positive drug test results was not significantly different from the patients with negative drug test results (46.06 ± 13.41 versus 50.47 ± 18.02, p = 0.32). Panic attack symptoms were more common in the reactions with positive test results than in the reactions with negative test results (74.0% versus 48.9%, p = 0.01). However, presence of panic attack symptoms [odds ratio (OR): 1.25, 95% confidence interval (CI): 0.44-3.54; p = 0.67] was not found independently associated with positive test results in the multiple logistic regression model. CONCLUSION: Patients with DHR have high levels of anxiety; however, this is not related to the results of drug tests. Because panic reaction symptoms may accompany the objective symptoms of DHR, a complete clinical work-up is required before deciding whether the reaction is related to panic or a "true DHR."

High perceived sensitivity to medicines is associated with higher medical care utilisation, increased symptom reporting and greater information-seeking about medication.

PURPOSE: The belief that one is especially sensitive to the actions and side effects of medicines can influence treatment adherence and side-effect reporting. In this study, we investigated the prevalence of perceived medication sensitivity in the general population and its relationship to symptom complaints, information seeking about medications, use of medical care and demographic factors. METHODS: A nationally representative sample of 1000 New Zealand residents completed the Perceived Sensitivity to Medicines scale and symptoms experienced during the previous 7 days. Demographic data and medical visits, medication use and information seeking about medicines were also collected. RESULTS: Over 20% of the general population reported being very sensitive to the effects of medication (20.2%) and that small amounts of medicines can upset their body (25.3%). Participants who reported high levels of perceived sensitivity to medicines reported significantly more symptoms (M = 9.54, SE = 0.47) than people with low (M = 5.04, SE = 0.49) or moderate (M = 5.91, SE = 0.24) levels, ps < .001. This relationship was strongest in participants who were currently taking prescription medication. Those with high perceived sensitivity also reported being more likely to seek information about medicines, and had significantly more general practitioner visits. CONCLUSIONS: Perceived sensitivity to medicines is common in the population and associated with important clinical variables including information seeking, GP visits and symptom reporting. Identifying patients with higher perceived sensitivity to medicines may improve patient care by providing the basis for targeted and personalised interventions to reduce side effects and improve adherence to medications.

Quality-of-life issues in survivors to anaphylactic reactions to drugs.

The aim of this cross-sectional observational study was to explore quality of life and well-being in patients with drug-induced anaphylaxis. Two validated tools were used: the Drug Hypersensitivity Quality-of-Life Questionnaire (DrHy-Q) and the Psychological General Well-Being Index (PGWBI). Sixty-five patients (13 males) underwent data analysis. The mean DrHy-Q score was 62.82 ± 12.1. Mean PGWBI score was 64.03 ± 17.66. DrHy-Q score was significantly correlated with PGWBI total score (r = -0.314; P = 0.011) and with the following domains: Anxiety (r = -0.260; P = 0.036), Depressed mood (r = -0.406; P = 0.001), Positive well-being (r = -0.251; P = 0.004), and General Health (r = -0.352; P = 0.004). Compared with the Italian reference population, patients had a significantly reduced PGWBI total and domain score. Our results highlight for the first time how impaired HRQoL and distress commonly feature in survivors to anaphylactic reactions to drug.

SELF-REPORTED DRUG ALLERGIES IN SURGICAL POPULATION IN SERBIA.

History of drug allergy is of major concern during perioperative period. Medical records usually lack documents confirming the stated allergy. This study aimed to investigate the prevalence of self-reported drug allergies and their characteristics in adult Serbian surgical population, and to analyze their influence on drug prescription during perioperative period. The study enrolled patients scheduled for general surgery during a one-year period at a tertiary care hospital. They were questioned using a structured questionnaire about the existence of drug allergy and its nature. Medical records were examined after discharge to assess medical prescription during hospitalization. Of 1126 patients evaluated during the study period, 434 (38.5%) reported a total of 635 drug reactions. The most common allergy claim was to antibiotics (68%), nonsteroidal antiinflammatory drugs (16.4%) and iodine (3.9%). Women, urban residents and herbal drug consumers were more likely to state an allergy. The majority of reported reactions were cutaneous (72%) and respiratory (34%), while anaphylaxis was reported by 3.2% of patients. Only 38 (8.7%) patients had previously undergone any allergology testing. Retrospective chart review revealed that 26 (6%) patients were administered the drug to which they had reported allergic reaction in the past, with no adverse effects. Drug allergies are frequently self-reported in surgical population in Serbia, which is in contrast to a very low rate of explored and documented allergies. In order not to deny an effective treatment or postpone a surgery, health care practitioners should pay more attention to an accurate classification of adverse drug reactions.

An unanticipated allergic reaction to a hypnotic suggestion for anesthesia: a brief communication and commentary.

During a demonstration of hypnotically induced anesthesia and following a suggestion for a Novocain-like numbness, a totally unanticipated and dramatic swelling of 1 cheek appeared. The participant had forgotten to inform the psychologist that she had experienced the identical reaction to Novocain when she received an injection a few weeks earlier. The swelling was quickly removed by a countersuggestion based upon a simulated injection of the antidote previously administered by the dentist. This case report is relevant to current research and theorizing on the interaction of hypnosis with the immune system. The fact that it was retrospectively recognized as a single-case time-series B-A-B design significantly enhances its scientific value beyond that afforded by the traditional case report.

Adverse reactions during drug challenges: a single US institution's experience.

BACKGROUND: Drug challenge is a useful tool when diagnostic testing lacks predictive value for a questionable history of drug allergy. Placebo-controlled drug challenge studies demonstrate that a significant number of patients report purely subjective symptoms to placebo. OBJECTIVE: To evaluate the safety and rate of adverse effects when performing drug challenges and to identify predictive factors for occurrences of subjective symptoms during drug challenges. METHODS: We performed a 6-year, retrospective medical record review of patients who underwent drug challenges by members of the Allergy and Immunology Division after consultation deemed drug challenges to be appropriate. Statistical analysis was performed to compare the proportion of patients with subjective symptoms based on certain factors, including sex, age, number of listed drug allergies, interval from historical drug reaction to the drug challenge, and types of historical reaction. RESULTS: A total of 114 patients underwent 123 drug challenges. Only 1 patient was deemed to have a true positive drug challenge result. Twenty patients reported subjective symptoms during graded challenge, all of which were not deemed a positive challenge. There was a significantly higher proportion of patients who reported subjective symptoms in females, those with a higher number of listed drug allergies, and those whose historical reactions were primarily subjective in nature. CONCLUSION: Drug challenges are safe procedures in appropriately selected patients. A number of patients report subjective symptoms during drug challenges. Identifying patients at high risk for subjective symptoms may assist in determining whether placebo-controlled drug challenges should be performed.