OBJECTIVE: We conducted a phase 1/2 clinical study to examine the safety and diagnostic accuracy (sensitivity and specificity) of nonammoniated latex, ammoniated latex, and rubber glove extracts as skin test extracts to identify the most efficacious source material for future skin test reagent development.

METHODS: Twenty-four adults not allergic to latex, 19 adults with hand dermatitis or pruritus, and 59 adults with a latex allergy were identified by clinical history. All provided blood and then received puncture skin tests and intradermal skin tests with nonammoniated latex, ammoniated latex, and rubber glove extracts from Malaysian H. brasiliensis latex by use of sequential titration. A glove provocation test and IgE anti-latex RAST were used to clarify positive history-negative skin test response and negative history-positive skin test response mismatches.

RESULTS: All three extracts were biologically safe and sterile. After normalization to 1 mg/ml of total protein, all three extracts produced equivalent diagnostic sensitivity and specificity in puncture skin tests and intradermal skin tests at various extract concentrations. Optimal diagnostic accuracy was safely achieved at 100 micrograms/ml for intradermal skin tests (e.g., nonammoniated latex: puncture skin test sensitivity 96%, specificity 100%; intradermal skin test sensitivity 93%, specificity 96%). The presence of IgE antibody in skin was highly correlated with IgE anti-latex in serum (nonammoniated latex: r = 0.98, p < 0.001; ammoniated latex: r = 0.94, p < 0.001; rubber glove extract: r = 0.96, p < 0.001). All five available subjects with a positive history, negative skin test response, and absence of IgE antibody in serum had a negative glove provocation test response, indicating no clinical evidence of latex allergy. No systemic or large local allergic reactions were observed with puncture skin tests or intradermal skin tests.

METHODS: The SAQ was translated from English to Turkish using the back-translation method. It contains 19 questions scored from 1 to either 5 or 6 in 5 domains (physical limitation, angina stability, angina frequency, disease perception, and treatment satisfaction). Cronbach's alpha coefficient was used to evaluate internal consistency. Spearman's rank correlation coefficient was calculated to assess the construct validity. Convergent validity was examined using correlations between the SAQ and the MacNew Heart Disease Health-related Quality of Life Questionnaire (MacNew) and the Nottingham Health Profile. Divergent validity was evaluated using correlations between the SAQ and age, body mass index (BMI), gender, and the marital status of patients. A value of p<0.05 was considered statistically significant.

RESULTS: Sixty-seven patients were enrolled in the study. The mean age of the study patients was 58.7 years (SD: 10.2). Cronbach's alpha scores of the SAQ, ranging in value from 0.715 to 0.910, demonstrated that this scale is reliable. All of the SAQ scales had a significant correlation with all of the MacNew scales, which indicated that the scale has convergent validity. Insignificant correlations with age, BMI, gender, and marital status illustrated the good divergent validity of the scale.

METHODS: A questionnaire development and validation study was conducted. The resilience domains and items were identified and generated through a literature review. The content validation was carried out by content experts and the content validity index (CVI) was calculated. The face validation was performed by medical officers and the face validity index (FVI) was calculated. The final MeRS was administered to 167 medical officers, exploratory factor analysis (EFA) and reliability analysis were performed to assess MeRS's factorial structure and internal consistency.

RESULTS: Four domains with 89 items of medical professionals' resilience were developed. Following that, the content and face validation was conducted, and a total of 41-items remained for construct validation. EFA extracted four factors, namely growth, control, involvement, and resourceful, with a total of 37 items. The items' CVI and FVI values were more than 0.80. The final MeRS's items had factor loading values ranged from 0.41 to 0.76, and the Cronbach's alpha values of the resilience domains ranged from 0.72 to 0.89.