Cross-cultural adaptation of the FRAIL scale for critically ill patients in Spain.

AIM: To translate and culturally adapt the FRAIL scale into Spanish and perform a preliminary test of diagnostic accuracy in patients admitted to intensive care units. DESIGN: Cross-sectional diagnostic study. METHODS: Five intensive care units (ICU) in Spain were participated. Stage 1: Three native Spanish-speaking bilingual translators familiar with the field of critical care translated the scale from English into Spanish. Stage 2: Three native English-speaking bilingual translators familiar with critical care medicine. Stage 3: Authors of the original scale compared the English original and back-translated versions of the scale. Stage 4: Five nurses with more than 5 years of ICU experience and five critical care physicians assessed the comprehension and relevance of each of the items of the Spanish version in 30 patients of 3 different age ranges (<50, 50-65 and >65 years). RESULTS: The FRAIL scale was translated and adapted cross-culturally for patients admitted to intensive care units in Spain. The process consisted of four stages: translation, back translation, comparison and pilot test. There was good correspondence between the original scale and the Spanish version in 100% of the items. The participating patients assessed the relevance (content validity) and comprehensibility (face validity) of each of the items of the first Spanish version. The relevance of some of the items scored low when the scale was used in patients younger than 65 years. CONCLUSIONS: We have cross-culturally adapted the FRAIL scale, originally in English, to Spanish for its use in the critical care medical setting in Spanish-speaking countries. IMPLICATIONS FOR PROFESSIONALS: Physicians and nurses can apply the new scale to all patients admitted to the intensive care units. Nursing care can be adapted according to frailty, trying to reduce the side effects of admission to these units for the most fragile patients. REPORTING METHOD: The manuscript's authors have adhered to the EQUATOR guidelines, using the COSMIN reporting guideline for studies on the measurement properties of patient-reported outcome measures. PATIENT OR PUBLIC CONTRIBUTION: In a pilot clinical study, we applied the first version of the FRAIL-Spain scale to intensive care unit (ICU) patients. Five nurses with more than 5 years of ICU experience and five critical care physicians assessed the relevance (content validity) and comprehensibility (face validity) of the five items of the first Spanish version. Relevance was assessed using a 4-point Likert scale ranging from 1 (no relevance) to 4 (high relevance), and comprehensibility was assessed as poor, acceptable or good. Each health professional applied the scale to three patients (total number of patients = 30) of three different age ranges (<50, 50-65 and >65 years) and recorded the time of application of the scale to each patient. Although the frailty scales were initially created by geriatricians to be applied to the elders, there is little experience with their application in critically ill patients of any age. Therefore, more information is needed to determine the relevance of using this scale in critical care patients. In this pilot study, we considered that nurses and critical care physicians should evaluate frailty using this adapted scale in adult patients admitted to the Intensive Care Units.

Immunogenicity and reactogenicity of a combined adsorbed tetanus toxoid, low dose diphtheria toxoid, five component acellular pertussis and inactivated polio vaccine in six-year-old children.

BACKGROUND: The objective of this study was to assess the immunogenicity and reactogenicity of the combined adsorbed tetanus toxoid, low dose diphtheria toxoid, 5-component acellular pertussis and inactivated polio vaccine (TdcP-IPV) as compared with a pediatric dose diphtheria formulation, combined with adsorbed tetanus toxoid and 3-component acellular pertussis (DTacP), in 6-year-old children who were immunized with 4 doses of diphtheria-tetanus-whole cell cellular pertussis (DTwcP) plus oral polio vaccine (OPV) before 2 years of age, according to the local Spanish vaccination calendar. METHODS: One hundred ninety-four healthy 6-year-old children were randomized to receive 1 dose of TdcP-IPV or 1 dose of DTacP and OPV. RESULTS: One month postvaccination, antidiphtheria and antitetanus titers were > or =0.1 IU/mL in 100% of patients in both study groups. TdcP-IPV reached 100% seroprotection rates against polio types 1, 2 and 3. In OPV recipients, these rates were 100, 100 and 96.8%, respectively. Seropositivity rates for pertussis toxin, filamentous hemagglutinin, pertactin and fimbrial components of the TdcP-IPV vaccine were 97.9, 89.6, 90.6 and 100%. The incidence of local and systemic reactions was 50.5 and 39.2% in the TdcP-IPV group and 59.4 and 38.5% in the DTacP plus OPV group, and no serious adverse events were reported. CONCLUSIONS: TdcP-IPV vaccine was shown to be immunogenic and safe when given as a booster in children 6 years of age who were primed with 4 doses of DTwcP and OPV.