José M. Quintana

El Cuestionario de Salud SF-36 español: una década de experiencia y nuevos desarrollos

Objetivo: El Cuestionario SF-36 es uno de los instrumentos de Calidad de Vida Relacionada con la Salud (CVRS) mas utilizados y evaluados. Tras una decada de uso este articulo revisa criticamente el contenido, propiedades metricas y nuevos desarrollos de la version espanola. Metodos: Revision de los articulos indizados en Medline (PubMed) y en las bases de datos IBECS e IME que han utilizado la version espanola del cuestionario. Se seleccionaron los articulos con informacion sobre modelo de medida, fiabilidad, validez y sensibilidad al cambio del instrumento. Resultados: Se encontraron 79 articulos, 17 de los cuales describian caracteristicas metricas del cuestionario. En el 96% las escalas superaron el estandar propuesto de fiabilidad (α de Cronbach) de 0,7. Las estimaciones agrupadas obtenidas por metaanalisis fueron superiores a 0,7 en todos los casos. El SF-36 mostro buena discriminacion entre grupos de gravedad, correlacion moderada con indicadores clinicos y alta con otros instrumentos de CVRS. El SF-36 predijo mortalidad y detecto mejoria tras la angioplastia coronaria, la cirugia de hipertrofia prostatica benigna o la ventilacion domiciliaria no invasiva. Los nuevos desarrollos descritos (puntuaciones basadas en normas, la version 2, el SF-12 y el SF-8) mejoraron sus propiedades metricas y su interpretacion. Conclusiones: El SF-36, conjuntamente con las nuevas versiones desarrolladas, es un instrumento muy adecuado para su uso en investigacion y en la practica clinica.

Responsiveness and clinically important differences for the WOMAC and SF-36 after hip joint replacement

OBJECTIVES To study responsiveness and establish the minimal clinically important differences (MCID) and minimal detectable change (MDC) in patients undergoing total hip replacement (THR) using the Short Form 36 (SF-36) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). METHODS We conducted a prospective observational study in three public hospitals of all consecutive patients with a diagnosis of hip osteoarthritis (OA) on waiting lists to undergo THR. Patients completed the SF-36 and the WOMAC (subscales transformed to 0 to 100), which measured the health-related quality of life (HRQoL), before intervention and 6 months and 2 years later, and additional transitional questions, which measured the changes in the joint 6 months postoperatively. RESULTS Improvements at 6 months after a THR were between 37 (stiffness) and 39 points (pain), depending on the WOMAC domain. The SF-36 domains also showed improvements: physical function (31.91), physical role (33.71), and bodily pain (29.77). From 6 months to 2 years, improvements ranged from 2 to 5 points, except for role physical (13.25). A ceiling effect was detected on some WOMAC domains as well as a floor effect on the SF-36. The MCID ranged from 25.91 (stiffness) to 29.26 (pain) on the WOMAC and from 10.78 (physical role) to 20.40 (physical function) on the SF-36. The MDC ranged from 21.38 (pain) to 27.98 (stiffness) on the WOMAC and from 18.99 (physical function) to 42.05 (social function) on the SF-36. CONCLUSIONS These values indicate expected gains after THR. However, the MCID and MDC values must be viewed cautiously due to the uncertainty of these estimators and should not be considered as absolute thresholds.

Validation of a predictive rule for the management of community-acquired pneumonia

The CURB-65 score (Confusion, Urea >7 mmol·L−1, Respiratory rate ≥30·min−1, low Blood pressure, and age ≥65 yrs) has been proposed as a tool for augmenting clinical judgement for stratifying patients with community-acquired pneumonia (CAP) into different management groups. The six-point CURB-65 score was retrospectively applied in a prospective, consecutive cohort of adult patients with a diagnosis of CAP seen in the emergency department of a 400-bed teaching hospital from March 1, 2000 to February 29, 2004. A total of 1,100 inpatients and 676 outpatients were included. The 30-day mortality rate in the entire cohort increased directly with increasing CURB-65 score: 0, 1.1, 7.6, 21, 41.9 and 60% for CURB-65 scores of 0, 1, 2, 3, 4, and 5, respectively. The score was also significantly associated with the need for mechanical ventilation and rate of hospital admission in the entire cohort, and with duration of hospital stay among inpatients. The CURB-65 score (Confusion, Urea >7 mmol·L−1, Respiratory rate ≥30·min−1, low Blood pressure, and age ≥65 yrs), and a simpler CRB-65 score that omits the blood urea measurement, helps classify patients with community-acquired pneumonia into different groups according to the mortality risk and significantly correlates with community-acquired pneumonia management key points. The new score can also be used as a severity adjustment measure.

Predictors of patient satisfaction with hospital health care

BackgroundWe used a validated inpatient satisfaction questionnaire to evaluate the health care received by patients admitted to several hospitals. This questionnaire was factored into distinct domains, creating a score for each to assist in the analysis.We evaluated possible predictors of patient satisfaction in relation to socio-demographic variables, history of admission, and survey logistics.MethodsCross-sectional study of patients discharged from four acute care general hospitals. Random sample of 650 discharged patients from the medical and surgical wards of each hospital during February and March 2002. A total of 1,910 patients responded to the questionnaire (73.5%). Patient satisfaction was measured by a validated questionnaire with six domains: information, human care, comfort, visiting, intimacy, and cleanliness. Each domain was scored from 0 to 100, with higher scores indicating higher levels of patient satisfaction.ResultsIn the univariate analysis, age was related to all domains except visiting; gender to comfort, visiting, and intimacy; level of education to comfort and cleanliness; marital status to information, human care, intimacy, and cleanliness; length of hospital stay to visiting and cleanliness, and previous admissions to human care, comfort, and cleanliness. The timing of the response to the mailing and who completed the questionnaire were related to all variables except visiting and cleanliness. Multivariate analysis confirmed in most cases the previous findings and added additional correlations for level of education (visiting and intimacy) and marital status (comfort and visiting).ConclusionThese results confirm the varying importance of some socio-demographic variables and length of stay, previous admission, the timing of response to the questionnaire, and who completed the questionnaire on some aspects of patient satisfaction after hospitalization. All these variables should be considered when evaluating patient satisfaction.

Improvement of process-of-care and outcomes after implementing a guideline for the management of community-acquired pneumonia: A controlled before-and-after design study

BACKGROUND Studies investigating the impact of guideline implementation for inpatient management of community-acquired pneumonia (CAP) usually have methodological limitations. We present a controlled study that compared interventions before and after the implementation of a practice guideline. METHODS Clinical and demographic characteristics, as well as process-of-care and outcome indicators, were recorded for all patients with CAP who were admitted to Galdakao Hospital (Galdakao, Spain) in the 19-month period after the implementation, on 1 March 2000, of a guideline for the treatment of CAP. These data were also recorded for all patients with CAP who were admitted to this hospital during the year before the guideline was implemented, as well as for randomly selected inpatients with CAP at 4 other hospitals during both periods (i.e., before and after guideline implementation) who were chosen as an external comparison group. Multivariate linear and logistic regression models were employed for adjustment. RESULTS Guideline implementation resulted in shorter durations of antibiotic treatment (P<.001) and intravenous treatment (P<.001), better coverage of atypical pathogens (P<.001), and improved appropriateness of antibiotic treatment (P<.001), compared with the period before the guideline was implemented. The adjusted analyses revealed decreases in 30-day mortality (odds ratio [OR], 2.14; 95% confidence interval [CI], 1.23-3.72) and in-hospital mortality (OR, 2.46; 95% CI, 1.37-4.41) and a 1.8-day reduction in the duration of hospital stay. In the control hospitals, there were small but statistically insignificant changes in these indicators for admitted patients. CONCLUSIONS This study, which was performed with an adequate, controlled before-and-after intervention design, demonstrated significant improvements in both process-of-care and outcome indicators after implementation of a guideline for treating CAP.

The Spanish version of the Short Form 36 Health Survey: a decade of experience and new developments

OBJECTIVE The Short Form-36 Health Survey (SF-36) is one of the most widely used and evaluated generic health-related quality of life (HRQL) questionnaires. After almost a decade of use in Spain, the present article critically reviews the content and metric properties of the Spanish version, as well as its new developments. METHODS A review of indexed articles that used the Spanish version of the SF-36 was performed in Medline (PubMed), the Spanish bibliographic databases IBECS and IME. Articles that provided information on the measurement model, reliability, validity, and responsiveness to change of the instrument were selected. RESULTS Seventy-nine articles were found, of which 17 evaluated the metric characteristics of the questionnaire. The reliability of the SF-36 scales was higher than the suggested standard (Cronbachs alpha) of 0.7 in 96% of the evaluations. Grouped evaluations obtained by meta-analysis were higher than 0.7 in all cases. The SF-36 showed good discrimination among severity groups, moderate correlations with clinical indicators, and high correlations with other HRQL instruments. Moreover, questionnaire scores predicted mortality and were able to detect improvement due to therapeutic interventions such as coronary angioplasty, benign prostatic hyperplasia surgery, and non-invasive positive pressure home ventilation. The new developments (norm-based scoring, version 2, the SF-12 and SF-8) improved both the metric properties and interpretation of the questionnaire. CONCLUSIONS The Spanish version of the SF-36 and its recently developed versions is a suitable instrument for use in medical research, as well as in clinical practice.

Influenza Vaccine Effectiveness in Preventing Outpatient, Inpatient, and Severe Cases of Laboratory-Confirmed Influenza

BACKGROUND In most seasons, the influenza vaccine is effective in preventing influenza, but it is not clear whether it is equally effective in preventing mild and severe cases. We designed a case-control study to compare the effectiveness of the influenza vaccine in preventing outpatient, inpatient, and severe or fatal cases of laboratory-confirmed influenza. METHODS Hospitalized patients (n = 691) with laboratory-confirmed influenza in the 2010-2011 season recruited in 29 Spanish hospitals were individually matched by age, admission/visit date, and province with an outpatient with laboratory-confirmed influenza and an outpatient control. Severe cases were considered those patients admitted to intensive care units or who died in the hospital (n = 177). We compared the influenza vaccine status of controls and outpatient cases, inpatient cases, and severe cases using conditional logistic regression adjusted for potential confounding factors. Severe and nonsevere inpatient influenza cases were compared using unconditional logistic regression. Vaccine effectiveness was (1 - odds ratio) × 100. RESULTS Vaccine effectiveness was 75% (adjusted odds ratio [AOR], 0.25; 95% confidence interval [CI], .16-.39) in preventing influenza outpatient cases, 60% (AOR, 0.40; 95% CI, .25-.63) in preventing influenza-associated hospitalizations, and 89% (AOR, 0.11; 95% CI, .04-.37) in preventing severe cases. In inpatients, influenza vaccination was associated with a lower risk of severe influenza (AOR, 0.42; 95% CI, .22-.80). CONCLUSIONS Influenza vaccination prevented influenza cases and hospitalizations and was associated with a better prognosis in inpatients with influenza. The combined effect of these 2 mechanisms would explain the high effectiveness of the vaccine in preventing severe cases due to influenza.

DEVELOPMENT OF EXPLICIT CRITERIA FOR TOTAL KNEE REPLACEMENT

OBJECTIVES To develop and test an appropriateness of indications tool for total knee replacement (TKR) in patients with osteoarthritis. METHODS Criteria were developed using a modified Delphi panel judgment. Another panel rated the same indications, and the results were compared with the main panel. Test-retest of the main panel was performed. Regression models were used to assess the contribution of each algorithm variable. A classification tree was developed. RESULTS The procedure was considered appropriate in 167 (26.8%) scenarios, and there was agreement on 112 (67.1%) of them. When the rates of the main panel were compared with those of a second panel, the result was a kappa statistic of 0.75. The test-retest kappa for the main panel was 0.78. Neither in the first case nor in the second was there an instance in which a scenario classified as appropriate shifted to inappropriate or vice versa. The regression models showed that symptomatology and radiology were the variables that explained most of the variability of appropriateness as determined by panelists. In the classification tree performed, the probability of misclassification was 3.8% with 150 scenarios, of the 156 analyzed and classified correctly. CONCLUSIONS The previous parameters tested showed acceptable results for an evaluation tool. These results support the use of this algorithm as an aid in formulating clinical practice guidelines and to promote the appropriateness of TKR.

Patient acceptable symptom state and OMERACT–OARSI set of responder criteria in joint replacement. Identification of cut-off values

OBJECTIVE To identify new cut-off values beyond which patients can be considered as satisfied or as responders through patient acceptable symptom state (PASS) and OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) set of responder criteria in total joint replacement. METHODS Secondary analysis of a 1-year prospective multicenter study of 861 patients, 510 with total knee replacement (TKR) and 351 with total hip prosthesis (THR). Pain and function data were collected by the reverse scoring option of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). PASS values were identified with the 25th centile estimation using an anchoring question about satisfaction with actual symptoms. OMERACT-OARSI set of responder criteria was based on a combination of absolute and relative change of pain, function and global patients assessment. Receiver operating characteristic (ROC) analysis was used as a complementary approach. RESULTS The values for PASS were about 80 and 69 for pain and function in THR, while these values were 80 and 68 when using OMERACT-OARSI criteria. Regarding TKR, PASS values were about 75 and 67 in pain and function with both criteria. ROC values were slightly lower in all cases. PASS and OMERACT-OARSI values varied moderately across tertiles of baseline severity. CONCLUSION With the provided data we can establish when a patient can be considered as satisfied/responder in joint replacement. The scores achieved at 1 year were very similar according to both criteria.

Evaluation of explicit criteria for total hip joint replacement

We tested an appropriateness of indications tool for total hip joint replacement in patients with osteoarthritis. Criteria were developed using a modified Delphi panel judgment process. Ratings were analyzed regarding level of agreement among panelists. Another panel rated the same indications; results were compared with the main panel. Test-retest of the main panel was performed. Regression models were used to assess the contribution of each algorithm variable. Appropriateness indication judgment was applied to 84 patients and compared to health-related quality-of-life improvement before and 3 months following intervention. Main panel ratings compared to those of a second panel resulted in a kappa statistic of 0.77. Test-retest kappa for the main panel was 0.81. Patients considered appropriate candidates for surgery, based on their composite indication scores, showed more improvement in health-related quality of life after 3 months than those considered inappropriately by composite indication scores. The previous parameters tested showed acceptable results for an evaluation tool. These results support the use of this indications algorithm as a screening tool for assessing the appropriateness of hip replacement surgery in osteoarthritis.