Amaia Bilbao

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.

Validation of the Spanish Version of the WOMAC Questionnaire for Patients with Hip or Knee Osteoarthritis

Abstract: The aim of this study was to validate a translated version of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire in Spanish patients with hip or knee osteoarthritis (OA). The WOMAC questionnaire and the SF-36 were administered to a sample of 269 patients on the waiting list for hip or knee replacement. We studied the convergent validity and the item-scale correlation using Pearson’s correlation coefficient and Spearman’s π. For the reliability study we used another sample of 58 patients who received the WOMAC twice within 15 days. The Pearson’s, Spearman’s π, and intraclass correlation coefficients were calculated. Internal consistency was measured by Cronbach’s α. The responsiveness study was carried out by resending the two questionnaires to all patients 6 months after surgical intervention; responsiveness was measured by means of the paired t-test, the effect size I and the standardised response mean. The Pearson’s coefficients for the convergent validity ranged from −0.52 to −0.63. The coefficients obtained for the item–scale correlation of the pain area were 0.74 or higher, 0.91 or higher for stiffness, and 0.61 or higher for function. When measuring the test–retest reliability, the coefficients ranged from 0.66 to 0.81. Internal consistency yielded a Cronbach’s α ranging from 0.81 to 0.93. The responsiveness showed an effect size I ranging from 1.5 to 2.2 in patients who underwent hip replacement; for those who underwent knee replacement the range was 1 to 1.8. The standardised response mean ranged from 1.3 to 1.9 for patients with hip OA; those with knee OA ranged from 0.8 to 1.5. The Spanish version of WOMAC is a valid, reliable and responsive instrument in patients with hip or knee OA.

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.

Prospective Comparison of Severity Scores for Predicting Clinically Relevant Outcomes for Patients Hospitalized With Community-Acquired Pneumonia

BACKGROUND The comparative accuracy and discriminatory power of three validated rules for predicting clinically relevant outcomes other than mortality in patients hospitalized with community-acquired pneumonia (CAP) are unknown. METHODS We prospectively compared the newly developed severe community-acquired pneumonia (SCAP) score, pneumonia severity index (PSI), and the British Thoracic Society confusion, urea > 7 mmol/L, respiratory rate > or = 30 breaths/min, BP < 90 mm Hg systolic or < 60 mm Hg diastolic, age > or = 65 years (CURB-65) rule in an internal validation cohort of 1,189 consecutive adult inpatients with CAP from one hospital and an external validation cohort of 671 consecutive adult inpatients from three other hospitals. Major adverse outcomes were admission to ICU, need for mechanical ventilation, progression to severe sepsis, or treatment failure. Mean hospital length of stay (LOS) was also evaluated. The rules were compared based on sensitivity, specificity, and area under the curve (AUC) of the receiver operating characteristic. RESULTS The rate of all adverse outcomes and hospital LOS increased directly with increasing SCAP, PSI, or CURB-65 scores (p < 0.001) in both cohorts. Patients classified as high risk by the SCAP score showed higher rates of adverse outcomes (ICU admission, 35.8%; mechanical ventilation, 16.4%; severe sepsis, 98.5%; treatment failure, 22.4%) than PSI and CURB-65 high-risk classes. The discriminatory power of SCAP, as measured by AUC, was 0.75 for ICU admission, 0.76 for mechanical ventilation, 0.79 for severe sepsis, and 0.61 for treatment failure in the external validation cohort. AUC differences with PSI or CURB-65 were found. CONCLUSIONS The SCAP score is as accurate or better than other current scoring systems in predicting adverse outcomes in patients hospitalized with CAP while helping classify patients into different categories of increasing risk for potentially closer monitoring.

Predictors of short-term rehospitalization following discharge of patients hospitalized with community-acquired pneumonia.

BACKGROUND Among patients hospitalized for community-acquired pneumonia (CAP), the risk factors for short-term hospital readmission after discharge are unknown. METHODS We conducted a prospective observational study of 1,117 patients who had been discharged alive after hospitalization for CAP. We collected variables associated with CAP severity at hospital admission, in-hospital clinical evolution, clinical instability factors on hospital discharge, therapy employed during hospitalization, and diagnostic bacteriology. We assessed hospital readmission within 30 days after discharge for the index hospitalization. Risk factors independently associated with 30-day hospital readmission were identified using Cox regression models. RESULTS Of the 81 patients (7.3%) who were readmitted to the hospital within 30 days, 29 (35.8%) were rehospitalized for pneumonia-related causes. Variables associated with pneumonia-related hospital readmission were treatment failure (hazard ratio [HR], 2.9; 95% CI, 1.2 to 6.8), and one or more instability factors on hospital discharge (HR, 2.8; 95% CI, 1.3 to 6.2). The predictive performance of these variables measured by the area under the curve (AUC) of the receiver operating characteristic was 0.65. Variables associated with pneumonia-unrelated hospital readmission were age >or= 65 years (HR, 4.5; 95% CI, 1.4 to 14.7), Charlson comorbidity index >or= 2 (HR, 1.9; 95% CI, 1.0 to 3.4), and decompensated comorbidities during in-hospital evolution (HR, 3.5; 95% CI, 2.0 to 6.3); the AUC for this model was 0.77. Patients with at least two risk factors were at significantly increased risk of 30-day hospital readmission (pneumonia-related CAP: HR, 9.0; 95% CI, 3.2 to 25.3; pneumonia-unrelated CAP: HR, 5.3; 95% CI, 1.6 to 18.1). CONCLUSIONS Among patients hospitalized for CAP, different risk factors are associated with hospital readmission related to pneumonia or to other causes. The identification of two different groups of patients who were at high risk of hospital readmission raises the possibility that different management strategies could decrease the rate of hospital readmissions.

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.

Duration of Antibiotic Treatment in Community-Acquired Pneumonia: A Multicenter Randomized Clinical Trial

IMPORTANCE The optimal duration of antibiotic treatment for community-acquired pneumonia (CAP) has not been well established. OBJECTIVE To validate Infectious Diseases Society of America/American Thoracic Society guidelines for duration of antibiotic treatment in hospitalized patients with CAP. DESIGN, SETTING, AND PARTICIPANTS This study was a multicenter, noninferiority randomized clinical trial performed at 4 teaching hospitals in Spain from January 1, 2012, through August 31, 2013. A total of 312 hospitalized patients diagnosed as having CAP were studied. Data analysis was performed from January 1, 2014, through February 28, 2015. INTERVENTIONS Patients were randomized at day 5 to an intervention or control group. Those in the intervention group were treated with antibiotics for a minimum of 5 days, and the antibiotic treatment was stopped at this point if their body temperature was 37.8°C or less for 48 hours and they had no more than 1 CAP-associated sign of clinical instability. Duration of antibiotic treatment in the control group was determined by physicians. MAIN OUTCOMES AND MEASURES Clinical success rate at days 10 and 30 since admission and CAP-related symptoms at days 5 and 10 measured with the 18-item CAP symptom questionnaire score range, 0-90; higher scores indicate more severe symptoms. RESULTS Of the 312 patients included, 150 and 162 were randomized to the control and intervention groups, respectively. The mean (SD) age of the patients was 66.2 (17.9) years and 64.7 (18.7) years in the control and intervention groups, respectively. There were 95 men (63.3%) and 55 women (36.7%) in the control group and 101 men (62.3%) and 61 women (37.7%) in the intervention group. In the intent-to-treat analysis, clinical success was 48.6% (71 of 150) in the control group and 56.3% (90 of 162) in the intervention group at day 10 (P = .18) and 88.6% (132 of 150) in the control group and 91.9% (147 of 162) in the intervention group at day 30 (P = .33). The mean (SD) CAP symptom questionnaire scores were 24.7 (11.4) vs 27.2 (12.5) at day 5 (P = .10) and 18.6 (9.0) vs 17.9 (7.6) at day 10 (P = .69). In the per-protocol analysis, clinical success was 50.4% (67 of 137) in the control group and 59.7% (86 of 146) in the intervention group at day 10 (P = .12) and 92.7% (126 of 137) in the control group and 94.4% (136 of 146) in the intervention group at day 30 (P = .54). The mean (SD) CAP symptom questionnaire scores were 24.3 (11.4) vs 26.6 (12.1) at day 5 (P = .16) and 18.1 (8.5) vs 17.6 (7.4) at day 10 (P = .81). CONCLUSIONS AND RELEVANCE The Infectious Diseases Society of America/American Thoracic Society recommendations for duration of antibiotic treatment based on clinical stability criteria can be safely implemented in hospitalized patients with CAP. TRIAL REGISTRATION clinicaltrialsregister.eu Identifier: 2011-001067-51.

Responsiveness and Clinically Important Differences for the VF-14 Index, SF-36, and Visual Acuity in Patients Undergoing Cataract Surgery

OBJECTIVE To assess visual acuity (VA) and 2 questionnaires of health-related quality of life--the Visual Function 14 (VF-14) index and the Medical Outcomes Study Short Form 36 Health Survey (SF-36)--as instruments for capturing clinically important changes after cataract surgery. DESIGN Prospective, observational study. PARTICIPANTS Four thousand three hundred fifty-six consecutive patients attending ophthalmologic clinics in 17 hospitals in preparation for cataract surgery were recruited. METHODS Clinical data were collected in the visit before the intervention and 6 weeks after surgery by ophthalmologists. Patients completed the questionnaires before surgery and 3 months after surgery. MAIN OUTCOME MEASURES The VF-14 and SF-36 questionnaire results obtained before surgery and 3 months after the procedure and VA before the procedure and 6 weeks afterward. RESULTS Positive mean changes in VA (+0.47) and VF-14 results (+24.03) indicated significant improvements after cataract surgery that were not reflected in changes in SF-36 domains (from 1.86 to 5.62). Responsiveness parameters demonstrated large changes in VA and VF-14 scores but not in SF-36 domains. The minimal clinically important differences (MCID) after surgery were 0.41 for VA and 15.57 for VF-14 results; the minimal detectable change (MDC) for VF-14 was 10.81. CONCLUSIONS Visual acuity and VF-14 scores, but not SF-36 scores, are appropriate instruments for capturing clinically important changes after cataract surgery. The MCID and MDC values obtained herein, although not absolute thresholds, may aid in the interpretation of changes in VA and VF-14 scores.