Accurately measuring the quality and effectiveness of lumbar surgery in registry efforts: determining the most valid and responsive instruments

Background contextProspective registries have emerged as a feasible way to capture real-world care across large patient populations. However, the proven validity of more robust and cumbersome patient-reported outcomes instruments (PROis) must be balanced with what is feasible to apply in large-scale registry efforts.PurposeTo determine the relative validity and responsiveness of common PROis in accurately determining effectiveness of lumbar fusion for degenerative lumbar spondylolisthesis in registry efforts.Study designProspective cohort study.Patient sampleFifty-eight patients undergoing transforaminal lumbar interbody fusion (TLIF) for degenerative lumbar spondylolisthesisOutcome measuresPatient-reported outcome measures for pain (numeric rating scale for back and leg pain [NRS-BP, NRS-LP]), disability (Oswestry Disability Index [ODI]), general health (Short Form [SF]-12), quality of life (QOL) (EuroQol five dimensions [EQ-5D]), and depression (Zung depression scale [ZDS]) were assessed.MethodsFifty-eight patients undergoing primary TLIF for lumbar spondylolisthesis were entered into an institutional registry and prospectively followed for 2 years. Baseline and 2-year patient-reported outcomes were assessed. To assess the validity of PROis to discriminate between effective and noneffective improvements, receiver operating characteristic curves were generated for each outcomes instrument. An area under the curve (AUC) of ≥0.80 was considered an accurate discriminator. The difference between standardized response means (SRMs) in patients reporting meaningful improvement versus not was calculated to determine the relative responsiveness of each instrument.ResultsFor pain and disability, ODI had AUC=0.94, suggesting it as an accurate discriminator of meaningful improvement. Oswestry Disability Index was most responsive to postoperative improvement (SRM difference: 2.18), followed by NRS-BP and NRS-LP. For general health and QOL, SF-12 physical component score (AUC: 0.90), ZDS (AUC: 0.89), and SF-12 mental component score (AUC: 0.85) were all accurate discriminators of meaningful improvement, however, EQ-5D was most accurate (AUC: 0.97). EuroQol five dimensions was also most responsive (SRM difference: 2.83).ConclusionsFor pain and disability, ODI was the most valid and responsive measure of effectiveness of lumbar fusion. Numeric rating scale-BP and NRS-LP should not be used as substitutes for ODI in measuring effectiveness of care in registry efforts. For health-related QOL, EQ-5D was the most valid and responsive measure of improvement, however, SF-12 and ZDS are valid alternatives with less responsiveness.     

Longitudinal construct validity and responsiveness of measures of walking capacity in individuals with lumbar spinal stenosis

Background contextWalking capacity is a primary outcome indicator for individuals with lumbar spinal stenosis (LSS). Therefore, there is a demand for psychometrically sound measures of walking that are responsive to change.PurposeThe primary objective of this study was to examine longitudinal construct validity of the Physical Function Scale of the Swiss Spinal Stenosis Questionnaire (PF Scale), the Oswestry Disability Index (ODI), and the walking capacity items from these scales specifically for the assessment of walking capacity in LSS using the objective Self-Paced Walking Test (SPWT) as the external standard. A secondary objective was to examine responsiveness of measures of walking using a self-reported walking capacity change scale as the external criterion standard.Study designPatients were prospectively enrolled.Patient sampleTwenty-six patients were included in this study (17 women and 9 men), with an average age of 68.5 years (SD, 9.2). All participants had LSS diagnosed by a spine specialist surgeon based on both clinical examination and imaging, as well as self-reported walking limitations (neurogenic claudication).Outcome measuresThe self-reported outcome measures included in this study were PF Scale, ODI, and self-reported walking capacity change score.Functional measuresThe functional measure used in the study was SPWT.MethodsLongitudinal construct validity was assessed using the correlational method. Internal responsiveness was examined using Guyatt responsiveness index and external responsiveness using receiver operating characteristic analysis. Change in the SPWT and the self-reported walking capacity change score were used as external criteria for the analysis.ResultsThe highest correlations with change in the SPWT were 0.78 for the ODI walking item and 0.78 for the walking capacity change score. Changes in the PF Scale and ODI score were correlated with change in the criterion SPWT at r=0.56 and r=0.70, respectively. There were no differences observed between the PF Scale and ODI for any of the responsiveness indices.ConclusionsThe PF Scale, ODI, and walking capacity change score are able to detect changes in walking capacity in people with LSS. The individual walking capacity item from the ODI appears to be the most valid and responsive to changes in measured walking and may be a reasonable alternative for measuring walking when an objective test such as the SPWT is not feasible.     

Reliability and Validity of Digital Imaging as a Measure of Schoolchildren's Fruit and Vegetable Consumption

BackgroundAs more and more interventions aim to increase schoolchildren's fruit and vegetable (FV) consumption, less resource-intensive yet valid alternatives to weighed plate waste (WPW) are needed for assessing dietary intake.ObjectivesWe aimed to test the reliability and validity of digital imaging (DI) and digital imaging with observation (DI+O) in assessing children's FV consumption during school lunch.DesignFV consumption (in grams) was assessed on lunch trays from third- to fifth-grade children over eight visits (31 to 68 trays collected per visit) to compare WPW with DI and DI+O.SettingTwo elementary schools (327 and 631 students enrolled, respectively).Main outcome measuresInterobserver reliability of DI. Validity of DI and DI+O compared against WPW.Statistical analysesReliability was assessed by percent agreement and intraclass correlation coefficients (ICCs). Validity was assessed by Pearson correlations, paired t tests, and Bland-Altman plots.ResultsReliability was acceptable for DI; percent agreement was 96% and the ICC was 0.92. FV consumption assessments by DI and WPW (n=159) were highly correlated (r=0.96; P<0.001). Mean FV consumption using DI (96.7 g) was within 1.0 g of WPW and not significantly different from WPW (P=0.56), and Bland-Altman limits of agreement for individual-tray FV consumption were –32.9 to 31.3 g. FV consumption assessments by DI+O and WPW were highly correlated (r=0.98; P<0.001). Mean FV consumption using DI+O (99.3 g) was within 1.0 g of WPW and not significantly different from WPW (P=0.38), and limits of agreement for individual-tray FV consumption were –25.0 to 26.8 g.ConclusionsDI was reliable for assessing children's FV consumption during school lunch. DI and DI+O were valid for assessing mean consumption but less precise for estimating individual-tray consumption. Valid estimations of mean FV consumption were achieved using DI without cafeteria observations, thereby reducing labor and time. Thus, DI is especially promising for assessing children's mean FV consumption during school lunch.     

牡丹皮饮片的有效期研究

目的：进行中药材有效期方法研究。方法选用易散失气味、易变色的牡丹皮饮片作为研究对象,通过经典恒温实验和留样观察实验,用紫外色谱法测定其有效成分丹皮酚含量。推导出牡丹皮饮片中丹皮酚含量变化规律。结果在经典恒温实验中,丹皮酚含量变化符合一级反应规律。牡丹皮在20℃贮存,丹皮酚含量变化速度常数K20℃=1.194＆#215;10-4、该批牡丹皮的有效期为226 d。经典恒温实验推导的结果与留样观察有效成分含量的变化结果基本一致。结论用经典恒温实验预测牡丹皮饮片有效期的方法可行,得出有效期结论可靠。     

Validity and Reliability of the Modified Manchester Health Questionnaire in Assessing Patients With Fecal Incontinence

PURPOSE To date, no measures of fecal incontinence severity or its impact on quality of life have been validated for telephone interview. This study was designed to 1) compare responses of a self-administered and a telephone-administered Fecal Incontinence Severity Index; 2) compare a self-administered Fecal Incontinence Quality of Life Scale to the Manchester Health Questionnaire after modifying the latter for telephone administration and American English (Modified Manchester Health Questionnaire); 3) assess test-retest reliability of the telephone-administered Modified Manchester Health Questionnaire; and 4) assess the internal consistency of the Modified Manchester Health Questionnaire subscales.METHODS Consecutive, English-speaking, nonpregnant females known to have fecal incontinence were invited to participate. Two validated paper questionnaires accompanied the letter informing them of the study: Fecal Incontinence Severity Index and Fecal Incontinence Quality of Life Scale. Consenting patients were contacted for the initial telephone administration of the Modified Manchester Health Questionnaire, and patients who agreed to continue the study were contacted for a repeat telephone administration of the Modified Manchester Health Questionnaire two to four weeks after completing the first interview.RESULTS Fifty-one females were invited to participate in the study; however, 13 declined or were ineligible. Thirty females, aged 49.3 ± 10.3 years, returned self-administered questionnaires and completed the first telephone interview, and 21 completed a second telephone interview after an average interval of 23 days. The telephone-administered Fecal Incontinence Severity Index scores were significantly lower than those yielded by the self-administered Fecal Incontinence Severity Index, (6.19 vs. 9.85; P < 0.001), but the telephone and written administrations were significantly correlated (r = 0.5; P < 0.02). Correlations between the Modified Manchester Health Questionnaire quality of life subscales and the paper Fecal Incontinence Quality of Life subscales ranged from 0.6 to 0.9 (median, r = 0.81). The correlation between the total score for the Fecal Incontinence Quality of Life and the total score for the Modified Manchester Health Questionnaire quality of life scales was 0.93 (P < 0.001). Test-retest reliability for the eight Modified Manchester Health Questionnaire subscales ranged from 0.55 to 0.98 (median, r = 0.83), and test-retest reliability for the two telephone administrations of the Fecal Incontinence Severity Index was r = 0.75. Cronbachs alpha for the eight Modified Manchester Health Questionnaire subscales ranged from 0.79 to 0.92 (median, alpha = 0.85).CONCLUSIONS Telephone-administered versions of the Modified Manchester Health Questionnaire showed good-to-excellent validity, internal consistency, and test-retest reliability. The telephone-administered Fecal Incontinence Severity Index yielded lower severity scores than the written Fecal Incontinence Severity Index; however, the difference (3.66 units) was not clinically significant.Supported by Pelvic Floor Disorders Network.Supported by NICHD grants U10 HD41249, U10 HD41268, U10 HD41248, U10 HD41250, U10 HD41261, U10 HD41263, U10 HD41269, U10 HD41267.Presented at the American Urogynecologic Society, Hollywood, Florida, September 11 to 13, 2003.Reprints are not available.     

药品有效期管理的实践与思考

目的 基层医院病区药房药品有效期精细化管理的实践探讨。方法 通过6年实践,采取药品有效期精细化管理的三统一实践方式。结果 实践过程精细流畅,保障患者用药安全有效,过期药品报损率控制在较低范围。结论 药品有效期精细化管理很有必要。     

A comparison of the validity of two indirect utility instruments as measures of postoperative recovery

Background

Cost-effectiveness analyses of surgical interventions require valid measures of postoperative recovery. The objective of this study was to compare the validity of two indirect utility instruments, the Short Form 6D (SF-6D) and EuroQol 5D (EQ-5D), as measures of postoperative recovery.

Materials and methods

A prospective cohort of patients undergoing elective colorectal resection at two university-affiliated institutions from October 2012–October 2013 completed the SF-6D and EQ-5D (including the EQ-visual analog scale [EQ-VAS]) at baseline (before surgery), and at 4 and 8 wk after surgery. Responsiveness and construct validity were assessed through a priori hypotheses.

Results

A total of 165 patients were included. The SF-6D was the most responsive to the expected postoperative changes at 4 and 8 wk compared with the EQ-5D and the EQ-VAS. The 4-wk SF-6D, EQ-5D, and EQ-VAS discriminated between patients with and without complications after controlling for confounders with adjusted mean differences of −0.070 (95% confidence interval [CI] −0.126 to −0.015), −0.133 (95% CI −0.231, −0.030), and −7.91 (95% CI −14.77, −1.04), respectively. Mean SF-6D and EQ-5D values were significantly different from the US population norms at all time points, but the magnitude of change was highest for the SF-6D. The strength of correlation between all three instruments was moderate at all time points (r = 0.550–0.684, all P < 0.05).

Conclusions

The SF-6D preference-based health index appears to be a more valid measure of postoperative recovery than the EQ-5D and EQ-VAS in surgical cost-effectiveness analyses.     

Cross-Cultural Adaptation,Reliability, and Validity of the Revised Korean Version of Ruminative Response Scale

Objective

Rumination is a negative coping strategy defined as repetitive and passive focusing on negative feelings such as depression. The Ruminative Response Scale (RRS) is a widely-used instrument to measure rumination, but there is continuing argument about the construct validity of the RRS, because of probable overlap between the measurement of depression and that of rumination. The RRS-Revised (RRS-R), which removed 12 items of the RRS, is suggested as a more valid instrument for measuring rumination. Therefore, we translated RRS-R into Korean and explored the reliability, validity and factor structure in patients with major depressive disorders.

Methods

Seventy-nine patients with major depressive disorder took the Korean version of RRS, RRS-R, State Trait Anxiety Inventory, Beck Depression Inventory and Penn State Worry Questionnaire. We performed exploratory factor analysis of RRS-R, and tested construct validity, internal reliability and test-retest reliability.

Results

The internal and test-retest reliability of RRS-R was high. Factor analysis revealed that RRS-R is composed of two factors. ''Brooding'' factor explained 56.6% and ''Reflection'' factor explained 12.5%. RRS-R, especially ''Brooding factor'', was highly correlated with other clinical symptoms such as depression, anxiety and worry.

Conclusion

In this study, we find out the RRS-R is more reliable and valid than the original RRS in Korean patients with depression because the RRS-R is free from the debate about the overlap of item with BDI. We also revealed that ''Brooding'' is highly correlated with depressive symptoms. RRS-R may be a useful instrument to explore the implication of ''Brooding'' in depression.     

常用精神健康筛查量表简介及其信度、效度比较

在物质生活日益丰盈的时代,精神健康逐渐成为人们关注的焦点。为了准确有效地筛查出存在精神障碍的人群,介绍了几种常用精神健康筛查量表,并对其信度、效度、灵敏度、特异度、优缺点等进行比较。     

Comparing patient generated blood glucose diary records with meter memory in type 2 diabetes

Aim

To assess agreement between meter and diary self monitoring of blood glucose (SMBG) records, over a year, in a sample of patients with type 2 diabetes.

Methods

Meter and diary records were available, for 95 individuals, who took part in the Efficacy of self monitoring of blood glucose in patients with newly diagnosed type 2 diabetes study.Pearson's correlation coefficient was used to explore the relationships between the types of error. Maximum likelihood estimation was used to explore changes over time through a structural equation modelling approach. Paired samples t-tests were used to determine if the presence of errors led to a significant difference between the mean diary and meter SMBG concentrations or coefficients of variation. Multiple regression was used to explore possible predictors of the error indices.

Results

Mean over-reporting, under-reporting, concordance and overall reliability were 8.4%, 10.0%, 83.5% and 71.3%, respectively. The first week of monitoring had significantly more under-reporting, over-reporting and less concordance and overall reliability than subsequent weeks. The majority of concordance errors were not clinically significant. Those that were, tended to occur during the first three months of monitoring. Participants’ at one trial site were significantly more likely to have recording errors than those at the largest site.

Conclusions

Error levels were similar to those described previously in type 1 diabetes and there was a suggestion of an initial learning curve for record keeping. For some individuals diary records would not be considered acceptable if held to the same standards as blood glucose meters.