Responsiveness and calibration of the general well-being adjustment scale in patients with hypertension

We examined the discriminant ability and responsiveness of the General Well-Being Adjustment Scale in patients enrolled in a randomized clinical trial of antihypertensive therapy. We also tried to translate the effects of physical symptoms on general well-being. This secondary analysis used demographic, clinical, physical symptom, and general well-being data for 545 white, male hypertensive patients. General well-being was measured by the General Well-Being Adjustment Scale (GWB) collected on 2 occasions over 8 weeks of treatment. Patients with any one of 14 physical symptoms or problems, compared to those without symptoms, had lower GWB scores (p < 0.003 to p < 0.0001). Decreases of 2.83–8.76 points in GWB scores were observed in patients developing physical symptoms over the 8 week study period (p < 0.05 to p < 0.0001). These effects were demonstrated in patients developing cold sensitivity, sexual problems, chest pain, shortness of breath, loss of taste, nausea, hot or cold spells, numbness and tingling, dry mouth, blurred vision, and dizziness. We conclude that the GWB is responsive to clinically meaningful changes in symptoms and may provide a more complete evaluation of the effects of medical treatment. The GWB is a valid and responsive measure of health status outcomes in the evaluation of antihypertensive treatment.     

Danish version of the Oswestry disability index for patients with low back pain. Part 2: Sensitivity, specificity and clinically significant improvement in two low back pain populations

In studies evaluating the efficacy of clinical interventions, it is of paramount importance that the functional outcome measures are responsive to clinically relevant change. Knowledge thereof is in fact essential for the choice of instrument in clinical trials and for clinical decision-making. This article endeavours to investigate the sensitivity, specificity and clinically significant improvement (responsiveness) of the Danish version of the Oswestry disability index (ODI) in two back pain populations. Two hundred and thirty three patients with low back pain (LBP) and/or leg pain completed a questionnaire booklet at baseline and 8 weeks follow-up. Half of the patients were seen in the primary (PrS) and half in the secondary sectors (SeS) of the Danish Health Care System. The booklet contained the Danish version of the ODI, along with the Roland Morris Questionnaire, the LBP Rating Scale, the SF36 (physical function and bodily pain scales) and a global pain rating. At follow-up, a 7-point transition question (TQ) of patient perceived change and a numeric rating scale relating to the importance of the change were included. Responsiveness was operationalised using three strategies: change scores, standardised response means (SRM) and receiver operating characteristic (ROC) analyses. All methods revealed acceptable responsiveness of the ODI in the two patient populations which was comparable to the external instruments. SRM of the ODI change scores at 2 months follow-up was 1.0 for PrS patients and 0.3 for SeS (raw and percentage). A minimum clinically important change (MCID) from baseline score was established at 9 points (71%) for PrS patients and 8 points (27%) for SeS patients using ROC analyses. This was dependable on the baseline entry score with the MCID increasing with 5 points for every 10 points increase in the baseline score. We conclude that the Danish version of the ODI has comparable responsiveness to other commonly used functional status measures and is appropriate for use in low back pain patients receiving conservative care in both the primary and secondary sector.     

Age-related profile of cardiovascular reactivity to norepinephrine and angiotensin II in normal and hypertensive man

Summary The interrelationships among age, cardiovascular pressor reactivity to intravenously infused norepinephrine (NE) or angiotensin II, and endogenous plasma NE or renin (PRA) levels were evaluated in 31 normal subjects and 37 patients with essential hypertension. In normal subjects both angiotensin II pressor dose and PRA decreased progressively with aging. Angiotensin pressor dose correlated positively with PRA (r=0.41,P<0.025) and inversely with age (r=–0.46,P<0.02). NE pressor dose and basal plasma NE were also positively correlated (r=0.53,P<0.005), but the two factors remained largely unchanged with aging. Findings in essential hypertension differed in certain aspects. Angiotensin II pressor dose did not correlate with either basal PRA or age; and pressor doses of NE and angiotensin II tended to be lower in some patients than in normal subjects. These findings indicate that aging is accompanied by a physiologic increase in cardiovascular reactivity to angiotensin II, probably due to a concomitant decrease in circulating renin. The dissociation between angiotensin pressor dose and PRA in essential hypertension suggests an interference from an other factor.This work was supported by the Swiss National Science Foundation     

辽宁省农村地区卫生系统反应性评价与分析

目的2000年世界卫生组织首次将卫生系统反应性作为卫生绩效评价的三大指标之一,它重点强调卫生系统在多大程度上满足了人群对卫生系统改善非健康方面的普遍的合理的期望.本次调研旨在了解与评价辽宁省农村地区的反应性水平,寻找差距,提出改善的对策.方法采用世界卫生组织2000年对191个成员国进行的卫生系统反应性调查问卷(KIS)的方法,对8个方面的具体问题又采用Likert量化法,由调查对象根据就医时的感觉进行回答.结果我省农村地区的反应性水平为6.56,低于山东省和上海市,但又优于35个国家的平均水平.在反应性的总体评价中,8个方面由高到低的排序依次为社会支持、保密性、尊重、选择医护人员、候诊时的及时关注、维护个人自主权、沟通交流和就医环境的舒适度.结论公众对卫生系统反应性水平的评价基本上是肯定的,但在就医环境的舒适度、尊重患者的自主权和参与治疗方案的决策权、满足患者就医时对健康相关问题的咨询权等方面仍有待于进一步提高.     

Responsiveness of the generic EQ-5D summary measure compared to the disease-specific EORTC QLQ C-30

Introduction: We investigated whether the sensitivity of the generic health-related quality of life (HRQoL) EQ-5D summary measure (or index) to detect changes over time in a clinical setting is comparable with that of a disease-specific HRQoL questionnaire. Methods: Patients with liver metastases (n = 75) filled out the five domains of the EQ-5D self-classifier, the EQ VAS, and the EORTC QLQ C-30 (a disease-specific (cancer) HRQoL questionnaire). The HRQoL instruments were completed before intervention, and 1/2 month and 3 and 6 months after intervention. Three analyses were performed. First, the EQ-5D index (based on self-classification) was compared to the EQ VAS. Second, the EQ-5D domains were compared to corresponding EORTC QLQ C-30 scales. Third, EQ-5D index and EQ VAS were compared with the EORTC QLQ C-30 global health-status scale. Effect size was chosen as the metric of responsiveness. Results: The EQ-5D index was slightly less responsive than the EQ VAS. Overall, the responsiveness of the EQ-5D index and EQ VAS was equal to the EORTC QLQ C-30 global health-status scale. Conclusion: Despite its generic principle and the apparent crudeness of its framework, the responsiveness of the EQ-5D proved to be comparable to that of a disease-specific HRQoL questionnaire in this specific clinical setting.     

Psychometric properties of the Dutch Short Musculoskeletal Function Assessment (SMFA) questionnaire in severely injured patients

In this cross-sectional study the psychometric properties are examined of the adapted Dutch translation of the Short Musculoskeletal Function Assessment (SMFA) questionnaire in severely injured patients (ISS > 15).Patients and methodsPatients (N = 173) completed the SMFA, the World Health Organization Quality of Life assessment instrument-BREF (WHOQOL-BREF), the Dutch Impact of Event Scale (IES), the Hospital Anxiety and Depression Scale (HADS) and the Cognitive Failure Questionnaire (CFQ). The Abbreviated Injury Score and the Injury Severity Score were established to determine the injured body area and the severity of the injuries. Exploratory factor analysis (method: PAF) was performed. Correlations were calculated between our SMFA factors and scores on the WHOQOL-BREF, IES, HADS and CFQ. The SMFA scores of the factors Upper extremity dysfunction and Lower extremity dysfunction were compared between subgroups of patients with and without injuries in respectively the upper extremities and the lower extremities. For responsiveness analysis, data were compared with the baseline SMFA measurement of a reference group.ResultsA three-factor structure was found: Lower extremity dysfunction, Upper extremity dysfunction, and Emotion. Strong correlations between the SMFA and the other questionnaires were found. Patients with injury of the lower extremities had significantly higher scores on the factor Lower extremity dysfunction than patients without injury of the lower extremities (p = 0.017). In none of the factors, a significant difference in mean scores was found between patients with and without injury of the upper extremities. Severely injured patients had significantly higher SMFA scores than the reference group (p < 0.001).ConclusionThe adapted Dutch translation of the SMFA showed good psychometric properties in severely injured patients. It appeared to be useful to get a general overview of patients’ Health Status as well as patients’ Health Related Quality Of Life.     

Psychometric properties of the Neck OutcOme Score,Neck Disability Index,and Short Form–36 were evaluated in patients with neck pain

ObjectiveTo assess reliability, construct validity, responsiveness, and interpretability for Neck OutcOme Score (NOOS), Neck Disability Index (NDI), and Short Form–36 (SF-36) in neck pain patients.Study Design and SettingInternal consistency was assessed by Cronbach alpha. Test-retest reliability was evaluated by intraclass correlation coefficient (ICC), and measurement error was estimated from the standard error of measurement. Responsiveness was assessed as standardized response mean (SRM) and interpretability from the minimal important difference (MID). Construct validity was tested correlating subscale scores from NOOS and SF-36 and NDI items.ResultsAt baseline, 196 neck pain patients were included. Cronbach α was adequate for most NOOS subscales, NDI, and SF-36 with few exceptions. Good to excellent reliability was found for NOOS subscales (ICC 0.88–0.95), for NDI, and for SF-36 with few exceptions. For NOOS, minimal detectable changes varied between 1.1 and 1.9, and construct validity was supported. SRMs were higher for NOOS subscales (0.19–0.42), compared to SF-36 and NDI. MID values varied between 15.0 and 24.1 for NOOS subscales.ConclusionsIn conclusion, the NOOS is a reliable, valid, and responsive measure of self-reported disability in neck pain patients, performing at least as well or better than the commonly used SF-36 and NDI.     

关键知情人对河南省社区卫生服务机构反应性的评价研究

目的:了解河南省社区卫生服务机构反应性水平。方法:采用制定的《河南省社区卫生反应性调查表(关键知情人)》问卷,调查社区卫生服务机构关键知情人。采用多输入优序图列法确定河南省社区卫生服务机构反应性各维度权重,采用模糊综合评价法评价反应性水平,采用反应性不平等指数测量反应性分布。结果:共调查有效关键知情人431位。问卷各维度Cronbachα系数均大于0.623,总量表Cronbachα系数为0.850;重测信度的各维度相关系数均大于0.907。反应性水平与分布指数分别为8.33和0.2744,各维度重要性排序为:及时关注尊严基础设施交流保密性社会支持选择性自主性。关键知情人认为脆弱人群在社区卫生机构有时或经常受到不公平对待的比例约为50%。结论:关键知情人认为河南省社区卫生服务机构的反应性水平总体较高,反应性分布比较均衡。但认为在基础设施、对患者的隐私保护、与患者的交流沟通等方面存在很大不足。     

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.