Conventional Clinical Measures Research Articles

SAT0356 Discriminant Capacity of Clinical Efficacy Measures, Alone or in Combination with NSAID Intake, in Detecting Anti-TNF Treatment Effect in Spondyloarthritis

BackgroundIn placebo (PBO)-controlled trials of anti-TNF therapy in spondyloarthritis (SpA), background NSAIDs are maintained at stable levels to facilitate demonstration of the anti-TNF treatment effect. In daily practice, most patients...

Clinical test responses to different orthoptic exercise regimes in typical young adults

PurposeThe relative efficiency of different eye exercise regimes is unclear, and in particular the influences of practice, placebo and the amount of effort required are rarely considered. This study measured conventional clinical measures following different regimes in typical young adults.MethodsA total of 156 asymptomatic young adults were directed to carry out eye exercises three times daily for 2 weeks. Exercises were directed at improving blur responses (accommodation), disparity responses (convergence), both in a naturalistic relationship, convergence in excess of accommodation, accommodation in excess of convergence, and a placebo regime. They were compared to two control groups, neither of which were given exercises, but the second of which were asked to make maximum effort during the second testing.ResultsInstruction set and participant effort were more effective than many exercises. Convergence exercises independent of accommodation were the most effective treatment, followed by accommodation exercises, and both regimes resulted in changes in both vergence and accommodation test responses. Exercises targeting convergence and accommodation working together were less effective than those where they were separated. Accommodation measures were prone to large instruction/effort effects and monocular accommodation facility was subject to large practice effects.ConclusionsSeparating convergence and accommodation exercises seemed more effective than exercising both systems concurrently and suggests that stimulation of accommodation and convergence may act in an additive fashion to aid responses. Instruction/effort effects are large and should be carefully controlled if claims for the efficacy of any exercise regime are to be made.

Quality of life and self-reported disability in patients with knee osteoarthritis

Objectives Osteoarthritis (OA) is the most common degenerative joint disorder and a major public health problem throughout the world. The aims of this study are to assess quality of life (QoL) in patients with knee OA using the generic instrument Short Form-36 (SF-36) and to determine its relationships with conventional clinical measures and self-reported disability.Methods Patients with knee OA (n = 112) with median age of 60 (45–76) years and 40 sex- and age-matched healthy controls were included in the study. Age, sex, body mass index (BMI), symptom duration, and Kellgren–Lawrence scores were recorded. QoL, disability, and pain were assessed using the SF-36, the Western Ontario and McMaster (WOMAC) index, the Lequesne index, and a visual analog scale (VAS) in patients. Also, QoL was assessed using the SF-36 in controls.Results Patients with knee OA had lower scores in all subgroups of SF-36 compared with controls. In patients, the SF-36 physical function (PF) and pain areas significantly correlated with effusion, VAS pain, and Lequesne and WOMAC subgroup scores (p < 0.05). The pain area of QoL did not show correlation with comorbidity with knee OA. We found that SF-36 and WOMAC pain scores were more severe in female patients.Conclusions Patients with knee OA had significantly poorer QoL compared with healthy controls. SF-36 is related to the clinical status and functional ability of patients with OA and can be used as a sensitive health status measure for clinical evaluation. Also WOMAC can be used as a sensitive measure for disability of patients with knee OA.

Quality of life and correlation with musculoskeletal problems, hand disability and depression in patients with hemodialysis

The aims of this study were to assess the health-related quality of life (HRQOL) in patients with hemodialysis using the Kidney Disease Quality of Life (KDQOL™) and to determine its relationships with conventional clinical measures, musculoskeletal problems, hand disability and depression. This study was conducted in our tertiary hospital's dialysis unit. Fifty patients under hemodialysis treatment were included in the study. HRQOL, disability, pain and depression were assessed using KDQOL-36, Duruoz hand index (DHI), visual analog scale (VAS) and Beck Depression Inventory (BDI). It was seen that all of the patients included had one or more musculoskeletal problems, the most common of which were muscle cramps, myalgias and arthralgias. Depression was the second most common accompanying disease. It was also seen that older patients had much poorer physical functioning scores, DHI scores and BDI scores than younger patients. DHI score was found to be significantly lower in men than in women. Educational level, presence of arthrosis, myalgia, bone pain, arthralgia, CTS, VAS-hand and VAS-upper extremities scales, DHI and BDI scores significantly affected both physical and mental areas of KDQOL-36, whereas age, shoulder periarthritis, mobilization scores and presence of hypertension only had effects on physical areas. Physical functioning depends mainly on the age, severity of comorbid conditions, depression, locomotor findings and hand disability of hemodialysis patients. The KDQOL-36 is related to the clinical status and functional ability of hemodialysis patients and it can be used as a sensitive health status measure for clinical evaluation.

Development of a new approach to quantifying stepping stability using ensemble empirical mode decomposition

Everyday walking is often interrupted by obstacles and changes in the environment that make gait a highly non-stationary process. This study introduces a novel measure, termed the step stability index (SSI), to quantify stepping stability under non-stationary walking conditions among older adults. This index is based on the ensemble empirical mode decomposition method. We hypothesized that a higher SSI would indicate a more stable gait pattern and could be used to assess fall risk. Accelerometer-derived signals (vertical direction) were analyzed from 39 older adults with a history of 2 or more falls in the past year (i.e., fallers) and 42 older adults who reported no falls in the previous year (i.e., controls) under three walking conditions: baseline walk with and without a harness, and obstacle course with a harness. In each condition, the subjects wore a small, light-weight sensor (i.e., a 3 dimensional accelerometer) on their lower back. The SSI was significantly higher (p≤0.05) in the controls than in the fallers in all three walking conditions. The SSI was significantly (p<0.0001) lower for both the controls and the fallers during obstacle walking compared with baseline walking. This finding is consistent with a less stable step pattern during obstacle negotiation walking. The SSI was correlated with conventional clinical measures of mobility and fall risk (the correlation coefficient, r, ranged from 0.27 to 0.73, p<0.05). These initial findings suggest that the SSI, an index based on the ensemble empirical mode decomposition, may be helpful for quantifying gait stability and fall risk during the challenges of everyday walking.

Comment: Brain amyloid increases the risk of falls

Dementia and falls are major public health problems. The current study links them by showing that “silent” CNS amyloid (PET evidence for amyloid/CSF decrease in amyloid) and CSF tau species increase the risk of falls. Falls, therefore, may be a more sensitive clue to a “system failure” than conventional clinical measures.1 Since falls are complex accidents that have multiple contributing factors, the mechanisms by which amyloid deposition increases their risk remain unclear. Strengths of the study include its prospective design with monthly falls assessment for 1 year.

Using the Speech Understanding in Noise (SUN) Test for Adult Hearing Screening1

To develop a novel speech-in-noise test for adult hearing screening-the Speech Understanding in Noise (SUN) test. The goal was to design a fast, automated, easy-to-use test to identify difficulties in speech communication. The SUN test consists of a short list of intervocalic consonants in noise presented in a forced-choice paradigm by means of a touch screen. The SUN test was developed and evaluated in an overall population of >6,000 participants. The test is available in various languages (i.e., English, French, German, and Italian) and continues to be developed in others (e.g., Spanish, Portuguese, and Mandarin). Test time was <1 min/ear. Test-retest reliability was very good. The test showed good agreement with conventional clinical measures (e.g., pure-tone testing, speech-in-noise testing, and self-reported hearing handicap). The test's sensitivity and specificity to identify disabling hearing impairment were 84% and 75%, respectively. The same results were obtained in low and high ambient noise. The SUN test is fast, repeatable, easy to use, self-explanatory, specific to the impairment, and robust to ambient noise. It may be a viable approach for adult hearing screening in clinical as well as nonclinical settings.

SAT0263 Validity of ankylosing spondylitis disease activity score (ASDAS) in patients with early spondyloarthritis

BackgroundRecently, a Working Group of the SpondyloArtrhitis International Society (ASAS) has proposed a composite disease activity score, the Ankylosing Spondylitis Disease Activity Score (ASDAS), for patients with ankylosing spondylitis (AS),...

Validity of the Ankylosing Spondylitis Disease Activity Score (ASDAS) in patients with early spondyloarthritis from the Esperanza programme

ObjectivesTo evaluate the validity of the Ankylosing Spondylitis Disease Activity Score (ASDAS) in early spondyloarthritis (SpA) in comparison with conventional clinical measures of disease activity.MethodsSix hundred and seventy-six incident cases...

Dynamic contrast-enhanced ultrasound for differential diagnosis of submandibular gland disease

Intensity-time gradients (ITGs) of contrast-enhanced ultrasound (CEUS) can be used for non-invasive monitoring of gland-preserving treatment effects in sialolithiasis-related chronic sialadenitis as well as for imaging vascularization in tumors. The aim of this clinical trial was to evaluate feasibility to distinguish different entities of submandibular gland disease including inflammatory alterations of the submandibular gland as well as benign and malignant tumors. In this prospective clinical study, ITGs in 30 patients with sialolithiasis-related chronic sialadenitis or an unilateral submandibular mass and 18 disease-free submandibular gland controls were quantitatively analyzed by CEUS using the contrast agent SonoVue. In addition, clinical complaints according to visual analog scales (VAS) were documented. VAS data documented significantly less complaints only in benign tumors compared with the other pathologies of the submandibular gland. In parallel, CEUS-derived ITGs revealed significantly reduced ITGs only in benign tumors (n = 5) compared to the controls (n = 18). Despite of comparably reduced wash-in velocities in malignant lesions (n = 3) statistical significance was not reached. Chronic sialadenitis (n = 18) and its sclerosing variant (Küttner tumor, n = 4) revealed comparable ITGs as controls. Tumors of the submandibular gland present with reduced functional microcirculatory networks comparing with healthy gland controls and chronically inflamed submandibular glands. Thus, dynamic CEUS-derived ITGs in combination with conventional clinical measures--for example VAS--appear as a safe and promising strategy for non-invasive diagnostic workup of submandibular lesions and warrant further validation in a larger set of patients.

“Prediction Is Very Hard, Especially About the Future”: New Biomarkers for Type 2 Diabetes?

With apologies to Yogi Berra, with the advent of personalized medicine, predicting who is at risk for type 2 diabetes (T2DM) will be important. T2DM is characterized by insulin resistance, often associated with obesity, and inadequate insulin secretion to overcome the insulin resistance. As the prevalence of obesity increases, so too is the prevalence of T2DM. However, depending upon their degree of obesity, only ∼25–40% of obese individuals develop T2DM (1). Trials such as the Diabetes Prevention Program (DPP) have demonstrated that intensive lifestyle and pharmacologic interventions can prevent or delay the onset of T2DM (2). Knowing who is likely to progress to T2DM will help target these interventions. With this in mind, prediction algorithms are emerging. A simple model that includes routine data from patient history and conventional clinical and biochemical measures was effective in estimating T2DM risk (3). The addition of more complicated variables, e.g., measures of insulin sensitivity and β-cell function, failed to improve the model. Our search continues for additional factors capable of strengthening risk models. One approach has been to use genetic variants associated with T2DM risk. Genome-wide association studies and other approaches have identified many T2DM susceptibility genes (4), although they account for only a modest proportion of T2DM heritability. More importantly, using them to develop genetic risk scores to help estimate T2DM risk …

Weight and width: percent fat does not improve association between adiposity and insulin

The aim of this study was to compare the independent associations of waist circumference (WC), BMI, and DEXA (%FAT) with fasting insulin among college freshmen (N=232; 18.5±0.5y, 69.8% female, 68.1% Caucasian). WC, BMI, and %FAT were 74.0±8.1 cm, 23.2±3.4 kg/m2, and 28.4±8.7%, respectively. Insulin (INS) was obtained from conventional clinical methods (M=21.9±22.1 pmol/L) and log transformed to achieve normal distribution. As expected, BMI and WC were moderately associated with %FAT via DEXA (R=.66 and .65, respectively) after controlling for sex. In a sex‐adjusted linear regression model, BMI accounted for 7.1% of the variation in INS (p&lt;0.001, R=.27). The addition of WC improved the prediction of INS, as explained variance increased by 3.8% (p&lt;0.05). However, the further addition of %FAT did not significantly improve the prediction of INS (ΔR2=1.3%, p&gt;;0.05). Our results suggest that conventional clinical anthropometric measures, BMI and WC, provide adequate predictive value when used to measure the association between adiposity and fasting insulin, and including %FAT does not significantly improve the association with metabolic risk in college freshmen.Grant Support: USDA 2008–55215‐18825

Quality of life and self-reported disability in patients with knee osteoarthritis

Osteoarthritis (OA) is the most common degenerative joint disorder and a major public health problem throughout the world. The aims of this study are to assess quality of life (QoL) in patients with knee OA using the generic instrument Short Form-36 (SF-36) and to determine its relationships with conventional clinical measures and self-reported disability. Patients with knee OA (n = 112) with median age of 60 (45–76) years and 40 sex- and age-matched healthy controls were included in the study. Age, sex, body mass index (BMI), symptom duration, and Kellgren–Lawrence scores were recorded. QoL, disability, and pain were assessed using the SF-36, the Western Ontario and McMaster (WOMAC) index, the Lequesne index, and a visual analog scale (VAS) in patients. Also, QoL was assessed using the SF-36 in controls. Patients with knee OA had lower scores in all subgroups of SF-36 compared with controls. In patients, the SF-36 physical function (PF) and pain areas significantly correlated with effusion, VAS pain, and Lequesne and WOMAC subgroup scores (p < 0.05). The pain area of QoL did not show correlation with comorbidity with knee OA. We found that SF-36 and WOMAC pain scores were more severe in female patients. Patients with knee OA had significantly poorer QoL compared with healthy controls. SF-36 is related to the clinical status and functional ability of patients with OA and can be used as a sensitive health status measure for clinical evaluation. Also WOMAC can be used as a sensitive measure for disability of patients with knee OA.

Frailty is associated with longer hospital stay and increased mortality in hospitalized older patients

With the onset of frailty, there is often a rapid, progressive, and self- perpetuating downward spiral towards death. Frailty has enormous impact on acute hospital care and has been shown to be a more effective predictor of mortality than conventional clinical measures. Hospitalized older patients admitted in medical wards at a teaching public hospital were studied to determine the prevalence of frailty; its association with anemia, congestive heart failure, clinically active tuberculosis and cognitive impairment; as well as its impact upon short-term outcome. A total of 250 older hospitalized patients were included, and their frailty status was assessed using Fried's criteria. Of these, 83 (33.2%) patients were frail, with frailty found to be significantly associated with increasing age. A lower mean level of haemoglobin (p, 0.002), higher chance of congestive heart failure (p, <0.001), lower mean MMSE score (p, <0.001), was found in frail older patients. Frail subjects had a higher median hospital stay. There were total of 5 deaths, all among the frail group. Our study showed that almost a third of hospitalized older patients are frail, and have anemia, higher frequency of CHF, cognitive impairment, longer hospital stay and higher mortality.

A simplified version of Ankylosing Spondylitis Disease Activity Score (ASDAS) in patients with ankylosing spondylitis

This study aimed to develop a simplified version of the Ankylosing Spondylitis Disease Activity Score (ASDAS). The study included consecutive patients with ankylosing spondylitis according to modified New York and/or Assessment in Ankylosing Spondylitis 2009 criteria. Sociodemographic data and characteristics of the disease (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), and Ankylosing Spondylitis Quality of Life (ASQoL)) and erythrocyte sedimentation rate (ESR) were collected. ASDAS simplified version (SASDAS) was calculated as the simple linear sum of the five components of ASDAS which include: patient global assessment using visual analogue scale, back pain (BASDAI question no. 2), peripheral pain and swelling (BASDAI question no. 3), morning stiffness (BASDAI question no. 6), and ESR in millimeters per hour, divided by 10 so as to make it equivalent to the other scale's components. Eighty-six patients were included: 69 (80.2 %) were men with a median age of 46 years and median disease duration of 19 years. SASDAS showed an excellent correlation with the ASDAS (r = 0.93). SASDAS also showed a good correlation with night pain (r = 0.60), global pain (r = 0.69), ASQoL (r = 0.70), BASFI (r = 0.75), and BASDAI (r = 0.96). Using ASDAS cut-off values previously suggested, the corresponding cut-off values for SASDAS were as follows: from 0 to 7.8 (inactive disease), from 7.9 to 13.8 (moderate disease activity), from 13.9 to 27.6 (high disease activity), and above 27.6 (very high disease activity) with optimum sensitivity and specificity. SASDAS showed an excellent correlation with conventional clinical measures of disease activity, and it can be easily calculated and is simple to use in daily clinical practice.

White-coat Hypertension on Automated Blood Pressure Measurement: Implications for Clinical Practice

In 2002, Thomas G. Pickering wrote, ‘the addition of ambulatory blood pressure monitoring to conventional clinic measurement for defining blood pressure (BP) status in clinical practice has added a new complexity to the process, because the separation of normotension and hypertension can be assessed independently by each of the two methods’[1]. The two groups of patients that arise from this classification and require special attention are individuals with white-coat hypertension and those with masked hypertension. Self measurement of BP at home is increasingly becoming an alternative to ambulatory blood pressure monitoring. The 2007 European Guidelines recommend the same threshold for daytime ambulatory BP monitoring and self measurement of blood pressure (135/85 mmHg).

Autonomic nervous system function in type 2 diabetes using conventional clinical autonomic tests, heart rate and blood pressure variability measures

Background:There are currently approximately 40.9 million patients with diabetes mellitus in India and this number is expected to rise to about 69.9 million by the year 2025. This high burden of diabetes is likely to be associated with an increase in associated complications.Materials and Methods:A total of 23 (15 male and 8 female) patients with type 2 diabetes of 10-15 years duration and their age and gender matched controls (n=23) were recruited. All subjects underwent detailed clinical proforma, questionnaire related to autonomic symptoms, anthropometry, peripheral neural examination and tests of autonomic nervous system including both conventional and newer methods (heart rate and blood pressure variability).Results:Conventional tests of cardiac parasympathetic and sympathetic activity were significantly lower in patients with diabetes compared to the controls (P<0.05). The diabetic patients group had significantly lower high frequency and low-frequency HRV when expressed in absolute units (P<0.05) and total power (P<0.01) compared to the controls.Conclusion:Data from the current study demonstrated that diabetics had both cardiac sympathetic and cardiac parasympathetic nervous system involvement. The presence of symptoms and involvement of both components of the autonomic nervous system suggest that dysfunction has been present for a while in these diabetics. There is a strong need for earlier and regular evaluation of autonomic nervous system in type 2 diabetics to prevent further complications.

Home Blood Pressure Measurement

Hypertension, the leading global risk factor for early mortality, cannot be detected or treated without accurate and practical methods of blood pressure (BP) measurement. Although home BP measurement has considerable popularity among patients, the lack of evidence needed to assure its place in modern clinical practice has hindered its widespread acceptance among physicians. This paper demonstrates that home BP measurement is more accurate than conventional clinic and ambulatory monitoring BP measurement and can be used effectively in clinical practice. On the basis of the data from different studies, it can be concluded that home BP measurement is an improvement over conventional clinic BP measurement. Home monitoring of BP is a convenient, accurate, and widely available option and may become the method of choice when diagnosing and treating hypertension. A paradigm shift is needed in BP measurement as evidence-based medicine suggests that clinic BP measurement should only be used for screening purposes.

MRI in early rheumatoid arthritis: synovitis and bone marrow oedema are independent predictors of subsequent radiographic progression

ObjectivesTo determine whether MRI and conventional (clinical and laboratory) measures of inflammation can predict 3-year radiographic changes measured by the van der Heijde Sharp score in patients with early rheumatoid...

Do clinical outcome measures assess consumer-defined recovery?

There is an international call for mental health services to become recovery-oriented, and also to use evidence-based practices. Addressing this call requires recovery-oriented measurement of outcomes and service evaluation. Mental health consumers view recovery as leading as meaningful life, and have criticised traditional clinical measures for being too disability-oriented. This study compares three measures of consumer-defined recovery from enduring mental illness: the Recovery Assessment Scale, the Mental Health Recovery Measure and the Self-Identified Stage of Recovery, with four conventional clinical measures. Correlational analyses supported the convergent validity of the recovery measures, although certain subscales were unrelated to each other. More importantly, little relationship was found between consumer-defined recovery and the clinical measures. Analyses of variance revealed that scores on the recovery measures increased across self-identified stage of recovery, but scores on most clinical measures did not improve consistently across stage of recovery. The findings demonstrate the qualitative difference between the two types of measures, supporting the claim by consumers that clinical measures do not assess important aspects of recovery. There is a need for further research and refinement of recovery measurement, including assessment of stages of recovery, with the aim of including such measures as an adjunct in routine clinical assessment, service evaluation and research.