Disease-specific Quality Of Life Questionnaire Research Articles

The Effect of Coaching on Physical Activity and Quality of Life in Children and Adolescents with Cystic Fibrosis: A Quality Improvement Pilot Study

Purpose: Physical activity is well known to improve or maintain exercise capacity and overall health in patients with cystic fibrosis (CF). However, many patients do not meet recommended guidelines for physical activity. The purpose of this study was to determine if individualized, targeted coaching could improve the levels of physical activity and quality of life in children and adolescents with CF. Subjects: Twelve children with CF, ages 7 to 17, participated in this study.Method: Each participant completed a physical activity questionnaire (PAQ) and a disease-specific quality of life questionnaire (CFQ) at baseline and three months later. The participants were given pedometers and a 10,000 step per day target. Participants also participated in discussions regarding ways to increase physical activity appropriate for their interest, abilities and age. Weekly follow-up phone calls were made to obtain pedometer counts and discuss physical activities performed. Results: Physical activity scores (PAQ) improved in 6 of 12 participants. Quality of life improved in many dimensions of the CFQ, particularly in vitality (3 of 5 improved); emotional (8 of 12 improved) and respiratory (7 of 12 improved). Conclusions: The results of this small pilot study suggest that an individualized coaching approach to physical activity in children and adolescents with CF may improve physical activity levels and improve important aspects of quality of life in some children with CF.

Quality of life in Serbian patients with Parkinson’s disease

The Parkinson's Disease Questionnaire (PDQ-39) is a well-validated British scale for the assessment of health-related quality of life (QoL) in Parkinson's disease (PD). To validate the Serbian version of the PDQ-39, while also providing additional information on the characteristics of this instrument. A total of 102 Serbian PD patients were asked to complete the PDQ-39, a disease-specific QoL questionnaire, as well as the generic, health status questionnaire (SF-36-version 1), and the 21-item Beck Depression Inventory. Neurological examination included the Hoehn and Yahr staging, Unified Parkinson's disease rating scale (UPDRS)-part III, Schwab and England scale, and the Mini-Mental State Examination. Internal consistency analysis yielded a Cronbach's alpha of 0.83. Cronbach's alpha was above 0.70 for seven out of eight subscales (range from 0.73 to 0.91). A hierarchical structure of the PDQ-39 was revealed, with one global higher-order factor and two lower-order factors. The strongest predictor of the QoL in PD was the presence of depression, while motor disability (UPDRS-part III score) additionally contributed to poor QoL. Cognitive impairment has not been correlated with poor QoL. Also, QoL measures were not different between young- (< or =50 years) and older-onset PD patients. The PDQ-39 is a reliable and valid instrument for the assessment of QoL in Serbian PD patients.

Changes in cognition and health-related quality of life with unilateral thalamotomy for Parkinsonian tremor

Cognitive functioning and health-related quality of life were assessed pre- and post-operatively in a consecutive series of 31 Parkinson’s disease patients who underwent stereotactic unilateral thalamotomy (22 left-sided, 9 right-sided) for tremor alleviation. Neuropsychological functions assessed included verbal and visual memory, language and speech production, verbal and non-verbal reasoning, and attention and working memory. Health-related quality of life measures included both general and disease-specific questionnaires. We found a statistically significant post-operative decline in phonetic verbal fluency scores for left-operated patients, as well as improvements in self-ratings of stigma and bodily discomfort on the disease-specific quality of life questionnaire. These findings suggest that thalamotomy, when indicated, has limited cognitive sequelae and may result in improved quality of life in areas specific to Parkinson’s disease.

Changes in Quality of Life After Balloon Treatment Followed by Gastric Banding in Severely Obese Patients—The Use of Two Different Quality of Life Questionnaires

Improvements in quality of life (QOL) obtained by weight loss have mainly been reported after bariatric surgery. QOL has not been investigated in surgical patients first losing weight by nonsurgical means followed by a surgical intervention and never simultaneously by two QOL-a generic and a disease-specific-questionnaires. Prospective data were obtained from 40 consecutive patients (mean age 36.6 years, body weight 142.4 kg, body mass index (BMI) 46.5 kg/m2). Two different QOL questionnaires, the generic Medical Outcomes Study Short Form-36 (SF-36) and the disease-specific Health-Related Quality of Life (HRQL) questionnaire, were evaluated at three points in time: at the start, 3 months after the placement of an intragastric balloon that remained in situ for 6 months, and 3 months after subsequent gastric banding. QOL scores revealed a significant improvement in many health domains, with an earlier improvement with the disease-specific HRQL, whereas the generic QOL questionnaire lagged behind. However, in the end, the SF-36 caught up completely to normal-weight levels, whereas some scales of the HRQL remained below these levels. Work productivity and involvement in sports improved significantly. BMI declined significantly over time, but no correlation with SF-36 and HRQL score changes was found. The QOL improved substantially independent of changes in BMI. Because of the divergent outcomes of generic and disease-specific QOL questionnaires, prospective studies should examine the sensitivity to changes of both kinds of QOL questionnaires.

Is there an alternative to pad tests? Correlation of subjective variables of severity of urinary loss to the 1-h pad test in women with stress urinary incontinence

To compare the 1-h pad test in women who have urodynamically confirmed stress incontinence (USI) with a patient-based 3-point symptom severity scale and validated quality of life (QoL) questionnaires. In all, 98 women with USI were prospectively recruited; all had a 1-h pad test and completed the validated disease-specific QoL questionnaires, including short forms of the International Consultation on Incontinence Questionnaire (ICIQ-SF), Urogenital Distress Inventory (UDI-6), and Incontinence Impact Questionnaire (IIQ-7). In addition, the severity of incontinence was determined using the Stamey grading scale, a visual analogue scale (VAS) score, and a patient-based 3-point symptom severity scale. The VAS, symptom severity scale, Stamey grade, UDI-6, and IIQ-7 failed to correlate significantly with the 1-h pad test. Only the ICIQ-SF correlated significantly with this test. The ICIQ-SF is easy to administer and, in this study, correlated best with the 1-h pad test in women with pure primary or secondary USI. It incorporates both symptom severity and QoL variables. We recommend its routine use in clinical practice.

Indikationen und Ergebnisse der Sakralnervenstimulation bei Stuhlinkontinenz

Sacral nerve stimulation (SNS) is an effective and less invasive treatment of faecal incontinence (FI). Patient selection has evolved from strict criteria to a more liberal approach, since temporary testing reliably predicts the efficacy of permanent stimulation in FI of various aetiologies. From November 2005 until June 2007, we evaluated 20 consecutive patients (17 females, 3 males) with FI by percutaneous nerve evaluation (PNE), i. e., temporary stimulation. 13 patients proceeded to a permanent implantation of a pulse generator (3 bilateral generators). 11 patients with permanent stimulation were eligible for a minimum follow-up of 3 months. Median follow-up for this group was 10 (range 3-19) months. All patients provided bowel diaries, the disease-specific quality of life questionnaire of the American Society of Colon and Rectal Surgeons (ASCRS), and the Standard Short Form Health Survey Questionnaire (SF-36) at baseline, screening and at the follow-up. The aetiologies of the FI were pelvic floor insufficiency (n = 12), history of anterior resection (n = 3), history of surgery for disk prolaps (n = 2), sphincter disruption (n = 1), history of surgery for recto-vaginal fistula (n = 1), and idiopathic (n = 1). The mean number of incontinence episodes dropped from 9.9 to 1.3 during temporary testing (p = 0.02) and to 4.5 at last follow-up (p = 0.043). The quality of life assessment showed a significant improvement in the subscale embarrassment of the ASCRS (p = 0.043). There were 2 minor postoperative complications, and 1 medium-term failure of SNS treatment. SNS is a minimally invasive and effective treatment of FI. A pragmatic approach is justified due to the possibility of temporary testing and the low rate of complications.

Quality-assessment of disease-specific quality of life questionnaires for rhinitis and rhinosinusitis

Quality-assessment of disease-specific quality of life questionnaires for rhinitis and rhinosinusitis

Parenting Style Impacts on Quality of Life in Children with Cerebral Palsy

To assess the impact of parenting style and disease severity on quality of life (QOL) in children with cerebral palsy (CP). Thirty-nine children with CP, their siblings, and their parents participated in the study. Probands and siblings, ages 6 to 18 years, completed questionnaires on parenting style (accepting, rejecting, controlling, and autonomy allowing) using the Children's Report of Parental Behavior Inventory. Parents completed generic (Child Health Questionnaire [CHQ]) and disease-specific (Pediatric Outcomes Data Collecting Instrument [PODCI]) QOL questionnaires for both children. A physician determined disease severity with the Gross Motor Function Classification System. In children with CP, parenting style positively correlated with the CHQ scores: physical summary and psychosocial summary (r = 0.40, P = .01) and family activities scale (r = 0.34, P = .03). Autonomy allowing parenting style impacted on psychosocial aspects of QOL, as reflected by CHQ scores, more than the degree of disability. In other domains of QOL, the effect of parenting style was greater than IQ, anxiety, and socioeconomic status. Parenting style is a significant factor in QOL in CP and the only known factor to impact on the psychosocial domains of the CHQ, exceeding the effect of disease severity. Because QOL is an important treatment goal in children with CP, early family interventions, particularly those focusing on parenting style, should be considered.

Development and validation of a disease-specific quality of life questionnaire (EQOL) for potentially curable patients with carcinoma of the esophagus

The objective was to develop, pretest and validate a disease-specific quality of life questionnaire for potentially curable patients with esophageal carcinoma, for use with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in order to assess the quality of life associated with the various treatment modalities available for this disease. Questionnaire development phase Patients were enrolled in three centres. Literature reviews, patients, family members, and health care professionals generated 195 items: symptoms (55); emotions (53); physical functioning (17); activities of daily living (ADL) (48); and leisure/social (22). Thirty-eight patients identified items of importance and assigned importance ratings on a 5-point Likert scale. Impact scores were calculated as frequency times mean item importance. Item impact scores<20/100 were excluded. Pearson's correlation co-efficients compared domains with the Medical Outcomes Study SF-20 (MOS SF-20). Fifteen items remained. Questionnaire validation phase EORTC QLQ-C30, Esophageal Quality of Life Questionnaire (EQOL), MOS SF-36 and a Global Rating of Change Questionnaire were completed at baseline, 1 week after baseline but prior to any treatment, 1 month, 3 months, and 6 months after treatment began. Reliability was assessed using paired samples correlations. Responsiveness was assessed between mean scores of changed and unchanged patients, and a responsiveness index was calculated. The MOS SF-36 was used for criterion validity. Construct validity included four a priori predictions. Sixty-five patients were enrolled in four centres in the validation phase. Paired samples correlations were high for all domains (0.749-0.889) indicating good reliability. Symptom, physical function and social domains were responsive to change at all time intervals (P<0.05). Emotional function was responsive at 1 and 3 months, activities of daily living (ADLs) at 1 and 6 months. Magnitude of change was significant when direction of change was stated. Between better and worse, magnitude of change was significant in all domains except at 6 months in symptoms, emotional and physical domains. The minimal clinically important difference was consistently around 0.5 for all domains. Minimal, moderate and large effect ranges were established. Only 2/16 time intervals had poor correlations with the SF-36, establishing criterion validity. Of the four a priori predictions for construct validity, only the second part of one prediction, in the emotional function domain, was not confirmed. We have developed a 15-item questionnaire (EQOL) which has good reliability, responsiveness and validity and is now in use in studies in Canadian centres with the EORTC QLQ-C30.

Motivational interviewing to change quality of life for people with chronic heart failure: A randomised controlled trial

Background Patients with chronic heart failure have a reduced quality of life due in part to their limited range of physical activity and independence. Objectives The paper examines whether a physical activity ‘lifestyle’ intervention, based on motivational interviewing, will improve quality of life at five months from baseline, compared with conventional treatment. Methods Sixty older patients with chronic heart failure were randomly assigned to either a ‘standard care’, ‘motivational interviewing’ or ‘both’ treatment groups for five months in 2002. The primary outcome measures were the Medical Outcomes Short Form-36 Health Survey, the disease-specific Minnesota Living with Heart Failure questionnaire and the Motivation Readiness for Physical Activity scale. Results There were non-significant differences between the groups at baseline for age, coronary risk factors, severity of chronic heart failure, ejection fraction, specific laboratory tests, length of hospitalisation, medication and social support. Following treatment there was a significant increase ( p < 0.05 ) for three of the dimensions of the health survey in the ‘motivational interviewing’ group. All groups improved their scores ( p < 0.05 ) on the heart failure questionnaire. Over the five month period there was a general trend towards improvements in self-efficacy and motivation scores. Conclusions This study has demonstrated that a ‘motivational interviewing’ intervention, incorporating behaviour change principles to promote physical activity, is effective in increasing selected aspects of a general quality of life questionnaire and a disease-specific quality of life questionnaire. Thus a ‘motivational interviewing’ approach is a viable option compared with traditional exercise programming. It is important to test these motivational interviewing interventions more widely, especially to match individuals to treatments.

Prospective multicenter study of quality of life before and after lower extremity vein bypass in 1404 patients with critical limb ischemia

Patients with critical limb ischemia (CLI) have multiple comorbidities and limited life spans. The ability of infrainguinal vein bypass to improve quality of life (QoL) in patients with CLI has therefore been questioned. Prospective preoperative and postoperative QoL data for patients undergoing lower extremity vein bypass for CLI are presented. A validated, disease-specific QoL questionnaire (VascuQoL) with activity, symptom, pain, emotional, and social domains and responses scored 1 (lowest QoL) to 7 (best QoL) was administered before surgery and at 3 and 12 months after lower extremity vein bypass for CLI. Changes in QoL at 3 and 12 months after lower extremity vein bypass and multiple predetermined variables potentially influencing QoL after lower extremity vein bypass were analyzed to determine the effect of lower extremity vein bypass on QoL in CLI patients. A total of 1404 patients had lower extremity vein bypass for CLI at 83 centers in the United States and Canada as part of the PREVENT III clinical trial. Surveys were completed in 1296 patients at baseline, 862 patients at 3 months, and 732 patients at 12 months. The global QoL score (mean +/- SD) was 2.8 +/- 1.1 at baseline and was 4.7 +/- 1.4 and 5.1 +/- 1.4 at 3 and 12 months, respectively. Mean changes from baseline at 3 and 12 months were statistically significant (P < .0001). Improved QoL scores extended across all domains. Diabetes and the development of graft-related events were associated with decreased improvement in QoL scores, though the mean relative change from baseline remained positive. Patients with CLI have a low QoL at baseline that is improved at 3 and 12 months after lower extremity vein bypass. QoL improvements are lower in diabetic patients and those who develop graft-related events. Successful revascularization can be expected to improve QoL in patients with CLI, with benefits that are sustained to at least 1 year.

Low risk is associated with poorer quality of life than high risk following acute coronary syndrome

Morbidity after acute coronary syndromes includes both physical and mental disorders affecting quality of life. The aim of this investigation was to study quality of life at a 3-month follow-up in patients with acute coronary syndrome, with the main objective of exploring whether unstable angina pectoris and myocardial infarction (MI) patients differ in this respect. This investigation was part of a prospective risk stratification study of consecutive patients with acute coronary syndrome of whom 814 below the age of 75 years (278 diagnosed with unstable angina pectoris and 536 with myocardial infarction) accepted an invitation to a follow-up visit 3 months after discharge. At follow-up, the patients completed the Cardiac Health Profile, a disease-specific quality of life questionnaire, designed to evaluate perceived cognitive, emotional, social and physical function. Quality of life was mainly influenced by patient characteristics and previous history. The Cardiac Health Profile scores in unstable angina pectoris patients were significantly higher (i.e. poorer quality of life) than myocardial infarction patients at the 3-month visit (34, 22, 50; median, 25th, 75th percentile and 30, 19, 44; median, 25th, 75th percentile, respectively, P=0.006). The adjusted odds ratio for a poorer quality of life in unstable angina pectoris patients in relation to myocardial infarction patients was 1.39 (95% confidence interval 1.03, 1.87; P=0.03). The highest Cardiac Health Profile scores were seen in the unstable angina pectoris patients without electrocardiogram signs of ongoing ischemia and/or elevated markers of myocardial necrosis. Patients with unstable angina pectoris, especially of the low-risk type, and therefore treated accordingly, are more likely to experience poorer quality of life following an acute hospitalization than patients with other types of acute coronary syndrome. Once myocardial infarction or high-risk unstable angina pectoris has been ruled out, these patients still require a careful and systematic follow-up.

Determining the Importance of Change in the Overactive Bladder Questionnaire

The overactive bladder questionnaire assesses symptom bother and health related quality of life in patients with overactive bladder. It has been shown to be reliable, valid and responsive. We established the minimally important difference of the overactive bladder questionnaire. Post hoc analyses from 2 clinical trials were performed. Distribution based, eg effect size, and anchor based analyses using perception of treatment benefit and clinical variables were used. The mean age of the 2 study populations was 58.8 and 58.7 years, respectively. Patients were predominantly female (51.8% and 75.1%) and white (83.9% and 87%, respectively). Half SD of the overactive bladder questionnaire symptom bother subscale was 9.1 to 9.3, and half SD of the overactive bladder questionnaire health related quality of life subscales (coping, concern, sleep and social interaction) was 9.8 to 13.2. Questionnaire subscales had moderate to large effect sizes with the largest effect sizes for symptom bother (-0.85 to -1.09). Anchor based analyses showed that significantly greater change scores were associated with greater patient perceived treatment benefit and satisfaction. The difference between change scores in patients perceiving no and little benefit was 7.4 to 16.5 for all questionnaire scales except social interaction with the majority greater than 10 points. Greater change scores were consistently associated with greater improvements in micturition diary variables. Multiple methodologies provide strong justification for the recommendation of a 10-point minimally important difference for all overactive bladder questionnaire subscales. This minimally important difference may be conservative for some subscales, although a uniform minimally important difference is recommended to facilitate interpretation of the overactive bladder questionnaire.

Development of an Unsupported Arm Exercise Test in Patients With Chronic Obstructive Pulmonary Disease

Unsupported arm exercise tests have been used to evaluate the effects of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD), but the reliability and validity of these tests are not established. We evaluated the test-retest reliability and validity of a 6-minute pegboard and ring test (PBRT) in 27 outpatients with COPD and 30 age-matched controls. We evaluated a 6-minute PBRT, subject demographics, pulmonary function and disease-specific quality of life questionnaire, and the Pulmonary Functional Status Dyspnea Questionnaire-Modified version in 27 patients with COPD. Highly significant correlation coefficients (r = .91, P < .001) were found between test and retest of PBRT scores. Statistically significant correlation coefficients were found between PBRT scores and pulmonary function tests such as FEV1% pred and FVC% pred, and activity domain and subdomain of Pulmonary Functional Status Dyspnea Questionnaire-Modified (P <or= .045). In addition, PBRT scores of healthy subjects were significantly higher than those of COPD subjects (P < .001), and were inversely related to age (P = .031). The FEV1% predicted and gender together accounted for 50% of the variance in the PBRT scores of patients with COPD. PBRT is a reliable and valid method to assess unsupported arm exercise endurance in patients with COPD.

A measure to assess the impact of Huntington's disease on the quality of life of spousal carers

The purpose of this article is to provide a current update and extended overview on a series of studies that aimed to systematically investigate the factors that enhance and compromise the lives of Huntington's disease spousal carers by using the theoretical construct of quality of life. Three exploratory studies provided evidence that spousal carers have specific difficulties maintaining their quality of life while continuing in a primary care-giving role. These initial findings prepared the way for the development of a disease-specific quality of life questionnaire for spousal carers of Huntington's disease patients, the Huntington's Disease Quality of Life Battery for Carers (HDQoL-C). A final study found that the questionnaire demonstrated good internal consistency, test-retest reliability and face validity. It is hoped that the HDQoL-C will be used in the future to quantify the caregiving experience in Huntington's disease in order to implement and assess therapeutic interventions.

A multi-centre randomized controlled trial comparing electrothermal arthroscopic capsulorrhaphy versus open inferior capsular shift for patients with shoulder instability: protocol implementation and interim performance: lessons learned from conducting a multi-centre RCT [ISRCTN68224911; NCT00251160

BackgroundThe shoulder is the most frequently dislocated joint in the body. Multiple causes and pathologies account for the various types of shoulder instability. Multi-directional instability (MDI) and multi-directional laxity with antero-inferior instability (MDL-AII) are similar in pathology, less common and more difficult to treat. These instabilities are caused by ligamentous capsular redundancy. When non-operative management fails for these patients, quality of life is significantly impaired and surgical treatment is required to tighten the ligaments and joint capsule. The current reference (gold) standard treatment for MDI/MDL-AII is an open inferior capsular shift (ICS) surgical procedure. An alternative treatment involves arthroscopic thermal shrinkage of redundant capsular tissue to tighten the joint. However, there is a lack of scientific evidence to support the use of this technique called, electrothermal arthroscopic capsulorrhaphy (ETAC). This trial will compare the effectiveness of ETAC to open ICS in patients with MDI and MDL-AII, using patient-based quality of life outcome assessments.MethodsThis study is a multi-centre randomized clinical trial with a calculated sample size of 58 patients (p = 0.05, 80% power). Eligible patients are clinically diagnosed with MDI or MDL-AII and have failed standardized non-operative management. A diagnostic shoulder arthroscopy is performed to confirm eligibility, followed by intra-operative randomization to the ETAC or ICS surgical procedure. The primary outcome is the disease-specific quality of life questionnaire (Western Ontario Shoulder Instability Index), measured at baseline, 3, 6, 12 and 24 months. Secondary outcomes include shoulder-specific measures (American Shoulder and Elbow Surgeons Score and Constant Score). Other outcomes include recurrent instability, complications and operative time.The outcome measurements will be compared on an intention-to-treat basis, using two-sample independent t-tests to assess statistical significance. A Generalized Estimated Equations (GEE) analysis will determine whether there is an effect over time.DiscussionThis ongoing trial has encountered unexpected operational and practical issues, including slow patient enrollment due to high intra-operative exclusion rates. However, the authors have a greater understanding of multi-directional laxity in the shoulder and anticipate the results of this trial will provide the medical community with the best scientific clinical evidence on the efficacy of ETAC compared to open ICS.

Development of a disease-specific quality of life questionnaire for children &amp; adolescents with idiopathic thrombocytopenic purpura (ITP-QoL)

Quality of life (QoL) assessment in children with coagulation disorders is a relatively unstudied area. While hemophilia-specific questionnaires (such as Haemo-QoL) are available, no instrument for children with idiopathic thrombocytopenic purpura (ITP) has been validated yet. A disease-specific questionnaire for children with ITP was therefore developed (ITP-QoL) in three phases: (a) a preparatory phase; (b) a developmental phase; (c) a pilot testing phase. Since dimensions of Haemo-QoL were considered important for children with ITP, items were adapted, reformulated and additional dimensions were included. Two age-group versions were designed for children (aged 3-7, 8-18 years) and parents in Italian, German, and Swedish languages and were pilot tested.

Prognostic Factors for Successful Percutaneous Tibial Nerve Stimulation

ObjectiveIn sacral as well as tibial nerve stimulation test stimulation is the main prognostic factor for success. In our study we tried to identify prognostic patient characteristics to improve patient selection for neuromodulation therapy. MethodsPTNS was applied to 132 patients in 8 study centers (51 men, 81 women, mean age of 53 years (range: 21–82)). 83 patients were treated for overactive bladder, 16 for non-obstructive urinary retention and 33 for chronic pelvic pain. All patients had to fill out micturition or pain diaries, as well as quality of life questionnaires before and after treatment. Patient characteristics were evaluated for their prognostic value for successful outcome of neuromodulation therapy with use of logistic regression. ResultsObjective success was seen in 32.6% of patients, subjective success in 51.5%. Most evaluated clinical parameters proved not to be of prognostic value. A history of sexual and/or physical abuse was found in 12 of 103 interviewed patients, but did not alter PTNS treatment outcome.However, a low total score at baseline in the SF-36 questionnaire proved to be predictive for not obtaining objective (OR 0.444 [95% CI: 0.198–0.996], p=0.04) or subjective success (OR 0.424 [CI: 0.203-0.887], p=0.02). Especially patients with a low SF-36 Mental Component Summary were prone to fail neuromodulation therapy: OR 0.123 (95% CI: 0.273–0.552), p=0.006 for objective success. These patients also scored worse on disease-specific quality of life questionnaires, although they had no different disease severity compared to patients with good mental health. ConclusionBad mental health as measured with the SF-36 Mental Component Summary does not depend on symptom severity and is a negative predictive factor for success of percutaneous tibial nerve stimulation. It therefore might be used as a tool for better patient selection in neuromodulation therapy.

Comparison of Performance of Two Clinical Scales To Diagnose the Post-Thrombotic Syndrome: Correlation with Patient-Reported Disease Burden and Valvular Reflux.

Background and Objectives: There is no objective, criterion standard test to diagnose the post thrombotic syndrome (PTS). Two clinical scales have been used to classify deep vein thrombosis (DVT) patients as having or not having the PTS: the Villalta scale and the Ginsberg measure. Differences in test characteristics of these measures could help explain differing rates of PTS reported after DVT. During a Canadian prospective cohort study of long-term outcomes after DVT (The VETO Study), we carried out a substudy to evaluate agreement between the Villalta and Ginsberg measures with regard to (1) proportion of patients classified as having PTS; (2) relation to patient-reported quality of life (QOL); and (3) correlation with venous valvular reflux, a physiological indicator of chronic venous disease.Methods: For this substudy, 259 VETO patients were assessed for ipsilateral PTS at the 1 year follow-up visit using both the Villalta scale (grades the severity of 5 symptoms and 6 signs from 0–3; a summed total score of ≥5 indicates PTS, and >14 or presence of ulcer indicates severe PTS) and the Ginsberg PTS measure (PTS defined by the presence of daily leg pain and swelling for ≥ 1 month, occurring 6 months or more after DVT, made worse by standing/walking and relieved by rest/leg elevation). Patients also completed generic (SF-36) and disease-specific (VEINES-QOL) QOL questionnaires and underwent a standardized ultrasound assessment for ipsilateral popliteal venous valvular reflux. We compared the proportion of patients classified as having PTS with each measure and assessed associations with QOL and valvular reflux.Results: Proportion of patients classified as having PTS was 96/259 (37%) (5/96 severe) with the Villalta scale and 21/259 (8.1%) with the Ginsberg measure (kappa 0.22; 95% CI 0.13, 0.32). Agreement between measures was better for severe PTS than for any PTS. For both measures, generic and disease specific-QOL scores were significantly lower (i.e. poorer QOL) in patients with vs. without PTS; however, QOL was worse in patients with Ginsberg-PTS than in patients with Villalta-PTS. Reflux was not significantly associated with PTS for either measure.Conclusions: The proportion of patients classified as having PTS was more than 4-fold higher with the Villalta measure than with the Ginsberg measure. While both measures showed a graded association with QOL, patients with Ginsberg-PTS had poorer QOL and higher mean Villalta scores, indicating that the Ginsberg measure identifies more severe disease. The presence of reflux was not discriminating for the diagnosis of PTS with either measure.Comparison of Villalta and Ginsberg PTS measuresVillalta PTSGinsberg PTSMean (SD)YESNOpYESNOpVillalta score8.3 (3.1)1.6 (1.4)<.00019.2 (3.5)3.6 (3.4)<.0001SF-36 MCS (mental)49.5 (12.1)54.2 (8.3).000747.3 (12.6)52.9 (9.7)0.01SF-36 PCS (physical)39.7 (11.0)49.1 (10.0)<.000135.0 (12.4)46.8 (10.8)<.0001VEINES-QOL48.6 (6.1)56.2 (2.5)<.000144.1 (5.6)54.2 (5.1)<.0001Reflux present (%)54.6%44.0%0.1252.6%46.2%0.59

Development, validation and clinical use of the FLQA-l, a disease-specific quality of life questionnaire for patients with lymphedema

It is known from clinical practice that lymphatic diseases can be associated with reductions of quality of life (QoL). Due to the lack of validated methods, only few studies however have systematically investigated the QoL in lymphedema. The aim of the study was 1) to develop a standardized QoL questionnaire specific for lymphedema and 2) to assess the QoL in these patients. We developed and tested the FLQA-l, a novel QoL questionnaire developed specific for use in lymphedema on the basis of the previously validated FLQA vein questionnaire. The questionnaire consists of 92 items that refer to the following scales: Physical status, everyday life, social life, emotional well-being, treatment, satisfaction and profession/household. 392 patients with primary (n = 246) and secondary (n = 146) lymphedema were included in the validation study. The FLQA-l showed good internal consistency; Cronbach's alpha was higher than 0.75 in all scales. There were no floor and ceiling effects and satisfactory item selectivity. The test-retest reliability, sensitivity to change and convergent validity with other psychometric instruments were satisfactory. Clinically, patients with lymphedema showed markedly impaired QoL in all fields, compared to persons with early stage venous insufficiency, and comparable reductions of QoL, compared to patients with venous leg ulcer. These data indicate that the FLQA-l is a reliable and valid questionnaire for the assessment of QoL in lymphedema. Since the QoL is impaired in many patients with lymphedema, QoL evaluation may be helpful for clinical diagnostics as well as for outcome measurement of specific edema therapy.