Psychometric evaluation of the hepatitis C virus patient-reported outcomes (HCV-PRO) instrument: validity,responsiveness, and identification of the minimally important difference in a phase 2 clinical trial

Purpose

To describe the psychometric properties and identify the minimally important difference (MID) of the hepatitis C virus patient-reported outcomes (HCV-PRO) instrument. Chronic HCV infection and associated treatments negatively affect PROs of function and well-being.

Methods

In a phase 2 trial, HCV-infected patients received direct-acting antivirals (DAAs) for 12 weeks with peg-interferon/ribavirin (peg-IFN/RBV) for 48 weeks, or placebo plus peg-IFN/RBV. The HCV-PRO total score, SF-36 PCS and MCS scores, EQ-5D-3L, and EQ VAS were measured at baseline, week 8, end of DAA treatment (EODT), end of peg-IFN/RBV treatment (EOT), and posttreatment week 24 (SVR₂₄). Convergent validity of the HCV-PRO was assessed by Pearson’s correlation coefficients. Discriminant validity was assessed by analyzing mean HCV-PRO total scores by EQ-5D anxiety/depression and pain/discomfort domain scores (none vs. some) and presence/absence of depression or fatigue adverse events. MID was identified through effect size (ES) and receiver-operating characteristic (ROC) curve analyses (HCV-PRO response vs. SF-36 PCS/MCS and EQ VAS MID thresholds).

Results

In 74 patients (22 % female; 81 % White; 51 % ≥50 years), correlations (0.64–0.96) between HCV-PRO total scores, SF-36 PCS/MCS scores, and EQ VAS scores at all time points supported convergent validity. HCV-PRO total scores were reduced to 10–30 points in patients impaired by depression, pain, or fatigue symptoms. Impact of peg-IFN/RBV regimen on HCV-PRO ES increased over time (EODT ?0.76; EOT ?0.93). ES and ROC curve analyses indicated an MID of ?10 points.

Conclusion

The HCV-PRO was valid and responsive in the population studied. An MID of ?10 points represented a threshold of clinical significance for the HCV-PRO.     

Health-related quality of life in patients with interstitial cystitis/bladder pain syndrome and frequently associated comorbidities

Purpose

To estimate the association of chronic non-urologic conditions [i.e., fibromyalgia (FM), chronic fatigue syndrome (CFS), and irritable bowel syndrome (IBS)] with health-related quality of life (HRQOL) in patients with interstitial cystitis/bladder pain syndrome (IC/BPS).

Methods

A total of 276 women with established diagnoses of IC/BPS completed a telephone interview which included demographics, self-reported medical conditions, the SF-36 health survey, and the interstitial cystitis symptom index (ICSI). Multivariate linear regression analysis was used to identify correlates of SF-36 physical and mental component summary scores.

Results

Mean patient age was 45.1 (SD 15.9) years, and 83 % of the subjects were white. Mean values for the SF-36 Physical Component Score (PCS) and Mental Component Score (MCS) means were 39 (SD 14) and 45 (SD 12), respectively, indicating significant HRQOL reductions. Mean ICSI score was 11.27 (SD = 4.86). FM and IBS were significantly associated with worse SF-36 scores: ?8 points on the PCS (p < 0.001) and ?6 points on the MCS (p < 0.001). CFS and the presence of other pelvic conditions (overactive bladder, vulvodynia, endometriosis) were not significantly associated with SF-36 PCS and MCS scores.

Conclusions

In patients with IC/BPS, the presence of FM, CFS, and IBS has a significant association with HRQOL, equivalent in impact to the bladder symptoms themselves. These results emphasize the importance of a multidisciplinary approach to treating patients with IC/BPS and other conditions.     

Is the Oswestry Disability Index a valid measure of response to sacroiliac joint treatment?

Purpose

Disease-specific measures of the impact of sacroiliac (SI) joint pain on back/pelvis function are not available. The Oswestry Disability Index (ODI) is a validated functional measure for lower back pain, but its responsiveness to SI joint treatment has yet to be established. We sought to assess the validity of ODI to capture disability caused by SI joint pain and the minimum clinically important difference (MCID) after SI joint treatment.

Methods

Patients (n = 155) participating in a prospective clinical trial of minimally invasive SI joint fusion underwent baseline and follow-up assessments using ODI, visual analog scale (VAS) pain assessment, Short Form 36 (SF-36), EuroQoL-5D, and questions (at follow-up only) regarding satisfaction with the SI joint fusion and whether the patient would have the fusion surgery again. All outcomes were compared from baseline to 12 months postsurgery. The health transition item of the SF-36 and the satisfaction scale were used as external anchors to calculate MCID. MCID was estimated for ODI using four calculation methods: (1) minimum detectable change, (2) average ODI change of patients’ subsets, (3) change difference between patients’ subsets, and (4) receiver operating characteristic (ROC) curve.

Results

After SI fusion, patients improved significantly (p < .0001) on all measures: SI joint pain (48.8 points), ODI (23.8 points), EQ-5D (0.29 points), EQ-5D VAS (11.7 points), PCS (8.9 points), and MCS (9.2 points). The improvement in ODI was significantly correlated (p < .0001) with SI joint pain improvement (r = .48) and with the two external anchors: SF-36 health transition item (r = .49) and satisfaction level (r = .34). The MCID values calculated for ODI using the various methods ranged from 3.5 to 19.5 points. The ODI minimum detectable change was 15.5 with the health transition item as the anchor and 13.5 with the satisfaction scale as the anchor.

Conclusions

ODI is a valid measure of change in SI joint health. Hence, researchers and clinicians may rely on ODI scores to measure disability caused by SI pain. We estimated the MCID for ODI to be 13–15 points, which falls within the range of that previously reported for lumbar back pain and indicates that an improvement in disability should be at least 15 % to be beyond random variation.

     

Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials

Background

When comparing active treatments, a non-inferiority (or one-sided equivalence) study design is often used. This design requires the definition of a non-inferiority margin, the threshold value of clinical relevance. In recent studies, a non-inferiority margin of 15 mm has been used for the change in endometriosis-associated pelvic pain (EAPP) on a visual analog scale (VAS). However, this value was derived from other chronic painful conditions and its validation in EAPP was lacking.

Methods

Data were analyzed from two placebo-controlled studies of active treatments in endometriosis, including 281 patients with laparoscopically-confirmed endometriosis and moderate-to-severe EAPP. Patients recorded EAPP on a VAS at baseline and the end of treatment. Patients also assessed their satisfaction with treatment on a modified Clinical Global Impression scale. Changes in VAS score were compared with patients' self-assessments to derive an empirically validated non-inferiority margin. This anchor-based value was compared to a non-inferiority margin derived using the conventional half standard deviation rule for minimal clinically important difference (MCID) in patient-reported outcomes.

Results

Anchor-based and distribution-based MCIDs were-7.8 mm and-8.6 mm, respectively.

Conclusions

An empirically validated non-inferiority margin of 10 mm for EAPP measured on a VAS is appropriate to compare treatments in endometriosis.     

Development of a patient reported outcome scale for fatigue in multiple sclerosis: The Neurological Fatigue Index (NFI-MS)

Background

The impact of Vacuum-assisted breast biopsy (VABB, 11-Gauge) upon Health-related Quality of Life (HRQoL) remains an open field. This study aims to: i) assess short-term (4 days after VABB) responses in terms of HRQoL after VABB, ii) evaluate long-term (18 months after VABB) responses, if any, and iii) examine whether these responses are modified by a variety of possible predictors (anthropometric, sociodemographic, lifestyle habits, breast-related parameters, reproductive history, VABB-related features and complications, seasonality).

Methods

This study included 102 eligible patients undergoing VABB and having benign lesions. A variable number of cores (24-96 cores) has been excised. HRQoL was assessed by EQ-5D and SF-36^® questionnaires: i) in the morning of the VABB procedure day (baseline measurement), ii) four days after VABB (early post-biopsy measurement) and iii) 18 months after VABB (late post-biopsy measurement). Statistical analysis comprised two steps: i. evaluation of differences in EQ-5D/SF-36 dimensions and calculated scores (baseline versus early post-biopsy measurement and baseline versus late post-biopsy measurement) and ii. assessment of predictors through multivariate linear, logistic, ordinal logistic regression, as appropriate.

Results

At baseline patients presented with considerable anxiety (EQ-5D anxiety/depression dimension, EQ-5D TTO/VAS indices, SF-36 Mental Health dimension). At the early post-biopsy measurement women exhibited deterioration in Usual Activities (EQ-5D) and Role Functioning-Physical dimensions. At the late measurement women exhibited pain (EQ-5D pain/discomfort and SF-36 Bodily Pain), deterioration in Physical Functioning (SF-36 PF) and overall SF-36 Physical Component Scale (PCS). Mastalgia, older age and lower income emerged as significant predictors for baseline anxiety, whereas seasonality modified early activities-related responses. Pain seemed idiosyncratic.

Conclusions

The HRQoL profile of patients suggests that VABB exerts effects prior to its performance at a psychological level, immediately after its performance at a functioning-physical level and entails long-term effects associated with pain.     

Results from several population studies show that recommended scoring methods of the SF-36 and the SF-12 may lead to incorrect conclusions and subsequent health decisions

Purpose

To compare the measurement properties of the physical component summary (PCS) and mental component summary (MCS) scores of the SF-36 and SF-12 based on the traditional orthogonal scoring algorithms with the performance of the PCS and MCS scored based on structural equation model coefficients from a correlated model.

Methods

This study used three large-scale representative population studies to compare the measurement properties of the PCS and MCS scores of the SF-36 and SF-12 with the performance of the PCS and MCS scores based on structural equation models producing coefficients from a correlated model. We assessed the relationships of these scores with selected important mental health measures and chronic conditions from three representative Australian population studies that address clinical conditions of high prevalence and health service importance.

Results

Structural equation model scoring methods produced summary scores with higher correlations than the recommended orthogonal methods across a range of disease and health conditions. The problem experienced in using the orthogonal methods is that negative scoring coefficients are applied to negative z-scores for sub-scales, inflating the resulting summary scores. Effect sizes over a half of a standard deviation were common.

Conclusions

If health policy or investment decisions are made based on the results of studies employing the recommended orthogonal scoring methods then the expected outcome of such decisions or investments may not be achieved.     

Impact of diagnosis of diabetes on health-related quality of life among high risk individuals: the Diabetes Prevention Program outcomes study

Purpose

The purpose of this study is to assess if diagnosis of type 2 diabetes affected health-related quality of life (HRQoL) among participants in the Diabetes Prevention Program/Diabetes Prevention Program Outcome Study and changes with treatment or diabetes duration.

Methods

3,210 participants with pre-diabetes were randomized to metformin (MET), intensive lifestyle intervention (ILS), or placebo (PLB). HRQoL was assessed using the SF-36 including: (1) 8 SF-36 subscales; (2) the physical component (PCS) and mental component summary (MCS) scores; and (3) the SF-6D. The sample was categorized by diabetes free versus diagnosed. For diagnosed subgroup, mean scores in the diabetes-free period, at 6 months, 2, 4 and 6 years post-diagnosis, were compared.

Results

PCS and SF-6D scores declined in all participants in all treatment arms (P < .001). MCS scores did not change significantly in any treatment arm regardless of diagnosis. ILS participants reported a greater decrease in PCS scores at 6 months post-diagnosis (P < .001) and a more rapid decline immediately post-diagnosis in SF-6D scores (P = .003) than the MET or PLB arms. ILS participants reported a significant decrease in the social functioning subscale at 6 months (P < .001) and two years (P < .001) post-diagnosis.

Conclusions

Participants reported a decline in measures of overall health state (SF-6D) and overall physical HRQoL, whether or not they were diagnosed with diabetes during the study. There was no change in overall mental HRQoL. Participants in the ILS arm with diabetes reported a more significant decline in some HRQoL measures than those in the MET and PLB arms that developed diabetes.     

Measurement bias of the SF-36 Health Survey in older adults with chronic conditions

Purpose

The objectives of this study were to investigate the psychometric properties of the SF-36 in a sample of older adults with chronic conditions and to test whether measurement bias exists based on the levels of comorbidity.

Methods

Participants included were 979 cognitively intact older adults with comorbidities who were interviewed at their homes. We examined the psychometric properties of the SF-36 and conducted confirmatory factor analysis (CFA) to investigate the assumption of measurement invariance by the levels of comorbidity.

Results

Overall data quality was high and scaling assumptions were generally met with few exceptions. Floor and ceiling effects were present for the role-physical and role-emotional subscales. Using CFA, we found that a three-factor measurement model fits the data well. We identified two violations of measurement invariance. Results showed that participants with high comorbidity level place more emphasis on social functioning (SF) and bodily pain (BP) in relation to physical health-related quality of life (HRQoL) than those with low comorbidity level.

Conclusions

Measurement bias was present for the SF and BP components of the SF-36 physical HRQoL measure. Researchers should be cautious when considering the use of SF-36 in clinical studies among older adults with comorbidities.     

The association of responsiveness in oral and general health-related quality of life with patients’ satisfaction of new complete dentures

Purpose

The objective was to determine the responsiveness properties of the Oral Health Impact Profile (OHIP) short-forms and 36-item Short-Form (SF-36) in complete denture treatment, and further to evaluate the association between patients’ satisfaction and improvements in oral and general health-related quality of life (OHRQoL and HRQoL) after fitting of new, complete dentures.

Methods

Study data were obtained from the ‘Dentures for the Elders through Public Funding’ study conducted in Kaohsiung County. A total of 224 subjects received denture treatments with 6-month follow-up and pre-/post-treatment interviews by questionnaire. The OHIP and SF-36 were used to measure OHRQoL and HRQoL. In addition, specific questions investigating seven aspects of patients’ satisfaction were used to measure the patients’ perceptions of complete denture success. The responsiveness of all outcome measures and their dimensions were assessed by effect size (ES). Multivariable analysis was used to examine the association between patients’ satisfaction and OHIP/SF-36 while adjusting for demographic characteristics.

Results

There were improvements with regard to the ‘physical pain’ (ES = 0.19) and ‘psychological discomfort’ (ES = 0.42) dimensions of the Taiwanese short-form OHIP (OHIP-14T) after new complete denture treatment, but only improvement in the ‘general health’ (ES = 0.17) dimension in the SF-36 measure. Patients satisfied with ‘comfort’ and ‘ease of cleaning’ of their new dentures were significantly associated with the improvement of the OHIP-49 and OHIP-14T.

Conclusions

This study suggests that denture treatments are associated with improvements of OHRQoL, but not in HRQoL. Furthermore, patients’ satisfaction was significantly associated with responsiveness of OHRQoL but less significantly associated with responsiveness of HRQoL.     

Pattern of impact of femoroacetabular impingement upon health-related quality of life: the determinant role of extra-articular factors

Purpose

Despite the interest in surgical treatment of femoroacetabular impingement (FAI), its impact upon health-related quality of life (HRQoL) has not been established. The objectives of this study were twofold: (a) to describe the pattern of impact of FAI on HRQoL and (b) to assess how articular and extra-articular factors influence HRQoL in this group of patients.

Methods

A total of 108 patients [55 females (50.9 %); age 36.0 ± 12.4 years] with intraoperatively confirmed FAI and no evidence of secondary hip osteoarthritis were studied. The pattern of impact on HRQoL was studied using SF-36 V.2? and then contrasted with other medical conditions employing the SF-36 spydergram. The best model explaining the influence of “articular” and “extra-articular” factors over the SF-36 physical and mental component scores (PCS/MCS) was selected using the Akaike information criterion.

Results

The PCS was 53.2 ± 19.2 and MCS was 68.94 ± 17.15. The SF-36 spydergram depicted an impact pattern distinguishable from other conditions. A linear model predicted PCS would increase by 8.9 points in male patients and 3.7 points per point of University of California Los Angeles score (p value <0.01; R2 0.29). For MCS, obesity resulted in a 12.7 point reduction, psychiatric comorbidity reduced it by 11.1; and a combined reduction of 19 points (p value <0.01; R2 0.18). Unexpectedly, the extent of intra-articular disease had no influence on PCS or MCS.

Conclusions

FAI impacts HRQoL with a distinguishable pattern. In our study, the manner in which HRQoL is affected by FAI can be explained only by patients’ characteristics unrelated to the extent of intra-articular disease.

Level of evidence

Prognostic Level IV.     

A comparison of SF-36 summary measures of physical and mental health for women across the life course

Background

Physical and mental component summary scores (PCS and MCS, respectively) are often used to summarise SF-36 quality of life subscales. This paper investigates PCS and MCS across the life course and compares the trajectories obtained from two different methods of calculation.

Methods

The Australian Longitudinal Study on Women’s Health is a population-based study with three cohorts of women and SF-36 surveys taken at multiple time points. Scoring coefficients for each component score were determined using factor analysis with uncorrelated (orthogonal) and correlated (oblique) rotation at the baseline survey, which were then used to compute correlated and uncorrelated PCS and MCS scores at each survey (scaled to have mean of 50 and standard deviation of 10 at baseline).

Results

For both methods, PCS declined progressively across the lifespan, while MCS rose in young and mid-age women to a peak and subsequently declined in later life. Differences were apparent between correlated and uncorrelated scores, most notably for MCS in the older cohort, where correlated MCS reached 54.6 but still less than uncorrelated MCS, with a random effects model indicating 1.63 (95 % confidence intervals 1.58–1.67) units difference; it then declined to a score of 51.2 by the last survey and the difference widened to 3.44 (3.38–3.50) units compared with the uncorrelated MCS.

Conclusions

PCS and MCS have distinct trajectories through life, with differences in results from correlated and uncorrelated component summary scores. The divergence is most notable with MCS, especially for older women, suggesting that correlated MCS and PCS should be used when examining change in health over time in this age group.     

Impact of laparoscopic colorectal segment resection on quality of life in women with deep endometriosis: one year follow-up

Purpose

To evaluate the changes in quality of life (QOL) over a 1-year follow-up period in patients submitted to laparoscopic colorectal resection for the treatment of deep endometriosis.

Methods

A prospective observational cohort study (Canadian Task Force Design Classification II) involving 40 women with intestinal deep endometriosis was conducted between June 2007 and September 2008 at the Department of Obstetrics and Gynecology, Santa Casa Medical School, Sao Paulo, Brazil. Prior to the surgical procedure, all patients received magnetic resonance studies of the pelvis and rectal echoendoscopy, which suggested intestinal involvement of the disease in all cases. The patients received laparoscopic colorectal resections and treatment for other endometriotic lesions. The subjects completed the QOL SF-36 at 3 time points (T0 pre-operatively; T1 6 months post-operatively; and T2 1 year post-operatively).

Results

The physical functioning, role physical, social functioning and role emotional subscales evidenced the most substantial median increases for T0, T1 and T2. The pain, general health, vitality and mental health domains showed slight changes and increases in medians but did not increase to the same extent as the previous group. Significant improvements were observed in all domains of the SF-36 throughout the study period (p < 0.05). Physical health-related QOL domains showed greater improvement than mental health domains. Analyses of age, parity and body mass index as potential factors influencing the impact of surgery on QOL revealed no differences. Therefore, these factors were not used as prognostic indicators for the surgical procedure or for patient follow-up. In addition, we noted that the patients with poorest results on the initial QOL questionnaire showed the greatest improvements at the end point.

Conclusion

The study results showed that laparoscopic colorectal segment resection for endometriosis had a positive impact on QOL in this patient group. The positive effects persisted 1 year after surgery.     

Trajectories and associated factors of quality of life,global outcome,and post-concussion symptoms in the first year following mild traumatic brain injury

Purpose

To investigate the associated factors and change trajectories of quality of life (QoL), global outcome, and post-concussion symptoms (PCS) over the first year following mild traumatic brain injury (mTBI).

Methods

This was a prospective longitudinal study of 100 participants with mTBI from neurosurgical outpatient departments in Chiayi County District Hospitals in Taiwan. The checklist of post-concussion syndromes (CPCS) was used to assess PCS at enrollment and at 1, 3, and 12 months after mTBI; the glasgow outcome scale extended (GOSE), the quality of life after brain injured (QOLIBRI), Chinese version, and the Short Form 36 Health Survey (SF-36), Taiwan version, were used to assess mTBI global outcome and QoL at 1, 3, and 12 months after mTBI.

Results

Latent class growth models (LCGMs) indicated the change trajectories of QOLIBRI, PCS SF-36, MCS SF-36, GOSE, and PCS. Classes of trajectory were associated with age ≥40 years, unemployment at 1 month after injury, and educational level ≤12 years. Univariate analysis revealed that employment status at 1 month post-injury was correlated with the trajectories of QOLIBRI, PCS SF-36, MCS SF-36, and GOSE, but not PCS.

Conclusions

Employment status was the most crucial associated factor for QoL in individuals with mTBI at the 1-year follow-up. Future studies should explore the benefits of employment on QoL of individuals with mTBI.

     

Health-related quality of life with KDQOL-36 and its association with self-efficacy and treatment satisfaction in Korean dialysis patients

Background and objectives

This study was conducted to measure the level of health-related quality of life (HRQOL) and to reveal the association of self-efficacy and treatment satisfaction with it in Korean dialysis patients.

Design, setting, participants, and measurements

The study subjects were 237 patients receiving either hemodialysis (HD) or peritoneal dialysis (PD) from two university hospitals, from February to June in 2010. We investigated HRQOL using the Korean version of Kidney Disease Quality of Life Short Form 36 (KDQOL-36), and self-efficacy and treatment satisfaction by self-administrative questionnaire and their dialysis-related variables by reviewing clinical records. The associations of self-efficacy and treatment satisfaction with HRQOL were assessed using multiple linear regression analysis.

Results

The mean HRQOL results were as follows: Physical component score (PCS) was 39.1 ± 8.5, Mental component score (MCS) 44.6 ± 6.8, symptom/problem list was 67.6 ± 17.1, effects of disease score was 58.5 ± 19.6, and burden of disease score was 41.1 ± 28.4. Between PD and HD patients, we could find significant difference only in the symptom/problem list. After removing confounder’s effects by multivariate analysis, respectively, treatment goal self-efficacy and treatment management self-efficacy were significantly related with all 5 domains, except PCS. Treatment satisfaction was significantly related with PCS, MCS, and effects of kidney disease.

Conclusions

Patients’ self-efficacy and treatment satisfaction could influence their HRQOL. Regular and systematic monitoring using KDQOL-36 and interventions to increase self-efficacy and treatment satisfaction should be considered in dialysis care in Korea.     

Quality of life and neck pain in nurses

Objectives

To investigate the association between neck pain and psychological stress in nurses.

Material and Methods

Nurses from the Avon Orthopaedic Centre completed 2 questionnaires: the Short Form-36 (SF-36) and 1 exploring neck pain and associated psychological stress.

Results

Thirty four nurses entered the study (68% response). Twelve (35.3%) had current neck pain, 13 (38.2%) reported neck pain within the past year and 9 (26.5%) had no neck pain. Subjects with current neck pain had significantly lower mental health (47.1 vs. 70.4; p = 0.002), physical health (60.8 vs. 76.8; p = 0.010) and overall SF-36 scores (56.8 vs. 74.9; p = 0.003). Five (41.7%) subjects with current neck pain and 5 (38.5%) subjects with neck pain in the previous year attributed it to psychological stress.

Conclusions

Over 1/3 of nurses have symptomatic neck pain and significantly lower mental and physical health scores. Managing psychological stress may reduce neck pain, leading to improved quality of life for nurses, financial benefits for the NHS, and improved patient care.     

Changing values, changing outcomes: the influence of reprioritization response shift on outcome assessment after spine surgery

Background

When patients experience a substantial health state change, they may undergo changes in the underlying meaning of their self-report to standardized outcome measures. These response shifts can reflect changes in the patient’s internal standards, values or conceptualization of quality of life. We investigated the presence of changing values (reprioritization response shift) in a longitudinal cohort of spine surgery patients.

Methods

Spinal decompression surgery patients (mean age 52 years; 39 % female, 36 % working) provided visual analogue scale (VAS) back and leg pain items, the Short-Form-36 (SF-36v1), and the Oswestry Disability Index (ODI) data pre- and post-surgery (n _pre = 169; n _6weeks = 102; n _3months = 106; n _6months = 68). Improved and No-Effect patient groups were compared using the VAS minimally important difference (±15 points) as a cutoff. Reprioritization response shift detection was based on change in the relative importance of the SF-36 domains for group discrimination pre- and post-surgery.

Results

The Improved group evidenced significant post-surgery differences from the No-Effect group on bodily pain, general health, physical functioning, social functioning, vitality, and the ODI. The relative importance analysis showed a differential effect with bodily pain (p < 0.01) and physical functioning (p < 0.05) becoming more important, and role physical (p < 0.01) becoming less important post-surgery in distinguishing the Improved group as compared to the No-Effect group. The Improved patients also evidenced stronger associations between bodily pain and physical functioning, vitality and general health (p < 0.05). The No-Effect group evidenced increased inter-correlations of bodily pain with social functioning, mental health, and general health (p < 0.05).

Conclusions

Patients who report clinically significant change in leg and back pain post-surgery using VAS pain scores are also distinguished by increased importance of bodily pain and physical functioning, and decreased importance of role physical. Bodily pain is primarily reflective of physical item response post-surgery among Improved patients, but reflects physical, social, and emotional item response among No-Effect patients. These changes in values may reflect a “moving goal post” in outcome assessment that complicates the interpretation of mean differences over time on standard spine outcome measures.     

Type D, anxiety and depression in association with quality of life in patients with Parkinson’s disease and patients with multiple sclerosis

Purpose

The present study examines the role of Type D personality, anxiety and depression in quality of life (QoL) in patients with two chronic neurological diseases—Parkinson’s disease (PD) and multiple sclerosis (MS).

Methods

This cross-sectional study included 142 PD patients (73 % males; mean age 67.6 ± 9.2 years) and 198 patients with MS (32.3 % males; 38.4 ± 10.8 years). Multiple regression analyses were used to analyze the association of UDPRS (PD patients) or EDSS (MS patients), Type D personality (DS-14) and anxiety and depression (HADS) with the physical (PCS) and mental summary (MCS) of QoL, as measured by the SF-36.

Results

In PD patients, Type D was significantly associated with MCS only; in MS patients, Type D was significantly associated with both dimensions—MCS and PCS. After adding anxiety and depression, the importance of Type D for the QoL model dramatically decreased. Anxiety and depression were strongly associated with lower scores in MCS and PCS in both PD and MS patients.

Conclusions

The actual mood of PD and MS patients—the level of anxiety or depression—might have a greater impact on patients’ QoL than their personality. Further longitudinal research should focus on how the pathway consisting of personality traits, anxiety and depression, and QoL might be constructed.     

Spanish validation of the "Kidney Transplant Questionnaire": a useful instrument for assessing health related quality of life in kidney transplant patients

Background

There is a growing interest in the evaluation of Health Related Quality of Life (HRQoL) among patients undergoing Renal Replacement Therapy. In Spain, no specific questionnaire exists for kidney transplant patients. Here we present the Spanish validation of the first specific HRQoL assessment tool: the kidney transplant questionnaire (KTQ).

Methods

Prospective study of 31 patients on transplant waiting list who received the first kidney. Patients were evaluated before transplant and after 1, 3, 6 and 12 months, using the KTQ and the SF-36 Health Survey. Feasibility, validity, reliability, and sensibility to change were evaluated.

Results

Mean time of administration of the KTQ was 12 minutes. Correlation coefficients among KTQ dimensions range between 0.32 and 0.72. Correlation coefficients of KTQ dimensions with SF-36 PCS were low (r<0.4), and with SF-36 MCS were moderate-high (r>0.4) except for Physical Symptom dimension (r = 0.33). Cronbach's Alpha was satisfactory for all KTQ dimensions (Physical Symptoms = 0.80; Fatigue = 0.93; Uncertainty/Fear = 0.81; Emotional= 0.90) except Appearance (0.69). Intraclass correlation coefficients ranged between 0.63 and 0.85, similar to those of the original KTQ version.

Conclusions

Results of validation study show that feasibility, validity, reliability and sensibility to change of the Spanish version of the KTQ are similar to those of the original version.