Women undergoing radical cystectomy (RC) and urinary diversion for bladder cancer experience substantial limitations in health-related quality of life (HRQOL). However, the level of discomfort caused by different urinary diversion has been never evaluated in long term survivors. The aim of this multicenter study is to evaluate differences in HRQOL among recurrence-free women undergoing cutaneous ureterostomy (CUS), Bricker's ileal conduit (BK-IC) and Orthotopic neobladder VIP (ONB-VIP) in disease-free females treated with radical cystectomy (RC), with long-term follow up (mean 60.1 months; range 36-122 months).
Materials and methods
All consecutively treated female patients from two urological institutions who underwent RC and urinary diversion from January 2000 to December 2008, with no evidence of tumor recurrence at a minimum follow up of 36 months, were included. Patients received the European Organisation for Research and Treatment of Cancer (EORTC) generic (QLQ-C30) and bladder cancer-specific instruments (QLQ-BLM30) and the Functional Assessment of Cancer Therapy for Bladder Cancer (FACT-BL). Clinical data and questionnaire results were analyzed in order to evaluate the HRQOL differences among diversion groups.
We identified 37 females (median age: 68, range 45–82 years), including 12 status-post CUS, 16 who underwent BK-IC, and 9 who underwent ONB-VIP. Most were healthy (24/37 with no comorbidities, 4/37 Charlson 1-2, 9/37 Charlson 3 or greater – we didn’t considered bladder cancer in Charlson evaluation because bladder cancer was the main inclusion criteria). Women undergoing CUS endorsed worse FACT-BL scores compared with BK-IC and ONB-VIP patients, worse HRQOL regarding physical and emotional well-being (p=0.008 and p=0.02, respectively), and a trend toward worse EORTC QLQ-C30 scores for appetite loss and fatigue (p=0.05 for both).
In our study long-term disease-free females treated with CUS endorsed worse HRQOL compared with women who underwent BK-IC or ONB-VIP, mostly due to worse physical and emotional perception of their body image.
Urinary diversion; Orthotopic urinary reservoirs; Bladder cancer; Quality of life
Selection of an appropriate patient-reported outcome (PRO) instrument for a clinical trial requires knowledge of the instrument’s responsiveness to detecting treatment effects. The purpose of this study was to examine the responsiveness of two health-related quality of life (HRQL) instruments used in clinical trials involving HIV-infected adults: the HIV-targeted Medical Outcomes Study HIV Health Survey (MOS-HIV), and a generic measure, the EuroQol-5D (EQ-5D).
A systematic review identified clinical trials using the MOS-HIV or EQ-5D to assess outcomes for HIV-infected adults. Data abstracted from each study included study type, treatment regimen(s), PRO results, and effect size (either reported or calculated). Effect size was calculated as the difference between baseline and follow-up mean scores divided by the baseline standard deviation. Magnitude was categorized as small (d=0.20), medium (d=0.50), and large (d=0.80).
Between 2005 and 2010, the MOS-HIV was administered in 12 trials. Significant differences were observed between groups and over time in physical health summary (PHS) and mental health summary (MHS) scores (P<0.05) in subjects switching therapy after experiencing Grade-2 adverse events. Effect sizes were medium (0.55 and 0.49 for PHS and MHS, respectively) among treatment-naïve adults beginning therapy (two studies), but negligible among treatment-experienced adults (0.04 and 0.13 for PHS and MHS, respectively; three studies). The EQ-5D was used in five trials between 2001 and 2010. It was responsive to occurrences of adverse events and opportunistic infections, with small-to-medium effect sizes (range 0.30–0.50) in each of its five dimensions.
A systematic review of PRO study results showed both the MOS-HIV and EQ-5D were responsive to changes between groups and/or over time in treatment-naïve HIV-infected patients. These instruments may be used either individually or together in clinical trials to measure changes in HRQL.
HIV; Patient-reported outcome (PRO); MOS-HIV; EQ-5D; NNRTI
Antibiotics overuse is a global public health issue influenced by several factors, of which some are parent-related psychosocial factors that can only be measured using valid and reliable psychosocial measurement instruments. The PAPA scale was developed to measure these factors and the content validity of this instrument was assessed.
This study further validated the recently developed instrument in terms of (1) face validity and (2) construct validity including: deciding the number and nature of factors, and item selection.
Questionnaires were self-administered to parents of children between the ages of 0 and 12 years old. Parents were conveniently recruited from schools’ parental meetings in the Eastern Province, Saudi Arabia. Face validity was assessed with regards to questionnaire clarity and unambiguity. Construct validity and item selection processes were conducted using Exploratory factor analysis.
Parallel analysis and Exploratory factor analysis using principal axis factoring produced six factors in the developed instrument: knowledge and beliefs, behaviours, sources of information, adherence, awareness about antibiotics resistance, and parents’ perception regarding doctors’ prescribing behaviours. Reliability was assessed (Cronbach’s alpha = 0.78) which demonstrates the instrument as being reliable.
The ‘factors’ produced in this study coincide with the constructs contextually identified in the development phase of other instruments used to study antibiotic use. However, no other study considering perceptions of antibiotic use had gone beyond content validation of such instruments. This study is the first to constructively validate the factors underlying perceptions regarding antibiotic use in any population and in parents in particular.
Antibiotics overuse; Psychosocial; Measurement instrument; Reliability; Validity; Exploratory factor analysis; Saudi Arabia
Anxiety disorders are prevalent and associated with poor prognosis in patients with coronary artery disease (CAD). However, studies examining screening of anxiety disorders in CAD patients are lacking. In the present study we evaluated the prevalence of anxiety disorders in patients with CAD and diagnostic utility of self-rating scales for screening of anxiety disorders.
Five-hundred and twenty-three CAD patients not receiving psychotropic treatments at initiation of rehabilitation program completed self-rating scales (Hospital Anxiety and Depression Scale or HADS; Spielberger State-Anxiety Inventory or SSAI; and Spielberger Trait-Anxiety Inventory or STAI) and were interviewed for generalized anxiety disorder (GAD), social phobia, panic disorder and agoraphobia (Mini-International Neuropsychiatric Interview or MINI).
Thirty-eight (7%) patients were diagnosed with anxiety disorder(s), including GAD (5%), social phobia (2%), agoraphobia (1%) and panic disorder (1%). Areas under the ROC curve of the HADS Anxiety subscale (HADS-A), STAI and SSAI for screening of any anxiety disorder were .81, .80 and .72, respectively. Optimal cut-off values for screening of any anxiety disorders were ≥8 for the HADS-A (sensitivity = 82%; specificity = 76%; and positive predictive value (PPV) = 21%); ≥45 for the STAI (sensitivity = 89%; specificity = 56%; and PPV = 14%); and ≥40 for the SSAI (sensitivity = 84%; specificity = 55%; PPV = 13%). In a subgroup of patients (n = 340) scoring below the optimal major depressive disorder screening cut-off value of HADS-Depression subscale (score <5), the HADS-A, STAI and SSAI had moderate-high sensitivity (range from 69% to 89%) and low PPVs (≤22%) for GAD and any anxiety disorders.
Anxiety disorders are prevalent in CAD patients but can be reliably identified using self-rating scales. Anxiety self-rating scales had comparable sensitivities but the HADS-A had greater specificity and PPV when compared to the STAI and SSAI for screening of anxiety disorders. However, false positive rates were high, suggesting that patients with positive screening results should undergo psychiatric interview prior to initiating treatment for anxiety disorders and that routine use of anxiety self-rating scales for screening purposes can increase healthcare costs. Anxiety screening has incremental value to depression screening for identifying anxiety disorders.
Coronary artery disease; Anxiety; Screening; Sensitivity; Specificity
To map health outcome related variables from a national register, not part of any validated instrument, with EQ-5D weights among stroke patients.
We used two cross-sectional data sets including patient characteristics, outcome variables and EQ-5D weights from the national Swedish stroke register. Three regression techniques were used on the estimation set (n = 272): ordinary least squares (OLS), Tobit, and censored least absolute deviation (CLAD). The regression coefficients for “dressing“, “toileting“, “mobility”, “mood”, “general health” and “proxy-responders” were applied to the validation set (n = 272), and the performance was analysed with mean absolute error (MAE) and mean square error (MSE).
The number of statistically significant coefficients varied by model, but all models generated consistent coefficients in terms of sign. Mean utility was underestimated in all models (least in OLS) and with lower variation (least in OLS) compared to the observed. The maximum attainable EQ-5D weight ranged from 0.90 (OLS) to 1.00 (Tobit and CLAD). Health states with utility weights <0.5 had greater errors than those with weights ≥0.5 (P < 0.01).
This study indicates that it is possible to map non-validated health outcome measures from a stroke register into preference-based utilities to study the development of stroke care over time, and to compare with other conditions in terms of utility.
Mapping; Quality of life; Stroke; Sweden; Transfer to utility; Utility
The aim of this study was to examine the psychometric properties of the Fatigue Severity Scale (FSS) to verify whether this instrument is a valid tool to measure fatigue in obese patients, and to examine the prevalence of fatigue in obese patients.
Before and after a three-week residential multidisciplinary integrated weight reduction program, 220 patients were asked to fill in the questionnaires: FSS, Profile of Mood States (Fatigue-Inertia subscale, POMS-Fatigue, and Vigor-Activity subscale, POMS-Vigor), and the Obesity-Related Well-Being (ORWELL-97). A subsample of 50 patients completed the questionnaire within two days.
The prevalence of fatigue using a cut-off value of 4 for the FSS score was 59%. Correlations were found between FSS and POMS-Fatigue and -Vigor scores (r = 0.58 and 0.53, respectively). A relation was also found between FSS and ORWELL97 (r = 0.52, 0.42 to 0.61). From the factorial analysis only 1 factor was extracted explaining 63% of variance, with factor loading values ranging from 0.71 (item 7) to 0.87 (item 6). Intraclass Correlation Coefficient was 0.89 (0.82 to 0.94), while the agreement as measured using the Standard Error of Measurement was 0.43 (0.36 to 0.54) corresponding to 13% (11 to 17%). Cronbach’s alpha values ranged from 0.94 to 0.93. The internal responsiveness of FSS was comparable to the ORWELL97 (Standardized Response Mean = 0.50 and 0.44, respectively).
Fatigue is an important and frequent symptom in obese patients and therefore should be routinely assessed in both research and clinical practice. This can be achieved using the FSS, which is a short, simple, valid and reliable tool for assessing and quantifying fatigue in obese patients.
Obesity; Symptoms; Questionnaires; Psychometrics
Background and objectives
Nephrotic syndrome (NS) represents a common disease in pediatric nephrology typified by a relapsing and remitting course and characterized by the presence of edema that can significantly affect the health-related quality of life in children and adolescents. The PROMIS pediatric measures were constructed to be publically available, efficient, precise, and valid across a variety of diseases to assess patient reports of symptoms and quality of life. This study was designed to evaluate the ability of children and adolescents with NS to complete the PROMIS assessment via computer and to initiate validity assessments of the short forms and full item banks in pediatric NS. Successful measurement of patient reported outcomes will contribute to our understanding of the impact of NS on children and adolescents.
This cross-sectional study included 151 children and adolescents 8-17 years old with NS from 16 participating institutions in North America. The children completed the PROMIS pediatric depression, anxiety, social-peer relationships, pain interference, fatigue, mobility and upper extremity functioning measures using a web-based interface. Responses were compared between patients experiencing active NS (n = 53) defined by the presence of edema and patients with inactive NS (n = 96) defined by the absence of edema.
All 151 children and adolescents were successfully able to complete the PROMIS assessment via computer. As hypothesized, the children and adolescents with active NS were significantly different on 4 self-reported measures (anxiety, pain interference, fatigue, and mobility). Depression, peer relationships, and upper extremity functioning were not different between children with active vs. inactive NS. Multivariate analysis showed that the PROMIS instruments remained sensitive to NS disease activity after adjusting for demographic characteristics.
Children and adolescents with NS were able to successfully complete the PROMIS instrument using a web-based interface. The computer based pediatric PROMIS measurement effectively discriminated between children and adolescents with active and inactive NS. The domain scores found in this study are consistent with previous reports investigating the health-related quality of life in children and adolescents with NS. This study establishes known-group validity and feasibility for PROMIS pediatric measures in children and adolescents with NS.
Patient reported outcomes; Quality of life; Nephrotic syndrome; Pediatrics
Childhood obesity is a growing health concern known to adversely affect quality of life in children and adolescents. The Patient Reported Outcomes Measurement Information System (PROMIS) pediatric measures were developed to capture child self-reports across a variety of health conditions experienced by children and adolescents. The purpose of this study is to begin the process of validation of the PROMIS pediatric measures in children and adolescents affected by obesity.
The pediatric PROMIS instruments were administered to 138 children and adolescents in a cross-sectional study of patient reported outcomes in children aged 8–17 years with age-adjusted body mass index (BMI) greater than the 85th percentile in a design to establish known-group validity. The children completed the depressive symptoms, anxiety, anger, peer relationships, pain interference, fatigue, upper extremity, and mobility PROMIS domains utilizing a computer interface. PROMIS domains and individual items were administered in random order and included a total of 95 items. Patient responses were compared between patients with BMI 85 to < 99th percentile versus ≥ 99th percentile.
136 participants were recruited and had all necessary clinical data for analysis. Of the 136 participants, 5% ended the survey early resulting in missing domain scores at the end of survey administration. In multivariate analysis, patients with BMI ≥ 99th percentile had worse scores for depressive symptoms, anger, fatigue, and mobility (p < 0.05). Parent-reported exercise was associated with better scores for depressive symptoms, anxiety, and fatigue (p < 0.05).
Children and adolescents ranging from overweight to severely obese can complete multiple PROMIS pediatric measures using a computer interface in the outpatient setting. In the 5% with missing domain scores, the missing scores were consistently found in the domains administered last, suggesting the length of the assessment is important. The differences in domain scores found in this study are consistent with previous reports investigating the quality of life in children and adolescents with obesity. We show that the PROMIS instrument represents a feasible and potentially valuable instrument for the future study of the effect of pediatric obesity on quality of life.
Quality of life; Obesity; Patient Reported Outcomes Measurement Information System (PROMIS); Child; Depression
The objectives for this study were to assess Oral Health Related Quality of Life (OHRQoL) in young people aged 15–25 who sought orthodontic treatment, and to measure the association between orthodontic treatment need (using the IOTN), sex, age and education level, and oral health related quality of life (OHRQoL).
Survey of a consecutive series of 323 young adults aged 15 to 25 years, attending orthodontic clinics at the Faculty of Dentistry, Universiti Teknologi MARA. Participants completed the Oral Health Impact Profile-14 (OHIP-14) and had a clinical examination including the Index of Orthodontic Treatment Need- Dental Health Component (IOTN-DHC). Data analyses included descriptive statistics, One-way ANOVA and bivariate and multivariate regression models.
The mean overall score (± SD) for OHIP-14 in young people aged 15–25 was 22.6 ± 12.5. The psychological discomfort domain was the domain where highest impact was recorded with a mean (± SD) of 4.0 ± 1.9. The regression analyses showed a significant association of IOTN-DHC with overall OHIP-14 score (p < 0.05). Although females reported a slightly higher impact than males, this was not significant in both bivariate and multivariate analyses. Age group had a significant negative association with overall OHIP-14 score (p < 0.05). The 15–18 year old group showed the highest impact on their quality of life due to malocclusion. Participants with a university education report a significantly higher impact on OHRQoL as compared to participants with only secondary education.
Malocclusion has a significant negative impact on OHRQoL and its domains. This is greatest for the psychological discomfort domain. Younger people and those with a university education report higher levels of impact. There was no reported difference in impact between male and females.
Oral health related quality of life; Malocclusion; Treatment need; OHIP
To investigate health-related quality of life (HRQOL) in patients affected by early systemic sclerosis (eSSc) and to compare it with that of patients with undifferentiated connective tissue disease (UCTD).
At baseline, 31 eSSc and 35 UCTD patients underwent clinical evaluation, laboratory investigations, nailfold videocapillaroscopy, echocardiography, and lung function tests. All patients and 40 controls, matched for sex and age completed the Short Form-36 (SF-36) questionnaire and the Health Assessment Questionnaire Disability Index (HAQ-DI).
SF-36 scores were significantly lower in eSSc and UCTD patients than in healthy controls as regards the following domains: physical component score (PCS), mental component score (MCS), physical functioning, role-physical, bodily pain, general health and mental health. PCS was negatively correlated to the HAQ-DI (rho −0.59; p = 0.0004) and ESR >20 mm/h (rho −0.58; p = 0.0006) in eSSc patients. No statistically significant correlation was found between PCS, MCS and HAQ-DI in UCTD patients. Age, sex, disease duration, history of arthritis, low levels of either C3 or C4, a low DLCO (carbon monoxide lung diffusion) and inversion of the E/A ratio were not correlated to PCS and MCS in either eSSc or UCTD patients.
Many eSSc or UCTD patients perceive they have an impaired quality of life in both physical and mental domains. This condition has to be taken into account by the clinicians involved in the care of these patients.
Quality of life; Systemic sclerosis; Undifferentiated connective tissue disease
Compared to existing literature on childhood attention deficit hyperactivity disorder (ADHD), little published adult data are available, particularly outside of the United States. Using General Practitioner (GP) questionnaires from the United Kingdom, this study aimed to examine a number of issues related to ADHD in adults, across three cohorts of patients, adults who received ADHD drug treatment in childhood/adolescence but stopped prior to adulthood; adults who received ADHD drug treatment in childhood/adolescence and continued treatment into adulthood and adults who started ADHD drug treatment in adulthood.
Patients with a diagnosis of ADHD and prescribed methylphenidate, dexamfetamine or atomoxetine were identified using data from The Health Improvement Network (THIN). Dates when these drugs started and stopped were used to classify patients into the three cohorts. From each cohort, 50 patients were randomly selected and questionnaires were sent via THIN to their GPs.
GPs returned completed questionnaires to THIN who forwarded anonymised copies to the researchers. Datasets were analysed using descriptive statistics.
Overall response rate was 89% (133/150). GPs stated that in 19 cases, the patient did not meet the criteria of that group; the number of valid questionnaires returned was 114 (76%). The following broad trends were observed: 1) GPs were not aware of the reason for treatment cessation in 43% of cases, 2) patient choice was the most common reason for discontinuation (56%), 3) 7% of patients who stopped pharmacological treatment subsequently reported experiencing ADHD symptoms, 4) 58% of patients who started pharmacological treatment for ADHD in adulthood received pharmacological treatment for other mental health conditions prior to the ADHD being diagnosed.
This study presents some key findings relating to ADHD; GPs were often not aware of the reason for patients stopping ADHD treatment in childhood or adolescence. Patient choice was identified as the most common reason for treatment cessation. For patients who started pharmacological treatment in adulthood, many patients received pharmacological treatment for comorbidities before a diagnosis of ADHD was made.
Attention deficit hyperactivity disorder; Adult; Stimulant; Primary care; General practitioner
Neurofibromatosis type 1 (NF1) is a common autosomal dominant genetic disorder with significant impact on health-related quality of life (HRQOL). Research in understanding the pathogenetic mechanisms of neurofibroma development has led to the use of new clinical trials for the treatment of NF1. One of the most important outcomes of a trial is improvement in quality of life, however, no condition specific HRQOL instrument for NF1 exists. The objective of this study was to develop an NF1 HRQOL instrument as a module of PedsQL™ and to test for its initial feasibility, internal consistency reliability and validity in adults with NF1.
The NF1 specific HRQOL instrument was developed using a standard method of PedsQL™ module development – literature review, focus group/semi-structured interviews, cognitive interviews and experts’ review of initial draft, pilot testing and field testing. Field testing involved 134 adults with NF1. Feasibility was measured by the percentage of missing responses, internal consistency reliability was measured with Cronbach’s alpha and validity was measured by the known-groups method.
Feasibility, measured by the percentage of missing responses was 4.8% for all subscales on the adult version of the NF1-specific instrument. Internal consistency reliability for the Total Score (alpha =0.97) and subscale reliabilities ranging from 0.72 to 0.96 were acceptable for group comparisons. The PedsQL™ NF1 module distinguished between NF1 adults with excellent to very good, good, and fair to poor health status.
The results demonstrate the initial feasibility, reliability and validity of the PedsQL™ NF1 module in adult patients. The PedsQL™ NF1 Module can be used to understand the multidimensional nature of NF1 on the HRQOL patients with this disorder.
PedsQL™; Neurofibromatosis type 1 (NF1); Health-related quality of life; Patient reported outcomes
Musculoskeletal disorders are major causes of morbidity in the world, and these conditions have a strong negative influence in terms of health-related quality of life. The purpose of this study was to evaluate the effect of an 8-week multimodal physical therapy program on general health state and health-related quality of life in patients with chronic musculoskeletal disorders.
There were 244 participants in this prospective cohort analysis with 8-week follow-up. The primary outcome was general health state (physical and mental components), determined with the Short Form-12 Health Survey (SF-12). The secondary outcome was health related quality of life, determined with the EuroQoL-5D and VAS. The intervention was evaluated by comparing pre- and post-outcome measurements. T-tests were performed for paired data.
Differences were statistically significant for physical health state: +1.68 (p < 0.05) (baseline: 42.38); mental health state: +3.15 (p < 0.001) (baseline: 46.57); and health related quality of life: +0.18 (EuroQoL 5D) (baseline: 46.57) and +7.22 (EuroQoL_VAS) (p < 0.001) (baseline: 60.81). Intervention resulted in clinically relevant changes in terms of percentage improvement from baseline scores.
Eight weeks of a Multimodal Physical Therapy Program seemed to moderately enhance the general health state and HRQoL of patients with chronic musculoskeletal diseases. This kind of therapeutic exercise can be recommended to patients with chronic low back pain, chronic neck pain and osteoarthritis, at least in the short term.
Chronic musculoskeletal disorders; Multimodal physiotherapy; Aquatic exercise; HRQoL
Although the Chinese government put a lot of effort into promoting the community patient’s life satisfaction, there still lacked the holistic and systematic approaches to promote the community patient’s life satisfaction in various regions of China. On the basis of the literature, it was found that both the community patient’s assessment of community medical service and trust in community health delivery system were important considerations when the community patient comprehensively evaluated community medical service to generate life satisfaction. So this study was set up to test whether and to what extent the community patient’s assessments of various major aspects of community medical service/various major aspects of the community patient’s trust in community health delivery system influenced life satisfaction in whole China/in various regions of China.
In order to explore the situation of China’s community health delivery system before 2009 and provide a reference for China’s community health delivery system reform, the data that could comprehensively and accurately reflect the community patient’s life satisfaction, assessment of community medical service, and trust in community health delivery system in various regions of China was needed, so this study collaborated with the National Bureau of Statistics of China to carry out a large-scale 2008 national community resident household survey (N = 3,306) for the first time in China. And the specified ordered probit models were established to analyze the dataset from this household survey.
Among major aspects of community medical service, the medical cost (particularly in developed regions), the doctor-patient communication (particularly in developed regions), the medical facility and hospital environment (particularly in developed regions), and the medical treatment process (particularly in underdeveloped regions) were all key considerations (p<0.05 for t statistics) in generating the community patient’s life satisfaction. Among major aspects of the community patient’s trust in community health delivery system, trust in doctor (particularly in underdeveloped regions), trust in prescription (particularly in underdeveloped regions), and trust in recommended medical examination (particularly in underdeveloped regions) were all important considerations (p<0.10 for t statistics) in generating the community patient’s life satisfaction.
The reduction of medical cost (particularly in developed regions), the improvement of doctor-patient communication (particularly in developed regions), the promotion of medical facility and hospital environment (particularly in developed regions), the improvement of medical treatment process (particularly in underdeveloped regions), the promotion of trust in doctor (particularly in underdeveloped regions), the promotion of trust in prescription (particularly in underdeveloped regions), and the promotion of trust in recommended medical examination (particularly in underdeveloped regions) could help promote the community patient’s life satisfaction.
Community health center; Community patient; Life satisfaction; Assessment of community medical service; Trust in community health delivery system; China
There is little robust evidence relating to changes in health related quality of life (HRQL) in morbidly obese patients following a multidisciplinary non-surgical weight loss program or laparoscopic Roux-en-Y Gastric Bypass (RYGB). The aim of the present study was to describe and compare changes in five dimensions of HRQL in morbidly obese subjects. In addition, we wanted to assess the clinical relevance of the changes in HRQL between and within these two groups after one year. We hypothesized that RYGB would be associated with larger improvements in HRQL than a part residential intensive lifestyle-intervention program (ILI) with morbidly obese subjects.
A total of 139 morbidly obese patients chose treatment with RYGB (n=76) or ILI (n=63). The ILI comprised four stays (seven weeks) at a specialized rehabilitation center over one year. The daily schedule was divided between physical activity, psychosocially-oriented interventions, and motivational approaches. No special diet or weight-loss drugs were prescribed. The participants completed three HRQL-questionnaires before treatment and 1 year thereafter. Both linear regression and ANCOVA were used to analyze differences between weight loss and treatment for five dimensions of HRQL (physical, mental, emotional, symptoms and symptom distress) controlling for baseline HRQL, age, age of onset of obesity, BMI, and physical activity. Clinical relevance was assessed by effect size (ES) where ES<.49 was considered small, between .50-.79 as moderate, and ES>.80 as large.
The adjusted between group mean difference (95% CI) was 8.6 (4.6,12.6) points (ES=.83) for the physical dimension, 5.4 (1.5–9.3) points (ES=.50) for the mental dimension, 25.2 (15.0–35.4) points (ES=1.06) for the emotional dimension, 8.7 (1.8–15.4) points (ES=.37) for the measured symptom distress, and 2.5 for (.6,4.5) fewer symptoms (ES=.56), all in favor of RYGB. Within-group changes in HRQOL in the RYGB group were large for all dimensions of HRQL. Within the ILI group, changes in the emotional dimension, symptom reduction and symptom distress were moderate. Linear regression analyses of weight loss on HRQL change showed a standardized beta-coefficient of –.430 (p<.001) on the physical dimension, –.288 (p=.004) on the mental dimension, –.432 (p<.001) on the emotional dimension, .287 (p=.008) on number of symptoms, and .274 (p=.009) on reduction of symptom pressure.
Morbidly obese participants undergoing RYGB and ILI had improved HRQL after 1 year. The weaker response of ILI on HRQL, compared to RYGB, may be explained by the difference in weight loss following the two treatments.
Clinical Trials.gov number NCT00273104
Quality of life; Bariatric surgery; Lifestyle modification
Most of the instruments available to measure the oral health-related quality of life (OHRQoL) in paediatric populations focus on older children, whereas parental reports are used for very young children. The scale of oral health outcomes for 5-year-old children (SOHO-5) assesses the OHRQoL of very young children through self-reports and parental proxy reports. We aimed to cross-culturally adapt the SOHO-5 to the Brazilian Portuguese language and to assess its reliability and validity.
We tested the quality of the cross-cultural adaptation in 2 pilot studies with 40 children aged 5–6 years and their parents. The measurement was tested for reliability and validity on 193 children that attended the paediatric dental screening program at the University of São Paulo. The children were also clinically examined for dental caries. The internal consistency was demonstrated by a Cronbach's alpha coefficient of 0.90 for the children’s self-reports and 0.77 for the parental proxy reports. The test-retest reliability results, which were based on repeated administrations on 159 children, were excellent; the intraclass correlation coefficient was 0.98 for parental and 0.92 for child reports. In general, the construct validity was satisfactory and demonstrated consistent and strong associations between the SOHO-5 and different subjective global ratings of oral health, perceived dental treatment need and overall well-being in both the parental and children’s versions (p < 0.001). The SOHO-5 was also able to clearly discriminate between children with and without a history of dental caries (mean scores: 5.8 and 1.1, respectively; p < 0.001).
The present study demonstrated that the SOHO-5 exhibits satisfactory psychometric properties and is applicable to 5- to 6-year-old children in Brazil.
Oral health; Quality of life; Preschool children; Parents; Validation
Our retrospective follow-up study aimed to explore the degree of overall mental distress in a cohort of solid-organ transplantation (SOT) recipients after liver, heart or lung transplantation. Furthermore, we investigated how overall mental distress is linked to health-related quality of life.
123 SOT patients treated during the study period were enrolled in this investigation at a mean of 24.6 months (SD=11.6) after transplantation. Before transplantation, the Transplant Evaluation Rating Scale (TERS) was used to classify the level of adjustment in psychosocial functioning among transplantation candidates. After transplantation, recipients completed a research battery, which included the SCL-90-R, and the SF-36.
39 (31.7%) transplantation recipients had clinically significant overall mental distress as measured on the Global Severity Index of the SCL-90-R. Obsessive-compulsive symptoms (92.3%), somatization symptoms (87.2%), anxiety symptoms (84.6%), depression symptoms (82.1%) and phobic anxiety symptoms (69.2%) were a frequent finding.
Transplantation recipients with overall mental distress had significant lower levels of adjustment in psychosocial functioning before transaplantation than those without overall mental distress as measured in the TERS. Transplantation-related overall mental distress symptomatology was associated with maximal decrements in health-related quality of life.
Transplantation recipients may face major transplantation- and treatment-related overall mental distress and impairments to their health-related quality of life. Further, overall mental distress is a high-risk factor in intensifying impairments to patients’ overall quality of life.
Solid-organ transplantation; Overall mental distress; Health-related quality of life
The original valuation exercise which formed the basis of the UK EQ-5D time trade-off social tariff of health states, employed a sampling scheme involving 43 health states. Neither that study, nor other published international valuations studies have used explicit quantifiable criteria to justify the choice of sampled states. New criteria are proposed and methods described to aid researchers in designing improved sampling schemes for future EQ-5D sampling exercises.
Four such criteria are described, and applied to assess the merits of four sampling schemes previously reported, using three large observational databases to quantify relative performance. An alternative sampling design conforming to these criteria is described, which aims to generate improved performance.
Previous published approaches are shown to perform poorly against the measured criteria. The alternative sampling design is demonstrated to provide superior performance on all measures.
Future valuation exercises using sampled health states based on this approach may be expected to offer benefits in terms of greater precision, avoidance of bias in favour of less severe states, and a higher proportion of research observations valued directly rather than dependent on extrapolation modelling.
Health state valuation; EuroQol; EQ-5D
Interpretation of scores from oral health-related quality of life (OHRQoL) instruments, such as the Oral Health Impact Profile (OHIP) is challenging. It was the aim of this study to determine how many oral impacts correspond to one point of the 49-item OHIP using a new approach which translates numeric problem counts into the traditionally used ordinal OHIP response categories.
A sample of 145 consecutively recruited prosthodontic patients seeking treatment or having a routine examination completed the German version of the 49-item OHIP with the original ordinal response format as a self-administered questionnaire. In addition, the numerical frequencies of impairment during the previous month were requested in personal interviews. Based on a multilevel mixed-effects linear regression, we estimated the mean difference with 95% confidence interval (CI) in numerical frequency between two adjacent ordinal responses.
A numerical frequency of 15.2 (CI: 14.8 – 15.7) impacts per month corresponded to one OHIP point. This translates to approximately one impact every other day in the past month.
The oral problem count per day that corresponds to one OHIP-49 point can be used to interpret this instrument’s scores in cross-sectional and longitudinal studies. This number can help to better understand OHRQoL burden for patients, clinicians, and researchers alike.
OHIP; Response format; OHRQoL; Assessment
Facial prostheses are intended to provide a non-operative rehabilitation for patients with acquired facial defects. By improving aesthetics and quality of life (QOL), this treatment involves reintegration of the patient into family and social life. The aim of this study was to evaluate the perception of QOL in adult patients with facial prostheses and to compare this perception with that of a control group.
The study participants consisted of 72 patients, who were divided into three equal-sized groups according to the type of prosthesis (OP- orbital prosthesis, AP- auricular prosthesis, NP - nasal prosthesis) and 24 healthy control participants without any congenital or acquired deformity of face or body. Clinical and socio-demographic data were gathered from each person’s medical chart. Participants completed the Turkish version of the World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF). Descriptive statistics, independent sample t-tests, Pearson's chi-square test, ANOVA, ANCOVA, and Pearson correlation were used to analyse the data.
Compared with the control participants, patients with NP scored lower on the all domains of QOL and all three patient groups had lower scores on overall QOL and its domains of physical and environmental health. Patients with OP reported significantly lower physical health scores than those with AP, while patients with NP reported significantly lower overall QOL and psychological health scores than those with AP. Female patients had lower environmental domain scores than did male patients. The patient’s age and income correlated with social relationships QOL, while the patient’s income and the age of facial prosthesis were correlated with environmental QOL.
Patients with facial prostheses had lower scores in overall QOL, physical and environmental health domains than the control participants. Socio-demographic and clinical characteristics such as age, gender, income, localization of the defect, and age of facial prosthesis were associated with patients’ QOL. These findings may provide valuable information about the specific health needs of these patients that may affect their well-being. Further studies are needed to confirm these results. Use of the WHOQOL-BREF may provide valuable information for determining patients’ needs and priorities as well as for planning and developing comprehensive prosthetic rehabilitation programs.
Quality of life; Facial prosthesis; Acquired facial defect; WHOQOL-BREF
Diabetic Macular Edema (DME) is a common cause of impaired vision and blindness amongst diabetics. If not detected and treated early, the resulting vision loss can lead to considerable health costs and decreased health-related quality of life (HRQoL). The aim of this study was to provide evidence of the psychometric properties of the National Eye Institute - Visual Functioning Questionnaire (VFQ-25) for use in a cohort of DME patients who participated in a clinical efficacy and safety trial of pegaptinib sodium (Macugen).
A phase 2/3 randomised, double masked trial evaluated pegaptanib injection versus sham injection in patients with DME. The analysis was conducted using baseline HRQoL data of the VFQ-25 and the EQ-5D, on a modified intent-to-treat sample of 235 patients. These measures were administered by a trained interviewer by telephone in all but one of the study countries, where face-to-face interviews were conducted in the clinic. The measures were completed in the week prior to baseline, and after 54 weeks of treatment. Distance visual acuity, measured according to the Early Treatment Diabetic Retinopathy Study (ETDRS), was assessed at all time points. Psychometric properties of the VFQ-25 assessed included domain structure, reliability, concurrent and construct validity, responsiveness.
The VFQ-25 was found to consist of 11 domains slightly different than those proposed. Nevertheless, none of the eight established multi-item scales met the criterion for further splitting and the VFQ-25 was scored as in the developers’ instructions. Internal consistency reliability was demonstrated for six out of the eight original multi-item scales, with Cronbach's alpha ranging from 0.58 (Distance Activities) to 0.85 (Vision Specific: Dependency). The VFQ-25 domains generally showed a low to moderate correlation with EQ-5D visual analogue scale (range 0.16-0.43) and with the visual acuity score (range 0.10-0.41). Construct validity was upheld with higher VFQ-25 scores for patients who saw more letters according to the ETDRS. Almost all scales were shown to be responsive with Guyatt's statistic ranging from 0.10 to 0.56 at 54 weeks.
The VFQ-25 has evidence to support its validity and reliability for measuring HRQoL in DME. However, some operating characteristics of the instrument need further consideration and discussion in the case of DME patients. Further research is therefore warranted in this indication.
Diabetic macular edema; Visual functioning questionnaire; Psychometric analyses
The Self Assessment of Treatment (SAT) questionnaire was developed to reflect key patient reported outcomes of Neuropathic Pain (NP) treatments. This study aimed to understand how patients perceived the relevance and ease of understanding of the questions in the SAT and to recommend modifications based on patient and clinician interviews.
Semi-structured interviews were conducted with clinicians and NP patients to provide information regarding treatment attributes and the impact of pain. Patients were debriefed on the SAT, a 5-item scale evaluating pain, activity level, quality of life (QoL) and satisfaction with treatment (recommend treatment and undergo treatment again). The SAT has a recall period reflecting back to the start of treatment. The qualitative analysis software ATLAS.ti 5.0 was used to analyze patient transcripts. Changes to the SAT were integrated into the questionnaire for a second round of debriefing interviews.
Three NP clinicians and 44 patients (20 painful diabetic neuropathy, 16 HIV-associated neuropathy and 8 post herpetic neuralgia) with a mean age of 60.3 (12.3) years and an even gender distribution were interviewed. Patient treatment experience included anticonvulsants (73%), antidepressants (34%), opioids (25%), and topical medications (41%). Pain descriptors and treatment attributes were similar across the three NP groups. Pain relief was judged the most important treatment attribute, followed by ability to undertake activities. Sleep improvement was another important attribute. Activity limitations and QOL were perceived as too broad and non-specific, and were split into 3 concepts each (activity limitations was split into self care, daily and physical activities and QOL was split into sleep, emotions, and social function). A 7-day recall period was introduced. The item stem and response options were made consistent, and a baseline and follow-up questionnaires were developed (except for the satisfaction items) to enable monitoring onset of treatment benefit and change over time.
The content validity of the revised SAT was improved by the qualitative research, and NP treatment benefits are reflected in a more consistent fashion by the changes. Baseline and follow-up versions make it possible to perform assessments of change over time.
Neuropathic pain; Content validity; Self assessment; Questionnaire
Mindful-based interventions improve functioning and quality of life in fibromyalgia (FM) patients. The aim of the study is to perform a psychometric analysis of the Spanish version of the Mindful Attention Awareness Scale (MAAS) in a sample of patients diagnosed with FM.
The following measures were administered to 251 Spanish patients with FM: the Spanish version of MAAS, the Chronic Pain Acceptance Questionnaire, the Pain Catastrophising Scale, the Injustice Experience Questionnaire, the Psychological Inflexibility in Pain Scale, the Fibromyalgia Impact Questionnaire and the Euroqol. Factorial structure was analysed using Confirmatory Factor Analyses (CFA). Cronbach's α coefficient was calculated to examine internal consistency, and the intraclass correlation coefficient (ICC) was calculated to assess the test-retest reliability of the measures. Pearson’s correlation tests were run to evaluate univariate relationships between scores on the MAAS and criterion variables.
The MAAS scores in our sample were low (M = 56.7; SD = 17.5). CFA confirmed a two-factor structure, with the following fit indices [sbX2 = 172.34 (p < 0.001), CFI = 0.95, GFI = 0.90, SRMR = 0.05, RMSEA = 0.06. MAAS was found to have high internal consistency (Cronbach’s α = 0.90) and adequate test-retest reliability at a 1–2 week interval (ICC = 0.90). It showed significant and expected correlations with the criterion measures with the exception of the Euroqol (Pearson = 0.15).
Psychometric properties of the Spanish version of the MAAS in patients with FM are adequate. The dimensionality of the MAAS found in this sample and directions for future research are discussed.
Mindfulness; MAAS; Reliability; Validity; Fibromyalgia
Palliative Care (PC) is an approach that improves the Quality of Life (QoL). A number of QoL assessment tools have been developed and validated in PC. It is not clear how QoL should be measured in PC practice. A procedure of QoL assessment in clinical practice can be defined as a clinical intervention focused on QoL assessment. This is a typical complex intervention that should be appropriately developed and described in all its components and assessed for its effectiveness. The aim of this study is to define a framework to help researchers to develop and evaluate clinical interventions focused on QoL assessment in PC.
A study group of experts in PC and in research methodology was set up to define a framework that would describe the principles of clinical interventions focused on QoL assessment in PC. The study group discussed the WHO Population Screening Principles as a possible useful framework. The new principles had to be developed taking into account the following criteria: 1) specific to PC practice; 2) address a single underlying characteristic; 3) anchored to relevant literature; 4) consistent with the WHO PC definition.
With regard to contents and the format of the principles, discussions occurred among the study group members through a cognitive process.
We reviewed each of the WHO Population Screening Principles and adapted them to QoL assessment, taking into account the defined criteria. As a result, a new framework, the QoL Assessment Principles in Palliative Care was developed. It consisted of 4 sections, for a total of 11 principles.
The WHO Screening Principles framework was used to outline the eleven essential principles to be considered in developing and/or evaluating clinical interventions focused on QoL assessment in PC. The QoL Assessment Principles in Palliative Care identified could represent a methodological and ethical standard to be considered when developing and evaluating a clinical intervention focused on QoL assessment in PC.
Quality of life; Outcome assessment; Palliative care; Complex intervention
An instrument was developed in Canada to assess impairments related to oral functioning of individuals with four years of age or older with Down syndrome (DS). The present study attempted to carry out the cross-cultural adaptation and validation of the instrument for the Brazilian Portuguese language and to test its reliability and validity.
After translation and cross-cultural adaptation, the instrument was tested on caregivers of people with DS. Clinical examination for malocclusion was carried out in people with DS by two calibrated examiners. Inter and Intra examiner agreement was assessed by Intraclass Correlation Coefficient (ICC) and ranged from 0.92 to 0.97 respectively. Total of 157 people with DS and their caregivers were able to compose the sample. They were selected from eight institutions for people with DS in five cities of southeastern Brazil. The mean age of people with DS was 20.7 [±13.1] and for caregivers was 53.1 [±13.7]. The mean instrument score was 18.6 [±9.0]. Internal reliability ranged from 0.49 to 0.80 and external reliability ranged from 0.78 to 0.88. Construct validity was verified by significant correlations identified between malocclusion and the total instrument; and caregivers’ educational level and the instrument (p<0.05). Discriminant validity was proved as the instrument presented different mean comparing people with DS and non-DS (p<0.05).
Initial validity tests indicated that the instrument related to the oral health for people with DS may be a valid instrument to this segment of the population in Brazil.
Down syndrome; Cross-cultural adaptation; Validation; Malocclusion; Oral functioning; Oral health