Deferasirox, deferiprone and desferrioxamine treatment in thalassemia major patients: cardiac iron and function comparison determined by quantitative magnetic resonance imaging

Background

Oral deferiprone was suggested to be more effective than subcutaneous desferrioxamine for removing heart iron. Oral once-daily chelator deferasirox has recently been made commercially available but its long-term efficacy on cardiac iron and function has not yet been established. Our study aimed to compare the effectiveness of deferasirox, deferiprone and desferrioxamine on myocardial and liver iron concentrations and bi-ventricular function in thalassemia major patients by means of quantitative magnetic resonance imaging.

Design and Methods

From the first 550 thalassemia subjects enrolled in the Myocardial Iron Overload in Thalassemia network, we retrospectively selected thalassemia major patients who had been receiving one chelator alone for longer than one year. We identified three groups of patients: 24 treated with deferasirox, 42 treated with deferiprone and 89 treated with desferrioxamine. Myocardial iron concentrations were measured by T2* multislice multiecho technique. Biventricular function parameters were quantitatively evaluated by cine images. Liver iron concentrations were measured by T2* multiecho technique.

Results

The global heart T2* value was significantly higher in the deferiprone (34±11ms) than in the deferasirox (21±12 ms) and the desferrioxamine groups (27±11 ms) (P=0.0001). We found higher left ventricular ejection fractions in the deferiprone and the desferrioxamine versus the deferasirox group (P=0.010). Liver iron concentration, measured as T2* signal, was significantly lower in the desferrioxamine versus the deferiprone and the deferasirox group (P=0.004).

Conclusions

The cohort of patients treated with oral deferiprone showed less myocardial iron burden and better global systolic ventricular function compared to the patients treated with oral deferasirox or subcutaneous desferrioxamine.     

Iron-chelation therapy: an update

Chronically transfused patients develop iron overload that leads to organ damage and ultimately to death. The introduction of the iron-chelating agent, desferrioxamine mesylate, dramatically improved the life expectancy of these patients. However, the very demanding nature of this treatment (subcutaneous continuous infusion via a battery-operated portable pump) has been the motivation for attempts to develop alternative forms of treatment that would facilitate the patients' compliance. In this review, we describe the most important advances in iron-chelating therapy. In particular, we analyze a new method of administering desferrioxamine mesylate (twice daily subcutaneous bolus injections) and a novel, orally active iron chelator (ICL670A). We also present a meta-analysis of the largest trials on the oral iron chelator deferiprone and the results of combined therapy (deferiprone and desferrioxamine).     

Assessment of the impact of treatment on quality of life of patients with haemophilia A at different ages: insights from two clinical trials on turoctocog alfa

Haemophilia and its treatment interfere with patients' life, so health‐related quality of life (HRQoL) should be assessed when evaluating treatments. This study investigated the HRQoL of patients with haemophilia A treated prophylactically with a new recombinant factor VIII. Two phase 3 trials investigated turoctocog alfa in patients with severe haemophilia A: one in children, one in adults and adolescents. HRQoL was a secondary endpoint assessed by the HAEMO‐QOL age‐specific, self‐administered questionnaires. Parent‐completed versions were also included for parents of children and adolescents. All HAEMO‐QOL questionnaires allow the calculation of domain‐specific and total scores ranging from 0 to 100, lower scores indicating better HRQoL. Mean change in all scores was described for 25 children aged 4–7 years, 21 children aged 8–12 years, 18 adolescents aged 13–18 years and 129 adults, overall, and according to the treatment regimen received prior to the study (on‐demand; prophylaxis; mixed). Mean changes in HAEMO‐QOL total score were 1.4 for children aged 4–7 years, ?2.6 for children aged 8–12 years, ?5.8 for adolescents and ?1.6 for adults. In parent‐completed versions, mean changes in total score were ?6.0 for children aged 4–7 years, ?4.7 for children aged 8–12 years, and ?10.0 for adolescents. Patients receiving on‐demand treatment before the trial showed greater improvement in HRQoL scores than patients already on prophylaxis. HRQoL of patients remained fairly stable over the course of the trials. However, improvements were observed for adolescents. Switching to prophylaxis was identified as a potential driver of improvement of HRQoL in patients with haemophilia A.     

Intensive Chelation Therapy in β-Thalassemia and Possible Adverse Cardiac Effects of Desferrioxamine

Combination chelation therapy with desferrioxamine and deferiprone has recently been suggested as a more effective tissue iron-chelating treatment for transfusion-dependent beta-thalassemia patients, although a standard dosage protocol has not yet been established. We describe a thalassemia major patient who had been treated with combination therapy with desferrioxamine and deferiprone and who was referred to us for faintness and dizziness associated with electrocardiographic ST-T changes and arrhythmia. A brief interruption of the treatment and a subsequent decrease in the drug doses caused the reversion of symptoms and findings. This response prompted us to speculate that a causal relationship existed between the observed abnormalities and the intensive chelation therapy. The possibility of this electrical instability as an adverse cardiac event occurring in the context of treatment with these chelating agents raises questions about the time of application of this therapy, the regimen dosages, and follow-up of such patients.     

Quality of life in a clinical sample of obese children

OBJECTIVES: To measure health-related quality of life (HRQoL) in a clinical sample of obese children by child self-report and parent-proxy report; to compare quality of life assessments provided by obese children and their parents; to assess differences in quality of life between the obese clinical sample and healthy control children. DESIGN: Pairwise comparison of obese children matched for age, gender and socio-economic status with non-obese controls. SUBJECTS: One hundred and twenty-six obese children (body mass index (BMI) >/=98th centile) and 71 lean control children (BMI <85th centile). Controls were matched with 71 children from the obese clinical group (mean age 8.6, standard deviation (s.d.) 1.9 years; 33 M/38 F). MEASUREMENT: The Paediatric Quality of Life Inventory (UK) version 4 was self-administered to parents and to children aged 8-12 years and interview was administered to children aged 5-7 years. This questionnaire assessed physical, social, emotional and school functioning from which total, physical and psychosocial health summary scores were derived. RESULTS: In the obese clinical group (n=126), parent proxy-reported quality of life was low for all domains. In the obese clinical group, parent-reported scores were significantly lower than child self-reported scores in all domains except physical health and school functioning. Parent-proxy reports were significantly higher for healthy controls than obese children in all domains (median total score 85.2 vs 64.7; 95% confidence interval (CI) 15.6, 24.1). For child self-reports, only physical health was significantly higher for healthy controls than obese children (median score 81.3 vs 75.0; 95% CI 3.1, 12.5). CONCLUSIONS: HRQoL is impaired in clinical samples of obese children compared to lean children, but the degree of impairment is likely to be greatest when assessed using the parent perspective rather than the child perspective.     

Iron-chelating and free-radical scavenging activities of microwave-processed green tea in iron overload

Secondary iron overload is found in beta-thalassemia (thal) patients because of increased dietary iron absorption and multiple blood transfusions. Excessive iron catalyzes free-radical generation, leading to oxidative damage and vital organ dysfunction. Non-transferrin-bound iron (NTBI) detected in thalassemic plasma is highly toxic and chelatable. Though used to treat iron overload, desferrioxamine (DFO) and deferiprone (L1) also have adverse effects. Green tea (GT) shows many pharmacological effects, particularly antioxidative and iron-chelating capacities. This study was performed to investigate the ability of GT extracts to reduce plasma NTBI concentration and oxidative stress in vitro. The Fe(3+) was found to bind to GT crude extract and form a complex. Green tea crude extract time- and dose-dependently decreased plasma NTBI concentration and counteracted the increase of oxidative stress in both Fe(2+)-EDTA-treated human plasma and erythrocytes. Green tea is a bifunctional natural product that could be relevant for management of iron overload and oxidative stress.     

Interpretation of quality of life scores in multiple myeloma by comparison with a reference population and assessment of the clinical importance of score differences

OBJECTIVES: Without clear guidelines, clinicians and health care providers are often uncertain how to interpret (quality of life) QOL scores. To facilitate the interpretation, QOL scores of multiple myeloma patients at diagnosis were compared with the scores of a reference population, and the clinical significance of QOL score differences and of changes in scores over time was assessed. METHODS: Data from two prospective Nordic Myeloma Study Group trials (221 patients <60 yr treated with high dose chemotherapy, and 203 patients >60 yr treated with melphalan and prednisone) were analysed. The EORTC QLQ-C30 questionnaire was used. The results were compared with the scores of an age- and gender-adjusted Norwegian reference population (n = 3000), using a regressional approach. The magnitude of the observed differences and of score changes during follow-up was estimated as effect size [score difference (SD)] and according to a subjective rating system as small, moderate or large. RESULTS: At diagnosis, the most distressing problems were pain and fatigue, reduced physical functioning, limitations in role functioning and reduced overall QOL. These differences from the reference population were statistically significant (P < 0.001), and large or moderate according to the rating systems. After the start of treatment, small to moderate improvement in mean QOL scores were observed for most domains. CONCLUSION: Comparison with a reference population eases the interpretation of QOL scores and prevents overestimation of symptoms and underestimation of subjective treatment response. The agreement between the two methods to evaluate the meaning of differences and changes in QOL scores was good.     

Health-related quality of life among adults living with HIV: a cross-sectional survey in Armenia

ABSTRACT

Few studies have examined health-related quality of life (HRQoL) among people living with HIV (PLWHIV) in Eastern Europe and Central Asia. We conducted a cross-sectional survey of 180 PLWHIV aged 18 years+ in Armenia who were on cART and used the 36-Item Short-Form Health Survey to assess HRQoL. The highest HRQoL domain score was 85.3 (SD 24.7) for physical functioning, followed by 82.1 (SD 25.0) for pain, 77.9 (SD 24.2) for social functioning, 76.4 (SD 39.6) for emotional role-functioning, 71.1 (SD 39.7) for physical role-functioning, and 64.0 (SD 20.3) for energy/fatigue, 63.7 (SD 22.7) for emotional well-being and 63.4 for general health 63.4 (SD 21.2). In the physical domain, chronic comorbidities and low emotional support were associated with worse physical functioning, physical role-functioning, general health and pain scores (p?<?0.05). Unemployment and hepatitis C coinfection were associated with worse physical role functioning and pain scores (p?<?0.01). As for mental HRQoL, we found that unemployment, chronic comorbidities, and lower emotional support were associated with poorer emotional well-being, energy, and emotional role-functioning scores (p?<?0.05). These findings suggest that improved social support, employment opportunities, mental health services and integrated care for noncommunicable comorbidities may improve HRQoL in Armenia and similar settings.     

Patients receiving HLA-haploidentical/partially matched related allo-HSCT can achieve desirable health-related QoL that is comparable to that of patients receiving HLA-identical sibling allo-HSCT

To investigate the health-related quality of life (HRQoL) of patients receiving allogeneic hematopoietic SCT (allo-HSCT) from HLA-haploidentical/partially matched related donors (HID/PMRD) and to compare this value with that of patients receiving allo-HSCT from HLA-identical sibling donor (ISD), a total of 350 patients receiving allo-HSCT were enrolled in a study (ISD: 173; HID/PMRD: 177). HRQoL post transplantation was evaluated by an SF-36 questionnaire. The effect of various factors on the HRQoL was analyzed through COX regression. Compared with the ISD group, patients in the HID/PMRD group had higher scores in physical functioning, general health, bodily pain, vitality and emotional role functioning, and these patients functioned significantly better on the physical and mental component summaries. Also, long-term survivors exhibit better HRQoL. Measured by multivariate analysis, extensive chronic GVHD was observed to have a strongly negative impact on patients' HRQoL, while male gender status, lower age when receiving allo-HSCT and returning to work or school were associated with positive impacts on at least one subscale. These results showed that the HRQoL of patients receiving HID/PMRD hematopoietic SCT (HSCT) is comparable to that of patients receiving ISD HSCT, and HLA disparity is not the factor affecting the HRQoL.     

Health-related quality of life and self-esteem in patients with diabetic foot ulcers: results of a cross-sectional comparative study

To evaluate health-related quality of life (HRQoL) and self-esteem in patients with diabetic foot ulcers (DFUs), a cross-sectional, comparative study was conducted among 35 consecutive patients with diabetes mellitus (DM) attending outpatient clinics in Pouso Alegre, Brazil. Fifteen (15) patients with and 20 without a DFU participated in the study. Demographic variables were obtained and HRQoL and self-esteem were assessed using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and Rosenberg Self-Esteem Scale. In both groups, 80% of patients were women. Average age did not differ significantly between the DFU and control groups (average 56 [SD 8.42] and 52 years [SD 6.68], respectively) but disease duration was significantly longer (P < 0.001) in the DFU (mean 12 years, range 3 to 24 years) than in the control group (mean 8 years, range 1 to 21 years). Mean HRQoL scores in all domains were lower in the DFU than in the control group with significant differences in the following domains: physical functioning (P = 0.043), role physical (P = 0.003), social functioning (P = 0.022), and role emotional (P = 0.001). Self-esteem scores were similar in both groups. The results of this study confirm that patient HRQoL is negatively affected by the presence of a DFU. Wound prevention programs for patients with DM may help reduce the scope of this problem while DFU treatment programs that include psychological support may improve patient QoL.     

Quality of life in patients with Takayasu's arteritis is impaired and comparable with rheumatoid arthritis and ankylosing spondylitis patients

The aims of the study were to assess the health-related quality of life (QOL) in patients with Takayasu's arteritis (TA) by two different generic QOL instruments and to compare the results with those patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and healthy controls (HC). A cross-sectional study was performed in 51 patients with TA (41 women; mean age 38.4 +/- 13.5), 43 RA (36 women; 55.2 +/- 9.6), 31 AS (12 women; 41.2 +/- 13.1), and 75 HC (53 women; 38.8 +/- 10.9). Quality of life was assessed by using Short-Form 36 (SF-36) and Nottingham Health Profile (NHP). Separate dimensions of SF-36 and NHP and physical and mental summary scores of SF-36 as well were compared between patients and control groups. Physical and mental health summary scores and all SF-36 subscales, except for social functioning, were significantly lower in patients with TA than healthy controls. No significant differences between TA, RA, and AS patients were found in all SF-36 subscales and summary scores. NHP scores for energy level, pain, emotional reactions, and physical mobility were significantly higher in TA patients than controls. All NHP subscales, except for pain, were comparable in patients with TA, RA, and AS. Pain score was worse in RA patients. The NHP scores for sleep and social isolation were not different between patients and controls. Many aspects of QOL in patients with TA are significantly impaired in comparison with local healthy controls and similar to those in patients with RA and AS.     

Quality of life and work in patients with rheumatoid arthritis and ankylosing spondylitis of working age

OBJECTIVE: To investigate the relationship between work and quality of life (QOL) in patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS) aged 16-59. METHODS: 1056 patients with RA and 658 with AS were included in the study. Data were obtained by postal questionnaire, which included several generic and disease related QOL instruments. Separate dimensions and physical and mental summary scores from the SF-36 were compared. Stepwise multiple regression was performed to study the relationship between work and physical and mental health related QOL, including disease related factors, coping, and fatigue. RESULTS: Physical health related QOL was reported to be worse, and mental health related QOL better, in RA than in AS in people of working age. No differences between RA and AS were found in somatic pain, physical role functioning, social functioning, emotional role functioning, vitality, or general health perception; nor were there any significant differences in fatigue and behavioural coping styles. Work was positively associated with physical health related QOL in both groups and, after disease characteristics, was the most important determinant. No association was found with mental health related QOL. CONCLUSIONS: Although physical health related QOL was worse in patients with RA, the impact on several dimensions of health related QOL in patients with RA and AS of working age under rheumatological care was comparable. Patients with RA and AS experienced similar limitations in physical role functioning, including work. Work is an important independent external determinant of physical health related QOL, but not of mental health related QOL.     

Anxiety and depression affects life and sleep quality in adults with beta-thalassemia

Purpose  The aim of this study was to investigate the association of anxiety and depression symptoms with health related quality of life (HRQoL) and sleep quality in patients with beta-thalassemia. Methods  In a cross-sectional study between 2006 and 2007, 292 thalassemic patients were assessed for symptoms of anxiety and depression (Hospital Anxiety Depression Scale; HADS), HRQoL (Short Form-36, SF-36) and quality of sleep (Pittsburgh Sleep Quality Index; PSQI). Linear regression models were used to determine possible predictive value of high anxiety and depressive symptoms on HRQoL and sleep quality, separately. Results  Mental and physical quality of life scores were predicted by symptoms of depression and somatic comorbidities. Total sleep quality was predicted by anxiety symptoms and somatic comorbidities. Conclusions  Screening for anxiety and depression in patients with thalassemia is essential. Further studies should test if appropriate treatment of these conditions may improve patients HRQoL and sleep quality or not.     

Iron-Chelating and Free-Radical Scavenging Activities of Microwave-Processed Green Tea in Iron Overload

Secondary iron overload is found in β-thalassemia (thal) patients because of increased dietary iron absorption and multiple blood transfusions. Excessive iron catalyzes free-radical generation, leading to oxidative damage and vital organ dysfunction. Non-transferrin-bound iron (NTBI) detected in thalassemic plasma is highly toxic and chelatable. Though used to treat iron overload, desferrioxamine (DFO) and deferiprone (L1) also have adverse effects. Green tea (GT) shows many pharmacological effects, particularly antioxidative and iron-chelating capacities. This study was performed to investigate the ability of GT extracts to reduce plasma NTBI concentration and oxidative stress in vitro. The Fe³⁺ was found to bind to GT crude extract and form a complex. Green tea crude extract time- and dose-dependently decreased plasma NTBI concentration and counteracted the increase of oxidative stress in both Fe ²⁺-EDTA-treated human plasma and erythrocytes. Green tea is a bifunctional natural product that could be relevant for management of iron overload and oxidative stress.     

Effect of desferrioxamine and deferiprone on osteocalcin secretion in osteoblast-type cells

Desferrioxamine and deferiprone are both metal-chelating drugs often used in aluminum-overloaded dialysis patients. In these patients, desferrioxamine produces an improvement on bone mineralisation without a relevant decrease in bone aluminum. Thus, desferrioxamine might have a direct effect on bone cells. The aim of this study was to assess the effect of desferrioxamine and deferiprone on 1,25(OH)2D3-stimulated osteocalcin secretion in osteoblast--like cells. The study was carried out in MG-63 cell cultures. Cells were seeded at a density of 15,000 cel/cm2 and grown to confluence for 72 hours in DMEM supplemented with 10% FCS. The medium was then replaced by another medium containing 1% BSA, 10(-9) M 1,25(OH)2D3 and desferrioxamine 5, 10, 20, 40, 60, 80 microM or deferiprone 15, 30, 60, 120, 180, 240 microM. Tris-HCl at pH 7.4 was used as control. After 48 hours, supernatants were collected for the measurement of secreted osteocalcin. Desferrioxamine and deferiprone, at high doses (desferrioxamine: 60 microM, 80 microM; deferiprone: 180 microM, 240 microM), inhibited the 1,25(OH)2D3-induced osteocalcin secretion. On the contrary, at lower doses (desferrioxamine 5 microM; deferiprone 15 microM) stimulated the secretion. In summary, these results suggest that desferrioxamine and deferiprone exert a direct effect on bone cell metabolism that might be independent from their metal-chelating properties.     

Neurocognitive impairment influences quality of life in HIV-infected patients receiving HAART

The objective of the study was to determine the association of neurocognitive impairment with health-related quality of life (HRQoL) in patients receiving highly active antiretroviral therapy (HAART). Seventy subjects were cross-sectionally analysed with a standardized neuropsychological test battery and a questionnaire including an Italian translation of the MOS-HIV Health Survey. The presence of neurocognitive impairment was significantly associated with lower HRQoL scores: pain (P = 0.03), physical functioning (P = 0.01), role functioning (P = 0.01), social functioning (P = 0.029), mental health (P = 0.001), energy (P = 0.036), health distress (P = 0.002), cognitive functioning (P = 0.05), current health perception (P <0.001), physical health summary score (PHS) (P = 0.005), mental health summary score (MHS) (P = 0.002). Years of education (odds ratio [OR] 0.79; 95% confidence interval [CI] 0.65-0.96), PHS (OR 0.71; 95% CI 0.54-0.95) and MHS (OR 0.67; 95% CI 0.51-0.88) were also associated with cognitive impairment. Neurocognitive impairment in patients receiving HAART was associated with reduced HRQoL. Identifying cognitive impairment may provide motivation for additional treatment to help patients to compensate for deficits in functioning.     

Poor quality of life among untreated Thai and Cambodian children without severe HIV symptoms

There are limited data on quality of life (QOL) 1 in untreated HIV-infected children who do not have severe HIV symptoms. Moreover, such data do not exist for Asian children. Poor QOL could be a factor in deciding if antiretroviral therapy (ART) should be initiated. Thai and Cambodian children (n=294), aged 1-11 years, na?ve to ART, with mild to moderate HIV symptoms and CD4 15-24% were enrolled. Their caregivers completed the Pediatric AIDS Clinical Trials Group QOL questionnaire prior to ART commencement. Six QOL domains were assessed using transformed scores that ranged from 0 to 100. Higher QOL scores indicated better health. Mean age was 6.1 (SD 2.8) years, mean CD4 was 723 (SD 369) cells/mm(3), 57% was female, and%CDC N:A:B was 2:63:35%. One-third knew their HIV diagnosis. Mean (SD) scores were 69.9 (17.6) for health perception, 64.5 (16.2) for physical resilience, 84.2 (15.6) for physical functioning, 77.9 (16.3) for psychosocial well-being, 74.7 (28.7) for social and role functioning, 90.0 (12.1) for health care utilization, and 87.4 (11.3) for symptoms domains. Children with CD4 counts above the 2008 World Health Organization (WHO) ART-initiation criteria (n=53) had higher scores in health perception and health care utilization than those with lower CD4 values. Younger children had poorer QOL than older children despite having similar mean CD4%. In conclusion, untreated Asian children without severe HIV symptoms had relatively low QOL scores compared to published reports in Western countries. Therapy initiation criteria by the WHO identified children with lower QOL scores to start ART; however, children who did not fit ART-initiation criteria and those who were younger also displayed poor QOL. QOL assessment should be considered in untreated children to inform decisions about when to initiate ART.     

Multivariate analysis of factors influencing quality of life and utility in patients with haemophilia.

BACKGROUND AND OBJECTIVES: Although several studies have determined quality of life (QOL) in patients with hemophilia, generic questionnaires have rarely been used. The objectives of our study were; 1) to measure QOL and utility in patients with hemophilia using the Short Form 36 (SF-36) and the EuroQOL questionnaires; 2) to evaluate the influence of some clinical variables on QOL and utility; 3) to assess the correlation between the two questionnaires. DESIGN AND METHODS: All consecutive patients with hemophilia were asked to complete the SF-36 and the EuroQOL questionnaires. The following information was recorded from each patient: age, type of hemophilia, severity of disease, HCV and HIV infection, number of bleeding episodes and cumulative dose of coagulation factors over the previous year. These items were entered into a multivariate analysis to assess their effect on QOL. Correlation analyses were conducted to evaluate the relationship between the EuroQOL and SF-36. RESULTS: Fifty-six patients completed the SF-36 and the EuroQOL questionnaires. The mean scores of the SF-36 ranged from 55.2 (general health) to 74.7 (social functioning). The EuroQOLself-classifier and the EuroQOLvas showed a mean score of 0.67 (SD=0.26) and 0.66 (SD=0.17), respectively. Among the clinical variables, age significantly influenced both the EuroQOL and the SF-36 scores. The EuroQOL indices showed a statistically significant correlation with each dimension of the SF-36. INTERPRETATION AND CONCLUSIONS: Our study quantified the degree to which QOL is impaired in patients with hemophilia by using both a generic questionnaire and a utility-based approach.     

Health-related quality of life of diabetic foot ulcer patients and their caregivers

Aims/hypothesis The effect of a foot ulcer on health-related quality of life (HRQoL) of patients with diabetes mellitus and their caregivers is unclear, and was therefore evaluated prospectively in this multicentre study.Methods HRQoL according to the 36-item health-related quality of life questionnaire (SF-36) of 294 patients (ulcer duration 4 weeks) and 153 caregivers was analysed at baseline (time-point zero [T0]), once the ulcer was healed or after 20 weeks (time-point 1 [T1]), and 3 months later (time-point 2 [T2]). Patients with severe ischaemia were excluded.Results The mean age of the patients was 60 years, 72% were male, and time since diagnosis of diabetes was 17 years. Patients reported a low HRQoL on all SF-36 subscales. At T1, HRQoL scores in physical and social functioning were higher in patients with a healed vs a non-healed ulcer (p<0.05). At T2, these differences were larger, with higher scores for physical and social functioning, role physical and the physical summary score (all p<0.05). Within-group analysis revealed that HRQoL improved in different subscales in patients with a healed ulcer and worsened in patients with a persistent ulcer from T0 to T2 (all p<0.05). The caregivers of patients with a persisting ulcer had more emotional difficulties at T2.Conclusions/interpretation Diabetic patients with a healed foot ulcer had a higher HRQoL than patients with a persisting ulcer. Healing of a foot ulcer resulted in a marked improvement of several SF-36 subscales 3 months after healing (from T0 to T2). HRQoL declined progressively when the ulcer did not heal. A diabetic foot ulcer appeared to be a large emotional burden on the patients caregivers, as well.     

Health-related quality of life in perinatally HIV-infected children in the Netherlands

Combination antiretroviral therapy (cART) can alter HIV infection in children into a chronic condition. Studies investigating health-related quality of life (HRQoL) in HIV-infected children are scarce, and lacking from Western Europe. This study aimed to compare the HRQoL of clinically stable perinatally HIV-infected children to healthy, socioeconomically (SES)-matched controls as well as the Dutch norm population, and to explore associations between HIV and cART-related factors with HRQoL. HIV-infected and healthy children aged 8–18 years completed the Pediatric Quality of Life Inventory? 4.0 (PedsQL?). We determined differences between groups on PedsQL? mean scores, and the proportion of children with an impaired HRQoL per group (≥1 SD lower than the Dutch norm population). Logistic regression models were used to explore associations between disease-related factors and HRQoL impairment. In total, 33 HIV-infected and 37 healthy children were included. There were no differences in the mean PedsQL? subscales between HIV-infected children and both control groups. The proportion of children with an impaired HRQoL was higher in the HIV-infected group (27%) as compared to the healthy control group (22%) and the Dutch norm (14%) on the school functioning subscale (HIV vs. Dutch norm: P?=?.045). Mean scores of HRQoL of perinatally HIV-infected children in the Netherlands were not different from a SES-matched control group, or from the Dutch norm population. However, the HIV-infected group did contain more children with HRQoL impairment, suggesting that HIV-infected children in the Netherlands are still more vulnerable to a compromised HRQoL.