Health-Related Quality of Life in Patients with Primary Cutaneous Amyloidosis

Background

Primary cutaneous amyloidosis (PCA) is a relatively rare and itchy skin disorder characterized by amyloid deposits in the superficial dermis. The cosmetic disfigurement and severe pruritus dramatically affects the patient’s quality of life. In spite of the prevalence of the disease in China, the quality of life (QoL) impact of the PCA has not been well defined and is the focus of this study.

Objective

To examine the HRQoL of patients with PCA and to evaluate the association between HRQoL scores, disease, and socio-demographic determinants.

Methods

A total of 104 PCA patients and 101 healthy participants completed the questionnaires. HRQoL was measured using dermatology life quality index (DLQI) and SF-36. The socio demographic and clinical data such as age, sex, duration of disease and distribution of lesion pattern were analyzed mainly by hierarchical multiple regression analyses.

Results

Patients with PCA experienced significantly impaired health-related quality of life. The mean DLQI score was 9.05. Younger age, female gender, more pruritus and distribution pattern were independent predictor correlates of the high DLQI scores. The PCA group showed significantly decreasing average scores in several aspects of psychological symptoms, including SF, RE and MH.

Conclusions

PCA disease has a negative impact on the HRQoL of patients, and the HRQoL is associated with various disease characteristics. In conjunction with medical interventions, psychological and sociocultural assessment and intervention should be an essential part of the management of these cases.     

Risks and Benefits of Nalmefene in the Treatment of Adult Alcohol Dependence: A Systematic Literature Review and Meta-Analysis of Published and Unpublished Double-Blind Randomized Controlled Trials

Background

Nalmefene is a recent option in alcohol dependence treatment. Its approval was controversial. We conducted a systematic review and meta-analysis of the aggregated data (registered as PROSPERO 2014:CRD42014014853) to compare the harm/benefit of nalmefene versus placebo or active comparator in this indication.

Methods and Findings

Three reviewers searched for published and unpublished studies in Medline, the Cochrane Library, Embase, ClinicalTrials.gov, Current Controlled Trials, and bibliographies and by mailing pharmaceutical companies, the European Medicines Agency (EMA), and the US Food and Drug Administration. Double-blind randomized clinical trials evaluating nalmefene to treat adult alcohol dependence, irrespective of the comparator, were included if they reported (1) health outcomes (mortality, accidents/injuries, quality of life, somatic complications), (2) alcohol consumption outcomes, (3) biological outcomes, or (4) treatment safety outcomes, at 6 mo and/or 1 y. Three authors independently screened the titles and abstracts of the trials identified. Relevant trials were evaluated in full text. The reviewers independently assessed the included trials for methodological quality using the Cochrane Collaboration tool for assessing risk of bias. On the basis of the I2 index or the Cochrane’s Q test, fixed or random effect models were used to estimate risk ratios (RRs), mean differences (MDs), or standardized mean differences (SMDs) with 95% CIs. In sensitivity analyses, outcomes for participants who were lost to follow-up were included using baseline observation carried forward (BOCF); for binary measures, patients lost to follow-up were considered equal to failures (i.e., non-assessed patients were recorded as not having responded in both groups). Five randomized controlled trials (RCTs) versus placebo, with a total of 2,567 randomized participants, were included in the main analysis. None of these studies was performed in the specific population defined by the EMA approval of nalmefene, i.e., adults with alcohol dependence who consume more than 60 g of alcohol per day (for men) or more than 40 g per day (for women). No RCT compared nalmefene with another medication. Mortality at 6 mo (RR = 0.39, 95% CI [0.08; 2.01]) and 1 y (RR = 0.98, 95% CI [0.04; 23.95]) and quality of life at 6 mo (SF-36 physical component summary score: MD = 0.85, 95% CI [−0.32; 2.01]; SF-36 mental component summary score: MD = 1.01, 95% CI [−1.33; 3.34]) were not different across groups. Other health outcomes were not reported. Differences were encountered for alcohol consumption outcomes such as monthly number of heavy drinking days at 6 mo (MD = −1.65, 95% CI [−2.41; −0.89]) and at 1 y (MD = −1.60, 95% CI [−2.85; −0.35]) and total alcohol consumption at 6 mo (SMD = −0.20, 95% CI [−0.30; −0.10]). An attrition bias could not be excluded, with more withdrawals for nalmefene than for placebo, including more withdrawals for safety reasons at both 6 mo (RR = 3.65, 95% CI [2.02; 6.63]) and 1 y (RR = 7.01, 95% CI [1.72; 28.63]). Sensitivity analyses showed no differences for alcohol consumption outcomes between nalmefene and placebo, but the weight of these results should not be overestimated, as the BOCF approach to managing withdrawals was used.

Conclusions

The value of nalmefene for treatment of alcohol addiction is not established. At best, nalmefene has limited efficacy in reducing alcohol consumption.     

Quality of Life and Associated Socio-Clinical Factors after Encephalitis in Children and Adults in England: A Population-Based,Prospective Cohort Study

Objective

We sought to measure HRQoL in all-cause encephalitis survivors and assess the impact of various socio-clinical factors on outcome.

Methods

We used a prospective cohort study design, using the short-form 36 (SF-36) to measure the HRQoL in patients 15 years and older, and the short-form 10 (SF-10) for patients less than 15 years old. We posted questionnaires to individuals six months after discharge from hospital. All scores were normalised to the age- and sex-matched general population. We used multivariate statistical analysis to assess the relative association of clinical and socio-demographic variables on HRQoL in adults.

Results

Of 109 individuals followed-up, we received 61 SF-36 and twenty SF-10 questionnaires (response rate 74%). Patients scored consistently worse than the general population in all domains of the SF-36 and SF-10, although there was variation in individual scores. Infectious encephalitis was associated with the worst HRQoL in those aged 15 years and over, scoring on average 5.64 points less than immune-mediated encephalitis (95% CI −8.77– −2.89). In those aged less than 15 years the worst quality of life followed encephalitis of unknown cause. Immuno compromise, unemployment, and the 35–44 age group all had an independent negative association with HRQoL. A poor Glasgow Outcome Score was most strongly associated with a poor HRQoL. Less than half of those who had made a ‘good’ recovery on the score reported a HRQoL equivalent to the general population.

Conclusions

Encephalitis has adverse effects on the majority of survivors’ wellbeing and quality of life. Many of these adverse consequences could be minimised by prompt identification and treatment, and with better rehabilitation and support for survivors.     

Does Future Diabetes Risk Impair Current Quality of Life? A Cross-Sectional Study of Health-Related Quality of Life in Relation to the Finnish Diabetes Risk Score (FINDRISC)

Objectives

Present study examines the relationship between the estimated risk of developing type 2 diabetes (T2D) and health-related quality of life (HRQoL). We quantify the association between Finnish Diabetes Risk Score (FINDRISC) and HRQoL, and examine the potential use of FINDRISC as tool to evaluate HRQoL indirectly.

Methods

We conducted a cross-sectional study comprising 707 Finnish people without a diagnosis of T2D between the ages of 51 and 75 years. The risk of developing T2D was assessed using the validated and widely used FINDRISC (range 0–26 points), and quality of life was measured using two preference-based HRQoL instruments (15D and SF-6D) and one health profile instrument (SF-36). Effects of the individual FINDRISC items and demographic and clinical characteristics, such as co-morbidities, on HRQoL were studied using multivariable Tobit regression models.

Results

Low HRQoL was significantly and directly associated with the estimated risk of developing T2D. An approximate 4–5 point change in FINDRISC score was observed to be associated with clinically noticeable changes in the preference-based instrument HRQoL index scores. The association between HRQoL and the risk of developing T2D was also observed for most dimensions of HRQoL in all applied HRQoL instruments. Overall, old age, lack of physical activity, obesity, and history of high blood glucose were the FINDRISC factors most prominently associated with lower HRQoL.

Conclusions

The findings may help the health care professionals to substantiate the possible improvement in glucose metabolism and HRQoL potentially achieved by lifestyle changes, and better convince people at high risk of T2D to take action towards healthier lifestyle habits. FINDRISC may also provide an accurate proxy for HRQoL, and thus by estimating the risk of T2D with the FINDRISC, information about patients’ HRQoL may also be obtained indirectly, when it is not feasible to use HRQoL instruments.     

Quality of Life,Safety and Efficacy Profile of Thermostable Flolan in Pulmonary Arterial Hypertension

Background

Flolan (epoprostenol sodium) is most commonly prescribed to patients with severe pulmonary arterial hypertension (PAH) owing to the requirement that the drug be delivered by continuous intravenous infusion and the reconstituted solution may only be administered up to 24 hours when it is maintained between a temperature of 2°C and 8°C. The aim of this single-arm, open label study was to describe the effects of the new thermostable formulation of Flolan on health-related quality of life (HRQoL) and ease of administration in subjects switching from the currently marketed Flolan to the reformulated product.

Methods

Following a 4-week run-in period and after 4 weeks of treatment with the reformulated product, patients completed the SF-36 HRQoL questionnaire and a study-specific questionnaire evaluating ease of administration, along with World Health Organization (WHO) functional class, six-minute walked distance (6MWD) and N-terminal-pro B-type natriuretic peptide (NT-proBNP) assessment.

Results

16 participants completed the study. The SF-36 scores remained unchanged from baseline to Week 4. Conversely, there were small improvements for the majority of the study-specific questionnaire items and 14 (88%) subjects preferred the reformulated product to the currently marketed Flolan. There was no significant change in the dose of reformulated product, 6MWD, Borg dyspnoea index, WHO functional class and mean NT-proBNP levels. No significant changes in haemodynamic parameters were seen from baseline to 2 hours post transition in a subset of patients undergoing catheterization.

Conclusion

The reformulated product was not associated with significant improvement in HRQoL compared with the currently marketed Flolan as measured by the SF-36. However, most subjects preferred the reformulated product to the currently marketed Flolan. Moreover, the 2 formulations of Flolan had similar safety and efficacy profiles.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01462565","term_id":"NCT01462565"}}NCT01462565     

A Randomized,Single-Blind,Placebo-Controlled Study on the Efficacy of the Arthrokinematic Approach-Hakata Method in Patients with Chronic Nonspecific Low Back Pain

Study design

cized, single-blind, controlled trial.

Objective

To investigate the efficacy of the Arthrokinematic approach (AKA)-Hakata (H) method for chronic low back pain.

Summary of Background Data

The AKA-H method is used to manually treat abnormalities of intra-articular movement.

Methods

One hundred eighty-six patients with chronic nonspecific low back pain randomly received either the AKA-H method (AKA-H group) or the sham technique (S group) monthly for 6 months. Data were collected at baseline and once a month. Outcome measures were pain intensity (visual analogue scale [VAS]) and quality of life (the Roland-Morris Disability Questionnaire [RDQ] and Short Form SF-36 questionnaire [SF-36]).

Results

At baseline, the VAS, RDQ, and SF-36 scores showed similar levels between the groups. After 6 months, the AKA-H group had more improvement in the VAS (42.8% improvement) and RDQ score (31.1% improvement) than the sham group (VAS: 10.4% improvement; RDQ: 9.8% improvement; both, P < 0.001). The respective scores for the SF-36 subscales (physical functioning, role physical, bodily pain, social functioning, general health perception, role emotional, and mental health) were also significantly more improved in the AKA-H group than in the sham group (all, P < 0.001). The scores for the physical, psychological, and social aspects of the SF-36 subscales showed similar improvement in the AKA-H group.

Conclusion

The AKA-H method can be effective in managing chronic low back pain.

Trial Registration

UMIN Clinical Trials Registry (UMIN-CTR) UMIN000006250.     

Quality of Life after Diet or Exercise-Induced Weight Loss in Overweight to Obese Postmenopausal Women: The SHAPE-2 Randomised Controlled Trial

Introduction

This study investigates the effect of a modest weight loss either by a calorie restricted diet or mainly by increased physical exercise on health related quality of life (HRQoL) in overweight-to-obese and inactive postmenopausal women. We hypothesize that HRQoL improves with weight loss, and that exercise-induced weight loss is more effective for this than diet-induced weight loss.

Methods

The SHAPE-2 trial was primarily designed to evaluate any additional effect of weight loss by exercise compared with a comparable amount of weight loss by diet on biomarkers relevant for breast cancer risk. In the present analysis we focus on HRQoL. We randomly assigned 243 eligible women to a diet (n = 97), exercise (n = 98), or control group (n = 48). Both interventions aimed for 5–6 kg weight loss. HRQoL was measured at baseline and after 16 weeks by the SF-36 questionnaire.

Results

Data of 214 women were available for analysis. Weight loss was 4.9 kg (6.1%) and 5.5 kg (6.9%) with diet and exercise, respectively. Scores of the SF-36 domain ‘health change’ increased significantly by 8.8 points (95% CI 1.6;16.1) with diet, and by 20.5 points (95% CI 13.2;27.7) with exercise when compared with control. Direct comparison of diet and exercise showed a statistically significantly stronger improvement with exercise. Both intervention groups showed a tendency towards improvements in most other domains, which were more pronounced in the exercise group, but not statistically different from control or each other.

Conclusion

In a randomized trial in overweight-to-obese and inactive postmenopausal women a comparable 6%-7% weight loss was achieved by diet-only or mainly by exercise and showed improvements in physical and mental HRQoL domains, but results were not statistically significant in either the diet or exercise group. However, a modest weight loss does lead to a positive change in self-perceived health status. This effect was significantly larger with exercise-induced weight loss than with comparable diet-induced weight loss.

Trial Registration

ClinicalTrials.gov NCT01511276     

Chronic Stable Angina Is Associated with Lower Health-Related Quality of Life: Evidence from Chinese Patients

Objectives

To compare health-related quality of life (HRQoL) between patients with stable angina and the general population in China and to examine factors associated with HRQoL among patients with stable angina.

Methods

A cross-sectional HRQoL survey of stable angina patients recruited from 4 hospitals (n = 411) and the general population recruited from 3 Physical Examination Centers (n = 549) was conducted from July to December, 2011 in two large cities, Tianjin and Chengdu. HRQoL was assessed using the EQ-5D, EQ-VAS, and SF-6D instruments. The health status specific to patients with stable angina was assessed using the Seattle Angina Questionnaire (SAQ). Information on socio-demographic, clinical, and lifestyle factors were also collected. Nested regressions were performed to explore how these factors were associated with HRQoL in patients with stable angina.

Results

Compared with the general population (44.2±10 years, 49.9% females), stable angina patients (68.1±12 years, 50.4% females) had significantly lower HRQoL scores in EQ-5D utility index (0.75±0.19 vs. 0.90±0.20, p<0.05), SF-6D utility index (0.68±0.12 vs. 0.85±0.11, p<0.05), and EQ-VAS (71.2±12.3 vs. 83.9±10.9, p<0.05). The differences remained (−0.05 for EQ-5D, −9.27 for EQ-VAS and −0.13 for SF-6D) after controlling for socio-economic characteristics. SAQ scores showed that stable angina patients experienced impaired disease-specific health status, especially in angina stability (40.5±34.6). Nested regressions indicated stable angina-specific health status explained most of the variation in HRQoL, among which disease perception, physical limitation, and angina stability were the strongest predictors. More physical exercise and better sleep were positively related with HRQoL.

Conclusions

Compared to the general population, stable angina patients were associated with lower HRQoL and lower health utility scores, which were largely impacted by clinical symptoms. Further studies are needed to characterize the influence of geographic and cultural factors on the variations of health-related utility in stable angina patients.     

Association between Cardiorespiratory Fitness and Health-Related Quality of Life among Patients at Risk for Cardiovascular Disease in Uruguay

To date, few studies have examined the relationship between cardiorespiratory fitness (CRF) and health-related quality of life (HRQoL) in populations at high risk for developing cardiovascular disease (CVD).

Purpose

To examine the association between objectively measured CRF and physical and mental components of HRQoL in a Uruguayan cohort at risk for developing CVD.

Methods

Patient data records from 2002–2012 at the Calidad de Vida Center were examined. To assess CRF, participants performed a submaximal exercise test. During the evaluation, participants also completed the SF-36, a HRQoL measure comprised of eight dimensions that are summarized by physical and mental component scores (PCS and MCS, respectively). ANCOVA was used to examine the relationship between HRQoL dimensions and CRF. Logistic regression was then used to compare the odds of having a HRQoL component score above the norm across CRF. All analyses were performed separately for males and females with additional stratified analyses across age and BMI conducted among significant trends.

Results

A total of 2,302 subjects were included in the analysis. Among females, a significant relationship was observed between CRF and vitality, physical functioning, physical role, bodily pain, and general health dimensions. However, for males the only dimension found to be significantly associated with CRF was physical health. After adjusting for potential confounders, a significant linear trend (p<0.001) for PCS scores above the norm across CRF levels was observed for females only.

Conclusion

Among females with one or more risk factors for developing CVD, higher levels of CRF were positively associated with the vitality and physical dimensions of HRQoL, as well as the overall PCS. However, among males the only dimension associated with CRF was physical functioning. Future studies should examine this relationship among populations at risk for developing CVD in more detail and over time.     

Health-Related Quality of Life of Latin-American Immigrants and Spanish-Born Attended in Spanish Primary Health Care: Socio-Demographic and Psychosocial Factors

Background

This study compares the health-related quality of life of Spanish-born and Latin American-born individuals settled in Spain. Socio-demographic and psychosocial factors associated with health-related quality of life are analyzed.

Methods

A cross-sectional Primary Health Care multi center-based study of Latin American-born (n = 691) and Spanish-born (n = 903) outpatients from 15 Primary Health Care Centers (Madrid, Spain). The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess health-related quality of life. Socio-demographic, psychosocial, and specific migration data were also collected.

Results

Compared to Spanish-born participants, Latin American-born participants reported higher health-related quality of life in the physical functioning and vitality dimensions. Across the entire sample, Latin American-born participants, younger participants, men and those with high social support reported significantly higher levels of physical health. Men with higher social support and a higher income reported significantly higher mental health. When stratified by gender, data show that for men physical health was only positively associated with younger age. For women, in addition to age, social support and marital status were significantly related. Both men and women with higher social support and income had significantly better mental health. Finally, for immigrants, the physical and mental health components of health-related quality of life were not found to be significantly associated with any of the pre-migration factors or conditions of migration. Only the variable “exposure to political violence” was significantly associated with the mental health component (p = 0.014).

Conclusions

The key factors to understanding HRQoL among Latin American-born immigrants settled in Spain are age, sex and social support. Therefore, strategies to maintain optimal health outcomes in these immigrant communities should include public policies on social inclusion in the host society and focus on improving social support networks in order to foster and maintain the health and HRQoL of this group.     

A Comparison between the EQ-5D and the SF-6D in Patients with Chronic Obstructive Pulmonary Disease (COPD)

Background

The appropriate use of generic preference-based measures determines the accuracy of disease assessment and further decision on healthcare policy using quality adjusted life years. The discriminative capacity of different instruments would differ across disease groups. Our study was to examine the difference in utility scores for COPD patients measured by EQ-5D and SF-6D and to assist the choice of a proper instrument in this disease group.

Methods

Differences of mean utility scores of EQ-5D and SF-6D in groups defined by socio-demographic characteristics, comorbidities, health service utilisation and severity of illness were tested using Mann-Whitney test, t-test, Kruskal-Wallis test, Pearson’s correlation coefficient and ANOVA, as appropriate. The discriminative properties of the two instruments were compared against indicators of quality of life using receiver operating characteristic curves. The statistical significance of the area under the curves (AUC) was tested by ANOVA and F-statistics used to compare the efficiency with which each instrument discriminated between disease severity groups.

Results

Mean utility scores of EQ-5D and SF-6D were 0.644 and 0.629 respectively in the 154 subjects included in the analysis. EQ-5D scores were significantly higher than SF-6D in groups less severe and these differences corresponded to a minimally important difference of greater than 0.03 (p<0.001). EQ-5D and SF-6D scores were strongly correlated across the whole sample (r = 0.677, p<0.001) and in pre-defined groups (r>0.5 and p<0.05 for all correlation coefficients). AUCs were above 0.5 against the indicators of health-related quality of life for both instruments. F-ratios suggested SF-6D was more efficient in discriminating cases of different disease severity than EQ-5D.

Conclusions

Both EQ-5D and SF-6D appeared to be valid preference-based measures in Chinese COPD patients. SF-6D was more efficient in detecting differences among subgroups with differing health status. EQ-5D and SF-6D measured different things and might not be used interchangeably in COPD patients.     

Does Further Education in Adulthood Improve Physical and Mental Health among Australian Women? A Longitudinal Study

Objective

We analyzed whether further education in young adult and mid-life [adult educational mobility] influences physical functioning and depressive symptoms in women.

Methods

14247 women born 1973–78 (younger cohort) and 13715 women born 1946–51 (mid-aged cohort) from the Australian Longitudinal Study on Women’s Health were followed for 14–16 years. Measures were the Short-Form 36 Health Survey physical functioning subscale (SF-36 PF) and Centre for Epidemiologic Studies 10-item Depression Scale (CESD-10). Linear mixed modelling, accounting for time varying covariates, assessed the influence of further education on physical functioning and depressive symptoms over time. Sensitivity analysis to assess the impact of missing data was conducted using multiple imputation.

Results

Compared to younger women with a pre-existing high level of education, women gaining further education (up to age 39 years) from low levels had lower SF-36 PF scores (poorer physical functioning) (fully adjusted beta estimates (95%CIs) -1.52 (-2.59, -0.44)) while those gaining further education from middle to high levels showed equivalent SF-36 PF scores (-0.08 (-0.61, 0.44)). A similar pattern was shown for CESD-10 scores (0.78 (0.29, 1.25); -0.02 (-0.26, 0.21), respectively) where higher scores represented more depressive symptoms. For mid-age women, further education from a middle to high level resulted in equivalent SF-36 PF scores (-0.61 (-1.93,0.71)) but higher CESD-10 scores (0.49 (0.11, 0.86)), compared to highly educated women.

Conclusion

Women who delay further education until they are aged between their 40s and 60s can improve or maintain their physical functioning but may have missed the critical time to minimise depressive symptomatology. Public health policy should focus on encouraging women to upgrade their educational qualifications earlier in life in order to potentially offset the negative associations between their initial lower socio-economic position class of origin and their mental health.     

Rapid and sustained improvements in health-related quality of life,fatigue, and other patient-reported outcomes in rheumatoid arthritis patients treated with certolizumab pegol plus methotrexate over 1 year: results from the RAPID 1 randomized controlled trial

Introduction

The objective of this study was to assess the impact of certolizumab pegol (CZP) treatment on health-related quality of life (HRQoL), fatigue and other patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA).

Methods

Patients with active RA (N = 982) were randomized 2:2:1 to subcutaneous CZP (400 mg at weeks 0, 2 and 4; followed by CZP 200 mg or 400 mg) plus methotrexate (MTX) every other week, or placebo (PBO) plus MTX. PRO assessments included HRQoL, fatigue, physical function, arthritis pain and disease activity. Adjusted mean changes from baseline in all PROs were obtained using analysis of covariance (ANCOVA) applying last observation carried forward (LOCF) imputation. The proportion of patients achieving clinically meaningful improvements in each PRO was obtained using logistic regression and by applying non-responder imputation to missing values after rescue medication or withdrawal. The correlations between PRO responses and clinical responses were also assessed by tetrachoric correlation using non-responder imputation.

Results

Patients treated with CZP plus MTX reported significant (P < 0.001), clinically meaningful improvements in HRQoL at the first assessment (week 12); reductions in fatigue, disease activity and pain and improvements in physical function were reported at week 1. In particular, CZP-treated patients reported improvements in mental health. Mean changes from baseline in the SF-36 Mental Component Summary (MCS) at week 52 for CZP 200 mg and 400 mg plus MTX, and PBO plus MTX were 6.4, 6.4 and 2.1, respectively (P < 0.001). In addition, mental health and vitality scores in CZP-treated patients approached age- and gender-adjusted US population norms. Improvements in all PROs were sustained. Similar benefits were reported with both CZP doses. Changes in SF-36 MCS scores had the lowest correlation with disease activity scores (DAS28) and American College of Rheumatology 20% improvement (ACR20) response rates, while improvements in pain showed the highest correlation.

Conclusions

Treatment with CZP plus MTX resulted in rapid and sustained improvements in all PROs, indicating that the benefits of CZP extend beyond clinical efficacy endpoints into areas that are more relevant and meaningful for patients on a daily basis.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00152386","term_id":"NCT00152386"}}NCT00152386.     

Cardiovascular Complications Secondary to Graves’ Disease: A Prospective Study from Ukraine

Background

Graves’ disease (GD) is a common cause of hyperthyroidism resulting in development of thyrotoxic heart disease (THD).

Objectives

to assess cardiovascular disorders and health related quality of life (HRQoL) in patients with THD secondary to GD.

Patients and Methods

All patients diagnosed with THD secondary to GD between January 2011 and December 2013 were eligible for this study. Clinical assessment was performed at baseline and at the follow-up visit after the restoring of euthyroid state. HRQoL was studied with a questionnaire EQ-5D-5L.

Results

Follow-up data were available for 61 patients, but only 30 patients with THD secondary to GD were consented to participate in investigation of their HRQoL. The frequency of cardiovascular complications was significantly reduced as compared before and after the antithyroid therapy as follows: resting heart rate (122 vs. 74 bpm), blood pressure: systolic (155 vs. 123 mm Hg), diastolic (83 vs. 66 mm Hg), supraventricular premature contractions (71% vs. 7%), atrial fibrillation (72% vs. 25%), congestive heart failure (69% vs. 20%), thyrotoxic cardiomyopathy (77% vs. 26%), all p<0.01. Anti-TSH receptor antibodies were determined as independent predictor of left ventricular geometry changes, (b-coefficient = 0.04, 95%CI 0.01–0.07, p = 0.02). HRQoL was improved in all domains and self-rated health increased from 43 to 75 units by visual analogue score (p<0.001).

Conclusions

Restoring of euthyroid state in patients with GD is associated with significant elimination of cardiovascular disorders and improvement of HRQoL. To our knowledge this is the first study evaluating Ukrainian patients with THD secondary to GD with focus on HRQoL.     

Effect of a Medicinal Agaricus blazei Murill-Based Mushroom Extract,AndoSan?, on Symptoms,Fatigue and Quality of Life in Patients with Ulcerative Colitis in a Randomized Single-Blinded Placebo Controlled Study

Background

Ingestion of AndoSan^™, based on the mushroom Agaricus blazei Murill, has previously been shown to exhibit anti-inflammatory effects because of reduction of pro-inflammatory cytokines in healthy individuals and patients with ulcerative colitis. In this randomized single-blinded placebo controlled study we examined whether intake of AndoSan^™ also resulted in clinical effects.

Methods and Findings

50 patients with symptomatic ulcerative colitis were block-randomized and blinded for oral daily intake of AndoSan^™ or placebo for the 21 days’ experimental period. The patients reported scores for symptoms, fatigue and health related quality of life (HRQoL) at days 0, 14 and 21. Fecal calprotectin and general blood parameters were also analyzed. In the AndoSan^™ group (n = 24) symptoms improved from baseline (day 0) to days 14 and 21, with respective mean scores (95% CI) of 5.88 (4.92–6.83), 4.71 (3.90–5.52) (p = 0.002) and 4.50 (3.70–5.30) (p = 0.001). Corresponding improved mean scores (±SD) for total fatigue were 16.6 (5.59), 14.1 (4.50) (p = 0.001) and 15.1 (4.09) (p = 0.023). These scores in the placebo group (n = 26) were not improved. When comparing the two study groups using mixed model statistics, we found significant better scores for the AndoSan^™-patients. HRQoL for dimensions bodily pain, vitality, social functioning and mental health improved in the AndoSan^™ group. There were no alterations in general blood samples and fecal calprotectin.

Conclusions

Beneficiary effects on symptoms, fatigue and HRQoL from AndoSan^™ consumption were demonstrated in this per-protocol study, supporting its use as a supplement to conventional medication for patients with mild to moderate symptoms from ulcerative colitis. The patients did not report any harms or unintended effects of AndoSan^™ in this study.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01496053","term_id":"NCT01496053"}}NCT01496053     

Effectiveness and Cost-Effectiveness of Occupation-Based Occupational Therapy Using the Aid for Decision Making in Occupation Choice (ADOC) for Older Residents: Pilot Cluster Randomized Controlled Trial

Background

Care-home residents are mostly inactive, have little interaction with staff, and are dependent on staff to engage in daily occupations. We recently developed an iPad application called the Aid for Decision-making in Occupation Choice (ADOC) to promote shared decision-making in activities and occupation-based goal setting by choosing from illustrations describing daily activities. This study aimed to evaluate if interventions based on occupation-based goal setting using the ADOC could focus on meaningful activities to improve quality of life and independent activities of daily living, with greater cost-effectiveness than an impairment-based approach as well as to evaluate the feasibility of conducting a large cluster, randomized controlled trial.

Method

In this single (assessor)-blind pilot cluster randomized controlled trial, the intervention group (ADOC group) received occupational therapy based on occupation-based goal setting using the ADOC, and the interventions were focused on meaningful occupations. The control group underwent an impairment-based approach focused on restoring capacities, without goal setting tools. In both groups, the 20-minute individualized intervention sessions were conducted twice a week for 4 months.

Main Outcome Measures

Short Form-36 (SF-36) score, SF-6D utility score, quality adjusted life years (QALY), Barthel Index, and total care cost.

Results

We randomized and analyzed 12 facilities (44 participants, 18.5% drop-out rate), with 6 facilities each allocated to the ADOC (n = 23) and control (n = 21) groups. After the 4-month intervention, the ADOC group had a significantly greater change in the BI score, with improved scores (P = 0.027, 95% CI 0.41 to 6.87, intracluster correlation coefficient = 0.14). No other outcome was significantly different. The incremental cost-effectiveness ratio, calculated using the change in BI score, was $63.1.

Conclusion

The results suggest that occupational therapy using the ADOC for older residents might be effective and cost-effective. We also found that conducting an RCT in the occupational therapy setting is feasible.

Trial Registration

UMIN Clinical Trials Registry UMIN000012994     

Significant Effects of Oral Phenylbutyrate and Vitamin D3 Adjunctive Therapy in Pulmonary Tuberculosis: A Randomized Controlled Trial

Background

Development of new tuberculosis (TB) drugs and alternative treatment strategies are urgently required to control the global spread of TB. Previous results have shown that vitamin D₃ (vitD₃) and 4-phenyl butyrate (PBA) are potent inducers of the host defense peptide LL-37 that possess anti-mycobacterial effects.

Objective

To examine if oral adjunctive therapy with 5,000IU vitD₃ or 2x500 mg PBA or PBA+vitD₃ to standard chemotherapy would lead to enhanced recovery in sputum smear-positive pulmonary TB patients.

Methods

Adult TB patients (n = 288) were enrolled in a randomized, double-blind, placebo-controlled trial conducted in Bangladesh. Primary endpoints included proportions of patients with a negative sputum culture at week 4 and reduction in clinical symptoms at week 8. Clinical assessments and sputum smear microscopy were performed weekly up to week 4, fortnightly up to week 12 and at week 24; TB culture was performed at week 0, 4 and 8; concentrations of LL-37 in cells, 25-hydroxyvitamin D₃ (25(OH)D₃) in plasma and ex vivo bactericidal function of monocyte-derived macrophages (MDM) were determined at week 0, 4, 8, 12 and additionally at week 24 for plasma 25(OH)D₃.

Results

At week 4, 71% (46/65) of the patients in the PBA+vitD₃-group (p = 0.001) and 61.3% (38/62) in the vitD₃-group (p = 0.032) were culture negative compared to 42.2% (27/64) in the placebo-group. The odds of sputum culture being negative at week 4 was 3.42 times higher in the PBA+vitD₃-group (p = 0.001) and 2.2 times higher in vitD₃-group (p = 0.032) compared to placebo. The concentration of LL-37 in MDM was significantly higher in the PBA-group compared to placebo at week 12 (p = 0.034). Decline in intracellular Mtb growth in MDM was earlier in the PBA-group compared to placebo (log rank 11.38, p = 0.01).

Conclusion

Adjunct therapy with PBA+vitD₃ or vitD₃ or PBA to standard short-course therapy demonstrated beneficial effects towards clinical recovery and holds potential for host-directed-therapy in the treatment of TB.

Trial Registration

clinicaltrials.gov NCT01580007     

Undergoing Diagnostic Evaluation for Possible Cancer Affects the Health-Related Quality of Life in Patients Presenting with Non-Specific Symptoms

Aim

Undergoing diagnostic evaluation for possible cancer can affect health-related quality of life (HRQoL). The aims of this study were to examine the HRQoL in patients undergoing a diagnostic evaluation for possible cancer due to non-specific symptoms and further to investigate the impact of socio-demographic and medical factors associated with HRQoL at the time of diagnosis.

Methods

This was a prospective, multicenter survey study that included patients who were referred for a diagnostic evaluation due to non-specific cancer symptoms. Participants completed the EORTC-QLQ-C30 quality of life scale before and after completing the diagnostic evaluation. The baseline and follow-up EORTC-QLQ-C30 scores were compared with reference populations. The impact of socio-demographic and medical factors on HRQoL at follow-up was explored by bootstrapped multivariate linear regression.

Results

A total of 838 patients participated in the study; 680 (81%) also completed follow-up. Twenty-two percent of the patients received a cancer diagnosis at the end of follow-up. Patients presented initially with a high burden of symptoms, less role and emotional functioning and a lower global health/QoL. Most domains improved after diagnosis and no clinically important difference between baseline and follow-up scores was found. Patients reported effects on HRQoL both at baseline and at follow-up compared with the Danish reference population and had similar scores as a cancer reference population. Co-morbidity, being unemployed and receiving a cancer diagnosis had the greatest effect on HRQoL around the time of diagnosis.

Conclusions

Patients with non-specific symptoms reported an affected HRQoL while undergoing a diagnostic evaluation for possible cancer. Morbidity, being unemployed and receiving a cancer diagnosis had the greatest effect on HRQoL around the time of diagnosis.     

Increased Maternal and Cord Blood Betatrophin in Gestational Diabetes

Aim

The aim of the study was to compare maternal and cord blood levels of betatrophin – a new peptide potentially controlling beta cell growth - as well as in its mRNA expression in subcutaneous adipose tissue, visceral adipose tissue and placental tissue obtained from pregnant women with normal glucose tolerance (NGT) and gestational diabetes (GDM).

Methods

Serum betatrophin and irisin concentrations were measured by ELISA in 93 patients with GDM and 97 women with NGT between 24 and 28 week of gestation. Additionally, maternal and cord blood betatrophin and irisin, as well as their genes (C19orf80 and Fndc5) expression were evaluated in 20 patients with GDM and 20 women with NGT at term.

Results

In both groups, serum betatrophin concentrations were significantly higher in the patients with GDM than in the controls (1.91 [1.40-2.60] ng/ml vs 1.63 [1.21-2.22] ng/ml, p=0.03 and 3.45 [2.77-6.53] ng/ml vs 2.78 [2.16-3.65] ng/ml, p=0.03, respectively). Cord blood betatrophin levels were also higher in the GDM than in the NGT group (20.43 [12.97-28.80] ng/ml vs 15.06 [10.11-21.36] ng/ml, p=0.03). In both groups betatrophin concentrations in arterial cord blood were significantly higher than in maternal serum (p=0.0001). Serum irisin levels were significantly lower in the patients with GDM (1679 [1308-2171] ng/ml) than in the healthy women between 24 and 28 week of pregnancy (1880 [1519-2312] ng/ml, p=0.03). Both C19orf80 and Fndc5 mRNA expression in fat and placental tissue did not differ significantly between the groups studied.

Conclusions

Our results suggest that an increase in maternal and cord blood betatrophin might be a compensatory mechanism for enhanced insulin demand in GDM.     

Differences in Quality of Life,Anxiety and Depression in Patients with Paroxysmal Atrial Fibrillation and Common Forms of Atrioventricular Reentry Supraventricular Tachycardias

Introduction

The aim of this study was to evaluate the differences in quality of life and psychosocial stress parameters among patients with paroxysmal atrial fibrillation (AF) and common forms of atrioventricular reentry supraventricular tachycardias (SVTs).

Methods and Results

The total study population included 106 patients, 54 patients with paroxysmal AF (32 males, age 56.64±12.50 years) and 52 with SVTs (25 males, age 40.46±14.96 years). General health (p<0.01), physical function (p=0.004), role emotion (p=0.002) and role physical (p<0.01) scores were lower in patients who suffered AF. SF-36 physical and mental health summary measures were also significantly lower in the AF group compared to those in SVT group (p<0.01 and p=0.001, respectively). Lower SF-36 total score was observed in patients with AF compared to those with SVTs (p<0.01). Comparing the anxiety and depression scores all the values were higher in patients with AF. Higher STAI-state scores (p<0.01), STAI-trait scores (p=0.039) and BDI scores (p=0.077) were seen in patients who suffered AF comparing to those with SVTs.

Conclusions

Quality of life is significantly impaired and the level of anxiety is significantly higher in patients with AF comparing to those with common forms of SVTs.