Health-related quality of life in the patients on maintenance hemodialysis: the analysis of demographic and clinical factors

Health-related quality of life (HRQoL) among hemodialysis (HD) patients recently became a nephrologist's focus of interest. HRQoL is an important predictor of outcome in HD patients and need to be regularly assessed. The aim of the present study was to compare the HRQoL of chronic HD patients with general population and to analyze influencing sociodemographic and clinical factors. We included 255 prevalent HD patients from four dialysis centers. HRQoL was measured with The Medical Outcomes Study Short Form 36 Health Survey Questionnaire (SF-36). This data were compared with control group (N = 132) from the general Croatian population. Comparisons of SF-36 scale scores of HD patients regarding demographic and clinical factors (age, gender, education level, dialysis vintage and diabetes) were also performed and analyzed with a multivariate regression analysis. HRQoL in prevalent HD patients was relatively low (mean Physical Component Summary, PCS = 33.7, mean Mental Component Summary, MCS = 43.0) and was lower compared to the control group from the general population in all HRQoL domains, PCS and MCS scores. Almost 53% of the HD patients had the critical score PCS < 43 + MCS < 51 as the predictor of death and hospitalization. Better HRQoL was revealed in the patients < 65 years old, males, patients with higher educational level and in the patients on maintenance HD less than one year. Age was the only statistically significant predictor of PCS and MCS. Developments of HD technology, treatment of comorbidities, continuous patients' education, social and psychological support and use of other renal replacement modalities, especially kidney transplantation, may improve the HRQoL in these patients.     

Trigeminal Neurosensory Deficit and Patient Reported Outcome Measures: The Effect on Quality of Life

Objectives

To investigate the effect of persistent neurosensory disturbance of the lingual nerve (LN) or inferior alveolar nerve (IAN) on general health and oral health- related quality of life (QoL).

Methods

The study design was a case-control study. Patients with persistent neurosensory deficit of LN or IAN after lower third molar surgery (for 12 months or more) were the study group. The control group was an age and gender matched sample of patients who had dental extractions or lower third molar surgeries without trigeminal neurosensory deficit. The outcome variables were the general health and oral health-related QoL. General health-related QoL was assessed using the 36-item Short Form Health Survey (SF-36) and oral health-related QoL using the 14-item Short Form Oral Health Impact Profile (OHIP-14). Differences in SF-36 scores and OHIP-14 scores between the groups were compared.

Results

Forty-eight subjects (24 cases and 24 controls) were recruited. When compared to the control group, patients with neurosensory deficits had poorer Mental-Health Component Scores (MCS) (p = 0.005), General Health (p = 0.023), Vitality (p = 0.048), Social Functioning (p = 0.003), Role-emotion (p = 0.008) and Mental Health (p = 0.022). The OHIP-14 scores were also significantly worse in this patients with neurosensory deficits compared with the control group (p = 0.002). When compared within the study group, older patient with neurosensory deficit was found to correlate with worse Physical Health Component Scores (PCS) (p = 0.02) and OHIP-14 scores (p = 0.02), while more severe visualized analog scaling rating of numbness was correlated with a worse PCS (p = 0.034).

Conclusions

Patients with persistent LN or IAN deficit after lower third molar surgery have poorer health-related QoL and poorer oral health-related QoL than those without such deficits.     

Gender differences in diabetes mellitus and effectson self-care activity

Background:Effective self-care, including adherence to diet, exercise, and medication regimens, is an essential component of health care for individuals with diabetes mellitus (DM).Objective:The goals of this study were to examine sex-based differences in DM and to explore the effects of gender on self-care.Methods:This study was conducted retrospectively using data from the 2001 Medical Expenditure Panel Survey (MEPS). People with DM were identified by International Classification of Diseases, Ninth Revision, Clinical Modification diagnostic code; analyses were stratified by sex. Variables included age, race/ethnicity, education, income, body mass index (BMI), number of comorbidities, physical and cognitive limitations, smoking status, and depression. Outcome measures were assessed by Short Form-12 (SF-12) Mental Component Summary (MCS) and Physical Component Summary (PCS) scores. Univariate analyses were determined using t, χ², or Fisher exact tests, as appropriate. Multivariate analyses examined associations between sex and SF-12 MCS/PCS scores adjusted for other variables.Results:A total of 1653 MEPS respondents (883 women, 770 men) with DM were identified for the current study. The women were significantly older than the men (61.2 vs 59.1 years), had less education (11.1 vs 12.0 years), and had lower incomes. Women had higher calculated BMI (31.4 vs 30.3), more comorbidities (7.8 vs 6.4), more depression, and more physical and cognitive limitations than did men. Women also scored lower than men on the SF-12 MCS and PCS (47.8 vs 49.9 and 38.2 vs 41.4, respectively). All these measures were statistically significant (P < 0.01). In multivariate analyses, physical limitations, BMI, and number of comorbidities were negatively correlated, and income and education were positively correlated, with MCS and PCS scores.Conclusions:Compared with their male counterparts, diabetic women scored lower on measuresof health status and functioning—factors that are likely to affect self-care activities. Sex-based differences should be considered when developing screening and treatment programs for people with DM.     

Trunk rotational strength asymmetry in adolescents with idiopathic scoliosis: an observational study

Background

Body image and HRQL are significant issues for patients with scoliosis due to cosmetic deformity, physical and psychological symptoms, and treatment factors. A selective review of scoliosis literature revealed that self report measures of body image and HRQL share unreliable correlations with radiographic measures and clinician recommendations for surgery. However, current body image and HRQL measures do not indicate which aspects of scoliosis deformity are the most distressing for patients. The WRVAS is an instrument designed to evaluate patient self assessment of deformity, and may show some promise in identifying aspects of deformity most troubling to patients. Previous research on adolescents with scoliosis supports the use of the WRVAS as a clinical tool, as the instrument shares strong correlations with radiographic measures and quality of life instruments. There has been limited use of this instrument on adult populations.

Methods

The WRVAS and the SF-36v2, a HRQL measure, were administered to 71 adults with scoliosis, along with a form to report age and gender. Preliminary validation analyses were performed on the WRVAS (floor and ceiling effects, internal consistency and collinearity, correlations with the SF-36v2, and multiple regression with the WRVAS total score as the predictor, and SF-36v2 scores as outcomes).

Results

The psychometric properties of the WRVAS were acceptable. Older participants perceived their deformities as more severe than younger participants. More severe deformities were associated with lower scores on the Physical Component Summary Score of the SF-36v2. Total WRVAS score also predicted Physical Component Summary scores.

Conclusion

The results of the current study indicate that the WRVAS is a reliable tool to use with adult patients, and that patient self assessment of deformity shared a relationship with physical rather than psychological aspects of HRQL. The current and previous studies concur that revision of the WRVAS is necessary to more accurately represent the diversity of scoliosis deformities. Ability to identify disturbing aspects of deformity could potentially be improved by evaluating each WRVAS items against indicators of pain, physical/psychosocial function, and self image from previous measures such as the SRS, SF-36 or BSSQ-deformity.     

Measuring Surgical Outcomes in Cervical Spondylotic Myelopathy Patients Undergoing Anterior Cervical Discectomy and Fusion: Assessment of Minimum Clinically Important Difference

Object

The concept of minimum clinically important difference (MCID) has been used to measure the threshold by which the effect of a specific treatment can be considered clinically meaningful. MCID has previously been studied in surgical patients, however few studies have assessed its role in spinal surgery. The goal of this study was to assess the role of MCID in patients undergoing anterior cervical discectomy and fusion (ACDF) for cervical spondylotic myelopathy (CSM).

Methods

Data was collected on 30 patients who underwent ACDF for CSM between 2007 and 2012. Preoperative and 1-year postoperative Neck Disability Index (NDI), Visual-Analog Scale (VAS), and Short Form-36 (SF-36) Physical (PCS) and Mental (MCS) Component Summary PRO scores were collected. Five distribution- and anchor-based approaches were used to calculate MCID threshold values average change, change difference, receiver operating characteristic curve (ROC), minimum detectable change (MDC) and standard error of measurement (SEM). The Health Transition Item of the SF-36 (HTI) was used as an external anchor.

Results

Patients had a significant improvement in all mean physical PRO scores postoperatively (p<0.01) NDI (29.24 to 14.82), VAS (5.06 to 1.72), and PCS (36.98 to 44.22). The five MCID approaches yielded a range of values for each PRO: 2.00–8.78 for PCS, 2.06–5.73 for MCS, 4.83–13.39 for NDI, and 0.36–3.11 for VAS. PCS was the most representative PRO measure, presenting the greatest area under the ROC curve (0.94). MDC values were not affected by the choice of anchor and their threshold of improvement was statistically greater than the chance of error from unimproved patients.

Conclusion

SF-36 PCS was the most representative PRO measure. MDC appears to be the most appropriate MCID method. When MDC was applied together with HTI anchor, the MCID thresholds were: 13.39 for NDI, 3.11 for VAS, 5.56 for PCS and 5.73 for MCS.     

Health-Related Quality of Life in Patients with Nonfunctioning Pituitary Adenomas Undergoing Postoperative Radiation Therapy: A Case-Control Study

Objective: Nonfunctioning pituitary adenomas (NFPAs) can be associated with significant morbidity including a compromised quality of life (QoL). Radiotherapy (RT) is listed as one of the contributing factors to QoL impairment in these patients, however the evidence supporting this association is scarce and conflicting. Here we evaluate health-related QoL (HRQoL) impairment in patients with NFPA and to what extent this is due to RT.Methods: HRQoL was evaluated with the short form-36 questionnaire (SF-36), which explores 8 domains pertaining physical, emotional, and mental well being. We assessed 50 patients with NFPA subjected to RT after pituitary surgery, and their results were compared to those from 127 subjects who had undergone surgery but not RT. Both groups were matched for age, sex, and metabolic and cardiovascular comorbidities. The SF-36 was applied a median of 72 months after RT in the group of cases and 78 months after the last surgical procedure in the control group.Results: Both groups scored equally low in the 8 areas explored by the survey. In a multiple linear regression model, age was significantly associated with worse physical health scores, whereas female sex was associated with worse general health perception and lower emotional role and physical role scores. The presence of a visual field defect was significantly associated with a worse social role functioning score.Conclusion: QoL in patients with NFPAs is significantly compromised in most scales evaluated by the SF-36 survey. However, RT itself does not affect QoL.Abbreviations:CI = confidence intervalGH = growth hormoneHRQoL = health-related quality of lifeIQR = interquartile rangeNFPA = nonfunctioning pituitary adenomaQoL = quality of lifeRT = radiotherapySF-36 = short form 36-item health surveyTSS = transsphenoidal surgeryXRT = external beam radiotherapy     

Time Trends in Population Prevalence of Eating Disorder Behaviors and Their Relationship to Quality of Life

Objective

To examine temporal trends in the burden of eating disorder (ED) features, as estimated by the composite of their prevalence and impact upon quality of life (QoL) over a period of 10 years.

Methodology

Representative samples of 3010 participants in 1998 and 3034 participants in 2008 from the South Australian adult population were assessed for endorsement of ED features (objective binge eating, extreme dieting, and purging were assessed in both years; subjective binge eating and extreme weight/shape concerns were also assessed in 2008) and QoL using the Medical Outcomes Study Short Form (SF-36).

Principal Findings

From 1998 to 2008 significant increases in the prevalence of objective binge eating (2.7% to 4.9%, p<0.01) and extreme dieting (1.5% to 3.3%, p<0.01), but not purging, were observed. Lower scores on the SF-36 were significantly associated with endorsement of any of these behaviors in both 1998 and 2008 (all p<0.001). No significant difference was observed in the effect of the endorsement of these ED behaviors on QoL between 1998 and 2008 (all p>0.05). Multiple linear regressions found that in 1998 only objective binge eating significantly predicted scores on the mental health summary scale of the SF-36; however, in 2008 extreme weight/shape concerns, extreme dieting, and subjective binge eating were also significant predictors. Objective binge eating and extreme dieting were significant predictors of scores on the physical health summary scale of the SF-36 in both 1998 and 2008.

Conclusions and Significance

The prevalence of ED behaviors increased between 1998 and 2008, while their impact on QoL remained stable. This suggests an overall increase in the burden of disordered eating from 1998 to 2008. Given that binge eating and extreme dieting predict impairment in QoL, the necessity of interventions to prevent both under- and over-eating is reinforced.     

Factors related to health-related quality of life in ankylosing spondylitis,overall and stratified by sex

Background

Ankylosing spondylitis (AS) begins early in life and often leads to reduced physical function, but less is known about the impacts it has on health-related quality of life (HRQoL). The aims of this study were to assess HRQoL using the Short Form-36 (SF-36) in a cohort of patients with AS compared with controls and to examine associations between SF-36 scores and spinal radiographic changes, physical function, disease activity and demographic data overall and stratified by sex.

Methods

A cohort of patients with AS from Western Sweden were assessed using the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) with spinal radiographs, clinical examination and questionnaires, including the Bath Ankylosing Spondylitis Metrology Index, Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP), Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Patient Global (BASG) and SF-36. Each patient’s SF-36 results were compared with those of five age-matched and sex-matched persons (n?=?1055) from the SF-36 Swedish normative population database. Associations between SF-36 physical component summary (PCS) and mental component summary (MCS) scores and disease-related and demographic factors were investigated using univariate and multivariable ogistic regression analyses with PCS and MCS below/above their respective median values as dependent variables.

Results

A total of 210 patients, age (median, IQR) 49.0 (21.2) years, symptom duration 24.0 (21.0) years, men 57.6% and HLAB27 87.1% were included. Patients with AS scored significantly lower (p?<?0.001) compared to controls in all SF-36 domains and component summaries; PCS 42.4 (14.5) in AS versus 52.4 (11.8) in controls and MCS 47.9 (20.0) in AS versus 54.1 (10.1) in controls. Both men and women scored significantly lower in PCS compared with MCS. Multivariable logistic regression analyses revealed that living without a partner (OR 2.38, 95% CI 1.00–5.67), long symptom duration (year in decade OR 1.66, 95% CI 1.16–2.37), higher BASFI (OR 1.98, 95% CI 1.46–2.70) and ASDAS ≥?2.1 (OR 3.32, 95% CI 1.45–7.62) were associated with worse PCS, while living without a partner (OR 3.04, 95% CI 1.34–6.91), fatigue (visual analogue scale for global fatigue greater than the median (OR 6.36, 95% CI 3.06–13.19) and ASDAS ≥?2.1 (OR 2.97, 95% CI 1.41–6.25) with worse MCS. Some differences between sexes were observed in the results.

Conclusions

The patients with AS had significantly lower HRQoL compared with controls. PCS was more affected compared to MCS in both sexes. Both disease-related and demographic factors were associated with HRQoL, partly overlapping for PCS and MCS. Factors associated with HRQoL showed some differences between sexes. By modifying factors, such as ASDAS-CRP and fatigue, HRQoL may potentially be improved.

Trial registration

ClinicalTrials.gov, NCT00858819. Registered on 9 March 2009. Last updated on 28 May 2015.

     

Gout impacts on function and health-related quality of life beyond associated risk factors and medical conditions: results from the KING observational study of the Italian Society for Rheumatology (SIR)

Introduction

Gout is the most prevalent arthritis and significantly impacts on function and quality of life. Given that gout associates with disabling comorbid conditions, it is not clear whether such a complex of diseases accounts for the increased disability or if gout may play a role by itself. This study aims to evaluate the specific influence of gout and disease-related features on functional disability and health-related quality of life (HRQoL) in patients with gout followed in rheumatology clinics.

Methods

A random sample of patients was drawn from clinical registries of 30 rheumatology clinics across Italy. Sociodemographic, general health and gout-specific variables were collected. Functional disability and HRQoL were assessed by the health assessment questionnaire (HAQ) and the Physical and Mental Component Summary scores (PCS and MCS) of the Short Form-36 (SF-36). Crude and adjusted ordinal logistic and linear regression models were applied to investigate the specific contribution of different variables on HAQ and SF-36 scores. Results are presented as odds ratio (OR) or mean difference (MD) and 95% confidence intervals.

Results

Out of 446 patients with gout, 90% were males with a mean age of 63.9 years and median disease duration of 3.8 years; the majority of patients were overweight or obese, and with several comorbidities; 21.1% showed at least moderate disability; the PCS score was significantly lower than expected age- and gender-matched samples in the general population, while MCS score was not. After adjusting for potential sociodemographic and general-health confounders, gout-specific variables significantly impacted on HAQ, including polyarticular involvement OR 3.82 (1.63, 8.95), presence of tophi OR 1.92 (1.07, 3.43) and recent attacks OR 2.20 (1.27, 3.81). Consistent results were found for PCS. The impairment of PCS compared to the general population was limited to patients with features of chronic gout. MCS was only affected by recent attacks (MD -2.72 [-4.58, -0.86]) and corticosteroid treatment (-3.39 [-5.30,-1.48]).

Conclusions

The data from the KING study confirm that gout impacts on disability and provide evidence for an independent association of gout and gout-related features with functional outcome and HRQoL. This result supports the need to improve specific treatment in gout.     

Associations of Lifestyle Factors,Disease History and Awareness with Health-Related Quality of Life in a Thai Population

Background

The impact of the presence and awareness of individual health states on quality of life (HRQoL) is often documented. However, the impacts of different health states have rarely been compared amongst each other, whilst quality of life data from Asia are relatively sparse. We examined and compared the effects of different health states on quality of life in a Thai population.

Methods

In 2008–2009, 5,915 corporate employees were invited to participate in a survey where HRQoL was measured by the Short Form 36 (SF-36) questionnaire. The adjusted mean SF-36 scores were calculated for each self-reported illness, number of chronic conditions, lifestyle factors and awareness of diabetes and hypertension. The effect sizes (ES) were compared using Cohen''s d.

Results

The response rate was 82% and 4,683 (79.1%) had complete data available for analysis. Physical and Mental Component Summary (PCS and MCS) scores decreased as the number of chronic conditions increased monotonically (p<0.0001). Diabetes and hypertension negatively influenced PCS (mean score differences −0.6 and −1.5, p<0.001 respectively) but not MCS, whereas awareness of diabetes and hypertension negatively influenced MCS (−2.9 and −1.6, p<0.005 respectively) but not PCS. Arthritis had the largest ES on PCS (−0.37), while awareness of diabetes had the largest ES on MCS (−0.36). CVD moderately affected PCS and MCS (ES −0.34 and −0.27 respectively). Obesity had a negative effect on PCS (ES −0.27). Exercise positively affected PCS and MCS (ES +0.08 and +0.21 (p<0.01) respectively).

Conclusion

Health promotion to reduce the prevalence of chronic diseases is important to improve the quality of life in Asian populations. Physical activity is an important part of such programs. Awareness of diseases may have greater impacts on mental health than having the disease itself. This has implications for the evaluation of the cost-benefit of screening and labeling of individuals with pre-disease states.     

Anxiety and depression disorders in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension

Background

The objective of this prospective study was to assess the prevalence of anxiety and depression disorders and their association with quality of life (QoL), clinical parameters and survival in patients with pulmonary hypertension (PH).

Methods

We prospectively assessed 158 patients invasively diagnosed with pulmonary arterial hypertension (n = 138) and inoperable chronic thromboembolic PH (n = 20) by clinical measures including quality of life (QoL, SF-36 questionnaire), cardiopulmonary exercise testing and six minute walking distance and by questionnaires for depression (PHQ-9) and anxiety (GAD-7). According to the results of the clinical examination and the questionnaires for mental disorders (MD) patients were classified into two groups, 1) with moderate to severe MD (n = 36, 22,8%), and 2) with mild or no MD (n = 122). Patients were followed for a median of 2.7 years. Investigators of QoL, SF-36 were blinded to the clinical data.

Results

At baseline the 2 groups did not differ in their severity of PH or exercise capacity. Patients with moderate to severe MD (group 1) had a significantly lower QoL shown in all subscales of SF-36 (p < 0.002). QoL impairment significantly correlated with the severity of depression (p < 0.001) and anxiety (p < 0.05). During follow-up period 32 patients died and 3 were lost to follow-up. There was no significant difference between groups regarding survival. Only 8% of the patients with MD received psychopharmacological treatment.

Conclusion

Anxiety and depression were frequently diagnosed in our patients and significantly correlated with quality of life, but not with long term survival. Further prospective studies are needed to confirm the results.     

Aggrecanolysis and in vitro matrix degradation in the immature bovine meniscus: mechanisms and functional implications

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 NCT00152386.     

Psychometric Properties of the Problem Areas in Diabetes (PAID) Instrument in Singapore

Background

Emotional distress is an important dimension in diabetes, and several instruments have been developed to measure this aspect. The Problem Areas in Diabetes (PAID) scale is one such instrument which has demonstrated validity and reliability in Western populations, but its psychometric properties in Asian populations have not been examined.

Methods

This was a secondary analysis of data from patients with Type 2 diabetes mellitus recruited through convenience sampling from a diabetes specialist outpatient clinic in Singapore. The following psychometric properties were assessed: Construct validity through confirmatory factor analysis (CFA) and Rasch analysis, concurrent validity through correlation with related scales (Kessler Psychological Distress Scale, Diabetes Health Profile—psychological distress, Audit of Diabetes Dependent Quality of Life), reliability through assessment of internal consistency and floor and ceiling effects, and sensitivity by estimating effect sizes for known clinical and social functioning groups.

Results

203 patients with mean age of 45±12 years were analysed. None of the previously published model structures achieved a good fit on CFA. On Rasch analysis, four items showed poor fit and were removed. The abridged 16-item PAID mapped to a single latent trait, with a high degree of internal consistency (Cronbach ɑ 0.95), but significant floor effect (24.6% scoring at floor). Both 20-item and 16-item PAID scores were moderately correlated with scores of related scales, and sensitive to differences in clinical and social functioning groups, with large effect sizes for glycemic control and diabetes related complications, nephropathy and neuropathy.

Conclusion

The abridged 16-item PAID measures a single latent trait of emotional distress due to diabetes whereas the 20-item PAID appears to measures more than one latent trait. However, both the 16-item and 20-item PAID versions are valid, reliable and sensitive for use among Singaporean patients with diabetes.     

射频消融改善阵发性和长期持续性心房颤动患者生活质量的研究

目的:比较射频消融对阵发性和长期持续性心房颤动(房颤)患者生活质量的改善。方法:纳入2011年5月至2016年8月接受射频消融治疗的阵发性房颤患者142例和长期持续性房颤61例。消融前和消融后12个月采用健康状况调查简表(SF-36)评估患者生活质量。结果:长期持续性房颤患者年龄及合并高血压和慢性心功能不全的比例高于阵发性房颤组。消融后12个月,两组患者心理健康(MCS)和生理健康(PCS)评分均显著提高(P0.01)。长期持续性房颤患者MCS和PCS的改善幅度显著高于阵发性房颤组(P0.01)。房颤未复发患者生活质量的提高幅度显著高于复发患者(P0.01)。结论:射频消融改善长期持续性房颤患者生活质量的幅度高于阵发性房颤,房颤复发将影响患者的生活质量。     

Effect of Growth Hormone Replacement Therapy on the Quality of Life In Women with Growth Hormone Deficiency who Have A History of Acromegaly Versus Other Disorders

ObjectiveTo compare the response in quality of life (QoL) to growth hormone (GH) replacement in women with GH deficiency (GHD) and a history of acromegaly with that in women with GHD of other causes.MethodsFifty-five women with GHD were studied: 17 with prior acromegaly and 38 with other causes of GHD. We compared two 6-month, randomized, placebo controlled studies of GH therapy in women with hypopituitarism conducted with use of the same design—one in women with a history of acromegaly and one in women with no prior acromegaly. QoL was assessed with the following questionnaires: the QoL-Assessment of Growth Hormone Deficiency in Adults (AGHDA), the Symptom Questionnaire, and the 36-Item Short-Form Health Survey (SF-36).ResultsThe 2 groups had comparable mean pretreatment age, body mass index, and QoL scores and comparable mean GH dose at 6 months (0.61 ± 0.30 versus 0.67 ± 0.27 mg daily). After 6 months of GH replacement therapy, women with GHD and prior acromegaly demonstrated a greater improvement in AGHDA score, four SF-36 subscales (Role Limitations due to Physical Health, Energy or Fatigue, Emotional Well-Being, and Social Functioning), and the Somatic Symptoms subscale of the Symptom Questionnaire than did women with GHD of other causes. Poorer pretreatment QoL was associated with a greater improvement in QoL after administration of GH.ConclusionIn this study, GH replacement therapy improved QoL in women with GHD and a history of acromegaly but not in women with GHD due to other hypothalamic and pituitary disorders. Further studies are needed to determine the long-term risks versus benefits of GH replacement in patients who develop GHD after definitive treatment for acromegaly. (Endocr Pract. 2012;18:209-218)     

Psychometrics of the Short Form 36 Health Survey Version 2 (SF-36v2) and the Quality of Life Scale for Drug Addicts (QOL-DAv2.0) in Chinese Mainland Patients with Methadone Maintenance Treatment

Objective

To test psychometrics of the Short Form 36 Health Survey version 2 (SF-36v2) and the Quality of Life Scale for Drug Addicts (QOL-DAv2.0) in Chinese mainland patients with methadone maintenance treatment (MMT).

Methods

A total of 1,212 patients were recruited from two MMT clinics in Xi’an, China. Reliability was estimated with Cronbach’s α and intra-class correlation (ICC). Convergent and discriminant validity was assessed using multitrait-multimethod correlation matrix. Sensitivity was measured with ANOVA and relative efficiency. Responsiveness was evaluated by pre-post paired-samples t-test and standardized response mean based on the patients’ health status changes following 6-month period.

Results

Cronbach’s α of the SF-36v2 physical and mental summary components were 0.80 and 0.86 (eight scales range 0.73–0.92) and the QOL-DAv2.0 was 0.96 (four scales range: 0.80–0.93). ICC of the SF-36v2 two components were 0.86 and 0.85 (eight scales range: 0.72–0.87) and the QOL-DAv2.0 was 0.94 (four scales range: 0.88–0.92). Convergent validity was lower between the two instruments (γ <0.70) while discriminant validity was acceptable within each instrument. Sensitivity was satisfied in self-evaluated health status (both instruments) and average daily methadone dose (SF-36v2 physical functioning and vitality scales; QOL-DAv2.0 except psychology scale). Responsiveness was acceptable in the improved health status change (SF-36v2 except vitality scale; QOL-DAv2.0 except psychology and symptoms scales) and deteriorated health status change (SF-36v2 except vitality, social functioning and mental health scales; QOL-DAv2.0 except society scale).

Conclusions

The SF-36v2 and the QOL-DAv2.0 are valid tools and can be used independently or complementary according to different emphases of health-related quality of life evaluation in patients with MMT.     

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.     

Symptom burden and health-related quality of life in chronic kidney disease: A global systematic review and meta-analysis

BackgroundThe importance of patient-reported outcome measurement in chronic kidney disease (CKD) populations has been established. However, there remains a lack of research that has synthesised data around CKD-specific symptom and health-related quality of life (HRQOL) burden globally, to inform focused measurement of the most relevant patient-important information in a way that minimises patient burden. The aim of this review was to synthesise symptom prevalence/severity and HRQOL data across the following CKD clinical groups globally: (1) stage 1–5 and not on renal replacement therapy (RRT), (2) receiving dialysis, or (3) in receipt of a kidney transplant.Methods and findingsMEDLINE, PsycINFO, and CINAHL were searched for English-language cross-sectional/longitudinal studies reporting prevalence and/or severity of symptoms and/or HRQOL in CKD, published between January 2000 and September 2021, including adult patients with CKD, and measuring symptom prevalence/severity and/or HRQOL using a patient-reported outcome measure (PROM). Random effects meta-analyses were used to pool data, stratified by CKD group: not on RRT, receiving dialysis, or in receipt of a kidney transplant. Methodological quality of included studies was assessed using the Joanna Briggs Institute Critical Appraisal Checklist for Studies Reporting Prevalence Data, and an exploration of publication bias performed. The search identified 1,529 studies, of which 449, with 199,147 participants from 62 countries, were included in the analysis. Studies used 67 different symptom and HRQOL outcome measures, which provided data on 68 reported symptoms. Random effects meta-analyses highlighted the considerable symptom and HRQOL burden associated with CKD, with fatigue particularly prevalent, both in patients not on RRT (14 studies, 4,139 participants: 70%, 95% CI 60%–79%) and those receiving dialysis (21 studies, 2,943 participants: 70%, 95% CI 64%–76%). A number of symptoms were significantly (p < 0.05 after adjustment for multiple testing) less prevalent and/or less severe within the post-transplantation population, which may suggest attribution to CKD (fatigue, depression, itching, poor mobility, poor sleep, and dry mouth). Quality of life was commonly lower in patients on dialysis (36-Item Short Form Health Survey [SF-36] Mental Component Summary [MCS] 45.7 [95% CI 45.5–45.8]; SF-36 Physical Component Summary [PCS] 35.5 [95% CI 35.3–35.6]; 91 studies, 32,105 participants for MCS and PCS) than in other CKD populations (patients not on RRT: SF-36 MCS 66.6 [95% CI 66.5–66.6], p = 0.002; PCS 66.3 [95% CI 66.2–66.4], p = 0.002; 39 studies, 24,600 participants; transplant: MCS 50.0 [95% CI 49.9–50.1], p = 0.002; PCS 48.0 [95% CI 47.9–48.1], p = 0.002; 39 studies, 9,664 participants). Limitations of the analysis are the relatively few studies contributing to symptom severity estimates and inconsistent use of PROMs (different measures and time points) across the included literature, which hindered interpretation.ConclusionsThe main findings highlight the considerable symptom and HRQOL burden associated with CKD. The synthesis provides a detailed overview of the symptom/HRQOL profile across clinical groups, which may support healthcare professionals when discussing, measuring, and managing the potential treatment burden associated with CKD.Protocol registrationPROSPERO CRD42020164737.

In a systematic review and meta analysis, Benjamin R. Fletcher and colleagues study patient-reported symptom prevalence, severity, and health related quality of life among individuals with different stages of chronic kidney disease in 62 countries.     

Depression and subjective quality of life among outpatients with diabetes mellitus at a teaching hospital in Nigeria

Objective To determine the relationship between depression and the subjective assessment of quality of life (QoL) in a sample of patients with diabetes mellitus (DM) attending outpatient clinics at a regional university teaching hospital in Nigeria.Methods A cross-section of 200 patients were administered the depression module of the Schedule for the Clinical Assessment in Neuropsychiatry (SCAN) and the World Health Organization Quality of Life assessment - brief version (WHOQoL-Bref) over a two-month study period.Results A major depressive disorder (MDD) was diagnosed in 30% of patients. MDD was significantly associated with lower mean scores on the facets of overall QoL (p<0.01) and health satisfaction (p<0.01), but not in the domains of physical health (p=0.67), psychological health (p=0.59), environment (p=0.70), or social relations (p=0.58) of the WHOQoL-Bref.Conclusion Depression is associated with a poorer subjective assessment of QoL among DM patients in Nigeria.