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Showing papers on "Quality of life published in 2015"


Journal ArticleDOI
TL;DR: In four important domains of quality of life (QoL) (Chronic Respiratory Questionnaire (CRQ) scores for dyspnoea, fatigue, emotional function and mastery), the effect was larger than the minimal clinically important difference (MCID) of 0.4%.
Abstract: Background The widespread application pulmonary rehabilitation in chronic obstructive pulmonary disease (COPD) should be preceded by demonstrable improvements in function attributable to the programs. This review updates that reported by Lacasse et al Lancet 1996; 748:1115-1119. Objectives To determine the impact of rehabilitation on health-related quality of life (QoL) and exercise capacity in patients with COPD. Search strategy The 14 randomized controlled trials (RCTs) included in the original meta-analysis were included. Additional RCTs were identified from the Cochrane Airways Group's registry of COPD RCTs using the strategy: [exp, lung diseases, obstructive] and [exp, rehabilitation or exp, exercise therapy] and [research design or longitudinal studies or evaluation study or randomized controlled trial]. Abstracts presented at American Thoracic Society 1980-2000, American College of Chest Physicians 1980-2000 and European Respiratory Society 1987-2000 were also searched. Selection criteria RCTs of rehabilitation in patients with COPD in which quality of life (QoL) and/or functional (FEC) or maximal (MEC) exercise capacity were measured. Rehabilitation was defined as exercise training for at least 4 weeks with or without education and/or psychological support. Control groups received conventional community care without rehabilitation. Data collection and analysis Weighted mean differences (WMD) were calculated using a random-effects model. Missing data from the primary study reports were requested from the authors. Main results 23 RCTs met the inclusion criteria. Statistically significant improvements were found for all the outcomes. In three important domains of QoL (Chronic Respiratory Questionnaire scores for Dyspnea, Fatigue and Mastery), the effect was larger than the minimal clinically important difference of 0.5 units using this instrument. For example Dyspnoea score: WMD 0.98 units, 95% Confidence Interval (95% CI) 0.74 - 1.22 units; n=9 trials. For FEC and MEC, the effect was small and a little below the threshold of clinical significance for the 6- minute walking distance: WMD 49 m, 95% CI: 26 - 72 m; n=10 trials. Reviewer's conclusions Rehabilitation relieves dyspnea and fatigue and enhances patients' sense of control over their condition. These improvements are moderately large and clinically significant. The average improvement in exercise capacity was modest. Rehabilitation forms an important component of the management of COPD.

1,863 citations


Journal ArticleDOI
TL;DR: Early-entry participants' patient-reported outcomes and resource use were not statistically different; however, their survival 1-year after enrollment was improved compared with those who began 3 months later.
Abstract: Purpose Randomized controlled trials have supported integrated oncology and palliative care (PC); however, optimal timing has not been evaluated. We investigated the effect of early versus delayed PC on quality of life (QOL), symptom impact, mood, 1-year survival, and resource use. Patients and Methods Between October 2010 and March 2013, 207 patients with advanced cancer at a National Cancer Institute cancer center, a Veterans Affairs Medical Center, and community outreach clinics were randomly assigned to receive an in-person PC consultation, structured PC telehealth nurse coaching sessions (once per week for six sessions), and monthly follow-up either early after enrollment or 3 months later. Outcomes were QOL, symptom impact, mood, 1-year survival, and resource use (hospital/intensive care unit days, emergency room visits, chemotherapy in last 14 days, and death location). Results Overall patient-reported outcomes were not statistically significant after enrollment (QOL, P = .34; symptom impact, P = ....

840 citations


Journal ArticleDOI
TL;DR: To determine whether land-based therapeutic exercise is beneficial for people with knee OA in terms of reduced joint pain or improved physical function and quality of life, 54 studies were studied.
Abstract: Background Knee osteoarthritis (OA) is a major public health issue because it causes chronic pain, reduces physical function and diminishes quality of life. Ageing of the population and increased global prevalence of obesity are anticipated to dramatically increase the prevalence of knee OA and its associated impairments. No cure for knee OA is known, but exercise therapy is among the dominant non-pharmacological interventions recommended by international guidelines. Objectives To determine whether land-based therapeutic exercise is beneficial for people with knee OA in terms of reduced joint pain or improved physical function and quality of life. Search methods Five electronic databases were searched, up until May 2013. Selection criteria All randomised controlled trials (RCTs) randomly assigning individuals and comparing groups treated with some form of land-based therapeutic exercise (as opposed to exercise conducted in the water) with a non-exercise group or a non-treatment control group. Data collection and analysis Three teams of two review authors independently extracted data, assessed risk of bias for each study and assessed the quality of the body of evidence for each outcome using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach. We conducted analyses on continuous outcomes (pain, physical function and quality of life) immediately after treatment and on dichotomous outcomes (proportion of study withdrawals) at the end of the study; we also conducted analyses on the sustained effects of exercise on pain and function (two to six months, and longer than six months). Main results In total, we extracted data from 54 studies. Overall, 19 (20%) studies reported adequate random sequence generation and allocation concealment and adequately accounted for incomplete outcome data; we considered these studies to have an overall low risk of bias. Studies were largely free from selection bias, but research results may be vulnerable to performance and detection bias, as only four of the RCTs reported blinding of participants to treatment allocation, and, although most RCTs reported blinded outcome assessment, pain, physical function and quality of life were participant self-reported. High-quality evidence from 44 trials (3537 participants) indicates that exercise reduced pain (standardised mean difference (SMD) -0.49, 95% confidence interval (CI) -0.39 to -0.59) immediately after treatment. Pain was estimated at 44 points on a 0 to 100-point scale (0 indicated no pain) in the control group; exercise reduced pain by an equivalent of 12 points (95% CI 10 to 15 points). Moderate-quality evidence from 44 trials (3913 participants) showed that exercise improved physical function (SMD -0.52, 95% CI -0.39 to -0.64) immediately after treatment. Physical function was estimated at 38 points on a 0 to 100-point scale (0 indicated no loss of physical function) in the control group; exercise improved physical function by an equivalent of 10 points (95% CI 8 to 13 points). High-quality evidence from 13 studies (1073 participants) revealed that exercise improved quality of life (SMD 0.28, 95% CI 0.15 to 0.40) immediately after treatment. Quality of life was estimated at 43 points on a 0 to 100-point scale (100 indicated best quality of life) in the control group; exercise improved quality of life by an equivalent of 4 points (95% CI 2 to 5 points). High-quality evidence from 45 studies (4607 participants) showed a comparable likelihood of withdrawal from exercise allocation (event rate 14%) compared with the control group (event rate 15%), and this difference was not significant: odds ratio (OR) 0.93 (95% CI 0.75 to 1.15). Eight studies reported adverse events, all of which were related to increased knee or low back pain attributed to the exercise intervention provided. No study reported a serious adverse event. In addition, 12 included studies provided two to six-month post-treatment sustainability data on 1468 participants for knee pain and on 1279 (10 studies) participants for physical function. These studies indicated sustainability of treatment effect for pain (SMD -0.24, 95% CI -0.35 to -0.14), with an equivalent reduction of 6 (3 to 9) points on 0 to 100-point scale, and of physical function (SMD -0.15 95% CI -0.26 to -0.04), with an equivalent improvement of 3 (1 to 5) points on 0 to 100-point scale. Marked variability was noted across included studies among participants recruited, symptom duration, exercise interventions assessed and important aspects of study methodology. Individually delivered programmes tended to result in greater reductions in pain and improvements in physical function, compared to class-based exercise programmes or home-based programmes; however between-study heterogeneity was marked within the individually provided treatment delivery subgroup. Authors' conclusions High-quality evidence indicates that land-based therapeutic exercise provides short-term benefit that is sustained for at least two to six months after cessation of formal treatment in terms of reduced knee pain, and moderate-quality evidence shows improvement in physical function among people with knee OA. The magnitude of the treatment effect would be considered moderate (immediate) to small (two to six months) but comparable with estimates reported for non-steroidal anti-inflammatory drugs. Confidence intervals around demonstrated pooled results for pain reduction and improvement in physical function do not exclude a minimal clinically important treatment effect. Since the participants in most trials were aware of their treatment, this may have contributed to their improvement. Despite the lack of blinding we did not downgrade the quality of evidence for risk of performance or detection bias. This reflects our belief that further research in this area is unlikely to change the findings of our review.

701 citations


Journal ArticleDOI
TL;DR: The QOD in patients with end-stage cancer is not improved, and can be harmed, by chemotherapy use near death, even in Patients with good performance status, as a function of patients' performance status.
Abstract: Importance Although many patients with end-stage cancer are offered chemotherapy to improve quality of life (QOL), the association between chemotherapy and QOL amid progressive metastatic disease has not been well-studied. American Society for Clinical Oncology guidelines recommend palliative chemotherapy only for solid tumor patients with good performance status. Objective To evaluate the association between chemotherapy use and QOL near death (QOD) as a function of patients’ performance status. Design, Setting, and Participants A multi-institutional, longitudinal cohort study of patients with end-stage cancer recruited between September 2002 and February 2008. Chemotherapy use (n = 158 [50.6%]) and Eastern Cooperative Oncology Group (ECOG) performance status were assessed at baseline (median = 3.8 months before death) and patients with progressive metastatic cancer (N = 312) following at least 1 chemotherapy regimen were followed prospectively until death at 6 outpatient oncology clinics in the United States. Main Outcomes and Measures Patient QOD was determined using validated caregiver ratings of patients’ physical and mental distress in their final week. Results Chemotherapy use was not associated with patient survival controlling for clinical setting and patients’ performance status. Among patients with good (ECOG score = 1) baseline performance status, chemotherapy use compared with nonuse was associated with worse QOD (odds ratio [OR], 0.35; 95% CI, 0.17-0.75;P = .01). Baseline chemotherapy use was not associated with QOD among patients with moderate (ECOG score = 2) baseline performance status (OR, 1.06; 95% CI, 0.51-2.21;P = .87) or poor (ECOG score = 3) baseline performance status (OR, 1.34; 95% CI, 0.46-3.89;P = .59). Conclusions and Relevance Although palliative chemotherapy is used to improve QOL for patients with end-stage cancer, its use did not improve QOD for patients with moderate or poor performance status and worsened QOD for patients with good performance status. The QOD in patients with end-stage cancer is not improved, and can be harmed, by chemotherapy use near death, even in patients with good performance status.

420 citations


Journal ArticleDOI
TL;DR: It is suggested that stopping statin medication therapy is safe and may be associated with benefits including improved QOL, use of fewer nonstatin medications, and a corresponding reduction in medication costs.
Abstract: DESIGN, SETTING, AND PARTICIPANTS This was a multicenter, parallel-group, unblinded, pragmatic clinical trial. Eligibility included adults with an estimated life expectancy of between 1 month and 1 year, statin therapy for 3 months or more for primary or secondary prevention of cardiovascular disease, recent deterioration in functional status, and no recent active cardiovascular disease. Participants were randomized to either discontinue or continue statin therapy and were monitored monthly for up to 1 year. The study was conducted from June 3, 2011, to May 2, 2013. All analyses were performed using an intent-to-treat approach. INTERVENTIONS Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group. Patients in the continuation group continued to receive statins. MAIN OUTCOMES AND MEASURES Outcomes included death within 60 days (primary outcome), survival, cardiovascular events, performance status, quality of life (QOL), symptoms, number of nonstatin medications, and cost savings.

373 citations


Journal ArticleDOI
TL;DR: Early-group CGs had lower depression scores at 3 months and lower depression and stress burden in the terminal decline analysis, suggesting palliative care for CGs should be initiated as early as possible to maximize benefits.
Abstract: Purpose To determine the effect of early versus delayed initiation of a palliative care intervention for family caregivers (CGs) of patients with advanced cancer. Patients and Methods Between October 2010 and March 2013, CGs of patients with advanced cancer were randomly assigned to receive three structured weekly telephone coaching sessions, monthly follow-up, and a bereavement call either early after enrollment or 3 months later. CGs of patients with advanced cancer were recruited from a National Cancer Institute cancer center, a Veterans Administration Medical Center, and two community outreach clinics. Outcomes were quality of life (QOL), depression, and burden (objective, stress, and demand).

354 citations


Journal ArticleDOI
TL;DR: The LNG-IUS, compared with usual medical therapies, resulted in greater improvement over 2 years in women's assessments of the effect of HMB on their daily routine, including work, social and family life, and psychological and physical well-being.
Abstract: BACKGROUND: Heavy menstrual bleeding (HMB) is a common problem, yet evidence to inform decisions about initial medical treatment is limited. OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of the levonorgestrel-releasing intrauterine system (LNG-IUS) (Mirena(®), Bayer) compared with usual medical treatment, with exploration of women's perspectives on treatment. DESIGN: A pragmatic, multicentre randomised trial with an economic evaluation and a longitudinal qualitative study. SETTING: Women who presented in primary care. PARTICIPANTS: A total of 571 women with HMB. A purposeful sample of 27 women who were randomised or ineligible owing to treatment preference participated in semistructured face-to-face interviews around 2 and 12 months after commencing treatment. INTERVENTIONS: LNG-IUS or usual medical treatment (tranexamic acid, mefenamic acid, combined oestrogen-progestogen or progesterone alone). Women could subsequently swap or cease their allocated treatment. OUTCOME MEASURES: The primary outcome was the patient-reported score on the Menorrhagia Multi-Attribute Scale (MMAS) assessed over a 2-year period and then again at 5 years. Secondary outcomes included general quality of life (QoL), sexual activity, surgical intervention and safety. Data were analysed using iterative constant comparison. A state transition model-based cost-utility analysis was undertaken alongside the randomised trial. Quality-adjusted life-years (QALYs) were derived from the European Quality of Life-5 Dimensions (EQ-5D) and the Short Form questionnaire-6 Dimensions (SF-6D). The intention-to-treat analyses were reported as cost per QALY gained. Uncertainty was explored by conducting both deterministic and probabilistic sensitivity analyses. RESULTS: The MMAS total scores improved significantly in both groups at all time points, but were significantly greater for the LNG-IUS than for usual treatment [mean difference over 2 years was 13.4 points, 95% confidence interval (CI) 9.9 to 16.9 points; p < 0.001]. However, this difference between groups was reduced and no longer significant by 5 years (mean difference in scores 3.9 points, 95% CI -0.6 to 8.3 points; p = 0.09). By 5 years, only 47% of women had a LNG-IUS in place and 15% were still taking usual medical treatment. Five-year surgery rates were low, at 20%, and were similar, irrespective of initial treatments. There were no significant differences in serious adverse events between groups. Using the EQ-5D, at 2 years, the relative cost-effectiveness of the LNG-IUS compared with usual medical treatment was £1600 per QALY, which by 5 years was reduced to £114 per QALY. Using the SF-6D, usual medical treatment dominates the LNG-IUS. The qualitative findings show that women's experiences and expectations of medical treatments for HMB vary considerably and change over time. Women had high expectations of a prompt effect from medical treatments. CONCLUSIONS: The LNG-IUS, compared with usual medical therapies, resulted in greater improvement over 2 years in women's assessments of the effect of HMB on their daily routine, including work, social and family life, and psychological and physical well-being. At 5 years, the differences were no longer significant. A similar low proportion of women required surgical intervention in both groups. The LNG-IUS is cost-effective in both the short and medium term, using the method generally recommended by the National Institute for Health and Care Excellence. Using the alternative measures to value QoL will have a considerable impact on cost-effectiveness decisions. It will be important to explore the clinical and health-care trajectories of the ECLIPSE (clinical effectiveness and cost-effectiveness of levonorgestrel-releasing intrauterine system in primary care against standard treatment for menorrhagia) trial participants to 10 years, by which time half of the cohort will have reached menopause. TRIAL REGISTRATION: Current Controlled Trials ISRCTN86566246. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 88. See the NIHR Journals Library website for further project information.

325 citations


Journal ArticleDOI
TL;DR: Type D personality has an independent significant effect on the HRQoL in CAD patients with heart failure, and this relation is mediated by anxiety and depressive symptoms, social support.
Abstract: The relationship between Type D personality and health related quality of life (HRQoL) in coronary artery disease patients is becoming more established, however, the factors that may explain this association remain unclear. The objective of the study was to examine the mediating effects of mental distress and social support on the relationship between the Type D personality and HRQoL in CAD patients with heart failure. A total of 855 CAD patients with heart failure were assessed on Type D personality, mental distress, perceived social support and HRQoL with the following self-administered questionnaires: the Type D personality scale - 14, the Hospital Anxiety and Depression scale, the Multidimensional Scale of Perceived Social Support and the Minnesota Living with Heart Failure Questionnaire. The prevalence of Type D personality within the study population was 33.5%. Type D personality, anxiety symptoms, depressive symptoms and social support were all found to be determinants of decreased HRQoL (p’s < 0.001), once age, gender, NYHA functional class and acute myocardial infarction were adjusted for. Anxiety, depressive symptoms and social support were found to mediate the relationship between Type D personality and HRQoL. Type D personality exerted a stable effect on HRQoL over 24 months follow-up period. Type D personality has an independent significant effect on the HRQoL in CAD patients with heart failure, and this relation is mediated by anxiety and depressive symptoms, social support.

302 citations


Journal ArticleDOI
01 Feb 2015-Autism
TL;DR: The meta-analysis showed that quality of life is lower for people with autism compared to people without autism, and that the mean effect is large (Cohen’s d = −0.96), and the study concerning the elderly with autism showed that the difference in quality ofLife is similar in the elderly.
Abstract: Autism is a lifelong neurodevelopmental disorder, with a known impact on quality of life. Yet the developmental trajectory of quality of life is not well understood. First, the effect of age on quality of life was studied with a meta-analysis. Our meta-analysis included 10 studies (published between 2004 and 2012) with a combined sample size of 486 people with autism and 17,776 controls. Second, as there were no studies on quality of life of the elderly with autism, we conducted an empirical study on quality of life of the elderly (age range 53-83) with autism (N = 24) and without autism (N = 24). The meta-analysis showed that quality of life is lower for people with autism compared to people without autism, and that the mean effect is large (Cohen's d = -0.96). Age did not have an effect on quality of life. The study concerning the elderly with autism showed that the difference in quality of life is similar in the elderly. Age, IQ and symptom severity did not predict quality of life in this sample. Across the lifespan, people with autism experience a much lower quality of life compared to people without autism. Hence, the quality of life seemed to be independent of someone's age.

288 citations


Journal ArticleDOI
TL;DR: The prevalence of 1+ ADL limitation, poor self-rated health, and depression increased whereas quality of life declined markedly with an increase in number of diseases, highlighting the challenge of multimorbidity in LMICs, particularly among the lower socioeconomic groups.
Abstract: Chronic diseases contribute a large share of disease burden in low- and middle-income countries (LMICs). Chronic diseases have a tendency to occur simultaneously and where there are two or more such conditions, this is termed as ‘multimorbidity’. Multimorbidity is associated with adverse health outcomes, but limited research has been undertaken in LMICs. Therefore, this study examines the prevalence and correlates of multimorbidity as well as the associations between multimorbidity and self-rated health, activities of daily living (ADLs), quality of life, and depression across six LMICs. Data was obtained from the WHO’s Study on global AGEing and adult health (SAGE) Wave-1 (2007/10). This was a cross-sectional population based survey performed in LMICs, namely China, Ghana, India, Mexico, Russia, and South Africa, including 42,236 adults aged 18 years and older. Multimorbidity was measured as the simultaneous presence of two or more of eight chronic conditions including angina pectoris, arthritis, asthma, chronic lung disease, diabetes mellitus, hypertension, stroke, and vision impairment. Associations with four health outcomes were examined, namely ADL limitation, self-rated health, depression, and a quality of life index. Random-intercept multilevel regression models were used on pooled data from the six countries. The prevalence of morbidity and multimorbidity was 54.2 % and 21.9 %, respectively, in the pooled sample of six countries. Russia had the highest prevalence of multimorbidity (34.7 %) whereas China had the lowest (20.3 %). The likelihood of multimorbidity was higher in older age groups and was lower in those with higher socioeconomic status. In the pooled sample, the prevalence of 1+ ADL limitation was 14 %, depression 5.7 %, self-rated poor health 11.6 %, and mean quality of life score was 54.4. Substantial cross-country variations were seen in the four health outcome measures. The prevalence of 1+ ADL limitation, poor self-rated health, and depression increased whereas quality of life declined markedly with an increase in number of diseases. Findings highlight the challenge of multimorbidity in LMICs, particularly among the lower socioeconomic groups, and the pressing need for reorientation of health care resources considering the distribution of multimorbidity and its adverse effect on health outcomes.

279 citations


Journal ArticleDOI
TL;DR: Evaluated randomised controlled trials of the effectiveness of interventions aimed at enhancing RTW in cancer patients compared to alternative programmes including usual care or no intervention found low quality evidence that less radical, functioning conserving approaches had similar RTW rates as more radical treatments.
Abstract: Background Cancer patients are 1.4 times more likely to be unemployed than healthy people. Therefore it is important to provide cancer patients with programmes to support the return-to-work (RTW) process. This is an update of a Cochrane review first published in 2011. Objectives To evaluate the effectiveness of interventions aimed at enhancing RTW in cancer patients compared to alternative programmes including usual care or no intervention. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL, in the Cochrane Library Issue 3, 2014), MEDLINE (January 1966 to March 2014), EMBASE (January 1947 to March 2014), CINAHL (January 1983 to March, 2014), OSH-ROM and OSH Update (January 1960 to March, 2014), PsycINFO (January 1806 to 25 March 2014), DARE (January 1995 to March, 2014), ClinicalTrials.gov, Trialregister.nl and Controlled-trials.com up to 25 March 2014. We also examined the reference lists of included studies and selected reviews, and contacted authors of relevant studies. Selection criteria We included randomised controlled trials (RCTs) of the effectiveness of psycho-educational, vocational, physical, medical or multidisciplinary interventions enhancing RTW in cancer patients. The primary outcome was RTW measured as either RTW rate or sick leave duration measured at 12 months' follow-up. The secondary outcome was quality of life. Data collection and analysis Two review authors independently assessed trials for inclusion, assessed the risk of bias and extracted data. We pooled study results we judged to be clinically homogeneous in different comparisons reporting risk ratios (RRs) with 95% confidence intervals (CIs). We assessed the overall quality of the evidence for each comparison using the GRADE approach. Main results Fifteen RCTs including 1835 cancer patients met the inclusion criteria and because of multiple arms studies we included 19 evaluations. We judged six studies to have a high risk of bias and nine to have a low risk of bias. All included studies were conducted in high income countries and most studies were aimed at breast cancer patients (seven trials) or prostate cancer patients (two trials). Two studies involved psycho-educational interventions including patient education and teaching self-care behaviours. Results indicated low quality evidence of similar RTW rates for psycho-educational interventions compared to care as usual (RR 1.09, 95% CI 0.88 to 1.35, n = 260 patients) and low quality evidence that there is no difference in the effect of psycho-educational interventions compared to care as usual on quality of life (standardised mean difference (SMD) 0.05, 95% CI -0.2 to 0.3, n = 260 patients). We did not find any studies on vocational interventions. In one study breast cancer patients were offered a physical training programme. Low quality evidence suggested that physical training was not more effective than care as usual in improving RTW (RR 1.20, 95% CI 0.32 to 4.54, n = 28 patients) or quality of life (SMD -0.37, 95% CI -0.99 to 0.25, n = 41 patients). Seven RCTs assessed the effects of a medical intervention on RTW. In all studies a less radical or functioning conserving medical intervention was compared with a more radical treatment. We found low quality evidence that less radical, functioning conserving approaches had similar RTW rates as more radical treatments (RR 1.04, 95% CI 0.96 to 1.09, n = 1097 patients) and moderate quality evidence of no differences in quality of life outcomes (SMD 0.10, 95% CI -0.04 to 0.23, n = 1028 patients). Five RCTs involved multidisciplinary interventions in which vocational counselling, patient education, patient counselling, biofeedback-assisted behavioral training and/or physical exercises were combined. Moderate quality evidence showed that multidisciplinary interventions involving physical, psycho-educational and/or vocational components led to higher RTW rates than care as usual (RR 1.11, 95% CI 1.03 to 1.16, n = 450 patients). We found no differences in the effect of multidisciplinary interventions compared to care as usual on quality of life outcomes (SMD 0.03, 95% CI -0.20 to 0.25, n = 316 patients). Authors' conclusions We found moderate quality evidence that multidisciplinary interventions enhance the RTW of patients with cancer.

Journal ArticleDOI
TL;DR: This is the first study to examine physical and mental health QOL, as an indicator of successful aging, among LGBT older adults, and important differences by age group emerged.
Abstract: Purpose: Lesbian, g ay, bisexual, and transgender (LGBT) people are a health disparate population as identified in Healthy People 2020. Yet, there has been limited attention to how LGBT older adults maintain successful aging despite the adversity they face. Utilizing a Resilience Framework, this study investigates the relationship between physical and mental health-related quality of life (QOL) and covariates by age group. Design and Methods: A cross-sectional survey of LGBT adults aged 50 and older (N = 2,560) was conducted by Caring and Aging with Pride: The National Health, Aging, and Sexuality Study via collaborations with 11 sites across the U.S. Linear regression analyses tested specified relationships and moderating effects of age groups (aged 50–64; 65–79; 80 and older). Results: Physical and mental health QOL were neg atively associated with discrimination and chronic conditions and positively with social support, social network size, physical and leisure activities, substance nonuse, employment, income, and being male when controlling for age and other covariates. Mental health QOL was also positively associated with positive sense of sexual identity and negatively with sexual identity disclosure. Important differences by age group emerged and for the old–old age group the influence of discrimination was particularly salient. Implications: This is the first study to examine ph ysical and mental health QOL, as an indicator of successful aging, among LGBT older adults. An understanding of the configuration of resources and risks by age group is important for the development of aging and health initiatives tailored for this growing population.

Journal ArticleDOI
TL;DR: The states of science on the survivorship experience of cancer survivors and caregivers are reviewed, with a focus on symptom burden and quality of life (QOL) after treatment termination, indicated residual symptoms that extend into survivorship have a great impact on QOL and are associated with disability and healthcare utilization.
Abstract: Background Cancer has a great impact on the well-being of affected persons and their caregivers long into survivorship. Objective This article reviews the state of science on the survivorship experience of cancer survivors and caregivers, with a focus on symptom burden and quality of life (QOL) after treatment termination. Methods The primary databases utilized included PubMed and CINAHL. Search results were limited to human participants, English language, and publications from 2008 to 2013. The articles retrieved included studies of prostate, breast, colorectal, and gynecologic cancers during adulthood. Results As many as a third of cancer survivors experienced symptoms after treatment cessation equivalent to those experienced during treatment. Fatigue, depression or mood disturbance, sleep disruption, pain, and cognitive limitation were commonly reported by survivors across various malignancies; depression, anxiety, and sleep disturbance affected some caregivers. The studies indicated residual symptoms that extend into survivorship have a great impact on QOL and are associated with disability and healthcare utilization. Younger age, lower socioeconomic status, and increased comorbidities are associated with poorer QOL and higher symptom distress in cancer survivors. Younger age and lower income are associated with greater distress and poorer QOL in caregivers. Conclusions Survivors and caregivers struggle with symptom burden and diminished QOL long into survivorship. Longitudinal studies are needed to investigate the persistence and severity of symptom burden over time as well as long-term and late effects of these symptoms. Implications for practice Interventions designed to help alleviate symptom burden in those most affected are needed.

Journal ArticleDOI
TL;DR: In this paper, the authors evaluated the effect of increasing physical and nutritional rehabilitation plus information delivered during the post-intensive care unit (ICU) acute hospital stay by dedicated rehabilitation assistants on subsequent mobility, HRQOL, and prevalent disabilities.
Abstract: Importance Critical illness results in disability and reduced health-related quality of life (HRQOL), but the optimum timing and components of rehabilitation are uncertain. Objective To evaluate the effect of increasing physical and nutritional rehabilitation plus information delivered during the post–intensive care unit (ICU) acute hospital stay by dedicated rehabilitation assistants on subsequent mobility, HRQOL, and prevalent disabilities. Design, Setting, and Participants A parallel group, randomized clinical trial with blinded outcome assessment at 2 hospitals in Edinburgh, Scotland, of 240 patients discharged from the ICU between December 1, 2010, and January 31, 2013, who required at least 48 hours of mechanical ventilation. Analysis for the primary outcome and other 3-month outcomes was performed between June and August 2013; for the 6- and 12-month outcomes and the health economic evaluation, between March and April 2014. Interventions During the post-ICU hospital stay, both groups received physiotherapy and dietetic, occupational, and speech/language therapy, but patients in the intervention group received rehabilitation that typically increased the frequency of mobility and exercise therapies 2- to 3-fold, increased dietetic assessment and treatment, used individualized goal setting, and provided greater illness-specific information. Intervention group therapy was coordinated and delivered by a dedicated rehabilitation practitioner. Main Outcomes and Measures The Rivermead Mobility Index (RMI) (range 0-15) at 3 months; higher scores indicate greater mobility. Secondary outcomes included HRQOL, psychological outcomes, self-reported symptoms, patient experience, and cost-effectiveness during a 12-month follow-up (completed in February 2014). Results Median RMI at randomization was 3 (interquartile range [IQR], 1-6) and at 3 months was 13 (IQR, 10-14) for the intervention and usual care groups (mean difference, −0.2 [95% CI, −1.3 to 0.9; P = .71]). The HRQOL scores were unchanged by the intervention (mean difference in the Physical Component Summary score, −0.1 [95% CI, −3.3 to 3.1; P = .96]; and in the Mental Component Summary score, 0.2 [95% CI, −3.4 to 3.8; P = .91]). No differences were found for self-reported symptoms of fatigue, pain, appetite, joint stiffness, or breathlessness. Levels of anxiety, depression, and posttraumatic stress were similar, as were hand grip strength and the timed Up & Go test. No differences were found at the 6- or 12-month follow-up for any outcome measures. However, patients in the intervention group reported greater satisfaction with physiotherapy, nutritional support, coordination of care, and information provision. Conclusions and Relevance Post-ICU hospital-based rehabilitation, including increased physical and nutritional therapy plus information provision, did not improve physical recovery or HRQOL, but improved patient satisfaction with many aspects of recovery. Trial Registration isrctn.com Identifier:ISRCTN09412438

Journal ArticleDOI
TL;DR: The results indicate that the high-risk state is characterised by consistent and large impairments of functioning and reduction in QoL similar to those in other coded psychiatric disorders.
Abstract: Background The nosology of the psychosis high-risk state is controversial. Traditionally conceived as an ‘at risk’ state for the development of psychotic disorders, it is also conceptualised as a clinical syndrome associated with functional impairment. Aims To investigate meta-analytically the functional status of patients at high clinical risk for psychosis and its association with longitudinal outcomes. Method Three meta-analyses compared level of functioning ( n = 3012) and quality of life (QoL) ( n = 945) between a high-risk group, a healthy control group and group with psychosis, and baseline functioning in people in the high-risk group who did or did not have a transition to psychosis at follow-up ( n = 654). Results People at high risk had a large impairment in functioning ( P <0.001) and worse QoL ( P = 0.001) than the healthy control group, but only small to moderately better functioning ( P = 0.012) and similar QoL ( P = 0.958) compared with the psychosis group. Among the high-risk group, those who did not develop psychosis reported better functioning ( P = 0.001) than those who did. Conclusions Our results indicate that the high-risk state is characterised by consistent and large impairments of functioning and reduction in QoL similar to those in other coded psychiatric disorders.

Journal ArticleDOI
TL;DR: An inpatient PC model for patients with acute HF is associated with short-term improvement in symptom burden, QOL, and depressive symptoms.
Abstract: Background: Heart failure (HF) is associated with a high symptom burden and reduced quality of life (QOL). Models integrating palliative care (PC) into HF care have been proposed, but limited research is available on the outcomes of such models. Objective: Our aim was to assess if inpatient PC for HF patients is associated with improvements in symptom burden, depressive symptoms, QOL, or differential use of services. Methods: Patients hospitalized with acute HF were randomized to receive a PC consult with follow-up as determined by provider or standard care. Two hundred thirty-two patients (116 intervention/116 control) from a large tertiary-care urban hospital were recruited over a 10-month period. Primary outcomes were symptom burden, depressive symptoms, and QOL measured at baseline, 1, and 3 months. Secondary outcomes included advance care planning (ACP), inpatient 30-day readmission, hospice use, and death. Results: Improvements were greater at both 1 and 3 months in the intervention group f...

Journal ArticleDOI
TL;DR: The need for AYA-specific programs in health care institutions that comprise a multidisciplinary team that addresses all the unique medical and QoL needs of AYAs is suggested, indicating a trend toward health care standardization within age ranges or life stages.
Abstract: Introduction Adolescent and young adult (AYA) cancer survivors experience many unique challenges and quality of life (QoL) effects that persist beyond cancer diagnosis and treatment. Due to continuous improvements in technology and cancer treatments resulting in improved survival rates, the identification of late effects, survivorship issues, and QoL is moving to the forefront of cancer research. The goal of this systematic review was to identify key psychosocial factors impacting QoL in AYA oncology populations. Methods A systematic review of the literature was conducted using combinations of these phrases or keywords: "adolescent and young adult or AYA" AND "health outcomes OR quality of life OR psychology" AND "neoplasm OR cancer OR oncology". A total of 35 articles were included in this review. Studies were classified into two categories: AYA perceptions and stakeholder perceptions. Results AYA cancer survivors were more likely to have "worse" or impaired QoL compared with the general population, regardless of other demographic factors. AYAs described both positive and negatives experiences with their medical care, the educational information received, and the supportive care services. Although health care professionals were likely to underestimate or misjudge the health preferences and support needs of AYAs, these perceptions varied across disciplines and levels of experience. Conclusion The literature is lacking in sufficient evidence-based interventions to improve QoL in AYA cancer populations. Further, the tools to adequately measure QoL in this population are also unsatisfactory. The literature, however, consistently shows agreement regarding the unique needs of this population, indicating a trend toward health care standardization within age ranges or life stages. We suggest the need for AYA-specific programs in health care institutions that comprise a multidisciplinary team that addresses all the unique medical and QoL needs of AYAs.

Journal ArticleDOI
TL;DR: In this article, the authors investigated whether resistance exercise during chemotherapy provides benefits on fatigue and quality of life (QoL) beyond potential psychosocial effects of group-based interventions, and they found that resistance exercise appeared to mitigate physical fatigue and maintain QoL during chemotherapy beyond psychossocial effects inherent to supervised, groupbased settings.
Abstract: Multiple exercise interventions have shown beneficial effects on fatigue and quality of life (QoL) in cancer patients, but various psychosocial interventions as well. It is unclear to what extent the observed effects of exercise interventions are based on physical adaptations or rather on psychosocial factors associated with supervised, group-based programs. It needs to be determined which aspects of exercise programs are truly effective. Therefore, we aimed to investigate whether resistance exercise during chemotherapy provides benefits on fatigue and QoL beyond potential psychosocial effects of group-based interventions. One-hundred-one breast cancer patients starting chemotherapy were randomly assigned to resistance exercise (EX) or a relaxation control (RC) group. Both interventions were supervised, group-based, 2/week over 12 weeks. The primary endpoint fatigue was assessed with a 20-item multidimensional questionnaire, QoL with the EORTC QLQ-C30/BR23. Analyses of covariance for individual changes from baseline to Week 13 were calculated. In RC, total and physical fatigue worsened during chemotherapy, whereas EX showed no such impairments (between-group p = 0.098 and 0.052 overall, and p = 0.038 and 0.034 among patients without severe baseline depression). Differences regarding affective or cognitive fatigue were not significant. Benefits of EX were also seen to affect role and social function. Effect sizes were between 0.43 and 0.48. Explorative analyses indicated significant effect modification by thyroxin use (p-interaction = 0.044). In conclusion, resistance exercise appeared to mitigate physical fatigue and maintain QoL during chemotherapy beyond psychosocial effects inherent to supervised group-based settings. Thus, resistance exercise could be an integral part of supportive care for breast cancer patients undergoing chemotherapy.

Journal ArticleDOI
01 Mar 2015-Ejso
TL;DR: Self-perception of body image seems to be more important for QoL after breast cancer surgery than social and role functioning, fatigue, pain, body image, and arm symptoms, and among BCS and TMIR patients, objectively measured cosmetic results did not affect generalQoL.
Abstract: Purpose Studies regarding the effects of aesthetic outcomes after breast cancer surgery on quality of life (QoL) have yielded inconsistent results. This study analyzed the aesthetic outcomes and QoL of women who underwent breast conserving surgery (BCS) or total mastectomy with immediate reconstruction (TMIR) using objective and validated methods. Patients and methods QoL questionnaires (EORTC QLQ-C30, BR23, and HADs) were administered at least 1 year after surgery and adjuvant therapy to 485 patients who underwent BCS, 46 who underwent TMIR, and 87 who underwent total mastectomy (TM) without reconstruction. Aesthetic results were evaluated using BCCT.core software and by a panel of physicians. Patients' body image perception was assessed using the body image scale (BIS). Results QoL outcomes, including for social and role functioning, fatigue, pain, body image, and arm symptoms, were significantly better in the BCS and TMIR groups than in the TM group (p Conclusion In conclusion, BCS and TMIR enhanced QoL compared with TM. Among BCS and TMIR patients, objectively measured cosmetic results did not affect general QoL. S elf-perception of body image seems to be more important for QoL after breast cancer surgery.

Journal ArticleDOI
TL;DR: The lack of consensus on measuring QoL in dementia suggests a need for a broader, more rigorously tested QoG measure, which is likely to be based on rigorous conceptual frameworks.
Abstract: Objectives: Ascertaining the quality of life (QoL) in people with dementia is important for evaluating service outcomes and cost-effectiveness. This paper identifies QoL measures for people with dementia and assesses their properties.Method: A systematic narrative review identified articles using dementia QoL measures. Electronic databases searched were AMED, CINAHL, EMBASE, Index to Theses, IBSS, MEDLINE, PsycINFO, Sociological Abstracts, and Web of Science. All available years and languages (if with an English language abstract) were included.Results: Searches yielded 6806 citations; 3043 were multiple duplicates (759 being true duplicates). Abstracts were read; 182 full papers were selected/obtained, of which 126 were included as relevant. Few measures were based on rigorous conceptual frameworks. Some referenced Lawton's model (Dementia Quality of Life [DQOL] and Quality of Life in Alzheimer's Disease [QOL-AD]), though these tapped part of this only; others claimed relationship to a health-related QoL...

Journal ArticleDOI
TL;DR: Total knee replacement confers significant intermediate and long-term benefits with respect to both disease-specific and generic health-related quality of life, especially pain and function, leading to positive patient satisfaction.
Abstract: BACKGROUND: Total knee replacement is a highly successful and frequently performed operation. Technical outcomes of surgery are excellent, with favorable early postoperative health-related quality of life. This study reviews intermediate and long-term quality of life after surgery. METHODS: A systematic review and meta-analysis of all studies published from January 2000 onward was performed to evaluate health-related quality of life after primary total knee replacement for osteoarthritis in patients with at least three years of follow-up. Key outcomes were postoperative quality of life, function, and satisfaction compared with the preoperative status. Strict inclusion and exclusion criteria were applied. Quality appraisal and data tabulation were performed with use of predefined criteria. Data were synthesized by narrative review and random-effects meta-analysis utilizing standardized mean differences. Heterogeneity was assessed with the tau(2) and I(2) statistics. RESULTS: Nineteen studies were included in the review. Intermediate and long-term postoperative quality of life was superior to the preoperative level in qualitative and quantitative analyses. The pooled effect in combined WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) and KSS (Knee Society Score) outcomes was a marked improvement from baseline with respect to the total score (2.17; 95% CI [confidence interval], 1.13 to 3.22; p < 0.0001) and the pain (1.72; 95% CI, 0.97 to 2.46; p < 0.00001) and function (1.26; 95% CI, 0.87 to 1.64; p < 0.00001) domains. Most patients were satisfied with the surgery and derived substantial benefits for daily functional activities. Tau(2) (0.20 to 1.10) and I(2) (90% to 98%) values implied significant clinical and statistical heterogeneity. CONCLUSIONS: Total knee replacement confers significant intermediate and long-term benefits with respect to both disease-specific and generic health-related quality of life, especially pain and function, leading to positive patient satisfaction. Recommendations for necessary future studies are provided. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

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TL;DR: Nutritional risk is significant in acutely ill medical inpatients and is associated with increased medical resource use, adverse clinical outcomes, and impairments in functional ability and QoL.

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TL;DR: In this paper, the authors compare health-related quality of life (HRQOL) in pediatric patients with functional gastrointestinal disorders (FGIDs) and organic gastrointestinal (GI) diseases with an age-, sex-, and race/ethnicity-matched healthy sample across GI diagnostic groups and with one another.

01 Jan 2015
TL;DR: Neurofibromatosis type 1 has a significant impact on QoL through alteration of health and appearance and the consequences of visibility and severity from the viewpoint of patients can be evaluated using Skindex and the SF-36, respectively.
Abstract: Background: Neurofibromatosis type 1 affects quality of life (QoL) through association with severe complications, impact on cosmetic features, and uncertainty of the effects of the disorder. Objective: To evaluate the impact of the severity and visibility of neurofibromatosis type 1 on QoL. Design: Monocenter, cross-sectional study. Setting: One French academic dermatological and neurofibromatoses clinic. Patients: A total of 128 adult patients with neurofibromatosis type 1.

Journal ArticleDOI
TL;DR: Evaluating the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues found low quality evidence of rigid bracing compared with observation.
Abstract: Background Idiopathic scoliosis is a three-dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Objectives To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. Search methods We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. Selection criteria Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. Data collection and analysis We used standard methodological procedures expected by The Cochrane Collaboration. Main results We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) -2.10, 95% confidence interval (CI) -7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow-up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow-up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow-up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow-up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention-to-treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow-up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Authors' conclusions Due to the important clinical differences among the studies, it was not possible to perform a meta-analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise-based' trials, prospective controlled cohort studies, prospective studies conducted according to pre-defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing.

Journal ArticleDOI
TL;DR: The extent of obesity predicted depressive symptoms and low HRQOL and in contrast to population-based studies, sex, age, pubertal status and family history of depression did not predict depressive symptoms.

Journal ArticleDOI
01 Jun 2015-Cancer
TL;DR: This 8‐ to 15‐year follow‐up of a previously conducted trial (NCT01422551) evaluated whether women in this cohort receiving CBSM had fewer depressive symptoms and better QOL than controls at an 8- to 15-year follow-up.
Abstract: BACKGROUND Breast cancer survivors experience long-term physical and psychological sequelae after their primary treatment that negatively influence their quality of life (QOL) and increase depressive symptoms. Group-based cognitive-behavioral stress management (CBSM) delivered after surgery for early-stage breast cancer was previously associated with better QOL over a 12-month follow-up and with fewer depressive symptoms up to 5 years after study enrollment. This 8- to 15-year follow-up (median, 11 years) of a previously conducted trial (NCT01422551) evaluated whether women in this cohort receiving CBSM had fewer depressive symptoms and better QOL than controls at an 8- to 15-year follow-up. METHODS Women with stage 0 to IIIb breast cancer were initially recruited 2 to 10 weeks after surgery and randomized to a 10-week CBSM intervention or a 1-day psychoeducational control group. One hundred women (51 CBSM patients and 49 controls) were recontacted 8 to 15 years after study enrollment to participate in a follow-up assessment. The Center for Epidemiologic Studies–Depression (CES-D) scale and the Functional Assessment of Cancer Therapy–Breast (FACT-B) were self-administered. Multiple regression was employed to evaluate group differences on the CES-D scale and FACT-B over and above effects of confounding variables. RESULTS Participants assigned to CBSM reported significantly lower depressive symptoms (d, 0.63; 95% confidence interval [CI], 0.56-0.70) and better QOL (d, 0.58; 95% CI, 0.52-0.65) above the effects of the covariates. CONCLUSIONS Women who received CBSM after surgery for early-stage breast cancer reported lower depressive symptoms and better QOL than the control group up to 15 years later. Early implementation of cognitive-behavioral interventions may influence long-term psychosocial functioning in breast cancer survivors. Cancer 2015;121:1873–1881. © 2015 American Cancer Society.

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TL;DR: How self-reported QoL of adolescents with cerebral palsy varies with impairment and compares with the general population, and how factors in childhood predict adolescent QOL are examined, are examined.

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15 Mar 2015-Cancer
TL;DR: A study to investigate the impact of hospitalization for hematopoietic stem cell transplantation (HCT) on the quality of life (QOL) and mood of patients and family caregivers (FC).
Abstract: Background To investigate the impact of hospitalization for hematopoietic stem cell transplantation (HCT) on patients’ and family caregivers’ (FC) quality of life (QOL) and mood.

Journal ArticleDOI
TL;DR: Health coaching with and without access to mobile technology appeared to improve glucoregulation and mental health in a lower-SES, T2DM population and the accelerated improvement in the mobile phone group suggests the connectivity provided may more quickly improve adoption and adherence to health behaviors within a clinical diabetes management program.
Abstract: Background: Adoptions of health behaviors are crucial for maintaining good health after type 2 diabetes mellitus (T2DM) diagnoses. However, adherence to glucoregulating behaviors like regular exercise and balanced diet can be challenging, especially for people living in lower-socioeconomic status (SES) communities. Providing cost-effective interventions that improve self-management is important for improving quality of life and the sustainability of health care systems. Objective: To evaluate a health coach intervention with and without the use of mobile phones to support health behavior change in patients with type 2 diabetes. Methods: In this noninferiority, pragmatic randomized controlled trial (RCT), patients from two primary care health centers in Toronto, Canada, with type 2 diabetes and a glycated hemoglobin/hemoglobin A1c (HbA1c) level of ≥7.3% (56.3 mmol/mol) were randomized to receive 6 months of health coaching with or without mobile phone monitoring support. We hypothesized that both approaches would result in significant HbA1c reductions, although health coaching with mobile phone monitoring would result in significantly larger effects. Participants were evaluated at baseline, 3 months, and 6 months. The primary outcome was the change in HbA1c from baseline to 6 months (difference between and within groups). Other outcomes included weight, waist circumference, body mass index (BMI), satisfaction with life, depression and anxiety (Hospital Anxiety and Depression Scale [HADS]), positive and negative affect (Positive and Negative Affect Schedule [PANAS]), and quality of life (Short Form Health Survey-12 [SF-12]). Results: A total of 138 patients were randomized and 7 were excluded for a substudy; of the remaining 131, 67 were allocated to the intervention group and 64 to the control group. Primary outcome data were available for 97 participants (74.0%). While both groups reduced their HbA1c levels, there were no significant between-group differences in change of HbA1c at 6 months using intention-to-treat (last observation carried forward [LOCF]) ( P =.48) or per-protocol ( P =.83) principles. However, the intervention group did achieve an accelerated HbA1c reduction, leading to a significant between-group difference at 3 months ( P =.03). This difference was reduced at the 6-month follow-up as the control group continued to improve, achieving a reduction of 0.81% (8.9 mmol/mol) ( P =.001) compared with a reduction of 0.84% (9.2 mmol/mol)( P =.001) in the intervention group. Intervention group participants also had significant decreases in weight ( P =.006) and waist circumference ( P =.01) while controls did not. Both groups reported improvements in mood, satisfaction with life, and quality of life. Conclusions: Health coaching with and without access to mobile technology appeared to improve glucoregulation and mental health in a lower-SES, T2DM population. The accelerated improvement in the mobile phone group suggests the connectivity provided may more quickly improve adoption and adherence to health behaviors within a clinical diabetes management program. Overall, health coaching in primary care appears to lead to significant benefits for patients from lower-SES communities with poorly controlled type 2 diabetes. Trial Registration: ClinicalTrials.gov NCT02036892; http://clinicaltrials.gov/ct2/show/NCT02036892 (Archived by WebCite at http://www.webcitation.org/6b3cJYJOD) [J Med Internet Res 2015;17(10):e224]