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Purpose: The Social Difficulties Inventory (SDI-21) assesses everyday problems experienced by cancer patients, including difficulties with self-care, work and relationships. Early development and psychometric evaluation studies have validated the SDI-21 for computer administration. However, several recent studies have administered the SDI-21 on paper. We sought to test the score equivalence of electronic and paper versions of the SDI-21. Methods: A randomised two-arm crossover trial in a sample of cancer patients with varied diagnoses. Patients completed electronic (via the internet) and paper versions of the SDI-21, with half randomly assigned to complete the electronic version first ( n = 51) and half the paper version first ( n = 60). Patients were asked to complete both versions at home, within 2 weeks. Analyses were performed for the SDI-21 summary score and three subscales. Results: Score distributions and internal reliabilities for the paper and electronic versions were highly similar. There were no significant differences between mean summary or subscale scores for the two administration modes. All mean score differences (all <0.25 of a scale point) were well below the SDI-21's established minimally important differences, and all 95 % confidence intervals were narrow and included zero. Intraclass correlations between paper and electronic scores were uniformly high and significant (all ≥0.85) and above the standard acceptable level of reliability. Conclusions: Paper and electronic versions of the SDI-21 can be considered equivalent and used interchangeably. This is important because, despite the growth of electronic formats, paper versions are currently still necessary to ensure inclusive use of the SDI-21 with representative samples. [ABSTRACT FROM AUTHOR]

Purpose: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core Questionnaire (QLQ-C30) is a widely used generic self-report measure of health-related quality of life (HRQOL) for cancer patients. However, no validated voice script for interviewer-led telephone administration was previously available. The aim of this study was to develop a voice script for interviewer administration via telephone. Methods: Following guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Mixed Modes Good Research Practices Task Force, a randomised cross-over equivalence study, including cognitive debriefing, was conducted to assess equivalence between paper and telephone administration modes. Assuming an expected intraclass correlation coefficient (ICC) of 0.70 and a minimally acceptable level of 0.50, a sample size of 63 was required. Results: Cognitive interviews with five cancer patients found the voice script to be clear and understandable. Due to a protocol deviation in the first wave of testing, only 26 patients were available for analyses. A second wave of recruitment was conducted, adding 37 patients (n = 63; mean age 55.48; 65.1% female). Total ICCs for mode comparison ranged from 0.72 (nausea and vomiting, 95% CI 0.48–0.86) to 0.90 (global health status/QoL, 95% CI 0.80–0.95; pain, 95% CI 0.79–0.95; constipation, 95% CI 0.80–0.95). For paper first administration, all ICCs were above 0.70, except nausea and vomiting (ICC 0.55; 95% CI 0.24–0.76) and financial difficulties (ICC 0.60; 95% CI 0.31–0.79). For phone first administration, all ICCs were above 0.70. Conclusions: The equivalence testing results support the voice script's validity for administration of the QLQ-C30 via telephone. [ABSTRACT FROM AUTHOR]

Purpose: In a randomised controlled trial, patients were offered financial incentives to improve their adherence to anti-psychotic maintenance medication. Compared to a control group without the incentives, they had an improved adherence and also better subjective quality of life (SQOL) after 1 year. This paper explores the question as to whether this improvement in SQOL was associated with the amount of money received or with the improved adherence itself.Method: A secondary analysis was performed using data of the experimental group in the trial. Adherence was assessed as the percentage of all prescribed long-acting anti-psychotic injections that were taken by the patient. In regression models, we tested whether changes in medication adherence and/or the amount of incentives received over the 12-month period was associated with SQOL, as rated on the DIALOG scale.Results: Adherence changed from 68.49 % at baseline to 88.23 % (mean difference in adherence = 19.59 %, SD = 17.52 %). The total amount of incentives received within the 1-year study period varied between £75 and £735, depending on the treatment cycle and the number of long-acting injections taken. Improvement in adherence was found to be a significant predictor of better subjective quality of life (β = 0.014, 95 % CI 0.003-0.025, p = 0.014), whilst the amount of incentives received was not (β = 0.0002, 95 % CI -0.002 to 0.002, p = 0.818).Conclusion: Improved medication adherence is associated with a more favourable SQOL. This underlines the clinical relevance of improved adherence in response to financial incentives in this patient group. [ABSTRACT FROM AUTHOR]

Purpose: To summarize the current evidence regarding the effectiveness of intradialytic exercise (IDE) on the health-related quality of life (HRQOL) of patients undergoing maintenance haemodialysis. Methods: Five English databases (PubMed, EMBASE, Cochrane Library, Web of Science, and ScienceDirect) and four Chinese databases (VIP, WAN FANG, CNKI, CBM) were comprehensively searched from their inception to 18 March 2021. This study was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Two independent reviewers selected the papers and extracted the details of each study therein. Only randomized controlled trials were included. The risk of bias tool version 2.0 was used to evaluate the risk of bias of the included studies. A random-effects meta-analysis was conducted to pool the effect size. Results: Thirty-three eligible studies with 1481 participants were included. For the generic HRQOL, assessed by the Medical Outcomes Study Short-Form survey, IDE significantly improved most domains and the physical component summary compared with the control group. Furthermore, aerobic exercise alone significantly improved more domains compared to resistance exercise, combined aerobic and resistance exercise, and other types of exercise. Regarding the kidney-specific HRQOL, IDE improved three of eleven domains, including the symptom/problem list, the effect of kidney disease, and the quality of social interaction. No significant effect was found on other domains of kidney-specific HRQOL. Conclusion: Intradialytic exercise could benefit patients undergoing haemodialysis in improving most domains of generic HRQOL, but the effect on most domains of kidney-specific HRQOL is insufficient. [ABSTRACT FROM AUTHOR]

Introduction: The chief therapeutic goal in metastatic prostate cancer is prolongation of survival with good quality of life . Quality of life (health-related) is often used as an endpoint parameter in phase III trials in metastatic prostate cancer, but the value of using HRQOL in this context has not been assessed to date.Methods: In order to evaluate the role of HRQOL assessment in contemporary phase III trials in prostate cancer, we searched the PubMed database to identify publications presenting the results of these trials on systemic therapies for prostate cancer published between January 2000 and December 2015. The analysis was separately presented in ten leading journals. We searched for companion papers reporting on QOL separately.Results: We identified 84 studies which included a total of 57,193 patients in ten leading journals and 27 studies (7270 patients) in other journals. HRQOL parameters were described or mentioned in the main publication in 25 publications and four companions in total. There was no obvious trend in quality of life reported over two 8-year periods . The explicit statistical comparisons were reported in 22/25 cases (88 %), with significant difference in only 10/25 (40 %) studies and in eight cases (80 %) was conducive to the examined arm. There was no significant association between improvements in HRQOL and improvements in overall survival (OS) or any other primary endpoint in the analyzed studies. Only one study was found which presented the difference in quality of life with no difference in the primary endpoint.Conclusions: HRQOL is an indicator of benefit during treatment of patients with metastatic prostate cancer, but it is unlikely that HRQOL results can help clinicians choose between treatments given that they are not correlated with changes in OS or at other primary endpoints. [ABSTRACT FROM AUTHOR]

Purpose: Patient-reported outcome measures (PROMs) are designed to assess patients' perceived health states or health-related quality of life. However, PROMs are susceptible to missing data, which can affect the validity of conclusions from randomised controlled trials (RCTs). This review aims to assess current practice in the handling, analysis and reporting of missing PROMs outcome data in RCTs compared to contemporary methodology and guidance. Methods: This structured review of the literature includes RCTs with a minimum of 50 participants per arm. Studies using the EQ-5D-3L, EORTC QLQ-C30, SF-12 and SF-36 were included if published in 2013; those using the less commonly implemented HUI, OHS, OKS and PDQ were included if published between 2009 and 2013. Results: The review included 237 records (4-76 per relevant PROM). Complete case analysis and single imputation were commonly used in 33 and 15 % of publications, respectively. Multiple imputation was reported for 9 % of the PROMs reviewed. The majority of publications (93 %) failed to describe the assumed missing data mechanism, while low numbers of papers reported methods to minimise missing data (23 %), performed sensitivity analyses (22 %) or discussed the potential influence of missing data on results (16 %). Conclusions: Considerable discrepancy exists between approved methodology and current practice in handling, analysis and reporting of missing PROMs outcome data in RCTs. Greater awareness is needed for the potential biases introduced by inappropriate handling of missing data, as well as the importance of sensitivity analysis and clear reporting to enable appropriate assessments of treatment effects and conclusions from RCTs. [ABSTRACT FROM AUTHOR]

Objective: This paper evaluates the effectiveness of motivational enhancement therapy plus cognitive behavioural therapy on depressive symptoms, glycosylated haemoglobin, fasting glucose, body mass index (BMI), and health-related quality of life in type II diabetes patients.Methods: A controlled trial was conducted to compare patients who received the behavioural intervention with untreated controls on measures of health outcomes. A total of 31 intervention group participants and 30 controls were selected from patients that met the inclusion criteria from a hospital-based endocrinology outpatient department. The outcome measures including depressive symptoms, glycosylated haemoglobin, fasting glucose, BMI, and both physical and mental quality of life were collected before (T1), after (T2), and after 90 days (T3) following the intervention.Results: The experimental group showed a significant reduction in glycosylated haemoglobin, fasting glucose, and depressive symptoms and a significant increase in physical quality of life and mental quality of life at T2 and T3, while patients in the control group with usual care showed no changes over time.Conclusion: The behavioural intervention facilitated a significant improvement in psychological adjustment and glycemic control, thus strengthening diabetes control skills and leading to healthy outcomes. It is feasible that nurses and psychiatrists can deliver the behavioural intervention for diabetes patients to decrease their depressive symptoms. Sharing discussion and problem-solving experiences is particularly helpful method for self-control, and these will be beneficially influential on further research. [ABSTRACT FROM AUTHOR]

Purpose: To review the literature focusing on the effects of dietary behavioural changes on cancer patients' health-related quality of life (HRQOL). Methods: Relevant databases were searched for studies that report the relationship between dietary changes and HRQOL of people with cancer and synthesized and systematically reviewed the available evidence. Papers were assessed for methodological quality, and the themes identified were summarized. Results: The selected studies included only randomized control trials, which target changes in diet. Twelve studies were identified, which focus on the association between lifestyle changes that included changes in diet and HRQOL among cancer patients. Results have been mixed, and dietary changes have been shown to partly affect HRQOL, but other factors seem to be important as well in defining that relationship. Moreover, cancer groups with higher survival rates (prostate, breast, colorectal) seem to benefit more from dietary changes, while different HRQOL constructs are affected with no clear indication of directional benefits on physical or mental health. Conclusions: Even though there are some indications of a direct relationship between dietary changes and HRQOL, further research should establish which areas of HRQOL are directly affected. Perhaps, nutritional changes in future interventions can be isolated in order to identify a potential direct relationship with HRQOL. [ABSTRACT FROM AUTHOR]

Background: We implemented a comprehensive intervention program targeting general practice staff, that proved successful in optimizing practice organization and clinical decision-making. In this paper, health-related quality of life (HRQL) is investigated as a clinical outcome.Objective: To evaluate the effect of the implementation of an intervention program on the HRQL in patients at high cardiovascular risk.Research Design: Randomized controlled trial. Intervention practices (n = 62) received a comprehensive intervention program (by means of outreach visitors) lasting 21 months. HRQL of patients at high cardiovascular risk was assessed by the MOS 36-Item Short-Form Health Survey (SF-36), at baseline and after intervention. Three patient categories were distinguished: diabetes mellitus, cardiovascular disease and hypertension.Results: HRQL deteriorated in all respondents, but more pronounced in the control group. In diabetes patients the differences between intervention and control group were significant for the Vitality and Mental Health scales, with mean difference in change of 3.93 (95% CI: 1.08-6.78) and 3.71 (95% CI: 0.73-6.68), respectively. Patients with cardiovascular disease had significantly different changes on three scales: physical functioning (3.57, 95% CI: 0.71-6.43), vitality (3.01, 95% CI: 0.72-5.30) and social functioning (3.96, 95% CI: 0.50-7.42). In patients with hypertension, there were no differences between the intervention and control group.Conclusion: Our comprehensive intervention program resulted in changes in HRQL on several domains, particularly in patients with diabetes and cardiovascular disease. [ABSTRACT FROM AUTHOR]

Purpose: This paper reports on the development and validation of two biologic response modifier (BRM) subscales for use with the Functional Assessment of Cancer Therapy-General (FACT-G) quality of life (QOL) questionnaire.Methods: Using the FACT-G as a base, 17 additional questions related to symptoms common to interferon and retinoid therapy were developed. Data collected at baseline (n = 191) and week 2 (n = 168) in a randomized trial of interferon +/- 13-cis-retinoic acid in advanced renal cell carcinoma patients were used to validate this measure.Results: Using a combined empirical and conceptual approach, the 17 questions were reduced to 13 questions consisting of two subscales: 'BRM-physical' (7 items; baseline coefficient alpha(alpha) = 0.70; week-2 alpha = 0.75) and 'BRM-mental' (6 items; baseline alpha = 0.79; week-2 alpha = 0.78). Internal consistency of the trial outcome index (TOI) combining physical well-being, functional well-being and the BRM subscales, was 0.91 for baseline assessments and 0.92 for week 2. Discriminant validity was demonstrated for the TOI by its ability to differentiate among prognostic risk groups, and for the total FACT-G, TOI and total FACT-BRM scores by their ability to distinguish between groups differing in performance, response and toxicity status.Conclusions: The 'BRM-physical' and 'BRM-mental' subscales can be combined with the FACT-G to form the 'FACT BRM' scale, useful for measuring QOL in cancer patients who are receiving treatment with biologic response modifiers. [ABSTRACT FROM AUTHOR]

Purpose: Using data from a randomized controlled trial for treatment of prescription-type opioid use disorder in Canada, this study examines sensitivity to change in three preference-based instruments [EQ-5D-3L, EQ-5D-5L, and the Health Utilities Index Mark 3 (HUI3)] and explores an oft-overlooked consideration when working with contemporaneous responses for similar questions—data quality. Methods: Analyses focused on the relative abilities of three instruments to capture change in health status. Distributional methods were used to categorize individuals as 'improved' or 'not improved' for eight anchors (seven clinical, one generic). Sensitivity to change was assessed using area under the ROC (receiver operating characteristics) curve (AUC) analysis and comparisons of mean change scores for three time periods. A 'strict' data quality criteria, defined a priori, was applied. Analyses were replicated using 'soft' and 'no' criteria. Results: Data from 160 individuals were used in the analysis; 30% had at least one data quality violation at baseline. Despite mean index scores being significantly lower for the HUI3 compared with EQ-5D instruments at each time point, the magnitudes of change scores were similar. No instrument demonstrated superior sensitivity to change. While six of the 10 highest AUC estimates were for the HUI3, 'moderate' classifications of discriminative ability were identified in 12 (of 22) analyses for each EQ-5D instrument, compared with eight for the HUI3. Conclusion: Negligible differences were observed between the EQ-5D-3L, EQ-5D-5L, and HUI3 regarding the ability to measure change. The prevalence of data quality violations—which differed by ethnicity—requires further investigation. [ABSTRACT FROM AUTHOR]

To explore the value of antiandrogen therapy for advanced prostate cancer, two clinical trials of similar design were recently conducted in six countries throughout Europe. A total of 550 patients with previously untreated metastatic prostate cancer were randomized either to treatment with an antiandrogen or castration. While time to treatment failure, objective tumour response and survival were expected to be similar between study treatments, their effects on health-related quality of life (HRQOL) were expected to differ and were therefore a focus of concern in this trial. To assess these effects, we developed a brief self-administered patient questionnaire covering 10 domains of HRQOL (general health perceptions, pain, emotional well-being, vitality, social functioning, physical capacity, sexual interest, sexual functioning, activity limitation and bed disability), which we translated from English into several other languages. In this paper, we describe the development, content and translation of this survey instrument and report on its reliability and validity in six countries based on data collected for the first 487 patients to complete questionnaires at study entry. [ABSTRACT FROM AUTHOR]

Purpose: In order to enable cost-utility analysis of shoulder pain conditions and treatments, this study aimed to develop and evaluate mapping algorithms to estimate the EQ-5D health index from the Oxford Shoulder Score (OSS) when health outcomes are only assessed with the OSS. Methods: 5437 paired OSS and EQ-5D questionnaire responses from four national multicentre randomised controlled trials investigating different shoulder pathologies and treatments were split into training and testing samples. Separate EQ-5D-3L and EQ-5D-5L analyses were undertaken. Transfer to utility (TTU) regression (univariate linear, polynomial, spline, multivariable linear, two-part logistic-linear, tobit and adjusted limited dependent variable mixture models) and response mapping (ordered logistic regression and seemingly unrelated regression (SUR)) models were developed on the training sample. These were internally validated, and their performance evaluated on the testing sample. Model performance was evaluated over 100-fold repeated training–testing sample splits. Results: For the EQ-5D-3L analysis, the multivariable linear and splines models had the lowest mean square error (MSE) of 0.0415. The SUR model had the lowest mean absolute error (MAE) of 0.136. Model performance was greatest in the mid-range and best health states, and lowest in poor health states. For the EQ-5D-5L analyses, the multivariable linear and splines models had the lowest MSE (0.0241–0.0278) while the SUR models had the lowest MAE (0.105–0.113). Conclusion: The developed models now allow accurate estimation of the EQ-5D health index when only the OSS responses are available as a measure of patient-reported health outcome. [ABSTRACT FROM AUTHOR]

Aim: A systematic literature review of immuno-oncology trials was conducted to assess the potential impact of open-label vs double-blind trial design on patient-reported outcome (PRO) data. Methods: A systematic search of indexed literature published from January 2009 to May 2019 was conducted using PubMed/MEDLINE, Cochrane Library, and EMBASE database. All randomized clinical trials (RCTs) of immuno-oncology therapies on advanced cancer patients reporting PRO data were identified. Descriptive analyses were performed to quantify differences at baseline and over time, by the type of study, regarding questionnaire completion rate and PRO scores. Results: In total, 23 studies were retained (15 open-label, 8 blinded). At baseline, no difference in completion rate was observed between arms irrespective of trial design (absolute mean difference of 2.8% and 2.2% for open label and blinded studies, respectively). No clinically significant difference in baseline PRO scores was observed between arms. Over time, impact on PRO scores could not be identified due to the limited number of studies, heterogeneity of questionnaires and tumor types. Conclusions: Trial design had no impact on PRO completion rate or baseline scores. Future research should involve analyses by specific cancer types and ideally compare individual data from two similar RCTs (blinded vs. open-label). [ABSTRACT FROM AUTHOR]

Purpose: Cancer patients often report low self-esteem and high emotional distress. Two factors seem particularly linked to these symptoms: emotion regulation strategies and mindfulness. The interest of hypnosis and self-care to relieve these symptoms is not well documented. Our randomized controlled trial aimed at assessing the effect of a group intervention combining self-hypnosis and self-care on self-esteem, emotional distress, emotion regulation, and mindfulness abilities of post-treatment cancer patients, as well as investigating the links between these variables. Methods: One hundred and four patients who had suffered from cancer were randomized into the intervention group (N = 52) and the wait-list control group (N = 52). They had to answer questionnaires before (T1) and after the intervention (T2). Nine men were excluded from the analyses, leading to a final sample of 95 women with cancer. Group-by-time changes were assessed with MANOVA, and associations with self-esteem and emotional distress were investigated with hierarchical linear regression models. Results: Participants in the intervention group (mean age = 51.65; SD = 12.54) reported better self-esteem, lower emotional distress, a decreased use of maladaptive emotion regulation strategies, and more mindfulness abilities after the intervention, compared to the WLCG. This increase in mindfulness explained 33% of the improvement of self-esteem and 41.6% of the decrease of emotional distress in the intervention group. Self-esteem and emotional distress also predicted each other. Conclusion: Our study showed the efficacy of our hypnosis-based intervention to improve all the investigated variables. Mindfulness predicted the improvement of self-esteem and emotional distress. The primary impact of our intervention on mindfulness abilities seems to explain, at least in part, its efficacy. Registration: ClinicalTrials.gov (NCT03144154). Retrospectively registered on the 1st of May, 2017. [ABSTRACT FROM AUTHOR]

Purpose: During adolescence, adolescents are more susceptible to internalizing and externalizing problems influencing quality of life (QoL). The purpose of the study is to verify the effectiveness of a peer education on improving QoL of adolescents.Methods: A cluster randomized controlled trial (RCT) was conducted involving 1564 subjects who were divided into an intervention group (n = 714) and a control group (n = 850). The intervention group received 1-year peer education. Their QoL and basic information were assessed using a Adolescent Quality of Life Scale and a self-designed basic situation questionnaire.Results: After the intervention, significant increases were found in the psychological, and social, pubertal dimensions, and in total QoL (P < 0.05) in the intervention group relative to the control group. Significant decrease was found in physical dimension (P < 0.05), but the change in the intervention group (0.74 decrease) was much less than that in the control group (1.94 decrease). The improvements of physical (B = 1.215, SE = 0.305, P < 0.001), psychological (B = 1.496, SE = 0.598, P = 0.013), pubertal (B = 0.828, SE = 0.244, P = 0.001), and total (B = 3.455, SE = 1.429, P = 0.016) QoL in the intervention group were higher than in the control group in mixed model.Conclusions: The peer education based on adolescent health education is effective in improving the physical, psychological, pubertal, and total QoL of adolescents, but no social QoL. [ABSTRACT FROM AUTHOR]

Background: The effect of nature-based interventions on self-reported mental well-being in patients with physical disease is gaining increasing attention. However, there is a lack of randomized controlled trials investigating this area. Due to the massive costs in health care systems, there is a need for new strategies to address these issues and an urgent need for attention to this field. Nature-based interventions are low cost, easy to implement, and should get attention within the health care field. Therefore, the objective was to find the impact of nature interventions on mental well-being in humans with a physical disease.Methods: In four major databases (PubMed, Cinahl, PsycINFO, and Cochrane Library), a systematic review of quantitative studies of nature's impact on self-reported mental health in patients with physical disease was performed. A total of 1909 articles were retrieved but only five met the inclusion criteria and were summarized.Results: All five studies were quantitative, with a control group and a nature-based intervention. A source of heterogeneity was identified: the patients in one of the five studies were psychosomatic. In the four studies with somatic patients, significant benefit of nature on self-reported mental health outcomes was found; the only study that failed to show a significant benefit was the one with psychosomatic patients.Conclusion: A significant effect of nature on mental well-being of patients with somatic disease was found. The result in patients with psychosomatic disease is inconclusive, and more studies in this category are needed. Further research on the effect of nature on mental health is merited, with special attention to standardizing intervention type and dose as well as outcome measures within each medical discipline. [ABSTRACT FROM AUTHOR]

Objective: Given the global and economic burden of stroke as a major cause of long-term disability, patient-reported outcomes (PRO) data from clinical trials can elucidate differential benefits/harms of interventions from patients' perspectives and influence clinical decision making in stroke care management.Methods: This systematic review examines stroke-related randomized controlled trials (RCT) published in 12 high-impact journals between 2002 and 2016 for (1) associations between trial characteristics and the reporting of PRO measures; and (2) psychometric properties of PRO instruments used in these studies. The study combines clinical trials identified in a prior review with trials identified with an updated literature search.Results: Only 34 of 159 stroke-related RCTs reported PRO measures. Among the 34 trials, most were published in rehabilitation and general medical journals, were conducted in the United States or Europe, were funded by government/non-industry sponsors, and focused on post-stroke care. Thirty-one PRO instruments were employed in these studies. Only 5 instruments were stroke-specific measures, whereas the remaining 26 instruments were generic measures. Eight instruments assessed functional status, 9 measured quality of life, and 14 assessed symptoms. The most common health domains measured were emotional status and physical function.Conclusions: This study highlights the paucity of information from patients' perspective in stroke-related RCTs. This trend may change over time as researchers increase adherence to reporting guidelines for clinical trial protocols. [ABSTRACT FROM AUTHOR]

Purpose: Patient decision-aids (PtDAs) help patients make informed treatment decisions incorporating their values. Health-related quality of life (HRQOL) is sometimes an outcome of PtDA effectiveness trials, but its suitability for this purpose is unclear. We sought to provide insights into this question by critically appraising how randomized controlled trials (RCTs) evaluating PtDA effectiveness measure and report HRQOL.Methods: We conducted a sub-analysis of RCTs included in the 2017 Cochrane review of PtDAs. Trials assessing HRQOL at baseline and post-PtDA, and comparing PtDA with comparison groups were included. Two reviewers independently extracted data and assessed study quality. Analysis was descriptive.Results: Of 105 RCTs, 11 were eligible for inclusion. Patients randomized to PtDAs did not report better HRQOL than those randomized to usual care. While all 11 RCTs adequately described baseline sample characteristics and reported HRQOL results for study groups, few stated a priori HRQOL expectations or hypotheses (36%); made a link between HRQOL and the decision (18%); provided a rationale or justification for HRQOL assessment (18%); provided reason for choice of HRQOL assessment time-points (9%); or adjusted p-values for multiple HRQOL domains and time-points (0%).Discussion: PtDAs did not conclusively impact HRQOL. If this holds generally, then HRQOL is an uninformative endpoint for PtDA effectiveness trials. When planning trials of PtDAs, investigators considering HRQOL endpoints should consider whether and why their PtDA is likely to affect HRQOL in their context, and if so, which specific aspect(s) of HRQOL and at which time-point(s), and ensure HRQOL is assessed accordingly. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcome measures (PROMs) could play an important role in identifying patients' needs and goals in clinical encounters, improving communication and decision-making with clinicians, while making care more patient-centred. Comprehensive evidence that PROMS are an effective intervention is lacking in single randomised controlled trials (RCTs).Methods: A systematic search was performed using controlled vocabulary related to the terms: clinical care setting and patient-reported outcome. English language studies were included if they were a RCT with a PROM as an intervention in a patient population. Included studies were analysed and their methodologic quality was appraised using the Cochrane Risk of Bias tool. The protocol was registered with PROSPERO (CRD42016034182).Results: Of 4302 articles initially identified, 115 underwent full-text review resulting in 22 studies reporting on 25 comparisons. The majority of included studies were conducted in USA (11), among cancer patients (11), with adult participants only (20). Statistically significant and robust improvements were reported in the pre-specified outcomes of the process of care (2) and health care (3). Additionally, five, eight and three statistically significant but possibly non-robust findings were reported in the process of care, health and patient satisfaction outcomes, respectively.Conclusions: Overall, studies that compared PROM to standard care either reported a positive effect or were not powered to find pre-specified differences. There is justification for the use of a PROM as part of standard care, but further adequately powered studies on their use in different contexts are necessary for a more comprehensive evidence base. [ABSTRACT FROM AUTHOR]

Purpose: (1) To determine the effects of a 9-month resistance training intervention on quality of life, sense of coherence, and depressive symptoms in older adults, and (2) to compare effects between different training frequencies.Methods: Men and women aged 65-75 (N = 106) were randomized to four groups according to training frequency: training groups RT1 (n = 26), RT2 (n = 27), and RT3 (n = 28) and non-training control group (n = 25). All training groups attended supervised resistance training twice a week for 3 months. For the following 6 months, they continued training with different frequencies (1, 2 or 3 times per week). Psychological functioning was measured by quality of life (WHOQOL-Bref), sense of coherence (Antonovsky's SOC-13), and depressive symptoms (Beck's Depression Inventory II). Measurements were conducted at baseline and 3 and 9 months after baseline. The effects of the intervention were analyzed using generalized estimating equations (GEE).Results: After 3 months, there was an intervention effect on environmental quality of life (group × time p = .048). Between 3 and 9 months, environmental quality of life decreased among RT1 compared to RT2 and RT3 (group × time p = .025). Between baseline and 9 months, environmental quality of life increased in RT2 compared to all other groups (group × time p = .011). Sense of coherence increased in RT2 compared to the control group and RT3 (group × time p = .032).Conclusion: Resistance training is beneficial for environmental quality of life and sense of coherence. Attending resistance training twice a week seems to be the most advantageous for these aspects of psychological functioning. [ABSTRACT FROM AUTHOR]

Purpose: This study was to evaluate the efficacy of a complementary Chinese treatment modality Guolin-Qigong (GLQG) for patients with breast cancer on the body-mind health.Methods: A randomized controlled clinical trial was conducted among 158 women with breast cancer. Subjects were randomized to receive GLQG (test group) versus a physical stretching program (control group) following conventional treatment for breast cancer. GLQG and stretching interventions were performed twice a week over 24 weeks. The primary outcome was the change in quality of life (QoL). Secondary outcome measures included anxiety, depression, and clinical indicators. All participants were assessed at four time-points, at the beginning of the study (T1), after 12 weeks of the intervention (T2), immediately after 24-week intervention (T3), and at 48-week follow-up visit (T4).Results: Improvements in QoL were evident in both groups but the test group fared better than the control group at the 12th week (P < 0.01) and particularly in emotional well-being (P < 0.01) and breast cancer-specific well-being (P < 0.001). The test group showed an improvement in anxiety levels (P < 0.01), whereas the control group showed improvements in depression (P < 0.05) but there was no significant difference between groups (P > 0.05). Both groups showed improvements in immunological function and the test group fared better than the control in TNF-α levels (P < 0.05). The results in subjects who practiced more than 4 times and 6 h per week were similar to that of all subjects; however, the improvement in anxiety in the GLQG group was more obvious. There are positive correlations between QoL and anxiety and depression.Conclusions: Both GLQG and physical stretching are beneficial during recovery following breast cancer. GLQC was more effective in terms of Qol improvements than physical stretching. Both programs brought improvements in anxiety or depression but had were comparable. GLQC group had a greater effect on immunological function than physical exercise. [ABSTRACT FROM AUTHOR]

Purpose: To report the results of a randomized controlled trial using an electronic monitoring device (EM) plus a motivational interviewing (MI) intervention to enhance adherence to disease-modifying therapies (DMT) in pediatric MS.Methods: Fifty-two youth with MS (16.03 ± 2.2 years) were randomized to receive either MI (n = 25) (target intervention) or a MS medication video (n = 27) (attention control). Primary endpoint was change in adherence. Secondary outcomes included changes in quality of life, well-being and self-efficacy. Random effects modeling and Cohen's effect size computation evaluated intervention impact.Results: Longitudinal random effect models revealed that the MI group decreased their EM adherence (GroupxTime interaction = -0.19), while increasing frequency of parental DMT reminder (26.01)/administration (11.69). We found decreased EM use in the MI group at 6 months (Cohen's d = -0.61), but increased pharmacy refill adherence (d = 0.23). Parental reminders about medication increased in MI subjects vs controls (d = 0.59 at 3 months; d = 0.70 at 6 months). We found increases in self-reported adherence (d = 0.21) at 3 but not 6 months, fewer barriers to adherence at three (d = -0.58) and six months (d = -0.31), better physical (d = 0.23 at 3 months; d = 0.45 at 6 months), emotional (d = 0.25 at 3 months) and self-efficacy function (d = 0.55 at 3 months; 0.48 at 6 months), but worse well-being, including self-acceptance (d = -0.53 at 6 months) and environmental mastery (d = -0.42 at 3 and 6 months) in intervention as compared to control patients.Conclusions: Participants receiving MI + EM experienced worsening on objective measures of adherence and increased parental involvement, but improved on some self- and parent-reported measures. MI participants reported improvements in quality of life and self-efficacy, but worsened well-being. [ABSTRACT FROM AUTHOR]

Purpose: Efficient management of fibromyalgia (FM) requires precise measurement of FM-specific symptoms. Our objective was to assess the measurement properties of the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue item bank (FIB) in people with FM.Methods: We applied classical psychometric and item response theory methods to cross-sectional PROMIS-FIB data from two samples. Data on the clinical FM sample were obtained at a tertiary medical center. Data for the U.S. general population sample were obtained from the PROMIS network. The full 95-item bank was administered to both samples. We investigated dimensionality of the item bank in both samples by separately fitting a bifactor model with two group factors; experience and impact. We assessed measurement invariance between samples, and we explored an alternate factor structure with the normative sample and subsequently confirmed that structure in the clinical sample. Finally, we assessed whether reporting FM subdomain scores added value over reporting a single total score.Results: The item bank was dominated by a general fatigue factor. The fit of the initial bifactor model and evidence of measurement invariance indicated that the same constructs were measured across the samples. An alternative bifactor model with three group factors demonstrated slightly improved fit. Subdomain scores add value over a total score.Conclusions: We demonstrated that the PROMIS-FIB is appropriate for measuring fatigue in clinical samples of FM patients. The construct can be presented by a single score; however, subdomain scores for the three group factors identified in the alternative model may also be reported. [ABSTRACT FROM AUTHOR]

Purpose: Bladder cancer (BC) is one of the most common cancers worldwide. BC diagnosis and surveillance is based on cystoscopy (CS). CS impact on patient's depression, anxiety, and sexual satisfaction (SS) is not sufficiently studied. There are no data on patient's comfort with flexible or rigid CS.Methods: We prospectively evaluated pain perception (PP), depression, anxiety, and SS of 100 male patients who previously underwent at least one rigid CS in our department as surveillance after TURB procedure due to non-muscle-invasive BC and were scheduled for the next CS examination. The patients were randomized for flexible or rigid CS. Before CS, patients described their recalled rigid CS-related pain by NRS and fulfilled HADS and SS questionnaires. After CS, PP was re-evaluated immediately and HADS and SS within 7-10 days following the CS.Results: The baseline scores include 5.2 ± 2.6 points for rigid CS recalled pain, 7.2 ± 3.0 points for HADS anxiety, 5.8 ± 3.5 for depression, and 27.8 ± 5.1 for SS. The flexible CS-related pain was approximately three times lower than the recalled pain level and also than the current rigid CS related (p < 0.001). Mean SS score was two points lowered after rigid CS (p < 0.001). One point decrease in anxiety level was observed after flexible CS (p < 0.001). Multivariate analysis supported the hypothesis of patients benefiting from flexible CS in terms of pain perception, anxiety symptoms, and SS.Conclusions: Our study demonstrates the superiority of flexible CS in terms of pain alleviation, and shifts in SS and anxiety levels. [ABSTRACT FROM AUTHOR]

Purpose: The goal of chemotherapy for metastatic breast cancer (MBC) is to prolong survival and maintain health-related quality of life. This study aimed to evaluate long-term health status of patients with MBC who participated in the phase III randomized SELECT BC trial.Methods: In the SELECT BC trial, patients were randomly allocated to the S-1 or taxane (paclitaxel or docetaxel) arm. Health status was assessed by EQ-5D at pre-treatment, 3 and 6 months after randomization, and every 6 months thereafter to the extent possible. Least square mean scores were assessed to compare EQ-5D index values between groups. Time to deterioration analysis was also performed by defining the minimally important difference of EQ-5D as 0.05 or 0.1.Results: The number of patients for EQ-5D analysis was 175 and 208 in the taxane and S-1 arms, respectively. Least square mean EQ-5D index values up to 60 months were 0.741 (95 % CI [0.713-0.769]) in the taxane arm and 0.748 [0.722-0.775] in the S-1 arm. The EQ-5D index value during PFS up to 12 months in the S-1 was superior to the corresponding index value in the taxane (0.812 [0.789-0.834] vs. 0.772 [0.751-0.792], P = 0.009). Time to deterioration analysis also revealed that S-1 significantly delayed the deterioration of EQ-5D index value during the period before progression (P = 0.002 and 0.003).Conclusions: Our findings suggest that the EQ-5D index value was higher in patients treated with S-1 during first-line chemotherapy. Considering non-inferiority of S-1 in terms of OS, obtained quality-adjusted life years may be greater in the S-1 arm. [ABSTRACT FROM AUTHOR]

Purpose: Missing data are a major problem in the analysis of data from randomised trials affecting power and potentially producing biased treatment effects. Specifically focussing on quality of life outcomes, we aimed to report the amount of missing data, whether imputation was used and what methods and was the missing mechanism discussed from four leading medical journals and compare the picture to our previous review nearly a decade ago.Methods: A random selection (50 %) of all RCTS published during 2013-2014 in BMJ, JAMA, Lancet and NEJM was obtained. RCTs reported in research letters, cluster RCTs, non-randomised designs, review articles and meta-analysis were excluded.Results: We included 87 RCTs in the review of which 35 % the amount of missing primary QoL data was unclear, 31 (36 %) used imputation. Only 23 % discussed the missing data mechanism. Nearly half used complete case analysis. Reporting was more unclear for secondary QoL outcomes. Compared to the previous review, multiple imputation was used more prominently but mainly in sensitivity analysis.Conclusions: Inadequate reporting and handling of missing QoL data in RCTs are still an issue. There is a large gap between statistical methods research relating to missing data and the use of the methods in applications. A sensitivity analysis should be undertaken to explore the sensitivity of the main results to different missing data assumptions. Medical journals can help to improve the situation by requiring higher standards of reporting and analytical methods to deal with missing data, and by issuing guidance to authors on expected standard. [ABSTRACT FROM AUTHOR]

Objective: Cost per quality-adjusted life year data are required for reimbursement decisions in many Central and Eastern European (CEE) countries. EQ-5D is by far the most commonly used instrument to generate utility values in CEE. This study aims to systematically review the literature on EQ-5D from eight CEE countries.Methods: An electronic database search was performed up to 1 July 2015 to identify original EQ-5D studies from the countries of interest. We analysed the use of EQ-5D with respect to clinical areas, methodological rigor, population norms and value sets.Results: We identified 143 studies providing 152 country-specific results with a total sample size of 81,619: Austria (n = 11), Bulgaria (n = 6), Czech Republic (n = 18), Hungary (n = 47), Poland (n = 51), Romania (n = 2), Slovakia (n = 3) and Slovenia (n = 14). Cardiovascular (21 %), neurologic (17 %), musculoskeletal (15 %) and endocrine, nutritional and metabolic diseases (13 %) were the most frequently studied clinical areas. Overall, 112 (78 %) of the studies reported EQ VAS results and 86 (60 %) EQ-5D index scores, of which 27 (31 %) did not specify the applied tariff. Hungary, Poland and Slovenia have population norms. Poland and Slovenia also have a national value set.Conclusions: Increasing use of EQ-5D is observed throughout CEE. The spread of health technology assessment activities in countries seems to be reflected in the number of EQ-5D studies. However, improvement in informed use and methodological quality of reporting is needed. In jurisdictions where no national value set is available, in order to ensure comparability we recommend to apply the most frequently used UK tariff. Regional collaboration between CEE countries should be strengthened. [ABSTRACT FROM AUTHOR]

Purpose: Patients with myocardial infarction (MI) often report lower health-related quality of life (HRQoL) than those without MI. Interventions can affect HRQoL of these patients. The purpose of this review was to identify effective strategies for improving HRQoL among individuals with MI.Methods: Three electronic databases were searched and limited to articles peer-reviewed and published in English between 1995 and 2015. We screened titles and abstracts of the retrieved articles for studies that examined effectiveness of interventions to improve HRQoL in patients with MI.Results: Twenty-three studies were found that examined the effects of behavioural interventions-cardiac rehabilitation programmes (CRP), education and counselling programmes, and other psychological and cognitive interventions-to improve HRQoL in patients with MI. The studies included were mainly randomised controlled trials (14 studies) with a wide age range of participants (18-80 years) and a mean age group of 50-70 years. CRPs, including home- and hospital-based CRPs, regular weekly aerobic training programmes, and group counselling mostly resulted in improvement of HRQoL in patients with MI.Conclusion: Most CRPs and other interventions were beneficial to MI patients. Therefore, patients with MI should be encouraged to participate in programmes that can help promote their HRQoL. [ABSTRACT FROM AUTHOR]

Purpose: We conducted an evaluation to find out how a novel quality of life (QoL) intervention containing guided individualized feedback was appraised. The importance of QoL was matched with QoL assessment for each subjective dimension, using graphical feedback. We examined whether this information was acceptable, feasible and valued beyond the clinical context, among the community.Methods: Using a mixed-methods cross-sectional design, the intervention was piloted with 129 participants from communities and registered in primary care. WHOQOL-BREF and WHOQOL Importance scores were graphically matched by dimension. Results were inspected and interpreted with directed guidance to identify good and poor QoL. We report the post-intervention evaluation of feedback, including qualitative themes. Follow-up interviews among those expecting feedback to be helpful explored potential self-management and healthcare uses.Results: After feedback, 65 % reported changes in thoughts and perceptions of QoL, often describing insights as self-affirming. Goals or expectations changed for 34 %, and motivation to change was reported. Over 50 % evaluated the feedback as helpful in the short term or for the future. Follow-up interviews endorsed the value of the feedback and its usefulness in sharing with a healthcare professional (92 %), suggesting it would facilitate professionals' understandings of patients and enable health advice to be targeted.Conclusions: The benefits of using this novel feedback can be extended to the general population, as directed guidance aids interpretation, thereby saving health service costs. This complex pilot intervention needs testing in a blinded fully randomized controlled trial. Beyond independent self-management, graphs could be used during clinical decision-making. [ABSTRACT FROM AUTHOR]

Purpose: While intervention effects in target outcomes have typically been tested based on change from baseline to post-intervention, such approaches typically ignore individual differences in change, including time taken to see improvement. The present study demonstrates how weekly patient-reported data may be used to augment traditional pre-post intervention evaluations in order to gain greater insights into treatment efficacy.Methods: Two hundred and fifty-two adolescent boys and girls (M age = 13.6 years, SD = 0.6 years) from four secondary schools in Victoria, Australia, were assigned by school into control (n = 88) or intervention (n = 164) groups. The intervention group participated in a 6-week course designed to improve subjective wellbeing (SWB) by fostering resilience, coping skills, and self-esteem. In addition to baseline, post-intervention, and 3-month follow-up assessments of SWB, intervention group participants also completed weekly summarise of affective experiences for the duration of the intervention phase.Results: While standard pre-post data showed significant improvement in SWB for the intervention group relative to controls, weekly data showed individual differences in the trajectory of change during this intervention phase; low SWB individuals experienced initial worsening of symptoms followed by improvement in the second half of the intervention phase, whereas high SWB individuals experienced initial gains, followed by a plateau from Week 4 onwards.Conclusions: Addition of weekly data provided greater insights into intervention effects by: (1) contradicting the notion that early responsiveness to treatment is predictive of level of improvement by post-intervention, and (2) providing data-based insights into ways to enhance the intervention. [ABSTRACT FROM AUTHOR]

Purpose: The ICECAP-A is a simple measure of capability well-being for use with the adult population. The descriptive system is made up of five key attributes: Stability, Attachment, Autonomy, Achievement and Enjoyment. Studies have begun to assess the psychometric properties of the measure, including the construct and content validity and feasibility for use. This is the first study to use longitudinal data to assess the responsiveness of the measure. Methods: This responsiveness study was completed alongside a randomised controlled trial comparing three physiotherapy-led exercise interventions for older adults with knee pain attributable to osteoarthritis. Anchor-based methodologies were used to explore the relationship between change over time in ICECAP-A score (the target measure) and change over time in another measure (the anchor). Analyses were completed using the non-value-weighted and value-weighted ICECAP-A scores. The EQ-5D-3L was used as a comparator measure to contextualise change in the ICECAP-A. Effect sizes, standardised response means and t tests were used to quantify responsiveness. Results: Small changes in the ICECAP-A scores were seen in response to underlying changes in patients' health-related quality of life, anxiety and depression. Non-weighted scores were slightly more responsive than value-weighted scores. ICECAP-A change was of comparable size to change in the EQ-5D-3L reference measure. Conclusion: This first analysis of the responsiveness using longitudinal data provides some positive evidence for the responsiveness of the ICECAP-A measure. There is a need for further research in those with low health and capability, and experiencing larger underlying changes in quality of life. [ABSTRACT FROM AUTHOR]

Purpose: Although health-related quality of life (HRQL) is increasingly assessed in randomized controlled trials (RCTs), HRQL findings are not always incorporated into clinical decision making. We examined the current perspectives of oncologists on the use of HRQL findings from RCTs, and variation of these perspectives between countries and specialties. Methods: A cross-sectional e-survey of oncologist members of the NCIC Clinical Trials Group, the United Kingdom National Cancer Research Institute Clinical Studies Groups, and the Australia/New Zealand cancer clinical trials network was conducted. Respondents reported their perceptions of the usefulness of RCT HRQL outcomes for informing practice, their use of HRQL findings in practice, barriers/facilitators to this use, and preferences for HRQL data presentation in RCT publications. Chi-square tests compared responses between countries and specialties. Results: A total of 396 oncologists participated (estimated response rate: 30 %). The most frequently reported specialties were medical (46 %) and radiation (37 %) oncology. HRQL findings from RCTs were reported as useful (73 %), but were infrequently used to guide clinical decisions with patients. Perceived barriers were lack of time (67 %) and understanding (57 %), and concerns about generalizability of results (68 %). Identified facilitators included joint publication of HRQL/clinical outcomes (96 %) and summary of clinical implications of HRQL findings in RCT publications (76 %). Use of HRQL findings, perceived barriers/facilitators, and presentation preferences did not differ by country or specialty. Conclusions: Oncologists support HRQL findings from RCTs, but perceive important barriers to their use in clinical decision making, regardless of country or specialty. Combined, clear reporting of HRQL/clinical data may facilitate their clinical application. [ABSTRACT FROM AUTHOR]

Introduction: Few studies have evaluated interventions to improve quality of life (QOL) for Latina breast cancer survivors and caregivers. Following best practices in community-based participatory research (CBPR), we established a multi-level partnership among Latina survivors, caregivers, community-based organizations (CBOs), clinicians, and researchers to evaluate a survivor-caregiver QOL intervention. Methods: A CBO in the mid-Atlantic region, Nueva Vida, developed a patient-caregiver program called Cuidando a mis Cuidadores (Caring for My Caregivers), to improve outcomes important to Latina cancer survivors and their families. Together with an academic partner, Nueva Vida and three CBOs established a multi-level team of researchers, clinicians, Latina cancer survivors, and caregivers to conduct a national randomized trial to compare the patient-caregiver program to usual care. Results: Incorporating team feedback and programmatic considerations, we adapted the prior patient-caregiver program into an 8-session patient- and caregiver-centered intervention that includes skill-building workshops such as managing stress, communication, self-care, social well-being, and impact of cancer on sexual intimacy. We will measure QOL domains with the patient-reported outcomes measurement information system, dyadic communication between the survivor and caregiver, and survivors' adherence to recommended cancer care. To integrate the intervention within each CBO, we conducted interactive training on the protection of human subjects, qualitative interviewing, and intervention delivery. Conclusion: The development and engagement process for our QOL intervention study is innovative because it is both informed by and directly impacts underserved Latina survivors and caregivers. The CBPR-based process demonstrates successful multi-level patient engagement through collaboration among researchers, clinicians, community partners, survivors, and caregivers. [ABSTRACT FROM AUTHOR]

Purpose: Maintaining quality of life (QOL) and physical and mental health status are important outcomes throughout the aging process. Although cross-sectional studies suggest a relationship between global QOL and physical activity, it is unclear whether such a relationship exists as a function of exercise training. Methods: We examined the effects of two exercise intervention arms on health-related quality of life (HRQOL) and global QOL. Low-active, older adults ( n = 179) were randomly assigned to either a 12-month aerobic walking group or a strengthening and flexibility group. HRQOL and QOL were measured at baseline, 6, and 12 months. Results: There was a significant group by time effect on QOL [ F(2,176) = 3.11, p = 0.047, η = 0.03]. There was also a significant overall group by time effect for HRQOL [ F(4,174) = 2.46, p = 0.047, η = 0.05], which was explained by the significant group by time interaction for mental health status ( p = 0.041, η = 0.02) favoring the walking condition. Further analyses using latent class analysis revealed three classes of individuals with differential patterns of change in QOL and HRQOL across time. These classes reflected no change, declines, and improvements in these constructs across time. Conclusions: Walking appears to enhance the mental aspect of HRQOL and global QOL when compared to a non-aerobic intervention. Additionally, the patterns of change in QOL and HRQOL were not linear over time. Our findings are in contrast to previous reports that these outcomes change a little or not at all in randomized trials. [ABSTRACT FROM AUTHOR]

Purpose: Chronic heart failure (CHF) is not only a leading cause of death, hospitalization, and rehospitalization, but also significantly decreases quality of life (QoL). This study aims to evaluate published clinical trials of oral Chinese herbal medicine (OCHM) for improvement of QoL in patients with CHF that employ the Minnesota Living with Heart Failure Questionnaire (MLHFQ) score as an outcome measure. Methods: A systematic literature search was performed using five databases up to June 2013 to identify randomized control trials (RCTs). RCTs involving OCHM plus conventional medicine treatment (CMT) with or without blinding, compared with CMT with or without placebo, with MLHFQ score as an outcome measure were identified. The methodological quality of RCTs was assessed independently using the Cochrane Handbook for Systematic Review of Interventions. RevMan 5.2.5 and Stata 11.0 were used for data analysis. Results: Thirty-eight RCTs with a total of 3,170 participants were identified. The majority of the included trials were assessed to be of high clinical heterogeneity and poor methodological quality. The main results of meta-analysis showed improvement of total MLHFQ score when OCHM plus CMT compared with CMT with or without placebo [MD = −5.71 (−7.07, −4.36), p < 0.01]. Conclusions: There is some encouraging evidence of OCHM combined with CMT for the improvement of QoL in CHF patients. However, the evidence remains weak due to the small sample size, high clinical heterogeneity, and poor methodological quality of the included trials. Further, large sample size and well-designed trials are needed. [ABSTRACT FROM AUTHOR]

Purpose: Most breast cancer patients receive psychosocial support interventions. However, the effectiveness of these interventions has not yet been clarified. Quality of life (QOL) was an important construct that should be considered when assessing these interventions. The purpose was to evaluate the effectiveness of psychosocial and especially psychoeducational support interventions for early-stage breast cancer patients since the follow-up was bound up to 6 months after finishing the intervention. Methods: We conducted a systematic review and meta-analysis to identify randomized controlled trials with early-stage breast cancer patients receiving psychosocial (psychoeducational and other) support in which QOL was measured as a treatment outcome. We compared mean differences at less than 6 months post-intervention with a control group. The primary outcome was Global Health Status/QOL scale (Global QOL), and secondary outcomes were the subscales of QOL. Results: No significant effect was observed for Global QOL; however, individuals receiving psychosocial support scored higher on the Breast Cancer Symptoms subscale. For psychoeducational support in the psychosocial support, significant effect was observed on the Emotional subscale. Conclusions: Our analysis strengthens the evidence of the effectiveness of psychosocial support in improving breast cancer symptoms and psychoeducational support in improving emotional well-being within 6 months post-intervention. [ABSTRACT FROM AUTHOR]

Purposes: To investigate impact of participation in a supported employment program and impact of employment itself on health-related quality of life (HRQOL), disability, and handicap among Veterans with spinal cord injury (SCI). Methods: We used a prospective, randomized, controlled, multi-site trial of supported employment (SE) versus treatment as usual (TAU) for vocational issues. Subjects were 157 Veterans with SCI who received either SE or TAU for vocational issues. Outcomes were examined in terms of type of vocational treatment received and whether competitive employment was obtained. Outcomes investigated were HRQOL as measured by the Veterans RAND 36-item health survey (VR-36), handicap as measured by the Craig Handicap Assessment and Reporting Technique (CHART), and disability as measured by the functional independence measure (FIM). Subjects were assessed at baseline and at 3, 6, 9, and 12 months. Results: There were no significant differences between Veterans who participated in SE compared to those who received TAU in study measures. Participants obtaining competitive employment demonstrated significantly higher scores on the Social Integration, Mobility, and Occupation dimensions of the CHART. There were no observed differences in VR-36 scores or FIM scores for those obtaining competitive employment. Conclusion(s): This study suggests that employment has a positive effect on an individual’s ability to participate in social relationships, move about their home and community, and spend time in productive and usual roles. Inability to detect differences across other domains of handicap or any changes in HRQOL may have been due to several factors including level and intensity of employment, insufficient follow-up period, or measurement limitations. [ABSTRACT FROM AUTHOR]

Background: Health status has evolved as a clinical outcome measure that is of great interest in medical care. However, there is still debate about the appropriateness of scoring algorithms for the often used short form questionnaires. Therefore, our aim was to evaluate the consequences of the traditional scoring procedure based on orthogonal factor rotation for clinical applications by (a) re-evaluating the results of randomized controlled trials (RCTs) on the effectiveness of antidepressants in improving health status in cardiac patients and (b) comparing empirical evidence on depression and health status using orthogonal and oblique factor rotation (alternative scoring method) in a community sample and a heart failure (HF) sample. Methods: This is a systematic literature review and cross-sectional analysis among 1,598 community sample participants and 282 HF patients. Results: Orthogonal rotation artificially forces the mental component summary (MCS) and physical component summary (PCS) to be unrelated, which is illustrated in two of the three included RCTs. Two RCTs showed improvements in MCS, but no improvement in PCS over time. Cross-sectional analysis in the two datasets showed that employing the alternative scoring algorithm resulted in higher negative correlations of MCS and PCS with depression, and a gradual decline in MCS with each decile of decline in PCS. Conclusion: Our data showed that appropriate carefulness is needed when calculating and interpreting summary scores. The traditional scoring algorithm seems inappropriate to objectively evaluate the effects of interventions on both the MCS and the PCS. Awareness in the design and evaluation of interventions using these outcomes is warranted. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to estimate the effectiveness of patient education methods on quality of life and functional impairment of patients with schizophrenia. Methods: A multicentre, randomized controlled trial was carried out in two psychiatric hospitals in Finland from March 2005 to October 2007. A total of 311 patients with a diagnosis of schizophrenia, schizotypal disorder or delusional disorder were randomly allocated to computer-based patient education ( n = 100), conventional education with standard leaflets ( n = 106) and standard treatment ( n = 105). Participants were followed up 12 months later. Primary outcome was quality of life (Q-LES-Q-SF) and secondary outcome was functional disability (SDS). Analysis was performed by intention-to-treat. This study is registered, number ISRCTN74919979. Results: Patients' global quality of life improved and functional disability decreased significantly in all education groups over the follow-up time. There were no significant differences between groups in these outcomes. Conclusions: In light of the findings there is no evidence to support a particular education method as the best way to improve patients' quality of life or improve functional ability. On the other hand, no intervention was found to be harmful. Thus computer-based patient education may be a suitable alternative for some patients. While information technology will be more widely used in societies, computer-based intervention may be beneficial for some patients with serious mental disorders. [ABSTRACT FROM AUTHOR]

Purpose: This article reports on a mixed methods evaluation of a randomized control trial in Cleveland, Ohio, USA, that assessed whether an intergenerational volunteering intervention could enhance quality of life (QOL) for persons with mild to moderate dementia. Methods: Fifteen participants were randomized into intervention and control groups. The intervention group participated in hour-long volunteer sessions with a kindergarten class and an older elementary class in alternating weeks over a 5-month interval. Psychometric data on cognitive functioning, stress, depression, sense of purpose, and sense of usefulness were collected at baseline and at the close of the intervention, and change scores were computed and analyzed for all variables. Ethnography was carried out through the duration of the study, and narrative interviews were held with participants and caregivers. A modified grounded theory approach was used for qualitative analysis. Results: Quantitative analysis demonstrated a significant decrease in stress for the intervention group. Qualitative analysis identified three main pathways through which intergenerational volunteering affected QOL: perceived health benefits, sense of purpose and sense of usefulness, and relationships. Conclusions: Mixed methods evaluation demonstrated that intergenerational volunteering might enhance quality of life through several key pathways, most significantly reduced stress. [ABSTRACT FROM AUTHOR]

Background: To date, there is limited psychometric evidence on the Asthma Quality of Life Questionnaire (AQLQ12 +) among populations that include adolescents and adults. Objective: To provide evidence of the psychometric properties of the AQLQ12+ as a measure of asthma-specific quality of life (QOL) in patients with persistent asthma treated with a combination of inhaled glucocorticoid and long-acting beta2-agonist, as well as explore the predictors of at least a minimally important AQLQ12+ improvement. Methods: The psychometric properties of the AQLQ12+ were assessed through post hoc analysis of two large ( n = 740 and 778) Phase III, randomized, double-blinded, placebo-controlled efficacy studies of mometasone furoate/formoterol fumarate (MF/F) combination compared with monotherapy in subjects with persistent asthma previously treated with either low-dose or medium-dose inhaled glucocorticoids. Results: With 15% and 8% participation from 12- to 17-year olds, blinded trial data demonstrated excellent reproducibility (ICC range: 0.76-0.85) and moderate-to-strong construct validity with other measures of asthma health at baseline and over time for the AQLQ12 +. A greater percentage of the MF/F treatment group (44%) achieved an important change at 26 weeks on the AQLQ12+ compared with formoterol fumarate (F, 23%) and placebo (18%) treatment groups in the low-dose study ( P < 0.001) and the medium-dose study (50% (MF/F) versus 34% (F) and 23% (placebo); P < 0.001). Pre-randomization nighttime awakenings and rescue medications use were significant predictors of AQLQ12+ improvement. Conclusions: These findings provide strong support for the measurement properties of the AQLQ12+ among patients with persistent asthma and confidence in the AQLQ12+ improvements demonstrated by the MF/F treatment group. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to evaluate the internal and external responsiveness of the Short Musculoskeletal Function Assessment (SMFA), i.e. the instrument's ability to capture clinically important changes, in patients with hip fractures within the context of a randomized controlled trial. Methods: To evaluate the internal responsiveness of the SMFA, the observed change and the standardized response mean (SRM) in relation to the change in the Dysfunction Index and the Bother Index were calculated. In order to calculate external responsiveness, an external criterion (EC) was constructed by using the Harris hip score. Receiver operating characteristic (ROC) curves and logistic regression analysis were used in the evaluation. Results: Both the Bother and the Dysfunction SMFA indices displayed good internal responsiveness as expressed by significant change scores and by moderate and large SRMs, 0.76 and 0.96, respectively. The ROC curve and logistic regression analyses showed that both indices had acceptable external responsiveness and were able to discriminate between patients with a less good outcome versus a moderately good or good outcome based on the EC while the ability to differ between patients with moderately good versus a good outcome was limited. The percentage of correctly classified cases was 64% (good/moderately good), 80% (good/less good), and 74% (moderately good/less good) for both the Dysfunction and Bother Indices. Conclusions: The SMFA had good overall responsiveness in patients with hip fractures and, based on our results, we conclude that the SMFA can be recommended for use as one of the measures to evaluate the outcome after a hip fracture. [ABSTRACT FROM AUTHOR]

Purpose: To assess the diversity, application, analysis and interpretation of patient-reported outcomes (PROs) in asthma clinical trials. Methods: We critically appraised the use of asthma-specific PROs in 87 randomised controlled trials (RCTs) of inhaled asthma medications published during 1985-2006. Results: A total of 79 RCTs reported PROs, of which 78 (99%) assessed symptom scores and seven (9%) assessed asthma quality of life scores. Only eight (10%) used validated instruments and five (6%) provided clinical interpretation of scores. Due to heterogeneity in the reporting of symptom measures, it is not possible to determine how many discrete symptom assessment instruments have been used. Only 26 (33%) of the RCTs that measured symptom scores reported the scores for follow-up. Limited improvement occurred over time: fewer than 30% of the RCTs used validated PRO measures in any individual year. Conclusion: Numerous validated PRO instruments are available but it is unclear why few are used in asthma clinical trials. Problems include poor reporting, and uncritical analysis and interpretation of PRO scores. Research needs include identifying and recommending a set of PROs for use in asthma clinical research and providing guidance for researchers on the application, analysis and interpretation of PRO measures in clinical trials. [ABSTRACT FROM AUTHOR]

This randomized clinical equivalence trial was designed to evaluate health-related quality of life (HRQoL) after fast-track treatment for low-risk coronary artery bypass (CABG) patients. Four hundred and ten CABG patients were randomly assigned to undergo either short-stay intensive care treatment (SSIC, 8 h of intensive care stay) or control treatment (care as usual, overnight intensive care stay). HRQoL was measured at baseline and 1 month, and one year after surgery using the multidimensional index of life quality (MILQ), the EQ-5D, the Beck Depression Inventory and the State-Trait Anxiety Inventory. At one month after surgery, no statistically significant difference in overall HRQoL was found (MILQ-score P-value = .508, overall MILQ-index P-value = .543, EQ-5D VAS P-value = .593). The scores on the MILQ-domains, physical, and social functioning were significantly higher at one month postoperatively in the SSIC group compared to the control group ( P-value = .049; 95%CI: 0.01–2.50 and P-value = .014, 95% CI: 0.24–2.06, respectively). However, these differences were no longer observed at long-term follow-up. According to our definition of clinical equivalence, the HRQoL of SSIC patients is similar to patients receiving care as usual. Since safety and the financial benefits of this intervention were demonstrated in a previously reported analysis, SSIC can be considered as an adequate fast-track intensive care treatment option for low-risk CABG patients. [ABSTRACT FROM AUTHOR]

There is more than one effect of a randomized intervention, and more than one response to a treatment. The mean group difference in the pre-specified outcome of a randomized controlled trial (RCT) estimates the average causal effect of treatment across causal mechanisms that may be distinct. To understand the comprehensive impact of an intervention, we propose identifying and separating the direct causal effects of the intervention from mediating, moderating, and modulating (individual differences) influences of uncontrolled variables. Relational outcomes and moderated interventions describe two common mechanisms by which treatment interactions with uncontrolled variables expand or qualify the causal inferences to be drawn from an RCT, signifying treatment impact beyond that captured by conventional mean differences. Relational outcomes are associations between post-randomization measures. The treatment intervention may affect relational outcomes, and individual differences may modulate them. With moderated interventions, the effect of treatment on the outcome of interest depends on personal attributes or pre-randomization uncontrolled variables. Awareness and measurement of both types of mechanisms can greatly improve interpretation of the results of a clinical trial. The integrated formal system of Dynamically Modified Outcomes (DYNAMO) provides comprehensive analysis of the diverse causal influences and interactions operating in a clinical trial. [ABSTRACT FROM AUTHOR]

Many of us believe there are major benefits to be gained by using patient-reported outcomes (PROs) in routine clinical practice. However, demonstrating tangible benefits has frequently proved elusive. Although randomised clinical trials (RCTs) have become accepted as the standard for comparing alternative forms of clinical interventions, when evaluating the effectiveness of PROs there are a number of challenges both in terms of study design and the subsequent analysis. Despite this, to date, of those investigators who have used RCTs, relatively few have used anything other than simple two-group randomisation and comparisons. Most of these trials have also failed to demonstrate convincing benefits to patient outcomes. We suggest that the use of PROs may result in modest yet important improvements to patient outcomes, and that these benefits may be obscured in conventional individual patient trials because of contamination effects. The advantages of alternative designs such as cross-over studies and in particular cluster-randomised trials are illustrated. [ABSTRACT FROM AUTHOR]

To examine the effect of walking and vitamin B supplementation on quality-of-life (QoL) in community-dwelling adults with mild cognitive impairment. One year, double-blind, placebo-controlled trial. Participants were randomized to: (1) twice-weekly, group-based, moderate-intensity walking program ( n = 77) or a light-intensity placebo activity program ( n = 75); and (2) daily vitamin B pills containing 5 mg folic acid, 0.4 mg B12, 50 mg B6 ( n = 78) or placebo pills ( n = 74). QoL was measured at baseline, after six and 12 months using the population-specific Dementia Quality-of-Life (D-QoL) to assess overall QoL and the generic Short-Form 12 mental and physical component scales (SF12-MCS and SF12-PCS) to assess health-related QoL. Baseline levels of QoL were relatively high. Modified intention-to-treat analyses revealed no positive main intervention effect of walking or vitamin supplementation. In both men and women, ratings of D-QoL-belonging and D-QoL-positive affect subscales improved with 0.003 ( P = 0.04) and 0.002 points ( P = 0.06) with each percent increase in attendance to the walking program. Only in men, SF12-MCS increased with 0.03 points with each percent increase in attendance ( P = 0.08). Several small but significant improvements in QoL were observed with increasing attendance to the walking program. No effect of vitamin B supplementation was observed. International Standard Randomized Controlled Trial Number Register, 19227688, http://www.controlled-trials.com/isrctn/. [ABSTRACT FROM AUTHOR]

A brief visual analogue instrument was developed and tested in the context of a multicentre randomized double-blinded four-dose trial of megestrol acetate for the treatment of AIDS-related anorexia/cachexia. This nine-item instrument, the Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI), was administered every 4 weeks after initiation of study drug (placebo vs 100 mg, 400 mg or 800 mg of drug). The purpose of the instrument was to quantify patient perception of benefit in areas such as decreased concern over weight, decreased concern over appearance, increased pleasure in eating and increase in global perception of quality of life. Post-trial psychometric evaluation of the instrument strongly supported the use of a seven-item index of subjective recovery from symptoms of anorexia/cachexia (BACRI-7) and a single criterion item depicting patient perception of benefit (BACRI-1). The BACRI-7 and BACRI-1 scales showed significant improvement over 12 weeks in patients who received higher dose active drug (400 and 800 mg) compared with the placebo and 100 mg doses. Further differentiation of 400 vs 800 mg arms was seen in the BACRI-7 results, consistent with dose-response improvements in weight and lean body mass changes. Quadratic trends over time in lean body mass change and provider-rated appetite grade suggested peak therapeutic effect at 8 weeks for these endpoints, whereas the absence of these trends in overall weight and patient-reported BACRI scores suggested that these benefits are more persistent. Although subjective (patient-reported) benefit is strongly associated with objective indicators of improvement, there remains the possibility that there is some added, independent benefit of megestrol acetate to subjective well-being. [ABSTRACT FROM AUTHOR]

In clinical trials with a quality of life (QoL) component, it is usual to monitor several QoL dimensions at several points in time. Multiple significance tests without formal hypotheses are problematic. It is not always feasible to specify a priori hypotheses for all variables. Can such studies be used to generate hypotheses for testing in later research only? We developed a method which can allow for formal hypothesis testing on a data set collected without a priori hypotheses in the protocol. We surveyed experienced physicians and nurses treating patients, to obtain independent expectations about differences in QoL dimensions. These ’staff expectations‘ will be used in the analysis of QoL data collected from breast cancer patients taking part in three randomized trials of adjuvant therapy. We propose frameworks for the informal and formal use of the experience of the staff in testing for group differences in patients‘ QoL scores. The method described here is anticipated to be useful for QoL studies in general, even when a priori hypotheses were specified before the studies were initiated. [ABSTRACT FROM AUTHOR]