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Introduction: This study evaluated patients' experiences with fluticasone furoate/vilanterol (FF/VI) combination therapy in UK patients with asthma or chronic obstructive pulmonary disease (COPD).Methods: Participants aged ≥ 18 years, with self-reported, physician-diagnosed asthma or COPD (≥ 1 year) who had been receiving FF/VI (≥ 3 months) were recruited from UK primary care. This two-phase, mixed-methods study consisted of a semi-structured, telephone-interview phase (qualitative) and a self-completed online/paper-survey phase (quantitative).Results: The telephone-interview phase included 50 individuals [asthma, n = 25; COPD, n = 25; mean age (SD) 56.7 years (13.3); 50% female]. Of these, 21 with asthma reported that their condition was stable/well controlled and 13 with COPD felt their condition was manageable. Most participants found FF/VI easy to use (asthma, 25; COPD, 23), easy to integrate into their daily routine (asthma, 25; COPD, 24), and able to control symptoms for ≥ 24 h (asthma, 14; COPD, 16). During the survey phase, 199 individuals were recruited [asthma, n = 100; COPD, n = 99; mean age (SD) 63.6 years (15.1); 59.3% female]. Most participants were satisfied/very satisfied with the efficacy of FF/VI in terms of all-day symptom relief (asthma, 84%; COPD, 75%) and found FF/VI easy/very easy to fit into their daily routine (asthma, 99%; COPD, 96%), easy/very easy to use (asthma, 97%; COPD, 92%), and convenient/very convenient to take as instructed (asthma, 95%; COPD, 93%). Significantly more individuals with asthma (87% versus 46%, P < 0.001) and numerically more individuals with COPD (84% versus 76%, P = 0.055) were satisfied/very satisfied with FF/VI compared with their most recent previous maintenance medication.Conclusion: The majority of individuals in this study had confidence in FF/VI and were satisfied or very satisfied with various key attributes of the treatment.Trial Registration: GSK study HO-15-15503/204888.Funding: GSK. [ABSTRACT FROM AUTHOR]

Purpose: This paper evaluated the impact of cleft-related surgery on the oral health-related quality of life (OHRQoL) of youth with cleft over time.Methods: Data were derived from a 5-year, multi-center, prospective, longitudinal study of 1196 youth with cleft lip and/or palate and their caregivers. Eligible youth were between 7.5 and 18.5 years old, spoke English or Spanish, and were non-syndromic. During each observational period, which included baseline, and 1- and 2-year post-baseline follow-up visits, youths and their caregivers completed the Child Oral Health Impact Profile, a validated measure of OHRQoL. Multilevel mixed-effects models were used to analyze the effects of receipt of craniofacial surgery on OHRQoL over time.Results: During the course of this study a total of 516 patients (43 %) received at least one surgery. Youth in the surgery recommendation group had lower self- (β = -2.18, p < 0.05) and proxy-rated (β = -2.92, p < 0.02) OHRQoL when compared to non-surgical self- and proxy-rated OHRQoL at baseline. Both surgical and non-surgical youth (β = 3.73, p < 0.001) and caregiver (β = 1.91, p < 0.05) ratings of OHRQoL improved over time. There was significant incremental improvement (time × surgery interaction) in self-reported OHRQoL for youth postsurgery (β = 1.04, p < 0.05), but this postsurgery increment was not seen in the caregiver proxy ratings.Conclusions: Surgical intervention impacts OHRQoL among youth with cleft. Youth who were surgical candidates had lower baseline self- and caregiver-rated OHRQoL when compared to non-surgical youth. Youth who underwent cleft-related surgery had significant incremental improvements in self-rated but not caregiver (proxy)-rated OHRQoL after surgery. [ABSTRACT FROM AUTHOR]

Purpose: We describe 7 years of follow-up for the energy/vitality outcome in early-stage Hodgkin's disease patients treated on a randomized clinical trial that compared subtotal lymphoid irradiation (STLI) with combined modality treatment (CMT) (SWOG 9133). Survivorship research questions involved the extent to which symptoms/side effects endured over a follow-up period of 7 years for this early-stage patient group.Methods: Two hundred thirty-nine patients participated in the quality of life (QOL) companion study (SWOG 9208) and completed the SF-36 vitality scale, SF-36 health perception item, Cancer Rehabilitation Evaluation System-Short Form (CARES-SF), and symptom distress scale. This paper reports vitality outcome results obtained from randomization, 6 months, and annually for 7 years. To assess changes in vitality over time, we used linear mixed models with patient as a random effect.Results: Patients receiving CMT had lower observed vitality at 6 months than did the STLI patients (p < .0001). However, beginning at year 1, vitality results did not differ significantly by treatment over the 5-year (p = .13) and 7-year (p = .16) follow-up periods. Vitality only slightly improved over baseline in either group after treatment. The results were similar after accounting for patterns of recurrence and missing data.Conclusions: This study demonstrated that patients with early-stage Hodgkin's disease experience a short-term (at 6 months) decrease in vitality with treatment, which is more severe with CMT, but that after the first year, vitality scores were similar between the two treatment groups. Enduring fatigue results for patients receiving these therapies were not observed. Implications for cancer survivors These data provide comprehensive 7-year follow-up vitality information, an important symptom for early-stage lymphoma survivors. [ABSTRACT FROM AUTHOR]

Purpose: The macular degeneration quality of life (MacDQoL) instrument is a validated condition-specific measure of quality of life in patients with macular degeneration. This paper presents the first mapping algorithm to predict EQ-5D from responses to the MacDQoL instrument.Methods: Responses to the MacDQoL and EQ-5D-3L instruments from 482 patients were collected from the IVAN multicentre trial of two alternative drug treatments for neovascular age-related macular degeneration. Regression specifications were estimated using OLS, censored least absolute deviation, Tobit and two-part models. Their predictive performance was assessed using mean squared error. An internal validation sample based on a random selection of 25 % of patients was used to assess the performance of the model estimated on the remaining 75 % of patients.Results: A two-part model had the best predictive performance on the full sample. The covariates of this model include responses and weighted impact scores for all 23 condition-specific domains of the MacDQoL, and responses to a general MacDQoL quality of life question. The selected models were successful at predicting means and standard deviations of target populations, but prediction is weaker at the upper and lower extremes of the EQ-5D-3L distribution.Conclusion: The mapping algorithms provide a means of predicting EQ-5D-3L index scores from MacDQoL scores, and could facilitate cost-effectiveness analyses when the latter but not the former are available to researchers. Further validation of the performance of the algorithms using external data would provide a means of establishing the robustness of the algorithms. [ABSTRACT FROM AUTHOR]

Purpose: User-generated content on social media sites, such as health-related online forums, offers researchers a tantalizing amount of information, but concerns regarding scientific application of such data remain. This paper compares and contrasts symptom cluster patterns derived from messages on a breast cancer forum with those from a symptom checklist completed by breast cancer survivors participating in a research study.Methods: Over 50,000 messages generated by 12,991 users of the breast cancer forum on MedHelp.org were transformed into a standard form and examined for the co-occurrence of 25 symptoms. The k-medoid clustering method was used to determine appropriate placement of symptoms within clusters. Findings were compared with a similar analysis of a symptom checklist administered to 653 breast cancer survivors participating in a research study.Results: The following clusters were identified using forum data: menopausal/psychological, pain/fatigue, gastrointestinal, and miscellaneous. Study data generated the clusters: menopausal, pain, fatigue/sleep/gastrointestinal, psychological, and increased weight/appetite. Although the clusters are somewhat different, many symptoms that clustered together in the social media analysis remained together in the analysis of the study participants. Density of connections between symptoms, as reflected by rates of co-occurrence and similarity, was higher in the study data.Conclusions: The copious amount of data generated by social media outlets can augment findings from traditional data sources. When different sources of information are combined, areas of overlap and discrepancy can be detected, perhaps giving researchers a more accurate picture of reality. However, data derived from social media must be used carefully and with understanding of its limitations. [ABSTRACT FROM AUTHOR]

In this paper, we explore hope in the context of living with chronic pain. Individuals with chronic pain from temporomandibular disorder(s) were interviewed four to five times over the course of their 18-month participation in a clinical trial investigating the effectiveness of Traditional Chinese Medicine. We sought to understand shifts in participants' descriptions of expectations and hopefulness, particularly with regard to the work involved in counterbalancing positive thinking with buffers against disappointment. We found hope to be a dynamic and multifaceted mindset as distinct from being a single entity to be measured. Drawing upon Polanyi's concept of tacit knowing, we explore how different ways of hoping emerge and index one another in participant narratives. We offer a working typology of hope and raise as an issue the manner in which the paradox of hope--hoping enough to carry on while keeping hopes in check to avoid the ever-present possibility of despair--complicates simplistic notions of the relationship between positive thinking and the placebo response. [ABSTRACT FROM AUTHOR]

Background: Early and integrated specialized palliative care is often recommended but has still only been investigated in relatively few randomized clinical trials.Objective: To investigate the effect of early specialized palliative care plus standard care versus standard care on the explorative outcomes in the Danish Palliative Care Trial (DanPaCT).Methods: We conducted a randomized multicentre, parallel-group clinical trial. Consecutive patients with metastatic cancer were included if they had symptoms or problems that exceeded a predefined threshold according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Outcomes were estimated as the differences between the intervention and the control groups in the change from baseline to the weighted mean of the 3- and 8-week follow-ups measured as areas under the curve.Results: In total, 145 patients were randomized to early specialized palliative care plus standard care versus 152 to standard care only. Early specialized palliative care had no significant effect on any of the symptoms or problems. Of the 21 items addressing satisfaction, specialized palliative care improved the item 'overall satisfaction with the help received from the health care system' with 9 points (95% confidence interval 3.8 to 14.2, p = 0.0006) and three other items (all p < 0.05).Conclusion: In line with the analyses of the primary and secondary outcomes in DanPaCT, we did not find that specialized palliative care, as provided in DanPaCT, affected symptoms and problems. However, patients in the intervention group seemed more satisfied with the health care received than those in the standard care group.Trial Registration: NCT01348048. [ABSTRACT FROM AUTHOR]

Objectives: To compare patient satisfaction, procedural variables, and safety with transradial access (TRA) and transfemoral access (TFA) in patients undergoing transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC).Materials and Methods: From February 2019 to August 2021, 130 patients undergoing TACE for HCC were randomly allocated to the TRA (n = 65) or TFA (n = 65) group. Vascular closure devices were not used after TFA-TACE. All patients completed the post-catheterization questionnaire and 8-item Short-Form Health Survey 1 day after TACE.Results: Technical success rate, crossover rate, contrast agent dose, fluoroscopy time, procedure time, air kerma, dose-area product, length of hospital stay, and total cost were similar between the two groups (all p > 0.05). The incidence and severity of adverse events were also similar between the two groups (all p > 0.05). However, overall discomfort, difficulty going to the bathroom, difficulty feeding or self-caring, difficulty walking, general health, physical function, role physical function, social function, mental health, and role emotional function were better in the TRA group than in the TFA group (all p < 0.001). Consequently, more patients preferred the current access for their next procedure in the TRA group than in the TFA group (90.8% vs. 24.6%; p < 0.001).Conclusion: In patients undergoing TACE for HCC, using TRA instead of TFA can improve patient satisfaction without compromising procedural variables and safety.Key Points: • Transradial access (TRA) enabled early ambulation after transarterial chemoembolization (TACE), resulting in significant increase in activities of daily living and health-related quality of life (HRQoL) compared to transfemoral access (TFA) when vascular closure devices were not used. • Procedural variables (contrast agent dose, fluoroscopy time, procedure time, air kerma, dose-area product, length of hospital stay, and total cost) were not significantly different between patients who received TRA-TACE and TFA-TACE. • The incidence and severity of adverse events were similar between patients who received TRA-TACE and TFA-TACE. [ABSTRACT FROM AUTHOR]

Purpose: Behavioral interventions have been used with breast cancer survivors (BCS) in cancer pain management and post-treatment quality of life (QOL) studies. We studied the effects of an anti-inflammatory dietary intervention on QOL in BCS.Methods: One hundred fifty-three overweight and obese (body mass index [BMI] ≥ 25 kg/m2), early stage (0-III), English-speaking BCS who had completed all cancer treatment 2 or more months prior to enrollment were recruited into a two-arm randomized controlled trial with a 2 (group) by 3 (time) repeated measures design. Intervention components included six monthly food-preparation workshops and twelve motivational interviewing telephone calls. Endpoints included the Perceived Stress Scale (PSS), the Functional Assessment of Cancer Therapy-General (FACT-G) and Breast Cancer (FACT-B), and the Center for Epidemiologic Studies Depression Scale (CES-D). Repeated measures analysis using PROC MIXED in SAS version 9.4 was used.Results: On repeated measures analysis (intent to treat), there were no differences between groups on any of the QOL outcomes except the PSS total scores. These were significantly different in the intervention group (IG; n = 76) compared to control group (CG; n = 77), showing a main effect of assignment but no effect of time and no interaction effects.Conclusion: There was an impact on QOL as measured by the PSS between groups. The intervention reduced perceived stress at 6-month follow-up, but the effects dissipated by 12 months. Sources and stress and stress reduction should be a focus of future studies. Future research should also identify appropriate QOL measures that are sensitive to changes brought about by behavioral interventions. [ABSTRACT FROM AUTHOR]

Background: CRC-PIPAC prospectively assessed repetitive oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy (PIPAC-OX) as a palliative monotherapy (i.e., without concomitant systemic therapy in between subsequent procedures) for unresectable colorectal peritoneal metastases (CPM). The present study explored patient-reported outcomes (PROs) during trial treatment.Methods: In this single-arm phase 2 trial in two tertiary centers, patients with isolated unresectable CPM received 6-weekly PIPAC-OX (92 mg/m2). PROs (calculated from EQ-5D-5L, and EORTC QLQ-C30 and QLQ-CR29) were compared between baseline and 1 and 4 weeks after the first three procedures using linear mixed modeling with determination of clinical relevance (Cohen's D ≥ 0.50) of statistically significant differences.Results: Twenty patients underwent 59 procedures (median 3 [range 1-6]). Several PROs solely worsened 1 week after the first procedure (index value - 0.10, p < 0.001; physical functioning - 20, p < 0.001; role functioning - 27, p < 0.001; social functioning - 18, p < 0.001; C30 summary score - 16, p < 0.001; appetite loss + 15, p = 0.007; diarrhea + 15, p = 0.002; urinary frequency + 13, p = 0.004; flatulence + 13, p = 0.001). These PROs returned to baseline at subsequent time points. Other PROs worsened 1 week after the first procedure (fatigue + 23, p < 0.001; pain + 29, p < 0.001; abdominal pain + 32, p < 0.001), second procedure (fatigue + 20, p < 0.001; pain + 21, p < 0.001; abdominal pain + 20, p = 0.002), and third procedure (pain + 22, p < 0.001; abdominal pain + 22, p = 0.002). Except for appetite loss, all changes were clinically relevant. All analyzed PROs returned to baseline 4 weeks after the third procedure.Conclusions: Patients receiving repetitive PIPAC-OX monotherapy for unresectable CPM had clinically relevant but reversible worsening of several PROs, mainly 1 week after the first procedure.Trial Registration: Clinicaltrials.gov: NCT03246321; Netherlands trial register: NL6426. [ABSTRACT FROM AUTHOR]

Because depressive symptoms are a part of health-related quality-of-life (HRQOL) measures, measures of depression will be empirically associated with HRQOL. We discuss examples of published research where authors ignored or did not fully account for overlap between depressive symptom and HRQOL measures. Future researchers need to recognize when their models include conceptually similar variables on the same side or both sides of the equation. This awareness will lead to more accurate conclusions about the prognostic value of depression and other HRQOL measures for health care utilization, mortality, and other outcomes. It will also result in fewer incorrect claims about the effect of depression on HRQOL. [ABSTRACT FROM AUTHOR]

Purpose: For adult spinal deformity (ASD) patients receiving operative (op) and non-operative (non-op) treatment, the relationship between HRQoL measures, complications and self-reported satisfaction remains unclear. The objective of this analysis is to study nonlinear association dynamics between ASD patient satisfaction, HRQoL, and complications over a two-year follow-up period.Methods: From a prospective multicenter international adult spinal deformity database, all patients with 2-year follow-up data on satisfaction (21st question of SRS-22r) were identified and included. A total of 12 LOESS (local polynomial fit) regressions were performed between patient satisfaction (SRS22 item 21) and HRQoL measures (ODI, SF36PCS and SRS22 subtotal) interacting with surgery at baseline, 6 months and 1 and 2 years of follow-up.Results: A total of 856 patients (527 op and 329 non-op) were included. At baseline, satisfaction was lower for patients scheduled for surgery even when HRQL was similar to those elected for conservative treatment. The nonlinear correlations showed that for similar PROMs, op patients reached higher satisfaction levels during follow-up, especially at six months. In fact, at six months operated patients with a deterioration of their initial PROMs had some improvement in their satisfaction, which could not be further observed at the end of follow-up.Conclusions: Satisfaction does not correlate well with other PROMs, and it might be subject to other external factors not directly related to treatment. Even if patient satisfaction is important in evaluating well-being and patient's experience with medical care, it should not be considered as an isolated proxy to measure quality of treatment. [ABSTRACT FROM AUTHOR]

Purpose: It is not yet known if unicompartmental knee arthroplasty (UKA) patients are more likely to return to work sooner or have improved ability to work (i.e., workability) than total knee arthroplasty (TKA) patients. The following questions were addressed: patients were assessed to determine: (1) whether they returned to work sooner following UKA compared to TKA; (2) whether UKA patients had better WORQ function scores compared to TKA patients; and (3) if UKA patients have higher workability scores and greater satisfaction regarding workability than TKA patients.Methods: A multicenter retrospective cohort study was performed that included patients at least 2 years after having undergone either UKA or TKA surgery and on the condition that patients had been in work in the 2 years prior to surgery. Time period between stopping work and returning to work was assessed; the WORQ scores (0 = worst-100 = best) and the Work Ability Index (WAI = 0-10) and reported satisfaction with work ability.Results: UKA patients (n = 157, median 60 years, 51% male) were compared to TKA patients (n = 167, median 60 years, 49% male) (n.s.). Of the 157 UKA patients, 115 (73%) returned to work within 2 years compared to 121 (72%) of TKA patients (n.s.). More UKA patients return to work within 3 months (73% versus 48%) (p < 0.01). WORQ scores improved similarly in both groups. The WAI was also comparable between the groups. Dissatisfaction with workability was comparable (UKA 15% versus TKA 18% (n.s.).Conclusion: TKA and UKA patients have similar WORQ, WAI, and satisfaction scores. However, in this study population, UKA patients to return to work after surgery significantly sooner than TKA patients, which improves their quality of life and allows them to participate actively in society. This information can help health care providers and patients weigh-up the pros and cons and choose the best treatment and timing for patients in the working population.Level Of Evidence: III. [ABSTRACT FROM AUTHOR]

Premature ejaculation (PE) is associated with decreased quality of life, lower confidence and self-esteem, and higher levels of depression, anxiety, and interpersonal difficulties. Here we investigated the effectiveness of vibrator-assisted start-stop exercises for treatment of PE, and whether the treatment effect could be enhanced by an additional psychobehavioral intervention. Fifty participants with a mean age of 41.7 years were included and randomized into two treatment groups and a waiting list control group. Participants were instructed to perform start-stop exercises while stimulating the penis with a purpose-made vibrator, 3 times a week for 6 weeks. Additionally, participants in one of the treatment groups received additional psychoeducation and performed mindfulness meditation-based body scan exercises three times a week. Data were gathered through online questionnaires before and after treatment, as well as 3 and 6 months after treatment. The interventions reduced PE symptoms with large effect sizes (partial η2 = .20 across the three groups, d [95% CI] = 1.05 [.27, 1.82] and 1.07 [.32, 1.82] for treatment groups compared to waiting list control group). The additional psychobehavioral intervention did not further reduce PE symptoms, but did decrease PE-associated negative symptoms such as levels of sexual distress, anxiety, and depression. No side effects were reported. Vibrator-assisted start-stop exercises can be offered as an adequate treatment option for PE. [ABSTRACT FROM AUTHOR]

Purpose: Radiotherapy to the prostate gland and pelvic lymph nodes may cause acute and late bowel symptoms and diminish quality of life. The aim was to study the effects of a nutrition intervention on bowel symptoms and health-related quality of life, compared with standard care.Methods: Patients were randomised to a nutrition intervention (n = 92) aiming to replace insoluble fibres with soluble and reduce intake of lactose, or a standard care group (n = 88) who were recommended to maintain their habitual diet. Bowel symptoms, health-related quality of life and intake of fibre and lactose-containing foods were assessed up to 24 months after radiotherapy completion. Multiple linear regression was used to analyse the effects of the nutrition intervention on bowel symptoms during the acute (up to 2 months post radiotherapy) and the late (7 to 24 months post radiotherapy) phase.Results: Most symptoms and functioning worsened during the acute phase, and improved during the late phase in both the intervention and standard care groups. The nutrition intervention was associated with less blood in stools (p = 0.047), flatulence (p = 0.014) and increased loss of appetite (p = 0.018) during the acute phase, and more bloated abdomen in the late phase (p = 0.029). However, these associations were clinically trivial or small.Conclusions: The effect of the nutrition intervention related to dietary fibre and lactose on bowel symptoms from pelvic RT was small and inconclusive, although some minor and transient improvements were observed. The results do not support routine nutrition intervention of this type to reduce adverse effects from pelvic radiotherapy. [ABSTRACT FROM AUTHOR]

Purpose: The causal link between chemotherapy and cognitive impairment is unclear. We studied testicular cancer patients' objective and subjective cognitive function longitudinally, comparing a surgery group with a surgery + chemotherapy group, addressing prior methodological issues using a computerized test to limit assessment issues, and controlling for confounding variables.Methods: Prospectively, of 145 patients from 16 centres with sufficient data, n = 61 receiving surgery + chemotherapy (etoposide and cisplatin ± bleomycin, BEP/EP; or single agent carboplatin) were compared to n = 41 receiving surgery alone. CogHealth assessed six objective cognitive tasks. The Cognitive Failures Questionnaire assessed self-perceived cognitive dysfunction. The Functional Assessment of Chronic Illness Therapy-Fatigue and the Hospital Anxiety and Depression Scale assessed psychological influences. Linear mixed models compared changes from baseline (< 6 months post-surgery/pre-chemotherapy) to follow-up (12-18 months post-baseline), controlling covariates.Results: There were no significant interaction effects for five objective cognitive function tasks suggesting that changes over time were not due to group membership. However, psychomotor function (controlling for age) and physical well-being were significantly worse for the chemotherapy versus the surgery group at baseline, with groups converging by follow-up. Groups showed no differences in subjective cognitive dysfunction. The chemotherapy group showed higher anxiety, poorer functional well-being and worse fatigue compared to the surgery-only group at baseline, but not by follow-up. For both groups, emotional well-being, functional well-being and anxiety significantly improved over time.Conclusion: No substantive differences in objective or subjective cognitive dysfunction in either group persisted 12-18 months post-baseline. Patients undergoing chemotherapy for testicular cancer differ from findings in breast cancer populations.Trial Registration: ClinicalTrials.gov Identifier: ACTRN12609000545268. [ABSTRACT FROM AUTHOR]

Background: On July 1, 2018, the Veterans Health Administration (VA) National Center for Ethics in Health Care implemented the Life-Sustaining Treatment Decisions Initiative (LSTDI). Its goal is to identify, document, and honor LST decisions of seriously ill veterans. Providers document veterans' goals and decisions using a standardized LST template and order set.Objective: Evaluate the first 7 months of LSTDI implementation and identify predictors of LST template completion.Design: Retrospective observational study of clinical and administrative data. We identified all completed LST templates, defined as completion of four required template fields. Templates also include four non-required fields. Results were stratified by risk of hospitalization or death as estimated by the Care Assessment Need (CAN) score.Subjects: All veterans with VA utilization between July 1, 2018, and January 31, 2019.Main Measures: Completed LST templates, goals and LST preferences, and predictors of documentation.Results: LST templates were documented for 108,145 veterans, and 85% had one or more of the non-required fields completed in addition to the required fields. Approximately half documented a preference for cardiopulmonary resuscitation. Among those who documented specific goals, half wanted to improve or maintain function, independence, and quality of life while 28% had a goal of life prolongation irrespective of risk of hospitalization/death and 45% expressed a goal of comfort. Only 7% expressed a goal of being cured. Predictors of documentation included VA nursing home residence, older age, frailty, and comorbidity, while non-Caucasian race, rural residence, and receipt of care in a lower complexity medical center were predictive of no documentation.Conclusions: LST decisions were documented for veterans at high risk of hospitalization or death. While few expressed a preference for cure, half desire, cardiopulmonary resuscitation. Predictors of documentation were generally consistent with existing literature. Opportunities to reduce observed disparities exist by leveraging available VA resources and programs. [ABSTRACT FROM AUTHOR]

Background: The measurement and valuation of health-related quality of life for and by young people are increasingly important, yet research on the impact of study perspective and validity of preferences obtained from young populations remains limited.Objective: The objective of this study was to evaluate the feasibility and validity of collecting EQ-5D Youth version (EQ-5D-Y) preferences from adolescents, adults, and adults from a child perspective.Methods: A profile case best-worst scaling (BWS) online survey was administered to representative Australian and Spanish adult (age ≥ 18 years) and child (age 11-17 years) samples. Adults were told to either answer from their own perspective or for a hypothetical 10-year-old child. Marginal best- and worst-choice frequencies, analysis of dominant choices, self-reported difficulty completing the tasks, and time to complete tasks were used to determine the validity of responses.Results: In Australia, 2134 adults and 1010 adolescents completed the survey. In Spain, 2007 adults and 1000 adolescents completed it. Analysis of marginal choice frequencies and dominant choices indicated that the pattern of responses between adolescents and adults was similar. For Australian respondents, having no mobility problems was rated as best by adolescents, while adults rated having no pain and discomfort as 'best'. In Spain, both adults and adolescents rated no pain or discomfort as 'best'. Australian adolescents rated very worried, sad or unhappy as 'worst', while Spanish adolescents, Spanish adults and Australian adults rated a lot of pain and discomfort as 'worst'.Conclusions: Results suggest preferences from adolescents using direct BWS are valid. Our descriptive analysis also suggest that there are age-related and country-specific differences in elicitation values for the EQ-5D-Y. [ABSTRACT FROM AUTHOR]

The Sarcopenia and Quality of Life questionnaire (SarQol®) is a self-administered multidimensional sarcopenia-specific tool designed for community-dwelling subjects aged 65 years and older. The purpose of the present study was to evaluate the psychometric properties of the Spanish version of the SarQoL®. A total of 252 participants aged ≥ 65 years voluntarily participated in this cross-sectional study. Handgrip strength and bioelectrical impedance analysis were used for sarcopenia screening. Discriminative power, internal consistency, test-retest reliability, and floor and ceiling effects were analyzed. The generic 36-item Short-Form Health Survey (SF-36), the European Quality of Life 5-Dimension-3 Level (EQ-5D-3L), and the Hospital Anxiety and Depression Scale (HADS) were also used for convergent and divergent validity. Significant differences between sarcopenic (n = 66) and non-sarcopenic participants were observed for SarQoL® total score (p = 0.008) and for all domains except D2-locomotion. A high internal consistency of SarQoL® total score (Cronbach's alpha = 0.904) was found, and significant domain-to-total score correlations were obtained (all p < .001). Test-retest data showed excellent reliability for SarQoL® total score (ICC = 0.99; 95%CI 0.98-0.99) and in all dimensions, except for D6-leisure and D7-fears activities (substantial). No floor and ceiling effects were observed for SarQoL® total score. SarQoL® total score showed good and acceptable correlations(p < 0.001) with the selected domains of the SF-36 and EQ-5D-3L which have similar dimensions (convergent validity). Low and non-significant correlations existed with anxiety, depression, and EQ-5D-3L self-care and pain/discomfort domains (divergent validity). The Spanish SarQoL® shows satisfactory general psychometric properties in Spanish-speaking older adults from Spain and is able to discriminate between older adults with and without sarcopenia. [ABSTRACT FROM AUTHOR]

Objectives: To investigate the efficacy and safety of a new portable ultrasound-guided high-intensity focused ultrasound system (USgHIFU) with advanced targeting and beam steering technology for the treatment of uterine fibroids.Methods: Fifty-nine uterine fibroids from 36 participants (mean age, 44.9 ± 4.1 years) were included from November 2013 to November 2015. All participants were treated with HIFU, with 3D electronic steering. MR imaging studies were performed before HIFU, immediately after HIFU, and 1 month and 3 (or 5) months after the HIFU treatment. The non-perfused volume ratio (NPVR), fibroid volume shrinkage (FVS), symptom improvement, quantified life quality assessment, and safety were analyzed. A long-term follow-up was conducted in July to December 2017 (mean, 32.2 months).Results: The volume of the treated uterine fibroids ranged from 7.5 to 274.4 cm3 (mean, 69.8 cm3; SD, 64.3 cm3). The mean NPVR on the immediate post-HIFU MR imaging was 74.8 ± 25.2%. The mean FVS was 17.3% at 1 month, 33.3% at 3 months, and 45.1% at 5 months after HIFU treatment. The mean treatment time was 44.6 ± 28.2 min per fibroid and 72.9 ± 31.4 min per participant. Uterine fibroid-related symptoms and quality of life showed statistically significant improvement after the HIFU treatment. No significant symptoms related to safety or complications occurred. In the long-term follow-up, 78.8% of those surveyed were satisfied with their HIFU treatment.Conclusion: This clinical trial showed that a portable USgHIFU with advanced functions may safely and effectively treat uterine fibroids.Key Points: • A portable compact ultrasound-guided high-intensity focused ultrasound (HIFU) can effectively and safely treat uterine fibroids. • Advanced functions, such as portability, targeted forecasting, electronic beam steering, and interleaved scanning, might be helpful in enhancing the clinical applicability of ultrasound-guided high-intensity focused ultrasound. • In the long-term follow-up of more than 2 years, approximately 80% of those surveyed were satisfied with their HIFU treatment. [ABSTRACT FROM AUTHOR]

Background: Poor sleep is common among adults with chronic low back pain (cLBP), but the influence of cLBP treatments, such as yoga and physical therapy (PT), on sleep quality is under studied.Objective: Evaluate the effectiveness of yoga and PT for improving sleep quality in adults with cLBP.Design: Secondary analysis of a randomized controlled trial.Setting: Academic safety-net hospital and 7 affiliated community health centers.Participants: A total of 320 adults with cLBP.Intervention: Twelve weekly yoga classes, 1-on-1 PT sessions, or an educational book.Main Measures: Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI) global score (0-21) at baseline, 12 weeks, and 52 weeks. Additionally, we also evaluated how the proportion of participants who achieved a clinically meaningful improvement in sleep quality (> 3-point reduction in PSQI) at 12 weeks varied by changes in pain and physical function at 6 weeks.Key Results: Among participants (mean age = 46.0, 64% female, 82% non-white), nearly all (92%) reported poor sleep quality (PSQI > 5) at baseline. At 12 weeks, modest improvements in sleep quality were observed among the yoga (PSQI mean difference [MD] = - 1.19, 95% confidence interval [CI] - 1.82, - 0.55) and PT (PSQI MD = - 0.91, 95% CI - 1.61, - 0.20) groups. Participants who reported a ≥ 30% improvement in pain or physical function at 6 weeks, compared with those who improved < 10%, were more likely to be a sleep quality responder at 12 weeks (odds ratio [OR] = 3.51, 95% CI 1.73, 7.11 and OR = 2.16, 95% CI 1.18, 3.95, respectively). Results were similar at 52 weeks.Conclusion: In a sample of adults with cLBP, virtually all with poor sleep quality prior to intervention, modest but statistically significant improvements in sleep quality were observed with both yoga and PT. Irrespective of treatment, clinically important sleep improvements at the end of the intervention were associated with mid-intervention pain and physical function improvements.Trial Registration: ClinicalTrials.gov Identifier: NCT01343927. [ABSTRACT FROM AUTHOR]

Purpose: We designed a novel, manualized intervention called Emotion And Symptom-focused Engagement (EASE) for acute leukemia (AL) and report here on a phase II randomized controlled trial (RCT) to assess its feasibility and preliminary efficacy.Methods: Patients were recruited within 1 month of hospital admission and randomized to EASE plus usual care (UC) or UC alone. EASE includes (1) EASE-psy, a tailored psychotherapy delivered over 8 weeks, and (2) EASE-phys, weekly physical symptom screening over 8 weeks to trigger early palliative care. The primary outcome was traumatic stress symptoms; secondary outcomes included physical symptom burden and quality of life. Assessments were conducted at baseline and at 4, 8, and 12 weeks. Between-group differences were evaluated using multilevel modeling.Results: Forty-two patients were randomized to EASE (n = 22) or UC (n = 20), with 76% retention at 12 weeks. Predefined feasibility outcomes were met: 86% (19/22) of EASE participants completed ≥ 50% of EASE-psy sessions (goal ≥ 64%); 100% received Edmonton Symptom Assessment System (ESAS, modified for AL) screenings, 64% (14/22) of whom completed ≥ 50% of planned screenings (goal ≥50%); and 100% with scores ≥ 4/10 on any physical ESAS-AL item had ≥ 1 meeting with the EASE-phys team (goal 100%). Significant treatment-group differences favoring EASE were observed in traumatic stress symptoms at 4 and 12 weeks, and pain intensity and interference at 12 weeks (all p < .05).Conclusions: EASE is feasible in patients newly diagnosed with AL and shows promise of effectiveness. These results warrant a larger RCT to provide evidence for its more routine use as a standard of care. [ABSTRACT FROM AUTHOR]

Purpose: The Breast Cancer Treatment Outcome Scale (BCTOS) is a questionnaire to evaluate the aesthetic and functional outcome after breast conserving surgery (BCS). The original BCTOS with its 22 items on three subscales was refined to a shorter, improved, and easier to administer patient-reported outcome measure, the BCTOS-12. The BCTOS-12 consists of 12 items on two distinct subscales, the Functional Status and the Aesthetic Status. The aim of this study was to validate the BCTOS-12 in a prospective cohort.Methods: For this study, 239 breast cancer patients were included preoperatively, and 204 patients completed the BCTOS-12 and EORTC QLQ C30 BR23 shortly after their BCS, corresponding to a follow-up rate of 85%. The item-factor structure was examined by confirmatory factor analysis. The reliability was calculated by McDonald's Omega for estimating internal consistency. The convergent validity was assessed by Spearman's rank correlation coefficients between the related scales of the questionnaires.Results: The BCTOS-12 showed a robust item-factor structure and a good internal consistency with McDonald's Omega of 0.89 for the Aesthetic Status and 0.90 for the Functional Status. A high convergent and divergent validity was indicated by correlations between the subscales of the EORTC QLQ C30 BR23 and the BCTOS-12.Conclusion: Overall, the results demonstrate a successful psychometric validation of the BCTOS-12. The BCTOS-12 is a refined, improved, and now validated, instrument. It can be used in clinical studies and routine management for the evaluation of the aesthetic and functional outcome after BCS. [ABSTRACT FROM AUTHOR]

Purpose: Rural cancer survivors (RCS) have poorer health outcomes and face multiple challenges-older age, and limited transportation, education, income, and healthcare access. Yet, RCS are understudied. The Reach-out to ENhancE Wellness(RENEW) trial, a home-based, diet and exercise intervention among 641 breast, prostate, and colorectal cancer survivors addressed many of these challenges.Methods: We examined whether rural and urban participants differed in their response to the RENEW intervention (e.g., physical functioning, quality-of-life, intakes of fruits and vegetables (F&V) and saturated fat, body mass index(BMI), physical activity, and adverse events).Results: Rural versus urban survivors report significantly more favorable mean (SE) changes in physical functioning [- 0.66 (1.47) v - 1.71 (1.00)], physical health [+ 0.14 (0.71) v - 0.74 (0.50)], and fewer adverse events [1.58 (0.08) v 1.64 (0.06)]. Rural versus urban survivors reported smaller increases in F&Vs [+ 1.47 (0.23) v + 1.56(0.16); p = 0.018], and lower percentages achieved goal behavior for endurance exercise and intakes of F&Vs and saturated fat.Conclusions: The RENEW intervention reduced declines in physical health and functioning among RCS to a significantly greater extent than for urban cancer survivors. All survivors significantly improved intakes of F&V and saturated fat, and endurance exercise; however, lower percentages of rural versus urban survivors met goal suggesting that more intensive interventions may be needed for RCS. [ABSTRACT FROM AUTHOR]

Purpose: Early detection and improved treatment have increased lung cancer survival. Lung cancer survivors have more symptom distress and lower function compared with other cancer survivors; however, few interventions are available to improve health-related quality of life (HR-QOL). Lifestyle risk reduction interventions have improved HR-QOL in other cancer survivors. The purpose of this study was to explore lung cancer survivor perspectives on making behavioral changes in the context of a lifestyle risk reduction intervention.Methods: Twenty-two lung cancer survivors participated in interviews after completing the Healthy Directions (HD) intervention. Interviews were audiotaped, transcribed, and analyzed using inductive content analysis. Demographic and clinical characteristics were gathered through a survey and analyzed using descriptive statistics.Results: Five main themes were identified: (1) the diagnosis was a motivator for behavior change, (2) participants had to deal with disease consequences, (3) the coach provided guidance, (4) strategies for change were initiated, and (5) social support sustained behavioral changes. Other important subthemes were the coach helped interpret symptoms, which supported self-efficacy and goal setting, and survivors employed self-monitoring behaviors. Several participants found the recommended goals for physical activity were difficult and were discouraged if unable to attain the goal. Findings underscore the need for individualized prescriptions of physical activity, especially for sedentary survivors.Conclusions: Lung cancer survivors described the benefits of coaching to enhance their engagement in behavioral change. Additional research is needed to validate the benefit of the HD intervention to improve HR-QOL among this vulnerable and understudied group of cancer survivors. [ABSTRACT FROM AUTHOR]

Purpose: Intensive care unit survivors suffer from prolonged impairment, reduced quality of life, and higher mortality rates after discharge compared to the general population. Socioeconomic status may play a partial but important role in mortality and recovery. Therefore, the detection of factors that are responsible for poor long-term outcomes would be beneficial in designing targeted interventions for at-risk populations.Methods: For an endpoint analysis, 1834 intensive care unit patients with known French Deprivation Index (FDep) scores were included from the French and euRopean Outcome reGistry in Intensive Care Units (FROG-ICU) study, which was a prospective, observational, multicenter cohort study performed in 20 French intensive care units in 13 different hospitals. Socioeconomic status was defined by using the FDep score [represented as quintiles when referring to the general French population, as quintiles when referring to the FROG-ICU cohort, or as dichotomized data (which was defined as a FDep ≤ 0 for nondeprived patients)] and by using a detailed social questionnaire that was completed 3 months after discharge. The primary outcome included an all-cause, 1-year mortality after ICU discharge when regarding socioeconomic status. The secondary outcomes included both ICU and hospital lengths of stay, both short- and medium-term mortality, and the quality of life, as assessed during the 1-year follow-up by using the Medical Outcome Survey Short Form-36 (SF-36). The Revised Impact of Event Scale (IES-R) was used to evaluate the symptoms of post-traumatic stress disorder, and the Hospital Anxiety and Depression Scale (HADS) was used to screen for anxiety and depression.Results: Of the 1447 patients who were discharged alive from the ICU, 19.2% died over the following year. No association was found between 1-year mortality and socioeconomic status, regardless of whether this association was analyzed in quintiles (p = 0.911 in the quintiles of the general French population; p = 0.589 in the quintiles of the FROG-ICU cohort itself) or as dichotomized data [nondeprived (n = 177; 1-year mortality of 18.2%) versus deprived (n = 97; 1-year mortality of 20.5%; p = 0.304)]. Moreover, no differences were found between the nondeprived and the deprived patients in the ICU and hospital lengths of stay, ICU mortalities, in-hospital mortalities, or 28-day mortalities. The SF-36 was below the score for the normal French population throughout the follow-up period. Socially deprived patients showed significantly lower median scores in the physical function subscale [55, interquartile range (IQR) (28.8-80) vs. 65, IQR (35-90); p = 0.014], the physical role subscale [25, IQR (0-75) vs. 33.3, IQR (0-100); p = 0.022], and the overall physical component scale [47.5, IQR (30-68.8) vs. 54.4, IQR (35-78.8); p = 0.010]. Up to 31.6% of survivors presented symptoms that indicated post-traumatic stress disorder, and up to 31.5% of survivors reported clinically meaningful symptoms of anxiety or depression.Conclusions: A lower socioeconomic status was associated with lower self-reported physical component scores in the nondeprived patients. Psychiatric symptoms are frequently reported after an ICU stay, and subsequent interventions should target those fields.Trial Registration: ClinicalTrials.gov NCT01367093; registered on June 6, 2011. [ABSTRACT FROM AUTHOR]

Approximately one-third of early childhood pupils in Ghana are struggling with meeting basic behavioral and developmental milestones, but little is known about mechanisms or factors that contribute to poor early childhood development. With a lack of developmental research to guide intervention or education program and policy planning, this study aimed to address these research gaps by examining a developmental mechanism for early childhood development. We tested a mediational mechanism model that examined the influence of parental wellbeing on parenting and children's development. Two hundred and sixty-two Ghanaian parents whose children attended early childhood classes (nursery to 3rd grade) were recruited. Data were gathered through parent interviews and Structural Equation Modeling was utilized to examine pathways of the model. Results support the mediational model that Ghanaian parents' depression was associated with less optimal parenting, and in turn greater child externalizing behavioral problems. This study adds new evidence of cross cultural consistency in early childhood development. [ABSTRACT FROM AUTHOR]

Background: Biomaterial research has made available a biologically derived fully resorbable poly-4-hydroxybutyrate (P4HB) mesh for use in ventral and incisional hernia repair (VIHR). This study evaluates outcomes of patients undergoing VIHR with P4HB mesh.Methods: An IRB-approved prospective pilot study was conducted to assess clinical and quality of life (QOL) outcomes for patients undergoing VIHR with P4HB mesh. Perioperative characteristics were defined. Clinical outcomes, employment status, QOL using 12-item short form survey (SF-12), and pain assessments were followed for 24 months postoperatively.Results: 31 patients underwent VIHR with bioresorbable mesh via a Rives-Stoppa approach with retrorectus mesh placement. The median patient age was 52 years, median body mass index was 33 kg/m2, and just over half of the patients were female. Surgical site occurrences occurred in 19% of patients, most of which were seroma. Hernia recurrence rate was 0% (median follow-up = 414 days). Patients had significantly improved QOL at 24 months compared to baseline for SF-12 physical component summary and role emotional (p < 0.05).Conclusions: Ventral hernia repair with P4HB bioresorbable mesh results in favorable outcomes. Early hernia recurrence was not identified among the patient cohort. Quality of life improvements were noted at 24 months versus baseline for this cohort of patients with bioresorbable mesh. Use of P4HB mesh for ventral hernia repair was found to be feasible in this patient population. (ClinicalTrials.gov Identifier: NCT01863030). [ABSTRACT FROM AUTHOR]

Purpose: The objective of this study was to analyze the clinical factors associated with changes in HRQoL in outpatients with schizophrenia using both generic and condition-specific HRQoL scales.Methods: Adult outpatients with schizophrenia at least 18 years of age who did not have an acute psychotic exacerbation in the 3 months prior to baseline were recruited. PANSS dimensions were calculated based on Lindenmayer et al.'s five factors. HRQoL data were assessed by patients using the Schizophrenia Quality of Life Scale (SQLS), the Short Form-36 (SF-36), and the EuroQol-5 Dimension (EQ-5D) questionnaires.Results: Out of the 1345 patients included at baseline, 1196 (89%) were evaluated at 12 months. Regression models showed that the factor most consistently associated with HRQoL at endpoint was change in the PANSS negative symptoms score. A decrease in the PANSS negative symptoms score from baseline to 1 year was associated with a decrease in HRQoL during the same period. There were also significant associations of the change in PANSS excitatory factor with all the HRQoL scales except the SF-36 PCS. Female gender was associated with a decrease in all HRQoL ratings. There was also a relationship between years since onset and HRQoL. The longer the time since illness onset, the larger the decrease in HRQoL.Conclusions: This study has found that, in outpatients with schizophrenia, changes in negative and excitement symptoms may have a greater an association with HRQoL than changes in positive, cognitive and depressive symptoms. [ABSTRACT FROM AUTHOR]

Background: Spending on new healthcare technologies increases net population health when the benefits of a new technology are greater than their opportunity costs-the benefits of the best alternative use of the additional resources required to fund a new technology.Objective: The objective of this study was to estimate the expected incremental cost per quality-adjusted life-year (QALY) gained of increased government health expenditure as an empirical estimate of the average opportunity costs of decisions to fund new health technologies. The estimated incremental cost-effectiveness ratio (ICER) is proposed as a reference ICER to inform value-based decision making in Australia.Methods: Empirical top-down approaches were used to estimate the QALY effects of government health expenditure with respect to reduced mortality and morbidity. Instrumental variable two-stage least-squares regression was used to estimate the elasticity of mortality-related QALY losses to a marginal change in government health expenditure. Regression analysis of longitudinal survey data representative of the general population was used to isolate the effects of increased government health expenditure on morbidity-related, QALY gains. Clinical judgement informed the duration of health-related quality-of-life improvement from the annual increase in government health expenditure.Results: The base-case reference ICER was estimated at AUD28,033 per QALY gained. Parametric uncertainty associated with the estimation of mortality- and morbidity-related QALYs generated a 95% confidence interval AUD20,758-37,667.Conclusion: Recent public summary documents suggest new technologies with ICERs above AUD40,000 per QALY gained are recommended for public funding. The empirical reference ICER reported in this article suggests more QALYs could be gained if resources were allocated to other forms of health spending. [ABSTRACT FROM AUTHOR]

Background: The EORTC QLU-C10D is a new multi-attribute utility instrument derived from the widely used cancer-specific quality-of-life (QOL) questionnaire, EORTC QLQ-C30. The QLU-C10D contains ten dimensions (Physical, Role, Social and Emotional Functioning; Pain, Fatigue, Sleep, Appetite, Nausea, Bowel Problems), each with four levels. To be used in cost-utility analysis, country-specific valuation sets are required.Objective: The aim of this study was to provide Australian utility weights for the QLU-C10D.Methods: An Australian online panel was quota-sampled to ensure population representativeness by sex and age (≥ 18 years). Participants completed a discrete choice experiment (DCE) consisting of 16 choice-pairs. Each pair comprised two QLU-C10D health states plus life expectancy. Data were analysed using conditional logistic regression, parameterised to fit the quality-adjusted life-year framework. Utility weights were calculated as the ratio of each QOL dimension-level coefficient to the coefficient on life expectancy.Results: A total of 1979 panel members opted in, 1904 (96%) completed at least one choice-pair, and 1846 (93%) completed all 16 choice-pairs. Dimension weights were generally monotonic: poorer levels within each dimension were generally associated with greater utility decrements. The dimensions that impacted most on choice were, in order, Physical Functioning, Pain, Role Functioning and Emotional Functioning. Oncology-relevant dimensions with moderate impact were Nausea and Bowel Problems. Fatigue, Trouble Sleeping and Appetite had relatively small impact. The value of the worst health state was -0.096, somewhat worse than death.Conclusions: This study provides the first country-specific value set for the QLU-C10D, which can facilitate cost-utility analyses when applied to data collected with the EORTC QLQ-C30, prospectively and retrospectively. [ABSTRACT FROM AUTHOR]

Purpose: Geriatric assessment and management (GAM) can identify current health issues and recommend interventions to optimize well-being of older adults, but no randomized trial has yet been completed in oncology. Therefore, a randomized phase 2 trial was conducted.Methods: A two-group parallel single-blinded randomized phase II trial ( ClinicalTrials.gov Identifier: NCT02222259) enrolled patients aged ≥70 years, diagnosed with stage 2-4 gastrointestinal, genitourinary, or breast cancer within 6 weeks of commencing chemotherapy at Princess Margaret Cancer Centre. The coprimary feasibility outcomes were the proportion of eligible patients enrolled and retained. The coprimary clinical outcomes were quality of life (QOL) (EORTC QLQ C30) and modification of cancer treatment. Descriptive and regression analyses using intent-to-treat analysis were conducted.Results: Sixty-one persons (64%) agreed to participate (31 allocated to intervention arm and 30 to control group). In the control group, more participants died and refused follow-up. The benefit of intervention over control on QOL at 3 months was greater for those who survived 6 months (difference 9.28; 95% CI -10.35 to 28.91) versus those who survived only 3 months (difference 6.55; 95% CI -9.63 to 22.73).Conclusions: This trial showed that it was feasible to recruit and retain older adults for a GAM study. Those who survived at least 6 months seemed to receive a greater QOL benefit than those who died or withdrew. [ABSTRACT FROM AUTHOR]

Introduction: Non-healing of anastomotic leakage can be observed in up to 50% after total mesorectal excision for rectal cancer. This study investigates the efficacy of early transanal closure of anastomotic leakage after pre-treatment with the Endosponge® therapy.Methods: In this prospective, multicentre, feasibility study, transanal suturing of the anastomotic defect was performed after vacuum-assisted cleaning of the presacral cavity. Primary outcome was the proportion of patients with a healed anastomosis at 6 months after transanal closure. Secondary, healing at last follow-up, continuity, direct medical costs, functionality and quality of life were analysed.Results: Between July 2013 and July 2015, 30 rectal cancer patients with a leaking low colorectal anastomosis were included, of whom 22 underwent neoadjuvant radiotherapy. Median follow-up was 14 (7-29) months. At 6 months, the anastomosis had healed in 16 (53%) patients. At last follow-up, anastomotic integrity was found in 21 (70%) and continuity was restored in 20 (67%) patients. Non-healing at 12 months was observed in 10/29 (34%) patients overall, and in 3/14 (21%) when therapy started within three weeks following the index operation. Major LARS was reported in 12/15 (80%) patients. The direct medical costs were €8933 (95% CI 7268-10,707) per patient.Conclusion: Vacuum-assisted early transanal closure of a leaking anastomosis after total mesorectal excision with 73% preoperative radiotherapy showed that acceptable anastomotic healing rates and stoma reversal rates can be achieved. Early diagnosis and start of treatment seems crucial. [ABSTRACT FROM AUTHOR]

Purpose: Gynecologic Cancer Intergroup Symptom Benefit Study (GCIG-SBS) Stage 2 aimed to review, revise, and validate a patient-reported outcome measure (PROM), the Measure of Ovarian Symptoms and Treatment concerns (MOST), developed in GCIG-SBS Stage 1 (MOSTv1, 35 items), and document recurrent ovarian cancer (ROC) symptom burden and benefit.Methods: GCIG-SBS Stage 2 recruited patients with platinum-resistant/refractory ROC (PRR-ROC) or potentially platinum-sensitive ROC with ≥ 3 lines of prior chemotherapy (PPS-ROC ≥ 3). Patients completed MOSTv1, QLQ-C30, QLQ-OV28, and FACT-O/FOSI at baseline and before cycle 3 of chemotherapy (pre-C3), and global assessments of change (MOST-Change) pre-C3. Clinicians rated patients' cancer-related symptoms, performance status, and adverse events. Convergent and divergent validity (Spearman's correlations), discriminative validity (effect sizes between groups classified by clinician-rated characteristics), and responsiveness (paired t tests in patients expected to experience clinically meaningful change) were assessed.Results: Of 948 recruits, 903 completed PROMs at baseline and 685 pre-C3. Baseline symptom burden was substantial for PRR-ROC and PPS-ROC ≥ 3. MOSTv2 has 24 items and five multi-item scales: abdominal symptoms (MOST-Abdo), disease or treatment-related symptoms (MOST-DorT), chemotherapy-related symptoms (MOST-Chemo), psychological symptoms (MOST-Psych), and MOST-Well-being. Correlations confirmed concurrent and divergent validity. Discriminative validity was confirmed by effect sizes that conformed with a priori hypotheses. MOST-Abdo was responsive to improvements in abdominal symptoms and MOST-Chemo detected the adverse effects of chemotherapy.Conclusions: The MOSTv2 validly quantifies patient-reported symptom burden, adverse effects, and symptom benefit in ROC, and as such is fit-for-purpose for clinical trials of palliative chemotherapy in ROC. Further research is required to assess test-retest reliability. [ABSTRACT FROM AUTHOR]

Purpose: Lower quality of life, especially in the physical domain (Physical-QOL), is common in patients after hematopoietic stem cell transplantation (HSCT). However, few studies explore changes in the Physical-QOL, i.e., physical symptoms, in everyday life of patients following HSCT. The present study addresses this gap by examining patient daily physical symptoms and their predictors in terms of demographic and clinical characteristics.Methods: Physical symptoms were reported by 188 patients (56.9% men; aged 47.6 ± 13.4 years) for 28 consecutive days after post-HSCT hospital discharge. Multilevel modeling was used to investigate fixed and random effects for physical symptom changes over time.Results: The results indicated that the initial level of physical symptoms (immediately after hospital discharge) systematically decreased over 28 days. Treatment toxicity (WHO scale; β = 0.09, p < .01) and baseline depressive symptoms (CES-D scale; β = 0.06, p < .01) were associated with the initial level of physical symptoms. Patients with more depressive symptoms before HSCT and with more adverse treatment effects presented with more physical symptoms immediately after hospital discharge. The type of transplant, diagnosis, and conditioning regimen differentiated the course of physical symptoms. Patients with leukemias and other myeloid neoplasms (β = 0.05, p < .01), after allogeneic HSCT (β = -0.06, p < .01), and with non-myeloablative conditioning (β = -0.09, p < .01) showed a significant lower decrease in symptoms over time. Patients with multiple myeloma presented with the most rapid improvement (β = -.03, p < .05).Conclusions: The findings suggest a heterogeneous and rather positive response to HSCT. Treatment-related conditions occurred to be a significant predictor of the intensity of change in physical functioning after HSCT. [ABSTRACT FROM AUTHOR]

Purpose: To test whether the systematic monitoring of health-related quality of life (HRQOL) in clinical practice in Spanish pediatric patients with T1DM helps improve their daily life in a multicenter longitudinal study.Methods: One hundred thirty-six patients participated, recruited from five centers in Barcelona, Spain (72 girls, mean age 13.4 years). Complete data were collected for 119 patients (85%). Pediatricians were randomly assigned to the HRQOL intervention (n = 70), or control group (n = 49). The intervention group discussed the results of HRQOL face to face with the physician, quarterly over a year. The control group received care as usual. HRQOL was assessed using KIDSCREEN-27 collected online. Standardized mean differences (effect size, ES) and generalized estimating equation (GEE) were computed to compare group differences between baseline and follow-up, taking into account sociodemographic and clinical variables.Results: Statistically significant higher scores were seen in the intervention group at follow-up for the dimensions of Psychological well-being (ES = 0.56), School environment (ES = 0.56), and the KIDSCREEN-10 index (ES = 0.63). No differences were found in the control group. GEE analysis showed an improvement in HRQOL at follow-up with statistically significant association of the intervention on Psychological well-being (B = 4.32; p 0.03 for the interaction of group by follow-up) and School environment (B = 4.64; p 0.02 for the same interaction term).Conclusions: Routine assessment and face-to-face patient-physician discussion of HRQOL results improved HRQOL scores after a year of follow-up, especially in Psychological well-being and school environment. The results support the routinary use of HRQOL assessment in clinical practice. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to assess the efficacy of a staff-training intervention to improve service users' engagement in activities and quality of care, by means of a cluster randomised controlled trial.Method: All residential units with at least 12-h a day staff support (n = 23) were invited to participate. Quality of care was assessed with the Quality Indicator for Rehabilitative Care (QuIRC) filled online by the unit's manager. Half the units (n = 12) were randomly assigned to continue providing treatment as usual, and half (n = 11) received a staff-training intervention that focused on skills for engaging service users in activities, with trainers working alongside staff to embed this learning in the service. The primary outcome was service users' level of activity (measured with the Time Use Diary), reassessed at 4 and 8 months. Secondary outcomes were the quality of care provided (QuIRC), and service users' quality of life (Manchester Short Assessment of Quality of Life) reassessed at 8 months. Generalized linear mixed effect models were used to assess the difference in outcomes between units in the two trial arms. The trial was registered with Current Controlled Trials (Ref NCT02366117).Results: Knowledge acquired by the staff during the initial workshops increased significantly (p ≤ 0.01). However, the intervention and comparison units did not differ significantly in primary and secondary outcomes at either follow-up.Conclusions: The intervention increased the level of knowledge of staff without leading to an improvement in service users' engagement in activities, quality of life, or quality of care in the units. [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: The purpose of this study was to assess the feasibility, acceptability, and impact of a ballroom dance intervention on improving quality of life (QOL) and relationship outcomes in cancer survivors and their partners.Methods: We conducted a pilot randomized controlled trial with two arms (Restoring Health in You (and Your Partner) through Movement, RHYTHM): (1) immediate dance intervention and (2) delayed intervention (wait-list control). The intervention consisted of 10 private weekly dance lessons and 2 practice parties over 12 weeks. Main outcomes were physical activity (Godin Leisure-Time Exercise Questionnaire), functional capacity (6 Minute Walk Test), QOL (SF-36), Couples' trust (Dyadic Trust Scale), and other dyadic outcomes. Exit interviews were completed by all participating couples.Results: Thirty-one women survivors (68% breast cancer) and their partners participated. Survivors were 57.9 years old on average and 22.6% African American. Partners had similar characteristics. RHYTHM had significant positive effects on physical activity (p = 0.05), on the mental component of QOL (p = 0.04), on vitality (p = 0.03), and on the dyadic trust scale (p = 0.04). Couples expressed satisfaction with the intervention including appreciating the opportunity to spend time and exercise together. Survivors saw this light-intensity physical activity as easing them into becoming more physically active.Conclusions: Light intensity ballroom dancing has the potential to improve cancer survivors' QOL. Larger trials are needed to build strong support for this ubiquitous and acceptable activity.Implications For Cancer Survivors: Ballroom dance may be an important tool for cancer survivors to return to a physically active life and improve QOL and other aspects of their intimate life. [ABSTRACT FROM AUTHOR]

Introduction: Mapping algorithms are increasingly being used to predict health-utility values based on responses or scores from non-preference-based measures, thereby informing economic evaluations.Objectives: We explored whether predictions in the EuroQol 5-dimension 3-level instrument (EQ-5D-3L) health-utility gains from mapping algorithms might differ if estimated using differenced versus raw scores, using the Roland-Morris Disability Questionnaire (RMQ), a widely used health status measure for low back pain, as an example.Methods: We estimated algorithms mapping within-person changes in RMQ scores to changes in EQ-5D-3L health utilities using data from two clinical trials with repeated observations. We also used logistic regression models to estimate response mapping algorithms from these data to predict within-person changes in responses to each EQ-5D-3L dimension from changes in RMQ scores. Predicted health-utility gains from these mappings were compared with predictions based on raw RMQ data.Results: Using differenced scores reduced the predicted health-utility gain from a unit decrease in RMQ score from 0.037 (standard error [SE] 0.001) to 0.020 (SE 0.002). Analysis of response mapping data suggests that the use of differenced data reduces the predicted impact of reducing RMQ scores across EQ-5D-3L dimensions and that patients can experience health-utility gains on the EQ-5D-3L 'usual activity' dimension independent from improvements captured by the RMQ.Conclusion: Mappings based on raw RMQ data overestimate the EQ-5D-3L health utility gains from interventions that reduce RMQ scores. Where possible, mapping algorithms should reflect within-person changes in health outcome and be estimated from datasets containing repeated observations if they are to be used to estimate incremental health-utility gains. [ABSTRACT FROM AUTHOR]

Purpose: To expand content of the physical function domain of the Work Disability Functional Assessment Battery (WD-FAB), developed for the US Social Security Administration's (SSA) disability determination process.Methods: Newly developed questions were administered to 3532 recent SSA applicants for work disability benefits and 2025 US adults. Factor analyses and item response theory (IRT) methods were used to calibrate and link the new items to the existing WD-FAB, and computer-adaptive test simulations were conducted.Results: Factor and IRT analyses supported integration of 44 new items into three existing WD-FAB scales and the addition of a new 11-item scale (Community Mobility). The final physical function domain consisting of: Basic Mobility (56 items), Upper Body Function (34 items), Fine Motor Function (45 items), and Community Mobility (11 items) demonstrated acceptable psychometric properties.Conclusions: The WD-FAB offers an important tool for enhancement of work disability determination. The FAB could provide relevant information about work-related functioning for initial assessment of claimants; identifying denied applicants who may benefit from interventions to improve work and health outcomes; enhancing periodic review of work disability beneficiaries; and assessing outcomes for policies, programs and services targeting people with work disability. [ABSTRACT FROM AUTHOR]

Purpose: Preference-based generic measures are gaining increased use in mobility research to assess health-related quality of life and wellbeing. Hence, we examined the responsiveness of these two measures among individuals at risk of mobility impairment among adults aged ≥70 years.Methods: We conducted a 12-month prospective cohort study of community-dwelling older adults (n = 288 to n = 341 depending on analysis) who were seen at the Vancouver Falls Prevention Clinic who had a history of at least one fall in the previous 12 months. We compared the responsiveness of the EuroQol-5 Domain-3 Level (EQ-5D-3L) and the index of capability for older adults (ICECAP-O) by examining changes in these measures over time (i.e., over 6 and 12 months) and by examining whether their changes varied as a function of having experienced 2 or more falls over 6 and 12 months.Results: Only the ICECAP-O showed a significant change over time from baseline through 12 months; however, neither measure showed change that exceeded the standard error of the mean. Both measures were responsive to falls that occurred during the first 6 months of the study (p < .05). These effects appeared to be amplified among individuals identified as having mild cognitive impairment (MCI) at baseline (p < .01). Additionally, the EQ-5D-3L was responsive among fallers who did not have MCI as well as individuals with MCI who did not fall (p < .05).Conclusion: This study provides initial evidence suggesting that the EQ-5D-3L is generally more responsive, particularly during the first 6 months of falls tracking among older adults at risk of future mobility impairment. [ABSTRACT FROM AUTHOR]

Dental problems are among the most frequently reported health issues of drug users. This study describes, among the largest population of methamphetamine (MA) users to date (N = 459, including both HIV-negative and HIV-positive participants) oral hygiene practice, dental care access, and dental quality of life. A matched control group from the Third National Health and Nutrition Examination Survey was utilized. Findings conclusively establish that MA users have severe oral health deficits compared to the general population: they are 3.5 times more likely to experience painful toothaches, 6.6 times to experience difficulty eating, and 8.6 times to be self-conscious due to dental appearance. HIV-positive users were more likely to have regular dental visits than HIV-negative users. Severity of use (both high-frequency use as well as injection as the method) was associated with poorer oral health care. Despite the magnitude of the need, few MA users receive the needed care. [ABSTRACT FROM AUTHOR]

Background: Prostate cancer can negatively impact quality of life of the patient and his spouse caregiver, but interventions rarely target the health of both partners simultaneously. We tested the feasibility and preliminary efficacy of a partnered strength training program on the physical and mental health of prostate cancer survivors (PCS) and spouse caregivers.Methods: Sixty-four couples were randomly assigned to 6 months of partnered strength training (Exercising Together, N = 32) or usual care (UC, N = 32). Objective measures included body composition (lean, fat and trunk fat mass (kg), and % body fat) by DXA, upper and lower body muscle strength by 1-repetition maximum, and physical function by the physical performance battery (PPB). Self-reported measures included the physical and mental health summary scales and physical function and fatigue subscales of the SF-36 and physical activity with the CHAMPS questionnaire.Results: Couple retention rates were 100 % for Exercising Together and 84 % for UC. Median attendance of couples to Exercising Together sessions was 75 %. Men in Exercising Together became stronger in the upper body (p < 0.01) and more physically active (p < 0.01) than UC. Women in Exercising Together increased muscle mass (p = 0.05) and improved upper (p < 0.01) and lower body (p < 0.01) strength and PPB scores (p = 0.01) more than UC.Conclusions: Exercising Together is a novel couples-based approach to exercise that was feasible and improved several health outcomes for both PCS and their spouses.Implications For Cancer Survivors: A couples-based approach should be considered in cancer survivorship programs so that outcomes can mutually benefit both partners.Trial Registration: ClinicalTrials.gov NCT00954044. [ABSTRACT FROM AUTHOR]

Purpose: Current patient-reported outcomes for female urinary incontinence (UI) are limited by their inability to be tailored. Our objective is to describe the development and field testing of seven item banks designed to measure domains identified as important UI in females (UIf). We also describe the calibration and validation properties of the UIf-item banks, which allow for more efficient computerized adaptive testing (CAT) in the future.Methods: The UIf-measures included 168 items covering seven domains: Stress UI (SUI), overactive bladder (OAB), urinary frequency, physical, social and emotional health impact and adaptation. Items underwent rigorous qualitative development and psychometric testing across two sites. Items were calibrated using item response theory and evaluated for internal consistency, construct validity and responsiveness.Results: A total of 750 women (249 SUI, 249 OAB and 252 mixed UI) participated. Mean age was 55 ± 14 years, and 23 % were Hispanic and 80 % white. In addition to face and content validity, the measures demonstrated good internal consistency (coefficient alpha 0.92-0.98) and unidimensionality. There was evidence for construct validity with moderate-to-strong correlations with the UDI (r's ≥ 0.6) and IIQ (r's = ≥0.6) scales. The measures were responsive to change for SUI treatment (paired t test p < .001, ES range 1.3-2.9; SRM range 1.3-2.5) and OAB treatment (paired t test p < .05 for all domains except social health impact and adaptation, ES range 0.3-1.5, SRM range 0.4-1.0). The measures were responsive based on concurrent changes with the UDI and IIQ (p < 0.05). CAT versions were developed and pilot-tested.Conclusions: The UIf-item banks demonstrate good psychometric characteristics and are a sufficiently valid set of customizable tools for measuring UI symptoms and life impact. [ABSTRACT FROM AUTHOR]

Purpose: Osteoarthritis (OA) has been shown to be associated with decreased physical function, which may impact upon a person's self-rated health (SRH). Only a few studies have examined the association between OA and SRH in the general population, but to date none have used a clinical definition of OA. The objectives are: (1) To examine the cross-sectional association between clinical OA and fair-to-poor SRH in the general population; (2) To examine whether this association differs between countries; (3) To examine whether physical function is a mediator in the association between clinical OA and SRH.Methods: Baseline data of the European Project on OSteoArthritis (EPOSA) were used, which includes pre-harmonized data from six European cohort studies (n = 2709). Clinical OA was defined according to the American College of Rheumatology criteria. SRH was assessed using one question: How is your health in general? Physical function was assessed using the Western Ontario and McMaster Universities OA Index and Australian/Canadian OA Hand Index.Results: The prevalence of fair-to-poor SRH ranged from 19.8 % in the United Kingdom to 63.5 % in Italy. Although country differences in the strength of the associations were observed, clinical OA of the hip, knee and hand were significantly associated with fair-to-poor SRH in five out of six European countries. In most countries and at most sites, the association between clinical OA and fair-to-poor SRH was partly or fully mediated by physical function.Conclusions: Clinical OA at different sites was related to fair-to-poor SRH in the general population. Most associations were (partly) mediated by physical functioning, indicating that deteriorating physical function in patients with OA should be a point of attention in patient care. [ABSTRACT FROM AUTHOR]

Purpose: Cancer-related cognitive impairment (CRCI) is a common, fatigue-related symptom that disrupts cancer survivors' quality of life. Few interventions for CRCI exist. As part of a randomized pilot study targeting cancer-related fatigue, the effects of mindfulness-based stress reduction (MBSR) on survivors' cognitive outcomes were investigated.Methods: Breast and colorectal cancer survivors (n = 71) with moderate-to-severe fatigue were randomized to MBSR (n = 35) or a fatigue education and support (ES; n = 36) condition. The Attentional Function Index (AFI) and the Stroop test were used to assess survivors' cognitive function at baseline (T1), after the 8-week intervention period (T2), and 6 months later (T3) using intent-to-treat analysis. Mediation analyses were performed to explore mechanisms of intervention effects on cognitive functioning.Results: MBSR participants reported significantly greater improvement on the AFI total score compared to ES participants at T2 (d = 0.83, p = 0.001) and T3 (d = 0.55, p = 0.021). MBSR also significantly outperformed ES on most AFI subscales, although both groups improved over time. MBSR produced greater Stroop accuracy rates relative to ES at T2 (r = 0.340, p = 0.005) and T3 (r = 0.280, p = 0.030), with improved accuracy over time only for the MBSR group. There were no significant differences in Stroop reaction time between groups. Improvements in mindfulness mediated the effect of group (e.g., MBSR vs. ES) on AFI total score at T2 and T3.Conclusions: Additional randomized trials with more comprehensive cognitive measures are warranted to definitively assess the efficacy of MBSR for CRCI.Implications For Cancer Survivors: This pilot study has important implications for all cancer survivors as it is the first published trial to show that MBSR offers robust and durable improvements in CRCI. [ABSTRACT FROM AUTHOR]

Purpose: Our aim was to study how patients and their clinicians evaluated the usability of PatientViewpoint, a webtool designed to allow patient-reported outcome (PRO) measures to be used in clinical practice.Methods: As part of a two-round quality improvement study, breast and prostate cancer patients and their medical and radiation oncology clinicians completed semi-structured interviews about their use of PatientViewpoint. The patient interview addressed different phases of the PRO completion workflow: reminders, completing the survey, and viewing the results. The clinician interviews asked about use of PatientViewpoint, integration with the clinical workflow, barriers to use, and helpful and desired features. Responses were recorded, categorized, and reviewed. After both rounds of interviews, modifications were made to PatientViewpoint.Results: Across the two rounds, 42 unique patients (n = 19 in round 1, n = 23 in round 2) and 12 clinicians (all in both rounds) completed interviews. For patients, median age was 65, 81 % were white, 69 % were college graduates, 80 % had performance status of 0, 69 % had loco-regional disease, and 81 % were regular computer users. In the quality improvement interviews, patients identified numerous strengths of the system, including its ability to flag issues for discussion with their provider. Comments included confusion about how scores were presented and that the value of the system was diminished if the doctor did not look at the results. Requests included tailoring questions to be applicable to the individual and providing more explanation about the score meaning, including having higher scores consistently indicating either better or worse status. Clinicians also provided primarily positive feedback about the system, finding it helpful in some cases, and confirmatory in others. Their primary concern was with impact on their workflow.Conclusions: Systematically collected feedback from patients and clinicians was useful to identify ways to improve a system to incorporate PRO measures into oncology practice. The findings and evaluation methods should be useful to others in efforts to integrate PRO assessments into ambulatory care.Implications For Cancer Survivors: Systems to routinely collect patient-reported information can be incorporated into oncology practices and provide useful information that promote patient and clinician partnership to improve the quality of care. [ABSTRACT FROM AUTHOR]

Purpose: Computer-based, patient-reported symptom survey tools have been described for patients undergoing chemotherapy. We hypothesized that patients undergoing radiotherapy might also benefit, so we developed a computer application to acquire symptom ratings from patients and generate summaries for use at point of care office visits and conducted a randomized, controlled pilot trial to test its feasibility.Methods: Subjects were randomized prior to beginning radiotherapy. Both control and intervention group subjects completed the computerized symptom assessment, but only for the intervention group were printed symptom summaries made available before each weekly office visit. Metrics compared included the Global Distress Index (GDI), concordance of patient-reported symptoms and symptoms discussed by the physician and numbers of new and/or adjusted symptom management medications prescribed.Results: One hundred twelve patients completed the study: 54 in the control and 58 in the intervention arms. There were no differences in GDI over time between the control and intervention groups. In the intervention group, more patient-reported symptoms were actually discussed in radiotherapy office visits: 46/202 vs. 19/230. A sensitivity analysis to account for within-subjects correlation yielded 23.2 vs. 10.3 % (p = 0.03). Medications were started or adjusted at 15.4 % (43/280) of control visits compared to 20.4 % (65/319) of intervention visits (p = 0.07).Conclusions: This computer application is easy to use and makes extensive patient-reported outcome data available at the point of care. Although no differences were seen in symptom trajectory, patients who had printed symptom summaries had improved communication during office visits and a trend towards a more active symptom management during radiotherapy. [ABSTRACT FROM AUTHOR]

Purpose: Research studies that measure health-related quality of life (HRQOL) in both children and adults and longitudinal studies that follow children into adulthood need measures that can be compared across these age groups. This study links the PROMIS pediatric and adult emotional distress measures using data from participants with diverse health conditions and disabilities.Methods: Analyses were conducted and compared in two separate samples to confirm the stability of results. One sample (n = 874) included individuals aged 14-20 years with special health care needs and who require health services. The other sample (n = 641) included individuals aged 14-25 years who have a physical or cognitive disability. Participants completed both PROMIS pediatric and adult measures. Item response theory-based scores were linked using the linear approximation to calibrated projection.Results: The estimated latent-variable correlation between pediatric and adult PROMIS measures ranged from 0.87 to 0.94. Regression coefficients β 0 (intercept) and β 1 (slope), and mean squared error are provided to transform scores from the pediatric to the adult measures, and vice versa.Conclusions: This study used a relatively new linking method, calibrated projection, to link PROMIS pediatric and adult measure scores, thus expanding the use of PROMIS measures to research that includes both populations. [ABSTRACT FROM AUTHOR]