App-based self-guided mindfulness training for adults with epilepsy: a six-week single-arm feasibility study.

Background: Fatigue associated with chemotherapy-induced anemia (CIA) is common in patients with breast cancer, and can have adverse effects on quality of life (QoL). Erythropoiesis-stimulating agents (ESAs) reduce the need for transfusions and may improve QoL in patients with symptomatic CIA. Information on hemoglobin (Hb) levels and effects of fatigue on QoL in patients with breast cancer and CIA in real-world clinical practice is limited. Methods: The Electronic Assessment of Quality of Life in Patients With Symptomatic CIA (eAQUA) study evaluated improvements in QoL for patients with CIA receiving ESAs who had an increase in Hb of ≥1 g/dL by week 9. This phase 4, international, longitudinal, prospective, observational study enrolled patients with solid tumors who received chemotherapy and had symptomatic anemia. Patients received ESA therapy for up to 13 weeks based on European indication. The primary outcome was the proportion of patients with increase in Hb ≥1 g/dL and improvement in fatigue-related QoL based on the Functional Assessment of Cancer Therapy-Fatigue (FACT-F; scale = 0 to 52 with lower scores indicating worse fatigue) subscale scores and fatigue Visual Analog Scale (VAS; scale = 0 to 100 with higher scores indicating worse fatigue) from baseline to week 9. FACT-F change scores were anchored to VAS change scores to determine the minimally important difference (MID) for improvements in QoL. Patients with a FACT-F change score that was ≥ the MID were considered to have an improvement in QoL. For Hb and QoL outcomes, week 9 data were those assessed closest to on-treatment day 57 (after initiation of ESA) and within on-treatment days 43 to 70 inclusive, to account for different ESA dosing schedules and the observational nature of the study. Secondary outcomes included rates of red blood cell (RBC) transfusions or iron supplementation during the study. Results: Of 1262 patients enrolled in eAQUA, 289 had breast cancer and were included in the full analysis set (FAS; had at least one ESA dose); of these, 152 patients were eligible to be included in the primary analysis set (PAS; had QoL and Hb data available at baseline and week 9). At baseline, mean (standard deviation [SD]) Hb was 9.4 (0.6) g/dL; mean (SD) FACT-F and VAS scores were 27.1 (10.5) and 52.7 (22.8), respectively, in the FAS. Mean (SD) change from baseline at week 9 was 1.3 (1.3) g/dL for Hb; 4.1 (10.8) score change for FACT-F; and 4.7 (25.9) score change for VAS in the FAS. A total of 54 (18.7%) patients in the FAS required an RBC transfusion and 79 (27.3%) received iron supplementation. At week 9, 77 of 152 patients in the PAS had achieved improvement in fatigue-related QoL (50.7%; 95% confidence interval [CI] = 42.7%, 58.6%); 93 patients had increased Hb ≥1 g/dL (61.2%; 95% CI = 53.4%, 68.9%); and 59 patients (38.8%; 95% CI = 31.1%, 46.6%) had achieved both improvement in fatigue-related QoL and increased Hb ≥1 g/dL. Conclusions: In this exploratory subgroup analysis, patients with breast cancer and symptomatic CIA treated with ESAs achieved clinically meaningful improvements in fatigue-related QoL and Hb levels. Citation Format: Mario Airoldi, Dominique Spaeth, Joan Van den Bosch, Charalambos Christofyllakis, Laura Belton, Chet Bohac, Jan-Henrik Terwey, Giuseppe Tonini. Hemoglobin levels and quality of life in patients with breast cancer and symptomatic chemotherapy-induced anemia enrolled in the eAQUA study [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P5-15-18.

e21070 Background: There is little data on quality of life (QoL) for patients (pts) with Merkel cell carcinoma (MCC). To better understand how new treatments might impact QoL in MCC, pts with stage IV chemotherapy-treated MCC from a single-arm, open-label, multicenter, international phase 2 trial (NCT02155647) of a novel immunotherapy were followed for QoL and clinical outcomes. Methods: Because there is no MCC-specific QoL instrument, the FACT-Melanoma (FACT-M), a validated QoL questionnaire including multiple subscales and summary scores (Trial Outcome Index [TOI], FACT-G total and FACT-M total) was used. Pts completed the FACT-M at baseline (BL), week 7, every 6 weeks until disease progression (PD) and at end of treatment (EOT). Linear mixed models (LMM) were fitted for change from BL for each scale including the time-varying covariate PD vs non-PD. Established minimal important differences (MID) were used to interpret meaningfulness of changes. Sensitivity analyses explored the effects of missing data. Results: 70 pts were analyzed. Overall, no meaningful changes from BL were observed for each scale during treatment. Moderate correlations between reduction in tumor size and improvements in FACT-M were observed at week 7 for Functional Well-being (-0.47), TOI (-0.36), FACT-M total (-0.36), and FACT-G total (-0.34), suggesting improvements in QoL with tumor shrinkage. LMM showed differences between PD vs non-PD groups in the range of MIDs for Functional Well-being (2.23, p = 0.018), Melanoma (3.19, p = 0.012), Surgery (1.95, p = 0.109), TOI (6.36, p = 0.012) and FACT-G total (3.89, p = 0.105). These models showed improvement for the non-PD group in Emotional Well-being (1.55, p = 0.004) and worsening for the PD group in Physical Well-being (-1.63, p = 0.041), Surgery (-2.09, p = 0.044) and TOI (-4.56, p = 0.036). As expected, all scales worsened in the range of MIDs at EOT, mostly due to PD. Sensitivity analyses were consistent, with modest increases in estimated differences. Conclusions: In pts with metastatic MCC, non-progression during avelumab treatment contributed to statistically and clinically meaningful improvements in health-related QoL. Clinical trial information: NCT02155647.

We included 10 studies involving 894 participants (range 24 to 412 participants (n = 2 studies involving n > 100, one contributing to meta-analysis), mean age range 27 to 54 years). We identified one ongoing study and three studies awaiting classification. One study was synthesised narratively, and another involved participants specifically with asthma-COPD overlap. Most programmes were outpatient-based, lasting from three to four weeks (inpatient) or eight to 12 weeks (outpatient). Education or self-management components included breathing retraining and relaxation, nutritional advice and psychological counselling. One programme was specifically tailored for people with severe asthma. Pulmonary rehabilitation compared to usual care may increase maximal oxygen uptake (VO₂ max) after programme completion, but the evidence is very uncertain for data derived using mL/kg/min (MD between groups of 3.63 mL/kg/min, 95% confidence interval (CI) 1.48 to 5.77; 3 studies; n = 129) and uncertain for data derived from % predicted VO₂ max (MD 14.88%, 95% CI 9.66 to 20.1%; 2 studies; n = 60). The evidence is very uncertain about the effects of pulmonary rehabilitation compared to usual care on incremental shuttle walk test distance (MD between groups 74.0 metres, 95% CI 26.4 to 121.4; 1 study; n = 30). Pulmonary rehabilitation may have little to no effect on VO₂max at longer-term follow up (9 to 12 months), but the evidence is very uncertain (MD -0.69 mL/kg/min, 95% CI -4.79 to 3.42; I² = 49%; 3 studies; n = 66). Pulmonary rehabilitation likely improves functional exercise capacity as measured by 6-minute walk distance, with MD between groups after programme completion of 79.8 metres (95% CI 66.5 to 93.1; 5 studies; n = 529; moderate certainty evidence). This magnitude of mean change exceeds the minimally clinically important difference (MCID) threshold for people with chronic respiratory disease. The evidence is very uncertain about the longer-term effects one year after pulmonary rehabilitation for this outcome (MD 52.29 metres, 95% CI 0.7 to 103.88; 2 studies; n = 42). Pulmonary rehabilitation may result in a small improvement in asthma control compared to usual care as measured by Asthma Control Questionnaire (ACQ), with an MD between groups of -0.46 (95% CI -0.76 to -0.17; 2 studies; n = 93; low certainty evidence); however, data derived from the Asthma Control Test were very uncertain (MD between groups 3.34, 95% CI -2.32 to 9.01; 2 studies; n = 442). The ACQ finding approximates the MCID of 0.5 points. Pulmonary rehabilitation results in little to no difference in asthma control as measured by ACQ at nine to 12 months follow-up (MD 0.09, 95% CI -0.35 to 0.53; 2 studies; n = 48; low certainty evidence). Pulmonary rehabilitation likely results in a large improvement in quality of life as assessed by the St George's Respiratory Questionnaire (SGRQ) total score (MD -18.51, 95% CI -20.77 to -16.25; 2 studies; n = 440; moderate certainty evidence), with this magnitude of change exceeding the MCID. However, pulmonary rehabilitation may have little to no effect on Asthma Quality of Life Questionnaire (AQLQ) total scores, with the evidence being very uncertain (MD 0.87, 95% CI -0.13 to 1.86; 2 studies; n = 442). Longer-term follow-up data suggested improvements in quality of life may occur as measured by SGRQ (MD -13.4, 95% CI -15.93 to -10.88; 2 studies; n = 430) but not AQLQ (MD 0.58, 95% CI -0.23 to 1.38; 2 studies; n = 435); however, the evidence is very uncertain. One study reported no difference between groups in the proportion of participants who experienced an asthma exacerbation during the intervention period. Data from one study suggest adverse events attributable to the intervention are rare. Overall risk of bias was most commonly impacted by performance bias attributed to a lack of participant blinding to knowledge of the intervention. This is inherently challenging to overcome in rehabilitation studies. AUTHORS' CONCLUSIONS: Moderate certainty evidence shows that pulmonary rehabilitation is probably associated with clinically meaningful improvements in functional exercise capacity and quality of life upon programme completion in adults with asthma. The certainty of evidence relating to maximal exercise capacity was very low to low. Pulmonary rehabilitation appears to confer minimal effect on asthma control, although the certainty of evidence is very low to low. Unclear reporting of study methods and small sample sizes limits our certainty in the overall body of evidence, whilst heterogenous study designs and interventions likely contribute to inconsistent findings across clinical outcomes and studies. There remains considerable scope for future research.

BackgroundGuidelines and experts describe 5% to 10% reductions in body weight as ‘clinically important’; however, it is not clear if 5% to 10% weight reductions correspond to clinically important improvements in health-related quality of life (HRQL). Our objective was to calculate the amount of weight loss required to attain established minimal clinically important differences (MCIDs) in HRQL, measured using three validated instruments.MethodsData from the Alberta Population-based Prospective Evaluation of Quality of Life Outcomes and Economic Impact of Bariatric Surgery (APPLES) study, a population-based, prospective Canadian cohort including 150 wait-listed, 200 medically managed and 150 surgically treated patients were examined. Two-year changes in weight and HRQL measures (Short-Form (SF)-12 physical (PCS; MCID = 5) and mental (MCS; MCID = 5) component summary score, EQ-5D Index (MCID = 0.03) and Visual Analog Scale (VAS; MCID = 10), Impact of Weight on Quality of Life (IWQOL)-Lite total score (MCID = 12)) were calculated. Separate multivariable linear regression models were constructed within medically and surgically treated patients to determine if weight changes achieved HRQL MCIDs. Pooled analysis in all 500 patients was performed to estimate the weight reductions required to achieve the pre-defined MCID for each HRQL instrument.ResultsMean age was 43.7 (SD 9.6) years, 88% were women, 92% were white, and mean initial body mass index was 47.9 (SD 8.1) kg/m2. In surgically treated patients (two-year weight loss = 16%), HRQL MCIDs were reached for all instruments except the SF-12 MCS. In medically managed patients (two-year weight loss = 3%), MCIDs were attained in the EQ-index but not the other instruments. In all patients, percent weight reductions to achieve MCIDs were: 23% (95% confidence interval (CI): 17.5, 32.5) for PCS, 25% (17.5, 40.2) for MCS, 9% (6.2, 15.0) for EQ-Index, 23% (17.3, 36.1) for EQ-VAS, and 17% (14.1, 20.4) for IWQOL-Lite total score.ConclusionsWeight reductions to achieve MCIDs for most HRQL instruments are markedly higher than the conventional threshold of 5% to 10%. Surgical, but not medical treatment, consistently led to clinically important improvements in HRQL over two years.Trial registrationClinicaltrials.gov NCT00850356.Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-014-0175-5) contains supplementary material, which is available to authorized users.

Pediatric Patient-Reported Quality of Life Before and after Radiotherapy: A Prospective Registry Study

Determining the Minimal Clinically Important Difference of the Functional Assessment of Cancer Therapy Hepatobiliary Questionnaire to Evaluate the Change in the Quality of Life of Patients With Pancreatic Cancer During Radiation Therapy

Our main objective was to compare the change in a validated quality of life measure to a global assessment measure. The secondary objectives were to estimate the minimum clinically important difference (MCID) and to describe the change in quality of life by surgical specialty. This prospective cohort study included 7902 adult patients undergoing elective surgery. Changes in the Veterans RAND 12-Item Health Survey (VR-12), composed of a physical component summary (PCS) and a mental component summary (MCS), were calculated using preoperative and postoperative questionnaires. The latter also contained a global assessment question for quality of life. We compared PCS and MCS to the global assessment using descriptive statistics and weighted kappa. MCID was calculated using an anchor-based approach. Analyses were pre-specified and registered (NCT02771964). By the change in VR-12 scores, an equal proportion of patients experienced improvement and deterioration in quality of life (28% for PCS, 25% for MCS). In contrast, by the global assessment measure, 61% reported improvement, while only 10% reported deterioration. Agreement with the global assessment was slight for both PCS (kappa = 0.20, 57% matched) and MCS (kappa = 0.10, 54% matched). The MCID for the overall VR-12 score was approximately 2.5 points. Patients undergoing orthopedic surgery showed the most improvement in quality of life measures, while patients undergoing gastrointestinal/hepatobiliary or urologic surgery showed the most deterioration. Subjective global quality of life report does not agree well with a validated quality of life instrument, perhaps due to patient over-optimism.

Improvements in Health-Related Quality of Life after Exagamglogene Autotemcel in Patients with Severe Sickle Cell Disease

Editorial: Writing for CORR ® (Revisited).

Quality of life one year after epilepsy surgery

Aims: The Life Participation for Parents (LPP®) is a Quality of Life assessment designed to measure family-centered practice outcomes. Previous studies of the LPP have established its internal consistency (Cronbach’s alpha = .85), test–retest reliability (r = .89), construct validity, and concurrent validity. This study examined the responsiveness of the LPP, hypothesizing change scores after 3 months of intervention would exceed that explained by standard error. Methods: Thirty-two parents of children with disabilities completed the LPP to identify family-centered issues. The LPP was completed a second time after 3 months of intervention. Wilcoxon Signed Rank test was used to compare the median differences between two administrations. Minimal clinically important differences (MCID) were calculated for the total and two LPP subscales (efficiency and effectiveness). Cohen’s effect size was calculated using the standardized response mean (SRM) to quantify the change. Results: The age range of the parents was 31–50 (72%), including 31 mothers (96.9%). Median differences between the two administrations were significantly different (p < .05). The MCID were 11.34, 9.82, and 4.48; the SRM were 0.42, 0.54, and 0.04, for the LPP total score, efficiency subscale and effectiveness subscale, respectively. Conclusions: The LPP is responsive to detect a change larger than measurement error in parental ability of participating in life occupations while raising a child with disabilities.

Predictors of meaningful improvement in quality of life after selective amygdalohippocampectomy in Chinese patients with refractory temporal lobe epilepsy: A prospective study

Patient-Reported Quality of Life (QoL) Following CTL019 Infusion in Adult Patients (pts) with Relapsed/Refractory (r/r) Diffuse Large B-Cell Lymphoma (DLBCL)

Preoperative patient factors that predict achieving the minimal clinically important difference following arthroscopic treatment of snapping scapula syndrome

Background and Objectives: Unicompartmental knee arthroplasty (UKA) is a valid alternative to total knee arthroplasties (TKAs) in selected cases. After surgery, patients’ experience and satisfaction were traditionally evaluated by pre- and postsurgical scores and Patient-Reported Outcome Measures (PROMs). Otherwise, a statistically significant change does not necessarily correlate to a clinically meaningful improvement when measured using PROMs. To evaluate the real effect of a specific treatment and understand the difference between groups in a clinical trial, it is necessary to use a meaningful quantum of change on the score assessed. The minimal clinically important difference (MCID) and the Patient Acceptable Symptom State (PASS) can provide this meaningful change. This paper aimed to calculate the MCID and the PASS of the Forgotten Joint Score (FJS-12) after UKA. Materials and Methods: A total of 40 patients with a mean age 72.5 ± 6.4 years undergoing UKA were assessed preoperatively and six months postsurgery using the FJS-12 and the Oxford Knee Score (OKS). The baseline and 6-month postoperative scores were compared using the Wilcoxon signed ranks test. The correlation was calculated with Spearman’s rho. Both distribution-based approaches and anchor approaches were used to estimate MCID for the FJS-12. The 75th percentile and the Receiver operating characteristic (ROC) curve methods were used to calculate the PASS of FJS-12. Results: MCID estimates for normalized FJS-12 for UKA ranged from 5.68 to 19.82. The threshold of the FJS-12 with ROC method was 72.92 (AUC = 0.76). The cut-off value computed with the 75th percentile approach was 92.71. Conclusions: The MCID and PASS represent valid tools to assess the real perception of clinical improvement in patients who underwent UKA. The MCID value of FJS-12 was 12.5 for patients who underwent UKA. The value of the PASS for the FJS-12 in patients who underwent UKA was 72.92.