Quality Of Life Response Research Articles

562 “A Long process:” a Qualitative Analysis of Burn Survivors’ Treatment and Recovery Process

Abstract Introduction The treatment and recovery from a burn injury is a long process that can affect a survivor’s appearance, mobility, daily function, and emotional wellbeing. In this study, we sought to identify various factors in survivors’ treatment and recovery process. Methods We conducted thematic analysis on transcripts of in-depth, semi-structured interviews with 11 burn survivors who had been treated at a Midwest tertiary facility. Survivors were purposefully selected for variability in age, gender, injury size, injury mechanism and quality of life responses. All transcripts were coded by at least two authors. We managed coded results in MAXQda, a qualitative data management software program. Results The mean age of interviewees was 51 years (35–63 years) and time from the injury was 5.4 years (2 months to 26 years). Their burn sizes ranged from < 10% in 4 people to 70–79% in one. Participants reported varied perceptions of care quality and provider relationships from the initial hospital stay. Some recalled communication issues from the hospital throughout the long recovery process. Many used graphic terms for the unfamiliar treatment methods. Survivors reported ongoing issues with their skin and mobility that continued to impact activities of daily living even years later. Many did not have clear or realistic expectations or understanding of the recovery process. Wound care was overwhelming and provoked fear for many survivors even with formal instruction. Most participants developed different ways to treat their injuries at home. Barriers to recovery included finances, comorbidities, and environmental characteristics, including rurality. Conclusions Even years later, the burn injury can continue to evolve, create fears, and affect daily living for survivors. To help patients understand the realistic course of recovery, providers could focus on clear communication about the injury and recovery. Providers should recognize survivors with barriers who may need referrals for further support. Applicability of Research to Practice Reflecting on the subjective accounts of survivors will help identify opportunities to improve patient experiences during treatment and throughout the recovery process.

Effects of Microecological Preparations on Obese Patients after Bariatric Surgery: A Systematic Review and Meta-Analysis.

Vitamin deficiency, bacterial overgrowth, and gastrointestinal symptoms can be detected in obese patients after bariatric surgery that influences their quality of life (QoL) and weight. It is unclear if microecological preparations benefit obese patients following bariatric surgery. The aim of this study is to investigate the effects of microecological preparations on QoL, excess weight loss (EWL), and levels of vitamin B12 and inflammatory markers. We searched seven databases to identify reports published till December 1, 2019, and included randomized controlled trials investigating the effects of microecological preparations in obese adults undergoing bariatric surgery. The primary outcomes included QoL and EWL, while secondary outcomes comprised serum levels of vitamin B12, interleukin 6, TNF-α, and C-reactive protein (CRP). Study bias was analyzed using the Cochrane risk-of-bias tool. Statistical analyses were performed using Review Manager. The mean difference in outcomes was calculated using standardized mean difference (SMD) with a confidence interval (CI) of 95%. A majority of the studies showed a low or moderate risk of bias. Meta-analysis showed significantly higher levels of vitamin B12 in postoperative patients administered with microecological preparations (SMD = 0.52; 95% CI = 0.08–0.95; P = 0.02). There were no significant differences in QoL (SMD = −0.14; 95% CI = −0.45–0.17; P = 0.38), EWL (SMD = 0.45; 95% CI = −0.16–1.05; P = 0.15), and levels of TNF-α (SMD = −0.29; 95% CI = −0.64–0.05; P = 0.09), interleukin 6 (SMD = −0.1; 95% CI = −0.81–0.61; P = 0.78]), and CRP (SMD = 0.02; 95% CI = −0.32–0.36; P = 0.93). The trials examined indicated that microecological preparations had limited efficacy in improving QoL, EWL, and inflammatory response, but they stimulated the synthesis of vitamin B12. This may help in designing efficient microecological preparations to supplement bariatric surgery in obese individuals.

Patient outcomes after radiofrequency ablation stratified by Clinical, Etiology, Anatomy, and Pathophysiology classification

ObjectiveVenous insufficiency is a prevalent and potentially debilitating disease. Treatment guidelines and techniques such as radiofrequency ablation (RFA) developed in the United States and Europe have been shown to provide significant improvements in quality of life; however, these have not been clearly assessed in the populations of developing nations. This study examined quality of life outcomes after RFA of patients treated at a single Jamaican vein center. MethodsIn this study, 100 patients who underwent RFA from 2007 to 2012 were evaluated. Patients answered the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) questionnaire assessing quality of life before and after RFA. Improvements in specific categories, such as venous symptoms, work limitations, social limitations, and cosmetic concerns, were evaluated. Cumulative VEINES-Sym and VEINES-QOL scores were also assessed. ResultsPatients' quality of life responses were significantly improved in every individual VEINES question. Average cumulative VEINES-Sym t score improved 9.96 points (P < .01), and VEINES-QOL t score improved 11.15 points (P < .01). For patients with Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) C5 and C6 disease, the only questions that did not show significant improvement were limitations to daily workplace activity and impact on clothing after RFA. However, in this subset, the average VEINES-Sym t score improved 11.83 points (P < .01), and the VEINES-QOL t score improved 11.96 points (P < .01) after RFA. ConclusionsVenous disease is often overlooked, and access to treatment can be limited in developing nations. This study demonstrated that venous treatment guidelines and RFA techniques developed in the United States and Europe could be successfully applied to a Jamaican population, resulting in significant improvements in quality of life.

Wharton's Jelly Mesenchymal Stem Cell Administration Improves Quality of Life and Self-Sufficiency in Children with Cerebral Palsy: Results from a Retrospective Study.

The aim of this paper was to describe the outcome of the therapeutic administration of allogenic mesenchymal stem cells obtained from Wharton's jelly (WJ-MSCs) in children with cerebral palsy (CP) during a medical therapeutic experiment. We retrospectively analyzed the records of 109 patients recruited in daily clinical practice. Each patient received 1–10 injections and was examined by the same neurologist (study investigator (SI)) on the day of each infusion. The SI used a 6-point Likert scale to assess the quality of life (QoL) and self-sufficiency of the patients on the basis of the neurological examination. Children with >50% follow-ups after this administration were included into the quantitative analysis. In addition, the assessments of the parents and other health care professionals were obtained for 23 patients and compared with those of the SI. Forty-eight of 54 analyzed patients (88.9%) achieved some improvement in health status. Forty-eight (88.9%) patients experienced an increase in their QoL, and 21 patients (38.9%) achieved an increase in their self-sufficiency level. Improvement was achieved in 17 areas. Adverse events were mild and temporary except one case of epilepsy deterioration leading to treatment discontinuation. Age, body mass, and cell dose were not significant predictors of QoL response, contrary to epilepsy; developmental breakthrough was dose-dependent.

Pyloric distensibility measurement predicts symptomatic response to intrapyloric botulinum toxin injection

Recent studies have reported that pyloric distensibility was altered in 30% to 50% of patients with gastroparesis, and this was correlated with gastric emptying and symptom severity. The aim of this study was to assess whether pyloric distensibility measurement was predictive of symptomatic response after intrapyloric botulinum toxin (BT) injection. Pyloric distensibility was measured using the EndoFLIP system (Crospon, Galway, Ireland) before intrapyloric BT injection. Altered pyloric distensibility was defined as distensibility below 10mm2/mm Hg. Total symptomatic score (TSS), dyspeptic symptoms, Gastrointestinal Quality of Life Index (GIQLI), and gastric emptying were investigated prospectively before and 3 months after BT injection. Nineteen of 35 patients had altered pyloric distensibility. In those patients, TSS decreased at 3 months from 13.5 to 10.5 (P< .01), whereas it remained unchanged in patients with normal pyloric distensibility (P= .7). Gastric fullness (from 3.5 to 2.5; P= .03) and bloating (from 3.0 to 2.0; P= .01) were the only symptoms that improved in patients with altered pyloric distensibility, whereas none of them was improved in patients with normal pyloric distensibility. GIQLI score increased from 59.5 to 76.5 in patients with altered pyloric distensibility (P= .02), whereas there was no statistical difference (P= .43) in patients with normal pyloric distensibility. In patients with altered pyloric distensibility, gastric emptying half time was 223 minutes before and 190 minutes 3 months after injection (P= .02), whereas it remained unchanged in patients with normal pyloric distensibility (P= .6). Pyloric distensibility measurement before intrapyloric BT injection predicted symptomatic and quality of life response 3 months after injection in patients with gastroparesis.

Low-FODMAP Diet Is Associated With Improved Quality of Life in IBS Patients-A Prospective Observational Study.

The low fermentable oligosaccharide, disaccharide, monosaccharide, and polyol (FODMAP) diet is effectively manages irritable bowel syndrome (IBS) symptoms. Long-term low-FODMAP studies rarely report quality of life (QoL). We aimed to determine the effect of low-FODMAP diet on long-term QoL, gastrointestinal (GI) and non-GI symptoms in IBS patients. A prospective observational study of IBS patients referred for low-FODMAP dietary advice was performed. The primary outcome of QoL and secondary outcomes of GI symptoms, anxiety/depression, fatigue, sleep quality, and happiness were obtained at baseline, 6 weeks (T6), and 6 months (T26). 111 patients were recruited. 91.0%, 71.6%, and 50.5% of participants completed baseline, T6, and T26 assessments, respectively. There were significant improvements in QoL from baseline at T6 and T26 (both P < 0.001). Significant reductions were seen in GI symptoms at T6 and T26 (both P < 0.001), fatigue at T6 and T26 (both P < 0.003), and anxiety at T6 and T26 (both P < 0.007), compared with baseline. A significant reduction was seen for depression (P<0.010) from baseline at T26, and a significant increase was seen for both happiness and vitality (both P < 0.04) from baseline at T26. There was a significant correlation between GI symptom response and change in QoL, anxiety, depression, and fatigue (all P < 0.034). Low-FODMAP diet was associated with improved long-term QoL and GI symptoms, reduced fatigue and anxiety/depression, and increased happiness and vitality. These data support a wider range of benefits for IBS patients consuming a low-FODMAP diet.

A Comprehensive Conceptual Model of the Experience of Chronic Itch in Adults.

Itch is common and often debilitating. Itch is best assessed by self-report, often using patient-reported outcome measures (PROMs). Current PROMs for itch are limited and may not capture its full impact on quality of life (QOL). We sought to develop a comprehensive conceptual model of itch to improve the understanding of itch for clinicians and to serve as a framework for development of efficient and valid PROMs of itch. Using mixed methods, including systematic review (n = 491 articles), semi-structured interviews (n = 33 adults with chronic itch with multiple etiologies), and grounded theory using a constant comparative approach, we developed a conceptual model of itch. We found the Wilson and Cleary model to be a reasonable framework for organizing our findings. It includes five primary components: biological and physiological variables, symptom status, functional status, general health perceptions, and QOL. We propose a causal relationship beginning with the biological and physiological driving factors, with direct and indirect impacts of itch and its sequelae, including pain and sleep disturbance. These can impair function, lead to task avoidance, stigma, social life and relationship problems, emotional disturbances, and treatment burden. Together, these sequelae alter one's perceptions of health, QOL, and treatment response. Our conceptual model demonstrates the profound patient-burden of itch and identifies unmet needs in the evaluation and management of itch.

Continuous Clinical Response Is Associated With a Change of Disease Course in Patients With Moderate to Severe Ulcerative Colitis Treated With Golimumab

Responders to induction treatment sustain continuous clinical response (CCR) through 1 year in about 50% of patients in PURSUIT-M trial with golimumab maintenance in ulcerative colitis (UC). This post hoc analysis of PURSUIT-M describes the 1-year clinical, endoscopic, quality of life (QoL), and biomarker and 4-year clinical outcome in patients with sustained response to golimumab therapy for UC. We compared clinical, endoscopic, QoL, and calprotectin outcomes in CCR and non-CCR patients through 54 weeks in PURSUIT-M. Persistence on golimumab therapy and clinical response at 4 years was assessed for CCR and non-CCR patients. The relationship of colectomy with CCR status was determined. Among patients receiving golimumab maintenance, greater proportions of patients with vs without CCR at week 54 achieved clinical remission (67.1% vs 1.9%), corticosteroid-free remission (61.6% vs 1.9%), endoscopic remission (Mayo endoscopy score 0 [47.9% vs 1.3%]), and normal QoL (inflammatory bowel disease questionnaire score ≥170 [75.0% vs 24.4%]). CCR but not non-CCR patients maintained normalized calprotectin levels during maintenance. Among patients who entered the long-term extension study, a greater proportion of patients with vs without CCR maintained PGA 0 through week 216 (58% vs 42%). Colectomy was performed in 47 induction nonresponders and in 13 induction responders. None of the patients going onto colectomy achieved CCR through 54 weeks in PURSUIT-M. Continuous clinical response is associated with favorable short- and long-term clinical, endoscopic, QoL, and biomarker responses that may result in changing the course of disease and may prevent colectomy in patients with moderate to severe UC treated with golimumab. 10.1093/ibd/izy229_video1izy229.video15806022773001.

Prospective evaluation of patient reported swallow function with the Functional Assessment of Cancer Therapy (FACT), MD Anderson Dysphagia Inventory (MDADI) and the Sydney Swallow Questionnaire (SSQ) in head and neck cancer patients

ObjectivesThe Functional Assessment of Cancer Therapy (FACT) instrument is comprised of a group of related and overlapping quality of life (QoL) questionnaires including a core general form, head and neck cancer (HNC)-specific items, and an expert-selected index (FACT-HNSI). Understanding how these relate to more HNC-specific instruments such as the MD Anderson Dysphagia Inventory (MDADI) and Sydney Swallow Questionnaire (SSQ) is vital for guiding their use in clinical trials. Materials and methodsHNC patients concurrently completed MDADI, SSQ, and FACT questionnaires at radiation oncology clinic visits (2015–2016). Spearman correlation coefficients were calculated between each FACT instrument and MDADI or SSQ. Unsupervised k-means cluster analyses were performed to identify clusters of similar QoL responses. Principal component analysis (PCA) identified the degree of variability explained by each instrument. ResultsWe identified 631 instances (363 patients) where the questionnaires were completed concurrently. Correlations between the various FACT measures and SSQ or MDADI were all significant (p < 0.001), but FACT HNC-specific subscale and FACT-HNSI showed the strongest correlation with MDADI and SSQ. Clustering identified 3 distinct groups of responses when combining instruments either pairwise or three-way. PCA revealed that MDADI and FACT HNC-specific subscale provide similar and likely redundant information. ConclusionFACT HNC-subscale and FACT-HNSI may be preferable over other FACT measures for use in clinical trials where patient-reported swallow function is evaluated. MDADI and FACT provide similar insights into HNC patient QoL while SSQ provides additional, complementary information which could serve to better stratify patients into groups with high, medium, and low QoL outcomes.

Effect of supplemental vibration on orthodontic treatment with aligners: A randomized trial.

Supplemental vibration has been reported to accelerate orthodontic tooth movement and reduce discomfort. Our purpose was to investigate the effects of AcceleDent on Invisalign treatment. This randomized clinical trial was carried out in 2 orthodontic private practices with a 1:1 allocation ratio. Adult patients who were beginning their orthodontic treatment were randomly allocated to either an active (A) or a sham (B) AcceleDent Auradevice (OrthoAccel Technologies, Inc. Houston, TX). All patients were placed on a 1-week aligner change regimen, and fit was evaluated every 3weeks. The outcomes were the ability to complete the initial set of aligners and the incisor irregularity measurements for those who completed their regimen of aligners. In addition, aligner compliance, pain levels, and oral health-related quality of life data were gathered from questionnaires. The subjects, investigators, and assessors were all blinded to the treatment arms. Twenty-seven subjects were randomized into 2 groups (A and B), 1 subject discontinued treatment, and 13 subjects were analyzed in each group. The Fisher exact test showed no significant difference in completion rates between the 2 groups (group A, 77%; group B, 85%; P=1). Independent-sample t tests showed no significant difference between the final irregularity index or change in irregularity index between the 2 groups. Compliance was similar in both groups. The Wilcoxon rank sum test showed minimal differences in pain levels. Quality of life responses were similar in both groups. No serious harm was observed. We found no evidence that the AcceleDent Aura device impacts the ability to complete a series of aligners with a 1-week change regimen or the final alignment achieved in adult patients. It also had no significant effect on the reduction of orthodontic pain or oral health-related quality of life parameters when used with Invisalign.

Quality of life in thyroid cancer—assessment of physician perceptions

BackgroundThyroid cancer is the fastest growing malignancy in the United States. Previous studies have shown a decrease in quality of life (QoL) after the treatment of thyroid cancer. To date, there have been no studies assessing physician perceptions regarding how a diagnosis of thyroid cancer affects QoL. Based on this and other findings from our study, we aim to assess physician perceptions on the effect of thyroid cancer on QoL. Materials and methodsPhysicians were recruited from two national organizations comprised physicians focusing on thyroid cancer. A 37-question survey was administered evaluating physician's perceptions of thyroid cancer patient satisfaction in various aspects of treatment, complications, and overall effects on QoL. QoL responses were categorized into overall QoL, physical, psychological, social, and spiritual well-being. ResultsOne hundred five physicians completed the survey. Physician's estimates of patient's overall QoL after thyroid cancer treatment was similar to overall QoL reported by patients. However, medical physicians overestimated the decrease in thyroid cancer survivor's QoL in several subcategories including physical, psychological, and social (P < 0.05). Both surgeons and medical physicians underestimated the percentage of patients with reported symptoms of temporary and permanent voice changes, temporary dry mouth, cold/heat sensitivity, and temporary and permanent hypocalcemia (P = 0.01-0.04). ConclusionsPhysicians have a varied estimation of the detrimental impact of thyroid cancer treatment on QoL. In addition, physicians underestimated the amount of physical symptoms associated with thyroid cancer treatments. Increased physician awareness of the detrimental effects of a thyroid cancer diagnosis on QoL should allow for a more accurate conversation about expected outcomes after thyroid cancer treatment.

Evaluation of health status in patients with hepatitis c treated with and without interferon

BackgroundThe evolution of technology in healthcare has increased the health care’s costs and, the universal healthcare systems, in developed countries, need to ensure proper allocation of resources. Thus, the major issue is assessing the effectiveness of new medical technologies. The evaluation of quality of life in response to new treatments has become a key indicator in chronic conditions for which medical interventions are evaluated not only in terms of increasing the number of expected life years but also in terms of increasing quality of life. The aim of this observational study was to verify whether a simple instrument (EQ-5D-5 L) can capture variations in health-related quality of life (HRQoL) and allow us to evaluate the impact of different drug treatment protocols in patients with hepatitis C virus (HCV) on daily activities.MethodsSixty six patients with HCV were consecutively enrolled in the Hepatology Unit at the University Hospital of Catania “G. Rodolico”. Sixteen patients received new direct-acting-antiviral agents (DAAs) plus pegylated alpha interferon (Peg-α-IFN) protocol (Group A) and 50 DAAs IFN free protocol (Group B).The EQ-5D-5 L® questionnaire and visual analog scale (VAS) were given to both groups to calculate coefficient’s utility. We used the EQ-5D-5 L Crosswalk Index Value Calculator to obtain the utility EQIndex and both parametric and non parametric tests for the statistical analysis.ResultsThe biopsy taken at the beginning of treatment showed comparable cell damage in both groups. The difference in the VAS results was negative for patients who received protocols containing IFN (indicating decreased quality of life),whereas it was positive in patients treated with IFN-free protocols. The baseline EQIndex did not reveal any differences between the two treatment groups. The post-treatment EQIndex was statistically better in the groups that received IFN-free therapy.ConclusionsWhen innovative treatments are introduced into clinical practice, assessing quality of life is mandatory to determine their benefits. The instruments used in the present study are effective in detecting the areas in which improvement has occurred. These instruments can be easily managed by general practitioners for follow up of progression of the disease and referred to the specialist.

Effects of Aidi Injection () with Western Medical Therapies on Quality of Life for Patients with Primary Liver Cancer: A Systematic Review and Meta-Analysis.

To evaluate the effects of Aidi Injection (, AD) in combination with Western medical therapies (WMT) in patients with primary liver cancer (PLC). Randomized controlled trials (RCTs) comparing AD plus WMT with WMT alone were retrieved from inception to March 2013 by retrieving the literature database thoroughly and systematically. The extracted data from included studies were analyzed and synthesized by Review Manager 5.2 software. The Cochrane risk of bias tool was used to assess the quality of included studies, and Begg's and Egger's tests were used to evaluate the potential presence of publication bias. The studies were divided into 7 separate subgroups in terms of quality of life (QOL), recent chemotherapy and the incidence of leukocyte reduction. The subgroup analysis was applied to assess the heterogeneity between included researches, and the sensitivity analysis was used to weigh the stability of studies. Twenty-four RCTs were included in this study. Compared with WMT used alone, AD as additional intervention was more effective on improving QOL (P<0.01), increasing short-term efficacy (P<0.01), prolonging life (P<0.05 or P<0.01), relieving clinical symptoms (P<0.01), and reducing adverse events (e.g. reduce white blood cell counts, P=0.002; reduce in platelet counts, P<0.01). Subgroup analysis showed that the hepatic artery interventions with AD was superior in improving QOL (P<0.01) and enhancing short-term response rates (P=0.007) and reducing white blood cell counts (P=0.0004) than hepatic artery interventions alone (P<0.01). The chemoembolization plus AD or the chemotherapy plus AD were both better than chemoembolization or the chemotherapy alone in improving the QOL and short-term response rate (P<0.05 or P<0.01). AD in combination with WMT improves QOL in patients with PLC. Considering the inherent limitations of the included studies, further well-designed, rigorously performed, high-quality, and double-blinded RCTs with large sample sizes are needed.

Genetic biomarkers associated with changes in quality of life and pain following palliative radiotherapy in patients with bone metastases.

Patients with bone metastases undergoing palliative radiation therapy (RT) may experience changes in both the functional and symptomatic aspects of quality of life (QOL). The European Organization of Cancer Research and Treatment (EORTC) QOL Questionnaire Core-15 Palliative (QLQ-C15-PAL) is a validated questionnaire employed to assess QOL specifically in palliative patients. Our study aimed to identify single-nucleotide variant (SNV) genetic biomarkers associated with changes in QOL and pain. Fifty-two patients who received a single 8-Gy RT for painful bone metastases completed the EORTC QOL-C15-PAL questionnaire prior to randomization and at 42-day post RT. Saliva samples obtained at day of RT were sequenced, and SNVs from genes involved in inflammation, radiation response, immune response, DNA damage, or QOL were assessed for association with changes in global QOL or the pain scale items using the Cochran-Armitage trend test. The penalized LASSO method with minimum Bayesian information criterion was used to select a multi-SNV model out of significant SNVs (P<0.005) and to produce prognostic scores for patients that categorized them into risk groups of low, middle, and high. The multivariable model predicting global QOL included 14 SNVs, of which HS1BP3 rs35579164 G:C and ABCA1 rs2230805 C>T had the largest positive and negative effect sizes, respectively (HS1BP3: 8.21, ABCA1: -3.44). The model for the response of QOL pain item included 8 SNVs, of which PLAUR rs4760 A>G and ELAC2rs11545302 had the largest positive and negative effect sizes, respectively (PLAUR: 5.23; ELAC: -3.84). The patients' risk groups were highly predictive of QOL response (P<0.0001) and pain item response (P<0.0001). In logistic regression analysis accounting for baseline factors of gender and primary cancer site, the global QOL risk group predicts pain response after RT [OR: 2.1, 95% confidence interval (CI): 1.2-3.9, P=0.015], but the QOL pain item risk group did not (OR: 0.93; 95% CI: 0.5-1.6, P=0.79). The multi-SNVs model included SNVs from genes involved in metabolism, membrane transport, cell cycle control, ciliary structure, and gene expression regulation. SNVs were significantly associated with changes in global QOL of global domain and pain item in patients with bone metastases. Identification of genetic biomarkers predictive of QOL items may allow patients and health care providers anticipate and better address the needs of the palliative cancer patient population.

P1.01-056 Quality of Life and Clinical Outcomes of Nivolumab as 2+ Line Treatment in Advanced Refractory NSCLC Pts: Interim Analysis

We aimed to evaluate quality of life (QoL) and clinical outcomes of nivolumab (Nivo) as ≥ 2nd line treatment within the expanded access program in NSCLC pts. The QoL changes, response rates, survival and safety were studied within the multicenter prospective observational study.

ACE and response to pulmonary rehabilitation in COPD: two observational studies

IntroductionSkeletal muscle impairment is an important feature of chronic obstructive pulmonary disease (COPD). Renin–angiotensin system activity influences muscle phenotype, so we wished to investigate whether it affects the response to...

177Lu-DOTATATE treatment in neuroendocrine tumors. A preliminary study

Therapy with radiolabelled somatostatin analog peptides is a promising new therapy to treat neuroendocrine tumors. The aim of this preliminary study is to present our experience with 177Lu-DOTATATE therapy, and evaluate tolerability and short-term efficacy in patients with tumors expressing somatostatin receptors. A total of 7 patients with metastatic neuroendocrine tumors were treated, each with 4 doses of 177Lu-DOTATATE. The treatment response was evaluated in the form of biochemical response (tumor markers), imaging methods (somatostatin receptor scintigraphy, computed tomography, and magnetic resonance), and functional and quality of life responses using the Karnofsky performance status scale. Treatment toxicity was also evaluated. The results obtained were as follows: Biochemical response: 60% of patients showed tumor marker levels returning to normal, while they decreased significantly in the remaining 40%. Imaging response: 85.7% had a partial response, while 14.3% showed stable disease. All (100%) patients showed a significant improvement in quality of life, with increased Karnofsky scale scores. No patient had acute or chronic toxicity, and subacute transient hematological toxicity was observed in 42.8% of patients. Despite being a preliminary study, it was found that treatment with 177Lu-DOTATATE is a safe treatment with few side effects, and an objective response was achieved in most patients.

Abstract 224: Characterizing Quality of Life Responses and Physical Functioning Improvements to an Integrated Self-care Intervention for Persons With Co-morbid Heart Failure and Diabetes

Objectives: In the Quality HF-DM trial, which tested an integrated self-care intervention for persons with heart failure (HF) and diabetes (DM), improved perceived HF and general health-related quality of life (QOL) and physical functioning were observed, but not for DM QOL. However, some participants did improve. This analysis examined the demographic and clinical factors associated with positive and clinically meaningful change in outcomes in response to the intervention to help inform future improvement in targeted interventions. Methods: HF-DM participants (n=134), mean age 57.4 ± 11 years, 66% men, 69% African American, were randomized to usual care (UC) or intervention (INT) with assessments at baseline (BL), 1, 3 and 6 months (M). Intervention included education/counseling focused on HF-DM self-care. Variables (measures, clinically meaningful change between BL-6 M) were: HF QOL (MLHFQ &amp;gt5), general QOL (EQ5D-index &amp;gt0.1; EQ5D-VAS &amp;gt10), DM QOL (ADDQOL, &amp;gt1), physical function (6 Minute Walk Test [6MWT] &amp;gt50 meters). Age, gender, race, education, living arrangements, NYHA class and time with HF and DM were evaluated after adjusting for the INT group using linear and logistic regression to assess for relationship to improvements in outcomes. Results: For general QOL EQ5D index scores, those with less education (high school or less) (p=.024); those with NYHA class 3 or 4 (p=.036); and those with DM longer (p=.011) improved more. For MLWHF scores, whites were more likely than African Americans to improve their MLWHF scores (p=.05). For DM QOL (ADDQOL), 35% of younger participants (&amp;lt=58 yrs.) in the intervention group improved their ADDQOL scores by 1 or more points compared to only 10% of the older participants (&amp;gt58 yrs.) (p=.039). For 6MWT distances, males in INT group more likely to achieve improvement (p=.014), and those with NYHA class 3 or 4 more likely to improve (p=.048). Conclusions: When considering QOL and physical function outcomes in response to an HF-DM self-care intervention, age, education, race, gender, NYHA class, and time with DM were important. The INT improved outcomes in vulnerable groups of lower education, greater HF severity, and longer times with DM. Effects differed by EQ5D, MLWHF and ADDQOL measures highlighting the importance of evaluating multiple general and disease specific QOL dimensions, and the need to consider demographic and clinical risk factors to tailor toward more precise interventions.

Using Quality of Life Scales with Nutritional Relevance after Gastrectomy: a Challenge for Providing Personalized Treatment.

PurposeThis study evaluated the changes in nutritional status based on quality of life (QoL) item-level analysis to determine whether individual QoL responses might facilitate personal clinical impact.Materials and MethodsThis study retrospectively evaluated QoL data obtained by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) and Quality of Life Questionnaire-Stomach (QLQ-STO22) as well as metabolic-nutritional data obtained by bioelectrical impedance analysis and blood tests. Patients were assessed preoperatively and at the 5-year follow-up. QoL was analyzed at the level of the constituent items. The patients were categorized into vulnerable and non-vulnerable QoL groups for each scale based on their responses to the QoL items and changes in the metabolic-nutritional indices were compared.ResultsMultiple shortcomings in the metabolic-nutritional indices were observed in the vulnerable groups for nausea/vomiting (waist-hip ratio, degree of obesity), dyspnea (hemoglobin, iron), constipation (body fat mass, percent body fat), dysphagia (body fat mass, percent body fat), reflux (body weight, hemoglobin), dry mouth (percent body fat, waist-hip ratio), and taste (body weight, total body water, soft lean mass, body fat mass). The shortcomings in a single index were observed in the vulnerable groups for emotional functioning and pain (EORTC QLQ-C30) and for eating restrictions (EORTC QLQ-STO22).ConclusionsLong-term postoperative QoL deterioration in emotional functioning, nausea/vomiting, pain, dyspnea, constipation, dysphagia, reflux, eating restrictions, dry mouth, and taste were associated with nutritional shortcomings. QoL item-level analysis, instead of scale-level analysis, may help to facilitate personalized treatment for individual QoL respondents.

Changes of quality of life and cognitive function in individuals with Internet gaming disorder: A 6-month follow-up.

Internet gaming disorder (IGD) contributes to poor quality of life (QOL) and cognitive dysfunction and is increasingly recognized as a social problem in various countries. However, no evidence exists to determine whether QOL and cognitive dysfunction stabilize after appropriate management. The present study addressed improvement in QOL and cognitive functioning associated with changes in addiction symptoms following outpatient management for IGD. A total of 84 young males (IGD group: N = 44, mean age: 19.159 ± 5.216 years; healthy control group: N = 40, mean age: 21.375 ± 6.307 years) participated in this study. We administered self-report questionnaires at baseline to assess clinical and psychological characteristics, and conducted traditional and computerized neuropsychological tests. Nineteen patients with IGD completed follow-up tests in the same manner after 6 months of outpatient treatment, which included pharmacotherapy with selective serotonin reuptake inhibitors. A baseline comparison of patients with IGD against the healthy control group showed that the IGD patients had more symptoms of depression and anxiety, higher degrees of impulsiveness and anger/aggression, higher levels of distress, poorer QOL, and impaired response inhibition. After 6 months of treatment, patients with IGD showed significant improvements in the severity of IGD, as well as in QOL, response inhibition, and executive functioning. Additionally, a stepwise multiple regression analysis revealed a favorable prognosis for IGD patients with low working memory functioning and high executive functioning at baseline. These results provide evidence regarding longitudinal changes in QOL and cognitive function following psychiatric intervention for IGD. Furthermore, it appears that response inhibition may be an objective state marker underlying the pathophysiology of IGD.