Health-related quality of life measures provide information on the contributors, components, and consequences of frailty in HIV: a systematic mapping review.

PURPOSE: Frailty in HIV is extensively explored in epidemiological and clinical studies; it is infrequently assessed as an outcome in routine care. The focus on health-related quality of life (HRQL) measures in HIV presents a unique opportunity to understand frailty at a larger scale. The objective was to identify the extent to which generic and HIV-related HRQL measures capture information relevant to frailty. METHODS: A systematic mapping review using directed and summative content analyses was conducted. An online search in PubMed/Medline identified publications on frailty indices and generic and HIV-related HRQL measures. Directed content analysis involved identifying contributors, components, and consequences of frailty from the frailty indices based on the International Classification of Functioning, Disability, and Health framework. Summative content analysis summarized the results numerically. RESULTS: Electronic and hand search identified 447 review publications for frailty indices; nine reviews that included a total of 135 unique frailty indices. The search for generic and HIV-related HRQL measures identified 2008 records; five reviews that identified 35 HRQL measures (HIV-specific: 17; generic: 18). Of the 135 frailty indices, 88 cover more than one frailty dimension and 47 cover only physical frailty. Contributors to frailty, like sensory symptoms and nutrition, are extensively covered. Components of frailty such as physical capacity, cognitive ability, and mood are also extensively covered. Consequences of frailty namely self-rated health, falls, hospitalization, and health services utilization are incomprehensively covered. HRQL measures are informative for contributing factors, components of frailty, and a consequence of frailty. CONCLUSION: HRQL items and measures show a strong potential to operationalize multidimensional frailty and physical frailty. The study suggests that these measures, connected to evidence-based interventions, could be pivotal in directing resources toward vulnerable populations to mitigate the onset of frailty.

Safety and efficacy of monthly high-dose vitamin D3 supplementation in children and adolescents with sickle cell disease.

Little is known about the impact of vitamin D supplementation on hand grip strength (HGS) and health-related quality of life (HRQoL) in children and adolescents with sickle cell disease (SCD). We aimed to evaluate the safety and efficacy of monthly high-dose vitamin D3 supplementation and its implications on bone mineral density (BMD), HGS, and HRQoL in patients with SCD and healthy controls. The study included 42 children with SCD and 42 healthy matched controls. The study participants were supplemented with high-dose monthly oral vitamin D3. Changes in the serum level of 25(OH) vitamin D3, maximum HGS, and BMD from baseline to 6 months were assessed, and the HRQoL questionnaire and Childhood Health Assessment Questionnaire (CHAQ) were used to evaluate the functional capacity. At baseline, SCD subjects had poorer growth status indicated by negative Z scores. Suboptimal BMD was detected by significantly lower Z score, and lower HGS and worse HRQL parameters were found compared to the controls (P < 0.001). Median 25(OH) vitamin D3 was significantly lower in SCD patients compared to controls (16.5 vs. 28 ng/mL, respectively (P < 0.001)). After 6 months of vitamin D supplementation, there was significant improvement in the DEXA Z-score (P < 0.001), limitation of physical health (P = 0.02), pain scores (P < 0.001), and CHAQ grades (P = 0.01) in SCD patients. A significant improvement in HGS (P < 0.001 and P = 0.005) as well as the CHAQ score (P < 0.001 and P = 0.003) was detected in the SCD group and controls, respectively. There were no reported clinical adverse events (AEs) or new concomitant medications (CMs) during the study duration, and safe levels of Ca and 25 (OH) D3 were observed at 3 and 6 months for both groups. There was a significant positive correlation between HGS and total physical score (r = 0.831, P < 0.001) and a negative correlation with CHAQ score (r = - 0.685, P < 0.001). We also detected a significant positive correlation between vitamin D levels at 6 months and HGS (r = 0.584, P < 0.001), pain score (r = 0.446, P < 0.001), and a negative correlation with CHAQ score (r = - 0.399, P < 0.001).   Conclusion: Monthly oral high-dose vitamin D supplementation was safe and effective in improving vitamin D levels, HGS, and HRQoL in SCD children and healthy subjects, and BMD scores in SCD patients. Further randomized controlled trials are warranted to assess an optimal dosing strategy and to investigate the impact on clinically significant outcomes in children and adolescents with SCD and their healthy counterparts.   Trial registration: ClinicalTrials.gov , identifier NCT06274203, date of registration: 23/02/2024, retrospectively registered. What is known: • Several studies have reported a high prevalence of vitamin D deficiency and suboptimal bone mineral density (BMD) in sickle cell disease (SCD) patients. • Musculoskeletal dysfunction is reported in SCD patients with a negative impact on physical activity and health-related quality of life (HRQL). • Little is known regarding the impact of vitamin D3 supplementation in children and adolescents with SCD. What is new: • We found that monthly oral high-dose vitamin D3 supplementation was safe, tolerated, and effective in improving serum vitamin D levels, HGS, BMD scores, and HRQL in SCD patients.

Sex- and gender-specific differences in symptoms and health-related quality of life among patients with gastroesophageal reflux disease.

Gastroesophageal Reflux Disease (GERD) is a common chronic gastrointestinal disorder affecting both men and women. Nonerosive reflux disease generally affects more women, whereas GERD complications such as Barrett's esophagus (BE) or esophageal cancer affect more men. The aim of this study was to evaluate sex- and gender-specific symptoms and health-related quality of life (HRQoL) among men and women with GERD. Patients with clinical signs of reflux and completion of 24-hour pH-Impedance testing at the University Hospital Cologne were included into the study. Evaluation of symptoms and HRQoL included the following validated questionnaires: GERD-Health-Related Quality of Life (GERD HRQL), Gastrointestinal Quality of Life Index (GIQLI), and Hospital Anxiety and Depression Scale (HADS). In all, 509 women and 355 men with GERD were included. Men had a significantly higher DeMeester score (60.2 ± 62.6 vs. 43 ± 49.3, P < 0.001) and a higher incidence of BE (18.6 vs. 11.2%, P = 0.006). Women demonstrated significantly higher levels of anxiety (30.9 vs. 14.5%, P = 0.001), more severely impacting symptoms (45.3 ± 11.3 vs. 49.9 ± 12.3, P < 0.001), as well as physical (14.2 ± 5.7 vs. 16.7 ± 5.6, P < 0.001) and social dysfunction (13.3 ± 4.8 vs. 14.8 ± 4.3, P = 0.002). Women further reported a lower HRQoL (85.3 ± 22.7 vs. 92.9 ± 20.8, P < 0.001). Men and women differ on biological, psychological, and sociocultural levels.

Impact of interventions on the quality of life of cancer patients: a systematic review and meta-analysis of longitudinal research.

The impact of cancer interventions has been conducted in several research due to the significant burden of this non-communicable disease. The interventions that played an important role in the improvement of the patient's quality of life (QoL) and health-related quality of life (HRQL) can be classified into two main groups: pharmaceutical and non-pharmacological methods. However, studies so far often analyze a specific group of interventions for specific types of cancer. Thus, in this systematic review and meta-analysis, we synthesized the overall impact of cancer interventions on patients' quality of life in several cancers.In this research, we followed the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) to search the longitudinal original research on the Web of Science (WOS) database. After that, the Newcastle-Ottawa Scale (NOS) and Jadad Scale were used to assess the quality of non-randomized control trials and randomized control trials, respectively. Then, the characteristics of the included studies were described in the six main fields table and the random effect model with robust estimation was applied to analyze the impact of interventions on the health utility of patients.From the database, 122 longitudinal original research were included in the meta-regression, with most of them having high or fair quality. The European Organization for the research and treatment of cancer scale for quality of life (EORTC-QLQ) was the most used health utility measurement at 65.15%. In the adjusted effect models, the Visual Analogue Scale (VAS) had significant statistics in all models when we compared it with the EQ-5D Scale (p < 0.05) and several types of cancer such as breast, lung, and prostate cancer had significant statistics when comparing with hematological cancer in the model types of cancer (p < 0.01). Moreover, radiotherapy, screening, and a combination of chemotherapy and best supportive care also had significant statistics (p < 0.01) in the model of interventions when compared with radiotherapy applied only. Our research can suggest a vital combination of both pharmaceutical and non-pharmacological interventions to improve the quality of life of some common types of cancer patients.

GERD-screening before bariatric surgery: the predictive value of the GERD-HRQL questionnaire score compared with preoperative EGD findings.

BACKGROUND: There is an ongoing debate on how to best identify patients with gastroesophageal reflux disease (GERD) before bariatric surgery. The value of routine preoperative esophagogastroduodenoscopy (EGD) is questioned, and patient reported symptoms are commonly used for screening. The goal of this study is to determine if patient reported symptoms using a validated questionnaire correlate with preoperative EGD findings. METHODOLOGY: A prospective cohort study at a single institution was performed. Patients undergoing bariatric surgery between December 2020 and March 2023 were required to report symptoms of reflux by completing a preoperative GERD. Health-Related Quality of Life (GERD-HRQL) questionnaire and undergo a mandatory preoperative screening EGD. Patients were stratified into two cohorts: (group A) asymptomatic (score = 0) and (group B) symptomatic (score > 0). Statistical analysis was conducted using Pearson's chi-squared test and Wilcoxon rank-sum test in RStudio version 4.2.2. The predictive value of the GERD-HRQL score was analyzed using Areas Under the Curve (AUC; AUC = 0.5 not predictive, 0.5 < AUC ≥ 6 poor prediction & AUC > 0.9 excellent prediction) calculated from Receiver Operating Characteristic (ROC) curves. RESULTS: 200 patients were included; median age was 42.0 years (IQR 36.0 to 49.2). There were 79 patients (39.5%) in Group A and 121 patients (60.5%) in Group B. There was no difference in the frequency esophagitis (27.8% vs 32.2%, p = 0.61) or hiatal hernias (49.4% vs 47.1%, p = 0. 867) between group A and group B, respectively. ROC analysis revealed that the total GERD HRQL scores, heartburn only scores and regurgitation only scores, were poor predictors of esophagitis found on EGD (AUC 0.52, 0.53, 0.52), respectively. In asymptomatic patients, higher BMI was significantly associated with esophagitis (OR 1.15, 95% CI 1.06-1.27, p = 0.002). CONCLUSION: Symptoms, identified through the GERD-HRQL questionnaire, are a poor indicator of esophagitis or its severity in patients undergoing workup for bariatric surgery. Therefore, liberal screening upper endoscopy is recommended for pre-bariatric surgery patients to guide appropriate procedure selection.

25 Years of the GERD-HRQL symptom severity instrument: an assessment of published applications.

BACKGROUND: The GERD-HRQL symptom severity instrument was developed and published 25 years ago. This seems like an apropos time to review how the instrument has been used in the "real-world." METHODS: Google Scholar, PubMed, and Web of Science websites search was done using the keywords "GERD-HRQL" or its author, "Velanovich." Once articles were identified, the following information was obtained from each article: first author name, country of origin, journal published, year of publications, type of study design, subject of study, category of study, disease type studied, purpose of the study, how the GERD-HRQL scores were reported, how the GERD-HRQL scores were statistically reported, and results of the study. The total and change of scores were analyzed for descriptive statistics based on disease process studied and intervention studied. RESULTS: A total of 767 articles by 562 different first authors were identified in 193 different journals from 53 different countries of study origin. After a period of steady usages, the number of publication employing the GERD-HRQL has rapidly increase over the last 5 years. There have been 8 validated translations into other languages, although there appears to be numerous, non-validated ad hoc translations. Most commonly used or studied: observational cohort study design, surgical treatment study category, GERD disease process, treatment effect study purpose, total GERD-HRQL scores reported as means or medians. However, there were a wide variety of other study designs, study categories, disease processes, and study purposes. In general, GERD and laryngopharyngeal reflux had the high pre-treatment scores (i.e., more severe symptoms), and surgical and endoscopic interventions the lowest post-treatment score (i.e., least severe symptoms) with the largest change in score (i.e., treatment impact. CONCLUSIONS: The GERD-HRQL has proven to be a reliable, responsive and versatile symptom severity instrument for studies involving GERD as a subject.

Significant liver fibrosis is a predictor of poor health-related quality of life in people living with HIV.

PURPOSE: Liver-related comorbidities can impair the health-related quality of life (HRQL) in people living with human immunodeficiency virus (HIV) (PLWH). However, the role of hepatic steatosis and significant fibrosis in PLWH remains incompletely characterized. Therefore, the aim of this study was to explore the association of hepatic steatosis and significant fibrosis on the HRQL using the medical outcomes study HIV health survey (MOS-HIV) in PLWH. METHODS: A total of 222 PLWH were included in the final analysis of this cohort study. Metabolic comorbidities, socioeconomic factors, and HIV-related parameters were assessed. Hepatic steatosis and fibrosis were measured using vibration-controlled transient elastography (VCTE). The MOS-HIV survey, containing two summary scores (physical health summary (PHS) and mental health summary (MHS)) and ten domains, was used to assess the HRQL. Clinical predictors were identified using multivariable linear regression models. RESULTS: The majority of this cohort was male, and the median age was 52 years, with a high prevalence of hepatic steatosis (n = 81, 36.5%). Significant fibrosis was present in 7.7% (n = 17). The mean PHS and MHS scores were 52.7 ± 9.5 and 51.4 ± 10.5, respectively. The lowest scores were in the general health perception (GHP) and energy/fatigue (EF) domains. A high BMI and waist circumference were associated with a poor PHS score. Lower education, unemployment, arterial hypertension, and significant fibrosis remained independent predictors of an impaired HRQL. CONCLUSION: Metabolic comorbidities, significant fibrosis, and a lower socioeconomic status may negatively affect the HRQL in PLWH. Considering the negative impact of significant fibrosis on the outcome, counseling and preventive measures according to current guidelines are recommended in this subgroup of PLWH.

A cross-sectional study of patient-reported outcomes and symptom burden using PROMIS and PRO-CTCAE measures in light chain amyloidosis.

BACKGROUND: We conducted a cross-sectional study to characterize health-related quality of life and symptom burden in individuals living with light chain (AL) amyloidosis. METHODS: Members of the Amyloidosis Support Groups, Inc. with AL amyloidosis who consented to this IRB-approved survey provided information on their amyloidosis diagnosis, treatment, symptoms, and functioning. HRQL was measured using PROMIS and PRO-CTCAE questionnaires. RESULTS: Among 297 participants who responded, the median age at diagnosis was 60 years (23-82) with 52% female and 90% white race. There were 69% AL (lambda) and 39% reported 3 or more organs involved with amyloidosis (58% cardiac, 58% renal, 30% neurological AL). Time from diagnosis was less than 2 years in 64 (22%), 2-5 years in 105 (36%), > 5 years in 126 (43%), and unknown in 2 (< 1%) individuals. Therapy included prior chemotherapy in 88% and stem cell transplant in 52%. Fifty percent of the cohort was on active treatment. Multiple domains were impaired in AL amyloidosis compared to the general population, including physical function, fatigue, and social roles. While highest among those within 2 years of diagnosis, high symptom burden was also seen in long-term survivors. A trend to decreased severity and number of impaired symptoms was seen with longer treatment-free interval but many symptoms remained persistent. CONCLUSIONS: Significant and persistent symptom burden is seen in AL amyloidosis. Patient-reported outcomes should be routinely measured and used to provide best supportive care to all AL amyloidosis patients, including long-term survivors and those not on active therapy.

Long-term Patient-Centered Outcomes in Cirrhotic Patients With Chronic Hepatitis C After Achieving Sustained Virologic Response.

BACKGROUND & AIMS: Achieving sustained virologic response (SVR) among patients with hepatitis C virus (HCV) leads to patient reported outcome (PRO) improvement. We aimed to assess the long-term post-SVR PRO trends in HCV patients with cirrhosis. METHODS: Patients with HCV and cirrhosis treated in clinical trials with direct acting antiviral agents (DAAs) who achieved SVR-12 were prospectively enrolled in a long-term registry (clinicaltrials.gov #NCT02292706). PROs were collected every 24 weeks using the Short Form-36v2 (SF-36), CLDQ-HCV, and WPAI-HCV. RESULTS: Pre-treatment baseline data were available for 854 cirrhotic patients who achieved SVR after DAAs. Of these, 730 had compensated (CC) and 124 had decompensated cirrhosis (DCC) before treatment- patients with DCC reported severe impairment in their PROs in comparison to CC patients (by mean -5% to -16% of a PRO range size; p < .05 for 16 out of 20 studied PROs]. After achieving SVR and registry enrollment, significant PRO improvements were noted from pre-treatment levels in 11/20 domains for those with DCC (+4% to +21%) and 19/20 PRO domains in patients with CC (+3% to +17%). Patients with baseline DCC had higher rates of hepatocellular carcinoma and mortality (P < .05). In patients with CC, the PRO gains persisted up to 168 weeks (3.5 years) of registry follow-up. In patients with DCC, the improvements lasted for at least 96 weeks but a declining trend after year 2. CONCLUSIONS: Patients with HCV cirrhosis experience severe PRO impairment at baseline with sustainable improvement after SVR. Though those with DCC experience improvement, there is a decline after 2 years.

Can subjective symptoms predict objective findings in gastroesophageal reflux disease patients?

INTRODUCTION: Medical therapy is the first-line treatment for gastroesophageal reflux disease, but surgical options are available and shown to be effective when medical management fails. There is no consensus for when a surgical evaluation is indicated. We set out to determine if the GERD-HRQL questionnaire scores correlate to objective findings found in patients undergoing anti-reflux surgery to predict when surgical consultation could be warranted. METHODS: A prospectively gathered database was used for patients undergoing anti-reflux surgery from January 2014 to September 2020. Inclusion criteria required a diagnosis of GERD and comprehensive esophageal workup with the GERD-HRQL questionnaire, EGD, esophageal manometry, and ambulatory pH monitoring. Analysis of the GERD-HRQL scores was compared to objective endpoints to see correlation and predictability. Logistic regression analysis was used to assess relationship between the presence of objective findings and GERD-HRQL questionnaire scores. RESULTS: There were 246 patients meeting inclusion criteria. There was no significant correlation between GERD-HRQL score and DeMeester score (correlation coefficient = 0.23), or presence of a hiatal hernia, regardless of size (p = 0.89). Patients with esophagitis had significantly higher average GERD-HRQL scores compared to those without esophagitis (40.1 ± 18.9 vs 30.4 ± 19.1, p < 0.0001). Patients with a score of 40 or greater had a 42% to 65% probability of having esophagitis versus a score of 30 or less, lowering the chances of having esophagitis to less than 35%. CONCLUSION: Usage of a GERD-HRQL questionnaire score can potentially show the correlation between subjective and objective findings in the workup of a patient for anti-reflux surgery. Specifically, patients with a GERD-HRQL score of 40 or greater have an increased probability of esophagitis compared to those with a score of 30 or less. Using these scores can help referring clinicians identify those patients failing medical therapy and allow for prompt referral for surgical evaluation.

A novel EndoFLIP marker during hiatal hernia repair is associated with short-term postoperative dysphagia.

BACKGROUND: Endoluminal functional lumen imaging probe (EndoFLIP) provides an objective measure of the distensibility index (DI) during different parts of hiatal hernia repair. However, the absolute DI measure above a cut-off after creating a barrier alone has not shown a relationship to dysphagia after surgery. We wanted to determine if the change in DI with volume change is associated with dysphagia. METHODS: We included patients who had hiatal hernia repair with EndoFLIP values, including two values taken at the end of the surgical case with different volumes of fluid in the balloon (30 mL and 40 mL). We compared the absolute and change in DI during hiatal hernia repair and performed an analysis to determine if there was a correlation with short-term clinical outcomes. RESULTS: A total of 103 patients met the inclusion and exclusion criteria. Most of the patients underwent Toupet fundoplication (n = 56, 54%), followed by magnetic sphincter augmentation (LINX, n = 28, 27%) and Nissen fundoplication (n = 19, 18%). There was a significant reduction in the DI from the initial DI taken after mobilization of the hiatus (3 mm2/mmHg) and after the creation of the barrier (1.4 mm2/mmHg, p < 0.001). A minority of patients had a decrease or no change in the DI with an increase in balloon volume increased from 30 to 40 mL (n = 37, 36%). Overall, after 1 month, there was a significant decrease in the GERD-HRQL score from 23 to 4 (p < 0.001) and bloat score from 3 to 2 (p = 0.003) with a non-significant decrease in the dysphagia score from 1 to 0 (p = 0.11). Patients who had a decreased or unchanged DI with an increase in the balloon volume from 30 to 40 mL had a significant decrease in their dysphagia score by 2 points (p = 0.04). CONCLUSION: The decreased or unchanged DI with an increase in the balloon volume on EndoFLIP is associated with a significant reduction in dysphagia after surgery. The decrease in DI denotes the esophagus's ability to create higher pressure relative to the change in the cross-sectional area with a larger bolus across the gastroesophageal junction. This measure may be a new marker that can predict short-term outcomes in patients undergoing hiatal hernia repair.

The impact of care-recipient relationship type on health-related quality of life in community-dwelling older adults with dementia and their informal caregivers.

PURPOSE: To assess whether there was an association between care-recipient relationship type and health-related quality of life (HRQL) of older persons living with dementia (PLWD) and their informal caregivers, and whether this association was affected by PLWD' dementia severity. METHODS: This was a secondary data analysis study. PLWD (n = 1230) and caregivers (n = 1871) were identified from participants in the National Health and Aging Trends Study (NHATS) Round 5 and the National Study of Caregiving (NSOC) II, respectively. A series of bivariate and multivariable regression models examined the associations among relationship type and HRQL in PLWD and caregivers, adjusted for socio-demographic variables and dementia severity. RESULTS: PLWD and caregivers' HRQL outcomes varied by relationship type. PLWD cared for by an adult-child caregiver, or multiple caregivers experienced higher functional limitations than those cared for by a spousal caregiver (ß = .79, CI [.39, 1.19]; ß = .50, CI [.17, .82], respectively). "Other" caregivers, such as extended family members or friends, had lower odds of experiencing negative emotional burden and social strain than spousal caregivers (ß = .79, CI [.39, 1.19]; ß = .50, CI [.17, .82], respectively). Lower odds of experiencing negative emotional burden were also found with multiple caregivers. The effect of an adult-child caregiver on social strain was no longer significant when the dementia severity of PLWD was included in the analysis. CONCLUSION: The type of care-recipient relationship impacts the HRQL in both PLWD and their informal caregivers. Dementia severity of the PLWD appears to affect this association.

Health-related quality of life measures in adult spinal deformity: can we replace the SRS-22 with PROMIS?

PURPOSE: To determine the validity and responsiveness of PROMIS metrics versus the SRS-22r questionnaire in adult spinal deformity (ASD). METHODS: Surgical ASD patients undergoing ≥ 4 levels fused with complete baseline PROMIS and SRS-22r data were included. Internal consistency (Cronbach's alpha) and test-retest reliability [intraclass correlation coefficient (ICC)] were compared. Cronbach's alpha and ICC values ≥ 0.70 were predefined as satisfactory. Convergent validity was evaluated via Spearman's correlations. Responsiveness was assessed via paired samples t tests with Cohen's d to assess measure of effect (baseline to 3 months). RESULTS: One hundred and ten pts are included. Mean baseline SRS-22r score was 2.62 ± 0.67 (domains = Function: 2.6, Pain: 2.5, Self-image: 2.2, Mental Health: 3.0). Mean PROMIS domains = Physical Function (PF): 12.4, Pain Intensity (PI): 91.7, Pain Interference (Int): 55.9. Cronbach's alpha, and ICC were not satisfactory for any SRS-22 and PROMIS domains. PROMIS-Int reliability was low for all SRS-22 domains (0.037-0.225). Convergent validity demonstrated strong correlation via Spearman's rho between PROMIS-PI and overall SRS-22r (- 0.61), SRS-22 Function (- 0.781), and SRS-22 Pain (- 0.735). PROMIS-PF had strong correlation with SRS-22 Function (0.643), while PROMIS-Int had moderate correlation with SRS-22 Pain (- 0.507). Effect size via Cohen's d showed that PROMIS had superior responsiveness across all domains except for self-image. CONCLUSIONS: PROMIS is a valid measure compared to SRS-22r in terms of convergent validity, and has greater measure of effect in terms of responsiveness, but failed in reliability and internal consistency. Surgeons should consider the lack of reliability and internal consistency (despite validity and responsiveness) of the PROMIS to SRS-22r before replacing the traditional questionnaire with the computer-adaptive testing.

Minimally important differences for the EORTC QLQ-C30 in prostate cancer clinical trials.

BACKGROUND: The aim of the study was to estimate the minimally important difference (MID) for interpreting group-level change over time, both within a group and between groups, for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scores in patients with prostate cancer. METHODS: We used data from two published EORTC trials. Clinical anchors were selected by strength of correlations with QLQ-C30 scales. In addition, clinicians' input was obtained with regard to plausibility of the selected anchors. The mean change method was applied for interpreting change over time within a group of patients and linear regression models were fitted to estimate MIDs for between-group differences in change over time. Distribution-based estimates were also evaluated. RESULTS: Two clinical anchors were eligible for MID estimation; performance status and the CTCAE diarrhoea domain. MIDs were developed for 7 scales (physical functioning, role functioning, social functioning, pain, fatigue, global quality of life, diarrhoea) and varied by scale and direction (improvement vs deterioration). Within-group MIDs ranged from 4 to 14 points for improvement and - 13 to - 5 points for deterioration and MIDs for between-group differences in change scores ranged from 3 to 13 for improvement and - 10 to - 5 for deterioration. CONCLUSIONS: Our findings aid the meaningful interpretation of changes on a set of EORTC QLQ-C30 scale scores over time, both within and between groups, and for performing more accurate sample size calculations for clinical trials in prostate cancer.

Social distancing during the COVID-19 pandemic and health-related quality of life among esophageal cancer survivors.

PURPOSE: The purpose was to investigate whether social distancing during the COVID-19 pandemic reduced health-related quality of life (HRQL) in esophageal cancer patients and if so, to identify factors related to the HRQL changes. METHODS: A prospective Swedish nationwide study of patients who undergone surgery for esophageal cancer between 2013 and 2019. Telephone interviews were conducted 5 weeks and 13 weeks after the introduction of social distancing recommendations. The participants responded to a few scales and items from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30. Regression models adjusted for potential confounders were used to examine mean score differences (MSD) with 95% confidence intervals (CI) between compliance with the recommendations and HRQL. RESULTS: In total, 134 individuals participated in the study. At 5 weeks, a reduction in role function was seen for individuals who fully (MSD -8, 95% CI: -16 to 0) and to a large extent (MSD -19, 95% CI: -26 to -12) complied with the recommendations. Less fatigue (MSD 9, 95% CI: 3-15) was also detected for this group. Being female, elderly, having comorbidities, living in a region with higher COVID-19 incidence, living in a villa, and being considered as an at-risk person were related to changes in role function. At 13 weeks, reductions in role function continued for those who fully complied with the recommendations (MSD -10, 95% CI: -19 to -1), but the risk variables were of less importance. Improvements in fatigue were no longer detected. Global quality of life, emotional function, or insomnia remained stable over time. CONCLUSIONS: This study indicates that individuals who undergone surgery for esophageal cancer and fully or to a large extent complied with the recommendations experienced reductions in role function, but not in global quality of life or emotional function, during the COVID-19 pandemic.

Laparoscopic fundoplication for refractory GERD: a procedure worth repeating if needed.

BACKGROUND: Laparoscopic fundoplication is the current gold standard for medically refractory gastroesophageal reflux disease. Over a 10-year period following surgery, 5-10% of primary laparoscopic fundoplication patients undergo reoperative surgery. Our objective was to compare the symptomatic outcomes and morbidity of primary and reoperative fundoplication procedures. METHODS: This was a retrospective review of patients who underwent laparoscopic primary or reoperative fundoplication between 2011 and 2017. A single surgeon with a more than 10-year experience in reoperative foregut surgery performed all procedures. Patients in both groups completed the GERD health-related quality of life (GERD-HRQL) survey prior to surgery and postoperatively. Outcomes were reflected by the composite GERD-HRQL scores (0 to 50, with lower scores representing a better GERD-related quality of life), which were compared between groups postoperatively. Demographics, perioperative data, and complications were compared. Patient data were analyzed using Chi-Square tests and outcomes were analyzed using independent samples t tests and Mann-Whitney U tests. RESULTS: There were 136 primary and 82 reoperative fundoplications. Prior to surgery, GERD-HRQL scores were similar for primary and reoperative patients. Both groups experienced significant improvement in GERD-related quality of life at 2 years, although this improvement was greater in primary patients (8.7 ± 7.8 primary vs. 14.3 ± 13.6 reoperative, p = 0.02). Operative time and length of stay were longer following reoperative cases. The rate of moderate to severe 30-day complications requiring radiologic, endoscopic, or surgical intervention was similar (2.9% primary vs. 1.2% reoperative, p = 0.65). CONCLUSIONS: Patients who undergo reoperative fundoplication experience a significant improvement in their GERD-related symptoms, although not to the degree seen in primary antireflux surgery patients. Perioperative morbidity rates following reoperative and primary procedures can be similar in the hands of an experienced surgeon.

Does antrum size matter in sleeve gastrectomy? A prospective randomized study.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) is a safe and effective bariatric procedure in terms of excess weight loss. Nevertheless, controversies still exist on several technical and operative aspects of LSG. The aim of this study is to evaluate variations in anthropometric features in subjects with a LSG gastric resection starting from 2 cm or 6 cm from the pylorus. Secondary aim was the evaluation of differences in morbidity, food tolerance, and GERD incidence studied with upper endoscopy (UE) and GERD Health-Related Quality-of-Life score. METHODS: Patients were prospectively randomized into 2 groups: Group A (at 2 cm proximally to the pylorus) and Group B (at 6 cm proximally to the pylorus). All patients were followed-up at 3, 6, 12, and 24 months. UE was performed in all patients at 12 or 24 months. RESULTS: One hundred and fifty met the inclusion criteria and were enrolled in the study. The anthropometric features (BMI, %EWL, %TWL) resulted statistically different in the first 12 months (24.2 ± 3.4 vs 27.5 ± 4.3, 63.7 ± 14.1 vs 59.6 ± 12.5 and 42.9 ± 7.4 vs 38.2 ± 6.2), in favor of group A. At 24 months the differences disappeared (25.2 ± 4.4 vs 26.2 ± 3.3, 62.8 ± 13.1 vs 61.6 ± 10.5 and 41.9 ± 7.4 vs 40.2 ± 6.2). An increased GERD was found in both groups postoperatively with a higher incidence in group A at 6-month follow-up. CONCLUSION: Performing the LSG with a radical antrectomy could improve weight loss at 12-month follow-up but expose to lower food tolerance and higher transitory GERD. The differences seem to be reduced to a 24-month.

Short-term outcome of routine use of EndoFLIP during hiatal hernia repair.

BACKGROUND: Endoluminal functional lumen imaging probe (EndoFLIP) technology is a tool that can be used to provide intraoperative objective real-time feedback during hiatal hernia repair. We wanted to determine the implication of initial distensibility index (DI) after mobilization of hiatus and final DI after creation of barrier in short-term clinical outcomes. METHODS: We performed a retrospective analysis of prospectively collected data on the intraoperative use of EndoFLIP during hiatal hernia repair at a single institution from 2017 to 2019. We analyzed the initial DI and final DI with the short-term clinical outcomes. RESULTS: There were 163 patients who had Nissen (n = 16), Toupet (n = 79) or magnetic sphincter augmentation (n = 68) with (n = 158) or without (n = 5) hiatal hernia repair with median initial DI was 3.2 mm2/mmHg. We used 3 mm2/mmHg as the cutoff for low (n = 84) vs. high (n = 79) initial DI group. There was no difference in DeMeester score (p = 0.76), the peristalsis on manometry (p = 0.13), type of hiatal hernia (p = 0.98), and GERD-HRQL score prior to surgery (p = 0.73) between the groups. There was significantly higher final DI in the high initial DI group compared to low initial DI group; however, there was no significant difference in the GERD-HRQL score at 1-3 months (p = 0.28). All of the patients had a final DI > 0.5 mm2/mmHg at the end of the case with median final DI of 1.6 mm2/mmHg. None of these patients required steroids (0%) and only one patient (0.6%) required EGD and dilatation as well as re-operation for dysphagia within 3 months. CONCLUSIONS: The initial DI was associated with final DI, but it did not correlate with improvement in short-term GERD-HRQL score. Final DI maintained above the cutoff value led to most of the patients not to require intervention for dysphagia. Use of the EndoFLIP can provide objective data during the operation and prevent severe dysphagia after repair.

The patient journey to diagnosis and treatment of congenital sucrase-isomaltase deficiency.

PURPOSE: Congenital sucrase-isomaltase deficiency (CSID) is a rare genetic disorder characterized by a deficiency of the sucrase-isomaltase (SI) enzyme complex within the brush border membrane of the small intestine. Mutations in the SI gene result in abnormal synthesis and/or incorrect transport of the SI enzyme. Patients with CSID generally have reduced sucrase activity, but levels of isomaltase activity range from absent to almost normal. This study sought to better understand the experience of patients with CSID prior to, during, and after their diagnosis and its subsequent treatment with sacrosidase. METHODS: This was a cross-sectional interview study conducted in conjunction with a longitudinal, observational study of US patients prescribed and taking sacrosidase for at least three consecutive months as treatment for CSID. The observational study included both children and adults. RESULTS: This qualitative interview study explored the experiences of 43 adult and pediatric patients (n = 8 adults and n = 35 children/adolescents) with CSID pre-, during, and post-diagnosis. Findings suggest that a CSID diagnosis is particularly problematic given the disparate range of more commonly understood gastrointestinal (GI) disorders. After diagnosis and treatment with sacrosidase, participants reported considerable improvement in symptoms and health-related quality of life (HRQL), yet symptoms persist that continue to affect daily life, indicating areas of potential unmet need. CONCLUSION: Educating clinicians about CSID may help improve the overall diagnosis experience. As this research is the first of its kind in CSID, additional research, qualitative and quantitative, will be important to furthering the understanding of HRQL impact and unmet need experienced by this population and identifying ways to best meet those needs.

Health-related quality of life in patients with autoimmune hepatitis.

BACKGROUND: Autoimmune hepatitis (AIH) is a rare chronic liver disease. Impaired health-related quality of life (HRQL) contributes to the overall disease burden. At current, only limited data related to the impact of treatment response on HRQL are available. OBJECTIVE: The aim of the study was to determine the impact of biochemical remission on HRQL. METHODS: Patients with AIH were prospectively enrolled between July 2018 and June 2019. A liver disease-specific tool, the chronic liver disease questionnaire (CLDQ) and the generic EQ-5D-5L were used to quantify HRQL. Treatment response was assessed biochemically by measurement of immunoglobulin G, ALT and AST. The cohort was divided into two groups according to their biochemical remission status in either complete vs. incomplete remission. Clinical as well as laboratory parameters and comorbidities were analysed using univariable and multivariable analysis to identify predictors of poor HRQL. RESULTS: A total of 116 AIH patients were included (median age: 55; 77.6% female), of which 9.5% had liver cirrhosis. In this cohort, 38 (38.4%) showed a complete and 61 (61.6%) an incomplete biochemical remission at study entry. The HRQL was significantly higher in patients with a complete as compared to an incomplete biochemical remission (CLDQ overall score: 5.66 ± 1.15 vs. 5.10 ± 1.35; p = 0.03). In contrast, the generic EQ-5D-5L UI-value was not different between the groups. Multivariable analysis identified AST (p = 0.02) and an incomplete biochemical remission (p = 0.04) as independent predictors of reduced HRQL (CLDQ total value). CONCLUSION: Patients with a complete biochemical remission had a significantly higher HRQL. Liver-related quality of life in patients living with AIH is dependent on the response to immunosuppressive treatment.