Generic Health-related Quality Of Life Research Articles

Impact of treatment of hyperkalaemia on quality of life: design of a prospective observational cohort study of long-term management of hyperkalaemia in patients with chronic kidney disease or chronic heart failure in Japan

IntroductionHyperkalaemia (HK) is a frequent complication in patients with chronic kidney disease (CKD) and/or chronic heart failure (CHF). HK must be managed, both to protect patients from its direct clinical...

The HAIR-QoL measure Part 1: What are the quality of life issues for people with cancer with chemotherapy-induced alopecia?

This paper describes the development of the provisional HAIR-QoL questionnaire on the impact of chemotherapy-induced alopecia on health-related quality of life. A total of 43 items have been developed. IntroductionChemotherapy Induced Alopecia (CIA) is the most visible side effect of chemotherapy treatment, carrying an important psychosocial burden, and negatively affecting health-related quality of life (HRQoL). No internationally validated instrument for the severity and impact of CIA exists for people with cancer for both sexes, which has hindered research in this area. Therefore, our aim was to develop a patient-reported measure for use in research and patient care. MethodsWe established a list of potential issues based on experiences of patients and healthcare professionals (HCPs) through a literature review, interviews, and focus groups with 52 patients in various cancer centres from three countries. Thereafter, a total of 51 eligible patients and 11 HCPs from four countries scored these issues on relevance and priority before translating into items for the provisional HAIR-QoL questionnaire. ResultsThe literature search identified 293 issues, and focus groups and interviews another 618 issues. Removing duplicates and general HRQoL issues resulted in 95 pertinent issues across 6 health-related QoL domains: (1) meaning and importance of hair, (2) satisfaction with the received information regarding hair loss and preparedness, (3) impact of hair loss on self, (4) impact of hair loss on others, (5) management of changes/side effects, and (6) regrowth of hair. Differences in relevance scores could be detected between males and females, and were associated with 5 items on the wearing of a wig/head cover (Z = 2.9–3.4, p between 0.001 and 0.004). Also relevance scores for ‘wearing a wig/head cover for my partner/children’ were higher for female patients with breast cancer compared to other cancers (Z = 3.2, p = 0.001). The calculated scores on relevance and priority led to a total of 43 issues that have been translated into items. ConclusionThis study shows that people with cancer with CIA experience important HRQoL issues, not adequately measured by existing HRQoL measures. CIA can affect male people with cancer as much as it can affect females. The provisional HAIR-QoL questionnaire provides an optimal approach for multidisciplinary teams who care for people with cancer in understanding their patients’ concerns and priorities around CIA.

Translation and Validation Testing of the Constipation-Related Quality of Life Scale for Use in Japan.

Introduction Establishing a scale that can easily be used to appropriately measure the impact of constipation on the quality of life in Japan is a first step toward addressing this important health issue. We developed a Japanese language version of the Constipation-Related Quality of Life scale, which has 18 items and four subscales, and then subjected it to validation testing. Methods After translation according to a standardized and commonly used procedure, the Japanese version of the Constipation-Related Quality of Life scale was administered to people in an internet-based panel, in March 2023. The participants included 1,276 adults who had constipation (median age: 60 years, 690 {54.1%} males). The outcome measures included the Constipation-Related Quality of Life scale, the Constipation Scoring System (an index of constipation severity), and the Medical Outcomes Study (MOS) eight-item short form (a measure of generic health-related quality of life). Results Confirmatory factor analysis (four-factor model) indicated that all 18 Constipation-Related Quality of Life items had sufficiently high factor loadings (0.686-0.926). Internal consistency reliability was high (Cronbach's alpha: 0.86-0.94). Scores on the social impairment subscale and on the distress subscale of the Constipation-Related Quality of Life scale were significantly worse in the participants who had worse scores on the social functioning and mental health domains, respectively, of the MOS eight-item short form, which indicates good concurrent validity. Regarding criterion-based validity, the four subscale scores differed significantly among the four constipation-severity groups. The four subscale scores were also 1.16-4.53 times more sensitive than the MOS eight-item short form's mental component score to differences among the four constipation-severity groups (relative validity: 1.16-4.53), which indicates good discriminant validity. Conclusion The Japanese version of the Constipation-Related Quality of Life scale can be used with confidence in its factor structure, its concurrent, criterion-based, and discriminant validity, and its internal consistency reliability.

QOL-17. SLEEP QUALITY DIMENSIONS IN LOW AND HIGH-GRADE GLIOMA SURVIVORS

Abstract In this study, we examined the relationship between sleep disturbance and tumor grades in a group of low-grade (LGG; grade I-II) and high-grade glioma (HGG; grade III-IV) survivors < 1 to 10+ years from initial diagnosis. 42 glioma survivors completed the Pittsburgh Sleep Quality Index (PSQI). We examined frequency of poor sleep quality (defined as PSQI >5) and compared global PSQI between LGG and HGG groups. We obtained high-resolution T1 weighted images from a subset of 24 patients for gray matter volume analyses. The sample was predominantly male (66%) and Caucasian (82%). Of the 42 participants, 31% (n = 13) had LGG and 69% (n = 29) had HGG. 60% (n = 25) of all participants had poor sleep quality, with no differences observed between LGG and HGG. There were no differences between groups in age, education, measures of depression and anxiety, or general health-related quality of life (MOS SF-36). A Mann-Whitney U test indicated that there was no significant difference in global PSQI scores between LGG (Mdn = 4) and HGG groups (Mdn = 6), U = 239, p = .254. Sleep quality was not associated with time since diagnosis for either LGG (r = .108, p = .724) and HGG groups (r=-.058, p = .762). Whole brain vertex-wise comparison revealed smaller gray matter volumes in patients with poor sleep quality versus good sleep quality in the isthmus cingulate, cuneus, and precuneus of the left hemisphere (p < 0.05). Our analyses suggest that sleep quality is important to assess in glioma survivors of any grade and at any time since diagnosis. Poor sleep in glioma survivorship could be associated with structural differences in brain regions sensitive to sleep problems in other populations. Given the high rate of sleep disturbance, further study is warranted to better understand risk and develop targeted interventions.

Abstract 15211: Age and Improvement in Health- Related Quality of Life After Percutaneous Coronary Intervention

Background: The purpose of percutaneous coronary intervention (PCI) is to relieve chest pain, improve health-related quality of life (HRQoL), or reduce the risk of cardiac adverse events and death among patients with coronary artery disease. The aim of this study was to investigate whether age is related to HRQoL improvement in patients undergoing PCI and which clinical characteristics explain the changes in HRQoL during 12 months. Methods: Altogether 301 patients undergoing PCI were divided into three age groups: ≤65 (n=94), 66-74 (n=117), and ≥75 (n=90). Patients responded to the generic 15D and disease-specific SAQ-7 HRQoL instruments at baseline and 1 and 12 months after PCI. Results: The median ages in groups were 60, 69, and 79 years, and the proportions of women were 19.1%, 32.5%, and 35.6%, respectively. Baseline instrument scores were lower in the oldest group compared to the youngest groups (15D p <0.001, SAQ-7 p =0.006). 15D and SAQ-7 improved statistically ( p <0.001 for all) and clinically significantly in all groups at 1 month. At 12 months, the 15D score decreased in all groups but remained statistically and clinically higher compared to baseline in the two youngest groups, and in the oldest group, it was statistically ( p =0.005) and nearly clinically higher (threshold 0.015, Δ score 0.013, 95% CI -0.003-0.030). In the oldest group, deterioration in the 15D between 1 and 12 months was due to dimensions “mobility”, “vision”, and “excretion” but not in “cardiac-related” dimensions. Significant improvement in SAQ-7 score at one-year follow-up was observed in all groups ( p <0.001 for all). The improvements in 15D and SAQ-7 scores at 12 months showed no difference between the age groups ( p =0.381). Conclusions: There was no difference in the improvement of generic or disease-specific HRQoL after PCI between the age groups. Importantly, both 15D and SAQ-7 improved equally in the oldest groups as in the younger patients.

Health-related quality of life assessment instruments for extracorporeal membrane oxygenation survivors: A scoping review.

Extracorporeal membrane oxygenation (ECMO) has been successfully and widely used in adult patients for the past 5years. About 50% of these patients can survive and are discharged from hospitals. Health-related quality of life (HRQOL) is crucial for evaluating survived ECMO patients. This scoping review aims to identify instruments commonly used to measure HRQOL of ECMO survivors and give pertinent instrument characteristics. A systematic search was conducted in PubMed, Web of Science, EMBASE (OVID), MEDLINE (OVID), CINAHL (EBSCO), Cochrane Library, and three Chinese databases from January 2012 to December 2021. Two reviewers independently reviewed publication selection and data extraction. Twenty-nine studies met the inclusion criteria. Most studies (93%) were cross-sectional, and the median (or average) follow-up time ranged from 3months to 9years. Two prospective studies (7%) followed patients longitudinally until 1year after discharge. ECMO survivors had poorer long-term HRQOL than the general population. However, it is comparable to or better than patients with other critical or chronic illnesses. Identified HRQOL assessment instruments show four generic HRQOL instruments, one disease-specific HRQOL instrument, and nineteen single-dimensional instruments. Seven instruments were used in more than three articles. SF-36 (86.2%), IES/IES-R (41.4%), and HADS (37.9%) were the most frequently used instruments. The timing, frequency, and tools for HRQOL assessment of ECMO survivors are variable. No ECMO-specific HRQOL instrument was developed and validated. Further studies on assessment instruments are warranted. Research is also needed to identify interventions that may enhance HRQOL in ECMO survivors.

Think Before You Ink: Perception, Prevalence, and Correlates of Tattooing and Tattoo Regret in US Adults.

Introduction Few population-based studies have examined the perception and prevalence of tattoos and tattoo regret in the general United States (US) adult population. Our objective was to report the perception of people with tattoos and describe the prevalence, socio-demographics, health-related quality of life, and the extent of tattoo regret in US adults. Methods Data were assessed from a cross-sectional study of US adults. Participants were recruited using a random stratified sampling framework similar to the US Census. Data collected for all participants included socio-demographic and clinical characteristics, general health-related quality of life (Veterans RAND 12-item), depression (Patient Health Questionnaire 9-item), anxiety (Generalized Anxiety Disorder 7-item), and perceptions of those with tattoos. Those with tattoos also answered questions about their tattoo(s), including age when first tattooed, reasons for getting a tattoo, and tattoo regret. Categorical data were described by percentages, and continuous data by mean and standard deviation. Proportions were compared with Chi-squared testsand the means with ANOVA. A logistic regression controlling for confounding variables was carried out to assess factors predictive of tattoo regret. Results Of the 3033 participants, 35.3% (1,072) reported having a tattoo. Those more likely to have a tattoo were female (58% vs. 45%), younger (38 vs. 46 years), smoked cigarettes (38% vs. 19% non-smoker), and/or reported analcohol or drug problem (10% vs. 5%). Those without tattoos were more likely to perceive those with tattoos as less attractive, intelligent, professional, and more rebellious. More time (in years) with a tattoo, having a tattoo on the face, neck, hands, wrist, or fingers, getting a tattoo because of peer pressure, being impaired when getting a tattoo, and experiencing an adverse event related to a tattoo were predictive of tattoo regret. Older age and remembrance as the reason for a tattoo were predictive of not having tattoo regret. Conclusion More than one-third of the studysample comprised of adults in the US reported having at least one tattoo. While most people, regardless of their tattoo status, perceived tattooed and non-tattooed individuals equally, tattooed individuals were more likely to be perceived negatively than positively by those without tattoos. Whether tattooed or not, being aware of varying perceptions of tattoo status may be helpful in facilitating positive outcomes.

Health-Related Quality of Life (HRQoL) in Patients with Genetic Standard and High-Risk Disease at Trial Entry: A Cross-Sectional Analysis of RADAR (UK-MRA Myeloma XV)

Introduction Clinical outcomes in newly diagnosed multiple myeloma (MM) are independently influenced by genetic risk as determined by FISH and molecular profiling. However, little is known about the impact of these characteristics on HRQoL of MM patients at diagnosis, and if this is independent of other diagnostic criteria such as International Staging System (ISS) and CRAB. Similarly, there is little quantitative information on HRQoL of MM patients in contrast to other cancer patients and healthy individuals. We examined patient-reported outcomes from participants enrolling in the RADAR study to understand the HRQoL of MM patients in different subgroups prior to treatment. Methods The RADAR study (Eudract: 2019-001258-25) is a national, multi-centre, risk-adapted, response-guided multi-arm, multi-stage phase II/III trial for newly diagnosed MM eligible for ASCT. RADAR treats patients with induction, consolidation and maintenance options using combinations of lenalidomide, cyclophosphamide, bortezomib, dexamethasone and isatuximab. Genetic risk was defined using centrally reviewed standard-of-care NHS testing and participants enter the standard or high-risk pathway based on the presence of at least two of the markers: t(4;14), t(14;16), t(14:20), del(17p), gain(1q) and del(1p). CRAB diagnostic criteria at baseline were defined as hypercalcaemia (>2.6 mmol/l), renal impairment as indicated by eGFR by MDRD (30-60, >60 mL/min/1.73m 2), anaemia (Hb<100g/L) and the number of lytic lesions at trial entry (0, >=1). HRQoL was measured by EORTC QLQ-C30 and MY20 completed at trial entry. We used one-way ANOVA and two-sample unequal variance t-tests to compare subscales in standard and high-risk groups and CRAB criteria groups. We sought minimally important differences that were at least medium by accepted definitions, and adjusted p-values using the Bonferonni correction for the 19 subscales (adjusted P = 0.05/19 = 0.0026). We undertook similar comparisons with normative scores (NORM) for cancer patients and UK healthy controls. Results Baseline HR-QoL was available for 301 participants enrolled in RADAR. Median age at trial entry was 61 (range, 34-74), 165 (57.5%) were male and 249 (88.3%) ECOG PS0-1. 235 (78.1%) patients were classified as standard risk and 52 (21.9%) as high-risk. 111 (38.7%) patients were ISS1, 116 (40.4%) were ISS1 and 50 (17.4%) were ISS3. 24 (8.6%) patients had hypercalcaemia, 48 (16.7%) patients had eGFR < 60 mL/min/1.73m 2, 67 patients (23.8%) had anaemia and 287 (65.9%) patients had at least one bone lesion. Comparing standard and high-risk genetics patients, there were no significant differences in any C30 or MY20 subscales (Figure A). Increasing ISS was significantly associated with worse Physical and Role Functioning, increased Fatigue and Dyspnoea. Renal impairment (eGFR< 60 mL/min/1.73m 2) was not associated with differences in any C30 or MY20 subscales. Anaemia was significantly associated with worse Global health status/QoL, Physical Functioning and Role Functioning, and Fatigue was significantly increased. The presence of bone lesions was significantly associated with worse Global health status/QoL, Physical Functioning, Role Functioning and Social Functioning, and Fatigue, Pain, Disease Symptoms, Side Effects and Body Image worries were significantly increased (Figure B). Comparing RADAR to the C30 Cancer NORM, 7 of 15 subscales were significantly worse. Small negative differences were observed for Physical and Role Functioning, Fatigue, Insomnia and Constipation and medium negative differences were observed for Social Functioning and Pain. Similarly, in contrast to UK C30 Healthy NORM, 8 of 15 subscales were significantly different. There were small detrimental differences observed for Physical Functioning, Role Functioning, Appetite Loss, Constipation and Financial Problems, medium differences for Fatigue and Pain and large differences for Social Functioning. Conclusion Prior to commencing treatment, patients with genetic high-risk MM did not have significantly different HRQoL to standard risk MM whereas ISS, an established measure of disease burden, did impact HRQoL. Similarly, CRAB criteria of anaemia and bone disease significantly impact several HRQoL domains. Compared to the general Cancer and UK healthy population HRQoL in patients entering RADAR was significantly worse in some subscales, notably Pain and Fatigue.

Antibiotics for otitis media with effusion (OME) in children.

Antibiotics for otitis media with effusion (OME) in children.

Health-Related Quality of Life Outcome Measures in Individuals With Hereditary Hemorrhagic Telangiectasia: A Scoping Review.

Studies evaluating health-related quality of life (HRQOL) in patients with hereditary hemorrhagic telangiectasia (HHT) have expanded rapidly in the past decade. These studies have evaluated QOL aspects ranging from the general QOL for patients living with HHT to intervention-specific outcomes. However, few tools have been fully validated across the spectrum of disease manifestations and interventions in HHT. In this scoping review, we aim to map the literature on HHT-QOL metrics, identify gaps, inform future QOL research, and facilitate future metric development. We analyzed articles in English that assessed at least 1 measure of general HRQOL, including physical health, mental health, social health, or intervention-specific QOL in patients with HHT. Searches across 2 bibliographic databases (PubMed and Scopus) yielded 186 articles after duplicates were removed. Sixty-three studies met eligibility criteria: 22 prospective studies (34.9%), 20 retrospective studies (31.7%), 12 cross-sectional studies (17.5%), 6 randomized controlled trials or secondary analyses of a randomized controlled trials (9.5%), 2 qualitative studies (3.2%), and 1 case-control study (1.6%). Two additional studies-1 prospective and 1 cross-sectional study-were identified at the October 2022 14th International HHT Conference and included, making a total of 65 studies. The 65 eligible studies used 30 QOL instruments. Twenty studies characterized baseline HRQOL, and 45 studies evaluated QOL before and after treatment. Of those 45 studies, 37 evaluated HRQOL before and after therapies targeting epistaxis and nasal symptoms, 4 targeted therapies for liver arteriovenous malformations and high-output heart failure, 3 evaluated therapies for both epistaxis and gastrointestinal bleeding, and 1 evaluated treatment targeting gastrointestinal bleeding alone. Comparison of results across studies remains challenging given the heterogeneity in outcomes measures. Further development of HHT-specific patient-reported outcomes instruments that capture the global illness experience of HHT is needed.

Lifestyle Behaviors and Health-Related Quality of Life in Cancer Survivors: A Latent Class Analysis.

Healthy lifestyle behaviors can improve health-related quality of life (HRQOL) in cancer survivors; but the combination of behaviors most important for HRQOL is not known. This study investigated the patterns of lifestyle behaviors among cancer survivors and differences in HRQOL between behavioral classes. Cancer survivors (n = 2,463) were invited to participate in a cross-sectional survey. Participants (N = 591) were predominately female (63%) and non-Hispanic White (90%). Survey items included self-reported physical activity, diet, smoking, sleep, HRQOL, and demographics. Behavioral classes were estimated by latent class analysis. Differences between classes were assessed by latent class regression. Compared with the "healthy lifestyles" class (higher probabilities of meeting aerobic/strength-based activity guidelines, high fruit/vegetable intake, and no sleep problems; 11% of sample), the "sleep and diet problems with inconsistent physical activity" class (higher probabilities of not meeting strength-based guidelines, low fruit/vegetable intake, some sleep problems; marginally higher probability of meeting aerobic guidelines; 41%) had poorer general and physical HRQOL. The "poor physical activity and diet" class (higher probabilities of not meeting aerobic/strength-based guidelines, low fruit/vegetable intake, and some sleep problems; 48%) had poorer general, physical, and mental HRQOL. Few participants exhibited healthy lifestyle patterns associated with HRQOL. The findings provide opportunities to develop differentiated multiple behavior-change interventions, targeted to two common patterns of behavior. A large subgroup of cancer survivors was susceptible to suboptimal physical activity and diet, warranting interventions exclusively targeting these behaviors. Another subgroup was susceptible to suboptimal physical activity, diet, and sleep, indicating interventions for this group should include strategies targeting these three behaviors.

Comparison of Tympanostomy Tubes Under Local Anesthesia Versus General Anesthesia for Children.

Tympanostomy tube insertion (TTI) is typically accomplished under general anesthesia (GA) in the operating room. We aimed to compare pain between GA and local anesthesia (LA) in surgically naïve children undergoing TTI. Secondary objectives examined patient's quality of life (QoL) and parent's satisfaction. Prospective single-center study. Tertiary pediatric academic center. Consecutive children who underwent TTI under GA were compared to patients under LA. Pain standardized observational pain scales (Face, Legs, Activity, Cry, Consolability Scale [FLACC], Children's hospital of Eastern Ontario Pain Scale [CHEOPS]) were completed pre-procedure, during the first tympanostomy and second tympanostomy, and post-procedure, as well as 1 week postoperatively. General health-related QoL (PedsQL) and QoL specific to otitis media (OM-6) were measured before insertion and 1 month postoperatively. Parental satisfaction was also evaluated using a qualitative scale. LA group had statistically significant higher pain levels at the beginning (7.3 vs. 0), during the first tympanostomy (7.8 vs. 0), during the second tympanostomy (7.7 vs. 0), and at end of the procedure (6.9 vs. 0) with the FLACC scale (all p < 0.01). Results were similar with the CHEOPS scale. No pain was noted 1 week after surgery in either group. Both groups had similar improvement in their QoL (p > 0.05). Minor complication occurred at a similar rate (p > 0.05). Parents were equally satisfied with their choice of anesthesia in both groups when initially questioned after the procedure (p > 0.05). Children experienced significantly less pain under GA than LA. If LA is to be used, pain and distress-reducing strategies are critical. Shared decision-making with families is essential. 3 Laryngoscope, 134:2422-2429, 2024.

Arabic translation, cross cultural adaptation, and validation of Foot Health Status Questionnaire among Saudi individuals with plantar fasciitis

BackgroundMeasuring quality of life (QoL) plays an essential role in enabling meaningful cross-cultural comparisons. The Foot Health Status Questionnaire (FHSQ) is a valid tool for assessing both foot-specific and general health-related quality of life (HrQoL), making it suitable for evaluating Plantar Fasciitis (PF) patients.MethodologyThe aim of this study is to translate the FHSQ into Arabic following methodological assessments of the translation procedure. The translation was done using forward and back translation. A pre-test questionnaire was distributed among 50 patients, resulting in the final FHSQ-Ar version, which then underwent various psychometric evaluations among 87 persons with PF, including internal consistency, dimensionality, reliability, interpretability, and construct validity against the 100-mm Visual Analogue Scale (VAS).ResultsInternal consistency was adequate, ranging from 0.70 to 0.92. Reliability values ranged from 0.69 to 0.80, with a poor standard error of measurement (individual) but an acceptable standard error of measurement (group). Two domains exhibited floor effects, while one domain showed a ceiling effect. Regarding validity, three out of four hypothesized correlations with VAS scores were confirmed. Factor analysis revealed four dimensions, and confirmatory factor analysis demonstrated good fit (comparative fit index = 0.98, standardized root mean square = 0.06).ConclusionThe psychometric properties of the FHSQ-Ar were satisfactory. Further validation for other diseases may be warranted.

Evaluation of the health-related quality of life and associated factors in Zimbabwean adults living with HIV: a cross-sectional study

ObjectiveHIV remains a global burden, with the Sub-Saharan Africa (SSA) region reporting the largest number of people living with HIV/AIDS (PLHIV). An exponential improvement in the accessibility and uptake of antiretroviral treatment across SSA has significantly improved outcomes for PLHIV. Hence, HIV care goals have shifted from reducing mortality and morbidity to improving health-related quality of life (HRQoL). This study uses generic and condition-specific HRQoL outcomes to holistically determine the HRQoL of Zimbabwean adult PLHIV and associated factors. HRQoL is a dynamic subject construct that warrants continuous evaluation to provide meaningful feedback to various stakeholders. We enrolled 536 adult PLHIV in Zimbabwe. Collected data were analyzed through descriptive statistics and multivariate binary logistic regression.ResultsOur study shows a high HRQoL perception by Zimbabwean PLHIV. Anxiety, depression, and poor environmental health were widely reported domains influencing HRQoL. Also, being aware of HIV status for over a year, not experiencing an adverse event, being married, having adequate finances and food security and having higher educational status were associated with higher HRQoL. It is essential to integrate mental health care into routine HIV care to improve treatment outcomes and HRQoL. Last, implementing bespoke multisectoral HRQoL-enhancement interventions is paramount.

Health-related quality of life and its determinants during and after treatment for paediatric acute lymphoblastic leukaemia: a national, prospective, longitudinal study in the Netherlands

ObjectivesHealth-related quality of life (HRQoL) is impaired in paediatric patients with acute lymphoblastic leukaemia (ALL). Over the past decades, ALL treatment has successfully been adjusted to the risk of relapse,...

Real-World Effectiveness, Safety, and Health-Related Quality of Life in Patients Receiving Adjuvant Nivolumab for Melanoma in Belgium and Luxembourg: Results of PRESERV MEL.

Nivolumab, an anti-programmed cell death 1 immuno-oncology therapy, is approved as an adjuvant treatment for patients with completely resected stage III or stage IV melanoma. PRESERV MEL (Prospective and REtrospective Study of nivolumab thERapy in adjuVant MELanoma) is a real-world observational study evaluating the effectiveness and safety of adjuvant nivolumab in patients with completely resected stage III or stage IV melanoma in clinical practice in Belgium and Luxembourg. Patients were enrolled prospectively and retrospectively during a 2-year period (January 2019-January 2021), and will be followed for 5 years. The results reported here are for the second interim analysis (cutoff date 31 December 2021). The index date was the date of first administration of adjuvant nivolumab. Patients received nivolumab for up to 12 months per label. Outcomes included relapse-free survival (RFS), adverse events (AEs)/treatment-related AEs (TRAEs), and health-related quality of life (HRQoL; assessed in prospectively enrolled patients using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), Functional Assessment of Cancer Therapy-Melanoma (FACT-M), and EQ-5D-3L instruments). HRQoL was evaluated at group level (mean change in scores from baseline based on minimally important differences) and individual patient level (percentage of patients with clinically important scores based on threshold of clinical importance). Outcomes were analyzed descriptively. The study enrolled 152 patients (125 prospective, 27 retrospective) at 15 hospitals in Belgium and Luxembourg. Minimum potential follow-up at time of analysis was 11.4 months. Median age was 60 years (range 29-85), and 53% of patients were male. At 12 and 18 months, the RFS rates were 74.7% (95% confidence interval (CI): 66.9-80.9) and 68.4% (95% CI: 60.0-75.5), respectively. Median RFS was not reached. Grade 3 or 4 TRAEs were reported in 14% of patients. AEs led to treatment discontinuation in 23% of patients. Deaths occurred in 3% of patients and were not related to treatment. Questionnaire completion rates for HRQoL were high at baseline (90-94%) and at 24 months (78-81%). In the group-level analysis for HRQoL, mean changes in scores from baseline remained stable and did not exceed prespecified thresholds for minimally important differences during and after treatment, except for a clinically meaningful improvement in FACT-M surgery subscale scores. In the individual patient-level analysis for EORTC QLQ-C30 subscales, the percentages of patients who reported clinically relevant scores for fatigue and cognitive impairment increased during treatment (at 9 months) compared with baseline. After treatment cessation (at 18 months), the percentage of patients who reported clinically relevant scores for fatigue decreased. However, the percentages of patients who reported clinically relevant scores for emotional, cognitive, and social impairment increased at 18 months compared with during treatment. Most patients with emotional impairment at 9 and 18 months did not experience disease recurrence (91% and 89%, respectively). These results confirm the real-world effectiveness and safety of nivolumab as an adjuvant treatment for patients with completely resected stage III or stage IV melanoma. Cancer-specific, disease-specific, and generic HRQoL were maintained during and after treatment. The percentage of patients reporting emotional and cognitive impairment increased after treatment cessation, emphasizing the need for further investigation and tailored supportive care in these patients.

Health-Related Quality of Life at Five Years for a Randomized Trial of Tri-Modality Therapy with I-125 Brachytherapy, External Beam Radiation Therapy, and Short- vs. Long-Term Androgen Deprivation Therapy for High-Risk Localized Prostate Cancer (TRIP)

To describe the patient-reported health-related quality of life (HR-QoL) outcomes at five years for a multicenter randomized trial of tri-modality therapy with iodine-125 brachytherapy, external beam radiation therapy (EBRT), and short- versus long-term androgen deprivation therapy (ADT) for high-risk localized prostate cancer (TRIP/TRIGU0907). A total of 332 men with high-risk prostate cancer were randomized to either 6 months of ADT (n = 165) or 30 months of ADT (n = 167) in conjunction with combined modality radiation therapy. For the HR-QoL assessment, general HR-QoL and disease-specific HR-QoL were measured using the Japanese version of the Medical Outcomes Study 8-items Short-Form Health Survey (SF-8) and the Expanded Prostate Cancer Index Composite (EPIC). Patient-reported outcome questionnaires were filled out before ADT initiation, and five years after. Scores were reported as mean with the standard deviation. QoL end points were assessed as the change between pre and post treatment using paired student t-test. Changes in the International Prostate Symptom Scores (IPSS) score, including total score and subscores, were also evaluated. The study was powered according to the primary endpoint of biochemical progression free survival with HR-QoL as a secondary endpoint. In addition, recovery of testosterone level (300ng/dL or higher) was calculated as the cumulative incidence curve and compared between arms by log-rank test. The cumulative incidence of biochemical progression, and salvage ADT treatment were not different between the arms. Mean domain scores at baseline were well balanced between the two arms in all HR-QoL. There were no differences in the SF-8 assessment and the total and subscore EPIC assessments between the arms. The average sexual function score was lower in short arm versus long arm; 16.24 versus 20.24 at baseline, but not different at five years, 9.96 versus 7.78 (p = 0.164). There were no significant differences between the arms for the total and subscore IPSS. Significantly higher percentage of patients, 71.7% in the short arm recovered to a normal testosterone level at 6 years after the initiation of ADT compared to 43.2% in long arm (p<0.0001). At five years after ADT initiation, there were no significant differences in all score changes between the two arms with general HR-QoL and disease-specific HR-QoL. Most of HR-QoL returned to baseline level, and sexual function scores were low from baseline in this population. Two-years' adjuvant ADT did not affect HR-QoL at five years, although it significantly retarded testosterone recovery compared to 6 months of hormone therapy.

Obtaining preference scores for an abbreviated self-completion version of the Teen-Addiction Severity Index (ASC T-ASI) to value therapy outcomes of systemic family interventions: a discrete choice experiment

BackgroundSystemic family interventions for adolescents with problems of substance use and/or delinquency are increasingly focused subject of economic evaluations. Treatment effects go beyond improvements in commonly measured health-related quality of life (HRQOL). The Teen-Addiction Severity Index (T-ASI) was identified as capable of capturing these broad outcomes. However, it lacks preference-based scores. An abbreviated self-completion version (ASC T-ASI) was created and validated, covering the T-ASI domains substance use, school, work, family, social relationships, justice, and mental health. This study aimed to obtain societal preference scores for the ASC T-ASI.MethodsPreferences were elicited in a sample of the Dutch general adult population (n = 1500), using a web-based Discrete Choice Experiment. Choice tasks included two unlabeled alternatives with attributes and levels corresponding to the domains and levels of the ASC T-ASI. A pilot study (n = 106) informed priors, optimal presentation, and number of choice tasks applied in the main study. Data were analyzed using a mixed multinomial logit model.ResultsPreference scores were logically ordered, with lower scores for worse ASC T-ASI states. Scores were most influenced by reductions in problems concerning the domains substance use, mental health, justice, and family. Tariffs were calculated for each ASC T-ASI state, ranging from 0 (worst situation) to 1 (best situation).ConclusionsThe tariffs enable preference-based assessments of the broad effects of systemic family interventions for adolescents with problems of substance use and/or delinquency. The outcome reflects addiction-related rather than health-related utility and can be used next to generic HRQOL instruments in relevant economic evaluations. Given the source used for the preferences, interpretations and valuation of scores require attention.

Evaluation of the effects of periodontal status according to 2017 classifications on oral health-related quality of life and quality of life-related to general health: A cross-sectional study.

In patients with periodontal disease, various symptoms are observed along with inflammation. The impact of local and systemic inflammation on periodontal tissue is well-known; however, the impact of periodontal disease on the individual's quality of life is unclear. This study aimed to assess oral health-related and general health-related quality of life in patients undergoing maintenance treatment following treatment for periodontitis (RP-CPH), patients with gingivitis (G) and patients with Stage I periodontitis (SI-P) and to compare this with individuals with clinical periodontal health (IP-CPH). This study was comprised of cross-sectional periodontal assessment along with questionnaires. Oral health-related quality of life and general health-related quality of life were assessed using, respectively, the Oral Health Impact Profile-14 (OHIP-14) and Short-Form-36 (SF-36) questionnaires. Study participants were classified according to the classification of periodontal and peri-implant diseases and conditions established by the 2017 World Workshop. The OHIP-14 total scores for the 166 study participants (age range: 22-57) of the G (11.61 ± 3.21) and SI-P (13.03 ± 3.47) groups were significantly higher than the OHIP-14 total scores of the IP-CPH (1.09 ± 1.58) and RP-CPH (2.95 ± 2.58) groups. SF-36 scores were found to be significantly lower in the SI-P group in all subgroups compared to the G and IP-CPH groups. A correlation was found between early-stage periodontal disease and low levels of OHRQoL and GHRQoL. The health of periodontal tissues may have a positive effect on the quality of life.

Efficacy and safety of Lacticaseibacillus rhamnosus R0011 and Lactobacillus helveticus R0052 as an adjuvant for Helicobacter pylori eradication: a double-blind, randomized, placebo-controlled study

BackgroundHelicobacter pylori eradication is recommended as a way of providing symptomatic relief for dyspepsia. The limited efficacy of triple therapy is a major problem in many countries, including Thailand. Some probiotics have been shown to improve the H. pylori eradication rate and reduce side effects. This study aimed at evaluating the efficacy of probiotic (Lacidofil® STRONG) as adjuvant to standard triple therapy.MethodsThis randomized, double-blind, placebo-controlled study was conducted between July 2020 and June 2022. Eligible patients with H. pylori gastritis (i.e., n=90 out of the 160 patients screened) were randomized to receive 14-day standard triple therapy either with probiotics or with a placebo (N=45/group). The treatment regimen entailed 30 mg lansoprazole administered twice daily, 1,000 mg amoxicillin administered twice daily, and 1 g clarithromycin modified-release formulation administered once daily. A probiotic capsule containing Lacticaseibacillus rhamnosus R0011 and Lactobacillus helveticus R0052 (Lacidofil® STRONG) or placebo were given twice daily during the eradication therapy and for an additional 4 weeks. Successful H. pylori eradication was defined as a negative 13C-urea breath test at least 4 weeks after complete eradication.ResultsAs per-protocol analysis, eradication rates after the 14-day regimen with probiotic or placebo were 90.9% and 75.0% (p=0.047), respectively. Antibiotic susceptibility testing demonstrated high clarithromycin resistance (24%). For clarithromycin-resistant strains, there was no statistical difference in eradication rates between the probiotic and placebo groups. Furthermore, probiotic supplementation significantly reduced treatment side effects, including bloating (OR 0.27 [95% CI 0.10 to 0.75], p=0.012), diarrhea (OR 0.23 [95% CI 0.28 to 0.65], p=0.006), nausea (OR 0.05 [95% CI 0.01 to 0.36], p=0.003), and bitter taste (OR 0.14 [95% CI 0.03 to 0.69], p=0.015). In addition, the probiotic group had lower gastrointestinal symptom rating scale (GSRS) scores (1.46 ± 0.36 vs. 2.65 ± 0.66, p&amp;lt;0.001) and higher SF-36 health-related quality-of-life scores (63.3 ± 10.2 vs. 57.3 ± 13.4, p=0.020) after treatment than the placebo group.ConclusionThe probiotic adjuvant with 14-day standard triple therapy improved the H. pylori eradication rate. Supplementation with Lacidofil® STRONG during the 2-week eradication treatment and 4-week follow-up phase can help to reduce the gastrointestinal side effects of eradication therapy and increase patients’ general health-related quality of life.