Disease-specific Quality Of Life Research Articles

Quality of Life for Patients with Sporadic Small Vestibular Schwannomas Following Middle Fossa Craniotomy.

To evaluate quality-of-life outcomes for patients with vestibular schwannomas (VS) undergoing a middle cranial fossa (MCF) approach. Prospective study from 2018 to 2023. Tertiary academic institution. Adults with sporadic VS. MCF. The primary outcome measure was the change in preoperative and 1-year postoperative Penn Acoustic Neuroma Quality-of-life (PANQOL) scores. Secondary outcome measures included hearing preservation and facial nerve function. Of the 164 patients who underwent MCF for sporadic VS, 78 patients elected to voluntarily complete preoperative PANQOL assessments prior to surgery. Seventy-one (91%) of those 78 patients completed postoperative PANQOL surveys. Fifty (70%) of the respondents were female and the median age was 48 years (range, 27-71 years). Overall, at 1-year postsurgery, a minimal clinically important difference (MCID) was obtained in the hearing (mean difference, 10.5; 95% confidence interval [CI], 4.3-16.7) and anxiety (mean difference, 18.8; 95% CI, 11.7-25.9) domains. For patients with hearing preservation (n = 48, 68%), MCIDs were reached in the hearing (mean difference, 13.4; 95% CI, 6.3-20.6), anxiety (mean difference, 20.8; 95% CI, 11.8-29.9), energy (mean difference, 13.7; 95% CI, 3.6-23.8), pain (mean difference, 13.7; 95% CI, 3.6-23.8) domains, and overall PANQOL scores (mean difference, 12.7; 95% CI, 7.1-18.3). Postoperatively, 64 (90%) patients maintained a House-Brackmann I. To our knowledge, this is the largest study examining disease-specific QOL for VS patients undergoing MCF. Based on our institution's experience, MCF approach for small VS is associated with clinically meaningful improvements in QOL, hearing preservation, and excellent facial nerve outcomes.

Early Diagnosis and Treatment of COPD and Asthma — A Randomized, Controlled Trial

BackgroundMany persons with chronic obstructive pulmonary disease (COPD) or asthma have not received a diagnosis, so their respiratory symptoms remain largely untreated.MethodsWe used a case-finding method to identify adults in the community with respiratory symptoms without diagnosed lung disease. Participants who were found to have undiagnosed COPD or asthma on spirometry were enrolled in a multicenter, randomized, controlled trial to determine whether early diagnosis and treatment reduces health care utilization for respiratory illness and improves health outcomes. Participants were assigned to receive the intervention (evaluation by a pulmonologist and an asthma–COPD educator who were instructed to initiate guideline-based care) or usual care by their primary care practitioner. The primary outcome was the annualized rate of participant-initiated health care utilization for respiratory illness. Secondary outcomes included changes from baseline to 1 year in disease-specific quality of life, as assessed with the St. George Respiratory Questionnaire (SGRQ; scores range from 0 to 100, with lower scores indicating better health status); symptom burden, as assessed with the COPD Assessment Test (CAT; scores range from 0 to 40, with lower scores indicating better health status); and forced expiratory volume in 1 second (FEV1).ResultsOf 38,353 persons interviewed, 595 were found to have undiagnosed COPD or asthma and 508 underwent randomization: 253 were assigned to the intervention group and 255 to the usual-care group. The annualized rate of a primary-outcome event was lower in the intervention group than in the usual-care group (0.53 vs. 1.12 events per person-year; incidence rate ratio, 0.48; 95% confidence interval [CI], 0.36 to 0.63; P<0.001). At 12 months, the SGRQ score was lower than the baseline score by 10.2 points in the intervention group and by 6.8 points in the usual-care group (difference, −3.5 points; 95% CI, −6.0 to −0.9), and the CAT score was lower than the baseline score by 3.8 points and 2.6 points, respectively (difference, −1.3 points; 95% CI, −2.4 to −0.1). The FEV1 increased by 119 ml in the intervention group and by 22 ml in the usual-care group (difference, 94 ml; 95% CI, 50 to 138). The incidence of adverse events was similar in the trial groups.ConclusionsIn this trial in which a strategy was used to identify adults in the community with undiagnosed asthma or COPD, those who received pulmonologist-directed treatment had less subsequent health care utilization for respiratory illness than those who received usual care. (Funded by Canadian Institutes of Health Research; UCAP ClinicalTrials.gov number, NCT03148210.)

Disease-specific Quality of Life in Irish Children with Otitis Media with Effusion

Introduction: Otitis media with effusion (OME) is one of the most common diseases of childhood and causes significant morbidity for children. The benefits of ventilation tubes (VTs) are well established, but the subjective impact of surgery on Irish children’s quality of life (QoL) has not been studied. Methods: A prospective single-unit cohort study used a validated QoL survey (Otitis Media-6 [OM-6]) to determine the impact of VT placement on QoL. The OM-6 survey uses a Likert scale, with the higher the value on the Likert scale, the poorer the QoL perceived. Results: Seventy-six children with a mean (range) age of 6 (0.5–13) years were recruited for this study. The overall mean OM-6 score for the 76 children was 3.2. Twenty-six children proceeded to surgery. The mean OM-6 score in this cohort preoperatively was 4.5 and reduced to 1.35 at 3 months post-VT placement. Conclusion: This study highlights the poor QoL experienced by Irish children with OME. The OM-6 scores are considerably higher in our series than previously published international series. VT insertion leads to an improvement in QoL scores. This validated questionnaire should be a routine adjunct in the holistic management of children with OME.

Predictive value of quality of life as measured by KCCQ in heart failure patients: A meta-analysis.

Studies on the predictive ability of disease-specific health quality of life (QoL) in patients with heart failure (HF) have produced conflicting results. To address these gaps in knowledge, we conducted a meta-analysis to evaluate the predictive value of QoL measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) in patients with HF. We searched PubMed, and Embase databases to identify studies investigating the predictive utility of baseline QoL measured by the KCCQ in HF patients. The outcome measures were all-cause mortality and HF hospitalisation. The predictive value of QoL was expressed by pooling the adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for the bottom versus the top category of KCCQ score or for per 10-point KCCQ score decrease. Twelve studies reporting on 11 articles with a total of 34,927 HF patients were identified. Comparison of the bottom with the top KCCQ score, the pooled adjusted HR was 2.34 (95% CI 2.10-2.60) and 2.53 (95% CI 2.23-2.88) for all-cause mortality and HF hospitalisation, respectively. Additionally, a 10-point decrease in KCCQ score was associated with a 12% (95% CI 7%-16%) increased risk of all-cause mortality and a 14% (95% CI 13%-15%) increased risk of HF hospitalisation. Poor health-related QoL as determined by the lower KCCQ score, was associated with an increased risk of all-cause mortality and HF hospitalisation in patients with HF. Measuring disease-specific health-related QoL using the KCCQ score may provide valuable predictive information for HF patients.

Impact of Air Pollution and Allergic Status on Health-Related Quality of Life among University Students in Northern Thailand.

Global awareness of ambient air pollution has heightened due to its detrimental impact on health, particularly in regions with elevated PM2.5 levels. Chiang Mai has emerged as an area experiencing the highest PM2.5 levels in Thailand. to examine the prevalence of respiratory allergies and assess the impact of air pollution on the health-related quality of life (QoL) among university students in Chiang Mai. Chiang Mai University (CMU) and Maejo University (MJU) students were recruited. The Global Asthma Network (GAN) questionnaire screened for respiratory allergies (RAs). The disease-specific QoL questionnaire (Rcq-36) was administered twice during low-PM2.5 and high-PM2.5 seasons to evaluate air pollution's impact on health-related QoL. Those showing potential RAs underwent a skin prick test (SPT) to investigate allergic sensitization. Out of 406 participants, 131 (32%) reported respiratory allergies. Among those undergoing SPT, a high rate (82.54%) had positive results. Across both universities, students reported significantly lower QoL in multiple domains, particularly respiratory, eye, sleep, and emotional well-being, during the high-PM2.5 season. This aligned with their poorer self-reported health on a visual analog scale (VAS; p-value < 0.01). PM2.5 levels significantly impacted social functioning for CMU students (p-value = 0.001) and role limitations for MJU students (p-value < 0.001). Notably, participants without respiratory allergies (non-RAs) were more significantly affected by PM2.5 than RA participants in almost all parameters, despite experiencing fewer baseline symptoms. Respiratory allergies, particularly allergic rhinitis, are prevalent among university students in Chiang Mai. This study underscores the substantial negative impact of ambient air pollution on QoL for both allergic and non-allergic students.

The PlexiQoL, a patient-reported outcome measure on quality of life in neurofibromatosis type 1-associated plexiform neurofibroma: translation, cultural adaptation and validation into the Dutch language for the Netherlands.

Half of the patients with Neurofibromatosis type 1 (NF1) develop one or more tumours called plexiform neurofibromas, which can have a significant impact on Quality of Life (QoL). The PlexiQoL questionnaire is a disease-specific QoL measure for adults with NF1-associated plexiform neurofibromas. The aim of this study was to adapt and validate a Dutch version of the PlexiQoL for the Netherlands. The PlexiQoL was translated using the dual-panel methodology, followed by cognitive debriefing interviews to assess face and content validity. The psychometric properties were evaluated by administering the questionnaire on two separate occasions to a sample of adults with NF1 and plexiform neurofibromas. Feasibility was evaluated by the presence of floor/ceiling effects. Reliability was assessed by evaluating Cronbach's alpha coefficient and test-retest reliability, using Spearman's rank correlation coefficients. Mann-Whitney U tests were used to check for known group validity. The Nottingham Health Profile (NHP) questionnaire was used as comparator questionnaire to evaluate convergent validity. The translation and cognitive debriefing interviews resulted in a Dutch version of the PlexiQoL that reflected the original concept and underlying semantic meanings of the UK English version. Forty participants completed the validation survey. The Dutch PlexiQoL demonstrated excellent internal consistency (Cronbach's α 0.825) and test-retest reliability (Spearman correlation coefficient 0.928). The questionnaire detected differences in PlexiQoL scores between participants based on self-reported general health and disease severity. Convergent validity was confirmed for relevant NHP subsections. The Dutch PlexiQoL demonstrated excellent psychometric properties and can be reliably used to measure plexiform neurofibroma-related QoL in adults with NF1 in the Netherlands.

Disease-specific quality of life as part of the long-term follow-up for children born with esophageal atresia in an academic unit in South Africa-a pilot study.

As neonatal mortality rates have decreased in esophageal atresia (EA), there is a growing focus on quality of life (QoL) in these children. No study from Africa has reported on this topic. This pilot study aimed to describe disease-specific QoL in EA children and its applicability as part of long-term follow-up in an academic facility in South Africa. Disease-specific QoL in children born with EA was assessed utilizing the EA-QoL questionnaire for children aged 2-17years during a patient-encounter. The parent-report for children aged 2-7years compromised 17 items categorized into three domains: eating, physical health and treatment, and social isolation/stress. The 24-item EA-QL questionnaire for children aged 8-18 (child- and parent-report) explored four domains: eating, body perception, social relationships, and health and well-being. A total of 13 questionnaires for children aged 2-7years were completed by five parents. A negative perceived impact on their child's eating was reported by 46-92% of parents, and less impact in the other two domains. A total of 27 questionnaires were completed by eight children aged 8-17years and 10 parents. Similar percentages children and parents reported a negative impact in the eating, social relationships, and body perception domains. More than half reported a negative impact on the child's health and well-being. This study supports the concept that assessment of disease-specific QoL should play a vital role in the comprehensive follow-up approach for children born with EA. We identified that parents of younger children were more likely to report eating disorders, whereas parents of older children were more likely to report health difficulties with different perceptions when it came to the child's scar.

Evaluation of Perioperative Clinical Parameters and Quality of Life in Patients Undergoing Radical Perineal or Retropubic Prostatectomy: A Prospective Randomized Study

Objective: The objective of study is to investigate the effects of radical retropubic and perineal prostatectomy methods in addition to the effect of pelvic lymph node dissection on perioperative morbidities, oncological outcomes and 1-year quality of life in patients with clinically local stage prostate cancer. Material and methods: Patients admitted to our clinic between January 2013 and March 2015 and diagnosed with clinically localized stage prostate cancer were included. A total of 103 patients were randomized into 3 groups in which 38 patients received radical perineal prostatectomy(RPP), 31 had radical retropubic prostatectomy(RRP), and 34 RRP with pelvic lymph node dissection(PLND). Age, comorbidities, preoperative Gleason scores and serum prostate-specific antigen(PSA) data as well as the surgical parameters, clinical and pathological stages, and 1-year follow-up data were recorded for each patient.“Extended prostate cancer index composite (EPIC)” and “SF-12v2™ Health Survey(Version 2.0)” questionnaires were used for overall and disease-specific quality of life at month 0, 1, 6 and 12 visits. Results: No difference was found between the groups with regard to preoperative data such as age, serum PSA levels, clinical stage, biopsy Gleason score and Charlson comorbidity index while intraoperative data for the amount of bleeding and the average amount of transfusion were significantly lower in RPP group(RPP:645cc, RRP:960cc, RRP+PLND:890cc).1-year recurrencefree survivals for RPP, RRP, and RRP+PLND groups were 9.9 months, 11.2 months and 10.2 months, respectively, with no significant difference.Overall and prostate cancer-specific quality of life was similar for all 3 groups.No additional benefit with nerve-sparing surgery was shown in any of the groups in terms of incontinence and erectile functions. Conclusion: Perineal dissection is beneficial in terms of the amount of bleeding and blood transfusion while prolonged postoperative drainage and wound infection rates are higher compared to retropubic approach.All 3 groups were similar in urinary, sexual, gastrointestinal and hormonal functions as well as the quality of life.

Do children with asymptomatic ventricular preexcitation have similar quality of life as healthy children?

To our knowledge, no studies have assessed quality of life (QoL) in asymptomatic children with a preexcitation electrocardiogram pattern. To evaluate the QoL of children with asymptomatic Wolff-Parkinson-White (WPW) syndrome. This study involved QoL assessment of 31 children with asymptomatic preexcitation and 82 healthy children using the WHOQOL-BREF and the Pediatric Arrhythmia Related Score (PARS), a specific questionnaire that we have developed, which is related to patients' feelings and observations concerning arrhythmia. There were no significant differences between the two groups in all the measured domains; however, there were significant differences regarding general satisfaction with their health condition (P = 0.01). There were no differences in general satisfaction with the QoL, but WPW children more often experienced palpitations than the control group (P <0.001) and were more likely to feel sad (P = 0.046) and nervous (P = 0.04) compared to healthy children. The children with WPW were more dissatisfied with their health compared to healthy children. Although both groups of children had similar levels of satisfaction with their QoL, some areas of physical and psychological parameters of QoL were worse in WPW children. The PARS questionnaire is a useful tool as a disease-specific QoL instrument, which supplements the general questionnaire and aids in clinical practice and decision-making.

Exploring the Link between Social Support and Patient-Reported Outcomes in Chronic Obstructive Pulmonary Disease Patients: A Cross-Sectional Study in Primary Care.

We aimed to explore the link between social support and various patient-reported outcome measures (PROMs) in primary care patients with COPD. This was a cross-sectional study with 168 patients with COPD from six primary care centers in Crete, Greece. We collected data on sociodemographic characteristics, medical history, disease-specific quality of life, the COPD Assessment Test (CAT), fatigue, the Fatigue Severity Scale (FSS), phycological parameters, Patient Health Questionnaire-9, General Anxiety Disorder-7, sleep complaints, the Pittsburg Sleep Quality Index, the Athens Insomnia scale (AIS), and the Epworth Sleepiness Scale. Social support was measured using the Multidimensional Scale of Perceived Social Support (MSPSS). Out of 168 patients with COPD, 114 (68.9%) exhibited low levels of social support. Low social support (MSPSS total ≤ 5) was positively associated with COPD symptoms (CAT score ≥ 10) (OR = 3.97, 95%CI:1.86-8.44; p < 0.01), fatigue (FSS ≥ 36) (OR = 2.74, 95%CI:1.31-5.74; p = 0.01), and insomnia symptoms (AIS ≥ 6) (OR = 5.17 95%CI:2.23-12.01; p < 0.01), while the association with depressive symptoms (PHQ-9 ≥ 10) was marginally significant (OR = 3.1, 95%CI:0.93-10.36; p = 0.07). Our results suggest that lower levels of social support are positively associated with PROMs in patients with COPD. Therefore, our findings show an additional way to improve the overall health of patients with COPD in primary care by putting social support at the epicenter of actions.

Associations of Upper-Extremity Exercise Capacity and Grip Strength With Cognitive Domains in Patients With COPD.

Cognitive impairment (CI), which has been reported in COPD, has been related to physical performance. However, the association between CI and upper-extremity functions is unknown. We aimed to compare upper-extremity exercise capacity and grip strength between subjects with COPD with and without CI and to determine the relationship of upper-extremity functions with specific cognitive domains. In this cross-sectional study, 76 subjects with COPD (mean age 66.8 ± 7.5 y, FEV1% 47.12 ± 14.10) were classified as with and without CI according to the Montreal Cognitive Assessment. Clinical characteristics, upper-extremity exercise capacity (6-min pegboard ring test [6PBRT]), grip strength (hand dynamometer), dyspnea severity (modified Medical Research Council dyspnea scale), disease-specific health status (COPD Assessment Test), and disease-specific quality of life (St George Respiratory Questionnaire) were compared between groups, and the relationship of upper-extremity functions with cognitive subdomains was analyzed by multivariate regression analysis. The number of 6PBRT rings (P = .01) and the grip strength (P = .033) were lower in subjects with CI. Subjects with CI had lower FEV1% (P = .038), arterial oxygenation (P = .002), exercise habits (P = .033), health status (P = .01), quality of life (P = .042); and higher dyspnea (P < .001), smoking consumption (P = .032), emergency admission (P = .02), and hospitalization (P = .042). The adjusted model showed that executive functions and attention were related to upper-extremity capacity (β = 14.4 and β = 10.2, respectively) and hand-grip strength (β = 1.85 and β = 1.49, respectively). These findings suggest that upper-extremity functions might be decreased especially concerning executive functions and attention in subjects with COPD with CI.

The development of a cryptoglandular anal fistula quality of life scale (AF-QoL).

Quality of life (QoL) is a crucial and core outcome in assessing the effectiveness of treatments for cryptoglandular anal fistula. Despite its extensive impact, there is a lack of patient-centred, disease-specific QoL measurement instruments of adequate quality. The aim of this study is to develop a disease-specific measurement instrument that can accurately measure QoL for patients with cryptoglandular anal fistula. Semi-structured qualitative patient interviews and a systematic review of current instruments were used to generate items for the draft instrument. This underwent successive rounds of cognitive interviews to refine its wording and structure. Individual item and overall scale content validity were determined by asking experts to rate the relevance of each item and those deemed irrelevant were removed. The final instrument then underwent psychometric testing and test-retest analysis to determine its sensitivity and stability. A total of 148 patients were involved in item generation, scale development and psychometric testing. A 22-item measurement instrument has been developed; it is scored on a scale of 0-100, where 0 indicates the worst QoL and 100 demonstrates perfect QoL. The scale demonstrates excellent internal consistency (Cronbach-α = 0.927), strong content and construct validity [correlation with Perianal Disease Activity Index = -0.713, Hospital Anxiety and Depression Anxiety (-0.659) and Depression (-0.673) subscales and Short Form-12 physical (0.609) and mental (0.589) component scales] and strong reliability and responsiveness. We have developed a cryptoglandular Anal Fistula Quality of Life scale (AF-QoL), a comprehensive, disease-specific patient reported outcome measure assessing QoL in patients with cryptoglandular anal fistula.

Impact of Chronic Suppurative Otitis Media on Quality of Life and Psychological Well-Being: A Cross-Sectional Study.

Chronic suppurative otitis media (CSOM) is a prevalent and persistent middle ear condition that not only affects auditory health but also potentially influences various aspects of an individual's life. This study explores the correlation between CSOM, depression, anxiety, and stress, using the 21-item Depression, Anxiety, and Stress Scale (DASS 21), also assessing quality of life (QoL) using the Chronic Ear Survey (CES) questionnaire. The primary objective of this study was to gather prospective audiological data along with information on both disease-specific quality of life and psychological well-being, utilizing validated measurement instruments. This cross-sectional study was conducted at a tertiary care center in Central India, involving 182 patients with CSOM. The study included individuals aged 18 years and above diagnosed with CSOM in at least one ear. Patients with a history of psychological disorders, head injury, and those with comorbidities such as diabetes, hypertension, and chronic heart diseases were excluded. Pure tone audiometry was employed for hearing evaluation, while the assessment of psychological well-being utilized the DASS 21questionnaire. Furthermore, the quality of life was evaluated using the CEStool. From the initial cohort of 182 patients diagnosed with CSOM, 32 were excluded based on predefined criteria, resulting in a final sample of 150 patients. The cohort, with a mean age of 34.3 years, exhibited a predominantly female population (63.3%). Psychological assessments using DASS 21 revealeddepression in 22 (14.7%) patients and anxiety in 23 (15.3%) patients. Among those with depression, majority of the participants had mild depression. Similarly, among those with anxiety, the majority were found to be experiencing mild anxiety. Bilateral CSOM demonstrated a higher prevalence of anxiety and depression, establishing a significant association. QoL parameters, assessed by the Chronic Ear Survey, indicated a more adverse impact in bilateral cases across all categories except symptoms. Correlation analysis between psychological well-being, quality of life, and hearing loss severity yielded statistically significant results. CSOM with the symptom of hearing loss can lead to reduced QoL and psychological well-being in the affected individuals. This study highlights the psychological impact of CSOM, particularly in bilateral cases and severe hearing loss. Integrating psychological support into treatment plans is crucial for comprehensive patient care. Regular assessments are essential for guiding timely interventions, ensuring a holistic approach to enhance both quality of life and psychological well-being in individuals affected by CSOM.

Translation and validation of the Hirschsprung and anorectal malformation quality of life (HAQL) questionnaire in a Danish Hirschsprung population

BackgroundHirschsprung’s disease (HD) may result in an impaired quality of life (QoL) due to bowel problems, postoperative complications and other health-related issues. The Hirschsprung and Anorectal Malformation Quality of Life (HAQL) questionnaire is a disease-specific instrument developed in the Netherlands to measure the QoL in patients with HD and anorectal malformations. The aim of this study was to translate, culturally adapt and validate HAQL in a Danish Hirschsprung population.Material and methodsTranslation and cultural adaptation were performed according to international guidelines. Invitations to participate in the validation were sent to 401 patients operated for HD during the period from 1985 to 2012. A total of 156 patients completed the translated and culturally adapted Danish versions of HAQL and 35 parents of children and adolescents completed the corresponding parent questionnaire. Reliability was evaluated in terms of internal consistency using Cronbach’s α and test–retest reliability using Intraclass Correlation Coefficient for the retest step. Known groups comparison was performed with comparison of mild HD (defined as recto-sigmoidal HD) and serious HD (defined as more proximal disease).ResultsThe internal consistency of the dimensions was overall satisfactory for adults and adolescents but more problematic for children, where Cronbach’s α was less than 0.7 in 60% of the dimensions. For both children and adolescents, the α-value was unsatisfactory for social functioning, emotional functioning, and body image. The test–retest reliability was overall good. The known groups comparison was only able to demonstrate a significant difference between mild and severe HD within one dimension.ConclusionsThe translated version of the HAQL questionnaires provides an overall reliable instrument for evaluating disease-specific QoL in a Danish HD population, but it is important to acknowledge the limitations of the questionnaire, especially in children and adolescents.

Quality of life after brain injury-overall scale, Japanese version: assessment of reliability and validity

ABSTRACT This study analyzed the linguistic and psychometric validation of the Japanese version of the Quality of Life after Brain Injury-Overall Scale (QOLIBRI-OS) consisting of six items which cover several TBI-relevant domains. We hypothesized that the Japanese version has good reliability, convergent validity, and divergent validity, compared with its long version, the 37-item QOLIBRI. The QOLIBRI-OS Japanese version was forward and back-translated from the English version. In total, 129 individuals participated in this study after experiencing a traumatic brain injury and attending clinics, rehabilitation centers, and support centers in Japan. The structure of the QOLIBRI-OS was investigated by confirmatory factor analyses and compared with the QOLIBRI. Only one factor was extracted, and a model with one underlying factor had a good fit. The QOLIBRI-OS showed good-to-excellent internal consistency and test-retest reliability. The QOLIBRI-OS was positively correlated with the QOLIBRI, Short Form Health Survey-36 version 2, and Glasgow Outcome Scale Extended, and negatively correlated with the Hospital Anxiety and Depression Scale. The results suggest that the QOLIBRI-OS Japanese version is a reliable and valid tool for assessing disease-specific health-related QOL in individuals after traumatic brain injury in Japan.

P1079 Mindfulness-based cognitive therapy to reduce psychological distress in patients with Inflammatory Bowel Disease: first results of a multicentre randomised controlled trial (MindIBD)

Abstract Background Many patients with Inflammatory Bowel Diseases (IBD) suffer from psychological distress and fatigue. Moreover they report a reduced quality of life. The availability of psychosocial treatment options is limited. As mindfulness-based cognitive therapy (MBCT) has been shown to reduce psychological distress and fatigue, and improve quality of life in other populations, MBCT might also be effective in patients with IBD. Methods The MindIBD study was a prospective, multicentre, randomised controlled trial, conducted in one academic and three general hospitals in the Netherlands. Patients of 16 years and older with a confirmed IBD diagnosis were eligible if the IBD was in remission (based on faecal calprotectin &amp;lt;250 mg/kg and no changes in IBD medication for at least three months) and they experienced at least mild psychological distress (based on Hospital Anxiety and Depression Scale (HADS) total score ≥ 11). Participants were allocated in the intervention group (MBCT plus treatment as usual) or control group (treatment as usual alone). Assessments were conducted at baseline, post-intervention (3 months) and at 6, 9 and 12 months after baseline. Primary outcome was the effect on psychological distress post-intervention. Secondary outcomes included fatigue, perceived disease control, disease activity, disease-specific quality of life and positive mental health. This trial was registered at ClinicalTrials.gov: NCT04646785. Results A total of 142 IBD patients were randomly assigned to the intervention group (n=70) or the control group (n=72). The study population had a median age of 50 years (IQR 39-59 years), consisted of 91 women (64%) and 68 participants (48%) were diagnosed with Crohn’s disease. Post-intervention, participants in the intervention group showed a mean decrease on the HADS total of 4.7 ± 6.3 points compared to a mean decrease of 1.2 ± 5.2 points in the control group. This difference in improvement of psychological distress was statistically significant (p&amp;lt;0.001), and this benefit was maintained during follow-up (p=0.005). MBCT did also result in a significant improvement on fatigue (p=0.022) and positive mental health (p=0.022) post-intervention. These improvements remained in favour of the intervention group during follow-up, although not significantly different. No differences were found on perceived disease control, disease activity and disease-specific quality of life. Conclusion MBCT reduces psychological distress and improves fatigue and positive mental health. Therefore MBCT can be considered as a valuable addition to the limited psychosocial interventions for patients with IBD to improve psychological distress, fatigue and positive mental health.

N02 Inflammatory bowel disease patients with impaired quality of life on biologic therapy benefit from the support of an IBD nurse specialist: Results of a randomized controlled trial in Germany (IBDBIO-ASSIST study) - The IBD nurses perspective

Abstract Background IBD nurses play an important role in the Multidisciplinary Team of managing patients with IBD. IBDBIO-ASSIST was a randomised controlled trial assessing the efficacy of care provided by an IBD nurse specialist in improving health-related quality of life (QoL) in IBD patients on biologic therapy in an outpatient setting in Germany. Methods In total, 1086 IBD patients on biologic therapy were randomly assigned to either a control group (CG) receiving usual IBD care or an intervention group (IG) receiving additional care from an IBD nurse. Two IBD nurses per site received an extra study specific IBD training before including patients. The primary outcome was disease-specific QoL (sIBDQ) assessed at months (M) 6, 12, and 18. In addition, IBD nurses provided a final assessment of various aspects of their work in the context of the study at M6 (T0) and M15 (T1), and patients were asked about their satisfaction level with the IBD nurses. Results The analysis of patients with impaired QoL at baseline (EQ-VAS &amp;lt; 75 [median]), showed an improvement in sIBDQ over 6 M that became significant at M12 and remained significant through M18 (baseline: IG 4.24; CG 4.31; M18: IG 5.02; CG 4.76; P= .017) (Table 1). Regarding the 5 aspects of fun, usefulness, successful discussions in consultations with patients, successful support of patients, and appreciation by patients, the nurses expressed positive assessments (“completely” and “rather”) at both measurement points, with values of more than 90% (Fig. 1). About 20% to 30% of the nurses reported being rather dissatisfied with two aspects of their jobs: time and space resources for discussions and recognition by physicians. 94% of patients in the IG felt that the additional care provided by the IBD nurses was highly beneficial. Conclusion IBD patients with impaired QoL derived a significant benefit from the additional care provided by an IBD nurse specialist, leading to meaningful improvements in sIBDQ over the long term. The survey results from the IBD nurses and patients in the IG revealed a very positive perception of the new form of care. It is noteworthy that an improvement in care provision was reported both by the nurses and the participating patients. Some physicians also experienced benefits from the intervention as they were relieved of certain time-consuming tasks by the IBD nurses. It should be noted that more than 20% of the IBD nurses did not feel sufficiently appreciated by physicians, and about 30% criticised the lack of time and space resources. When introducing the IBD nurse-led care concept into usual practice, these aspects should be considered.

Ecological momentary assessment of pelvic pain and urinary urgency variability in urologic chronic pelvic pain syndrome and their association with illness impact and quality of life: Findings from the multidisciplinary approach to the study of chronic pelvic pain symptom patterns study.

This study tested the hypothesis that ecological momentary assessment (EMA) of pelvic pain (PP) and urinary urgency (UU) would reveal unique Urologic Chronic Pelvic Pain Syndrome (UCPPS) phenotypes that would be associated with disease specific quality of life (QOL) and illness impact metrics (IIM). A previously validated smart phone app (M-app) was provided to willing Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) participants. M-app notifications were sent 4-times daily for 14 days inquiring about PP and UU severity. A clustering algorithm that accounted for variance placed participants into PP and UU variability? clusters. Associations between clusters and QOL and IIM were then determined. A total of 204 participants enrolled in the M-app study (64% female). M-app compliance was high (median 63% of surveys). Cluster analysis revealed k = 3 (high, low, none) PP clusters and k = 2 (high, low) UU clusters. When adjusting for baseline pain severity, high PP variability, but not UU variability, was strongly associated with QOL and IIM; specifically worse mood, worse sleep and higher anxiety. UU and PP clusters were associated with each other (p < 0.0001), but a large percentage (33%) of patients with high PP variability had low UU variability. PP variability is an independent predictor of worse QOL and more severe IIM in UCPPS participants after controlling for baseline pain severity and UU. These findings suggest alternative pain indices, such as pain variability and unpredictability, may be useful adjuncts to traditional measures of worst and average pain when assessing UCPPS treatment responses.

Pre-treatment expectations and their influence on subjective symptom change in Crohn's disease

BackgroundTreatment expectations reportedly shape treatment outcomes, but have not been studied in the context of multimodal therapy in Crohn's disease (CD). Therefore, the current study investigated the role of treatment expectations for subjective symptom changes in CD patients who have undergone an integrative multimodal therapy program. MethodsValidated questionnaires were completed at the start of the treatment program and post intervention. Pre-treatment expectations and experienced symptom change were assessed with the Generic Rating Scale for Previous Treatment Experiences, Treatment Expectations, and Treatment Effects (GEEE); stress levels were quantified with the Perceived Stress Scale (PSS-10) and disease specific quality of life was quantified with the disease-specific Inflammatory Bowel Disease Questionnaire (IBDQ). We performed multiple linear and Bayesian regression to determine how expectations related to symptom change. ResultsN = 71 CD patients (66.2% female) were included. Stronger expectations regarding symptom improvement (b = 0.422, t = 3.70, p < .001) were associated with higher experienced symptom improvement. Additionally, Bayesian analysis provided strong evidence for including improvement expectations as a predictor of improvement experience (BFinclusion = 13.78). ConclusionsIn line with research in other disorders, we found that positive treatment expectations were associated with experienced symptom improvement. In contrast, we found no indication that an experience of symptom worsening was associated with positive or negative baseline treatment expectations. Induction of positive expectations might be a potential avenue for improving treatment outcomes in CD therapy.

Single-centre prospective cohort study investigating the associations and one-year trends of frailty, cognition, disability and quality of life pre- and post-intervention for chronic limb-threatening ischaemia

Abstract Background: Half of people with chronic limb-threatening ischaemia (CLTI) have frailty. This study aimed to describe the associations of frailty with cognition, disability and quality of life (QoL) among CLTI patients over 1 year following surgical or endovascular procedures. Methods: A single-centre prospective cohort study was undertaken. Patients undergoing a procedure for CLTI between May 2019 and May 2021 were eligible (minimum age &gt;65 initially; &gt;50 from November 2019). Participants underwent preoperative assessments for frailty, physical and cognitive function, disability, mood, disease-specific QoL (Vascular QoL questionnaire (VascuQoL)) and generic health-related QoL (EuroQoL EQ-5D-5L). Follow-up was at 3 months (clinic or telephone) and 12 months (telephone). Baseline frailty was assessed using both the Edmonton frail scale (EFS) and the clinical frailty scale (CFS). Frailty during follow-up was re-assessed at 3 and 12 months using the CFS as it can be performed via telephone. Associations of baseline frailty with disability, QoL and mood scores during follow-up were investigated using repeated measures mixed models. Results: Ninety-nine patients completed the baseline assessments. Forty-five (45%) were classified as frail by the EFS. Frailty was associated with a higher prevalence of cognitive impairment based on the Montreal cognitive assessment (52% vs 17%; p&lt;0.001). Eighty-seven patients were eligible for follow-up. Baseline frailty (EFS) was associated with worse QoL scores at all timepoints (VascuQoL p=0.001; EQ-5D-5L p&lt;0.001). Both those with and without frailty at baseline (EFS) had modest improvement in QoL scores at 12 months (VascuQoL p&lt;0.001; EQ-5D-5L p=0.001). Barthel index (disability) scores were lower for those with frailty at baseline (EFS) (p&lt;0.001) and decreased slightly over 12 months for both groups (p=0.007). Five patients (12%) transitioned from frailty to non-frailty at 12 months based on the CFS. However, 10 patients (23%) transitioned from non-frailty to frailty. Conclusions: CLTI patients with frailty have worse QoL and greater disability both pre- and post-intervention. However, they demonstrate similar QoL benefit to those without frailty at 1 year following intervention. Baseline frailty assessment is important to inform prognostic discussions, expectations and shared decision making in CLTI.