Disease-specific Quality Research Articles

PB0449 Impact of Self-Reported Race on Villalta Scale Scores and Correlation with Venous Disease Specific Quality of Life: An Exploratory Analysis of the ATTRACT Trial

PB0449 Impact of Self-Reported Race on Villalta Scale Scores and Correlation with Venous Disease Specific Quality of Life: An Exploratory Analysis of the ATTRACT Trial

The Impact of Bilateral Stone Disease on Patients' Disease Progression and Health-Related Quality of Life.

Purpose: Patients with recurring kidney stone events can expect significant morbidity and functional impairment. Few studies have evaluated the effect of bilateral kidney stones on disease progression and quality of life. We wanted to determine the association of bilateral stone disease on age of onset, and the impact on number of stone events and individual kidney stone disease-specific health-related quality of life (HRQOL) by analyzing the validated and prospectively collected Wisconsin Stone Quality of Life (WISQOL) database. Materials and Methods: We studied 2906 stone patients from 16 centers in North America after having completed the WISQOL questionnaire from 2014 to 2019. Kidney stone formers were assessed if kidney stones were bilateral or unilateral on imaging. Analysis with a chi-square test compared categorical variables. Bilateral kidney stone disease and its impact on HRQOL were evaluated through a multivariable linear regression model. Results: Of 2906 kidney stone formers, 1340 had unilateral kidney stones and 1566 had bilateral kidney stones. We observed more frequently that patients with bilateral stones had an increased number of depression/anxiety symptoms, renal tubular acidosis, and rheumatoid arthritis (all p < 0.05). Patients with bilateral stones had a younger mean (standard deviation [SD]) age of kidney stone disease onset (37.2 ± 15.8 vs 46.4 ± 15.9 years of age, p < 0.001). Bilateral kidney stone formers had a higher mean (SD) number of stone events (11.3 ± 21.8) than unilateral kidney stone formers (3.0 ± 5.1) (p < 0.001). Within our multivariable analysis, we found that HRQOL was negatively affected by the presence of bilateral stones for kidney stone patients (β = -11.2 [confidence interval: -19.5 to -3.0] points, p < 0.05). Conclusions: Bilateral kidney stone formers had a younger age of kidney stone disease onset and a higher number of stone events compared with unilateral kidney stone disease formers. The presence of bilateral kidney stone disease negatively impacted HRQOL.

The Women@Heart NS Pilot Project: Rationale and Design of a Community-Based Peer Support Program for Women Living With Heart Disease in Nova Scotia

Cardiac rehabilitation is associated with lower mortality and improved psychosocial outcomes. However, disparities exist in referral and access to cardiac rehabilitation for Nova Scotian women, a situation exacerbated by the COVID-19 pandemic. Women@Heart (W@H) is a 4-month community-based peer support program developed and validated by the University of Ottawa Heart Institute, for women living with heart disease. The program aims to empower women with coping strategies, provide a supportive learning environment, and establish volunteer advocacy groups. The primary objective of this study is to evaluate the implementation feasibility of the W@H program for women living in Nova Scotia. The primary outcome is the implementation feasibility of W@H in Nova Scotia, measured through participant attendance and program completion rates. Peer leaders will record participant attendance. The psychosocial impact of W@H will be assessed using psychometric tools that measure the following: social support, adaptive coping, stress, symptoms of anxiety and depression, and health-related and disease-specific quality of life. Data will be collected using a pre- and post-program questionnaire administered to participants. The pilot program is expected to commence in the first quarter of 2024. One peer leader with lived experience of heart disease, who has previously completed the W@H program as a participant, has been trained. Participants have been identified through healthcare provider referral, self-referral, brochures, and peer-networking. Each cohort will consist of 5-10 participants. The W@H pilot project will assess the implementation feasibility and the impact of community-based peer support on the well-being of Nova Scotian women living with heart disease.

Test-retest repeatability for Fatigue Assessment Scale, Short-Form 6-Dimension and King's Sarcoidosis Questionnaire in people with sarcoidosis associated fatigue.

Patient related outcomes are important in sarcoidosis but the medium-term repeatability of the key patient reported outcome measure is not known. We aimed to test the repeatability of the Fatigue Assessment Scale (FAS), Short Form 6-Dimension (SF-6D), and King's Sarcoidosis Questionnaire (KSQ) in free living people with sarcoidosis associated fatigue. Twelve people with sarcoidosis associated fatigue completed the FAS, short form 36 questionnaire (SF-36) and the KSQ at baseline and 12 weeks. The SF-6D utility was calculated from the SF-36. The difference between baseline and 12 week assessments was measured. The interclass correlation (95% confidence interval) showed good agreement between the baseline and 3 months measurements: FAS 0.91 (0.74, 0.71), SF-36 0.98 (0.94, 1), KSQ 0.98 (0.93, 0.99), SF-6D utility 0.98 (0.93, 0.99). The baseline (standard deviation) FAS was 27.83 (5.86) and at 12 weeks was 27.25 (7.55) representing 0.58 difference (95% CI for difference (-1.89, 3.06)), SF-6D utility was 0.69 (0.16) at baseline and 0.68 (0.17) after 3 months representing at 0.00 (-0.03, 0.03) difference and corresponding values for KSQ were 59.12 (18.68) and 56.91 (27.26) with a difference of -1.87 (5.49,1.76). There was good repeatability of FAS, SF-36, SF-6D and KSQ in free living people with sarcoidosis associated fatigue. Fatigue, general and disease specific health related quality of life showed no significant change over a 12 week period. Studies identifying changes in these outcomes can confidently report a true change and not measurement error or regression to the mean.

Impact of definitive surgery for Graves’ disease on adolescent disease-specific quality of life and psychosocial functioning

Impact of definitive surgery for Graves’ disease on adolescent disease-specific quality of life and psychosocial functioning

Adaptation and validation of the PAC-19QoL-specific quality of life questionnaire for the Spanish population with long COVID

Introduction The post-acute (long) COVID-19 Quality of Life instrument is the only specific instrument designed to assess the quality of life in long COVID patients. The present study aims to make a transcultural adaptation and validation into Spanish of the disease-specific (long COVID) quality of life instrument, post-acute (long) COVID-19 Quality of Life, to have a tool for objective measurement of quality of life in this population. Methods A descriptive cross-sectional study was divided into two phases. In phase one, the translation and cultural adaptation of the questionnaire was performed, while in phase two, the questionnaire was validated. The Spanish version of the questionnaire was used with a sample of 206 people, 40 males (19.4%) and 166 females (80.6%), with an age range between 21 and 70 years old. Participants completed the questionnaire through an online platform. Internal consistency, construct validity, convergent validity, test-retest reliability, and ceiling and floor effects of the Spanish version were analyzed. Results The Spanish version of the post-acute (long) COVID-19 Quality of Life instrument showed high internal consistency, with Cronbach's alpha= 0.922 and an intraclass correlation coefficient of 0.936. Mean scores obtained in the PAC-19QoL and SF-12 questionnaires showed that those who had a worse quality of life in the SF-12 tool also a had worse quality of life in the PAC-19QoL tool. Conclusions This study shows that the Spanish version of the post-acute (long) COVID-19 Quality of Life instrument is an appropriate and valid tool for assessing the quality of life of long COVID patients.

Health-related quality of life aspects of the 'Periodontitis prevalence in ulcerative colitis and Crohn's disease' (PPCC) cohort.

To assess whether oral health problems affect disease-specific quality of life (QoL) of inflammatory bowel disease (IBD) patients, and vice versa, whether IBD affects oral-health-related QoL. Individuals reporting IBD and matched controls were surveyed on general anamnestic information, oral-health-related questions and the Oral Health Impact Profile (OHIP)-5. IBD patients were additionally surveyed on years since diagnosis, disease activity and severity as well as health-related QoL (Short Inflammatory Bowel Disease Questionnaire, sIBDQ). OHIP-5 and sIBDQ were defined as primary outcome parameters, and several predictors and confounders were used in adjusted univariable and multivariable regression analyses. Answers from 1108 IBD patients and 3429 controls were analysed. Compared with controls, IBD patients reported significantly more frequently an oral impact on daily life and worse oral-health-related QoL, with Crohn's disease (CD) patients being more severely affected than ulcerative colitis (UC) patients. The diagnosis of UC and CD, having <20 teeth, severe periodontitis and stressful daily-life experience were associated with a higher prevalence of poor oral-health-related QoL. Among IBD patients, an impaired IBD-specific, health-related QoL was significantly associated with the diagnosis of CD and depression, IBD activity and severity, having <20 teeth, presence of oral lesions and stressful daily-life experience, while a longer time since diagnosis was significantly associated with an improved IBD-specific, health-related QoL. The results of the present study indicate, for the first time, that oral health problems are associated with an impairment of IBD-specific health-related QoL, and vice versa, IBD is associated with an impaired oral health-related QoL. This emphasizes the potential advantages of including dental professionals in the multi-disciplinary treatment teams of IBD patients.

Validity and reliability of the adapted Dutch version of the Brace Questionnaire (BrQ).

The Brace Questionnaire (BrQ) is a disease-specific health-related quality of life (HRQOL) instrument for measuring perceived health status of scoliosis patients undergoing brace treatment. The purpose of this study is to evaluate the validity and reliability of a translated and culturally adapted Dutch version of the BrQ. The original Greek BrQ was translated into Dutch and a cross-cultural adaptation and validation processes were conducted. Subsequently, 80 adolescent idiopathic scoliosis (AIS) patients undergoing active brace treatment were included from 4 scoliosis centers to evaluate the validity and reliability of the Dutch version of the BrQ. The questionnaire's floor and ceiling effects, internal consistency, and test-retest reliability were assessed. Concurrent validity was evaluated by comparing the BrQ with the revised Scoliosis Research Society 22-item questionnaire (SRS-22r) scores. The mean total BrQ score was 75.9 (standard deviation [SD] 11.3) and the mean domain scores varied between 3.4 (SD 0.9) and 4.2 (SD 0.7) for the domains "vitality" and "bodily pain," respectively. There were no floor and ceiling effects for the total BrQ score. The BrQ showed satisfactory internal consistency in most subdomains with a Cronbach's α ranging between 0.35 for the domain "general health perception" and 0.89 for the domain "self-esteem and aesthetics." Excellent test-retest reproducibility was observed for the total BrQ score (ICC 0.91), and the BrQ was successfully validated against the SRS-22r. The translated and culturally adapted Dutch version of the BrQ is a valid and reliable HRQOL instrument for AIS patients undergoing brace treatment.

Functional capacity and dyspnea during follow-up after acute pulmonary embolism

BackgroundDissecting the determinants of functional capacity during long-term follow-up after acute pulmonary embolism (PE) can help to better characterize a patient population with persisting limitation. MethodsIn a prospective cohort study, consecutive unselected survivors of acute PE underwent 3- and 12-month follow-up, including six-minute walking distance (6MWD) and dyspnea assessment with the modified Medical Research Council (mMRC) scale. We used reference equations adjusting for age, sex, and anthropometric measurements to define abnormal 6MWD. ResultsOverall, 323 of 363 (89.0%) patients had at least one recorded 6MWD value at one year. At 3 months, the prevalence of abnormal 6MWD was 21.9% and at 12 months it was 18.3%. At 3 and 12 months, 58.8% and 52.1% with abnormal 6MWD did not report dyspnea, respectively. On average and during follow-up, 6MWD significantly improved with time, while the mMRC dyspnea scale did not. Abnormal 6MWD was associated with younger age (odds ratio per decade, 0.91; 95% CI, 0.88-0.94), higher body mass index (1.10; 1.03-1.17), smoking (3.53; 1.34-9.31), intermediate- or high-risk PE (3.21; 1.21-8.56), and higher mMRC grading (2.28; 1.59-3.27). Abnormal 6MWD at 3 months was associated with the prospectively defined endpoint of post-PE impairment (3.72; 1.50-9.28) and with poor disease-specific and generic health-related quality of life. ConclusionThree months after PE, 37% of patients reported dyspnea and 22% had abnormal 6MWD. After a year, 20% still had abnormal 6MWD. Dyspnea correlated with abnormal 6MWD, but over 50% of patients with abnormal 6MWD did not report dyspnea. Abnormal 6MWD predicted subsequent post-pulmonary embolism impairment and worse long-term quality of life. Clinical Trial RegistrationGerman Clinical Trials Register Identifier DRKS00005939.

Chronic hand eczema: A prevalent disease in the general population associated with reduced quality of life and poor overall health measures.

The impact of hand eczema (HE) on Health-Related Quality of Life (HRQoL) has only been sparsely studied in a general population setting, and never by use of the disease specific Quality Of Life in Hand eczema Questionnaire (QOLHEQ). To examine the HRQoL of unselected individuals with HE using the QOLHEQ. Further, to provide prevalence estimates of severe and chronic HE (CHE), and to contrast overall health related outcomes between individuals with and without HE. In this nationwide, cross-sectional study a questionnaire covering questions on HE related outcomes, and overall health was sent to a random sample of 100 000 Danish adults via a secure digital mailbox, linked to their unique civil registration numbers. Data on demographic characteristics were retrieved from the civil registration system. Individuals reporting HE, further answered the QOLHEQ and other disease specific questions. The response rate was 42.7% (n = 42 691). Total estimates of lifetime, 1-year and point prevalences of HE were 24.4%, 13.3% and 5.8%. Of individuals reporting a 1-year prevalence, 35.1% reported moderate-severe disease and 82.6% CHE. Individuals with HE were more likely to report less good or poor overall health, and sick leave (any reason), compared to those without. In the 2176 (92.5%) with current HE who completed the QOLHEQ, median QOLHEQ scores corresponded to a moderate impairment of the symptoms and treatment and prevention domains and a slight impairment overall and for the emotions and functioning domains. Factors that were strongly associated with moderate to severe HRQoL impairment included severe, chronic and occupational HE as well as female sex. HE is highly prevalent, bears a considerable burden on society and significantly affects the lives of impacted individuals. Our findings indicate a necessity for targeted prevention aimed at high-risk groups, and support and treatment for those most affected.

Mid-term Outcomes of Nissen Fundoplication Versus Roux-en-y Gastric Bypass for Primary Management of Gastroesophageal Reflux Disease in Patients With Obesity.

The efficacy and outcomes of laparoscopic Nissen fundoplication (LNF) in patients with obesity is controversial. Specifically, concerns regarding long-term outcomes and recurrence in the setting of obesity has led to interest in laparoscopic Roux-en-Y gastric bypass (RYGB). In this retrospective cohort study, we studied patients with obesity who underwent either LNF or RYGB for gastroesophageal reflux disease. Baseline demographics, clinical variables, operative outcomes, and symptom severity scores were compared. Baseline demographics, operative outcomes, and quality-of-life scores were similar. Proton pump inhibitor usage, quality-of-life, symptom severity scores, and satisfaction with the operation were similar between groups at mid-term follow-up. RYGB and LNF produced similar improvements in disease-specific quality of life with similar rates of complications, side effects, and need for reoperation. This demonstrates that RYGB and LNF represent possible options for surgical management of gastroesophageal reflux disease in obese patients.

Development and validation of a disease-specific quality of life measure QLICD-HY (V2.0) for patients with hypertension

The purpose of the present study is to develop and validate the hypertension scale of the Quality of Life Instruments (QoL) for Chronic Diseases system, QLICD-HY (V2.0). The QLICD-HY (V2.0) was developed via a programmed decision method with several focus groups, nominal discussions and pilot testing. The data was collected from 370 hypertensive inpatients and measured their QoL three times before and after treatment. Using correlation, factor analyses, as well as t-tests, the psychometric properties of the scale were assessed with regard to validity, reliability and responsiveness. Correlation and factor analysis supported good construct validity and criterion-related validity when using Short Form 36 as a criterion. Test–retest reliability coefficients for the overall scale score and all domains, with the exception of the psychological and social domain (0.77, 0.78), were greater than 0.80, with a range of 0.77–0.92. The internal consistency for all domains was higher than 0.70. With the exception of the psychological domain and social domain, the overall score and scores for the majority of aspects within each domain underwent statistically significant changes (t-tests) after the treatment. The QLICD-HY (V2.0) has good validity, reliability and responsiveness and can be used as a QoL measure for hypertensive patients.

Validation of the German language version of the Chronic Ear Survey and its psychometric comparison with an established German language measurement instrument. German version

With the Chronic Ear Survey (CES), avalidated measurement instrument for the assessment of disease-specific health-related quality of life (HRQoL) has been available internationally since 2000. The aim of this study was to provide avalidated German version of this international instrument and to compare it with the German Chronic Otitis Media Outcome Test15 (COMOT-15). The CES was translated into German via aforward-backward translation process. For validation, 79patients with COM undergoing middle ear surgery were prospectively included. HRQoL was determined preoperatively and 6months postoperatively using the CES and the COMOT-15. Pure tone audiometry was also performed at both measurement time points. In the control examination, an additional retrospective assessment of the preoperative situation was additionally performed using the CES and the COMOT-15 to assess the response shift. The determined psychometric characteristics were internal consistency, test-retest reliability, discrimination validity, agreement validity, responsiveness, and response shift for both measurement instruments. Convergent validity of both measurement instruments was assessed using linear regression. On the basis of the CES, patients with COM could be reliably distinguished from patients with healthy ears. The CES showed satisfactory reliability with high internal consistency (Cronbachα 0.65-0.85) and high retest reliability (r > 0.8). The global assessment of HRQoL impairment correlated very well with the scores of the CES (r = 0.51). In addition, it showed ahigh sensitivity to change (standardized response mean -0.86). Compared to the COMOT-15, it showed alower response shift (effect size -0.17 vs. 0.44). Both measurement instruments correlated only slightly with air conduction hearing threshold (r = 0.29 and r = 0.24, respectively). The concordant validity of both measurement instruments was high (r = 0.68). The German version of the CES shows satisfactory psychometric characteristics, so that its use can be recommended. The CES focuses on the influence of ear symptoms on HRQoL, whereas the COMOT-15 also includes functional and psychological aspects. Due to only minor response shift effects, the CES is particularly suitable for studies with multiple repeat measurements.

Assessment of Correlation Between Disease Specific Quality of Life and Endoscopy Score After 1Month and 6Months of Endoscopic Sinus Surgery (ESS) in Patients with Chronic Rhinosinusitis: A Prospective Study.

Rhinosinusitis is a prevalent condition worldwide affecting the developed and the third world countries alike. SNOT-22 is a validated disease-specific questionnaire designed to use in Chronic Rhino Sinusitis (CRS), which means to quantify patients perception of their disease burden. SNOT 22 questionnaire can chart patients nasal as well as psychological symptoms arising due to CRS and very well become marker of individual symptomatic improvement. To study the correlation between disease specific quality of life and endoscopy score after 1month and 6months of Endoscopic Sinus Surgery in patients with Chronic Rhinosinusitis. In the present study, ESS surgery showed improvement in Endoscopy score and all the symptoms assessed by SNOT-22. The total percentage of improvement in the SNOT-22 score was 70% after 1month and 89% at the end of 6months. We conclude that after the procedure of ESS not only endoscopic evaluation is necessary but also psychological and symptomatic assessment by SNOT 22 is very necessary as nasal and psychological factors were equally decisive for the seeking of the treatment (pharmacological/surgical) by the patient.

Cross-Cultural Participation in Food-Related Activities and Quality of Life among Children with Celiac Disease.

Children with celiac disease may face challenges in managing a gluten-free diet during their daily interactions and activities. The objective of this study was to compare how children with celiac disease manage their gluten-free diet and participate in food-related activities in Italy and Israel and to assess their quality of life. The previously validated Children's Activities Report (CD-Chart) and the Disease-specific Health-Related Quality of Life Questionnaire for Children with Celiac Disease (CDDUX) were administered in Italy to children aged 8-16 diagnosed with CD (n = 39). The results were compared to data that had been previously gathered from Israeli children with CD (n = 106). The CD-Chart demonstrated satisfactory internal reliability within each cultural group (Italy: α = 0.82; Israel: α = 0.76). Mann-Whitney U-tests indicated significant differences between the two groups. The Italian children exhibited a significantly higher preference for participating in the activities compared to the Israelis (U = 3283.50, p < 0.001). Nonetheless, the Italian children displayed a notable decrease in their level of involvement in the preparation required before engaging in different activities (U = 760.50, p < 0.001). Moreover, they exhibited significantly lower self-determination in this preparatory process compared to the Israeli children (U = 726.00, p < 0.001). Significant group differences were found between the CDDUX children's self-reports and parents' proxy reports in the Israeli group but not in the Italian group. The CD-Chart revealed both shared and distinct participation characteristics in daily food-related activities across different cultural contexts. By incorporating the CD-Chart and the CDDUX, healthcare professionals can emphasize crucial aspects of day-to-day health management and guide them in establishing suitable intervention objectives to enhance effective health self-management.

Quality of Life after Brain Injury in Children and Adolescents (QOLIBRI-KID/ADO)-The First Disease-Specific Self-Report Questionnaire after Traumatic Brain Injury.

The subjective impact of the consequences of pediatric traumatic brain injury (pTBI) on different life dimensions should be assessed multidimensionally and as sensitively as possible using a disease-specific health-related quality of life (HRQoL) instrument. The development and psychometrics of the first such self-report questionnaire for children and adolescents after TBI are reported here. Focus group interviews with children, adolescents, and their parents, cognitive debriefing, item pool generation and reduction using Delphi expert panels were performed. The resulting version was psychometrically tested on 300 individuals aged 8-17 years. After item reduction based on factor analyses, differential item functioning, reliability, and validity were investigated. The final 35 items were associated with six scales (Cognition, Self, Daily Life and Autonomy, Social Relationships, Emotions, Physical Problems). Internal consistency and construct validity were satisfactory. Health-related Quality of life (HRQoL) was significantly lower in older and in female participants, as well as those with cognitive disabilities, anxiety, depression and post-concussion symptoms, than in comparative groups. The new QOLIBRI-KID/ADO is a comprehensive, multidimensional, reliable, and valid instrument, comparable in content and items to the QOLIBRI adult version. Therefore, disease-specific HRQoL can now be measured across the lifespan and may support the amelioration of treatment, care, rehabilitation, and daily life of children and adolescents after TBI.

Fatigue and Physical Activity Patterns in Children With Inflammatory Bowel Disease.

Fatigue is a common symptom in children with inflammatory bowel disease (IBD). Diagnostic tests to evaluate biological causes of fatigue commonly include markers of inflammation and hemoglobin (Hb), yet functional parameters have been inadequately studied in pediatric IBD. In this study, we compared fatigued and non-fatigued children with IBD from both a biological and functional point of view. A cross-sectional study of 104 pediatric IBD patients with mild to moderately active IBD was conducted. Fatigued children were defined as those with a Pediatric Quality of Life Inventory Multidimensional Fatigue Scale z score <-2.0. Non-fatigued children had a z score ≥-2.0. Disease-specific quality of life (measured with IMPACT-III score), C-reactive protein (CRP), fecal calprotectin (FC), hemoglobin z score (Hb z score), and physical activity tests including 6-minute walking distance z score (6MWD z score) and triaxial accelerometry (TA) were evaluated. Fatigued children (n = 24) had a significant lower IMPACT-III score than non-fatigued children (n = 80). Hb z scores, CRP, FC, and 6MWD z scores were not significantly different between groups. TA was performed in 71 patients. Wear time validation requirements were met in only 31 patients. Fatigued patients spent significant shorter median time in moderate-to-vigorous activity than non-fatigued patients (18.3 vs 37.3 minutes per day, P = 0.008). Biological parameters did not discriminate fatigued from non-fatigued patients. TA possibly distinguishes fatigued from non-fatigued patients; the potential association may provide a target for interventions to combat fatigue and improve quality of life.

Effect of Fecal Microbiota, Live-Jslm (REBYOTA [RBL]) on Health-Related Quality of Life in Patients With Recurrent Clostridioides difficile Infection: Results From the PUNCH CD3 Clinical Trial.

Recurrence of Clostridioides difficile infection (rCDI) is common, prolonging disease morbidity and leading to poor quality of life. We evaluated disease-specific health-related quality of life (HRQL) in patients with rCDI treated with fecal microbiota, live-jslm (REBYOTA [RBL]; Rebiotix) versus placebo. This was a secondary analysis of a randomized, double-blind, placebo-controlled phase 3 study (PUNCH CD3). The disease-specific Clostridioides difficile Quality of Life Survey (Cdiff32) was administered at baseline and at weeks 1, 4, and 8. Changes in Cdiff32 total and domain (physical, mental, social) scores from baseline to week 8 were compared between RBL and placebo and for responders and nonresponders. Findings were analyzed in a total of 185 patients (RBL, n = 128 [69.2%]; placebo, n = 57 [30.8%]) with available Cdiff32 data. Patients from both arms showed significant improvements in Cdiff32 scores relative to baseline across all outcomes and at all time points (all P < .001); RBL-treated patients showed significantly greater improvements in mental domain than those receiving placebo. In adjusted analyses, RBL-treated patients showed greater improvements than placebo in total score and physical and mental domains (all P < .05). Similar improvement in mental domain was observed among responders, while nonresponders showed numerical improvements with RBL but not placebo. In a phase 3 double-blinded clinical trial, RBL-treated patients reported more substantial and sustained disease-specific HRQL improvements than placebo-treated patients. ClinicalTrials.gov NCT03244644 (https://clinicaltrials.gov/ct2/show/NCT03244644).

Homoeopathy in Psoriasis Vulgaris with Special Emphasis on Modified Naranjo Criteria for Homeopathy: An Evidence-Based Case Report

Abstract Background Psoriasis is a chronic multisystem inflammatory disease with predominantly skin and joint involvement. Ample evidences suggest that psoriasis patients improve under homoeopathic treatment. The main objective of this documentation is to find out whether such improvement can be attributable to the homoeopathic treatment. Method A case of psoriasis vulgaris with the complaint of dry, scaly itching eruption on the extensor surface of both legs is presented here. Outcome-related to impact on daily living (ORIDL) was used to evaluate the patient-reported outcome related to his daily living, disease severity in the involved area was assessed by PASI (Psoriasis Area and Severity Index) scale and PDI (Psoriasis Disability Index) scale was used to assess the disease-specific quality of life. Photographs were taken as objective evidence after obtaining consent from the patient. The Modified Naranjo Criteria for Homeopathy (MONARCH) was used to find out the possible causal attribution of the treatment provided. Result The ORIDL score of (+4) showed the major improvement from patient and physician's perspective. PASI score reduced from ‘11.2 to 0’ (documented in photographs) within a plausible timeframe. The duration of remission of the skin lesion continued for six months. Each domain of PDI score reduced (from ‘25 to 3′) imparting improved quality of life. The high total score (+9 in ‘−6 to 13’ scale) of MONARCH suggested the likelihood of improvement was attributable to the homoeopathic intervention. This case has evidently shown its marked improvement with validated outcome measures.

Impact of time-to-surgery on survival and quality of life in oral cancer

PurposeTo investigate the association between time-to-surgery (TTS) and overall survival (OS), disease specific survival (DSS) and quality of life (QoL) in patients with oral squamous cell carcinoma (OSCC). Materials and methods116 patients with OSCC candidate to surgery were examined. TTS intervals starting from diagnosis (TTS-clinical-based) and from histological reports (TTS-biopsy-based) were calculated. The effects of TTS intervals and prognostic factors on 5-year OS and DSS were explored. ResultsIn our cohort advanced T-categories OSCCs with TTS < 30 days showed a trend to have higher DSS rate (p = 0.049). Patients with TTS-clinical-based < 30 days showed better postoperative QoL. Positive surgical margins, nodal involvement (pN+), DOI >10 mm, invasive surgery and extra-capsular extension in pN+ were found to be significantly associated with a poor OS and DSS. ConclusionsTTS ≥ 30 days can adversely affect DSS, especially in the advanced T categories. Short TTS intervals resulted associated with a better postoperative QoL.