Disease-specific Questionnaire Research Articles

Validation of the English version of the arrhythmia-specific questionnaire in tachycardia and arrhythmia (ASTA): a Rasch evaluation study

BackgroundPatient-reported outcome measures are important in person-centered care, providing valuable information about patients’ experiences. Disease-specific questionnaires add important information about a certain disease in comparison to generic questionnaires. Questionnaires need to be validated in the targeted population to achieve reliable data. The purpose with the study was to use Rasch measurement theory to evaluate the English version of the ASTA questionnaire.MethodsThe Rasch model theory was used to evaluate global and item fit, targeting, response category functioning, local independency, unidimensionality, differential item functioning (DIF) for gender and age, and reliability.ResultsThe study included 202 patients undergoing DC conversion or catheter ablation at the Centre for Heart Rhythm Disorders at the University of Adelaide, Australia. The mean age was 67 years and 30% were women. Most patients had atrial fibrillation (n = 179), others had atrial flutter or had a combination. One of nine items demonstrated unsatisfactory model fit in the ASTA Symptom scale and two of 13 in the ASTA Health-Related Quality of Life (HRQoL) scale. Unidimensionality was supported for both scales. The targeting was acceptable except for the lower end of the scales. Both scales showed reversed thresholds for the response categories “quite a lot” and “a lot” (eight of ASTA symptoms and 12 of ASTA HRQoL items). Some problems with local dependency were detected in both scales. The reliability (person separation index) was satisfactory: 0.75 for the ASTA symptom scale and 0.77 for the ASTA HRQoL scale. No DIF for gender and age were detected.ConclusionsThe English version of the ASTA questionnaire demonstrated satisfactory measurement properties according to the Rasch model. However, it needs to be evaluated in patients with other arrhythmias. The response categories should be considered as well as DIF in further validation. The ASTA questionnaire can be used for assessments of symptoms and HRQoL between groups of different ages and genders in patients with arrhythmia.

Analysis of lumbar spine stenosis specimens for identification of amyloid.

Lumbar spinal stenosis (LSS) is a common reason for spine surgery in which ligamentum flavum is resected. Transthyretin (TTR) amyloid is an often unrecognized and potentially modifiable mechanism for LSS that can also cause TTR cardiac amyloidosis. Accordingly, older adult patients undergoing lumbar spine (LS) surgery were evaluated for amyloid and if present, the precursor protein, as well as comprehensive characterization of the clinical phenotype. A prospective, cohort study in 2 academic medical centers enrolled 47 subjects (age 69 ± 7 years, 53% male) undergoing clinically indicated LS decompression. The presence of amyloid was evaluated by Congo Red staining and in those with amyloid, precursor protein was determined by laser capture microdissection coupled to mass spectrometry (LCM-MS). The phenotype was assessed by disease-specific questionnaires (Swiss Spinal Stenosis Questionnaire and Kansas City Cardiomyopathy Questionnaire) and the 36-question short-form health survey, as well as biochemical measures (TTR, retinol-binding protein, and TTR stability). Cardiac testing included technetium-99m-pyrophosphate scintigraphy, electrocardiograms, echocardiograms, and cardiac biomarkers as well as measures of functional capacity. Amyloid was detected in 16 samples (34% of participants) and was more common in those aged ≥ 75 years of age (66.7%) compared with those <75 years (22.3%, p < 0.05). LCM-MS demonstrated TTR as the precursor protein in 62.5% of participants with amyloid while 37.5% had an indeterminant type of amyloid. Demographic, clinical, quality-of-life measures, electrocardiographic, echocardiographic, and biochemical measures did not differ between those with and without amyloid. Among those with TTR amyloid (n=10), one subject had cardiac involvement by scintigraphy. Amyloid is detected in more than a third of older adults undergoing LSS. Amyloid is more common with advancing age and is particularly common in those >75 years old. No demographic, clinical, biochemical, or cardiac parameter distinguished those with and without amyloid. In more than half of subjects with LS amyloid, the precursor protein was TTR indicating the importance of pathological assessment.

Validation of a Health-Related Quality of Life Questionnaire in Patients With Recurrent Clostridioides difficile Infection in ECOSPOR III, a Phase 3 Randomized Trial.

Debilitating symptoms of recurrent Clostridioides difficile infection (rCDI) often lead to long-term effects on health-related quality-of-life (HRQOL). In ECOSPOR III, SER-109, an investigational oral microbiome therapeutic, was superior to placebo in reducing rCDI. We investigated the validity, reliability, and responsiveness of a 32-item, CDI-specific questionnaire-the Clostridium difficile Quality of Life Survey (Cdiff32)-across mental, physical, and social domains in patients with rCDI. In this post hoc analysis of a phase 3 clinical trial, 182 outpatients with rCDI completed Cdiff32 and EQ-5D at baseline and at 1 and 8 weeks. Cdiff32 was evaluated for item performance, internal reliability, and convergent validity. To assess known-groups validity, Cdiff32 scores were compared by disease recurrence status at week 1; internal responsiveness was evaluated in the nonrecurrent disease group by 8 weeks by means of paired t test. All 182 patients (mean age [standard deviation], 65.5 [16.5] years; 59.9% female) completed baseline Cdiff32. Confirmatory factor analysis identified 3 domains (physical, mental, and social relationships) with good item fit. High internal reliability was demonstrated (Cronbach α = 0.94 with all subscales >0.80). Convergent validity was evidenced by significant correlations between Cdiff32 subscales and EQ-5D (r = 0.29-0.37; P < .001). Cdiff32 differentiated patients by disease recurrence status at week 1 (effect sizes, 0.38-0.42; P < .05 overall), with significant improvement from baseline through week 8 in patients with nonrecurrent disease at week 1 (effect sizes, 0.75-1.02; P < .001 overall). Cdiff32 is a valid, reliable, and responsive disease-specific HRQOL questionnaire that is fit for purpose for interventional treatment trials. The significant improvement in patients with nonrecurrent disease by 8 weeks demonstrates the negative impact of rCDI on HRQOL.

Estimating the association between physical activity and health-related quality of life in individuals with multiple sclerosis

BackgroundHigher levels of total physical activity (PA) are associated with better health-related quality of life (HRQOL) in individuals with multiple sclerosis (MS). The benefits of PA across the activity continuum have not been well-studied. The goal of this study was to compare the associations between total PA, strenuous PA, moderate PA, and mild PA and HRQOL in a large cohort of individuals with MS using both generic and neurologic disease-specific questionnaires. Longitudinal changes in PA and HRQOL over two years were also examined MethodsSubjects enrolled in SysteMS completed the Godin Leisure Time Exercise Questionnaire (GLTEQ) to measure PA. Subjects also completed generic (SF-36) and neurologic disease-specific (NeuroQoL) HRQOL measures. GLTEQ and HRQOL measures were administered at baseline and 24 months. The associations between the GLTEQ total leisure activity (TLA), strenuous PA, moderate PA and mild PA and scores on NeuroQoL and SF-36 were estimated using Spearman's correlation coefficient and partial Spearman's correlation coefficient adjusting for age, sex and Expanded Disability Status Scale (EDSS) measured by a provider. To further investigate the associations between mild PA and HRQOL measures, the associations between mild PA and HRQOL were estimated in participants who reported no moderate or strenuous PA in the last week. The changes in GLTEQ TLA scores and each component score were compared to the changes in NeuroQoL and SF-36 over 24 months using Spearman's correlation coefficient and partial Spearman's correlation coefficient adjusting for age, sex and EDSS. ResultsStatistically significant weak correlations were observed between GLTEQ TLA and NeuroQoL and SF-36 domains, with higher levels of TLA being associated with better HRQOL outcomes. After adjusting for age, sex and EDSS, all correlations were attenuated. Strenuous and moderate levels of PA were similarly associated with many HRQOL outcomes, but mild PA was only weakly correlated with NeuroQoL Lower Extremity Function. There was limited change in PA over 24 months. In a subgroup of participants who reported mild PA, but no moderate or strenuous PA, there were no significant associations with NeuroQoL or SF-36 domains at baseline, but increases in mild PA over two years were moderately associated with improvement on NeuroQoL Upper Extremity Function and SF-36 Mental Health and Mental Component Summary. ConclusionThere were weak associations between TLA and HRQOL across a wide range of HRQOL variables. In addition, both strenuous PA and moderate PA were weakly associated with many HRQOL outcomes, but mild PA was only associated with lower extremity function. Increases in mild PA in a subgroup of individuals who reported no strenuous or moderate PA at baseline were associated with improvements in HRQOL at 24 months. These findings suggest that programs aimed at increasing PA across the activity continuum may lead to improvements in multiple areas of HRQOL in individuals with MS.

A comparison of patient-reported outcome measures for dupuytren disease: A prospective view

Treatment success in Dupuytren´s disease has traditionally been assessed by clinical examination and physical measures, but based on patient orientation, patient-reported outcome measures (PROMs) can be used to quantify treatment impacts and health-related quality of life. The aim of this study was to compare the most widely used PROMS in Dupuytren´s disease, their psychometric properties, and their association with objectively measured hand function. We show a prospective study in which two disease-specific questionnaires (URAM scale and SDSS) and two hand-specific questionnaires (briefMHQ and PEM) were administered before and a month after the treatment with collagenase. Psychometric properties (construct validity, internal consistency, test-retest reliability, internal and external responsiveness, reliability, and minimal clinically important difference (MCID)) were calculated for all the questionnaires. Ninety-two completed both sets of questionnaires. Pre- and post-treatment scores were strongly correlated (Spearman rho >0.6) for all questionnaires. High internal consistency (Cronbach alpha >0.88) was observed for all the questionnaires. Test-retest reliability was also significant, with an ICC of >0.50 in all cases. The MCID was similar for three of the questionnaires (URAM, 11.528/45=0.256; SDSS, 5.079/20=0.254; and PEM, 21.542/77=0.215) and somewhat lower for the briefMHQ (10.617/60=0.177). No correlations were observed between treatment outcome and treated hand (r=0.107; p=0.31), joint (r=0.163; p=0.12), or finger (r=-0.151; p=0.15). In conclusion, we did not find that any one questionnaire performed better than the other in detecting perceived changes in health status among patients with Dupuytren´s disease treated with collagenase.

Development, validation, and implementation of a Short Breast Health Perception Questionnaire

BackgroundHealth status and perception can be assessed by general or disease-specific questionnaires, and disease specific questionnaires are more specific than general questionnaires. Considering the importance of breast health perception (BHP) in women’s lives and the lack of any pertinent questionnaires, we performed this study to develop a valid and reliable short BHP questionnaire (BHPQ); and then used it to assess the participants’ BHP.MethodsWe first designed and developed the instrument and then measured its inter-rater agreement (IRA), content validity including content validity index (I-CVI) and scale content validity index (S-CVI), and reliability (through internal consistency and test–retest). We then evaluated the BHP of eligible women with normal breasts and benign breast disorders who attended our breast clinic.ResultsThe IRA index (78.6%) showed the optimal relevance and clarity of the questionnaire. The content validity was acceptable; with S-CVIs of 87.35 and 84.42 for clarity and relevance, respectively. The internal reliability was high (Cronbach’s alpha = 0.93). Three questions were eliminated for internal consistency (intraclass correlation coefficient < 0.7) but the rest of the questions showed good and excellent reliability. In the next step, BHP in the 350 eligible participants showed an overall score of 43.89 ± 9.09.ConclusionThis study introduces a valid and reliable 11-item BHPQ. We propose its use in various circumstances throughout breast cancer screening, diagnosis, and treatment; and in the assessment of BHP in various physiologic and reproductive situations.

0788 The effect of CPAP on quality of life in females with mild OSA: Post hoc analysis from the MERGE Randomised Trial

Abstract Introduction The MERGE trial was a multi-centre, randomised, parallel study that showed the beneficial effect of continuous positive airway pressure (CPAP) on quality-of-life in patients with mild obstructive sleep apnea (OSA) (Wimms et al. 2019); findings that have extended the new NICE guidance [Obstructive sleep apnoea/ hypopnoea syndrome and obesity hypoventilation syndrome in over 16s (NG202)].This post-hoc analysis aimed to determine whether differences between the sexes in symptoms and treatment response exist at the mild end of the OSA disease spectrum. Methods Patients were recruited (Nov 2016 - Feb 2019) to receive either CPAP plus standard care, or standard care alone. Mild OSA was defined as: apnea-hypopnea index (AHI) &amp;gt;5 to ≤15 events/hr. Symptoms and quality-of-life were measured by a range of generic and disease specific questionnaires at baseline and 3 months post CPAP commencement. Results 233 participants (30% female) were included in this analysis. Females were on average older (mean ± SD) (51.9±10.4 vs 49.8±12.2 years) with higher BMI (32.2±5.0 vs 29.4±3.7 kg/m2) and had a lower AHI than males (median(IQR)) (9.60(6.50 -12.40) vs 10.30(7.10-13.20) events/hour).Females were sleepier (Epworth Sleepiness Score (ESS) (mean ± SD) (11.0±4.2 vs 9.5±4.4)), more fatigued (Fatigue Severity Score (FSS) (42±12.8 vs. 34.4±13.5)) and reported higher levels of anxiety, depression and insomnia. Reported quality-of-life was lower in the SF- 36 mental (41.8±13 vs. 47.3±10.9) and physical components (43.0±11.2 vs. 49.7±9.1), as well as in all individual domains. Females also reported worse scores in the Euroqol 5 Dimensions (EQ-5D) and Functional Outcomes of Sleep Questionnaire (FOSQ), compared to males.All symptoms improved with CPAP use for both sexes, however female patients had larger improvements in the ESS (mean difference(95%CI)) (-5.2 (-6.7, -3.6) vs (-2.0 (-3.0, -1.0)) p=0.0035, and SF-36 vitality (11.7 (7.9, 15.5) vs 5.6 (3.1, 8.1)) p=0.0092. Conclusion In mild OSA, female patients were more symptomatic and reported worse quality-of-life than males, despite having lower AHIs; all were improved with CPAP treatment. Support (If Any) Funded by ResMed

Mapping Impossible Utilities: The ICER Report on Tezepelumab for Severe Asthma.

The focus of this commentary is on the attempt to create EQ-5D-3L ordinal preferences from a disease specific asthma questionnaire, the Asthma Quality of Life Questionnaire (AQLQ). The question is whether it is possible from the perspective of fundamental measurement to create a simple linear algorithm to map AQLQ scores to EQ-5D-3L preferences. It is proposed that this is mathematically impossible as the aggregate AQLQ score is ordinal, apart from the fact that the AQLQ is a multiattribute score that lacks construct validity and any pretense to having interval properties. Disallowing the mapped utilities means that the modelling cannot be sustained. It is proposed that the focus should be on single attribute measures of the latent construct "need fulfillment quality of life". These measures would meet the required standards of Rasch Measurement Theory (RMT) applying simultaneous conjoint standards of measurement theory, as well as capturing the patient voice.

Adaption of the "Empty Nose 6 Item Questionnaire" (ENS6Q) into German language

The English "Empty-Nose-6-Item-Questionnaire" (ENS6Q) is a validated tool to assess subjective and disease-specific complaints of patients suffering from empty nose syndrome. The aim of this study was to create a validated German adapted version (GAV) of the ENS6Q. The ENS6Q was translated into German language using a multistage process. Subsequently the translated questionnaire was completed twice by a group of patients suffering from empty nose syndrome (n = 36), a healthy control group (n = 77) and a group of patients with a symptomatic pathology of the nasal septum (n = 78). Additionally, the NOSE© questionnaire was completed twice by all groups. The ENS6Q was then examined regarding internal consistency, test-retest reliability, discriminant validity, sensitivity and specificity. The ENS6Q-GAV shows high internal consistency with Cronbachs α = 0,760 and α = 0,795. It also shows good test-retest reliability with an interclass correlation coefficient of 0,947 [0,930 - 0,961]. The ENS6Q-GAV discriminated significantly between empty nose syndrome patients and the control group. The receiver-operating characteristics curve showed a sensitivity of 83,3 % and a specificity of 88,3 % using a cut-off point of 8,5. The area-under-the-curve threshold score was 0,914 ± 0,029 [0,856 - 0,971]. The ENS6Q-GAV is the first validated disease-specific questionnaire in German to help identify patients suspected of developing ENS more reliably.

MO946: Factors Associated With Changes in Health-Related Quality of Life (Hrqol) in A Greek Cohort of Kidney Transplant Recipients: A Prospective Study

Abstract BACKGROUND AND AIMS Kidney transplantation is recognized as the treatment of choice for patients with End Stage Kidney Disease (ESKD). Improvement in short term patient and graft survival of kidney transplant recipients (KTRs), has shifted interest to the long-term outcomes and Health-Related Quality of Life (HRQoL) estimation is closely related. Thus, reliable evaluation of HRQoL with disease-specific questionnaires is of great importance. The aim of our study was to assess prospectively possible changes in HRQoL during follow up period and to identify associated factors that might affect these changes. METHOD We used the Greek version of the translated and adapted by our team disease-specific instrument Kidney Transplant Questionnaire 25 (KTQ-25) and the Greek SF-36 were administered in a cohort of KTRs during their routine visit in the transplant outpatient clinic twice, at study entry and after one year. Sociodemographic and medical information were also collected at both time points. Inclusion criteria were, aged ≥18-year-old, time since transplant ≥1 year, functioning transplant. All participants provided written informed consent. RESULTS A total of 84 KTRs (59 males; mean age 53.5 ± 10.7; mean e-GFR 47.7 ± 15.1 mL/min/1.73 m2; average time since transplantation 55.7 ± 48.3 months) included in the study at the first time point, while 74 KTRs (88.1%) remained for the second assessment (3 died, 4 denied and 4 changed transplant unit). The majority of KTRs were married (73.8%), with children (77.4%), non-smokers (81.6%) and retired (60.7%). The 45.8% had family monthly income ≤ 1000€. In 62%, hemodialysis was the modality before transplantation and 59.52% had received graft from deceased donor. Immunosuppressive treatment was 84.34% corticosteroids, 54.22% Tacrolimus, 40.96% Cyclosporine, 91.75% MMF and 3.61% Azathioprine. The observed SF-36 scores in all dimensions both time-points were similar without significant changes. Also, no significant changes found between the two time-points at all 5 dimensions and total score of the KTQ-25. A multivariate regression analysis for the 5 dimensions of the KTQ-25 at the second time-point was done. Showed that variables significantly associated with Physical Symptoms dimension was age (P = 0.021) directly and Osteoporosis (P = 0.025) inversely. In regression analysis of Fatigue dimension, variables that remained significant were female sex (P = 0.046) and higher serum cholesterols’ levels (P = 0.012). Uncertainty/Fear dimension was significantly worse in KTRs with history of cardiovascular disease (P = 0.032). Appearance dimension was significantly and positively correlated with female sex and negative with age and history of cardiovascular disease (P = 0.018, P = 0.043 and P = 0.041, respectively). No significantly correlation found for Emotions dimension. Total KTQ-25 score was significantly correlated with female sex (P = 0.024), while history of cardiovascular disease had a negative impact on the score (P = 0.013). CONCLUSION In this one-year prospective study of the HRQoL of KTRs, no statistically significant changes were found in the scores of KTQ-25 and SF-36 instruments. Age, sex, osteoporosis, serum cholesterols’ levels and history of cardiovascular disease are some of the factors that might affect prospectively HRQoL of KTRs.

Disease-Specific Vs Non-Specific Questionnaires on Septoplasty Outcomes.

Introduction:Validated questionnaires are a valuable tool in medical practice. The role of septoplasty in improving patients’ non-nasal symptoms and their quality of life is still controversial. The aim of this study was to determine the differences in outcome after septoplasty measured by a disease-specific questionnaire vs a general QoL questionnaire. Materials and Methods:A total of 50 patients underwent septoplasty and completed the SNOT-22 and the SF-36v2 questionnaires preoperatively and at 6 months post-op. Pre-op, post-op and variation for each domain in both questionnaires were calculated and compared with a measure of self-reported health transition (Question 2 of SF-36v2) and with the Minimal important difference (MID) for our sample.Results:SNOT-22 scores significantly improved for each specific question and for the total score. SF-36v2 showed a significant improvement in scores for mental domains (Mental Health, Role Emotional, and Vitality) but less so for the physical domains. MID for our sample was 4.2 points. Patients with variations greater than 4.2 in SNOT-22 total score (74%) revealed significantly better variations in Physical Function, General Health, Social Function and Vitality.Conclusions:Validated questionnaires are a fundamental tool for assessing outcomes of commonly performed surgeries in ENT. Disease-specific questionnaire showed improvement in scores for the majority of patients. The general QoL showed improvement only in Mental Domains. This may suggest that the impact of septoplasty in patient’s general health might not be significant.

Validation of the Penn Acoustic Neuroma Quality of Life (PANQOL) Scale for Hindi-Speaking Patients Recently Diagnosed with Vestibular Schwannoma.

The Penn Acoustic Neuroma Quality-of-Life (PANQOL) scale is a disease specific quality-of-life instrument for vestibular schwannoma, developed in English and subsequently validated in four major languages of the world. No such validated version of PANQOL exists for Hindi-speaking population. To translate and examine the validity of the PANQOL scale in a sample of Hindi-speaking patients recently diagnosed with vestibular schwannoma. A cross-sectional study was done at a corporate tertiary care hospital. The PANQOL questionnaire was translated into Hindi by a language expert according to the accepted rules of forward-backward translation. In total, 30 consecutive patients (n = 30) diagnosed with vestibular schwannoma between September 2017 and March 2018 were included in the study. Quality-of-life at the time of diagnosis was measured with the generic Short Form -36 (SF-36) and the disease-specific PANQOL questionnaires. The internal consistency and reliability of the PANQOL domains, as well as the relationship with SF-36 dimensions, were statistically analyzed.The PANQOL scores of the patients in the current study were compared with those of similar such published studies worldwide. Mean age of the patients was 46.3 ΁ 13.25 years. The sex ratio of male to female patients was 19:11. The mean PANQOL total score was 71.6. All its domains had good internal consistency except pain. Most PANQOL domains were correlated with those of the SF-36 dimensions, with the exception of facial dysfunction domain. Good internal consistencies and strong correlations between PANQOL domains and SF-36 dimensions in the current study support the validity of the PANQOL Hindi version.

Association between chronic illness resources and health behaviors in hypertensive stroke patients at 6 months after discharge: a cross-sectional study.

BackgroundThe adoption of appropriate health behaviors can prevent the recurrence of stroke. Previous research found a downward trend in hypertensive stroke patients’ health behaviors from 3 to 6 months after discharge. The provision of appropriate support by chronic illness resources has been shown to predict patients’ engagement in appropriate health behaviors in other chronic illness populations. This study sought to explore the association between chronic illness resources and health behaviors in hypertensive stroke patients in order to provide a foundation for the secondary prevention of stroke.MethodsUsing convenience sampling method, we enrolled 133 hypertensive stroke patients at 6 months after discharge in Guangzhou, China. All the patients completed a demographic and disease-specific questionnaire, the Health Behavior Scale for Stroke Patients (HBS-SP) and the Chronic Illness Resources Survey (CIRS). A multiple stepwise regression analysis was conducted to test the association of chronic illness resources with health behaviors.ResultsThe total scores of the HBS-SP and CIRS were (2.89±0.38) and (2.94±0.66), respectively. The correlation coefficient for chronic illness resources and health behaviors was 0.517 (P<0.001). The positive association between chronic illness resources and health behaviors remained statistically significant after controlling for gender, education level, and the Barthel Index (unstandardized coefficient: 0.317, P<0.001).ConclusionsThe chronic illness resources has positive association with health behaviors in hypertensive stroke patients at 6 months after discharge. A good support provided by chronic illness resources may contribute to promote positive health behaviors, and thus prevent the recurrence of stroke.

Predictors of Quality of Life Six Years after Curative Colorectal Cancer Surgery: Results of the Prospective Multicenter Study.

Background and objectives: Improving early diagnosis and advances in colorectal cancer (CRC) treatment leads to longer survival of these patients. The purpose of this study was to identify the main surgical factors affecting long-term Quality of life (QoL) among colorectal cancer patients after surgery. Materials and Methods: QoL was prospectively evaluated in patients undergoing elective colorectal cancer resection operations in three CRC surgery centers of Lithuania using EORTC generic (QLQC-30) and disease-specific (QLQ-CR29) questionnaires at the time of preoperative admission and 1, 24, and 72 months after surgery. QoL was evaluated among different patient groups, diagnostic and treatment modalities, disease, and postoperative complications. Non-parametric tests and multivariate logistic regression models were used for statistical analysis. Results: Eighty-eight consecutive CRC patients from three institutions were included in the study over a three-month inclusion period, 42 (47.73%) women and 46 (52.27%) men, mean age 64.2 ± 11.5 years. Most tumors were localized in the sigmoid colon and rectum. The largest number of patients had stage III cancer. Twenty-nine patients died—a 6-year survival rate was 67%. 50 of 59 live patients (84.8%) responded to the questionnaire 6 years after their operation. Evaluating changes in quality of life 72 months after surgery with assessments before surgery, both questionnaire responses revealed good long-term CRC surgical treatment results: improved general and functional scale estimates and decreased symptom scale ratings. The multivariate analysis found that age, stoma formation, and rectal cancer were independent risk factors for having worse QoL six years after surgical intervention. Conclusions: Six years after surgery, QoL returns to preoperative levels. Age, stoma formation, adjuvant treatment, and rectal cancer reduce long-term QoL.

Chronic Rhinosinusitis With Nasal Polyps: Quality of Life in the Biologics Era

Chronic rhinosinusitis (CRS) affects up to 12% of the general population and is traditionally divided into two main phenotypic subsets, based on the presence of nasal polyps (CRSwNP) or their absence. It is well-established that many patients with CRSwNP report poor quality of life (QoL), which is further compromised by comorbidities (eg, asthma, bronchiectasis, aspirin-exacerbated respiratory disease). Chronic rhinosinusitis CRS with nasal polyps is managed with a combination of medical therapy and surgical interventions, and biologics are emerging as a promising new treatment option for patients with inadequate response to the standard of care. A range of patient-reported outcome measures have been used to assess QoL for patients with CRSwNP in clinical trials, including disease-specific questionnaires (eg, Sino-Nasal Outcome Test-22) and generic ones (eg, Short Form-36). Significantly impaired QoL has been identified as a criterion for the indication to use biologics in patients with CRSwNP. This review summarizes clinical evidence (2010-2021) on QoL outcomes with currently available treatments for CRSwNP and assesses the improvement in QoL after biologic treatments, especially for patients with comorbidities reported in interventional studies (randomized controlled trials and real-world experience).

Health-Related Quality of Life in Adrenocortical Carcinoma: Development of the Disease-Specific Questionnaire ACC-QOL and Results from the PROFILES Registry.

We aimed to develop a disease-specific adrenocortical carcinoma (ACC) health-related quality of life (HRQoL) questionnaire (ACC-QOL) and assess HRQoL in a population-based cohort of patients with ACC. Development was in line with European Organization for Research and Treatment of Cancer (EORTC) guidelines, though not an EORTC product. In phase I and II, we identified 90 potential HRQoL issues using literature and focus groups, which were reduced to 39 by healthcare professionals. Pilot testing resulted in 28 questions, to be used alongside the EORTC QLQ-C30. In Phase III, 100 patients with ACC were asked to complete the questionnaires twice in the PROFILES registry (3-month interval, respondents: first 67, second 51). Confirmatory factor analysis demonstrated the structural validity of 26 questions with their scale structure (mitotane side-effects, hypercortisolism/hydrocortisone effects, emotional effects). Internal consistency and reliability were good (Cronbach's alpha 0.897, Interclass correlation coefficient 0.860). Responsiveness analysis showed good discriminative ability (AUC 0.788). Patients diagnosed more than 5 years ago reported a good HRQoL compared with the Dutch reference population, but experienced residual fatigue and emotional problems. Patients who underwent recent treatment reported a lower HRQoL and problems in several domains. In conclusion, we developed an ACC-specific HRQoL questionnaire with good psychometric properties.

Effect of Liothyronine Treatment on Quality of Life in Female Hypothyroid Patients With Residual Symptoms on Levothyroxine Therapy: A Randomized Crossover Study.

ObjectiveThe effects of levothyroxine (LT4)/liothyronine (LT3) combination therapy on quality of life (QoL) in hypothyroid patients former on LT4 monotherapy have been disappointing. We therefore wanted to test the effects of LT3 monotherapy on QoL in hypothyroid patients with residual symptoms despite thyroid stimulating hormone (TSH) values within the reference range.DesignFemale hypothyroid patients with residual symptoms on LT4 monotherapy or combination LT4/LT3 therapy received LT3 and LT4 monotherapy, respectively for 12 weeks in a non-blinded randomized crossover study.MethodsFifty-nine patients aged 18-65 years were included. QoL was assessed using one disease-specific questionnaire (ThyPRO) and two generic questionnaires (Fatigue Questionnaire and SF-36) at baseline and at the end of the two treatment periods. Clinical indices of cardiovascular health (resting heart rate and blood pressure), as well as thyroid tests, were assessed at baseline and at the end of the two treatment periods.ResultsAfter 12 weeks of LT3 treatment, 12 of the 13 domains of the ThyPRO questionnaire (physical, mental and social domains) showed significant improvements. The most pronounced improvements were less tiredness (mean -21 ± 26; P<0.0001) and cognitive complaints (mean -20 ± 20; P<0.0001). LT4 monotherapy exerted minor effects on two domains only (cognitive complaints and impaired daily life). All three dimensions’ scores in the Fatigue Questionnaire (physical, mental and total fatigue) improved after LT3 treatment compared to baseline (P<0.001), and in the SF-36 questionnaire 7 of 8 scales showed significantly better scores after LT3 treatment compared to baseline. There were no differences in blood pressure or resting heart rate between the two treatment groups. TSH in patients on LT3 was slightly higher (median 1.33 mU/L (interquartile range (IQR) 0.47-2.26)) than in patients on LT4 (median 0.61 mU/L (IQR 0.25-1.20; P<0.018). Five patients on LT3 dropped out of the study due to subjectively reported side effects, compared to only one on LT4.ConclusionsLT3 treatment improved QoL in women with residual hypothyroid symptoms on LT4 monotherapy or LT4/LT3 combination therapy. Short-term LT3 treatment did not induce biochemical or clinical hyperthyroidism, and no cardiovascular adverse effects were recorded. Further studies are needed to assess the long-term safety and efficacy of LT3 monotherapy.Clinical Trial Registration ClinicalTrials.gov, identifier NCT03627611.

Quality of life in Indian patients with functional dyspepsia: Translation and validation of the Hindi version of Short-Form Nepean Dyspepsia Index.

Patients with functional dyspepsia (FD) have poor health-related quality of life (HRQOL), but Indian data are lacking. Also, there is non-availability of validated disease-specific questionnaire to assess HRQOL in Hindi-speaking patients withdyspepsia. We aimed to develop and validate a reliable translation of Short-Form Nepean Dyspepsia Index (SF-NDI) in Hindi, and assess the impact of FD on HRQOL in Indian patients. Cross-cultural adaptation of English version of SF-NDI, translation to Hindi, and adaptation of Hindi version were performed using standard procedures. English and Hindi versions were assessed against Short Form-36 (SF-36), examining for internal consistency, test-retest reliability, and validity. Total 211 FD patients (144 Hindi speaking, 67 English speaking) were enrolled (mean age 40.8 ± 11.7years; male:female = 115:96). Median total SF-NDI scores for both languages were 38.75 and 40.0, respectively. Test-retest reliability intraclass correlation coefficients were 0.85 (Hindi) and 0.89 (English). Internal consistency evaluation revealed Cronbach's α coefficient of 0.79-0.86 (Hindi) and 0.78-0.89 (English). SF-NDI sub-scales showed moderate to good correlation with various domains of SF-36 (content validity). There was significant (p &lt; 0.001) decline of HRQOL in patients with severe dyspepsia relative to those with mild dyspepsia (construct validity). On multivariate analysis, factors independently associated with HRQOL were duration of symptoms and dyspepsia severity. Both English and Hindi versions of SF-NDI are reliable and valid for HRQOL assessment in Indian FD patients, and will be useful in future epidemiological and clinical studies. Indian FD patients have poor HRQOL, being worse in those with severe dyspepsia and longer duration of symptoms.

Disease-Specific Outcome Measures Evaluating the Health-Related Quality of Life of Children and Adolescents with Idiopathic Scoliosis and Scheuermann's Kyphosis: A Literature Review

Adolescent idiopathic scoliosis (AIS) and Scheuermann's kyphosis (SK) are the most common types of spinal deformities in adolescents, and both have substantial ramifications on health-related quality of life (HRQoL) parameters. Various questionnaires have been developed to assess HRQoL in age-group populations with spinal deformity. Nevertheless, there remains a lack of consensus across the literature as to which instrument is the most suitable for evaluating the HRQoL of this cohort. Thus, this literature review was conducted to present disease-specific questionnaires for children and adolescents with AIS and SK to provide their psychometric characteristics (validity, reliability, and responsiveness) across different languages. A literature search was performed in the Medline (PubMed), Scopus, EMBASE, and Google Scholar databases. Studies that outlined the development and application of questionnaires evaluating HRQoL of children and adolescents with spinal deformity were included, and data on their validity and reliability in different translated languages were collected. A total of 10 disease-specific questionnaires were identified. Except for one questionnaire that was a proxy-reported measure, the other questionnaires were self-reported. We determined that selecting the proper questionnaire for clinical and research purposes requires careful consideration of various factors including the type of treatment intervention planned as well as various patient demographic factors. For children with early-onset scoliosis, the ideal questionnaire to evaluate their HRQoL is the Early-Onset Scoliosis Questionnaire-24. For adolescents with AIS and SK who are potential candidates for surgical intervention, the use of Scoliosis Research Society-22, Scoliosis Japanese-27, and Quality of Life Profile Spinal Deformity questionnaires is appropriate. For patients who are under nonsurgical treatment, the Brace Questionnaire and Italian Spine Youth Quality of Life questionnaires can be utilized. Nonetheless, when the specific intent of a study is to evaluate the self-image perception of patients, the use of drawing-based questionnaires may be the optimal choice.

Hidden association of knee-related disability with physical activities among community-dwelling older male Saudi Arabians with knee osteoarthritis

Introduction: The impact of knee osteoarthritis (OA) on physical activities of daily life was studied extensively among the elderly across the globe but not well understood in the Saudi Arabian populace with cultural consideration. This paper assessed the association between knee flexion range of motion (ROM) and ritual physical activities among elderly males due to knee OA.Methods: A cross-sectional study with a sample of 139 males aged 56–74 years diagnosed with knee OA recruited at prayer places. The subjective evaluation was carried using a disease-specific Arabic knee physical functional questionnaire Knee injury and OA Outcome Score-Physical Function Short form (KOOS-PS), and the anthropometric measure of knee flexion ROM was objectively measured by a manual goniometer.Results: The mean and standard deviation of the study sample age, height, weight, and body mass index were 66.9 ± 4.09 years, 158.4 ± 6.1 cm, 74.6 ± 7.1 kg, and 29.6 ± 1.9 kg/m2, respectively. The mean, standard deviation and median of the knee flexion ROM and Arabic-KOOS-PS Questionnaire score were 100.7 ± 7.9, 101.5 and 12.9 ± 13.7, 13.4. The non-parametric Spearman correlation coefficient between the knee stiffness and KOOS-PS physical activities resulted very strong positively correlation, r = 0.967.Conclusion: A strong positive correlation has been found between hidden knee disability and ritual physical activities among male cohorts in Saudi cultural community with knee OA