Disease Questionnaire Research Articles

Safinamide as adjunctive therapy to levodopa monotherapy for patients with Parkinson's disease with wearing-off: The Japanese observational J-SILVER study

BackgroundSafinamide is an effective adjunctive therapy for wearing-off in Parkinson's disease (PD); however, evidence is lacking in older patients and those in the early stages of wearing-off. This study evaluated the efficacy and safety of safinamide as adjunctive therapy in patients with PD treated with levodopa monotherapy in clinical practice. MethodsThis multicentre, open-label observational study was conducted at five sites in Japan. Patients diagnosed with PD and wearing-off initiated safinamide as adjunctive therapy with levodopa monotherapy. Efficacy endpoints were mean changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I, III, and IV scores; daily ON-time without dyskinesia using 24-h patient symptom diaries; and 39-item Parkinson's Disease Questionnaire (PDQ-39) scores at 18 weeks of treatment. ResultsIn total, 24 patients initiated safinamide (66.7% were aged ≥75 years); the mean duration of wearing-off was 1.2 years. MDS-UPDRS Part III total score, Part IV total score, and PDQ-39 summary index decreased significantly from baseline (mean change −7.0 [p = 0.012], −2.4 [p = 0.007] and − 5.3 [p = 0.012], respectively). There was a non-statistically significant increase of 1.55 h in mean daily ON-time without dyskinesia. Numerical Rating Scale total score for pain (p = 0.015), and scores for OFF-period pain (p = 0.012) and nocturnal pain (p = 0.021) subdomains were significantly improved in the subgroup with pain. Most reported adverse events were classified as mild. ConclusionSafinamide improved motor and non-motor symptoms and quality of life-related measures in older patients with PD in the early stages of wearing-off without new safety concerns. Study registrationUniversity Hospital Medical Information Network in Japan; study ID: UMIN000044341.

Effect of bimekizumab on patient-reported disease impact in patients with psoriatic arthritis: 1-year results from two phase 3 studies.

To evaluate 1-year bimekizumab efficacy in PsA from the patient perspective using the 12-item PsA Impact of Disease (PsAID-12) questionnaire. BE OPTIMAL (NCT03895203; biologic DMARD [bDMARD]-naïve), BE COMPLETE (NCT03896581; inadequate response/intolerance to TNF inhibitors [TNFi-IR]) and BE VITAL (NCT04009499; open-label extension) assessed bimekizumab 160 mg every 4 weeks in patients with PsA. Post hoc analyses of patient-reported disease impact, assessed by the PsAID-12 questionnaire, are reported to 1 year (collected to Week 40 in BE COMPLETE). Overall, 1,112 total patients were included (698 bimekizumab, 414 placebo). Rapid improvements observed with bimekizumab treatment at Week 4 continued to Week 16 and were sustained to 1 year. At 1 year, mean (SE) change from baseline in PsAID-12 total score was comparable between bimekizumab-randomized patients and patients who switched to bimekizumab at Week 16 (bDMARD-naïve bimekizumab -2.3 [0.1], placebo/bimekizumab -2.2 [0.1]; TNFi-IR bimekizumab -2.5 [0.1], placebo/bimekizumab -2.2 [0.2]). Proportions of bimekizumab-randomized patients achieving clinically meaningful within-patient improvement (≥3-point decrease from baseline) at Week 16 were sustained to 1 year (bDMARD-naïve 49.0%; TNFi-IR 48.5%) and were similar for placebo/bimekizumab patients (bDMARD-naïve 44.4%; TNFi-IR 40.6%). Across studies and arms, 35.3% to 47.8% of patients had minimal or no symptom impact at 1 year. Improvements were observed to 1 year across all single-item domains, including pain, fatigue and skin problems. Bimekizumab treatment resulted in rapid and sustained clinically meaningful improvements in disease impact up to 1 year in bDMARD-naïve and TNFi-IR patients with PsA. BE OPTIMAL: NCT03895203; BE COMPLETE: NCT03896581; BE VITAL: NCT04009499 (ClinicalTrials.gov).

Effects of Mediterranean Diet, Curcumin, and Resveratrol on Mild-to-Moderate Active Ulcerative Colitis: A Multicenter Randomized Clinical Trial.

This study aimed to investigate the effects of the Mediterranean diet (MD), combined with curcumin and resveratrol supplementation, on disease activity, serum inflammatory markers, and quality of life in patients with mild-to-moderate active ulcerative colitis (UC). This study was designed as a prospective multicenter three-arm randomized controlled trial. Participants were randomized to the MD, MD + curcumin, and MD + resveratrol groups. All participants were placed on the MD for 8 weeks. The MD + curcumin group also received 1600 mg/day of curcumin supplementation, whereas the MD + resveratrol group received 500 mg/day of resveratrol supplementation for 8 weeks. Anthropometric measurements, Truelove-Witts Index, Short Form-36, Inflammatory Bowel Disease Questionnaire, Mediterranean Diet Adherence Scale (MEDAS), and laboratory tests were performed at baseline and postintervention. Within-group comparisons showed that MD, MD + curcumin, and MD + resveratrol interventions were effective in reducing disease activity and inflammation and improving quality of life in individuals with UC (p < 0.05). Between-group comparisons revealed no significant difference in all parameters except for the pain subparameter of SF-36 and the MEDAS score (p < 0.05). The MD is an effective and safe intervention to be used in clinical practice in individuals with UC.

Utility of diffusion tensor imaging and generalized q-sampling imaging for predicting short-term clinical effect of deep brain stimulation in Parkinson’s disease

PurposeTo assess whether diffusion tensor imaging (DTI) and generalized q-sampling imaging (GQI) metrics could preoperatively predict the clinical outcome of deep brain stimulation (DBS) in patients with Parkinson’s disease (PD).MethodsIn this single-center retrospective study, from September 2021 to March 2023, preoperative DTI and GQI examinations of 44 patients who underwent DBS surgery, were analyzed. To evaluate motor functions, the Unified Parkinson’s Disease Rating Scale (UPDRS) during on- and off-medication and Parkinson’s Disease Questionnaire-39 (PDQ-39) scales were used before and three months after DBS surgery. The study population was divided into two groups according to the improvement rate of scales: ≥ 50% and < 50%. Five target regions, reported to be affected in PD, were investigated. The parameters having statistically significant difference were subjected to a receiver operating characteristic (ROC) analysis.ResultsQuantitative anisotropy (qa) values from globus pallidus externus, globus pallidus internus (qa_Gpi), and substantia nigra exhibited significant distributional difference between groups in terms of the improvement rate of UPDRS-3 scale during on-medication (p = 0.003, p = 0.0003, and p = 0.0008, respectively). In ROC analysis, the best parameter in predicting DBS response included qa_Gpi with a cut-off value of 0.01370 achieved an area under the ROC curve, accuracy, sensitivity, and specificity of 0.810, 73%, 62.5%, and 85%, respectively. Optimal cut-off values of ≥ 0.01864 and ≤ 0.01162 yielded a sensitivity and specificity of 100%, respectively.ConclusionThe imaging parameters acquired from GQI, particularly qa_Gpi, may have the ability to non-invasively predict the clinical outcome of DBS surgery.

Levodopa-Induced Dyskinesias are Frequent and Impact Quality of Life in Parkinson's Disease: A 5-Year Follow-Up Study.

Levodopa-induced dyskinesias (LID) are frequent in Parkinson's disease (PD). To analyze the change in the frequency of LID over time, identify LID related factors, and characterize how LID impact on patients' quality of life (QoL). PD patients from the 5-year follow-up COPPADIS cohort were included. LID were defined as a non-zero score in the item "Time spent with dyskinesia" of the Unified Parkinson's Disease Rating Scale-part IV (UPDRS-IV). The UPDRS-IV was applied at baseline (V0) and annually for 5 years. The 39-item Parkinson's disease Questionnaire Summary Index (PQ-39SI) was used to asses QoL. The frequency of LID at V0 in 672 PD patients (62.4 ± 8.9 years old; 60.1% males) with a mean disease duration of 5.5 ± 4.3 years was 18.9% (127/672) and increased progressively to 42.6% (185/434) at 5-year follow-up (V5). The frequency of disabling LID, painful LID, and morning dystonia increased from 6.9%, 3.3%, and 10.6% at V0 to 17.3%, 5.5%, and 24% at V5, respectively. Significant independent factors associated with LID (P < 0.05) were a longer disease duration and time under levodopa treatment, a higher dose of levodopa, a lower weight and dose of dopamine agonist, pain severity and the presence of motor fluctuations. LID at V0 (β = 0.073; P = 0.027; R2 = 0.62) and to develop disabling LID at V5 (β = 0.088; P = 0.009; R2 = 0.73) were independently associated with a higher score on the PDQ-39SI. LID are frequent in PD patients. A higher dose of levodopa and lower weight were factors associated to LID. LID significantly impact QoL.

Staged Bilateral MRI-Guided Focused Ultrasound Subthalamotomy for Parkinson Disease

Unilateral magnetic resonance imaging (MRI)-guided focused ultrasound subthalamotomy (FUS-STN) improves cardinal motor features among patients with asymmetrical Parkinson disease (PD). The feasibility of bilateral FUS-STN is as yet unexplored. To assess the safety and effectiveness of staged bilateral FUS-STN to treat PD. This prospective, open-label, case series study was conducted between June 18, 2019, and November 7, 2023, at HM-CINAC, Puerta del Sur University Hospital, Madrid, Spain, and included 6 patients with PD who had been treated with unilateral FUS-STN contralateral to their most affected body side and whose parkinsonism on the untreated side had progressed and was not optimally controlled with medication. Staged bilateral FUS-STN. Primary outcomes were assessed 6 months after the second treatment and included safety (incidence and severity of adverse events after second treatment) and effectiveness in terms of motor change (measured with the Movement Disorders Society Unified Parkinson's Disease Rating Scale part III [MDS-UPDRS III]) in the off-medication state (ie, after at least 12 hours of antiparkinsonian drug withdrawal) compared with baseline (ie, prior to the first side ablation). Secondary outcomes included motor change in patients in the on-medication state (ie, after usual antiparkinsonian medication intake), motor complications (measured with the MDS-UPDRS IV), daily living activities (measured with the MDS-UPDRS I-II), quality of life (measured with the 39-item Parkinson's Disease Questionnaire), change in dopaminergic treatment, patient's global impression of change (measured with the Global Impression of Change [PGI-C] scale), and long-term (24-month) follow-up. Of 45 patients previously treated with unilateral FUS-STN, 7 were lost to follow-up, and 4 were excluded due to adverse events. Of the remaining 34 patients, 6 (median age at first FUS-STN, 52.6 years [IQR, 49.0-57.3 years]; 3 women [50%]) experienced progression of parkinsonism on the untreated body side and were included. At the time of the first FUS-STN, patients' median duration of disease was 5.7 years (IQR, 4.7-7.3 years). The median time between procedures was 3.2 years (IQR, 1.9-3.5 years). After the second FUS-STN, 4 patients presented with contralateral choreic dyskinesia, which resolved by 3 months. Four patients developed speech disturbances, which gradually improved but remained in a mild form for 2 patients at 6 months; 1 patient experienced mild imbalance and dysphagia during the first week after treatment, which subsided by 3 months. No behavioral or cognitive disturbances were found on neuropsychological testing. For patients in the off-medication state, MDS-UPDRS III scores improved by 52.6% between baseline and 6 months after the second FUS-STN (from 37.5 [IQR, 34.2-40.0] to 20.5 [IQR, 8.7-24.0]; median difference, 23.0 [95% CI, 7.0-33.7]; P = .03). The second treated side improved by 64.3% (MDS-UPDRS III score, 17.0 [IQR, 16.0-19.5] prior to the second treatment vs 5.5 [IQR, 3.0-10.2]; median difference, 9.5 [95% CI, 3.2-17.7]; P = .02). After the second procedure, all self-reported PGI-C scores were positive. Findings of this pilot study suggest that staged bilateral FUS-STN was safe and effective for the treatment of PD, although mild but persistent speech-related adverse events were observed among a small number of patients.

Identifying Novel Subtypes of Functional Gastrointestinal Disorder by Analyzing Nonlinear Structure in Integrative Biopsychosocial Questionnaire Data.

Background/Objectives: Given the limited success in treating functional gastrointestinal disorders (FGIDs) through conventional methods, there is a pressing need for tailored treatments that account for the heterogeneity and biopsychosocial factors associated with FGIDs. Here, we considered the potential of novel subtypes of FGIDs based on biopsychosocial information. Methods: We collected data from 198 FGID patients utilizing an integrative approach that included the traditional Korean medicine diagnosis questionnaire for digestive symptoms (KM), as well as the 36-item Short Form Health Survey (SF-36), alongside the conventional Rome-criteria-based Korean Bowel Disease Questionnaire (K-BDQ). Multivariate analyses were conducted to assess whether KM or SF-36 provided additional information beyond the K-BDQ and its statistical relevance to symptom severity. Questions related to symptom severity were selected using an extremely randomized trees (ERT) regressor to develop an integrative questionnaire. For the identification of novel subtypes, Uniform Manifold Approximation and Projection and spectral clustering were used for nonlinear dimensionality reduction and clustering, respectively. The validity of the clusters was assessed using certain metrics, such as trustworthiness, silhouette coefficient, and accordance rate. An ERT classifier was employed to further validate the clustered result. Results: The multivariate analyses revealed that SF-36 and KM supplemented the psychosocial aspects lacking in K-BDQ. Through the application of nonlinear clustering using the integrative questionnaire data, four subtypes of FGID were identified: mild, severe, mind-symptom predominance, and body-symptom predominance. Conclusions: The identification of these subtypes offers a framework for personalized treatment strategies, thus potentially enhancing therapeutic outcomes by tailoring interventions to the unique biopsychosocial profiles of FGID patients.

Online dance versus online therapeutic exercise on quality of life - a study protocol for a randomized controlled trial investigating social telerehabilitation efficacy in Parkinson disease

Background Social telerehabilitation delivers rehabilitation services over online video conferencing within a social context. The modality of multimodal therapeutic exercises is the most recommended rehabilitation for individuals with PD, although other modalities, such as dance, have shown potential benefits. The investigation of the feasibility and efficacy of these therapeutic strategies in a remote online format is unknown. Methods This is a prospectively registered two-arm randomised controlled trial investigating the efficacy of online dance compared to online multimodal therapeutic exercise by looking at the biopsychosocial PD aspects. Individuals diagnosed with idiopathic PD between 40 and 90 years old, at any stage of disease severity, and without cognitive impairment will be recruited from the community. Participants will be randomly allocated to one of the two social telerehabilitation groups: (1) dance and music or (2) multimodal therapeutic exercise and music. Interventions will occur twice a week for twelve weeks. Each session will last 60 min. Tele-assessments will be conducted pre-, post-, and one-month follow-up through a videoconference platform. Results For feasibility, primary outcomes will include adherence, attendance, adverse events, and participants’ perceptions of enjoyment and socialisation. For efficacy, primary outcomes will investigate well-being by positive affect (by the Positive Affect and Negative Affect Schedule) and persistent anxiety, episodic anxiety, and avoidance behaviour (by the Parkinson Anxiety Scale). Secondary outcomes will include motor severity (by the UPDRS III), functional lower extremity strength (by the Five Times Sit to Stand Test), memory and attention (by the Attention and Recognition Memory Test), and quality of life (by the Parkinson’s Disease Questionnaire 39). Conclusion We hypothesise that both interventions would effectively ameliorate motor symptoms. However, we expect dance to be more enjoyable and improve well-being by increasing positive affect and reducing anxiety signs.

Therapeutic effect of Wendan Decoction combined with mosapride on gastroesophageal reflux disease after esophageal cancer surgery.

Gastroesophageal reflux disease (GERD) is a common complication of esophageal cancer surgery that can affect quality of life and increase the risk of esophageal stricture and anastomotic leakage. Wendan Decoction (WDD) is a traditional Chinese herbal formula used to treat various gastrointestinal disorders, such as gastritis, functional dyspepsia, and irritable bowel syndrome. Mosapride, a prokinetic agent, functions as a selective 5-hydroxytryptamine 4 agonist, enhancing gastrointestinal motility. To evaluate the therapeutic effects of WDD combined with mosapride on GERD after esophageal cancer surgery. Eighty patients with GERD were randomly divided into treatment (receiving WDD combined with mosapride) and control (receiving mosapride alone) groups. The treatment was conducted from January 2021 to January 2023. The primary outcome was improved GERD symptoms as measured using the reflux disease questionnaire (RDQ). The secondary outcomes were improved esophageal motility (measured using esophageal manometry), gastric emptying (measured using gastric scintigraphy), and quality of life [measured via the Short Form-36 (SF-36) Health Survey]. The treatment group showed a notably reduced RDQ score and improved esophageal motility parameters, such as lower esophageal sphincter pressure, peristaltic amplitude, and peristaltic velocity compared to the control group. The treatment group showed significantly higher gastric emptying rates and SF-36 scores (in both physical and mental domains) compared to the control group. No serious adverse effects were observed in either group. WDD combined with mosapride is an effective and safe therapy for GERD after esophageal cancer surgery. It can improve GERD symptoms, esophageal motility, gastric emptying, and the quality of life of patients. Further studies with larger sample sizes and longer follow-up periods are required to confirm these findings.

Measuring burden of disease in both asthma and COPD by merging the ACQ and CCQ: less is more?

Symptoms of asthma and COPD often overlap, and both diseases can co-exist in one patient. The asthma control questionnaire (ACQ) and clinical COPD questionnaire (CCQ) were developed to assess disease burden in respectively asthma or COPD. This study explores the possibility of creating a new questionnaire to assess disease burden in all obstructive lung diseases by integrating and reducing questions of the ACQ and CCQ. Data of patients with asthma, COPD and asthma-COPD overlap (ACO) were collected from a primary and secondary care center. Patients completed ACQ and CCQ on the same day. Linear regression tested correlations. Principal Component Analysis (PCA) was used for item reduction. The secondary cohort with asthma and COPD patients was used for initial question selection (development cohort). These results were reproduced in the primary care cohort and secondary cohort of patients with ACO. The development cohort comprised 252 patients with asthma and 96 with COPD. Correlation between ACQ and CCQ in asthma was R = 0.82, and in COPD R = 0.83. PCA determined a selection of 9 questions. Reproduction in primary care data (asthma n = 1110, COPD n = 1041, ACO = 355) and secondary care data of ACO patients (n = 53) resulted in similar correlations and PCA-derived selection of questions. In conclusion, PCA determined a selection of nine questions of the ACQ and CCQ: working title ‘the Obstructive Lung Disease Questionnaire’. These results suggest that this pragmatic set of questions might be sufficient to assess disease burden in obstructive lung disease in both primary as secondary care.

Transcultural adaptation to Spain of the CDPQOL questionnaire specific for coeliac children.

This study aimed to translate, cross-culturally adapt, and validate the CDPQOL questionnaire, a coeliac disease (CD)-specific paediatric health-related quality of life (HRQoL) instrument (CDPQOL), in Spanish children with CD. The CDPQOL questionnaire has two versions for children aged 8-12 and 13-18. Translation and linguistic validation were performed following an international consensus process. Internal consistency was calculated using Cronbach's alpha and McDonald's omega coefficients, and convergent validity was assessed with average variance extracted (AVE). Confirmatory factor analysis (CFA) and exploratory factor analysis (EFA), when necessary, were carried out to assess the construct validity. A total of 235 children were included. In the 8-12 age group, a change in the distribution of items to a new structure of three dimensions (negative emotions, food feelings and social interaction) was required. In this new model, CFA supported the fit of the model (χ2/gl = 1.79, RMSEA = 0.077 (IC 95% 0.05-0.100), CFI = 0.969, TLI 0.960, SRMR = 0.081) and Cronbach's alpha and McDonald's omega coefficients were > 0.7 in all three dimensions. In the 13-18 age group, CFA showed that all fit indexes were acceptable (χ2/gl = 1.702, RMSEA = 0.102 (IC 95% 0.077-0.127), p < 0.001, CFI = 0.956, TLI = 0.947, SRMR = 0.103) and Cronbach's alpha and McDonald's omega coefficients were > 0.7 in all three dimensions, except for uncertainty dimension. Conclusions: The Spanish version of the CDPQOL questionnaire is a useful instrument to assess quality of life in coeliac children whose native language was Spanish spoken in Spain, with changes in item distribution in the younger age group questionnaire. What is Known: • The first specific questionnaire for coeliac children, Dutch Coeliac Disease Questionnaire (CDDUX), which focuses on diet, was translated into Spanish and validated allowing to evaluate the HRQoL of Spanish coeliac children. • Spanish Children and parents feel the disease had no substantial negative impacts on patient HRQoL using this questionnaire, similar to that observed with other countries. What is New: • The age specific for CD children (CDPQOL) was elaborated in the USA and focuses on other aspects not evaluated by CDDUX such as emotional and social issues related to living with CD. • The CDPQOL was translated into Spanish and validated allowing it to be used to assess Spanish coeliac children's QoL.

Study protocol of the GRoningen early-PD Ambroxol treatment (GREAT) trial: a randomized, double-blind, placebo-controlled, single center trial with ambroxol in Parkinson patients with a GBA mutation.

To date, no disease modifying therapies are available for Parkinson's disease (PD). Since PD is the second most prevalent neurodegenerative disorder, there is a high demand for such therapies. Both environmental and genetic risk factors play an important role in the etiology and progression of PD. The most common genetic risk factor for PD is a mutation in the GBA1(GBA)-gene, encoding the lysosomal enzyme glucocerebrosidase (GCase). The mucolytic ambroxol is a repurposed drug, which has shown the property to upregulate GCase activity in-vitro and in-vivo. Ambroxol therefore has the potency to become a disease modifying therapy in PD, which was the reason to design this randomized controlled trial with ambroxol in PD patients. This trial is a single-center, double-blind, randomized, placebo-controlled study, including 80 PD patients with a GBA mutation, receiving either ambroxol 1800 mg/day or placebo for 48 weeks. The primary outcome measure is the Unified Parkinson's Disease Rating Scale motor subscore (part III) of the Movement Disorder Society (MDS-UPDRSIII) in the practically defined off-state at 60 weeks (after a 12-week washout period). Secondary outcomes include a 3,4-dihydroxy-6-18F-fluoro-I-phenylalanine ([18F]FDOPA) PET-scan of the brain, Magnetic Resonance Imaging (with resting state f-MRI and Diffusion Tensor Imaging), GCase activity, both intra- and extracellularly, sphingolipid profiles in plasma, Montreal Cognitive Assessment (MoCA), quality of life (QoL) measured by the Parkinson's Disease Questionnaire (PDQ-39) and the Non-Motor Symptom Scale (NMSS) questionnaire. Ambroxol up to 1200 mg/day has shown effects on human cerebrospinal fluid endpoints, which supports at least passage of the blood-brain-barrier. The dose titration in this trial up to 1800 mg/day will reveal if this dose level is safe and also effective in modifying the course of the disease. NCT05830396. Registration date: March 20, 2023.

Is PDQ-39 a reliable measure of quality of life of patients at advanced stages of Parkinson's disease considered for Deep Brain Stimulation

PurposeParkinson's disease (PD) significantly impedes, especially at its advanced stages, the health-related quality of life (QoL) of patients. The Parkinson's disease questionnaire (PDQ-39) is a widely-used measure assessing the impact of the disease on the patients' QoL. To date, the reliability of PDQ-39 has not been selectively evaluated for patients at a particular delineated stage of the PD progression. Against this backdrop, the study aimed firstly to evaluate comprehensively the internal consistency reliability of PDQ-39 and the constituent scales specifically for patients at the advanced stages of PD who were candidates for Deep Brain Stimulation (DBS) surgery, and secondly, to compare the Cronbach's alpha coefficients with those reported in other studies conducted with patients across all stages of the PD progression. MethodsThe sample included 36 Bulgarian patients (29 men and 7 women) at advanced stages of PD (Hoehn and Yahr stage 4), PD duration, M = 11.06, SD = 3.50). The internal consistency reliability of the questionnaire and the constituent scales was assessed using three criteria: Cronbach's alpha coefficients, inter-item and item-total correlations. ResultsThe internal consistency reliability indicators were satisfactory for the entire instrument and for most of the scales and similar to those reported in previous studies. None of the scales had low internal consistency reliability results across the three criteria. Except for the Communication scale, seven of the eight scales had Cronbach's alpha values that were satisfactory or marginally below the cut off score. All scales had acceptable inter-item correlations. Three of the scales (Emotional Well-Being, Cognition and Communication) contained more than one item with non-satisfactory item-total correlations. With minor exceptions, the removal of the items with low item-total correlations either did not improve or improved marginally or even decreased the Cronbach's alpha coefficients of the respective scale. The Communication scale was the only scale with a Cronbach's alpha coefficient that was both low and comparatively different to other studies and had as well low item-total correlations for all constituent items, thus showing non-satisfactory results on two of the three internal consistency reliability estimates. In contrast, the Mobility scale met all three internal consistency reliability criteria. ConclusionPDQ-39 is a reliable tool for assessing the QoL of patients at advanced stages of PD across multiple health-related domains. The questionnaire can be recommended for inclusion in the best practice guidelines for evaluating DBS candidacy and the efficacy of DBS treatment for patients’ QoL.

High Prevalence and Risk Factors of Functional Gastrointestinal Disorders Among University Students in South Korea

Functional gastrointestinal disorders are common and have high prevalence in young adults. This study aimed to identify the prevalence and risk factors of functional gastrointestinal disorders in university students. A cross-sectional study was conducted in January 2021 at two universities in a South Korean city and included 493 participants. The Rome IV criteria (for functional dyspepsia and irritable bowel syndrome) and the Korean gastroesophageal reflux disease questionnaire (for gastroesophageal reflux disease) were used to define each disease. Data were analyzed using descriptive statistics and multivariate logistic regression. Gastroesophageal reflux disease, functional dyspepsia, and irritable bowel syndrome prevalence was 18.5%, 7.5%, and 6.5%, respectively, in university students. In multivariate analysis, school year (fourth) (odds ratio [95% confidence interval] = 2.27 [0.25, 0.78]), underlying disease (odds ratio [95% confidence interval] = 2.92 [1.42, 6.04]), physical activity less than once weekly (odds ratio [95% confidence interval] = 4.84 [1.04, 22.45]), very irregular meals (odds ratio [95% confidence interval] = 4.02 [1.54, 10.49]), overeating more than 5 times weekly (odds ratio [95% confidence interval] = 3.37 [1.19, 9.56]), and academic stress (odds ratio [95% confidence interval] = 1.02 [1.01, 1.03]) were risk factors for functional gastrointestinal disorders. Our findings indicate that a comprehensive management program focusing on eating habits and psychological factors is needed to reduce the prevalence of functional gastrointestinal disorders in university students.

Association of Contrast Sensitivity with Eye Disease and Vision-Related Quality of Life

To investigate contrast sensitivity (CS) as a screening tool to detect eye disease and assess its association with both eye disease and vision-related quality of life. Cross-sectional study. Setting and population: Adults receiving care from a free clinic and a Federally Qualified Health Center in Michigan. Screening positive for eye disease and Visual Function Questionnaire (VFQ) score. Participants received a vision exam reviewed via telemedicine for disease, completed a demographic survey, and the 9-item VFQ. The ability of CS to predict eye disease was explored and area under the curve (AUC) is reported. Logistic and linear regression were used to investigate the continuous effect of CS on the probability of screening positive for eye disease and VFQ score, respectively, adjusting for age and visual acuity. 1159 included participants were, on average, 54.9 ± 14.5 years old, 62% identified as female, 34% as White, 54% as Black, 10% as Hispanic/Latino, and reported mean VFQ score of 79.7 ± 15.3. CS ranged from 0.00 to 1.95 log units (mean = 1.54 ± 0.24), 21% of eyes had glaucoma, 19% cataract, 6% DR, and 2% AMD. AUCs were 0.53 to 0.73. A 0.3 log unit decrease in better eye CS was associated with increased odds of glaucoma (odds ratio [OR] = 1.35, confidence interval [CI] = 1.09-1.67), cataract (OR = 1.35, CI = 1.05-1.72), DR (OR = 2.05, CI = 1.51-2.77), and AMD (OR = 2.08, CI = 1.10-3.91). A 0.3 log unit increase in better eye CS was associated with a 5.9 unit increase in VFQ. While CS alone is not sufficient to identify people with eye disease, it is an important measure of visual function that can add value to comprehensive eye screening.

Level of and factors associated with foot self-care among people with diabetes in Idlib Province of Northwest Syria: A cross-sectional study.

Diabetic foot and lower limb problems are among the most neglected complications during the Syrian armed conflict due to the absence of a functioning health infrastructure, including early detection and timely management of limb-threatening wounds. This study aimed to determine self-reported diabetes-related foot disease (DRFD), adherence to recommended foot self-care (FSC) practices, and associated factors among people with diabetes in war-torn Northwest Syria (NWS). This was a cross-sectional study conducted at six primary care clinics in Idlib, NWS, between March 27 and April 17, 2022, utilizing the validated interviewer-administered Diabetes Foot Disease and Foot Care Questionnaire. Data on demographic characteristics, DRFD, and FSC practices were collected. FSC score was determined by adding the points from all 12 FSC items, with a maximum score of 48, and were categorized into very poor (≤12), poor (13-24), moderate (25-36), and good (37-48). A convenience sample of 331 consecutive Syrians, aged ≥18 years, with diabetes, were invited. Multiple linear regression was used to identify variables associated with FSC practices. A total of 328 patients completed the questionnaire (response rate: 99.1%). The overall FSC score was average (mean total score 27.24, SD 7.03). Over one-third (37.8%) had a very poor/poor score, 50.3% had an average score, and 11.9% had a good score. Household income/month of ≥51 USD (β = 2.6, 95% confidence interval [95% CI]:1.06-4.1, p = 0.001) and diabetes duration of ≥10 years (β = 1.8, 95% Cl: 0.2-3.4, p = 0.027) significantly predicted better FSC practice. A significant proportion of participants had inadequate adoption FSC behaviors. Higher socioeconomic status was associated with better FSC practices. Future research should evaluate diabetic foot education and professional foot care in this population.

Surgically-relevant quality of life thresholds for the Short Inflammatory Bowel Disease Questionnaire in Crohn’s disease

Background or PurposeDespite interest in patient-reported outcome measures to track progression in Crohn’s disease, frameworks to apply these questionnaires in the preoperative setting are lacking. Using the short inflammatory bowel disease questionnaire (sIBDQ), this study aimed to describe interpretable quality of life thresholds and examine potential associations with future bowel resection in Crohn’s disease. MethodsAdult Crohn’s disease patients completing an sIBDQ at a clinic visit between 2020-2022 were eligible. A stoplight framework was adopted for sIBDQ scores, including a ‘Resection Red zone’ suggesting poor quality of life that may benefit from discussions about surgery as well as a ‘Nonoperative Green’ zone. Thresholds were identified with both anchor- and distribution-based methods using receiver operating characteristic curve analysis and subgroup percentile scores, respectively. To quantify associations between sIBDQ scores and subsequent bowel resection, multivariable logistic regression models were fit with covariates of age, sex, body mass index, medications, disease pattern and location, resection history, and the Harvey Bradshaw Index. Incremental discriminatory value of the sIBDQ beyond clinical factors was assessed through area under the receiver operating characteristics curve (AUC) with an internal validation through bootstrap resampling. ResultsOf 2003 included patients, 102 underwent Crohn’s-related bowel resection. The sIBDQ Nonoperative Green zone threshold ranged from 61 to 64 and the Resection Red zone from 36 to 38. When adjusting for clinical covariates, a worse sIBDQ score was associated with greater odds of subsequent 90-day bowel resection when considered as a one-point (OR [95% CI], 1.05 [1.03-1.07]) or five-point change (OR [95% CI], 1.25 [1.13-1.40]). Inclusion of the sIBDQ modestly improved discriminative performance (AUC [95% CI] 0.85 [0.85 – 0.86]) relative to models that included only demographics (0.57 [0.57 – 0.58]) or demographics with clinical covariates (0.83 [0.83 – 0.84]). Discussion or ConclusionIn the decision-making process for bowel resection, disease-specific patient-reported outcome measures may be useful to identify Crohn’s disease patients with poor quality of life and promote shared understanding of personalized burden.

Validity and reliability of the Thai version of the ASCRS SPEED II preoperative OSD questionnaire in Thai cataract surgery candidates.

To develop a Thai version of the American Society of Cataract and Refractive Surgery (ASCRS)-modified Standard Patient Evaluation of Eye Dryness (SPEED) II© preoperative ocular surface disease (OSD) questionnaire (ASCRS SPEED II-Thai) and evaluate its validity and reliability in Thai cataract surgery candidates. The original English version of the questionnaire was translated and adapted cross-culturally to Thai language. The ASCRS SPEED II-Thai was evaluated for content validity, internal consistency, and test-retest reliability. Five experts in the ocular surface field critically reviewed the ASCRS SPEED II-Thai to measure the content validity indexes (CVI). A total of 105 cataract surgery candidates were recruited from an ophthalmology clinic to complete the questionnaire. Cronbach's alpha and intraclass correlation coefficient (ICC) were calculated to assess internal consistency and test-retest reliability, respectively. During the translation and cross-cultural adaptation processes, only two minor modifications were made to the original version for clarification without changing their meaning. All items in the ASCRS SPEED II-Thai had an item-level CVI of 1.00, representing complete agreement among content experts. The scale-level CVI was 1.00, indicating excellent content validity of the questionnaire. The participants found no difficulty in understanding each question in the pilot test. Cronbach's alpha for the ASCRS SPEED II-Thai was 0.82, indicating good internal consistency. The test-retest reliability was good to excellent, with ICC values ranging from 0.83 to 1.00 (P < 0.001). The ASCRS SPEED II-Thai is a valid clinical tool with adequate reliability for preoperative OSD screening among Thai cataract surgery candidates.

Effectiveness and Safety of Meridian Activation Remedy System for Alleviating Motor Symptoms in Parkinson's Disease: an Observational Study.

Parkinson's disease (PD) lacks disease-modifying drugs or sustainable interventions, creating an unmet treatment need. Investigating complementary and alternative medicines aims to improve PD patients' quality of life by alleviating symptoms and delaying the course of the disease. In this single-center, prospective, observational, single-arm study, we aimed to assess the effectiveness and safety of acupuncture combined with exercise therapy and the Meridian Activation Remedy System (MARS). From March to October 2021, 13 PD patients with Hoehn and Yahr stages 1 to 3 were recruited. For 8 weeks, MARS intervention was carried out twice a week. T-statistics were used to evaluate functional near-infrared spectroscopy (fNIRS) and GAITRite outcomes. All of the remaining outcome variables were evaluated using the Wilcoxon signed-rank test. The MARS intervention significantly reduced PD patients' Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDSUPDRS) Part III score (from 20.0 ± 11.8 to 8.8 ± 5.5, p = 0.003), 10-meter walk test speed (from 9.5 ± 1.8 to 8.7 ± 1.3 seconds, p = 0.040), and timed up and go time (from 9.8 ± 1.8 to 8.9 ± 1.4 seconds, p = 0.040). Moreover, the MDS-UPDRS Part II, fNIRS hemodynamics, 360-degree turn test, fall efficacy scale, and Parkinson's Disease Questionnaire 39 scores improved but not significantly. All participants completed the 8-week intervention without any adverse reactions. An 8-week MARS intervention improved motor symptoms in PD patients. In particular, improvements in UPDRS Part III scores exhibited large clinically important differences. The findings are encouraging, and a randomized controlled trial will be conducted to determine the efficacy and cost-effectiveness of MARS intervention.

Enhancing life with celiac disease: unveiling effective tools for assessing health-related quality of life.

Celiac disease (CD) is an autoimmune chronic enteropathy provoked by gluten ingestion in genetically predisposed individuals. Considering it´s only safe treatment is a lifelong gluten-free diet, the burden of living with the disease becomes evident, as well as the need to assess CD health-related quality of life (HRQOL). This review aims to identify and analyze the instruments used to evaluate the HRQOL of adults with CD. This integrative review using a systematic approach was designed to achieve high scientific standards. Accordingly, the search strategy was developed and executed as recommended by the guideline of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Detailed individual searches were developed to Pubmed, Science Direct, Scopus, Web of Science, and Google Scholar. After careful analysis of the papers, 43 studies were included, in which seven instruments were identified: Celiac Disease Questionnaire (CDQ) (n=21), Celiac Disease Specific Quality of Life Instrument (CD-QOL) (n=17), Celiac Disease Assessment Questionnaire (CDAQ) (n=4), CeliacQ-7 (n=1), CeliacQ-27 (n=1), Black and Orfila´s self-developed instrument (n=1) and the Coeliac Disease Quality of Life Questionnaire (CDQL) (n=1). The CDQ and CD-QOL were the two most applied instruments. Since the first focuses on the physical and mental symptoms related to the disease and the second focuses on the emotional repercussions of adhering to the GFD treatment for life (dysphoria), the CDQ application is an interesting option for countries that struggle with public policies for CD patients and patients with active CD. The CD-QOL could be used for countries with strict regulations for CD and gluten-free products and populations in remission. When comparing results among different populations, it is preferable to utilize culturally validated instruments, which have been applied across multiple countries, providing greater comparability between study findings.