Patient Questionnaire Research Articles

Comparison of the effect of self-care education with two methods, teach-back and smartphone application, on the adherence to treatment in patients with inflammatory bowel disease.

Self-care is one of the basic principles in the management of chronic diseases, which influences follow-up and adherence to treatment. Therefore, the current study was conducted with the aim of comparing the effect of teach-back (TB) and a smartphone application on adherence to treatment in patients with inflammatory bowel disease (IBD). The current clinical trial was conducted among 80 patients with IBD in Mashhad, Iran, in 2021-2022. Self-care education (diet, personal and social relationships, medications, sleep, physical activity, sexual relationships, etc.) was provided through TB method in one group and by using a smartphone application in another group. The control group only received the routine education. A checklist for demographic information and the adherence questionnaire in patients with chronic diseases were used for data collection. Patients' mean age was 38.73 ± 10.32 years. The majority of patients had ulcerative colitis (81%) and were married (67%). Mean and standard deviation score of adherence to treatment were the same in all three groups before the intervention (P = 0.668). The mean post-test scores of adherence to treatment in the TB, application, and control groups were 170.04 ± 14.19, 167.99 ± 11.59, and 159.60 ± 10.94, respectively. The difference was statistically significant (P = 0.003). A significant difference was observed in regards to the mean post-test scores of adherence to treatment between TB and control groups (P = 0.004) and app and control groups (P = 0.048). However, the difference between TB and app groups was not significant (P = 0.989). TB method and smartphone application have the same effect on adherence to treatment in patients with IBD. Due to the usability and cost-effectiveness of smartphone applications, this method can be used by health-care providers to educate this group of patients.

Sex-related differences in health-related quality-of-life measured using the EuroQol 5-Dimension questionnaire across the LVEF spectrum in DAPA-HF and DELIVER

Abstract Background Although sex-related differences in response to disease-specific health-related quality-of-life (HRQL) instruments such as the KCCQ have been investigated in patients with heart failure (HF), this is not the case for generic HRQL instruments. Purpose To assess the sex-specific differences in health status measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) in patients with HF with reduced and mildly reduced or preserved ejection fraction (HFrEF and HFmrEF/HFpEF), and to assess the effect of dapagliflozin on EQ-5D-5L index scores. Methods Using patient-level data from the DAPA-HF and DELIVER trials comparing dapagliflozin to placebo, we analysed patient-reported outcomes for each dimension of the EQ-5D index scores between men and women. The 5 dimensions of the descriptive section of the EQ-5D-5L include mobility ("walking around"), self-care ("washing or dressing self"), usual activities ("e.g., work, study, housework, family or leisure activities"), pain/discomfort ("pain or discomfort"), and anxiety/depression ("anxious or depressed"). Each dimension is divided into 5 levels (1-5) i.e., no problem, slight problem, moderate problem, severe problem, and extreme problem (cannot do activity/extreme symptom). Results Of 4744 patients with HFrEF, 4390 completed the EQ-5D-5L index scores (3408 men and 982 women, 77.6% vs. 22.4%). The correresponding numbes in 6263 patients with HFmrEF/HFpEF were 5745 overall and 3320 men vs. 2425 women (57.8% vs. 42.2%). Regardless of HF phenotype, women had significantly worse (lower) baseline index scores overall compared to men (0.849 vs. 0.899 in HFrEF and 0.844 vs. 0.884 in HFmrEF/HFpEF, both p<0.001). Although scores varied markedly by question, women generally had worse health status in all the dimensions as compared with men in patients with HFrEF (39% vs. 29% reporting a moderate or greater problem for mobility, 17% vs. 9% for self-care, 36% vs. 25% for usual activities, 29% vs. 19% for pain/discomfort, and 21% vs. 13% for anxiety/depression, all p<0.001) (Figure, top panel). A broadly similar pattern was observed in HFmrEF/HFpEF (Figure, bottom panel). In all patients, across the range of LVEF, there dapagliflozin led to a significant placebo corrected increase (improvement) in index score (0.008, 95% CI 0.002 to 0.014), with no interaction between sex and the effect of dapagliflozin (p for interaction with sex = 0.50). Conclusions Women reported significantly poorer health status in both HFrEF and HFmrEF/HFpEF compared to men. Dapagliflozin treatment improved EQ-5D index scores irrespective of sex across the range of ejection fraction. Figure Sex differences in the distribution of responses to EQ-5D-5L questionnaire. EQ-5D-5L, EuroQol 5-Dimension 5-Level questionnaire; HFmrEF, heart failure with mildly reduced ejection fraction; HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction.

Patient-Reported Indicator Surveys (PaRIS): measuring patient reported experiences and outcomes across populations and health systems

Abstract We aimed to develop and test the performance of a questionnaire for adults (aged 45 or older) with one or more chronic conditions who use primary/ambulatory care across populations and health systems in multiple countries. Candidate scales and items were identified through a systematic process supported by international stakeholders (PaRIS Patient Advisory Panel, Technical Advisory Community and Working Party members of participating countries). Four instruments for each domain, covering patient reported outcome measures (PROMs), patient reported experience measures (PREMs), health behaviours, and health and health care capabilities, were shortlisted using predefined criteria and evaluated using the EMPRO method. A modified Delphi supported selecting a core instrument for each domain and additional relevant scales/items. Consultations took place with the stakeholders to confirm the suitability of the proposed questionnaire. The questionnaire was evaluated through cognitive testing and further modified accordingly. The survey was piloted in a Field Trial. Psychometric evaluation was conducted with data from a Field trial on an item level and scale level. Out of 217 instruments, the Delphi resulted in consensus on a core instrument for each main domain and additional questions to ensure comprehensiveness. The cognitive testing of the draft survey (17 languages, 20 countries) confirmed that most questions were interpreted as intended. The version of the survey developed for the field trial included 118 questions. The field trial psychometric evaluation was based on 10,145 patients, across 18 countries. The questionnaire performed well at item level and at scale level. Performance in terms of structure and validity was good overall. A revised version of the patient questionnaire was created with 115 items. A comprehensive questionnaire has been constructed based on the PaRIS survey framework for people living with chronic conditions and following an inclusive approach.

Factor structure and validation of the electronic form of the Oxford Happiness Questionnaire in patients with COVID-19

Background and Objectives: Background and Aim: Validity Scale Validation can help identify coronavirus disease patients; therefore, the aim of this study was to evaluate the validation of the electronic form of the Oxford Happiness Questionnaire in patients with COVID-19. Methods: This study is instrumental psychometrics that the statistical population includes all patients in 19 cases in Tehran. The number of samples was determined based on psychometric criteria to be 100 for the predictive validity section and 251 for the convergence validity section. Samples were selected by cluster sampling. Research data were collected electronically through two questionnaires of happiness (Oxford) and happiness of positive psychological characteristics by sending the questionnaire link to the participants' mobile phones. To evaluate the validity of the scale, content validity, convergence, and factor analysis methods were used. The reliability of the scale was assessed by internal consistency methods and class reliability. Results: The results of exploratory factor analysis showed that the researcher-made questionnaire consists of three factors and has good validity and reliability. The second-order confirmatory factor analysis also confirmed the three-factor model. This questionnaire was administered along with the short form of the Oxford Happiness Scale, which had 13 items of good reliability and validity. Conclusion: The Oxford Happiness Scale in COVID-19 patients can be used to assess happiness in COVID-19 patients.

Performance Analysis of Slamet Riyadi Hospital Pharmacy Installation Surakarta Using Balanced Scorecard Method

This study aims to determine the extent to which the performance of the Pharmacy Installation of the Hospital Class III 04.06.04 Slamet Riyadi Surakarta with the Balanced Scorecard method. This study is a non-experimental study with an exploratory and descriptive design. Data were collected retrospectively and simultaneously with in-depth interviews with pharmacists of the pharmacy facility, staff and patient questionnaires, and direct observation. Data were analyzed descriptively and compared with existing standards. The findings indicate that 1) Financial perspective performance, TOR values are not yet in accordance with standards, the average GPM value is in accordance with the standard of 20-33% and the GROS value has not met the standard. 2) Customer perspective performance shows that there is high patient satisfaction with the performance of the Hospital Pharmacy Installation. However, there is a significant gap between satisfaction with its performance and patient expectations. Customer retention has increased customer acquisition in period one to period two. 3) Internal business perspective performance shows that drug availability reaches an optimal 100%, dispensing time for compounded prescriptions meets the standard, but for non-compounded prescriptions has not met the standard. PIO is delivered optimally 100% on information on indications, dosages, rules of use, side effects and related contraindications and how to store drugs have not been given to all patients. 4) The performance of the learning and growth perspective shows that satisfaction and work enthusiasm have a high category and the Hospital Information Management (SIM) system has not been optimally integrated. 5) The results of the SWOT analysis are included in quadrant II with a diversification strategy.

Association between varicose veins and constitution of traditional Chinese medicine plus heart-failure-like symptoms

BackgroundVaricose veins are a common issue for employees in jobs that require prolonged standing compared with all other employees. However, its relationship with presentations of traditional Chinese medicine constitution is unknown. This study aimed to investigate their association.Material and methodsData in the study were obtained from questionnaires of patients in Taiwan Biobank, enrolled from 2008 to 2020. The responses to the statement “I can see distorted blood vessels on my four limbs (varicose veins).” were categorized into none, mild, moderate, severe. and more severe, and the same scale was also used to classify breathing difficulties and hypotension.ResultsA total of 11,293 participants were enrolled in the study. The prevalence of women was higher in the studied group compared with the control. Patients complained of breathing difficulties with moderate (30.49%) and severe discomfort (12.44%) in the diseased group. Regarding hypotension, 28.81% and 9.82% of the patients presented with moderate and severe hypotension, respectively. The cofactor odds ratio was 1.775 for severe breathing difficulty/moderate hypotension and 2.235 for severe breathing difficulty/severe hypotension, with statistical significance. The combined impact of breathing difficulties and hypotension increased with severity.ConclusionsVaricose veins had a higher association with breathing difficulties and hypotension as the severity of the condition worsened. The combined impact of breathing difficulties and hypotension increased as the disease progressed. Therefore, self-reported assessments can be a useful tool for evaluating patients with asymptomatic varicose veins before the development of “heart-failure-like symptoms” to reduce the risk of underdiagnosis.

Impact of Anastomotic Leakage After Colorectal Cancer Surgery on Quality of Life: A Systematic Review.

Colorectal anastomotic leakage remains one of the most frequent and dreaded postoperative complications following colorectal resection. However, limited research has been conducted on the impact of this complication on quality of life of patients undergoing colorectal cancer surgery. The aim of this systematic review was to identify, appraise and synthesize the available evidence regarding quality of life in patients with anastomotic leakage following oncological colorectal resections in order to inform clinical decision-making. PubMed, Embase, and the Cochrane library were searched for studies reporting on quality of life using validated questionnaires in patients with anastomotic leakage after oncological colorectal resections. The literature search was performed systematically and according to PRISMA guidelines. Outcomes of quality of life questionnaire scores of patients with and without anastomotic leakage were analyzed. Thirteen articles reporting on 4618 individual patients were included, among which 527 patients developed anastomotic leakage. Quality of life was evaluated utilizing ten distinct questionnaires administered at various postoperative time points, ranging from 1 month to 14 years. Quality of life outcomes differed across studies and timepoints, but overall scores were most negatively affected by anastomotic leakage up to 12 months postoperatively. There was a high heterogeneity between the included studies based on used questionnaires and time of assessment. The published evidence suggests that anastomotic leakage following oncologic colorectal resection is associated with impaired quality of life, especially within the first postoperative year. The impact of anastomotic leakage on quality of life warrants further evaluation and discussion with patients.

Роль и место медицинской информационной системы при оказании дерматологической помощи в частной медицинской организации

Dermatological diseases retain statistically significant positions in the structure of modern somatic pathology and are often characterized by severe medical and social consequences. The latter include an unreasonably high number of unsatisfactory treatment results, high level of expenses for diagnostics and treatment, low level of patient satisfaction. Taken together, this allows us to consider the comprehensive quality of dermatological care as a whole insufficient. Medical organizations in the private healthcare segment are no exception in this regard. One of the modern effective directions in improving the quality of a wide variety of types of medical care for the population is the widespread use of the so-called medical information systems (MIS). However, at the level of dermatological organizations in the private healthcare segment, this direction has not been practically worked out to date. Purpose of the study: improving the quality of dermatological care for the population in a private medical organization based on the development and implementation of a medical information system. Materials. The study included 2000 dermatological patients of a private medical organization. The control group (1000 people) consisted of patients in the period before the implementation, the main group (1000 people) – patients in the period after the implementation of the developed system. The duration of the compared periods was 2,5 years. Мethods. To obtain the results, the methods of objective examination, specialized patient questionnaires, simple and extended dermatoscopy, content analysis of medical documentation and databases of the medical organization, pharmacoeconomic analysis were used. The system of integrated assessment of the quality of medical care was applied. The methods of variation statistics were used to analyze the results. The exact level of statistical significance of differences in the results before and after the implementation of the developed MIS was calculated.. Subject. The study is at the intersection of two subject areas: «Organization of dermatological care for the population» and «Medical information systems». Results. As part of this study, a MIS was developed aimed at improving the organization of dermatological care for the population. The system was implemented in a medical organization in the private healthcare segment. The main results of such implementation were: an increase in the number of successful treatment results, the level of patient satisfaction with the quality of dermatological care, the level of its standardization, a decrease in direct economic costs for diagnostics and treatment. The integrated and comprehensive indicators of the quality of dermatological care have been increased.. Conclusion. Improving the quality of dermatological care for the population in a medical organization of the private healthcare segment based on the development and implementation of a medical information system has been achieved. The results obtained have a high level of statistical and medical-social significance.

Translation and Validation of the Diabetes Knowledge Questionnaire in Indonesian Patients With Type 2 Diabetes.

The purpose of the study was to translate and cross-culturally adapt the 24-item Diabetes Knowledge Questionnaire (DKQ) for Indonesian patients with type 2 diabetes (T2D) and evaluate its psychometric properties. Forward-backward translation, adaptation involving 7 experts, and pretesting to develop the Indonesian version of DKQ were conducted. Psychometric analysis was carried out among T2D patients from 40 primary health care centers in Indonesia. Known-group, convergent and discriminant validity, internal consistency and test-retest reliability were assessed. Additionally, a descriptive item analysis was conducted. In total, 39 patients participated in the pretesting and 304 patients in the validation process and descriptive analysis. Of the 24 items, 2 were adjusted during the adaptation process, and 1 item was deleted because it did not adequately reflect the original item. Known-group validity was demonstrated because patients with younger ages, higher educational levels, and longer diabetes duration had significantly higher DKQ scores. Convergent validity was demonstrated by a significant positive correlation of the DKQ scores with overall treatment satisfaction. The 23-item DKQ Bahasa Indonesia showed satisfactory internal consistency (Cronbach's α = 0.73; omega total = 0.72) and good test-retest reliability (intraclass correlation coefficient = 0.87 in a sample of 27 patients). No floor and ceiling effects were found in the item analysis. The study demonstrates adequate validity and reliability of the 23-item DKQ Bahasa Indonesia for assessing diabetes knowledge in Indonesian primary care patients with T2D. This instrument can be used to identify room for improvement and develop diabetes education programs.

Outcome of posterior short segment fixation with implanting pedicle screw at the fractured level for treatment of thoracolumbar fracture

IntroductionThoracolumbar fractures make up majority of the spinal fractures. Various techniques including long, short, mono and short segment screw fixation have been used to achieve stability. There are still few studies describing the results of short segment fixation with intermediate screw fixation in fractured vertebrae, despite the fact that all have adequate efficacy and stability. Materials and methods41 patients were studied and evaluated preoperatively, at discharge and at 2, 6, 12, 24 weeks and 1 year follow-up clinically using Greenough and Fraser Low Back Pain Score, the American Spinal Injury Association (ASIA) grading, four-point scale questionnaire for patient's satisfaction, sagittal index (SI) of injured vertebra and Cobb's angle. ResultsThe patient's mean age was 36.9 ± 11.7 years, majority (90.2 %) with lumbar (L1-L3) segment involvement. All the patients significantly improved neurologically immediately after surgery (p < 0.001) however the improvement was not significant at final follow up (p = 0.3) as compared to the preoperative ASIA grade (Kendall's tau-b test). Low back pain decreased significantly on subsequent follow-up as measured by Visual Analogue Scale (VAS) score (p < 0.001). The Low Back Pain Scale of Greenough and Fraser calculated at immediate post-operation and at 1 year follow up in comparison to pre-operation status showed a statistically significant improvement (p < 0.001). Sagittal index (SI) estimated at 6, 12, 24 weeks and 1 year follow-up in comparison to preoperative SI was higher and statistically significant (p < 0.001). Mean Cobb's angle significantly decreased during follow-up at 6, 12, 24 weeks and 1 year compared to preoperative angle (p < 0.001). Four Point Scale Questionnaire assessed at 1 year follow-up showed majority (82.9 %) were very satisfied with the outcome. ConclusionPosterior short segment with intermediate screw fixation in fractured vertebra is a feasible and stable treatment method for traumatic single thoracolumbar fracture with respect to the functional outcome, patient satisfaction and preservation of motion segment.

The Romanian Translation and Cultural Adaptation of the Early Arthritis for Psoriatic Patients (EARP) Questionnaire, Psoriasis Epidemiology Screening Tool (PEST), and Toronto Psoriatic Arthritis Screen 2 (ToPAS 2).

Psoriasis is a chronic inflammatory condition mediated by the immune system with various manifestations. The increased prevalence of subclinical joint involvement has led to the development of early diagnostic methods for psoriatic arthritis, including several instruments that have been validated and used in clinical practice. The aim of this study was to perform the Romanian translation, cultural adaptation, and validation of three assessment tools: the Early Arthritis for Psoriatic Patients (EARP) Questionnaire, Psoriasis Epidemiology Screening Tool (PEST), and Toronto Psoriatic Arthritis Screen 2 (TOPAS 2), which are designed to evaluate early-stage arthritis in patients with psoriasis. All the activities were carried out in accordance with the internationally recognized methodology recommended by the International Society for Pharmacoeconomics and Outcome Research (ISPOR), the recommendations of the World Health Organization (WHO) regarding the translation process and the validation of instruments, and data from the international literature. These three questionnaires were administered to 29 patients with psoriasis diagnosed by biopsy. A descriptive study was conducted and the data were analyzed with appropriate statistical tests using the PSPP program. A reliability test was assessed using Cronbach's alpha coefficient. The obtained values were significant for the first two questionnaires, with a value of 0.89 for the EARP and 0.63 for the PEST, but the value was not as significant for ToPAS2, at 0.40. This pilot study revealed that the Romanian and original versions of the three questionnaires are similar.

Development and evaluation of a questionnaire to capture environmental and occupational inhalational exposures in adults with fibrotic interstitial lung disease

BackgroundIdentification of exposures in patients with interstitial lung diseases (ILDs) is essential for diagnosis and management and can be facilitated through the use of exposure questionnaires. However, for most ILDs, a patient-focused questionnaire is lacking. Cognitive interviewing is a methodology used to evaluate sources of understanding and misunderstanding in a questionnaire and to provide evidence of content validity. We developed and refined a new exposure questionnaire for patients with fibrotic ILDs by using cognitive interviewing to establish its understandability and content validity.MethodsAn exposure assessment questionnaire was developed by a multidisciplinary team. Cognitive interviews with 24 patients with fibrosing ILDs were conducted by trained interviewers over the phone or Zoom using a semi-structured interview guide. The questionnaire was amended based on the interviewers’ interpretation of sources of misunderstanding. The revised questionnaire was tested in a second round of cognitive interviews with a different group of 24 patients.ResultsAmong the 48 patients who completed interviews, mean age was 61 years, 58.3% were male and 75.0% were white. Based on the first round of cognitive interviews, the multidisciplinary team modified the questions, organization, and instructions of the questionnaire to facilitate recall, adjust for exposures that were frequently misunderstood or required clarification, and focus on clinically relevant exposures. The revised questionnaire performed well in the second round of interviews.ConclusionAn exposure questionnaire, developed with input from patients, can be used to assess clinically relevant exposures in adults with fibrosing ILDs. This is the first questionnaire for all types of fibrosing ILD to have undergone content validation.

Patient perceptions of an electronic-health-record-based rheumatoid arthritis outcomes dashboard: a mixed-methods study

BackgroundOutcome measures are crucial to support a treat-to-target approach to rheumatoid arthritis (RA) care, yet their integration into clinical practice remains inconsistent. We developed an Electronic Heath Record-integrated, patient-facing side-car application to display RA outcomes (disease activity, functional status, pain scores), medications, and lab results during clinical visits (“RA PRO Dashboard”). The study aimed to evaluate patient perceptions and attitudes towards the implementation of a novel patient-facing dashboard during clinical visits using a mixed-methods approach.MethodsRA patients whose clinicians used the dashboard at least once during their clinical visit were invited to complete a survey regarding its usefulness in care. We also conducted semi-structured interviews with a subset of patients to assess their perceptions of the dashboard. The interviews were transcribed verbatim and analyzed thematically using deductive and inductive techniques. Emerging themes and subthemes were organized into four domains of the Ecological Model of Health.ResultsOut of 173 survey respondents, 79% were interested in seeing the dashboard again at a future visit, 71% felt it improved their understanding of their disease, and 65% believed it helped with decision-making about their RA care. Many patients reported that the dashboard helped them discuss their RA symptoms (76%) and medications (72%) with their clinician. Interviews with 29 RA patients revealed 10 key themes: the dashboard was perceived as a valuable visual tool that improved patients’ understanding of RA outcome measures, enhanced their involvement in care, and increased their trust in clinicians and the clinic. Common reported limitations included concerns about reliability of RA outcome questionnaires for some RA patients and inconsistent collection and explanation of these measures by clinicians.ConclusionsIn both the quantitative and qualitative components of the study, patients reported that the dashboard improved their understanding of their RA, enhanced patient-clinician communication, supported shared decision-making, and increased patient engagement in care. These findings support the use of dashboards or similar data visualization tools in RA care and can be used in future interventions to address challenges in data collection and patient education.

Cross-cultural adaptation of the Quebecois Patient-Centered Coordination by a Care Team Questionnaire for use in France

BackgroundThe prevalence of chronic disease and multimorbidity is increasing and the associated disease and treatment burden is particularly heavy. Coordinated multidisciplinary, patient-centered care is particularly important for people living with chronic disease or multimorbidity. There was no valid tool to measure the quality of coordinated patient-centered care from the patient’s perspective until the Patient-Centered Coordination by a Care Team (PCCCT) questionnaire was recently developed in Canada (Quebec/Ontario). The Quebecois version has been validated but is not directly transferable to France due to linguistic, cultural and health system differences between the two countries. To perform a cross-cultural adaptation of the Quebecois PCCCT questionnaire is therefore necessary to obtain a questionnaire’s new version adapted for use in France, ensuring item and semantic equivalence.MethodsThe adaptation process consisted of two stages, both of which were supervised by a scientific committee made up of five healthcare professionals. The first stage was a Delphi consensus involving a multidisciplinary healthcare professional panel to evaluate and harmonize the clarity and appropriateness of the questionnaire for patients in the French health system. During the second stage, adult patients with one or more chronic diseases, from various age, sex, socio-occupational categories, assessed the comprehensibility and conformity of the adapted version of the questionnaire resulting from stage 1 and improved it if necessary. This was achieved using cognitive interviews.ResultsDuring Stage 1, two rounds were undertaken with 10 professional experts resulting in consensual reformulation of 10 out of the 14 items. These newly formulated items and the 4 remaining items were submitted to patients in Stage 2. Cognitive interviews were undertaken with 14 patients, testing 3 successively adapted versions of the questionnaire, until three consecutive patients did not find any ambiguity or misunderstanding. The final version resulting from the cross-cultural adaptation process aimed at being used in France, has item and semantic equivalence to the original Quebecois version.ConclusionsMeasurement equivalence will be addressed in a future study. This French version is intended to be a useful resource for the health system reforms aimed at promoting more integrated and patient-centered care pathways.

Reliability, validity, and minimal clinically important differences for the Thai-version of the Aberdeen Varicose Vein Questionnaire (AVVQ-Thai) in patients with chronic venous disease

Background Patient-reported outcome measures (PROMs) are essential for assessing the health of patients with chronic venous disease (CVD). Therefore, we aimed to translate the Aberdeen Varicose Vein Questionnaire into Thai language (AVVQ-Thai) and evaluate its reliability and validity. Minimal clinically important differences (MCID) of the AVVQ-Thai also be estimated. Methods International standards for PROM translation were followed including the forward-backwards translation of the AVVQ. Patients with Clinical-Etiology-Anatomy-Pathophysiology (CEAP) C2-C6 with truncal reflux were prospectively included. Venous interventions were used to treat reflux and varicosities. Patients’ characteristics, venous clinical severity scores (VCSS), EuroQol EQ-5D, and AVVQ-Thai were collected pre- and one-month post-intervention. AVVQ-Thai was also collected one to two weeks after the initial visit by reply-paid postal questionnaire. Results The study included 119 patients (30% C2, 29% C3, 28% C4, 11% C5, and 2% C6). The AVVQ-Thai had good internal consistency with Cronbach’s alpha of 0.783 and moderate reliability with the intraclass correlation coefficient of 0.67 (95%CI: 0.50, 0.79). The AVVQ-Thai was significantly correlated with VCSS and was able to discriminate patients with different levels of health problems as assessed by EQ-5D at both pre-and post-intervention, demonstrating good construct and discriminative validity. The median AVVQ scores improved significantly after intervention from 15.4 (IQR 8.3, 24.2) to 4.2 (IQR 1.3, 8.4) in C2-C3, and 18.9 (IQR 14.1, 25.5) to 7.3 (IQR 4.6, 16.3) in C4-C6. The MCID of the AVVQ was 6.21 on the 0-100 scale, which equates to the level of difference necessary to be clinically meaningful. Conclusions AVVQ-Thai has satisfactory evidence for internal consistency, reliability, validity, and responsiveness to change and is recommended for application in Thailand.

Quality of life under treatment with the immune checkpoint inhibitors ipilimumab and nivolumab in melanoma patients. Real-world data from a prospective observational study at the Skin Cancer Center Kiel

PurposeCombined immunotherapy (ipilimumab + nivolumab) has improved survival in stage IV melanoma patients, making Health-related Quality of Life (HrQoL) crucial due to potential immune-related adverse events (irAEs). Previous studies treated HrQoL as secondary/explorative endpoint, and no specific HrQoL questionnaire for melanoma patients on immune checkpoint inhibitor (ICI) therapy exists. This study aimed to gather specific HrQoL data during combined ICI therapy, tracking changes during and after treatment, and examining associations with gender, irAEs, and treatment response.Methods35 melanoma patients (22 males, 13 females) undergoing combined ICI were surveyed using the Short-form 36 questionnaire (SF-36), the Inflammatory Bowel Disease Questionnaire – Deutsch (IBDQ-D), and the distress thermometer (DT). HrQoL was evaluated during treatment, after six months, and at the onset of autoimmune colitis.ResultsirAEs occurred in 51.4% of patients, with colitis being the most common (26.1%). 45.7% had progressive disease. SF-36 showed stable HrQoL during treatment and follow-up. Women had worse HrQoL on the physical component scale than men (p = 0.019). Patients with progression showed worse HrQoL over time in physical (p = 0.015) and mental health scales (p = 0.04). IBDQ-D showed constant HrQoL throughout treatment and follow-up. Distress on DT remained constant, with women reporting higher levels of distress.ConclusionHrQoL remained stable during and after therapy. Female gender and disease progression negatively impacted HrQoL. The development of irAEs was not associated with HrQoL, though this may not apply to severe irAEs like colitis, which were not assessed.

Development and validation of an image-based questionnaire ARTROVIS to identify risk factors for the articular syndrome and related conditions

Background: The importance of timely diagnosis of rheumatic diseases is beyond any doubt. However, in the real practice the time from manifestation of the first symptoms to the assessment by a rheumatologist and treatment administration often exceeds the window of opportunity for disease control. At the moment, there has been no Russian-language questionnaire that would allow a primary care physician to suspect a rheumatic disease manifesting with an articular syndrome. Aim: To develop, validate and test a questionnaire to identify risk factors for joint disorders and related conditions. Methods: From November 2022 to April 2024, we performed the study on the image-based questionnaire on identification of the risk factors for joint syndromes and associated conditions (ARTROVIS), which we have developed for early detection of both joint syndromes, as well as comorbid conditions associated with elevated serum uric acid levels (hyperuricemia). The initial test version of the questionnaire was tested in a focus group of respondents (n = 20) who came for regular medical examination. Based on the results of this face validity assessment, we corrected the wording of 10 questionnaire items. At the second study step, we assessed the primary validity and reliability of the questionnaire in a group of 41 rheumatology patients. The third study step involved 828 respondents (408 men and 420 women, median age 19 [18,0; 20,0] years; 21% with joint syndromes), who came for routine medical examination. The reliability of the questionnaire, its face and discriminant validity, as well as sensitivity and specificity (the ROC analysis) were assessed from 827 questionnaires included in the final processing (one was excluded due to questionnaire completion defects). Results: The self-report questionnaire for patients (ARTROVIS) has 24 items aimed at collecting social and demographic data, identifying risk factors for non-communicable diseases, assessing genetic aspects, identifying complaints from various organ systems, providing information on medical treatments taken by the patient (non-steroid anti-inflammatory agents, diuretics, antihypertensives, glucocorticosteroids, chemotherapy and radiation therapy), as well as an additional question for women on current pregnancy pathology. The questionnaire contains visual aids (colored photos) that facilitate the detection of clinical signs of autoimmune (psoriatic arthritis, Reynolds’s syndrome) and inflammatory rheumatic disease (gout), as well as the differential diagnosis of the joint syndrome. The assessment of face validity of the questionnaire showed the total number of missed answers of 3.42%; 62.85% of the respondents gave their full answers to all items. Good discriminant validity was demonstrated. The ROC analysis showed high correlation between the questionnaire score and the presence of a joint syndrome: the area under the curve was 0.884. The Cronbach’s alfa was 0.798, which is sufficient for a medical questionnaire. Conclusion: We have performed the approbation and standardization of the questionnaire to identify risk factors for the joint syndrome and related comorbidities by assessing its validity and reliability. The ARTROVIS as a self-report questionnaire can be used in primary care as a tool enabling general practitioners and internists to decide on further patient routing to corresponding specialists.

Pilot Study to Evaluate Patients’ Understanding of Key Terms and Aspects of Antimicrobial Use in a Rural Province in South Africa Findings and Implications

Abstract Introduction: Antimicrobial resistance (AMR) is a global concern, necessitating the understanding of utilisation patterns and their rationale. Pilot studies have been conducted in a rural province in South Africa to determine the extent of self-purchasing of antibiotics by patients from independent and chain pharmacies. It is imperative to understand the extent of knowledge and concerns of patients regarding the key aspects of antibiotic use and AMR, and potential language barriers, when pharmacists and their assistants are discussing the key aspects with patients. Consequently, the aim was to pre-test a patient questionnaire translated in three native languages building on the findings from the English language pilot. Materials and Methods: The English patient questionnaire (Parts 1 and 2) was translated to Sepedi, Tshivenda and Xitsonga. In total 30 patients were interviewed (5/language for Part 1 and Part 2 respectively) when leaving 10 chain and independent pharmacies. This was followed by interviews with patients to evaluate their understanding of questions and key concepts. Results: Eleven of 15 patients interviewed for Part 1 received antibiotics, including 8 without a prescription. Only independent pharmacies (8/10) dispensed antibiotics without prescriptions. Interviews revealed concerns about antibiotic knowledge and AMR and that certain terms including ‘antibiotic’ and ‘AMR’ posed challenges with patient understanding of the purpose of antibiotics. For instance, one patient self-purchased antibiotics for ‘cleansing’ of sexually transmitted infections. The questionnaires in the native languages were subsequently revised so that explanations for terms, including ‘antibiotic’ and ‘AMR’ will be provided in the main study. Conclusion: Similar to the previous pilot studies, self-purchasing of antibiotics was observed among independent pharmacies, although at varying rates, with similar indications. Continued health literacy education for pharmacists and patients, especially with native language communication, are needed to address current challenges and will be explored in the main study.

Ventral Hernia Repair With a Hybrid Absorbable-permanent Preperitoneal Mesh.

To analyze device safety and clinical outcomes of ventral hernia repair with the GORE SYNECOR Preperitoneal Biomaterial (PRE device), a permanent high-strength mesh with bioabsorbable web scaffold technology. This multicenter retrospective review analyzed device/procedure endpoints and patient-reported outcomes in patients treated for hernia repair ≥1 year from study enrollment. Included in this analysis were 148 patients with a mean age of 56 years; 66.2% met the Ventral Hernia Working Group grade 2 classification. Median hernia size was 30.0cm 2 and 58.8% of patients had an incisional hernia. Repairs were primarily a robotic (53.4%) or open approach (41.9%). All meshes were placed extraperitoneal. Procedure-related adverse events within 30 days occurred in 13 (8.8%) patients and included 7 (4.8%) patients with surgical site infection, 2 (1.4%) with surgical site occurrence (SSO), 4 (2.7%) requiring readmission, and 3 (2.0%) who had reoperation. The rate of SSO events requiring procedural intervention was 2.7% (4 patients) through 30 days and 3.4% (5 patients) at 12 months. The rate of procedure-related surgical site infection remained at 4.8% through 12 months (no further reports after 30d) and 3.4% for SSO (2 reports after 30d). There were no site-reported clinically diagnosed hernia recurrences throughout the study. Median patient follow-up including in-person visit, physical examination, reported adverse event, explant, death, and questionnaire response was 28 months (n = 148). Median patient follow-up with patient questionnaire was 36 months (n = 88). Use of the PRE device, which incorporates the proven advantages of both an absorbable synthetic mesh and the long-term durability of a permanent macroporous mesh, is safe and effective in complex ventral hernia repairs. When used in the retromuscular space, the combination of these 2 materials had lower wound complications and recurrence rates than either type of material alone.

Development and Psychometric Evaluation of the Sexual Life Quality Evaluation Tool for Patients With Coronary Heart Disease.

Patients with coronary heart disease (CHD) will have a series of sexual problems, and their sexual life quality can be affected. However, a standardised evaluation tool for patients with CHD was lacking. Therefore, this study aimed to develop a sexual life quality questionnaire for patients with CHD and to evaluate its psychometric properties. Based on previous phenomenological studies, literature analysis and group discussion, questionnaire items were formed. After two rounds of expert consultation and pre-survey, the questionnaire items were modified. Items were screened by item analysis. Exploratory factor analysis and confirmatory factor analysis were used to explore and confirm the structure of the questionnaire. Content validity and criterion validity were evaluated using the expert consultation and correlation analysis, respectively. The questionnaire reliability was evaluated using internal consistency, split half reliability, and test-retest reliability. The sexual life quality questionnaire of patients with CHD was developed, which included two versions: male version and female version. The male version of the questionnaire contains 3 dimensions and 20 items, while the female version contains 3 dimensions and 17 items. After reliability and validity test, the two versions of the questionnaire have good reliability and validity. In this study, the sexual life quality questionnaire of patients with CHD was developed and its psychometric properties were confirmed, which can be used to evaluate the sexual life quality of patients with CHD. The development of a sexual life quality evaluation tool for patients with coronary heart disease to provide objective and quantitative tools for clinical staff to evaluate patients' sexual life status. Patients were invited to participate in a questionnaire survey for this study.