Validation of the Glaucoma Quality of Life-15 Questionnaire in Serbian language

AIM: To translate the Glaucoma Quality of Life-15 (GQL-15) to Serbian language and asses its validity and reliability in the population of Serbian patients. METHODS: The study included 177 glaucoma patients. Clinical parameters (visual acuity, mean defect and square root of loss variance of visual field) and socio-demographic data were collected. Patients were stratified according to the Nelson's glaucoma staging system as mild, moderate and advanced glaucoma. All patients filled out the GQL-15 and National Eye Institute Visual Function Questionnaire (NEI-VFQ 25). The GQL-15 was translated following the internationally-accepted methodology, and its psychometric properties were assessed by using classical test theory and Rasch analysis. RESULTS: The mean total score for the GQL-15 was 20.68 +/- 7.31. The Cronbach's alpha coefficient for the whole scale was 0.89 (central and near vision, alpha=0.24; peripheral vision, alpha=0.85; glare and dark adaptation, alpha=0.83). Factor analysis established 4 factors (70.3% of variance): two corresponding to the original factors and two new factors specific for the Serbian population. The GQL-15 score correlated positively with almost all clinical parameters and NEI-VFQ 25 proving good criterion validity. Correlation of the GQL-15 total score on test-retest confirmed appropriate scale reproducibility (rho= 0.96, P lt 0.001). The GQL-15 discriminated well advanced from mild and moderate glaucoma. In Rasch analysis we obtained adequate item (0.95) reliability index. Almost all items had infit and outfit mean squares in the accepted range. CONCLUSION: Serbian version of the GQL-15 demonstrates adequate reliability and validity. This version of the GQL-15 is a valid instrument for evaluation of quality of life among Serbian speaking patients with glaucoma and can be applied in daily clinical work

Identifying Content for the Glaucoma-specific Item Bank to Measure Quality-of-life Parameters

"This is a non-final version of an article published in final form in Khadka J, McAlinden C, Craig JE, Fenwick EK, Lamoureux EL, Pesudovs K. Identifying content for the glaucoma-specific item bank to measure quality-of-life parameters. Journal of Glaucoma . 2015 Jan;24(1):12-9. doi: 10.1097/IJG.0b013e318287ac11.". Author manuscript version made available in accordance with publisher copyright policy.PURPOSE: Patient-reported outcomes (PROs) have become essential clinical trial end points. However, a comprehensive, multidimensional, patient-relevant, and precise glaucoma-specific PRO instrument is not available. Therefore, the purpose of this study was to identify content for a new, glaucoma-specific, quality-of-life (QOL) item bank. METHODS: Content identification was undertaken in 5 phases: (1) identification of extant items in glaucoma-specific instruments and the qualitative literature; (2) focus groups and interviews with glaucoma patients; (3) item classification and selection; (4) expert review and revision of items; and (5) cognitive interviews with patients. RESULTS: A total of 737 unique items (extant items from PRO instruments, 247; qualitative articles, 14 items; focus groups and semistructured interviews, 476 items) were identified. These items were classified into 10 QOL domains. Four criteria (item redundancy, item inconsistent with domain definition, item content too narrow to have wider applicability, and item clarity) were used to remove and refine the items. After the cognitive interviews, the final minimally representative item set had a total of 342 unique items belonging to 10 domains: activity limitation (88), mobility (20), visual symptoms (19), ocular surface symptoms (22), general symptoms (15), convenience (39), health concerns (45), emotional well-being (49), social issues (23), and economic issues (22). CONCLUSIONS: The systematic content identification process identified 10 QOL domains, which were important to patients with glaucoma. The majority of the items were identified from the patient-specific focus groups and semistructured interviews suggesting that the existing PRO instruments do not adequately address QOL issues relevant to individuals with glaucoma

Are Patient Self-Reported Outcome Measures Sensitive Enough to Be Used as End Points in Clinical Trials?: Evidence from the United Kingdom Glaucoma Treatment Study

Purpose The United Kingdom Glaucoma Treatment Study (UKGTS) demonstrated the effectiveness of an intraocular pressure-lowering drug in patients with glaucoma using visual field progression as a primary outcome. The present study tested the hypothesis that responses on patient-reported outcome measures (PROMs; secondary outcome measure) differ between patients receiving a topical prostaglandin analog (latanoprost) or placebo eye drops in UKGTS. Design Multicenter, randomized, triple-masked, placebo-controlled trial. Participants Newly diagnosed glaucoma patients in the UKGTS with baseline and exit PROMs (n = 182 and n = 168 patients from the treatment and placebo groups, respectively). Methods In the UKGTS (trial registration number, ISRCTN96423140), patients with open-angle glaucoma were allocated to receive latanoprost (treatment) or placebo; the observation period was 24 months. Patients completed general health PROMs (European Quality of Life in 5 Dimensions [EQ-5D] and 36-item Short Form [SF-36]) and PROMs specific to glaucoma (15-item Glaucoma Quality of Life [GQL-15] and 9-item Glaucoma Activity Limitation [GAL-9]) at baseline and exit from the trial. Percentage changes between measurement on PROMs were calculated for each patient and compared between treatment arms. In addition, differences between stable patients (n = 272) and those with glaucomatous progression (n = 78), as determined by visual field change (primary outcome), were assessed. Main Outcome Measure PROMs on health-related and vision-related quality of life. Results Average percentage change on PROMs was similar for patients in both arms of the trial, with no statistically significant differences between treatment and placebo groups (EQ-5D, P = 0.98; EQ-5D visual analog scale, P = 0.88; SF-36, P = 0.94, GQL-15, P = 0.66; GAL-9, P = 0.87). There were statistically significant differences between stable and progressing patients on glaucoma-specific PROMs (GQL-15, P = 0.02; GAL-9, P = 0.02), but not on general health PROMs (EQ-5D, P = 0.62; EQ-5D visual analog scale, P = 0.23; SF-36, P = 0.65). Conclusions Average change in PROMs on health-related and vision-related quality of life was similar for the treatment and placebo groups in the UKGTS. The PROMs used may not be sensitive enough to function as primary end points in clinical trials when participants have newly diagnosed early-stage glaucoma

Are Patient Self-Reported Outcome Measures Sensitive Enough to Be Used as End Points in Clinical Trials? Evidence from the United Kingdom Glaucoma Treatment Study

PURPOSE: The United Kingdom Glaucoma Treatment Study (UKGTS) demonstrated the effectiveness of an intraocular pressure-lowering drug in patients with glaucoma using visual field progression as a primary outcome. The present study tested the hypothesis that responses on patient-reported outcome measures (PROMs; secondary outcome measure) differ between patients receiving a topical prostaglandin analog (latanoprost) or placebo eye drops in UKGTS. DESIGN: Multicenter, randomized, triple-masked, placebo-controlled trial. PARTICIPANTS: Newly diagnosed glaucoma patients in the UKGTS with baseline and exit PROMs (n = 182 and n = 168 patients from the treatment and placebo groups, respectively). METHODS: In the UKGTS (trial registration number, ISRCTN96423140), patients with open-angle glaucoma were allocated to receive latanoprost (treatment) or placebo; the observation period was 24 months. Patients completed general health PROMs (European Quality of Life in 5 Dimensions [EQ-5D] and 36-item Short Form [SF-36]) and PROMs specific to glaucoma (15-item Glaucoma Quality of Life [GQL-15] and 9-item Glaucoma Activity Limitation [GAL-9]) at baseline and exit from the trial. Percentage changes between measurement on PROMs were calculated for each patient and compared between treatment arms. In addition, differences between stable patients (n = 272) and those with glaucomatous progression (n = 78), as determined by visual field change (primary outcome), were assessed. MAIN OUTCOME MEASURE: PROMs on health-related and vision-related quality of life. RESULTS: Average percentage change on PROMs was similar for patients in both arms of the trial, with no statistically significant differences between treatment and placebo groups (EQ-5D, P = 0.98; EQ-5D visual analog scale, P = 0.88; SF-36, P = 0.94, GQL-15, P = 0.66; GAL-9, P = 0.87). There were statistically significant differences between stable and progressing patients on glaucoma-specific PROMs (GQL-15, P = 0.02; GAL-9, P = 0.02), but not on general health PROMs (EQ-5D, P = 0.62; EQ-5D visual analog scale, P = 0.23; SF-36, P = 0.65). CONCLUSIONS: Average change in PROMs on health-related and vision-related quality of life was similar for the treatment and placebo groups in the UKGTS. The PROMs used may not be sensitive enough to function as primary end points in clinical trials when participants have newly diagnosed early-stage glaucoma

Glaucoma Symptom Scale: Psychometric properties of the Serbian version

Purpose The study aim was to translate and validate the Glaucoma Symptom Scale (GSS) in Serbian language. Methods Clinical parameters and socio-demographic data were collected for each of the 177 enrolled glaucoma patients. Each eye was classified according to the Glaucoma staging system by Mills into 6 stages. Patients filled out the GSS and National Eye Institute Visual Function Questionnaire (NEI-VFQ 25). The GSS comprises 10 complaints common for glaucoma patients on a topical treatment, grouped into two subscales: SYMP-6 (non-visual) and FUNC-4 (visual problems). The GSS was translated following the customary methodology and its psychometric properties were assessed by using both Classical Test Theory (CTT) and Rasch analysis. Results The internal consistency of the Serbian GSS for the whole scale was very good (Cronbach's alpha = 0.81). On factor analysis items were clustered into 2 factors (48.92% of variance) which corresponded to the original scale. The total and subscale GSS scores correlated significantly with measures of disease severity and also with total score and analogous NEI-VFQ 25 subscale scores. In Rasch analysis we obtained adequate item reliability index (0.90). Almost all items had infit and outfit mean squares in the accepted range. However, measurement precision was poor (low person separation reliability) and targeting revealed a ceiling effect. Conclusion When analyzed with CTT the Serbian version of the GSS seems to be a valid instrument, but Rasch analysis revealed some serious measurement flaws, therefore it should not be used in its current format. Further studies to modify and improve GSS are needed prior to its application for Serbian glaucoma patients

Reengineering Critical Access Hospitals into Medical Homes: An Administrative Case Study

Across this nation, rural hospitals are closing at an alarming rate. The critical access hospital designation was created in 1997 (Balanced Budget Act, 1997) to assist the rural facilities in remaining solvent with increased cash-flows on a cost reimbursement basis. The Swing Bed program was also launched in 1980 (Silverman, 1990) to assist the rural facilities by increasing their average daily census. This skilled nursing program was created for step down treatment of patients who were not ready to be discharged “home”. These Federal programs, such as the Omnibus Reconciliation Act of 1980 (Public Law 96-499) were developed to assist in keeping these rural healthcare facilities in operation. However, they have not, and could not have solved all of the problems associated with these organizations. The lack of knowledgeable and effective leadership at the Chief Executive Officer level is a root cause for many of the critical access hospital closures. Therefore, this administrative case study was developed to describe a promising new business model to ameliorate the problems affecting the viability of critical access hospitals. The model has the following components: 1) Identifying the facilities that can be “saved” and the critical attributes associated with the identification of survival risk for these organizations; and 2) reengineering of these hospitals to function as Patient-Centered Medical Homes. These two steps are at the core of this administrative case study. The major assumption underlying the approach is that the development of these hospitals into Medical Homes will prove to be an effective solution to returning these facilities to financially and operationally healthy organizations. An essential aspect of the reengineering of a hospital is the metrics that are implemented and used to summarize the process. We describe the types of empirical data collected, quantitative analysis, and the planned tools needed for qualitative analysis. Only the initial assessments and the plans for future assessments are described here because the process is expected to continuously evolve over a three to five year time period. Thus, only the future will show if this approach is truly effective

The Importance of Rating Scale Design in the Measurement of Patient-Reported Outcomes Using Questionnaires or Item Banks

This article is made available with the permission of the publisher, Association for Research in Vision and OphthalmologyPurpose.: To investigate the effect of rating scale designs (question formats and response categories) on item difficulty calibrations and assess the impact that rating scale differences have on overall vision-related activity limitation (VRAL) scores. Methods.: Sixteen existing patient-reported outcome instruments (PROs) suitable for cataract assessment, with different rating scales, were self-administered by patients on a cataract surgery waiting list. A total of 226 VRAL items from these PROs in their native rating scales were included in an item bank and calibrated using Rasch analysis. Fifteen item/content areas (e.g., reading newspapers) appearing in at least three different PROs were identified. Within each content area, item calibrations were compared and their range calculated. Similarly, five PROs having at least three items in common with the Visual Function (VF-14) were compared in terms of average item measures. Results.: A total of 614 patients (mean age ± SD, 74.1 ± 9.4 years) participated. Items with the same content varied in their calibration by as much as two logits; “reading the small print” had the largest range (1.99 logits) followed by “watching TV” (1.60). Compared with the VF-14 (0.00 logits), the rating scale of the Visual Disability Assessment (1.13 logits) produced the most difficult items and the Cataract Symptom Scale (0.24 logits) produced the least difficult items. The VRAL item bank was suboptimally targeted to the ability level of the participants (2.00 logits). Conclusions.: Rating scale designs have a significant effect on item calibrations. Therefore, constructing item banks from existing items in their native formats carries risks to face validity and transmission of problems inherent in existing instruments, such as poor targeting

An Indian effort towards affordable drugs: "generic to designer drugs"

This review discusses the progress of India from being one of the largest producers of generics to its coming of age and initiating novel drug development programs such as the Open Source Drug Discovery for tuberculosis. A few groups have also begun to emerge which focus their research on rational or structure based drug design. We discuss here some of the ongoing efforts in drug discovery in India primarily in national research institutions and academia

Factors associated with delayed first ophthalmological consultation for primary glaucoma: a qualitative interview study

BackgroundGlaucoma has an insidious onset with non-specific early symptoms, often leading patients to delay in seeking help. However, postponing the first ophthalmological consultation can result in delayed diagnosis and treatment, with adverse effects on vision. This study explored the factors associated with delayed first ophthalmological consultation in patients with primary glaucoma, with the overarching aim of informing measures to reduce delayed consultation and avoid the consequent adverse outcomes.MethodsWe adopted a phenomenological approach. Semi-structured interviews were conducted with patients admitted to a tertiary eye hospital in Tianjin, China, from January 2021 to April 2021. Data were analyzed by Colaizzi’s seven-step method.ResultsWe identified 46 patients with primary glaucoma who delayed their first ophthalmological consultation for various reasons. There were four major themes and 16 sub-themes. The major themes were as follows: (1) occult symptoms that are difficult to identify; (2) insufficient knowledge and understanding of glaucoma-related risks and harm; (3) perceived difficulties in accessing medical care; and (4) inadequate support system.ConclusionIn order to avoid patient delay and consequent irreversible damage to the visual field in patients with primary glaucoma, it is essential that medical staff identify symptoms more effectively, change habitual medical behavior of the patients, adopt a medical union model, and promote the use of a social medical support system to address practical difficulties in delivering adequate care

Recent Developments and Applications in Tissue Mechanics and Tissue Engineering

Tissue mechanics and tissue engineering are multidisciplinary and interconnected fields that are studied at multiple scales by integrating knowledge in biology, solid mechanics, fluid dynamics, finite element modeling, imaging, electronics, automation, and design. Experimental, computational, and combined approaches are often used to investigate the structure–function relationships in tissues and to understand how their mechanics and biological pathways are altered in injury, disease, or regeneration. The objective of this Special Issue is to present recent methods for the investigation of tissue mechanics and tissue engineering or for combined research between the two fields