Cross-cultural validation and analysis of responsiveness of the QUALIOST(®): QUAlity of Life questionnaire In OSTeoporosis

BACKGROUND: The QUALIOST(® )was designed for use with the SF-36 to measure established osteoporosis-specific quality of life (QoL). The reliability (internal consistency and test-retest) and validity of the questionnaire were established in a stand-alone psychometric validation study. The objective of this paper is to provide additional information on the instrument's responsiveness using clinical trial data, along with the reliability and validity of translated versions. METHODS: The Spinal Osteoporosis Therapeutic Intervention (SOTI) was an international clinical trial comparing strontium ranelate to placebo on the occurrence of new vertebral fracture in patients with postmenopausal osteoporosis. QoL was a secondary endpoint, assessed using the SF-36 and QUALIOST(® )at baseline and every six months, with the main analysis at 3-year follow-up. Questionnaire acceptability, analysis of the hypothesised structure, internal consistency reliability and responsiveness to clinical change over time were assessed at the 3-year follow up. RESULTS: 1592 patients from 11 countries completed at least one QoL questionnaire. The psychometric properties of the questionnaires were assessed on cross-sectional (N = 1486) and longitudinal (N = 1288) data. Item discriminant validity of the QUALIOST(® )was excellent, as was item convergent validity, with 100% of item-scale correlations being above the 0.40 level. Internal consistency reliability was also extremely good, with high Cronbach's alpha scores above the 0.70 benchmark. Responsiveness results were consistent for all QUALIOST(® )scores, indicating that greater decreases in QoL corresponded to greater numbers of fractures experienced. QUALIOST(® )scores also differed according to the type of fracture suffered. This was demonstrated by increased effect sizes for more severe vertebral fractures (clinical vertebral and painful vertebral). In comparing responsiveness, the QUALIOST(® )scores were generally more consistent than those of the SF-36. Most notably, the QUALIOST(® )was more responsive with regard to painful vertebral fractures than the SF-36. CONCLUSION: The QUALIOST(® )is a reliable and valid tool for measuring QoL in postmenopausal osteoporotic women. Being available in several validated language versions, it is ready to be used in a variety of settings, including international clinical trials

A pragmatic patient-reported outcome strategy for rare disease clinical trials: application of the EORTC item library to myelodysplastic syndromes, chronic myelomonocytic leukemia, and acute myeloid leukemia.

BackgroundNovel, pragmatic, patient-centered strategies are needed to ensure fit-for-purpose patient-reported outcomes (PRO) instruments in clinical trial research for rare diseases such as myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML). The objective of the current study was to select supplemental items to add to the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 (QLQ-C30) to ensure content coverage of all important clinical concepts in patients with higher-risk (HR) MDS, low-blast count (LB) AML, and CMML, thus, improving the instrument's ability to detect clinically meaningful treatment benefit for this context of use.MethodsOur mixed methods approach comprised literature review, clinician consultation (n = 3), and qualitative and quantitative analysis of two stages of patient interview data (n = 14, n = 18) to select library bank items to supplement a generic cancer PRO, the EORTC QLQ-C30.ResultsUnique symptom (n = 54) and impact (n = 72) concepts were organized into conceptual frameworks of treatment benefit, compared with EORTC QLQ-C30 items and conceptual gaps identified. Supplemental items (n = 13) addressing those gaps were selected from the EORTC Item Library and tested with patients. Supplemental item endorsement frequencies met World Health Organization Quality of Life criteria, suggesting good targeting and relevance for this sample. However, three supplemental items were confirmed as problematic based upon cognitive debriefing results, and expert clinical consultations. Ultimately, 10 supplemental items (n = 7 symptom; n = 3 impact) were selected for the MDS/AML/CMML context.ConclusionSupplemental items were selected to enhance the conceptual coverage of the EORTC QLQ-C30 in the areas of fatigue, shortness of breath, and functioning

Combine harvesters in Missouri

Cover title.Includes bibliographical references

Corn tillage studies on rolling Putnam silt loam

Cover title

Histological localization of binding sites of [alpha]-bungarotoxin and of antibodies specific to acetylcholine receptor in goldfish optic nerve and tectum

Goldfish optic nerve as well as ganglion cell neurites grown in culture selectively bind rhodamine-labeled [alpha]-bungarotoxin following tissue fixation. Binding is competed for by unlabeled bungarotoxin, by carbamylcholine and tubocurarine, but not by atropine. In cross-sections, the label is seen confined to axonal bundles. The binding is not detectable without prior fixation and is very faint in brain sections, even after fixation.To further establish the nature of the binding, immunocytochemical studies were performed, taking advantage of a high cross-reactivity found between goldfish brain and antibodies against eel acetylcholine receptor (AChR). Antigenic sites were detected by an indirect unlabeled antibody complexed to horseradish peroxidase. Anti-AChR antibody binding to optic nerve and neurites in culture correlated with that seen with [alpha]-bungarotoxin. Binding of anti-AChR was observed in the brain, and was reduced in the denervated tectum following unilateral optic nerve crush or enucleation.The results are discussed in relation to functions of receptor proteins in the retinotectal system.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/23195/1/0000122.pd

Angiographic predictors of recurrence of restenosis after Wiktor stent implantation in native coronary arteries

Intracoronary stenting has been proposed as an adjunct to balloon angioplasty to improve the immediate and long-term results. However, late luminal narrowing has been reported following the implantation of a variety of stents. One of the studies conducted with the Wiktor stent is a prospective registry designed to evaluate the feasibility, safety and efficacy of elective stent implantation in patients with documented restenosis of a native coronary artery. To identify angiographic variables predicting recurrence of restenosis, the angiograms of the first 91 patients with successful stent implantation and without clinical evidence of (sub)acute thrombotic stent occlusion were analyzed with the Computer Assisted Angiographic Analysis System using automated edge detection. The incidence of restenosis was 44% by patient and 45% by stent according to the 0.72 mm criterion, and 30% by patient and 29% by stent according to the 50% diameter stenosis criterion. The risk for restenosis for several angiographic variables was determined using an univariate analysis and is expressed as odds ratio with corresponding confidence interval. The only statistically significant predictor of restenosis was the relative gain when it exceeded 0.48 using the 0.72 mm criterion (odds ratio 2.7, 95% confidence interval 1.1-6.4). Furthermore, the relation between the relative gain (increase in minimal luminal diameter normalized to vessel size) as angiographic index of vessel wall injury and relative loss (decrease in minimal luminal diameter normalized to vessel size) as index of neointimal thickening was analyzed using a linear regression analysis. When using the categorical approach to address restenosis, there is an increased risk for recurrent restenosis when the relative gain exceeds 0.48. The continuous approach underscores this concept by indicating a weak but positive relation between the relative gain and relative loss

Addressing the targeting range of the ABILHAND-56 in relapsing-remitting multiple sclerosis: A mixed methods psychometric study.

Background: ABILHAND, a manual ability patient-reported outcome instrument originally developed for stroke patients, has been used in multiple sclerosis clinical trials; however, psychometric analyses indicated the measure\u27s limited measurement range and precision in higher-functioning multiple sclerosis patients. Objective: The purpose of this study was to identify candidate items to expand the measurement range of the ABILHAND-56, thus improving its ability to detect differences in manual ability in higher-functioning multiple sclerosis patients. Methods: A step-wise mixed methods design strategy was used, comprising two waves of patient interviews, a combination of qualitative (concept elicitation and cognitive debriefing) and quantitative (Rasch measurement theory) analytic techniques, and consultation interviews with three clinical neurologists specializing in multiple sclerosis. Results: Original ABILHAND was well understood in this context of use. Eighty-two new manual ability concepts were identified. Draft supplementary items were generated and refined with patient and neurologist input. Rasch measurement theory psychometric analysis indicated supplementary items improved targeting to higher-functioning multiple sclerosis patients and measurement precision. The final pool of Early Multiple Sclerosis Manual Ability items comprises 20 items. Conclusion: The synthesis of qualitative and quantitative methods used in this study improves the ABILHAND content validity to more effectively identify manual ability changes in early multiple sclerosis and potentially help determine treatment effect in higher-functioning patients in clinical trials

Development of a gait module to complement the 12-item Multiple Sclerosis Walking Scale: a mixed methods study.

Background and objective: The 12-item Multiple Sclerosis Walking Scale (MSWS-12) is a patient-reported outcome instrument that quantifies the progressive loss of walking ability from the patient perspective. However, previous psychometric analyses indicated floor and ceiling effects across the multiple sclerosis severity spectrum. This study aimed to address floor effects by creating a gait module that can be used in conjunction with the MSWS-12 for better measurement of treatment benefit in the higher functioning multiple sclerosis population. Methods: We used a step-wise mixed methods study design, with relapsing-remitting multiple sclerosis patients (wave 1, Results: Thirty-seven walking ability concepts were identified, and a five-domain conceptual framework was created. Draft items were generated and refined with patient and neurologist input. Draft items covered gait-related concepts such as dragging, shuffling, limping, tripping and falling. Rasch measurement theory psychometric analysis indicated administering MSWS-12 plus gait items improved measurement precision in targeted populations with better walking ability. Conclusion: Study findings indicate that new gait items could improve sensitivity to detect clinical change in walking ability for higher functioning multiple sclerosis patients

Recoil following Wiktor stent implantation for restenotic lesions of coronary arteries

The purpose of this study was to determine acute recoil of the vessel wall immediately after Wiktor stent implantation in native coronary arteries of 77 consecutive patients and to assess whether there was compression or “late recoil” of the stent itself at long-term follow-up. Furthermore, the relationship between recoil and a number of clinical, angiographic, and procedural variables was studied in addition to the relation between acute recoil renarrowing or restenosis was assessed. All angiograms were analyzed with the Cardiovascular Angiography Analysis System using automated edge detection. Acute recoil was defined by the difference between the mean diameter of the fully expanded balloon on which the stent was mounted and the mean diameter of the stented segment. Late recoil was calculated by comparing the mean diameter of the stent itself immediately after implantation and at follow-up without opacification of the vessel. Acute recoil amounted to 0.25 ± 0.32 mm or 8.2%. Multivariate analysis identified sex (coefficient = –0.20, p = 0.04) and stent/artery ratio (coefficient = 0.99, p = 0.0001) as the only independent predictors of acute recoil. “Late recoil” of the stent itself was not observed. The overall difference between the mean diameter of the stent itself immediately after implantation and at follow-up was –0.15 ± 0.33 mm, suggesting an overall increase in diameter of 5.0%. There was no relation between acute recoil and late restenosis. On the contrary, there was a trend towards a greater degree of recoil in patients without restenosis. Moreover, linear regression analysis disclosed a weak but negative correlation between acute recoil and a loss in minimal luminal diameter (coefficient: –0.55, p = 0.04). The Wiktor stent effectively scaffolds the instrumented vessel. Only a minimal amount of acute recoil was noted, which did not contribute to late luminal renarrowing or restenosis. In addition, no late compression of the stent itself was observed. These data suggest that tissue ingrowth into the lumen of the stented segment is the main cause of late luminal renarrowing after stent implantation. © 1994 Wiley-Liss,Inc.