Allergy immunotherapies for allergic rhinitis: systematic review and assessment of evolving quality.

Summary: Background. Heterogeneity in the design and quality of trials evaluating allergy immunotherapies (AITs) limits their comparability, making it difficult for physicians, patients, and payers to select the best treatment option. Methods. This systematic review evaluated the quality of randomised controlled trials (RCTs) of registered grass AITs using the National Institute of Health and Care Excellence checklist. Results. 17 of 44 unique RCTs (38.6%) (sample size range: 18-1,501 subjects) were subcutaneous grass immunotherapy trials and 27 (61.4%) were sublingual grass immunotherapy trials (Allergovit, 5 trials; Alutard, 8; Grazax, 13; Oralair, 6; Staloral, 8; Pollinex, 2; Phostal and Purethal, 1 each). Three trials (6.8%; all Grazax) fulfilled every quality criterion. Quality assessments revealed inconsistencies in study quality and reporting. Study quality trended towards improvement over time, particularly after 2009. Conclusions. When as-sessing grass AIT, it is important to focus not only on endpoints but also on the quality of evidence.

A weighted version of the Melbourne Low-Vision ADL Index: a measure of disability impact.

OBJECTIVE: To develop a version of the Melbourne Low-Vision ADL Index that measures the personal impact of disability in activities of daily living (ADL's). Also, to determine the relationship between clinical measures of vision impairment and disability impact. METHODS: The Melbourne Low-Vision ADL Index (MLVAI) is a desk-based clinical assessment of disability in ADL's. Ability to perform each item is rated on a five-level descriptive scale from zero to four. In this study, the original version of the MLVAI was modified to measure disability impact. The simple modification involved weighting each item by the importance of that item to the person being tested. Importance was also rated on a five-level scale from zero to four. The validity and reliability of the Weighted Melbourne Low-Vision ADL Index (MLVAI(W)) was determined for 97 vision-impaired subjects in a cross-sectional study. RESULTS: Cronbach's alpha coefficient indicated an internal reliability of 0.94, and an intraclass correlation coefficient indicated an overall reliability of 0.88. The standard error of measurement was 24.7 points (out of a possible score of 400). There was a statistically significant difference in test scores between normal subjects and vision-impaired subjects. All vision measures had a high, statistically significant correlation with MLVAI(W) score. Near-word acuity had the strongest correlation (r(s) = 0.78, p < 0.001), followed by Melbourne Edge Test contrast sensitivity (r(s) = -0.72, p < 0.001). Visual field had the weakest correlation (r(s) = -0.52, p < 0.001). The best predictive model of MLVAI(W) score incorporated the variables age, near-word acuity, and visual field. Together, these variables accounted for 65.1% of the variance in MLVAI(W) score. CONCLUSIONS: The MLVAI is highly valid and reliable when weighted by a scale that reflects the personal importance of ADL's. The MLVAI(W) can provide information over and above that obtained with the usual clinical vision measures and may be used to assess low-vision patients and to measure low-vision rehabilitation outcomes. It is suggested that the assessment of disability using the original MLVAI and the assessment of the impact of disability using the MLVAI(W) should be kept separate to facilitate the clear interpretation of the outcomes of low-vision rehabilitation.

Preliminary investigation of the responsiveness of the Melbourne Low Vision ADL index to low-vision rehabilitation.

PURPOSE: To conduct a preliminary investigation on the ability of the Melbourne Low Vision ADL Index to detect changes in functional ability as a result of low-vision rehabilitation. METHODS: Twenty two subjects with age-related macular degeneration (ARMD) who were newly referred to the Kooyong Low Vision Clinic were recruited. The Melbourne Low Vision ADL Index was administered prerehabilitation and postrehabilitation. Changes in scores and effect size statistics were analyzed. RESULTS: The median total score for the subjects prerehabilitation was 67, and the median total score postrehabilitation was 76. The difference in prerehabilitation and postrehabilitation scores was statistically significant (Wilcoxon signed rank test = 248.5, p < 0.001). The mean change score for the total Melbourne Low Vision ADL Index was 9.3 (SD, 5.6). Thus the overall effect size statistic (mean change score divided by SD of prerehabilitation score) was 0.78. CONCLUSIONS: This preliminary investigation indicates that the Melbourne Low Vision ADL Index is responsive to a rehabilitation program for patients with ARMD. It has potential to be used as a measure of low-vision rehabilitation outcomes.

The development of the Melbourne low-vision ADL index: a measure of vision disability.

PURPOSE: To develop a new test of activities of daily living (ADLs) appropriate for the low-vision population: the Melbourne Low-Vision ADL Index (MLVAI). METHODS: The MLVAI was designed as a desk-based clinical assessment, comprising 18 observed items on complex ADLs in part (a) and 9 questions on broad self-care ADLs in part (b). Each item was rated on a five-level descriptive scale from 0 to 4, based on independence, speed, and accuracy of performance. It was designed to be administered under standardized conditions with regard to the instructions, illumination, and working distances. The validity and reliability of the new MLVAI was determined for 122 subjects who were representative of the general low-vision population, in a cross-sectional study. RESULTS: Two items were found to be redundant and were eliminated from the test. Thus, the final test comprised 25 items, with 100 being the highest possible score. Cronbach's alpha indicated an internal reliability of 0.96, and an intraclass correlation coefficient indicated an overall reliability of 0.95. The SE of measurement was 4.5. According to Spearman's correlation coefficient, the test-retest reliability was 0.94 (P < 0.001), and the interpractitioner reliability for five different pairs of practitioners was 0.90 or higher (P < 0.001). With regard to validity, there was a moderately high correlation with vision impairment (r = -0.68, P < 0.001). Using Rasch analysis, content validity was also demonstrated by good separation indexes (4.70 and 9.88) and high reliability scores (0.96 and 0.99) for the person and items parameters, respectively. Separate calculation of indexes and reliability scores for parts (a) and (b) indicated high content validity and reliability of each part. However, the separation indexes and reliability scores were higher for part (a) than for part (b). The correlation coefficient for part (a) and part (b) was 0.68. CONCLUSIONS: The MLVAI is a highly valid and reliable standardized test of ADL performance for the general low-vision population. It may be used to assess patients with low vision and has the potential to be used as a measure of low-vision rehabilitation outcomes.

Evaluation of the chemotherapy patient monitor: an interactive tool for facilitating communication between patients and oncologists during the cancer consultation.

Effective communication between oncologists and patients with cancer is of paramount importance. The Chemotherapy Patient Monitor (CPM) is a novel tool designed to assist doctor-patient communication regarding patient concerns and side-effects. Initially, the CPM was assessed in a primary evaluation study of its use during consultations with 26 patients with advanced colorectal cancer (one consultation without, followed by two with, the CPM per patient). This led to a further dissemination/audit of 34 patients attending oncology centres in the UK, who had completed the survey prior to three consultations. The CPM contains a checklist of common side-effects of chemotherapy regimens used in advanced colorectal cancer, and other common concerns of patients with advanced colorectal cancer. The CPM records the presence of side-effects/concerns, the distress caused, whether patients wish to discuss them further, and actions taken as a result. Questionnaires explored the views of patients and oncologists in the UK and Spain regarding the effectiveness of consultations during a baseline visit conducted without the CPM, and then with the CPM in subsequent visits. These data were then complemented by the dissemination/audit study of the CPM across nine centres in the UK. All patients understood the CPM. The CPM was rated as useful by oncologists in 83% of consultations, and did not lengthen 82% of visits. Patients felt it had improved the visit in 95% of cases. Responses from patients (100%) and oncologists (84%) indicated willingness to use the CPM for at least some consultations in the future. The results of the dissemination/audit study supported these conclusions. We conclude that the CPM appears to be a useful new tool for improving patient-doctor communication during cancer consultations.

Costs incurred by patients undergoing advanced colorectal cancer therapy. A comparison of raltitrexed and fluorouracil plus folinic acid.

BACKGROUND: To assess the cost effectiveness of healthcare interventions from a societal perspective, it is necessary to include costs such as patients' travel costs and the opportunity cost of patients' time spent consuming healthcare. OBJECTIVE: To analyse patients' travel and time costs associated with 2 alternative drug therapies for advanced colorectal cancer: raltitrexed and fluorouracil plus folinic acid (leucovorin) [5FU + FA]. DESIGN AND SETTING: The analysis is based on a prospective substudy within a multinational randomised controlled trial of raltitrexed versus 5FU + FA. PATIENTS AND PARTICIPANTS: 495 patients with advanced colorectal cancer were enrolled in the trial, 270 of whom completed the questionnaire on costs. METHODS: Data were collected within the trial to estimate the numbers of journeys made to and from hospital by patients and the time lost from usual activities over the period of therapy. A subset of patients were asked to complete a questionnaire to provide the information necessary to value time and travel costs in monetary terms. These data, together with UK transport costs and forgone time values, were used to value the transport and opportunity costs of time of all patients in the trial. RESULTS: The total travel cost per patient was statistically significantly higher in the 5FU + FA group (p < 0.001; median of 31.50 Pounds with raltitrexed, 96.00 Pounds with 5FU + FA; 1997 prices). Overall time cost per patient was also higher in the 5FU + FA group (p = 0.005; median of 168.80 Pounds with raltitrexed, 224.04 Pounds with 5FU + FA). Adding the two gives a median total cost per patient of 206.08 Pounds [interquartile range (IQR) 108 Pounds to 482 Pounds] among patients randomised to raltitrexed and 342.25 Pounds (IQR 214 Pounds to 555 Pounds) for those in the 5FU + FA group (p < 0.001). The sensitivity analysis showed that, even under extreme assumptions, raltitrexed imposed fewer time and travel costs on patients. These cost differences are likely, in part, to reflect the longer treatment times for 5FU + FA patients (median 16.9 vs 12.7 weeks). CONCLUSIONS: Different chemotherapy regimens for advanced colorectal cancer can impose different travel and time costs on patients. Over the period of treatment in a randomised controlled trial of 495 patients, those randomised to 5FU + FA were found to have a median travel plus time cost 136 Pounds per patient higher than those randomised to raltitrexed.

Mobility of people with retinitis pigmentosa as a function of vision and psychological variables.

We investigated the mobility performance of subjects with retinitis pigmentosa (RP) as a function of clinical measures of residual vision and psychological variables. We found a highly significant correlation between clinical measures of residual vision and mobility. Pelli-Robson contrast sensitivity and residual visual field together explained 64% of the variance in mobility performance in an indoor shopping mall. We suggest a simple new clinical method of scoring the visual field for predicting mobility performance, the RP Concentric Field Rating. The RP Concentric Field Rating alone explained 60% of the variance in mobility performance. In spite of expectations derived from reading the recent literature, we did not find a significant correlation between psychological variables and mobility performance in a group of subjects with RP.

Psychosocial sequelae of motor vehicle collisions: a follow-up study.

One-hundred-and-forty-nine motor vehicle collision trauma victims were interviewed one year after discharge from a Regional Trauma Unit. Follow-up data indicated major post trauma problems such depression, anxiety, family stress, financial problems and driving fears. Almost 40% reported drinking driving after the crash with a greater proportion of alcohol (blood alcohol content) positive drivers engaging in drinking driving than blood alcohol content negative drivers. Notably, almost 16% of the blood alcohol content positive and 13% of the blood alcohol content negative reported involvement in another crash in the year since discharge.

Comparison of functional mobility performance with clinical vision measures in simulated retinitis pigmentosa.

Simulations of retinitis pigmentosa (RP) under various conditions of retinal illuminance were designed and investigated in order that they might be used in the mobility training of clients with early RP. Goggles incorporating a 2.5 neutral density (ND) filter with a 0.5-mm diameter pinhole were found to be a potentially useful simulation device for this purpose. This investigation also compared mobility performance with clinical vision measures under photopic, mesopic, and scotopic conditions of retinal illuminance. Although none of the clinical vision measures we used was entirely predictive of mobility performance, some measures were better predictors than others. For a severe constriction of the visual field and decreasing retinal illuminance, both edge contrast sensitivity and visual acuity, measured outdoors, accounted for a greater proportion of the variance in mobility performance than did low contrast visual acuity measured under the same circumstances. The same clinical vision measures, taken indoors, were of no value in predicting outdoor mobility performance.

Use of musical scales to display distance to objects in an electronic travel aid for the blind.

An electronic travel aid for the blind has been designed which displays distance to objects in terms of the eight notes of the musical scale. Experiments are described which determine the relationship between the efficacy of various tonal displays and the musical sophistication of the subjects. In particular it is shown that the accuracy of predicting the end of a scale, and hence a collision with an object, is a function of familiarity with the scale. That this accuracy is a function of musical sophistication receives only partial support. As expected, the ascending and descending versions of a scale are, in general, equally effective but, unexpectedly, the hypothesis that the accuracy of predicting the end of a tonal sequence would be an inverse function of the sequence length is confirmed only in the case of one scale, the Ionian or Major scale.

An application of bio-feedback in the rehabilitation of the blind.

The long term blind exhibit diminished awareness of limb position; kinaesthetic feedback alone providing insufficient positional information. Experiments to evaluate simple hand held electronic travel aids for the blind have shown that failure to hold the aid in the correct orientation leads to a failure to detect important hazards. Consequently some potential users may come to reject the aid. Experimental results show that by providing an auditory alarm signal whenever an aid is not held horizontally it is possible to train subjects to maintain the correct holding position. The positive effects of short periods of training with feedback are retained when the feedback is removed. It is proposed to make available a small number of modified (with feedback) aids for use during the early stages of client training.