Alan Davidson, Josip Biskic, John Markovski

Three icons of the game of soccer in Australia. Alan Davidson (left), Josip Biskic (centre) and John Markovski of Preston (right). c.1980s.

Developing a placebo-controlled trial in surgery : issues of design, acceptability and feasibility

Background: Surgical placebos are controversial. This in-depth study explored the design, acceptability, and feasibility issues relevant to designing a surgical placebo-controlled trial for the evaluation of the clinical and cost effectiveness of arthroscopic lavage for the management of people with osteoarthritis of the knee in the UK.
Methods: Two surgeon focus groups at a UK national meeting for orthopaedic surgeons and one regional surgeon focus group (41 surgeons); plenary discussion at a UK national meeting for orthopaedic anaesthetists (130 anaesthetists); three focus groups with anaesthetists (one national, two regional; 58 anaesthetists); two focus groups with members of the patient organisation Arthritis Care (7 participants); telephone interviews with people on consultant waiting lists from two UK regional centres (15 participants); interviews with Chairs of UK ethics committees (6 individuals); postal surveys of members of the British Association of Surgeons of the Knee (382 surgeons) and members of the British Society of Orthopaedic Anaesthetists (398 anaesthetists); two centre pilot (49 patients assessed).
Results: There was widespread acceptance that evaluation of arthroscopic lavage had to be conducted with a placebo control if scientific rigour was not to be compromised. The choice of placebo surgical procedure (three small incisions) proved easier than the method of anaesthesia (general anaesthesia). General anaesthesia, while an excellent mimic, was more intrusive and raised concerns among some stakeholders and caused extensive discussion with local decision-makers when seeking formal approval for the pilot. Patients were willing to participate in a pilot with a placebo arm; although some patients when allocated to surgery became apprehensive about the possibility of receiving placebo, and withdrew. Placebo surgery was undertaken successfully.
Conclusions: Our study illustrated the opposing and often strongly held opinions about surgical placebos, the ethical issues underpinning this controversy, and the challenges that exist even when ethics committee approval has been granted. It showed that a placebo-controlled trial could be conducted in principle, albeit with difficulty. It also highlighted that not only does a placebo-controlled trial in surgery have to be ethically and scientifically acceptable but that it also must be a feasible course of action. The place of placebo-controlled surgical trials more generally is likely to be limited and require specific circumstances to be met. Suggested criteria are presented.

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 α 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.

Relationship between vision impairment and ability to perform activities of daily living

Purpose: To determine the relationship between clinical measures of vision impairment and the ability to perform activities of daily living (ADLs).

Methods: One hundred and twenty subjects with low vision from a variety of causes participated in the study. Vision impairment was assessed under binocular conditions by measuring distance visual acuity, near word acuity, Melbourne Edge Test contrast sensitivity, Pelli–Robson Chart contrast sensitivity and visual fields. The ADL performance was assessed using the Melbourne Low Vision ADL Index (MLVAI), which is in part an observed performance assessment of instrumental ADLs and in part a self-report assessment of basic self-care ADLs.

Results: All vision measures had a high, statistically significant correlation with MLVAI total score. Near word acuity, had the strongest correlation (rs=−0.86, p < 0.001), followed by Melbourne Edge Test contrast sensitivity (rs=0.80, p < 0.001). Visual field had the weakest correlation (rs=0.56, p < 0.001). Together, age, near word acuity, Melbourne Edge Test contrast sensitivity and visual field accounted for 82.2% (adjusted R2, p < 0.001) of the variance in MLVAI total score. All correlations obtained were higher for the observed performance assessment of instrumental ADLs than for the self-report assessment of basic self-care ADLs.

Conclusions: Clinical vision impairment measures are highly correlated with capacity to perform ADLs, as measured by the MLVAI.

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.

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 (MLVAIW) 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 MLVAIW score. Near-word acuity had the strongest correlation (rs = 0.78, p < 0.001), followed by Melbourne Edge Test contrast sensitivity (rs = -0.72, p < 0.001). Visual field had the weakest correlation (rs = -0.52, p < 0.001). The best predictive model of MLVAIW score incorporated the variables age, near-word acuity, and visual field. Together, these variables accounted for 65.1% of the variance in MLVAIW score.

Conclusions. The MLVAI is highly valid and reliable when weighted by a scale that reflects the personal importance of ADL's. The MLVAIW 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 MLVAIW should be kept separate to facilitate the clear interpretation of the outcomes of low-vision rehabilitation.

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.

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 in-doors, were of no value in predicting outdoor mobility performance.