Abstract: Displaced four-part fractures comprise 2-10 % of all proximal humeral fractures. The optimal treatment is unclear and randomised trials are needed. The conduct and interpretation of such trials is facilitated by a reproducible fracture classification. We aimed at quantifying observer agreement on the classification of displaced four-part fractures according to the Neer system. Published and unpublished data from five observer studies were reviewed. Observers agreed less on displaced four-part fractures than on the overall Neer classification. Mean kappa values for interobserver agreement ranged from 0.16 to 0.48. Specialists agreed slightly more than fellows and residents. Advanced imaging modalities (CT and 3D CT) seemed to contribute more to classification of displaced four-part patterns than in less complex fracture patterns. Low observer agreement may challenge the clinical approach to displaced four-part fractures and poses a problem for the interpretation and generalisation of results from future randomised trials.
Abstract: BACKGROUND: Fractures of the proximal humerus are common injuries and account for 4-5 percent of all fractures, second only to hip and wrist fractures. The incidence is positively correlated with age and osteoporosis, and is likely to increase. Displaced four-part fractures are among the most severe injuries, accounting for 2-10 percent of proximal humeral fractures. The optimal intervention is disputed. Two previous randomised trials were very small and involved a noticeable risk of bias, and systematic reviews consequently conclude that there is inadequate basis for evidence-based treatment decisions. We aim to compare the effect of osteosynthesis with angle-stable plate with non-surgical management, and the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management. METHODS/DESIGN: We will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two-year period. We plan to include 162 patients. A central randomisation unit will allocate patients. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy regardless of treatment allocation. Patients will be followed at least one year. The primary outcomes will be the overall score on the Constant Disability Scale, and its pain subscale, measured at 12 months. A blinded physiotherapist will carry out the assessments. Other secondary outcomes are Oxford Shoulder Score, and general health status (Short Form-36).
Abstract: Fractures of the humerus have challenged medical practitioners since the beginning of recorded medical history. In the earliest known surgical text, The Edwin Smith Papyrus (copied circa 1600 BC), three cases of humeral fractures were described. Reduction by traction followed by bandaging with linen was recommended. In Corpus Hippocraticum (circa 440-340 BC), the maneuver of reduction was fully described: bandages of linen soaked in cerate and oil were applied followed by splinting after a week. In The Alexandrian School of Medicine (third century BC), shoulder dislocations complicated with fractures of the humerus were mentioned and the author discussed whether the dislocation should be reduced before or after the fracture. Celsus (25 BC-AD 50) distinguished shaft fractures from proximal and distal humeral fractures. He described different fracture patterns, including transverse, oblique, and multifragmented fractures. In Late Antiquity, complications from powerful traction or tight bandaging were described by Paul of Aegina (circa AD 625-690). Illustrations from sixteenth and seventeenth century surgical texts are included to show the ancient methods of reduction and bandaging. The richness of written sources points toward a multifaceted approach to the diagnosis, reduction, and bandaging of humeral fracture in Ancient Egypt, Greece, and Rome.
Abstract: BACKGROUND: Multiple chemical sensitivity (MCS) is a descriptive term covering symptoms attributed to exposure to common airborne chemicals. There are no internationally accepted criteria, but it has been suggested that MCS is a chronic and disabling condition. However, details of the impact of MCS on everyday life are limited. OBJECTIVE: To describe the impact of MCS on everyday life, strategies for managing the condition, and experiences with healthcare management. METHODS: A focus group study was conducted, including two interviews with a sample of six women and six men between 27 and 78 years of age, a duration of MCS of at least 1 year, and with different occupational conditions. RESULTS: MCS may severely influence different aspects of everyday life, including lifestyle, social relations, and occupational conditions. Avoiding common airborne chemicals was the most prevalent coping strategy, which implied creating a chemical-free living space and limiting social activities. Experiences with healthcare management were overall reported as negative in terms of not receiving acknowledgement of the reported symptoms. CONCLUSIONS: MCS may have serious implications for daily functioning. Further research on individual consequences and the social and psychological factors that may be associated with MCS is needed in order to add to our understanding of this condition and to the provision of more satisfactory healthcare.
Abstract: OBJECTIVE: To systematically review studies of observer agreement among doctors classifying proximal humeral fractures according to the Neer system. STUDY DESIGN AND SETTING: A systematic review. We searched for observational studies in which doctors classified proximal humeral fractures according to the Neer system, and randomized trials of any intervention aimed at improving agreement. We analyzed potential eligible studies independently, and data were extracted using pretested forms. Authors were contacted for missing information. Summary statistics for observer agreement were noted, and the methodological quality was assessed. RESULTS: We included 11 observational studies (88 observers and 468 cases). Mean kappa-values for interobserver agreement ranged from 0.17 to 0.52. Agreement did not improve through selection of experienced observers, advanced imaging modalities, or simplification of the classification system. Intra-observer agreement was moderately higher than interobserver agreement. One randomized trial (14 observers and 42 cases) reported a clear effect of training (mean kappa-value 0.62 after training compared to no training 0.34). CONCLUSION: We found a consistently low level of observer agreement. The widely held belief that experts disagree less than nonexperts could not be supported. One randomized trial indicated that training improves agreement among both experts and nonexperts.
Abstract: BACKGROUND: Blinding can reduce bias in randomized clinical trials, but blinding procedures may be unsuccessful. Our aim was to assess how often randomized clinical trials test the success of blinding, the methods involved and how often blinding is reported as being successful. METHODS: We analysed a random sample of blinded randomized clinical trials indexed in the The Cochrane Central Register of Controlled Trials and published in 2001. We identified 1599 blinded trials, and noted if they had conducted any test for the success of blinding. We also selected 200 trials randomly that did not report any such test, and sent a questionnaire to the corresponding authors asking them if they had conducted any tests. RESULTS: Thirty-one out of 1599 trials (2%) reported tests for the success of blinding. Test methods varied, and reporting was generally incomplete. Blinding was considered successful in 14 out of the 31 trials (45%) and unclear in 10 (32%). Of the seven trials (23%) reporting unsuccessful blinding the risk of a biased trial result was either not addressed or was discounted in six cases. We received 130 questionnaires from trial authors (65%) of which 15 (12%) informed that they had conducted, but not published, tests. CONCLUSIONS: Blinding is rarely tested. Test methods vary, and the reporting of tests, and test results, is incomplete. There is a considerable methodological uncertainty how best to assess blinding, and an urgent need for improved methodology and improved reporting.
Abstract: The Polish microbiologist and philosopher of science, Ludwik Fleck (1896-1961), was a pioneer in constructivist history and philosophy of science. Based on studies in the history of syphilis, Fleck hypothesized that many established scientific facts are linked, in their development, to pre-scientific "proto-ideas." In 1935, Fleck proposed that the history of germ theories could be approached through his thesis on proto-ideas. His proposal, however, remained little more than a vague suggestion and was never developed in further detail. This paper introduces the concept of proto-ideas and discusses the central epistemological and historiographical implications of Fleck's thesis. The Fleckian approach offers an attractive alternative to positivist reconstructions of the early history of germ theories and provides a useful framework for a deeper understanding of the sociocultural background of the development of modern knowledge of infection.
Abstract: We investigated whether training doctors to classify proximal fractures of the humerus according to the Neer system could improve interobserver agreement. Fourteen doctors were randomised to two training sessions, or to no training, and asked to categorise 42 unselected pairs of plain radiographs of fractures of the proximal humerus according to the Neer system. The mean kappa difference between the training and control groups was 0.30 (95% CI 0.10 to 0.50, p = 0.006). In the training group the mean kappa value for interobserver variation improved from 0.27 (95% CI 0.24 to 0.31) to 0.62 (95% CI 0.57 to 0.67). The improvement was particularly notable for specialists in whom kappa increased from 0.30 (95% CI 0.23 to 0.37) to 0.79 (95% CI 0.70 to 0.88). These results suggest that formal training in the Neer system is a prerequisite for its use in clinical practice and research.
Abstract: Twenty-four orthopaedic surgeons classified 42 pairs of radiographs according to the Neer system for proximal humeral fractures. Mean kappa value for inter-observer agreement was 0.27 (95% CI 0.26-0.28) with no clinically significant difference between orthopaedic residents ( n=9), fellows ( n=6) and specialists ( n=9). Mean kappa for agreement of displacement versus non-displacement was 0.41 (95% CI 0.39-0.43) overall, and 0.50 (95% CI 0.45-0.56) within the specialist group. The agreement found in our study is unsatisfactory from a clinical perspective.
Abstract: 'Proto-idea' was a central concept in the thinking of the Polish microbiologist and philosopher of science Ludwik Fleck (1896-1961). Based on studies of the origin of the modern concept of syphilis, Fleck claimed that many established scientific facts are best understood as interpretations of prescientific, somewhat hazy 'proto-ideas' in the framework of a certain 'thought-style'. As an example, Fleck saw the modern knowledge of infection as an interpretation of the ancient proto-idea of diseases as caused by minute 'animalcules'. However, the epistemological aspects of the concept of proto-ideas have only been sparsely developed and discussed by Fleck and his critics. This paper attempts to bridge the gap. Firstly, I reconstruct the concept of proto-ideas in the context of Fleck's constructivist theory of knowledge. Secondly, I illustrate the relation between Fleck's concept of proto-ideas and his nominalist view on medical taxonomy. Finally, I discuss four philosophical problems implied by Fleck's concept of proto-ideas: (a) the problem of combining two conflicting perspectives on the history of science (b) the problem of accounting for the notion of 'continuity' within a nonrealist theory of knowledge (c) the problem of ascribing no truth-content to proto-ideas, and (d) the problem concerning the non-neutrality of the analyst's viewpoint.
