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Purpose: To determine if use of antiplatelet or anticoagulant (AP/AC) medication influences visual acuity in patients with active neovascular age-related macular degeneration (N-AMD). Design: Retrospective analysis of data from a randomized controlled trial. Methods: SETTING: Multicenter. STUDY POPULATION: Total of 330 patients with active N-AMD from the BRAMD study, a comparative trial between bevacizumab and ranibizumab in the Netherlands. OBSERVATION PROCEDURES: Patients underwent an extensive ophthalmic examination. Visual acuity was categorized into functional vision (best-corrected visual acuity [BCVA] ≥ 0.5), visual impairment (BCVA < 0.5), and severe visual impairment (BCVA < 0.3). Fundus photographs were graded for presence of retinal or subretinal hemorrhages. Information on AP/AC medication was obtained through interview. Logistic regression analysis was used to determine associations between AP/AC medication and outcomes. Frequency of hemorrhages in users and non-users stratified for visual acuity categories was analyzed with ANCOVA. MAIN OUTCOME MEASURES: BCVA and presence of hemorrhages. Results: In total, 40.9% of the patients used AP/AC medication, of which 73.3% was aspirin. AP/AC use was not associated with visual impairment (adjusted odds ratio [OR] 0.79; 95% confidence interval [CI] 0.43-1.44) or severe visual impairment (adjusted OR 0.75; 95% CI 0.40-1.43). Patients on AP/AC presented with comparable frequencies of hemorrhages (27% vs 32%, P =.32, respectively). Similar results were found when analyses were restricted to aspirin users only. Conclusion: In our study, use of AP/AC medication was associated neither with visual decline nor with the occurrence of hemorrhages in patients with active N-AMD.

Selecting the most appropriate outcome measures can be especially burdensome in trials studying fracture healing, because the process of fracture healing is subjective and without a gold standard. Although a wide variety of radiographic modalities are available, plain radiography remains the most common approach for healing assessment. Radiographic criteria, however, do not correlate well with fracture strength and stiffness. Additional challenges include a lack of consensus in what radiographic measures are most appropriate in the assessment of healing. In this article, we provide an overview of the most commonly used radiographic and clinical criteria for defining fracture healing. The validity and reliability of alternative approaches is also discussed.

Background and purpose The impact of large, randomized trials in orthopedic surgery on surgeons' preferences for a particular surgical approach remains unclear. We surveyed surgeons to assess whether they would change practice based upon results of a large, multicenter randomized controlled hip fracture trial.Methods We conducted a cross-sectional survey among International Hip Fracture Research Collaborative (IHFRC) surgeons and surgeons who were members of Arbeitsgemeinschaft fuer Osteosynthesefragen - Association for the Study of Internal Fixation (AO/ASIF) to determine the likelihood that they would change practice based on findings of a proposed large, multicenter randomized controlled trial (the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty (HEALTH) study). We asked surgeons their current preferences for the management of displaced femoral neck fractures and whether a trial that definitively revealed a substantial improvement in function and quality of ...

Summary:Femoral neck fractures account for half of all hip fractures with a rapidly increasing incidence. Since they are associated with high mortality, decrease in quality of life, and high total costs, much research on the optimal treatment of these fractures has been undertaken. In this article

Background Radiographic healing is a common outcome measure in orthopedic trials and adjudication by outcome assessors is often conducted on the basis of plain films alone. The degree to which this process reflects clinical practice, in which both plain films and clinical notes are available, is uncertain. We explored the effect of adding clinical notes to radiographs in the adjudication process of a feasibility trial of tibial shaft fractures. Methods Radiographic and clinical data from a multicenter randomized controlled trial of 51 patients with operatively treated tibial fractures formed the basis of the study data. At the completion of the trial, serial radiographs (anteroposterior and lateral) were independently evaluated for progression of fracture healing, defined as bridging of at least 3 of 4 cortices, by an adjudication committee comprised of 3 blinded orthopaedic trauma surgeons. Immediately after determination of radiographic time to healing, each surgeon was provided with clinical notes associated with each radiographic follow up visit and asked to re-visit their initial impression. Consensus was achieved for both adjudications. We calculated the percentage of time to healing consensus decisions that changed after evaluation of clinical notes. We further examined the contents of clinical notes and their relative influence on the committee's decisions. Results 47 of 51 patients were determined to have healed radiographically during the trial follow-up period, and consideration of clinical notes resulted in a change of 40% (19 of 47) of time to healing consensus decisions; however, revised decisions were equally likely to support an earlier or a later time to healing. Clinical notes that resulted in a change to either a 'healed' or a 'not healed' decision contained significantly more comments of either pain resolution or deterioration, respectively, resumption of or failure to resume weightbearing, or either return or no return to work/pre-injury activities (p < 0.001). Conclusions The addition of clinical notes to the adjudication of radiographic fracture healing changed the outcome decision in a substantial number of cases. Orthopedic trialists should consider the addition of clinical notes to adjudication material in studies of fracture healing in order to enhance the generalizability of their results. Trial Registration The TRUST trial was registered [ID NCT00667849] at http://clinicaltrials.gov/ct2/show/NCT00667849

Item does not contain fulltext In patients with lung cancer, enlarged or (18)Fluoro-deoxyglucose positron emission tomography ((18)FDG-PET) positive left adrenal glands are suspected for distant metastases and require tissue confirmation for a definitive assessment. The aim of this study was to assess the sensitivity of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) for left adrenal metastases in lung cancer patients with a suspect adrenal gland based on imaging. EUS-FNA findings of patients with (suspected) lung cancer and CT enlarged or (18)FDG-PET positive left adrenal glands were retrospectively evaluated. In the absence of metastases at EUS, clinical and radiological follow-up was obtained. In 85 patients, EUS-FNA demonstrated left adrenal metastases of lung cancer in 53 (62%), benign adrenal tissue in 25 (29%), a metastasis from colon carcinoma in 1 (1%) and a primary adrenocortical carcinoma in 1 (1%) patient. In five patients (5.9%), the aspirates contained non-representative material. EUS outcomes were false negative in two patients. Sensitivity and negative predictive value (NPV) for EUS-FNA of the left adrenal gland were at least 86% (95% CI 74-93%) and 70% (95% CI 50-85%). No complications occurred. EUS-FNA is a sensitive, safe and minimally invasive technique to provide tissue proof of left adrenal metastases in patients with (suspected) lung cancer and enlarged or (18)FDG-PET positive adrenal glands. Therefore, EUS-FNA qualifies as the staging test of choice for patients with lung cancer with suspected left adrenal metastases.

Radiographic assessment of tibial fracture healing continues to pose significant challenges to both routine fracture care and clinical research. Orthopaedic surgeons fail to achieve sufficient agreement on fracture healing when using conventional radiographic measures such as their general impression or the number of cortices bridged by callus. Moreover, the extent to which radiographic assessment of healing corresponds to patient-important outcomes is largely unknown. In an attempt to improve the former (ie, reliability) and inform the latter (ie, validity), recent studies have explored a novel radiographic assessment for tibial shaft fractures, the Radiographic Union Scale for Tibial fractures (RUST). The RUST score assesses the presence of bridging callus and that of a fracture line on each of 4 cortices seen on 2 orthogonal radiographic views. A recent study has found that RUST scores have greater inter-rater reliability when compared with surgeon's general impression or the number of cortices bridged by callus. This may increase the utility of radiographs as a standardized measure of treatment efficacy in the follow-up of tibial fractures.

Background: As the number of studies in the literature is increasing, orthopaedic surgeons highly depend on meta-analyses as their primary source of scientific evidence. The objectives of this review were to assess the scientific quality and number of published meta-analyses on orthopaedics-related topics over time. Methods: We conducted, in duplicate and independently, a systematic review of published meta-analyses in orthopaedics in the years 2005 and 2008 and compared them with a previous systematic review of meta-analyses from 1969 to 1999. A search of electronic databases (MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews) was performed to identify meta-analyses published in 2005 and 2008. We searched bibliographies and contacted content experts to identify additional relevant studies. Two investigators independently assessed the quality of the studies, using the Oxman and Guyatt index, and abstracted relevant data. Results: We included forty-five and forty-four meta-analyses from 2005 and 2008, respectively. While the number of meta-analyses increased fivefold from 1999 to 2008, the mean quality score did not change significantly over time (p = 0.067). In the later years, a significantly lower proportion of meta-analyses had methodological flaws (56% in 2005 and 68% in 2008) compared with meta-analyses published prior to 2000 (88%) (p = 0.006). In 2005 and 2008, respectively, 18% and 30% of the meta-analyses had major to extensive flaws in their methodology. Studies from 2008 with positive conclusions used and described appropriate criteria for the validity assessment less often than did those with negative results. The use of random-effects and fixed-effects models as pooling methods became more popular toward 2008. Conclusions: Although the methodological quality of orthopaedic meta-analyses has increased in the past twenty years, a substantial proportion continues to show major to extensive flaws. As the number of published meta-analyses is increasing, a routine checklist for scientific quality should be used in the peer-review process to ensure methodological standards for publication.

Contains fulltext : 87717.pdf (Publisher’s version ) (Closed access) PURPOSE: In lung cancer patients with multiple lesions, the differentiation between metastases and second primary tumours has significant therapeutic and prognostic implications. The aim of this retrospective study was to investigate the potential of (18)F-FDG PET to discriminate metastatic disease from second primary lung tumours. METHODS: Of 1,396 patients evaluated by the thoracic oncology group between January 2004 and April 2009 at the Radboud University Nijmegen Medical Centre, patients with a synchronous second primary lung cancer were selected. Patients with metastatic disease involving the lungs served as the control group. Maximum standardized uptake values (SUVs) measured with (18)F-FDG PET were determined for two tumours in each patient. The relative difference between the SUVs of these tumours (SUV) was determined and compared between the second primary group and metastatic disease group. Receiver-operating characteristic (ROC) curve analysis was performed to determine the sensitivity and specificity of the SUV for an optimal cut-off value. RESULTS: A total of 37 patients (21 metastatic disease, 16 second primary cancer) were included for analysis. The SUV was significantly higher in patients with second primary cancer than in those with metastatic disease (58 vs 28%, respectively, p < 0.001). The area under the ROC curve was 0.81 and the odds ratio for the optimal cut-off was 18.4. CONCLUSION: SUVs from (18)F-FDG PET images can be helpful in differentiating metastatic disease from second primary tumours in patients with synchronous pulmonary lesions. Further studies are warranted to confirm the consistency of these results. 01 november 2010

Objective To compare the accuracy of estimates of potential recruitment from a prospective 8-week screening study compared with a retrospective chart review across sites participating in two fracture management trials. Study Design and Setting During the planning phase of two large, multicenter, randomized controlled fracture management trials, 74 clinical sites provided estimates of the annual recruitment rate both retrospectively (based on chart reviews) and prospectively. The prospective estimate was generated by screening, for 8 weeks, all incoming patients for eligibility in the concerning trial, without actually enrolling any patient. We compared these prospective and retrospective estimates with one another (for 74 sites in the two trials) and with actual 1-year recruitment rates in the definitive trial (for nine sites in one trial). Results There was a median difference of four patients (interquartile range: −14 to 18 patients; P = 0.89) between a center's prospective estimate and its retrospective estimate. Both predictions were overestimations of recruitment in the definitive trial; only 31% (95% confidence interval [CI]: 28, 35) of retrospectively estimated patients, and 31% (95% CI: 27, 35) of prospectively estimated patients were recruited in the definitive trials. Conclusion Compared with relatively simple chart reviews, prospectively screening for eligible patients at clinical sites, which is associated with substantial costs, did not result in more accurate predictions of accrual in large, multicenter, randomized controlled trials.

A case series is a descriptive study that follows a group of patients who have a similar diagnosis or who are undergoing the same procedure over a certain period of time. As there is no experimental protocol or control for allocation of patients to treatment, surgeons and patients decide on whether or not treatment is given, making the clinical sample representative of a common clinical population. Results of case series can generate hypotheses that are useful in designing further studies, including randomized controlled trials. However, no causal inferences should be made from case series regarding the efficacy of the investigated treatment. This article will provide principles for the design, analysis, and reporting of case series, illustrated by examples from the orthopaedic surgical literature.

We describe 2 patients with pseudoxanthoma elasticum (PXE) and angioid streaks. In one patient PXE was complicated by cardiovascular disease. The other patient presented with acute visual decline in one eye after a minor blunt injury. Information about PXE and its complications is given.

Manual calculus debridement through scaling accounts for a significant proportion of hygienist efforts in dental and periodontal practices. Despite this, little is quantitatively known concerning the effects of instruments, technique and treatments on debridement (scaling) efficiency or efficacy. The total work effort expended by therapists in calculus debridement results from the sum of the efforts associated with each scaling stroke. Each scaling stroke, in turn, is affected by a variety of physical forces, including those in the control of the therapist and those intrinsic to the calculus substrate. The development of procedures and treatments to facilitate easier calculus removal requires consideration of the physical and technique-related factors which contribute to hygienist effort. Instruments have recently been developed which can quantitatively measure force dynamics associated with scaling procedures, including both therapist-applied forces and forces developed due to the extreme hardness and tenacity of supra- and subgingival calculus deposits. The scaling instrument developed to quantitatively record developed forces in scaling, the Quanticalc, can be used for the assessment of techniques and treatments which can soften calculus, facilitating easier debridement. The device can also be used to instruct therapists on factors contributing to surface roughness and tactile response to these factors. The scaling instrument developed to quantitatively measure therapist applied forces in scaling, the Zappa device, can be used for assessment of techniques which can increase the efficiency of calculus removal with minimal damage to sound root substance. In this paper, the force dynamics associated with manual scaling procedures of dental professionals are defined. These force dynamics account for the total work expended by hygienists and other professionals in the important task of calculus removal. Using this as a foundation, the design, use, calibration and clinical applications of these newly developed scaling-force measurement systems are described.

The efficacy of a calculus scaling gel, SofScale (Dentsply, York, PA), has been examined in two protocols by the measurement of scaling forces developed in supragingival calculus debridement from the anterior dentition using hand scaling with a transducer-modified dental scaler, the Quanticalc. In one protocol, the effects of the scaling gel were compared to a placebo gel composed of conventional toothpaste in a double-blind, split-mouth design. In another protocol, the effects of the scaling gel were determined in comparison to non-treated calculus. Results demonstrated that the scaling gel had no apparent effects on the physical forces (work) involved in calculus removal. These results suggest that the application of the scaling gel provides no quantitative benefits in facilitating calculus debridement during manual tooth scaling.

In this paper, a method is described for applying the Quanticalc (QC) dental scaler to the clinical assessment of tartar control dentifrice effects on supragingival calculus formation and therapist efforts required in subsequent calculus debridement. In a 3-month, randomized cross-over study, subjects using Crest Tartar Control were observed to form 25% less calculus than they formed in a similar period using Crest Regular non-tartar control dentifrice as placebo. QC measurements likewise revealed 25% savings in the developed force used to scale the anterior lingual surfaces, coupled with a 27% reduction in the number of strokes required to clean these surfaces free of supragingival calculus in subjects using tartar control dentifrice. The quantitative savings in professional effort amounted to 3 kg (developed forces saved) per subject using tartar control dentifrice. White subjects using placebo dentifrice for 3 months developed less calculus than shown at baseline (29% less calculus), this was not complemented by decreases in total force and strokes used in cleaning. This supports the hypothesis that the surface area coverage of calculus (e.g., the planimetric "area" of supragingival calculus on the tooth) does not contribute alone to the amount of effort as forces and strokes required in subsequent debridement. These results demonstrate that: 1) the QC dental scaler can be effectively used in the clinical assessment of scaling forces/efforts associated with supragingival calculus debridement; and 2) a tartar control dentifrice containing soluble pyrophosphate is clinically effective in reducing both the surface coverage of calculus and the therapist effort required in subsequent calculus debridement.

We have performed retinal fluorescein angiography and audiometry in 32 familial and 7 sporadic cases of facioscapulohumeral muscular dystrophy. A mild to moderate retinal vasculopathy, consisting of retinal teleangiectasis and microaneursyms, was present in 18 of 37 evaluable angiograms (49%); 5 patients had minimal changes and 14 angiograms (38%) were normal. High frequency hearing loss was found in 25 (64%) out of 39 patients. Retinal changes were absent in 5 of 18 families (6 cases examined), and after correction for age and sex, hearing function was normal in 5 of 19 families (7 cases examined). Age and severity of the myopathy did not have a clear relationship with the retinal vasculopathy or the hearing loss. There were no differences between families in which the myopathy was linked to chromosome 4q35 and families in which linkage could not be proven. Minimal retinal vascular changes and high tone hearing loss can be observed occasionally in the normal population. Therefore, although retinal vasculopathy and hearing loss are part of the clinical picture of FSHD, these signs cannot be accepted as decisive criteria for FSHD in clinically equivocal cases.

Nonunions occur in 5-10% of fractures and are characterized by the failure to heal without further intervention. Low intensity pulsed ultrasound therapy has been developed as an alternative to surgery in the treatment of nonunions. We describe a systematic review on trials of low-intensity pulsed ultrasound therapy for healing of nonunions. We searched the electronic databases Medline and the Cochrane library for articles on ultrasound and healing of nonunions published up to 2008. Trials selected for the review met the following criteria: treatment of at least one intervention group with low intensity pulsed ultrasound; inclusion of patients (humans) with one or more nonunions (defined as "established" or as a failure to heal for a minimum of eight months after initial injury); and assessment of healing and time to healing, as determined radiographically. The following data were abstracted from the included studies: sample size, ultrasound treatment characteristics, nonunion location, healing rate, time to fracture healing, fracture age, and demographic information. We found 79 potentially eligible publications, of which 14 met our inclusion criteria. Of these, eight studies were used for data abstraction. Healing rates averaged 87%, (range 65.6%-100%) among eight trials. Mean time to healing was 146.5 days, (range 56-219 days). There is evidence from trials that low-intensity pulsed ultrasound may be an effective treatment for healing of nonunions. More homogeneous and larger controlled series are needed to further investigate its efficacy.

The effect of fluoride, released from a fluoride-containing composite resin, on secondary caries was investigated by quantitative microradiography. In all teeth investigated, less demineralization was found near the composite resin than was found at a distance of a few millimeters from the material after an acid attack. The presence of the fluoride-releasing composite resin reduced the lesion depth measured after an acid attack by about 35%. Therefore, in vivo, a reduction of recurrent caries may be expected around fluoride-containing composite resins.

A new allocation model for teaching and nonteaching staff has been developed at the University of Utrecht. It may be characterized as highly normative, leading to lump sums to be allocated to academic departments. These departments in turn are free—within constraints—to budget their activities differently from the model. The parameters within the model were optimized with regard to a set of centrally determined requirements using a spreadsheet program on a small microcomputer. Details are given regarding the reasons for designing the new model, the design itself, the process of implementation, and the actual use of the model in the framework of the planning process in our institution.

Purified human retinal S-antigen (S-ag) was used to investigate the occurrence of humoral and cellular autoimmune reactions against S-ag in uveitis patients. With a sensitive ELISA method anti-S-ag antibodies could be detected in the sera of 28% of the uveitis patients. No difference was found between patients with posterior or pan-uveitis (31 out of 117 positive) and patients with anterior or intermediate uveitis (16 out of 52 positive). Similar frequencies and levels of anti-S-ag autoantibodies were also found among healthy controls (6/20) and patients who had undergone cataract surgery (6/17). Immunoblotting with purified S-ag and with whole human retinal extract confirmed the presence of anti-S-ag antibodies in uveitis and control sera. Moreover, antibodies against various other retinal proteins could also be demonstrated in patients and controls, without being particularly enhanced in uveitis. The cellular immune responsiveness was tested by measuring the production of migration inhibitory factor (MIF) during overnight culture of peripheral mononuclear cells with the antigen. None of 18 healthy controls responded, whereas 17 positive reactions were observed in the group of 44 uveitis patients. The highest frequencies were found in patients with posterior (5/12) or pan-(7/12) uveitis, while of the responders with anterior (2/8) or intermediate (3/12) uveitis, three had disorders affecting the retina. Thus, cellular autoimmune responsiveness to S-ag is apparently associated with posterior and pan-uveitis, and might also occur in non-uveitic retinal disorders, whereas the occurrence of anti-S-ag antibodies is probably not at all pathognomic for uveitis.

The approximate eigenfunctions of the Morse oscillator are used to obtain by first‐order perturbation treatment the shifts of the transition frequency on intermolecular interactions. The results are shown to converge towards those obtained for the anharmonic oscillator within the limit of low anharmonicity. Subsequently, the obtained expression is used to compute the inhomogeneously broadened vibrational line shape for a number of diatomic molecules in a schematized solvent in the slow modulation limit. The agreement with experiment is fair in view of theoretical shortcomings and experimental errors.

The aim of this study was to quantify the fluoridating effect of a 4% aqueous solution of SnF2 applied for 5 min. and 30 min. resp., and to measure the amounts of KOH soluble fluoride and acquired fluoride separately (APF gel data being included for comparison). Blocks of intact enamel were treated with the topical agents and subsequently exposed to 1 M KOH solutions for 24 h. No significant amount of fluoride was dissolved from control specimens by this treatment. Subsequently, the acquired F in the enamel was determined by the acid etch technique. The amount of fluoride in the KOH solutions after 5 and 30 min. SnF2 application are comparable : 6.2 and 7.4 micrograms . cm(-2) resp. A single topical treatment of SnF2 of 5 and 30 min. did not produce a significant enrichment of fluoride in the enamel. The considerable accumulation of fluoride reaction products on the outer enamel surface was only 1/3 of the amount deposited by APF gels.

A simple correction formula is presented for obtaining true Lorentzian half-band widths from convolutions with triangular slits. The correction is shown to be applicable to a number of other convolutions. Also, the dependence of the depolarization ratio in terms of peak heights on slitwidth is investigated.