Extra-articular manifestations in a community-based sample of patients with rheumatoid arthritis: incidence and relationship to treatment with TNF inhibitors.

OBJECTIVES: To determine the incidence of severe extra-articular rheumatoid arthritis (ExRA) in a community-based cohort of RA patients, and to evaluate whether treatment with tumour necrosis factor (TNF) inhibitors has any effect on the risk of ExRA. METHODS: In a review of clinical records from 1 July 1997 to 31 December 2004, severe ExRA manifestations were classified according to predefined criteria. Patients were censored at the development of ExRA, death, emigration, or 31 December 2004. Exposure to anti-TNF treatment has continuously and independently been recorded as part of a regional follow-up system. RESULTS: During treatment with TNF inhibitors, there were two patients with new onset of ExRA in 408 person-years at risk (pyr) [0.49/100 pyr, 95% confidence interval (CI) 0.06-1.77]. Among those without anti-TNF treatment there were 63 patients with ExRA in 5425 pyr (1.16/100 pyr, 95% CI 0.89-1.49). The relative risk comparing those treated to those not treated with TNF inhibitors was 0.42 (95% CI 0.10-1.73). CONCLUSION: Our data show a lower incidence of ExRA in patients treated with TNF inhibitors but further studies with a larger sample size are needed for a more accurate estimate of the size of the effect.

Students' learning as the focus for shared involvement between universities and clinical practice: a didactic model for postgraduate degree projects.

In an academic programme, completion of a postgraduate degree project could be a significant means of promoting student learning in evidence- and experience-based practice. In specialist nursing education, which through the European Bologna process would be raised to the master's level, there is no tradition of including a postgraduate degree project. The aim was to develop a didactic model for specialist nursing students' postgraduate degree projects within the second cycle of higher education (master's level) and with a specific focus on nurturing shared involvement between universities and healthcare settings. This study embodies a participatory action research and theory-generating design founded on empirically practical try-outs. The 3-year project included five Swedish universities and related healthcare settings. A series of activities was performed and a number of data sources secured. Constant comparative analysis was applied. A didactic model is proposed for postgraduate degree projects in specialist nursing education aimed at nurturing shared involvement between universities and healthcare settings. The focus of the model is student learning in order to prepare the students for participation as specialist nurses in clinical knowledge development. The model is developed for the specialist nursing education, but it is general and could be applicable to various education programmes.

Physiological responses to touch massage in healthy volunteers.

OBJECTIVES: To evaluate effects of touch massage (TM) on stress responses in healthy volunteers. METHODS: A crossover design including twenty-two (mean age=28.2) healthy volunteers (11 male and 11 female) cardiac autonomic tone was measured by heart rate (HR) and heart rate variability (HRV). Stress hormone levels (cortisol) were followed in saliva. We also measured blood glucose and serum insulin. Extracellular (ECV) levels of glucose, lactate, pyruvate and glycerol were followed using the microdialysis technique (MD). TM was performed on hands and feet for 80 min, during control, participants rested in the same setting. Data were collected before, during, and after TM and at rest. Saliva cortisol, serum glucose, and serum insulin were collected before, immediately following, and 1 h after intervention or control, respectively. RESULTS: After 5 min TM, HR decreased significantly, indicating a reduced stress response. Total HRV and all HRV components decreased during intervention. Saliva cortisol and insulin levels decreased significantly after intervention, while serum glucose levels remained stable. A similar, though less prominent, pattern was seen during the control situation. Only minor changes were observed in ECV levels of glucose (a decrease) and lactate (an increase). No significant alterations were observed in glycerol or pyruvate levels throughout the study. There were no significant differences between groups in ECV concentrations of analyzed substances. CONCLUSIONS: In healthy volunteers, TM decreased sympathetic nervous activity, leading to decreased overall autonomic activity where parasympathetic nervous activity also decreased, thereby maintaining the autonomic balance.

Economic evaluation of nursing practices: a review of literature.

BACKGROUND: The importance of cost-effectiveness of nursing practices and its influence on prioritizations has been discussed in literature. It is, however, unclear to what extent health economic analysis has been used in the area of nursing. AIM: The aim of this paper was to investigate how studies of nursing practices apply economic evaluations. METHODS: A literature review was conducted that included studies through August 2007. The search was performed using Medline, CINAHL, PsycINFO, Econlit, DARE, HTA, NHS EED, Cochrane reviews and clinical trials with a search term connected to nursing and health economics. Protocols were used in the screening procedure and the result is reported in a descriptive form. RESULTS: The search identified 115 studies published between 1984 and August 2007. Studies were found in the following nursing practices: provision of support and treatment (n = 17); assessing suffering/well-being (n = 1); preventing or treating ill health (n = 53); and organization of individual care (n = 44). In 22% of all studies, the authors explicitly presented the health economic method used. In 25% of all studies, the perspective of the economic analysis was explicitly stated and a large variability in cost was considered in the analysis. In 82 studies, the authors reported cost-effective intervention. CONCLUSIONS: Although economic evaluation of nursing practice has increased, it is still a rather small area. According to the items elucidated in this study, further methodological improvement is needed to evaluate the economics of nursing.

Stepwise introduction of a bone-conserving osseointegrated hip arthroplasty using RSA and a randomized study: I. Preliminary investigations--52 patients followed for 3 years.

BACKGROUND: We developed a total hip system using osseointegration guidelines, a metaphyseal-loading proximal femoral replacement in the retained neck and a dual-geometry titanium shell in the acetabulum. PATIENTS AND METHODS: A randomized controlled clinical trial was undertaken in 52 patients (53 hips), using the cemented Spectron stem and cementless Harris-Galante II cup as control implants (24 patients in experimental group, 29 control patients). Clinical measures of Harris Hip Score (HHS), pain score and radiostereometric analysis (RSA) at regular intervals for up to three years were used to monitor progress. RESULTS: No statistically significant differences were found in HHS and pain score; the stability of the cementless experimental implant was also comparable to that of the cemented controls by RSA. 3 revisions were required for migration in the experimental group and 1 was required for component dislocation in the control group. INTERPRETATION: Our findings indicate the practicality of osseointegration of titanium implants, but suggest that current performance is inadequate for clinical introduction. However, the stable fixation achieved in the retained neck in the majority of patients is indicative of osseointegration. This finding will encourage technical and design improvements for enhancement of clinical osseointegration and should also encourage further study. Periprosthetic osteolysis might be avoided by the establishment and maintenance of direct implant-bone connection: "osseointegration".

Stepwise introduction of a bone-conserving osseointegrated hip arthroplasty using RSA and a randomized study: II. Clinical proof of concept--40 patients followed for 2 years.

BACKGROUND: We have developed a bone-conserving commercially pure titanium hip replacement system using osseointegration principles: a metaphyseal loading proximal femoral component affixing into the retained neck and metaphysis only, leaving the femoral canal untouched. The acetabular cup closely fits a dual-geometry cavity, avoiding stress protection at the dome. PATIENTS AND METHODS: After extensive laboratory and clinical pilot trial investigations, the surface-engineered implants were submitted to a prospective randomized controlled clinical trial involving 40 patients (40 hips), in which they were compared to the cemented Spectron femoral component and cementless Trilogy cup as control implant. The following clinical measures were used to monitor progress at regular intervals for the first 2 postoperative years: radiostereometric analysis (RSA), Harris Hip Score, pain score, WOMAC, and SF-36. RESULTS: After 2 years of follow-up, no statistically significant differences were seen between the groups concerning rotation or translation along the cardinal axes. The patients receiving the Gothenburg osseointegrated titanium (GOT) system had significantly higher Harris Hip Score at 6 months, suggesting more rapid recovery. WOMAC, SF-36 and pain analysis were similar for the first 2 postoperative years. INTERPRETATION: Our RSA data suggest that osseointegration was achieved for all patients receiving the GOT hip system. This bone-conserving prosthesis may provide a good alternative, especially for young and active patients.

Improved tibial cutting accuracy in knee arthroplasty.

Initial stability and development of long-term fixation for cementless tibial components at the knee both depend on the accuracy of fit between implanted components and prepared bone surfaces. Tibial surfaces prepared for total knee replacement with conventional saw-blades and guides were shown by Toksvig-Larsen to vary by over 2 mm, from a flat surface at the point of maximum variation, and all points varied with a standard deviation of up to 0.4 mm. Surface cutting errors are caused by flexion of the saw-blade and blade angulation from the ideal alignment, due to poor guidance or control by the saw-block or guide. Most conventional knee instrumentation relies on flat surface or slotted cutting blocks, constraining the moving saw-blade against one or two guide surfaces. Improved cutting action was achieved by constraining the saw from the pivot point of the blade, and controlling motion of this constraint with parallel action slides. Using this saw-guide and an improved saw-blade, tibial cuts were made in mock arthroplasty procedures on twenty four cadaveric tibiae in mortuo. Analysis of Variance and Tukey's HSD test showed that the improved saw technique yielded significantly better flatness (p < 0.03) and greatly improved roughness (p < 0.0005).

A novel liner locking mechanism enhances retention stability.

Acetabular liner retention of a novel design of liner locking was evaluated in static and cyclic endurance modes. The locking mechanism combines geometric form and accurate machining to give high conformity to the acetabular shell and minimise relative motion against the metal shell, minimising debris generation and escape or ingress. Using amended test liners with integral coupling, mean static pullout strength was determined to be 399+/-53 N and lever-out strength 28.03+/-2.8 N m. Cyclic loading of 5 N m for up to 10 million cycles caused no significant reduction in strength, no detectable fretting wear, and the sealing mechanism prevented particle access between the cup interior and the "effective joint space". The stability measured ensures secure and reliable in vivo retention of the liner, comparable with extant component designs using other liner locking mechanisms.

Fatigue testing of a proximal femoral hip component.

The Gothenburg Osseointegrated Titanium (GOT) implant is a novel total hip replacement including a metaphyseal loading proximal femoral component fixed in the retained femoral neck. Endurance testing was performed under conditions analogous to ISO 7206-4: 1989. The cement-free implant is not fixed distally within the intramedullary canal, so distal embedding (as specified in the standard) would have been unrealistic. Instead glass-fibre-reinforced epoxy (GFRE) bushings were used to model reduced bone support mid-length at the medial cortex and distally at the lateral cortex. Such support simulated proximal bone loss, realistically reproducing the effect of osteolysis or fixation failure. Under such conditions the component survived unbroken for 10 million cycles at 3.0 kN peak load.

A proximal femoral implant preserves physiological bone deformation: a biomechanical investigation in cadaveric bones.

The aim of this study was to compare the perturbances in bone deformation patterns of the proximal femur due to a conventional cemented femoral stem and a novel uncemented implant designed on the principles of osseointegration. Five matched pairs of fresh frozen human femora were mechanically tested. Bone deformation patterns, measured with a video digitizing system under 1.5 kN joint force, showed that the cemented Spectron femoral implant caused significant alterations to the proximal femoral deformation pattern, whereas the Gothenburg osseointegrated titanium femoral implant did not significantly alter the bone behaviour (p < 0.05). Vertical micromotions measured under 1 kN after 1000 cycles were within the threshold of movement tolerable for bone ingrowth (21 microm for the Gothenburg system and 26 microm for the cemented implant).

Cytotoxic treatment of adrenocortical carcinoma.

Adrenocortical carcinoma (ACC) is a rare, aggressive tumor that is often detected in an advanced stage. Medical treatment with the adrenotoxic drug mitotane has been used for decades, but critical prospective trials on its role in residual disease or as an adjuvant agent after surgical resection are still lacking. The concept of a critical threshold plasma level of the drug must be confirmed in controlled studies. Because individual responsiveness cannot be predicted, the use mitotane is still advised for nonresectable disease. In case of cortisol or other steroid overproduction, several drugs (e.g., ketoconazole or aminoglutethimide) may be used. Chemotherapy with single agents (e.g., doxorubicin or cisplatin) have been disappointing, with low response rates (< 30%) and a short response duration. Part of this refractoriness may be explained by the fact that ACC tumors express the multidrug-resistance gene MDR-1. Chemotherapy with multiple agents has been tested in smaller series and has resulted in significant side effects. The best results were achieved by the combination of etoposide, doxorubicin, and cisplatin associated with mitotane, achieving a response rate of 54%, including individual complete responses. To be able to make progress in treating advanced ACC disease, adjuvant multicenter trials must be encouraged. When mitotane-based therapies are used, monitored drug levels are mandatory.

Development of speech, feeding, eating, and facial expression in Möbius sequence.

OBJECTIVE: Möbius sequence is a rare congenital disorder with the primary diagnostic criteria of congenital facial and abducens nerve palsy. Involvement from other cranial nerves is common. Orofacial anomalies and limb malformations may be associated with the disorder. Mental retardation and autism have been reported in some. The aim of this study was to describe orofacial dysfunction observed in a prospective, multidisciplinary study of individuals with Möbius sequence. METHODS: Twenty-five patients with Möbius sequence, aged 2 months to 54 years, participated in the study. Clinical observations by different medical specialists were collected in an established database. Dentists and a speech pathologist made the orofacial examination. The parents or the patient described orofacial function and dysfunction through interviews and a questionnaire. RESULTS: Bilateral facial palsy was observed in 16 patients, unilateral palsy in 9. Observed orofacial anomalies were tongue dysfunction (16), micrognatia (8), microglossia (7), cleft palate (4), and cleft lip (1). Seventeen had speech problems, 16 reported feeding difficulties in infancy, 14 eating problems, and 8 drooling. CONCLUSIONS: Orofacial problems are common in Möbius sequence and have a significant impact on the quality of life for the patient and for the whole family. Early intervention by a speech pathologist and a paediatric dentist should be undertaken to improve orofacial function and symptoms. Plastic surgery, oral motor training, facial massage, speech therapy, and orthodontic treatment are some of the therapy methods that can be considered.

Evaluation of the QALY model for analysis of cost-effectiveness of eating training after stroke.

New methods developed and insights gained in research are of increasing significance in health care and the question is which services and methods are to be implemented. If eating training after stroke is to be implemented it must be given priority in relation to other measures. Otherwise there is a risk that patients with eating difficulties after stroke will be fed by personnel or permanently receive nourishment via tube. This may lead to expensive measures or costs for the tube feeding as well as costs for the personnel needed for feeding, and patients' well-being will be reduced if they do not have the opportunity to eat as independently as possible. Economic analyses should not guide the priorities to be made, but can be one of several bases for resource allocation. The estimation of cost-effectiveness must, however, be made by means of a method which in its ethical foundation is in line with nursing and the Swedish Government Bill for guiding priorities in health care. The aim of this paper is to discuss the ethical foundation of nursing care and the ethical principles proposed by the Swedish Government Bill for guiding priorities in health care and the model of Quality Adjusted Life Years (QALYs) related to eating training after stroke. The findings showed that there was a considerable difference in the ways health and health maximization were discussed in the QALY model and in specific nursing care. There are two aspects underpinning the QALY model that are not in line with either the ethical foundations of nursing or the principles proposed by the Swedish Government Bill for guiding priorities in health care. However, a new method called Equity Adjusted Life Years (EQALYs) can be a tool for evaluation in specific nursing care. Cost per EQALY is based on a compromise between initial severity of disease and treatment effect that is very close to the distribution rule applied in specific nursing care. In conclusion it is obvious that cost per EQALY, a balance between health maximization and severity of disease and treatment effects, can be a tool for the evaluation of eating training after stroke.

How people with stroke and healthy older people experience the eating process.

The aim of this study was to describe the process of eating, experiences of eating and oral functions. Participants consisted of 30 people with first stroke and localization of the damage verified by computer topography (CT), and 15 healthy older people. All were observed during test-meals, interviewed about eating, and oral functions were tested. The results demonstrated that most (21) people with stroke had some difficulties in eating and expressed feelings of fear and shame about eating and changed physical and social appearance, mainly related to difficulties in preparing and transporting food to the mouth as well as swallowing deficits.

Geriatric-based versus general wards for older acute medical patients: a randomized comparison of outcomes and use of resources.

BACKGROUND: The effects of residence in an acute geriatrics-based ward (AGW) with emphasis on early rehabilitation and discharge planning for older patients with acute medical illnesses were assessed. Outcome and use of resources were compared with those of patients treated in general medical wards (MWs). A per-protocol rather than intention-to-treat analysis was performed. METHODS: A randomized trial with 3-months follow-up. A total of 190 patients aged 70 years and older were randomized to an acute geriatrics-based ward, and 223 patients were randomized to general medical wards. RESULTS: The two groups were comparable at inclusion. However, after care in the AGW, 71% of patients could be discharged directly home compared with 64% of those treated in MWs (relative risk 1.17; 95% CI, 0.93-1.49). The length of stay was shorter in the AGW (mean 5.9 vs 7.3 days; P = .002). The proportion of patients in geriatric or other hospital wards or in nursing homes did not differ, but the proportion of AGW patients in sheltered living tended to be lower (P = .085). At the follow-up, case fatality, ADL function, psychological well-being, need for daily personal assistance, drug consumption, need for readmission to hospital, and total health care costs after discharge did not differ between the two groups. Poor global outcome was observed in 37% of AGW and 34% of MW patients. CONCLUSIONS: A geriatric approach with greater emphasis on early rehabilitation and discharge planning in the AGW shortened the length of hospital stay and may have reduced the need for long-term institutional living. This occurred despite patients in an acute geriatric ward not having better medical or functional outcome than older acute patients treated in general medical wards.

Friction in orthopaedic zirconia taper assemblies.

The torque resistance of zirconia ceramic heads/titanium taper trunnion junctions was tested in accordance with ISO 7206-9:1994(E); using twelve modified heads of 32 mm diameter under representative physiological conditions. Test parameters studied included assembly force, vertical load during test (test load) and head length. Mean torque resistances measured were 8.9 N m for a 1 kN test load and 15 N m at 4 kN test load. Coefficients of friction calculated for the torsional stability ranged from 0.06 to greater than 1.0. Multiple regression analysis confirmed that the failure torques measured were significantly dependent on test load (beta = 0.77; P < 0.001) whereas assembly force and head length played a lesser, insignificant, part in the variation. Data from push-on/pull-off tests were used to calculate coefficients of friction under axial loading, which were significantly correlated with taper angle and material. Torque testing shows greater variability than push-on/pull-off tests for similar combinations, and for zirconia heads on other tapers. The coefficients of friction measured (0.16-0.31) are significantly different from values typically used in stress analyses.

Inaccuracy of acetabular reaming under surgical conditions.

Press-fit uncemented acetabular components require accurate implant-bone cavity fit. Ten cavities produced during actual hip arthroplasty using debris-retaining reamers were replicated in dental alginate. An experimental reamer with better cutting prepared 12 acetabulae in mortuo under similar conditions. Positives in dental stone were measured on a coordinate measuring center. Spheres of best-fit and variation of each point from these spheres were calculated. Control cavities in polyurethane foam were measured to estimate casting errors. Diametral errors of conventionally reamed cavities averaged 2.1%, whereas experimental reamers' cavities varied by 0.5% (P < .005). Overall surface variation from hemispheric form in conventionally reamed cavities exceeded the experimental reamer's results (P < .005). Conventional acetabular reamers cut bone inaccurately. Reamers designed for improved bone cutting reduce cavity errors.

Press-fit acetabular cup fixation: principles and testing.

Pre-clinical testing of the fixation of press-fit acetabular components of total hip prostheses relies on cadaver or synthetic bone, but the properties and geometry of bone models differ from those of physiological bone. Cup designs use varied mechanisms for initial stability in bone; therefore, using different analogues and tests is appropriate. Press-fit cup stability was tested in the following: firstly, polyurethane (PU) foam modelling cancellous support; secondly, glass-fibre reinforced epoxide (GFRE) tubes modelling acetabular cortical support; thirdly, cadaveric acetabula. Three commercial cups [Harris-Galante II (H-G-II), Zimmer; Optifix, Smith & Nephew, Richards; porous coated anatomic (PCA), Howmedica] and an experimental cup with enhanced rim fixation were tested in three modes: direct pull-out, lever-out and axial torque. The fixation stabilities measured in the PU and the GFRE models showed trends consistent with those in cadaver bone, differing in the oversizing and cup geometry. The experimental cup was significantly more secure in most modes than other cups; the H-G II and Optifix cups showed similar stabilities, lower than that of the experimental cup but greater than that of the PCA cup (analysis of variance and Tukey's highly significant test; p < 0.001). The stabilities measured in cadaver bone more closely approximated those in GFRE. The use of several bone analogues enables separation of fixation mechanisms, allowing more accurate prediction of in vivo performance.

First and second branchial arch syndrome: aspects on the embryogenesis, elucidations, and rehabilitation using the osseointegration concept.

BACKGROUND: The osseointegration concept has dramatically changed the possibility of rehabilitating patients with craniofacial defects due to branchial arch syndromes. PURPOSE: This article describes some problems related to the investigative routines and rehabilitation of individuals with malformations of the first and second branchial arches of the craniofacial region. Animal model systems have increased the knowledge of basic embryonic processes that can explain the extent of the malformations. Though most clinical first and second branchial arch syndromes are likely to be caused by sporadic mutations, inherited syndromes occur and also teratogenically induced syndromes are known. Prenatal diagnosis ruling out heredity and exogenous influence seems possible in the future. The possibility of preventing and alleviating fulminant syndromes prenatally also could be conceivable in the future. PATIENTS AND METHODS: The rehabilitation process starts early after birth and should involve a team of specialists including clinical geneticists, pediatricians, audiologists, plastic surgeons, maxillofacial surgeons, otosurgeons, anaplastologists, speech pathologists, pedodontists, and orthodontists. With the development of the osseointegration concept in which craniofacial prostheses and hearing aids can be adapted on implants anchored in the craniofacial skeleton, a new field in the rehabilitation of these malformations has opened. RESULTS: Important aspects in the use of the osseointegration concept include determination of the lowest age for implant surgery, accessibility of adequate bone for implants, the growth of the craniofacial skeleton during childhood, and the possibility for the patient and his or her parents to care for the skin penetration. Adverse tissue reactions, durability of craniofacial prostheses, and the possibility of unknown adverse reactions to metal implants in the body over a long time are other aspects of concern. CONCLUSIONS: Patients with branchial arch syndromes benefit from a well-planned multidisciplinary rehabilitation process in which osseointegrated bone-anchored hearing aids and bone-anchored ear prostheses can be useful tools.

Clinical appearance of spontaneous and induced first and second branchial arch syndromes.

The clinical appearance was investigated of 29 patients with mandibulofacial dysostosis, 26 with hemifacial microsomia, and seven with thalidomide-induced malformations affecting derivatives of the first and second branchial arches. Malformations of the external ear, ear canal, middle ear, zygoma, maxilla, mandible, and lower eye lid were prominent features of the syndromes. Facial nerve and 6th cranial nerve paralysis as well as anophthalmia or microphthalmia were seen only in patients with hemifacial microsomia and in the thalidomide-induced syndrome. We compared the clinical results with those in an animal model in which an induced first and second branchial arch syndrome depends on disturbed migration of neural crest cell during early embryogenesis. The critical time for a similar process in humans would be between the 20th and 29th days of pregnancy.