Development of a patient decision aid for discharge planning of hospitalized patients with stroke.

BACKGROUND: Patient involvement in discharge planning of patients with stroke can be accomplished by providing personalized outcome information and promoting shared decision-making. The aim of this study was to develop a patient decision aid (PtDA) for discharge planning of hospitalized patients with stroke. METHODS: A convergent mixed methods design was used, starting with needs assessments among patients with stroke and health care professionals (HCPs). Results of these assessments were used to develop the PtDA with integrated outcome information in several co-creation sessions. Subsequently, acceptability and usability were tested to optimize the PtDA. Development was guided by the International Patient Decision Aids Standards (IPDAS) criteria. RESULTS: In total, 74 patients and 111 HCPs participated in this study. A three-component PtDA was developed, consisting of: 1) a printed consultation sheet to introduce the options for discharge destinations, containing information that can be specified for each individual patient; 2) an online information and deliberation tool to support patient education and clarification of patient values, containing an integrated "patients-like-me" model with outcome information about discharge destinations; 3) a summary sheet to support actual decision-making during consultation, containing the patient's values and preferences concerning discharge planning. In the acceptability test, all qualifying and certifying IPDAS criteria were fulfilled. The usability test showed that patients and HCPs highly appreciated the PtDA with integrated outcome information. CONCLUSIONS: The developed PtDA was found acceptable and usable by patients and HCPs and is currently under investigation in a clinical trial to determine its effectiveness.

Experiences with information provision and preferences for decision making of patients with acute stroke.

OBJECTIVE: The aim of this study was to gain insight into experiences of patients with acute stroke regarding information provision and their preferred involvement in decision-making processes during the initial period of hospitalisation. METHODS: A sequential explanatory design was used in two independent cohorts of patients with stroke, starting with a survey after discharge from hospital (cohort 1) followed by observations and structured interviews during hospitalisation (cohort 2). Quantitative data were analysed descriptively. RESULTS: In total, 72 patients participated in this study (52 in cohort 1 and 20 in cohort 2). During hospitalisation, the majority of the patients were educated about acute stroke and their treatment. Approximately half of the patients preferred to have an active role in the decision-making process, whereas only 21% reported to be actively involved. In cohort 2, 60% of the patients considered themselves capable to carefully consider treatment options. CONCLUSIONS: Active involvement in the acute decision-making process is preferred by approximately half of the patients with acute stroke and most of them consider themselves capable of doing so. However, they experience a limited degree of actual involvement. PRACTICE IMPLICATIONS: Physicians can facilitate patient engagement by explicitly emphasising when a decision has to be made in which the patient's opinion is important.

Higher body mass index is associated with lower foot health in patients with rheumatoid arthritis: baseline results of the Amsterdam-Foot cohort.

Objective: Obesity is highly prevalent in patients with rheumatoid arthritis (RA), with likely impact on weight-bearing foot joints. We explored the associations between body mass index (BMI) and measures of foot health in patients with RA and foot complaints.Method: We examined patients with RA presenting for their first custom-made therapeutic footwear or foot orthoses. Domains of foot health comprised: foot pain, foot-related activity limitations, forefoot plantar pressure, foot synovitis, and foot deformity. In regression analyses, BMI was the independent variable and foot health domains were the dependent variables.Results: The cohort at baseline comprised 230 patients [mean ± sd age 58 ± 13 years, 80% female, mean ± sd disease duration 10 ± 9 years, and median (interquartile range) BMI 26.7 (23.5-30.1) kg/m2]. Small to modest statistically significant associations were found in the majority of the measures studied between a higher BMI and more foot pain, more foot-related activity limitations, higher in-shoe measured forefoot plantar pressure, and the presence of foot synovitis. No relationships were found between BMI and barefoot measured forefoot plantar pressure or foot deformity.Conclusion: BMI is negatively associated with foot health in patients with RA. Although the clinical relevance of our findings for an individual patient is not immediately obvious, future research should consider BMI as a potential therapeutic target to improve foot health.

Forefoot pathology in relation to plantar pressure distribution in patients with rheumatoid arthritis: A cross-sectional study in the Amsterdam Foot cohort.

BACKGROUND: In patients with rheumatoid arthritis (RA), both high and low forefoot plantar pressures have been reported. Better understanding of pathology in the forefoot associated with altered pressure distribution in patients with RA could help to better formulate and specify goals for treatment with foot orthoses or therapeutic footwear. OBJECTIVES: To investigate the association of plantar pressure with disease activity and deformity in the forefoot in patients with rheumatoid arthritis and forefoot symptoms. METHODS: A cross sectional study, using data of 172 patients with rheumatoid arthritis and forefoot symptoms, was conducted. Peak pressure (PP) and pressure time integral (PTI) in the forefoot were measured with a pressure platform. Forefoot deformity was assessed using the Platto score. Forefoot disease activity was defined as swelling and/or pain assessed by palpation of the metatarsophalangeal joints. The forefoot was divided in a medial, central and lateral region, in which the following conditions could be present: 1) no pathology, 2) disease activity, 3) deformity or 4) disease activity and deformity. A multilevel analysis was performed using condition per forefoot region as independent variable and PP or PTI in the corresponding region as dependent variable. RESULTS: Statistically significant higher plantar pressures were found in forefoot regions with deformities (RR 1.2, CI 1.1-1.3, P<0.0001), compared to forefoot regions without forefoot pathology. No significant differences in plantar pressures were found when solely forefoot disease activity was present in forefoot regions. SIGNIFICANCE: Forefoot deformities are related to higher plantar pressures measured in the corresponding forefoot regions. The absence of an association between local disease activity and plantar pressure might be explained by the low prevalence of metatarsophalangeal joint pain or swelling. Future research with sensitive imaging measures to detect disease activity is recommended to reveal the effect of forefoot disease activity on plantar pressure.

Morning administration of 0.4U/kg/day insulin glargine 300U/mL provides less fluctuating 24-hour pharmacodynamics and more even pharmacokinetic profiles compared with insulin degludec 100U/mL in type 1 diabetes.

AIM: To compare steady state pharmacodynamic and pharmacokinetic profiles of insulin glargine 300U/mL (Gla-300) with insulin degludec 100U/mL (Deg-100) in people with type 1 diabetes. METHODS: This single-centre, randomized, double-blind crossover euglycaemic clamp study included two parallel cohorts with fixed once-daily morning dose regimens. For both insulins participants received 0.4 (n=24) or 0.6U/kg/day (n=24), before breakfast, for 8 days prior to the clamp. The main endpoint was within-day variability (fluctuation) of the smoothed glucose infusion rate (GIR) over 24 hours (GIR-smFL0-24). RESULTS: Gla-300 provided 20% less fluctuation of steady state glucose infusion rate profiles than Deg-100 over 24 hours at 0.4U/kg/day (GIR-smFL0-24 treatment ratio 0.80 [90% confidence interval: 0.66 to 0.96], P=0.047), while at the dose of 0.6U/kg/day the difference between insulins was not statistically significant (treatment ratio 0.96 [0.83 to 1.11], P=0.603). Serum insulin concentrations appeared more evenly distributed with both dose levels of Gla-300 versus the same doses of Deg-100, as assessed by relative 6-hour fractions of the area under the curve within 24 hours. Both insulins provided exposure and activity until 30 hours (end of clamp). CONCLUSION: Gla-300 provides less fluctuating steady state pharmacodynamic profiles (i.e. lower within-day variability) and more evenly distributed pharmacokinetic profiles, compared with Deg-100 in a once-daily morning dosing regimen of 0.4U/kg/day.

A Population Dose-Response Model for Inhaled Technosphere Insulin Administered to Healthy Subjects.

Technosphere insulin (TI), an inhaled insulin with a fast onset of action, provides a novel option for the control of prandial glucose. A euglycemic glucose clamp study was performed to compare the effects of TI and regular human insulin (RHI) on the induced glucose infusion rate (GIR) in healthy volunteers. Generation of a dose-response relationship between insulin dose and effect (expressed as AUC of GIR) was not possible from the clinical data directly. The GIR recording time was too short to capture the full effect and higher doses were not tested. Thus, a pharmacokinetic-GIR model was developed to simulate GIR for a sufficient time window of 20 h and for higher doses. A dose-response model was then generated from the simulated GIR profiles. The resulting model provides an ED50 for TI that is 5-fold higher than for RHI, a ratio that can be used as conversion factor for equivalent doses of RHI and TI.

Data-driven directions for effective footwear provision for the high-risk diabetic foot.

AIMS: Custom-made footwear is used to offload the diabetic foot to prevent plantar foot ulcers. This prospective study evaluates the offloading effects of modifying custom-made footwear and aims to provide data-driven directions for the provision of effectively offloading footwear in clinical practice. METHODS: Eighty-five people with diabetic neuropathy and a recently healed plantar foot ulcer, who participated in a clinical trial on footwear effectiveness, had their custom-made footwear evaluated with in-shoe plantar pressure measurements at three-monthly intervals. Footwear was modified when peak pressure was ≥ 200 kPa. The effect of single and combined footwear modifications on in-shoe peak pressure at these high-pressure target locations was assessed. RESULTS: All footwear modifications significantly reduced peak pressure at the target locations compared with pre-modification levels (range -6.7% to -24.0%, P < 0.001). The metatarsal heads were most frequently targeted. Repositioning an existing (trans-)metatarsal pad in the shoe insole (-15.9% peak pressure relief), applying local cushioning to the insole (-15.0%) and replacing the insole top cover with Plastazote (-14.2%) were the most effective single modifications. Combining a new Plastazote top cover with a trans-metatarsal bar (-24.0% peak pressure relief) or with local cushioning (-22.0%) were the most effective combined modifications. CONCLUSIONS: In people with diabetic neuropathy and a recently healed plantar foot ulcer, significant offloading can be achieved at high-risk foot regions by modifying custom-made footwear. These results provide data-driven directions for the design and evaluation of custom-made footwear for high-risk people with diabetes, and essentially mean that each shoe prescribed should incorporate those design features that effectively offload the foot.

Single-dose new insulin glargine 300 U/ml provides prolonged, stable glycaemic control in Japanese and European people with type 1 diabetes.

AIMS: Two single-dose studies were conducted in Japan and Europe to compare the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of new insulin glargine 300 U/ml (Gla-300) and insulin glargine 100 U/ml (Gla-100) in people with type 1 diabetes mellitus. METHODS: In two double-blind, randomized, crossover studies, 18 Japanese participants (aged 20-65 years) and 24 European participants (aged 18-65 years) with glycated haemoglobin levels ≤9.0% (≤75 mmol/mol) received single subcutaneous doses of Gla-300, 0.4, 0.6 and 0.9 U/kg (0.9 U/kg in the European study only), and Gla-100, 0.4 U/kg. A 36-h euglycaemic clamp procedure was performed after each dosing. RESULTS: The serum insulin glargine concentration (INS) and glucose infusion rate (GIR) developed more gradually into more constant and prolonged profiles with Gla-300 than with Gla-100. In support of this, the times to 50% of glargine exposure and insulin activity were longer for all Gla-300 doses than for Gla-100 during the 36-h clamp period, indicating a more evenly distributed exposure and metabolic effect beyond 24 h. Exposure to insulin glargine and glucose utilization were lower with the 0.4 and 0.6 U/ml Gla-300 doses in both studies compared with the 0.4 U/ml Gla-100 dose. Glucose-lowering activity was detected for up to 36 h with all doses of Gla-300. CONCLUSIONS: Single-dose injections of Gla-300 present more constant and prolonged PK and PD profiles compared with Gla-100, maintaining blood glucose control for up to 36 h in euglycaemic clamp settings in Japanese and European participants with type 1 diabetes.

Employment-related concerns of HIV-positive people in the Netherlands: input for a multidisciplinary guideline.

PURPOSE: Finding and keeping employment is difficult for people with HIV. To improve supportive care for people with HIV and employment-related problems, a multidisciplinary guideline was developed in the Netherlands in 2010/2011. To identify the employment-related concerns of people with HIV and to formulate the key questions for the guideline, we conducted a qualitative study. The results of this study are described in this article. METHODS: This study was performed in three HIV-treatment centers in the Netherlands. In total 18 participants participated in three focus-group interviews and nine participants were interviewed individually. The data were transcribed ad verbatim and were analyzed according to the principle of constant comparison. RESULTS: Our findings indicate that people with HIV in the Netherlands face many work-related concerns. The themes which emerged from this study were disclosure, stigma and discrimination, knowledge about HIV, physical and psychological factors, working conditions, absenteeism, reintegration, and dismissal and counselling. CONCLUSIONS: This study provides insight into employment-related concerns for people with HIV living in a Western country. It formed the basis for the key questions which were addressed in a multidisciplinary, evidence-based guideline "HIV and work". Finally, it gives leads for further scientific research and opportunities for improving the vocational guidance of people with HIV.

Investigational new insulin glargine 300 U/ml has the same metabolism as insulin glargine 100 U/ml.

Insulin glargine is processed in vivo into soluble 21(A) -Gly-human insulin (M1), the principal moiety responsible for metabolic effects, and subsequently into M2. This sub-study compared metabolism and metabolite pharmacokinetic (PK) profiles of investigational new insulin glargine U300 (Gla-300) with insulin glargine 100 U/ml (Gla-100, Lantus®, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany) in people with type 1 diabetes. Participants received 0.4 (n = 18) or 0.6 U/kg Gla-300 (n = 12), and 0.4 U/kg Gla-100 (n = 30) once daily in randomized order for 8 days prior to a 36-h euglycaemic clamp. Metabolites were quantified using immunoaffinity enrichment and liquid chromatography tandem mass spectrometry (LC-MS/MS). Glargine metabolism was the same regardless of Gla-100 or Gla-300 administration; M1 was confirmed as the principal active moiety circulating in blood. Steady state concentrations of M1 were achieved after 2 days for Gla-100, and 4 days for Gla-300. Steady state M1 values defined prolonged and even flatter PK profiles after Gla-300 administration compared with M1 profiles after Gla-100.

[Postoperative long-term results in high-grade traumatic ruptures of the spleen in children]. / Postoperative Ergebnisse höhergradiger traumatischer Milzrupturen bei Kindern im Langzeitverlauf.

BACKGROUND: Splenic rupture is the most common injury in blunt abdominal trauma at any age. The grade of rupture, haemodynamic stability and, in the case of operative treatment, the experience of the surgeon all play an important role in preserving the spleen. Due to its important immunological function preservation of the spleen should be the goal. PATIENTS: From January 2000 to August 2009 five children (4 male/1 female) with isolated grade IV or V splenic rupture, according to the Organ Injury Score (OIS), were treated operatively. At the time of the trauma the patients were 8.8 ± 3.8 (mean ± standard deviation; range, 6­15) years old. Four patients with an OIS grade IV rupture were primarily treated with partially spleen-saving surgery: one resection of 2/3 of the spleen including the splenic vessels, one hemisplenectomy and two lower pole resections; in one patient with an OIS grade V rupture splenectomy was performed immediately. RESULTS: In one patient treated with a spleen-preserving approach (hemisplenectomy) the remainder of the spleen had to be removed due to acute bleeding on the first postoperative day. This patient needed two units of blood transfused following the second operation. There were no other complications. The two patients with splenectomy and resection of ⅔ of the spleen developed a transient thrombocytosis indicating impaired clearance of the spleen. In a follow-up involving ultrasonography (median 13, range 1-101 months) all patients managed with partially spleen-saving surgery showed a large remnant spleen with arterial perfusion. CONCLUSION: The majority of primarily partially spleen-preserving operations result from OIS grade IV ruptures of the spleen. Use of a partially spleen-saving surgical approach was successful in ¾ of these patients. Low morbidity and documented perfusion of the remnant spleen at long-term follow-up indicate that a spleen-preserving technique is warranted if an operative approach is required.

[Acute myocarditis complicating Mediterranean spotted fever. A case report]. / Une myocardite aiguë compliquant une fièvre boutonneuse méditerranéenne. À propos d'un cas.

Mediterranean spotted fever (MSF) due to Rickettsia conorii is the most important tick-borne disease occurring in North Africa. The first description of MSF was made by Conor and Brush in 1910 in Tunisia. Clinical diagnosis relies on the association of fever, rash and inoculation's scar during summertime. Prognosis in MSF is usually good, however malignant forms were described. These forms occur in patients with comorbidities. G6PD deficiency is a classic ground for severe forms of MSF. Myocarditis is an uncommon complication in MSF; only few cases were reported in the literature. We report a new case of myocarditis complicating MSF in a 15-year-old patient with G6PD deficiency. The patient presented with fever and rash, evocative of MSF; he reported chest pain and the electrocardiogram showed ST segment elevation in anterior leads. Troponin level was elevated. Echocardiogram showed left ventricular dysfunction with 40% ejection fraction. Serologic tests confirmed R. conorii recent infection. Antibiotic treatment with vibramycine and rifadine was started. Patient also received classic treatment of myocarditis with left ventricular dysfunction associating CEI, ß-bloquers and diuretics. Evolution was favourable with complete recovery of left ventricular function. Myocarditis is an uncommon but severe complication of MSF. Early diagnosis and treatment allow favorable evolution.

Long-term follow-up of a randomized clinical trial comparing Beger with pylorus-preserving Whipple procedure for chronic pancreatitis.

BACKGROUND: Duodenum-preserving pancreatic head resection according to Beger and the pylorus-preserving Whipple (ppWhipple) procedure were compared in patients with chronic pancreatitis (CP) in a randomized clinical trial. Perioperative data and short-term outcome have been reported previously. The present study evaluated long-term follow-up. METHODS: Forty patients were enrolled originally, 20 in each group. Long-term follow-up included mortality, morbidity, pain status, occupational rehabilitation, quality of life (QoL), and endocrine and exocrine function at median follow-up of 7 and 14 years. RESULTS: One patient who had a ppWhipple procedure was lost to follow-up. There were five late deaths in each group. No differences were noted in pain status and exocrine pancreatic function. Loss of appetite was significantly worse in the ppWhipple group at 14 years' follow-up, but there were no other differences in QoL parameters examined. After 14 years, diabetes mellitus was present in seven of 15 patients who had the Beger procedure and 11 of 14 patients after ppWhipple resection (P = 0.128). CONCLUSION: After long-term follow-up of up to 14 years early advantages of the Beger procedure were no longer present.

Deletions of AXIN1, a component of the WNT/wingless pathway, in sporadic medulloblastomas.

Medulloblastoma (MB) represents the most frequent malignant brain tumor in children. Most MBs appear sporadically; however, their incidence is highly elevated in two inherited tumor predisposition syndromes, Gorlin's and Turcot's syndrome. The genetic defects responsible for these diseases have been identified. Whereas Gorlin's syndrome patients carry germ-line mutations in the patched (PTCH) gene, Turcot's syndrome patients with MBs carry germ-line mutations of the adenomatous polyposis coli (APC) gene. The APC gene product is a component of a multiprotein complex controlling beta-catenin degradation. In this complex, Axin plays a major role as scaffold protein. Whereas APC mutations are rare in sporadic MBs, a hot-spot region of beta-catenin (CTNNB1) mutations was identified in a subset of MBs. To find out if Axin is also involved in the pathogenesis of sporadic MBs, we analyzed 86 MBs and 11 MB cell lines for mutations in the AXIN1 gene. Using single-strand conformation polymorphism analysis, screening for large deletions by reverse transcription-PCR, and sequencing analysis, a single somatic point mutation in exon 1 (Pro255Ser) and seven large deletions (12%) of AXIN1 were detected. This indicates that AXIN1 may function as a tumor suppressor gene in MBs.

Therapeutic footwear for the neuropathic foot: an algorithm.

Neuropathy may bring about changes in form and function of the foot, which may lead to ulceration and progressive deformity. These manifestations often require specially adapted footwear. A comprehensive concept of the medical, functional, and technical requirements for this type of footwear is still lacking to date. In this article, We present an algorithm that should facilitate prescription and manufacture of adequate shoes. This algorithm attempts to establish a link between the requirements from a medical and functional point of view and the technical possibilities of orthopedic shoe technology.

Intra-articular triamcinolone acetonide injection in patients with capsulitis of the shoulder: a comparative study of two dose regimens.

BACKGROUND AND PURPOSE: Although corticosteroid injections have been reported to be effective in capsulitis of the shoulder, the optimal dose has not been established. The purpose of this study was to compare relief of symptoms following a lower dose with that following a higher dose of triamcinolone acetonide given intra-articularly. SUBJECTS: Thirty-two patients were given low dose suspension; 25 patients were given high dose suspension. METHOD: Randomized, double-blind clinical trial. Each patient was given a course of three injections. Pain, sleep disturbance, functional impairment and passive range of motion (ROM) were assessed at intake and at one, three and six weeks after the initial injection. Data were analysed by independent sample t-tests and nonparametric Mann-Whitney U-tests. RESULTS: The group which received the 40 mg dose showed significantly greater improvement than the group receiving the 10 mg dose. CONCLUSIONS: The study shows that in the treatment of frozen shoulder greater symptom relief is obtained with a dose of 40 mg triamcinolone acetonide intra-articularly than with a dose of 10 mg. The effect on pain and sleep disturbance was more marked than on ROM. Intra-articular injections with triamcinolone acetonide appear to be an effective method to obtain symptom relief for patients with painful capsulitis of the shoulder.

Energy expenditure during walking in subjects with tibial rotationplasty, above-knee amputation, or hip disarticulation.

The surgical treatment of osteosarcoma with a tibial rotationplasty seems to offer functional advantages in comparison with an above-knee amputation. It has not been established whether the functional advantages are accompanied by a lower rate of energy expenditure during walking. In children with a tibial rotationplasty (n = 15), an above-knee amputation (n = 6), or a hip disarticulation (n = 5), energy expenditure was measured during treadmill walking at various walking velocities. The subjects with a tibial rotationplasty were able to walk faster, but there were no differences between the groups in energy expenditure per unit time or per unit distance. Correction for confounding variables including age, sex, height, time since operation, level of activity, and support during walking in a multiple linear regression model did not reveal any significant differences in energy expenditure during walking between groups. 1992 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation.

Hormonal inducibility of liver-specific enzymes in cultured rat embryos.

In monolayer cultures, hepatocyte-specific enzymes are inducible by hormones as soon as hepatocytes differentiate from the embryonic foregut (15-somite stage). Though offering an excellent opportunity for quantitative studies, several features of a normal cell environment are lost in such a model system. To determine the inducibility of such tissue-specific enzymes in intact organisms, rat embryos were cultured in vitro for 48 h and exposed to the hormonal factors that had been found effective in monolayer culture, viz. dexamethasone, triiodothyronine and dibutyryl cyclic AMP. Normal development of the embryos during culture in vitro was assessed by general criteria reflecting growth, morphogenesis and cytodifferentiation. Development of external features, organogenesis, the distribution of cell divisions and the appearance of tissue-specific proteins such as alpha-fetoprotein and glutamate dehydrogenase served as parameters. Despite undisturbed development of the embryos as judged by these criteria, irrespective of whether the culture was started at day 10 or at day 11 of gestation (just before, respectively after the appearance of the liver primordium), induction of hepatocyte-specific enzymes like carbamoylphosphate synthetase by hormones could not be demonstrated immunohistochemically. However, induction of this enzyme by hormones could be demonstrated in monolayers of hepatocytes isolated from such embryos after 48 h of culture, providing yet another demonstration of the adequate culture conditions. In addition, an adequate uptake of hormones by the embryo during culture could be shown with radio-actively labeled dexamethasone and triiodothyronine and with a radioreceptor assay for cyclic AMP. Therefore, the presence of factors in young embryos that inhibit tissue-specific enzyme synthesis has to be postulated.