Informed consent: how much and what do patients understand?

Objective

We sought to evaluate the degree of patients' understanding of several aspects of the informed consent process for surgery and clinical research.

Methods

We conducted a systematic search of PubMed (1961-2006) to identify relevant articles.

Results

We retrieved 23 and 30 eligible for inclusion articles regarding informed consent for surgery and clinical research, respectively. Regarding surgery, adequate overall understanding of the information provided and of the risks associated with surgery was shown in 6 of 21 (29%) and 5 of 14 (36%) studies providing relevant data, respectively. Regarding clinical research, adequate understanding of the aim of the study, the process of randomization, voluntarism, withdrawal, and the risks and the benefits of treatment was shown in 14 of 26 (54%), 4 of 8 (50%), 7 of 15 (47%), 7 of 16 (44%), 8 of 16 (50%), and 4 of 7 (57%) of studies providing relevant data, respectively. Satisfaction by the amount of the given information was shown in 7 of 12 (58%) studies involving surgery and 12 of 15 (80%) studies involving clinical research.

Conclusions

Further attention should be drawn on enhancing patients' understanding regarding several components of the informed consent process for surgery and clinical research.     

Refractory psychosis and prominent cognitive deficits in a patient with mega-cisterna magna

We present a case of refractory psychosis with prominent cognitive deficits in a patient with 'mega-cisterna magna', a congenital defect within the 'Dandy-Walker Complex' continuum. The 21-year-old female had a 3-year history of refractory psychotic symptoms despite adequate antipsychotic treatment. CT and MRI scans disclosed 'mega-cisterna magna'. Thorough neuropsychological testing recorded extensive deficits. Treatment with amisulpride 1200 mg/day resulted in a 30% decrease in PANSS score within 2 months. Then galantamine 8 mg/day was added and PANSS score decreased further by 27% within 2 weeks. Cognitive and social functioning was overall much improved. The effect was sustained in a 24 months follow-up. It is postulated that even a less extended cerebellar lesion, such as mega-cisterna magna, can be associated with psychosis, and in some cases with treatment refractoriness or cognitive dysfunction. Adjuvant galantamine may improve cognitive and psychosocial functioning in these patients.     

Metabolic profiling in disease diagnosis, toxicology and personalized healthcare

Metabolic profiling employs a combination of sophisticated analytical tools to obtain global "untargeted" metabolic profiles from tissues, cells or biofluids. The resulting complex multivariate data are then modeled statistically to reveal differences between classes (e.g. dosed vs. control) and identify discriminatory metabolites. Metabolic profiling has a wide range of applications, encompassing nutrition, disease diagnosis, epidemiology and toxicology, providing insights into altered biological pathways and offering fresh mechanistic perspectives. Further, the untargeted nature of metabolic profiling can allow for new biomarkers of disease or toxic effect to be uncovered. In this review, key metabolic profiling technologies will be introduced and data analysis approaches described briefly. The role of metabolic profiling in disease diagnosis, toxicology and personalized healthcare will be discussed.     

Normalisation of total body iron load with very intensive combined chelation reverses cardiac and endocrine complications of thalassaemia major

Cardiac and endocrine disorders are common sequelae of iron overload in transfused thalassaemia patients. Combined chelation with desferrioxamine (DFO) and deferiprone (DFP) is well tolerated and produces an additive/synergistic effect superior to either drug alone. 52 thalassaemia major patients were transitioned from DFO to combined chelation with DFO and DFP. Serum ferritin, cardiac and hepatic iron levels were monitored regularly for up to 7 years, as were cardiac and endocrine function. Patients’ iron load normalized, as judged by ferritin and cardiac and hepatic magnetic resonance imaging findings. In all 12 patients receiving treatment for cardiac dysfunction, symptoms reversed following combined chelation, enabling nine patients to discontinue heart medications. In the 39 patients with abnormal glucose metabolism, 44% normalized. In 18 requiring thyroxine supplementation for hypothyroidism, 10 were able to discontinue, and four reduced their thyroxine dose. In 14 hypogonadal males on testosterone therapy, seven stopped treatment. Of the 19 females, who were hypogonadal on DFO monotherapy, six were able to conceive. Moreover, no patients developed de novo cardiac or endocrine complications. These results suggest that intensive combined chelation normalized patients’ iron load and thereby prevented and reversed cardiac and multiple endocrine complications associated with transfusion iron overload.     

Green tea,white tea,and Pelargonium purpureum increase the antioxidant capacity of plasma and some organs in mice

ObjectiveWe tested in mice the hypothesis that ingestion of infusions of green tea, white tea, or the aromatic plant Pelargonium purpureum increases total antioxidant capacity (TAC) of plasma and organs.MethodsTwenty-five mice were randomly assigned to five groups, each of which received by gavage 0.1 mL of infusion from green tea, white tea, or P. purpureum (8 g/100 mL of water) or catechin (0.01 g/100 mL) or water for 5 consecutive days. On the fifth day the animals were euthanized. Blood was taken by heart puncture and the heart, lungs, liver, spleen, kidney, and brain were removed. TAC was measured in plasma and in all organ homogenates with the ferric reducing antioxidant power assay and in selected organ homogenates by the total radical-trapping antioxidant parameter assay.ResultsGreen tea and P. purpureum increased TAC in the plasma and lungs, whereas green tea, white tea, and catechin increased TAC in heart homogenates. No effect was observed on the liver, brain, spleen, and kidney homogenates in comparison with the water control with the ferric reducing antioxidant power assay or the total radical-trapping antioxidant parameter assay.ConclusionThese results suggest that green tea, white tea, and P. purpureum exhibit antioxidant effects in vivo that may be observed not only in plasma but also in some organs.     

Total and free PSA kinetics in patients without prostate cancer undergoing radical cystoprostatectomy

BACKGROUND: Radical cystoprostatectomy and radical prostatectomy are the two major operations where prostate is totally and radically removed. Radical cystoprostatectomy is usually performed in patients with invasive bladder cancer. The aim of the study was to examine Total PSA, Free PSA, and Free/Total Ratio elimination kinetics after radical cystoprostatectomy. METHODS: Serum PSA, Free PSA, and Free/Total Ratio were determined preoperatively, at the time of cystoprostatectomy specimen removal and then at 3, 6, 12, 24, 48, 72, and 168 hr, from seven patients with muscle invasive bladder cancer, who underwent radical cystoprostatectomy. Free and Total PSA concentrations were measured with non-competitive immunological procedures. The elimination rates and half-lives of Total, Free PSA and Free/Total Ratio were studied using a nonlinear regression analysis. RESULTS: Surgical manipulations caused about 1.5-fold increase of PSA, 5-fold increase in Free PSA and 3-fold increase in Free/Total Ratio. PSA and Free PSA followed a biphasic elimination pattern of a rapid exponential (a) phase with a half-life of 4.27 and 2.14 hr and a terminal, nonexponential (b) phase with a half-life of 63 and 173.2 hr, respectively. Free/Total PSA Ratio followed, also, a biphasic kinetic pattern of a rapid exponential decline with a half-life of 3.34 and a terminal non-exponential increase with a doubling time of 43 hr. CONCLUSIONS: Comparing PSA kinetics after radical cystoprostatectomy with those of radical prostatectomy, it appears that PSA follows the same elimination pattern in both models. In contrast, Free PSA and Free/Total Ratio elimination kinetics' patterns differ between the two surgical models.     

Treatment of experimental osteomyelitis by methicillin resistant Staphylococcus aureus with bone cement system releasing grepafloxacin

The authors examined the effectiveness of the local anti-microbial treatment on methicillin resistant Staphylococcus aureus (MRSA) experimental osteomyelitis. Thirty-six rabbits with chronic MRSA osteomyelitis of the right femur were treated with local grepafloxacin delivery system prepared by a mixture of acrylic bone cement (polymethyl methacrylate, PMMA) plus 4% grepafloxacin. Osteomyelitis was induced by inoculating MRSA (100 μl of cultured bacteria; 10⁷) and the local insertion of a needle, serving as a foreign body, at the upper third of the femur. The course of the infection was followed by clinical, radiographic and microbiological examination. In the third week, all animals were re-operated, needles were removed, and antibiotic containing acrylic cement was implanted. Thereafter, one control and five treated animals were sacrificed per week, within 6 weeks. Osteomyelitis was found in all rabbits. In vitro grepafloxacin levels remained high throughout the 6 weeks of the experiment. Histologically tissue reaction against the cement was not observed. Osteomyelitis lesions and bone structure were progressively repaired after cement implantation. Biomechanical analysis showed no significant influence on the mechanical properties of acrylic cement due to grepafloxacin. The above mixture could prove to be an important supplementary method for the treatment of bone infections. Such a system could replace the use of gentamycin PMMA beads in the treatment of patients with chronic osteomyelitis due to MRSA. Furthermore, the proposed method could be used as a spacer after removal septic loosened prostheses in combination with systemic administration of antibiotics.