In vivo genotoxicity assessment of sunset yellow and sodium benzoate in female rats.

The use of additives in different food products is growing up. It has attracted the attention towards the relation between the mutagenic potential of human diseases and food additives. Sunset yellow (SY) and sodium benzoate (NaB) are used as colorant and food additives worldwide. In the present study, genotoxic effects of different combinations of SY and NaB were assessed in vivo in female rats. Different combinations of SY and NaB were dissolved in water and administered daily to six animals groups for 12 weeks. Group 1 (control) received water, Group 2 received 5 mg/kg body weight (bw) SY plus 10 mg/kg bw NaB, group 3 received 5 mg/kg SY plus 100 mg/kg NaB, group 4 received 50 mg SY plus 100 mg/kg NaB, group 5 received 50 mg/kg SY plus 10 mg/kg NaB, group 6 received 200 mg/kg SY plus 750 mg/kg NaB, and group 7 received 20 mg/kg SY plus 75 mg/kg NaB. Genotoxicity investigations (Chromosomal aberration of bone marrow cells, Comet assay and DNA profile of liver cells) were carried out at the end of the experiment. Administration of 200 mg/kg SY plus 750 mg/kg NaB (group 6) induced the highest abnormalities percentage (1.5%) and showed structural abnormalities including end-to-end association, fragmentation, chromatid break, ring chromosome, and centric fusion break of chromosomes. Different combinations of SY and NaB induced an increase in the frequency of tailed nuclei (DNA damage) in liver cells. A concentration-dependent distinct DNA smear pattern was observed in the DNA isolated from liver cells of animals administered SY and NaB. In addition, administration of SY plus NaB resulted in an abnormal distribution of serum proteins. The results showed that the SY plus NaB could have genotoxic potential. With the increase applications of food additives, this study reported important data about screening the potential impacts.

Improving consent in patients undergoing surgery for fractured neck of femur.

Background Neck of femur fractures and their subsequent operative fixation are associated with high rates of perioperative morbidity and mortality. Consenting in this setting is suboptimal with the Montgomery court ruling changing the perspective of consent. This quality improvement project assessed the adequacy of consenting against British Orthopaedic Association-endorsed guidance and implemented a series of changes to improve the documentation of risks associated with surgery for fractured neck of femur. Methods Seventy consecutive patients who underwent any operative fixation of a neck of femur fracture were included over a 6-month period at a single centre. Patients unable to consent or without electronic notes were excluded. Consent forms were analysed and the documented potential risks or complications associated with surgery were compared to British Orthopaedic Association-endorsed guidance. A series of changes (using the plan, do study, act (PDSA) approach) was implemented to improve the adequacy of consent. Results Documentation of four out of 12 potential risks or complications was recorded in <50% of cases for patients with intracapsular fractures (n=35), and documentation of seven out of 12 potential risks or complications was recorded in <50% of cases for patients with extracapsular fractures (n=35). Re-audit following raising awareness and attaching consent guidance showed 100% documentation of potential risks or complications in patients with intracapsular and extracapsular fractures (n=70). A neck of femur fracture-specific consent form has been implemented which will hopefully lead to sustained improvement. Conclusions Consenting patients with fractured neck of femur for surgery in the authors' unit was suboptimal when compared to British Orthopaedic Association-endorsed consent guidance. This project has shown that ensuring such guidance is readily available has improved the adequacy of consent. The authors hope that introduction of a neck of femur fracture-specific consent form within their unit will lead to sustained adequate documentation of risks associated with surgery.