Insect-pathogen crosstalk and the cellular-molecular mechanisms of insect immunity: uncovering the underlying signaling pathways and immune regulatory function of non-coding RNAs.

Multicellular organisms are constantly subjected to pathogens that might be harmful. Although insects lack an adaptive immune system, they possess highly effective anti-infective mechanisms. Bacterial phagocytosis and parasite encapsulation are some forms of cellular responses. Insects often defend themselves against infections through a humoral response. This phenomenon includes the secretion of antimicrobial peptides into the hemolymph. Specific receptors for detecting infection are required for the recognition of foreign pathogens such as the proteins that recognize glucans and peptidoglycans, together referred to as PGRPs and ßGRPs. Activation of these receptors leads to the stimulation of signaling pathways which further activates the genes encoding for antimicrobial peptides. Some instances of such pathways are the JAK-STAT, Imd, and Toll. The host immune response that frequently accompanies infections has, however, been circumvented by diseases, which may have assisted insects evolve their own complicated immune systems. The role of ncRNAs in insect immunology has been discussed in several notable studies and reviews. This paper examines the most recent research on the immune regulatory function of ncRNAs during insect-pathogen crosstalk, including insect- and pathogen-encoded miRNAs and lncRNAs, and provides an overview of the important insect signaling pathways and effector mechanisms activated by diverse pathogen invaders.

Role of Sialendoscopy in Non-neoplastic Parotid Diseases: A Prospective Study of 241 Patients in Indian Population.

Objectives: To assess the role of sialendoscopy as a diagnostic modality and in managing cases of non-neoplastic parotid gland diseases. Secondly, to provide descriptive analysis of intraoperative findings. Methods: The patients of chronic parotid sialadenitis who presented with complaints of recurrent unilateral or bilateral parotid swelling and pain were included in the study. All patients underwent sialendoscopy, and the findings were noted. Intervention was carried out in the same sitting like dilatation of stenosis, stone removal by basket, combined approach, flushing of mucoid flakes, etc. Failed cases were worked up with radiological investigation and managed accordingly. Results: Two hundred and forty-one cases of parotid sialadenitis who underwent sialendoscopy between 2012 and 2018 were included. Diagnostic sialendoscopy was achieved in 100% cases, while intervention was successful in 96.7% (233/241) cases after the first procedure. On diagnostic sialendoscopy, ductal stenosis was the most common pathology present in 177 (73.4%) patients followed by stones (12%) and debris (11.6%). All cases of stenosis were serially dilated with increasing sizes of sialendoscopes followed by stenting in 75% of the cases. The diagnosis of juvenile recurrent parotitis was confirmed in 17 children (mean age 5.6 years) with consistent clinical history and sialendoscopic findings of stenosis along with pale ductal mucosa. There were 18 cases where ductal perforation was seen. One case showed multiple hyperdense foci in bilateral parotid gland along with multiple strictures that underwent repeat sialendoscopy, but the symptoms did not resolve, and finally the patient underwent bilateral superficial parotidectomy. Conclusion: Sialendoscopy is a safe and highly effective modality in managing non-neoplastic parotid gland disorders with low complication rates and resulted in gland preservation in the vast majority of patients. Therefore, it can be concluded that sialendoscopy is the diagnostic and therapeutic modality of choice for parotid obstructive sialadenitis.

Coronin-1 levels in patients with tuberculosis.

Background & objectives: Despite advances in diagnostics and therapeutics, tuberculosis (TB) is widely prevalent and contributes to a significant burden of illness in both developing and developed nations. The present study was aimed to assess the role of coronin in TB patients and healthy controls. Coronin is a leucocyte-specific protein that is actively recruited in mycobacterial phagolysosomes, where it inhibits lysosomal delivery of Mycobacterium by activating a calcium-dependent phosphatase-calcineurin. Methods: In the study, 100 newly diagnosed cases of TB (pulmonary and extra-pulmonary) and healthy controls were prospectively enrolled over one year and the levels of coronin-1a in these patients and controls were measured by quantitative PCR (qPCR). Results: A total of 100 TB patients and 100 healthy individuals as controls were assessed. There were 59 patients with extra-pulmonary TB (EPTB) and 41 of pulmonary TB (PTB). In 47 per cent of patients, corroborative histopathological evidence of TB was also available. Significantly higher values of coronin-1a were observed in TB patients (19.94±2.61) than in healthy controls (16.09±1.91) (P<0.001). Interpretation & conclusions: Coronin 1a appears to play an important role in the TB disease pathophysiology and agents developed against coronin may have a role in the treatment of TB. Further studies are required to assess if coronin-1a levels are elevated in non-tubercular infective a etiologies and whether these can be a potential drug target in patients with TB.

Combined Endoscopic-Transcutaneous Approach for Management of Large Parotid Stones.

INTRODUCTION: The aim of this paper is to present our experience with combined endoscopic-transcutaneous approach in terms of effectiveness and safety in patients with large or impacted parotid stones. MATERIALS AND METHODS: This is a prospective study carried out from August, 2012 to February, 2017 analyzing 21 patients with parotid sialolithiasis. The indication of combined approach was either failed attempt to remove the stone endoscopically, large size (>4mm), or impacted stone. The exact location of the stone was pointed out by endoscopic transillumination and the stone was removed via transcutaneous incision which could be linear incision or a preauricular incision followed by stenting for 3 weeks. RESULTS: We were successfully able to remove the stone in all 21 cases using modified Blair's incision in 18 cases, while a linear incision was used in remaining 3 cases. Two patients developed stricture in the post-operative period at 5 and 3 months, respectively. The strictures were successfully dilated endoscopically and the patients are asymptomatic ever since. CONCLUSION: Combined endoscopic-transcutaneous approach is a highly successful approach with few complications for removal of parotid stones and thus resulting in high gland preservation rates in patients of parotid sialolithiasis.

Our Experience with Intraoral Submandibular Gland Excision.

The aim of this paper is to present our experience with intraoral approach for submandibular gland excision in terms of effectiveness and safety in patients with chronic sialadenitis. This is a prospective study carried out from November, 2016 to April, 2018 analyzing 13 patients of chronic sialadenitis. The indication of intraoral approach was either failed attempt to remove the stone endoscopically, chronic sialadenitis or benign tumor. The surgical triangle was used as the landmark for hilar area and gland was dissected close to the capsule and removed via intraoral incision and preserving the sublingual gland. We were successfully able to remove the submandibular gland via intraoral approach in 10 cases. Two patients had to undergo transcervical gland excision and one patient refused for transcervical approach. Intraoral excision of submandibular gland is a safe and viable approach to be utilized in carefully selected patients. The major advantages being avoidance of transcervical scar and of injury to marginal mandibular branch of facial nerve.

Research ethics committees in a tight spot: Approving consent strategies for child research that are prima facie illegal but are ethical in terms of national guidelines.

It is an internationally accepted principle that ethics norms should be applied and enforced in research with humans through ethics review by research ethics committees (RECs). This places RECs at the very heart of the system for protecting participants and enforcing their rights. In the South African ethical-legal framework for child research, there are divergent approaches to consent. That is, section 71 of the National Health Act (No. 61 of 2003) (NHA) requires mandatory parental consent for child research, and limits the authority for proxy consent to parents and legal guardians. However, national ethics guidelines authorised by section 72 of the NHA and issued by the National Health Research Ethics Council (NHREC) acting in terms of its mandate (National Department of Health, 2015) allow a more nuanced approach - i.e. self-consent by older adolescents, provided certain conditions are met, and consent by a range of parental substitutes where there are no available parents or legal guardians. We have argued elsewhere that the consent approach in section 71 is inappropriately restrictive and are of the view that the consent approach endorsed in national ethics guidelines is more defensible. An REC that elects to approve a consent strategy allowable in ethics guidelines is effectively electing to not follow section 71, which raises the question of what the consequences might be for that REC. This article examines the legal liability of RECs through three 'threads' of accountability: the NHREC, the institutions hosting RECs, and the courts. We conclude that: (i) if an REC approves a child protocol with consent strategies allowable in terms of national ethics guidelinesbut not in terms of section 71, it is unlikely that the NHREC would discipline the REC in the face of a complaint - provided the REC acted within national ethics guidelines issued by the NHREC in terms of the latter's section 72 mandate to set national norms and standards; (ii) if an REC approves a consent approach allowed for in ethics guidance, it is also unlikely that the host institution would discipline the REC in the face of a complaint - especially if the institution is aware of the REC's explicit decision to follow national ethics guidelines that are authorised by section 72 of the NHA; and (iii) an REC could only be sued by a participant in terms of the law of delict (and be liable for damages) if several demanding components are proven, such as that the harm suffered by the participant resulted directly from the REC's actions in approving a particular consent strategy for that research. Furthermore, the court may well look to national ethics guidelines in making determinations about whether an REC's conduct was wrongful for the purposes of liability in civil law. RECs are protected from being collectively liable by insurance taken out by their host institutions. We make a series of recommendations to address this issue.

Obtaining informed consent for a sterilisation in the light of recent case law.

The need to obtain informed consent prior to any sterilisation is a very well-established ethical and legal obligation. South African law, however, does not specifically state who is responsible for obtaining informed consent before performing a sterilisation. This has implications for the liability of a surgeon or gynaecologist in circumstances where the informed consent is defective. Due to the vagueness of the applicable law, a surgeon or gynaecologist might be held liable, even in situations where he/she did not obtain the consent and relied on a nurse or assistant to procure the relevant informed consent. This article explores the relevant statutory law and canvasses two legal cases that came before the court regarding defective informed consent and the resultant liability for damages. We also make recommendations for proposed amendments to the current law to provide further clarity.

Sialendoscopic Approach in Management of Juvenile Recurrent Parotitis.

To assess the role of sialendoscopy as a diagnostic and therapeutic modality in juvenile recurrent parotitis. Juvenile recurrent parotitis (JRP) is the second most frequent salivary gland disease in childhood and is characterized by recurrent non suppurative and non obstructive parotid inflammation. These attacks influence the quality of life and can even lead to gland destruction, and there are no definitive treatment to avoid them. Sialendoscopic dilatation is emerging as the new treatment modality in this aspect. STUDY DESIGN:  retrospective study. STUDY SETTING: Department of Otorhinolaryngology in tertiary care hospital. 17 cases of juvenile recurrent parotitis (i.e. children of age group 3-11 years presenting with complaints of recurrent parotid region swelling and pain, sometimes associated with fever) were included in the study during October 2012-September 2015. All cases underwent sialendoscopy under general anaesthesia. Diagnostic (classifying the ductal lesion) and interventional sialendoscopic procedure (dilatation with instillation of steroid) were carried out in single sitting. Follow up was done for a minimum of 6 months (range 6-36 months). 17 patients with mean age of 5.6 years and gender distribution of 47:53 (boys:girls) underwent sialendoscopy for JRP. 8 patients presented with unilateral parotitis and 9 with bilateral. The mean number of attacks in previous 1 year were 9.2. Average time for procedure was 20 min. All cases had ductal stenosis and ductal mucosa was pale in 15 cases on endoscopy. 1 patient underwent repeat endoscopy after 2 years. 50% had complete resolution of symptoms and 6 patients had one mild (swelling not associated with fever which subsided on its own) attack after treatment. Follow up period ranged from 6 months to 3 years. No complications were observed. Sialendoscopy has emerged as a viable option for assessment and treatment of JRP. Dilatation of the parotid duct and steroid instillation has significantly reduced the morbidity of this condition.

How safe is the use of chlorpyrifos: Revelations through its effect on layer birds.

AIM: The present study was aimed to investigate the immunological competence of chlorpyrifos (CPF) insecticide after oral administration in layer chickens. MATERIALS AND METHODS: A total of 20 White Leghorn birds were given CPF in drinking water at 0.3 ppm/bird/day (no observable effect level dose) for a period of 3-month. Immune competence status of layer birds and chicks hatched from CPF-treated birds were estimated at 15 days interval in layer birds and monthly interval in chicks using immunological and biochemical parameters. RESULTS: There was a significant decrease in values of total leukocytes count, absolute lymphocyte count, absolute heterophil count, total serum protein, serum albumin, serum globulin, and serum gamma globulin in the birds treated with CPF as compared to control. Similarly, immune competence tests such as lymphocyte stimulation test, oxidative burst assay, and enzyme-linked immunosorbent assay tests indicated lower immunity in birds treated with CPF as compared to control. Subsequently, chicks produced from CPF-treated birds were also examined for immune competence, but no significant difference was observed between chicks of both the groups. CONCLUSION: The exposure to CPF produced hemo-biochemical and other changes that could be correlated with changes in the immunological profile of layer chickens suggesting total stoppage of using CPF in poultry sheds.

Effect of endosulfan on immunological competence of layer birds.

AIM: The present study was aimed to investigate the immunological competence of endosulfan insecticide after limited oral administration in White Leghorn layer chickens. MATERIALS AND METHODS: A total of 20 White Leghorn birds were given endosulfan in drinking water at 30 ppm/bird/day (no observable effect level dose) for a period of 3-months. Immune competence status of layer birds and chicks hatched from endosulfan offered birds were estimated at 15-day interval in layer birds and at monthly interval in chicks using immunological, biochemical parameters, and teratological estimates. RESULTS: There was a significant decrease in levels of total leukocytes count, absolute lymphocyte count, absolute heterophil count, total serum protein, serum albumin, serum globulin, and serum gamma globulin in the birds fed with endosulfan as compared to control. Similarly, immune competence tests such as lymphocyte stimulation test, oxidative burst assay, and enzyme-linked immunosorbent assay tests indicated lower immunity in birds treated with endosulfan as compared to control. Subsequently, chicks produced from endosulfan-treated birds were also examined for immune competence, but no significant difference was observed between chicks of both the groups. CONCLUSION: The exposure to endosulfan in limited oral dosage was able to exhibit hemo-biochemical and other changes that could be correlated with changes in the immunological profile of layer chickens suggesting cautious usage of endosulfan insecticide in poultry sheds.

Will Septal Correction Surgery for Deviated Nasal Septum Improve the Sense of Smell? A Prospective Study.

Background and Objectives. Nasal obstruction due to deviated nasal septum is a common problem bringing a patient to an otorhinolaryngologist. Occasionally, these patients may also complain of olfactory impairment. We proposed to study the effect of septal deviation on the lateralised olfactory function and the change in olfaction after surgery of the septum (septoplasty). Methods. Forty-one patients with deviated nasal septum were evaluated for nasal airflow, olfactory score, and nasal symptomatology. Septoplasty was done under local anesthesia. Pre- and postoperative olfactory scores, airflow and olfactory scores, and nasal symptomatology and olfactory scores were compared and correlated. Results. The range of preoperative composite olfactory score (COS) on the side of septal deviation was 4-14 (mean 7.90 ± 2.234) and on the nonobstructed side was 9-18 (mean 14.49 ± 2.378). Severity of deviated nasal septum and preoperative COS of diseased side were correlated and the correlation was found to be significant (rho = -0.690, p = 0.000 (<0.001)). The preoperative mean COS (7.90 ± 2.234) was compared with the postoperative mean COS (12.39 ± 3.687) and the improvement was found to be statistically significant (p = 0.000 (<0.001)). Conclusion. We found improvement in olfactory function in 70.6% patients after surgery, no change in 20.1%, and reduced function in 7.6%. With the limitation of a small sample size and a potential repeat testing bias, we would conclude that correction of nasal septal deviation may lead to improvement in sense of smell.

Socio-economic & household risk factors of malaria in tribal areas of Madhya Pradesh, central India.

BACKGROUND & OBJECTIVES: Malaria is a major public health problem in many States of the country, particularly, in Madhya Pradesh where both Plasmodium vivax and P. falciparum are endemic. Although many studies have been conducted to investigate risk factors for malaria, but only a few have examined household and socio-economic risk factors. The present study was, therefore, undertaken to explore the relationship of different socio-demographic, socio-economic and behavioural risk factors with malaria prevalence in tribal areas of Madhya Pradesh, India. METHODS: This study was undertaken in all 62 villages of Bargi Primary Health Centre from May 2005 to June 2008. These villages comprised 7117 households with an average family size of five members. Fortnightly fever surveys were conducted in all villages to assess prevalence of malaria infection in the community. The distinct univariate and multivariate logistic regression models were fitted on the data set. RESULTS: The important socio-demographic risk factors like age of household head, social group, occupation and family size; socio-economic factors like type of walls of house, place of drinking water source, irrigated land, cash crop; and behavioural variables like place of sleeping, use of bed nets, etc. were found significantly associated with malaria in univariate analyses. In multivariate analyses only social groups, family size, type of walls of house, and place of sleeping had strong significant association with prevalence of malaria. INTERPRETATION & CONCLUSIONS: The study shows that in tribal areas where people are living in poor quality of houses with no proper use of preventive measures, malaria is firmly established. We conclude that community based interventions which bring improvement in standard of living, access to healthcare facilities and health awareness, will have a significant impact on malaria prevention in these areas.

Low free to total PSA ratio is not a good discriminator of chronic prostatitis and prostate cancer: An Indian experience.

Aims: To find out the utility of free to total PSA ratio in discriminating chronic prostatitis and prostate cancer. Setting and design: The patients visited urology clinics at Batra Hospital and Medical Research Center, New Delhi. Background: The use of serum free to total PSA as a diagnostic tool for prostate cancer has led to early detection of prostate cancer; however, the effect of inflammation on f/t PSA ratio restricts its use in early detection of cancer. Materials and Methods: The study was conducted in age related 101 patients which include 27 carcinoma patients (group I), 34 BPH patients (group II) and 40 chronic prostatitis patients (group III). Serum total PSA (tPSA) and free PSA (fPSA) were analyzed on Elecsys 2010. These were compared with histological reports of biopsy specimen. Other biochemistry tests were done on Randox Imola. P Value was calculated using one way ANOVA with posthoc Bonferroni analysis. Results: Serum total PSA levels were comparable in group I and III and were higher than group II (P < 0.049). Serum fPSA in group I was not significantly different from group II and III, However, group II has higher levels than group III (P < 0.035). Difference was significant for f/t PSA ratio in group I and II (P < 0.00) and group II and III (P < 0.000).Group I and III were with comparable levels (P < 0.807). Conclusions: f/t PSA ratio is not a good discriminator for malignancy and chronic prostatitis. This limitation of f/t PSA ratio must be taken into consideration while interpreting the results clinically.

Status of oxidative stress and antioxidant levels in smokers with breast cancer from western Nepal.

BACKGROUND: Research indicates that oxidative stress induced by smoking plays a role in breast cancer. In view of these reports, we aimed to study th relationship between smoking and oxidative stress in breast cancer patients from the western region of Nepal. MATERIALS AND METHODS: The study included a control group of 42 females (non-smoking healthy women) and a test group sudivided into Group I consisting of 46 female breast cancer patients who were smokers and Group II consisting of 42 non-smoking breast cancer patients. Detailed history of the patients was collected with the help of pre-test proforma. Plasma levels of malondialdehyde (MDA), total antioxidant activity (TAA) which represents total dietary antioxidants, vitamin C and α- tocopherol were estimated by standard methods. Statistical analysis was done using SPSS version 16. RESULTS: The plasma MDA, TAA, vitamin C and α- tocopherol were 1±1.4nmol/ml, 918±207µmol/L, 1±0.24mg/dL and 0.94±0.31mg/dL in controls, 5±1.2nmol/ml, 458±166 µmol/L, 0.64±0.32mg/dL and 0.5±0.3mg/dL in Group-I and 2.56±1.2nmol/ml, 663±178 µmol/L, 0.78±0.2mg/dL and 0.77±0.2mg/dL in Group- II, respectively. Vitamin C, α- tocopherol and TAA (p=0.001) were significantly reduced whereas MDA (p=0.001) was significantly raised in Group-I when compared to controls and Group-II. CONCLUSIONS: We observed a significant rise in oxidative stress and low levels of antioxidants in breast cancer patients with smoking habit. It is well known that free radicals facilitate the progression of breast cancer, possibly increasing the risk of progression to the next stage.

Assessment of knowledge of harmful effects and exposure to recreational music in college students of delhi: a cross sectional exploratory study.

Exposure to loud sounds results in a mild to profound degree of temporary or permanent hearing loss. Though occupational noise exposure remains the most commonly identified cause of noise-induced hearing loss, potentially hazardous noise can be encountered during recreational activities. Unfortunately not much attention is being given to the increasing trend of prolonged exposure to noisy environment, in the younger generation of Indians. The purpose of our study was to know the knowledge of college students about the harmful effects of loud music, prevailing practices with regard to exposure to recreational music and the subjective effects that this exposure is causing if any. Cross Sectional survey of College Students (n = 940), from randomly selected colleges of Delhi University. Majority of students listened to music using music-enabled phones; earphones were preferred and 56.6 % participants listened to music on a loud volume. Effects experienced due to loud sound were headache (58 %), inability to concentrate (48 %), and ringing sensation in the ear (41.8 %). Only 2.7 % respondents used ear protection device in loud volume settings. Twenty-three percent respondents complained of transient decreased hearing and other effects after exposure to loud music. 83.8 % knew that loud sound has harmful effect on hearing but still only 2.7 % used protection device. The survey indicates that we need to generate more such epidemiological data and follow up studies on the high risk group; so as to be able to convincingly sensitize the Indian young generation to take care of their hearing and the policy makers to have more information and education campaigns for this preventable cause of deafness.

Quantification of clonal circulating plasma cells in newly diagnosed multiple myeloma: implications for redefining high-risk myeloma.

The presence of clonal circulating plasma cells (cPCs) is a marker of high-risk disease in all stages of monoclonal gammopathies. However, the prognostic utility of quantitating cPCs using multiparametric flow cytometry in multiple myeloma (MM) patients with current treatments is unknown. There were 157 consecutive patients with newly diagnosed MM seen at the Mayo Clinic, Rochester from 2009 to 2011 that had their peripheral blood evaluated for cPCs by multiparameter flow cytometry. Survival analysis was performed by the Kaplan-Meier method and differences assessed using the log-rank test. Using a receiver operating characteristics (ROC) analysis, ⩾400 cPCs were considered as the optimal cutoff for defining high-risk disease. The presence of ⩾400 cPCs was associated with higher plasma cell (PC) proliferation and adverse cytogenetics. The median time-to-next-treatment and overall survival (OS) in patients with ⩾400 cPCs (N=37, 24%) was 14 months and 32 months compared with 26 months and not reached for the rest (P<0.001). In a multivariable model, the presence of ⩾400 cPCs and older age adversely affected OS. Flow cytometry to quantify cPCs is a valuable test for risk stratifying newly diagnosed MM patients in the era of novel agents. Future studies are needed to determine its role in developing a risk-adapted treatment approach.

Association between preoperative glucocorticoids and long-term survival and cancer recurrence after colectomy: follow-up analysis of a previous randomized controlled trial.

BACKGROUND: The effect of anaesthetic drugs on long-term oncological outcomes after cancer surgery is an area of current interest. Dexamethasone is widely used in anaesthetic practice; however, its effect on long-term survival and cancer outcomes is not known. This study presents the results of a 5-yr follow-up of patients receiving dexamethasone before elective colectomy as part of a previous randomized clinical trial. METHODS: Sixty patients who underwent elective open colonic resection for any indication between June 2006 and March 2008 were randomized to receive either 8 mg i.v. dexamethasone or placebo before surgery. A 5-yr follow-up analysis was conducted to evaluate overall survival, disease-free survival and recurrence specifically for patients undergoing resection for Stage I-III colon cancer. Kaplan-Meier analysis was performed and log-rank test was used to evaluate difference in survival between groups. RESULTS: Forty-three of the 60 subjects had Stage I-III colon cancer and were included in the follow-up analysis. Twenty received preoperative dexamethasone and 23 received placebo. There were no significant differences between groups in baseline or disease characteristics. No differences were found between groups for overall or disease-free survival. In the dexamethasone group, there was a significantly higher rate of distant recurrence (6 compared with 1, P=0.04). CONCLUSIONS: Preoperative dexamethasone was associated with a higher rate of distant recurrence in patients undergoing colectomy for colon cancer. Given the small sample size, this finding should be interpreted with caution, but warrants further investigation in a prospective study.

Systematic review and meta-analysis of use of serum C-reactive protein levels to predict anastomotic leak after colorectal surgery.

BACKGROUND: Several recent studies have investigated the role of C-reactive protein (CRP) as an early marker of anastomotic leakage following colorectal surgery. The aim of this systematic review and meta-analysis was to evaluate the predictive value of CRP in this setting. METHODS: A systematic literature search was performed using MEDLINE, Embase and PubMed to identify studies evaluating the diagnostic accuracy of postoperative CRP for anastomotic leakage following colorectal surgery. A meta-analysis was carried out using a random-effects model and pooled predictive parameters were determined along with a CRP cut-off value at each postoperative day (POD). RESULTS: Seven studies, with a total of 2483 patients, were included. The pooled prevalence of leakage was 9·6 per cent and the median day on which leakage was diagnosed ranged from POD 6 to 9. The serum CRP level on POD 3, 4 and 5 had comparable diagnostic accuracy for the development of an anastomotic leak with a pooled area under the curve of 0·81 (95 per cent confidence interval 0·75 to 0·86), 0·80 (0·74 to 0·86) and 0·80 (0·73 to 0·87) respectively. The derived CRP cut-off values were 172 mg/l on POD 3, 124 mg/l on POD 4 and 144 mg/l on POD 5; these corresponded to a negative predictive value of 97 per cent and a negative likelihood ratio of 0·26-0·33. All three time points had a low positive predictive value for leakage, ranging between 21 and 23 per cent. CONCLUSION: CRP is a useful negative predictive test for the development of anastomotic leakage following colorectal surgery.

Compensation for research-related harm: the implications of Venter v Roche Products (Pty) Limited and Others for research ethics committees.

BACKGROUND: The issue of what type of compensation a research participant would be entitled to in a clinical trial when they have signed an informed consent document excluding certain forms of compensation recently came before our courts in the matter of Venter v Roche Products (Pty) Limited and Others (Case No. 12285/08). In this case, the court had to consider whether the plaintiff, Mr Venter, was entitled to claim for non-medical costs such as pain and suffering, loss of income and general damages, even though the informed-consent document expressly excluded such claims. OBJECTIVES: To set out the facts, issues and judgment in the case, concluding with a discussion of the implications of the judgment for research ethics committees (RECs). METHODS: Critical review of a judgment of the Western Cape High Court. RESULTS: The court concluded that Mr Venter's application for damages should be dismissed because he had voluntarily agreed to the limited compensation as set out in the informed consent form that had been approved by both the local RECs and the Medicines Control Council. CONCLUSIONS: The Venter case has shown that delictual claims for research-related injuries will not be successful if plaintiffs have agreed to limit their own rights through signing an informed-consent form that limits compensation. This places an important obligation on RECs to ensure that they carefully review compensation clauses in informed-consent documents and that these are made clear to potential research participants.