Understanding statistical concepts in laboratory quality control measures in biomedical research

The purpose of this article is to explore the quality assurance methods in carrying out laboratory investigations on various kits and biological products and analysing the results through statistical approach. This is commonly used in the health care industry where biological investigations have become a very important part. Quality Control/Quality Assurance (QC/QA) refers to the overall management system which includes the organization, planning, data collection, quality control, documentation, evaluation and reporting activities. With the emerging health issues and availability of modern treatment modalities, it is important to provide the patient, clinical diagnosis with the relevant laboratory investigations. It is therefore, important to maintain the quality control of the testing with a standard degree of precision, which in turn is essential for the delivery of the quality patient care. In view of this, statistical approaches that can be adopted to ascertain the quality of the test have been discussed. The communication also discusses components of validity of the biomedical test and its relevance in clinical settings

Neurodevelopmental disorders in children aged 2-9 years: Population-based burden estimates across five regions in India.

BACKGROUND: Neurodevelopmental disorders (NDDs) compromise the development and attainment of full social and economic potential at individual, family, community, and country levels. Paucity of data on NDDs slows down policy and programmatic action in most developing countries despite perceived high burden. METHODS AND FINDINGS: We assessed 3,964 children (with almost equal number of boys and girls distributed in 2-<6 and 6-9 year age categories) identified from five geographically diverse populations in India using cluster sampling technique (probability proportionate to population size). These were from the North-Central, i.e., Palwal (N = 998; all rural, 16.4% non-Hindu, 25.3% from scheduled caste/tribe [SC-ST] [these are considered underserved communities who are eligible for affirmative action]); North, i.e., Kangra (N = 997; 91.6% rural, 3.7% non-Hindu, 25.3% SC-ST); East, i.e., Dhenkanal (N = 981; 89.8% rural, 1.2% non-Hindu, 38.0% SC-ST); South, i.e., Hyderabad (N = 495; all urban, 25.7% non-Hindu, 27.3% SC-ST) and West, i.e., North Goa (N = 493; 68.0% rural, 11.4% non-Hindu, 18.5% SC-ST). All children were assessed for vision impairment (VI), epilepsy (Epi), neuromotor impairments including cerebral palsy (NMI-CP), hearing impairment (HI), speech and language disorders, autism spectrum disorders (ASDs), and intellectual disability (ID). Furthermore, 6-9-year-old children were also assessed for attention deficit hyperactivity disorder (ADHD) and learning disorders (LDs). We standardized sample characteristics as per Census of India 2011 to arrive at district level and all-sites-pooled estimates. Site-specific prevalence of any of seven NDDs in 2-<6 year olds ranged from 2.9% (95% CI 1.6-5.5) to 18.7% (95% CI 14.7-23.6), and for any of nine NDDs in the 6-9-year-old children, from 6.5% (95% CI 4.6-9.1) to 18.5% (95% CI 15.3-22.3). Two or more NDDs were present in 0.4% (95% CI 0.1-1.7) to 4.3% (95% CI 2.2-8.2) in the younger age category and 0.7% (95% CI 0.2-2.0) to 5.3% (95% CI 3.3-8.2) in the older age category. All-site-pooled estimates for NDDs were 9.2% (95% CI 7.5-11.2) and 13.6% (95% CI 11.3-16.2) in children of 2-<6 and 6-9 year age categories, respectively, without significant difference according to gender, rural/urban residence, or religion; almost one-fifth of these children had more than one NDD. The pooled estimates for prevalence increased by up to three percentage points when these were adjusted for national rates of stunting or low birth weight (LBW). HI, ID, speech and language disorders, Epi, and LDs were the common NDDs across sites. Upon risk modelling, noninstitutional delivery, history of perinatal asphyxia, neonatal illness, postnatal neurological/brain infections, stunting, LBW/prematurity, and older age category (6-9 year) were significantly associated with NDDs. The study sample was underrepresentative of stunting and LBW and had a 15.6% refusal. These factors could be contributing to underestimation of the true NDD burden in our population. CONCLUSIONS: The study identifies NDDs in children aged 2-9 years as a significant public health burden for India. HI was higher than and ASD prevalence comparable to the published global literature. Most risk factors of NDDs were modifiable and amenable to public health interventions

Changing Trends in Use of Laparoscopy: A Clinical Audit

Aim. To find out the changing trends in indications for use of laparoscopy for diagnostic or operative procedures in gynaecology. Methods. This was a clinical audit of 417 women who underwent laparoscopic procedures over a period of 8 years from January 2005 to December 2012 in the Department of Obstetrics and Gynaecology at a tertiary care centre in Delhi. Results. A total of 417 diagnostic and operative laparoscopic procedures were performed during the period from January 2005 to December 2012. Out of 417 women, 13 women were excluded from the study due to inadequate data. 208 (51.4%) women had only diagnostic laparoscopy whereas 196 (48.6%) patients had operative laparoscopy after the initial diagnostic procedure. Change in trend of diagnostic versus operative procedures was observed from 2005 to 2012. There was increase in operative procedures from 10 (37.03%) women in 2005 as compared to 51 (73.91%) in 2012. The main indication for laparoscopy was infertility throughout the study period (61.38%), followed by chronic pelvic pain (CPP) (11.38%) and abnormal uterine bleeding (AUB) (9.4%). Conclusion. Over the years, there has been a rise in the rate of operative laparoscopy. Though the indications for laparoscopy have remained almost similar during the years, laparoscopy for diagnosis and treatment of CPP and AUB has now increased

Clinical Study Changing Trends in Use of Laparoscopy: A Clinical Audit

Aim. To find out the changing trends in indications for use of laparoscopy for diagnostic or operative procedures in gynaecology. Methods. This was a clinical audit of 417 women who underwent laparoscopic procedures over a period of 8 years from January 2005 to December 2012 in the Department of Obstetrics and Gynaecology at a tertiary care centre in Delhi. Results. A total of 417 diagnostic and operative laparoscopic procedures were performed during the period from January 2005 to December 2012. Out of 417 women, 13 women were excluded from the study due to inadequate data. 208 (51.4%) women had only diagnostic laparoscopy whereas 196 (48.6%) patients had operative laparoscopy after the initial diagnostic procedure. Change in trend of diagnostic versus operative procedures was observed from 2005 to 2012. There was increase in operative procedures from 10 (37.03%) women in 2005 as compared to 51 (73.91%) in 2012. The main indication for laparoscopy was infertility throughout the study period (61.38%), followed by chronic pelvic pain (CPP) (11.38%) and abnormal uterine bleeding (AUB) (9.4%). Conclusion. Over the years, there has been a rise in the rate of operative laparoscopy. Though the indications for laparoscopy have remained almost similar during the years, laparoscopy for diagnosis and treatment of CPP and AUB has now increased