Kanica Kaushal

Risk approach strategy in diabetics on fasting-evidence base through narrative review with a special focus on Ramadan fasting

The past two decades have seen a rise in the number of investigations examining the health-related effects of religiously motivated fasts. The fact that fasting is a common religious practice observed not only among Muslims, but among many other religious communities as well underlie a long felt need for drafting recommendations on fasting in diabetic patients as there are no substantial guidelines for the same. An extensive review of the work involving studies across populations in India and other nations across the world was conducted, with the aim to arrive at some broad consensus highlighting on the need for developing strict guidelines for patients with diabetes during fasting, before fasting and afterwards.

Calculating incidence and prognosis in a prospective study

Sir, This is in reference to the article, “Acute kidney injury (AKI)-incidence, prognostic factors, and outcome of patients in an Intensive Care Unit in a tertiary center: A prospective observational study.”[1] The authors have done a commendable job to find the incidence, prognostic factors, and outcome of patients with AKI. However, I have a few concerns regarding the type of study and methodology being adopted in the present study. First, the authors have written in their material and methods that the study done was a prospective, observational, and cross-sectional study conducted in the hospital. The epidemiologic studies are either descriptive or analytical studies. Descriptive studies include case reports, case series reports, cross-sectional studies, surveillance studies, and ecological studies, whereas analytical studies are either experimental or observational. A prospective study is a type of observational study.[2] Hence, how can a study be “cross-sectional, that is descriptive” and “prospective” at the same time? The aim of this study is to analyze the incidence, prognostic factors, and 28 days outcome of AKI. Hence, this is a “prospective cohort” study. The cross-sectional study tells about the characteristics of a population at one point in time (like a photo “snapshot”) and is used to estimate the prevalence (not incidence) of a health condition or prevalence of a behavior, risk factor, or potential for disease.[2] Further, the authors have provided the incidence of AKI in critically ill patients during the study period of 6 months as 16.1% (as a percentage), whereas incidence being a rate, should have been quoted just as 16.1/1000 Intensive Care Unit admissions and not as a percentage. Incidence rate refers during a given time period in a specified population at risk. The measure most often used is person years and not percentage.[3] Finally, prognosis can be expressed either in term of deaths from the disease or in terms of survivors with the disease. In describing survival after diagnosis of AKI, it must have been more useful to present incidence data in a plot of cumulative incidence over time, taking into account loss to follow-up, using a Kaplan-Meier plot.[4] Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.

Knowledge about the ill effects of tobacco use and “Cigarettes and other tobacco products (Prohibition of advertisement and regulation of trade and commerce, production, supply and distribution) Act.” among adult male population of Shimla City

Background: Cigarettes and other tobacco products act 2003 (COTPA) is the principal law governing tobacco control in India. However, enforcement of the provisions under the law is still a matter of concern. The desired impact and level of enforcement of the COTPA legislation and the gutka and pan masala ban in Himachal Pradesh need assessment. Objective: The objective of this study was to assess the knowledge and attitudes about the ill effects of tobacco use and COTPA among the adult male population of Shimla City. Materials and Methods: This study was a cross-sectional community-based survey carried out in Boileauganj, Shimla. Data were collected using a structured schedule by interviewing 100 participants. Proportions, percentages were calculated, and the Fischers exact test was applied for the categorical variables. Results: About 58% had heard of ban on smoking in public places and 53% knew that Himachal Pradesh has been declared as a no smoke state. Only 50% of the participants had heard of COTPA. Conclusion: These dismal findings suggest average knowledge levels of male adults about COTPA, which calls for a sensitization workshop and advocacy for all the stakeholders.

Observational studies versus controlled clinical trials for efficacy & effectiveness of a drug

Sir, This is regarding an article on effect of clobazam (CLB) as add-on antiepileptic drug in patients with epilepsy published recently1. The authors have done a commendable job to evaluate usage pattern, retention rate, effectiveness and tolerability of clobazam during routine practice in an outpatient epilepsy clinic of a tertiary care hospital in north India. They have conducted an observational study by taking consecutive sample of consenting PWE (patients with epilepsy) attending the OPD. Patients of all age and either gender taking CLB were included in the evaluation in the present study1. We have a few concerns regarding the methodology adopted in this study. It would have been more appropriate to conduct an observational study with a nested case-control group to evaluate the efficacy of clobazam. The authors could have taken the patients on clobazam as the case group and those who were on some other antiepileptic drug except clobazam as controls. Further, the cases and controls should have been matched for age and gender. Except in specific circumstances, the aim of observational post-authorisation efficacy studies is not to demonstrate the efficacy of a drug; this is the role of randomized clinical trials (RCTs). Once efficacy has been demonstrated, observational studies are useful to study effect modifiers, namely variables that may influence the level of efficacy of the drug and have been controlled for in the RCTs2. To assess strengths and weaknesses of different design options to study efficacy in the conditions of the everyday medical practice, recommendations have been issued for the improvement of methods2. Further, the aim of the study was to evaluate effectiveness of clobazam during routine practice in an outpatient epilepsy clinic. Efficacy and effectiveness exist on a continuum and RCTs are considered the gold standard in evaluating the effects of treatments. Controlled clinical trials can be efficacy trials (explanatory trials) which determine whether an intervention produces the expected result under ideal circumstances and effectiveness trials (pragmatic trials) which measure the degree of beneficial effect under “real world” clinical settings3. A nested case-control study would have helped to determine if an exposure is associated with an outcome (i.e. disease or condition of interest), for example, as given by the authors in the results; viz. seizure free period in patients, improvement in seizure control, change in disease severity without change in seizure frequency and the causes for discontinuation of CBZ. The authors could have given the results in comparison with the control group by calculating the frequency of each of the measured variables in the two groups and as a measure of the strength of the association between an exposure and the outcome, the odds ratio should have been calculated.

Matching for risk factors in case control studies

Sir, Apropos of article on genetic and environment factors in the aetiology of colorectal cancer in Malaysia1, the authors need to be complimented. As mentioned in the abstract under the sub-heading “Methods” this was a case control study. A total of 160 Malaysian subjects were recruited, including both colorectal cancer cases (CRC) and controls. The inclusion criteria for controls were: Malaysians aged more than 18 yr who had never been diagnosed with any cancer and did not have a family history of any cancers. However, I have a few concerns regarding the methodology adopted by the authors. The authors have taken into account (by way of exclusion) diagnosis of any malignancy and chronic illnesses before or after recruitment and they have matched controls to cases based on their gender, age, ethnicity and smoking status. The outcome of this study would have been useful for programme implementers and clinicians if other factors influencing the outcome were incorporated in the study. This could have been achieved by matching the following factors among cases or controls or accounting for them post-hoc at the time of analysis: For example, a large body of evidence indicates that several dietary and lifestyle factors are likely to have a major influence on the risk of colorectal cancer. Consumption of processed or red meat, especially when cooked at high temperatures is associated with increased risk of colorectal cancer2. Diets high in lipids, especially animal fat increase the risk of colorectal cancer. Also the pooled relative risk of colorectal cancers for the obese versus normal categories of BMI (body mass index) was 1.351 for studies conducted in Asia3. Further, the risk of individuals with diabetes to develop colorectal cancer is 1.22 times higher than that of individuals without diabetes4. Modifiable non dietary factors like cigarette smoking has been matched for in the present study but the authors have not considered alcohol use for the same. Alcohol consumption is significantly associated with increased risk of colon cancer5. All these risk factors should have been matched by taking the dietary history, personal history (for heavy drinkers), medical history (for diabetes) and anthropometric measurements to calculate BMI (to rule out obesity). Matching would have ensured that the controls were similar to the cases with regard to variables that could confound the outcome of the study.

Community health orientation of Indian Journal of Endocrinology and Metabolism: A bibliometric analysis of Indian Journal of Endocrinology and Metabolism.

Background: Endocrine and metabolic diseases especially diabetes have become focus areas for public health professionals. Indian Journal of Endocrinology and Metabolism (IJEM), a publication of Endocrine Society of India, is a peer-reviewed online journal, which covers technical and clinical studies related to health, ethical and social issues in field of diabetes, endocrinology and metabolism. This bibliometric analysis assesses the journal from a community health perspective. Materials and Methods: Every article published in IJEM over a period of 4 years (2011–2014) was accessed to review coverage of community health in the field of endocrinology. Results: Seven editorials, 30 review articles, 41 original articles, 12 brief communications, 20 letter to editors, 4 articles on guidelines and 2 in the section “endocrinology and gender” directly or indirectly dealt with community health aspects of endocrinology. Together these amounted to 17% of all articles published through these 4 years. There were 14 articles on general, 60 pertaining to pancreas and diabetes, 10 on thyroid, 7 on pituitary/adrenal/gonads, 21 on obesity and metabolism and 4 on parathyroid and bone; all community medicine related. Conclusion: Community health is an integral part of the modern endocrinology diabetology and metabolism practice and it received adequate journal space during the last 4 years. The coverage is broad based involving all the major endocrine disorders.

Assessment of attitude in KAP study: A comment on: A survey on doctors' knowledge and attitude of treating chronic pain in three tertiary hospitals in Nigeria

level of consultants. Those who had special training on pain management will have further edge on answering the knowledge questions and will be better in practising the chronic pain management. Hence, clubbing such variegated participants together for arriving at mean scores does not seem justifiable.

Letter to Editor: Interpreting Incidence from Hospital Based Data Retrieval: A Comment on Incidence and Determinants of Stillbirth amongst Parturients in Two Hospitals in Southern Nigeria

Background: Fetal death is a major but often overlooked public health issue. Aim: Knowledge of the causes and risk factors will help in designing measures to reduce the burden of fetal death in Nigeria. Materials and Methods: A 5 year descriptive study of all fetal mortality of >28 weeks in Southern Nigeria. Relevant details were extracted from the case notes and the registers in the labor ward, maternity ward, the labor ward theater and the main theater. Statistical Analysis Used: The data was analyzed using Statistical Package for Social Scientist (SPSS PC+) and this consisted of univariate analysis and comparisons of identified relationships. Results: The total number of deliveries from 28 weeks was 25,780 and the number of parturients with fetal mortality after 28 weeks was 157 and therefore the incidence of stillbirth was 0.6% giving a mortality rate of 6.1/1000 total births. However, 148 (85%) case notes of the total fetal deaths were retrieved and formed the study sample. Socio-demographic variables such as extremes of age and parity, unbooked status, unemployment, unmarried, Isoko, Itsekiri and Ijaw ethnic groups and primary level or no formal education were determinants of stillbirth. Others were maternal diabetes mellitus, malaria, hypertension, labor duration >4 h, instrumental or assisted vaginal delivery, gestational age at booking >12 weeks, low birth weight and preterm births. Conclusion: The fetal mortality (stillbirth) rate was low and the determinants were identified. Public health education, female education and socio-economic empowerment are suggested preventive measures.

Prospective cohort versus retrospective cohort studies to estimate incidence

Sir, This is in reference to the article, “Abdominal compartment syndrome (ACS): Incidence and prognostic factors influencing survival in Singapore”.[1] The authors have conducted this study to calculate the incidence of ACS by doing a retrospective review of the morbidity and mortality reports in their general surgery department database to identify the cases (Material and Methods).[1] I have a few concerns regarding the methodology adopted by the authors in the present study. Reviewing hospital based records is unable to provide us with the incidence. Incidence primarily being a rate needs two comparison time units wherein a specified population is followed through and hospital data retrieved from records is unable to provide that.[2] Incidence actually is a measure of probability of developing a particular condition during a specified period for the individuals in the population observation,[3] and is calculated as the number of new cases occurring in a defined population during a specified period of time.[4] This point is further clarified once we have a look at the results. The authors have provided the incidence of ACS of all Intensive Care Unit admissions during the study period of 10 years as 0.1% (as a percentage), whereas incidence being a rate, should have been quoted just as 0.1 per 1000 Intensive Care Unit admissions and not as percentage. As per the definition of incidence given above, the incidence rate refers during a given time period in a specified population at risk. The measure most often used is person years and not percentage.[3] Further, retrospective studies usually have more potential sources of bias and confounding than prospective studies. Retrospective cohort studies like this are very efficient because they take much less time and cost much less than prospective cohort studies but sometimes exposure status is not clear when it is necessary to go back in time and use whatever data was available, because the data being used was not designed to be used in a study.[5] Lastly, prognosis can be expressed either in term of deaths from the disease or in terms of survivors with the disease. In describing survival after diagnosis of ACS, it must have been more useful to present incidence data in a plot of cumulative incidence over time, taking into account loss to follow-up, using a Kaplan-Meier Plot.