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Setia M.S.,MGM Institute of Health Sciences
Indian Journal of Dermatology | Year: 2017

As researchers, we often collect data on a clinical record form or a questionnaire. It is an important part of study design. If the questionnaire is not well designed, the data collected will not be useful. In this section of the module, we have discussed some practical aspects of designing a questionnaire. It is useful to make a list of all the variables that will be assessed in the study before preparing the questionnaire. The researcher should review all the existing questionnaires. It may be efficient to use an existing standardized questionnaire or scale. Many of these scales are freely available and may be used with an appropriate reference. However, some may be under copyright protection and permissions may be required to use the same questionnaire. While designing their own questionnaire, researchers may use open- or close-ended questions. It is important to design the responses appropriately as the format of responses will influence the analysis. Sometimes, one can collect the same information in multiple ways- continuous or categorical response. Besides these, the researcher can also use visual analog scales or Likert's scale in the questionnaire. Some practical take-home points are: (1) Use specific language while framing the questions; (2) write detailed instructions in the questionnaire; (3) use mutually exclusive response categories; (4) use skip patterns; (5) avoid double-barreled questions; and (6) anchor the time period if required.


Rajan P.,Tata Institute of Social Sciences | Bellare B.,MGM Institute of Health Sciences
Indian Journal of Medical Sciences | Year: 2011

Context: It is now known that resident doctors registered for postgraduate studies are prone to work related stress and eventual burnout. Though stress can happen in any profession, reduced performance of resident doctors due to vocational stress could cause an increase in medical errors and thus affect the quality of life of the patients. Resident doctors at a Municipal hospital in India form a unique population as number of stresses they undergo are many and varied. Aims: To study the prevalence of work-related stress and its anticipated solutions among the resident doctors registered for postgraduate studies in clinical subjects at a tertiary Municipal hospital. Settings and Design: A stratified sampling cross-sectional survey was conducted at the Inpatient, Outpatient, and Intensive Care Units at a tertiary Municipal hospital in Mumbai, India. Material and Methods: Data collection was done using a validated 20-point questionnaire to assess the factors causing stress and their anticipated solutions. Statistical Analysis: Simple percentage analysis of stress questionnaire. Results: 71 resident doctors completed the survey. The major stressors in this cohort were inadequate hostel/quarter facilities (92.1%), and the need to perform extra duties (80.0%). Also, non-conducive environment for clinical training and studies (81.7%), inadequate study (78.9%) and break (81.2%), threat from deadly infections (74.6%), and overburdening with work (69.0%) were the other major stress causing factors. The perceived stress busters were good music (40.8%) and family and friends (40.8%). Eighty-seven percent of the respondents perceived regular physical exercise to be an effective mode of stress management and 83.8% expressed their need to have a simple therapeutic gymnasium established within the campus with a qualified trainer. Conclusions: There is a high level of work related stress among the resident doctors registered for postgraduate clinical studies at a tertiary Municipal hospital in Mumbai. One of the perceived stress busters is regular physical exercise that is structured and under supervision.


Ganguly B.B.,MGM Institute of Health Sciences | Kadam N.N.,MGM Medical College
International Journal of Human Genetics | Year: 2014

A 29 year old woman with history of G2P0+1 and shortening of limbs in past pregnancy referred herself to undergo a fetal anomaly scan at 18th week of gestation. The ultrasonographic imaging of the present pregnancy admeasuring the growth of 12-13 weeks at 18th week detected hydrocephalous condition with short limbs and kyphotic spine. This report aimed at looking for chromosomal aberrations in association with the imaging results and discussed the case in light of available literature. Amniocentesis and conventional cytogenetic analysis was performed following the standard protocol of tissue culture and chromosome banding. Karyotypic analysis of 50 metaphases detected an abnormal female karyotype with 46,XX,inv(9)(p11q13),t(15;16)(q15;q22) pattern. The karyotype revealed two constitutive abnormalities involving four break-points on three different chromosomes in a female genome. Upon counseling, the parents decided to terminate the pregnancy. However, at delivery the external genitalia of the female fetus was found to be of male phenotype and ambiguous. Parental karyotyping revealed transmission of inversion from mother and the balanced translocation from father. Finally the fetal karyotype was expressed as 46,XX,inv(9)(p11q13)mat,t(15;16)(q15;q22)pat. © Kamla-Raj 2014.


PubMed | MGM Institute of Health Sciences and National Health Research Institute
Type: | Journal: Tuberculosis (Edinburgh, Scotland) | Year: 2017

Identification of blood biomarkers that can be useful for predicting Mycobacterium tuberculosis (M.TB) infection, effect of therapy and Multi Drug Resistant (MDR) TB infected individuals is clinically useful for combating tuberculosis epidemic. In this study, we have evaluated the levels of selected miRNAs in serum of TB and MDR TB patients. In addition, we have studied their levels in serum of patients post-therapy. The levels of 4-miRNAs (miR-16, miR-29a, miR-125b and miR-155) were measured in 30 newly diagnosed TB patients, 19 Multi Drug Resistant (MDR) TB patients, 10 patients who completed TB therapy and were TB negative. 30 healthy individuals were recruited as controls. The levels of the miRNAs were estimated by qRT-PCR. Of the four miRNAs studied, the levels of miR-16 were significantly elevated and miR-155 were significantly reduced in serum of TB patients as compared to uninfected controls. The Receiver Operating Characteristic (ROC) curve of miR-16 and miR-155 exhibited a significant distinguishing efficiency with an AUC value of 1 (95% CI, 1 to 1) and 0.967 (95% CI, 0.92-1.04) respectively. Following the therapy, the levels of miR-16 and miR-155 returned to those observed in healthy subjects. In patients with MDR TB, miR-155 was lower as compared to healthy controls and TB treated group but higher as compared to TB nave patients. miR-16 levels were lowest in serum of MDR TB patients compared to TB nave, TB treated group and healthy controls. In conclusion, miR-16 and miR-155 in serum may act as surrogate biomarker for studying TB infection, progression of therapy and MDR TB.


Moksha J.,MGM Institute of Health Sciences | Rebecca J.,MGM Institute of Health Sciences
International Journal of Diabetes in Developing Countries | Year: 2015

WHO has predicted 31.5 million Indians to be affected by type 2 diabetes by the year 2030. Peripheral neuropathy is most common complication of diabetes affecting up to 50–60 % of patients with poor glycaemic control. Hence, evaluation of sensory and pain threshold values in diabetic patients would be useful to investigate underlying diabetic neuropathic process. Convenient sample of 150 diabetics and control group of age and sex-matched 150 healthy individuals were recruited for this descriptive study. Sensory threshold was tested for three peripheral nerves (median, ulnar and radial) of upper limb using Semmes Weinstein monofilament, two point discriminator and electrical stimulator, and pain threshold was recorded using an electrical stimulator. Sensory threshold values of diabetics on monofilament for median, ulnar and radial nerve (3.61, 3.61 and 4.31, respectively) were significantly higher (p < 0.0001) as compared to non-diabetics (2.83, 2.83, 3.61, respectively). Two point discrimination for median (7 mm) and ulnar nerve (7 mm) were significantly higher as compared to non-diabetics (4 mm) (p < 0.0001). Sensory threshold values using an electrical for median, ulnar and radial nerves (22.68 ± 6.61, 20.86 ± 6.37, 24.50 ± 7.53 volts, respectively) were higher as compared to non-diabetics (12.12 ± 2.94, 11.98 ± 3.00, 14.24 ± 3.45 volts) (p < 0.0001). Pain threshold values using an electrical stimulator for median, ulnar and radial nerves (31.6 ± 7.6, 30.3 ± 8, 32.7 ± 8.2 volts, respectively) were also significantly higher (p < 0.0001) as compared to non-diabetics (20 ± 4.9, 19.36 ± 4.7, 22.50 ± 5.3 volts, respectively). Sensory and pain threshold values in diabetics are higher than age- and gender-matched non-diabetics, although they did not present with symptoms, thus indicating possible underlying neuropathy changes. Also, an electrical stimulator can be used as clinical tool to diagnose early neuropathic changes in diabetics. © 2015, Research Society for Study of Diabetes in India.


Setia M.S.,MGM Institute of Health Sciences
Indian Journal of Dermatology | Year: 2016

Cross-sectional study design is a type of observational study design. In a cross-sectional study, the investigator measures the outcome and the exposures in the study participants at the same time. Unlike in case-control studies (participants selected based on the outcome status) or cohort studies (participants selected based on the exposure status), the participants in a cross-sectional study are just selected based on the inclusion and exclusion criteria set for the study. Once the participants have been selected for the study, the investigator follows the study to assess the exposure and the outcomes. Cross-sectional designs are used for population-based surveys and to assess the prevalence of diseases in clinic-based samples. These studies can usually be conducted relatively faster and are inexpensive. They may be conducted either before planning a cohort study or a baseline in a cohort study. These types of designs will give us information about the prevalence of outcomes or exposures; this information will be useful for designing the cohort study. However, since this is a 1-time measurement of exposure and outcome, it is difficult to derive causal relationships from cross-sectional analysis. We can estimate the prevalence of disease in cross-sectional studies. Furthermore, we will also be able to estimate the odds ratios to study the association between exposure and the outcomes in this design. © 2016 Indian Journal of Dermatology | Published by Wolters Kluwer - Medknow.


Setia M.,MGM Institute of Health Sciences
Indian Journal of Dermatology | Year: 2016

Case-Control study design is a type of observational study. In this design, participants are selected for the study based on their outcome status. Thus, some participants have the outcome of interest (referred to as cases), whereas others do not have the outcome of interest (referred to as controls). The investigator then assesses the exposure in both these groups. The investigator should define the cases as specifically as possible. Sometimes, definition of a disease may be based on multiple criteria; thus, all these points should be explicitly stated in case definition. An important aspect of selecting a control is that they should be from the same 'study base' as that of the cases. We can select controls from a variety of groups. Some of them are: General population; relatives or friends; and hospital patients. Matching is often used in case-control control studies to ensure that the cases and controls are similar in certain characteristics, and it is a useful technique to increase the efficiency of the study. Case-Control studies can usually be conducted relatively faster and are inexpensive-particularly when compared with cohort studies (prospective). It is useful to study rare outcomes and outcomes with long latent periods. This design is not very useful to study rare exposures. Furthermore, they may also be prone to certain biases-selection bias and recall bias.


Setia M.,MGM Institute of Health Sciences
Indian Journal of Dermatology | Year: 2016

In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an «open trial.» However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India. © 2016 Indian Journal of Dermatology | Published by Wolters Kluwer - Medknow.


PubMed | MGM Institute of Health Sciences
Type: Journal Article | Journal: Indian journal of dermatology | Year: 2016

Cross-sectional study design is a type of observational study design. In a cross-sectional study, the investigator measures the outcome and the exposures in the study participants at the same time. Unlike in case-control studies (participants selected based on the outcome status) or cohort studies (participants selected based on the exposure status), the participants in a cross-sectional study are just selected based on the inclusion and exclusion criteria set for the study. Once the participants have been selected for the study, the investigator follows the study to assess the exposure and the outcomes. Cross-sectional designs are used for population-based surveys and to assess the prevalence of diseases in clinic-based samples. These studies can usually be conducted relatively faster and are inexpensive. They may be conducted either before planning a cohort study or a baseline in a cohort study. These types of designs will give us information about the prevalence of outcomes or exposures; this information will be useful for designing the cohort study. However, since this is a 1-time measurement of exposure and outcome, it is difficult to derive causal relationships from cross-sectional analysis. We can estimate the prevalence of disease in cross-sectional studies. Furthermore, we will also be able to estimate the odds ratios to study the association between exposure and the outcomes in this design.


Setia M.,MGM Institute of Health Sciences
Indian Journal of Dermatology | Year: 2016

Once the research question and the research design have been finalised, it is important to select the appropriate sample for the study. The method by which the researcher selects the sample is the 'Sampling Method'. There are essentially two types of sampling methods: 1) probability sampling - based on chance events (such as random numbers, flipping a coin etc.); and 2) non-probability sampling - based on researcher's choice, population that accessible & available. Some of the non-probability sampling methods are: purposive sampling, convenience sampling, or quota sampling. Random sampling method (such as simple random sample or stratified random sample) is a form of probability sampling. It is important to understand the different sampling methods used in clinical studies and mention this method clearly in the manuscript. The researcher should not misrepresent the sampling method in the manuscript (such as using the term 'random sample' when the researcher has used convenience sample). The sampling method will depend on the research question. For instance, the researcher may want to understand an issue in greater detail for one particular population rather than worry about the 'generalizability' of these results. In such a scenario, the researcher may want to use 'purposive sampling' for the study. © 2016 Indian Journal of Dermatology | Published by Wolters Kluwer - Medknow.

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