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Background: Even though quantitative studies have described barriers to anti-retroviral therapy (ART), a more exploratory approach will provide in-depth information on these issues, and potential suggestions to address these issues at individual as well as structural level. We designed this qualitative study to examine the barriers and facilitators for antiretroviral therapy adherence in key population (KP) in Mumbai, India. We also wanted to understand the strategies adopted by these groups and get suggestions to improve adherence to ART. Methods: This is a qualitative analysis of seven focus group discussions (FGDs) conducted with four KP subgroups in Mumbai. We conducted two FGDs each with female sex workers (FSW), men who have sex with men (MSM), male-to-female transgendered people/Hijras (TGH) each, and one FGD with people who inject drugs (IDU). We transcribed the audio-recorded electronic records of these FGDs. We also added the notes of the observers on the group dynamics to the transcribed data. We used the Framework Approach to analyse these data. Results: Some experiences–such as side effects to ART medicines–were common across groups. However, incarceration as a reason for stopping ART was reported by FSWs but not by other KPs. Friends and family (including Guru) are important support systems for HIV infected individuals and adherence to ART. Stigma and discrimination by community members and general community prevent regular access of ART centres and other health care facilities. Additional factors which led to missed doses were mental health issues, alcohol use, and misplacing the ART tablets during police raids or during robbery attempts at the cruising sites. Since a common source of discrimination among peers and the community was the presence of 'Green book' (or their treatment book); the key population wanted the AIDS program to change it to digital cards so that labelling one as 'HIV positive' for being seen with the book can be avoided. Conclusions: The qualitative study helped us explore the barriers to ART among key population and the community provided specific suggestions to address them. In addition to Key Population centric enhanced adherence counselling, some administrative guidelines and procedures may need to be altered to improve adherence to ART in these populations. [ABSTRACT FROM AUTHOR]

Introduction: Hesitancy towards COVID-19 vaccines may be a major hindrance to a successful vaccination program. We assessed the vaccine uptake, facilitators, and barriers for the COVID-19 vaccine in tribal and rural populations in Maharashtra, India. Methodology: The present study is a cross-sectional analysis of data collected from 373 individuals from six villages (three tribal and three rural) from August 2022 to September 2022. Demographic information, COVID-19 history, details about vaccination, and reasons for taking/not taking the vaccine were collected. Results: In these individuals, 236 (63.3%) had taken two doses, 85 (22.8%) had taken one dose, and 52 (13.9%) had not taken the vaccine. Tribal villagers were less likely to have completed vaccination (50.7% vs 79.3%; p < 0.001). Males were more likely to state 'compulsory at my workplace' (27.7% vs 7.7%; p < 0.001), whereas females were more likely to report 'could not get ration food without it' (52.7% vs 31.5%; p < 0.001) as the reason for vaccination. Common reasons for not taking the vaccine were: fear of side effects (56%); no need for vaccination (41.2%); do not trust the vaccines (40%); and 'there is no such thing as COVID-19'(16%). A majority (94.7%) had completed COVID-19 vaccination at government vaccination centers. Conclusions: Tribal villagers, women, and those from lower socioeconomic status were less likely to have taken the vaccine. Fear about side effects and mistrust about vaccines were the main reasons for not having taken the vaccine. Addressing these issues in mass information campaigns may help improve vaccination coverage. [ABSTRACT FROM AUTHOR]

Background: Knowledge of factors associated with TB mortality during treatment and post treatment will help us develop better monitoring and implementation strategies for TB control. We designed the present study to examine the factors associated with mortality in HIV‐TB co‐infected patients during and after the course of TB treatment. Methods: This study is a cohort analysis of secondary data collected from 1804 HIV‐TB co‐infected individuals from 16 anti‐retroviral therapy (ART) centres affiliated with the Mumbai Districts AIDS Control Society, Mumbai, India. We used Kaplan Meier survival curves and hazard ratios to estimate the mortality in patients. Results: The overall mortality rate in this cohort was 1.14 per 100 per month. The mortality proportion was 18% (95% CI: 16.1%, 20.1%) during treatment and 10.6% (95% CI: 8.9%, 12.5%) in the post‐treatment period. Mortality was significantly higher in those with a CD4 count 0–200 cells/mm3 (HR: 3.04, 95% CI: 2.13, 4.15; p < 0.001), and in patients who were ART naïve and referred to the ART centre with a diagnosis of TB (HR: 1.39, 95% CI: 1.06, 1.82; p = 0.016). Mortality was also significantly higher in the first 6 months after initiation of ART (HR: 1.36, 95% CI: 1.06, 1.75; p = 0.016). A decrease in the CD4 counts from initial levels at start of TB treatment to end of TB treatment was associated with higher mortality in the post‐treatment period. Discussion: The overall mortality remains high; early identification of TB and HIV disease, and use of rapid point of care tests for diagnosis of TB are needed across all health care facilities. Post‐treatment follow‐up and monitoring is important in HIV‐TB co‐infected patients, and post‐treatment mortality should also be considered as one of the indicators for successful TB control programmes. [ABSTRACT FROM AUTHOR]

Background: It is important to understand the current internet-related sexual behaviours of high-risk groups such as men who have sex with men (MSM). We designed the present study to understand the types of online/mobile apps used by MSM and male-to-female transgendered people/hijras [TGH] in Mumbai, India. We also compared the internet-related 'partner seeking' and 'sexual behaviours' in MSM and TGH in Mumbai, India. Methods: This is a cross-sectional analysis of secondary data collected (April to June 2020) from 8582 MSM and 4163 TGH from five targeted intervention programmes each in Mumbai, Maharashtra, India. Data on demographics, years of association with the intervention, number and type of online/mobile apps used, sexual behaviours including partners from virtual space and non-virtual (physical) space, group sex, attending parties, mobility for sexual partners, and HIV status were collected. Results: MSM were more likely to have mobile phone (88% vs 51%, p < 0.001) and internet access over the phone (78% vs 27%; p < 0.001) compared with TGH. The common apps used by MSM were Grindr (48%), Facebook (42%), and Blued (36%). MSM were more likely to have partners from virtual space (91% vs 67%; p < 0.001). A higher proportion of MSM had attended parties (28% vs 2%; p < 0.001), had group sex (16% vs 6%; p < 0.001), and were mobile for sex (25% vs 4%). MSM and TGH who had partners from virtual space were significantly more likely to report 'missed a condom at least once during penetrative sex in the past one week' (17% vs 12%; p<0.001). In HIV positive MSM, group sex, parties, and mobility for sex, were only in those who reported partners from the virtual space. Conclusions: Internet-based interventions for MSM should be incorporated in the existing targeted intervention programme and outreach workers should be trained in virtual outreach services. Among TGH, given the low reach and use of smartphones and apps, internet-based interventions may not be such a useful option, and the existing physical targeted intervention programmes should be strengthened. [ABSTRACT FROM AUTHOR]

Background: India started its vaccination programme for Coronavirus-19 infection (COVID-19) on 16 January 2021 with CovishieldTM (Oxford/Astra Zeneca vaccine manufactured by Serum Institute of India) and Covaxin ® (Bharat Biotech, India). We designed the present study to study the effectiveness of vaccines for COVID-19 in prevention of breakthrough infections and severe symptomatic cases among health care workers in a real-life scenario in Mumbai, India. Furthermore, we also wanted to study the factors associated with this effectiveness. Methods: This is cohort analysis of secondary data of 2762 individuals working in a tertiary health care setting in Mumbai, India (16 January 2021 to 16 October 2021). Vaccination records of all groups of health care staff (including the date of vaccination, type of vaccine taken, and date of positivity for COVID-19) were maintained at the hospital. The staff were tested for COVID-19 at least once a week and when symptomatic. The observation time for everyone was divided into unvaccinated, partially vaccinated (14 days after the first dose); and fully vaccinated (14 days after the second dose). If the individual was found to be positive, the day of positivity was considered the 'day of the event' for that individual. We combined unvaccinated/partially vaccinated into one group and completely vaccinated in the other group. We estimated hazard ratios (HR) and their 95% confidence intervals. The vaccine effectiveness (VE) was assessed as (1-HR)*100. Results: The mean age (SD) of the study participants was 32.3 (8.3) years; majority of these individuals had taken Covishield TM (99.0%) and only 0.9% (n = 27) had taken Covaxin ®. The incidence rate in the overall population was 0.067/100 person-days (PD). The incidence rate was significantly higher in the unvaccinated/partially vaccinated group compared with the fully vaccinated group (0.0989 / 100 PD vs 0.0403/100 PD; p < 0.001). The adjusted HR (aHR) in the fully vaccinated group compared with the unvaccinated/partially vaccinated group in the complete cohort was 0.30 (95% CI: 0.23, 0.39). Thus, the vaccine effectiveness (VE) for full vaccination was 70% (95% CI: 61%, 77%). It remained the same in the Covishield TM only cohort. The VE in completely vaccinated and with a history of previous infection was 88% (95% CI: 80%, 93%). Only 11 health care workers required hospitalization over the entire observation period; the incidence rate in our cohort was 0.0016 / 100 PD. None of the HCWs reported any severe adverse events after vaccination. Conclusions: In this real-world scenario, we did find that complete vaccination reduced the rate of infection, particularly severe infection in health care personnel even during the severe delta wave in the country. Even among those infected, the hospitalisation rates were very low, and none died. We did not record any major side effects of vaccination in these personnel. Previous infection with COVID-19 and complete vaccination had a significantly higher effectiveness in prevention of infection. [ABSTRACT FROM AUTHOR]

Purpose: Presence of diabetes in glaucoma patients may influence findings while documenting the progression of glaucoma. We conducted the study to compare individual and combined effects of diabetes and glaucoma on macular thickness and ganglion cell complex thickness. Methods: The present study is a cross-sectional analysis of 172 eyes of 114 individuals. The groups were categorized according to the following conditions: glaucoma, diabetes mellitus, both glaucoma and diabetes ('both' group), and none of these conditions ('none' group). Patients with diabetes did not have diabetic retinopathy (DR). We compared retinal nerve fiber layer (RNFL) thickness, ganglion cell complex (GCC) thickness, foveal loss of volume (FLV), and global loss of volume (GLV) among the groups. We used random effects multivariate analysis to adjust for potential confounders. Results: The mean (SD) age of these individuals was 60.7 (10.1) years. The total average RNFL and GCC were significantly lower in the glaucoma group (RNFL: -36.27, 95% confidence intervals [CI]: -42.79 to -29.74; P <0.05, and GCC: -26.24, 95% CI: -31.49 to -20.98; P<0.05) and the 'both' group (RNFL: -24.74, 95% CI: -32.84 to -16.63; P<0.05, and GCC: -17.92, 95% CI: -24.58 to -11.26; P<0.05) as compared with the 'none' group. There were no significant differences in the average RNFL values and total average GCC between the diabetes group and the 'none' group. The values of FLV and GLV were significantly higher in the 'glaucoma' group and the 'both' group as compared with the 'none' group. The foveal values were not significantly different across these four groups. Among the glaucoma cases, 25% were mild, 30% were moderate, and 45% were severe; there was no significant difference in the proportion of severity of glaucoma between the 'glaucoma only' and 'both' groups (p=0.32). After adjusting for severity and type of glaucoma, there were no statistically significant differences in the values of average RNFL (6.6, 95% CI: -1.9 to 15.2; P=0.13), total average GCC (3.6, -95% CI: -2.4 to 9.6; P=0.24), and GLV (-3.9, 95% CI: -9.5 to 1.6; P=0.16) in the 'both group' as compared with the glaucoma only group. Conclusion: We found that diabetes with no DR did not significantly affect the retinal parameters in patients with glaucoma. Thus, it is less likely that thickness of these parameters will be overestimated in patients with glaucoma who have concurrent diabetes without retinopathy. [ABSTRACT FROM AUTHOR]

Background: People with Advanced HIV Disease (AHD) are at higher risk of TB coinfection and mortality. However, there are challenges in TB diagnosis with the currently recommended diagnostic tools. WHO recommends lateral flow urine lipoarabinomannan (LF-LAM) assay to assist TB diagnosis among AHD patients. We assessed the utility and acceptability of using urine LF-LAM assay for TB diagnosis among patients at public Antiretroviral Therapy (ART) Centres in Mumbai. Methods: The cross-sectional study was conducted among adult AHD patients accessing care from 17 ART centres during November,2020-June, 2021. Urine LF-LAM was offered as routine care for eligible patients in combination with standard diagnostic tests. We calculated the proportion of positive LF-LAM results by CD4 categories and TB symptoms and performed multivariable logistic regression to determine the factors associated with LF-LAM positivity. Results: Among 2,390 patients, the majority (74.5%) had CD4 between 101–200 cells/mm3. The mean age was 43.7 years (SD:10.6), 68.6% were male, 8.4% had TB symptoms and 88.0% were on ART. The overall proportion of patients with urine LF-LAM positive results was 6.4%. Among PLHIV with CD4≤100 cells/mm3, the positivity was 43.0% and 7.7% in symptomatic and asymptomatic patients, respectively. Among PLHIV with a CD4>100 cells/mm3, the positivity was 26.7% and 2.7% in symptomatic and asymptomatic patients respectively. Urine LF-LAM positivity was higher among inpatients, ART naïve, patients on treatment for <6 months, symptomatic and in WHO clinical stage III/IV of HIV disease as compared to the reference categories. We detected an additional 131 TB cases with urine LF-LAM in combination with the standard diagnostic tests. Conclusion: The study demonstrated the utility of urine LF-LAM for TB diagnosis among AHD patients and the simple, user-friendly test was acceptable as part of routine care. Inclusion of urine LF-LAM test in the current diagnostic algorithm may facilitate early TB diagnosis among AHD patients. [ABSTRACT FROM AUTHOR]

Introduction: Pyogenic granulomas are benign vascular lesions of the skin and mucosa which are often a source of concern because of their recurrent bleeding even with minimal trauma. Current treatment for pyogenic granuloma is ablative; no medical therapy is standardized to date. Timolol, due to its vasoconstrictive effect, vascular growth factor inhibition and apoptosis promotion properties, is a potential therapeutic option. Objectives: To assess the effectiveness and safety of topical timolol in the treatment of pyogenic granulomas. Methods: A two-centre, double-blind and placebo-controlled trial (Registration CTRI/2019/04/018581) was conducted. Patients of either sex were recruited with pyogenic granuloma lesions of less than eight weeks duration. Topical treatment with 0.5% timolol or matching glycerin placebo was continued for six weeks. Changes in color, size, bleeding tendency, physicians’ and patients’ global assessments and adverse events were assessed. Results: Forty subjects were randomized between the two groups which were comparable in age, sex, duration of illness and baseline lesion size. Significant improvement was noted with timolol, with color change from first follow-up onwards and lesion size reduction from second follow-up onward. Patients’ assessment of bleeding tendency also showed imrovement from the second visit onward. Between-group comparison showed significant difference with respect to percentage reduction in size (timolol 40.9%, placebo 3.4%; P = 0.002). Rescue treatment (electrosurgery) was required in five patients on placebo and in one in the timolol group (P = 0.182). Complete resolution occurred in 2 (10%) patients with timolol and in no patients on placebo (P = 0.231). Limitations: We observed effects of treatment for only six weeks. Conclusion: Topical timolol may be a treatment option for early pyogenic granulomas but complete resolution is unlikely in six weeks. Studies of longer duration are required to assess resolution and recurrence rates. [ABSTRACT FROM AUTHOR]

Background: The Pediatric HIV Telemedicine Initiative is a video-linked delivery of expert services, designed to reach those previously unable to access expert HIV care. The present qualitative study was designed to understand the acceptability of telemedicine [TM] by patients, their caregivers and health care providers in the anti-retroviral therapy (ART) centers in Maharashtra. Methods: We conducted focus group discussions with caregivers at six ART centres (three linked with TM facilities and three not linked with TM). We also conducted in-depth interviews with medical officers, counselors, and pharmacists at each centre. The data from the interviews were transcribed and translated into English for analysis. The qualitative data were analyzed using thematic framework approach. Results: Children and caregivers who had participated in telemedicine consultation through video conference found the process acceptable, were comfortable communicating during these sessions, and did not have any specific problem to report. The advantages of TM were: consultation without having to travel to other cities; economic advantage; and prompt consultation. The total time spent during the process and technical difficulties during the TM sessions were some of the challenges. The medical officers had the opportunity to discuss difficult cases with the expert during the TM session. Some sessions were also considered a 'group counseling' session, wherein several children and caregivers were able to interact and learn from each other and motivate each other. The health care providers at the three centers that did not currently have TM facilities expressed a desire to have these services at their centers as well. According to them, these facilities will help them address complicated and difficult pediatric HIV cases. Currently, they send their patients to referral centers or other hospitals. Since, many of these referral hospitals are situated in bigger cities, less than 50% of patients access care at these centers This is mostly due to the time constraints and finances (travel/stay) required for accessing these centres. Discussion: TM was a feasible, acceptable, and desired approach for care of children living with HIV/AIDS. It provides support to their caregivers as well as their care providers. The ART staff from the telemedicine-linked peripheral centers were supportive of the use of TM and wanted these services to be initiated in the non-linked centers. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the diagnostic test properties of the Palm Scan VF2000® Virtual Reality Visual Field Analyzer for diagnosis and classification of the severity of glaucoma. Methods: This study was a prospective cross-sectional analysis of 166 eyes from 97 participants. All of them were examined by the Humphrey® Field Analyzer (used as the gold standard) and the Palm Scan VF 2000® Virtual Reality Visual Field Analyzer on the same day by the same examiner. We estimated the kappa statistic (including 95% confidence interval [CI]) as a measure of agreement between these two methods. The diagnostic test properties were assessed using sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Results: The sensitivity, specificity, PPV, and NPV for the Virtual Reality Visual Field Analyzer for the classification of individuals as glaucoma/non-glaucoma was 100%. The general agreement for the classification of glaucoma between these two instruments was 0.63 (95% CI: 0.56-0.78). The agreement for mild glaucoma was 0.76 (95% CI: 0.61-0.92), for moderate glaucoma was 0.37 (0.14-0.60), and for severe glaucoma was 0.70 (95% CI: 0.55-0.85). About 28% of moderate glaucoma cases were misclassified as mild and 17% were misclassified as severe by the virtual reality visual field analyzer. Furthermore, 20% of severe cases were misclassified as moderate by this instrument. Conclusion: The instrument is 100% sensitive and specific in detection of glaucoma. However, among patients with glaucoma, there is a relatively high proportion of misclassification of severity of glaucoma. Thus, although useful for screening of glaucoma, it cannot replace the Humphrey® Field Analyzer for the clinical management in its current form. [ABSTRACT FROM AUTHOR]

Introduction: Brucellosis is a highly infectious zoonosis affecting humans and animals. It is a multi-burden disease leading to severe economic losses due to disability in humans, and it also causes abortion, infertility, and reduced milk production in animals. An essential element for effective prevention and control of brucellosis is to improve Knowledge, Attitude and Practice (KAP) of the community. Aim: To evaluate KAP for human brucellosis to determine the risk factors among Migratory Animal Handlers (MAH) in Nagpur and Chandrapur district of Maharashtra state in India. Materials and Methods: A cross-sectional study was conducted on 143 subjects chosen randomly from Nagpur and Chandrapur districts, Maharashtra. A structured and validated questionnaire was used for demographic characteristics and KAP. Data was entered in Microsoft Excel and analysed by SPSS. Descriptive statistics accustomed to demographic feature and KAP. Results: All 143 respondents (87 from Nagpur and 56 from Chandrapur) were males. Age ranged from 20 to 50 years. The majority of 139 (97%) respondents were married. Of 143 respondents, none had heard of brucellosis, 125 (87%) consumed unpasteurised milk, 37 (26%) assisted during calving, and 34 (24%) milking the animal. None of the respondents used protective clothing while assisting in animal delivery or handling birth products. One hundred and thirty six (95%) respondents informed that they treated the animal without consulting a veterinarian. Conclusion: This study showed poor knowledge and high-risk behaviours and self-reported practices for brucellosis among MAH. Public health education for MAH should be enhanced with full capacity as an integral part of the National Control Program on Brucellosis in India. [ABSTRACT FROM AUTHOR]

Background. The National AIDS Control Organization (NACO) of India created the Regional Pediatric Antiretroviral Therapy (ART) Center; this was subsequently upgraded to seven Pediatric Centers of Excellence (PCoEs) to strengthen the quality of treatment and care of children living with HIV/AIDS (CLHAs). In October 2013, the pediatric HIV telemedicine initiative, an e-decentralized (care provided by local healthcare providers and support provided by a central agency through telemedicine facilities) model of expert pediatric HIV care and referral services, was established as a pilot project at the Pediatric Center of Excellence for HIV Care in Maharashtra. We designed the present study to compare management, compliance to ART, and mortality in children in the ART centers linked to the PCoE through telemedicine versus those that are not linked to the PCoE. Methods. It was a retrospective cross-sectional study of secondary data from CLHAs from October 2013 through August 2015 in the ART centers to document the intermediate outcomes and to determine if the initiative has improved the quality of care for the CLHAs enrolled in the linked ART centers with nonlinked ART centers. The centers in which the telemedicine sessions were conducted regularly were called linked-regular centers and in whom it was conducted irregularly (less than the median of 12 videoconference cases), it was called a linked-irregular center. Data from 2803 children in 31 linked (1365 in irregular and 1438 in regular centers) and 2608 children in 28 nonlinked centers were analyzed. The outcomes in children in the pre-ART group (ART naïve) were (1) alive on pre-ART, (2) lost to follow-up on pre-ART, (3) death during the pre-ART period, (4) eligible but not initiated on ART, and (5) missing baseline and latest CD4 counts. The outcomes of children on ART were (1) alive on ART, (2) lost to follow-up on ART, (3) death on ART, and (4) missing baseline and latest CD4 counts. Results. We found that a higher proportion of children in the linked-regular centers (79% vs. 70%, p < 0.001) and linked-irregular centers (76% vs. 70%, p = 0.04) was alive compared with that in the nonlinked centers in the pre-ART group. In this group, the proportion of children with missing baseline CD4 counts and latest CD4 counts was significantly low in linked (regular centers) centers. In the ART group, we found that a higher proportion of children in the linked-regular centers was alive compared with that in the linked-irregular centers (77% vs. 69%, p < 0.001); the proportion was not significantly different in nonlinked centers (77% vs. 78%, p = 0.56). In this group, the proportion of missing baseline CD4 counts was significantly lower in the linked-regular centers (3% vs 13%, p<0.001) and linked-irregular centers (1% vs. 13%, p < 0.001) compared with that in the nonlinked centers. Furthermore, the latest CD4 counts were missing in a significantly lower proportion of children in the linked-regular centers compared with those in the linked-irregular centers (6% vs. 18%, p < 0.001) and nonlinked centers (6% vs. 18%, p < 0.001). Conclusion. Our study shows that the centers linked through telemedicine performed better in terms of patient care and treatment, with a lesser loss to follow-up and lesser deaths in CLHA. Overall, this pilot project of telemedicine for pediatric HIV has been proven to be acceptable, feasible, and effective in improving the quality of care for children living with HIV across the state of Maharashtra. [ABSTRACT FROM AUTHOR]

Background: India has recently introduced telemedicine initiatives to enhance access to specialized care at a low cost for the pediatric HIV patients, who face multiple challenges due to growing disease burden and limited preparedness of the health system to address it. There are limited evidences on the cost-effectiveness of these interventions. This study was undertaken in Maharashtra, a province, located in the western region of the country, to inform policy regarding the effectiveness of this programme. The objective was to estimate the unit cost of ART services for pediatric HIV patients and examine the efficiency in the use of resource and treatment compliance resulting from telemedicine initiatives in pediatric HIV compared to usual ART services. Methods: We selected 6 ART centers (3 from linked centers linked to Pediatric HIV Centre of Excellence (PCoE) and 3 from non-linked centers) randomly from three high, middle and low ART centers, categorized on the basis of case load in each arm. A bottom up costing methodology was adopted to understand the unit cost of services. Loss to follow up and timeliness of the visits were compared between the two arms and were linked to the cost. Results: The average cost per-visit was INR 1803 in the linked centers and that for the non-linked centers was INR 3412. There has been 5 percentage point improvement in lost to follow-up in the linked centers compared to non-linked centers against a back-drop of a reduction in per-pediatric patient cost of INR 557. The linkage has resulted in increase in timeliness of the visits in linked centers compared to non-linked centers. Discussion and conclusion: The telemedicine linkage led to an increase in the case load leading to a decrease in cost. The evidence on efficiency in the use of resource and improvement in treatment compliance as suggested by this study could be used to scale up this initiative. [ABSTRACT FROM AUTHOR]

This concluding module attempts to synthesize the key learning points discussed during the course of the previous ten sets of modules on methodology and biostatistics. The objective of this module is to discuss how to present a model research proposal, based on whatever was discussed in the preceding modules. The lynchpin of a research proposal is the protocol, and the key component of a protocol is the study design. However, one must not neglect the other areas, be it the project summary through which one catches the eyes of the reviewer of the proposal, or the background and the literature review, or the aims and objectives of the study. Two critical areas in the "methods" section that cannot be emphasized more are the sampling strategy and a formal estimation of sample size. Without a legitimate sample size, none of the conclusions based on the statistical analysis would be valid. Finally, the ethical parameters of the study should be well understood by the researchers, and that should get reflected in the proposal. [ABSTRACT FROM AUTHOR]

Although quantitative designs are commonly used in clinical research, some studies require qualitative methods. These designs are different from quantitative methods; thus, researchers should be aware of data collection methods and analyses for qualitative research. Qualitative methods are particularly useful to understand patient experiences with the treatment or new methods of management or to explore issues in detail. These methods are useful in social and behavioral research. In qualitative research, often, the main focus is to understand the issue in detail rather than generalizability; thus, the sampling methods commonly used are purposive sampling; quota sampling; and snowball sampling (for hard to reach groups). Data can be collected using in-depth interviews (IDIs) or focus group discussions (FGDs). IDI is a one-to-one interview with the participant. FGD is a method of group interview or discussion, in which more than one participant is interviewed at the same time and is usually led by a facilitator. The commonly used methods for data analysis are: thematic analysis; grounded theory analysis; and framework analysis. Qualitative data collection and analysis require special expertise. Hence, if the reader plans to conduct qualitative research, they should team up with a qualitative researcher. [ABSTRACT FROM AUTHOR]

This article is a continuation of the previous module on designing questionnaires and clinical record form in which we have discussed some basic points about designing the questionnaire and clinical record forms. In this section, we will discuss the reliability and validity of questionnaires. The different types of validity are face validity, content validity, criterion validity, and construct validity. The different types of reliability are test-retest reliability, inter-rater reliability, and intra-rater reliability. Some of these parameters are assessed by subject area experts. However, statistical tests should be used for evaluation of other parameters. Once the questionnaire has been designed, the researcher should pilot test the questionnaire. The items in the questionnaire should be changed based on the feedback from the pilot study participants and the researcher's experience. After the basic structure of the questionnaire has been finalized, the researcher should assess the validity and reliability of the questionnaire or the scale. If an existing standard questionnaire is translated in the local language, the researcher should assess the reliability and validity of the translated questionnaire, and these values should be presented in the manuscript. The decision to use a self- or interviewer-administered, paper- or computer-based questionnaire depends on the nature of the questions, literacy levels of the target population, and resources. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

In this module, we have discussed study designs that have not been covered in the previous modules -- ecologic studies and natural experiments. In an ecologic study, the unit of analysis is a group or aggregate rather than the individual. It may be the characteristics of districts, states, or countries. For example, per capita income across countries, income quintiles across districts, and proportion of college graduates in states. If the data already exist (such as global measures and prevalence of diseases, data sets such as the National Family Health Survey, census data), then ecologic studies are cheap and data are easy to collect. However, one needs to be aware of the "ecologic fallacy." The researcher should not interpret ecologic level results at the individual level. In "natural experiments," the researcher does not assign the exposure (as is the case in interventional studies) to the groups in the study. The exposure is assigned by a natural process. This may be due to existing policies or services (example, one city has laws against specific vehicles and the other city does not); changes in services or policies; or introduction of new laws (such helmet for bikers and seat-belts for cars). We would like to encourage researchers to explore the possibility of using these study designs to conduct studies. [ABSTRACT FROM AUTHOR]

Systematic reviews and meta-analysis have become an important of biomedical literature, and they provide the "highest level of evidence" for various clinical questions. There are a lot of studies -- sometimes with contradictory conclusions -- on a particular topic in literature. Hence, as a clinician, which results will you believe? What will you tell your patient? Which drug is better? A systematic review or a meta-analysis may help us answer these questions. In addition, it may also help us understand the quality of the articles in literature or the type of studies that have been conducted and published (example, randomized trials or observational studies). The first step it to identify a research question for systematic review or meta-analysis. The next step is to identify the articles that will be included in the study. This will be done by searching various databases; it is important that the researcher should search for articles in more than one database. It will also be useful to form a group of researchers and statisticians that have expertise in conducting systematic reviews and meta-analysis before initiating them. We strongly encourage the readers to register their proposed review/meta-analysis with PROSPERO. Finally, these studies should be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis checklist. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Neonates and infants with hypomagnesemia present with seizures and psychomotor delay. Objectives: The present study evaluated the changes in magnesium (Mg) levels and factors associated with these in the first three days of life. Materials and Methods: We monitored 50 clinically asymptomatic neonates; they were not given any magnesium supplements even if they had hypomagnesemia at baseline. The variables analysed were: serum Mg; gestational age; birth weight; length; and the ponderal index. We used random effects (RE) models for longitudinal analysis of these data. Results: The mean standard deviation (SD) gestational age was 36.3 (3.6) weeks and the mean (SD) weight was 2604.2 (754.4) grams. About 31% of the neonates had hypomagnesemia (< 1.6 mg/dL) on day one; however, all had normal magnesium levels by day three of life (P < 0.001). At birth, after adjusting for intrauterine growth retardation status (IUGR), serum Mg levels were lower by 0.0097 mg/dL (95% CI: -0.019 to -0.0003) per 100 grams increase in weight of the neonate. After adjusting for IUGR status, the mean increase in the serum Mg levels was 0.14 mg/dL (95% confidence intervals [CI]: 0.10 to 0.18) per day. The per-day increase in magnesium levels was significantly higher in low birth weight babies (0.10, 95% CI: 0.01 to 0.18) compared with normal birth weight babies. Conclusions: Asymptomatic neonates may have a high prevalence of hypomagnesemia; however, the levels become normal without any magnesium supplementation. Even though regular monitoring of magnesium levels is useful, no supplements are required - particularly in clinically asymptomatic neonates. [ABSTRACT FROM AUTHOR]

Cohort design is a type of nonexperimental or observational study design. In a cohort study, the participants do not have the outcome of interest to begin with. They are selected based on the exposure status of the individual. They are then followed over time to evaluate for the occurrence of the outcome of interest. Some examples of cohort studies are (1) Framingham Cohort study, (2) Swiss HIV Cohort study, and (3) The Danish Cohort study of psoriasis and depression. These studies may be prospective, retrospective, or a combination of both of these types. Since at the time of entry into the cohort study, the individuals do not have outcome, the temporality between exposure and outcome is well defined in a cohort design. If the exposure is rare, then a cohort design is an efficient method to study the relation between exposure and outcomes. A retrospective cohort study can be completed fast and is relatively inexpensive compared with a prospective cohort study. Follow-up of the study participants is very important in a cohort study, and losses are an important source of bias in these types of studies. These studies are used to estimate the cumulative incidence and incidence rate. One of the main strengths of a cohort study is the longitudinal nature of the data. Some of the variables in the data will be time-varying and some may be time independent. Thus, advanced modeling techniques (such as fixed and random effects models) are useful in analysis of these studies. [ABSTRACT FROM AUTHOR]

Background: Pressure ulcers (PUs) are prevalent in hospitalized patients; they may cause clinical, psychological, and economic problems in these patients. Previous studies are cross‑sectional, have used pooled data, or cox‑regression models to assess the risk for developing PU. However, PU risk scores change over time and models that account for time varying variables are useful for cohort analysis of data. Aims and Objectives: The present longitudinal study was conducted to compare the risk of PU between surgical and nonsurgical patients, and to evaluate the factors associated with the development of these ulcers over a period of time. Materials and Methods: We evaluated 290 hospitalized patients over a 4 months period. The main outcomes for our analysis were: (1) Score on the pressure risk assessment scale; and (2) the proportion of individuals who were at severe risk for developing PUs. We used random effects models for longitudinal analysis of the data. Results: The mean PU score was significantly higher in the nonsurgical patients compared with surgical patients at baseline (15.23 [3.86] vs. 9.33 [4.57]; P < 0.01). About 7% of the total patients had a score of >20 at baseline and were considered as being at high‑risk for PU; the proportion was significantly higher among the nonsurgical patients compared with the surgical patients (14% vs. 4%, P = 0.003). In the adjusted models, there was no difference for severe risk for PU between surgical and nonsurgical patients (odds ratios [ORs]: 0.37, 95% confidence interval [CI]: 0.01-12.80). An additional day in the ward was associated with a significantly higher likelihood of being at high‑risk for PU (OR: 1.47, 95% CI: 1.16-1.86). Conclusion: There were no significant differences between patients who were admitted for surgery compared with those who were not. An additional day in the ward, however, is important for developing a high‑risk score for PU on the monitoring scale, and these patients require active interventions. [ABSTRACT FROM AUTHOR]

Background. Vitiligo has important clinical and social consequences particularly in the pigmented skin. The present study was conducted to assess the differences in clinicoepidemiological presentation of vitiligo in males and females and to understand the factors associated with spread of vitiligo in them. Methods. This is a cross-sectional analysis of secondary clinical data of 168 vitiligo patients at a tertiary medical centre at Navi Mumbai. We used logistic regression models to estimate the association between gender and clinical characteristics of vitiligo and to evaluate the factors associated with spread of vitiligo. Results. There were no significant differences between the mean ages of males and females; however, males reported a longer duration of disease (6.9 (10.4) years) compared with females (4.9 (7.4) years). Males were significantly more likely to report a family history of vitiligo compared with females (adjusted OR (aOR): 16.87, 95% CI: 2.16 to 131.69). Even though females were more likely to report spread of lesions, the association was not statistically significant (OR: 1.21, 95% CI: 0.62 to 2.36). Discussion. The differences in the clinical presentations between genders highlight the need to understand the different factors (possibly genetic) that may play a part in the pathogenesis of this multifactorial disease in males and females. [ABSTRACT FROM AUTHOR]

This study aimed to review the evidence on the efficacy of herbal preparations containing black cohosh for the treatment of menopausal symptoms. A systematic search of three databases (PubMed, Embase, and Cochrane library) was conducted to identify relevant literature. Two reviewers independently abstracted the data from the eligible studies. Of the 288 English language citations screened, nine randomized placebo-controlled trials were included. Among these trials, six demonstrated a significant improvement in the black cohosh group compared with the placebo group. Using data from seven trials, we calculated a combined estimate for the change in menopausal vasomotor symptoms. Preparations containing black cohosh improved these symptoms overall by 26% (95% confidence interval 11%-40%); there was, however, significant heterogeneity between these trials. Given that black cohosh is one of the most frequently used herbal medications for menopausal vasomotor symptoms in North America, more data are warranted on its effectiveness and safety. [ABSTRACT FROM AUTHOR]

Background: Male sex workers (MSWs) have recently been recognized as an important risk group for sexually transmitted infections (STIs) including human immunodeficiency virus (HIV) infection. Although there are global studies on MSWs, few such studies describe the behavioral patterns and STIs among this population in India. Methods: MSWs were evaluated at the Humsafar trust, a community based organization situated in suburban Mumbai, India. We report on the demographics, sexual behaviors, and STIs including HIV of these sex workers. Results: Of the 75 MSWs, 24 were men and 51 were transgenders. The mean age of the group was 23.3 (+ 4.9) years. About 15% were married or lived with a permanent partner. Of these individuals, 85% reported sex work as a main source of income and 15% as an additional source. All the individuals reported anal sex (87% anal receptive sex and 13% anal insertive sex). About 13% of MSWs had never used a condom. The HIV prevalence was 33% (17% in men vs 41% in transgenders, P = 0.04). The STI prevalence was 60% (58% in men vs 61% in transgenders, P = 0.8). Syphilis was the most common STI (28%) in these MSWs. HIV was associated with being a transgender (41 vs 17%, P = 0.04), age > 26 years (57 vs 28%, P = 0.04), more than one year of sex work (38 vs 8%, P = 0.05), and income < Rs. 2000 per month (62 vs 27%, P = 0.02). Conclusions: The MSWs have high-risk behaviors, low consistent condom use, and high STI/HIV infections. These groups should be the focus of intensive public health interventions aimed at reduction of risky sexual practices, and STI/ HIV prevention and care. [ABSTRACT FROM AUTHOR]

The article provides an overview of different types of observational studies in clinical research. The three types of observational studies are cross-sectional studies, case-control studies and cohort studies. A brief description of the methods involved, advantages and potential limitations and the types of analyses used in each study is provided.

This study systematically reviews the existing literature on sexually transmitted infections (STIs) including human immunodeficiency virus (HIV) infection in the men who have sex with men (MSM) in India. After a comprehensive literature search of Medline (1950-June 2008), Embase (1980-June 2008), and the Cochrane Library (1950-June 2008), 12 published studies met the inclusion criteria. The link between sexual identity and sexual behavior is a complex phenomenon strongly embedded in a very specific context in India. MSM in India are an important risk group for acquiring STIs/HIV and effective culturally sensitive prevention programs should be designed for them. The combined estimate of HIV prevalence in theMSM population in India calculated from 5 included studies was 16.5% (95% confidence intervals: 11% to 22%). The review also identifies the lacunae in existing literature and provides future directions for research in the MSM community in India. [ABSTRACT FROM AUTHOR]

Background: Men who have sex with men and transgenders are an important risk group for sexually transmitted infections (STIs) and human immunodeficiency virus (HIV). They have risky sexual behaviors but low risk perception.Objectives: To assess the sexual behavior, STIs, HIV and identify factors associated with HIV in men who have sex with men (MSM) and transgenders (TGs) in Mumbai.Methods: Participants were enrolled from two clinics in Mumbai. They completed an interviewer-administered questionnaire and were evaluated for STIs and HIV infection.Results: A total of 150 participants, 122 MSM and 28 TGs were evaluated; 17% of MSM and 68% of the TGs were HIV infected. HIV infection in MSM was associated with serological positivity for HSV2 IgG [adjusted odds ratio (aOR), 95% confidence interval (CI): 9.0 (2.2-36.9)], a positive Treponema pallidum hemagglutination assay (TPHA) [aOR (95% CI): 6.0 (1.5-24.0)], greater than five acts of receptive anal sex in the past six months [aOR (95% CI): 4.3 (1.2-15.0)] and per category increase in age (18-24 yrs, 25-29 yrs, > 30 yrs) [aOR (95% CI): 3.1 (1.3-7.1)] in multivariate analysis. Consistent condom use during receptive anal sex in the past six months was low (27%). Many MSM were married (22%) or had sex with females and may act as a 'bridge population'. HIV infection in TGs was associated with a positive TPHA [OR (95% CI): 9.8 (1.5-63.9)] and HSV 2 IgG [OR (95% CI): 6.7 (1.1-40.4)] in univariate analysis.Conclusion: Prior STIs were strongly associated with HIV infection in MSM and TGs. These groups should be the focus of intensive intervention programs aimed at STI screening and treatment, reduction of risky sexual behavior and promotion of HIV counseling and testing. [ABSTRACT FROM AUTHOR]

Background: Though studies have looked at the attitudes of dermatologists towards psychodermatology, few have highlighted the attitudes of pharmacists towards these conditions., Objectives: To study the knowledge, attitudes and practices of pharmacists towards the prescription of psychotropic medications to dermatology patients., Methods: This cross-sectional analysis included 80 pharmacists from Mumbai, India. We used an interviewer-administered questionnaire to collect information from pharmacists on their demographics, psychotropic medications in dermatological patients, knowledge about psychocutaneous conditions and comfort about dispensing these medications., Results: In our study, 37 (46%) of pharmacists received prescriptions of psychotropic drugs from dermatologists; however, 24 (30%) were not comfortable dispensing them. Sixty (75%) pharmacists felt that only psychiatrists should prescribe psychotropic drugs and 37 (46%) felt that they had a right to refuse to dispense prescribed medication; of these, 15 (19%) had actually refused to give medications to patients. Pharmacists who disagreed with the statement that 'the state of mind is associated with medical conditions', were more likely to discourage psychotropic prescription from dermatologists (29% vs 11%, P = 0.04). Pharmacists with experience of more than five years were significantly more likely to refuse to dispense medications (odds ratio: 5.14, 95% confidence interval: 1.02, 25.83; P = 0.047)., Limitations: We did not have a list of all pharmacists in Mumbai; thus, no sampling frame could be applied., Conclusion: Pharmacists do comment on doctors' prescriptions, discourage certain medications and even refuse to dispense them based on their personal opinions. Since they are the last stop for patients between the doctor and the medication, their inclusion (in addition to dermatologists, psychiatrists and psychologists) in integrated awareness, training and care programs would improve the quality of care of patients with psychocutaneous disorders.