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Objectives: To assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa.
Design: Construction and analysis of a comprehensive database of completed randomised controlled clinical trials based on clinicaltrials.gov from 1 January 2005 to 31 December 2010 and drug approval data from 2006 until 2013 for India and South Africa.
Setting: USA, the EU, India and South Africa.
Main outcome measures: Percentage of completed randomised clinical trials for an Investigational Medicinal Product (IMP) leading to new drug approval in India and South Africa.
Results: A total of 622 eligible randomised controlled trials were identified as per search criteria for India and South Africa. Clustering them for the same sponsor and the same Investigational New Drug (IND) resulted in 453 eligible trials, that is, 224 for India and 229 for South Africa. The distribution of the market application approvals between the EU/USA as well as India and South Africa revealed that out of clinical trials with the participation of test centres in India and/or South Africa, 39.6% (India) clinical trials and 60.1% (South Africa) clinical trials led to market authorisation in the EU/USA without a New Drug Application (NDA) approval in India or South Africa.
Conclusions: Despite an increase in clinical trial activities, there is a clear gap between the number of trials conducted and market availability of these new drugs in India and South Africa. Drug regulatory authorities, investigators, institutional review boards and patient groups should direct their efforts to ensuring availability of new drugs in the market that have been tested and researched on their population.
Background: India has the third largest HIV epidemic in the world. The Indian epidemic is characterized by low levels in the general population and elevated concentrations among high-risk groups. The present study was planned to determine the awareness of HIV among students from Mumbai University.
Methods: A cross-sectional study was carried out among students from Mumbai University, India during May–June 2017. Two hundred and fifty students were approached to participate in the study of which 199 agreed to participate (males: 132; females: 67). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23.
Results: Study participants had high knowledge (86%) and attitude score (87%). There was no significant difference between males and female participants for attitude and knowledge, except for one question regarding knowledge about HIV transmission via breastfeeding to child.
Conclusions: Present study showed that there are no misconceptions or negative attitudes regarding HIV among students. A longitudinal study with a larger sample size across India is recommended for further investigation.
Background: Immunization is the most cost-effective intervention for infectious diseases which are the major cause of morbidity and mortality worldwide. There is a scarcity of information on the vaccination status of young adults and the role of socioeconomic conditions in India. Objectives: Present study explored the adult vaccination status and influence of income and education of parents on adult vaccination status in university students from Mumbai, India.
Methods: On the basis of the eligibility criterion 149 students were selected for the present study. A total of 8 vaccines namely Tdap/DTP, Varicella, MMR, Influenza, Pneumococcal, Hepatitis A, Hepatitis B and Meningococcal were included in this study for all the respondents. In addition to these vaccines, Human Papilloma Virus vaccine was also included for female respondents.
Results: There were total of 149 (75 male and 74 females) respondents with the mean age of 21.5 years. The top 3 immunizations were Td/Tdap (97.3%), MMR (66.4%) and Hepatitis B (55%) among the respondents. Only 4 (5.5%) female respondents have been immunized against the HPV. Conclusions: Td/Tdap (97.3%) and MMR (66.4%) coverage was in line with the recommendations. For all the other vaccines the coverage was low varying from 5.5% to 35.4%. The vaccination coverage was better in respondents with higher educated and higher income parents. We suggest that patient education, planning by government for the implementation of policy for adult vaccination and involvement of physicians are must for better adult vaccination coverage.
Immunization is the most cost-effective intervention for infectious diseases, which are the major cause of morbidity and mortality worldwide. Vaccines not only protect the individual who is vaccinated but also reduce the burden of infectious vaccine-preventable diseases for the entire community.
1 Adult vaccination is very important given that >25% of mortality is due to infectious diseases.
2 There is a scarcity of information on the vaccination status of young adults and the role of socioeconomic conditions in India.
The drugs we use to treat any condition – from an innocuous cough to a life-threatening cancer – are the outcome of painstaking human clinical trials. These trials are the only way to credibly determine the safety and efficacy of drugs. In recent years there has been a clear shift in clinical trial sites from core developed countries like USA, European countries to developing countries like India, China, South American countries. This shift is related to challenges and opportunities like costs of trials, recruitment issues, and regulatory challenges in developed vs. developing countries. Developing countries and developed countries have their unique disease burden patterns based on various parameters like but not limited to age, health care facilities, health insurance, sanitary conditions, environmental issues, education, nutrition
and GDP. Previous studies have reported that many of the important global diseases are not much explored in clinical trials and many published clinical trials have very less international health relevance. This study was aimed at finding the correlation between disease burdens, number of clinical trials done and trial success rates. We compared 2005 - 2010 Global Burden of Disease data for Germany, India and number of clinical trials from clinicaltrials.gov database done in the same period. Our findings indicated that there was a good correlation between the disease burden and clinical trials for Germany in 2005 and 2010. For India in 2005 there was a moderate positive correlation, 2010 data showed the improvement in India in terms of match between disease burden and clinical trials. But careful observation of the data shows still a need for more trials on Communicable, maternal, neonatal and nutritional disorders.
Background: Pharmacovigilance (PV); also known as drug safety surveillance, is the science of enhancing patient care and patient safety regarding the use of medicines by collecting, monitoring, assessing, and evaluating information from healthcare providers and patients. Pharmacists are pivotal players in adverse drug event (ADE) monitoring and reporting. However, most pharmacists are unaware or not knowledgeable about the guidelines used by their respective countries’ drug regulatory bodies. It is the need of the hour to train pharmacy students on the concept of pharmacovigilance.
Methods: A cross-sectional study was carried out among pharmacy students from Mumbai University, India during May-June 2017. On the basis of the eligibility criterion 352 students were selected for the present study. Four hundred students were approached to participate in the study of which 201 agreed to participate (males: 179; females: 173). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23.
Results: Overall pharmacovigilance knowledge (44%) and perception (58%) was low among the participants of the present study. Seventy four percent of the participants felt that adverse drug reaction (ADR) reporting should be made compulsory for healthcare professionals. And only 21% agreed that the topic of Pharmacovigilance is well covered in pharmacy curriculum.
Conclusions: Pharmacy council of India, pharmacy teacher’s association and respective pharmacy college should take necessary steps to increase the knowledge and create awareness regarding pharmacovigilance and adverse drug reaction reporting among pharmacy students.
A systematic review of the literature on survey questionnaires to assess self-medication practices
(2017)
Self-medication is of great public health importance as it often bypasses regulatory mechanisms to assure quality of health care. Nevertheless there are no established standards on how to assess self-medication. We therefore intended to systematically retrieve questionnaires and survey tools used to capture self-medication, with the aim to identify the scope of information investigated in this context and commonalities between the tools. We conducted a systematic review of the literature on questionnaires used for self-medication assessment by searching PubMed and Web of Science databases using the combinations of following keywords; self-medication, self-prescription, non-prescription, questionnaire. Truncation was used to ensure retrieval of all possible variations of search terms. The search was limited to articles published between 1st January 2000 and 31st December 2015, human studies and English language. Duplicate and irrelevant studies were excluded from the final review. A total of 158 studies were included in the review. Studies were from diverse geographical locations, most of the studies were from Nigeria 16 (10.1%) followed by India 10 (6.3%) and Iran 8 (5%). Forty-three studies (27.2%) focused on antibiotic self-medication. Majority of the studies (106; 67%) were done with adult populations. The components addressed by the questionnaires covered: reasons for self-medications in 147 (93%) studies, purchasing source in 136 (86%) studies, medical conditions to be treated in 153 (96.8%) studies, adverse events in 67 (42.4%) studies, use of prescribing information in 24 (15.1%) studies and antibiotic resistance awareness in 20 (46.5%) antibiotic studies. For 74 (46.8%) studies, survey questionnaires were self-administered and most studies (57; 36%) were done at homes of respondents. Thirty-seven (23.4%) studies did not report any recall period for self-medication practices. Study response rates varied from 17.9% to 100%, and while validity of the study questionnaire was reported for 100 (63.3%) studies, 15 (9.5%) studies reported reliability test of the study questionnaire. There is a large variety of questionnaires being used for investigating self-medication practices making comparability and meta-analyses very difficult. It is desirable to have a basic set of standardized survey questions on this topic to make available for future research groups in this field.
Monitoring of clinical trials is a fundamental process required by regulatory agencies. It assures the compliance of a center to the required regulations and the trial protocol. Traditionally, monitoring teams relied on extensive on-site visits and source data verification. However, this is costly, and the outcome is limited. Thus, central statistical monitoring (CSM) is an additional approach recently embraced by the International Council for Harmonisation (ICH) to detect problematic or erroneous data by using visualizations and statistical control measures. Existing implementations have been primarily focused on detecting inlier and outlier data. Other approaches include principal component analysis and distribution of the data. Here we focus on the utilization of comparisons of centers to the Grand mean for different model types and assumptions for common data types, such as binomial, ordinal, and continuous response variables. We implement the usage of multiple comparisons of single centers to the Grand mean of all centers. This approach is also available for various non-normal data types that are abundant in clinical trials. Further, using confidence intervals, an assessment of equivalence to the Grand mean can be applied. In a Monte Carlo simulation study, the applied statistical approaches have been investigated for their ability to control type I error and the assessment of their respective power for balanced and unbalanced designs which are common in registry data and clinical trials. Data from the German Multiple Sclerosis Registry (GMSR) including proportions of missing data, adverse events and disease severity scores were used to verify the results on Real-World-Data (RWD).
A decline in the CD4 count is a common feature in HIV/AIDS, suggesting a compromise in immunity of patients. In response, highly active antiretroviral therapy (HAART) is prescribed to slow-down a diminution in the CD4 count and risk of AIDS-related malignancies. However, exercise may improve both the utility and population of innate immune cell components, and may be beneficial for patients with HIV infection. Comparing the effects of different exercises against HAART, on CD4 count, helps in understanding the role and evidence-based application of exercises to ameliorate immune deficiency.
Objective: To determine the burden and factors associated with post-stroke depression in East central Nigeria.
Method: We carried out this cross-sectional study of 50 stroke survivors (mean age=54.8 ± 8.8 years), at the physiotherapy Department of the University of Nigeria Teaching Hospital, Enugu. Data were collected using Becks Depression Inventory , it was analyzed using Z-scores, Chi-square test and univariate logistic regression.
Results: PSD was more common in females (45.45%); middle-age(60%) adults(27-36/47-56 years respectively); living with spouse (45%); left cerebral lesions (40.74%). Self-employed and unemployed (66.67%), respectively. Age was significantly associated with depression (p=0.03), and was related to the risk ofOR3.7 (95% CI 1.1-12.0 )
Conclusion: Age could be a risk factor for PSD, which was more prevalent in the elderly than young/middle-age adults, female gender, left cerebral lesion, complications, cold case; those living with a spouse, self-employed and unemployed.
Ever since the 1996 revision of the Declaration of Helsinki, the World Medical Association has attempted to address ethical and scientific concerns of its diverse stakeholders for Articles 33 (use of placebo) and 34 (posttrial provisions), most recently in 2013. Both are inextricably linked to standard of care, an essential element of any comparative, interventional clinical trial. But has this now 20-year-long ethical debate truly been put to rest? The choice of standard of care in clinical trials remains a complex issue, particularly for comparative trials conducted in emerging countries.
Diabetes is fast gaining the status of a potential epidemic in India, with >62 million individuals currently diagnosed with the disease.1 India currently faces an uncertain future in relation to the potential burden that diabetes may impose on the country. An estimated US$ 2.2 billion would be needed to sufficiently treat all cases of type 2 diabetes mellitus (T2DM) in India.2 Many interventions can reduce the burden of this disease. However, health care resources are limited; thus, interventions for diabetes treatment should be prioritized.
Background: Diabetes is fast gaining the status of a potential epidemic in India, with >62 million individuals currently diagnosed with the disease. India currently faces an uncertain future in relation to the potential burden that diabetes may impose on the country. An estimated US$ 2.2 billion would be needed to sufficiently treat all cases of type 2 diabetes mellitus (T2DM) in India. Many interventions can reduce the burden of this disease. However, health care resources are limited; thus, interventions for diabetes treatment should be prioritized. The present study assesses the cost-effectiveness of antidiabetic drugs in patients with T2DM from Mumbai, India.
Methods: A prospective cross-sectional study was performed to assess the cost-effectiveness of antidiabetic drugs in patients with T2DM. Face-to-face interviews were conducted by using a validated questionnaire in a total of 152 (76 males, 76 females) patients with T2DM from F-North Ward, Mumbai, India. Cost-effectiveness was determined on the basis of cost of antidiabetic drug/s, efficacy, adverse drug reactions, safety of administration, frequency of administration, and bioavailability.
Results: For treatment of T2DM in non-obese participants, Glimepiride+Pioglitazone costed least (`3.7) per unit of effectiveness followed by Glimepiride (`6.6), Gliclazide (`8.1), Repaglinide (`24.5), and Vildagliptin (`45.2). For treatment of T2DM in obese participants, Metformin cost least (` 6.7) per unit of effectiveness followed by Glimepiride + Metformin (`5.9) and Repaglinide (`24.5).
Conclusions: In case of non-obese participants, cost effectiveness and prescribed treatments did not show a match, while for obese participants prescribed treatments were in line with cost effectiveness.
Hypertension is a serious global public health problem. It accounts for 10% of all deaths in India and is the leading noncommunicable disease.1 Recent studies have shown that the prevalence of hypertension is 25% in urban and 10% in rural people in India.2 It exerts a substantial public health burden on cardiovascular health status and health care systems in India.3 Antihypertensive treatment effectively reduces hypertension-related morbidity and mortality.1 The cost of medications has always been a barrier to effective treatment.
Objective: To determine the distribution of symptoms of post-stroke depression (PSD) in relation to some predisposing factors in an African population.
Relevance: Environment is a key determinant of behavior, and varied socio-cultural contexts must have implications for modifiable characteristics (age, duration of the stroke, marital status, type of employment, gender, the location of cerebral lesion and complications) of individuals vulnerable to PSD, which may be targeted to enhance recovery.
Method: This was a cross-sectional observational study of 50 (22 females and 28 males) stroke survivors (mean age=54.76±8.79 years), at the physiotherapy department, the University of Nigeria teaching hospital, Enugu, selected using convenience sampling technique. Data were collected using Becks Depression Inventory and analyzed using Z-score, Chi-square test and univariate logistic regression, at p<0.05.
Results: PSD was more prevalent in females (45.45%); young(100%); middle-age(60%) adults(27-36/47-56 years respectively); living with spouse (45%); left cerebral lesions (40.74%); complications(45%); cold case >3 years(47.05%); self-employed and unemployed (66.67%), respectively. Age was significantly associated with depression (χ2 =4.92,df=1,p=0.03), and was related to the risk of PSD (3.7[1.1-12.0], p=0.03, φ = +0.31, φ2=0.1).
Conclusion: Age could be a risk factor for PSD, which was more prevalent in the elderly than young/middle-age adults, female gender, left cerebral lesion, complications, cold case; those living with a spouse, self-employed and unemployed.
Lack of knowledge regarding antibiotics use has been widely identified as a main reason for inappropriate antibiotics use which leads to antibiotic resistance phenomenon. This study aimed to evaluate the effects of pharmacist-initiated educational intervention on promoting appropriate use of antibiotics and reducing self-medication with antibiotics. A pre and post intervention study using two validated self-administered questionnaires was performed in Yogyakarta province. A-two hour session of course and case discussion was delivered as method of intervention. Pharmacy customers attended Gema Cermat program were invited conveniently to complete both of pre- and post-educational questionnaires. Descriptive presentation was conducted to show scores on questions. Knowledge scores were categorized as poor, adequate and high. Of 268 respondents, 34.22% respondents had poor level of knowledge before receiving educational intervention, but this number decreased into 12.21% after post-interventional phase. Another 28.23% respondents had adequate level of knowledge before and then elevated into 38.28% after receiving education about appropriate use of antibiotics. Pre-education, 37.43% participants had a high level of knowledge about antibiotics use and resistance, whereas after education the number became slightly higher (49.25%). A vast majority of respondents (75.24%) became more aware about appropriate antibiotics practice after receiving educational inter- vention. Overall, didactic educational intervention imposed higher knowledge and better practice regarding antibiotics use (p < 0.05). This study showed that using didactical education intervention towards antibiotics use and resistance can be an initial strategy that led to substantial improvement of appropriate antibiotics use. Further systemic interventions to educate people should be performed and evaluated in order to promote the appropriate use of antibiotics.
Background: Mobile text reminder (SMS) system is considered a viable strategy for targeting/facilitating healthy behavioural change including adherence to prescribed physical exercises (PE) and medication (antiretroviral therapy-ART) which should improve the quality of life (Qol) in people living with HIV/AIDS(PLWHA). Thus, the literature was appraised for evidence of SMS effectiveness in improving ART and PE adherence behaviours and QoL in PLWHA.
Methods: Eight databases–AMED, CINAHL, Cochrane Library, EMBASE, EMCARE, Ovid MEDLINE, PsycINFO, and PubMed-were searched up to December 2020, using the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) protocol.This review included only randomised control trials (RCTs) investigating the effectiveness of SMS in improving QoL or PE or ART adherence behaviour or a combination of these variables in PLWHA >18 years.
Two independent reviewers determined the eligibility of the studies. Data were extracted and the quality of the study was assessed with the Physiotherapy Evidence Database (PEDro) tool. The primary outcomes were ART and PE adherence behaviours while the secondary outcome was QoL.
Result: A pooled estimate of effect was not calculated due to the heterogeneity of methods and outcome measures.
Therefore, a narrative synthesis of ten studies that met the inclusion criteria (n = 1621 participants at study completion) comprising males/females, aged ≥ 18 years, was done. There was a significant improvement in ART adherence behaviour except in three underpowered studies. Only the SMS interventions that were developed using the Starks 3-steps Adherence model was associated with positive outcome. The only study that evaluated QoL was underpowered and reported no significant change while there were no RCTs on PE.
Conclusion: Effects of SMS intervention trends towards a significant improvement in ART adherence behaviour in PLWHA. It is plausible that SMS reminders developed using the broader framework of the interpersonal health behaviour theory(ies) may have positive outcome. Nevertheless, the observed heterogeneity in the methods/outcome measures warrants a cautious interpretation of the findings. There is a lack/paucity of RCTs and therefore no evidence in support of the effectiveness of SMS intervention in improving PE adherence and QoL.
Introduction:
Human Immunodeficiency Virus (HIV) infection remains prevalent co-morbidity, and among fracture patients. Few studies have investigated the role of exercise interventions in preventing bone demineralization in people who have fractures and HIV. If exercise exposed, HIV-infected individuals may experience improved bone health outcomes (BMD), function, quality of life (QoL). The study will aim to assess the impact of home based exercises on bone mineral density, functional capacity, QoL, and some serological markers of health in HIV infection among Nigerians and South Africans.
Methods and design:
The study is an assessor-blinded randomized controlled trial. Patients managed with internal and external fixation for femoral shaft fracture at the study sites will be recruited to participate in the study. The participants will be recruited 2 weeks post-discharge at the follow-up clinic with the orthopaedic surgeon. The study population will consist of all persons with femoral fracture and HIV-positive and negative (HIV-positive medically confirmed) aged 18 to 60 years attending the above-named health facilities. For the HIV-positive participants, a documented positive HIV result, as well as a history of being followed-up at the HIV treatment and care center. A developed home based exercise programme will be implemented in the experimental group while the control group continues with the usual rehabilitation programme. The primary outcome measures will be function, gait, bone mineral density, physical activity, and QoL.
Discussion:
The proposed trial will compare the effect of a home-based physical exercise-training programme in the management of femoral fracture to the usual physiotherapy management programmes with specific outcomes of bone mineral density, function, and inflammatory markers.
Background
Systematic reviews demonstrated that gait variables are the most reliable predictors of future falls, yet are rarely included in fall screening tools. Thus, most tools have higher specificity than sensitivity, hence may be misleading/detrimental to care. Therefore, this study aimed to determine the validity, and reliability of the velocity field diagram (VFD -a gait analytical tool), and the Timed-up-and-go test (TUG)-commonly used in Nigeria as fall screening tools, compared to a gold standard (known fallers) among community-dwelling older adults.
Method
This is a cross-sectional observational study of 500 older adults (280 fallers and 220 non-fallers), recruited by convenience sampling technique at community health fora on fall prevention. Participants completed a 7-m distance with the number of steps and time it took determined and used to compute the stride length, stride frequency, and velocity, which regression lines formed the VFD. TUG test was simultaneously conducted to discriminate fallers from non-fallers. The cut-off points for falls were: TUG times ≥ 13.5 s; VFD’s intersection point of the stride frequency, and velocity regression lines (E1) ≥ 3.5velots. The receiver operating characteristic (ROC) area under the curves (AUC) was used to explore the ability of the E1 ≥ 3.5velots to discriminate between fallers and non-fallers. The VFD’s and TUG’s sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were determined. Alpha was set at p < 0.05.
Results
The VFD versus TUG sensitivity, specificity, PPV and NPV were 71%, 27%, 55%, and 42%, versus 39%, 59%, 55%, and 43%, respectively. The ROC’s AUC were 0.74(95%CI:0.597,0.882, p = 0.001) for the VFD. The optimal categorizations for discrimination between fallers/non-fallers were ≥ 3.78 versus ≤ 3.78 for VFD (fallers versus non-fallers prevalence is 60.71% versus 95.45%, respectively), with a classification accuracy or prediction rate of 0.76 unlike TUG with AUC = 0.53 (95% CI:0.353,0.700, p = 0.762), and a classification accuracy of 0.68, and optimal characterization of ≥ 12.81 s versus ≤ 12.81 (fallers and non-fallers prevalence = 92.86% versus 36.36%, respectively).
Conclusion
The VFD demonstrated a fair discriminatory power and greater reliability in identifying fallers than the TUG, and therefore, could replace the TUG as a primary tool in screening those at risk of falls.
Background: Upsurge in cardiopulmonary dysfunctions in Enugu, Nigeria, involved mainly cement workers, automobile spray painters, woodworkers, and Cleaners and was worsened in the dry season, suggesting the need for an occupation-specific characterization of the disease features and seasonal evaluation of air quality for prevention and management.
Methods: We conducted a randomized cross-sectional study of eighty consenting participants (in Achara Layout, Enugu), comprising 20 cement workers (39.50 ± 14.95 years), 20 automobile spray painters (40.75 ± 9.85 years), 20 woodworkers (52.20 ± 9.77 years), and 20 cleaners (42.30 ± 9.06 years). The air quality, some haematological (fibrinogen-Fc, and C-reactive protein-CRP), and cardiopulmonary parameters were measured and analyzed using ANCOVA, at p < 0.05.
Results: The dry season particulate matter (PM) in ambient air exceeded the WHO standards in the New layout [PM10 = 541.17 ± 258.72 µg/m3; PM2.5 = 72.92 ± 25.81 µg/m3] and the University campus [PM10 = 244 ± 74.79 µg/m3; PM2.5 = 30.33 ± 16.10 µg/m3], but the former was twice higher. The PM differed significantly (p < 0.05) across the sites. Forced expiratory volume at the first second (FEV1) (F = 6.128; p = 0.001), and Peak expiratory flow rate (PEFR) (F = 5.523; p = 0.002), differed significantly across the groups. FEV1/FVC% was < 70% in cement workers (55.33%) and woodworkers (61.79%), unlike, automobile spray painters (72.22%) and cleaners (70.66%). FEV1 and work duration were significantly and negatively related in cement workers (r = -0.46; r2 = 0.2116; p = 0.041 one-tailed). CRP (normal range ≤ 3.0 mg/L) and Fc (normal range—1.5–3.0 g/L) varied in cement workers (3.32 ± 0.93 mg/L versus 3.01 ± 0.85 g/L), automobile spray painters (2.90 ± 1.19 mg/L versus 2.54 ± 0.99 mg/L), woodworkers (2.79 ± 1.10 mg/L versus 2.37 ± 0.92 g/L) and cleaners (3.06 ± 0.82 mg/L versus 2.54 ± 0.70 g/L).
Conclusion(s): Poor air quality was evident at the study sites, especially in the dry season. Cement workers and automobile spray painters showed significant risks of obstructive pulmonary diseases while woodworkers had restrictive lung diseases. Cement workers and cleaners recorded the highest risk of coronary heart disease (CRP ≥ 3.0 mg/L). The similarity in Fc and CRP trends suggests a role for the inflammation-sensitive proteins in the determination of cardiovascular risk in cement workers and cleaners. Therefore, there are occupation-specific disease endpoints of public health concern that likewise warrant specific preventive and management approaches among the workers.