Current Issue Volume 8 | Issue 3 | TEXILA INTERNATIONAL JOURNAL OF MEDICINE

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October 2025

Volume 8 | Issue 3

ISSUE DOI: 10.21522/TIJMD.2013.08.03

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Recent articles

Determinants of Antenatal Exercise among Pregnant Women Attending Antenatal Clinic in Owo, Ondo State

Author: Umar N. Jibril

DOI: 10.21522/TIJMD.2013.08.03.Art001

[ABSTRACT] [Full-Text PDF] [REFERENCES]

Determinants of Antenatal Exercise among Pregnant Women Attending Antenatal Clinic in Owo, Ondo State

Abstract:

Despite proven benefits of Regular physical exercise in all phases of life, especially in pregnancy, pregnant women are not seen demonstrating good practice of antenatal exercises at various health centers in Owo. This study aimed to examine the determinants of Antenatal Exercise among Pregnant women in Ondo State. A cross-sectional survey was conducted among 172 pregnant women attending antenatal clinics at FMC Owo. A researcher-structured questionnaire consisted of four sections (A-D) based on the study objectives was administered on pregnant women assisted by trained nurses on each clinic day. Data was analyzed using SPSS version 25.0 and results was presented on frequency /percentage tables, and ANOVA was used to test hypotheses at 95% CI. Most women were in their active reproductive age (28.5 years ±4.02SD), their knowledge, and practice of antenatal exercise were fairly good but most did not follow recommended guidelines by American College of Obstetricians and Gynecologists guidelines. Common factors that determined practice of antenatal exercise are number of deliveries (62%), place of residence (54.7%), Health status (70.4%) and economic status (64.0%). This study concluded that there was no significant relationship between knowledge and practices (1.32), but significant relationship exists between occupation (4.43), parity (3.92) and practice of antenatal exercise respectively. Women antenatal exercise practice is still a challenge as it does not meet the recommended guidelines by the American College of Obstetricians and Gynecologists. However, it is recommended that health education on the importance of regular practice of antenatal exercise should be emphasized.

Determinants of Antenatal Exercise among Pregnant Women Attending Antenatal Clinic in Owo, Ondo State

References:

[1]. Okedo-Alex, I. N., Akamike, I. C., Ezeanosike, O. B., & Uneke, C. J., 2019, Determinants of antenatal care utilization in sub-Saharan Africa: a systematic review. BMJ open. 9(10); e031890. Available at https://doi.org/10.1136/bmjopen-2019-031890

[2]. WHO., 2024, Recommendations on antenatal care for a positive pregnancy experience; 2016. Available at: https://www.who. int/publications/i/item/9789241549912. retrieved on 12^th March.

[3]. Garland, M., 2017, Physical activity during pregnancy: a prescription for improved perinatal outcomes. The Journal for Nurse Practitioners; 13(1), 54–8.

[4]. ACOG., 2021, Physical Activity and Exercise During Pregnancy and the Postpartum Period; Retrieved 30^th July, 2024 from: https://www.acog.org/en/Clinical/ClinicalGuidance/CommitteeOpinion/Articles/2020/04/PhysicalActivityandExerciseDuringPregnancyandthePostpartumPeriod.

[5]. Janakiraman, B., Gebreyesus, T., Yihunie, M., & Genet, M. G., 2021, Knowledge, attitude, and practice of antenatal exercises among pregnant women in Ethiopia: A cross-sectional study. PloS one, 16(2); e0247533. access from https://doi.org/10.1371/journal.pone.0247533KAP.

[6]. Sageer, R., Kongnyuy, E., Adebimpe, W. O., Omosehin, O., Ogunsola, E. A., & Sanni, B., 2019, Causes and contributory factors of maternal mortality: evidence from maternal and perinatal death surveillance and response in Ogun state, Southwest Nigeria. BMC Pregnancy and Childbirth 19:63. Available at https://doi.org/10.1186/s12884-019-2202-1

[7]. Ope, B. W., 2020, Reducing maternal mortality in Nigeria: addressing maternal health services’ perception and experience. Journal of Global Health Reports (4), e2020028. doi:10.29392/001c.12733.

[8]. Hashmi, M., Ain, Q. U., Shaikh, N. U. S., & Valecha, J., 2020, Knowledge and Attitude of Pregnant Women Regarding Antenatal Exercises. Journal of Pharmaceutical Research International, 32(23), 146-151. Available at https://doi.org/10. 9734/jpri/ 2020/v32 i2330801

[9]. Barakat, R., Pelaez, M., Cordero, Y., Perales, M., Lopez, C., Coteron, J., et al., 2016, Exercise during pregnancy protects against hypertension and macrosomia: Randomized clinical trial. Am JObstetrGynecol; 214(649), e1-8.

[10]. Ojukwu, C. P., Okemuo, A. J., Okeke, O., Anekwu, E., & Uchenwoke, C., 2018, Postpartum health-related quality of life: Relationship to antenatal exercise practice in a Nigerian population. Int J Reprod Contracept Obstet Gynecol; 7(7), 2541–6.

[11]. Opiah, M. M., Oyira, E. J., & Osaji, T. A., 2019, Perceived Benefits of Exercise Among Pregnant womenIn University of Calabar Teaching Hospital, Calabar, Cross River State. Journal of Health and Psychology Research; 7(3), 22-41,

[12]. Mbada, C. E., Orji, O. E., Iyiola, A. M., Adeyemi, A. B., Afolabi, E. K., & Petronilla, O. C., 2019, Relationship between physical activity and fatigue among Nigerian pregnant women. Women Health Bull 6(1), e61339

[13]. Azura, I. N., Azlina. I., Rosnami, Z., & Norhayati, M. N., 2020, Effectiveness of an Antenatal Exercise Counselling Module on Knowledge and Self-efficacy of Nurses in Northeast Peninsular Malaysia: A Quasi-Experimental Study. Malaysia J Med Sci; 27(3), 84-92.

[14]. Kolomanska-Boguck, D., & Mazur-Bialy, A. L., 2019, Physical Activity and the Occurrence of Postnatal Depression-A Systematic Review. Medicina (Kaunas, lithuania); 55(9), 560. http://doi.org/10.3390/medicina55090560

[15]. Nakamura, A., Waerden, J., Melchior, M., Bolze, C., El- Khoury, F., & Pryor, L., 2019, Physical activity during pregnancy and postpartum depression: systematic review and meta-analysis. J Affect Disord; 246:29–41

[16]. Gebregziabher, D., Berhe, H., Kassa, M., & Berhanie, E., 2019, Level of physical activity and associated factors during pregnancy among women who gave birth in Public Zonal Hospitals of Tigray. BMC research notes; 12(1), 454. 10.1186/s13104-019-4496-5

[17]. Yin, Y., Huang, Y., Liu, X., & Luo, B., 2019, Assessment of physical activity status among pregnant women in southwestern China. Frontiers of Nursing; 6(4), 135–41.

[18]. U.S., 2018, Department of Health and Human Services. Physical activity guidelines for Americans. 2nd ed. Washington, DC: DHHS. Available at: https://health.gov/paguidelines/.

[19]. Hailemariam, T. T., Gebregiorgis, Y. S., Gebremeskel, B. F., Haile, T. G., & Spitznagle, T. M., 2020, Physical activity and associated factors among pregnant women in Ethiopia: facility-based cross-sectional study. BMC Pregnancy and Childbirth; 20(1), 92. https://doi.org/10.1186/s12884-020-2777-6

[20]. Muche, A. A., Olayemi, O. O., & Gete, Y. K., 2019, Prevalence of gestational diabetes mellitus and associated factors among women attending antenatal care at Gondar town public health facilities, Northwest Ethiopia. BMC pregnancy and childbirth;19(1) :334 10.1186/s12884-019-2492-3

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11	1

Challenges Associated with Public-Private Partnerships in the Provision of Maternal Healthcare Services at General Hospitals in Abuja, FCT, Nigeria

Author: Sunday AGAMAH

DOI: 10.21522/TIJMD.2013.08.03.Art002

[ABSTRACT] [Full-Text PDF] [REFERENCES]

Challenges Associated with Public-Private Partnerships in the Provision of Maternal Healthcare Services at General Hospitals in Abuja, FCT, Nigeria

Abstract:

Most Sub-Saharan African public health facilities struggle to provide high-quality healthcare services due to multifaceted factors. Public-Private Partnerships (PPPs) pool resources, combines the strengths of public and private sector, and can deliver superior health services. PPPs in health have achieved successes in malaria control and polio eradication and the lessons learned are applicable to maternal healthcare services. However, PPPs can encounter several challenges, including infrastructure, technology, economic, financial, social acceptance, legal, political, and manpower challenges. This study assessed the perceived challenges of PPPs in health among maternal healthcare managers at one privately managed General Hospital and three publicly managed General Hospitals in Abuja, Nigeria. Using a qualitative study design, key informant interviews were conducted with maternal healthcare managers at Garki, Nyanya, Karshi and Asokoro General Hospitals. Thematic analysis revealed challenges unique to PPP in health, with themes such as low awareness about PPP concept by providers, pro-rich orientation and higher costs of care, inconsistent legal and political supportive framework by government, lower staff remuneration, fewer staff development opportunities, sub-optimal data exchange with National Health Management Information System. Additional themes described challenges affecting publicly and privately managed General hospitals such as high energy costs, limited bed spaces and inadequate manpower. Other themes also emerged about benefits of PPP notably improved efficiency, accountability and quality of care, as well as provision of a tiered pricing mechanism for all client type. This study recommends full implementation of PPP policy by all partners, as well as creating more awareness about PPP in health.

Challenges Associated with Public-Private Partnerships in the Provision of Maternal Healthcare Services at General Hospitals in Abuja, FCT, Nigeria

References:

[1]. Wilmoth, J. R., Mizoguchi, N., Oestergaard, M. Z., Say, L., Mathers, C. D., Zureick-Brown, S., Inoue, M., Chou, D., 2012, A New Method for Deriving Global Estimates of Maternal Mortality. Statistics, Politics, and Policy, 3(2), 1.

[2]. Charles, C. E., Ogochukwu, R. E., Chukwunonso, S. E., 2024, Public-Private Partnerships In Health Sector Innovation: Lessons From Around The World. imsrj, 4(4), 484–499.

[3]. Rawlings, C., Adekunle, O. A., Chioma, A. O., Oloruntoba, B., Jeremiah, O. A., 2024, Psychological Resilience in Healthcare Workers: A Review of Strategies and Intervention. World J. Bio. Pharm. Health Sci., 17(2), 387–395.

[4]. Babatunde, S. O., Ekundayo, D., Udeaja, C., Abubakar, U. O., 2022, An investigation into the sustainability practices in PPP infrastructure projects: A case of Nigeria. Smart and Sustainable Built Environment, 11(1), 110–125.

[5]. Salangwa, C., Munthali, R., Mfune, L., Nyirenda, V. K., 2025, Public-Private Partnership (PPP) and Health Service Delivery in Malawi: The Case of Christian Health Association of Malawi (CHAM) Facilities in Mzimba District. Health Policy OPEN, 8: 100139.

[6]. Basu, S., Andrews, J., Kishore, S., Panjabi, R., Stuckler, D., 2012, Comparative Performance of Private and Public Healthcare Systems in Low- and Middle-Income Countries: A Systematic Review. PLoS Med, 9(6), e1001244.

[7]. Whyle, E. B., Olivier, J., 2016, Models of Public–Private Engagement for Health Services Delivery and Financing in Southern Africa: A Systematic Review. Health Policy Plan., 31(10), 1515–1529.

[8]. Batjargal, T., Zhang, M., 2021, Review of Key Challenges in Public-Private Partnership Implementation, J Infrastruct Policy Dev, 5(2), 1378.

[9]. Herman, N. G., Rosenberg, L. R., Moursi, A. M., 2008, Public-private collaboration to improve oral health status of children enrolled in head start in New York City, N Y State Dent J, 74(4), 32.

[10]. Ravindran, T. K. S., 2011, Public-Private Partnerships in Maternal Health Services. Economic and Political Weekly, 46(48), 43–52.

[11]. McKee, M., Edwards, N., Atun, R., et al., 2006, Public–private partnerships for hospitals. Bull World Health Organ, 84:890–6. Cited by Hellowell, M., 2019, Are Public–Private Partnerships the Future of Healthcare Delivery in Sub-Saharan Africa? Lessons from Lesotho. BMJ Glob Health, 4(2), e001217.

[12]. Anyaehie, U., Nwakoby, B., Chikwendu, C., Dim, C., Uguru, N., Oluka, C., Ogugua, C., 2014, Constraints, Challenges and Prospects of Public-Private Partnership in Healthcare Delivery in a Developing Economy. Ann Med Health Sci Res, 4(1), 61.

[13]. Basabih, M., Prasojo, E., Rahayu, A. Y. S., 2022, Hospital Services Under Public-Private Partnerships, Outcomes and Challenges: A literature Review. Journal of Public Health Research, 11(3), 1.

[14]. Sekhri, N., Feachem, R., Ni, A., 2011, Public-Private Integrated Partnerships Demonstrate the Potential to Improve Health Care Access, Quality, And Efficiency. Health Affairs, 30(8), 1498–1507.

[15]. Okafor, C., 2016, Improving Outcomes in the Nigeria Healthcare Sector Through Public- Private Partnership. Afr. Res. Rev., 10(4), 1.

[16]. Van den Heever, A., 2017, Developing Coordinated Public-Private Partnerships and Systems for Financing Health in Africa: Experiences from Africa and India. 2017. WITS-AfDB Publication

[17]. Nigeria, 2006, National Policy on Public-Private Partnership for Health in Nigeria. Abuja [Nigeria], Federal Ministry of Health, 2006.

[18]. Mugo, M. G., 2023, The Impact of Health Insurance Enrollment on Health Outcomes in Kenya. Health Economics Review, 13(1), 42.

[19]. Erlangga, D., Suhrcke, M., Ali, S., Bloor, K., 2019, The Impact of Public Health Insurance on Healthcare Utilization, Financial Protection and Health Status in Low- and Middle-Income Countries: A Systematic Review. PLoS ONE, 14(8), e0219731.

[20]. Ferreira, D. C., Marques, R. C., 2021, Public-Private Partnerships in Health Care Services: Do they Outperform Public Hospitals Regarding Quality and Access? Evidence from Portugal. Socio-Economic Planning Sciences, 73, 100798.

[21]. Public Private Partnership in the Health Sector: Practical Issues for Consideration. World Bank. Accessed: Jun. 09, 2025. [Online]. Available: https://documents.worldbank.org/en/publication/documents-reports/documentdetail/en/526271561755472041.

[22]. Nuhu, S., Mpambije, C. J., Ngussa, K., 2020, Challenges in Health Service Delivery under Public-Private Partnership in Tanzania: Stakeholders’ Views from Dar es Salaam Region. BMC Health Serv Res, 21(1), 765.

[23]. Asasira, J., Ahimbisibwe, F., 2018, Public-Private Partnership in Health Care and Its Impact on Health Outcomes: Evidence from Ruharo Mission Hospital in Uganda. IJSSS, 6(12), 79.

[24]. Nwafor, N. F., Okoye, U. O., 2024, Perceived Inadequate Welfare of Healthcare Professionals in Nigeria and its Influence on Service Delivery and Patients’ Safety. jswds, 6(2), 13–29.

[25]. Bello, S., Oni, T. E., Salawu, M. M., 2021, Job Satisfaction and Psychological Health Among Health Workers in Lagos State Teaching Hospital, Nigeria. Ann Ib Postgrad Med, 19(2), 147–155.

[26]. Gbala, O., Adeniyi, O. O., Olaoye, O., Oke, O. F., Bakare, B., et al., 2024, The Impact of High Electricity Tariffs on the Tertiary Healthcare System in Nigeria: A Critical Review. Int. J. Res. Manage., 6(2), 423–428.

[27]. Eze, O. I., Iseolorunkanmi, A., Adeloye, D., 2024, The National Health Insurance Scheme (NHIS) in Nigeria: Current Issues and Implementation Challenges. Journal of Global Health Economics and Policy, 4.

[28]. Okafor, I. J., 2020, Health Infrastructure and Implementation Of Health Policy In Nigeria: A Case of NHIS In FCT, Abuja. International Journal of Management, Social Sciences, Peace and Conflict Studies, 3(4).

[29]. Omoleke, I. I., Taleat, B. A., 2018, Contemporary Issues and Challenges of Health Sector in Nigeria. Research Journal of Health Sciences, 5(4), 210.

[30]. Rosser, J. I., Aluri, K. Z., Kempinsky, A., Richardson, S., Bendavid, E., 2022, The Effect of Healthcare Worker Density on Maternal Health Service Utilization in Sub-Saharan Africa. The American Journal of Tropical Medicine and Hygiene, 106(3), 939-944.

[31]. Ogundeji, Y. K., Omoleke, S. A., 2015, PPP and the Development of Healthcare Infrastructure: A Review. Journal of Applied Sciences and Environmental Management, 19(3), 469-474.

[32]. Uplekar M., 2016, Public-Private Mix for Tuberculosis Care and Prevention. What Progress? What Prospects? Int J Tuberculosis Lung Disease, 20(11),1424–9.

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Stakeholder Perspectives on Enhancing Vaccine Manufacturing in Nigeria: A Quantitative Assessment of Influencing Factors

Author: Longe Sunday Anthony

DOI: 10.21522/TIJMD.2013.08.03.Art003

[ABSTRACT] [Full-Text PDF] [REFERENCES]

Stakeholder Perspectives on Enhancing Vaccine Manufacturing in Nigeria: A Quantitative Assessment of Influencing Factors

Abstract:

Nigeria has long experienced vaccine supply disruptions due to limited resources, inadequate infrastructure, and high dependence on imports—factors that have stalled the growth of local vaccine manufacturing. Achieving vaccine self-sufficiency and strengthening public health infrastructure require strategic investments, particularly in technology transfer. This study explores challenges and opportunities for enhancing vaccine production in Nigeria and provides recommendations for effective implementation. A descriptive cross-sectional survey was conducted using a structured questionnaire administered to 111 purposively selected stakeholders, representatives from academia, regulatory agencies, research institutions, development partners, and private industry. The questionnaire assessed six domains: regulatory environment, infrastructure, technical capacity, finance, human resources, and market dynamics. Data were analyzed using IBM SPSS version 25 with descriptive statistics and Spearman rank correlation. Out of the 111 participants, 57 responded to the question on key interventions to promote vaccine manufacturing. Among them, 68% identified technology-sharing with international manufacturers, government subsidies and tax incentives, and workforce development as top strategies. (Spearman’s rank) Strong positive correlations were found between local vaccine production capacity and regulatory support (ρ = 0.811, p < 0.01), infrastructure (ρ = 0.823, p < 0.01), access to finance (ρ = 0.844, p < 0.01), and market sustainability (ρ = 0.839, p < 0.01). Technical capacity (ρ = 0.693) and human resources (ρ = 0.637) showed moderate correlations. These findings highlight the multifaceted nature of barriers and enablers. Collaborative efforts among government, private sector, and international partners are essential to build sustainable, equitable vaccine manufacturing in Nigeria.

Stakeholder Perspectives on Enhancing Vaccine Manufacturing in Nigeria: A Quantitative Assessment of Influencing Factors

References:

[1]. Uzochukwu, B. S. C., et al., 2015, "Policy Barriers and Opportunities for Vaccine Production in Nigeria." Journal of Public Health Policy, 36(4), 471-487.

[2]. Nkengasong, J., Ndembi, N., & Moeti, M. 2021, Vaccine Manufacturing in Africa: Addressing the Barriers. The Lancet Global Health, 9(6), e758-e763.

[3]. Addressing the Barriers. The Lancet Global Health, 9(6), e758-e763.

[4]. AFDB (African Development Bank), 2023, Strengthening Africa’s Pharmaceutical and Vaccine Manufacturing Capacity. Retrieved from www.afdb.org

[5]. WHO (World Health Organization), 2021, The mRNA Vaccine Technology Transfer Hub. Retrieved from www.who.int

[6]. Clift, C., 2020, Understanding Technology Transfer in the Vaccine Industry. Vaccine Insights, 11(3), 301-317.

[7]. GAVI (Global Alliance for Vaccines and Immunization), 2023, Vaccine Supply Chain and Manufacturing Strategies. Retrieved from www.gavi.org

[8]. Kraus, M., Smith, D., & Alhassan, T., 2020, Evaluating Technology Transfer in African Vaccine Manufacturing. Journal of Global Health Policy, 32(2), 112-129.

[9]. AfDB (African Development Bank), 2023, Strengthening Africa’s Pharmaceutical and Vaccine Manufacturing Capacity. Retrieved from www.afdb.org

[10]. Okereke, E., & Ekeke, P., 2021, Policy Frameworks for Sustainable Vaccine Manufacturing in Nigeria. Journal of African Health Economics, 27(1), 45-62.

[11]. Chakraborty, T., & Singh, R., 2020, The Role of Technology Transfer in Vaccine Production: Lessons from India. International Journal of Vaccine Research, 18(4), 189-203.

[12]. World Health Organization (WHO), 2021, Local production and technology transfer to increase access to COVID-19 vaccines: Policy brief. https://www.who.int/publications/i/item/WHO-UHL-PHC-SPP-2021.01

[13]. Narayan, V., & Campbell, S., 2019, Healthcare Investments in Emerging Markets: The Role of Collaborative Agreements. Healthcare Finance Journal, 24(2), 195-210.

[14]. World Health Organization, 2021, Global Vaccine Manufacturing and Regulatory Frameworks. WHO Press.

[15]. Marston, N., & Morgan, G., 2020, "Capacity Constraints in Developing Countries' Health Sectors: A Study on Vaccine Production." Development Journal, 30(1), 113-130.

[16]. Rogers, E. M., 2003, Diffusion of Innovations (5th ed.). Free Press.

[17]. Kraus, M., Smith, D., & Alhassan, T., 2020, Evaluating Technology Transfer in African Vaccine Manufacturing. Journal of Global Health Policy, 32(2), 112-129.

[18]. Gavi, the Vaccine Alliance. 2022, Sustainable vaccine manufacturing in Africa: Gavi’s position paper. https://www.gavi.org

[19]. World Health Organization (WHO), 2023, Global Vaccine Market Report: Nigeria’s Standing in Local Production. WHO Publications.

[20]. Nigerian Ministry of Health, 2022, Policy Review on Nigeria’s Vaccine Production Capacity. Federal Ministry of Health Report.

[21]. GAVI, 2023, Nigeria Vaccine Investment Strategy: Funding and Developmental Progress. GAVI Reports on Vaccine Sustainability.

[22]. Chakrabarti, A., Banerjee, S., & Dey, S., 2022, "Growth of the Indian Vaccine Industry: Government Support and Market Expansion." Journal of Vaccine Research and Development, 15(2), 89-105.

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10	1

Scoping Review on the Quality of Life of the Visually Impaired

Author: Timothy Olatunji OLADOSU

DOI: 10.21522/TIJMD.2013.08.03.Art004

[ABSTRACT] [Full-Text PDF] [REFERENCES]

Scoping Review on the Quality of Life of the Visually Impaired

Abstract:

This scoping review systematically examined the relationship between visual impairment (VI) and quality of life (QoL), with particular emphasis on the social, psychological, and functional domains most affected. It also aimed to identify existing QoL assessment tools and evaluate their conceptual frameworks, multidimensionality, and contextual relevance. A comprehensive literature search was conducted in March 2025 across six electronic databases: EMBASE, PubMed, CINAHL, MEDLINE, the Cochrane Library, and Airiti Library. Following rigorous screening procedures, 62 peer-reviewed English-language studies were included. The review analyzed both theoretical perspectives and empirical evidence, as well as measurement instruments used to assess QoL among individuals with VI. Findings revealed that VI significantly impacts multiple aspects of QoL, including physical functioning, psychological well-being, social participation, and economic stability. While 29 vision-specific QoL instruments were identified, most focused narrowly on functional limitations and visual ability, with limited attention to environmental, emotional, and social factors. Only a few tools addressed broader contextual elements such as autonomy, dignity, and quality of social engagement. Age, severity of vision loss, socioeconomic status, and access to care were key determinants influencing QoL outcomes. Overall, VI presents far-reaching challenges that extend beyond sight loss, affecting autonomy, mental health, and social inclusion. Existing assessment tools often fail to capture the full lived experience of individuals with VI, particularly in low- and middle-income countries. There is a critical need for more holistic, culturally responsive, and multidimensional approaches to QoL assessment.

Scoping Review on the Quality of Life of the Visually Impaired

References:

[1]. World Health Organization., 2019, World report on vision. https://www.who.int/publications-detail/world-report-on-vision

[2]. Jackson, M. L., Burr, J., & Fielder, A., 2020, Vision, independence and aging: A review of global challenges. Journal of Vision Health, 12(3), 198–210.

[3]. Bitner, R., Chang, L., & Hart, S., 2023, Understanding visual impairment: Causes, classifications, and rehabilitation. Journal of Ophthalmic Research, 45(2), 112–124.

[4]. Pascolini, D., & Mariotti, S. P., 2012, Global estimates of visual impairment: 2010. British Journal of Ophthalmology, 96(5), 614–618. https://doi.org/10.1136/bjophthalmol-2011-300539

[5]. Bourne, R. R. A., Flaxman, S. R., Braithwaite, T., Cicinelli, M. V., Das, A., Jonas, J. B., ... & Resnikoff, S., 2021, Magnitude, temporal trends, and projections of the global burden of uncorrected presbyopia: A systematic review and meta-analysis. The Lancet Global Health, 9(2), e160-e168. https://doi.org/10.1016/S2214-109X(20)30313-2

[6]. Resnikoff, S., Lansingh, V. C., Washburn, L., Felch, W. C., Gauthier, T. M., & Taylor, H. R., 2020, Estimated number of ophthalmologists worldwide (International Council of Ophthalmology update): Will we meet the needs? British Journal of Ophthalmology, 104(4), 588–592. https://doi.org/10.1136/bjophthalmol-2019-314336

[7]. Lamoureux, E. L., Hassell, J. B., & Keeffe, J. E., 2009, The determinants of participation in activities of daily living in people with impaired vision. American Journal of Ophthalmology, 147(2), 266–273.e1. https://doi.org/10.1016/j.ajo.2008.08.014

[8]. Tanui, D., 2015, Disability and exclusion: Experiences of people with visual impairments in Kenya. African Journal of Disability, 4(1), 1–8. https://doi.org/10.4102/ajod.v4i1.161

[9]. Nshimiyimana, A., Kalisa, R., & Musabyimana, A., 2022, Barriers to inclusive eye care services in sub-Saharan Africa. African Vision and Health Journal, 6(1), 35–44.

[10]. Finger, R. P., Fenwick, E., Marella, M., & Lamoureux, E. L., 2011, The impact of vision impairment on vision-specific quality of life in Germany. Investigative Ophthalmology & Visual Science, 52(6), 3613–3619. https://doi.org/10.1167/iovs.10-6665

[11]. Gaspar, T., Ferreira, M., Marques, A., Leal, I., & Paiva, T., 2017, Health-related quality of life in children and adolescents: Perceptions of parents and children. Journal of Pediatric Psychology, 42(2), 162–171. https://doi.org/10.1093/jpepsy/jsw060

[12]. Inkeles, A., 2022, Defining quality of life across cultures. Social Indicators Research, 160(1), 5–22.

[13]. World Health Organization., 1997, WHOQOL: Measuring quality of life. https://www.who.int/tools/whoqol

[14]. Jones, L., Mohandas, T., & Tadi, P., 2019, Visual impairment and its impact on mental health. Community Eye Health Journal, 32(105), 26–30.

[15]. Rees, G., Fenwick, E. K., & Keeffe, J. E., 2010, Impact of age-related macular degeneration on quality of life. British Journal of Ophthalmology, 94(5), 632–636. https://doi.org/10.1136/bjo.2009.164970

[16]. Evans, J. R., Fletcher, A. E., & Wormald, R. P. L., 2007, Depression and anxiety in visually impaired older people. Ophthalmology, 114(2), 283–288. https://doi.org/10.1016/j.ophtha.2006.10.006

[17]. Yeshanew, B., Abebe, S., & Teshome, D., 2023, Psychosocial outcomes among people with visual impairment in Ethiopia. East African Journal of Health and Social Sciences, 5(2), 115–123.

[18]. Alma, M. A., Van der Mei, S. F., Melis-Dankers, B. J. M., Van Tilburg, T. G., Groothoff, J. W., & Suurmeijer, T. P. B. M., 2011, Participation of the elderly after vision loss. Disability and Rehabilitation, 33(1), 63–72. https://doi.org/10.3109/09638288.2010.488708

[19]. Riazi, A., Rowe, F. J., & Peat, N., 2020, The impact of visual impairment on psychosocial outcomes in adults: A systematic review. Health & Social Care in the Community, 28(6), 2020–2034. https://doi.org/10.1111/hsc.13013

[20]. Kuper, H., Polack, S., & Eusebio, C., 2008, A review of the literature on barriers to the uptake of eye care services in developing countries. Ophthalmic Epidemiology, 15(2), 73–82. https://doi.org/10.1080/09286580701877840

[21]. Gupta, J., & Vegelin, C., 2016, Sustainable development goals and inclusive development. International Environmental Agreements: Politics, Law and Economics, 16(3), 433–448. https://doi.org/10.1007/s10784-016-9323-z

[22]. Reddy, S., 2016, Inclusion of disability in global development: SDGs and beyond. International Journal of Disability Studies, 10(1), 7–14.

[23]. International Agency for the Prevention of Blindness (IAPB)., 2022, 2030 in sight: Strategy for ending avoidable sight loss. https://www.iapb.org

[24]. Khadka, J., McAlinden, C., & Pesudovs, K., 2010, Quality assessment of vision-related quality of life questionnaires. Optometry and Vision Science, 87(12), 1029–1040. https://doi.org/10.1097/OPX.0b013e3181f1f39d

[25]. Mangione, C. M., Lee, P. P., Pitts, J., Gutierrez, P., Berry, S., & Hays, R. D., 2001, Development of the 25-item National Eye Institute Visual Function Questionnaire. Archives of Ophthalmology, 119(7), 1050–1058. https://doi.org/10.1001/archopht.119.7.1050

[26]. Post M. W., 2014, Definitions of quality of life: what has happened and how to move on. Topics in spinal cord injury rehabilitation, 20(3), 167–180. https://doi.org/10.1310/sci2003-167

[27]. Barry, R. J., De Kock, T. P., Mathews, D. E., & Lingham, G., 2017, Limitations of vision‑specific quality‑of‑life instruments. Clinical Vision Journal, 12(3), 145–152.

[28]. Béchetoille, A., Arnould, B., Bron, A., Baudouin, C., Renard, J.-P., Sellem, E., … Rouland, J.-F., 2008, Measurement of health-related quality of life with glaucoma: Validation of the Glau‑QoL 36‑item questionnaire. Acta Ophthalmologica, 86(1), 71–80. https://doi.org/10.1111/j.1600-0420.2007.00999.x

[29]. Hays R. D., Hahn H., & Marshall G., 2002, Use of the SF‑36 and other health‑related quality of life measures to assess persons with disabilities. Archives of Physical Medicine and Rehabilitation, 83(S4), S4–S9.

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[31]. Lee, B. L., Suh, W., Kim, T. H., Park, J. W., Kim, J. H., & Kim, D. J., 2005, Assessing quality of life in individuals with visual impairment. Health and Quality of Life Outcomes, 3, 21.

[32]. Pesudovs, K., Garamendi, E., & Elliott, D. B., 2006, A quality of life comparison of people wearing spectacles, contact lenses, or having undergone refractive surgery. Journal of Refractive Surgery, 22(1), 19–27. https://doi.org/10.3928/1081-597X-20060101-07

[33]. Margolis, M. K., Coyne, K., Kennedy‑Martin, T., Baker, T., Schein, O., & Revicki, D. A., 2002, Vision-specific instruments for the assessment of health-related quality of life and visual functioning: A literature review. Pharmacoeconomics, 20(12), 791–812. https://doi.org/10.2165/00019053‑200220120‑00001

[34]. Terwee, C. B., Bot, S. D. M., de Boer, M. R., van der Windt, D. A. W. M., Knol, D. L., Dekker, J., Bouter, L. M., & de Vet, H. C. W., 2007, Quality criteria were proposed for measurement properties of health status questionnaires. Journal of Clinical Epidemiology, 60(1), 34–42. https://doi.org/10.1016/j.jclinepi.2006.03.012

[35]. Marans, R. W., 2003, Understanding environmental quality through quality of life studies: the 2001 DAS and its use of subjective and objective indicators. Journal of Landscape and Urban Planning, 65(1–2), 73–83.

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[37]. Frost, M. H., Reeve, B. B., Liepa, A. M., Stauffer, J. W., & Hays, R. D., 2007, What is sufficient evidence for the reliability and validity of patient-reported outcome measures? Value in Health, 10(Suppl 2), S94–S105.

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[39]. Vu, H. T., Keeffe, J. E., McCarty, C. A., & Taylor, H. R., 2005, Impact of unilateral and bilateral vision loss on quality of life. The British journal of ophthalmology, 89(3), 360–363. https://doi.org/10.1136/bjo.2004.047498

[40]. Chia, E. M., Wang, J. J., Rochtchina, E., Smith, W., Cumming, R. R., & Mitchell, P., 2004, Impact of bilateral visual impairment on health-related quality of life: The Blue Mountains Eye Study. Investigative Ophthalmology & Visual Science, 45(1), 71–76. https://doi.org/10.1167/iovs.03-0661

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Awareness of the Importance of COVID-19 Vaccination in Wenchi Municipality: A Health Belief Model Perspective

Author: Stephen Nyarko-Ameyaw

DOI: 10.21522/TIJMD.2013.08.03.Art005

[ABSTRACT] [Full-Text PDF] [REFERENCES]

Awareness of the Importance of COVID-19 Vaccination in Wenchi Municipality: A Health Belief Model Perspective

Abstract:

The COVID-19 pandemic, caused by the novel coronavirus (SARS-CoV-2), has had unprecedented health, and economic impacts globally. Vaccination emerged as a cornerstone strategy for reducing morbidity, mortality, and transmission of the virus. However, in many low- and middle-income countries (LMICs), uptake has been suboptimal despite extensive awareness campaigns. In Wenchi Municipality, fully vaccinated coverage stood at 25.3% in July 2024; far below the WHO-recommended herd immunity threshold of 70%. This study examines awareness of the importance of COVID-19 vaccination, using Health Belief Model (HBM) to interpret findings and guide recommendations. A convergent mixed-method cross-sectional design was employed, targeting 288 adults aged 18 years and above, selected through probability proportional to size (PPS) sampling. Quantitative data were collected using a structured questionnaire and analyzed using descriptive and inferential statistics. Qualitative responses were obtained using open-ended questions and were analyzed through thematic analysis. While 82.7% of respondents believed vaccination could prevent COVID-19, gaps remained in understanding broader benefits such as reduction in severity, community protection, and facilitation of safe travel. About 17% perceived vaccination as a threat to life and 11.5% denied its preventive value. The study found that awareness was high in terms of perceived benefits but inconsistent in linking perceived susceptibility and cues to action. Safety concerns, misinformation, and distrust in vaccine efficacy were key barriers. Awareness alone is insufficient for vaccine uptake. Public health strategies must combine information dissemination with interventions that directly target barriers and strengthen cues to action, ultimately transforming knowledge into vaccination behavior.

Awareness of the Importance of COVID-19 Vaccination in Wenchi Municipality: A Health Belief Model Perspective

References:

[1]. World Health Organization (WHO), 2024, WHO coronavirus (COVID-19) dashboard. Retrieved from https://covid19.who.int

[2]. Dhama, K., et al., 2020, COVID-19, an emerging coronavirus infection: Advances and prospects in designing and developing vaccines, immunotherapeutics, and therapeutics. Human Vaccines & Immunotherapeutics, 16(6), 1232–1238.

[3]. Apanga, P. A., et al., 2020, COVID-19 in Ghana: A call for urgent public health interventions. Journal of Public Health in Africa, 11(2), 180–184.

[4]. Soeters, H. M., et al., 2022, Herd immunity and COVID-19 vaccination: Global targets and challenges. The Lancet Infectious Diseases, 22(6), e174–e183.

[5]. Kwon, H., & Rahmati, M., 2022, Global disparities in COVID-19 vaccine access. The Lancet Global Health, 10(5), e728–e729.

[6]. Ghana Health Service (GHS), 2023, Annual COVID-19 Vaccination Coverage Report. Accra: GHS.

[7]. Effiong, A., et al., 2023, COVID-19 vaccine awareness and hesitancy among Nigerian undergraduate students. Journal of Community Health, 48(4), 827–838.

[8]. Kreps S. E., Kriner D. L., 2021, Factors influencing Covid-19 vaccine acceptance across subgroups in the United States: Evidence from a conjoint experiment. Vaccine, 39:3250–8. https://doi.org/10.1016/j.vaccine.2021.04.044

[9]. Adiyoso, W., et al., 2023, Health Belief Model and COVID-19 vaccine hesitancy: A cross-sectional study. Journal of Public Health Research, 12(3), 245–257.

[10]. Khairat, S., et al., 2022, Factors affecting COVID-19 vaccine uptake in low- and middle-income countries. BMC Public Health, 22, 1230.

[11]. Janz, N. K., & Becker, M. H. 1984, The Health Belief Model: A decade later. Health Education Quarterly, 11(1), 1–47.

[12]. Glanz, K., Rimer, B. K., & Viswanath, K., (Eds.). 2015, Health Behavior: Theory, Research, and Practice (5th ed.). San Francisco, CA: Jossey-Bass (Wiley).

[13]. Alhassan, R. K., et al., 2021, COVID-19 vaccine hesitancy in Ghana: Experiences from the field. PLOS ONE, 16(11), e0261315. https://doi.org/10.xxxx

[14]. Leonardelli, I., et al., 2023, Applying the Health Belief Model to vaccine intention among adolescents. Vaccine, 41(2), 295–302.

[15]. Ghana Statistical Service (GSS), 2021, population and housing census. Accra: Ghana Statistical Service.

[16]. Ahmed, M., 2016, Determining sample size for research activities. Educational and Psychological Measurement, 30(3), 607–610.

[17]. Lamuda, P., et al., 2020, Age differences in COVID-19 vaccine hesitancy: A global perspective. Journal of Health Psychology, 25(6), 789–801.

[18]. Kengadaran, S., & Anusha, P., 2023, Awareness and attitudes towards COVID-19 vaccination in Tamil Nadu. Indian Journal of Public Health Research & Development, 14(3), 210–215.

[19]. Naidoo, R., et al., 2023, Cultural factors and vaccine uptake: Lessons from the COVID-19 pandemic. Social Science & Medicine, 317, 115571.

[20]. Alshagrawi, M. 2024, Predictors of COVID-19 vaccine uptake using the Health Belief Model. Journal of Public Health Research, 13(2), 245–257.

[21]. Abubakari, A., et al., 2023, Determinants of COVID-19 vaccine readiness and hesitancy among adults in Sub-Saharan Africa. BMC Public Health, 23(1), 112. https://doi.org/10.xxxx

[22]. Kuatewo, K., et al., 2025, Sources of COVID-19 vaccine misinformation and their impact on uptake in Ghana. Vaccine, 43(2), 221–229.

[23]. Rotenberg, S., et al., 2021, Accessibility of COVID-19 vaccination for people with disabilities. Disability and Health Journal, 14(4), 101117.

[24]. Roberts, R., et al., 2022, Interpersonal influences on COVID-19 vaccination decisions. Health Promotion International, 37(6), daac053.

[25]. Limbu, Y. B., et al., 2022, Gender differences in COVID-19 vaccine hesitancy: Insights from the Health Belief Model. Preventive Medicine, 158, 107014.

[26]. Odikro, A., et al., 2020, Strategies to improve COVID-19 vaccine acceptance in Ghana. African Journal of Health Sciences, 33(5), 1–10.

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Assessment of the Implementation Level of National Health Information System Policy on Data Quality and Information use in Ondo State, Nigeria

Author: Dorcas O. Johnson

DOI: 10.21522/TIJMD.2013.08.03.Art006

[ABSTRACT] [Full-Text PDF] [REFERENCES]

Assessment of the Implementation Level of National Health Information System Policy on Data Quality and Information use in Ondo State, Nigeria

Abstract:

To better understand the practical challenges of health data utilization in resource-limited settings, this study explored key factors affecting the use of the National Health Management Information System (NHMIS) in Ondo State. One of the foundational components of any health system, the Health Management Information System (HMIS), brings together data collection, processing, reporting, and usage. Although low- and middle-income countries (LMICs) have adopted health information systems as part of broader health reforms, they often encounter difficulties in generating high-quality data. A critical issue raised by district-level informants was the limited human capacity to apply analytical tools and methods necessary for converting data into actionable insights, largely due to insufficient training. To investigate this further, twelve (12) key informants were purposively selected based on their central roles in NHMIS data management within Ondo State. This study revealed that there is a Staff Shortage and Work Overload, Limited Training and Capacity Building, Inadequate Motivation and Incentives, Infrastructure and Tool Gaps, Irregular Supervision and Feedback, and Digital Literacy and Use of Technology. A lack of systematic investment in training, supervision, digital tools, and motivation schemes can even render the most well-designed health information systems ineffective in achieving their intended impact. As such, stakeholders must prioritise expanding the HMIS workforce, standardizing training, equipping facilities with necessary tools, strengthening supervision, and integrating a digital health system.

Assessment of the Implementation Level of National Health Information System Policy on Data Quality and Information use in Ondo State, Nigeria

References:

[1]. Gobena, T., Enyew, D. B., Kenay, A., & Wondirad, Y., 2024, Onsite training-mentoring intervention improves data quality: an implementation research. BMC Public Health, 24(1), 3110.

[2]. Nambiar, B., Hargreaves, D. S., Morroni, C., Heys, M., Crowe, S., Pagel, C., & Colbourn, T., 2016, Improving health-care quality in resource-poor settings. Bulletin of the World Health Organization, 95(1), 76.

[3]. Gobena, T., Enyew, D. B., Kenay, A., & Wondirad, Y., 2024, Onsite training-mentoring intervention improves data quality: an implementation research. BMC Public Health, 24(1), 3110.

[4]. Federal Ministry of Health (FMoH). 2025, Revised Policy on NHMIS. Abuja:FMoH.

[5]. Nutley, T., & Reynolds, H., 2013, Improving the use of health data for health system strengthening. Global health action, 6(1), 20001.

[6]. Uba, B. V., Waziri, N. E., Adegoke, O. J., Akerele, A., Gidado, S., Usifoh, N., & Nguku, P., 2021, Pilot implementation of a routine immunization module of the district health information system version 2 in Kano State, Nigeria, 2014-2015. The Pan African Medical Journal, 40(Suppl 1), 5.

[7]. Mboera, L. E., Rumisha, S. F., Mbata, D., Mremi, I. R., Lyimo, E. P., & Joachim, C., 2021, Data utilisation and factors influencing the performance of the health management information system in Tanzania. BMC Health Services Research, 21(1), 498.

[8]. Chaulagai, C. N., Moyo, C. M., Koot, J., Moyo, H. B., Sambakunsi, T. C., Khunga, F. M., & Naphini, P. D., 2005, Design and implementation of a health management information system in Malawi: issues, innovations and results. Health policy and planning, 20(6), 375-384.

[9]. Alemie, H. K., 2024, Assessing the Relevance of African-based Institutions in Becoming WHO Collaborating Centres in Digital Health (Doctoral dissertation, Hochschule für Angewandte Wissenschaften Hamburg).

[10]. Meekers, D., Olutola, O., & Turk, L. A., 2023, Using responsive feedback from routine monitoring data to guide course corrections for a family planning intervention in Nigeria. Gates Open Research, 7, 75.

[11]. Kawakyu, N., Coe, M., Wagenaar, B. H., Sherr, K., & Gimbel, S., 2023, Refining the Performance of Routine Information System Management (PRISM) framework for data use at the local level: An integrative review. PLoS One, 18(6), e0287635.

[12]. Wilms, M. C., Mbembela, O., Prytherch, H., Hellmold, P., & Kuelker, R., 2014, An in-depth, exploratory assessment of the implementation of the National Health Information System at a district level hospital in Tanzania. BMC health services research, 14(1), 91.

[13]. Glèlè Ahanhanzo, Y., Ouendo, E. M., Kpozèhouen, A., Levêque, A., Makoutodé, M., & Dramaix-Wilmet, M., 2014, July 24. Data quality assessment in the routine health information system: an application of the Lot Quality Assurance Sampling in Benin. Health Policy and Planning, 30(7), 837–843. https://doi.org/10.1093/heapol/czu067.

[14]. Yourkavitch, J., Prosnitz, D., & Herrera, S., 2019, Data quality assessments stimulate improvements to health management information systems: evidence from five African countries. Journal of Global Health, 9(1). https://doi.org/10.7189/jogh.09.010806.

[15]. Oladoyin, V., Adedini, S., Ijadunola, K., Ogunwemimo, H., Folorunso, O., Chukwu, E., Okoli, U., Adoghe, A., Oyeniyi, S., Adetiloye, O., & Fatusi, A., 2025, The assessment of routine health information system performance towards improvement of quality of reproductive, maternal, newborn, child and adolescent health services in Ondo and Ekiti States, Nigeria. PLoS ONE, 20(1), e0318010. https://doi.org/10.1371/journal.pone.0318010

[16]. Mambo, S. N., Odhiambo-Otieno, G. W., Ochieng’-Otieno, G., & Mwaura-Tenambergen, W., 2021, Health systems strengthening: assessing the influence of organizational factors of community health volunteers on use of community based health information systems in selected counties, Kenya. International Journal of Community Medicine and Public Health, 8(6), 2724. https://doi.org/10.18203/2394-6040.ijcmph20211975

[17]. Adefolarin, A. O., Gershim, A., Sola, A. O., & Oye, G., 2021, The effect of training and supervision on primary health care workers’ competence to deliver maternal depression inclusive health education in Ibadan, Nigeria: a quasi-experimental study. BMC Health Services Research, 21(1). https://doi.org/10.1186/s12913-021-07208-3

[18]. Gergen, J., Josephson, E., Coe, M., Ski, S., Madhavan, S., & Bauhoff, S., 2017, Quality of Care in Performance-Based Financing: How It Is Incorporated in 32 Programs Across 28 Countries. Global Health: Science and Practice, 5(1), 90–107. https://doi.org/10.9745/ghsp-d-16-00239

[19]. Zodpey, S., & Negandhi, H., 2016, Improving the quality and use of routine health data for decision-making. Indian Journal of Public Health, 60(1), 1. https://doi.org/10.4103/0019-557x.177248

[20]. Musoke, D., Ndejjo, R., Atusingwize, E., Mukama, T., Ssemugabo, C., & Gibson, L., 2019, Performance of community health workers and associated factors in a rural community in Wakiso district, Uganda. African Health Sciences, 19(3), 2784–2797. https://doi.org/10.4314/ahs.v19i3.55

[21]. Console, M., & Lenzerini, M., 2023, Editorial: Special Issue on Quality Aspects of Data Preparation. Journal of Data and Information Quality, 15(4), 1–2. https://doi.org/10.1145/3626461

[22]. Ihekweazu, C., Ossai, P., Nnaji, R., Osigwe, U., & Ngozi, M., 2019, Interoperability of Surveillance Data Collection Tools (District Health Information System 2 and District Vaccine Data Management Tools) in Enugu State, Nigeria, From 2015-2018. Iproceedings, 5(1), e15235. https://doi.org/10.2196/15235

[23]. Semo, B. W., 2014, Improving the quality of health information: a qualitative assessment of data management and reporting systems in Botswana. Health Research Policy and Systems, 12(1). https://doi.org/10.1186/1478-4505-12-7

[24]. Tang, X. Y., Yan, X. X., Wei, X., Qin, Q. L., Lin, Y. D., Geater, A., Deng, Q. Y., Zhong, G., & Li, Q., 2021, Timeliness, completeness, and timeliness-and-completeness of serial routine vaccinations among rural children in Southwest China: A multi-stage stratified cluster sampling survey. Vaccine, 39(24), 3236–3249. https://doi.org/10.1016/j.vaccine.2021.04.048

[25]. Jeilani, A., & Hussein, A., 2025, Impact of digital health technologies adoption on healthcare workers’ performance and workload: perspective with DOI and TOE models. BMC Health Services Research, 25(1). https://doi.org/10.1186/s12913-025-12414-4

[26]. Ogbuabor, D., Ghasi, N., Nwangwu, C., Okenwa, U., Ezenwaka, U., & Onwujekwe, O., 2023, Evaluating an Intervention to Improve the Quality of Routine Immunization Data and Monitoring System in Enugu State, Nigeria: A Pre-and Post-Study. Nigerian Journal of Clinical Practice, 26(Suppl 1), S103-S112.

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Bioequivalence Assessment of the Fixed Dose Combination of Linagliptin/Metformin (2.5mg/850mg) Film Coated Tablets in Healthy Human Subjects: A Randomized, Open-Label, Two-Period Crossover Study

Author: S. Chandrasekaran

DOI: 10.21522/TIJMD.2013.08.03.Art007

[ABSTRACT] [Full-Text PDF] [REFERENCES]

Bioequivalence Assessment of the Fixed Dose Combination of Linagliptin/Metformin (2.5mg/850mg) Film Coated Tablets in Healthy Human Subjects: A Randomized, Open-Label, Two-Period Crossover Study

Abstract:

Type 2 diabetes mellitus (T2DM) is a chronic, progressive disease with substantial global prevalence and far-reaching health consequences. Combination oral anti-diabetic therapies often provide greater glycemic control compared to monotherapy. Among these, the fixed-dose combination (FDC) of linagliptin and metformin is widely used due to complementary mechanisms of action that enhance glycemic management: metformin acts predominantly via hepatic and peripheral insulin sensitization, while linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, amplifies incretin activity to promote insulin secretion and inhibit glucagon release. The present study investigates the bioequivalence of two formulations, each containing 2.5mg linagliptin and 850mg metformin, under fasting conditions in healthy Indian males. A single-center, open-label, randomized, two-period crossover trial was conducted. The study enrolled 28 healthy male volunteers, each receiving single doses of both the test and reference formulations with a 36-day washout. Pharmacokinetic (PK) parameters (C_max, AUC_0–t, AUC_0–∞, T_max, t_1/2) were assessed using validated LC-MS/MS. Bioequivalence was determined by the 90% confidence intervals (CIs) for the geometric mean ratio (GMR) of ln-transformed C_max and AUC remaining within 80–125%. The results confirmed bioequivalence, as all CIs fell within the regulatory limits. No significant adverse events were observed, and both drugs were well tolerated, supporting their interchangeable use in clinical practice in India.

Bioequivalence Assessment of the Fixed Dose Combination of Linagliptin/Metformin (2.5mg/850mg) Film Coated Tablets in Healthy Human Subjects: A Randomized, Open-Label, Two-Period Crossover Study

References:

[1]. U.S. Food and Drug Administration (FDA), 2013, Guidance for Industry: Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA. CDER.

[2]. European Medicines Agency (EMA), 2010, Guideline on the Investigation of Bioequivalence. EMA/CHMP/EWP/1401/98 Rev 1/Corr*.

[3]. Indian Council of Medical Research (ICMR), 2017, Ethical Guidelines for Biomedical and Health Research Involving Human Participants. New Delhi: ICMR.

[4]. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), 2016, Guideline for Good Clinical Practice E6(R2). ICH Harmonized Tripartite Guideline.

[5]. DeFronzo, R. A., Goodman, A. M., 1995, Efficacy of metformin in patients with non-insulin-dependent diabetes mellitus. N Engl J Med., 333(9):541–549.

[6]. Vedtofte, L., Knop, F. K., Vilsbøll, T., 2017, Efficacy and safety of linagliptin for the treatment of type 2 diabetes. Expert Opin Pharmacother., 18(9):859–865.

[7]. Nauck, M. A., Vilsbøll, T., Gallwitz, B., et al., 2009, Incretin-based therapies: viewpoint on the way to consensus. Diabetes Care., 32(Suppl 2):S223–S231.

[8]. Zhang, L., He, L., Gong, L., et al., 2021, Diabetes mellitus and the risk of cardiovascular events and death: a meta-analysis of prospective cohort studies. BMC Cardiovasc Disord., 21(1):1–11.

[9]. Peters, N. H. G. M., De Smet, P. A. G. M., van der Worp, H. B., et al., 2021, Bioequivalence and generic drugs: a European perspective. Eur J Clin Pharmacol., 77:1769–1776.

[10]. Kamal, M. A., Alexiou, A., Zaman, G. S., 2015, Bioequivalence assessment: A review on its importance in generic product development. Int J Pharma Sci Res., 6(8):788–793.

[11]. Scordo, M. G., Aklillu, E., Yasar, Ü., et al., 2020, Bioequivalence studies: regulatory aspects and global trends. Eur J Clin Pharmacol., 76:151–160.

[12]. Owusu Obeng, A., Hamada, Y., Ebieyan, S., et al., 2019, Bioanalytical method validation in pharmacokinetic studies: regulatory framework and scientific challenges. J Pharm Biomed Anal., 170:630–638.

[13]. Bailey, C. J., Turner, R. C., 1996, Metformin. N Engl J Med., 334:574–579.

[14]. Battelino, T., et al., 2015, Clinical efficacy and safety of linagliptin and metformin in type 2 diabetes: a review. Adv Ther., 32(7):599–618.

[15]. Holstein, A., Plaschke, A., Egberts, E. H., 2017, Lower incidence of hypoglycemia with DPP-4 inhibitors. Diabetes Obes Metab., 19(7):950–957.

[16]. Wienen, W., Diefenbach, K., Bader, G., et al., 2010, Linagliptin, a xanthine-based DPP-4 inhibitor. Biochem Pharmacol., 80(6):861–870.

[17]. Inzucchi, S. E., Bergenstal, R. M., Buse, J. B., et al., 2015, Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach. Diabetes Care., 38(1):140–149.

[18]. Chaturvedi, N., Matthews, D. R., et al., 2018, Study designs for generic fixed-dose combination formulations: regulatory expectations. Int J Clin Pharmacol Ther., 56(11):518–535.

[19]. U.S. Food and Drug Administration (FDA), 2001, Statistical Approaches to Establishing Bioequivalence. CDER.

[20]. Swanson, J., et al., 2020, Generic substitution and therapeutic equivalence in diabetes management. Drug Healthc Patient Saf., 12:103–112.

[21]. Remuzzi, G., Schieppati, A., 2019, Guidelines for drug bioequivalence and bioavailability studies. Br J Clin Pharmacol., 85(3):424–432.

[22]. World Medical Association, 2013, Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. JAMA., 310(20):2191–2194.

[23]. EMA, 2010, Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples. EMA/INS/GCP/532137/2010.

[24]. EMA, 2009, Guideline on bioanalytical method validation. EMEA/CHMP/EWP/192217/2009.

[25]. Chae, Y. S., et al., 2021, An overview of bioequivalence study designs and regulatory approaches worldwide. Ther Innov Regul Sci., 55:1328–1343.

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Table of Contents - Issue

October 2025

Volume 8 | Issue 3

Recent articles

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