Comparative analyses of type 2 diabetes mellitus care at primary and tertiary healthcare settings in Malta: A cross-sectional study

INTRODUCTION

Diabetes mellitus (DM) is a global epidemic, with the International Diabetes Federation (IDF) reporting that by the end of the year 2021, 537 million adults were living with DM (IDF Diabetes Atlas 10^th Edition, 2021).^[1] When compared with the year 2019, a 16% (74 million) raise in newly diagnosed DM has been noted (IDF Diabetes Atlas 10^th Edition, 2021).^[1] DM is also a cause of morbidity and mortality in Malta. Malta is a small European country in the middle of the Mediterranean Sea with a total population of 0.54 million for the year 2022 (Trading Economics 2022).^[2] In 2018, it was reported that in Malta, DM contributed to 5.6% of total deaths in males and 5.7% of deaths in females [National statistics office (NSO) annual report 2018].^[3]

Diabetes has a significant impact on the quality of life of persons with diabetes and their families, especially when complications arise (IDF Diabetes Atlas 10^th Edition, 2021).^[1] The rise in Type 2 DM (T2DM) is driven by a complex interplay of socio-economic, demographic, environmental, and genetic factors (Cuschieri, 2020).^[4] The key contributors to this epidemic in Malta have been noted to include urbanization, an aging population, decreasing levels of physical activity, and increasing prevalence of overweight and obesity (Ministry of Health Malta. Diabetes: A National Public Health Priority A National Strategy for Diabetes, 2016–2020).^[3]

MATERIAL AND METHODS

Malta has both a public healthcare system, known as the government healthcare service and a private healthcare system. On the island of Malta, there is one government tertiary hospital Mater Dei Hospital (MDH), while another smaller tertiary hospital (Gozo General Hospital) is situated on the smaller sister island of Gozo. Across the islands, there are 10 government primary health centers (HCs) situated in different localities. These medical facilities offer primary care service for free to all tax paying citizens as well as European Union (EU) citizens on presentation of a valid European health insurance card (Cuschieri, et al., 2019).^[5] On the other hand, there are numerous private hospitals and clinics where people can attend healthcare services against an out-of-pocket fee. In Malta and Gozo, patients with T2DM are either diagnosed incidentally at our tertiary hospital or during routine follow-ups at primary HCs or through private clinics. Patients with T2DM can then be followed up at the endocrinology department at the tertiary hospital or also at HCs’ diabetic clinic which is manned by general practitioners with special interest in diabetes. The latter service has been set up in partnership with the tertiary hospital to increase the accessibility and enhance the management care of T2DM.

An anonymous questionnaire was created by the authors. The questionnaire gathered data including the demographics of the responder, which T2DM guidelines are used by the doctor, which investigations are booked for T2DM patients, what treatment is started on diagnosis, and what is done in situations of uncontrolled T2DM. Quantitative analyses were performed on the free text, with different themes being identified and reported. A copy of the questionnaire is found as part of the Supplement material. In addition, a comparative analysis of the different T2DM guidelines considered as part of this study can also be found as part of the Supplement material.

RESULTS

A total of 101 participated, with a male predominance (55.4%). The participant demographic characteristics are shown in Table 1. Most of the responders (29.7%) were between the ages of 31 and 40 years.

DISCUSSION

T2DM poses a major threat to health and our economy not only on an individual and population level but also on a global level (IDF Diabetes Atlas 10^th Edition, 2021).^[1] T2DM pathophysiology, diagnostic criteria, and treatment modalities have been established throughout the centuries (Cuschieri, 2019).^[5] Even though across the years, numerous medical advancements for T2DM have been established, T2DM prevalence is on the rise worldwide.

Most diabetic patients in the western world are diagnosed in the primary HCs. Overall, primary health care is associated with lower costs of care, higher satisfaction of the population with its health services, better health levels, and lower medication use (Starfield, 1994).^[6] In Malta, a Maltese Transition Project was carried out in HCs between 2001 and 2004, and it has shown that from 12,227 patients encountered by general practitioners, 398 (88%) of those patients had T2DM (Soler and Okkes, 2005).^[7] In Malta, newly diagnosed patients with DM are typically diagnosed by their general practitioner at the HC during regular health check-ups (Soler and Okkes, 2005).^[7]

In fact, general practitioners (GPs) have an active role in the management of diabetic patients as they provide routine medical care, including ordering laboratory investigations, undergoing physical examinations, and providing medicine prescriptions. GPs also act as a bridge of care for T2DM patients and the rest of the multi-disciplinary team, including endocrinologists, ophthalmologist podiatrists, pharmacists, registered nurses, registered dietician nutritionists, certified diabetes care and education specialists, mental health professionals, fitness professionals (Bonner et al., 2016).^[8] On the other hand, endocrinologists who specialize in DM can provide the patient with their expertise, tools, and resources specific to their individual symptoms and condition (Soler and Okkes, 2005).^[7] In fact, a study performed by Healy et al. (2018)^[9] concluded that even though general practitioners are fundamental for caring for patients with T2DM, it is beneficial for patients with T2DM to be seen at least once by endocrinologists, particularly when diabetes is poorly controlled. Indeed, this echoes the findings of our study.

It is fundamental for doctors who are working in primary HCs and those working in tertiary centers to keep up to date with continuous advancements in research and technology to fight the T2DM epidemic (Healy et al., 2018).^[9] This has resulted in the development of multiple guidelines to standardize appropriate therapy and to disseminate the information (Grol et al., 1998).^[10] The Institute of Medicine (IOM) defines clinical practice guidelines as “statements that include recommendations intended to optimize patient care, that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options” (Shekelle, 2022).^[11] Guidelines highlight current literature and new evidence, and they create an easy stepwise approach to the management of diseases, the targets for disease control, and the standards of care. In fact, the use of guidelines in clinical practice improved the quality of care received by patients (Shekelle, 2022).^[11] When doctors use different guidelines as part of their care treatment plan, they expose their patients to different investigations, treatments, and continuity of care (Grol et al., 1998).^[10]

In our study, both doctors working in primary HC and those at MDH mainly made use of NICE guidelines. Different reasons may be contributing to the doctors’ preference toward the NICE guidelines, which may vary between the ease of guideline accessibility, to the guideline recommendations that are more acceptable to Maltese patient, among others. It is recommended that further research targeting the reasons behind the doctors’ preference toward guidelines is carried out.

Patients with T2DM (especially the elderly) should undertake resistance training at least 2–3 times/week (Sato, 2020).^[12] Only NICE and IDF guidelines give recommendations on prescribing exercise regimens in T2DM. Given that most participants, locally follow the NICE guidelines, the majority of T2DM individuals are being prescribed regular exercise (NICE guidelines, 2015 and IDF, Recommendations For Managing Type 2 Diabetes In Primary Care, 2017).^[13]

T2DM patients should be referred to the ophthalmic department yearly as DM may result in diabetic retinopathy (Turbert, 2021). NICE, WHO, and ADA guidelines suggest that the doctor should refer to an ophthalmologist upon diagnosis, whereas IDF suggests screening every 1–2 years. This is reflected in the results, more so in those working in HCs, as most clinicians in Malta refer to ophthalmology as per NICE guidelines. Doctors in HCs could be referring their patients to ophthalmology more due to various reasons, such as different level of expertise in ophthalmic examination. Doctors practicing at the HC may also be choosing to refer their patients to focus on other aspects of the diabetic consultation whilst leaving the specialist to focus on any eye pathology (Turbert et al., 2021).^[14]

All drugs, including metformin, have their side effects. It is important for prescribers to monitor drug side effects as these side effects may show ineffective drug treatment, non-compliance, and adverse drug reactions (Dighriri et al., 2021).^[15] NICE guidelines discuss the importance of uptitrating metformin slowly to reduce the risk of gastrointestinal side effects, as well as stresses the importance of monitoring side effects and the effect this has on drug compliance. A good number of participants (over 80%) do, in fact, discuss this with their patients (NICE guidelines, Dec 2015).

Considering that the NICE guidelines were the preferred T2DM management guide for the participating doctors, it was expected that all management care pathways for T2DM would be similar. Yet, some differences could be observed.

Dietary factors are of paramount importance in the management and prevention of type 2 diabetes (Sami et al., 2017),^[16] yet different guidelines provide different recommendations. The WHO and NICE guidelines agree on their dietary recommendations, while IDF has its own recommendations. Even though most doctors in our study claim to follow the NICE guidelines, not every doctor tackles dietary habits during consultations. (NICE guidelines, Dec 2015. IDF. Recommendations for Managing Type 2 Diabetes in Primary Care, 2017. WHO; 2020).

Patients should be referred to podiatry to prevent peripheral vascular disease and peripheral diabetic neuropathy (Bonner et al., 2016).^[8] NICE guidelines suggest that only if a limb or life-threatening foot problem occurs should the clinician immediately refer otherwise, patients require education as part of the management. However, almost three-fourths of our study’s doctors refer their patients to podiatry even though this is not recommended by NICE guidelines.^[17] This can be due to various contributing factors such as the physician’s gender, own expertise, as well as doing what other physicians are doing within the HCs (IDF. Recommendations For Managing Type 2 Diabetes In Primary Care, 2017.^[18] WHO; 2020). (Turbert et al., 2021).^[14]

The initiation of T2DM pharmacologic therapy is mostly based on the HbA1c level (Dighriri et al., 2021).^[15] Different guidelines recommend different HbA1c levels for initiation of treatment, yet all agree that metformin is the initial drug of choice. NICE guidelines provide different target ranges; however suggests that for those controlling their diabetes with lifestyle and a single drug of choice, the target should be 6.5. This is a much lower threshold than those reported by this study and might suggest that the local doctors follow different guidelines than the NICE when it comes to initiation of treatment based on HbA1c. It may also be reflective that the Malta patients carry different characteristics that merit a higher HbA1c threshold for initiation of treatment. However, this merits further research.

Although it was observed that doctors in Malta prefer to follow the NICE guidelines in managing T2DM, differences were still evident in their practices. Yet, some practicing doctors opt to follow other guidelines rather than the NICE guidelines. Considering that other guidelines provide different recommendations; with caution, one would speculate that patients with T2DM are not receiving the same care, with potentially different management plans. It is evident that doctors need a standardized local guideline. Such guideline needs to be constructed by considering the different practices and local patients’ characteristics as well as the availability of medicines and healthcare services to ensure that the best standardized care management plan is offered to the local T2DM population.

CONCLUSION

Different guidelines are being followed by caring T2DM doctors in Malta, resulting in the delivery of different management plans. A standardized local guideline is recommended to be developed to ensure that optimal management is provided to patients with diabetes living in Malta.