COMPLIANCE OF MEDICAL PRACTITIONERS WITH DIABETIC TREATMENT GUIDELINES AT DR YUSUF DADOO HOSPITAL, WEST RAND HEALTH DISTRICT GAUTENG Dr NJ OHANSON Student Number: 2061778 A publishable article as a research report submitted to the Faculty of Health Sciences, University of the Witwatersrand in partial fulfilment of the requirements for the degree of Master of Medicine in Family Medicine (M.Med in Family Medicine) Supervisor: Dr D Pretorius MSc (Psych) BSocSc (SW), PhD Family Medicine (Family Medicine University of Witwatersrand) Johannesburg, 2022 ` ii DECLARATION I, NJ OHANSON, hereby declare that this research is my own unaided work, except where due acknowledgement for assistance received has been made. It is being submitted for the degree of Master of Family Medicine at the University of the Witwatersrand, Johannesburg. It has not been submitted previously for any other degree or examination at this or any other university. Signed ……………………….. (Signature of candidate) Date: December 2022 Signed ……………………… Dr D Pretorius (Supervisor) Date: December 2022 ` iii ACKNOWLEDGEMENT I would like to thank my immediate supervisor Dr Pretorius for her guidance, as well as the Head of Department and all my supervisors at the West Rand Health District, including the lecturers at the University of the Witwatersrand, Johannesburg. Also, a special thanks goes to Dr Moshe Magethi for his help in conceiving this project. This author also extends a sincere thanks to the clerks of Dr Yusuf Dadoo Hospital who assisted in the retrieval of patient records which made the data for this project a success. ` iv DEDICATION I dedicate this research report to my family, particularly my Mom, for all the unconditional support and understanding of the sacrifices required for the completion of this work. ` v TABLE OF CONTENTS DECLARATION .....................................................................................................................ii ACKNOWLEDGEMENT ........................................................................................................ iii DEDICATION ........................................................................................................................ iv LIST OF FIGURES ............................................................................................................... vi LIST OF TABLES ................................................................................................................. vii NOMENCLATURE .............................................................................................................. viii COMPLIANCE OF MEDICAL PRACTITIONERS WITH DIABETIC TREATMENT GUIDELINES AT DR YUSUF DADDO HOSPITAL WEST RAND HEALTH DISTRICT GAUTENG………………………………………………………………………………..…………. ix ABSTRACT ............................................................................ 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ARTICLE REQUIREMENT…………………………………………………………………………21 Acknowledgment…………………………………………………………………………………....21 Competing Interests………………………………………………………………………….……..21 Authors contribution………………………………………………………………………..……….21 Funding Information…………………………………………………………….…………………..21 Data Availability……………………………………………………………………………………..21 Disclaimer …………………………………………………………………………………………...21 APPENDICES…………………………………………………………………………………...….22 Appendix I: Data collection tool.………………………………………………………………….22 Appendix II: Patient Information and Consent forms…………………..……………………….25 Appendix III: SEMDSA organisation of care ………………………………...………………….30 Appendix IV: Ethical Clearance certificate …………………….………………..………………32 Appendix V: Permissions…………………………………………………………………...……..33 Appendix VI: Turnitin report…………………………….…………………………………………35 Appendix VII: Proof reading certificate….…………………………………………….…………36 Appendix IX: Research proposal…………………………………………………………….…...37 ` vi LIST OF FIGURES Figure 1: Multi-layered consequence of non-compliance with DM guideline ` vii LIST OF TABLES Table 1: Patient profile as documented in the reviewed file……………………………6 Table 2: Documented routine examination in reviewed files…………………………..7 Table 3: Documented number of examinations in reviewed files……………………..7 Table 4: Documented routine investigations, glycaemic and target organ damage in reviewed files…………………………………………………8 Table 5: Adequacy of diabetes control according to SEMDSA guidelines of 2017…………………………………………………………..9 ` viii NOMENCLATURE ARV : antiretrovirals BMI : Body Mass Index COPD : Chronic Obstructive pulmonary disease DHIS : District Health Information System DM : diabetes mellitus DPN : Diabetic Peripheral neuropathy ECG : Electrocardiogram IDF : International Diabetes Federation LDL : low density lipoprotein OPD : Out-patient Department SEMDSA : Society Endocrinology Metabolism and Diabetes South Africa SSA : Sub-Saharan Africa ` ix Compliance of medical practitioners with diabetic treatment guidelines in Dr Yusuf Dadoo Hospital, West Rand Health District, Gauteng. An article submitted according to the style guide and requirements of the African Journal of Primary Health Care & Family Medicine (PHCFM). ` x Abstract Background: Diabetes (DM) is a common chronic condition. The prevalence is increasing globally and has become a common health care problem associated with multiple complications. Guidelines have been formulated to standardise care among people living with DM, with aim of optimising patient care and thus minimising the complications. Aim: The aim of this study was to assess how well health care practitioners in Dr Yusuf Dadoo Hospital complied with the most recent diabetic treatment guideline, SEMDSA 2017. Setting: This study was conducted in the out-patient department of Dr Yusuf Dadoo hospital in the Westrand Health district of Gauteng. Methods: A retrospective cross-sectional review of patient record living with diabetes was done. Three hundred and twenty-three Record of patients seen from August 2019 to December 2019 were reviewed and some of the basic variables were assessed according to the most recent diabetic treatment guidelines SEMDSA 2017. Results: files were audited in 4 main categories. Comorbidities, Examinations. Investigations, presence of complications. In terms of monitoring parameters, only 40(12.4%) had HbA1c assessed 6monthly, with annual creatinine assessed in 179(55.4%) and lipogram 154(47.7%) of patients. More than 70% of patients had uncontrolled glycaemia. More than 70% of patients had uncontrolled glycaemia. The most frequently documented target organ screening/examinations were foot related at 8.7% (28) and all of them had established complications. Only 2 people were screened for erectile dysfunction. Conclusion: Adherence to DM treatment guidelines was found to be poor. Monitoring and control parameters were infrequently done as per guideline recommendation. The resultant effect are poor glycaemic control and therefore numerous complications. The study site and thus the West rand needs targeted strategies to improve medical practitioner adherence to guidelines including adequate interpretation of results, timely intervention, when necessary, as a way to improve DM care and thus minimise the risk of complications amongst patients in the district Keywords: Adherence; Compliance; Diabetes; Medical practitioners; treatment guidelines; SEMDSA guidelines ` xi INTRODUCTION There has been a rise in the prevalence of diabetes mellitus (DM) in Africa and sub- Saharan Africa (SSA) due to increasing urbanisation and economic development.1 About 415 million people are living with DM globally and the estimated national prevalence in South Africa is estimated at 15.25%.2 The rise in prevalence in Africa and Sub-Saharan Africa (SSA) could probably be due to the increasing urbanization and economic development in the region.3 The increase in rural-urban migration has also led to changes in food and diet. The difference in dietary trends has moved from fresh foods to over-processed and canned food.4 There is also a corresponding increase in a sedentary lifestyle, which predisposes to obesity as a significant risk factor for diabetes.4 The current HIV epidemic in Sub- Saharan Africa (SSA) and with associated increasing use of Anti-Retroviral therapy (ARVs) also increased the risk of insulin resistance.5 Furthermore, the effect of the COVID 19-pandemic with it’s seemingly bidirectional relationship with diabetes, increase the number of patients living with diabetes in South Africa.6 In addition, the presence of DM significantly increases the risk of severe disease and mortality compared to people without DM.7 A systematic review of 49 articles assessing the quality of primary care on diabetic outcomes has, found that high-quality primary health care was associated with clinical guideline compliance that also significantly reduced hospital admissions and complications for people living with DM.8 Quality clinical care is important and therefore the question was raised to what extent did doctors comply with guidelines in the management of patients living with diabetes in West Rand Health District, Gauteng. Guidelines have been formulated in various countries globally to standardise, improve, and optimise the quality of care for patients with diabetes mellitus. Clinical guidelines are systematically developed recommendations that assist medical practitioners in making informed clinical decisions to improve the management of diabetes. They are derived by synthesising high-quality scientific evidence regarding specific aspects of patient care.9 Benefits and risks are weighed against the evidence gathered and recommendations are translated into guidelines. The objectives of clinical care guidelines, therefore, are to standardise and ensure uniformity of patient care, thereby ` xii improving the quality of patient care and minimising risks.9,10 Health care compliance therefore refers to the process of abiding with all legal, professional and ethical standards in health care.11 In South Africa, the Society for Endocrinology Metabolism and Diabetes South Africa (SEMDSA) has formulated clinical guidelines to provide guidance on the most appropriate management for people with diabetes. In addition, clinical guideline on DM, enhance diabetes prevention efforts, reduce the burden and complications of the disease and inform clinical decisions made by health care practitioners.12 Although clinical guidelines on diabetes are readily available in various clinical settings in South Africa, despite the advances in scientific evidence based clinical recommendations, several studies show that physicians adhered poorly with diabetic treatment guidelines.13,14 Treatment gaps have been found in various other studies regarding the management of DM among patients locally and abroad, and they have also been found to be associated with poor adherence with clinical guidelines.15,16 In Norway and Switzerland, the researchers discovered significant discrepancies between the laid down clinical guidelines and the practices of healthcare practitioners.17,18 In addition, the Diab–Africa project, done across six countries in sub- Saharan Africa, has found that less than half of patients had glycaemic levels and monitoring parameters assessed in the study year.19 Similarly, Kibirige et al20 in Uganda has found that glycaemic, blood pressure control and screening for diabetic complications were poorly done by healthcare workers. In two South African studies, it was found that healthcare practitioners complied poorly with the recommended diabetes treatment guidelines. In a district hospital in KwaZulu- Natal, poor health outcomes were mainly contributed to poor adherence with the current diabetic guidelines.21,21 In Kwa-Zulu Natal only 25% of patients had their HbA1c levels done the preceding year, and in Tshwane, Pretoria, there was infrequent monitoring of glycaemia in terms of the audited files (half of which had no blood glucose recorded, and more than 80% had no urine testing done).20,22 The National Development Plan aimed already in 2017 to reduce the disease burden to manageable levels and decrease medico-legal risks and litigation.23, 24 Guidelines protect doctors and following it curb costs by decreasing the burden of disease and its complications, ` xiii preventing additional diagnostic examinations, and simultaneously decrease the risk of litigation.23, 24 The researcher observed clinical inconsistencies, and sub-optimal patient care in her workplace that were anecdotally attributed to possible poor adherence to clinical guidelines, burn out and excessive workloads. The concern is that a lack of standardised care would lead to numerous complications among these patients which by itself is not only to the detriment of the patient, but also increases the work burden. The need to assess adherence to guidelines was identified. In addition, this seems to be the first study assessing adherence with the guidelines in this district. The aim of this study, therefore, was to assess how well medical practitioners working at a district hospital in Westrand adhered with the most recent diabetic treatment guidelines (SEMDSA 2017).12 METHODS AND DESIGN Study design: A retrospective cross-sectional review of patient records was done.. Setting: The setting was the Out-patient Department (OPD) of Dr Yusuf Dadoo Hospital, Krugersdorp, in the Mogale Municipality in the West Rand Health District of Gauteng with a population of about 383 864 (according to the 2016 population survey). An average of 10−15 patients with diabetes are seen daily at this OPD. Sampling: The target population are adult patients living with diabetes attending regular follow-up at the OPD at this hospital. The files of patients living with diabetes older than 18 years at this OPD clinic between April 2018 and March 2019 were estimated to be about 2112 per annum by the District Health Information System (DHIS) information. The sample was calculated with Epi-info software version 725 using a confidence interval of 95% and a sample error of 5%, 343 files were reviewed while 20 files were discarded based on the exclusion criteria. The records of patients seen from 1st August 2019 to 31st December 2019 were eligible for review. Convenience sampling - a non-probability sampling method, was used where every file on the Diabetes OPD register was audited in a consecutive manner until the sample size was reached. As patients consulted more than once during the sampling period; repeat files were only captured once and the most recent version ` xiv during the selected period, was audited. The most basic variables were assessed according to the most recent diabetic treatment guidelines SEMDSA 2017.11 The SEMDSA guidelines was used as the gold standard for DM care. The core aspects measured in this study, is incorporated in hospital guidelines and thus evidence-based diabetes management. Selection was done using the diabetes daily register of patients in the OPD. Medical records of patients that presented for ambulatory care and who were diagnosed for at least one year with diabetes were included in the study. Files of patients seen during weekends and pregnant diabetics were excluded from the study. Files not meeting inclusion criteria were discarded for the research and the next file was selected until sample size was reached. Where a file could not be traced, the next file was selected. Data collection and tools: The OPD register was used as a primary source of patient records, whereafter the administrative staff were asked to retrieve files. The researcher then assessed whether the files met the inclusion criteria, and a tracking list was completed. When a file met the inclusion criteria, the researcher included this in the data collection list; thereafter the file was marked as being audited and returned to the archives. The 2017 SEMDSA11 guideline was used to develop the tool and variables were extracted from the document. The patient profile of reviewed documents included the following variables selected from the guideline: • Co-morbid conditions • Presence of complications • Routine examination: for feet, blood pressure, waist circumference, Body Mass Index (BMI), weight • Medications • Routine Investigations to screen for presence of target organ damage: i.e., glucose testing at each visit, 3-6 monthly HbA1c, annual lipogram, annual serum creatinine and eGFR, urine dipsticks, urine albumin creatinine ratio Data Analysis: Data were captured onto an Excel spreadsheet and analysed using STATA vs 16. Descriptive analyses were used to summarise the data, and results were presented in tables. ` xv Limitations: Convenience samples have low external validity or generalizability, therefor the study must be interpreted within the context of the study. Using files in a consecutive manner limited sampling, selection and researcher bias that are common in convenience sampling. Failure to document examination or investigation findings were reported as not done, even if the patient might have had the benefit of the service, as this study reflects on recorded data. Ethical Considerations: Permission to conduct the study was obtained from the Human Medical Ethics Committee University of the Witwatersrand (M200117) and the Gauteng Health Research Committee Database (GP_202007_010). No identifiers of persons were used; thus, all data were anonymous and confidential. As the study was a retrospective record review of archived files, patient consent was not required. Data will be stored safely for a period of two years after publication of the results, after which it will be discarded in a safe manner. RESULTS: Three hundred and forty-three files were reviewed, while the 20 files that did not meet the inclusion criteria were discarded. Therefore, three hundred and twenty- three patient files were reviewed. This translates to the records of 165 (51%) women and 158 (48.9%) men who were reviewed (Table I). The mean age of the patients was 60 and more than half (195; 60.4%) were unemployed. In terms of co-morbidity, hypertension was the most frequently documented condition (Table I). Two hundred and eighty (86.7%) patients lived with hypertension, 27 (8.4%) had arthritis, 23 (7.1%) had gout; 21 (31.7%) had asthma, and chronic obstructive disease (COPD) as co-morbidities. In addition, one hundred and eighty patients 180/323 (55.7%) were taking oral cholesterol-lowering therapy. This is shown in Table 1. Table 1: patients profile as documented in the reviewed files(n=323) ` xvi `Further, it should also be noted that only 36/323 (11%) patients were referred to annual eye assessment to either optometry or ophthalmology, but the results of assessments were not documented in patient records. Although documented foot examinations were done, they were for only 28/323 (8.7%) of patients. In addition, the SEMDSA guideline requires referral to a dietician, and adequate health education by the attending physician; however, only 129 (39.9%) patients were referred to a dietician and 204 (63.4%) had documented health education. In terms of the documented routine examinations, the analyses of all the files reviewed (100%) had blood pressure measurements done and recorded. However, other examinations – foot exam, fundoscopy, weight, BMI and injection sites were markedly absent (see Table 2). Demographics Categories frequency Percentage Gender Women 165 51.1 Men 158 48.9 Employment Employed 128 39.6 Unemployed 195 60.3 Hypertension Yes 280 86.7 Current medication Oral agents 187 57.9 Insulin only 35 10.8 Oral & insulin 144 44.6 Simvastatin 180 55.7 ` xvii Table 2: Documented routine examinations in reviewed files (n=323) Examination Frequency Percent Blood pressure 322 99.7 BMI 38 11.8 Weight 37 11.5 Fundoscopy 36 11.1 Foot exam 28 8.7 Waist Circumference 8 2.5 Injection Sites 7 2.20 BMI: Body Mass Index In addition, the most frequently documented complication was diabetic foot complications which included (neuropathy, foot- ulcers, gangrene) for 28 (8.7%) patients. Cardiovascular and renal complications (nephropathy) were also common (see Table 3). Table 3: Documented number of complications in reviewed files (n= 323) Complication Frequency Percentage (%) Foot complications 28 8.7 Cardiovascular 24 7.4 Nephropathy 22 6.8 Retinopathy 19 5.9 Erectile dysfunction 2 3.7 Others 3 0.9 Unknown 225 69.7 In the performance of routine investigations and screening for target organ damage, at each clinic visit, 99% of all patients had blood glucose checked and documented at each clinic visit. One hundred and sixty-four (50.65%) patients had HbA1c checked the previous year, and of these only 14 (4.3%) had levels <7%. Six-monthly HbA1c ` xviii was done for 40 (12.4%) patients and only three patients had their HbA1c assessed more than twice that same year (Table 4). One hundred and fifty-four 154(47%) of patients had an annual lipogram test. Ninety nine of these 154(64%) had TC levels less than 4,5mmol/l. LDL test results were consistently greater than 1.8mmol/l in 62.3% of these patients. More than half of patients had serum creatinine and eGFR measured and documented. Of these only 51% had normal results. One hundred and sixty-four 164(50.6%) patients had Urine dipsticks done, but only 11 of these patients had urine albumin-creatinine ratios assessed. Table 4: Documented routine investigations, glycaemic and target organ damage in reviewed files (n=323 Examinations Done(n) Percentage HGT 322 99.7 3 monthly HbA1c 3 0.9 6 monthly HbA1c 40 12.4 Annual HbA1c 164 50.8 Annual serum creatinine 179 55.4 Annual Lipogram 154 47.7 Urine dipsticks 164 50.8 Urine Albumin: creatinine ratio 11 3.4 HbA1c: glycated haemoglobin test ` xix Table 5: Adequacy of Diabetes control according to SEMDSA 2017 Indicator SEMD SA CUT OFF NUMBER ABOVE CUT OFF PROPORT ION (%) Mean (SD) Media n Range HbA1c ≥7 111/164 67.6% 9.54 (2.23) 9.60 15.95 Serum creatinine ≥ 90 87/179 48.6% 81.20 (38.06) 78.0 0 3.04 Total cholesterol ≥ 4.45 55/154 35.7% 4.45 (1.05) 4.30 6.01 LDL > 1.8 96/154 62.3% 2.28 (0.41) 2.35 5.34 HDL ≤ 1.2 100/154 64.7% 1.28 (0.41) 1.30 1.91 HbA1c: glycated haemoglobin test LDL: Low density lipoprotein HDL: High density lipoprotein DISCUSSION In this study, the compliance of doctors with diabetic treatment guidelines in the management of diabetic patients in a district hospital are explored. The results show poor compliance across various aspects of the SEMDSA guidelines. Markers of control and other process-of-care indicators were either not being done or not being documented. According to the International Diabetes Federation (IDF),1 DM is on the increase in low-income countries. The consequences of poor compliance with diabetic treatment guidelines are increases in morbidity and mortality, resulting in poorer outcomes. Glycaemic control as measured by Hba1c is the single most important factor in assessing the control in diabetic patients because it has a strong predictive value for diabetic complications and is thus the best indicator of the effectiveness of diabetes care.26 Most of the research on diabetes has shown that diabetic complications are directly related to glycaemic levels and the prevalence of diabetic complications sharply and significantly increase as the glycaemic levels rise. 27 The recommended glycaemic target is 7%, and every 1% above this level has been associated with a 38% to 40% higher risk of micro and macrovascular complications, as well as death.27, ` xx 28 The finding of this study in terms of glycaemic monitoring and control, therefore, also shows that irregular monitoring is likely to contribute to poor glycaemic control. The fact that this study shows inadequate assessment and monitoring of glycaemic control could mean increased risk of complications in these patients. These negative findings are similar to various local studies in South Africa and many countries in the African continent.14,21,22 Research suggested that low income countries, for example Mexico also have poor compliance to guidelines.29 In contrast, in high income countries, glycaemic monitoring in USA and Europe was done at recommended intervals showing a higher compliance rate with guidelines.30 31 Developed countries have a higher doctor to patient ratio that could contribute to more time per consultation and probably better adherence and /or documentation of the consult. The researcher acknowledges the differences in health care systems and resources in these countries, but also hypothesized that a more structured approach to diabetic patient care and a lower patient-to-doctor ratio compared to their South African counterparts can contributed to better adherence and management of DM in developed countries. The consequence of poor glycaemic monitoring and control are complications. Diabetic foot problems were the most common complication found in this study and it is interesting to note that all patients who had a documented foot exam had abnormal findings. The SEMDSA guidelines were designed to prevent, and limit complications when regular screening is done. However, in this present study, it is unclear if the foot exams were done due to complaints or following guidelines. Even though the present study did not establish the duration of DM, the risk of diabetic peripheral neuropathy (DPN) increases with the duration of diabetes and it’s presence is associated with the presence of microalbuminuria and diabetic kidney dysfunction.33 Further, one in every five individuals living with diabetes is likely to have diabetic neuropathy, with the risk of severe neuropathy evolving to amputations in about 6% of the diabetic population.33,34 In addition, peripheral neuropathy causing DM foot problems have been associated with sexual dysfunction in men. Thus, lack of screening in diabetic peripheral neuropathy could suggest patients with ED were missed.35 It is thus imperative that medical practitioners strengthen and improve the evaluation and diagnosis of DPN, in addition to familiarising themselves with essential aspects of the ` xxi Diabetic foot exam details found in the SEMDSA guideline. This is because timely screening by regular foot examinations will enable earlier detection of foot problems and the instituting of timeous interventions. Interestingly, even though more than 50% were male patients, only two patients had erectile dysfunction (ED) documented. However, sexual dysfunction cuts across gender lines and is a commonly missed symptom in patients with chronic conditions.36 Further, ED is common among people living with DM, and an additional biomarker for coronary events.37 The prevalence of ED is estimated to be as high as 70% in Africa, and the risk increases with just one year of being diabetic and is made worse in the setting of poor glycaemic controls.38 During consultations with patients, sexual history is often not taken by healthcare workers; thus patients living with sexual dysfunction are missed. In a study done to assess care among patients living with chronic disease in the Northwest Province of South Africa, the examination of sexual dysfunction was found to be grossly neglected. Nearly all the male patients had sexual dysfunction and more than 80% of the female patients had symptoms suggestive of sexual dysfunction.39 In other studies done by Pretorius et al, sexual symptoms were investigated by way of enquiry in only two patients of the total number consulted.40,41 This, therefore, indicates that a significant number of patients with ED may have been missed or alternatively not being documented and, therefore, they are most likely not receiving the care they deserve. This healthcare check warrants the appropriate regular screening and intervention for sexual dysfunction in all patients living with DM regardless of sex. Developing effective communication skills and adequate training of healthcare workers to enable them to identify patients with sexual dysfunction would be a positive step in eliciting this complication and institute targeted treatment in people living with DM. Significantly, the increasing prevalence of DM has inadvertently led to an increase in diabetic kidney disease. Microalbuminuria is often used as an early marker for diabetic kidney disease detected via the urine albumin-creatinine ratio (Urine ACr) and proteinuria (urine dipsticks) as the hallmark of kidney disease.42 Besides glycaemic monitoring, renal function monitoring has been identified as the main factor in the preventing the development of renal failure.43 Furthermore, in the presence of diabetes, there is a more rapid decline in renal function worsening with poor control. This complication could be minimised in the first place if the Urine Albumin-Creatine https://www.sciencedirect.com/topics/medicine-and-dentistry/sexual-dysfunction ` xxii test is combined with other aspects of the kidney function test, as it is a useful way to identify early kidney dysfunction, institute treatment and slow down further decline. Basic urine dipsticks can be used to minimize cost, by regular screening and thus identify patients who need the urine ACS testing thereby identifying patients with Diabetic kidney disease early. cheaper and basic urine dipsticks are done and appropriately interpreted. However, given the low inclination to screen for microalbuminuria among patients in this present study, combined with the setting of poor glycaemic controls, it is very likely that many patients with progressive diabetic renal failure are being missed who could have benefited from early referral to nephrologists to slow progression to end stage renal disease. The findings of this study are limited to adherence with a guideline; however, the consequence of non-compliance is multi-layered. The findings of this study are to be seen in the direct and indirect implications of non-adherence with guidelines, as shown in Figure 1. Figure 1: Multi-layered consequence of non-compliance with DM guidelines. The findings of this study have a huge impact on not only clinical care as discussed, but also on patients’ wellbeing, the health system and the healthcare providers’ professionalism, For the patient there is an increase in missed workdays leading to Professional conduct Health system Patient wellbeing Clinical care DM Guideline C o n s e q u e n c e s NON- COMPLIANCE ` xxiii job losses, increase in the number of years lost due to resulting disability and overall, a reduction in quality of life.44 Not only is a patient failed, but an entire family and eventually a community. The effects are also not lost on the health care worker who are open to litigation on account of substandard care.45 23 24 It may be that care was given but if not documented could be interpreted legally as not done.46 Besides, the effect on the health care system is enormous. The financial cost needed to care for DM patients with complications from DM, such as prosthesis for foot amputees, dialysis for renal complications to name a few exerts further burden on the already strained health care system.47 Adequate care given to patients by complying with guidelines could help minimise these negative consequences. This study highlighted the non-adherence of health workers with diabetic treatment guidelines in a Westrand district hospital. Physician related factors and health care system were identified to contribute to poor adherence with treatment guidelines by medical practitioners as well as the guideline implementation process,.48 So upon reflection, the researcher could relate some of these factors identified in other research contributing to poor adherence, also could apply to this study, such as inadequate numbers of staff; professional failure to keep up with latest guidelines; excessive patient load; overburdened health care workers resulting in burnout; poor organisation, and patient flow. These in the researcher’s opinion can be mitigated by the medical practitioners updating themselves with latest clinical guidelines, implementing a booking system in the health care system to prevent clogging of patients on certain days, ensuring that guidelines are widely disseminated and readily available to medical practitioners. In addition, it is imperative that there is a review of how treatment guidelines are implemented, disseminated, and utilised to improve patient management and outcomes. Therefore, recommendations from this study include more studies required to assess possible barriers to adherence with guidelines by medical practitioners and encourage regular quality improvement cycles to improve medical-practitioner actions. Following the outcome of this research in the Westrand, the district has undertook a quality improvement project in the district to improve Hba1c and DM management in all 54 facilities in the district including the research site. CONCLUSIONS ` xxiv Adherence with DM guidelines were poor in this study despite evidence that guidelines ensure good standard of care, decreased the risk for complications and generally provided better health outcomes for patient. Not following guidelines put the patient and the profession at risk. ARTICLE REQUIREMENTS Acknowledgement: The authors wish to thank Dr Moshe Magethi for help with conceiving the concept of the study and facilitating contact with the records section staff of Dr Yusuf Dadoo hospital. Also, thanks to Prof O Omole who suggested a figure in the discussion to emphasize our conclusion. Funding: The study was fully funded by the researcher. Competing Interests: The authors declare that they have no financial, personal relationship or interests which may have influenced this study, Author Contribution: Original research design, proposal: NJO, DP and MM. Data collection: NJO. Data analysis: NJO and DP. Research supervision: DP and final manuscript: NJO and DP. Funding Information: The authors received no financial support for the research, authorship and/or publication of this article. Data Availability statement: The datasets generated during and/or analysed during the current study are available upon reasonable request. 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Defining Healthcare Compliance: What Does it Really Mean? | [Internet]. Strategic Management Services, LLC. [cited 2022 Dec 14]. Available from: https://www.compliance.com/resources/defining-healthcare-compliance/ 12. The Society for Endocrinology Metabolism and Diabetes of South Africa Type 2 Diabetes guidelines. 2017 SEMDSA Guideline for the management of Type 2 diabetes mellitus. Jemdsa. 2017; 22(1): S1-S196. [Internet]. [cited 2021 Dec 5]. Available from: http://www.kznhealth.gov.za/family/SEMDS-2017-Guidelines.pdf ` xxvi 13. Klisiewicz AM, Raal F. Sub-optimal management of type 2 diabetes mellitus - a local audit : original research. J Endocrinol Metab Diabetes South Afr [Internet]. 2009 [cited 2022 Mar 26];14(1):13–6. Available from: https://journals.co.za/doi/abs/10.10520/EJC64185 14. Pinchevsky Y, Butkow N, Raal FJ, Chirwa T. The implementation of guidelines in a South African population with type 2 diabetes: original research. 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Available from: https://doi.org/10.1155/2020/5148370 39. Pretorius D, Couper ID, Mlambo MG. Neglected sexual dysfunction symptoms amongst chronic patients during routine consultations in rural clinics in the North West province. Afr J Prim Health Care Amp Fam Med [Internet]. 2021 [cited 2022 Jun 15];13(1):1–7. Available from: https://doi.org/10.4102/phcfm.v13i1.2850 40. Pretorius D, Couper I, Mlambo M. Sexual History Taking: Perspectives on Doctor-Patient Interactions During Routine Consultations in Rural Primary Care in South Africa. Sex Med [Internet]. 2021[cited 2022 Jun 15];9(4):100389. Available from: https://doi.org/10.1016/j.esxm.2021.100389 41. Pretorius D, Mlambo MG, Couper ID. Perspectives on sexual history taking in routine primary care consultations in North West, South Africa: Disconnect between patients and doctors. Afr J Prim Health Care Fam Med [Internet]. 2022 [cited 2022 Jun 15];14(1):10. Available from: https://doi.org/10.4102/phcfm.v14i1.3286 42. Griffin TP, O’Shea PM, Smyth A, Islam MN, Wall D, Ferguson J, et al. Burden of chronic kidney disease and rapid decline in renal function among adults attending a hospital- based diabetes center in Northern Europe. BMJ Open Diabetes Res Care [Internet]. 2021[cited 2022 Mar 26];9(1):e002125. Available from: https://doi.org/10.1136/bmjdrc- 2021-002125 43. Tuttle KR, Bakris GL, Bilous RW, Chiang JL, de Boer IH, Goldstein-Fuchs J, et al. Diabetic Kidney Disease: A Report From an ADA Consensus Conference. Diabetes Care [Internet]. 2014 [cited 2022 Mar 26];37(10):2864–83. Available from: https://doi.org/10.2337/dc14- 1296 ` xxix 44. Rodríguez-Almagro J, García-Manzanares Á, Lucendo AJ, Hernández-Martínez A. Health-related quality of life in diabetes mellitus and its social, demographic and clinical determinants: A nationwide cross-sectional survey. J Clin Nurs [Internet]. 2018 [cited 2022 Jul 6];27(21–22):4212–23. Available from: https://doi.org/10.1111/jocn.14624 45. Lewis K. Professionalism – A Medico-Legal Perspective. Prim Dent J [Internet]. 2021 [cited 2022 Jul 8];10(2):51–6. Available from: https://doi.org/10.1177/20501684211018573 46. Yankowsky KW. Avoiding Unnecessary Litigation: Communication and Documentation. Adv Skin Wound Care [Internet]. 2017 Feb [cited 2022 Jul 8];30(2):66–70. Available from: https://doi.org/10.1097/01.ASW.0000511697.33786.fa 47. The Cost of Diabetes Care—An Elephant in the Room | Diabetes Care | American Diabetes Association [Internet]. 2018[cited 2022 Jul 9]. Available from: https://doi.org/10.1186/s12992-017-0318-5 48. Hashmi N, Khan S. Adherence To Diabetes Mellitus Treatment Guidelines From Theory To Practice: The Missing Link. J Ayub Med Coll Abbottabad JAMC. 2016[Accessed 2022 N0ov 06];28:802–8. ` 0 ` 0 APPENDIX 1: DATA COLLECTION SHEET NOS DEMOGRAPHICS CORMOBID CONDITIONS COMPLI CATION MEDICATIONS LIFE- STYLE 1 AGE GENDER RACE EMPLOY HPT OTHERS COMPLI CATIONS ORAL INJECT. Alcohol/ smoking 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ` 0 DATA COLLECTION SHEET 2: N O S ROUTINE EXAMINATION ROUTINE INVESTIGATIONS B P Fu nd o sco py Fo ot Ex am We igh t Wai st Cir cu m. B M I Inj ect sit es H G T HB AI C 3nt hly HB AIC 6m nthl y Ser um Cr eat . Li pid s Uri ne dip sti x Ur in e A C R E C G K H I V Di et ici an Ph ysi ci cad re To tal poi nts 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 ` 0 TRACKING SHEETS Nos Date File Number Date of Record Review Others ` 1 CODE- Data collection sheet 1  Gender: 1=Male, 2 =Female  Race: 1=Black, 2=White, 3= Coloured, 4= Indian, 5= Others  Co-morbid conditions: 1= Hypertension, 2= Athritis, 3=Gout, 4=Thyroid, 5=Asthma, 6=HIV  Complications. • 1= Cardiovascular, • 2= Renal, • 3= Retinopathy, • 4= Diabetic foot ulcer/chronic limb Ischaemia • 5=Erectile dysfunction  Medications: • Oral: 1=Metformin, 2=Glimepiride, 3=Both. • Injectables: 1=Long acting, 2 = Short acting, 3=Both.  Lifestyle; 1= alcohol, 2= Smoking, 3=both CODE: Data collection sheet 2  Examinations: Done -1, Not done- 2  Physician- • 1-registrars • 2- Medical officers • 3- Interns/Community Service Doctors • 4- Clinical Associates • 5= Doctor + Intern/Community Service Doctors • 6=Interns + clinical Associates • 7=Doctors+ Interns+ Clinical Associates • 8=Doctor + Clinical Associates  Referral to dietician 1= referral, 2 = No referral ` 2 APPENDIX II: PATIENT INFORMATION AND CONSENT FORMS PATIENT INFORMATION SHEET STUDY TITLE Compliance of medical Practitioners with Diabetic Treatment guidelines at Dr Yusuf Dadoo Hospital, West Rand Health District. Good day, I am Dr Nneka Jamie Ohanson, a second year family medicine registrar at the University of Witwatersrand and in the West Rand Heath District. I am conducting a Study to see if Medical practitioners comply with Diabetic treatment guidelines in the management of Diabetic Patients. Invitation to participate: I am inviting you to participate in the above titled research. Why are we doing this study? The study will enable the researcher to assess the current level of practice among the health care practitioners in the hospital regarding your diabetic care and identify areas that are not up to standard. Areas of poor practice will be identified and addressed; and changes will be implemented to improve your overall diabetic care. What is involved in the study: The study will be a retrospective cross-sectional study. It will involve the researcher going through your files and checking to see if your routine monitoring blood investigations for diabetes are done as recommended by the Society for Endocrinology, Metabolism and Diabetes of South Africa (SEMDSA) guideline by your healthcare practitioner. Risks of being involved in the study: Participation is voluntary and there are no risks involved in participating in this study. It is a review of your file in the hospital. ` 3 Benefits of participating in this study: Participating in this study will aid in the improvement your diabetes care by your healthcare practitioner. Confidentiality? Participating in this study by review of your hospital files/record will not expose you to any prejudice, risk or harm. Personal information will be treated with the strictest confidence and will be only available to the Principal Investigator and her supervisor. The findings and recommendations of this study will be made known to the staff and authority of the clinic, the district and also to you upon request. The findings of this study will also be published in a Journal for academic purposes. Participation is voluntary: There will be no penalty or loss of benefits if you refuse to participate. You may also discontinue participation at any time without penalty or loss of benefits. Refusal to participate in this study will not jeopardize or expose you to any prejudice, risk or harm. If you have any concerns or queries regarding the way the study is conducted, please contact: The Researcher - Dr NJ Ohanson @ jamieohanson@gmail.com / 0604373153 OR The Research Supervisor –Deidre Pretorius @ Deidre.Pretorius@wits.ac.za You can also contact The Chairperson of the Human Research and Ethics Committee, University of Witwatersrand Professor Clement Penny by telephone 0n 011 717 2301 or by email on Clement.Penny@wits.ac.za. The telephone numbers of the committee secretariat are 011 717 2700/1234 and the email addresses are Zanele.Ndlou@wits.ac.za and Rhulani.Mukansi@wits.ac.za Thank you for reading this study information sheet. 9th July 2019 mailto:jamieohanson@gmail.com mailto:Deidre.Pretorius@wits.ac.za mailto:Clement.Penny@wits.ac.za mailto:Zanele.Ndlou@wits.ac.za mailto:Rhulani.Mukansi@wits.ac.za ` 4 CONSENT FORM I hereby confirm that I have been informed about the above project. I am aware that the result of this project, including personal details will be dealt with anonymously. If I choose not to give consent this will not prejudice my treatment in any way. I ……………………………………………………………………………………. hereby give consent for my medical records to be used for the purpose of the above mentioned research. Signature:…………………………………… Date…………………… Witness 1………………………………………. Witness 2……………………………………….. ` 5 APPENDIX III- SEMDSA GUIDELINE ` 6 ` 7 APPENDIX IV: ETHICAL CLEARANCE CERTIFICATE ` 8 APPENDIX V: PERMISSION TO CONDUCT RESEARCH FROM DR YUSUF DADOO HOSPITAL ` 9 APPENDIX VI: PROVINCIAL APPROVAL ` 10 APPENDIX VI – TURNITIN REPORT ` 11 APPENDIX VII PROOF EDITING CERTIFICA ` 12 APPENDIX - VII RESEARCH PROPOSAL COMPLIANCE OF MEDICAL PRACTITIONERS WITH DIABETIC TREATMENT GUIDELINES AT DR YUSUF DADOO HOSPITAL, WEST RAND HEALTH DISTRICT, GAUTENG STUDENT: DR OHANSON N.J STUDENT NUMBER: 2061778 SUPERVISOR: DEIDRE PRETORIUS CO- SUPERVISOR: DR MOSHE MAGETHI DEPARTMENT OF FAMILY MEDICINE UNIVERSITY OF THE WITWATERSR ` 13 CONTENTS 1. INTRODUCTION 4 2. LITERATURE REVIEW 5 3. AIMS AND OBJECTIVES 7 3.1 Aims 7 3.2 Objectives 7 4. METHODOLOGY 8 4.1. Study design 8 4.2. Site of Study 8 4.3. Study Population 8 4.4. Sampling and Sample Size 8 4.5. Inclusion and Exclusion Criteria 9 4.6. Selection or Recruitment of Participants 10 4.7. Measuring tool and Data Collection 10 4.8. Study Period 11 4.9. Pilot Study 11 4.10. Data Analysis 11 5. ETHICAL CONSIDERATIONS 13 6. LIMITATIONS 13 7. FUNDING 13 8. TIME FRAME 14 9. REFERENCES 15 APPENDIX 1: DATA COLLECTION SHEET 19 APPENDIX 2: TRACKING SHEETS 21 APPENDIX 3: LETTER OF PERMISSION TO THE CLINICAL MANAGER TO CONDUCT RESARCH 22 APPENDIX 4: LETTER OF PERMISSION TO THE DISTRICT MANAGER TO CONDUCT RESEARCH 23 APPENDIX 4: PATIENT INFORMATION SHEET 24 TABLE 1: DESCRIPTION OF HOW DATA WILL BE ANALYZED 12 TABLE 2: BUDGET 14 TABLE 3: TIME FRAME 15 ` 14 ABBREVIATIONS DM- Diabetes Mellitus DYD- Dr Yusuf Dadoo Hospital EDU- Education Employ- Employment HTN- Hypertension CVS - Cardiovascular Inject- Injectable Phys active- Physical activity Fund. -Fundoscopy BMI-Body Mass Index K+ - Potassium Serum Crea - Serum creatinine Urine ACR- Urine Albumin Creatinine Ratio SEMDSA- Society for Endocrine, Metabolism and Diabetes South Africa ` 15 1. Introduction and Background Diabetes (DM) is the most common endocrine disease. According to the 2015 WHO report,415 million people are living with diabetes globally. Previously, diabetes was believed to be a disease of affluence occurring in the developed world, characterizing its high incidence in the western world. However, according to the International Diabetes Federation (IDF), Africa is in the last 30years experiencing a dramatic increase in the prevalence of diabetes.1,2 The rise in prevalence in Africa and Sub-Saharan Africa (SSA) could probably be due to the increasing urbanization and economic development. The increase in rural-urban migration and development has led to dietary changes; from fresh foods to over processed, canned and unhealthy foods a risk factor for DM. Also, there has been a corresponding increase in sedentary lifestyle, which predisposes to obesity another significant risk factor for diabetes. The current HIV epidemic in SSA with associated increasing use of Anti-Retroviral therapy (ARVs) has also increased the risk of insulin resistance which is a risk factor for diabetes..3,4 All of these factors contribute to the increasing prevalence of DM seen in Africa and could partly explain the dramatic rise. Optimal diabetes management and control requires reliable and efficient access to diagnosis, treatment and monitoring. This assists in improving the care, preventing and identifying early complications.5 Scientific advances have improved the management of diabetes over the years, and these have been constructed into diabetic treatment guidelines and chronic care modules and adapted for use by various countries globally. However, several studies have shown that the quality of diabetes care generally lags behind evidence-based care recommendations.6,7,8 Compliance with guidelines has been found to improve quality of diabetes care. A meta-analysis found the standards of care significantly improved after initiating a quality improvement project to greater than 80% in the select quality indicators.9 Comparably, several studies found that patients whose caregivers adhered to testing guidelines had better glycaemic control than those who did not and thus, better outcomes.9,10 There is increasing concern globally, especially in Africa regarding poor adherence to clinical guidelines by healthcare practitioners.6,7,8 To standardize, improve and optimize the quality of care for diabetic patients, guidelines have been formulated in ` 16 various countries globally usually by the diabetic association with the aim of standardizing and improving care. In South Africa, the Society for Endocrinology, Metabolism, Diabetes South Africa(SEMDSA) and the National Department of Health South Africa have formulated and distributed widely diabetic treatment guidelines in South Africa.5.11 The instructions contained have recommendations for frequency of visits, assessment of complications, risk factor modification, pharmacological treatment, monitoring and appropriate intervention to abnormal result. However, despite these advances, management and treatment outcomes continue to remain suboptimal in South Africa, sub-Saharan Africa (SSA) and the higher resourced countries.6,7,8,12,13 Several reasons have been proposed for the clinical inertia by physicians to adhere to clinical guidelines. They include lack of clear national policies regarding management, limited resources with poor access to medications and other aspects of care such as necessary investigations, limited national health budgets, inadequate training of attending health include poor understanding of guidelines, ignorance of the existence of guidelines, lack of resources to assist implementation, disagreement with the guidelines, simply forgetting to use it.14,15 Dr Yusuf Dadoo hospital district hospital lies in West Rand Health District, Gauteng. About 80-100 patients are seen daily in the Outpatient department (OPD) of the hospital, usually by doctors, clinical associates and medical interns. The researcher has observed inconsistencies and erratic behaviours in following diabetic treatment guidelines by medical practitioners. This behaviour in the researcher's opinion would lead to an increase in complications. Besides, there is a paucity of data to determine how well clinical guidelines are complied with to in managing chronic disease such as diabetes in West-Rand health district of South Africa. The focus of this study is to assess how well medical practitioners in Dr Yusuf Dadoo hospital adhere to diabetic treatment guidelines. The guideline of focus is the SEMDSA guideline of 2017. This is the most recent version of diabetic treatment guideline in South Africa, in the management of diabetic patients in the out-patient department of Dr Yusuf Dadoo Hospital. The result of the study will assist stakeholders in determining if interventions are required to improve the quality of care amongst diabetic patients in the hospital. ` 17 1.2 Literature Review 1.2.1 Key Focus and Trends Adherence to clinical guidelines and recommendations regarding the management of diabetes and optimizing care have shown not only to reduce complications but improve outcomes and quality of care.5,6, Regular monitoring and appropriate intervention to abnormal result have been shown to reduce complications such as renal failure, diabetic foot ulcers, retinopathy.9,10 However, several studies have shown that physicians do not adhere to guidelines and thus treatment outcomes remain suboptimal globally especially in Sub Saharan Africa including South Africa.6,7,8,12,13 In the developed and advanced countries where it is expected that adherence levels to guidelines would be higher; investigations find that adherence levels are not at target standard. In a study done in Norway, the researchers discovered significant discrepancies between the laid down clinical guidelines and the practices of healthcare practitioners.15 Similarly, in Switzerland, an investigation into the adherence level among medical practitioners regarding diabetic treatment guidelines found good adherence in the significant aspects of management but found certain aspects where control could be improved.16 It appears that even the western countries do not have it all figured out. Poor compliance with diabetic treatment guidelines among medical practitioners is a global issue. Sub-Saharan Africa is also experiencing a similar dilemma. In Uganda, glycaemic, blood pressure control and screening for diabetic complications was found to be poorly done by healthcare workers. Testing for dyslipidaemia, foot exam, retinopathy performed in this study was 14%, 21%, 15% and diabetic neuropathy was the most prevalent complication in 31% of the patients.8 In Mozambique and Zambia, another study found poor access to healthcare workers with appropriate training and understanding of diabetes.17 This resulted in poor d application of healthcare guidelines in the management of patients by the unskilled healthcare workers. Most patients were found to have complications and poor outcomes, significantly increasing the cost of diabetic care. An average cost in Mali for DM care was found to be about 70% of mean monthly income.18 ` 18 In South Africa, studies done compare poorly with their westernised counterparts. In a multicentre cross-sectional study done across South Africa, Amod et al. found that 70% of patients were not optimally controlled. Glycaemic control was poor: management by their physicians was suboptimal and needed improvement.6 Similarly, a study done in a district hospital in KwaZulu-Natal South Africa has shown that poor compliance with current diabetic guidelines among physicians was the main reason for poor outcomes. Only 25% of patients had their HbA1C levels done the preceding year and patients were found to have an increase in diabetic complications.13 In a study done in rural Hlabisa, KwaZulu-Natal South Africa, monitoring of glycaemia was infrequent, half of them had no blood glucose recorded, and more than 80% had no urine testing done. In addition, there was a high rate of diabetic complications. This study found a shallow adherence rate to recommended treatment guidelines by healthcare practitioners.12 Similarly, in Pretoria, a study was done to assess diabetic care and complications in primary health care in Tshwane district found the standard of care to be suboptimal and patients fraught with complications.19It is thus imperative that compliance with diabetic treatment be the norm among medical practitioners rather than the opposite. Another study done in South Africa among specialist physicians and GP’s who received education about treatment guidelines and care strategies showed improved diabetic care and outcome. There was a 90% reduction in hospitalization among diabetic patients. This study showed that compliance with diabetic guidelines was possible and had tremendous benefits to patients and the healthcare system.14,20 Interventions based on the chronic care modules done in Soweto South Africa also improved the critical thinking of primary healthcare nurses and made them more critical of their management of DM patients leading to improvement in patient care.21 2. RESEARCH QUESTION AND OBJECTIVES This study aims to assess the medical practitioner adherence to diabetic treatment guidelines in the management of diabetic patients attending the out-patient department of Dr Yusuf Dadoo Hospital. The objectives are: 1. To review and describe the demographic profiles of diabetic patients attending the out-patient department. ` 19 2. To assess adherence to SEMDSA guidelines of 2017 in terms of organization of diabetes care related to:  Symptoms of hyperglycaemia and duration of symptoms.  Screening for significant risk factors: hypertension, dyslipidaemia, abdominal obesity, family history  Screening for co-morbid conditions: hypertension, HIV, epilepsy, osteoarthritis, asthma.  Screening for complications: retinopathy, nephropathy, diabetic foot, cardiovascular, erectile dysfunction.  Routine examination of feet exam, blood pressure, waist circumference, weight, BMI.  Performance of routine investigations: Glucose testing at each visit, 3-6 monthly hba1c, annual lipogram, annual serum creatinine & eGFR, urine dipsticks, urine albumin creatinine ratio and ECG.  Documentation of lifestyle modification methods such as quitting smoking, alcohol. 3. Correlate the professional level of medical practitioners with compliance. 3. METHODOLOGY 3.1 Study design A retrospective cross-sectional review of diabetic patient records will be carried out.22 The study will assess compliance of medical practitioners according to the SEMDSA 2017 guideline,5 the most recent published South African diabetic treatment guideline launched in May 2017. The suitability of this study design is due to its ability to allow the researcher to make inferences about a population characteristic from a subset of the population at a specific or given point in time.22 3.2 Site of Study This study will be carried out in the outpatient department (OPD) of Dr Yusuf Dadoo Hospital, a District Hospital in the West Rand Health District of Gauteng. It is situated in Mogale municipality in the West Rand Health District of Gauteng with a population of about 364,422 (270.03/km) according to the 2011 census. An average of 80-120 patients are seen daily at the OPD, and 15-20 patients of these have diabetes. ` 20 3.3 Study Population The target population is confirmed diabetic patients, older than 18 years attending regular follow up at the OPD of Dr Yusuf Dadoo Hospital. According to the District Health information system, there was 2112 diabetic patient seen from 1st April 2018 – 31st March 2019. 3.4 Sampling/Sample Size The files of patients living with diabetes older than 18years attending Dr Yusuf Dadoo Hospital between April 2018 and March 2019 is estimated by the District Health Information system (DHIS) information to be about 2,112. Using the sample size calculator developed by the company Rao Soft,23 the confidence interval was taken at 95% and a sample error of 5%, the minimum number of files for the audit will be 323. Therefore, the research will carry out a record review of at least 323 patient files. 3.5 Inclusion and Exclusion Criteria- Inclusion Criteria • All the male and female diabetic patients 18 years and older. • Patients presenting for ambulatory care • Diagnosed for at least one year with diabetes. Exclusion Criteria • Pregnant diabetics • Diabetic emergencies • Patients are seen during weekends and in the emergency department. • Files of patients documented and before the publishing of the 2017 SEMDSA guideline. 3.6 Selection or recruitment of participants The number of diabetic patients seen at the OPD is entered daily into a DM record data book by the OPD sisters and kept at the Nurses station at the clinic. The name and file number of patients are recorded daily from Monday to Friday, excluding weekends and public holidays. The sister in charge will be notified after getting permission from the clinical manager about the research, and the data entry book will be retrieved from the station. The ` 21 researcher will then identify patient files for record review by selecting patient file numbers of patients seen from 1st August – 31st December 2018. Sampling will be done using the purposive sampling method of all the patient files seen from the 1st August 2018 -31st December 2018 September until the required sample size is gotten. The first file to be reviewed will be identified using a random number generator. After identifying the first file for review, then every next file would be reviewed until the sample size is gotten. If a file selected does not meet the inclusion criteria, then the next file would be selected. The clinical manager would inform the record clerks before commencing data collection. The record clerks will be given file numbers of records retrieved from the DM data entry book for retrieval of files. Data from record review would be captured using a data collection sheet. (See Appendix 1) Data will be captured daily until during the researcher's lunch break until the minimum number of files is gotten. Patient record review will be done for one hour during the researcher's lunch breaks every day from Monday to Friday until the minimum number of files is gotten. This study will commence immediately after HREC approval. Data collection will be done solely by the researcher. Tracking sheets will be used to document and keep track of patients' details such as file number and date of patient record review. The use of tracking sheets will ensure that files are not captured twice. 3.7 Measuring tool/Data collection Please refer (Appendix 1). The data collection tool will assess records according to the 2017 SEMDSA guidelines.5 The guideline was launched in May 2017 during the 52nd congress of the society. It includes the baseline characteristics of the patient age, sex, race and education level, and routine monitoring parameters as stated in the SEMDSA guidelines5: hba1c, lipid profile, blood pressure, serum creatinine, urine albumin creatinine ratio, weight and BMI, waist circumference, foot exam, eye exam and referral to a dietician. It also includes the professional level of healthcare professionals who adhere and follow the guideline. (Medical officers, Community service doctors, Interns and clinical associates).24 ` 22 The SEMDSA standard requires a 100% level of compliance to guidelines by medical practitioners to achieve the optimal required level of care for diabetic patients. Therefore, levels of compliance will be categorized as adherent, partially adherent, poorly adherent, non-adherent following assessment of adherence to the SEMDSA guideline from the record review. The SEMDSA guideline is the most popular and comprehensive guideline compiled by the South African diabetic society for South Africa, and it is the equivalent of the American Diabetic Association (ADA) in South Africa. The Essential Drug List (EDL) 11compiled by the South African department of health pulls its resource and information form the SEMDSA guideline, and it is a summarized and brief version. Medical practitioners are expected to be familiar with various chronic guidelines regardless of the availability of EDL and get more comprehensive and up-to-date information. 3.8 Study Period The study will commence following ethics approval. (see Gant Chart-Table 3). Patient record from 1st August 2018 – 31st December 2018 will be reviewed. This period has the highest number of patients seen in the OPD of Dr Yusuf Dadoo Hospital after May 2017 when the SEMDSA 2017 guideline was published. 3.9 Pilot Study A pilot study will be conducted with a sample of 10 records in the OPD. This study will be done one month after submission to the assessor group meeting. The data will be coded and will not be used for the final analysis; the patient records used will be excluded from the research sample. This pilot study aims to see if the data collection sheet is working, practical, required information from files are available and how long it takes to capture information from one file.25 Also, to assess and compare SEMDSA guideline to the Essential drug list (EDL) and assess which guidelines medical practitioners use more in their practice. Also, to find out which aspects of the guidelines medical practitioner healthcare practitioners adhere to, ascertain the critical parts of the guideline and enable the researcher to know what aspects to focus on in the guideline. ` 23 3.10 Data Analysis Data will be entered in an Excel data spreadsheet and imported into STATA version 13 for analysis. Table 1: Description of how data will be analysed Objectives Analysis Outcome Describe demographic characteristics: • Categorical variables like gender, race. • Continuous variables like age Descriptive stats such as frequencies and percentages. Range, Mean, and Standard deviation- eg: If there are 100 patients, 10 (10%) whites, 80 black (80%), 5 coloured (5%) and 5 Indians (5%) Specific age and age range. the age range of 20-30 yrs,30 +/- 8.5 SD Assess the records against the SEMDSA guidelines in terms of –hba1c, lipid profile, serum creatinine, urine dipstick, urine ACR, ECG, blood pressure, weight, BMI. Assessing the recommended frequency of tests and variables of diabetic patients. Descriptive stats such as frequencies. Standardized scoring according to SEMDSA recommendation. Adherence to each variable will be classified as complete(C), Partial (P), Poor compliance (PC) or Non-adherent(N) Standardized scoring according to SEMDSA criteria: Complete/Ideal compliance will be 100%, >80% partial compliance, 50-80% poor compliance, < 40% non- adherent. To assess and correlate the professional level of medical practitioners involved in patient care with compliance and control of diabetes. Bi-variate analysis using chi-square and multivariate analysis using logistic regression. In this study, the P-value of <0.05 and 95% CI will be Standardized scoring according to SEMDSA criteria: Complete/Ideal compliance will be 100%, >80% partial compliance, 50-80% poor compliance, < 40% non- adherent. ` 24 considered as statistical significance. Adherence to each variable will be classified as complete(C), Partial (P), Poor compliance (PC) or Non-adherent(N) Assessment of lifestyle modification/practises, examinations and Investigations will be considered as critical aspects of adherence. Each point adds up to a total of 20 for the three critical areas above. 100% of these points will be considered as complete adherence, >80% partially adherent, 40-80% poor compliance and 40% non-adherent. 4. Ethical considerations  Ethics clearance will be sought and received from the Human Research Ethics Committee before commencing the study.  Confidentiality of patient details and baseline characteristics will be kept by ensuring there is a data code link file/tracking sheet which would be kept away and accessed only by the researcher. Patient information and file number will be coded and kept separate in a code link file by using tracking sheets. (Refer Appendix 2)  Permission will be sought from the clinical manager of Dr Yusuf Dadoo hospital before commencing the study. (Appendix 3).  Permission would also be sought, and approval obtained from West Rand Health District Director before commencing the study. (Refer appendix 4).  Result of data analysis will be made known to the district manager and facility manager of the hospital. The findings from the study will also be published and distributed in an Academic Journal.  Raw data will be stored for five years in a safe box with lock and key only known by the researcher if not published and two years if published. It will be discarded by shredding them after they are no longer needed. 5. Limitations and Bias of the study. ` 25 The study will be done in a single centre in the district and thus may limit the generalization of the findings. 6. Funding for the Research Costs will be carried by the researcher Table 2: Budget Item Cost per item and number needed Estimate Data collection sheets 10 pages @ R4 each R40 Pens 2 x R15 R30 Travelling to hospital None. The Researcher works there Gifts/ cool drinks, for clerks, to collect and return files. 3 x 200 R600 Statistician Available @ WITS - Proofreading 17 pages @ R50 per page R850 Printing of protocols /Research Report R3,000 Total R4,520 Table 3: Time Frame July 24 2019 Aug 15, 2019 Sept 26 2019 Oct 29 2019 Nov 2019 Feb 2020 Mar 2020- April 2020 Jun 2020 July 2020 Aug 2020 Submi t protoc ol to PG coordi nator and PG office Asses sor group meeti ng Asses sor group meeti ng ` 26 Asses sor group meeti ng Submi t to Ethic group Data collect ion Data collect ion Data aanaly sis Repor t writing Repor t writing Submission to supervisor REFERENCES 1. World Health Organization: Global Report on Diabetes 2017. 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El Sharif N, Samara I, Awartani T, Awartani A. Compliance with and knowledge about diabetes guidelines among physicians and nurses in Palestine. EMJH 2015;21(11): 563-574 DOI: 10.26719/2015.21.11.791 25. Van Teijlingen ER, Hundley V. Importance of Pilot Studies.Social Research update 2001;35:1-5 http://hdl.handle.net/2164/157 Accessed 17 September 2019. http://hdl.handle.net/2164/157 DECLARATION ACKNOWLEDGEMENT DEDICATION LIST OF FIGURES LIST OF TABLES NOMENCLATURE INTRODUCTION METHODS AND DESIGN RESULTS: HbA1c: glycated haemoglobin test LDL: Low density lipoprotein HDL: High density lipoprotein DISCUSSION REFERENCES