Maritime Health Research and Education-NET/The International Type 2 Diabetes Mellitus and Hypertension Research Group/Revision of the ILO Guidelines for medical examinations of seafarers

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DRAFT 21 Jan 2022 PROPOSAL for Revision of the ILO Guidelines for medical examinations of seafarers to use early diagnosis of Type 2, Diabetes mellitus and hypertension using valid tests. (on request from International Maritime Health Asociation, Europeche and European Transport Workers)

Authors: International Type 2 Diabetes Mellitus and Hypertension Research Group A subgroup af MAHRE-Net https://en.wikiversity.org/wiki/Maritime_Health_Research_and_Education-NET

Commentaries are very welcome Contact: Agnes Flores 66595584 agnesflores230572@yahoo.com

Content Health-promotion data supplemental to the ‘fit-for-duty’ data 2 XII. Conducting medical examinations, pg18 2 Diabetes and hypertension prevention programs 4 Intervention in collaboration with shareholders 4 How to make accurate BLOOD PRESSURE measurements in the clinic? * 5 When should hypertensive seafarers be referred to hypertension clinics? * 5 When should a T2DM seafarer be referred to a specialist department? * 5 Self-hypertensive control on board and at home * 6 Self-management of diabetes on board and at home * 6 How to make accurate diagnosis of T2DM in the clinic* 6 References for pg 6-7 7 References for pg:2-6 8 APPENDIX F-1 Clinical Scientific Data Form * 9

The * marked sections need more explanation?

Please use “visible changes”

Thanks

� Part 3. Guidance to persons authorized by competent authorities to conduct medical examinations and to issue medical certificates p 21ff->

Citations from the “Guidelines”: in Italics Health-promotion data supplemental to the ‘fit-for-duty’ data This revision covers the Seafarers and the Fishers Guidelines for medical examinations(1)(2). The revision is based on the evidence for the low validity of the urine-stick test for the early diagnosis of type 2 diabetes (3)(4). The guidelines for seafarers’ medical examinations include health promotion beyond the fit-for-duty protocol, page: p.18 (iv), which is the core issue here: “The medical examination can be used to provide an opportunity to identify early disease or risk factors for subsequent illness. The seafarer can be advised on preventive measures or referred for further investigation or treatment in order to maximize their opportunities for continuing their career at sea” Our focus is on the early diagnosis and early implementation of T2DM health prevention to preserve good health in general and good eyesight, specifically, for the seafarers who are dependent on good vision to remain in their jobs for many years. The proposed health-promotion program focusing on T2DM and hypertension has an impact on all types of metabolic syndrome diseases and can help keep workers active for more years. The aim is to provide a foundation for the evidence base to foster safe and healthy preventive strategies and policies within the UN Global Sustainable Goals, especially Goal 3: Good health and well-being for all workers and Goal 8: Decent Work and Economic Growth(5). Effective health promotion, however, is dependent on research, which, in turn, depends on access to valid data. The centralization of data is needed for the research for health promotion regarding T2DM, hypertension and related metabolic syndrome diseases. In conclusion, Appendix F should be completed as before but supplemented by the Appendix F-1 Scientific Data Form for research purposes.

� XII. Conducting medical examinations, pg18

Unfortunately, the model for how to report laboratory data, especially in regard to urine-stick tests in Appendix F in the “Guidelines” has been misunderstood by maritime authorities as well as maritime doctors for many years. In the fit-for-duty guidelines, the national authorities have chosen to follow the example on page 51 (Appendix F) in the ‘Guidelines’ by asking for the results (glucose, protein, blood) based on urine dipstick analysis without mentioning the need for a supplemental HbA1C or similar high-validity test for the unbiased early diagnosis of T2D(1). Although urine dipsticks can be used to determine pathological changes in urine, they cannot serve as a valid diagnostic tool for T2D. Indeed, a review of studies on using urine dipsticks to test for T2D concluded that they should not be used due to their low sensitivity to detect T2D accurately, with the consequence of a high number of false negative tests (6). In one such study, the sensitivity of the urine dipstick to detect T2D correctly was 20.8% (95% CI: 8.1–52.8%), and a similar study from Sweden revealed a sensitivity of 18.1% versus the far higher sensitivities of fasting glucose and HbA1C (3,4). Neglecting to use valid tests for the early diagnosis of T2D internationally in the fit-for-duty tests over decennia may have increased the prevalence of major microvascular complications and quality-adjusted life-years (QALYs) as well as financial losses for workers, employers and states. Text to be corrected pg.20 (x) “The validity of any test used for the identification of a relevant medical condition will depend on the frequency with which the condition occurs. Use is a matter for national or local judgement, based on disease incidence and test validity” ‘The meaning of this text is unclear, and should be replaced by the following: “Sensitivity and specificity describe the accuracy of a test that reports the presence or absence of a condition. In a diagnostic test, sensitivity is a measure of how well a test can identify true positives”

Further to be added: The medical specialist in maritime medicine should pay particular attention to the fact that seafarers are vulnerable patients compared to most shore workers and may need to be referred to specialists in suspected cases of (pre-)hypertension and or (pre-)T2DM to be noted in the scientific data sheet (APPENDIX F-1) While the ‘Guidelines’ should be openly promoted, the data collection for research should be included as part of the medical health examinations, and the medical health examinations report should be divided into two parts:

1. APPENDIX F The maritime doctors complete the existing ‘fit-for-duty’ examinations and send their reports to the maritime authorities. 2. APPENDIX F-1 The maritime doctors complete the Clinical Findings Data Form and send it to the maritime authorities * The national maritime authorities are urged to make arrangements to transfer the digital data collected from APPENDIX F-1 in Excel format to the competent national occupational/maritime research institute for further analysis, reporting and publication. These data is without personal name, ID number or company identification, considered as “non-personal” under the General Data Protection Regulation (GDPR) and should not be acknowledged by the Ethical committees. Analysis of the epidemiological Prevalence data will allow for the identification of trends and comparisons between the countries etc. To estimate the real prevalence and prevalence rates we include all, regardless of their risk, such as obesity and their age. In Appendix F-1 is underscored that the authorities must give permission to run specific research projects with access to the needed data as example about the knowledge on the risk on Diabetes type-2 if the good advises are not followed.

Diabetes and hypertension prevention programs Simple lifestyle measures have been shown to be effective in preventing or delaying the onset of type 2 diabetes, hypertension and its complications: 1. Achieve and maintain healthy body weight 2. Physically active – doing at least 30 minutes of regular, moderate-intensity activity on most days. More activity is required for weight control 3. Eat a healthy diet, avoiding sugar and saturated fats; and 4. Avoid tobacco use – smoking increases the risk of diabetes and cardiovascular disease One test, HbA1c is sufficient to diagnose diabetes. A positive diagnosis can be made if the HbA1c level is ≥6.5% A case of positive diagnosis should be confirmed with a repeat HbA1c test and/or plasma glucose. A case of positive diagnosis should be confirmed with a repeat HbA1c test and/or plasma glucose American Diabetes Association [1]Danish Endocrinological Society

Intervention in collaboration with shareholders

The success of the personal struggles depends however, on supportive environments, established by the shareholders with the needed conditions for good health practices for persons with diabetes, hypertension and all others with risk for chronic metabolic diseases. The shareholders are prompted to establish the specific conditions at work that are needed for seafarers to maintain good health practices, especially for employees with type 2 diabetes and hypertension in different types of jobs. The shareholders are challenged to maintain a stable and supportive health environment for fishers and seafarers who work up to 12 hours per day over several months away from shore. A supportive environment includes opportunities during workdays for time and allowance for relevant work breaks, restroom visits, access to nutritious meals in good social company, time off and possibilities for adequate physical activity. The necessary conditions are different in various job groups, and an analysis of these conditions and suggestions for how they can be made optimal is needed. Implementations for adequate structural changes in workplaces, sufficient time for meal breaks and restroom visits, cooks who prepare healthful lunches, a fitness room and other relevant installations should be considered imperative. Among the important shareholders are also the authorities to give permission to run specific research projects with access to the needed data as example about the knowledge on the risk on Diabetes type-2 if the good advises are not followed. The cosrt-benefit has to be calculated.

How to make accurate Blood pressure measurements in the clinic? *

For the accurate diagnosis and management of Blood pressure, proper methods are recommended for the accurate measurement and documentation of BP (9)……. When should hypertensive seafarers be referred to hypertension clinics? *

Compared to shore workers, seafarers are socially vulnerable hypertension patients with a need for special attention and may need to be referred to a hypertension clinic (10), (11). A referral can also be relevant for providing instructions for self-hypertensive control on board and at home…. When should a T2DM seafarer be referred to a specialist department? *

Transport workers like seafarers and truck, bus, train, and taxi drivers as well as fishers are known to have significant inequities regarding their health at work, including a high risk of developing type 2 diabetes. Compared to shore workers, seafarers are socially vulnerable type 2 diabetes patients with a need for special attention, as described by Rogvi et al. (12). Self-hypertensive control on board and at home *

Self-monitoring of with Type 2 diabetes is necessary to monitor self-management. Instructions and the relevant equipment in the medical cabinet on board is required. In addition, courses are needed as well as revisions to the International Medical Guide for Ships (check ships’ medical Chest) (13). Self-management of diabetes on board and at home *

Self-monitoring of blood glucose for non-insulin-treated adults with Type 2 diabetes is necessary. Instructions and relevant equipment in the medical chest on board are needed and have been added to the actual revision of the International Medical Guide for Ships (14). (please add more information)

How to make accurate diagnosis of T2DM in the clinic (and costs)*

Urinary glucose has been widely used as a screening tool for diabetes being non-invasive and easy to perform. The renal threshold for glucose (approximately 10 mmol/l) corresponds well to a relevant screening level for postprandial hyperglycemia[1]. However, the method is unable to pick up elevated fasting- and preprandial hyperglycemia below this threshold, and while it reflects an average level of blood glucose since last voiding, it cannot reflect chronic hyperglycemia. Furthermore, under- or overestimation is seen in conditions with high- (long diabetes duration or kidney failure) or low- (pregnancy, children, MODY diabetes?) renal glucose thresholds[2,3]. Finally, fluid intake may influence urine concentration and thus glycosuria test results. Since 2011, Glycolated Hemoglobin (HbA1c) has been used to diagnose diabetes in most countries and replaced blood glucose performed in the fasting state or 2 hours after and oral glucose tolerance test[4]. A confirmed HbA1c concentration ≥ 48 mmol/mol defines diabetes. The use of HbA1c was made possible after establishment of a reference measurement procedure for international standardization of routine HbA1c assays[5]. There were several reasons for this recommendation. HbA1c was already used in clinical practice for decision making on antidiabetic treatment. Compared to glucose measures, HbA1c is stronger associated with most long-term micro- and macrovascular diabetes complications[4]. Measurement variability is negligible (~1%) compared to blood glucose (12-15%)[6]. HbA1c does not require fasting and is obviously less time consuming than the cumbersome oral glucose tolerance test. In some cases, a blood glucose measure may be a relevant alternative to the HbA1c, primarily in conditions where HbA1c does not fully reflect glucose levels, such as severe anemia, kidney failure, or in persons with hemoglobinopathies[7]. Importantly, for low income countries, HbA1c is a rather expensive measure, and not possible to apply to the general diabetes population[8]. References for pg 6-7 [1] Goldstein DE, Little RR, Lorenz RA, Malone JI, Nathan D, Peterson CM, Sacks DB. (Meador et al., 2020) Diabetes Care. 2004 Jul;27(7):1761-73. doi: 10.2337/diacare.27.7.1761.

[2] Alto WA. No need for glycosuria/proteinuria screen in pregnant women. J Fam Pract 2005;54:978

[3] Menzel R, Kaisaki PJ, Rjasanowski I, Heinke P, Kerner W, Menzel S. A low renal threshold for glucose in diabetic patients with a mutation in the hepatocyte nuclear factor-1alpha (HNF-1alpha) gene. Diabet Med. 1998 Oct;15(10):816-20.

[4] The International Expert Committee. International Expert Committee Report on the Role of the A1C Assay in the Diagnosis of Diabetes. Diabetes Care 2009 Jul; 32(7): 1327-1334.

[5] Consensus Committee. Consensus statement on the worldwide standardization of the hemoglobin A1C measurement: American Diabetes Association, European Association for the Study of Diabetes, International Federation of Clinical Chemistry and Laboratory Medicine, and the International Diabetes Federation. Diabetes Care. 2007;30: 2399-2400.

[6] Ollerton RL, Playle R, Ahmed K, Dunstan FD, Luzio SD, Owens DR. Day-to-day variability of fasting plasma glucose in newly diagnosed type 2 diabetic subjects. Diabetes Care 1999; 22: 394– 398

[7] Borg R, Persson F, Siersma V, Lind B, de Fine Olivarius N, Andersen CL. Interpretation of HbA1c in primary care and potential influence of anaemia and chronic kidney disease: an analysis from the Copenhagen Primary Care Laboratory (CopLab) Database. Diabet Med. 2018 Jul 9. DOI:10.1111/dme.13776.

[8] WHO 2011. Use of Glycated Haemoglobin (HbA1c) in the Diagnosis of Diabetes Mellitus. https://www.who.int/diabetes/publications/report-hba1c_2011.pdf �References for pg:2-6

1. Guidelines on the medical health examinaitona for seafarers wcms_174794-kopi.pdf. 2. Guidelines on the medical examinations of fishermen - Buscar con Google [Internet]. [cited 2022 Jan 7]. Available from: https://www.google.com/search?q=Guidelines+on+the+medical+examinations+of+fishermen&rlz=1C5CHFA_enPA874PA874&sxsrf=AOaemvKFEsiZLRCNpAv-PaqDF-ZAezvKew%3A1641567851725&ei=a1bYYeHnK4OKwbkPrPKoiAs&ved=0ahUKEwihybTl9J_1AhUDRTABHSw5CrEQ4dUDCA4&uact=5&oq=Guidelines+on+the+medical+examinations+of+fishermen&gs_lcp=Cgdnd3Mtd2l6EAMyBQghEKABOgQIIxAnOgYIIxAnEBM6BQguEMsBOggIIRAWEB0QHjoHCCEQChCgAUoECEEYAEoECEYYAFAAWMwnYMY0aABwAHgAgAHRAYgB9wuSAQUwLjkuMZgBAKABAcABAQ&sclient=gws-wiz 3. Jensen OC, Flores A, Corman V, Canals ML, Lucas D, Denisenko I, et al. Early diagnosis of T2DM using high sensitive tests in the mandatory medical examinations for fishers, seafarers and other transport workers. Prim Care Diabetes [Internet]. 2022 Jan 4 [cited 2022 Jan 7]; Available from: https://www.sciencedirect.com/science/article/pii/S1751991821002345 4. Jensen OC et al. Submitted Letter to Editor Diabetes Research and Clinical Practice Rethinking the use of urine dipstick for the early diagnosis of Type 2 Diabetes.pdf. 5. THE 17 GOALS | Sustainable Development [Internet]. [cited 2022 Jan 18]. Available from: https://sdgs.un.org/goals 6. Wei OY, Teece S. Urine dipsticks in screening for diabetes mellitus. Emerg Med J EMJ. 2006 Feb;23(2):138. 7. Friderichsen B, Maunsbach M. Glycosuric tests should not be employed in population screenings for NIDDM. J Public Health Med. 1997 Mar;19(1):55–60. 8. Andersson DKG, Lundblad E, Svärdsudd K. A model for early diagnosis of type 2 diabetes mellitus in primary health care. Diabet Med. 1993;10(2):167–73. 9. Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, et al. 2020 International Society of Hypertension Global Hypertension Practice Guidelines. Hypertension. 2020 Jun 1;75(6):1334–57. 10. Kennedy C, Farnan R, Stinson J, Hall M, Hemeryck L, O’Connor P, et al. Referrals to, and characteristics of patients attending a specialist hypertension clinic. J Hum Hypertens. 2021 Mar 8; 11. Meador M, Lewis JH, Bay RC, Wall HK, Jackson C. Who Are the Undiagnosed? Disparities in Hypertension Diagnoses in Vulnerable Populations. Fam Community Health. 2020 Jan;43(1):35–45. 12. Rogvi SÁ, Guassora AD, Wind G, Tvistholm N, Jansen SM-B, Hansen IB, et al. Adjusting health care: practicing care for socially vulnerable type 2 diabetes patients. BMC Health Serv Res. 2021 Sep 10;21(1):949. 13. Shimbo D, Artinian NT, Basile JN, Krakoff LR, Margolis KL, Rakotz MK, et al. Self-Measured Blood Pressure Monitoring at Home: A Joint Policy Statement From the American Heart Association and American Medical Association. Circulation. 2020 Jul 28;142(4):e42–63. 14. Tanenbaum ML, Leventhal H, Breland JY, Yu J, Walker EA, Gonzalez JS. Successful self-management among non-insulin-treated adults with Type 2 diabetes: a self-regulation perspective. Diabet Med J Br Diabet Assoc. 2015 Nov;32(11):1504–12.

� APPENDIX F-1 Clinical Scientific Data Form (New proposed)

Lab. data registration scheme

Inform Cons (1) Age Gend Natio (2) Fisher Seaf Waist cm Dia BLOOD PRESSURE Sys BLOOD PRESSURE A1C (3)

FSG

Hight

cm Weight Kg

Doyou have Diab? (4) Do you have Hypert? (4) Take any Medi-cine?(5) ref to DM spec ref to Hyp spec

(1) Ask the seafarer/fisherman if we can use anonyme data for research (2) Own country= 1, Other = 2  (3) Variable with decimals in Excel in "Standard" use commas"," not in "." (4) Copy the answer from interview scheme (5) Metformine = 1 other = 2

Diagnostic registration scheme

 DIABETES TYPE 2   HbA1c Fasting Glucose   Value Measurement today: ->       Mark Preliminary Diagnosis     Normal   ≤ 5,6% ≤ 100 mg/dl Prediabetes   5.7-6.4% 100 -125 mg/dl Diabetes   ≥ 6,5% ≥126 mg/dl Diabetes (=taking anti-DM)      

 HYPERTENSION (HTN)   Diastolic Systolic   Value Measurement today: ->       Mark preliminary diagnosis     Normal   80 130 Prehypertension   80-89 130-139 Hypertension Stage 1   90-99 140-159 Hypertension Stage 2   100+ 160+ HTN=anti-hypertensive med.      

Add age for research (not only day, month, year of birth) Add value for fasting glucose FSG (not only y/n normal) (Fasting glucose or HbA1c) Inform seafarer whether is non-diabetic, pre-diabetec or diabetic give advice and refer to specialist, if needed Inform seafarer whether: non-hypertensive/pre-hypertensive/ hypertensive (see definitions), give advice and refer to hypertensive specialist if needed. Use standardised reporting for research purposes, send data to designated international researcher contact (MAHRE-Net – ocj@health.sdu.dk)

1. Urine dipstick method should be replaced by Glycosylated Hemoglobin Test (A1c) and/or fasting blood sugar
2. Early diagnostics of T2DM via routine medical exams
3. Early diagnostics of Hypertension via routine medical exams

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References