background to projectcsusap.csu.edu.au/~hjelinek/discri documents/discri staff... · web viewearly...

Contents

Page

Background to Project 4Screening and intervention opportunity: an example for metabolic syndrome 4

Diabetes and Cardiovascular Disease: Relationship to this Project 6Health impacts of diabetes and its complications 6Diabetic Retinopathy

6Cardiovascular Disease

7Foot complications

7Quality of life and health care 8

Impact of Early Intervention on Quality of Life for People with Diabetes Complications

8Assessment intervention strategies in rural/regional areas 9

Barriers to effective screening and treatment

9Strategies in assessment of complications of diabetes 10

Eye Screening 10Heart Assessment

10Foot Assessment

11A one-stop mobile health check for diabetes 12References 13Risk Management Plan 16

Diabetes Complications Screening and Research

17Standard Operating Procedures (SOP) 32

Venipuncture Technique Using the Multisample Vacutainer System

33Blood Collection by Finger Prick 37

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Manual Blood Pressure Measurement 38Body Mass Index (BMI)

42Use of Tiptherm ™

43Autonomic Nervous System Function Tests (Ewing Battery) 443-lead Electrocardiogram (ECG)4612-lead Electrocardiogram (ECG)49

Risk Assessments 54Venipuncture 55Electrocardiogram (ECG)56Blood Pressure Recording using a Sphygmomanometer and Stethoscope 57Blood Pressure Recording using a Digital Blood Pressure Monitor 58

Emergency Procedures 59Cedar Floor Plan

60Diabetes Complications Screening Emergency Response 61Hypoglycaemia Emergency Response

62Fainting Emergency Response 63

Student Screening Documents 64Student Acknowledgement Statement 65Student feedback for diabetes complications screening 66

Diabetes Complications Screening Forms 67Information Sheet

68Consent Form 70Participants Information

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Participants Assessment Results Feedback

73To: General Practitioner 73

Diabetes Screening Session - Stations.

75Station Requirements:

76Pathology Request Forms 77

Dorovitch Release Form78

South West Pathology Release Form 79

Insurance 80ECG Analysis 81

12-lead ECG classification 82Analysing HR Intervals with Chart 5 83Downloading Files from Mac Computers 84

Retinal Analysis 85Digital Health Care Software and Camera Loading on to PC

85Non- Mydriatic Camera

86Saving Digital Eye Data as JPG Files 87


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Background to Project

Diabetes mellitus is a growing health care problem in Australia with over two million Australians expected to be diagnosed with diabetes by 2010. This equates to roughly 10% of the population and increases the work-load on general practitioners. Cardiovascular disease (CVD) remains the most important complication of diabetes. The annual macrovascular event rate in the absence of risk factors for CVD (such as dyslipidemia, hypertension, smoking, and obesity) is 2%. In the presence of a risk factor, this increases to 5%, and if there is a history of a macrovascular event, the rate rises to 8%. In select populations with low high-density lipoprotein cholesterol (HDL-C), the rate can be as high as 11% per year.

Cardiovascular associated mortality accounts for 38% of all deaths. 16.4% of Australians currently have CVD. Independent of diabetes, CVD will affect one in four Australians by 2051. CVD associated mortality accounts for 38% of all deaths. 16.4% of Australians currently have CVD.

Of immediate concern is also the recognition that a constellation of symptoms, the metabolic syndrome constitutes an increased risk of diabetes and cardiovascular disease.

Screening and intervention opportunity: an example for metabolic syndrome

Outlined here is a summary of metabolic syndrome that highlights presentation and screening requirements. Of interest here is that the identification of people with metabolic syndrome can be part of a chronic disease management and intervention programme at CSU with the possibility of various student cohorts including nursing, podiatry, pharmacy, nutrition, physiotherapy/exercise physiology, occupational therapy and leisure and health as well as medical imaging involved in screening and intervention. Many of these student cohorts can be part of the screening and intervention through placement at the university on any of the campuses or via tutorials, practical classes or workshops. This provides multidisciplinary health care to all regions serviced by the Faculty and also reduces the cost of placements that are incurred by some disciplines.

As such NSW Health, various publications from the Australian Diabetes Society and Australian Heart Foundation and the American Diabetes Association (ADA) have suggested that the reduction of macrovascular disease risk such as seen with metabolic syndrome (Table 1) requires a multifactorial approach that addresses all risk factors, including obesity and hypertension, in addition to dyslipidaemia, and makes the following recommendations.

Table 1: Factors associated with metabolic syndromeMetabolic syndrome is defined if three of the listed features are present

Abdominal obesity (waist > 101 cm in men or > 89 cm in women); Elevated triglycerides (> 8 mmol/L); Decreased HDL-C (< 2 mmol/L in men and < 3 mmol/L in women); Hypertension (blood pressure > 130/85 mm Hg); and Elevated fasting blood glucose (> 6 mg/dL).


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Individuals who present with 3 or more of these features are at elevated risk for developing CVD. These features can be determined by the chronic disease management clinic by including point-of-care testing for cholesterol unless a result is available through the general practitioner or pathology service.

The recommended strategy for managing patients with the metabolic syndrome is to reduce underlying causes (ie, obesity and physical inactivity) and to treat nonlipid and lipid risk factors. Again apart from medication management, the chronic disease management clinic can contribute meaningful intervention and health care.

I list some additional relevant screening and intervention possibilities below:

Identification of CV risk factors such as hypertension, obesity, smoking and alcohol as well as age, family history and blood sugar levels

Diabetes and diabetes risk factor – increased blood sugar levels, age, ethnic background, family history, gestational diabetes and ovarian cancer

Lifestyle counselling - Smoking abstinence, exercise, weight control, blood pressure control and diet as well as medication review.

Medical imaging is also relevant to this as it can be used to identify asymptomatic cardiovascular disease and confirm 12-lead or 3-lead ECG assessment.

Pharmacy medication review Nutrition counselling Nursing reviews Occupational Therapy – quality of life and activities of daily living Physiotherapy - exercise


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Diabetes and Cardiovascular Disease: Relationship to this Project

Given the increased incidence of diabetes nationally and internationally over the last 2 decades, a vast amount of literature in the area has been generated. The review below addresses the literature sets relating to this project namely: health impacts of diabetes and its complications; assessment intervention strategies in rural/regional areas; and, the experience of people and their families living with diabetes in rural regional communities.

Health impacts of diabetes and its complications In 2002, an estimated 780,000 Australians had diabetes, with numbers exceeding one million by 2010.[1] This reflects approximately 5% of the population. In Aboriginal and Torres Strait Islander communities this percentage may be projected to be approximately 13%.[2] The onset of Type 2 diabetes has been reported to occur 9 to 12 years before clinical diagnosis and thus complications of diabetes are often severe and when identified, often the first indication of the presence of diabetes.[3] The early detection of undiagnosed diabetes is a key intervention point in reducing the associated personal and community burden. Both national and state governments acknowledge the disadvantage faced by rural people in availing themselves of all aspects of diabetes management, from screening to regular assessment, education and health care.[1]

Regular screening for complications of diabetes including vision, heart and foot complications provides an opportunity to identify more of the people with unidentified diabetes and provide early appropriate health care to these and people with eye, heart and foot complications. Extrapolation from data obtained from eye health initiatives, indicates that interventions that relieve or prevent complications associated with diabetes are highly cost effective.[4]

Diabetic Retinopathy

Retinopathy is asymptomatic in the early stage. Up to 20% of people with non-insulin dependent diabetes mellitus (NIDDM) have retinopathy at the time of diagnosis (Harris et al 92). Diabetes in indigenous Australians is 2-5 times the national average and as a group Australian Aborigines suffer the fourth highest rate of NIDDM in the world.[5] Treatment to prevent blindness is very effective provided the retinopathy is detected early.[6,7] However, of people who know that they have diabetes, only 35% have regular eye checks in Victoria.[4] This figure is somewhat higher in N.S.W. at 55%.[8] Several programs are being discussed nationally to improve the screening percentages for diabetic retinopathy with national figures aimed at 80%.[9] Working towards an increased awareness in the community is one part of the solution, the other is to incorporate additional models for diabetic retinopathy screening that complement currently existing eye-care service.[4,10]Diabetic retinopathy (DR) could be significantly reduced by simplifying the procedure used to diagnose the condition and ensuring that early eye examinations become routine for diabetic patients, according to an advisory group convened by JDRF.[11] Rural screening is difficult because of health care barriers such as geographical isolation, the cost of visits to specialists and the lack of ophthalmologists available. [12-14]


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Cardiovascular Disease

Cardiovascular disease, affecting the larger blood vessels is a major complication of diabetes. People with diabetes are two to four times more likely to develop cardiovascular disease and their prognosis is not as good. Diseases of the circulatory system such as coronary heart disease and stroke were listed as the underlying cause of death in 55.7% of deaths in 2000 where diabetes was an associated cause.[5] In addition some form of nervous system damage that affects the function of the heart and blood vessels, occurs in up to 60-70% of people with diabetes.[15] Regular screening and early recognition of nervous system damage affecting cardiac function in people with diabetes allows better treatment intervention and reduces the number of deaths associated with diabetes related cardiovascular disease.[16]

Foot complications

In the Western world diabetic foot problems have been reported as the most common complications of diabetes. Diabetic foot problems are associated with nerve damage (diabetic neuropathy) and poor circulation (peripheral vascular disease) in the lower limbs.[17] These factors increase the risk of foot ulcers, infection and lead ultimately to lower extremity amputation. Among people with diabetes, 19.4% were found to be at risk for foot ulcers and 2.1% reported absence of limbs. Peripheral neuropathy and peripheral vascular disease were reported in 24.2% and 12.6% respectively. Regular monitoring of the feet for early signs of diabetic neuropathy, peripheral vascular disease and foot deformities reduces the risk of serious foot ulcers and amputation. An important adjunct to reducing the percentage of amputations is to have appropriate assessment methods for recognising vascular disease.[18, 19]


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Quality of life and health care

Few studies have assessed the influence of social environment on health, but increasing attention.[20] For effective health care public health workers involved in diabetes prevention and control in all communities including ethnic and Aboriginal and Torres Strait Islander communities. Health care professionals need to listen and engage with people articulating their experiences of health and illness within the social, political, economic, as well as biological context of their lives.[20] Communities within which public health workers are now working are often not stable, connected and demographically as well as culturally similar populations living within a traceable geographical location. This insight becomes especially important for communities with increased incidence of diabetes and risk behaviour. Assessing individuals in diverse communities effectively increases the quality of life of individuals and the overall health of the community.

Impact of Early Intervention on Quality of Life for People with Diabetes Complications

Quality of life is a term used in a number of disciplines, and definitions and conceptualizations vary from utility of health states to life satisfaction and from possession of socially desirable characteristics to positive affect. In order to address the quality of life issues associated with the disproportionately high rates of diabetes and poor medical service provision in rural and remote regions of Australia, alternative models of primary health care have to be considered.[7] There is considerable variation in diabetes management in different primary care settings even in the same hospital. [21] The main difference was in consistent and appropriate screening for risk factors and complications in people attending the clinics. Screening for diabetes has the potential to be an effective intervention, especially if patients have intensive treatment of their newly diagnosed diabetes. In a recent study the effectiveness of a home-based cardiac rehabilitation program in improving health outcomes and rehabilitation access for special-needs patients has shown that significant positive changes for measures of quality of life, knowledge of angina, and exercise tolerance. Additionally, higher levels of participation and completion were also noted.[22]

Outcomes research is used increasingly for assessing the health outcome benefits of new therapeutic programs and interventions. Therefore measures of quality of life have to consider gains in health outcomes and programs in diabetes.[23] To achieve uniform care for all people with diabetes a on-stop assessment unit that makes the primary health care team accessible to all, provides effective management of risks for diabetic patients by advice, education, and therapeutic modification is the starting point to address quality of life issues associated with diabetes.


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Assessment intervention strategies in rural/regional areas

Complications associated with diabetes remain often undetected for quite some time especially in rural regions, but in a twist are often health problems that alert health care providers to the presence of diabetes.[24] Government agencies as well as specialist groups such as the Australian Diabetes Association advocate that routine screening of persons at risk of diabetes allows earlier detection of the disease and better health outcomes. Diabetes is a disease that is amenable to screening as the disease is common, serious, and has a long asymptomatic phase. In addition acceptable tests exist for identification of the disease and treatment must matter during the asymptomatic phase (World Health Organisation Guidelines). The Australian Diabetes Association recommends screening after 45 years of age and to be repeated every 3 years. However if hypertension, cardiovascular disease, increased lipid levels, physical inactivity, gestational diabetes and obesity are present, earlier and more frequent screening is required. This is also the case if the person is of pacific island or indigenous origin. At a recent primary telemedicine conference, Balsbaugh has reported that universal screening is feasible and cost effective, it delays complications and younger patients have a longer time to benefit from early identification.[25]

Barriers to effective screening and treatment

Barriers and strategies for general delivery of diabetes care in primary health care include the lack of specialists in rural communities and often the cost of equipment required for assessment.[1,26] Rural and remote areas experience relative deficits in supply of allied health professionals in addition to relative deficits in the medical workforce. Despite considerable policy focus on rural and regional health services geographic imbalances in the primary health workforce supply levels persist. Further barriers are geographical separation of health care providers, impaired communication and collaboration of providers, impaired access to services and patient passivity and poor compliance. Any of these will impact on activity levels and quality of life for people with complications associated with diabetes.[27]

Barriers hindering optimal diabetes care delivery can be overcome by specific strategies.[26] Ideally, the services are co-located and synchronised in a one-stop-shop. Our mobile unit addresses several of the barriers such as providing co-located services, a central data collection system that is online for access by health professionals that require information for follow-up and by use of computer based assessment of possible vision and heart anomalies requires less specialist input in routine screening.


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Strategies in assessment of complications of diabetes

Vision loss, cardiovascular disease and foot amputations are the most often occurring outcomes of diabetes. Damage to the eye associated with diabetes (diabetic retinopathy) is the commonest cause of blindness in the working age population in developed countries. Yet 98% of people with vision loss can be treated effectively provided the pathology is detected early. Cardiovascular complications associated with diabetes and on it’s own is the commonest cause of death in the population.[24] Early detection of blood vessel changes associated with retinopathy, cardiovascular disease and foot complications is important for timely treatment to prevent or delay the occurrence of these complications and improve the quality of life for individuals with diabetes.[13,28] Regular health screening that includes eye, heart and foot assessment has the potential to reduce the high costs on the health care system and reduces the disparity in health care between rural and urban communities by providing timely feedback to those at risk.[29]

Eye ScreeningAutomating the assessment changes in the retina can be carried out using mathematical techniques such as developed by our team and others.[30-32] These mathematical techniques can be applied to the estimation of blood vessel diameter changes and quantify the appearance of microaneurysms and haemorrhages as well as new vessel growth in the advanced stages of diabetes. Identification of the number of microaneurysms is positively correlated with diabetes. [33,34] Of interest has been the correlation between blood vessel diameter changes in the eye that is not only associated with diabetes but is also an early indicator for cardiovascular disease and stroke.[13]

Heart AssessmentElectrocardiology is still regarded as the most commonly used procedure for the assessment of cardiac function and identification of heart disease, utilized by numerous health care practitioners including community health nurses. We have investigated the efficacy of 3-lead ECG assessment in community health with good outcomes suggesting a cost benefit and improvement in health care.[35] We have also developed an ECG classification protocol for community screening using 12-lead ECG that optimizes referrals to general practice by reducing the number incorrectly referred through community screening.[36]

ECG interpretation, although mostly automated is usually carried out by a specialist, be that a cardiac nurse, general practitioner or cardiologist. The Charles Sturt Diabetes Complications Screening Programme has investigated the possibility of primary health care providers assessing heart function using an automated ECG assessment tool that differs to the traditional method by evaluating the heart rate variability obtained using a 3-lead recording. Our recording and interpretation tool adds two important features to heart assessment. 1) it allows primary health care providers to record ECGs (placing 3-lead ECGs is less complex compared to placing a 12-lead ECG and less invasive in community health settings) and 2) identify asymptomatic changes in heart function associated with diabetes.[37] Our method is based on observations that many cardiac anomalies, including diabetic autonomic neuropathy, change the heart rate variability before any overt ECG anomalies are detectable.[38,39] However, whereas cardiologists with current methods can not pick up preclinical cardiac anomalies our method has the potential to do this. [40] In


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addition relatively short 3-lead ECG recordings can be used in evidence based health care and accountability for primary health care practice with lead II recordings showing a similar efficacy in identifying at risk individuals as 12-lead ECG recordings.[41]

Foot AssessmentRegular monitoring of the feet for early signs of diabetic neuropathy, peripheral vascular disease and foot deformities are essential.[5] Measurement of sensory impairment using monofilament tests to identify peripheral neuropathy, ankle-brachial index to identify peripheral vascular disease and observation of skin lesions and range of motion changes at the ankles are direct and simple yet reduce the risk of serious foot ulcers and amputation.[42] These measures provide an indicator for further assessment if required by specialists using more sophisticated assessment procedures.[43] Charles Sturt University has been assessing foot health as part of its Allied Health Clinic and this knowledge can be incorporated into the mobile assessment unit. [18]


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A one-stop mobile health check for diabetesIncidence percentages stated above increase in the elderly, are higher in indigenous and Torres Straight Islanders and in high-risk people such as those with a sibling having diabetes or obesity. The impetus to establish a one-stop mobile health check for diabetes stems from reported barriers to effective health care for people with diabetes, similar studies undertaken in Australia for screening of eye complications and our own findings in the Border region.[10] The UK National Service Framework for diabetes has also clearly indicated that the modes of managing diabetes by offering regular easy-to-access diabetes care and assessment improves health outcomes.[43] Anecdotes from participants at the Albury-Wodonga diabetes complications screening has indicated that a one-stop screening facility is preferred by the public that includes high risk individuals and people with diabetes.[14] At the Border the diabetes complications screening group has carried out cardiovascular complications screening at Tallangatta, a rural township and Albury/Wodonga with good attendance. Considering cardiovascular complications in diabetes account for 65% of all diabetic deaths, automated screening procedures developed at Charles Sturt University and used at Tallangatta and Albury/Wodonga to identify asymptomatic changes in heart function associated with heart rate variability demonstrated the utility of these procedures. The results indicate that automated screening for heart pathology has the potential to reduce cardiac morbidity through the early identification of autonomic nervous system changes in people with diabetes and identifying serious ECG anomalies.[37,39] Cree et al. (2002) have tested their automated procedures for identification of asymptomatic changes in the eye associated with diabetic retinopathy.[34] In collaboration with Leandro et al. (2003), the Charles Sturt University diabetes complications assessment group have verified that these automated procedures can be used for community screening.[29,44] Combining the automated eye and heart assessment, with podiatric assessment of peripheral vascular and nervous system dysfunction and on-the-spot biochemical checks for sugar, HbA1c and creatine levels delivers a complete health care provision when combined with appropriate follow-up, education to improve the quality of life of people with diabetes.[45,46]


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References


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Risk Management Plan


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Form 36:Risk Management Plan

Version: 1.1May 2006

Next Review:May 2008


The aim of this Risk Management Plan is to identify major risks in the Diabetes Complications Screening and Research and to analyse and manage them effectively.

This plan is intended to supplement relevant legislation, regulations and guidelines. Students and researchers participating in the screening and research must maintain good research practice, have knowledge of human research ethics (including privacy) and intellectual property management, have an understanding of OH&S and be appropriately trained in all procedures they undertake.

This document must be approved by the Head of School before any work is undertaken. Attachments are attached and indicated in the appropriate place.

1. Project Title: Diabetes complications screening and research

2. Project Type: Staff Research, Postgraduate, Clinical Placement and Tutorial

3. Outline of Proposed Procedures Note: SOPs attached for all above procedures

Blood collection by finger prick - assessment of random or fasting blood glucose Blood collection by venepuncture – range of biochemical tests Foot sensation tests – assessment of nervous system function Blood Pressure (BP) Recordings –ankle brachial index (ABI), and lying to standing BP Calculation of BMI - Height, weight & waist circumference measurements Eye test – Photograph of the retina of the eye using a non-mydriatic camera ECG - normal 12 lead ECG recording ECG - 3 Lead ECG recording (2o minute) for heart rate variability Autonomic nervous system (ANS) function tests – controlled breathing, handgrip, BP

monitoring, valsalva manoeuvre 4. Participants

Coordinator: Dr H JelinekSupervisors: Herbert Jelinek, Paul Tinley, Paul Warner Operators: Herbert Jelinek, Paul Tinley, Harriet Farquhar, Paul Warner, Bev deJong, Cherryl Kolbe, Uba NwoseOthers (outside School): 2nd / 3rd year nursing students and 4th year podiatry students


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5. Location: Rooms 119 and 126, The Cedar building, Olive Street, Albury NSW 2640

6. Expected Duration: From 26 July 2006 ongoing fortnightly screening7. Identified Risks

Safety & Environment Hazardous substances Infectious agents Portable electrical equipment, power boards & extension leads Biological waste

Occupational Health Stress

Accident conditions Slips, trips and falls Participant fainting Participant experiencing a hypoglycaemic event Participant experiencing a cardiac event Patient experiencing an epileptic fit Failure to identify & follow up an abnormal test result Failure to monitor participants effectively Failure to oversee emergency procedures

Values, ethics and reputation Serious breach of protocol or ethics committee requirements Serious breach of confidentiality

Data quality and management Fraud in collection of data Serious errors in analysis of data Loss of data due to inadequate Data back-up procedures

Business Continuity

Finance Insurance

Compliance

Student experience

Other


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8. Equipment Required – See attached SOPs Non-mydriatic camera ECG recording equipment Standard blood collection equipment All other equipment as standard use in Allied Health Clinic.

9. Personnel Data (list ALL persons involved in the project)Name Title Training and Experience in this type of Operation

Herbert Jelinek Dr use of non-mydriatic camera, ECG, foot sensation tests, ABI, ANS function tests, BP recordings, BMI

Paul Tinley Dr ABI, foot sensation testsPaul Warner Mr ECG, venipuncture, finger prick

Bev deJong Ms Finger prick, use of non-mydriatic camera, ECG, foot sensation tests, ABI, ANS function tests, BP

Cherryl Kolbe Ms Venipuncture, finger prick, use of non-mydriatic camera, ECG, foot sensation tests, ABI, ANS function

Students as listed in attachment

Note: All CSU staff listed above have been appropriately trained in these procedures as

outlined in the attached training register. See table 1 for risk assessments

10. Conclusions of the risk assessment All identified risks require strategies to reduce the likelihood of occurrence. It is not practical to eliminate any of the risks by disallowing the activities.

The risk assessment and risk management plan is shown in Table 1.

11. Risk management Any risks associated with the Diabetes Complications Screening and Research can be managed by setting a standard for research activities and by developing good research practice by all researchers and ensuring researchers are suitably trained in all procedures.

12. Monitoring and review The Risk Management Plan for the Diabetes Complications Screening and Research will be distributed to all researchers involved. Responsibility for monitoring and review rests with the Coordinator Dr H. Jelinek.


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13. Signed (ALL persons involved in the project)

Names: Signatures:

Herbert Jelinek

Paul Tinley

Paul Warner

Bev deJong

Cherryl Kolbe

14. Supervisor’s Approval and Comments................................................................

Name: ..............................................................................................................................................................................................................................................................................Signed .................................................................................. Date ..........................

15. Head of School's Approval and Comments.....................................................................................................................................................................................................................................................................................................................................................................................................................Signed .................................................................................. Date ..........................


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Identification of risks The risks identified in this document are those recognized to date, however, further risks may be identified in the future and will be added to later versions of this document. The potential risks identified relate to:

Safety & Environment Occupational Health Accident conditions

o Failure to monitor participants effectively or oversee emergency procedures leading to serious injury or death of a participant

Values, ethics and reputation

o Serious breach of protocol or ethics committee requirementso Serious breach of confidentialityo Human ethics

Data quality and management o Fraud in collection of datao Serious errors in analysis of data o Loss of data due to inadequate back-up procedures

Business Continuity Finance

o Insurance Compliance Student experience

Risk analysis This risk analysis was carried out according to the AS/NZS 4360:2004 Risk Management and Charles Sturt University’s risk management Strategic Framework 2005.

The likelihood of occurrence of each event was rated on a scale A-E.

Score Descriptor Likelihood RatingA Almost certain Could happen at any timeB Likely Could happen sometimeC Possible Could happen, but very rarelyD Unlikely Could happen, but probably never willE Rare Could happen, but only in exceptional circumstances

The consequences were also ranked in degree of severity on a scale of 1-5.

Ranking Degree of Severity

Detail Description

1 Insignificant Complaints that can be dealt with routinely Financial loss that comes within the relevant financial delegation level Political enquiries resolved by routine management procedures The consequences are dealt with by routine operations

2 Minor Minor health impairments to patients and researchers Threaten the efficiency or effectiveness of some aspects of the School Financial loss that would impact on the research group Complaints that can be dealt with internally

3 Moderate Unexpected/unplanned health impairments to patients and/or researchers Be serious for the Program/School either financially or politically Result in need for study to be repeated at considerable cost and effort Result in irreversible loss of essential data; may require considerable time

and expenditure to reconstruct database Would not threaten survival of the program, but could be subject to

significant review or changed way of operating Result in negation of the study data with results being unreportable and

unpublishable Result in necessity to notify ethics committee Adverse media coverage Lead to significant legal action against researchers and CSU


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http://www.csu.edu.au/division/healsafe/

http://www.saiglobal.com/online/autologin.asp

4 Major Unexpected/unplanned loss of life, or permanent impairment of quality of life on a single scale

Result in loss of >5% of research revenue Result in serious adverse publicity for the School and CSU and significant

loss of reputation Required retraction of published article/s Lead to serious legal action against researchers and CSU Result in research progressing without ethics committee approval

(researchers lose protection of institution and insurers) 5 Severe Unexpected/unplanned loss of life, or permanent impairment of quality of life

on a multiple scale Screening program terminated Result in serious adverse publicity for the School and CSU and significant

loss of reputation Result in a parliamentary enquiry and loss of government confidence

The overall level of risk was determined by combining the consequence and likelihood ratings

Consequence

Likelihood 1Insignificant

2Minor

3Moderate

4Major

5Severe

A Almost certain

L M H E E

B Likely L M H E EC Possible L L M H ED Unlikely L L M H HE Rare L L L M H

(Adapted from AS/NZS 4360:2004, Risk Management. Under the CSU risk management approach the colour of the risk grade will be contingent on likelihood, consequence and risk grade calibrations that are agreed with the activity sponsors.)

Key:

L = low risk managed by routine procedures. No major concern M = Moderate specified responsibilities of Coordinator Dr H. JelinekH = High risk attention/monitoring by Coordinator Dr H. JelinekE = Extreme risk immediate action required


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Table 1 Risk assessment and risk management plan. Likely circumstances Assessment of risk Major consequences if risk not managed Risk management strategies

Likelihood Consequence Risk001/06 Fraud in collection of data Identified risks: Researcher responsible for interviewing patient invents data rather than following protocol Researcher alters data to make the results more likely to fit his/her preconceived idea of what results should show

Where researcher: collects data without close supervision have not been appropriately trained and

briefed operate without their data being checked operate without proper supervision

Occasionally Study data may be worthless resulting in

unreportable and unpublishable results Published article may require retraction Screening may need to be repeated at

considerable cost and effort Ethics committee needs to be notified

Develop a strong culture emphasising care and accuracy in data collection

The Coordinator to ensure all researchers are adequately trained in research methods/ethics.

Research protocols are required to have adequate quality control procedures which are likely to detect falsified data. The Coordinator to ensure that quality control measures are reviewed.

All new researchers will be adequately briefed on the need for accuracy in data collection.

Standard operating procedures in place for most key data collection procedures, including quality control procedures

002/06Serious errors in analysis of data Identified risks: Serious error made in the analysis of a data set leading to the need to retract a published article or correct a report. Researcher may fraudulently alter results to fit preconceived hypothesis or to increase the likelihood of publication of the results. Colleagues involved in current and previous research could have their reputations tarnished.

Serious errors are more likely if data analysis is undertaken by inexperienced & unsupervised persons.

Inappropriate application of computer data analysis by inexperienced people

Occasionally through inexperience or inadequate supervision

Study data may be worthless resulting in unreportable and unpublishable results

Published article may require retraction

Ensure that all key research data is analysed by two independent persons, with a statistician involved

All PhD students should have key results checked by a statistician

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003/06 Loss of data due to inadequate back-up proceduresIdentified risks: A systematic process with frequent inspection is required for updating and regular backing up of previous copies of the database.Database kept in a secure location.

When databases are established and maintained by researchers without the close support of an experienced programmer or database manager.

When databases are constantly being updated, especially if more than one person is involved in data entry or if different people are involved in data entry and data editing.

At the data checking/editing stage it may be easy to lose track of which is the most current version of the database.

A substantial risk of data loss due to theft, malicious destruction or fire may occur if all copies of a database are kept in the one location or on the same computer

Almost certain, unless specific precautions are taken

Irretrievable loss of essential data Expenditure of considerable expense

and time in reconstructing the database

Other funding implications (eg. cost of repeating research)

Develop detailed standard operating procedures relating to data management

Provide training in data management procedures via short course and/or postgraduate programs

Coordinator to review data management procedures Daily back up of data files

provision of training in data management procedures via short course and postgraduate programs

review of data management procedures as an essential component of reviews conducted by the research auditor

004/06 Serious breach of protocol or ethics committee requirementsAll research involving humans must be endorsed by Charles Sturt University’s human ethics committee. The committee requires all study participants to be provided with an approved information sheet and to sign an informed consent sheet that indicates their readiness to participate in the project. These forms must be readily available for auditing purposes and should a participant claim that they had not been adequately informed of the risks and benefits of participation. Serious adverse events affecting any study participant, and considered reasonably likely to have resulted from study participation, must be notified urgently to the human ethics committee.

Where the Coordinator becomes too busy to provide adequate supervision of the research programs.

Lack of knowledge of the ethics committee’s role in the regulation and monitoring of the research program.

Likely Research may not take place without

ethics committee approval. Adverse events affecting a participant

could lead to serious adverse publicity.

Insist on adequate training of researchers Coordinator to monitor compliance with ALL human ethics

committee requirements


005/06Serious breach of confidentiality The human ethics committee approves the collection of personal health-related data for research purposes only if they are assured that the data will be maintained under strict conditions that protect the confidentiality of the participants.

Privacy requirements to be observed by researchers have become more explicit with the adoption of new legislation that must be observed by all those involved in the collection of personal data. Breaches of these requirements may result in criminal penalties.

Components of the procedures required for privacy protection include: restriction of access to personal data to a small number of individuals with a need for access training of researchers at all levels in the issues related to data confidentiality provision of secure storage of confidential data which includes restricted access to areas where such data is stored, separation of identifying data from the other data elements, secure password access to data in

computers and development of a specific protocol for destruction of identifying data when no further need exists to retain this information. requirement for all staff involved in data collection or processing to sign a confidentiality declaration at yearly intervals

where there has been little attempt to create a culture of confidentiality and reinforce it.

where new researchers who have not been adequately educated about the rationale for confidential data handling are given responsibilities in this area.

where a research staff member handles data from an individual known to the researcher and is tempted to mention this outside the university

Likely Could result in serious

adverse publicity May lead to legal action

from participants whose privacy has been breached

Require all researchers to sign an annual confidentiality agreement Coordinator to emphasise privacy requirements to researchers Coordinator to create a culture of confidentiality

006/06Failure to identify and follow up an abnormal test resultsIdentified risk: Many research studies involve the measurement of physiological variables (eg blood pressure). When large numbers of individuals are tested, there is a strong possibility of finding abnormalities of clinical significance that may not be known to the individual or his/her medical practitioner. In some instances, recognition of the abnormality may allow effective treatment to be introduced.

The primary risk setting is where screening tests are being done on large numbers of individuals either as part of eligibility screening for a research study or as part of an epidemiological study

Failure to include efficient procedures to pass on important clinical information may mean that a potentially curable illness is not detected

May lead to significant legal action for negligence

All studies involving physiological measurement or laboratory testing must include specific procedures to review all abnormal results.

These procedures must be documented in the protocol and procedure manual and adherence monitored by the Coordinator.

007/06Provision of appropriate insurance cover for CSU students undertaking course related work experience with CSU


008/06Failure to monitor participants effectively or oversee emergency procedures leading to serious injury or death of a participant Identified risk: Some clinical research projects, particularly those conducted on patients with conditions such as hypertension or cardiovascular disease, may require special attention to monitoring and the availability of emergency care. The risk of medical complications resulting from screening tests may be sufficiently high as to mandate the availability of urgent medical assessment and/or emergency care. If such emergency care was not immediately available and, as a result, a study participant died or developed serious complications, serious repercussions would follow for both the investigator and the institution.

The risk is greater when studies are supervised by inexperienced staff and when senior clinical investigators are unavailable or not able to be contacted.

occasionallyMay lead to: death or serious injury to a

participant serious legal action

against researchers serious adverse publicity

Ensure that detailed standard operating procedures are developed Adherence to standard operating procedures to be reviewed by Coordinator

009/06Blood Pressure Recording using a Digital Blood Pressure MonitorIdentified risks: Over-inflation of the cuff may cause minor discomfort

When inappropriately sized cuff is used Slight bruising may occur All persons performing blood pressure measurements will be appropriately trained and the training recorded.

010/06Electrocardiogram (ECG)Identified risks: There are no known risks associated with an ECG, however, participants may have a sensitivity to the electrode adhesive or alcohol skin preparation swab.

Participants will be asked if they have any skin sensitivities All persons performing ECGs will be appropriately trained and the training

recorded.011/06VenipunctureIdentified risks: Patient experiencing nausea, light-headedness, dizziness, fainting. Needle stick injury. If the participant is nervous or the room is

warm If venipuncturist is inexperienced or not

taking due care

Faint - Stick -

Participant may injure themselves while fainting if not supported

Needle stick injury to either participant or venipuncturist

Maintain room at a comfortable temperature Have the participant lying down while taking the blood Inform the participant of the possibility of discomfort. Ask them if they have

previously fainted. Have available the following first aid measures:

- first aid kit- first aid officer- emergency phone numbers near the most accessible phone

All persons performing venipuncture will be appropriately trained and the training and competency recorded.

012/06Finger prickIdentified risks: nil


Standard Operating Procedures (SOP)


30

Venipuncture Technique Using the Multisample Vacutainer System

SOP No:....................................Version: 1.0..................................Date: 3 April 2006

Dept/Div/School: School of Community Health

Supervisor/Manager: Cherryl Kolbe

Other Contacts: Bev deJong

RISKS/HAZARDS: Venipuncture is a procedure where there is this potential for direct contact between the skin (usually finger or thumb) of the blood collector and a sharp surgical instrument such as a needle.

It is essential that realistic assessments are made of the likelihood and severity of any injuries arising from venipuncture. Both physical and psychological risks must be assessed.

a) Ethical issues Subjects should not feel they have been abused as a result of

venipuncture. This could include excessive pain or discomfort and embarrassment or humiliation.

b) Physical Risks Patient experiencing nausea, light-headedness, dizziness,

fainting Needle stick injury

PROTECTIVE & EMERGENCY EQUIPMENT

Disposable gloves Gown & protective eyewear if appropriate There must be a First Aid / CPR trained person available in case of an

emergency. Emergency procedures must be in place – refer to Physiology

Laboratory “Guidelines for Medical Emergencies”

CONTROL MEASURES Inform the patient of the possibility of discomfort or embarrassment. Have the patient lying down with the head slightly raised on a pillow. Have available the following first aid measures:

first aid kit first aid officer emergency phone numbers near the most accessible phone

Only suitably qualified and experienced staff may perform venipuncture

Those performing venipuncture must comply with the following Physiology Laboratory Guidelines:

Venipuncture Medical Emergencies Infection Control


STANDARD OPERATINGPROCEDURE

31

EQUIPMENT................... Clinically clean table outside laboratory area Tourniquet Appropriate vacutainer tubes (per person), labelled.

2 x 7ml EDTA tubes (purple top) 1 x 10ml tube with 100L preservative heparin 1 x 7ml plain tube (orange top)

5ml plain tubes for Hcy (one per person) 21g multiple sample needle or 21g winged infusion device Plastic sleeve to hold specimen tubes Isopropyl alcohol (70%) swabs Cotton wool balls Adhesive plaster or bandaids Disposable gloves Laboratory coat Sharps container Eye protection if deemed necessary by risk assessment

JOB STEPS Ensure all equipment is within easy reach and accessible. Select tube or tubes appropriate for samples desired. (see note at

end). Label the tubes. Tubes that contain additives should be gently tapped to dislodge any

additive, which may be trapped around the stopper. Open needle package, but do not remove needle shield. Thread

needle onto holder. Select site for venipuncture. Put on the disposable gloves Apply tourniquet. Prepare venipuncture site with an appropriate

antiseptic. (isopropyl alcohol swab) DO NOT PALPATATE VENIPUNCTURE SITE AFTER CLEANSING. Place patient's arm in a downward position. Remove needle shield. Insert the needle into the vein ensuring the bevel of the needle is

uppermost.

Push tube onto holder, puncturing the diaphragm of the stopper.

If no blood flows into tube or ceases to flow before an adequate sample is collected, the following steps are suggested to complete satisfactory collection:

Change the position of the needle. Move it forward (it may not be in the lumen)


32

or move it backward (it may have penetrated too far)

Adjust the angle (the bevel may be against the vein wall)

When first tube is full and blood flow ceases, remove it from the holder.

While each successive tube is filling, invert the previous tube containing additives 8-10 times. DO NOT SHAKE. Vigorous mixing can cause haemolysis.

Release the tourniquet after inserting the last tube. When the last tube has been removed (gold to tube), gently cover the needle tip with a cotton wool ball and remove the needle from the vein. Ask the patient to apply pressure to the puncture site until bleeding stops.

After the venipuncture, dispose of the holder and the needle into an approved sharps container.

Transfer the contents of the gold top vacutainer tube to the tube containing the preservative free heparin and invert gently to mix.

Check the patient’s arm and cover the site with a bandaid. Do not allow the patient to leave until the bleeding has stopped.

If breakage of a tube containing a collected sample should occur, avoid all contact with the exposed skin and follow proper procedures for the clean up and disposal of infectious waste.

WHEN YOU FINISH Discard gloves and wash hands.


33

Sample tubes for collection

Tube Test Volume of whole blood Requirement Storage

EDTA Homocysteine 8ml Plasma -800C

EDTA MetHb, viscosity 8ml Whole blood Room temp

Preservative free Heparin

GSH, MDA4ml

RBC hemolysate -40CD-dimer, cholesterol profile Plasma -200C

2 x 7ml EDTA tubes (purple top)

1 x 7ml plain tube (orange top)

1 x 10ml tube with 100L preservative free heparin

Collect the two EDTA tubes first and the plain tube last. As soon as the plain tube is collected transfer the blood to the tube containing the preservative free heparin. Invert well to mix. Place this tube and a 7ml EDTA tube in a rack and keep on ice until collected by biochemist.

Centrifuge one 7ml EDTA tube. Collect plasma, label and store at -800C.


34

Blood Collection by Finger Prick

SOP No: ...........................….Version: ………1.0……………..Date: March 2001

Laboratory Manager: Cherryl Kolbe Ext. 16995

Other Contacts: Bev deJong Technical Officer Ext. 16995

HAZARDS: Lancet stick

PROTECTIVE EQUIPMENT &

Disposable gloves Face mask and/or protective eye if required

EMERGENCY First aid kit availableEQUIPMENT

BEFORE YOU START Wash hands in warm soapy water Rinse well and dry completely

NEVER.........................

JOB STEPS If using an alcohol wipe, let the finger dry completely before testing

Warming fingers can increase blood flow Prepare the lancet device according to the manufacturers

instructions Put on disposable gloves Prick the finger to obtain the blood sample Cover the wound with a cotton ball held in place by the patient Dispose of the lancet in an approved sharps container Remove the cotton ball and apply a spot band

WHEN YOU FINISH Remove gloves Wash hands in warm soapy water Rinse well and dry completely


Standard Operating Procedure (SOP)

35

Manual Blood Pressure Measurement

SOP No: ...........................….Version: ………1.0……………..Date: May 2006



HAZARDS: Over-inflation of the cuff may cause minor discomfort


nil


BEFORE YOU START Wash hands in warm soapy water Rinse well and dry completely Have the participant assume a relaxed supine position for 5

minutes prior to taking a resting BP measurement. The arm should be at the level of the heart with the palm up for Brachial measurement , legs should be in a near horizontal position knees slightly flexed for Ankle measurement

Observe and question participant for contraindications for taking BP (i.e. lymphedema) and signs and symptoms of BP alterations: high (headache, flushing of face, nosebleed, fatigue in older adults) and low BP (dizziness; mental confusion; restlessness; pale, dusky or cyanotic skin; cool, mottled skin over extremities)

NEVER.........................

JOB STEPS Explain the procedure to the participant Select appropriately sized cuff Expose the extremity fully by removing any constrictive

clothing Palpate the brachial artery (arm) or posterior tibial (leg) Position the cuff 2.5cm above the site of pulsation Apply the cuff above the artery by centring the arrows

marked on cuff over the artery Wrap the fully deflated cuff evenly and snugly around the

extremity If the participant’s baseline BP is unknown, estimate the

systolic pressure by palpating the artery distal to the cuff with the fingertips of one hand while inflating the cuff rapidly to a pressure 20mmHg above the point at which pulse disappears. Slowly deflate the cuff and note the point when the pulse reappears. Deflate cuff fully and wait 30 sec.

Place the stethoscope earpieces in ears and ensure S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete doc(190706).doc


36

sounds are clear. Place the bell or diaphragm chest-piece of the stethoscope over the artery without touching any clothing.

Close the valve and rapidly inflate to 20mmHg above the systolic pressure

Slowly release pressure bulb valve and note the point when the first clear sound is heard.

Continue to deflate the cuff, noting the point at which the sound disappears

Release the remaining air quickly

WHEN YOU FINISH Record your results

Wash hands


37

Ankle Brachial Index (ABI)

SOP No: ...........................….Version: ………1.0……………..Date: June 2006



HAZARDS: Stepping down from plinthnil


nil


BEFORE YOU START Wash hands in warm soapy waterRinse well and dry completely

NEVER.........................

JOB STEPS Doppler

Technique

Automated digital Blood Pressure

Measure highest systolic reading in both arms Record first Dopplerdoppler sound as cuff is deflated Record at the radial pulse

Measure systolic readings in both legs Cuff applied to calf Record first Dopplerdoppler sound as cuff is deflated Use Dopplerdoppler ultrasound device Record dorsalis pedis pressure Record posterior tibial pressure Use highest ankle pressure (DP or PT) for each leg when calculating ABI.

Apply digital cuff of correct size and record brachial BP for each arm

Apply cuff to ankle (leg slightly flexed at knee) ensuring that the cuff lies firmly and flat against the skin, ensure tubing is not bent and that the arrow is aligned with the posterior tibial artery. Record BP for each leg



38

A cushion may be used to support the lower leg

WHEN YOU FINISH Calculations Ratio of each ankle to brachial systolic blood

pressure Divide each ankle systolic pressure by

corresponding systolic brachial pressure Interpretation Ankle-Brachial ratio >0.95: Normal Ankle-Brachial ratio <0.95: Peripheral Vascular Disease Ankle-Brachial ratio <0.6: Intermittent Claudication Ankle-Brachial ratio <0.5: Multi-level disease Ankle-Brachial ratio <0.26: Resting ischemic pain Ankle-Brachial ratio <0.2: Gangrenous extremity False Negative Test: Diabetes Mellitus Vessels in diabetics are poorly compressible Results in falsely elevated ankle pressure

For elevated ankle SBP indicating calcification use the ruler adjustment and measure again.Management Segmental Arterial Pressure indicated for ratio < 0.9 Consider angiography or Magnetic resonance angiography


39

http://www.fpnotebook.com/SUR31.htm

http://www.fpnotebook.com/END11.htm



Body Mass Index (BMI)




A measure of body weight relative to height. BMI can be used to determine if people are at a healthy weight, overweight, or obese.HAZARDS: nil


nil



NEVER.........................

JOB STEPS Greet the participant & explain what you are going to do Ask the participant to remove their shoes and any heavy items

from their pockets Record weight in kg using bathroom scales Record height in meters using the stature meter Record waist circumference in cms - do not approach the

participant from the front

WHEN YOU FINISH Calculate Body Mass Index (BMI) as follows:

Weight (kg) _________

Height2 (m)



40

Use of Tiptherm ™

SOP No: ...........................….Version: ……………………..Date: 28 June 2006…………..

Laboratory Manager: C. Kolbe Ext. 16995

Other Contacts: B. de Jong Technical Officer 16885

HAZARDS: No known hazards


Nil



NEVER.........................

JOB STEPS

Hold the tip therm device against the skin on each foot in 5

different places

Ask the participant to indicate whether it is hot or cold.

Record the results

WHEN YOU FINISH Wash hands in warm soapy water Rinse well and dry completely



41

Autonomic Nervous System Function Tests (Ewing Battery)




HAZARDS Over-inflation of the cuff may cause minor discomfort



EQUIPMENT NEEDED Use a standard sphygmomanometer and cuff of appropriate size Dynamometer Macintosh computer, electrode leads, etc Disposable mouthpieces balloons

JOB STEPS

1. Blood pressure response to standing

2. Blood pressure response to sustained handgrip

Have the participant lying down Position the cuff and measure the blood pressure (BP) Ask the participant to stand up Measure at 1 minute post standing Measure again at 3 minutes post standing

Explain the dynamometer and determine maximum hand grip of the dominant arm

Position the cuff on the opposite arm Measure BP at rest Ask the participant to squeeze the dynamometer (30% maximum

voluntary contraction) Record time and BP at 1 minute intervals up to 5 minutes

Note: If the participant cannot hold for the full 5 minutes allow them to release their grip and record tis on the sheet.

Measure of response: This is the difference between the diastolic BP before starting and diastolic BP just before release of hand grip.



42

3. Heart rate deep breathing

4. Heart rate response to standing up

5. Heart rate response to lying

6. Valsalva manoeuvre

Attach electrode leads as per 3 lead ECG SOP Allow the participant to rest quietly for 3 minutes Recorded the heart rate (HR) for 5 min while patient is breathing

quietly After a further 2 minute interval the heart rate is recorded for a

further 1 minute interval of deep breathing at 6 breaths per minute (5 sec inspiration and 5 second expiration).

Note: All participants are to have a practice session before recording commences. The maximum and minium heart rate for each breathing cycle is measured and the mean of three successive breathing cycles is taken to give the maximum-minimum heart rate. Measure heart rate as standing from lying position. Take 30:15

interval.

Measure heart rate as lying from standing position. Take 30:15 interval.

Attach Pulse oximeter and check O2 saturation # If O2 saturation < 95% and/or patient has a CVD or respiratory condition advise clinical supervisor before continuing with this test.

Participant sits quietly and then blows into the disposable mouthpiece at 40mmHg for 15sec.

Rest 30 sec and then repeat 4 times

Note: Heart rate increases normally followed by rebound bradycardia after release. The ratio of the longest RR interval shortly after the manoeuvre to the shortest RR interval during the manoeuvre is measured. The Valsalva ratio is the mean of three successive manoeuvres.

WHEN YOU FINISH Remove the leads from the participant


43

3-lead Electrocardiogram (ECG)

SOP No: .........................................….Version: ………1.0……………..Date: May 2006



HAZARDS: There are no known risks associated with an ECG.


nil


BEFORE YOU START

Wash hands in warm soapy water Rinse well and dry completely Welcome the participant and introduce the staff/student members present



44

JOB STEPS

Software Setup

Electrode Attachment

Recording the ECG

First SegmentStanding to Lying

1. Turn on the Macintosh computer2. Double click on the desktop icon ‘Diabetes 3 lead ECG’ to open Chart V3.63. Click on Setup > Channel Settings4. Reduce the number of channels to 15. Click on Bioamp and enter the following settings

Range 1MVNotch ONHigh Pass 0.3 HzLow Pass 50 Hz

6. Click on OK7. Click on OK to close the channel settings window

1. Ask the participant if they have any allergies to bandaids or alcohol wipes.2. To ensure a stable artefact free ECG the skin should be properly prepared. Remove any

hair at the electrode site and clean the area with an alcohol wipe. Allow to dry.3. Attach the electrode leads to the disposable electrodes prior to placement on the

participant.4. The ECG leads should be positioned as shown in the following diagram. Peel the

electrodes off the card and attach to the participant.(R) clavicle neg electrode(L) hip pos electrode(R) hip ground

5. Make stress loops with the leads and attach firmly to the skin with micropore tape. You will be shown how to do this.

1. Ask the participant to stand relaxed in front of the bed with their arms to the side and explain to them the series of recordings and what they are expected to do. ie. Remain still and quiet.

2. Click on start and ensure the trace is free of noise. It is essential to have a noise-free recording – if there is noise in the recording check the electrode attachments. This is usually the reason.

3. When satisfied with the trace click on Stop.

1. Click on File > New > Don’t Save. This will open a new recording.2. Click on Start3. Record for 30 secs & then insert a marker by double clicking on Stop (this also restarts

the timer)4. Ask the participant to lie down and continue the recording for another 30 secs.5. Click on Stop.6. Click on File > Save As > and then enter the file name: SL_code name_date eg

SL_KOLC220253_300506

7. Select windows data file which adds the code adicht 8. Click on Save


45

Second SegmentLying

Third SegmentLying to Standing

1. Click on File > New 2. Click on Start3. Record for 20 mins. Don’t forget to set your timer.4. Click on Stop > File > Save As and then enter the file name: 20min_code name_date

eg

20min_KOLC220253_300506

5. Select windows data file which adds the code adicht 6. Click on Save

1. Click on File > New2. Click on Start3. Record for 30 secs, then insert a marker as before4. Ask the participant to stand (ensure they aren’t light headed on standing)5. Continue the recording for another 30 secs6. Click on Stop.7. Click on File > Save As > and then enter the file name: LS_code name_date eg

LS_KOLC220253_300506

8. Select windows data file which adds the code adicht 9. Click on Save10. Click on File > New11. Now you are ready for the next participant12. Remove the electrode leads and disposable electrodes from the participant and check

that all the adhesive is removed

WHEN YOU FINISH

Wash hands

Now you are ready for the next participant


46

12-lead Electrocardiogram (ECG)

SOP No: .........................................….Version: ………1.0……………..Date: May 2006



HAZARDS: nil


nil


BEFORE YOU START

Wash hands in warm soapy water Rinse well and dry completely Welcome the participant and introduce the staff/student members present

JOB STEPS Give the participant a brief outline of the procedure 12 lead ECG to test the heart describing the electrode placement to them Explain that ECG measures “the electrical wiring” (most people will relate to

pacemaker) of the heart, emphasise that the process does not apply any electrical stimulation.

Enquire if the participant has previously undergone a 12 lead ECG recording Ask the participant if they have a sensitivity to bandaids or adhesive plaster – record on

sheet Ask the participant to remove their undergarments and replace their outer shirt leaving it

untucked and unbuttoned at the front. They may then lie down. Ensure that the area is enclosed for privacy

Note: Students should leave the room while the participant is undressing.

To ensure a stable artefact free ECG the skin should be properly prepared. Using a disposable razor remove any hair at the electrode site and clean the area with an alcohol wipe. Allow to dry.

Ask permission to feel along the ribs prior to electrode placement

Electrode Placement: Apply the precordial electrodes as outlined below:

V1: In the fourth intercostal space at the right sternal border. V2: in the fourth intercostal space at the left sternal border. V3: mid-way between V2 and V4. V4: in the fifth Intercostal space in the mid-clavicular line. V5: in the left anterior axillary line at the level of V4. V6: In the left mid-axillary line at the level of V4.(Directly under the midpoint of the armpit)



47

Note: It is essential to be discrete whilst placing precordial electrodes on women. If practical, leave the breasts covered. Attach the limb leads appropriately to the ankles and wrists. Ask the participant if they are in a comfortable position and require a blanket or a pillow

under their knees if they experience back pain.

Recording ECG

Double click on the CardioPerfect desktop icon to open the program

Enter the word ”admin” as the password and click on

10 Second Recording Click on File > New> Patient The PatientCard window will appear Enter information as shown in the figure below (eg patient code_length of

recording_date) Click OK

Click on > ECG

The New ECG window should appear


48

Click OK The recording window will appear

When the trace has stabilised, click on Turn off the recording device when prompted The recording will automatically be saved

5 Minute Recording Click on File > New> Patient The PatientCard window will appear Enter information as shown in the figure below (eg patient code_length of

recording_date) Click OK


49

Click on > ECG

The New ECG window should appear

Click OK The recording window will appear


50

When the trace has stabilised, click on Turn off the recording device when prompted The recording will automatically be saved

Remove the electrode leads and disposable electrodes from the participant and check that all the adhesive is removed

WHEN YOU FINISH

Wash hands

Now you are ready for the next participant


51

Risk Assessments


52

Venipuncture

Name and status of Assessor: C. KolbeSenior Technical Officer

Date: 2.4.01

1. IntroductionAn “Exposure prone procedure” (EPP) is a term usually characterised by any situation where there is a

potentially high risk of transmission of a blood borne disease from a worker to a patient (or vice versa) during a medical procedure. Venipuncture is a procedure where there is this potential for direct contact between the skin (usually finger or thumb) of the blood collector and a sharp surgical instrument such as a needle.

It is essential that realistic assessments are made of the likelihood and severity of any injuries arising from venipuncture. Both physical and psychological risks must be assessed.

2. Risksc) Ethical issues

Subjects should not feel they have been abused as a result of venipuncture. This could include excessive pain or discomfort and embarrassment or humiliation.

d) Physical Risks Patient experiencing nausea, light-headedness, dizziness, fainting Needlestick injury

3. Control Measures a) Inform the patient of the possibility of discomfort or embarrassment. b) Have available the following first aid measures:

- first aid kit- first aid officer- emergency phone numbers near the most accessible phone

c) Only suitably qualified and experienced staff may perform venipunctured) Those performing venipuncture must comply with the following Physiology Laboratory Guidelines:

- Venipuncture- Medical Emergencies- Infection Control

4. Emergency Procedures a) There must be a First Aid / CPR trained person available in case of an emergency.b) Emergency procedures must be in place – refer to Charles Sturt University Physiology Laboratory “Guidelines

for Medical Emergencies”

5. Remaining Risk If the control measures outlined above are maintained, the risks will be reduced considerably.


RISK ASSESSMENT

53

Electrocardiogram (ECG)

Prepared by: C. KolbeSenior Technical Officer

Adoption Date: 7 March 2001

An electrocardiogram, or ECG, records the rhythm and electrical activity of your heart.

Several small electrodes are attached to the arms, legs or chest and connected to an ECG recording device. The electrodes are connected to electrode leads which are connected to the ECG recorder. This recorder picks up the electrical signals produced by each heartbeat and prints out the recording onto paper. The ECG device only records signals from the body. It does not give electric shocks and does not affect the heart in any way. The entire test takes several minutes and there is no discomfort.

1. Hazards An ECG is a safe, painless test that provides no discomfort to the patient. There are no known risks

associated with an ECG.

2. Precautions Hair may sometimes need removal to allow for correct attachment of the electrodes. This will only

be performed with a single use razor. Electrodes must be firmly attached to the chest to permit accurate recording of the heart's activity.

3. Training Requirement All persons performing an ECG will be appropriately trained and their training recorded.

4. Level of Risk Remaining There are no known risks associated with performing an ECG.


RISK ASSESSMENT

54

Blood Pressure Recording using a Sphygmomanometer and Stethoscope



The usual method of measurement of blood pressure is a non invasive means that uses a sphygmomanometer, which includes either a column of mercury or pressure-registering gauge. With this technique, the flow of blood is temporarily stopped by an inflated cuff that is wrapped around the upper arm and that puts pressure on the main artery in the arm. Blood flow is then gradually restarted as the user slowly deflates the cuff.

1. Hazards Exposure to mercury from a broken sphygmomanometer. Over-inflation of the cuff

2. Precautions

Precautions must be taken to limit the inhalation, ingestion or absorption of mercury in case of a spill or breakage. Mercury is a silver-coloured metallic element that is liquid at room temperature and tends to break into tiny, highly mobile droplets when spilled. These droplets vaporize and can contaminate the atmosphere. Exposure to mercury from sphygmomanometers used in health-care settings is extremely rare.

Selecting appropriately sized cuffs is critical. The appropriate cuff width is based on the diameter of the upper arm. Taking blood pressure measurement with a cuff that is too narrow could overestimate blood pressure, while too wide a cuff can underestimate the pressure.

3. Training Requirement All persons performing blood pressure measurements will be appropriately trained and the training

recorded.

4. Level of Risk Remaining If due care is taken the level of risk remaining is low.


RISK ASSESSMENT

55

Blood Pressure Recording using a Digital Blood Pressure Monitor



Use of the digital blood pressure monitor is safe and non invasive. With this technique a cuff is wrapped around the upper left arm and a rubber bulb is squeezed rapidly to inflate the cuff. The cuff pressure then slowly decreases until the systolic and diastolic pressure readings are displayed. The auto inflation bulb is then released to expel all the air from the cuff.

1. Hazards Over-inflation of the cuff may cause minor discomfort

2. Precautions

Selecting appropriately sized cuffs is critical. The appropriate cuff width is based on the diameter of the upper arm. Taking blood pressure measurement with a cuff that is too narrow could overestimate blood pressure, while too wide a cuff can underestimate the pressure.

3. Training Requirement All persons performing blood pressure measurements will be appropriately trained and the training

recorded.

4. Level of Risk Remaining If due care is taken the level of risk remaining is low.


RISK ASSESSMENT

56

Emergency Procedures


57

Cedar Floor Plan


58

Diabetes Complications Screening Emergency Response

SOP No: ...................................….Version: ………1.0……………..Date: May 2006



Rationale: Given the number of participants enrolled in the screening program and their co-morbidities including diabetes, cardiovascular disease including hypertension and diseases associated with aging the emergency response below has been developed in the event of a medical emergency.

EMERGENCY EQUIPMENT

Telephone First aid kit Resuscitation Equipment List of First Aid Officerso Bev De Jong Physiology Lab (Back Wilcara) 16858o Tim Rowston Photography 16914o Karen Scheetz Library 16877o Steve Knox Services Officer (Secutity) 16888o Corey Fisher Services Officer (Security) 16888

These staff all have current Intermediate First Aid and Cardio-Pulmonary Resuscitation certificates.

JOB STEPS Conscious patient with chest pain and or difficulty of breathing

Unconscious Patient Breathing

Unconscious not breathing

Put patient on a bed or chair, whichever is closer, should not be walked, wheel chair needed.

Call for Help Apply Oxygen at 6L via a Hudson mask Call RN or First Aid Officer (Bev deJong) to assess the patient Phone ambulance 000 as appropriate

Turn patient on the left lateral side Call for help Maintain airway and apply Oxygen 8L Hudson to assess the patient Call ambulance DRABC (Check for Danger, Response, Airways, Breathing and

Circulation) Call ambulance 000 Call RN or First Aid Officer (Bev deJong) Perform CPR as appropriate

Note: In service will be provided by Paul Warner to communicate this procedure to staff and students involved in the Diabetes Complications Screening program.

WHEN YOU FINISH Make sure an accident/Incident report is completed



59

Hypoglycaemia Emergency Response

SOP No: ...........................….Version: ………1.0……………..Date: 2004



SIGNS & SYMPTOMS: Excessive sweating Shanking and/or trembling Feeling faint Headache Blurred vision Irritability Extreme hunger Racing / pounding heart Personality change eg aggression Lethargy and/or drowsiness Coma / fitting

EMERGENCY EQUIPMENT

First aid kit available Resuscitation equipment

JOB STEPS for theCONSCIOUS PATIENT

Perform a blood glucose test If < 5mmol/L administer quick acting sugar in the form of:

o 5-7 jelly beanso warm sugary drink (eg tea or coffee)o ½ can of regular soft drinko fruit juice

After several minutes redo the blood glucose and administer long acting carbohydrate in the form of:

o 2 sweet biscuitso breado fruit

After 30 minutes redo the blood glucose which should be > 5mmol/L

JOB STEPS for theUNCONSCIOUS PATIENT

Call 000 and remain with the patient Do not administer anything by mouth Position patient on the side Clear the airway Tilt the head slightly and support the jaw Check vital signs



60

Fainting Emergency Response

SOP No: ...........................….Version: ………1.0……………..Date: 2004



Fainting may be caused by nervous excitement (venipuncture). The victim looks shocked, feels faint and giddy and may collapse.

EMERGENCY EQUIPMENT

First aid kit available Resuscitation equipment

JOB STEPS Lay the patient down if not already on the floor Raise both legs Loosen any tight clothing at the neck and waist Apply a cool towel to the head Apply Oxygen if available – Hudson mask @ 6-8L/min Check for pupillary response Ventilate room Reassure the patient if awake Do not give food or drink until the patient has recovered fully Assist the patient to a seated position when they feel ready Assist the patient to a standing position when they feel ready



61

Student Screening Documents


62

Student Acknowledgement Statement

I have read and understand the emergency guidelines for the Diabetes Complications Screening and Research.

I understand the information and data collected during the Diabetes Complications Screening and Research at Charles Sturt University is strictly confidential.

I will, under no circumstances, discuss any of the information I may come in contact with while participating in the Diabetes Complications Screening and Research.

I understand that I can elect not to participate or allow my results to be used in the Diabetes Complications Screening and Research.

I understand that my participation as part of my course work requirement is acknowledged.

Name:

Signature:

Date:


63

Student feedback for diabetes complications screening

Course enrolled in: Year of course Have you had any professional health care experience before starting your university course?

If yes above, what did you do?

Describe the most interesting/relevant experience you gained during your placement with the diabetes complications screening.

Has your participation in the diabetes complications clinic helped you clarify your understanding of the role of your profession within diabetes health care?

If yes above, elaborate please.

What do you understand research to involve?

Are you interested in research?

What do you understand research to imply within your profession?

Has your participation in research helped you clarify your understanding of the role of research in the nursing profession? Describe the most interesting/relevant experience you gained during your research project.

Describe the most irrelevant experience you gained during your research project

Can you see any relevance of the research project you participated in to everyday health care in your profession? If so, explain. If not, explain.


64

Diabetes Complications Screening Forms


65

Charles Sturt UniversitySchool of Community Health

PO Box 789Albury NSW 2640

Tel (02) 6051 6000

Information Sheet

Diabetes Complications Screening Project

You are invited to participate in a student education / research project of complications associated with diabetes such as heart disease, eye and foot disease. This study is being conducted by Dr Herbert Jelinek and includes several clinicians and scientists associated with Charles Sturt University as well as other local physicians, national and international research institutions. Podiatry students will be on placement and nursing students will be attending as part of their course work requirements. In addition postgraduate students may be in attendance.

The main purpose of the study is to determine whether regular screening is of benefit to the rural community and contribute research output including automated procedures for detection of changes in the eye and heart associated with diabetes as well as identifying early changes in blood constituents that allows risk assessment for diabetes and cardiovascular disease. We invite you to continue to participate annually to assess your heart, eye and foot health as well as blood pressure and other health indicators.

If you decide to participate in this research you will be asked to complete a questionnaire about your general medical history and medications. You may also be invited to participate in a related study investigating your use and attitudes towards complementary medicines. You will have a series of clinical tests for the following diabetes complications.

Please note that the screening will provide feedback of most results to you. However the results can not be seen as a clinical diagnosis and should be confirmed by your general practitioner.Blood: 20 ml will be collected via venipuncture for biochemical tests including markers of oxidative stress and glucose.

Heart: Blood pressure will be recorded whilst lying and standing. A 12-lead ECG recording lasting for 5 minutes. A 3-lead 20 minute recording – this will commence whilst standing followed by 20 minutes of lying down and a final small recording taken immediately upon standing again. The ECG recording involves attaching sensors to your skin. It may be necessary to clean a small area of skin, with an alcohol swab and/or shaving, to ensure the sensors are attached properly. Whilst your ECG is recorded we will also record your oxygen saturation in the blood. The main risk with the ECG recording is temporary dizziness when you move from lying to standing, similar to getting out of bed too quickly. In order to prevent any problems you will be monitored and assisted throughout and following the recording. If any abnormality is detected in your ECG recording you will be informed and we will suggest you contact your GP.

Autonomic Nervous System Function Tests: several tests may be done including blood pressure response to a sustained handgrip (30% maximal), heart rate monitoring whilst deep breathing and performing the Valsalva manoeuvre (breathing out forcefully five times) If you have a known heart or respiratory problem you should not take part in the Valsalva test.Eyes: a photo is taken of the retina of each eye. The flash may momentarily blind you and you may see a blue halo. This disappears within 10 minutes from the photo being taken. The photograph is then assessed by an ophthalmologist at the Albury Eye Clinic and you will be

informed if there is any abnormality detected. There is no recorded risk associated with this procedure however if you have a cataract or other eye disease please inform the technician taking photographs.

Feet: You will be asked to complete a foot health and claudication. Clinical tests are for sensation response of the feet and we will take blood pressures at each ankle for comparison with each arm. This is a common test for peripheral vascular problems in diabetes and is known as the ankle brachial index (ABI). The second test determines your pulse pressure in your ankle and requires a velcro band to be placed around your ankle for five minutes. We do not expect you to have any discomfort with these procedures apart from a short increase in pressure experienced at the arm and leg. A pulse pressure test may also be carried out which involves placement of a small Velcro band around the index finger and big toe whilst we record the changes in blood flow. The band does not exert any pressure on your finger or toe.

Glucose tolerance test: specially selected participants who agree to partake in glucose testing will be asked to drink Glucaid solution (75g glucose in 300ml), finger prick tests for BGL and a urine sample will be collected at half hourly intervals until BGL levels return to normal. Those with diabetes will require clearance from their GP for participation.

Health Care for people with diabetes: There will be a number of medical students from the University of New South Wales Rural Clinical School present that may interview you on your opinion on how well your diabetes is currently managed.

The entire assessment should take approximately 2 1/2 hours. The data collected will be stored on computer before being analysed. Once analysed a portion of the results of the study may form part of research projects undertaken by honours and postgraduate students. Currently Mr Uba Nwose’s Doctor of Philosophy thesis is based on blood constituent information. It is also planned to publish the results in several medical journals. A strip (small section) of an ECG or pulse wave recording may also be published, however any data used will not have any identifying features. The data collected may also be used in future research with other collaborators. In future research the same processes for confidentiality will be adhered to.

Your confidentiality will be maintained at all times, and all data will be depersonalised using a code. Accordingly in any publication, information will be provided in such a way that you cannot be identified. You do not have to participate in this study and can withdraw from the project at any time.

NOTE: The Charles Sturt University’s Human Ethics Committee has approved this project . If you have any complaints or reservations about the ethical conduct of this project, you may contact the Committee through:The Presiding Officer, Charles Sturt University Human Ethics Committee Ph. 02 63384185Any issues you raise will be treated in confidence and investigated fully and you will be informed of the outcome.

Charles Sturt University School of Community HealthPO Box 789Albury NSW 2640

Consent Form

Title of research project Diabetes Complications Screening and ResearchPrincipal investigator Herbert Jelinek

School of Community HeathCSU PO Box 789 Albury6051 6946

1. I, ……………………….……………………consent to my participation in the research project “Diabetes Complications Screening and Research”. 2. I understand that I am free to withdraw my participation in the research at any time3. The purpose of the research has been explained to me and I have read and understood the information sheet.4. I understand that students will be involved in the data collection and consent students to undertake the diverse tests as required and outlined in (5) below.5. I permit the investigator or students to take Blood pressure measurements and a blood sample, Eye photographs, Range of motion measurements, ECG and pulse wave recordings as part of this project. As well as measure blood pressure whilst lying and standing, having a clenched fist and breathing deeply.6. I understand that any information or personal details gathered in the course of this research about me are confidential and that neither my name nor any other identifying information will be used or published without my written permission. 7. I understand that any data gathered in the course of this research may be published and/or used in subsequent research projects.8. I understand that the feedback provided to me consist of data collected as part of the research project and is not a clinical diagnosis. Clinical information regarding the feedback can be provided by my general practitioner9. The Charles Sturt University Human Ethics Committee has approved this study. I understand that if I have any complaints or concerns about the research I can contact: Dr Herbert Jelinek on 60516946.10. I agree that CSU can access my general practitioner / pathology for results relevant to diabetes and cardiovascular disease screening.

GENERAL PRACTITIONER: Name…………………………………….Address…………………………………Phone no………………………………..

……………………………………………… ………………………………………Signature of participant Signature of witness……………………………………………… …………………………………………Name (Please Print) Name (Please Print)……………………………………………… …………………………………………Date Date

Contact Address* ………………………………………….………………………………………….

PHONE NO: ………………………………………….*required to send heart and eye assessment results

Charles Sturt University School of Community HealthPO Box 789Albury NSW 2640


Participants InformationThe following questionnaire is designed to find out some information about your medical history in relation to the study. This information is required so the data can be comprehensively analysed. Your confidentiality will be maintained at all times.

Date ……………….. Male / Female Age …………….years DOB…………………………….

Have you been diagnosed with diabetes?................

Type I [ ] or Type II [ ] Number of years diabetic ………Do you take insulin? ………………..If yes, what type and what dosage?.....................................................................................................

Have you been diagnosed with or are you taking medication for, any of the following? Please tick

Cardiac problems eg Angina [ ], heart failure [ ], atrial fibrillation [ ], heart attacks [ ] Other [ ]

Kidney problems

Reflux Increased sweating

Bladder problems Retinopathy (eyes)

Ulcers on the legs and feet Glaucoma (eyes)

Pain [ ], numbness [ ], tingling [ ] or loss of sensation [ ], cold [ ] or burning [ ] in feet

Stroke

Epilepsy

What are your current prescription medications? (Please include dose)

…………………………………………………………………………………………………….

Have you had any hospitalisations? (If attended clinic previously since last attendance). Provide reason.

…………………………………………………………………………………………………….

Have you had any changes to your medication within the last month prior to this study? Please list.

…………………………………………………………………………………………………….

Have you experienced any dizziness [ ], palpitations [ ] or pain in the chest [ ] or left arm [ ]?

…………………………………………………………………………………………………….Do you have a Department of Veterans Affairs card? Yes No The following measurements are important has they influence heart and blood vessel function

Do you smoke more than 5 cigarettes per day Yes [ ] No [ ] Do you consume more than 2-3 glasses of alcohol per day Yes [ ] No [ ] Have you been told by a health professional (GP, nurse, clinician)

that you have/had High Blood pressure? Yes [ ] No [ ] Are you currently taking medication for High Blood Pressure? Yes [ ] No [ ] Do you have a family history of diabetes Yes [ ] No [ ] Are you currently following a diet? Yes [ ] No [ ]

How much exercise would you participate in, in a typical week? None low moderate high (please circle the correct answer) HRS/WEEK 0 1 2 3 4 5 6 7 8 9 10+

GP PATHOLOGY ENQUIRY:

DATE OF LAST PATHOLOGY TEST (if applicable)………………………

1. When did you last see*: your General Practitioner?………………………….a physician?……………………………….……….an ophthalmologist?.........................…………………a Podiatrist?.....................................…………………a diabetes educator/community health centre………..

* Provide time elapsed since last visit (eg 2 months)

2. If you have diabetes or cardiovascular disease. How often did you see any of the above health professionals within the last year with respect to your diabetes/cardiovascular disease?…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

3. When visiting your GP for a diabetes related consultation, did the GP test for the following diabetes complications?

Eye……………………………… Yes [ ] No [ ]Listen to the heart sounds ...…… Yes [ ] No [ ]Foot………………………………Yes [ ] No [ ]Blood Pressure ………………… Yes [ ] No [ ]

4. Does your GP routinely screen for any of the above regardless of the nature of the visit?Eye……………………………… Yes [ ] No [ ]Listen to the heart sounds ...…… Yes [ ] No [ ]Foot………………………………Yes [ ] No [ ]Blood Pressure ………………… Yes [ ] No [ ]

5. Have you been involved in the screening before? Yes [ ] No [ ]

6. If yes, were you asked to follow up any results with your GP or other health care professional? Yes [ ] No [ ]

How did you follow up?......................................................................................

What was the outcome?…………………………………………………………

If after completing this part of the questionnaire you have any concerns please let the researcher know and you will be provided with options for seeking further information. Thank you

Charles Sturt University School of Community HealthPO Box 789Albury NSW 2640Tel (02) 6051 6000

Participants Assessment Results FeedbackTo: General PractitionerRe: Allied Health Clinic, CSU diabetes screening results

PARTICIPANT’S NAME: PARTICIPANT CODE:

The Diabetes Complications Research Project at Charles Sturt University offers to the public a free screening for complications associated with diabetes as part of an ongoing research study. The test results include finger prick for random blood glucose level, lying to standing blood pressure, Ankle Brachial Index for peripheral vascular disease, sensory testing of the feet for sensory neuropathy, body mass index as an indicator of increased risk of cardiovascular disease and diabetes and a 12 lead ECG 10sec trace. Non-mydriatic colour photographs are also taken of the optic fundus. Tests are carried out by CSU investigators and students. All results are obtained with optimum care, however the results are not intended to take the place of a regular review by your general practitioner

Blood GlucoseBlood glucose was measured.

Blood Glucose Result: Normal values for fasting are levels below 7 mmol/l and for non-fasting (having something to eat within two hours) below 11 mmol/l. A pre-diabetes condition is associated if fasting Blood Glucose levels are greater than 5.5mmol/L but below 7mmol/L

Early morning fasting reading (if applicable) ………… Screening reading………..Time since last meal …………….Follow-up:

Body Mass Index (BMI) and waist circumference measurements

The body mass index (BMI) is a risk factor for cardiovascular disease and diabetes. It is considered normal if the score is below 25. Overweight is associated with a value between 25 and 29.9, whereas obese is a value greater than 30. The BMI is determined as a ratio between weight and height2. Waist circumference measurements regarded as normal are less than 80/94cm female/male whilst measurements above 90/102cm female/male are regarded as indicative of substantially increased risk to health.

BMI Result: kg/m2 Waist circumference cmFollow-up:

Ankle-Brachial-Index (ABI)

The ABI is a measure that compares the blood pressure in the arm with that in the leg. As such it is an indicator of how well blood moves down into the legs.

Result of ABI- Right side:Left side:

The normal range for ABI is between 0.9 and 1.3. ABI follow up:

Peripheral Neuropathy

We also tested for how well the sensory nervous system functions in the foot. Clinical significance is considered when bilateral changes are evident or 2 or more of the tests show changes indicative of decreased function.

Monofilament:Vibration:Reflexes:Muscle tone:

Follow – up:

Autonomic Nervous System Assessment:

Assessment of your Autonomic Nervous System is:Blood Pressure:a) Lying (average of two readings) - Systolic: Diastolic:b) Standing at 2 minutes - Systolic: Diastolic: c) Difference: Systolic:……….. Diastolic:…………..

A blood pressure of 120/80 is normal but can be up to 140/90. Please note if there is a drop of systolic blood pressure on standing greater than 30 mmHg or diastolic pressure greater than 15 mmHg, then this may be due to antihypertensive medication or a sign of postural hypotension.

Follow-up:

ECG Assessment: (trace of 10sec ECG provided)

Assessment of your ECG has indicated: see interpretation on ECG trace……………………………………………………………………………………………………...………………………………………………………………………………………………………

Note: It is not uncommon for healthy people to show some anomaly to normal sinus rhythm on their ECG trace due to aging or because they are sports active, slim or large. Most often we see left ventricular hypertrophy and bradycardia in ECG traces. However, these findings are often associated with fitness. Left axis deviation is also often seen and is in some cases a marker of heart disease. It is clinically not significant in the majority of people.If any of your results indicate some clinically significant abnormality, we recommend that you visit your general practitioner for a check up.

We would also appreciate if you could write us a letter letting us know of what you thought of the diabetes screening clinic you attended and any further outcomes from follow-up with your general practitioner.

If you have any further questions or comments you can contact Herbert Jelinek on 02 60516946 With thanks from the Diabetes Research Group.

Herbert Jelinek. PhD Clinical EducatorCoordinator Name:Diabetes Complications Screening & Research Signature:

Charles Sturt University Participant Code………….

Diabetes Screening Session - Stations.

STATION 1. tick or n/a [ ] Consent form completed

[ ] Health/Foot Questionnaire (new clients only)

[ ] Recent GP Pathology done

[ ] Autonomic Nervous System Function test.

Signed…………………………………

STATION 2. FOLLOW UP BY D.E. [ ]Diabetes: Type I [ ] Type II [ ] N.D. [ ]Early morning glucose ……………… mmol/L Time since last meal ………………hrsClinic Glucose Test………………. mmol/LWaist circumference………………..cmHeight…………m Weight……………kgBMI…………………(W/h2 ; kg/m2)

Signed…………………………………

STATION 3. FOLLOW UP [ ]NeuropathyMonofilament L [ ] R [ ]Muscle L [ ] R [ ] Vibration L [ ] R [ ]Reflex ankle L [ ] R [ ]Reflex knee L [ ] R [ ]wnl = within normal limits, p = present, a = absentr = reducedSigned…………………………………

STATION 4. FOLLOW UP [ ]A.B.I. R. arm……/………R. leg……/…….R.ABI…………

L. arm……/……….L. leg……/……..L.ABI…………

Average ABI……….

Signed…………………………………

STATION 5. FOLLOW UP [ ]3 lead ECG Test - (SL) / 20min / (LS)Skin sensitivity yes [ ] no [ ]Dizziness upon rising yes [ ] no [ ]ANS test done: deep breathing yes [ ] no [ ] Valsalva yes [ ] no [ ] Hand grip yes [ ] no [ ] LS / SL yes [ ] no [ ] Signed…………………………………

STATION 6. FOLLOW UP [ ]Eye Test.epilepsy?Last eye test …………………………………….Eye problems/history (glaucoma, cataracts, D.R.)…………………………….……………………………………………………

Signed…………………………………

STATION 7A. FOLLOW UP [ ]12 lead ECG Test

Skin sensitivity yes [ ] no [ ]Previous heart problem………………………Chest pain …………………………………...

Signed…………………………………

STATION 7B. FOLLOW UP [ ] Lying to Standing B. P. Lying 1………/… Lying 2………/… Standing 1(1 min)………/.. Standing 2(3 min)………./.Dizziness upon rising yes [ ] no [ ]

Signed…………………………………

REFERALS IMMEDIATE RECOMMENDED NOT REQUIREDDIABETES [ ] [ ] [ ]PODIATRY [ ] [ ] [ ]BLOOD PRESSURE [ ] [ ] [ ]ECG [ ] [ ] [ ]BMI [ ] [ ] [ ]

Station Requirements:

Podiatry 1 Doppler 1 aneroid sphygmomanometer 1 stethoscope 1 tube ultrasound gel Calculator

1 Reflex hammer 1 Monofilament 1 Vibration tuning fork Gloves Tissues Rubbish bags

Extra requirement: 1 pillow Viraclean solution Rubbish bin

3 Lead ECG Red dot electrodes 3M 2560 Kimwipes Micropore Razors Stopwatch Spare rubbish bags Sharps container Extra requirements: 2 pillows 1 blanket or sheet 1 rubbish bin

12 Lead ECG Laptop computer HP Printer Cardiocontrol unit incl unilink cable & leads Electrodes (red dot 3M2330) Printer cables Power board 4 port USB2 Razors (single use) Isowipes Micropore tape Timer Sharps container Tissues Sphygmomanometer aneroid Stethoscope 9V battery printer cartridge HP27

Extras printer paper 2 pillows 1 blanket 1 rubbish bin

Pathology Request Forms

Dorovitch Release Form

Dorovitch PathologyUnit 1/2 Ramsay Place Albury West 2640

22/02/06

To whom it may concern,

The Charles Sturt University, School of Community Health has been investigating cardiovascular complications associated with diabetes.

The attached people have been participating in our research.They have indicated to us that they have had pathology tests in the last 12 months and have given consent for their results to be released to us.

Would you please forward on copies of routine chemistry, (plasma and urine) HbA1c, Lipids and Homocysteine reports if available that these patients have had since February 2005.

Please forward results to Sharon Newbold School of Community Health Charles Sturt University Albury.

Yours truly,

Bev deJong (60516858)For Dr H JelinekDiabetes ComplicationsResearch Coordinator Ph 60516946

South West Pathology Release Form

South West Pathology Service590 Smollett StAlbury 2640

23/02/06

To whom it may concern,

The Charles Sturt University, School of Community Health has been investigating cardiovascular complications associated with diabetes.

The attached people have been participating in our research.They have indicated to us that they have had pathology tests in the last 12 months and have given consent for their results to be released to us.

Would you please forward on copies of routine chemistry, (plasma and urine) HbA1c, Lipids and Homocysteine reports if available that these patients have had since February 2005.

Please forward results to Sharon Newbold School of Community Health Charles Sturt University Albury.

Yours truly,

Bev deJong (60516858)For Dr H JelinekDiabetes ComplicationsResearch Coordinator Ph 60516946

Insurance

ECG Analysis

12-lead ECG classification

Class 1a Class 1b Class 2a Class 2b Class 3Sinus rhythm

Left ventricular hypertrophy

1 heart bock Q waves in more than 1 lead

Atrial Fibrillation

Sinus arrhythmia

Notched or enlarged P wave(P mitrale/P pulmonale

Extensive Inverted T waves

Ventricular fibrillation

Slow rhythm (50 > HR < 60)

Peaked T waves Prolonged QT interval

Left bundle branch block

Conduction delay of atrial or ventricular origin

PVC and PAC Bigeminy or trigeminy

2 Degree heart block type 2

Left or right axis deviation

Multifocal PVC or PAC

Atrial flutter

Q waves indicating old infarct

Right Bundle Branch Block

2 Degree heart block type 1

Paroxysmal supraventricular tachycardia

Left anterior fascicular block (LAFB)

ST elevation in > 2 lead

Ventricular tachycardia

Right anterior fascicular block (RAFB)

Tachycardia 100 > HR < 120

Complete atrio ventricular block

ST depression with LVH

Bradycardia < 50 HR

Left Bundle Branch Block

ST elevation in more than 2 leads

Analysing HR Intervals with Chart 5

Select SET UPCHANNEL SETTINGS

NUMBER OF CHANNELS = 1OK

Select HRVANALYSIS SETTINGS

CLICK R WAVE DETECTION…..opens R Wave detection Settings Check threshold Enter value = 0.05

This will insert a line into the graph, hold pointer over horizontal line then click and drag to a point above the highest T

wave but below the lowest R wave

Check Post event sleep Enter value = 0.1 OKOK (to close boxes)

Select HRVCALCULATEEach beat shall now have a value for HRV in ms

Click on (-) button (bottom left corner) until trace is easily viewedClick on small trace button on bottom RHS horizontal bar until relevant sections of trace are in view (ie pre / post marker line for changed status)Highlight section to be analysed by clicking and dragging around area

Open DATA PAD by clicking Show Data Pad button (8th) or select from WINDOW menu

Click on heading A (Data Pad Column A Setup)Select CYCLE VARIABLES

MINIMUM PERIODCHANNEL 1

OKClick on heading B (Data Pad Column B Setup)

Select CYCLE VARIABLESMAXIMUM PERIOD

CHANNEL 1OK

RECORD RESULTS

Downloading Files from Mac Computers

Insert formatted floppy disk to computer Open “untitled” file on desktop Open saved files – ie DS OCT 06The saved files should be in *.adicht format (if not open in Chart program and resave as a ‘chart for windows’ OR ‘Chart (win) data’ file

Click and drag saved file into untitled window

When disk is full drag down to the Trash to enable removal of disk

Save in S:\Academic\Health Studies\Community Health\BMS\community of scholars\HRV\2006

Create folders ie ds oct 06 within which are: va oct 06 dsdb oct 06 dsls oct 06 dssl oct 06 ds

copy traces into relevant folders by opening explorer with FOLDERS selected: click and drag files across

Retinal Analysis

Digital Health Care Software and Camera Loading on to PC

INSTALL DH CLIENT SOFTWARESECRET LOGIN XPASSWORD X.X ALL UPPERCASE!

INSTALL EOS CAMERA DRIVER: EOS DIGITAL SOLUTION DISKDESELECT EVERYTHING EXCEPT DRIVER

INSTALL

OPEN MY COMPUTERSELECT CAMERA ICON

RIGHT CLICK TO OPEN PROPERTIESCLICK ON “TAKE NO ACTION“

OPEN DH CLIENTCONFIGURE

CANON CR DGICANON DIGITAL CAMERACANON EOS CAMERAAPPLY OK

SYSTEM CONFIGUREUPPERCASE: RAIN.BOW OK

IMAGE SELECT AN IMAGE TYPE ie JPG OR TIFOK

CONFIGUREDIRECT & ARCHIVING

MAIN DB PATH NUMBER OF COPIES 1SHOW UNARCHIVED VISITS YES

QUIT

TO REDIRECT FROM D:/ TO EXTERNAL HARD DRIVE:

DIRECT & ARCHIVINGARCHIVE DEVICE: DISKDISK ARCHIVE PATH 1: CLICK TO OPEN BROWSER

SELECT EXTERNAL HD ***EXTERNAL HD MUST BE DIRECT TO PC

LOGGIN ON REQUIRED - NOQUIT

CAMERA STATEJPEG – LARGE/FINEWHITE BALANCE - DAYLIGHTKELVIN 5400ISO 400SHUTTER 1/60

Non- Mydriatic Camera

SETTINGS TO REVIEW PHOTOS WITHOUT CAMERA ATTACHED

Computer ON DH Client selected with Cameras off screen displayed –

Select canon camera frame - noneframe grabber not detected – okUSER OPTIONS:

Reset frame grabber, instrument type & video camera type to NONEApplyOK

Next – review patients

TO RE SET: TURN ON COMPUTER, WHEN READY TURN ON CAMERAS

Open programIdentify Patient Sheet – select Configure then User Options

Re assign:Frame grabber: Cannon EOS 30DInstrument type: Cannon CR-DGiVideo camera type: Canon Digital camera

ApplyOK

Saving Digital Eye Data as JPG Files

When photo session is completed for a participant save all photos into a file labelled EYE jpg_DATE (create this file if necessary):

All photographs for the participant’s session should be in view

Click on photo 1 (shall be highlighted with pink outline)

Select ‘VIEW FULL SIZE’ (one click only) from the “CONTACT STRIP” drop down menu

A full screen view of the image now appears

Select “SAVE IMAGE ON DISC” from the “VIEW IMAGE” drop down menu

Select pathway – DESKTOP / EYE jpg_DATE

Save file as PARTICIPANT CODE_DATE_1 ie KOLC220253_020707_1 (number corresponds to photograph number)

Select “QUIT”

View will return to all participant photos

Click once on photo 1 (etc) to deselect then click on next photo and repeat the above instructions until all photos are saved