aclinical care!audit!tool!(ccat)!for! australianoptometrists:!! · 2015-05-13 ·...

A Clinical Care Audit Tool (CCAT) for Australian optometrists:

assessing the quality of primary eye care provided to patients with diabetes

Dr Laura Downie BOptom, PhD(Melb), PGCertOcTher, FACO, FAAO, DipMus(Prac), AMusA

Lecturer, NHMRC Translating Research Into Practice (TRIP) Fellow

A/Prof Peter Keller BAppScOptom, PhD, PGCertOcTher, MBA, MHEth

Honorary Principal Fellow

Department of Optometry and Vision Sciences

School of Health Sciences The University of Melbourne

This work was supported a 2015 Victorian Optometrists Training and Education (VOTE) grant.

A clinical care audit tool (CCAT) for Australian Optometrists – Dr Laura E Downie, A/Prof Peter R Keller Department of Optometry and Vision Sciences, The University of Melbourne Version 1.0, 10 May 2015, © Copyright 2015.

1

BACKGROUND What is clinical audit? Clinical audit is commonly defined as a “quality improvement process that seeks to improve patient care and outcomes through systematic review against explicit criteria and the implementation of change” (National Institute for Health and Clinical Excellence, 2002). In simple terms, a clinical audit involves finding out whether current care practices are appropriate, and identifying any potential shortfalls in patient care. It allows clinicians to assess whether they are adopting best practices, as defined by high-‐quality clinical research. The ultimate aim of a clinical audit is to improve the provision of patient care. This optometric clinical care audit tool (CCAT) is designed to enable Australian optometrists to compare their eye care practices for patients with diabetes against current evidence-‐based standards (being the National Health and Medical Research Council (NHMRC) guideline for the Management of Diabetic Retinopathy, 2008), and where indicated, modify their practices to enhance the quality and outcomes of optometric patient care to patients with diabetes. Why is clinical audit important? There are numerous reasons why clinical audit is important. One of the main reasons is that it helps to improve the quality of the service being offered/provided. Without some form of clinical audit it can be difficult to know whether a practitioner is practicing effectively and even more difficult to demonstrate this to others. The benefits of clinical audit are that it:

• identifies and promotes good clinical practice and can lead to improvements in service delivery and outcomes for patients

• can provide the information practitioners (or professions) need to show others that a service is effective (and cost-‐effective)

• provides opportunities for training and education • helps in the better sue of resources, and therefore, increased efficiency • can improve working relationships communication and liaison between staff, staff and

patients, and between agencies. What to audit? Clinical audit can cover one or more of several different aspects of clinical care or service provision. Several ways of subdividing clinical audit topics have been devices and a useful framework uses three topic headings:

• Structure The availability and organisation of resources and personnel • Process The activities undertaken, i.e., what is done • Outcome The effect of the activities on the health and well-‐being of patients.


2

How to perform a clinical audit: the audit cycle There are eight key steps in a clinical audit cycle; these are summarised in Figure 1. Once the final step is complete, the audit cycle should begin again; this is the process of re-‐auditing.

Figure 1-‐ The clinical audit cycle

Step 1. Select a topic Typically, a suitable topic for a clinical audit will involve the assessment of whether a certain aspect of clinical care (or a process relating to clinical care) is adhering to established best-‐practice standards. As the undertaking of a clinical audit requires an investment in time and resources, the chosen topic should be important; a topic may be of priority for a range of reasons, including the risk of vision loss with poor patient management, patient complaints in an area of practice or a high volume of patients with the condition of interest. The undertaking of an audit is facilitated by the availability of best-‐practice standards (e.g., systematic review, national clinical guidelines). This optometric CCAT is designed for optometrists to undertake a local audit project of their own practices in relation to the ocular primary care provided to patients with diabetes. This can be regarded as a part of quality improvement, to identify practices that can be improved or where current practices are uncertain. Step 2. Identify best practice The next step is to identify what aspects of best practice should be included in the audit. For this audit, the NHMRC Guidelines for the Management of Diabetic Retinopathy (2008) are currently considered as best practice.


3

Step 3. Agree upon criteria and standards Criteria define good practice in the aspects of care under examination. An example of a criterion for this audit is the undertaking of a posterior ocular examination through a dilated pupil using indirect ophthalmoscopy, as specified in the NHMRC Guidelines. Standards define expected levels of success and are typically expressed as percentages. A relevant standard for the previously defined criterion, would be that 100 percent of posterior ocular examinations in patients with diabetes are undertaken using the procedures defined in the NHMRC Guidelines (i.e., through dilated pupils, using indirect ophthalmoscopy). Step 4. Collect data The purpose of data collection is to determine whether, in the practice undergoing audit, the agreed criteria and standards are being achieved. The collected data should be relevant, accurate and representative. Data collection can be performed manually or using electronic software. This CCAT is designed to streamline the process of data collection for you. Step 5. Analyse data Data analysis involves the interpretation of the collected audit data to assess how current practice compares with the agreed criteria and standards. This step is important for identifying any potential areas of under-‐performance; these areas should be reviewed in detail to identify why care falls below the desired levels and how it can be improved. Data analysis also enables the identification of areas of strengths and high performance. To assist you with analysing your audit data, this CCAT has been designed with a self-‐populating ‘Summary statistics’ worksheet and bar chart, which provides a summary of the key features of your clinical audit. Step 6: Implement changes Implementing changes to improve any identified areas of under-‐performance (e.g., staff training, introduction of better systems of practice, familiarity with guidelines, etc.) is one of the most important steps in an audit project. This step is critical for quality improvement. Step 7: Re-‐audit Re-‐auditing should be carried out within one year of implementing changes to improve practice. This process involves collecting a second set of data to review progress after the changes been implemented; this enables you to identify whether further improvement is needed. The number of patients audited should ideally be comparable to those from the first data collection phase. Step 8: Report findings You should create a permanent record of your audit findings. You can share this with the colleagues that you practice with, particularly if they have been involved in implementing changes, so that you can demonstrate the effects that the audit has had on your practice.


4

PREPARING FOR YOUR CLINICAL AUDIT This optometric clinical care audit tool (CCAT) is designed to enable you to specifically audit your clinical practices in relation to the eye care you provide to patients with diabetes mellitus. The CCAT also provides a framework for you to consider auditing your clinical practices for other eye diseases. A clinical audit is a type of cross-‐sectional study that allows you to analyse a range of different aspects of the patient care you have provided; typical features to analysis include the demographics of the patients that came to see you for their eye care, what clinical procedures you undertook and whether these were appropriate, the accuracy of any diagnoses you made in relation to diabetic retinopathy, your patient management decisions and whether your patients followed your care recommendations. (i) Essential infrastructure You will need:

-‐ to use Microsoft Excel for data entry into the CCAT; data should be entered directly into the CCAT spreadsheet. We do not recommend printing out the CCAT and inputting data into a hard copy as this may result in transcription errors and does not fully utilise the in-‐built features of the CCAT (e.g., drop-‐down menus, self-‐populating cells). Separate Microsoft Excel CCAT spreadsheets are available for PC and Mac;

-‐ direct access to your patient clinical records; -‐ NHMRC Guidelines for the Management of Diabetic Retinopathy (2008) -‐ time to input the data for each patient into the CCAT.

(ii) Type of audit First, you need to decide whether you intend to conduct a retrospective or prospective clinical audit. Most clinical audits are undertaken retrospectively; this involves implementing an audit where you analyse existing patient data. An alternative is to prospectively design an audit system, which enables future patient data to be analysed. (iii) Audit period Next, you need to decide upon the time period for your clinical audit. We suggest that you consider a 12-‐month audit period initially (e.g., 1st January 2014 to 1st January 2015); this time period should be feasible for most practitioners to undertake, without requiring a significant investment in resources. This audit period should allow you to assess the accuracy of your diagnosis and management strategies for patients with diabetes. An alternative, and potentially more informative strategy, would involve a longer audit period (e.g., three years). This longer duration audit will enable you to capture information about your patient’s behaviours (e.g., for patients who were recommended to have a biennial review, did they attend within this time?). Clearly, the longer the audit period, the more patient records that would potentially need to be examined, which requires a larger time investment. (iv) Identification of relevant patient records After you have decided on an audit period, you need to begin the process of identifying relevant patient records for your clinical audit. For this audit, relating to diabetic retinopathy, you should seek to identify all patients with potential clinical signs of diabetes. How you approach this task will vary depending upon whether your practice uses paper or electronic records, and whether you currently use any ‘coding’ systems to categorise patients.


5

For practices using paper patient records, the identification of relevant records would typically require the manual retrieval and inspection of each record (over the designated audit period) for keywords (please see section (v) below); this task may be undertaken by you, or a suitably trained member of your support staff. For practices using electronic records, identifying relevant patient records may depend upon the features of your practice management software and whether or not you have been using a keyword coding system. If you are able to undertake an automated ‘keyword’ search through your electronic records (please see section (v) below); this should facilitate a fairly rapid identification of potentially relevant records. If this function is not available, a manual inspection of each electronic record may be necessitated. (v) Suggested keywords To assist you in identifying potentially relevant patient records for this clinical audit, we have developed a list of suggested keywords, which relate to terms that may appear both in the clinical history and examination sections of the patient records. Clinical history: diabet*, blood glucose, insulin, metformin, HbA1c, glucose, DM, type I,

type II, IDDM, NIDDM Clinical examination: microaneurysm, MA, macular oedema, DME, CSME, retinopathy,

haemorrhage, haem, dot, blot, cotton wool, CWS, CWP, hard exudate, exudate, HEx, venous beading, IRMA, lipid, neovasc*, non-‐proliferative, proliferative, NPDR, PDR, PRP, pan-‐retinal, laser

Patient records that are identified to have one, or more, of these keywords should then be manually evaluated with regard to eligibility for inclusion in the audit. All patients with diabetes, or suspected diabetes, should be included.


6

GENERAL DEFINITIONS AND FORMATTING REQUIREMENTS FOR CCAT DATA ENTRY General definitions Blood glucose For the purpose of this CCAT, a ‘blood glucose’ measure is defined as the

patient’s self-‐performed, daily blood glucose reading; this information is captured in the CCAT ‘DR risk factors’ worksheet.

Clinically significant CSME is defined as retinal thickening within 500µm of the foveal centre, OR macular oedema hard exudates (HEx) within 500µm of the fovea with adjacent retinal (CSME) thickening. Comprehensive visit For this CCAT, a ‘comprehensive visit’ is defined as when the clinician

considers a full eye examination (as appropriate for a patient with diabetes) to have been undertaken. A ‘comprehensive visit’ may therefore have taken place over one, or more, physical patient visits. If a ‘comprehensive visit’ was considered performed over two or more visits, the ‘date’ of the first comprehensive visit should be recorded as the date that the last components of the comprehensive visit were performed (i.e., when the assessment was complete) in the ‘Visits’ worksheet.

Diabetic macular DME is defined as retinal thickening within 1DD radius of the fovea and can oedema occur with any stage of DR. Please also see ‘clinically significant macular

oedema’ (CSME). Diabetic retinopathy Diabetic retinopathy (DR) is defined as the presence of typical microvascular

signs in a person with diabetes; these signs are non-‐specific and may also be seen in people without diabetes.

DR can be sub-‐categorised as non-‐proliferative (NPDR), previously termed

‘background’ retinopathy, which may evolve to proliferative retinopathy (PDR). PDR is characterised by the growth of abnormal new vessels either at the optic disc (NVD) or elsewhere (NVE) within the retina.

‘High risk’ patient Based upon the NHMRC Guidelines for the Management of Diabetic

Retinopathy (2008), a patient at ‘high risk’ for diabetic retinopathy has one, or more of the following risk factors:

-‐ longer duration of diabetes -‐ poor glycaemic control -‐ inadequately controlled systemic hypertension -‐ inadequately controlled hyperlipidaemia -‐ Indigenous or Torres Strait Islander -‐ non-‐English speaking background

(this definition is relevant to the CCAT ‘Management’ worksheet) ‘Patient’s impression’ Refers to the patient’s perceived impression of their level of of hyperglycaemic hyperglycaemic control, in the absence of quantitative control information such as HbA1c or daily blood glucose readings (to be captured

into the CCAT ‘DR risk factors’ worksheet). ‘Type’ of diabetes Refers to the description of type I versus type II diabetes mellitus, or insulin-‐

dependent (IDDM) versus non-‐insulin-‐dependent diabetes mellitus (NIDDM), which is to be captured in the CCAT ‘DR risk factors’ worksheet). For further


7

explanation of these definitions, please also refer to page 22 of the NHMRC Guidelines for the Management of Diabetic Retinopathy.

Formatting requirements: Date format Dates should be entered in the following format: DD.MM.YYYY


8

LIST OF ABBREVIATIONS BCVA Best-‐corrected visual acuity CCAT Clinical care audit tool CSME Clinically significant macular oedema CWP Cotton wool patch CWS Cotton wool spot DD Disc diameter DFE Dilated (ocular) fundus examination DME Diabetic macular oedema DOB Date of birth DR Diabetic retinopathy Dx Diagnosis (of the patient’s condition) FH Family history GP General medical practitioner Haem Haemorrhage (retinal) HbA1c Glycosylated haemoglobin HEx Hard exudates IDDM Insulin-‐dependent diabetes mellitus IRMA Intra-‐retinal microvascular anomalies MA Microaneurysm Mx Management (of the patient’s condition) NHMRC National Health & Medical Research Council of Australia NIDDM Non-‐insulin dependent diabetes mellitus NPDR Non-‐proliferative diabetic retinopathy NVD Neovascularisation (retinal) on the disc NVE Neovascularisation (retinal) elsewhere OCT Optical coherence tomography PDR Proliferative diabetic retinopathy PRP Pan-‐retinal photocoagulation Px Patient VA Visual acuity


9

ENTERING DATA INTO THE CCAT Overview The CCAT Excel spreadsheet consists of eight separate worksheets. You will need to input data into seven of these worksheets, as follows:

1. ‘Visits’ worksheet: audit time period and patient visit schedule 2. ‘General patient info’ worksheet: patient demographics 3. ‘DR risks factors’ worksheet: identification of risk factors for diabetic retinopathy 4. ‘Essential exam procedures’ worksheet: ‘essential’ clinical examination procedures for

assessing for diabetic retinopathy 5. ‘Other exam procedures’ worksheet: other ocular examination procedures, considered

relevant for the ophthalmic examination of patients with diabetes, 6. ‘Clinical findings and diagnosis’ worksheet: clinical signs of diabetic retinopathy noted on

each patient record and recording of severity of any retinopathy or macula oedema 7. ‘Management’ worksheet: assessment of the adherence of the management approach to the

NHMRC Guidelines for the Management of Diabetic Retinopathy (2008) The final worksheet, ‘Summary statistics’, is a fully self-‐populating page and chart that provides a summary of the key features of your clinical audit.


10

1. ‘Visits’ worksheet: Audit time period and patient visit schedule Overview: The ‘Visits’ worksheet (Figure 2) provides a summary of the patient records to be included in the clinical audit, and the date(s) each patient underwent a comprehensive eye examination during the audit period.

Figure 2. Layout of CCAT ‘Visits’ worksheet

Instructions for use: Audit period: Enter the start date (in D1) and end date (in F1) for your audit, in the format

of: DD.MM.YYYY e.g., 01.01.2014 to 01.01.2015 Patient reference: In Column A, enter a unique identifier for each patient to be evaluated in the

audit; this can be in words/numbers or a combination of both (e.g., record ID, patient initials).

e.g., 43007 The CCAT enables up to 100 individual patients to be entered; if more than

100 patients are to be audited, we recommend using a second Excel spreadsheet for the additional patients.

Visits: Enter the date of each ‘comprehensive’ visit for each patient within the audit

period (for a definition of ‘comprehensive visit’ please refer to the ‘general definition and formatting requirements’ information, page 6). The visit schedule is currently configured to enable the details of up to four comprehensive visits to be assessed within the designed audit period.

e.g., 01.04.2014 (for a patient that had one comprehensive visit within the audit period)

If more reviews than this were performed within the audit period, we would recommend using a second Excel spreadsheet to capture this information.


11

2. ‘General Px info’ worksheet: patient demographics Overview: The ‘General Px info’ worksheet (Figure 3) provides a summary of whether essential general information about each patient was captured on the patient’s record.

Figure 3. Layout of CCAT ‘General Px info’ worksheet

Instructions for use: The ‘patient reference’ (column A) will have automatically populated into this worksheet from the ‘Visits’ worksheet; you do not need to enter this information. e.g., 43007 appears in A4 For each of the information categories listed in Table 1, use the drop-‐down menu in the appropriate cell to indicate whether this information was captured on each patient record:

Table 1. Summary of general patient information categories Information type Patient record details

(Were the following details recorded?) Response options*

Age Date of birth Yes/No Gender Sex Yes/No Ethnicity Race / ethnic heritage Yes/No Medical practitioners involved in the patient’s care

General medical practitioner Endocrinologist Renal specialist

Yes/No Yes/No/Not applicable Yes/No/Not applicable

* If the patient record is ambiguous, then ‘No’ should be selected. ‘Not applicable’ should only be selected if it is clear from the record that the patient does not have an endocrinologist or renal specialist, otherwise ‘No’ should be selected. Each ‘Yes’ response will automatically appear with a green highlight within the cell. Each ‘No’ response will automatically appear with a red highlight within the cell. ‘Not applicable’ responses will show no change in background colour.


12

3. ‘DR risk factors’ worksheet: Overview: The ‘DR risk factors’ worksheet (Figure 4) provides a summary relating to whether key information about established risk factors for diabetic retinopathy (DR) were captured on each patient record.

Figure 4. Layout of CCAT ‘DR risk factors’ worksheet

Instructions for use: The ‘patient reference’ (column A) will have automatically populated into this worksheet from the ‘Visits’ worksheet; you do not need to enter this information. e.g., 43007 automatically appears in A4 through to A7 The date for each comprehensive visit (columns B to E), will also have automatically populated from the data you entered in the ‘Visits’ worksheet; if you entered fewer then four visits, the cells corresponding to the visits that are not applicable to that patient will appear black. e.g., 01.04.2014 automatically appears in B4 For each of the information categories listed in Table 2, you should use the drop-‐down menu in the appropriate cell to indicate whether this information was captured on each patient record. Each ‘Yes’ response will automatically appear with a green highlight within the cell. Each ‘No’ response will automatically appear with a red highlight within the cell.


13

Table 2. Summary of the key risk factors for diabetic retinopathy (DR) (based upon the NHMRC Guidelines for the Management of Diabetic Retinopathy, 2008)

Risk factor Association with DR and suggested targets

Patient record details (Were the following details recorded?)

Response options*

Duration of diabetes

• duration of diabetes is the strongest (and a non-‐modifiable) risk factor for DR

• Type of diabetes • Duration of diabetes • Diabetes medications

Yes/No Yes/No Yes/No

Hyperglycaemic control

• any lowering of HbA1c reduces the development and progression of DR

• for patients with DR, target HbA1c should be ≤ 7.0% (“optimal glycaemic control”)

• HbA1c • Blood glucose (daily)# • Patient’s impression#

Yes/No Yes/No Yes/No

Systemic hypertension

• any lowering of blood pressure (BP) reduces the development and progression of DR

• For patients with DR, target systolic BP should be <130mmHg

• Systemic blood pressure

• Hypertension medications

Yes/No Yes/No

Systemic lipids status

• for patients with DR, target LDL cholesterol of < 2.5 mmol/L and triglycerides of < 2.0 mmol/La

• Blood lipid levels • Hyperlipidaemia

medications

Yes/No Yes/No

Pregnancy status • highest risk of DR in pregnancy with diabetes > 15 years duration, poor glycaemic control and hypertension

• Pregnancy status Yes/No/Not applicable

Genetic risk factors (various candidate genes identified)

• may regulate the severity and rapidity of the onset of DR

• Family history of diabetes

Yes/No

a National Evidence Based Guidelines for the Management of type 2 diabetes mellitus: Part 7 – lipid control in type diabetes, NHMRC 2004 * In any cases where the patient record is ambiguous, then ‘No’ should be selected. # For definitions of these categories, refer to the ‘General Definitions’ section


14

4. ‘Essential exam procedures’ worksheet: Overview: The ‘Essential exam procedures’ worksheet (Figure 5) provides a summary of whether key ocular examination procedures, to assess for diabetic retinopathy, were performed, for both eyes, at each comprehensive visit.

Figure 5. Layout of CCAT ‘Essential exam procedures’ worksheet

Instructions for use: The ‘patient reference’ (column A) will have automatically populated into this worksheet from the ‘Visits’ worksheet; you do not need to enter this information. e.g., 43007 appears in A4 through to A7. The date for each comprehensive visit (columns B to E), will also have automatically populated from the data you entered in the ‘Visits’ worksheet; if you entered fewer then four visits, the cells corresponding to the visits that are not applicable to that patient will appear black. e.g., 01.04.2014 automatically appears in B4 For each of the information categories in Table 3, you should use the drop-‐down menu in the appropriate cell to indicate whether this information was captured on each patient record. Each ‘Yes’ response will automatically appear with a green highlight within the cell. Each ‘No’ response will automatically appear with a red highlight within the cell. ‘Not applicable’ responses will show no change in background colour.


15

Table 3. Summary of essential ophthalmic examination procedures for DR (based upon the NHMRC Guidelines for the Management of Diabetic Retinopathy, 2008)

Procedure Measurement protocol Patient record details (Were the results for these tests recorded?)

Response options*

Visual acuity (VA)1

• Distance VA, monocularly in both eyes

• Pinhole (upon indication)

• VA (R&L) • Pinhole (if

applicable)2

Yes/No Yes/No/Not applicable

Slit lamp biomicroscopy

• Specific assessment for: o iris neovascularisation

• S/L -‐ no abnormalities (or similar)

Yes/No

Posterior ocular examination

• Various examination methods are considered

• Any exam3? • DFE4? • Indirect

ophthalmoscopy5? • If no DFE was

performed, explain why.6

Yes/No Yes/No Yes/No Open-‐ended text field

* In any cases where the patient record is ambiguous, then ‘No’ should be selected. 1 For Visit 1, visual acuity is defines as best-‐corrected spectacle VA. For subsequent visits, habitual VA may be appropriate if there is no change in acuity. 2 Pinhole acuity would only need to be measured upon indication (e.g., unexplained reduction in best-‐corrected VA). 3 Any exam?, is defined as any posterior ocular examination performed by an optometrist, using ANY method (e.g., direct ophthalmoscopy, indirect ophthalmoscopy), with or without pupil dilation. If only fundus photography, without physical assessment of the posterior eye by the optometrist, was performed, the response should be ‘No’. 4 DFE?, is considered to be a dilated ocular fundus examination (DFE), involving posterior ocular examination through a dilated pupil, where pupil dilation is achieved using 0.5% to 1.0% topical tropicamide; 2.5% topical phenylephrine hydrochloride, unless contraindicated, may also assist with achieving maximum pupil dilation (particular in patients with heavy iris pigmentation) 5 Indirect ophthalmoscopy is defined as posterior ocular examination with the slit lamp and an appropriate fundus lens, or BIO with an appropriate fundus lens. 6 If no DFE was performed, the expected reason for this should be entered into the open-‐ended text field (e.g., patient did not attend for review appointment, anterior chamber angles were deemed to narrow and patient referral for ophthalmologic opinion was initiated)


16

5. ‘Other exam procedures’ worksheet: Overview: The ‘Other exam procedures’ worksheet (Figure 6) provides a summary of whether other ocular examination procedures, considered relevant for the ophthalmic examination of patients with diabetes, were performed, for both eyes, at each comprehensive visit.

Figure 6. Layout of CCAT ‘Other exam procedures’ worksheet

Instructions for use: The ‘patient reference’ (column A) will have automatically populated into this worksheet from the ‘Visits’ worksheet; you do not need to enter this information. e.g., 43007 appears in A4 through to A7. The date for each comprehensive visit (columns B to E), will also have automatically populated from the data you entered in the ‘Visits’ worksheet; if you entered fewer then four visits, the cells corresponding to the visits that are not applicable to that patient will appear black. e.g., 01.04.2014 automatically appears in B4 For each of the information categories in Table 4, you should use the drop-‐down menu in the appropriate cell to indicate whether this information was captured on each patient record.


17

Table 4. Summary of other recommended ophthalmic examination procedures for examining patients with diabetes

Procedure Patient record details (Were the results for these tests recorded?)

Response options*

Pupil responses • Direct (D) and Consensual (C) • Near

Yes/No Yes/No

Ocular motility • Extent, fluency and symmetry of eye movements (actively ruling out eye movement anomalies)

• Assessment of eye alignment (e.g., cover test and prism)

Yes/No Yes/No

Visual field screening

• Confrontation visual field • Amsler grid test

Yes/No Yes/No

Refraction and visual acuity

• Refraction and VA measured upon indication (e.g., change in vision or visual acuity noted)

Yes/No/Not applicable

Tonometry • Intra-‐ocular pressure (R&L), time of measurement, method of measurement

Yes/No

Gonioscopy • Gonioscopic evaluation of the anterior chamber angle

Yes/No

Retinal fundus photograph

• Any form of retinal fundus photo Yes/No

Macular OCT • Any type of macular optical coherence tomography (OCT) scan

Yes/No

Macular function test

• Any type of specific macular function test (e.g., 10-‐2 visual field, photostress test, etc.)

• Name of test

Yes/No Open-‐ended text field

Other testing • Name of test (e.g., dark adaptation) Open-‐ended text field * In any cases where the patient record is ambiguous, then ‘No’ should be selected. ‘Not applicable’ should only be used when the procedure was not indicated.


18

6. ‘Clinical findings and diagnosis’ worksheet: Overview: The ‘Clinical findings and diagnosis’ worksheet (Figures 7 and 8) provides a summary of the clinical signs, relevant to assessing for DR, that were noted in each eye at each comprehensive visit. Instructions for use: Unlike previous worksheets, this worksheet provides one row for each eye (rather than one row for each patient). The ‘patient reference’ (column A) will have automatically populated into this worksheet from the ‘Visits’ worksheet; you do not need to enter this information. e.g., 43007 appears in A5 through to A12. The date for each comprehensive visit (columns B to E), will also have automatically populated from the data you entered in the ‘Visits’ worksheet; if you entered fewer then four visits, the cells corresponding to the visits that are not applicable to that patient will appear black. e.g., 01.04.2014 automatically appears in B5 and B6 (Row 5 will be used to report findings from the right eye, and Row 6 will be used to report findings from the left eye). The eye of interest (i.e., right or left) is specified in Column F. Part 1: Reporting clinical findings The ‘Clinical findings’ section of this worksheet (Figure 7, Columns G to R) is designed for you to directly enter your retinal fundus examination findings (as defined in Table 5) from the patient record into the spreadsheet. Note: this section is not to detail whether the clinical test was performed, rather you should provide details about what your clinical findings were. If no specific retinal findings were noted on the patient record itself, however retinal fundus photographs are available, the retinal features from the photograph should be entered.

Figure 7. Layout of CCAT ‘Clinical findings and diagnosis’ worksheet – ‘Clinical findings’


19

Table 5. Summary of the key clinical signs for DR (based upon the NHMRC Guidelines for the Management of Diabetic Retinopathy, 2008)

Clinical sign Description Patient record details (What findings were noted on the patient

record?

Response options*

Microaneursym (MA) • Small red dots in the superficial retinal layers due to capillary wall outpouching secondary to pericyte loss

• Present? • If Yes, # (how

many?)

Yes/No Enter number1

Dot or blot haemorrhages (haems)

• Intra-‐retinal haemorrhages within the nuclear (dot) or plexiform (blot) retinal layers

• Present? • If Yes, # (how

many?)

Yes/No Enter number1

Cotton wool spots (CWS) • Retinal nerve fibre layer infarctions • Present? Yes/No Hard exudates (HEx) • Lipid exudation, within the posterior

pole, caused by a breakdown of the blood retinal barrier

• Present?

Yes/No

Intra-‐retinal microvascular anomalies (IRMA)

• Remodelled capillary beds, without proliferative change; typically found at the borders of non-‐perfused retina

• Present?

Yes/No

Venous beading • Periodic variations in the diameter of retinal venules along their length (“beaded appearance”)

• Present? Yes/No

Neovascularisation (neovasc)

• Growth of abnormal new vessels and fibrous tissue in response to retinal ischaemia

• NVD, new vessels on disc: vessels on or within 1DD of the optic disc margina

• NVE, new vessels elsewhere: vessels in other locationsa

• Neovascularisation of one, or more, of the iris, optic disc or retina

Yes/No

Vitreous or pre-‐retinal haemorrahgea

• Vitreous haemorrhage: diffuse haze or coagulated blood within the vitreous gel

• Pre-‐retinal haemorrhage: blood within the space between the retina and the posterior hyaloid face

• Present? Yes/No

Retinal thickening within a radius of 1DD of the fovea

• Capillary leakage resulting in retinal thickening within a 1DD radius of the fovea, termed diabetic macular oedema (DME)

• Present? Yes/No

Retinal thickening within 500µm of the foveal centre, OR HEx within 500µm of the fovea with adjacent retinal thickening

• Capillary leakage nearer to the foveal centre, termed clinically significant macular oedema (CSME)

• Present? Yes/No

1 If the exact number is unclear from the patient’s record, provide as much information as possible (e.g., >10, < 20, 50, few, ? = unknown). a High-‐risk characteristics of proliferative diabetic retinopathy (PDR), signifying a poor visual prognosis are: NVD ≥ 1/3 disc area in extent, OR any NVD with vitreous or pre-‐retinal haemorrhage, OR NVE ≥ 1/2 disc area in extent associated with vitreous or pre-‐retinal haemorrhage, OR vitreous or pre-‐retinal haemorrhage obscuring ≥ 1 disc area


20

Part 2: Assessing accuracy of diagnosis for DR The ‘DR severity grading’ and ‘DME grading’ sections of this worksheet (Figure 8, Columns S to AA) are designed to allow you to assess the accuracy of your retinal grading for:

i) diabetic retinopathy severity, and ii) absence or presence of diabetic macular oedema

based upon the clinical findings information you have already entered (Columns G to R) in this worksheet.

Figure 8. Layout of CCAT ‘Clinical findings and diagnosis’ worksheet – ‘DR & DME grading’

You should use the drop-‐down menu in the appropriate cell to respond to the questions, as defined in Table 6.

Table 6. Summary of the questions relating to the grading of DR and DME Question Response options

Was the severity of DR graded on the patient’s record? Yes/No If Yes, what did you grade it as on your clinical record? OR If No, what do you think it should have been graded as?

No apparent DR/Minimal NPDR/ Mild NPDR/Moderate NPDR/ Severe NPDR/PDR

Which DR grading system did you use? Simplified ETDRS (Wisconsin)/ International Clinical DR scale/ Other

Based upon the NHMRC guidelines, what grade of DR should this be?a

No apparent DR/Minimal NPDR/ Mild NPDR/Moderate NPDR/ Severe NPDR/PDR

Was your original grading correct? (compare text in column T to V), if these are the same then select ‘Yes’ otherwise select ‘No’).

Yes/No

Was DME noted on the patient’s record? Yes/No Based upon the retinal findings you reported, was your assessment of DME correct? (compare Yes/No text in column Q to X), if these are the same, then select ‘Yes’, otherwise select ‘No’).

Yes/No

Was CSME noted on the patient’s record? Yes/No Based upon the retinal findings you reported, was your assessment of CSME correct? (compare Yes/No text in column R to Z), if these are the same, then select ‘Yes’, otherwise select ‘No’).

Yes/No

a To assess the accuracy of your original grading, you should refer to the NHMRC Guidelines for the Management of Diabetic Retinopathy (2008); see Appendix 1. Table 2.1.1 of the NHMRC guidelines summarises the classification of diabetic retinopathy into retinopathy stages (using the simplified Early Treatment Diabetic Retinopathy Study staging system -‐ Wisconsin level) and the predictive values of retinal lesions. Table 2.1.2 of the NHMRC guideline summarises the International Clinical Diabetic Retinopathy and Diabetic Macular Edema Disease Severity scales, and recommended referral patterns.


21

7. ‘Management’ worksheet: Overview: The ‘Management’ worksheet (Figure 9) enables an assessment of the adherence of the management approach to the NHMRC Guidelines for the Management of Diabetic Retinopathy, for each patient, based upon the grading of DR severity noted by the practitioner.

Figure 9. Layout of CCAT ‘Management’ worksheet – Columns G to L

Instructions for use: The ‘patient reference’ (column A) will have automatically populated into this worksheet from the ‘Visits’ worksheet; you do not need to enter this information. e.g., 43007 appears in A5 through to A12. The date for each comprehensive visit (columns B to E), will also have automatically populated from the data you entered in the ‘Visits’ worksheet; if you entered fewer then four visits, the cells corresponding to the visits that are not applicable to that patient will appear black. e.g., 01.04.2014 automatically appears in B5 and B6. The eye of interest (i.e., right or left) is specified in Column F. In this worksheet, columns that have a yellow highlight (columns G, H and L) will automatically populate responses based upon the previous data you have entered; you do not need to manually enter any values into these columns. You should use the drop-‐down menu in the appropriate cells to respond to the questions, as defined in Table 7.


22

Table 7. Summary of the questions relating to the management of DR and DME Question Response options

What was the severity of DR noted on the patient’s record card?

No apparent DR/Minimal NPDR/ Mild NPDR/Moderate NPDR/ Severe NPDR/PDR (self-‐populates)

Was DME considered to be present? Yes/No (self-‐populates) Is this a patient at ‘high risk’a of DR? Yes/No How did you manage this patient? (note: this is the management of the patient ‘overall’, and should have been dictated by the eye having more severe DR or DME, if present)

Ophthalmology referral – urgentb/ Ophthalmology referral – routinec/ Review 3 months/ Review 6 months/ Review 12 months/ Review 2 years/ Review -‐ other

Did you write a letter to the patient’s GP? Yes/No Management recommendation, according to NHMRC guidelines, based upon grade of DR and presence or absence of DME, per eye

Urgent ophthalmology referral – within 4 weeks/ Ophthalmology referral/ Review 3-‐6 months, or routine ophthalmology referrald/ Review 6-‐12 months, taking into account proximity of MAs to the macula/ Review 2-‐yearly if not at high risk, or annually if one or more risk factors are present/ (self-‐populates)

Was your overall management consistent with the NHMRC guidelines (you should compare column J to L). Note: overall management should be judged on the eye with the most severe DR/DME.

Yes/No

If No, how was management advice inappropriate?

Review period was too short/ Review period was too long/ Ophthalmology referral when not indicated/ Did not refer for ophthalmologic opinion when indicated

Did the patient follow your recommended management?

Yes/No/Not knowne

If No, detail what happened

Open-‐ended text field (e.g., patient moved interstate and lost to follow-‐up)

a Based upon the NHMRC Guidelines for the Management of Diabetic Retinopathy (2008), a patient who is at ‘high risk’ for diabetic retinopathy has one, or more of the following risk factors: -‐ longer duration of diabetes -‐ poor glycaemic control -‐ inadequately controlled systemic hypertension -‐ inadequately controlled hyperlipidaemia -‐ Indigenous or Torres Strait Islander -‐ non-‐English speaking background b Urgent ophthalmology referral should be within four weeks of presentation c Routine ophthalmology referral should be undertaken in consultation with the ophthalmologist to determine their preferred referral timeline to achieve an optimal visual outcome d The previous NHMRC guidelines for the Management of Diabetic Retinopathy (1997) suggested that patients should be referred for ophthalmologic opinion if DR greater than the presence of occasional MAs was observed. The 2008 guidelines suggest that while there doesn’t appear to be recent data to suggest that this timing needs changing, because there is no clear evidence to support routine referral at a particular level of NPDR, the referral recommendation should no longer be used as a guideline, but is a relevant recommendation. e ‘Not known’ can be used to indicate if the recommended patient review period is beyond the audit period.


23

8. ‘Summary statistics’ worksheet: Overview: The ‘Summary statistics’ worksheet (Figure 10) is a fully self-‐populating worksheet and chart that provides a summary of the key features of your clinical audit, sub-‐categorised as follows:

(i) audit particulars a. number of patients b. number of comprehensive visits c. average number of comprehensive visits per patient over the audit period

(ii) general patient information

a. % patients whose DOB was noted b. % patients whose gender was noted c. % patients whose ethnicity was noted d. % patients whose GP details were noted

(iii) diabetic retinopathy risk factors

a. % patients whose type of diabetes was noted b. % patients whose duration of diabetes was noted c. % patients whose HbA1c was noted d. % patients whose blood pressure status was noted e. % patients whose systemic lipid status was noted f. % patients whose family history of diabetes (+/-‐) was noted

(iv) essential exam procedures for DR assessment

a. % of visits where monocular VA was noted b. % of visits were slit lamp findings were noted c. % of visits where any form of posterior eye exam was performed d. % of visits where a DFE was performed e. % of visits where indirect ophthalmoscopy was performed

(v) other recommended exam procedures

a. % of visits where a retinal fundus photo was taken b. % of visits where a macular OCT was performed

(vi) diagnosis (Dx) of DR

a. % of (eye) visits where severity of DR was noted on record card b. % of (eye) visits where severity of DR grading is considered accurate c. % of (eye) visits where DME considered to be accurately identified d. % of (eye) visits where CSME considered to be accurately identified (Note: an (eye) visit is based upon examining the diagnostic findings per eye, per visit)

(vii) management (Mx) of DR

a. % of patient visits where a letter was written to the GP b. % of patient visits where Mx was consistent with NHMRC guideline c. % of patient visits where patients followed management advice

The purpose of the summary statistics worksheet is to provide you with an overview of your clinical strengths, and any weaknesses, in terms of the ophthalmic care provided to your patients with diabetes. This information should guide you in potentially modifying any practices to improve the clinical care that you provide to your patients. As shown in Figure 10, the data are displayed in both a text format (left hand side) and graphical format (right hand side).


24

Figure 10. Layout of CCAT ‘Summary statistics’ worksheet


25

Appendix 1 – Diabetic retinopathy grading scales from the NHMRC Guidelines for the Management of Diabetic Retinopathy (2008)


26

Guidelines for the Management of Diabetic Retinopathy 61

Table 2.1.2: International Clinical Diabetic Retinopathy and Diabetic Macular Edema Disease Severity scales, and recommended referral patterns359

Rate (%) of Progression to PDR

Early High Risk

Retinopathy stage Findings on ophthalmoscopy ETDRS Level

1 yr 3 yrs 1 yr 3 yrs

Management

No apparent retinopathy

No abnormalities 10

Minimal NPDR Microaneurysms only 20 Mild to moderate NPDR

More than just microaneurysms but less than severe NPDR 35, 43, 47 5-26 14-48 1-8 7-24 Ophthalmology referral

Severe NPDR

Any of the following: More than 20 intraretinal haemorrhages in each of 4 quadrants Definite venous beading in 2+ quadrants

Prominent intraretinal microvascular abnormalities in 1+ quadrant AND no signs of proliferative retinopathy

53 A-E

52

71

17

44

Ophthalmology referral

Proliferative DR One of the following: Neovascularisation Vitreous / preretinal haemorrhage

61, 65, 71, 75, 81, 85

46 67 Ophthalmology referral; laser treatment

Macula oedema Absent No retinal thickening or hard exudates in posterior pole Present Mild – some retinal thickening or hard exudates in posterior pole but

distant from the macula Moderate – retinal thickening or hard exudates approaching the centre of the macula but not involving the centre Severe – retinal thickening or hard exudates involving the centre of the macula

Ophthalmology referral; consider laser Consider laser Laser treatment

aclinical care!audit!tool!(ccat)!for! australianoptometrists:!! · 2015-05-13 ·...

Documents