Quality Improvement Toolkits

Public Health Wales / Hypothyroidism monitoring
Hypothyroidism Monitoring
Quality improvement toolkit
Author:Primary Care Quality and Information Service
Date: November 2010 / Version:1
Status:Final
Intended audience: Public (Internet) / NHS Wales (Intranet) / NPHS (Intranet)
The former Public Health Wales Primary Care Quality Team, now incorporated within the Primary and Community Care Development and Innovation Hub, developed a series of quality improvement toolkits to assist practices in collating and reviewing information. From information received, practices still find these toolkits useful, therefore they will remain on this webpage for your ease of reference. Please note, however, that the date of publication is clearly stated in the toolkit and that the evidence within may have changed since publication.
Publication / distribution:

Publication in NPHS Document Database (Primary Care Quality and Information)
Link from NPHS e-Bulletin

Preface

Quality Improvement toolkits

The Primary Care Quality and Information Service(PCQIS)have developed quality improvement toolkits to assist practices in collating and auditing information

The quality improvement toolkits are evidence-based. They should be seen as good practice and cover areas that some or even all practices may not be recording at this stage. It is not expected that all the criteria within the audits will be achieved in year one therefore the PCQIS suggests that the toolkits should be used to aid development within the practice

It is recommended that in year one the practice consider recording this information prospectively using the data entry criteria and suggested READ Codes provided so that these criteria can be successfully audited and improvements highlighted over time.

These toolkitsare designed to assist practices with data quality/quality improvement – practices and Local Medical Committees will need to negotiate with LHBs whether and how these toolkits can be used for contract monitoring. It is important that any monitoring arrangements are agreed at the start of the contract year.

The PCQIS recognises that some of the criteria in the audit proforma section may involve data that is not currently kept routinely by all practices. Therefore it is recommended that in year one the practice consider recording this information prospectively (using the data entry criteria and suggested read codes provided) so that these criteria can be successfully audited and improvements highlighted over time.

You can access other quality improvement toolkits that support Enhanced Services and National Service Frameworks from the Public Health Wales (PHW) website:

Intranet

Internet

Approved read codes (in version 2 and clinical terms version 3) have been developed to support practices wishing to build searches and extract the data from their clinical system. These READ Codes will also be available within the data quality audit and reporting tool released by the Primary Care IM&T Programme. If practices wish to access the Read Codes please use the above links to the PHW website.

Contents

Page

Preface3

1.Introduction and background5

2.Aims5

3.Methodology5

4.Patient audit – general guidance6

5.Patient Audit – Criteria7

6.Data Collection Summary9

7.Practice review10

References11

Appendices (Hyperlink)

Material contained in this document may be reproduced without prior permission

provided it is done so accurately and is not used in a misleading context.

Acknowledgement to the Primary Care Quality and Information Service, to be stated.

Author
Primary Care Quality and Information Service / Date
Nov 2010 / Status; Final
Version; 1 / 1 / Intended Audience: Public (Internet) / NHS (Intranet) PHW (Intranet) / PCQIS
Public Health Wales / Hypothyroidism monitoring

1.Introduction and background

The purpose of the Primary Care Quality and Information Service is to assist primary care practitioners improve the quality of the service they deliver by providing access to evidence based quality improvement guidance and tools. This toolkit will assist practices to improve the data quality required to support the review of services to patients with hypothyroidism.

Hypothyroidism is a common chronic disorder. AnnualUK incidenceof primary hypothyroidism is 3.5 / 1000 in women and 0.6 / 1000 in men.1,7Ongoingmanagementof hypothyroidism is routinelyprovidedin primary care, yet care quality is variable. Surveys of patients taking levothyroxine showthat 40% to 48% receive sub-optimal doses of medication2,3A small but significant number taking levothyroxine in therapeutic doses report symptoms or side effects 4.

Hypothyroidism has a number of recognised signs / symptoms. Patients with a severe form of the condition can display a number of these signs. Conversely patients with a milder form, especially older people may exhibit few or no signs. In additionthese signs and symptoms can also suggest other conditions and can be present in many who are clinically euthyroid.

Hypothyroidism isconfirmed by abnormal thyroid function test(TFT) results. A thyroid stimulating hormone (TSH) greater than 10mU/L combined with free thyroxine (FT4)below the reference range (see appendix B, page 15) indicates overt primary hypothyroidism inambulant subjects.TSH levels above this range, withFT4within range, defines subclinical (mild) hypothyroidism,andrequires confirmation 3-6 months after the first results, to exclude transient elevated TSH. Subclinical patients who have tested positive for thyroid peroxidase antibodies (TPOAb) or thyroglobulin antibodies (TgAb) are more prone to raised serum TSH,increasing the risk of developing overt hypothyroidism. If the serum TSH is within the reference range and the patient is not taking anymedication known to affect TSH then primary hypothyroidism isexcluded. Secondary hypothyroidism is a possibility if clinically suggestive5

2.Aims

To support practices to identify all patients on the practice list with hypothyroidism and ensure ahigh quality standard of ongoing care.

3Methodology

3.1Use retrospective data over a 12 month period

3.2Set a start and end date for the data collection

3.3Compile a list of patients from the practice computer system of all patients with a diagnosis of primary or sub-clinical hypothyroidism (CO4.. / CO47.)

3.4A search for patients taking levothyroxine,and who have abnormal thyroid function test resultswill identify patients with hypothyroidism but who have yet to be coded (see also additional guidance regarding patient selection in section 5 on page 7/8).

3.5Collect relevant data and record using the data collection sheet provided(See Appendix D)

3.6Collate and analyse results of the data collection process

3.7Reflect on the results of the audit and decide any changes to practice that you consider appropriate (Using the practice review form enclosed in section 7 on page 10)

3.8Decide on a date to re-audit to confirm changes (if recommended)

Author
Primary Care Quality and Information Service / Date
Aug2010 / Status; Final
Version; 1 / Page 1 / Intended Audience: Public (Internet) / NHS (Intranet) PHW (Intranet) / PCQIS
Public Health Wales / Hypothyroidism monitoring

4 Patient audit – general guidance

Compile a list of all patients, over the age of 16 with a diagnosis of hypothyroidism or by running a drug search of patients taking thyroid medications (levothyroxine - all brands and strengths) currently, and who have a history of abnormal thyroid function test results (exclude those patients coded as hyperthyroid – CO0..% / CO1..% / CO2..% and who may also be taking levothyroxine). By searching on medication, and then review of TFT results the practice willbe able to identify patientswho haveovert primary hypothyroidism but who may not have yet been coded as such.

Caution should be taken using this method however as some patients with a hyperthyroid, and / or another condition may also be taking levothyroxine. It is recommended that close attention be made to the TFT test results before deciding upon and recording a diagnosis of hypothyroidism. It should be noted also that some patients with mild hypothyroidism may have TFT readings that are within or marginally outside of normal ranges, but who are treated with replacement therapy based on symptoms.

Patients who are found to have primary hypothyroidism but who have not been coded should be coded appropriately (CO4..%). These patients can then be included in the ongoing management arrangements and the information recorded used to review the ongoing quality of care through future audit.

The data collection sheet (Appendix D) and summary sheet (page 9) provide for the practice to record those patients who have been included within the audit population.

Where information is not available the practice is asked touse the comments section to describe the omissions, and actions it will consider to improve data recording.

The practice may find that a patient has recently registered, or has been newly diagnosed (within the last 12 months), DNA scheduled appointment/s, or attends hospital out-patients departments (OPD) only and thus unavailable for ongoing management. Insuch circumstancesthe practice shouldensure thatthe diagnosis of hypothyroidism is recorded, all received subsequent relevant information is recorded, and the patientincluded for future review. The patient should then be excluded from the current audit but included in subsequent audits.

Collate and aggregate the results using the summary sheets. A separate data entry sheet is to be found at Appendix D for practices preferring to use a manual data collection process.

Reporting and Audit+

The Primary Care IM&T Programme

have procured the software product Audit+ which is available without charge to all practices in Wales. Audit+ is designed to assist practices improve data quality. Audit+ provides identical audit capabilities for practices regardless of their clinical information system. Audit+ affords all practices in Wales a common platform which can be developed to provide additional tailored modules to support Practices to respond to the emerging clinical agenda. The reporting module within Audit+ supports review of those data items that are included in the quality and outcome framework for hypothyroidism.Audit+ will also assist practices in correctly identifying patients with a definite diagnosis. The tidy up facility within Audit+ mayassist practices to identify patients taking thyroid replacement medication,or being managed for hypothyroidism but who do not have a recorded diagnosis of hypothyroidism

Review

It is recommended to use the results of the audit as the basis of a discussion by the primary health care team (PHCT) and any changes to procedure can be agreed

Re-audit

Repeat the process at least annually to ensure that any changes that the practice consideredtobenecessary and implemented are having a positive effect on patient care.

5 Patient Audit – Criteria

Patients to be included within the audit

All adult (>16 years) patients registered in the practice and with a diagnosis of primary or sub-clinical hypothyroidism >12months.

Patients to be excluded from the audit

Exclude all patientswho have been diagnosed with hypothyroidism within the preceding 12 months. Exclude all patients ≤16 years of age.

Diagnosis

5.1All patients with a diagnosis of primary hypothyroidism (C04..%) havea TSH level>10mU/L and FT4 level below the reference range recorded in their medical record atdiagnosis

5.2All patients with a diagnosis of subclinical hypothyroidism (C047.) have their TSH and FT4 re-testedwithin 6months of first test and TSH was between 5 and 10mU/L

5.3All patients with a diagnosis of subclinical hypothyroidism have been tested for thyroid antibodies (TPOAb) toestablish the degree of risk of developing overt hypothyroidism

Rationale

Hypothyroidism cannot be diagnosed accurately on symptoms alone. Accurate diagnosis relies on TFT results. A TSH greater than 10mU/L combined with a FT4below the reference rangeindicates the presence of overt primary hypothyroidism in ambulant subjects

Some adultshave less severe hypothyroidism, with a serum thyroidstimulating hormone that is increased (typicallybetween 5 mU/L and 10 mU/L) but a serum thyroxineconcentration within the reference range. This istermed subclinical hypothyroidism (also called mildhypothyroidism) and in many patients it represents astate of compensated or mild thyroid failure6.

Depending on the age andgender of the population studied subclinical hypothyroidism is present in between 1.3% and 17.5%of the UK or US populations. Subclinical hypothyroidism should beconfirmed by repeat thyroid function testing 3-6 months after the original result5.

Treatment

5.4All patients with a diagnosis ofovert primary hypothyroidismaretreated withthyroxine (unless contra-indicated)

Rationale

Thyroid function tests are the mainstay of monitoring thyroxine replacementtherapy. The recommended approach in primary hypothyroidism is to titrate thyroxinedose against the TSHconcentration whilst assessing clinical well-being.The targetis a serum TSH within the reference range. In the majority of patients 50-100μg of thyroxine canbe used as the start dose (a higher start dose maybe indicated post-Thyroidectomy).

Dose titration isachieved by using 25-50μg increments and repeat TSH tests 2-3 monthsafter a dose. Following this most patientswill become clinicallyeuthyroid with a ‘normal’ TSH and having thyroxine replacement in the range 75-150μg/day (1.6ug/Kg onaverage).

This strategy prevents over-replacement and reduces adverse cardiovascular effects.In elderly patients and those with ischaemic heart diseaseconsideration should be given to commence replacement with 25μg thyroxine andtitrate up in 25μg increments in an attempt toavoid cardiac complications. There is evidence of improvement in the lipid profile and symptoms when patients withsubclinical hypothyroidism and modestly raised TSH (mean 11.7mU/L) were rendered euthyroid with thyroxine 5although a recent scientific reviewby an expert panel did not support the routine use ofthyroxine in subclinical hypothyroidism6.

Monitoring(in patients who have been in receipt of Thyroxine for 12 months or longer);

5.5Patients stabilised on long-term replacement therapy have serum TSHchecks annually

5.6Patients on long term replacement therapy have had their TSH tested 2-3 months following a change of dose

5.7Patients stabilised on long-term replacement therapy have a TSH level within the reference range (see appendix B)

Rationale

Once stabilised on thyroxine all patients should have their serum TSH checkedannually as a change in requirement for thyroid hormone can occur with ageing. In some parts of the UK computerised thyroid registers have been establishedand shown to be successful in ensuring excellent automated follow up for thyroidpatients on replacement therapy5.

Measurement of TSH combined with FT4 is recommended when optimizingthyroxinereplacement therapy. This is because of the misleading results that can beproduced by patients who have intermittent or poor compliance with their treatment. Once the patient is clinically stabilized on thyroxine serum TSH alone may beused to monitor therapy5.

The minimum period to achieve stable concentrations after a change in doseof thyroxine is two months and thyroid function tests should not normally berequested before this period has elapsed5

The optimal dose of thyroxine for long-term therapy is assessed from theresults of thyroid function tests together with clinical findings. Indetermining the optimal dose of thyroxine the biochemical target is a TSHresult that is detectable, and in the majority of cases within the referencerange5.

6Data Collection Summary

Standards

Practices may wish to allocate their own standards. Please note that these standards are primarily ones of the recordings of information, and the results collated to measure against them would be expected to improve over time as the quality of recording of the required information improves.

Audit Start Date ______Completion Date______

Number of patients coded as Primary Hypothyroid (CO4..%)______Number of patients coded as Sub-clinical Hypothyroid (CO47.%) ______

Number of patients identified as having Primary Hypothyroidism but not READ coded______(These patients should now be coded CO4..)

Criteria / Number of patients / % of sample / Standard / READ Codes
A / Patients with primary hypothyroidism (C04..%) have a TSH level >10mU/L and FT4 level below the reference range recorded at diagnosis / C03.. C04.. C047. C040. C043z C044. C046. 442.. 4421. 4422. 4423. 442A0 442A1 C1343 4426. 44260 44261 4427. 4428. 442V. 442c. 43G5. 43mQ. 66B9. 66BA. TJ271
B / Patients diagnosed with sub-clinical hypothyroidism (CO47.%) with a TSH between 5 and 10mU/L have had TSH and FT4 re-tested within 6 months
C / Patients in B have been tested for thyroid antibodies (TPOAb)
D / Patients in A are treated with thyroxine (unless contra-indicated)
E / Patients in D contra-indicated to thyroxine
F / Patients in D who have been in receipt of thyroxine >12months
G / Patients in Fwho have had TSH Re-Tested within 12 months
H / Patients whose dosage of thyroxine has altered since diagnosis
I / Patients in H who had TSH Re-Tested within 3 months of each dose change
J / Patients inG and Iwho have a TSH level within the reference range
Author
Primary Care Quality and Information Service / Date
Aug2010 / Status; Final
Version; 1 / Page 1 / Intended Audience: Public (Internet) / NHS (Intranet) PHW (Intranet) / PCQIS
Public Health Wales / Hypothyroidism monitoring

7.Practice review

A. What lessons did the practice discover from carrying out this audit?

B. What changes, if any have the practice agreed to implement as a result of this audit?

What support would enable the practice to enhance the service it provides to patients

This audit was compiled by;

Name(s) ______

Signature(s) ______

Practice (Name and Address)

Date ______

References

Vanderpump MP, Tunbridge WM, French JM, Appleton D, Bates D, Clark F, et al. The incidence of thyroid disorders in the community: a twenty-year follow-up of the Whickham survey. Clinical Endocrinology (Oxford) 1995; 43:55-68.[Medline][LinkSolver]

2Canaris GJ, Manowitz NR, Mayor G, Ridgway EC. The Colorado thyroid diseaseprevalence study. Arch Intern Med 2000; 160:526-34.[Abstract/FreeFullText]

3Parle JV, Franklyn JA, Cross KW, Jones SR, Sheppard MC.Thyroxine prescription in the community: serum thyroid stimulating hormone level assays as an indicator of under-treatment or overtreatment. British Journal of General Practice; 1993;43:107-9.

[WebofScience][Medline][LinkSolver]

4Saravanan P, Chau WF, Roberts N, Vedhara K, Greenwood R, Dayan CM. Psychological well-being in patients on ‘adequate’ doses of l-thyroxine: results of a large, controlled community-based questionnaire study. Clinical Endocrinology (Oxford) 2002; 57:577-85.[CrossRef][Medline][LinkSolver]

5 UK Guidelines for the use of Thyroid Function Tests (2006); British Thyroid Association

6 Vaidya B, Pearce S; Management of hypothyroidism in adults. BMJ (2008)

7The NHS Information Centre; Clinical and Health Outcomes Knowledge Base, Prevalence of Hypothyroidism; Accessed Nov 2010.

Author
Primary Care Quality and Information Service / Date
Aug2010 / Status; Final
Version; 1 / Page 1 / Intended Audience: Public (Internet) / NHS (Intranet) PHW (Intranet) / PCQIS