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• Antenatal Screening for Down syndrome and other conditions - implementation issues

  

  The new first trimester combined and second trimester maternal serum screening options for antenatal screening for Down syndrome and other conditions are more accurate than those previously available in New Zealand. International evidence shows that as many as one in five women who are screened using nuchal translucency (NT) alone, with a detection rate of 60 to 70 percent, are offered diagnostic testing. By comparison, first trimester combined screening, which includes maternal serums along with NT, as well as information such as maternal age and weight and gestational age, results in a detection rate of 83 percent. A number of implementation issues have been identified since the introduction of the new screening options.

  These include:

  • Lead maternity carers (LMCs) requesting an NT scan, and then only completing a request for first trimester serums if the NT is increased. This causes significant confusion for women and delays in ordering appropriate screening tests, and may mean the woman is unable to complete first trimester combined screening. This practice also leads to increased anxiety for those women (approximately 14 percent) who have an increased risk based on the scan and then low risk when the results are combined. Internationally this is not accepted practice, and women are seldom comforted by the low risk result when they have previously received an increased risk. Many of these women will still request diagnostic testing regardless. This practice negates the advantages of first trimester combined screening and is not recommended. 
  • Women who are not informed that first trimester combined screening is a two-step process (bloods and NT) and that they need to have each test within certain timeframes. It is recommended that first trimester maternal serums be taken at 10 to 12 weeks and the NT between 11.5 and 13.5 weeks. For the process to work in a timely way, it is often practical to recommend a woman has her blood test taken first and her NT done second.
  • Women continuing to expect the radiologist to provide them with a risk assessment after their NT scan and prior to the combined result from the laboratory. When women are being offered first trimester combined screening, they need to be made aware that the screening result will be given to them by their LMC/referrer after the blood and NT results have been analysed by the laboratory and combined into a single risk result. 
  • Continued use of the old referral forms. This has caused confusion as the request is likely to be for the wrong test within the wrong time period. It is recommended that maternity providers dispose of supplies of their old forms and use only the newly distributed Combined/Maternal Serum Screening Lab Form. If you do not have these forms please contact LabPLUS at 0800 522 7587 or Canterbury Health Laboratories at 0800 THE LAB (843 522), extn 80484 to order them.
  • Clinical information missing from the laboratory request form when it is received by the laboratory. Maternal weight, for example, is critical for the risk calculation. The best way to ensure that all the necessary information is provided is to complete all sections on the Combined/Maternal Serum Screening Lab Form. The screening result cannot be completed until all the required clinical information is provided.  
  • Referrer details missing from the laboratory request form, eg, forms arriving with ‘J Brown’ or ‘Dr Smith’ on them as the requesting practitioner and no other details. The results cannot be provided until the referrers’ contact details are known.

  If you do not have a copy of the ‘Guidelines for maternity providers offering antenatal screening for Down syndrome and other conditions in New Zealand’, these can be ordered from the National Screening Unit (NSU) by contacting Cheryl Palmer, EA, Antenatal and Newborn Team: cheryl_palmer@moh.govt.nz or 09 580 9080.

  Please go to: www.learnonline.health.nz You can complete the education modules and gain Royal NZ College of General Practitioners-endorsed or Midwifery Council of New Zealand approved, professional development/ongoing education points or use the site as a resource.  If you have any questions about the new options for screening for Down syndrome and other conditions, please view our website or contact us via: screening@moh.govt.nz

• Guidelines for Cervical Screening in New Zealand - Guidance on HPV Testing, Update 1, March 2010

  

  This is the first in an ongoing series of updates of the 'Guidelines for Cervical Screening in New Zealand', released by the National Cervical Screening Programme (NCSP) in August 2008.

  Note that guidelines are intended only as an aid to clinical practice, not as a substitute for clinical judgment. Clinicians should continue to manage patients on the basis of personal and family medical history, and clinical signs and symptoms, as well as formal guidelines.

  Testing for high risk (oncogenic) HPV types (HrHPV) was introduced in New Zealand in October 2009. This reflects accumulating evidence on the clinical utility and cost effectiveness of HrHPV testing alongside cervical cytology in the management of women with cervical abnormalities.

  The addition of HrHPV testing to cytology and colposcopy offers several advantages, including both greater sensitivity for the detection of CIN2/3 or cancer and a higher predictive value of a negative test. That is, testing negative for HrHPV implies a very low risk of CIN2/3 or cancer. HrHPV testing thus helps clarify the risk of having significant cervical disease against the harm of having unnecessary interventions.

  HrHPV testing is currently recommended in the Guidelines in three clinical situations:

  Situation	Initiator of this test
  1.Women 30 years and older with ASC-US or low grade changes, to help assess risk of progression.	Laboratories (the HrHPV result is reported at the same time as the ASCUS /LSIL result) Smear takers are required to ensure that all women over 30 years are informed about HPV testing.
  2.Women (all ages) treated for a high-grade lesion, to help assess whether the lesion has been completely resolved. Includes ‘historical testing’ for women on annual smears for previous high-grade lesions and with negative smears since, to assess whether they can return to routine three yearly screening - refer to second flowchart.	The smear taker, after discussing with the woman.
  3.Where colposcopy has shown discordant results from cytology, to help interpret these results.	Colposcopists.

  Who should not be offered HrHPV testing as part of the NCSP?

  Women under 30 years (unless they have had a previous high-grade (HSIL/ASC-H) lesion). Note that where HrHPV testing is requested outside the Guidelines, women may be asked to pay for it.

  The following interim advice relates to situation 2 above.

  NCSP Interim Advice: HrHPV testing for women with previous high-grade lesions.

  1. HrHPV testing of women treated for high-grade lesions (HSIL/ASC-H) within the last three years
  The 2008 guidelines for HrHPV testing following colposcopy refer to women who have been recently treated at colposcopy. In this context, ‘recent’ can be interpreted as meaning within the past three years (three years has been recommended in order to distinguish failure of colposcopic treatment from a new infection). Women in this situation who test HrHPV positive, despite having cytology assessed as negative on one or two occasions post colposcopy, should be referred back to colposcopy. The reason for this is the risk of residual disease requiring assessment and further treatment, despite the apparently negative cytology.

  Follow up of women treated for high grade lesions in the last three years. As indicated in Flowchart HPV Testing Guidance 2 (pgs 51 and 52 of Guidelines for Cervical Screening in New Zealand), summarised below. 

  2. HrHPV testing of women with a high-grade lesion (HSIL/ASC-H) followed by colposcopy (or no treatment) more than three years previously, with subsequent repeated negative cytology tests (historical testing).
  Women with previous high-grade lesions (HSIL/ASC-H), treated or not treated colposcopically, and currently managed by annual cytology for more than three years, with all tests assessed as negative, may benefit from dual cytology and HrHPV testing. This is because the high negative predictive value of HrHPV testing together with a double negative (cytology and HrHPV) implies a low risk of CIN2/3+. If these women test negative by both tests over two years, they can be screened with cytology alone every three years until 70 years of age.

  However, some women will test positive for HrHPV despite the repeated negative cytology tests. These women are also likely to be at very low risk of CIN2/3 or worse and can be retested with cytology and HrHPV testing annually. A positive HrHPV test where cytology remains negative is not a cause for immediate concern in these circumstances, however contributes to the overall assessment of a woman’s risk status.  

  Please note:

  • This NCSP update should assist clinicians to determine future management, based on a woman’s risk of CIN2/3+. The NCSP plans to review data held on the NCSP-Register and to further refine this advice within six months.
  • As with all tests, it is important to explain to women the reason for the test, gain their consent, and explain the implications of results.
  • The practice of offering HrHPV testing to women already undergoing annual cytological review for a previously treated HSIL follows that published in the Australian NHMRC guideline (9 June 2005).
  • A further update will be provided on the use of HrHPV testing in the management of glandular abnormalities and post hysterectomy.

  The full interim statement which includes references is available on the website - go to Guidance on HPV Testing, Update 1, March 2010

• Nelda Taurua - Moe mai ra e te tuahine (Rest in peace)

  

  Tēnei ra e kōkiri i ngā kōrero, i ngā māhara, i ngā tangi
  ki tērā o a tātou Whāea kua roa nei e whawhai ana i te ngangara mate pukupuku,
  hei oranga māna, hei oranga mā te iwi whānui tonu
   
  E Nelda, me pēhea e taea te whakakī i o hū?
  Mā wai hoki ō mahi e kawe?
   
  Nāu anō i tū ki te whakawahawaha i ngā ratonga hei whainga mā te tini, nāu hoki i whakapāōho atu i ngā pānga o te mate nei.
   
  E te Whāea, kua riro i a koe tō moenga roa, tē ara ake anō.
  Takoto mai i te kōpu ō Papatuānuku
  Kua tāia ai koe ki te moko o aitua
  Hoea tō waka kia ū mārire atu ki te whenua taurikura ki Hawaiki,
  ki te huinga o te kahurangi.
   
  E hika, Tāoki mai ra, tāoki mai ra, tāoki mai ra!

  We gather our memories and mourn the passing of someone who has long battled cancer. An inspiration for all she was.
   
  Nelda stood as a support person for many and was a strong advocate for cancer screening services and cancer awareness.
   
  May your body rest within Papatuanuku
  And your spirit sail towards the homeland,
  Towards the gathering of the spirits
   
  Rest in peace, rest in peace, rest in peace!
  
  The National Screening Unit would like to acknowledge and farewell Nelda Taurua, Health Promotion/Recruitment coordinator for BreastScreen Waitemata/Northland who passed away recently.

• Screening for Congenital Hypothyroidism

  

  The ‘Guidelines for practitioners providing services within the Newborn Metabolic Screening Programme’ include information on the disorders screened by the programme. In this issue of Screening Matters we begin a series of articles about the disorders screened for. Congenital hypothyroidism is the first topic. 

  Congenital hypothyroidism screening
  Congenital hypothyroidism (CH) occurs when the thyroid gland fails to develop or function properly and does not make adequate amounts of thyroxine.

  Most commonly, hypothyroidism is caused by a thyroid gland that is abnormally located (ectopic), absent, underdeveloped or severely reduced in size (hypoplastic). In these cases, the disorder is deemed to be sporadic (it occurs for no known reason).

  Less commonly, the thyroid gland is present but does not produce thyroxine because of an enzyme deficiency (dyshormonogenesis). In these cases the disorder is autosomal recessively inherited.

  Thyroxine plays an important role in regulating brain development, growth and metabolic rate. A lack of thyroxine in the first few years of life will lead to developmental delay, and can lead to poor growth and short height. Other effects are low body temperature, tiredness and constipation.

  A baby with congenital hypothyroidism may have no obvious symptoms. However, some babies may be very sleepy and feed slowly. They may also have prolonged jaundice or a tendency to be constipated.

  Early intervention can prevent the damage that may be caused by the disorder, and babies correctly treated with thyroxine can grow and develop normally.

  Screening
  Blood is tested for levels of thyroid stimulating hormone (TSH). Babies with low levels of thyroxine produce elevated levels of TSH. If the test result shows high levels of TSH, a confirmatory TSH test is performed.

  Action
  Slightly abnormal result
  If LMCs receive a letter from the laboratory advising of a slightly abnormal TSH result, they should:

  • contact the laboratory if they require further information
  • contact the family and inform them of the screening result
  • evaluate the baby: although they may display no obvious symptoms, they may be very sleepy and feed slowly, be constipated, or have prolonged jaundice
  • with family consent, take a repeat sample and send it to the laboratory as soon as possible
  • support the family by providing information about the reasons for a slightly abnormal result, and the disorder
  • notify the family of the results of the repeat sample.

  Significantly abnormal result
  If LMCs are phoned by the laboratory and informed of a significantly abnormal TSH result, they should:

  • follow any advice given by the laboratory
  • arrange a paediatric referral (if not organised by the laboratory)
  • contact the family immediately and inform them of the screening result and the arrangements for paediatric assessment
  • support the family by providing information about the reasons for a significantly abnormal result, diagnostic testing and the disorder. An information sheet for parents is provided by the laboratory.

  Treatment
  Babies with CH are cared for by a paediatrician (usually an endocrinologist). Treatment involves a daily oral dose of thyroxine for life (this is given to babies as a suspension), in sufficient quantities to bring thyroxine levels up to normal.

  Thyroxine levels are monitored with regular blood tests, usually weekly for six weeks then monthly until one year of age, and the thyroxine suspension is given in different amounts, depending on the blood results.

  Thyroxine treatment in the correct dose is very effective, and has no known adverse effects.

  The ‘Guidelines for practitioners providing services within the Newborn Metabolic Screening Programme’, are available on this website.

• Informed consent key to antenatal screening for Down syndrome and other conditions

  The newly introduced quality improvements to antenatal screening for Down syndrome and other conditions rest on the informed consent process. The main focus of the guidelines and education around the offer of screening is that women are given enough information to make an informed decision about whether to embark on the antenatal screening pathway. A robust informed consent process empowers women by providing the information and giving them the confidence they need to make that decision. Women also need to know that antenatal screening is voluntary and that they have the right to change their mind at any time. 
   
  Women need to be fully involved in the process. They need to understand the nature of screening, the limitations of screening, the importance of timing, the conditions screened for and what screening results might mean if screening indicates that their baby has an increased risk of a condition. Women also need to know what diagnostic testing options are available in a region, the risks inherent in these, the potential benefits and harms of screening and where further information, resources and support are available. 

  Some women will opt not to be screened because they choose to find out about their baby when he or she is born. Others will participate in screening with the intention of getting as much information as possible about their baby before the birth. This approach can help woman prepare for the birth of a baby that may have special needs. 

  All pregnant women presenting for maternity care prior to 20 weeks’ gestation should be offered access to antenatal screening for Down syndrome and other conditions.  Their participation however is a personal choice and this choice must be respected.

  To accompany the introduction of these screening options the NSU has developed and distributed guidelines for maternity providers offering antenatal screening for Down syndrome and other conditions in New Zealand, and a supporting laminated summary sheet. These are intended to encourage consistency of messages, with the aim of offering women information and choice in the care and management of their pregnancy. Also developed to support practitioner discussion with women are consumer pamphlets about the first trimester combined or second trimester maternal serum screening options, along with information about understanding an increased risk result.

• Identifying hearing loss in babies

  

  Each year, it is estimated that between 135 and 170 babies are born in New Zealand with mild to profound permanent congenital hearing loss. This represents a birth incidence of approximately three babies with a hearing loss per one thousand births.

  The first six months of a baby’s life is a critical period for learning communication. Lack of exposure to language during this time can affect a child’s development, communication skills, educational and career achievements. The early detection of hearing loss, and the application of early interventions, has been demonstrated to significantly improve long-term language skills and cognitive ability.

  The internationally recommended age for the diagnosis of hearing loss is before three months of age, with intervention commencing by six months. Before the introduction in this country of the Universal Newborn Hearing Screening and Early Intervention Programme (UNHSEIP), the average age of diagnosis in New Zealand was around three to four years of age.

  The UNHSEIP, introduced in 2007, will be in place in all 21 District Health Boards (DHBs) by July 2010. The programme aims to identify newborn babies with hearing loss early, so they can be given help and support as soon as possible.

  Kylie Bolland (MNZAS), the charge audiologist at Hutt Valley District Health Board, performs diagnostic audiology for babies as part of the UNHSEIP. She says finding out their baby has hearing loss can be extremely traumatic for parents.

  “When hearing loss is diagnosed in older children, it can sometimes be a relief for parents to finally know the cause of their child’s behavioural issues, or delayed speech and language development. But with a young baby who outwardly appears completely healthy, it is a big shock. And everything can seem to happen very quickly – we aim for screening to have been undertaken by one month, diagnosis by three months, and intervention by six months.

  “It is sometimes very hard for parents to take in what we are telling them; it can often take several appointments to go through what their baby’s hearing loss means, and their choices from there.”

  Kylie says those choices may include the baby being fitted with a hearing aid, having a cochlear implant when they are slightly older, and/or learning New Zealand sign language.

  “The options are different for each baby, depending on their level of hearing loss and their particular needs.”

  Kylie says once hearing loss is diagnosed, the child will see an audiologist every few weeks, with those visits becoming less frequent as they get older.

  “The audiologist becomes an important part of the life of that child and family. In the early stages an audiologist –usually with an adviser on deaf children – will see the child every three or four weeks, depending on the needs of the family and how they are managing. After that, visits get less frequent – the child may see an audiologist once a year when they are school-aged.”

  She says identifying hearing loss in babies is very challenging.

  “Unlike with older children, hearing loss in babies is invisible – the baby can’t tell you what’s wrong. That’s why diagnosing hearing loss in a young baby takes so much skill on behalf of the audiologist. Prior to the introduction of screening, the age of detection of hearing loss has been very high, so most audiologists are not experienced in diagnosing significant hearing loss in newborns. It is therefore essential to provide education to all audiologists involved in the testing and ongoing support to ensure a high-quality and successful programme.”

  There are two types of screens for babies, and one or both of these may be used. The first is Automated Otoacoustic Emissions or AOAE, where a small soft-tipped earpiece is placed in the baby’s ear. This makes clicking sounds of different pitches and a computer shows how the baby’s brain responds to the sound.

  The second method is Automated Auditory Brainstem Response or AABR, during which the same soft sounds are played through ear cups. The response from the baby’s hearing nerve is picked up through special sensors placed on their head.

  Both types of screens are painless and are undertaken when the baby is settled or asleep.

  Catherine Moran, a senior lecturer in communication disorders at the University of Canterbury, is managing the upskilling of audiologists who carry out screening as part of the UNHSEIP.

  The aim of the upskilling is to help ensure audiologists have the high level of skill required to diagnose hearing loss in babies. The courses, held in Auckland and Christchurch, are provided by the University of Canterbury, and funded by the Ministry of Health. They begin in April.

  “The upskilling programme is being offered in three phases. The first phase is an online component; followed by hands-on workshops, including international experts and some work with babies. Finally, there is regional follow up, which provides an opportunity for participants to practice their skills, and discuss their experiences and any issues with other audiologists and the international experts, who will be on-line.

  “Because screening babies for hearing loss is so different from screening slightly older children, audiologists will gain a great deal from the courses. The programme provides really valuable, practical skills for diagnosing hearing loss in babies.

  “DHBs have been encouraged to put their audiologists forward for the courses, and we’re really pleased with the uptake.”

  For further information about the upskilling programme, contact Vickie Rydz at the NSU on 09 580 9086; or email vickie_rydz@moh.govt.nz.
  

• The use of thermography as a breast cancer screening or diagnostic tool

  

  BreastScreen Aotearoa (BSA) would like to remind health practitioners that the use of thermography as a breast cancer screening or diagnostic tool is not supported by the NSU, the Cancer Society of New Zealand and The New Zealand Breast Cancer Foundation as there is insufficient evidence to do so.

  BSA is concerned that women who undergo thermography may delay visiting their doctor with a significant symptom, and/or having a mammogram because they believe thermography is an adequate replacement.

  An independent review of international literature on the effectiveness of thermography, carried out in 2003, concluded that the evidence currently available does not provide enough support for the role of infrared thermography for either population screening or diagnostic testing of breast cancer.

  These conclusions are consistent with recommendations of other key professional groups. The Royal Australian and New Zealand College of Radiologists Breast Imaging Reference Group does not recommend the use of thermography for the early detection of breast cancer. Similarly, the American Medical Association states that the use of thermography for diagnostic purposes cannot be recommended.  Thermography is not used in either the United Kingdom or Australian breast cancer screening programmes. The International Agency for Research on Cancer states that “the sensitivity and specificity of thermography are poor, and its application to screening is unlikely”.

  Health providers offering thermography to women must fully inform them of the potential harms, including the likelihood of false negative and positive results, how much it costs, and the lack of proof of its effectiveness as a screening tool. Thermal imaging is only a physiological measure and therefore must be used only as a supplementary test to screening mammograms.

  Women aged 45 to 69 are encouraged to take advantage of New Zealand’s free national breast screening programme. Unlike thermography, screening offered as part of the BSA programme is proven to reduce a woman’s risk of dying of breast cancer. Also unlike thermography, it is free to women aged 45 to 69.

  Women wanting to find out more about BSA, join the programme, or make an appointment can call 0800 270 200, or go to www.breastscreen.govt.nz. The joint position statement on thermography can be downloaded from the NSU website.

• Antenatal and newborn screening media activities

  

  The NSU has implemented a programme of media activities to encourage women to access maternity care early in their pregnancy. The activities are being led by the antenatal and newborn screening programmes^* within the NSU. The primary target audience is pregnant Maori and Pacific women, as these groups tend to access maternity services, including screening, later than other women. Early presentation is important if women are to receive the most benefit from screening and other antenatal support.

  The media encourages early access to information so informed decisions can be made, and emphasises that it is the individual’s choice whether or not to participate in screening. The programme runs from March through to the end of June 2010, using the following media:

  • Radio: Nui FM, Mai FM, Flava and the Maori Media Network. This will provide nationwide coverage. Radio activity will run one week per month for four months.
  • Women’s magazines: Full page placements will be made in NZ Woman’s Weekly and Woman’s Day magazines, as these have the largest readership in the target groups. 
  • Bounty ‘Your Pregnancy’ Pack: The antenatal and newborn screening time-line will be included in the Bounty, ‘Your Pregnancy’ Pack. The pack is received by 97 percent of expectant parents. Approximately 5,000 packs per month will have the timeline inserted.
  • Search Engine Marketing: via ‘Google’ as the most commonly used search platform in New Zealand. Approximately 200-500 click throughs to the NSU website are anticipated.

  The creative material is available to view on this website.

  *Antenatal HIV Screening Programme, the Quality Improvements for Antenatal Screening for Down Syndrome and Other  Conditions, Newborn Metabolic Screening Programme, Universal Newborn Hearing Screening Programme.