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Preference: Obstetrics and gynaecology and women's health

663

Chronic Ayurvedic medicine use associated with major and fatal congenital abnormalities

Although there are potential associations between lead exposure during pregnancy and adverse pregnancy outcomes, there are limited data on whether in-utero lead exposure is associated with major congenital abnormalities. We describe a case of a major congenital renal abnormality, which resulted in severe pulmonary hypoplasia and neonatal death, that was potentially associated with maternal chronic lead ingestion via an Ayurvedic medicine throughout pregnancy.

Clinical record

A 28-year-old primigravida was referred to a maternal–fetal specialist because a fetal ultrasound at 20 weeks showed oligohydramnios, absence of the right kidney and a small echogenic left kidney with poor corticomedullary differentiation, and intrauterine growth restriction. She had a history of lethargy throughout her pregnancy and a normocytic anaemia with a haemoglobin level of 95 g/L (reference interval [RI], 97–148 g/L) at 24 weeks’ gestation and 88 g/L (RI, 95–150 g/L) at 30 weeks’ gestation. Her white cell count and platelet count were normal at 24 weeks’ and 30 weeks’ gestation. Liver and renal function test results, and serum vitamin B12, folate and ferritin levels were also within normal limits at both 24 weeks’ and 30 weeks’ gestation. Chorionic venous sampling performed at 24 weeks did not detect any significant genomic abnormalities. At 30 weeks’ gestation, the maternal blood film showed basophilic stippling and her blood lead level (BLL) was high at 3.2 μmol/L (RI, < 0.48 μmol/L) or 67 μg/dL (RI, < 10 μg/dL). The toxicology unit was consulted and chelation was commenced, including oral dimercaptosuccinic acid (DMSA) at a dose of 10 mg/kg three times a day for 5 days followed by 10 mg/kg twice daily for 14 days. Three weeks after chelation, her BLL was 0.7 μmol/L (14.4 μg/dL).

For the previous 6 months, the patient had been taking two tablets per day of an Ayurvedic medicine, prescribed by a practitioner in India, that she was self-importing to Australia. Analysis of these tablets (performed by DTS Food Laboratories, a National Association of Testing Authorities-accredited laboratory) using inductively coupled plasma mass spectrometry, a process used to detect metals and non-metals, showed a lead content of 47%, small amounts of mercury (1.7%), and arsenic (< 0.01%). Urine arsenic and mercury levels were within normal limits. No other sources of lead exposure or ingestion were found.

Fetal growth improved after chelation therapy commenced; however, further ultrasound scans of the fetus showed diminished left renal tissue with progression to anhydramnios by 30 weeks’ gestation. By 34 weeks’ + 5 days’ gestation, there was no fetal renal tissue visible on ultrasound. The family received extensive counselling from the neonatal and renal specialists and the paediatric toxicologist, with consideration as to whether to dialyse the baby if chelation was needed and if the expected related respiratory failure was considered survivable postnatally.

Three days before an elective caesarean section at 39 weeks, the mother received intravenous calcium disodium edetate 40 mg/kg twice daily to decrease her lead concentrations before delivery. She gave birth to a 3.14 kg baby who had severe hypoxic and hypercapnic respiratory failure and a small right pneumothorax as a result of pulmonary hypoplasia, and severe contractures with bilateral dislocated hips, each resultant of the antenatal anhydramnios. The baby did not have typical facies of Potter sequences or other congenital abnormalities associated with Potter syndrome. Renal ultrasound showed no left renal tissue and a severely dysplastic right kidney of 1 cm diameter. The cord BLL at delivery was low at 0.37 μmol/L (8.0 μg/dL). Given the low BLL, chelation was not initiated. The baby died 2 days later from severe respiratory failure owing to poor antenatal pulmonary development, a result of the severe renal dysgenesis. At autopsy, the BLL was 0.55 μmol/L (11.5 μg/dL) and there was severely hypoplastic and multicystic renal tissue bilaterally (right kidney, 15 g; left kidney, 16 g), with normal ureters and bladder. Three weeks’ postpartum, the mother’s BLL was 0.8 μmol/L (17.3 μg/dL).

Discussion

Anaemia during pregnancy is common and iron deficiency is a common cause. However, normocytic anaemia in the absence of other causative factors requires further investigation using blood film analysis. Basophilic stippling on blood film is associated with lead toxicity, arsenic toxicity, thalassaemia, sideroblastic anaemia, thrombotic thrombocytopenic purpura and hereditary pyrimidine 5′-nucleotidase deficiency.1 The combination of basophilic stippling with unexplained anaemia needs further investigation, and questions regarding potential sources of lead or arsenic exposure need to be asked. Other common sources of lead include occupational exposure, fishing sinkers, old paint (before 1960), retained bullets and pottery.

During pregnancy, chronic lead toxicity can present with anaemia and lethargy, peripheral neuropathy, hypertension, liver and renal dysfunction, abdominal pain and, in severe cases, encephalopathy.2 Long-term effects on maternal and fetal IQ are also a concern.

Lead crosses the placenta at as early as 12–14 weeks’ gestation and is mobilised from maternal bone during the formation of the fetal skeleton. Studies have shown that 85% of cord BLLs come from maternal bone stores.2 Although there are potential associations between lead exposure during pregnancy and adverse pregnancy outcomes, including spontaneous abortion, pregnancy-related hypertension, low birth weight and neurobehavioural development, the literature is less clear on whether there is an association between major congenital abnormalities and lead toxicity during pregnancy.2,3

One case report describes an asymptomatic female worker with occupational lead exposure who had a BLL of 62 μg/dL at 8 weeks’ gestation and was removed from exposure with a reduction of BLL to 5 μg/dL at 14 weeks’ gestation. The infant developed VACTERL association (vertebral anomalies, anal atresia, cardiac defects, tracheo-esophageal fistula and/or esophageal atresia, renal and radial anomalies, and limb defects); it was not possible to determine whether this was caused by the lead toxicity.4 Another case involved a mother with a BLL of 31 μg/dL at 21 weeks’ gestation from a retained bullet. There were neurological, cardiovascular and pulmonary abnormalities at birth but no functional abnormalities at 10 years of age.5

In our case, the mother had been taking Ayurvedic medication for 6 months spanning the period before pregnancy and during the first trimester during organogenesis. The baby had renal abnormalities (agenesis of one and absence of the other kidney), along with pulmonary hypoplasia and anhydramnios. The risk of nephrotoxicity increases proportionally with increasing BLL, and effects on glomerular filtration have been reported at a BLL < 20 μg/dL.6 Although it is not possible to be certain that these abnormalities were caused by the lead toxicity, a high BLL was present on investigation.

Evidence for chelation therapy for lead toxicity during pregnancy is limited to animal data and case studies.2 Removal from ongoing exposure is key to the treatment of any patient with heavy metal toxicity. DMSA was administered in this case and there have been conflicting animal studies on whether DMSA increases the risk of fetal toxicity secondary to lead or whether it significantly reduces the lead concentration without harm. Chelation during the first trimester is controversial because this is the period of organogenesis; therefore, the potential benefit of chelation has to be balanced against the unknown risks of the chelation agents on fetal outcome. Generally, unless the mother is encephalopathic or has other markers of severe lead toxicity, chelation would be deferred until at least the second trimester.7 In our case, consideration was given as to which chelating agent, if needed, could be used for the baby. Given the fetus and baby had minimal kidney tissue, an intravenous chelating agent may have caused nephrotoxicity through deposits of chelation complexes. Oral succimer via a nasogastric tube was to be the chelating agent of choice, as it would not have those same concerns of nephrotoxicity.

The popularity of traditional medicines has been increasing in Asia, North America and Australasia.8 Ayurveda is the most widely practiced traditional medicine system on the Indian subcontinent. The addition of heavy metals into Ayurvedic preparations may either be purposeful or a result of contamination. During pregnancy, there is an increased recommended iron intake of 50% compared with that for women of childbearing age. The number of women substituting Ayurvedic medicine for iron supplementation during pregnancy and to what extent is unknown. In a study from the United States, an analysis of 70 Ayurvedic products showed that 14 (20%) contained enough heavy metals to be over the recommended maximum amounts.9 There is existing legislation to help regulate the provision of Ayurvedic and herbal medicines in the United Kingdom and the US. In Australia, the Therapeutic Goods Administration (TGA) allows listing of complementary medicines if the names of the ingredients are provided to the TGA; however, testing of content (eg, for safety) is not required for such listing.10 In addition, the purchase of these medications for personal use from overseas and their availability over the internet can prove challenging to monitor.

Health care practitioners and consumers need to be aware of the potential for heavy metal toxicity to be associated with the use of Ayurvedic medications. A focused drug history including traditional remedies should be undertaken in all patients. Pregnant patients need to know the side effects of medications prescribed throughout pregnancy and the risks associated with taking complementary medicine, especially given the “loopholes” in content testing by regulatory agencies not only in some countries overseas but also in Australia.

[Editorial] Adolescent health: boys matter too

It has been a good year for adolescents. Many global health reports and initiatives now mention adolescents. So also does the latest UN Population Fund’s State of the World Population 2015 report, released on Dec 3. Shelter from the Storm: a transformative agenda for women and girls in a crisis-prone world reminds us that there are 26 million women and adolescent girls in their childbearing years in need of humanitarian assistance worldwide. During the past 2 years or so, adolescents have been increasingly included in the women’s and child health agenda, culminating in UN Secretary-General Ban Ki-moon’s updated Global Strategy for Women’s and Children’s Health into the Global Strategy for Women’s, Children’s and Adolescents’ Health (2016–2030), presented on Sept 26 at the General Assembly.

Gatekeeper role of GPs under scrutiny in MBS review

The crucial gatekeeper role played by GPs is coming under scrutiny as the Federal Government explores a possible overhaul of the operation of Medicare as part of its review of the MBS.

While around 35 Clinical Committees will be set up to conduct an item-by-item review of the MBS, a memorandum by Review Taskforce Chair Professor Bruce Robinson shows “high-level” issues affecting the overall functioning of the Medicare system are also under active consideration.

The Review Chair was at pains to insist that there was no set savings target for the MBS Review, but added there was “a need to look at the full breadth of the $19.1 billion MBS spend, not just general practitioner services”.

His comments came as it was revealed the final results of the MBS Review would not be submitted to the Government until December 2016, almost certainly putting them beyond the next Federal election, which is due by late next year.

Much of the attention so far has been on the Review’s appraisal of more than 5700 items on the MBS, and the fact that it also encompasses an examination of the over-arching rules governing the operation of Medicare is less well known.

But the far-reaching possibilities this entails started to become clearer at a series of stakeholder forums organised by the Taskforce, including fundamental changes in professional roles and responsibilities, models of remuneration, and the use of the MBS to “actively guide” clinical decision-making.

In his report on consultations, Professor Robinson said some had complained that the gatekeeper role played by GPs was limiting the effectiveness of team-based care, such as by requiring all referrals to be made through the GP.

The Taskforce Chair said that though some participants reaffirmed the importance of GPs as gatekeepers, there were suggestions that specialists be able to make direct referrals in selected cases, such as a physiotherapist requesting a knee x-ray.

Suggestions of any dilution in the central role played by GPs in coordinating care fly in the face of the latest advice from health experts here and abroad, who have argued that, far from diminishing the position of the family doctor, governments should enhance it.

In its latest review of the Australian health system, the Organisation for Economic Cooperation and Development argued strongly against any further fragmentation of the health system, and urged that primary health care be strengthened.

And University of Sydney researchers last month reported that GPs were holding health costs down by coordinating the care provided by hospitals, specialists, allied health professionals and community and aged care services.

“If general practice wasn’t at the core of our health care system, it is likely the overall cost of health care would be far higher,” the researchers said.

The MBS Review process has also included discussion about a shift away from the fee-for-service remuneration model to pay for performance – an issue being explored in detail by the Primary Health Care Advisory Group being led by former AMA President Dr Steve Hambleton.

“While many participants felt the MBS could improve quality of care by paying for performance, concerns were voiced that clinicians may be averse to taking on high-risk patients who are unlikely to achieve target outcomes,” Professor Robinson reported. “Furthermore, some rebates may need to reflect the additional risk that providers would be taking on – potentially a complex analysis.”

In addition to exploring so-called ‘macro’ issues, Professor Robinson provided more detail on how the review of individual Medicare items would proceed.

He said each of the Clinical Committees would conduct an initial “triage” of usage patterns, evidence and descriptors to identify items in need of more detailed investigation.

It would then conduct a rapid evidence review and make recommendations to the Taskforce based on its appraisal.

Given the scale of the task, Professor Robinson said the Committees, which would be peer-nominated and clinically-led, would be likely to appoint subsidiary working groups.

Already, six pilot Clinical Committees have been established, including in obstetrics.

The Taskforce Chair said items suggested for review fell into one of six categories: they were obsolete, misused, under-utilised, placed undue restrictions on providers or did not reflect modern practice.

He said participants stressed the importance of Taskforce plans to share the evidence used to support recommendations about items, to improve clinical practice and inform the future direction of research.

The Review Taskforce is due to provide an interim report to the Government by the end of the year.

Professor Robinson’s Memorandum of the MBS Review Taskforce November 2015 Stakeholder Forums can be viewed at: sites/default/files/Summary%20Memorandum%20MBS%20Review%20Stakeholder%20Forums%20November%202015%20%282%29.pdf

Adrian Rollins

 

Continuous quality improvement and metabolic screening during pregnancy at primary health centres attended by Aboriginal and Torres Strait Islander women

Attending to perinatal risk factors, such as diabetes and hypertension during pregnancy, obesity and excess gestational weight gain,1–5 is important for optimising maternal and infant health outcomes. Pregnancy is also a key period for implementing strategies that prevent long-term adverse health outcomes, as excess gestational weight gain and gestational diabetes mellitus (GDM) are respectively predictors of long-term obesity6 and the development of type 2 diabetes.7

Screening for and follow-up of metabolic risk factors are components of recommended pregnancy care in Australia.8 Ensuring that Aboriginal and Torres Strait Islander (respectfully referred to in this article as Indigenous) women receive such care is expected to contribute to giving babies a healthy start to life and to improving the health of their mothers. In Australia, low birth weight, premature birth and perinatal death are substantially more frequent in Indigenous than in non-Indigenous pregnancies.9 Obesity, pre-existing diabetes and GDM are some of the risk factors that are more common in Indigenous women.3,4,10 Later in life, cardiovascular disease and diabetes are major contributors to the difference in life expectancy between Indigenous and non-Indigenous Australians.11

As care can differ between health centres with different characteristics, such as urban and rural or remote locations,8 effective long-term strategies are needed across a range of settings to facilitate the provision of all components of recommended pregnancy care.12 The Audit and Best Practice for Chronic Disease (ABCD) National Research Partnership13,14 aims to improve the provision of care by primary health care centres (PHCs) serving mainly Indigenous populations. It uses a continuous quality improvement (CQI) framework to increase the efficiency and effectiveness of organisational systems. Previous ABCD Partnership research indicates that increases in self-ratings of organisational systems are associated with improvements in the delivery of health care for those with type 2 diabetes.15

We investigated screening for metabolic risk factors during pregnancy and follow-up actions by PHCs participating in the ABCD partnership. We also investigated associations between self-ratings by organisational systems and the proportion of women who undergo metabolic screening.

Methods

The study was approved by human research ethics committees in the relevant states and territories, and by Indigenous subcommittees where required.16 The analyses were approved by the Monash University Human Research Ethics Committee (CF12/3434-2012001670).

Study design and setting

The ABCD National Research Partnership study protocol has been described in detail elsewhere.13,16 This partnership links multiple PHCs and stakeholders across the health system in collaborative CQI research.14 One21seventy, the National Centre for Quality Improvement in Indigenous Primary Health Care, supports CQI in PHCs by providing evidence-based practical tools and training.14 The ABCD Partnership has access to One21seventy data from PHCs that have volunteered to participate in research.13,14 This article reports longitudinal analysis of data from 76 PHCs (2592 health records) involved in the ABCD Partnership across five Australian states and territories. The PHCs conducted up to four CQI cycles, comprising 58.5% (168 of 287) of the One21seventy maternal health audits conducted between 2007 and 2012. Twenty-one of the 76 PHCs began maternal health auditing in 2007; 13 commenced in 2008, 13 in 2009, 11 in 2010, 10 in 2011, and 8 in 2012. Depending on their needs, PHCs may focus in some years on CQI activities in other clinical areas; of 50 PHCs that had completed two or more maternal health audits, 11 (22.0%) conducted audits in non-consecutive years.

Intervention: continuous quality improvement cycles

At baseline, systems assessments and audits of health records were conducted and the results provided to PHCs in real-time by an automated CQI reporting system. PHCs use the reports for participatory interpretation and goal setting, and this is followed by the initiation of relevant actions. Data collection was repeated in subsequent years to assess success in improving care (end of cycle 1), and to identify new priorities for improvement (start of cycle 2). PHCs are encouraged to complete one cycle each year.

Maternal health audit tool

Recorded pregnancy care was assessed by auditing the health records of women with a recent pregnancy (mothers with an infant aged 2–14 months, who resided in the community during their pregnancy and attended for pregnancy care at least once).13,16 Audits were conducted by trained auditors (local PHC staff, staff from other PHCs, or CQI facilitators) supported by a standard protocol and regional CQI facilitators. The audit tool and parameters of the outcome measures were based on best practice guidelines, policy and research reports, and stakeholder consultations.16 At each PHC, the auditor used a standard sampling protocol to select a random sample of at least 30 records to audit (if fewer than 30 eligible records were available, all were audited).13

The Systems Assessment Tool

Structured assessments of PHC system strengths and weaknesses were conducted by PHC staff together with a trained external CQI facilitator using the Systems Assessment Tool (SAT).13,15 This consensus process produces a self-reported overall mean score (range, 0–11) for the state of development of PHC organisational systems, and five subscale scores (delivery system design, information systems and decision support, self-management support, external links, and organisational influence and integration).

Key outcome measures

The audit tool collected information on documentation of the following items in each health record:16

  • body weight, body mass index (BMI) and blood pressure (BP) screening in women attending at earlier than 13 weeks’ gestation;

  • BP checks at any point during the pregnancy;

  • a 50 or 75 gram glucose challenge test (GCT) and, if indicated, an oral glucose tolerance test (OGTT) at 20–30 weeks’ gestation;

  • for women with a BMI under 20 or over 30 kg/m2: development of a BMI management plan;

  • for women with high BP (≥ 140/90 mmHg): repeated BP measurements, urine tests for protein, examination by or referral to a general practitioner or obstetrician, or prescription of anti-hypertensive medication;

  • an OGTT for those with an abnormal GCT result (plasma glucose concentration ≥ 7.8 mmol/L 1 hour after a 50 g glucose load (morning, non-fasting), or ≥ 8.0 mmol/L after a 75 g glucose load).

“Follow-up” in this article refers to taking the next appropriate action after an abnormal screening result.

Statistical methods

Analyses were conducted using Stata version 12.1 (StataCorp). P < 0.05 (2-sided) was defined as statistically significant. Differences in screening proportions at baseline and at the final audit were assessed with respect to PHC governance, location, population size (t tests or Mann–Whitney U tests) and state or territory (one-way analysis of variance or Kruskal–Wallis tests). Paired t tests assessed differences between the first and last SAT scores. Using each health record as the unit of analysis, random effects logistic regression analysis (generating odds ratios) assessed any associations between metabolic screening and CQI cycle number (Stata xtlogit command). Random effects logistic regression allowed for repeated measures of each outcome (eg, did a patient receive a BP check: yes or no) at each cycle per PHC. This method also allowed for adjustment for similarities in women within each PHC. The reference group comprised audit data from the PHCs before they had conducted a CQI cycle (ie, cycle 0 or baseline). We also tested for a trend to increased metabolic screening with each additional CQI cycle (Stata nptrend command).

For each PHC, the proportion of women receiving screening after each CQI cycle was calculated. Treating each PHC as the unit of analysis, univariable linear regression (generating β coefficients) assessed associations between:

  • the average proportion of women who underwent screening across all cycles, and average overall or subscale SAT scores;

  • the total change (from first to final cycle) in the proportion of women who underwent screening, and the total change in overall or subscale SAT scores.

Results

A range of PHC settings were included in the study. Most women who attended these PHCs for pregnancy care were Indigenous Australians (87.9%) (Box 1).

While most women who attended during the first trimester were weighed, the BMI was calculated for less than a third; but women attending after the PHC had conducted at least one CQI cycle were more likely to have had their BMI assessed than women attending PHCs that had not done so. Similar patterns were observed for BP checks at any point during the pregnancy and diabetes screening. Improvements in screening appeared to be sustained over sequential CQI cycles, and there were trends for additional improvements with each additional cycle (Box 2).

At baseline, the only significant differences in screening were those between states and territories for first trimester BP checks (P = 0.04), BP checks at any stage of the pregnancy (P = 0.02) and diabetes screening (P = 0.002). These differences were not significant at the PHCs’ final audits (all P > 0.05).

There were also indications of sustained improvements in the provision of follow-up actions after CQI participation, but the sample sizes were too small for statistical analysis. Follow-up actions for high BP included repeated BP assessment (pre-26 weeks, 88.1%; post-26 weeks, 91.9%), urine tests (pre-26 weeks, 88.1%, post-26 weeks, 83.9%), referral (pre-26 weeks, 85.7% post-26 weeks, 94.3%) and antihypertensive medication (pre-26 weeks, 42.9%, post-26 weeks, 26.4%). Follow-up OGTTs were reported for most women who received an abnormal GCT result. Few women with an abnormal BMI, however, had a documented BMI management plan (Box 3).

Systems assessment data were available for 35 PHCs (46.1%); data were available for more than one time point for 21. The mean overall SAT score at the final cycle (7.36) was statistically significantly higher than at the first cycle (6.23; P = 0.009), but there were no significant differences in SAT subscale scores between the first and final cycles (data not shown). Higher average self-ratings of some organisational systems were associated with greater provision of metabolic screening (Box 4). For example, the average provision of first trimester BP screening was 3.7 percentage points higher for each additional point scored on the SAT information systems and decision support domain. Diabetes screening was associated with higher overall self-ratings, as well as with higher ratings of self-management support systems, and of organisational influence and integration.

In addition, there was a statistically significant association between a one-point increase from first to final assessment in information systems and decision support scores and an increase of 5.7 percentage points in the proportion of women receiving diabetes screening between the first and final audits (β = 5.7; 95% CI, 0.6–10.9; P = 0.03). However, no other significant associations between changes in SAT scores and screening were detected (data not shown).

Discussion

This large longitudinal study of PHCs found substantial improvements in routine metabolic screening in pregnancy associated with participation in a CQI initiative. Improvements were sustained over multiple cycles, with evidence for additional improvements with each consecutive CQI cycle. Initiation of follow-up actions also improved after CQI participation. Higher self-ratings of some organisational systems were significantly associated with greater metabolic screening.

Screening at baseline was incomplete for all the metabolic risk factors investigated, consistent with reports from other Indigenous communities.17 It is unclear whether metabolic screening coverage in other maternity care settings is incomplete, as this information is not reported in other routine perinatal data collections. However, improvements associated with CQI participation were observed with respect to BMI and BP assessment and screening for diabetes during pregnancy. Measurement of BMI early in pregnancy is important because maternal and neonatal morbidity increases with maternal BMI,3 and the recommended gestational weight gain depends on the BMI category.1 Measurement of BMI may be influenced by both the mothers’ and health professionals’ understanding of the importance of healthy gestational weight gain and awareness of weight gain guidelines, and by the confidence of health professionals that they can discuss weight with women without causing undue concern.18 It is encouraging that we encountered no instances of women who declined to be weighed. Similarly, first trimester BP assessment and universal second trimester GDM screening are also recommended in Australia, and these remain areas for improvement. It is important to explore potential barriers to GDM screening, both because the prevalence of diabetes during pregnancy is higher among Indigenous women than in non-Indigenous women4 and because of the importance of diabetes management during pregnancy.4

Pregnancy is an opportune time for health practitioners to discuss weight management with women.19 However, few women in this study with an abnormal BMI had a management plan, which may reflect suboptimal action taken, a lack of documentation of the actions taken, or both. Excess weight gain increases pregnancy risks, such as macrosomia, preterm birth and the need for caesarean delivery,1 as well as the long-term risk of obesity,6 making active management vital for the wellbeing of mother and child. Potential barriers to developing weight management plans include limited resources for referral, food security concerns, and inadequate staff time, especially in remote communities. Development of resources or programs for gestational weight management tailored to the needs of Indigenous women may assist.

Most women with an abnormal GCT result subsequently underwent a diagnostic OGTT. Recent controversy about diabetes screening20 may have created barriers to screening and follow-up. While large-scale implementation of the International Association of Diabetes in Pregnancy Study Group guidelines, starting in 2015,21 may partially resolve these problems, the number of women diagnosed with GDM will also increase,22 with potential resource implications for PHCs.

The positive associations between self-ratings of organisational systems and first trimester BP and diabetes screening in our study support targeting of organisational systems as a strategy for improving the provision of metabolic screening during pregnancy. However, further large-scale improvements in systems and processes that support health professionals in conducting metabolic screening and management are vital if the long-term consequences of these complications in pregnancy are to be reduced. We hope that our findings encourage further discussion about how pregnancy care for Indigenous women might be improved. All levels of the health system have roles to play, and systems-based research networks, such as the ABCD Partnership, are ideally placed to develop appropriate strategies.

Our study was limited by the fact that SAT data were available for only some PHCs (35 of 76, 46.1%), reducing the statistical power of our analysis to detect associations. Selection bias was also possible, as this study included only the One21seventy PHCs that volunteered their data for research (58.5% of the audits conducted overall). Our data may not be representative of PHCs not participating in the One21seventy initiative, but this extensive network includes a large population, and there are currently no other comparable data sources in Australia. Bias caused by the possibility that PHCs with lesser improvement would be less likely to remain in the CQI initiative is difficult to gauge, as commencement years varied and PHCs may have conducted maternal health audits in non-consecutive years. However, the generalisability of our results may have been enhanced by the fact that PHCs used the audit tool according to their needs, rather than as a research requirement. As we performed multiple statistical tests, there was a risk of finding significant associations by chance. This possibility was reduced by not undertaking statistical tests for follow-up actions, as the small numbers involved were inadequate for meaningful comparisons.

The CQI initiative continues, and further assessment of its effects on service delivery and health outcomes is planned as the sample size increases. Future directions include investigating the effects on service provision of the audit year, the year of commencement, and the duration of CQI participation. A cluster randomised controlled trial is an alternative study design that could be used to test hypotheses arising from the current findings.

Despite the limitations, our study has significant strengths that increase the generalisability of its findings. Most previous CQI research in pregnancy care has been hospital-based, implemented in a single service, not focused on metabolic screening, or not conducted in Australia.23–25 Our research applied a unique system-wide participatory approach to assess systemic issues commonly affecting provision of care.14 It used a detailed, longitudinal dataset to investigate long-term sustainability, and included many PHCs across several settings.

Our study shows the potential of a CQI initiative supported by a systems-based research network to improve the provision of recommended pregnancy care at PHCs attended by Indigenous women. These findings are encouraging, and suggest a successful approach for achieving further improvement in pregnancy care provision.

Box 1 –
Characteristics of the 76 primary health care centres included in the study, and of the 2592 women whose records were audited

Characteristics of the primary health care centres

Governance structure

Government-operated

49 (64.5%)

Community-controlled

27 (35.5%)

Location

Remote

56 (73.7%)

Urban or regional

20 (26.3)

Service population size

≥ 1000 people

39 (51.3%)

< 1000 people

37 (48.7%)

State or territory

Northern Territory

28 (36.8%)

Queensland

27 (35.5%)

Western Australia

11 (14.5%)

New South Wales

6 (7.9%)

South Australia

4 (5.3%)

Characteristics of the women

Indigenous status∗

2141 (87.9%)

Aboriginal

2028 (83.3%)

Torres Strait Islander

57 (2.3%)

Aboriginal and Torres Strait Islander

56 (2.3%)

Age†

Median, years

24.4 (IQR, 20.6–29.6)

< 20 years

545 (21.1%)

20–34 years

1807 (69.9%)

≥ 35 years

233 (9.0%)

First attendance for pregnancy care occurred before 13 weeks’ gestation‡

1321 (51.0%)

Median number of pregnancy care visits

7 (IQR, 5–10)

IQR = interquartile range. ∗n = 2435 (data missing for 157 women). †n = 2585 (data missing for 7 women). ‡n = 2591 (data missing for 1 woman).

Box 2 –
Documented metabolic screening during pregnancy after completion of each continuous quality improvement (CQI) cycle, and associations between metabolic screening and primary health care centre (PHC) participation in each CQI cycle

Metabolic screening

CQI cycle

P (for trend)

076 PHCs

150 PHCs

228 PHCs

38 PHCs

46 PHCs

Weight measured in first trimester (1321 women)

440/562 (78.3%)

344/418 (82.3%)

153/202 (75.7%)

49/65 (75.4%)

56/74 (75.7%)

Odds ratio (95% CI)

1.0

1.4 (0.9–2.0) P = 0.10

1.0 (0.6–1.6) P = 0.89

1.2 (0.6–2.4) P = 0.59

1.4 (0.7–2.8) P = 0.34

0.38

BMI calculated in first trimester (1321 women)

132/562 (23.5%)

126/418 (30.1%)

63/202 (31.2%)

25/65 (38.5%)

31/74 (41.9%)

Odds ratio (95% CI)

1.0

2.4 (1.6–3.5) P < 0.001

3.4 (2.0–5.6) P < 0.001

5.1 (2.4–10.7) P < 0.001

9.4 (4.6–19.4) P < 0.001

< 0.001

Blood pressure check in first trimester (1321 women)

485/562 (86.3%)

370/418 (88.5%)

180/202 (89.1%)

56/65 (86.2%)

59/74 (79.7%)

Odds ratio (95% CI)

1.0

1.3 (0.8–1.9) P = 0.27

1.5 (0.9–2.7) P = 0.15

1.6 (0.7–3.7) P = 0.24

1.1 (0.5–2.3) P = 0.78

0.51

Blood pressure check at any point during the pregnancy (2592 women)

1123/1201 (93.5%)

745/758 (98.3%)

383/388 (98.7%)

131/135 (97.0%)

110/110 (100.0%)

Odds ratio (95% CI)

1.0

3.7 (1.9–7.3) P < 0.001

7.0 (2.5–19.4) P < 0.001

2.0 (0.6–6.5) P = 0.25

—

< 0.001

Diabetes screening (2541 women)∗

669/1192 (56.1%)

469/736 (63.7%)

234/380 (61.6%)

86/135 (63.7%)

74/98 (75.5%)

Odds ratio (95% CI)

1.0

1.3 (1.0–1.6) P = 0.04

1.2 (0.9–1.7) P = 0.15

1.7 (1.1–2.6) P = 0.02

3.4 (1.9–5.9) P < 0.001

< 0.001

BMI = body mass index. ∗In 2010, the audit tool was refined to include “not applicable” if women had already been diagnosed with diabetes, or were offered but declined BMI or blood pressure assessment or diabetes screening. Since 2010, 26 women were recorded as having pre-existing diabetes, and 25 women declined diabetes screening. This reduced the denominator for diabetes screening to 2541. There were no recorded instances of women declining BMI or blood pressure checks.

Box 3 –
Recorded metabolic abnormalities during pregnancy and subsequent follow-up after each continuous quality improvement (CQI) cycle

Metabolic risk factors and follow-up

CQI cycle

0

1

2

3

4

76 PHCs

50 PHCs

28 PHCs

8 PHCs

6 PHCs

Abnormal BMI in first trimester (377 women)

39/132 (29.6%)

34/126 (27.0%)

17/63 (27.0%)

5/25 (20.0%)

8/31 (25.8%)

BMI management plan (103 women)

6/39 (15.4%)

10/34 (29.4%)

6/17 (35.3%)

4/5 (80.0%)

4/8 (50.0%)

High blood pressure in first trimester (1150 women)

11/485 (2.3%)

12/370 (3.2%)

5/180 (2.8%)

1/56 (1.8%)

0/59

Blood pressure follow-up < 26 weeks (73 women)

13/32 (40.6%)

17/27 (63.0%)

7/9 (77.8%)

2/2 (100.0%)

3/3 (100.0%)

High blood pressure at any time during pregnancy (2492 women)

72/1123 (6.4%)

51/745 (6.8%)

25/383 (6.5%)

2/131 (1.5%)

8/110 (7.3%)

Blood pressure follow-up ≥ 26 weeks (110 women)

34/49 (69.4%)

30/35 (85.7%)

17/20 (85.0%)

no cases

6/6 (100.0%)

Abnormal GCT result (1530 women)

120/667 (18.0%)

92/469 (19.6%)

41/234 (17.5%)

15/86 (17.4%)

9/74 (12.2%)

Follow-up OGTT (277 women)

104/120 (86.7%)

81/92 (88.0%)

40/41 (97.6%)

14/15 (93.3%)

7/9 (77.8%)

PHC = primary health care centre; BMI = body mass index; GCT = glucose challenge test; OGTT = oral glucose tolerance test.

Box 4 –
Associations between the average proportions of women undergoing metabolic screening and average Systems Assessment Tool scores (across all cycles) for 35 primary health care centres (β-coefficient, 95% CI)

Overall score

Delivery system design

Information systems and decision support

Self-management support

External links

Organisational influence and integration

BMI calculated in first trimester

4.2 (−3.5 to 11.9)

2.7 (−4.8 to 10.2)

5.5 (−1.3 to 12.2)

3.5 (−1.6 to 8.6)

1.9 (−4.5 to 8.4)

1.2 (−5.1 to 7.4)

Blood pressure check in first trimester

2.6 (−0.6 to 5.8)

1.9 (−1.3 to 5.0)

3.7∗ (0.9 to 6.4)

1.5 (−0.6 to 3.7)

−0.6 (−3.4 to 2.1)

2.5 (−0.0 to 5.1)

Blood pressure check at any point during pregnancy

0.9 (−0.9 to 2.6)

0.5 (−1.2 to 2.2)

1.3 (−0.2 to 2.9)

0.3 (−0.9 to 1.5)

0.3 (−1.2 to 1.8)

0.7 (−0.8 to 2.1)

Diabetes screening

5.3∗ (0.6 to 10.1)

4.6 (−0.1 to 9.3)

3.8 (−0.6 to 8.2)

3.4∗ (0.2 to 6.7)

1.2 (−3.1 to 5.4)

4.9∗ (1.1 to 8.6)

BMI = body mass index. ∗P < 0.05.

Breastmilk banking and the Mercy Health experience

Breastmilk banking provides an alternative to infant formula, not a substitute for mother’s own milk

Breastmilk banks collect, process, store and distribute donated human milk for hospitalised premature and growth-restricted infants. Pasteurised donor human milk (PDHM) as an alternative to artificial formula when mother’s own milk is unavailable is not a new concept. Before infant formula became widely available, milk sharing and wet nursing were common practices in Australian maternity wards in the 1940s. Concerns regarding transmission of infectious diseases in the 1980s saw breastmilk banks fall out of favour. With improved screening, storage and handling procedures, and evidence surrounding the importance of breastmilk in human development, breastmilk banking has re-emerged as a viable option when the supply of mother’s own breastmilk is insufficient. Insufficient supply may occur because of maternal illness, medications or difficulties in establishing or maintaining lactation. Some 450 breastmilk banks exist internationally and the numbers are rising.

Infant feeding guidelines from the World Health Organization1 and the National Health and Medical Research Council2 recommend exclusive breastfeeding for the first 6 months of life. When this is not possible, the alternatives are either expressed donor breastmilk or formula milk. Given that artificial formula cannot provide many benefits beyond basic nutrition, the American Academy of Pediatrics states that PDHM should be first choice for preterm infants when there is insufficient mothers’ own milk.3 Evidence shows that compared with formula, donor human milk is associated with a lower incidence of necrotising enterocolitis and other infections during initial hospitalisation.1

In Australia, five recognised facilities currently exist, led by the establishment of the Perron Rotary Express Milk Bank in 2006, at the King Edward Memorial Hospital in Western Australia. Although there are no universal Australian guidelines governing practice, most centres adhere to the 2010 United Kingdom National Institute for Health and Care Excellence (NICE) guidelines for the operation of donor breastmilk banks,4 which include donor screening recommendations. In 2014, the Australian government published an examination of donor human milk banking in Australia,5 comprehensively reviewing the evidence, quality assurance and regulatory issues surrounding risk management and quality control. The report concluded that voluntary regulation guided by existing legal frameworks is sufficient and appropriate.

Current international guidelines recommend pasteurisation of donor human milk to minimise the risk of disease transmission by inactivating most viral and bacterial contaminants. Additionally, screening is recommended for donors, similar to that for routine blood donation. Minimum serological standards include testing for HIV-1, HIV-2, hepatitis B and C virus, human T-lymphotropic virus types 1 and 2, and syphilis, as recommended by the Australasian Tissue Banking Forum.6

2015 marks the fifth year of operation for the Mercy Health Breastmilk Bank (MHBMB). As Victoria’s first breastmilk bank, founded in 2011, and the second largest of its type in Australia, this service continues to grow, providing for extremely sick and premature babies born at Mercy Hospital for Women in Melbourne.

Since conception in 2011, the MHBMB has collected over 1551 litres of PDHM, received from 162 mothers, supplying 276 babies. Following international criteria, neonates born before 34 weeks’ gestation or weighing less than 1500 g at birth are eligible for PDHM. Last year alone, over 254 litres of donor milk was consumed by babies cared for at Mercy Hospital for Women.

The MHBMB collects, screens, pasteurises and stores donor milk according to NICE guidelines. With parental consent, PDHM is available to babies in the special care nursery and intensive care unit, usually as a bridging supply until mothers’ own milk becomes sufficient. This donated milk provides preterm neonates with essential nutritional requirements for growth and neurological development, and human specific proteins and immunoglobulins for protection against infectious disease and immunity against other disorders.5,6

The MHBMB currently relies on donated breastmilk from mothers who have recently given birth at Mercy Hospital for Women. Our future hope is to include new mothers around Victoria and provide PDHM to eligible infants in other Victorian tertiary nurseries.

[Perspectives] Deeds not words

John Carey’s book The Intellectuals and the Masses reminds us that many upper-class liberals of the early 20th century thought that working class and people of colour were fundamentally inferior. Well aware of the trope “posh ladies in hats”, instead of focusing on suffragette leader Emmeline Pankhurst, the makers of Suffragette tell the story of women who work in a laundry as they chart the struggle for women’s voting rights.

Abortion laws need updating in line with fetal medicine advancements

Women whose babies are diagnosed with a fetal abnormality are being disadvantaged by Australia’s patchwork abortion laws, experts say.

Professor Caroline de Costa, from James Cook University, and Professor Heather Douglas, from the University of Queensland write about the barriers these women face in today’s Medical Journal of Australia.

“Medicare-funded diagnosis of fetal abnormality is now routinely offered to all pregnant Australian women — with the implication that a woman may choose to terminate the pregnancy if a serious abnormality is detected”, they write.

However they say that abortion laws haven’t kept pace with these developments.

Abortion is decriminalised in ACT, Victoria and Tasmania with various timeframe restrictions.

“Fetal abnormality is specifically discussed in the legislation in Western Australia, South Australia, Tasmania and the Northern Territory, and covered by the decriminalisation of abortion in Victoria and the ACT; in practice, however, late abortion is restricted by health regulations in WA, SA and the NT”, de Costa and Douglas write.

Related: MJA – Termination of pregnancy: a long way to go in the Northern Territory

“In Queensland and New South Wales, the law does not refer to fetal abnormality at all.”

They are concerned these difference in laws could lead to extensive abortion ‘tourism’ to states that are decriminalised.

“In 2015, there is an urgent need for legislative uniformity across Australia so that the law is in step with modern medical practice, and so that women, regardless of where they live, have equal access to abortion services”.

To read the full article, visit the Medical Journal of Australia.

Latest news:

Abortion law in Australia: it’s time for national consistency and decriminalisation

Current Australian abortion laws continue to disadvantage many women

It is almost 7 years since abortion was decriminalised in Victoria, where a doctor can now terminate a pregnancy at up to 24 weeks with the woman’s consent, and after 24 weeks with the agreement of a second doctor. This change has not resulted in increased numbers of abortions, which have remained stable over many years.1 Earlier, in 2002, the Australian Capital Territory had removed all criminal sanctions for abortion. Abortion was decriminalised in Tasmania in 2013; here a doctor may perform an abortion at up to 16 weeks with the woman’s consent, and after 16 weeks with the additional agreement of a second doctor. In all remaining Australian jurisdictions, a patchwork of differing abortion laws operate. Only in the ACT has regulation of abortion been removed completely from criminal law.2 These legal inconsistencies have significant ramifications for the access of Australian women to abortion.

Meanwhile, developments move apace in our understanding of fetal health, and in the diagnosis of fetal abnormality. Medicare-funded diagnosis of fetal abnormality is now routinely offered to all pregnant Australian women — with the implication that a woman may choose to terminate the pregnancy if a serious abnormality is detected. The rapid development of non-invasive prenatal testing (NIPT) — a high-level screening approach that analyses cell-free fetal DNA in the maternal bloodstream — will lead to increasing information about the health of the fetus becoming available to women and their partners very early in pregnancy, allowing earlier and safer termination of the pregnancy, should this be their choice.3 Greater awareness of the risks and social costs associated with multiple pregnancies has led to the selective reduction in the number of fetuses carried to term in such pregnancies, in order to maximise the prospects for a healthy birth.4

Abortion laws, however, have not kept pace with these developments.2 Fetal abnormality is specifically discussed in the legislation in Western Australia, South Australia, Tasmania and the Northern Territory, and covered by the decriminalisation of abortion in Victoria and the ACT; in practice, however, late abortion is restricted by health regulations in WA, SA and the NT. In Queensland and New South Wales, the law does not refer to fetal abnormality at all. The result of these differences is continuing and extensive abortion “tourism” from all Australian states to Victoria, and overseas, in the face of barriers to access to abortion.2

Barriers to access

Although mifepristone is being used in accredited hospitals throughout Australia for second trimester abortions on the grounds of fetal abnormality (and many private practitioners and clinics also use it for early medical abortion), access to the drug is very difficult for rural women, especially in SA and the NT, where, by law, abortion can only be performed in designated hospitals.2

Where services are provided, the access of women to these services is often hindered by verbal and sometimes physical harassment outside clinics. Attempts to curtail protesters’ activities have, to date, been unsuccessful, generally because of the protesters’ implied rights to freedom of political communication. To address this problem, Tasmania introduced mandated exclusion zones around clinics in 2013, prohibiting a range of behaviours “in relation to terminations” within 150 metres of an abortion clinic.

The High Court of Australia has provided a two-step test to determine whether the implied right to freedom of political communication has been invalidly curtailed by a particular law. Step one assesses whether the law effectively burdens communication about the federal government or political matters. In those cases where it does, step two requires a determination on whether the law remains valid because it is reasonably appropriate and adapted to serve a legitimate end. Constitutional law scholars generally agree that the Tasmanian provision can withstand any High Court challenge.5

While doctors have the right to conscientious objection to performing an abortion, this objection should not restrict the access of women who consult them to procedures they need. Victorian abortion law reflects this balance, requiring the objecting doctor to refer the woman to a health practitioner who is known to have no conscientious objections to abortion.

Another challenge is the lack of a national data collection of abortion statistics that would assist in ensuring the delivery of appropriate abortion and family planning services, and enable policy makers and law reform agencies to track the effects of changes in law and policy on abortion practice. While statistics are collected in SA, WA and the NT, only the figures for SA are publicly available. This lack of statistics also means that figures for interstate abortion “tourism” are imprecise.

The Victorian review of abortion regulation

The most comprehensive review of abortion regulation was undertaken by the Victorian Law Reform Commission (VLRC) in 2007–2008. The Victorian parliament responded to the VLRC report by not only decriminalising abortion but also by introducing reforms that place the responsibility for decision making with the woman, or the woman and her doctor, and that for service availability with the medical profession; that is, by regulating abortion in the same way as other medical procedures. Together with the inclusion of the Tasmanian anti-harassment provision, the Victorian legislation might be seen as providing a viable model for the rest of Australia.

In 2015, there is an urgent need for legislative uniformity across Australia so that the law is in step with modern medical practice, and so that women, regardless of where they live, have equal access to abortion services.

Signs workforce planning getting back on track

It’s been a chequered time for medical workforce planning in recent years.

Health Workforce Australia (HWA) was a Commonwealth statutory authority established in 2009 to deliver a national and co-ordinated approach to health workforce planning, and had started to make substantial progress toward improving medical workforce planning and coordination. It had delivered two national medical workforce reports and formed the National Medical Training Advisory Network (NMTAN) to enable a nationally coordinated medical training system.

Regrettably, before it could realise its full potential, the Government axed HWA in the 2014-15 Budget, and its functions were moved to the Health Department. This was a short-sighted decision, and it is taking time to rebuild the workforce planning capacity that was lost.

NMTAN is now the Commonwealth’s main medical workforce training advisory body, and is focusing on planning and coordination.

It includes representatives from the main stakeholder groups in medical education, training and employment. Dr Danika Thiemt, Chair of the AMA Council of Doctors in Training, sits with me as the AMA representatives on the network.

Our most recent meeting was late last month, and the discussions there make us hopeful that NMTAN is finally in a position where it can significantly lift its output, contribution and value to medical workforce planning.

In its final report, Australia’s Future Health Workforce, HWA confirmed that Australia has enough medical school places.

Instead, it recommended the focus turn to improving the capacity and distribution of the medical workforce − and encouraging future medical graduates to train in the specialties and locations where they will be needed to meet future community demands for health care.

The AMA supports this approach, but it will require robust modelling.

NMTAN is currently updating HWA modelling on the psychiatry, anaesthetic and general practice workforces. We understand that the psychiatry workforce report will be released soon. This will be an important milestone given what has gone before.

Nonetheless, it will be important to lift the number of specialties modelled significantly now that we have the basic approach in place, so that we will have timely data on imbalances across the full spectrum of specialties.

The AMA Medical Workforce Committee recently considered what NMTAN’s modelling priorities should be for 2016.

Based on its first-hand knowledge of the specialities at risk of workforce shortage and oversupply, the committee identified the following specialty areas as priorities: emergency medicine; intensive care medicine; general medicine; obstetrics and gynaecology; paediatrics; pathology and general surgery.

NMTAN is also developing some factsheets on supply and demand in each of the specialities – some of which now available from the Department of Health’s website (http://www.health.gov.au/internet/main/publishing.nsf/Content/nmtan_subc…). I encourage you to take a look.

These have the potential to give future medical graduates some of the career information they will need to choose a specialty with some assurance that there will be positions for them when they finish their training.

Australia needs to get its medical workforce planning back on track.

Let’s hope that NMTAN and the Department of Health are up to the task.