Margaret Rolfe

A combined phase I and II open label study on the effects of a seaweed extract nutrient complex on osteoarthritis

Background: Isolated fucoidans from brown marine algae have been shown to have a range of anti-inflammatory effects. Purpose: This present study tested a Maritech® extract formulation, containing a blend of extracts from three different species of brown algae, plus nutrients in an open label combined phase I and II pilot scale study to determine both acute safety and efficacy in osteoarthritis of the knee. Patients and methods: Participants (n = 12, five females [mean age, 62 ± 11.06 years] and seven males [mean age, 57.14 ± 9.20 years]) with a confirmed diagnosis of osteoarthritis of the knee were randomized to either 100 mg (n = 5) or 1000 mg (n = 7) of a Maritech® extract formulation per day. The formulation contained Maritech® seaweed extract containing Fucus vesiculosis (85% w/w), Macrocystis pyrifera (10% w/w) and Laminaria japonica (5% w/w) plus vitamin B6, zinc and manganese. Primary outcome was the average comprehensive arthritis test (COAT) score which is comprised of four sub-scales: pain, stiffness, difficulty with physical activity and overall symptom severity measured weekly. Safety measures included full blood count, serum lipids, liver function tests, urea, creatinine and electrolytes determined at baseline and week 12. All adverse events were recorded. Results: Eleven participants completed 12 weeks and one completed 10 weeks of the study. Using a multilevel linear model, the average COAT score was reduced by 18% for the 100 mg treatment and 52% for the 1000 mg dose at the end of the study. There was a clear dose response effect seen between the two treatments (P ≤ 0.0005) on the average COAT score and each of the four COAT subscales (pain, stiffness, difficulty with physical activity and overall symptom severity) (P ≤ 0.05). The preparation was well tolerated and the few adverse events were unlikely to be related to the study medication. There were no changes in blood parameters measured over the course of the study with the exception of an increase in serum albumin which was not clinically significant. Conclusion: The seaweed extract nutrient complex when taken orally over twelve weeks decreased the symptoms of osteoarthritis in a dose-dependent manner. It was demonstrated to be safe to use over the study period at the doses tested. The efficacy of the preparation now needs to be demonstrated in a phase III randomized controlled trial (RCT). Australian and New Zealand Clinical Trials Register: ACTRN12607000229471.

Frequent hospital admission of older people with chronic disease: a cross-sectional survey with telephone follow-up and data linkage

BackgroundThe continued increase in hospital admissions is a significant and complex issue facing health services. There is little research exploring patient perspectives or examining individual admissions among patients with frequent admissions for chronic ambulatory care sensitive (ACS) conditions. This paper aims to describe characteristics of older, rural patients frequently admitted with ACS conditions and identify factors associated with their admissions from the patient perspective.MethodsPatients aged 65+ resident in North Coast NSW with three or more admissions for selected ACS chronic conditions within a 12 month period, were invited to participate in a postal survey and follow up telephone call. Survey and telephone data were linked to admission and health service program data. Descriptive statistics were generated for survey respondents; logistic regression models developed to compare characteristics of patients with 3 or with 4+ admissions; and comparisons made between survey respondents and non-respondents.ResultsSurvey respondents (n=102) had a mean age of 77.1 years (range 66–95 years), and a mean of 4.1 admissions within 12 months; 49% had at least three chronic conditions; the majority had low socioeconomic status; one in five (22%) reported some difficulty affording their medication; and 35% lived alone. The majority reported psychological distress with 31% having moderate or severe psychological distress. While all had a GP, only 38% reported having a written GP care plan. 22% of those who needed regular help with daily tasks did not have a close friend or relative who regularly cared for them. Factors independently associated with more frequent (n=4+) relative to less frequent (n=3) admissions included having congestive heart failure (p=0.003), higher social isolation scores (p=0.040) and higher Charlson Comorbidity Index scores (p=0.049). Most respondents (61%) felt there was nothing that could have avoided their most recent admission, although some potential avoidability of admission was described around medication and health behaviours. Respondents were younger and less sick than non-respondents.ConclusionsThis study provides a detailed description of older patients with multiple chronic conditions and a history of frequent admission in rural Australia. Our results suggest that programs targeting medication use, health behaviours and social isolation may help reduce multiple hospital admissions for chronic disease.

A combined Phase I and II open-label study on the immunomodulatory effects of seaweed extract nutrient complex

Background: Isolated fucoidans from brown marine algae have been shown to have a range of immune-modulating effects. This exploratory study aimed to determine whether a seaweed nutrient complex containing a blend of extracts from three different species of brown algae plus nutrients is safe to administer and has biological potential as an immune modulator. The study was undertaken as an open-label combined Phase I and II study. Methods: Participants (n = 10) were randomized to receive the study medication at either a 100 mg (n = 5) or 1000 mg (n = 5) dose over 4 weeks. The primary outcome measurement was in vivo changes in lymphocyte subsets. The secondary outcome measures were ex vivo changes in T-lymphocyte (CD4 and CD8) activation, phagocytosis of granulocytes and monocytes, T helper 1/T helper 2 cytokines, and serum oxygen radical absorbance capacity. Results: The preparation was found to be safe over the 4 weeks at both doses tested. There were no clinically relevant changes to blood measurements of hemopoietic, hepatic, or renal function. Immunomodulatory measurements showed no dose response between the two doses. The combined results from the two doses demonstrated a significant increase in cytotoxic T cell numbers and phagocytic capacity in monocytes, and a significant decrease in levels of the inflammatory cytokine interleukin 6. A separate analysis of the 100 mg dose (n = 5) alone showed a significant linear component over time (P < 0.05) for phagocytosis by both granulocytes and monocytes. Conclusion: The seaweed nutrient complex was safe to use when taken orally over 4 weeks. The preparation was demonstrated to have potential as an immune modulator, and this bioactivity deserves further exploration.

Retention of the rural allied health workforce in New South Wales: a comparison of public and private practitioners

BackgroundPolicy initiatives to improve retention of the rural health workforce have relied primarily on evidence for rural doctors, most of whom practice under a private business model. Much of the literature for rural allied health (AH) workforce focuses on the public sector. The AH professions are diverse, with mixed public, private or combined practice settings. This study explores sector differences in factors affecting retention of rural AH professionals.MethodsThis study compared respondents from the 2008 Rural Allied Health Workforce (RAHW) survey recruiting all AH professionals in rural New South Wales. Comparisons between public (n = 833) and private (n = 756) groups were undertaken using Chi square analysis to measure association for demographics, job satisfaction and intention to leave. The final section of the RAHW survey comprised 33 questions relating to retention. A factor analysis was conducted for each cohort. Factor reliability was assessed and retained factors were included in a binary logistic regression analysis for each cohort predicting intention to leave.ResultsSix factors were identified: professional isolation, participation in community, clinical demand, taking time away from work, resources and ‘specialist generalist’ work. Factors differed slightly between groups. A seventh factor (management) was present only in the public cohort. Gender was not a significant predictor of intention to leave. Age group was the strongest predictor of intention to leave with younger and older groups being significantly more likely to leave than middle aged.In univariate logistic analysis (after adjusting for age group), the ability to get away from work did not predict intention to leave in either group. In multivariate analysis, high clinical demand predicted intention to leave in both the public (OR = 1.40, 95% CI = 1.08, 1.83) and private (OR = 1.61, 95% CI = 1.15, 2.25) cohorts. Professional isolation (OR = 1.39. 95% CI = 1.11, 1.75) and Participation in community (OR = 1.57, 95% CI = 1.13, 2.19) also contributed to the model in the public cohort.ConclusionsThis paper demonstrates differences between those working in public versus private sectors and suggests that effectiveness of policy initiatives may be improved through better targeting.

Babies born before arrival to hospital and maternity unit closures in Queensland and Australia

BACKGROUND Evidence suggests the closure of maternity units is associated with an increase in babies born before arrival (BBA). AIM To explore the association between the number of maternity units in Australia and Queensland by birthing numbers, BBA rate and geographic remoteness of the health district where the mother lives. METHODS A retrospective study utilised routinely collected perinatal data (1992-2011). Pearson correlation tested the relationship between BBA rate and number of maternity units. Linear regression examined this association over time. FINDINGS During 1992-2011, the absolute numbers (N=22,814) of women having a BBA each year in Australia increased by 47% (N=836-1233); and 206% (n=140-429) in Queensland. This coincided with a 41% reduction in maternity units in Australia (N=623-368=18 per year) and a 28% reduction in Queensland (n=129-93). BBA rates increased significantly across Australia, r=0.837, n=20 years, p<0.001 and Queensland, r=0.917, n=20 years, p<0.001 and this was negatively correlated with the number of maternity units in Australia, r=-0.804, n=19 years, p<0.001 and Queensland, r=-0.906, n=19 years, p<0.001. CONCLUSIONS The closure of maternity units over a 20-year period across Australia and Queensland is significantly associated with increased BBA rates. The distribution is not limited to rural and remote areas. Given the high risk of adverse maternal and neonatal outcomes associated with BBA, it is time to revisit the closure of units.

Perceptions of risk from nanotechnologies and trust in stakeholders: a cross sectional study of public, academic, government and business attitudes

BackgroundPolicy makers and regulators are constantly required to make decisions despite the existence of substantial uncertainty regarding the outcomes of their proposed decisions. Understanding stakeholder views is an essential part of addressing this uncertainty, which provides insight into the possible social reactions and tolerance of unpredictable risks. In the field of nanotechnology, large uncertainties exist regarding the real and perceived risks this technology may have on society. Better evidence is needed to confront this issue.MethodsWe undertook a computer assisted telephone interviewing (CATI) survey of the Australian public and a parallel survey of those involved in nanotechnology from the academic, business and government sectors. Analysis included comparisons of proportions and logistic regression techniques. We explored perceptions of nanotechnology risks both to health and in a range of products. We examined views on four trust actors.ResultsThe general public’s perception of risk was significantly higher than that expressed by other stakeholders. The public bestows less trust in certain trust actors than do academics or government officers, giving its greatest trust to scientists. Higher levels of public trust were generally associated with lower perceptions of risk. Nanotechnology in food and cosmetics/sunscreens were considered riskier applications irrespective of stakeholder, while familiarity with nanotechnology was associated with a reduced risk perception.ConclusionsPolicy makers should consider the disparities in risk and trust perceptions between the public and influential stakeholders, placing greater emphasis on risk communication and the uncertainties of risk assessment in these areas of higher concern. Scientists being the highest trusted group are well placed to communicate the risks of nanotechnologies to the public.

Cognitive effects of chemotherapy-induced menopause in breast cancer

This study examined whether chemotherapy-induced menopause affects cognitive functioning in women with early breast cancer. The neuropsychological performance of 121 breast cancer patients (age M = 49.62, SD = 8.11, range = 25.25–67.92) treated with chemotherapy was assessed pre-chemotherapy, as well as 1, 6, and 18 months post-chemotherapy completion. Linear mixed modeling was used to evaluate the data. Type of menopause (pre, chemotherapy-induced, and post menopause) was found to significantly interact with cognitive performance on two cognitive variables. Specifically, chemotherapy-induced menopausal women did not show any significant changes in performance on an abstract reasoning task, while the pre-menopausal and post-menopausal groups significantly improved over time. A significant interaction on a test of finger dexterity and coordination was also found, although inspection of the results indicated that this was due to a significant improvement in the pre-menopausal groups at 6 months post chemotherapy. After chemotherapy most cognitive variables showed improvements over time, although two indicators of verbal memory showed significant declines immediately after chemotherapy, with improvement by 18 months post completion. The current study found little evidence to suggest that chemotherapy-induced menopause broadly affects cognitive functioning after treatment administration. However, longer follow-up assessments are warranted to assess the long-term effects of combined chemotherapy and endocrine treatment.

Remote links: Redesigning maternity care for Aboriginal women from remote communities in Northern Australia – A comparative cohort study

OBJECTIVE to compare the quality of care before and after the introduction of the new Midwifery Group Practice. DESIGN a cohort study. SETTING the health centers (HCs) in two of the largest remote Aboriginal communities (population 2200-2600) in the Top End of the Northern Territory (NT), each located approximately 500km from Darwin. The third study site was the Royal Darwin Hospital (RDH) which provides tertiary care. METHODS a 2004-06 retrospective cohort (n=412 maternity cases) provided baseline data. A clinical redesign of maternity services occurring from 2009 onwards focused on increasing Continuity of Carer, Communication, Choice, Collaboration and Co-ordination of Care (5Cs). Data from a 2009-11 prospective cohort (n=310 maternity cases) were collected to evaluate the service redesign. Outcome measures included indicators on the quality of care delivery, adherence to recommended antenatal guidelines and maternal and neonatal health outcomes. FINDINGS statistically significant improvements were recorded in many areas reflecting improved access to, and quality of, care. For example: fewer women had <4 visits in pregnancy (14% versus 8%), a higher proportion of women had routine antenatal tests recorded (86% versus 97%) and improved screening rates for urine (82% versus 87%) and sexual tract infections (78% versus 93%). However, the treatment of conditions according to recommended guidelines worsened significantly in some areas; for example antibiotics prescribed for urine infections (86% versus 52%) and treatment for anaemia in pregnancy (77% versus 67%). High preterm (21% versus 20%), low birth weight (18% versus 20%) and PPH (29% versus 31%) rates did not change over time. The out of hospital birth rate remained high and unchanged in both cohorts (10% versus 10%). CONCLUSION this model addresses some of the disparities in care for remote-dwelling Aboriginal women. However, much work still needs to occur before maternity care and outcomes are equal to that of non-Aboriginal women. Targeted program interventions with stronger clinical governance frameworks to improve the quality of care are essential. A complete rethink of service delivery and engagement may deliver better results.

Reconceptualising risk: Perceptions of risk in rural and remote maternity service planning

OBJECTIVE to explore perceptions and examples of risk related to pregnancy and childbirth in rural and remote Australia and how these influence the planning of maternity services. DESIGN data collection in this qualitative component of a mixed methods study included 88 semi-structured individual and group interviews (n=102), three focus groups (n=22) and one group information session (n=17). Researchers identified two categories of risk for exploration: health services risk (including clinical and corporate risks) and social risk (including cultural, emotional and financial risks). Data were aggregated and thematically analysed to identify perceptions and examples of risk related to each category. SETTING fieldwork was conducted in four jurisdictions at nine sites in rural (n=3) and remote (n=6) Australia. PARTICIPANTS 117 health service employees and 24 consumers. MEASUREMENTS AND FINDINGS examples and perceptions relating to each category of risk were identified from the data. Most medical practitioners and health service managers perceived clinical risks related to rural birthing services without access to caesarean section. Consumer participants were more likely to emphasise social risks arising from a lack of local birthing services. KEY CONCLUSIONS our analysis demonstrated that the closure of services adds social risk, which exacerbates clinical risk. Analysis also highlighted that perceptions of clinical risk are privileged over social risk in decisions about rural and remote maternity service planning. IMPLICATIONS FOR PRACTICE a comprehensive analysis of risk that identifies how social and other forms of risk contribute to adverse clinical outcomes would benefit rural and remote people and their health services. Formal risk analyses should consider the risks associated with failure to provide birthing services in rural and remote communities as well as the risks of maintaining services.

Diagnosing Potentially Preventable Hospitalisations (DaPPHne): protocol for a mixed-methods data-linkage study

Introduction Rates of potentially preventable hospitalisations (PPH) are used as a proxy measure of effectiveness of, or access to community-based health services. The validity of PPH as an indicator in Australia has not been confirmed. Available evidence suggests that patient-related, clinician-related and systems-related factors are associated with PPH, with differences between rural and metropolitan settings. Furthermore, the proportion of PPHs which are actually preventable is unknown. The Diagnosing Potentially Preventable Hospitalisations study will determine the proportion of PPHs for chronic conditions that are deemed preventable and identify potentially modifiable factors driving these, in order to develop effective interventions to reduce admissions and improve measures of health system performance. Methods and analysis This mixed methods data linkage study of approximately 1000 eligible patients with chronic PPH admissions to one metropolitan and two regional hospitals over 12 months will combine data from multiple sources to assess the: extent of preventability of chronic PPH admissions; validity of the Preventability Assessment Tool (PAT) in identifying preventable admissions; factors contributing to chronic PPH admissions. Data collected from patients (quantitative and qualitative methods), their general practitioners, hospital clinicians and hospital records, will be linked with routinely collected New South Wales (NSW) Admitted Patient Data Collection, the NSW Registry of Births, Death and Marriages death registration and Australian Bureau of Statistics mortality data. The validity of the PAT will be assessed by determining concordance between clinician assessment and that of a ‘gold standard’ panel. Multivariable logistic regression will identify the main predictor variables of admissions deemed preventable, using study-specific and linked data. Ethics and dissemination The NSW Population and Health Services Research Ethics Committee granted ethical approval. Dissemination mechanisms include engagement of policy stakeholders through a project Steering Committee, and the production of summary reports for policy and clinical audiences in addition to peer-review papers.