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1.  Under-reporting of socioeconomic status of patients in stroke trials: adherence to CONSORT principles 
Background and Purpose
The 2001 Revised CONSORT statement requires reporting of RCTs to include participants’ baseline demographics. This enables comparison of intervention and control groups on potential confounding variables as well as assessment of study generalizability. Socioeconomic status (SES) is associated with access to care and outcomes (mortality, functional outcome, recurrent stroke, and hospital readmission) post-stroke. We aimed to document the reporting of baseline SES in reports of RCTs of stroke and TIA.
Methods
Measures of SES were extracted from papers reporting trials of stroke or TIA published in twelve major journals (General Medicine, General Neurology, Cerebrovascular Disease, or Rehabilitation) subsequent to revised-CONSORT. Percentages of papers reporting SES measures were calculated. Differences in reporting between journal categories, and temporal trends in reporting, were tested.
Results
12% of papers reported any SES measure. Journal categories did not differ in rate of SES reporting. SES reporting didn’t increase over time.
Conclusions
Improving reporting of SES could enhance clinicians’ ability to evaluate RCT findings and apply them to their patients.
doi:10.1161/STROKEAHA.113.002414
PMCID: PMC4273080  PMID: 23899911
Stroke; Socioeconomic factors; Randomized Controlled Trials; Ischemic Attack; Transient
2.  Improving chlamydia knowledge should lead to increased chlamydia testing among Australian general practitioners: a cross-sectional study of chlamydia testing uptake in general practice 
BMC Infectious Diseases  2014;14(1):584.
Background
Female general practitioners (GPs) have higher chlamydia testing rates than male GPs, yet it is unclear whether this is due to lack of knowledge among male GPs or because female GPs consult and test more female patients.
Methods
GPs completed a survey about their demographic details and knowledge about genital chlamydia. Chlamydia testing and consultation data for patients aged 16-29 years were extracted from the medical records software for each GP and linked to their survey responses. Chi-square tests were used to determine differences in a GP’s knowledge and demographics. Two multivariable models that adjusted for the gender of the patient were used to investigate associations between a GP and their chlamydia testing rates ― Model 1 included GPs’ characteristics such as age and gender, Model 2 excluded these characteristics to specifically examine any associations with knowledge.
Results
Female GPs were more likely than male GPs to know when to re-test a patient after a negative chlamydia test (18.8% versus 9.7%, p = 0.01), the correct symptoms suggestive of PID (80.5% versus 67.8%, p = 0.01) and the correct tests for diagnosing PID (57.1% versus 42.6%, p = 0.01). Female GPs tested 6.5% of patients, while male GPs tested 2.2% (p < 0.01). Model 1 found factors associated with chlamydia testing were being a female GP (OR = 2.5, 95% CI: 1.9, 3.3) and working in a metropolitan clinic (OR = 3.2; 95% CI: 2.4, 4.3). Model 2 showed that chlamydia testing increased as knowledge of testing guidelines improved (3-5 correct answers – AOR = 2.0, 95% CI: 1.0, 4.2; 6+ correct answers – AOR = 2.9, 95% CI: 1.4, 6.2).
Conclusions
Higher rates of chlamydia testing are strongly associated with GPs who are female, based in a metropolitan clinic and among those with more knowledge of the recommended guidelines. Improving chlamydia knowledge among male GPs may increase chlamydia testing.
doi:10.1186/s12879-014-0584-2
PMCID: PMC4228271  PMID: 25409698
Chlamydia testing; General practice; Sexual health knowledge; General practitioner education
3.  Decreased Management of Genital Warts in Young Women in Australian General Practice Post Introduction of National HPV Vaccination Program: Results from a Nationally Representative Cross-Sectional General Practice Study 
PLoS ONE  2014;9(9):e105967.
Objectives
Since the introduction of Australia's human papillomavirus vaccination program, the management rate of genital warts in sexual health clinics and private hospitals has decreased in women of vaccine-eligible age. However, most genital warts in Australia are managed in general practice. This study examines whether a similar decrease occurred in Australian general practice after the introduction of the program.
Methods
Analysis of a nationally representative cross-sectional database of Australian general practice activity (1,175,879 patient encounters with 11,780 general practitioners). Genital warts management rates were estimated for the periods before and after introduction of the program (Pre-program, July 2002-June 2006; Post-program, July 2008-June 2012). Control conditions included genital herpes and gardnerella/bacterial vaginosis in female patients and genital herpes and urethritis in male patients. Trends in management rates by year, pre-vaccine (July 2000-June 2007) and post-vaccine (July 2007-June 2012) were also calculated.
Results
Management rate of genital warts among women potentially covered by program (aged 15–27 years) decreased by 61% from 4.33 per 1,000 encounters in the Pre-program period to 1.67 in the Post-program period. Trend analysis of the post-vaccine period showed, among women of vaccine eligible age, a significant year-on-year reduction in the rate of genital warts management (p<0.0001) and a significant increase in the management rate of control conditions per year (p<0.0001). For all other age-sex groups there was no significant change in the management rate of genital warts between the Pre- and Post-program periods.
Conclusion
The large decrease in general practice management of genital warts in women of vaccine-eligible age highlights the success of the program in the wider community.
doi:10.1371/journal.pone.0105967
PMCID: PMC4152193  PMID: 25180698
4.  St John’s wort use in Australian general practice patients with depressive symptoms: their characteristics and use of other health services 
Background
While depression is frequently managed by general practitioners, often patients self-manage these symptoms with alternative therapies, including St John’s wort (SJW). We tested whether use of SJW was associated with different patterns of conventional and complementary health service use, strategies used for management of depression, or user dissatisfaction with or lack of trust in their general practitioner or clinic overall.
Methods
Secondary analysis of data collected from an Australian population screened for a longitudinal cohort study of depression. Main outcome measures were CES-D for depressive symptoms, satisfaction with their general practitioner (GPAQ), Trust in Physician scale, self-report of health services usage and strategies used to manage depression, stress or worries.
Results
Response rate was 7667/17,780 (43.1%). Of these, 4.3% (320/7,432) had used SJW in the past 12 months (recent ‘SJW users’). SJW users were significantly more likely to be depressed and to have a higher CES-D score. There were no statistically significant differences between recent SJW users and non-SJW users in satisfaction with their general practice or in trust in their general practitioner (GP) when adjusted for multiple factors. SJW users were significantly more likely to use all health services, whether conventional or complementary, as well as other strategies used for mental health care. SJW users were also more likely to consider themselves the main carer for their depression.
Conclusions
Primary care attendees with symptoms of depression who use SJW appear not to be rejecting conventional medicine. Rather, they may be proactive care seekers who try both conventional and complementary strategies to manage their depressive symptoms. If GPs enquire and find that their depressed patients are using SJW, this may indicate that they might explore for unrelieved symptoms of depression and also consider the issue of potential for interactions between SJW and other medicines.
doi:10.1186/1472-6882-14-204
PMCID: PMC4082422  PMID: 24969102
St John’s wort; Hypericum perforatum; Depression; General practice; Complementary therapies; Patient care
5.  Development of a survey instrument to investigate the primary care factors related to differences in cancer diagnosis between international jurisdictions 
BMC Family Practice  2014;15:122.
Background
Survival rates following a diagnosis of cancer vary between countries. The International Cancer Benchmarking Partnership (ICBP), a collaboration between six countries with primary care led health services, was set up in 2009 to investigate the causes of these differences. Module 3 of this collaboration hypothesised that an association exists between the readiness of primary care physicians (PCP) to investigate for cancer – the ‘threshold’ risk level at which they investigate or refer to a specialist for consideration of possible cancer – and survival for that cancer (lung, colorectal and ovarian). We describe the development of an international survey instrument to test this hypothesis.
Methods
The work was led by an academic steering group in England. They agreed that an online survey was the most pragmatic way of identifying differences between the jurisdictions. Research questions were identified through clinical experience and expert knowledge of the relevant literature.
A survey comprising a set of direct questions and five clinical scenarios was developed to investigate the hypothesis. The survey content was discussed and refined concurrently and repeatedly with international partners. The survey was validated using an iterative process in England. Following validation the survey was adapted to be relevant to the health systems operating in other jurisdictions and translated into Danish, Norwegian and Swedish, and into Canadian and Australian English.
Results
This work has produced a survey with face, content and cross cultural validity that will be circulated in all six countries. It could also form a benchmark for similar surveys in countries with similar health care systems.
Conclusions
The vignettes could also be used as educational resources. This study is likely to impact on healthcare policy and practice in participating countries.
doi:10.1186/1471-2296-15-122
PMCID: PMC4073814  PMID: 24938306
Survey; Primary care; Cancer; Diagnosis; International
6.  Acupuncture for menopausal vasomotor symptoms: study protocol for a randomised controlled trial 
Trials  2014;15:224.
Background
Hot flushes and night sweats (vasomotor symptoms) are common menopausal symptoms, often causing distress, sleep deprivation and reduced quality of life. Although hormone replacement therapy is an effective treatment, there are concerns about serious adverse events. Non-hormonal pharmacological therapies are less effective and can also cause adverse effects. Complementary therapies, including acupuncture, are commonly used for menopausal vasomotor symptoms. While the evidence for the effectiveness of acupuncture in treating vasomotor symptoms is inconclusive, acupuncture has a low risk of adverse effects, and two small studies suggest it may be more effective than non-insertive sham acupuncture. Our objective is to assess the efficacy of needle acupuncture in improving hot flush severity and frequency in menopausal women. Our current study design is informed by methods tested in a pilot study.
Methods/design
This is a stratified, parallel, randomised sham-controlled trial with equal allocation of participants to two trial groups. We are recruiting 360 menopausal women experiencing a minimum average of seven moderate hot flushes a day over a seven-day period and who meet diagnostic criteria for the Traditional Chinese Medicine diagnosis of Kidney Yin deficiency. Exclusion criteria include breast cancer, surgical menopause, and current hormone replacement therapy use. Eligible women are randomised to receive either true needle acupuncture or sham acupuncture with non-insertive (blunt) needles for ten treatments over eight weeks. Participants are blinded to treatment allocation. Interventions are provided by Chinese medicine acupuncturists who have received specific training on trial procedures. The primary outcome measure is hot flush score, assessed using the validated Hot Flush Diary. Secondary outcome measures include health-related quality of life, anxiety and depression symptoms, credibility of the sham treatment, expectancy and beliefs about acupuncture, and adverse events. Participants will be analysed in the groups in which they were randomised using an intention-to-treat analysis strategy.
Discussion
Results from this trial will significantly add to the current body of evidence on the role of acupuncture for vasomotor symptoms. If found to be effective and safe, acupuncture will be a valuable additional treatment option for women who experience menopausal vasomotor symptoms.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12611000393954 11/02/2009.
doi:10.1186/1745-6215-15-224
PMCID: PMC4066294  PMID: 24925094
Acupuncture; Complementary medicine; Menopause; Hot flashes; Vasomotor symptoms; Quality of life; Placebo
7.  Protocol for the ProCare Trial: a phase II randomised controlled trial of shared care for follow-up of men with prostate cancer 
BMJ Open  2014;4(3):e004972.
Introduction
Men with prostate cancer require long-term follow-up to monitor disease progression and manage common adverse physical and psychosocial consequences of treatment. There is growing recognition of the potential role of primary care in cancer follow-up. This paper describes the protocol for a phase II multisite randomised controlled trial of a novel model of shared care for the follow-up of men after completing treatment for low-moderate risk prostate cancer.
Methods and analysis
The intervention is a shared care model of follow-up visits in the first 12 months after completing treatment for prostate cancer with the following specific components: a survivorship care plan, general practitioner (GP) management guidelines, register and recall systems, screening for distress and unmet needs and patient information resources. Eligible men will have completed surgery and/or radiotherapy for low-moderate risk prostate cancer within the previous 8 weeks and have a GP who consents to participate. Ninety men will be randomised to the intervention or current hospital follow-up care. Study outcome measures will be collected at baseline, 3, 6 and 12 months and include anxiety, depression, unmet needs, prostate cancer-specific quality of life and satisfaction with care. Clinical processes and healthcare resource usage will also be measured. The principal emphasis of the analysis will be on obtaining estimates of the treatment effect size and assessing feasibility in order to inform the design of a subsequent phase III trial.
Ethics and dissemination
Ethics approval has been granted by the University of Western Australia and from all hospital recruitment sites in Western Australia and Victoria.
Results
of this phase II trial will be reported in peer-reviewed publications and in conference presentations.
Trial Registration
Australian New Zealand Clinical Trial Registry ACTRN12610000938000
doi:10.1136/bmjopen-2014-004972
PMCID: PMC3948582  PMID: 24604487
Primary Care
8.  Rapid assay to assess colonization patterns following in-vivo probiotic ingestion 
BMC Research Notes  2013;6:252.
Background
Colonization of the intestine with some microorganisms has been shown to have beneficial health effects. The association of bacteria with its human host starts soon after birth; however in infants born prematurely establishment of normal intestinal flora is interrupted with colonization with potential pathogenic organisms Probiotic supplementation may therefore be beneficial to the health of preterm infants. As most probiotic organisms are difficult to culture, confirmation of their colonization after supplementation is difficult. In this study, rapid qPCR assays for detection of presence of probiotic species in the intestine by faecal sampling is described in both preterm infant and adult participants.
Findings
Probiotic colonization was determined using qPCR directed at amplification of organisms present in the ingested probiotic Streptococcus thermophilus, Bifidobacterium animalis subsp. lactis and B. longum subsp. infantis. Overall, differential detection of probiotic strains in faeces were found between adult and preterm infants, with 50% of infants continuing to shed at least two probiotic strains three weeks after probiotic ingestion had ceased.
Conclusions
This study demonstrated rapid assessment of the preterm infant gut for colonization with probiotic strains using real-time PCR. This method would be of great importance in studies of probiotics in prevention of diseases and adverse clinical outcomes.
doi:10.1186/1756-0500-6-252
PMCID: PMC3711785  PMID: 23830222
Probiotics; qPCR; Preterm infant; Micro biome
9.  Prevalent and Incident Bacterial Vaginosis Are Associated with Sexual and Contraceptive Behaviours in Young Australian Women 
PLoS ONE  2013;8(3):e57688.
Background
To determine prevalence and incidence of bacterial vaginosis (BV) and risk factors in young sexually-active Australian women.
Methods
1093 women aged 16–25 years were recruited from primary-care clinics. Participants completed 3-monthly questionnaires and self-collected vaginal smears 6-monthly for 12-months. The primary endpoint was a Nugent Score = 7–10 (BV) and the secondary endpoint was a NS = 4–10 (abnormal flora [AF]). BV and AF prevalence estimates and 95% confidence intervals (95%CI) were derived, and adjusted odds ratios (AOR) calculated to explore epidemiological associations with prevalent BV and AF. Proportional-hazards regression models were used to examine factors associated with incident BV and AF.
Results
At baseline 129 women had BV [11.8% (95%CI: 9.4–14.2)] and 188 AF (17.2%; 15.1–19.5). Prevalent BV was associated with having a recent female partner [AOR = 2.1; 1.0–4.4] and lack of tertiary-education [AOR = 1.9; 1.2–3.0]; use of an oestrogen-containing contraceptive (OCC) was associated with reduced risk [AOR = 0.6; 0.4–0.9]. Prevalent AF was associated with the same factors, and additionally with >5 male partners (MSP) in 12-months [AOR = 1.8; 1.2–2.5)], and detection of C.trachomatis or M.genitalium [AOR = 2.1; 1.0–4.5]. There were 82 cases of incident BV (9.4%;7.7–11.7/100 person-years) and 129 with incident AF (14.8%; 12.5–17.6/100 person-years). Incident BV and AF were associated with a new MSP [adjusted rate ratio (ARR) = 1.5; 1.1–2.2 and ARR = 1.5; 1.1–2.0], respectively. OCC-use was associated with reduced risk of incident AF [ARR = 0.7; 0.5–1.0].
Conclusion
This paper presents BV and AF prevalence and incidence estimates from a large prospective cohort of young Australian women predominantly recruited from primary-care clinics. These data support the concept that sexual activity is strongly associated with the development of BV and AF and that use of an OCC is associated with reduced risk.
doi:10.1371/journal.pone.0057688
PMCID: PMC3589386  PMID: 23472099
10.  Efficacy of acupuncture for chronic knee pain: protocol for a randomised controlled trial using a Zelen design 
Background
Chronic knee pain is a common and disabling condition in people over 50 years of age, with knee joint osteoarthritis being a major cause. Acupuncture is a popular form of complementary and alternative medicine for treating pain and dysfunction associated with musculoskeletal conditions. This pragmatic Zelen-design randomised controlled trial is investigating the efficacy and cost-effectiveness of needle and laser acupuncture, administered by medical practitioners, in people with chronic knee pain.
Methods/Design
Two hundred and eighty two people aged over 50 years with chronic knee pain have been recruited from metropolitan Melbourne and regional Victoria, Australia. Participants originally consented to participate in a longitudinal natural history study but were then covertly randomised into one of four treatment groups. One group continued as originally consented (ie natural history group) and received no acupuncture treatment. The other three were treatment groups: i) laser acupuncture, ii) sham laser or, iii) needle acupuncture. Acupuncture treatments used a combined Western and Traditional Chinese Medicine style, were delivered by general practitioners and comprised 8–12 visits over 12 weeks. Follow-up is currently ongoing. The primary outcomes are pain measured by an 11-point numeric rating scale (NRS) and self-reported physical function measured by the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index subscale at the completion of treatment at 12 weeks. Secondary outcomes include quality of life, global rating of change scores and additional measures of pain (other NRS and WOMAC subscale) and physical function (NRS). Additional parameters include a range of psychosocial measures in order to evaluate potential relationships with acupuncture treatment outcomes. Relative cost-effectiveness will be determined from health service usage and outcome data. Follow-up assessments will also occur at 12 months.
Discussion
The findings from this study will help determine whether laser and/or needle acupuncture is efficacious, and cost-effective, in the management of chronic knee pain in older people.
Trial registration
Australian New Zealand Clinical Trials Registry reference: ACTRN12609001001280
doi:10.1186/1472-6882-12-161
PMCID: PMC3493360  PMID: 22992309
11.  Chlamydia trachomatis Incidence and Re-Infection among Young Women – Behavioural and Microbiological Characteristics 
PLoS ONE  2012;7(5):e37778.
Background
This study aimed to estimate rates of chlamydia incidence and re-infection and to investigate the dynamics of chlamydia organism load in prevalent, incident and re-infections among young Australian women.
Methods
1,116 women aged 16 to 25 years were recruited from primary care clinics in Australia. Vaginal swabs were collected at 3 to 6 month intervals for chlamydia testing. Chlamydia organism load was measured by quantitative PCR.
Results
There were 47 incident cases of chlamydia diagnosed and 1,056.34 person years of follow up with a rate of 4.4 per 100 person years (95% CI: 3.3, 5.9). Incident infection was associated with being aged 16 to 20 years [RR = 3.7 (95%CI: 1.9, 7.1)], being employed [RR = 2.4 (95%CI: 1.1, 4.9)] and having two or more new sex partners [RR = 5.5 (95%CI: 2.6, 11.7)]. Recent antibiotic use was associated with a reduced incidence [RR:0.1 (95%CI: 0.0, 0.5)]. There were 14 re-infections with a rate of 22.3 per 100 person years (95%CI: 13.2, 37.6). The median time to re-infection was 4.6 months. Organism load was higher for prevalent than incident infections (p<0.01) and for prevalent than re-infections (p<0.01).
Conclusions
Chlamydia is common among young women and a high proportion of women are re-infected within a short period of time, highlighting the need for effective partner treatment and repeat testing. The difference in organism load between prevalent and incident infections suggests prevalent infection may be more important for ongoing transmission of chlamydia.
doi:10.1371/journal.pone.0037778
PMCID: PMC3360595  PMID: 22662220
12.  Efficacy of Oral Metronidazole with Vaginal Clindamycin or Vaginal Probiotic for Bacterial Vaginosis: Randomised Placebo-Controlled Double-Blind Trial 
PLoS ONE  2012;7(4):e34540.
Background
To determine if oral metronidazole (MTZ-400mg bid) with 2% vaginal clindamycin-cream (Clind) or a Lactobacillus acidophilus vaginal-probiotic containing oestriol (Prob) reduces 6-month bacterial vaginosis (BV) recurrence.
Methods
Double-blind placebo-controlled parallel-group single-site study with balanced randomization (1∶1∶1) conducted at Melbourne Sexual Health Centre, Australia. Participants with symptomatic BV [Nugent Score (NS) = 7–10 or ≥3 Amsel's criteria and NS = 4–10], were randomly allocated to MTZ-Clind, MTZ-Prob or MTZ-Placebo and assessed at 1,2,3 and 6 months. MTZ and Clind were administered for 7 days and Prob and Placebo for 12 days. Primary outcome was BV recurrence (NS of 7–10) on self-collected vaginal-swabs over 6-months. Cumulative BV recurrence rates were compared between groups by Chi-squared statistics. Kaplan-Meier, log rank and Cox regression analyses were used to compare time until and risk of BV recurrence between groups.
Results
450 18–50 year old females were randomized and 408 (91%), equally distributed between groups, provided ≥1 NS post-randomization and were included in analyses; 42 (9%) participants with no post-randomization data were excluded. Six-month retention rates were 78% (n = 351). One-month BV recurrence (NS 7–10) rates were 3.6% (5/140), 6.8% (9/133) and 9.6% (13/135) in the MTZ-Clind, MTZ-Prob and MTZ-Placebo groups respectively, p = 0.13. Hazard ratios (HR) for BV recurrence at one-month, adjusted for adherence to vaginal therapy, were 0.43 (95%CI 0.15–1.22) and 0.75 (95% CI 0.32–1.76) in the MTZ-Clind and MTZ-Prob groups compared to MTZ-Plac respectively. Cumulative 6-month BV recurrence was 28.2%; (95%CI 24.0–32.7%) with no difference between groups, p = 0.82; HRs for 6-month BV recurrence for MTZ-Clind and MTZ-Prob compared to MTZ-Plac, adjusted for adherence to vaginal therapy were 1.09(95% CI = 0.70–1.70) and 1.03(95% CI = 0.65–1.63), respectively. No serious adverse events occurred.
Conclusion
Combining the recommended first line therapies of oral metronidazole and vaginal clindamycin, or oral metronidazole with an extended-course of a commercially available vaginal-L.acidophilus probiotic, does not reduce BV recurrence.
Trial Registration
ANZCTR.org.au ACTRN12607000350426
doi:10.1371/journal.pone.0034540
PMCID: PMC3317998  PMID: 22509319
13.  Participant demographics reported in "Table 1" of randomised controlled trials: a case of "inverse evidence"? 
Introduction
Data supporting external validity of trial results allows clinicians to assess the applicability of a study's findings to their practice population. Socio-economic status (SES) of trial participants may be critical to external validity given the relationship between social and economic circumstances and health. We explored how this is documented in reports of RCTs in four major general medical journals.
Methods
The contents lists of four leading general medical journals were hand searched to identify 25 consecutive papers reporting RCT results in each journal (n = 100). Data on demographic characteristics were extracted from each paper's Table 1 only (or equivalent).
Results
Authors infrequently reported key demographic characteristics relating to SES of RCT participants. Age and gender of participants were commonly reported. Less than 10% reported occupational group, employment status, income or area based measures of disadvantage.
Conclusions
Without adequate reporting of key indicators of SES in trial participants it is unclear if lower SES groups are under-represented. If such groups are systematically under-recruited into trials, this may limit the external validity and applicability of study findings to these groups. This is in spite of the higher health-care need in more disadvantaged populations. Under-representation of low SES groups could underestimate the reported effect of an intervention for those with a higher baseline risk. The marginal benefit identified in a trial with poor or no representation of lower SES participants could significantly underestimate the potential benefit to a low SES community. More transparency in this reporting and greater attention to the impact of SES on intervention outcomes in clinical trials is needed. This could be considered in the next revision of the CONSORT statement.
doi:10.1186/1475-9276-11-14
PMCID: PMC3379950  PMID: 22429574
14.  A comparison of complementary and alternative medicine users and use across geographical areas: A national survey of 1,427 women 
Background
Evidence indicates that people who reside in non-urban areas have a higher use of complementary and alternative medicine (CAM) than people who reside in urban areas. However, there is sparse research on the reasons for such differences. This paper investigates the reasons for geographical differences in CAM use by comparing CAM users from four geographical areas (major cities, inner regional, outer region, rural/remote) across a range of health status, healthcare satisfaction, neighbourhood and community factors.
Methods
A cross-sectional survey of 1,427 participants from the Australian Longitudinal Study on Women's Health (ALSWH) conducted in 2009.
Results
The average total cost of consultations with CAM practitioners was $416 per annum and was highest for women in the major cities, declining with increasing distance from capital cities/remoteness (p < 0.001). The average total cost of self-prescribed CAM was $349 per annum, but this did not significantly differ across geographical areas. The increased use of CAM in rural and remote areas appears to be influenced by poorer access to conventional medical care (p < 0.05) and a greater sense of community (p < 0.05) amongst these rural and remote residents. In contrast to the findings of previous research this study found that health status was not associated with the differences in CAM use between urban and non-urban areas.
Conclusion
It appears that a number of factors influence the different levels of CAM use across the urban/non-urban divide. Further research is needed to help tease out and understand these factors. Such research will help support health care policy and practice with regards to this topic.
doi:10.1186/1472-6882-11-85
PMCID: PMC3198987  PMID: 21981986
15.  The ProPrems trial: investigating the effects of probiotics on late onset sepsis in very preterm infants 
BMC Infectious Diseases  2011;11:210.
Background
Late onset sepsis is a frequent complication of prematurity associated with increased mortality and morbidity. The commensal bacteria of the gastrointestinal tract play a key role in the development of healthy immune responses. Healthy term infants acquire these commensal organisms rapidly after birth. However, colonisation in preterm infants is adversely affected by delivery mode, antibiotic treatment and the intensive care environment. Altered microbiota composition may lead to increased colonisation with pathogenic bacteria, poor immune development and susceptibility to sepsis in the preterm infant.
Probiotics are live microorganisms, which when administered in adequate amounts confer health benefits on the host. Amongst numerous bacteriocidal and nutritional roles, they may also favourably modulate host immune responses in local and remote tissues. Meta-analyses of probiotic supplementation in preterm infants report a reduction in mortality and necrotising enterocolitis. Studies with sepsis as an outcome have reported mixed results to date.
Allergic diseases are increasing in incidence in "westernised" countries. There is evidence that probiotics may reduce the incidence of these diseases by altering the intestinal microbiota to influence immune function.
Methods/Design
This is a multi-centre, randomised, double blinded, placebo controlled trial investigating supplementing preterm infants born at < 32 weeks' gestation weighing < 1500 g, with a probiotic combination (Bifidobacterium infantis, Streptococcus thermophilus and Bifidobacterium lactis). A total of 1,100 subjects are being recruited in Australia and New Zealand. Infants commence the allocated intervention from soon after the start of feeds until discharge home or term corrected age. The primary outcome is the incidence of at least one episode of definite (blood culture positive) late onset sepsis before 40 weeks corrected age or discharge home. Secondary outcomes include: Necrotising enterocolitis, mortality, antibiotic usage, time to establish full enteral feeds, duration of hospital stay, growth measurements at 6 and 12 months' corrected age and evidence of atopic conditions at 12 months' corrected age.
Discussion
Results from previous studies on the use of probiotics to prevent diseases in preterm infants are promising. However, a large clinical trial is required to address outstanding issues regarding safety and efficacy in this vulnerable population. This study will address these important issues.
Trial registration
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN012607000144415
The product "ABC Dophilus Probiotic Powder for Infants®", Solgar, USA has its 3 probiotics strains registered with the Deutsche Sammlung von Mikroorganismen und Zellkulturen (DSMZ - German Collection of Microorganisms and Cell Cultures) as BB-12 15954, B-02 96579, Th-4 15957.
doi:10.1186/1471-2334-11-210
PMCID: PMC3199779  PMID: 21816056
16.  Maximising retention in a longitudinal study of genital Chlamydia trachomatis among young women in Australia 
BMC Public Health  2011;11:156.
Background
Cohort studies are an important study design however they are difficult to implement, often suffer from poor retention, low participation and bias. The aims of this paper are to describe the methods used to recruit and retain young women in a longitudinal study and to explore factors associated with loss to follow up.
Methods
The Chlamydia Incidence and Re-infection Rates Study (CIRIS) was a longitudinal study of Australian women aged 16 to 25 years recruited from primary health care clinics. They were followed up via the post at three-monthly intervals and required to return questionnaires and self collected vaginal swabs for chlamydia testing. The protocol was designed to maximise retention in the study and included using recruiting staff independent of the clinic staff, recruiting in private, regular communication with study staff, making the follow up as straightforward as possible and providing incentives and small gifts to engender good will.
Results
The study recruited 66% of eligible women. Despite the nature of the study (sexual health) and the mobility of the women (35% moved address at least once), 79% of the women completed the final stage of the study after 12 months. Loss to follow up bias was associated with lower education level [adjusted hazard ratio (AHR): 0.7 (95% Confidence Interval (CI): 0.5, 1.0)], recruitment from a sexual health centre as opposed to a general practice clinic [AHR: 1.6 (95% CI: 1.0, 2.7)] and previously testing positive for chlamydia [AHR: 0.8 (95% CI: 0.5, 1.0)]. No other factors such as age, numbers of sexual partners were associated with loss to follow up.
Conclusions
The methods used were considered effective for recruiting and retaining women in the study. Further research is needed to improve participation from less well-educated women.
doi:10.1186/1471-2458-11-156
PMCID: PMC3061916  PMID: 21385471
17.  'The difference in determinants of Chlamydia trachomatis and Mycoplasma genitalium in a sample of young Australian women.' 
Background
Differences in the determinants of Chlamydia trachomatis ('chlamydia') and Mycoplasma genitalium (MG) genital infection in women are not well understood.
Methods
A cohort study of 16 to 25 year old Australian women recruited from primary health care clinics, aimed to determine chlamydia and MG prevalence and incidence. Vaginal swabs collected at recruitment were used to measure chlamydia and MG prevalence, organism-load and chlamydia-serovar a cross-sectional analysis undertaken on the baseline results is presented here.
Results
Of 1116 participants, chlamydia prevalence was 4.9% (95% CI: 2.9, 7.0) (n = 55) and MG prevalence was 2.4% (95% CI: 1.5, 3.3) (n = 27). Differences in the determinants were found - chlamydia not MG, was associated with younger age [AOR:0.9 (95% CI: 0.8, 1.0)] and recent antibiotic use [AOR:0.4 (95% CI: 0.2, 1.0)], and MG not chlamydia was associated with symptoms [AOR:2.1 (95% CI: 1.1, 4.0)]. Having two or more partners in last 12 months was more strongly associated with chlamydia [AOR:6.4 (95% CI: 3.6, 11.3)] than MG [AOR:2.2 (95% CI: 1.0, 4.6)] but unprotected sex with three or more partners was less strongly associated with chlamydia [AOR:3.1 (95%CI: 1.0, 9.5)] than MG [AOR:16.6 (95%CI: 2.0, 138.0)]. Median organism load for MG was 100 times lower (5.7 × 104/swab) than chlamydia (5.6 × 106/swab) (p < 0.01) and not associated with age or symptoms for chlamydia or MG.
Conclusions
These results demonstrate significant chlamydia and MG prevalence in Australian women, and suggest that the differences in strengths of association between numbers of sexual partners and unprotected sex and chlamydia and MG might be due to differences in the transmission dynamics between these infections.
doi:10.1186/1471-2334-11-35
PMCID: PMC3038161  PMID: 21284887
18.  Young pregnant women's views on the acceptability of screening for chlamydia as part of routine antenatal care 
BMC Public Health  2010;10:505.
Background
In pregnancy, untreated chlamydia infection has been associated with adverse outcomes for both mother and infant. Like most women, pregnant women infected with chlamydia do not report genital symptoms, and are therefore unlikely to be aware of their infection. The aim of this study was to determine the acceptability of screening pregnant women aged 16-25 years for chlamydia as part of routine antenatal care.
Methods
As part of a larger prospective, cross-sectional study of pregnant women aged 16-25 years attending antenatal services across Melbourne, Australia, 100 women were invited to participate in a face-to-face, semi structured interview on the acceptability of screening for chlamydia during pregnancy. Women infected with chlamydia were oversampled (n = 31).
Results
Women had low levels of awareness of chlamydia before the test, retained relatively little knowledge after the test and commonly had misconceptions around chlamydia transmission, testing and sequelae. Women indicated a high level of acceptance and support for chlamydia screening, expressing their willingness to undertake whatever care was necessary to ensure the health of their baby. There was a strong preference for urine testing over other methods of specimen collection. Women questioned why testing was not already conducted alongside other antenatal STI screening tests, particularly in view of the risks chlamydia poses to the baby. Women who tested positive for chlamydia had mixed reactions, however, most felt relief and gratitude at having had chlamydia detected and reported high levels of partner support.
Conclusions
Chlamydia screening as part of routine antenatal care was considered highly acceptable among young pregnant women who recognized the benefits of screening and strongly supported its implementation as part of routine antenatal care. The acceptability of screening is important to the uptake of chlamydia screening in future antenatal screening strategies.
doi:10.1186/1471-2458-10-505
PMCID: PMC2933724  PMID: 20723264
19.  GPs' decision-making when prescribing medicines for breastfeeding women: Content analysis of a survey 
BMC Research Notes  2010;3:82.
Background
Many breastfeeding women seek medical care from general practitioners (GPs) for various health problems and GPs may consider prescribing medicines in these consultations. Prescribing medicines to a breastfeeding mother may lead to untimely cessation of breastfeeding or a breastfeeding mother may be denied medicines due to the possible risk to her infant, both of which may lead to unwanted consequences. Information on factors governing GPs' decision-making and their views in such situations is limited.
Methods
GPs providing shared maternity care at the Royal Women's Hospital, Melbourne were surveyed using an anonymous postal survey to determine their knowledge, attitudes and practices on medicines and breastfeeding, in 2007/2008 (n = 640). Content analysis of their response to a question concerning decision-making about the use of medicine for a breastfeeding woman was conducted. A thematic network was constructed with basic, organising and global themes.
Results
335 (52%) GPs responded to the survey, and 253 (76%) provided information on the last time they had to decide about the use of medicine for a breastfeeding woman. Conditions reported were mastitis (24%), other infections (24%) and depressive disorders (21%). The global theme that emerged was "complexity of managing risk in prescribing for breastfeeding women". The organising themes were: certainty around decision-making; uncertainty around decision-making; need for drug information to be available, consistent and reliable; joint decision-making; the vulnerable "third party" and infant feeding decision. Decision-making is a spectrum from a straight forward decision, such as treatment of mastitis, to a complicated one requiring multiple inputs and consideration. GPs use more information seeking and collaboration in decision-making when they perceive the problem to be more complex, for example, in postnatal depression.
Conclusion
GPs feel that prescribing medicines for breastfeeding women is a contentious issue. They manage the risk of prescribing by gathering information and assessing the possible effects on the breastfed infant. Without evidence-based information, they sometimes recommend cessation of breastfeeding unnecessarily.
doi:10.1186/1756-0500-3-82
PMCID: PMC2860488  PMID: 20331898
20.  Incentive payments to general practitioners aimed at increasing opportunistic testing of young women for chlamydia: a pilot cluster randomised controlled trial 
BMC Public Health  2010;10:70.
Background
Financial incentives have been used for many years internationally to improve quality of care in general practice. The aim of this pilot study was to determine if offering general practitioners (GP) a small incentive payment per test would increase chlamydia testing in women aged 16 to 24 years, attending general practice.
Methods
General practice clinics (n = 12) across Victoria, Australia, were cluster randomized to receive either a $AUD5 payment per chlamydia test or no payment for testing 16 to 24 year old women for chlamydia. Data were collected on the number of chlamydia tests and patient consultations undertaken by each GP over two time periods: 12 month pre-trial and 6 month trial period. The impact of the intervention was assessed using a mixed effects logistic regression model, accommodating for clustering at GP level.
Results
Testing increased from 6.2% (95% CI: 4.2, 8.4) to 8.8% (95% CI: 4.8, 13.0) (p = 0.1) in the control group and from 11.5% (95% CI: 4.6, 18.5) to 13.4% (95% CI: 9.5, 17.5) (p = 0.4) in the intervention group. Overall, the intervention did not result in a significant increase in chlamydia testing in general practice. The odds ratio for an increase in testing in the intervention group compared to the control group was 0.9 (95% CI: 0.6, 1.2). Major barriers to increased chlamydia testing reported by GPs included a lack of time, difficulty in remembering to offer testing and a lack of patient awareness around testing.
Conclusions
A small financial incentive alone did not increase chlamydia testing among young women attending general practice. It is possible small incentive payments in conjunction with reminder and feedback systems may be effective, as may higher financial incentive payments. Further research is required to determine if financial incentives can increase testing in Australian general practice, the type and level of financial scheme required and whether incentives needs to be part of a multi-faceted package.
Trial Registration
Australian New Zealand Clinical Trial Registry ACTRN12608000499381.
doi:10.1186/1471-2458-10-70
PMCID: PMC2841675  PMID: 20158918
21.  Blinding Techniques in Randomized Controlled Trials of Laser Therapy: An Overview and Possible Solution 
Low-level laser therapy has evidence accumulating about its effectiveness in a variety of medical conditions. We reviewed 51 double blind randomized controlled trials (RCTs) of laser treatment. Analysis revealed 58% of trials showed benefit of laser over placebo. However, less than 5% of the trials had addressed beam disguise or allocation concealment in the laser machines used. Many of the trials used blinding methods that rely on staff cooperation and are therefore open to interference or bias. This indicates significant deficiencies in laser trial methodology. We report the development and preliminary testing of a novel laser machine that can blind both patient and operator to treatment allocation without staff participation. The new laser machine combines sealed preset and non-bypassable randomization codes, decoy lights and sound, and a conical perspex tip to overcome laser diode glow detection.
doi:10.1093/ecam/nem085
PMCID: PMC2586311  PMID: 18955233
low-level laser therapy; allocation concealment; treatment blinding
22.  Genital Candida Species Detected in Samples from Women in Melbourne, Australia, before and after Treatment with Antibiotics 
Journal of Clinical Microbiology  2006;44(9):3213-3217.
Vulvovaginal candidiasis (VVC) remains a common cause of morbidity, with three-quarters of women affected during their lifetimes. Use of antibiotics is an acknowledged trigger for VVC, which adversely affects women's physical and emotional health. Knowledge of patterns of genital Candida species-level identification is important for management, as Candida species other than Candida albicans often fail first-line treatment. A community sample of women with no vaginal symptoms, and who were prescribed antibiotics, was recruited into this study, where the incidence of genital colonization by various Candida species was documented, as well as symptoms of VVC plus relevant associations, before and after treatment with antibiotics. Self-collected low vaginal swabs were taken prior to and 8 days after completion of antibiotic treatment, and data on various potential risk factors for VVC were collected simultaneously, with complete data being available for 233 participants. Baseline Candida species colonization was present in 21% of women (95% confidence intervals [CI], 17% to 27%), rising to 37% (95% CI, 31% to 44%) after antibiotic treatment. The primary species detected for either period was C. albicans (73%), with Candida glabrata detected in around 20%. Self-assessed proneness to VVC after antibiotic treatment and baseline colonization with Candida spp. were significantly associated with symptomatic VVC after antibiotic treatment. For microbiologically proven candidiasis, VVC symptoms had a sensitivity of 57% and a specificity of 91%. When physicians prescribe antibiotics, the history of risk of VVC is one issue that physicians should discuss with women, particularly those who are self-identified as being prone to VVC. Furthermore, we recommend that definitive microbiological diagnoses be made for women with recurrent symptoms or those failing initial treatment, to guide appropriate therapy.
doi:10.1128/JCM.00218-06
PMCID: PMC1594690  PMID: 16954250
23.  Effect of lactobacillus in preventing post-antibiotic vulvovaginal candidiasis: a randomised controlled trial 
BMJ : British Medical Journal  2004;329(7465):548.
Objective To test whether oral or vaginal lactobacillus can prevent vulvovaginitis after antibiotic treatment.
Design Randomised, placebo controlled, double blind, factorial 2×2 trial.
Setting Fifty general practices and 16 pharmacies in Melbourne, Australia.
Participants Non-pregnant women aged 18-50 years who required a short course of oral antibiotics for a non-gynaecological infection: 278 were enrolled in the study, and results were available for 235.
Interventions Lactobacillus preparations taken orally or vaginally, or both, from enrolment until four days after completion of their antibiotic course.
Main outcome measures Participants' reports of symptoms of post-antibiotic vulvovaginitis, with microbiological evidence of candidiasis provided by a self obtained vaginal swab.
Results Overall, 55/235 (23% (95% confidence interval 18% to 29%)) women developed post-antibiotic vulvovaginitis. Compared with placebo, the odds ratio for developing post-antibiotic vulvovaginitis with oral lactobacillus was 1.06 (95% confidence interval 0.58 to 1.94) and with vaginal lactobacillus 1.38 (0.75 to 2.54). Compliance with antibiotics and interventions was high. The trial was terminated after the second interim analysis because of lack of effect of the interventions. Given the data at this time, the chances of detecting a significant reduction in vulvovaginitis with oral or vaginal lactobacillus treatment were less than 0.032 and 0.0006 respectively if the trial proceeded to full enrolment.
Conclusions The use of oral or vaginal forms of lactobacillus to prevent post-antibiotic vulvovaginitis is not supported by these results. Further research on this subject is unlikely to be fruitful, unless new understandings about the pathogenesis of post-antibiotic vulvovaginitis indicate a possible role for lactobacillus.
doi:10.1136/bmj.38210.494977.DE
PMCID: PMC516107  PMID: 15333452
24.  The PAV trial: Does lactobacillus prevent post-antibiotic vulvovaginal candidiasis? Protocol of a randomised controlled trial [ISRCTN24141277] 
Background
Complementary and alternative medicines are used by many consumers, and increasingly are being incorporated into the general practitioner's armamentarium. Despite widespread usage, the evidence base for most complementary therapies is weak or non-existent. Post-antibiotic vulvovaginitis is a common problem in general practice, for which complementary therapies are often used. A recent study in Melbourne, Australia, found that 40% of women with a past history of vulvovaginitis had used probiotic Lactobacillus species to prevent or treat post-antibiotic vulvovaginitis. There is no evidence that this therapy is effective. This study aims to test whether oral or vaginal lactobacillus is effective in the prevention of post-antibiotic vulvovaginitis.
Methods/design
A randomised placebo-controlled blinded 2 × 2 factorial design is being used. General practitioners or pharmacists approach non-pregnant women, aged 18–50 years, who present with a non-genital infection requiring a short course of oral antibiotics, to participate in the study. Participants are randomised in a four group factorial design either to oral lactobacillus powder or placebo and either vaginal lactobacillus pessaries or placebo. These interventions are taken while on antibiotics and for four days afterwards or until symptoms of vaginitis develop. Women self collect a vaginal swab for culture of Candida species and complete a survey at baseline and again four days after completing their study medications. The sample size (a total of 496 – 124 in each factorial group) is calculated to identify a reduction of half in post-antibiotic vulvovaginitis from 23%, while allowing for a 25% drop-out. An independent Data Monitoring Committee is supervising the trial. Analysis will be intention-to-treat, with two pre-specified main comparisons: (i) oral lactobacillus versus placebo and (ii) vaginal lactobacillus versus placebo.
doi:10.1186/1471-2296-5-5
PMCID: PMC521199  PMID: 15046642

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