General Practice and Primary Care - Research Publications
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ItemNo Preview AvailablePatients' preferences for involvement in treatment decision making in Japan.(Springer Science and Business Media LLC, 2004-03-01)BACKGROUND: A number of previous studies have suggested that the Japanese have few opportunities to participate in medical decision-making, as a result both of entrenched physician paternalism and national characteristics of dependency and passivity. The hypothesis that Japanese patients would wish to participate in treatment decision-making if adequate information were provided, and the decision to be made was clearly identified, was tested by interview survey. METHODS: The subjects were diabetic patients at a single outpatient clinic in Kyoto. One of three case study vignettes (pneumonia, gangrene or cancer) was randomly assigned to each subject and, employing face-to-face interviews, the subjects were asked what their wishes would be as patients, for treatment information, participation in decision-making and family involvement. RESULTS: 134 patients participated in the study, representing a response rate of 90%. The overall proportions of respondents who preferred active, collaborative, and passive roles were 12%, 71%, and 17%, respectively. Respondents to the cancer vignette were less likely to prefer an active role and were more likely to prefer family involvement in decision-making compared to non-cancer vignette respondents. If a physician's recommendation conflicted with their own wishes, 60% of the respondents for each vignette answered that they would choose to respect the physician's opinion, while few respondents would give the family's preference primary importance. CONCLUSIONS: Our study suggested that a majority of Japanese patients have positive attitudes towards participation in medical decision making if they are fully informed. Physicians will give greater patient satisfaction if they respond to the desire of patients for participation in decision-making.
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ItemNo Preview AvailableThe PAV trial: does lactobacillus prevent post-antibiotic vulvovaginal candidiasis? Protocol of a randomised controlled trial [ISRCTN24141277].(Springer Science and Business Media LLC, 2004-03-28)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 x 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.
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ItemThe association between intimate partner violence, alcohol and depression in family practice(BMC, 2010-09-27)BACKGROUND: Depressive symptoms, intimate partner violence and hazardous drinking are common among patients attending general practice. Despite the high prevalence of these three problems; the relationship between them remains relatively unexplored. METHODS: This paper explores the association between depressive symptoms, ever being afraid of a partner and hazardous drinking using cross-sectional screening data from 7667 randomly selected patients from a large primary care cohort study of 30 metropolitan and rural general practices in Victoria, Australia. The screening postal survey included the Center for Epidemiological Studies Depression Scale, the Fast Alcohol Screening Test and a screening question from the Composite Abuse Scale on ever being afraid of any intimate partner. RESULTS: 23.9% met criteria for depressive symptoms. A higher proportion of females than males (20.8% vs. 7.6%) reported ever being afraid of a partner during their lifetime (OR 3.2, 95%CI 2.5 to 4.0) and a lower proportion of females (12%) than males (25%) were hazardous drinkers (OR 0.4; 95%CI 0.4 to 0.5); and a higher proportion of females than males (20.8% vs. 7.6%) reported ever being afraid of a partner during their lifetime (OR 3.2, 95%CI 2.5 to 4.0). Men and women who had ever been afraid of a partner or who were hazardous drinkers had on average higher depressive symptom scores than those who had never been afraid or who were not hazardous drinkers. There was a stronger association between depressive symptoms and ever been afraid of a partner compared to hazardous drinking for both males (ever afraid of partner; Diff 6.87; 95% CI 5.42, 8.33; p < 0.001 vs. hazardous drinking in last year; Diff 1.07, 95% CI 0.21, 1.94; p = 0.015) and females (ever afraid of partner; Diff 5.26; 95% CI 4.55, 5.97; p < 0.001 vs. hazardous drinking in last year; Diff 2.23, 95% CI 1.35, 3.11; p < 0.001), even after adjusting for age group, income, employment status, marital status, living alone and education level. CONCLUSIONS: Strategies to assist primary care doctors to recognise and manage intimate partner violence and hazardous drinking in patients with depression may lead to better outcomes from management of depression in primary care.
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ItemWomen's evaluation of abuse and violence care in general practice: a cluster randomised controlled trial (weave)(BMC, 2010-01-02)BACKGROUND: Intimate partner abuse (IPA) is a major public health problem with serious implications for the physical and psychosocial wellbeing of women, particularly women of child-bearing age. It is a common, hidden problem in general practice and has been under-researched in this setting. Opportunities for early intervention and support in primary care need to be investigated given the frequency of contact women have with general practice. Despite the high prevalence and health consequences of abuse, there is insufficient evidence for screening in primary care settings. Furthermore, there is little rigorous evidence to guide general practitioners (GPs) in responding to women identified as experiencing partner abuse. This paper describes the design of a trial of a general practice-based intervention consisting of screening for fear of partner with feedback to GPs, training for GPs, brief counselling for women and minimal practice organisational change. It examines the effect on women's quality of life, mental health and safety behaviours. METHODS/DESIGN: weave is a cluster randomised controlled trial involving 40 general practices in Victoria, Australia. Approximately 500 women (16-50 years) seen by the GP in the previous year are mailed a short lifestyle survey containing an item to screen for IPA. Women who indicate that they were afraid of a partner/ex-partner in the last year and provide contact details are invited to participate. Once baseline data are collected, GPs are randomly assigned to either a group involving healthy relationship and responding to IPA training plus inviting women for up to 6 sessions of counselling or to a group involving basic education and usual care for women. Outcomes will be evaluated by postal survey at 6 and 12 months following delivery of the intervention. There will be an economic evaluation, and process evaluation involving interviews with women and GPs, to inform understanding about implementation and outcomes. DISCUSSION: The weave trial responds to an urgent need for more evidence on what can be achieved in primary care with regard to responding to women who experience IPA. It will provide important knowledge about the effectiveness of a brief method of screening, professional IPA training program and brief counselling for women. TRIAL REGISTRATION: [ACTRN12608000032358].
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ItemAcupuncture for menopausal vasomotor symptoms: study protocol for a randomised controlled trial (vol 15, 224, 2014)(BIOMED CENTRAL LTD, 2015-03-12)
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ItemAcupuncture for menopausal vasomotor symptoms: study protocol for a randomised controlled trial(BMC, 2014-06-12)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.
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ItemThe design and analysis of matched-pair cluster randomised trials( 2012)Cluster randomised trials (CRTs) are studies in which groups (clusters) of individuals, such as a group of patients that see the same general practitioner (GP), are randomised to one of two (or more) treatment conditions that are being compared, rather than the individuals themselves. CRTs have certain design and analytical challenges not found in trials that randomise individuals. One design issue is related to the greater risk of imbalance of important prognostic factors between trial arms, especially when the number of clusters randomised is small. In order to avoid chance imbalance on important factors, a matched-pair design is often employed, where clusters are paired according to a number of different characteristics, such as size of the practice,geographical location or baseline score on the outcome of interest, and then one cluster within each pair is randomised to the intervention arm and the other to the control arm. To date, the literature is unclear regarding when it is sensible to match clusters in pairs in the design of a CRT in order to provide greater assurance that known prognostic factors are balanced between the trial arms, especially when the number of clusters is small. Furthermore, there are a number of unique design and analytical challenges associated with the matched-pair design related to having only one cluster in each combination of trial arm and pair of clusters. This research aimed to provide guidance to assist researchers and applied statisticians in deciding when to use a matched-pair CRT and how best to analyse data from such studies. The research aim was addressed with four major components of original research. Firstly, a systematic review was performed to investigate recent practice in primary care research use of the matched-pair design and it sets the context for the research. Three extensive simulation studies were performed to address some of the gaps identified in the literature. The first two simulation studies evaluated the performance of selected analytical methods that can be applied to the matched-pair CRT for continuous and binary outcomes, respectively. The third simulation study compared the relative efficiency of the matched-pair design, in terms of gains in precision for estimation of the intervention effect, to the stratified and completely randomised designs. This research led to the development of a set of practical recommendations for the design and analysis of CRTs within primary care research. Choosing the best randomisation approach for CRTs is not straightforward and the design of each study needs to be considered carefully. Even when the matched-pair design minimises the chance of imbalance of prognostic factors and provides the greatest statistical efficiency, the practical and analytical limitations of using a matched-pair design may ultimately determine the final choice of study design. It is hoped the practical recommendations offered will assist researchers and applied statisticians in choosing the best design for future proposed CRTs.
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ItemEffectiveness of a Mental Health Service Navigation Website (Link) for Young Adults: Randomized Controlled Trial(JMIR Publications, 2019-10-17)Background: Mental health and substance use disorders are the main causes of disability among adolescents and young adults yet fewer than half experiencing these problems seek professional help. Young people frequently search the Web for health information and services, suggesting that Web-based modalities might promote help-seeking among young people who need it. To support young people in their help-seeking, we developed a Web-based mental health service navigation website called Link. Link is based on the Theory of Planned Behavior and connects young people with treatment based on the type and severity of mental health symptoms that they report Objective: The study aimed to investigate the effect of Link on young people’s positive affect (PA) compared with usual help-seeking strategies immediately post intervention. Secondary objectives included testing the effect of Link on negative affect (NA), psychological distress, barriers to help-seeking, and help-seeking intentions. Methods: Young people, aged between 18 and 25 years, were recruited on the Web from an open access website to participate in a randomized controlled trial. Participants were stratified by gender and psychological distress into either the intervention arm (Link) or the control arm (usual help-seeking strategies). Baseline, immediate postintervention, 1-month, and 3-month surveys were self-reported and administered on the Web. Measures included the PA and NA scales, Kessler psychological distress scale (K10), barriers to adolescent help-seeking scale (BASH), and the general help-seeking questionnaire (GHSQ). Results: In total 413 young people were recruited to the trial (intervention, n=205; control, n=208) and 78% (160/205) of those randomized to the intervention arm visited the Link website. There was no evidence to support a difference between the intervention and control arms on the primary outcome, with PA increasing equally by approximately 30% between baseline and 3 months in both arms. NA decreased for the intervention arm compared with the control arm with a difference of 1.4 (95% CI 0.2-2.5) points immediately after the intervention and 2.6 (95% CI 1.1-4.1) at 1 month. K10 scores were unchanged and remained high in both arms. No changes were found on the BASH or GHSQ; however, participants in the intervention arm appeared more satisfied with their help-seeking process and outcomes at 1 and 3 months postintervention. The process of prompting young people to seek mental health information and services appears to improve their affective state and increase help-seeking intentions, regardless of whether they use a Web-based dedicated youth-focused tool, such as Link, or their usual search strategies. However, young people report greater satisfaction using tools designed specifically for them, which may encourage future help-seeking. The ability of Web-based tools to match mental health needs with appropriate care should be explored further.
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ItemAn interactive workshop plus locally adapted guidelines can improve General Practitioners asthma management and knowledge: A cluster randomised trial in the Australian setting(BMC, 2008-04-20)BACKGROUND: A cluster randomised trial was conducted to determine the effectiveness of locally adapted practice guidelines and education about paediatric asthma management, delivered to general practitioners (GPs) in small group interactive workshops. METHODS: Twenty-nine practices were randomly allocated to one of three study arms. Australian asthma management guidelines were adapted to accommodate characteristics of the local area. GPs in the intervention arm (Group 1, n = 18 GPs) participated in a small group based education program and were provided with the adapted guidelines. One control arm (Group 2, n = 18 GPs) received only the adapted guidelines, while the other control arm (Group 3, n = 15 GPs) received an unrelated education intervention. GPs' knowledge, attitudes and management of paediatric asthma was assessed. RESULTS: Post intervention, intervention arm GPs were no more likely to provide a written asthma action plan, but were better able to assess the severity of asthma attack (Group 1vs Group 2 p = 0.05 and Group 1 vs Group 3 p = 0.01), better able to identify patients at high risk of severe attack (Group 1vs Group 3 p = 0.06), and tended to score higher on the asthma knowledge questionnaire (Group 1 vs Group 2 p = 0.06 and Group 1 vs Group 3 p = 0.2). Most intervention arm GPs felt more confident than control GPs to manage acute asthma attack and ongoing management of infrequent episodic asthma. CONCLUSION: Using interactive small group workshops to disseminate locally adapted guidelines was associated with improvement in GP's knowledge and confidence to manage asthma, but did not change GP's self-reported provision of written action plans.
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ItemObserved intra-cluster correlation coefficients in a cluster survey sample of patient encounters in general practice in Australia.(Springer Science and Business Media LLC, 2004-12-22)BACKGROUND: Cluster sample study designs are cost effective, however cluster samples violate the simple random sample assumption of independence of observations. Failure to account for the intra-cluster correlation of observations when sampling through clusters may lead to an under-powered study. Researchers therefore need estimates of intra-cluster correlation for a range of outcomes to calculate sample size. We report intra-cluster correlation coefficients observed within a large-scale cross-sectional study of general practice in Australia, where the general practitioner (GP) was the primary sampling unit and the patient encounter was the unit of inference. METHODS: Each year the Bettering the Evaluation and Care of Health (BEACH) study recruits a random sample of approximately 1,000 GPs across Australia. Each GP completes details of 100 consecutive patient encounters. Intra-cluster correlation coefficients were estimated for patient demographics, morbidity managed and treatments received. Intra-cluster correlation coefficients were estimated for descriptive outcomes and for associations between outcomes and predictors and were compared across two independent samples of GPs drawn three years apart. RESULTS: Between April 1999 and March 2000, a random sample of 1,047 Australian general practitioners recorded details of 104,700 patient encounters. Intra-cluster correlation coefficients for patient demographics ranged from 0.055 for patient sex to 0.451 for language spoken at home. Intra-cluster correlations for morbidity variables ranged from 0.005 for the management of eye problems to 0.059 for management of psychological problems. Intra-cluster correlation for the association between two variables was smaller than the descriptive intra-cluster correlation of each variable. When compared with the April 2002 to March 2003 sample (1,008 GPs) the estimated intra-cluster correlation coefficients were found to be consistent across samples. CONCLUSIONS: The demonstrated precision and reliability of the estimated intra-cluster correlations indicate that these coefficients will be useful for calculating sample sizes in future general practice surveys that use the GP as the primary sampling unit.