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1.
Pharmacoepidemiol Drug Saf ; 32(2): 238-247, 2023 Feb.
Article in English | MEDLINE | ID: mdl-36070795

ABSTRACT

PURPOSE: Infection is a major complication following joint replacement (JR) surgery. However, little data exist regarding antibiotic utilisation following primary JR and how use changes with subsequent revision surgery. This study aimed to examine variation in antibiotic utilisation rates before and after hip replacement surgery in those revised for infection, revised for other reasons and those without revision. METHODS: This retrospective cohort analysis used linked data from the Australian Orthopaedic Association National Joint Replacement Registry and Australian Government Pharmaceutical Benefits Scheme. Patients were included if undergoing total hip replacement (THR) for osteoarthritis in private hospitals between 2002 and 2017. Three groups were examined: primary THR with no subsequent revision (n = 102 577), primary THR with a subsequent revision for reasons other than periprosthetic joint infection (PJI) (n = 3156) and primary THR with a subsequent revision for PJI (n = 520). Monthly antibiotic utilisation rates and prevalence rate ratios (PRRs) with 95% confidence intervals (CIs) were calculated in the 2 years pre- and post-THR. RESULTS: Prior to primary THR antibiotic utilisation was 9%-10%. After primary THR, antibiotic utilisation rates were higher among patients revised for PJI (PRR 1.69, 95% CI 1.60-1.79) compared to non-revised patients, while the utilisation rate was lower in patients revised for reasons other than infection (PRR 0.96, 95% CI 0.93-0.98). For those revised for infection, antibiotic utilisation post-revision surgery was two times higher than those revised for other reasons (PRR 2.16, 95% CI 2.08-2.23). Utilisation of injectable antibiotics including, vancomycin, flucloxacillin and cephazolin was higher in those revised for PJI patients 0-2 weeks following surgery but not in those revised for other reasons compared to the non-revised group. CONCLUSIONS: Ongoing antibiotic utilisation after primary surgery may be an early signal of problems with the THR and should be a prompt for primary care physicians to refer patients to specialists for further appropriate investigations and management.


Subject(s)
Arthroplasty, Replacement, Hip , Orthopedics , Prosthesis-Related Infections , Humans , Cohort Studies , Retrospective Studies , Anti-Bacterial Agents , Reoperation , Prosthesis-Related Infections/surgery , Australia , Registries
2.
Clin Orthop Relat Res ; 479(10): 2181-2190, 2021 Oct 01.
Article in English | MEDLINE | ID: mdl-34232146

ABSTRACT

BACKGROUND: When analyzing the outcomes of joint arthroplasty, an important factor to consider is patient comorbidities. The presence of multiple comorbidities has been associated with longer hospital stays, more postoperative complications, and increased mortality. The American Society of Anesthesiologists (ASA) physical status classification system score is a measure of a patient's overall health and has been shown to be associated with complications and mortality after joint arthroplasty. The Rx-Risk score is another measure for determining the number of different health conditions for which an individual is treated, with a possible score ranging from 0 to 47. QUESTIONS/PURPOSES: For patients undergoing THA or TKA, we asked: (1) Which metric, the Rx-Risk score or the ASA score, correlates more closely with 30- and 90-day mortality after TKA or THA? (2) Is the Rx-Risk score correlated with the ASA score? METHODS: This was a retrospective analysis of the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) database linked to two other national databases, the National Death Index (NDI) database and the Pharmaceutical Benefits Scheme (PBS), a dispensing database. Linkage to the NDI provided outcome information on patient death, including the fact of and date of death. Linkage to the PBS was performed to obtain records of all medicines dispensed to patients undergoing a joint replacement procedure. Patients were included if they had undergone either a THA (119,076 patients, 131,336 procedures) or TKA (182,445 patients, 215,712 procedures) with a primary diagnosis of osteoarthritis, performed between 2013 and 2017. We excluded patients with missing ASA information (THA: 3% [3055 of 119,076]; TKA: 2% [4095 of 182,445]). This left 127,761 primary THA procedures performed in 116,021 patients (53% [68,037 of 127,761] were women, mean age 68 ± 11 years) and 210,501 TKA procedures performed in 178,350 patients (56% [117,337 of 210,501] were women, mean age 68 ± 9 years) included in this study. Logistic regression models were used to determine the concordance of the ASA and Rx-Risk scores and 30-day and 90-day postoperative mortality. The Spearman correlation coefficient (r) was used to estimate the correlation between the ASA score and Rx-Risk score. All analyses were performed separately for THAs and TKAs. RESULTS: We found both the ASA and Rx-Risk scores had high concordance with 30-day mortality after THA (ASA: c-statistic 0.83 [95% CI 0.79 to 0.86]; Rx-Risk: c-statistic 0.82 [95% CI 0.79 to 0.86]) and TKA (ASA: c-statistic 0.73 [95% CI 0.69 to 0.78]; Rx-Risk: c-statistic 0.74 [95% CI 0.70 to 0.79]). Although both scores were strongly associated with death, their correlation was moderate for patients undergoing THA (r = 0.45) and weak for TKA (r = 0.38). However, the median Rx-Risk score did increase with increasing ASA score. For example, for THAs, the median Rx-Risk score was 1, 3, 5, and 7 for ASA scores 1, 2, 3, and 4, respectively. For TKAs, the median Rx-Risk score was 2, 4, 5, and 7 for ASA scores 1, 2, 3, and 4, respectively. CONCLUSION: The ASA physical status and RxRisk were associated with 30-day and 90-day mortality; however, the scores were only weakly to moderately correlated with each other. This suggests that although both scores capture a similar level of patient illness, each score may be capturing different aspects of health. The Rx-Risk may be used as a complementary measure to the ASA score. LEVEL OF EVIDENCE: Level III, therapeutic study.


Subject(s)
Arthroplasty, Replacement, Hip , Arthroplasty, Replacement, Knee , Comorbidity , Outcome Assessment, Health Care/methods , Postoperative Complications/classification , Postoperative Complications/mortality , Aged , Australia/epidemiology , Female , Humans , Male , Middle Aged , Quality Improvement , Registries , Reoperation/statistics & numerical data , Retrospective Studies , Risk Factors
3.
Pharmacoepidemiol Drug Saf ; 30(7): 843-857, 2021 07.
Article in English | MEDLINE | ID: mdl-33634545

ABSTRACT

INTRODUCTION: Information regarding availability of electronic healthcare databases in the Asia-Pacific region is critical for planning vaccine safety assessments particularly, as COVID-19 vaccines are introduced. This study aimed to identify data sources in the region, potentially suitable for vaccine safety surveillance. This manuscript is endorsed by the International Society for Pharmacoepidemiology (ISPE). METHODS: Nineteen countries targeted for database reporting were identified using published country lists and review articles. Surveillance capacity was assessed using two surveys: a 9-item introductory survey and a 51-item full survey. Survey questions related to database characteristics, covariate and health outcome variables, vaccine exposure characteristics, access and governance, and dataset linkage capability. Other questions collated research/regulatory applications of the data and local publications detailing database use for research. RESULTS: Eleven databases containing vaccine-specific information were identified across 8 countries. Databases were largely national in coverage (8/11, 73%), encompassed all ages (9/11, 82%) with population size from 1.4 to 52 million persons. Vaccine exposure information varied particularly for standardized vaccine codes (5/11, 46%), brand (7/11, 64%) and manufacturer (5/11, 46%). Outcome data were integrated with vaccine data in 6 (55%) databases and available via linkage in 5 (46%) databases. Data approval processes varied, impacting on timeliness of data access. CONCLUSIONS: Variation in vaccine data availability, complexities in data access including, governance and data release approval procedures, together with requirement for data linkage for outcome information, all contribute to the challenges in building a distributed network for vaccine safety assessment in the Asia-Pacific and globally. Common data models (CDMs) may help expedite vaccine safety research across the region.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Health Information Interoperability , Pharmacoepidemiology/methods , Product Surveillance, Postmarketing/methods , Asia/epidemiology , COVID-19/epidemiology , COVID-19/immunology , COVID-19/virology , COVID-19 Vaccines/administration & dosage , Databases, Factual/statistics & numerical data , Electronic Health Records/statistics & numerical data , Geography , Humans , International Cooperation , Pacific Islands/epidemiology , Pharmacoepidemiology/organization & administration , Pharmacovigilance , Product Surveillance, Postmarketing/statistics & numerical data , SARS-CoV-2/immunology
4.
Aust N Z J Public Health ; 43(5): 496-503, 2019 Oct.
Article in English | MEDLINE | ID: mdl-31535432

ABSTRACT

OBJECTIVE: To provide insights into complexities of seeking access to state and federal cross-jurisdictional data for linkage with the Australian Childhood Immunisation Register (ACIR). We provide recommendations for improving access and receipt of linked datasets involving Australian Government-administered data. METHODS: We describe requirements for linking eleven federal and state data sources to establish a national linked dataset for safety evaluation of vaccines. The required data linkage methodology for integrating cross-jurisdictional data sources is also described. RESULTS: Extensive negotiation was required with 18 different agencies for 21 separate authorisations and 12 ethics approvals. Three variations of the 'best practice' linkage model were implemented. Australian Government approval requests spanned nearly four years from initial request for data, with a further year before ACIR data transfer to the linkage agency. CONCLUSIONS: Integration of immunisation registers with other data collections is achievable in Australia but infeasible for routine and rapid identification of vaccine safety concerns. Lengthy authorisation requirements, convoluted disparate application processes and inconsistencies in data supplied all contribute to delayed data availability. Implications for public health: Delayed data access for safety surveillance prevents timely epidemiological reviews. Poor responsiveness to safety concerns may erode public confidence, compromising effectiveness of vaccination programs through reduced participation.


Subject(s)
Communicable Disease Control/statistics & numerical data , Data Collection/legislation & jurisprudence , Immunization , Medical Record Linkage , Registries , Vaccination/statistics & numerical data , Australia , Child , Humans , Immunization Programs , Policy Making , Vaccines
5.
BMJ Open ; 9(5): e026486, 2019 05 05.
Article in English | MEDLINE | ID: mdl-31061039

ABSTRACT

OBJECTIVES: The aim of this study was to compare effectiveness and safety of low-strength and high-strength direct oral anticoagulants (DOACs) with warfarin in the Australian Veteran population. DESIGN: Sequential cohort study using inverse probability of treatment weighting (IPTW) and propensity score matching. Initiators of high-strength (apixaban 5 mg, dabigatran 150 mg, rivaroxaban 20 mg) and low-strength DOACS (apixaban 2.5 mg, dabigatran 110 mg, rivaroxaban 15 mg) were compared with warfarin initiators. SETTING: Australian Government Department of Veterans' Affairs claims database. PARTICIPANTS: 4836 patients who initiated oral anticoagulants (45.8%, 26.0% and 28.2% on low-strength, high-strength DOACs and warfarin, respectively) between August 2013 and March 2015. Mean age was 85, 75 and 83 years for low-strength, high-strength DOACs and warfarin initiators, respectively. MAIN OUTCOME MEASURES: One-year risk of hospitalisation for ischaemic stroke, any bleeding event or haemorrhagic stroke. Secondary outcomes were 1-year risk of hospitalisation for myocardial infarction and death. RESULTS: Using the IPTW method, no difference in risk of ischaemic stroke or bleeding was found with low-strength DOACs compared with warfarin. As a class, no increased risk of myocardial infarction was found for low-strength DOACs, however, risk was elevated for apixaban (HR 2.25, 95% CI 1.23 to 4.13). For high-strength DOACs, no difference was found for ischaemic stroke compared with warfarin, however, there was a significant reduction in risk of bleeding events (HR 0.63, 95% CI 0.44 to 0.89) and death (HR 0.40, 95% CI 0.28 to 0.58). Propensity score matching showed no difference in risk of ischaemic stroke or bleeding. CONCLUSION: We found that in the practice setting both DOAC formulations were similar to warfarin with regard to effectiveness and had no increased risk of bleeding.


Subject(s)
Anticoagulants/administration & dosage , Myocardial Infarction/prevention & control , Stroke/prevention & control , Warfarin/administration & dosage , Administration, Oral , Aged , Aged, 80 and over , Australia/epidemiology , Comparative Effectiveness Research , Dabigatran/administration & dosage , Databases, Factual , Female , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Humans , Logistic Models , Male , Myocardial Infarction/epidemiology , Propensity Score , Pyrazoles/administration & dosage , Pyridones/administration & dosage , Rivaroxaban/administration & dosage , Stroke/epidemiology , Stroke/etiology , Veterans
6.
Vaccine ; 37(2): 280-288, 2019 01 07.
Article in English | MEDLINE | ID: mdl-30503081

ABSTRACT

OBJECTIVE: To determine whether differences in combination DTaP vaccine types at 2, 4 and 6 months of age were associated with mortality (all-cause or non-specific), within 30 days of vaccination. DESIGN: Observational nationwide cohort study. SETTING: Linked population data from the Australian Childhood Immunisation Register and National Death Index. PARTICIPANTS: Australian infants administered a combination trivalent, quadrivalent or hexavalent DTaP vaccine (DTaP types) between January 1999 and December 2010 at 2, 4 and 6 months as part of the primary vaccination series. The study population included 2.9, 2.6, & 2.3 million children in the 2, 4 and 6 month vaccine cohorts, respectively. MAIN OUTCOME MEASURES: Infants were evaluated for the primary outcome of all-cause mortality within 30 days. A secondary outcome was non-specific mortality (unknown cause of death) within 30 days of vaccination. Non-specific mortality was defined as underlying or other cause of death codes, R95 'Sudden infant death syndrome', R96 'Other sudden death, cause unknown', R98 'Unattended death', R99 'Other ill-defined and unspecified cause of mortality' or where no cause of death was recorded. RESULTS: The rate of 30 day all-cause mortality was low and declined from 127.4 to 59.3 deaths per 100,000 person-years between 2 and 6 month cohorts. When compared with trivalent DTaP vaccines, no elevated risk in all-cause or non-specific mortality was seen with any quadrivalent or hexavalent DTaP vaccines, for any cohort. CONCLUSION: Use of routine DTaP combination vaccines with differing disease antigens administered during the first six months of life is not associated with infant mortality.


Subject(s)
Diphtheria-Tetanus-acellular Pertussis Vaccines/administration & dosage , Infant Mortality , Vaccination/statistics & numerical data , Whooping Cough/prevention & control , Australia/epidemiology , Cohort Studies , Diphtheria-Tetanus-acellular Pertussis Vaccines/adverse effects , Female , Humans , Infant , Male , Medical Record Linkage , Registries , Vaccines, Combined/administration & dosage , Vaccines, Combined/adverse effects , Whooping Cough/epidemiology
7.
PLoS One ; 11(3): e0151079, 2016.
Article in English | MEDLINE | ID: mdl-26943925

ABSTRACT

BACKGROUND: Appropriate understanding of health information by patients with cardiovascular disease (CVD) is fundamental for better management of risk factors and improved morbidity, which can also benefit their quality of life. OBJECTIVES: To assess the relationship between health literacy and health-related quality of life (HRQoL) in patients with ischaemic heart disease (IHD), and to investigate the role of sociodemographic and clinical variables as possible confounders. METHODS: Cross-sectional study of patients with IHD recruited from a stratified sample of general practices in two Australian states (Queensland and South Australia) between 2007 and 2009. Health literacy was measured using a validated questionnaire and classified as inadequate, marginal, or adequate. Physical and mental components of HRQoL were assessed using the Medical Outcomes Study Short Form (SF12) questionnaire. Analyses were adjusted for confounders (sociodemographic variables, clinical history of IHD, number of CVD comorbidities, and CVD risk factors) using multiple linear regression. RESULTS: A total sample of 587 patients with IHD (mean age 72.0±8.4 years) was evaluated: 76.8% males, 84.2% retired or pensioner, and 51.4% with up to secondary educational level. Health literacy showed a mean of 39.6±6.7 points, with 14.3% (95%CI 11.8-17.3) classified as inadequate. Scores of the physical component of HRQoL were 39.6 (95%CI 37.1-42.1), 42.1 (95%CI 40.8-43.3) and 44.8 (95%CI 43.3-46.2) for inadequate, marginal, and adequate health literacy, respectively (p-value for trend = 0.001). This association persisted after adjustment for confounders. Health literacy was not associated with the mental component of HRQoL (p-value = 0.482). Advanced age, lower educational level, disadvantaged socioeconomic position, and a larger number of CVD comorbidities adversely affected both, health literacy and HRQoL. CONCLUSION: Inadequate health literacy is a contributing factor to poor physical functioning in patients with IHD. Increasing health literacy may improve HRQoL and reduce the impact of IHD among patients with this chronic CVD.


Subject(s)
General Practice/statistics & numerical data , Health Literacy/statistics & numerical data , Myocardial Ischemia/epidemiology , Quality of Life , Aged , Aged, 80 and over , Cross-Sectional Studies , Demography , Female , Humans , Male , Myocardial Ischemia/psychology , Queensland/epidemiology , South Australia/epidemiology
8.
Soc Sci Med ; 109: 1-9, 2014 May.
Article in English | MEDLINE | ID: mdl-24657639

ABSTRACT

Deliberative inclusive approaches, such as citizen juries, have been used to engage citizens on a range of issues in health care and public health. Researchers engaging with the public to inform policy and practice have adapted the citizen jury method in a variety of ways. The nature and impact of these adaptations has not been evaluated. We systematically searched Medline (PubMED), CINAHL and Scopus databases to identify deliberative inclusive methods, particularly citizens' juries and their adaptations, deployed in health research. Identified studies were evaluated focussing on principles associated with deliberative democracy: inclusivity, deliberation and active citizenship. We examined overall process, recruitment, evidence presentation, documentation and outputs in empirical studies, and the relationship of these elements to theoretical explications of deliberative inclusive methods. The search yielded 37 papers describing 66 citizens' juries. The review demonstrated that the citizens' jury model has been extensively adapted. Inclusivity has been operationalised with sampling strategies that aim to recruit representative juries, although these efforts have produced mixed results. Deliberation has been supported through use of steering committees and facilitators to promote fair interaction between jurors. Many juries were shorter duration than originally recommended, limiting opportunity for constructive dialogue. With respect to citizenship, few juries' rulings were considered by decision-making bodies thereby limiting transfer into policy and practice. Constraints in public policy process may preclude use of the 'ideal' citizens' jury with potential loss of an effective method for informed community engagement. Adapted citizens' jury models provide an alternative: however, this review demonstrates that special attention should be paid to recruitment, independent oversight, jury duration and moderation.


Subject(s)
Community Participation , Decision Making , Health Policy , Australia , Humans
9.
Clin Trials ; 10(3): 483-94, 2013.
Article in English | MEDLINE | ID: mdl-23568940

ABSTRACT

BACKGROUND: We examined parents' consent preferences and understanding of an opt-in or opt-out invitation to participate in data linkage for post-marketing safety surveillance of childhood vaccines. METHODS: A single-blind parallel-group randomised controlled trial: 1129 families of babies born at a South Australian hospital in 2009 were sent information at 6 weeks post-partum, explaining data linkage of childhood immunisation and hospital records for vaccine safety surveillance, with 4 weeks to opt in or opt out by reply form, telephone, or email. At 10 weeks post-partum, 1026 (91%) parents were followed up by telephone interview. RESULTS: In both the opt-in (n = 564) and opt-out arms (n = 565), four-fifths of the parents recalled receiving the information (81% vs. 83%, P = 0.35), three-fifths reported reading it (63% vs. 67%, P = 0.11), but only two-fifths correctly identified the health records to be linked (43% vs. 39%, P = 0.21). Parents who actively consented (opted in) were more likely than those who passively consented (did not opt out) to recall the information (100% vs. 83%, P < 0.001), report reading it (94% vs. 67%, P < 0.001), and correctly identify the data sources (60% vs. 39%, P < 0.001). Most parents supported data linkage for vaccine safety surveillance (94%) and trusted its privacy protections (84%). Most parents wished to have minimal or no direct involvement, preferring either opt-out consent (40%) or no consent (30%). A quarter (24%) of parents indicated opt-in consent should be sought; of these, 8% requested consent prior to every use, 5% preferred to give broad consent just once and 11% preferred periodic renewal. Three-fifths of the parents gave higher priority to rapid vaccine safety surveillance (61%) rather than first seeking parental consent (21%), and one in seven was undecided (15%). Although 91% of parents reported that their babies were fully immunised (76%) or under-immunised (15%), and trusted vaccines as safe (90%), three-fifths (62%) were very or somewhat concerned about serious reactions. LIMITATIONS: The context of data linkage is limited to vaccine safety surveillance. Only recall and understanding retained at 1 month post enrolment were measured. CONCLUSIONS: This trial demonstrates that informed consent for a population-based surveillance programme cannot realistically be achieved using mail-based opt-in and opt-out approaches. While recall and understanding of the study's purpose were better among parents who actively consented (opted in) compared with parents who passively consented (did not opt out), participation was substantially lower (21% vs. 96% respectively). Most parents appeared to have a poor understanding of data linkage for vaccine safety surveillance; nonetheless, they supported data linkage. They preferred a system utilising opt-out consent or no consent to one using opt-in consent.


Subject(s)
Data Collection , Parental Consent/statistics & numerical data , Randomized Controlled Trials as Topic/ethics , Vaccines/adverse effects , Female , Humans , Interviews as Topic , Logistic Models , Mothers , Single-Blind Method , South Australia
10.
Vaccine ; 30(28): 4167-74, 2012 Jun 13.
Article in English | MEDLINE | ID: mdl-22546331

ABSTRACT

INTRODUCTION: We sought community opinion on consent alternatives when linking childhood immunisation and hospital attendance records for the purpose of vaccine safety surveillance. METHODS: We conducted computer-assisted telephone interviewing (CATI) of a sample of rural and metropolitan residents of South Australia in 2011. RESULTS: Of 2002 households interviewed (response rate 55.6%), 96.4% supported data linkage for postmarketing surveillance of vaccines; very few were completely opposed (1.5%) or undecided (2.2%). The majority (75.3%) trusted the privacy protections used in data linkage and most wished to have minimal or no direct involvement, preferring either opt-out consent (40.4%) or no consent (30.6%). A quarter of respondents (24.6%) favoured opt-in consent, but their preferences were divergent; half requested consent be sought prior to every use (11.4%) while the remainder preferred to give broad consent just once (3.4%) or renewed at periodic intervals (9.8%). Over half of the respondents gave higher priority to rapid vaccine safety surveillance (56.5%) rather than first seeking parental consent (26.6%) and one in seven was undecided (14.5%). Although 91.6% of respondents believed childhood vaccines are safe, over half (53.1%) were very or somewhat concerned that a vaccine could cause a serious reaction. Nevertheless, 92.4% of the parents in the sample (556/601) reported every child in their care as being fully immunised according to the National Immunisation Program schedule. Only 3.7% of parents (22/601) reported one or more children as under immunised, and 3.9% (23/601) reported that none of their children were immunised. CONCLUSIONS: This survey demonstrates that data linkage for vaccine safety surveillance has substantial community support and that a system utilising opt-out consent or no consent was preferred to one using opt-in consent. These findings should inform public health policy and practice; data linkage should be established where feasible to address limitations in passive surveillance systems.


Subject(s)
Adverse Drug Reaction Reporting Systems/organization & administration , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Drug-Related Side Effects and Adverse Reactions/epidemiology , Public Opinion , Vaccination/adverse effects , Vaccines/adverse effects , Adolescent , Adult , Aged , Aged, 80 and over , Female , Humans , Interviews as Topic , Male , Middle Aged , South Australia , Vaccines/administration & dosage , Young Adult
11.
J Med Ethics ; 38(10): 619-25, 2012 Oct.
Article in English | MEDLINE | ID: mdl-22518045

ABSTRACT

INTRODUCTION: No consent for health and medical research is appropriate when the criteria for a waiver of consent are met, yet some ethics committees and data custodians still require informed consent. METHODS: A single-blind parallel-group randomised controlled trial: 1129 families of children born at a South Australian hospital were sent information explaining data linkage of childhood immunisation and hospital records for vaccine safety surveillance with 4 weeks to opt in or opt out by reply form, telephone or email. A subsequent telephone interview gauged the intent of 1026 parents (91%) in relation to their actions and the sociodemographic differences between participants and non-participants in each arm. RESULTS: The participation rate was 21% (n=120/564) in the opt-in arm and 96% (n=540/565) in the opt-out arm (χ(2) (1 df) = 567.7, p<0.001). Participants in the opt-in arm were more likely than non-participants to be older, married/de facto, university educated and of higher socioeconomic status. Participants in the opt-out arm were similar to non-participants, except men were more likely to opt out. Substantial proportions did not receive, understand or properly consider study invitations, and opting in or opting out behaviour was often at odds with parents' stated underlying intentions. CONCLUSIONS: The opt-in approach resulted in low participation and a biased sample that would render any subsequent data linkage unfeasible, while the opt-out approach achieved high participation and a representative sample. The waiver of consent afforded under current privacy regulations for data linkage studies meeting all appropriate criteria should be granted by ethics committees, and supported by data custodians. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry ACTRN12610000332022.


Subject(s)
Adverse Drug Reaction Reporting Systems , Data Collection , Parental Consent , Patient Selection , Vaccines/adverse effects , Adult , Australia , Female , Humans , Male , Middle Aged , Population Surveillance , Safety , Single-Blind Method
12.
Trials ; 12: 1, 2011 Jan 04.
Article in English | MEDLINE | ID: mdl-21199584

ABSTRACT

BACKGROUND: The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. METHODS/DESIGN: Single-centre, single-blind, randomised controlled trial (RCT) stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response). A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. DISCUSSION: The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12610000332022.


Subject(s)
Data Collection , Health Knowledge, Attitudes, Practice , Parental Consent , Parents/psychology , Population Surveillance , Product Surveillance, Postmarketing , Research Design , Vaccines/adverse effects , Data Collection/statistics & numerical data , Health Behavior , Health Care Surveys , Humans , Immunization Programs , Immunization Schedule , Infant , Medical Record Linkage , Parental Consent/statistics & numerical data , Product Surveillance, Postmarketing/statistics & numerical data , Single-Blind Method , Socioeconomic Factors , South Australia/epidemiology
13.
Aust N Z J Public Health ; 31(4): 379-81, 2007 Aug.
Article in English | MEDLINE | ID: mdl-17725021

ABSTRACT

OBJECTIVE: The use of benzodiazepines by elderly people is of limited therapeutic benefit and increases the risk of adverse events. This study aimed to examine the extent to which benzodiazepines are prescribed for elderly Australians. METHODS: Data for 3,970 individuals aged 65 years or more were extracted from a general practice database. Benzodiazepine prescriptions for 2002 were reviewed. RESULTS: Overall, 16% (95% CI 11-21%) of elderly patients had at least one benzodiazepine prescription. Females were almost twice as likely as males to be prescribed a benzodiazepine and prescription prevalence increased with age. CONCLUSIONS: Despite risks, benzodiazepines are widely prescribed for the elderly. Limited availability and cost of alternative therapies and pressures on the primary care system in Australia may contribute to their continued overuse. IMPLICATIONS: The prescribing of benzodiazepines for elderly Australians needs to be reduced by better managing sleep and anxiety problems.


Subject(s)
Benzodiazepines/therapeutic use , Family Practice , Aged , Aged, 80 and over , Australia , Female , Humans , Male , Medical Audit
14.
Addict Behav ; 31(11): 1947-58, 2006 Nov.
Article in English | MEDLINE | ID: mdl-16503093

ABSTRACT

AIMS: To collect data on the behaviours associated with the prescription of pharmacotherapies (bupropion, acamprosate and naltrexone) for nicotine and alcohol dependence in Australian clinical practice. DESIGN: Self-administered questionnaire. SETTING: Australian clinical practice. PARTICIPANTS: Three specialties, psychiatrists, gastroenterologists and general practitioners (GPs) were defined by the Health Insurance Commission's derived major specialty classification codes and stratified by state (and territory) as well as rural and remote metropolitan area classification. A total of 2680 surveys were sent (670 psychiatrists, 82 gastroenterologists and 1928 GPs) with 1291 surveys used in the final analysis (329 psychiatrists, 37 gastroenterologists and 925 GPs). INTERVENTIONS: A 10-page, 46-item survey was distributed by the HIC. The initial survey was sent in March 2003 and sent a subsequent two times to non-responding physicians. MEASUREMENTS: Characteristics of physicians and their therapeutic preferences in managing patients with nicotine or alcohol dependence. FINDINGS: The majority of physicians identified and provided advice to patients who smoked and consumed alcohol at levels harmful to health. Fourteen percent used a formal alcohol-screening instrument, 4% were familiar with the 5 As' of a smoking cessation strategy and less than a third had undertaken any formal training in providing brief advice. The majority of physicians perceived pharmacotherapies to be an effective treatment strategy and indicated adjuncts improved likelihood of behaviour modification. Predictors of pharmacotherapy prescribing included working in a large clinical practice, having an additional mental health qualification and training in provision of brief advice. CONCLUSIONS: Physicians are in a strong position, and are encouraged to, manage additive disorders. Scope exists to improve prescribing of pharmacotherapies for nicotine and alcohol dependence by enhancing appropriate counselling skills and making explicit the nature of a comprehensive treatment regime as an adjunct to medicines.


Subject(s)
Substance-Related Disorders/drug therapy , Acamprosate , Alcohol Deterrents/therapeutic use , Alcoholism/drug therapy , Australia , Bupropion/therapeutic use , Dopamine Uptake Inhibitors/therapeutic use , Female , Health Care Surveys/methods , Humans , Male , Middle Aged , Naltrexone/therapeutic use , Narcotic Antagonists/therapeutic use , Nicotine/administration & dosage , Taurine/analogs & derivatives , Taurine/therapeutic use , Tobacco Use Disorder/drug therapy
15.
Aust Fam Physician ; 33(1-2): 91-3, 2004.
Article in English | MEDLINE | ID: mdl-14988973

ABSTRACT

OBJECTIVE: To quantify how frequently general practitioners in Australia prescribe antibiotics for acute bronchitis, which antibiotics are used, and whether there are subgroups of patients who might benefit from their use. DESIGN AND SETTING: A retrospective descriptive study using 3 sets of data: Australian Sentinel Practice Research Network, the Bettering the Evaluation and Care of Health (BEACH) Program, and the General Practice Research Network (GPRN). RESULTS: Over 50% of all patients with 'acute bronchitis' had either chest or one or more systemic signs on physical examination. The rate of antibiotic prescribing for acute bronchitis was 79.6% of acute bronchitis visits using BEACH data 2001-2002 and varied from 68.6 (95% CI: 62.8-74.5%) in 2001 to 78.7 (95% CI: 72.2-85.2%) in 1999 using GPRN data. Penicillins, followed by macrolides, were the most commonly prescribed antibiotics. DISCUSSION: Australian GPs frequently prescribe antibiotics for 'acute bronchitis' despite guidelines to the contrary. One reason may be that many patients present with chest or systemic signs.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Bronchitis/drug therapy , Drug Prescriptions/statistics & numerical data , Family Practice/statistics & numerical data , Acute Disease , Australia , Bronchitis/diagnosis , Drug Utilization , Humans , Retrospective Studies
16.
Fam Pract ; 20(6): 685-9, 2003 Dec.
Article in English | MEDLINE | ID: mdl-14701893

ABSTRACT

BACKGROUND: Depression is a common disease in primary care and produces significant morbidity in the community. Little is known about the outcomes of depression in general practice. OBJECTIVES: This research set out to explore both the longitudinal management and outcomes of depression as seen in general practice. METHODS: The Medic-GP database is a collection of the medical records of >50 000 people seen in nine Australian general practices. It was used to follow the management of depressed patients over 4-5 years. Records from 1994-1995 were searched for depression or similar words. Individual records of patients whose notes mentioned depression were randomly selected and examined to determine if they were diagnosed with depression. Records of patients who were diagnosed as suffering from depression were examined to determine progress over the ensuing 5 years. RESULTS: Six hundred of 5889 patients were examined in detail. A total of 382 patients (63.7%) were diagnosed with depression; 219 had been diagnosed during this time interval. The main findings were 64.7% of patients were female; 93.6% of patients received an antidepressant at some time during the study; 16% of patients were referred to a psychiatrist; 7.3% were hospitalized; 30% of patients who ceased antidepressants without a recurrence had courses of antidepressants of 3 months or less; and only 22.5% of patients had a single episode of depression. CONCLUSION: Unlike cross-sectional studies, this study has shown a high rate of prescription of antidepressants. GPs often prescribed short courses of antidepressants, and depression behaves as a chronic, recurrent disease.


Subject(s)
Antidepressive Agents/therapeutic use , Depression/drug therapy , Family Practice/statistics & numerical data , Psychotherapy , Adolescent , Adult , Aged , Child , Child, Preschool , Databases, Factual , Depression/epidemiology , Female , Follow-Up Studies , Humans , Longitudinal Studies , Male , Medical Records Systems, Computerized , Middle Aged , South Australia/epidemiology , Treatment Outcome
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