Reducing antibiotic prescribing in Australian general practice: time for a national strategy.

In Australia, the antibiotic resistance crisis may be partly alleviated by reducing antibiotic use in general practice, which has relatively high prescribing rates - antibiotics are mostly prescribed for acute respiratory infections, for which they provide only minor benefits. Current surveillance is inadequate for monitoring community antibiotic resistance rates, prescribing rates by indication, and serious complications of acute respiratory infections (which antibiotic use earlier in the infection may have averted), making target setting difficult. Categories of interventions that may support general practitioners to reduce prescribing antibiotics are: regulatory (eg, changing the default to "no repeats" in electronic prescribing, changing the packaging of antibiotics to facilitate tailored amounts of antibiotics for the right indication and restricting access to prescribing selected antibiotics to conserve them), externally administered (eg, academic detailing and audit and feedback on total antibiotic use for individual GPs), interventions that GPs can individually implement (eg, delayed prescribing, shared decision making, public declarations in the practice about conserving antibiotics, and self-administered audit), supporting GPs' access to near-patient diagnostic testing, and public awareness campaigns. Many unanswered clinical research questions remain, including research into optimal implementation methods. Reducing antibiotic use in Australian general practice will require a range of approaches (with various intervention categories), a sustained effort over many years and a commitment of appropriate resources and support.

Antibiotics for acute respiratory infections in general practice: comparison of prescribing rates with guideline recommendations.

OBJECTIVE: To compare the current rate of antibiotic prescribing for acute respiratory infections (ARIs) in Australian general practice with the recommendations in the most widely consulted therapeutic guidelines in Australia (Therapeutic Guidelines). DESIGN AND SETTING: Comparison of general practice activity data for April 2010 - March 2015 (derived from Bettering the Evaluation and Care of Health [BEACH] study) with estimated rates of prescribing recommended by Therapeutic Guidelines. MAIN OUTCOME MEASURES: Antibiotic prescribing rates and estimated guideline-recommended rates per 100 encounters and per full-time equivalent (FTE) GP per year for eight ARIs; number of prescriptions nationally per year. RESULTS: An estimated mean 5.97 million (95% CI, 5.69-6.24 million) ARI cases per year were managed in Australian general practice with at least one antibiotic, equivalent to an estimated 230 cases per FTE GP/year (95% CI, 219-240 cases/FTE/year). Antibiotics are not recommended by the guidelines for acute bronchitis/bronchiolitis (current prescribing rate, 85%) or influenza (11%); they are always recommended for community-acquired pneumonia (current prescribing rate, 72%) and pertussis (71%); and they are recommended for 0.5-8% of cases of acute rhinosinusitis (current prescribing rate, 41%), 20-31% of cases of acute otitis media (89%), and 19-40% cases of acute pharyngitis or tonsillitis (94%). Had GPs adhered to the guidelines, they would have prescribed antibiotics for 0.65-1.36 million ARIs per year nationally, or at 11-23% of the current prescribing rate. Antibiotics were prescribed more frequently than recommended for acute rhinosinusitis, acute bronchitis/bronchiolitis, acute otitis media, and acute pharyngitis/tonsillitis. CONCLUSIONS: Antibiotics are prescribed for ARIs at rates 4-9 times as high as those recommended by Therapeutic Guidelines. Our data provide the basis for setting absolute targets for reducing antibiotic prescribing in Australian general practice.

Identified health concerns and changes in management resulting from the Healthy Kids Check in two Queensland practices.

OBJECTIVES: To determine how many children had health problems identified by the Healthy Kids Check (HKC) and whether this resulted in changes to clinical management. DESIGN, SETTING AND PARTICIPANTS: A medical records audit from two Queensland general practices, identifying 557 files of children who undertook an HKC between January 2010 and May 2013. MAIN OUTCOME MEASURES: Child health problems identified in the medical records before, during and after the HKC. RESULTS: Most children in our sample had no problems detected in their medical record (56%), 21% had problems detected during the HKC assessment, 19% had problems detected before, and 4% after. Most frequent health concerns detected during the HKC were speech and language (20%), toileting, hearing and vision (15% each), and behavioural problems (9%). Of the 116 children with problems detected during the HKC, 19 (3% of the total sample) had these confirmed, which resulted in a change of management. No further action was recorded for 9% of children. Missing data from reviews or referral outcomes for 8% precluded analyses of these outcomes. We estimated that the change in clinical management to children with health concerns directly relating to the HKC ranged between 3% and 11%. CONCLUSIONS: Overall, data suggest that general practitioners are diligent in detecting and managing child health problems. Some of these problems were detected only during the HKC appointment, resulting in change of management for some children. Further studies are required to estimate the full benefits and harms, and particularly the false negatives and true positives, of the HKC.

Shared decision making: what do clinicians need to know and why should they bother?

Shared decision making enables a clinician and patient to participate jointly in making a health decision, having discussed the options and their benefits and harms, and having considered the patient's values, preferences and circumstances. It is not a single step to be added into a consultation, but a process that can be used to guide decisions about screening, investigations and treatments. The benefits of shared decision making include enabling evidence and patients' preferences to be incorporated into a consultation; improving patient knowledge, risk perception accuracy and patient-clinician communication; and reducing decisional conflict, feeling uninformed and inappropriate use of tests and treatments. Various approaches can be used to guide clinicians through the process. We elaborate on five simple questions that can be used: What will happen if the patient waits and watches? What are the test or treatment options? What are the benefits and harms of each option? How do the benefits and harms weigh up for the patient? Does the patient have enough information to make a choice? Although shared decision making can occur without tools, various types of decision support tools now exist to facilitate it. Misconceptions about shared decision making are hampering its implementation. We address the barriers, as perceived by clinicians. Despite numerous international initiatives to advance shared decision making, very little has occurred in Australia. Consequently, we are lagging behind many other countries and should act urgently.

Stakeholders' views on the routine use of n-of-1 trials to improve clinical care and to make resource allocation decisions for drug use.

N-of-1 trials are empirical formal tests using a within-patient randomised, double-blind, cross-over comparison of drug and placebo (or another drug), which we adapted to study individual patients' responses as a clinical tool to guide clinical management. We administered semi-structured interviews to gauge stakeholder perspectives on the possibility of using routine n-of-1 trials for this purpose. Stakeholders included government and non-government health care sector, and patient, clinician and consumer, organisations. Stakeholders supported more widespread implementation of n-of-1 trials, in a targeted fashion, with some caveats. Barriers to their widespread implementation included constraints on doctors' time, doctors' acceptance, drug company acceptance, patient willingness, and cost. Strategies for overcoming barriers included conditional Pharmaceutical Benefits Scheme listing if cost-effective. There was little consensus on which model of n-of-1 trial implementation would be most effective. We discuss different approaches to addressing the several concerns raised to enable widespread introduction of n-of-1 trials into routine clinical practice as a decision tool.

Oral prednisolone for acute otitis media in children: a pilot, pragmatic, randomised, open-label, controlled study (OPAL study).

BACKGROUND: Acute otitis media (AOM) is associated with high antibiotic prescribing rates. Antibiotics are somewhat effective in improving pain and middle ear effusion (MEE); however, they have unfavourable effects. Alternative treatments, such as corticosteroids as anti-inflammatory agents, are needed. Evidence for the efficacy of these remains inconclusive. We conducted a pilot study to test feasibility of a proposed large-scale randomised controlled trial (RCT) to assess the efficacy of corticosteroids for AOM. METHODS: We conducted a pilot, pragmatic, parallel, open-label RCT of oral corticosteroids for paediatric AOM in primary and secondary/tertiary care centres in Indonesia. Children aged 6 months-12 years with AOM were randomised to either prednisolone or control (1:1). Physicians were blinded to allocation. Our objectives were to test the feasibility of our full RCT procedures and design, and assess the mechanistic effect of corticosteroids, using tympanometry, in suppressing middle ear inflammation by reducing MEE. RESULTS: We screened 512 children; 62 (38%) of 161 eligible children were randomised and 60 were analysed for the primary clinical outcome. All study procedures were completed successfully by healthcare personnel and parents/caregivers, despite time constraints and high workload. All eligible, consenting children were appropriately randomised. One child did not take the medication and four received additional oral corticosteroids. Our revised sample size calculation verified 444 children are needed for the full RCT. Oral corticosteroids did not have any discernible effects on MEE resolution and duration. There was no correlation between pain or other symptoms and MEE change. However, prednisolone may reduce pain intensity at day 3 (Visual Analogue Scale mean difference - 7.4 mm, 95% confidence interval (CI) - 13.4 to - 1.3, p = 0.018), but cause drowsiness (relative risk (RR) 1.8, 95% CI 1.1 to 2.8, p = 0.016). Tympanometry curves at day 7 may be improved (RR 1.8, 95% CI 1.0 to 2.9). We cannot yet confirm these as effects of corticosteroids due to insufficient sample size in this pilot study. CONCLUSIONS: It is feasible to conduct a large, pragmatic RCT of corticosteroids for paediatric AOM in Indonesia. Although oral corticosteroids may reduce pain and improve tympanometry curves, it requires an adequately powered clinical trial to confirm this. TRIAL REGISTRATION: Study registry number: ACTRN12618000049279. Name of registry: the Australian New Zealand Clinical Trials Registry (ANZCTR). Date of registration: 16 January 2018.

N-of-1 randomized trials to assess the efficacy of gabapentin for chronic neuropathic pain.

OBJECTIVE: The objective of this study was to compare the efficacy of gabapentin with placebo for neuropathic pain at the individual and population levels. DESIGN: This study used an n-of-1 trial methodology with three double-blind, randomized, crossover comparisons of gabapentin with placebo. SETTING: This study was carried out at specialist outpatient clinics at two Australian hospitals. Patients. The patients are adults with chronic neuropathic pain. INTERVENTIONS: Following a dose-finding period, participants underwent three comparisons of 2-week periods on gabapentin (600-1,800 mg per day) and placebo. The dose-finding period was commenced by 112 patients, of whom 39 had no response so they did not enroll, leaving 73 trial participants. Of these, 48 completed and 7 partially completed their trials, and 18 withdrew. OUTCOME MEASURES: The five outcome measures were the visual analog scale (0-10) of pain, sleep interference and functional limitation; frequency of adverse events and medication preference. The aggregate response was determined by weighting the response to each measure equally. RESULTS: Of the 55 participants who completed at least one cycle, the aggregate response to gabapentin was better than placebo in 16 (29%), of whom 15 continued gabapentin posttrial. No difference was shown in 38 (69%), and 1 (2%) showed a better response to placebo. Fifteen of these 39 continued gabapentin posttrial. Meta-analysis of the mean scores showed lower mean (standard deviation) scores for gabapentin by 0.8 (0.2) for pain, 0.6 (0.2) for sleep interference, and 0.6 (0.2) for functional limitation. CONCLUSIONS: The response rate and mean reduction in symptoms with gabapentin were small. Gabapentin prescribing posttrial was significantly influenced by the trial results.

Oral prednisolone for acute otitis media in children: protocol of a pilot randomised, open-label, controlled study (OPAL study).

BACKGROUND: Acute otitis media (AOM) is an acute inflammation of the middle ear commonly found in children, for which antibiotics are frequently prescribed. However, antibiotics are beneficial for only one third of AOM cases, and then, with only modest benefit. Since antibiotic use leads to risk of side effects and resistance, effective alternative treatments are required. Corticosteroids are a candidate because of their anti-inflammatory effects, although evidence of their efficacy and harms is insufficient. Accordingly, we plan a large, rigorous clinical trial to test this. Initially, we will test pre-specified methods and procedures (including the overall process, resources, management, and scientific components) in a pilot study of corticosteroids for AOM, which will inform a future, definitive trial. METHODS: This is a pilot pragmatic, randomised, open-label, single-blind, controlled study of corticosteroids as either monotherapy or an addition to antibiotics in 60 children aged 6 months to 12 years with AOM in two cities (Jakarta and Bekasi) in Indonesia. We will randomise eligible children to prednisolone or control. We will also stratify by disease severity and randomise those with mild AOM to expectant observation plus prednisolone or observation alone and those with severe AOM to prednisolone plus antibiotic or antibiotic alone. Our outcomes are to determine (1) recruitment rates, (2) the success of the study procedures, (3) the ability to measure planned outcomes of the proposed main study, (4) the compliance to study visits and study medication, and (5) verification of the sample size calculation for the main study. We will also assess middle ear effusion using tympanometry as part of a mechanistic sub-study. DISCUSSION: This study will test all procedures in preparation for the main study, including several potential obstacles and challenges from the perspective of participating physicians, nurses, pharmacists, and the parents of eligible children. This information will be useful for developing strategies to overcome practical and procedural issues. This study may also provide information about the effects of corticosteroids on middle ear effusion in AOM. TRIAL REGISTRATION: Study registry number: ACTRN12618000049279. Name of registry: the Australian New Zealand Clinical Trials Registry (ANZCTR). Date of registration: 16 January 2018.

Reducing inappropriate polypharmacy: the process of deprescribing.

Inappropriate polypharmacy, especially in older people, imposes a substantial burden of adverse drug events, ill health, disability, hospitalization, and even death. The single most important predictor of inappropriate prescribing and risk of adverse drug events in older patients is the number of prescribed drugs. Deprescribing is the process of tapering or stopping drugs, aimed at minimizing polypharmacy and improving patient outcomes. Evidence of efficacy for deprescribing is emerging from randomized trials and observational studies. A deprescribing protocol is proposed comprising 5 steps: (1) ascertain all drugs the patient is currently taking and the reasons for each one; (2) consider overall risk of drug-induced harm in individual patients in determining the required intensity of deprescribing intervention; (3) assess each drug in regard to its current or future benefit potential compared with current or future harm or burden potential; (4) prioritize drugs for discontinuation that have the lowest benefit-harm ratio and lowest likelihood of adverse withdrawal reactions or disease rebound syndromes; and (5) implement a discontinuation regimen and monitor patients closely for improvement in outcomes or onset of adverse effects. Whereas patient and prescriber barriers to deprescribing exist, resources and strategies are available that facilitate deliberate yet judicious deprescribing and deserve wider application.

Increasing access to consumer health organisations among patients with chronic disease - a randomised trial of a print-based intervention.

AIM: To assess whether a print-based intervention led to increased contact with consumer health organisations (CHOs) by general practice patients with chronic disease. BACKGROUND: CHOs can enhance people's capacity to manage chronic illness by providing information, education and psychosocial support. However, these organisations appear to be grossly under-utilised by patients and clinicians. METHODS: A total of 276 patients completed a computer-assisted telephone interview before randomisation to an intervention (n = 141) or control (n = 135) group. The intervention consisted of mailed printed materials designed to encourage contact with a CHO relevant to the patient's main diagnosed chronic condition. Follow-up interviews were conducted 4 and 12 months later. FINDINGS: Patients with conditions other than diabetes who received the intervention were twice as likely as those in the control group to contact a consumer health organisation during the 12-month study period: 41% versus 21% (P < 0.001). No such effect was found for diabetes patients, probably because of pre-existing high levels of contact with diabetes organisations. The intervention package received strong patient endorsement. Low-intensity interventions may be effective in improving access to CHOs for patients with chronic disease.

Primary care management of otitis media among Australian children.

Acute otitis media (AOM) is diagnosed on the basis of acute onset of pain and fever; a red, bulging tympanic membrane; and middle ear effusion. AOM is managed with analgesia (paracetamol or non-steroidal anti-inflammatory drugs). Antibiotic therapy is minimally effective for most patients; it is most effective for children < 2 years with bilateral otitis media and for children with discharging ears. National guidelines recommend antibiotic therapy for Indigenous children with AOM. Evidence for corticosteroids, topical analgesia and xylitol are scant. Otitis media with effusion (OME) is diagnosed as the presence of middle ear effusion (type B tympanogram or immobile tympanic membrane on pneumatic otoscopy) without AOM criteria. Well children with OME with no speech and language delays can be observed for the first 3 months; perform audiological evaluation and refer to an ear, nose and throat (ENT) specialist if they have bilateral hearing impairment > 30 dB or persistent effusion. Children with effusions persisting longer than 3 months can benefit from a 2-4-week course of amoxycillin. Chronic suppurative otitis media is a chronic discharge through a tympanic membrane perforation. It is managed with regular ear cleaning (dry mopping or povidone-iodine [Betadine] washouts) until discharge resolves; topical ear drops (eg, ciprofloxacin); audiological evaluation; and ENT review.

Consumer health organisations for people with diabetes and arthritis: who contacts them and why?

As health systems worldwide confront a growing prevalence of chronic disease, attention has focused on self-management as a strategy for delivering better outcomes for individuals and the health system. Consumer health organisations (CHOs) offer an existing, but under-utilised, resource for supporting self-management. This paper reports on a study designed to investigate the use of CHOs among people with diabetes and arthritis. A cross-sectional computer-assisted telephone interview survey was completed by 279 people who had made contact with one of four CHOs in Queensland, Australia, between July and August 2006. Self-reported data were collected on the participants' socio-demographic and health-related characteristics, pathways to, use and benefits of CHO contact and subsequent health actions. People contacted CHOs primarily to obtain further information about their condition or to access services or products. Most believed CHOs offered useful information relevant to their health and better ways to manage health problems. Almost half reported that they had started exercising or changed diet following contact. More than two-thirds of diabetes contacts had been directed to the organisation by a health professional, compared with less than one-third of those with arthritis. Correspondingly, people with diabetes reported shorter periods between diagnosis and contact and more prior contact with the organisation and were less likely to wish they had made contact earlier. The study concludes that people who contact CHOs report benefits and health actions conducive to better self-management. The integration of CHOs within the wider health system, as in the case of the diabetes CHO in this study, is likely to facilitate contact. Further attention to the role of these organisations as part of a comprehensive approach to chronic illness care is warranted.

Factors associated with the number of lesions excised for each skin cancer: a study of primary care physicians in Queensland, Australia.

OBJECTIVE: To assess physician, patient, and skin lesion characteristics that affect the number of benign skin lesions excised by primary care physicians for each skin cancer. DESIGN: Prospective study collecting clinical, patient, and histopathologic details of excisions or biopsies of skin lesions by random samples of primary care physicians. SETTING: Southeast Queensland involving traditional family medicine physicians (n = 104; response rate, 53.9%) and family medicine physicians working in 27 primary care skin cancer clinics (n = 50; response rate, 75.0%). PARTICIPANTS: Of 28 755 skin examinations recorded during the study, 11 403 skin lesions were excised or biopsied; 97.5% of the excised lesions had clinical and histologic diagnoses recorded. MAIN OUTCOME MEASURES: Number of lesions needed to excise or biopsy (NNE) for 1 melanoma (pigmented lesions only) and NNE for 1 nonmelanoma skin cancer (nonpigmented lesions only). RESULTS: The NNE for nonpigmented lesions (n = 8139) was 1.5 (95% confidence interval, 1.4-1.6) and for pigmented lesions (n = 2977) was 19.6 (16.2-22.9). The NNE estimates were up to 8 times lower if the physician thought the lesion was likely to be malignant and up to 2.5 times higher if there was strong patient pressure to excise. The NNE estimates varied by other physician-, patient-, and lesion-related variables. CONCLUSIONS: Clinical impressions of excised skin lesions were strongly associated with NNE estimates. By focusing on pigmented skin lesions and by addressing the physician- and patient-specific factors identified, the effectiveness of future training for primary care physicians in the clinical management of skin cancer could be improved.