Antibiotic prescribing for acute infections in synchronous telehealth consultations: a systematic review and meta-analysis.

BACKGROUND: Antibiotic overprescribing is a major concern that contributes to the problem of antibiotic resistance. AIM: To assess the effect on antibiotic prescribing in primary care of telehealth (TH) consultations compared with face-to-face (F2F). DESIGN & SETTING: Systematic review and meta-analysis of adult or paediatric patients with a history of a community-acquired acute infection (respiratory, urinary, or skin and soft tissue). Studies were included that compared synchronous TH consultations (phone or video-based) to F2F consultations in primary care. METHOD: PubMed, Embase, Cochrane CENTRAL (inception-2021), clinical trial registries and citing-cited references of included studies were searched. Two review authors independently screened the studies and extracted the data. RESULTS: Thirteen studies were identified. The one small randomised controlled trial (RCT) found a non-significant 25% relative increase in antibiotic prescribing in the TH group. The remaining 10 were observational studies but did not control well for confounding and, therefore, were at high risk of bias. When pooled by specific infections, there was no consistent pattern. The six studies of sinusitis - including one before-after study - showed significantly less prescribing for acute rhinosinusitis in TH consultations, whereas the two studies of acute otitis media showed a significant increase. Pharyngitis, conjunctivitis, and urinary tract infections showed non-significant higher prescribing in the TH group. Bronchitis showed no change in prescribing. CONCLUSION: The impact of TH on prescribing appears to vary between conditions, with more increases than reductions. There is insufficient evidence to draw strong conclusions, however, and higher quality research is urgently needed.

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.

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 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.

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.

Common harms from amoxicillin: a systematic review and meta-analysis of randomized placebo-controlled trials for any indication.

BACKGROUND: When prescribing antibiotics for common indications, clinicians need information about both harms and benefits, information that is currently available only from observational studies. We quantified the common harms of the most frequently prescribed antibiotic, amoxicillin, from randomized placebo-controlled trials. METHODS: For this systematic review, we searched MEDLINE, Embase and the Cochrane Central Register of Controlled Trials, without language restriction, for any randomized, participant-blinded, placebo-controlled trials of amoxicillin or amoxicillin-clavulanic acid for any indication, in any setting. Our main outcome was any reported adverse event. RESULTS: Of 730 studies identified, we included 45 trials: 27 involving amoxicillin, 17 involving amoxicillin-clavulanic acid and 1 involving both. The indications for antibiotic therapy were variable. The risk of bias was low, although only 25 trials provided data suitable for assessment of harms, which suggested under-reporting. Diarrhea was attributed to amoxicillin only in the form of amoxicillin-clavulanic acid (Peto odds ratio [OR] 3.30, 95% confidence interval [CI] 2.23-4.87). The OR for candidiasis (3 trials) was significantly higher (OR 7.77, 95% CI 2.23-27.11). Rashes, nausea, itching, vomiting and abnormal results on liver function tests were not significantly increased. The results were not altered by sensitivity analyses, nor did funnel plots suggest publication bias. The number of courses of antibiotics needed to harm was 10 (95% CI 6-17) for diarrhea with amoxicillin-clavulanic acid and 27 (95% CI 24-42) for candidiasis with amoxicillin (with or without clavulanic acid). INTERPRETATION: Diarrhea was caused by use of amoxicillin-clavulanic acid, and candidiasis was caused by both amoxicillin and amoxicillin-clavulanic acid. Harms were poorly reported in most trials, and their true incidence may have been higher than reported. Nevertheless, these rates of common harms associated with amoxicillin therapy may inform decisions by helping clinicians to balance harms against benefits.

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.

Revenue effects of practice nurse-led care for chronic diseases.

OBJECTIVE: To determine the economic feasibility in Australian general practices of using a practice nurse (PN)-led care model of chronic disease management. METHODS: A cost-analysis of item numbers from the Medicare Benefit Schedule (MBS) was performed in three Australian general practices, one urban, one regional and one rural. Patients (n =254; >18 years of age) with chronic conditions (type 2 diabetes, hypertension, ischaemic heart disease) but without unstable or major health problems were randomised into usual general practitioner (GP) or PN-led care for management of their condition over a period of 12 months. After the 12-month intervention, total MBS item charges were evaluated for patients managed for their stable chronic condition by usual GP or PN-led care. Zero-skewness log transformation was applied to cost data and log-linear regression analysis was undertaken. RESULTS: There was an estimated A$129 mean increase in total MBS item charges over a 1-year period (controlled for age, self-reported quality of life and geographic location of practice) associated with PN-led care. The frequency of GP and PN visits varied markedly according to the chronic disease. CONCLUSIONS: Medicare reimbursements provided sufficient funding for general practices to employ PNs within limits of workloads before the new Practice Nurse Incentive Program was introduced in July 2012.

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.

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.