OBJECTIVES: Existing guideline recommendations suggest considering corticosteroids for adjunct treatment of cellulitis, but this is based on a single trial with low certainty of evidence. The objective was to determine if anti-inflammatory medication (non-steroidal anti-inflammatory drugs [NSAIDs], corticosteroids) as adjunct cellulitis treatment improves clinical response and cure. METHODS: Systematic review and meta-analysis including randomized controlled trials of patients with cellulitis treated with antibiotics irrespective of age, gender, severity and setting, and an intervention of anti-inflammatories (NSAIDs or corticosteroids) vs. placebo or no intervention. Medline (PubMed), Embase (via Elsevier), and Cochrane CENTRAL were searched from inception to August 1, 2023. Data extraction was conducted independently in pairs. Risk of bias was assessed using the Cochrane Risk of Bias Tool 2. Data were pooled using a random effects model. Primary outcomes are time to clinical response and cure. RESULTS: Five studies (n = 331) were included, all were adults. Three trials reported time to clinical response. There was a benefit with use of an oral NSAID as adjunct therapy at day 3 (risk ratio 1.81, 95%CI 1.42-2.31, I2 = 0%). There was no difference between groups at day 5 (risk ratio 1.19, 95%CI 0.62-2.26), although heterogeneity was high (I2 = 96%). Clinical cure was reported by three trials, and there was no difference between groups at all timepoints up to 22 days. Statistical heterogeneity was moderate to low. Adverse events (N = 3 trials) were infrequent. CONCLUSIONS: For patients with cellulitis, the best available data suggest that oral nonsteroidal anti-inflammatory drugs (NSAIDs) as adjunct therapy to antibiotics may lead to improved early clinical response, although this is not sustained beyond 4 days. There is insufficient data to comment on the role of corticosteroids for clinical response. These results must be interpreted with caution due to the small number of included studies. REGISTRATION: Open Science Framework: https://osf.io/vkxae?view_only=fb4f8ca438a048cb9ca83c5f47fd4d81 .
RéSUMé: OBJECTIFS: Les recommandations existantes suggèrent d'envisager des corticostéroïdes pour le traitement complémentaire de la cellulite, mais cela est basé sur un seul essai avec une faible certitude des preuves. L'objectif était de déterminer si les anti-inflammatoires (anti-inflammatoires non stéroïdiens [AINS], corticostéroïdes) comme traitement d'appoint de la cellulite améliorent la réponse clinique et la guérison. MéTHODES: Revue systématique et méta-analyse comprenant des essais contrôlés randomisés de patients atteints de cellulite traités avec des antibiotiques, indépendamment de l'âge, du sexe, de la gravité et du contexte, et une intervention d'anti-inflammatoires (AINS ou corticostéroïdes) contre placebo ou sans intervention. Medline (PubMed), Embase (via Elsevier) et Cochrane CENTRAL ont été recherchés de la création au 1er août 2023. L'extraction des données a été effectuée indépendamment par paires. Le risque de biais a été évalué à l'aide de l'outil Cochrane sur le risque de biais 2. Les données ont été regroupées à l'aide d'un modèle à effets aléatoires. Les principaux résultats sont le temps de réponse clinique et de guérison. RéSULTATS: Cinq études (n = 331) ont été incluses, toutes des études adultes. Trois essais ont indiqué le délai de réponse clinique. Il y avait un avantage avec l'utilisation d'un AINS par voie orale comme traitement d'appoint au jour 3 (risque ratio 1,81, 95%CI 1,42 à 2,31, I2 = 0%). Il n'y avait pas de différence entre les groupes au jour 5 (rapport de risque 1,19, IC à 95% 0,62 à 2,26), bien que l'hétérogénéité était élevée (I2 = 96 %). La guérison clinique a été rapportée par trois essais, et il n'y avait aucune différence entre les groupes à tous les points de temps jusqu'à 22 jours. L'hétérogénéité statistique était modérée à faible. Les événements indésirables (N = 3 essais) étaient peu fréquents. CONCLUSIONS: Pour les patients atteints de cellulite, les meilleures données disponibles suggèrent que les anti-inflammatoires non stéroïdiens oraux (AINS) comme traitement d'appoint aux antibiotiques peuvent entraîner une amélioration de la réponse clinique précoce, bien que cela ne soit pas soutenu au-delà de quatre jours. Les données sont insuffisantes pour commenter le rôle des corticostéroïdes dans la réponse clinique. Ces résultats doivent être interprétés avec prudence en raison du petit nombre d'études incluses. ENREGISTREMENT: Cadre de la science ouverte: https://osf.io/vkxae?view_only=fb4f8ca438a048cb9ca83c5f47fd4d81 .
BACKGROUND: The stages of chronic kidney disease (CKD) and estimated glomerular filtration rate (eGFR) reference ranges are currently determined without considering age. AIM: To determine whether a chart that graphs age with eGFR helps GPs make better decisions about managing patients with declining eGFR. DESIGN & SETTING: A randomised controlled vignette study among Australian GPs using a percentile chart plotting the trajectory of eGFR by age. METHOD: Three hundred and seventy-three GPs received two case studies of patients with declining renal function. They were randomised to receive the cases with the chart or without the chart, and asked a series of questions about how they would manage the cases. RESULTS: In an older female patient with stable but reduced kidney function, use of the chart was associated with GPs in the study recommending a longer follow-up period, and longer time until repeat pathology testing. In a younger male First Nations patient with normal but decreasing kidney function, use of the chart was associated with GPs in the study recommending a shorter follow-up period, shorter time to repeat pathology testing, increased management of blood pressure and lifestyle, and avoidance of nephrotoxic medications. This represents more appropriate care in both cases. CONCLUSION: Having access to a chart of percentile eGFR by age was associated with more appropriate management review periods of patients with reduced kidney function, either by greater compliance with current guidelines or greater awareness of a clinically relevant kidney problem.
Background: Of over 8,000 recorded randomised trials addressing COVID-19, around 80% were of treatments, and 17% have reported results. Approximately 1% were adaptive or platform trials, with 25 having results available, across 29 journal articles and 10 preprint articles. Methods: We conducted an extensive literature review to address four questions about COVID-19 trials, particularly the role and impact of platform/adaptive trials and lessons learned. Results: The key findings were: Q1. Social value in conducting trials and uptake into policy? COVID-19 drug treatments varied substantially and changed considerably, with drugs found effective in definitive clinical trials replacing unproven drugs. Dexamethasone has likely saved ½-2 million lives, and was cost effective across a range of countries and populations, whereas the cost effectiveness of remdesivir is uncertain. Published economic and health system impacts of COVID-19 treatments were infrequent. Q2. Issues with adaptive trial designs. Of the 77 platform trials registered, 6 major platform trials, with approximately 50 treatment arms, recruited ~135,000 participants with funding over $100 million. Q3. Models of good practice. Streamlined set-up processes such as flexible and fast-track funding, ethics, and governance approvals are vital. To facilitate recruitment, simple and streamlined research processes, and pre-existing research networks to coordinate trial planning, design, conduct and practice change are crucial to success. Q4. Potential conflicts to avoid? When treating patients through trials, balancing individual and collective rights and allocating scarce resources between healthcare and research are challenging. Tensions occur between commercial and non-commercial sectors, and academic and public health interests, such as publication and funding driven indicators and the public good. Conclusion: There is a need to (i) reduce small, repetitive, single centre trials, (ii) increase coordination to ensure robust research conducted for treatments, and (iii) a wider adoption of adaptive/platform trial designs to respond to fast-evolving evidence landscape.
BACKGROUND: Nutrition care in general practice is crucial for cardiovascular disease (CVD) prevention and management, although comparison between dietary strategies is lacking. AIM: To compare the best available (most recent, relevant, and high-quality) evidence for six dietary strategies that are effective for primary prevention/absolute risk reduction of CVD. DESIGN AND SETTING: A pragmatic narrative review of systematic reviews of randomised trials focused on primary prevention of cardiovascular events. METHOD: Studies about: 1) adults without a history of cardiovascular events; 2) target dietary strategies postulated to reduce CVD risk; and 3) direct cardiovascular or all-cause mortality outcomes were included. Six dietary strategies were examined: energy deficit, Mediterranean-like diet, sodium reduction (salt reduction and substitution), the Dietary Approaches to Stop Hypertension (DASH) diet, alcohol reduction, and fish/fish oil consumption. Reviews were selected based on quality, recency, and relevance. Quality and certainty of evidence was assessed using GRADE. RESULTS: Twenty-five reviews met inclusion criteria; eight were selected as the highest quality, recent, and relevant. Three dietary strategies showed modest, significant reductions in cardiovascular events: energy deficit (relative risk reduction [RRR] 30%, 95% confidence interval [CI] = 13 to 43), Mediterranean-like diet (RRR 40%, 95% CI = 20 to 55), and salt substitution (RRR 30%, 95% CI = 7 to 48). Still, some caveats remain on the effectiveness of these dietary strategies. Salt reduction, DASH diet, and alcohol reduction showed small, significant reductions in blood pressure, but no reduction in cardiovascular events. Fish/fish oil consumption showed little or no effect; supplementation of fish oil alone showed small reductions in CVD events. CONCLUSION: For primary prevention, energy deficit, Mediterranean-like diets, and sodium substitution have modest evidence for risk reduction of CVD events. Strategies incorporated into clinical nutrition care should ensure guidance is person centred and tailored to clinical circumstances.
BACKGROUND: Inappropriate drug prescriptions for patients with polypharmacy can have avoidable adverse consequences. We studied the effects of a clinical decision-support system (CDSS) for medication management on hospitalizations and mortality. METHODS: This stepped-wedge, cluster-randomized, controlled trial involved an open cohort of adult patients with polypharmacy in primary care practices (=clusters) in Westphalia-Lippe, Germany. During the period of the intervention, their medication lists were checked annually using the CDSS. The CDSS warns against inappropriate prescriptions on the basis of patient-related health insurance data. The combined primary endpoint consisted of overall mortality and hospitalization for any reason. The secondary endpoints were mortality, hospitalizations, and high-risk prescription. We analyzed the quarterly health insurance data of the intention-to-treat population with a mixed logistic model taking account of clustering and repeated measurements. Sensitivity analyses addressed effects of the COVID-19 pandemic and other effects. RESULTS: 688 primary care practices were randomized, and data were obtained on 42 700 patients over 391 994 quarter years. No significant reduction was found in either the primary endpoint (odds ratio [OR] 1.00; 95% confidence interval [0.95; 1.04]; p = 0.8716) or the secondary endpoints (hospitalizations: OR 1.00 [0.95; 1.05]; mortality: OR 1.04 [0.92; 1.17]; high-risk prescription: OR 0.98 [0.92; 1.04]). CONCLUSION: The planned analyses did not reveal any significant effect of the intervention. Pandemic-adjusted analyses yielded evidence that the mortality of adult patients with polypharmacy might potentially be lowered by the CDSS. Controlled trials with appropriate follow-up are needed to prove that a CDSS has significant effects on mortality in patients with polypharmacy.
Cardiovascular Diseases , Diabetes, Gestational , Pregnancy Complications, Cardiovascular , Female , Humans , Pregnancy , Cardiovascular System , Diabetes, Gestational/epidemiology , Heart , Mediastinum , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/etiology , Pregnancy Complications, Cardiovascular/epidemiology , Pregnancy Complications, Cardiovascular/etiology
BACKGROUND: Many guidelines recommend non-drug interventions (NDIs) for managing common conditions in primary care. However, compared with drug interventions, NDIs are less widely known, promoted and used. We aim to (1) examine general practitioners' (GPs') knowledge, attitudes and practices for NDIs, including their use of the Royal Australian College of General Practitioners (RACGP) Handbook of Non-Drug Interventions (HANDI), and (2) identify factors influencing their use of NDIs and HANDI. METHODS: We conducted a web-based cross-sectional survey of practicing GP members in Australia during October-November 2022. The survey contained five sections: characteristics of GP; knowledge and use of NDIs; attitudes towards NDIs; barriers and enablers to using HANDI; and suggestions of NDIs and ideas to improve the uptake of NDIs in primary care. RESULTS: Of the 366 GPs who completed the survey, 242 (66%) were female, and 248 (74%) were ≥45 years old. One in three GPs reported that they regularly ('always') recommend NDIs to their patients when appropriate (34%), whereas one-third of GPs were unaware of HANDI (39%). GPs identified several factors that improve the uptake of HANDI, including 'access and integration of HANDI in clinical practice', 'content and support to use in practice' and 'awareness and training'. CONCLUSIONS: While many GPs are aware of the effectiveness of NDIs and often endorse their use, obstacles still prevent widespread adoption in primary care. The results of this survey can serve as a foundation for developing implementation strategies to improve the uptake of effective evidence-based NDIs in primary care.
General Practitioners , Humans , Female , Middle Aged , Male , Cross-Sectional Studies , Australia , Biological Transport , Evidence-Based Medicine
BACKGROUND AND AIMS: Knowledge of quantifiable cardiovascular disease (CVD) risk may improve health outcomes and trigger behavioural change in patients or clinicians. This review aimed to investigate the impact of CVD risk communication on patient-perceived CVD risk and changes in CVD risk factors. METHODS: PubMed, Embase, and PsycINFO databases were searched from inception to 6 June 2023, supplemented by citation analysis. Randomized trials that compared any CVD risk communication strategy versus usual care were included. Paired reviewers independently screened the identified records and extracted the data; disagreements were resolved by a third author. The primary outcome was the accuracy of risk perception. Secondary outcomes were clinician-reported changes in CVD risk, psychological responses, intention to modify lifestyle, and self-reported changes in risk factors and clinician prescribing of preventive medicines. RESULTS: Sixty-two trials were included. Accuracy of risk perception was higher among intervention participants (odds ratio = 2.31, 95% confidence interval = 1.63 to 3.27). A statistically significant improvement in overall CVD risk scores was found at 6-12 months (mean difference = -0.27, 95% confidence interval = -0.45 to -0.09). For primary prevention, risk communication significantly increased self-reported dietary modification (odds ratio = 1.50, 95% confidence interval = 1.21 to 1.86) with no increase in intention or actual changes in smoking cessation or physical activity. A significant impact on patients' intention to start preventive medication was found for primary and secondary prevention, with changes at follow-up for the primary prevention group. CONCLUSIONS: In this systematic review and meta-analysis, communicating CVD risk information, regardless of the method, reduced the overall risk factors and enhanced patients' self-perceived risk. Communication of CVD risk to patients should be considered in routine consultations.
Cardiovascular Diseases , Smoking Cessation , Humans , Cardiovascular Diseases/prevention & control , Risk Factors , Communication , Exercise , Primary Prevention/methods
OBJECTIVE: To assess and compare the diagnostic performance of Clinical Prediction Rules (CPRs) developed to detect group A Beta-haemolytic streptococci in people with acute pharyngitis (or sore throat). STUDY DESIGN: A systematic review. METHODS: We searched PubMed, Embase and Web of Science (inception-September 2022) for studies deriving and/or validating CPRs comprised of ≥2 predictors from an individual's history or physical examination. Two authors independently screened articles, extracted data and assessed risk of bias in included studies. A meta-analysis was not possible due to heterogeneity. Instead we compared the performance of CPRs when they were validated in the same study population (head-to-head comparisons). We used a modified grading of recommendations, assessment, development, and evaluations (GRADE) approach to assess certainty of the evidence. RESULTS: We included 63 studies, all judged at high risk of bias. Of 24 derived CPRs, 7 were externally validated (in 46 external validations). Five validation studies provided data for head-to-head comparison of four pairs of CPRs. Very low certainty evidence favoured the Centor CPR over the McIsaac (2 studies) and FeverPain CPRs (1 study) and found the Centor CPR was equivalent to the Walsh CPR (1 study). The AbuReesh and Steinhoff 2005 CPRs had a similar poor discriminative ability (1 study). Within and between study comparisons suggested the performance of the Centor CPR may be better in adults (>18 years). CONCLUSION: Very low certainty evidence suggests a better performance of the Centor CPR. When deciding about antibiotic prescribing for pharyngitis patients, involving patients in a shared decision making discussion about the likely benefits and harms, including antibiotic resistance, is recommended. Further research of higher rigour, which compares CPRs across multiple settings, is needed.
Clinical Decision Rules , Pharyngitis , Adult , Humans , Pharyngitis/diagnosis , Bias , Anti-Bacterial Agents/therapeutic use , Physical Examination
OBJECTIVE: To identify healthcare professionals' knowledge, self-reported use, and documentation of clinical decision aids (CDAs) in a large ED in Australia, to identify behavioural determinants influencing the use of CDAs, and healthcare professionals preferences for integrating CDAs into the electronic medical record (EMR) system. METHODS: Healthcare professionals (doctors, nurses and physiotherapists) working in the ED at the Gold Coast Hospital, Queensland were invited to complete an online survey. Quantitative data were analysed using descriptive statistics, and where appropriate, mapped to the theoretical domains framework to identify potential barriers to the use of CDAs. Qualitative data were analysed using content analysis. RESULTS: Seventy-four healthcare professionals (34 medical officers, 31 nurses and nine physiotherapists) completed the survey. Healthcare professionals' knowledge and self-reported use of 21 validated CDAs was low but differed considerably across CDAs. Only 4 out of 21 CDAs were reported to be used 'sometimes' or 'always' by the majority of respondents (Ottawa Ankle Rule for ankle injury, Wells' criteria for pulmonary embolism, Wells' criteria for deep vein thrombosis and PERC rule for pulmonary embolism). Most respondents wanted to increase their use of valid and reliable CDAs and supported the integration of CDAs into the EMR to facilitate their use and support documentation. Potential barriers impacting the use of CDAs represented three theoretical domains of knowledge, social/professional role and identity, and social influences. CONCLUSIONS: CDAs are used variably by healthcare professionals and are inconsistently applied in the clinical encounter. Preferences of healthcare professionals need to be considered to allow the successful integration of CDAs into the EMR.
Physical Therapists , Pulmonary Embolism , Humans , Cross-Sectional Studies , Australia , Emergency Service, Hospital , Decision Support Techniques
OBJECTIVES: To evaluate the strength of the evidence for, and the extent of, overdiagnosis in noncancer conditions. STUDY DESIGN AND SETTING: We systematically searched for studies investigating overdiagnosis in noncancer conditions. Using the 'Fair Umpire' framework to assess the evidence that cases diagnosed by one diagnostic strategy but not by another may be overdiagnosed, two reviewers independently identified whether a Fair Umpire-a disease-specific clinical outcome, a test result or risk factor that can determine whether an additional case does or does not have disease-was present. Disease-specific clinical outcomes provide the strongest evidence for overdiagnosis, follow-up or concurrent tests provide weaker evidence, and risk factors provide only weak evidence. Studies without a Fair Umpire provide the weakest evidence of overdiagnosis. RESULTS: Of 132 studies, 47 (36%) did not include a Fair Umpire to adjudicate additional diagnoses. When present, the most common Umpire was a single test or risk factor (32% of studies), with disease-specific clinical outcome Umpires used in only 21% of studies. Estimates of overdiagnosis included 43-45% of screen-detected acute abdominal aneurysms, 54% of cases of acute kidney injury, and 77% of cases of oligohydramnios in pregnancy. CONCLUSION: Much of the current evidence for overdiagnosis in noncancer conditions is weak. Application of the framework can guide development of robust studies to detect and estimate overdiagnosis in noncancer conditions, ultimately informing evidence-based policies to reduce it.
Medical Overuse , Overdiagnosis , Female , Pregnancy , Humans , Risk Factors
OBJECTIVE: To assess the replicability of a 2-week systematic review (index 2weekSR) created with the assistance of automation tools using the fidelity method. METHODS: A Preferred Reporting Items for Systematic reviews and Meta-Analyses compliant SR protocol was developed based on the published information of the index 2weekSR study. The replication team consisted of three reviewers. Two reviewers blocked off time during the replication. The total time to complete tasks and the meta-analysis results were compared with the index 2weekSR study. Review process fidelity scores (FSs) were calculated for review methods and outcomes. Barriers to completing the replication were identified. RESULTS: The review was completed over 63 person-hours (11 workdays/15 calendar days). A FS of 0.95 was achieved for the methods, with 3 (of 8) tasks only partially replicated, and an FS of 0.63 for the outcomes, with 6 (of 7) only partially replicated and one task was not replicated. Nonreplication was mainly caused by missing information in the index 2weekSR study that was not required in standard reporting guidelines. The replication arrived at the same conclusions as the original study. CONCLUSION: A 2weekSR study was replicated by a small team of three reviewers supported by automation tools. Including additional information when reporting SRs should improve their replicability.
BACKGROUND: Acute otitis media (AOM) is one of the most common diseases in childhood for which antibiotics are commonly prescribed; a systematic review reported a pooled prevalence of 85.6% in high-income countries. This is an update of a Cochrane Review first published in the Cochrane Library in 1997 and updated in 1999, 2005, 2009, 2013 and 2015. OBJECTIVES: To assess the effects of antibiotics for children with AOM. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, Current Contents, CINAHL, LILACS and two trial registers. The date of the search was 14 February 2023. SELECTION CRITERIA: We included randomised controlled trials comparing 1) antimicrobial drugs with placebo, and 2) immediate antibiotic treatment with expectant observation (including delayed antibiotic prescribing) in children with AOM. DATA COLLECTION AND ANALYSIS: Two review authors independently screened trials for inclusion and extracted data using the standard methodological procedures recommended by Cochrane. Our primary outcomes were: 1) pain at various time points (24 hours, two to three days, four to seven days, 10 to 14 days), and 2) adverse effects likely to be related to the use of antibiotics. Secondary outcomes were: 1) abnormal tympanometry findings, 2) tympanic membrane perforation, 3) contralateral otitis (in unilateral cases), 4) AOM recurrences, 5) serious complications related to AOM and 6) long-term effects (including the number of parent-reported AOM symptom episodes, antibiotic prescriptions and health care utilisation as assessed at least one year after randomisation). We used the GRADE approach to rate the overall certainty of evidence for each outcome of interest. MAIN RESULTS: Antibiotics versus placebo We included 13 trials (3401 children and 3938 AOM episodes) from high-income countries, which we assessed at generally low risk of bias. Antibiotics do not reduce pain at 24 hours (risk ratio (RR) 0.89, 95% confidence interval (CI) 0.78 to 1.01; 5 trials, 1394 children; high-certainty evidence), or at four to seven days (RR 0.76, 95% CI 0.50 to 1.14; 7 trials, 1264 children), but result in almost a third fewer children having pain at two to three days (RR 0.71, 95% CI 0.58 to 0.88; number needed to treat for an additional beneficial outcome (NNTB) 20; 7 trials, 2320 children; high-certainty evidence), and likely result in two-thirds fewer having pain at 10 to 12 days (RR 0.33, 95% CI 0.17 to 0.66; NNTB 7; 1 trial, 278 children; moderate-certainty evidence). Antibiotics increase the risk of adverse events such as vomiting, diarrhoea or rash (RR 1.38, 95% CI 1.16 to 1.63; number needed to treat for an additional harmful outcome (NNTH) 14; 8 trials, 2107 children; high-certainty evidence). Antibiotics reduce the risk of children having abnormal tympanometry findings at two to four weeks (RR 0.83, 95% CI 0.72 to 0.96; NNTB 11; 7 trials, 2138 children), slightly reduce the risk of experiencing tympanic membrane perforations (RR 0.43, 95% CI 0.21 to 0.89; NNTB 33; 5 trials, 1075 children) and halve the risk of contralateral otitis episodes (RR 0.49, 95% CI 0.25 to 0.95; NNTB 11; 4 trials, 906 children). However, antibiotics do not reduce the risk of abnormal tympanometry findings at six to eight weeks (RR 0.89, 95% CI 0.70 to 1.13; 3 trials, 953 children) and at three months (RR 0.94, 95% CI 0.66 to 1.34; 3 trials, 809 children) or late AOM recurrences (RR 0.94, 95% CI 0.79 to 1.11; 6 trials, 2200 children). Severe complications were rare, and the evidence suggests that serious complications do not differ between children treated with either antibiotics or placebo. Immediate antibiotics versus expectant observation We included six trials (1556 children) from high-income countries. The evidence suggests that immediate antibiotics may result in a reduction of pain at two to three days (RR 0.53, 95% CI 0.35 to 0.79; NNTB 8; 1 trial, 396 children; low-certainty evidence), but probably do not reduce the risk of pain at three to seven days (RR 0.75, 95% CI 0.50 to 1.12; 4 trials, 959 children; moderate-certainty evidence), and may not reduce the risk of pain at 11 to 14 days (RR 0.91, 95% CI 0.75 to 1.10; 1 trial, 247 children; low-certainty evidence). Immediate antibiotics increase the risk of vomiting, diarrhoea or rash (RR 1.87, 95% CI 1.39 to 2.51; NNTH 10; 3 trials, 946 children; high-certainty evidence). Immediate antibiotics probably do not reduce the proportion of children with abnormal tympanometry findings at four weeks and evidence suggests that immediate antibiotics may not reduce the risk of tympanic membrane perforation and AOM recurrences. No serious complications occurred in either group. AUTHORS' CONCLUSIONS: This review reveals that antibiotics probably have no effect on pain at 24 hours, a slight effect on pain in the days following and only a modest effect on the number of children with tympanic perforations, contralateral otitis episodes and abnormal tympanometry findings at two to four weeks compared with placebo in children with AOM. In high-income countries, most cases of AOM spontaneously remit without complications. The benefits of antibiotics must be weighed against the possible harms: for every 14 children treated with antibiotics, one child experienced an adverse event (such as vomiting, diarrhoea or rash) that would not have occurred if antibiotics were withheld. For most children with mild disease in high-income countries, an expectant observational approach seems justified. Therefore, clinical management should emphasise advice about adequate analgesia and the limited role for antibiotics.
Exanthema , Otitis Media , Tympanic Membrane Perforation , Child , Humans , Anti-Bacterial Agents/adverse effects , Tympanic Membrane Perforation/drug therapy , Tympanic Membrane Perforation/chemically induced , Acute Disease , Otitis Media/drug therapy , Otitis Media/epidemiology , Pain/drug therapy , Diarrhea/chemically induced , Vomiting/chemically induced
BACKGROUND: Telehealth has been used for health care delivery for decades, but the COVID-19 pandemic greatly accelerated the uptake of telehealth in many care settings globally. However, few studies have carried out a direct comparison among different telehealth modalities, with very few studies having compared the effectiveness of telephone and video telehealth modalities. OBJECTIVE: This study aimed to identify and synthesize randomized controlled trials (RCTs) comparing synchronous telehealth consultations delivered by telephone and those conducted by video with outcomes such as clinical effectiveness, patient safety, cost-effectiveness, and patient and clinician satisfaction with care. METHODS: PubMed (MEDLINE), Embase, and CENTRAL were searched via the Cochrane Library from inception until February 10, 2023, for RCTs without any language restriction. Forward and backward citation searches were conducted on included RCTs. The Cochrane Risk of Bias 2 tool was used to assess the quality of the studies. We included studies carried out in any health setting-involving all types of outpatient cohorts and all types of health care providers-that compared synchronous video consultations directly with telephone consultations and reported outcomes specified in the objective. We excluded studies of clinician-to-clinician telehealth consults, hospitalized patients, and asynchronous consultations. RESULTS: Sixteen RCTs-10 in the United States, 3 in the United Kingdom, 2 in Canada, and 1 in Australia involving 1719 participants-were included in the qualitative and quantitative analyses. Most of the telehealth interventions were for hospital-based outpatient follow-ups, monitoring, and rehabilitation (n=13). The 3 studies that were conducted in the community all focused on smoking cessation. In half of the studies, nurses delivered the care (n=8). Almost all included studies had high or unclear risk of bias, mainly due to bias in the randomization process and selection of reported results. The trials found no substantial differences between telephone and video telehealth consultations with regard to clinical effectiveness, patient satisfaction, and health care use (cost-effectiveness) outcomes. None of the studies reported on patient safety or adverse events. We did not find any study on telehealth interventions for diagnosis, initiating new treatment, or those conducted in a primary care setting. CONCLUSIONS: Based on a small set of diverse trials, we found no notable differences between telephone and video consultations for the management of patients with an established diagnosis. There is also a significant lack of telehealth research in primary care settings despite its high uptake.
Telemedicine , Telephone , Humans , Telemedicine/methods , Personal Satisfaction , Australia , Canada , Randomized Controlled Trials as Topic
