Evidence-practice gaps for Australian General Practitioners (GP) in assisting pregnant women to quit

Background: Smoking prevalence among Indigenous pregnant women is high at 49%. Evidence-based smoking cessation interventions have not been effectively translated into the maternal Indigenous context. Aims: To explore GPs' knowledge, attitudes and practices of managing smoking in pregnant women. Methods: A random sample of 500 members of the RACGP National Faculty of Aboriginal and Torres Strait Islander Health were invited to an on-line survey. Inclusion criteria were GPs who consult with pregnant women. The response rate was low at 8% (N = 42), however alternative recruitment is ongoing. Results: One-third of the sample worked in Indigenous organisations; 62% of respondents were women. Most GPs (81%) always asked and gave brief advice about smoking in pregnancy. Less GPs (62%) always provided cessation support, assessed dependence (55%), discussed the psychosocial context of smoking (33%), followed up within 2 weeks (14%); 5% referred to the Quitline. Only 21% always recommended/prescribed nicotine replacement therapy (NRT), despite 93% agreeing that using NRT in pregnancy was safer than smoking; 71% believed NRT was moderately effective, and 69% were confident to prescribe NRT. More GPs in Indigenous organisations, compared to mainstream, agreed that discussing smoking benefits their relationship with pregnant clients (p < 0.05). Discussing psychosocial contexts was positively associated with prescribing NRT (p < 0.05). Only 10% GPs trained in smoking cessation for pregnancy; 83% agreed training was warranted, over two-thirds agreed access to oral NRT should be improved. Conclusions: Smoking cessation is a high priority for cancer prevention. NRT can be offered to pregnant smokers unable to quit. Low levels of assisted quitting may relate to scarcity of training for pregnancy, and policies governing access. Caution is advised due to small sample size. Translational research aspect: Training GPs in smoking cessation for pregnant women, and improving NRT access, may progress T2/3 translation of evidence-based methods for smokers in high prevalence groups

Red-flag sepsis and SOFA identifies different patient population at risk of sepsis-related deaths on the general ward

Controversy exists regarding the best diagnostic and screening tool for sepsis outside the intensive care unit (ICU). Sequential organ failure assessment (SOFA) score has been shown to be superior to systemic inflammatory response syndrome (SIRS) criteria, however, the performance of “Red Flag sepsis criteria” has not been tested formally. The aim of the study was to investigate the ability of Red Flag sepsis criteria to identify the patients at high risk of sepsis-related death in comparison to SOFA based sepsis criteria. We also investigated the comparison of Red Flag sepsis to quick SOFA (qSOFA), SIRS, and national early warning score (NEWS) scores and factors influencing patient mortality. Patients were recruited into a 24-hour point-prevalence study on the general wards and emergency departments across all Welsh acute hospitals. Inclusion criteria were: clinical suspicion of infection and NEWS 3 or above in-line with established escalation criteria in Wales. Data on Red Flag sepsis and SOFA criteria was collected together with qSOFA and SIRS scores and 90-day mortality. 459 patients were recruited over a 24-hour period. 246 were positive for Red Flag sepsis, mortality 33.7% (83/246); 241 for SOFA based sepsis criteria, mortality 39.4% (95/241); 54 for qSOFA, mortality 57.4% (31/54), and 268 for SIRS, mortality 33.6% (90/268). 55 patients were not picked up by any criteria. We found that older age was associated with death with OR (95% CI) of 1.03 (1.02–1.04); higher frailty score 1.24 (1.11–1.40); DNA-CPR order 1.74 (1.14–2.65); ceiling of care 1.55 (1.02–2.33); and SOFA score of 2 and above 1.69 (1.16–2.47). The different clinical tools captured different subsets of the at-risk population, with similar sensitivity. SOFA score 2 or above was independently associated with increased risk of death at 90 days. The sequalae of infection-related organ dysfunction cannot be reliably captured based on routine clinical and physiological parameters alone

Sepsis-related deaths in the at-risk population on the wards: attributable fraction of mortality in a large point-prevalence study

Objective Sepsis mortality is reported to be high worldwide, however recently the attributable fraction of mortality due to sepsis (AFsepsis) has been questioned. If improvements in treatment options are to be evaluated, it is important to know what proportion of deaths are potentially preventable or modifiable after a sepsis episode. The aim of the study was to establish the fraction of deaths directly related to the sepsis episode on the general wards and emergency departments. Results 839 patients were recruited over the two 24-h periods in 2016 and 2017. 521 patients fulfilled SEPSIS-3 criteria. 166 patients (32.4%) with sepsis and 56 patients (17.6%) without sepsis died within 90 days. Out of the 166 sepsis deaths 12 (7.2%) could have been directly related to sepsis, 28 (16.9%) possibly related and 96 (57.8%) were not related to sepsis. Overall AFsepsis was 24.1%. Upon analysis of the 40 deaths likely to be attributable to sepsis, we found that 31 patients (77.5%) had the Clinical Frailty Score ≥ 6, 28 (70%) had existing DNA-CPR order and 17 had limitations of care orders (42.5%)

Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial

SummaryBackground Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatoryactions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19.Methods In this randomised, controlled, open-label, adaptive platform trial (Randomised Evaluation of COVID-19Therapy [RECOVERY]), several possible treatments were compared with usual care in patients admitted to hospitalwith COVID-19 in the UK. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients wererandomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once perday by mouth or intravenously for 10 days or until discharge (or allocation to one of the other RECOVERY treatmentgroups). Patients were assigned via web-based simple (unstratified) randomisation with allocation concealment andwere twice as likely to be randomly assigned to usual care than to any of the active treatment groups. Participants andlocal study staff were not masked to the allocated treatment, but all others involved in the trial were masked to theoutcome data during the trial. The primary outcome was 28-day all-cause mortality, assessed in the intention-to-treatpopulation. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.Findings Between April 7 and Nov 27, 2020, of 16 442 patients enrolled in the RECOVERY trial, 9433 (57%) wereeligible and 7763 were included in the assessment of azithromycin. The mean age of these study participants was65·3 years (SD 15·7) and approximately a third were women (2944 [38%] of 7763). 2582 patients were randomlyallocated to receive azithromycin and 5181 patients were randomly allocated to usual care alone. Overall,561 (22%) patients allocated to azithromycin and 1162 (22%) patients allocated to usual care died within 28 days(rate ratio 0·97, 95% CI 0·87–1·07; p=0·50). No significant difference was seen in duration of hospital stay (median10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days(rate ratio 1·04, 95% CI 0·98–1·10; p=0·19). Among those not on invasive mechanical ventilation at baseline, nosignificant difference was seen in the proportion meeting the composite endpoint of invasive mechanical ventilationor death (risk ratio 0·95, 95% CI 0·87–1·03; p=0·24).Interpretation In patients admitted to hospital with COVID-19, azithromycin did not improve survival or otherprespecified clinical outcomes. Azithromycin use in patients admitted to hospital with COVID-19 should be restrictedto patients in whom there is a clear antimicrobial indication

Opportunities missed: a cross-sectional survey of the provision of smoking cessation care to pregnant women by Australian general practitioners and obstetricians

Introduction: Similar to other high-income countries, smoking rates in pregnancy can be high in specific vulnerable groups in Australia. Several clinical guidelines exist, including the 5A’s (Ask, Advice, Assess, Assist, and Arrange), ABCD (Ask, Brief advice, Cessation, and Discuss), and AAR (Ask, Advice, and Refer). There is lack of data on provision of smoking cessation care (SCC) of Australian General Practitioners (GPs) and Obstetricians. Methods: A cross-sectional survey explored the provision of SCC, barriers and enablers using the Theoretical Domains Framework, and the associations between them. Two samples were invited: (1) GPs and Obstetricians from a college database (n = 5571); (2) GPs from a special interest group for Indigenous health (n = 500). Dimension reduction for the Theoretical Domains Framework was achieved with factor analysis. Logistic regression was carried out for performing all the 5A’s and the AAR. Results: Performing all of the 5A’s, ABCD, and AAR “often and always” was reported by 19.9%, 15.6%, and 49.2% respectively. “Internal influences” (such as confidence in counselling) were associated with higher performance of the 5A’s (Adjusted OR 2.69 (95% CI 1.5, 4.8), p < .001), whereas “External influences” (such as workplace routine) were associated with higher performance of AAR (Adjusted OR 1.7 (95% CI 1, 2.8), p = .035). Conclusions: Performance in providing SCC to pregnant women is low among Australian GPs and Obstetricians. Training clinicians should focus on improving internal influences such as confidence and optimism. The AAR may be easier to implement, and interventions at the service level should focus on ensuring easy, effective, and acceptable referral mechanisms are in place. Implications: Improving provision of the 5A’s approach should focus on the individual level, including better training for GPs and Obstetricians, designed to improve specific “internal” barriers such as confidence in counselling and optimism. The AAR may be easier to implement in view of the higher overall performance of this approach. Interventions on a more systemic level need to ensure easy, effective, and acceptable referral mechanisms are in place. More research is needed specifically on the acceptability of the Quitline for pregnant women, both Indigenous and non-Indigenous

Improving smoking cessation care in pregnancy at Aboriginal Medical Services : 'ICAN QUIT in Pregnancy' step-wedge cluster randomised study

Objectives: This study aimed to examine the impact of the ‘ICAN QUIT in Pregnancy’ intervention on individual health providers (HPs) smoking cessation care (SCC) knowledge, attitudes and practices in general, and specifically regarding nicotine replacement therapy (NRT) prescription. Design: Step-wedge clustered randomised controlled study. HPs answered a preintervention and 1–6 months postintervention survey. Setting: Six Aboriginal Medical Services (AMSs) in three states of Australia. Participants: All HPs were invited to participate. Of 93 eligible, 50 consented (54%), 45 completed the presurvey (90%) and 20 the post (40%). Intervention: Included three 1-hour webinar sessions, educational resource package and free oral NRT. Outcomes: HPs knowledge was measured using two composite scores—one from all 24 true/false statements, and one from 12 NRT-specific statements. Self-assessment of 22 attitudes to providing SCC were measured using a five-point Likert scale (Strongly disagree to Strongly agree). Two composite mean scores were calculated—one for 15 general SCC attitudes, and one for 7 NRT-specific attitudes. Self-reported provision of SCC components was measured on a five-point Likert scale (Never to Always). Feasibility outcomes, and data collected on the service and patient level are reported elsewhere. Results: Mean knowledge composite scores improved from pre to post (78% vs 84% correct, difference 5.95, 95% CI 1.57 to 10.32). Mean NRT-specific knowledge composite score also improved (68% vs 79% correct, difference 9.9, 95% CI 3.66 to 16.14). Mean attitude composite score improved (3.65 (SD 0.4) to 3.87 (SD 0.4), difference 0.23, 95% CI 0.05 to 0.41). Mean NRT-specific attitudes composite score also improved (3.37 (SD 0.6) to 3.64 (SD 0.7), difference 0.36, 95% CI 0.13 to 0.6). Self-reported practices were unchanged, including prescribing NRT. Conclusions: A multicomponent culturally sensitive intervention in AMSs was feasible, and might improve HPs provision of SCC to pregnant Aboriginal women. Changes in NRT prescription rates may require additional intensive measures

The MOHMQuit (Midwives and Obstetricians Helping Mothers to Quit Smoking) Trial: protocol for a stepped-wedge implementation trial to improve best practice smoking cessation support in public antenatal care services

Background: Smoking during pregnancy is the most important preventable cause of adverse pregnancy outcomes, yet smoking cessation support (SCS) is inconsistently provided. The MOMHQUIT intervention was developed to address this evidence-practice gap, using the Behaviour Change Wheel method by mapping barriers to intervention strategies. MOHMQuit includes systems, leadership and clinician elements. This implementation trial will determine the effectiveness and cost-effectiveness of MOHMQuit in improving smoking cessation rates in pregnant women in public maternity care services in Australia; test the mechanisms of action of the intervention strategies; and examine implementation outcomes. Methods: A stepped-wedge cluster-randomised design will be used. Implementation of MOHMQuit will include reinforcing leadership investment in SCS as a clinical priority, strengthening maternity care clinicians’ knowledge, skills, confidence and attitudes towards the provision of SCS, and clinicians’ documentation of guideline-recommended SCS provided during antenatal care. Approximately, 4000 women who report smoking during pregnancy will be recruited across nine sites. The intervention and its implementation will be evaluated using a mixed methods approach. The primary outcome will be 7-day point prevalence abstinence at the end of pregnancy, among pregnant smokers, verified by salivary cotinine testing. Continuous data collection from electronic medical records and telephone interviews with postpartum women will occur throughout 32 months of the trial to assess changes in cessation rates reported by women, and SCS documented by clinicians and reported by women. Data collection to assess changes in clinicians’ knowledge, skills, confidence and attitudes will occur prior to and immediately after the intervention at each site, and again 6 months later. Questionnaires at 3 months following the intervention, and semi-structured interviews at 6 months with maternity service leaders will explore leaders’ perceptions of acceptability, adoption, appropriateness, feasibility, adaptations and fidelity of delivery of the MOHMQuit intervention. Structural equation modelling will examine causal linkages between the strategies, mediators and outcomes. Cost-effectiveness analyses will also be undertaken. Discussion: This study will provide evidence of the effectiveness of a multi-level implementation intervention to support policy decisions; and evidence regarding mechanisms of action of the intervention strategies (how the strategies effected outcomes) to support further theoretical developments in implementation science. Trial registration: ACTRN12622000167763, registered February 2nd 2022