Impact of COVID-19 on accident and emergency attendances and emergency and planned hospital admissions in Scotland: an interrupted time-series analysis.

OBJECTIVES: Following the outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus and the subsequent global spread of the 2019 novel coronavirus disease (COVID-19), health systems and the populations who use them have faced unprecedented challenges. We aimed to measure the impact of COVID-19 on the uptake of hospital-based care at a national level. DESIGN: The study period (weeks ending 5 January to 28 June 2020) encompassed the pandemic announcement by the World Health Organization and the initiation of the UK lockdown. We undertook an interrupted time-series analysis to evaluate the impact of these events on hospital services at a national level and across demographics, clinical specialties and National Health Service Health Boards. SETTING: Scotland, UK. PARTICIPANTS: Patients receiving hospital care from National Health Service Scotland. MAIN OUTCOME MEASURES: Accident and emergency (A&E) attendances, and emergency and planned hospital admissions measured using the relative change of weekly counts in 2020 to the averaged counts for equivalent weeks in 2018 and 2019. RESULTS: Before the pandemic announcement, the uptake of hospital care was largely consistent with historical levels. This was followed by sharp drops in all outcomes until UK lockdown, where activity began to steadily increase. This time-period saw an average reduction of -40.7% (95% confidence interval [CI]: -47.7 to -33.7) in A&E attendances, -25.8% (95% CI: -31.1 to -20.4) in emergency hospital admissions and -60.9% (95% CI: -66.1 to -55.7) in planned hospital admissions, in comparison to the 2018-2019 averages. All subgroup trends were broadly consistent within outcomes, but with notable variations across age groups, specialties and geography. CONCLUSIONS: COVID-19 has had a profoundly disruptive impact on hospital-based care across National Health Service Scotland. This has likely led to an adverse effect on non-COVID-19-related illnesses, increasing the possibility of potentially avoidable morbidity and mortality. Further research is required to elucidate these impacts.

The effectiveness of drug round tabards in reducing incidence of medication errors.

BACKGROUND: A number of inpatients experience medication errors, which carry potential risks for patients and have cost implications for the NHS. These errors are often a result of interruptions during drug rounds. AIM: This audit study explored whether introducing drug round tabards reduced the number of interruptions during drug rounds and improved patient care and safety. METHOD: Red tabards, embroidered front and backwith "Drug round in progress please do not disturb", were introduced in three wards. A tick box questionnaire was used to collect information on interruptions during each drug round. NHS Grampian's Datix incident reporting system was reviewed for medication errors during the audit period and tabards were randomly swabbed to see if any cultures hadgrown. RESULTS AND DISCUSSION: The average number of interruptions was reduced significantly from six to five after drug round tabards were introduced and there was a slight reduction in the number of incidents reported over the five week audit period compared with the previous year. CONCLUSION: Further studies need to be conducted nationwide to provide a better understanding of the effectiveness of drug round tabards. Issues ofcost, laundering and infection control need to be further examined.

Study of progesterone for the prevention of preterm birth in twins (STOPPIT): findings from a trial-based cost-effectiveness analysis.

OBJECTIVES: Preterm birth contributes to a range of healthcare problems amongst infants surmounting to sizeable healthcare costs. Twin pregnancies are at particular risk of preterm birth. The objective of this study was to assess the cost-effectiveness of vaginal progesterone gel for the prevention of preterm birth in twin pregnancies. METHODS: An economic evaluation was conducted alongside a randomized placebo controlled trial (the STOPPIT trial) of vaginal progesterone gel for the prevention of preterm birth in twin pregnancies. Five hundred women were recruited from nine maternity hospitals in the United Kingdom. The outcomes of the economic evaluation were presented in terms of net benefit statistics, cost-effectiveness acceptability curves, generated using the nonparametric bootstrap method, and the expected value of perfect information. RESULTS: Mean health service costs between the period of randomization and discharge for mother and infant were 28,031 pound sterling in the progesterone group and 25,972 pound sterling in the placebo group, generating a mean nonsignificant cost difference of 2,059 pound sterling (bootstrap mean cost difference 2,334 pound sterling; 95 percent confidence interval: -5,023 pound sterling, 9,142 pound sterling; p = .33). The probability of progesterone being cost-effective was 20 percent at a willingness to pay threshold of 30,000 pound sterling per preterm birth prevented. There is little economic justification for conducting further research into the use of vaginal progesterone gel in twin pregnancies for the prevention of preterm birth. CONCLUSIONS: Further studies of preventive interventions for preterm birth more generally are required given the scale of the clinical and economic burden of this condition. These studies should be sufficiently powered for economic endpoints and extend beyond hospital discharge.

Topical antimicrobials in combination with admission screening and barrier precautions to control endemic methicillin-resistant Staphylococcus aureus in an Intensive Care Unit.

We aimed to establish whether screening for methicillin-resistant Staphylococcus aureus (MRSA) and body decontamination upon admission to an Intensive Care Unit (ICU), in combination with barrier precautions, reduced rates of MRSA infection acquired on the unit. This was an interrupted time series study employing segmented regression analysis of data collected for all patients admitted to a 16-bed adult ICU over 48 months. Before the intervention (24 months; 1232 patients (44% female)), MRSA was sought from clinical cultures only and positive patients were barrier nursed in isolation. During the intervention (24 months; 1421 patients (54% female)), all ICU patients were screened for MRSA on admission and were barrier nursed in single rooms when established as MRSA-positive; all were given topical nasal anti-MRSA preparations and daily bed baths with 4% chlorhexidine throughout their stay. Changes in the proportion of patients colonised or infected with MRSA in the ICU were assessed. Before the intervention, 193 new MRSA cases (16%) were identified from 1232 ICU admissions; during the intervention, this was reduced to 92 cases (6%) of 1421 admissions. By time series regression analysis, the proportion of patients with MRSA decreased by 11.38% from ca. 15% to ca. 5% (ca. three-fold reduction) (95% confidence interval 3.5-19.3%; P=0.005). Thus, treatment of 11 patients prevented 1 clinical case of MRSA. Mean length of stay decreased significantly (P<0.001). Although MRSA and methicillin-susceptible S. aureus bacteraemia rates dropped, the changes detected were not statistically significant. The proportion of patients with coagulase-negative staphylococcal bacteraemia decreased significantly (P<0.001) and the trend changed from increasing to decreasing (P<0.001), as did the trend in glycopeptide use (P=0.014). An inexpensive and easy to implement intervention to control MRSA in the ICU was highly successful without compromising antimicrobial susceptibility.

IMOP: randomised placebo controlled trial of outpatient cervical ripening with isosorbide mononitrate (IMN) prior to induction of labour - clinical trial with analyses of efficacy, cost effectiveness and acceptability.

BACKGROUND: There is increasing interest in carrying out pre-induction cervical ripening on an outpatient basis. However, there are concerns about the use of prostaglandins, the agents commonly used in hospital settings for this indication, because prostaglandins induce uterine contractions that may lead to fetal hypoxia. Indeed, in a recent study we demonstrated abnormalities in 9% of fetal heart rate tracings performed following prostaglandin induced cervical ripening at term. In contrast, we confirmed in the same study that isosorbide mononitrate (IMN) (administered on an inpatient basis) was both effective in inducing cervical ripening at term, and was associated with no associated fetal heart rate abnormalities. METHODS/DESIGN: The aim of this study is to determine whether IMN self administered by women on an outpatient basis improves the process of induction of labour. Specifically, we hypothesise that the use of outpatient IMN will result in a shorter inpatient stay before delivery, decreased costs to the health service and greater maternal satisfaction with ripening and induction of labour, compared with placebo treatment. In the study described here (the "IMOP" study), women scheduled for induction of labour at term, and who require pre-induction cervical ripening will be randomised to self-administer at home either IMN 40 mg, or a placebo, each vaginally, at 48 hours, 32 hours and 16 hours before scheduled hospital admission. After admission to hospital, treatment will revert to the usual induction of labour protocol. We will compare the primary outcomes of the elapsed time interval from hospital admission to vaginal delivery, the costs to the health service of induction of labour, and women's experience of induction of labour in the two groups. DISCUSSION: This trial will provide evidence on the efficacy of outpatient IMN for pre-induction cervical ripening at term. We will study a formulation of IMN which is cheap and widely available. If the treatment is effective, acceptable to women, and cost effective, it could be implemented into obstetric practice worldwide. TRIAL REGISTRATION: The trial has been registered on the International Standard Randomised Controlled Trial Number Register (ISRCTN) and given the registration number ISRTN39772441.

The randomized controlled trial: gold standard, or merely standard?

The randomized controlled trial (RCT) is not a gold standard: it is a good experimental design in some circumstances, but that's all. Potential shortcomings in the design and implementation of RCTs are often mentioned in passing, yet most researchers consider that RCTs are always superior to all other types of evidence. This paper examines the limitations of RCTs and shows that some types of evidence commonly supposed to be inferior to all RCTs are actually superior to many. This has important consequences for research methodology, for quality of care in clinical medicine, and--especially--for research funding policy. Because every study design may have problems in particular applications, studies should be evaluated by appropriate criteria, and not primarily according to the simplistic RCT/non-RCT dichotomy promoted by some prominent advocates of the evidence-based medicine movement and by the research evaluation guidelines based on its principles.