Evaluating the impact of healthcare interventions using routine data

Clarke, Geraldine M.; Conti, Stefano; Wolters, Arne; Steventon, Adam

doi:10.1136/bmj.l2239

Cited by 80 publications

(67 citation statements)

References 39 publications

(29 reference statements)

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“…The practice of having an additional midwife present during the active phase of the second stage of labour may be a non-invasive strategy compared to other preventive interventions [ 27 ]. However, adding another midwife in the birthing room can be viewed as a complex health care intervention [ 28 ] which may have negative side effects or unintended consequences. The maternity wards that have employed the method have not increased the numbers of midwives.…”

Section: Discussionmentioning

confidence: 99%

One Plus One Equals Two—will that do? A trial protocol for a Swedish multicentre randomised controlled trial to evaluate a clinical practice to reduce severe perineal trauma

Edqvist

Dahlen

Häggsgård

et al. 2020

Trials

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Background Severe perineal trauma sustained during childbirth is a serious complication since it can lead to both short- and long-term consequences for women. Some of the methods used to prevent perineal injuries have been evaluated in clinical trials, but there are still gaps in the evidence. A new clinical practice has been introduced, adopted by more than half of the maternity wards in Sweden with the aim of reducing severe perineal trauma. This procedure involves two midwives assisting the woman during the second stage of labour. Methods/design In this multicentre randomised controlled trial, 2946 women will be randomised to be assisted by one or two midwives during the second stage of labour. Women age 18–47, who plan for their first vaginal birth, with a singleton pregnancy in cephalic presentation, will be asked to participate when admitted to the maternity ward. Five maternity wards comprising 19,500 births/year in different parts of Sweden will participate in this study. The sample size is powered to demonstrate a 50% reduction (from 4.1–2.0%) in primary outcome, which is the prevalence of severe perineal trauma (3rd and 4th degree). Secondary outcomes will include maternal and neonatal outcomes, women’s experiences, midwives’ experiences of the intervention, incontinence, and pelvic floor symptoms. The primary analysis is intention to treat. Questionnaires will be sent to the women at 1 month and 1 year after the birth to assess women’s experiences, pain, incontinence, pelvic floor symptoms, sexual function, and mental health. Discussion It is important for care during labour and birth to be evidence based. There is a strong desire among midwives to reduce the risk of severe perineal trauma. This may lead to new strategies and practices being implemented into practice without scientific evidence. The intervention might have negative side effects or unintended consequences. On the other hand, there is a possibility of the intervention improving care for women. Trial registration {2a} ClinicalTrials.gov NCT03770962. Registered on 10 December 2018

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Section: Discussionmentioning

confidence: 99%

One Plus One Equals Two—will that do? A trial protocol for a Swedish multicentre randomised controlled trial to evaluate a clinical practice to reduce severe perineal trauma

Edqvist

Dahlen

Häggsgård

et al. 2020

Trials

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“…While simple audits have been useful in assessing adherence to guidelines,30 they have their limitations. A recent review of assessing the impact of healthcare interventions using routine data by Clarke et al 31 outlines these points. We demonstrate the utility of the PDSA model to improve clinical care in DKA management.…”

Section: Resultsmentioning

confidence: 99%

Regular performance feedback may be key to maintain good quality DKA management: results from a five-year study

Kempegowda

Chandan

Coombs

et al. 2019

BMJ Open Diab Res Care

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ObjectivesWe postulate that performance feedback is a prerequisite to ensure sustained improvement in diabetic ketoacidosis (DKA) management.DesignThe study was based on ‘theory of change’ concept that suggests changes of primary drivers determine the main outcome. A set of secondary drivers can be implemented to achieve improvements in these primary drivers and thus the main outcome.SettingThis study was conducted at a large tertiary care center in the West Midlands, UK. The region has above average prevalence of diabetes and DKA admissions in the country.ParticipantsAll participants diagnosed with DKA as per national guidelines, except those managed in intensive care unit from April 2014 to March 2018, were included in this study.InterventionsMonthly feedback of performance was the main intervention. Development of a real-time live DKA audit tool, automatic referral system of DKA to the specialist team, electronic monitoring of blood gas measurements and education and redesigning of local (trust) guidelines were the other interventions in this study.Main outcome measuresTotal DKA duration, appropriateness of fixed rate intravenous insulin infusion, fluid prescription, glucose monitoring, ketone monitoring and referral to specialists.ResultsThere was a significant reduction in the duration of DKA postintervention compared with baseline results. However, in the absence of regular feedback, the duration of DKA showed an upward trend nearing baseline values. Similar trends were noted in secondary drivers influencing DKA duration.ConclusionBased on these results, we recommend regular audit and feedback is required to sustain improvements in DKA management.

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“…Of greater concern would be the presence of bias, in which hospital behaviour about coding accuracy of inpatient comorbidities or complications would change between study groups and periods. 32 Because that information is critical for billing purposes, inpatient deaths, intensive care stays, and reoperations are accurately collected in hospitals claims databases. This is not necessarily the case for identifying specific adverse events based on diagnoses codes, the validity of which is debatable and might explain the absence of differences observed for severe complications between hospitals groups.…”

Section: Discussionmentioning

confidence: 99%

Effect of monitoring surgical outcomes using control charts to reduce major adverse events in patients: cluster randomised trial

Duclos

Chollet

Pascal

et al. 2020

BMJ

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ObjectiveTo determine the effect of introducing prospective monitoring of outcomes using control charts and regular feedback on indicators to surgical teams on major adverse events in patients.DesignNational, parallel, cluster randomised trial embedding a difference-in-differences analysis.Setting40 surgical departments of hospitals across France.Participants155 362 adults who underwent digestive tract surgery. 20 of the surgical departments were randomised to prospective monitoring of outcomes using control charts with regular feedback on indicators (intervention group) and 20 to usual care only (control group).InterventionsProspective monitoring of outcomes using control charts, provided in sets quarterly, with regular feedback on indicators (intervention hospitals). To facilitate implementation of the programme, study champion partnerships were established at each site, comprising a surgeon and another member of the surgical team (surgeon, anaesthetist, or nurse), and were trained to conduct team meetings, display posters in operating rooms, maintain a logbook, and devise an improvement plan.Main outcome measuresThe primary outcome was a composite of major adverse events (inpatient death, intensive care stay, reoperation, and severe complications) within 30 days after surgery. Changes in surgical outcomes were compared before and after implementation of the programme between intervention and control hospitals, with adjustment for patient mix and clustering.Results75 047 patients were analysed in the intervention hospitals (37 579 before and 37 468 after programme implementation) versus 80 315 in the control hospitals (41 548 and 38 767). After introduction of the control chart, the absolute risk of a major adverse event was reduced by 0.9% (95% confidence interval 0.4% to 1.4%) in intervention compared with control hospitals, corresponding to 114 patients (70 to 280) who needed to receive the intervention to prevent one major adverse event. A significant decrease in major adverse events (adjusted ratio of odds ratios 0.89, 95% confidence interval 0.83 to 0.96), patient death (0.84, 0.71 to 0.99), and intensive care stay (0.85, 0.76 to 0.94) was found in intervention compared with control hospitals. The same trend was observed for reoperation (0.91, 0.82 to 1.00), whereas severe complications remained unchanged (0.96, 0.87 to 1.07). Among the intervention hospitals, the effect size was proportional to the degree of control chart implementation witnessed. Highly compliant hospitals experienced a more important reduction in major adverse events (0.84, 0.77 to 0.92), patient death (0.78, 0.63 to 0.97), intensive care stay (0.76, 0.67 to 0.87), and reoperation (0.84, 0.74 to 0.96).ConclusionsThe implementation of control charts with feedback on indicators to surgical teams was associated with concomitant reductions in major adverse events in patients. Understanding variations in surgical outcomes and how to provide safe surgery is imperative for improvements.Trial registrationClinicalTrials.gov NCT02569450.

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Evaluating the impact of healthcare interventions using routine data

Cited by 80 publications

References 39 publications

One Plus One Equals Two—will that do? A trial protocol for a Swedish multicentre randomised controlled trial to evaluate a clinical practice to reduce severe perineal trauma

One Plus One Equals Two—will that do? A trial protocol for a Swedish multicentre randomised controlled trial to evaluate a clinical practice to reduce severe perineal trauma

Regular performance feedback may be key to maintain good quality DKA management: results from a five-year study

Effect of monitoring surgical outcomes using control charts to reduce major adverse events in patients: cluster randomised trial

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