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This systematic review and meta-analysis examines the impact of quality improvement interventions on central line–associated bloodstream infections in adult intensive care units. Studies were identified through Medline and manual searches (1995–June 2012). Random-effects meta-analysis obtained pooled odds ratios (ORs) and 95% confidence intervals (CIs). Meta-regression assessed the impact of bundle/checklist interventions and high baseline rates on intervention effect. Forty-one before–after studies identified an infection rate decrease (OR, 0.39 [95% CI, .33–.46]; P < .001). This effect was more pronounced for trials implementing a bundle or checklist approach (P = .03). Furthermore, meta-analysis of 6 interrupted time series studies revealed an infection rate reduction 3 months postintervention (OR, 0.30 [95% CI, .10–.88]; P = .03). There was no difference in infection rates between studies with low or high baseline rates (P = .18). These results suggest that quality improvement interventions contribute to the prevention of central line–associated bloodstream infections. Implementation of care bundles and checklists appears to yield stronger risk reductions.

Late-onset sepsis (LOS) is a life-threatening complication in preterm infants, with reported incidence rates of 1%-30% that vary by clinical and geographical factors. Quality improvement (QI) bundles integrating infection control, nutrition, and device management show promise in reducing LOS, but evidence remains fragmented due to heterogeneous definitions and mixed study populations. A systematic review and meta-analysis of QI studies was conducted across PubMed, Embase, Cochrane Library, and Web of Science (inception to March 19th, 2025). Studies were included if they reported pre-post QI outcomes for LOS in preterm infants (gestational age < 37 weeks), with effect sizes synthesized as odds ratios (ORs) and 95% confidence intervals (CIs). Heterogeneity was evaluated using , with random-effects models for ≥ 50%. Subgroup analyses explored LOS definition impacts (time windows: ≥48 h, ≥72 h, other) and meta-regression tested covariates (study year, sample size, quality). Of 9,705 identified studies, 29 (21 for meta-analysis,  = 29,120 infants) met criteria. QI bundles significantly reduced LOS in very low birth weight (VLBW) infants (pooled OR = 0.47, 95% CI [0.38-0.58], = 88.7%) and extremely low birth weight (ELBW) infants (OR = 0.49, 95% CI [0.29-0.83], = 80.6%). Core components included multidisciplinary teams (25/29), hand hygiene (21/29), and central line management (22/29). Subgroup analysis showed varying effects by LOS definition: OR = 0.35 (95% CI [0.19-0.64]) for ≥ 48 h, OR = 0.50 (95% CI [0.39-0.64]) for ≥ 72 h, and OR = 0.71 (95% CI [0.61-0.82]) for ill-defined thresholds. Meta-regression identified no significant modifiers (all > 0.0), but publication bias was detected in VLBW analyses (Egger's test,  < 0.0). QI bundles significantly reduce LOS in preterm infants, including VLBW and ELBW subgroups, through core components like multidisciplinary teams, hand hygiene, and central line management. Given outcome variations by diagnostic criteria, standardizing LOS definitions is crucial. These bundles should be integrated into routine care globally. Future efforts should prioritize standardized reporting, antibiotic stewardship, and equitable implementation, especially in low-resource settings, by building on existing evidence and broader healthcare principles.

Background Effective communication is an interaction between two or more people that produces a desired effect and is a key element of quality of care for patients with advanced and serious illness and their family members. Suboptimal provider-patient/family communication is common, with negative effects on patient/family-centered outcomes. Objectives To systematically review the evidence for effectiveness of communication-related quality improvement interventions for patients with advanced and serious illness and to explore the effectiveness of consultative and integrative interventions. Data Sources MEDLINE, CINAHL, PsycINFO, Cochrane, and DARE from 2000 through December 2011 and reference list of eligible articles and reviews. Study Eligibility Criteria, Participants And Interventions Prospective, controlled quality improvement studies in populations with life-limiting or severe life-threatening illness with a primary intervention focus of improving communication with patients and/or families. Study Appraisal and Synthesis Methods Two investigators independently screened and abstracted data on patient/family-centered outcomes. Results We included 20 studies; 13 (65 %) were in intensive care. We found four intervention types: (1) family meetings with the usual team (11 studies, 77 % found improvement in healthcare utilization), (2) palliative care teams (5 studies, 50 % found improvement in healthcare utilization), (3) ethics consultation (2 studies, 100 % found improvement in healthcare utilization), and (4) physician-patient communication (2 studies, no significant improvement in healthcare utilization). Among studies addressing the outcomes of patient/family satisfaction, 22 % found improvement; among studies addressing healthcare utilization (e.g., length of stay), 73 % found improvement. Results suggest that consultative interventions, as opposed to integrative ones, may be more effective, but more research is needed. Limitations Study heterogeneity did not allow quantitative synthesis. Conclusions and Implications of Key Findings Communication in the care of patients with advanced and serious illness can be improved using quality improvement interventions, particularly for healthcare utilization as an outcome. Interventions may be more effective using a consultative approach.

Background Each year, 2.2 million intrapartum-related deaths (intrapartum stillbirths and first day neonatal deaths) occur worldwide with 99% of them taking place in low- and middle-income countries. Despite the accelerated increase in the proportion of deliveries taking place in health facilities in these settings, the stillborn and neonatal mortality rates have not reduced proportionately. Poor quality of care in health facilities is attributed to two-thirds of these deaths. Improving quality of care during the intrapartum period needs investments in evidence-based interventions. We aim to evaluate the quality improvement package—Scaling Up Safer Bundle Through Quality Improvement in Nepal (SUSTAIN)—on intrapartum care and intrapartum-related mortality in public hospitals of Nepal. Methods We will conduct a stepped wedge cluster randomized controlled trial in eight public hospitals with each having least 3000 deliveries a year. Each hospital will represent a cluster with an intervention transition period of 2 months in each. With a level of significance of 95%, the statistical power of 90% and an intra-cluster correlation of 0.00015, a study period of 19 months should detect at least a 15% change in intrapartum-related mortality. Quality improvement training, mentoring, systematic feedback, and a continuous improvement cycle will be instituted based on bottleneck analyses in each hospital. All concerned health workers will be trained on standard basic neonatal resuscitation and essential newborn care. Portable fetal heart monitors (Moyo®) and neonatal heart rate monitors (Neobeat®) will be introduced in the hospitals to identify fetal distress during labor and to improve neonatal resuscitation. Independent research teams will collect data in each hospital on intervention inputs, processes, and outcomes by reviewing records and carrying out observations and interviews. The dose-response effect will be evaluated through process evaluations. Discussion With the global momentum to improve quality of intrapartum care, better understanding of QI package within a health facility context is important. The proposed package is based on experiences from a similar previous scale-up trial carried out in Nepal. The proposed evaluation will provide evidence on QI package and technology for implementation and scale up in similar settings. Trial registration number ISRCTN16741720 . Registered on 2 March 2019.

Background: Many patients with kidney failure will live longer and healthier lives if they receive a kidney transplant rather than dialysis. However, multiple barriers prevent patients from accessing this treatment option. Objective: To determine if a quality improvement intervention provided in chronic kidney disease (CKD) programs (vs. usual care) enables more patients with no recorded contraindications to kidney transplant to complete more steps toward receiving a kidney transplant. Design: This protocol describes a pragmatic 2-arm, parallel-group, open-label, registry-based, cluster-randomized clinical trial—the Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) trial. Setting: All 26 CKD programs in Ontario, Canada, with a trial start date of November 1, 2017. The original end date of March 31, 2021 (3.4 years) has been extended to December 31, 2021 (4.1 years) due to the COVID-19 pandemic. Participants: During the trial, the 26 CKD programs are expected to care for more than 10 000 adult patients with CKD (including patients approaching the need for dialysis and patients receiving dialysis) with no recorded contraindications to a kidney transplant. Intervention: Programs were randomly allocated to provide a quality improvement intervention or usual care. The intervention has 4 main components: (1) local quality improvement teams and administrative support; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders. Primary Outcome: The primary outcome is the number of key steps completed toward receiving a kidney transplant analyzed at the cluster level (CKD program). The following 4 unique steps per patient will be counted: (1) patient referred to a transplant center for evaluation, (2) at least one living kidney donor candidate contacts a transplant center for an intended recipient and completes a health history questionnaire to begin their evaluation, (3) patient added to the deceased donor transplant wait list, and (4) patient receives a kidney transplant from a living or deceased donor. Planned Primary Analysis: Study data will be obtained from Ontario’s linked administrative healthcare databases. An intent-to-treat analysis will be conducted comparing the primary outcome between randomized groups using a 2-stage approach. First stage: residuals are obtained from fitting a regression model to individual-level variables ignoring intervention and clustering effects. Second stage: residuals from the first stage are aggregated at the cluster level as the outcome. Limitations: It may not be possible to isolate independent effects of each intervention component, the usual care group could adopt intervention components leading to contamination bias, and the relatively small number of clusters could mean the 2 arms are not balanced on all baseline prognostic factors. Conclusions: The EnAKT LKD trial will provide high-quality evidence on whether a multi-component quality improvement intervention helps patients complete more steps toward receiving a kidney transplant. Trial registration: Clinicaltrials.gov; identifier: NCT03329521.

Background Stepped wedge designs have gained recognition as a method for rigorously assessing implementation of evidence-based quality improvement interventions (QIIs) across multiple healthcare sites. In theory, this design uses random assignment of sites to successive QII implementation start dates based on a timeline determined by evaluators. However, in practice, QII timing is often controlled more by site readiness. We propose an alternate version of the stepped wedge design that does not assume the randomized timing of implementation while retaining the method’s analytic advantages and applying to a broader set of evaluations. To test the feasibility of a nonrandomized stepped wedge design, we developed simulated data on patient care experiences and on QII implementation that had the structures and features of the expected data from a planned QII. We then applied the design in anticipation of performing an actual QII evaluation. Methods We used simulated data on 108,000 patients to model nonrandomized stepped wedge results from QII implementation across nine primary care sites over 12 quarters. The outcome we simulated was change in a single self-administered question on access to care used by Veterans Health Administration (VA), based in the United States, as part of its quarterly patient ratings of quality of care. Our main predictors were QII exposure and time. Based on study hypotheses, we assigned values of 4 to 11 % for improvement in access when sites were first exposed to implementation and 1 to 3 % improvement in each ensuing time period thereafter when sites continued with implementation. We included site-level (practice size) and respondent-level (gender, race/ethnicity) characteristics that might account for nonrandomized timing in site implementation of the QII. We analyzed the resulting data as a repeated cross-sectional model using HLM 7 with a three-level hierarchical data structure and an ordinal outcome. Levels in the data structure included patient ratings, timing of adoption of the QII, and primary care site. Results We were able to demonstrate a statistically significant improvement in adoption of the QII, as postulated in our simulation. The linear time trend while sites were in the control state was not significant, also as expected in the real life scenario of the example QII. Conclusions We concluded that the nonrandomized stepped wedge design was feasible within the parameters of our planned QII with its data structure and content. Our statistical approach may be applicable to similar evaluations.

Background: Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) is a quality improvement intervention designed to enhance access to kidney transplantation and living kidney donation. We conducted a cluster-randomized clinical trial to evaluate the effect of the intervention versus usual care on completing key steps toward receiving a kidney transplant. Objective: To prespecify the statistical analysis plan for the EnAKT LKD trial. Design: The EnAKT LKD trial is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized, superiority, clinical trial. Randomization was performed at the level of the chronic kidney disease (CKD) programs (the “clusters”). Setting: Twenty-six CKD programs in Ontario, Canada. Participants: More than 10 000 patients with advanced CKD (ie, patients approaching the need for dialysis or receiving maintenance dialysis) with no recorded contraindication to receiving a kidney transplant. Methods: The trial data (including patient characteristics and outcomes) will be obtained from linked administrative health care databases (the “registry”). Stratified covariate-constrained randomization was used to allocate the 26 CKD programs (1:1) to provide the intervention or usual care from November 1, 2017, to December 31, 2021 (4.17 years). CKD programs in the intervention arm received the following: (1) support for local quality improvement teams and administrative needs; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders. Outcomes: The primary outcome is completing key steps toward receiving a kidney transplant, where up to 4 unique steps per patient will be considered: (1) patient referred to a transplant center for evaluation, (2) a potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient, (3) patient added to the deceased donor transplant waitlist, and (4) patient receives a kidney transplant from a living or deceased donor. Analysis plan: Using an intent-to-treat approach, the primary outcome will be analyzed using a patient-level constrained multistate model adjusting for the clustering in CKD programs. Trial Status: The EnAKT LKD trial period is November 1, 2017, to December 31, 2021. We expect to analyze and report the results once the data for the trial period is available in linked administrative health care databases. Trial Registration: The EnAKT LKD trial is registered with the U.S. National Institute of Health at clincaltrials.gov (NCT03329521 available at https://clinicaltrials.gov/ct2/show/NCT03329521). Statistical Analytic Plan: Version 1.0 August 26, 2022.

Purpose The use of surgical antibiotic prophylaxis (SAP) in children is poorly characterized. Our aim was to evaluate the effectiveness of a quality improvement (QI) intervention targeting SAP in children, by means of a multicenter prospective intervention study, with a before and after design. Methods We prospectively investigated elective surgical procedures performed in children <18 years, prior to the QI intervention, after the intervention and at 9-month follow-up. The primary outcomes were adherence to SAP indications and SAP appropriateness, defined considering antibiotic choice, timing of first dose and duration of administration. We compared SAP adherence and appropriateness prior the QI intervention, to the post-intervention and the follow-up. We considered patient and procedure characteristics as covariates in two logistic regression models to assess the effect of the QI intervention on SAP adherence and appropriateness. Results We collected information on 2383 procedures (pre-intervention: 784; post-intervention: 790; follow-up: 809). The QI intervention had a significant impact on the adherence to SAP indications (86.6% in the post-intervention, compared to 82.0% prior to the intervention; p  < 0.05), and on its appropriateness (35.7% compared to 19.9%; p  < 0.01). The impact of the intervention on SAP appropriateness was maintained at follow-up (38.3%; p  < 0.01 compared to pre-intervention). All components of SAP appropriateness significantly improved after the intervention and at follow-up. The logistic regression analyses confirmed the effect of intervention in improving adherence to SAP indications and appropriateness. Conclusions Following the QI intervention, there was a significant improvement in quality of SAP in pediatric surgery, though more efforts are needed to increase SAP appropriateness.

Background To improve quality of care and patient outcomes, health system decision-makers need to identify and implement effective interventions. An increasing number of systematic reviews document the effects of quality improvement programs to assist decision-makers in developing new initiatives. However, limitations in the reporting of primary studies and current meta-analysis methods (including approaches for exploring heterogeneity) reduce the utility of existing syntheses for health system decision-makers. This study will explore the role of innovative meta-analysis approaches and the added value of enriched and updated data for increasing the utility of systematic reviews of complex interventions. Methods/Design We will use the dataset from our recent systematic review of 142 randomized trials of diabetes quality improvement programs to evaluate novel approaches for exploring heterogeneity. These will include exploratory methods, such as multivariate meta-regression analyses and all-subsets combinatorial meta-analysis. We will then update our systematic review to include new trials and enrich the dataset by surveying authors of all included trials. In doing so, we will explore the impact of variables not, reported in previous publications, such as details of study context, on the effectiveness of the intervention. We will use innovative analytical methods on the enriched and updated dataset to identify key success factors in the implementation of quality improvement interventions for diabetes. Decision-makers will be involved throughout to help identify and prioritize variables to be explored and to aid in the interpretation and dissemination of results. Discussion This study will inform future systematic reviews of complex interventions and describe the value of enriching and updating data for exploring heterogeneity in meta-analysis. It will also result in an updated comprehensive systematic review of diabetes quality improvement interventions that will be useful to health system decision-makers in developing interventions to improve outcomes for people with diabetes. Systematic review registration PROSPERO registration no. CRD42013005165

Background Cardiovascular diseases (CVD) are the largest cause of death and disability in Australia. Australian national guidelines for the primary prevention of CVD recommend that all adults without CVD and aged 45 years or more are screened for their absolute risk of CVD every 2 years. Despite the compelling evidence to address CVD risk, treatment gaps remain and evidence suggests that much of the shortcomings are attributed to the performance of primary care practices. To address this issue, a quality improvement initiative is being implemented in a large urban multidisciplinary primary care practice in the South West region of Victoria, Australia. The key outcome of this intervention will be to increase the use and acceptability of CVD risk assessment guidelines. To ensure the intervention is tracking toward its objectives, a robust monitoring and evaluation framework was established. Method/design A novel framework that assimilates key traditional and theory-driven evaluation practices was developed to assess the impact of the intervention. The framework approach is termed the integrated model of evaluation (IMoE). Researchers and stakeholders convened several times to discuss and develop the evaluation protocol and align it with the quality intervention. The main objective here is to explore the feasibility of an integrated approach to evaluating clinical quality improvement interventions. The sub-objectives are to test the alignment of the IMoE to clinical quality improvement projects and its ability to derive findings to the satisfaction of stakeholders. The design and establishment of the evaluation approach is discussed in further detail in this article. Discussion The novel feature of the IMoE is its emphasis on tracking ‘change’ in practices that lead to quality improvement. This emphasis suits the quality improvement theme of this initiative as identification of change elements and explanation behind change is necessary to sustain and promote quality improvement. The other principle behind development of this model, which emphasises practicality in implementation, is to ensure stakeholders gain greatest value from the commissioning of program evaluation. By incorporating practical components and leaving out esoteric concepts, this approach ensures evaluation can be undertaken in realistic timeframes. Ethics approval The quality improvement intervention and evaluation framework received approval from the Deakin University Human Research Ethics Committee (Approval Number: 2017-313).