Causal inference in continuous time: an example on prostate cancer therapy.

In marginal structural models (MSMs), time is traditionally treated as a discrete parameter. In survival analysis on the other hand, we study processes that develop in continuous time. Therefore, Røysland (2011. A martingale approach to continuous-time marginal structural models. Bernoulli 17, 895-915) developed the continuous-time MSMs, along with continuous-time weights. The continuous-time weights are conceptually similar to the inverse probability weights that are used in discrete time MSMs. Here, we demonstrate that continuous-time MSMs may be used in practice. First, we briefly describe the causal model assumptions using counting process notation, and we suggest how causal effect estimates can be derived by calculating continuous-time weights. Then, we describe how additive hazard models can be used to find such effect estimates. Finally, we apply this strategy to compare medium to long-term differences between the two prostate cancer treatments radical prostatectomy and radiation therapy, using data from the Norwegian Cancer Registry. In contrast to the results of a naive analysis, we find that the marginal cumulative incidence of treatment failure is similar between the strategies, accounting for the competing risk of other death.

Non-parametric recurrent events analysis with BART and an application to the hospital admissions of patients with diabetes.

Much of survival analysis is concerned with absorbing events, i.e., subjects can only experience a single event such as mortality. This article is focused on non-absorbing or recurrent events, i.e., subjects are capable of experiencing multiple events. Recurrent events have been studied by many; however, most rely on the restrictive assumptions of linearity and proportionality. We propose a new method for analyzing recurrent events with Bayesian Additive Regression Trees (BART) avoiding such restrictive assumptions. We explore this new method via a motivating example of hospital admissions for diabetes patients and simulated data sets.

Towards a Core Outcome Set for Abdominal Aortic Aneurysm: Systematic Review of Outcomes Reported Following Intact and Ruptured Abdominal Aortic Aneurysm Repair.

OBJECTIVE: To encompass the needs of all stakeholders and allow effective data synthesis from trials, registries, and other studies; a core outcome set for infrarenal abdominal aortic aneurysm (AAA) repair is needed. In this first stage, the aim was to report the range, frequency, and time of pre-specified outcomes reported following AAA repair. DATA SOURCES: Medline, Embase, and CENTRAL databases 2010 - 2019 were searched using ProQuest Dialog™. REVIEW METHODS: The systematic review was reported to Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines (PRISMA), PROSPERO registration CRD42019130119. Outcomes were coded using Core Outcome Measures in Effectiveness Trials (COMET) taxonomy and presented separately for intact and rupture repairs, endovascular aneurysm repair (EVAR) and open repair, and time from repair (acute < 90 days vs. ≥ 1 year) (COMET Initiative 1582). RESULTS: For intact AAA and rupture repair, a total of 231 and 70 reports with 589 255 and 177 465 patients respectively were included: only 98 and 19 respectively provided ≥ 1 year outcomes. Most studies were retrospective, with 13 randomised trials of intact AAA repair and five randomised trials of ruptured AAA repair. For intact AAA, the most common pre-specified COMET taxonomy outcomes were mortality (181), vascular complications (137), and re-intervention (52). EVAR studies dominated the vascular outcomes in acute and later time periods: excluding 47 reports from device registries, reduced vascular outcomes to 83. For ruptured AAA, the three most common outcomes were mortality (64), vascular (11), and hospital stay (10). The range of outcomes reported was wide with functioning outcomes reported from most randomised trials but few retrospective studies. CONCLUSION: This review identifies the paucity of long term data and the disproportionate attention paid to vascular complications vs. patient functioning outcomes, this skew being accentuated by reporting from EVAR device registries. These data will inform focus groups, prior to a pan-European Delphi consensus, involving clinicians, patients, carers and providers, for developing core outcomes for repair of intact and ruptured AAA.

Effectiveness of Menghini-Type Needles for Endoscopic Ultrasound-Guided Fine-Needle Aspiration of Pancreatic Masses.

BACKGROUND: Cutting needles are thought to be effective as biopsy needles. A few types of cutting needles are available for endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), and the Menghini-type needle is an end-type cutting needle. AIMS: A prospective randomized controlled trial was conducted to compare the results of EUS-FNA using a Menghini-type needle (needle M) versus a conventional needle (needle S). METHODS: The main eligibility criteria were as follows: patients with a pancreatic mass referred for EUS-FNA, ≥ 20 years old, and a performance status < 4. The primary outcome was the sample quality. The secondary outcomes were factors associated with the sample quality, diagnostic accuracy, and adverse events. RESULTS: A total of 97 patients were enrolled in this study. The sample quality for total puncture with needle M (92.8%) was significantly higher than that with needle S (81.4%) (p = 0.0305). The tumor size (p = 0.033) and type of needle (p = 0.031) were significant factors associated with adequate tissue collection in univariate and multivariate analyses (odds ratio [OR] 2.71; 95% confidence interval [CI] 1.12-6.54; p = 0.027 for tumor size, and OR 2.93; 95% CI 1.23-8.21; p = 0.0153 for type of needle). The diagnostic accuracy of each needle was 88.7% (86/97) with needle M and 73.2% (71/97) with needle S. Adverse events occurred in 2 of the 97 patients (0.02%). CONCLUSION: A Menghini-type needle was able to obtain core tissue for histology more effectively than a conventional aspiration needle. TRIAL REGISTRATION NUMBERS: UMIN registration number of 000020668.

Use of the Donabedian Model as a Framework for COVID-19 Response at a Hospital in Suburban Westchester County, New York: A Facility-Level Case Report.

The purpose of this facility-level case report was to describe our facility's leadership process of applying the Donabedian model to structure an early response to the coronavirus disease pandemic relative to emergency care. Using the Donabedian model as a guide, both structure and process changes were implemented to maintain high-quality clinical outcomes as well as ED staff safety and engagement. Rapid changes to the model of care, both architecturally and through the expansion of universal precautions through personal protective equipment, created the foundation for what was to follow. Clinical, service quality, and staff safety outcomes were evaluated to demonstrate that the collaborative changes that follow a known process improvement model can be used to address the coronavirus disease pandemic. Further study is needed to compare the outcomes of this facility-level case study with those of others to evaluate the success of the measures outlined.

Benchmark performance of laparoscopic left lateral sectionectomy and right hepatectomy in expert centers.

BACKGROUND & AIMS: Herein, we aimed to establish benchmark values - based on a composite indicator of healthcare quality - for the performance of laparoscopic left lateral sectionectomy (LLLS) and laparoscopic right hepatectomy (LRH) using data from expert centers. METHODS: Data from a nationwide multicenter survey including all patients undergoing LLLS and LRH between 2000 and 2017 were analyzed. Textbook outcome (TO) completion was considered in patients fulfilling all 6 of the following characteristics: negative margins, no transfusion, no complication, no prolonged hospital stay, no readmission and no mortality. For each procedure, a cut-off laparoscopic liver resection (LLR) volume by center was associated with TO on multivariable analysis. These cut-offs defined the expert centers. The benchmark values were set at the 75th percentile of median outcomes among these expert centers. RESULTS: Among 4,400 LLRs performed in 29 centers, 855 patients who underwent LLLS and 488 who underwent LRH were identified. The overall incidences of TO after LLLS and LRH were 43.7% and 23.8%, respectively. LLR volume cut-offs of 25 LLR/year (odds ratio [OR] 2.45; bootstrap 95% CI 1.65-3.69; p = 0.001) and 35 LLR/year (OR 2.55; bootstrap 95% CI 1.34-5.63; p = 0.003) were independently associated with completion of TO after LLLS and LRH, respectively. Eight centers for LLLS and 6 centers for LRH, including 516 and 346 patients undergoing LLLS/LRH respectively, reached these cut-offs and were identified as expert centers. After LLLS, benchmark values of severe complication, mortality and TO completion were defined as ≤5.3%, ≤1.2% and ≥46.6%, respectively. After LRH, benchmark values of severe complication, mortality and TO completion were ≤20.4%, ≤2.8% and ≥24.2%, respectively. CONCLUSIONS: This study provides an up-to-date reference on the benchmark performance of LLLS and LRH in expert centers. LAY SUMMARY: In a nationwide French survey of laparoscopic liver resection, expert centers were defined according to the completion of a textbook outcome, which is a composite indicator of healthcare quality. Benchmark values regarding intra-operative details and outcomes were established using data from 516 patients with laparoscopic left lateral sectionectiomy and 346 patients with laparoscopic right hepatectomy from expert centers. These values should be used as a reference point to improve the quality of laparoscopic resections.

Annual Research Review: Universal and targeted strategies for assigning interventions to achieve population impact.

This article proposes that universal and targeted preventive interventions should be compared and evaluated in terms of their benefit-cost ratio in achieving population-wide impact on mental disorders and related outcomes. Universal approaches attempt to affect every individual in a population, whereas targeted approaches select candidates for intervention based on screening of demographic or behavioral characteristics. Unique assets and challenges of each approach in achieving population impact in a cost-efficient way are discussed, along with spillover effects, sensitivity and specificity, developmental processes, timing of intervention, and the relation between severity of risk and plasticity. A general targeted-efficiency framework is proposed as a heuristic to evaluate the collective merits of universal and targeted approaches in specific cases. A tiered approach that combines universal and targeted identification strategies is proposed, and examples are described. Issues for high-priority research are identified.

Recovery and Recovering in Older Adults with Schizophrenia: A 5-Tier Model.

RATIONALE: There are little recent data on clinical recovery in older adults with schizophrenia. This exploratory study uses an empirically measurable construct to address this issue. METHODS: From an original sample of 248 community-dwelling persons aged 55 and over with early-onset schizophrenia spectrum disorder, a subsample of 102 persons was reassessed at a mean of 52 months. Clinical recovery required meeting criteria for its two components: clinical remission and community integration. RESULTS: Prospective analysis generated a 5-tier taxonomy of recovery in which 12% remained persistently in clinical recovery at both baseline and follow-up (Tier 1) and 18% never met criteria of clinical recovery (Tier 5). The remaining 70% exhibited a variety of components of clinical recovery at baseline and follow-up (Tiers 2, 3, and 4). CONCLUSION: The findings generated a dynamic picture of recovery, with most persons being in varying states of "recovering." The 5-tier taxonomy of recovery adumbrated potential treatment strategies for each tier.

Artificial Intelligence and Behavioral Science Through the Looking Glass: Challenges for Real-World Application.

BACKGROUND: Artificial Intelligence (AI) is transforming the process of scientific research. AI, coupled with availability of large datasets and increasing computational power, is accelerating progress in areas such as genetics, climate change and astronomy [NeurIPS 2019 Workshop Tackling Climate Change with Machine Learning, Vancouver, Canada; Hausen R, Robertson BE. Morpheus: A deep learning framework for the pixel-level analysis of astronomical image data. Astrophys J Suppl Ser. 2020;248:20; Dias R, Torkamani A. AI in clinical and genomic diagnostics. Genome Med. 2019;11:70.]. The application of AI in behavioral science is still in its infancy and realizing the promise of AI requires adapting current practices. PURPOSES: By using AI to synthesize and interpret behavior change intervention evaluation report findings at a scale beyond human capability, the HBCP seeks to improve the efficiency and effectiveness of research activities. We explore challenges facing AI adoption in behavioral science through the lens of lessons learned during the Human Behaviour-Change Project (HBCP). METHODS: The project used an iterative cycle of development and testing of AI algorithms. Using a corpus of published research reports of randomized controlled trials of behavioral interventions, behavioral science experts annotated occurrences of interventions and outcomes. AI algorithms were trained to recognize natural language patterns associated with interventions and outcomes from the expert human annotations. Once trained, the AI algorithms were used to predict outcomes for interventions that were checked by behavioral scientists. RESULTS: Intervention reports contain many items of information needing to be extracted and these are expressed in hugely variable and idiosyncratic language used in research reports to convey information makes developing algorithms to extract all the information with near perfect accuracy impractical. However, statistical matching algorithms combined with advanced machine learning approaches created reasonably accurate outcome predictions from incomplete data. CONCLUSIONS: AI holds promise for achieving the goal of predicting outcomes of behavior change interventions, based on information that is automatically extracted from intervention evaluation reports. This information can be used to train knowledge systems using machine learning and reasoning algorithms.

Team Assessment and Decision Making Is Associated With Outcomes: A Trauma Video Review Analysis.

BACKGROUND: Teamwork is a critical element of trauma resuscitation. Assessment tools such as T-NOTECHS (Trauma NOn-TECHnical Skills) exist, but correlation with patient outcomes is unclear. Using emergency department thoracotomy (EDT), we sought to describe T-NOTECHS scores during resuscitations. We hypothesized that patients undergoing EDT whose resuscitations had better scores would be more likely to have return of spontaneous circulation (ROSC). METHODS: Continuously recording video was used to review all captured EDTs over a 24-mo period. We used a modification of the validated T-NOTECHS instrument to measure five domains on a 3-point scale (1 = best, 2 = average, 3 = worst). A total T-NOTECHS score was calculated by one of three reviewers. The primary outcome was ROSC. ROSC was defined as an organized rhythm no longer requiring internal cardiac compressions. Associations between variables and ROSC were examined using univariate regression. RESULTS: Sixty-one EDTs were captured. Nineteen patients had ROSC (31%) and 42 (69%) did not. The median T-NOTECHS score for all resuscitations was 8 [IQR 6-10]. As demographic and injury data (age, gender, mechanism, signs of life) were not associated with ROSC in univariate analysis, they were not considered for inclusion in a multivariable regression model. The association between overall T-NOTECHS score and ROSC did not reach statistical significance, but examination of the individual components of the T-NOTECHS score demonstrated that, compared to resuscitations that had "average" (2) or "worst" (3) scores on "Assessment and Decision Making," resuscitations with a "best" score were 5 times more likely to lead to ROSC. CONCLUSIONS: Although the association between overall T-NOTECHS scores and ROSC did not reach statistical significance, better scores in the domain of assessment and decision making are associated with improved rates of ROSC in patients arriving in cardiac arrest who undergo EDT. LEVEL OF EVIDENCE: Level IV Therapeutic/Care Management.

Outcomes and care practices for preterm infants born at less than 33 weeks' gestation: a quality-improvement study.

BACKGROUND: Preterm birth is the leading cause of morbidity and mortality in children younger than 5 years. We report the changes in neonatal outcomes and care practices among very preterm infants in Canada over 14 years within a national, collaborative, continuous quality-improvement program. METHODS: We retrospectively studied infants born at 23-32 weeks' gestation who were admitted to tertiary neonatal intensive care units that participated in the Evidence-based Practice for Improving Quality program in the Canadian Neonatal Network from 2004 to 2017. The primary outcome was survival without major morbidity during the initial hospital admission. We quantified changes using process-control charts in 6-month intervals to identify special-cause variations, adjusted regression models for yearly changes, and interrupted time series analyses. RESULTS: The final study population included 50 831 infants. As a result of practice changes, survival without major morbidity increased significantly (56.6% [669/1183] to 70.9% [1424/2009]; adjusted odds ratio [OR] 1.08, 95% confidence interval [CI] 1.06-1.10, per year) across all gestational ages. Survival of infants born at 23-25 weeks' gestation increased (70.8% [97/137] to 74.5% [219/294]; adjusted OR 1.03, 95% CI 1.02-1.05, per year). Changes in care practices included increased use of antenatal steroids (83.6% [904/1081] to 88.1% [1747/1983]), increased rates of normothermia at admission (44.8% [520/1160] to 67.5% [1316/1951]) and reduced use of pulmonary surfactant (52.8% [625/1183] to 42.7% [857/2009]). INTERPRETATION: Network-wide quality-improvement activities that include better implementation of optimal care practices can yield sustained improvement in survival without morbidity in very preterm infants.

Development and validation of the Cambridge Multimorbidity Score.

BACKGROUND: Health services have failed to respond to the pressures of multimorbidity. Improved measures of multimorbidity are needed for conducting research, planning services and allocating resources. METHODS: We modelled the association between 37 morbidities and 3 key outcomes (primary care consultations, unplanned hospital admission, death) at 1 and 5 years. We extracted development (n = 300 000) and validation (n = 150 000) samples from the UK Clinical Practice Research Datalink. We constructed a general-outcome multimorbidity score by averaging the standardized weights of the separate outcome scores. We compared performance with the Charlson Comorbidity Index. RESULTS: Models that included all 37 conditions were acceptable predictors of general practitioner consultations (C-index 0.732, 95% confidence interval [CI] 0.731-0.734), unplanned hospital admission (C-index 0.742, 95% CI 0.737-0.747) and death at 1 year (C-index 0.912, 95% CI 0.905-0.918). Models reduced to the 20 conditions with the greatest combined prevalence/weight showed similar predictive ability (C-indices 0.727, 95% CI 0.725-0.728; 0.738, 95% CI 0.732-0.743; and 0.910, 95% CI 0.904-0.917, respectively). They also predicted 5-year outcomes similarly for consultations and death (C-indices 0.735, 95% CI 0.734-0.736, and 0.889, 95% CI 0.885-0.892, respectively) but performed less well for admissions (C-index 0.708, 95% CI 0.705-0.712). The performance of the general-outcome score was similar to that of the outcome-specific models. These models performed significantly better than those based on the Charlson Comorbidity Index for consultations (C-index 0.691, 95% CI 0.690-0.693) and admissions (C-index 0.703, 95% CI 0.697-0.709) and similarly for mortality (C-index 0.907, 95% CI 0.900-0.914). INTERPRETATION: The Cambridge Multimorbidity Score is robust and can be either tailored or not tailored to specific health outcomes. It will be valuable to those planning clinical services, policymakers allocating resources and researchers seeking to account for the effect of multimorbidity.

A systematic approach to evaluate practice-based process- and outcome data applied to the treatment of neovascular age-related macular degeneration.

BACKGROUND: Following the principles of value-based health care, outcomes and processes of daily-practice eye care need to be systematically evaluated. We illustrate an approach that can be used to support data-driven quality improvements. We used patient data regarding the treatment of neovascular age-related macular degeneration (nAMD). METHODS: In a cohort study, we reviewed medical records of patients with nAMD confirmed on fluorescein angiography (FA). Patients were treated with intravitreal injections with bevacizumab; ranibizumab; or photodynamic therapy (PDT). Visual acuity (VA), ophthalmic exam results and treatments were recorded. VA was compared between treatments by linear mixed model. Diagnosis was re-evaluated on the original FAs. Outcome analysis was performed by 1) selecting VA as the relevant outcome parameter; 2) Preventing selection by comparing treatments with historical untreated cohort and cohorts from the literature, 3) correcting for confounding due to lesion type, and 4) identifying relevant process variables that affect the outcome. These were severity of disease at presentation, and doctor- and patient dependent process variables. RESULTS: In total, 473 eyes were included. At 12 months, change in VA was 0.54, 0.48, 0.09, and 0.07 LogMAR in the no-treatment, photodynamic therapy (PDT), bevacizumab, and ranibizumab groups, respectively. Lesion type on FA differed between groups. Diagnosis of nAMD could not be confirmed in 104 patients. Patient delay, inaccurate diagnosis and treatment intervals may have impacted outcomes. CONCLUSIONS: The effect of PDT was small to absent. Anti-VEGFs were effective and appeared as effective as in RCTs. Correct selection of a comparator cohort and addressing confounding, including confounding by indication and effect modification, are needed to achieve valid results and interpretation. Patient delay, diagnosis accuracy, indication for and application of treatment can potentially be improved to improve treatment outcomes. In a value-based care perspective, systematic evaluation of diagnostic accuracy, treatment indication, protocols, and outcomes of new interventions is needed at an early stage to improve outcomes.

A five-year longitudinal study of the relation between end-stage kidney disease as the outcomes.

BACKGROUND: Patients with end-stage kidney disease (ESKD) are required to undergo consecutive time-based blood and biochemical tests to determine the progression of the disease according to changes in their blood and biochemical data. This study employed a random intercept model to investigate whether time-based blood and biochemical data present any notable clinical meaning that can be used to track disease progression. METHODS: This study conducted a retrospective analysis on the dialytic data of 148 patients with ESKD, who received hemodialysis between January 2005 and December 2015. The patients were all at least 20 years old, and the data used included patient demographic information and results for at least 60 blood and biochemical tests. A random intercept model was used to analyze the relationships among blood and biochemical test results, explanatory variables of patient comorbidities, and time. RESULTS: The age range of patients was between 33 and 98 years, with an average of 66.1 years and those over 65 years old comprising 51.3% (n = 76) of the total. Furthermore, hypertension was found to be the most common comorbidity among patients (87.2%, n = 129), followed by anemia (48.6%, n = 72), diabetes (47.3%, n = 70), dyslipidemia (19.6%, n = 29), and peptic ulcer (19.6%, n = 29). Coronary atherosclerotic heart disease is a comorbidity that can serve as a strong and independent marker for prognosis in patients with ESKD. Serum creatinine level can serve as an alternative indicator because patients with ESKD and comorbid diabetes may exhibit increased creatinine levels. CONCLUSIONS: The results of a parameter estimation for longitudinal data analysis suggested that comorbidity and time were critical variables influencing blood and biochemical test results. Furthermore, WBC and HBC, HCT, albumin, protein, and creatinine levels were recognized as variables of critical significance. The results obtained in this study indicate that multimorbidity increases the treatment burden on patients, leading to polypharmacy. For this reason, comprehensive care and treatment of ESKD cannot rely solely on data from one single time point; instead, longitudinal analysis and other data that can affect patient prognosis must also be considered.

Bending the quality curve.

With this paper, we initiate the Supplement on Deepening our Understanding of Quality in Australia (DUQuA). DUQuA is an at-scale, cross-sectional research programme examining the quality activities in 32 large hospitals across Australia. It is based on, with suitable modifications and extensions, the Deepening our Understanding of Quality improvement in Europe (DUQuE) research programme, also published as a Supplement in this Journal, in 2014. First, we briefly discuss key data about Australia, the health of its population and its health system. Then, to provide context for the work, we discuss previous activities on the quality of care and improvement leading up to the DUQuA studies. Next, we present a selection of key interventional studies and policy and institutional initiatives to date. Finally, we conclude by outlining, in brief, the aims and scope of the articles that follow in the Supplement. This first article acts as a framing vehicle for the DUQuA studies as a whole. Aggregated, the series of papers collectively attempts an answer to the questions: what is the relationship between quality strategies, both hospital-wide and at department level? and what are the relationships between the way care is organised, and the actual quality of care as delivered? Papers in the Supplement deal with a multiplicity of issues including: how the DUQuA investigators made progress over time, what the results mean in context, the scales designed or modified along the way for measuring the quality of care, methodological considerations and provision of lessons learnt for the benefit of future researchers.

Plantar Pressures Following Surgical Release in Children With Clubfoot: Comparison of Posterior Release, Posteromedial Release, and Nonoperative Correction.

BACKGROUND: Functional deficits observed at long-term follow-up in surgically released clubfeet have led to the adoption of a nonoperative approach. Gait results reported at age 5 years found ankle motion was limited in clubfeet treated by posteromedial release (PMR), compared with those that required posterior release (PR) or remained nonoperative. The purpose of this study was to assess plantar pressures in clubfeet that required surgical correction by 5 years of age. METHODS: Pedobarograph data were collected at age 5 years on patients with clubfeet that underwent surgical correction due to residual deformity or recurrence. Plantar pressures were assessed by subdividing the foot into the medial/lateral hindfoot, midfoot, and forefoot regions. Variables included maximum force, contact area%, contact time% (CT%), the hindfoot-forefoot angle, and displacement of the center of pressure line. Surgical feet were divided into those that underwent an isolated PR versus PMR. A group of 72 clubfeet that remained nonoperative were matched by initial severity and used for comparison. RESULTS: Pedobarograph data from 53 patients (72 clubfeet; 25 PR and 47 PMR) showed minimal differences between the PR and PMR feet. Compared with the nonoperative group, both surgical groups had increased CT% in the medial hindfoot and medial midfoot regions. An increase in lateral hindfoot CT% was observed in the PMR group. In addition, CT% in the first metatarsal region in the PMR group was reduced compared with the nonoperative group. Lateralization is present across both surgical groups in the center of pressure line and hindfoot-forefoot angle. CONCLUSION: While there were minimal differences between surgical groups, patients who underwent PR exhibited pressure variables that were more comparable to the nonoperative group while the PMR group had greater deviations. LEVEL OF EVIDENCE: Level II-therapeutic.

Innovations in Mixed Methods Evaluations.

Mixed methods research-i.e., research that draws on both qualitative and quantitative methods in varying configurations-is well suited to address the increasing complexity of public health problems and their solutions. This review focuses specifically on innovations in mixed methods evaluations of intervention, program or policy (i.e., practice) effectiveness, and implementation. The article begins with an overview of the structure, function, and process of different mixed methods designs and then provides illustrations of their use in effectiveness studies, implementation studies, and combined effectiveness-implementation hybrid studies. The article then examines four specific innovations: procedures for transforming (or "quantitizing") qualitative data, application of rapid assessment and analysis procedures in the context of mixed methods studies, development of measures to assess implementation outcomes, and strategies for conducting both random and purposive sampling, particularly in implementation-focused evaluation research. The article concludes with an assessment of challenges to integrating qualitative and quantitative data in evaluation research.

Tracking quality: can embryology key performance indicators be used to identify clinically relevant shifts in pregnancy rate?

STUDY QUESTION: Can embryology key performance indicators (KPIs) detect shifts in laboratory performance that precede changes in clinical outcomes? SUMMARY ANSWER: Day 5 usable blastocyst rate (D5BUR) is an important embryology KPI that complements total usable blastocyst rate (TBUR) in its ability to rapidly identify adverse embryology outcomes, prior to changes in clinical outcomes. WHAT IS KNOWN ALREADY: The hypothesis that monitoring performance of an IVF laboratory using statistical process controls (SPCs) can act as an early warning signal of shifts in laboratory conditions is a hypothesis that requires validation. The Vienna consensus report recently defined KPIs for monitoring fresh IVF and ICSI cycles, but the effectiveness of using these KPIs for detecting clinically relevant shifts following changes in laboratory processes is unknown. STUDY DESIGN, SIZE, DURATION: A retrospective, multicentre, analysis of KPIs for 1971 fresh IVF and ICSI cycles during three consecutive 5-month periods (P1, P2 and P3) during which the culture medium was changed in the middle period. PARTICIPANTS/MATERIALS, SETTING, METHODS: ICSI fertilisation rate, IVF fertilisation rate, D5BUR, TBUR and clinical pregnancy rate (CPR) were tracked monthly and analysed for SPC using Shewhart control charts. Out-of-control KPIs were identified by warning (2-sigma) and control (3-sigma) limits. The effect of the laboratory culture medium change on embryology KPIs and cumulative CPR was investigated using a one-way ANOVA or Pearson Chi-squared test and logistic regression. MAIN RESULTS AND THE ROLE OF CHANCE: D5BUR decreased from 32 to 25% after the culture medium was changed, and the decrease was detected within 1 week after the change (P < 0.0001). D5BUR subsequently increased after a change back to the original medium. A decrease in CPR (51-36%) after the medium change was also observed but was not detected until 3 months after the shift in D5BUR (P = 0.0005). Overall, the change in culture medium independently influenced D5BUR, CPR and cumulative CPR. Importantly, TBUR (41%) was not affected by the change in culture medium, remaining within control limits for all three culture periods, indicating that the overall blastocyst rate alone may not sufficiently monitor embryology laboratory performance. LIMITATIONS REASONS FOR CAUTION: The statistical KPI monitoring system demonstrated by the current study may be less effective at identifying KPI shifts in smaller clinics with lower cycle volumes. Live-birth rate per cycle started was not included as a clinical KPI. WIDER IMPLICATIONS OF THE FINDINGS: This study demonstrates that statistical KPI monitoring systems have the potential to provide systematic, early detection of adverse outcomes in ART laboratories after planned or unexpected shifts in conditions. STUDY FUNDING/COMPETING INTEREST(S): No external funds were used for the study. The authors have no conflicts of interest. TRIAL REGISTRATION NUMBER: Not applicable.

Acute Angiographic and Intermediate-Term Clinical Results of Patients with Non-Left Main Coronary Bifurcation Lesions Treated with BVS by Jailed Semi-Inflated Balloon Technique and Provisional Side-Branch Stenting Strategy.

BACKGROUND: To evaluate the acute angiographic and intermediate-term clinical results of patients with non-left main (LM) coronary artery bifurcation disease (CABD) treated with BVS, as compared with those treated with DES, using the jailed semi-inflated balloon technique (JSIBT) for side branch (SB) protection and provisional stenting. METHODS AND RESULTS: Sixty-eight patients with non-LM CABD who had undergone provisional one-stent implantation with SB protection by JSIBT between January 2015 and December 2017 were retrospectively enrolled. Among them, 20 patients received Absorb BVS implantation and 48 patients received DES implantation. Patients in the BVS group were younger and had higher BMI, total cholesterol, low-density lipoprotein cholesterol, and hemoglobin but had lower serum creatinine and lower prevalence of prior PCI and MI. No SB balloon rupture/entrapment occurred in either group. The incidence of SB dissection/occlusion and SB in need of rewiring or stenting was rare in both groups and showed no significant difference between them. Postinterventional TIMI flow significantly increased in both groups. The intermediate-term clinical outcomes were good in terms of incidence of target lesion failure, target lesion revascularization, target vessel revascularization, myocardial infarction, and all-cause death in both groups. CONCLUSION: The use of JSIBT for treating CABD with modern BVS can provide SB protection as similar as those with DES, even with higher incidence of acute SB dissection/occlusion. The immediate angiographic results and acute and intermediate-term clinical outcomes were also similar in both groups. Our study results demonstrate that JSIBT might be a safe and alternative SB protection tool for BVS in patients with complex CABD.

ACS NSQIP Surgical Risk Calculator: Pilot Analysis on Feasibility in an Academic Safety Net Hospital.

BACKGROUND: Hospitals are looking for effective methods to track outcomes that are risk-adjusted for patient population characteristics. This is especially relevant for safety net hospitals (SNHs) servicing high-risk populations and in an era of quality-based reimbursement incentives. One such program with these goals is the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP). This is an institution-based quality audit whereby we determined the presence and consistency of charted data required to compute perioperative risk in the ACS NSQIP risk calculator. MATERIALS AND METHODS: A retrospective chart review of 28 elective colorectal procedures was performed at an urban, academic SNH over a 1-y period. For each case, it was determined whether the required NSQIP variables were readily presented via preoperative documentation. Univariate and bivariate statistics were employed to compare data field completion rates. RESULTS: Of the 28 reviewed patient charts, none (n = 0) had all preoperative risk documentation required to complete an ACS NSQIP risk analysis. 89.3% of charts (n = 25) had ≤ 55% of required data to complete a risk assessment. However on bivariate analysis, demographic variables were more likely to have been recorded (P < 0.001) than other risk factors. CONCLUSIONS: Preoperative risk assessment and corresponding charting practices at the SNH reviewed was fragmented and incomplete. There was lack of definitive documentation of risk factors and preoperative interventions used to modulate risk. Under current reimbursement models such as the MACRA Quality Payment Program, these findings are crucial for like-institutions to consider to critically evaluate their own documentation practices.