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"Unnecessary Procedures - statistics "
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Simplified diagnostic management of suspected pulmonary embolism (the YEARS study): a prospective, multicentre, cohort study
by
Hofstee, Herman
,
Brekelmans, Marjolein P
,
del Sol, Antonio Iglesias
in
Aged
,
Algorithms
,
Angiography
2017
Validated diagnostic algorithms in patients with suspected pulmonary embolism are often not used correctly or only benefit subgroups of patients, leading to overuse of computed tomography pulmonary angiography (CTPA). The YEARS clinical decision rule that incorporates differential D-dimer cutoff values at presentation, has been developed to be fast, to be compatible with clinical practice, and to reduce the number of CTPA investigations in all age groups. We aimed to prospectively evaluate this novel and simplified diagnostic algorithm for suspected acute pulmonary embolism.
We did a prospective, multicentre, cohort study in 12 hospitals in the Netherlands, including consecutive patients with suspected pulmonary embolism between Oct 5, 2013, to July 9, 2015. Patients were managed by simultaneous assessment of the YEARS clinical decision rule, consisting of three items (clinical signs of deep vein thrombosis, haemoptysis, and whether pulmonary embolism is the most likely diagnosis), and D-dimer concentrations. In patients without YEARS items and D-dimer less than 1000 ng/mL, or in patients with one or more YEARS items and D-dimer less than 500 ng/mL, pulmonary embolism was considered excluded. All other patients had CTPA. The primary outcome was the number of independently adjudicated events of venous thromboembolism during 3 months of follow-up after pulmonary embolism was excluded, and the secondary outcome was the number of required CTPA compared with the Wells' diagnostic algorithm. For the primary outcome regarding the safety of the diagnostic strategy, we used a per-protocol approach. For the secondary outcome regarding the efficiency of the diagnostic strategy, we used an intention-to-diagnose approach. This trial is registered with the Netherlands Trial Registry, number NTR4193.
3616 consecutive patients with clinically suspected pulmonary embolism were screened, of whom 151 (4%) were excluded. The remaining 3465 patients were assessed of whom 456 (13%) were diagnosed with pulmonary embolism at baseline. Of the 2946 patients (85%) in whom pulmonary embolism was ruled out at baseline and remained untreated, 18 patients were diagnosed with symptomatic venous thromboembolism during 3-month follow-up (0·61%, 95% CI 0·36–0·96) of whom six had fatal pulmonary embolism (0·20%, 0·07–0·44). CTPA was not indicated in 1651 (48%) patients with the YEARS algorithm compared with 1174 (34%) patients, if Wells' rule and fixed D-dimer threshold of less than 500 ng/mL would have been applied, a difference of 14% (95% CI 12–16).
In our study pulmonary embolism was safely excluded by the YEARS diagnostic algorithm in patients with suspected pulmonary embolism. The main advantage of the YEARS algorithm in our patients is the absolute 14% decrease of CTPA examinations in all ages and across several relevant subgroups.
This study was supported by unrestricted grants from the participating hospitals.
Journal Article
The impact of training informal health care providers in India: A randomized controlled trial
by
Chowdhury, Abhijit
,
Banerjee, Abhijit V.
,
Das, Jishnu
in
Anti-Bacterial Agents
,
Antibiotics
,
Assessments
2016
Many families in developing countries do not have access to medical doctors and instead receive health care from informal providers. Das et al. used “mystery” patients (trained actors) to test whether a 9-month training program improved the quality of care delivered by informal providers in West Bengal (see the Perspective by Powell-Jackson). The patients did not identify themselves to the providers and were not told which providers had participated in the training program. The results of this blinded assessment showed that medical doctors delivered better care than informal providers but that the training program closed much of the gap. Science , this issue p. 80 ; see also p. 34 Training helped informal providers deliver better care for angina, diarrhea, and asthma. [Also see Perspective by Powell-Jackson ] Health care providers without formal medical qualifications provide more than 70% of all primary care in rural India. Training these informal providers may be one way to improve the quality of care where few alternatives exist. We report on a randomized controlled trial assessing a program that provided 72 sessions of training over 9 months to 152 informal providers (out of 304). Using standardized patients (“mystery clients”), we assessed clinical practice for three different conditions to which both providers and trainers were blinded during the intervention, representative of the range of conditions that these providers normally diagnose and treat. Training increased correct case management by 7.9 percentage points (14.2%) but did not affect the use of unnecessary medicines and antibiotics. At a program cost of $175 per trainee, our results suggest that multitopic medical training offers an effective short-run strategy to improve health care.
Journal Article
Caesarean deliveries in China
2017
Background
The caesarean section rate has risen rapidly in China. The purpose of this retrospective study was to estimate caesarean section rates and indications by hospital facility level in Mainland China to investigate reasons contributing to the high rate.
Methods
This cross-sectional hospital-based study collected data from 39 hospitals in three geographical regions in China, covering 14 different provinces, municipalities, and autonomous regions, including 20 tertiary health hospitals and 19 secondary hospitals. Data from all women who gave birth at these hospitals during 2011 were included.
Results
A total of 112,138 women who gave birth after 24 weeks of gestation were surveyed. Of these pregnancies, 54.5% (61,084 cases) resulted in caesarean section, non-indicated caesarean section accounted for 38.4% of caesarean sections. Overall caesarean section rates were higher at the tertiary level hospitals (55.9%) compared to the secondary level hospitals (50.9%). The secondary level hospitals had higher rates of non-indicated caesarean section (48.9% of caesarean sections) compared to tertiary level hospitals (34.5% of caesarean sections). The rate of caesarean section on maternal request was higher in the secondary hospitals (16.6%) than in the tertiary hospitals (10%) (
P
< 0.001), as well as the caesarean section rate for CPD prior to labour. Operative vaginal deliveries were overall rare (1.2%) with 90.9% (1200/1320 cases) performed in the tertiary hospitals.
Conclusions
Caesarean section on maternal request accounts for a large portion of China’s high caesarean section rate, especially in the secondary hospitals. The first step to reduced caesarean section rates is to decrease the number of non-indicated caesarean sections.
Journal Article
A Randomized Trial of Displaying Paid Price Information on Imaging Study and Procedure Ordering Rates
by
Lisa Soleymani Lehmann
,
Koplan, Kate E
,
Sequist, Thomas D
in
Accountable care organizations
,
Colon
,
Electronic medical records
2017
BackgroundPrior studies have demonstrated how price transparency lowers the test-ordering rates of trainees in hospitals, and physician-targeted price transparency efforts have been viewed as a promising cost-controlling strategy.ObjectiveTo examine the effect of displaying paid-price information on test-ordering rates for common imaging studies and procedures within an accountable care organization (ACO).DesignBlock randomized controlled trial for 1 year.SubjectsA total of 1205 fully licensed clinicians (728 primary care, 477 specialists).InterventionStarting January 2014, clinicians in the Control arm received no price display; those in the intervention arms received Single or Paired Internal/External Median Prices in the test-ordering screen of their electronic health record. Internal prices were the amounts paid by insurers for the ACO’s services; external paid prices were the amounts paid by insurers for the same services when delivered by unaffiliated providers.Main MeasuresOrdering rates (orders per 100 face-to-face encounters with adult patients): overall, designated to be completed internally within the ACO, considered “inappropriate” (e.g., MRI for simple headache), and thought to be “appropriate” (e.g., screening colonoscopy).Key ResultsWe found no significant difference in overall ordering rates across the Control, Single Median Price, or Paired Internal/External Median Prices study arms. For every 100 encounters, clinicians in the Control arm ordered 15.0 (SD 31.1) tests, those in the Single Median Price arm ordered 15.0 (SD 16.2) tests, and those in the Paired Prices arms ordered 15.7 (SD 20.5) tests (one-way ANOVA p-value 0.88). There was no difference in ordering rates for tests designated to be completed internally or considered to be inappropriate or appropriate.ConclusionsDisplaying paid-price information did not alter how frequently primary care and specialist clinicians ordered imaging studies and procedures within an ACO. Those with a particular interest in removing waste from the health care system may want to consider a variety of contextual factors that can affect physician-targeted price transparency.
Journal Article
The Rates and Medical Necessity of Cesarean Delivery in the Era of the Two-Child Policy in Hubei and Gansu Provinces, China
2019
Objectives. To describe the cesarean rates in different child policy periods and assess the medical necessity of cesareans during the 2-child policy period. Methods. We collected hospital-level aggregate data on 93 745 deliveries and individual-level data on 27 977 deliveries from 6 hospitals in the Hubei and Gansu provinces of China from 2013 to 2016. Experts in gynecology and obstetrics assessed the medical necessity of 1024 randomly selected cesareans in 2016. Results. The overall cesarean rate decreased significantly from 45.1% in the 1-child policy period (January 2013–September 2014) to 40.4% in the selective 2-child policy period (October 2014–July 2016) and further to 38.9% in the universal 2-child policy period (August 2016–December 2016). The rate of cesarean delivery on maternal request decreased by 46.3%, whereas the rate of cesarean delivery indicated by a previous cesarean delivery increased by 118.8% (P < .001). The experts assessed 222 (21.6%) cesareans as lacking medical necessity. Conclusions. The overall cesarean rate in Hubei and Gansu provinces decreased after the implementation of the 2-child policy, and one fifth of cesareans might be nonessential.
Journal Article
Comparison of routine and on-demand prescription of chest radiographs in mechanically ventilated adults: a multicentre, cluster-randomised, two-period crossover study
by
Ioos, Vincent
,
Simon, Tabassome
,
Salomon, Laurence
in
Adults
,
Biological and medical sciences
,
Clinical medicine
2009
Present guidelines recommend routine daily chest radiographs for mechanically ventilated patients in intensive care units. However, some units use an on-demand strategy, in which chest radiographs are done only if warranted by the patient's clinical status. By comparison between routine and on-demand strategies, we aimed to establish which strategy was more efficient and effective for optimum patient care.
In a cluster-randomised, open-label crossover study, we randomly assigned 21 intensive care units at 18 hospitals in France to use a routine or an on-demand strategy for prescription of chest radiographs during the first of two treatment periods. Units used the alternative strategy in the second period. Each treatment period lasted for the time taken for enrolment and study of 20 consecutive patients per intensive care unit; patients were monitored until discharge from the unit or for up to 30 days' mechanical ventilation, whichever was first. Units enrolled 967 patients, but 118 were excluded because they had been receiving mechanical ventilation for less than 2 days. The primary outcome measure was the mean number of chest radiographs per patient-day of mechanical ventilation. Analysis was by intention to treat. This study is registered with
ClinicalTrials.gov, number
NCT00893672.
11 intensive care units were randomly allocated to use a routine strategy to order chest radiographs in the first treatment period, and 10 units to use an on-demand strategy. Overall, 424 patients had 4607 routine chest radiographs (mean per patient-day of mechanical ventilation 1·09, 95% CI 1·05–1·14), and 425 had 3148 on-demand chest radiographs (mean 0·75, 0·67–0·83), which corresponded to a reduction of 32% (95% CI 25–38) with the on-demand strategy (p<0·0001).
Our results strongly support adoption of an on-demand strategy in preference to a routine strategy to decrease use of chest radiographs in mechanically ventilated patients without a reduction in patients' quality of care or safety.
Assistance Publique-Hôpitaux de Paris (Direction Régionale de la Recherche Clinique Ile de France).
Journal Article
Re-Purposing the Ordering of Routine Laboratory Tests in Hospitalized Medical Patients (RePORT): protocol for a multicenter stepped-wedge cluster randomised trial to evaluate the impact of a multicomponent intervention bundle to reduce laboratory test over-utilization
2024
Background
Laboratory test overuse in hospitals is a form of healthcare waste that also harms patients. Developing and evaluating interventions to reduce this form of healthcare waste is critical. We detail the protocol for our study which aims to implement and evaluate the impact of an evidence-based, multicomponent intervention bundle on repetitive use of routine laboratory testing in hospitalized medical patients across adult hospitals in the province of British Columbia, Canada.
Methods
We have designed a stepped-wedge cluster randomized trial to assess the impact of a multicomponent intervention bundle across 16 hospitals in the province of British Columbia in Canada. We will use the Knowledge to Action cycle to guide implementation and the RE-AIM framework to guide evaluation of the intervention bundle. The primary outcome will be the number of routine laboratory tests ordered per patient-day in the intervention versus control periods. Secondary outcome measures will assess implementation fidelity, number of all common laboratory tests used, impact on healthcare costs, and safety outcomes. The study will include patients admitted to adult medical wards (internal medicine or family medicine) and healthcare providers working in these wards within the participating hospitals. After a baseline period of 24 weeks, we will conduct a 16-week pilot at one hospital site. A new cluster (containing approximately 2–3 hospitals) will receive the intervention every 12 weeks. We will evaluate the sustainability of implementation at 24 weeks post implementation of the final cluster. Using intention to treat, we will use generalized linear mixed models for analysis to evaluate the impact of the intervention on outcomes.
Discussion
The study builds upon a multicomponent intervention bundle that has previously demonstrated effectiveness. The elements of the intervention bundle are easily adaptable to other settings, facilitating future adoption in wider contexts. The study outputs are expected to have a positive impact as they will reduce usage of repetitive laboratory tests and provide empirically supported measures and tools for accomplishing this work.
Trial Registration
This study was prospectively registered on April 8, 2024, via ClinicalTrials.gov Protocols Registration and Results System (NCT06359587).
https://classic.clinicaltrials.gov/ct2/show/NCT06359587?term=NCT06359587&recrs=ab&draw=2&rank=1
Journal Article
Appropriate use of blood cultures in the emergency department through machine learning (ABC): study protocol for a randomised controlled non-inferiority trial
by
Schade, Rogier
,
Ridderikhof, Milan L
,
Wiersinga, Joost
in
accident & emergency medicine
,
Anti-Bacterial Agents - therapeutic use
,
Antibiotics
2024
IntroductionThe liberal use of blood cultures in emergency departments (EDs) leads to low yields and high numbers of false-positive results. False-positive, contaminated cultures are associated with prolonged hospital stays, increased antibiotic usage and even higher hospital mortality rates. This trial aims to investigate whether a recently developed and validated machine learning model for predicting blood culture outcomes can safely and effectively guide clinicians in withholding unnecessary blood culture analysis.Methods and analysisA randomised controlled, non-inferiority trial comparing current practice with a machine learning-guided approach. The primary objective is to determine whether the machine learning based approach is non-inferior to standard practice based on 30-day mortality. Secondary outcomes include hospital length-of stay and hospital admission rates. Other outcomes include model performance and antibiotic usage. Participants will be recruited in the EDs of multiple hospitals in the Netherlands. A total of 7584 participants will be included.Ethics and disseminationPossible participants will receive verbal information and a paper information brochure regarding the trial. They will be given at least 1 hour consideration time before providing informed consent. Research results will be published in peer-reviewed journals. This study has been approved by the Amsterdam University Medical Centers’ local medical ethics review committee (No 22.0567). The study will be conducted in concordance with the principles of the Declaration of Helsinki and in accordance with the Medical Research Involving Human Subjects Act, General Data Privacy Regulation and Medical Device Regulation.Trial registration number NCT06163781.
Journal Article
Effect of Release of the First Pediatric Appropriate Use Criteria on Transthoracic Echocardiogram Ordering Practice
by
Welch, Elizabeth
,
Sachdeva, Ritu
,
Benavidez, Oscar J.
in
Adolescent
,
Cardiology
,
Cardiovascular
2016
Pediatric appropriate use criteria (AUC) were recently published for initial outpatient transthoracic echocardiography (TTE). The purpose of this study was to determine the effect of AUC publication on TTE ordering patterns of pediatric cardiologists. Data were prospectively collected on patients who had initial outpatient TTE ordered before (phase I, April to September 2014) and 3 months after (phase II, January to April 2015) AUC document publication at 6 centers. Site investigators assessed each study's indication and assigned AUC appropriateness as “appropriate” (A), “may be appropriate” (M), “rarely appropriate” (R), or “unclassifiable.” One hundred three physicians ordered 4,562 TTEs (2,655 phase I and 1,907 phase II). Overall, there was no statistically significant change in the proportion of A, M, or unclassifiable, but R decreased (12.0% to 9.6%, p = 0.01). There was significant variability among the centers in the percentage of studies for indications rated R (4.9% to 34.8%). There was no significant change in any of the appropriateness ratings at 4 centers, a decrease in R and an increase in A at 1 and a decrease in R and increase in unclassifiable at another. The first pediatric AUC document had only a small impact on physician ordering behavior for initial TTEs, including a small decrease in R. There was a significant variability in appropriateness of studies among centers. These data suggest that active educational interventions are required to substantially improve the appropriate use of pediatric TTE in the outpatient setting.
Journal Article
Effectiveness of WHO-recommended antenatal care visits, ultrasonography, and health education in reducing unnecessary caesarean sections among pregnant women in Bangladesh: a hospital-based randomised controlled trial
by
Dewan, Farhana
,
Masud, Sumaya Binte
,
Misty, Kamrunnahar
in
Adult
,
Bangladesh
,
Cesarean section
2025
The rate of caesarean sections (C-sections) is increasing globally, with many procedures being performed without clinical indication. We aimed to explore whether implementing the eight antenatal care visits that include health education and four ultrasonographic examinations (intervention group (IG)) recommended by the World Health Organization (WHO) would reduce unnecessary C-sections among Bangladeshi pregnant women in comparison to the usual four antenatal care and two ultrasonogram exams (comparison group (CG)) currently in use within the country's healthcare system.
We designed a randomised controlled trial that included two tertiary and two non-tertiary hospitals in Bangladesh. The randomisation was done at the hospital level, whereby we randomly allocated the hospitals to the IG or CG, with one tertiary and one non-tertiary hospital in each arm. We conducted this trial between November 2021 and December 2022. Pregnant women of all ages without any complications requiring C-sections were enrolled in the allocated IG and CG hospitals. The primary outcome was the reduction in the number of unnecessary C-sections. We considered unnecessary C-sections when there was no proper indication for caesarean delivery. Alongside descriptive analysis, we used adjusted log-linear regression models to investigate the relationship between unnecessary C-sections and various contributing factors.
We enrolled 288 pregnant women from two intervention and two comparison hospitals, with 144 assigned to the IG and 144 to the CG (72 from each hospital). There were 183 complete, successful deliveries in total (50.27% in IG vs. 49.73% in CG; P = 0.903). Of these, 106 resulted in C-sections (39.62% in IG and 60.38% in CG; P = 0.001), with 70 assessed as being necessary (47.14% in IG and 52.86% in CG; P = 0.027) and 36 as being unnecessary (25% in IG and 75% in CG). There were significantly fewer unnecessary C-sections among the women in the IG (P = 0.027), who also had a significantly lower risk ratio of 0.64 (95% confidence interval = 0.54-0.77, P < 0.001) compared to the CG.
Our findings indicate that the WHO-recommended antenatal visits and their interventions were effective in reducing unnecessary C-sections by 50%.
Clinicaltrials.gov: NCT05135026.
Journal Article