Randomized trial vs. observational study of acupuncture for migraine found that patient characteristics differed but outcomes were similar

2007 ◽  
Vol 60 (3) ◽  
pp. 280-287 ◽  
Author(s):  
Klaus Linde ◽  
Andrea Streng ◽  
Andrea Hoppe ◽  
Wolfgang Weidenhammer ◽  
Stefan Wagenpfeil ◽  
...  
Keyword(s):  
Observational Study ◽  
Randomized Trial ◽  
Patient Characteristics

A controlled randomized trial of atypical depression: Study design and patient characteristics

1994 ◽  
Vol 35 (9) ◽  
pp. 617
Author(s):  
R.B. Jarrett ◽  
M.H. Schaffer ◽  
M.M. Down ◽  
Q.C. Cheng ◽  
C. Judd ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Study Design ◽  
Patient Characteristics ◽  
Atypical Depression

scholarly journals LIBERTI: A SMART study in plastic surgery

2018 ◽  
Vol 15 (3) ◽  
pp. 286-293
Author(s):  
Jonathan C Hibbard ◽  
Jonathan S Friedstat ◽  
Sonia M Thomas ◽  
Renee E Edkins ◽  
C Scott Hultman ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Precision Medicine ◽  
Laser Treatment ◽  
Population Level ◽  
Patient Characteristics ◽  
Patient Response ◽  
Multiple Assignment ◽  
Laser Treatments ◽  
Treatment Plans ◽  
Treatment Rules

Background/aims: Laser treatment of burns scars is considered by some providers to be standard of care. However, there is little evidence-based research as to the true benefit. A number of factors hinder evaluation of the benefit of laser treatment. These include significant heterogeneity in patient response and possible delayed effects from the laser treatment. Moreover, laser treatments are often provided sequentially using different types of equipment and settings, so there are effectively a large number of overall treatment options that need to be compared. We propose a trial capable of coping with these issues and that also attempts to take advantage of the heterogeneous response in order to estimate optimal treatment plans personalized to each individual patient. It will be the first large-scale randomized trial to compare the effectiveness of laser treatments for burns scars and, to our knowledge, the very first example of the utility of a Sequential Multiple Assignment Randomized Trial in plastic surgery. Methods: We propose using a Sequential Multiple Assignment Randomized Trial design to investigate the effect of various permutations of laser treatment on hypertrophic burn scars. We will compare and test hypotheses regarding laser treatment effects at a general population level. Simultaneously, we hope to use the data generated to discover possible beneficial personalized treatment plans, tailored to individual patient characteristics. Results: We show that the proposed trial has good power to detect laser treatment effect at the overall population level, despite comparing a large number of treatment combinations. The trial will simultaneously provide high-quality data appropriate for estimating precision-medicine treatment rules. We detail population-level comparisons of interest and corresponding sample size calculations. We provide simulations to suggest the power of the trial to detect laser effect and also the possible benefits of personalization of laser treatment to individual characteristics. Conclusion: We propose, to our knowledge, the first use of a Sequential Multiple Assignment Randomized Trial in surgery. The trial is rigorously designed so that it is reasonably straightforward to implement and powered to answer general overall questions of interest. The trial is also designed to provide data that are suitable for the estimation of beneficial precision-medicine treatment rules that depend both on individual patient characteristics and on-going real-time patient response to treatment.

scholarly journals Depletion-of-susceptibles bias in influenza vaccine waning studies: how to ensure robust results

2019 ◽  
Author(s):  
M. Lipsitch ◽  
E. Goldstein ◽  
G.T. Ray ◽  
B. Fireman
Keyword(s):  
Observational Study ◽  
Influenza Vaccine ◽  
Randomized Trial ◽  
Study Design ◽  
Null Hypothesis ◽  
Influenza Season ◽  
Calendar Time ◽  
Future Studies ◽  
Biased Estimates ◽  
Induced Immunity

SUMMARYVaccine effectiveness (VE) studies are subject to biases due to depletion of at-risk persons or of highly susceptible persons at different rates from different groups (depletion-of-susceptibles bias), a problem that can also lead to biased estimates of waning effectiveness, including spurious inference of waning when none exists. An alternative study design to identify waning is to study only vaccinated persons, and compare for each day the incidence in persons with earlier or later dates of vaccination. Prior studies suggested under what conditions this alternative would yield correct estimates of waning. Here we define the depletion-of-susceptibles process formally and show mathematically that for influenza vaccine waning studies, a randomized trial or corresponding observational study that compares incidence at a specific calendar time among individuals vaccinated at different times before the influenza season begins will not be vulnerable depletion-of-susceptibles bias in its inference of waning under the null hypothesis that none exists, and will – if waning does actually occur – underestimate the extent of waning. Such a design is thus robust in the sense that a finding of waning in that inference framework reflects actual waning of vaccine-induced immunity. We recommend such a design for future studies of waning, whether observational or randomized.

scholarly journals Are trends in billing for high-intensity emergency care explained by changes in services provided in the emergency department? An observational study among US Medicare beneficiaries

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019357 ◽  
Author(s):  
Laura G Burke ◽  
Robert C Wild ◽  
E John Orav ◽  
Renee Y Hsia
Keyword(s):  
Emergency Department ◽  
Observational Study ◽  
Emergency Care ◽  
High Intensity ◽  
Patient Characteristics ◽  
Medicare Beneficiaries ◽  
Absolute Increase ◽  
Hospital Admission Rate ◽  
Outpatient Visits ◽  
Change In Mean

ObjectiveThere has been concern that an increase in billing for high-intensity emergency care is due to changes in coding practices facilitated by electronic health records. We sought to characterise the trends in billing for high-intensity emergency care among Medicare beneficiaries and to examine the degree to which trends in high-intensity billing are explained by changes in patient characteristics and services provided in the emergency department (ED).Design, setting and participantsObservational study using traditional Medicare claims to identify ED visits at non-federal acute care hospitals for elderly beneficiaries in 2006, 2009 and 2012.Outcomes measuresBilling intensity was defined by emergency physician evaluation and management (E&M) codes. We tested for overall trends in high-intensity billing (E&M codes 99285, 99291 and 99292) and in services provided over time using linear regression models, adjusting for patient characteristics. Additionally, we tested for time trends in rates of admission to the hospital and to the intensive care unit (ICU). Next, we classified outpatient visits into 39 diagnosis categories and analysed the change in proportion of high-intensity visits versus the change in number of services. Finally, we quantified the extent to which trends in high-intensity billing are explained by changes in patient demographics and services provided in the ED using multivariable modelling.ResultsHigh-intensity visits grew from 45.8% of 671 103 visits in 2006 to 57.8% of 629 010 visits in 2012 (2.0% absolute increase per year; 95% CI 1.97% to 2.03%) as did the mean number of services provided for admitted (1.28 to 1.41; +0.02 increase in procedures per year; 95% CI 0.018 to 0.021) and discharged ED patients (7.1 to 8.6; +0.25 increase in services per year; 95% CI 0.245 to 0.255). There was a reduction in hospital admission rate from 40.1% to 35.9% (−0.68% per year; 95% CI −0.71% to −0.65%; P<0.001), while the ICU rate of admission rose from 11.7% to 12.3% (+0.11% per year; 95% CI 0.09% to 0.12%; P<0.001). When we stratified by diagnosis category, there was a moderate correlation between change in visits billed as high intensity and the change in mean number of services provided per visit (r=0.38; 95% CI 0.07 to 0.63). Trends in patient characteristics and services provided accounted moderately for the trend in practice intensity for outpatient visits (pseudo R2of 0.47) but very little for inpatient visits (0.051) and visits overall (0.148).ConclusionsIncreases in services provided in the ED moderately account for the trends in billing for high-intensity emergency care for outpatient visits.

scholarly journals Patient mortality after surgery on the surgeon’s birthday: observational study

BMJ ◽  
2020 ◽  
pp. m4381
Author(s):  
Hirotaka Kato ◽  
Anupam B Jena ◽  
Yusuke Tsugawa
Keyword(s):  
Mortality Rate ◽  
Observational Study ◽  
Life Events ◽  
Fixed Effects ◽  
Severity Of Illness ◽  
Patient Characteristics ◽  
Critical Access Hospitals ◽  
Fee For Service ◽  
Medicare Beneficiaries ◽  
Study Analysis

Abstract Objective To determine whether patient mortality after surgery differs between surgeries performed on surgeons’ birthdays compared with other days of the year. Design Retrospective observational study. Setting US acute care and critical access hospitals. Participants 100% fee-for-service Medicare beneficiaries aged 65 to 99 years who underwent one of 17 common emergency surgical procedures in 2011-14. Main outcome measures Patient postoperative 30 day mortality, defined as death within 30 days after surgery, with adjustment for patient characteristics and surgeon fixed effects. Results 980 876 procedures performed by 47 489 surgeons were analyzed. 2064 (0.2%) of the procedures were performed on surgeons’ birthdays. Patient characteristics, including severity of illness, were similar between patients who underwent surgery on a surgeon’s birthday and those who underwent surgery on other days. The overall unadjusted 30 day mortality on the operating surgeon’s birthday was 7.0% (145/2064) and that on other days was 5.6% (54 824/978 812). After adjusting for patient characteristics and surgeon fixed effects (effectively comparing outcomes of patients treated by the same surgeon on different days), patients who underwent surgery on a surgeon’s birthday exhibited higher mortality compared with patients who underwent surgery on other days (adjusted mortality rate, 6.9% v 5.6%; adjusted difference 1.3%, 95% confidence interval 0.1% to 2.5%; P=0.03). Event study analysis of patient mortality by day of surgery relative to a surgeon’s birthday found similar results. Conclusions Among Medicare beneficiaries who underwent common emergency surgeries, those who received surgery on the surgeon’s birthday experienced higher mortality compared with patients who underwent surgery on other days. These findings suggest that surgeons might be distracted by life events that are not directly related to work.

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