| 1. |
- Aerts, Marc, et al.
(författare)
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Pooled individual patient data from five countries were used to derive a clinical prediction rule for coronary artery disease in primary care.
- 2017
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Ingår i: Journal of Clinical Epidemiology. - : Elsevier. - 0895-4356 .- 1878-5921. ; 81, s. 120-128
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To construct a clinical prediction rule for coronary artery disease (CAD) presenting with chest pain in primary care.STUDY DESIGN AND SETTING: Meta-Analysis using 3,099 patients from five studies. To identify candidate predictors, we used random forest trees, multiple imputation of missing values, and logistic regression within individual studies. To generate a prediction rule on the pooled data, we applied a regression model that took account of the differing standard data sets collected by the five studies.RESULTS: The most parsimonious rule included six equally weighted predictors: age ≥55 (males) or ≥65 (females) (+1); attending physician suspected a serious diagnosis (+1); history of CAD (+1); pain brought on by exertion (+1); pain feels like "pressure" (+1); pain reproducible by palpation (-1). CAD was considered absent if the prediction score is <2. The area under the ROC curve was 0.84. We applied this rule to a study setting with a CAD prevalence of 13.2% using a prediction score cutoff of <2 (i.e., -1, 0, or +1). When the score was <2, the probability of CAD was 2.1% (95% CI: 1.1-3.9%); when the score was ≥ 2, it was 43.0% (95% CI: 35.8-50.4%).CONCLUSIONS: Clinical prediction rules are a key strategy for individualizing care. Large data sets based on electronic health records from diverse sites create opportunities for improving their internal and external validity. Our patient-level meta-analysis from five primary care sites should improve external validity. Our strategy for addressing site-to-site systematic variation in missing data should improve internal validity. Using principles derived from decision theory, we also discuss the problem of setting the cutoff prediction score for taking action.
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| 2. |
- Anttila, Sten, et al.
(författare)
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Conclusiveness resolves the conflict between quality of evidence and imprecision in GRADE
- 2016
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Ingår i: Journal of Clinical Epidemiology. - : Elsevier BV. - 1878-5921 .- 0895-4356. ; 2016:75, s. 1-5
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Tidskriftsartikel (refereegranskat)abstract
- The objective of our article is to show how “quality of evidence” and “imprecision,” as they are defined in Grading of Recommendations Assessment, Development, and Evaluation (GRADE) articles, may lead to confusion. We focus only on the context of systematic reviews.
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| 3. |
- Bonander, Carl, et al.
(författare)
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Participation weighting based on sociodemographic register data improved external validity in a population-based cohort study
- 2019
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Ingår i: Journal of Clinical Epidemiology. - : Elsevier BV. - 0895-4356. ; 108, s. 54-63
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To investigate whether inverse probability of participation weighting (IPPW) using register data on sociodemographic and disease history variables can improve external validity in a cohort study with selective participation. Study Design and Setting: We fitted various IPPW models by logistic regression using register data for the participants (n = 1,111) and nonparticipants (n = 1,132) of a Swedish cohort study. For each of six diagnostic groups, we then estimated (1) weighted disease prevalence proportions and (2) weighted cross-sectional associations (odds ratios) between sociodemographic variables and disease prevalence. Using register data on the remaining individuals of the entire study population of men and women aged 50-64 years (n = 22,259), we addressed how the choice of variables used for IPPW influenced estimation errors. Results: Disease prevalence proportions were generally underestimated in the absence of IPPW but became markedly closer to population values after IPPW using sociodemographic variables. We found limited evidence of selective participation bias in association estimates, but IPPW improved external validity when bias was present. Conclusions: IPPW using sociodemographic register data can improve the external validity of disease prevalence estimates in cohort studies with selective participation. The performance of IPPW for association estimates merits further investigations in longitudinal settings and larger cohorts. © 2018 Elsevier Inc.
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| 4. |
- Burström, Lage, et al.
(författare)
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Daily text messages used as a method for assessing low back pain among workers
- 2016
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Ingår i: Journal of Clinical Epidemiology. - : Elsevier BV. - 0895-4356 .- 1878-5921. ; :70, s. 45-51
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: To evaluate a method for collecting data concerning low back pain (LBP) using daily text messages and to characterize the reported LBP in terms of intensity, variability, and episodes.STUDY DESIGN AND SETTING: We conducted a cohort study of LBP among workers used by a mining company. The participants were asked to answer the question "How much pain have you had in your lower back in the last 24 hours on a scale from 0 to 10, where 0 = no pain and 10 = the worst pain imaginable" once a day for 5 weeks, with this process being repeated 6 months later.RESULTS: A total of 121 workers participated in the first period of data collection, and 108 participated in the second period. The daily response rate was 93% for both periods, and cluster analysis was shown to be a feasible statistical method for clustering LBP into subgroups of low, medium, and high pain. The daily text messages method also worked well for assessing the episodic nature of LBP.CONCLUSION: We have demonstrated a method for repeatedly measuring of LBP using daily text messages. The data permitted clustering into subgroups and could be used to define episodes of LBP.
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| 5. |
- Campbell, William, et al.
(författare)
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Prediction impact curve is a new measure integrating intervention effects in the evaluation of risk models
- 2016
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Ingår i: Journal of Clinical Epidemiology. - : Elsevier BV. - 0895-4356 .- 1878-5921. ; 69, s. 89-95
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Tidskriftsartikel (refereegranskat)abstract
- Objective: We propose a new measure of assessing the performance of risk models, the area under the prediction impact curve (auPIC), which quantifies the performance of risk models in terms of their average health impact in the population. Study Design and Setting: Using simulated data, we explain how the prediction impact curve (PIC) estimates the percentage of events prevented when a risk model is used to assign high-risk individuals to an intervention. We apply the PIC to the Atherosclerosis Risk in Communities (ARIC) Study to illustrate its application toward prevention of coronary heart disease. Results: We estimated that if the ARIC cohort received statins at baseline, 5% of events would be prevented when the risk model was evaluated at a cutoff threshold of 20% predicted risk compared to 1% when individuals were assigned to the intervention without the use of a model. By calculating the auPIC, we estimated that an average of 15% of events would be prevented when considering performance across the entire interval. Conclusion: We conclude that the PIC is a clinically meaningful measure for quantifying the expected health impact of risk models that supplements existing measures of model performance.
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| 6. |
- Dal-Re, Rafael, et al.
(författare)
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A limited number of medicines pragmatic trials had potential for waived informed consent following the 2016 CIOMS ethical guidelines
- 2019
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Ingår i: Journal of Clinical Epidemiology. - : ELSEVIER SCIENCE INC. - 0895-4356 .- 1878-5921. ; 114, s. 60-71
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: European regulations do not allow modification or waiver of informed consent for medicines randomized controlled trials (RCTs) where the three 2016 Council for International Organizations of Medical Sciences (CIOMS) provisions are met (consent would be impractical or unfeasible, yet the trial would have high social value and pose no or minimal risk to participants). We aimed to identify whether any such trials of medicines were being conducted in Europe. Study Design and Setting: This is a survey of all phase 4 "ongoing" RCTs on the EU clinical trial register between July 1, 2016 and June 30, 2018, to identify those with potentially high levels of pragmatism. Trials that were excluded were as follows: those conducted on rare diseases; conducted on healthy volunteers (except those assessing vaccines); masked (single-, double-blind) trials; single-center trials; those where one could expect to lead patients to prefer one intervention over the other; and miscellaneous reasons. The degree of pragmatism of the RCTs was self-assessed by trials' investigators by means of the PRECIS-2 tool. Investigators of those trials considered to be highly pragmatic assessed the fulfillment of the three CIOMS provisions. Seven patients assessed the social value of the RCTs. Finally, 33 members of 11 research ethics committees (RECs) assessed the social value of the trials and whether they posed no more than minimal risk to participants. Investigators, patients, and REC members assessed the fulfillment of the CIOMS provisions as "yes," "not sure" or "no." Results: Of the 638 phase 4 trials, 420 were RCTs, and 21 of these (5%) were candidates to be pragmatic. Investigators of 15 of these 21 RCTs self-assessed their trial's degree of pragmatism: 14 were highly pragmatic. Of these 14, eight fulfilled the three CIOMS provisions. Assessments by patients and RECs were inconsistent for several trials. Conclusions: We found few low-risk participant-level pragmatic RCTs that could be suitable for modified or waived participants' informed consent. European regulators should consider amending the current regulation and encouraging the conduct of such trials. (C) 2019 Elsevier Inc. All rights reserved.
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| 7. |
- De Meyer, Dorien, et al.
(författare)
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Delphi Procedure In Core Outcome Set Development : Rating Scale And Consensus Criteria Determined Outcome Selection
- 2019
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Ingår i: Journal of Clinical Epidemiology. - : Elsevier. - 0895-4356 .- 1878-5921. ; 111, s. 23-31
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To compare two different rating scales within one Delphi study for defining consensus in core outcome set development and to explore the influence of consensus criteria on the outcome selection.STUDY DESIGN: Randomized controlled parallel group trial with 1:1 allocation within the first Delphi round of the Core Outcome Set in the Incontinence-Associated Dermatitis (CONSIDER) project. Outcomes were rated on a three-point or nine-point Likert scale. Decisions about which outcomes to retain were determined by commonly used consensus criteria (i.e., (combinations of) proportions with restricted ranges, central tendency within a specific range and decrease in variance).RESULTS: Fifty-seven participants (group 1=28, group 2=29) rated 58 outcomes. The use of the nine-point scale resulted in almost twice as many outcomes being rated as 'critical' compared to the three-point scale (24 versus 13). Stricter criteria and combining criteria led to less outcomes being identified as 'critical'.CONCLUSION: The format of rating scales in Delphi studies for core outcome set development and the definition of the consensus criteria influence outcome selection. The use of the nine-point scale might be recommended to inform the consensus process for a subsequent rating or face-to-face meeting. The three-point scale might be preferred when determining final consensus.
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| 8. |
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| 9. |
- Gagliardi, A. R., et al.
(författare)
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The Clinician Guideline Determinants Questionnaire was developed and validated to support tailored implementation planning
- 2019
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Ingår i: Journal of Clinical Epidemiology. - : Elsevier BV. - 0895-4356. ; 113, s. 129-136
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: The purpose of this research was to generate and validate a questionnaire that identifies determinants of guideline use from the clinician perspective. Study Design and Setting: From January 2017 to March 2018, a seven-member six-country multidisciplinary team used a five-step multimethod design to search for and compile determinant frameworks, map items to determinants (content validity), select the best items for each determinant (content validity), refine wording of determinants and items (face validity), merge or separate items (construct validity), and review the final questionnaire. Results: The Clinician Guideline Determinants Questionnaire includes four sections: clinician demographic information (including two determinants: attitudes about/experience with guidelines), 26 close-ended items reflecting clinician- and guideline-specific determinants, four open-ended items reflecting enablers and barriers perceived as most important, and three items on learning style (preferred sources of guideline information). Conclusion: The Clinician Guideline Determinants Questionnaire is a comprehensive, validated instrument that addresses multiple potential determinants specific to guideline use from a clinician perspective. The Questionnaire can be used at multiple time points in the guideline development cycle to assess determinants of the use of new, updated, or adapted guidelines and before and after interventions to assess their impact on the determinants of guideline use. In future research, we will establish psychometric properties of the new questionnaire. © 2019 The Authors
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| 10. |
- Gerdin, M., et al.
(författare)
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Traumatic transfers: calibration is adversely affected when prediction models are transferred between trauma care contexts in India and the United States
- 2016
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Ingår i: Journal of Clinical Epidemiology. - : Elsevier BV. - 0895-4356 .- 1878-5921. ; 74, s. 177-186
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Tidskriftsartikel (refereegranskat)abstract
- Objective: We evaluated the transferability of prediction models between trauma care contexts in India and the United States and explored updating methods to adjust such models for new contexts. Study Design and Settings: Using a combination of prospective cohort and registry data from 3,728 patients of Towards Improved Trauma Care Outcomes in India (TITCO) and from 18,756 patients of the US National Trauma Data Bank (NTDB), we derived models in one context and validated them in the other, assessing them for discrimination and calibration using systolic blood pressure, heart rate, and Glasgow coma scale as candidate predictors. Results: Early mortality was 8% in the TITCO and 1-2% in the NTDB samples. Both models discriminated well, but the TITCO model overestimated the risk of mortality in NTDB patients, and the NTDB model underestimated the risk in TITCO patients. Conclusion: Transferability was good in terms of discrimination but poor in terms of calibration. It was possible to improve this mis-calibration by updating the models' intercept. This updating method could be used in samples with as few as 25 events.
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