Background: Given the sudden and unexpected nature of an emergency caesarean section (EmCS) coupl... more Background: Given the sudden and unexpected nature of an emergency caesarean section (EmCS) coupled with an increased risk of psychological distress, it is particularly important to understand the psychosocial outcomes for women. The aim of this systematic literature review was to identify, collate and examine the evidence surrounding women's psychosocial outcomes of EmCS worldwide. Methods: The electronic databases of EMBASE, PubMed, Scopus, and PsycINFO were searched between November 2017 and March 2018. To ensure articles were reflective of original and recently published research, the search criteria included peer-reviewed research articles published within the last 20 years (1998 to 2018). All study designs were included if they incorporated an examination of women's psychosocial outcomes after EmCS. Due to inherent heterogeneity of study data, extraction and synthesis of both qualitative and quantitative data pertaining to key psychosocial outcomes were organised into coherent themes and analysis was attempted. Results: In total 17,189 articles were identified. Of these, 208 full text articles were assessed for eligibility. One hundred forty-nine articles were further excluded, resulting in the inclusion of 66 articles in the current systematic literature review. While meta-analyses were not possible due to the nature of the heterogeneity, key psychosocial outcomes identified that were negatively impacted by EmCS included post-traumatic stress, health-related quality of life, experiences, infant-feeding, satisfaction, and self-esteem. Post-traumatic stress was one of the most commonly examined psychosocial outcomes, with a strong consensus that EmCS contributes to both symptoms and diagnosis. Conclusions: EmCS was found to negatively impact several psychosocial outcomes for women in particular post-traumatic stress. While investment in technologies and clinical practice to minimise the number of EmCSs is crucial, further investigations are needed to develop effective strategies to prepare and support women who experience this type of birth.
IntroductionCardiovascular diseases (CVDs) have been associated with an increased risk of dementi... more IntroductionCardiovascular diseases (CVDs) have been associated with an increased risk of dementia; yet the evidence is mixed. This review critically appraises and synthesises current evidence exploring associations between dementia risk and CVD and their risk factors, including coronary heart disease, heart failure, atrial fibrillation, hypertension, hyperlipidaemia, and arterial stiffness.MethodsMEDLINE, Embase, PsycINFO, and the Cochrane Database of Systematic Reviews were searched to identify systematic reviews with meta-analyses investigating the association between at least one of the CVDs of interest and dementia risk. The Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Systematic Reviews was used to assess methodological quality.ResultsTwenty-five meta-analyses published between 2007 and 2021 were included. Studies largely consisted of cohorts from North America and Europe. Findings were variable, with coronary heart disease, heart failure, and atrial fibrilla...
Multiple imputation (MI) is increasingly being used to handlemissing data in epidemiologic resear... more Multiple imputation (MI) is increasingly being used to handlemissing data in epidemiologic research.When data on both the exposure and the outcomearemissing, an alternative to standardMI is the “multiple imputation, then deletion” (MID) method, which involves deleting imputed outcomes prior to analysis. While MID has been shown to provide efficiency gains over standard MI when analysis and imputation models are the same, the performance of MID in the presence of auxiliary variables for the incomplete outcome is not well understood. Using simulated data, we eval-uated the performance of standard MI and MID in regression settings where data were missing on both the outcome and the exposure and where an auxiliary variable associated with the incomplete outcome was included in the impu-tation model. When the auxiliary variable was unrelated to missingness in the outcome, both standard MI and MID produced negligible bias when estimating regression parameters, with standard MI being more ...
Objectives: To systematically review the quality of reporting on the application of switching adj... more Objectives: To systematically review the quality of reporting on the application of switching adjustment approaches in published oncology trials and industry submissions to the National Institute for Health and Care Excellence Although methods such as the rank preserving structural failure time model (RPSFTM) and inverse probability of censoring weights (IPCW) have been developed to address treatment switching, the approaches are not widely accepted within health technology assessment. This limited acceptance may partly be a consequence of poor reporting on their application. Methods: Published trials and industry submissions were obtained from searches of PubMed and nice.org.uk, respectively. The quality of reporting in these studies was judged against a checklist of reporting recommendations, which was developed by the authors based on detailed considerations of the methods. Results: Thirteen published trials and 8 submissions to nice.org.uk satisfied inclusion criteria. The quality of reporting around the implementation of the RPSFTM and IPCW methods was generally poor. Few studies stated whether the adjustment approach was prespecified, more than a third failed to provide any justification for the chosen method, and nearly half neglected to perform sensitivity analyses. Further, it was often unclear how the RPSFTM and IPCW methods were implemented. Conclusions: Inadequate reporting on the application of switching adjustment methods increases uncertainty around results, which may contribute to the limited acceptance of these methods by decision makers. The proposed reporting recommendations aim to support the improved interpretation of analyses undertaken to adjust for treatment switching.
Multiple imputation (MI) is increasingly being used to handle missing data in epidemiologic resea... more Multiple imputation (MI) is increasingly being used to handle missing data in epidemiologic research. When data on both the exposure and the outcome are missing, an alternative to standard MI is the "multiple imputation, then deletion" (MID) method, which involves deleting imputed outcomes prior to analysis. While MID has been shown to provide efficiency gains over standard MI when analysis and imputation models are the same, the performance of MID in the presence of auxiliary variables for the incomplete outcome is not well understood. Using simulated data, we evaluated the performance of standard MI and MID in regression settings where data were missing on both the outcome and the exposure and where an auxiliary variable associated with the incomplete outcome was included in the imputation model. When the auxiliary variable was unrelated to missingness in the outcome, both standard MI and MID produced negligible bias when estimating regression parameters, with standard M...
ABSTRACTBackgroundRepeat Rapid Response Team (RRT) calls are associated with increased mortality ... more ABSTRACTBackgroundRepeat Rapid Response Team (RRT) calls are associated with increased mortality risk to patients and pose a resource burden to organisations. Use of Non-Technical Skills (NTS) at calls has the potential to reduce potentially preventable repeat calling. NTS are usually improved through training, however this consumes time and financial resources. Modifications to the Rapid Response System (RRS) that promote use of NTS are worth exploring as a cost-effective alternative.MethodsA pre-post observational study of a RRS re-design on proportion of admissions each month subject to repeat RRT calling and number of calls per admission, with univariate and multivariable interrupted time series analyses comparing outcomes between study phases.ResultsThe proportion of admissions with repeat calls each month increased across both phases of the study period, but the increase was lower in the post re-design phase (change in adjusted regression slope -0.12 (standard error 0.07) post...
Background Repeat Rapid Response Team (RRT) calls are associated with increased in-hospital morta... more Background Repeat Rapid Response Team (RRT) calls are associated with increased in-hospital mortality risk and pose an organisation-level resource burden. Use of Non-Technical Skills (NTS) at calls has the potential to reduce potentially preventable repeat calling. NTS are usually improved through training, although this consumes time and financial resources. Re-designing the Rapid Response System (RRS) to promote use of NTS may provide a feasible alternative. Methods A pre-post observational study was undertaken to assess the effect of an RRS re-design that aimed to promote use of NTS during RRT calls. The primary outcome was the proportion of admissions each month subject to repeat RRT calling, and the average number of repeat calls per admission each month was the secondary outcome of interest. Univariate and multivariable interrupted time series analyses compared outcomes between the two study phases. Results The proportion of admissions with repeat calls each month increased ac...
Supplemental material, sj-pdf-8-mdm-10.1177_0272989X20978958 for Extrapolation of Survival Curves... more Supplemental material, sj-pdf-8-mdm-10.1177_0272989X20978958 for Extrapolation of Survival Curves Using Standard Parametric Models and Flexible Parametric Spline Models: Comparisons in Large Registry Cohorts with Advanced Cancer by Jodi Gray, Thomas Sullivan, Nicholas R. Latimer, Amy Salter, Michael J. Sorich, Robyn L. Ward and Jonathan Karnon in Medical Decision Making
Supplemental material, sj-pdf-2-mdm-10.1177_0272989X20978958 for Extrapolation of Survival Curves... more Supplemental material, sj-pdf-2-mdm-10.1177_0272989X20978958 for Extrapolation of Survival Curves Using Standard Parametric Models and Flexible Parametric Spline Models: Comparisons in Large Registry Cohorts with Advanced Cancer by Jodi Gray, Thomas Sullivan, Nicholas R. Latimer, Amy Salter, Michael J. Sorich, Robyn L. Ward and Jonathan Karnon in Medical Decision Making
Supplemental material, sj-pdf-3-mdm-10.1177_0272989X20978958 for Extrapolation of Survival Curves... more Supplemental material, sj-pdf-3-mdm-10.1177_0272989X20978958 for Extrapolation of Survival Curves Using Standard Parametric Models and Flexible Parametric Spline Models: Comparisons in Large Registry Cohorts with Advanced Cancer by Jodi Gray, Thomas Sullivan, Nicholas R. Latimer, Amy Salter, Michael J. Sorich, Robyn L. Ward and Jonathan Karnon in Medical Decision Making
J. Med. 1987; 317: 141–5. 13. van der Graaf R, van Delden JJ. Equipoise should be amended, not ab... more J. Med. 1987; 317: 141–5. 13. van der Graaf R, van Delden JJ. Equipoise should be amended, not abandoned. Clin. Trials 2011; 8: 408–16. 14. Johnson N, Lilford RJ, Brazier W. At what level of collective equipoise does a clinical trial become ethical? J. Med. Ethics 1991; 17: 30–4. 15. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) – a metadata-driven methodology and workflow process for providing translational research informatics support. J. Biomed. Inform. 2009; 42: 377–81.
Background It is often important to extrapolate survival estimates beyond the limited follow-up t... more Background It is often important to extrapolate survival estimates beyond the limited follow-up times of clinical trials. Extrapolated survival estimates can be highly sensitive to model choice; thus, appropriate model selection is crucial. Flexible parametric spline models have been suggested as an alternative to standard parametric models; however, their ability to extrapolate is not well understood. Aim To determine how well standard parametric and flexible parametric spline models predict survival when fitted to registry cohorts with artificially right-censored follow-up times. Methods Adults with advanced breast, colorectal, small cell lung, non–small cell lung, or pancreatic cancer with a potential follow-up time of 10 y were selected from the SEER 1973–2015 registry data set. Patients were classified into 15 cohorts by cancer and age group at diagnosis (18–59, 60–69, 70+ y). Follow-up times for each cohort were right censored at 20%, 35%, and 50% survival. Standard parametric...
Background: Given the sudden and unexpected nature of an emergency caesarean section (EmCS) coupl... more Background: Given the sudden and unexpected nature of an emergency caesarean section (EmCS) coupled with an increased risk of psychological distress, it is particularly important to understand the psychosocial outcomes for women. The aim of this systematic literature review was to identify, collate and examine the evidence surrounding women's psychosocial outcomes of EmCS worldwide. Methods: The electronic databases of EMBASE, PubMed, Scopus, and PsycINFO were searched between November 2017 and March 2018. To ensure articles were reflective of original and recently published research, the search criteria included peer-reviewed research articles published within the last 20 years (1998 to 2018). All study designs were included if they incorporated an examination of women's psychosocial outcomes after EmCS. Due to inherent heterogeneity of study data, extraction and synthesis of both qualitative and quantitative data pertaining to key psychosocial outcomes were organised into coherent themes and analysis was attempted. Results: In total 17,189 articles were identified. Of these, 208 full text articles were assessed for eligibility. One hundred forty-nine articles were further excluded, resulting in the inclusion of 66 articles in the current systematic literature review. While meta-analyses were not possible due to the nature of the heterogeneity, key psychosocial outcomes identified that were negatively impacted by EmCS included post-traumatic stress, health-related quality of life, experiences, infant-feeding, satisfaction, and self-esteem. Post-traumatic stress was one of the most commonly examined psychosocial outcomes, with a strong consensus that EmCS contributes to both symptoms and diagnosis. Conclusions: EmCS was found to negatively impact several psychosocial outcomes for women in particular post-traumatic stress. While investment in technologies and clinical practice to minimise the number of EmCSs is crucial, further investigations are needed to develop effective strategies to prepare and support women who experience this type of birth.
IntroductionCardiovascular diseases (CVDs) have been associated with an increased risk of dementi... more IntroductionCardiovascular diseases (CVDs) have been associated with an increased risk of dementia; yet the evidence is mixed. This review critically appraises and synthesises current evidence exploring associations between dementia risk and CVD and their risk factors, including coronary heart disease, heart failure, atrial fibrillation, hypertension, hyperlipidaemia, and arterial stiffness.MethodsMEDLINE, Embase, PsycINFO, and the Cochrane Database of Systematic Reviews were searched to identify systematic reviews with meta-analyses investigating the association between at least one of the CVDs of interest and dementia risk. The Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Systematic Reviews was used to assess methodological quality.ResultsTwenty-five meta-analyses published between 2007 and 2021 were included. Studies largely consisted of cohorts from North America and Europe. Findings were variable, with coronary heart disease, heart failure, and atrial fibrilla...
Multiple imputation (MI) is increasingly being used to handlemissing data in epidemiologic resear... more Multiple imputation (MI) is increasingly being used to handlemissing data in epidemiologic research.When data on both the exposure and the outcomearemissing, an alternative to standardMI is the “multiple imputation, then deletion” (MID) method, which involves deleting imputed outcomes prior to analysis. While MID has been shown to provide efficiency gains over standard MI when analysis and imputation models are the same, the performance of MID in the presence of auxiliary variables for the incomplete outcome is not well understood. Using simulated data, we eval-uated the performance of standard MI and MID in regression settings where data were missing on both the outcome and the exposure and where an auxiliary variable associated with the incomplete outcome was included in the impu-tation model. When the auxiliary variable was unrelated to missingness in the outcome, both standard MI and MID produced negligible bias when estimating regression parameters, with standard MI being more ...
Objectives: To systematically review the quality of reporting on the application of switching adj... more Objectives: To systematically review the quality of reporting on the application of switching adjustment approaches in published oncology trials and industry submissions to the National Institute for Health and Care Excellence Although methods such as the rank preserving structural failure time model (RPSFTM) and inverse probability of censoring weights (IPCW) have been developed to address treatment switching, the approaches are not widely accepted within health technology assessment. This limited acceptance may partly be a consequence of poor reporting on their application. Methods: Published trials and industry submissions were obtained from searches of PubMed and nice.org.uk, respectively. The quality of reporting in these studies was judged against a checklist of reporting recommendations, which was developed by the authors based on detailed considerations of the methods. Results: Thirteen published trials and 8 submissions to nice.org.uk satisfied inclusion criteria. The quality of reporting around the implementation of the RPSFTM and IPCW methods was generally poor. Few studies stated whether the adjustment approach was prespecified, more than a third failed to provide any justification for the chosen method, and nearly half neglected to perform sensitivity analyses. Further, it was often unclear how the RPSFTM and IPCW methods were implemented. Conclusions: Inadequate reporting on the application of switching adjustment methods increases uncertainty around results, which may contribute to the limited acceptance of these methods by decision makers. The proposed reporting recommendations aim to support the improved interpretation of analyses undertaken to adjust for treatment switching.
Multiple imputation (MI) is increasingly being used to handle missing data in epidemiologic resea... more Multiple imputation (MI) is increasingly being used to handle missing data in epidemiologic research. When data on both the exposure and the outcome are missing, an alternative to standard MI is the "multiple imputation, then deletion" (MID) method, which involves deleting imputed outcomes prior to analysis. While MID has been shown to provide efficiency gains over standard MI when analysis and imputation models are the same, the performance of MID in the presence of auxiliary variables for the incomplete outcome is not well understood. Using simulated data, we evaluated the performance of standard MI and MID in regression settings where data were missing on both the outcome and the exposure and where an auxiliary variable associated with the incomplete outcome was included in the imputation model. When the auxiliary variable was unrelated to missingness in the outcome, both standard MI and MID produced negligible bias when estimating regression parameters, with standard M...
ABSTRACTBackgroundRepeat Rapid Response Team (RRT) calls are associated with increased mortality ... more ABSTRACTBackgroundRepeat Rapid Response Team (RRT) calls are associated with increased mortality risk to patients and pose a resource burden to organisations. Use of Non-Technical Skills (NTS) at calls has the potential to reduce potentially preventable repeat calling. NTS are usually improved through training, however this consumes time and financial resources. Modifications to the Rapid Response System (RRS) that promote use of NTS are worth exploring as a cost-effective alternative.MethodsA pre-post observational study of a RRS re-design on proportion of admissions each month subject to repeat RRT calling and number of calls per admission, with univariate and multivariable interrupted time series analyses comparing outcomes between study phases.ResultsThe proportion of admissions with repeat calls each month increased across both phases of the study period, but the increase was lower in the post re-design phase (change in adjusted regression slope -0.12 (standard error 0.07) post...
Background Repeat Rapid Response Team (RRT) calls are associated with increased in-hospital morta... more Background Repeat Rapid Response Team (RRT) calls are associated with increased in-hospital mortality risk and pose an organisation-level resource burden. Use of Non-Technical Skills (NTS) at calls has the potential to reduce potentially preventable repeat calling. NTS are usually improved through training, although this consumes time and financial resources. Re-designing the Rapid Response System (RRS) to promote use of NTS may provide a feasible alternative. Methods A pre-post observational study was undertaken to assess the effect of an RRS re-design that aimed to promote use of NTS during RRT calls. The primary outcome was the proportion of admissions each month subject to repeat RRT calling, and the average number of repeat calls per admission each month was the secondary outcome of interest. Univariate and multivariable interrupted time series analyses compared outcomes between the two study phases. Results The proportion of admissions with repeat calls each month increased ac...
Supplemental material, sj-pdf-8-mdm-10.1177_0272989X20978958 for Extrapolation of Survival Curves... more Supplemental material, sj-pdf-8-mdm-10.1177_0272989X20978958 for Extrapolation of Survival Curves Using Standard Parametric Models and Flexible Parametric Spline Models: Comparisons in Large Registry Cohorts with Advanced Cancer by Jodi Gray, Thomas Sullivan, Nicholas R. Latimer, Amy Salter, Michael J. Sorich, Robyn L. Ward and Jonathan Karnon in Medical Decision Making
Supplemental material, sj-pdf-2-mdm-10.1177_0272989X20978958 for Extrapolation of Survival Curves... more Supplemental material, sj-pdf-2-mdm-10.1177_0272989X20978958 for Extrapolation of Survival Curves Using Standard Parametric Models and Flexible Parametric Spline Models: Comparisons in Large Registry Cohorts with Advanced Cancer by Jodi Gray, Thomas Sullivan, Nicholas R. Latimer, Amy Salter, Michael J. Sorich, Robyn L. Ward and Jonathan Karnon in Medical Decision Making
Supplemental material, sj-pdf-3-mdm-10.1177_0272989X20978958 for Extrapolation of Survival Curves... more Supplemental material, sj-pdf-3-mdm-10.1177_0272989X20978958 for Extrapolation of Survival Curves Using Standard Parametric Models and Flexible Parametric Spline Models: Comparisons in Large Registry Cohorts with Advanced Cancer by Jodi Gray, Thomas Sullivan, Nicholas R. Latimer, Amy Salter, Michael J. Sorich, Robyn L. Ward and Jonathan Karnon in Medical Decision Making
J. Med. 1987; 317: 141–5. 13. van der Graaf R, van Delden JJ. Equipoise should be amended, not ab... more J. Med. 1987; 317: 141–5. 13. van der Graaf R, van Delden JJ. Equipoise should be amended, not abandoned. Clin. Trials 2011; 8: 408–16. 14. Johnson N, Lilford RJ, Brazier W. At what level of collective equipoise does a clinical trial become ethical? J. Med. Ethics 1991; 17: 30–4. 15. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) – a metadata-driven methodology and workflow process for providing translational research informatics support. J. Biomed. Inform. 2009; 42: 377–81.
Background It is often important to extrapolate survival estimates beyond the limited follow-up t... more Background It is often important to extrapolate survival estimates beyond the limited follow-up times of clinical trials. Extrapolated survival estimates can be highly sensitive to model choice; thus, appropriate model selection is crucial. Flexible parametric spline models have been suggested as an alternative to standard parametric models; however, their ability to extrapolate is not well understood. Aim To determine how well standard parametric and flexible parametric spline models predict survival when fitted to registry cohorts with artificially right-censored follow-up times. Methods Adults with advanced breast, colorectal, small cell lung, non–small cell lung, or pancreatic cancer with a potential follow-up time of 10 y were selected from the SEER 1973–2015 registry data set. Patients were classified into 15 cohorts by cancer and age group at diagnosis (18–59, 60–69, 70+ y). Follow-up times for each cohort were right censored at 20%, 35%, and 50% survival. Standard parametric...
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