Publications by authors named "Mohammed T Ansari"

62 Publications

SAGES guidelines for the surgical treatment of gastroesophageal reflux (GERD).

Surg Endosc 2021 Sep 19;35(9):4903-4917. Epub 2021 Jul 19.

Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.

Background: Gastroesophageal Reflux Disease (GERD) is an extremely common condition with several medical and surgical treatment options. A multidisciplinary expert panel was convened to develop evidence-based recommendations to support clinicians, patients, and others in decisions regarding the treatment of GERD with an emphasis on evaluating different surgical techniques.

Methods: Literature reviews were conducted for 4 key questions regarding the surgical treatment of GERD in both adults and children: surgical vs. medical treatment, robotic vs. laparoscopic fundoplication, partial vs. complete fundoplication, and division vs. preservation of short gastric vessels in adults or maximal versus minimal dissection in pediatric patients. Evidence-based recommendations were formulated using the GRADE methodology by subject experts. Recommendations for future research were also proposed.

Results: The panel provided seven recommendations for adults and children with GERD. All recommendations were conditional due to very low, low, or moderate certainty of evidence. The panel conditionally recommended surgical treatment over medical management for adults with chronic or chronic refractory GERD. There was insufficient evidence for the panel to make a recommendation regarding surgical versus medical treatment in children. The panel suggested that once the decision to pursue surgical therapy is made, adults and children with GERD may be treated with either a robotic or a laparoscopic approach, and either partial or complete fundoplication based on surgeon-patient shared decision-making and patient values. In adults, the panel suggested either division or non-division of the short gastric vessels is appropriate, and that children should undergo minimal dissection during fundoplication.

Conclusions: These recommendations should provide guidance with regard to surgical decision-making in the treatment of GERD and highlight the importance of shared decision-making and patient values to optimize patient outcomes. Pursuing the identified research needs may improve future versions of guidelines for the treatment of GERD.
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http://dx.doi.org/10.1007/s00464-021-08625-5DOI Listing
September 2021

Customized guidance/training improved the psychometric properties of methodologically rigorous risk of bias instruments for non-randomized studies.

J Clin Epidemiol 2021 Aug 9;136:157-167. Epub 2021 May 9.

George & Fay Yee Center for Healthcare Innovation, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba. R3E 0T6, Canada; Department of Community Health Sciences, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, R3E 0T6, Canada.

Objectives: To evaluate the impact of guidance and training on the inter-rater reliability (IRR), inter-consensus reliability (ICR) and evaluator burden of the Risk of Bias (RoB) in Non-randomized Studies (NRS) of Interventions (ROBINS-I) tool, and the RoB instrument for NRS of Exposures (ROB-NRSE).

Study Design And Setting: In a before-and-after study, seven reviewers appraised the RoB using ROBINS-I (n = 44) and ROB-NRSE (n = 44), before and after guidance and training. We used Gwet's AC statistic to calculate IRR and ICR.

Results: After guidance and training, the IRR and ICR of the overall bias domain of ROBINS-I and ROB-NRSE improved significantly; with many individual domains showing either a significant (IRR and ICR of ROB-NRSE; ICR of ROBINS-I), or nonsignificant improvement (IRR of ROBINS-I). Evaluator burden significantly decreased after guidance and training for ROBINS-I, whereas for ROB-NRSE there was a slight nonsignificant increase.

Conclusion: Overall, there was benefit for guidance and training for both tools. We highly recommend guidance and training to reviewers prior to RoB assessments and that future research investigate aspects of guidance and training that are most effective.
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http://dx.doi.org/10.1016/j.jclinepi.2021.04.017DOI Listing
August 2021

Giant Cell Tumor of Triquetrum: A Case Report with Literature Review.

J Wrist Surg 2021 Apr 13;10(2):158-163. Epub 2020 Jul 13.

Department of Orthopaedics, All India Institute of Medical Sciences, New Delhi, India.

 Giant cell tumor (GCT) of bone is a benign, aggressive tumor of bone and occurs commonly around the knee and distal radius. GCT of bone rarely occurs in hand. In hand, metacarpals are the most common site and there have been only a few case reports of GCT of the carpal bone. In hand, these tumors are very aggressive and these have a high tendency to recur after intralesional curettage. No long-term study is available for choosing an appropriate method of treatment for these tumors in hand.  Herein, we report a case of GCT of the bone involving triquetrum which was managed by excision of triquetrum and scaphoid bone. The reconstruction of the wrist was done through limited carpal fusion, by doing three corner fusion of the wrist. At 2 years after surgery, the patient was asymptomatic and radiographs revealed fusion of lunocapitate and lunohamate joints with no evidence of recurrence.  Current literature regarding GCT of triquetrum includes case reports that are reviewed in this report.  This case illustrates the successful treatment of GCT of triquetrum, which is a rare tumor. Three-corner fusion is a reliable and reproducible procedure that has been used for other arthritic conditions. The use of three corner fusion procedure can be extended to GCT of carpal bones. It has been a motion-preserving alternative to proximal row carpectomy.
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http://dx.doi.org/10.1055/s-0040-1713903DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8012084PMC
April 2021

SAGES guidelines for the use of peroral endoscopic myotomy (POEM) for the treatment of achalasia.

Surg Endosc 2021 05 9;35(5):1931-1948. Epub 2021 Feb 9.

Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.

Background: Peroral endoscopic myotomy (POEM) is increasingly used as primary treatment for esophageal achalasia, in place of the options such as Heller myotomy (HM) and pneumatic dilatation (PD) OBJECTIVE: These evidence-based guidelines from the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) intend to support clinicians, patients and others in decisions about the use of POEM for treatment of achalasia.

Results: The panel agreed on 4 recommendations for adults and children with achalasia.

Conclusions: Strong recommendation for the use of POEM over PD was issued unless the concern of continued postoperative PPI use remains a key decision-making concern to the patient. Conditional recommendations included the option of using either POEM or HM with fundoplication to treat achalasia, and favored POEM over HM for achalasia subtype III.
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http://dx.doi.org/10.1007/s00464-020-08282-0DOI Listing
May 2021

Developing trustworthy recommendations as part of an urgent response (1-2 weeks): a GRADE concept paper.

J Clin Epidemiol 2021 01 30;129:1-11. Epub 2020 Sep 30.

American College of Physicians, 190 N Independence Mall West, Philadelphia, PA 19087, USA.

Objectives: The aim of this study is to propose an approach for developing trustworthy recommendations as part of urgent responses (1-2 week) in the clinical, public health, and health systems fields.

Study Design And Setting: We conducted a review of the literature, outlined a draft approach, refined the concept through iterative discussions, a workshop by the Grading of Recommendations Assessment, Development and Evaluation Rapid Guidelines project group, and obtained feedback from the larger Grading of Recommendations Assessment, Development and Evaluation working group.

Results: A request for developing recommendations within 2 week is the usual trigger for an urgent response. Although the approach builds on the general principles of trustworthy guideline development, we highlight the following steps: (1) assess the level of urgency; (2) assess feasibility; (3) set up the organizational logistics; (4) specify the question(s); (5) collect the information needed; (6) assess the adequacy of identified information; (7) develop the recommendations using one of the 4 potential approaches: adopt existing recommendations, adapt existing recommendations, develop new recommendations using existing adequate systematic review, or develop new recommendations using expert panel input; and (8) consider an updating plan.

Conclusion: An urgent response for developing recommendations requires building a cohesive, skilled, and highly motivated multidisciplinary team with the necessary clinical, scientific, and methodological expertise; adapting to shifting needs; complying with the principles of transparency; and properly managing conflicts of interest.
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http://dx.doi.org/10.1016/j.jclinepi.2020.09.037DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7526592PMC
January 2021

Methodologically rigorous risk of bias tools for nonrandomized studies had low reliability and high evaluator burden.

J Clin Epidemiol 2020 12 25;128:140-147. Epub 2020 Sep 25.

George & Fay Yee Center for Healthcare Innovation, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba R3E 0T6, Canada; Department of Community Health Sciences, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba R3E 0T6, Canada.

Objective: To assess the real-world interrater reliability (IRR), interconsensus reliability (ICR), and evaluator burden of the Risk of Bias (RoB) in Nonrandomized Studies (NRS) of Interventions (ROBINS-I), and the ROB Instrument for NRS of Exposures (ROB-NRSE) tools.

Study Design And Setting: A six-center cross-sectional study with seven reviewers (2 reviewer pairs) assessing the RoB using ROBINS-I (n = 44 NRS) or ROB-NRSE (n = 44 NRS). We used Gwet's AC statistic to calculate the IRR and ICR. To measure the evaluator burden, we assessed the total time taken to apply the tool and reach a consensus.

Results: For ROBINS-I, both IRR and ICR for individual domains ranged from poor to substantial agreement. IRR and ICR on overall RoB were poor. The evaluator burden was 48.45 min (95% CI 45.61 to 51.29). For ROB-NRSE, the IRR and ICR for the majority of domains were poor, while the rest ranged from fair to perfect agreement. IRR and ICR on overall RoB were slight and poor, respectively. The evaluator burden was 36.98 min (95% CI 34.80 to 39.16).

Conclusions: We found both tools to have low reliability, although ROBINS-I was slightly higher. Measures to increase agreement between raters (e.g., detailed training, supportive guidance material) may improve reliability and decrease evaluator burden.
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http://dx.doi.org/10.1016/j.jclinepi.2020.09.033DOI Listing
December 2020

Safe Cholecystectomy Multi-society Practice Guideline and State of the Art Consensus Conference on Prevention of Bile Duct Injury During Cholecystectomy.

Ann Surg 2020 07;272(1):3-23

Indiana University School of Medicine, Indianapolis, IN.

Background: BDI is the most common serious complication of laparoscopic cholecystectomy. To address this problem, a multi-society consensus conference was held to develop evidenced-based recommendations for safe cholecystectomy and prevention of BDI.

Methods: Literature reviews were conducted for 18 key questions across 6 broad topics around cholecystectomy directed by a steering group and subject experts from 5 surgical societies (Society of Gastrointestinal and Endoscopic Surgeons, Americas Hepato-Pancreato-Biliary Association, International Hepato-Pancreato-Biliary Association, Society for Surgery of the Alimentary Tract, and European Association for Endoscopic Surgery). Evidence-based recommendations were formulated using the grading of recommendations assessment, development, and evaluation methodology. When evidence-based recommendations could not be made, expert opinion was documented. A number of recommendations for future research were also documented. Recommendations were presented at a consensus meeting in October 2018 and were voted on by an international panel of 25 experts with greater than 80% agreement considered consensus.

Results: Consensus was reached on 17 of 18 questions by the guideline development group and expert panel with high concordance from audience participation. Most recommendations were conditional due to low certainty of evidence. Strong recommendations were made for (1) use of intraoperative biliary imaging for uncertainty of anatomy or suspicion of biliary injury; and (2) referral of patients with confirmed or suspected BDI to an experienced surgeon/multispecialty hepatobiliary team.

Conclusions: These consensus recommendations should provide guidance to surgeons, training programs, hospitals, and professional societies for strategies that have the potential to reduce BDIs and positively impact patient outcomes. Development of clinical and educational research initiatives based on these recommendations may drive further improvement in the quality of surgical care for patients undergoing cholecystectomy.
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http://dx.doi.org/10.1097/SLA.0000000000003791DOI Listing
July 2020

Safe cholecystectomy multi-society practice guideline and state-of-the-art consensus conference on prevention of bile duct injury during cholecystectomy.

Surg Endosc 2020 07 12;34(7):2827-2855. Epub 2020 May 12.

Indiana University School of Medicine, Indianapolis, IN, USA.

Background: Bile duct injury (BDI) is the most common serious complication of laparoscopic cholecystectomy. To address this problem, a multi-society consensus conference was held to develop evidenced-based recommendations for safe cholecystectomy and prevention of BDI.

Methods: Literature reviews were conducted for 18 key questions across six broad topics around cholecystectomy directed by a steering group and subject experts from five surgical societies (SAGES, AHPBA IHPBA, SSAT, and EAES). Evidence-based recommendations were formulated using the GRADE methodology. When evidence-based recommendations could not be made, expert opinion was documented. A number of recommendations for future research were also documented. Recommendations were presented at a consensus meeting in October 2018 and were voted on by an international panel of 25 experts with greater than 80% agreement considered consensus.

Results: Consensus was reached on 17 of 18 questions by the Guideline Development Group (GDG) and expert panel with high concordance from audience participation. Most recommendations were conditional due to low certainty of evidence. Strong recommendations were made for (1) use of intraoperative biliary imaging for uncertainty of anatomy or suspicion of biliary injury; and (2) referral of patients with confirmed or suspected BDI to an experienced surgeon/multispecialty hepatobiliary team.

Conclusion: These consensus recommendations should provide guidance to surgeons, training programs, hospitals, and professional societies for strategies that have the potential to reduce BDIs and positively impact patient outcomes. Development of clinical and educational research initiatives based on these recommendations may drive further improvement in the quality of surgical care for patients undergoing cholecystectomy.
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http://dx.doi.org/10.1007/s00464-020-07568-7DOI Listing
July 2020

GRADE guidelines: 21 part 1. Study design, risk of bias, and indirectness in rating the certainty across a body of evidence for test accuracy.

J Clin Epidemiol 2020 06 12;122:129-141. Epub 2020 Feb 12.

Department of Epidemiology, Biostatistics and Occupational Health, McGill University, 1650 Cedar Avenue, Montreal, Quebec H3G 1A4, Canada.

Objectives: This article provides updated GRADE guidance about how authors of systematic reviews and health technology assessments and guideline developers can assess the results and the certainty of evidence (also known as quality of the evidence or confidence in the estimates) of a body of evidence addressing test accuracy (TA).

Study Design And Setting: We present an overview of the GRADE approach and guidance for rating certainty in TA in clinical and public health and review the presentation of results of a body of evidence regarding tests. Part 1 of the two parts in this 21st guidance article about how to apply GRADE focuses on understanding study design issues in test accuracy, provide an overview of the domains, and describe risk of bias and indirectness specifically.

Results: Supplemented by practical examples, we describe how raters of the evidence using GRADE can evaluate study designs focusing on tests and how they apply the GRADE domains risk of bias and indirectness to a body of evidence of TA studies.

Conclusion: Rating the certainty of a body of evidence using GRADE in Cochrane and other reviews and World Health Organization and other guidelines dealing with in TA studies helped refining our approach. The resulting guidance will help applying GRADE successfully for questions and recommendations focusing on tests.
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http://dx.doi.org/10.1016/j.jclinepi.2019.12.020DOI Listing
June 2020

GRADE guidelines: 21 part 2. Test accuracy: inconsistency, imprecision, publication bias, and other domains for rating the certainty of evidence and presenting it in evidence profiles and summary of findings tables.

J Clin Epidemiol 2020 06 10;122:142-152. Epub 2020 Feb 10.

Department of Epidemiology, Biostatistics and Occupational Health, McGill University, 1650 Cedar Ave, Montreal, Quebec H3G 1A4, Canada.

Objectives: This article provides updated GRADE guidance about how authors of systematic reviews and health technology assessments and guideline developers can rate the certainty of evidence (also known as quality of the evidence or confidence in the estimates) of a body of evidence addressing test accuracy (TA) on the domains imprecision, inconsistency, publication bias, and other domains. It also provides guidance for how to present synthesized information in evidence profiles and summary of findings tables.

Study Design And Setting: We present guidance for rating certainty in TA in clinical and public health and review the presentation of results of a body of evidence regarding tests.

Results: Supplemented by practical examples, we describe how raters of the evidence can apply the GRADE domains inconsistency, imprecision, and publication bias to a body of evidence of TA studies.

Conclusion: Using GRADE in Cochrane and other reviews as well as World Health Organization and other guidelines helped refining the GRADE approach for rating the certainty of a body of evidence from TA studies. Although several of the GRADE domains (e.g., imprecision and magnitude of the association) require further methodological research to help operationalize them, judgments need to be made on the basis of what is known so far.
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http://dx.doi.org/10.1016/j.jclinepi.2019.12.021DOI Listing
June 2020

Inter-rater reliability and validity of risk of bias instrument for non-randomized studies of exposures: a study protocol.

Syst Rev 2020 02 12;9(1):32. Epub 2020 Feb 12.

The George & Fay Yee Center for Healthcare Innovation, University of Manitoba, 363-753 McDermot Avenue, Winnipeg, Manitoba, R3E 0 T6, Canada.

Background: A new tool, "risk of bias (ROB) instrument for non-randomized studies of exposures (ROB-NRSE)," was recently developed. It is important to establish consistency in its application and interpretation across review teams. In addition, it is important to understand if specialized training and guidance will improve the reliability in the results of the assessments. Therefore, the objective of this cross-sectional study is to establish the inter-rater reliability (IRR), inter-consensus reliability (ICR), and concurrent validity of the new ROB-NRSE tool. Furthermore, as this is a relatively new tool, it is important to understand the barriers to using this tool (e.g., time to conduct assessments and reach consensus-evaluator burden).

Methods: Reviewers from four participating centers will apprise the ROB of a sample of NRSE publications using ROB-NRSE tool in two stages. For IRR and ICR, two pairs of reviewers will assess the ROB for each NRSE publication. In the first stage, reviewers will assess the ROB without any formal guidance. In the second stage, reviewers will be provided customized training and guidance. At each stage, each pair of reviewers will resolve conflicts and arrive at a consensus. To calculate the IRR and ICR, we will use Gwet's AC statistic. For concurrent validity, reviewers will appraise a sample of NRSE publications using both the Newcastle-Ottawa Scale (NOS) and ROB-NRSE tool. We will analyze the concordance between the two tools for similar domains and for the overall judgments using Kendall's tau coefficient. To measure evaluator burden, we will assess the time taken to apply ROB-NRSE tool (without and with guidance), and the NOS. To assess the impact of customized training and guidance on the evaluator burden, we will use the generalized linear models. We will use Microsoft Excel and SAS 9.4, to manage and analyze study data, respectively.

Discussion: The quality of evidence from systematic reviews that include NRSE depends partly on the study-level ROB assessments. The findings of this study will contribute to an improved understanding of ROB-NRSE and how best to use it.
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http://dx.doi.org/10.1186/s13643-020-01291-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7017505PMC
February 2020

Inter-rater reliability and concurrent validity of ROBINS-I: protocol for a cross-sectional study.

Syst Rev 2020 01 13;9(1):12. Epub 2020 Jan 13.

The George and Fay Yee Center for Healthcare Innovation, University of Manitoba, 753 McDermot Avenue, Winnipeg, MB, R3E 0T6, Canada.

Background: The Cochrane Bias Methods Group recently developed the "Risk of Bias (ROB) in Non-randomized Studies of Interventions" (ROBINS-I) tool to assess ROB for non-randomized studies of interventions (NRSI). It is important to establish consistency in its application and interpretation across review teams. In addition, it is important to understand if specialized training and guidance will improve the reliability of the results of the assessments. Therefore, the objective of this cross-sectional study is to establish the inter-rater reliability (IRR), inter-consensus reliability (ICR), and concurrent validity of ROBINS-I. Furthermore, as this is a relatively new tool, it is important to understand the barriers to using this tool (e.g., time to conduct assessments and reach consensus-evaluator burden).

Methods: Reviewers from four participating centers will appraise the ROB of a sample of NRSI publications using the ROBINS-I tool in two stages. For IRR and ICR, two pairs of reviewers will assess the ROB for each NRSI publication. In the first stage, reviewers will assess the ROB without any formal guidance. In the second stage, reviewers will be provided customized training and guidance. At each stage, each pair of reviewers will resolve conflicts and arrive at a consensus. To calculate the IRR and ICR, we will use Gwet's AC statistic. For concurrent validity, reviewers will appraise a sample of NRSI publications using both the New-castle Ottawa Scale (NOS) and ROBINS-I. We will analyze the concordance between the two tools for similar domains and for the overall judgments using Kendall's tau coefficient. To measure the evaluator burden, we will assess the time taken to apply the ROBINS-I (without and with guidance), and the NOS. To assess the impact of customized training and guidance on the evaluator burden, we will use the generalized linear models. We will use Microsoft Excel and SAS 9.4 to manage and analyze study data, respectively.

Discussion: The quality of evidence from systematic reviews that include NRS depends partly on the study-level ROB assessments. The findings of this study will contribute to an improved understanding of the ROBINS-I tool and how best to use it.
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http://dx.doi.org/10.1186/s13643-020-1271-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6958722PMC
January 2020

Neurological and psychiatric adverse effects of long-term methylphenidate treatment in ADHD: A map of the current evidence.

Neurosci Biobehav Rev 2019 12 20;107:945-968. Epub 2019 Sep 20.

Division of Psychiatry & Applied Psychology, School of Medicine, Institute of Mental Health, University of Nottingham, UK. Electronic address:

Methylphenidate (MPH), the most common medication for children with Attention Deficit/Hyperactivity Disorder (ADHD) in many countries, is often prescribed for long periods of time. Any long-term psychotropic treatment in childhood raises concerns about possible adverse neurological and psychiatric outcomes. We aimed to map current evidence regarding neurological and psychiatric outcomes, adverse or beneficial, of long-term MPH (> 1 year) treatment in ADHD. We coded studies using a "traffic light" system: Green: safe/favours MPH; Amber: warrants caution; Red: not safe/not well-tolerated. Un-categorisable study findings were coded as "Unclear". Although some evidence suggests an elevated risk of psychosis and tics, case reports describe remission on discontinuation. Several studies suggest that long-term MPH may reduce depression and suicide in ADHD. Evidence suggests caution in specific groups including pre-school children, those with tics, and adolescents at risk for substance misuse. We identified a need for more studies that make use of large longitudinal databases, focus on specific neuropsychiatric outcomes, and compare outcomes from long-term MPH treatment with outcomes following shorter or no pharmacological intervention.
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http://dx.doi.org/10.1016/j.neubiorev.2019.09.023DOI Listing
December 2019

The incidence and prevalence of delirium across palliative care settings: A systematic review.

Palliat Med 2019 09 11;33(8):865-877. Epub 2019 Jun 11.

1 Division of Palliative Care, Department of Medicine, University of Ottawa, Ottawa, ON, Canada.

Background: Delirium is a common and distressing neurocognitive condition that frequently affects patients in palliative care settings and is often underdiagnosed.

Aim: Expanding on a 2013 review, this systematic review examines the incidence and prevalence of delirium across all palliative care settings.

Design: This systematic review and meta-analyses were prospectively registered with PROSPERO and included a risk of bias assessment.

Data Sources: Five electronic databases were examined for primary research studies published between 1980 and 2018. Studies on adult, non-intensive care and non-postoperative populations, either receiving or eligible to receive palliative care, underwent dual reviewer screening and data extraction. Studies using standardized delirium diagnostic criteria or valid assessment tools were included.

Results: Following initial screening of 2596 records, and full-text screening of 153 papers, 42 studies were included. Patient populations diagnosed with predominantly cancer ( = 34) and mixed diagnoses ( = 8) were represented. Delirium point prevalence estimates were 4%-12% in the community, 9%-57% across hospital palliative care consultative services, and 6%-74% in inpatient palliative care units. The prevalence of delirium prior to death across all palliative care settings ( = 8) was 42%-88%. Pooled point prevalence on admission to inpatient palliative care units was 35% (confidence interval = 0.29-0.40,  = 14). Only one study had an overall low risk of bias. Varying delirium screening and diagnostic practices were used.

Conclusion: Delirium is prevalent across all palliative care settings, with one-third of patients delirious at the time of admission to inpatient palliative care. Study heterogeneity limits meta-analyses and highlights the future need for rigorous studies.
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http://dx.doi.org/10.1177/0269216319854944DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6691600PMC
September 2019

Defining ranges for certainty ratings of diagnostic accuracy: a GRADE concept paper.

J Clin Epidemiol 2020 01 18;117:138-148. Epub 2019 May 18.

Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada; Department of Medicine, Michael G DeGroote Cochrane Canada Centre and GRADE centre, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada.

Objective: The objective of the study was to clarify how the Grading of Recommendations Assessment, Development and Evaluation (GRADE) concept of certainty of evidence applies to certainty ratings of test accuracy.

Study Design And Setting: After initial brainstorming with GRADE Working Group members, we iteratively refined and clarified the approaches for defining ranges when assessing the certainty of evidence for test accuracy within a systematic review, health technology assessment, or guideline.

Results: Ranges can be defined both for single test accuracy and for comparative accuracy of multiple tests. For systematic reviews and health technology assessments, approaches for defining ranges include some that do not require value judgments regarding downstream health outcomes. Key challenges arise in the context of a guideline that requires ranges for sensitivity and specificity that are set considering possible effects on all critical outcomes. We illustrate possible approaches and provide an example from a systematic review of a direct comparison between two test strategies.

Conclusions: This GRADE concept paper provides a framework for assessing, presenting, and making decisions based on the certainty of evidence for test accuracy. More empirical research is needed to support future GRADE guidance on how to best operationalize the candidate approaches.
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http://dx.doi.org/10.1016/j.jclinepi.2019.05.002DOI Listing
January 2020

Corrigendum: Predicting Outcomes From Radical Radiotherapy for Non-small Cell Lung Cancer: A Systematic Review of the Existing Literature.

Front Oncol 2019 1;9:112. Epub 2019 Mar 1.

Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.

[This corrects the article DOI: 10.3389/fonc.2018.00433.].
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http://dx.doi.org/10.3389/fonc.2019.00112DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6405640PMC
March 2019

A Scoping Review to Map Empirical Evidence Regarding Key Domains and Questions in the Clinical Pathway of Delirium in Palliative Care.

J Pain Symptom Manage 2019 03 12;57(3):661-681.e12. Epub 2018 Dec 12.

Division of Palliative Care, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada; Bruyère Continuing Care, Ottawa, Ontario, Canada; Bruyère Research Institute, Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.

Context: Based on the clinical care pathway of delirium in palliative care (PC), a published analytic framework (AF) formulated research questions in key domains and recommended a scoping review to identify evidence gaps.

Objectives: To produce a literature map for key domains of the published AF: screening, prognosis and diagnosis, management, and the health-related outcomes.

Methods: A standard scoping review framework was used by an interdisciplinary study team of nurse- and physician-delirium researchers, an information specialist, and review methodologists to conduct the review. Knowledge user engagement provided context in refining 19 AF questions. A peer-reviewed search strategy identified citations in Medline, PsycINFO, Embase, and CINAHL databases between 1980 and 2018. Two reviewers independently screened records for inclusion using explicit study eligibility criteria for the population, design, delirium diagnosis, and investigational intent.

Results: Of 104 studies reporting empirical data and meeting eligibility criteria, most were conducted in patients with cancer (73.1%) and in inpatient PC units (52%). The most frequent study design was a one or more group, nonrandomized trial or cohort (67.3%). Evidence gaps were identified: delirium risk prediction; comparative effectiveness and harms of prevention, variability in delirium management across PC settings, advanced directive and substitute decision-maker input, and transition of care location; and estimating delirium reversibility. Future rigorous primary studies are required to address these gaps and preliminary concerns regarding the quality of extant literature.

Conclusion: Substantial evidence gaps exist, providing opportunities for future research regarding the assessment, prognosis, and management of delirium in PC settings.
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http://dx.doi.org/10.1016/j.jpainsymman.2018.12.002DOI Listing
March 2019

Predicting Outcomes From Radical Radiotherapy for Non-small Cell Lung Cancer: A Systematic Review of the Existing Literature.

Front Oncol 2018 10;8:433. Epub 2018 Oct 10.

Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.

Radical radiotherapy (RT) is a potentially curative treatment in non-small cell lung cancer (NSCLC) and is delivered in conventional 2-Gy fractions, hypofractionated and ablative stereotactic courses. No reliable, predictive biomarkers for the clinical events of local control, appearance of distant metastases and development of toxicity have been introduced in routine clinical practice. Such a test would enable the Radiotherapist to tailor the clinical management of individual patients, considering their pre-treatment characteristics, in order reduce the risk of recurrence or toxicity e.g., dose modification, accelerated fractionation, hypofractionation, or concurrent systemic therapy. The aim of this review was to map the published literature relating to investigations of the potential predictive value of patient or treatment characteristics in radical RT for NSCLC. These investigations should remain a research focus for disease control given the upward trends in lung cancer incidence, and for the avoidance of toxicity, given the survivorship afforded to the cohort of patients that do well with radical RT, or with the increasing range of systemic agents following metastatic relapse. The conclusion of the presented analysis is that there are no published, effective and validated predictive tools for estimation of risk of local/distant recurrence or toxicity after radical RT for NSCLC. The authors have identified an important space for future research in the field of lung cancer radiotherapy.
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http://dx.doi.org/10.3389/fonc.2018.00433DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6191477PMC
October 2018

AHRQ series on complex intervention systematic reviews-paper 3: adapting frameworks to develop protocols.

J Clin Epidemiol 2017 Oct 15;90:19-27. Epub 2017 Jul 15.

Scientific Resource Center for the AHRQ Effective Health Care Program, Division of Maternal Fetal Medicine, Department of Obstetrics & Gynecology, Department of Public Health & Preventive Medicine, Department of Medical Informatics & Clinical Epidemiology, Department of Emergency Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR, USA.

Background: Once a proposed topic has been identified for a systematic review and has undergone a question formulation stage, a protocol must be developed that specifies the scope and research questions in detail and outlines the methodology for conducting the systematic review.

Rationale: Framework modifications are often needed to accommodate increased complexity. We describe and give examples of adaptations and alternatives to traditional analytic frameworks.

Discussion: This article identifies and describes elements of frameworks and how they can be adapted to inform the protocol and conduct of systematic reviews of complex interventions. Modifications may be needed to adapt the population, intervention, comparators, and outcomes normally used in protocol development to successfully describe complex interventions; in some instances, alternative frameworks may be better suited. Possible approaches to analytic frameworks for complex interventions that illustrate causal and associative linkages are outlined, including time elements, which systematic reviews of complex interventions may need to address. The need for and specifics of the accommodations vary with details of a specific systematic review. This in turn helps determine whether traditional frameworks are sufficient, can be refined, or if alternate frameworks must be adopted.
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http://dx.doi.org/10.1016/j.jclinepi.2017.06.013DOI Listing
October 2017

The GRADE Working Group clarifies the construct of certainty of evidence.

J Clin Epidemiol 2017 Jul 18;87:4-13. Epub 2017 May 18.

Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada; Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada.

Objective: To clarify the grading of recommendations assessment, development and evaluation (GRADE) definition of certainty of evidence and suggest possible approaches to rating certainty of the evidence for systematic reviews, health technology assessments, and guidelines.

Study Design And Setting: This work was carried out by a project group within the GRADE Working Group, through brainstorming and iterative refinement of ideas, using input from workshops, presentations, and discussions at GRADE Working Group meetings to produce this document, which constitutes official GRADE guidance.

Results: Certainty of evidence is best considered as the certainty that a true effect lies on one side of a specified threshold or within a chosen range. We define possible approaches for choosing threshold or range. For guidelines, what we call a fully contextualized approach requires simultaneously considering all critical outcomes and their relative value. Less-contextualized approaches, more appropriate for systematic reviews and health technology assessments, include using specified ranges of magnitude of effect, for example, ranges of what we might consider no effect, trivial, small, moderate, or large effects.

Conclusion: It is desirable for systematic review authors, guideline panelists, and health technology assessors to specify the threshold or ranges they are using when rating the certainty in evidence.
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http://dx.doi.org/10.1016/j.jclinepi.2017.05.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6542664PMC
July 2017

GRADE equity guidelines 1: considering health equity in GRADE guideline development: introduction and rationale.

J Clin Epidemiol 2017 Oct 12;90:59-67. Epub 2017 Apr 12.

Department of Medicine, University of Ottawa, Faculty of Medicine, Ottawa, Canada K1H 8M5.

Objectives: This article introduces the rationale and methods for explicitly considering health equity in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology for development of clinical, public health, and health system guidelines.

Study Design And Setting: We searched for guideline methodology articles, conceptual articles about health equity, and examples of guidelines that considered health equity explicitly. We held three meetings with GRADE Working Group members and invited comments from the GRADE Working Group listserve.

Results: We developed three articles on incorporating equity considerations into the overall approach to guideline development, rating certainty, and assembling the evidence base and evidence to decision and/or recommendation.

Conclusion: Clinical and public health guidelines have a role to play in promoting health equity by explicitly considering equity in the process of guideline development.
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http://dx.doi.org/10.1016/j.jclinepi.2017.01.014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5675012PMC
October 2017

GRADE equity guidelines 3: considering health equity in GRADE guideline development: rating the certainty of synthesized evidence.

J Clin Epidemiol 2017 Oct 4;90:76-83. Epub 2017 Apr 4.

IHCAI Foundation & Cochrane Central America & Spanish speaking Caribbean, Av 7. calles 35 y 37, No 35 30, Codigo Postal 10106, San Jose, Costa Rica.

Objectives: The aim of this paper is to describe a conceptual framework for how to consider health equity in the Grading Recommendations Assessment and Development Evidence (GRADE) guideline development process.

Study Design And Setting: Consensus-based guidance developed by the GRADE working group members and other methodologists.

Results: We developed consensus-based guidance to help address health equity when rating the certainty of synthesized evidence (i.e., quality of evidence). When health inequity is determined to be a concern by stakeholders, we propose five methods for explicitly assessing health equity: (1) include health equity as an outcome; (2) consider patient-important outcomes relevant to health equity; (3) assess differences in the relative effect size of the treatment; (4) assess differences in baseline risk and the differing impacts on absolute effects; and (5) assess indirectness of evidence to disadvantaged populations and/or settings.

Conclusion: The most important priority for research on health inequity and guidelines is to identify and document examples where health equity has been considered explicitly in guidelines. Although there is a weak scientific evidence base for assessing health equity, this should not discourage the explicit consideration of how guidelines and recommendations affect the most vulnerable members of society.
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http://dx.doi.org/10.1016/j.jclinepi.2017.01.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5680526PMC
October 2017

Methods for Developing Evidence Reviews in Short Periods of Time: A Scoping Review.

PLoS One 2016 8;11(12):e0165903. Epub 2016 Dec 8.

World Health Organization, Geneva, Republic and Canton of Geneva, Switzerland.

Introduction: Rapid reviews (RR), using abbreviated systematic review (SR) methods, are becoming more popular among decision-makers. This World Health Organization commissioned study sought to summarize RR methods, identify differences, and highlight potential biases between RR and SR.

Methods: Review of RR methods (Key Question 1 [KQ1]), meta-epidemiologic studies comparing reliability/ validity of RR and SR methods (KQ2), and their potential associated biases (KQ3). We searched Medline, EMBASE, Cochrane Library, grey literature, and checked reference lists, used personal contacts, and crowdsourcing (e.g. email listservs). Selection and data extraction was conducted by one reviewer (KQ1) or two reviewers independently (KQ2-3).

Results: Across all KQs, we identified 42,743 citations through the literature searches. KQ1: RR methods from 29 organizations were reviewed. There was no consensus on which aspects of the SR process to abbreviate. KQ2: Studies comparing the conclusions of RR and SR (n = 9) found them to be generally similar. Where major differences were identified, it was attributed to the inclusion of evidence from different sources (e.g. searching different databases or including different study designs). KQ3: Potential biases introduced into the review process were well-identified although not necessarily supported by empirical evidence, and focused mainly on selective outcome reporting and publication biases.

Conclusion: RR approaches are context and organization specific. Existing comparative evidence has found similar conclusions derived from RR and SR, but there is a lack of evidence comparing the potential of bias in both evidence synthesis approaches. Further research and decision aids are needed to help decision makers and reviewers balance the benefits of providing timely evidence with the potential for biased findings.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0165903PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5145149PMC
July 2017

Perioperative Diastolic Dysfunction in Patients Undergoing Noncardiac Surgery Is an Independent Risk Factor for Cardiovascular Events: A Systematic Review and Meta-analysis.

Anesthesiology 2016 Jul;125(1):72-91

From the Department of Anesthesiology, University of Ottawa, The Ottawa Hospital, Ottawa, Ontario, Canada (A.F., H.Y.); School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Faculty of Medicine, Ottawa, Ontario, Canada (M.T.A.); Department of Cardiology and Nuclear Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada (T.R.); and Department of Epidemiology and Community Medicine, Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Ottawa, Ontario, Canada (G.A.W.).

Background: The prognostic value of perioperative diastolic dysfunction (PDD) in patients undergoing noncardiac surgery remains uncertain, and the current guidelines do not recognize PDD as a perioperative risk factor. This systematic review aimed to investigate whether existing evidence supports PDD as an independent predictor of adverse events after noncardiac surgery.

Methods: Ovid MEDLINE, PubMed, EMBASE, the Cochrane Library, and Google search engine were searched for English-language citations in April 2015 investigating PDD as a risk factor for perioperative adverse events in adult patients undergoing noncardiac surgery. Two reviewers independently assessed the study risk of bias. Extracted data were verified. Random-effects model was used for meta-analysis, and reviewers' certainty was graded.

Results: Seventeen studies met eligibility criteria; however, 13 contributed to evidence synthesis. The entire body of evidence addressing the research question was based on a total of 3,876 patients. PDD was significantly associated with pulmonary edema/congestive heart failure (odds ratio [OR], 3.90; 95% CI, 2.23 to 6.83; 3 studies; 996 patients), myocardial infarction (OR, 1.74; 95% CI, 1.14 to 2.67; 3 studies; 717 patients), and the composite outcome of major adverse cardiovascular events (OR, 2.03; 95% CI, 1.24 to 3.32; 4 studies; 1,814 patients). Evidence addressing other outcomes had low statistical power, but higher long-term cardiovascular mortality was observed in patients undergoing open vascular repair (OR, 3.00; 95% CI, 1.50 to 6.00). Reviewers' overall certainty of the evidence was moderate.

Conclusion: Evidence of moderate certainty indicates that PDD is an independent risk factor for adverse cardiovascular outcomes after noncardiac surgery.
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http://dx.doi.org/10.1097/ALN.0000000000001132DOI Listing
July 2016

Intrathecal Analgesia for Chronic Refractory Pain: Current and Future Prospects.

Drugs 2015 Nov;75(17):1957-80

Faculty of Medicine, School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, ON, Canada.

The intrathecal drug-delivery system (IDDS) is one mode of infusing analgesic medications directly into the cerebrospinal fluid in close proximity to their site of action. This modality has been employed in patients with refractory pain either due to malignant or non-malignant causes for over 30 years. Unfortunately, and despite the number of years it has been in use, there is still a scarcity of rigorous evidence to guide its integration into clinical practice. Current best evidence is inconclusive as to the comparative effectiveness and harms of the IDDS relative to routine medical care of patients. There are far more systematic reviews than high-quality primary comparative studies of the IDDS vs. conventional pain treatment. Existing clinical practice recommendations are best viewed as expert opinion with competing interests. This article will review the existing literature for indications, contraindications, consensus statements, different technologies, and complications of the IDDS. Although approved analgesics for IDDS delivery are limited to morphine and ziconotide, many other analgesics, alone or in combination, are routinely used in this setting. This review will also focus on the pharmacology, clinical efficacy, and safety of intrathecal medications extensively used in clinical practice; including agents approved, unapproved, and under development.
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http://dx.doi.org/10.1007/s40265-015-0471-1DOI Listing
November 2015

Considerations from the risk of bias perspective for updating Cochrane reviews.

Syst Rev 2015 Oct 6;4:136. Epub 2015 Oct 6.

School of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Canada.

Authors of Cochrane reviews are expected to update their reviews every 2 years. The updating process helps to ensure that reviews are current and include recent evidence. However, the updating process is time-consuming for authors, particularly when Cochrane methods evolve and authors are required to revisit some of the originally included studies.The Cochrane Collaboration's 'Risk of bias' tool is a mandatory component of Cochrane reviews, providing an assessment of the potential biases of included studies. The tool has been modified most recently in 2011, and the expectation is that new versions will continue to be produced and utilised in all Cochrane reviews. In this commentary we discuss, in the context of updating scenarios that are likely to be encountered, the potential options systematic review authors may have recourse to when the Cochrane Collaboration's 'Risk of bias' tool has been modified between the original review and its update. We recommend that authors who are updating reviews should revise their original assessments of included studies using the most recent version of the risk of bias tool. Despite the increased workload, use of the most recent version of the tool facilitates consistency of methods and reporting both across and within reviews, and ensures currency to the methodological rigour.
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http://dx.doi.org/10.1186/s13643-015-0122-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4596509PMC
October 2015

Mitral Valve Clip for Treatment of Mitral Regurgitation: An Evidence-Based Analysis.

Ont Health Technol Assess Ser 2015 1;15(12):1-104. Epub 2015 May 1.

Ottawa Hospital Research Institute, Ottawa, Ontario.

Background: Many of the 500,000 North American patients with chronic mitral regurgitation may be poor candidates for mitral valve surgery.

Objective: The objective of this study was to investigate the comparative effectiveness, harms, and cost-effectiveness of percutaneous mitral valve repair using mitral valve clips in candidates at prohibitive risk for surgery.

Data Sources: We searched articles in MEDLINE, Embase, and the Cochrane Library published from 1994 to February 2014 for evidence of effectiveness and harms; for economic literature we also searched NHS EED and Tufts CEA registry. Grey literature was also searched.

Review Methods: Primary studies were sought from existing systematic reviews that had employed reliable search and screening methods. Newer studies were sought by searching the period subsequent to the last search date of the review. Two reviewers screened records and assessed study validity. We used the Cochrane risk of bias tool for randomized, generic assessment for non-randomized studies, and the Phillips checklist for economic studies.

Results: Ten studies including 1 randomized trial were included. The majority of the direct comparative evidence compared the mitral valve clip repair with surgery in patients not particularly at prohibitive surgical risk. Irrespective of degenerative or functional chronic mitral regurgitation etiology, evidence of effectiveness and harms is inconclusive and of very low quality. Very-low-quality evidence indicates that percutaneous mitral valve clip repair may provide a survival advantage, at least during the first 1 to 2 years, particularly in medically managed chronic functional mitral regurgitation. Because of limitations in the design of studies, the cost-effectiveness of mitral valve clips in patients at prohibitive risk for surgery also could not be established.

Limitations: Because of serious concerns of risk of bias, indirectness, and imprecision, evidence is of very low quality.

Conclusions: No meaningful conclusions can be drawn about the comparative effectiveness, harms, and cost-effectiveness of mitral valve clips in the population with chronic mitral regurgitation who are at prohibitive risk for surgery.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4561766PMC
June 2016

Comparative efficacy and safety of insulin analogs in hospitalized adults.

Am J Health Syst Pharm 2015 Apr;72(7):525-35

Kavita Singh, B.Sc.Phm., M.P.H., is Ph.D. Student, University of Ottawa, Ontario, Canada. Mohammed T. Ansari, M.B.B.S., M.Med. Sc., M.Phil., is Associate Investigator, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, and Adjunct Professor, Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa. Rakesh V. Patel, M.D. Pharm.D., is Director, Adult Critical Care Medicine Training Program, University of Ottawa, and Staff Intensivist, The Ottawa Hospital. Mario Bedard, B.Pharm., Pharm.D., is Director of Pharmacy, The Ottawa Hospital, Ottawa. Erin Keely, M.D., FRCPC, is Chief, Division of Endocrinology and Metabolism, The Ottawa Hospital, and Professor, Departments of Medicine and Obstetrics/Gynecology, University of Ottawa. Mike Tierney, B.Sc.Phm., M.Sc., is Vice President, Clinical Programs, The Ottawa Hospital. David Moher, Ph.D., is Senior Scientist, Ottawa Hospital Research Institute.

Purpose: The comparative efficacy, safety, and cost-effectiveness of rapid and long-acting insulin analogs compared with regular or neutral protamine Hagedorn nonanalog insulins or with oral antidiabetic agents in hospitalized adults were evaluated.

Methods: A literature search was conducted to identify studies that compared the effects of rapid-acting, long-acting, or mixed insulin analogs with short- or intermediate-acting insulin or any other oral antidiabetic medication.

Results: Twenty-three primary studies were included in the review. Rapid-acting analogs and basal-bolus analog regimens were found to reduce the duration of hospital stay by approximately one day compared with regular insulin and basal-bolus nonanalog regimens. One large cohort study found an adjusted 48% relative risk reduction in mortality with rapid-acting analogs versus regular insulin in a heterogeneous hospitalized hyperglycemic population. A randomized controlled trial found a significant reduction in postoperative complications with basal-bolus analogs compared with basal-bolus nonanalog insulin. When compared with regular sliding-scale insulin (SSI), fixed-dose insulin glargine with or without insulin glulisine was found to reduce the blood glucose concentration in patients with type 2 diabetes and reduce postoperative complications in surgical patients with diabetes. The quality of evidence was primarily very low or low for most outcomes.

Conclusion: A systematic literature review revealed a very low or low quality of evidence, suggesting that, compared with nonanalog regimens, rapid-acting insulin analogs reduce the duration of hospital stay and mortality rates and that basal- bolus analog regimens may reduce the duration of hospital stay and postoperative complications. There is also a low quality of evidence to suggest that a fixed-dose analog regimen of insulin glargine with or without insulin glulisine is more effective than regular SSI for reducing blood glucose concentrations and postoperative complications.
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http://dx.doi.org/10.2146/ajhp140161DOI Listing
April 2015
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