Publications by authors named "Karen A Robinson"

154 Publications

The Effect of Lutein/Zeaxanthin Intake on Human Macular Pigment Optical Density: A Systematic Review and Meta-Analysis.

Adv Nutr 2021 Jun 22. Epub 2021 Jun 22.

Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

Lutein, zeaxanthin, and meso-zeaxanthin are the only carotenoids found in the human macula and may have a role in visual function. These carotenoids are reported to protect the retina, and thus vision, as antioxidants and by acting as a blue light filter. Our objective was to determine a minimum concentration of lutein/zeaxanthin intake that is associated with a statistically significant and/or clinically important change in macular pigment optical density (MPOD) among adults with healthy eyes. We searched Ovid MEDLINE, CENTRAL, and the Commonwealth of Agriculture Bureau for English-language studies through to July 2020. Two reviewers screened results to identify studies that evaluated supplements or dietary sources of lutein/zeaxanthin on MPOD among adults with healthy eyes. One reviewer extracted data and assessed strength of evidence, which was confirmed by a second reviewer. Two independent reviewers assessed the risk of bias. Meta-analyses were stratified by total lutein/zeaxanthin dose. We included 46 studies (N = 3189 participants; mean age = 43 y; 42% male). There was no statistically significant change in MPOD among studies evaluating <5 mg/d of total lutein/zeaxanthin intake which primarily assessed dietary interventions for 3-6 mo (pooled mean difference, 0.02; 95% CI: -0.01 to 0.05). The pooled mean increase in MPOD was 0.04 units (95% CI: 0.02 to 0.07) among studies evaluating 5 to <20 mg/d of lutein/zeaxanthin and was 0.11 units (95% CI: 0.06 to 0.16) among studies evaluating ≥20 mg/d of lutein/zeaxanthin for 3-12 mo. MPOD increased with lutein/zeaxanthin intake, particularly at higher doses, among adults with healthy eyes. The effects of lutein/zeaxanthin intake at doses <5 mg/d or from dietary sources is less clear. Increased lutein/zeaxanthin intake can help with maintaining ocular health. Future research is needed to determine the minimum dose and duration of lutein/zeaxanthin intake that is associated with a clinically important change in MPOD or visual function.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/advances/nmab071DOI Listing
June 2021

The Effect of Lutein/Zeaxanthin Intake on Human Macular Pigment Optical Density: A Systematic Review and Meta-Analysis.

Adv Nutr 2021 Jun 22. Epub 2021 Jun 22.

Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

Lutein, zeaxanthin, and meso-zeaxanthin are the only carotenoids found in the human macula and may have a role in visual function. These carotenoids are reported to protect the retina, and thus vision, as antioxidants and by acting as a blue light filter. Our objective was to determine a minimum concentration of lutein/zeaxanthin intake that is associated with a statistically significant and/or clinically important change in macular pigment optical density (MPOD) among adults with healthy eyes. We searched Ovid MEDLINE, CENTRAL, and the Commonwealth of Agriculture Bureau for English-language studies through to July 2020. Two reviewers screened results to identify studies that evaluated supplements or dietary sources of lutein/zeaxanthin on MPOD among adults with healthy eyes. One reviewer extracted data and assessed strength of evidence, which was confirmed by a second reviewer. Two independent reviewers assessed the risk of bias. Meta-analyses were stratified by total lutein/zeaxanthin dose. We included 46 studies (N = 3189 participants; mean age = 43 y; 42% male). There was no statistically significant change in MPOD among studies evaluating <5 mg/d of total lutein/zeaxanthin intake which primarily assessed dietary interventions for 3-6 mo (pooled mean difference, 0.02; 95% CI: -0.01 to 0.05). The pooled mean increase in MPOD was 0.04 units (95% CI: 0.02 to 0.07) among studies evaluating 5 to <20 mg/d of lutein/zeaxanthin and was 0.11 units (95% CI: 0.06 to 0.16) among studies evaluating ≥20 mg/d of lutein/zeaxanthin for 3-12 mo. MPOD increased with lutein/zeaxanthin intake, particularly at higher doses, among adults with healthy eyes. The effects of lutein/zeaxanthin intake at doses <5 mg/d or from dietary sources is less clear. Increased lutein/zeaxanthin intake can help with maintaining ocular health. Future research is needed to determine the minimum dose and duration of lutein/zeaxanthin intake that is associated with a clinically important change in MPOD or visual function.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/advances/nmab071DOI Listing
June 2021

Advance Care Planning Shared Decision-Making Tools for Non-Cancer Chronic Serious Illness: A Mixed Method Systematic Review.

Am J Hosp Palliat Care 2021 Feb 15:1049909121995416. Epub 2021 Feb 15.

Johns Hopkins University, School of Nursing, Baltimore, MD, USA.

Context: Shared decision-making tools can facilitate advance care planning and goals of care conversations in non-cancer serious illness. More information on integrating these tools in ambulatory care could better support clinicians and patients/caregivers in these conversations.

Objectives: We evaluated effectiveness and implementation of integrating palliative care shared decision-making tools into ambulatory care for U.S. adults with serious, life-threatening illness and their caregivers.

Data Sources: We searched PubMed, CINAHL, and the Cochrane Central Register of Controlled Trials (2000 - May 2020) for quantitative controlled, qualitative, and mixed-methods studies.

Review Methods: Two reviewers screened articles, abstracted data, and independently assessed risk of bias or study quality. For quantitative trials, we graded strength of evidence for key outcomes: patient/caregiver satisfaction, depression or anxiety, concordance between patient preferences for care and care received, and healthcare utilization, including advance directive documentation.

Results: We included 6 quantitative effectiveness randomized, controlled trials and 5 qualitative implementation studies across primary care and specialty populations. Shared decision-making tools all addressed goals-of-care communication or advance care planning. Palliative care shared decision-making tools may be effective for improving patient satisfaction with communication and advance directive documentation. We were unable to draw conclusions about concordance between preferences and care received. Patients and caregivers preferred advance care planning discussions grounded in patient and caregiver experiences with individualized timing.

Conclusions: For non-cancer serious illness, advance care planning shared decision-making tools may improve several outcomes. Future trials should evaluate concordance with care received and other health care utilization.

Key Message: This mixed-methods review concludes that when integrating palliative care into ambulatory care for serious illness and conditions other than cancer, advance care planning shared decision-making tools may improve patient satisfaction and advance directive documentation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/1049909121995416DOI Listing
February 2021

Effect of redundant clinical trials from mainland China evaluating statins in patients with coronary artery disease: cross sectional study.

BMJ 2021 02 2;372:n48. Epub 2021 Feb 2.

Department of Medicine, School of Medicine, Johns Hopkins University, 1830 East Monument Street, Suite 8068, Baltimore, MD 21287, USA

Objective: To identify redundant clinical trials evaluating statin treatment in patients with coronary artery disease from mainland China, and to estimate the number of extra major adverse cardiac events (MACEs) experienced by participants not treated with statins in those trials.

Design: Cross sectional study.

Setting: 2577 randomized clinical trials comparing statin treatment with placebo or no treatment in patients with coronary artery disease from mainland China, searched from bibliographic databases to December 2019.

Participants: 250 810 patients with any type of coronary artery disease who were enrolled in the 2577 randomized clinical trials.

Main Outcome Measures: Redundant clinical trials were defined as randomized clinical trials that initiated or continued recruiting after 2008 (ie, one year after statin treatment was strongly recommended by clinical practice guidelines). The primary outcome is the number of extra MACEs that were attributable to the deprivation of statins among patients in the control groups of redundant clinical trials-that is, the number of extra MACEs that could have been prevented if patients were given statins. Cumulative meta-analyses were also conducted to establish the time points when statins were shown to have a statistically significant effect on coronary artery disease.

Results: 2045 redundant clinical trials were identified published between 2008 and 2019, comprising 101 486 patients in the control groups not treated with statins for 24 638 person years. 3470 (95% confidence interval 3230 to 3619) extra MACEs were reported, including 559 (95% confidence interval 506 to 612) deaths, 973 (95% confidence interval 897 to 1052) patients with new or recurrent myocardial infarction, 161 (132 to 190) patients with stroke, 83 (58 to 105) patients requiring revascularization, 398 (352 to 448) patients with heart failure, 1197 (1110 to 1282) patients with recurrent or deteriorated angina pectoris, and 99 (95% confidence interval 69 to 129) unspecified MACEs.

Conclusions: Of more than 2000 redundant clinical trials on statins in patients with coronary artery disease identified from mainland China, an extra 3000 MACEs, including nearly 600 deaths, were experienced by participants not treated with statins in these trials. The scale of redundancy necessitates urgent reform to protect patients.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmj.n48DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7851709PMC
February 2021

Association between switching of primary outcomes and reported trial findings among randomized drug trials from China.

J Clin Epidemiol 2021 Apr 9;132:10-17. Epub 2020 Dec 9.

Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, MD, USA. Electronic address:

Background And Objective: To evaluate the association between the nature of findings and the switching of registered primary outcomes among randomized controlled trials (RCTs) from mainland China.

Methods: This is a retrospective cohort study. We retrieved RCTs from trial registries and identified the corresponding journal articles from bibliographic databases until August 2019. Trial registries and journal articles were compared to evaluate whether registered primary outcomes with negative findings were more likely to be switched to secondary outcomes in the subsequent journal articles than those with positive findings.

Results: Switching of registered primary outcomes occurred in 131 (45%) of 294 RCTs. A total of 450 registered primary outcomes were matched to 522 (37%) primary outcomes and 871 (63%) secondary outcomes in the journal articles. Among RCTs registered before they started, the odds of switching primary outcomes with negative findings were 2.64 (95% CI: 1.16-6.02) times the odds of switching those with positive findings. Among RCTs registered when they were ongoing, the odds of switching primary outcomes with negative findings were 8.84 (95% CI: 3.62-25.93) times the odds of switching those with positive findings.

Conclusion: The nature of findings may play a role in how likely a prespecified primary outcome is switched subsequently.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jclinepi.2020.11.023DOI Listing
April 2021

Assessment of Duplicate Publication of Chinese-Sponsored Randomized Clinical Trials.

JAMA Netw Open 2020 12 1;3(12):e2027104. Epub 2020 Dec 1.

Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, Maryland.

Importance: Duplicate publications of randomized clinical trials are prevalent in the health-related literature. To date, few studies have assessed the interaction between duplicate publication and the language of the original publication.

Objective: To assess the existence of duplicate publication and the extent to which duplicate publication is associated with the language of the original publication.

Design, Setting, And Participants: In this retrospective cohort study, eligible randomized clinical trials were retrieved from trial registries, and bibliographic databases were searched to determine their publication status. Eligible randomized clinical trials were for drug interventions from January 1, 2008, to December 31, 2014. The search and analysis were conducted from March 1 to August 31, 2019. The trial registries were either primary registries recognized by the World Health Organization or the Drug Clinical Trial Registry Platform sponsored by the China Food and Drug Administration.

Exposures: Individual randomized clinical trials with positive vs negative results.

Main Outcomes And Measures: Journal articles were classified as main articles (determined by largest sample size and longest follow-up among all journal articles derived from that randomized clinical trial) and duplicates. The duplicates were classified into 4 types: (1) unreferenced subgroup analysis (article did not disclose itself as a subgroup analysis or reference its main article); (2) unreferenced republication (article did not disclose itself as a replicate of the main article or reference it); (3) unreferenced interim analysis (article did not disclose itself as an interim analysis or reference its main article); and (4) partial duplicate (article did not disclose its sharing a subset of participants with other articles or reference them).

Results: Among 470 randomized clinical trials published by August 2019 as journal articles, 55 (11.7%) had 75 duplicates, of which 53 (70.7%) were cross-language duplicates. Of the 75 duplicates, 33 (44.0%) were unreferenced republications, 25 (33.3%) unreferenced subgroup analyses, 15 (20.0%) unreferenced interim analyses, and 2 (2.7%) partial duplicates. When the main article of a randomized clinical trial was published in Chinese, those with positive findings were 2.48 (95% CI, 1.08-5.71) times more likely to have subsequent duplicate publication than those with negative findings.

Conclusions And Relevance: In this study, most duplicates were cross-language duplicates and the most common type was unreferenced republication of the main article. Duplicate publication bias exists when the main articles of randomized clinical trials were published in Chinese, potentially misleading readers and compromising journals and evidence synthesis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1001/jamanetworkopen.2020.27104DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7716193PMC
December 2020

Evidence-Based Research Series-Paper 2 : Using an Evidence-Based Research approach before a new study is conducted to ensure value.

J Clin Epidemiol 2021 Jan 26;129:158-166. Epub 2020 Sep 26.

Johns Hopkins University School of Medicine, Baltimore, MD.

Background And Objectives: There is considerable actual and potential waste in research. The aim of this article is to describe how using an evidence-based research approach before conducting a study helps to ensure that the new study truly adds value.

Study Design And Setting: Evidence-based research is the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner. In this second article of the evidence-based research series, we describe how to apply an evidence-based research approach before starting a new study.

Results: Before a new study is performed, researchers need to provide a solid justification for it using the available scientific knowledge as well as the perspectives of end users. The key method for both is to conduct a systematic review of earlier relevant studies.

Conclusion: Describing the ideal process illuminates the challenges and opportunities offered through the suggested evidence-based research approach. A systematic and transparent approach is needed to provide justification for and to optimally design a relevant and necessary new study.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jclinepi.2020.07.019DOI Listing
January 2021

Evidence-Based Research Series-Paper 1: What Evidence-Based Research is and why is it important?

J Clin Epidemiol 2021 Jan 23;129:151-157. Epub 2020 Sep 23.

Section for Evidence-Based Practice, Western Norway University of Applied Sciences, Inndalsveien 28, Bergen, P.O.Box 7030 N-5020 Bergen, Norway. Electronic address:

Objectives: There is considerable actual and potential waste in research. Evidence-based research ensures worthwhile and valuable research. The aim of this series, which this article introduces, is to describe the evidence-based research approach.

Study Design And Setting: In this first article of a three-article series, we introduce the evidence-based research approach. Evidence-based research is the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner.

Results: We describe evidence-based research and provide an overview of the approach of systematically and transparently using previous research before starting a new study to justify and design the new study (article #2 in series) and-on study completion-place its results in the context with what is already known (article #3 in series).

Conclusion: This series introduces evidence-based research as an approach to minimize unnecessary and irrelevant clinical health research that is unscientific, wasteful, and unethical.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jclinepi.2020.07.020DOI Listing
January 2021

Evidence-Based Research Series-Paper 3: Using an Evidence-Based Research approach to place your results into context after the study is performed to ensure usefulness of the conclusion.

J Clin Epidemiol 2021 Jan 23;129:167-171. Epub 2020 Sep 23.

Johns Hopkins Evidence-based Practice Center, Division of General Internal Medicine, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.

Background And Objective: There is considerable actual and potential waste in research. Using evidence-based research (EBR) can ensure the value of a new study. The aim of this article, the third in a series, is to describe an EBR approach to putting research results into context.

Study Design And Setting: EBR is the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner. In this third and final article of a series, we describe how to use the context of existing evidence to reach and present a trustworthy and useful conclusion when reporting results from a new clinical study.

Results: We describe a method, the EBR approach, that by using a systematic and transparent consideration of earlier similar studies when interpreting and presenting results from a new original study will ensure usefulness of the conclusion.

Conclusion: Using an EBR approach will improve the usefulness of a clinical study by providing the context to draw more valid conclusions and explicit information about new research needs.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jclinepi.2020.07.021DOI Listing
January 2021

Assessment of Language and Indexing Biases Among Chinese-Sponsored Randomized Clinical Trials.

JAMA Netw Open 2020 05 1;3(5):e205894. Epub 2020 May 1.

Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, Maryland.

Importance: Language and indexing biases may exist among Chinese-sponsored randomized clinical trials (CS-RCTs). Such biases may threaten the validity of systematic reviews.

Objective: To evaluate the existence of language and indexing biases among CS-RCTs on drug interventions.

Design, Setting, And Participants: In this retrospective cohort study, eligible CS-RCTs were retrieved from trial registries, and bibliographic databases were searched to determine their publication status. Eligible CS-RCTs were for drug interventions conducted from January 1, 2008, to December 31, 2014. The search and analysis were conducted from March 1 to August 31, 2019. Primary trial registries were recognized by the World Health Organization and the Drug Clinical Trial Registry Platform sponsored by the China Food and Drug Administration.

Exposures: Individual CS-RCTs with positive vs negative results (positive vs negative CS-RCTs).

Main Outcomes And Measures: For assessing language bias, the main outcome was the language of the journal in which CS-RCTs were published (English vs Chinese). For indexing bias, the main outcome was the language of the bibliographic database where the CS-RCTs were indexed (English vs Chinese).

Results: The search identified 891 eligible CS-RCTs. Four hundred seventy CS-RCTs were published by August 31, 2019, of which 368 (78.3%) were published in English. Among CS-RCTs registered in the Chinese Clinical Trial Registry (ChiCTR), positive CS-RCTs were 3.92 (95% CI, 2.20-7.00) times more likely to be published in English than negative CS-RCTs; among CS-RCTs in English-language registries, positive CS-RCTs were 3.22 (95% CI, 1.34-7.78) times more likely to be published in English than negative CS-RCTs. These findings suggest the existence of language bias. Among CS-RCTs registered in ChiCTR, positive CS-RCTs were 2.89 (95% CI, 1.55-5.40) times more likely to be indexed in English bibliographic databases than negative CS-RCTs; among CS-RCTs in English-language registries, positive CS-RCTs were 2.19 (95% CI, 0.82-5.82) times more likely to be indexed in English bibliographic databases than negative CS-RCTs. These findings support the existence of indexing bias.

Conclusions And Relevance: This study suggests the existence of language and indexing biases among registered CS-RCTs on drug interventions. These biases may distort evidence synthesis toward more positive results of drug interventions.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1001/jamanetworkopen.2020.5894DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7256669PMC
May 2020

Antipsychotics for Preventing Delirium in Hospitalized Adults.

Ann Intern Med 2020 03;172(5):366

Johns Hopkins University School of Medicine, Baltimore, Maryland (E.S.O., D.M.N., K.A.R., K.J.N.).

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.7326/L19-0755DOI Listing
March 2020

Do Neuroleptics Still Have a Role in Patients With Delirium?

Ann Intern Med 2020 02;172(4):295-296

Johns Hopkins University School of Medicine, Baltimore, Maryland (R.N., E.S.O., K.A.R., D.M.N.).

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.7326/L19-0703DOI Listing
February 2020

Antipsychotics for Treating Delirium in Hospitalized Adults: A Systematic Review.

Ann Intern Med 2019 10 3;171(7):485-495. Epub 2019 Sep 3.

Johns Hopkins University School of Medicine, Baltimore, Maryland (R.N., K.J.N., E.S.O., K.A.R., D.M.N.).

Background: Delirium is common in hospitalized patients and is associated with worse outcomes. Antipsychotics are commonly used; however, the associated benefits and harms are unclear.

Purpose: To conduct a systematic review evaluating the benefits and harms of antipsychotics to treat delirium in adults.

Data Sources: PubMed, Embase, CENTRAL, CINAHL, and PsycINFO from inception to July 2019 without language restrictions.

Study Selection: Randomized controlled trials (RCTs) of antipsychotic versus placebo or another antipsychotic, and prospective observational studies reporting harms.

Data Extraction: One reviewer extracted data and assessed strength of evidence (SOE) for critical outcomes, with confirmation by another reviewer. Risk of bias was assessed independently by 2 reviewers.

Data Synthesis: Across 16 RCTs and 10 observational studies of hospitalized adults, there was no difference in sedation status (low and moderate SOE), delirium duration, hospital length of stay (moderate SOE), or mortality between haloperidol and second-generation antipsychotics versus placebo. There was no difference in delirium severity (moderate SOE) and cognitive functioning (low SOE) for haloperidol versus second-generation antipsychotics, with insufficient or no evidence for antipsychotics versus placebo. For direct comparisons of different second-generation antipsychotics, there was no difference in mortality and insufficient or no evidence for multiple other outcomes. There was little evidence demonstrating neurologic harms associated with short-term use of antipsychotics for treating delirium in adult inpatients, but potentially harmful cardiac effects tended to occur more frequently.

Limitations: Heterogeneity was present in terms of dose and administration route of antipsychotics, outcomes, and measurement instruments. There was insufficient or no evidence regarding multiple clinically important outcomes.

Conclusion: Current evidence does not support routine use of haloperidol or second-generation antipsychotics to treat delirium in adult inpatients.

Primary Funding Source: Agency for Healthcare Research and Quality. (PROSPERO: CRD42018109552).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.7326/M19-1860DOI Listing
October 2019

Antipsychotics for Preventing Delirium in Hospitalized Adults: A Systematic Review.

Ann Intern Med 2019 10 3;171(7):474-484. Epub 2019 Sep 3.

Johns Hopkins University School of Medicine, Baltimore, Maryland (E.S.O., D.M.N., R.N., K.A.R., K.J.N.).

Background: Delirium is an acute disorder marked by impairments in attention and cognition, caused by an underlying medical problem. Antipsychotics are used to prevent delirium, but their benefits and harms are unclear.

Purpose: To conduct a systematic review evaluating the benefits and harms of antipsychotics for prevention of delirium in adults.

Data Sources: PubMed, Embase, CENTRAL, CINAHL, and PsycINFO from inception through July 2019, without restrictions based on study setting, language of publication, or length of follow-up.

Study Selection: Randomized, controlled trials (RCTs) that compared an antipsychotic with placebo or another antipsychotic, and prospective observational studies with a comparison group.

Data Extraction: One reviewer extracted data and graded the strength of the evidence, and a second reviewer confirmed the data. Two reviewers independently assessed the risk of bias.

Data Synthesis: A total of 14 RCTs were included. There were no differences in delirium incidence or duration, hospital length of stay (high strength of evidence [SOE]), and mortality between haloperidol and placebo used for delirium prevention. Little to no evidence was found to determine the effect of haloperidol on cognitive function, delirium severity (insufficient SOE), inappropriate continuation, and sedation (insufficient SOE). There is limited evidence that second-generation antipsychotics may lower delirium incidence in the postoperative setting. There is little evidence that short-term use of antipsychotics was associated with neurologic harms. In some of the trials, potentially harmful cardiac effects occurred more frequently with antipsychotic use.

Limitations: There was significant heterogeneity in antipsychotic dosing, route of antipsychotic administration, assessment of outcomes, and adverse events. There were insufficient or no data available to draw conclusions for many of the outcomes.

Conclusion: Current evidence does not support routine use of haloperidol or second-generation antipsychotics for prevention of delirium. There is limited evidence that second-generation antipsychotics may lower the incidence of delirium in postoperative patients, but more research is needed. Future trials should use standardized outcome measures.

Primary Funding Source: Agency for Healthcare Research and Quality. (PROSPERO: CRD42018109552).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.7326/M19-1859DOI Listing
October 2019

Airway clearance techniques for cystic fibrosis: an overview of Cochrane systematic reviews.

Cochrane Database Syst Rev 2019 01 24;1:CD011231. Epub 2019 Jan 24.

Evidence-based Practice Center, Johns Hopkins University, Hampton House, 6th Floor, 624 North Broadway, Baltimore, MD, USA, 21205-1901.

Background: Cystic fibrosis is a life-limiting genetic condition in which thick mucus builds up in the lungs, leading to infections, inflammation, and eventually, deterioration in lung function. To clear their lungs of mucus, people with cystic fibrosis perform airway clearance techniques daily. There are various airway clearance techniques, which differ in terms of the need for assistance or equipment, and cost.

Objectives: To summarise the evidence from Cochrane Reviews on the effectiveness and safety of various airway clearance techniques in people with cystic fibrosis.

Methods: For this overview, we included Cochrane Reviews of randomised or quasi-randomised controlled trials (including cross-over trials) that evaluated an airway clearance technique (conventional chest physiotherapy, positive expiratory pressure (PEP) therapy, high-pressure PEP therapy, active cycle of breathing techniques, autogenic drainage, airway oscillating devices, external high frequency chest compression devices and exercise) in people with cystic fibrosis.We searched the Cochrane Database of Systematic Reviews on 29 November 2018.Two review authors independently evaluated reviews for eligibility. One review author extracted data from included reviews and a second author checked the data for accuracy. Two review authors independently graded the quality of reviews using the ROBIS tool. We used the GRADE approach for assessing the overall strength of the evidence for each primary outcome (forced expiratory volume in one second (FEV), individual preference and quality of life).

Main Results: We included six Cochrane Reviews, one of which compared any type of chest physiotherapy with no chest physiotherapy or coughing alone and the remaining five reviews included head-to-head comparisons of different airway clearance techniques. All the reviews were considered to have a low risk of bias. However, the individual trials included in the reviews often did not report sufficient information to adequately assess risk of bias. Many trials did not sufficiently report on outcome measures and had a high risk of reporting bias.We are unable to draw definitive conclusions for comparisons of airway clearance techniques in terms of FEV, except for reporting no difference between PEP therapy and oscillating devices after six months of treatment, mean difference -1.43% predicted (95% confidence interval -5.72 to 2.87); the quality of the body of evidence was graded as moderate. The quality of the body of evidence comparing different airway clearance techniques for other outcomes was either low or very low.

Authors' Conclusions: There is little evidence to support the use of one airway clearance technique over another. People with cystic fibrosis should choose the airway clearance technique that best meets their needs, after considering comfort, convenience, flexibility, practicality, cost, or some other factor. More long-term, high-quality randomised controlled trials comparing airway clearance techniques among people with cystic fibrosis are needed.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/14651858.CD011231.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6353051PMC
January 2019

Polybrominated diphenyl ether (PBDE) neurotoxicity: a systematic review and meta-analysis of animal evidence.

J Toxicol Environ Health B Crit Rev 2018 23;21(4):269-289. Epub 2018 Oct 23.

l Biological Sciences Division , Pacific Northwest National Laboratory , Richland , WA , USA.

A recent systematic review (SR) and meta-analysis of human studies found an association between prenatal serum polybrominated diphenyl ethers (PBDE) concentrations and a decrease in the IQ of children. A SR of experimental developmental animal PBDE-mediated neurotoxicity studies was performed in the present study. Outcomes assessed included measures related to learning, memory, and attention, which parallel the intelligence-related outcomes evaluated in the human studies SR. PubMed, Embase, and Toxline were searched for relevant experimental non-human mammalian studies. Evaluation of risk of bias (RoB) and overall body of evidence followed guidance developed by the National Toxicology Program. Animal studies using varying designs and outcomes were available for BDEs 47, 99, 153, 203, 206, and 209 and the technical mixture DE-71. Study reporting of methods and results was often incomplete leading to concerns regarding RoB. A meta-analysis of 6 Morris water maze studies showed evidence of a significant increase in last trial latency (effect size of 25.8 [CI, 20.3 to 31.2]) in PBDE-exposed animals with low heterogeneity. For most endpoints, there were unexplained inconsistencies across studies and no consistent evidence of a dose-response relationship. There is a "moderate" level of evidence that exposure to BDEs 47, 99, and 209 affects learning. For other PBDEs and other endpoints, the level of evidence was "low" or "very low". The meta-analysis led to stronger conclusions than that based upon a qualitative review of the evidence. The SR also identified RoB concerns that might be remedied by better study reporting.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1080/10937404.2018.1514829DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6786272PMC
August 2019

Gaps in the evidence for treatment decisions in cystic fibrosis: a systematic review.

Thorax 2019 03 9;74(3):229-236. Epub 2018 Oct 9.

Evidence Based Child Health Group, Division of Child Health, Obstetrics and Gynaecology, University of Nottingham, Nottingham, UK.

Introduction: Cystic fibrosis (CF) is a multisystem disorder. Treatment is complex and evidence for treatment decisions may be absent. Characterising gaps in the research evidence will highlight treatment uncertainties and help prioritise research questions. We systematically identified the evidence gaps for treatment decisions in CF.

Methods: We searched for systematic reviews and guidelines on treatment interventions in CF. Two researchers identified eligible reviews with arbitration from a third. Using a structured framework, we extracted and characterised evidence gaps.

Results: There were 73 reviews and 21 guidelines that met our inclusion criteria. From these, we identified 148 evidence gaps across a range of treatment areas. We found 111 evidence gaps through systematic reviews and a further 37 from guidelines. The reason for an evidence gap could only be reliably characterised for systematic reviews. In most cases, there was more than one explanation-most commonly few or no trials (97/111 evidence gaps). Other important factors leading to evidence gaps were small sample size (49/111), inadequate duration of follow-up (38/111) or intervention (37/111) and factors relating to outcomes (35/111). Evidence gaps from both systematic reviews and guidelines fell into the following categories: Respiratory (91); Gastrointestinal (20); PhysiotherapyandExercise (16); Musculoskeletal (6); Endocrine (4); Basic defect of CF (8); Psychosocial (2); Ears, Nose and Throat (1).

Conclusions: We have compiled an up-to-date list of treatment uncertainties in CF and the reasons for these uncertainties. These can be used as a resource to aid researchers and funders when planning future trials.

Prospero Registration Number: Pre-results; CRD42015030111.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/thoraxjnl-2017-210858DOI Listing
March 2019

Systematic reviews and meta-analyses of human and animal evidence of prenatal diethylhexyl phthalate exposure and changes in male anogenital distance.

J Toxicol Environ Health B Crit Rev 2018 10;21(4):207-226. Epub 2018 Sep 10.

l Biological Sciences Division , Pacific Northwest National Laboratory , Richland , WA , USA.

Male reproductive alterations found in animals and humans following in utero phthalate exposure include decreased anogenital distance (AGD) and other reproductive-tract malformations. The aim of this investigation was to conduct systematic reviews of human and animal evidence of the effect of in utero exposure to diethylhexyl phthalate (DEHP) on anogenital distance (AGD) in males. PubMed, Embase, and Toxline were searched for relevant human and experimental animal studies on August 15, 2016. Search results were screened for relevance, and studies that met the inclusion criteria were evaluated for quality and data extracted for analysis. Confidence in the human and animal bodies of evidence was assessed and hazard conclusions reached by integrating evidence streams. The search yielded 6 relevant human studies and 19 animal studies. Meta-analysis of 5 human observational prospective cohort studies showed that increased maternal urinary concentrations of DEHP metabolites were associated with decreased AGD in boys (-4.07 [CI, -6.49 to -1.66] % decrease per log rise in DEHP metabolites). Meta-analysis and meta-regression of the 19 experimental animal studies found reduced AGD with DEHP treatment, with a dose-response gradient, and with heterogeneity explained by species and strain. There is a moderate level of evidence from human investigations and a high level of data from animal studies that in utero exposure to DEHP decreases AGD. Based upon the available human and animal evidence, and consideration of mechanistic data, DEHP is presumed to be a reproductive hazard to humans on the basis of effects on AGD.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1080/10937404.2018.1505354DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6786271PMC
August 2019

Consensus Recommendations for RBC Transfusion Practice in Critically Ill Children From the Pediatric Critical Care Transfusion and Anemia Expertise Initiative.

Pediatr Crit Care Med 2018 09;19(9):884-898

Department of Pediatrics and Pathology, George Washington University, Washington, DC.

Objectives: To date, there are no published guidelines to direct RBC transfusion decision-making specifically for critically ill children. We present the recommendations from the Pediatric Critical Care Transfusion and Anemia Expertise Initiative.

Design: Consensus conference series of multidisciplinary, international experts in RBC transfusion management of critically ill children.

Setting: Not applicable.

Intervention: None.

Subjects: Children with, or children at risk for, critical illness who receive or are at risk for receiving a RBC transfusion.

Methods: A panel of 38 content and four methodology experts met over the course of 2 years to develop evidence-based, and when evidence lacking, expert consensus-based recommendations regarding decision-making for RBC transfusion management and research priorities for transfusion in critically ill children. The experts focused on nine specific populations of critically ill children: general, respiratory failure, nonhemorrhagic shock, nonlife-threatening bleeding or hemorrhagic shock, acute brain injury, acquired/congenital heart disease, sickle cell/oncology/transplant, extracorporeal membrane oxygenation/ventricular assist/ renal replacement support, and alternative processing. Data to formulate evidence-based and expert consensus recommendations were selected based on searches of PubMed, EMBASE, and Cochrane Library from 1980 to May 2017. Agreement was obtained using the Research and Development/UCLA Appropriateness Method. Results were summarized using the Grading of Recommendations Assessment, Development, and Evaluation method.

Measurements And Results: The Transfusion and Anemia Expertise Initiative consensus conference developed and reached consensus on a total of 102 recommendations (57 clinical [20 evidence based, 37 expert consensus], 45 research recommendations). All final recommendations met agreement, defined a priori as greater than 80%. A decision tree to aid clinicians was created based on the clinical recommendations.

Conclusions: The Transfusion and Anemia Expertise Initiative recommendations provide important clinical guidance and applicable tools to avoid unnecessary RBC transfusions. Research recommendations identify areas of focus for future investigation to improve outcomes and safety for RBC transfusion.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/PCC.0000000000001613DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6126913PMC
September 2018

The Pediatric Critical Care Transfusion and Anemia Expertise Initiative Consensus Conference Methodology.

Pediatr Crit Care Med 2018 09;19(9S Suppl 1):S93-S97

Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.

Objectives: This article describes the methodology used for Pediatric Critical Care Transfusion and Anemia Expertise Initiative Consensus Conference.

Design: Consensus conference of international experts in pediatric critical care and transfusion medicine, following standards set by the Institute of Medicine, using the Research and Development/UCLA Appropriateness Method, modeled after the Pediatric Acute Lung Injury Consensus Conference. Topics related to RBC transfusion in children with or at risk for critical illness were divided into nine subgroups with a systematic review of the literature.

Methods: The panel of 38 content and four methodology experts met three times over the course of 2 years and collaborated to develop evidence-based and, when evidence was lacking, expert-based clinical recommendations as well as research priorities for RBC transfusions in critically ill children or those at risk for critical illness. Electronic searches were conducted using PubMed, Embase, and Cochrane Library databases from 1980 to May 2017. Agreement was obtained using the Research and Development/UCLA Appropriateness Method. We used a standardized data extraction form to construct evidence tables and graded the evidence using the Grading of Recommendations Assessment, Development, and Evaluation system.

Main Results: The consensus conference resulted in 102 recommendation statements, of which 57 were clinical (20 evidence based and 37 based on expert consensus) and 45 detailed recommendations for future research. Dissemination was done via decision tree, a primary publication listing all statements, and separate publications for each subtopic that include supporting arguments for each recommendation.

Conclusions: A consensus conference of experts from around the world developed recommendations for RBC transfusions in critically ill children or children at risk for critical illness, the identification of current research gaps, and future research priorities.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/PCC.0000000000001593DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6126354PMC
September 2018

Non-pharmacologic treatments for symptoms of diabetic peripheral neuropathy: a systematic review.

Curr Med Res Opin 2019 01 17;35(1):15-25. Epub 2018 Aug 17.

Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

To systematically assess benefits and harm of non-pharmacologic interventions for diabetic peripheral neuropathy (DPN) symptoms. MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were searched from 1966 to May 24, 2016 for randomized controlled trials. Two reviewers evaluated studies for eligibility, serially abstracted data, evaluated risk of bias, and graded strength of evidence (SOE) for critical outcomes (pain and quality-of-life). Twenty-three trials were included. For pain, alpha-lipoic acid was more effective than placebo (moderate SOE) and frequency-modulated electromagnetic stimulation was more effective than sham (low SOE) in the short-term but not the long-term. Electrical stimulation (including transcutaneous) was not effective for pain (low SOE). Spinal cord stimulation was more effective than usual care for pain (low SOE), but had serious complications, and studies had no sham arm. Evidence for cognitive behavioral therapy and acupuncture was insufficient; no exercise or physical therapy trials met inclusion criteria. No interventions reported sufficient evidence on quality-of-life. Most studies were short-term with unclear risk of bias. Alpha-lipoic acid and spinal cord stimulation were effective for pain; studies were short-term with quality deficits. Spinal cord stimulation had serious adverse events. Further research should address long-term outcomes and other non-pharmacologic treatments.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1080/03007995.2018.1497958DOI Listing
January 2019

Non-pharmacologic treatments for symptoms of diabetic peripheral neuropathy: a systematic review.

Curr Med Res Opin 2019 01 17;35(1):15-25. Epub 2018 Aug 17.

Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

To systematically assess benefits and harm of non-pharmacologic interventions for diabetic peripheral neuropathy (DPN) symptoms. MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were searched from 1966 to May 24, 2016 for randomized controlled trials. Two reviewers evaluated studies for eligibility, serially abstracted data, evaluated risk of bias, and graded strength of evidence (SOE) for critical outcomes (pain and quality-of-life). Twenty-three trials were included. For pain, alpha-lipoic acid was more effective than placebo (moderate SOE) and frequency-modulated electromagnetic stimulation was more effective than sham (low SOE) in the short-term but not the long-term. Electrical stimulation (including transcutaneous) was not effective for pain (low SOE). Spinal cord stimulation was more effective than usual care for pain (low SOE), but had serious complications, and studies had no sham arm. Evidence for cognitive behavioral therapy and acupuncture was insufficient; no exercise or physical therapy trials met inclusion criteria. No interventions reported sufficient evidence on quality-of-life. Most studies were short-term with unclear risk of bias. Alpha-lipoic acid and spinal cord stimulation were effective for pain; studies were short-term with quality deficits. Spinal cord stimulation had serious adverse events. Further research should address long-term outcomes and other non-pharmacologic treatments.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1080/03007995.2018.1497958DOI Listing
January 2019
-->