Sample records for clinical study reported
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Hodkinson, Alex; Gamble, Carrol; Smith, Catrin Tudur
2016-04-22
The quality of harms reporting in journal publications is often poor, which can impede the risk-benefit interpretation of a clinical trial. Clinical study reports can provide more reliable, complete, and informative data on harms compared to the corresponding journal publication. This case study compares the quality and quantity of harms data reported in journal publications and clinical study reports of orlistat trials. Publications related to clinical trials of orlistat were identified through comprehensive literature searches. A request was made to Roche (Genentech; South San Francisco, CA, USA) for clinical study reports related to the orlistat trials identified in our search. We compared adverse events, serious adverse events, and the reporting of 15 harms criteria in both document types and compared meta-analytic results using data from the clinical study reports against the journal publications. Five journal publications with matching clinical study reports were available for five independent clinical trials. Journal publications did not always report the complete list of identified adverse events and serious adverse events. We found some differences in the magnitude of the pooled risk difference between both document types with a statistically significant risk difference for three adverse events and two serious adverse events using data reported in the clinical study reports; these events were of mild intensity and unrelated to the orlistat. The CONSORT harms reporting criteria were often satisfied in the methods section of the clinical study reports (70-90 % of the methods section criteria satisfied in the clinical study reports compared to 10-50 % in the journal publications), but both document types satisfied 80-100 % of the results section criteria, albeit with greater detail being provided in the clinical study reports. In this case study, journal publications provided insufficient information on harms outcomes of clinical trials and did not specify that a subset of harms data were being presented. Clinical study reports often present data on harms, including serious adverse events, which are not reported or mentioned in the journal publications. Therefore, clinical study reports could support a more complete, accurate, and reliable investigation, and researchers undertaking evidence synthesis of harm outcomes should not rely only on incomplete published data that are presented in the journal publications.
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Reporting Guidelines for Clinical Pharmacokinetic Studies: The ClinPK Statement.
Kanji, Salmaan; Hayes, Meghan; Ling, Adam; Shamseer, Larissa; Chant, Clarence; Edwards, David J; Edwards, Scott; Ensom, Mary H H; Foster, David R; Hardy, Brian; Kiser, Tyree H; la Porte, Charles; Roberts, Jason A; Shulman, Rob; Walker, Scott; Zelenitsky, Sheryl; Moher, David
2015-07-01
Transparent reporting of all research is essential for assessing the validity of any study. Reporting guidelines are available and endorsed for many types of research but are lacking for clinical pharmacokinetic studies. Such tools promote the consistent reporting of a minimal set of information for end users, and facilitate knowledge translation of research. The objective of this study was to create a guideline to assist in the transparent and complete reporting of clinical pharmacokinetic studies. Preliminary content to be considered was identified from a systematic search of the literature and regulatory documents. Stakeholders were identified to participate in a modified Delphi exercise and a virtual meeting to generate consensus for items considered essential in the reporting of clinical pharmacokinetic studies. The proposed checklist was pilot tested on 100 recently published clinical pharmacokinetic studies. Overall and itemized compliance with the proposed guidance was determined for each study. Sixty-eight stakeholders from nine countries consented to participate. Four rounds of a modified Delphi survey and a series of small virtual meetings were required to generate consensus for a 24-item checklist considered to be essential to the reporting of clinical pharmacokinetic studies. When applied to the 100 most recently published clinical pharmacokinetic studies, 45 were determined to be compliant with at least 80 % of the checklist items. Explanatory text was prepared using examples of compliant reporting from these and other relevant studies. The reader's ability to judge the validity of pharmacokinetic research can be greatly compromised by the incomplete reporting of study information. Using consensus methods, we have developed a tool to guide transparent and accurate reporting of clinical pharmacokinetic studies. Endorsement and implementation of these guidelines by researchers, clinicians and journals would promote more consistent reporting of these studies and allow for better assessment of utility for clinical applications.
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Perlis, Roy H; Perlis, Clifford S; Wu, Yelena; Hwang, Cindy; Joseph, Megan; Nierenberg, Andrew A
2005-10-01
Financial conflict of interest has been reported to be prevalent in clinical trials in general medicine and associated with a greater likelihood of reporting results favorable to the intervention being studied. The extent and implications of industry sponsorship and financial conflict of interest in psychiatric clinical trials have not been investigated, to the authors' knowledge. The authors examined funding source and author financial conflict of interest in all clinical trials published in the American Journal of Psychiatry, the Archives of General Psychiatry, the Journal of Clinical Psychopharmacology, and the Journal of Clinical Psychiatry between 2001 and 2003. Among 397 clinical trials identified, 239 (60%) reported receiving funding from a pharmaceutical company or other interested party, and 187 studies (47%) included at least one author with a reported financial conflict of interest. Among the 162 randomized, double-blind, placebo-controlled studies examined, those that reported conflict of interest were 4.9 times more likely to report positive results; this association was significant only among the subset of pharmaceutical industry-funded studies. Author conflict of interest appears to be prevalent among psychiatric clinical trials and to be associated with a greater likelihood of reporting a drug to be superior to placebo.
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Rieves, Dwaine; Jacobs, Paula
2016-12-01
Pharmaceutical companies typically perform prospective, multicenter phase 3 clinical studies to support approval of a new imaging agent by the U.S. Food and Drug Administration (FDA). In uncommon situations, the FDA has approved imaging agents based solely, or in large part, on the clinical study experience described in published reports, including reports of exploratory (i.e., phase 1 or 2) studies performed at a single clinical site. We performed a survey of published reports to assess the potential of the reported information to support FDA approval of a commonly cited investigational imaging agent. Our survey revealed critical data limitations in most publications, all of which reported exploratory clinical studies. Here we summarize the precedent for FDA approval of imaging agents using effectiveness data from publications, FDA guidance, and our experience in reviewing publications. We also present a key-data checklist for investigators to consider in the design, conduct, and reporting of exploratory clinical studies for publication. We encourage editors and peer reviewers to consider requiring these key data when reviewing these reports for publication. © 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.
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Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C
2014-06-04
To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient's trial identification number. Using the patient's trial identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency for marketing approval. Clinical study reports obtained from the EMA in 2011. Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary, especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used. Data on adverse events in tables in clinical study reports may not accurately represent the underlying patient data because of the medical dictionaries and coding conventions used. In clinical study reports, the listings of adverse events for individual patients and narratives of adverse events can provide additional information, including original investigator reported adverse event terms, which can enable a more accurate estimate of harms. © Maund et al 2014.
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Whale, Katie; Fish, Daniel; Fayers, Peter; Cafaro, Valentina; Pusic, Andrea; Blazeby, Jane M.; Efficace, Fabio
2016-01-01
Purpose Randomised controlled trials (RCTs) are the most robust study design measuring outcomes of colorectal cancer (CRC) treatments, but to influence clinical practice trial design and reporting of patient-reported outcomes (PROs) must be of high quality. Objectives of this study were as follows: to examine the quality of PRO reporting in RCTs of CRC treatment; to assess the availability of robust data to inform clinical decision-making; and to investigate whether quality of reporting improved over time. Methods A systematic review from January 2004–February 2012 identified RCTs of CRC treatment describing PROs. Relevant abstracts were screened and manuscripts obtained. Methodological quality was assessed using International Society for Quality of Life Research—patient-reported outcome reporting standards. Changes in reporting quality over time were established by comparison with previous data, and risk of bias was assessed with the Cochrane risk of bias tool. Results Sixty-six RCTs were identified, seven studies (10 %) reported survival benefit favouring the experimental treatment, 35 trials (53 %) identified differences in PROs between treatment groups, and the clinical significance of these differences was discussed in 19 studies (29 %). The most commonly reported treatment type was chemotherapy (n = 45; 68 %). Improvements over time in key methodological issues including the documentation of missing data and the discussion of the clinical significance of PROs were found. Thirteen trials (20 %) had high-quality reporting. Conclusions Whilst improvements in PRO quality reporting over time were found, several recent studies still fail to robustly inform clinical practice. Quality of PRO reporting must continue to improve to maximise the clinical impact of PRO findings. PMID:25910987
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Revere, Debra; Hills, Rebecca H; Dixon, Brian E; Gibson, P Joseph; Grannis, Shaun J
2017-03-11
The future of notifiable condition reporting in the United States is undergoing a transformation with the increasing development of Health Information Exchanges which support electronic data-sharing and -transfer networks and the wider adoption of electronic laboratory reporting. Communicable disease report forms originating in clinics are an important source of surveillance data for public health agencies. However, problems of poor data quality and delayed submission of reports to public health agencies are common. In addition, studies of barriers and facilitators to reporting have assumed that the primary reporter is the treating physician, although the extent to which a provider is involved in the reporting workflow is unclear. We sought to better understand the barriers to and burden of notifiable condition reporting from the perspectives of the three primary groups involved in reporting workflow: providers, clinic staff who bear the principal responsibility for reporting, and the public health workers who receive and process reports from clinics. In addition, we sought to situate these findings within the context of the future of notifiable disease reporting and the potential impacts of electronic lab and medical records on the surveillance system. Seven ambulatory care clinics and 3 public health agencies that are part of a Health Information Exchange in the state of Indiana, USA, participated in the study. Data were obtained from a survey of clinic physicians (N = 29), interviews with clinic reporters (N = 11), and interviews with public health workers (N = 9). Survey data were summarized descriptively and interview transcripts underwent qualitative analysis. In both clinics and public health agencies, the laboratory report initiates reporting workflow. Provider involvement with reporting primarily revolves around ordering medications to treat a condition confirmed by the lab result. In clinics, reporting is typically the responsibility of clinic reporters who vary in frequency of reporting. We found an association between frequency of reporting, reporting knowledge and perceptions of reporting burden. In both clinics and public health agencies, interruptions and delays in reporting workflow are encountered due to inaccurate or missing information and impact reporting timeliness, data quality and report completeness. Both providers and clinic reporters lack clarity regarding how data submitted by their reports are used by public health agencies. It is possible that the value of reporting may be diminished when those responsible do not perceive receiving benefit in return. This may account for the low awareness of or recollection of public health communications with clinics that we observed. Despite the high likelihood that public health advisories and guidance are based, in part, on data submitted by clinics, a direct concordance may not be recognized. Unlike most studies of notifiable condition reporting, this study included the clinic reporters who bear primary responsibility for completing and submitting reports to public health agencies. A primary barrier to this reporting is timely and easy access to data. It is possible that expanded adoption of electronic health record and laboratory reporting systems will improve access to this data and reduce reporting the burden. However, a complete reliance on automatic electronic extraction of data requires caution and necessitates continued interfacing with clinic reporters for the foreseeable future-particularly for notifiable conditions that are high-impact, uncommon, prone to false positive readings by labs, or are hard to verify. An important finding of this study is the association between frequency of reporting, reporting knowledge and perceptions of reporting burden. Increased automation could result in even lower reporting knowledge and familiarity with reporting requirements which could actually increase reporters' perception of notifiable condition reporting as burdensome. Another finding was of uncertainty regarding how data sent to public health agencies is used or provides clinical benefit. A strong recommendation generated by these findings is that, given their central role in reporting, clinic reporters are a significant target audience for public health outreach and education that aims to alleviate perceived reporting burden and improve reporting knowledge. In particular, communicating the benefits of public health's use of the data may reduce a perceived lack of information reciprocity between clinical and public health organizations.
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Bolia, Ioanna; Utsunomiya, Hajime; Locks, Renato; Briggs, Karen; Philippon, Marc J
2018-01-01
To identify (1) the predominant level of evidence of the clinical studies regarding the hip pathology, risk factors, treatment, and clinical outcomes in artistic athletes (dancers, figure skaters, and gymnasts) (2) the most commonly reported hip pathology, risk factors, treatments, and clinical outcomes in dancers, figure skaters, and gymnasts. To conduct this systematic review PubMed, EMBASE, and Scopus databases were searched for relevant studies and pertinent data were collected from the eligible articles. Included were studies which reported hip injuries in artistic athletes, the risk factors, treatment, and/or the clinical outcomes. We excluded case reports or irrelevant studies. No meta-analysis was performed because of study heterogeneity. The methodical index for nonrandomized studies (MINORS) criteria were used for quality control. Thirty-eight studies were included in the analysis. The mean MINORS score was 13.6 ± 4.6 points indicating fair quality of evidence of the included articles. The predominant level of evidence was level IV. Chondrolabral pathology and muscle injuries were the most commonly reported pathologies. We found only 2 risk factor analysis studies; however, many studies reported risk correlation between artistic sports or imaging findings and hip pathology. Treatment strategies were reported in only 7 studies, clinical outcomes are significantly underreported. Chondrolabral pathology was the most commonly reported hip pathology in artistic athletes, however, prospective cohort studies are necessary to really understand these injuries and their associated risk factors. The lack of clinical outcomes is significant and future data collection is required to assess the effectiveness of the various treatments.
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High School Students' Self-Reported Use of School Clinics and Nurses.
Harper, Christopher R; Liddon, Nicole; Dunville, Richard; Habel, Melissa A
2016-10-01
Access to school health clinics and nurses has been linked with improved student achievement and health. Unfortunately, no studies have examined how many students report using school clinics or nurses and for which services. This study addressed this gap with data from a nationally representative sample of 15- to 25-year-olds. Respondents who reported being in high school were provided a list of services and asked whether they had gone to a school nurse or clinic for any of the listed services. Nearly 90% reported having access to a school clinic or nurse. Among students with access, 65.6% reported using at least one service. Non-White students and younger students were more likely to report having access to a clinic or nurse. These results show many students have access to clinics or nurses and are using these services, although not uniformly for all services. © The Author(s) 2016.
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Science and the art of case reporting in medicine.
Pramono, Laurentius A
2013-10-01
The case report is one type of article published in medical journals. Not all case reports can be published. Case reports worth publishing are case reports that have good teaching points and good clinical messages. Writing case reports need academic and clinical skills, along with a taste of art to interest readers to read and study about the case we report. Case reports are expected to be a good tool to all clinicians to build their clinical reasoning and sharpen their clinical instincts.
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Borgerson, Dawn; Dino, Jennifer
2012-01-01
Clinical research professionals are faced with decreased funding and increased workloads; innovative methods of professional development programs are necessary to accommodate these factors. This study evaluated the feasibility, perceived satisfaction, and value of using webinars to educate clinical research professionals on reporting adverse events commonly experienced in pediatric oncology clinical trials. The setting incorporated synchronous web-based educational technology. Constructivist learning provides the theoretical framework for this study. Participants evaluated the professional development program at 2 time points: (a) at the conclusion and (b) 4 to 6 weeks afterward, using survey method. Synchronous webinars were both economical and effective in educating clinical research professionals across institutional sites. Participants reported exceptionally high levels of satisfaction with the accessibility, scope, quality, and interactivity of the professional development program. The vast majority of participants reported that the education would assist with reporting adverse events in pediatric oncology clinical trials and this perception persisted into clinical practice. Although the results of this study were intended to guide future educational efforts of the Children's Oncology Group, they may also apply to other cooperative groups.
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Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C
2014-01-01
Objective To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. Design Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient’s trial identification number. Using the patient’s trial identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. Setting 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency for marketing approval. Data sources Clinical study reports obtained from the EMA in 2011. Results Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary, especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used. Conclusion Data on adverse events in tables in clinical study reports may not accurately represent the underlying patient data because of the medical dictionaries and coding conventions used. In clinical study reports, the listings of adverse events for individual patients and narratives of adverse events can provide additional information, including original investigator reported adverse event terms, which can enable a more accurate estimate of harms. PMID:24899651
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Prayle, Andrew P; Hurley, Matthew N; Smyth, Alan R
2012-01-03
To examine compliance with mandatory reporting of summary clinical trial results (within one year of completion of trial) on ClinicalTrials.gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation. Registry based study of clinical trial summaries. ClinicalTrials.gov, searched on 19 January 2011, with cross referencing with Drugs@FDA to determine for which trials mandatory reporting was required within one year. Selection criteria Studies registered on ClinicalTrials.gov with US sites which completed between 1 January and 31 December 2009. Proportion of trials for which results had been reported. The ClinicalTrials.gov registry contained 83,579 entries for interventional trials, of which 5642 were completed within the timescale of interest. We identified trials as falling within the mandatory reporting rules if they were covered by the FDAAA (trials of a drug, device, or biological agent, which have at least one US site, and are of phase II or later) and if they investigated a drug that already had approval from the Food and Drug Administration. Of these, 163/738 (22%) had reported results within one year of completion of the trial compared with 76/727 (10%) trials that were not subject to mandatory reporting (95% confidence interval for the difference in proportions 7.8% to 15.5%; χ(2) test, P = 2.6 × 10(-9)). Later phase trials were more likely to report results (P = 4.4 × 10(-11)), as were industry funded trials (P = 2.2 × 10(-16)). Most trials subject to mandatory reporting did not report results within a year of completion.
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A systematic review of clinical audit in companion animal veterinary medicine.
Rose, Nicole; Toews, Lorraine; Pang, Daniel S J
2016-02-26
Clinical audit is a quality improvement process with the goal of continuously improving quality of patient care as assessed by explicit criteria. In human medicine clinical audit has become an integral and required component of the standard of care. In contrast, in veterinary medicine there appear to have been a limited number of clinical audits published, indicating that while clinical audit is recognised, its adoption in veterinary medicine is still in its infancy. A systematic review was designed to report and evaluate the veterinary literature on clinical audit in companion animal species (dog, cat, horse). A systematic search of English and French articles using Proquest Dissertations and Theses database (February 6, 2014), CAB Abstracts (March 21, 2014 and April 4, 2014), Scopus (March 21, 2014), Web of Science Citation index (March 21, 2014) and OVID Medline (March 21, 2014) was performed. Included articles were those either discussing clinical audit (such as review articles and editorials) or reporting parts of, or complete, audit cycles. The majority of articles describing clinical audit were reviews. From 89 articles identified, twenty-one articles were included and available for review. Twelve articles were reviews of clinical audit in veterinary medicine, five articles included at least one veterinary clinical audit, one thesis was identified, one report was of a veterinary clinical audit website and two articles reported incomplete clinical audits. There was no indication of an increase in the number of published clinical audits since the first report in 1998. However, there was evidence of article misclassification, with studies fulfilling the criteria of clinical audit not appropriately recognised. Quality of study design and reporting of findings varied considerably, with information missing on key components, including duration of study, changes in practice implemented between audits, development of explicit criteria and appropriate statistical analyses. Available evidence suggests the application and reporting of clinical audit in veterinary medicine is sporadic despite the potential to improve patient care, though the true incidence of clinical audit reporting is likely to be underestimated due to incorrect indexing. Reporting standards of clinical audits are highly variable, limiting evaluation, application and repeatability of published work.
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Trocky, NM; Fontinha, M
2005-01-01
Data collected throughout the course of a clinical research trial must be reviewed for accuracy and completeness continually. The Oracle Clinical® (OC) data management application utilized to capture clinical data facilitates data integrity through pre-programmed validations, edit and range checks, and discrepancy management modules. These functions were not enough. Coupled with the use of specially created reports in Oracle Discoverer® and Integrated Review TM, both ad-hoc query and reporting tools, research staff have enhanced their ability to clean, analyze and report more accurate data captured within and among Case Report Forms (eCRFs) by individual study or across multiple studies. PMID:16779428
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Earley, Amy; Lau, Joseph; Uhlig, Katrin
2013-01-18
A participant death is a serious event in a clinical trial and needs to be unambiguously and publicly reported. To examine (1) how often and how numbers of deaths are reported in ClinicalTrials.gov records; (2) how often total deaths can be determined per arm within a ClinicalTrials.gov results record and its corresponding publication and (3) whether counts may be discordant. Registry-based study of clinical trial results reporting. ClinicalTrials.gov results database searched in July 2011 and matched PubMed publications. A random sample of ClinicalTrials.gov results records. Detailed review of records with a single corresponding publication. ClinicalTrials.gov records reporting number of deaths under participant flow, primary or secondary outcome or serious adverse events. Consistency in reporting of number of deaths between ClinicalTrials.gov records and corresponding publications. In 500 randomly selected ClinicalTrials.gov records, only 123 records (25%) reported a number for deaths. Reporting of deaths across data modules for participant flow, primary or secondary outcomes and serious adverse events was variable. In a sample of 27 pairs of ClinicalTrials.gov records with number of deaths and corresponding publications, total deaths per arm could only be determined in 56% (15/27 pairs) but were discordant in 19% (5/27). In 27 pairs of ClinicalTrials.gov records without any information on number of deaths, 48% (13/27) were discordant since the publications reported absence of deaths in 33% (9/27) and positive death numbers in 15% (4/27). Deaths are variably reported in ClinicalTrials.gov records. A reliable total number of deaths per arm cannot always be determined with certainty or can be discordant with number reported in corresponding trial publications. This highlights a need for unambiguous and complete reporting of the number of deaths in trial registries and publications.
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Earley, Amy; Lau, Joseph; Uhlig,, Katrin
2013-01-01
Context A participant death is a serious event in a clinical trial and needs to be unambiguously and publicly reported. Objective To examine (1) how often and how numbers of deaths are reported in ClinicalTrials.gov records; (2) how often total deaths can be determined per arm within a ClinicalTrials.gov results record and its corresponding publication and (3) whether counts may be discordant. Design Registry-based study of clinical trial results reporting. Setting ClinicalTrials.gov results database searched in July 2011 and matched PubMed publications. Selection criteria A random sample of ClinicalTrials.gov results records. Detailed review of records with a single corresponding publication. Main outcome measure ClinicalTrials.gov records reporting number of deaths under participant flow, primary or secondary outcome or serious adverse events. Consistency in reporting of number of deaths between ClinicalTrials.gov records and corresponding publications. Results In 500 randomly selected ClinicalTrials.gov records, only 123 records (25%) reported a number for deaths. Reporting of deaths across data modules for participant flow, primary or secondary outcomes and serious adverse events was variable. In a sample of 27 pairs of ClinicalTrials.gov records with number of deaths and corresponding publications, total deaths per arm could only be determined in 56% (15/27 pairs) but were discordant in 19% (5/27). In 27 pairs of ClinicalTrials.gov records without any information on number of deaths, 48% (13/27) were discordant since the publications reported absence of deaths in 33% (9/27) and positive death numbers in 15% (4/27). Conclusions Deaths are variably reported in ClinicalTrials.gov records. A reliable total number of deaths per arm cannot always be determined with certainty or can be discordant with number reported in corresponding trial publications. This highlights a need for unambiguous and complete reporting of the number of deaths in trial registries and publications. PMID:23335556
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Jansen, Marleen E; Rigter, T; Rodenburg, W; Fleur, T M C; Houwink, E J F; Weda, M; Cornel, Martina C
2017-01-01
Advances from pharmacogenetics (PGx) have not been implemented into health care to the expected extent. One gap that will be addressed in this study is a lack of reporting on clinical validity and clinical utility of PGx-tests. A systematic review of current reporting in scientific literature was conducted on publications addressing PGx in the context of statins and muscle toxicity. Eighty-nine publications were included and information was selected on reported measures of effect, arguments, and accompanying conclusions. Most authors report associations to quantify the relationship between a genetic variation an outcome, such as adverse drug responses. Conclusions on the implementation of a PGx-test are generally based on these associations, without explicit mention of other measures relevant to evaluate the test's clinical validity and clinical utility. To gain insight in the clinical impact and select useful tests, additional outcomes are needed to estimate the clinical validity and utility, such as cost-effectiveness.
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Feldmeier, J J; Heimbach, R D; Davolt, D A; Brakora, M J; Sheffield, P J; Porter, A T
1994-12-01
We reviewed all known published reports or studies related to a possible cancer-causing or growth-enhancing effect by hyperbaric oxygen. Published articles were retrieved using Medline searches for the period 1960-1993. Additional references were obtained from bibliographies included in those articles discovered in the computer search. Also, hyperbaric medicine text books and the published proceedings of international hyperbaric conferences were visually searched. Studies and reports discovered in this fashion and related to the topic were included in the review. Twenty-four references were found: 12 were clinical reports, 11 were animal studies, and 1 reported both an animal study and a clinical report. Three clinical reports suggested a positive cancer growth enhancement, whereas 10 clinical reports showed no cancer growth enhancement. Two animal studies suggested a positive cancer-enhancing effect, and 10 animal studies showed no such effect. (The report that included both animals and humans is counted in both groups). The vast majority of published reports show no cancer growth enhancement by HBO exposure. Those studies that do show growth enhancement are refuted by larger subsequent studies, are mixed studies, or are highly anecdotal. A review of published information fails to support a cancer-causing or growth-enhancing effect by HBO.
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Compliance with results reporting at ClinicalTrials.gov.
Anderson, Monique L; Chiswell, Karen; Peterson, Eric D; Tasneem, Asba; Topping, James; Califf, Robert M
2015-03-12
The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials with publicly available results and determined independent factors associated with the reporting of results. Using an algorithm based on input from the National Library of Medicine, we identified trials that were likely to be subject to FDAAA provisions (highly likely applicable clinical trials, or HLACTs) from 2008 through 2013. We determined the proportion of HLACTs that reported results within the 12-month interval mandated by the FDAAA or at any time during the 5-year study period. We used regression models to examine characteristics associated with reporting at 12 months and throughout the 5-year study period. From all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions. Despite ethical and legal obligations to disclose findings promptly, most HLACTs did not report results to ClinicalTrials.gov in a timely fashion during the study period. Industry-funded trials adhered to legal obligations more often than did trials funded by the NIH or other government or academic institutions. (Funded by the Clinical Trials Transformation Initiative and the NIH.).
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Morales-Mendoza, Yamilett; Fernández-Martínez, Ramón; Fabián-Victoriano, Ma Rosy; Contreras-Ruiz, José; Vásquez-del-Mercado, Elsa; de Lourdes Suárez-Roa, Maria; Arenas-Guzman, Roberto
2014-11-01
The reported prevalence of candidiasis in peristomal skin varies greatly. Very few studies exist that correlate the clinical findings around the peristomal skin to the mycology. In this study, the authors report on Candida species prevalence, clinical correlation, and mycology.
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Adherence to Standards for Reporting Diagnostic Accuracy in Emergency Medicine Research.
Gallo, Lucas; Hua, Nadia; Mercuri, Mathew; Silveira, Angela; Worster, Andrew
2017-08-01
Diagnostic tests are used frequently in the emergency department (ED) to guide clinical decision making and, hence, influence clinical outcomes. The Standards for Reporting of Diagnostic Accuracy (STARD) criteria were developed to ensure that diagnostic test studies are performed and reported to best inform clinical decision making in the ED. The objective was to determine the extent to which diagnostic studies published in emergency medicine journals adhered to STARD 2003 criteria. Diagnostic studies published in eight MEDLINE-listed, peer-reviewed, emergency medicine journals over a 5-year period were reviewed for compliance to STARD criteria. A total of 12,649 articles were screened and 114 studies were included in our study. Twenty percent of these were randomly selected for assessment using STARD 2003 criteria. Adherence to STARD 2003 reporting standards for each criteria ranged from 8.7% adherence (criteria-reporting adverse events from performing index test or reference standard) to 100% (multiple criteria). Just over half of STARD criteria are reported in more than 80% studies. As poorly reported studies may negatively impact their clinical usefulness, it is essential that studies of diagnostic test accuracy be performed and reported adequately. Future studies should assess whether studies have improved compliance with the STARD 2015 criteria amendment. © 2017 by the Society for Academic Emergency Medicine.
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The CARE guidelines: consensus-based clinical case reporting guideline development
Gagnier, Joel J; Kienle, Gunver; Altman, Douglas G; Moher, David; Sox, Harold; Riley, David
2013-01-01
A case report is a narrative that describes, for medical, scientific or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) premeeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines and (3) postmeeting feedback, review and pilot testing, followed by finalisation of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist—a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. PMID:24155002
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Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.
Shepshelovich, D; Goldvaser, H; Wang, L; Abdul Razak, A R; Bedard, P L
2017-12-01
Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (p<0.001), multicenter trials (p<0.001) and publication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.
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Lee, Jong Woo; LaRoche, Suzette; Choi, Hyunmi; Rodriguez Ruiz, Andres A; Fertig, Evan; Politsky, Jeffrey M; Herman, Susan T; Loddenkemper, Tobias; Sansevere, Arnold J; Korb, Pearce J; Abend, Nicholas S; Goldstein, Joshua L; Sinha, Saurabh R; Dombrowski, Keith E; Ritzl, Eva K; Westover, Michael B; Gavvala, Jay R; Gerard, Elizabeth E; Schmitt, Sarah E; Szaflarski, Jerzy P; Ding, Kan; Haas, Kevin F; Buchsbaum, Richard; Hirsch, Lawrence J; Wusthoff, Courtney J; Hopp, Jennifer L; Hahn, Cecil D
2016-04-01
The rapid expansion of the use of continuous critical care electroencephalogram (cEEG) monitoring and resulting multicenter research studies through the Critical Care EEG Monitoring Research Consortium has created the need for a collaborative data sharing mechanism and repository. The authors describe the development of a research database incorporating the American Clinical Neurophysiology Society standardized terminology for critical care EEG monitoring. The database includes flexible report generation tools that allow for daily clinical use. Key clinical and research variables were incorporated into a Microsoft Access database. To assess its utility for multicenter research data collection, the authors performed a 21-center feasibility study in which each center entered data from 12 consecutive intensive care unit monitoring patients. To assess its utility as a clinical report generating tool, three large volume centers used it to generate daily clinical critical care EEG reports. A total of 280 subjects were enrolled in the multicenter feasibility study. The duration of recording (median, 25.5 hours) varied significantly between the centers. The incidence of seizure (17.6%), periodic/rhythmic discharges (35.7%), and interictal epileptiform discharges (11.8%) was similar to previous studies. The database was used as a clinical reporting tool by 3 centers that entered a total of 3,144 unique patients covering 6,665 recording days. The Critical Care EEG Monitoring Research Consortium database has been successfully developed and implemented with a dual role as a collaborative research platform and a clinical reporting tool. It is now available for public download to be used as a clinical data repository and report generating tool.
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How to report a research study.
Cronin, Paul; Rawson, James V; Heilbrun, Marta E; Lee, Janie M; Kelly, Aine M; Sanelli, Pina C; Bresnahan, Brian W; Paladin, Angelisa M
2014-09-01
Incomplete reporting hampers the evaluation of results and bias in clinical research studies. Guidelines for reporting study design and methods have been developed to encourage authors and journals to include the required elements. Recent efforts have been made to standardize the reporting of clinical health research including clinical guidelines. In this article, the reporting of diagnostic test accuracy studies, screening studies, therapeutic studies, systematic reviews and meta-analyses, cost-effectiveness assessments (CEA), recommendations and/or guidelines, and medical education studies is discussed. The available guidelines, many of which can be found at the Enhancing the QUAlity and Transparency Of health Research network, on how to report these different types of health research are also discussed. We also hope that this article can be used in academic programs to educate the faculty and trainees of the available resources to improve our health research. Copyright © 2014 AUR. Published by Elsevier Inc. All rights reserved.
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Wallach, Joshua D; Egilman, Alexander C; Dhruva, Sanket S; McCarthy, Margaret E; Miller, Jennifer E; Woloshin, Steven; Schwartz, Lisa M; Ross, Joseph S
2018-05-24
To characterize postmarketing requirements for new drugs and biologics approved by the US Food and Drug Administration (FDA), and to examine rates and timeliness of registration, results reporting, and publication of required prospective cohort studies, registries, and clinical trials. Cross sectional analysis. Postmarketing requirements for all new drugs and biologics approved by the FDA between 1 January 2009 and 31 December 2012, with follow-up up to 15 November 2017. Postmarketing requirements and their characteristics known at the time of FDA approval, including FDA authority, study design, and study characteristics. Rates and timeliness of registration and results reporting on ClinicalTrials.gov and publication in peer reviewed journals of required prospective cohort studies, registries, and clinical trials. Between 2009 and 12, the FDA approved 97 new drugs and biologics for 106 indications with at least one postmarketing requirement at the time of first approval, for a total of 437 postmarketing requirements. Postmarket study descriptions were short (median word count 44 (interquartile range 29-71)) and often lacked information to determine an up to date progress (131 (30%)). 220 (50.3%) postmarketing requirements were for new animal or other studies (including pharmacokinetic studies); 134 (30.7%) were for prospective cohort studies, registries, and clinical trials; and 83 (19.0%) were for secondary analyses or follow-up studies. Of 110 clinical trials, 38 (34.5%), 44 (40.0%), 62 (56.4%), 66 (60.0%), and 98 (89.1%) did not report enough information to establish use of randomization, comparator type, allocation, outcome, and number of patients to be enrolled, respectively. Of 134 required prospective cohort studies, registries, and clinical trials, 102 (76.1%) were registered on ClinicalTrials.gov; of 50 registered and completed studies, 36 (72.0%) had reported results on ClinicalTrials.gov. Among 65 completed studies, 47 (72.3%) had either reported results or were published a median of 47 months (interquartile range 32-67) after FDA approval. 32 (68.1%) of these 47 studies did not report results publicly by the time of their original FDA report submission deadline. Postmarketing requirements for new drugs and biologics were often briefly described and did not contain enough information to characterize study designs. Approximately three quarters of postmarketing requirements for prospective cohort studies, registries, and clinical trials were registered on ClinicalTrials.gov, and nearly three quarters of completed studies reported results or were published, suggesting that at least a quarter of these required studies are not being publicly disseminated. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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Ban, Jong-Wook; Emparanza, José Ignacio; Urreta, Iratxe; Burls, Amanda
2016-01-01
Background Many new clinical prediction rules are derived and validated. But the design and reporting quality of clinical prediction research has been less than optimal. We aimed to assess whether design characteristics of validation studies were associated with the overestimation of clinical prediction rules’ performance. We also aimed to evaluate whether validation studies clearly reported important methodological characteristics. Methods Electronic databases were searched for systematic reviews of clinical prediction rule studies published between 2006 and 2010. Data were extracted from the eligible validation studies included in the systematic reviews. A meta-analytic meta-epidemiological approach was used to assess the influence of design characteristics on predictive performance. From each validation study, it was assessed whether 7 design and 7 reporting characteristics were properly described. Results A total of 287 validation studies of clinical prediction rule were collected from 15 systematic reviews (31 meta-analyses). Validation studies using case-control design produced a summary diagnostic odds ratio (DOR) 2.2 times (95% CI: 1.2–4.3) larger than validation studies using cohort design and unclear design. When differential verification was used, the summary DOR was overestimated by twofold (95% CI: 1.2 -3.1) compared to complete, partial and unclear verification. The summary RDOR of validation studies with inadequate sample size was 1.9 (95% CI: 1.2 -3.1) compared to studies with adequate sample size. Study site, reliability, and clinical prediction rule was adequately described in 10.1%, 9.4%, and 7.0% of validation studies respectively. Conclusion Validation studies with design shortcomings may overestimate the performance of clinical prediction rules. The quality of reporting among studies validating clinical prediction rules needs to be improved. PMID:26730980
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Ban, Jong-Wook; Emparanza, José Ignacio; Urreta, Iratxe; Burls, Amanda
2016-01-01
Many new clinical prediction rules are derived and validated. But the design and reporting quality of clinical prediction research has been less than optimal. We aimed to assess whether design characteristics of validation studies were associated with the overestimation of clinical prediction rules' performance. We also aimed to evaluate whether validation studies clearly reported important methodological characteristics. Electronic databases were searched for systematic reviews of clinical prediction rule studies published between 2006 and 2010. Data were extracted from the eligible validation studies included in the systematic reviews. A meta-analytic meta-epidemiological approach was used to assess the influence of design characteristics on predictive performance. From each validation study, it was assessed whether 7 design and 7 reporting characteristics were properly described. A total of 287 validation studies of clinical prediction rule were collected from 15 systematic reviews (31 meta-analyses). Validation studies using case-control design produced a summary diagnostic odds ratio (DOR) 2.2 times (95% CI: 1.2-4.3) larger than validation studies using cohort design and unclear design. When differential verification was used, the summary DOR was overestimated by twofold (95% CI: 1.2 -3.1) compared to complete, partial and unclear verification. The summary RDOR of validation studies with inadequate sample size was 1.9 (95% CI: 1.2 -3.1) compared to studies with adequate sample size. Study site, reliability, and clinical prediction rule was adequately described in 10.1%, 9.4%, and 7.0% of validation studies respectively. Validation studies with design shortcomings may overestimate the performance of clinical prediction rules. The quality of reporting among studies validating clinical prediction rules needs to be improved.
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Miranda, I; Sánchez-Alepuz, E; Lucas, F J; Carratalá, V; González-Jofre, C A
To analyze the current scientific and/or clinical evidence supporting the use of platelet-rich plasma (PRP) in the treatment of rotator cuff pathology. After a systematic review in PubMed, studies assessing PRP efficacy in the treatment of rotator cuff pathology published since 2013 to date were identified. Data were grouped based on type of study (laboratory, clinical or meta-analysis); accordingly study design, pathology treated and clinical outcomes were summarized. Thirty five articles have been analyzed: 10 laboratory studies, 17 clinical assays and 8 meta-analyses. While laboratory studies report positive or partially positive results for the use of PRP, 70.6% of clinical studies and 75% of meta-analysis found no statistically significant differences between the PRP group and the control group. The positive results of laboratory studies do not translate well to clinical practice. There is no concordance among the few positive results reported in the clinical studies, and even some contradictory effects have been reported. There is no solid scientific and/or clinical evidence supporting the use of PRP in the treatment of rotator cuff pathology in routine clinical practice. Copyright © 2017 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.
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Eisenstein, Eric L; Diener, Lawrence W; Nahm, Meredith; Weinfurt, Kevin P
2011-12-01
New technologies may be required to integrate the National Institutes of Health's Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies.
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Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.
2013-01-01
New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies. PMID:20703765
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Impact of voice- and knowledge-enabled clinical reporting--US example.
Bushko, Renata G; Havlicek, Penny L; Deppert, Edward; Epner, Stephen
2002-01-01
This study shows qualitative and quantitative estimates of the national and the clinic level impact of utilizing voice and knowledge enabled clinical reporting systems. Using common sense estimation methodology, we show that the delivery of health care can experience a dramatic improvement in four areas as a result of the broad use of voice and knowledge enabled clinical reporting: (1) Process Quality as measured by cost savings, (2) Organizational Quality as measured by compliance, (3) Clinical Quality as measured by clinical outcomes and (4) Service Quality as measured by patient satisfaction. If only 15 percent of US physicians replaced transcription with modem clinical reporting voice-based methodology, about one half billion dollars could be saved. $6.7 Billion could be saved annually if all medical reporting currently transcribed was handled with voice-and knowledge-enabled dictation and reporting systems.
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Paolino, Nathalie D; Artino, Anthony R; Saguil, Aaron; Dong, Ting; Durning, Steven J; DeZee, Kent J
2015-04-01
This article explores specific aspects of self-reported clinical and research experience and their relationship to performance in medical training. This is a retrospective cohort study conducted at the Uniformed Services University. The American Medical College Application Service application was used to discern students' self-reported clinical and research experience. Two authors applied a classification scheme for clinical and research experience to the self-reported experiences. Study outcomes included medical school grade point average (GPA), U.S. Medical Licensing Examination (USMLE) scores, and intern expertise and professionalism scores. A linear regression analysis was conducted for each outcome while controlling for prematriculation GPA. Data were retrieved on 1,020 matriculants. There were several statistically significant but small differences across outcomes when comparing the various categories of clinical experience with no clinical experience. The technician-level experience group had a decrease of 0.1 in cumulative GPA in comparison to students without self-reported clinical experience (p = 0.004). This group also performed 5 points lower on the USMLE Step 2 than students who did not report clinical experience (p = 0.013). The various levels of self-reported research experience were unrelated to success in medical school and graduate medical education. These findings indicate that self-reported technician-level clinical experience is related to a small reduction in typically reported outcomes in medical school. Reprint & Copyright © 2015 Association of Military Surgeons of the U.S.
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Ramagopalan, Sreeram V; Skingsley, Andrew P; Handunnetthi, Lahiru; Magnus, Daniel; Klingel, Michelle; Pakpoor, Julia; Goldacre, Ben
2015-01-01
We and others have shown a significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. The objectives of this study were to investigate whether changes made to primary outcomes are associated with the likelihood of reporting a statistically significant primary outcome on ClinicalTrials.gov. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 20 November 2014 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. 13,238 completed interventional trials were registered with ClinicalTrials.gov that also had study results posted on the website. 2555 (19.3%) had one or more statistically significant primary outcomes. Statistical analysis showed that registration year, funding source and primary outcome change after trial completion were associated with reporting a statistically significant primary outcome . Funding source and primary outcome change after trial completion are associated with a statistically significant primary outcome report on clinicaltrials.gov.
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Rice, Andrew S C; Morland, Rosemary; Huang, Wenlong; Currie, Gillian L; Sena, Emily S; Macleod, Malcolm R
2017-12-29
Clear reporting of research is crucial to the scientific process. Poorly designed and reported studies are damaging not only to the efforts of individual researchers, but also to science as a whole. Standardised reporting methods, such as those already established for reporting randomised clinical trials, have led to improved study design and facilitated the processes of clinical systematic review and meta-analysis. Such standards were lacking in the pre-clinical field until the development of the ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines. These were prompted following a survey which highlighted a widespread lack of robust and consistent reporting of pre-clinical in vivo research, with reports frequently omitting basic information required for study replication and quality assessment. The resulting twenty item checklist in ARRIVE covers all aspects of experimental design with particular emphasis on bias reduction and methodological transparency. Influential publishers and research funders have already adopted ARRIVE. Further dissemination and acknowledgement of the importance of these guidelines is vital to their widespread implementation. Conclusions and implications Wide implementation of the ARRIVE guidelines for reporting of in vivo preclinical research, especially pain research, are essential for a much needed increased transparency and quality in publishing such research. ARRIVE will also positively influence improvements in experimental design and quality, assist the conduct of accurate replication studies of important new findings and facilitate meta-analyses of preclinical research.
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Scherer, Roberta W; Huynh, Lynn; Ervin, Ann-Margret; Taylor, Jakeisha; Dickersin, Kay
2013-06-18
The inclusion of randomized controlled trials (RCTs) reported in conference abstracts in systematic reviews is controversial, partly because study design information and risk of bias is often not fully reported in the abstract. The Association for Research in Vision and Ophthalmology (ARVO) requires trial registration of abstracts submitted for their annual conference as of 2007. Our goal was to assess the feasibility of obtaining study design information critical to systematic reviews, but not typically included in conference abstracts, from the trial registration record. We reviewed all conference abstracts presented at the ARVO meetings from 2007 through 2009, and identified 496 RCTs; 154 had a single matching registration record in ClinicalTrials.gov. Two individuals independently extracted information from the abstract and the ClinicalTrials.gov record, including study design, sample size, inclusion criteria, masking, interventions, outcomes, funder, and investigator name and contact information. Discrepancies were resolved by consensus. We assessed the frequencies of reporting variables appearing in the abstract and the trial register and assessed agreement of information reported in both sources. We found a substantial amount of study design information in the ClinicalTrials.gov record that was unavailable in the corresponding conference abstract, including eligibility criteria associated with gender (83%; 128/154); masking or blinding of study participants (53%, 82/154), persons administering treatment (30%, 46/154), and persons measuring the outcomes (40%, 61/154)); and number of study centers (58%; 90/154). Only 34% (52/154) of abstracts explicitly described a primary outcome, but a primary outcome was included in the "Primary Outcome" field in the ClinicalTrials.gov record for 82% (126/154) of studies. One or more study interventions were reported in each abstract, but agreed exactly with those reported in ClinicalTrials.gov only slightly more than half the time (88/154, 56%). We found no contact information for study investigators in the abstract, but this information was available in less than one quarter of ClinicalTrial.gov records (17%; 26/154). RCT design information not reported in conference abstracts is often available in the corresponding ClinicalTrials.gov registration record. Sometimes there is conflicting information reported in the two sources and further contact with the trial investigators may still be required.
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2013-01-01
Background The inclusion of randomized controlled trials (RCTs) reported in conference abstracts in systematic reviews is controversial, partly because study design information and risk of bias is often not fully reported in the abstract. The Association for Research in Vision and Ophthalmology (ARVO) requires trial registration of abstracts submitted for their annual conference as of 2007. Our goal was to assess the feasibility of obtaining study design information critical to systematic reviews, but not typically included in conference abstracts, from the trial registration record. Methods We reviewed all conference abstracts presented at the ARVO meetings from 2007 through 2009, and identified 496 RCTs; 154 had a single matching registration record in ClinicalTrials.gov. Two individuals independently extracted information from the abstract and the ClinicalTrials.gov record, including study design, sample size, inclusion criteria, masking, interventions, outcomes, funder, and investigator name and contact information. Discrepancies were resolved by consensus. We assessed the frequencies of reporting variables appearing in the abstract and the trial register and assessed agreement of information reported in both sources. Results We found a substantial amount of study design information in the ClinicalTrials.gov record that was unavailable in the corresponding conference abstract, including eligibility criteria associated with gender (83%; 128/154); masking or blinding of study participants (53%, 82/154), persons administering treatment (30%, 46/154), and persons measuring the outcomes (40%, 61/154)); and number of study centers (58%; 90/154). Only 34% (52/154) of abstracts explicitly described a primary outcome, but a primary outcome was included in the “Primary Outcome” field in the ClinicalTrials.gov record for 82% (126/154) of studies. One or more study interventions were reported in each abstract, but agreed exactly with those reported in ClinicalTrials.gov only slightly more than half the time (88/154, 56%). We found no contact information for study investigators in the abstract, but this information was available in less than one quarter of ClinicalTrial.gov records (17%; 26/154). Conclusion RCT design information not reported in conference abstracts is often available in the corresponding ClinicalTrials.gov registration record. Sometimes there is conflicting information reported in the two sources and further contact with the trial investigators may still be required. PMID:23773868
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Media Reporting of Practice-Changing Clinical Trials in Oncology: A North American Perspective
Vickers, Michael M.; O’Connor, Stephen; Valdes, Mario; Tang, Patricia A.
2016-01-01
Introduction. Media reporting of clinical trials impacts patient-oncologist interactions. We sought to characterize the accuracy of media and Internet reporting of practice-changing clinical trials in oncology. Materials and Methods. The first media articles referencing 17 practice-changing clinical trials were collected from 4 media outlets: newspapers, cable news, cancer websites, and industry websites. Measured outcomes were media reporting score, social media score, and academic citation score. The media reporting score was a measure of completeness of information detailed in media articles as scored by a 15-point scoring instrument. The social media score represented the ubiquity of social media presence referencing 17 practice-changing clinical trials in cancer as determined by the American Society of Clinical Oncology in its annual report, entitled Clinical Cancer Advances 2012; social media score was calculated from Twitter, Facebook, and Google searches. The academic citation score comprised total citations from Google Scholar plus the Scopus database, which represented the academic impact per clinical cancer advance. Results. From 170 media articles, 107 (63%) had sufficient data for analysis. Cohen’s κ coefficient demonstrated reliability of the media reporting score instrument with a coefficient of determination of 94%. Per the media reporting score, information was most complete from industry, followed by cancer websites, newspapers, and cable news. The most commonly omitted items, in descending order, were study limitations, exclusion criteria, conflict of interest, and other. The social media score was weakly correlated with academic citation score. Conclusion. Media outlets appear to have set a low bar for coverage of many practice-changing advances in oncology, with reports of scientific breakthroughs often omitting basic study facts and cautions, which may mislead the public. The media should be encouraged to use a standardized reporting template and provide accessible references to original source information whenever feasible. Implications for Practice: North American newspapers, cable news, cancer websites, and industry websites were searched for their reporting on 17 practice-changing clinical trials in oncology as highlighted by the American Society of Clinical Oncology in its 2012 annual report, Clinical Cancer Advances. Accuracy of reporting across media platforms was evaluated, and the social media buzz and academic interest generated by each clinical trial was gauged. The findings represent, to the authors’ knowledge, the first systematic effort to appraise the reporting of practice-changing clinical trials in oncology across various media platforms. Use of a standardized reporting template by the media is proposed to reduce flaws in their reporting of clinical trials to the public. PMID:26921290
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High School Students' Self-Reported Use of School Clinics and Nurses
ERIC Educational Resources Information Center
Harper, Christopher R.; Liddon, Nicole; Dunville, Richard; Habel, Melissa A.
2016-01-01
Access to school health clinics and nurses has been linked with improved student achievement and health. Unfortunately, no studies have examined how many students report using school clinics or nurses and for which services. This study addressed this gap with data from a nationally representative sample of 15- to 25-year-olds. Respondents who…
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Value and usability of unpublished data sources for systematic reviews and network meta-analyses.
Halfpenny, Nicholas James Anthony; Quigley, Joan Mary; Thompson, Juliette Catherine; Scott, David Alexander
2016-12-01
Peer-reviewed publications and conference proceedings are the mainstay of data sources for systematic reviews and network meta-analyses (NMA), but access to informative unpublished data is now becoming commonplace. To explore the usefulness of three types of 'grey' literature-clinical trials registries, clinical study reports and data from regulatory authorities-we conducted four case studies. The reporting of outcome data in peer-reviewed publications, the clinical trials registries and the clinical study reports for two clinical trials-one in melanoma, one in juvenile idiopathic arthritis (JIA)-was examined. In addition, we assessed the value of including unpublished data from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) in evidence syntheses of hepatitis C virus (HCV) and chronic obstructive pulmonary disease (COPD), respectively. For the clinical trials in melanoma and JIA, we identified outcome parameters on ClinicalTrials.gov additional to those reported in the peer-reviewed publications: subgroup data and additional efficacy end points/extended follow-up, respectively. The clinical study report also provided results for several subgroups unavailable elsewhere. For HCV and COPD, additional outcome data were obtained from the EMA European Public Assessment Report (EPAR) and the FDA, respectively, including data on subgroups and mortality. We conclude that data from these grey literature sources have the potential to influence results of systematic reviews and NMAs, and may thus have implications for healthcare decisions. However, it is important to consider carefully the availability, reliability and consequent usability of these data sources in systematic reviews and NMAs. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
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The CARE guidelines: consensus-based clinical case report guideline development.
Gagnier, Joel J; Kienle, Gunver; Altman, Douglas G; Moher, David; Sox, Harold; Riley, David
2014-01-01
A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate, and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) pre-meeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) post-meeting feedback, review, and pilot testing, followed by finalization of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist-a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. Copyright © 2014 Reproduced with permission of Global Advances in Health and Medicine. Published by Elsevier Inc. All rights reserved.
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Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010.
Califf, Robert M; Zarin, Deborah A; Kramer, Judith M; Sherman, Rachel E; Aberle, Laura H; Tasneem, Asba
2012-05-02
Recent reports highlight gaps between guidelines-based treatment recommendations and evidence from clinical trials that supports those recommendations. Strengthened reporting requirements for studies registered with ClinicalTrials.gov enable a comprehensive evaluation of the national trials portfolio. To examine fundamental characteristics of interventional clinical trials registered in the ClinicalTrials.gov database. A data set comprising 96,346 clinical studies from ClinicalTrials.gov was downloaded on September 27, 2010, and entered into a relational database to analyze aggregate data. Interventional trials were identified and analyses were focused on 3 clinical specialties-cardiovascular, mental health, and oncology-that together encompass the largest number of disability-adjusted life-years lost in the United States. Characteristics of registered clinical trials as reported data elements in the trial registry; how those characteristics have changed over time; differences in characteristics as a function of clinical specialty; and factors associated with use of randomization, blinding, and data monitoring committees (DMCs). The number of registered interventional clinical trials increased from 28,881 (October 2004-September 2007) to 40,970 (October 2007-September 2010), and the number of missing data elements has generally declined. Most interventional trials registered between 2007 and 2010 were small, with 62% enrolling 100 or fewer participants. Many clinical trials were single-center (66%; 24,788/37,520) and funded by organizations other than industry or the National Institutes of Health (NIH) (47%; 17,592/37,520). Heterogeneity in the reported methods by clinical specialty; sponsor type; and the reported use of DMCs, randomization, and blinding was evident. For example, reported use of DMCs was less common in industry-sponsored vs NIH-sponsored trials (adjusted odds ratio [OR], 0.11; 95% CI, 0.09-0.14), earlier-phase vs phase 3 trials (adjusted OR, 0.83; 95% CI, 0.76-0.91), and mental health trials vs those in the other 2 specialties. In similar comparisons, randomization and blinding were less frequently reported in earlier-phase, oncology, and device trials. Clinical trials registered in ClinicalTrials.gov are dominated by small trials and contain significant heterogeneity in methodological approaches, including reported use of randomization, blinding, and DMCs.
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Clinical manifestations of tension pneumothorax: protocol for a systematic review and meta-analysis
2014-01-01
Background Although health care providers utilize classically described signs and symptoms to diagnose tension pneumothorax, available literature sources differ in their descriptions of its clinical manifestations. Moreover, while the clinical manifestations of tension pneumothorax have been suggested to differ among subjects of varying respiratory status, it remains unknown if these differences are supported by clinical evidence. Thus, the primary objective of this study is to systematically describe and contrast the clinical manifestations of tension pneumothorax among patients receiving positive pressure ventilation versus those who are breathing unassisted. Methods/Design We will search electronic bibliographic databases (MEDLINE, PubMed, EMBASE, and the Cochrane Database of Systematic Reviews) and clinical trial registries from their first available date as well as personal files, identified review articles, and included article bibliographies. Two investigators will independently screen identified article titles and abstracts and select observational (cohort, case–control, and cross-sectional) studies and case reports and series that report original data on clinical manifestations of tension pneumothorax. These investigators will also independently assess risk of bias and extract data. Identified data on the clinical manifestations of tension pneumothorax will be stratified according to whether adult or pediatric study patients were receiving positive pressure ventilation or were breathing unassisted, as well as whether the two investigators independently agreed that the clinical condition of the study patient(s) aligned with a previously published tension pneumothorax working definition. These data will then be summarized using a formal narrative synthesis alongside a meta-analysis of observational studies and then case reports and series where possible. Pooled or combined estimates of the occurrence rate of clinical manifestations will be calculated using random effects models (for observational studies) and generalized estimating equations adjusted for reported potential confounding factors (for case reports and series). Discussion This study will compile the world literature on tension pneumothorax and provide the first systematic description of the clinical manifestations of the disorder according to presenting patient respiratory status. It will also demonstrate a series of methods that may be used to address difficulties likely to be encountered during the conduct of a meta-analysis of data contained in published case reports and series. PROSPERO registration number: CRD42013005826. PMID:24387082
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Al Muderis, Munjed M; Lu, William Y; Li, Jiao Jiao; Kaufman, Kenton; Orendurff, Michael; Highsmith, M Jason; Lunseth, Paul A; Kahle, Jason T
2018-02-01
The current standard of care for an amputee is a socket-based prostheses. An osseointegrated implant (OI) is an alternative for prosthetic attachment. Osseointegration addresses reported problems related to wearing a socket interface, such as skin issues, discomfort, diminished function, quality of life, prosthetic use, and abandonment. The purpose of this report is to systematically review current literature regarding OI to identify and categorize the reported clinically relevant outcome measures, rate the quality of available evidence, and synthesize the findings. A multidisciplinary team used PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methods. Search methodology was based on identifying clinically relevant articles. Three databases were searched: PubMed, CINAHL, and Web of Science. Clinical studies with aggregated data reporting at least 1 clinically relevant outcome measure were included. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criterion was used for critical appraisal and recommendations. This review identified 21 clinically relevant observational studies. Outcome measures were categorized into the following 9 categories: vibratory stimulation, complications, biomechanics, economics, patient-reported outcome measures, electromyography, x-ray, physical functional performance, and energy consumption. This systematic review consisted of Level III and IV observational studies. Homogeneous outcome measures with strong psychometric properties across prospective studies do not exist to date. Higher-level, prospective, randomized, long-term, clinically relevant trials are needed to prove efficacy of OI compared with socket prosthetic attachment. Osseointegration was at least equivalent to sockets in most studies. In some cases, it was superior. Osseointegration represents a promising alternative to socket prosthetic attachments for extremity amputees. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
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Chuang, Sheuwen; Howley, Peter P; Hancock, Stephen
2013-07-01
The aim of the study was to determine accreditation surveyors' and hospitals' use and perceived usefulness of clinical indicator reports and the potential to establish the control relationship between the accreditation and reporting systems. The control relationship refers to instructional directives, arising from appropriately designed methods and efforts towards using clinical indicators, which provide a directed moderating, balancing and best outcome for the connected systems. Web-based questionnaire survey. Australian Council on Healthcare Standards' (ACHS) accreditation and clinical indicator programmes. Seventy-three of 306 surveyors responded. Half used the reports always/most of the time. Five key messages were revealed: (i) report use was related to availability before on-site investigation; (ii) report use was associated with the use of non-ACHS reports; (iii) a clinical indicator set's perceived usefulness was associated with its reporting volume across hospitals; (iv) simpler measures and visual summaries in reports were rated the most useful; (v) reports were deemed to be suitable for the quality and safety objectives of the key groups of interested parties (hospitals' senior executive and management officers, clinicians, quality managers and surveyors). Implementing the control relationship between the reporting and accreditation systems is a promising expectation. Redesigning processes to ensure reports are available in pre-survey packages and refined education of surveyors and hospitals on how to better utilize the reports will support the relationship. Additional studies on the systems' theory-based model of the accreditation and reporting system are warranted to establish the control relationship, building integrated system-wide relationships with sustainable and improved outcomes.
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Media Reporting of Practice-Changing Clinical Trials in Oncology: A North American Perspective.
Andrew, Peter; Vickers, Michael M; O'Connor, Stephen; Valdes, Mario; Tang, Patricia A
2016-03-01
Media reporting of clinical trials impacts patient-oncologist interactions. We sought to characterize the accuracy of media and Internet reporting of practice-changing clinical trials in oncology. The first media articles referencing 17 practice-changing clinical trials were collected from 4 media outlets: newspapers, cable news, cancer websites, and industry websites. Measured outcomes were media reporting score, social media score, and academic citation score. The media reporting score was a measure of completeness of information detailed in media articles as scored by a 15-point scoring instrument. The social media score represented the ubiquity of social media presence referencing 17 practice-changing clinical trials in cancer as determined by the American Society of Clinical Oncology in its annual report, entitled Clinical Cancer Advances 2012; social media score was calculated from Twitter, Facebook, and Google searches. The academic citation score comprised total citations from Google Scholar plus the Scopus database, which represented the academic impact per clinical cancer advance. From 170 media articles, 107 (63%) had sufficient data for analysis. Cohen's κ coefficient demonstrated reliability of the media reporting score instrument with a coefficient of determination of 94%. Per the media reporting score, information was most complete from industry, followed by cancer websites, newspapers, and cable news. The most commonly omitted items, in descending order, were study limitations, exclusion criteria, conflict of interest, and other. The social media score was weakly correlated with academic citation score. Media outlets appear to have set a low bar for coverage of many practice-changing advances in oncology, with reports of scientific breakthroughs often omitting basic study facts and cautions, which may mislead the public. The media should be encouraged to use a standardized reporting template and provide accessible references to original source information whenever feasible. ©AlphaMed Press.
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Minimum reporting standards for clinical research on groin pain in athletes
Delahunt, Eamonn; Thorborg, Kristian; Khan, Karim M; Robinson, Philip; Hölmich, Per; Weir, Adam
2015-01-01
Groin pain in athletes is a priority area for sports physiotherapy and sports medicine research. Heterogeneous studies with low methodological quality dominate research related to groin pain in athletes. Low-quality studies undermine the external validity of research findings and limit the ability to generalise findings to the target patient population. Minimum reporting standards for research on groin pain in athletes are overdue. We propose a set of minimum reporting standards based on best available evidence to be utilised in future research on groin pain in athletes. Minimum reporting standards are provided in relation to: (1) study methodology, (2) study participants and injury history, (3) clinical examination, (4) clinical assessment and (5) radiology. Adherence to these minimum reporting standards will strengthen the quality and transparency of research conducted on groin pain in athletes. This will allow an easier comparison of outcomes across studies in the future. PMID:26031644
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Chhapola, Viswas; Kanwal, Sandeep Kumar; Brar, Rekha
2015-05-01
To carry out a cross-sectional survey of the medical literature on laboratory research papers published later than 2012 and available in the common search engines (PubMed, Google Scholar) on the quality of statistical reporting of method comparison studies using Bland-Altman (B-A) analysis. Fifty clinical studies were identified which had undertaken method comparison of laboratory analytes using B-A. The reporting of B-A was evaluated using a predesigned checklist with following six items: (1) correct representation of x-axis on B-A plot, (2) representation and correct definition of limits of agreement (LOA), (3) reporting of confidence interval (CI) of LOA, (4) comparison of LOA with a priori defined clinical criteria, (5) evaluation of the pattern of the relationship between difference (y-axis) and average (x-axis) and (6) measures of repeatability. The x-axis and LOA were presented correctly in 94%, comparison with a priori clinical criteria in 74%, CI reporting in 6%, evaluation of pattern in 28% and repeatability assessment in 38% of studies. There is incomplete reporting of B-A in published clinical studies. Despite its simplicity, B-A appears not to be completely understood by researchers, reviewers and editors of journals. There appear to be differences in the reporting of B-A between laboratory medicine journals and other clinical journals. A uniform reporting of B-A method will enhance the generalizability of results. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.
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Simonaitis, Linas; Belsito, Anne; Warvel, Jeff; Hui, Siu; McDonald, Clement J
2006-01-01
Clinicians at Wishard Hospital in Indianapolis print and carry clinical reports called "Pocket Rounds". This paper describes a new process we developed to improve these clinical reports. The heart of our new process is a World Wide Web Consortium standard: Extensible Stylesheet Language Formatting Objects (XSL-FO). Using XSL-FO stylesheets we generated Portable Document Format (PDF) and PostScript reports with complex formatting: columns, tables, borders, shading, indents, dividing lines. We observed patterns of clinical report printing during a eight month study period on three Medicine wards. Usage statistics indicated that clinicians accepted the new system enthusiastically: 78% of 26,418 reports were printed using the new system. We surveyed 67 clinical users. Respondents gave the new reports a rating of 4.2 (on a 5 point scale); they gave the old reports a rating of 3.4. The primary complaint was that it took longer to print the new reports. We believe that XSL-FO is a promising way to transform text data into functional and attractive clinical reports: relatively easy to implement and modify.
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Hartung, Daniel M; Zarin, Deborah A; Guise, Jeanne-Marie; McDonagh, Marian; Paynter, Robin; Helfand, Mark
2014-04-01
ClinicalTrials.gov requires reporting of result summaries for many drug and device trials. To evaluate the consistency of reporting of trials that are registered in the ClinicalTrials.gov results database and published in the literature. ClinicalTrials.gov results database and matched publications identified through ClinicalTrials.gov and a manual search of 2 electronic databases. 10% random sample of phase 3 or 4 trials with results in the ClinicalTrials.gov results database, completed before 1 January 2009, with 2 or more groups. One reviewer extracted data about trial design and results from the results database and matching publications. A subsample was independently verified. Of 110 trials with results, most were industry-sponsored, parallel-design drug studies. The most common inconsistency was the number of secondary outcome measures reported (80%). Sixteen trials (15%) reported the primary outcome description inconsistently, and 22 (20%) reported the primary outcome value inconsistently. Thirty-eight trials inconsistently reported the number of individuals with a serious adverse event (SAE); of these, 33 (87%) reported more SAEs in ClinicalTrials.gov. Among the 84 trials that reported SAEs in ClinicalTrials.gov, 11 publications did not mention SAEs, 5 reported them as zero or not occurring, and 21 reported a different number of SAEs. Among 29 trials that reported deaths in ClinicalTrials.gov, 28% differed from the matched publication. Small sample that included earliest results posted to the database. Reporting discrepancies between the ClinicalTrials.gov results database and matching publications are common. Which source contains the more accurate account of results is unclear, although ClinicalTrials.gov may provide a more comprehensive description of adverse events than the publication. Agency for Healthcare Research and Quality.
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Nembhard, Ingrid M.; Yuan, Christina T.; Shabanova, Veronika; Cleary, Paul D.
2017-01-01
Background Aspects of the patient care experience, despite being central to quality care, are often problematic. In particular, patients frequently report problems with timeliness of care. As yet, research offers little insight on setting characteristics that contribute to patients’ experience of timely care. Purpose The aims of this study were to assess the relationship between organizational climate and patients’ reports of timely care in primary care clinics and to broadly examine the link between staff’s work environment and patient care experiences. We test hypotheses about the relationship between voice climate—staff feeling safe to speak up about issues—and reported timeliness of care, consistency in reported voice climate across professions, and how climate differences for various professions relate to timely care. Methodology We conducted a cross-sectional study of employees (n = 1,121) and patients (n = 8,164) affiliated with 37 clinics participating in a statewide reporting initiative. Employees were surveyed about clinics’ voice climate, and patients were surveyed about the timeliness of care. Hypotheses were tested using analysis of variance and generalized estimating equations. Findings Clinical and administrative staff (e.g., nurses and office assistants) reported clinics’ climates to be significantly less supportive of voice than did clinical leaders (e.g., physicians). The greater the difference in reported support for voice between professional groups, the less patients reported experiencing timely care in three respects: obtaining an appointment, seeing the doctor within 15 minutes of appointment time, and receiving test results. In clinics where staff reported climates supportive of voice, patients indicated receiving more timely care. Clinical leaders’ reports of voice climate had no relationship to reported timeliness of care. Practical Implications Our findings suggest the importance of clinics developing a strong climate for voice, particularly for clinical and administrative staff, to support better service quality for patients. PMID:24589927
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Fermaglich, Lewis J; Chen, Ru; Kim, Carol Y; Chuh, Eunjung Esther; Thomas, Teena; Shetty, Daiva; Lee, Julia; Young, Johnny; Fan, Ying
2018-01-01
The objective of this report is to summarize common deficiencies identified in the filing reviews of abbreviated new drug applications (ANDAs) with clinical endpoint bioequivalence studies and skin irritation, sensitization, and adhesion (I/S/A) studies received by the US Food and Drug Administration (FDA) between 2007 and 2017, to help applicants avoid common deficiencies, minimize "refuse-to-receive" (RTR) actions, "information requests," and ANDA approval delays. Multiple internal FDA databases were searched to evaluate and summarize common deficiencies identified in ANDA submissions containing clinical endpoint studies and skin I/S/A studies that required review by the Division of Clinical Review. A total of 275 ANDA submissions with filing reviews from January 2007 to June 2017 were analyzed in this report. Two hundred eighteen (79.3%) filing reviews contained one or more deficiencies. Seventy-nine (28.7%) ANDAs were issued RTR letters because of major clinical deficiencies, specifically bioequivalence and clinical deficiencies, accounting for 9% of overall identified deficiencies. Twenty-two other categories of deficiencies are summarized into 4 main categories: missing information related to the clinical studies other than data sets (38%), missing data sets (35%), formulation issues (12%), and organization/format issues (6%). The most common deficiency in the "missing information related to the clinical studies other than data sets" category was "missing clarification of information" (22%). We also noted that the Division of Filing Review has identified these same types of deficiencies since assuming responsibility of the filing assessment for ANDAs with clinical endpoint BE studies and skin I/S/A studies. In conclusion, to minimize "refuse-to-receive" actions, "information requests," and approval of ANDA delays for generic drug products, applicants should submit full clinical study reports, including all data sets for drug products recommending clinical studies.
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Comer, C; Smith, T O; Drew, B; Raja, R; Kingsbury, S R; Conaghan, Philip G
2018-03-01
To systematically review the evidence to determine the clinical outcomes and the important methodological quality features of interventional studies on adults with non-inflammatory multi-joint pain (MJP). Systematic search of published and unpublished literature using the databases: AMED, CINAHL, MEDLINE, EMBASE, psycINFO, SPORTDiscus, PEDro, OpenGrey, the EU Clinical Trials Register, World Health Organization International Clinical Trial Registry Platform, ClinicalTrials.gov and the ISRCTN registry (search: inception to 19th October 2017). All papers reporting the clinical outcomes of non-pharmacological interventions for people with non-inflammatory MJP were included. Studies were critically appraised using the Downs and Black Critical Appraisal and the TIDieR reporting checklists. Data were analysed using a Best Evidence Synthesis approach. From 3824 citations, four papers satisfied the eligibility criteria. Three studies reported outcomes from multidisciplinary rehabilitation programmes and one study reported the findings of a spa therapy intervention. All interventions significantly improved pain, function and quality of life in the short-term. There was limited reporting of measures for absenteeism, presenteeism and psychosocial outcomes. The evidence was 'weak', and due to a lack of controlled trials, there is limited evidence to ascertain treatment effectiveness. Design consideration for future trials surround improved reporting of participant characteristics, interventions and the standardisation of core outcome measures. There is insufficient high-quality trial data to determine the effectiveness of treatments for non-inflammatory MJP. Given the significant health burden which this condition presents on both individuals and wider society, developing and testing interventions and accurately reporting these, should be a research priority. Registration PROSPERO (CRD42013005888).
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Variation of clinical outcomes used in glaucoma randomised controlled trials: a systematic review.
Ismail, Rehab; Azuara-Blanco, Augusto; Ramsay, Craig R
2014-04-01
In randomised clinical trials (RCTs) the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. The purpose of this review is to identify different clinical outcomes reported in glaucoma trials. We conducted a systematic review of glaucoma RCTs. A sample or selection of glaucoma trials were included bounded by a time frame (between 2006 and March 2012). Only studies in English language were considered. All clinical measured and reported outcomes were included. The possible variations of clinical outcomes were defined prior to data analysis. Information on reported clinical outcomes was tabulated and analysed using descriptive statistics. Other data recorded included type of intervention and glaucoma, duration of the study, defined primary outcomes, and outcomes used for sample size calculation, if nominated. The search strategy identified 4323 potentially relevant abstracts. There were 315 publications retrieved, of which 233 RCTs were included. A total of 967 clinical measures were reported. There were large variations in the definitions used to describe different outcomes and their measures. Intraocular pressure was the most commonly reported outcome (used in 201 RCTs, 86%) with a total of 422 measures (44%). Safety outcomes were commonly reported in 145 RCTs (62%) whereas visual field outcomes were used in 38 RCTs (16%). There is a large variation in the reporting of clinical outcomes in glaucoma RCTs. This lack of standardisation may impair the ability to evaluate the evidence of glaucoma interventions.
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Factors associated with reporting results for pulmonary clinical trials in ClinicalTrials.gov.
Riley, Isaretta L; Boulware, L Ebony; Sun, Jie-Lena; Chiswell, Karen; Que, Loretta G; Kraft, Monica; Todd, Jamie L; Palmer, Scott M; Anderson, Monique L
2018-02-01
Background/aims The Food and Drug Administration Amendments Act mandates that applicable clinical trials report basic summary results to the ClinicalTrials.gov database within 1 year of trial completion or termination. We aimed to determine the proportion of pulmonary trials reporting basic summary results to ClinicalTrials.gov and assess factors associated with reporting. Methods We identified pulmonary clinical trials subject to the Food and Drug Administration Amendments Act (called highly likely applicable clinical trials) that were completed or terminated between 2008 and 2012 and reported results by September 2013. We estimated the cumulative percentage of applicable clinical trials reporting results by pulmonary disease category. Multivariable Cox regression modeling identified characteristics independently associated with results reporting. Results Of 1450 pulmonary highly likely applicable clinical trials, 380 (26%) examined respiratory neoplasms, 238 (16%) asthma, 175 (12%) chronic obstructive pulmonary disease, and 657 (45%) other respiratory diseases. Most (75%) were pharmaceutical highly likely applicable clinical trials and 71% were industry-funded. Approximately 15% of highly likely applicable clinical trials reported results within 1 year of trial completion, while 55% reported results over the 5-year study period. Earlier phase highly likely applicable clinical trials were less likely to report results compared to phase 4 highly likely applicable clinical trials (phases 1/2 and 2 (adjusted hazard ratio 0.41 (95% confidence interval: 0.31-0.54)), phases 2/3 and 3 (adjusted hazard ratio 0.55 (95% confidence interval: 0.42-0.72)) and phase not applicable (adjusted hazard ratio 0.43 (95% confidence interval: 0.29-0.63)). Pulmonary highly likely applicable clinical trials without Food and Drug Administration oversight were less likely to report results compared with those with oversight (adjusted hazard ratio 0.65 (95% confidence interval: 0.51-0.83)). Conclusion A total of 15% of pulmonary clinical highly likely applicable clinical trials report basic summary results to ClinicalTrials.gov within 1 year of trial completion. Strategies to improve reporting are needed within the pulmonary community.
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Matsumura, Yasushi; Hattori, Atsushi; Manabe, Shiro; Takahashi, Daiyo; Yamamoto, Yuichiro; Murata, Taizo; Nakagawa, Akito; Mihara, Naoki; Takeda, Toshihiro
2017-01-01
To improve the efficiency of clinical research, we developed a system to integrate electronic medical records (EMRs) and the electronic data capture system (EDC). EDC is divided into case report form (CRF) reporter and CDMS with CRF receiver with data communication using the operational data model (ODM). The CRF reporter is incorporated into the EMR to share data witth the EMR. In the data transcription type, doctors enter data using a progress note template, which are transmitted to the reporter template. It then generates the ODM. In the direct record type, reporter templates open from the progress note and generate narrative text to make record in the progress note. The configuration files for a study are delivered from the contents server to minimize the setup. This system has been used for 15 clinical studies including 3 clinical trials. This system can save labor and financial costs in clinical research.
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Pagano, Giovanni; Aiello Talamanca, Annarita; Castello, Giuseppe; Cordero, Mario D.; d’Ischia, Marco; Gadaleta, Maria Nicola; Pallardó, Federico V.; Petrović, Sandra; Tiano, Luca; Zatterale, Adriana
2014-01-01
An extensive number of pathologies are associated with mitochondrial dysfunction (MDF) and oxidative stress (OS). Thus, mitochondrial cofactors termed “mitochondrial nutrients” (MN), such as α-lipoic acid (ALA), Coenzyme Q10 (CoQ10), and l-carnitine (CARN) (or its derivatives) have been tested in a number of clinical trials, and this review is focused on the use of MN-based clinical trials. The papers reporting on MN-based clinical trials were retrieved in MedLine up to July 2014, and evaluated for the following endpoints: (a) treated diseases; (b) dosages, number of enrolled patients and duration of treatment; (c) trial success for each MN or MN combinations as reported by authors. The reports satisfying the above endpoints included total numbers of trials and frequencies of randomized, controlled studies, i.e., 81 trials testing ALA, 107 reports testing CoQ10, and 74 reports testing CARN, while only 7 reports were retrieved testing double MN associations, while no report was found testing a triple MN combination. A total of 28 reports tested MN associations with “classical” antioxidants, such as antioxidant nutrients or drugs. Combinations of MN showed better outcomes than individual MN, suggesting forthcoming clinical studies. The criteria in study design and monitoring MN-based clinical trials are discussed. PMID:25380523
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Shepshelovich, D; Yelin, D; Gafter-Gvili, A; Goldman, S; Avni, T; Yahav, D
2018-02-15
Discrepancies between ClinicalTrials.gov entries and matching publications were previously described in general medicine. We aimed to evaluate the consistency of reporting in trials addressing systemic antibiotic therapy. We searched ClinicalTrials.gov for completed phase III trials comparing antibiotic regimens until May 2017. Matched publications were identified in PubMed. Two independent reviewers extracted data and identified inconsistencies. Reporting was assessed among studies started before and after 1 July 2005, when the International Committee of Medical Journal Editors (ICMJE) required mandatory registration as a prerequisite for considering a trial for publication. Matching publications were identified for 75 (70%) of 107 ClinicalTrials.gov entries. Median time from study completion to publication was 26 months (interquartile range 19-42). Primary outcome definition was inconsistent between ClinicalTrials.gov and publications in seven trials (7/72, 10%) and reporting of the primary outcome timeframe was inconsistent in 14 (14/71, 20%). Secondary outcomes definitions were inconsistent in 36 trials (36/66, 55%). Reporting of inclusion criteria and study timeline were inconsistent in 17% (13/65) and 3% (2/65), respectively. Trials started after July 2005 were significantly less likely to have reporting inconsistencies and were published in higher impact factor journals. We found a lower inconsistency rate of outcome reporting compared with other medical disciplines. Reporting completeness and consistency were significantly better after July 2005. The ICMJE requirement for mandatory registration was associated with significant improvement in reporting quality in infectious diseases trials. Prolonged time lag to publication and missing data from unpublished trials should raise a discussion on current reporting and publishing procedures. Copyright © 2018 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
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Outcome reporting following navigated high tibial osteotomy of the knee: a systematic review.
Yan, James; Musahl, Volker; Kay, Jeffrey; Khan, Moin; Simunovic, Nicole; Ayeni, Olufemi R
2016-11-01
This systematic review evaluates radiographic and clinical outcome reporting following navigated high tibial osteotomy (HTO). Conventional HTO was used as a control to compare outcomes and furthermore investigate the quality of evidence in studies reporting outcomes for navigated HTO. It was hypothesized that navigated HTO will show superior clinical and radiographic outcomes compared to conventional HTO. Two independent reviewers searched PubMed, Ovid (MEDLINE), EMBASE, and Cochrane databases for studies reporting outcomes following navigated HTO. Titles, abstracts, and full-text were screened in duplicate using an a priori inclusion and exclusion criteria. Descriptive statistics were calculated using Minitab ® statistical software. Methodological Index for Nonrandomized Studies (MINORS) and Cochrane Risk of Bias Scores were used to evaluate methodological quality. Thirty-four studies which involved 2216 HTOs were analysed in this review, 1608 (72.6 %) navigated HTOs and 608 (27.4 %) conventional HTOs. The majority of studies were of level IV evidence (16). Clinical outcomes were reported in knee and function scores or range of motion comparisons. Postoperative clinical and functional scores were improved by navigated HTO although it is not demonstrated if there is significant improvement compared to conventional HTO. Most common clinical outcome score reported was Lysholm scores (6) which report postoperative scores of 87.8 (standard deviation 5.9) and 88.8 (standard deviation 5.9) for conventional and navigation-assisted HTO, respectively. Radiographic outcomes reported commonly were weight-bearing mechanical axis, coronal plane angle, and posterior tibial slope angle in the sagittal plane. Studies have shown HTO gives significant correction of mechanical alignment and navigated HTO produces significantly less change in posterior tibial slope postoperatively compared to conventional. The mean MINORS for the 17 non-comparative studies was 9/16, and 15/24 for the 14 non-randomized comparative studies. Navigation HTO results in improved mechanical axis alignment and demonstrates significantly better control over the tibial slope angle change postoperatively compared to conventional methods; however, these improvements have not yet been reflected in clinical outcome scores. Overall the studies report HTO does create significantly improved knee scores and functions compared to patients' preoperative ratings regardless of technique. Future studies on HTO outcomes need to focus on consistency of outcome reporting. IV.
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Global estimate of the incidence of clinical pneumonia among children under five years of age.
Rudan, Igor; Tomaskovic, Lana; Boschi-Pinto, Cynthia; Campbell, Harry
2004-01-01
OBJECTIVE: Clinical pneumonia (defined as respiratory infections associated with clinical signs of pneumonia, principally pneumonia and bronchiolitis) in children under five years of age is still the leading cause of childhood mortality in the world. In this paper we aim to estimate the worldwide incidence of clinical pneumonia in young children. METHODS: Our estimate for the developing world is based on an analysis of published data on the incidence of clinical pneumonia from community based longitudinal studies. Among more than 2000 studies published since 1961, we identified 46 studies that reported the incidence of clinical pneumonia, and 28 of these met pre-defined quality criteria. FINDINGS: The estimate of the median incidence from those studies was 0.28 episodes per child-year (e/cy). The 25-75% interquartile range was 0.21-0.71. We assessed the plausibility of this estimate using estimates of global mortality from acute respiratory infections and reported case fatality rates for all episodes of clinical pneumonia reported in community-based studies or the case-fatality rate reported only for severe cases and estimates of the proportion of severe cases occurring in a defined population or community. CONCLUSION: The overlap between the ranges of the estimates implies that a plausible incidence estimate of clinical pneumonia for developing countries is 0.29 e/cy. This equates to an annual incidence of 150.7 million new cases, 11-20 million (7-13%) of which are severe enough to require hospital admission. In the developed world no comparable data are available. However, large population-based studies report that the incidence of community-acquired pneumonia among children less than five years old is approximately 0.026 e/cy, suggesting that more than 95% of all episodes of clinical pneumonia in young children worldwide occur in developing countries. PMID:15654403
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Gromann, P M; Goossens, F A; Olthof, T; Pronk, J; Krabbendam, L
2013-04-01
Bullying victimization may be linked to psychosis but only self-report measures of victimization have been used so far. This study aimed (a) to investigate the differential associations of peer-nominated versus self-reported victim status with non-clinical psychotic experiences in a sample of young adolescents, and (b) to examine whether different types of self-reported victimization predict non-clinical psychotic experiences in these adolescents. Method A combination of standard self-report and peer nomination procedures was used to assess victimization. The sample (n = 724) was divided into four groups (exclusively self-reported victims, self- and peer-reported victims, exclusively peer-reported victims, and non-victims) to test for a group effect on non-clinical psychotic experiences. The relationship between types of victimization and non-clinical psychotic experiences was examined by a regression analysis. Self-reported victims, along with self- and peer-reported victims, scored higher than peer-reported victims and non-victims on non-clinical psychotic experiences. Self-reports of direct relational, indirect relational and physical victimization significantly improved the prediction of non-clinical psychotic experiences whereas verbal and possession-directed victimization had no significant predictive value. The relationship between victimization and non-clinical psychotic experiences is only present for self-reported victimization, possibly indicative of an interpretation bias. The observed discrepancy between self-report and peer-report highlights the importance of implementing a combination of both measures for future research.
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Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.
Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M
2015-01-01
In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.
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Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey
Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M
2015-01-01
Background In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA’s pre-market approval (PMA) pathway. Methods and results We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. PMID:26060416
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Ramsey, Scott D; Willke, Richard J; Glick, Henry; Reed, Shelby D; Augustovski, Federico; Jonsson, Bengt; Briggs, Andrew; Sullivan, Sean D
2015-03-01
Clinical trials evaluating medicines, medical devices, and procedures now commonly assess the economic value of these interventions. The growing number of prospective clinical/economic trials reflects both widespread interest in economic information for new technologies and the regulatory and reimbursement requirements of many countries that now consider evidence of economic value along with clinical efficacy. As decision makers increasingly demand evidence of economic value for health care interventions, conducting high-quality economic analyses alongside clinical studies is desirable because they broaden the scope of information available on a particular intervention, and can efficiently provide timely information with high internal and, when designed and analyzed properly, reasonable external validity. In 2005, ISPOR published the Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials: The ISPOR RCT-CEA Task Force report. ISPOR initiated an update of the report in 2014 to include the methodological developments over the last 9 years. This report provides updated recommendations reflecting advances in several areas related to trial design, selecting data elements, database design and management, analysis, and reporting of results. Task force members note that trials should be designed to evaluate effectiveness (rather than efficacy) when possible, should include clinical outcome measures, and should obtain health resource use and health state utilities directly from study subjects. Collection of economic data should be fully integrated into the study. An incremental analysis should be conducted with an intention-to-treat approach, complemented by relevant subgroup analyses. Uncertainty should be characterized. Articles should adhere to established standards for reporting results of cost-effectiveness analyses. Economic studies alongside trials are complementary to other evaluations (e.g., modeling studies) as information for decision makers who consider evidence of economic value along with clinical efficacy when making resource allocation decisions. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
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Huser, Vojtech; Sastry, Chandan; Breymaier, Matthew; Idriss, Asma; Cimino, James J
2015-10-01
Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM's initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements. Using a case study approach, we evaluated ODM's ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard. Published by Elsevier Inc.
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Ghebre, Rahel G; Jones, Lovell A; Wenzel, Jennifer A; Martin, Michelle Y; Durant, Raegan W; Ford, Jean G
2014-04-01
Patient navigation programs are emerging that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process as well as outcome measures to evaluate program effectiveness. A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. The eligible studies reported on the development of programs for patient navigation in cancer clinical trials, including training and implementation among African Americans, American Indians, and Native Hawaiians. A low rate of clinical trial refusal (range, 4%-6%) was reported among patients enrolled in patient navigation programs. However, few studies reported on the efficacy of patient navigation in increasing clinical treatment trial enrollment. Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. © 2014 American Cancer Society.
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Ghebre, Rahel G.; Jones, Lovell A.; Wenzel, Jennifer; Martin, Michelle Y.; Durant, Raegan; Ford, Jean G.
2014-01-01
Background Patient navigation programs are emerging, that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process, as well as outcome measures to evaluate program effectiveness. Methods A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. Results The eligible studies reported on development of programs for patient navigation in cancer clinical trials, including training and implementation among African American, American Indian and Native Hawaiians. Low clinical trial refusal, 4% to 6%, was reported among patients enrolled in patient navigation program. However, few studies reported on the efficacy of patient navigation on increasing clinical treatment trial enrollment. Conclusion Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. PMID:24643650
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2016-10-01
and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation. REPORT...Applicability: Well- designed CAT-PRO questionnaires can be used in both clinical trials and day-to-day clinical practice. For clinical trials, they provide...confirm that items are responsive to self-reported changes in milestone ability over a time period consistent with design of contemporary clinical
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Boric acid for recurrent vulvovaginal candidiasis: the clinical evidence.
Iavazzo, Christos; Gkegkes, Ioannis D; Zarkada, Ioanna M; Falagas, Matthew E
2011-08-01
Recurrent vulvovaginal candidiasis (VVC) remains a challenge to manage in clinical practice. Recent epidemiologic studies indicate that non-albicans Candida spp. are more resistant to conventional antifungal treatment with azoles and are considered as causative pathogens of vulvovaginal candidiasis. We searched PubMed and Scopus for studies that reported clinical evidence on the intravaginal use of boric acid for vulvovaginal candidiasis. We identified 14 studies (2 randomized clinical trials [RCTs], 9 case series, and 4 case reports) as eligible for inclusion in this review. Boric acid was compared with nystatin, terconazole, flucytosine, itraconazole, clotrimazole, ketoconazole, fluconazole, buconazole, and miconazole; as monotherapy, boric acid was studied in 7 studies. The mycologic cure rates varied from 40% to 100% in patients treated with boric acid; 4 of the 9 included case series reported statistically significant outcomes regarding cure (both mycologic and clinical) rates. None of the included studies reported statistically significant differences in recurrence rates. Regarding the adverse effects caused by boric acid use, vaginal burning sensation (<10% of cases), water discharge during treatment, and vaginal erythema were identified in 7 studies. Our findings suggest that boric acid is a safe, alternative, economic option for women with recurrent and chronic symptoms of vaginitis when conventional treatment fails because of the involvement of non-albicans Candida spp. or azole-resistant strains.
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Feasibility of Conducting Autism Biomarker Research in the Clinical Setting.
Sices, Laura; Pawlowski, Katherine; Farfel, Laura; Phillips, Deirdre; Howe, Yamini; Cochran, David M; Choueiri, Roula; Forbes, Peter W; Brewster, Stephanie J; Frazier, Jean A; Neumeyer, Ann; Bridgemohan, Carolyn
2017-09-01
Recruitment and completion of research activities during regular clinical care has the potential to increase research participation in complex neurodevelopmental disorders. We evaluated the feasibility, and effect on clinical care, of conducting biomarker research within a subspecialty clinical visit for autism spectrum disorder (ASD). Children, aged 5 to 10 years, were recruited by providers in ASD clinics at 5 institutions. Biomarkers collected were growth measurements, head circumference, neurologic and dysmorphology examinations, digit ratio (2D:4D) measurement, and platelet serotonin and urinary melatonin sulfate excretion levels. Parents completed the Aberrant Behavior Checklist-Community and a medical/demographic questionnaire. Cognitive level was abstracted from the medical record. Parents and clinicians completed surveys on the effect of the study on the clinical visit. Eighty-three children and their caregivers participated. Factors limiting participation included difficulty reaching families by phone and parent concern about the study blood draw requirement. All children completed at least 4 of 7 planned research activities. Demographic factors, educational placement, and child behavior were not associated with completion of study activities. Lower nonverbal cognitive function was weakly associated with fewer activities completed. Forty-four percent of clinicians reported an effect of the research study on the clinical visit. However, neither parent-reported nor clinician-reported effect was associated with the degree of study activity completion. Recruiting study participants in the context of scheduled ASD clinical visits required significant effort. However, once recruited, participants completed most study activities, regardless of behavioral symptom severity. Research activities did not adversely affect the clinical visit.
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Alfonso, Jorge Emilio; Berlana, David; Ukleja, Andrew; Boullata, Joseph
2017-09-01
Multichamber bags (MCBs) may offer potential clinical, ergonomic, and economic advantages compared with (hospital) pharmacy compounded bags (COBs) and multibottle systems (MBSs). A systematic literature review was performed to identify and assess the available evidence regarding advantages of MCBs compared with COBs and MBSs. Medline, Embase, the Cochrane Databases, and EconLit were searched for articles reporting clinical, ergonomic, and economic outcomes for MCBs compared with COBs or MBSs. The search was limited to studies conducted in hospitalized patients >2 years of age that were published in English between January 1990 and November 2014. The Population Intervention Comparison Outcomes Study Design (PICOS) framework was used for the analysis. From 1307 unique citations, 74 potentially relevant publications were identified; review of references identified 2 additional publications. Among the 76 publications, 18 published studies met the inclusion criteria. Most were retrospective in design. Ten studies reported clinical outcomes, including 1 prospective randomized trial and multiple retrospective analyses that reported a lower risk of bloodstream infection for MCBs compared with other delivery systems. Sixteen studies reported ergonomic and/or economic outcomes; most reported a potential cost benefit for MCBs, with consistent reports of reduced time and labor compared with other systems. The largest cost benefit was observed in studies evaluating total hospitalization costs. The systematic literature review identified evidence of potential clinical, ergonomic, and economic benefits for MCBs compared with COBs and MBSs; however, methodological factors limited evidence quality. More prospective studies are required to corroborate existing evidence.
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Kunimitsu, Ayano
2009-01-01
Background The accuracy of malaria case reporting is challenging due to restricted human and material resources in many countries. The reporting often depends on the clinical diagnosis because of the scarcity of microscopic examinations. Particularly, clinical malaria case reporting by primary health care facilities (local clinics), which constitutes the baseline data of surveillance, has never previously been sufficiently evaluated. In order to improve the malaria reporting system to the level required to eventually eliminate this disease, this study estimates the gaps between the records of clinics and government statistics regarding the incidence of clinical malaria, and then also examines some factors that might explain the data discrepancy, including such variables as clinic staffing and record keeping. Methods All medical records for outpatients in 2007, handwritten by nurses, were collected from local clinics in Honiara, the capital of the Solomon Islands. The all-monthly clinical malaria cases were then recalculated. The corresponding monthly data in official statistics were provided by the government. Next, in order to estimate any data discrepancy, the ratio of the cases recorded at clinics to the cases reported to the government was determined on the monthly basis. Finally, the associations between the monthly discrepancy and other variables were evaluated by a multiple regression analysis. Results The mean data discrepancy between the records of clinics and government statistics was 21.2% (n = 96). Significant associations were observed between the discrepancy and the average number of patients (coefficient: 0.05, 95%CI: 0.31, 0.07), illegible handwriting (coefficient: 0.09, 95%CI: 0.04, 0.15), the use of tally sheets (coefficient:-0.38, 95%CI: -0.54, -0.22), and the clinic level (coefficient:-0.48, 95%CI:-0.89,-0.06). Conclusion The findings of this study demonstrate the huge data discrepancy between the records of clinics and government statistics in regard to clinical malaria case reporting. Moreover, the high numbers of patients, illegible writing, the disuse of tally sheets, and insufficient resources at some clinics are likely to be related to the increase in the discrepancy. The clinical malaria case reporting at the local clinic level therefore urgently needs improvement, in order to achieve both better malaria surveillance and to also eventually eliminate this disease in the Solomon Islands. PMID:19389239
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Hansen, Hanne Hoff; Hasselgård, Cecilie Edh; Undheim, Anne Mari; Indredavik, Marit Sæbø
2014-07-01
Few studies have focused the association between bullying and psychiatric disorders in clinical samples. The aim of this study was to examine if bullying behaviour was associated with psychiatric disorders and school well-being. The cross-sectional study was part of a health survey at St. Olav's University Hospital. The sample consisted of 685 adolescent patients aged 13-18 years who completed an electronic questionnaire. Clinical diagnoses were collected from clinical records. In this clinical psychiatric sample, 19% reported being bullied often or very often, and 51% reported being bullied from time to time. Logistic regression analyses showed associations between being a victim and having a mood disorder, and between being involved in bullying behaviour and reporting lower scores on school well-being. No difference was found in bullying behaviour on gender, age and SES. The risk of being a victim was high among adolescents in this clinical sample, especially among patients with mood disorders. Any involvement in bullying behaviour was associated with reduced school well-being.
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Dechartres, Agnes; Bond, Elizabeth G; Scheer, Jordan; Riveros, Carolina; Atal, Ignacio; Ravaud, Philippe
2016-11-30
Publication bias and other reporting bias have been well documented for journal articles, but no study has evaluated the nature of results posted at ClinicalTrials.gov. We aimed to assess how many randomized controlled trials (RCTs) with results posted at ClinicalTrials.gov report statistically significant results and whether the proportion of trials with significant results differs when no treatment effect estimate or p-value is posted. We searched ClinicalTrials.gov in June 2015 for all studies with results posted. We included completed RCTs with a superiority hypothesis and considered results for the first primary outcome with results posted. For each trial, we assessed whether a treatment effect estimate and/or p-value was reported at ClinicalTrials.gov and if yes, whether results were statistically significant. If no treatment effect estimate or p-value was reported, we calculated the treatment effect and corresponding p-value using results per arm posted at ClinicalTrials.gov when sufficient data were reported. From the 17,536 studies with results posted at ClinicalTrials.gov, we identified 2823 completed phase 3 or 4 randomized trials with a superiority hypothesis. Of these, 1400 (50%) reported a treatment effect estimate and/or p-value. Results were statistically significant for 844 trials (60%), with a median p-value of 0.01 (Q1-Q3: 0.001-0.26). For the 1423 trials with no treatment effect estimate or p-value posted, we could calculate the treatment effect and corresponding p-value using results reported per arm for 929 (65%). For 494 trials (35%), p-values could not be calculated mainly because of insufficient reporting, censored data, or repeated measurements over time. For the 929 trials we could calculate p-values, we found statistically significant results for 342 (37%), with a median p-value of 0.19 (Q1-Q3: 0.005-0.59). Half of the trials with results posted at ClinicalTrials.gov reported a treatment effect estimate and/or p-value, with significant results for 60% of these. p-values could be calculated from results reported per arm at ClinicalTrials.gov for only 65% of the other trials. The proportion of significant results was much lower for these trials, which suggests a selective posting of treatment effect estimates and/or p-values when results are statistically significant.
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Probiotic and synbiotic safety in infants under two years of age.
van den Nieuwboer, M; Claassen, E; Morelli, L; Guarner, F; Brummer, R J
2014-03-01
In this study, we systematically evaluated safety aspects in clinical trials with probiotics and synbiotics in young infants (0-2 years of age). This study is an update of earlier reports and covers the recent literature from 2008-2013. The safety evaluation is performed along the Common Terminology Clinical Adverse Events (CTCAE) version 4.0 scale, hereby also providing guidance for future studies. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. The results show a deficiency in the precise reporting and classification of adverse events in most studies. Analysis of 57 clinical trials with probiotics and synbiotics in combination with eight follow-up studies indicate that probiotic administration to infants between 0 and 24 months is safe with regard to the evaluated strains in infants with a particular health status or susceptibility. Most adverse events and serious adverse events were considered unrelated to the study product, and there were no major safety concerns. Almost all studies concluded that none of the adverse effects were related to the study product; the study products are generally well tolerated. Finally, inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes, greatly limit the generalizability of conclusions and argue convincingly for obligatory and standardised behaviour on adverse events (CTCAE) reporting in 'food' studies.
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Bruins, Marjan J; Ruijs, Gijs J H M; Wolfhagen, Maurice J H M; Bloembergen, Peter; Aarts, Jos E C M
2011-03-30
Clinicians view the accuracy of test results and the turnaround time as the two most important service aspects of the clinical microbiology laboratory. Because of the time needed for the culturing of infectious agents, final hardcopy culture results will often be available too late to have a significant impact on early antimicrobial therapy decisions, vital in infectious disease management. The clinical microbiologist therefore reports to the clinician clinically relevant preliminary results at any moment during the diagnostic process, mostly by telephone. Telephone reporting is error prone, however. Electronic reporting of culture results instead of reporting on paper may shorten the turnaround time and may ensure correct communication of results. The purpose of this study was to assess the impact of the implementation of electronic reporting of final microbiology results on medical decision making. In a pre- and post-interview study using a semi-structured design we asked medical specialists in our hospital about their use and appreciation of clinical microbiology results reporting before and after the implementation of an electronic reporting system. Electronic reporting was highly appreciated by all interviewed clinicians. Major advantages were reduction of hardcopy handling and the possibility to review results in relation to other patient data. Use and meaning of microbiology reports differ significantly between medical specialties. Most clinicians need preliminary results for therapy decisions quickly. Therefore, after the implementation of electronic reporting, telephone consultation between clinician and microbiologist remained the key means of communication. Overall, electronic reporting increased the workflow efficiency of the medical specialists, but did not have an impact on their decision-making. © 2011 Bruins et al; licensee BioMed Central Ltd.
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Odgaard, Eric C; Fowler, Robert L
2010-06-01
In 2005, the Journal of Consulting and Clinical Psychology (JCCP) became the first American Psychological Association (APA) journal to require statistical measures of clinical significance, plus effect sizes (ESs) and associated confidence intervals (CIs), for primary outcomes (La Greca, 2005). As this represents the single largest editorial effort to improve statistical reporting practices in any APA journal in at least a decade, in this article we investigate the efficacy of that change. All intervention studies published in JCCP in 2003, 2004, 2007, and 2008 were reviewed. Each article was coded for method of clinical significance, type of ES, and type of associated CI, broken down by statistical test (F, t, chi-square, r/R(2), and multivariate modeling). By 2008, clinical significance compliance was 75% (up from 31%), with 94% of studies reporting some measure of ES (reporting improved for individual statistical tests ranging from eta(2) = .05 to .17, with reasonable CIs). Reporting of CIs for ESs also improved, although only to 40%. Also, the vast majority of reported CIs used approximations, which become progressively less accurate for smaller sample sizes and larger ESs (cf. Algina & Kessleman, 2003). Changes are near asymptote for ESs and clinical significance, but CIs lag behind. As CIs for ESs are required for primary outcomes, we show how to compute CIs for the vast majority of ESs reported in JCCP, with an example of how to use CIs for ESs as a method to assess clinical significance.
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The impact of Public Reporting on clinical outcomes: a systematic review and meta-analysis.
Campanella, Paolo; Vukovic, Vladimir; Parente, Paolo; Sulejmani, Adela; Ricciardi, Walter; Specchia, Maria Lucia
2016-07-22
To assess both qualitatively and quantitatively the impact of Public Reporting (PR) on clinical outcomes, we carried out a systematic review of published studies on this topic. Pubmed, Web of Science and SCOPUS databases were searched to identify studies published from 1991 to 2014 that investigated the relationship between PR and clinical outcomes. Studies were considered eligible if they investigated the relationship between PR and clinical outcomes and comprehensively described the PR mechanism and the study design adopted. Among the clinical outcomes identified, meta-analysis was performed for overall mortality rate which quantitative data were exhaustively reported in a sufficient number of studies. Two reviewers conducted all data extraction independently and disagreements were resolved through discussion. The same reviewers evaluated also the quality of the studies using a GRADE approach. Twenty-seven studies were included. Mainly, the effect of PR on clinical outcomes was positive. Meta-analysis regarding overall mortality included, in a context of high heterogeneity, 10 studies with a total of 1,840,401 experimental events and 3,670,446 control events and resulted in a RR of 0.85 (95 % CI, 0.79-0.92). The introduction of PR programs at different levels of the healthcare sector is a challenging but rewarding public health strategy. Existing research covering different clinical outcomes supports the idea that PR could, in fact, stimulate providers to improve healthcare quality.
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de Vries, Annelou L C; Steensma, Thomas D; Cohen-Kettenis, Peggy T; VanderLaan, Doug P; Zucker, Kenneth J
2016-06-01
This study is the third in a series to examine behavioral and emotional problems in children and adolescents with gender dysphoria in a comparative analysis between two clinics in Toronto, Ontario, Canada and Amsterdam, the Netherlands. In the present study, we report Child Behavior Checklist (CBCL) and Youth Self-Report (YSR) data on adolescents assessed in the Toronto clinic (n = 177) and the Amsterdam clinic (n = 139). On the CBCL and the YSR, we found that the percentage of adolescents with clinical range behavioral and emotional problems was higher when compared to the non-referred standardization samples but similar to the referred adolescents. On both the CBCL and the YSR, the Toronto adolescents had a significantly higher Total Problem score than the Amsterdam adolescents. Like our earlier studies of CBCL data of children and Teacher's Report Form data of children and adolescents, a measure of poor peer relations was the strongest predictor of CBCL and YSR behavioral and emotional problems in gender dysphoric adolescents.
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Use of patient-reported outcome measures in foot and ankle research.
Hunt, Kenneth J; Hurwit, Daniel
2013-08-21
In the orthopaedic literature, there is a wide range of clinical outcome measurement tools that have been used in evaluating foot and ankle procedures, disorders, and outcomes, with no broadly accepted consensus as to which tools are preferred. The purpose of this study was to determine the frequency and distribution of the various outcome instruments used in the foot and ankle literature, and to identify trends for use of these instruments over time. We conducted a systematic review of all original clinical articles reporting on foot and/or ankle topics in six orthopaedic journals over a ten-year period (2002 to 2011). All clinical patient-reported outcome rating instruments used in these articles were recorded, as were study date, study design, clinical topic, and level of evidence. A total of 878 clinical foot and ankle articles that used at least one patient-reported outcome measure were identified among 16,513 total articles published during the ten-year period. There were 139 unique clinical outcome scales used, and the five most popular scales (as a percentage of foot/ankle outcome articles) were the American Orthopaedic Foot & Ankle Society (AOFAS) scales (55.9%), visual analog scale (VAS) for pain (22.9%), Short Form-36 (SF-36) Health Survey (13.7%), Foot Function Index (FFI) (5.5%), and American Academy of Orthopaedic Surgeons (AAOS) outcomes instruments (3.3%). The majority of articles described Level-IV studies (70.1%); only 9.4% reported Level-I studies. A considerable variety of outcome measurement tools are used in the foot and ankle clinical literature, with a small proportion used consistently. The AOFAS scales continue to be used at a high rate relative to other scales that have been validated. Data from the present study underscore the need for a paradigm shift toward the use of consistent, valid, and reliable outcome measures for studies of foot and ankle procedures and disorders. It is not clear which existing validated outcome instruments will emerge as widely used and clinically meaningful. These data support the need for a paradigm shift toward the consistent use of valid and reliable outcome measures for foot and ankle clinical research.
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Brunoni, André R; Tadini, Laura; Fregni, Felipe
2010-03-03
There have been many changes in clinical trials methodology since the introduction of lithium and the beginning of the modern era of psychopharmacology in 1949. The nature and importance of these changes have not been fully addressed to date. As methodological flaws in trials can lead to false-negative or false-positive results, the objective of our study was to evaluate the impact of methodological changes in psychopharmacology clinical research over the past 60 years. We performed a systematic review from 1949 to 2009 on MEDLINE and Web of Science electronic databases, and a hand search of high impact journals on studies of seven major drugs (chlorpromazine, clozapine, risperidone, lithium, fluoxetine and lamotrigine). All controlled studies published 100 months after the first trial were included. Ninety-one studies met our inclusion criteria. We analyzed the major changes in abstract reporting, study design, participants' assessment and enrollment, methodology and statistical analysis. Our results showed that the methodology of psychiatric clinical trials changed substantially, with quality gains in abstract reporting, results reporting, and statistical methodology. Recent trials use more informed consent, periods of washout, intention-to-treat approach and parametric tests. Placebo use remains high and unchanged over time. Clinical trial quality of psychopharmacological studies has changed significantly in most of the aspects we analyzed. There was significant improvement in quality reporting and internal validity. These changes have increased study efficiency; however, there is room for improvement in some aspects such as rating scales, diagnostic criteria and better trial reporting. Therefore, despite the advancements observed, there are still several areas that can be improved in psychopharmacology clinical trials.
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Sampayo-Cordero, Miguel; Miguel-Huguet, Bernat; Pardo-Mateos, Almudena; Moltó-Abad, Marc; Muñoz-Delgado, Cecilia; Pérez-López, Jordi
2018-02-01
Case reports might have a prominent role in the rare diseases field, due to the small number of patients affected by one such disease. A previous systematic review regarding the efficacy of laronidase therapy in patients with mucopolysaccharidosis type I (MPS-I) who initiated enzyme replacement therapy (ERT) in adult age has been published. The review included a meta-analysis of 19 clinical studies and the description of eleven case reports. It was of interest to perform a meta-analysis of those case reports to explore the role of such meta-analyses as a tool for evidence-based medicine in rare diseases. The study included all case reports with standard treatment regimen. Primary analysis was the percentage of case reports showing an improvement in a specific outcome. Only when that percentage was statistically higher than 5%, the improvement was confirmed as such. The outcomes that accomplished this criterion were ranked and compared to the GRADE criteria obtained by those same outcomes in the previous meta-analysis of clinical studies. There were three outcomes that had a significant improvement: Urine glycosaminoglycans, liver volume and 6-minute walking test. Positive and negative predictive values, sensitivity and specificity for the results of the meta-analysis of case reports as compared to that of clinical studies were 100%, 88.9%, 75% and 100%, respectively. Accordingly, absolute (Rho=0.82, 95%CI: 0.47 to 0.95) and relative agreement (Kappa=0.79, 95%CI: 0.593 to 0.99) between the number of case reports with improvement in a specific outcome and the GRADE evidence score for that outcome were good. Sensitivity analysis showed that agreement between the meta-analysis of case reports and that of the clinical studies were good only when using a strong confirmatory strategy for outcome improvement in case reports. We found an agreement between the results of meta-analyses from case reports and from clinical studies in the efficacy of laronidase therapy in patients with MPS-I who initiated ERT in adult age. This agreement suggests that combining case reports quantitatively, rather than analyzing them separately or qualitatively, may improve conclusions in the field of rare diseases. Copyright © 2018 Elsevier Inc. All rights reserved.
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Jensen, Roxanne E; Rothrock, Nan E; DeWitt, Esi M; Spiegel, Brennan; Tucker, Carole A; Crane, Heidi M; Forrest, Christopher B; Patrick, Donald L; Fredericksen, Rob; Shulman, Lisa M; Cella, David; Crane, Paul K
2015-02-01
Patient-reported outcomes (PROs) are gaining recognition as key measures for improving the quality of patient care in clinical care settings. Three factors have made the implementation of PROs in clinical care more feasible: increased use of modern measurement methods in PRO design and validation, rapid progression of technology (eg, touchscreen tablets, Internet accessibility, and electronic health records), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations. As electronic PRO collection and reporting capabilities have improved, the challenges of collecting PRO data have changed. To update information on PRO adoption considerations in clinical care, highlighting electronic and technical advances with respect to measure selection, clinical workflow, data infrastructure, and outcomes reporting. Five practical case studies across diverse health care settings and patient populations are used to explore how implementation barriers were addressed to promote the successful integration of PRO collection into the clinical workflow. The case studies address selecting and reporting of relevant content, workflow integration, previsit screening, effective evaluation, and electronic health record integration. These case studies exemplify elements of well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. They also highlight emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems.
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Jensen, Roxanne E.; Rothrock, Nan E.; DeWitt, Esi Morgan; Spiegel, Brennan; Tucker, Carole A.; Crane, Heidi M.; Forrest, Christopher B.; Patrick, Donald L.; Fredericksen, Rob; Shulman, Lisa M.; Cella, David; Crane, Paul K.
2016-01-01
Background Patient-reported outcomes (PROs) are gaining recognition as key measures for improving the quality of patient care in clinical care settings. Three factors have made the implementation of PROs in clinical care more feasible: increased use of modern measurement methods in PRO design and validation, rapid progression of technology (e.g., touch screen tablets, Internet accessibility, and electronic health records (EHRs)), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations. As electronic PRO collection and reporting capabilities have improved, the challenges of collecting PRO data have changed. Objectives To update information on PRO adoption considerations in clinical care, highlighting electronic and technical advances with respect to measure selection, clinical workflow, data infrastructure, and outcomes reporting. Methods Five practical case studies across diverse healthcare settings and patient populations are used to explore how implementation barriers were addressed to promote the successful integration of PRO collection into the clinical workflow. The case studies address selecting and reporting of relevant content, workflow integration, pre-visit screening, effective evaluation, and EHR integration. Conclusions These case studies exemplify elements of well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. They also highlight emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems. PMID:25588135
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The Identification and Assessment of Late-life ADHD in Memory Clinics
Fischer, Barbara L.; Gunter-Hunt, Gail; Steinhafel, Courtney Holm; Howell, Timothy
2013-01-01
INTRODUCTION Little data exists about attention deficit hyperactivity disorder (ADHD) in late life. While evaluating patients’ memory problems, our Memory Clinic staff has periodically identified ADHD in previously undiagnosed adults. We conducted a survey to assess the extent to which other memory clinics view ADHD as a relevant clinical issue. METHOD We developed and sent a questionnaire to Memory Clinics in the United States to ascertain how ADHD was identified and addressed. The percentage of responding memory clinics’ means of assessing and managing late-life ADHD comprised the measurements for this study. RESULTS Approximately one-half of responding memory clinics reported seeing ADHD patients. Of these, one-half reported identifying previously diagnosed cases, and almost one-half reported diagnosing ADHD themselves. One fifth of clinics reported screening regularly for ADHD, and few clinics described treatment methods. CONCLUSION Our results suggest that U.S. memory clinics may not adequately identify and address ADHD in late life. PMID:22173147
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Why mistreatment of medical students is not reported in clinical settings: perspectives of trainees.
Ahmadipour, Habibeh; Vafadar, Reza
2016-01-01
Mistreatment of medical students is a major source of stress for them. Studies indicate a high incidence of such mistreatment, especially in clinical settings. In most cases, students who have been mistreated do not report it to the authorities. This study investigated factors related to the failure to report mistreatment. This was a cross-sectional study carried out in Kerman Medical School, Iran. All students in the internship and clerkship stages, as well as residents, were selected through the census method. Experiences of mistreatment and the reasons for not reporting them were evaluated using a questionnaire. The data were analysed with SPSS 19. Ninety-three per cent of the participants experienced mistreatment, but less than half of them reported it. Residents and interns reported emotional and academic mistreatment, respectively, more than other groups. The most common reason for not reporting mistreatment was that the students did not think reporting would accomplish anything. Our study showed that the experience of mistreatment in the clinical setting is common, but the cases reported to the authorities are far fewer than the actual number of cases. Educational systems should make extensive efforts to detect and prevent mistreatment to improve the teaching-learning environment.
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Chen, Ruijun; Desai, Nihar R; Ross, Joseph S; Zhang, Weiwei; Chau, Katherine H; Wayda, Brian; Murugiah, Karthik; Lu, Daniel Y; Mittal, Amit; Krumholz, Harlan M
2016-02-17
To determine rates of publication and reporting of results within two years for all completed clinical trials registered in ClinicalTrials.gov across leading academic medical centers in the United States. Cross sectional analysis. Academic medical centers in the United States. Academic medical centers with 40 or more completed interventional trials registered on ClinicalTrials.gov. Using the Aggregate Analysis of ClinicalTrials.gov database and manual review, we identified all interventional clinical trials registered on ClinicalTrials.gov with a primary completion date between October 2007 and September 2010 and with a lead investigator affiliated with an academic medical center. The proportion of trials that disseminated results, defined as publication or reporting of results on ClinicalTrials.gov, overall and within 24 months of study completion. We identified 4347 interventional clinical trials across 51 academic medical centers. Among the trials, 1005 (23%) enrolled more than 100 patients, 1216 (28%) were double blind, and 2169 (50%) were phase II through IV. Overall, academic medical centers disseminated results for 2892 (66%) trials, with 1560 (35.9%) achieving this within 24 months of study completion. The proportion of clinical trials with results disseminated within 24 months of study completion ranged from 16.2% (6/37) to 55.3% (57/103) across academic medical centers. The proportion of clinical trials published within 24 months of study completion ranged from 10.8% (4/37) to 40.3% (31/77) across academic medical centers, whereas results reporting on ClinicalTrials.gov ranged from 1.6% (2/122) to 40.7% (72/177). Despite the ethical mandate and expressed values and mission of academic institutions, there is poor performance and noticeable variation in the dissemination of clinical trial results across leading academic medical centers. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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Lang, Niklaus P; Zitzmann, Nicola U
2012-02-01
The articles discussed in working group 3 dealt with specific aspects of clinical research. In this context, the literature reporting on survival and complication rates of implant-supported or implant-tooth supported restorations in longitudinal studies of at least 5 years were discussed. The second aspect dealt with the evaluation of aesthetic outcomes in clinical studies and the related index systems available. Finally, the third aspect discussed dealt with patient-reported outcome measures (PROMs). A detailed appraisal of the available methodology was presented. © 2012 John Wiley & Sons A/S.
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Forman, Robert; Crits-Christoph, Paul; Kaynak, Övgü; Worley, Matt; Hantula, Donald A.; Kulaga, Agatha; Rotrosen, John; Chu, Melissa; Gallop, Robert; Potter, Jennifer; Muchowski, Patrice; Brower, Kirk; Strobbe, Stephen; Magruder, Kathy; Chellis, A’Delle H.; Clodfelter, Tad; Cawley, Margaret
2007-01-01
We report here on the feasibility of implementing a semi-automated performance improvement system - Patient Feedback (PF) - that enables real-time monitoring of patient ratings of therapeutic alliance, treatment satisfaction, and drug/alcohol use in outpatient substance abuse treatment clinics. The study was conducted in 6 clinics within the National Institute on Drug Abuse Clinical Trials Network. It involved a total of thirty-nine clinicians and 6 clinic supervisors. Throughout the course of the study (4 week training period, 4 week baseline, 12 week intervention, 4 week post-intervention assessment, 1 year sustainability phase) there was an overall collection rate of 75.5% of the clinic patient census. In general, the clinicians in these clinics had very positive treatment satisfaction and alliance ratings throughout the study. However, one clinic had worse drug use scores at baseline than other participating clinics, and showed a decrease in self-reported drug use at post-intervention. Although the implementation of the PF system proved to be feasible in actual clinical settings, further modifications of the PF system are needed to enhance any potential clinical usefulness. PMID:17499954
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[Clinical and histopathological features of myositis associated with anti-mitochondrial antibodies].
Shimizu, Jun
2013-01-01
Anti-mitochondrial antibodies (AMA) are known to be characteristic markers of primary biliary cirrhosis (PBC). The association of PBC with myositis has been reported mainly as case reports, and comprehensive studies of the clinical and histopathological features of patients with myositis and AMAs or PBC have not been conducted thus far. We retrospectively reviewed 212 patients with inflammatory myopathies in our laboratory and found 24 patients with AMA-positive myositis (11%) (seven patients with PBC and 17 patients without PBC). The analysis of clinical and histopathological features revealed that myositis associated with AMAs frequently include patients with a clinically chronic disease course, muscle atrophy, cardiopulmonary involvement and granulomatous inflammation, regardless of the presence or absence of PBC. We also reviewed and analyzed the clinical features of previously reported patients. The analysis of 75 patients, which have been described in previous case reports including the ones of meeting abstracts, also showed the similar results about clinical features of myositis associated with AMAs and supported our findings. Our study suggests that myositis associated with AMAs form a characteristic subgroup.
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Self-reported verbal abuse in 1300+ older women within a private, tertiary women's health clinic.
Sood, Richa; Novotny, Paul; Faubion, Stephanie S; Thielen, Jacqueline M; Shuster, Lynne T; Kuhle, Carol L; Kapoor, Ekta; Marnach, Mary; Barrette, Brigitte; Jatoi, Aminah
2016-01-01
Several studies describe "elder abuse" among residents of nursing homes, but this issue is less well studied among independently functioning, community-based women. The current study was undertaken to report rates of self-reported intimate partner violence - with a focus on verbal abuse - among older women within a private tertiary women's health clinic. This study focused on women who completed a questionnaire on domestic abuse. A total of 1389 women with a median age of 55 years (range: 50, 90) are the focus of this report. Most 1102 (79%) were married. Within this group, 100 (7%) women reported verbal abuse within the last year. Rates of physical and sexual abuse were much lower with 9 women (1%) and 2 (<1%), respectively. In univariate analyses, being divorced, being an alcoholic, and having suffered prior abuse were associated with reported verbal abuse. In multivariate analyses, self-reported alcoholism and physical abuse were independently associated with reported verbal abuse. This study found a notable rate of patient-reported verbal abuse in older women within a private, tertiary women's health clinic. This observation should prompt healthcare providers to ask about intimate partner violence - and specifically verbal abuse - regardless of healthcare setting. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
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Hart, Shelley R; Musci, Rashelle J; Ialongo, Nicholas; Ballard, Elizabeth D; Wilcox, Holly C
2013-10-01
Within the context of the recent release of the 2012 National Suicide Prevention Strategy, and as the third leading cause of death for individuals 10- to 24-years-old, suicide prevention is a national priority. A consistently reported and robust risk factor for suicide is a prior suicide attempt; however few studies have investigated the consistency of self-reported lifetime suicide attempts. The goal of this study is to describe the prevalence and characteristics of inconsistent reporting of suicide attempt in a longitudinal cohort of participants annually assessed in 12 waves of data collected from middle school (age 12) to early adulthood (age 22). Among this cohort (n = 678), we compared those who consistently, inconsistently, and never reported a suicide attempt according to demographic and clinical variables. Almost 90% (88.5%) of our sample inconsistently reported a lifetime suicide attempt. Consistent and inconsistent reporters of lifetime suicide attempt did not differ on demographic or clinical variables with the exception of higher rates of lifetime suicidal ideation among consistent reporters (P < .001). Significant clinical differences were evident between inconsistent reporters and nonattempters. Some level of inconsistent reporting of suicide attempt is inevitable when schools or health care systems systematically screen for suicide risk in adolescents. Inconsistent and consistent reporters of suicide attempt differ on few demographic or clinical variables; further prospective research should investigate the reasons for inconsistent reporting as well as the validity and stability of reporting in predicting future suicidal behavior. © 2013 Wiley Periodicals, Inc.
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A systematic scoping review of adherence to reporting guidelines in health care literature
Samaan, Zainab; Mbuagbaw, Lawrence; Kosa, Daisy; Debono, Victoria Borg; Dillenburg, Rejane; Zhang, Shiyuan; Fruci, Vincent; Dennis, Brittany; Bawor, Monica; Thabane, Lehana
2013-01-01
Background Reporting guidelines have been available for the past 17 years since the inception of the Consolidated Standards of Reporting Trials statement in 1996. These guidelines were developed to improve the quality of reporting of studies in medical literature. Despite the widespread availability of these guidelines, the quality of reporting of medical literature remained suboptimal. In this study, we assess the current adherence practice to reporting guidelines; determine key factors associated with better adherence to these guidelines; and provide recommendations to enhance adherence to reporting guidelines for future studies. Methods We undertook a systematic scoping review of systematic reviews of adherence to reporting guidelines across different clinical areas and study designs. We searched four electronic databases (Cumulative Index to Nursing and Allied Health Literature, Web of Science, Embase, and Medline) from January 1996 to September 2012. Studies were included if they addressed adherence to one of the following guidelines: Consolidated Standards of Reporting Trials (CONSORT), Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), Quality of Reporting of Meta-analysis (QUOROM), Transparent Reporting of Evaluations with Nonrandomized Designs (TREND), Meta-analysis Of Observational Studies in Epidemiology (MOOSE) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). A protocol for this study was devised. A literature search, data extraction, and quality assessment were performed independently by two authors in duplicate. This study reporting follows the PRISMA guidelines. Results Our search retrieved 5159 titles, of which 50 were eligible. Overall, 86.0% of studies reported suboptimal levels of adherence to reporting guidelines. Factors associated with better adherence included journal impact factor and endorsement of guidelines, publication date, funding source, multisite studies, pharmacological interventions and larger studies. Conclusion Reporting guidelines in the clinical literature are important to improve the standards of reporting of clinical studies; however, adherence to these guidelines remains suboptimal. Action is therefore needed to enhance the adherence to these standards. Strategies to enhance adherence include journal editorial policies endorsing these guidelines. PMID:23671390
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Brief review of published alprazolam clinical studies
Straw, R. N.
1985-01-01
1 The clinical efficacy of alprazolam has been evaluated in both anxiety states and depressive disorders. In anxiety neurosis, studies have been conducted vs placebo and/or other benzodiazepine tranquilizers. Reports, to date, with regard to panic/phobia disorders have been limited to open-label studies and a single report from a placebo-controlled study. In depression, both open-label and double-blind studies (vs tricyclic antidepressants) have been published. PMID:2859879
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Dissemination of research into clinical nursing literature.
Oermann, Marilyn H; Shaw-Kokot, Julia; Knafl, George J; Dowell, Jo
2010-12-01
The purpose of our study was to describe the dissemination of research into the clinical nursing literature. The literature provides a means of transferring knowledge from a research study through citations of the work by other authors. This was a citation analysis study to explore the dissemination of research into the clinical nursing literature, beginning with the publication of an original research study and including all of the citations to that article through 2009. The authors searched five academic nursing research journal titles, using CINAHL, for original research reports that had clinical relevance and were published between 1990-1999. The search process yielded a final data set of 28 research articles. For each of the articles, the authors searched three databases, CINAHL, Web of Science(®) and Google Scholar, to determine the citation patterns from the date of publication to August 2009. All of the research studies were cited in articles published in clinical journals although there was a wide range in the number of citations, from 3-80. The 28 research articles had a total of 759 citations; 717 (94.5%) of those citations were in articles published in clinical nursing journals. The median length of time between publication of the original study and the first citation was 1.5 years. Some of the studies were still being cited for 18 years after publication of the original work. All of the original research reports examined in this study were cited in articles in clinical journals, disseminating the research beyond the original work to reach clinicians. Clinical nursing journals keep readers up-to-date and informed about new practices in nursing and serve another important role: they disseminate research that is clinically relevant by publishing original studies and papers that cite research reports. © 2010 Blackwell Publishing Ltd.
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Ganguli, Arijit; Clewell, Jerry; Shillington, Alicia C
2016-01-01
Background Patient support programs (PSPs), including medication management and counseling, have the potential to improve care in chronic disease states with complex therapies. Little is known about the program’s effects on improving clinical, adherence, humanistic, and cost outcomes. Purpose To conduct a targeted review describing medical conditions in which PSPs have been implemented; support delivery components (eg, face-to-face, phone, mail, and internet); and outcomes associated with implementation. Data sources MEDLINE – 10 years through March 2015 with supplemental handsearching of reference lists. Study selection English-language trials and observational studies of PSPs providing at minimum, counseling for medication management, measurement of ≥1 clinical outcome, and a 3-month follow-up period during which outcomes were measured. Data extraction Program characteristics and related clinical, adherence, humanistic, and cost outcomes were abstracted. Study quality and the overall strength of evidence were reviewed using standard criteria. Data synthesis Of 2,239 citations, 64 studies met inclusion criteria. All targeted chronic disease processes and the majority (48 [75%]) of programs offered in-clinic, face-to-face support. All but 9 (14.1%) were overseen by allied health care professionals (eg, nurses, pharmacists, paraprofessionals). Forty-one (64.1%) reported at least one significantly positive clinical outcome. The most frequent clinical outcome impacted was adherence, where 27 of 41 (66%) reported a positive outcome. Of 42 studies measuring humanistic outcomes (eg, quality of life, functional status), 27 (64%) reported significantly positive outcomes. Only 15 (23.4%) programs reported cost or utilization-related outcomes, and, of these, 12 reported positive impacts. Conclusion The preponderance of evidence suggests a positive impact of PSPs on adherence, clinical and humanistic outcomes. Although less often measured, health care utilization and costs are also reduced following PSP implementation. Further research is needed to better quantify which support programs, delivery methods, and components offer the greatest value for any particular medical condition. PMID:27175071
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Lelli, Filippo; Nuhoho, Solomon; Lee, Xin Ying; Xu, Weiwei
2016-01-01
Background Although many clinical trials have been conducted in treatments of Crohn’s disease (CD), whether the trial results were representative of daily practice needs to be supported by studies conducted in real-world settings. Aim This study aims to identify how CD is treated and what are the clinical effectiveness and safety of the pharmaceutical therapies of CD in real-world settings. Methods A systematic literature review was conducted based on Medline®, Embase®, and Cochrane. All publications were assessed for title/abstract and full-text according to a predefined study protocol. Data were extracted and reported. Results A total of 1,998 publications were identified. Fifty studies including six publications reporting treatment pattern and 44 studies reporting clinical effectiveness and safety of pharmaceutical therapies in CD management in Europe were included. 5-Aminosalicylic acid and corticosteroids were reported to be used among 14%–74% of CD patients. Immunomodulators were used by 14%–25% and 29%–31% of CD patients as an initial and follow-up treatment, respectively. Biological therapies were used by 25%–33% of CD patients. A trend toward an increasing use of immunomodulators and biological therapies in Europe has been reported in recent years. Approximately 50% of patients achieved remission on immunomodulator or biologic treatment, although a relapse rate of up to 23% has been reported. Conclusion There is a trend of treatment shift to immunomodulators and biologics in CD management. Clinical effectiveness of immunomodulators and biologics has been demonstrated, though with a lack of sustainability of the effectiveness. PMID:27785086
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Lelli, Filippo; Nuhoho, Solomon; Lee, Xin Ying; Xu, Weiwei
2016-01-01
Although many clinical trials have been conducted in treatments of Crohn's disease (CD), whether the trial results were representative of daily practice needs to be supported by studies conducted in real-world settings. This study aims to identify how CD is treated and what are the clinical effectiveness and safety of the pharmaceutical therapies of CD in real-world settings. A systematic literature review was conducted based on Medline ® , Embase ® , and Cochrane. All publications were assessed for title/abstract and full-text according to a predefined study protocol. Data were extracted and reported. A total of 1,998 publications were identified. Fifty studies including six publications reporting treatment pattern and 44 studies reporting clinical effectiveness and safety of pharmaceutical therapies in CD management in Europe were included. 5-Aminosalicylic acid and corticosteroids were reported to be used among 14%-74% of CD patients. Immunomodulators were used by 14%-25% and 29%-31% of CD patients as an initial and follow-up treatment, respectively. Biological therapies were used by 25%-33% of CD patients. A trend toward an increasing use of immunomodulators and biological therapies in Europe has been reported in recent years. Approximately 50% of patients achieved remission on immunomodulator or biologic treatment, although a relapse rate of up to 23% has been reported. There is a trend of treatment shift to immunomodulators and biologics in CD management. Clinical effectiveness of immunomodulators and biologics has been demonstrated, though with a lack of sustainability of the effectiveness.
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Gonçalves, Lucio Souza; Rodrigues, Renata Costa Val; Andrade Junior, Carlos Vieira; Soares, Renata G; Vettore, Mario Vianna
2016-04-01
This systematic review aimed to compare the effectiveness of sodium hypochlorite and chlorhexidine for root canal disinfection during root canal therapy. A literature search for clinical trials was made on the PubMed (MEDLINE), Web of Knowledge, SCOPUS, and Science Direct databases and in the reference lists of the identified articles up to January 2015. Quality assessment of the selected studies was performed according to the Consolidated Standards of Reporting Trials statement. One clinical trial and 4 randomized clinical trials were selected from the 172 articles initially identified. There was heterogeneity in the laboratory methods used to assess the root canal disinfection as well as in the concentrations of the irrigants used. Therefore, meta-analysis was not performed. Two studies reported effective and similar reductions in bacterial levels for both irrigants. Sodium hypochlorite was more effective than chlorhexidine in reducing microorganisms in 1 study, and another reported opposite findings. Both root irrigants were ineffective in eliminating endotoxins from necrotic pulp root canals in 1 study. Trial design and information regarding randomization procedures were not clearly described in the clinical trials. No study compared laboratory results with clinical outcomes. The available evidence on this topic is scarce, and the findings of studies were not consistent. Additional randomized clinical trials using clinical outcomes to compare the use of sodium hypochlorite and chlorhexidine during root canal therapy are needed. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.
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Samsiah, A; Othman, Noordin; Jamshed, Shazia; Hassali, Mohamed Azmi
2016-01-01
To explore and understand participants' perceptions and attitudes towards the reporting of medication errors (MEs). A qualitative study using in-depth interviews of 31 healthcare practitioners from nine publicly funded, primary care clinics in three states in peninsular Malaysia was conducted for this study. The participants included family medicine specialists, doctors, pharmacists, pharmacist assistants, nurses and assistant medical officers. The interviews were audiotaped and transcribed verbatim. Analysis of the data was guided by the framework approach. Six themes and 28 codes were identified. Despite the availability of a reporting system, most of the participants agreed that MEs were underreported. The nature of the error plays an important role in determining the reporting. The reporting system, organisational factors, provider factors, reporter's burden and benefit of reporting also were identified. Healthcare practitioners in primary care clinics understood the importance of reporting MEs to improve patient safety. Their perceptions and attitudes towards reporting of MEs were influenced by many factors which affect the decision-making process of whether or not to report. Although the process is complex, it primarily is determined by the severity of the outcome of the errors. The participants voluntarily report the errors if they are familiar with the reporting system, what error to report, when to report and what form to use.
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Macefield, Rhiannon C.; Blencowe, Natalie S.; Brookes, Sara T.; Blazeby, Jane M.
2016-01-01
Purpose The CONSORT extension for patient reported outcomes (PROs) aims to improve reporting, but guidance on the optimal integration with clinical data is lacking. This study examines in detail the reporting of PROs and clinical data from randomized controlled trials (RCTs) in gastro-intestinal cancer to inform design and reporting of combined PRO and clinical data from trials to improve the ‘take home’ message for clinicians to use in practice. Materials and Methods The case study was undertaken in gastro-intestinal cancer trials. Well-conducted RCTs reporting PROs with validated instruments were identified and categorized into those combining PRO and clinical data in a single paper, or those separating data into linked primary and supplemental papers. Qualitative methods were developed to examine reporting of the critical interpretation of the trial results (trial exegesis) in the papers in relation of the PRO and clinical outcomes and applied to each publication category. Results were used to inform recommendations for practice. Results From 1917 screened abstracts, 49 high quality RCTs were identified reported in 36 combined and 15 linked primary and supplemental papers. In-depth analysis of manuscript text identified three categories for understanding trial exegesis: where authors reported a “detailed”, “general”, or absent PRO rationale and integrated interpretation of clinical and PRO results. A total of 11 (30%) and 6 (16%) combined papers reported “detailed” PRO rationale and integrated interpretation of results although only 2 (14%) and 1 (7%) primary papers achieved the same standard respectively. Supplemental papers provide better information with 11 (73%) and 3 (20%) achieving “detailed” rationale and integrated interpretation of results. Supplemental papers, however, were published a median of 20 months after the primary RCT data in lower impact factor journals (median 16.8 versus 5.2). Conclusion It is recommended that single papers, with detailed PRO rationale and integrated PRO and clinical data are published to optimize trial exegesis. Further work to examine whether this improves the use of PRO data to inform practice is needed. PMID:27571514
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Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia
2018-05-15
To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future.
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Worcester, Marian Una Christine; Stojcevski, Zlatko; Murphy, Barbara; Goble, Alan James
2003-01-01
Secondary prevention interventions, including hospital clinics, can help patients improve their risk factors and lifestyles after an acute cardiac event. This study aimed to investigate the long-term behavioral outcomes of attending and nonattending patients consecutively enrolled in a trial of a family-based clinic providing screening, advice, and support 3 months after hospital admission. The study also aimed to identify predictors of long-term smoking status, dietary habit, and physical activity. Semistructured interviews were conducted an average of 30 months after the acute cardiac event with 83 of the 103 nonattending patients and a random sample of 96 patients who had attended the clinic. Behavioral outcomes were investigated, and self-reported risk factors at the time of the acute illness were documented. The patients who had attended the clinic were significantly more likely than nonattenders to report positive dietary changes and, among former smokers, successful cessation of smoking. Furthermore, they reported being more physically active than nonattenders. Using logistic regression, clinic attendance was identified as a significant and independent predictor of all three outcomes. The results of this observational study suggest that attendance at a secondary prevention clinic facilitates maintenance of improved long-term health behaviors, although this finding is based on self-report. Factors possibly responsible for favorable outcomes include strong physician advice and support from a multidisciplinary team of health professionals. Furthermore, the timing of the intervention may have been appropriate for enrollment in a secondary prevention clinic.
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Bouça-Machado, Raquel; Rosário, Madalena; Alarcão, Joana; Correia-Guedes, Leonor; Abreu, Daisy; Ferreira, Joaquim J
2017-01-25
Over the past decades there has been a significant increase in the number of published clinical trials in palliative care. However, empirical evidence suggests that there are methodological problems in the design and conduct of studies, which raises questions about the validity and generalisability of the results and of the strength of the available evidence. We sought to evaluate the methodological characteristics and assess the quality of reporting of clinical trials in palliative care. We performed a systematic review of published clinical trials assessing therapeutic interventions in palliative care. Trials were identified using MEDLINE (from its inception to February 2015). We assessed methodological characteristics and describe the quality of reporting using the Cochrane Risk of Bias tool. We retrieved 107 studies. The most common medical field studied was oncology, and 43.9% of trials evaluated pharmacological interventions. Symptom control and physical dimensions (e.g. intervention on pain, breathlessness, nausea) were the palliative care-specific issues most studied. We found under-reporting of key information in particular on random sequence generation, allocation concealment, and blinding. While the number of clinical trials in palliative care has increased over time, methodological quality remains suboptimal. This compromises the quality of studies. Therefore, a greater effort is needed to enable the appropriate performance of future studies and increase the robustness of evidence-based medicine in this important field.
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Database on veterinary clinical research in homeopathy.
Clausen, Jürgen; Albrecht, Henning
2010-07-01
The aim of the present report is to provide an overview of the first database on clinical research in veterinary homeopathy. Detailed searches in the database 'Veterinary Clinical Research-Database in Homeopathy' (http://www.carstens-stiftung.de/clinresvet/index.php). The database contains about 200 entries of randomised clinical trials, non-randomised clinical trials, observational studies, drug provings, case reports and case series. Twenty-two clinical fields are covered and eight different groups of species are included. The database is free of charge and open to all interested veterinarians and researchers. The database enables researchers and veterinarians, sceptics and supporters to get a quick overview of the status of veterinary clinical research in homeopathy and alleviates the preparation of systematical reviews or may stimulate reproductions or even new studies. 2010 Elsevier Ltd. All rights reserved.
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Mukamel, Dana B; Spector, William D; Zinn, Jacqueline; Weimer, David L; Ahn, Richard
2010-10-01
Nursing Home Compare first published clinical quality measures at the end of 2002. It is a quality report card that for the first time offers consumers easily accessible information about the clinical quality of nursing homes. It led to changes in consumers' demand, increasing the relative importance of clinical versus hotel aspects of quality in their search and choice of a nursing home. To examine the hypothesis that nursing homes responding to these changes in demand shifted the balance of resources from hotel to clinical activities. The study included 10,022 free-standing nursing homes nationwide during 2001 to 2006. RESEARCH DESIGN AND DATA: A retrospective multivariate statistical analysis of trends in the ratio of clinical to hotel expenditures, using Medicare cost reports, Minimum Data Set and Online Survey, Certification and Reporting data, controlling for changes in residents' acuity and facility fixed effects. Inference is based on robust standard errors. The ratio of clinical to hotel expenditures averaged 1.78. It increased significantly (P < 0.001) by 5% following the publication of the report card. The increase was larger and more significant among nursing homes with worse reported quality, lower occupancy, those located in more competitive markets, for-profit ownership and owned by a chain. The increase in the ratio of clinical to hotel expenditures following publication of the report card suggests that nursing homes responded as expected to the changes in the elasticity of demand with respect to clinical quality brought about by the public reporting of clinical quality measures. The response was stronger among nursing homes facing stronger incentives.
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Mottura, A Aldo; Del Castillo, René
2007-01-01
In recent years, some surgeons have been warned of possible problems with sentinel lymph node diagnosis (SLND) for patients who have undergone transaxillary breast augmentation (TBA), although no scientific studies support this warning. The authors report two additional cases of breast cancer in which the SLND was successfully performed for patients with previous TBA. The surgical anatomy of the axilla, the groups of lymph nodes, and a personal way of performing TBA are described. Five other reports concerning the same issue are thoroughly discussed. Four of these are clinical in vivo reports, and one is a cadaver study. The four in vivo studies and what we are reporting now clearly demonstrate that what was said regarding possible problems in the SLND after TBA was not founded on clinical research and contradicts these five clinical findings.
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NASA Astrophysics Data System (ADS)
Daly, S.; Rainford, L.; Butler, M. L.
2014-03-01
Several studies have demonstrated the importance of environmental conditions in the radiology reporting environment, with many indicating that incorrect parameters could lead to error and misinterpretation. Literature is available with recommendations as to the levels that should be achieved in clinical practice, but evidence of adherence to these guidelines in radiology reporting environments is absent. This study audited the reporting environments of four teleradiologist and eight hospital based radiology reporting areas. This audit aimed to quantify adherence to guidelines and identify differences in the locations with respect to layout and design, monitor distance and angle as well as the ambient factors of the reporting environments. In line with international recommendations, an audit tool was designed to enquire in relation to the layout and design of reporting environments, monitor angle and distances used by radiologists when reporting, as well as the ambient factors such as noise, light and temperature. The review of conditions were carried out by the same independent auditor for consistency. The results obtained were compared against international standards and current research. Each radiology environment was given an overall compliance score to establish whether or not their environments were in line with recommended guidelines. Poor compliance to international recommendations and standards among radiology reporting environments was identified. Teleradiology reporting environments demonstrated greater compliance than hospital environments. The findings of this study identified a need for greater awareness of environmental and perceptual issues in the clinical setting. Further work involving a larger number of clinical centres is recommended.
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Refining the structure and content of clinical genomic reports.
Dorschner, Michael O; Amendola, Laura M; Shirts, Brian H; Kiedrowski, Lesli; Salama, Joseph; Gordon, Adam S; Fullerton, Stephanie M; Tarczy-Hornoch, Peter; Byers, Peter H; Jarvik, Gail P
2014-03-01
To effectively articulate the results of exome and genome sequencing we refined the structure and content of molecular test reports. To communicate results of a randomized control trial aimed at the evaluation of exome sequencing for clinical medicine, we developed a structured narrative report. With feedback from genetics and non-genetics professionals, we developed separate indication-specific and incidental findings reports. Standard test report elements were supplemented with research study-specific language, which highlighted the limitations of exome sequencing and provided detailed, structured results, and interpretations. The report format we developed to communicate research results can easily be transformed for clinical use by removal of research-specific statements and disclaimers. The development of clinical reports for exome sequencing has shown that accurate and open communication between the clinician and laboratory is ideally an ongoing process to address the increasing complexity of molecular genetic testing. © 2014 Wiley Periodicals, Inc.
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Refining the Structure and Content of Clinical Genomic Reports
DORSCHNER, MICHAEL O.; AMENDOLA, LAURA M.; SHIRTS, BRIAN H.; KIEDROWSKI, LESLI; SALAMA, JOSEPH; GORDON, ADAM S.; FULLERTON, STEPHANIE M.; TARCZY-HORNOCH, PETER; BYERS, PETER H.; JARVIK, GAIL P.
2014-01-01
To effectively articulate the results of exome and genome sequencing we refined the structure and content of molecular test reports. To communicate results of a randomized control trial aimed at the evaluation of exome sequencing for clinical medicine, we developed a structured narrative report. With feedback from genetics and non-genetics professionals, we developed separate indication-specific and incidental findings reports. Standard test report elements were supplemented with research study-specific language, which highlighted the limitations of exome sequencing and provided detailed, structured results, and interpretations. The report format we developed to communicate research results can easily be transformed for clinical use by removal of research-specific statements and disclaimers. The development of clinical reports for exome sequencing has shown that accurate and open communication between the clinician and laboratory is ideally an ongoing process to address the increasing complexity of molecular genetic testing. PMID:24616401
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Panagopoulos, John; Hush, Julia; Steffens, Daniel; Hancock, Mark J
2017-04-01
Systematic review OBJECTIVE.: The aim of the study was to investigate whether magnetic resonance imaging (MRI) findings change over a relatively short period of time (<1 yr) in people with low back pain (LBP) or sciatica. We also investigated whether there was an association between any change in MRI findings and change in clinical outcomes. MRI offers the potential to identify possible pathoanatomic sources of LBP and/or sciatica; however, the clinical importance of MRI findings remains unclear. Little is known about whether lumbar MRI findings change over the short term and if so whether these changes are associated with changes in clinical outcomes. Medline, EMBASE, and CINAHL databases were searched. Included were cohort studies that performed repeat MRI scans within 12 months in patients with LBP and/or sciatica. Data on study characteristics and change in MRI findings were extracted from included studies. Any data describing associations between change in MRI findings and change in clinical outcomes were also extracted. A total of 12 studies met the inclusion criteria and were included in the review. Pooling was not possible due to heterogeneity of studies and findings. Seven studies reported on changes in disc herniation and reported 15% to 93% of herniations reduced or disappeared in size. Two studies reported on changes in nerve root compression and reported 17% to 91% reduced or disappeared. Only one study reported on the association between change in MRI findings and change in clinical outcomes within 1 year, and found no association. This review found moderate evidence that the natural course of herniations and nerve root compression is favorable over a 1-year period in people with sciatica or LBP. There is a lack of evidence on whether other MRI findings change, and whether changes in MRI findings are associated with changes in clinical outcomes. 1.
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RICKETS IN RURAL KENYAN PRESCHOOL CHILDREN: CASE REPORT.
Bwibo, N O; Nyawade, S; Neumann, C G
2013-03-01
Clinical rickets has not been reported previously in Embu district, Kenya. Baseline clinical assessments performed for a nutrition intervention study in preschool children (n=324) identified 28 cases of rickets (8.6% of study sample). Clinical characteristics included: delays of sitting, walking, and teething; bone and chest deformities; widened wrists and ankles; and bowed lower extremities. Risk factors identified were short duration of breastfeeding with feeding of cereal-based supplements with little or no milk, low calcium intake, limited sunlight exposure. Vitamin D and calcium deficiencies likely contributed to these cases. Treatment with Vitamin D3 and milk resulted in clinical improvement.
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Huang, Grace C; Almeida, Jacqueline M; Roberts, David H
2012-01-01
Logbooks are used by US medical schools to evaluate curricular objectives and meet accreditation requirements, but research supporting their utility is conflicting. The goal of our study was to examine the relationship between volume of clinical rotation experiences as reported in a logbook and clerkship grades within a longitudinal integrated clerkship. We conducted a retrospective cohort study of third-year (clinical) medical students during academic year 2008-2009. We tracked student entries in a pocket-sized logbook (number of clinical encounters per clerkship, total number of exams, and procedures over the academic year). We performed correlation analyses between logbook entries and clerkship grades. We enrolled 36 students, who reported a total of 2992 encounters, 2262 exams, and 2342 procedures. Correlation coefficients between volume of clinical experience and clerkship grades were less than 0.4, indicating low correlation. We found borderline statistical significance for the Neurology, OB/Gyn, and Surgery clerkships. Sensitivity analyses showed little correlation between low-reporting activity and clerkship grades. Even within an integrated longitudinal clerkship framework, our findings are consistent with previous studies showing a negligible relationship between logbooks as an educational process measure and how they relate to educational outcomes.
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Kulak, David; Jindal, Sangita K; Oh, Cheongeun; Morelli, Sara S; Kratka, Scott; McGovern, Peter G
2016-04-01
To assess the relationship between live birth rates (LBRs) and the incidence of under-reported cycles by IVF clinics. Cohort study. Not applicable. All patients undergoing IVF cycles in the aforementioned clinics. Not applicable. The reporting percentage (RP), defined as number of cycles with reported pregnancy rates divided by total cycles performed. Results from cryopreservation cycles are only presented by SART if an embryo transfer occurs. Thus, RP decreases as incidence of embryo or oocyte banking cycles increases. The LBRs in women aged <35 years were compared between clinics. The median RP of all clinics was 93%-97%. Clinics with RP <80% increased from 2 in 2004 to 30 in 2012. Twenty-one clinics had an RP that fell 2 standard deviations below the mean in any year. Over the 9 years, there was a negative correlation between RP and LBR of -0.17, but for the 21 outlier clinics the correlation increased to -0.26. In 2012 alone, in outlier clinics, for every 10% drop in RP there was an associated rise in LBR of 4.3%; some clinics reported 40% fewer cycles than the median. In clinics with very low RP, the cycles that are reported have higher success rates. Regardless of intent, the reduction of reported data to SART makes it increasingly difficult for clinicians and patients to accurately assess a clinic's success rates. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.
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Knopp, K L; Stenfors, C; Baastrup, C; Bannon, A W; Calvo, M; Caspani, O; Currie, G; Finnerup, N B; Huang, W; Kennedy, J D; Lefevre, I; Machin, I; Macleod, M; Rees, H; Rice, A S C; Rutten, K; Segerdahl, M; Serra, J; Wodarski, R; Berge, O-G; Treedef, R-D
2017-12-29
Background and aims Pain is a subjective experience, and as such, pre-clinical models of human pain are highly simplified representations of clinical features. These models are nevertheless critical for the delivery of novel analgesics for human pain, providing pharmacodynamic measurements of activity and, where possible, on-target confirmation of that activity. It has, however, been suggested that at least 50% of all pre-clinical data, independent of discipline, cannot be replicated. Additionally, the paucity of "negative" data in the public domain indicates a publication bias, and significantly impacts the interpretation of failed attempts to replicate published findings. Evidence suggests that systematic biases in experimental design and conduct and insufficiencies in reporting play significant roles in poor reproducibility across pre-clinical studies. It then follows that recommendations on how to improve these factors are warranted. Methods Members of Europain, a pain research consortium funded by the European Innovative Medicines Initiative (IMI), developed internal recommendations on how to improve the reliability of pre-clinical studies between laboratories. This guidance is focused on two aspects: experimental design and conduct, and study reporting. Results Minimum requirements for experimental design and conduct were agreed upon across the dimensions of animal characteristics, sample size calculations, inclusion and exclusion criteria, random allocation to groups, allocation concealment, and blinded assessment of outcome. Building upon the Animals in Research: Reportingin vivo Experiments (ARRIVE) guidelines, reporting standards were developed for pre-clinical studies of pain. These include specific recommendations for reporting on ethical issues, experimental design and conduct, and data analysis and interpretation. Key principles such as sample size calculation, a priori definition of a primary efficacy measure, randomization, allocation concealments, and blinding are discussed. In addition, considerations of how stress and normal rodent physiology impact outcome of analgesic drug studies are considered. Flow diagrams are standard requirements in all clinical trials, and flow diagrams for preclinical trials, which describe number of animals included/excluded, and reasons for exclusion are proposed. Creation of a trial registry for pre-clinical studies focused on drug development in order to estimate possible publication bias is discussed. Conclusions More systematic research is needed to analyze how inadequate internal validity and/or experimental bias may impact reproducibility across pre-clinical pain studies. Addressing the potential threats to internal validity and the sources of experimental biases, as well as increasing the transparency in reporting, are likely to improve preclinical research broadly by ensuring relevant progress is made in advancing the knowledge of chronic pain pathophysiology and identifying novel analgesics. Implications We are now disseminating these Europain processes for discussion in the wider pain research community. Any benefit from these guidelines will be dependent on acceptance and disciplined implementation across pre-clinical laboratories, funding agencies and journal editors, but it is anticipated that these guidelines will be a first step towards improving scientific rigor across the field of pre-clinical pain research.
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Clinical Trials in Benign Prostatic Hyperplasia: A Moving Target of Success.
Thomas, Dominique; Chung, Caroline; Zhang, Yiye; Te, Alexis; Gratzke, Christian; Woo, Henry; Chughtai, Bilal
2018-05-24
Benign prostatic hyperplasia (BPH) affects over 50% of men above the age of 50 yr. With half of these men having bothersome lower urinary tract symptoms, this area represents a hot bed of novel treatments. Many BPH therapies have favorable short-term outcomes but lack durability or well-defined adverse events (AEs). Clinical trials are a gold standard for comparing treatments. We characterized all BPH clinical trials registered worldwide from inception to 2017. A total of 251 clinical trials were included. Of the studies, 30.1% used patient-reported outcomes such as the American Urological Association Symptom Score. Approximately 70% of clinical trials studied medical interventions, while the remaining trials investigated surgical approaches. Seventy-nine percent of trials were industry sponsored, while a minority were funded without commercial interest. Only 42% of trials had 12-mo follow-up, with the majority with <3 mo of follow-up. No trials evaluated prevention, diet, behavior, or alternative methods Overall, only 23% of trials reported results. Management options for BPH need unified benchmarks of success, AEs, durability, and standard reporting for all clinical trials, regardless of outcomes. We found that the majority of clinical trials were medical intervention, with very few trials evaluating prevention, diet, behavior, or alternative methods Furthermore, a few trials reported results in peer-reviewed journals. All clinical trials need to report results regardless of outcome, and in conclusion, standardized methods are needed in order to document the successes, adverse events, and durability for all clinical trials. Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.
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Soliday, Elizabeth; Betts, Debra
2018-02-01
Clinic-based acupuncturists, midwives, and physiotherapists have reported using acupuncture to treat lumbopelvic pain in pregnancy, a common condition that may affect functioning and quality of life. To contribute to the emerging evidence on treatment outcomes, we collected patient-reported pain reduction data from women treated during pregnancy in a no-pay, hospital-based acupuncture service in New Zealand. Observational study of patient-reported symptom reduction.The main outcome measure was the MYMOP (Measure Your Medical Outcome Profile), a brief, validated self-report instrument. Open-ended questions on treatment experiences and adverse events were included. Of the 81 women on whom we had complete treatment data, the majority (N = 72, 89%) reported clinically meaningful symptom reduction. Patient-reported adverse events were infrequent and mild. Patient-reported and treatment-related lumbopelvic pain symptom reduction findings provide further evidence that acupuncture in pregnancy is safe and beneficial in a field setting. We discuss this study's unique contributions in providing guidance for clinicians who practice acupuncture in pregnancy, including midwives, physiotherapists, and physicians. Copyright © 2018. Published by Elsevier B.V.
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Watt, Stuart; Jiao, Wei; Brown, Andrew M K; Petrocelli, Teresa; Tran, Ben; Zhang, Tong; McPherson, John D; Kamel-Reid, Suzanne; Bedard, Philippe L; Onetto, Nicole; Hudson, Thomas J; Dancey, Janet; Siu, Lillian L; Stein, Lincoln; Ferretti, Vincent
2013-09-01
Using sequencing information to guide clinical decision-making requires coordination of a diverse set of people and activities. In clinical genomics, the process typically includes sample acquisition, template preparation, genome data generation, analysis to identify and confirm variant alleles, interpretation of clinical significance, and reporting to clinicians. We describe a software application developed within a clinical genomics study, to support this entire process. The software application tracks patients, samples, genomic results, decisions and reports across the cohort, monitors progress and sends reminders, and works alongside an electronic data capture system for the trial's clinical and genomic data. It incorporates systems to read, store, analyze and consolidate sequencing results from multiple technologies, and provides a curated knowledge base of tumor mutation frequency (from the COSMIC database) annotated with clinical significance and drug sensitivity to generate reports for clinicians. By supporting the entire process, the application provides deep support for clinical decision making, enabling the generation of relevant guidance in reports for verification by an expert panel prior to forwarding to the treating physician. Copyright © 2013 Elsevier Inc. All rights reserved.
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Effect of GH/IGF-1 on Bone Metabolism and Osteoporsosis
Locatelli, Vittorio; Bianchi, Vittorio E.
2014-01-01
Background. Growth hormone (GH) and insulin-like growth factor (IGF-1) are fundamental in skeletal growth during puberty and bone health throughout life. GH increases tissue formation by acting directly and indirectly on target cells; IGF-1 is a critical mediator of bone growth. Clinical studies reporting the use of GH and IGF-1 in osteoporosis and fracture healing are outlined. Methods. A Pubmed search revealed 39 clinical studies reporting the effects of GH and IGF-1 administration on bone metabolism in osteopenic and osteoporotic human subjects and on bone healing in operated patients with normal GH secretion. Eighteen clinical studies considered the effect with GH treatment, fourteen studies reported the clinical effects with IGF-1 administration, and seven related to the GH/IGF-1 effect on bone healing. Results. Both GH and IGF-1 administration significantly increased bone resorption and bone formation in the most studies. GH/IGF-1 administration in patients with hip or tibial fractures resulted in increased bone healing, rapid clinical improvements. Some conflicting results were evidenced. Conclusions. GH and IGF-1 therapy has a significant anabolic effect. GH administration for the treatment of osteoporosis and bone fractures may greatly improve clinical outcome. GH interacts with sex steroids in the anabolic process. GH resistance process is considered. PMID:25147565
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Klein-Fedyshin, Michele; Ketchum, Andrea M; Arnold, Robert M; Fedyshin, Peter J
2014-12-01
MEDLINE offers the Core Clinical Journals filter to limit to clinically useful journals. To determine its effectiveness for searching and patient-centric decision making, this study compared literature used for Morning Report in Internal Medicine with journals in the filter. An EndNote library with references answering 327 patient-related questions during Morning Report from 2007 to 2012 was exported to a file listing variables including designated Core Clinical Journal, Impact Factor, date used and medical subject. Bradford's law of scattering was applied ranking the journals and reflecting their clinical utility. Recall (sensitivity) and precision of the Core Morning Report journals and non-Core set was calculated. This study applied bibliometrics to compare the 628 articles used against these criteria to determine journals impacting decision making. Analysis shows 30% of clinically used articles are from the Core Clinical Journals filter and 16% of the journals represented are Core titles. When Bradford-ranked, 55% of the top 20 journals are Core. Articles <5 years old furnish 63% of sources used. Among the 63 Morning Report subjects, 55 have <50% precision and 41 have <50% recall including 37 subjects with 0% precision and 0% recall. Low usage of publications within the Core Clinical Journals filter indicates less relevance for hospital-based care. The divergence from high-impact medicine titles suggests clinically valuable journals differ from academically important titles. With few subjects demonstrating high recall or precision, the MEDLINE Core Clinical Journals filter may require a review and update to better align with current clinical needs. © 2014 John Wiley & Sons, Ltd.
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The Clinical Research Landscape in Rhode Island.
Mao, George; Ramratnam, Bharat
2017-01-06
To present an overview of clinical research activity and the state of medical research funding in Rhode Island. We utilized clinicaltrials.gov registry to profile clinical studies between 2011 to 2016. NIH RePORT and other federal databases were used to extract information on levels of federal funding. Previously published hospital financial reports were reviewed for data on hospital-specific total external research funding. During 2011-2016, 1651 clinical studies were registered in clinicaltrials.gov. Nearly a third of all clinical studies were in oncology (21%) and cardiovascular diseases (10%). Alzheimer's dementia, breast cancer, HIV, and hepatitis C accounted for nearly 17% of all clinical trials. Seventy-five percent (75%) of clinical trials in RI were conducted in hospitals affiliated with Lifespan or Care New England. Financial support for clinical trials largely came from industry (60%) with 23% being supported by the National Institutes of Health (NIH). The rest are funded by nonprofit organizations, charitable foundations, educational institutions, and unlisted concerns. [Full article available at http://rimed.org/rimedicaljournal-2017-01.asp].
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Gender bias in clinical case reports: A cross-sectional study of the "big five" medical journals.
Allotey, Pascale; Allotey-Reidpath, Caitlin; Reidpath, Daniel D
2017-01-01
Gender bias in medical journals can affect the science and the benefit to patients. It has never been investigated in clinical case reports. The oversight is important because of the role clinical case reports play in hypothesis generation and medical education. We investigated contemporary gender bias in case reports for the highest ranked journals in general and internal medicine. PubMed case reports data from 2011 to 2016 were extracted for the Annals of Internal Medicine, British Medical Journal, the Journal of the American Medical Association, The Lancet, and New England Journal of Medicine. The gender of the patients were identified and a text analysis of the Medical Subject Headings conducted. A total of 2,742 case reports were downloaded and 2,582 (95.6%) reports contributed to the final analysis. A pooled analysis showed a statistically significant gender bias against female case reports (0.45; 95%CI: 0.43-0.47). The Annals of Internal Medicine was the only journal with a point estimate (non significant) in the direction of a bias against male patients. The text analysis identified no substantive difference in the focus of the case reports and no obvious explanation for the bias. Gender bias, previously identified in clinical research and in clinical authorship, extends into the patients presented in clinical case reports. Whether it is driven by authors or editors is not clear, but it likely contributes to and supports an overall male bias of clinical medicine.
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Møller, Turid; Linaker, Olav M
2010-04-01
The aims of this study were to examine evidence for the concurrent validity of two self-report measures and two staff-report measures measuring alcohol and drug problems in seriously mentally ill people and to examine if psychotic patients under-report their alcohol and drug problems in an early intervention clinic. This is a cross-sectional study of 48 patients (26 inpatients and 22 outpatients) from an early intervention clinic for psychosis. To examine the sensitivity and specificity, we compared both the staff-report measures Clinical Alcohol Use Scale (AUS) and Clinical Drug Use Scale (DUS) and the self-report measures Short Michigan Alcohol Screening Test (SMAST-13) and Drug Abuse Screening Test (DAST-20), with the current ICD-10 diagnostic criteria as the gold-standard for alcohol and drug problems. To examine whether the patients under-report their alcohol and drug problems, we also compared the self-report measures SMAST-13 and DAST-20 with the staff-report measures AUS and DUS and ICD-10 consensus substance abuse diagnoses. The results show that the concurrent validity compared with ICD-10 diagnoses was moderate for both the staff-report measures AUS and DUS and for the self-report measures SMAST-13 and DAST-20. Three out of seven patients under-report alcohol problems and one patient out of seven under-report drug use problems according to consensus ICD-10 substance abuse diagnoses. We conclude that the SMAST-13 and DAST-20 in combination with the AUS and DUS, which are easy and quick to perform, are helpful in establishing a common understanding of the patient's alcohol and drug problems in an early intervention clinic.
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Martins, Júlia Caetano; Aguiar, Larissa Tavares; Nadeau, Sylvie; Scianni, Aline Alvim; Teixeira-Salmela, Luci Fuscaldi; Faria, Christina Danielli Coelho de Morais
2017-01-01
Introduction Self-report physical activity assessment tools are commonly used for the evaluation of physical activity levels in individuals with stroke. A great variety of these tools have been developed and widely used in recent years, which justify the need to examine their measurement properties and clinical utility. Therefore, the main objectives of this systematic review are to examine the measurement properties and clinical utility of self-report measures of physical activity and discuss the strengths and limitations of the identified tools. Methods and analysis A systematic review of studies that investigated the measurement properties and/or clinical utility of self-report physical activity assessment tools in stroke will be conducted. Electronic searches will be performed in five databases: Medical Literature Analysis and Retrieval System Online (MEDLINE) (PubMed), Excerpta Medica Database (EMBASE), Physiotherapy Evidence Database (PEDro), Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) and Scientific Electronic Library Online (SciELO), followed by hand searches of the reference lists of the included studies. Two independent reviewers will screen all retrieve titles, abstracts, and full texts, according to the inclusion criteria and will also extract the data. A third reviewer will be referred to solve any disagreement. A descriptive summary of the included studies will contain the design, participants, as well as the characteristics, measurement properties, and clinical utility of the self-report tools. The methodological quality of the studies will be evaluated using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist and the clinical utility of the identified tools will be assessed considering predefined criteria. This systematic review will follow the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) statement. Discussion This systematic review will provide an extensive review of the measurement properties and clinical utility of self-report physical activity assessment tools used in individuals with stroke, which would benefit clinicians and researchers. Trial registration number PROSPERO CRD42016037146. PMID:28193848
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Lumbreras-Lacarra, Blanca; Ramos-Rincón, José Manuel; Hernández-Aguado, Ildefonso
2004-03-01
The application of epidemiologic principles to clinical diagnosis has been less developed than in other clinical areas. Knowledge of the main flaws affecting diagnostic laboratory test research is the first step for improving its quality. We assessed the methodologic aspects of articles on laboratory tests. We included articles that estimated indexes of diagnostic accuracy (sensitivity and specificity) and were published in Clinical Chemistry or Clinical Chemistry and Laboratory Medicine in 1996, 2001, and 2002. Clinical Chemistry has paid special attention to this field of research since 1996 by publishing recommendations, checklists, and reviews. Articles were identified through electronic searches in Medline. The strategy combined the Mesh term "sensitivity and specificity" (exploded) with the text words "specificity", "false negative", and "accuracy". We examined adherence to seven methodologic criteria used in the study by Reid et al. (JAMA1995;274:645-51) of papers published in general medical journals. Three observers evaluated each article independently. Seventy-nine articles fulfilled the inclusion criteria. The percentage of studies that satisfied each criterion improved from 1996 to 2002. Substantial improvement was observed in reporting of the statistical uncertainty of indices of diagnostic accuracy, in criteria based on clinical information from the study population (spectrum composition), and in avoidance of workup bias. Analytical reproducibility was reported frequently (68%), whereas information about indeterminate results was rarely provided. The mean number of methodologic criteria satisfied showed a statistically significant increase over the 3 years in Clinical Chemistry but not in Clinical Chemistry and Laboratory Medicine. The methodologic quality of the articles on diagnostic test research published in Clinical Chemistry and Clinical Chemistry and Laboratory Medicine is comparable to the quality observed in the best general medical journals. The methodologic aspects that most need improvement are those linked to the clinical information of the populations studied. Editorial actions aimed to increase the quality of reporting of diagnostic studies could have a relevant positive effect, as shown by the improvement observed in Clinical Chemistry.
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Corrections of clinical chemistry test results in a laboratory information system.
Wang, Sihe; Ho, Virginia
2004-08-01
The recently released reports by the Institute of Medicine, To Err Is Human and Patient Safety, have received national attention because of their focus on the problem of medical errors. Although a small number of studies have reported on errors in general clinical laboratories, there are, to our knowledge, no reported studies that focus on errors in pediatric clinical laboratory testing. To characterize the errors that have caused corrections to have to be made in pediatric clinical chemistry results in the laboratory information system, Misys. To provide initial data on the errors detected in pediatric clinical chemistry laboratories in order to improve patient safety in pediatric health care. All clinical chemistry staff members were informed of the study and were requested to report in writing when a correction was made in the laboratory information system, Misys. Errors were detected either by the clinicians (the results did not fit the patients' clinical conditions) or by the laboratory technologists (the results were double-checked, and the worksheets were carefully examined twice a day). No incident that was discovered before or during the final validation was included. On each Monday of the study, we generated a report from Misys that listed all of the corrections made during the previous week. We then categorized the corrections according to the types and stages of the incidents that led to the corrections. A total of 187 incidents were detected during the 10-month study, representing a 0.26% error detection rate per requisition. The distribution of the detected incidents included 31 (17%) preanalytic incidents, 46 (25%) analytic incidents, and 110 (59%) postanalytic incidents. The errors related to noninterfaced tests accounted for 50% of the total incidents and for 37% of the affected tests and orderable panels, while the noninterfaced tests and panels accounted for 17% of the total test volume in our laboratory. This pilot study provided the rate and categories of errors detected in a pediatric clinical chemistry laboratory based on the corrections of results in the laboratory information system. A direct interface of the instruments to the laboratory information system showed that it had favorable effects on reducing laboratory errors.
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Vinluan, Jessele; Retegan, Claudia; Chen, Andrew; Beiles, Charles Barry
2014-01-01
Objective Clinical management issues are contributory factors to mortality. The aim of this study was to use data from the Victorian Audit of Surgical Mortality (VASM), an educational peer-review process for surgeons, to discover differences in the incidence of these issues between surgical specialties in order to focus attention to areas of care that might be improved. Design This study used retrospectively analysed observational data from VASM. Clinical management issues between eight specialties were assessed using χ2 analysis. Data sources VASM data were reported by participating public and private health services, the Coroner and self-reporting surgeons across Victoria. Results A total of 2946 specific clinical issues as deficiencies of care were reported. 15% of cases had significant issues of care. The most common clinical management issue was the delay in delivery of treatment. Other clinical issues included the quality of communication and documentation, preoperative and postoperative care, adverse events and protocol issues. There were significant differences in issues between specialties. Conclusions The clinical management issues presented across surgical specialties were similar; however, five issues of clinical care differed significantly in frequency across surgical specialties. The three main issues varying among specialties were complications after operation, communication and postoperative care. Addressing these clinical management issues via the peer-review process may impact positively on patient care. PMID:24980043
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Park, Angela; Barrera-Ramirez, Juliana; Ranasinghe, Indee; Pilon, Sophie; Sy, Richmond; Fergusson, Dean; Allan, David S
2016-06-01
Mesenchymal stromal cells (MSCs) and endothelial progenitor cells (EPCs) are used in cell-based regenerative therapy. HMG CoA reductase inhibitors (statins) appear promising in blocking apoptosis, prolonging progenitor cell survival and improving their capacity to repair organ function. We performed a systematic review of preclinical and clinical studies to clarify whether statins can improve cell-based repair of organ injury. MEDLINE, EMBASE, and PUBMED databases were searched (1947 to June 25, 2013). Controlled clinical and pre-clinical studies were included that evaluated statin therapy used alone or in combination with MSCs or EPCs in patients or animals with organ injury. After screening 771 citations, 100 records underwent full eligibility screening of which 38 studies met eligibility and were included in the review: Studies were grouped into pre-clinical studies that involved statin treatment in combination with cell therapy (18 studies), preclinical studies of statin therapy alone (13 studies) and clinical studies of statin therapy (7 studies). Studies addressed cardiac injury (14 studies), vascular disorders (15 studies), neurologic conditions (8 studies) and bone fractures (1 study). Pre-clinical studies of statins in combination with MSC infusion (15 studies) or EPC therapy (3 studies) were described and despite marked heterogeneity in reporting outcomes of cellular analysis and organ function, all of these cell-based pre-clinical studies reported improved organ recovery with the addition of statin therapy. Moreover, 13 pre-clinical studies involved the administration of a statin drug alone to animals. An increase in EPC number and/or function (no studies of MSCs) was reported in 11 of these studies (85 %) and improved organ function in 12 studies (92 %). We also identified 7 clinical studies and none involved the administration of cells but described an increased number and/or function of EPCs (no studies of MSCs) and improved organ function with statin therapy (1.2-fold to 35-fold improvement over controls) in all 7 studies. Our systematic review provides a foundation of encouraging results that support further study of statins in regenerative therapy to augment the number and/or function of MSCs used in cell-based repair and to augment the number and function of EPCs in vivo to repair damaged tissues. Larger studies are needed to ensure safety and confirm clinical benefits.
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Clinical Trials in Veterinary Medicine: A New Era Brings New Challenges.
Oyama, M A; Ellenberg, S S; Shaw, P A
2017-07-01
Randomized clinical trials (RCTs) are among the most rigorous ways to determine the causal relationship between an intervention and important clinical outcome. Their use in veterinary medicine has become increasingly common, and as is often the case, with progress comes new challenges. Randomized clinical trials yield important answers, but results from these studies can be unhelpful or even misleading unless the study design and reporting are carried out with care. Herein, we offer some perspective on several emerging challenges associated with RCTs, including use of composite endpoints, the reporting of different forms of risk, analysis in the presence of missing data, and issues of reporting and safety assessment. These topics are explored in the context of previously reported veterinary internal medicine studies as well as through illustrative examples with hypothetical data sets. Moreover, many insights germane to RCTs in veterinary internal medicine can be drawn from the wealth of experience with RCTs in the human medical field. A better understanding of the issues presented here can help improve the design, interpretation, and reporting of veterinary RCTs. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.
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Gonge, Henrik; Buus, Niels
2016-05-01
This article reports findings from a longitudinal controlled intervention study of 115 psychiatric nursing staff. The twofold objective of the study was: (a) To test whether the intervention could increase clinical supervision participation and effectiveness of existing supervision practices, and (b) To explore organizational constraints to implementation of these strengthened practices. Questionnaire responses and registration of participation in clinical supervision were registered prior and subsequent to the intervention consisting of an action learning oriented reflection on staff's existing clinical supervision practices. Major organizational changes in the intervention group during the study period obstructed the implementation of strengthened clinical supervision practices, but offered an opportunity for studying the influences of organizational constraints. The main findings were that a) diminishing experience of social support from colleagues was associated with reduced participation in clinical supervision, while b) additional quantitative demands were associated with staff reporting difficulties finding time for supervision. This probably explained a negative development in the experienced effectiveness of supervision. It is concluded that organizational support is an imperative for implementation of clinical supervision.
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de Graaf, Nastasja M; Cohen-Kettenis, Peggy T; Carmichael, Polly; de Vries, Annelou L C; Dhondt, Karlien; Laridaen, Jolien; Pauli, Dagmar; Ball, Juliane; Steensma, Thomas D
2018-07-01
Adolescents seeking professional help with their gender identity development often present with psychological difficulties. Existing literature on psychological functioning of gender diverse young people is limited and mostly bound to national chart reviews. This study examined the prevalence of psychological functioning and peer relationship problems in adolescents across four European specialist gender services (The Netherlands, Belgium, the UK, and Switzerland), using the Child Behavioural Checklist (CBCL) and the Youth Self-Report (YSR). Differences in psychological functioning and peer relationships were found in gender diverse adolescents across Europe. Overall, emotional and behavioural problems and peer relationship problems were most prevalent in adolescents from the UK, followed by Switzerland and Belgium. The least behavioural and emotional problems and peer relationship problems were reported by adolescents from The Netherlands. Across the four clinics, a similar pattern of gender differences was found. Birth-assigned girls showed more behavioural problems and externalising problems in the clinical range, as reported by their parents. According to self-report, internalising problems in the clinical range were more prevalent in adolescent birth-assigned boys. More research is needed to gain a better understanding of the difference in clinical presentations in gender diverse adolescents and to investigate what contextual factors that may contribute to this.
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Doi, Yuriko
2016-01-01
Evidence-based medicine (EBM) is fundamental to ensuring high-quality medical care. It requires systematic reviews and meta-analyses to synthesize diverse information available from individual clinical studies. However, the literature reviewed may represent an incomplete and selective set of research findings, which could lead to publication/reporting biases and distort the true picture of research as a whole. Prospective registry of all clinical trials in the world is mandatory to reduce the biases, which have been disclosed on the International Clinical Trials Registry Platform (ICTRP) of the World Health Organization (WHO) since 2007. The Japan Primary Registries Network (JPRN) is included in the ICTRP. ClinicalTrials.gov, the U.S. clinical trial registry, reports the standardized data of registered trials and offers access to submitted outcomes online. However, the JPRN does not systematically include the outcomes. On April 14, 2015, the WHO published a new statement online on the public disclosure of clinical trial results, which requires researchers to define the timeframes of reporting main findings and key outcomes, to call for results-reporting older, but still unpublished trials, and to outline steps to improve linkages between clinical trial registry entries and their published results. The WHO's new position will facilitate global efforts to reduce publication/reporting biases in clinical trials. Japan will have to actively participate in these efforts as well.
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Aarts, Nikkie; Noordam, Raymond; Hofman, Albert; Tiemeier, Henning; Stricker, Bruno H; Visser, Loes E
2016-10-01
Background Population-based studies investigating indications for antidepressant prescribing mostly rely on diagnoses from general practitioners. However, diagnostic codes might be incomplete and drugs may be prescribed 'off-label' for indications not investigated in clinical trials. Objective We aimed to study indications for antidepressant use based on self-report. Also, we studied the presence of depressive symptoms associated with the self-reported indications. Setting Our study population of antidepressant users was selected based on interview data between 1997 and 2013 from the prospective population-based Rotterdam Study cohort (age >45 years). Method Antidepressant use, self-reported indication for use, and presence of depressive symptoms (Center for Epidemiological Studies Depression Scale) were based on interview. Self-reported indications were categorized by the researchers into officially approved, clinically-accepted and commonly mentioned off-label indications. Main outcome measures A score of 16 and higher on the Center for Epidemiological Studies Depression Scale was considered as indicator for clinically-relevant depressive symptoms. Results The majority of 914 antidepressant users reported 'depression' (52.4 %) as indication for treatment. Furthermore, anxiety, stress and sleep disorders were reported in selective serotonin reuptake inhibitor and other antidepressant users (ranging from 5.9 to 13.3 %). The indication 'pain' was commonly mentioned by tricyclic antidepressant users (19.0 %). Indications were statistically significantly associated with higher depressive symptom scores when compared to non-users (n = 10,979). Conclusions Depression was the main indication for antidepressant treatment. However, our findings suggest that antidepressants are also used for off-label indications, subthreshold disorders and complex situations, which were all associated with clinically-relevant depressive symptoms in the middle-aged and elderly population.
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Autochthonous canine leishmaniasis in Romania: neglected or (re)emerging?
2014-01-01
Canine leishmaniasis is a vector-borne zoonotic disease caused by the protozoan parasite Leishmania infantum. In Romania between 1955 and 2013, no cases of human autochthonous visceral leishmaniasis were reported. Data regarding canine leishmaniasis is similarly scarce. Since the first report of clinical autochthonous canine leishmaniasis in 1935, there were only three sporadic reports of positive dogs all without any clinical signs. Our study reports the first clinical case of autochthonous canine leishmaniasis in the last 80 years, stressing the importance of a targeted surveillance of Leishmania infection, as infected dogs act as the primary reservoir for zoonotic visceral leishmaniasis. PMID:24684827
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Motte, Anne-France; Diallo, Stéphanie; van den Brink, Hélène; Châteauvieux, Constance; Serrano, Carole; Naud, Carole; Steelandt, Julie; Alsac, Jean-Marc; Aubry, Pierre; Cour, Florence; Pellerin, Olivier; Pineau, Judith; Prognon, Patrice; Borget, Isabelle; Bonan, Brigitte; Martelli, Nicolas
2017-11-01
The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices (IMDs) and to identify reporting guidelines which include these items. A panel of experts identified the most relevant items for evaluating IMDs from an initial list based on reference papers. We then conducted a systematic review of articles indexed in MEDLINE. We retrieved reporting guidelines from the EQUATOR network's library for health research reporting. Finally, we screened these reporting guidelines to find those using our set of reporting items. Seven relevant reporting items were selected that related to four topics: randomization, learning curve, surgical setting, and device information. A total of 348 reporting guidelines were identified, among which 26 met our inclusion criteria. However, none of the 26 reporting guidelines presented all seven items together. The most frequently reported item was timing of randomization (65%). On the contrary, device information and learning curve effects were poorly specified. To our knowledge, this study is the first to identify specific items related to IMDs in reporting guidelines for clinical trials. We have shown that no existing reporting guideline is totally suitable for these devices. Copyright © 2017 Elsevier Inc. All rights reserved.
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More than the money: A review of the literature examining healthy volunteer motivations
Stunkel, Leanne; Grady, Christine
2016-01-01
Background and Objective Few existing data report the motivations of healthy volunteers in clinical research trials. Some worry that volunteers consider only financial motivations. This study summarized and analyzed existing empirical research on self-reported motivations of healthy volunteers participating in studies not intended to offer benefit from participation. Study Selection A systematic PubMed search was conducted. Inclusion criteria captured English-language empirical studies on the self-reported motivations, reasons, or factors influencing the decision of healthy volunteers to enroll in clinical research. Twelve studies involving more than 2000 healthy volunteers met the criteria and were included in this review. Data Extraction Independent review by the authors and extraction of information about the sample, methodology and objective of the motivations study, description of the clinical trial and whether participation was actual or hypothetical, reported primary and secondary motivations of the healthy volunteers, risk evaluation, and reported differences in motivations related to sociodemographic variables. Results This review showed that although financial reward is the primary motivation for healthy volunteers to participate in clinical trials, financial motivations are one among many other reported motivations, including contributing to science or the health of others, accessing ancillary healthcare benefits, scientific interest or interest in the goals of the study, as well as meeting people and curiosity. Volunteers consider risk when making a decision about participation. Conclusions Although financial incentives are important in recruiting healthy volunteers, their motivations are not limited to financial motivations. Further research is needed to examine motivations in different contexts and countries, the decision making of healthy volunteers, and the dynamics of repeat participation. PMID:21146635
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Berge, Jerica M.; Law, David D.; Johnson, Jennifer; Wells, M. Gawain
2013-01-01
Background Although integrated care for adults in primary care has steadily increased over the last several decades, there remains a paucity of research regarding integrated care for children in primary care. Purpose To report results of a pilot study testing initial feasibility of a parenting psychoeducational group targeting child behavioral problems within a primary care clinic. Method The participants (n = 35) were parents representing an underserved population from an inner-city primary care clinic. Participants attended a 12-week psychoeducational parenting group and reported pre- and post-measures of family functioning, child misbehavior and dyadic functioning. Paired t-tests and effects sizes are reported. Results Participants reported statistically significant improvement in family functioning, child misbehavior and couple functioning after participating in the parenting psychoeducational group. Conclusions Results suggest initial feasibility of a parenting psychoeducational group within a primary care clinic with an underserved population. This intervention may be useful for other primary care clinics seeking to offer more integrative care options for children and their families. PMID:20939627
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Clinician’s use of automated reports of estimated glomerular filtration rate: A qualitative study
2012-01-01
Background There is a growing awareness in primary care of the importance of identifying patients with chronic kidney disease (CKD) so that they can receive appropriate clinical care; one method that has been widely embraced is the use of automated reporting of estimated glomerular filtration rate (eGFR) by clinical laboratories. We undertook a qualitative study to examine how clinicians use eGFR in clinical decision making, patient communication issues, barriers to use of eGFR, and suggestions to improve the clinical usefulness of eGFR reports. Methods Our study used qualitative methods with structured interviews among primary care clinicians including both physicians and allied health providers, recruited from Kaiser Permanente Northwest, a non-profit health maintenance organization. Results We found that clinicians generally held favorable views toward eGFR reporting but did not use eGFR to replace serum creatinine in their clinical decision-making. Clinicians used eGFR as a tool to help identify CKD, educate patients about their kidney function and make treatment decisions. Barriers noted by several clinicians included a desire for greater education regarding care for patients with CKD and tools to facilitate discussion of eGFR findings with patients. Conclusions The manner in which clinicians use eGFRs appears to be more complex than previously understood, and our study illustrates some of the efforts that might be usefully undertaken (e.g. specific clinician education) when encouraging further promulgation of eGFR reporting and usage. PMID:23173944
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Regner, Gabriela G.; Pereira, Patrícia; Leffa, Douglas T.; de Oliveira, Carla; Vercelino, Rafael; Fregni, Felipe; Torres, Iraci L. S.
2018-01-01
Epilepsy is a chronic brain syndrome characterized by recurrent seizures resulting from excessive neuronal discharges. Despite the development of various new antiepileptic drugs, many patients are refractory to treatment and report side effects. Non-invasive methods of brain stimulation, such as transcranial direct current stimulation (tDCS), have been tested as alternative approaches to directly modulate the excitability of epileptogenic neural circuits. Although some pilot and initial clinical studies have shown positive results, there is still uncertainty regarding the next steps of investigation in this field. Therefore, we reviewed preclinical and clinical studies using the following framework: (1) preclinical studies that have been successfully translated to clinical studies, (2) preclinical studies that have failed to be translated to clinical studies, and (3) clinical findings that were not previously tested in preclinical studies. We searched PubMed, Web of Science, Embase, and SciELO (2002–2017) using the keywords “tDCS,” “epilepsy,” “clinical trials,” and “animal models.” Our initial search resulted in 64 articles. After applying inclusion and exclusion criteria, we screened 17 full-text articles to extract findings about the efficacy of tDCS, with respect to the therapeutic framework used and the resulting reduction in seizures and epileptiform patterns. We found that few preclinical findings have been translated into clinical research (number of sessions and effects on seizure frequency) and that most findings have not been tested clinically (effects of tDCS on status epilepticus and absence epilepsy, neuroprotective effects in the hippocampus, and combined use with specific medications). Finally, considering that clinical studies on tDCS have been conducted for several epileptic syndromes, most were not previously tested in preclinical studies (Rasmussen's encephalitis, drug resistant epilepsy, and hippocampal sclerosis-induced epilepsy). Overall, most studies report positive findings. However, it is important to underscore that a successful preclinical study may not indicate success in a clinical study, considering the differences highlighted herein. Although most studies report significant findings, there are still important insights from preclinical work that must be tested clinically. Understanding these factors may improve the evidence for the potential use of this technique as a clinical tool in the treatment of epilepsy. PMID:29623027
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Gender issues in clinical dental education.
Tiwana, Karen K; Kutcher, Mark J; Phillips, Ceib; Stein, Margot; Oliver, Jessica
2014-03-01
In spring 2011, a study was initiated to investigate the nature and extent of gender issues in clinical dental education at the University of North Carolina at Chapel Hill School of Dentistry. Surveys were sent to 236 dental students in the second, third, and fourth years; eighty-six (36.4 percent) responded. Surveys were also sent to seventy-one full-time dental faculty members who had clinical contact with students, and thirty-four (47.9 percent) responded. Of the student respondents, fifty-one were female and thirty-five were male; the faculty respondents were ten women and twenty-four men. A significantly greater proportion of female than male student respondents reported that issues related to gender affected clinical training. The female students also responded that mentorship was less available and less in content for them compared to males, and significantly more female than male students reported lower self-confidence in clinical settings. Among faculty respondents, a higher proportion of women than men reported insufficient awareness of gender issues. These faculty members also reported thinking that female students showed more empathy toward patients than males. Both faculty and student respondents said that female faculty members received less respect from students than did male faculty members. Forty-eight percent of the students reported experiencing or witnessing gender-based prejudice in clinical settings, and 7.0 percent reported experiencing or witnessing unwelcome sexual advances or conduct. A more robust study to include other dental institutions is needed. With confirmation of specific gender issues, corrective measures could be recommended to improve the climate for both females and males in the clinical component of dental education.
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Polansky, Hanan; Javaherian, Adrian; Itzkovitz, Edan
2016-01-01
This paper reports the results of a clinical study that tested the effect of suppressive treatment with the botanical product Gene-Eden-VIR/Novirin on the number of genital herpes outbreaks. The results in this study were compared to those published in clinical studies of acyclovir, valacyclovir, and famciclovir. The framework was a retrospective chart review. The population included 139 participants. The treatment was one to four capsules of Gene-Eden-VIR/Novirin per day. The duration of treatment was 2-48 months. The study included three controls recommended by the US Food and Drug Administration (FDA): baseline, no treatment, and dose response. The treatment decreased the number of outbreaks per year in 90.8% of the participants. The treatment also decreased the mean number of outbreaks per year from 7.27 and 5.5 in the control groups to 2.39 (P<0.0001 and P<0.001, respectively). The treated participants reported no adverse experiences. Out of the 15 tests that compared Gene-Eden-VIR/Novirin to the three drugs, Gene-Eden-VIR/Novirin had superior efficacy in eight tests, inferior efficacy in three tests, and comparable efficacy in four tests. Gene-Eden-VIR/Novirin also had superior safety. The clinical study showed that the natural Gene-Eden-VIR/Novirin decreases the number of genital herpes outbreaks without any side effects. The study also showed that the clinical effects reported in this study are mostly better than those reported in the reviewed studies of acyclovir, valacyclovir, and famciclovir.
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Clinical and experimental study of TMJ distraction: preliminary results.
Festa, F; Galluccio, G
1998-01-01
A physiotherapeutic approach, with manual maneuvers and/or distraction appliances, is indicated in the treatment of temporomandibular joint disorders (TMDs) to prevent the progressive fibrosis of the muscle fibers. In this article, the authors report preliminary results of experimental and clinical studies conducted to assess the real effect of distraction in temporomandibular joint disorders. The experimental invivo studies confirmed the structural alteration due to compression and distraction on the capsular and condylar tissues. Clinical cases are reported to show the increase of the intraarticular vertical dimension, with a forward and downward movement of the condyles in a more physiologic condition.
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Block versus longitudinal integrated clerkships: students' views of rural clinical supervision.
Witney, Martin; Isaac, Vivian; Playford, Denese; Walker, Leesa; Garne, David; Walters, Lucie
2018-07-01
Medical students undertaking longitudinal integrated clerkships (LICs) train in multiple disciplines concurrently, compared with students in block rotations who typically address one medical discipline at a time. Current research suggests that LICs afford students increased access to patients and continuity of clinical supervision. However, these factors are less of an issue in rural placements where there are fewer learners. The aim of this study was to compare rural LIC and rural block rotation students' reported experiences of clinical supervision. De-identified data from the 2015 version of the Australian national rural clinical schools (RCSs) exit survey was used to compare students in LICs with those in block rotations in relation to how they evaluate their clinical supervisors and how they rate their own clinical competence. Multivariate general linear modelling showed no association between placement type (LIC versus Block) and reported clinical supervision. The single independent predictor of positive perception of clinical supervisors was choosing an RCS as a first preference. There was also no association between placement type (LIC versus Block) and self-rated clinical competence. Instead, the clinical supervision score and male gender predicted more positive self-ratings of clinical competence. The quality of clinical supervision in block placements and LIC programmes in rural Australian settings was reported by students as equivalent. © 2018 John Wiley & Sons Ltd and The Association for the Study of Medical Education.
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Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia
2018-01-01
Objective To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. Methods We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Results Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. Conclusions The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future. PMID:29872509
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Haas, Marion; Viney, Rosalie; Pearson, Sallie-Anne; Haywood, Philip; Brown, Chris; Ward, Robyn
2017-01-01
Aim Chemotherapy side effects are often reported in clinical trials; however, there is little evidence about their incidence in routine clinical care. The objective of this study was to describe the frequency and severity of patient-reported chemotherapy side effects in routine care across treatment centres in Australia. Methods We conducted a prospective cohort study of individuals with breast, lung or colorectal cancer undergoing chemotherapy. Side effects were identified by patient self-report. The frequency, prevalence and incidence rates of side effects were calculated by cancer type and grade, and cumulative incidence curves for each side effect computed. Frequencies of side effects were compared between demographic subgroups using chi-squared statistics. Results Side effect data were available for 449 eligible individuals, who had a median follow-up of 5.64 months. 86% of participants reported at least one side effect during the study period and 27% reported a grade IV side effect, most commonly fatigue or dyspnoea. Fatigue was the most common side effect overall (85%), followed by diarrhoea (74%) and constipation (74%). Prevalence and incidence rates were similar across side effects and cancer types. Age was the only demographic factor associated with the incidence of side effects, with older people less likely to report side effects. Conclusion This research has produced the first Australian estimates of self-reported incidence of chemotherapy side effects in routine clinical care. Chemotherapy side effects in routine care are common, continue throughout chemotherapy and can be serious. This work confirms the importance of observational data in providing clinical practice-relevant information to decision-makers. PMID:29016607
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Pearce, Alison; Haas, Marion; Viney, Rosalie; Pearson, Sallie-Anne; Haywood, Philip; Brown, Chris; Ward, Robyn
2017-01-01
Chemotherapy side effects are often reported in clinical trials; however, there is little evidence about their incidence in routine clinical care. The objective of this study was to describe the frequency and severity of patient-reported chemotherapy side effects in routine care across treatment centres in Australia. We conducted a prospective cohort study of individuals with breast, lung or colorectal cancer undergoing chemotherapy. Side effects were identified by patient self-report. The frequency, prevalence and incidence rates of side effects were calculated by cancer type and grade, and cumulative incidence curves for each side effect computed. Frequencies of side effects were compared between demographic subgroups using chi-squared statistics. Side effect data were available for 449 eligible individuals, who had a median follow-up of 5.64 months. 86% of participants reported at least one side effect during the study period and 27% reported a grade IV side effect, most commonly fatigue or dyspnoea. Fatigue was the most common side effect overall (85%), followed by diarrhoea (74%) and constipation (74%). Prevalence and incidence rates were similar across side effects and cancer types. Age was the only demographic factor associated with the incidence of side effects, with older people less likely to report side effects. This research has produced the first Australian estimates of self-reported incidence of chemotherapy side effects in routine clinical care. Chemotherapy side effects in routine care are common, continue throughout chemotherapy and can be serious. This work confirms the importance of observational data in providing clinical practice-relevant information to decision-makers.
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Callens, Bénédicte F; Haesebrouck, Freddy; Maes, Dominiek; Butaye, Patrick; Dewulf, Jeroen; Boyen, Filip
2013-04-01
Streptococcus suis (S. suis) has often been reported as an important swine pathogen and is considered as a new emerging zoonotic agent. Consequently, it is important to be informed on its susceptibility to antimicrobial agents. In the current study, the Minimum Inhibitory Concentration (MIC) population distribution of nine antimicrobial agents has been determined for nasal S. suis strains, isolated from healthy pigs at the end of the fattening period from 50 closed or semiclosed pig herds. The aim of the study was to report resistance based on both clinical breakpoints (clinical resistance percentage) and epidemiological cutoff values (non-wild-type percentage). Non-wild-type percentages were high for tetracycline (98%), lincomycin (92%), tilmicosin (72%), erythromycin (70%), tylosin (66%), and low for florfenicol (0%) and enrofloxacin (0.3%). Clinical resistance percentages were high for tetracycline (95%), erythromycin (66%), tylosin (66%), and low for florfenicol (0.3%) and enrofloxacin (0.3%). For tiamulin, for which no clinical breakpoint is available, 57% of the isolates did not belong to the wild-type population. Clinical resistance and non-wild-type percentages differed substantially for penicillin. Only 1% of the tested S. suis strains was considered as clinically resistant, whereas 47% of the strains showed acquired resistance when epidemiological cutoff values were used. In conclusion, MIC values for penicillin are gradually increasing, compared to previous reports, although pigs infected with strains showing higher MICs may still respond to treatment with penicillin. The high rate of acquired resistance against tiamulin has not been reported before. Results from this study clearly demonstrate that the use of different interpretive criteria contributes to the extent of differences in reported antimicrobial resistance results. The early detection of small changes in the MIC population distribution of isolates, while clinical failure may not yet be observed, provides the opportunity to implement appropriate risk management steps.
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Establishing Maximal Medical Improvement After Arthroscopic Rotator Cuff Repair.
Zuke, William A; Leroux, Timothy S; Gregory, Bonnie P; Black, Austin; Forsythe, Brian; Romeo, Anthony A; Verma, Nikhil N
2018-03-01
As health care transitions from a pay-for-service to a pay-for-performance infrastructure, the value of orthopaedic care must be defined accurately. Significant efforts have been made in defining quality and cost in arthroplasty; however, there remains a lag in ambulatory orthopaedic care. Two-year follow-up has been a general requirement for reporting outcomes after rotator cuff repair. However, this time requirement has not been established scientifically and is of increasing importance in the era of value-based health care. Given that arthroscopic rotator cuff repair is a common ambulatory orthopaedic procedure, the purpose of this study was to establish a time frame for maximal medical improvement (the state when improvement has stabilized) after arthroscopic rotator cuff repair. Systematic review. A systematic review of the literature was conducted, identifying studies reporting sequential patient-reported outcomes up to a minimum of 2 years after arthroscopic rotator cuff repair. The primary clinical outcome was patient-reported outcomes at 3-month, 6-month, 1-year, and 2-year follow-up. Secondary clinical outcomes included range of motion, strength, retears, and complications. Clinically significant improvement was determined between various time intervals by use of the minimal clinically important difference. The review included 19 studies including 1370 patients who underwent rotator cuff repair. Clinically significant improvement in patient-reported outcomes was seen up to 1 year after rotator cuff repair, but no clinical significance was noted from 1 year to 2 years. The majority of improvement in strength and range of motion was seen up to 6 months, but no clinically meaningful improvement was seen thereafter. All reported complications and the majority of retears occurred within 6 months after rotator cuff repair. After rotator cuff repair, a clinically significant improvement in patient-reported outcomes, range of motion, and strength was seen up to 1 year after surgery, but not beyond this. This information is important not only to establish appropriate patient expectations but also to determine a time frame for outcome collection after surgery to better define value in orthopaedic care.
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Kosa, Sarah Daisy; Mbuagbaw, Lawrence; Borg Debono, Victoria; Bhandari, Mohit; Dennis, Brittany B; Ene, Gabrielle; Leenus, Alvin; Shi, Daniel; Thabane, Michael; Valvasori, Sara; Vanniyasingam, Thuva; Ye, Chenglin; Yranon, Elgene; Zhang, Shiyuan; Thabane, Lehana
2018-02-01
The primary objective of this systematic survey was to examine the percentage of studies in which there was agreement in the reporting of the primary outcome between the currently updated version of the clinical trial registry and the published paper. We also investigated the factors associated with agreement in reporting of the primary outcome. We searched PubMed for all randomized control trials (RCT)s published in 2012-2015 in the top five general medicine journals (based on the 2014 impact factor). Two hundred abstracts (50 from each year) were randomly selected for data extraction. Agreement in reporting of 11 key study conduct items (e.g., sample size) and study characteristics (e.g., funding, number of sites) were extracted by two independent reviewers. Descriptive analyses were conducted to determine the proportion of studies on which there was agreement in reporting of key study conduct items. Generalized estimating equations were used to explore factors associated with agreement in reporting of the primary outcome. Of the 200 included studies, 87% had agreement in reporting of the primary outcome. After adjusting for other covariates, having greater than 50 sites was associated with an increased likelihood of agreement in reporting of the primary outcome (odds ratio=7.1, 95% confidence interval=1.39, 36.27, p=0.018). We identified substantive disagreement in reporting between publications and current clinical trial registry, which were associated with several study characteristics. Further measures are needed to improve reporting given the potential threats to the quality and integrity of scientific research. Copyright © 2017 Elsevier Inc. All rights reserved.
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Tripp, Dean A; Nickel, J Curtis; Katz, Laura; Krsmanovic, Adrijana; Ware, Mark A; Santor, Darcy
2014-11-01
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a chronic pelvic pain condition largely refractory to treatment. Cannabis (marijuana) use has been reported for a wide variety of chronic pain conditions, but no study has examined prevalence of cannabis use, symptom benefit or side effects, or frequency in CP/CPPS. Participants were recruited from an outpatient CP/CPPS urology clinic (n = 98) and online through the Prostatitis Foundation website (n = 244). Participants completed questionnaires (demographics, CP/CPPS, depression, cannabis). The clinic sample included Canadian patients and the online sample included primarily American patients. Due to differences, groups were examined separately. Almost 50% of respondents reported using cannabis (clinic n = 49; online n = 89). Of the cannabis users, 36.8% of clinic and 75% of online respondents reported that it improved their symptoms. Most of the respondents (from the clinic and online groups) reported that cannabis improved their mood, pain, muscle spasms, and sleep. However, they did not note any improvements for weakness, fatigue, numbness, ambulation, and urination. Overall, the effectiveness of cannabis for CP/CPPS was "somewhat/very effective" (57% clinic; 63% online). There were no differences between side effects or choice of consumption and most reported using cannabis rarely. These are the first estimates in men suffering from CP/CPPS and suggest that while cannabis use is prevalent, its medical use and benefit are unknown. This is an understudied area and the benefit or hazard for cannabis use awaits further study.
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Samsiah, A.; Othman, Noordin; Jamshed, Shazia; Hassali, Mohamed Azmi
2016-01-01
Objective To explore and understand participants’ perceptions and attitudes towards the reporting of medication errors (MEs). Methods A qualitative study using in-depth interviews of 31 healthcare practitioners from nine publicly funded, primary care clinics in three states in peninsular Malaysia was conducted for this study. The participants included family medicine specialists, doctors, pharmacists, pharmacist assistants, nurses and assistant medical officers. The interviews were audiotaped and transcribed verbatim. Analysis of the data was guided by the framework approach. Results Six themes and 28 codes were identified. Despite the availability of a reporting system, most of the participants agreed that MEs were underreported. The nature of the error plays an important role in determining the reporting. The reporting system, organisational factors, provider factors, reporter’s burden and benefit of reporting also were identified. Conclusions Healthcare practitioners in primary care clinics understood the importance of reporting MEs to improve patient safety. Their perceptions and attitudes towards reporting of MEs were influenced by many factors which affect the decision-making process of whether or not to report. Although the process is complex, it primarily is determined by the severity of the outcome of the errors. The participants voluntarily report the errors if they are familiar with the reporting system, what error to report, when to report and what form to use. PMID:27906960
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de SOUZA, Raphael Freitas; CHAVES, Carolina de Andrade Lima; CHAVES, Carolina de Andrade Lima; CHAVES, Carolina de Andrade Lima; NASSER, Mona; FEDOROWICZ, Zbys
2010-01-01
Open access publishing is becoming increasingly popular within the biomedical sciences. SciELO, the Scientific Electronic Library Online, is a digital library covering a selected collection of Brazilian scientific journals many of which provide open access to full-text articles. This library includes a number of dental journals some of which may include reports of clinical trials in English, Portuguese and/or Spanish. Thus, SciELO could play an important role as a source of evidence for dental healthcare interventions especially if it yields a sizeable number of high quality reports. Objective The aim of this study was to identify reports of clinical trials by handsearching of dental journals that are accessible through SciELO, and to assess the overall quality of these reports. Material and methods Electronic versions of six Brazilian dental Journals indexed in SciELO were handsearched at www.scielo.br in September 2008. Reports of clinical trials were identified and classified as controlled clinical trials (CCTs - prospective, experimental studies comparing 2 or more healthcare interventions in human beings) or randomized controlled trials (RCTs - a random allocation method is clearly reported), according to Cochrane eligibility criteria. Criteria to assess methodological quality included: method of randomization, concealment of treatment allocation, blinded outcome assessment, handling of withdrawals and losses and whether an intention-totreat analysis had been carried out. Results The search retrieved 33 CCTs and 43 RCTs. A majority of the reports provided no description of either the method of randomization (75.3%) or concealment of the allocation sequence (84.2%). Participants and outcome assessors were reported as blinded in only 31.2% of the reports. Withdrawals and losses were only clearly described in 6.5% of the reports and none mentioned an intention-totreat analysis or any similar procedure. Conclusions The results of this study indicate that a substantial number of reports of trials and systematic reviews are available in the dental journals listed in SciELO, and that these could provide valuable evidence for clinical decision making. However, it is clear that the quality of a number of these reports is of some concern and that improvement in the conduct and reporting of these trials could be achieved if authors adhered to internationally accepted guidelines, e.g. the CONSORT statement. PMID:20485919
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de Souza, Raphael Freitas; Chaves, Carolina de Andrade Lima; Nasser, Mona; Fedorowicz, Zbys
2010-01-01
Open access publishing is becoming increasingly popular within the biomedical sciences. SciELO, the Scientific Electronic Library Online, is a digital library covering a selected collection of Brazilian scientific journals many of which provide open access to full-text articles.This library includes a number of dental journals some of which may include reports of clinical trials in English, Portuguese and/or Spanish. Thus, SciELO could play an important role as a source of evidence for dental healthcare interventions especially if it yields a sizeable number of high quality reports. The aim of this study was to identify reports of clinical trials by handsearching of dental journals that are accessible through SciELO, and to assess the overall quality of these reports. Electronic versions of six Brazilian dental Journals indexed in SciELO were handsearched at www.scielo.br in September 2008. Reports of clinical trials were identified and classified as controlled clinical trials (CCTs - prospective, experimental studies comparing 2 or more healthcare interventions in human beings) or randomized controlled trials (RCTs - a random allocation method is clearly reported), according to Cochrane eligibility criteria. CRITERIA TO ASSESS METHODOLOGICAL QUALITY INCLUDED: method of randomization, concealment of treatment allocation, blinded outcome assessment, handling of withdrawals and losses and whether an intention-to-treat analysis had been carried out. The search retrieved 33 CCTs and 43 RCTs. A majority of the reports provided no description of either the method of randomization (75.3%) or concealment of the allocation sequence (84.2%). Participants and outcome assessors were reported as blinded in only 31.2% of the reports. Withdrawals and losses were only clearly described in 6.5% of the reports and none mentioned an intention-to-treat analysis or any similar procedure. The results of this study indicate that a substantial number of reports of trials and systematic reviews are available in the dental journals listed in SciELO, and that these could provide valuable evidence for clinical decision making. However, it is clear that the quality of a number of these reports is of some concern and that improvement in the conduct and reporting of these trials could be achieved if authors adhered to internationally accepted guidelines, e.g. the CONSORT statement.
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Clinical instruments: reliability and validity critical appraisal.
Brink, Yolandi; Louw, Quinette A
2012-12-01
RATIONALE, AIM AND OBJECTIVES: There is a lack of health care practitioners using objective clinical tools with sound psychometric properties. There is also a need for researchers to improve their reporting of the validity and reliability results of these clinical tools. Therefore, to promote the use of valid and reliable tools or tests for clinical evaluation, this paper reports on the development of a critical appraisal tool to assess the psychometric properties of objective clinical tools. A five-step process was followed to develop the new critical appraisal tool: (1) preliminary conceptual decisions; (2) defining key concepts; (3) item generation; (4) assessment of face validity; and (5) formulation of the final tool. The new critical appraisal tool consists of 13 items, of which five items relate to both validity and reliability studies, four items to validity studies only and four items to reliability studies. The 13 items could be scored as 'yes', 'no' or 'not applicable'. This critical appraisal tool will aid both the health care practitioner to critically appraise the relevant literature and researchers to improve the quality of reporting of the validity and reliability of objective clinical tools. © 2011 Blackwell Publishing Ltd.
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Cahan, Amos; Anand, Vibha
2017-01-01
ClinicalTrials.gov is valuable for aggregate-level analysis of trials. The recently published final rule aims to improve reporting of trial results. We aimed to assess variability in ClinicalTirals.gov records reporting participants' baseline measures. The September 2015 edition of the database for Aggregate Analysis of ClinicalTrials.gov (AACT), was used in this study. To date, AACT contains 186,941 trials of which 16,660 trials reporting baseline (participant) measures were analyzed. We also analyzed a subset of 13,818 Highly Likely Applicable Clinical Trials (HLACT), for which reporting of results is likely mandatory and compared a random sample of 30 trial records to their journal articles. We report counts for each mandatory baseline measure and variability reporting in their formats. The AACT dataset contains 8,161 baseline measures with 1206 unique measurement units. However, of these 6,940 (85%) variables appear only once in the dataset. Age and Gender are reported using many different formats (178 and 49 respectively). "Age" as the variable name is reported in 60 different formats. HLACT subset reports measures using 3,931 variables. The most frequent Age format (i.e. mean (years) ± sd) is found in only 45% of trials. Overall only 4 baseline measures (Region of Enrollment, Age, Number of Participants, and Gender) are reported by > 10% of trials. Discrepancies are found in both the types and formats of ClinicalTrials.gov records and their corresponding journal articles. On average, journal articles include twice the number of baseline measures (13.6±7.1 (sd) vs. 6.6±7.6) when compared to the ClinicalTrials.gov records that report any results. We found marked variability in baseline measures reporting. This is not addressed by the final rule. To support secondary use of ClinicalTrials.gov, a uniform format for baseline measures reporting is warranted.
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2016-01-01
Purpose To investigate the relationship between two distinct measures of disability: self-reported functional limitations and objectively-screened clinical impairments. Methods We undertook an all age population-based survey of disability in two areas: North-West Cameroon (August/October 2013) and Telangana State, India (Feb/April 2014). Participants were selected for inclusion via two-stage cluster randomised sampling (probability proportionate to size cluster selection and compact segment sampling within clusters). Disability was defined as the presence of self-reported functional limitations across eight domains, or presence of moderate or greater clinical impairments. Clinical impairment screening comprised of visual acuity testing for vision impairment, pure tone audiometry for hearing impairment, musculoskeletal functioning assessment for musculoskeletal impairment, reported seizure history for epilepsy and reported symptoms of clinical depression (depression adults only). Information was collected using structured questionnaires, observations and examinations. Results Self-reported disability prevalence was 5.9% (95% CI 4.7–7.4) and 7.5% (5.9–9.4) in Cameroon and India respectively. The prevalence of moderate or greater clinical impairments in the same populations were 8.4% (7.5–9.4) in Cameroon and 10.5% (9.4–11.7) in India. Overall disability prevalence (self-report and/or screened positive to a moderate or greater clinical impairment) was 10.5% in Cameroon and 12.2% in India, with limited overlap between the sub-populations identified using the two types of tools. 33% of participants in Cameroon identified to have a disability, and 45% in India, both reported functional limitations and screened positive to objectively-screened impairments, whilst the remainder were identified via one or other tool only. A large proportion of people with moderate or severe clinical impairments did not self-report functional difficulties despite reporting participation restrictions. Conclusion Tools to assess reported functional limitation alone are insufficient to identify all persons with participation restrictions and moderate or severe clinical impairments. A self-reported functional limitation tool followed by clinical screening of all those who report any level of difficulty would identify 94% of people with disabilities in Cameroon and 95% in India, meeting the study criteria. PMID:27741320
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Mactaggart, Islay; Kuper, Hannah; Murthy, G V S; Oye, Joseph; Polack, Sarah
2016-01-01
To investigate the relationship between two distinct measures of disability: self-reported functional limitations and objectively-screened clinical impairments. We undertook an all age population-based survey of disability in two areas: North-West Cameroon (August/October 2013) and Telangana State, India (Feb/April 2014). Participants were selected for inclusion via two-stage cluster randomised sampling (probability proportionate to size cluster selection and compact segment sampling within clusters). Disability was defined as the presence of self-reported functional limitations across eight domains, or presence of moderate or greater clinical impairments. Clinical impairment screening comprised of visual acuity testing for vision impairment, pure tone audiometry for hearing impairment, musculoskeletal functioning assessment for musculoskeletal impairment, reported seizure history for epilepsy and reported symptoms of clinical depression (depression adults only). Information was collected using structured questionnaires, observations and examinations. Self-reported disability prevalence was 5.9% (95% CI 4.7-7.4) and 7.5% (5.9-9.4) in Cameroon and India respectively. The prevalence of moderate or greater clinical impairments in the same populations were 8.4% (7.5-9.4) in Cameroon and 10.5% (9.4-11.7) in India. Overall disability prevalence (self-report and/or screened positive to a moderate or greater clinical impairment) was 10.5% in Cameroon and 12.2% in India, with limited overlap between the sub-populations identified using the two types of tools. 33% of participants in Cameroon identified to have a disability, and 45% in India, both reported functional limitations and screened positive to objectively-screened impairments, whilst the remainder were identified via one or other tool only. A large proportion of people with moderate or severe clinical impairments did not self-report functional difficulties despite reporting participation restrictions. Tools to assess reported functional limitation alone are insufficient to identify all persons with participation restrictions and moderate or severe clinical impairments. A self-reported functional limitation tool followed by clinical screening of all those who report any level of difficulty would identify 94% of people with disabilities in Cameroon and 95% in India, meeting the study criteria.
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PTSD, resilience and posttraumatic growth among ex-prisoners of war and combat veterans.
Zerach, Gadi; Solomon, Zahava; Cohen, Assaf; Ein-Dor, Tsachi
2013-01-01
Past studies have shown that adversity may yield various salutogenic outcomes. two constructs that have been at the center of this scientific investigation are resilience and posttraumatic growth (PTG). the present study aims to clarify the relations between posttraumatic stress symptoms, resilience and PTG among israeli war veterans. the sample includes former prisoners of war (ex-POWs) (n=103) and comparable veterans (n=106) of the 1973 Yom Kippur War. the veterans were assessed twice: 18 and 30 years after the war with self-report questionnaires. resilience, defined as the absence of posttraumatic symptoms, and PTG are negatively correlated. resilient ex- POWs and veterans reported the lowest levels of PTG when compared to participants diagnosed with clinical and sub-clinical posttraumatic stress disorder (PtSd). Furthermore, PTG dimensions were found to be the most differentiating factor between study groups, followed by war exposure measures and clinical reports of depression and anxiety symptoms. this study strengthens the understanding that combatants who report high-level PtSd symptoms also report higher levels of positive psychological changes in the face of severe adversity.
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Tsai, Peng-Chou; Harrington, Rebecca A; Lung, For-Wey; Lee, Li-Ching
2017-07-01
The Social Communication Questionnaire is one of the most commonly used screening tools for autism spectrum disorder. The Social Communication Questionnaire is a caregiver-reported questionnaire with 40 items based on questions from the Autism Diagnostic Interview-Revised. This study collected Social Communication Questionnaire data from a community-based, multi-stage case identification design epidemiologic study in one socioeconomically disadvantaged county in Taiwan. The Social Communication Questionnaire was distributed to 3034 school children, aged 6-8 years. Item prevalence results indicate males were reported to have more autism-related behaviors than females (higher prevalence on most items), in the whole study sample as well as in children meeting Social Communication Questionnaire clinical cut-offs (⩾15). Children whose biological fathers completed the Social Communication Questionnaire were reported to have more behavioral issues than children whose biological mothers were the respondent. Lower respondent education levels were associated with reports of clinically concerning autism-related behaviors. However, males were not at higher risk of meeting Social Communication Questionnaire clinical cut-offs than females in this study population. Findings from this study help to better understand reporting patterns on children's autism-related behaviors potentially due to social demographic characteristics and child sex, which may lead to improved identification of these behaviors.
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McBee, Morgan P; Laor, Tal; Pryor, Rebecca M; Smith, Rachel; Hardin, Judy; Ulland, Lisa; May, Sally; Zhang, Bin; Towbin, Alexander J
2018-02-01
The purpose of this study was to adapt our radiology reports to provide the documentation required for specific International Classification of Diseases, tenth rev (ICD-10) diagnosis coding. Baseline data were analyzed to identify the reports with the greatest number of unspecified ICD-10 codes assigned by computer-assisted coding software. A two-part quality improvement initiative was subsequently implemented. The first component involved improving clinical histories by utilizing technologists to obtain information directly from the patients or caregivers, which was then imported into the radiologist's report within the speech recognition software. The second component involved standardization of report terminology and creation of four different structured report templates to determine which yielded the fewest reports with an unspecified ICD-10 code assigned by an automated coding engine. In all, 12,077 reports were included in the baseline analysis. Of these, 5,151 (43%) had an unspecified ICD-10 code. The majority of deficient reports were for radiographs (n = 3,197; 62%). Inadequacies included insufficient clinical history provided and lack of detailed fracture descriptions. Therefore, the focus was standardizing terminology and testing different structured reports for radiographs obtained for fractures. At baseline, 58% of radiography reports contained a complete clinical history with improvement to >95% 8 months later. The total number of reports that contained an unspecified ICD-10 code improved from 43% at baseline to 27% at completion of this study (P < .0001). The number of radiology studies with a specific ICD-10 code can be improved through quality improvement methodology, specifically through the use of technologist-acquired clinical histories and structured reporting. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.
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Schneider, Barbara St Pierre; Nicholas, Jennifer; Kurrus, Jeffrey E
2013-01-01
To compare the methodologic quality and study/report characteristics between quantitative clinical nursing and nursing education research articles. The methodologic quality of quantitative nursing education research needs to advance to a higher level. Clinical research can provide guidance for nursing education to reach this level. One hundred quantitative clinical research articles from-high impact journals published in 2007 and 37 education research articles from high impact journals published in 2006 to 2007 were chosen for analysis. Clinical articles had significantly higher quality scores than education articles in three domains: number of institutions studied, type of data, and outcomes. The findings indicate three ways in which nursing education researchers can strengthen the methodologic quality of their quantitative research. With this approach, greater funding may be secured for advancing the science of nursing education.
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de Menezes, Tarciana Nobre; Oliveira, Elaine Cristina Tôrres; de Sousa Fischer, Milena Abreu Tavares
2014-02-01
Self-reported information has been used as an easy and quick method to estimate the prevalence of systemic hypertension in populations. However, verification of whether self-reports of the disease are consistent with clinical diagnosis is essential for proper use of this information. This study aimed to verify the validity and concordance between self-reported and clinical diagnosis of hypertension in the elderly population of a city in northeastern Brazil. This was a cross-sectional and population-based study. The prevalence of diagnosed and self-reported hypertension and the validity and concordance between self-reported and clinical diagnosis and their distribution according to demographic and socioeconomic variables were assessed. The validity of self-reported hypertension was determined by sensitivity, specificity, and positive and negative predictive value. Overall, 795 elderly patients were evaluated (69.1% women). There was a high prevalence of hypertension among the elderly (diagnosed: 75.1%, 95% confidence interval (CI) = 71.1%-77.9%; self-reported: 59.7%, 95% CI = 56.3%-63.1%). For self-reported hypertension, sensitivity was substantial (77.1%), specificity was excellent (93.4%), positive predictive value was excellent (97.3%), and negative predictive value was moderate (57.2%). There was a moderate concordance between self-reported and clinical diagnosis of hypertension (kappa = 0.59; P < 0.001). Reasonable validity and moderate concordance of self-reported information on hypertension was observed, which reinforces the idea that this information can be used as strategy for detecting the disease prevalence in this population. However, because of nonachievement of excellence in the validity and reliability of the measured blood pressure, this information should be carefully considered for the strategic planning of health services.
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METHODOLOGICAL QUALITY OF ECONOMIC EVALUATIONS ALONGSIDE TRIALS OF KNEE PHYSIOTHERAPY.
García-Pérez, Lidia; Linertová, Renata; Arvelo-Martín, Alejandro; Guerra-Marrero, Carolina; Martínez-Alberto, Carlos Enrique; Cuéllar-Pompa, Leticia; Escobar, Antonio; Serrano-Aguilar, Pedro
2017-01-01
The methodological quality of an economic evaluation performed alongside a clinical trial can be underestimated if the paper does not report key methodological features. This study discusses methodological assessment issues on the example of a systematic review on cost-effectiveness of physiotherapy for knee osteoarthritis. Six economic evaluation studies included in the systematic review and related clinical trials were assessed using the 10-question check-list by Drummond and the Physiotherapy Evidence Database (PEDro) scale. All economic evaluations were performed alongside a clinical trial but the studied interventions were too heterogeneous to be synthesized. Methodological quality of the economic evaluations reported in the papers was not free of drawbacks, and in some cases, it improved when information from the related clinical trial was taken into account. Economic evaluation papers dedicate little space to methodological features of related clinical trials; therefore, the methodological quality can be underestimated if evaluated separately from the trials. Future economic evaluations should follow more strictly the recommendations about methodology and the authors should pay special attention to the quality of reporting.
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Hammersmith, Kimberly J; Lee, Jessica Y
2009-01-01
Dental providers are increasingly challenged in communicating with patients with limited English proficiency (LEP). Accordingly, the purpose of the study was to examine methods of communicating with patients with LEP in North Carolina (NC) safety-net dental clinics as perceived by dental staff. An anonymous, 36-item, cross-sectional survey was distributed to representatives of 68 NC safety-net dental clinics. Question domains included: a) a perceived need for language services; b) methods of language services provided; c) perceptions of dental staff about dental care experiences for patients with LEP; and d) perceived legal and financial roles in providing language services. Of the 68 clinics, 55 responded (81 percent). All clinics reported treating patients with LEP, and 93 percent of clinics reported a need for providing language services. Many clinics used multiple methods to provide language services. Some clinics reported differences in treatment recommendations (13 percent), treatment provided (19 percent), and visit length (61 percent) for patients with LEP. All responded that additional costs are incurred to treat patients with LEP, and only 69 percent of responding clinics recognized legal obligations of treating patients with LEP. There is a reported need for language services in NC safety-net dental clinics. These services often resulted in additional costs to the dental clinic. To maintain the quality of care and to comply with legal requirements related to dental patients with LEP, additional funding sources might be required to recruit multilingual staff, support language services in dental clinics, and provide language skills training for practicing dentists. Additionally, studies are suggested to measure the perception of the effectiveness of communication methods of patients with LEP.
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Antonacci, Anthony C; Lam, Steven; Lavarias, Valentina; Homel, Peter; Eavey, Roland D
2008-12-01
To study the profile of incidents affecting quality outcomes after surgery by developing a usable operating room and perioperative clinical incident report database and a functional electronic classification, triage, and reporting system. Previously, incident reports after surgery were handled on an individual, episodic basis, which limited the ability to perceive actuarial patterns and meaningfully improve outcomes. Clinical incident reports were experientially generated in the second largest health care system in New York City. Data were entered into a functional classification system organized into 16 categories, and weekly triage meetings were held to electronically review and report summaries on 40 to 60 incident reports per week. System development and deployment reviewed 1041 reports after 19,693 operative procedures. During the next 4 years, 3819 additional reports were generated from 83,988 operative procedures and were reported electronically to the appropriate departments. Number of incident reports generated annually. A significant decrease in volume-adjusted clinical incident reports occurred (from 53 to 39 reports per 1000 procedures) from 2001 to 2005 (P < .001). Reductions in incident reports were observed for ambulatory conversions (74% reduction), wasted implants (65%), skin breakdown (64%), complications in the operating room (42%), laparoscopic conversions (32%), and cancellations (23%) as a result of data-focused process and clinical interventions. Six of 16 categories of incident reports accounted for more than 88% of all incident reports. These data suggest that effective review, communication, and summary feedback of clinical incident reports can produce a statistically significant decrease in adverse outcomes.
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Sutaria, Shailen; Philipson, Peter; Fitzpatrick, Natalie K; Abrams, Keith; Moreno, Santiago G; Timmis, Adam; Hingorani, Aroon D; Hemingway, Harry
2012-04-01
Translational phases of study are important in evaluating whether a prognostic biomarker is likely to have impact on clinical practice but systematic evaluations of such evidence are lacking. To systematically evaluate the clinical usefulness of the published literature on the association of natriuretic peptides (NP) and prognosis in stable coronary disease. MEDLINE and EMBASE until the end of July 2009, without restrictions. Prospective studies measuring NP in people with stable coronary disease who were followed-up for all cause mortality, coronary or cardiovascular events. Two independent reviewers categorised studies according to the American Heart Association phase of study, and extracted data according to the study reporting guidelines from the American Heart Association and REMARK. Systematic review of 19 studies found 17 which were phase 2, reporting an association between NP and events, two phase 3 studies, statistically examining the incremental prognostic value of NP, but no studies assessing whether NP predicted risk sufficiently to change management (phase 4), improve clinical outcomes (phase 5) or cost effectiveness (phase 6). No study referred to a statistical analytic protocol. Meta-analysis of 14 studies, reporting 18,841 patients and 1655 outcome events, found an RR for events of 3.28 (95% CI 2.45 to 4.38) comparing top versus bottom third of NP. This effect was 26% lower among the five studies which adjusted for a priori confounders (age, sex, renal function and left ventricular function) and 38% lower when adjusting for publication bias (Egger's p=0.001). The unbiased strength of association of NP with prognosis in stable coronary disease is unclear, and there is a lack of reports of clinically useful measures of prediction and discrimination or studies relating NP levels to clinical decision making. The available literature is confined to early phases and is of limited clinical usefulness.
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Clinical evidence for orphan medicinal products-a cause for concern?
Picavet, Eline; Cassiman, David; Hollak, Carla E; Maertens, Johan A; Simoens, Steven
2013-10-16
The difficulties associated with organising clinical studies for orphan medicinal products (OMPs) are plentiful. Recent debate on the long-term effectiveness of some OMPs, led us to question whether the initial standards for clinical evidence for OMPs, set by the European Medicines Agency (EMA) at the time of marketing authorization, are too low. Therefore, the aim of this study was to quantitatively evaluate the characteristics and quality of clinical evidence that is presented for OMPs to obtain marketing authorization in Europe, using the new and validated COMPASS tool. We quantitatively assessed the characteristics and quality of clinical evidence of the pivotal studies of 64 OMPs as described in the European Public Assessment Report and/or the Scientific Discussion document prepared by the Committee for Human Medicinal Products of the EMA. The 64 OMPs were altogether authorized for 78 orphan indications, for which 117 studies were identified as 'pivotal' or 'main' studies. In approximately two thirds of the studies, the allocation was randomized (64.8%) and a control arm was used (68.5%). Half of the studies applied some type of blinding. Only a minority (26.9%) of the studies included a Quality-of-Life (QoL) related endpoint, of which a third claim an improvement in QoL. Upon analyzing the quality of reporting, we found that some aspects (i.e. the endpoints, the sampling criteria, and the interventions) are well described, whereas other items (i.e. a description of the patients and of potential biases) are not reported for all studies. In conclusion, the pivotal studies that are the basis for marketing authorization of OMPs are a cause for concern, as they exhibit methodological flaws i.e. the lack of QoL-related endpoints as outcome, lack of blinding in the study design and the use of surrogate endpoints. Additionally, there are shortcomings in the reporting of those studies that complicate the interpretation. A more demanding regulatory process for OMPs is needed to guide evidence-based clinical decision-making.
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Rolfes, Leàn; van Hunsel, Florence; van der Linden, Laura; Taxis, Katja; van Puijenbroek, Eugène
2017-07-01
Clinical information is needed to assess the causal relationship between a drug and an adverse drug reaction (ADR) in a reliable way. Little is known about the level of relevant clinical information about the ADRs reported by patients. The aim was to determine to what extent patients report relevant clinical information about an ADR compared with their healthcare professional. A retrospective analysis of all ADR reports on the same case, i.e., cases with a report from both the patient and the patient's healthcare professional, selected from the database of the Dutch Pharmacovigilance Center Lareb, was conducted. The extent to which relevant clinical information was reported was assessed by trained pharmacovigilance assessors, using a structured tool. The following four domains were assessed: ADR, chronology, suspected drug, and patient characteristics. For each domain, the proportion of reported information in relation to information deemed relevant was calculated. An average score of all relevant domains was determined and categorized as poorly (≤45%), moderately (from 46 to 74%) or well (≥75%) reported. Data were analyzed using a paired sample t test and Wilcoxon signed rank test. A total of 197 cases were included. In 107 cases (54.3%), patients and healthcare professionals reported a similar level of clinical information. Statistical analysis demonstrated no overall differences between the groups (p = 0.126). In a unique study of cases of ADRs reported by patients and healthcare professionals, we found that patients report clinical information at a similar level as their healthcare professional. For an optimal pharmacovigilance, both healthcare professionals and patient should be encouraged to report.
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Scott, Frank I; McConnell, Ryan A; Lewis, Matthew E; Lewis, James D
2012-04-01
Significant advances have been made in clinical and epidemiologic research methods over the past 30 years. We sought to demonstrate the impact of these advances on published gastroenterology research from 1980 to 2010. Twenty original clinical articles were randomly selected from each of three journals from 1980, 1990, 2000, and 2010. Each article was assessed for topic, whether the outcome was clinical or physiologic, study design, sample size, number of authors and centers collaborating, reporting of various statistical methods, and external funding. From 1980 to 2010, there was a significant increase in analytic studies, clinical outcomes, number of authors per article, multicenter collaboration, sample size, and external funding. There was increased reporting of P values, confidence intervals, and power calculations, and increased use of large multicenter databases, multivariate analyses, and bioinformatics. The complexity of clinical gastroenterology and hepatology research has increased dramatically, highlighting the need for advanced training of clinical investigators.
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Patel, Ankur; Trivedi, Sangeeta S.; Chudasama, Rajesh K.; Patel, Priyanka K.
2012-01-01
Objective: To study the effect of antiretroviral therapy (ART) on clinical, immunologic, and nutritional progression of disease in human immunodeficiency virus (HIV)-infected children for 1 year. Materials and Methods: The study included 54 children aged 1.5–15 years who registered at the ART center, Surat, from August 2007 to August 2009. During the study period, the children were followed-up at 6 monthly intervals up to 1 year after starting ART. World Health Organization (WHO) clinical staging and CD4 cell count as per national guidelines, and nutritional status were used to measure clinical and immunologic progression of disease up to 1 year. Results: Out of 54 children, mother-to-child transmission was reported in 96.2% children; for 74% of the children, both parents were HIV positive. All the children were classified according to WHO clinical staging into 4 stages and as per CD4 cell count (%), followed up at 6 and 12 months and the benefits with ART reported. At 12 months follow-up, 15% of the study group children had died. Both mean CD4 count and a relative percentage showed significant increase (P < 0.01) in the study group 1 year after ART. Conclusion: The present study reports benefits of ART in terms of clinical and immunologic progression of disease, nutritional status of HIV-infected children after 1 year of ART. PMID:23230384
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Do team processes really have an effect on clinical performance? A systematic literature review.
Schmutz, J; Manser, T
2013-04-01
There is a growing literature on the relationship between team processes and clinical performance. The purpose of this review is to summarize these articles and examine the impact of team process behaviours on clinical performance. We conducted a literature search in five major databases. Inclusion criteria were: English peer-reviewed papers published between January 2001 and May 2012, which showed or tried to show (i) a statistical relationship of a team process variable and clinical performance or (ii) an improvement of a performance variable through a team process intervention. Study quality was assessed using predefined quality indicators. For every study, we calculated the relevant effect sizes. We included 28 studies in the review, seven of which were intervention studies. Every study reported at least one significant relationship between team processes or an intervention and performance. Also, some non-significant effects were reported. Most of the reported effect sizes were large or medium. The study quality ranged from medium to high. The studies are highly diverse regarding the specific team process behaviours investigated and also regarding the methods used. However, they suggest that team process behaviours do influence clinical performance and that training results in increased performance. Future research should rely on existing theoretical frameworks, valid, and reliable methods to assess processes such as teamwork or coordination and focus on the development of adequate tools to assess process performance, linking them with outcomes in the clinical setting.
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Zeng, Lingfeng; Liang, Weixiong; Pan, Jianke; Cao, Ye; Liu, Jun; Wang, Qi; Wang, Lu; Zou, Yuanping; Wang, Kezhu; Kong, Lingshuo; Xie, Hui; Xu, Weihua; Li, Weirong; Zhao, Wei; Mi, Suiqing; Chen, Yunbo; Cheng, Shuyi; Li, Xiaoyan; Cao, Qian; Zeng, Xing; Wang, Ningsheng
2016-03-25
Medical research using human participants must conform to the basic ethical principles found in the Declaration of Helsinki (DoH) of the World Medical Association. The purpose of this review was to assess whether journals in China have improved in regard to the fulfillment of ethical disclosure procedures for clinical trials of anti-dementia drugs. Four medical databases were searched for articles reporting clinical trials of oral anti-dementia drugs published in China in 2003, 2009, and 2014. The frequencies of reporting of informed consent from participants (ICP), approval of a regional ethical committee (REC), reference to DoH, and study registration were estimated respectively. Statistical analyses were conducted with SPSS v21 software. Among those randomized controlled trials published in 2003, 2009, and 2014, disclosure of REC approval was present for 2.67%, 1.15%, and 6.84%; statements of ICP were included in 9.33%, 7.76%, and 17.34%; reference to DoH was found for 4.00%, 1.44%, and 7.45%; and study registration reporting was included in 2.67%, 2.59%, and 9.28%, respectively. Improvements to reporting rates between 2009 and 2014 were seen, with more than twice as many trials reporting REC approval, ICP, reference to DoH, and study registration compared with 2009. Compared with 2003 and 2009, reporting rates for REC approval, ICP, reference to DoH, and study registration for clinical trials of anti-dementia drugs were enhanced in 2014 in the major medical journals of China. However, biomedical publications without definite statements of ethical considerations remain common, and this continues to be seen in Chinese journals. It is imperative that measures are taken to reinforce the ethical protection in clinical trials in China.
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van den Ende, Cornelia H. M.; Houterman, Anne E. J.; Heemskerk, Charlotte P. M.; van Dulmen, Sandra; van den Bemt, Bart J. F.
2017-01-01
Objective This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. Methods A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Results Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Conclusion Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF. PMID:28991903
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van Heuckelum, Milou; van den Ende, Cornelia H M; Houterman, Anne E J; Heemskerk, Charlotte P M; van Dulmen, Sandra; van den Bemt, Bart J F
2017-01-01
This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF.
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Clinical Outcome Reporting in Youth ACL Literature Is Widely Variable
Brusalis, Christopher M.; Lakomkin, Nikita; Suryavanshi, Joash R.; Cruz, Aristides I.; Green, Daniel W.; Jones, Kristofer J.; Fabricant, Peter D.
2017-01-01
Background: Advances in anterior cruciate ligament (ACL) reconstruction procedures in pediatric and adolescent patients have resulted in an increase in recent clinical studies on this topic. However, the consistency with which outcome measures are reported in this demographic is unknown. Purpose: To document outcome reporting patterns of youth ACL reconstruction studies in high-impact journals. Study Design: Systematic review; Level of evidence, 4. Methods: All articles published in 5 high-impact orthopaedic journals from 2010 to 2016 were reviewed to identify those reporting clinical outcomes of young patients who underwent ACL reconstruction. Studies that were nonclinical, reported on patients older than 18 years, or included fewer than 10 patients were excluded. Outcome measures used in all included studies were recorded. Results: Seventeen studies encompassing 772 subjects (mean age, 14.3 years; range, 6.3-18.0 years) were analyzed. Eight studies (47%) reported on Tanner stage of subjects, while 1 study reported skeletal age. Ten studies (59%) clearly documented the presence or absence of surgical complications. Range of motion was reported in 65% of studies. Leg-length discrepancy and angular deformity were each reported in 76% of studies, with 12% quantifying results through radiographic measurements. Ligament testing was variably defined by inclusion of instrumented testing (65%), Lachman test (53%), and pivot-shift test (53%). Fourteen studies (82%) explicitly reported on the rate of ACL rerupture, while 71% reported on the rate of revision surgery. Rate of return to preinjury activity was reported in 8 studies (47%), of which 2 defined criteria for return to sport and 3 defined the level of competitive sport. Patient-reported outcome measures (PROMs) were used variably. For the 3 most commonly reported PROMs (Lysholm, International Knee Documentation Committee, and Tegner), 24% of studies reported all 3 PROMs, 35% of studies reported 2 PROMs, and 6% of studies reported 1 PROM in isolation. A pediatric-specific PROM was reported in 1 of the 17 studies. Conclusion: Studies on pediatric ACL reconstruction published in high-impact journals unreliably defined subjects’ skeletal maturity, inconsistently reported on objective outcome measures, and used disparate adult-validated PROMs to assess subjective outcomes. These findings highlight the need for standardized, pediatric-specific outcome measures to be applied in future studies evaluating ACL reconstruction in children and adolescents. PMID:28840156
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Vázquez García, Rubén Eduardo; Hernández Bautista, Víctor; Espinosa Padilla, Sara
2006-01-01
The superantigens cause a massive polyclonal activation of T-cells, producing an immense liberation of proinflamatory cytokines, which induces the clinical data of toxic shock syndrome. In international studies the administration of polyclonal intravenous gammaglobulin has been observed to diminish the mortality 50 to 20%. But at the present it has not been reported in Mexico the clinical effectiveness of this therapeutic modality in toxic shock syndrome. We report three cases of toxic shock syndrome treated with gammaglobulin intravenous, and we describe their favorable clinical evolution.
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Randmaa, Maria; Mårtensson, Gunilla; Leo Swenne, Christine; Engström, Maria
2014-01-21
We aimed to examine staff members' perceptions of communication within and between different professions, safety attitudes and psychological empowerment, prior to and after implementation of the communication tool Situation-Background-Assessment-Recommendation (SBAR) at an anaesthetic clinic. The aim was also to study whether there was any change in the proportion of incident reports caused by communication errors. A prospective intervention study with comparison group using preassessments and postassessments. Questionnaire data were collected from staff in an intervention (n=100) and a comparison group (n=69) at the anaesthetic clinic in two hospitals prior to (2011) and after (2012) implementation of SBAR. The proportion of incident reports due to communication errors was calculated during a 1-year period prior to and after implementation. Anaesthetic clinics at two hospitals in Sweden. All licensed practical nurses, registered nurses and physicians working in the operating theatres, intensive care units and postanaesthesia care units at anaesthetic clinics in two hospitals were invited to participate. Implementation of SBAR in an anaesthetic clinic. The primary outcomes were staff members' perception of communication within and between different professions, as well as their perceptions of safety attitudes. Secondary outcomes were psychological empowerment and incident reports due to error of communication. In the intervention group, there were statistically significant improvements in the factors 'Between-group communication accuracy' (p=0.039) and 'Safety climate' (p=0.011). The proportion of incident reports due to communication errors decreased significantly (p<0.0001) in the intervention group, from 31% to 11%. Implementing the communication tool SBAR in anaesthetic clinics was associated with improvement in staff members' perception of communication between professionals and their perception of the safety climate as well as with a decreased proportion of incident reports related to communication errors. ISRCTN37251313.
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Stern, Judy E; McLain, Alexander C; Buck Louis, Germaine M; Luke, Barbara; Yeung, Edwina H
2016-08-01
It is unknown whether data obtained from maternal self-report for assisted reproductive technology treatment parameters and reproductive history are accurate for use in research studies. We evaluated the accuracy of self-reported in assisted reproductive technology treatment and reproductive history from the Upstate KIDS study in comparison with clinical data reported to the Society for Assisted Reproductive Technology Clinic Outcome Reporting System. Upstate KIDS maternal questionnaire data from deliveries between 2008 and 2010 were linked to data reported to Society for Assisted Reproductive Technology Clinic Outcome Reporting System. The 617 index deliveries were compared as to treatment type (frozen embryo transfer and donor egg or sperm) and use of intracytoplasmic sperm injection and assisted hatching. Use of injectable medications, self-report for assisted reproductive technology, or frozen embryo transfer prior to the index deliveries were also compared. We report agreement in which both sources had yes or both no and sensitivity of maternal report using Society for Assisted Reproductive Technology Clinic Outcome Reporting System as the gold standard. Significance was determined using χ(2) at P < 0.05. Universal agreement was not reached on any parameter but was best for treatment type of frozen embryo transfer (agreement, 96%; sensitivity, 93%) and use of donor eggs (agreement, 97%; sensitivity, 82%) or sperm (agreement, 98%; sensitivity, 82%). Use of intracytoplasmic sperm injection (agreement, 78%: sensitivity, 78%) and assisted hatching (agreement, 57%; sensitivity, 38%) agreed less well with self-reported use (P < .0001). In vitro fertilization (agreement, 82%) and frozen embryo transfer (agreement, 90%) prior to the index delivery were more consistently reported than was use of injectable medication (agreement, 76%) (P < .0001). Women accurately report in vitro fertilization treatment but are less accurate about procedures handled in the laboratory (intracytoplasmic sperm injection or assisted hatching). Clinics might better communicate with patients on the use of these procedures, and researchers should use caution when using self-reported treatment data. Copyright © 2016 Elsevier Inc. All rights reserved.
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Yu, Ashley M; Balasubramanaiam, Bannuya; Offringa, Martin; Kelly, Lauren E
2018-06-13
In pediatric medicine, the usual treatment received by children ("standard of care") varies across centers. Evaluations of new treatments often compare to the existing "standard of care" to determine if a treatment is more effective, has a better safety profile, or costs less. The objective of our study was to evaluate intervention and "standard of care" control arms reported in published pediatric clinical trials. Pediatric clinical trials, published in 2014, reporting the use of a "standard of care" control arm were included. Duplicate assessment of reporting completeness was done using the 12-item TIDieR (Template for Intervention Description and Replication) checklist for both the "standard of care" control arms and intervention arms within the same published study. Following screening, 214 pediatric trials in diverse therapeutic areas were included. Several different terms were used to describe "standard of care." There was a significant difference between the mean reported TIDieR checklist items of "standard of care" control arms (5.81 (SD 2.13) and intervention arms (8.45 (SD 1.39, p < 0.0001). Reporting of intervention and "standard of care" control arms in pediatric clinical trials should be improved as current "standard of care" reporting deficiencies limit reproducibility of research and may ultimately contribute to research waste.
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Diagnostic medical physicists and their clinical activities.
Cypel, Yasmin S; Sunshine, Jonathan H
2004-02-01
The primary objective of this study was to obtain basic, descriptive information about medical physicists involved in diagnostic radiology-related activities, the diagnostic-related activities that they performed, and the time spent on these activities. A survey was sent to a randomly selected sample of 1511 medical physicists from July through October 2001 using primarily e-mail methods; a total of 851 surveys was received, for a response rate of 56%. Of these, 427 were responses from physicists who do partly or only clinical diagnostic medical physics; it is this group for which results are presented. Fifty-four percent of the physicists who reported doing any clinical diagnostic medical physics performed clinical activities only in diagnostic medical physics. Fourteen percent of all those doing clinical diagnostic medical physics were women. Over 97% of the physicists doing clinical diagnostic medical physics reported having graduate degrees in physics; 53% had PhDs. The mean total weekly hours worked by physicists doing clinical diagnostic medical physics was 42. Medical physicists doing only clinical diagnostic activities reported working approximately 40 hours weekly, whereas those doing partly clinical diagnostic medical physics reported working 14 hours weekly in the field (approximately one-third of their work time). Radiography and fluoroscopy, computed tomography, nuclear medicine, and mammography are all fields in which the majority of those doing any clinical diagnostic medical physics are active. Full-time physicists working only in diagnostic medical physics were responsible for a median of 25 units of equipment, compared with a median of 10 units for those working only partly in the field. Number of units evaluated, frequency of evaluation, and hours per evaluation were reported for almost 20 types of equipment. Medical physicists performing diagnostic clinical activities typically are responsible for a large number and wide variety of imaging equipment. It would be helpful to study their work further, focusing in particular on whether there is a shortage, as is true of diagnostic radiologists, and whether the variety of responsibilities creates strain.
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Patient-Reported Outcomes of Periacetabular Osteotomy from the Prospective ANCHOR Cohort Study
Clohisy, John C.; Ackerman, Jeffrey; Baca, Geneva; Baty, Jack; Beaulé, Paul E.; Kim, Young-Jo; Millis, Michael B.; Podeszwa, David A.; Schoenecker, Perry L.; Sierra, Rafael J.; Sink, Ernest L.; Sucato, Daniel J.; Trousdale, Robert T.; Zaltz, Ira
2017-01-01
Background: Current literature describing the periacetabular osteotomy (PAO) is mostly limited to retrospective case series. Larger, prospective cohort studies are needed to provide better clinical evidence regarding this procedure. The goals of the current study were to (1) report minimum 2-year patient-reported outcomes (pain, hip function, activity, overall health, and quality of life), (2) investigate preoperative clinical and disease characteristics as predictors of clinical outcomes, and (3) report the rate of early failures and reoperations in patients undergoing contemporary PAO surgery. Methods: A large, prospective, multicenter cohort of PAO procedures was established, and outcomes at a minimum of 2 years were analyzed. A total of 391 hips were included for analysis (79% of the patients were female, and the average patient age was 25.4 years). Patient-reported outcomes, conversion to total hip replacement, reoperations, and major complications were documented. Variables with a p value of ≤0.10 in the univariate linear regressions were included in the multivariate linear regression. The backward stepwise selection method was used to determine the final risk factors of clinical outcomes. Results: Clinical outcome analysis demonstrated major clinically important improvements in pain, function, quality of life, overall health, and activity level. Increasing age and a body mass index status of overweight or obese were predictive of improved results for certain outcome metrics. Male sex and mild acetabular dysplasia were predictive of lesser improvements in certain outcome measures. Three (0.8%) of the hips underwent early conversion to total hip arthroplasty, 12 (3%) required reoperation, and 26 (7%) experienced a major complication. Conclusions: This large, prospective cohort study demonstrated the clinical success of contemporary PAO surgery for the treatment of symptomatic acetabular dysplasia. Patient and disease characteristics demonstrated predictive value that should be considered in surgical decision-making. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence. PMID:28060231
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Critical appraisal of clinical trials in multiple system atrophy: Toward better quality.
Castro Caldas, Ana; Levin, Johannes; Djaldetti, Ruth; Rascol, Olivier; Wenning, Gregor; Ferreira, Joaquim J
2017-10-01
Multiple system atrophy (MSA) is a rare neurodegenerative disease of undetermined cause. Although many clinical trials have been conducted, there is still no treatment that cures the disease or slows its progression. We sought to assess the clinical trials, methodology, and quality of reporting of clinical trails conducted in MSA patients. We conducted a systematic review of all trials with at least 1 MSA patient subject to any pharmacological/nonpharmacological interventions. Two independent reviewers evaluated the methodological characteristics and quality of reporting of trials. A total of 60 clinical trials were identified, including 1375 MSA patients. Of the trials, 51% (n = 31) were single-arm studies. A total of 28% (n = 17) had a parallel design, half of which (n = 13) were placebo controlled. Of the studies, 8 (13.3%) were conducted in a multicenter setting, 3 of which were responsible for 49.3% (n = 678) of the total included MSA patients. The description of primary outcomes was unclear in 60% (n = 40) of trials. Only 10 (16.7%) clinical trials clearly described the randomization process. Blinding of the participants, personnel, and outcome assessments were at high risk of bias in the majority of studies. The number of dropouts/withdrawals was high (n = 326, 23.4% among the included patients). Overall, the design and quality of reporting of the reviewed studies is unsatisfactory. The most frequent clinical trials were small and single centered. Inadequate reporting was related to the information on the randomization process, sequence generation, allocation concealment, blinding of participants, and sample size calculations. Although improved during the recent years, methodological quality and trial design need to be optimized to generate more informative results. © 2017 International Parkinson and Movement Disorder Society. © 2017 International Parkinson and Movement Disorder Society.
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Capelouto, Sarah M; Archer, Sydney R; Morris, Jerrine R; Kawwass, Jennifer F; Hipp, Heather S
2018-03-01
This study aimed to determine the current percentage of United States (U.S.) assisted reproductive technology (ART) clinics offering sex selection via pre-implantation genetic screening (PGS) for non-medical purposes. The authors conducted website review and telephone interview survey of 493 U.S. ART clinics performing in vitro fertilization (IVF) in 2017. Main outcome measures were pre-implantation genetic screening (PGS)/pre-implantation genetic diagnosis (PGD) practices and non-medical sex selection practices including family balancing. Of the 493 ART clinics in the USA, 482 clinics (97.8%) responded to our telephone interview survey. Among all U.S. ART clinics, 91.9% (n = 449) reported offering PGS and/or PGD. Furthermore, 476 clinics responded to survey questions about sex selection practices. Of those ART clinics, 72.7% (n = 346) reported offering sex selection. More specifically among those clinics offering sex selection, 93.6% (n = 324) reported performing sex selection for family balancing, and 81.2% (n = 281) reported performing for elective purposes (patient preference, regardless of rationale for the request). For couples without infertility, 83.5% (n = 289) of clinics offer sex selection for family balancing and 74.6% (n = 258) for non-specific elective reasons. The majority of U.S. ART clinics offer non-medical sex selection, a percentage that has increased substantially since last reported in 2006.
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Registration practices for observational studies on ClinicalTrials.gov indicated low adherence.
Boccia, Stefania; Rothman, Kenneth J; Panic, Nikola; Flacco, Maria Elena; Rosso, Annalisa; Pastorino, Roberta; Manzoli, Lamberto; La Vecchia, Carlo; Villari, Paolo; Boffetta, Paolo; Ricciardi, Walter; Ioannidis, John P A
2016-02-01
The study aims to assess the status of registration of observational studies. We identified studies on cancer research with prospective recruitment of participants that were registered from February 2000 to December 2011 in ClinicalTrials.gov. We recorded the dates of registration and start of recruitment, outcomes, and description of statistical method. We searched for publications corresponding to the registered studies through May 31, 2014. One thousand one hundred nine registered studies were eligible. Primary and secondary outcomes were reported in 809 (73.0%) and 464 (41.8%) of them. The date of registration preceded the month of the study start in 145 (13.8%) and coincided in 205 (19.5%). A total of 151 publications from 120 (10.8%) registered studies were identified. In 2 (33.3%) of the 6 publications where ClinicalTrials.gov reported that the study started recruitment after registration, and in 9 (50.0%) of 18 publications where ClinicalTrials.gov reported the same date for registration and start of recruitment, the articles showed that the study had actually started recruiting before registration. During the period reviewed, few observational studies have been registered. Registration usually occurred after the study started, and prespecification of outcomes and statistical analysis rarely occurred. Copyright © 2016 Elsevier Inc. All rights reserved.
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The administration of probiotics and synbiotics in immune compromised adults: is it safe?
Van den Nieuwboer, M; Brummer, R J; Guarner, F; Morelli, L; Cabana, M; Claasen, E
2015-03-01
This study aimed to systematically evaluate safety of probiotics and synbiotics in immune compromised adults (≥18 years). Safety was analysed using the Common Terminology Clinical Adverse Events (CTCAE version 4.0) classification, thereby providing an update on previous reports using the most recent available clinical data (2008-2013). Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. Analysis of 57 clinical studies indicates that probiotic and/or synbiotic administration in immune compromised adults is safe with regard to the current evaluated probiotic strains, dosages and duration. Individuals were considered immune compromised if HIV-infected, critically ill, underwent surgery or had an organ- or an autoimmune disease. There were no major safety concerns in the study, as none of the serious adverse events (AE)s were related, or suspected to be related, to the probiotic or synbiotic product and the study products were well tolerated. Overall, AEs occurred less frequent in immune compromised subjects receiving probiotics and/or synbiotics compared to the control group. In addition, the results demonstrated a flaw in precise reporting and classification of AE in most studies. Furthermore, generalisability of conclusions are greatly limited by the inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes. We argue that standardised reporting on adverse events (CTCAE) in 'food' studies should be obligatory, thereby improving reliability of data and re-enforcing the safety profile of probiotics.
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Understanding the Potential Interethnic Difference in Rosuvastatin Pharmacokinetics.
Benet, Leslie Z; Wu, Hsin-Fang
2017-09-01
Here we address the potential difference in rosuvastatin pharmacokinetics in Asians vs. whites. Our prospective study, reported in this issue, shows no ethnic difference when all subjects are wild-type for OATP1B1 and BCRP. We argue that although our study may be under powered to prove no ethnic difference, and that further confirmatory study is required, the virtual clinical study analysis, also reported in this issue, does not contradict the results of our prospective clinical study and that previous retrospective analysis of clinical studies does not include enough relevant subjects to conclude that wild-type OATP1B1 and BCRP do still demonstrate ethnic differences. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
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Depression and parenting by nonoffending mothers of children who experienced sexual abuse.
Santa-Sosa, Eileen J; Steer, Robert A; Deblinger, Esther; Runyon, Melissa K
2013-01-01
Parenting may be one mechanism by which depression in nonoffending mothers impacts child emotional and behavioral adjustment after sexual abuse. This study examined the relationship between self-reported maternal depression and parenting behaviors by nonoffending mothers of children who experienced sexual abuse. The participants were 204 nonoffending biological mother-child pairs recruited from a clinic providing services for children who experienced sexual abuse. The mothers completed pretreatment self-report measures of demographic information, depression, and parenting behaviors. Children (7 to 17 years) completed a measure of mothers' parenting behaviors. Mothers with clinically high levels of self-reported depression employed more inconsistent parenting behavior and provided poorer monitoring/supervision of their children than mothers without clinically high levels of self-reported depression. Implications for clinical practice and future research are discussed.
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Mental Subnormality in the Community: A Clinical and Epidemiologic Study.
ERIC Educational Resources Information Center
Birch, Herbert G.; And Others
The book reports a clinical and epidemiologic study of the prevalence, distribution, and antecedents of mental subnormality in 8 to 10 year old children living in Aberdeen, Scotland (population 187,000). Utilizing three types of data (differential clinical diagnoses, biological background information, and social characteristics), the study…
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Description of interventions is under-reported in physical therapy clinical trials.
Hariohm, K; Jeyanthi, S; Kumar, J Saravan; Prakash, V
Amongst several barriers to the application of quality clinical evidence and clinical guidelines into routine daily practice, poor description of interventions reported in clinical trials has received less attention. Although some studies have investigated the completeness of descriptions of non-pharmacological interventions in randomized trials, studies that exclusively analyzed physical therapy interventions reported in published trials are scarce. To evaluate the quality of descriptions of interventions in both experimental and control groups in randomized controlled trials published in four core physical therapy journals. We included all randomized controlled trials published from the Physical Therapy Journal, Journal of Physiotherapy, Clinical Rehabilitation, and Archives of Physical Medicine and Rehabilitation between June 2012 and December 2013. Each randomized controlled trial (RCT) was analyzed and coded for description of interventions using the checklist developed by Schroter et al. Out of 100 RCTs selected, only 35 RCTs (35%) fully described the interventions in both the intervention and control groups. Control group interventions were poorly described in the remaining RCTs (65%). Interventions, especially in the control group, are poorly described in the clinical trials published in leading physical therapy journals. A complete description of the intervention in a published report is crucial for physical therapists to be able to use the intervention in clinical practice. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.
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Inadequate management of pregnancy-associated listeriosis: lessons from four case reports.
Charlier, C; Goffinet, F; Azria, E; Leclercq, A; Lecuit, M
2014-03-01
Listeria monocytogenes infection during pregnancy can lead to dramatic fetal or neonatal outcomes. No clinical trial has evaluated treatment options, and retrospective studies of cases are therefore important to define optimal regimens. We report four cases of materno-neonatal listeriosis illustrating inadequate antimicrobial therapy management and discuss recommended treatment options. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.
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Rosenblat, Joshua D; Lee, Yena; McIntyre, Roger S
2017-06-01
Pharmacogenomic testing has become scalable and available to the general public. Pharmacogenomics has shown promise for predicting antidepressant response and tolerability in the treatment of major depressive disorder (MDD). In theory, pharmacogenomics can improve clinical outcomes by guiding antidepressant selection and dosing. The current systematic review examines the extant literature to determine the impact of pharmacogenomic testing on clinical outcomes in MDD and assesses its cost-effectiveness. The MEDLINE/PubMed and Google Scholar databases were systematically searched for relevant articles published prior to October 2015. Search terms included various combinations of the following: major depressive disorder (MDD), depression, mental illness, mood disorder, antidepressant, response, remission, outcome, pharmacogenetic, pharmacogenomics, pharmacodynamics, pharmacokinetic, genetic testing, genome wide association study (GWAS), CYP450, personalized medicine, cost-effectiveness, and pharmacoeconomics. Of the 66 records identified from the initial search, relevant clinical studies, written in English, assessing the cost-effectiveness and/or efficacy of pharmacogenomic testing for MDD were included. Each publication was critically examined for relevant data. Two nonrandomized, open-label, 8-week, prospective studies reported overall greater improvement in depressive symptom severity in the group of MDD subjects receiving psychiatric care guided by results of combinatorial pharmacogenomic testing (GeneSight) when compared to the unguided group. One industry-sponsored, randomized, double-blind, 10-week prospective study reported a trend for improved outcomes for the GeneSight-guided group; however, the trend did not reach statistical significance. Another industry-sponsored, randomized, double-blind, 12-week prospective study reported a 2.5-fold increase in remission rates in the CNSDose-guided group (P < .0001). One naturalistic, unblinded, industry-sponsored study showed clinical improvement when pharmacogenomics testing guided prescribing; however, this study lacked a control group. A single cost-effectiveness study concluded that single gene testing was not cost-effective. Conversely, a separate study reported that combinatorial pharmacogenomic testing is cost-effective. A limited number of studies have shown promise for the clinical utility of pharmacogenomic testing; however, cost-effectiveness of pharmacogenomics, as well as demonstration of improved health outcomes, is not yet supported with replicated evidence. © Copyright 2017 Physicians Postgraduate Press, Inc.
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PEDIATRIC PROVIDERS’ ATTITUDES TOWARD RETAIL CLINICS
Garbutt, Jane M.; Mandrell, Kathy M.; Sterkel, Randall; Epstein, Jay; Stahl, Kristin; Kreusser, Katherine; O’Neil, Jerome; Sitrin, Harold; Ariza, Adolfo; Reis, Evelyn Cohen; Siegel, Robert; Pascoe, John; Strunk, Robert C.
2013-01-01
Objective To describe pediatric primary care providers’ attitudes toward retail clinics and their experiences of retail clinics use by their patients. Study design A 51-item, self-administered survey from four pediatric practice-based research networks from the Midwestern United States, which gauged providers’ attitudes toward and perceptions of their patients’ interactions with retail clinics, and changes to office practice to better compete. Results A total of 226 providers participated (50% response). Providers believed that retail clinics were a business threat (80%) and disrupted continuity of chronic disease management (54%). Few (20%) agreed that retail clinics provided care within recommended clinical guidelines. Most (91%) reported that they provided additional care after a retail clinic visit (median 1–2 times per week) and 37% felt this resulted from suboptimal care at retail clinics “most or all of the time.” Few (15%) reported being notified by the retail clinic within 24 hours of a patient visit. Those reporting prompt communication were less likely to report suboptimal retail clinic care (OR 0.20, 95%CI 0.10 to 0.42) or disruption in continuity of care (OR 0.32, 95%CI 0.15 to 0.71). Thirty-six percent reported changes to office practice to compete with retail clinics (most commonly adjusting or extending office hours) and change was more likely if retail clinics were perceived as a threat (OR 3.70, 95%CI 1.56 to 8.76); 30% planned to make changes in the near future. Conclusions Based on the perceived business threat, pediatric providers are making changes to their practice to compete with retail clinics. Improved communication between the clinic and providers may improve collaboration. PMID:23810720
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Psychiatrists’ Comfort Using Computers and Other Electronic Devices in Clinical Practice
Fochtmann, Laura J.; Clarke, Diana E.; Barber, Keila; Hong, Seung-Hee; Yager, Joel; Mościcki, Eve K.; Plovnick, Robert M.
2015-01-01
This report highlights findings from the Study of Psychiatrists’ Use of Informational Resources in Clinical Practice, a cross-sectional Web- and paper-based survey that examined psychiatrists’ comfort using computers and other electronic devices in clinical practice. One-thousand psychiatrists were randomly selected from the American Medical Association Physician Masterfile and asked to complete the survey between May and August, 2012. A total of 152 eligible psychiatrists completed the questionnaire (response rate 22.2 %). The majority of psychiatrists reported comfort using computers for educational and personal purposes. However, 26 % of psychiatrists reported not using or not being comfortable using computers for clinical functions. Psychiatrists under age 50 were more likely to report comfort using computers for all purposes than their older counterparts. Clinical tasks for which computers were reportedly used comfortably, specifically by psychiatrists younger than 50, included documenting clinical encounters, prescribing, ordering laboratory tests, accessing read-only patient information (e.g., test results), conducting internet searches for general clinical information, accessing online patient educational materials, and communicating with patients or other clinicians. Psychiatrists generally reported comfort using computers for personal and educational purposes. However, use of computers in clinical care was less common, particularly among psychiatrists 50 and older. Information and educational resources need to be available in a variety of accessible, user-friendly, computer and non-computer-based formats, to support use across all ages. Moreover, ongoing training and technical assistance with use of electronic and mobile device technologies in clinical practice is needed. Research on barriers to clinical use of computers is warranted. PMID:26667248
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Psychiatrists' Comfort Using Computers and Other Electronic Devices in Clinical Practice.
Duffy, Farifteh F; Fochtmann, Laura J; Clarke, Diana E; Barber, Keila; Hong, Seung-Hee; Yager, Joel; Mościcki, Eve K; Plovnick, Robert M
2016-09-01
This report highlights findings from the Study of Psychiatrists' Use of Informational Resources in Clinical Practice, a cross-sectional Web- and paper-based survey that examined psychiatrists' comfort using computers and other electronic devices in clinical practice. One-thousand psychiatrists were randomly selected from the American Medical Association Physician Masterfile and asked to complete the survey between May and August, 2012. A total of 152 eligible psychiatrists completed the questionnaire (response rate 22.2 %). The majority of psychiatrists reported comfort using computers for educational and personal purposes. However, 26 % of psychiatrists reported not using or not being comfortable using computers for clinical functions. Psychiatrists under age 50 were more likely to report comfort using computers for all purposes than their older counterparts. Clinical tasks for which computers were reportedly used comfortably, specifically by psychiatrists younger than 50, included documenting clinical encounters, prescribing, ordering laboratory tests, accessing read-only patient information (e.g., test results), conducting internet searches for general clinical information, accessing online patient educational materials, and communicating with patients or other clinicians. Psychiatrists generally reported comfort using computers for personal and educational purposes. However, use of computers in clinical care was less common, particularly among psychiatrists 50 and older. Information and educational resources need to be available in a variety of accessible, user-friendly, computer and non-computer-based formats, to support use across all ages. Moreover, ongoing training and technical assistance with use of electronic and mobile device technologies in clinical practice is needed. Research on barriers to clinical use of computers is warranted.
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Pandis, Nikolaos; Polychronopoulou, Argy; Madianos, Phoebus; Makou, Margarita; Eliades, Theodore
2011-06-01
The objective of this article was to record reporting characteristics related to study quality of research published in major specialty dental journals with the highest impact factor (Journal of Endodontics, Journal of Oral and Maxillofacial Surgery, American Journal of Orthodontics and Dentofacial Orthopedics; Pediatric Dentistry, Journal of Clinical Periodontology, and International Journal of Prosthetic Dentistry). The included articles were classified into the following 3 broad subject categories: (1) cross-sectional (snap-shot), (2) observational, and (3) interventional. Multinomial logistic regression was conducted for effect estimation using the journal as the response and randomization, sample calculation, confounding discussed, multivariate analysis, effect measurement, and confidence intervals as the explanatory variables. The results showed that cross-sectional studies were the dominant design (55%), whereas observational investigations accounted for 13%, and interventions/clinical trials for 32%. Reporting on quality characteristics was low for all variables: random allocation (15%), sample size calculation (7%), confounding issues/possible confounders (38%), effect measurements (16%), and multivariate analysis (21%). Eighty-four percent of the published articles reported a statistically significant main finding and only 13% presented confidence intervals. The Journal of Clinical Periodontology showed the highest probability of including quality characteristics in reporting results among all dental journals. Copyright © 2011 Elsevier Inc. All rights reserved.
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Clinical characterization and treatment outcome of patients with burning mouth syndrome.
Hakeem, Abdulaziz; Fitzpatrick, Sarah G; Bhattacharyya, Indraneel; Islam, Mohammed N; Cohen, Donald M
2018-01-01
Burning mouth syndrome (BMS) is a complex condition that affects the oral cavity, and data regarding effective treatment are limited. The purpose of this study was to explore the demographic and clinical information along with treatment outcomes for patients with BMS treated in a large referral center. Clinical records of the Oral Medicine Clinic at the University of Florida College of Dentistry were retrospectively searched for patients diagnosed between 2009 and 2014. Clinical data and treatment effectiveness were recorded. The records of 64 patients were included in this study. Women represented the majority of patients (81.2%), and the average age of all patients was 65 years. The most common systemic diseases were hypertension (59.4%), psycho-logical disorders (51.6%), and gastroesophageal reflux disease (50.0%). The majority of patients were taking 5 or more medications (70.3%). Treatment frequency and efficacy were as follows: a-lipoic acid, 47.5% frequency (57 prescribed treatments of 120 total treatments) and lasting improvement reported with 45.6% of prescribed treatments; clonazepam, 17.5% frequency (21/120) and improvement reported with 33.0% of prescribed treatments; oral disintegrating clonazepam, 15.8% frequency (19/120) and improvement reported with 52.6% of prescribed treatments; and topical vitamin E, 5.0% frequency (6/120) and improvement reported with 33.0% of prescribed treatments. Chi-square analysis indicated that a significantly better response to treatment was reported by women (P = 0.010) and patients who reported involvement limited to the tongue rather than multifocal oral involvement (P = 0.040); however, the significant relationships did not persist when the variables were evaluated together using logistic regression analysis. No other clinical or demographic features showed significant differences in response to treatment. Although treatment effectiveness in this study was variable and limited for some regimens due to infrequent usage, many of the patients reported alleviation of symptoms.
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Magnitude and risk factors for postpartum symptoms: a literature review.
Norhayati, M N; Hazlina, N H Nik; Asrenee, A R; Emilin, W M A Wan
2015-04-01
The prevalence of postpartum depression worldwide varies from 0.5% to 60.8% in the first 12 months postpartum using self-reported questionnaire. This review aims to update the current magnitude of postpartum depression based on self-reported questionnaire and clinical interview and explore its associated factors in developed and developing countries. A literature search conducted between 2005 and 2014 identified 203 studies, of which 191 used self-reported questionnaire in 42 countries and 21 used structured clinical interview in 15 countries. Nine studies used a combination of self-reported questionnaire and clinical interview. The prevalence of postpartum depression varies from 1.9% to 82.1% in developing countries and from 5.2% to 74.0% in developed countries using self-reported questionnaire. Structured clinical interview shows a much lower prevalence range from 0.1% in Finland to 26.3% in India. Antenatal depression and anxiety, previous psychiatric illness, poor marital relationship, stressful life events, negative attitude towards pregnancy, and lack of social support are significant contributors to postpartum depression. All studies are included irrespective of the methodological quality, such as small sample size and their inclusion could affect the generalizability of the results. The current prevalence of postpartum depression is much higher than that previously reported, and similar risk factors are documented. A culturally sensitive cut-off score with adequate psychometric properties of the screening instruments should be available. In future studies, examining the physical, biological, and cultural factors in qualitative studies and in those with adequate methodological qualities is recommended. Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.
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Wang, Michael T. M.; Gamble, Greg; Bolland, Mark J.; Grey, Andrew
2014-01-01
Background Dietary supplement use is increasing despite lack of evidence of benefits, or evidence of harm. Press releases issued by the supplements industry might contribute to this situation by using ‘spin’ (strategies to hype or denigrate findings) to distort the results of clinical studies. We assessed press releases issued in response to publication of clinical studies on dietary supplements. Methods and Findings We analyzed 47 supplements industry press releases and 91 non-industry press releases and news stories, generated in response to 46 clinical studies of dietary supplements published between 1/1/2005 and 5/31/2013. The primary outcome was ‘spin’ content and direction. We also assessed disposition towards use of dietary supplements, reporting of study information, and dissemination of industry press releases. More supplements industry press releases (100%) contained ‘spin’ than non-industry media documents (55%, P<0.001). Hyping ‘spin’ scores were higher in industry than non-industry media documents for studies reporting benefit of supplements (median ‘spin’ score 3.3, 95% CI 1.0–5.5 vs 0.5, 0–1.0; P<0.001). Denigratory ‘spin’ scores were higher in industry than non-industry media documents for studies reporting no effect (6.0, 5.0–7.0 vs 0, 0–0; P<0.001) or harm (6.0, 5.5–7.5 vs 0, 0–0.5; P<0.001) from a supplement. Industry press releases advocated supplement use in response to >90% of studies that reported no benefit, or harm, of the supplement. Industry press releases less frequently reported study outcomes, sample size, and estimates of effect size than non-industry media documents (all P<0.001), particularly for studies that reported no benefit of supplements. Industry press releases were referenced by 148 news stories on the websites of 6 organizations that inform manufacturers, retailers and consumers of supplements. Conclusions Dietary supplements industry press releases issued in response to clinical research findings are characterized by ‘spin’ that hypes results that are favourable to supplement use and denigrates results that are not. PMID:24992571
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Wang, Michael T M; Gamble, Greg; Bolland, Mark J; Grey, Andrew
2014-01-01
Dietary supplement use is increasing despite lack of evidence of benefits, or evidence of harm. Press releases issued by the supplements industry might contribute to this situation by using 'spin' (strategies to hype or denigrate findings) to distort the results of clinical studies. We assessed press releases issued in response to publication of clinical studies on dietary supplements. We analyzed 47 supplements industry press releases and 91 non-industry press releases and news stories, generated in response to 46 clinical studies of dietary supplements published between 1/1/2005 and 5/31/2013. The primary outcome was 'spin' content and direction. We also assessed disposition towards use of dietary supplements, reporting of study information, and dissemination of industry press releases. More supplements industry press releases (100%) contained 'spin' than non-industry media documents (55%, P<0.001). Hyping 'spin' scores were higher in industry than non-industry media documents for studies reporting benefit of supplements (median 'spin' score 3.3, 95% CI 1.0-5.5 vs 0.5, 0-1.0; P<0.001). Denigratory 'spin' scores were higher in industry than non-industry media documents for studies reporting no effect (6.0, 5.0-7.0 vs 0, 0-0; P<0.001) or harm (6.0, 5.5-7.5 vs 0, 0-0.5; P<0.001) from a supplement. Industry press releases advocated supplement use in response to >90% of studies that reported no benefit, or harm, of the supplement. Industry press releases less frequently reported study outcomes, sample size, and estimates of effect size than non-industry media documents (all P<0.001), particularly for studies that reported no benefit of supplements. Industry press releases were referenced by 148 news stories on the websites of 6 organizations that inform manufacturers, retailers and consumers of supplements. Dietary supplements industry press releases issued in response to clinical research findings are characterized by 'spin' that hypes results that are favourable to supplement use and denigrates results that are not.
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Implementing Trauma-Informed Partner Violence Assessment in Family Planning Clinics.
Decker, Michele R; Flessa, Sarah; Pillai, Ruchita V; Dick, Rebecca N; Quam, Jamie; Cheng, Diana; McDonald-Mosley, Raegan; Alexander, Kamila A; Holliday, Charvonne N; Miller, Elizabeth
2017-09-01
Intimate partner violence (IPV) and reproductive coercion (RC) are associated with poor reproductive health. Little is known about how family planning clinics implement brief IPV/RC assessment interventions in practice. We describe the uptake and impact of a brief, trauma-informed, universal IPV/RC assessment and education intervention. Intervention implementation was evaluated via a mixed methods study among women ages 18 and up receiving care at one of two family planning clinics in greater Baltimore, MD. This mixed methods study entailed a quasi-experimental, single group pretest-posttest study with family planning clinic patients (baseline and exit survey n = 132; 3-month retention n = 68; retention rate = 52%), coupled with qualitative interviews with providers and patients (total n = 35). Two thirds (65%) of women reported receiving at least one element of the intervention on their exit survey immediately following the clinic-visit. Patients reported that clinic-based IPV assessment is helpful, irrespective of IPV history. Relative to those who reported neither, participants who received either intervention element reported greater perceived caring from providers, confidence in provider response to abusive relationships, and knowledge of IPV-related resources at follow-up. Providers and patients alike described the educational card as a valuable tool. Participants described trade-offs of paper versus in-person, electronic medical record-facilitated screening, and patient reluctance to disclose current situations of abuse. In real-world family planning clinic settings, a brief assessment and support intervention was successful in communicating provider caring and increasing knowledge of violence-related resources, endpoints previously deemed valuable by IPV survivors. Results emphasize the merit of universal education in IPV/RC clinical interventions over seeking IPV disclosure.
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A survey of occupational skin disease in UK health care workers.
Campion, K M
2015-01-01
Occupational skin disease is a common problem among health care workers (HCWs). The prevalence of occupational skin disease in HCWs has been reported in several international studies, but not in the UK. To estimate the prevalence of occupational skin disease in a population of UK HCWs and to explore possible causative factors. Clinical and non-clinical HCWs attending for an influenza vaccine during October and November 2013 were invited to complete a brief skin questionnaire. Data from staff who stated their skin had suffered as a result of work were compared with data from staff who did not, to explore differences in potential causative factors. A total of 2762 questionnaires were analysed. The estimated prevalence of occupational skin disease was 20% for clinical and 7% for non-clinical staff. In total, 424 clinical staff stated their skin had been made worse by work. There were statistically significant differences between clinical staff with and without reported skin symptoms regarding a history of eczema, frequent hand washing and moisturizer use but no statistically significant difference in the relative proportions of soap and alcohol hand gel use. Non-clinical staff reported significantly more use of soap relative to alcohol gel than clinical staff. This study demonstrated the prevalence of occupational skin disease in a population of UK HCWs. More work is indicated to explore if the ratio of soap and alcohol gel reported in this study are typical and whether this has any impact on the development of occupational skin disease. © The Author 2014. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.
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Informatics tools to improve clinical research study implementation.
Brandt, Cynthia A; Argraves, Stephanie; Money, Roy; Ananth, Gowri; Trocky, Nina M; Nadkarni, Prakash M
2006-04-01
There are numerous potential sources of problems when performing complex clinical research trials. These issues are compounded when studies are multi-site and multiple personnel from different sites are responsible for varying actions from case report form design to primary data collection and data entry. We describe an approach that emphasizes the use of a variety of informatics tools that can facilitate study coordination, training, data checks and early identification and correction of faulty procedures and data problems. The paper focuses on informatics tools that can help in case report form design, procedures and training and data management. Informatics tools can be used to facilitate study coordination and implementation of clinical research trials.
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The Impact of Generic Substitution on Health and Economic Outcomes: A Systematic Review.
Gothe, H; Schall, I; Saverno, K; Mitrovic, M; Luzak, A; Brixner, D; Siebert, U
2015-08-01
Generic drugs are considered therapeutically equivalent to their original counterparts and lower in acquisition costs. However, the overall impact of generic substitution (GS) on global clinical and economic outcomes has not been conclusively evaluated. To test whether (1) generics and original products yield the same health outcomes, and (2) generic therapies save economic resources versus original therapies. We performed a systematic literature review in Medline, Embase, and the Cochrane Database of Systematic Reviews to identify original studies that examine clinical or economic outcomes of GS. After standardized data extraction, reported outcomes were categorized as supporting or rejecting the hypotheses. Each reported outcome was assessed and accounted for supporting and opposing GS. One publication could provide multiple outcome comparisons. We included 40 studies across ten therapeutic areas. Fourteen studies examined patients on de novo therapy; 24 studies investigated maintenance drug therapy, and two studies considered both settings. Overall, 119 outcome comparisons were examined. Of 97 clinical outcome comparisons, 67% reported no significant difference between generic drugs and their off-patent counterparts. Of 22 economic comparisons, 64% suggested that GS increased costs. Consequently, hypothesis (1) was supported but hypothesis (2) was not. We found no major differences among studies that investigated clinical outcomes with de novo or maintenance therapy. The review suggests that clinical effects are similar after GS. However, economic savings are not guaranteed. More systematic research comparing clinical and economic outcomes with or without GS is needed to inform policy on the use of generic substitution.
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Echinocandin Resistance in Candida Species: a Review of Recent Developments.
Wiederhold, Nathan P
2016-12-01
The echinocandins are important agents for the treatment of invasive fungal infections, especially those caused by Candida species. However, as with other antimicrobial agents, microbiologic resistance to this class of antifungal agents has emerged and can result in clinical failure. Several studies have recently reported an increase in echinocandin resistance in Candida glabrata isolates at various medical centers in different geographic regions of the USA. Recent studies have also reported that many of these isolates may also be fluconazole resistant, leaving few treatment options available for clinicians to use in patients with invasive candidiasis caused by this species. Our understanding of the clinical relevance of specific point mutations within the FKS genes that cause echinocandin resistance and risk factors for the development of microbiologic resistance and clinical failure have also increased. The purpose of this review is to discuss echinocandin resistance in Candida species and recent reports that have increased our understanding of this growing clinical problem.
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Semi-Supervised Approach to Monitoring Clinical Depressive Symptoms in Social Media
Yazdavar, Amir Hossein; Al-Olimat, Hussein S.; Ebrahimi, Monireh; Bajaj, Goonmeet; Banerjee, Tanvi; Thirunarayan, Krishnaprasad; Pathak, Jyotishman; Sheth, Amit
2017-01-01
With the rise of social media, millions of people are routinely expressing their moods, feelings, and daily struggles with mental health issues on social media platforms like Twitter. Unlike traditional observational cohort studies conducted through questionnaires and self-reported surveys, we explore the reliable detection of clinical depression from tweets obtained unobtrusively. Based on the analysis of tweets crawled from users with self-reported depressive symptoms in their Twitter profiles, we demonstrate the potential for detecting clinical depression symptoms which emulate the PHQ-9 questionnaire clinicians use today. Our study uses a semi-supervised statistical model to evaluate how the duration of these symptoms and their expression on Twitter (in terms of word usage patterns and topical preferences) align with the medical findings reported via the PHQ-9. Our proactive and automatic screening tool is able to identify clinical depressive symptoms with an accuracy of 68% and precision of 72%. PMID:29707701
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Doron, Shira; Snydman, David R.
2015-01-01
Probiotics have been used safely for years. Safety outcomes are inconsistently reported in published clinical trials. In 2011, a report released by the Agency for Healthcare Research and Quality concluded that, although the existing probiotic clinical trials reveal no evidence of increased risk, “the current literature is not well equipped to answer questions on the safety of probiotics in intervention studies with confidence.” Critics point out that the preponderance of evidence, including the long history of safe probiotic use as well as data from clinical trials, and animal and in vitro studies all support the assumption that probiotics are generally safe for most populations. Theoretical risks have been described in case reports, clinical trial results and experimental models, include systemic infections, deleterious metabolic activities, excessive immune stimulation in susceptible individuals, gene transfer and gastrointestinal side effects. More research is needed to properly describe the incidence and severity of adverse events related to probiotics. PMID:25922398
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Snow, Aisling; Milliren, Carly E; Graham, Dionne A; Callahan, Michael J; MacDougall, Robert D; Robertson, Richard L; Taylor, George A
2017-04-01
Pediatric patients requiring transfer to a dedicated children's hospital from an outside institution may undergo CT imaging as part of their evaluation. Whether this imaging is performed prior to or after transfer has been shown to impact the radiation dose imparted to the patient. Other quality variables could also be affected by the pediatric experience and expertise of the scanning institution. To identify differences in quality between abdominal CT scans and reports performed at a dedicated children's hospital, and those performed at referring institutions. Fifty consecutive pediatric abdominal CT scans performed at outside institutions were matched (for age, gender and indication) with 50 CT scans performed at a dedicated freestanding children's hospital. We analyzed the scans for technical parameters, report findings, correlation with final clinical diagnosis, and clinical utility. Technical evaluation included use of intravenous and oral contrast agents, anatomical coverage, number of scan phases and size-specific dose estimate (SSDE) for each scan. Outside institution scans were re-reported when the child was admitted to the children's hospital; they were also re-interpreted for this study by children's hospital radiologists who were provided with only the referral information given in the outside institution's report. Anonymized original outside institutional reports and children's hospital admission re-reports were analyzed by two emergency medicine physicians for ease of understanding, degree to which the clinical question was answered, and level of confidence in the report. Mean SSDE was lower (8.68) for children's hospital scans, as compared to outside institution scans (13.29, P = 0.03). Concordance with final clinical diagnosis was significantly lower for original outside institution reports (38/48, 79%) than for both the admission and study children's hospital reports (48/50, 96%; P = 0.005). Children's hospital admission reports were rated higher than outside institution reports for completeness, ease of understanding, answering of clinical question, and level of confidence of the report (P < 0.001). Pediatric abdominal CT scans performed and interpreted at a dedicated children's hospital are associated with higher technical quality, lower radiation dose and a more clinically useful report than those performed at referring institutions.
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Automated Transformation of CDISC ODM to OpenClinica.
Gessner, Sophia; Storck, Michael; Hegselmann, Stefan; Dugas, Martin; Soto-Rey, Iñaki
2017-01-01
Due to the increasing use of electronic data capture systems for clinical research, the interest in saving resources by automatically generating and reusing case report forms in clinical studies is growing. OpenClinica, an open-source electronic data capture system enables the reuse of metadata in its own Excel import template, hampering the reuse of metadata defined in other standard formats. One of these standard formats is the Operational Data Model for metadata, administrative and clinical data in clinical studies. This work suggests a mapping from Operational Data Model to OpenClinica and describes the implementation of a converter to automatically generate OpenClinica conform case report forms based upon metadata in the Operational Data Model.
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Transparent Reporting of Data Quality in Distributed Data Networks
Kahn, Michael G.; Brown, Jeffrey S.; Chun, Alein T.; Davidson, Bruce N.; Meeker, Daniella; Ryan, Patrick B.; Schilling, Lisa M.; Weiskopf, Nicole G.; Williams, Andrew E.; Zozus, Meredith Nahm
2015-01-01
Introduction: Poor data quality can be a serious threat to the validity and generalizability of clinical research findings. The growing availability of electronic administrative and clinical data is accompanied by a growing concern about the quality of these data for observational research and other analytic purposes. Currently, there are no widely accepted guidelines for reporting quality results that would enable investigators and consumers to independently determine if a data source is fit for use to support analytic inferences and reliable evidence generation. Model and Methods: We developed a conceptual model that captures the flow of data from data originator across successive data stewards and finally to the data consumer. This “data lifecycle” model illustrates how data quality issues can result in data being returned back to previous data custodians. We highlight the potential risks of poor data quality on clinical practice and research results. Because of the need to ensure transparent reporting of a data quality issues, we created a unifying data-quality reporting framework and a complementary set of 20 data-quality reporting recommendations for studies that use observational clinical and administrative data for secondary data analysis. We obtained stakeholder input on the perceived value of each recommendation by soliciting public comments via two face-to-face meetings of informatics and comparative-effectiveness investigators, through multiple public webinars targeted to the health services research community, and with an open access online wiki. Recommendations: Our recommendations propose reporting on both general and analysis-specific data quality features. The goals of these recommendations are to improve the reporting of data quality measures for studies that use observational clinical and administrative data, to ensure transparency and consistency in computing data quality measures, and to facilitate best practices and trust in the new clinical discoveries based on secondary use of observational data. PMID:25992385
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Toliver-Sokol, Marisol; Murray, Caitlin B; Wilson, Anna C; Lewandowski, Amy; Palermo, Tonya M
2011-07-01
There is limited research describing the patterns of healthcare utilization in adolescents with chronic pain. This study describes healthcare utilization in a clinical chronic pain sample, and compares the patterns of service use of this group to a community sample with intermittent pain complaints. We also investigated demographic and clinical factors that predicted healthcare visits and medication use in the clinical sample. Data on 117 adolescents (aged 12-18; n = 59 clinical pain sample, n = 58 community) were collected. Caregivers and adolescents reported on sociodemographics, medical visits, current medications, pain, activity limitations, and depression. As hypothesized, the clinical pain sample had higher rates of healthcare consultation on all types of medical visits (general, specialty care, complementary medicine, mental health, OT/PT), and higher medication use compared to the community sample. Regression analyses revealed that higher annual income, greater pain frequency, and higher levels of caregiver-reported activity limitations were associated with a greater number of healthcare visits for the total sample. Within the clinical pain sample, higher pain frequency and greater activity limitations (caregiver report) predicted more specialty care visits. Additionally, higher income and greater levels of depressive symptoms predicted a higher number of prescribed medications. This study contributes to the limited available data on health service and medication use in a clinical chronic pain sample versus a community sample of adolescents. We also identify clinical factors (pain frequency, parent-reported activity limitations, depressive symptoms) and demographic factors (gender, income) associated with healthcare utilization. Copyright © 2011 American Pain Society. Published by Elsevier Inc. All rights reserved.
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The STROBE statement and neuropsychology: lighting the way toward evidence-based practice.
Loring, David W; Bowden, Stephen C
2014-01-01
Reporting appropriate research detail across clinical disciplines is often inconsistent or incomplete. Insufficient report detail reduces confidence in findings, makes study replication more difficult, and decreases the precision of data available for critical review including meta-analysis. In response to these concerns, cooperative attempts across multiple specialties have developed explicit research reporting standards to guide publication detail. These recommendations have been widely adopted by high impact medical journals, but have not yet been widely embraced by neuropsychology. The STROBE Statement (STrengthening the Reporting of Observational studies in Epidemiology) is particularly relevant to neuropsychology since clinical research is often based on non-funded studies of patient samples. In this paper we describe the STROBE Statement and demonstrate how STROBE criteria, applied to reporting of neuropsychological findings, will maintain neuropsychology's position as a leader in quantifying brain-behavior relationships. We also provide specific recommendations for data reporting and disclosure of perceived conflicts of interest that will further enhance reporting transparency for possible perceived sources of bias. In an era in which evidence-based practice assumes an increasingly prominent role, improved reporting standards will promote better patient care, assist in developing quality practice guidelines, and ensure that neuropsychology remains a vigorous discipline in the clinical neurosciences that consciously aspires to high methodological rigor.
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Pharmacists' interventions on clinical asthma outcomes: a systematic review.
Garcia-Cardenas, Victoria; Armour, Carol; Benrimoj, Shalom I; Martinez-Martinez, Fernando; Rotta, Inajara; Fernandez-Llimos, Fernando
2016-04-01
The objective of this systematic review was to evaluate the impact of pharmacists' interventions on clinical asthma outcomes on adult patients and to identify the outcome indicators used.PubMed, Scopus, Web of Science and Scielo were searched. Studies addressing pharmacists' interventions on adult asthma patients reporting clinical asthma outcomes were incorporated.11 clinical outcomes were identified in 21 studies. 10 studies measured the impact of the intervention on asthma control. Randomised controlled trials (RCT) and non-RCTs found positive results in percentages of controlled patients and Asthma Control Questionnaire (ACQ) scores. Discordant results were found for Asthma Control Test results. Asthma severity was assessed in four studies. One RCT found a significant decrease in the percentage of severe patients; two non-RCTs found significant improvements in severity scores. 11 studies reported pulmonary function indicators, showing inconsistent results. Eight studies measured asthma symptoms; three RCTs and four non-RCTs showed significant improvements.RCTs and non-RCTs generated similar results for most outcomes. Based on the evidence generated by RCTs, pharmacists' have a positive impact on the percentage of controlled patients, ACQ scores, severity and symptoms. Future research should report using the core outcome set of indicators established for asthma (PROSPERO CRD42014007019). Copyright ©ERS 2016.
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COLDER CARRAS, MICHELLE; MOJTABAI, RAMIN; FURR-HOLDEN, C. DEBRA; EATON, WILLIAM; CULLEN, BERNADETTE A.M.
2017-01-01
Objective Recent years have witnessed an expansion of Internet- and mobile-phone-based interventions for health promotion, yet few studies have focused on the use of technology by individuals with mental illness. This study examined the extent to which patients at an inner-city community psychiatry clinic had access to information and communications technology (ICT) and how they used those resources. Methods Patients of an outpatient, inner-city community psychiatry program (N = 189) completed a survey that included questions about demographics and ICT use which were adapted from an existing local population-based health survey (community sample, N = 968). Frequencies of ICT use were assessed for the clinic sample and questions common to both the surveys completed by the clinic and community samples were compared using logistic regression. Results Among clinic cases, 105 (55.6%) reported owning or using a computer, 162 (85.7%) reported owning or using a mobile phone, and 112 (59.3%) reported using the Internet. Among those who used mobile phones, the majority reported using them daily; 42% of those who used the Internet reported using it several times per day. Differences in frequency of Internet use between samples were not significant, but clinic participants used the Internet more intensively to email, instant message, access health information, and use social media sites. Conclusions A majority of patients in this community psychiatry clinic sample use ICT. Greater access to and use of the Internet by those with mental illness has important implications for the feasibility and impact of technology-based interventions. PMID:24638044
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An audit about clinical governance skills in Italian medical managers.
Tafuri, S; Martinelli, D; Vece, M M; Prato, R; Germinario, C
2013-01-01
The objective of this study is to describe the knowledge and skills of managers working in health organizations in the Region of Puglia (South of Italy) on the principles and tools of clinical governance. A KAP (Knowledge, Attitudes and Practice) survey was conducted using a questionnaire. The target population of the survey was represented by Hospital Directors and Managers of local health care structures (Primary Care Districts, Public Health Departments, and Mental Health Departments). 92 managers participated at the study (response rate was 90.2%). 98.9% of respondents reported being aware of the concept of clinical governance and believe that clinical governance is an appropriate strategy for the continuous improvement in quality of services. 96.7% of respondents had heard of Evidence Based Practice and 80.6% reported using the method of EBP in nursing practice. The availability of guidelines for consultation was reported by 54.9% of respondents. Of those interviewed, 79.8% knew about Health Technology Assessment. 95.5% reported they have heard of clinical audit and 98.9% knowing the concept of risk management. In our survey, an high value judgment about clinical governance was reported by medical managers. The lower attitudes towards the use of the tools of clinical governance highlights an important discrepancy with respect to knowledge and opinions, which becomes more evident in community care structures. Above and beyond training managers, it is also necessary to change training methods used on all health personnel, which should be oriented towards EBM in order to build an adaptable organizational climate.
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2017-01-01
Background Despite hypertension being a common condition among patients attending primary health care (PHC) clinics, blood pressure (BP) control is often poor. Greater insight into patient-related factors that influence the control of hypertension will assist in the development of an intervention to address the issues identified. Aim The aim of the study was to assess patient-related variables associated with hypertension control among patients attending a peri-urban PHC clinic. Setting The setting for this study was a peri-urban PHC clinic in KwaZulu-Natal. Method This was an observational, descriptive and cross-sectional study with 348 patients selected over a 1-month period. A validated questionnaire was used to collect data on patients’ hypertension knowledge and self-reported adherence, and BP recordings from their medical record were recorded to ascertain control. Results Of the 348 participants, only 49% had good BP control and 44% (152/348) had concurrent diabetes mellitus. The majority of patients had moderate levels of knowledge on hypertension and exhibited moderate adherence. There was a significant relationship between knowledge and reported adherence, between reported adherence and control, but not between reported knowledge and control. Conclusion Despite over 90% of the study population having moderate knowledge, and 62% with moderate reported adherence, BP was well controlled in only less than 50% of the study population. These findings suggest a need to emphasise adherence and explore new ways of approaching adherence. PMID:29113443
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Prevalence of Estimated GFR Reporting Among US Clinical Laboratories
Accetta, Nancy A.; Gladstone, Elisa H.; DiSogra, Charles; Wright, Elizabeth C.; Briggs, Michael; Narva, Andrew S.
2008-01-01
Background Routine laboratory reporting of estimated glomerular filtration rate (eGFR) may help clinicians detect kidney disease. The current national prevalence of eGFR reporting among clinical laboratories is unknown, thus the extent of the situation of laboratories not routinely reporting eGFR with serum creatinine (SCr) results is not quantified. Design Observational analysis. Setting National Kidney Disease Education Program survey of clinical laboratory conducted in 2006-7 by mail, Web, and telephone follow up. Participants A national random sample, 6,350 clinical laboratories, drawn from the Federal Clinical Laboratory Improvement Amendments database and stratified by six major laboratory types/groupings. Predictors Laboratory reports SCr results. Outcomes Reporting eGFR values along with SCr results. Measurements Percent of laboratories reporting eGFR along with reporting SCr, reporting protocol, eGFR formula used, and style of reporting cutoff values. Results Among laboratories reporting SCr, 38.4% report eGFR (physician offices, 25.8%; hospitals, 43.6%; independents, 38.9%; community clinics, 47.2%; health fair/insurance/public health, 45.5%; others, 43.2%). Physician office laboratories have a reporting prevalence lower than other laboratory types (p < 0.001). Among laboratories reporting eGFR, 66.7% do so routinely with all adult SCr determinations; 71.6% use the 4-variable Modification of Diet in Renal Disease Study equation; and 45.3% use the “>60 mL/min/1.73 m2” reporting convention. Independent laboratories are least likely to routinely report eGFR, (50.6%, p < .05) and most likely to report only when specifically requested (45.4%, p < 0.05). High-volume laboratories across all strata are more likely to report eGFR (p < 0.001). Limitations Self-reporting by laboratories, Federal database did not have names of laboratory directors/managers (intended respondents), assumed accuracy of Federal database for sample purposes. Conclusions Routine eGFR reporting with SCr is not yet universal and laboratories vary in their reporting practices. PMID:18676076
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Allen, Elizabeth N; Gomes, Melba; Yevoo, Lucy; Egesah, Omar; Clerk, Christine; Byamugisha, Josaphat; Mbonye, Anthony; Were, Edwin; Mehta, Ushma; Atuyambe, Lynn M
2014-10-31
The World Health Organisation has designed a pregnancy registry to investigate the effect of maternal drug use on pregnancy outcomes in resource-limited settings. In this sentinel surveillance system, detailed health and drug use data are prospectively collected from the first antenatal clinic visit until delivery. Over and above other clinical records, the registry relies on accurate participant reports about the drugs they use. Qualitative methods were incorporated into a pilot registry study during 2010 and 2011 to examine barriers to women reporting these drugs and other exposures at antenatal clinics, and how they might be overcome. Twenty-seven focus group discussions were conducted in Ghana, Kenya and Uganda with a total of 208 women either enrolled in the registry or from its source communities. A question guide was designed to uncover the types of exposure data under- or inaccurately reported at antenatal clinics, the underlying reasons, and how women prefer to be asked questions. Transcripts were analysed thematically. Women said it was important for them to report everything they had used during pregnancy. However, they expressed reservations about revealing their consumption of traditional, over-the-counter medicines and alcohol to antenatal staff because of anticipated negative reactions. Some enrolled participants' improved relationship with registry staff facilitated information sharing and the registry tools helped overcome problems with recall and naming of medicines. Decisions about where women sought care, which influenced medicines used and antenatal clinic attendance, were influenced by pressure within and outside of the formal healthcare system to conform to conflicting behaviours. Conversations also reflected women's responsibilities for producing a healthy baby. Women in this study commonly take traditional medicines in pregnancy, and to a lesser extent over-the-counter medicines and alcohol. The World Health Organisation pregnancy registry shows potential to enhance their reporting of these substances at the antenatal clinic. However, more work is needed to find optimal techniques for eliciting accurate reports, especially where the detail of constituents may never be known. It will also be important to find ways of sustaining such drug exposure surveillance systems in busy antenatal clinics.
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Hamilton, Samina; Bernstein, Aaron B; Blakey, Graham; Fagan, Vivien; Farrow, Tracy; Jordan, Debbie; Seiler, Walther; Shannon, Anna; Gertel, Art
2016-01-01
Interventional clinical studies conducted in the regulated drug research environment are reported using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E3 on the structure and content of clinical study reports (CSRs) published in 1995 and ICH E3 supplementary Questions & Answers (Q & A) published in 2012.Since the ICH guidance documents were published, there has been heightened awareness of the importance of disclosure of clinical study results. The use of the CSR as a key source document to fulfil emerging obligations has resulted in a re-examination of how ICH guidelines are applied in CSR preparation. The dynamic regulatory and modern drug development environments create emerging reporting challenges. Regulatory medical writing and statistical professionals developed Clarity and Openness in Reporting: E3-based (CORE) Reference over a 2-year period. Stakeholders contributing expertise included a global industry association, regulatory agency, patient advocate, academic and Principal Investigator representatives. CORE Reference should help authors navigate relevant guidelines as they create CSR content relevant for today's studies. It offers practical suggestions for developing CSRs that will require minimum redaction and modification prior to public disclosure.CORE Reference comprises a Preface, followed by the actual resource. The Preface clarifies intended use and underlying principles that inform resource utility. The Preface lists references contributing to development of the resource, which broadly fall into 'regulatory' and 'public disclosure' categories. The resource includes ICH E3 guidance text, ICH E3 Q & A 2012-derived guidance text and CORE Reference text, distinguished from one another through the use of shading. Rationale comments are used throughout for clarification purposes.A separate mapping tool comparing ICH E3 sectional structure and CORE Reference sectional structure is also provided.Together, CORE Reference and the mapping tool constitute the user manual. This publication is intended to enhance the use, understanding and dissemination of CORE Reference.The CORE Reference user manual and the associated website (http://www.core-reference.org) should improve the reporting of interventional clinical studies.Periodic updates of CORE Reference are planned to maintain its relevance. CORE Reference was registered with http://www.equator-network.org on 23 March 2015.
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The Added Value of Pathology Review in Vulvar Cancer: Results From a Population-based Cohort Study.
Barbera, Lisa; Gien, Lilian T; Sutradhar, Rinku; Thomas, Gillian; Covens, Al; Elit, Laurie; Fyles, Anthony; Rakovitch, Eileen; Liu, Ying; Khalifa, Mahmoud
2017-03-01
We conducted a population-based patterns of care study of vulvar carcinoma. This paper describes the changes in reporting based on pathology review. This is a retrospective population-based cohort study. We obtained all pathology records available from the provincial cancer registry for primary invasive squamous cell carcinoma of the vulva diagnosed between 1998 and 2007. Pathology reviews were conducted centrally by a group of gynecologic pathologists and were identified during abstraction. Corresponding original reports were matched to pathology review reports based on accession numbers. We compared the reported value for presence/absence of invasion, grade, depth, thickness, size, lymphovascular space invasion, peripheral margin status, and deep margin status in the original and review report. A total of 1011 vulvar resection reports were identified. From these, we identified 316 pairs of original/review reports. Missing data were common but improved in the reviews. In total, 55 (17%) reports had at least 1 change from the original to the review based on presence of invasion, depth, lymphovascular space invasion, or margin. When we included reports where a variable was missing in the original but then completed in the review, there were clinically relevant changes in 210 reports (66%). Vulvar carcinoma is a rare diagnosis and pathology reviews resulted in potentially important clinical changes in a significant proportion of cases. Referral pathologists play an important role in contributing to high-quality clinical decisions.
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Klein, Marguerite A.; Nahin, Richard L.; Messina, Mark J.; Rader, Jeanne I.; Thompson, Lilian U.; Badger, Thomas M.; Dwyer, Johanna T.; Kim, Young S.; Pontzer, Carol H.; Starke-Reed, Pamela E.; Weaver, Connie M.
2010-01-01
The NIH sponsored a scientific workshop, “Soy Protein/Isoflavone Research: Challenges in Designing and Evaluating Intervention Studies,” July 28–29, 2009. The workshop goal was to provide guidance for the next generation of soy protein/isoflavone human research. Session topics included population exposure to soy; the variability of the human response to soy; product composition; methods, tools, and resources available to estimate exposure and protocol adherence; and analytical methods to assess soy in foods and supplements and analytes in biologic fluids and other tissues. The intent of the workshop was to address the quality of soy studies, not the efficacy or safety of soy. Prior NIH workshops and an evidence-based review questioned the quality of data from human soy studies. If clinical studies are pursued, investigators need to ensure that the experimental designs are optimal and the studies properly executed. The workshop participants identified methodological issues that may confound study results and interpretation. Scientifically sound and useful options for dealing with these issues were discussed. The resulting guidance is presented in this document with a brief rationale. The guidance is specific to soy clinical research and does not address nonsoy-related factors that should also be considered in designing and reporting clinical studies. This guidance may be used by investigators, journal editors, study sponsors, and protocol reviewers for a variety of purposes, including designing and implementing trials, reporting results, and interpreting published epidemiological and clinical studies. PMID:20392880
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Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle
2016-01-28
Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov had their results published at least 30 months after study completion. The registration of these observational studies allowed searching other sources (results posted at ClinicalTrials.gov and sponsor website) and obtaining results for half of unpublished studies and 93% of the total target number of participants.
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Teamwork and clinical error reporting among nurses in Korean hospitals.
Hwang, Jee-In; Ahn, Jeonghoon
2015-03-01
To examine levels of teamwork and its relationships with clinical error reporting among Korean hospital nurses. The study employed a cross-sectional survey design. We distributed a questionnaire to 674 nurses in two teaching hospitals in Korea. The questionnaire included items on teamwork and the reporting of clinical errors. We measured teamwork using the Teamwork Perceptions Questionnaire, which has five subscales including team structure, leadership, situation monitoring, mutual support, and communication. Using logistic regression analysis, we determined the relationships between teamwork and error reporting. The response rate was 85.5%. The mean score of teamwork was 3.5 out of 5. At the subscale level, mutual support was rated highest, while leadership was rated lowest. Of the participating nurses, 522 responded that they had experienced at least one clinical error in the last 6 months. Among those, only 53.0% responded that they always or usually reported clinical errors to their managers and/or the patient safety department. Teamwork was significantly associated with better error reporting. Specifically, nurses with a higher team communication score were more likely to report clinical errors to their managers and the patient safety department (odds ratio = 1.82, 95% confidence intervals [1.05, 3.14]). Teamwork was rated as moderate and was positively associated with nurses' error reporting performance. Hospital executives and nurse managers should make substantial efforts to enhance teamwork, which will contribute to encouraging the reporting of errors and improving patient safety. Copyright © 2015. Published by Elsevier B.V.
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Chang, Susan; Vogelbaum, Michael; Lang, Frederick F; Haines, Stephen; Kunwar, Sandeep; Chiocca, E Antonio; Olivi, Alessandro; Quinones-Hinojosa, Alfredo; Parsa, Andrew; Warnick, Ronald
2007-04-01
We present guidelines to standardize the reporting of surgically based neuro-oncology trials. The guidelines are summarized in a checklist format that can be used as a framework from which to construct a surgically based trial. This manuscript follows and is taken in part from GNOSIS: Guidelines for neuro-oncology: Standards for investigational studies-reporting of phase 1 and phase 2 clinical trials [Chang SM, Reynolds SL, Butowski N, Lamborn KR, Buckner JC, Kaplan RS, Bigner DD (2005) Neuro-oncology 7:425-434].
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Martins, Júlia Caetano; Aguiar, Larissa Tavares; Nadeau, Sylvie; Scianni, Aline Alvim; Teixeira-Salmela, Luci Fuscaldi; Faria, Christina Danielli Coelho de Morais
2017-02-13
Self-report physical activity assessment tools are commonly used for the evaluation of physical activity levels in individuals with stroke. A great variety of these tools have been developed and widely used in recent years, which justify the need to examine their measurement properties and clinical utility. Therefore, the main objectives of this systematic review are to examine the measurement properties and clinical utility of self-report measures of physical activity and discuss the strengths and limitations of the identified tools. A systematic review of studies that investigated the measurement properties and/or clinical utility of self-report physical activity assessment tools in stroke will be conducted. Electronic searches will be performed in five databases: Medical Literature Analysis and Retrieval System Online (MEDLINE) (PubMed), Excerpta Medica Database (EMBASE), Physiotherapy Evidence Database (PEDro), Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) and Scientific Electronic Library Online (SciELO), followed by hand searches of the reference lists of the included studies. Two independent reviewers will screen all retrieve titles, abstracts, and full texts, according to the inclusion criteria and will also extract the data. A third reviewer will be referred to solve any disagreement. A descriptive summary of the included studies will contain the design, participants, as well as the characteristics, measurement properties, and clinical utility of the self-report tools. The methodological quality of the studies will be evaluated using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist and the clinical utility of the identified tools will be assessed considering predefined criteria. This systematic review will follow the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) statement. This systematic review will provide an extensive review of the measurement properties and clinical utility of self-report physical activity assessment tools used in individuals with stroke, which would benefit clinicians and researchers. PROSPERO CRD42016037146. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
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2013-01-01
Background The Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) is a 34-item instrument developed to monitor clinically significant change in out-patients. The CORE-OM covers four domains: well-being, problems/symptoms, functioning and risk, and sums up in two total scores: the mean of All items, and the mean of All non-risk items. The aim of this study was to examine the psychometric properties of the Norwegian translation of the CORE-OM. Methods A clinical sample of 527 out-patients from North Norwegian specialist psychiatric services, and a non-clinical sample of 464 persons were obtained. The non-clinical sample was a convenience sample consisting of friends and family of health personnel, and of students of medicine and clinical psychology. Students also reported psychological stress. Exploratory factor analysis (EFA) was employed in half the clinical sample. Confirmatory (CFA) factor analyses modelling the theoretical sub-domains were performed in the remaining half of the clinical sample. Internal consistency, means, and gender and age differences were studied by comparing the clinical and non-clinical samples. Stability, effect of language (Norwegian versus English), and of psychological stress was studied in the sub-sample of students. Finally, cut-off scores were calculated, and distributions of scores were compared between clinical and non-clinical samples, and between students reporting stress or no stress. Results The results indicate that the CORE-OM both measures general (g) psychological distress and sub-domains, of which risk of harm separates most clearly from the g factor. Internal consistency, stability and cut-off scores compared well with the original English version. No, or only negligible, language effects were found. Gender differences were only found for the well-being domain in the non-clinical sample and for the risk domain in the clinical sample. Current patient status explained differences between clinical and non-clinical samples, also when gender and age were controlled for. Students reporting psychological distress during last week scored significantly higher than students reporting no stress. These results further validate the recommended cut-off point of 1 between clinical and non-clinical populations. Conclusions The CORE-OM in Norwegian has psychometric properties at the same level as the English original, and could be recommended for general clinical use. A cut-off point of 1 is recommended for both genders. PMID:23521746
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Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C.; Hobbs, Brian P.; Berry, Donald A.; Pentz, Rebecca D.; Tam, Alda; Hong, Waun K.; Ellis, Lee M.; Abbruzzese, James; Overman, Michael J.
2015-01-01
Purpose The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. Methods We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. Results A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P < .001). Twenty-eight studies (37.8%) reported a total of 65 unplanned end points; 52 (80.0%) of which were not identified as unplanned. Thirty-one (41.9%) and 19 (25.7%) of 74 trials reported a total of 52 unplanned analyses involving primary end points and 33 unplanned analyses involving nonprimary end points, respectively. Studies reported positive unplanned end points and unplanned analyses more frequently than negative outcomes in abstracts (unplanned end points odds ratio, 6.8; P = .002; unplanned analyses odd ratio, 8.4; P = .007). Conclusion Despite public and reviewer access to protocols, selective outcome reporting persists and is a major concern in the reporting of randomized clinical trials. To foster credible evidence-based medicine, additional initiatives are needed to minimize selective reporting. PMID:26304898
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Tsiggos, Nikolaos; Tortopidis, Dimitrios; Hatzikyriakos, Andreas; Menexes, George
2008-07-01
It is unclear whether subjects who report tooth clenching and/or grinding have more noticeable clinical signs of dental attrition, abfractions, and occlusal pits on their natural teeth than subjects who do not report bruxism activity. The purpose of this study was to determine whether there was an association between self-reported (or not reported) bruxism activity and occurrence of dental attrition (anterior, posterior), abfractions, and occlusal pits on natural teeth. One hundred and two volunteer adult Greek subjects (mean age 44.6 +/-5.7 years) were classified into 2 groups (50 self-reported bruxers and 52 nonbruxers) according to 2 inquires regarding grinding and/or clenching of their teeth. Dental attrition (anterior, posterior) was assessed by 2 calibrated experienced examiners on diagnostic casts on a tooth-by-tooth basis, using a previously well established ordinal scale. Abfraction lesions (V-shaped, in the cervical region) and occlusal pits were recorded if these clinical signs were found on at least 2 natural teeth. Statistical comparisons between the 2 groups relative to the distribution of the occurrence of the 4 clinical signs were performed by means of the exact version of the chi-square test. The Fisher's exact test was used for the comparison of percentages. The intra- and interexaminer reliability was assessed by means of the Cohen's kappa coefficient (alpha=.05). The results demonstrated that there was a significant association between self-reported bruxism and occurrence of the 4 clinical signs. Although the 2 groups were significantly different according to the distribution of the 4 clinical signs, the greatest differences occurred for the anterior and posterior attrition signs. In this study, the occurrence of 4 clinical signs (posterior or anterior dental attrition, abfractions, and occlusal pits) was associated with self-reported bruxers. It is suggested that, primarily, signs of dental attrition may differentiate self-reported bruxers from nonbruxer subjects.
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The safety of influenza vaccine in clinically cured leprosy patients in China
Zheng, Yi; Chen, Li; Zou, Jie; Zhu, Zheng-Gang; Zhu, Li; Wan, Jing; Hu, Quan
2018-01-01
ABSTRACT Background: Leprosy is an infectious disease caused by the bacterium Mycobacterium leprae. Influenza vaccine is an important influenza prevention strategy and the preparations used display good safety and tolerability profiles. But the safety of applying influenza vaccine on the clinical cured leprosy patients is unclear. Methods: We conducted an observational clinical study, in Wuhan between November 15, 2016 and March 1, 2017. Two groups of participants ≥50 years of age received a 0.5 ml dose of the inactivated split-virion trivalent influenza vaccine and a follow-up 28 days observation of any solicited and unsolicited adverse events. Results: A total of 134 subjects were included in the study. The total rate of reactogenicity was 5.4% [2/37] in leprosy group and 15.5% [15/ 97] in control group, the difference of reactogenicity between two groups was not significant (p = 0.1522). For solicited injection-sites adverse events (AEs), 12.4% [12/ 97] participants in the control group reported of itching, pain, erythema, swelling or induration, and no participants in leprosy group reported of any solicited injection-sites AEs. For solicited systemic AEs, 7.2% [7 / 97] participants in the control group reported of fever, malaise or headache, and 2.7% [1 / 37] participants in the leprosy group reported of fever, statistic result showed that the difference was not significant (p = 0.4438). Unsolicited AEs was reported by one male aged 76, 4 hours after vaccination administration, his plantar ulcer area began bleeding. All AEs were grade 1 or grade 2, and no recurrence of lepra reaction, AEs leading to early withdrawal from the study, or deaths were reported in this study. Conclusions: To our knowledge, the present study is the first clinical study to evaluate the safety of influenza vaccine in clinically cured leprosy patients. We concluded that clinically cured leprosy patients are relatively safe for influenza vaccine. More importantly, our study make a positive and scientific efforts to eradicate discrimination on leprosy. In our study, we described a patient with plantar ulcer undergoing bleeding for 4 hours after vaccine administration. Based on evidence we have, we interpret that this adverse event may probably associated with vaccine, and patients with ulcer and leprosy need intensive attention after vaccines administration. PMID:29087761
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Shanbhag, Deepti; Graham, Ian D; Harlos, Karen; Haynes, R. Brian; Gabizon, Itzhak; Connolly, Stuart J; Van Spall, Harriette Gillian Christine
2018-01-01
Background The uptake of guideline recommendations that improve heart failure (HF) outcomes remains suboptimal. We reviewed implementation interventions that improve physician adherence to these recommendations, and identified contextual factors associated with implementation success. Methods We searched databases from January 1990 to November 2017 for studies testing interventions to improve uptake of class I HF guidelines. We used the Cochrane Effective Practice and Organisation of Care and Process Redesign frameworks for data extraction. Primary outcomes included: proportion of eligible patients offered guideline-recommended pharmacotherapy, self-care education, left ventricular function assessment and/or intracardiac devices. We reported clinical outcomes when available. Results We included 38 studies. Provider-level interventions (n=13 studies) included audit and feedback, reminders and education. Organisation-level interventions (n=18) included medical records system changes, multidisciplinary teams, clinical pathways and continuity of care. System-level interventions (n=3) included provider/institutional incentives. Four studies assessed multi-level interventions. We could not perform meta-analyses due to statistical/conceptual heterogeneity. Thirty-two studies reported significant improvements in at least one primary outcome. Clinical pathways, multidisciplinary teams and multifaceted interventions were most consistently successful in increasing physician uptake of guidelines. Among randomised controlled trials (RCT) (n=10), pharmacist and nurse-led interventions improved target dose prescriptions. Eleven studies reported clinical outcomes; significant improvements were reported in three, including a clinical pathway, a multidisciplinary team and a multifaceted intervention. Baseline assessment of barriers, staff training, iterative intervention development, leadership commitment and policy/financial incentives were associated with intervention effectiveness. Most studies (n=20) had medium risk of bias; nine RCTs had low risk of bias. Conclusion Our study is limited by the quality and heterogeneity of the primary studies. Clinical pathways, multidisciplinary teams and multifaceted interventions appear to be most consistent in increasing guideline uptake. However, improvements in process outcomes were rarely accompanied by improvements in clinical outcomes. Our work highlights the need for improved research methodology to reliably assess the effectiveness of implementation interventions. PMID:29511005
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Shanbhag, Deepti; Graham, Ian D; Harlos, Karen; Haynes, R Brian; Gabizon, Itzhak; Connolly, Stuart J; Van Spall, Harriette Gillian Christine
2018-03-06
The uptake of guideline recommendations that improve heart failure (HF) outcomes remains suboptimal. We reviewed implementation interventions that improve physician adherence to these recommendations, and identified contextual factors associated with implementation success. We searched databases from January 1990 to November 2017 for studies testing interventions to improve uptake of class I HF guidelines. We used the Cochrane Effective Practice and Organisation of Care and Process Redesign frameworks for data extraction. Primary outcomes included: proportion of eligible patients offered guideline-recommended pharmacotherapy, self-care education, left ventricular function assessment and/or intracardiac devices. We reported clinical outcomes when available. We included 38 studies. Provider-level interventions (n=13 studies) included audit and feedback, reminders and education. Organisation-level interventions (n=18) included medical records system changes, multidisciplinary teams, clinical pathways and continuity of care. System-level interventions (n=3) included provider/institutional incentives. Four studies assessed multi-level interventions. We could not perform meta-analyses due to statistical/conceptual heterogeneity. Thirty-two studies reported significant improvements in at least one primary outcome. Clinical pathways, multidisciplinary teams and multifaceted interventions were most consistently successful in increasing physician uptake of guidelines. Among randomised controlled trials (RCT) (n=10), pharmacist and nurse-led interventions improved target dose prescriptions. Eleven studies reported clinical outcomes; significant improvements were reported in three, including a clinical pathway, a multidisciplinary team and a multifaceted intervention. Baseline assessment of barriers, staff training, iterative intervention development, leadership commitment and policy/financial incentives were associated with intervention effectiveness. Most studies (n=20) had medium risk of bias; nine RCTs had low risk of bias. Our study is limited by the quality and heterogeneity of the primary studies. Clinical pathways, multidisciplinary teams and multifaceted interventions appear to be most consistent in increasing guideline uptake. However, improvements in process outcomes were rarely accompanied by improvements in clinical outcomes. Our work highlights the need for improved research methodology to reliably assess the effectiveness of implementation interventions. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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Oosterhuis, Ingrid; Rolfes, Leàn; Ekhart, Corine; Muller-Hansma, Annemarie; Härmark, Linda
2018-02-01
To make a proper causality assessment of an adverse drug reaction (ADR) report, a certain level of clinical information is necessary. A tool was developed to measure the level of clinical information present in ADR reports. The aim of this study was to test the validity and reliability of the clinical documentation tool (ClinDoc) in an international setting. The tool was developed by a panel of pharmacovigilance experts. It includes four domains: ADR, chronology of the ADR, suspected drug and patient characteristics. The final score categorizes reports into: excellent, well, moderately or poorly documented. In two rounds, eight pharmacovigilance assessors of different countries made a total of 224 assessments using the tool, with the expert panels judgement as a standard. Sensitivity and specificity were calculated. The tool with four outcome-categories demonstrated low sensitivity. A lack of distinctiveness was demonstrated between the categories moderate and well. Results for the second round were re-analysed using three categories. This demonstrated a better validity. This is the first tool to give insight in the level of relevant clinical information present in ADR reports. It can be used internationally to compare reports coming from different reporting methods and different types of reporters in pharmacovigilance.
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Gleacher, Alissa A.; Olin, Serene S.; Nadeem, Erum; Pollock, Michele; Ringle, Vanesa; Bickman, Leonard; Douglas, Susan; Hoagwood, Kimberly
2015-01-01
Measurement feedback systems (MFSs) have been proposed as a means of improving practice. The present study examined the implementation of a MFS, the Contextualized Feedback System (CFS), in two community-based clinic sites. Significant implementation differences across sites provided a basis for examining factors that influenced clinician uptake of CFS. Following the theoretical implementation framework of Aarons, Hurlburt & Horwitz (2011), we coded qualitative data collected from eighteen clinicians (13 from Clinic U and 5 from Clinic R) who participated in semi-structured interviews about their experience with CFS implementation. Results suggest that clinicians at both clinics perceived more barriers than facilitators to CFS implementation. Interestingly, clinicians at the higher implementing clinic reported a higher proportion of barriers to facilitators (3:1 vs. 2:1); however, these clinicians also reported a significantly higher level of organizational and leadership supports for CFS implementation. Implications of these findings are discussed. PMID:25735619
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Law, Michael R; Kawasumi, Yuko; Morgan, Steven G
2011-12-01
Clinical trial registries are public databases created to prospectively document the methods and measures of prescription drug studies and retrospectively collect a summary of results. In 2007 the US government began requiring that researchers register certain studies and report the results on ClinicalTrials.gov, a public database of federally and privately supported trials conducted in the United States and abroad. We found that although the mandate briefly increased trial registrations, 39 percent of trials were still registered late after the mandate's deadline, and only 12 percent of completed studies reported results within a year, as required by the mandate. This result is important because there is evidence of selective reporting even among registered trials. Furthermore, we found that trials funded by industry were more than three times as likely to report results than were trials funded by the National Institutes of Health. Thus, additional enforcement may be required to ensure disclosure of all trial results, leading to a better understanding of drug safety and efficacy. Congress should also reconsider the three-year delay in reporting results for products that have been approved by the Food and Drug Administration and are in use by patients.
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A Large-Scale Study of Misophonia.
Rouw, Romke; Erfanian, Mercede
2018-03-01
We aim to elucidate misophonia, a condition in which particular sounds elicit disproportionally strong aversive reactions. A large online study extensively surveyed personal, developmental, and clinical characteristics of over 300 misophonics. Most participants indicated that their symptoms started in childhood or early teenage years. Severity of misophonic responses increases over time. One third of participants reported having family members with similar symptoms. Half of our participants reported no comorbid clinical conditions, and the other half reported a variety of conditions. Only posttraumatic stress disorder (PTSD) was related to the severity of the misophonic symptoms. Remarkably, half of the participants reported experiencing euphoric, relaxing, and tingling sensations with particular sounds or sights, a relatively unfamiliar phenomenon called autonomous sensory meridian response (ASMR). It is unlikely that another "real" underlying clinical, psychiatric, or psychological disorder can explain away the misophonia. The possible relationship with PTSD and ASMR warrants further investigation. © 2017 Wiley Periodicals, Inc.
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Advantages and Disadvantages of Long-term Proton Pump Inhibitor Use
Kinoshita, Yoshikazu; Ishimura, Norihisa; Ishihara, Shunji
2018-01-01
Proton pump inhibitors (PPIs) potently inhibit gastric acid secretion and are widely used for treatment of acid-related diseases including gastroesophageal reflux disease and secondary prevention of aspirin/NSAID-induced ulcers. Although clinically important adverse effects of PPIs can occur, just as with other drugs, those are not frequently observed during or after administration. Thus, PPIs are regarded as relatively safe and considered to be clinically beneficial. Recently, PPIs have become frequently administered to patients with functional gastrointestinal diseases or primary prevention of drug-related gastroduodenal damage, even though their beneficial effects for those conditions have not been fully confirmed. PPIs tend to be given for conditions in which the necessity of the drug has not been clarified, thus otherwise rare adverse effects are presented as clinically relevant. Although several PPI-related adverse effects have been reported, their clinical relevance is not yet clear, since the evidence reported in those studies is not at a high enough level, as the majority are based on retrospective observational studies and the reported hazard ratios are low. It is important to administer PPIs only for patients who will gain a substantial clinical benefit and to continue to investigate their adverse effects with high quality prospective studies. PMID:29605975
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Advantages and Disadvantages of Long-term Proton Pump Inhibitor Use.
Kinoshita, Yoshikazu; Ishimura, Norihisa; Ishihara, Shunji
2018-04-30
Proton pump inhibitors (PPIs) potently inhibit gastric acid secretion and are widely used for treatment of acid-related diseases including gastroesophageal reflux disease and secondary prevention of aspirin/NSAID-induced ulcers. Although clinically important adverse effects of PPIs can occur, just as with other drugs, those are not frequently observed during or after administration. Thus, PPIs are regarded as relatively safe and considered to be clinically beneficial. Recently, PPIs have become frequently administered to patients with functional gastrointestinal diseases or primary prevention of drug-related gastroduodenal damage, even though their beneficial effects for those conditions have not been fully confirmed. PPIs tend to be given for conditions in which the necessity of the drug has not been clarified, thus otherwise rare adverse effects are presented as clinically relevant. Although several PPI-related adverse effects have been reported, their clinical relevance is not yet clear, since the evidence reported in those studies is not at a high enough level, as the majority are based on retrospective observational studies and the reported hazard ratios are low. It is important to administer PPIs only for patients who will gain a substantial clinical benefit and to continue to investigate their adverse effects with high quality prospective studies.
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Liang, M H
2000-09-01
Although widely used and reported in research for the evaluation of groups, measures of health status and health-related quality of life have had little application in clinical practice for the assessment of individual patients. One of the principal barriers is the demonstration that these measures add clinically significant information to measures of function or symptoms alone. Here, we review the methods for evaluation of construct validity in longitudinal studies and make recommendations for nomenclature, reporting of study results, and future research agenda. Analytical review. The terms "sensitivity" and "responsiveness" have been used interchangeably, and there are few studies that evaluate the extent to which health status or health-related quality-of life measures capture clinically important changes ("responsiveness"). Current methods of evaluating responsiveness are not standardized or evaluated. Approaches for the assessment of a clinically significant or meaningful change are described; rather than normative information, however, standardized transition questions are proposed. They would be reported routinely and as separate axes of description to capture individual perceptions. Research in methods to assess the subject's evaluation of the importance and magnitude of a measured change are critical if health status and health-related quality-of-life measures are to have an impact on patient care.
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Roberts, Rachel M; Robins, Tamara; Gannoni, Anne F; Tapp, Heather
2014-01-01
This study provides a description of psychological late effects among a heterogeneous cohort of pediatric cancer survivors (N = 70) attending the South Australian Late-effects Clinic. Survivors reported more problems on the Strengths and Difficulties Questionnaire and the Child Behavior Checklist compared to normative data but no differences in Sluggish Cognitive Tempo scores. Forty-six percent of the sample reported school difficulties, and 12% of the sample age older than 15 reported smoking. Late-effects clinics should continue to monitor psychological well-being and health behaviors. Further research is recommended to determine whether sluggish cognitive tempo is a useful concept for the assessment of survivors.
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Bolton, Wade
2011-06-01
The utility of functional cell mediated immune assays in the assessment of immune response or immunogenicity is increasing significantly as we search for surrogates to determine vaccine efficacy or therapeutic response. No definitive reports to date have demonstrated that CMI assays in human clinical trials correlate with clinical outcome, although animal and non human primate studies have reported surrogacy in varying degrees. This report discusses the approaches identified, their advantages and disadvantages, and their justification for inclusion in the clinical trial setting.
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A Review of Clinical Data for Currently Approved Hysteroscopic Sterilization Procedures
Basinski, Cindy M
2010-01-01
Two hysteroscopic permanent sterilization procedures are approved for use in the United States: Essure® Permanent Birth Control System (Conceptus Incorporated, Mountain View, CA) and Adiana® Permanent Contraception (Hologic, Inc., Bedford, MA). This review compares the clinical trial data for these procedures. A notable difference is the resultant clinical pregnancy risk. The clinical trials for the Essure procedure have reported no pregnancies in 643 relying women in the 9 years since initiation of the studies. The clinical trial for the Adiana procedure has reported 12 pregnancies in 570 relying women in nearly 5 years of collected data. Other clinical outcome parameters concerning Essure and Adiana are examined in this review. PMID:21364861
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Reverse smokers's and changes in oral mucosa. Department of Sucre, Colombia.
Alvarez Gómez, Gloria-J; Alvarez Martínez, Efraín; Jiménez Gómez, Raúl; Mosquera Silva, Yolanda; Gaviria Núñez, Angela María; Garcés Agudelo, Adriana; Alonso Duque, Alexander; Zabala Castaño, Alexander; Echeverri González, Elizabeth; Isaac Millán, Melissa; Ramírez Ossa, Diana
2008-01-01
This work is intended to establish the prevalence of reverse smokers at the villages of Hato Nuevo, San Francisco and Cayo de Palma, Department of Sucre, Colombia, characterizing their socio-culture conditions, clinical and histological changes in the oral mucosa. A descriptive study was done through a home to home inquiry to select the people with inclusion criteria for a posterior clinical test and a biopsy of the affected oral mucosa. Reverse smokers's prevalence was from the 15%, mainly women (p<0.001) with an age average of 59.3 years. The lesions were classified clinically in mild, moderate and severe changes. Tongue moderate lesions presented the higher frequency (80%), followed by severe lesions on palate (74%). Oral cancer prevalence was 10.8% in the San Francisco village and 18.2% in Cayo de Palma village, no new cases were reported in Hato Nuevo village. This was the highest prevalence reported in comparison with other studies with similar population. The clinical and histological findings agree with the reported in literature, no relation was found between the degree of clinical severity and the dysplasia itself. Cases of oral submucous fibrosis-like lesions were found, which had never been reported in Latin America. Further studies are required in order to decrease the morbidity for this habit and to identify other related risk factors.
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NASA Astrophysics Data System (ADS)
Guha, Daipayan; Jakubovic, Raphael; Gupta, Shaurya; Yang, Victor X. D.
2017-02-01
Computer-assisted navigation (CAN) may guide spinal surgeries, reliably reducing screw breach rates. Definitions of screw breach, if reported, vary widely across studies. Absolute quantitative error is theoretically a more precise and generalizable metric of navigation accuracy, but has been computed variably and reported in fewer than 25% of clinical studies of CAN-guided pedicle screw accuracy. We reviewed a prospectively-collected series of 209 pedicle screws placed with CAN guidance to characterize the correlation between clinical pedicle screw accuracy, based on postoperative imaging, and absolute quantitative navigation accuracy. We found that acceptable screw accuracy was achieved for significantly fewer screws based on 2mm grade vs. Heary grade, particularly in the lumbar spine. Inter-rater agreement was good for the Heary classification and moderate for the 2mm grade, significantly greater among radiologists than surgeon raters. Mean absolute translational/angular accuracies were 1.75mm/3.13° and 1.20mm/3.64° in the axial and sagittal planes, respectively. There was no correlation between clinical and absolute navigation accuracy, in part because surgeons appear to compensate for perceived translational navigation error by adjusting screw medialization angle. Future studies of navigation accuracy should therefore report absolute translational and angular errors. Clinical screw grades based on post-operative imaging, if reported, may be more reliable if performed in multiple by radiologist raters.
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Thompson, Carl; Stapley, Sally
2011-07-01
Despite the growing popularity of decision making in nursing curricula, the effectiveness of educational interventions to improve nursing judgement and decision making is unknown. We sought to synthesise and summarise the comparative evidence for educational interventions to improve nursing judgements and clinical decisions. A systematic review. Electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, CINAHL and PsycINFO, Social Sciences Citation Index, OpenSIGLE conference proceedings and hand searching nursing journals. Studies published since 1960, reporting any educational intervention that aimed to improve nurses' clinical judgements or decision making were included. Studies were assessed for relevance and quality. Data extracted included study design; educational setting; the nature of participants; whether the study was concerned with the clinical application of skills or the application of theory; the type of decision targeted by the intervention (e.g. diagnostic reasoning) and whether the evaluation of the intervention focused on efficacy or effectiveness. A narrative approach to study synthesis was used due to heterogeneity in interventions, study samples, outcomes and settings and incomplete reporting of effect sizes. From 5262 initial citations 24 studies were included in the review. A variety of educational approaches were reported. Study quality and content reporting was generally poor. Pedagogical theories were widely used but use of decision theory (with the exception of subjective expected utility theory implicit in decision analysis) was rare. The effectiveness and efficacy of interventions was mixed. Educational interventions to improve nurses' judgements and decisions are complex and the evidence from comparative studies does little to reduce the uncertainty about 'what works'. Nurse educators need to pay attention to decision, as well as pedagogical, theory in the design of interventions. Study design and reporting requires improvement to maximise the information contained in reports of educational interventions. Copyright © 2011 Elsevier Ltd. All rights reserved.
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Manifest dream content as a possible predictor of suicidality.
Glucksman, Myron L
2014-12-01
The prediction of suicidal intent remains a clinical problem. This presentation illustrates that a distinction may be made between the manifest dream reports of patients who are potentially or acutely suicidal and those who are not. A review of the literature reveals that the manifest dream reports of clinically depressed, non-suicidal individuals differ from those who are depressed and acutely suicidal. The former contain themes of loss, disappointment, rejection, helplessness, hopelessness, failure, and death. The latter contain themes of dying, death, destruction, and violence directed toward the dreamer or others, as well as hopelessness and helplessness. The author collected manifest dream reports from three clinically depressed, non-suicidal patients and three clinically depressed, potentially or acutely suicidal patients. There are apparent differences between the themes of manifest dream reports in the clinically depressed, non-suicidal patients and the clinically depressed, potentially or acutely suicidal patients. The former contain themes of death, loss, rejection, vulnerability, hopelessness, and helplessness. The latter contain themes of active harm or violence (specifically toward the dreamer), dying or being dead, aloneness, vulnerability, hopelessness, and helplessness. Clinical cases and corresponding manifest dream reports are presented. Although this is a preliminary study, it is possible that manifest dream content may be used as one of the predictors of suicidality, in conjunction with latent dream content, diagnosis, life circumstance, and clinical status.
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CDC-reported assisted reproductive technology live-birth rates may mislead the public.
Kushnir, Vitaly A; Choi, Jennifer; Darmon, Sarah K; Albertini, David F; Barad, David H; Gleicher, Norbert
2017-08-01
The Centre for Disease Control and Prevention (CDC) publicly reports assisted reproductive technology live-birth rates (LBR) for each US fertility clinic under legal mandate. The 2014 CDC report excluded 35,406 of 184,527 (19.2%) autologous assisted reproductive technology cycles that involved embryo or oocyte banking from LBR calculations. This study calculated 2014 total clinic LBR for all patients utilizing autologous oocytes two ways: including all initiated assisted reproductive technology cycles or excluding banking cycles, as done by the CDC. The main limitation of this analysis is the CDC report did not differentiate between cycles involving long-term banking of embryos or oocytes for fertility preservation from cycles involving short-term embryo banking. Twenty-seven of 458 (6%) clinics reported over 40% of autologous cycles involved banking, collectively performing 12% of all US assisted reproductive technology cycles. LBR in these outlier clinics calculated by the CDC method, was higher than the other 94% of clinics (33.1% versus 31.1%). However, recalculated LBR including banking cycles in the outlier clinics was lower than the other 94% of clinics (15.5% versus 26.6%). LBR calculated by the two methods increasingly diverged based on proportion of banking cycles performed by each clinic reaching 4.5-fold, thereby, potentially misleading the public. Copyright © 2017 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.
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Effectiveness of teaching quality improvement to clinicians: a systematic review.
Boonyasai, Romsai T; Windish, Donna M; Chakraborti, Chayan; Feldman, Leonard S; Rubin, Haya R; Bass, Eric B
2007-09-05
Accreditation requirements mandate teaching quality improvement (QI) concepts to medical trainees, yet little is known about the effectiveness of teaching QI. To perform a systematic review of the effectiveness of published QI curricula for clinicians and to determine whether teaching methods influence the effectiveness of such curricula. The electronic literature databases of MEDLINE, EMBASE, CINAHL, and ERIC were searched for English-language articles published between January 1, 1980, and April 30, 2007. Experts in the field of QI were queried about relevant studies. Two independent reviewers selected studies for inclusion if the curriculum taught QI principles to clinicians and the evaluation used a comparative study design. Information about the features of each curriculum, its use of 9 principles of adult learning, and the type of educational and clinical outcomes were extracted. The relationship between the outcomes and the number of educational principles used was assessed. Of 39 studies that met eligibility criteria, 31 described team-based projects; 37 combined didactic instruction with experiential learning. The median number of adult learning principles used was 7 (range, 2-8). Evaluations included 22 controlled trials (8 randomized and 14 nonrandomized) and 17 pre/post or time series studies. Fourteen studies described educational outcomes (attitudes, knowledge, or skills or behaviors) and 28 studies described clinical process or patient outcomes. Nine of the 10 studies that evaluated knowledge reported only positive effects but only 2 of these described a validated assessment tool. The 6 assessments of attitudes found mixed results. Four of the 6 studies on skill or behavior outcomes reported only positive effects. Eight of the 28 studies of clinical outcomes reported only beneficial effects. Controlled studies were more likely than other studies to report mixed or null effects. Only 4 studies evaluated both educational and clinical outcomes, providing limited evidence that educational outcomes influence the clinical effectiveness of the interventions. Most published QI curricula apply sound adult learning principles and demonstrate improvement in learners' knowledge or confidence to perform QI. Additional studies are needed to determine whether educational methods have meaningful clinical benefits.
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Individual and Composite Study Endpoints: Separating the Wheat from the Chaff
Goldberg, Robert; Gore, Joel M.; Barton, Bruce; Gurwitz, Jerry
2014-01-01
We provide an overview of the individual and combined clinical endpoints and patient reported outcomes typically used in clinical trials and prospective epidemiological investigations. We discuss the strengths and limitations associated with the utilization of aggregated study endpoints and surrogate measures of important clinical endpoints and patient-centered outcomes. We hope that the points raised in this overview will lead to the collection of clinically rich, relevant, measurable, and cost-efficient study outcomes. PMID:24486289
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[Do pediatricians identify adverse drug reactions even when they do not report them?
Morales-Ríos, Olga; Jasso-Gutiérrez, Luis; Garduño-Espinosa, Juan; Olivar-López, Víctor; Muñoz-Hernández, Onofre
Spontaneous notification depends on the ability of pediatricians to identify adverse drug reactions (ADRs) along with their habit of reporting these incidents. During the years 2008 and 2009, the frequency of reports of ADRs to the Electronic Program of Pharmacovigilance (SISFAR) in the Hospital Infantil of Mexico Federico Gomez (HIMFG) was low (0.44% and 0.20%, respectively). Because of the above, the ability of pediatricians from the Emergency Department (ED) to identify ADRs using the clinical chart review was evaluated in 2010 in this study. A descriptive, observational, cross-sectional retrospective study was conducted in the ED from March 1 to August 31. ADRs were classified and quantified as "ADRs identified by pediatricians" when there was evidence in the clinical chart that pediatricians associated a clinical sign, symptom and laboratory value with an ADR. The numbers of notifications reported in SISFAR were quantified. Descriptive analysis was done using SPSS v.18. Considering patients who were admitted to the ED, the frequency of ADRs was 21.8%. The frequency of ADRs identified by physicians in clinical charts was 86%. The pharmacist detected 14% of ADRs. The frequency of ADRs reported by physicians was 6.1%. Although identification of ADRs in the clinical charts by pediatricians was high, it is possible that some ADRs were undetected. Because underreporting was very high, it is necessary to take actions to improve the reporting process. Copyright © 2015. Publicado por Masson Doyma México S.A.
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Research and Clinical Center for Child Development Annual Report, 1999-2000, No. 23.
ERIC Educational Resources Information Center
Chen, Shing-Jen, Ed.; Fujino, Yuki, Ed.
This annual report presents several articles related to the work of the Clinical Center for Child Development at Hokkaido University in Sapporo, Japan. The articles are: (1) "Intrinsic Musicality: Rhythm and Prosody in Infant-Directed Voices" (Niki Powers); (2) "Movable Cognitive Studies with a Portable, Telemetric Near-Infrared…
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Medical Student Use of Objectives in Basic Science and Clinical Instruction.
ERIC Educational Resources Information Center
And Others; Mast, Terrill A.
1980-01-01
A study that investigated the long-term use of instructional objectives by medical students taking basic science and clinical courses is reported. Focus is on the extent and manner in which the objectives were used and factors that influenced their use. Students reported heavier usage earlier in the curriculum. (Author/JMD)
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Research and Clinical Center for Child Development Annual Report, 1997-1998, No. 21.
ERIC Educational Resources Information Center
Chen, Shing-Jen, Ed.; Furutsuka, Takashi, Ed.; Shirotani, Yukari, Ed.
This annual report discusses several topics related to the work of the Clinical Center for Child Development at Hokkaido University in Sapporo, Japan. The articles are: (1) "The Study of Mothers' Parenting Practices with Child's Withdrawn Behaviors and Temperament" (Sueko Toda); (2) "Structure, Developmental Change, and Sex…
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[Geographic expansion of hantavirus pulmonary syndrome in Argentina. The southernest case report].
Bellomo, Carla; Nudelman, Julio; Kwaszka, Roberto; Vazquez, Gabriela; Cantoni, Gustavo; Weinzettel, Barbara; Larrieu, Edmundo G; Padula, Paula
2009-01-01
Since 1995 more than 1000 cases of hantavirus pulmonary syndrome (HPS) were reported in Argentina, a severe disease and often fatal to humans. Most cases were associated with Andes virus (AND) that caused few events of person-to-person transmission. Several lineages of pathogenic AND viruses have been described, including AND South, hosted by the rodent Oligoryzomys longicaudatus which affects the Patagonian region of Argentina and Chile. We studied the clinical and epidemiological characteristics of a HPS case. The objective was to describe the clinical presentation of the case, its epidemiology, the likely site of infection, the viral variant implicated and its relationship with the closest reported cases. We carried out the clinical follow up, serological and molecular diagnosis and the epidemiological research, including a rodent reservoir study. The clinical presentation of the case was the classical and moderate, caused by AND South virus. Its viral nucleotide sequence was compared with cases from Southern Argentina and Chile. This case was found to be the most Southern (48 degrees 46' 1.2'' S; 70 degrees 15' O) case reported and involved a new Argentinean province.
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Validation of self-reported information on dental caries in a birth cohort at 18 years of age.
Silva, Alexandre Emidio Ribeiro; Menezes, Ana Maria Baptista; Assunção, Maria Cecília Formoso; Gonçalves, Helen; Demarco, Flávio Fernando; Vargas-Ferreira, Fabiana; Peres, Marco Aurélio
2014-01-01
Estimate the prevalence of dental caries based on clinical examinations and self-reports and compare differences in the prevalence and effect measures between the two methods among 18-year-olds belonging to a 1993 birth cohort in the city of Pelotas, Brazil. Data on self-reported caries, socio-demographic aspects and oral health behaviour were collected using a questionnaire administered to adolescents aged 18 years (n = 4041). Clinical caries was evaluated (n = 1014) by a dentist who had undergone training and calibration exercises. Prevalence rates of clinical and self-reported caries, sensitivity, specificity, positive and negative predictive values, absolute and relative bias, and inflation factors were calculated. Prevalence ratios of dental caries were estimated for each risk factor. The prevalence of clinical and self-reported caries (DMFT>1) was 66.5% (95%CI: 63.6%-69.3%) and 60.3% (95%CI: 58.8%-61.8%), respectively. Self-reports underestimated the prevalence of dental caries by 9.3% in comparison to clinical evaluations. The analysis of the validity of self-reports regarding the DMFT index indicated high sensitivity (81.8%; 95%CI: 78.7%-84.7%) and specificity (78.1%; 95%CI: 73.3%-82.4%) in relation to the gold standard (clinical evaluation). Both the clinical and self-reported evaluations were associated with gender, schooling and self-rated oral health. Clinical dental caries was associated with visits to the dentist in the previous year. Self-reported dental caries was associated with daily tooth brushing frequency. Based on the present findings, self-reported information on dental caries using the DMFT index requires further studies prior to its use in the analysis of risk factors, but is valid for population-based health surveys with the aim of planning and monitoring oral health actions directed at adolescents.
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Evans, Jonathan P; Smith, Chris D; Fine, Nicola F; Porter, Ian; Gangannagaripalli, Jaheeda; Goodwin, Victoria A; Valderas, Jose M
2018-04-01
Clinical rating systems are used as outcome measures in clinical trials and attempt to gauge the patient's view of his or her own health. The choice of clinical rating system should be supported by its performance against established quality standards. A search strategy was developed to identify all studies that reported the use of clinical rating systems in the elbow literature. The strategy was run from inception in Medline Embase and CINHAL. Data extraction identified the date of publication, country of data collection, pathology assessed, and the outcome measure used. We identified 980 studies that reported clinical rating system use. Seventy-two separate rating systems were identified. Forty-one percent of studies used ≥2 separate measures. Overall, 54% of studies used the Mayo Elbow Performance Score (MEPS). For arthroplasty, 82% used MEPS, 17% used Disabilities of Arm, Shoulder and Hand (DASH), and 7% used QuickDASH. For trauma, 66.7% used MEPS, 32% used DASH, and 23% used the Morrey Score. For tendinopathy, 31% used DASH, 23% used Patient-Rated Tennis Elbow Evaluation (PRTEE), and 13% used MEPS. Over time, there was an increased proportional use of the MEPS, DASH, QuickDASH, PRTEE, and the Oxford Elbow Score. This study identified a wide choice and usage of clinical rating systems in the elbow literature. Numerous studies reported measures without a history of either a specific pathology or cross-cultural validation. Interpretability and comparison of outcomes is dependent on the unification of outcome measure choice. This was not demonstrated currently. Copyright © 2018 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.
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[MUC4 research progress in tumor molecular markers].
Zhu, Hua; You, Jinhui
2014-02-01
Mucin antigen 4 (MUC4) is a molecular marker for some malignant tumors for early tumor diagnosis, prognosis and targeted therapy. It provides a new research direction in tumor diagnosis and treatment that will have a wide application prospect. In recent years, there has been a large number of research reports on the basic and clini-a wide application prospect. In recent years, there has been a large number of research reports on the basic and clinical studies about MUC4, but the molecular imaging study about MUC4 is seldom reported. In this paper the recentcal studies about MUC4, but the molecular imaging study about MUC4 is seldom reported. In this paper the recent research about MUC4 on basic and clinical studies is briefly reviewed, and it is expected to promote the development of tumor molecular imaging.
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Ellegaard, Mai-Britt Bjørklund; Grau, Cai; Zachariae, Robert; Jensen, Anders Bonde
2017-08-01
Follow-up after breast cancer treatment is standard due to the risk of development of new primary cancers and recurrent disease. The aim of the present study was to evaluate a standard follow-up program in an oncological department by assessing: (1) Symptoms or signs of new primary cancer or recurrent disease, (2) Disease- and treatment-related physical and psychosocial side or late effects, and (3) relevant actions by oncology staff. In a cross-sectional study, 194 women who came for follow-up visit after treatment for primary surgery were included. The clinical oncologists registered symptoms and signs of recurrent disease or new primary cancer. Side or late effects were both assessed by patient and the clinical oncologists. Loco-regional or distant signs of recurrent disease were suspected in eight (5%) patients. Further examinations revealed no disease recurrence. Most patients (93%) reported some degree of side or late effects. Statistically significant more side or late effects were reported by the women (average: 6.9) than registered by the clinical oncologists (average: 2.4), p < 0.001. The three most often patient-reported side or late effects were hot flushes (35%), fatigue (32%), and sleep disturbance (31%). None of the scheduled or additional visits resulted in detection of recurrent disease. Furthermore, the majority of patients reported side or late effects. Statistically significant more women reported side or late effects than registered by the clinical oncologists. This suggests the need for rethinking of the follow-up programs with more emphasis upon side or late effects of the treatment.
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Tice, Debra G.; Carroll, Kelly A.; Bhatt, Karishma H.; Belknap, Steven M.; Mai, David; Gipson, Heather J.; West, Dennis P.
2013-01-01
Background The impact of non-accrued clinical research (NACR) represents an important economic burden that is under consideration as the U.S. Department of Health and Human Services looks into reforming the regulations governing IRB review. NACR refers to clinical research projects that fail to enroll subjects. A delineation of the issues surrounding NACR is expected to enhance subject accrual and to minimize occurrence of NACR. The authors assessed demographics, characteristics, and reasons for NACR at an academic medical center, including time trends, funding source, research team (principal investigator, department), IRB resource utilization (IRB level of review, number of required IRB reviews, initial IRB turn-around time, and duration of NACR). Methods The authors analyzed data from 848 clinical research study closures during 2010 and 2011 to determine proportion, incidence, and characteristics of NACR. Studies with subject enrollment during the same time period were used as a comparative measure. Results Data from 704 (83.0%) study closures reported enrollment of 1 or more subjects while 144 (17.0 %) reported NACR (zero enrollment). PI-reported reasons for NACR included: 32 (22.2%) contract or funding issues; 43 (30.0%) insufficient study-dedicated resources; 41 (28.4%) recruitment issues; 17 (11.8%) sponsor-initiated study closure and 11 (7.6%) were “other/reason unreported”. Conclusions NACR is not uncommon, affecting about one in six clinical research projects in the study population and reported to be more common in some other institutions. The complex and fluid nature of research conduct, non-realistic enrollment goals, and delays in both the approval and/or accrual processes contribute to NACR. Results suggest some simple strategies that investigators and institutions may use to reduce NACR, including careful feasibility assessment, reduction of institutional delays, and prompt initiation of subject accrual for multi-center studies using competitive enrollment. Institutional action to support investigators in the conduct clinical research is also encouraged to reduce likelihood of NACR. PMID:23671544
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Tice, Debra G; Carroll, Kelly A; Bhatt, Karishma H; Belknap, Steven M; Mai, David; Gipson, Heather J; West, Dennis P
2013-06-01
The impact of non-accrued clinical research (NACR) represents an important economic burden that is under consideration as the U.S. Department of Health and Human Services looks into reforming the regulations governing IRB review. NACR refers to clinical research projects that fail to enroll subjects. A delineation of the issues surrounding NACR is expected to enhance subject accrual and to minimize occurrence of NACR. The authors assessed demographics, characteristics, and reasons for NACR at an academic medical center, including time trends, funding source, research team (principal investigator, department), IRB resource utilization (IRB level of review, number of required IRB reviews, initial IRB turn-around time, and duration of NACR). The authors analyzed data from 848 clinical research study closures during 2010 and 2011 to determine proportion, incidence, and characteristics of NACR. Studies with subject enrollment during the same time period were used as a comparative measure. Data from 704 (83.0%) study closures reported enrollment of 1 or more subjects while 144 (17.0 %) reported NACR (zero enrollment). PI-reported reasons for NACR included: 32 (22.2%) contract or funding issues; 43 (30.0%) insufficient study-dedicated resources; 41 (28.4%) recruitment issues; 17 (11.8%) sponsor-initiated study closure and 11 (7.6%) were "other/reason unreported". NACR is not uncommon, affecting about one in six clinical research projects in the study population and reported to be more common in some other institutions. The complex and fluid nature of research conduct, non-realistic enrollment goals, and delays in both the approval and/or accrual processes contribute to NACR. Results suggest some simple strategies that investigators and institutions may use to reduce NACR, including careful feasibility assessment, reduction of institutional delays, and prompt initiation of subject accrual for multi-center studies using competitive enrollment. Institutional action to support investigators in the conduct clinical research is also encouraged to reduce likelihood of NACR.
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Pollak, Kathryn I; Nagy, Paul; Bigger, John; Bilheimer, Alicia; Lyna, Pauline; Gao, Xiaomei; Lancaster, Michael; Watkins, R Chip; Johnson, Fred; Batish, Sanjay; Skelton, Joseph A; Armstrong, Sarah
2016-02-01
Studies indicate needed improvement in clinician communication and patient satisfaction. Motivational interviewing (MI) helps promote patient behavior change and improves satisfaction. In this pilot study, we tested a coaching intervention to teach MI to all clinic staff to improve clinician and patient satisfaction. We included four clinics (n=29 staff members). In the intervention clinics (one primary care and one pediatric obesity-focused), we trained all clinic staff in MI through meetings as a group seven times, directly observing clinicians in practice 4-10 times, and providing real-time feedback on MI techniques. In all clinics, we assessed patient satisfaction via anonymous surveys and also assessed clinician burnout and self-rated MI skills. Clinicians in the intervention clinics reported improvements in burnout scores, self-rated MI skills, and perceived cohesion whereas clinicians in the control clinic reported worse scores. Patient satisfaction improved in the intervention clinics more than in the control clinics. This is the first study to find some benefit of training an entire clinic staff in MI via a coaching model. It might help to train staff in MI to improve clinician satisfaction, team cohesion, perceived skills, and patient satisfaction. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
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Zheng, Sarah Y; Dhruva, Sanket S; Redberg, Rita F
2017-08-15
High-risk medical devices often undergo modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements. To characterize the quality of the clinical studies and data (strength of evidence) used to support FDA approval of panel-track supplements (a type of PMA supplement pathway that is used for significant changes in a device or indication for use and always requires clinical data). Descriptive study of clinical studies supporting panel-track supplements approved by the FDA between April 19, 2006, and October 9, 2015. Panel-track supplement approval. Methodological quality of studies including randomization, blinding, type of controls, clinical vs surrogate primary end points, use of post hoc analyses, and reporting of age and sex. Eighty-three clinical studies supported the approval of 78 panel-track supplements, with 71 panel-track supplements (91%) supported by a single study. Of the 83 studies, 37 (45%) were randomized clinical trials and 25 (30%) were blinded. The median number of patients per study was 185 (interquartile range, 75-305), and the median follow-up duration was 180 days (interquartile range, 84-270 days). There were a total of 150 primary end points (mean [SD], 1.8 [1.2] per study), and 57 primary end points (38%) were compared with controls. Of primary end points with controls, 6 (11%) were retrospective controls and 51 (89%) were active controls. One hundred twenty-one primary end points (81%) were surrogate end points. Thirty-three studies (40%) did not report age and 25 (30%) did not report sex for all enrolled patients. The FDA required postapproval studies for 29 of 78 (37%) panel-track supplements. Among clinical studies used to support FDA approval of high-risk medical device modifications, fewer than half were randomized, blinded, or controlled, and most primary outcomes were based on surrogate end points. These findings suggest that the quality of studies and data evaluated to support approval by the FDA of modifications of high-risk devices should be improved.
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The ClinicalTrials.gov results database--update and key issues.
Zarin, Deborah A; Tse, Tony; Williams, Rebecca J; Califf, Robert M; Ide, Nicholas C
2011-03-03
The ClinicalTrials.gov trial registry was expanded in 2008 to include a database for reporting summary results. We summarize the structure and contents of the results database, provide an update of relevant policies, and show how the data can be used to gain insight into the state of clinical research. We analyzed ClinicalTrials.gov data that were publicly available between September 2009 and September 2010. As of September 27, 2010, ClinicalTrials.gov received approximately 330 new and 2000 revised registrations each week, along with 30 new and 80 revised results submissions. We characterized the 79,413 registry and 2178 results of trial records available as of September 2010. From a sample cohort of results records, 78 of 150 (52%) had associated publications within 2 years after posting. Of results records available publicly, 20% reported more than two primary outcome measures and 5% reported more than five. Of a sample of 100 registry record outcome measures, 61% lacked specificity in describing the metric used in the planned analysis. In a sample of 700 results records, the mean number of different analysis populations per study group was 2.5 (median, 1; range, 1 to 25). Of these trials, 24% reported results for 90% or less of their participants. ClinicalTrials.gov provides access to study results not otherwise available to the public. Although the database allows examination of various aspects of ongoing and completed clinical trials, its ultimate usefulness depends on the research community to submit accurate, informative data.
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IMPROVING THE REPORTING OF THERAPEUTIC EXERCISE INTERVENTIONS IN REHABILITATION RESEARCH.
Page, Phil; Hoogenboom, Barb; Voight, Michael
2017-04-01
The foundation of evidence-based practice lies in clinical research, which is based on the utilization of the scientific method. The scientific method requires that all details of the experiment be provided in publications to support replication of the study in order to evaluate and validate the results. More importantly, clinical research can only be translated into practice when researchers provide explicit details of the study. Too often, rehabilitation exercise intervention studies lack the appropriate detail to allow clinicians to replicate the exercise protocol in their patient populations. Therefore, the purpose of this clinical commentary is to provide guidelines for optimal reporting of therapeutic exercise interventions in rehabilitation research. 5.
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Nurses’ Use of Race in Clinical Decision Making
Sellers, Sherrill L.; Moss, Melissa E.; Calzone, Kathleen; Abdallah, Khadijah E.; Jenkins, Jean F.; Bonham, Vence L.
2017-01-01
Purpose To examine nurses’ self-reported use of race in clinical evaluation. Design This cross-sectional study analyzed data collected from three separate studies using the Genetics and Genomics in Nursing Practice Survey, which includes items about use of race and genomic information in nursing practice. The Racial Attributes in Clinical Evaluation (RACE) scale was used to measure explicit clinical use of race among nurses from across the United States. Methods Multivariate regression analysis was used to examine associations between RACE score and individual-level characteristics and beliefs in 5,733 registered nurses. Findings Analysis revealed significant relationships between RACE score and nurses’ race and ethnicity, educational level, and views on the clinical importance of patient demographic characteristics. Asian nurses reported RACE scores 1.41 points higher than White nurses (p < .001), and Black nurses reported RACE scores 0.55 points higher than White nurses (p < .05). Compared to diploma-level nurses, the baccalaureate-level nurses reported 0.69 points higher RACE scores (p < .05), master’s-level nurses reported 1.63 points higher RACE scores (p < .001), and doctorate-level nurses reported 1.77 points higher RACE scores (p < .01). In terms of clinical importance of patient characteristics, patient race and ethnicity corresponded to a 0.54-point increase in RACE score (p < .001), patient genes to a 0.21-point increase in RACE score (p < .001), patient family history to a 0.15-point increase in RACE score (p < .01), and patient age to a 0.19-point increase in RACE score (p < .001). Conclusions Higher reported use of race among minority nurses may be due, in part, to differential levels of racial self-awareness. A relatively linear positive relationship between level of nursing degree nursing education and use of race suggests that a stronger foundation of knowledge about genetic ancestry, population genetics and the concept “race” and genetic ancestry may increase in clinical decision making could allow nurses to more appropriately use of race in clinical care. Integrating patient demographic characteristics into clinical decisions is an important component of nursing practice. Clinical Relevance Registered nurses provide care for diverse racial and ethnic patient populations and stand on the front line of clinical care, making them essential for reducing racial and ethnic disparities in healthcare delivery. Exploring registered nurses’ individual-level characteristics and clinical use of race may provide a more comprehensive understanding of specific training needs and inform nursing education and practice. PMID:27676232
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Simel, David L; Rennie, Drummond; Bossuyt, Patrick M M
2008-06-01
The Standards for Reporting of Diagnostic Accuracy (STARD) statement provided guidelines for investigators conducting diagnostic accuracy studies. We reviewed each item in the statement for its applicability to clinical examination diagnostic accuracy research, viewing each discrete aspect of the history and physical examination as a diagnostic test. Nonsystematic review of the STARD statement. Two former STARD Group participants and 1 editor of a journal series on clinical examination research reviewed each STARD item. Suggested interpretations and comments were shared to develop consensus. The STARD Statement applies generally well to clinical examination diagnostic accuracy studies. Three items are the most important for clinical examination diagnostic accuracy studies, and investigators should pay particular attention to their requirements: describe carefully the patient recruitment process, describe participant sampling and address if patients were from a consecutive series, and describe whether the clinicians were masked to the reference standard tests and whether the interpretation of the reference standard test was masked to the clinical examination components or overall clinical impression. The consideration of these and the other STARD items in clinical examination diagnostic research studies would improve the quality of investigations and strengthen conclusions reached by practicing clinicians. The STARD statement provides a very useful framework for diagnostic accuracy studies. The group correctly anticipated that there would be nuances applicable to studies of the clinical examination. We offer guidance that should enhance their usefulness to investigators embarking on original studies of a patient's history and physical examination.
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Powers, John H.; Patrick, Donald L.; Walton, Marc K.; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B.
2017-01-01
A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients’ health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient’s health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment—Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of ClinRO assessments used as end points in clinical trials. Applying good measurement practices to ClinRO assessment development and evaluation will lead to more efficient and accurate measurement of treatment effects. This is important beyond regulatory approval in that it provides evidence for the uptake of new interventions into clinical practice and provides justification to payers for reimbursement on the basis of the clearly demonstrated added value of the new intervention. PMID:28212963
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Powers, John H; Patrick, Donald L; Walton, Marc K; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B
2017-01-01
A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients' health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient's health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment-Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of ClinRO assessments used as end points in clinical trials. Applying good measurement practices to ClinRO assessment development and evaluation will lead to more efficient and accurate measurement of treatment effects. This is important beyond regulatory approval in that it provides evidence for the uptake of new interventions into clinical practice and provides justification to payers for reimbursement on the basis of the clearly demonstrated added value of the new intervention. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
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Bellon-Harn, Monica L
2005-01-01
Prader-Willi Syndrome (PWS) is reported in 1 in 10,000-15,000 individuals. Unfortunately, many cases are missed due to clinicians' lack of familiarity with the syndrome as well as clinical and laboratory diagnostic criteria. Although common clinical characteristics are reported, variety exists in the nature and severity of dysfunction associated with PWS. Case studies can provide information to understand relationships between phenotypic characteristics and genetic inheritance, which can in turn lead to effective clinical management. The purpose of this case study was to describe the characteristics of a child with PWS due to maternal uniparental disomy inheritance pattern and to describe clinical management and treatment outcomes. The reader will obtain information about: (1) the genetic inheritance patterns and clinical characteristics of Prader-Willi Syndrome, (2) genotypic/phenotypic relationships specific to Prader-Willi Syndrome, and (3) clinical implications, management, and outcomes in a case description of a child with PWS due to maternal uniparental disomy inheritance pattern.
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Zheng, X; Chu, H; Cong, Y; Deng, Y; Long, Y; Zhu, Y; Pohl, D; Fried, M; Dai, N; Fox, M
2015-08-01
Many patients complain of abdominal symptoms with dairy products; however, clinical and psychosocial factors associated with self-reported lactose intolerance (SLI) have not been assessed in large studies. In particular, data are lacking from lactase deficient populations. This prospective cohort study assessed the prevalence of, and risk factors for, SLI in Chinese patients attending a gastroenterology clinic. Consecutive patients completed questionnaires to assess digestive health (Rome III), psychological state (HADS), life event stress (LES), food intake, and quality-of-life (SF-8). A representative sample completed genetic studies and hydrogen breath testing (HBT) at the clinically relevant dose of 20 g lactose. SLI was present in 411/910 (45%) clinic patients with functional abdominal symptoms. The genotype in all subjects was C/C-13910. A small number of novel SNPs in lactase promoter region were identified, including C/T-13908 which appeared to confer lactase persistence. Over half of the patients (54%) completed the 20 g lactose HBT with 58% (285/492) reporting typical symptoms. Positive and negative predictive values of SLI for abdominal symptoms during HBT were 60% and 44%, respectively. Psychological state and stress were not associated with SLI in clinic patients. SLI impacted on physical quality-of-life and was associated with reduced ingestion of dairy products, legumes, and dried fruit (p ≤ 0.05). In a lactase deficient population, approximately half of patients attending clinic with functional gastrointestinal symptoms reported intolerance to dairy products; however, SLI did not predict findings on 20 g lactose HBT. Independent of psychosocial factors, SLI impacted on quality-of-life and impacted on food choices with restrictions not limited to dairy products. © 2015 John Wiley & Sons Ltd.
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Matthys, Heinrich; Lizogub, Victor G; Funk, Petra; Malek, Fathi A
2010-12-01
Health-related quality of life (HRQL) and patient-reported outcome (PRO) have become important outcome parameters for the evaluation of medical treatment within clinical trials and, furthermore, to evaluate efficiency in clinical practice. We therefore report further exploratory results of an already reported dose-finding study with EPs 7630 tablets, now focussing on HRQL and PRO. A total of 406 adults with acute bronchitis were randomly assigned to one of four parallel treatment groups (placebo, 30 mg, 60 mg or 90 mg EPs 7630 daily). HRQL and PRO were assessed by questionnaires as secondary outcome measures at each study visit or daily in the patient's diary. At day 7, the patient-reported outcome measures were significantly more improved in all the three EPs 7630 groups compared to placebo (EQ-5D and EQ VAS, SF-12: physical score, impact of patient's sickness, duration of activity limitation, patient-reported treatment outcome, satisfaction with treatment). In conclusion, a statistically significant and clinically relevant improvement of HRQL/PRO compared to placebo was shown in all the three EPs 7630 groups.
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Development of Pain Endpoint Models for Use in Prostate Cancer Clinical Trials and Drug Approval
2016-10-01
consensus meeting, with input from investigators in the Prostate Cancer Clinical Trials Consortium, FDA Office of Oncology Drug Products, FDA Study...Cancer Clinical Trials Consortium, FDA Office of Oncology Drug Products, FDA Study Endpoint and Label Development Team, and FDA Division of...Abstract. American Society of Clinical Oncology . Chicago IL, June 1-5, 2013. INVENTIONS, PATENTS AND LICENSES None 11 REPORTABLE OUTCOMES
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The development of an incident event reporting system for nursing students.
Chiou, Shwu-Fen; Huang, Ean-Wen; Chuang, Jen-Hsiang
2009-01-01
Incident events may occur when nursing students are present in the clinical setting. Their inexperience and unfamiliarity with clinical practice put them at risk for making mistakes that could potentially harm patients and themselves. However, there are deficiencies with incident event reporting systems, including incomplete data and delayed reports. The purpose of this study was to develop an incident event reporting system for nursing students in clinical settings and evaluate its effectiveness. This study was undertaken in three phases. In the first phase, a literature review and focus groups were used to develop the architecture of the reporting system. In the second phase, the reporting system was implemented. Data from incident events that involved nursing students were collected for a 12-month period. In the third phase, a pre-post trial was undertaken to evaluate the performance of the reporting system. The ASP.NET software and Microsoft Access 2003 were used to create an interactive web-based interface and design a database for the reporting system. Email notifications alerted the nursing student's teacher when an incident event was reported. One year after installing the reporting system, the number of reported incident events increased tenfold. However, the time to report the incident event and the time required to complete the reporting procedures were shorter than before implementation of the reporting system. The incident event reporting system appeared to be effective in more comprehensively reporting the number of incident events and shorten the time required for reporting them compared to traditional written reports.
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Case report: clinical and postmortem findings in four cows with rib fracture.
Braun, Ueli; Warislohner, Sonja; Hetzel, Udo; Nuss, Karl
2017-02-06
Published reports of rib fractures in adult cattle are limited to the occurrence of chronic rib swellings caused by calluses, which are unremarkable from a clinical standpoint, whereas studies identifying clinical signs of rib fractures were not found in a literature search. This report describes the clinical and postmortem findings in four cows with rib fractures. The 13th rib was fractured in three cows and the 11th rib in the remaining cow; three fractures were on the right and one on the left side. Clinical and postmortem findings varied considerably, and percussion of the rib cage elicited a pain response in only one cow. One cow had generalised peritonitis because of perforation of the rumen by the fractured rib. One cow was recumbent because of pain and became a downer cow, and two other cows had bronchopneumonia, which was a sequel to osteomyelitis of the fracture site in one. In the absence of a history of trauma, the diagnosis of rib fracture based on clinical signs alone is difficult. Although rib fractures undoubtedly are very painful, the four cases described in this report suggest that they are difficult to diagnose in cattle because associated clinical signs are nonspecific.
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Advance modern medicine with clinical case reports.
Wáng, Yì-Xiáng J
2014-12-01
Randomized clinical trial (RCT) can fail to demonstrate the richness of individual patient characteristics. Given the unpredictable nature of medicine, a patient may present in an unusual way, have a strange new pathology, or react to a medical intervention in a manner not seen before. The publication of these novelties as case reports is a fundamental way of conveying medical knowledge. Throughout history there have been famous case studies that shaped the way we view health and disease. Case reports can have the following functions: (I) descriptions of new diseases; (II) study of mechanisms; (III) discovery new therapies; (IV) recognition of side effects; and (V) education. Before submitting a case report, it is worthwhile to refer to the Case Report Check Sheet described by Green and Johnson [2006].
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Basch, Ethan; Abernethy, Amy P; Mullins, C Daniel; Reeve, Bryce B; Smith, Mary Lou; Coons, Stephen Joel; Sloan, Jeff; Wenzel, Keith; Chauhan, Cynthia; Eppard, Wayland; Frank, Elizabeth S; Lipscomb, Joseph; Raymond, Stephen A; Spencer, Merianne; Tunis, Sean
2012-12-01
Examining the patient's subjective experience in prospective clinical comparative effectiveness research (CER) of oncology treatments or process interventions is essential for informing decision making. Patient-reported outcome (PRO) measures are the standard tools for directly eliciting the patient experience. There are currently no widely accepted standards for developing or implementing PRO measures in CER. Recommendations for the design and implementation of PRO measures in CER were developed via a standardized process including multistakeholder interviews, a technical working group, and public comments. Key recommendations are to include assessment of patient-reported symptoms as well as health-related quality of life in all prospective clinical CER studies in adult oncology; to identify symptoms relevant to a particular study population and context based on literature review and/or qualitative and quantitative methods; to assure that PRO measures used are valid, reliable, and sensitive in a comparable population (measures particularly recommended include EORTC QLQ-C30, FACT, MDASI, PRO-CTCAE, and PROMIS); to collect PRO data electronically whenever possible; to employ methods that minimize missing patient reports and include a plan for analyzing and reporting missing PRO data; to report the proportion of responders and cumulative distribution of responses in addition to mean changes in scores; and to publish results of PRO analyses simultaneously with other clinical outcomes. Twelve core symptoms are recommended for consideration in studies in advanced or metastatic cancers. Adherence to methodologic standards for the selection, implementation, and analysis/reporting of PRO measures will lead to an understanding of the patient experience that informs better decisions by patients, providers, regulators, and payers.
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Miller, Fiona Alice; Hayeems, Robin Zoe; Li, Li; Bytautas, Jessica Peace
2012-08-01
Even as debate continues about the putative obligation to proactively report genetic research results to study participants, there is an increasing need to attend to the obligations that might cascade from any initial report. We conducted an international, quasi-experimental survey of researchers involved in autism spectrum disorders (ASD) and cystic fibrosis (CF) genetics to explore perceived obligations to ensure updated information or relevant clinical care subsequent to any initial communication of research results, and factors influencing these attitudes. 5-point Likert scales of dis/agreement were analyzed using descriptive and multivariate statistics. Of the 343 respondents (44% response rate), large majorities agreed that in general and in a variety of hypothetical research contexts, research teams that report results should ensure that participants gain subsequent access to updated information (74-83%) and implicated clinical services (79-87%). At the same time, researchers perceived barriers restricting access to relevant clinical care, though this was significantly more pronounced (P<0.001) for ASD (64%) than CF (34%). In the multivariate model, endorsement of cascading obligations was positively associated with researcher characteristics (eg, clinical role/training) and attitudes (eg, perceived initial reporting obligation), and negatively associated with the initial report of less scientifically robust hypothetical results, but unaffected by perceived or hypothetical barriers to care. These results suggest that researchers strongly endorse information and care-based obligations that cascade from the initial report of research results to study participants. In addition, they raise challenging questions about how any cascading obligations are to be met, especially where access challenges are already prevalent.
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Perceived Barriers to Clinic Appointments for Adolescents with Sickle Cell Disease
Crosby, Lori E.; Modi, Avani C.; Lemanek, Kathleen L.; Guilfoyle, Shanna M.; Kalinyak, Karen A.; Mitchell, Monica J.
2009-01-01
Purpose The purpose of the study was to examine perceived barriers to clinic attendance and strategies to overcome these barriers for adolescents with sickle cell disease (SCD). Materials and Methods This was a two-phased study which utilized focus groups (n = 13) and individual semi-structured interviews (n = 32) with adolescent patients (aged 13–21 years) from three pediatric sickle cell clinics in the Mid-west. Results Adolescents identified competing activities, health status, patient-provider relationships, adverse clinic experiences, and forgetting as barriers to clinic attendance. Calendars/reminders and parent reminders were the most commonly reported strategies to facilitate clinic attendance. Adolescents also reported the need for flexible scheduling and improved patient-provider communication. Discussion Adolescents with SCD and their families may benefit from on-going education about the importance of attending routine clinic visits. Adherence to clinic appointments for adolescents may be enhanced by developing interventions to decrease forgetting (e.g., phone call reminders, text-messaging) and increase patient satisfaction with clinic visits. Scheduling appointments to accommodate busy schedules/scheduling conflicts (e.g., late clinic hours), providing teen-friendly clinic environments and utilizing technology may also facilitate attendance. PMID:19636266
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Reproducibility of clinical research in critical care: a scoping review.
Niven, Daniel J; McCormick, T Jared; Straus, Sharon E; Hemmelgarn, Brenda R; Jeffs, Lianne; Barnes, Tavish R M; Stelfox, Henry T
2018-02-21
The ability to reproduce experiments is a defining principle of science. Reproducibility of clinical research has received relatively little scientific attention. However, it is important as it may inform clinical practice, research agendas, and the design of future studies. We used scoping review methods to examine reproducibility within a cohort of randomized trials examining clinical critical care research and published in the top general medical and critical care journals. To identify relevant clinical practices, we searched the New England Journal of Medicine, The Lancet, and JAMA for randomized trials published up to April 2016. To identify a comprehensive set of studies for these practices, included articles informed secondary searches within other high-impact medical and specialty journals. We included late-phase randomized controlled trials examining therapeutic clinical practices in adults admitted to general medical-surgical or specialty intensive care units (ICUs). Included articles were classified using a reproducibility framework. An original study was the first to evaluate a clinical practice. A reproduction attempt re-evaluated that practice in a new set of participants. Overall, 158 practices were examined in 275 included articles. A reproduction attempt was identified for 66 practices (42%, 95% CI 33-50%). Original studies reported larger effects than reproduction attempts (primary endpoint, risk difference 16.0%, 95% CI 11.6-20.5% vs. 8.4%, 95% CI 6.0-10.8%, P = 0.003). More than half of clinical practices with a reproduction attempt demonstrated effects that were inconsistent with the original study (56%, 95% CI 42-68%), among which a large number were reported to be efficacious in the original study and to lack efficacy in the reproduction attempt (34%, 95% CI 19-52%). Two practices reported to be efficacious in the original study were found to be harmful in the reproduction attempt. A minority of critical care practices with research published in high-profile journals were evaluated for reproducibility; less than half had reproducible effects.
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Jia, Chi-yu; Wang, Yun-chuan; Bai, Feng
2006-02-01
To investigate the quality of reports of clinical results concerning burn injury, in order to raise the standard of clinical study of burn care in accordance to the standard of evidence-based medicine (EBM), with the aim of improving clinical research in burn care of this country. All the papers of clinical study published in Chinese Journal of Burns (CJB) from 2000 to 2004 were evaluated according to EBM standard. There were 89 papers about clinical trials published in the past 5 years, in which 43 (48.3%) of the studies were carried out with random control trials (RCT), and 46 (51.7%) were clinical control trials (CCT). RCT papers increased year by year, while the number of CCT papers fluctuated greatly. The disparity in the quality of research was found as follows. In all the RCT and CCT papers, blinded research was adopted only in 5 papers (5.6%). Strict diagnostic standard including inclusion and exclusion standards were reported in 53 articles (59.6%). The comparison with baselines was not provided in 64 articles (71.9%). P value was given in 10 papers but statistical method was not mentioned (11.2%). Follow-up visits and lost information were only recorded in 2 articles, but no detailed follow-up visiting data were provided. Side effects were reported in 10 articles (11.2%). There were analysis and explanation of mixed interfering factors only in 5 papers (5.6%). There was no explanation of the evaluation of sample size in any one paper. In summary, the literature concerning clinical studies published in CJB in the past five years has become more extensive. However, the present study indicates that many clinical trials are not designed and ethical consideration is often missing. Therefore, it is deemed imperative to improve the quality of the clinical studies by improving the planning of the protocols of the study and statistical analysis of the research results in future.
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Code of Federal Regulations, 2010 CFR
2010-04-01
... steps have not been taken in the design, conduct, reporting, and analysis of the studies to minimize... INVESTIGATORS § 54.1 Purpose. (a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in... clinical studies to determine whether the applications are approvable under the statutory requirements. FDA...
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Code of Federal Regulations, 2011 CFR
2011-04-01
... steps have not been taken in the design, conduct, reporting, and analysis of the studies to minimize... INVESTIGATORS § 54.1 Purpose. (a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in... clinical studies to determine whether the applications are approvable under the statutory requirements. FDA...
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Claassens, Lily; van Meerbeeck, Jan; Coens, Corneel; Quinten, Chantal; Ghislain, Irina; Sloan, Elizabeth K.; Wang, Xin Shelly; Velikova, Galina; Bottomley, Andrew
2011-01-01
Purpose This study is an update of a systematic review of health-related quality-of-life (HRQOL) methodology reporting in non–small-cell lung cancer (NSCLC) randomized controlled trials (RCTs). The objective was to evaluate HRQOL methodology reporting over the last decade and its benefit for clinical decision making. Methods A MEDLINE systematic literature review was performed. Eligible RCTs implemented patient-reported HRQOL assessments and regular oncology treatments for newly diagnosed adult patients with NSCLC. Included studies were published in English from August 2002 to July 2010. Two independent reviewers evaluated all included RCTs. Results Fifty-three RCTs were assessed. Of the 53 RCTs, 81% reported that there was no significant difference in overall survival (OS). However, 50% of RCTs that were unable to find OS differences reported a significant difference in HRQOL scores. The quality of HRQOL reporting has improved; both reporting of clinically significant differences and statistical testing of HRQOL have improved. A European Organisation for Research and Treatment of Cancer HRQOL questionnaire was used in 57% of the studies. However, reporting of HRQOL hypotheses and rationales for choosing HRQOL instruments were significantly less than before 2002 (P < .05). Conclusion The number of NSCLC RCTs incorporating HRQOL assessments has considerably increased. HRQOL continues to demonstrate its importance in RCTs, especially in those studies in which no OS difference is found. Despite the improved quality of HRQOL methodology reporting, certain aspects remain underrepresented. Our findings suggest need for an international standardization of HRQOL reporting similar to the CONSORT guidelines for clinical findings. PMID:21464420
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Platelet-Rich Fibrin and Soft Tissue Wound Healing: A Systematic Review.
Miron, Richard J; Fujioka-Kobayashi, Masako; Bishara, Mark; Zhang, Yufeng; Hernandez, Maria; Choukroun, Joseph
2017-02-01
The growing multidisciplinary field of tissue engineering aims at predictably regenerating, enhancing, or replacing damaged or missing tissues for a variety of conditions caused by trauma, disease, and old age. One area of research that has gained tremendous awareness in recent years is that of platelet-rich fibrin (PRF), which has been utilized across a wide variety of medical fields for the regeneration of soft tissues. This systematic review gathered all the currently available in vitro, in vivo, and clinical literature utilizing PRF for soft tissue regeneration, augmentation, and/or wound healing. In total, 164 publications met the original search criteria, with a total of 48 publications meeting inclusion criteria (kappa score = 94%). These studies were divided into 7 in vitro, 11 in vivo, and 31 clinical studies. In summary, 6 out of 7 (85.7%) and 11 out of 11 (100%) of the in vitro and in vivo studies, respectively, demonstrated a statistically significant advantage for combining PRF to their regenerative therapies. Out of the remaining 31 clinical studies, a total of 8 reported the effects of PRF in a randomized clinical trial, with 5 additional studies (13 total) reporting appropriate controls. In those clinical studies, 9 out of the 13 studies (69.2%) demonstrated a statistically relevant positive outcome for the primary endpoints measured. In total, 18 studies (58% of clinical studies) reported positive wound-healing events associated with the use of PRF, despite using controls. Furthermore, 27 of the 31 clinical studies (87%) supported the use of PRF for soft tissue regeneration and wound healing for a variety of procedures in medicine and dentistry. In conclusion, the results from the present systematic review highlight the positive effects of PRF on wound healing after regenerative therapy for the management of various soft tissue defects found in medicine and dentistry.
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Preparing physical therapy students for the role of clinical educator: a case study report.
Dockter, Mary; Roller, Joellen; Eckert, Jody
2013-01-01
The purpose of this case report was to describe an innovative model for transforming physical therapist students into clinical instructors with the use of a pro bono clinic. This model may assist other academic programs in creating effective approaches to transition entry-level students into future quality clinical instructors. Third year physical therapist students served as clinical instructors for second year students. Peer and self assessments were collected to assess intended objectives. Second year students were made more aware of the role of the clinical instructor and were able to evaluate the effectiveness of clinical teaching and third year students appreciated the impact of clinical teaching and increased their desire to become clinical instructors in the future. Student self and peer assessments reveal that this experiential model is an effective way of transitioning entry-level physical therapist students into the role of clinical instructor.
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The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices.
Barker, Jordan P; Simon, Stephen D; Dubin, Jonathan
2017-05-03
The purpose of this investigation was to examine the methodology of clinical trials used by the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of high-risk orthopaedic devices approved between 2001 and 2015. Utilizing the FDA's online public database, this systematic review audited study design and methodological variables intended to minimize bias and confounding. An additional analysis of blinding as well as the Checklist to Evaluate a Report of a Nonpharmacological Trial (CLEAR NPT) was applied to the randomized controlled trials (RCTs). Of the 49 studies, 46 (94%) were prospective and 37 (76%) were randomized. Forty-seven (96%) of the studies were controlled in some form. Of 35 studies that reported it, blinding was utilized in 21 (60%), of which 8 (38%) were reported as single-blinded and 13 (62%) were reported as double-blinded. Of the 37 RCTs, outcome assessors were clearly blinded in 6 (16%), whereas 15 (41%) were deemed impossible to blind as implants could be readily discerned on imaging. When the CLEAR NPT was applied to the 37 RCTs, >70% of studies were deemed "unclear" in describing generation of allocation sequences, treatment allocation concealment, and adequate blinding of participants and outcome assessors. This study manifests the highly variable reporting and strength of clinical research methodology accepted by the FDA to approve high-risk orthopaedic devices.
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Huang, Yang; Lowe, Henry J.; Hersh, William R.
2003-01-01
Objective: Despite the advantages of structured data entry, much of the patient record is still stored as unstructured or semistructured narrative text. The issue of representing clinical document content remains problematic. The authors' prior work using an automated UMLS document indexing system has been encouraging but has been affected by the generally low indexing precision of such systems. In an effort to improve precision, the authors have developed a context-sensitive document indexing model to calculate the optimal subset of UMLS source vocabularies used to index each document section. This pilot study was performed to evaluate the utility of this indexing approach on a set of clinical radiology reports. Design: A set of clinical radiology reports that had been indexed manually using UMLS concept descriptors was indexed automatically by the SAPHIRE indexing engine. Using the data generated by this process the authors developed a system that simulated indexing, at the document section level, of the same document set using many permutations of a subset of the UMLS constituent vocabularies. Measurements: The precision and recall scores generated by simulated indexing for each permutation of two or three UMLS constituent vocabularies were determined. Results: While there was considerable variation in precision and recall values across the different subtypes of radiology reports, the overall effect of this indexing strategy using the best combination of two or three UMLS constituent vocabularies was an improvement in precision without significant impact of recall. Conclusion: In this pilot study a contextual indexing strategy improved overall precision in a set of clinical radiology reports. PMID:12925544
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Huang, Yang; Lowe, Henry J; Hersh, William R
2003-01-01
Despite the advantages of structured data entry, much of the patient record is still stored as unstructured or semistructured narrative text. The issue of representing clinical document content remains problematic. The authors' prior work using an automated UMLS document indexing system has been encouraging but has been affected by the generally low indexing precision of such systems. In an effort to improve precision, the authors have developed a context-sensitive document indexing model to calculate the optimal subset of UMLS source vocabularies used to index each document section. This pilot study was performed to evaluate the utility of this indexing approach on a set of clinical radiology reports. A set of clinical radiology reports that had been indexed manually using UMLS concept descriptors was indexed automatically by the SAPHIRE indexing engine. Using the data generated by this process the authors developed a system that simulated indexing, at the document section level, of the same document set using many permutations of a subset of the UMLS constituent vocabularies. The precision and recall scores generated by simulated indexing for each permutation of two or three UMLS constituent vocabularies were determined. While there was considerable variation in precision and recall values across the different subtypes of radiology reports, the overall effect of this indexing strategy using the best combination of two or three UMLS constituent vocabularies was an improvement in precision without significant impact of recall. In this pilot study a contextual indexing strategy improved overall precision in a set of clinical radiology reports.
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National Assessment of Clinical Education of Allied Health Manpower: Volume IV: Bibliography.
ERIC Educational Resources Information Center
Booz Allen and Hamilton, Inc., Washington, DC.
The document is the last volume of a four-part report of a study conducted to evaluate and assess the national state of clinical education and training of allied health manpower. It presents a bibliography of all significant clinical education materials, documentary materials and ongoing studies, through August 30, 1973 but after 1965. The…
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Read, Thomas E
To prospectively evaluate the effect of introducing a clinical skills "passport" on medical students' reporting of their experience with basic clinical skills. A prospective longitudinal intervention study was conducted. Medical students were administered a questionnaire at the conclusion of their 12-week surgery clerkship regarding their experience with 15 clinical skills, inquiring whether they had "learned on surgery clerkship", "learned before surgery clerkship", or "not learned". Preintervention baseline data were obtained for 2 consecutive academic years (n = 213 students). In the third year, students (n = 124) were given a clinical skills passport to document performance of 8 of the 15 skills under the supervision of a surgical resident or faculty member. After excluding from analysis those students who learned a skill before their surgery clerkship, the fraction of students who reported learning clinical skills during their surgery clerkship before and after the introduction of the clinical skills passport was compared using Fisher exact test and chi-squared test, where appropriate (p ≤ 0.003 was considered significant; Bonferroni correction for multiple comparisons). Washington University School of Medicine. A total of 337 medical students completing the junior surgery clerkship over a 3-year period were included in the study. All 337 students completed a survey. Considering each skill individually, survey response rate was 5045/5055 (99.8%). Combining all responses for all skills, the fraction of students reporting that skills were learned on the surgery clerkship increased after the introduction of the clinical skills passport (1498/1938 [77%] preintervention vs. 974/1109 [88%] postintervention, p < 0.0001, chi square). After the introduction of the clinical skills passport, the fraction of students reporting that a skill was "learned on surgery clerkship" significantly increased for the 8 skills listed on the passport (1026/1699 [83%] preintervention vs. 685/714 [96%] postintervention, p < 0.0001, chi square), but did not increase for the 7 skills not listed on the passport (472/695 [68%] preintervention vs. 289/395 [73%] postintervention, p = 0.08, chi square). Considering each skill individually, after the introduction of the clinical skills passport, the fraction of students reporting that a skill was "learned on surgery clerkship" significantly increased for 4/15 skills (all listed on the clinical passport) and decreased for 0/15 skills (p < 0.003, Fisher exact test, 2 tailed). Institution of a clinical skills passport system during a surgery clerkship increased medical student reporting of their performance of basic clinical skills. Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.
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Guidelines for the Design and Conduct of Clinical Studies in Knee Articular Cartilage Repair
Mithoefer, Kai; Saris, Daniel B.F.; Farr, Jack; Kon, Elizaveta; Zaslav, Kenneth; Cole, Brian J.; Ranstam, Jonas; Yao, Jian; Shive, Matthew; Levine, David; Dalemans, Wilfried; Brittberg, Mats
2011-01-01
Objective: To summarize current clinical research practice and develop methodological standards for objective scientific evaluation of knee cartilage repair procedures and products. Design: A comprehensive literature review was performed of high-level original studies providing information relevant for the design of clinical studies on articular cartilage repair in the knee. Analysis of cartilage repair publications and synopses of ongoing trials were used to identify important criteria for the design, reporting, and interpretation of studies in this field. Results: Current literature reflects the methodological limitations of the scientific evidence available for articular cartilage repair. However, clinical trial databases of ongoing trials document a trend suggesting improved study designs and clinical evaluation methodology. Based on the current scientific information and standards of clinical care, detailed methodological recommendations were developed for the statistical study design, patient recruitment, control group considerations, study endpoint definition, documentation of results, use of validated patient-reported outcome instruments, and inclusion and exclusion criteria for the design and conduct of scientifically sound cartilage repair study protocols. A consensus statement among the International Cartilage Repair Society (ICRS) and contributing authors experienced in clinical trial design and implementation was achieved. Conclusions: High-quality clinical research methodology is critical for the optimal evaluation of current and new cartilage repair technologies. In addition to generally applicable principles for orthopedic study design, specific criteria and considerations apply to cartilage repair studies. Systematic application of these criteria and considerations can facilitate study designs that are scientifically rigorous, ethical, practical, and appropriate for the question(s) being addressed in any given cartilage repair research project. PMID:26069574
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Bovine thrombin safety reporting: an example of study design and publication bias.
Crean, Sheila; Michels, Shannon L; Moschella, Kevin; Reynolds, Matthew W
2010-01-01
Bovine thrombin, a popular hemostat and sealant since 1945, has recently been subjected to clinical trial testing due to reformulations in 1998. We sought to compare adverse event rates of early observational studies with those of later interventional trials. A MEDLINE-based literature search in publications that report safety in bovine thrombin exposed surgical patients was extracted and reviewed. In 38 studies, about half were case reports and 31.5% were interventional trials. In case reports, 41% of authors reported severe coagulopathic adverse events. In contrast, whereas blood complications were common in large trials, no association of harm was established for bovine thrombin product exposure and/or immunization. In this review, later clinical trials failed to reproduce the common and severe coagulopathy predicted by earlier observational studies in bovine exposed patients. This example illustrates that perceptions of safety can change as a function of study design, even for a widely adopted, well established biologic such as thrombin. Caution must be exercised in interpreting evidence from observational studies alone.
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Ho, Siew Ching; Chong, Huey Yi; Chaiyakunapruk, Nathorn; Tangiisuran, Balamurugan; Jacob, Sabrina Anne
2016-03-15
Medication non-adherence is one of the major challenges in treating patients with depression. This systematic review aims to determine the clinical and economic outcomes of non-adherence in depression. A systematic search was performed across the following databases: PubMed, EMBASE, DARE, CINAHL, PsycINFO, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews; from database inception to March 31, 2015. Studies must report on the association between adherence and outcomes, and English full texts needed to be available. The quality of each study was assessed using the Newcastle-Ottawa scale. A total of 11 articles were included, with eight reporting on clinical outcomes, two reporting on economic outcomes, and one reporting on both. The majority of studies were retrospective cohort studies. The mean quality of all included studies was 7, with a range from 3 to 9. Results clearly indicate that patients who were non-adherent were more likely to experience increased risks of relapse and/or recurrence, emergency department visits, and hospitalization rates; increased severity of depression, and a decrease in response and remission rates. The worsening of clinical outcomes in patients who were non-adherent subsequently translated to an increase in healthcare utilization and charges. No standardized adherence measurement tools were used, and few studies looked at the economic impact of non-adherence in depression. There is a strong association between non-adherence to antidepressants and a worsening of patients' clinical and economic outcomes. Cost-effective interventions should be directed to this group of patients to improve medication adherence. Copyright © 2015 Elsevier B.V. All rights reserved.
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Jegatheeswaran, Santhalingam; Siriwardena, Ajith K
2011-01-01
Background Hepatic ischaemia–reperfusion (I/R) injury occurs in both liver resectional surgery and in transplantation. The biochemistry of I/R injury involves short-lived oxygen free radicals. N-acetylcysteine (NAC) is a thiol-containing synthetic compound used in the treatment of acetaminophen toxicity. The present study is a detailed overview of the experimental and clinical evidence for the use of NAC as a pharmaco-protection agent in patients undergoing major liver surgery or transplantation. Methods A computerized search of the Medline, Embase and SCI databases for the period from 1st January 1988 to 31st December 2008 produced 40 reports. For clinical studies, the quality of reports was assessed according to the criteria reported by the Cochrane communication review group. Results Nineteen studies evaluated NAC in experimental liver I/R injury. NAC was administered before induction of ischaemia in 13. The most widely used concentration was 150 mg/kg by intravenous bolus. Fifteen studies report an improvement in outcome, predominantly a reduction in transaminase. Seven studies used an isolated perfused liver model with all showing improvement (predominantly an improvement in bile production after N-acetylcysteine). Two out of four transplantation models showed an improvement in hepatic function. Clinical studies in transplantation show a modest improvement in transaminase levels with no beneficial effect on either patient or graft survival. Conclusion N-acetylcysteine, given before induction of a liver I/R injury in an experimental model can ameliorate liver injury. Clinical outcome data are limited and there is currently little evidence to justify use either in liver transplantation or in liver resectional surgery. PMID:21241423
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Dwan, Kerry; Altman, Douglas G.; Clarke, Mike; Gamble, Carrol; Higgins, Julian P. T.; Sterne, Jonathan A. C.; Williamson, Paula R.; Kirkham, Jamie J.
2014-01-01
Background Most publications about selective reporting in clinical trials have focussed on outcomes. However, selective reporting of analyses for a given outcome may also affect the validity of findings. If analyses are selected on the basis of the results, reporting bias may occur. The aims of this study were to review and summarise the evidence from empirical cohort studies that assessed discrepant or selective reporting of analyses in randomised controlled trials (RCTs). Methods and Findings A systematic review was conducted and included cohort studies that assessed any aspect of the reporting of analyses of RCTs by comparing different trial documents, e.g., protocol compared to trial report, or different sections within a trial publication. The Cochrane Methodology Register, Medline (Ovid), PsycInfo (Ovid), and PubMed were searched on 5 February 2014. Two authors independently selected studies, performed data extraction, and assessed the methodological quality of the eligible studies. Twenty-two studies (containing 3,140 RCTs) published between 2000 and 2013 were included. Twenty-two studies reported on discrepancies between information given in different sources. Discrepancies were found in statistical analyses (eight studies), composite outcomes (one study), the handling of missing data (three studies), unadjusted versus adjusted analyses (three studies), handling of continuous data (three studies), and subgroup analyses (12 studies). Discrepancy rates varied, ranging from 7% (3/42) to 88% (7/8) in statistical analyses, 46% (36/79) to 82% (23/28) in adjusted versus unadjusted analyses, and 61% (11/18) to 100% (25/25) in subgroup analyses. This review is limited in that none of the included studies investigated the evidence for bias resulting from selective reporting of analyses. It was not possible to combine studies to provide overall summary estimates, and so the results of studies are discussed narratively. Conclusions Discrepancies in analyses between publications and other study documentation were common, but reasons for these discrepancies were not discussed in the trial reports. To ensure transparency, protocols and statistical analysis plans need to be published, and investigators should adhere to these or explain discrepancies. Please see later in the article for the Editors' Summary PMID:24959719
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Wang, Michael T M; Bolland, Mark J; Gamble, Greg; Grey, Andrew
2015-01-01
Publication of clinical research findings in prominent journals influences health beliefs and medical practice, in part by engendering news coverage. Randomized controlled trials (RCTs) should be most influential in guiding clinical practice. We determined whether study design of clinical research published in high-impact journals influences media coverage. We compared the incidence and amount of media coverage of RCTs with that of observational studies published in the top 7 medical journals between 1 January 2013 and 31 March 2013. We specifically assessed media coverage of the most rigorous RCTs, those with >1000 participants that reported 'hard' outcomes. There was no difference between RCTs and observational studies in coverage by major newspapers or news agencies, or in total number of news stories generated (all P>0.63). Large RCTs reporting 'hard' outcomes did not generate more news coverage than small RCTs that reported surrogate outcomes and observational studies (all P>0.32). RCTs were more likely than observational studies to attract a journal editorial (70% vs 46%, P = 0.003), but less likely to be the subject of a journal press release (17% vs 50%, P<0.001). Large RCTs that reported 'hard' outcomes did not attract an editorial more frequently than other studies (61% vs 58%, P>0.99), nor were they more likely to be the subject of a journal press release (14% vs 38%, P = 0.14). The design of clinical studies whose results are published in high-impact medical journals is not associated with the likelihood or amount of ensuing news coverage.
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Ford, James H.; Oliver, Karen A.; Giles, Miriam; Cates-Wessel, Kathryn; Krahn, Dean; Levin, Frances R.
2017-01-01
Background and Objectives In 2000, the American Board of Medical Specialties implemented the Maintenance of Certification (MOC), a structured process to help physicians identify and implement a quality improvement project to improve patient care. This study reports on findings from an MOC Performance in Practice (PIP) module designed and evaluated by addiction psychiatrists who are members of the American Academy of Addiction Psychiatry (AAAP). Method A 3-phase process was utilized to recruit AAAP members to participate in the study. The current study utilized data from 154 self-selected AAAP members who evaluated the effectiveness of the MOC Tobacco Cessation PIP. Results Of the physicians participating, 76% (n 120) completed the Tobacco PIP. A paired t-test analysis revealed that reported changes in clinical measure documentation were significant across all six measures. Targeted improvement efforts focused on a single clinical measure. Results found that simple change projects designed to improve clinical practice led to substantial changes in self-reported chart documentation for the selected measure. Conclusions The current findings suggest that addiction psychiatrists can leverage the MOC process to improve clinical care. PMID:27973746
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Scoliosis and dental occlusion: a review of the literature
2011-01-01
Background Idiopathic scoliosis is a deformity without clear etiology. It is unclear wether there is an association between malocclusion and scoliosis. Several types of occlusion were described in subjects with scoliosis, mostly case-reports. Objectives The aim of this review was to evaluate the type of occluslins more prevalent in subjects with scoliosis Search strategy All randomised and controlled clinical trials identified from the Cochrane Oral Health Group Trials Register, a MEDLINE search using the Mesh term scoliosis, malocclusion, and relevant free text words, and the bibliographies of papers and review articles which reported the outcome of orthodontic treatment in subjects with scoliosis that were published as abstracts or papers between 1970 and 2010. Selection criteria All randomised and controlled clinical trials published as full papers or abstracts which reported quantitative data on the outcomes malocclusion in subjects with scoliosis. Data collection and analysis Data were extracted without blinding to the authors, age of patients or type of occlusion. Main results Using the search strategy eleven observational longitudinal studies were identified. No randomized clinical trials were recorded. Twenty-three cross-sectional studies were recorderd, and the others studies were reviews, editorials, case-reports, or opinions. The clinical trials were often not controlled and were about the cephalometric evaluation after treatment with the modified Milwuakee brace, followed by the orthodontic treatment of the class II relationship with a functional appliance. Clinical trials also included the study of the associations between scoliosis and unilateral crossbite, in children with asymmetry of the upper cervical spine. This association was also investigated in rats, pigs and rabbits in clinical trials. The other associations between scoliosis and occlusion seems to be based only on cross-sectional studies, case-reports, opinions. Authors' conclusions Based on selected studies, this review concludes that there is plausible evidence for an increased prevalence of unilateral Angle Class II malocclusions associated with scoliosis, and an increased risk of lateral crossbite, midline deviation in children affected by scoliosis. Also, documentation of associations between reduced range of lateral movements and scoliosis seem convincing. Data are also mentioned about the association between plagiocephaly and scoliosis. PMID:21801357
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Östhols, Sara; Boström, Carina; Rasmussen-Barr, Eva
2018-05-09
We aimed to map the physiotherapy practice in Sweden of clinical tests and patient-reported outcome measures in low-back pain (LBP), and to study advantages and barriers in using patient-reported outcome measures. An online survey was mailed to 4934 physiotherapists in primary health care in Sweden. Multiple choice questions investigated the use of clinical tests and patient-reported outcome measures in assessing patients with LBP. Open questions investigating the advantages and barriers to the use of patient-reported outcome measures were analyzed with content analysis. The response rate was 25% (n = 1217). Clinical tests were used "always/often" by >60% of the participants, while most patient-reported outcome measures were used by <15%. Advantages in using patient-reported outcome measures were: the clinical reasoning process, to increase the quality of assessment, to get the patient's voice, education and motivation of patients, and communication with health professionals. Barriers were lack of time and knowledge, administrative aspects, the interaction between physiotherapist and patient and, the applicability and validity of the patient-reported outcome measures. Our findings show that physiotherapists working in primary health care use clinical testing in LBP to a great extent, while various patient-reported outcome measures are used to a low-to-very-low extent. Several barriers to the use of patient-reported outcome measures were reported such as time, knowledge, and administrative issues, while important findings on advantages were to enhance the clinical reasoning process and to educate and motivate the patient. Barriers might be changed through education or organizational change-work. To enhance the use of patient-reported outcome measures and thus person-centered care in low-back pain, recommendation, and education on various patient-reported outcome measures need to be advocated. Implications for rehabilitation To increase the effects of rehabilitation in low-back pain, yellow flags, and other factors need to be taken into the consideration in the assessment which means the use of patient-reported outcome measures in addition to clinical testing. The use of patient-reported outcome measures is an advantage in the clinical reasoning process to enhance the quality of assessment and to educate and motivate the patient. Barriers to use patient-reported outcome measures are mainly lack of time and knowledge, and administrative aspects. Through education or organizational change-work, barriers to the use of patient-reported outcome measures might be changed.
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Cairo, Francesco; Sanz, Ignacio; Matesanz, Paula; Nieri, Michele; Pagliaro, Umberto
2012-02-01
The aim of this systematic review (SR) was to assess the quality of reporting randomized clinical trials (RCTs) in the field of implant dentistry, its evolution over time and the possible relations between quality items and reported outcomes. RCTs in implant dentistry were retrieved through electronic and hand searches. Risk of bias in individual studies was assessed focusing on study design, outcome assessment and clinical relevance. Associations between quality items and year of publication of RCTs or reporting of statistically significant outcomes were tested. Among the 495 originally screened manuscripts published from 1989 to April 2011, 276 RCTs were assessed in this SR; 59% of them were published between 2006 and 2011. RCTs were mainly parallel (65%), with a single centre (83%) and a superiority design (88%). Trials in implant dentistry showed several methodological flaws: only 37% showed a random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, only 12% performed a correct sample size calculation, the examiner was blind solely in 42% of studies where blinding was feasible. In addition, only 21% of RCTs declared operator experience and 31% reported patient-related outcomes. Many quality items improved over time. Allocation concealment at high risk of bias (p = 0.0125), no information on drop-out (p = 0.0318) and lack of CONSORT adherence (p = 0.0333) were associated with statistically significant reported outcomes. The overall quality of reporting of RCTs in implant dentistry is poor and only partially improved in the last years. Caution is suggested when interpreting these RCTs since risk of bias was associated with higher chance of reporting of statistically significant results. © 2012 John Wiley & Sons A/S.
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Characteristics and publication patterns of obstetric studies registered in ClinicalTrials.gov.
Stockmann, Chris; Sherwin, Catherine M T; Koren, Gideon; Campbell, Sarah C; Constance, Jonathan E; Linakis, Matthew; Balch, Alfred; Varner, Michael W; Spigarelli, Michael G
2014-04-01
Physiologic changes during pregnancy alter the pharmacokinetics, safety, and efficacy of many drugs. For clinicians, there is often uncertainty regarding the safety of these drugs due to a scarcity of published data. This study aimed to comprehensively evaluate the characteristics and publication patterns of obstetric studies registered in ClinicalTrials.gov from 2007 to 2012. Primary outcome measures, funding sources, inclusion criteria, and the reporting of study results were evaluated. A manual review of Medline/PubMed was performed to identify publications associated with studies registered in ClinicalTrials.gov. Of 93,709 total studies, there were 5,203 (6%) obstetric studies registered in ClinicalTrials.gov. Interventional studies accounted for 70% and 30% were observational. Clinical trials of drugs (49%), procedures (13%), and behavioral interventions (12%) were most common. Among interventional drug trials, 84% featured randomized allocation to study arms and 93% included measures of safety and/or efficacy as primary endpoints. Of 946 (18%) studies completed more than 2 years ago, only 11% had reported results and <7% had been published. In an area with a great need for evidence of safe and effective therapies, the low publication rate of completed studies incorporating elements of high-quality trial design is concerning. The sources of this trend should be closely investigated. © 2013, The American College of Clinical Pharmacology.
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Manifesto: towards a clinically-oriented psychometrics.
Vickers, Andrew J; Chen, Ling Y
2017-04-26
New technologies to collect patient - reported outcomes have substantially solved the challenge of integrating a questionnaire in a busy clinical practice. At Memorial Sloan Kettering, we have been collecting patient reported outcomes electronically for many years. Our experience confirms the predicted benefits of obtaining patient reported outcomes but has also raised serious concerns about whether instruments developed for the research setting are appropriate for routine clinical use. We summarize four principles for a clinically - relevant psychometrics. First, minimize patient burden: the use of a large number of items for a single domain may be of interest for research but additional items have little clinical utility. Secondly, use simplified language: patients who do not have good language skills are typically excluded from research studies but will nonetheless present in clinical practice. Third, avoid dumb questions: many questionnaire items are inappropriate when applied to a more general population. Fourth, what works for the group may not work for the individual: group level statistics used to validate survey instruments can obscure problems when applied to a subgroup of patients. There is a need for a clinically-oriented psychometrics to help design, test, and evaluate questionnaires that would be used in routine practice. Developing statistical methods to optimize questionnaires will be highly challenging but needed to bring the potential of patient reported outcomes into widespread clinical use.
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Bo, Ryosuke; Yamada, Kenji; Kobayashi, Hironori; Jamiyan, Purevsuren; Hasegawa, Yuki; Taketani, Takeshi; Fukuda, Seiji; Hata, Ikue; Niida, Yo; Shigematsu, Yosuke; Iijima, Kazumoto; Yamaguchi, Seiji
2017-09-01
Mitochondrial trifunctional protein (TFP) deficiency is an inherited metabolic disorder of mitochondrial fatty-acid oxidation. Isolated long-chain 3-hydroxyacyl-CoA dehydrogenase deficiency is often reported in Caucasian countries due to a common mutation. However, the molecular and clinical basis of complete TFP deficiency has not been extensively reported. In this study, 14 Japanese cases (13 families) with complete TFP deficiency, including 9 previously reported cases, were analyzed to clarify the clinical and molecular characteristics of TFP deficiency. The clinical types of the 14 patients were as follows: 12 cases of neonatal (n=7) or myopathic (n=5) types and 2 cases of intermediate type. Peripheral neuropathy was found in four cases and hypocalcemia due to hypoparathyroidism, which is rarely reported in Caucasian patients, had developed in four cases. Maternal hemolysis, elevated liver enzymes and low platelet count syndrome and acute fatty liver of pregnancy were noted in two and one mothers, respectively. Fourteen mutations were identified in 26 alleles in Japanese patients, including two novel mutations (HADHA: c.361C>T, and HADHA-HADHB: g.26233880_ 26248855del), although no common mutations were found. This study suggests that the molecular and clinical aspects of Japanese patients with TFP deficiencies differ from those of Caucasian patients.
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Reiber, Gayle E; Au, David; McDonell, Mary; Fihn, Stephan D
2004-05-01
To conduct a group-randomized clinical trial to determine whether regular feedback to primary care providers of synthesized information on patients' health, function, and satisfaction would demonstrate improved outcomes for their patients with diabetes. Patients in General Internal Medicine Clinics Department of Veterans Affairs (VA) Medical Centers were randomized into seven intervention or control firms. Patient self-reported information was collected by mail on general health, diabetes, and up to five other chronic conditions. Patients with diabetes received the Seattle Diabetes Questionnaire, the 36-item Medical Outcomes Study short form (SF-36), and a validated patient satisfaction questionnaire at regular intervals. Data from self-report, clinical, pharmacy, and laboratory sources were synthesized into patient-specific feedback reports that intervention providers received before patients' visits. The timely delivery to primary care providers of state-of-the-art patient-feedback reports that identified patient issues and areas for improvement did not result in significant improvements in patient outcomes between the intervention and control firms. Outcomes in diabetic patients whose providers received synthesized patient data before visits were no better than in those receiving care from control firms. Future studies may benefit from substantial involvement in patients discussing, problem solving, and goal setting in addition to use of timely synthesized patient data.
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Navrady, L B; Adams, M J; Chan, S W Y; Ritchie, S J; McIntosh, A M
2017-11-29
Polygenic risk scores (PRS) for depression correlate with depression status and chronicity, and provide causal anchors to identify depressive mechanisms. Neuroticism is phenotypically and genetically positively associated with depression, whereas psychological resilience demonstrates negative phenotypic associations. Whether increased neuroticism and reduced resilience are downstream mediators of genetic risk for depression, and whether they contribute independently to risk remains unknown. Moderating and mediating relationships between depression PRS, neuroticism, resilience and both clinical and self-reported depression were examined in a large, population-based cohort, Generation Scotland: Scottish Family Health Study (N = 4166), using linear regression and structural equation modelling. Neuroticism and resilience were measured by the Eysenck Personality Scale Short Form Revised and the Brief Resilience Scale, respectively. PRS for depression was associated with increased likelihood of self-reported and clinical depression. No interaction was found between PRS and neuroticism, or between PRS and resilience. Neuroticism was associated with increased likelihood of self-reported and clinical depression, whereas resilience was associated with reduced risk. Structural equation modelling suggested the association between PRS and self-reported and clinical depression was mediated by neuroticism (43-57%), while resilience mediated the association in the opposite direction (37-40%). For both self-reported and clinical diagnoses, the genetic risk for depression was independently mediated by neuroticism and resilience. Findings suggest polygenic risk for depression increases vulnerability for self-reported and clinical depression through independent effects on increased neuroticism and reduced psychological resilience. In addition, two partially independent mechanisms - neuroticism and resilience - may form part of the pathway of vulnerability to depression.
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The reporting of clinical signs in laboratory animals: FELASA Working Group Report.
Fentener van Vlissingen, J M; Borrens, M; Girod, A; Lelovas, P; Morrison, F; Torres, Y Saavedra
2015-10-01
Observing and reporting clinical signs in laboratory animals is necessary for many reasons: the assessment of animal welfare, compliance with the principle of refinement (e.g. humane endpoints), regulatory compliance (e.g. reporting severity) and, importantly, as a scientific outcome, e.g. in animal models of disease or safety studies. Developments in the reporting of clinical signs will enhance the scientific value gained from animal experiments and further address the ethical cost. This paper discusses systematic approaches to the observation and reporting of clinical signs in animals (to be) used for research. Glossaries from public and corporate institutions have been consulted and a reference glossary has been set up, providing terminology to be tailored for institutional or project-specific use. The clinical examination of animals must be carried out by competent and specifically trained staff in a systematic way and repeated at adequate intervals and clinical observations must be registered effectively to allow this information to be used. The development of institutional or project-specific glossaries and the use of handwritten records or automated databases are discussed in detail. Among the users are animal care staff, veterinarians and researchers who will need to agree on a given set of clinical signs to be monitored routinely or as a scientific read-out and to train for the proper application. The paper introduces a long list of clinical signs with scientific terminology, descriptions and explanations as a reference glossary to be published and maintained online as a living document supported by the authors as an editorial committee. © The Author(s) 2015.
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Clinical significance of heterotopic gastric mucosal patch of the proximal esophagus
Chong, Vui Heng
2013-01-01
Heterotopic gastric mucosa of the proximal esophagus (HGMPE), also referred to as “inlet patch” or “cervical inlet patch”, is a salmon colored patch that is usually located just distal to the upper esophageal sphincter. HGMPE is uncommon with endoscopic studies reporting a prevalence ranging from less than one percent to 18%. Most HGMPE are asymptomatic and are detected incidentally during endoscopy for evaluations of other gastrointestinal complaints. Most consider HGMPE as clinically irrelevant entity. The clinical significance of HGMPE is mainly acid related or neoplastic transformation. The reported prevalence of laryngopharyngeal reflux symptoms varies from less than 20% to as high as 73.1%. However, most of these symptoms are mild. Clinically significant acid related complications such as bleeding, ulcerations, structure and fistulization have been reported. Although rare, dysplastic changes and malignancies in association with HGMPE have also been reported. Associations with Barrett’s esophagus have also been reported but the findings so far have been conflicting. There are still many areas that are unknown or not well understood and these include the natural history of HGMPE, risk factors for complications, role of Helicobacter pylori infection and factors associated with malignant transformations. Follow-up may need to be considered for patients with complications of HGMPE and surveillance if biopsies show intestinal metaplasia or dysplastic changes. Despite the overall low incidence of clinically relevant manifestations reported in the literature, HGMPE is a clinically significant entity but further researches are required to better understand its clinical significance. PMID:23372354
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Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming
2017-01-01
Objectives Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. Setting The setting for this research was a major academic institution in Beijing, China. Participants The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Methods Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Results Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. Conclusion These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive planning procedures such as those used by expert clinical researchers. PMID:28928184
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Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming
2017-09-18
Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. The setting for this research was a major academic institution in Beijing, China. The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive planning procedures such as those used by expert clinical researchers. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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ERIC Educational Resources Information Center
Marshall, Keith; Willoughby-Booth, Simon
2007-01-01
There are few reliable self-report measures suitable for people with a learning disability in reporting psychological distress. This study examines the modification of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), exploring its reliability, using two different presentation styles. One style included a sequencing task then…
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Cross-Gender Mentorship in Clinical Psychology Doctoral Programs: An Exploratory Survey Study
ERIC Educational Resources Information Center
Harden, Sherry L.; Clark, Richard A.; Johnson, W. Brad; Larson, Joshua
2009-01-01
The mentorship experiences of recent clinical psychology doctorates reporting a primary mentor in graduate school were assessed by means of a survey. Among 518 responding psychologists, male graduates were significantly more likely to have a same-gender mentor, and female graduates were more likely to report receiving support from mentors of both…
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Clouten, Norene; Homma, Midori; Shimada, Rie
2006-01-01
Clinical education is an integral part of preparation for the profession of physical therapy and the role of the clinical instructor is critical. The purpose of this study was to investigate clinical instructors' expectations of student physical therapists with different ethnic backgrounds and the clinical performance of the students as assessed using a modification of the Generic Abilities Assessment. For this study, individuals with a Caucasian ethnic background who were raised in the United States were considered as the majority. The remaining individuals (minority) were subdivided into five groups: African American, Hispanic, Asian/Pacific Islander, Caucasian from outside the United States, and Other. Clinical instructors reported their experiences with students from different ethnic backgrounds, their expectation of students' performance, and recollections of specific weaknesses in performance. From the 216 surveys distributed, 192 clinical instructors responded. Fifty-seven percent had supervised a minority student, with a mean of three students each. While 4% reported that they expected a higher standard from majority students, 17% noted a difference in performance between majority and minority students. Results from this study suggest that minority students would benefit from further preparation in communication and interpersonal skills but they are stronger than majority students in stress management and the effective use of time and resources.
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Abortion, Miscarriage, and Breast Cancer Risk
... factor for breast cancer in postmenopausal women. Summary Report: Early Reproductive Events and Breast Cancer Workshop Introduction ... and the biologic mechanisms identified (animal studies). This report summarizes the epidemiologic, clinical and animal studies findings ...
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Hall, Charlotte L; Walker, Gemma M; Valentine, Althea Z; Guo, Boliang; Kaylor-Hughes, Catherine; James, Marilyn; Daley, David; Sayal, Kapil; Hollis, Chris
2014-12-01
The National Institute for Health and Care Excellence (NICE) guidelines for attention deficit/hyperactivity disorder (ADHD) state that young people need to have access to the best evidence-based care to improve outcome. The current 'gold standard' ADHD diagnostic assessment combines clinical observation with subjective parent, teacher and self-reports. In routine practice, reports from multiple informants may be unavailable or contradictory, leading to diagnostic uncertainty and delay. The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes. This trial investigates whether providing clinicians with an objective report of levels of attention, impulsivity and activity can lead to an earlier, and more accurate, clinical diagnosis and improved patient outcome. This multisite randomised controlled trial will recruit young people (aged 6-17 years old) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services (CAMHS) and Community Paediatric clinics across England. Routine clinical assessment will be augmented by the QbTest, incorporating a continuous performance test (CPT) and infrared motion tracking of activity. The participant will be randomised into one of two study arms: QbOpen (clinician has immediate access to a QbTest report): QbBlind (report is withheld until the study end). Primary outcomes are time to diagnosis and diagnostic accuracy. Secondary outcomes include clinician's diagnostic confidence and routine clinical outcome measures. Cost-effective analysis will be conducted, alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice. The findings from the study will inform commissioners, clinicians and managers about the feasibility, acceptability, clinical utility and cost-effectiveness of incorporating QbTest into routine diagnostic assessment of young people with ADHD. The results will be submitted for publication in peer-reviewed journals. The study has received ethical approval. NCT02209116. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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Hall, Charlotte L; Walker, Gemma M; Valentine, Althea Z; Guo, Boliang; Kaylor-Hughes, Catherine; James, Marilyn; Daley, David; Sayal, Kapil; Hollis, Chris
2014-01-01
Introduction The National Institute for Health and Care Excellence (NICE) guidelines for attention deficit/hyperactivity disorder (ADHD) state that young people need to have access to the best evidence-based care to improve outcome. The current ‘gold standard’ ADHD diagnostic assessment combines clinical observation with subjective parent, teacher and self-reports. In routine practice, reports from multiple informants may be unavailable or contradictory, leading to diagnostic uncertainty and delay. The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes. This trial investigates whether providing clinicians with an objective report of levels of attention, impulsivity and activity can lead to an earlier, and more accurate, clinical diagnosis and improved patient outcome. Methods and analysis This multisite randomised controlled trial will recruit young people (aged 6–17 years old) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services (CAMHS) and Community Paediatric clinics across England. Routine clinical assessment will be augmented by the QbTest, incorporating a continuous performance test (CPT) and infrared motion tracking of activity. The participant will be randomised into one of two study arms: QbOpen (clinician has immediate access to a QbTest report): QbBlind (report is withheld until the study end). Primary outcomes are time to diagnosis and diagnostic accuracy. Secondary outcomes include clinician's diagnostic confidence and routine clinical outcome measures. Cost-effective analysis will be conducted, alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice. Ethics and dissemination The findings from the study will inform commissioners, clinicians and managers about the feasibility, acceptability, clinical utility and cost-effectiveness of incorporating QbTest into routine diagnostic assessment of young people with ADHD. The results will be submitted for publication in peer-reviewed journals. The study has received ethical approval. Trial registration number NCT02209116. PMID:25448628
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The Need for Data-Informed Clinical Supervision in Substance Use Disorder Treatment
Ramsey, Alex T.; Baumann, Ana; Silver Wolf, David Patterson; Yan, Yan; Cooper, Ben; Proctor, Enola
2017-01-01
Background Effective clinical supervision is necessary for high-quality care in community-based substance use disorder treatment settings, yet little is known about current supervision practices. Some evidence suggests that supervisors and counselors differ in their experiences of clinical supervision; however, the impact of this misalignment on supervision quality is unclear. Clinical information monitoring systems may support supervision in substance use disorder treatment, but the potential use of these tools must first be explored. Aims First, this study examines the extent to which misaligned supervisor-counselor perceptions impact supervision satisfaction and emphasis on evidence-based treatments. This study also reports on formative work to develop a supervision-based clinical dashboard, an electronic information monitoring system and data visualization tool providing real-time clinical information to engage supervisors and counselors in a coordinated and data-informed manner, help align supervisor-counselor perceptions about supervision, and improve supervision effectiveness. Methods Clinical supervisors and frontline counselors (N=165) from five Midwestern agencies providing substance abuse services completed an online survey using Research Electronic Data Capture (REDCap) software, yielding a 75% response rate. Valid quantitative measures of supervision effectiveness were assessed, along with qualitative perceptions of a supervision-based clinical dashboard. Results Through within-dyad analyses, misalignment between supervisor and counselor perceptions of supervision practices was negatively associated with satisfaction of supervision and reported frequency of discussing several important clinical supervision topics, including evidence-based treatments and client rapport. Participants indicated the most useful clinical dashboard functions and reported important benefits and challenges to using the proposed tool. Discussion Clinical supervision tends to be largely an informal and unstructured process in substance abuse treatment, which may compromise the quality of care. Clinical dashboards may be a well-targeted approach to facilitate data-informed clinical supervision in community-based treatment agencies. PMID:28166480
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The need for data-informed clinical supervision in substance use disorder treatment.
Ramsey, Alex T; Baumann, Ana; Patterson Silver Wolf, David; Yan, Yan; Cooper, Ben; Proctor, Enola
2017-01-01
Effective clinical supervision is necessary for high-quality care in community-based substance use disorder treatment settings, yet little is known about current supervision practices. Some evidence suggests that supervisors and counselors differ in their experiences of clinical supervision; however, the impact of this misalignment on supervision quality is unclear. Clinical information monitoring systems may support supervision in substance use disorder treatment, but the potential use of these tools must first be explored. First, the current study examines the extent to which misaligned supervisor-counselor perceptions impact supervision satisfaction and emphasis on evidence-based treatments. This study also reports on formative work to develop a supervision-based clinical dashboard, an electronic information monitoring system and data visualization tool providing real-time clinical information to engage supervisors and counselors in a coordinated and data-informed manner, help align supervisor-counselor perceptions about supervision, and improve supervision effectiveness. Clinical supervisors and frontline counselors (N = 165) from five Midwestern agencies providing substance abuse services completed an online survey using Research Electronic Data Capture software, yielding a 75% response rate. Valid quantitative measures of supervision effectiveness were administered, along with qualitative perceptions of a supervision-based clinical dashboard. Through within-dyad analyses, misalignment between supervisor and counselor perceptions of supervision practices was negatively associated with satisfaction of supervision and reported frequency of discussing several important clinical supervision topics, including evidence-based treatments and client rapport. Participants indicated the most useful clinical dashboard functions and reported important benefits and challenges to using the proposed tool. Clinical supervision tends to be largely an informal and unstructured process in substance abuse treatment, which may compromise the quality of care. Clinical dashboards may be a well-targeted approach to facilitate data-informed clinical supervision in community-based treatment agencies.
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Morphine Maintenance: The Shreveport Clinic 1919-1923. Special Studies No. 1.
ERIC Educational Resources Information Center
Waldorf, Dan; And Others
This report describes the opiate maintenance clinic established in Shreveport, Louisiana (1919-1923), whose short existence has recently been questioned by researchers. The authors of this manuscript visited with the original director of the clinic and were given permission to use the medical records of patients of the old clinic and numerous…
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Potential drawbacks in cell-assisted lipotransfer: A systematic review of existing reports (Review)
HUANG, SHENG; ZHAO, WEILIANG; WANG, ZIHUA; TAO, KAI; LIU, XIAOYAN; CHANG, PENG
2016-01-01
Cell-assisted lipotransfer (CAL) has been widely used in various clinical applications, including breast augmentation following mammectomy, soft-tissue reconstruction and wound healing. However, the clinical application of CAL has been restricted due to the transplanted fat tissues being readily liquefied and absorbed. The present review examines 57 previously published studies involving CAL, including fat grafting or fat transfer with human adipose-stem cells in all known databases. Of these 57 articles, seven reported the clinical application of CAL. In the 57 studies, the majority of the fat tissues were obtained from the abdomen via liposuction of the seven clinical studies, four were performed in patients requiring breast augmentation, one in a patient requiring facial augmentation, one in a patient requiring soft tissue augmentation/reconstruction and one in a patient requiring fat in their upper arms. Despite the potential risks, there has been an increased demand for CAL in in cosmetic or aesthetic applications. Thus, criteria and guidelines are necessary for the clinical application of CAL technology. PMID:26677061
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Nurses' Use of Race in Clinical Decision Making.
Sellers, Sherrill L; Moss, Melissa E; Calzone, Kathleen; Abdallah, Khadijah E; Jenkins, Jean F; Bonham, Vence L
2016-11-01
To examine nurses' self-reported use of race in clinical evaluation. This cross-sectional study analyzed data collected from three separate studies using the Genetics and Genomics in Nursing Practice Survey, which includes items about use of race and genomic information in nursing practice. The Racial Attributes in Clinical Evaluation (RACE) scale was used to measure explicit clinical use of race among nurses from across the United States. Multivariate regression analysis was used to examine associations between RACE score and individual-level characteristics and beliefs in 5,733 registered nurses. Analysis revealed significant relationships between RACE score and nurses' race and ethnicity, educational level, and views on the clinical importance of patient demographic characteristics. Asian nurses reported RACE scores 1.41 points higher than White nurses (p < .001), and Black nurses reported RACE scores 0.55 points higher than White nurses (p < .05). Compared to diploma-level nurses, the baccalaureate-level nurses reported 0.69 points higher RACE scores (p < .05), master's-level nurses reported 1.63 points higher RACE scores (p < .001), and doctorate-level nurses reported 1.77 points higher RACE scores (p < .01). In terms of clinical importance of patient characteristics, patient race and ethnicity corresponded to a 0.54-point increase in RACE score (p < .001), patient genes to a 0.21-point increase in RACE score (p < .001), patient family history to a 0.15-point increase in RACE score (p < .01), and patient age to a 0.19-point increase in RACE score (p < .001). Higher reported use of race among minority nurses may be due, in part, to differential levels of racial self-awareness. A relatively linear positive relationship between level of nursing degree nursing education and use of race suggests that a stronger foundation of knowledge about genetic ancestry, population genetics and the concept "race" and genetic ancestry may increase in clinical decision making could allow nurses to more appropriately use of race in clinical care. Integrating patient demographic characteristics into clinical decisions is an important component of nursing practice. Registered nurses provide care for diverse racial and ethnic patient populations and stand on the front line of clinical care, making them essential for reducing racial and ethnic disparities in healthcare delivery. Exploring registered nurses' individual-level characteristics and clinical use of race may provide a more comprehensive understanding of specific training needs and inform nursing education and practice. © 2016 Sigma Theta Tau International.
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Perception Matters for Clinical Perfectionism and Social Anxiety
Levinson, Cheri A.; Rodebaugh, Thomas L.; Shumaker, Erik A.; Menatti, Andrew R.; Weeks, Justin W.; White, Emily K.; Heimberg, Richard G.; Warren, Cortney S.; Blanco, Carlos; Schneier, Franklin; Liebowitz, Michael R.
2014-01-01
Despite research documenting a relationship between social anxiety and perfectionism, very little research has examined the relationship between social anxiety and clinical perfectionism, defined as the combination of high personal standards and high maladaptive perfectionistic evaluative concern. In the current studies we examined whether clinical perfectionism predicted social anxiety in a large sample of undergraduates (N = 602), in a clinical sample of participants diagnosed with social anxiety disorder (SAD; N = 180), and by using a variance decomposition model of self-and informant-report of perfectionism (N = 134). Using self-report, we found that an interaction of personal standards and evaluative concern predicted both social interaction anxiety and fear of scrutiny, but not in the theorized direction. Specifically, we found that self-report of low standards and high evaluative concern was associated with the highest levels of social anxiety, suggesting that when individuals with SAD hold low expectations for themselves combined with high concerns about evaluation, social anxiety symptoms may increase. Alternatively, when an informants’ perspective was considered, and more consistent with the original theory, we found that the interaction of informant-only report of personal standards and shared-report (between both primary participant and informant) of concern over mistakes was associated with self-reported social anxiety, such that high concern over mistakes and high personal standards predicted the highest levels of social anxiety. Theoretical, clinical, and measurement implications for clinical perfectionism are discussed. PMID:25486087
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Saps, M; Lavigne, J V
2015-06-01
The Food and Drug Administration (FDA) recommended ≥30% decrease on patient-reported outcomes for pain be considered clinically significant in clinical trials for adults with irritable bowel syndrome. This percent change approach may not be appropriate for children. We compared three alternate approaches to determining clinically significant reductions in pain among children. 80 children with functional abdominal pain participated in a study of the efficacy of amitriptyline. Endpoints included patient-reported estimates of feeling better, and pain Visual Analog Scale (VAS). The minimum clinically important difference in pain report was calculated as (i) mean change in VAS score for children reporting being 'better'; (ii) percent changes in pain (≥30% and ≥50%) on the VAS; and (iii) statistically reliable changes on the VAS for 68% and 95% confidence intervals. There was poor agreement between the three approaches. 43.6% of the children who met the FDA ≥30% criterion for clinically significant change did not achieve a reliable level of improvement (95% confidence interval). Children's self-reported ratings of being better may not be statistically reliable. A combined approach in which children must report improvement as better and achieve a statistically significant change may be more appropriate for outcomes in clinical trials. © 2015 John Wiley & Sons Ltd.
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Cavitary Pulmonary Sporotrichosis: Case Report and Literature Review.
Rojas, Florencia D; Fernández, Mariana S; Lucchelli, Juan Manuel; Lombardi, Dora; Malet, José; Vetrisano, María Eugenia; Cattana, María Emilia; Sosa, María de Los Ángeles; Giusiano, Gustavo
2017-12-01
A case of cavitary pulmonary sporotrichosis without mucocutaneous involvement caused by Sporothrix schenckii is reported in a sexagenarian woman with a long smoking history. The patient was hospitalized for septic shock with multiorgan failure from a respiratory focus. The diagnosis was delayed due to the fungal etiological agent was not initially considered in the differential diagnosis. A good clinical and radiological evolution was obtained with the antifungal therapy. Occasional cases of primary pulmonary sporotrichosis have been reported in the literature. Due to its low incidence, this is a less-known and underestimated clinical form. Both clinical suspicion and microbiological studies are needed to reach pulmonary sporotrichosis diagnosis.
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Reporting of sample size calculations in analgesic clinical trials: ACTTION systematic review.
McKeown, Andrew; Gewandter, Jennifer S; McDermott, Michael P; Pawlowski, Joseph R; Poli, Joseph J; Rothstein, Daniel; Farrar, John T; Gilron, Ian; Katz, Nathaniel P; Lin, Allison H; Rappaport, Bob A; Rowbotham, Michael C; Turk, Dennis C; Dworkin, Robert H; Smith, Shannon M
2015-03-01
Sample size calculations determine the number of participants required to have sufficiently high power to detect a given treatment effect. In this review, we examined the reporting quality of sample size calculations in 172 publications of double-blind randomized controlled trials of noninvasive pharmacologic or interventional (ie, invasive) pain treatments published in European Journal of Pain, Journal of Pain, and Pain from January 2006 through June 2013. Sixty-five percent of publications reported a sample size calculation but only 38% provided all elements required to replicate the calculated sample size. In publications reporting at least 1 element, 54% provided a justification for the treatment effect used to calculate sample size, and 24% of studies with continuous outcome variables justified the variability estimate. Publications of clinical pain condition trials reported a sample size calculation more frequently than experimental pain model trials (77% vs 33%, P < .001) but did not differ in the frequency of reporting all required elements. No significant differences in reporting of any or all elements were detected between publications of trials with industry and nonindustry sponsorship. Twenty-eight percent included a discrepancy between the reported number of planned and randomized participants. This study suggests that sample size calculation reporting in analgesic trial publications is usually incomplete. Investigators should provide detailed accounts of sample size calculations in publications of clinical trials of pain treatments, which is necessary for reporting transparency and communication of pre-trial design decisions. In this systematic review of analgesic clinical trials, sample size calculations and the required elements (eg, treatment effect to be detected; power level) were incompletely reported. A lack of transparency regarding sample size calculations may raise questions about the appropriateness of the calculated sample size. Copyright © 2015 American Pain Society. All rights reserved.
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2010-01-01
Background The Organizational Readiness to Change Assessment (ORCA) is a measure of organizational readiness for implementing practice change in healthcare settings that is organized based on the core elements and sub-elements of the Promoting Action on Research Implementation in Health Services (PARIHS) framework. General support for the reliability and factor structure of the ORCA has been reported. However, no published study has examined the utility of the ORCA in a clinical setting. The purpose of the current study was to examine the relationship between baseline ORCA scores and implementation of hepatitis prevention services in substance use disorders (SUD) clinics. Methods Nine clinic teams from Veterans Health Administration SUD clinics across the United States participated in a six-month training program to promote evidence-based practices for hepatitis prevention. A representative from each team completed the ORCA evidence and context subscales at baseline. Results Eight of nine clinics reported implementation of at least one new hepatitis prevention practice after completing the six-month training program. Clinic teams were categorized by level of implementation-high (n = 4) versus low (n = 5)-based on how many hepatitis prevention practices were integrated into their clinics after completing the training program. High implementation teams had significantly higher scores on the patient experience and leadership culture subscales of the ORCA compared to low implementation teams. While not reaching significance in this small sample, high implementation clinics also had higher scores on the research, clinical experience, staff culture, leadership behavior, and measurement subscales as compared to low implementation clinics. Conclusions The results of this study suggest that the ORCA was able to measure differences in organizational factors at baseline between clinics that reported high and low implementation of practice recommendations at follow-up. This supports the use of the ORCA to describe factors related to implementing practice recommendations in clinical settings. Future research utilizing larger sample sizes will be essential to support these preliminary findings. PMID:20546584
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Alper, Brian S; Fedorowicz, Zbys; van Zuuren, Esther J
2015-08-01
To determine how often clinical conclusions derived from Cochrane Reviews have uncertain validity due to review conduct and reporting deficiencies. We evaluated 5142 clinical conclusions in DynaMed (an evidence-based point-of-care clinical reference) based on 4743 Cochrane Reviews. Clinical conclusions with level 2 evidence due to shortcomings in the review's conduct or reporting (rather than deficiencies in the underlying evidence) were confirmed by a DynaMed editor and two Cochrane Review authors. Thirty-one Cochrane Reviews (0.65%) had confirmed deficiencies in conduct and reporting as the reason for classifying 37 assessed clinical conclusions (0.72%) as level 2 evidence. In all cases, it was not feasible for the assessors to specify a clear criticism of the studies included in the reviews. The deficiencies were specific to not accounting for dropouts (2) or inadequate assessment and reporting of allocation concealment (11), other specific trial quality criteria (14), or all trial quality criteria (4). Cochrane Reviews provide high-quality assessment and synthesis of evidence, with fewer than 1% of Cochrane Reviews having limitations which hinder the summary of best current evidence for clinical decision-making. We expect this will further decrease following recent Cochrane quality initiatives. © 2015 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd.
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Leite, Elton T T; Moraes, Fabio Y; Marta, Gustavo N; Taunk, Neil K; Vieira, Marina T L; Hanna, Samir A; Silva, João Luis F; Carvalho, Heloisa A
2017-06-01
We aim to assess any association between study and self-reported conflict of interest (COI) or trial sponsorship in breast cancer radiation clinical trials. We searched PubMed for all clinical trials (CTs) published between 09/2004 and 09/2014 related to breast cancer. We included only radiotherapy CTs with primary clinical endpoints. We classified eligible trials according to the funding source, presence or absence of conflict of interest, study conclusion and impact factor (IF). 1,603 CTs were retrieved. 72 randomized clinical trials were included for analysis. For-profit (PO), not for profit organization (nPO), none and not reported sponsorship rates were 9/72 (12.5%), 35/72 (48.6%), 1/72 (1.4%), 27/72 (37.5%), respectively. Present, absent or not reported COI were found in 6/72 (8.3%), 43/72 (59.7%) and 23/72 (32%) of the CTs, respectively. Conclusion was positive, neutral and negative in 57/72 (79.1%), 9/72 (12.5%) and 6/72 (8.4%) of the trials, respectively. Positive conclusion was reported in 33/44 (75%) funded trials (PO and nPO) and 5/6 (83.3%) CTs with reported COI. On univariate analysis no association with funding source (P=0.178), COI (P=0.678) or trial region (P=0.567) and trial positive conclusion was found. Sponsored trials (HR 4.50, 95CI-0.1.23-16.53;P=0.0023) and positive trials (HR 4.78, 95CI- 1.16-19.63;P=0.030) were more likely to be published in higher impact factor journals in the multivariate analysis. nPO funding was reported in almost 50% of the evaluated CTs. No significant association between study conclusion and funding source, COI or trial region was identified. Sponsored trials and positive trials were more likely to be published in higher impact factor journals. Copyright © 2017 Elsevier Ltd. All rights reserved.
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Oberbaum, Menachem; Lysy, Joseph; Gropp, Cornelius
2011-08-01
The first clinical experiment is described in the bible: The prophet Daniel is reported being nourished during ten days by seeds and water only, in order to check if his physical state would deteriorate as a result of this minimal nutrition. In the 15th century, French surgeon Ambroise Parí experimented with a mixture of turpentine, egg protein and rose oil to treat combat wounds, which is thought to be the first clinical study to be reported. In the 19th century British scientist James Lind designed the first controlled prospective study with parallel groups, proving that ingesting citrus fruit prevents scurvy. A short time afterwards British scientist John Haygarth was the first to use a placebo drug in a clinical study. Important work on placebo was conducted by the American scientists Austin Flint and later by Henry K. Beecher, who showed that placebo itself has biological properties. The importance of comparative studies was first understood by French psychologist CLaude Bernard. He is considered the founder of the modern scientific method based on observation, analysis of data and examination of hypotheses. Bernard's work was based on the work of fellow Frenchman Pierre Charles Alexandre Louis, who is justly considered a founding father of modern epidemiology, and who was the first to use statistics in clinical experiments. Random distributions in clinical studies were reported even before this time, for instance in the work of the Flemish physician Johannes Baptista van Helmont. Danish Nobel prize winner Johannes Fibiger pioneered the use of selection bias in his work with diphtheria serum.
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Building an automated SOAP classifier for emergency department reports.
Mowery, Danielle; Wiebe, Janyce; Visweswaran, Shyam; Harkema, Henk; Chapman, Wendy W
2012-02-01
Information extraction applications that extract structured event and entity information from unstructured text can leverage knowledge of clinical report structure to improve performance. The Subjective, Objective, Assessment, Plan (SOAP) framework, used to structure progress notes to facilitate problem-specific, clinical decision making by physicians, is one example of a well-known, canonical structure in the medical domain. Although its applicability to structuring data is understood, its contribution to information extraction tasks has not yet been determined. The first step to evaluating the SOAP framework's usefulness for clinical information extraction is to apply the model to clinical narratives and develop an automated SOAP classifier that classifies sentences from clinical reports. In this quantitative study, we applied the SOAP framework to sentences from emergency department reports, and trained and evaluated SOAP classifiers built with various linguistic features. We found the SOAP framework can be applied manually to emergency department reports with high agreement (Cohen's kappa coefficients over 0.70). Using a variety of features, we found classifiers for each SOAP class can be created with moderate to outstanding performance with F(1) scores of 93.9 (subjective), 94.5 (objective), 75.7 (assessment), and 77.0 (plan). We look forward to expanding the framework and applying the SOAP classification to clinical information extraction tasks. Copyright © 2011. Published by Elsevier Inc.
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Tobler, Kyle J; Shoham, Gon; Christianson, Mindy S; Zhao, Yulian; Leong, Milton; Shoham, Zeev
2015-10-01
The aim of this study is to assess how anti-mullerian hormone (AMH) is used worldwide to test ovarian reserve and guide in vitro fertilization (IVF) cycle management. An internet-based survey was sent electronically to registered IVF providers within the IVF-Worldwide.com network. This survey consisted of nine questions which assessed the clinics' use of AMH. The questionnaire was completed online through the IVF-Worldwide.com website, and quality assurance tools were used to verify that only one survey was completed per clinical IVF center. Results are reported as the proportion of IVF cycles represented by a particular answer choice. Survey responses were completed from 796 globally distributed IVF clinics, representing 593,200 IVF cycles worldwide. Sixty percent of the respondent-IVF cycles reported to use AMH as a first line test, and 54 % reported it as the best test for evaluating ovarian reserve. Eighty-nine percent reported that AMH results were extremely relevant or relevant to clinical practice. However in contrast, for predicting live birth rate, 81 % reported age as the best predictor. AMH is currently considered a first line test for evaluating ovarian reserve and is considered relevant to clinical practice by the majority of IVF providers.
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Houston, Lauren; Probst, Yasmine; Martin, Allison
2018-05-18
Data audits within clinical settings are extensively used as a major strategy to identify errors, monitor study operations and ensure high-quality data. However, clinical trial guidelines are non-specific in regards to recommended frequency, timing and nature of data audits. The absence of a well-defined data quality definition and method to measure error undermines the reliability of data quality assessment. This review aimed to assess the variability of source data verification (SDV) auditing methods to monitor data quality in a clinical research setting. The scientific databases MEDLINE, Scopus and Science Direct were searched for English language publications, with no date limits applied. Studies were considered if they included data from a clinical trial or clinical research setting and measured and/or reported data quality using a SDV auditing method. In total 15 publications were included. The nature and extent of SDV audit methods in the articles varied widely, depending upon the complexity of the source document, type of study, variables measured (primary or secondary), data audit proportion (3-100%) and collection frequency (6-24 months). Methods for coding, classifying and calculating error were also inconsistent. Transcription errors and inexperienced personnel were the main source of reported error. Repeated SDV audits using the same dataset demonstrated ∼40% improvement in data accuracy and completeness over time. No description was given in regards to what determines poor data quality in clinical trials. A wide range of SDV auditing methods are reported in the published literature though no uniform SDV auditing method could be determined for "best practice" in clinical trials. Published audit methodology articles are warranted for the development of a standardised SDV auditing method to monitor data quality in clinical research settings. Copyright © 2018. Published by Elsevier Inc.
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Shadrack, Daniel M; Swai, Hulda S; Munissi, Joan J E; Mubofu, Egid B; Nyandoro, Stephen S
2018-06-12
Clinical applications of many small molecules are limited due to poor solubility and lack of controlled release besides lack of other desirable properties. Experimental and computational studies have reported on the therapeutic potential of polyamidoamine (PAMAM) dendrimers as solubility enhancers in pre-clinical and clinical settings. Besides formulation strategies, factors such as pH, PAMAM dendrimer generation, PAMAM dendrimer concentration, nature of the PAMAM core, special ligand and surface modifications of PAMAM dendrimer have an influence on drug solubility and other recommendable pharmacological properties. This review, therefore, compiles the recently reported applications of PAMAM dendrimers in pre-clinical and clinical uses as enhancers of solubility and other desirable properties such as sustained and controlled release, bioavailability, bio-distribution, toxicity reduction or enhancement, and targeted delivery of small molecules with emphasis on cancer treatment.
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Pharmacist-led discharge medication counselling: A scoping review.
Bonetti, Aline F; Reis, Wálleri C; Lombardi, Natália Fracaro; Mendes, Antonio M; Netto, Harli Pasquini; Rotta, Inajara; Fernandez-Llimos, Fernando; Pontarolo, Roberto
2018-06-01
Discharge medication counselling has produced improved quality of care and health outcomes, especially by reducing medication errors and readmission rates, and improving medication adherence. However, no studies have assembled an evidence-based discharge counselling process for clinical pharmacists. Thus, the present study aims to map the components of the pharmacist-led discharge medication counselling process. We performed a scoping review by searching electronic databases (Pubmed, Scopus, and DOAJ) and conducting a manual search to identify studies published up to July 2017. Studies that addressed pharmacist-led discharge medication counselling, regardless of the population, clinical conditions, and outcomes evaluated, were included. A total of 1563 studies were retrieved, with 75 matching the inclusion criteria. Thirty-two different components were identified, and the most prevalent were the indication of the medications and adverse drug reactions, which were reported in more than 50% of the studies. The components were reported similarly by studies from the USA and the rest of the world, and over the years. However, 2 differences were identified: the use of a dosage schedule, which was more frequent in studies published in 2011 or before and in studies outside the USA; and the teach-back technique, which was used more frequently in the USA. Poor quality reporting was also observed, especially regarding the duration of the counselling, the number of patients, and the medical condition. Mapping the components of the pharmacist-led discharge counselling studies through a scoping review allowed us to reveal how this service is performed around the world. Wide variability in this process and poor reporting were identified. Future studies are needed to define the core outcome set of this clinical pharmacy service to allow the generation of robust evidence and reproducibility in clinical practice. © 2018 John Wiley & Sons, Ltd.
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Clinical syndrome associated with zolpidem ingestion in dogs: 33 cases (January 1998-July 2000).
Richardson, Jill A; Gwaltney-Brant, Sharon M; Albretsen, Jay C; Khan, Safdar A; Porter, Jessica A
2002-01-01
Zolpidem is a nonbenzodiazepine hypnotic of the imidazopyridine class that is used to treat insomnia in humans. Zolpidem binds selectively to the benzodiazepine omega-1 receptor and increases the frequency of chloride channel opening, which results in inhibition of neuronal excitation. A retrospective study was conducted of zolpidem ingestion in dogs that were reported to the ASPCA Animal Poison Control Center (APCC) between January 1998 and July 2000. Data analysis included amount ingested, clinical effects, and time of onset of signs. Thirty-three reports of zolpidem ingestion in dogs (ranging in age from 5 months to 16 years) were evaluated. Approximate ingested dosages ranged from 0.24 to 21 mg/kg. Clinical signs reported included ataxia (18 dogs; 54.5%), hyperactivity (10 dogs; 30.3%), vomiting (7 dogs; 21.2%), and lethargy (5 dogs; 15.2%), as well as panting, disorientation, nonspecific behavior disorder, and hypersalivation (4 dogs each sign; 12.1%). Other signs reported include tachycardia, tremors, apprehension, vocalization, hypersalivation, weakness, and hyperesthesia. In 85% percent of reports, clinical signs developed within 1 hour and usually resolved within 12 hours. Although central nervous system (CNS) depression is reported as a primary effect of zolpidem in humans and would also be expected in dogs, information obtained from this study indicates that some dogs may exhibit a paradoxical excitation reaction. This effect appears to vary among individual dogs.
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Tafuri, Silvio; Guerra, Rocco; Gallone, Maria Serena; Cappelli, Maria Giovanna; Lanotte, Serafina; Quarto, Michele; Germinario, Cinzia
2014-01-01
This study aims to evaluate the effectiveness of pre-travel counselling carried out in Travel Clinics. This is a retrospective cohort. Three hundred international travellers were enrolled; 150 people were from users of Bari Travel Clinic, 150 were users of a travel agency. Enrolled subjects were interviewed using a questionnaire. The average age of the enrolled subjects was 37.5 ± 13.9, without statistically significant differences between the two groups. 86% of cases and 19.3% of the controls reported the use of anti-malaria prophylaxis (p < 0.0001). Vaccination against cholera was given to 62% of cases and 7.3% of the controls (p < 0.001). Travel Clinic users, 6% reported diarrhoea and these figures were 27% in the control group (p < 0.0001). The proportion of those interviewed who reported fever (3.7) or insomnia (1.3) did not differ between the two groups. Mosquito bites were reported by 8% of cases and 20% of the controls (p = 0.003). Three cases of malaria were reported among the controls but no cases were detected among the cases (chi-square = 3.03; p = 0.08). Our study demonstrated the effectiveness of pre-travel counselling; in the future, new studies must investigate the cost-effectiveness of pre-travel prevention measures.
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Differences between reported and actual restored caries lesion depths: results from The Dental PBRN.
Rindal, D B; Gordan, V V; Fellows, J L; Spurlock, N L; Bauer, M R; Litaker, M S; Gilbert, G H
2014-07-01
The objectives of this research were to: (1) quantify the discordance between the caries lesion depth at which dentists restored initial lesions during a clinical study ("actual depth") and the lesion depth that they reported during a hypothetical clinical scenario ("reported depth"); (2) test the hypothesis that certain practitioner, practice, patient, and caries lesion characteristics are significantly associated with this discordance. Practitioner-investigators who perform restorative dentistry in their practices completed an enrollment questionnaire and participated in 2 consecutive studies on caries diagnosis and treatment. The first study was a survey asking about caries treatment. The second study collected data on restorations placed in routine clinical practice due to caries in patients over 19 years of age on occlusal surfaces only or proximal surfaces only. We report results on 2,691 restorations placed by 205 dentists in 1,930 patients with complete data. Discordance between actual depth and reported depth occurred in only about 2% of the restorations done due to proximal caries, but about 49% of the restorations done due to occlusal caries. Practice type, restorative material used and the diagnostic methods used were significantly associated with discordance. Dentists frequently restored occlusal caries at a shallower depth as compared to their reported depth, but the discordance was very small for proximal lesions. Discordance for occlusal caries was more common when radiographs were not taken or if a resin restoration was placed.
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Clinical Observed Performance Evaluation: A Prospective Study in Final Year Students of Surgery
ERIC Educational Resources Information Center
Markey, G. C.; Browne, K.; Hunter, K.; Hill, A. D.
2011-01-01
We report a prospective study of clinical observed performance evaluation (COPE) for 197 medical students in the pre-qualification year of clinical education. Psychometric quality was the main endpoint. Students were assessed in groups of 5 in 40-min patient encounters, with each student the focus of evaluation for 8 min. Each student had a series…
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Schöpf, V; Kollndorfer, K
2015-07-01
Olfactory dysfunction and loss of smell are mostly associated with an immense decrease in the quality of life. The aim of the presented study was to report on particularities in the acquisition of patients with olfactory dysfunction. During July 2011 and May 2014 we were contacted by 300 potential patients with self-reported loss of smell, 95 (54 female, 41 male, mean age 53) of which were invited for clinical testing after phone interviews. Clinical smell testing revealed 46 patients with anosmia, 38 with hyposmia, and 11 with normosmia. Self-assessment of olfactory function only correlated with clinical scores if patients had nearly no olfactory function left. The ability of self-assessment of olfactory function was independent of age or sex. Further, most patients were not able to report on the reason for or the duration of their olfactory dysfunction. Our report shows that patients with olfactory dysfunction are hardly ever ably to assess their grade of performance reduction. Awareness among patients with a reduced sense of smell is of great general importance, since it can be an indicator of neurodegenerative diseases. This should especially be noted for patients older than 50 who are not able to indicate a reason for their loss of smell.
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Perlmutter, A S; Tran, V-T; Dechartres, A; Ravaud, P
2017-04-01
Protocols are often unavailable to peer-reviewers and readers. To detect outcome reporting bias (ORB), readers usually have to resort to publicly available descriptions of study design such as public clinical trial registries. We compared primary outcomes in protocols, ClinicalTrials.gov and publications of oncology trials and evaluated the use of ClinicalTrials.gov as compared with protocols in detecting discrepancies between planned and published outcomes. We searched for phase III oncology trials registered in ClinicalTrials.gov and published in the Journal of Clinical Oncology and New England Journal of Medicine between January 2014 and June 2015. We extracted primary outcomes reported in the protocol, ClinicalTrials.gov and the publication. First, we assessed the quality of primary outcome descriptions by using a published framework. Second, we evaluated modifications of primary outcomes between each source. Finally, we evaluated the agreement, specificity and sensitivity of detecting modifications between planned and published outcomes by using protocols or ClinicalTrials.gov. We included 65 trials, with 81 primary outcomes common among the 3 sources. The proportion of primary outcomes reporting all items from the framework was 73%, 22%, and 75% for protocols, ClinicalTrials.gov and publications, respectively. Eight (12%) trials presented a discrepancy between primary outcomes reported in the protocol and in the publication. Twelve (18.5%) trials presented a discrepancy between primary outcomes registered at ClinicalTrials.gov and in publications. We found a moderate agreement in detecting discrepant reporting of outcomes by using protocols or ClinicalTrials.gov [κ = 0.53, 95% confidence interval (0.25-0.81)]. Using ClinicalTrials.gov to detect discrepant reporting of outcomes showed high specificity (89.5%) but lacked sensitivity (75%) as compared with use of protocols. In oncology trials, primary outcome descriptions in ClinicalTrials.gov are often of low quality and may not reflect what is in the protocol, thus limiting the detection of modifications between planned and published outcomes. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.
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Safety of probiotics and synbiotics in children under 18 years of age.
van den Nieuwboer, M; Brummer, R J; Guarner, F; Morelli, L; Cabana, M; Claassen, E
2015-01-01
This study aimed to systematically evaluate safety of probiotics and synbiotics in children ageing 0-18 years. This study is the third and final part in a safety trilogy and an update is provided using the most recent available clinical data (2008-2013) by means of the Common Terminology Clinical Adverse Events (CTCAE version 4.0) classification. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. Analysis of 74 clinical studies indicated that probiotic and/or synbiotic administration in children is safe with regard to the specific evaluated strains, dosages and duration. The population of children include healthy, immune compromised and obese subjects, as well as subjects with intestinal disorders, infections and inflammatory disorders. This study revealed no major safety concerns, as the adverse events (AEs) were unrelated, or not suspected to be related, to the probiotic or synbiotic product. In general the study products were well tolerated. Overall, AEs occurred more frequent in the control arm compared to children receiving probiotics and/or synbiotics. Furthermore, the results indicate inadequate reporting and classification of AEs in the majority of the studies. In addition, generalizability of conclusions are greatly limited by the inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes.
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Miller, Elaine R; Moro, Pedro L; Cano, Maria; Lewis, Paige; Bryant-Genevier, Marthe; Shimabukuro, Tom T
2016-05-27
23-Valent pneumococcal polysaccharide vaccine, trade name Pneumovax(®)23 (PPSV23), has been used for decades in the Unites States and has an extensive clinical record. However, limited post-licensure safety assessment has been conducted. To analyze reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following PPSV23 from 1990 to 2013 in order to characterize its safety profile. We searched the VAERS database for US reports following PPSV23 for persons vaccinated from 1990 to 2013. We assessed safety through: automated analysis of VAERS data, crude adverse event (AE) reporting rates based on PPSV23 doses distributed in the US market, clinical review of death reports and reports involving vaccine administered to pregnant women, and empirical Bayesian data mining to assess for disproportional reporting. During the study period, VAERS received 25,168 PPSV23 reports; 92% were non-serious, 67% were in females and 86% were in adults aged ≥19 years. When PPSV23 was administered alone, fever (43%), injection site erythema (28%) and injection site pain (25%) were the most commonly reported non-serious AEs in children. Injection site erythema (32%), injection site pain (27%) and injection site swelling (23%) were the most commonly reported non-serious AEs in adults. Of serious reports (2129, 8% of total), fever was most commonly reported in both children (69%) and adults (39%). There were 66 reports of death, four in children and 62 in adults. Clinical review of death reports did not reveal any concerning patterns that would suggest a causal association with PPSV23. No disproportional reporting of unexpected AEs was observed in empirical Bayesian data mining. We did not identify any new or unexpected safety concerns for PPSV23. The VAERS data are consistent with safety data from pre-licensure clinical trials and other post-licensure studies. Published by Elsevier Ltd.
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Hickey, Graeme L; Blackstone, Eugene H
2016-08-01
Clinical risk-prediction models serve an important role in healthcare. They are used for clinical decision-making and measuring the performance of healthcare providers. To establish confidence in a model, external model validation is imperative. When designing such an external model validation study, thought must be given to patient selection, risk factor and outcome definitions, missing data, and the transparent reporting of the analysis. In addition, there are a number of statistical methods available for external model validation. Execution of a rigorous external validation study rests in proper study design, application of suitable statistical methods, and transparent reporting. Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.
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Quinn, Gillian; Comber, Laura; Galvin, Rose; Coote, Susan
2018-05-01
To determine the ability of clinical measures of balance to distinguish fallers from non-fallers and to determine their predictive validity in identifying those at risk of falls. AMED, CINAHL, Medline, Scopus, PubMed Central and Google Scholar. First search: July 2015. Final search: October 2017. Inclusion criteria were studies of adults with a definite multiple sclerosis diagnosis, a clinical balance assessment and method of falls recording. Data were extracted independently by two reviewers. Study quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 scale and the modified Newcastle-Ottawa Quality Assessment Scale. Statistical analysis was conducted for the cross-sectional studies using Review Manager 5. The mean difference with 95% confidence interval in balance outcomes between fallers and non-fallers was used as the mode of analysis. We included 33 studies (19 cross-sectional, 5 randomised controlled trials, 9 prospective) with a total of 3901 participants, of which 1917 (49%) were classified as fallers. The balance measures most commonly reported were the Berg Balance Scale, Timed Up and Go and Falls Efficacy Scale International. Meta-analysis demonstrated fallers perform significantly worse than non-fallers on all measures analysed except the Timed Up and Go Cognitive ( p < 0.05), but discriminative ability of the measures is commonly not reported. Of those reported, the Activities-specific Balance Confidence Scale had the highest area under the receiver operating characteristic curve value (0.92), but without reporting corresponding measures of clinical utility. Clinical measures of balance differ significantly between fallers and non-fallers but have poor predictive ability for falls risk in people with multiple sclerosis.
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Sayre, Jerry W; Toklu, Hale Z; Ye, Fan; Mazza, Joseph; Yale, Steven
2017-08-07
Case reports and case series or case study research are descriptive studies that are prepared for illustrating novel, unusual, or atypical features identified in patients in medical practice, and they potentially generate new research questions. They are empirical inquiries or investigations of a patient or a group of patients in a natural, real-world clinical setting. Case study research is a method that focuses on the contextual analysis of a number of events or conditions and their relationships. There is disagreement among physicians on the value of case studies in the medical literature, particularly for educators focused on teaching evidence-based medicine (EBM) for student learners in graduate medical education. Despite their limitations, case study research is a beneficial tool and learning experience in graduate medical education and among novice researchers. The preparation and presentation of case studies can help students and graduate medical education programs evaluate and apply the six American College of Graduate Medical Education (ACGME) competencies in the areas of medical knowledge, patient care, practice-based learning, professionalism, systems-based practice, and communication. A goal in graduate medical education should be to assist residents to expand their critical thinking, problem-solving, and decision-making skills. These attributes are required in the teaching and practice of EBM. In this aspect, case studies provide a platform for developing clinical skills and problem-based learning methods. Hence, graduate medical education programs should encourage, assist, and support residents in the publication of clinical case studies; and clinical teachers should encourage graduate students to publish case reports during their graduate medical education.
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Bleich, Sara N.; Sherrod, Cheryl; Chiang, Anne; Boyd, Cynthia; Wolff, Jennifer; DuGoff, Eva; Salzberg, Claudia; Anderson, Keely; Leff, Bruce
2015-01-01
Introduction Finding ways to provide better and less expensive health care for people with multiple chronic conditions or disability is a pressing concern. The purpose of this systematic review was to evaluate different approaches for caring for this high-need and high-cost population. Methods We searched Medline for articles published from May 31, 2008, through June 10, 2014, for relevant studies. Articles were considered eligible for this review if they met the following criteria: included people with multiple chronic conditions (behavioral or mental health) or disabilities (2 or more); addressed 1 or more of clinical outcomes, health care use and spending, or patient satisfaction; and compared results from an intervention group with a comparison group or baseline measurements. We extracted information on program characteristics, participant characteristics, and significant (positive and negative) clinical findings, patient satisfaction, and health care use outcomes. For each outcome, the number of significant and positive results was tabulated. Results Twenty-seven studies were included across 5 models of care. Of the 3 studies reporting patient satisfaction outcomes, 2 reported significant improvements; both were randomized controlled trials (RCTs). Of the 14 studies reporting clinical outcomes, 12 reported improvements (8 were RCTs). Of the 13 studies reporting health care use and spending outcomes, 12 reported significant improvements (2 were RCTs). Two models of care — care and case management and disease management — reported improvements in all 3 outcomes. For care and case management models, most improvements were related to health care use. For the disease management models, most improvements were related to clinical outcomes. Conclusions Care and case management as well as disease management may be promising models of care for people with multiple chronic conditions or disabilities. More research and consistent methods are needed to understand the most appropriate care for these high-need and high-cost patients. PMID:26564013
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Bleich, Sara N; Sherrod, Cheryl; Chiang, Anne; Boyd, Cynthia; Wolff, Jennifer; DuGoff, Eva; Chang, Eva; Salzberg, Claudia; Anderson, Keely; Leff, Bruce; Anderson, Gerard
2015-11-12
Finding ways to provide better and less expensive health care for people with multiple chronic conditions or disability is a pressing concern. The purpose of this systematic review was to evaluate different approaches for caring for this high-need and high-cost population. We searched Medline for articles published from May 31, 2008, through June 10, 2014, for relevant studies. Articles were considered eligible for this review if they met the following criteria: included people with multiple chronic conditions (behavioral or mental health) or disabilities (2 or more); addressed 1 or more of clinical outcomes, health care use and spending, or patient satisfaction; and compared results from an intervention group with a comparison group or baseline measurements. We extracted information on program characteristics, participant characteristics, and significant (positive and negative) clinical findings, patient satisfaction, and health care use outcomes. For each outcome, the number of significant and positive results was tabulated. Twenty-seven studies were included across 5 models of care. Of the 3 studies reporting patient satisfaction outcomes, 2 reported significant improvements; both were randomized controlled trials (RCTs). Of the 14 studies reporting clinical outcomes, 12 reported improvements (8 were RCTs). Of the 13 studies reporting health care use and spending outcomes, 12 reported significant improvements (2 were RCTs). Two models of care - care and case management and disease management - reported improvements in all 3 outcomes. For care and case management models, most improvements were related to health care use. For the disease management models, most improvements were related to clinical outcomes. Care and case management as well as disease management may be promising models of care for people with multiple chronic conditions or disabilities. More research and consistent methods are needed to understand the most appropriate care for these high-need and high-cost patients.
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The Impact of Oral-Systemic Health on Advancing Interprofessional Education Outcomes.
Haber, Judith; Hartnett, Erin; Allen, Kenneth; Crowe, Ruth; Adams, Jennifer; Bella, Abigail; Riles, Thomas; Vasilyeva, Anna
2017-02-01
The aim of this study was to evaluate the effectiveness of an interprofessional education (IPE) clinical simulation and case study experience, using oral-systemic health as the clinical population health example, for nurse practitioner/midwifery, dental, and medical students' self-reported attainment of interprofessional competencies. A pretest-posttest evaluation method was employed, using data from the Interprofessional Collaborative Competency Attainment Scale (ICCAS) completed by two large cohorts of nurse practitioner/midwifery, dental, and medical students at one U.S. university. Data from faculty facilitators were collected to assess their perceptions of the value of exposing students to interprofessional clinical simulation experiences focused on oral-systemic health. The results showed that self-reported interprofessional competencies measured by the ICCAS improved significantly from pre- to posttest for all three student types in 2013 (p<0.001) and 2014 (p<0.001). Faculty facilitators reported that the IPE clinical simulation experiences were valuable and positively influenced interprofessional communication, collaboration, patient communication, and student understanding of patient care roles. These results suggest that the Teaching Oral-Systemic Health Program Interprofessional Oral-Systemic Health Clinical Simulation and Case Study Experience was effective as a standardized, replicable curriculum unit using oral-systemic health as a population health exemplar to teach and assess interprofessional competencies with nurse practitioner/midwifery, dental, and medical students.
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Crisan, Anamaria; McKee, Geoffrey; Munzner, Tamara; Gardy, Jennifer L
2018-01-01
Microbial genome sequencing is now being routinely used in many clinical and public health laboratories. Understanding how to report complex genomic test results to stakeholders who may have varying familiarity with genomics-including clinicians, laboratorians, epidemiologists, and researchers-is critical to the successful and sustainable implementation of this new technology; however, there are no evidence-based guidelines for designing such a report in the pathogen genomics domain. Here, we describe an iterative, human-centered approach to creating a report template for communicating tuberculosis (TB) genomic test results. We used Design Study Methodology-a human centered approach drawn from the information visualization domain-to redesign an existing clinical report. We used expert consults and an online questionnaire to discover various stakeholders' needs around the types of data and tasks related to TB that they encounter in their daily workflow. We also evaluated their perceptions of and familiarity with genomic data, as well as its utility at various clinical decision points. These data shaped the design of multiple prototype reports that were compared against the existing report through a second online survey, with the resulting qualitative and quantitative data informing the final, redesigned, report. We recruited 78 participants, 65 of whom were clinicians, nurses, laboratorians, researchers, and epidemiologists involved in TB diagnosis, treatment, and/or surveillance. Our first survey indicated that participants were largely enthusiastic about genomic data, with the majority agreeing on its utility for certain TB diagnosis and treatment tasks and many reporting some confidence in their ability to interpret this type of data (between 58.8% and 94.1%, depending on the specific data type). When we compared our four prototype reports against the existing design, we found that for the majority (86.7%) of design comparisons, participants preferred the alternative prototype designs over the existing version, and that both clinicians and non-clinicians expressed similar design preferences. Participants showed clearer design preferences when asked to compare individual design elements versus entire reports. Both the quantitative and qualitative data informed the design of a revised report, available online as a LaTeX template. We show how a human-centered design approach integrating quantitative and qualitative feedback can be used to design an alternative report for representing complex microbial genomic data. We suggest experimental and design guidelines to inform future design studies in the bioinformatics and microbial genomics domains, and suggest that this type of mixed-methods study is important to facilitate the successful translation of pathogen genomics in the clinic, not only for clinical reports but also more complex bioinformatics data visualization software.
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Crisan, Anamaria; McKee, Geoffrey; Munzner, Tamara
2018-01-01
Background Microbial genome sequencing is now being routinely used in many clinical and public health laboratories. Understanding how to report complex genomic test results to stakeholders who may have varying familiarity with genomics—including clinicians, laboratorians, epidemiologists, and researchers—is critical to the successful and sustainable implementation of this new technology; however, there are no evidence-based guidelines for designing such a report in the pathogen genomics domain. Here, we describe an iterative, human-centered approach to creating a report template for communicating tuberculosis (TB) genomic test results. Methods We used Design Study Methodology—a human centered approach drawn from the information visualization domain—to redesign an existing clinical report. We used expert consults and an online questionnaire to discover various stakeholders’ needs around the types of data and tasks related to TB that they encounter in their daily workflow. We also evaluated their perceptions of and familiarity with genomic data, as well as its utility at various clinical decision points. These data shaped the design of multiple prototype reports that were compared against the existing report through a second online survey, with the resulting qualitative and quantitative data informing the final, redesigned, report. Results We recruited 78 participants, 65 of whom were clinicians, nurses, laboratorians, researchers, and epidemiologists involved in TB diagnosis, treatment, and/or surveillance. Our first survey indicated that participants were largely enthusiastic about genomic data, with the majority agreeing on its utility for certain TB diagnosis and treatment tasks and many reporting some confidence in their ability to interpret this type of data (between 58.8% and 94.1%, depending on the specific data type). When we compared our four prototype reports against the existing design, we found that for the majority (86.7%) of design comparisons, participants preferred the alternative prototype designs over the existing version, and that both clinicians and non-clinicians expressed similar design preferences. Participants showed clearer design preferences when asked to compare individual design elements versus entire reports. Both the quantitative and qualitative data informed the design of a revised report, available online as a LaTeX template. Conclusions We show how a human-centered design approach integrating quantitative and qualitative feedback can be used to design an alternative report for representing complex microbial genomic data. We suggest experimental and design guidelines to inform future design studies in the bioinformatics and microbial genomics domains, and suggest that this type of mixed-methods study is important to facilitate the successful translation of pathogen genomics in the clinic, not only for clinical reports but also more complex bioinformatics data visualization software. PMID:29340235
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Singer, R B
2000-01-01
Several clinical trials of drug treatment of patients with congestive heart failure (CHF) have previously been reported as Mortality Abstracts in the Journal of Insurance Medicine. Results are presented here for two similar clinical trials reported in September 1999 and compared with the previous results. In a recent international multicenter clinical trial, excess mortality in terms of excess death rates (EDRs) was reduced from 195 per 1000 per year in the placebo group to 139 in the group treated with Spironolactone. There was no significant reduction in the Danish multicenter study of Dofetilide to convert the atrial fibrillation (AF) to a normal rhythm in the 25% of the CHF patients who had AF (EDR was 224 in the placebo group and 216 in the Dofetilide group). In both of these studies, there were more patients with severe CHF than in the previous studies and the EDR values were higher. Results from the Danish study by severity according to the New York Heart Association (NYHA) classification show a progressive increase in EDR from 173 in class 2 to 237 in class 3 to 392 in class 4. Excess mortality in symptomatic CHF is far outside the issue limits for individual life insurance, but these results are of potential utility for the underwriting of such cases for structured settlement annuities.
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Rennie, Drummond; Bossuyt, Patrick M. M.
2008-01-01
Summary Objective The Standards for Reporting of Diagnostic Accuracy (STARD) statement provided guidelines for investigators conducting diagnostic accuracy studies. We reviewed each item in the statement for its applicability to clinical examination diagnostic accuracy research, viewing each discrete aspect of the history and physical examination as a diagnostic test. Setting Nonsystematic review of the STARD statement. Interventions Two former STARD Group participants and 1 editor of a journal series on clinical examination research reviewed each STARD item. Suggested interpretations and comments were shared to develop consensus. Measurements and Main Results The STARD Statement applies generally well to clinical examination diagnostic accuracy studies. Three items are the most important for clinical examination diagnostic accuracy studies, and investigators should pay particular attention to their requirements: describe carefully the patient recruitment process, describe participant sampling and address if patients were from a consecutive series, and describe whether the clinicians were masked to the reference standard tests and whether the interpretation of the reference standard test was masked to the clinical examination components or overall clinical impression. The consideration of these and the other STARD items in clinical examination diagnostic research studies would improve the quality of investigations and strengthen conclusions reached by practicing clinicians. Conclusions The STARD statement provides a very useful framework for diagnostic accuracy studies. The group correctly anticipated that there would be nuances applicable to studies of the clinical examination. We offer guidance that should enhance their usefulness to investigators embarking on original studies of a patient’s history and physical examination. PMID:18347878
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Colder Carras, Michelle; Mojtabai, Ramin; Furr-Holden, C Debra; Eaton, William; Cullen, Bernadette A M
2014-03-01
Recent years have witnessed an expansion of Internet- and mobile-phone-based interventions for health promotion, yet few studies have focused on the use of technology by individuals with mental illness. This study examined the extent to which patients at an inner-city community psychiatry clinic had access to information and communications technology (ICT) and how they used those resources. Patients of an outpatient, inner-city community psychiatry program (N=189) completed a survey that included questions about demographics and ICT use which were adapted from an existing local population-based health survey (community sample, N=968). Frequencies of ICT use were assessed for the clinic sample and questions common to both the surveys completed by the clinic and community samples were compared using logistic regression. Among clinic cases, 105 (55.6%) reported owning or using a computer, 162 (85.7%) reported owning or using a mobile phone, and 112 (59.3%) reportedf using the Internet. Among those who used mobile phones, the majority reported using them daily; 42% of those who used the Internet reported using it several times per day. Differences in frequency of Internet use between samples were not significant, but clinic participants used the Internet more intensively to email, instant message, access health information, and use social media sites. A majority of patients in this community psychiatry clinic sample use ICT. Greater access to and use of the Internet by those with mental illness has important implications for the feasibility and impact of technology-based interventions.
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The ClinicalTrials.gov Results Database — Update and Key Issues
Zarin, Deborah A.; Tse, Tony; Williams, Rebecca J.; Califf, Robert M.; Ide, Nicholas C.
2011-01-01
BACKGROUND The ClinicalTrials.gov trial registry was expanded in 2008 to include a database for reporting summary results. We summarize the structure and contents of the results database, provide an update of relevant policies, and show how the data can be used to gain insight into the state of clinical research. METHODS We analyzed ClinicalTrials.gov data that were publicly available between September 2009 and September 2010. RESULTS As of September 27, 2010, ClinicalTrials.gov received approximately 330 new and 2000 revised registrations each week, along with 30 new and 80 revised results submissions. We characterized the 79,413 registry and 2178 results of trial records available as of September 2010. From a sample cohort of results records, 78 of 150 (52%) had associated publications within 2 years after posting. Of results records available publicly, 20% reported more than two primary outcome measures and 5% reported more than five. Of a sample of 100 registry record outcome measures, 61% lacked specificity in describing the metric used in the planned analysis. In a sample of 700 results records, the mean number of different analysis populations per study group was 2.5 (median, 1; range, 1 to 25). Of these trials, 24% reported results for 90% or less of their participants. CONCLUSIONS ClinicalTrials.gov provides access to study results not otherwise available to the public. Although the database allows examination of various aspects of ongoing and completed clinical trials, its ultimate usefulness depends on the research community to submit accurate, informative data. PMID:21366476
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Gleacher, Alissa A; Olin, Serene S; Nadeem, Erum; Pollock, Michele; Ringle, Vanesa; Bickman, Leonard; Douglas, Susan; Hoagwood, Kimberly
2016-05-01
Measurement feedback systems (MFSs) have been proposed as a means of improving practice. The present study examined the implementation of a MFS, the Contextualized Feedback System (CFS), in two community-based clinic sites. Significant implementation differences across sites provided a basis for examining factors that influenced clinician uptake of CFS. Following the theoretical implementation framework of Aarons et al. (Adm Policy Mental Health Mental Health Serv Res 38(1):4-23, 2011), we coded qualitative data collected from eighteen clinicians (13 from Clinic U and 5 from Clinic R) who participated in semi-structured interviews about their experience with CFS implementation. Results suggest that clinicians at both clinics perceived more barriers than facilitators to CFS implementation. Interestingly, clinicians at the higher implementing clinic reported a higher proportion of barriers to facilitators (3:1 vs. 2:1); however, these clinicians also reported a significantly higher level of organizational and leadership supports for CFS implementation. Implications of these findings are discussed.
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Epidemiology of diabetic retinopathy and maculopathy in Africa: a systematic review
Burgess, P I; MacCormick, I J C; Harding, S P; Bastawrous, A; Beare, N A V; Garner, P
2013-01-01
Abstract Aim To summarize findings from studies reporting the prevalence and incidence of diabetic retinopathy and diabetic maculopathy in African countries in light of the rising prevalence of diabetes mellitus. Methods Using a predefined search strategy, we systematically searched MEDLINE, EMBASE, Science Citation index and Conference Proceedings Citation index, African Index Medicus and the grey literature database ‘OpenSIGLE’ for studies published between January 1990 and February 2011. Included studies reported prevalence or incidence of diabetic retinopathy or diabetic maculopathy of subjects with diabetes resident in African countries. Results Sixty-two studies from 21 countries were included: three population-based surveys; two cohort studies; five case–control studies; 32 diabetes clinic-based, nine eye clinic-based and 11 other hospital-based surveys. Included studies varied considerably in terms of patient selection, method of assessing the eye and retinopathy classification. In population-based studies, the reported prevalence range in patients with diabetes for diabetic retinopathy was 30.2 to 31.6%, proliferative diabetic retinopathy 0.9 to 1.3%, and any maculopathy 1.2 to 4.5%. In diabetes clinic-based surveys, the reported prevalence range for diabetic retinopathy was 7.0 to 62.4%, proliferative diabetic retinopathy 0 to 6.9%, and any maculopathy 1.2 to 31.1%. No obvious association between prevalence and income level of the country was detected. Conclusions Large, community-based cross-sectional and cohort studies are needed to investigate rates and determinants of prevalence of diabetic retinopathy, incidence and progression in Africa. Consensus is needed on the most appropriate methods of identification and classification of retinopathy for research and clinical practice. Estimates of prevalence of diabetic retinopathy, proliferative diabetic retinopathy and maculopathy are comparable with recent European and American studies. PMID:22817387
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Biological augmentation and tissue engineering approaches in meniscus surgery.
Moran, Cathal J; Busilacchi, Alberto; Lee, Cassandra A; Athanasiou, Kyriacos A; Verdonk, Peter C
2015-05-01
The purpose of this review was to evaluate the role of biological augmentation and tissue engineering strategies in meniscus surgery. Although clinical (human), preclinical (animal), and in vitro tissue engineering studies are included here, we have placed additional focus on addressing preclinical and clinical studies reported during the 5-year period used in this review in a systematic fashion while also providing a summary review of some important in vitro tissue engineering findings in the field over the past decade. A search was performed on PubMed for original works published from 2009 to March 31, 2014 using the term "meniscus" with all the following terms: "scaffolds," "constructs," "cells," "growth factors," "implant," "tissue engineering," and "regenerative medicine." Inclusion criteria were the following: English-language articles and original clinical, preclinical (in vivo), and in vitro studies of tissue engineering and regenerative medicine application in knee meniscus lesions published from 2009 to March 31, 2014. Three clinical studies and 18 preclinical studies were identified along with 68 tissue engineering in vitro studies. These reports show the increasing promise of biological augmentation and tissue engineering strategies in meniscus surgery. The role of stem cell and growth factor therapy appears to be particularly useful. A review of in vitro tissue engineering studies found a large number of scaffold types to be of promise for meniscus replacement. Limitations include a relatively low number of clinical or preclinical in vivo studies, in addition to the fact there is as yet no report in the literature of a tissue-engineered meniscus construct used clinically. Neither does the literature provide clarity on the optimal meniscus scaffold type or biological augmentation with which meniscus repair or replacement would be best addressed in the future. There is increasing focus on the role of mechanobiology and biomechanical and biochemical cues in this process, however, and it is hoped that this may lead to improvements in this strategy. There appears to be significant potential for biological augmentation and tissue engineering strategies in meniscus surgery to enhance options for repair and replacement. However, there are still relatively few clinical studies being reported in this regard. There is a strong need for improved translational activities and infrastructure to link the large amounts of in vitro and preclinical biological and tissue engineering data to clinical application. Level IV, systematic review of Level I-IV studies. Copyright © 2015 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.
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McAlindon, T E; Driban, J B; Henrotin, Y; Hunter, D J; Jiang, G-L; Skou, S T; Wang, S; Schnitzer, T
2015-05-01
The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct, and reporting of clinical trials for knee OA we initially drafted recommendations through an iterative process. Members of the working group included representatives from industry and academia. After the working group members reviewed a final draft, they scored the appropriateness for recommendations. After the members voted we calculated the median score among the nine members of the working group who completed the score. The document includes 25 recommendations regarding randomization, blocking and stratification, blinding, enhancing accuracy of patient-reported outcomes (PRO), selecting a study population and index knee, describing interventions, patient-reported and physical performance measures, structural outcome measures, biochemical biomarkers, and reporting recommendations. In summary, the working group identified 25 recommendations that represent the current best practices regarding clinical trials that target symptom or structure modification among individuals with knee OA. These updated recommendations incorporate novel technologies (e.g., magnetic resonance imaging (MRI)) and strategies to address the heterogeneity of knee OA. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
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Information extraction from multi-institutional radiology reports.
Hassanpour, Saeed; Langlotz, Curtis P
2016-01-01
The radiology report is the most important source of clinical imaging information. It documents critical information about the patient's health and the radiologist's interpretation of medical findings. It also communicates information to the referring physicians and records that information for future clinical and research use. Although efforts to structure some radiology report information through predefined templates are beginning to bear fruit, a large portion of radiology report information is entered in free text. The free text format is a major obstacle for rapid extraction and subsequent use of information by clinicians, researchers, and healthcare information systems. This difficulty is due to the ambiguity and subtlety of natural language, complexity of described images, and variations among different radiologists and healthcare organizations. As a result, radiology reports are used only once by the clinician who ordered the study and rarely are used again for research and data mining. In this work, machine learning techniques and a large multi-institutional radiology report repository are used to extract the semantics of the radiology report and overcome the barriers to the re-use of radiology report information in clinical research and other healthcare applications. We describe a machine learning system to annotate radiology reports and extract report contents according to an information model. This information model covers the majority of clinically significant contents in radiology reports and is applicable to a wide variety of radiology study types. Our automated approach uses discriminative sequence classifiers for named-entity recognition to extract and organize clinically significant terms and phrases consistent with the information model. We evaluated our information extraction system on 150 radiology reports from three major healthcare organizations and compared its results to a commonly used non-machine learning information extraction method. We also evaluated the generalizability of our approach across different organizations by training and testing our system on data from different organizations. Our results show the efficacy of our machine learning approach in extracting the information model's elements (10-fold cross-validation average performance: precision: 87%, recall: 84%, F1 score: 85%) and its superiority and generalizability compared to the common non-machine learning approach (p-value<0.05). Our machine learning information extraction approach provides an effective automatic method to annotate and extract clinically significant information from a large collection of free text radiology reports. This information extraction system can help clinicians better understand the radiology reports and prioritize their review process. In addition, the extracted information can be used by researchers to link radiology reports to information from other data sources such as electronic health records and the patient's genome. Extracted information also can facilitate disease surveillance, real-time clinical decision support for the radiologist, and content-based image retrieval. Copyright © 2015 Elsevier B.V. All rights reserved.
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de Bruin, Jeroen S; Zeckl, Julia; Adlassnig, Katharina; Blacky, Alexander; Koller, Walter; Rappelsberger, Andrea; Adlassnig, Klaus-Peter
2017-01-01
The creation of clinical decision support systems has received a strong impulse over the last years, but their integration into a clinical routine has lagged behind, partly due to a lack of interoperability and trust by physicians. We report on the implementation of a clinical foundation framework in Arden Syntax, comprising knowledge units for (a) preprocessing raw clinical data, (b) the determination of single clinical concepts, and (c) more complex medical knowledge, which can be modeled through the composition and configuration of knowledge units in this framework. Thus, it can be tailored to clinical institutions or patients' caregivers. In the present version, we integrated knowledge units for several infection-related clinical concepts into the framework and developed a clinical event monitoring system over the framework that employs three different scenarios for monitoring clinical signs of bloodstream infection. The clinical event monitoring system was tested using data from intensive care units at Vienna General Hospital, Austria.
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Poststroke Seizures and Epilepsy: Clinical Studies and Animal Models
Kelly, Kevin M.
2002-01-01
Poststroke seizures and epilepsy have been described in numerous clinical studies for many years. Most studies are retrospective in design, include relatively small numbers of patients, have limited periods of follow-up, and report a diversity of findings. Well-designed clinical trials and population studies in the recent past addressed several critical clinical issues and generated important findings regarding the occurrence of poststroke seizures and epilepsy. In contrast, the pathophysiologic events of injured brain that establish poststroke epileptogenesis are not well understood, and animal modeling has had limited development. Reviews of several important clinical studies and animal models that hold promise for a better understanding of poststroke epileptogenesis are presented. PMID:15309107
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Rubbo, Bruna; Fitzpatrick, Natalie K; Denaxas, Spiros; Daskalopoulou, Marina; Yu, Ning; Patel, Riyaz S; Hemingway, Harry
2015-01-01
Electronic health records (EHRs) offer the opportunity to ascertain clinical outcomes at large scale and low cost, thus facilitating cohort studies, quality of care research and clinical trials. For acute myocardial infarction (AMI) the extent to which different EHR sources are accessible and accurate remains uncertain. Using MEDLINE and EMBASE we identified thirty three studies, reporting a total of 128658 patients, published between January 2000 and July 2014 that permitted assessment of the validity of AMI diagnosis drawn from EHR sources against a reference such as manual chart review. In contrast to clinical practice, only one study used EHR-derived markers of myocardial necrosis to identify possible AMI cases, none used electrocardiogram findings and one used symptoms in the form of free text combined with coded diagnosis. The remaining studies relied mostly on coded diagnosis. Thirty one studies reported positive predictive value (PPV)≥ 70% between AMI diagnosis from both secondary care and primary care EHRs and the reference. Among fifteen studies reporting EHR-derived AMI phenotypes, three cross-referenced ST-segment elevation AMI diagnosis (PPV range 71-100%), two non-ST-segment elevation AMI (PPV 91.0, 92.1%), three non-fatal AMI (PPV range 82-92.2%) and six fatal AMI (PPV range 64-91.7%). Clinical coding of EHR-derived AMI diagnosis in primary care and secondary care was found to be accurate in different clinical settings and for different phenotypes. However, markers of myocardial necrosis, ECG and symptoms, the cornerstones of a clinical diagnosis, are underutilised and remain a challenge to retrieve from EHRs. Copyright © 2015. Published by Elsevier Ireland Ltd.
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Crawford, Thomas N; Cohen, Patricia; Johnson, Jeffrey G; Kasen, Stephanie; First, Michael B; Gordon, Kathy; Brook, Judith S
2005-02-01
Approximately 800 youths from the Children in the Community Study (Cohen & Cohen, 1996) have been assessed prospectively for over 20 years to study personality disorders (PDs) in adolescents and young adults. In this article we evaluate the Children in the Community Self-Report (CIC-SR) Scales, which were designed to assess DSM-IV PDs using self-reported prospective data from this longitudinal sample. To evaluate convergent validity, we assessed concordance between the CIC-SR Scales and the Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II; First, Gibbon, Spitzer, Williams, & Benjamin, 1995) in 644 participants at mean age 33. To assess predictive validity, we used CIC-SR Scales at mean age 22 to predict subsequent CIC-SR and SCID-II Personality Questionnaire scores at mean age 33. In these analyses the CIC-SR Scales matched or exceeded benchmarks established in previous comparisons between self-report instruments and structured clinical interviews. Unlike other self-report scales, the CIC-SR did not appear to overestimate diagnoses when compared with SCID-II clinical diagnoses.
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Berntsen, G; Lassen, K; Bellika, J G; Wootton, R; Lindsetmo, R O
2011-01-01
Introduction The Consolidated Standards for Reporting Trials (CONSORT) were published to standardize reporting and improve the quality of clinical trials. The objective of this study is to assess CONSORT adherence in randomized clinical trials (RCT) of disease specific clinical decision support (CDS). Methods A systematic search was conducted of the Medline, EMBASE, and Cochrane databases. RCTs on CDS were assessed against CONSORT guidelines and the Jadad score. Result 32 of 3784 papers identified in the primary search were included in the final review. 181 702 patients and 7315 physicians participated in the selected trials. Most trials were performed in primary care (22), including 897 general practitioner offices. RCTs assessing CDS for asthma (4), diabetes (4), and hyperlipidemia (3) were the most common. Thirteen CDS systems (40%) were implemented in electronic medical records, and 14 (43%) provided automatic alerts. CONSORT and Jadad scores were generally low; the mean CONSORT score was 30.75 (95% CI 27.0 to 34.5), median score 32, range 21–38. Fourteen trials (43%) did not clearly define the study objective, and 11 studies (34%) did not include a sample size calculation. Outcome measures were adequately identified and defined in 23 (71%) trials; adverse events or side effects were not reported in 20 trials (62%). Thirteen trials (40%) were of superior quality according to the Jadad score (≥3 points). Six trials (18%) reported on long-term implementation of CDS. Conclusion The overall quality of reporting RCTs was low. There is a need to develop standards for reporting RCTs in medical informatics. PMID:21803926
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Miller, Fiona Alice; Hayeems, Robin Zoe; Li, Li; Bytautas, Jessica Peace
2012-01-01
Even as debate continues about the putative obligation to proactively report genetic research results to study participants, there is an increasing need to attend to the obligations that might cascade from any initial report. We conducted an international, quasi-experimental survey of researchers involved in autism spectrum disorders (ASD) and cystic fibrosis (CF) genetics to explore perceived obligations to ensure updated information or relevant clinical care subsequent to any initial communication of research results, and factors influencing these attitudes. 5-point Likert scales of dis/agreement were analyzed using descriptive and multivariate statistics. Of the 343 respondents (44% response rate), large majorities agreed that in general and in a variety of hypothetical research contexts, research teams that report results should ensure that participants gain subsequent access to updated information (74–83%) and implicated clinical services (79–87%). At the same time, researchers perceived barriers restricting access to relevant clinical care, though this was significantly more pronounced (P<0.001) for ASD (64%) than CF (34%). In the multivariate model, endorsement of cascading obligations was positively associated with researcher characteristics (eg, clinical role/training) and attitudes (eg, perceived initial reporting obligation), and negatively associated with the initial report of less scientifically robust hypothetical results, but unaffected by perceived or hypothetical barriers to care. These results suggest that researchers strongly endorse information and care-based obligations that cascade from the initial report of research results to study participants. In addition, they raise challenging questions about how any cascading obligations are to be met, especially where access challenges are already prevalent. PMID:22333903
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Granulomatous lobular mastitis.
Miliauskas, J R; Pieterse, A S; Williams, R S
1995-02-01
Two cases of benign lobular granulomatous mastitis, both clinically felt to be carcinoma, are reported. One patient was cured by local excision of the mass while the other was cured by oral prednisolone, demonstrating the variable ways to treat this entity. The clinical and histological features were similar to those noted in previous reports. Immunological studies revealed predominantly stromal T lymphocytes and only duct intra-epithelial T lymphocytes.
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ERIC Educational Resources Information Center
Bender, Stacy L.; Privitera, Gregory J.
2016-01-01
This study examined executive function (EF) skills and self-reported symptoms of ADHD. EF skills were measured to determine whether skills were different between groups that reported clinical levels of ADHD symptoms (clinical group) and nonclinical levels of ADHD symptoms (nonclinical group). EF skills in the nonclinical group were also…
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Mofredj, A; Baraka, D
1997-01-01
Although utility of beta-lactams in the treatment of legionnaire's disease could not be demonstrated, clinical cures of human legionellosis with imipenem have been reported. We report the case of a 45-year-old man who presented clinical and radiological features of 'typical' bacterial pneumonia. He was successfully treated with imipenem. Serologic studies showed seroconversion for Legionella pneumophila.
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ERIC Educational Resources Information Center
Queen, Alexander H.; Stewart, Lindsay M.; Ehrenreich-May, Jill; Pincus, Donna B.
2013-01-01
This study examined the independent associations among three family relationship quality factors--cohesion, expressiveness, and conflict--with youth self-reported depressive and anxiety symptoms in a clinical sample of anxious and depressed youth. Ratings of family relationship quality were obtained through both mother and father report. The…
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ERIC Educational Resources Information Center
Timmer, Susan G.; Ho, Lareina K. L.; Urquiza, Anthony J.; Zebell, Nancy M.; Fernandez y Garcia, Erik; Boys, Deanna
2011-01-01
This study uses a multi-method approach to investigate the effectiveness of Parent-Child Interaction Therapy (PCIT) in reducing children's behavior problems when parents report clinical levels of depressive symptoms. Participants were 132 children, 2-7 years of age, and their biological mothers, who either reported low (N = 78) or clinical levels…
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Lindhout, Ingeborg E; Markus, Monica Th; Borst, Sophie R; Hoogendijk, Thea H G; Dingemans, Peter M A J; Boer, Frits
2009-06-01
This study examined whether (1) parents of anxiety-disordered (AD) children differed from those of non-clinical controls in their childrearing style, and whether (2) the child-rearing style of parents towards AD children is different from that towards their siblings. A clinical sample of 25 AD children, age range 8-13 years, was compared with 25 siblings and a non-clinical control group (n = 25). Childrearing was assessed by means of parental self-report, child report and through an expressed emotion interview measure. AD children perceived more parental rejection than non-clinical control children or the AD children's siblings. High-expressed emotion was scored significantly more often towards AD children than non-clinical control children, or their siblings. On [Symbol: see text]care' and [Symbol: see text]control' parental self-report showed some differences regarding AD children on the one hand and non-clinical control children or siblings of AD children on the other. These results suggest that the rearing of AD children differs significantly both from the rearing of their siblings and that of non-clinical control children.
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Combinations of Radiotherapy and Immunotherapy for Melanoma: A Review of Clinical Outcomes
Barker, Christopher A.; Postow, Michael A.
2015-01-01
Radiotherapy has long played a role in the management of melanoma. Recent advances have also demonstrated the efficacy of immunotherapy in the treatment of melanoma. Preclinical data suggest a biologic interaction between radiotherapy and immunotherapy. Several clinical studies corroborate these findings. This review will summarize the outcomes of studies reporting on patients with melanoma treated with a combination of radiotherapy and immunotherapy. Vaccine therapies often use irradiated melanoma cells, and may be enhanced by radiotherapy. The cytokines interferon-alpha and interleukin-2 have been combined with radiotherapy in several small studies, with some evidence suggesting increased toxicity and/or efficacy. Ipilimumab, a monoclonal antibody which blocks cytotoxic T-lymphocyte antigen-4, has been combined with radiotherapy in several notable case studies and series. Finally, pilot studies of adoptive cell transfer have suggested radiotherapy may improve the efficacy of treatment. The review will demonstrate that the combination of radiotherapy and immunotherapy has been reported in several notable case studies, series and clinical trials. These clinical results suggest interaction and the need for further study. PMID:24661650
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Adverse-event profile of Crataegus spp.: a systematic review.
Daniele, Claudia; Mazzanti, Gabriela; Pittler, Max H; Ernst, Edzard
2006-01-01
Crataegus spp. (hawthorn) monopreparations are predominantly used for treating congestive heart failure. The effectiveness of hawthorn preparations (flowers with leaves; berries) is documented in a number of clinical studies, reviews and meta-analyses. The aim of this article is to assess the safety data of all available human studies on hawthorn monopreparations. Systematic searches were conducted on MEDLINE, EMBASE, AMED, The Cochrane Library, the UK National Research Register and the US ClinicalTrials.gov (up to January 2005). Data were requested from the spontaneous reporting scheme of the WHO. Hand searches were also conducted in a sample of relevant medical journals, conference proceedings, reference lists of identified articles and our own files. Eight manufacturers of hawthorn-containing preparations were contacted and asked to supply any information on adverse events or drug interactions. Data from all clinical studies and reports were assessed. Only human studies on monopreparations were included. Data from hawthorn-containing combination preparations and homeopathic preparations were excluded. All studies were read and evaluated by one reviewer and independently verified by at least one additional reviewer.Twenty-nine clinical studies were identified, of which 24 met our inclusion criteria. A total of 7311 patients were enrolled, and data from 5,577 patients were available for analysis. The daily dose and duration of treatment with hawthorn monopreparations ranged from 160 to 1,800 mg and from 3 to 24 weeks, respectively. The extracts most used in the clinical trials were WS 1,442 (extract of hawthorn standardised to 18.75% oligomeric procyanidins) and LI 132 (extract of hawthorn standardised to 2.25% flavonoids). Overall, 166 adverse events were reported. Most of these adverse events were, in general, mild to moderate; eight severe adverse events have been reported with the LI 132 extract. The most frequent adverse events were dizziness/vertigo (n = 15), gastrointestinal complaints (n = 24), headache (n = 9), migraine (n = 8) and palpitation (n = 11). The WHO spontaneous reporting scheme received 18 case reports. In the identified trials, the most frequent adverse events were dizziness (n = 6), nausea (n = 5), fall (n = 2), gastrointestinal haemorrhage (n = 2), circulation failure (n = 2) and erythematous rash (n = 2). There were no reports of drug interactions. In conclusion, all data reviewed in this article seem to indicate that hawthorn is well tolerated even if some severe adverse events were reported; this suggests that further studies are needed to better assess the safety of hawthorn-containing preparations. Moreover, the unsupervised use of this drug can be associated with problems, especially if given with concomitant medications.
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Basch, Ethan; Pugh, Stephanie L; Dueck, Amylou C; Mitchell, Sandra A; Berk, Lawrence; Fogh, Shannon; Rogak, Lauren J; Gatewood, Marcha; Reeve, Bryce B; Mendoza, Tito R; O’Mara, Ann; Denicoff, Andrea; Minasian, Lori; Bennett, Antonia V; Setser, Ann; Schrag, Deborah; Roof, Kevin; Moore, Joan K; Gergel, Thomas; Stephans, Kevin; Rimner, Andreas; DeNittis, Albert; Bruner, Deborah Watkins
2017-01-01
Purpose To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Methods and Materials Patients enrolled in Trial XXXX (XXXX) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly x4 during treatment; 12-weeks post-treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visits when an expected PRO-CTCAE assessment was completed. Results Among 226 study sites participating in Trial XXXX, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients of which 34 (43%) required tablet computers to be provided. All 152 patients in Trial XXXX agreed to self-report using the PRO-CTCAE (median age 66; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range 30–240), and median time for CRAs to teach a patient to self-report was 10 minutes (range 2–60). Compliance was high, particularly during active treatment when patients self-reported at 86% of expected time points, although compliance was lower post-treatment (72%). Common reasons for non-compliance were institutional errors such as forgetting to provide computers to participants; patients missing clinic visits; internet connectivity; and patients feeling “too sick”. Conclusions Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic adverse events at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be obviated by allowing patients to self-report electronically between-visits, and by employing central compliance monitoring. These approaches are being incorporated into ongoing studies. PMID:28463161
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Efficace, Fabio; Feuerstein, Michael; Fayers, Peter; Cafaro, Valentina; Eastham, James; Pusic, Andrea; Blazeby, Jane
2014-09-01
Patient-reported outcomes (PRO) data from randomised controlled trials (RCTs) are increasingly used to inform patient-centred care as well as clinical and health policy decisions. The main objective of this study was to investigate the methodological quality of PRO assessment in RCTs of prostate cancer (PCa) and to estimate the likely impact of these studies on clinical decision making. A systematic literature search of studies was undertaken on main electronic databases to retrieve articles published between January 2004 and March 2012. RCTs were evaluated on a predetermined extraction form, including (1) basic trial demographics and clinical and PRO characteristics; (2) level of PRO reporting based on the recently published recommendations by the International Society for Quality of Life Research; and (3) bias, assessed using the Cochrane Risk of Bias tool. Studies were systematically analysed to evaluate their relevance for supporting clinical decision making. Sixty-five RCTs enrolling a total of 22 071 patients were evaluated, with 31 (48%) in patients with nonmetastatic disease. When a PRO difference between treatments was found, it related in most cases to symptoms only (n=29, 58%). Although the extent of missing data was generally documented (72% of RCTs), few reported details on statistical handling of this data (18%) and reasons for dropout (35%). Improvements in key methodological aspects over time were found. Thirteen (20%) RCTs were judged as likely to be robust in informing clinical decision making. Higher-quality PRO studies were generally associated with those RCTs that had higher internal validity. Including PRO in RCTs of PCa patients is critical for better evaluating the treatment effectiveness of new therapeutic approaches. Marked improvements in PRO quality reporting over time were found, and it is estimated that at least one-fifth of PRO RCTs have provided sufficient details to allow health policy makers and physicians to make critical appraisals of results. In this report, we have investigated the methodological quality of PCa trials that have included a PRO assessment. We conclude that including PRO is critical to better evaluating the treatment effectiveness of new therapeutic approaches from the patient's perspective. Also, at least one-fifth of PRO RCTs in PCa have provided sufficient details to allow health policy makers and physicians to make a critical appraisal of results. Copyright © 2013. Published by Elsevier B.V.
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ERIC Educational Resources Information Center
Curran, Vernon R.; Butler, Roger; Duke, Pauline; Eaton, William H.; Moffatt, Scott M.; Sherman, Greg P.; Pottle, Madge
2012-01-01
Clinical competence is a multidimensional concept and encompasses a variety of skills including procedural, problem-solving and clinical judgement. The initial stages of postgraduate medical training are believed to be a particularly important time for the development of clinical skill competencies. This study reports on an evaluation of a…
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Pareés, Isabel
2017-11-01
This clinical commentary discusses the phenomenology and treatment of paroxysmal dyskinesia in patients with multiple sclerosis. It calls for a consensus on the definition as well as for larger studies to better understand this unusual clinical association.
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Edmonstone, J; Chisnell, C
1992-01-01
The creation of clinical directorates in acute hospital services has directed attention towards the clinical director role. The two "support" roles of clinical nurse manager and business manager have received less attention. Reports on an action research study into these roles, examining recruitment and selection, monitoring of performance, training needs and succession planning. Deals with the clinical nurse manager role.
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Sex Differences in Reported Pain Across 11,000 Patients Captured in Electronic Medical Records
Ruau, David; Liu, Linda Y.; Clark, J. David; Angst, Martin S.; Butte, Atul J.
2011-01-01
Clinically recorded pain scores are abundant in patient health records but are rarely used in research. The use of this information could help improve clinical outcomes. For example, a recent report by the Institute of Medicine stated that ineffective use of clinical information contributes to under-treatment of patient subpopulations — especially women. This study used diagnosis-associated pain scores from a large hospital database to document sex differences in reported pain. We used de-identified electronic medical records from Stanford Hospital and Clinics for more than 72,000 patients. Each record contained at least one disease-associated pain score. We found over 160,000 pain scores in more than 250 primary diagnoses, and analyzed differences in disease-specific pain reported by men and women. After filtering for diagnoses with minimum encounter numbers, we found diagnosis-specific sex differences in reported pain. The most significant differences occurred in patients with disorders of the musculoskeletal, circulatory, respiratory and digestive systems, followed by infectious diseases, and injury and poisoning. We also discovered sex-specific differences in pain intensity in previously unreported diseases, including disorders of the cervical region, and acute sinusitis (p = 0.01, 0.017, respectively). Pain scores were collected during hospital encounters. No information about the use of pre-encounter over-the-counter medications was available. To our knowledge, this is the largest data-driven study documenting sex differences of disease-associated pain. It highlights the utility of EMR data to corroborate and expand on results of smaller clinical studies. Our findings emphasize the need for future research examining the mechanisms underlying differences in pain. PMID:22245360
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2013-01-01
Background Work-related musculoskeletal disorders are one of the main occupational health hazards affecting dental practitioners. This study was conducted to assess the prevalence of Work-related Musculoskeletal Disorder (WMSD) amongst dental students. Possible correlations with the working environment and ergonomics taught in Malaysian dental schools were also sought. Methods Five dental schools in Malaysia participated in this cross-sectional study. A validated self-administered questionnaire was used to establish the point prevalence of WMSD in the dental students based on various body regions. The questionnaire also collected data regarding the working environment, clinical practice and the taught ergonomics of the students during their training years. Results Out of five hundred and sixty eight dental students who participated in the study, 410 were in their clinical years whilst 158 were students in their non- clinical years. Ninety three percent of the clinical year students reported symptoms of WMSD in one or more body regions. Female students reported a significantly higher numbers of symptoms compared to male students. The neck (82%) and lower back (64%) were reported to have the highest prevalence of WMSD. Discomfort in the neck region was found to be associated with self-reported frequency of bending of the neck. A majority of students (92%) reported minimum participation in workshops related to ergonomics in dentistry and 77% were unfamiliar with treatment and remedies available in the case of WMSD. Conclusions There was more WMSD seen in dental students who had started their clinical years. Neck and lower back are more injury prone areas and are at increased risk of developing musculoskeletal disorders. Theory and practice of ergonomics should be incorporated into the dental undergraduate curriculum. PMID:23547959
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Khan, Saad A; Chew, Kwai Yee
2013-04-02
Work-related musculoskeletal disorders are one of the main occupational health hazards affecting dental practitioners. This study was conducted to assess the prevalence of Work-related Musculoskeletal Disorder (WMSD) amongst dental students. Possible correlations with the working environment and ergonomics taught in Malaysian dental schools were also sought. Five dental schools in Malaysia participated in this cross-sectional study. A validated self-administered questionnaire was used to establish the point prevalence of WMSD in the dental students based on various body regions. The questionnaire also collected data regarding the working environment, clinical practice and the taught ergonomics of the students during their training years. Out of five hundred and sixty eight dental students who participated in the study, 410 were in their clinical years whilst 158 were students in their non- clinical years. Ninety three percent of the clinical year students reported symptoms of WMSD in one or more body regions. Female students reported a significantly higher numbers of symptoms compared to male students. The neck (82%) and lower back (64%) were reported to have the highest prevalence of WMSD. Discomfort in the neck region was found to be associated with self-reported frequency of bending of the neck. A majority of students (92%) reported minimum participation in workshops related to ergonomics in dentistry and 77% were unfamiliar with treatment and remedies available in the case of WMSD. There was more WMSD seen in dental students who had started their clinical years. Neck and lower back are more injury prone areas and are at increased risk of developing musculoskeletal disorders. Theory and practice of ergonomics should be incorporated into the dental undergraduate curriculum.
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Variation in Private Payer Coverage of Rheumatoid Arthritis Drugs.
Chambers, James D; Wilkinson, Colby L; Anderson, Jordan E; Chenoweth, Matthew D
2016-10-01
Payers in the United States issue coverage determinations to guide how their enrolled beneficiaries use prescription drugs. Because payers create their own coverage policies, how they cover drugs can vary, which in turn can affect access to care by beneficiaries. To examine how the largest private payers based on membership cover drugs indicated for rheumatoid arthritis and to determine what evidence the payers reported reviewing when formulating their coverage policies. Coverage policies issued by the 10 largest private payers that make their policies publicly available were identified for rheumatoid arthritis drugs. Each coverage determination was compared with the drug's corresponding FDA label and categorized according to the following: (a) consistent with the label, (b) more restrictive than the label, (c) less restrictive than the label, or (d) mixed (i.e., more restrictive than the label in one way but less restrictive in another). Each coverage determination was also compared with the American College of Rheumatology (ACR) 2012 treatment recommendations and categorized using the same relative restrictiveness criteria. The policies were then reviewed to identify the evidence that the payers reported reviewing. The identified evidence was divided into the following 6 categories: randomized controlled trials; other clinical studies (e.g., observational studies); health technology assessments; clinical reviews; cost-effectiveness analyses; and clinical guidelines. Sixty-nine percent of coverage determinations were more restrictive than the corresponding FDA label; 15% were consistent; 3% were less restrictive; and 13% were mixed. Thirty-four percent of coverage determinations were consistent with the ACR recommendations, 33% were more restrictive; 17% were less restrictive; and 17% were mixed. Payers most often reported reviewing randomized controlled trials for their coverage policies (an average of 2.3 per policy). The payers reported reviewing an average of 1.4 clinical guidelines, 1.1 clinical reviews, 0.8 other clinical studies, and 0.5 technology assessments per policy. Only 1 payer reported reviewing cost-effectiveness analyses. The evidence base that the payers reported reviewing varied in terms of volume and composition. Payers most often covered rheumatoid arthritis drugs more restrictively than the corresponding FDA label indication and the ACR treatment recommendations. Payers reported reviewing a varied evidence base in their coverage policies. Funding for this study was provided by Genentech. Chambers has participated in a Sanofi advisory board, unrelated to this study. The authors report no other potential conflicts of interest. Study concept and design were contributed by Chambers. Anderson, Wilkinson, and Chenoweth collected the data, assisted by Chambers, and data interpretation was primarily performed by Chambers, along with Anderson and with assistance from Wilkinson and Chenoweth. The manuscript was written primarily by Chambers, along with Wilkinson and with assistance from Anderson and Chenoweth. Chambers, Chenoweth, Wilkinson, and Anderson revised the manuscript.
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Najjar, Peter; Kachalia, Allen; Sutherland, Tori; Beloff, Jennifer; David-Kasdan, Jo Ann; Bates, David W; Urman, Richard D
2015-01-01
The AHRQ Patient Safety Indicators (PSIs) are used for calculation of risk-adjusted postoperative rates for adverse events. The payers and quality consortiums are increasingly requiring public reporting of hospital performance on these metrics. We discuss processes designed to improve the accuracy and clinical utility of PSI reporting in practice. The study was conducted at a 793-bed tertiary care academic medical center where PSI processes have been aggressively implemented to track patient safety events at discharge. A three-phased approach to improving administrative data quality was implemented. The initiative consisted of clinical review of all PSIs, documentation improvement, and provider outreach including active querying for patient safety events. This multidisciplinary effort to develop a streamlined process for PSI calculation reduced the reporting of miscoded PSIs and increased the clinical utility of PSI monitoring. Over 4 quarters, 4 of 41 (10%) PSI-11 and 9 of 138 (7%) PSI-15 errors were identified on review of clinical documentation and appropriate adjustments were made. A multidisciplinary, phased approach leveraging existing billing infrastructure for robust metric coding, ongoing clinical review, and frontline provider outreach is a novel and effective way to reduce the reporting of false-positive outcomes and improve the clinical utility of PSIs.
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Crosby, Richard; DiClemente, Ralph J.; Yarber, William L.; Snow, Gregory; Troutman, Adewale
2009-01-01
This study tested the research hypothesis that men’s errors using condoms would be associated with having multiple sex partners. Specifically, men engaging in sex with three or more women were compared to those having sex with two or fewer women. Recruitment (N=271) occurred in a publicly-funded STD clinic located in a metropolitan area of the Southern U.S. All men were clinically diagnosed with a STD. Men completed a self-reported questionnaire (using a three-month recall period). Those reporting sex with men were excluded from the analysis leaving an analytic sample of 264 men. About one-half of the men (48.5%) reporting penetrative sex with three or more women during the recall period. Compared to those men reporting sex with two or fewer women, men having ≥3 women sex partners were significantly more likely to report: 1) not using condoms from start to finish of sex (P=.005); 2) that condoms slipped off during sex or withdrawal (P=.04); and 3) that condoms broke during sex (P=.03). A summary measure of condom use errors indicated that men with ≥3 women partners reported significantly greater numbers of errors than their counterparts reporting sex with ≤ 2 sex partners (Mean difference 1.7; P=.009). Among young African American men, newly diagnosed with an STD, reporting recent (past three months) sex with multiple partners may be emblematic of condom errors. These men may benefit from, clinic-based, targeted counseling and education designed to foster improved quality of condom use. PMID:19477797
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Cook, Karon F; Jensen, Sally E; Schalet, Benjamin D; Beaumont, Jennifer L; Amtmann, Dagmar; Czajkowski, Susan; Dewalt, Darren A; Fries, James F; Pilkonis, Paul A; Reeve, Bryce B; Stone, Arthur A; Weinfurt, Kevin P; Cella, David
2016-05-01
To present an overview of a series of studies in which the clinical validity of the National Institutes of Health's Patient Reported Outcome Measurement Information System (NIH; PROMIS) measures was evaluated, by domain, across six clinical populations. Approximately 1,500 individuals at baseline and 1,300 at follow-up completed PROMIS measures. The analyses reported in this issue were conducted post hoc, pooling data across six previous studies, and accommodating the different designs of the six, within-condition, parent studies. Changes in T-scores, standardized response means, and effect sizes were calculated in each study. When a parent study design allowed, known groups validity was calculated using a linear mixed model. The results provide substantial support for the clinical validity of nine PROMIS measures in a range of chronic conditions. The cross-condition focus of the analyses provided a unique and multifaceted perspective on how PROMIS measures function in "real-world" clinical settings and provides external anchors that can support comparative effectiveness research. The current body of clinical validity evidence for the nine PROMIS measures indicates the success of NIH PROMIS in developing measures that are effective across a range of chronic conditions. Copyright © 2016 Elsevier Inc. All rights reserved.
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Kates, Steven A; Lader, Alan S; Casale, Ralph; Beeuwkes, Reinier
2014-01-01
CMX-2043 is an α-lipoic acid analogue targeted to reduction of cellular injury and organ damage due to ischaemia–reperfusion injury (IRI). It has been shown to be effective in a rat model of cardiac IRI. The studies here reported evaluate its safety and pharmacokinetic profile in preparation for human clinical studies in procedures associated with IRI. Safety and tolerability were tested in standard pre-clinical in vitro and animal models and in a Phase 1 human clinical trial. CMX-2043 did not bind to a wide range of receptors and specific targets at approximately 4 μg/mL (10 μM). It was not mutagenic by Ames assay, did not produce chromosome aberrations in Chinese hamster ovary (CHO) cells, and was negative for clastogenic potential. Toxicological studies in rats including both single and 14-day repeat intravenous doses and in dogs (single intravenous dose) with a 2-week recovery period were conducted. The NOAEL in rats and dogs was 30 and >10 mg/kg, respectively. No serious adverse events were reported in a placebo-controlled, sequential dose escalation Phase 1 clinical trial. The low toxicity in the pre-clinical studies and the absence of adverse events in the Phase 1 trial have supported investigation of CMX-2043 in a human efficacy trial. PMID:24751172
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Wang, Michael T. M.; Bolland, Mark J.; Gamble, Greg; Grey, Andrew
2015-01-01
Background Publication of clinical research findings in prominent journals influences health beliefs and medical practice, in part by engendering news coverage. Randomized controlled trials (RCTs) should be most influential in guiding clinical practice. We determined whether study design of clinical research published in high-impact journals influences media coverage. Methods and Findings We compared the incidence and amount of media coverage of RCTs with that of observational studies published in the top 7 medical journals between 1 January 2013 and 31 March 2013. We specifically assessed media coverage of the most rigorous RCTs, those with >1000 participants that reported ‘hard’ outcomes. There was no difference between RCTs and observational studies in coverage by major newspapers or news agencies, or in total number of news stories generated (all P>0.63). Large RCTs reporting ‘hard’ outcomes did not generate more news coverage than small RCTs that reported surrogate outcomes and observational studies (all P>0.32). RCTs were more likely than observational studies to attract a journal editorial (70% vs 46%, P = 0.003), but less likely to be the subject of a journal press release (17% vs 50%, P<0.001). Large RCTs that reported ‘hard’ outcomes did not attract an editorial more frequently than other studies (61% vs 58%, P>0.99), nor were they more likely to be the subject of a journal press release (14% vs 38%, P = 0.14). Conclusions The design of clinical studies whose results are published in high-impact medical journals is not associated with the likelihood or amount of ensuing news coverage. PMID:26701758
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Drake, Gareth; de C Williams, Amanda C
2017-02-01
The objective of this review was to examine the effects of nursing education interventions on clinical outcomes for acute pain management in hospital settings, relating interventions to health care behavior change theory. Three databases were searched for nursing education interventions from 2002 to 2015 in acute hospital settings with clinical outcomes reported. Methodological quality was rated as strong, moderate, or weak using the Effective Public Health Practice Project Quality Assessment Tool for quantitative studies. The 12 eligible studies used varied didactic and interactive teaching methods. Several studies had weaknesses attributable to selection biases, uncontrolled confounders, and lack of blinding of outcome assessors. No studies made reference to behavior change theory in their design. Eight of the 12 studies investigated nursing documentation of pain assessment as the main outcome, with the majority reporting positive effects of education interventions on nursing pain assessment. Of the remaining studies, two reported mixed findings on patient self-report of pain scores as the key measure, one reported improvements in patient satisfaction with pain management after a nursing intervention, and one study found an increase in nurses' delivery of a relaxation treatment following an intervention. Improvements in design and evaluation of nursing education interventions are suggested, drawing on behavior change theory and emphasizing the relational, contextual, and emotionally demanding nature of nursing pain management in hospital settings. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.
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The role of social media in clinical excellence.
Batt-Rawden, Samantha; Flickinger, Tabor; Weiner, John; Cheston, Christine; Chisolm, Margaret
2014-07-01
The provision of excellent patient care is a goal shared by all doctors. The role of social media (SM) in helping medical students and doctors achieve clinical excellence is unknown. Social media may help facilitate the achievement of clinical excellence This report aimed to identify examples of how SM may be used to help promote the achievement of clinical excellence in medical learners. Three of the authors previously conducted a systematic review of the published literature on SM use in undergraduate, graduate and continuing medical education. Two authors re-examined the 14 evaluative studies to identify any examples of SM use that may facilitate the achievement of clinical excellence and to consider whether there were any aspects of clinical excellence for which no studies had been performed, and, if so, whether SM was relevant to these domains. Each study touched on one or more of the following domains of clinical excellence: communication and interpersonal skills; professionalism and humanism; knowledge; diagnostic acumen; exhibiting a passion for patient care; a scholarly approach to clinical practice; and explicitly modelling expertise to medical trainees. No study addressed the role of SM to promote the skillful negotiation of the health care system, and in collaboration with investigators to advance science and discovery; however, additional evidence suggested that SM may play an adjunctive role in promoting the achievement of these aspects of clinical excellence. This report supports the hypothesis that SM may help facilitate the achievement of clinical excellence; however, further research is needed into the role of SM in promoting the achievement of clinical excellence. © 2014 John Wiley & Sons Ltd.
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Racial and ethnic disparity in food allergy in the United States: a systematic review.
Greenhawt, Matthew; Weiss, Christopher; Conte, Marisa L; Doucet, Marlie; Engler, Amy; Camargo, Carlos A
2013-01-01
The prevalence of food allergy is rising among US children. Little is known about racial/ethnic disparities in food allergy. We performed a systematic literature review to understand racial/ethnic disparities in food allergy in the United States. We searched PubMed/MEDLINE, Embase, and Scopus for original data about racial/ethnic disparities in the diagnosis, prevalence, treatment, or clinical course of food allergy or sensitization, with a particular focus on black (African American) race. Articles were analyzed by study methodology, racial/ethnic composition, food allergy definition, outcomes, summary statistic used, and covariate adjustment. Twenty of 645 identified articles met inclusion criteria. The studies used multiple differing criteria to define food allergy, including self-report, sensitization assessed by serum food-specific IgE to selected foods without corroborating history, discharge codes, clinic chart review, and event-reporting databases. None used oral food challenge. In 12 studies, black persons (primarily children) had significantly increased adjusted odds of food sensitization or significantly higher proportion or odds of food allergy by self-report, discharge codes, or clinic-based chart review than white children. Major differences in study methodology and reporting precluded calculation of a pooled estimate of effect. Sparse and methodologically limited data exist about racial/ethnic disparity in food allergy in the United States. Available data lack a common definition for food allergy and use indirect measures of allergy, not food challenge. Although data suggest an increased risk of food sensitization, self-reported allergy, or clinic-based diagnosis of food allergy among black children, no definitive racial/ethnic disparity could be found among currently available studies. Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
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Boudard, Aurélie; Martelli, Nicolas; Prognon, Patrice; Pineau, Judith
2013-08-01
Like health technology assessment (HTA) agencies, hospitals are faced with requests for innovative and costly medical devices. However, local decision makers are frequently confronted with a lack of high-quality clinical data when assessing the effectiveness of innovative medical devices. The aim of this study was to quantify the level of evidence available for innovative medical devices in the context of hospital-based HTA. We searched the Medline, Embase and Cochrane Library databases for articles, letters and reports relating to 32 innovative medical devices requested at our hospital between January 2008 and March 2012. All clinical studies retrieved were screened and classified according to the Sackett 5-point level-of-evidence scale. We screened and classified 217 studies: 215 clinical trials and 2 cost-effectiveness studies. Only 47 of the 215 clinical studies (22%) provided high-level clinical evidence (levels 1-2); 33 (15%) were randomized controlled trials (RCTs). More than half of the 215 studies (52.1%) included fewer than 30 patients. Only 14 of the 47 high-quality studies reported the amount of missing data. For implantable medical devices, 84 (71.8%) studies specified the follow-up period and the mean follow-up period was 18.9 months. Finally, methodological quality did not increase with the risk level of the medical device. Our findings confirm that only a few studies of innovative medical devices provide high-level clinical evidence. Nevertheless, RCT may be the 'gold standard' for drugs, but it is not always appropriate for medical devices. Changes to the European regulation of medical devices, with the requirement for a demonstration of clinical efficacy and safety before release onto the European market, have raised expectations. © 2013 John Wiley & Sons Ltd.
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Reducing the blame culture through clinical audit in nuclear medicine: a mixed methods study.
Ross, P; Hubert, J; Wong, W L
2017-02-01
To identify the barriers and facilitators of doctors' engagement with clinical audit and to explore how and why these factors influenced doctors' decisions to engage with the NHS National Clinical Audit Programme. A single-embedded case study. Mixed methods sequential approach with explorative pilot study and follow-up survey. Pilot study comprised 13 semi-structured interviews with purposefully selected consultant doctors over a six-month period. Interview data coded and analysed using directed thematic content analysis with themes compared against the study's propositions. Themes derived from the pilot study informed the online survey question items. Exploratory factor analysis using STATA and descriptive statistical methods applied to summarise findings. Data triangulation techniques used to corroborate and validate findings across the different methodological techniques. NHS National PET-CT Clinical Audit Programme. Doctors reporting on the Audit Programme. Extent of engagement with clinical audit, factors that influence engagement with clinical audit. Online survey: 58/59 doctors responded (98.3%). Audit was found to be initially threatening (79%); audit was reassuring (85%); audit helped validate professional competence (93%); participation in audit improved reporting skills (76%). Three key factors accounted for 97.6% of the variance in survey responses: (1) perception of audit's usefulness, (2) a common purpose, (3) a supportive blame free culture of trust. Factor 1 influenced medical engagement most. The study documents performance feedback as a key facilitator of medical engagement with clinical audit. It found that medical engagement with clinical audit was associated with reduced levels of professional anxiety and higher levels of perceived self-efficacy.
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2013-01-01
Background Non-tuberculous mycobacteria (NTM) are opportunistic pathogens in immuno-compromised patients. They are also increasingly recognized as pathogens in immuno-competent individuals. Globally, an increase in NTM isolation is being reported with a varied geographic prevalence of different species around the world. There is lack of data on species distribution of these organisms from Pakistan. Treatment options differ according to the species isolated and its susceptibility profile. Knowledge of local species variation would help targeted therapy. This study was performed to determine frequencies of different NTM species isolated from various clinical specimens submitted at a tertiary care hospital laboratory. Methods NTM isolated from 25955 clinical specimens over a period of two years (2010 to 2011) were included. All NTM were identified using conventional tests. Drug susceptibility testing (DST) was performed by broth microdilution and interpreted according to Clinical and Laboratory Standards Institute’s document M24-A2. Results A total of 104 NTM were included in the study. Of these, 76% (54/71) rapidly growing mycobacteria (RGM) and 57.6% (19/33) slow growing mycobacteria (SGM) could be further identified. Mycobacterium fortuitum (21/54) was the commonest NTM identified among RGM followed by M. mucogenicum (12/54) and M. smegmatis (11/54). Among SGM, M. avium complex (MAC) was the most frequent (14/19). Clinical significance could be assessed in a limited number (52/104) of NTM isolates and MAC appeared to be the commonest significant NTM. Three extra-pulmonary cases were found to be healthcare associated infections. DST results for RGM showed susceptibility to amikacin (100%), clarithromycin (100%, except M. fortuitum where it is not reportable), linezolid (90%) and moxifloxacin (75%). Whereas SGM were susceptible to clarithromycin (100%), linezolid (58.8%) and moxifloxacin (64.7%). Conclusion This is the first study reporting NTM species and their clinical significance isolated from clinical specimens from Pakistan. Isolation of NTM from clinical specimens should prompt to evaluate their clinical significance. PMID:24148198
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Ahmed, Imran; Jabeen, Kauser; Hasan, Rumina
2013-10-22
Non-tuberculous mycobacteria (NTM) are opportunistic pathogens in immuno-compromised patients. They are also increasingly recognized as pathogens in immuno-competent individuals. Globally, an increase in NTM isolation is being reported with a varied geographic prevalence of different species around the world. There is lack of data on species distribution of these organisms from Pakistan. Treatment options differ according to the species isolated and its susceptibility profile. Knowledge of local species variation would help targeted therapy. This study was performed to determine frequencies of different NTM species isolated from various clinical specimens submitted at a tertiary care hospital laboratory. NTM isolated from 25955 clinical specimens over a period of two years (2010 to 2011) were included. All NTM were identified using conventional tests. Drug susceptibility testing (DST) was performed by broth microdilution and interpreted according to Clinical and Laboratory Standards Institute's document M24-A2. A total of 104 NTM were included in the study. Of these, 76% (54/71) rapidly growing mycobacteria (RGM) and 57.6% (19/33) slow growing mycobacteria (SGM) could be further identified. Mycobacterium fortuitum (21/54) was the commonest NTM identified among RGM followed by M. mucogenicum (12/54) and M. smegmatis (11/54). Among SGM, M. avium complex (MAC) was the most frequent (14/19). Clinical significance could be assessed in a limited number (52/104) of NTM isolates and MAC appeared to be the commonest significant NTM. Three extra-pulmonary cases were found to be healthcare associated infections. DST results for RGM showed susceptibility to amikacin (100%), clarithromycin (100%, except M. fortuitum where it is not reportable), linezolid (90%) and moxifloxacin (75%). Whereas SGM were susceptible to clarithromycin (100%), linezolid (58.8%) and moxifloxacin (64.7%). This is the first study reporting NTM species and their clinical significance isolated from clinical specimens from Pakistan. Isolation of NTM from clinical specimens should prompt to evaluate their clinical significance.
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2014-01-01
Background Although G6PDd individuals are generally asymptomatic throughout their life, the clinical burden of this genetic condition includes a range of haematological conditions, including acute haemolytic anaemia (AHA), neonatal jaundice (NNJ) and chronic non-sphaerocytic anaemia (CNSA). In Latin America (LA), the huge knowledge gap regarding G6PDd is related to the scarce understanding of the burden of clinical manifestation underlying G6PDd carriage. The aim of this work was to study the clinical significance of G6PDd in LA and the Caribbean region through a systematic review. Methods A systematic search of the published literature was undertaken in August 2013. Bibliographies of manuscripts were also searched and additional references were identified. Only original research was included. All study designs were included, as long as any clinical information was present. Studies were eligible for inclusion if they reported clinical information from populations living in LA or Caribbean countries or about migrants from these countries living in countries outside this continent. Results The Medline search generated 487 papers, and the LILACS search identified 140 papers. After applying the inclusion criteria, 100 original papers with any clinical information on G6PDd in LA were retrieved. Additionally, 16 articles were included after reading the references from these papers. These 116 articles reported data from 18 LA and Caribbean countries. The major clinical manifestations reported from LA countries were those related to AHA, namely drug-induced haemolysis. Most of the published works regarding drug-induced haemolysis in LA referred to haemolytic crises in P. vivax malaria patients during the course of the treatment with primaquine (PQ). Favism, infection-induced haemolysis, NNJ and CNSA appear to play only a minor public health role in this continent. Conclusion Haemolysis in patients using PQ seems to be the major clinical manifestation of G6PDd in LA and contributes to the morbidity of P. vivax infection in this continent, although the low number of reported cases, which could be linked to under-reporting of complications. These results support the need for better strategies to diagnose and manage G6PDd in malaria field conditions. Additionally, Malaria Control Programmes in LA should not overlook this condition in their national guidelines. PMID:24568147
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The Effect of Ginger (Zingiber officinale) on Platelet Aggregation: A Systematic Literature Review.
Marx, Wolfgang; McKavanagh, Daniel; McCarthy, Alexandra L; Bird, Robert; Ried, Karin; Chan, Alexandre; Isenring, Liz
2015-01-01
The potential effect of ginger on platelet aggregation is a widely-cited concern both within the published literature and to clinicians; however, there has been no systematic appraisal of the evidence to date. Using the PRISMA guidelines, we systematically reviewed the results of clinical and observational trials regarding the effect of ginger on platelet aggregation in adults compared to either placebo or baseline data. Studies included in this review stipulated the independent variable was a ginger preparation or isolated ginger compound, and used measures of platelet aggregation as the primary outcome. Ten studies were included, comprising eight clinical trials and two observational studies. Of the eight clinical trials, four reported that ginger reduced platelet aggregation, while the remaining four reported no effect. The two observational studies also reported mixed findings. Many of the studies appraised for this review had moderate risks of bias. Methodology varied considerably between studies, notably the timeframe studied, dose of ginger used, and the characteristics of subjects recruited (e.g. healthy vs. patients with chronic diseases). The evidence that ginger affects platelet aggregation and coagulation is equivocal and further study is needed to definitively address this question.
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The Effect of Ginger (Zingiber officinale) on Platelet Aggregation: A Systematic Literature Review
Marx, Wolfgang; McKavanagh, Daniel; McCarthy, Alexandra L.; Bird, Robert; Ried, Karin; Chan, Alexandre; Isenring, Liz
2015-01-01
Background The potential effect of ginger on platelet aggregation is a widely-cited concern both within the published literature and to clinicians; however, there has been no systematic appraisal of the evidence to date. Methods Using the PRISMA guidelines, we systematically reviewed the results of clinical and observational trials regarding the effect of ginger on platelet aggregation in adults compared to either placebo or baseline data. Studies included in this review stipulated the independent variable was a ginger preparation or isolated ginger compound, and used measures of platelet aggregation as the primary outcome. Results Ten studies were included, comprising eight clinical trials and two observational studies. Of the eight clinical trials, four reported that ginger reduced platelet aggregation, while the remaining four reported no effect. The two observational studies also reported mixed findings. Discussion Many of the studies appraised for this review had moderate risks of bias. Methodology varied considerably between studies, notably the timeframe studied, dose of ginger used, and the characteristics of subjects recruited (e.g. healthy vs. patients with chronic diseases). Conclusion The evidence that ginger affects platelet aggregation and coagulation is equivocal and further study is needed to definitively address this question. PMID:26488162
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Cost-efficiency of knowledge creation: randomized controlled trials vs. observational studies.
Struck, Rafael; Baumgarten, Georg; Wittmann, Maria
2014-04-01
This article reviews traditional and current perspectives on randomized, controlled trials (RCTs) and observational studies relative to the economic implications for public healthcare stakeholders. It takes an average of 17 years to bring 14% of original research into clinical practice. Results from high-quality observational studies may complement limited RCTs in primary and secondary literature bases, and enhance the incorporation of sound evidence-based guidelines. Observational findings from comprehensive medical databases may offer valuable clues on the effectiveness and relevance of public healthcare interventions. Major expenditures associated with RCTs relate to recruitment, inappropriate site selection, conduct and reporting. Application of business strategies and economic evaluation tools, in addition to the planning and conduct of RCTs, may enhance clinical trial site performances. Considering the strengths and limitations of each study type, clinical researchers should explore the contextual worthiness of either design in promulgating knowledge. They should focus on quality of conduct and reporting that may allow for the liberation of limited public and private clinical research funding.
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The Cohen syndrome: clinical and endocrinological studies of two new cases.
Balestrazzi, P; Corrini, L; Villani, G; Bolla, M P; Casa, F; Bernasconi, S
1980-01-01
This report concerns two new cases of the Cohen syndrome and gives further information on the variable phenotypical pattern of the disease. The frequency of major and minor clinical signs is reviewed from all the published reports. Among the minor signs we found previously undescribed skeletal abnormalities in one of our patients. The reported delay onset of puberty, which appears to be a frequent aspect of the syndrome, seems to occur without LH and FSH deficiency, as our patients show. Images PMID:6782211
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The effect of the European Clinical Trials Directive on published drug research in anaesthesia.
Walker, E; Hankins, M C; White, S M
2009-09-01
The clinical indications for anaesthetic drugs are developed through peer-reviewed publication of clinical trials. We performed a bibliometric analysis of all human research papers reported in nine general anaesthesia journals over 6 years (n = 6489), to determine any effects of the 2004 European Clinical Trials Directive on reported drug research in anaesthesia originating from Europe and the United Kingdom. We found 89% studies involved patients and 11% volunteers. Of 3234 (50%) drug studies, 96% were phase IV (post-marketing) trials. Worldwide, the number of research papers fell by 3.6% (p < 0.004) in the 3 years following introduction of the European Clinical Trials Directive (5% Europe, 18% United Kingdom), and drug research papers fell by 12% (p < 0.001; 15% Europe, 29% United Kingdom). The introduction of the Clinical Trials Directive has therefore coincided with a decline in European drug research, particularly that originating from the United Kingdom. We suggest a number of measures researchers could take in response, and we propose a simplification of the application process for phase IV clinical trials, emphasising patient risk assessment.
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Adam, Gaelen P; Springs, Stacey; Trikalinos, Thomas; Williams, John W; Eaton, Jennifer L; Von Isenburg, Megan; Gierisch, Jennifer M; Wilson, Lisa M; Robinson, Karen A; Viswanathan, Meera; Middleton, Jennifer Cook; Forman-Hoffman, Valerie L; Berliner, Elise; Kaplan, Robert M
2018-04-16
We investigated whether information in ClinicalTrials.gov would impact the conclusions of five ongoing systematic reviews. We considered five reviews that included 495 studies total. Each review team conducted a search of ClinicalTrials.gov up to the date of the review's last literature search, screened the records using the review's eligibility criteria, extracted information, and assessed risk of bias and applicability. Each team then evaluated the impact of the evidence found in ClinicalTrials.gov on the conclusions in the review. Across the five reviews, the number of studies that had both a registry record and a publication varied widely, from none in one review to 43% of all studies identified in another. Among the studies with both a record and publication, there was also wide variability in the match between published outcomes and those listed in ClinicalTrials.gov. Of the 173 total ClinicalTrials.gov records identified across the five projects, between 11 and 43% did not have an associated publication. In the 14% of records that contained results, the new data provided in the ClinicalTrials.gov records did not change the results or conclusions of the reviews. Finally, a large number of published studies were not registered in ClinicalTrials.gov, but many of these were published before ClinicalTrials.gov's inception date of 2000. Improved prospective registration of trials and consistent reporting of results in ClinicalTrials.gov would help make ClinicalTrials.gov records more useful in finding unpublished information and identifying potential biases. In addition, consistent indexing in databases, such as MEDLINE, would allow for better matching of records and publications, leading to increased utility of these searches for systematic review projects.
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Faggion, Clovis Mariano; Aranda, Luisiana; Diaz, Karla Tatiana; Shih, Ming-Chieh; Tu, Yu-Kang; Alarcón, Marco Antonio
2016-01-01
Information on precision of treatment-effect estimates is pivotal for understanding research findings. In animal experiments, which provide important information for supporting clinical trials in implant dentistry, inaccurate information may lead to biased clinical trials. The aim of this methodological study was to determine whether sample size calculation, standard errors, and confidence intervals for treatment-effect estimates are reported accurately in publications describing animal experiments in implant dentistry. MEDLINE (via PubMed), Scopus, and SciELO databases were searched to identify reports involving animal experiments with dental implants published from September 2010 to March 2015. Data from publications were extracted into a standardized form with nine items related to precision of treatment estimates and experiment characteristics. Data selection and extraction were performed independently and in duplicate, with disagreements resolved by discussion-based consensus. The chi-square and Fisher exact tests were used to assess differences in reporting according to study sponsorship type and impact factor of the journal of publication. The sample comprised reports of 161 animal experiments. Sample size calculation was reported in five (2%) publications. P values and confidence intervals were reported in 152 (94%) and 13 (8%) of these publications, respectively. Standard errors were reported in 19 (12%) publications. Confidence intervals were better reported in publications describing industry-supported animal experiments (P = .03) and with a higher impact factor (P = .02). Information on precision of estimates is rarely reported in publications describing animal experiments in implant dentistry. This lack of information makes it difficult to evaluate whether the translation of animal research findings to clinical trials is adequate.
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Lumbar hernia in South Korea: different from that in foreign literature?
Park, S H; Chung, H S; Song, S H
2015-10-01
This study aimed to analyze the clinical features of lumbar hernia reported in South Korea and compare these features with those reported in foreign literature. From January 1968 through December 2013, 13 cases reported in South Korea were included in the study. The variables compared were age, sex, main symptoms at hospital visit, etiology, location, herniated contents, lateralization, defect size, diagnostic methods, surgical methods, surgical opinions, and recurrence. In the South Korean cases, women outnumbered men (3.3:1) and no significant differences were found in the herniated side (left:right, 1.1:1). In contrast, in the foreign cases, men outnumbered women (3:1) and left-sided hernia was dominant (2:1). Moreover, in most of the foreign cases, patients were aged 50-70 years, whereas in the South Korean cases, none of the patients were in their 50 s. However, no substantial differences were found in etiology, anatomical locations, symptoms, and herniated contents. This research revealed that few clinical features of lumbar hernias in South Korea differ from those reported in foreign literature. Thirteen cases were analyzed in the present study, and results obtained from such a small sample size cannot be generalized with certainty. Therefore, more cases should be collected for a definitive analysis. Despite this limitation, this study is important because it is the first attempt to collect and analyze the clinical features of lumbar hernia in South Korea. This study will serve as a basis for future studies investigating the clinical features of lumbar hernia cases in South Korea.
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Morey, Leslie C
2010-05-01
To identify doctoral programs with strong concentrations in clinical assessment, I measured productivity and impact of faculty at North American institutions with American Psychological Association accredited clinical programs. Publications, citations, and h-indexes derived from 4 top assessment journals were calculated over a 10-year period (1999-2009). I identified a total of 42 leading programs that collectively accounted for more than half of the publications and citations in these journals. I found a moderate relationship between assessment productivity and both US News & World Report program rankings as well as general productivity rankings of clinical programs reported in an earlier study.
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D'hondt, Norman E; Kiers, Henri; Pool, Jan J M; Hacquebord, Sijmen T; Terwee, Caroline B; Veeger, Dirkjan H E J
2017-01-01
Deviant shoulder girdle movement is suggested as an eminent factor in the etiology of shoulder pain. Reliable measurements of shoulder girdle kinematics are a prerequisite for optimizing clinical management strategies. The purpose of this study was to evaluate the reliability, measurement error, and internal consistency of measurements with performance-based clinical tests for shoulder girdle kinematics and positioning in patients with shoulder pain. The MEDLINE, Embase, CINAHL, and SPORTDiscus databases were systematically searched from inception to August 2015. Articles published in Dutch, English, or German were included if they involved the evaluation of at least one of the measurement properties of interest. Two reviewers independently evaluated the methodological quality per studied measurement property with the 4-point-rating scale of the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) checklist, extracted data, and assessed the adequacy of the measurement properties. Forty studies comprising more than 30 clinical tests were included. Actual reported measurements of the tests were categorized into: (1) positional measurement methods, (2) measurement methods to determine dynamic characteristics, and (3) tests to diagnose impairments of shoulder girdle function. Best evidence synthesis of the tests was performed per measurement for each measurement property. All studies had significant limitations, including incongruence between test description and actual reported measurements and a lack of reporting on minimal important change. In general, the methodological quality of the selected studies was fair to poor. High-quality evidence indicates that measurements obtained with the Modified Scapular Assistance Test are not reliable for clinical use. Sound recommendations for the use of other tests could not be made due to inadequate evidence. Across studies, diversity in description, performance, and interpretation of similar tests was present, and different criteria were used to establish similar diagnoses, mostly without taking into account a clinically meaningful context. Consequently, these tests lack face validity, which hampers their clinical use. Further research on validity and how to integrate a clinically meaningful context of movement into clinical tests is warranted. © 2017 American Physical Therapy Association
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Chong, A B; Taylor, M; Schubert, G; Vassar, M
2017-04-01
In recent years, clinical practice guidelines have been criticized for biased interpretations of research evidence, and interventional radiology is no exception. Our aim was to evaluate the methodologic quality and transparency of reporting in systematic reviews used as evidence in interventional radiology clinical practice guidelines for neurovascular disorders from the Society of Interventional Radiology. Our sources were 9 neurovascular disorder clinical practice guidelines from the Society of Interventional Radiology. We selected 65 systematic reviews and meta-analyses. A Measurement Tool to Assess Systematic Reviews (AMSTAR) and Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) tools were used to assess the methodologic quality and reporting transparency of systematic reviews. Radial plots were created on the basis of average scores for PRISMA and AMSTAR items. On the basis of AMSTAR scores, 3 (4.62%) reviews were high-quality, 28 reviews (43.08%) were moderate-quality, and 34 reviews (52.31%) were low-quality, with an average quality score of 3.66 (34.32%; minimum, 0%; maximum, 81.82%). The average PRISMA score was 18.18 (69.41%). We were unable to obtain previous versions for 8 reviews, 7 of which were from the Cochrane Database of Systematic Reviews. The methodologic quality of systematic reviews needs to be improved. Although reporting clarity was much better than the methodologic quality, it still has room for improvement. The methodologic quality and transparency of reporting did not vary much among clinical practice guidelines. This study can also be applied to other medical specialties to examine the quality of studies used as evidence in their own clinical practice guidelines. © 2017 by American Journal of Neuroradiology.
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Lee, Evelyn; Illingworth, Peter; Wilton, Leeanda; Chambers, Georgina Mary
2015-02-01
Is preimplantation genetic diagnosis for aneuploidy (PGD-A) with analysis of all chromosomes during assisted reproductive technology (ART) clinically and cost effective? The majority of published studies comparing a strategy of PGD-A with morphologically assessed embryos have reported a higher implantation rate per embryo using PGD-A, but insufficient data has been presented to evaluate the clinical and cost-effectiveness of PGD-A in the clinical setting. Aneuploidy is a leading cause of implantation failure, miscarriage and congenital abnormalities in humans, and a significant cause of ART failure. Preclinical evidence of PGD-A indicates that the selection and transfer of euploid embryos during ART should improve clinical outcomes. A systematic review of the literature was performed for full text English language articles using MEDLINE, EMBASE, SCOPUS, Cochrane Library databases, NHS Economic Evaluation Database and EconLit. The Downs and Black scoring checklist was used to assess the quality of studies. Clinical effectiveness was measured in terms of pregnancy, live birth and miscarriage rates. Nineteen articles meeting the inclusion criteria, comprising three RCTs in young and good prognosis patients and 16 observation studies were identified. Five of the observational studies included a control group of patients where embryos were selected based on morphological criteria (matched cohort studies). Of the five studies that included a control group and reported implantation rates, four studies (including two RCTs) demonstrated improved implantation rates in the PGD-A group. Of the eight studies that included a control group, six studies (including two RCTs) reported significantly higher pregnancy rates in the PGD-A group, and in the remaining two studies, equivalent pregnancies rates were reported despite fewer embryos being transferred in the PGD-A group. The three RCTs demonstrated benefit in young and good prognosis patients in terms of clinical pregnancy rates and the use of single embryo transfer. However, studies relating to patients of advanced maternal age, recurrent miscarriage and implantation failure were restricted to matched cohort studies, limiting the ability to draw meaningful conclusions. Relevant studies may have been missed and findings from RCTs currently being undertaken could not be included. Given the uncertain role of PGD-A techniques, high-quality experimental studies using intention-to-treat analysis and cumulative live birth rates including the comparative outcomes from remaining cryopreserved embryos are needed to evaluate the overall role of PGD-A in the clinical setting. It is only in this way that the true contribution of PGD-A to ART can be understood. © The Author 2014. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.
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Nabors, Christopher; Peterson, Stephen J; Aronow, Wilbert S; Sule, Sachin; Mumtaz, Arif; Shah, Tushar; Eskridge, Etta; Wold, Eric; Stallings, Gary W; Burak, Kathleen Kelly; Goldberg, Randy; Guo, Gary; Sekhri, Arunabh; Mathew, George; Khera, Sahil; Montoya, Jessica; Sharma, Mala; Paudel, Rajiv; Frishman, William H
2014-12-01
Reporting of clinically significant events represents an important mechanism by which patient safety problems may be identified and corrected. However, time pressure and cumbersome report entry procedures have discouraged the full participation of physicians. To improve the process, our internal medicine training program developed an easy-to-use mobile platform that combines the reporting process with patient sign-out. Between August 25, 2011, and January 25, 2012, our trainees entered clinically significant events into i-touch/i-phone/i-pad based devices functioning in wireless-synchrony with our desktop application. Events were collected into daily reports that were sent from the handoff system to program leaders and attending physicians to plan for rounds and to correct safety problems. Using the mobile module, residents entered 31 reportable events per month versus the 12 events per month that were reported via desktop during a previous 6-month study period. Advances in information technology now permit clinically significant events that take place during "off hours" to be identified and reported (via handoff) to next providers and to supervisors via collated reports. This information permits hospital leaders to correct safety issues quickly and effectively, while attending physicians are able to use information gleaned from the reports to optimize rounding plans and to provide additional oversight of trainee on call patient management decisions.
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Characteristics of dental clinics in US children's hospitals.
Ciesla, David; Kerins, Carolyn A; Seale, N Sue; Casamassimo, Paul S
2011-01-01
This study's purpose was to describe the workforce, patient, and service characteristics of dental clinics affiliated with US children's hospitals belonging to the National Association of Children's Hospital and Related Institutions (NACHRI). A 2-stage survey mechanism using ad hoc questionnaires sought responses from hospital administrators and dental clinic administrators. Questionnaires asked about: (1) clinic purpose; (2) workforce; (3) patient population; (4) dental services provided; (5) community professional relations; and (5) relationships with medical services. Of the 222 NACHRI-affiliated hospitals, 87 reported comprehensive dental clinics (CDCs) and 64 (74%) of CDCs provided data. Provision of tertiary medical services was significantly related to presence of a CDC. Most CDCs were clustered east of the Mississippi River. Size, workload, and patient characteristics were variable across CDCs. Most were not profitable. Medical diagnosis was the primary criterion for eligibility, with all but 1 clinic treating special needs children. Most clinics (74%) had dental residencies. Over 75% reported providing dental care prior to major medical care (cardiac, oncology, transplantation), but follow-up care was variable. Many children's hospitals reported comprehensive dental clinics, but the characteristics were highly variable, suggesting this element of the pediatric oral health care safety net may be fragile.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-02
... Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center... NIMH-sponsored clinical research studies that plan to enroll 150 or more human subjects in a single study. Clinical studies can have difficulty recruiting, and accurate and timely reporting is the best...
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Roll, Shawn C.; Asai, Christina; Tsai, Julieann
2015-01-01
Background Musculoskeletal sonography use in point-of-care physical medicine and rehabilitation is rapidly expanding, not only by physiatrists, but also by non-physician rehabilitation providers. Aim To evaluate the current range, extent and nature of literature and to identify emerging areas of evidence for the use of musculoskeletal sonography involving non-physician rehabilitation providers to guide research and clinical practice. Design Scoping Review Setting Inpatient, Outpatient, Other Population Musculoskeletal conditions Methods Five databases were searched and 578 unique abstracts were identified and screened for eligibility. Three raters independently read 68 full texts and 36 articles that reported on applied uses of sonography by non-physician rehabilitation providers were included. Results Eighteen studies described direct clinical use, primarily for outcomes measurement (n=12) or as a biofeedback intervention (n=10). Twelve laboratory studies were included that related morphology to patient reports or validated clinical interventions. Six additional studies, although not involving non-physician providers, were included as they presented potential valuable uses that were not noted in the other included studies, such as monitoring bone healing, tendon repair, and evaluation of idiopathic symptom reports or non-specific primary diagnoses. Conclusion This review indicates that non-physician rehabilitation providers use sonography for outcomes measurement and biofeedback interventions. Research is needed to evaluate effects of these uses on patient outcomes and to explore additional potential uses for clinical reasoning, treatment planning, and monitoring of tissue healing related to intervention. Clinical Rehabilitation Impact Implementation of musculoskeletal sonography by non-physician rehabilitation providers has the potential to be a critically advantageous addition to improve care. PMID:26201705
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Quah, C; Holmes, D; Khan, T; Cockshott, S; Lewis, J; Stephen, A
2018-01-01
Background All NHS-funded providers are required to collect and report patient-reported outcome measures for hip and knee arthroplasty. Although there are established guidelines for timing such measures following arthroplasty, there are no specific time-points for collection in the preoperative period. The primary aim of this study was to identify whether there was a significant amount of variability in the Oxford hip and knee scores prior to surgical intervention when completed in the outpatient clinic at the time of listing for arthroplasty or when completed at the preoperative assessment clinic. Methods A prospective cohort study of patients listed for primary hip or knee arthroplasty was conducted. Patients were asked to fill in a preoperative Oxford score in the outpatient clinic at the time of listing. They were then invited to fill in the official outcome measures questionnaire at the preoperative assessment clinic. The postoperative Oxford score was then completed when the patient was seen again at their postoperative follow up in clinic. Results Of the total of 109 patients included in this study period, there were 18 (17%) who had a worse score of 4 or more points difference and 43 (39.4%) who had an improvement of 4 or more points difference when the scores were compared between time of listing at the outpatient and at the preoperative assessment clinic. There was a statistically significant difference (P = 0.0054) in the mean Oxford scores. Conclusions The results of our study suggest that there should be standardisation of timing for completing the preoperative patient-reported outcome measures.
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Linking ClinicalTrials.gov and PubMed to Track Results of Interventional Human Clinical Trials
Huser, Vojtech; Cimino, James J.
2013-01-01
Objective In an effort to understand how results of human clinical trials are made public, we analyze a large set of clinical trials registered at ClinicalTrials.gov, the world’s largest clinical trial registry. Materials and Methods We considered two trial result artifacts: (1) existence of a trial result journal article that is formally linked to a registered trial or (2) the deposition of a trial’s basic summary results within the registry. Results The study sample consisted of 8907 completed, interventional, phase 2-or-higher clinical trials that were completed in 2006-2009. The majority of trials (72.2%) had no structured trial-article link present. A total of 2367 trials (26.6%) deposited basic summary results within the registry. Of those , 969 trials (10.9%) were classified as trials with extended results and 1398 trials (15.7%) were classified as trials with only required basic results. The majority of the trials (54.8%) had no evidence of results, based on either linked result articles or basic summary results (silent trials), while a minimal number (9.2%) report results through both registry deposition and publication. Discussion Our study analyzes the body of linked knowledge around clinical trials (which we refer to as the “trialome”). Our results show that most trials do not report results and, for those that do, there is minimal overlap in the types of reporting. We identify several mechanisms by which the linkages between trials and their published results can be increased. Conclusion Our study shows that even when combining publications and registry results, and despite availability of several information channels, trial sponsors do not sufficiently meet the mandate to inform the public either via a linked result publication or basic results submission. PMID:23874614
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Berlin, Nicholas L; Momoh, Adeyiza O; Qi, Ji; Hamill, Jennifer B; Kim, Hyungjin M; Pusic, Andrea L; Wilkins, Edwin G
2017-08-01
Existing studies evaluating racial and ethnic disparities focus on describing differences in procedure type and the proportion of women who undergo reconstruction following mastectomy. This study seeks to examine racial and ethnic variations in clinical and patient-reported outcomes (PROs) following breast reconstruction. The Mastectomy Reconstruction Outcomes Consortium is an 11 center, prospective cohort study collecting clinical and PROs following autologous and implant-based breast reconstruction. Mixed-effects regression models, weighted to adjust for non-response, were performed to evaluate outcomes at one-year postoperatively. The cohort included 2703 women who underwent breast reconstruction. In multivariable models, Hispanic or Latina patients were less likely to experience any complications and major complications. Black or African-American women reported greater improvements in psychosocial and sexual well-being. Despite differences in pertinent clinical and socioeconomic variables, racial and ethnic minorities experienced equivalent or better outcomes. These findings provide reassurance in the context of numerous racial and ethnic health disparities and build upon our understanding of the delivery of surgical care to women with or at risk for developing breast cancer. Copyright © 2017 Elsevier Inc. All rights reserved.
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Perception matters for clinical perfectionism and social anxiety.
Levinson, Cheri A; Rodebaugh, Thomas L; Shumaker, Erik A; Menatti, Andrew R; Weeks, Justin W; White, Emily K; Heimberg, Richard G; Warren, Cortney S; Blanco, Carlos; Schneier, Franklin; Liebowitz, Michael R
2015-01-01
Despite research documenting a relationship between social anxiety and perfectionism, very little research has examined the relationship between social anxiety and clinical perfectionism, defined as the combination of high personal standards and high maladaptive perfectionistic evaluative concern. In the current studies we examined whether clinical perfectionism predicted social anxiety in a large sample of undergraduates (N=602), in a clinical sample of participants diagnosed with social anxiety disorder (SAD; N=180), and by using a variance decomposition model of self- and informant-report of perfectionism (N=134). Using self-report, we found that an interaction of personal standards and evaluative concern predicted both social interaction anxiety and fear of scrutiny, but not in the theorized direction. Specifically, we found that self-report of low standards and high evaluative concern was associated with the highest levels of social anxiety, suggesting that when individuals with SAD hold low expectations for themselves combined with high concerns about evaluation, social anxiety symptoms may increase. Alternatively, when an informants' perspective was considered, and more consistent with the original theory, we found that the interaction of informant-only report of personal standards and shared-report (between both primary participant and informant) of concern over mistakes was associated with self-reported social anxiety, such that high concern over mistakes and high personal standards predicted the highest levels of social anxiety. Theoretical, clinical, and measurement implications for clinical perfectionism are discussed. Copyright © 2014 Elsevier Ltd. All rights reserved.
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Skin acceptability of a cosmetic moisturizer formulation in female subjects with sensitive skin.
Nisbet, Stephanie J
2018-01-01
This 3-week, open-label, noncomparative clinical study evaluated the skin acceptability of a cosmetic moisturizer in subjects with sensitive skin, by monitoring adverse events (AEs) and cutaneous discomfort related to normal usage. Female subjects aged between 18-60 years, with Fitzpatrick phototype classification I-IV and sensitive skin, verified by a positive reaction on the stinging test at screening, were included. Subjects applied the moisturizer to their face and body twice daily for 21±2 days at home and recorded study product usage and feelings of cutaneous discomfort (eg, dryness, prickling, stinging, and itching) in a diary; any AEs were reported to the clinic. At study end, skin acceptability of the moisturizer was investigator-assessed based on the nature of AEs and subjects' self-reported feelings of discomfort, and by clinical evaluation of skin reactions in the area of moisturizer application (appearance of erythema, formation of edema, and skin desquamation; scored according to an adapted Draize and Kligman scale). Only subjects with a treatment compliance of ≥80% were included in the final analysis. In total, 35 subjects initiated and completed the study; all were compliant to the minimum study product usage. Per investigator clinical dermatological assessment at study end, none of the 35 subjects had skin reactions in the area of moisturizer application and there were no reported AEs. One subject reported sensations of mild prickling and itching immediately after applying the moisturizer (not classified as AEs), which spontaneously remitted after complete absorption of the product and were noted only in exposed areas. These events were considered by the investigator as being possibly/probably related to the use of study product; however, no clinical signs of skin reaction were observed in the exposed areas. This cosmetic moisturizer appears generally well tolerated and suitable for topical use in subjects with sensitive skin.
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Skin acceptability of a cosmetic moisturizer formulation in female subjects with sensitive skin
Nisbet, Stephanie J
2018-01-01
Purpose This 3-week, open-label, noncomparative clinical study evaluated the skin acceptability of a cosmetic moisturizer in subjects with sensitive skin, by monitoring adverse events (AEs) and cutaneous discomfort related to normal usage. Materials and methods Female subjects aged between 18–60 years, with Fitzpatrick phototype classification I–IV and sensitive skin, verified by a positive reaction on the stinging test at screening, were included. Subjects applied the moisturizer to their face and body twice daily for 21±2 days at home and recorded study product usage and feelings of cutaneous discomfort (eg, dryness, prickling, stinging, and itching) in a diary; any AEs were reported to the clinic. At study end, skin acceptability of the moisturizer was investigator-assessed based on the nature of AEs and subjects’ self-reported feelings of discomfort, and by clinical evaluation of skin reactions in the area of moisturizer application (appearance of erythema, formation of edema, and skin desquamation; scored according to an adapted Draize and Kligman scale). Only subjects with a treatment compliance of ≥80% were included in the final analysis. Results In total, 35 subjects initiated and completed the study; all were compliant to the minimum study product usage. Per investigator clinical dermatological assessment at study end, none of the 35 subjects had skin reactions in the area of moisturizer application and there were no reported AEs. One subject reported sensations of mild prickling and itching immediately after applying the moisturizer (not classified as AEs), which spontaneously remitted after complete absorption of the product and were noted only in exposed areas. These events were considered by the investigator as being possibly/probably related to the use of study product; however, no clinical signs of skin reaction were observed in the exposed areas. Conclusion This cosmetic moisturizer appears generally well tolerated and suitable for topical use in subjects with sensitive skin. PMID:29750047
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Newcastle Disease Virus (PDQ®)—Health Professional Version
Newcastle disease virus (NDV)- based therapy has been reported to be of benefit in clinical studies, but results are considered inconclusive. Study designs were weak and the study reports were generally incomplete. Get detailed information about NDV use in cancer in this summary for clinicians.
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Evaluation of extemporaneous oral itraconazole suspensions by dissolution profiles mapping.
Tong, Henry H Y; Chan, Hokman; Du, Zhen; Zheng, Ying
2010-01-01
The objective of this study was to evaluate by dissolution profiles mapping five extemporaneous oral itraconazole suspensions reported in the literature. Dissolution profiles of the extemporaneous oral itraconazole preparations were mapped and correlated with their reported clinical data therein. Four out of five extemporaneous preparations had either too early or insufficient release of itraconazole during the dissolution study, potentially limiting the in vivo oral bioavailability in patients. Dissolution profiles in the remaining extemporaneous preparation was closely similar to that in commercial itraconazole capsules. Based on the reported clinical data and dissolution results in this study, the extemporaneous preparation proposed in a study by Ong and Fobes seems to be the most reasonable choice for our patients. Dissolution profile evaluation is an important quality-control parameter during the evaluation of extemporaneous preparations by pharmacists.
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NASPGHAN Capsule Endoscopy Clinical Report.
Friedlander, Joel A; Liu, Quin Y; Sahn, Benjamin; Kooros, Koorosh; Walsh, Catharine M; Kramer, Robert E; Lightdale, Jenifer R; Khlevner, Julie; McOmber, Mark; Kurowski, Jacob; Giefer, Matthew J; Pall, Harpreet; Troendle, David M; Utterson, Elizabeth C; Brill, Herbert; Zacur, George M; Lirio, Richard A; Lerner, Diana G; Reynolds, Carrie; Gibbons, Troy E; Wilsey, Michael; Liacouras, Chris A; Fishman, Douglas S
2017-03-01
Wireless capsule endoscopy (CE) was introduced in 2000 as a less invasive method to visualize the distal small bowel in adults. Because this technology has advanced it has been adapted for use in pediatric gastroenterology. Several studies have described its clinical use, utility, and various training methods but pediatric literature regarding CE is limited. This clinical report developed by the Endoscopic and Procedures Committee of the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition outlines the current literature, and describes the recommended current role, use, training, and future areas of research for CE in pediatrics.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Beck, R.N.; Cooper, M.D.
1984-09-01
This report presents progress in the areas of cardiac nuclear medicine, other imaging studies, investigations with biomolecules, and assessment of risks associated with the clinical use of radiopharmaceuticals. (ACR)
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Clinical Utility of the CCAPS, CAS, and OQ-45
ERIC Educational Resources Information Center
MacFarlane, Ian M.; Henry, Courtney L.; Nash, Trisha; Kissel, Susan; Bush, David
2015-01-01
This article reports on a study evaluating the clinical utility of three clinical assessment measures commonly used in university counseling centers: the Outcome Questionnaire-45 (OQ-45), the Counseling Center Assessment of Psychological Symptoms, and the College Adjustment Scales. Results found subscales assessing depression and anxiety were…
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Skin problems of the stump in lower limb amputees: 1. A clinical study.
Meulenbelt, Henk E J; Geertzen, Jan H B; Jonkman, Marcel F; Dijkstra, Pieter U
2011-03-01
Use of a prosthesis in lower limb amputees can lead to skin problems of the amputation stump. However, little is known about the epidemiology and type of problems experienced. We conducted a cross-sectional survey consisting of a questionnaire and a clinical assessment of the amputation stump. The aims of the study were to estimate the prevalence of skin problems of the amputation stump, to evaluate the impact of these skin problems and to evaluate differences between clinically observed skin problems and skin problems reported by the amputee. Participants (n = 124) were recruited from among lower limb amputees who visited an orthopaedic workshop. The prevalence of skin problems was 36%. Problems identified were: reduction in prosthesis use, and reduction in walking distance without a break. Significantly more skin problems were reported than observed (p = 0.011). Cold skin and excessive perspiration in particular were significantly more reported than observed.
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Therapeutic Potential of Enoxaparin in Lichen Planus: Exploring Reasons for Inconsistent Reports
Patel, Rahul P.; Shastri, Madhur D.; Ming, Long Chiau; Zaidi, Syed Tabish R.; Peterson, Gregory M.
2018-01-01
Lichen planus (LP) is an uncommon mucocutaneous inflammatory condition, that is immunologically mediated, typically pruritic and often recurs. The currently advocated therapies are either not highly effective or associated with severe side effects. Enoxaparin, a widely used anticoagulant, is composed of both anticoagulant and non-anticoagulant fragments. Enoxaparin is reported to have anti-inflammatory properties and it was found to be effective in LP. However, the results from clinical studies have varied substantially and, therefore, the clinical role of enoxaparin in LP remains uncertain. This review focuses on potential reasons for the reported inconsistent outcomes, as well as proposing solutions; these include identifying batch-to-batch inconsistency in the composition of enoxaparin. The potential therapeutic value of enoxaparin in LP must be explored using well-designed clinical trials, combined with experimental studies that focus on identifying the anti-inflammatory fragments of enoxaparin and elucidating the mechanism of action of these non-anticoagulant fragments.
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Bamba, S; Barro-Traoré, F; Drabo, M K; Gouba, A; Traoré, A; Guiguemdé, T R
2013-01-01
It is a retrospective study in the Service of Dermatology at the University Hospital Center Yalgado Ouédraogo of Ouagadougou (C.H.U.-YO). This study aimed to list the leishmaniasis clinical cases reported in the registers of this department from January 1999 to December 2007. In total, 251 leishmaniasis clinical cases have been reported. The hospital prevalence was 1,1%. Women represented 53% versus 47% men. The average age of patients was 22,78 ans +/- 121. The most frequent clinical forms were those often crusted (40.2%), papulo ulcerative (16.7%) and papulonodular (13.9%). Lesions most often sat on the lower limbs (33%) and thoracic limbs (45%). On the therapeutic level, the first line treatment meglumine antimonite (Glucantime) accounted for only 25.9% of prescriptions.
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Pinto, Ana Cecília Versiani Duarte; Andrade, Tatiana Cristina Pedro Cordeiro de; Brito, Fernanda Freitas de; Silva, Gardênia Viana da; Cavalcante, Maria Lopes Lamenha Lins; Martelli, Antonio Carlos Ceribelli
2017-01-01
Trichotillomania is a psychodermatologic disorder characterized by uncontrollable urge to pull one's own hair. Differential diagnoses include the most common forms of alopecia such as alopecia areata. It is usually associated with depression and obsessive-compulsive disorder. Trichotillomania treatment standardization is a gap in the medical literature. Recent studies demonstrated the efficacy of N-acetylcysteine (a glutamate modulator) for the treatment of the disease. We report the clinical case of a 12-year-old female patient who received the initial diagnosis of alopecia areata, but presented with clinical and dermoscopic features of trichotillomania. She was treated with the combination of psychotropic drugs and N-acetylcysteine with good clinical response. Due to the chronic and recurring nature of trichotillomania, more studies need to be conducted for the establishment of a formal treatment algorithm.
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Pinto, Ana Cecília Versiani Duarte; de Andrade, Tatiana Cristina Pedro Cordeiro; de Brito, Fernanda Freitas; da Silva, Gardênia Viana; Cavalcante, Maria Lopes Lamenha Lins; Martelli, Antonio Carlos Ceribelli
2017-01-01
Trichotillomania is a psychodermatologic disorder characterized by uncontrollable urge to pull one's own hair. Differential diagnoses include the most common forms of alopecia such as alopecia areata. It is usually associated with depression and obsessive-compulsive disorder. Trichotillomania treatment standardization is a gap in the medical literature. Recent studies demonstrated the efficacy of N-acetylcysteine (a glutamate modulator) for the treatment of the disease. We report the clinical case of a 12-year-old female patient who received the initial diagnosis of alopecia areata, but presented with clinical and dermoscopic features of trichotillomania. She was treated with the combination of psychotropic drugs and N-acetylcysteine with good clinical response. Due to the chronic and recurring nature of trichotillomania, more studies need to be conducted for the establishment of a formal treatment algorithm. PMID:28225970
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Supporting Clinical Practice Candidates in Learning Community Development
ERIC Educational Resources Information Center
DeJarnette, Nancy K.; Sudeck, Maria
2015-01-01
The purpose of this qualitative research study was to monitor pre-service teacher candidates' progression and implementation of the learning community philosophy along with classroom management strategies. The study took place during their final semester of clinical practice. Data were collected from self-reports, surveys, university supervisor…
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Current Clinical Interventions for Smoking Cessation: A Review of Empirical Studies.
ERIC Educational Resources Information Center
Marcellino, Robert Leonard, Jr.
This document reviews all empirical studies on clinically-based smoking cessation interventions that were reported in "Psychological Abstracts" between January 1982 and March 1990. Interventions are categorized as either physiological or psychological in orientation and are further grouped according to specific treatment type:…
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Challenges in Patient Recruitment, Implementation, and Fidelity in a Mobile Telehealth Study.
Baron, Justine; Hirani, Shashivadan; Newman, Stanton
2016-05-01
Mobile telehealth (MTH) evaluations in diabetes have been conducted, but few report details and issues related to recruitment, implementation (intervention delivery), fidelity, and context. These have important implications on the interpretation of the findings and effectiveness of the intervention. This article reports these data from an MTH study and describes the challenges experienced in running an intervention such as this in an active clinical environment. We conducted a mixed-methods MTH study that included a 9-month randomized controlled trial in people with poorly controlled diabetes. Detailed recruitment data were recorded during the study. Data on contacts between MTH participants and the MTH team were collected and used to report on intervention delivery and fidelity. Meeting and field notes, as well as communications between research team members during the study, were used to report on the contextual factors that affected recruitment, implementation, and fidelity. The recruited sample size represented 6% of the total clinic population (n = 1,360) and 10.7% of the number of potentially eligible people at the clinic (n = 802) identified at the beginning of the study. Contextual factors related to patients, healthcare providers, the institution, or the recruitment protocol contributed to influence access to study participants and the number of participants randomized (n = 81). Technical and device-related aspects of the MTH intervention were delivered successfully, but the expected education and clinical feedback by the MTH nurse were not delivered according to the protocol. Although 92.5% of introductory calls were made by the MTH nurses, only 13.3% of expected educational calls were performed. Changes to the MTH nursing staff affected intervention participants differently and contributed to the low fidelity of intervention delivery. The current article presents data on the influence of contextual factors on the conduct of this MTH study and underlines the need for these processes to be assessed and reported adequately in future MTH research.
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Nogueira, M L; Nery Júnior, N R R; Estofolete, C F; Bernardes Terzian, A C; Guimarães, G F; Zini, N; Alves da Silva, R; Dutra Silva, G C; Junqueira Franco, L C; Rahal, P; Bittar, C; Carneiro, B; Vasconcelos, P F C; Freitas Henriques, D; Barbosa, D M U; Lopes Rombola, P; de Grande, L; Negri Reis, A F; Palomares, S A; Wakai Catelan, M; Cruz, L E A A; Necchi, S H; Mendonça, R C V; Penha Dos Santos, I N; Alavarse Caron, S B; Costa, F; Bozza, F A; Soares de Souza, A; Brandão de Mattos, C C; de Mattos, L C; Vasilakis, N; Oliani, A H; Vaz Oliani, D C M; Ko, A I
2018-06-01
We aimed to report the first 54 cases of pregnant women infected by Zika virus (ZIKV) and their virologic and clinical outcomes, as well as their newborns' outcomes, in 2016, after the emergence of ZIKV in dengue-endemic areas of São Paulo, Brazil. This descriptive study was performed from February to October 2016 on 54 quantitative real-time PCR ZIKV-positive pregnant women identified by the public health authority of São José do Rio Preto, São Paulo, Brazil. The women were followed and had clinical and epidemiologic data collected before and after birth. Adverse outcomes in newborns were analysed and reported. Urine or blood samples from newborns were collected to identify ZIKV infection by reverse transcription PCR (RT-PCR). A total of 216 acute Zika-suspected pregnant women were identified, and 54 had the diagnosis confirmed by RT-PCR. None of the 54 women miscarried. Among the 54 newborns, 15 exhibited adverse outcomes at birth. The highest number of ZIKV infections occurred during the second and third trimesters. No cases of microcephaly were reported, though a broad clinical spectrum of outcomes, including lenticulostriate vasculopathy, subependymal cysts, and auditory and ophthalmologic disorders, were identified. ZIKV RNA was detected in 18 of 51 newborns tested and in eight of 15 newborns with adverse outcomes. Although other studies have associated many newborn outcomes to ZIKV infection during pregnancy, these same adverse outcomes were rare or nonexistent in this study. The clinical presentation the newborns we studied was mild compared to other reports, suggesting that there is significant heterogeneity in congenital Zika infection. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
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Onakpoya, Igho J; Heneghan, Carl J
2017-05-01
Certain nutritional supplements are being marketed for the management of Alzheimer's disease (AD), but the evidence for their effectiveness is not established. The objective of this review was to evaluate the evidence from randomized clinical trial (RCTs) examining the effect of Souvenaid in patients with AD. We conducted electronic searches in Medline, Embase, PsychINFO, CINAHL, and The Cochrane Library. The reporting quality of the included studies was determined using the Cochrane collaboration tool for assessing the risk of bias. Two reviewers independently determined eligibility, assessed the reporting quality of included studies and extracted data. Three studies with a total of 1011 participants were included. All were of good reporting quality. Meta-analyses revealed non-significant differences in cognition (ADAS-cog scores MD: 0.08, 95% CI: -0.71 to 0.88) and function (ADCS-ADL scores MD: 0.36, 95% CI: -0.54 to 1.25) between Souvenaid and placebo. One study showed significant increase in neuropsychological test battery composite z-score with Souvenaid compared with placebo, and another reported significant improvement in delayed verbal recall for a subgroup of patients with very mild AD. There was no significant effect on global clinical function. No serious adverse events were observed. The evidence from published clinical trials does not show that supplementation with Souvenaid has beneficial effects on functional ability, behaviour, or global clinical change. Souvenaid may cause improvements in verbal recall in patients at early stages of AD. Few RCTs examining the effect of Souvenaid have been conducted, and they are all funded by same manufacturer. Future research should include using unified tools to measure cognition, function, and behaviour in AD.
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Page, Tamara; Lockwood, Craig; Conroy-Hiller, Tiffany
2005-02-01
Background Coronary heart disease is the major cause of illness and death in Western countries and this is likely to increase as the average age of the population rises. Consumers with established coronary heart disease are at the highest risk of experiencing further coronary events. Lifestyle measures can contribute significantly to a reduction in cardiovascular mortality in established coronary heart disease. Improved management of cardiac risk factors by providing education and referrals as required has been suggested as one way of maintaining quality care in patients with established coronary heart disease. There is a need to ascertain whether or not nurse-led clinics would be an effective adjunct for patients with coronary heart disease to supplement general practitioner advice and care. Objectives The objective of this review was to present the best available evidence related to nurse-led cardiac clinics. Inclusion criteria This review considered any randomised controlled trials that evaluated cardiac nurse-led clinics. In the absence of randomised controlled trials, other research designs such as non-randomised controlled trials and before and after studies were considered for inclusion. Participants were adults (18 years and older) with new or existing coronary heart disease. The interventions of interest to the review included education, assessment, consultation, referral and administrative structures. Outcomes measured included adverse event rates, readmissions, admissions, clinical and cost effectiveness, consumer satisfaction and compliance with therapy. Results Based on the search terms used, 80 papers were initially identified and reviewed for inclusion; full reports of 24 of these papers were retrieved. There were no papers included that addressed cost effectiveness or adverse events; and none addressed the outcome of referrals. A critical appraisal of the 24 remaining papers identified a total of six randomised controlled trials that met the inclusion criteria. Two studies addressed nurse-led clinics for patients diagnosed with angina, one looked at medication administration and the other looked at educational plans. A further four studies compared secondary preventative care with a nurse-led clinic and general practitioner clinic. One specifically compared usual care versus shared care introduced by nurses for patients awaiting coronary artery bypass grafting. Of the remaining three studies, two have been combined in the results section, as they are an interim report and a final report of the same study. Because of inconsistencies in reporting styles and outcome measurements, meta-analysis could not be performed on all outcomes. However, a narrative summary of each study and comparisons of specific outcomes assessed from within each study has been developed. Although not all outcomes obtained statistical significance, nurse-led clinics were at least as effective as general practitioner clinics for most outcomes. Recommendations The following recommendations are made: • The use of nurse-led clinics is recommended for patients with coronary heart disease (Level II). • Utilise nurse-led clinics to increase clinic attendance and follow-up rates (Level II). • Nurse-led clinics are recommended for patients who require lifestyle changes to decrease their risk of adverse outcomes associated with coronary heart disease (Level II).
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Barthel, D; Fischer, K I; Nolte, S; Otto, C; Meyrose, A-K; Reisinger, S; Dabs, M; Thyen, U; Klein, M; Muehlan, H; Ankermann, T; Walter, O; Rose, M; Ravens-Sieberer, U
2016-03-01
To describe the implementation process of a computer-adaptive test (CAT) for measuring health-related quality of life (HRQoL) of children and adolescents in two pediatric clinics in Germany. The study focuses on the feasibility and user experience with the Kids-CAT, particularly the patients' experience with the tool and the pediatricians' experience with the Kids-CAT Report. The Kids-CAT was completed by 312 children and adolescents with asthma, diabetes or rheumatoid arthritis. The test was applied during four clinical visits over a 1-year period. A feedback report with the test results was made available to the pediatricians. To assess both feasibility and acceptability, a multimethod research design was used. To assess the patients' experience with the tool, the children and adolescents completed a questionnaire. To assess the clinicians' experience, two focus groups were conducted with eight pediatricians. The children and adolescents indicated that the Kids-CAT was easy to complete. All pediatricians reported that the Kids-CAT was straightforward and easy to understand and integrate into clinical practice; they also expressed that routine implementation of the tool would be desirable and that the report was a valuable source of information, facilitating the assessment of self-reported HRQoL of their patients. The Kids-CAT was considered an efficient and valuable tool for assessing HRQoL in children and adolescents. The Kids-CAT Report promises to be a useful adjunct to standard clinical care with the potential to improve patient-physician communication, enabling pediatricians to evaluate and monitor their young patients' self-reported HRQoL.
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ERIC Educational Resources Information Center
Norris, Susan L.; Holmer, Haley K.; Fu, Rongwei; Ogden, Lauren A.; Viswanathan, Meera S.; Abou-Setta, Ahmed M.
2014-01-01
Objective: This study aimed to examine selective outcome reporting (SOR) and selective analysis reporting (SAR) in randomized controlled trials (RCTs) and to explore the usefulness of trial registries for identifying SOR and SAR. Study Design and Setting: We selected one "index outcome" for each of three comparative effectiveness reviews…
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ERIC Educational Resources Information Center
Rutherford, Marion; McKenzie, Karen; Johnson, Tess; Catchpole, Ciara; O'Hare, Anne; McClure, Iain; Forsyth, Kirsty; McCartney, Deborah; Murray, Aja
2016-01-01
This article reports on gender ratio, age of diagnosis and the duration of assessment procedures in autism spectrum disorder diagnosis in a national study which included all types of clinical services for children and adults. Findings are reported from a retrospective case note analysis undertaken with a representative sample of 150 Scottish…
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ERIC Educational Resources Information Center
Muris, Peter; van der Pennen, Els; Sigmond, Rianne; Mayer, Birgit
2008-01-01
This study investigated the relation between the regulative trait of effortful control, and in particular attention control, and psychopathological symptoms in a sample of 207 non-clinical children aged 8-12 years. For this purpose, children completed self-report scales for measuring regulative traits and various types of psychopathological…
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Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review
Langrand-Escure, Julien; Rivoirard, Romain; Oriol, Mathieu; Tinquaut, Fabien; Rancoule, Chloé; Chauvin, Frank; Magné, Nicolas; Bourmaud, Aurélie
2017-01-01
Background Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. Data sources A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010–2015). Study eligibility criteria All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer. Intervention Quality of reporting was assessed using the Key Methodological Score. Results 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001). Limitations Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. Conclusions & implications of key findings This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials, reporting being incomplete in the corresponding articles. PMID:29216190
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Leidl, Reiner; Schweikert, Bernd; Hahmann, Harry; Steinacker, Juergen M; Reitmeir, Peter
2016-03-22
Quality of life as an endpoint in a clinical study may be sensitive to the value set used to derive a single score. Focusing on patients' actual valuations in a clinical study, we compare different value sets for the EQ-5D-3L and assess how well they reproduce patients' reported results. A clinical study comparing inpatient (n = 98) and outpatient (n = 47) rehabilitation of patients after an acute coronary event is re-analyzed. Value sets include: 1. Given health states and time-trade-off valuation (GHS-TTO) rendering economic utilities; 2. Experienced health states and valuation by visual analog scale (EHS-VAS). Valuations are compared with patient-reported VAS rating. Accuracy is assessed by mean absolute error (MAE) and by Pearson's correlation ρ. External validity is tested by correlation with established MacNew global scores. Drivers of differences between value sets and VAS are analyzed using repeated measures regression. EHS-VAS had smaller MAEs and higher ρ in all patients and in the inpatient group, and correlated best with MacNew global score. Quality-adjusted survival was more accurately reflected by EHS-VAS. Younger, better educated patients reported lower VAS at admission than the EHS-based value set. EHS-based estimates were mostly able to reproduce patient-reported valuation. Economic utility measurement is conceptually different, produced results less strongly related to patients' reports, and resulted in about 20 % longer quality-adjusted survival. Decision makers should take into account the impact of choosing value sets on effectiveness results. For transferring the results of heart rehabilitation patients from another country or from another valuation method, the EHS-based value set offers a promising estimation option for those decision makers who prioritize patient-reported valuation. Yet, EHS-based estimates may not fully reflect patient-reported VAS in all situations.
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Use of Benzodiazepines in Alzheimer’s Disease: A Systematic Review of Literature
Defrancesco, Michaela; Marksteiner, Josef; Fleischhacker, W. Wolfgang; Blasko, Imrich
2015-01-01
Background: Benzodiazepines are frequently prescribed in patients with Alzheimer’s disease. Unfortunately, studies evaluating their benefits and risks in these patients are limited. Methods: Clinical trials focusing on the effect of benzodiazepines on cognitive functions, disease progression, behavioral symptoms, sleep disturbances, and the general frequency of benzodiazepine use were included in this review. Published articles from January 1983 to January 2015 were identified using specific search terms in MEDLINE and PubMed Library according to the recommendations of The Strengthening the Reporting of Observational Studies in Epidemiology initiative. Results: Of the 657 articles found, 18 articles met predefined selection criteria and were included in this review (8 on frequency, 5 on cognitive functions, 5 on behavioral and sleep disturbances). The frequency of benzodiazepine use ranged from 8.5% to 20%. Five studies reported accelerated cognitive deterioration in association with benzodiazepine use. Two studies reported clinical efficacy for lorazepam and alprazolam to reduce agitation in Alzheimer’s disease patients. No evidence was found for an improvement of sleep quality using benzodiazepines. Conclusion: This systematic review shows a relatively high prevalence of benzodiazepine use but limited evidence for clinical efficacy in Alzheimer’s disease patients. However, there is a paucity of methodologically high quality controlled clinical trials. Our results underscore a need for randomized controlled trials in this area. PMID:25991652
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Tonetti, Maurizio; Palmer, Richard
2012-02-01
The objective of this working group was to assess and make specific recommendations to improve the quality of reporting of clinical research in implant dentistry and discuss ways to reach a consensus on choice of outcomes. Discussions were informed by three systematic reviews on quality of reporting of observational studies (case series, case-control and cohort) and experimental research (randomized clinical trials). An additional systematic review provided information on choice of outcomes and analytical methods. In addition, an open survey among all workshop participants was utilized to capture a consensus view on the limits of currently used survival and success-based outcomes as well as to identify domains that need to be captured by future outcome systems. The Workshop attempted to clarify the characteristics and the value in dental implant research of different study designs. In most areas, measurable quality improvements over time were identified. The Workshop recognized important aspects that require continued attention by clinical researchers, funding agencies and peer reviewers to decrease potential bias. With regard to choice of outcomes, the limitations of currently used systems were recognized. Three broad outcome domains that need to be captured by future research were identified: (i) patient reported outcome measures, (ii) peri-implant tissue health and (iii) performance of implant supported restorations. Peri-implant tissue health can be measured by marginal bone level changes and soft tissue inflammation and can be incorporated in time to event analyses. The Workshop recommended that collaboration between clinicians and epidemiologists/clinical trials specialists should be encouraged. Aspects of design aimed at limitation of potential bias should receive attention by clinical researchers, funding agencies and journal editors. Adherence to appropriate reporting guidelines such as STROBE and CONSORT are necessary standards. Research on outcome measure domains is an area of top priority and should urgently inform a proper process leading to a consensus on outcome measures in dental implant research. © 2012 John Wiley & Sons A/S.
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Narasethkamol, Arunchai; Charuluxananan, Somrat; Kyokong, Oranuch; Premsamran, Porntep; Kundej, Sarawut
2011-01-01
As a site of the Thai Anesthesia Incidents Monitoring Study (Thai AIMS), the authors continued data collection of incident reports to find out the frequency, clinical course, contributing factors, factors minimizing adverse events, and investigation of model appropriate for possible corrective strategies in a Thai university hospital. A standardized anesthesia incident report form that included close-end and open-end questions was provided to the attending anesthesia personnel of King Chulalongkorn Memorial Hospital between January I and December 31, 2007. They filled it on a voluntary and anonymous basis. Each incident report was reviewed by three reviewers. Any disagreement was discussed to achieve a consensus. One hundred sixty three incident reports were filled reporting 191 incidents. There were fewer male (44%) than female (56%) patients and they had an ASA physical status classification 1 (41%), 2 (43%), 3 (10%), 4 (4%) and 5 (2%). Surgical specialties that posed high risk of incidents were general, orthopedic, gynecological, otorhino-laryngological and urological surgery. Locations of incident were operating room (85%), ward (8%) and recovery room (2%). The common adverse incidents were oxygen desaturation (23%), arrhythmia needing treatment (14%), equipment malfunction (13%), drug error (9%), difficult intubation (6%), esophageal intubation (5%), cardiac arrest (5%), reintubation (4%), and endobronchial intubation (4%). Adverse events were detected by monitoring only (27%), by monitoring before clinical diagnosis (26%), by clinical diagnosis before monitoring (21%), and by clinical diagnosis only (26%). Incidents were considered to be from anesthesia related factor (73%), system factor (16%) and preventable (47%). Common factors related to incident were inexperience, lack of vigilance, haste, inappropriate decision, not comply with guidelines, and lack of equipment maintenance. Suggested corrective strategies were quality assurance activity, additional training, clinical practice guidelines, equipment maintenance, and improvement of supervision.
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Characteristics of antimicrobial studies registered in the USA through ClinicalTrials.Gov
Stockmann, Chris; Sherwin, Catherine M.T.; Ampofo, Krow; Hersh, Adam L.; Pavia, Andrew T.; Byington, Carrie L.; Ward, Robert M.; Spigarelli, Michael G.
2013-01-01
Increasing rates of antimicrobial-resistant infections and the dwindling pipeline of new agents necessitate judicious, evidence-based antimicrobial prescribing. Clinical trials represent a vital resource for establishing evidence of safety and efficacy, which are crucial to guiding antimicrobial treatment decisions. The objective of this study was to comprehensively evaluate the characteristics of antimicrobial research studies registered in ClinicalTrials.gov. Primary outcome measures, funding sources, inclusion criteria and the reporting of study results were evaluated for 16 055 antimicrobial studies registered in ClinicalTrials.gov as of mid 2012. Interventional studies accounted for 93% of registered antimicrobial studies. Clinical trials of drugs (82%) and biologics (9%) were most common. Antibacterial, antiviral and antifungal studies accounted for 43%, 41% and 16% of drug trials, respectively. Among interventional drug trials, 73% featured randomised allocation to study arms and 71% included measures of safety and/or efficacy as primary endpoints. Children were eligible for enrolment in 26% of studies. Among the studies, 60% were sponsored primarily by non-profit organisations, 30% by industry and 10% by the federal government. Only 7% of studies reported results; however, 71% of these were sponsored primarily by industry. Antimicrobial studies commonly incorporated elements of high-quality trial design, including randomisation and safety/efficacy endpoints. Publication of study results and updating of ClinicalTrials.gov should be encouraged for all studies, with particular attention paid to research sponsored by non-profit organisations and governmental agencies. Leveraging the application of these data to guide the careful selection of antimicrobial agents will be essential to preserve their utility for years to come. PMID:23726436
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Work stress among newly graduated nurses in relation to workplace and clinical group supervision.
Blomberg, Karin; Isaksson, Ann-Kristin; Allvin, Renée; Bisholt, Birgitta; Ewertsson, Mona; Kullén Engström, Agneta; Ohlsson, Ulla; Sundler Johansson, Annelie; Gustafsson, Margareta
2016-01-01
The aim was to investigate occupational stress among newly graduated nurses in relation to the workplace and clinical group supervision. Being a newly graduated nurse is particularly stressful. What remains unclear is whether the workplace and clinical group supervision affect the stress. A cross-sectional comparative study was performed in 2012. Data were collected by means of a numerical scale measuring occupational stress, questions about workplace and clinical group supervision. One hundred and thirteen nurses who had recently graduated from three Swedish universities were included in the study. The stress was high among the newly graduated nurses but it differed significantly between workplaces, surgical departments generating the most stress. Nurses who had received clinical group supervision reported significantly less stress. The stress between workplaces remained significant also when participation in clinical group supervision was taken into account. Newly graduated nurses experience great stress and need support, especially those in surgical departments. Nurses participating in clinical group supervision reported significantly less stress. It is important to develop strategies that help to adapt the work situation so as to give nurses the necessary support. Clinical group supervision should be considered as an option for reducing stress. © 2014 John Wiley & Sons Ltd.
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Complementary and alternative medicine usage by patients of a dental school clinic.
Spector, Michael L; Fischer, Mark; Dawson, Deborah V; Holmes, David C; Kummet, Colleen; Nisly, Nicole L; Baker, Karen A K
2012-01-01
This pilot study investigated the prevalence and specific reasons for usage of complementary and alternative medicine (CAM) among patients of a dental school clinic. Four hundred and two patients completed a 30-page survey on CAM usage. A higher rate of CAM usage was found in this dental school clinic population than rates previously reported in a general population. More than three-quarters (76.1%) of the respondents reported using at least one CAM treatment in the past 12 months; 93.3% reported using at least one CAM treatment at some time in their lives. High rates of chiropractic use were found in this population. Tooth pain was the most frequently reported dental condition motivating CAM use. About 10% of dental school clinic patients use topical oral herbal and/or natural products to treat dental conditions, most frequently for preventive/oral health reasons or for tooth pain. © 2012 Special Care Dentistry Association and Wiley Periodicals, Inc.
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Sodium Hypochlorite Accident: A Systematic Review.
Guivarc'h, Maud; Ordioni, Ugo; Ahmed, Hany Mohamed Aly; Cohen, Stephen; Catherine, Jean-Hugues; Bukiet, Frédéric
2017-01-01
Sodium hypochlorite (NaOCl) extrusion beyond the apex, also known as "a hypochlorite accident," is a well-known complication that seldom occurs during root canal therapy. These "accidents" have been the subject of several case reports published over the years. Until now, no publication has addressed the global synthesis of the general and clinical data related to NaOCl extrusion. The main purpose of this article was to conduct a systematic review of previously published case reports to identify, synthesize, and present a critical analysis of the available data. A second purpose was to propose a standardized presentation of reporting data concerning NaOCl extrusions to refine and develop guidelines that should be used in further case report series. A review of clinical cases reporting NaOCl accidents was conducted in June 2016 using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist; it combined an electronic search of the PubMed database and an extensive manual search. Forty full-text articles corresponding to 52 case reports published between 1974 and 2015 were selected. Four main categories of data were highlighted: general and clinical information, clinical signs and symptoms of NaOCl extrusions, management of NaOCl extrusions, and healing and prognosis. Overall, up to now, clinical cases were reported in a very unsystematic manner, and some relevant information was missing. A better understanding of the potential causes, management, and prognosis of NaOCl accidents requires a standardization of reported data; this study proposes a template that can fulfill this objective. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.
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Methodologic ramifications of paying attention to sex and gender differences in clinical research.
Prins, Martin H; Smits, Kim M; Smits, Luc J
2007-01-01
Methodologic standards for studies on sex and gender differences should be developed to improve reporting of studies and facilitate their inclusion in systematic reviews. The essence of these studies lies within the concept of effect modification. This article reviews important methodologic issues in the design and reporting of pharmacogenetic studies. Differences in effect based on sex or gender should preferably be expressed in absolute terms (risk differences) to facilitate clinical decisions on treatment. Information on the distribution of potential effect modifiers or prognostic factors should be available to prevent a biased comparison of differences in effect between genotypes. Other considerations included the possibility of selective nonavailability of biomaterial and the choice of a statistical model to study effect modification. To ensure high study quality, additional methodologic issues should be taken into account when designing and reporting studies on sex and gender differences.
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Bias in reporting of randomised clinical trials in oncology.
Vera-Badillo, Francisco E; Napoleone, Marc; Krzyzanowska, Monika K; Alibhai, Shabbir M H; Chan, An-Wen; Ocana, Alberto; Seruga, Bostjan; Templeton, Arnoud J; Amir, Eitan; Tannock, Ian F
2016-07-01
Bias in reporting efficacy and toxicity in clinical trials may impact treatment decisions. Here, we report quality of reporting of efficacy and of toxicity in articles describing randomised controlled trials (RCTs) of cancer therapy and the association between biased reporting and study results, funding and financial relationships of the authors with the sponsor. We reviewed articles published from July 2010 to December 2012 in six high-impact journals reporting RCTs of systemic treatment for cancer. Bias in reporting of the primary end-point and toxicity were assessed. Associations between biased reporting and study results, funding source and financial ties of the author with the funding source were evaluated using logistic regression. Two hundred articles were identified. Among 107 RCTs where there was no statistically significant difference in the primary end-point between the two arms, 50 (47%) reports used biased reporting in the abstract of the paper to imply benefit of the experimental treatment. Toxicity was not reported in the abstract in 18.5% of the studies and this was associated with a positive primary end-point. Source of funding and financial ties were not associated with biased reporting. Bias in reporting of efficacy outcomes is common for studies with a negative primary end-point and can lead to off-label misuse of experimental therapies, if they are approved for other indications. Toxicity is under-reported, especially for studies with a positive primary end-point, leading to a biased view of the safety of new treatments. Copyright © 2016 Elsevier Ltd. All rights reserved.
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Schoeppe, Franziska; Sommer, Wieland H; Haack, Mareike; Havel, Miriam; Rheinwald, Marika; Wechtenbruch, Juliane; Fischer, Martin R; Meinel, Felix G; Sabel, Bastian O; Sommer, Nora N
2018-01-01
To compare free text (FTR) and structured reports (SR) of videofluoroscopic swallowing studies (VFSS) and evaluate satisfaction of referring otolaryngologists and speech therapists. Both standard FTR and SR of 26 patients with VFSS were acquired. A dedicated template focusing on oropharyngeal phases was created for SR using online software with clickable decision-trees and concomitant generation of semantically structured reports. All reports were evaluated regarding overall quality and content, information extraction and clinical decision support (10-point Likert scale (0 = I completely disagree, 10 = I completely agree)). Two otorhinolaryngologists and two speech therapists evaluated FTR and SR. SR received better ratings than FTR in all items. SR were perceived to contain more details on the swallowing phases (median rating: 10 vs. 5; P < 0.001), penetration and aspiration (10 vs. 5; P < 0.001) and facilitated information extraction compared to FTR (10 vs. 4; P < 0.001). Overall quality was rated significantly higher in SR than FTR (P < 0.001). SR of VFSS provide more detailed information and facilitate information extraction. SR better assist in clinical decision-making, might enhance the quality of the report and, thus, are recommended for the evaluation of VFSS. • Structured reports on videofluoroscopic exams of deglutition lead to improved report quality. • Information extraction is facilitated when using structured reports based on decision trees. • Template-based reports add more value to clinical decision-making than free text reports. • Structured reports receive better ratings by speech therapists and otolaryngologists. • Structured reports on videofluoroscopic exams may improve the comparability between exams.
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National survey on current situation of critical value reporting in 973 laboratories in China.
Fei, Yang; Zhao, Haijian; Wang, Wei; He, Falin; Zhong, Kun; Yuan, Shuai; Wang, Zhiguo
2017-10-15
The aim of the study was to investigate the state-of-the-art of the performance of critical value reporting and provide recommendations for laboratories setting critical value reporting time frames. The National Centre for Clinical Laboratories in China initiated a critical value reporting investigation in 2015. A questionnaire related to critical value reporting policy was sent to 1589 clinical laboratories in China online. The questionnaire consisted of a set of questions related to critical value reporting policy and a set of questions related to timeliness of critical value reporting. The survey data were collected between March and April 2015. A total survey response rate was 61.2%. The critical value unreported rate, unreported timely rate, and clinical unacknowledged rate of more than half of participants were all 0.0%. More than 75.0% of participants could report half of critical values to clinicians within 20 minutes and could report 90.0% of critical values to clinicians within 25 minutes (from result validation to result communication to the clinician). The median of target critical value reporting time was 15 minutes. "Reporting omission caused by laboratory staff", "communications equipment failure to connect", and "uncompleted application form without contact information of clinician" were the three major reasons for unreported critical value. The majority of laboratories can report critical values to responsible clinical staff within 25 minutes. Thus, this value could be recommended as suitable critical value reporting time frame for biochemistry laboratories in China. However, careful monitoring of the complete reporting process and improvement of information systems should ensure further improvement of critical value reporting timeliness.
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George, Steven Z; Wittmer, Virgil T; Fillingim, Roger B; Robinson, Michael E
2006-03-01
Quantitative sensory testing has demonstrated a promising link between experimentally determined pain sensitivity and clinical pain. However, previous studies of quantitative sensory testing have not routinely considered the important influence of psychological factors on clinical pain. This study investigated whether measures of thermal pain sensitivity (temporal summation, first pulse response, and tolerance) contributed to clinical pain reports for patients with chronic low back pain, after controlling for depression or fear-avoidance beliefs about work. Consecutive patients (n=27) with chronic low back pain were recruited from an interdisciplinary pain rehabilitation program in Jacksonville, FL. Patients completed validated self-report questionnaires for depression, fear-avoidance beliefs, clinical pain intensity, and clinical pain related disability. Patients also underwent quantitative sensory testing from previously described protocols to determine thermal pain sensitivity (temporal summation, first pulse response, and tolerance). Hierarchical regression models investigated the contribution of depression and thermal pain sensitivity to clinical pain intensity, and fear-avoidance beliefs and thermal pain sensitivity to clinical pain related disability. None of the measures of thermal pain sensitivity contributed to clinical pain intensity after controlling for depression. Temporal summation of evoked thermal pain significantly contributed to clinical pain disability after controlling for fear-avoidance beliefs about work. Measures of thermal pain sensitivity did not contribute to pain intensity, after controlling for depression. Fear-avoidance beliefs about work and temporal summation of evoked thermal pain significantly influenced pain related disability. These factors should be considered as potential outcome predictors for patients with work-related low back pain. This study supported the neuromatrix theory of pain for patients with CLBP, as cognitive-evaluative factor contributed to pain perception, and cognitive-evaluative and sensory-discriminative factors uniquely contributed to an action program in response to chronic pain. Future research will determine if a predictive model consisting of fear-avoidance beliefs and temporal summation of evoked thermal pain has predictive validity for determining clinical outcome in rehabilitation or vocational settings.
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"Are We hurting ourselves?" What is the prevalence of back pain in anesthesia providers?
Anson, Jonathan A; Mets, Elbert J; Vaida, Sonia J; King, Tonya S; Ochoa, Tim; Gordin, Vitaly
2016-11-01
Back injuries are a highly reported category of occupational injury in the health care setting. The daily clinical activities of an anesthesia provider, including lifting, pushing stretchers, transferring patients, and bending for procedures, are risk factors for developing low back pain. The purpose of this study is to investigate the prevalence of work related low back pain in anesthesia providers. We conducted a cross-sectional survey study of anesthesia providers at an academic institution. The target population included all 141 clinical anesthesia providers employed by the Penn State Milton S. Hershey Medical Center Department of Anesthesia. A survey study was conducted using the Oswestry Disability Index (ODI), a validated scoring system for low back pain. Additional questions related to the daily activities of clinical anesthesia practice were also asked. The survey instrument underwent pretesting and clinical sensibility testing to ensure validity and consistent interpretation. The primary self-reported measures were the prevalence of low back pain in anesthesia providers and an assessment of disability based on the ODI. Secondary functional measures included the impact of low back pain on work flow. Nearly half (46.6%) of respondents suffer from low back pain attributed to clinical practice. In this subset of respondents, 70.1% reported not having back pain prior to their anesthesia training. Of those with low back pain, 44% alter their work flow, and 9.8% reported missing at least one day of work. Six providers (5.3%) required surgical intervention. Using the ODI score interpretation guidelines, 46% of respondents had a "mild disability" and 2% had a "moderate disability." Respondents reporting feeling "burned out" from their job had a significantly higher average ODI score compared to those who did not (6.8 vs 3.3, respectively; P=.01). Nearly half of all anesthesia providers sampled suffer from low back pain subjectively attributed to their clinical practice. This leads to changes in work flow and missed days of work. The results of this study suggest a deficiency in the effectiveness of anesthesia training programs in teaching proper techniques to prevent musculoskeletal injuries. Copyright © 2016 Elsevier Inc. All rights reserved.
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Smith, Chris; Edwards, Phil; Free, Caroline
2018-03-15
A variety of different approaches to measuring contraceptive use have been used or proposed, either to assess current use or adherence over time, using subjective or objective measures. This paper reports an overview of approaches to measuring adherence to the oral contraceptive, intra-uterine device, sub-dermal implant, and injectable and describes how we assessed contraception use in the MObile Technology for Improved Family Planning (MOTIF) trial in Cambodia. We summarise and discuss advantages and disadvantages of different subjective and objective approaches to measuring adherence to the oral contraceptive, intra-uterine device, sub-dermal implant, and injectable such as self-reports, clinic records, electronic monitoring devices, clinical examination and biomarkers. For the MOTIF trial, we did not consider it feasible to measure objective contraception use as many participants lived a long distance from the clinic and we were concerned whether it was appropriate to ask women to return to clinic for a physical examination simply to verify self-report information already provided. We aimed to assess the validity of the four-month data with 50 participants, calculating the sensitivity and specificity of self-reported data compared with objective measurement. For the 46 valid measurements obtained, the sensitivity and specificity was 100% for self-reported contraception use compared to objective measurement but this study had some limitations. To assess reliability of self-report data we compared calendar data collected on effective contraception use at months 1-4 post-abortion, collected separately at four and 12 months. Agreement ranged from 80 to 84% with a kappa statistic ranging from 0·59 to 0·67 indicating fair to good agreement. There is no perfect method of assessing contraception use and researchers designing future studies should give consideration of what to measure, for example current use or detailed patterns of use over time, and remain mindful of what will be feasible and acceptable to the study population. Although self-reported data on contraception use are considered less reliable, and prone to social desirability bias, it is often the standard approach for contraception research and provides data comparable to previous studies. ClinicalTrials.gov Identifier: NCT01823861 . Registered: March 30, 2013.
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Basker, Parasuraman; Kannan, Pichai; Kolandaswamy, Karumana Gounder
2014-01-01
Objectives To know the prevalence of leptospirosis cases reported in private clinics among fever cases in Villupuram District, Tamil Nadu, India to know its real magnitude of the problem and to diagnose Leptospirosis among fever cases from differential diagnosis. Methods 1502 Blood serum samples collected from three urban towns namely Kallakurichi (Latitude: 11° 73′ N; Longitude: 78° 97′ E), Villupuram (Latitude: 11° 75′ N; Longitude: 79° 92′ E) and Thindivanam (Latitude: 12° 25′ N; Longitude: 79° 65′ E) in fifteen clinics based on case definition of leptospirosis delineated by the National Vector Borne Disease Control Programme (NVBDCP), Government of India. Samples were tested in the laboratory of the Zonal Entomological Team (ZET), Cuddalore with Macroscopic Slide Agglutination Test (MSAT) and Ig-M ELISA. Result There were 65 positive cases detected from 1502 blood serum samples in both MSAT and Ig-M ELISA. It could be known that there was 4% cases contributed from private clinics among fever cases. From this study, further it was known that all age groups of people affected irrespective of sexes based on their living condition associated with the environment prevailed of the disease. Conclusion From this study, it was quantified that 4% of cases reported in private clinics among fever cases and its findings ascertained both the importance of differential diagnosis as well as reports that should be included to the Government for knowing its real magnitude for planning. PMID:24955313
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Safety of meropenem in patients reporting penicillin allergy: lack of allergic cross reactions.
Cunha, B A; Hamid, N S; Krol, V; Eisenstein, L
2008-04-01
Over the years, meropenem has become the mainstay of empiric therapy for serious systemic infections in critically ill patients. Although we have had extensive clinical experience since 1996 using meropenem safely in treating hundreds of patients with reported allergic reactions to penicillin without any adverse events, we have not published our experience. This study was conducted to document our clinical practice experience. Accordingly, over a 12-month period we prospectively monitored 110 patients treated with meropenem reporting penicillin allergic reactions for that 12-month period. Since early empiric therapy in such patients is essential, there is often no time for penicillin skin testing. Penicillin skin testing was not done in this "real world" clinical study. Patients were divided into two groups, depending on the nature of their penicillin allergic reactions. During a 12-month period, 110 patients with non-anaphylactic (59) and anaphylactic (51) penicillin allergic reactions tolerated prolonged meropenem therapy (1-4 weeks) safely without any allergic reactions. Based on these data and our previous clinical experience, there appears to be little/no potential cross reactivity between meropenem and penicillins even in patients with a definite history of anaphylactic reactions to penicillins. To the best of our knowledge, this is the first prospective clinical study demonstrating that meropenem may be safely given to patients with known/unknown allergic reactions to penicillin, including those with anaphylactic reactions, without penicillin skin testing. We conclude that meropenem may be given safely to patients reporting a history of non-anaphylactic or anaphylactic allergic reactions to penicillins without penicillin skin testing.
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2013-01-01
Background The cost to the NHS of missed or inappropriate hospital appointments is considerable. Alternative methods of appointment scheduling might be more flexible to patients’ needs without jeopardising health and service quality. The objective was to systematically review evidence of patient initiated clinics in secondary care on patient reported outcomes among patients with chronic/recurrent conditions. Methods Seven databases were searched from inception to June 2013. Hand searching of included studies references was also conducted. Studies comparing the effects of patient initiated clinics with traditional consultant led clinics in secondary care for patients with long term chronic or recurrent diseases on health related quality of life and/or patient satisfaction were included. Data was extracted by one reviewer and checked by a second. Results were synthesised narratively. Results Seven studies were included in the review, these covered a total of 1,655 participants across three conditions: breast cancer, inflammatory bowel disease and rheumatoid arthritis. Quality of reporting was variable. Results showed no significant differences between the intervention and control groups for psychological and health related quality of life outcomes indicating no evidence of harm. Some patients reported significantly more satisfaction using patient-initiated clinics than usual care (p < 0.001). Conclusions The results show potential for patient initiated clinics to result in greater patient and clinician satisfaction. The patient-consultant relationship appeared to play an important part in patient satisfaction and should be considered an important area of future research as should the presence or absence of a guidebook to aid self-management. Patient initiated clinics fit the models of care suggested by policy makers and so further research into long term outcomes for patients and service use in this area of practice is both relevant and timely. PMID:24289832
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Reference values for clinical laboratory parameters in young adults in Maputo, Mozambique.
Tembe, Nelson; Joaquim, Orvalho; Alfai, Eunice; Sitoe, Nádia; Viegas, Edna; Macovela, Eulalia; Gonçalves, Emilia; Osman, Nafissa; Andersson, Sören; Jani, Ilesh; Nilsson, Charlotta
2014-01-01
Clinical laboratory reference values from North American and European populations are currently used in most Africans countries due to the absence of locally derived reference ranges, despite previous studies reporting significant differences between populations. Our aim was to define reference ranges for both genders in 18 to 24 year-old Mozambicans in preparation for clinical vaccine trials. A cross-sectional study including 257 volunteers (102 males and 155 females) between 18 and 24 years was performedat a youth clinic in Maputo, Mozambique. All volunteers were clinically healthy and human immunodeficiency virus, Hepatitis B virus and syphilis negative.Median and 95% reference ranges were calculated for immunological, hematological and chemistry parameters. Ranges were compared with those reported based on populations in other African countries and the US. The impact of applying US NIH Division of AIDS (DAIDS) toxicity tables was assessed. The immunology ranges were comparable to those reported for the US and western Kenya.There were significant gender differences in CD4+ T cell values 713 cells/µL in males versus 824 cells/µL in females (p<0.0001). Hematologic values differed from the US values but were similar to reports of populations in western Kenya and Uganda. The lower and upper limits of the ranges for hemoglobin, hematocrit, red blood cells, white blood cells and lymphocytes were somewhat lower than those from these African countries. The chemistry values were comparable to US values, with few exceptions. The upper limits for ALT, AST, bilirubin, cholesterol and triglycerides were higher than those from the US. DAIDStables for adverse events predicted 297 adverse events and 159 (62%) of the volunteers would have been excluded. This study is the first to determine normal laboratory parameters in Mozambique. Our results underscore the necessity of establishing region-specific clinical reference ranges for proper patient management and safe conduct of clinical trials.
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Facilitating Case Studies in Massage Therapy Clinical Education
Baskwill, Amanda
2013-01-01
The integration of evidence into reflective health care practice has been on the rise in recent years and is a phenomenon that has affected all health care professions, including massage therapy. Clinical case studies are a research design that follows one patient or subject, making the studies ideal for use in clinical practice. They are valuable for communicating information from clinical practice to the broader community. Case studies have face validity that may be more valuable to individual practitioners than homogeneous randomized controlled trials, as the practitioner may recognize a complex patient in the case report. At Humber College, Student Massage Therapists (SMTs) create, conduct, and communicate results of a clinical case study prior to graduation. This article describes the process and experience. PMID:23730397
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Miller, Elizabeth; Decker, Michele R.; McCauley, Heather L.; Tancredi, Daniel J.; Levenson, Rebecca R.; Waldman, Jeffrey; Schoenwald, Phyllis; Silverman, Jay G.
2010-01-01
Background This study examined the efficacy of a family planning clinic-based intervention to address intimate partner violence (IPV) and reproductive coercion. Study Design Four free-standing urban family planning clinics in Northern California were randomized to intervention (trained family planning counselors) or standard-of-care. English-and Spanish-speaking females ages 16-29 years (N=906) completed audio computer-assisted surveys prior to a clinic visit and 12 to 24 weeks later (75% retention rate). Analyses included assessment of intervention effects on recent IPV, awareness of IPV services, and reproductive coercion. Results Among women reporting past 3-month IPV at baseline, there was a 71% reduction in the odds of pregnancy coercion among participants in intervention clinics compared to participants from the control clinics that provided standard of care. Women in the intervention arm were more likely to report ending a relationship because the relationship was unhealthy or unsafe regardless of IPV status (AOR 1.63, 95% CI 1.01 – 2.63). Conclusions Results of this pilot study suggest that this intervention may reduce risk for reproductive coercion from abusive male partners among family planning clients and support such women to leave unsafe relationships. PMID:21310291
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2012-01-01
Background There are numerous applications for Health Information Systems (HIS) that support specific tasks in the clinical workflow. The Lean method has been used increasingly to optimize clinical workflows, by removing waste and shortening the delivery cycle time. There are a limited number of studies on Lean applications related to HIS. Therefore, we applied the Lean method to evaluate the clinical processes related to HIS, in order to evaluate its efficiency in removing waste and optimizing the process flow. This paper presents the evaluation findings of these clinical processes, with regards to a critical care information system (CCIS), known as IntelliVue Clinical Information Portfolio (ICIP), and recommends solutions to the problems that were identified during the study. Methods We conducted a case study under actual clinical settings, to investigate how the Lean method can be used to improve the clinical process. We used observations, interviews, and document analysis, to achieve our stated goal. We also applied two tools from the Lean methodology, namely the Value Stream Mapping and the A3 problem-solving tools. We used eVSM software to plot the Value Stream Map and A3 reports. Results We identified a number of problems related to inefficiency and waste in the clinical process, and proposed an improved process model. Conclusions The case study findings show that the Value Stream Mapping and the A3 reports can be used as tools to identify waste and integrate the process steps more efficiently. We also proposed a standardized and improved clinical process model and suggested an integrated information system that combines database and software applications to reduce waste and data redundancy. PMID:23259846
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Yusof, Maryati Mohd; Khodambashi, Soudabeh; Mokhtar, Ariffin Marzuki
2012-12-21
There are numerous applications for Health Information Systems (HIS) that support specific tasks in the clinical workflow. The Lean method has been used increasingly to optimize clinical workflows, by removing waste and shortening the delivery cycle time. There are a limited number of studies on Lean applications related to HIS. Therefore, we applied the Lean method to evaluate the clinical processes related to HIS, in order to evaluate its efficiency in removing waste and optimizing the process flow. This paper presents the evaluation findings of these clinical processes, with regards to a critical care information system (CCIS), known as IntelliVue Clinical Information Portfolio (ICIP), and recommends solutions to the problems that were identified during the study. We conducted a case study under actual clinical settings, to investigate how the Lean method can be used to improve the clinical process. We used observations, interviews, and document analysis, to achieve our stated goal. We also applied two tools from the Lean methodology, namely the Value Stream Mapping and the A3 problem-solving tools. We used eVSM software to plot the Value Stream Map and A3 reports. We identified a number of problems related to inefficiency and waste in the clinical process, and proposed an improved process model. The case study findings show that the Value Stream Mapping and the A3 reports can be used as tools to identify waste and integrate the process steps more efficiently. We also proposed a standardized and improved clinical process model and suggested an integrated information system that combines database and software applications to reduce waste and data redundancy.
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Differences between reported and actual restored caries lesion depths: results from The Dental PBRN.
Rindal, D B; Gordan, V V; Fellows, J L; Spurlock, N L; Bauer, M R; Litaker, M S; Gilbert, G H
2012-03-01
The objectives of this research were to (1) quantify the discordance between the caries lesion depth at which dentists restored initial lesions during a clinical study ("actual depth") and the lesion depth that they reported during a hypothetical clinical scenario ("reported depth"); (2) test the hypothesis that certain practitioner, practice, patient, and caries lesion characteristics are significantly associated with this discordance. Practitioner-investigators who perform restorative dentistry in their practices completed an enrollment questionnaire and participated in two consecutive studies on caries diagnosis and treatment. The first study was a survey asking about caries treatment. The second study collected data on restorations placed in routine clinical practice due to caries in patients over 19 years of age on occlusal surfaces only or proximal surfaces only. We report results on 2691 restorations placed by 205 dentists in 1930 patients with complete data. Discordance between actual depth and reported depth occurred in only about 2% of the restorations done due to proximal caries, but about 49% of the restorations done due to occlusal caries. Practice type, restorative material used and the diagnostic methods used were significantly associated with discordance. Dentists frequently restored occlusal caries at a shallower depth as compared to their reported depth, but the discordance was very small for proximal lesions. Discordance for occlusal caries was more common when radiographs were not taken or if a resin restoration was placed. Copyright © 2011 Elsevier Ltd. All rights reserved.
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Best clinical trials reported in 2010.
Garner, John B; Grayburn, Paul A; Yancy, Clyde W
2011-07-01
Each year, a number of clinical trials emerge with data sufficient to change clinical practice. Determining which findings will result in practice change and which will provide only incremental benefit can be a dilemma for clinicians. The authors review selected clinical trials reported in 2010 in journals, at society meetings, and at conferences, focusing on those studies that have the potential to change clinical practice. This review offers 3 separate means of analysis: an abbreviated text summary, organized by subject area; a comprehensive table of relevant clinical trials that provides a schematic review of the hypotheses, interventions, methods, primary end points, results, and implications; and a complete bibliography for further reading as warranted. It is hoped that this compilation of relevant clinical trials and their important findings released in 2010 will be of benefit in the everyday practice of cardiovascular medicine. Copyright © 2011 Elsevier Inc. All rights reserved.
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A survey of general practitioners' views on autopsy reports.
Karunaratne, S; Benbow, E W
1997-01-01
AIMS: To study the views of general practitioners on the quality and utility of autopsy reports, and on autopsies in general. METHODS: For a period of six months, a questionnaire was enclosed with each autopsy report sent to a general practitioner from the mortuary at Manchester Royal Infirmary. RESULTS: Most (93.3%) general practitioners found the autopsy report useful, and many (66.7%) thought the bereaved relatives would do so too. However, only a minority (25.2%) would discuss the report with the relatives. A considerable proportion (20.0%) found the cause of death surprising, and a significant number (10.4%) felt the report would modify their future clinical practice. There was approval of autopsies in general, with most (88.6%) agreeing that autopsies reveal lesions not detected in life, and many (74.4%) indicating that loss of the autopsy would impair severely the monitoring of clinical standards. CONCLUSIONS: General practitioners appreciate autopsy reports, which may have a significant impact on clinical practice. Autopsy reports provide both case audit and information for relatives. PMID:9306932
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Iten, A Elizabeth; Jacobs, Elizabeth A; Lahiff, Maureen; Fernández, Alicia
2014-04-01
The objective of this study is to investigate the relationship between immigration status and the patient experience of health care, diabetes self-management, and clinical outcomes among Mexican immigrants with diabetes receiving health care in two immigration sanctuary cities. We used data from the Immigration, Culture and Health Care study, a cross-sectional survey and medical record study of low-income patients with diabetes recruited from public hospitals and community clinics in the San Francisco Bay Area and Chicago. Undocumented Mexican, documented Mexican immigrants, and US-born Mexican-Americans' health care experiences, diabetes self-management, and clinical outcomes were compared using multivariate linear and logistic regressions. We found no significant differences in reports of physician communication, or in measures of diabetes management between undocumented and documented immigrants. All three groups had similar clinical outcomes in glycemic, systolic blood pressure, and lipid control. These results indicate that, at least in some settings, undocumented Mexican immigrants with diabetes can achieve similar clinical outcomes and report similar health care experiences as documented immigrants and US-born Mexican-Americans.
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The psychiatric report as moral tool: a case study in a French district court.
Fernandez, Fabrice; Lézé, Samuel
2014-09-01
Mental health evaluation within a legal setting is widely seen as a power to judge. The aim of this paper is to challenge this current thesis, which was popularised by Michel Foucault, who encapsulated the notion in a brief sentence: "The sordid business of punishing is thus converted into the fine profession of curing" (Foucault, 2003: 23). On the basis of an ethnography of a French district court (between September 2008 and May 2009, n = 60 trials) including interviews with judges (n = 10) and psychiatrists (n = 10), we study the everyday penal treatment of sexual offenders using psychiatric reports. Our findings show how (i.) the expectations of the judges select the psychiatrists' skills (based on the following criteria for their reports: accessibility of knowledge, singularization and individualization of content) and (ii.) reframe the psychiatric report as a moral tool. The clinical reasoning of forensic psychiatrists in their reports offer moral affordances due to their clinical caution regarding the risk of recidivism (therapeutic and criminological reversal, moral prevention). Both the judges' evaluation and the psychiatrists' clinical authority are shaped by a moral economy of dangerousness, which eclipses the idea of lack of criminal responsibility. In conclusion, we show that these unintended effects are necessarily of interest to most clinical practitioners engaged in work as expert witnesses. Copyright © 2014 Elsevier Ltd. All rights reserved.
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The effects of implementing synoptic pathology reporting in cancer diagnosis: a systematic review.
Sluijter, Caro E; van Lonkhuijzen, Luc R C W; van Slooten, Henk-Jan; Nagtegaal, Iris D; Overbeek, Lucy I H
2016-06-01
Pathology reporting is evolving from a traditional narrative report to a more structured synoptic report. Narrative reporting can cause misinterpretation due to lack of information and structure. In this systematic review, we evaluate the impact of synoptic reporting on completeness of pathology reports and quality of pathology evaluation for solid tumours. Pubmed, Embase and Cochrane databases were systematically searched to identify studies describing the effect of synoptic reporting implementation on completeness of reporting and quality of pathology evaluation of solid malignant tumours. Thirty-three studies met the inclusion criteria. All studies, except one, reported an increased overall completeness of pathology reports after introduction of synoptic reporting (SR). Most frequently studied cancers were breast (n = 9) and colorectal cancer (n = 16). For breast cancer, narrative reports adequately described 'tumour type' and 'nodal status'. Synoptic reporting resulted in improved description of 'resection margins', 'DCIS size', 'location' and 'presence of calcifications'. For colorectal cancer, narrative reports adequately reported 'tumour type', 'invasion depth', 'lymph node counts' and 'nodal status'. Synoptic reporting resulted in increased reporting of 'circumferential margin', 'resection margin', 'perineural invasion' and 'lymphovascular invasion'. In addition, increased numbers of reported lymph nodes were found in synoptic reports. Narrative reports of other cancer types described the traditional parameters adequately, whereas for 'resection margins' and '(lympho)vascular/perineural invasion', implementation of synoptic reporting was necessary. Synoptic reporting results in improved reporting of clinical relevant data. Demonstration of clinical impact of this improved method of pathology reporting is required for successful introduction and implementation in daily pathology practice.
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Rosas, Scott R; Cope, Marie T; Villa, Christie; Motevalli, Mahnaz; Utech, Jill; Schouten, Jeffrey T
2014-04-01
Large-scale, multi-network clinical trials are seen as a means for efficient and effective utilization of resources with greater responsiveness to new discoveries. Formal structures instituted within the National Institutes of Health (NIH) HIV/AIDS Clinical Trials facilitate collaboration and coordination across networks and emphasize an integrated approach to HIV/AIDS vaccine, prevention and therapeutics clinical trials. This study examines the joint usage of clinical research sites as means of gaining efficiency, extending capacity, and adding scientific value to the networks. A semi-structured questionnaire covering eight clinical management domains was administered to 74 (62% of sites) clinical site coordinators at single- and multi-network sites to identify challenges and efficiencies related to clinical trials management activities and coordination with multi-network units. Overall, respondents at multi-network sites did not report more challenges than single-network sites, but did report unique challenges to overcome including in the areas of study prioritization, community engagement, staff education and training, and policies and procedures. The majority of multi-network sites reported that such affiliations do allow for the consolidation and cost-sharing of research functions. Suggestions for increasing the efficiency or performance of multi-network sites included streamlining standards and requirements, consolidating protocol activation methods, using a single cross-network coordinating centre, and creating common budget and payment mechanisms. The results of this assessment provide important information to consider in the design and management of multi-network configurations for the NIH HIV/AIDS Clinical Trials Networks, as well as others contemplating and promoting the concept of multi-network settings. © 2013 John Wiley & Sons Ltd.
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Regulatory approval of new medical devices: cross sectional study.
Marcus, Hani J; Payne, Christopher J; Hughes-Hallett, Archie; Marcus, Adam P; Yang, Guang-Zhong; Darzi, Ara; Nandi, Dipankar
2016-05-20
To investigate the regulatory approval of new medical devices. Cross sectional study of new medical devices reported in the biomedical literature. PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval. Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article." Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device. 5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be "substantially equivalent" to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published. We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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Siska, William; Gupta, Aradhana; Tomlinson, Lindsay; Tripathi, Niraj; von Beust, Barbara
Clinical pathology testing is routinely performed in target animal safety studies in order to identify potential toxicity associated with administration of an investigational veterinary pharmaceutical product. Regulatory and other testing guidelines that address such studies provide recommendations for clinical pathology testing but occasionally contain outdated analytes and do not take into account interspecies physiologic differences that affect the practical selection of appropriate clinical pathology tests. Additionally, strong emphasis is often placed on statistical analysis and use of reference intervals for interpretation of test article-related clinical pathology changes, with limited attention given to the critical scientific review of clinically, toxicologically, or biologically relevant changes. The purpose of this communication from the Regulatory Affairs Committee of the American Society for Veterinary Clinical Pathology is to provide current recommendations for clinical pathology testing and data interpretation in target animal safety studies and thereby enhance the value of clinical pathology testing in these studies.
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Psychological and Social Predictors of Suicidal Ideation among Young Adolescents
ERIC Educational Resources Information Center
Kirkcaldy, Bruce D.; Eysenck, Michael W.; Siefen, Georg R.
2004-01-01
Although there is an enormous amount of literature demonstrating socio-psychological determinants of suicide and self-injurious behaviour among adults or clinical samples of children and adolescents, there is a scarcity of studies focussing on non-clinical adolescent samples. The current study examined associations between self-reported data on…
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Clinical Use of the Marital Satisfaction Inventory: Two Case Studies.
ERIC Educational Resources Information Center
Wills, Robert M.; Snyder, Douglas K.
1982-01-01
Describes the clinical use of the Marital Satisfaction Inventory (MSI), a multidimensional self-report measure of marital interaction. Two case studies of couples in marital therapy are presented. The MSI is presented as a cost-efficient procedure, permitting objective assessment across multiple areas of a couple's relationship. (Author/JAC)
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ERIC Educational Resources Information Center
Garrido, Melissa Downey
2012-01-01
The national call to "turn [teacher education] upside down" (National Council for Accreditation of Teacher Education, Report of the Blue Ribbon Panel on Clinical Preparation and Partnerships for Improved Student Learning [NCATE], 2010, p. ii) and states' subsequent commitments to pilot recommendations necessitates study of successful…
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McCabe, Martin G.; Bäcklund, L. Magnus; Leong, Hui Sun; Ichimura, Koichi; Collins, V. Peter
2011-01-01
Current risk stratification schemas for medulloblastoma, based on combinations of clinical variables and histotype, fail to accurately identify particularly good- and poor-risk tumors. Attempts have been made to improve discriminatory power by combining clinical variables with cytogenetic data. We report here a pooled analysis of all previous reports of chromosomal copy number related to survival data in medulloblastoma. We collated data from previous reports that explicitly quoted survival data and chromosomal copy number in medulloblastoma. We analyzed the relative prognostic significance of currently used clinical risk stratifiers and the chromosomal aberrations previously reported to correlate with survival. In the pooled dataset metastatic disease, incomplete tumor resection and severe anaplasia were associated with poor outcome, while young age at presentation was not prognostically significant. Of the chromosomal variables studied, isolated 17p loss and gain of 1q correlated with poor survival. Gain of 17q without associated loss of 17p showed a trend to improved outcome. The most commonly reported alteration, isodicentric chromosome 17, was not prognostically significant. Sequential multivariate models identified isolated 17p loss, isolated 17q gain, and 1q gain as independent prognostic factors. In a historical dataset, we have identified isolated 17p loss as a marker of poor outcome and 17q gain as a novel putative marker of good prognosis. Biological markers of poor-risk and good-risk tumors will be critical in stratifying treatment in future trials. Our findings should be prospectively validated independently in future clinical studies. PMID:21292688
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Fiteni, Frédéric; Anota, Amélie; Westeel, Virginie; Bonnetain, Franck
2016-02-18
Health-related quality of life (HRQoL) is recognized as a component endpoint for cancer therapy approvals. The aim of this review was to evaluate the methodology of HRQoL analysis and reporting in phase III clinical trials of first-line chemotherapy in advanced non-small cell lung cancers (NSCLC). A search in MEDLINE databases identified phase III clinical trials in first-line chemotherapy for advanced NSCLC, published between January 2008 to December 2014. Two authors independently extracted information using predefined data abstraction forms. A total of 55 phase III advanced NSCLC trials were identified. HRQoL was declared as an endpoint in 27 studies (49%). Among these 27 studies, The EORTC questionnaire Quality of Life Questionnaire C30 was used in 13 (48%) of the studies and The Functional Assessment of Cancer Therapy-General was used in 12 (44%) trials. The targeted dimensions of HRQoL, the minimal clinically important difference and the statistical approaches for dealing with missing data were clearly specified in 13 (48.1%), 9 (33.3%) and 5 (18.5%) studies, respectively. The most frequent statistical methods for HRQoL analysis were: the mean change from baseline (33.3%), the linear mixed model for repeated measures (22.2%) and time to HRQoL score deterioration (18.5%). For each targeted dimension, the results for each group, the estimated effect size and its precision were clearly reported in 4 studies (14.8%), not clearly reported in 11 studies (40.7%) and not reported at all in 12 studies (44.4%). This review demonstrated the weakness and the heterogeneity of the measurement, analysis, and reporting of HRQoL in phase III advanced NSCLC trials. Precise and uniform recommendations are needed to compare HRQoL results across publications and to provide understandable messages for patients and clinicians.
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Bonnett, Laura Jayne; Ken-Dror, Gie; Davies, Geraint Rhys
2018-02-21
Despite more than 60 years of clinical trials, tuberculosis (TB) still causes a high global burden of mortality and morbidity. Treatment currently requires multiple drugs in combination, taken over a prolonged period. New drugs are needed to shorten treatment duration, prevent resistance and reduce adverse events. However, to improve on current methodology in drug development, a more complete understanding of the existing clinical evidence base is required. A systematic review was undertaken to summarise outcomes reported in phase III trials of patients with newly diagnosed pulmonary TB. A systematic search of databases (PubMed, MEDLINE, EMBASE, CENTRAL and LILACs) was conducted on 30 November 2017 to retrieve relevant peer-reviewed articles. Reference lists of included studies were also searched. This systematic review considered all reported outcomes. Of 248 included studies, 229 considered "on-treatment" outcomes whilst 148 reported "off-treatment" outcomes. There was wide variation and ambiguity in the definition of reported outcomes, including their relationship to treatment and in the time points evaluated. Additional challenges were observed regarding the analysis approach taken (per protocol versus intention to treat) and the varying durations of "intensive" and "continuation" phases of treatment. Bacteriological outcomes were most frequently reported but radiological and clinical data were often included as an implicit or explicit component of the overall definition of outcome. Terminology used to define long-term outcomes in phase III trials is inconsistent, reflecting evolving differences in protocols and practices. For successful future cumulative meta-analysis, the findings of this review suggest that greater availability of individual patient data and the development of a core outcome set would be desirable. In the meantime, we propose a simple and logical approach which should facilitate combination of key evidence and inform improvements in the methodology of TB drug development and clinical trials.
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Relevance of randomised controlled trials in oncology.
Tannock, Ian F; Amir, Eitan; Booth, Christopher M; Niraula, Saroj; Ocana, Alberto; Seruga, Bostjan; Templeton, Arnoud J; Vera-Badillo, Francisco
2016-12-01
Well-designed randomised controlled trials (RCTs) can prevent bias in the comparison of treatments and provide a sound basis for changes in clinical practice. However, the design and reporting of many RCTs can render their results of little relevance to clinical practice. In this Personal View, we discuss the limitations of RCT data and suggest some ways to improve the clinical relevance of RCTs in the everyday management of patients with cancer. RCTs should ask questions of clinical rather than commercial interest, avoid non-validated surrogate endpoints in registration trials, and have entry criteria that allow inclusion of all patients who are fit to receive treatment. Furthermore, RCTs should be reported with complete accounting of frequency and management of toxicities, and with strict guidelines to ensure freedom from bias. Premature reporting of results should be avoided. The bar for clinical benefit should be raised for drug registration, which should require publication and review of mature data from RCTs, post-marketing health outcome studies, and value-based pricing. Copyright © 2016 Elsevier Ltd. All rights reserved.
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Elbers, A R W; Gorgievski-Duijvesteijn, M J; van der Velden, P G; Loeffen, W L A; Zarafshani, K
2010-04-21
The aim of this study was to identify limitations and incentives in reporting clinically suspect situations, possibly caused by classical swine fever (CSF), to veterinary authorities with the ultimate aim to facilitate early detection of CSF outbreaks. Focus group sessions were held with policy makers from the veterinary authorities, and representatives of veterinary practitioners and pig farmer unions. Personal interviews with a small group of pig farmers and practitioners were held to check limitations raised and solutions proposed during the focus group sessions. An electronic questionnaire was mailed to pig farmers and practitioners to investigate perceptions and attitudes with respect to clinically suspect situations possibly caused by CSF. After triangulating the responses of veterinary authorities, veterinary practitioners and farmers, six themes emerged across all groups: (1) lack of knowledge on the early signs of CSF; (2) guilt, shame and prejudice; (3) negative opinion on control measures; (4) dissatisfaction with post-reporting procedures; (5) lack of trust in government bodies; (6) uncertainty and lack of transparency of reporting procedures. The following solutions to facilitate early detection of CSF were put forward: (a) development of a clinical decision-support system for vets and farmers, in order to get faster diagnosis and detection of CSF; (b) possibility to submit blood samples directly to the reference laboratory to exclude CSF in a clinical situation with non-specific clinical signs, without isolation of the farm and free of charge for the individual farmer; (c) decrease social and economic consequences of reporting CSF, for example by improving the public opinion on first reports; (d) better schooling of veterinary officers to deal with emotions and insecurity of farmers in the process after reporting; (e) better communication of rules and regulations, where to report, what will happen next; (f) up-to-date website with information and visual material of the clinical signs of CSF. Copyright 2009 Elsevier B.V. All rights reserved.
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Dakin, Helen; Abel, Lucy; Burns, Richéal; Yang, Yaling
2018-02-12
The Health Economics Research Centre (HERC) Database of Mapping Studies was established in 2013, based on a systematic review of studies developing mapping algorithms predicting EQ-5D. The Mapping onto Preference-based measures reporting Standards (MAPS) statement was published in 2015 to improve reporting of mapping studies. We aimed to update the systematic review and assess the extent to which recently-published studies mapping condition-specific quality of life or clinical measures to the EQ-5D follow the guidelines published in the MAPS Reporting Statement. A published systematic review was updated using the original inclusion criteria to include studies published by December 2016. We included studies reporting novel algorithms mapping from any clinical measure or patient-reported quality of life measure to either the EQ-5D-3L or EQ-5D-5L. Titles and abstracts of all identified studies and the full text of papers published in 2016 were assessed against the MAPS checklist. The systematic review identified 144 mapping studies reporting 190 algorithms mapping from 110 different source instruments to EQ-5D. Of the 17 studies published in 2016, nine (53%) had titles that followed the MAPS statement guidance, although only two (12%) had abstracts that fully addressed all MAPS items. When the full text of these papers was assessed against the complete MAPS checklist, only two studies (12%) were found to fulfil or partly fulfil all criteria. Of the 141 papers (across all years) that included abstracts, the items on the MAPS statement checklist that were fulfilled by the largest number of studies comprised having a structured abstract (95%) and describing target instruments (91%) and source instruments (88%). The number of published mapping studies continues to increase. Our updated database provides a convenient way to identify mapping studies for use in cost-utility analysis. Most recent studies do not fully address all items on the MAPS checklist.
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STORC safety initiative: a multicentre survey on preparedness & confidence in obstetric emergencies.
Guise, Jeanne-Marie; Segel, Sally Y; Larison, Kristine; M Jump, Sarah; Constable, Marion; Li, Hong; Osterweil, Patricia; Dieter Zimmer
2010-12-01
Patient safety is a national and international priority. The purpose of this study was to understand clinicians' perceptions of teamwork during obstetric emergencies in clinical practice, to examine factors associated with confidence in responding to obstetric emergencies and to evaluate perceptions about the value of team training to improve preparedness. An anonymous survey was administered to all clinical staff members who respond to obstetric emergencies in seven Oregon hospitals from June 2006 to August 2006. 614 clinical staff (74.5%) responded. While over 90% felt confident that the appropriate clinical staff would respond to emergencies, more than half reported that other clinical staff members were confused about their role during emergencies. Over 84% were confident that emergency drills or simulation-based team training would improve performance. Clinical staff who respond to obstetric emergencies in their practice reported feeling confident that the qualified personnel would respond to an emergency; however, they were less confident that the responders would perform well as a team. They reported that simulation and team training may improve their preparedness and confidence in responding to emergencies.
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Preventive care in general practice among healthy older New South Wales residents.
Harris, Mark F; Islam, Fakhrul Md; Jalaludin, Bin; Chen, Jack; Bauman, Adrian E; Comino, Elizabeth J
2013-06-16
Despite being at high risk, disadvantaged patients may be less likely to receive preventive care in general practice. This study aimed to explore self-reported preventive care received from general practitioners and the factors associated with this by healthy New South Wales (NSW) residents aged 45-74 years. A self-completed questionnaire was sent to 100,000 NSW residents in the 45 and Up cohort study. There was a 60% response rate. After exclusions there were 39,964 participants aged 45-74 years who did not report cardiovascular disease or diabetes. Dichotomised outcome variables were participant report of having had a clinical assessment of their blood pressure (BP), blood cholesterol (BC) or blood glucose (BG), or received advice to eat less high fat food, eat more fruit and vegetables or be more physically active from their GP in the last 12 months. Independent variables included socio-demographic, lifestyle risk factors, health status, access to health care and confidence in self-management. Most respondents reported having had their BP (90.6%), BC (73.9%) or BG (69.4%) assessed. Fewer reported being given health advice to (a)eat less high fat food (26.6%), (b) eat more fruit and vegetables (15.5%) or (c) do more physical activity (19.9%). The patterns of association were consistent with recognised need: participants who were older, less well educated or overweight were more likely to report clinical assessments; participants who were overseas born, of lower educational attainment, less confident in their own self-management, reported insufficient physical activity or were overweight were more likely to report receiving advice. However current smokers were less likely to report clinical assessments; and rural and older participants were less likely to receive diet or physical activity advice. This study demonstrated a gap between reported clinical assessments and preventive advice. There was evidence for inverse care for rural participants and smokers, who despite being at higher risk of health problems, were less likely to report receiving preventive care. This suggests the need for greater effort to promote preventive care for these groups in Australian general practice.
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Waters, Aoife Mi; Tudur Smith, Catrin; Young, Bridget; Jones, Terry M
2014-05-13
The incidence of oropharyngeal cancer is increasing in the developed world. This has led to a large rise in research activity and clinical trials in this area, yet there is no consensus on which outcomes should be measured. As a result, the outcomes measured often differ between trials of comparable interventions, making the combination or comparison of results between trials impossible. Outcomes may also be 'cherry-picked', such that favourable results are reported, and less favourable results withheld. The development of a minimum outcome reporting standard, known as a core outcome set, goes some way to addressing these problems. Core outcome sets are ideally developed using a patient-centred approach so that the outcomes measured are relevant to patients and clinical practice. Core outcome sets drive up the quality and relevance of research by ensuring that the right outcomes are consistently measured and reported in trials in specific areas of health or healthcare. This is a mixed methods study involving three phases to develop a core outcome set for oropharyngeal cancer clinical trials. Firstly, a systematic review will establish which outcomes are measured in published oropharyngeal cancer randomised controlled trials (RCTs). Secondly, qualitative interviews with patients and carers in the UK and the USA will aim to establish which outcomes are important to these stakeholders. Data from these first two stages will be used to develop a comprehensive list of outcomes to be considered for inclusion in the core outcome set. In the third stage, patients and clinicians will participate in an iterative consensus exercise known as a Delphi study to refine the contents of the core outcome set. This protocol lays out the methodology to be implemented in the CONSENSUS study. A core outcome set defines a minimum outcome reporting standard for clinical trials in a particular area of health or healthcare. Its consistent implementation in oropharyngeal cancer clinical trials will improve the quality and relevance of research. This study is registered at the National Institute for Health Research (NIHR) Clinical Research Network (CRN) portfolio, ID 13823 (17 January 2013).
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2014-01-01
Background The incidence of oropharyngeal cancer is increasing in the developed world. This has led to a large rise in research activity and clinical trials in this area, yet there is no consensus on which outcomes should be measured. As a result, the outcomes measured often differ between trials of comparable interventions, making the combination or comparison of results between trials impossible. Outcomes may also be ‘cherry-picked’, such that favourable results are reported, and less favourable results withheld. The development of a minimum outcome reporting standard, known as a core outcome set, goes some way to addressing these problems. Core outcome sets are ideally developed using a patient-centred approach so that the outcomes measured are relevant to patients and clinical practice. Core outcome sets drive up the quality and relevance of research by ensuring that the right outcomes are consistently measured and reported in trials in specific areas of health or healthcare. Methods/Design This is a mixed methods study involving three phases to develop a core outcome set for oropharyngeal cancer clinical trials. Firstly, a systematic review will establish which outcomes are measured in published oropharyngeal cancer randomised controlled trials (RCTs). Secondly, qualitative interviews with patients and carers in the UK and the USA will aim to establish which outcomes are important to these stakeholders. Data from these first two stages will be used to develop a comprehensive list of outcomes to be considered for inclusion in the core outcome set. In the third stage, patients and clinicians will participate in an iterative consensus exercise known as a Delphi study to refine the contents of the core outcome set. This protocol lays out the methodology to be implemented in the CONSENSUS study. Discussion A core outcome set defines a minimum outcome reporting standard for clinical trials in a particular area of health or healthcare. Its consistent implementation in oropharyngeal cancer clinical trials will improve the quality and relevance of research. Trials and registration This study is registered at the National Institute for Health Research (NIHR) Clinical Research Network (CRN) portfolio, ID 13823 (17 January 2013). PMID:24885068
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Risk of lymphoma in women with breast implants: analysis of clinical studies.
Largent, Joan; Oefelein, Michael; Kaplan, Hilton M; Okerson, Ted; Boyle, Peter
2012-05-01
Large studies suggest that the overall rate of lymphoma in women with breast implants is no greater than in the general population; clinical reports suggest an association between breast implants and the rare non-Hodgkin lymphoma, anaplastic large cell lymphoma (ALCL). Observed cases of lymphoma reported in Allergan-sponsored breast implant clinical studies were compared with expected cases on the basis of the incidence of lymphoma among women in the National Cancer Institute's Surveillance Epidemiology and End Results program, using standardized incidence ratios (SIRs) and 95% confidence intervals (CIs). In clinical studies, there were 28 observed cases of lymphoma among 89 382 patients and 204 682 person-years of follow-up compared with 43 expected cases [SIR: 28/43=0.65 (95% CI: 0.43-0.94), P=0.02]. SIRs were calculated stratifying by baseline cancer history: women without prior cancer [SIR: 17/24=0.70 (95% CI: 0.41-1.13), P=0.17] and women with prior cancer [SIR: 11/14=0.79 (95% CI: 0.39-1.41), P=0.52]. SIRs were calculated by implant shell type: textured shell implants [SIR: 16/23=0.70 (95% CI: 0.40-1.13), P=0.16] and smooth shell implants [SIR: 12/19=0.63 (95% CI: 0.33-1.10), P=0.12]. Surveillance Epidemiology and End Results reported 12 cases of primary breast ALCL in women between 1996 and 2007 without a history of cancer, for an average annual incidence of 4.28 (95% CI: 3.51-5.05)/100 million women in the US - these women may or may not have breast implants. In clinical studies, three ALCL cases were reported in women with breast implants and a history of breast cancer, yielding a crude incidence rate of 1.46 (95% CI: 0.30-4.3)/100 000 person-years. Large clinical studies, based on over 200 000 person-years of follow-up, suggest no evidence of an increased risk of lymphoma among women who have received breast implants.
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Clinical trial registration in physical therapy journals: a cross-sectional study.
Babu, Abraham Samuel; Veluswamy, Sundar Kumar; Rao, Pratiksha Tilak; Maiya, Arun G
2014-01-01
Clinical trial registration has become an important part of editorial policies of various biomedical journals, including a few physical therapy journals. However, the extent to which editorial boards enforce the need for trial registration varies across journals. The purpose of this study was to identify editorial policies and reporting of trial registration details in MEDLINE-indexed English-language physical therapy journals. This study was carried out using a cross-sectional design. Editorial policies on trial registration of MEDLINE-indexed member journals of the International Society of Physiotherapy Journal Editors (ISPJE) (Journal of Geriatric Physical Therapy, Journal of Hand Therapy, Journal of Neurologic Physical Therapy, Journal of Orthopaedic and Sports Physical Therapy, Journal of Physiotherapy [formerly Australian Journal of Physiotherapy], Journal of Science and Medicine in Sport, Manual Therapy, Physical Therapy, Physical Therapy in Sport, Physiotherapy, Physiotherapy Research International, Physiotherapy Theory and Practice, and Revista Brasileira de Fisioterapia) were reviewed in April 2013. Full texts of reports of clinical trials published in these journals between January 1, 2008, and December 31, 2012, were independently assessed for information on trial registration. Among the 13 journals, 8 recommended trial registration, and 6 emphasized prospective trial registration. As of April 2013, 4,618 articles were published between January 2008 and December 2012, of which 9% (417) were clinical trials and 29% (121/417) of these reported trial registration details. A positive trend in reporting of trial registration was observed from 2008 to 2012. The study was limited to MEDLINE-indexed ISPJE member journals. Editorial policies on trial registration of physical therapy journals and a rising trend toward reporting of trial registration details indicate a positive momentum toward trial registration. Physical therapy journal editors need to show greater commitment to prospective trial registration to make it a rule rather than an option.
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"Not just right experiences" in patients with Tourette syndrome: complex motor tics or compulsions?
Neal, Matthew; Cavanna, Andrea Eugenio
2013-12-15
Tourette syndrome (TS) is a chronic tic disorder often accompanied by specific obsessive-compulsive symptoms (OCS) or full-blown obsessive-compulsive disorder (OCD). Repetitive behaviours are commonly reported by patients with TS, who experience the urge to perform an action until it has been done "just right". This study investigated the clinical correlates of "not just right experiences" (NJREs) in this clinical population. A standardised battery of self-report psychometric measures was administered to 71 adult patients with TS recruited from a specialist TS clinic. NJREs were systematically screened for using the Not Just Right Experiences-Questionnaire Revised (NJRE-QR). The vast majority of patients in our clinical sample (n=57, 80%) reported at least one NJRE. Patients diagnosed with TS and co-morbid OCD/OCS (n=42, 59%) reported a significantly higher number of NJREs compared to TS patients without OCD/OCS. The strongest correlation was found between NJRE-QR scores and self-report measures of compulsivity. NJREs appear to be intrinsic to the clinical phenomenology of patients with TS and can present with higher frequency in the context of co-morbid OCD/OCS, suggesting they are more related to compulsions than tics. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.
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The Asthma Mobile Health Study, a large-scale clinical observational study using ResearchKit.
Chan, Yu-Feng Yvonne; Wang, Pei; Rogers, Linda; Tignor, Nicole; Zweig, Micol; Hershman, Steven G; Genes, Nicholas; Scott, Erick R; Krock, Eric; Badgeley, Marcus; Edgar, Ron; Violante, Samantha; Wright, Rosalind; Powell, Charles A; Dudley, Joel T; Schadt, Eric E
2017-04-01
The feasibility of using mobile health applications to conduct observational clinical studies requires rigorous validation. Here, we report initial findings from the Asthma Mobile Health Study, a research study, including recruitment, consent, and enrollment, conducted entirely remotely by smartphone. We achieved secure bidirectional data flow between investigators and 7,593 participants from across the United States, including many with severe asthma. Our platform enabled prospective collection of longitudinal, multidimensional data (e.g., surveys, devices, geolocation, and air quality) in a subset of users over the 6-month study period. Consistent trending and correlation of interrelated variables support the quality of data obtained via this method. We detected increased reporting of asthma symptoms in regions affected by heat, pollen, and wildfires. Potential challenges with this technology include selection bias, low retention rates, reporting bias, and data security. These issues require attention to realize the full potential of mobile platforms in research and patient care.
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Analysis of the sex ratio of reported gonorrhoea incidence in Shenzhen, China
Xiong, Mingzhou; Lan, Lina; Feng, Tiejian; Zhao, Guanglu; Wang, Feng; Hong, Fuchang; Wu, Xiaobing; Zhang, Chunlai; Wen, Lizhang; Liu, Aizhong; Best, John McCulloch; Tang, Weiming
2016-01-01
Objective To assess the clinical process of gonorrhoea diagnosis and report in China, and to determine the difference of sex ratio between reported incidence based on reporting data and true diagnosis rate based on reference tests of gonorrhoea. Setting A total of 26 dermatology and sexually transmitted disease (STD) departments, 34 obstetrics-gynaecology clinics and 28 urology outpatient clinics selected from 34 hospitals of Shenzhen regarded as our study sites. Participants A total of 2754 participants were recruited in this study, and 2534 participants completed the questionnaire survey and provided genital tract secretion specimens. There were 1106 male and 1428 female participants. Eligible participants were patients who presented for outpatient STD care at the selected clinics for the first time in October 2012 were at least 18 years old, and were able to give informed consent. Outcome measures Untested rate, true-positive rate, false-negative rate and unreported rate of gonorrhoea, as well as reported gonorrhoea incidence sex ratio and true diagnosis sex ratio were calculated and used to describe the results. Results 2534 participants were enrolled in the study. The untested rate of gonorrhoea among females was significantly higher than that among males (female 88.1%, male 68.3%, p=0.001). The male-to-female sex ratios of untested rate, true-positive rate, false-negative rate and unreported rate were 1:1.3, 1.2:1, 1:1.6 and 1:1.4, respectively. The reported gonorrhoea incidence sex ratio of new diagnosed gonorrhoea was 19.8:1 (male vs female: 87/1106 vs 5/1420), while the true diagnosis sex ratio was 2.5:1 (male vs female: 161/1106 vs 84/1420). These data indicate that the sex ratio of reported gonorrhoea incidence has been overestimated by a factor of 7.9 (19.8/2.5). Conclusions We found the current reported gonorrhoea incidence and sex ratios to be inaccurate due to underestimations of gonorrhoea incidence, especially among women. PMID:26975933
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Carter, Allison; de Pokomandy, Alexandra; Loutfy, Mona; Ding, Erin; Sereda, Paul; Webster, Kath; Nicholson, Valerie; Beaver, Kerrigan; Hogg, Robert S; Kaida, Angela
2017-03-24
We assessed the validity of a self-report measure of undetectable viral load (VL) among women with HIV in British Columbia (BC), Canada. Questionnaire data from the Canadian HIV Women's Sexual and Reproductive Health Cohort Study was linked with population-based clinical data from the BC Centre for Excellence in HIV/AIDS. Self-reported undetectable VL was assessed by the question: "What was your most recent VL, undetectable (i.e. <50 copies/mL) or detectable (i.e. ≥50 copies/mL)?" Laboratory measurements of VL <50 copies/mL (closest to/before study visit) were the criterion for validity analyses. We measured positive and negative predictive values (PPV, NPV) and likelihood ratios (LR+, LR-). Of 356 participants, 99% were linked to clinical data. Those unlinked (n = 1), missing self-report VL (n = 18), or missing self-report and laboratory VL (n = 1) were excluded. Among the remaining 336: median age was 44 (IQR 37-51); 96% identified as cis-gender; 84% identified as heterosexual; and 45% identified as Indigenous, 40% White, 8% African, Caribbean, or Black, and 8% other/multiple ethnicities. Overall, 85% self-reported having an undetectable VL while 82% had clinical data indicating viral suppression. The PPV was 93.7 (95% CI 90.2-96.2) indicating that 94% of women who self-reported being undetectable truly were. The NPV was 80.4 (95% CI 66.9-90.2). LR+ was 3.2 (2.1-4.6) and LR- was 0.05 (0.03-0.10). Our self-report measure assessing undetectable VL strongly predicted true viral suppression among Canadian women with HIV. This measure can be used in research settings without laboratory data in regions with high rates of VL testing and suppression.
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Cooper, Dale J; Scammell, Brigitte E; Batt, Mark E; Palmer, Debbie
2018-01-17
The impracticalities and comparative expense of carrying out a clinical assessment is an obstacle in many large epidemiological studies. The purpose of this study was to develop and validate a series of electronic self-reported line drawing instruments based on the modified Beighton scoring system for the assessment of self-reported generalised joint hypermobility. Five sets of line drawings were created to depict the 9-point Beighton score criteria. Each instrument consisted of an explanatory question whereby participants were asked to select the line drawing which best represented their joints. Fifty participants completed the self-report online instrument on two occasions, before attending a clinical assessment. A blinded expert clinical observer then assessed participants' on two occasions, using a standardised goniometry measurement protocol. Validity of the instrument was assessed by participant-observer agreement and reliability by participant repeatability and observer repeatability using unweighted Cohen's kappa (k). Validity and reliability were assessed for each item in the self-reported instrument separately, and for the sum of the total scores. An aggregate score for generalised joint hypermobility was determined based on a Beighton score of 4 or more out of 9. Observer-repeatability between the two clinical assessments demonstrated perfect agreement (k 1.00; 95% CI 1.00, 1.00). Self-reported participant-repeatability was lower but it was still excellent (k 0.91; 95% CI 0.74, 1.00). The participant-observer agreement was excellent (k 0.96; 95% CI 0.87, 1.00). Validity was excellent for the self-report instrument, with a good sensitivity of 0.87 (95% CI 0.81, 0.91) and excellent specificity of 0.99 (95% CI 0.98, 1.00). The self-reported instrument provides a valid and reliable assessment of the presence of generalised joint hypermobility and may have practical use in epidemiological studies.
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A Manpower Study of Technical Personnel in Hospital Clinical Laboratories. Final Report.
ERIC Educational Resources Information Center
Harkness, James P., And Others
As one of the efforts related to closing the gap between the growing demands for clinical laboratory workers and the supply of well-trained workers, the volume and quality of laboratory procedures and the general characteristics of workers in North Carolina hospitals were studied. Approaches to the study included tests on "unknowns" by…
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Tafelski, Sascha; Kerper, Léonie F; Salz, Anna-Lena; Spies, Claudia; Reuter, Eva; Nachtigall, Irit; Schäfer, Michael; Krannich, Alexander; Krampe, Henning
2016-07-01
Previous studies reported conflicting results concerning different pain perceptions of men and women. Recent research found higher pain levels in men after major surgery, contrasted by women after minor procedures. This trial investigates differences in self-reported preoperative pain intensity between genders before surgery.Patients were enrolled in 2011 and 2012 presenting for preoperative evaluation at the anesthesiological assessment clinic at Charité University hospital. Out of 5102 patients completing a computer-assisted self-assessment, 3042 surgical patients with any preoperative pain were included into this prospective observational clinical study. Preoperative pain intensity (0-100 VAS, visual analog scale) was evaluated integrating psychological cofactors into analysis.Women reported higher preoperative pain intensity than men with median VAS scores of 30 (25th-75th percentiles: 10-52) versus 21 (10-46) (P < 0.001). Adjusted multiple regression analysis showed that female gender remained statistically significantly associated with higher pain intensity (P < 0.001). Gender differences were consistent across several subgroups especially with varying patterns in elderly. Women scheduled for minor and moderate surgical procedures showed largest differences in overall pain compared to men.This large clinical study observed significantly higher preoperative pain intensity in female surgical patients. This gender difference was larger in the elderly potentially contradicting the current hypothesis of a primary sex-hormone derived effect. The observed variability in specific patient subgroups may help to explain heterogeneous findings of previous studies.
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Wolowacz, Sorrel E; Briggs, Andrew; Belozeroff, Vasily; Clarke, Philip; Doward, Lynda; Goeree, Ron; Lloyd, Andrew; Norman, Richard
Cost-utility models are increasingly used in many countries to establish whether the cost of a new intervention can be justified in terms of health benefits. Health-state utility (HSU) estimates (the preference for a given state of health on a cardinal scale where 0 represents dead and 1 represents full health) are typically among the most important and uncertain data inputs in cost-utility models. Clinical trials represent an important opportunity for the collection of health-utility data. However, trials designed primarily to evaluate efficacy and safety often present challenges to the optimal collection of HSU estimates for economic models. Careful planning is needed to determine which of the HSU estimates may be measured in planned trials; to establish the optimal methodology; and to plan any additional studies needed. This report aimed to provide a framework for researchers to plan the collection of health-utility data in clinical studies to provide high-quality HSU estimates for economic modeling. Recommendations are made for early planning of health-utility data collection within a research and development program; design of health-utility data collection during protocol development for a planned clinical trial; design of prospective and cross-sectional observational studies and alternative study types; and statistical analyses and reporting. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
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Jain, Raka; Jhanjee, Sonali; Jain, Veena; Gupta, Tina; Mittal, Swati; Chauhan, Prashant; Raghav, Rahul; Goelz, Patricia; Schnoll, Robert A
2015-01-01
The validity of self-reported tobacco use is often questioned given the potential for underestimation of use. This study used data from a double-blind, placebo-controlled clinical trial of varenicline for smokeless tobacco dependence in India to evaluate the accuracy of self-reported smokeless tobacco cessation using biochemical validation procedures and to evaluate correlates of reporting inaccuracy. Smokeless tobacco users attending a dental clinic at AIIMS were randomized to placebo or varenicline; all participants received counseling. Detailed smokeless tobacco use was recorded and abstinence was defined as cotinine-verified 7-day point prevalence cessation (cotinine < 50 ng/ml) and breath CO > 10 ppm at the end of 12 weeks of treatment. One-half of study completers (82/165) self-reported abstinence. Biochemical verification confirmed that (65.9%) subjects provided accurate self-reports while (34.1%) participants underreported tobacco use. These data indicate poor agreement between self-reported and biochemically confirmed abstinence (κ = -0.191). Underreporters of tobacco use had significantly higher baseline cotinine (p < 0.05), total craving (p < 0.012), and negative reinforcement craving (p < 0.001) vs. those whose self-reports were correctly verified. These findings provide evidence to support the need for biochemical validation of self-reported abstinence outcomes among smokeless tobacco users in cessation programs in India and identify high levels of pretreatment cotinine and craving levels as potential correlates of false reporting.
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Baker, J R; Hudson, J L
2015-01-01
Whilst shy, socially anxious or socially withdrawn children in nonclinical community samples report lower friendship quality (FQ) than nonanxious children, no study has examined the FQ of clinically anxious children. The aim of the study was to examine the FQ of children with anxiety disorders; and whether it differs for clinical children with or without a diagnosis of social phobia (SP). The study design was cross-sectional self-report. Clinical children - 39 anxiety-disordered children with SP and 28 anxiety-disordered children without SP (No-SP) - presented for psychological treatment, and 29 nonclinical children were recruited from the community. Same-sex close friends were invited to participate using an unrestricted nomination procedure. All children were aged between 7 and 13 years. Both target child and friend completed the Friendship Quality Questionnaire and the Spence Children's Anxiety Scale. Using multilevel modeling within the framework of the Actor-Partner Interdependence Model, SP dyads were found to report lower overall FQ than No-SP dyads. SP dyads did not report lower overall FQ than nonclinical dyads. Children with SP in their diagnostic profile may be unique in their friendship experiences relative to children with other anxiety disorders.
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Father involvement and psychological well-being of pregnant women
Giurgescu, Carmen; Templin, Thomas
2015-01-01
Purpose This study examined the relationships among father of the baby involvement during pregnancy, depressive symptoms and psychological well-being in African American women. Study Design and Methods Using a prospective study design, a sample of 95 pregnant African American women receiving prenatal care at a medical center in Chicago completed the self-report instruments about father of the baby involvement, depressive symptoms, and psychological well-being twice during pregnancy; once at between 15-25 and once between 25-37 weeks. Results Eighty percent of women reported that the father of the baby was involved during their pregnancy. Twenty-eight percent of women had clinically relevant depressive symptoms (CES-D scores ≥16) at the first data collection and 25% of women had clinically relevant depressive symptoms at the second data collection. Compared with women who reported no father involvement during pregnancy, women who reported father involvement during pregnancy had lower levels of depressive symptoms and higher levels of psychological well-being. Clinical Implications Fathers' involvement is important during pregnancy; nurses should encourage fathers to participate at prenatal visits and ask questions and educate fathers on pregnancy process and procedures during prenatal care. PMID:26488855
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Morrison, Janet D; Becker, Heather; Stuifbergen, Alexa K
2017-12-01
Careful consideration of intervention fidelity is critical to establishing the validity and reliability of research findings, yet such reports are often lacking in the research literature. It is imperative that intervention fidelity be methodically evaluated and reported to promote the translation of effective interventions into sound evidence-based practice. The purpose of this article is to explore strategies used to promote intervention fidelity, incorporating examples from a multisite clinical trial, that illustrate the National Institutes of Health Behavior Change Consortium's 5 domains for recommended treatment practices: (1) study design, (2) facilitator training, (3) intervention delivery, (4) intervention receipt, and (5) intervention enactment. A multisite randomized clinical trial testing the efficacy of a computer-assisted cognitive rehabilitation intervention for adults with multiple sclerosis is used to illustrate strategies promoting intervention fidelity. Data derived from audiotapes of intervention classes, audits of computer exercises completed by participants, participant class attendance, and goal attainment scaling suggested relatively high fidelity to the intervention protocol. This study illustrates how to report intervention fidelity in the literature guided by best practice strategies, which may serve to promote fidelity monitoring and reporting in future studies.
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Wall, Stephen P; Mayorga, Oliver; Banfield, Christine E; Wall, Mark E; Aisic, Ilan; Auerbach, Carl; Gennis, Paul
2006-11-01
To develop software that categorizes electronic head computed tomography (CT) reports into groups useful for clinical decision rule research. Data were obtained from the Second National Emergency X-Radiography Utilization Study, a cohort of head injury patients having received head CT. CT reports were reviewed manually for presence or absence of clinically important subdural or epidural hematoma, defined as greater than 1.0 cm in width or causing mass effect. Manual categorization was done by 2 independent researchers blinded to each other's results. A third researcher adjudicated discrepancies. A random sample of 300 reports with radiologic abnormalities was selected for software development. After excluding reports categorized manually or by software as indeterminate (neither positive nor negative), we calculated sensitivity and specificity by using manual categorization as the standard. System efficiency was defined as the percentage of reports categorized as positive or negative, regardless of accuracy. Software was refined until analysis of the training data yielded sensitivity and specificity approximating 95% and efficiency exceeding 75%. To test the system, we calculated sensitivity, specificity, and efficiency, using the remaining 1,911 reports. Of the 1,911 reports, 160 had clinically important subdural or epidural hematoma. The software exhibited good agreement with manual categorization of all reports, including indeterminate ones (weighted kappa 0.62; 95% confidence interval [CI] 0.58 to 0.65). Sensitivity, specificity, and efficiency of the computerized system for identifying manual positives and negatives were 96% (95% CI 91% to 98%), 98% (95% CI 98% to 99%), and 79% (95% CI 77% to 80%), respectively. Categorizing head CT reports by computer for clinical decision rule research is feasible.
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Nieri, Michele; Clauser, Carlo; Franceschi, Debora; Pagliaro, Umberto; Saletta, Daniele; Pini-Prato, Giovanpaolo
2007-08-01
The aim of the present study was to investigate the relationships among reported methodological, statistical, clinical and paratextual variables of randomized clinical trials (RCTs) in implant therapy, and their influence on subsequent research. The material consisted of the RCTs in implant therapy published through the end of the year 2000. Methodological, statistical, clinical and paratextual features of the articles were assessed and recorded. The perceived clinical relevance was subjectively evaluated by an experienced clinician on anonymous abstracts. The impact on research was measured by the number of citations found in the Science Citation Index. A new statistical technique (Structural learning of Bayesian Networks) was used to assess the relationships among the considered variables. Descriptive statistics revealed that the reported methodology and statistics of RCTs in implant therapy were defective. Follow-up of the studies was generally short. The perceived clinical relevance appeared to be associated with the objectives of the studies and with the number of published images in the original articles. The impact on research was related to the nationality of the involved institutions and to the number of published images. RCTs in implant therapy (until 2000) show important methodological and statistical flaws and may not be appropriate for guiding clinicians in their practice. The methodological and statistical quality of the studies did not appear to affect their impact on practice and research. Bayesian Networks suggest new and unexpected relationships among the methodological, statistical, clinical and paratextual features of RCTs.
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Stargardt, Tom; Gonder-Frederick, Linda; Krobot, Karl J; Alexander, Charles M
2009-01-01
Background To explore the concept of the Minimum Clinically Important Difference (MID) of the Worry Scale of the Hypoglycaemia Fear Survey (HFS-II) and to quantify the clinical importance of different types of patient-reported hypoglycaemia. Methods An observational study was conducted in Germany with 392 patients with type 2 diabetes mellitus treated with combinations of oral anti-hyperglycaemic agents. Patients completed the HFS-II, the Treatment Satisfaction Questionnaire for Medication (TSQM), and reported on severity of hypoglycaemia. Distribution- and anchor-based methods were used to determine MID. In turn, MID was used to determine if hypoglycaemia with or without need for assistance was clinically meaningful compared to having had no hypoglycaemia. Results 112 patients (28.6%) reported hypoglycaemic episodes, with 15 patients (3.8%) reporting episodes that required assistance from others. Distribution- and anchor-based methods resulted in MID between 2.0 and 5.8 and 3.6 and 3.9 for the HFS-II, respectively. Patients who reported hypoglycaemia with (21.6) and without (12.1) need for assistance scored higher on the HFS-II (range 0 to 72) than patients who did not report hypoglycaemia (6.0). Conclusion We provide MID for HFS-II. Our findings indicate that the differences between having reported no hypoglycaemia, hypoglycaemia without need for assistance, and hypoglycaemia with need for assistance appear to be clinically important in patients with type 2 diabetes mellitus treated with oral anti-hyperglycaemic agents. PMID:19849828
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Krakow, Barry; Ulibarri, Victor A
2013-03-01
Few studies have examined the co-morbidity between insomnia and sleep-disordered breathing in the clinical setting. This study evaluated treatment-seeking insomnia patients and their self-report of sleep breathing complaints. A retrospective chart review was conducted on 1,035 consecutive treatment-seeking, chronic insomnia patients who reported insomnia as their primary problem upon seeking care at a private, community-based sleep medical center. Measurements included the insomnia severity index, standard subjective sleep measures as well as rankings, attributions, and self-reports about sleep breathing disorders, problems, and symptoms. A total of 1,035 adult, treatment-seeking insomnia patients indicated insomnia interfered with daytime functioning, and their average insomnia severity was in the range of a clinically relevant problem: total sleep time (5.50 h, SD = 1.60), sleep efficiency (71.05 %, SD = 18.26), wake time after sleep onset (120.70 min, SD = 92.56), and an insomnia severity index (18.81, SD = 5.09). Of these 1,035 insomnia patients, 42 % also ranked a sleep breathing disorder among their list of reasons for seeking treatment, another 13 % revealed a concern about a sleep breathing problem, and another 26 % reported awareness of sleep breathing symptoms. Only 19 % of this clinical insomnia sample reported no awareness or concerns about sleep breathing disorders, problems, or symptoms. A greater proportion of men than women reported significantly more sleep breathing disorders, problems, or symptoms. Sleep breathing complaints were extremely common among a large sample of treatment-seeking, self-identified, adult chronic insomnia patients. Prospective prevalence research is needed to corroborate or revise these findings, and polysomnography should be considered in appropriate cohorts to determine the clinical relevance of treatment-seeking chronic insomnia patients' sleep breathing complaints.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Basch, Ethan, E-mail: ebasch@med.unc.edu; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina; Pugh, Stephanie L.
Purpose: To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Methods and Materials: Patients enrolled in NRG Oncology's RTOG 1012 (Prophylactic Manuka Honey for Reduction of Chemoradiation Induced Esophagitis-Related Pain during Treatment of Lung Cancer) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly ×4 during treatment; 12 weeks after treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visitsmore » when an expected PRO-CTCAE assessment was completed. Results: Among 226 study sites participating in RTOG 1012, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients, of which 34 (43%) required tablet computers to be provided. All 152 patients in RTOG 1012 agreed to self-report using the PRO-CTCAE (median age 66 years; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range, 30-240 minutes), and median time for CRAs to teach a patient to self-report was 10 minutes (range, 2-60 minutes). Compliance was high, particularly during active treatment, when patients self-reported at 86% of expected time points, although compliance was lower after treatment (72%). Common reasons for noncompliance were institutional errors, such as forgetting to provide computers to participants; patients missing clinic visits; Internet connectivity; and patients feeling “too sick.” Conclusions: Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic AEs at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be obviated by allowing patients to self-report electronically between visits, and by using central compliance monitoring. These approaches are being incorporated into ongoing studies.« less